News & Analysis as of

Medicare Co-payments

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

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

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2022 #2

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Drug Pricing Initiatives: Discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA). ...more

Chambliss, Bahner & Stophel, P.C.

Medicare Premiums to Increase Dramatically in 2022

Medicare premiums are rising sharply next year, cutting into the large Social Security cost-of-living increase. The basic monthly premium will jump 15.5 percent, or $21.60, from $148.50 to $170.10 a month. The Centers for...more

Goodwin

Alere Pays $198.75 Million to Settle False Claims for Allegedly Billing Medicare for Defective POC Devices, Not Charging Copays,...

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Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...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

Rivkin Radler LLP

Teva under Fire from DOJ

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Teva Pharmaceuticals USA Inc. is in the crosshairs of the U.S. Department of Justice (DOJ) on two separate matters. On August 18, the DOJ announced that it filed a lawsuit against Teva and an affiliate, Teva Neuroscience...more

Robins Kaplan LLP

Financial Daily Dose 8.19.2020 | Top Story: S&P 500 Erases Pandemic Losses Despite U.S. Failure to Control Virus

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Unlike much of the world, the U.S. has not turned the corner on the coronavirus outbreak. But you wouldn’t know it by looking at the markets. On Tuesday, the S&P 500 topped out at its highest level ever, “capping a remarkable...more

The Volkov Law Group

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

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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

Foley & Lardner LLP

Medicare Remote Patient Monitoring: CMS Finalizes New Code and General Supervision

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CMS just released the 2020 final rule with changes to remote patient monitoring (RPM), officially titled “Chronic Care Remote Physiologic Monitoring,” reimbursed under the Medicare program, as part of the Physician Fee...more

Foley Hoag LLP - White Collar Law &...

No Good Deed Goes Unpunished: DJ's Pursuit of Alleged Drug Co-Pay Kickbacks Extends to the Charities Themselves

Back in May, we wrote about substantial settlements totaling $125 million to resolve Department of Justice (DOJ) allegations that money donated by Astellas Pharma US, Inc. and Amgen Inc. to drug co-pay charities constituted...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

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

Saul Ewing Arnstein & Lehr LLP

Kmart Settlement Shows Breadth of Healthcare Practices Government Says Violate False Claims Act

A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more

BakerHostetler

OIG Advisory Opinion 15-07: An Indicator of Clinical Trial Copayment Change?

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“You scratch my back, I scratch yours” arrangements are common in business transactions. These agreements are risky in the healthcare space, however, with the potential to implicate civil and criminal sanctions. Whether...more

Poyner Spruill LLP

Placing Medicare Beneficiaries Into "Observation Status" - Recent Second Circuit Decision Casts Doubt on Lawfulness of CMS...

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The trend toward placing more Medicare beneficiaries into observation status in the hospital has come under increasing attack by patient advocates. Such patients are considered outpatients reimbursed by Medicare Part B rather...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

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

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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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