Polsinelli

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900 W. 48th Place
Suite 900
Kansas City, MO 64112, United States
Phone: 816.753.1000
Fax: (816) 753-1536
Areas Of Practice
  • Agriculture
  • Alternative Dispute Resolution (ADR)
  • Antitrust & Trade Regulation
  • Appellate Practice
  • Art, Entertainment, & Sports Law
  • Bankruptcy
  • Business Organizations
  • Class Action
  • Commercial Law & Contracts
  • Communications & Media Law
  • Construction Law
  • Criminal Law
  • Debtor/Creditor
  • Energy & Utilities
  • Environmental Law
  • Finance & Banking
  • Government
  • Health
  • Immigration Law
  • Insurance
  • Intellectual Property
  • International Law & Trade
  • Labor & Employment Law
  • Litigation
  • Mergers & Acquisitions
  • Privacy
  • Products Liability
  • Professional Malpractice
  • Real Estate
  • Science, Computers, & Tech
  • Securities Law
  • Taxation
  • Toxic Torts
  • Wills, Trusts, & Estate Planning
  • Zoning, Planning & Land Use
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Locations
Other U.S. Locations
  • Arizona
  • California
  • Colorado
  • D.C.
  • Delaware
  • Florida
  • Georgia
  • Illinois
  • Massachusetts
  • Missouri
  • New York
  • North Carolina
  • Tennessee
  • Texas
  • Utah
  • Washington
Number of Attorneys
1,000+ Attorneys

Who Would Have Predicted It? Polymarket Settles for Operating Unregistered Swap Execution Facility

On January 3, 2022, the Commodity Futures Trading Commission (CFTC) announced an order against and settlement with Polymarket, a blockchain-enabled prediction market that allows users to “bet” on the occurrence of certain future…more

Blockchain, CFTC, Designated Contract Markets (DCMs), Enforcement Actions, Financial Markets

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National Security Focus on Cybersecurity for Critical Infrastructure Sharpens

Last year Colonial Pipeline halted one of the United States’ largest pipeline systems due to a ransomware attack. Within days a state of emergency was declared in 17 states. A few days later the pipeline resumed service, and…more

Biden Administration, Critical Infrastructure Sectors, Cyber Attacks, Cybersecurity, Executive Orders

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How Final Do You Want It To Be?: Recent Change To American Arbitration Association Rules Allows For Appeals In Certain Cases

In a prior e-Alert, the Commercial Litigation practice outlined the issues confronting your business when deciding whether to enter into a contractual arbitration agreement. The alert noted that an important issue to consider is…more

American Arbitration Association, Appeals, Arbitration

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Supreme Court Opens the Doors for States to Tax More Online Sales

On Thursday, June 21, 2018, The Supreme Court of the United States issued its decision in the landmark South Dakota v. Wayfair, Inc. case, drastically changing the law for e-commerce and remote sellers…more

Appeals, Commerce Clause, Constitutional Challenges, Internet Retailers, Interstate Commerce

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U.S. Federal Privacy Bill Unveiled

On April 5, 2024 members of U.S. Congress released a draft bipartisan, bicameral federal privacy bill, the American Privacy Rights Act. In a press release, the stated goal of this legislation is to be “a national data privacy…more

Consumer Privacy Rights, Data Brokers, Data Management, Data Privacy, Data Processors

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New Form 5500 Rules Permit More Plans to Qualify for Audit Exemption

The Department of Labor, Internal Revenue Service, and Pension Benefit Guaranty Corporation recently issued final rules on employee benefit plan annual reporting requirements that are effective for plan years beginning on or…more

401k, 403(b) Plans, Compensation & Benefits, Department of Labor (DOL), Employee Benefits

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Group Health Plan Coverage Requirements Expanded to Include Non-Prescribed Over-the-Counter COVID-19 Testing

Effective January 15, 2022, health plans are required to cover the cost of over-the-counter (“OTC”) COVID-19 test kits obtained without a health care provider’s prescription or clinical assessment. This new requirement was…more

Compensation & Benefits, Coronavirus/COVID-19, Cost-Sharing, Employee Benefits, Employer Group Health Plans

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IRS Says: New Goal is to Restore Fairness by Using Tax Dollars to Audit More Millionaires, Partnerships and Large Corporations

Following our initial reaction to the Internal Revenue Service's strategic operating plan to spend $80B in funding allocated from the Inflation Reduction Act, Polsinelli’s Tax attorneys continue to monitor the IRS’ compliance…more

Artificial Intelligence, High Net-Worth, Income Taxes, Inflation Reduction Act (IRA), Internal Revenue Code (IRC)

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The Polsinelli Pulse: Mitigating Litigation Risk at the Deal Table and Beyond - Vol. 3

Mergers & Acquisitions And Paycheck Protection Program: Proceed With Caution - In Spring 2020, Congress adopted the CARES Act, which authorized $350 billion for the Paycheck Protection Program (“PPP”). With an additional $310…more

Acquisition Agreements, C-Suite Executives, CARES Act, Coronavirus/COVID-19, Cyber Insurance

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

See all updates »

A Vaccine is Coming: Can Employers Require Employees to Take it?

As clinical trials continue across the world for a COVID-19 vaccine, many employers are asking whether they will be able to require employees to take the vaccine when it becomes available in the United States. Like with so many…more

Americans with Disabilities Act (ADA), Best Management Practices, Civil Rights Act, Coronavirus/COVID-19, Employee Rights

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Supreme Court Confirms the AIA On-Sale Bar Covers Secret Sales—But Invites Controversy over What Is “Otherwise Available to the Public.”

The Supreme Court recently issued its closely-watched decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., which has direct implications regarding the scope of § 102 prior art under the America Invents Act…more

America Invents Act, Appeals, Assignment of Inventions, Confidentiality Agreements, Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc

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Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

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H-1B Cap Season in Full Swing

Engaging and retaining smart, competitively trained, and diverse talent is critical for all businesses competing in a global economy. For many U.S. businesses across all industries, this means employing foreign workers who have…more

Department of Labor (DOL), Foreign Workers, H-1B, Highly-Skilled Workers Visa, USCIS

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FTC and DOJ Signal Greatly Increased Scrutiny of Private Equity Firms’ Acquisitions in Health Care

The top enforcers at the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) are sending strong signals that private equity (PE) firms are likely to be the next target in the Biden…more

Acquisitions, Antitrust Provisions, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Department of Justice (DOJ)

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Mitigating Your Greatest Data Privacy Risk

Third-party vendors pose a significant risk - The greatest data privacy threat to companies is commonly thought to be that company’s employees. While employees can be a threat, the majority of data breaches and intrusions…more

Data Breach, Data Privacy, Data Protection, Information Security, Information Technology

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Silicon Valley Bank Receivership

1. What happened Friday? a. The California Department of Financial Protection and Innovation closed Silicon Valley Bank (SVB) and appointed FDIC as receiver…more

Banks, Deposit Accounts, Depository Institutions, Enforcement Actions, FDIC

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The Devil's Dictionary of Bankruptcy Terms: Fraudulent Transfer

Fraudulent Transfer: A transfer by the debtor (including the incurring of an obligation by the debtor) voidable under Section 548 or under state law imported into the bankruptcy case through Section 544…more

Bankruptcy Code, Commercial Bankruptcy, Fraudulent Transfers, UFTA

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Proposed Regulations Expand Definition Of Real Estate For REITS To Include Solar Sites

In This Issue: - Solar Sites - The Proposed Regulations - Intangible Assets - Distinct Assets - Examples in the Proposed Regulations - Effective Date - Excerpt from Solar Sites: A key…more

Property Tax, Proposed Regulation, Real Estate Investments, REIT, Solar Energy

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Designers, Contractors and Insurers Take Note: Recent Amendment to IL Statute of Repose Strips Asbestos Defense, Exposes Decades of Liability

On December 19, 2014 the Illinois legislature amended the Illinois construction statute of repose to eliminate its protection in asbestos exposure cases (Public Act 098-1131). Beginning June 1, 2015, design professionals and…more

Amended Regulation, Asbestos, Construction Industry, Statute of Repose

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CMS “Goes Fishing” on Stark Law’s Impediments to Value-Based, Coordinated Care

On June 20, 2018, the Centers for Medicare & Medicaid Services and Department of Health and Human Services issued a “request for information” (RFI) seeking input on strategies to reduce the burden of the federal physician…more

Alternative Payment Models (APM), Centers for Medicare & Medicaid Services (CMS), Fee-for-Service, Health Care Providers, Request For Information

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SCOTUS Rejects Defense-Friendly Scienter Standard In Schutte Opinion

On June 1, 2023, the Supreme Court of the United States (SCOTUS) issued its much-anticipated opinion in United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc. (Schutte), holding that a…more

Drug Pricing, False Claims Act (FCA), Fraud, Government Investigations, Healthcare

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CMS Proposes Changes to Medicare Provider Enrollment Rules

The Centers for Medicare & Medicaid Services (“CMS”) published proposed changes to the Medicare Provider Enrollment requirements in the 2024 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”). If finalized, the…more

Centers for Medicare & Medicaid Services (CMS), Comment Period, Enrollment, Health Insurance, Healthcare

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Med-Staff Newsletter - August 2022 | VOL 10

Whether you are new to medical staff leadership or have served in the past and have been called to serve again, there are times when you will need to consult a lawyer who specializes in medical staff matters. While there is…more

Abortion, ADEA, Coronavirus/COVID-19, Dobbs v. Jackson Women’s Health Organization, Employer Liability Issues

See all updates »

Using Endowed Funds in a Crisis: Key Considerations

It goes without saying that we are living in uncertain times and are experiencing events that are reshaping our lives in ways that many of us believed only to exist in science fiction books and movies. Nevertheless, while we all…more

Charitable Organizations, Coronavirus/COVID-19, Endowment Funds

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COVID-19 Challenges Medical Equipment Supply Chains

The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment…more

Coronavirus/COVID-19, Customs and Border Protection, Export Controls, FEMA, Imports

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Brand Protection for Start-Up Breweries: A Six-Pack of Tips

As most brewery owners already know, your brand is a crucial business asset that takes a great deal of time, energy and money to establish. There are many things to consider when developing a brand strategy for your brewery;…more

Young Lawyers

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

See all updates »

Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act). The…more

Comment Period, Drug Compounding, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), Pharmaceutical Industry

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Health Care Reimbursement and Payor Dispute Update - September 2022

Co-Location and the Provider-Based Rules – No News is…Good News? On July 15, the Centers for Medicare & Medicaid Services ("CMS") released the 2023 Outpatient Prospective Payment System proposed rule (“OPPS Proposed Rule”),…more

Centers for Medicare & Medicaid Services (CMS), Critical Access Hospitals, Health Care Providers, Health Insurance, Healthcare

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Pharmacy Benefit Managers Licensing and Compliance Developments

In response to calls for greater transparency in the prescription drug industry, 2021 continued a nationwide trend of increased state licensing and regulation of Pharmacy Benefit Managers (“PBMs”). In the last year, laws…more

Health Insurance, Insurance Regulations, Licensing Rules, New Legislation, Pharmaceutical Industry

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Design Patent Holders Rejoice, but Challengers Face an Uphill Battle

Design patent holders can rejoice, for now, as the Federal Circuit reinforces its stance on the invalidity of design patents based on obviousness. On January 20, 2023, the Federal Circuit upheld a decades old rule that governs…more

Design Patent, Intellectual Property Protection, Obviousness, Patent Infringement, Patent Invalidity

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California Supreme Court Expands PAGA Standing

On March 12, 2020, the California Supreme Court broadened the scope of who can bring a representative action claiming penalties under the 2004 Private Attorneys General Act (PAGA)…more

CA Supreme Court, Class Representatives, Employer Liability Issues, Labor Code, Labor Law Violations

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COVID-19 and Its Growing Impact on Commercial Contracts: How Should Contracting Parties Respond?

COVID-19 is causing a rapidly evolving public health crisis, and businesses face uncertainty about their commercial relationships. That uncertainty is raising questions about performance under contractual agreements that were…more

Business Interruption, China, Commercial General Liability Policies, Commercial Insurance Policies, Commercial Loans

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SEC Significantly Modifies Disclosure Rules for Mining Companies

On October 31, 2018, the United States Securities and Exchange Commission (SEC) amended its rules to revise and modernize disclosure requirements applicable to companies with mining properties or operations…more

Disclosure Requirements, Energy Sector, Gas Royalties, Mineral Exploration, Mining

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St. Luke's Health: Does Improving Patient Care Justify a Merger Under Antitrust Law? Ninth Circuit Says "No" and Orders Divestiture

Healthcare providers frequently consolidate to cut costs and improve patient care. These benefits can result from sharing administrative costs such as billing and electronic recordkeeping, eliminating excess capacity, better…more

Antitrust Provisions, Divestiture, Federal Trade Commission (FTC), Hospital Mergers, Hospitals

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Estate Planning During Periods of Inflation and Market Volatility

Earlier this year the stock market entered bear market territory.  This happens when the market declines more than 20% or more from its most recent high.  The market decline has been attributed to several factors including…more

Charitable Remainder Trust, Estate Planning, Estate Tax, Estate-Tax Exemption, Gift Tax

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What is 13th Month Pay and Why Should Employers Care?

Most American employers run payroll twelve or twenty-four times across a calendar year. In some countries, there is a “thirteenth month” to think about…more

Bonuses, Employer Responsibilities, International Labor Laws, Payroll Taxes, Salaried Employees

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The EEOC Issues its Final Rule about the Pregnant Workers Fairness Act

On April 15, 2024, the EEOC issued its final rule regarding the implementation of the Pregnant Workers Fairness Act (the “PWFA”), a law that went into effect on June 27, 2023. The final rule will be officially published in the…more

Employee Rights, Employer Liability Issues, Equal Employment Opportunity Commission (EEOC), Final Rules, Pregnancy

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Florida Legislative Session 2024: Health Care Highlights

The Florida Regular Legislative Session began on January 9, 2024, and ended on March 8, 2024. Below is a summary of relevant health care laws that will be effective July 1, 2024, if they are approved by Governor DeSantis…more

Cancer, Employee Benefits, Florida, Health Care Providers, Health Insurance

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Assessing New Risks in Letters of Intent - Delaware Supreme Court Creates Increased Exposure by Recognizing a Duty to Negotiate in Good Faith

Prior to entering into a definitive commercial agreement, parties often enter into a letter of intent, a term sheet or a memorandum of understanding (a preliminary agreement). Some of the provisions in the preliminary agreement…more

Agreement To Negotiate, Commercial Contracts, Contract Negotiations, DE Supreme Court, Good Faith

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California Supreme Court Adopts New Independent Contractor Analysis

On April 30, 2018, the California Supreme Court adopted a new test to establish independent contractor status pursuant to the California Industrial Wage Orders. In Dynamex Operations W. v. Superior Court, 2018 WL 1999120 (Cal…more

ABC Test, CA Supreme Court, Employee Definition, Employer Liability Issues, Employment Litigation

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Six Steps Employers Can Take In Advance of a DOL Audit

If an employer is being audited by the US Department of Labor (DOL), there are several steps the employer can take to proactively prepare for and ultimately defend its practices..…more

Audits, Data Protection, Department of Labor (DOL), Family and Medical Leave Act (FMLA), Intellectual Property Protection

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Florida Legal Update: Laws of Interest Effective July 1, 2020

Business Legal Updates - Collegiate Student Athletes Can Now Receive Compensation - With the passing of Section 1006.74, F.S., effective July 1, 2020, intercollegiate athletes at a “postsecondary educational institution”…more

Assisted Living Facilities (ALFs), Fiduciary Duty, FinTech, Florida, Foreign Corporations

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Catching Judge Sontchi’s “Flurry of Opinions” PARTS 2-3 OF 3

In This Issue: - In re: Energy Future Holdings Corp., et al, 14-10979 (CSS) (CSC Trust Company of Delaware, as Indenture Trustee, v. Energy Future Intermediate Holdings Company LLC and EFIH Finance, Inc., Adv. Pro No:…more

Chapter 11, Commercial Bankruptcy, Debt, Debtors, Indenture Trustee

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Minimizing the Risk of Litigation: Acquisitions

In an acquisition, part of a buyer’s goal is to make as informed a decision as possible and to close the deal efficiently and inexpensively. Costly, post-acquisition litigation is the last thing any party to a transaction wants…more

Acquisition Agreements, Business Litigation, Contract Terms, Due Diligence, Purchase Agreement

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Ninth Circuit Reverses Landmark Wit Case Addressing Behavioral Health Coverage

The President and his administration continue to tout their efforts to strengthen coverage for behavioral health care, including significantly increasing behavioral health spending and strengthening parity between physical and…more

Biden Administration, Denial of Insurance Coverage, Employee Retirement Income Security Act (ERISA), Health Insurance, Health Plan Sponsors

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Stop, Think, and Be Careful What You Ask For: Lessons and Opportunities Created by Recent Arbitration Ruling

On April 21, 2015, the Missouri Court of Appeals in City of Chesterfield v. Frederich Construction Inc. upheld an arbitration award that included substantial attorneys' fees to the prevailing party, in a construction case where…more

American Arbitration Association, American Rule, Appeals, Attorney's Fees, Construction Contracts

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FDA Finalizes Rule Regulating Laboratory Developed Tests

FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of these…more

Clinical Laboratories, Final Rules, Food and Drug Administration (FDA), Healthcare, Laboratory Developed Tests

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The European Union Has Assigned Your AI Some Homework

Seeking to build on the success and influence of GDPR, the European Union has spent the last seven years constructing a comprehensive regulatory scheme for artificial intelligence: The Artificial Intelligence Act (AI Act)…more

AI Act, Artificial Intelligence, Automation Systems, Cybersecurity, Innovative Technology

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IRS Releases Interim Guidance for Exempt Organizations on New Unrelated Business Income Tax Rules

The IRS and Treasury Department recently released new guidance for calculating the tax on unrelated business income (“UBI”) activities of tax-exempt organizations with more than one UBI activity. With the passage of the 2017 Tax…more

Income Taxes, Interim Guidance, IRS, Tax Cuts and Jobs Act, Tax Exempt Entities

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Texas Offers State Low-Income Housing Tax Credits

Texas Governor Greg Abbott (R) recently signed Texas House Bill (H.B.) 1058, making Texas at least the 28th state, plus the District of Columbia, to offer state low-income housing tax credits to bridge the growing affordable…more

Affordable Housing, Community Development, Construction Project, Critical Infrastructure Sectors, LIHTC

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Recent Federal Circuit Decisions Provide Mixed Messages on Patent Eligible Subject Matter

The Supreme Court’s Alice decision is now more than three years old, however, stakeholders, the courts and the U.S. Patent and Trademark Office are still struggling to understand Alice and, in particular, how to determine…more

CLS Bank v Alice Corp, Intellectual Property Litigation, Patent Infringement, Patent Invalidity, Patent Litigation

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Celsius Bankruptcy Case: February 2, 2023

As Celsius Network LLC, et al., Case Number: 22-10964 (MG), proceeds in the Bankruptcy Court for the Southern District of New York (the “Court”), the highly anticipated examiner report was released on January 31st…more

Bankruptcy Court, Chapter 11, Commercial Bankruptcy, Creditors, Examiners

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Illinois Supreme Court Allows Remote Jury Selection

The Illinois Supreme recently entered an Order allowing for immediate remote jury selection in an attempt to alleviate the COVID-19 pandemic’s enormous impact on the court system. See In re: Illinois Courts Response to COVID-19…more

Coronavirus/COVID-19, Infectious Diseases, Judicial Proceedings, Jury Selection, Jury Trial

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Delaware Court of Chancery Extends Business Judgment Deference to Controller-Driven Stock Reclassification Transaction

Recent Delaware court decisions have underscored the value of procedural safeguards in controlling stockholder transactions—which, at least when involving minority freeze-outs, historically were subject to entire fairness…more

Business Judgment Rule, Controlling Stockholders, Freeze-Out Mergers, Reclassification Rules, Stocks

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New This Month: MO Supreme Court Limits the Construction Industry's Use of Certain Sales and Use Tax Exemptions

On January 13, 2015, the Missouri Supreme Court issued three decisions on sales and use tax that have limited the construction industry's ability to utilize certain exemptions in those areas. Companies that utilize such…more

Construction Industry, Contractors, General Contractors, Sales & Use Tax, Subcontractors

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Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

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President Trump Bans Entry of Certain Temporary Foreign Workers, Extends “Green Card” Ban Through 2020

President Trump has issued a new Executive Order extending the current ban on immigrant visas for those outside the United States, as well as barring entry of new classes of nonimmigrant visas, namely H-1B, H-2B, L, and J visas…more

Coronavirus/COVID-19, Foreign Workers, Green Cards, H-1B, H-2B

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Becoming the Target of an Antitrust Lawsuit: Essential Considerations

Becoming the target of an antitrust lawsuit is a daunting prospect for any business. Antitrust lawsuits are often time-consuming and expensive to defend, and the consequences of losing a case can be severe. Under the Sherman Act…more

Antitrust Investigations, Antitrust Litigation, Antitrust Provisions, Case Consolidation, Competition

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Securities and Exchange Commission Modernizes Disclosure Requirements For Financial Institutions

On September 11, 2020, the Securities and Exchange Commission (the “SEC”) adopted final rules applicable to banks, bank holding companies, savings and loan associations and savings and loan holding companies that will, among…more

Corporate Governance, Disclosure Requirements, Financial Institutions, Financial Statements, GAAP

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A Scalpel, Not a Chainsaw: Supreme Court Drastically Limits the Telephone Consumer Protection Act’s Reach

In December, we reported on the oral argument in the U.S. Supreme Court in Facebook v. Duguid, which presented the question of what was required for equipment to qualify as an automatic telephone dialing system (“ATDS”) under…more

ATDS, Auto-Dialed Calls, Class Action, Facebook, Facebook Inc v Duguid

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Physician not a Hospital “Employee” for Purpose of Title VII Action

On May 8, 2019, the U.S. Seventh Circuit Court of Appeals reaffirmed its test to determine whether a worker qualifies as an “employee” as defined by and subject to Title VII protections. …more

Civil Rights Act, Employee Definition, Employer Liability Issues, Employment Litigation, Healthcare Facilities

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DOJ vs. OIG: Analysis of Recently Issued Federal Compliance Documents

Within just weeks of each other, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued separate documents that health care organizations may use to…more

Compliance Management Systems, Corporate Governance, Department of Health and Human Services (HHS), Department of Justice (DOJ), Health Care Providers

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Financial Wellness Initiatives - Student Loan Debt Returns to Center Stage: Practical Considerations for Adding a Match for Student Loan Payments

The burden of student loan debt is an ever-present challenge for our former post-high school students.   As you probably know, President Biden had proposed a student debt forgiveness plan that was projected to relieve as much as…more

Consumer Financial Products, Debt Relief, Employee Benefits, Employee Contributions, Employer Contributions

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Employee Retention Tax Credits Update: IRS Warns Taxpayers to Beware

On October 19, 2022, the Internal Revenue Service (“Service”) issued news release IR-2022-183, which was intended to warn employers using third-party promoters of Employee Retention Tax Credits (“ERTCs”).  ERTCs were created by…more

CARES Act, Coronavirus/COVID-19, Corporate Counsel, Employee Retention, Internal Revenue Code (IRC)

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Department of Labor Proposes Rule to Increase Overtime Protections

On August 30, 2023, the U.S. Department of Labor (DOL) introduced a proposed rule that would increase the minimum salary required for an employee to be exempt under any of the so-called “White Collar Exemptions” from overtime…more

Department of Labor (DOL), Exempt-Employees, Fair Labor Standards Act (FLSA), Federal Labor Laws, Minimum Salary

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The NLRB Throws A Flag On The Northwestern Football Program

In a much awaited decision, the Regional Director for Region 13 of the National Labor Relations Board ("NLRB") has determined that grant-in-aid scholarship recipients on the Northwestern University football team are more than…more

College Athletes, NLRB, Unions

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‘Alkutkar v. Bumble’: Securing Active Consent for Updated Terms of Service

Overview - The District Court for the Northern District of California recently provided guidance in Alkutkar v. Bumble Inc., No. 22-CV-00422- PJH (N.D. Cal. Sept. 8, 2022), reconsideration denied, No. 22-CV-00422-PJH, (N.D…more

Advertising, Arbitration, Arbitration Agreements, B2B Transactions, Browsewrap Agreement

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Med-Staff Newsletter - August 2022 | VOL 10

Whether you are new to medical staff leadership or have served in the past and have been called to serve again, there are times when you will need to consult a lawyer who specializes in medical staff matters. While there is…more

Abortion, ADEA, Coronavirus/COVID-19, Dobbs v. Jackson Women’s Health Organization, Employer Liability Issues

See all updates »

The Devil's Dictionary of Bankruptcy Terms: Fraudulent Transfer

Fraudulent Transfer: A transfer by the debtor (including the incurring of an obligation by the debtor) voidable under Section 548 or under state law imported into the bankruptcy case through Section 544…more

Bankruptcy Code, Commercial Bankruptcy, Fraudulent Transfers, UFTA

See all updates »

FTC Adopts Data Breach Notification Obligations for Non-Banking Financial Institutions

On October 27, 2023, the Federal Trade Commission (“FTC”) adopted an amendment to the FTC’s Safeguards Rule that will require non-banking financial institutions to notify the FTC within thirty days of discovering a data breach…more

Cyber Attacks, Cyber Incident Reporting, Cybersecurity, Data Breach, Data Protection

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New 340B Dispute Resolution Process: Will It Level the Playing Field?

On August 12, HRSA published a formal proposed rule regarding a 340B Drug Pricing Program administrative dispute resolution (ADR) process. HRSA’s use of the administrative rulemaking process is a rare occasion given its…more

Arbitration, Comment Period, Covered Entities, Dispute Resolution, Drug Pricing

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The Dog Ate My Evidence: Document Destruction Policies And The Duty To Preserve

In This Issue: - The Duty to Preserve ..What triggers the duty to preserve? ..Who has a duty to preserve? ..What is the scope of the duty to preserve? - Litigation Hold Notices - Potential Sanctions…more

Adverse Inference Instructions, Corporate Counsel, Document Retention Policies, Duty to Preserve, Evidence

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Colorado Supreme Court Vindicates the Colorado Oil and Gas Commission: Recent Ruling In Favor of the Oil and Gas Industry

In an important victory for Colorado’s oil and gas industry, the Colorado Supreme Court unanimously supported the decision of the Colorado Oil and Gas Conservation Commission (the “Commission”) to decline a rulemaking sought by…more

Climate Change, CO Supreme Court, Environmental Claims, Mineral Extraction, Oil & Gas

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Maryland Joins Trend Requiring Salary and Wage Disclosures in Job Listings

Effective October 1, 2024, Maryland will become the sixth state (plus the District of Columbia), to require that employers provide an upfront disclosure of the wage or salary range for open positions in job listings. The new law…more

Disclosure Requirements, Employer Liability Issues, Hiring & Firing, Job Ads, Job Applicants

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IRS Attacks Impact Investing With Flawed Logic: A Critical Review of the IRS Argument

On October 9th, the Internal Revenue Service released Private Letter Ruling 202041009 (the “Ruling”), which, in what many in the nonprofit community would have expected to be a relatively straight-forward exemption approval for…more

501(c)(3), Charitable Organizations, Investment, Investment Funds, IRS

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Florida Legal Update: Laws of Interest Effective July 1, 2020

Business Legal Updates - Collegiate Student Athletes Can Now Receive Compensation - With the passing of Section 1006.74, F.S., effective July 1, 2020, intercollegiate athletes at a “postsecondary educational institution”…more

Assisted Living Facilities (ALFs), Fiduciary Duty, FinTech, Florida, Foreign Corporations

See all updates »

Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

See all updates »

HHS OCR Issues New, Post-Dobbs Guidance

In the wake of the Dobbs decision, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued new guidance regarding the privacy of patients seeking reproductive health care. The guidance…more

Abortion, Department of Health and Human Services (HHS), Dobbs v. Jackson Women’s Health Organization, Equal Protection, Health Insurance Portability and Accountability Act (HIPAA)

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What Did I Agree To? Importance of Reviewing Arbitration Provisions

Polsinelli recently defeated a motion to dismiss a client’s judicial review of an arbitration award, successfully arguing that adopted arbitration rules that waive appellate rights do not waive a party’s right to judicial review…more

Arbitration, Arbitration Agreements, Arbitration Awards, Business Litigation, Commercial Court

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Critical Infrastructure Cybersecurity – Evolving Incident Response Obligations, Integral to Effective Risk Management

Just over a year ago, the White House issued its long-awaited National Cybersecurity Strategy, with an emphasis on defending Critical Infrastructure, promoting public and private collaboration, and safeguarding…more

Critical Infrastructure Sectors, Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA), Cyber Threats, Cybersecurity, Data Protection

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St. Luke's Health: Does Improving Patient Care Justify a Merger Under Antitrust Law? Ninth Circuit Says "No" and Orders Divestiture

Healthcare providers frequently consolidate to cut costs and improve patient care. These benefits can result from sharing administrative costs such as billing and electronic recordkeeping, eliminating excess capacity, better…more

Antitrust Provisions, Divestiture, Federal Trade Commission (FTC), Hospital Mergers, Hospitals

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The Dog Ate My Evidence: Document Destruction Policies And The Duty To Preserve

In This Issue: - The Duty to Preserve ..What triggers the duty to preserve? ..Who has a duty to preserve? ..What is the scope of the duty to preserve? - Litigation Hold Notices - Potential Sanctions…more

Adverse Inference Instructions, Corporate Counsel, Document Retention Policies, Duty to Preserve, Evidence

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Mitigating Your Greatest Data Privacy Risk

Third-party vendors pose a significant risk - The greatest data privacy threat to companies is commonly thought to be that company’s employees. While employees can be a threat, the majority of data breaches and intrusions…more

Data Breach, Data Privacy, Data Protection, Information Security, Information Technology

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SEC Proposes Changes to Modernize and Simplify Equity Compensation Rules and Registration Obligations

On November 24, 2020, the Securities and Exchange Commission (“SEC”) proposed amendments to Rule 701 and Form S-8 (the “Proposals”) under the Securities Act of 1933, as amended (the “Securities Act”)…more

Disclosure Requirements, Form S-8, Publicly-Traded Companies, Rule 701, Securities and Exchange Commission (SEC)

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Making Sense of the MACRA Final Rule, Part 2 of 3: Alternative payment Models

Many observers view the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) as a game changer for the delivery and payment of health care services. On Oct. 14, 2016 the Centers for Medicare & Medicaid Services…more

ACOs, Alternative Payment Models (APM), CEHRT, Centers for Medicare & Medicaid Services (CMS), Electronic Health Record Incentives

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The Applicability of Anti-Fraud Rules to Certain Statements and Information made by Obligated Persons of Municipal Securities – A Legal Bulletin ‘Reminder’ from the Office of Municipal Securities

On February 7, 2020, the Securities and Exchange Commission’s (the “SEC”) Office of Municipal Securities released its Legal Bulletin No. 21 (the “Bulletin”) regarding the applicability of the anti-fraud provisions of the federal…more

Anti-Fraud Provisions, Disclosure Requirements, Investment Opportunities, Municipal Securities Issuers, Municipal Securities Market

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Easement Fund Victory on Perpetuity Will Result in More Attention on Valuation

In the latest victory for taxpayers, the Tax Court determined that the Treasury failed to follow federal law in enacting a conservation easement perpetuity rule known as the “proceeds regulation.” The majority opinion held that…more

Charitable Donations, Conservation Easements, Internal Revenue Code (IRC), IRS, Property Owners

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Health Reform + Related Health Policy News - December 2014, Issue 1

In This Issue: - Top News ..Congress Passes Omnibus Spending Package ..HRSA Cancels Plan for 340B ‘Mega Reg’; Congress Weighs Options ..Supreme Court to Hear Challenge to ACA Subsidies -…more

Affordable Care Act, Appropriations Bill, Centers for Medicare & Medicaid Services (CMS), Halbig v Burwell, Healthcare

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CMS Encourages Continued Participation in Medicare Shared Savings Program with Final Rule

In This Issue: - ACO Eligibility Requirements - Establishing and Maintaining the ACO Participation Agreement - Data Sharing and Assignment of Beneficiaries - Shared Savings and Losses - Waivers of…more

ACO Participant Agreements, ACOs, Centers for Medicare & Medicaid Services (CMS), Data-Sharing, Electronic Health Record Incentives

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Medicare Continues its Updates to Provider Enrollment Policies as Part of Efforts to Enhance Program Integrity and Transparency

The Centers for Medicare & Medicaid Services (“CMS”) continued its efforts to increase oversight of the Medicare program by updating Medicare provider enrollment regulations and policies through recent regulatory and…more

Centers for Medicare & Medicaid Services (CMS), Enrollment, Health Care Providers, Health Insurance, Healthcare

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ESOP Defendant Wins Partial Victory in Appeal to Fourth Circuit

The Fourth Circuit Court of Appeals has provided relief to a defendant who sold shares of company stock to an employee stock ownership plan (“ESOP”) by rejecting the district court’s legal conclusion concerning the calculation…more

Department of Labor (DOL), Employee Benefits, ESOP, Fair Market Value, Prohibited Transactions

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COVID-19 and Its Growing Impact on Commercial Contracts: How Should Contracting Parties Respond?

