Polsinelli

Regulators’ New Focus On Director And Officer Liability Insurance; Other Considerations

The Federal Deposit Insurance Corporation (the “FDIC”) issued an advisory statement on October 10, 2013, titled “Director and Officer Liability Insurance – Policies, Exclusions, and Indemnification for Civil Money…more

Corporate Officers, D&O Insurance, Directors, FDIC, Indemnification

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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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To Forgive, Divine: Tax Amnesty Program Signed Into Law

On Tuesday, April 27, 2015, Missouri Governor Jay Nixon signed House Bill 384, which creates a Tax Amnesty Program for taxes administered by the Missouri Department of Revenue. This includes state income taxes, franchise taxes,…more

Income Taxes, Sales & Use Tax, Tax Amnesty, Withholding Tax

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Phase 2 of the OCR HIPAA Audit Program Already Underway

On March 21, 2016, the Department of Health and Human Services, Office for Civil Rights (OCR) announced the launch of the long-awaited Phase 2 HIPAA Audit Program (Phase 2), and OCR activities related to Phase 2 are already…more

Business Associates, Covered Entities, FOIA, Health Care Providers, HIPAA

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CMS Proposes OPPS Reimbursement Adjustments: What Hospital Outpatient Providers Need to Know

In early July, the Centers for Medicare & Medicaid Services (CMS) proposed Hospital Outpatient Prospective Payment System (OPPS) reimbursement rule changes that will impact reimbursement payment amounts and requirements for…more

CMS, Comment Period, EHR, Electronic Medical Records, Health Care Providers

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Provider-Based Status: A Quiet Casualty of the Bipartisan Budget Act

Without fanfare or any significant discussion, the Bipartisan Budget Act (Act) contains the first legislative action related to provider-based status—and it is a sweeping action with negative financial consequences to many…more

Bipartisan Agreement, CMS, Drug Pricing, Health Care Providers, Healthcare

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Judge Endorses Extrapolation Techniques for False Claims Act Whistleblowers

In a lawsuit brought under the False Claims Act ("FCA") a federal district judge in Florida recently rejected a defendant's challenge to a statistical sampling and extrapolation methodology advanced by a qui tam plaintiff's…more

Burden of Proof, Daubert Standards, Financial Conduct Authority (FCA), Florida, Medicaid

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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

DOL, Foreign Workers, H-1B, Highly-Skilled Workers Visa, USCIS

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Mega-Mergers Highlight Risk to Health Care Providers

Consolidation in health insurance markets can injure hospitals and doctors by creating buyer-side market power that can force providers to accept below-market prices, limit patients’ access to care, and reduce innovation in…more

Aetna, Anthem Blue Cross, Anticompetitive Behavior, Antitrust Provisions, CIGNA

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Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The…more

Best Practices, Biometric Information, Cyber Attacks, Cyber Crimes, Cyber Insurance

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Can You Satisfy CRA Requirements and Still Make Money? Try SBICs

Have you considered an investment in or creating a Small Business Investment Company? Doing so may provide financial institutions with a number of benefits, including credit toward annual investment requirements under the…more

Banks, Community Reinvestment Act, Economic Development, Financial Institutions, Financing

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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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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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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, CMS, Electronic Health Record Incentives

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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, CMS, Health Care Providers, Healthcare

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IRS’s New, Optional Donor Form Causes Confusion

On September 16, 2015, the Internal Revenue Service (IRS) issued proposed regulations to provide an alternative method for substantiating charitable contribution deductions. In connection with these regulations, the IRS will…more

Charitable Deductions, Charitable Donations, IRS, Tax Deductions

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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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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, FD&C Act, FDA, Pharmaceutical Industry

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Federal Circuit Affirms Unpatentability in Much Anticipated First Review of CBM Decision

Since the America Invents Act (AIA) passed in 2012, Covered Business Method (CBM) reviews have become the Sword of Damocles hanging over the heads of non-practicing entities, also referred to as patent trolls. Many CBM reviews…more

Abstract Ideas, America Invents Act, Covered Business Method Patents, Non-Practicing Entities, Patent Infringement

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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, FTC, Hospital Mergers, Hospitals

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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 Doesn't Care Where Your Headquarters Are Located – Your Employees May Be Covered Under its New Mandatory Paid Sick Leave Act

Are you a non-California company with employees who work in California from time to time? California's Healthy Workplaces, Healthy Families Act of 2014 ("the Act") provides for mandatory paid sick leave to any employee working…more

Airlines, Collective Bargaining, Compliance, Earned Sick Time, Healthy Workplaces Healthy Families Act 2014

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Employer Immigration Information Now Available To The Public

Recent changes by the U.S. Department of Labor will make public certain information concerning their foreign national employees. On July 1, 2013, in furtherance of the Department of Labor's Open Government Initiative, the…more

DOL, Foreign Nationals, Labor Certifications

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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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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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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, CMS, Data-Sharing, Electronic Health Record Incentives

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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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Amendment Reducing Illinois Juries from 12 to 6 About to Take Effect

Courtrooms in Illinois will begin to see a new makeup of juries soon, as effective June 1, 2015, all jury cases shall be tried by a jury of six. Previously, cases in which alleged damages exceeded $50,000 were tried by a jury of…more

Amended Legislation, Jury Selection, Jury Trial, New Legislation, Statute of Repose

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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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H-1B Worksite Changes: Can Employers Expect Relief Before August 19th Deadline?

