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Dr. Mehmet Oz, President Donald Trump’s nominee to lead the Centers for Medicare and Medicaid Services, told senators Friday that Medicare should cover newly approved medical devices more quickly to give beneficiaries earlier access to potentially life-saving technology.
Oz, who spoke before the Senate Finance Committee during his nomination hearing, criticized CMS processes he claimed can keep Food and Drug Administration-authorized medical devices from patients for years.
The comments came when Sen. Steve Daines, R-Mont., asked Oz if he would remove limitations on the CMS’ Transitional Coverage for Emerging Technologies program or create a new pathway that would speed the process for Medicare to cover new technology.
TCET is meant to expedite Medicare coverage for new medical devices once approved by the FDA. The program, which the CMS launched in August, replaced a pathway finalized in the closing days of the first Trump administration. The Biden administration rescinded that plan due to safety concerns, replacing it with the TCET final notice.
Advamed, one of the largest medical device lobbying groups, criticized the TCET pathway for being too limited — the notice stated that the CMS would accept five nominations annually for coverage. The agency claimed the number was due to a lack of available resources.
Daines made the same criticism of the program during the hearing, adding that the TCET pathway also “requires new clinical evidence for eligible devices, which can be duplicative for innovative technologies that have invested in robust clinical trials.”
Oz agreed that more could be done to speed up the Medicare coverage process for new technology. The heart surgeon and once-TV personality used his experience marketing MitraClip, a heart device to treat mitral valve regurgitation, as an example. Oz helped invent and holds a patent on MitraClip, which is now owned by Abbott.
MitraClip received a CE mark in 2008, Oz said, but it took five more years for the FDA to approve the device and another seven or eight years for Medicare coverage to kick in.
The federal government “should make it easier for industry to create life-saving tools by aligning when the FDA approves a product with when CMS begins to fund it for beneficiaries,” Oz added.
Lengthy wait times for Medicare coverage have been documented. The Stanford Byers Center for Biodesign found in a survey that, on average, it takes about five years after a device is authorized by the FDA to gain national Medicare and commercial insurance coverage.
Securing faster Medicare reimbursement for new products has been an industry priority for years. The Trump administration created a pathway to address the issue in early 2021, shortly before former President Joe Biden took office, called the Medicare Coverage of Innovative Technology.
When the CMS under the Biden administration moved to repeal the MCIT final rule, industry groups including Advamed tried to save it. However, the rule was ultimately axed in November 2021.
Advamed pressed the CMS to finalize the replacement TCET pathway; however, it had critics once the final notice was released last year. CEO Scott Whitaker said at the time that the pathway was a step toward stronger policy but it “doesn’t go far enough.”
“The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS,” Whitaker said. “And the exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection.”
Whitaker then called on Congress to pass legislation that would expedite Medicare coverage shortly after FDA approval of a device, called the Ensuring Access to Critical Breakthrough Products Act. The bill was introduced to the House of Representatives in March 2023 but has not advanced to the floor.