COVID-19 is causing a rapidly evolving public health crisis, and businesses face uncertainty about their commercial relationships. That uncertainty is raising questions about performance under contractual agreements that were…more

Business Interruption, China, Commercial General Liability Policies, Commercial Insurance Policies, Commercial Loans

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ESOP Defendant Wins Partial Victory in Appeal to Fourth Circuit

The Fourth Circuit Court of Appeals has provided relief to a defendant who sold shares of company stock to an employee stock ownership plan (“ESOP”) by rejecting the district court’s legal conclusion concerning the calculation…more

Department of Labor (DOL), Employee Benefits, ESOP, Fair Market Value, Prohibited Transactions

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Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

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Reminder: Upcoming Filing Deadlines for Fund Managers

With the new year comes a number of annual compliance obligations for evaluation by investment fund managers. In addition to the obligation for registered investment advisers to conduct an annual review of their compliance…more

Beneficial Owner, Filing Deadlines, Fund Managers, Hedge Funds, Investment Funds

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Five Fast Facts about Washington’s New Noncompetition Law

On May 8, 2019, Washington Governor Jay Inslee signed into law a bill that prohibits employers from entering into noncompetition covenants with employees whose W-2 earnings are less than $100,000, and with independent…more

Employer Liability Issues, Employment Contract, Hiring & Firing, New Legislation, Non-Compete Agreements

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Texas Offers State Low-Income Housing Tax Credits

Texas Governor Greg Abbott (R) recently signed Texas House Bill (H.B.) 1058, making Texas at least the 28th state, plus the District of Columbia, to offer state low-income housing tax credits to bridge the growing affordable…more

Affordable Housing, Community Development, Construction Project, Critical Infrastructure Sectors, LIHTC

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Good News on the Horizon? FCA Reform Could Signal Relief for Health Care Providers

Good news may be in sight for businesses and health care providers. On April 28, 2016, the House Judiciary Committee's Subcommittee on the Constitution and Civil Justice once again considered potential updates to the…more

False Claims Act (FCA), Health Care Providers, Healthcare Fraud, Legislative Committees, Qui Tam

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Court Provides Additional Guidance On When Notes Are Not Securities - The Kirschner Case

The loan market breathed an immense sigh of relief this spring with the ruling in Kirschner v. JPMorgan Chase Bank, N.A. 1 (“Kirschner”) affirming the prevailing market view that notes representing syndicated loans are not…more

Contract Terms, Investment Management, JPMorgan Chase, Leveraged Loans, Securities Regulation

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Optum Seeks Massive Clawback of Medicare Advantage Plan Payments

Recently, Optum Behavioral Health (“Optum,” the services division for UnitedHealth Group) has initiated overpayment recovery actions against numerous licensed clinical social workers (“LCSWs”) across the country for services…more

Centers for Medicare & Medicaid Services (CMS), Clawbacks, Health Care Providers, Medicare Advantage, Overpayment

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Texas Supreme Court Confirms Texas Home-Equity Lenders Are Entitled to Equitable Subrogation Irrespective of Failures to Correct Curable Constitutional Defects in Loan Documents

Last week, the Texas Supreme Court issued a significant decision in favor of Texas home-equity lenders in Federal Home Loan Mortgage Corporation v Zepeda, No. 19-0712, answering “yes” to the following certified question from the…more

Home Equity, Home Equity Line of Credit, Lenders, Loan Documentation, Mortgages

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IRS Attacks Impact Investing With Flawed Logic: A Critical Review of the IRS Argument

On October 9th, the Internal Revenue Service released Private Letter Ruling 202041009 (the “Ruling”), which, in what many in the nonprofit community would have expected to be a relatively straight-forward exemption approval for…more

501(c)(3), Charitable Organizations, Investment, Investment Funds, IRS

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Private Biometric Data: Union Consent to Collection

On June 13, 2019, the U.S. Seventh Circuit Court of Appeals in Miller v. Southwest Airlines, Co., Case 18-3476 (June 13, 2019), ruled that claims asserted under the Illinois Biometric Information Privacy Act (“BIPA”), in the…more

Appeals, Biometric Information, Biometric Information Privacy Act, Case Consolidation, Data Collection

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Analyzing the Proposed 2019 Stark Reforms

The United Stated Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking (NPRM) containing proposed changes to the Physician Self-Referral Law (“Stark Law,” or “Stark”) on October 17, 2019…more

Anti-Kickback Statute, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Health Care Providers, Healthcare Reform

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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Loan Enforcement and Creditors’ Rights

At times, lenders lose the promissory notes on defaulted loans. Lost notes are problematic because, in order to have standing to foreclose, a lender may be required in many states, including in New York, to possess the original…more

Banking Sector, Commercial Loans, Default, ECOA, Foreclosure

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HRSA Aims for Swift Dispute Resolution with new 340B ADR Final Rule

On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers…more

Claim Procedures, Covered Entities, Dispute Resolution, Drug Pricing, Healthcare

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Fantasy Sports Sites Win Challenge to Publicity Rights in Indiana

Recently, the Seventh Circuit affirmed that fantasy sports operators, such as FanDuel and Draft Kings, do not violate a student athlete’s right of publicity under Indiana law by using their name, image and likeness without their…more

DraftKings, FanDuel, Fantasy Sports, Gambling, Name and Likeness

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FERC Proposes Changes to PURPA Regulations

On September 19, 2019, the Federal Energy Regulatory Commission (FERC) issued a Notice of Proposed Rulemaking (NOPR) that outlines potentially significant changes to FERC’s regulations implementing the Public Utility Regulatory…more

Comment Period, FERC, Notice of Proposed Rulemaking (NOPR), PURPA, Qualifying Facility

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QFC Rule and Resolution Stay Protocol

Clients who have engaged in Qualified Financial Contracts (QFCs)—which include derivatives, repurchase agreements and securities lending—with large financial institutions may have received, or may soon receive, a notice…more

Consumer Financial Products, Derivatives, Financial Institutions, ISDA, Qualified Financial Contracts (QFC)

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FDA Preemption of State Law for False Labeling Survives Appeal to Supreme Court

Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision…more

Denial of Certiorari, Dietary Supplements, False Advertising, Federal Food Drug and Cosmetic Act (FFDCA), Food & Drug Regulations

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Meat Processing: COVID Liabilities

In the midst of the pandemic, meat processing facilities have struggled to meet demand while protecting employees. Governmental regulations, orders and guidelines often have seemed to be inconsistent with one another. Even…more

Centers for Disease Control and Prevention (CDC), Coronavirus/COVID-19, Defense Production Act, Farm Animals, Food Manufacturers

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Divided Illinois Supreme Court Holds that BIPA Claims Accrue with Each Scan, Potentially Opening the Door to Massive Damages Awards

In a recent 4-3 decision, the Illinois Supreme Court held that claims under sections 15(b) and 15(d) of Illinois’ Biometric Information Privacy Act (BIPA) accrue each time a private entity collects a biometric identifier (such…more

Accrual Requirements, Biometric Information, Biometric Information Privacy Act, Damages, Data Collection

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New York to Consider Rolling Back Liquidated Damages for Pay Frequency Violations

New York Governor Kathy Hochul’s proposed budget for fiscal year 2025 includes proposed legislation that would amend New York Labor Law to make clear that liquidated damages are not available as a remedy for certain pay…more

Employer Liability Issues, Employment Litigation, Labor Law Violations, Labor Reform, Liquidated Damages

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Proposed Rule to Strengthen State Medicaid Fraud Control Units

A recently published proposed rule expands the functions and responsibilities of state Medicaid Fraud Control Units (MFCUs). The rule was issued by the Centers for Medicare and Medicaid Services (CMS) and the Office of…more

Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), Comment Period, Data Mining, False Claims Act (FCA)

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The MOAC Decision: Implications for DIP Lenders, Not Just for Asset Purchasers

The Supreme Court’s April 19, 2023, decision in MOAC Mall Holdings, LLC v. Transform Holdco, LLC, 598 U.S.­­­___, ___S. Ct.___, 2023 WL 2992693 (April 19, 2023) resolved an existing circuit split by holding that section 363(m)…more

363 Sales, Bankruptcy Code, Bankruptcy Court, Chapter 11, Commercial Bankruptcy

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Prop 15 is Ready to Rock Commercial Properties with the Split-Roll

On November 3, 2020, California voters will decide on Proposition 15, the citizen-initiated proposition that seeks to create a split-roll tax system in California. Also known as “The California Schools and Local Communities…more

Ballot Measures, Property Owners, Property Tax, Property Valuation, Real Estate Market

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U.S. Supreme Court Rejects Asbestos Defendants “Bare Metal Defense” in Maritime Cases

In Air & Liquid Sys. Corp. et al. v. DeVries et al., No. 17-1104 (March 19, 2019), the U.S. Supreme Court held that under federal maritime law, a product manufacturer has a duty to warn when its product requires the…more

Actual or Constructive Knowledge, Air and Liquid Systems Corp et al v Devries et al, Appeals, Asbestos, Asbestos Litigation

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New Texas Law Aims to Curb Local Prosecutorial Discretion

A new Texas law will go into effect on September 1, 2023 that is directly aimed at curbing the discretion of local prosecutors in deciding which classes or types of cases they choose not to pursue…more

Attorney Misconduct, Criminal Prosecution, District Attorneys, Healthcare, New Legislation

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New Clinical Trial Rule Alters Reporting Requirements

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health and…more

Clinical Trials, Department of Health and Human Services (HHS), Final Rules, Food and Drug Administration (FDA), Healthcare

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SEC Cybersecurity Guidance: Key Takeaways for Your Business

The U.S. Securities and Exchange Commission (“SEC”) recently released interpretive guidance regarding issues and risks related to cybersecurity for the first time since 2011…more

Cybersecurity, Disclosure Requirements, Insider Trading, Investment Adviser, Securities and Exchange Commission (SEC)

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AI is Fueling a Major Contract Dispute in the Music Industry: Why it Matters for Your Business

Whether or not you are a TikTok user, you have likely heard about how the platform allows creators to combine music clips with original content to create viral videos. The ability for users to leverage an extensive music…more

Artificial Intelligence, Contract Disputes, Corporate Counsel, Intellectual Property Protection, Mobile Apps

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How the Federal Tort Claims Act Extricates Certain Health Care Providers From Data Breach Class Action Suits

Data breach class action litigation continues to occupy center stage in the ongoing struggle to secure compensation and redress for legitimate victims of actionable cybersecurity shortcomings of data owners. The underlying…more

Class Action, Cybersecurity, Data Breach, Health Care Providers, Healthcare

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Member of an Arizona LLC? You May Have a Fiduciary Duty to the LLC

Arizona has finally resolved the issue of whether managers and members of an Arizona Limited Liability Company (LLC) owe a common law fiduciary duty to the LLC and whether an operating agreement can lawfully limit those…more

AZ Supreme Court, Business Litigation, Common Law Torts, Contract Terms, Duty of Care

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Health Reform + Related Health Policy News Update - April 2013

In this Issue: - Top News ..Large Hospital Systems Settles for $25.5 Million for False Claims Act Allegations ..Catholics’ Challenge to Contraceptive Coverage Mandate Dismissed As Not Ripe - States…more

Centers for Medicare & Medicaid Services (CMS), Contraceptive Coverage Mandate, False Claims Act (FCA), Healthcare, Hospitals

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Estate Planning Impact Of The Secure Act

The ‘Setting Every Community Up for Retirement Enhancement’ Act (the “SECURE Act”) was signed into law on December 20, 2019 and became effective January 1, 2020…more

401k, 403(b) Plans, Beneficiary Designations, Compensation & Benefits, Employee Benefits

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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Delaware Supreme Court: No General Jurisdiction Over Non-Delaware Businesses Simply by Virtue of Registering to Do Business in Delaware

Merely registering to do business in Delaware does not subject a non-Delaware company to the general jurisdiction of Delaware courts. In Genuine Parts Company v. Cepec, Delaware Supreme Court Chief Justice Leo E. Strine,…more

Corporate Counsel, DaimlerChrysler v Bauman, Delaware General Corporation Law, Due Process, Foreign Corporations

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Polsinelli Obtains Favorable Decision in Challenge to Colorado’s Medicaid Funding Program

Medicaid is a shared federal and state program. Federal and state dollars are combined so states can furnish Medicaid health coverage to poor and disabled Coloradans including many who need nursing facility care…more

Constitutional Challenges, Federal Funding, Health Insurance, Medicaid, State and Local Government

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Concerns and Considerations for Using Generative Artificial Intelligence as Part of Routine Business Operations

As artificial intelligence and machine learning (collectively “AI”) models continue to develop, become more sophisticated, and generate significant media coverage, companies are increasingly considering the integration of AI…more

Artificial Intelligence, Bias, Business Operations, Copyright Infringement, Innovative Technology

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Subscription Service Businesses Take Notice: Amendments to California’s Automatic Renewal Law Are Here

Subscription service providers should be aware of the various changes coming to California's automatic renewal law. California’s already stringent laws governing recurring subscription programs are about to become even more…more

Amended Legislation, Automatic Renewals, California, Cancellation Rights, Commercial Litigation

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California Bill Would Require Hospitals, Clinics and Other Health Facilities to Report Allegations of Patient Sexual Abuse to State Regulators

California Senate Bill 425, introduced in February 2019, would require health facilities and clinics to report any allegations of sexual abuse or sexual misconduct made against a clinician within 15 days of receiving the…more

Health Care Providers, Health Clinics, Healthcare Facilities, Internal Controls, Legislative Agendas

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IRS Says: New Goal is to Restore Fairness by Using Tax Dollars to Audit More Millionaires, Partnerships and Large Corporations

Following our initial reaction to the Internal Revenue Service's strategic operating plan to spend $80B in funding allocated from the Inflation Reduction Act, Polsinelli’s Tax attorneys continue to monitor the IRS’ compliance…more

Artificial Intelligence, High Net-Worth, Income Taxes, Inflation Reduction Act (IRA), Internal Revenue Code (IRC)

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Just What the Doctor Ordered: Employer Guidance for Responding To Coronavirus Outbreak

The recent outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, has left many employers across the country grappling with how to effectively and lawfully protect…more

Best Practices, Business Continuity Plans, China, Coronavirus/COVID-19, Emergency Management Plans

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Polsinelli Podcast - Selling Your Business

When planning for the sale of a business, business owners may not recognize the value of a business’ intangible assets. Or, they may not be familiar with the process of transferring or selling those assets. For certain types of…more

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ACA "Pay Or Play" Deadline Extension — What It REALLY Means

On July 2, 2013, the U.S. Treasury announced that the Obama Administration is implementing a one-year delay of the employer and insurer reporting requirements under the Affordable Care Act of 2010 ("ACA")…more

Affordable Care Act, Deadlines, Delays, Employer Group Health Plans, Employer Mandates

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COVID-19 Surge and Travel Restrictions and Advisories are Upending Thanksgiving Plans Across the Country

With more than 1 million cases reported in the United States over the last 7 days and cases rising, the U.S. Centers for Disease Control and Prevention (“CDC”) issued guidance on November 19, 2020 recommending Americans not…more

Centers for Disease Control and Prevention (CDC), Coronavirus/COVID-19, Emergency Management Plans, Infectious Diseases, International Travel

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SEC Updates and Simplifies Certain Disclosure Requirements

On August 17, 2018, the U.S. Securities and Exchange Commission (SEC) amended its rules to modernize and streamline certain disclosure requirements for public companies and those pursuing an IPO…more

Disclosure Requirements, Financial Regulatory Reform, GAAP, Initial Public Offering (IPO), Publicly-Traded Companies

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Hydrocarbon Tax Policy Trends

As governments focus on clean energy and carbon reduction initiatives, their oil and gas taxation policies have increasingly come under scrutiny. Polsinelli’s attorneys review a few overarching themes concerning expected trends…more

Carbon Pricing, Energy Policy, Gas Royalties, Hydrocarbons, Infrastructure

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Two Major Implications for Consumer Finance Industry from This Month’s Proposed CFPB Rules

When the Consumer Finance Protection Bureau (CFPB) released its study on the use of pre-dispute arbitration (PDA) clauses earlier this year, many expected the CFPB to propose a ban on all PDAs in contracts for consumer finance…more

Arbitration Agreements, Automotive Loans, Bank Accounts, Class Action, Compliance

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IRS Clarifies Requirements for Listing Providers in Financial Assistance Policies

On June 26, 2015, the Internal Revenue Service (IRS) released Notice 2015-46, which clarifies the requirement in the Treasury Regulations under Section 501(r)(4) that a hospital's financial assistance policy (FAP) must include a…more

Affordable Care Act, Compliance, Financial Assistance Policies, Health Care Providers, Healthcare

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Taking Care of Essential Business Despite Growing Number of Shelter in Place Orders — COVID-19

A growing number of states, six as of the publication date of this e-alert, along with the Puerto Rico, the Navajo Nation and a significant number of counties and municipalities, have issued mandatory “shelter in place” or “stay…more

Business Closures, Business Continuity Plans, Business Interruption, Coronavirus/COVID-19, Emergency Management Plans

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SCOTUS Appears Poised To Reject Defense-Friendly Safeco Scienter Standard In FCA Cases

On April 18, 2023, the Supreme Court of the United States (SCOTUS) heard oral arguments in a pair of monumental False Claims Act (FCA) cases to decide whether and when a defendant’s subjective understanding of an objectively…more

Drug Pricing, False Claims Act (FCA), Fraud, Healthcare, Oral Argument

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The Medicare Physician Fee Schedule for 2019

On November 1, 2018, the Centers for Medicare & Medicaid Services (“CMS”) released an advanced copy of the final rule announcing policies and payment levels for the Medicare Physician Fee Schedule for 2019, implementing policy…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Medicare, Medicare Part B, Physician Fee Schedule

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Proposed Regulations on Disguised Payments for Services and Management Fee Waivers

On July 23, 2015, the Internal Revenue Service (“IRS”) issued a Notice of Proposed Rulemaking (the “Notice”) which proposed Treasury regulations under Section 707(a)(2)(A) of the Internal Revenue Code of 1986, as amended (the…more

Allocation of Funds, Clawbacks, Entrepreneurs, Fee Waivers, Internal Revenue Code (IRC)

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POTUS Changes WOTUS (“Waters of the United States”)

On December 28, 2018, the EPA published in the Federal Register a revised definition of “waters of the United States” (the “Proposed Rule”), as used in the Clean Water Act, to replace the current definition that was finalized in…more

Clean Water Act, Environmental Policies, Environmental Protection Agency (EPA), Jurisdictional Determination (JD), Navigable Waters

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Mastering Remote Work: Does Returning to the Office Mean Bringing Pets to Work?

With so much of the workforce going remote this past year, there has been a huge shift in the way many people view pet ownership. In fact, the national pet adoption rate jumped more than 30% at the beginning of the pandemic, and…more

Americans with Disabilities Act (ADA), Anti-Discrimination Policies, Business Continuity Plans, Coronavirus/COVID-19, Employment Policies

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Easement Fund Victory on Perpetuity Will Result in More Attention on Valuation

In the latest victory for taxpayers, the Tax Court determined that the Treasury failed to follow federal law in enacting a conservation easement perpetuity rule known as the “proceeds regulation.” The majority opinion held that…more

Charitable Donations, Conservation Easements, Internal Revenue Code (IRC), IRS, Property Owners

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New Tax Program Incentivizes Long-Term Investment in Distressed Areas

As part of the major tax reform bill passed in December, the Tax Cuts and Jobs Act of 2017, Congress created a new program to promote long-term investments in low-income areas by providing the opportunity for taxpayers to…more

Community Development, Economic Development, Investment Funds, Low Income Housing, Low-Income Issues

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Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787…more

Abbreviated New Drug Application (ANDA), America Invents Act, Generic Drugs, Hatch-Waxman, Intellectual Property Protection

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NLRB Overrules 2016 Decision Requiring Employers To Negotiate With Newly Certified Union Over Disciplinary Action

The National Labor Relations Board has overruled a previous Board’s 2016 Decision and reset an employer’s ability to discipline union-represented employees before reaching a first contract with the union…more

Collective Bargaining Agreements (CBA), Disciplinary Proceedings, NLRB, Retroactive Application, Unions

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The Privacy Survival Guide - August 2021

Virginia recently adopted a GDPR-inspired comprehensive data protection law for Virginia residents. What Are the Main Points Covered by Virginia’s Consumer Data Protection Act (CDPA)? …more

21st Century Cures Act, Biometric Information, Biometric Information Privacy Act, CDPA, Consumer Privacy Rights

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Health Care Reimbursement and Payor Dispute Update - September 2021

On July 1, 2021, the Departments of Health and Human Services (“HHS”), Treasury, and Labor, along with the Office of Personnel Management (collectively the “Departments”), issued the first tranche of regulations implementing the…more

Biden Administration, Drug Pricing, Health Care Providers, Health Insurance, Healthcare Reform

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What is the Impact of the FTC’s Final Non-Compete Rule on Franchisors and Franchisees?

As explained in Polsinelli’s prior alert of April 24, 2024, the FTC announced its final rule on non-compete covenants (the “Rule”) on April 23, 2024. Critically, the Rule does not prohibit non-compete agreements between…more

Competition, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC), Franchisee

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Virginia General Assembly Reverses Virginia Supreme Court on Requirement that Leases of more than Five Years be in the form of a Deed

In legislative action that will be welcomed by Virginia landlords and their mortgage lenders, the Virginia General Assembly, in its most recent session, amended the Virginia Statute of Conveyances (Va. Code Ann. § 55-2) to…more

Deeds, General Assembly, Landlords, Leases, Reversal

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Missouri Joins States Legalizing Recreational Marijuana – Cutting Through the Haze on Missouri Amendment 3

This month, businesses in Missouri will be permitted to sell recreational marijuana products. The permitted sales are one of the many changes that came about because of Constitutional Amendment 3, which legalized the…more

Decriminalization of Marijuana, Employees, Employment Policies, Marijuana, New Legislation

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‘Just Give Me Some Space’ — Eleventh Circuit Clarifies “Similarly Situated” Standard

On March 21, 2019, in a 9-3 en banc decision, the U.S. Eleventh Circuit Court of Appeals clarified the “similarly situated” standard for comparator evidence in employment discrimination cases.  Lewis v. City of Union City,…more

Employer Liability Issues, Employment Discrimination, Employment Litigation, Evidence, Similarly Situated

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Supreme Court Reminds Companies to Monitor 401(k) Plan Investments, Sets Parameters for "Regular Review" Requirements

Companies and in-house fiduciaries face increasing scrutiny these days over their 401(k) and other retirement plans. This was underscored again recently by a key Supreme Court ruling. In Tibble v. Edison International, the U.S…more

401k, Benefit Plan Sponsors, Breach of Duty, Department of Labor (DOL), Employee Retirement Income Security Act (ERISA)

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Update on Pending Legislation: Three New Bills Have the Potential to Affect Generic Pharmaceutical Companies

In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. …more

Abbreviated New Drug Application (ANDA), Exclusivity, Generic Drugs, Hatch-Waxman, Intellectual Property Protection

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Polsinelli-TrBK Distress Indices - Third Quarter 2018

We are pleased to announce the release of the Polsinelli-TrBK Distress Indices Report for the third quarter of 2018. Polsinelli, with data provided exclusively by TrollerBk.com, publishes the Indices Report on a quarterly…more

Chapter 11, Commercial Bankruptcy, Distressed Debt, Healthcare, Real Estate Market

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Entities of All Types Should Consider Commenting on the FTC’s Health Breach Notification Rule by August 20, 2020

On May 22, 2020, the Federal Trade Commission (the “FTC”) published its decennial request for public comment (the “RFC”) on the FTC’s Health Breach Notification Rule (the “HBN Rule”)…more

Breach Notification Rule, Comment Period, Cybersecurity, Data Breach, Data Protection

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California Employers Must Know: Meal/Rest Premiums Are ‘Wages’

California reaffirms its reputation as the most employee-friendly state and raises potential liability for employers. On May 23, 2022, the California Supreme Court issued the long-awaited decision in Naranjo v. Spectrum Security…more

CA Supreme Court, Employer Liability Issues, Employment Litigation, Employment Policies, Labor Law Violations

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Easement Fund Victory on Perpetuity Will Result in More Attention on Valuation

In the latest victory for taxpayers, the Tax Court determined that the Treasury failed to follow federal law in enacting a conservation easement perpetuity rule known as the “proceeds regulation.” The majority opinion held that…more

Charitable Donations, Conservation Easements, Internal Revenue Code (IRC), IRS, Property Owners

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DCGL Amendment May Breathe New Life Into Zombie Companies

On August 1, 2023, the Delaware General Corporation Law (DGCL) was amended to create an “insolvency exception” to Delaware’s long-standing requirement that a sale of all or substantially all of a Delaware corporation’s assets…more

Board of Directors, Business Ownership, Corporate Governance, Corporate Restructuring, Delaware General Corporation Law

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Lowering the Bar: The FTC Lowers HSR Premerger Reporting Thresholds for the First Time in a Decade

On February 2, 2021, the FTC published its annual changes to the thresholds for determining whether certain transactions must be reported to FTC and DOJ under the Hart-Scott-Rodino Act before closing can occur…more

Antitrust Provisions, Department of Justice (DOJ), Federal Trade Commission (FTC), Hart-Scott-Rodino Act, Interlocking Directorate

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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Voting in the Celsius Bankruptcy Case

As we have been discussing in prior updates, the bankruptcy case of Celsius Network LLC is reaching an important milestone as most creditors now have the ability to vote on the Plan of Reorganization proposed by the Debtors (the…more

Bankruptcy Court, Commercial Bankruptcy, Creditors, Debt Restructuring, Debtors

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NASAA Shuts Down Use of Acknowledgments and Questionnaires in Franchise Sales Process

The North American Securities Administrators Association, Inc. (“NASAA”) has just adopted a new policy regarding the use of franchise questionnaires and acknowledgments in the franchise sales process. In its Statement of Policy…more

Franchise Disclosure Document, Franchise Laws, Franchisee, Franchises, NASAA

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Missouri Seeks to Limit Venue in Multi-Plaintiff Cases

In State ex rel. Johnson & Johnson v. The Honorable Rex M. Burlison, dozens of plaintiffs sought to bring their claims against Johnson & Johnson in the City of St. Louis, Missouri even though they were not residents of the city…more

Johnson & Johnson, Joinder, Mass Tort Litigation, Multi-Party Litigation, Non-Residents

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Expecting the Unexpected: Federal Procurement Under Trump

Federal contractors (and their lawyers) have spent much of the past two months trying to anticipate how federal procurement law and policy may change under the incoming Trump Administration. The first factor to note, which…more

Boeing, Federal Acquisition Regulations (FAR), Federal Contractors, Lockheed Martin, OFPP

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Disclosures Still Important: Delaware Court of Chancery Assesses Adequacy of Proxy Disclosures in Rejecting Pleading-Stage Application of Corwin Defense

Disclosure-based strike suits have died an inglorious and richly-deserved death in Delaware. Lest deal practitioners and their clients be lulled into a false sense of security, recent decisional law drives home the point (again)…more

Business Judgment Rule, Controlling Stockholders, Corwin Doctrine, Disclosure Requirements, Fiduciary Duty

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The PTAB and the Arthrex Decision: A Constitutional Question

The Appointments Clause of the U.S. Constitution1 provides that “principal officers” of the United States must be appointed by the President upon the advice and consent of the Senate. “Inferior officers,” on the other hand, do…more

Administrative Appointments, Administrative Authority, Administrative Patent Judges, Administrative Procedure Act, Administrative Proceedings

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Health Reform + Related Health Policy News

Enrollment in Health Plans under ACA Exceeds Projected Number of 7 Million - The White House announced on April 1 that 7.1 million Americans had enrolled in health plans under the Affordable Care Act ("ACA")…more

Affordable Care Act, Department of Health and Human Services (HHS), Health Insurance Portability and Accountability Act (HIPAA), Healthcare Reform, Medicare

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Laws and Regulations Affecting Government Contractors

How Trump’s “Buy American and Hire American” Could Alter Procurements - The President’s “Buy American and Hire American” Executive Order (EO), issued April 18, 2017, reflects Executive Branch policy and orders several…more

Affordable Care Act, Buy America, Domestic Hiring Policy, Executive Orders, Federal Contractors

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Lender's Edge Newsletter: December 2016

Enforcement of a Commercial Loan After the Property Securing the Loan is Sold or Transferred - Enforcement of due-on-sale clauses started growing in popularity in the 1970s as a result of instability in the economy and rising…more

Banking Sector, Borrowers, Chapter 11, Commercial Bankruptcy, Commercial Loans

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Filing Fee for .sucks Top-Level Domain Names Really Sucks for Brand Owners

The recent top-level domain name explosion has been of great interest to existing brand owners and new market entrants alike. No longer is a business limited to deciding which of a few top-level domains, such as .com, .net,…more

Domain Names, Filing Fees, gTLD, ICANN, Trademarks

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Health Reform + Related Health Policy News - October 2013 - Issue 3

In This Issue: - Top News ..Deal to Raise Debt Ceiling, End Shutdown Yields No Major Changes to Health Care Law ..Problems with HealthCare.gov Website Continue; HHS Working to Fix Issues ..Kaiser Study…more

Abortion, Affordable Care Act, Debt Ceiling, Department of Health and Human Services (HHS), Fraud

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President Biden Mandates COVID-19 Vaccinations: Stay Tuned…

On September 9, 2021, President Biden unveiled a COVID-19 Action Plan that requires, among other things, millions of private-sector employees, health care workers, federal employees, and employees of federal contractors to be…more

Biden Administration, Coronavirus/COVID-19, Critical Infrastructure Sectors, Emergency Management Plans, Employer Liability Issues

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U.S. Federal Privacy Bill Unveiled

On April 5, 2024 members of U.S. Congress released a draft bipartisan, bicameral federal privacy bill, the American Privacy Rights Act. In a press release, the stated goal of this legislation is to be “a national data privacy…more

Consumer Privacy Rights, Data Brokers, Data Management, Data Privacy, Data Processors

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eBay Lawsuit Dismissed

On May 4, 2015, a US District Court judge in the Eastern District of Louisiana dismissed a class action lawsuit that sought damages from eBay based on the “threat of future harm” stemming from the online retailer’s 2014 data…more

Article III, Clapper v. Amnesty International, Class Action, Cyber Attacks, Cybersecurity

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Estate Planning Impact Of The Secure Act

The ‘Setting Every Community Up for Retirement Enhancement’ Act (the “SECURE Act”) was signed into law on December 20, 2019 and became effective January 1, 2020…more

401k, 403(b) Plans, Beneficiary Designations, Compensation & Benefits, Employee Benefits

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FCC's Decision on Net Neutrality Likely to Lead to Litigation

In a historic 3-2 vote on Thursday, February 26th, the Federal Communications Commission (FCC) voted to approve net neutrality rules aimed at governing Internet traffic. The FCC's decision would expand government oversight for…more

See all updates »

Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

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A Crypto-Tax Indictment Goes Viral

As reported in several recent entries on this blog, IRS has been engaged in ongoing efforts to enforce the taxation of cryptocurrency transactions.. These actions have run the gamut from educating investors,  miners and others…more

Criminal Prosecution, Cryptocurrency, Extradition, Financial Transactions, Indictments

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Filing Fee for .sucks Top-Level Domain Names Really Sucks for Brand Owners

The recent top-level domain name explosion has been of great interest to existing brand owners and new market entrants alike. No longer is a business limited to deciding which of a few top-level domains, such as .com, .net,…more

Domain Names, Filing Fees, gTLD, ICANN, Trademarks

See all updates »

BitBlog Bi-Weekly Update - May 2020

With the world slowly coming out of the COVID-19 lock down and the economy hopefully on the path to recovery there have been many developments in the blockchain / crypto space over the last few weeks…more

Bitcoin, Blockchain, CFTC, Cryptocurrency, Digital Assets

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Louisiana Insurance Department Catastrophe Response Plans

The Louisiana Insurance Department (“Department”) recently sent e-mail notifications to numerous third party administrators (“TPA”) regarding the failure to file their Catastrophe Response Plans with the Department by June 1,…more

Catastrophic Events, Consumer Insurance Products, Emergency Response, Insurance Regulations, Louisiana

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Fee Guidelines For Attorneys In Larger Chapter 11 Cases

Following two public comment periods spanning more than a year as well as a public meeting, the Office of the United States Trustee (the "UST") has issued new guidelines for attorney compensation in larger chapter 11 cases. The…more

Attorney's Fees, Chapter 11, Commercial Bankruptcy

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IRS Identifies Monetized Installment Sales as a Listed Transaction

On August 4, 2023, the IRS published proposed regulations that, if finalized, would identify monetized installment sale transactions as a listed transaction. Sellers, intermediaries and other involved parties would be required…more

Installment Agreements, Internal Revenue Code (IRC), IRS, Proposed Regulation, Purchase Agreement

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Understanding How the Corporate Transparency Act Will Apply to the Delaware Statutory Trust Structure

What is the Corporate Transparency Act? In general terms, the Corporate Transparency Act (the “CTA”) requires reporting to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”) of personal direct…more

Anti-Corruption, Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes

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California’s New Statewide Rent Control – What You Need to Know

As expected, California’s legislature passed AB 1482 this week, which imposes statewide rent control, restricting the ability of landlords to terminate certain tenancies without just cause, and further restricting the ability of…more

Landlords, Lease Termination, Municipalities, New Legislation, No-Fault Act

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What’s In a Name? – Labeling Alternatives to Meat Products

Manufacturers, producers and sellers of meat substitutes, including popular plant-based products and emerging cell-cultured products, can now be subject to criminal penalties in Missouri for calling their products “meat,” or by…more

Agricultural Sector, Food Labeling, Food Manufacturers, Food Safety, Food Supply

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

See all updates »

Proposed And Final Rules Released Regarding The ACA's Individual Mandate

In This Issue: - Minimum Essential Coverage ..HHS Proposed Rule - Shared Responsibility Payments and Exemptions ..HHS Proposed Rule ..IRS Proposed Rule ..IRS Final Rule - Essential Health Benefits …more

Affordable Care Act, Congressional Budget Office, Department of Health and Human Services (HHS), Essential Health Benefits, Health Insurance Exchanges

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“Outlook Not So Good” – An Employer’s Guide to the NLRB’s 2023 Agenda

“Should Employers have any hope for impartiality and good decisions from the National Labor Relations Board (“NLRB” or the “Board”) in 2023?”  Posed to the old Magic 8 Ball, the answer is “Don’t count on it.”…more

Collective Bargaining, Employer Liability Issues, Labor Reform, Labor Relations, Make-Whole Doctrine

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SEC Division of Examinations Announces 2022 Examination Priorities

Each year, the U.S. Securities and Exchange Commission’s (SEC) Division of Examinations (Division) prioritizes the examination of certain practices, products and services that it believes present potentially heightened risks to…more

Anti-Money Laundering, Capital Formation, Capital Markets, Investor Protection, Regulatory Agenda

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POTUS Changes WOTUS (“Waters of the United States”)

On December 28, 2018, the EPA published in the Federal Register a revised definition of “waters of the United States” (the “Proposed Rule”), as used in the Clean Water Act, to replace the current definition that was finalized in…more

Clean Water Act, Environmental Policies, Environmental Protection Agency (EPA), Jurisdictional Determination (JD), Navigable Waters

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"Please Pay No Attention to the Microphone:” DOJ Announces New Program Offering Protections to Criminal Whistleblowers

On April 15, 2024, the Criminal Division of the U.S. Department of Justice (“DOJ”) released new guidance relating to a Pilot Program on Voluntary Self-Disclosures for Individuals, promising to offer protection from criminal…more

Cooperative Compliance Regime, Corporate Governance, Corporate Misconduct, Criminal Prosecution, Department of Justice (DOJ)

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

See all updates »

Ninth Circuit Reverses Landmark Wit Case Addressing Behavioral Health Coverage

The President and his administration continue to tout their efforts to strengthen coverage for behavioral health care, including significantly increasing behavioral health spending and strengthening parity between physical and…more

Biden Administration, Denial of Insurance Coverage, Employee Retirement Income Security Act (ERISA), Health Insurance, Health Plan Sponsors

