News & Analysis as of

Patient Assistance Programs Pharmaceutical Industry Office of the Inspector General

King & Spalding

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

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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

Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

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

Holland & Knight LLP

Court Upholds OIG Advisory Opinion Shooting Down a Patient Assistance Program

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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

Holland & Knight LLP

OIG Advisory Opinion Highlights Further Concerns for Patient Assistance Programs

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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

Baker Donelson

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

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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

Epstein Becker & Green

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

Epstein Becker & Green on

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

Foley & Lardner LLP

OIG Greenlights Digital Health Program Offering Free Smartphones to Patients

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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

Troutman Pepper

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

Troutman Pepper on

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

Mintz - Health Care Viewpoints

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

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

King & Spalding

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

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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

Hogan Lovells

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

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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

Holland & Knight LLP

OIG Approves Pharmaceutical Manufacturer’s Loaning of Smartphones to Support Digital Medicine (DM)

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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

Akin Gump Strauss Hauer & Feld LLP

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

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

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

K&L Gates LLP

Increased Scrutiny of Patient Assistance Programs: Enforcement Overview and Considerations

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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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Holland & Knight LLP

OIG Rescinds Advisory Opinion

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The Department of Health and Human Services Office of Inspector General (the OIG), on November 28, 2017, issued a Rescission Letter terminating Advisory Opinion Number 06-04 (Advisory Opinion 06-04). In Advisory Opinion...more

Cooley LLP

Blog: Enforcement Trend: Patient Assistance Programs

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Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance...more

Baker Donelson

OIG Supplemental Special Advisory Bulletin Raises New Concerns About Independent Charity Patient Assistance Programs

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In an effort to address new concerns about the independence of charity patient assistance programs (PAPs), the Office of Inspector General (OIG) released its Supplemental Special Advisory Bulletin: Independent Charity Patient...more

Epstein Becker & Green

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

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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

Cooley LLP

HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

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On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs...more

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