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Home » Topics » Regulatory » CMS

CMS
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U.S. Capitol building

Senate takes up bill for Medicare coverage of breakthrough devices

Dec. 9, 2024
By Mark McCarty
Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining the Ensuring Patient Access to Critical Breakthrough Products Act for potential passage in the lame duck session – a development that would draw enthusiastic cheers from industry.
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Bluebird, Vertex reach Medicaid agreement on sickle cell therapies

Dec. 4, 2024
By Mari Serebrov
The U.S. CMS has negotiated outcomes-based agreements with Bluebird Bio Inc. and Vertex Pharmaceuticals Inc. to make their costly sickle cell gene therapies the first treatments to become available through the voluntary Medicaid Cell and Gene Therapy Access Model.
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Historic or empty gesture? CMS proposes covering obesity drugs

Nov. 26, 2024
By Mari Serebrov
When U.S. CMS Administrator Chiquita Brooks-LaSure announced Nov. 26 that the agency is “reinterpreting” the law in proposing a rule allowing Medicare and Medicaid to cover obesity drugs beginning in 2026, she called it a “historic step.” The rule, if finalized, could make obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) available to millions more Americans and further invigorate development of other obesity drugs. But given the lateness of the day in the Biden administration, the proposal may be more symbolic than historic.
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Hand holding ballot over box, US flag backdrop

Impact of 2024 election on med tech difficult to forecast

Nov. 15, 2024
By Mark McCarty
Makers of devices and diagnostics face a new set of policy questions following the 2024 U.S. general elections, but many of the impending changes at the executive branch seem directed more toward drugs and vaccines, seemingly leaving the device and diagnostics industries largely out of harm’s way.
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Eko Health Low EF Stethoscope

CPT code just the start of Eko’s coverage push for Sensora

Nov. 14, 2024
By Mark McCarty
Eko Health Inc. recently won a category III CPT code for its Sensora platform for cardiovascular disease detection. While a “cat III” CPT code hasn’t traditionally excited industry, the company is convinced that payers will respond because of the massive costs associated with cardiovascular disease.
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Cleerly Labs product suite

Cleerly scores win with four-MAC coverage of AI-QCT

Nov. 13, 2024
By Mark McCarty
Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.
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Medicare puzzle

US CMS lauded, blasted for physician fee final rule for 2025

Nov. 5, 2024
By Mark McCarty
Medicare coverage of digital mental health therapies has traditionally been lacking, but the final Medicare physician fee schedule for 2025 added three new codes to deal with the coverage gap.
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US-capital-washington-congress-government.png

Congress poised to revisit site-neutral payment

Nov. 5, 2024
By Mark McCarty
While the inpatient and outpatient final rules for 2025 are baked into the U.S. Medicare payment system, there are indications that Congress will consider legislation that would flatten rates across sites of service.
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CMS logo and website

CMS opts for separate pass-through categories for renal denervation

Nov. 4, 2024
By Mark McCarty
The U.S. Medicare outpatient final rule affirms several new devices for the new technology pass-through program, but one of the more significant findings is that CMS will use separate payment mechanisms for two renal nerve denervation devices, following the blueprint the agency employed for this question in the inpatient final rule.
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Gold dollar sign and gray question marks

Uncertainties plague short-term ‘win’ of US price negotiations

Oct. 25, 2024
By Mari Serebrov
If the maximum fair prices the U.S. CMS announced after the first round of drug price negotiations are any indication, advocates of the government price setting may be settling for short-term wins at the cost of long-term, more sustainable price reductions driven by competition.
Read More
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