ARPA-H Investment & HHS Conscience Rights: Health Care Weekly Review
TL/DR –
The US Department of Health and Human Services (HHS) released a final rule, Safeguarding the Rights of Conscience as Protected by Federal Statutes, and disclosed plans to launch a community-level preventative care program through ARPA-H. The HHS also introduced the Health Care Week in Review, a synopsis of the latest health care regulations, notices, guidance, and federal legislation news. Recent developments in the health care sector include FDA’s issuance of priority review vouchers for rare pediatric disease product applications, the NIH’s contemplation of granting an Exclusive Patent License for the development of HPV-positive cancer treatments, and SAMHSA’s solicitation of public comments on prevention and treatment of maternal mental health conditions.
Health Care Week in Review: Synopsis and Highlights
This article provides a concise summary of the latest developments in health care regulations, federal legislation, reports, studies, and other relevant news from Alston & Bird’s Health Care Week in Review. Major highlights include the release of a HHS rule titled, Safeguarding the Rights of Conscience as Protected by Federal Statutes and the announcement of a program through ARPA-H to invest in primary care by the Biden Administration.
I. Regulations, Notices & Guidance
The Food and Drug Administration (FDA) recently issued a notice regarding the issuance of a priority review voucher for the rare pediatric disease product CASGEVY, manufactured by Vertex Pharmaceuticals, Inc. The National Institutes of Health (NIH) also released a notice on the prospective grant of an exclusive patent license for T cell therapies for HPV-Positive Cancer(s) to Port Therapeutics, Inc.
Meanwhile, the Substance Abuse and Mental Health Service Agency (SAMHSA) requested public comments on maternal mental health and substance use disorders. HHS also issued a rule on safeguarding the rights of conscience as protected by federal statutes. Lastly, FDA published notices on viral safety evaluation of biotechnology products, requests for reconsideration at the division level under the Generic Drug User Fee Amendments, and a second priority review voucher for a rare pediatric disease product.
II. Upcoming Events
Several virtual and hybrid meetings have been announced by HHS, NIH, and other health agencies between January and March 2024. These meetings address a wide range of topics, including dietary guidelines, child health, Alzheimer’s research, autism research, heritable disorders in newborns, medical devices, minority health, and immunization practices. For a detailed list of upcoming events, refer to the original article.
III. Hearings & Markups
The House Committee on Education & the Workforce, Subcommittee on Health, Employment, Labor, and Pensions hosted a hearing on lowering costs and increasing access to health care with employer-driven innovation on January 11, 2024.
IV. Reports, Studies, & Analyses
A variety of reports have been published on health care related topics. These include a GAO report on VA Health Care, a KFF report on unwinding of Medicaid continuous enrollment, a BPC report on the future of remote patient monitoring, and a MedPAC report revealing the federal government is projected to overpay privately run Medicare Advantage plans by $88 billion in 2024.
V. Other Health Policy News
Stacy Sanders has been appointed as the Chief Competition Officer by HHS, a new role aimed at reducing healthcare and prescription drug costs. CMS has also announced the approval of an amendment to New York’s Medicaid section 1115 demonstration for improving access to primary care and health equity. Additionally, HHS has issued a final rule on safeguarding the rights of conscience as protected by federal statutes. Lastly, the Biden-Harris Administration has announced the launch of the Health care Rewards to Achieve Improved Outcomes (HEROES) program through the Advanced Research Projects Agency for Health (ARPA-H).
For the original source and more details, please refer to the complete article.
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