House committee approves bills to make obesity drugs and breakthrough devices covered by Medicare

Bills that would extend Medicare coverage to two categories of treatments — anti-obesity drugs and “breakthrough” medical devices — have cleared a House committee, moving them a step closer to passage.

The Treat and Reduce Obesity Act, which would expand Medicare coverage to include anti-obesity drugs for some beneficiaries, passed the House Ways & Means Committee by a vote of 36 to 4. The measure would provide coverage for anti-obesity drugs under Medicare Part D for elderly patients who switch to Medicare and are currently treated with such drugs. Currently, Part D plans prohibit coverage for obesity drugs. Without that coverage, an estimated 1.25 million patients would lose insurance over the next decade as they switch to Medicare, according to the committee’s projections.

Meanwhile, the Ensuring Patient Access to Critical Breakthrough Products Act passed the committee by a vote of 36 to 5. The bill would require Medicare to cover the cost of FDA-approved breakthrough devices for 4 years while CMS and the manufacturer work to establish permanent coverage.

“American innovation has produced some of the greatest medical breakthroughs in the world, saving countless lives while improving the quality of life for millions,” committee chairman Rep. Jason Smith (R-Mo.) said in his opening statement. “We can not only help Americans live healthier lives, but also lower long-term health care costs.”

Medical devices that treat or diagnose life-threatening or debilitating conditions for which there is currently no treatment, or devices that offer significant benefits over existing alternatives, can receive “breakthrough” designation from the FDA, Rep. Suzan DelBene (D-Wash.), one of the bill’s co-sponsors, said in a news release. However, it takes an average of five years after approval for such devices to be covered by Medicare.

“Older adults should not have to wait years for safe, effective treatments that can save their lives,” DelBene said in a release. “Our legislation, which passed the House Ways & Means Committee with a strong bipartisan vote… is a major step forward to drive innovation and investment in cutting-edge technology while removing barriers to care. By ensuring that Medicare covers breakthrough medical devices, we are improving the lives of millions of older adults and giving them new hope.”

Bruce Quinn, M.D., Ph.D., a health policy consultant in Los Angeles, agreed. “This legislation would be a good idea, supported by the wide majority with which it passed in committee,” he said in an email to MedPage today“Currently, the CMS process is unpredictably slow, and decisions about local scope can take two years or more to arrive.”

Quinn also praised the bill’s inclusion of “specified” breakthrough devices, defined as “a breakthrough device for which no Medicare benefit category exists.” “A ‘specified breakthrough device’ is an unusually named policy that allows breakthrough devices to be covered even if they don’t have a prior benefit category,” he said. “This provides an excellent initial window for real-world evidence. These devices will be closely monitored and reported to Congress. Overall, this is a win-win situation for innovative companies, providers, and patients.”

The bill comes as CMS is in the process of developing its own policy on the issue. In January 2021, the agency published a final rule known as Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary.” The rule would grant accelerated Medicare coverage for up to 4 years for any breakthrough device designated by the FDA after it receives market authorization.

However, as Dr. Lee Fleisher, then-CMS chief medical officer, explained in a September 13, 2021 blog post, “a number of important issues were raised during the public consultation process, including concerns about the lack of information about whether the device would be beneficial or harmful to Medicare beneficiaries.”

He continued, “The rule also posed operational challenges for CMS when we were considering implementation. It would guarantee coverage for any device that has received FDA breakthrough designation and market authorization regardless of whether the device is appropriate and provides benefits to the Medicare population.” As a result, “CMS has decided to rescind the rule and study a new one.”

Then on June 27, 2023, the agency published Federal Register Proposed regulations for a Transitional Coverage for Emerging Technologies (TCET) program that would allow breakthrough devices to be covered for a 3- to 5-year period during which real-world evidence of device effectiveness would be collected and CMS would continue to work on a more permanent coverage policy.

The notice included an Aug. 28, 2023, deadline for submitting comments on the proposed rule, but a final rule has not yet been issued. CMS did not respond to a request for comment by press time.

AdvaMed, a trade group for medical device manufacturers, praised the bill — with a caveat. “This is a major step forward in policy that will make a big difference in the lives of Medicare beneficiaries,” Scott Whitaker, president and CEO of AdvaMed, said in a statement. “But it’s really important to include all health technologies, including diagnostic tests. We look forward to continuing to work with Congress to ensure that breakthrough diagnostics, like those that detect cancer and other serious diseases earlier, are included in the final legislation that Congress passes.”

“As we await CMS’s finalization of (the rule) that was repealed 1,215 days ago, it is reassuring to see Congress taking action on behalf of Medicare beneficiaries,” Whitaker added.

AdvaMed lamented CMS’s delay in the rulemaking process in a Feb. 29, 2024, letter to CMS Administrator Chiquita Brooks-LaSure. “CMS’s delay in finalizing TCET is puzzling,” Whitaker wrote. “The ability to establish a workable policy to ensure Medicare coverage for safe, effective, FDA-designated, and market-cleared breakthrough devices should be within the agency’s grasp.”

He noted that 81 breakthrough technologies authorized by the FDA “were effectively denied by CMS to Medicare beneficiaries for years because of CMS’s inaction. Beneficiaries are right to ask: Why, if the FDA has deemed a medical technology safe, effective, and groundbreaking that they may need, has Medicare denied them access to these breakthrough technologies for years?”