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BioWorld - Saturday, December 13, 2025
Home » Topics » Regulatory » CMS

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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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US flag and HHS logo

HHS, payers vow to fix prior authorization problem

June 24, 2025
By Mark McCarty
The Department of Health and Human Services and private payers have promised to streamline the controversial prior authorization processes in a bid to reduce the attendant controversies.
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Medicare puzzle

MedPAC sounds alarm over Medicare physician pay rates

June 23, 2025
By Mark McCarty
The Medicare Payment Advisory Commission advised Congress that inflation is taking a bite out of physician pay and Medicare payments may have to increase in order to preserve patient access to care.
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Lungs and bronchiole

CMS agrees to cover at-home ventilation for chronic respiratory failure

June 17, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services finalized a coverage policy for at-home ventilation for patients with chronic respiratory failure. The amended policy also establishes a series of criteria for coverage of ventilation for chronic obstructive pulmonary disease.
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U.S. flag on columned building

Advamed presses CMS to require MA plans to honor NTAP program

June 16, 2025
By Mark McCarty
Medicare Advantage plans have been controversial for several reasons, and the Advanced Medical Technology Association has now made the argument that the Centers for Medicare & Medicaid Services should require these plans to replicate the terms of the Medicare new technology add-on program.
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U.S. Capitol building

CMS posts RFI for digital health infrastructure

May 15, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services reported a request for information for a modernized digital health ecosystem that would presumably improve beneficiary access to digital health technologies.
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CMS logo and website
MDMA annual meeting

CMS vows to put more emphasis on MA plans’ prior authorization

May 2, 2025
By Mark McCarty
Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.
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CMS logo and website

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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