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BioWorld - Thursday, May 28, 2026
Home » Topics » Regulatory » CMS

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Medicare puzzle

Congress questions Medicare’s WISeR proposal

Aug. 14, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services proposed to use AI to cut down on abuse of the Medicare program, but several members of Congress have concerns about the notion, given that private payers have used AI to illegitimately deny services to their beneficiaries.
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Medicare puzzle

Congress questions Medicare’s WISeR proposal

Aug. 13, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services proposed to use AI to cut down on abuse of the Medicare program, but several members of Congress have concerns about the notion, given that private payers have used AI to illegitimately deny services to their beneficiaries.
Read More
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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Adopt MFN pricing or else, drug companies told

July 31, 2025
By Mari Serebrov
No Comments
President Donald Trump sent letters July 31 to the CEOs of 17 major drug manufacturers doing business in the U.S., giving them 60 days to comply with his May 12 executive order (EO) on most-favored-nation (MFN) pricing. The EO appealed to drug companies to undertake MFN pricing voluntarily to end the freeloading in which other developed countries pay, on average, three times less than Americans are charged for the same medicines.
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Boston Scientific - Watchman FLX

Cardiologists blast Medicare LAA closure draft

July 29, 2025
By Mark McCarty
The ink is barely dry on the draft Medicare physician fee schedule for 2026, but three cardiology societies blasted the draft for cutting rates for left atrial appendage closure procedures – a move they said needlessly endangers patients.
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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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Gears with regulatory words

Palmetto wary of Prelude’s, Exact Sciences’ test for DCIS

July 21, 2025
By Mark McCarty
Palmetto GBA of Columbia, S.C., issued a draft local coverage determination that provides coverage for biomarker testing to stratify a patient’s risk associated with ductal carcinoma in situ.
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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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Document illustration

CMS proposes again to end IPO list in outpatient draft

July 16, 2025
By Mark McCarty
For the second time in five years, the Centers for Medicare & Medicaid Services (CMS) has proposed to erase the inpatient-onlylist over a span of three years, stating that physicians are capable of deciding which site of service is best for their patients.
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CMS’ gene therapy access model goes live, with 33 states on board

July 16, 2025
By Jennifer Boggs
No Comments
A total of 33 states, plus the District of Columbia and Puerto Rico, agreed to participate in the U.S. CMS’ voluntary, outcomes-based program aimed at helping state Medicaid programs cover high-priced cell and gene therapies, starting with therapies for sickle cell disease.
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