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Two Week Old DOJ COVID-19 Fraud Task Force Announces First Wave of Prosecutions—Many More Are Likely On The Horizon

Last week, in light of the Department of Justice’s newly-formed COVID-19 Fraud Enforcement Task Force, we cautioned that COVID-related prosecutions were likely imminent. And on the heels of this DOJ task force, we are already…more

Anti-Corruption, Coronavirus/COVID-19, Corruption, Department of Justice (DOJ), Enforcement Actions

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What the Health Care Industry Needs to Know About the Corporate Transparency Act

A new federal law requires health care business entities to disclose personal information and photographs of persons with ownership and control over their business. The Centers for Medicare & Medicaid (CMS) and other federal and…more

Beneficial Owner, Business Ownership, Centers for Medicare & Medicaid Services (CMS), Corporate Transparency Act, Disclosure Requirements

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SEC Proposes Amendments to Form PF to Drastically Expand Reporting Requirements for Private Fund Managers

On January 26, 2022, the Securities and Exchange Commission (the “SEC”) approved a proposal to amend Form Private Fund (“Form PF”) to (i) require additional reporting from advisers to large hedge funds and private equity funds,…more

Comment Period, Financial Regulatory Reform, Form PF, Hedge Funds, Investment Adviser

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Privacy and Data Security: 2017 Year in Preview

Few issues keep executives awake at night more than Privacy and Data Security. New regulations and threats alike are plentiful, varied, and evolving. The rate of change for cybersecurity and information governance continues to…more

Affordable Care Act, Apple, China, Cloud Computing, Cybersecurity

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Draft Guidance: Pharmacy Compounding Of Human Drug Products Under Section 503A Of The Federal Food, Drug, And Cosmetic Act

Following enactment of the Drug Quality and Security Act last month, FDA has quickly issued a new guidance for compounding pharmacies that choose to not register as "outsourcing facilities" and subject themselves to federal…more

Drug Compounding, Food and Drug Administration (FDA), Pharmaceutical Industry, Pharmacies, Prescription Drugs

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FinCEN Publishes Updated FAQs to Assist in Reporting Compliance

The Financial Crimes Enforcement Network (“FinCEN”) recently published updates to its list of Frequently Asked Questions (“FAQs”) to assist entities in complying with the beneficial ownership reporting requirements of the…more

Anti-Corruption, Anti-Money Laundering, Beneficial Owner, Corporate Counsel, Corporate Transparency Act

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Congress Takes Steps to Prioritize Youth Mental Health

Recognizing the urgent need to increase access to mental health and substance use services for young people, Congress is taking significant legislative steps to strengthen the federal government’s response to the nationwide…more

Healthcare, Healthcare Reform, HRSA, Mental Health, Prescription Drugs

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Guidance Released on Inflation Reduction Act Domestic Content Tax Credits

Background - On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (“IRA”). Two of the key objectives of the IRA are to incentivize the industry to produce certain types of renewable energy…more

Buy America, Energy Projects, Federal Transit Administration, Inflation Reduction Act (IRA), Infrastructure

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Lender's Edge Newsletter - January 2019

A borrower’s request for a payoff letter on a secured commercial loan is typically a completely noncontroversial matter: an honest borrower has located a buyer for its property, or found another lender to refinance the…more

Commercial Loans, Consumer Financial Products, Financial Services Industry, Lenders, Payoff Requirements

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BitBlog Bi-Weekly Update - May 2020

With the world slowly coming out of the COVID-19 lock down and the economy hopefully on the path to recovery there have been many developments in the blockchain / crypto space over the last few weeks…more

Bitcoin, Blockchain, CFTC, Cryptocurrency, Digital Assets

See all updates »

Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

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Delaware Court of Chancery Rejects Lawyer-Driven Stockholder Books and Records Demand in Wilkinson v. Schulman

Stockholder books and records demands are investigatory tools that often are a prelude to litigation directed at corporate fiduciaries. In rejecting a stockholder books and records demand, the Delaware Court of Chancery recently…more

Books & Records, Business Litigation, Delaware General Corporation Law, Discovery, Evidence

See all updates »

Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

See all updates »

Courts Split on How to Determine Statutory Damages for Copyright Infringement

The recent decision in Energy Intelligence Group, Inc. v. CHS McPherson Refinery, Inc. highlights a circuit split regarding how courts determine the statutory damages available for copyright infringement where multiple…more

Copyright, Copyright Infringement, Copyright Litigation, Intellectual Property Protection, Loss in Economic Value

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Once-in-a-Generation Opportunity to Influence Stark Law Implementation Rules Starts This Week

We are on the clock. As an industry, we have 75 days to comment on the rules published in the Federal Register this week about how the Stark Law is implemented…more

Anti-Kickback Statute, Comment Period, False Claims Act (FCA), Fraud and Abuse, Health Care Providers

See all updates »

Federal Reserve Announces New Details for Term Asset-Backed Securities Loan Facility (TALF)

On March 23 the Federal Reserve announced the creation of the Term Asset-Backed Securities Loan Facility, or TALF to support the asset-backed securities (ABS) market.  The new facility (commonly referred to in the market as TALF…more

Asset-Backed Securities, CMBS, Collateral, Collateralized Loan Obligations, Federal Reserve

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Positive Momentum Behind Congressional Efforts to Avert Medicare Cuts

Health Care providers have been advocating for Congress to avert a series of impending Medicare reimbursement cuts slated to take effect in January of 2022 – an issue that has garnered bipartisan support. Congressional…more

Health Insurance, Healthcare, Healthcare Reform, Medicare, PAMA

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Reimbursement and Payor Dispute Update

Strategies for Complying with Price Transparency and Surprise Billing Laws - State legislatures and the federal government have been busy the past 12 months churning out laws that impose new disclosure and billing obligations on…more

Coronavirus/COVID-19, Health Care Providers, Health Insurance, Healthcare Reform, Infectious Diseases

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Medicare Continues its Updates to Provider Enrollment Policies as Part of Efforts to Enhance Program Integrity and Transparency

The Centers for Medicare & Medicaid Services (“CMS”) continued its efforts to increase oversight of the Medicare program by updating Medicare provider enrollment regulations and policies through recent regulatory and…more

Centers for Medicare & Medicaid Services (CMS), Enrollment, Health Care Providers, Health Insurance, Healthcare

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FTC Final Rule Banning Most Non-Competes Passes – What Nonprofits Need to Know

On April 23, 2024, the Federal Trade Commission (“FTC”) conducted a special Open Commission Meeting to vote on a Final Rule (the “Rule”) banning most non-compete clauses as an “unfair method of competition.” By a vote of 3-2,…more

501(c)(3), Competition, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC)

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U.S. Treasury Proposes Guidance on Corporate Transparency Act Beneficial Ownership Information Reporting

The U.S. Department of Treasury, on behalf of the Financial Crimes Enforcement Network (“FinCEN”), has invited the public to submit comments on the information to be collected in the beneficial ownership information (“BOI”)…more

Anti-Corruption, Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes

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Cryptocurrency Class Action Lawsuits: A New Frontier

Cryptocurrencies, like Bitcoin and Ethereum, had a breakout year in 2017. The price of Bitcoin rose from approximately $1,000 per Bitcoin on January 1, 2017, to $13,000 per Bitcoin on December 31, 2017, with a high of…more

Bitcoin, Blockchain, Class Action, Cryptocurrency, Digital Currency

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Fall Congressional Forecast: Eye on Federal Funding and Health Care

Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the…more

Abortion, Biden Administration, Continuing Resolution, Federal Funding, Food and Drug Administration (FDA)

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SEC Commissioner’s Public Comments May Signal Stiffer Corporate Stronger Misconduct Penalties on the Horizon

Earlier this week at a talk before the Council of Institutional Investors, U.S. Securities and Exchange (“SEC”) Commissioner, Caroline Crenshaw, argued that the enforcement must play a “central role” with regulators and require…more

Corporate Misconduct, Enforcement Actions, Investment, Penalties, Securities and Exchange Commission (SEC)

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Don't Get Your Feathers Ruffled: The Value of Exclusivity Provisions in Real Estate Agreements

Say you decide to open a chicken restaurant selling your secret family recipe chicken. You find the perfect location, sign the lease, move in, and open for business. Sales are brisk when a few weeks later you see a construction…more

Commercial Leases, Commercial Real Estate Market, Exclusivity Clauses, Landlords, Leases

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Colorado Introduces Bill to Promote and Expand Carbon Dioxide Capture and Sequestration

A bill to expand the Colorado Energy and Carbon Management Commission’s (“Commission”) ability to regulate and promote carbon dioxide capture and sequestration was introduced on February 27. HB24-1346 expands the authority of…more

Carbon Capture and Sequestration, Carbon Emissions, Colorado, Energy Policy, Energy Reform

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IVF Services Now Caught in the Crosshairs

Recent legal developments in Alabama demonstrate that fertility care stakeholders should prepare for additional state regulation of in vitro fertilization (“IVF”) and other assisted reproductive technology (“ART”) services in…more

AL Supreme Court, Alabama, Dobbs v. Jackson Women’s Health Organization, Fertility Treatments, Health Care Providers

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Regulatory Updates for Non-Hospital Quality Programs

The Washington Department of Health (DOH) has amended WAC 246-50, the rules applicable to coordinated quality improvement programs (CQIPs) for non-hospital organizations.  The amendments go into effect on May 21, 2021…more

Health Care Providers, Healthcare Reform, Physicians, Quality Incentive Program (QIP), Regulatory Agenda

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New SAMHSA Rule Expands Access to Medications for the Treatment of Opioid Use Disorder

On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes that…more

Department of Health and Human Services (HHS), Final Rules, Health Care Providers, Healthcare, Healthcare Reform

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MACRA: Proposed Changes to the Merit-Based Incentive Payment System Track

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on the Medicare Quality Payment Program (QPP) in the Federal Register1 on June 30, 2017. This rule proposes the QPP program requirements for calendar…more

CEHRT, Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Medicare, Medicare Access and CHIP Reauthorization (MACRA)

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Don't be Fooled by the Name... The Small BREW Act Could Have a Big Impact on Craft Breweries

The Small Brewer Reinvestment and Expanding Workforce Act, known as the "Small BREW Act", is bipartisan legislation introduced to Congress in early 2015. The overall goal of the Small BREW Act is to revamp the federal excise tax…more

Beer, Breweries, Business Taxes, Federal Taxes, Popular

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False Claims Act Recoveries During 2021

On February 1, 2022, the United States Department of Justice (DOJ) announced that it had recovered $5.6 billion from False Claims Act (FCA) Cases during fiscal year 2021. Each year, the DOJ publishes statistics about its…more

Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse, Healthcare

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FDA Finalizes Rule Regulating Laboratory Developed Tests

FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of these…more

Clinical Laboratories, Final Rules, Food and Drug Administration (FDA), Healthcare, Laboratory Developed Tests

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ASIC Bans Former BitConnect Front-man

John Louis Anthony Bigatton will not be providing financial services in Australia and likely not anywhere else, anytime soon. On Thursday, September 3, 2020, the Australian Securities and Investments Commission (“ASIC”)…more

ASIC, Australia, Bitcoin, Cease and Desist Orders, Cryptocurrency

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Fireworks Are Coming Before Independence Day

Mark your calendars for July 3—the date we will likely learn whether a Texas Court will enjoin the FTC Rule banning non-competes from taking effect on September 4. This week, Judge Ada Brown, the presiding judge in Ryan, LLC v…more

Competition, Confidential Information, Employer Liability Issues, Employment Contract, Federal Labor Laws

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WARN-ings May Be Required Before a RIF or Shut Down

Recent layoffs at several high profile companies, and the putative class actions filed in their wake, highlight the importance of legal compliance when making and effecting these difficult decisions…more

Employer Liability Issues, Federal Labor Laws, Hiring & Firing, Layoff Notices, Layoffs

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The 80/20 Rule is Here: CMS Finalizes HCBS Care Worker Payment Requirements

In May 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a series of rule changes intended to help promote the availability of home and community-based services (“HCBS”) for Medicaid beneficiaries. Chief…more

Centers for Medicare & Medicaid Services (CMS), Compensation & Benefits, Fair Labor Standards Act (FLSA), Health Care Providers, Healthcare Workers

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

See all updates »

AI is Fueling a Major Contract Dispute in the Music Industry: Why it Matters for Your Business

Whether or not you are a TikTok user, you have likely heard about how the platform allows creators to combine music clips with original content to create viral videos. The ability for users to leverage an extensive music…more

Artificial Intelligence, Contract Disputes, Corporate Counsel, Intellectual Property Protection, Mobile Apps

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Lender's Edge Newsletter: January 2018

Are Lenders Entitled to Insurance Proceeds When Foreclosing? A lender’s right to insurance proceeds after foreclosure depends on the type of loss payable clause contained in the insurance policy and the timing of the loss…more

Financial Services Industry, Foreclosure, Insurance Industry, Lenders, Mortgages

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Colorado Supreme Court Vindicates the Colorado Oil and Gas Commission: Recent Ruling In Favor of the Oil and Gas Industry

In an important victory for Colorado’s oil and gas industry, the Colorado Supreme Court unanimously supported the decision of the Colorado Oil and Gas Conservation Commission (the “Commission”) to decline a rulemaking sought by…more

Climate Change, CO Supreme Court, Environmental Claims, Mineral Extraction, Oil & Gas

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NLRB Releases Advice Memos Approving Employer Work Rules Under New Boeing Standard

On July 13, 2018, the General Counsel of the National Labor Relations Board (“NLRB” or “Board”) released several memos authored by the Board’s Division of Advice, which offer further guidance to employers about how the Board…more

Boeing, Corporate Counsel, Employee Rights, Employer Liability Issues, Employment Policies

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Delaware Court of Chancery Rejects Lawyer-Driven Stockholder Books and Records Demand in Wilkinson v. Schulman

Stockholder books and records demands are investigatory tools that often are a prelude to litigation directed at corporate fiduciaries. In rejecting a stockholder books and records demand, the Delaware Court of Chancery recently…more

Books & Records, Business Litigation, Delaware General Corporation Law, Discovery, Evidence

See all updates »

Medicare Changes to Make Drug Coverage More Manageable in 2025

Within the last few months, the Centers for Medicare and Medicaid Services (CMS) has issued guidance that will reduce the financial burdens of paying for prescription drug coverage for Medicare patients. The guidance outlines…more

Biden Administration, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Insurance, Inflation Reduction Act (IRA)

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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Contact Sports in the Era of COVID-19: How Schools and Amateur Sports Leagues May Face New Liability

This brief article explores some of the legal issues that may arise in the era of COVID-19 when restrictions are eased and participation in contact sports resumes in schools and amateur sports leagues…more

Assumption of the Risk, Athletes, Coronavirus/COVID-19, Educational Institutions, Liability

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Patient-Centered Sustainable Health Care

I. INTRODUCTION - Over the past two years, global events reshaped the health care industry by shifting the priorities of the industry’s key stakeholders. In the post-Covid-19 economy, quick responses to short-term problems…more

Healthcare, Healthcare Reform, Hospital Mergers, Patient-Specific, Patients

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Missouri Legislature Approves Six-Year Solar Rebate Phase-Out

As one of the final acts of the legislative session, on May 17th the Missouri legislature approved an amendment that will phase out the Missouri solar rebate between 2014 and 2020…more

Proposed Amendments, Rebates, Solar Energy

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Update: SEC Releases Long-Awaited Proposed Crowdfunding Rules

In This Issue: - Requirements and Obligations Governing Crowdfunding Offerings - Regulation of Crowdfunding Portals - Additional Notable Provisions of the Proposed Rules - Next Steps - For More Information…more

Crowdfunding, Disclosure Requirements, Funding Portal, General Solicitation, JOBS Act

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Franchise Issues Arising Out of the Upcoming Employer Mandates of COVID-19 Vaccinations

On September 9, 2021, President Biden announced through a COVID-19 Action Plan that his administration is requiring many employers to mandate their employees be vaccinated against COVID-19. The announcement covered federal…more

Biden Administration, Coronavirus/COVID-19, Emergency Management Plans, Employer Liability Issues, Employer Mandates

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Fireworks Are Coming Before Independence Day

Mark your calendars for July 3—the date we will likely learn whether a Texas Court will enjoin the FTC Rule banning non-competes from taking effect on September 4. This week, Judge Ada Brown, the presiding judge in Ryan, LLC v…more

Competition, Confidential Information, Employer Liability Issues, Employment Contract, Federal Labor Laws

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TCPA News: Businesses May be Liable to New Owners of Previously-Opted-In Mobile Numbers

On July 10, 2015, the Federal Communications Commission issued a 138-page Declaratory Ruling and Order approving nearly two dozen proposals to the rules and regulations implementing the Telephone Consumer Protection Act (TCPA),…more

Cell Phones, FCC, Mobile Devices, Opt-Outs, Robocalling

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FDA Targets Medical Device Companies

FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to…more

Biotechnology, Enforcement, Enforcement Actions, Food and Drug Administration (FDA), Healthcare

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Don’t Leave a Print: Biometric Compliance for Employers

With many employers embracing new technology to achieve efficiencies in the workplace, companies using increasingly popular biometric programs must take steps to ensure that the use of these systems does not violate the law in…more

Biometric Information, Data Collection, Data Privacy, Data Security, Employer Liability Issues

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Estate Planning During Periods of Inflation and Market Volatility

Earlier this year the stock market entered bear market territory.  This happens when the market declines more than 20% or more from its most recent high.  The market decline has been attributed to several factors including…more

Charitable Remainder Trust, Estate Planning, Estate Tax, Estate-Tax Exemption, Gift Tax

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The Proposed Build Back Better Act Moves Forward After the House Passes a Revised Version of the Bill

Overview - Over the past year, several tax law changes have been proposed by the Biden administration and, in September 2021, draft legislative language was circulated, which set forth proposed changes to the Internal…more

Biden Administration, Capital Gains Tax, Corporate Taxes, Foreign Derived Intangible Income (FDII), Foreign Tax Credits

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A Preview Of Expected 2014 FDA And Legislative Actions Relating To The Food Industry

In This Issue: - Food Safety Modernization Act ..Produce Safety ..Human Food Risk Analysis ..Foreign Supplier Verification ..Accreditation of Food Safety Auditors ..Animal Food Risk Analysis…more

Food and Drug Administration (FDA), Food Safety, Foreign Suppliers, FSMA

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California’s AB 3129 Continues National Trend of Scrutinizing Private Equity Investments in the Health Care Industry

The California legislature is considering a bill that could severely impact the ability for private equity companies and hedge funds to operate in the California health care industry. AB 3129, introduced by Assembly Member Jim…more

Acquisition Agreements, California, Healthcare, Hedge Funds, Investment

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Beware – FDA is “Modernizing” the 510(k) Program

On November 26, 2018, FDA Commissioner Scott Gottlieb, M.D. and the Director of the Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D. announced FDA’s intention to take multiple actions in the near future to…more

510(k) RTA, FDA Approval, Food and Drug Administration (FDA), Life Sciences, Medical Devices

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Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for…more

Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), EHR, Exempt Organizations

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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New Guidance on Employee-Owned Device Discovery

As technology continues to evolve, organizations are increasingly facing challenges concerning whether, and to what extent, they allow employees to utilize their own devices for work purposes. When employees use their own…more

Bring Your Own Device (BYOD), Discovery, Electronically Stored Information, Employer Liability Issues, Employment Policies

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Federal Circuit Addresses Obviousness of Polymorphs in Grunenthal GmbH v. Alkem Labs. Ltd., No. 2017-1153 (Fed. Cir. Mar. 28, 2019)

For the first time, on March 28, 2019, the Federal Circuit addressed obviousness of polymorph claims based on a known approach to polymorph screening, finding no reasonable expectation of success…more

Hatch-Waxman, Intellectual Property Litigation, Intellectual Property Protection, Obviousness, Pharmaceutical Industry

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Stars Align As Second Circuit Limits Orion

The Second Circuit recently reversed and remanded for further proceedings a S.D.N.Y decision dismissing claims asserted by POLSINELLI clients CBF Indústria de Gusa S/A, Da Terra Siderúrgica LTDA and several other Brazilian…more

Arbitration, Arbitration Awards, Brazil, Financial Institutions, Foreign Judgments

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Ninth Circuit Reverses Landmark Wit Case Addressing Behavioral Health Coverage

The President and his administration continue to tout their efforts to strengthen coverage for behavioral health care, including significantly increasing behavioral health spending and strengthening parity between physical and…more

Biden Administration, Denial of Insurance Coverage, Employee Retirement Income Security Act (ERISA), Health Insurance, Health Plan Sponsors

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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Regulatory Overreach/Litigation Remedies To Curtail Regulatory Excess by Federal Trade Commission

With the rise of large-scale, high-profile data breaches, the Federal Trade Commission has expressed its intent to hold companies accountable. (See “Consumer Financial Protection Circular 2022-04,” Consumer Financial Protection…more

Data Breach, Data Management, Data Security, Enforcement Actions, Federal Trade Commission (FTC)

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New York Targets Real Estate Owners in New LLC Transparency Law

Riding a wave of ownership disclosure laws began with the passage of the federal Corporate Transparency Act (CTA), on December 22, 2023, Governor Hochul signed New York’s own “LLC Transparency Act” (the NY-LLCTA), passed by the…more

Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes, FinCEN

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Lender's Edge Newsletter: January 2018

Are Lenders Entitled to Insurance Proceeds When Foreclosing? A lender’s right to insurance proceeds after foreclosure depends on the type of loss payable clause contained in the insurance policy and the timing of the loss…more

Financial Services Industry, Foreclosure, Insurance Industry, Lenders, Mortgages

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Cuts In Services May Leave Bigger Wounds

In a recent open letter, the Illinois Department of Financial and Professional Regulation (the "Department") advised providers of cuts in the Department's Medical Unit that will negatively impact the state's healthcare…more

Budget Cuts, Healthcare, Licenses, Physicians

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Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary…more

Affordable Care Act, Covered Entities, Drug Pricing, Health Care Providers, Healthcare

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Southern District of New York Says Portions of Department of Labor’s FFCRA Final Rule “Jumped the Rail” and Are Vacated

On April 1, 2020, the United States Department of Labor (DOL) issued a Final Rule implementing the Families First Coronavirus Response Act (FFCRA).  Shortly thereafter, the State of New York filed suit against the DOL, arguing…more

Coronavirus/COVID-19, Department of Labor (DOL), Families First Coronavirus Response Act (FFCRA), Family and Medical Leave Act (FMLA), Relief Measures

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Using Endowed Funds in a Crisis: Key Considerations

It goes without saying that we are living in uncertain times and are experiencing events that are reshaping our lives in ways that many of us believed only to exist in science fiction books and movies. Nevertheless, while we all…more

Charitable Organizations, Coronavirus/COVID-19, Endowment Funds

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The Polsinelli Pulse: Mitigating Litigation Risk at the Deal Table and Beyond - Vol. 3

Mergers & Acquisitions And Paycheck Protection Program: Proceed With Caution - In Spring 2020, Congress adopted the CARES Act, which authorized $350 billion for the Paycheck Protection Program (“PPP”). With an additional $310…more

Acquisition Agreements, C-Suite Executives, CARES Act, Coronavirus/COVID-19, Cyber Insurance

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The Legacy IRA Act Meets the EARN Act: A Gift or a Lump of Coal

Generally, donors who are over the age of 70 ½ can direct distributions to be made from their individual retirement account (IRA) of up to $100,000 per year to public charities (other than to fund a donor advised fund). This…more

Charitable Rollover, Employee Benefits, Individual Retirement Account (IRA), IRA Rollovers, Proposed Legislation

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California says “Goodbye” to the De Minimis Doctrine

For years, courts applied the de minimis doctrine “to excuse the payment of wages for small amounts of otherwise compensable time upon a showing that the bits of time are administratively difficult to record.” Troester v…more

CA Supreme Court, De Minimis Claims, De Minimus Doctrine, Employer Liability Issues, Employment Litigation

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Asbestos Exposure Liability Decision May Affect Future "Take Home" Cases

Following recent court action, defendants up against "take-home" asbestos exposure claims may need to rethink their legal strategy. The Northern District of Illinois recently denied a Motion for Reconsideration of a Motion…more

Asbestos, Asbestos Litigation, Duty of Care, Negligence, Take-Home Exposure

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Health Care Reimbursement and Payor Dispute Update - September 2022

Co-Location and the Provider-Based Rules – No News is…Good News? On July 15, the Centers for Medicare & Medicaid Services ("CMS") released the 2023 Outpatient Prospective Payment System proposed rule (“OPPS Proposed Rule”),…more

Centers for Medicare & Medicaid Services (CMS), Critical Access Hospitals, Health Care Providers, Health Insurance, Healthcare

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U.S. Court Of Appeals Decision Likely To Impact State Transmission And RES Policies

On June 7th, 2013, the U.S. Court of Appeals for the Seventh Circuit issued an opinion that could have significant impacts on transmission and renewable energy policies all across the country…more

FERC, MISO, Renewable Energy, RTO, Transmission Lines

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Top Issues in Behavioral Health for 2022

Behavioral Health M&A Will Remain Hot in 2022 - Behavioral health had its most active year in 2021, which came on the heels of very active years that preceded it. There are many factors that contributed to this and that…more

Centers for Medicare & Medicaid Services (CMS), Health Insurance, Healthcare, Healthcare Reform, Joint Venture

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SEC Proposes Changes to Modernize and Simplify Equity Compensation Rules and Registration Obligations

On November 24, 2020, the Securities and Exchange Commission (“SEC”) proposed amendments to Rule 701 and Form S-8 (the “Proposals”) under the Securities Act of 1933, as amended (the “Securities Act”)…more

Disclosure Requirements, Form S-8, Publicly-Traded Companies, Rule 701, Securities and Exchange Commission (SEC)

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Reopening Hospital Service Lines: A Playbook for Moving Forward

The COVID-19 pandemic has created severe financial and operational difficulties for hospitals. Rapidly responding to a novel pathogen within a declared Public Health Emergency (PHE), while experiencing decreased revenues as a…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Responsibilities, Re-Opening Guidelines, Return-to-Work Agreements

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U.S. Court Of Appeals Decision Likely To Impact State Transmission And RES Policies

On June 7th, 2013, the U.S. Court of Appeals for the Seventh Circuit issued an opinion that could have significant impacts on transmission and renewable energy policies all across the country…more

FERC, MISO, Renewable Energy, RTO, Transmission Lines

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United States v. Gratkowski - Beware of Inanimate Objects That Violate Your Privacy

In Philip K. Dick’s novel Ubik, the sci-fi legend warned the world of the dangers of inanimate objects that could violate our privacy. In a virtual nod to Ubik and Dick, the Fifth Circuit Court of Appeals ruled the privacy…more

Bitcoin, Child Pornography, Criminal Investigations, Digital Currency, Financial Transactions

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California’s New Statewide Rent Control – What You Need to Know

As expected, California’s legislature passed AB 1482 this week, which imposes statewide rent control, restricting the ability of landlords to terminate certain tenancies without just cause, and further restricting the ability of…more

Landlords, Lease Termination, Municipalities, New Legislation, No-Fault Act

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H-1B Cap Season

USCIS has confirmed they will open the new H-1B Lottery pre-registration portal on March 1, 2020. The H-1B visa is available to companies wishing to hire a foreign worker to fill a “specialty occupation” which is defined as a…more

Foreign Nationals, Foreign Workers, H-1B, Highly-Skilled Workers Visa, Hiring & Firing

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Reopening the Economy and Getting Back to Business: Will Liability Waivers Protect My Business?

Last week, in our blog post entitled Reopening the Economy and Getting Back to Business: Business Owners’ Liability Risk When Dealing with Customers and Others, we talked about the various considerations and risk mitigation…more

Coronavirus/COVID-19, Liability, Negligence, Waivers

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Environment, Energy & Infrastructure Landscape in 2023

THE PLAYERS - The Administration - While it is unusual for a President to enjoy four years of service from his cabinet leaders that oversee the Environmental Protection Agency and the Departments of Energy, the Interior, and…more

Administrative Appointments, Biden Administration, Congressional Committees, Critical Infrastructure Sectors, Energy Policy

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Understanding How the Corporate Transparency Act Will Apply to the Delaware Statutory Trust Structure

What is the Corporate Transparency Act? In general terms, the Corporate Transparency Act (the “CTA”) requires reporting to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”) of personal direct…more

Anti-Corruption, Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes

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FTC and DOJ Signal Greatly Increased Scrutiny of Private Equity Firms’ Acquisitions in Health Care

The top enforcers at the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) are sending strong signals that private equity (PE) firms are likely to be the next target in the Biden…more

Acquisitions, Antitrust Provisions, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Department of Justice (DOJ)

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Colorado Supreme Court to Rule on Yet Another Key Construction Defects Issue

On July 5, 2016, the Colorado Supreme Court announced it will consider the construction defects case of Forest City Stapleton, Inc., et al. v. Rogers. In this case the Colorado Court of Appeals, for the first time, imposed an…more

CO Supreme Court, Construction Defects, Construction Industry, Construction Litigation, Construction Project

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The Time is Now for Employers to Prepare for Illinois’ Paid Leave for All Workers Act

On January 1, 2024, Illinois will join Maine and Nevada as the only U.S. states to mandate that covered employers provide their employees with earned paid leave that can be used for any reason. Generally, the Paid Leave for All…more

Earned Sick Time, Employee Benefits, Employees, Employer Liability Issues, Illinois

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Meat Processing: COVID Liabilities

In the midst of the pandemic, meat processing facilities have struggled to meet demand while protecting employees. Governmental regulations, orders and guidelines often have seemed to be inconsistent with one another. Even…more

Centers for Disease Control and Prevention (CDC), Coronavirus/COVID-19, Defense Production Act, Farm Animals, Food Manufacturers

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California’s Amended Data Broker Registration Law

In October 2023, California Governor Gavin Newsom signed Senate Bill (S.B.) 362 into law, amending California’s data broker registration law. By January 31, 2024, qualifying data brokers must register with the California Privacy…more

California, California Consumer Privacy Act (CCPA), California Privacy Protection Agency (CPPA), Consumer Privacy Rights, Cybersecurity

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How to Protect Large Deposits over $250,000

Individuals and businesses have several methods for avoiding or limiting risk of loss upon the failure of a depository bank. …more

Banks, Deposit Accounts, FDIC, Financial Institutions, Silicon Valley

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Mandatory but not Jurisdictional – SCOTUS Decides What Employers Must do to Kick Charge-less Title VII claims

On June 3, 2019, the U.S. Supreme Court in Fort Bend County, Texas v. Davis unanimously held that Title VII’s charge-filing requirement is mandatory for claimants, but not jurisdictional.  Stated plainly, employees can still…more

Affirmative Defenses, Amended Complaints, Appeals, Charge-Filing Preconditions, Civil Rights Act

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Illinois Supreme Court Allows Remote Jury Selection

The Illinois Supreme recently entered an Order allowing for immediate remote jury selection in an attempt to alleviate the COVID-19 pandemic’s enormous impact on the court system. See In re: Illinois Courts Response to COVID-19…more

Coronavirus/COVID-19, Infectious Diseases, Judicial Proceedings, Jury Selection, Jury Trial

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Time for a Wellness Check on your Wellness Program? New EEOC Regulations Could Diagnose Need for Change

In light of new rules from the Equal Employment Opportunity Commission (EEOC), employers should examine their wellness programs now (and during open enrollment for next year) to determine the potential impact of the final…more

Americans with Disabilities Act (ADA), Employee Benefits, Employer Group Health Plans, Equal Employment Opportunity Commission (EEOC), Genetic Discrimination

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California says “Goodbye” to the De Minimis Doctrine

For years, courts applied the de minimis doctrine “to excuse the payment of wages for small amounts of otherwise compensable time upon a showing that the bits of time are administratively difficult to record.” Troester v…more

CA Supreme Court, De Minimis Claims, De Minimus Doctrine, Employer Liability Issues, Employment Litigation

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Top Immigration Updates for U.S. Employers during COVID-19 National Emergency

The COVID-19 National Emergency has brought a host of challenges to employers in the United States, including travel, compliance with employment verification processes, and hiring and maintaining immigration status for foreign…more

Canada, Coronavirus/COVID-19, Department of Labor (DOL), Employment Eligibility Verification, Foreign Nationals

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Supreme Court Gives Voice To Private Company Whistleblowers

Lawson v. FMR LLC - In a decision giving private company employers cause to reassess their employee policies and protocols, on March 4, 2014 the U.S. Supreme Court issued a split decision in Lawson v. FMR LLC that…more

Board of Directors, Contractors, FMR LLC, Lawson v FMR, Sarbanes-Oxley

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SECURE 2.0: Retirement Plan Rules Get a Makeover!

