Decentralized clinical studies – No later than one year after enactment, the Secretary shall issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices, including recommendations for how to advance the use of flexible and novel clinical trial designs and to help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse clinical population, including with respect to race, ethnicity, age, sex, and geographic location, when appropriate. The guidance shall be finalized no later than one year after closing the comment period on such draft guidance. This guidance will include considerations to advance the usage of telehealth to ensure the clinical study has a meaningful clinical population.
Modernizing clinical trials – To clarify the use of digital health technologies in clinical trials, the Secretary shall issue or revise draft guidance regarding the appropriate use of digital health technologies in clinical trials to help improve recruitment for, retention in, participation in, and data collection during, clinical trials, and provide for novel clinical trial designs utilizing such technology for purposes of supporting the development of, and review of applications for, drugs and devices.
Extending Acute Hospital Care At Home Waivers and Flexibilities – This section extends the Acute Hospital Care at Home initiative, as currently authorized under CMS waivers and flexibilities, through December 31, 2024. This includes the waiver of telehealth requirements under the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, Strengthening Public Health Act of 2022, such that an originating site shall include the home or temporary residence of the individual.
Special Registration for Telemedicine – The Committee supports efforts by the Drug Enforcement Agency (DEA) to enable health care providers to safely prescribe controlled substances remotely and to provide mechanisms that can be used to prevent illegal online drug sales and drug diversion. The Committee directs the DEA to promulgate final regulations specifying the circumstances in which a Special Registration for telemedicine may be issued and the procedure for obtaining the registration. For more background, see the Alliance’s advocacy
in this space.
Reports– To fully understand the impact of telehealth, the Committee requests reports from various Departments:
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