MITA backs provisional coverage of FDA-approved tech at HHS meeting

The Medical Imaging & Technology Alliance (MITA) argued that CMS should grant provisional coverage to FDA-approved new technologies to help determine reimbursement strategies and spur clinical innovation during a June 20 public hearing assembled by the Department of Health and Human Services (HSS).

“New technologies that are approved by the FDA but not reimbursed by CMS face a classic ‘Catch 22’,” Mark Carol, MD, chair of MITA’s Focused Ultrasound Section, said in a statement. “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.”

Carol, also CEO of SonaCare in Charlotte, North Carolina, laid out four recommendations to ensure patients have better access to new technologies and help prevent innovative developments from falling out of the marketplace. They are listed below:

1. The coverage process should be more transparent, inclusive and standardized.

2. “Use available alternate resources, including externally collected data, to make determinations of ‘reasonable and necessary.’”

3. New FDA-approved technologies should receive provisional coverage.

4. “Assign an appropriate New Technology Ambulatory Payment Classification (APC) within 30 days of FDA clearance or approval.”

Carol cited partial gland prostate ablation as a prime example of how a potentially life-saving technology can fall between the cracks of FDA approval and CMS reimbursement. The procedure was authorized by the FDA, but a lack of reimbursement forces patients to pay for treatment out of their own pockets. This limited utilization also makes it difficult to gather data needed for CMS to make a reimbursement decision. 

“By initiating this process, the administration is taking an important first step toward bridging the divide between the FDA and CMS,” 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.”