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BioWorld - Thursday, December 18, 2025
Home » Topics » Regulatory » CMS

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CMS to hold advisory hearing for Parkinson’s devices​

April 29, 2025
By Mark McCarty
No Comments
The U.S. Centers for Medicare & Medicaid Services will hold an advisory meeting regarding devices for treatment of symptoms for Parkinson’s disease, but the agency indicated that it expects to see longer-term data for these treatments if manufacturers want Medicare coverage.
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Gears with regulatory words

Advamed AI policy document criticizes FDA’s AI PCCP guidance

April 23, 2025
By Mark McCarty
The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.
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CMS logo and website

CMS suspends skin substitute local coverage determinations

April 17, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services decided to peel back a series of local coverage determinations for skin substitute grafts that provoked a vigorous response from stakeholders.
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Doctor, female patient, stethoscope

AMA panel eyes CPT code for cardiac contractility modulation

April 16, 2025
By Mark McCarty
The American Medical Association’s CPT editorial panel will meet May 1-3 to consider codes for several devices and services, but the most important of these might be the code for cardiac contractility modulation.
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CMS logo and website

CMMI again under pressure as CMS closes several programs

April 15, 2025
By Mark McCarty
The Center for Medicare and Medicaid Innovation was founded with the objective of reducing Medicare spending, but many of the associated programs will be stood down by the end of this year thanks in part to a 2023 report detailing a significant increase, rather than a decrease, in spending associated with CMMI programs.
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Illustration of TAVR device

CMS disinclined to reassign TAVR procedures to higher-paying DRG​

April 14, 2025
By Mark McCarty
The U.S. Medicare draft inpatient rule for fiscal 2026 discusses a number of coding proposals, although the agency seems disinclined to go along with a proposal to increase payment rates for TAVR devices by switching the procedures to a different diagnostic-related group.
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Medicare puzzle

Gore petitions CMS to reassign DRG for thoracic branch devices

April 14, 2025
By Mark McCarty
The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure.
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Edwards Lifesciences - Evoque tricuspid valve replacement device

CMS rolls out draft coverage memo for TEER for the tricuspid valve

April 7, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) issued a draft coverage memo for transcatheter edge-to-edge repair for the tricuspid valve (T-TEER), which is a development that promises accelerated competition for this anatomical space.
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CMS rule ditches plan for Medicare coverage of obesity drugs

April 7, 2025
By Jennifer Boggs
A late 2024 CMS proposal to include obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) under Medicaid and Medicare didn’t make it far under the new U.S. administration. A final rule, set to be published in the Federal Register April 15, will not include the provision that would have added obesity drugs to Part D coverage beginning in 2026.
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CMS logo and website

US Senate confirms Mehmet Oz as CMS administrator

April 4, 2025
By Mark McCarty
Mehmet Oz won the U.S. Senate’s nod as the administrator of the Centers for Medicare & Medicaid Services. Oz brought in 53 aye votes to 45 nays in the Senate’s April 3 confirmation tally, and inherits a complicated task as the Medicare breakthrough devices coverage program continues to face substantial challenges.
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