A timeline of Merck’s legal battle over Medicare negotiation

[Photocreo Bednarek/Adobe Stock]

Marking the first legal challenge of its kind, pharma giant Merck & Co. took to the courts on Tuesday, directly contesting the U.S. government over the Medicare drug price negotiation program. The Big Pharma company’s lawsuit, filed in the U.S. District Court for the District of Columbia, contends the program’s basis — the Inflation Reduction Act (IRA) — infringes upon the Fifth and First Amendments of the U.S. Constitution.

The legislation has put pricing pressure on the industry and contributed to a wave of recent M&A deals.

Merck, and the wider pharmaceutical industry, are raising the alarm. They claim the law, in effect, coerces drugmakers into accepting below-market rates. The lobbying group PhRMA (Merck is a member) released a statement in April 2023 arguing that the Inflation Reduction Act threatens patient access and complicates R&D efforts.…

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DOJ files fraud suit against Fresenius Medical division

Federal attorneys accused Fresenius Medical Care’s vascular care unit of performing unnecessary procedures on dialysis patients and billing the federal government.

U.S. Attorney for the Eastern District of New York Breon Peace made the allegations yesterday against Fresenius Vascular Care — doing business as Azura Vascular Care — as part of a whistleblower suit filed by two doctors in 2014.

Bad Homburg, Germany-based parent company Fresenius Medical Care said it disputes the allegations and intends to mount a vigorous defense.

“Our network of vascular centers is leading efforts to reduce total healthcare costs and improve patient outcomes by expanding access to innovative and less-invasive procedures,” the company said in a statement sent to Medical Design & Outsourcing. “Our policies are intended to result in a high standard of care and compliance with government regulations.”

Prosecutors said Azura Vascular Care…

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Medicare evaluating Aduhelm coverage while Democrats ask Biogen for documents 
While CMS is mulling potential coverage of the Alzheimer’s drug, Democrats are seeking information on the approv

As Medicare officials review evidence about Biogen’s (NSDQ:BIIB) Aduhelm (aducanumab) to determine if and how it will cover the drug, two high-level House Democrats are asking Biogen about its dealings with FDA. 

Yesterday, Carolyn Maloney (D-N.Y.) and Frank Pallone, Jr. (D-N.J.) sent a letter to Biogen CEO Michel Vounatsos asking for details about the company’s communications with FDA staff before it filed a Biologics License Application for aducanumab. Maloney chairs the House Committee on Oversight and Reform, while Pallone chairs the House Committee on Energy and Commerce.

The House isn’t alone in its push for such information regarding the drug, which could cost patients $56,000 annually in out-of-pocket expense. Acting FDA Commissioner Dr. Janet Woodcock recently asked the Office of Inspector General to launch an independent review of the agency’s dealings with Biogen during the Aduhelm approval process. 

Public Citizen recently filed a letter to C…

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Senate Finance committee senators call for hearing on Medicare coverage of aducanumab

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Senate finance committee members Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) are pushing to have a hearing to discuss the Medicare coverage of Aduhelm (aducanumab), Biogen’s controversial Alzheimer’s treatment, which recently won FDA approval.

In a letter addressed to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), Warren and Cassidy express concern that the drug could cost Medicare $37 billion to $90 billion annually. “This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resiliency,” they wrote.

The letter also recommends that Medicare consider limiting the use of the drug to patients most likely to benefit from it. The clinical trials for aducanumab focused on Alzheimer’s patients with mild cognitive impairment.

Biogen has yet to provide rig…

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Senate confirms new CMS leader

The U.S. Senate today confirmed President Joe Biden’s selection to lead CMS, Chiquita Brooks-Lasure, with a 55-44 vote in favor.

Brooks-Lasure will be the first Black woman to hold the position, according to Senate Majority Leader Chuck Schumer (D-N.Y.) on Twitter. She previously served in the U.S. Dept. of Health and Human Services during the Obama administration, during which time she helped to implement the Affordable Care Act, which she will now oversee as the Biden administration seeks to expand it.

Get the full story at our sister site, MassDevice.

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Medicare drug pricing cuts face long odds, expert says

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One of the chief objectives of various drug pricing reform efforts in recent years has been reducing Medicare costs for patients and the federal government.  

Last year, CMS highlighted reductions in prices for insulin and other drugs covered under the Medicare prescription drug benefit (Medicare Part D). But it is more likely that Medicare drug prices for consumers will increase in coming years, according to Ron Elledge, a Medicare consultant at MedicarePlans.com.

“If the new administration returns to some form of Obamacare as predicted, and the Medicare age decreases to 60 years as President Biden desires, the premiums for Medicare Part D will most likely escalate and the cost of drugs for all will see an unpredictable increase,” he said. “History demonstrates that when the government takes a greater hand in the regulation…

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Unclear path for drug-pricing reform after Dem sweep 

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With Democrats having gained control of the Senate and the presidency, some form of drug-pricing reform is likely. But with the raging COVID-19 pandemic and ongoing threats to the Affordable Care Act, Democrats are more likely to focus on those issues in the near term, according to Barrett Thornhill, a partner at the public affairs firm Forbes Tate in a call with UBS analysts.

The political dynamics of the House is one challenge. Even though Democrats have narrow control of the House, they also have an increasingly vocal progressive wing. For that reason, bipartisan healthcare policy from the Senate could “actually have some trouble when it goes to the House because it’s not left enough,” Thornhill said.

COVID-19 itself has stymied prior legislative attempts at drug-pricing reform, while President Trump’s executive orders face ongoing legal challenges.


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