The Medical Imaging & Technology Alliance (MITA) and the Focused Ultrasound (FUS) Foundation have submitted comment letters largely supportive of the Centers for Medicare & Medicaid Services (CMS) proposed rule for the Medicare Coverage of Innovative Technology (MCIT) program. 

First announced in September of this year, the CMS proposed rule would create a Medicare coverage pathway that would expedite patients’ access to innovative medical devices with a U.S. FDA “breakthrough” designation. The proposal represents a much needed and long overdue regulatory update that will help eliminate the lag time between FDA approval of a device or drug and the subsequent provision of Medicare coverage following approval of FDA-designated breakthrough devices, MITA officials say. If finalized, the proposed rule would pair FDA breakthrough and CMS coverage to grant immediate, four-year Medicare coverage for medical devices or drugs deemed as “breakthrough.”

“For years, breakthrough medical technologies—despite having received FDA approval—have faced a sometimes years-long process before achieving Medicare coverage,” says Patrick Hope, executive director of MITA.

“This system creates a ‘Catch-22’ scenario in which, without adequate coverage or reimbursement, access to an FDA approved therapy is limited to only those who can afford to pay out-of-pocket,” Hope says. “Limited access means a limited ability to collect the same data needed to support reimbursement. The proposed rule would help eliminate this so-called ‘valley of death’ between FDA approval and subsequent Medicare coverage by giving beneficiaries faster access to breakthrough technologies that would otherwise be left in limbo.” 

“By eliminating the gap between FDA approval and Medicare coverage for innovative medical devices, the proposed MCIT pathway would provide more certainty to manufacturers, more tools in clinicians’ armamentarium to treat disease, and more universal treatment options for patients,” adds Jessica Foley, PhD, chief scientific officer at the Focused Ultrasound Foundation.

While supportive of the MCIT proposed rule, both MITA and the FUS Foundation outlined further recommendations to strengthen beneficiary access to innovative medical devices. For example, as discussed in the proposed rule, only a small number of technologies have received “breakthrough” marketing authorization by the FDA.

Recognizing that this policy leaves numerous medical solutions out, MITA and the Foundation urged CMS to develop a more expansive list of criteria for inclusion in the MCIT program beyond the “breakthrough” designation. Doing so would help ensure efficient market access for advanced imaging solutions and software, novel radiopharmaceuticals and contrast agents, and high-intensity focused ultrasound therapies.

“While only a small number of devices have received breakthrough marketing authorization by the FDA, there are many other promising innovative devices that may not meet the stringent definitions for a breakthrough,” says Foley. “We urge CMS to expand the criteria for acceptance to the MCIT program to include more universal coverage of noninvasive medical devices including focused ultrasound that may be strongly preferred by patients as compared to more invasive alternatives.”

MITA also recommended that CMS update the definition of the “reasonable and necessary” criteria under which the agency determines whether or not to cover a product or service. In the proposed rule, CMS proposes to create a separate basis under which an item or service would be considered “appropriate” based on commercial health insurers’ coverage policies.

Pointing out that private payer coverage policies can vary widely regarding the medical technologies and populations they cover, MITA urged the agency to develop coverage policies based on transparent and high-quality data sources and evaluation methods. As the letter notes, “there may not in all cases be a simple crosswalk between these [commercial insurers’] policies and a unitary CMS coverage determination.”