CMS puts the brakes on breakthrough device coverage rule

CMS has postponed for 60 days the implementation of a final rule that would provide immediate Medicare reimbursement for devices authorized through FDA’s breakthrough device program, saying it could revise, further delay or even rescind the proposed action after considering additional public input.

The announcement follows President Joe Biden’s freeze on new regulations and comes just days after a group of physicians writing in the New England Journal of Medicine called for the pending breakthrough device coverage rule to be retracted. The government’s notice notes that and other critiques of the rule.

AdvaMed has been a vocal proponent of the Medicare Coverage of Innovative Technology rule and has urged the Biden administration to implement and strengthen the initiative.

CMS put the brakes on the MCIT rule that was due to take effect on March 15. The agency, under former administrator Seema Verma, issued the proposed regulation published in September and finalized it on Jan. 12. It is now postponed until May 15. The pathway is intended to improve access to new medical technologies for Medicare beneficiaries by offering simultaneous reimbursement coverage.

The rule would grant national Medicare coverage of breakthrough-designated devices for a four-year period beginning on the date of FDA market authorization. CMS would then re-evaluate the device based on clinical and real-world evidence of improved health outcomes at the end of four years to determine more permanent coverage.

Device manufacturers have long sought a faster path to Medicare coverage for new devices. Analysts lauded the final rule in January as potentially beneficial to device makers such as Abbott, Medtronic, Boston Scientific and Johnson & Johnson with breakthrough products.

AdvaMed CEO Scott Whitaker has been especially outspoken in support of the regulation, taking to Twitter in December to stress its importance to Medicare beneficiaries in a series of tweets. “Let me be clear: Without this MCIT rule, which has bipartisan support, senior patients may have no other effective options to save and improve their lives. That’s how serious it is,” he said.

Yet some critics of the plan have argued the rule could increase healthcare costs while supporting use of devices without rigorous evidence of safety and effectiveness. The rule would undermine Medicare’s authority to consider the clinical evidence supporting device adoption, doctors from Massachusetts Eye and Ear Infirmary, Yale School of Medicine and the University of California, San Francisco, said in an NEJM Perspective article published last week.

CMS addressed concerns about the MCIT pathway raised in the NEJM, and by others writing in the New York Times and Health Affairs, in its notice pushing back the rule’s effective date. Responding to challenges to its premise that MCIT coverage could improve care for Medicare beneficiaries, CMS said the final rule allows removal of a breakthrough device from the pathway when FDA issues a safety communication or warning letter or revokes market authorization for a product.

But the government’s notice also suggested some of the critiques made valid points.

“Because Medicare patients usually have more than one co-morbidity and are likely being treated for more than one condition, CMS has historically reviewed clinical evidence showing that the devices have been studied in the Medicare population or that outcomes are generalizable to the Medicare population,” the CMS notice says, reflecting some of the points made in the NEJM piece.

CMS said it is particularly interested in public feedback on operational issues, overlapping rules, breakthrough device volume, patient protection and commercial insurance coverage. The agency is providing a 30-day public comment period to gather public feedback during the rule’s delay.

The agency noted the rule does not directly address operational challenges such as how coding and payment levels for specific devices would be established, and it seeks feedback on how to resolve those issues. It also is looking for thoughts on how to integrate the MCIT rule with a separate Nov. 4 proposed rule on benefit category determinations for durable medical equipment.

A larger number of breakthrough devices may be eligible for the program than originally anticipated, and the regulatory impact of that growth also should be considered, CMS said. More than 400 devices have been designated as breakthrough as of mid-February, compared to 97 at the end of fiscal 2018.

The agency also said people commenting on the proposed rule wanted a clearer standard for covering MCIT breakthrough devices after the pathway ends and more detail on the impact of commercial insurance coverage. Medtech Dive