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BioWorld - Tuesday, December 9, 2025
Home » Topics » Regulatory » Medicare

Medicare
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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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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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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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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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