Home 5 News 5 New Bill Would Guarantee Medicare Coverage of Newly Approved Breakthrough Devices

New Bill Would Guarantee Medicare Coverage of Newly Approved Breakthrough Devices

by | May 9, 2023 | News, Open Content

Congress brings back controversial Trump plan scrapped by the Biden administration.

Lawmakers in the US House of Representatives recently tabled a bipartisan bill (H.R. 4043) that would require CMS to provide Medicare coverage of new medical devices that receive breakthrough device designation from the FDA for four years. The objective of the legislation is to ensure Medicare beneficiaries faster access to innovative products. But critics contend it would expose seniors to unproven devices.

Old Trump Wine in a New Congressional Bottle

The concept behind the Ensuring Patient Access to Critical Breakthrough Products Act isn’t novel. In August 2020, CMS proposed a rule requiring Medicare to cover medical devices that receive Section 510(k) breakthrough device designation for at least four years. The Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” rule would have recognized such devices as meeting the “reasonable and necessary” standard set out in Section 1862(a)(1)(A) of the Social Security Act for purposes of Medicare coverage. Meanwhile, CMS would have had to perform a new “reasonable and necessary” evaluation of the device based on clinical and real-world evidence of improved health outcomes. Once the initial four-year period ended, based on the results, the device would then have received:

  • An affirmative national coverage decision (NCD) from CMS;
  • A negative NCD from CMS; or
  • A coverage determination made by the Medicare Administrative Contractor (MAC) via local coverage determinations (LCD) or on a claim-by-claim basis.

H.R. 4043 is a revised version of the CMS proposed regulation. And it raises the same concerns that kept the rule from making it to fruition. First and foremost is the concern that automatic Medicare coverage of breakthrough devices would expose seniors to unproven and potentially dangerous products. Critics of the original CMS rule, including the bipartisan Medicare Payment Advisory Committee (MedPAC), pointed out that FDA breakthrough device and Medicare “reasonable and necessary” coverage criteria is an apples-to-oranges comparison requiring completely different forms of medical evidence. Moreover, MedPAC contends that forcing CMS to cover breakthrough devices would strip the agency of its independent scientific review responsibilities in deciding what Medicare should cover.

For these reasons, the Biden administration officially rescinded the CMS rule in November 2021. However, the fact that it’s Congressional legislation with bipartisan support gives H.R. 4043 a decent chance at passage.

For the full article, see the May 2023 issue of our Laboratory Industry Report.