News & Analysis as of

Department of Health and Human Services (HHS) Prescription Drugs Patient Assistance Programs

Arnall Golden Gregory LLP

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

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

K&L Gates LLP

Increased Scrutiny of Patient Assistance Programs: Enforcement Overview and Considerations

K&L Gates LLP on

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

Holland & Knight LLP

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

Holland & Knight LLP on

On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more

Epstein Becker & Green

OIG Supplemental Advisory Bulletin on Patient Assistance Programs Leaves Open Questions for High-Cost Breakthrough Drugs in...

Epstein Becker & Green on

On May 21, 2014, the Office of the Inspector General ("OIG") of the Department of Health and Human Services issued a Supplemental Special Advisory Bulletin ("Supplemental Bulletin") addressing the risks that Independent...more

Skadden, Arps, Slate, Meagher & Flom LLP

"HHS OIG Issues New Guidance on Patient Assistance Programs"

On May 21, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a special advisory bulletin addressing independent charity patient assistance programs (PAPs) for federal health care...more

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