Medtech receiving a breakthrough device designation from FDA should be able to satisfy all of CMS’s non-cost criteria for transitional pass-through payments, according to the Medical Alley Association.
The Minnesota-based trade group’s CEO Shaye Mandle made the proposal in comments submitted Sept. 24 in response to a proposed rule from CMS to revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system.
CMS’s transitional pass-through payment program is meant to boost access to cutting-edge medical technologies.
A breakthrough device designation from FDA already allows a device creator to satisfy CMS’s “demonstrating a substantial clinical improvement” requirement for a transitional pass-through payment. Mandle at Medical Alley thinks it should satisfy all the other non-cost criteria, too. He noted that similar rules are already in place for TPT’s inpatient sister program, the New Technology Add-on Payment (NTAP).
“This will result in consistent access for patients to new technologies regardless of the setting in which they are treated and provide doctors with certainty when choosing a treatment plan,” Mandle said.
“Ensuring doctors and patients have access to the latest medical technology, while still preserving proper cost controls, is the core of both the TPT and NTAP programs. The breakthrough device designation is another piece of this and aligning these similarly motivated programs will results in better access, improved outcomes, and lower overall costs to patients.”
Mandle also proposed that CMS restrict Medicare Administrative Contractors (MACs) from making their own coverage decisions about medtech with TPT status — for the length of their eligibility.