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BioWorld - Monday, February 23, 2026
Home » Topics » Regulatory » Medicare

Medicare
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IRA forecloses Novo Nordisk challenge to Medicare negotiations

Oct. 7, 2025
By Mari Serebrov
No Comments
Like the federal district court before it, the U.S. Court of Appeals for the Third Circuit said it lacks jurisdiction to rule on the merits of Novo Nordisk A/S’ claim that the CMS violated the Inflation Reduction Act (IRA) when it treated six of the company’s insulin aspart products as one negotiation-eligible single-source drug.
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Geneoscopy RNA-FIT-test

Geneoscopy seeks coverage for Colosense, but specificity a problem

Oct. 1, 2025
By Mark McCarty
The market for colorectal cancer screening tests seems poised to heat up considerably with a recent request for Medicare coverage for Genoscopy’s Colosense test, but some who commented on the proposal have misgivings about the lower level of specificity seen in the Colosense relative to the Cologuard.
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Medicare puzzle

Palmetto seeks to block coverage of electroporation for cancer

Sep. 30, 2025
By Mark McCarty
Palmetto GBA, the Medicare administrative contractor for most of the southeastern U.S., has opened a coverage analysis for the use of irreversible electroporation for a variety of cancers, but Palmetto has made it clear that it is unwilling to cover the procedure pending additional evidence.
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U.S. Capitol building

GAO acknowledges resource constraints in analysis of Medicare NCDs

Sep. 10, 2025
By Mark McCarty
The U.S. Government Accountability Office said in a recent report that the Medicare national coverage determination process could use a few adjustments, but the report also pointed to significant resource problems associated with the process, a source of drag that only Congress can fix.
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Medicare puzzle

Imbalance seen in skin substitute use for Medicare beneficiaries

Sep. 8, 2025
By Mark McCarty
The U.S. Office of Inspector General posted an analysis of Medicare spending on skin substitutes, remarking that the data suggest a disproportionate use of these products for patients enrolled in fee-for-service (FFS) care.
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US-health-flag-medicare.png

MedPAC anticipates doubling of Medicare spending by 2032

Aug. 21, 2025
By Mark McCarty
The Medicare Payment Advisory Commission said in a recent report that Medicare spending in the U.S. is poised to nearly double to $1.9 trillion over the coming eight years, a figure that is likely to apply ever-increasing price pressures on makers of devices, diagnostics and pharmaceuticals.
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US-health-flag-medicare.png

MedPAC anticipates doubling of Medicare spending by 2032

Aug. 20, 2025
By Mark McCarty
The Medicare Payment Advisory Commission said in a recent report that Medicare spending in the U.S. is poised to nearly double to $1.9 trillion over the coming eight years, a figure that is likely to apply ever-increasing price pressures on makers of devices and diagnostics.
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Medicare puzzle

TEAM proposal beefed up in Medicare inpatient final for FY 2026

Aug. 5, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services adopted several significant policy changes in the Medicare inpatient final rule for fiscal 2026, which includes a larger rate bump for hospitals than seen in the draft.
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CMS logo and website

CMS revisits coverage criteria for Parkinson’s, essential tremor

July 28, 2025
By Mark McCarty
An advisory committee for the U.S. Centers for Medicare & Medicaid Services endorsed a series of patient- and clinician-reported outcomes that might not be reflected in the evidentiary bases for currently available technologies. This development suggests some manufacturers will have to conduct new studies of their devices in order to sustain Medicare coverage.
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Heart and Optimizer Mini

Impulse Dynamics inches closer to Medicare coverage for CCM

July 17, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a draft coverage memo for cardiac contractility modulation (CCM), which offers coverage with evidence development for the company’s Optimizer line of devices. CMS said it will issue the final coverage memo by Oct. 8, 2025, which will mark the achievement of an objective the company set for itself more than two decades ago.
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