Coalition of 33 organizations endorses CMS' proposal to quickly cover new medical devices

The American Telemedicine Association, the College of Healthcare Information Management Executives (CHIME) and Otsuka America Pharmaceutical are among the groups in support of the Centers for Medicare & Medicaid Services' (CMS') plan to more quickly review novel medical devices for Medicare coverage.

The transitional coverage for emerging technologies (TCET) pathway proposed by CMS in June uses national coverage determination and coverage with evidence development to expedite Medicare coverage of FDA-designated breakthrough devices. It is designed to reduce manufacturer burden and help patients and physicians make better healthcare decisions.

The pathway supports the “responsible use of digital and connected health technologies,” according to a letter signed by the organizations. They say clinical evidence overwhelmingly shows that these technologies improve patient care, prevent hospitalizations, reduce complications and improve patient engagement while lowering costs.

“Digital health tools offer the potential to fundamentally improve and transform American healthcare, particularly for the Medicare population,” the letter reads. “Unfortunately, despite the proven benefits of digital health technology to the American healthcare system, a range of statutory and agency-level restrictions inhibit their use. Today, attaining even nominal device coverage takes, on average, nearly six years.”

The organizations also recommended more steps CMS should take—for instance, expanding eligibility to more than seven devices per year and requiring devices and diagnostics to be considered “equitably” for inclusion in TCET. They also want additional medical technologies, like software as a medical device products, to fall under this category.

Other groups supporting the pathway include Biocom California, the Digital Therapeutics Alliance, the Medical Society of Northern Virginia and ResMed.

CMS had hinted at a new pathway for medical devices under Medicare coverage in October when it wrote about its plans in the Journal of the American Medical Association. This iteration of the pathway comes after a Trump-era rule with similar goals was spiked in late 2021.