News & Analysis as of August 18, 2025

Pharmaceutical Industry

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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 -

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

Gardner Law on 5/29/2025

Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

Foley Hoag LLP - White Collar Law &... on 5/2/2025

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

ArentFox Schiff on 4/16/2025

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

OIG Issues a Favorable Advisory Opinion to a Pharmaceutical Manufacturer Regarding Free Transportation, Lodging and Support for...

King & Spalding on 1/21/2025

On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more

OIG’s Perspective on Discount and Refund Programs

Gardner Law on 10/23/2024

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

OIG Issues Favorable Advisory Opinion Regarding Proposed Patient Assistance Program Operated by a Nonprofit Grant-Making...

King & Spalding on 9/5/2024

On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

Bass, Berry & Sims PLC on 6/28/2024

On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

Foley Hoag LLP on 5/13/2024

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers

Foley & Lardner LLP on 4/26/2024

The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

Sheppard Mullin Richter & Hampton LLP on 2/28/2024

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more

Court Upholds OIG Advisory Opinion Shooting Down a Patient Assistance Program

Holland & Knight LLP on 2/5/2024

Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

McDermott Will & Schulte on 11/30/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

McDermott Will & Schulte on 9/1/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

OIG Issues Favorable Opinion Regarding Pharmaceutical Company’s Free 14-Day Drug Supply to Patients Experiencing a Delay in...

King & Spalding on 3/10/2023

On February 28, 2023, OIG posted Advisory Opinion 23-02, responding to a request by a pharmaceutical company (the Company) regarding its proposal to offer a free 14-day supply of an enzyme replacement therapy drug to patients...more

OIG Advisory Opinion Highlights Further Concerns for Patient Assistance Programs

Holland & Knight LLP on 11/3/2022

Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more

OIG Issues Advisory Opinion Regarding Pharmaceutical Companies’ Proposed Arrangement to Provide Cost-Sharing Subsidies

King & Spalding on 10/17/2022

On October 5, 2022, OIG posted Advisory Opinion 22-19 in response to a nonprofit corporation’s (Requestor) request to analyze a proposal for certain pharmaceutical companies (each, the Funding Manufacturer) to subsidize: 1)...more

OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies

Sheppard Mullin Richter & Hampton LLP on 10/13/2022

On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

McDermott Will & Schulte on 10/7/2022

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

McDermott Will & Schulte on 8/8/2022

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” Element

Bass, Berry & Sims PLC on 7/29/2022

On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services...more

OIG Modifies 2020 Advisory Opinion Regarding Financial Assistance for Travel, Lodging, and Other Expenses for Certain Patients by...

King & Spalding on 6/8/2022

On May 26, 2022, OIG issued a modification of Advisory Opinion 20-02 (2020 Opinion), which was originally issued on January 15, 2020. In the 2020 Opinion, OIG issued a favorable advisory opinion regarding a pharmaceutical...more

Healthcare Regulatory Check-Up Newsletter | January - April 2022 Recap

McDermott Will & Schulte on 5/27/2022

This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

OIG Issues Favorable Advisory Opinion for Free Genetic Testing and Counseling Program Offered by a Pharmaceutical Company

Faegre Drinker Biddle & Reath LLP on 5/3/2022

On April 11, 2022, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion No. 22-06 (AO 22-06), which approved a biopharmaceutical company’s proposed arrangement to...more

OIG Issues Favorable Advisory Opinion Regarding Biopharmaceutical Company Arrangement to Provide Free Genetic Testing and...

King & Spalding on 4/21/2022

Last week, OIG posted Advisory Opinion No. 22-06 regarding a biopharmaceutical company’s (BioPharm Co.) arrangement to provide free genetic testing and genetic counseling services to patients potentially eligible for...more

OIG Approves Manufacturer’s Offer of Free Genetic Testing

Mintz - Health Care Viewpoints on 4/15/2022

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...more

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Anti-Kickback Statute › Advisory Opinions › Pharmaceutical Industry

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