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BioWorld - Thursday, June 19, 2025
Home » Topics » Regulatory » CMS

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Medicare puzzle

Gore petitions CMS to reassign DRG for thoracic branch devices

April 14, 2025
By Mark McCarty
The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure.
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Edwards Lifesciences - Evoque tricuspid valve replacement device

CMS rolls out draft coverage memo for TEER for the tricuspid valve

April 7, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) issued a draft coverage memo for transcatheter edge-to-edge repair for the tricuspid valve (T-TEER), which is a development that promises accelerated competition for this anatomical space.
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CMS rule ditches plan for Medicare coverage of obesity drugs

April 7, 2025
By Jennifer Boggs
A late 2024 CMS proposal to include obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) under Medicaid and Medicare didn’t make it far under the new U.S. administration. A final rule, set to be published in the Federal Register April 15, will not include the provision that would have added obesity drugs to Part D coverage beginning in 2026.
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CMS logo and website

US Senate confirms Mehmet Oz as CMS administrator

April 4, 2025
By Mark McCarty
Mehmet Oz won the U.S. Senate’s nod as the administrator of the Centers for Medicare & Medicaid Services. Oz brought in 53 aye votes to 45 nays in the Senate’s April 3 confirmation tally, and inherits a complicated task as the Medicare breakthrough devices coverage program continues to face substantial challenges.
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CMS logo and website

Oz hits Wyden’s wall of skepticism in Senate CMS post hearing

March 25, 2025
By Mark McCarty
Mehmet Oz, the Trump administration’s pick to lead the U.S. Centers for Medicare & Medicaid Services (CMS), appeared for a second time in the Senate for the CMS administrator’s job.
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Medicare puzzle

Congress revisits the Medicare radiation oncology rate controversy

March 24, 2025
By Mark McCarty
The U.S. Medicare program took several bites out of rates paid for radiation oncology services under the physician fee schedule, but stakeholders are again gaining traction on Capitol Hill with a plea for intervention.
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Evoque valve sizes

US Medicare’s TTVR aligns closely with draft, T-TEER devices en route

March 20, 2025
By Mark McCarty
The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.
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Mehmet Oz, nominee for administrator of the Centers for Medicare & Medicaid Services

Oz promises AI, innovation, lower drug prices if confirmed to lead CMS

March 14, 2025
By Karen Carey
Cardiothoracic surgeon and television personality Mehmet Oz, President Donald Trump’s nominee for administrator of the Centers for Medicare & Medicaid Services (CMS), faced the U.S. Senate’s finance committee on March 14, suggesting the implementation of artificial intelligence (AI) technologies and the reduction of drug prices would be among his top priorities, if confirmed.
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Lungs and bronchiole

CMS eyes ventilation coverage for beneficiaries with COPD

March 12, 2025
By Mark McCarty
Medicare beneficiaries in the U.S. diagnosed with chronic obstructive pulmonary disease (COPD) may soon be covered for positive pressure ventilation in the home per a draft coverage memo from CMS.
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Pills arranged in dollar sign

Bill could have epic impact on drugs selected for negotiations

March 10, 2025
By Mari Serebrov
Several drugs already selected for Medicare price negotiations, including Novo Nordisk A/S’ mega-blockbuster diabetes/weight-loss franchise, could see up to a three-year reprieve if a bipartisan bill recently introduced in the U.S. House and Senate becomes law.
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