As H-1B employers scramble to create a plan of action to ensure compliance with new guidelines and interpretations surrounding H-1B workers and changes in worksite, industry leaders are calling for more temperate policy changes…more

Compliance, Employee Relocations, Filing Requirements, Foreign Workers, H-1B

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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, FTC, Hospital Mergers, Hospitals

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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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Colorado Supreme Court: Terminating an Employee for Marijuana Use Does Not Violate the Colorado Lawful Activities Statute

On June 15, 2015, the Colorado Supreme Court held that the Colorado Lawful Activity Statute does not prohibit an employer from terminating the employment of an employee for off-the-job use of medical marijuana. However, this…more

CO Supreme Court, Coats v Dish Network, Dish Network, Employment Policies, Hiring & Firing

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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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The Devil's Dictionary of Bankruptcy Terms

The "Devil's Dictionary" is a quick-reference guide for commercial lenders and other restructuring professionals. In this series, we highlight many of the buzz words found in the Dictionary and used in today's bankruptcy arena…more

Bankruptcy Code, Commercial Bankruptcy, Commercial Loans, Debt Restructuring, Lenders

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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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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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51 Flavors: A Survey of Small Estate Procedures Across the Country

Properly navigating a probate administration in any one state can be challenging enough, but often the client’s estate—and the attorney’s practice—is not so neatly confined within one state’s boundaries. Fortunately, for certain…more

Estate Planning, Probate

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Judge Endorses Extrapolation Techniques for False Claims Act Whistleblowers

In a lawsuit brought under the False Claims Act ("FCA") a federal district judge in Florida recently rejected a defendant's challenge to a statistical sampling and extrapolation methodology advanced by a qui tam plaintiff's…more

Burden of Proof, Daubert Standards, Financial Conduct Authority (FCA), Florida, Medicaid

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CRS Report To Congress On Internet Governance

On November 13, 2013, the Congressional Research Service ("CRS") issued a report to Congress entitled "Internet Governance and the Domain Name System: Issues for Congress." The focus of the report is the United States' support…more

Domain Names, gTLD, ICANN, Intergovernmental Agreements, International Trade Disputes

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Missouri Insurance Department Reaches $7.8 Million Settlement with Anthem

The Missouri Department of Insurance, Financial Institutions and Professional Registration (DIFP) recently announced that it has entered into a $7.8 million regulatory settlement with Healthy Alliance Life Insurance Co. and HMO…more

Blue Cross, Blue Shield, Health Insurance, Insurance Industry, Settlement

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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, 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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Employers: How Do Your Retirement Plans Treat Same-Sex Unions?

IRS Issues Long Awaited Guidance on Application of US v. Windsor to Retirement Plans - New IRS guidance means that action is required by employers sponsoring qualified retirement plans if the terms of the plan are…more

DOMA, Employee Benefits, Employer Liability Issues, IRS, Qualified Retirement Plans

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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, CMS, Electronic Health Record Incentives

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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, 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, CMS, Data-Sharing, Electronic Health Record Incentives

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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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Five Things to Know About CMS's Second Round of Settlements for Hospital Appeals

The Centers for Medicare and Medicaid Services (CMS) announced that beginning December 1, 2016, it is offering to settle certain inpatient-status claims to eligible hospitals willing to withdraw from the administrative appeals…more

Appeals, CMS, Healthcare, Hospitals, Inpatient Billing

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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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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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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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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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OSHA Broadens Scope of Inspections in Hospitals and Nursing Homes

On June 25, 2015, the Occupational Safety and Health Administration (OSHA) released a memorandum, entitled "Inspection Guidance for Inpatient Healthcare Settings," establishing new guidance for OSHA staff for inspections…more

Healthcare, Hospitals, Inpatient Rehab Facilities, NEP, Nursing Homes

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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

CFPB, Department of Veterans Affairs, Enforcement Actions, Fair Housing Act (FHA), FCRA

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Court Decision Makes it Easier for Plaintiffs to Pursue Claims Against Companies in Indiana

On March 2, 2016, the Indiana Supreme Court struck down Section 2 of the Indiana Product Liability Act and held that its statute of repose “does not apply to cases involving protracted exposure to an inherently dangerous foreign…more

Asbestos, Asbestos Litigation, Hazardous Substances, Mass Tort Litigation, Statute of Repose

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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, CMS, Comment Period, Data Mining, False Claims Act (FCA)

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Missouri Court Applies Borrowing Statute to Bar Illinois Asbestos Claims

In Wolfe, et al. v. Armstrong Int'l, Inc., et al., Cause No. 1522-CC11026 (Div. No. 4), the Circuit Court for the City of St. Louis, 22nd Circuit, entered an April 11, 2016, Order dismissing certain defendants from an asbestos…more