SECURE 2.0, which was signed into law on December 29, 2022 as part of the larger Consolidated Appropriations Act, is the most wide-sweeping retirement plan legislation enacted in more than a decade. It contains a myriad of…more

Compensation & Benefits, Consolidated Appropriations Act (CAA), Employee Benefits, New Legislation, Regulatory Reform

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Jury Verdict Invalidated a Patent Under Section 101

On September 12, 2019, after about six hours of deliberating, a jury in the United States District Court for the Eastern District of Texas determined that no infringement had been committed in a suit filed by PPS Data LLC…more

Financial Services Industry, Intellectual Property Protection, Patent Infringement, Patent Invalidity, Patent Litigation

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Ninth Circuit Reverses Landmark Wit Case Addressing Behavioral Health Coverage

The President and his administration continue to tout their efforts to strengthen coverage for behavioral health care, including significantly increasing behavioral health spending and strengthening parity between physical and…more

Biden Administration, Denial of Insurance Coverage, Employee Retirement Income Security Act (ERISA), Health Insurance, Health Plan Sponsors

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Patient-Centered Sustainable Health Care

I. INTRODUCTION - Over the past two years, global events reshaped the health care industry by shifting the priorities of the industry’s key stakeholders. In the post-Covid-19 economy, quick responses to short-term problems…more

Healthcare, Healthcare Reform, Hospital Mergers, Patient-Specific, Patients

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George Costanza and the Supreme Court Align in Ruling This Week on Section 11 of the Securities Act of 1933

In a classic Seinfeld episode, George Costanza opined: "it's not a lie, if you believe it". In a ruling handed down on March 24th, the Supreme Court agreed with this sentiment as it concerned claims brought under Section 11 of…more

Material Misstatements, Omnicare v Laborers District Council, Registration Statement, SCOTUS, Securities Act of 1933

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MACRA: Proposed Changes to the Merit-Based Incentive Payment System Track

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on the Medicare Quality Payment Program (QPP) in the Federal Register1 on June 30, 2017. This rule proposes the QPP program requirements for calendar…more

CEHRT, Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Medicare, Medicare Access and CHIP Reauthorization (MACRA)

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New EDPB Guidance on International Transfers Following Schrems II

On November 10, the European Data Protection Board (“EDPB”) released its “Recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data” (the…more

Corporate Counsel, Cybersecurity, Data Protection, EU, European Data Protection Board (EDPB)

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Texas Supreme Court Confirms Texas Home-Equity Lenders Are Entitled to Equitable Subrogation Irrespective of Failures to Correct Curable Constitutional Defects in Loan Documents

Last week, the Texas Supreme Court issued a significant decision in favor of Texas home-equity lenders in Federal Home Loan Mortgage Corporation v Zepeda, No. 19-0712, answering “yes” to the following certified question from the…more

Home Equity, Home Equity Line of Credit, Lenders, Loan Documentation, Mortgages

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Survey of International Privacy Laws

Introduction - Recent years have brought a dramatic increase in the number of countries that have comprehensive privacy and data security laws. As the world has become increasingly digital, privacy and data protection have…more

Brazil, Canada, China, Cybersecurity, Data Privacy

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SCOTUS Overturns First, Fifth, Seventh, and Eleventh Circuits and Limits Scope of Computer Fraud and Abuse Act Prosecutions

In a 6-3 decision authored by the Court’s newest Justice, Amy Coney Barrett, the Court reversed and remanded Van Buren’s conviction. The majority, joined by Justices Breyer, Sotomayor, Kagan, Gorsuch, and Kavanaugh reasoned that…more

Computer Fraud and Abuse Act (CFAA), Databases, Police, SCOTUS, Unauthorized Access

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Subordinate Finance in Commercial Real Estate—The Current Landscape

Commercial real estate borrowers often need financing in amounts exceeding what traditional first mortgage lenders will provide. Profound changes in various forms of subordinate finance have occurred in the wake of the financial…more

Approval Requirements, CMBS, Commercial Real Estate Market, Equity Financing, Intercreditor Agreements

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The Restasis Patents and Tribal Sovereign Immunity: New Developments

The battle between Mylan and Allergan over the six Orange Book patents covering Restasis has taken a next formal step. On Sept. 22, the new patent-owner, the Saint Regis Mohawk Tribe, moved to dismiss Mylan’s requests for inter…more

Allergan Inc, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Mylan Pharmaceuticals, Native American Issues

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EEO-1 Deadline for 2018 Pay Data Set for September 30, 2019, Questions Remain

On April 24, 2019, the Federal Court that reinstated the EEO-1 pay data reporting requirement accepted the EEOC’s recommendation that employers must submit the EEO-1 form for 2018, including pay data, by Monday, September 30,…more

Data Collection, EEO-1, Equal Employment Opportunity Commission (EEOC), Equal Pay, Gender-Based Pay Discrimination

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New Year, New Severance and Settlement Agreement Rules for New York

With the New Year in full swing, it is important for New York employers to be aware of recent changes to New York’s statutes relating to severance agreements. On November 17, 2023, New York enacted S4516, which provides…more

Contract Terms, Employer Liability Issues, Former Employee, Hiring & Firing, Labor Reform

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The Structure of Data Rights in a Post-On-Premises World

As society moves away from the use of on-premises software into a modern world in which software vendors offer software and services through online, hosted environments, new challenges and trends related to data use and…more

Data Protection, Licensing Rules, SaaS, Software, Software Developers

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SEC Makes Moves to Step Up ESG Enforcement

As investor demand for socially responsible investing continues to rise, the U.S. Securities and Exchange Commission (SEC) has increased its focus on compliance practices of investment advisors and funds. After the change in the…more

Business Strategies, Capital Investments, Corporate Governance, Corporate Social Responsibility, Disclosure Requirements

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OIG Approves Warranty Program for Bundled Products Used in Joint Replacement Surgery

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently released Advisory Opinion 18-10, which approved a proposed arrangement involving a manufacturer of medical devices and wound care…more

Manufacturers, Medical Devices, OIG, Pharmaceutical Industry, Warranties

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Lender's Edge Newsletter: January 2018

Are Lenders Entitled to Insurance Proceeds When Foreclosing? A lender’s right to insurance proceeds after foreclosure depends on the type of loss payable clause contained in the insurance policy and the timing of the loss…more

Financial Services Industry, Foreclosure, Insurance Industry, Lenders, Mortgages

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The Chevron Doctrine: Part I

In 1984, the U.S. Supreme Court decided in Chevron U.S.A. v. Natural Resources Defense Council, Inc. (467 U.S. 837) that Federal departments and agencies can interpret federal law when the statute is unclear. Over the years,…more

Administrative Authority, Article III, Chevron Deference, Constitutional Challenges, Healthcare

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Analyzing the Proposed 2019 Stark Reforms

The United Stated Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking (NPRM) containing proposed changes to the Physician Self-Referral Law (“Stark Law,” or “Stark”) on October 17, 2019…more

Anti-Kickback Statute, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Health Care Providers, Healthcare Reform

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What’s up with Illinois’ BIPA

The Illinois Biometric Information Privacy Act, 740 ILCS 14/1 through 14/99, was enacted in 2008 to manage the promise of biometric technology for Illinois residents. BIPA seeks to encourage the development and use of biometric…more

Biometric Information, Biometric Information Privacy Act, BNSF Railway, Data Collection, Data Privacy

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Feds Two-Step on Texas Sovereignty has Far-Reaching Compliance Implications

The recent federal grand jury indictment of 21 health care executives, investors, and physicians in connection with the now defunct Dallas-based Forest Park Medical Center effectively turned the Texas health care compliance…more

Bribery, Department of Justice (DOJ), Federal Health Care Programs (FHCP), Health Care Providers, Healthcare

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Stop, Think, and Be Careful What You Ask For: Lessons and Opportunities Created by Recent Arbitration Ruling

On April 21, 2015, the Missouri Court of Appeals in City of Chesterfield v. Frederich Construction Inc. upheld an arbitration award that included substantial attorneys' fees to the prevailing party, in a construction case where…more

American Arbitration Association, American Rule, Appeals, Attorney's Fees, Construction Contracts

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Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787…more

Abbreviated New Drug Application (ANDA), America Invents Act, Generic Drugs, Hatch-Waxman, Intellectual Property Protection

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IRS Issues Long-Awaited Final Regulations for Charitable Hospitals

In This Issue: - What You Should Do - Background - Final Regulations - Hospital Facilities and Organizations - Failures to Satisfy the Requirements of Section 501(r) - Community Health…more

Affordable Care Act, Charitable Organizations, CHNA, Exempt Organizations, Final Rules

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U.S. Supreme Court Holds That The Federal Arbitration Act Preempts California’s Rule Prohibiting Contractual Arbitration of Individual PAGA Claims

On June 15, 2022, the U.S. Supreme Court issued its highly anticipated opinion in Viking River Cruises, Inc. v. Moriana, which considered whether or not claims brought under the California Private Attorneys General Act (“PAGA”)…more

Arbitration, Arbitration Agreements, California, Class Action, Class Action Arbitration Waivers

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Don't Be Left On The Sidelines: CMS Is Seeking Applications For A New Hospice Demonstration Program

Currently, Medicare patients that wish to receive palliative hospice care have a tough choice to make—forgo any curative treatment or incur all hospice care costs. This could change, however, with the recent launch of CMS's…more

Centers for Medicare & Medicaid Services (CMS), Healthcare, Healthcare Reform, Hospice, Hospitals

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What's More Appealing Than Property Taxes? Recent Kansas Legislative Changes Make This Year An Opportune Time to Appeal Yours

Do you or your company own real property in Kansas? If so, then challenging your property's tax valuation is more appealing than ever, thanks to the 2014 Kansas Legislature…more

Legislative Agendas, Property Tax, Property Valuation, State Taxes

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Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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Member of an Arizona LLC? You May Have a Fiduciary Duty to the LLC

Arizona has finally resolved the issue of whether managers and members of an Arizona Limited Liability Company (LLC) owe a common law fiduciary duty to the LLC and whether an operating agreement can lawfully limit those…more

AZ Supreme Court, Business Litigation, Common Law Torts, Contract Terms, Duty of Care

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Illinois Amends Equal Pay Act to Prohibit Questions About Salary History

Recently, Illinois amended its Equal Pay Act to include a ban on salary-history inquiries, with the stated goal of reducing gender pay inequities.  Specifically, the amendments prohibit employers from asking questions regarding…more

Amended Legislation, Employer Liability Issues, Equal Pay, Equal Pay Act, Gender Equity

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The Strategic Role of Systematic Health Care M+A in Remaking the Future of Health Care

This white paper analyzes the interplay of those middle market health care business mergers and acquisitions with the four-part, patient-care-centric conceptual framework of ownership, organization, payment and delivery that we…more

Acquisition Agreements, Business Model, Corporate Sales Transactions, Due Diligence, Health Care Providers

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Jury Sides with Hermès in Pivotal NFT Trademark Case

On February 8, 2023, a federal jury awarded Hermès International and Hermès of Paris, Inc. (“Hermès”) $133,000 in its trademark lawsuit against designer Mason Rothschild. Hermès sued Rothschild for selling non-fungible tokens…more

Artistic Works, Cybersquatting, Digital Assets, Dilution, Fashion Branding

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Vehicle Rental Laws: Road Blocks To Evolving Mobility Models?

The laws and regulations governing mobility are inconsistent and antiquated and should be modernized to encourage innovation as we prepare for an autonomous car future. The National Highway Traffic Safety Administration…more

Auto Lease, Automotive Industry, Car Rentals, Car-Sharing, Driverless Cars

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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Congressional Task Force Issues Report on Cybersecurity in the Health Care Industry

Recently, the Health Care Industry Cybersecurity Task Force (the “Task Force”) issued its Report on Improving Cybersecurity in the Health Care Industry (the “Report”). The Task Force, which was created by Congress as part of…more

Cybersecurity, Healthcare, Internet of Things, Medical Devices, NIST

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Temporary Food Labeling Policies in Light of the COVID-19 Pandemic

In the wake of the COVID-19 pandemic in the United States, the U.S. Food and Drug Administration in March relaxed its labeling requirements for food manufacturers and restaurants to aid the distribution and sale of food during…more

Agribusiness, Coronavirus/COVID-19, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Food Labeling

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Recent Regulatory Action Against an Unlicensed Insurance Administrator in Florida

The Florida Office of Insurance Regulation (“Florida OIR”) recently took regulatory action against a New York-based company (“Company”) regarding its alleged unlicensed activities in Florida. According to the Florida OIR, the…more

Certificate of Authority, Enforcement Actions, Florida, Insurance Regulations, Licensing Rules

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A Long Time Coming: DOJ Issues First FCPA Advisory Opinion in Six Years

On August 14, 2020, the Department of Justice issued a Foreign Corrupt Practices Act (“FCPA”) Advisory Opinion—the first of its kind in nearly six years. The DOJ’s opinion advised a U.S. investment company that the transaction…more

Anti-Corruption, Corporate Counsel, Department of Justice (DOJ), Enforcement Guidance, Foreign Corrupt Practices Act (FCPA)

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Group Health Plan Coverage Requirements Expanded to Include Non-Prescribed Over-the-Counter COVID-19 Testing

Effective January 15, 2022, health plans are required to cover the cost of over-the-counter (“OTC”) COVID-19 test kits obtained without a health care provider’s prescription or clinical assessment. This new requirement was…more

Compensation & Benefits, Coronavirus/COVID-19, Cost-Sharing, Employee Benefits, Employer Group Health Plans

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New Patent Office Guidance and Blockchain-based Patents

Recently, the Patent Office announced two new Guidance documents which although not targeted specifically to blockchain technology provide insight into strategies for the drafting and prosecuting of blockchain-based patents…more

Blockchain, Distributed Ledger Technology (DLT), Intellectual Property Protection, New Guidance, Patent Applications

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Cybersecurity for Startups Now a Cost of Entry for Consideration by Larger Clients: What is Your Company's Plan?

For technology startups, maintaining strong security controls remains vital to winning new business opportunities and strengthening existing relationships. Despite the global spike in cybersecurity attacks (there were 42.8…more

Cloud Computing, Cyber Attacks, Cyber Crimes, Cybersecurity, Data Breach

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CFPB Goes Public and Steps Up Enforcement Activity

The Consumer Financial Protection Bureau (CFPB) recently announced what may be its boldest move yet: a $63 million enforcement action in coordination with the Federal Trade Commission (FTC) against Minnesota-based mortgage…more

Consumer Financial Protection Bureau (CFPB), Department of Veterans Affairs, Enforcement Actions, Fair Credit Reporting Act (FCRA), Fair Housing Act (FHA)

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CMS Terminates and Scales Back Mandatory Bundled Payment Models

The Centers for Medicare & Medicaid Services (CMS) recently published a final rule that cancels the Episode Payment Models (EPMs) and the Cardiac Rehabilitation (CR) incentive payment model, each of which were slated to begin on…more

BPCI, Bundled Payments, Centers for Medicare & Medicaid Services (CMS), Episode Payment Models (EPM), Health Care Providers

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Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary…more

Affordable Care Act, Covered Entities, Drug Pricing, Health Care Providers, Healthcare

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New Legislation Overhauls State and Local Regulations for Commercial Wind and Solar Farms

On January 27, 2023, Governor Pritzker signed a bill that will transform the way counties and municipalities in Illinois locally regulate the development and construction of commercial wind and solar energy generation…more

Energy Projects, Energy Reform, Illinois, Infrastructure, New Legislation

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Biden Administration Unveils New Outbound Investment Security Program, Which Will Prohibit U.S. Investments in China Relating to Certain Technologies

On August 9, 2023, the Biden Administration took the first significant steps towards implementing a new regime to restrict and regulate U.S. investments in certain Chinese technology sectors. The President released an Executive…more

Advanced Notice of Proposed Rulemaking (ANPRM), Artificial Intelligence, Biden Administration, China, Executive Orders

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Stop, Think, and Be Careful What You Ask For: Lessons and Opportunities Created by Recent Arbitration Ruling

On April 21, 2015, the Missouri Court of Appeals in City of Chesterfield v. Frederich Construction Inc. upheld an arbitration award that included substantial attorneys' fees to the prevailing party, in a construction case where…more

American Arbitration Association, American Rule, Appeals, Attorney's Fees, Construction Contracts

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For Whom the Whistle Blows

In This Issue: - Applicability and Protected Activity - Procedure Governing Section 402 Claims - Five Steps to Compliance - For More Information - Excerpt from Applicability and Protected…more

Chief Compliance Officers, Employer Liability Issues, Federal Food Drug and Cosmetic Act (FFDCA), Food Manufacturers, FSMA

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The OIG Wants You to Know It Is Targeting Physicians - The OIG's June 2015 Fraud Alert

On June 9, 2015, the HHS Office of Inspector General (OIG) issued a Fraud Alert that cautions physicians about questionable medical directorship and office staff arrangements. [Alert available here]. In the Fraud Alert, the OIG…more

Anti-Kickback Statute, Department of Health and Human Services (HHS), Healthcare, Healthcare Fraud, Kickbacks

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Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

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Five Immediate Steps to Take in Preparation for China’s New Comprehensive Privacy Law

China has recently joined the list of countries that have adopted the world’s strictest data-privacy laws. Given China’s desirability as both a market for and a source of data, companies worldwide have started making early…more

China, Consumer Privacy Rights, Corporate Counsel, Data Privacy, Data Processors

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DCGL Amendment May Breathe New Life Into Zombie Companies

On August 1, 2023, the Delaware General Corporation Law (DGCL) was amended to create an “insolvency exception” to Delaware’s long-standing requirement that a sale of all or substantially all of a Delaware corporation’s assets…more

Board of Directors, Business Ownership, Corporate Governance, Corporate Restructuring, Delaware General Corporation Law

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Remote Patient Monitoring Opportunities and Risks for Technology Vendors and Providers

In recent years, the Centers for Medicare and Medicaid Services (CMS) has expanded coverage for remote patient monitoring (RPM) services under Medicare. RPM services include establishing, implementing, revising, and monitoring a…more

Billing, Centers for Medicare & Medicaid Services (CMS), Data Management, Data Privacy, Digital Health

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Polsinelli-TrBK Distress Indices - Third Quarter 2018

We are pleased to announce the release of the Polsinelli-TrBK Distress Indices Report for the third quarter of 2018. Polsinelli, with data provided exclusively by TrollerBk.com, publishes the Indices Report on a quarterly…more

Chapter 11, Commercial Bankruptcy, Distressed Debt, Healthcare, Real Estate Market

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Latest Update on Anthem Data Breach - Other BCBS Plans May Be Impacted

As a follow-up to its announcement of a massive cyber breach last week, Anthem has updated its “Frequently Asked Questions” for its employer clients, which are posted at www.AnthemFacts.com. The most significant development in…more

Anthem Blue Cross, Anthem Insurance, Corporate Counsel, Cybersecurity, Data Breach

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SCOTUS Rejects Defense-Friendly Scienter Standard In Schutte Opinion

On June 1, 2023, the Supreme Court of the United States (SCOTUS) issued its much-anticipated opinion in United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc. (Schutte), holding that a…more

Drug Pricing, False Claims Act (FCA), Fraud, Government Investigations, Healthcare

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What is 13th Month Pay and Why Should Employers Care?

Most American employers run payroll twelve or twenty-four times across a calendar year. In some countries, there is a “thirteenth month” to think about…more

Bonuses, Employer Responsibilities, International Labor Laws, Payroll Taxes, Salaried Employees

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Relax Jack...It’s Only a Joke!

Jack Daniel’s Properties, Inc. v. VIP Products LLC. (Docket 22-148) On March 22, 2023, VIP Products LLC told the Supreme Court that its parody Bad Spaniels whiskey-bottle-shaped dog toys do not violate the Lanham Act…more

First Amendment, Free Speech, Intellectual Property Protection, Jack Daniels Properties Inc v VIP Products LLC, Lanham Act

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American Rescue Plan Brings $86 Billion in Relief to Failing Multiemployer Pension Plans

The American Rescue Plan that was sent to President Biden’s desk on March 11, 2021 includes an $86 Billion aid package that provides financial assistance to underfunded multiemployer pension plans facing critical or declining…more

Biden Administration, Compensation & Benefits, Employee Benefits, Legislative Agendas, Multiemployer Plan

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Federal Banking Regulators Issue New Guidance for Complying with 36 Hour Cybersecurity Incident Reporting Requirement

On March 29, 2022, federal banking regulators issued important guidance for how banking organizations can comply with the upcoming requirement to notify regulators within 36 hours of ransomware or other disruptive cybersecurity…more

Banking Regulators, Cyber Attacks, Cyber Incident Reporting, Cybersecurity, Data Breach

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How FinTech Could Reboot LIBOR

Part One of this two part E-alert looked at the challenges facing London Inter-Bank Offered Rate (LIBOR) LIBOR and how the syndicated loan market is dealing with the potential non-availability of these rates. Part two considers…more

Benchmarks, Blockchain, Distributed Ledger Technology (DLT), Financial Transactions, FinTech

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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New Independent Contractor Test Increases Risk of Independent Contractor Misclassification

The U.S. Department of Labor is set to issue a Proposed Rule that will have a significant impact on the test used to determine whether someone is an independent contractor or an employee under the Fair Labor Standards Act…more

Biden Administration, Department of Labor (DOL), Employee Definition, Employer Liability Issues, Fair Labor Standards Act (FLSA)

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Fireworks Are Coming Before Independence Day

Mark your calendars for July 3—the date we will likely learn whether a Texas Court will enjoin the FTC Rule banning non-competes from taking effect on September 4. This week, Judge Ada Brown, the presiding judge in Ryan, LLC v…more

Competition, Confidential Information, Employer Liability Issues, Employment Contract, Federal Labor Laws

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2019 Colorado Bills to Watch

Colorado’s 2019 legislative session began on January 4 and concludes May 3, 2019.  Several proposed bills may affect employers, including these two..…more

Ban the Box, Criminal Background Checks, Employer Liability Issues, Equal Pay, Gender-Based Pay Discrimination

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Catching Judge Sontchi’s “Flurry of Opinions” PARTS 2-3 OF 3

In This Issue: - In re: Energy Future Holdings Corp., et al, 14-10979 (CSS) (CSC Trust Company of Delaware, as Indenture Trustee, v. Energy Future Intermediate Holdings Company LLC and EFIH Finance, Inc., Adv. Pro No:…more

Chapter 11, Commercial Bankruptcy, Debt, Debtors, Indenture Trustee

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SEC Proposes Significant Alterations for Financial Obligation Disclosures for Governmental Issuers and Certain Nonprofit Organizations

The Securities and Exchange Commission (the "SEC") recently sent a clear message to participants in the municipal markets: it intends to require a greater level of disclosure, and more timely disclosure, regarding an obligated…more

Comment Period, Default, Disclosure Requirements, Municipal Securities Market, Proposed Amendments

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Reopening Hospital Service Lines: A Playbook for Moving Forward

The COVID-19 pandemic has created severe financial and operational difficulties for hospitals. Rapidly responding to a novel pathogen within a declared Public Health Emergency (PHE), while experiencing decreased revenues as a…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Responsibilities, Re-Opening Guidelines, Return-to-Work Agreements

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Courts Split on How to Determine Statutory Damages for Copyright Infringement

The recent decision in Energy Intelligence Group, Inc. v. CHS McPherson Refinery, Inc. highlights a circuit split regarding how courts determine the statutory damages available for copyright infringement where multiple…more

Copyright, Copyright Infringement, Copyright Litigation, Intellectual Property Protection, Loss in Economic Value

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Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

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Texas Offers State Low-Income Housing Tax Credits

Texas Governor Greg Abbott (R) recently signed Texas House Bill (H.B.) 1058, making Texas at least the 28th state, plus the District of Columbia, to offer state low-income housing tax credits to bridge the growing affordable…more

Affordable Housing, Community Development, Construction Project, Critical Infrastructure Sectors, LIHTC

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California Privacy Rights Act: Latest Update, Impact and Next Steps

The California Privacy Rights Act (CPRA) is a ballot initiative that, if passed in November, will significantly amend the California Consumer Privacy Act (CCPA)…more

B2B Transactions, Ballot Measures, Behavioral Advertising, California Consumer Privacy Act (CCPA), California Privacy Rights Act (CPRA)

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Privacy Update: Complying With COPPA Under The FTC's New Children's Online Privacy Protection Rules

In December 2012, the Federal Trade Commission (FTC) issued updated rules to the Child's Online Privacy Protection Act (COPPA), which significantly expand COPPA's scope and application. COPPA, which governs the collection, use,…more

COPPA, Data Collection, Data Protection, Federal Trade Commission (FTC), Internet Service Providers (ISPs)

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Recent Enforcement Action: Business Associates Not Off the Hook

Despite the fact that Business Associates have been directly subject to and liable under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (HIPAA) since February 18, 2010 the…more

Business Associates, Data Breach, Health Care Providers, Health Insurance Portability and Accountability Act (HIPAA), HIPAA Audits

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2020 Medicare Physician Fee Schedule - Reimbursement and Payment Policy Proposals

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) released the FY 2020 Medicare Physician Fee Schedule (MPFS) proposed rule [CMS-1715-P] (Proposed Rule). A link to the full rule is available here. Stakeholder…more

Health Care Providers, Medical Reimbursement, Medicare, Physician Fee Schedule, Physician Payments

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Stark Law: What Providers Should Know About New CMS Form

The Centers for Medicare and Medicaid Services (CMS) has finalized Form CMS-10328 (the SRDP Form), a new OMB-approved information collection instrument that must be used by providers and suppliers utilizing the Stark Law…more

Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), False Claims Act (FCA), Health Care Providers, OIG

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Is the NLRB Returning to the Traditional Interpretation of Spruce-up?

When purchasing a business, the buyer often desires to set new terms of employment to more efficiently and profitably operate the new enterprise…more

Bargaining Units, Buying a Business, Contract Negotiations, Employee Retention, Employer Liability Issues

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Lance Armstrong Becomes Cautionary Tale on Risks of Arbitration

Arbitration is sometimes touted as less expensive and less risky for businesses than traditional courtroom litigation, especially when it comes to consumer disputes. But disgraced cyclist Lance Armstrong's most recent legal loss…more

Arbitration, Lance Armstrong

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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Uncle Sam Wants to Protect Blockchain Technology

On August 27, 2020, the head of the U.S. Department of Justice’s Antitrust Division (“DOJ”), Makan Delrahim, spoke at the Thirteenth Annual Conference on Innovation Economics and emphasized that one of the DOJ’s top priorities…more

Anti-Competitive, Antitrust Division, Antitrust Provisions, Blockchain, Critical Infrastructure Sectors

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Federal Agencies Release a Final Rule Implementing the No Surprises Act’s Independent Dispute Resolution Process

On August 19, 2022, three federal agencies tasked with adopting regulations for the No Surprises Act (“NSA”) issued a highly anticipated Final Rule implementing key aspects of the NSA’s independent dispute resolution (“IDR”)…more

Biden Administration, Billing, Dispute Resolution, Final Rules, Health Care Providers

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Health Care “Prime” The Shaping of Health Care in America Through M+A and Innovation

This is a notable period for the modern health care industry in America. The health care ecosystem is evolving at an accelerating pace. How health care is owned, organized, delivered and paid for in the future will be different…more

Acquisitions, Analytics, Health Care Providers, Health Insurance, Healthcare Reform

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IRS Issues Long-Awaited Final Regulations for Charitable Hospitals

In This Issue: - What You Should Do - Background - Final Regulations - Hospital Facilities and Organizations - Failures to Satisfy the Requirements of Section 501(r) - Community Health…more

Affordable Care Act, Charitable Organizations, CHNA, Exempt Organizations, Final Rules

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Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's…more

Amgen, Biologics, Biologics Price Competition and Innovation Act of 2009, Biosimilars, BPCIA

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Securities and Exchange Commission Modernizes Disclosure Requirements For Financial Institutions

On September 11, 2020, the Securities and Exchange Commission (the “SEC”) adopted final rules applicable to banks, bank holding companies, savings and loan associations and savings and loan holding companies that will, among…more

Corporate Governance, Disclosure Requirements, Financial Institutions, Financial Statements, GAAP

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Proposed Rule Expands Scope Of Waters Covered By Clean Water Act

On March 25, 2014, the U.S. Environmental Protection Agency and U.S. Army Corps of Engineers jointly proposed a new rule to clarify the scope of waters subject to the Clean Water Act. The proposed rule redefines the meaning of…more

Clean Water Act, Environmental Protection Agency (EPA), Jurisdiction, Public Comment, Rulemaking Process

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Illinois Announces Extension of Stay at Home Order and Phased Reopening of State, Including Authorizing Health Care Facilities to Resume Elective Procedures

On April 23, 2020, Illinois Governor JB Pritzker announced during his daily press conference that he would issue an executive order next week extending Illinois’ stay at home order through May 30, 2020…more

Coronavirus/COVID-19, Critical Infrastructure Sectors, Executive Orders, Personal Protective Equipment, Shelter-In-Place

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Missouri Protects Health Care Providers from Civil Actions Relating to COVID-19 Exposure

On July 7, 2021, Missouri Governor Mike Parson signed SB 51 into law, which protects health care providers from being held liable in civil actions for COVID-19 exposure (the “Act”)…more

Civil Liability, Coronavirus/COVID-19, Health Care Providers, Immunity, Infectious Diseases

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Can You Discriminate Against a Company's Race? Fourth Circuit Says Yes, Grants Standing to Sue for Racial Discrimination

Owners, contractors and other recipients of federal funds be aware: when construction or other federally-funded contracts sour, not only can contracting parties file lawsuits claiming breach of contract, but if the contracting…more

Construction Industry, Discrimination, Federal Contractors, Minority-Owned Businesses, Public Financing

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SEC Division of Examinations Announces 2022 Examination Priorities

Each year, the U.S. Securities and Exchange Commission’s (SEC) Division of Examinations (Division) prioritizes the examination of certain practices, products and services that it believes present potentially heightened risks to…more

Anti-Money Laundering, Capital Formation, Capital Markets, Investor Protection, Regulatory Agenda

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Senate Leaders Propose Significant Changes to the EB-5 Program: Big City Developers Are Likely to Rejoice

On November 5, 2019, Senators Rounds (R-SD), Graham (R-SC) and Cornyn (R-TX) introduced the Immigrant Investor Program Relief Act (S. 2778) (“Relief Act”). The Relief Act would extend the Immigrant Investor Program (known as…more

EB-5, Economic Development, Foreign Investment, Hiring & Firing, I-526 Petition

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Here We Grow Again: Discover the legal issues fast-growing businesses confront.

Fast-growing businesses often encounter unique and accelerated business-related issues, such as a shortage of capital and human resources, due to their rapid expansion. Proactively dealing with the legal ramifications of these…more

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Health Care Reimbursement and Payor Dispute Update - September 2022

Co-Location and the Provider-Based Rules – No News is…Good News? On July 15, the Centers for Medicare & Medicaid Services ("CMS") released the 2023 Outpatient Prospective Payment System proposed rule (“OPPS Proposed Rule”),…more

Centers for Medicare & Medicaid Services (CMS), Critical Access Hospitals, Health Care Providers, Health Insurance, Healthcare

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Federal Reserve Announces New Details for Term Asset-Backed Securities Loan Facility (TALF)

On March 23 the Federal Reserve announced the creation of the Term Asset-Backed Securities Loan Facility, or TALF to support the asset-backed securities (ABS) market.  The new facility (commonly referred to in the market as TALF…more

Asset-Backed Securities, CMBS, Collateral, Collateralized Loan Obligations, Federal Reserve

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Critical Infrastructure Cybersecurity – Evolving Incident Response Obligations, Integral to Effective Risk Management

Just over a year ago, the White House issued its long-awaited National Cybersecurity Strategy, with an emphasis on defending Critical Infrastructure, promoting public and private collaboration, and safeguarding…more

Critical Infrastructure Sectors, Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA), Cyber Threats, Cybersecurity, Data Protection

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The Corporate Transparency Act and Pandora’s Papers

With the recent release of the “Pandora Papers,” renewed attention is focused on corporate ownership transparency. Earlier this year, Congress passed the Corporate Transparency Act (“CTA”). The CTA was enacted to combat the use…more

Corporate Transparency Act, Financial Fraud, FinCEN, International Consortium of Investigative Journalists (ICIJ), Money Laundering

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Congress Clears Major Agreement to Avert Debt Default

Deal Includes Significant New Regulatory Provisions - Days ahead of the Treasury Department’s projected default date, the U.S. House and Senate cleared a bipartisan package to raise the debt ceiling, extend the country’s…more

Biden Administration, Debt Ceiling, Federal Budget, Global Market, Government Shutdown

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eBay Lawsuit Dismissed

On May 4, 2015, a US District Court judge in the Eastern District of Louisiana dismissed a class action lawsuit that sought damages from eBay based on the “threat of future harm” stemming from the online retailer’s 2014 data…more

Article III, Clapper v. Amnesty International, Class Action, Cyber Attacks, Cybersecurity

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The European Union Has Assigned Your AI Some Homework

Seeking to build on the success and influence of GDPR, the European Union has spent the last seven years constructing a comprehensive regulatory scheme for artificial intelligence: The Artificial Intelligence Act (AI Act)…more

AI Act, Artificial Intelligence, Automation Systems, Cybersecurity, Innovative Technology

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The Structure of Data Rights in a Post-On-Premises World

As society moves away from the use of on-premises software into a modern world in which software vendors offer software and services through online, hosted environments, new challenges and trends related to data use and…more

Data Protection, Licensing Rules, SaaS, Software, Software Developers

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Relax Jack...It’s Only a Joke!

