RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2019 > 8 > CMS Finalizes Path to Boost Reimbursement for Breakthrough Devices

CMS Finalizes Path to Boost Reimbursement for Breakthrough Devices

Posted 06 August 2019 | By Ana Mulero 

CMS Finalizes Path to Boost Reimbursement for Breakthrough Devices

The Centers for Medicare and Medicaid Services (CMS) finalized its April proposal to create an alternative new technology add-on payment pathway for medical devices with breakthrough device designation under the agency’s FY 2020 Inpatient Prospective Payment System (IPPS).
The new add-on payment model increases add-on payments for breakthrough devices from no more than 50% to 65%. The policy requires prior US Food and Drug Administration (FDA) approval or clearance in addition to breakthrough device designation from FDA. It also nixes the requirement for a device to demonstrate in advance that it substantially improves the diagnosis or treatment of Medicare beneficiaries compared to products already on the market.
CMS set forth the increases for breakthrough device payments and its changes to the coverage process as part of its IPPS proposed rule in April. Not included in the proposed rule is a new policy on add-on payments for FDA-designated qualified infectious disease products (QIDPs).
The final rule establishes new add-on payments of 75% for technologies that receive QIDP designations. CMS says it is introducing this policy “after consideration of public comments and concerns related to antimicrobial resistance and its serious impact on Medicare beneficiaries and public health overall.” QIDP technologies must receive FDA marketing authorization, too.
CMS will begin to apply the add-on payment increases with hospital discharges on or after 1 October. The policies aim to better facilitate Medicare beneficiaries’ access to new technologies.
“CMS is both shoring up hospitals’ ability to offer these life-changing innovations and sending a strong message throughout the innovation ecosystem that taking risks to develop new breakthroughs will be supported,” AdvaMed President and CEO Scott Whittaker said of the rule.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.