Asbestos, Asbestos Litigation, Statute of Limitations, Toxic Exposure, Wrongful Death

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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, FDA, Final Rules, Healthcare, HHS

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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, SEC

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DOL Releases Controversial Proposal, Signifying Regulatory Intent to Expand Fiduciary Standard

On April 14, 2015, the U.S. Department of Labor ("DOL") released a controversial proposal that would require financial advisors to put their clients' interests ahead of their own when recommending retirement investments…more

Comment Period, DOL, Fiduciary Duty, Financial Adviser, Proposed Regulation

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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

CMS, Contraceptive Coverage Mandate, False Claims Act (FCA), Healthcare, Hospitals

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Ignorance is Not Bliss: Get to Know the OIG FY 2016 Work Plan

The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently released its FY 2016 Work Plan, in which it identified key areas of focus for the upcoming year. Consistent with its mandate to detect…more

Enforcement Actions, False Claims Act (FCA), Healthcare, Medicaid, Medical Devices

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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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Colorado Court of Appeals Recognizes Implied Warranty of Suitability Between Master Developer and Later Purchasers

Last week, the Colorado Court of Appeals issued an opinion recognizing for the first time that a master developer may be liable to a subsequent home purchaser under an implied warranty of suitability. Rogers v. Forest City…more

Construction Industry, Homeowners, Implied Warranties, Land Developers

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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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Catching Up With the Times: CMS Reforms Long-Term Care Facility Requirements Part III

On October 4, the Centers for Medicare and Medicaid Services (CMS) published the biggest overhaul to federal long-term care regulations since 1991, and impacted facilities can immediately take steps to ensure they’re prepared…more

Affordable Care Act, CMS, Health Care Providers, Healthcare, Hiring & Firing

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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, FDA, Healthcare

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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, CFPB, Class Action

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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 Policy, Health Care Providers, Healthcare

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Employer Immigration Information Now Available To The Public

Recent changes by the U.S. Department of Labor will make public certain information concerning their foreign national employees. On July 1, 2013, in furtherance of the Department of Labor's Open Government Initiative, the…more

DOL, Foreign Nationals, Labor Certifications

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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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Illinois Supreme Court Narrows Ability for Employees to Sue for Alleged Occupational Diseases

On November 4, 2015, in the case of Folta v. Ferro Engineering, 2015 Il 118070 (2015), the Illinois Supreme Court strengthened the exclusivity provision of the Illinois Workers' Compensation Act and Illinois Occupational…more

Asbestos, IL Supreme Court, State Law Tort Claims, Workers' Compensation Claim, Workplace Hazards

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Proposed TSCA Legislation Ramps Up Safety Requirements for Manufacturers, EPA

While consumers typically believe that anything they can buy in the store has been government tested for safety, that's not always the case. The Toxic Substances Control Act (TSCA) has been in effect and essentially unchanged…more

EPA, Manufacturers, Pending Legislation, Toxic Substances Control Act (TSCA)

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NLRB Expands “Joint Employer” Definition

In a pivotal decision on August 27, the National Labor Relations Board “refined” its test for determining joint-employer status, broadening the scope of employers subject to joint collective bargaining and concerted activity…more

Browning-Ferris Industries of California Inc., Collective Bargaining, Franchisee, Franchisors, Hiring & Firing

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Short Samplings of Songs May Not Be Considered Copyright Infringement After All

The Ninth Circuit Court of Appeals just decided that sampling a song without permission does not necessarily infringe the copyright. Many artists have built careers by sampling an old song to create a new work. Until now, courts…more

Copyright Infringement, Copyright Litigation, De Minimis Claims, Digital Sampling, Music Industry

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EEOC Issues New Enforcement Guidance on Pregnancy Discrimination and Related Issues

On July 14, 2014, the Equal Employment Opportunity Commission ("EEOC"), by a 3-to-2 vote of commissioners, issued Enforcement Guidance on Pregnancy Discrimination and Related Issues (the "Guidance"), along with a question and…more

ADA, Disability, Disability Discrimination, EEOC, Employee Rights

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Supreme Court Weighs in on Defenses to Induced Infringement

Earlier this week, the Supreme Court provided much needed guidance regarding the availability of certain defenses to claims of induced infringement. Commil USA, LLC v. Cisco Systems, Inc., U.S. Supreme Court, No. 13-896, May 26,…more

Cisco v CommilUSA, Good Faith, Induced Infringement, Patent Infringement, Patent Invalidity

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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, DOL, ERISA

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First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch…more

Amgen, Biologics Price Competition and Innovation Act of 2009, Biosimilars, BPCIA, FDA

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A Cautionary Illustration of the Need for Accounting and Compliance Reviews

Embraer SA, Brazil's flagship aerospace manufacturer and a worldwide competitor across various aviation markets, experienced first-hand the scope and reach of the Foreign Corrupt Practices Act (FCPA). Embraer agreed to pay $205…more

Accounting Fraud, Aircraft Sales, Anti-Bribery, Bribery, Cooperative Compliance Regime

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Supreme Court Loosens Standard for Willful Infringement/Enhanced Damages