Jack Daniel’s Properties, Inc. v. VIP Products LLC. (Docket 22-148) On March 22, 2023, VIP Products LLC told the Supreme Court that its parody Bad Spaniels whiskey-bottle-shaped dog toys do not violate the Lanham Act…more

First Amendment, Free Speech, Intellectual Property Protection, Jack Daniels Properties Inc v VIP Products LLC, Lanham Act

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American Health Care Act in the U.S. House of Representatives

On January 13th, Congress passed the Fiscal Year 2017 Budget Resolution (S. Con. Res. 3) which included reconciliation instructions for the House Committees on Energy and Commerce and Ways and Means and the Senate Committees on…more

Affordable Care Act, Cadillac Tax, Congressional Budget Office, Employer Mandates, Health Insurance

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SEC Adopts Cybersecurity Incident and Risk Management Disclosure Rules

On July 26, 2023, the Securities and Exchange Commission (the “SEC”) adopted new rules requiring public companies to disclose within four business days material cybersecurity incidents they experience and to disclose annually…more

Cyber Attacks, Cybersecurity, Data Breach, Data Protection, Data Security

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The Strategic Role of Systematic Health Care M+A in Remaking the Future of Health Care

This white paper analyzes the interplay of those middle market health care business mergers and acquisitions with the four-part, patient-care-centric conceptual framework of ownership, organization, payment and delivery that we…more

Acquisition Agreements, Business Model, Corporate Sales Transactions, Due Diligence, Health Care Providers

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FTC Final Rule Banning Most Non-Competes Passes – What Nonprofits Need to Know

On April 23, 2024, the Federal Trade Commission (“FTC”) conducted a special Open Commission Meeting to vote on a Final Rule (the “Rule”) banning most non-compete clauses as an “unfair method of competition.” By a vote of 3-2,…more

501(c)(3), Competition, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC)

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Leaked Draft Rule Increases Federal Power Over Private Lands

Federal control over private lands would be expanded significantly under a proposed rule reportedly drafted by the Environmental Protection Agency ("EPA") and the U.S. Army Corps of Engineers ("Corps"). Industry groups…more

Environmental Protection Agency (EPA), Excavation, Private Property, US Army Corps of Engineers

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Finding the Time: SEC Announces Deadline Extension for MCDC Initiative

Since 1995, the SEC’s Rule 15c-12 has, subject to a few exceptions, required the “post issuance” delivery of certain annual financial and operating information from parties that are obligated to provide for the repayment of…more

Deadlines, Disclosure Requirements, MCDC, Municipal Bonds, Securities and Exchange Commission (SEC)

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Utah Passes Innovative DAO Legislation

On March 1, 2023, the Utah Legislature passed HB 357, the “Utah Decentralized Autonomous Organizations” Act (the “Utah DAO Act”). This was a combined effort of the Utah Legislature’s Blockchain and Digital Innovation Task Force,…more

Blockchain, Business Formation, Decentralized Autonomous Organization (DAO), Digital Assets, Innovative Technology

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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Proposed Regulatory Changes to Safe Harbor Warning Provisions

All consumer products and food products sold or distributed into the State of California may soon be subject to new scrutiny for chemical exposure warnings Revisions to a critical environmental law regarding warnings for…more

OEHHA, Product Labels, Proposition 65, Regulatory Agenda, Safe Harbors

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SEC Adopts Amendments to MD&A and Other Financial Disclosure Requirements in Regulation S-K

On November 19, 2020, the Securities and Exchange Commission (the “SEC”) adopted final rule amendments to modernize, simplify, and enhance Management’s Discussion & Analysis of Financial Condition and Results of Operations…more

Corporate Governance, Disclosure Requirements, Financial Regulatory Reform, Financial Statements, MD&A Statements

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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Regeneron v Novartis and Vetter: Walker Process Client Update

In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in the…more

Antitrust Provisions, Biologics, Department of Justice (DOJ), Federal Rule 12(b)(6), Federal Trade Commission (FTC)

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Treasury Notice on Inversions Leaves Basic Inversion Transactions Intact

In This Issue: - Deferred Earnings and Profits of CFCs - Code Section 956(e) - Code Section 7701(l) - Code Section 304(b)(5)(B) - Code Section 7874 - Request for Comments - For…more

CFCs, Corporate Taxes, Inversion, Tax Evasion, U.S. Treasury

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Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

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SEC Proposes Changes to Modernize and Simplify Equity Compensation Rules and Registration Obligations

On November 24, 2020, the Securities and Exchange Commission (“SEC”) proposed amendments to Rule 701 and Form S-8 (the “Proposals”) under the Securities Act of 1933, as amended (the “Securities Act”)…more

Disclosure Requirements, Form S-8, Publicly-Traded Companies, Rule 701, Securities and Exchange Commission (SEC)

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Illinois Rolls Out a 5-Phase Reopening Plan as Health Care Facilities Prepare to Resume Elective Surgeries

On May 5, 2020, Illinois Governor J.B. Pritzker unveiled “Restore Illinois,” a 5-phase public health plan to reopen Illinois. The plan endeavors to best support Illinoisans’ health and health care systems and save the most…more

Coronavirus/COVID-19, Critical Infrastructure Sectors, Health Care Providers, Healthcare Facilities, Re-Opening Guidelines

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California Pay Data Reporting Update

As we previously reported, on September 27, 2022, Governor Gavin Newsom approved SB 1162 to significantly expand the pay data reporting and pay scale requirements for California employers. These requirements became effective…more

California, Employer Liability Issues, Labor Reform, New Legislation, Pay Data

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Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare…more

Centers for Medicare & Medicaid Services (CMS), Cramdown, Drug Pricing, Health Care Providers, Healthcare Reform

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Prop 15 is Ready to Rock Commercial Properties with the Split-Roll

On November 3, 2020, California voters will decide on Proposition 15, the citizen-initiated proposition that seeks to create a split-roll tax system in California. Also known as “The California Schools and Local Communities…more

Ballot Measures, Property Owners, Property Tax, Property Valuation, Real Estate Market

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U.S. Federal Privacy Bill Unveiled

On April 5, 2024 members of U.S. Congress released a draft bipartisan, bicameral federal privacy bill, the American Privacy Rights Act. In a press release, the stated goal of this legislation is to be “a national data privacy…more

Consumer Privacy Rights, Data Brokers, Data Management, Data Privacy, Data Processors

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Breaking: Supreme Court Rules on Appellate Review Standard for Patent Claim Construction

Today, in Teva Pharmaceutical USA, Inc., et al. v. Sandoz, Inc. et al., the Supreme Court issued a long-awaited opinion that changes the standard of appellate review for a trial court's decision regarding construction of a…more

Claim Construction, Clear Error Standard, De Novo Standard of Review, Federal Rules of Civil Procedure, Patent Litigation

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October PFAS Regulatory Update

In October 2023, the United States Environmental Protection Agency (EPA) finalized two separate but analogous rulemakings – one under the Toxic Substances Control Act (TSCA), and one under the Emergency Planning and Community…more

Contamination, Drinking Water, Environmental Policies, EPCRA, Hazardous Substances

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The European Union Has Assigned Your AI Some Homework

Seeking to build on the success and influence of GDPR, the European Union has spent the last seven years constructing a comprehensive regulatory scheme for artificial intelligence: The Artificial Intelligence Act (AI Act)…more

AI Act, Artificial Intelligence, Automation Systems, Cybersecurity, Innovative Technology

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New Ripples in TCPA Law

Telephone Consumer Protection Act (“TCPA”) litigation is on the rise. Given the TCPA’s significant penalties of $500-$1500 per call, text or facsimile, the potential for firm-changing liability is a real threat…more

ATDS, Auto-Dialed Calls, Corporate Counsel, FCC, Prior Express Consent

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Recent Regulatory Action Against an Unlicensed Insurance Administrator in Florida

The Florida Office of Insurance Regulation (“Florida OIR”) recently took regulatory action against a New York-based company (“Company”) regarding its alleged unlicensed activities in Florida. According to the Florida OIR, the…more

Certificate of Authority, Enforcement Actions, Florida, Insurance Regulations, Licensing Rules

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California’s AB 3129 Continues National Trend of Scrutinizing Private Equity Investments in the Health Care Industry

The California legislature is considering a bill that could severely impact the ability for private equity companies and hedge funds to operate in the California health care industry. AB 3129, introduced by Assembly Member Jim…more

Acquisition Agreements, California, Healthcare, Hedge Funds, Investment

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HHS Finalizes Appeals Backlog Rule in Wake of Judicial Order

The U.S. Department of Health and Human Services (HHS) released a Final Rule aimed at reducing and eventually eliminating the backlog of more than 650,000 claims currently awaiting adjudication by an administrative law judge…more

Adjudicatory Process, Administrative Law Judge (ALJ), Amount in Controversy, Centers for Medicare & Medicaid Services (CMS), Decision-Making Process

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Employee Retention Tax Credits Update: IRS Warns Taxpayers to Beware

On October 19, 2022, the Internal Revenue Service (“Service”) issued news release IR-2022-183, which was intended to warn employers using third-party promoters of Employee Retention Tax Credits (“ERTCs”).  ERTCs were created by…more

CARES Act, Coronavirus/COVID-19, Corporate Counsel, Employee Retention, Internal Revenue Code (IRC)

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Med-Staff Newsletter - February 2023 | VOL 11

Structure of AMCs - While every AMC is unique, there are some common characteristics that many share: (1) the hospital and school are often tethered together from an organizational, governance and/or legal perspective; (2)…more

Accreditation, Coronavirus/COVID-19, Credentialing, Health Care Providers, Healthcare

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Finally Final — The DOL Issues Its Long-Expected Final Rule Raising the FLSA Overtime Exemption Salary Thresholds

As has been expected, and as we addressed at the end of 2023 in our previous blog post, on April 23, the U.S. Department of Labor (“DOL”) at long last issued its final rule raising the salary thresholds for overtime exemptions…more

Department of Labor (DOL), Employer Liability Issues, Exempt-Employees, Fair Labor Standards Act (FLSA), Federal Labor Laws

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ACGME is Instituting New Mandatory Medical, Parental and Caregiver Leave Requirements for Residency and Fellowship Programs: Are You Ready?

Organizations overseeing physician training (like ABMS and ACGME) have recently demonstrated a renewed commitment to supporting physicians’ holistic development by adopting new mandatory leave requirements for…more

Employee Training, Forced Leave of Absences, Healthcare, Physicians, Policies and Procedures

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OFCCP Breaks Record With Over $40M in Settlements in 2019

The Office of Federal Contractor Compliance has been busy this year.  In 2019, it has obtained over $40M in settlements from federal contractors to resolve claims of hiring and compensation discrimination.  This figure tops the…more

Affirmative Action, Employment Discrimination, Enforcement Actions, Equal Pay, Federal Contractors

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Impact of New Tax Laws on Estate Planning

The Tax Cuts and Jobs Act of 2017 (the “Act”) was signed into law by the President on December 22, 2017, and represents one of the most significant rewritings of the federal tax code since 1986…more

529 Plans, Estate Planning, Estate Tax, Generation-Skipping Transfer, Gift Tax

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The Approaching School Year Brings Renewed Focus on Workplace Policies

While elected-officials determine the feasibility of reopening America’s classrooms and workplaces, there is little certainty as to what life will look like in the fall for employers and employees alike. Will students be in…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Responsibilities, Families First Coronavirus Response Act (FFCRA), Re-Opening Guidelines

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Third Party Administrator Update - TPA Licensing and Compliance: Vermont Issues Proposed Regulation Adopting DECEMBER 2020 Licensing and Regulatory Requirements for TPAs

In the fall of 2019, we reported that Vermont enacted Senate Bill 41, which granted the Commissioner of the Vermont Department of Financial Regulation (the “Department”) jurisdiction over entities that administer one or more…more

Employee Benefits, Flexible Spending Accounts, Health Insurance, Health Savings Accounts, TPAs

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Catching Up With the Times: CMS Reforms Long-Term Care Facility Requirements - Part I

On Oct. 4, CMS published the biggest overhaul to federal long-term care regulations since 1991. The lengthy Final Rule reforms the requirements for long-term care facilities participating in Medicare and Medicaid. CMS…more

Arbitration, Arbitration Agreements, Binding Arbitration, Centers for Medicare & Medicaid Services (CMS), Contract Terms

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Unsigned And Out Of Luck

In keeping with Missouri courts' increasingly narrow view of enforcing arbitration agreements in the employment arena, the Missouri Court of Appeals in Baier v. Darden Restaurants yesterday upheld the trial court's decision…more

Arbitration, Arbitration Agreements, Signatures

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Delaware Court of Chancery Establishes Duty of Oversight Extends to Officers

In a significant and far-reaching development in Delaware corporate law, the Delaware Court of Chancery recently held in In re McDonald’s Corporation Stockholder Derivative Litigation, C.A. No. 2021-0324-JTL (Del. Ch. Jan. 25,…more

Board of Directors, Breach of Duty, Caremark claim, Corporate Culture, Corporate Officers

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With Prejudice: Judge Dismisses FCA Claim and Orders Sanctions Against Attorney

On October 16, 2014, United States Magistrate Judge Jeremiah McCarthy of the Western District of New York issued a Report and Recommendation to District Judge William Skretny in which he recommended dismissal with prejudice as a…more

Attorney Misconduct, False Claims Act (FCA), Rule 11, Sanctions, Whistleblowers

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Rhode Island State LIHTC: Another Step Towards Affordable Housing

Rhode Island joins 26 other states in offering state low-income housing tax credits to bridge the growing affordable housing gap in the United States. Rhode Island Governor Daniel McKee recently signed the FY24 RI Ready…more

Affordable Housing, Community Development, Construction Project, Financing, LIHTC

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Med-Staff Newsletter - August 2022 | VOL 10

Whether you are new to medical staff leadership or have served in the past and have been called to serve again, there are times when you will need to consult a lawyer who specializes in medical staff matters. While there is…more

Abortion, ADEA, Coronavirus/COVID-19, Dobbs v. Jackson Women’s Health Organization, Employer Liability Issues

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IRS And Treasury Releases 2013-2014 Priority Guidance Plan

The Department of the Treasury and the IRS, on August 9, issued their 2013-2014 Priority Guidance Plan. This plan entails 324 tax law projects that are priorities for the allocation of the government's tax law administrative…more

Exempt Organizations, Internal Revenue Code (IRC), IRS, Priority Guidance Plan, Tax Exemptions

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Is your Company in Compliance with the New Warning Regulations under California’s Proposition 65?

All consumer products sold or distributed into the State of California may be subject to new chemical warning regulations that go into effect in three months…more

Manufacturers, OEHHA, Proposition 65, Regulatory Oversight, Regulatory Requirements

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What is the Impact of the FTC’s Final Non-Compete Rule on Franchisors and Franchisees?

As explained in Polsinelli’s prior alert of April 24, 2024, the FTC announced its final rule on non-compete covenants (the “Rule”) on April 23, 2024. Critically, the Rule does not prohibit non-compete agreements between…more

Competition, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC), Franchisee

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Cybersecurity Awareness Means, at a Minimum, Doing the Basics (Again and Again)

On September 30, 2022, the White House kicked off Cybersecurity Awareness Month by reminding citizens of the impacts cyberattacks can have on critical infrastructure such as “electric grids and fuel pipelines … and many other…more

Critical Infrastructure Sectors, Cyber Attacks, Cyber Threats, Cybersecurity, Data Management

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“No Concrete Harm, No Standing” – Supreme Court Finds Class Members Who Were Not Personally Harmed by Statutory Violations Lack Article III Standing

On June 25, 2021, the Supreme Court issued a landmark decision in TransUnion v. Ramirez. The Court ruled that class members whose inaccurate credit reports were not shared with third parties lacked standing to sue TransUnion for…more

Article III, Class Action, Class Members, Credit Reporting Agencies, Credit Reports

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10 Steps to Better Managing Mass Tort Litigation

From the now decades old asbestos litigation to pharmaceuticals and product liability cases to the newly developing PFAS or “forever chemical” lawsuits, mass tort litigation has increasingly become the tool of choice by which…more

Access to Legal Counsel, Class Action, Client Services, Commercial Litigation, Corporate Liability

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On the Brink(er): In Appeal of Closely-Watched Data Breach Class Certification, Eleventh Circuit Vacates in Part and Remands for Further Proceedings

The Eleventh Circuit’s recent ruling in In re Brinker Data Incident Litigation (“Brinker”) is the first time that a federal circuit court has ruled on a lower court’s grant of class certification in a data breach class action…more

Article III, Class Action, Class Certification, Cyber Attacks, Data Breach

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Strategic Growth: Is a Merger of Equals Right for Your Organization?

In today’s complex regulatory and business environment, many community banks are considering either growing through acquisition or selling to a larger institution. As an alternative to these transactions, we are seeing an…more

Banks, C-Corporation, IRS, Mergers, S-Corporation

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Will a New Wave of Lawsuits Roll Into a Nationwide Tsunami? Wiretapping Litigation for Website Analytics

2022 has seen a new wave of class action lawsuits targeting companies that use technology to track consumers’ interfaces on their websites. These lawsuits generally allege that the use of technologies such as session replay…more

Bots, Data Collection, Data Privacy, Electronic Communications, Electronic Monitoring

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Critical Infrastructure Cybersecurity – Evolving Incident Response Obligations, Integral to Effective Risk Management

Just over a year ago, the White House issued its long-awaited National Cybersecurity Strategy, with an emphasis on defending Critical Infrastructure, promoting public and private collaboration, and safeguarding…more

Critical Infrastructure Sectors, Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA), Cyber Threats, Cybersecurity, Data Protection

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Med-Staff Newsletter - February 2023 | VOL 11

Structure of AMCs - While every AMC is unique, there are some common characteristics that many share: (1) the hospital and school are often tethered together from an organizational, governance and/or legal perspective; (2)…more

Accreditation, Coronavirus/COVID-19, Credentialing, Health Care Providers, Healthcare

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Missouri Appellate Court Explores Legal Remedies after Failed Business Purchase, Joins the Trend of State Court Exploring the Contours of Declaratory Judgments, Law and Equity

A recent court case from Missouri’s Eastern District Court of Appeals provides insight on the intersection of declaratory judgments, legal damages, and equitable relief, particularly in disputes over complicated business…more

Appeals, Breach of Contract, Business Litigation, Contract Disputes, Contract Terms

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Top Immigration Updates for U.S. Employers during COVID-19 National Emergency

The COVID-19 National Emergency has brought a host of challenges to employers in the United States, including travel, compliance with employment verification processes, and hiring and maintaining immigration status for foreign…more

Canada, Coronavirus/COVID-19, Department of Labor (DOL), Employment Eligibility Verification, Foreign Nationals

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California Pay Data Reporting Update

As we previously reported, on September 27, 2022, Governor Gavin Newsom approved SB 1162 to significantly expand the pay data reporting and pay scale requirements for California employers. These requirements became effective…more

California, Employer Liability Issues, Labor Reform, New Legislation, Pay Data

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The NLRB Throws A Flag On The Northwestern Football Program

In a much awaited decision, the Regional Director for Region 13 of the National Labor Relations Board ("NLRB") has determined that grant-in-aid scholarship recipients on the Northwestern University football team are more than…more

College Athletes, NLRB, Unions

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Patient-Centered Sustainable Health Care

I. INTRODUCTION - Over the past two years, global events reshaped the health care industry by shifting the priorities of the industry’s key stakeholders. In the post-Covid-19 economy, quick responses to short-term problems…more

Healthcare, Healthcare Reform, Hospital Mergers, Patient-Specific, Patients

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Opportunity Zone Deadlines Extended By COVID-19 Disaster Declarations (UPDATED)

On January 19, 2021, the IRS published guidance in Notice 2021-10, extending critical deadlines and rules relating to investments in qualified opportunity zones. First, any investors facing a deadline between April 1, 2020, and…more

Capital Gains, Community Development, Coronavirus/COVID-19, Economic Development, Infectious Diseases

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Design Patent vs. Trade Dress: Strategic Considerations for Protecting Product Designs

Product designs often serve as the cornerstone of a brand’s identity, evoking instant recognition and loyalty among consumers. From the iconic silhouette of Coca-Cola’s glass bottle to the distinctive shape of Gibson guitars,…more

Acquired Distinctiveness, Consumer Product Companies, Corporate Branding, Design Patent, Intellectual Property Protection

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What is the Impact of the FTC’s Final Non-Compete Rule on Franchisors and Franchisees?

As explained in Polsinelli’s prior alert of April 24, 2024, the FTC announced its final rule on non-compete covenants (the “Rule”) on April 23, 2024. Critically, the Rule does not prohibit non-compete agreements between…more

Competition, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC), Franchisee

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Reimbursement and Payor Dispute Update -Federal Cases Offer Medicare-Enrolled Providers Possible Injunctive Relief from Recoupments While Awaiting Administrative Appeal

Polsinelli is pleased to share the Health Care Reimbursement and Payor Dispute Update. This newsletter is a designated source of news, information and guidance on the constantly evolving reimbursement industry. …more

Administrative Appeals, Centers for Medicare & Medicaid Services (CMS), Contract Disputes, Enrollment, Health Care Providers

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Blockchain+ Bi-Weekly - May 2024

Big news dropped in the past few weeks, which sent shockwaves across the industry: according to a recently filed lawsuit, the SEC has classified the second largest cryptocurrency, Ether, as a security in certain ongoing…more

Blockchain, Cryptocurrency, Digital Assets, Digital Wallets, Investment Opportunities

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Cuts In Services May Leave Bigger Wounds

In a recent open letter, the Illinois Department of Financial and Professional Regulation (the "Department") advised providers of cuts in the Department's Medical Unit that will negatively impact the state's healthcare…more

Budget Cuts, Healthcare, Licenses, Physicians

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Medicare Continues its Updates to Provider Enrollment Policies as Part of Efforts to Enhance Program Integrity and Transparency

The Centers for Medicare & Medicaid Services (“CMS”) continued its efforts to increase oversight of the Medicare program by updating Medicare provider enrollment regulations and policies through recent regulatory and…more

Centers for Medicare & Medicaid Services (CMS), Enrollment, Health Care Providers, Health Insurance, Healthcare

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Four Security Gaps Cybercriminals Exploit in Your Business's Digital Storefront

Symantec, the American IT security company, recently released its 2015 Internet Security Threat Report that summarizes the number and types of threats and vulnerabilities seen in 2014. The report also analyzes trends and…more

Best Practices, Cybersecurity, Data Breach, Data Protection, Internet Retailers

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Do You Export to China, Russia, or Venezuela? Take Notice of New and Expanded BIS Rules

The U.S. Department of Commerce, Bureau of Industry and Security (BIS) released impactful new rules on April 28, 2020, that significantly heighten controls on exports to China, Russia, and Venezuela under the Export…more

Bureau of Industry and Security (BIS), China, Electronic Export Information (EEI), Export Administration Regulations (EAR), Export Controls

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Reopening the Economy and Getting Back to Business: Will Liability Waivers Protect My Business?

Last week, in our blog post entitled Reopening the Economy and Getting Back to Business: Business Owners’ Liability Risk When Dealing with Customers and Others, we talked about the various considerations and risk mitigation…more

Coronavirus/COVID-19, Liability, Negligence, Waivers

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Making Sense of the MACRA Final Rule – Part 3 of 3: Merit Based Payment Incentive System (MIPS)

The Centers for Medicare & Medicaid Services (CMS) recently released its final rule with comment period implementing the bipartisan Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Among its numerous changes, MACRA…more

Alternative Payment Models (APM), CEHRT, Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Healthcare

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CMS Issues New Final Rule on Pricing Transparency

On November 15, CMS issued the Price Transparency Requirements for Hospitals to Make Standards Charges Public Final Rule (“Final Rule”), as directed by President Donald Trump’s Executive Order on Improving Price and Quality…more

Centers for Medicare & Medicaid Services (CMS), Executive Orders, Final Rules, Health Care Providers, Healthcare Reform

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Health Care “Prime” The Shaping of Health Care in America Through M+A and Innovation

This is a notable period for the modern health care industry in America. The health care ecosystem is evolving at an accelerating pace. How health care is owned, organized, delivered and paid for in the future will be different…more

Acquisitions, Analytics, Health Care Providers, Health Insurance, Healthcare Reform

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HHS’s Enforcement Discretion Notice May Signal More Potential Violations

The HHS Office for Civil Rights (“OCR”) issued a notice in the Federal Register regarding its Enforcement Discretion (84 Fed. Reg. 18151) on April 30, 2019. HHS announced that HHS will now apply a different cumulative annual…more

Civil Monetary Penalty, Data Breach, Electronic Medical Records, Enforcement Authority, Health Care Providers

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SCOTUS Declines to Review False Claims Act Cases on Falsity and Medical Judgment

On February 22, 2021, the United States Supreme Court declined to review two False Claims Act (FCA) cases, solidifying a split that pits the Eleventh Circuit against the Third and Ninth Circuits as to whether a disagreement over…more

Denial of Certiorari, False Claims Act (FCA), Health Care Providers, Healthcare Fraud, Liability

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Health Care M+A: The Emergence of “Supergroups” - Composed of Medical, Dental and Other Clinicians

Among the new models are “supergroups,” involving combinations of physicians, dentists, vision-care specialists or other individually licensed health care providers to participate in the current and future health care…more

Business Model, Business Ownership, Corporate Structures, Health Care Providers, Innovative Technology

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Texas Supreme Court Closes the Door to Transactional Fraud Claims Based on False Representations That Conflict With an Agreement’s Express Terms

A recent decision from the Texas Supreme Court has closed the door for good on certain fraud and fraudulent inducement claims based on false representations that are contradicted by the parties’ agreement. In Mercedes-Benz, LLC…more

Business Litigation, Car Dealerships, Contract Terms, Exclusive Dealing Agreements, Fraud

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Class Action Areas Drive EEOC’s Strategic Enforcement Plan for 2024 – 2028

Late last year, the EEOC quietly announced its most recent Strategic Enforcement Plan, covering 2024–2028. To no surprise, the EEOC has indicated that it will implement a concerted effort to focus its resources on employment…more

Employer Liability Issues, Equal Employment Opportunity Commission (EEOC), Hiring & Firing, Strategic Enforcement Plan, Wage and Hour

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New York Court Rejects Class and Collective Certification in Nationwide Sex-Bias Action

On November 30, 2018, the U.S. District Court for the Southern District of New York determined that a company’s decentralized pay and promotion structure made the matter unfit for class and collective certification under Title…more

Bias, Civil Rights Act, Class Action, Collective Actions, Commonality

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USPTO Issues Updated Guidance Focusing Examiners on Functional Language Used in Software Claims

The United States Patent Trademark Office (USPTO), issued updated examination guidance (Updated Guidance) for examining software claims defining an invention using functional language on January 7, 2019…more

Comment Period, Guidance Update, Intellectual Property Protection, Patent Applications, Patent Examinations

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DOJ Reaffirms Commitment to Prosecuting Individuals, Toughens Expectation for Corporate Response

The U.S. Department of Justice (DOJ) recently issued a memorandum ("The Yates memo") on September 9, 2015 by Deputy Attorney General Sally Yates, reaffirming the Government's commitment to prosecuting individuals. Say good-bye…more

Asset Seizure, Civil Forfeiture, Civil Monetary Penalty, Corporate Investigations, Criminal Prosecution

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Protecting Your Organization From Fraudulent Investments: Red Flags Of Fraud And Due Diligence

The Great Recession flushed out many Ponzi schemes and other fraudulent investment vehicles, bringing to light their prevalence and devastating effects. As the economy begins to rebound, new investment mechanisms and other…more

Corporate Counsel, Due Diligence, Fraud, White Collar Crimes

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Med-Staff Newsletter - January 2020 | VOL 4

With the New Year comes new medical staff leaders and a new set of growing pains. Contrary to what many of us believe, some simple steps can lessen the pain. …more

Anti-Competitive, Antitrust Violations, Breach of Contract, Covenant of Good Faith and Fair Dealing, Defamation

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24 Employment Law Updates for the New Year

Many state and local government employment laws go into effect on January 1, 2024.  Here is a non-exhaustive list of 24 employment law updates to ring in the New Year..…more

Employer Liability Issues, Hiring & Firing, Labor Reform, Labor Regulations, New Legislation

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Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

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Alleviate the Fear of a License Counterparty Filing for Bankruptcy

A legitimate fear among companies negotiating license agreements exists, and that is the fear of the license counterparty filing for bankruptcy. Given the business interruption that ultimately could occur as a result of a…more

Chapter 11, Commercial Bankruptcy, Contract Drafting, Contract Negotiations, Intellectual Property Protection

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Whitepaper On The Federal Reserve’s Main Street Business Lending Program As of April 3, 2020

On March 23, the Federal Reserve announced new measures it would be taking to support the credit markets and the broader economy in the face of the economic and credit disruption caused by the COVID-19 pandemic and related…more

CARES Act, Coronavirus/COVID-19, Federal Loans, Federal Reserve, Financial Stimulus

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Warning: Websites and Apps Must Comply with the ADA

Recently, the U.S. Ninth Circuit Court of Appeals ruled in Robles v. Domino’s Pizza that an employer’s websites and mobile applications, or “apps,” are subject to the strictures of the Americans with Disabilities Act, as amended…more

Americans with Disabilities Act (ADA), Class Action, Department of Justice (DOJ), Disability Discrimination, Dominos

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Cyber Security Insurance: Nine Questions to Ask to Determine Your Exposure

There is an increased interest in cyber security insurance for businesses amid frequent news of computer hacking, network intrusions, data theft, and high-profile ransomware attacks. Originally published in Houston Medical…more

Consumer Insurance Products, Cyber Attacks, Cyber Insurance, Cybersecurity, Data Breach

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Don't Get Your Feathers Ruffled: The Value of Exclusivity Provisions in Real Estate Agreements

Say you decide to open a chicken restaurant selling your secret family recipe chicken. You find the perfect location, sign the lease, move in, and open for business. Sales are brisk when a few weeks later you see a construction…more

Commercial Leases, Commercial Real Estate Market, Exclusivity Clauses, Landlords, Leases

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John McAfee Meet Agent Smith

 Agent Smith in the Matrix described humans as a “virus.  A disease, a cancer of this planet. You are a plague, and we are the cure.” While not alleging all human beings are a virus, the U.S. government views John McAfee, the…more

Anti-Fraud Provisions, Bitcoin, Celebrity Endorsements, Cryptocurrency, Digital Currency

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USPTO Patent Public Advisory Meeting - Highlights

The USPTO's PPAC Quarterly Meeting took place on May 3 at its headquarters in Alexandria, Virginia. Various topics affecting the USPTO, prosecution practice, and PTAB proceedings were discussed as an effort to open dialog…more

Innovation, Inter Partes Review (IPR) Proceeding, Oil States Energy Services v Greene's Energy Group, Patent Trial and Appeal Board, Patent-Eligible Subject Matter

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Georgia Senate Approves HB 987

On June 24, 2020, the Georgia Senate approved HB 987. The bill provides additional measures of protection for residents of assisted living facilities and personal care homes. The bill had previously passed the Georgia House, and…more

Assisted Living Facilities (ALFs), Health Care Providers, Healthcare Facilities, Legislative Agendas, Pending Legislation

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OSHA Ups the Ante: Changes to Your Injury Reporting Obligations in 2015

The Occupational Safety and Hazard Administration ("OSHA") is the federal agency within the Department of Labor that is tasked with reducing workplace hazards and implementing worker health and safety protections. To that end,…more

Department of Labor (DOL), Employer Mandates, OSHA, Recordkeeping Requirements, Reporting Requirements

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

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Fantasy Sports Sites Win Challenge to Publicity Rights in Indiana

Recently, the Seventh Circuit affirmed that fantasy sports operators, such as FanDuel and Draft Kings, do not violate a student athlete’s right of publicity under Indiana law by using their name, image and likeness without their…more

DraftKings, FanDuel, Fantasy Sports, Gambling, Name and Likeness

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Lender's Edge Newsletter: December 2016

Enforcement of a Commercial Loan After the Property Securing the Loan is Sold or Transferred - Enforcement of due-on-sale clauses started growing in popularity in the 1970s as a result of instability in the economy and rising…more

Banking Sector, Borrowers, Chapter 11, Commercial Bankruptcy, Commercial Loans

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Polsinelli Represents Lender in Originating Sharia'h Compliant Financing of Commercial Real Estate Secured by Assisted Living Facilities

As commercial real estate investment has increasingly become global in nature, banks and other lenders are likely to see Sharia’h compliant financing opportunities in markets across the United States…more

Assisted Living Facilities (ALFs), Financial Institutions, Financial Services Industry, Financing, Foreign Investment

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California Court of Appeal Approves Variable Hourly-Based Compensation Plan

In recent years, California courts have complicated the lives of employers that utilize commission and piece rate compensation systems (i.e., “activity-based compensation”). …more

Appeals, Compensation & Benefits, Employer Liability Issues, Employment Litigation, Labor Law Violations

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Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

See all updates »

Think Outside the Box: District Court Reminds Employers to Carefully Review EEOC Charges

Recently, the U.S. District Court for the Southern District of Alabama issued a decision reminding employers to take care when reviewing and responding to charges of discrimination…more

Administrative Remedies, Disability Discrimination, Employer Liability Issues, Employment Litigation, Equal Employment Opportunity Commission (EEOC)

See all updates »

Design Patent vs. Trade Dress: Strategic Considerations for Protecting Product Designs

Product designs often serve as the cornerstone of a brand’s identity, evoking instant recognition and loyalty among consumers. From the iconic silhouette of Coca-Cola’s glass bottle to the distinctive shape of Gibson guitars,…more

Acquired Distinctiveness, Consumer Product Companies, Corporate Branding, Design Patent, Intellectual Property Protection

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Brexit and Its Effect on European Union Trademarks

As you may be aware, the transition period for Brexit and the withdrawal of the United Kingdom from the European Union likely ends on December 31, 2020. The completion of the withdrawal initiated February 1, 2020, will have an…more

Domain Names, EU, European Union Trade Mark (EUTM), Intellectual Property Protection, Trademark Registration

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New Federal Rule of Criminal Procedure 16.1 Aims to Assist Practitioners in Disclosure and Discovery of Electronically Stored Information in Complex Cases

On December 1, 2019, Federal Rule of Criminal Procedure 16.1 (Rule 16.1 or the “Rule”) went into effect. With a focus on defense counsel’s ability to adequately prepare for trial, the Rule functions as a response to concerns…more

Client Services, Data Management, Defense Strategies, Disclosure Requirements, Discovery

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Reopening Hospital Service Lines: A Playbook for Moving Forward

The COVID-19 pandemic has created severe financial and operational difficulties for hospitals. Rapidly responding to a novel pathogen within a declared Public Health Emergency (PHE), while experiencing decreased revenues as a…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Responsibilities, Re-Opening Guidelines, Return-to-Work Agreements

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Infringement Liability for US Products Sold Abroad: Could Supreme Court Reverse CAFC?

A case currently pending petition to the United States Supreme Court could further define the scope of potential patent infringement liability for U.S. based companies that sell products intended to be used abroad. If the…more

Amicus Briefs, CAFC, Foreign Sales, Intellectual Property Protection, Lost Profits

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USPTO Seeks to Change BRI Patent Claim Construction Standard

The United States Patent Trademark Office announced on May 8 that it proposes to replace the broadest reasonable interpretation (“BRI”) standard for construing unexpired patents with the same standard used in Federal district…more

Broadest Reasonable Interpretation Standard, Claim Construction, Comment Period, Inter Partes Review (IPR) Proceeding, Patent Trial and Appeal Board

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Colorado Supreme Court to Rule on Yet Another Key Construction Defects Issue

On July 5, 2016, the Colorado Supreme Court announced it will consider the construction defects case of Forest City Stapleton, Inc., et al. v. Rogers. In this case the Colorado Court of Appeals, for the first time, imposed an…more

CO Supreme Court, Construction Defects, Construction Industry, Construction Litigation, Construction Project

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Polsinelli Represents Water Authority in Bond Refunding of San Diego County Water Authority Desalination Project Pipeline

Polsinelli attorneys recently represented the San Diego County Water Authority in the sale of $183,155,000 in refunding bonds for the Claude “Bud” Lewis Carlsbad Desalination Project Pipeline…more

Bonds, Desalination, Infrastructure, Investment Opportunities, Public Private Partnerships (P3s)

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What's More Appealing Than Property Taxes? Recent Kansas Legislative Changes Make This Year An Opportune Time to Appeal Yours

Do you or your company own real property in Kansas? If so, then challenging your property's tax valuation is more appealing than ever, thanks to the 2014 Kansas Legislature…more

Legislative Agendas, Property Tax, Property Valuation, State Taxes

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The Restasis Patents and Tribal Sovereign Immunity: New Developments

The battle between Mylan and Allergan over the six Orange Book patents covering Restasis has taken a next formal step. On Sept. 22, the new patent-owner, the Saint Regis Mohawk Tribe, moved to dismiss Mylan’s requests for inter…more

Allergan Inc, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Mylan Pharmaceuticals, Native American Issues

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John McAfee Meet Agent Smith

 Agent Smith in the Matrix described humans as a “virus.  A disease, a cancer of this planet. You are a plague, and we are the cure.” While not alleging all human beings are a virus, the U.S. government views John McAfee, the…more

Anti-Fraud Provisions, Bitcoin, Celebrity Endorsements, Cryptocurrency, Digital Currency

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New Guidance on Mandatory Notice in the Biosimilar ‘Patent Dance’

The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing. The ruling weighed in on a key…more

Amgen, Apotex, Biosimilars, BPCIA, Generic Drugs

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H&M Fined 37.8 Million Dollars for Alleged GDPR Violations

What Happened? On October 1, 2020, the Hamburg Data Protection Commissioner (“Hamburg DPA”) fined clothing retailer H&M 37.8 million dollars (EURO 35.2 million) for several violations of the GDPR…more

Data Breach, Data Collection, Data Management, Data Protection, Data Retention

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Breaking News: SCOTUS Rules Today CERCLA Does Not Preempt State Statutes of Repose

The United States Supreme Court today ruled that the Comprehensive Environmental Response, Compensation, and Liability Act ("CERCLA"), enacted in 1980 to "promote the timely cleanup of hazardous waste sites," does not pre-empt a…more

CERCLA, Contaminated Properties, CTS Corp v Waldburger, Environmental Liability, Environmental Policies

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Third Circuit Approves a Structured Dismissal that Allows Debtor to Skip Payments to Certain Creditors

The Third Circuit recently affirmed a bankruptcy court's approval of a joint settlement and structured dismissal of a chapter 11 case that did not comply with the priority scheme under the Bankruptcy Code by providing payment to…more

Appeals, Bankruptcy Code, Chapter 11, Commercial Bankruptcy, Creditors

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Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute of…more

Bayh-Dole Act, Draft Guidance, Drug Pricing, Federal Trade Commission (FTC), Healthcare

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Supreme Court Rules Retaliatory Intent Not Required Under SOX

In a groundbreaking decision, the U.S. Supreme Court unanimously ruled today in favor of whistleblower Trevor Murray, dispelling the notion that whistleblowers must prove retaliatory intent to be protected under federal law…more

Adverse Employment Action, Corporate Finance, Hiring & Firing, Murray v UBS Securities LLC, Retaliation

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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Walkout Wednesday—What Rights Do Employers Have?

