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Home » Topics » Regulatory » CMS

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Industry not placated by changes to US negotiations guidance

June 26, 2023
By Mari Serebrov
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act.
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DNA in test tubes

OIG sees holes in Medicare administration of claims for gene testing services

June 26, 2023
By Mark McCarty
The U.S. Office of Inspector General (OIG) has concluded an analysis that found fault with Medicare payments for genetic testing under CPT code 81408, a code that covers tests for a variety of mutations of medical interest. According to OIG, these claims were often paid $2,000 each despite poor oversight from Medicare administrative contractors (MACs), raising the risk that a substantial percentage of roughly $888 million in claims paid between 2018 and 2021 were either fraudulent or at best inappropriate.
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U.S. flag, stethoscope

US CMS wants earlier notification from manufacturers in revamp of TCET

June 26, 2023
By Mark McCarty
U.S. Medicare coverage for breakthrough devices has been a hot topic for several years now, but industry is one step closer to making this policy dream a reality thanks to another new proposal from the Centers for Medicare & Medicaid Services (CMS). The agency released a new version of the Transitional Coverage for Emerging Technologies (TCET) program that seems to satisfy most of what med-tech trade associations sought, but the catch is that manufacturers must notify CMS of their intent to take part in TCET a year before the FDA will decide whether to grant market authorization to the device.
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Senior eye exam

Medicare administrative contractors take dim view of several glaucoma technologies

June 12, 2023
By Mark McCarty
Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
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Powered wheelchair in hallway

US Medicare program renders ‘landmark’ coverage memo for seat elevation devices

June 7, 2023
By Mark McCarty
The U.S. CMS has wrapped up a coverage analysis for seat elevation systems that are accessories for power wheelchairs, but the agency went above and beyond the strict terms laid out in the proposed decision memo.
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US CMS flexes muscle in proposing Medicaid Rx pricing tools

May 24, 2023
By Mari Serebrov
The U.S. Centers for Medicare & Medicaid Services (CMS) is flexing its new authority in a proposed rule intended to clamp down on drug prices by providing more transparency in the Medicaid program.
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Leqembi

Pressure mounts for CMS coverage ahead of Leqembi’s ‘full’ approval date

May 22, 2023
By Mari Serebrov
As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes.
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Approved stamp

Armed with new tools, US FDA picks up pace of accelerated approvals

May 12, 2023
By Mari Serebrov
Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
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US lawmakers: Lengthy NCD process ‘not acceptable’

May 1, 2023
By Mari Serebrov and Mark McCarty
The U.S. Centers for Medicare and Medicaid Services’ years-long musing over a streamlined coverage policy specifically for breakthrough medical devices is now taking a toll on breakthrough medications that could provide a cure or arrest the progression of debilitating diseases.
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No political divide in frustration over CMS Alzheimer’s coverage

April 26, 2023
By Mari Serebrov
U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure made her first appearance April 26 before the House Energy and Commerce’s Subcommittee on Health, ostensibly to discuss legislative solutions to increase transparency and competition in health care. But member after member, regardless of political party, demanded answers about why CMS continues to severely restrict access to Eisai Co. Ltd.’s Alzheimer’s drug, Leqembi (lecanemab), especially since another government agency is covering it for all veterans that meet the labeling requirements.
Read More
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