News & Analysis as of November 17, 2024

Anti-Kickback Statute › Patient Assistance Programs

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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 -

Third-Party Co-Pay Assistance Program Kickback Scheme Results in $450 Million DOJ Settlement

Benesch on 10/16/2024

Teva Pharmaceuticals, the largest generic drug manufacturer in the United States, has agreed to pay $450 million to resolve allegations of violating the False Claims Act and Anti-Kickback Statute arising from purported...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 Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

Arnall Golden Gregory LLP on 8/1/2024

On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA...

Proskauer - Health Care Law Brief on 5/29/2024

In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

Arnall Golden Gregory LLP on 5/2/2024

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...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

Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

Akerman LLP - Health Law Rx on 8/10/2023

How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...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 Closes the Door on Coalition-Model Patient Assistance Programs in its Latest Advisory Opinion

Bass, Berry & Sims PLC on 10/12/2022

On October 5, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion No. 22-19, finding that a proposal by an entity funded entirely by manufacturers of oncology...more

OIG Issues Favorable Advisory Opinion For Federally Qualified Health Center’s Smartphone Loan Program

Sheppard Mullin Richter & Hampton LLP on 8/12/2022

The Office of the Inspector General (“OIG”) recently issued Advisory Opinion 22-08 (the “Advisory Opinion”), concluding that the provision of limited use smartphones by a federally qualified health center (“FQHC”) to...more

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

Baker Donelson on 2/29/2020

In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

OIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients’ Travel, Lodging, and Other Expenses

Epstein Becker & Green on 1/30/2020

On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides...more

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

Robinson+Cole Health Law Diagnosis on 9/18/2019

On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more

DOJ Announces Settlements with Three Pharma Companies Related to Allegations of Co-Pay Assistance Kickbacks Through Conduit...

Arnall Golden Gregory LLP on 4/24/2019

On April 4, 2019, the Department of Justice (DOJ) announced settlements with three pharmaceutical companies, Jazz Pharmaceuticals plc (Jazz), Lundbeck LLC (Lundbeck), and Alexion Pharmaceuticals (Alexion), related to...more

OIG Advisory Opinion No. 19-03: The OIG Puts the Healthcare Benefits of Free In-Home Care and the Risks of Patient Steering in the...

Sheppard Mullin Richter & Hampton LLP on 3/11/2019

On March 6, 2019, the Department of Health & Human Services, Office of the Inspector General (“OIG”) published a new advisory opinion, No. 19-03 (the “AO”), addressing a proposed arrangement to provide free post-discharge...more

OIG Advisory Opinion Has Key Takeaways for Programs Designed to Assist Needy Patients

Troutman Pepper on 2/11/2019

Can a pharmaceutical manufacturer provide free items or services to financially needy Medicare and Medicaid beneficiaries without running afoul of the Beneficiary Inducements Civil Monetary Penalty (CMP) or the Anti-Kickback...more

OIG Advisory Opinion Allows Smartphone Loan for Needy Patients Taking Digital Drug

Mintz - Health Care Viewpoints on 2/7/2019

Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more

OIG Issues Advisory Opinion Giving the Green Light to a Pharmaceutical Manufacturer’s Plan to Provide Limited Functionality...

King & Spalding on 2/5/2019

On January 24, 2019, OIG issued Advisory Opinion No. 19-02, analyzing a proposed arrangement in which a pharmaceutical manufacturer would loan smartphones to patients who meet certain poverty level requirements in order to...more

HHS OIG: Smartphone loaner to needy patients may not violate Anti-Kickback Statute

Hogan Lovells on 2/4/2019

On Tuesday, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 19-02, advising that OIG would not pursue enforcement under the Anti-Kickback Statute (AKS) or the...more

OIG Approves Manufacturer Loaning Smartphones as Appropriate Patient Assistance to Support Digital Medicine

Akin Gump Strauss Hauer & Feld LLP on 1/30/2019

On January 29, the Health and Human Service Office of Inspector General (OIG) released new guidance that sheds further light on the types of patient assistance that may be provided under the “Promotes Access to Care”...more

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Increased Scrutiny of Patient Assistance Programs: Enforcement Overview and Considerations

K&L Gates LLP on 3/22/2018

In the midst of ongoing national debates regarding drug pricing [1] and access to innovative therapies, patient assistance programs (“PAPs”) are facing an evolving legal landscape, as well as increased enforcement scrutiny...more

The Giving Season Is Over: Practical Advice for Patient Assistance Programs in the Wake of United Therapeutics’ $210 Million False...

Bradley Arant Boult Cummings LLP on 1/24/2018

Right before Christmas last year, the Department of Justice (DOJ) announced an ominous settlement: United Therapeutics, a manufacturer of pulmonary arterial hypertension drugs, agreed to pay more than $200 million to settle...more

Blog: OIG Permits Drug Companies To Provide Free Medications in Limited Circumstances to Patients for 2018 Following Advisory...

Cooley LLP on 1/17/2018

As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that...more

Blog: OIG Revokes Patient Assistance Program Advisory Opinion Protection

Cooley LLP on 12/12/2017

The Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04) on November 28, 2017, retroactive to its original issuance date of April 20, 2006. Opinion 06-04 had been modified by the OIG on December...more

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Anti-Kickback Statute › Patient Assistance Programs

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