Walkouts by non-union employees have increased sharply over the past couple of years. “Walkout Wednesdays” have become a favorite organizing strategy for labor unions. Unions, like SEIU, make a significant investment of their…more

Collective Bargaining Agreements (CBA), Employee Rights, Labor Disputes, NLRA, NLRB

See all updates »

Impending Deadline: CMS Issues Proposed Rule Reform for Long Term Care Facilities – Part 4 of 4

On July 16, 2015, the Federal Register published Centers for Medicare and Medicaid Services' (CMS) proposed rule to reform the requirements for Long Term Care Facilities participating in Medicare and Medicaid. CMS will be…more

Centers for Medicare & Medicaid Services (CMS), Federal Register, Health Care Providers, Healthcare, Hospitals

See all updates »

New Discovery Order Requiring Greater Transparency Regarding Bankruptcy Trust Claims in Southern California Asbestos Litigation

On May 27, 2015, the Honorable Emilie H. Elias, the coordination judge who presides over all asbestos litigation in the counties of Los Angeles, Orange, and San Diego (LAOSD), issued a discovery order entitled “Case Management…more

Asbestos, Asbestos Litigation, Commercial Bankruptcy, Discovery, Interrogatories

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New Discovery Order Requiring Greater Transparency Regarding Bankruptcy Trust Claims in Southern California Asbestos Litigation

On May 27, 2015, the Honorable Emilie H. Elias, the coordination judge who presides over all asbestos litigation in the counties of Los Angeles, Orange, and San Diego (LAOSD), issued a discovery order entitled “Case Management…more

Asbestos, Asbestos Litigation, Commercial Bankruptcy, Discovery, Interrogatories

See all updates »

Remote Patient Monitoring Opportunities and Risks for Technology Vendors and Providers

In recent years, the Centers for Medicare and Medicaid Services (CMS) has expanded coverage for remote patient monitoring (RPM) services under Medicare. RPM services include establishing, implementing, revising, and monitoring a…more

Billing, Centers for Medicare & Medicaid Services (CMS), Data Management, Data Privacy, Digital Health

See all updates »

Looking Around the Corner: Colorado’s Public Option Waits in the Wings

As recently as March, 2020, before the coronavirus pandemic upended public life, the Colorado legislature was poised to enact significant new health care reforms…more

Affordable Care Act, Coronavirus/COVID-19, Health Insurance, Healthcare Reform, State and Local Government

See all updates »

"Please Pay No Attention to the Microphone:” DOJ Announces New Program Offering Protections to Criminal Whistleblowers

On April 15, 2024, the Criminal Division of the U.S. Department of Justice (“DOJ”) released new guidance relating to a Pilot Program on Voluntary Self-Disclosures for Individuals, promising to offer protection from criminal…more

Cooperative Compliance Regime, Corporate Governance, Corporate Misconduct, Criminal Prosecution, Department of Justice (DOJ)

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ERISA Fiduciary Rules: Court Challenges and Considerations for Employers

Employers and their financial advisors should consider enacting a multi-step plan amid anticipation that the proposed ERISA Fiduciary Rules turn effective. Last month, several business groups filed a complaint in the…more

Best Interest Contract Exemptions, Best Interest Standard, Brokers, Department of Labor (DOL), Employee Retirement Income Security Act (ERISA)

See all updates »

Corporate Governance Emerging Best Practices Series: Gender-Diverse Boards

Washington State is the latest state to respond to studies showing a gap between the percentage of women in the workforce and the percentage of women serving on corporate boards. Referencing a 2018 report from Deloitte and the…more

Best Practices, Board of Directors, Corporate Governance, Diversity, Gender Equity

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“Vague” Insurance Policy Requires Insurer to Defend Lawyer in Criminal Case, New York Judge Rules

After a recent ruling by Eastern District of New York Judge Joan Azrack, Fireman’s Fund Insurance Co. will have to provide defense for Jason Kurland, also known as the “Lottery Lawyer,” in the criminal action against him…more

Criminal Prosecution, Denial of Insurance Coverage, Duty to Defend, Extortion, Financial Fraud

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Senate Bill 1152: California’s Hospital Discharge Policy for Homeless Patients and How It May Affect Substance Use Disorder Treatment Providers

Governor Jerry Brown signed Senate Bill (SB) 1152 into law on September 30, 2018. SB 1152 modifies Section 1262.5 of the Health & Safety Code which currently requires hospitals to have a written discharge planning policy and…more

Health & Safety Standard, Health Care Providers, Healthcare Facilities, Homeless Issues, Hospitals

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DOJ Remains “Laser-Focused” on Criminal Telemedicine Enforcement

In a one-two punch during the first half of September 2019, the Department of Justice confirmed that its focus on prosecuting telemedicine companies and physicians engaged in health care fraud shows no sign of slowing down. …more

Criminal Conspiracy, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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FDA's 'Conversation Starter' Paper Suggests Altered Approach for Laboratories

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating…more

CLIA, Clinical Laboratories, Food and Drug Administration (FDA), Healthcare, Innovation

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The Proposed Build Back Better Act Moves Forward After the House Passes a Revised Version of the Bill

Overview - Over the past year, several tax law changes have been proposed by the Biden administration and, in September 2021, draft legislative language was circulated, which set forth proposed changes to the Internal…more

Biden Administration, Capital Gains Tax, Corporate Taxes, Foreign Derived Intangible Income (FDII), Foreign Tax Credits

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Under The New HIPAA Regime, A Lost Laptop Costs $1.5 Million But A Leased Photocopier Costs Almost As Much

Nearly one year after a Massachusetts provider paid $1.5 million to settle potential HIPAA violations for the theft of an unencrypted laptop containing protected health information (PHI), providers are reminded once again of how…more

Breach Notification Rule, Data Breach, Federal Trade Commission (FTC), Health Insurance Portability and Accountability Act (HIPAA), HIPAA Omnibus Rule

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U.S. State Privacy Law Update

In 2023, new comprehensive data privacy laws come into effect in five states — California, Colorado, Connecticut, Utah, and Virginia. The California Privacy Rights Act of 2020 (CPRA) and the Virginia Consumer Data Protection Act…more

Consumer Privacy Rights, Cybersecurity, Data Collection, Data Management, Data Privacy

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Med-Staff Newsletter - February 2023 | VOL 11

Structure of AMCs - While every AMC is unique, there are some common characteristics that many share: (1) the hospital and school are often tethered together from an organizational, governance and/or legal perspective; (2)…more

Accreditation, Coronavirus/COVID-19, Credentialing, Health Care Providers, Healthcare

See all updates »

Challenge to Corporate Transparency Act Prevails – For Now

On March 1, 2024, a U.S. District Judge in Alabama issued a judgment holding that the Corporate Transparency Act (CTA) is unconstitutional because it exceeds the Constitution’s limits on Congress’ power. Further, FinCEN is…more

Anti-Corruption, Anti-Money Laundering, Beneficial Owner, Congressional Authority, Constitutional Challenges

See all updates »

The Time is Now for Employers to Prepare for Illinois’ Paid Leave for All Workers Act

On January 1, 2024, Illinois will join Maine and Nevada as the only U.S. states to mandate that covered employers provide their employees with earned paid leave that can be used for any reason. Generally, the Paid Leave for All…more

Earned Sick Time, Employee Benefits, Employees, Employer Liability Issues, Illinois

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California’s AB 3129 Continues National Trend of Scrutinizing Private Equity Investments in the Health Care Industry

The California legislature is considering a bill that could severely impact the ability for private equity companies and hedge funds to operate in the California health care industry. AB 3129, introduced by Assembly Member Jim…more

Acquisition Agreements, California, Healthcare, Hedge Funds, Investment

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Recent Regulatory Action Against an Unlicensed Insurance Administrator in Florida

The Florida Office of Insurance Regulation (“Florida OIR”) recently took regulatory action against a New York-based company (“Company”) regarding its alleged unlicensed activities in Florida. According to the Florida OIR, the…more

Certificate of Authority, Enforcement Actions, Florida, Insurance Regulations, Licensing Rules

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Finding the Time: SEC Announces Deadline Extension for MCDC Initiative

Since 1995, the SEC’s Rule 15c-12 has, subject to a few exceptions, required the “post issuance” delivery of certain annual financial and operating information from parties that are obligated to provide for the repayment of…more

Deadlines, Disclosure Requirements, MCDC, Municipal Bonds, Securities and Exchange Commission (SEC)

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USPTO Issues Updated Guidance Focusing Examiners on Functional Language Used in Software Claims

The United States Patent Trademark Office (USPTO), issued updated examination guidance (Updated Guidance) for examining software claims defining an invention using functional language on January 7, 2019…more

Comment Period, Guidance Update, Intellectual Property Protection, Patent Applications, Patent Examinations

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Fireworks Are Coming Before Independence Day

Mark your calendars for July 3—the date we will likely learn whether a Texas Court will enjoin the FTC Rule banning non-competes from taking effect on September 4. This week, Judge Ada Brown, the presiding judge in Ryan, LLC v…more

Competition, Confidential Information, Employer Liability Issues, Employment Contract, Federal Labor Laws

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Unanimous Supreme Court Yesterday in Mortgage Bankers: Notice-and-Comment Not Required for Interpretive Rulemaking

On March 9th, 2015 the U.S. Supreme Court unanimously reversed the D.C. Circuit's opinion on federal agency rulemaking in Perez, Secretary of Labor v. Mortgage Bankers Association, holding that federal agencies need not issue…more

Administrative Procedure Act, Department of Labor (DOL), Fair Labor Standards Act (FLSA), Mortgage Loan Originators, Notice and Comment

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2016 Antitrust Case Law And FTC Action Highlights FTC Agency’s Approach To Hospital Mergers

In 2016, the Federal Trade Commission prevailed in litigation before the Third and Seventh Circuit Courts of Appeal related to two high-profile hospital mergers. In both cases, the courts of appeal overturned the federal…more

Anticompetitive Behavior, Antitrust Litigation, Antitrust Provisions, Federal Trade Commission (FTC), Geographic Markets

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SCOTUS to Determine Key Aspects of Government Dismissal Authority in FCA Cases

The United States Supreme Court recently agreed to hear a case interpreting the False Claims Act (“FCA”) that may affect the government’s involvement in pending and future matters. To resolve a circuit split, the Court will…more

Burden-Shifting, Certiorari, Department of Justice (DOJ), False Claims Act (FCA), Federal Health Care Programs (FHCP)

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FDA 2023-24: A Look Back & A Peek Forward

Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased…more

Artificial Intelligence, Baby Products, FDA Approval, Food and Drug Administration (FDA), Healthcare

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CIT Upholds List 3 and 4 Section 301 Tariffs

On Friday, March 17, the United States Court of International Trade (“CIT”) upheld the List 3 and List 4 tariffs imposed on Chinese imports in litigation brought by more than 3600 importers challenging the United States Trade…more

Administrative Procedure Act, China, Court of International Trade, Imports, Section 301

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California Bill SB 642 Will Not Move Forward This Year

On May 20, 2021, the California Senate Appropriations Committee placed Senate Bill 642 (“SB 642”) on the “2-year” bill list, meaning that the proposed legislation will not move forward in the current legislative session…more

Health Care Providers, Hospitals, Private Equity Firms, State and Local Government

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Health Reform + Related Health Policy News - July 2013

In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare…more

Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), Competitive Bidding, Contraceptive Coverage Mandate, Contraceptives

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Upcoming Deadline to Notify California Employees Subject to Non-Competes

As we reported last month, effective January 1, 2024, non-compete agreements in California are unenforceable regardless of where the contract is signed. This means employees who sign non-competes outside California, then move to…more

Employer Liability Issues, Employment Contract, Hiring & Firing, Intellectual Property Protection, Labor Reform

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Biden’s October 30, 2023, Executive Order on AI: Key Takeaways for Health Care Stakeholders

The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI has…more

Artificial Intelligence, Health Information Technologies, Health Insurance Portability and Accountability Act (HIPAA), Healthcare, HITECH Act

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Must Employers Translate Workplace Documents into Other Languages? Should They?

Around the world and across the United States, we see so many languages spoken. People around the world communicate in thousands of different languages. Given the wide origins of workers and companies with international…more

Document Management, Employee Handbooks, Employees, Employer Liability Issues, Employment Policies

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Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

See all updates »

Relax Jack...It’s Only a Joke!

Jack Daniel’s Properties, Inc. v. VIP Products LLC. (Docket 22-148) On March 22, 2023, VIP Products LLC told the Supreme Court that its parody Bad Spaniels whiskey-bottle-shaped dog toys do not violate the Lanham Act…more

First Amendment, Free Speech, Intellectual Property Protection, Jack Daniels Properties Inc v VIP Products LLC, Lanham Act

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Delaware Court of Chancery Establishes Duty of Oversight Extends to Officers

In a significant and far-reaching development in Delaware corporate law, the Delaware Court of Chancery recently held in In re McDonald’s Corporation Stockholder Derivative Litigation, C.A. No. 2021-0324-JTL (Del. Ch. Jan. 25,…more

Board of Directors, Breach of Duty, Caremark claim, Corporate Culture, Corporate Officers

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Fall Congressional Forecast: Eye on Federal Funding and Health Care

Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the…more

Abortion, Biden Administration, Continuing Resolution, Federal Funding, Food and Drug Administration (FDA)

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Proposed And Final Rules Released Regarding The ACA's Individual Mandate

In This Issue: - Minimum Essential Coverage ..HHS Proposed Rule - Shared Responsibility Payments and Exemptions ..HHS Proposed Rule ..IRS Proposed Rule ..IRS Final Rule - Essential Health Benefits …more

Affordable Care Act, Congressional Budget Office, Department of Health and Human Services (HHS), Essential Health Benefits, Health Insurance Exchanges

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DOJ Continues to Target Lab Sales Arrangements and Ordering Practices

Signaling its continued scrutiny of the laboratory industry, the Department of Justice (DOJ) entered into a settlement agreement with Texas lab Genotox Laboratories Ltd. last month related to compensation Genotox paid to sales…more

Anti-Kickback Statute, Compensation, Department of Justice (DOJ), Eliminating Kickbacks in Recovery Act of 2018 (EKRA), Enforcement Actions

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HHS Finalized Part 2 Revisions: What Has Changed?

On February 8, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), released final rule (Final Rule)…more

CARES Act, Department of Health and Human Services (HHS), Final Rules, Health Care Providers, Health Insurance Portability and Accountability Act (HIPAA)

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Reminder: Upcoming Filing Deadlines for Fund Managers

With the new year comes a number of annual compliance obligations for evaluation by investment fund managers. In addition to the obligation for registered investment advisers to conduct an annual review of their compliance…more

Beneficial Owner, Filing Deadlines, Fund Managers, Hedge Funds, Investment Funds

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The FAR Council’s Implementation of the “No TikTok on Government Devices Act” - Applicability, Limited Exceptions and the FAR Council’s Expectation of Impact of the Rule

Background - In December of 2022, Congress passed the “No TikTok on Government Devices Act” as part of the Consolidated Appropriations Act, 2023 to address the risks presented by the app to sensitive government data. This law…more

China, Consolidated Appropriations Act (CAA), Data Collection, Federal Acquisition Regulations (FAR), Federal Bans

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First NYDFS Cybersecurity Enforcement Action Arising From a Standard Examination Results in $1.5 Million Penalty

On March 1, 2017, the New York State Department of Financial Services (“NYDFS”) Cybersecurity Requirements for Financial Services Companies (the “Cybersecurity Regulation”) became effective. Fast forward four years, where NYDFS…more

Covered Entities, Cybersecurity, Cybersecurity Framework, Data Protection, Financial Institutions

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Blockchain Technology: High-Profile Use Cases in the News and Other Alternative Use Cases

Cryptocurrencies and non-fungible token (NFT) news headlines currently focus on the market crash (sometimes framed as a crypto-winter or cryptoextinction), fraud and the collapse of various crypto exchange platforms — or the…more

Blockchain, Contract Terms, Cryptocurrency, Non-Fungible Tokens (NFTs), Popular

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Chirp, Buzz, Blink: How the Eleventh Circuit Brought New Life to Challenging Injury Claims in TCPA Class Actions

The Eleventh Circuit’s recent decision in Salcedo v. Hanna, brings good news to the Telephone Consumer Protection Act (“TCPA”) defense bar by breathing new life into challenges objecting to statutory injury in TCPA class action…more

Article III, Class Action, Injury-in-Fact, Interlocutory Appeals, Invasion of Privacy

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Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

See all updates »

How FinTech Could Reboot LIBOR

Part One of this two part E-alert looked at the challenges facing London Inter-Bank Offered Rate (LIBOR) LIBOR and how the syndicated loan market is dealing with the potential non-availability of these rates. Part two considers…more

Benchmarks, Blockchain, Distributed Ledger Technology (DLT), Financial Transactions, FinTech

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Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

See all updates »

Federal District Court Rejects Hospital Employees’ Attempt to Stop Vaccination Mandate During Legal Battle

In September, 40 current and former employees of St. Elizabeth Medical Center in Kentucky sued the privately-owned hospital over its mandatory COVID-19 vaccination policy, alleging violations of their constitutional rights, the…more

Coronavirus/COVID-19, Critical Infrastructure Sectors, Emergency Management Plans, Employer Liability Issues, Employer Mandates

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Finally Final — The DOL Issues Its Long-Expected Final Rule Raising the FLSA Overtime Exemption Salary Thresholds

As has been expected, and as we addressed at the end of 2023 in our previous blog post, on April 23, the U.S. Department of Labor (“DOL”) at long last issued its final rule raising the salary thresholds for overtime exemptions…more

Department of Labor (DOL), Employer Liability Issues, Exempt-Employees, Fair Labor Standards Act (FLSA), Federal Labor Laws

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Wait a New York Minute – Is California’s Prop 65 Chemical Warning Statute Making its Way out East?

Earlier this year, New York Governor Andrew Cuomo announced a proposal to add stringent labeling requirements for certain products sold in New York through the “Consumer Right to Know Act” (the “Proposed Act”)…more

Environmental Policies, Manufacturer Liability, Mass Tort Litigation, Product Labels, Proposition 65

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California Brings Back Paid Covid-19 Sick Leave

On January 25, 2022, California Governor Gavin Newsom, Senate President pro Tempore Toni G. Atkins, and Assembly Speaker Anthony Rendon announced a framework for an agreement to reactivate California’s COVID-19 paid supplemental…more

Coronavirus/COVID-19, Employee Rights, Infectious Diseases, Paid Sick Leave, Sick Leave

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California Hospitals Cannot Use an Exclusive Contract to do an End-Run around a Medical Staff Member’s Right to Notice and a Fair Hearing

Economy v. Sutter East Bay Hospitals (Feb. 4, 2019, A150211, A150738, A150962) __ Cal.App.5th __ [2019 WL 422346] - The California First District Court of Appeal has addressed an issue often dealt with by hospitals with…more

Contract Terms, Due Process, Employee Rights, Employer Liability Issues, Employment Litigation

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Medicare Continues its Updates to Provider Enrollment Policies as Part of Efforts to Enhance Program Integrity and Transparency

The Centers for Medicare & Medicaid Services (“CMS”) continued its efforts to increase oversight of the Medicare program by updating Medicare provider enrollment regulations and policies through recent regulatory and…more

Centers for Medicare & Medicaid Services (CMS), Enrollment, Health Care Providers, Health Insurance, Healthcare

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Med-Staff Newsletter - February 2023 | VOL 11

Structure of AMCs - While every AMC is unique, there are some common characteristics that many share: (1) the hospital and school are often tethered together from an organizational, governance and/or legal perspective; (2)…more

Accreditation, Coronavirus/COVID-19, Credentialing, Health Care Providers, Healthcare

See all updates »

During a Global Health Crisis, IP Rights Are Getting a Bad Rap

Four months ago, the U.S. became one of 100 countries supporting the proposal presented a year ago to the World Trade Organization (WTO) by India and South Africa that intellectual property protection for COVID-19 vaccines be…more

Coronavirus/COVID-19, Infectious Diseases, Intellectual Property Protection, Manufacturers, Patent Ownership

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Illinois Court Strikes Down ESOP’s Arbitration Provision

Over the past few years, qualified retirement plans, including employee stock ownership plans (ESOPs) have been adding provisions requiring participant breach of fiduciary duty claims to be resolved through mandatory arbitration…more

Arbitration, Breach of Duty, Employee Benefits, Employee Retirement Income Security Act (ERISA), ESOP

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Health Care Fraud and Abuse 2023 Year in Review

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement…more

Anti-Kickback Statute, Department of Justice (DOJ), Enforcement Actions, False Claims Act (FCA), Fraud and Abuse

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Laws and Regulations Affecting Government Contractors

Government contractors wondering whether and when they can protest military and civilian task and delivery orders should be aware of recent changes in the law affecting a party’s right to protest before the General Accounting…more

Attorney's Fees, Bid Protests, Civilian Agency Task Orders, Corrective Actions, Federal Contractors

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Catching Up With the Times: CMS Reforms Long-Term Care Facility Requirements - Part II

Following CMS publishing the biggest overhaul to federal long-term care regulations in 25 years, affected facilities must take steps to ensure they are prepared for the pending changes. On Oct. 4, CMS published the lengthy…more

Arbitration, Arbitration Agreements, Binding Arbitration, Centers for Medicare & Medicaid Services (CMS), Contract Terms

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New York Targets Real Estate Owners in New LLC Transparency Law

Riding a wave of ownership disclosure laws began with the passage of the federal Corporate Transparency Act (CTA), on December 22, 2023, Governor Hochul signed New York’s own “LLC Transparency Act” (the NY-LLCTA), passed by the…more

Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes, FinCEN

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SEC Adopts Cybersecurity Incident and Risk Management Disclosure Rules

On July 26, 2023, the Securities and Exchange Commission (the “SEC”) adopted new rules requiring public companies to disclose within four business days material cybersecurity incidents they experience and to disclose annually…more

Cyber Attacks, Cybersecurity, Data Breach, Data Protection, Data Security

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Two Week Old DOJ COVID-19 Fraud Task Force Announces First Wave of Prosecutions—Many More Are Likely On The Horizon

Last week, in light of the Department of Justice’s newly-formed COVID-19 Fraud Enforcement Task Force, we cautioned that COVID-related prosecutions were likely imminent. And on the heels of this DOJ task force, we are already…more

Anti-Corruption, Coronavirus/COVID-19, Corruption, Department of Justice (DOJ), Enforcement Actions

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Part-time Employee Rights under the SECURE Act

On December 12, 2019, Congress passed the “Setting Every Setting Every Community Up for Retirement Enhancement Act of 2019” (the “SECURE Act”). The SECURE Act included provisions regarding part-time employees that may require…more

401k, Employee Benefits, Part-Time Employees, Retirement Plan, SECURE Act

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Estate Planning During Periods of Inflation and Market Volatility

Earlier this year the stock market entered bear market territory.  This happens when the market declines more than 20% or more from its most recent high.  The market decline has been attributed to several factors including…more

Charitable Remainder Trust, Estate Planning, Estate Tax, Estate-Tax Exemption, Gift Tax

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Data Scraping Update: ‘LinkedIn v. hiQ’ Answers Some Questions but Leaves Many More Open

2022 provided companies with further clarity and insight regarding legal claims that might be viable to stop data (or web) scraping and those that likely won’t work. Data scraping continues to become an increasingly popular…more

Breach of Contract, Computer Fraud and Abuse Act (CFAA), LinkedIn, Personally Identifiable Information, Popular

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FTC and DOJ Signal Greatly Increased Scrutiny of Private Equity Firms’ Acquisitions in Health Care

The top enforcers at the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) are sending strong signals that private equity (PE) firms are likely to be the next target in the Biden…more

Acquisitions, Antitrust Provisions, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Department of Justice (DOJ)

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Illinois Law Places New Limits Restrictive Covenants

On January 1, 2022, Public Act 102-0358, an amendment to the Illinois Freedom to Work Act will take effect and impact all non-compete agreements entered into prospectively. The law will ban employers from using non-compete…more

Confidential Information, Contract Terms, Employer Liability Issues, Employment Contract, Hiring & Firing

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U.S. Supreme Court Holds That The Federal Arbitration Act Preempts California’s Rule Prohibiting Contractual Arbitration of Individual PAGA Claims

On June 15, 2022, the U.S. Supreme Court issued its highly anticipated opinion in Viking River Cruises, Inc. v. Moriana, which considered whether or not claims brought under the California Private Attorneys General Act (“PAGA”)…more

Arbitration, Arbitration Agreements, California, Class Action, Class Action Arbitration Waivers

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FDA 2023-24: A Look Back & A Peek Forward

Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased…more

Artificial Intelligence, Baby Products, FDA Approval, Food and Drug Administration (FDA), Healthcare

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Blockchain Technology: High-Profile Use Cases in the News and Other Alternative Use Cases

Cryptocurrencies and non-fungible token (NFT) news headlines currently focus on the market crash (sometimes framed as a crypto-winter or cryptoextinction), fraud and the collapse of various crypto exchange platforms — or the…more

Blockchain, Contract Terms, Cryptocurrency, Non-Fungible Tokens (NFTs), Popular

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Clarification of OSHA Rule Regarding Drug Testing and Safety Incentive Programs

In 2016, the Occupational Safety and Health Administration (“OSHA”) published a rule (the “2016 Rule”) – found in 29 C.F.R. § 1904.35(b)(1)(iv) – related to post-incident drug testing and workplace safety incentive programs…more

Anti-Retaliation Provisions, Drug Testing, Employee Incentive Plans, Employer Liability Issues, OSHA

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SEC Significantly Modifies Disclosure Rules for Mining Companies

On October 31, 2018, the United States Securities and Exchange Commission (SEC) amended its rules to revise and modernize disclosure requirements applicable to companies with mining properties or operations…more

Disclosure Requirements, Energy Sector, Gas Royalties, Mineral Exploration, Mining

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Med-Staff Newsletter - February 2023 | VOL 11

Structure of AMCs - While every AMC is unique, there are some common characteristics that many share: (1) the hospital and school are often tethered together from an organizational, governance and/or legal perspective; (2)…more

Accreditation, Coronavirus/COVID-19, Credentialing, Health Care Providers, Healthcare

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Proposed Colorado Rule Clarifies that Paid Time Off Is Included within State’s Existing Prohibition of Use-It-Or-Lose-It Vacation Policies

The Colorado Department of Labor and Employment (“CDLE”) recently issued several proposed rules, including new language defining “vacation pay” for purposes of Colorado’s wage laws. Colorado law has long defined “wages” and…more

CO Supreme Court, Employee Benefits, Employer Liability Issues, Employment Litigation, Employment Policies

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Polsinelli Podcast - Selling Your Business

When planning for the sale of a business, business owners may not recognize the value of a business’ intangible assets. Or, they may not be familiar with the process of transferring or selling those assets. For certain types of…more

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Prop 15 is Ready to Rock Commercial Properties with the Split-Roll

On November 3, 2020, California voters will decide on Proposition 15, the citizen-initiated proposition that seeks to create a split-roll tax system in California. Also known as “The California Schools and Local Communities…more

Ballot Measures, Property Owners, Property Tax, Property Valuation, Real Estate Market

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Fourteen Years Later: New OIG Guidance On Excluded Providers

In This Issue: - Exclusion from Federal Health Care Programs - The New Advisory Bulletin - What Providers Should Know - For More Information - Excerpt from Exclusion from Federal Health Care…more

Civil Monetary Penalty, Disclosure Requirements, Excluded Providers, False Claims Act (FCA), Healthcare

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Using Endowed Funds in a Crisis: Key Considerations

It goes without saying that we are living in uncertain times and are experiencing events that are reshaping our lives in ways that many of us believed only to exist in science fiction books and movies. Nevertheless, while we all…more

Charitable Organizations, Coronavirus/COVID-19, Endowment Funds

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Virginia General Assembly Reverses Virginia Supreme Court on Requirement that Leases of more than Five Years be in the form of a Deed

In legislative action that will be welcomed by Virginia landlords and their mortgage lenders, the Virginia General Assembly, in its most recent session, amended the Virginia Statute of Conveyances (Va. Code Ann. § 55-2) to…more

Deeds, General Assembly, Landlords, Leases, Reversal

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California Bill SB 642 Will Not Move Forward This Year

On May 20, 2021, the California Senate Appropriations Committee placed Senate Bill 642 (“SB 642”) on the “2-year” bill list, meaning that the proposed legislation will not move forward in the current legislative session…more

Health Care Providers, Hospitals, Private Equity Firms, State and Local Government

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The Future Of Patentable DNA: A Myriad Of Possibilities

In This Issue: - Summary - Case Analysis - Implications ..Prokaryotic Nucleic Acid Sequences ..Short Segments of Eukaryotic DNA ..Promoters/Regulatory regions ..Isolated Proteins …more

AMP v Myriad, DNA, Genetic Materials, Myriad, Patent-Eligible Subject Matter

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Patient-Centered Sustainable Health Care

I. INTRODUCTION - Over the past two years, global events reshaped the health care industry by shifting the priorities of the industry’s key stakeholders. In the post-Covid-19 economy, quick responses to short-term problems…more

Healthcare, Healthcare Reform, Hospital Mergers, Patient-Specific, Patients

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OSHA Related Changes in 2019: The New Year Giveth, and the New Year Taketh Away

While the increased civil monetary penalties may impact an employer’s bottom line, OSHA did provide welcome relief to employers just two days later. …more

Electronic Filing, Employer Liability Issues, Final Rules, OSHA, Regulatory Reform

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Health Care Reimbursement and Payor Dispute Update - September 2022

Co-Location and the Provider-Based Rules – No News is…Good News? On July 15, the Centers for Medicare & Medicaid Services ("CMS") released the 2023 Outpatient Prospective Payment System proposed rule (“OPPS Proposed Rule”),…more

Centers for Medicare & Medicaid Services (CMS), Critical Access Hospitals, Health Care Providers, Health Insurance, Healthcare

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NLRB General Counsel Takes Aim at Non-Competition Agreements

The General Counsel of the National Labor Relations Board (“NLRB”) set her sights on a new target with the latest memorandum: non-competition agreements. The memorandum, while not binding, lays out the General Counsel’s belief…more

Employer Liability Issues, Employment Contract, NLRA, NLRB, NLRB General Counsel

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Federal Contractor COVID-19 Vaccine Mandate Looks to Return, With Potential Updates

As we previously reported, on August 26, 2022, the U.S. Court of Appeals for the Eleventh Circuit issued a decision narrowing the nationwide injunction against the COVID-19 vaccination mandate for federal contractor employees…more

Biden Administration, Coronavirus/COVID-19, Emergency Management Plans, Employer Liability Issues, Employer Mandates

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CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S…more

Centers for Medicare & Medicaid Services (CMS), Comment Period, FDA Approval, Food and Drug Administration (FDA), Innovative Technology

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Breaking News: Missouri Supreme Court Abandons "Exclusive Causation" Standard For Workers' Compensation Retaliation

The Missouri Supreme Court ruled Tuesday that plaintiffs claiming workers' compensation retaliation need only prove that their workers' compensation claims were a "contributing factor" to any adverse employment action. The April…more

Adverse Employment Action, Burden of Proof, Disability Discrimination, Discrimination, Employer Liability Issues

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HHS Finalized Part 2 Revisions: What Has Changed?

