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BioWorld - Friday, December 12, 2025
Home » Topics » Regulatory » Medicare

Medicare
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Medicare puzzle

Skin substitutes take a hit in Medicare doc fee final for 2026

Nov. 3, 2025
By Mark McCarty
The U.S. CMS has adopted an aggressive payment policy for skin substitutes in the Medicare physician fee schedule for 2026, although the payment rate is sufficiently higher than the agency had proposed to mollify some critics.
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Magnifying glass atop paperwork

OIG sees continuing problems with DME payments

Nov. 3, 2025
By Mark McCarty
The Office of Inspector General (OIG) said in a new report that the U.S. Medicare program had overpaid a group of providers of durable medical equipment (DME) by nearly $23 million between 2018 and 2024, an amount that is a significant drop from prior years, but which OIG said calls for further reforms for the Medicare DME program.
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BioFuture 2025: The challenge of accurate drug pricing

Oct. 15, 2025
By Lee Landenberger
No Comments
Government and market demands on companies and their pricing strategies have shifted dramatically in the past 10 years and the pricing landscape continues to change, creating uncertain ground beneath developers’ feet. At the BioFuture conference in New York, a panel discussed how big and small companies go about their pricing strategies and build educated guesses into how that strategy might work out in the market.
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Fiasp

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.
Read More
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