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Home » Topics » Regulatory » CMS

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Medicare puzzle

MedPAC not ready to move on Medicare site-neutral payments

Feb. 5, 2025
By Mark McCarty
Site neutral payments under the U.S. Medicare program have been contentious for some time, and Congress seems poised to act on the issue in 2025. The Medicare Payment Advisory Commission is wary of making any recommendations as yet — a position that MedPAC may hold pending the collection of additional data.
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U.S. flag, stethoscope

Industry supportive of CMS move to tighten MA plans’ coverage

Feb. 5, 2025
By Mark McCarty
Medicare Advantage plans have drawn criticism for deviating somewhat from Medicare coverage policies, a question CMS took up in a recent draft rule. In comments to the docket, the Medical Device Manufacturers Association said it sees a need to throw a lasso around such practices, alleging that they may result in beneficiaries receiving more limited coverage than they would in fee-for-service care.
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Novo Nordisk to appeals court: Hurry up, please, on IRA challenge

Jan. 31, 2025
By Mari Serebrov
Now that Novo Nordisk A/S’ blockbuster semaglutide franchise has been selected as one drug for the next round of the CMS price negotiation, the Bagsværd, Denmark-based company is asking a U.S. appellate court to expedite its consideration of Novo’s challenge to the negotiations and the way CMS is implementing the program.
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Tablets on conveyor belt

Rx manufacturers caught between 340B, IRA requirements

Jan. 30, 2025
By Mari Serebrov
One of the uncertainties in the changing of the guard in both the U.S. administration and Congress is the future of 340B reforms. Now the Inflation Reduction Act makes reforms more critical than ever, as it requires manufacturers of drugs selected for price negotiations to certify that they’re giving 340B entities the lowest price, be it the 340B discount or the maximum fair price set by the CMS as part of the negotiation process.
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Study shows weight loss reduces spending; should GLP-1s be covered?

Jan. 23, 2025
By Karen Carey
A study published in Jama Network Open in December indicated a direct correlation between adult weight loss and reduced health care spending, suggesting that current glucagon-like peptide-1 receptor agonists (GLP-1RAs) should be reimbursed by Medicare and employer insurances for obesity and overweight conditions.
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US flag and HHS logo

Mum’s the word at US health agencies awaiting new leadership

Jan. 23, 2025
By Mari Serebrov
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
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Heart scientific overlay

Impulse Dynamics’ 2022 coverage petition for CCM finally surfaces

Jan. 23, 2025
By Mark McCarty
The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.
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Generic drugs and bottle

Drugsplaining: Teva details price negotiation impact on generics

Jan. 22, 2025
By Mari Serebrov
With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs.
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Health professional recording info from patient

CMS drafts guidance for use of real-world data in CED studies

Jan. 21, 2025
By Mark McCarty
Regulatory approval for medical products can rely on real-world data (RWD) typically only for expanded indications for use, but payers have been missing in action where this data source is concerned. The U.S. CMS has floated a guidance to facilitate the use of RWD in coverage decisions, providing a long-overdue update to Medicare clinical trial policy.
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Dollar sign inside vial, syringe

CMS’ price negotiations take two: Ozempic, Xtandi among 15 drugs chosen

Jan. 17, 2025
By Karen Carey
In the final days of the Biden administration, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) laid out the latest 15 drugs that are subject to negotiated prices, with Novo Nordisk A/S’ GLP-1 drug Ozempic for type 2 diabetes topping the list, bringing Rybelsus and Wegovy along for the ride because they share the same active ingredient, semaglutide.
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