On February 8, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), released final rule (Final Rule)…more

CARES Act, Department of Health and Human Services (HHS), Final Rules, Health Care Providers, Health Insurance Portability and Accountability Act (HIPAA)

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Supreme Court Rejects Government's FCA Implied Certification Theory

The Supreme Court of the United States in Universal Health Services, Inc. v. Escobar et al., weighed in on and embraced the implied certification theory of liability within the False Claims Act (FCA)…more

False Claims Act (FCA), False Implied Certification Theory, Federal Contractors, Health Care Providers, Implied Certification

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SEC Division of Examinations Announces 2022 Examination Priorities

Each year, the U.S. Securities and Exchange Commission’s (SEC) Division of Examinations (Division) prioritizes the examination of certain practices, products and services that it believes present potentially heightened risks to…more

Anti-Money Laundering, Capital Formation, Capital Markets, Investor Protection, Regulatory Agenda

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Wolf in Sheep’s Clothing: Bitclub Network Promoter Admits to Securities Fraud and Tax Offenses

Joseph Frank Abel recently pled guilty to conspiring to offer and sell unregistered securities and to filing a false tax return in connection with his role in the BitClub Network, a cryptocurrency mining scheme worth at least…more

Bitcoin, Bitcoin Mining, Criminal Conspiracy, Criminal Prosecution, Cryptocurrency

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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The Strategic Role of Systematic Health Care M+A in Remaking the Future of Health Care

This white paper analyzes the interplay of those middle market health care business mergers and acquisitions with the four-part, patient-care-centric conceptual framework of ownership, organization, payment and delivery that we…more

Acquisition Agreements, Business Model, Corporate Sales Transactions, Due Diligence, Health Care Providers

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The FAR Council’s Implementation of the “No TikTok on Government Devices Act” - Applicability, Limited Exceptions and the FAR Council’s Expectation of Impact of the Rule

Background - In December of 2022, Congress passed the “No TikTok on Government Devices Act” as part of the Consolidated Appropriations Act, 2023 to address the risks presented by the app to sensitive government data. This law…more

China, Consolidated Appropriations Act (CAA), Data Collection, Federal Acquisition Regulations (FAR), Federal Bans

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Estate Planning Impact Of The Secure Act

The ‘Setting Every Community Up for Retirement Enhancement’ Act (the “SECURE Act”) was signed into law on December 20, 2019 and became effective January 1, 2020…more

401k, 403(b) Plans, Beneficiary Designations, Compensation & Benefits, Employee Benefits

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Blockchain+ Bi-Weekly - May 2024

Big news dropped in the past few weeks, which sent shockwaves across the industry: according to a recently filed lawsuit, the SEC has classified the second largest cryptocurrency, Ether, as a security in certain ongoing…more

Blockchain, Cryptocurrency, Digital Assets, Digital Wallets, Investment Opportunities

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Navigating State and Local Laws Implicated by Remote Workforces

As we start to come out of the pandemic, many businesses are deciding to embrace remote workforces on a more permanent basis for a variety of reasons, including cost saving, increased talent pool, and employee satisfaction…more

Employees, Employer Liability Issues, Employment Policies, Local Ordinance, Minimum Wage

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News for Contractors and Construction Lenders in Arizona and Nevada – The Contractors' Lien May Trump the Bank's

In addition to an arid climate and plenty of sunshine, Arizona and Nevada have something more to offer contractors: a potentially advantageous position over lenders when a project goes bad. When a project derails and…more

Banks, Construction Contracts, Construction Defects, Construction Disputes, Construction Liens

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Hospital Medicare Certification at Risk? CMS Clarifies Inpatient Volume Expectations

Hospitals with dangerously low inpatient volume and micro hospitals focused primarily on the delivery of outpatient and/or emergency room services instead of inpatient services beware: CMS (Centers for Medicare and Medicaid…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Hospitals, Inpatient Billing, Medical Certification Requests

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The 80/20 Rule is Here: CMS Finalizes HCBS Care Worker Payment Requirements

In May 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a series of rule changes intended to help promote the availability of home and community-based services (“HCBS”) for Medicaid beneficiaries. Chief…more

Centers for Medicare & Medicaid Services (CMS), Compensation & Benefits, Fair Labor Standards Act (FLSA), Health Care Providers, Healthcare Workers

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Department of Labor Issues Guidance on New PUMP Act

On December 29, 2022, President Biden signed the Providing Urgent Maternal Protections (“PUMP”) for Nursing Mothers Act into law. The law went into effect immediately, as we previously reported.  The United States Department of…more

Breastfeeding, Employee Rights, Employees, Employer Liability Issues, Field Assistance Bulletins

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Medicare Continues its Updates to Provider Enrollment Policies as Part of Efforts to Enhance Program Integrity and Transparency

The Centers for Medicare & Medicaid Services (“CMS”) continued its efforts to increase oversight of the Medicare program by updating Medicare provider enrollment regulations and policies through recent regulatory and…more

Centers for Medicare & Medicaid Services (CMS), Enrollment, Health Care Providers, Health Insurance, Healthcare

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Easement Fund Victory on Perpetuity Will Result in More Attention on Valuation

In the latest victory for taxpayers, the Tax Court determined that the Treasury failed to follow federal law in enacting a conservation easement perpetuity rule known as the “proceeds regulation.” The majority opinion held that…more

Charitable Donations, Conservation Easements, Internal Revenue Code (IRC), IRS, Property Owners

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USPTO Publishes Substantive Changes to PTAB Rules

On April 1, 2016 the USPTO published the final rules that make substantive changes to the Patent Trial and Appeal Board (PTAB) trial practice rules for inter partes review (IPR), covered business method (CBM), and post-grant…more

America Invents Act, Covered Business Method Proceedings, Inter Partes Review (IPR) Proceeding, Patent Trial and Appeal Board, Patents

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Minimum Wages Increase in States Across the Country

With the New Year, employers should make sure that they are up to date on the minimum wage laws applicable to their employees. As of January 1, 2019, the minimum wage has increased in the following 19 states..…more

Employer Liability Issues, Minimum Wage, New Legislation, Popular, State and Local Government

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The Mystery of Express Couriers and Missing Entries in ACE

A little known fact to a lot of importers is how the big three express couriers (FedEx, UPS and DHL) typically file their import entries.  In order to expedite clearances, they use a fuzzy interpretation of the import…more

Brokers, Couriers, Cross-Border Transactions, Customs and Border Protection, Delivery Drivers

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How to Get a PTAB Decision Designated Precedential

This past year, we have seen the Patent Trial and Appeal Board (PTAB) designate a number of decisions as precedential and informative more so than in past years. This is directly a result of the USPTO’s revised Standard…more

Administrative Proceedings, Intellectual Property Protection, Patent Trial and Appeal Board, Patents, Post-Grant Review

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Cybersecurity To-Dos in 2023

Introduction - The cybersecurity threat landscape continues to evolve and present new challenges pertaining to the protection of electronically stored information. Innovative “hacking” tactics constantly emerge and…more

Business E-Mail Compromise (BEC), Cyber Attacks, Cyber Crimes, Cybersecurity, Data Breach

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2024 OFCCP Contractor Portal for Affirmative Action Plan Certification Opened April 1, 2024

The Office of Federal Contract Compliance Programs (OFCCP) announced that the Contractor Portal for federal contractors and subcontractors to certify compliance with their affirmative action plan (AAP) obligations opened on…more

Affirmative Action, Certification Requirements, Employer Liability Issues, Federal Contractors, Federal Labor Laws

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Blockchain+ Bi-Weekly - May 2024

Big news dropped in the past few weeks, which sent shockwaves across the industry: according to a recently filed lawsuit, the SEC has classified the second largest cryptocurrency, Ether, as a security in certain ongoing…more

Blockchain, Cryptocurrency, Digital Assets, Digital Wallets, Investment Opportunities

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Highly Anticipated Proposed EEOC Guidance May Force Design Changes on Existing Wellness Programs

On Monday, the Equal Employment Opportunity Commission ("EEOC") published much anticipated proposed regulations amending Americans with Disabilities Act ("ADA") regulations on employer wellness programs. Specifically, the EEOC…more

Americans with Disabilities Act (ADA), Biometric Information, Disability Discrimination, Equal Employment Opportunity Commission (EEOC), Health Insurance Portability and Accountability Act (HIPAA)

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The Privacy Survival Guide - July 2019

Polsinelli is pleased to share The Privacy Survival Guide. This newsletter is a designated source of news, information and guidance on the constantly evolving health care privacy industry. …more

Biometric Information, Biometric Information Privacy Act, California Consumer Privacy Act (CCPA), Consumer Privacy Rights, Data Collection

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Optum Seeks Massive Clawback of Medicare Advantage Plan Payments

Recently, Optum Behavioral Health (“Optum,” the services division for UnitedHealth Group) has initiated overpayment recovery actions against numerous licensed clinical social workers (“LCSWs”) across the country for services…more

Centers for Medicare & Medicaid Services (CMS), Clawbacks, Health Care Providers, Medicare Advantage, Overpayment

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Fireworks Are Coming Before Independence Day

Mark your calendars for July 3—the date we will likely learn whether a Texas Court will enjoin the FTC Rule banning non-competes from taking effect on September 4. This week, Judge Ada Brown, the presiding judge in Ryan, LLC v…more

Competition, Confidential Information, Employer Liability Issues, Employment Contract, Federal Labor Laws

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FERC Proposes Changes to PURPA Regulations

On September 19, 2019, the Federal Energy Regulatory Commission (FERC) issued a Notice of Proposed Rulemaking (NOPR) that outlines potentially significant changes to FERC’s regulations implementing the Public Utility Regulatory…more

Comment Period, FERC, Notice of Proposed Rulemaking (NOPR), PURPA, Qualifying Facility

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FTC Final Rule Banning Most Non-Competes Passes – What Nonprofits Need to Know

On April 23, 2024, the Federal Trade Commission (“FTC”) conducted a special Open Commission Meeting to vote on a Final Rule (the “Rule”) banning most non-compete clauses as an “unfair method of competition.” By a vote of 3-2,…more

501(c)(3), Competition, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC)

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Court Decides Take-Home Exposure Duty Claims with 'Wide-Ranging Impact'

Employers and premises owners have a duty to "members of a worker's household" to exercise ordinary care to prevent take-home asbestos exposures, the California Supreme Court held on December 1, 2016. This ruling expands…more

Asbestos, Asbestos Litigation, CA Supreme Court, Take-Home Exposure, Toxic Exposure

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60-Day Overpayment Reporting Final Rule—The Rule of Six

On February 12, 2016, CMS published the Reporting and Returning of Overpayments Final Rule (Final Rule). The Final Rule takes effect on March 14, 2016. Overall, CMS appears to have listened to stakeholders and acknowledged their…more

60-Day Rule, Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Medicare, Medicare Part A

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Update: SEC Releases Long-Awaited Proposed Crowdfunding Rules

In This Issue: - Requirements and Obligations Governing Crowdfunding Offerings - Regulation of Crowdfunding Portals - Additional Notable Provisions of the Proposed Rules - Next Steps - For More Information…more

Crowdfunding, Disclosure Requirements, Funding Portal, General Solicitation, JOBS Act

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CMS Makes Changes to MSSP in 2019 Physician Fee Schedule

In the 2019 Medicare Physician Fee Schedule (MPFS) final rule published on November 23, CMS published new policies for accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP)…more

ACOs, Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Medicare, Medicare Shared Savings Program

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The Future Of Patentable DNA: A Myriad Of Possibilities

In This Issue: - Summary - Case Analysis - Implications ..Prokaryotic Nucleic Acid Sequences ..Short Segments of Eukaryotic DNA ..Promoters/Regulatory regions ..Isolated Proteins …more

AMP v Myriad, DNA, Genetic Materials, Myriad, Patent-Eligible Subject Matter

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The Legacy IRA Act Meets the EARN Act: A Gift or a Lump of Coal

Generally, donors who are over the age of 70 ½ can direct distributions to be made from their individual retirement account (IRA) of up to $100,000 per year to public charities (other than to fund a donor advised fund). This…more

Charitable Rollover, Employee Benefits, Individual Retirement Account (IRA), IRA Rollovers, Proposed Legislation

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A Watershed Moment for Business, Industry, and Agriculture: EPA Releases Final Clean Water Rule

On May 27, 2015, the United States Environmental Protection Agency ("EPA") and Army Corps of Engineers jointly released a final rule clarifying what bodies of water are subject to federal jurisdiction under the Clean Water Act…more

Agricultural Land, Clean Water Act, Environmental Protection Agency (EPA), Flood Zones, Mining

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New Executive Order Revises Buy American Requirements

On January 25, 2021, President Biden issued an Executive Order on Ensuring the Future Is Made in All of America by All of America’s Workers (the “EO”). The purpose of the EO is to strengthen “Made in America Laws,” which include…more

Biden Administration, Buy America, Executive Orders, Federal Acquisition Regulations (FAR), Federal Contractors

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Florida Legal Update: Laws of Interest Effective July 1, 2020

Business Legal Updates - Collegiate Student Athletes Can Now Receive Compensation - With the passing of Section 1006.74, F.S., effective July 1, 2020, intercollegiate athletes at a “postsecondary educational institution”…more

Assisted Living Facilities (ALFs), Fiduciary Duty, FinTech, Florida, Foreign Corporations

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Understanding Blockchain and Its Role in Global Supply Networks

By now, bitcoin has become a household name. The idea of a digital, unregulated “cryptocurrency” elicits strong responses. Some have heralded bitcoin as revolutionary…more

Blockchain, Distributed Ledger Technology (DLT), Popular, Supply Chain, Technology

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Department of Labor Provides Model Subsidized COBRA Notices and Additional Guidance

As described in our March 15, 2021 update, the American Rescue Plan Act of 2021 (the “Act”) created a temporary, 100% subsidy for assistance-eligible individuals’ premium payments for continuation health care coverage under the…more

American Rescue Plan Act of 2021, Biden Administration, COBRA, Coronavirus/COVID-19, EBSA

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COVID-19 Washington Update - 3.20.20

Last night, Senate Republicans released a third economic stimulus package (S. 3548) that includes loans for strategically important industries, tax relief for families and businesses, direct financial support for individuals and…more

Coronavirus/COVID-19, Financial Stimulus, Healthcare, Relief Measures, Small Business

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Biden’s October 30, 2023, Executive Order on AI: Key Takeaways for Health Care Stakeholders

The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI has…more

Artificial Intelligence, Health Information Technologies, Health Insurance Portability and Accountability Act (HIPAA), Healthcare, HITECH Act

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Surviving the Retail Shift: Part 3 of a 5 Part Series - Coping with Retail Closures and the Evolution of the Shopping Center, Balancing Creative Uses with Co-Tenancy Provisions

Shopping centers are not dying. The retail landscape is changing, however, and so too are shopping centers. Retail stores have been closing at a breakneck pace, and Wall Street seems to think the worst is yet to come. Investors…more

Co-Tenants, Commercial Leases, Commercial Tenants, Contract Terms, Retail Market

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Federal Circuit Addresses Obviousness of Polymorphs in Grunenthal GmbH v. Alkem Labs. Ltd., No. 2017-1153 (Fed. Cir. Mar. 28, 2019)

For the first time, on March 28, 2019, the Federal Circuit addressed obviousness of polymorph claims based on a known approach to polymorph screening, finding no reasonable expectation of success…more

Hatch-Waxman, Intellectual Property Litigation, Intellectual Property Protection, Obviousness, Pharmaceutical Industry

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Startups, Know This About Open Source Before Incorporating It into Your Products

The use of open source to develop new software products is widespread among technology startups, to the point that there are over 25 million repositories on GitHub, over 430,000 projects on SourceForge and over 21 billion lines…more

Business Development, Open Source Software, Popular, Software Developers, Startups

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Federal Judge Overturns Part B Payment Cuts to the 340B Drug Discount Program

A federal district court granted a permanent injunction against the Medicare Part B 2018 Outpatient Prospective Payment System (“OPPS”) payment cuts for separately payable, non-pass through drugs purchased through the 340B Drug…more

Department of Health and Human Services (HHS), Health Care Providers, Health Insurance, Hospitals, Low-Income Issues

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Northern District Federal Court Orders Presumptive Eligibility for Medicaid Applicants for Long Term Care Services

A recent ruling by Judge Gotschall in the United States District Court for the Northern District of Illinois, Eastern Division made it abundantly clear that the state has 90 days to bring its procedures for processing Medicaid…more

Class Action, Class Certification, Eligibility, Health Care Providers, Health Insurance

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What’s up with Illinois’ BIPA

The Illinois Biometric Information Privacy Act, 740 ILCS 14/1 through 14/99, was enacted in 2008 to manage the promise of biometric technology for Illinois residents. BIPA seeks to encourage the development and use of biometric…more

Biometric Information, Biometric Information Privacy Act, BNSF Railway, Data Collection, Data Privacy

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What’s New for 2023? The Latest Round of Workplace Developments for 2023 and Beyond

The California State Legislature adjourned on August 31, 2022. Following the adjournment, several bills with significant implications for employers were presented to Governor Newsom for signature or veto by September 30, 2022…more

Bereavement Leave, California, Coronavirus/COVID-19, Employees, Employer Liability Issues

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New Proposed Requirements for Prop 65 Warnings Create Potentially Significant Implications for Businesses Across the Country

The California Office of Environmental Health Hazard Assessment (OEHHA) recently sent out a notice regarding proposed rulemaking to repeal the existing regulations that govern the provision of clear and reasonable warnings under…more

Employer Mandates, NPRM, OEHHA, Proposition 65, Safe Drinking Water Act

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Congress, CMS Seek Input on Provider-Based Reimbursement Reductions

Late last year, Congress made sweeping changes to Medicare provider-based reimbursement that virtually shut down any future off-campus, provider-based site developments. Section 603 of the Bipartisan Budget Act of 2015 (BBA)…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, OPPS, Physician Medicare Reimbursements

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Department of the Treasury Issues New Advisory Regarding Ransomware Payments

On September 21, 2021, the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”) released its Updated Advisory on Potential Sanctions Risks for Facilitating Ransomware Payments (the “Updated Advisory”)…more

Corporate Counsel, Cyber Attacks, Cyber Crimes, Cybersecurity, Data Breach

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Polsinelli Podcast - Business Litigation Survival Guide

If you own a business the reality is that one day you will likely face a lawsuit. That may mean a lawsuit you have to bring to enforce an agreement or protect your company, or one you have to defend against a disgruntled…more

Employer Liability Issues

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SBA New Final Rule Establishes Accrual SBIC License and Implements Significant Changes to SBIC Regulations

The Small Business Administration (the “SBA”) published a final rule on July 18, 2023, implementing significant changes to reduce barriers to program participation and address Small Business Investment Company (“SBIC”)…more

Capital Investments, Capital Requirements, Debentures, Final Rules, SBA

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Brexit Prompts IP Uncertainty

It's difficult to turn on the news and not hear something about the historic vote by Britain to leave the European Union. While the Brexit vote already has had an immediate effect on global economic markets, the legal effects in…more

Community Trade Mark Regulation (CTM Regulation), EFTA, EU, European Economic Area (EEA), European Patent Office

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The SEC Raises the Stakes: New Cybersecurity Rules for Publicly Traded Companies Hit the Books in 2023

In 2023, the U.S. Securities and Exchange Commission (“SEC”) issued its now-fully implemented Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure Rule. The Rule reflects the reality that cybersecurity is…more

Corporate Governance, Cyber Attacks, Cyber Incident Reporting, Cybersecurity, Disclosure Requirements

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Revisiting Government March-In Rights Under Bayh-Dole: The FTC Weighs In

On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute of…more

Bayh-Dole Act, Draft Guidance, Drug Pricing, Federal Trade Commission (FTC), Healthcare

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President Trump Bans Entry of Certain Temporary Foreign Workers, Extends “Green Card” Ban Through 2020

President Trump has issued a new Executive Order extending the current ban on immigrant visas for those outside the United States, as well as barring entry of new classes of nonimmigrant visas, namely H-1B, H-2B, L, and J visas…more

Coronavirus/COVID-19, Foreign Workers, Green Cards, H-1B, H-2B

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Copyright Term Reduction Act, Part 2: Let’s Party Like It's 1909

As an extension of an effort spearheaded by Senator Josh Hawley (R-Missouri) last year, the Copyright Clause Restoration Act of 2023 (H.R.576) was recently introduced in the U.S. House of Representatives by U.S. Rep. Greg Steube…more

Berne Convention, Content Strategy, Copyright, Copyright Infringement, Fifth Amendment

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Senate to Debate Fairness in Class Action Litigation Act

A piece of federal legislation reflects a significant effort by Congress to curb perceived abuses of the federal class action procedure. The legislation is the Fairness in Class Action Litigation Act of 2017 – on March 9…more

Attorney's Fees, Class Action, Class Certification, Conflicts of Interest, Disclosure Requirements

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Supreme Court Confirms the AIA On-Sale Bar Covers Secret Sales—But Invites Controversy over What Is “Otherwise Available to the Public.”

The Supreme Court recently issued its closely-watched decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., which has direct implications regarding the scope of § 102 prior art under the America Invents Act…more

America Invents Act, Appeals, Assignment of Inventions, Confidentiality Agreements, Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc

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FDA Publishes Industry Guidance Document for Amendments to Abbreviated New Drug Applications

In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A…more

Abbreviated New Drug Application (ANDA), Generic Drugs, Hatch-Waxman, Intellectual Property Protection, Life Sciences

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New York Targets Real Estate Owners in New LLC Transparency Law

Riding a wave of ownership disclosure laws began with the passage of the federal Corporate Transparency Act (CTA), on December 22, 2023, Governor Hochul signed New York’s own “LLC Transparency Act” (the NY-LLCTA), passed by the…more

Anti-Money Laundering, Beneficial Owner, Corporate Transparency Act, Financial Crimes, FinCEN

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Illinois Supreme Court Allows Remote Jury Selection

The Illinois Supreme recently entered an Order allowing for immediate remote jury selection in an attempt to alleviate the COVID-19 pandemic’s enormous impact on the court system. See In re: Illinois Courts Response to COVID-19…more

Coronavirus/COVID-19, Infectious Diseases, Judicial Proceedings, Jury Selection, Jury Trial

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The Polsinelli Pulse: Mitigating Litigation Risk at the Deal Table and Beyond - Vol. 3

Mergers & Acquisitions And Paycheck Protection Program: Proceed With Caution - In Spring 2020, Congress adopted the CARES Act, which authorized $350 billion for the Paycheck Protection Program (“PPP”). With an additional $310…more

Acquisition Agreements, C-Suite Executives, CARES Act, Coronavirus/COVID-19, Cyber Insurance

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Reopening the Economy and Getting Back to Business: Privacy Concerns with Health Data Collection and Contact Tracing

As we continue our series on steps business owners should take to mitigate the risk of reopening, it is clear from the guidance that has been issued by several states that effective screening and contact tracing are issues that…more

California Consumer Privacy Act (CCPA), Contact Tracing, Coronavirus/COVID-19, Cybersecurity, Data Collection

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Artificial Intelligence Has a NIST Framework for Cybersecurity Risk

On May 3rd,  Lina Khan, the Chair of the Federal Trade Commission, made clear that the FTC is well equipped to handle the issues brought to the fore by the A.I. sector, “including collusion, monopolization, mergers, price…more

Antitrust Provisions, Artificial Intelligence, Cybersecurity, Data Protection, Federal Trade Commission (FTC)

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Lying to Regulators … What’s The Risk?

In one of the most high-profile cases of its time, Martha Stewart was convicted of obstructing justice as a result of her intentional misrepresentation to Securities and Exchange Commission and FBI investigators regarding the…more

Brokers, False Statements, FBI, Investigations, Lying

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FDA 2023-24: A Look Back & A Peek Forward

Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased…more

Artificial Intelligence, Baby Products, FDA Approval, Food and Drug Administration (FDA), Healthcare

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FDA 2023-24: A Look Back & A Peek Forward

Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased…more

Artificial Intelligence, Baby Products, FDA Approval, Food and Drug Administration (FDA), Healthcare

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The 80/20 Rule is Here: CMS Finalizes HCBS Care Worker Payment Requirements

In May 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a series of rule changes intended to help promote the availability of home and community-based services (“HCBS”) for Medicaid beneficiaries. Chief…more

Centers for Medicare & Medicaid Services (CMS), Compensation & Benefits, Fair Labor Standards Act (FLSA), Health Care Providers, Healthcare Workers

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Congress Takes Steps to Prioritize Youth Mental Health

Recognizing the urgent need to increase access to mental health and substance use services for young people, Congress is taking significant legislative steps to strengthen the federal government’s response to the nationwide…more

Healthcare, Healthcare Reform, HRSA, Mental Health, Prescription Drugs

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The Polsinelli Pulse: Mitigating Litigation Risk at the Deal Table and Beyond - Vol. 3

Mergers & Acquisitions And Paycheck Protection Program: Proceed With Caution - In Spring 2020, Congress adopted the CARES Act, which authorized $350 billion for the Paycheck Protection Program (“PPP”). With an additional $310…more

Acquisition Agreements, C-Suite Executives, CARES Act, Coronavirus/COVID-19, Cyber Insurance

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Are You Ready? Starting August 1st, New York Imposes New Review Process for Material Transactions Involving Health Care Entities

On May 3, 2023, New York Governor Kathy Hochul signed into law Article 45-A, amending the New York Public Health Law (“Article 45-A”). Under this new Article 45-A, health care entities in New York State are now required to…more

Acquisition Agreements, Covered Transactions, Disclosure Requirements, Health Insurance, Healthcare

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U.S. Supreme Court Again Rules for Arbitration, Rejecting Judge-Made Doctrine That Gave Courts Authority to Reject Arbitration

In yet another win for businesses seeking to shift the forum for their disputes from the courtroom to the conference room, the U.S. Supreme Court this week unanimously decided an important case that makes it easier to compel…more

Appeals, Arbitration, Arbitration Agreements, Arbitrators, Contract Terms

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CMS Issues Proposed Rule Reform for Long Term Care Facilities - Part 1 of 4

On July 13, 2015, CMS issued a proposed rule to reform the requirements for long term care facilities participating in Medicare and Medicaid. The 400-page proposed rule recommends the biggest overhaul to nursing home…more

Centers for Medicare & Medicaid Services (CMS), Compliance, Department of Health and Human Services (HHS), Healthcare, Long Term Care Facilities

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SEC Adopts Amendments to MD&A and Other Financial Disclosure Requirements in Regulation S-K

On November 19, 2020, the Securities and Exchange Commission (the “SEC”) adopted final rule amendments to modernize, simplify, and enhance Management’s Discussion & Analysis of Financial Condition and Results of Operations…more

Corporate Governance, Disclosure Requirements, Financial Regulatory Reform, Financial Statements, MD&A Statements

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Cyber Security: Are You At Risk?

In This Issue: - Prevention - Notification - Potential Litigation - Conclusion - Excerpt from Foreward: As the recent Target and Neiman Marcus data breaches made clear, cyber security is one of…more

Cybersecurity, Cybersecurity Framework, Data Breach, Data Breach Plans, Data Protection

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California Takes the Lead in Regulating the Internet of Things

After just recently enacting the broadest United States privacy law, the California Consumer Privacy Act of 2018, California took the lead once again by enacting a law for the Security of Connected Devices, commonly known as the…more

Connected Items, Consumer Privacy Rights, Cybersecurity, Data Collection, Hackers

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The SEC Raises the Stakes: New Cybersecurity Rules for Publicly Traded Companies Hit the Books in 2023

In 2023, the U.S. Securities and Exchange Commission (“SEC”) issued its now-fully implemented Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure Rule. The Rule reflects the reality that cybersecurity is…more

Corporate Governance, Cyber Attacks, Cyber Incident Reporting, Cybersecurity, Disclosure Requirements

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American Health Care Act in the U.S. House of Representatives

On January 13th, Congress passed the Fiscal Year 2017 Budget Resolution (S. Con. Res. 3) which included reconciliation instructions for the House Committees on Energy and Commerce and Ways and Means and the Senate Committees on…more

Affordable Care Act, Cadillac Tax, Congressional Budget Office, Employer Mandates, Health Insurance

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Ascension of Telemedicine

In the wake of Covid-19, telehealth and telemedicine exploded as agents of change in the delivery of health care. Covid-19 forced health care providers to adapt to a “new normal” which consequently fostered a newfound interest…more

Acquisition Agreements, Coronavirus/COVID-19, Digital Health, Fee-for-Service, Infectious Diseases

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Automatic Animation Software Method Found Patentable under 35 U.S.C. § 101

Since the Supreme Court's decision two years ago in Alice v. CLS Bank, courts and the U.S. Patent and Trademark Office have found a large percentage of software and computer-related inventions to claim abstract ideas and not be…more

Abstract Ideas, Animation, CLS Bank v Alice Corp, Computer-Related Inventions, Enfish v Microsoft

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IRS Identifies Monetized Installment Sales as a Listed Transaction

On August 4, 2023, the IRS published proposed regulations that, if finalized, would identify monetized installment sale transactions as a listed transaction. Sellers, intermediaries and other involved parties would be required…more

Installment Agreements, Internal Revenue Code (IRC), IRS, Proposed Regulation, Purchase Agreement

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Simon says “Don’t Close Your Stores in My Shopping Centers”

Simon Property Group is at it again. Two years ago, Simon took the shopping center world by storm when it obtained an injunction preventing Starbucks Corporation from shuttering 77 of its Teavana stores in Simon malls across the…more

Abercrombie & Fitch, Business Closures, Commercial Leases, Commercial Tenants, Contract Terms

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Maryland Joins Trend Requiring Salary and Wage Disclosures in Job Listings

Effective October 1, 2024, Maryland will become the sixth state (plus the District of Columbia), to require that employers provide an upfront disclosure of the wage or salary range for open positions in job listings. The new law…more

Disclosure Requirements, Employer Liability Issues, Hiring & Firing, Job Ads, Job Applicants

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Changes Coming To Prescription Drug Advertising

FDA Developing New Risk and Benefit Perception Scale - On April 21, 2014, continuing its scrutiny of the disclosures of risks and benefits in prescription drug advertising, FDA announced a plan to conduct a study…more

Advertising, Food and Drug Administration (FDA), Prescription Drugs

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Reimbursement and Payor Dispute Update

Strategies for Complying with Price Transparency and Surprise Billing Laws - State legislatures and the federal government have been busy the past 12 months churning out laws that impose new disclosure and billing obligations on…more

Coronavirus/COVID-19, Health Care Providers, Health Insurance, Healthcare Reform, Infectious Diseases

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Provider-Based Update: Congress Offers Encouraging Step to Reduce Scope of BBA Reimbursement Reductions

On Wednesday, members of the House Ways and Means Health Subcommittee introduced bipartisan legislation that would provide some welcome relief to hospitals who had already invested resources to develop new provider-based…more

Bipartisan Budget, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Hospitals

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New Legislation Overhauls State and Local Regulations for Commercial Wind and Solar Farms

On January 27, 2023, Governor Pritzker signed a bill that will transform the way counties and municipalities in Illinois locally regulate the development and construction of commercial wind and solar energy generation…more

Energy Projects, Energy Reform, Illinois, Infrastructure, New Legislation

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Lender's Edge Newsletter: May 2017

Deeds in Escrow - Deeds in escrow, or “pocket deeds,” have increased in popularity in recent years. But are they the right option in connection with a workout of your distressed loan? …more

Banking Sector, Consumer Financial Protection Bureau (CFPB), Consumer Lenders, Deeds, Escrow Accounts

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PTAB Issues Updates to the AIA Trial Practice Guide

The Patent Trial and Appeal Board (PTAB) has just issued an update to the American Invents Act (AIA) Trial Practice Guide incorporating the Board’s current practices and providing further explanation of certain aspects of the…more

America Invents Act, Patent Infringement, Patent Litigation, Patent Trial and Appeal Board, Patents

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New Legislative Action on "Tip Pooling"

Congress and the President have waded in to the ongoing debate regarding employers’ use of “tip pools” under the Fair Labor Standards Act (“FLSA”) by passing the Tip Income Protection Act (“TIPA”) as part of the omnibus spending…more

Department of Labor (DOL), Employer Liability Issues, Fair Labor Standards Act (FLSA), Food Service Workers, Minimum Wage

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Taking InsurTech on the Road: Mobile App Bumps and Solutions

As insurers, agencies, producers and service companies seek to become more efficient and competitive in the InsurTech marketplace, offering mobile apps seems to be one obvious solution…more

Data Security, Insurance Industry, Mobile Apps, Popular, Regulatory Standards

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Protecting Viable Private Equity Investment In The Insurance Sector

In This Issue: - M&A Activity in the Insurance Industry - Developments in the M&A Regulatory Environment - NAIC Private Equity Issues (E) Working Group - The Working Group’s Proposals Subject to Comment …more

Casualty Insurance, Insurance Brokers, Insurance Industry, NAIC, Private Equity

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Telehealth: CMS Proposes to Discontinue Audio-Only E/M Services and Virtual Direct Supervision in 2023 Proposed Rule

On July 07, 2022 the Centers for Medicare and Medicaid Services (“CMS”) released the 2023 Physician Fee Schedule (“PFS”) Proposed Rule, which proposes several significant changes to Medicare telehealth services…more

Centers for Medicare & Medicaid Services (CMS), Comment Period, FQHC, Health Care Providers, Health Insurance

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Employers Must Prep for New EEOC Data Reporting Rule

Employers who thought that they had received a respite from the U.S. Equal Employment Opportunity Commission’s proposed requirement to report information about employees' pay and hours worked when submitting their annual EEO-1…more

Data Collection, EEO-1, Employment Discrimination, Equal Employment Opportunity Commission (EEOC), Equal Pay

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What is the Impact of the FTC’s Final Non-Compete Rule on Franchisors and Franchisees?

As explained in Polsinelli’s prior alert of April 24, 2024, the FTC announced its final rule on non-compete covenants (the “Rule”) on April 23, 2024. Critically, the Rule does not prohibit non-compete agreements between…more

Competition, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC), Franchisee

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Draft Guidance: Pharmacy Compounding Of Human Drug Products Under Section 503A Of The Federal Food, Drug, And Cosmetic Act

Following enactment of the Drug Quality and Security Act last month, FDA has quickly issued a new guidance for compounding pharmacies that choose to not register as "outsourcing facilities" and subject themselves to federal…more

Drug Compounding, Food and Drug Administration (FDA), Pharmaceutical Industry, Pharmacies, Prescription Drugs

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Department of Labor Provides Model Subsidized COBRA Notices and Additional Guidance

As described in our March 15, 2021 update, the American Rescue Plan Act of 2021 (the “Act”) created a temporary, 100% subsidy for assistance-eligible individuals’ premium payments for continuation health care coverage under the…more

American Rescue Plan Act of 2021, Biden Administration, COBRA, Coronavirus/COVID-19, EBSA

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COVID-19 and Its Growing Impact on Commercial Contracts: How Should Contracting Parties Respond?

COVID-19 is causing a rapidly evolving public health crisis, and businesses face uncertainty about their commercial relationships. That uncertainty is raising questions about performance under contractual agreements that were…more

Business Interruption, China, Commercial General Liability Policies, Commercial Insurance Policies, Commercial Loans

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Med-Staff Newsletter - April 2019 | VOL 2

Polsinelli is pleased to share the Med-Staff Quarterly Newsletter. This publication contains articles and insight into issues that affect the Med-Staff industry. …more

Defamation, False Claims Act (FCA), Health Care Providers, Healthcare Workers, Hospitals

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Health Reform + Related Health Policy News - October 2013

In This Issue: - Top News ..Judge Orders $237.4 Million Penalty Against Tuomey for Stark Law and False Claims Act Violations ..Glitches and Demand Lead to Marketplace Frustration ..HHS Delays Small…more

Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), False Claims Act (FCA), Food and Drug Administration (FDA)

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Department of Labor Settles with TPA to End Cross-Plan Offsetting Practice

The U.S. Department of Labor (“DOL”) recently entered into a settlement agreement with a New York-based insurer and third-party administrator (“Company”) of employer group health plans governed by the Employee Retirement Income…more

Department of Labor (DOL), EBSA, Employee Benefits, Employee Retirement Income Security Act (ERISA), Employer Group Health Plans

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Biden Administration Unveils New Outbound Investment Security Program, Which Will Prohibit U.S. Investments in China Relating to Certain Technologies

On August 9, 2023, the Biden Administration took the first significant steps towards implementing a new regime to restrict and regulate U.S. investments in certain Chinese technology sectors. The President released an Executive…more

Advanced Notice of Proposed Rulemaking (ANPRM), Artificial Intelligence, Biden Administration, China, Executive Orders

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Lender's Edge Newsletter: May 2017

Deeds in Escrow - Deeds in escrow, or “pocket deeds,” have increased in popularity in recent years. But are they the right option in connection with a workout of your distressed loan? …more

Banking Sector, Consumer Financial Protection Bureau (CFPB), Consumer Lenders, Deeds, Escrow Accounts

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SEC Adopts Changes to Regulation D and Intrastate Offerings and Proposes Use of “Universal Proxy Cards” in Contested Director Elections

On Oct. 26, the Securities and Exchange Commission adopted final rules increasing the threshold for offerings made under Rule 504 of Regulation D and broadening the intrastate offering exemption afforded by Rule 147. These…more

Disclosure Requirements, Offerings, Proxy Voting Guidelines, Publicly-Traded Companies, Regulation D

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SEC Division of Examinations Announces 2022 Examination Priorities

Each year, the U.S. Securities and Exchange Commission’s (SEC) Division of Examinations (Division) prioritizes the examination of certain practices, products and services that it believes present potentially heightened risks to…more

Anti-Money Laundering, Capital Formation, Capital Markets, Investor Protection, Regulatory Agenda

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“36-Month Rule” Anticipated to Expand to Hospice

On July 10, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Rule that would extend the “36-Month Rule” to Hospice providers. The 36-Month Rule refers to 42 C.F.R. § 424.550(b), which currently…more

Centers for Medicare & Medicaid Services (CMS), Change of Ownership, Comment Period, Enrollment, Healthcare

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Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

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Navigating FMLA: May An Employee Be Entitled to Leave Beyond 12 Weeks?

