Recommendation: The Commissioner of FDA should develop performance metrics and use them to evaluate the implementation of the least burdensome requirements, such as during its planned audits of medical device deficiency letters. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: In July 2019, FDA reported on efforts to increase device staff knowledge of least burdensome requirements and the implementation of a "least burdensome flag," which allows the submitter to flag a submission for FDA if it believes that the agency's request is not the least burdensome or that it was being held to an inappropriate review standard. In August 2020, FDA described its analysis of the flags, including the number of times it was used and the time it took to resolve them relative to FDA's goal. FDA indicated that it will continue to monitor the usage of the flag program to identify signals or trends that should be addressed. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: The Administrator of CMS should evaluate the possible costs and savings of using disposable devices that could potentially substitute for DME, including options for benefit categories and payment methodologies that could be used to cover these substitutes, and, if appropriate, seek legislative authority to cover these devices.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In March 2019, HHS included in its fiscal year 2020 budget a legislative proposal to extend Medicare coverage to disposable devices that could potentially substitute for DME in treating and managing diabetes. As of March 2020, CMS has not provided documentation of the evaluation of possible costs and savings that we recommended and that we believe underpins the legislative proposal. We will review this documentation once provided.

Recommendation: To ensure that FDA can effectively coordinate and integrate its medical product centers' programs and emerging issues, the Secretary of Health and Human Services should direct the Commissioner of FDA to engage in a strategic planning process to identify challenges that cut across the medical product centers and document how it will achieve measurable goals and objectives in these areas.

Agency: Department of Health and Human Services
Status: Open

Comments: FDA concurred with the recommendation and in September 2016 and January 2018 described steps it had taken toward strategic planning for its medical product centers. However, in June 2020, FDA informed GAO that there had been several senior leadership changes and its agency-wide strategic planning process was paused to focus on the covid-19 pandemic response. Officials also noted that FDA continues to address existing strategic priorities. We will update the status of this recommendation when we receive additional information.

Recommendation: To ensure that nonmedical DOD research organizations coordinate with the Assistant Secretary of Defense for Health Affairs early in the research process to understand medical research requirements and avoid inefficiencies that may lead to duplicative work, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to communicate to DOD's nonmedical research organizations the importance of coordination with the Joint Program Committee for Combat Casualty Care chair on combat casualty care issues, and require this coordination early in the research process when these organizations conduct research with implications for combat casualty care.

Agency: Department of Defense
Status: Open

Comments: DOD took several actions in 2014 to communicate to DOD's nonmedical research organizations the importance of coordination with the Joint Program Committee for Combat Casualty Care. Specifically, DOD chartered the Armed Services Biomedical Research Evaluation and Management Community of Interest to include both medical and non-medical researchers and to improve coordination, collaboration, and cooperation. DOD also appointed senior leaders to work in both this community of interest and in other DOD research communities of interest, to improve coordination. Furthermore, DOD conducted joint research meetings to share research data across the medical and non-medical communities. However, DOD had not indicated a requirement for this coordination to occur early in the research process, as included in GAO's recommendation. As of September 2019, DOD has not provided additional information or documentation to address this recommendation.