House Panel OKs Bills on Obesity Drug and Breakthrough Device Coverage in Medicare

Bills that would mandate Medicare coverage for two categories of treatments — anti-obesity drugs and “breakthrough” medical devices — have cleared a House panel, making them one step closer to passage.

The Treat and Reduce Obesity Act, which would expand Medicare coverage to include anti-obesity medication for some beneficiaries, passed the House Ways & Means Committee by a vote of 36-4. The measure would provide Medicare Part D coverage of anti-obesity drugs to patients aging into Medicare who are currently being treated by that type of medication. Currently, Part D plans prohibit coverage of obesity medications. Without this coverage, 1.25 million patients are projected to lose coverage over the next decade as they transition into Medicare, according to the committee.

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

“American innovation has delivered some of the world’s greatest medical breakthroughs that have saved countless lives while improving the quality of life for millions more,” committee chairman Rep. Jason Smith (R-Mo.), said in his opening statement. “We can [not only help] Americans live healthier [lives], but also bring down long-term healthcare expenses.”

Medical devices that either treat or diagnose life-threatening or debilitating conditions for which no treatment is currently available, or devices that offer significant advantages to existing alternatives, can receive a “breakthrough” designation by the FDA, Rep. Suzan DelBene (D-Wash.), one of the bill’s co-sponsors, said in a press release. However, it takes an average of 5 years after such devices are approved to implement Medicare coverage for them.

“Seniors shouldn’t have to wait years for safe and effective treatments that could save their lives,” DelBene said in the release. “Our legislation advanced by the House Ways & Means Committee with a strong bipartisan vote … is a great step toward driving innovation and investment in state-of-the-art technologies while removing barriers that hinder access to care. By ensuring Medicare covers breakthrough medical devices, we are improving the quality of life for millions of seniors and providing them with new hope.”

Bruce Quinn, MD, PhD, a health policy consultant in Los Angeles agreed. “This legislation would be a good idea, as supported by the wide margin with which it passed in committee,” he said in an email to MedPage Today. “The CMS process is currently unpredictably slow, and local coverage decisions can appear after a 2-year delay, or longer.”

Quinn also applauded the bill’s inclusion of “specified” breakthrough devices, defined as “a breakthrough device with respect to which no Medicare benefit category exists.” “The ‘specified breakthrough device’ is an unusually named policy by which breakthrough devices can be covered even if they don’t have a prior benefit category,” he said. “This provides an excellent initial period for real-world evidence. Such devices will receive careful tracking and reports to Congress. Overall, it’s a win-win for innovative companies, providers, and patients.”

The bill comes at a time when CMS is in the midst of developing its own policy on the matter. In January 2021, the agency published a final rule known as the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary.” That rule would have granted expedited Medicare coverage for up to 4 years for any FDA-designated breakthrough device once the device received market authorization.

However, as Lee Fleisher, MD, then CMS’s chief medical officer, explained in a Sept. 13, 2021 blog post, “many important considerations were raised through the public comment process, including concerns regarding lack of information as to whether the device would be beneficial or harmful to Medicare beneficiaries.”

In addition, he continued, “The rule also presented operational challenges to CMS as we considered implementation. It would have guaranteed coverage of any device that received FDA breakthrough designation and market authorization without consideration as to whether the device is appropriate and provides benefits for the Medicare population.” As a result, “CMS decided to repeal this rule and explore a new one.”

Then on June 27, 2023, the agency posted in the Federal Register a proposal rule for a Transitional Coverage for Emerging Technologies (TCET) program to allow for breakthrough devices to be covered for 3 to 5 years while real-world evidence of the device’s effectiveness is gathered and CMS continues to work on a more permanent coverage policy.

The notice gave a deadline of Aug. 28, 2023 to submit comments on the proposed rule, but no final rule has yet been issued. In response to a request for comment on the issue, a CMS spokesperson said in an email that the agency “is working expeditiously to issue a final TCET procedural notice.”

AdvaMed, a trade group for medical device manufacturers, applauded the legislation — with a caveat. “This is a major step forward on a policy that will make a big difference in the lives of Medicare beneficiaries,” AdvaMed president and CEO Scott Whitaker said in a statement. “But it is really important that all medical technologies, including diagnostic tests, are included. We look forward to working further with Congress to ensure breakthrough diagnostics, such as those that would detect cancer and other major diseases earlier, are in the final legislation that passes Congress.”

“As we continue to wait for CMS to finalize [the rule], which was repealed 1,215 days ago, it is reassuring to see Congress step up and take action on behalf of Medicare beneficiaries,” Whitaker added.

AdvaMed lamented CMS’s rulemaking delay 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 of safe, effective, FDA-designated and market-authorized breakthrough devices should be easily within the agency’s grasp.”

He noted that 81 breakthrough technologies authorized by FDA “have been effectively denied by CMS to Medicare beneficiaries for years through CMS inaction. Beneficiaries are right to ask: Why, if FDA has declared a medical technology safe, effective, and the kind of breakthrough they might need, Medicare denies them access to these breakthrough technologies for years?”

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