MITA Testifies at HHS Public Meeting: Provisional CMS Coverage of FDA-Approved Technologies will Spur Clinical Innovation

06.20.19

Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) today affirmed its view that the U.S. Centers for Medicare and Medicaid Services (CMS) should grant provisional coverage to new technologies that have Food and Drug Administration (FDA) approval for two years to validate the reasonableness and necessity of these innovations and obtain stakeholders to collect sufficient data to determine an appropriate reimbursement payment.

At a public hearing convened by the Department of Health and Human Services (HHS) to assist in developing “programs and procedures for assessing and accelerating the pace of the clinical innovation enterprise throughout the United States,” Dr. Mark Carol, CEO of SonaCare based in Charlotte, North Carolina and Chair of MITA’s Focused Ultrasound Section, laid out four recommendations to improve patient access to innovative technologies and to help prevent a technology from languishing or disappearing all together from marketplace:

  1. Make the coverage process more transparent, accountable, predictable, and collaborative;
  2. Use available alternate resources, including externally collected data, to make determinations of “reasonable and necessary”;
  3. Grant provisional coverage to new technologies which have FDA clearance/approval; and
  4. Assign an appropriate New Technology Ambulatory Payment Classification (APC) within 30 days of FDA clearance or approval.

“New technologies that are approved by the FDA but not reimbursed by CMS face a classic ‘Catch 22’,” said Dr. Carol. “They are approved but not covered by Medicare­ forcing patients to pay out of pocket. As a result, the procedure’s use is hindered, and the amount of clinical data needed for Medicare coverage can’t be generated. This disconnect between the FDA and CMS leaves innovative and proven technology in the laboratory and not in the clinic where patients can benefit from it.”

Dr. Carol shared with the panel the example of “partial gland prostate ablation” procedure as a case study on how innovative technology can languish between FDA approval and CMS reimbursement. The FDA-authorized procedure uses ultrasound to target diseased regions, treat those regions by thermally ablating targeted tissue and then tracks the impact of treatment using advanced signal processing tools. The result is the destruction of cancer while sparing healthy tissue and limited to no compromise in quality of life for the patient.

Lack of Medicare reimbursement, Dr. Carol noted, means patients must pay for the treatment out of pocket and the high-cost is a high barrier to overcome that limits access for many. Limited access and utilization also make it difficult to collect sufficient data needed to convince CMS to initiate a coverage decision. The result, in this case, is that a minimally invasive, cost-effective treatment is unavailable to many patients who would benefit.

“By initiating this process, the administration is taking an important first step toward bridging the divide between the FDA and CMS,” Dr. Carol said. “I applaud HHS for recognizing how patients can benefit from spurring clinical innovation and hope our recommendations rooted in transparency, collaboration and accountability can assist the agency as it pursues these important goals.”

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