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Home » Topics » Regulatory » CMS

CMS
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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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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.
Read More
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