In certain circumstances, an employee may begin a leave of absence prior to being eligible to take leave pursuant to the Family and Medical Leave Act (“FMLA”)…more

Eligibility, Employer Liability Issues, Family and Medical Leave Act (FMLA), Leave of Absence, Medical Leave

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The 80/20 Rule is Here: CMS Finalizes HCBS Care Worker Payment Requirements

In May 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a series of rule changes intended to help promote the availability of home and community-based services (“HCBS”) for Medicaid beneficiaries. Chief…more

Centers for Medicare & Medicaid Services (CMS), Compensation & Benefits, Fair Labor Standards Act (FLSA), Health Care Providers, Healthcare Workers

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USPTO’s New Electronic Grant System Shortens the Time to File Continuing Applications

On April 18, 2023, the United States Patent and Trademark Office (“USPTO”) updated the patent grant system to an electronic patent grant (“eGrant”) system. Previously, the USPTO issued patent grants to patent applicants via…more

Corporate Counsel, Electronic Filing, Grants, Intellectual Property Protection, Patent Applications

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Equal Employment Opportunity Commission Issues Final Guidance on Workplace Harassment

On April 29, 2024, the Equal Employment Opportunity Commission (“EEOC”) issued final guidance on workplace harassment. The guidance is effective immediately and is the first time the EEOC has updated its workplace harassment…more

Employer Liability Issues, Equal Employment Opportunity Commission (EEOC), Final Rules, Labor Reform, LGBTQ

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Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

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Polsinelli Represents Water Authority in Bond Refunding of San Diego County Water Authority Desalination Project Pipeline

Polsinelli attorneys recently represented the San Diego County Water Authority in the sale of $183,155,000 in refunding bonds for the Claude “Bud” Lewis Carlsbad Desalination Project Pipeline…more

Bonds, Desalination, Infrastructure, Investment Opportunities, Public Private Partnerships (P3s)

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FDA Preemption of State Law for False Labeling Survives Appeal to Supreme Court

Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision…more

Denial of Certiorari, Dietary Supplements, False Advertising, Federal Food Drug and Cosmetic Act (FFDCA), Food & Drug Regulations

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Health Care Reimbursement and Payor Dispute Update Special Edition - Year End Regulatory Review

The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like…more

Ambulatory Surgery Centers, Centers for Medicare & Medicaid Services (CMS), Drug Pricing, Health Care Providers, Health Insurance

See all updates »

Evaluating AI Framework – A Tool for GCs

Introduction   The interest and requests for guidance on artificial intelligence (“AI”) tools exploded in early 2023, with the publicity and public launch of powerful and easily applied generative AI tools. With the spotlight…more

Artificial Intelligence, Automation Systems, Data Privacy, Innovative Technology, Machine Learning

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District of Columbia Provides Employment Protections for Off-Duty Cannabis Use

On June 7, 2022, the D.C. Council approved a bill that limits an employer’s ability to test for cannabis.  Under the Cannabis Employment Protections Amendment Act, most D.C. employers may not fire, fail to hire, or take other…more

Adverse Employment Action, Decriminalization of Marijuana, Employee Rights, Employer Liability Issues, Labor Reform

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Delaware Courts Continue to Clarify Creditor Standing With Respect to Insolvent Companies

On May 4, 2015, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery issued an opinion in Quadrant Structured Products Company, Ltd. v. Vertin clarifying when a creditor gains standing to pursue derivative claims…more

Commercial Bankruptcy, Creditors, Derivative Suit, Fiduciary Duty, Insolvency

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More Signs of Trouble for Non-Compete Agreements

Non-compete agreements have had a rough 2023, most recently with President Biden specifically calling them out on Tuesday evening during his State of the Union and emphasizing his Administration’s opposition to them.  This, of…more

Anti-Competitive, Biden Administration, Employer Liability Issues, Employment Contract, Former Employee

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Don't Be Left On The Sidelines: CMS Is Seeking Applications For A New Hospice Demonstration Program

Currently, Medicare patients that wish to receive palliative hospice care have a tough choice to make—forgo any curative treatment or incur all hospice care costs. This could change, however, with the recent launch of CMS's…more

Centers for Medicare & Medicaid Services (CMS), Healthcare, Healthcare Reform, Hospice, Hospitals

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FTC Settles Privacy Shield Misrepresentation Claims

The Federal Trade Commission recently entered into settlement agreements with four companies regarding claims that the companies misrepresented their compliance with the EU-U.S. Privacy Shield Framework…more

Certification Requirements, Enforcement Actions, EU, EU-US Privacy Shield, Federal Trade Commission (FTC)

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October PFAS Regulatory Update

In October 2023, the United States Environmental Protection Agency (EPA) finalized two separate but analogous rulemakings – one under the Toxic Substances Control Act (TSCA), and one under the Emergency Planning and Community…more

Contamination, Drinking Water, Environmental Policies, EPCRA, Hazardous Substances

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The Future Of Patentable DNA: A Myriad Of Possibilities

In This Issue: - Summary - Case Analysis - Implications ..Prokaryotic Nucleic Acid Sequences ..Short Segments of Eukaryotic DNA ..Promoters/Regulatory regions ..Isolated Proteins …more

AMP v Myriad, DNA, Genetic Materials, Myriad, Patent-Eligible Subject Matter

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Ownership Transparency Continues for Skilled Nursing Facilities with Additional Required Disclosures

On November 15, 2023, CMS finalized a proposed rule that will require Skilled Nursing Facilities (“SNFs”) to disclose the identity of an expanded array of ownership and control interests in SNFs beyond the information that is…more

Beneficial Owner, Centers for Medicare & Medicaid Services (CMS), Corporate Transparency Act, Disclosure Requirements, Health Care Providers

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SEC Division of Examinations Announces 2022 Examination Priorities

Each year, the U.S. Securities and Exchange Commission’s (SEC) Division of Examinations (Division) prioritizes the examination of certain practices, products and services that it believes present potentially heightened risks to…more

Anti-Money Laundering, Capital Formation, Capital Markets, Investor Protection, Regulatory Agenda

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George Costanza and the Supreme Court Align in Ruling This Week on Section 11 of the Securities Act of 1933

In a classic Seinfeld episode, George Costanza opined: "it's not a lie, if you believe it". In a ruling handed down on March 24th, the Supreme Court agreed with this sentiment as it concerned claims brought under Section 11 of…more

Material Misstatements, Omnicare v Laborers District Council, Registration Statement, SCOTUS, Securities Act of 1933

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Designers, Contractors and Insurers Take Note: Recent Amendment to IL Statute of Repose Strips Asbestos Defense, Exposes Decades of Liability

On December 19, 2014 the Illinois legislature amended the Illinois construction statute of repose to eliminate its protection in asbestos exposure cases (Public Act 098-1131). Beginning June 1, 2015, design professionals and…more

Amended Regulation, Asbestos, Construction Industry, Statute of Repose

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CMS “Goes Fishing” on Stark Law’s Impediments to Value-Based, Coordinated Care

On June 20, 2018, the Centers for Medicare & Medicaid Services and Department of Health and Human Services issued a “request for information” (RFI) seeking input on strategies to reduce the burden of the federal physician…more

Alternative Payment Models (APM), Centers for Medicare & Medicaid Services (CMS), Fee-for-Service, Health Care Providers, Request For Information

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Texas’ Third Special Legislative Session Ends Without Any Expansion of Governor Abbott’s “Vaccine Mandate Ban” Executive Order

Texas’ Third Special Session ended on October 19, 2021 without the Texas Legislature codifying any law related to Governing Abbott’s recent Executive Order (GA-40), which prohibits entities (including private employers and…more

Coronavirus/COVID-19, Employer Liability Issues, Employer Mandates, Executive Orders, Governor Abbott

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Mandatory Arbitration Agreements Remain Valid in California

California employers received welcome reassurance last week that they are free to require employees enter into arbitration agreements as a condition of employment. This is the result of an opinion from the Ninth Circuit last…more

Arbitration, Arbitration Agreements, California, Employment Contract, Federal Arbitration Act

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Pregnant Pause: U.S. Supreme Court Reinstates Pregnancy Discrimination Suit Against UPS

In a case that garnered significant attention from employers prior to hearing, the U.S. Supreme Court created by a 6-3 vote a new approach for proving and defending against pregnancy discrimination and accommodation cases…more

Disparate Treatment, PDA, Pregnancy Discrimination, Reasonable Accommodation, SCOTUS

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Simon says “Don’t Close Your Stores in My Shopping Centers”

Simon Property Group is at it again. Two years ago, Simon took the shopping center world by storm when it obtained an injunction preventing Starbucks Corporation from shuttering 77 of its Teavana stores in Simon malls across the…more

Abercrombie & Fitch, Business Closures, Commercial Leases, Commercial Tenants, Contract Terms

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The Supreme Court in Van Buren Decision Limits the Scope of the Computer Fraud and Abuse Act

Van Buren v. United States, ­No. 19-783, 2021 WL 2229206 (U.S. 2021) - Overview - On June 3, 2021, the Supreme Court issued an opinion reversing the Eleventh Circuit’s holding that former police sergeant Nathan Van Buren had…more

Computer Fraud and Abuse Act (CFAA), Databases, Police, SCOTUS, Unauthorized Access

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New Developments in Hatch-Waxman Personal Jurisdiction Cases

The United States District Court for the Southern District of Indiana joined the District of Delaware and the Eastern District of Texas in finding specific jurisdiction based on receipt of a Paragraph IV Notice Letter. See Eli…more

Hatch-Waxman, Patent Infringement, Patent Litigation, Patents, Personal Jurisdiction

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Hospital Medicare Certification at Risk? CMS Clarifies Inpatient Volume Expectations

Hospitals with dangerously low inpatient volume and micro hospitals focused primarily on the delivery of outpatient and/or emergency room services instead of inpatient services beware: CMS (Centers for Medicare and Medicaid…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Hospitals, Inpatient Billing, Medical Certification Requests

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Financial Wellness Initiatives - Student Loan Debt Returns to Center Stage: Practical Considerations for Adding a Match for Student Loan Payments

The burden of student loan debt is an ever-present challenge for our former post-high school students.   As you probably know, President Biden had proposed a student debt forgiveness plan that was projected to relieve as much as…more

Consumer Financial Products, Debt Relief, Employee Benefits, Employee Contributions, Employer Contributions

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FTC Settles Privacy Shield Misrepresentation Claims

The Federal Trade Commission recently entered into settlement agreements with four companies regarding claims that the companies misrepresented their compliance with the EU-U.S. Privacy Shield Framework…more

Certification Requirements, Enforcement Actions, EU, EU-US Privacy Shield, Federal Trade Commission (FTC)

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HRSA Aims for Swift Dispute Resolution with new 340B ADR Final Rule

On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers…more

Claim Procedures, Covered Entities, Dispute Resolution, Drug Pricing, Healthcare

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NASAA Shuts Down Use of Acknowledgments and Questionnaires in Franchise Sales Process

The North American Securities Administrators Association, Inc. (“NASAA”) has just adopted a new policy regarding the use of franchise questionnaires and acknowledgments in the franchise sales process. In its Statement of Policy…more

Franchise Disclosure Document, Franchise Laws, Franchisee, Franchises, NASAA

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The SEC Adopts Amendments to Modernize Regulation S-K Disclosure Requirements

On August 26, 2020, for the first time in over 30 years, the Securities and Exchange Commission (the “SEC”) adopted significant amendments to the Regulation S-K disclosure requirements regarding the description of a reporting…more

Corporate Governance, Disclosure Requirements, Financial Regulatory Reform, Publicly-Traded Companies, Regulation S-K

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So You Want to Arbitrate a Chose in Action Obtained Through an ABC?

The Court of Chancery for the State of Delaware recently issued a ruling affirming the ability of assignees in assignments for the benefit of creditors (ABCs) to assert claims against third parties originally held by the…more

ABC, Arbitration, Assignees, Commercial Bankruptcy, Transfer of Interest

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Med-Staff Publication - September 2018

Polsinelli is pleased to share the Med-Staff Quarterly Publication. This newsletter contains articles and insight into issues that affect the Med-Staff industry. …more

Credentialing, Drug & Alcohol Abuse, Health Care Providers, Healthcare Facilities, Healthcare Workers

See all updates »

SEC Proposes Changes to Modernize and Simplify Equity Compensation Rules and Registration Obligations

On November 24, 2020, the Securities and Exchange Commission (“SEC”) proposed amendments to Rule 701 and Form S-8 (the “Proposals”) under the Securities Act of 1933, as amended (the “Securities Act”)…more

Disclosure Requirements, Form S-8, Publicly-Traded Companies, Rule 701, Securities and Exchange Commission (SEC)

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Missouri Protects Health Care Providers from Civil Actions Relating to COVID-19 Exposure

On July 7, 2021, Missouri Governor Mike Parson signed SB 51 into law, which protects health care providers from being held liable in civil actions for COVID-19 exposure (the “Act”)…more

Civil Liability, Coronavirus/COVID-19, Health Care Providers, Immunity, Infectious Diseases

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Don't Be Left On The Sidelines: CMS Is Seeking Applications For A New Hospice Demonstration Program

Currently, Medicare patients that wish to receive palliative hospice care have a tough choice to make—forgo any curative treatment or incur all hospice care costs. This could change, however, with the recent launch of CMS's…more

Centers for Medicare & Medicaid Services (CMS), Healthcare, Healthcare Reform, Hospice, Hospitals

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BitBlog Weekly Update

This BitBlog summary focuses on the continuing actions by the U.S. Securities and Exchange Commission (“SEC”) against the issuers of noncompliant initial coin offerings (“ICOs”) and other crypto related transactions including…more

Bitcoin, CFTC, Commodities, Cryptocurrency, Default Judgment

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Academic Medical Centers and the Broad Reach of Title IX: Castro, et al. v. Yale University, et al.

A recent case brought by female physicians against Yale University highlights the difficulty of disentangling an academic medical center from a university when assessing the reach of Title IX of the Education Amendment Act of…more

Civil Rights Act, Healthcare Facilities, Physicians, Sex Discrimination, Teaching Hospitals

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Potential Legal Frameworks for DAOs

An interesting and thoughtful whitepaper called “A Legal Framework for Decentralized Autonomous Organizations” was co-authored by a general counsel of one of the major venture investors in the blockchain space suggesting a…more

Blockchain, Corporate Structures, Cryptocurrency, Decentralized Finance (DeFi), Liability

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The Devil's Dictionary of Bankruptcy Terms: Fraudulent Transfer

Fraudulent Transfer: A transfer by the debtor (including the incurring of an obligation by the debtor) voidable under Section 548 or under state law imported into the bankruptcy case through Section 544…more

Bankruptcy Code, Commercial Bankruptcy, Fraudulent Transfers, UFTA

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New Discovery Order Requiring Greater Transparency Regarding Bankruptcy Trust Claims in Southern California Asbestos Litigation

On May 27, 2015, the Honorable Emilie H. Elias, the coordination judge who presides over all asbestos litigation in the counties of Los Angeles, Orange, and San Diego (LAOSD), issued a discovery order entitled “Case Management…more

Asbestos, Asbestos Litigation, Commercial Bankruptcy, Discovery, Interrogatories

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Colorado Supreme Court to Rule on Yet Another Key Construction Defects Issue

On July 5, 2016, the Colorado Supreme Court announced it will consider the construction defects case of Forest City Stapleton, Inc., et al. v. Rogers. In this case the Colorado Court of Appeals, for the first time, imposed an…more

CO Supreme Court, Construction Defects, Construction Industry, Construction Litigation, Construction Project

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SEC Adopts Cybersecurity Incident and Risk Management Disclosure Rules

On July 26, 2023, the Securities and Exchange Commission (the “SEC”) adopted new rules requiring public companies to disclose within four business days material cybersecurity incidents they experience and to disclose annually…more

Cyber Attacks, Cybersecurity, Data Breach, Data Protection, Data Security

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Fireworks Are Coming Before Independence Day

Mark your calendars for July 3—the date we will likely learn whether a Texas Court will enjoin the FTC Rule banning non-competes from taking effect on September 4. This week, Judge Ada Brown, the presiding judge in Ryan, LLC v…more

Competition, Confidential Information, Employer Liability Issues, Employment Contract, Federal Labor Laws

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Member of an Arizona LLC? You May Have a Fiduciary Duty to the LLC

Arizona has finally resolved the issue of whether managers and members of an Arizona Limited Liability Company (LLC) owe a common law fiduciary duty to the LLC and whether an operating agreement can lawfully limit those…more

AZ Supreme Court, Business Litigation, Common Law Torts, Contract Terms, Duty of Care

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Texas Bellwether Case Affirms the Legality of an Employer’s Mandatory Vaccination Policy

Over the weekend, the U.S. Southern District of Texas issued an order that provides employers—at least in Texas—with greater certainty about the legality of mandatory vaccination policies…more

Americans with Disabilities Act (ADA), Coronavirus/COVID-19, Corporate Counsel, Employer Liability Issues, Employment Policies

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Recent Amendments to State Breach Notification Laws

Over the last several months, a minority of states amended their data breach notification statutes or enacted sector-specific breach notification requirements…more

Amended Regulation, Cyber Attacks, Cybersecurity, Data Breach, Data Protection

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The Strategic Role of Systematic Health Care M+A in Remaking the Future of Health Care

This white paper analyzes the interplay of those middle market health care business mergers and acquisitions with the four-part, patient-care-centric conceptual framework of ownership, organization, payment and delivery that we…more

Acquisition Agreements, Business Model, Corporate Sales Transactions, Due Diligence, Health Care Providers

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Fireworks Are Coming Before Independence Day

Mark your calendars for July 3—the date we will likely learn whether a Texas Court will enjoin the FTC Rule banning non-competes from taking effect on September 4. This week, Judge Ada Brown, the presiding judge in Ryan, LLC v…more

Competition, Confidential Information, Employer Liability Issues, Employment Contract, Federal Labor Laws

See all updates »

New Licensing and Regulatory Requirements for Pharmacy Benefit Managers in Ohio

House Bill 64 recently amended Ohio Revised Code Chapter (ORC) 3959. The relevant code sections amended by House Bill 64 are ORC 3959.111 and ORC 3959.12 and these changes took effect on September 29, 2015. Pursuant to…more

Compliance, Healthcare, Pharmacies

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California Bill SB 642 Will Not Move Forward This Year

On May 20, 2021, the California Senate Appropriations Committee placed Senate Bill 642 (“SB 642”) on the “2-year” bill list, meaning that the proposed legislation will not move forward in the current legislative session…more

Health Care Providers, Hospitals, Private Equity Firms, State and Local Government

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Brexit and Its Effect on European Union Trademarks

As you may be aware, the transition period for Brexit and the withdrawal of the United Kingdom from the European Union likely ends on December 31, 2020. The completion of the withdrawal initiated February 1, 2020, will have an…more

Domain Names, EU, European Union Trade Mark (EUTM), Intellectual Property Protection, Trademark Registration

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Update on Term SOFR and Practical Considerations for Usage

On July 29, 2021, the Alternative Reference Rates Committee of the Federal Reserve Bank of New York (the “ARRC”) officially recommended for usage the forward-looking SOFR term rates (collectively, “Term SOFR”) published by the…more

Alternative Reference Rates Committee (ARRC), Financial Institutions, Interest Rates, Libor, Secured Overnight Funding Rate (SOFR)

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MACRA: Proposed Changes to the Merit-Based Incentive Payment System Track

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on the Medicare Quality Payment Program (QPP) in the Federal Register1 on June 30, 2017. This rule proposes the QPP program requirements for calendar…more

CEHRT, Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Medicare, Medicare Access and CHIP Reauthorization (MACRA)

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A Spoonful of Sugar Helps With Regulation Financial Stability Board (FSB) Consultation on Global Stablecoins

In Mary Poppins the magical nanny tells the children in her charge that “a spoonful of sugar helps the medicine go down.” In the spirit of helping the medicine of regulation go down, the FSB has published for consultation 10…more

Cryptocurrency, Financial Instruments, Financial Markets, FinTech, FSB

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Are You Being Served? Court Authorizes Service of Process Via Airdrop

In what may be the first of its kind, a New York state court has authorized service via token airdrop in a case regarding allegedly stolen cryptocurrency assets. This form of alternative service is novel but could become a more…more

Blockchain, Crypto Exchanges, Cryptocurrency, Digital Assets, Digital Wallets

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Conflict Minerals Disclosure Compliance

The SEC has adopted a rule requiring SEC reporting companies to provide disclosures about conflict minerals that are "necessary to the functionality or production of a product manufactured by the company." Conflict minerals…more

Conflict Mineral Rules, Disclosure Requirements, Securities and Exchange Commission (SEC)

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Feds Two-Step on Texas Sovereignty has Far-Reaching Compliance Implications

The recent federal grand jury indictment of 21 health care executives, investors, and physicians in connection with the now defunct Dallas-based Forest Park Medical Center effectively turned the Texas health care compliance…more

Bribery, Department of Justice (DOJ), Federal Health Care Programs (FHCP), Health Care Providers, Healthcare

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COVID-19 Washington Update - 3.20.20

Last night, Senate Republicans released a third economic stimulus package (S. 3548) that includes loans for strategically important industries, tax relief for families and businesses, direct financial support for individuals and…more

Coronavirus/COVID-19, Financial Stimulus, Healthcare, Relief Measures, Small Business

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Lender's Edge Newsletter: January 2018

Are Lenders Entitled to Insurance Proceeds When Foreclosing? A lender’s right to insurance proceeds after foreclosure depends on the type of loss payable clause contained in the insurance policy and the timing of the loss…more

Financial Services Industry, Foreclosure, Insurance Industry, Lenders, Mortgages

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Don't be Fooled by the Name... The Small BREW Act Could Have a Big Impact on Craft Breweries

The Small Brewer Reinvestment and Expanding Workforce Act, known as the "Small BREW Act", is bipartisan legislation introduced to Congress in early 2015. The overall goal of the Small BREW Act is to revamp the federal excise tax…more

Beer, Breweries, Business Taxes, Federal Taxes, Popular

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Renewable News - Spring 2013

In This Issue: - Federal Policy Update - TradeWind and Alabama Power Announce PPA for Kansas Project - NextEra Energy Resources Finalized Purchase of Kansas Project - Incentives Announced for $66 Million…more

Biofuel, Energy Projects, Renewable Energy, Wind Power

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Minimum Wage Increase for Employees of Florida Medicaid Providers

On June 2, 2022, Governor DeSantis signed the “Freedom First Budget” for Fiscal Year 2022-2023 for the sole purpose of increasing the minimum wage for employees and independent contractors of Medicaid providers to at least…more

American Health Care Act (AHCA), Employees, Employer Liability Issues, Fee-for-Service, Florida

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Biden’s October 30, 2023, Executive Order on AI: Key Takeaways for Health Care Stakeholders

The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI has…more

Artificial Intelligence, Health Information Technologies, Health Insurance Portability and Accountability Act (HIPAA), Healthcare, HITECH Act

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Florida Legislative Session 2024: Health Care Highlights

The Florida Regular Legislative Session began on January 9, 2024, and ended on March 8, 2024. Below is a summary of relevant health care laws that will be effective July 1, 2024, if they are approved by Governor DeSantis…more

Cancer, Employee Benefits, Florida, Health Care Providers, Health Insurance

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Contractors: Be on the Lookout to Challenge Unreasonable Agency Procurements

Since government agencies are given substantial discretion in creating solicitations and evaluating proposals, contractors are frequently at a disadvantage in identifying and challenging improprieties. But that discretion is not…more

Defense Sector, Federal Contractors, GAO, Procurement Guidelines, SBA

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Turning the Tables in Class Action Discovery: Conducting Merits Discovery Prior to Class Certification Remains a Viable Defense Strategy

Class actions often are lengthy and costly undertakings for defendants, and the discovery process can demand the most significant amount of resources. When discovery on class certification issues is then followed by merits…more

Class Action, Class Certification, Defense Strategies, Discovery, FRCP 23

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Opportunity Zone Deadlines Extended By COVID-19 Disaster Declarations (UPDATED)

On January 19, 2021, the IRS published guidance in Notice 2021-10, extending critical deadlines and rules relating to investments in qualified opportunity zones. First, any investors facing a deadline between April 1, 2020, and…more

Capital Gains, Community Development, Coronavirus/COVID-19, Economic Development, Infectious Diseases

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Jury Sides with Hermès in Pivotal NFT Trademark Case

On February 8, 2023, a federal jury awarded Hermès International and Hermès of Paris, Inc. (“Hermès”) $133,000 in its trademark lawsuit against designer Mason Rothschild. Hermès sued Rothschild for selling non-fungible tokens…more

Artistic Works, Cybersquatting, Digital Assets, Dilution, Fashion Branding

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2024 OFCCP Contractor Portal for Affirmative Action Plan Certification Opened April 1, 2024

The Office of Federal Contract Compliance Programs (OFCCP) announced that the Contractor Portal for federal contractors and subcontractors to certify compliance with their affirmative action plan (AAP) obligations opened on…more

Affirmative Action, Certification Requirements, Employer Liability Issues, Federal Contractors, Federal Labor Laws

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'Fiduciary Rule' Update: Financial Services Industry Should Prepare for Compliance

The U.S. Department of Labor (DOL) scored an initial victory in what is sure to be a long legal battle over the so-called "fiduciary rule." Judge Randolph D. Moss of the U.S. District Court for the District of Columbia issued a…more

Annuities, Broker-Dealer, Employee Benefits, Fiduciary Duty, Fiduciary Rule

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Tech Transactions & Data Privacy 2021 Report

As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired…more

Artificial Intelligence, California Consumer Privacy Act (CCPA), Communications Decency Act, Contact Tracing, COPPA

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Health Reform + Related Health Policy News - October 2013

In This Issue: - Top News ..Judge Orders $237.4 Million Penalty Against Tuomey for Stark Law and False Claims Act Violations ..Glitches and Demand Lead to Marketplace Frustration ..HHS Delays Small…more

Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), False Claims Act (FCA), Food and Drug Administration (FDA)

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Hydrocarbon Tax Policy Trends

As governments focus on clean energy and carbon reduction initiatives, their oil and gas taxation policies have increasingly come under scrutiny. Polsinelli’s attorneys review a few overarching themes concerning expected trends…more

Carbon Pricing, Energy Policy, Gas Royalties, Hydrocarbons, Infrastructure

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Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787…more

Abbreviated New Drug Application (ANDA), America Invents Act, Generic Drugs, Hatch-Waxman, Intellectual Property Protection

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Biosimilars: Strategic Considerations for 2018

2017 was an eventful year for biosimilars in the U.S. As the number of biosimilar filings increased, important legal and regulatory decisions changed the strategic landscape of the biosimilars market for both innovators and…more

Amgen, Biologics, Biosimilars, BPCIA, Food and Drug Administration (FDA)

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The Proposed Build Back Better Act Moves Forward After the House Passes a Revised Version of the Bill

Overview - Over the past year, several tax law changes have been proposed by the Biden administration and, in September 2021, draft legislative language was circulated, which set forth proposed changes to the Internal…more

Biden Administration, Capital Gains Tax, Corporate Taxes, Foreign Derived Intangible Income (FDII), Foreign Tax Credits

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2014 Top Energy & Environmental Regulatory Issues

In This Issue: - Environmental Protection Agency ..NAAQS ..Tier 3 & 4 Standards ..Stormwater Control ..Hydraulic Fracturing Regulation ..Clean Water Act Expansion ..Renewable Fuels…more

Carbon Capture and Sequestration, Carbon Emissions, Clean Water Act, Department of Energy (DOE), Department of the Interior

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SEC Adopts Cybersecurity Incident and Risk Management Disclosure Rules

On July 26, 2023, the Securities and Exchange Commission (the “SEC”) adopted new rules requiring public companies to disclose within four business days material cybersecurity incidents they experience and to disclose annually…more

Cyber Attacks, Cybersecurity, Data Breach, Data Protection, Data Security

See all updates »

New Jersey Continues to Expand Worker Protections – New Protections for Misclassified Workers; New Potential Liability

In addition to bolstering the provisions of its mini-WARN Act (see Part I), New Jersey Governor Phil Murphy also recently signed into law expansive provisions aimed at deterring worker misclassification…more

Anti-Retaliation Provisions, Employee Definition, Employer Liability Issues, Fines, Freelance Workers

See all updates »

Med-Staff Publication - September 2018

Polsinelli is pleased to share the Med-Staff Quarterly Publication. This newsletter contains articles and insight into issues that affect the Med-Staff industry. …more

Credentialing, Drug & Alcohol Abuse, Health Care Providers, Healthcare Facilities, Healthcare Workers

See all updates »

A Watershed Moment for Business, Industry, and Agriculture: EPA Releases Final Clean Water Rule

On May 27, 2015, the United States Environmental Protection Agency ("EPA") and Army Corps of Engineers jointly released a final rule clarifying what bodies of water are subject to federal jurisdiction under the Clean Water Act…more

Agricultural Land, Clean Water Act, Environmental Protection Agency (EPA), Flood Zones, Mining

See all updates »

The Applicability of Anti-Fraud Rules to Certain Statements and Information made by Obligated Persons of Municipal Securities – A Legal Bulletin ‘Reminder’ from the Office of Municipal Securities

On February 7, 2020, the Securities and Exchange Commission’s (the “SEC”) Office of Municipal Securities released its Legal Bulletin No. 21 (the “Bulletin”) regarding the applicability of the anti-fraud provisions of the federal…more

Anti-Fraud Provisions, Disclosure Requirements, Investment Opportunities, Municipal Securities Issuers, Municipal Securities Market

See all updates »

USPTO’s New Electronic Grant System Shortens the Time to File Continuing Applications

On April 18, 2023, the United States Patent and Trademark Office (“USPTO”) updated the patent grant system to an electronic patent grant (“eGrant”) system. Previously, the USPTO issued patent grants to patent applicants via…more

Corporate Counsel, Electronic Filing, Grants, Intellectual Property Protection, Patent Applications

See all updates »

COVID-19 and Its Growing Impact on Commercial Contracts: How Should Contracting Parties Respond?

COVID-19 is causing a rapidly evolving public health crisis, and businesses face uncertainty about their commercial relationships. That uncertainty is raising questions about performance under contractual agreements that were…more

Business Interruption, China, Commercial General Liability Policies, Commercial Insurance Policies, Commercial Loans

See all updates »

The Applicability of Anti-Fraud Rules to Certain Statements and Information made by Obligated Persons of Municipal Securities – A Legal Bulletin ‘Reminder’ from the Office of Municipal Securities

On February 7, 2020, the Securities and Exchange Commission’s (the “SEC”) Office of Municipal Securities released its Legal Bulletin No. 21 (the “Bulletin”) regarding the applicability of the anti-fraud provisions of the federal…more

Anti-Fraud Provisions, Disclosure Requirements, Investment Opportunities, Municipal Securities Issuers, Municipal Securities Market

See all updates »

FTC Final Rule Banning Most Non-Competes Passes – What Nonprofits Need to Know

On April 23, 2024, the Federal Trade Commission (“FTC”) conducted a special Open Commission Meeting to vote on a Final Rule (the “Rule”) banning most non-compete clauses as an “unfair method of competition.” By a vote of 3-2,…more

501(c)(3), Competition, Employer Liability Issues, Employment Contract, Federal Trade Commission (FTC)

See all updates »

Can You Discriminate Against a Company's Race? Fourth Circuit Says Yes, Grants Standing to Sue for Racial Discrimination

Owners, contractors and other recipients of federal funds be aware: when construction or other federally-funded contracts sour, not only can contracting parties file lawsuits claiming breach of contract, but if the contracting…more

Construction Industry, Discrimination, Federal Contractors, Minority-Owned Businesses, Public Financing

See all updates »

Congress Approves The American Taxpayer Relief Act Of 2012, Preventing "Fiscal Cliff"

After much contention,Congress passed the American Taxpayer Relief Act of 2012, and President Obama signed the legislation on January 2, 2013. The Act avoids automatic sunset provisions that were scheduled to take effect…more

Alternative Minimum Tax, American Taxpayer Relief Act, Bush-Era Tax Cuts, Business Taxes, Capital Gains

See all updates »

Georgia is Ground Zero for Telemedicine Fraud

The United States Attorney’s Office for the Southern District of Georgia has become a leader in telemedicine fraud enforcement since 2019. Yesterday’s press release by the Department of Justice, announcing a historic nationwide…more

Department of Justice (DOJ), Enforcement Actions, Fraud and Abuse, Healthcare Fraud, Indictments

See all updates »

Loyalty-Discount Programs and the Antitrust Laws

Loyalty discounts are price reductions by a supplier in return for a customer’s commitment to purchase a certain percentage of its requirements from the supplier. Sellers also sometimes discount their prices if a customer…more

Anti-Competitive, Antitrust Provisions, Customer-Loyalty Programs, Exclusivity, Retail Market

See all updates »

Med-Staff Newsletter - October 2023 | VOL 12

Do the Right Thing — Reporting Voluntary Actions Taken While “Under Investigation” to the NPDB - Many health care entities struggle with the dilemma of whether and when to make reports to the National Practitioner Data Bank…more

Health Care Providers, Healthcare, Healthcare Reform, Healthcare Workers, Investigations

See all updates »

New Form 5500 Rules Permit More Plans to Qualify for Audit Exemption

The Department of Labor, Internal Revenue Service, and Pension Benefit Guaranty Corporation recently issued final rules on employee benefit plan annual reporting requirements that are effective for plan years beginning on or…more

401k, 403(b) Plans, Compensation & Benefits, Department of Labor (DOL), Employee Benefits

See all updates »

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JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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