In a relatively rare “pro-patent” decision, the U.S. Supreme Court earlier this week unanimously overruled the Federal Circuit’s so-called Seagate standard for finding willful patent infringement and awarding enhanced damages…more

35 U.S.C. § 284, Enhanced Damages, Halo v Pulse, Octane Fitness v. ICON, Patent Infringement

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"Take-Home" Asbestos Case Decision Could have Ripple Effect

Companies facing "take-home" asbestos or other toxic tort exposure claims in Arizona, or in other jurisdictions applying Arizona law, now have a new case to cite in dispositive motions. With the Sept. 20 Arizona Court of Appeals…more

Appeals, Asbestos, Asbestos Litigation, Duty of Care, Hazardous Substances

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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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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

CFPB, Department of Veterans Affairs, Enforcement Actions, Fair Housing Act (FHA), FCRA

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If You Credit-Check New Hires, Go Over Your Disclosures or Face FCRA Exposure

Employers, beware: a recent rash of class action suits regarding Fair Credit Reporting Act (FCRA) violations, specifically regarding disclosure provisions, poses new compliance requirements for materials you distribute to…more

Class Action, Compliance, Corporate Counsel, Credit Reports, Disclosure Requirements

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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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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, Healthcare Reform, HHS, HIPAA, Medicare

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No More Long Lunches: The $18M FCA Payout for Inaccurate Recordkeeping

In 1920, U. S. Supreme Court Justice Oliver Wendell Holmes wrote that contractors "must turn square corners when they deal with the Government." That remains true today, and allegations in a recently-settled False Claims Act…more

Boeing, False Claims Act (FCA), Federal Contractors, Government Contractors, Qui Tam

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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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Multiemployer Pension Plans

In this Update Series, we provide continuing updates on the key developments relating to multiemployer pension plans, as well as practical considerations for the companies that participate in them. These union benefit funds pose…more

ERISA, IRS, MPRA, Multiemployer Plan, PBGC

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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, Fraud, 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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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

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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, CMS, Contract Terms

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Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data. The…more

Data Collection, Data Protection, Digital Health, Electronic Medical Records, Health Care Providers

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Obama Signs Omnibus Budget Bill that Includes $622 Million in Tax Extenders

On December 18, 2015, President Obama signed the Protecting Americans from Tax Hikes Act of 2015 (the “PATH Act”) after both houses of Congress voted to approve the budget measure and comprehensive spending bill. The PATH Act…more

Cadillac Tax, IRS, Protecting Americans from Tax Hikes (PATH) Act, Renewable Energy, Tax Credits

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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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Missouri Insurance Department Reaches $7.8 Million Settlement with Anthem

The Missouri Department of Insurance, Financial Institutions and Professional Registration (DIFP) recently announced that it has entered into a $7.8 million regulatory settlement with Healthy Alliance Life Insurance Co. and HMO…more

Blue Cross, Blue Shield, Health Insurance, Insurance Industry, Settlement

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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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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, Essential Health Benefits, Health Insurance Exchanges, HHS

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Update: Multiemployer Pension Plans volume 2

In This Issue: - Recent Developments for Multiemployer Pension Plans - Q & A - More Polsinelli MPRA Intelligence - MPRA Counseling Services - Excerpt from Recent Developments for Multiemployer…more

Insolvency, Multiemployer Plan, PBGC, Pensions

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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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ColoradoCare Stands to Significantly Alter Health Care Services

In November, Colorado voters will cast ballots on Amendment 69, also known as ColoradoCare. ColoradoCare is an ambitious, far-reaching plan to amend the Colorado constitution which would establish a statewide universal coverage…more

Affordable Care Act, CMS, ERISA, Health Insurance, HIPAA

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A Cautionary Illustration of the Need for Accounting and Compliance Reviews

Embraer SA, Brazil's flagship aerospace manufacturer and a worldwide competitor across various aviation markets, experienced first-hand the scope and reach of the Foreign Corrupt Practices Act (FCPA). Embraer agreed to pay $205…more

Accounting Fraud, Aircraft Sales, Anti-Bribery, Bribery, Cooperative Compliance Regime

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OPPS Provider-Based Final Rule — A More Practical Approach From CMS

CMS recently finalized sweeping changes to the way Medicare pays hospitals for services furnished in “new” off-campus provider-based departments (referred to as “off-campus PBDs”). CMS revealed the changes on November 1…more

CMS, EMTALA, FQHC, Health Care Providers, Healthcare

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High Court Spokeo Ruling on Standing Avoids Nixing No Injury Class Actions

On May 16, 2016, the United States Supreme Court released its long-awaited opinion in Spokeo, Inc. v. Robins. In a 6–2 decision, the Court remanded the case to the Ninth Circuit for further analysis of the plaintiff's…more

Article III, Class Action, FCRA, Injury-in-Fact, SCOTUS

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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, FDA, Pharmaceutical Industry, Pharmacies, Prescription Drugs

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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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Chairman Hensarling Open to Revised Financial CHOICE Act

On November 15th, House Financial Services Committee Chairman Jeb Hensarling (R-TX) signaled that he is willing to consider changes to a reintroduced Financial CHOICE Act next year as a newly elected and party-unified government…more

