Donations to Patient Assistance Charities
On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more
Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more
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
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
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
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
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
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
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
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
Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more
On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and...more
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
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 Governor of Oregon signed into law this week House Bill 4005, the Prescription Drug Price Transparency Act (Act). The Act requires manufacturers to report by March 31st each year information regarding each prescription...more
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
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
As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in...more
Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more
On December 28, 2015, the Office of Inspector General (OIG) approved another patient assistance program in Advisory Opinion 15-16. The OIG analyzed contributions to a private charitable organization under the anti-kickback...more
On December 28, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued OIG Advisory Opinion 15-17, approving a charity’s proposal to unveil a new patient assistance program dedicated to...more
On December 7, 2015, OIG posted a modification adding additional strictures to a prior favorable Advisory Opinion (No. 07-11) regarding a charity’s operation of a patient assistance program (PAP) to provide financial...more
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
Introduction - The OIG has released a Supplemental Special Advisory Bulletin that “reiterates and amplifies” previous OIG Special Advisory Bulletin guidance from 2005. Pharmaceutical manufacturers and Patient...more
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