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BioWorld - Saturday, April 4, 2026
Home » Topics » Regulatory » CMS

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Lungs and bronchiole

CMS eyes ventilation coverage for beneficiaries with COPD

March 12, 2025
By Mark McCarty
Medicare beneficiaries in the U.S. diagnosed with chronic obstructive pulmonary disease (COPD) may soon be covered for positive pressure ventilation in the home per a draft coverage memo from CMS.
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Pills arranged in dollar sign

Bill could have epic impact on drugs selected for negotiations

March 10, 2025
By Mari Serebrov
Several drugs already selected for Medicare price negotiations, including Novo Nordisk A/S’ mega-blockbuster diabetes/weight-loss franchise, could see up to a three-year reprieve if a bipartisan bill recently introduced in the U.S. House and Senate becomes law.
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New admin toes the Biden line on Rx price negotiations

Feb. 25, 2025
By Mari Serebrov
The Trump administration dashed hopes that it would temper the Medicare price negotiations mandated by the Inflation Reduction Act when it filed the government’s brief in response to Novartis AG’s appeal to the U.S. Court of Appeals for the Third Circuit.
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Heart scientific overlay

MDMA calls for TTVR coverage to include expanded indications

Feb. 10, 2025
By Mark McCarty
The U.S. national coverage analysis for transcatheter tricuspid valve replacement drew support from cardiologists and device makers alike, but the Medical Device Manufacturers Association is urging CMS to plan ahead in its final coverage memo and consider the coverage needs outside the confines of the existing U.S. FDA-approved device.
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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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