Banks, CFPB, Dodd-Frank, Financial Sector, Proposed Legislation

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The Devil's Dictionary of Bankruptcy Terms

The "Devil's Dictionary" is a quick-reference guide for commercial lenders and other restructuring professionals. In this series, we highlight many of the buzz words found in the Dictionary and used in today's bankruptcy arena…more

Bankruptcy Code, Commercial Bankruptcy, Commercial Loans, Debt Restructuring, Lenders

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DOJ Doubles FCA Civil Penalties

As required by last November's Bipartisan Budget Act of 2015, the Department of Justice on June 30 released an interim final rule making inflationary adjustments to civil monetary penalties under its jurisdiction, including…more

Administrative Procedure Act, Bipartisan Budget Act, Civil Monetary Penalty, DOJ, Eighth Amendment

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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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The Devil's Dictionary of Bankruptcy Terms

The "Devil's Dictionary" is a quick-reference guide for commercial lenders and other restructuring professionals. In this series, we highlight many of the buzz words found in the Dictionary and used in today's bankruptcy arena…more

Bankruptcy Code, Commercial Bankruptcy, Commercial Loans, Debt Restructuring, Lenders

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Making Sense of the MACRA Final Rule, Part 1 of 3: Essential Concepts

On Oct. 14, the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period implementing the bipartisan Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The nearly 2,400 pages of…more

ACOs, Alternative Payment Models (APM), CMS, Comment Period, Electronic Health Record Incentives

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This Article Will Self-Destruct: Your Employee’s Use of These ESI-Destroying Apps Could Subject You to Sanctions

In This Issue: - Can You Keep a Secret? There’s an App for That - Do Snapchat or Confide Produce “Documents” in the Eyes of the Law? What about Evidence? - Implications on Securities Fraud and Employment Issues…more

Corporate Counsel, Electronically Stored Information, Employer Liability Issues, Employment Policies, Evidence

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New Federal Trade Secrets Law Passed – Major Implications for Trade Secret Owners and Their Employees

Congress just passed a major revision to U.S. trade secrets law, with enactment upon the President’s signature likely in early May. Entitled the Defend Trade Secrets Act of 2016 (“DTSA”), the legislation creates for the first…more

Asset Seizure, Defend Trade Secrets Act (DTSA), Ex Parte, Intellectual Property Protection, Misappropriation

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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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Is Your Facility Ready for Ebola?

Polsinelli presents Crisis Management: a multi-part series (culminating in a webinar on 11.20.2014) on what companies must know to stay ahead of external interruption that risks serious impact to their business concerns. Second…more

CDC, Crisis Management, Ebola, Employer Liability Issues, Health Care Providers

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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, CMS, Health Care Providers, Healthcare

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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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Uber-Complicated: Insurance Challenges for Transportation Network Companies

Transportation Network Companies (TNCs) facilitate the use of personal vehicles to transport passengers for a fee using a technology based platform, such as a website or a mobile application to connect riders and drivers. The…more

Auto Insurance, Insurance Industry, Lyft, Sidecar, Transportation Network Companies

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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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Provider Alleges Retaliatory Use of Medicare Payment Suspension

A federal court has ordered discovery regarding the circumstances of a Medicare payment suspension by CMS only one week after failed settlement negotiations between a cardiology practice and the Department of Justice (DOJ) to…more

CMS, Discovery, DOJ, False Claims Act (FCA), Fraud

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Colorado Supreme Court: Terminating an Employee for Marijuana Use Does Not Violate the Colorado Lawful Activities Statute

On June 15, 2015, the Colorado Supreme Court held that the Colorado Lawful Activity Statute does not prohibit an employer from terminating the employment of an employee for off-the-job use of medical marijuana. However, this…more

CO Supreme Court, Coats v Dish Network, Dish Network, Employment Policies, Hiring & Firing

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California Doesn't Care Where Your Headquarters Are Located – Your Employees May Be Covered Under its New Mandatory Paid Sick Leave Act

Are you a non-California company with employees who work in California from time to time? California's Healthy Workplaces, Healthy Families Act of 2014 ("the Act") provides for mandatory paid sick leave to any employee working…more

Airlines, Collective Bargaining, Compliance, Earned Sick Time, Healthy Workplaces Healthy Families Act 2014

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What Hospitals Should Know About Payment Changes For 2013

In response to the government’s continued focus on improving quality of care through payment policy, several changes to new and existing regulatory requirements recently came about through the 2013 Inpatient Prospective Payment…more

CMS, Healthcare, Hospitals, Inpatient Quality Reporting, Medicare

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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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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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Most States Delayed in Implementing Long-Term Care Background Check Program, OIG Finds

The Office of Inspector General’s (OIG’s) recent report found significant delays in states’ implementation of a background check program for long-term care employees. Because the interplay between Ban the Box laws and long-term…more

Affordable Care Act, Background Checks, Ban the Box, Employer Liability Issues, Hiring & Firing

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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, FDA, Healthcare

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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, FDCA, Food Manufacturers, FSMA

