News & Analysis as of

Safe Harbors Exceptions

Foley & Lardner LLP

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

Foley & Lardner LLP on

Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.  The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more

McDermott Will & Emery

[Event] Value-Based Care Symposium 2024 - May 16th - 17th, Nashville, TN

WHERE VALUE-BASED CARE MEETS THE BUSINESS OF HEALTHCARE - Join hundreds of c-suite leaders, investors, operators and counsel in the healthcare capital of the United States for a deep dive into the key business and policy...more

WilmerHale

FTC Publishes Proposed Amendments to COPPA Rule

WilmerHale on

On December 20, the Federal Trade Commission (FTC or “the Commission”) published a notice of proposed rulemaking (NPRM) proposing amendments to the Children’s Online Privacy Protection Rule (the “COPPA Rule” or the “Rule”)....more

Health Care Compliance Association (HCCA)

Defensibility of a fair market value analysis

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

Latham & Watkins LLP

Hong Kong Introduces Major Updates to Its Copyright Regime

Latham & Watkins LLP on

A recent amendment addresses key loopholes and aims to align Hong Kong’s copyright regime with international standards. On 16 December 2022, the Hong Kong Copyright (Amendment) Ordinance 2022 (Amendment) was finally...more

Epstein Becker & Green

Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program - Diagnosing Health Care

The Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General ("OIG") of the Department of Health and Human Services have at last published their long-awaited companion final rules advancing...more

Health Care Compliance Association (HCCA)

[Webinar] What Compliance Professionals Need to Know About the New Stark and Anti-Kickback Regulations - January 29th, 12:00 pm -...

Learning Objectives: - Explain changes to existing concepts including fair market value, commercial reasonableness, and volume or value - Examine the new definitions, exceptions, and safe harbors and their impact on...more

Verrill

The Regulatory Sprint is Over – What’s at the Finish Line Under the New Stark and AKS Final Rules?

Verrill on

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare &...more

McDermott Will & Emery

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more

Davis Wright Tremaine LLP

Done Sprinting, but Are We There Yet? The Value-Based Stark Exceptions and AKS Safe Harbors

On December 2, 2020, CMS and OIG finished a two-year sprint to modernize the Stark and Anti-Kickback (AKS) regulations to remove barriers to value-based care and incentivize patient-centered care coordination....more

Sheppard Mullin Richter & Hampton LLP

Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the...

On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify”...more

Fox Rothschild LLP

U.S. States And Territories Data Breach Statutes-UPDATED July, 2020

Fox Rothschild LLP on

Fox Rothschild’s Privacy and Data Security practice group maintains this searchable PDF document as well as the Data Breach 411 app to inform businesses of the breach notification statutes in each of the 50 states, Guam,...more

Manatt, Phelps & Phillips, LLP

Nasdaq Provides Temporary Relief From Shareholder Approval Requirements

On May 4, 2020, in response to the tremendous economic uncertainty and ensuing securities market downturn resulting from COVID-19, the Securities and Exchange Commission approved effective immediately Nasdaq Listing Rule...more

Sullivan & Worcester

Nasdaq Provides Temporary Relief from Shareholder Approval Rules #2

Sullivan & Worcester on

The Nasdaq Stock Market is temporarily providing an exception from shareholder approval requirements for certain common stock issuances, permitting companies to raise capital quickly to continue running their businesses. The...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides CITGO Asphalt Refining Co. v. Frescati Shipping Co., No. 18-565

On March 30, 2020, the U.S. Supreme Court decided CITGO Asphalt Refining Co. v. Frescati Shipping Co., No. 18-565, construing a safe-berth clause in a widely used charter contract as a warranty of safety, and not simply a due...more

Tucker Arensberg, P.C.

It Is Not Illegal to Pay Physicians More Than They Generate

While we are waiting for final disposition of the AKS Safe Harbors and Stark Exceptions proposed in October of 2019, since the comment period expired December 31, 2019 and final rules have not been issued, I thought we should...more

Manatt, Phelps & Phillips, LLP

[Webinar] Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms - February 13th, 1:00 pm ET

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for...more

Bradley Arant Boult Cummings LLP

Lawmakers Propose CCPA Amendment to Further Except Healthcare and Research Information - Cybersecurity and Privacy Alert

A little more than a week after California’s groundbreaking California Consumer Protection and Privacy Act (CCPA) went into effect on January 1, the Senate Health Committee unanimously approved A.B. 713, introduced by...more

Baker Donelson

Regulatory Sprint: HHS Proposes Expansion of Protections for EHR and Cybersecurity Donations

Baker Donelson on

In furtherance of its goals of expanding the adoption of electronic health records (EHR) and improving security through the use of cybersecurity technology, the Department of Health and Human Services (HHS) has proposed...more

Tucker Arensberg, P.C.

Regulatory Sprint to Coordinated Care: New Stark & Anti-Kickback Rules

Tucker Arensberg, P.C. on

On October 22, 2019, CMS and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory...more

Womble Bond Dickinson

Trump Administration’s ‘Regulatory Sprint’ Includes Revisions to Stark Law and Anti-Kickback Statute

Womble Bond Dickinson on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) released two proposed rules: Modernizing and Clarifying the Physician Self-Referral Regulations and Fraud and Abuse; Revisions to Safe Harbors under the...more

WilmerHale

Proposed Changes to Stark and Anti-Kickback Regulations May Provide New Flexibility for Healthcare Providers

WilmerHale on

On October 9, 2019, the Department of Health and Human Services (HHS) announced proposals for a number of new and revised exceptions to the Stark Law and safe harbors for the Anti-Kickback Statute (AKS) that are intended to...more

Faegre Drinker Biddle & Reath LLP

New Stark Law Exceptions for Value-Based Care

On October 9, 2019, the U.S. Department of Health and Human Services released proposed changes to the Ethics in Patient Referrals Act (the “Stark Law”), as well as the Medicare and Medicaid Anti-Kickback Statute (the...more

Faegre Drinker Biddle & Reath LLP

New Proposed Cybersecurity and EHR Donation Rules

On October 9, 2019, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) simultaneously released a set of proposed rules (the “Proposed Rules”) that, among other...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to Anti-Kickback Statute and Stark Law

On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued...more

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