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BioWorld - Wednesday, February 4, 2026
Home » Topics » Regulatory » CMS

CMS
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Edwards seeks a TAVR two-fer in Medicare coverage petition

Dec. 16, 2025
By Mark McCarty
Edwards Lifesciences Corp., of Irvine, Calif., petitioned the Centers for Medicare & Medicaid Services to revise the Medicare coverage policy for transcatheter aortic valve replacement (TAVR) devices on two points, the combination of which would make a big difference for TAVR devices across manufacturers. Edwards requested that CMS explicitly cover TAVR for asymptomatic aortic stenosis patients, a notion well supported by recent data, and bring an end to the coverage with evidence development mandate.
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US senators want the lowdown on Trump biopharma pricing deals

Dec. 15, 2025
By Mari Serebrov
No Comments
A group of eight Democratic senators is asking biopharma companies to spill the beans about their private most-favored-nation pricing deals with U.S. President Donald Trump. Led by Sen. Ron Wyden, D-Ore., ranking member of the Senate Finance Committee, the senators sent letters Dec. 11 to Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Pfizer Inc. seeking the details of those deals. While it’s difficult to discern how the deals will benefit patients, it’s clear the companies stand to gain a lot from the agreements, the letter asserted.
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Medicare puzzle

Medicare’s competitive bidding program draws opposition

Dec. 2, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders.
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White tablet imprinted with dollar sign

Gimme shelter: Neurocrine, Lilly spared in CMS price cut fallout

Nov. 26, 2025
By Randy Osborne
No Comments
The U.S. Centers for Medicare & Medicaid Services (CMS) rolled out negotiated costs of the second batch of drugs subject to such bargaining under the Inflation Reduction Act. Wall Street was not surprised to learn that the numbers amount to much greater cuts than the Biden administration managed for 2026. CMS said the adjusted maximum fair prices would have achieved 44% lower net spending had they been implemented in 2024 – 36% if forgiven discounts from the part D redesign of the Medicare prescription drug benefit are figured in. Fifteen drugs are listed.
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Medicare puzzle

OIG sees potential for savings in Medicare CGM coverage

Nov. 26, 2025
By Mark McCarty
The Office of Inspector General issued a report stating that the Medicare program could save “tens of millions of dollars” in a single year on continuous glucose monitors and associated supplies if the Centers for Medicare & Medicaid Services acted to apply price pressure on suppliers.
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CMS logo and website

Cardiology societies laud Medicare coverage of EP procedures at ASCs

Nov. 26, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services will cover certain cardiac electrophysiology procedures in ambulatory surgical centers in 2026. This change which drew the support of both the Heart Rhythm Society and the American College of Cardiology, which could increase device utilization.
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CMS logo and website

CMS terminates Treatment Choices model in ESRD final rule

Nov. 25, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services ended the Treatment Choices model under the end stage renal disease payment payment system for several reasons, including its failure to deliver meaningful savings.
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CMS logo and website

CMS finalizes plan to do away with inpatient-only list

Nov. 24, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services released the 1657-page final rule for inpatient payment for calendar year 2026, a document chock full of important policy decisions including a renewed call for elimination of the inpatient-only list.
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US Capitol at night

PAMA cuts for clinical lab testing averted, but overhang remains

Nov. 20, 2025
By Mark McCarty
The resolution of the budget impasse between Democrats and Republicans on Capitol Hill sidestepped a number of problems, including some cuts to Medicare payment rates for clinical laboratory testing services. However, that pause is only in effect through the end of January 2026, leaving operators of these labs with a fiscal sword of Damocles to manage.
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Money and pills

Partisan rhetoric heats up in Rx price-lowering jousting

Nov. 19, 2025
By Mari Serebrov
No Comments
In a verbal sparring over who can deliver the lowest drug prices in the U.S., several Senate Democrats are urging President Donald Trump to immediately release the list of second-round Medicare-negotiated drug prices, instead of doing what they characterize as “ambiguous” and “opaque” pricing deals with individual biopharma companies.
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