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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

FDA, Food Safety, Foreign Suppliers, FSMA

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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, CMS, EHR, Exempt Organizations, Healthcare

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Supreme Court Loosens Standard for Willful Infringement/Enhanced Damages

In a relatively rare “pro-patent” decision, the U.S. Supreme Court earlier this week unanimously overruled the Federal Circuit’s so-called Seagate standard for finding willful patent infringement and awarding enhanced damages…more

35 U.S.C. § 284, Enhanced Damages, Halo v Pulse, Octane Fitness v. ICON, Patent Infringement

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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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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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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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IRS’s New, Optional Donor Form Causes Confusion

On September 16, 2015, the Internal Revenue Service (IRS) issued proposed regulations to provide an alternative method for substantiating charitable contribution deductions. In connection with these regulations, the IRS will…more

Charitable Deductions, Charitable Donations, IRS, Tax Deductions

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Employers Beware: New NLRB General Counsel Appears To Set Agenda And Expand Employee And Union Rights

On February 25, the General Counsel for the National Labor Relations Board ("NLRB"), Richard F. Griffin, issued a Memorandum which signals an effort to expand employee and union rights in twelve (12) "initiatives and policy…more

Employee Rights, NLRB, Unions

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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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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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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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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 the Interior, DOE

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The New Hart-Scott-Rodino Magic Number is $76.3 Million

The Hart-Scott-Rodino Act ("HSR") requires that transactions over a certain value be reported to the Federal Trade Commission (FTC) and U.S. Department of Justice Antitrust Division at least 30 days prior to closing. That…more

Filing Fees, FTC, Hart-Scott-Rodino Act, Jurisdiction, Premerger Notifications

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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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FDA Seeks Suggestions Regarding “Natural” Food Labeling, but Will It Act?

Surprising nearly everyone, FDA has reopened a long dormant discussion regarding the meaning of the term “natural” in the labeling of food. Today’s Federal Register contains a notice from FDA that the agency has officially…more

FDA, Food Labeling, GMO, Natural Products, Public Comment

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Regulators’ New Focus On Director And Officer Liability Insurance; Other Considerations

The Federal Deposit Insurance Corporation (the “FDIC”) issued an advisory statement on October 10, 2013, titled “Director and Officer Liability Insurance – Policies, Exclusions, and Indemnification for Civil Money…more

Corporate Officers, D&O Insurance, Directors, FDIC, Indemnification

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SCOTUS: Abercrombie's Failure to Hire Based on Assumed Religious Conflict Violates Title VII

Monday, in EEOC v. Abercrombie & Fitch Stores, Inc. the Supreme Court held that making employment decisions based on assumptions related to religion (or any other protected class for that matter) can trigger liability under…more

Abercrombie & Fitch, Disparate Treatment, EEOC, EEOC v Abercrombie, Employer Liability Issues

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Amendment Reducing Size of Illinois Juries Declared Unconstitutional

On Monday December 21st, a Cook County, Illinois trial judge declared unconstitutional the recent Illinois legislation enacted that reduced the number of jurors in all civil trials from twelve persons to six. The legislation…more

Juror 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

ADA, EEOC, Employee Benefits, Employer Group Health Plans, Genetic Discrimination

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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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Limited Time Offer! IRS Announces "Amnesty Program" for Flawed Correction of Late Annual Reports

Both the Department of Labor ("DOL") and the Internal Revenue Service ("IRS") can assess significant penalties if annual reports are not timely filed for certain retirement and health and welfare plans. However, years ago the…more

DOL, Employee Benefits, Health and Welfare Plans, Healthcare, IRS

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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, Healthcare Reform, HHS, HIPAA, Medicare

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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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CMS Proposes Amendments to Payments Furnished from Provider-Based Departments

As part of the CY 2017 proposed Hospital Outpatient Prospective Payment System rules (OPPS) the Centers for Medicare and Medicaid Services (CMS) released the long awaited proposed payment changes for items and services furnished…more

Bipartisan Budget Act, CMS, Health Care Providers, Medicare, OPPS

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New Delaware Decision Strikes Bylaw Empowering Stockholders to Remove Officers

In a case of first impression, the Delaware Court of Chancery recently struck down a provision contained in the bylaws of a Delaware corporation authorizing the corporation’s stockholders to remove a corporate officer (in the…more

CEOs, Controlling Stockholders, Corporate Officers, Delaware General Corporation Law, Fiduciary Duty

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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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First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch…more

Amgen, Biologics Price Competition and Innovation Act of 2009, Biosimilars, BPCIA, FDA

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NLRB Expands “Joint Employer” Definition

In a pivotal decision on August 27, the National Labor Relations Board “refined” its test for determining joint-employer status, broadening the scope of employers subject to joint collective bargaining and concerted activity…more

Browning-Ferris Industries of California Inc., Collective Bargaining, Franchisee, Franchisors, Hiring & Firing

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Don't Get The Summertime Blues: Properly Classifying Interns

As summer approaches, many businesses are receiving applications and requests from students for internships. In fact, many businesses have internship programs that not only offer students opportunities to increase their…more

