News & Analysis as of

Co-payments Anti-Kickback Statute

Goodwin

“Greenfield Fraught with Problems”: District of Massachusetts Holds But-For Causation Required in False Claims Act Cases Based on...

Goodwin on

On September 27, 2023, the Chief Judge of the District of Massachusetts decided that the standard in False Claims Act (“FCA”) cases premised on alleged violations of the Anti-Kickback Statute (“AKS”) is but-for causation....more

Akerman LLP - Health Law Rx

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

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

Warner Norcross + Judd

Second Circuit Rules Anti-Kickback Statute Means No “Corrupt Intent” Required for Liability

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On January 9, 2023, the U.S. Supreme Court denied Pfizer Inc.’s petition for a writ of certiorari. The denial brought the pharmaceutical company’s lawsuit challenging the breadth of the federal Anti-Kickback Statute (AKS) to...more

Akin Gump Strauss Hauer & Feld LLP

Updates in Co-Pay Assistance and Accumulators Litigation

Key Points - A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more

Akin Gump Strauss Hauer & Feld LLP

Updates in Co-Pay Assistance and Accumulators Legal Developments

Key Points - Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs. The Second Circuit has upheld HHS’ prohibition of co-pay...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

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January - April 2022 Recap

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This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

Goodwin

Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance

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In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...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

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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

Rivkin Radler LLP

Gilead Reaches $97 Million FCA/AKS Settlement

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On September 23, the U.S. Department of Justice announced that pharmaceutical company Gilead Sciences, Inc. agreed to pay $97 million to resolve claims that it illegally used a foundation as a conduit to pay the copays of...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

The Volkov Law Group

Two Charitable Foundations Pay $6 Million for Anti-Kickback Violations

The Volkov Law Group on

Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million.  The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more

Robinson+Cole Health Law Diagnosis

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

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

The Volkov Law Group

Three Pharmaceutical Companies Pay a Total of $122 Million to Settle Kickback Allegations Involving Co-Pay Assistance Foundations

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In a significant False Claims Act enforcement action, DOJ announced settlements with three pharmaceutical companies – Jazz Pharmaceuticals, Lundbeck, and Alexion Pharmaceuticals – under which they agreed to pay $122 million...more

Hogan Lovells

Massachusetts anti-opioid law bans manufacturer copay assistance

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On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect immediately. ...more

Mintz - Health Care Viewpoints

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...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

Robinson & Cole LLP

Health Law Pulse - January 2015

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In This Issue: - Connecticut Supreme Court Rules State Does Not Recognize Mature Minor Doctrine - OIG Issues Advisory Opinion Permitting Copayment Assistance - CMS Announces Recovery Audit Program...more

Mintz - Health Care Viewpoints

OIG Provides Leeway for Copay Assistance to Low-Income Patients

Earlier this week the OIG released an advisory opinion stating that a nonprofit organization’s proposed arrangement to provide copayment assistance to financially needy patients would not result in civil monetary penalties or...more

Saul Ewing Arnstein & Lehr LLP

Pharmaceutical manufacturers beware: HHS OIG issues warning about copay coupon programs

The Office of Inspector General of the Department of Health and Human Services recently issued a warning to pharmaceutical manufacturers, reminding them that copay coupons used for drugs purchased through federal healthcare...more

Faegre Drinker Biddle & Reath LLP

OIG Warns Pharma Its Copayment Coupons May Aid Crime

Brand name drugs cost a lot. So to make them more attractive, drug manufacturers issue coupons for discounts on the copayment portion of the price. They work the same as the dollar-off coupons offered by cereal manufacturers....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

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