CMS Nominee: Dr. Oz

On the one hand, Mehmet Oz, MD, is a cardiac surgeon who co-invented the MitraClip percutaneous mitral valve repair device, helped develop left ventricular assist devices (LVADs), and has been involved in other medtech innovations. On the other hand, Dr. Oz is a TV personality who has used his very public platforms to tout false or unproven medical information, like bogus diet pills and claims that apple juice has dangerous levels of arsenic. 

Now, Trump says he plans to nominate him as administrator of CMS, where he would be responsible for running the Medicare, Medicare Advantage, and Medicaid insurance systems, including coverage, coding, and payment policies impacting medical technologies. How his divergent experiences—which, observers have pointed out, do not include running a large bureaucracy like the Medicare system—will feed into his leadership of CMS and impact medtech policies remains an open question.  

Oz unsuccessfully ran, with Trump’s endorsement, for a Pennsylvania Senate seat in 2022. His primary healthcare policy during the race was “Medicare Advantage for All,” essentially a form of privatized Medicare. Medicare Advantage plans, in which private insurers administer Medicare benefits plus some additional benefits, have been growing and now cover more than half of the Medicare population. Notably, that trend has presented a challenge to device companies, MDMA’s Mark Leahey underscored at the Innovation Summit. Even though MA plans are supposed to abide by all traditional fee-for-service Medicare coverage policies, in practice that doesn’t always happen. Private MA insurers often leverage prior authorization policies and other tools to block or delay procedures that would be covered by traditional Medicare. CMS recently finalized regulations that put MA plans under tighter scrutiny to align with Medicare coverage policies, and Leahey urged companies to hold the agency accountable. “Those of you out in the room who are seeing a big delta between your fee-for-service access for patients and the MA side, bring that to CMS' attention,” he said.

Generally, industry is pressing CMS to improve reimbursement pathways for new medical technologies. The agency under Dr. Oz would be responsible for rolling out the new Transitional Coverage for Emerging Technologies (TCET) coverage program for FDA Breakthrough Devices and potentially a more novel coverage pathway if industry is successful in lobbying Congress to pass the Ensuring Patient Access to Critical Breakthrough Products Act. More broadly, trade groups will be pushing CMS to improve transparency and predictability of its processes for all products, and they hope Dr. Oz’s medtech experience will be relevant. “Dr. Oz has firsthand experience with medical technology and as a result understands the incredible impact these technologies can have in the lives of patients in need,” AdvaMed’s Whitaker said.