News & Analysis as of September 19, 2024

Safe Harbors

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on 11/3/2023

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

OIG Looks at How Employed Physicians Bonuses Are Paid from ASC Profits

Holland & Knight LLP on 10/23/2023

The U.S. Department of Health & Human Services Office of the Inspector General (OIG) on Oct. 13, 2023, posted Advisory Opinion No. 23-07 detailing a favorable response to a proposal by a Requestor to pay bonuses to its...more

New Stark Law Exception and Anti-Kickback Statute Safe Harbor Aim to Combat Physician Burnout

Stevens & Lee on 7/26/2023

Health care professionals have faced increasing burnout and mental health issues in the wake of the COVID-19 pandemic. In an effort to address these rising issues, Congress passed the Dr. Lorna Breen Health Care Provider...more

OIG Declines To Challenge Debt Cancellation and Restructured Financial Arrangements Between Health System and FQHC “Look-Alike”...

ArentFox Schiff on 9/30/2022

In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more

Investing In or Opening an Ambulatory Surgery Center? Beware of State & Federal Regulations

Hendershot Cowart P.C. on 8/11/2022

Investment in ambulatory surgery centers (ASCs) is soaring. Physicians, hospitals, and health systems are attracted by the high margins, significant growth potential, payer influence, and efficient patient care. Beyond...more

“Stark” Rules: Navigating Physician Leases and Subleases

Tucker Arensberg, P.C. on 1/13/2022

Under the Federal Ethics in Patient Referrals Act (more commonly known as “Stark”), if a physician has a financial relationship with an entity, the physician may not refer patients to the entity for medical services payable...more

OIG Issues New Advisory Opinion Regarding Investment in Ambulatory Surgery Centers

King & Spalding on 5/12/2021

Last week, OIG considered a proposed investment by a health system, a management company, and certain surgeons in an ambulatory surgery center (ASC). OIG advised that the proposed arrangement would generate prohibited...more

Searching for Safe Harbors? CMS-Sponsored Model Participants Receive Anti-Kickback Statute Protection

ArentFox Schiff on 1/15/2021

Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor. ...In its mission to reward value over volume, the Centers for Medicare & Medicaid Services’ (CMS)...more

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

Sheppard Mullin Richter & Hampton LLP on 12/3/2020

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing

Mintz - Health Care Viewpoints on 6/26/2020

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two...more

Regulatory Sprint to Coordinated Care: CMS/AKS and OIG Stark Proposed Amendments

Tucker Arensberg, P.C. on 10/23/2019

HHS has long admitted that the Anti-Kickback Statute (AKS) and the Stark law have not evolved to keep pace with the transition to value based care. In June of 2018, HHS issued an RFI seeking additional information and HHS...more

CMS and OIG Release Long-Awaited Stark Law and Anti-Kickback Statute Proposed Rules

Ballard Spahr LLP on 10/18/2019

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) recently released two proposed rules restructuring the Physician Self-Referral...more

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

Dorsey & Whitney LLP on 9/10/2019

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more

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

K&L Gates LLP on 9/6/2019

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

Investigations Newsletter: Doctors and Alabama Cardiac Center to Pay $1.1 Million to Resolve Kickback Allegations

ArentFox Schiff on 8/30/2019

Doctors and Alabama Cardiac Center to Pay $1.1 Million to Resolve Kickback Allegations - On August 27, the US Attorney’s Office for the Western District of Washington announced a $1.1 million settlement with three...more

Drug Pricing: White House Announces Withdrawal of Proposed Changes to Anti-Kickback Safe Harbors

Foley & Lardner LLP on 7/24/2019

On July 11, 2019, the Trump administration announced it would withdraw a proposed rule that would eliminate the Anti-Kickback Statute (AKS) safe harbor that protected rebates made from pharmaceutical manufacturers to pharmacy...more

Trump Administration Withdraws Proposed Rebate Rule

Mintz - Health Care Viewpoints on 7/12/2019

In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more

Life Sciences Due Diligence: A Reference Guide for Your Life Sciences Corporate Transactions

Akin Gump Strauss Hauer & Feld LLP on 5/2/2019

• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny. • Conducting effective legal and regulatory due diligence can mean uncovering risks...more

Certain Pharmaceutical Discounts No Longer Safe Under the "Safe Harbors"?

Jones Day on 3/6/2019

The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products. On February 6, 2019, the Department of Health and Human Services ("HHS") published...more

OIG Proposes Revisions to Anti-Kickback Safe Harbor Regulations Affecting Prescription Drug Rebates

Verrill on 2/20/2019

Recently, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) in the Federal Register to amend the federal anti-kickback statute safe harbor...more

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

Sheppard Mullin Richter & Hampton LLP on 2/12/2019

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

HHS Issues Proposed Rule to Remove Safe Harbor for Drug Rebates

K&L Gates LLP on 2/12/2019

On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if finalized, would modify the discount safe harbor under the federal Anti-Kickback...more

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

Hogan Lovells on 2/11/2019

In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Drug Pricing and Payment Policy: Sweeping HHS Rebate Reform Proposal and First 2019 Congressional Hearings

Latham & Watkins LLP on 2/6/2019

HHS proposes to remove rebates from the Anti-Kickback Statute’s “discount” safe harbor and add new safe harbor for point-of-sale discounts. On January 31, 2019, the Department of Health and Human Services (HHS) announced a...more

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

Epstein Becker & Green on 2/6/2019

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

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