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BioWorld - Thursday, April 2, 2026
Home » Topics » Regulatory » CMS

CMS
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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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Telehealth illustration

CMS takes aim at skin substitutes, telehealth in 2026 doc fee draft

July 15, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has pulled off the gloves when it comes to spending on skin substitutes in the draft Medicare physician fee schedule for 2026, proposing a payment methodology that would slash spending by 90%. However, the doc fee draft also proposes to simplify the process by which telehealth coverage is provided for a physician service, a move that may significantly expand the types of services that can be handled without an in-office visit.
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Doctor with illustration of kidneys

CMS lists 6 specialists as part of hypertension team in RDN memo

July 15, 2025
By Mark McCarty
To the surprise of no one in the device industry, the Medicare national coverage analysis for renal denervation (RDN) includes both radiofrequency and ultrasound technologies, but the agency has listed a range of specialists to be part of the patient’s care team, including but not limited to an endocrinologist.
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Medicare puzzle

CMS formally proposes to terminate ESRD choices program

July 8, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services indicated it will act on a previous proposal to terminate the Treatment Choices Model for ESRD at the end of the current calendar year because of a failure of the program to deliver on the promised efficiencies and improvement in outcomes.
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3D heart in chest

CMS deletes two specialists to NCD final for tricuspid repair devices

July 3, 2025
By Mark McCarty
The final Medicare coverage memo for transcatheter edge-to-edge repair for tricuspid valve regurgitation largely replicates the April 2025 draft, but cardiology centers will not have to bring an electrophysiologist to the patient’s care team to be permitted to practice these devices.
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CMS logo and website

OIG presses CMS to act on overpayments related to global episodes

July 2, 2025
By Mark McCarty
The U.S. Office of Inspector General issued a report stating the Medicare program often pays for physician services that are not performed post-surgery, but the Centers for Medicare & Medicaid Services responded it is in no position to immediately begin tracking all excess payments under these global codes.
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CMS logo and website

CMS eyes competitive bidding for CGMs, insulin pumps

July 1, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services posted the draft home health rule for calendar year 2026, which includes a proposal to subject continuous glucose monitors and insulin pumps to competitive bidding, but the agency is also considering a more rapid pace of replacement of these technologies.
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Handshake with charts, maps, data

US agencies to assemble health care fraud data fusion system

July 1, 2025
By Mark McCarty
The U.S. Department of Justice reported June 30 that several hundred defendants were charged with health care fraud of more than $14 billion, but the more important news may be that federal agencies are standing up a data sharing system that will make this kind of enforcement more effective.
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Judge's gavel with US flag

Another court orders halt to US HHS reorganization

July 1, 2025
By Mari Serebrov
No Comments
Without using the words “universal” or “nationwide,” a U.S. district judge granted a preliminary injunction July 1 to stop the Department of Health and Human Services’ (HHS) reorganization plan, along with any workforce reduction that’s part of the plan.
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Illustration of TAVR device

NICE still wary of TAVR in moderate and low risk patients

June 27, 2025
By Mark McCarty
The U.K. National Health Service may or may not deploy transcatheter aortic valve replacement devices as widely as in the U.S., but the National Institute for Health and Care Excellence officially staked out the position the data are not yet compelling for anyone other than high risk patients.
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