MITA Testifies at HHS Public Meeting: Provisional CMS Coverage of

FDA-Approved Technologies Will Spur Clinical Innovation

Washington, DC, June 20, 2019 --(PR.com)-- 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:

- Make the coverage process more transparent, accountable, predictable, and collaborative;
- Use available alternate resources, including externally collected data, to make determinations of
“reasonable and necessary”;
- Grant provisional coverage to new technologies which have FDA clearance/approval; and
- 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

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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.”

The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of
medical imaging equipment manufacturers, innovators, and product developers. It represents companies
whose sales comprise more than 90 percent of the global market for advanced medical imaging
technology. For more information, visit www.medicalimaging.org. Follow MITA on Twitter
@MITAToday.-----

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Contact Information:
Medical Imaging and Technology Alliance
Tracy Cullen
703.841.3282
Contact via Email
https://www.medicalimaging.org/

Online Version of Press Release:

You can read the online version of this press release at: https://www.pr.com/press-release/787942

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