Classification, Internships, Unpaid Interns

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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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CMS Proposes Amendments to Payments Furnished from Provider-Based Departments

As part of the CY 2017 proposed Hospital Outpatient Prospective Payment System rules (OPPS) the Centers for Medicare and Medicaid Services (CMS) released the long awaited proposed payment changes for items and services furnished…more

Bipartisan Budget Act, CMS, Health Care Providers, Medicare, OPPS

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Breaking News: Top 10 Ways the Proposed Rule Impacts Stark Law

With surprisingly little fanfare, the CY 2016 Physician Fee Schedule (the "Proposed Rule") released on July 8, 2015 proposes to add and amend several exceptions to the Physician Self-Referral Statute, commonly known as the Stark…more

CMS, Compliance, Disclosure Requirements, FQHC, Healthcare

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Chairman Hensarling Open to Revised Financial CHOICE Act

On November 15th, House Financial Services Committee Chairman Jeb Hensarling (R-TX) signaled that he is willing to consider changes to a reintroduced Financial CHOICE Act next year as a newly elected and party-unified government…more

Banks, CFPB, Dodd-Frank, Financial Sector, Proposed Legislation

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SEC Takes Aim at Anti-Whistleblower Employment Agreements

On Aug. 15, the U.S. Securities and Exchange Commission issued its second fine in six days to an employer for drafting severance agreements that restricted former employees from collecting awards as whistleblowers. The fines –…more

BlueLinx Holdings, Confidentiality Agreements, Dodd-Frank, Enforcement Actions, Health Net

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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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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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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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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

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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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, Fraud, Government Shutdown

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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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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, CMS, Health Care Providers, Medicare, Medicare Part A

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Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data. The…more

Data Collection, Data Protection, Digital Health, Electronic Medical Records, Health Care Providers

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Pharmacy Benefit Managers Face New Licensing Requirements

Two states recently enacted new pharmacy benefit manager licensing requirements that affect pharmacy benefit managers in Kentucky and New Mexico. It is important for Pharmacy Benefit Managers to ensure they are in compliance…more

Healthcare, Licenses, Pharmacies

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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

CFPB, Department of Veterans Affairs, Enforcement Actions, Fair Housing Act (FHA), FCRA

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The Future Is Now: CMS Proposes Broad Bundled Payment Expansion for Cardiac Care Episodes

Furthering the agency’s stated intention to pay for value over volume, the Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule representing the first expansion of mandatory hospital-centric bundled…more

CMS, Health Care Providers, Healthcare, Medicare, Medicare Access and CHIP Reauthorization (MACRA)

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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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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, FDCA, 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, Healthcare, Healthcare Fraud, HHS, Kickbacks

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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, CMS, Health Care Providers, Healthcare

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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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TCPA: New Ruling May Invalidate Your Existing Consumer Consents

Much has been written about the Federal Communication Commission's ("FCC's") recent 138-page Declaratory Ruling and Order that broadened the scope of the Telephone Consumer Protection Act ("TCPA") and will likely encourage even…more

Advertising, ATDS, Compliance, Corporate Counsel, FCC

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Multiemployer Pension Plans

In this Update Series, we provide continuing updates on the key developments relating to multiemployer pension plans, as well as practical considerations for the companies that participate in them. These union benefit funds pose…more

ERISA, IRS, MPRA, Multiemployer Plan, PBGC

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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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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, SEC

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FDA Isn't Moving to Regulate Devices that Track Fitness Regimes!

At long last, the Food and Drug Administration issued its Nonbinding Recommendations and Guidance regarding "General Wellness: Policy for Low Risk Devices," announcing it will not regulate "low-risk general wellness products."…more

FDA, Fitbit, Fitness, Medical Devices, Mobile Apps

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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, 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, HIPAA, HIPAA Audits

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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

CMS, Healthcare, Healthcare Reform, Hospice, Hospitals

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NLRB: Peer Review Obligations Trumped by NLRA

On August 27, 2015, the National Labor Relations Board (“NLRB”) held that a Kansas hospital must afford an employee Weingarten rights before a nursing Peer Review Committee, allow the union access to peer review documents and…more

Confidentiality Policies, Decision-Making Process, Healthcare, Hospitals, KS Supreme Court

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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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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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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, EPA, Jurisdiction, Public Comment, Rulemaking Process

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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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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 Reform + Related Health Policy News - November 2013 - Issue 1

In This Issue: - Top News ..HHS Gives Mixed Messages Regarding Federal Health Care Program-Status of Qualified Health Care Plans (QHPs) ..HHS Issues Health Insurance Marketplace Enrollment Report Snapshot …more

Health Insurance Exchanges, Healthcare, HHS, Open Enrollment, Qualified Health Plans

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Chairman Hensarling Open to Revised Financial CHOICE Act

On November 15th, House Financial Services Committee Chairman Jeb Hensarling (R-TX) signaled that he is willing to consider changes to a reintroduced Financial CHOICE Act next year as a newly elected and party-unified government…more

Banks, CFPB, Dodd-Frank, Financial Sector, Proposed Legislation

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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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DOJ Issues New Cyber-Incident Preparedness and Response Guidance

