ASPS Comments on 21st Century Cures Discussion Draft
ASPS submitted comments last week to the House Energy and Commerce Committee on several provisions included in draft legislative language released as part of the 21st Century Cures Initiative. ASPS wrote in support of several components that will benefit its members and plastic surgery patients:
- Accelerating Innovation in Medicine – this provision, led by Rep. Erik Paulsen (R-Minn.), would establish a program that allows for patients to access medical device treatments sooner than otherwise would be available.
- Continuing Medical Education Sunshine Exemption – this portion of the bill, led by Rep. Michael C. Burgess, M.D. (R-Texas) and Rep. Peter DeFazio’s (D-Ore.), would clarify that peer-reviewed journals, journal reprints, journal supplements and medical textbooks are excluded from the reporting requirement under the Sunshine Act.
- Durable Medical Equipment – this provision, led by Rep. Renee Ellmers (R-NC), would create a new category of covered durable medical equipment, Substitute Disposable Medical Technology (SDMT), that can be used in an outpatient or home care setting.
- Global Surgery Services Rule – this language would prevent the implementation of the Centers for Medicare and Medicaid Services (CMS) plan to eliminate 10- and 90-day global surgery codes by converting all such codes to 0-day globals.
- Surrogate Endpoint Qualification and Utilization – this section, led by Rep. Cathy McMorris Rodgers (R-WA), would establish a process for FDA consideration of surrogate endpoints and support public-private partnerships to qualify biomarkers.