News & Analysis as of

Medicare Part D Co-payments

Benesch

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

Benesch on

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

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more

Akin Gump Strauss Hauer & Feld LLP

Co-Pay Assistance and Accumulators in the Legal Spotlight: A Changing Landscape

Key Points - Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs. Co-pay programs remain unavailable to participants in federal...more

Pullman & Comley - Connecticut Health Law

Health Care Providers Should Take Note of Recent Repeals and Extensions of COVID-Related Executive Orders

Governor Lamont’s recent renewal of his declaration of the public health and civil preparedness emergencies through July 20, 2021 was followed by  Executive Order 12B that repeals portions of previously-issued Executive...more

Faegre Drinker Biddle & Reath LLP

HHS-OIG: Pharma Manufacturer’s Proposed Copayment Assistance Program ‘Highly Suspect’ Under Federal Anti-Kickback Statute

On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a...more

Hogan Lovells

OIG denies proposed manufacturer-sponsored copay support program for Medicare beneficiaries

Hogan Lovells on

On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to help certain financially eligible Medicare...more

Patrick Malone & Associates P.C. | DC Injury...

Why Industry Drug-Assistance Programs Are a Sham

You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more

Mintz - Health Care Viewpoints

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more

Baker Donelson

OIG Warns About Risk of Drug Coupons, But Offers No Solution

Baker Donelson on

On September 18, 2014, the OIG simultaneously issued a Report [PDF] and Special Advisory Bulletin [PDF] warning about the potential fraud and abuse risks posed by coupons offered by pharmaceutical manufacturers when those...more

BakerHostetler

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

BakerHostetler on

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more

Cooley LLP

OIG Releases Special Advisory Bulletin and Report on Copayment Coupons

Cooley LLP on

Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled,...more

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