News & Analysis as of

Safe Harbors Department of Health and Human Services (HHS) Hospitals

ArentFox Schiff

Physician Wellness Programs: A New Stark Law Exception and AKS Safe Harbor to Combat Burnout

ArentFox Schiff on

The recently passed Consolidated Appropriations Act (CAA) of 2023 includes a new Stark Law exception and Anti-Kickback Statute (AKS) safe harbor, allowing hospitals and other health care entities to offer their physicians...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...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

BakerHostetler

Stark and AKS Rules Cross the Finish Line of HHS Regulatory Sprint

BakerHostetler on

With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback...more

Seyfarth Shaw LLP

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

Seyfarth Shaw LLP on

On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...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

McGuireWoods Consulting

Washington Healthcare Update - December 2019 #1

McGuireWoods Consulting on

This Week in Washington: The House and Senate are back from Thanksgiving recess. Congress is expected to be in session until or about Dec. 20....more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

Epstein Becker & Green on

This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...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

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 1: Value-Based Arrangements

As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that,...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

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

McDermott Will & Emery

HHS Proposes Substantial Changes to Stark Law and Anti-Kickback Statute Regulations

McDermott Will & Emery on

The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 1

K&L Gates LLP on

In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...more

Foley & Lardner LLP

Some Helpful Managed Care Guidance Provided in Advisory Opinion 18-11

Foley & Lardner LLP on

Practitioners in the Medicare or Medicaid managed care space place heavy reliance on the protection of the Anti-Kickback Statute (AKS) Safe Harbor found at 42 C.F.R. § 1001.952(t), generally known as the “EMCO [eligible...more

Sheppard Mullin Richter & Hampton LLP

How Broad is the Managed Care Safe Harbor?

In Advisory Opinion No. 18-11, the Department of Health and Human Services Office of the Inspector General (the “OIG”) addressed a Medicaid managed care organization’s (“MCO”) proposal to pay its contracted providers and...more

Mintz - Health Care Viewpoints

OIG Opinion Illustrates the Need for New AKS Safe Harbors

The Department of Health and Human Services Office of the Inspector General (OIG) has issued Advisory Opinion No. 18-10 (Opinion) in response to a proposal by a surgical device and wound care product manufacturer...more

Bass, Berry & Sims PLC

Sprinting to Coordinated Care: Healthcare Industry Urges Stark Law Relief as OIG Solicits Feedback on Changes to the Anti-Kickback...

August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more

Holland & Knight LLP

Healthcare Law Update: September 2018

Holland & Knight LLP on

Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Ruder Ware

New Safe Harbor Permits Some Free Transportation to Patients

Ruder Ware on

A new safe harbor was recently issued by the Health and Human Services (HHS) Office of Inspector General (OIG) that permits eligible health care providers to offer free or discounted transportation to established patients....more

Roetzel & Andress

Health Law Insights: January Newsletter

Roetzel & Andress on

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

King & Spalding

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

King & Spalding on

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more

Mintz - Health Care Viewpoints

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

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