The Department of Justice (DOJ) released new guidance on cyber preparedness and incident response last week, becoming the latest federal agency to do so in recent months. Newly sworn-in Attorney General, Loretta Lynch, has…more

Attorney Generals, Cyber Crimes, Cybersecurity Framework, Data Protection, DOJ

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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

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, SEC

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Grace Period Ends Soon for California Companies with Products Containing BPA

On May 11, 2016 products that contain Bisphenol A (BPA) manufactured, sold or distributed in California, without a proper warning, will be fair game for a Notice of Intent to Sue issued under the state’s Safe Drinking Water and…more

BPA, Corporate Counsel, Drinking Water, Manufacturers, OEHHA

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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, CMS, Contract Terms

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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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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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High Court Spokeo Ruling on Standing Avoids Nixing No Injury Class Actions

On May 16, 2016, the United States Supreme Court released its long-awaited opinion in Spokeo, Inc. v. Robins. In a 6–2 decision, the Court remanded the case to the Ninth Circuit for further analysis of the plaintiff's…more

Article III, Class Action, FCRA, Injury-in-Fact, SCOTUS

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Pharmacy Benefit Managers Face New Licensing Requirements

Two states recently enacted new pharmacy benefit manager licensing requirements that affect pharmacy benefit managers in Kentucky and New Mexico. It is important for Pharmacy Benefit Managers to ensure they are in compliance…more

Healthcare, Licenses, Pharmacies

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Five Things to Know About CMS's Second Round of Settlements for Hospital Appeals

The Centers for Medicare and Medicaid Services (CMS) announced that beginning December 1, 2016, it is offering to settle certain inpatient-status claims to eligible hospitals willing to withdraw from the administrative appeals…more

Appeals, CMS, Healthcare, Hospitals, Inpatient Billing

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Obama Signs Omnibus Budget Bill that Includes $622 Million in Tax Extenders

On December 18, 2015, President Obama signed the Protecting Americans from Tax Hikes Act of 2015 (the “PATH Act”) after both houses of Congress voted to approve the budget measure and comprehensive spending bill. The PATH Act…more

Cadillac Tax, IRS, Protecting Americans from Tax Hikes (PATH) Act, Renewable Energy, Tax Credits

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Agencies Encourage New Privacy Regulations to Close the mHealth Black Hole and Keep Pace with Evolving Technologies

On July 19, 2016, the ONC submitted a report to Congress which suggests that health privacy regulations soon may be revised to catch up with the universe of mHealth technologies that now use and share personal health data. The…more

Data Collection, Data Protection, Digital Health, Electronic Medical Records, Health Care Providers

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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, 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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H-1B Worksite Changes: Can Employers Expect Relief Before August 19th Deadline?

As H-1B employers scramble to create a plan of action to ensure compliance with new guidelines and interpretations surrounding H-1B workers and changes in worksite, industry leaders are calling for more temperate policy changes…more

Compliance, Employee Relocations, Filing Requirements, Foreign Workers, H-1B

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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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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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"Take-Home" Asbestos Case Decision Could have Ripple Effect

Companies facing "take-home" asbestos or other toxic tort exposure claims in Arizona, or in other jurisdictions applying Arizona law, now have a new case to cite in dispositive motions. With the Sept. 20 Arizona Court of Appeals…more

Appeals, Asbestos, Asbestos Litigation, Duty of Care, Hazardous Substances

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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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More Relief For Business: U.S. Supreme Court Continues To Restrict Far-Reaching Claims

In This Issue: - Comcast Corp v. Behrand - Take-Away from Comcast Corp v. Behrand - Standard Fire Insurance Co. v. Knowles - Take-Away from Standard Fire Insurance Co. v. Knowles Amgen Inc. v. -…more

American Express v Italian Colors Restaurant, Amgen Inc. v Connecticut Retirement Plans, Comcast v. Behrend, Oxford Health v Sutter, SCOTUS

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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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SEC Takes Aim at Anti-Whistleblower Employment Agreements

On Aug. 15, the U.S. Securities and Exchange Commission issued its second fine in six days to an employer for drafting severance agreements that restricted former employees from collecting awards as whistleblowers. The fines –…more

BlueLinx Holdings, Confidentiality Agreements, Dodd-Frank, Enforcement Actions, Health Net

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Olympus to Pay $632.2 Million to Resolve Allegations of Kickbacks

Olympus Corporation of the Americas, the United States’ largest distributor of endoscopes and related medical equipment, recently agreed to pay $623.2 million to resolve criminal charges and civil claims, according to a United…more

Criminal Prosecution, DOJ, False Claims Act (FCA), Government Investigations, Health Care Providers

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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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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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Uber-Complicated: Insurance Challenges for Transportation Network Companies

Transportation Network Companies (TNCs) facilitate the use of personal vehicles to transport passengers for a fee using a technology based platform, such as a website or a mobile application to connect riders and drivers. The…more

Auto Insurance, Insurance Industry, Lyft, Sidecar, Transportation Network Companies

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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, CMS, Health Care Providers, Healthcare

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