May 8, 2023
This Week in Health Policy for May 8
This Week (May 8 - 12)
Senate Health, Education, Labor & Pensions Committee executive session on "The Need to Make Insulin Affordable for All Americans."
House Ways & Means Health Subcommittee will hold a hearing on "Examining Policies that Inhibit Innovation and Patient Access."
House Energy & Commerce Oversight and Investigations Subcommittee will hold a hearing on "Closing the Digital Divide: Overseeing Federal Funds for Broadband Deployment."
Senate Health, Education, Labor & Pensions Committee executive session on "CONTINUATION: S. 1067, S. 1114, S. 1214, and S. 1339."
Senate Finance Committee hearing on "Cross-border Rx: Pharmaceutical Manufacturers and US International Tax Policy."
Commerce, Science and Transportation Committee will hold a hearing on "The State of Universal Service."
House Energy & Commerce Health Subcommittee will hold a hearing on "Preparing for and Responding to Future Public Health Security Threats."
House Energy & Commerce Oversight and Investigations Subcommittee will hold a hearing on "Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains."
Last Week (May 1 - 5)
Health Care Highlights
CDC Director Walensky to resign. On Friday (May 5), Rochelle Walensky, the director of the Centers for Disease Control and Prevention, announced she will step down from her position in June. "The end of the COVID-19 public health emergency marks a tremendous transition for our country, for public health, and in my tenure as CDC Director," Walensky wrote. "I took on this role, at your request, with the goal of leaving behind the dark days of the pandemic and moving CDC — and public health — forward into a much better and more trusted place." It is not yet clear who will take over her role.
COVID-19 PHE ends next week as WHO ends global emergency. On Thursday (May 4), the World Health Organization (WHO) ended the COVID-19 global health emergency, saying it is time for countries to transition to treating COVID-19 as a routinely occurring disease. Similarly, the US government on May 11 is set to end the COVID-19 public health emergency, bringing to an end hundreds of waivers that health care providers and workers, states, agencies, payers, manufacturers and others across the supply chain have been operating under since 2020. On Monday (May 1), the Biden administration announced it will end remaining COVID-19 vaccination mandates, including those for federal workers, contractors and international air travelers, effective May 11, and that HHS will begin to end vaccine requirements for health care workers.
DEA to extend telehealth flexibilities. On Wednesday (May 3), the Drug Enforcement Administration (DEA) announced it has received a record 38,000 comments on its proposed telemedicine rules for prescribing controlled substances. In response, DEA said it has submitted a draft Temporary Rule to the Office of Management and Budget to temporarily extend the current flexibilities beyond the PHE. In a statement, DEA Administrator Anne Milgram said, "We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities while we work to find a way forward to give Americans that access with appropriate safeguards." Additional details will be included in the rule once it is published.
Surgeon General issues advisory on public health crisis of loneliness and isolation. On Wednesday (May 3), Surgeon General Vivek Murthy released a new Surgeon General Advisory warning of a public health crisis related to loneliness, isolation, and lack of connection. The advisory details a framework for a new National Strategy to Advance Social Connection.
FDA published draft guidance on decentralized clinical trials. On Tuesday (May 2), the Food and Drug Administration (FDA) published draft guidance for decentralized clinical trials, such as those conducted via telehealth. The draft guidance details potential design ideas and proposals for how to use digital health technologies to acquire data and partner with health care providers.
Hearings, Markups, and Other Committee Action
Senate Health, Education, Labor & Pensions Committee executive session on "S. 1067, S. 1114, S. 1214, S. _, Pharmacy Benefit Manager Reform Act." On Tuesday (May 2), the Committee convened to begin considering four bills related to pharmacy benefit manager reforms and increasing access to generic drugs. However, the session was cut short and lawmakers ultimately delayed votes on the measures after concerns were raised about moving forward without cost estimates from the Congressional Budget Office and before a May 10 hearing with leaders of insulin manufacturers and pharmacy benefit managers, among other concerns. The executive session is scheduled to reconvene on May 11.
Senate Finance Committee hearing on "Barriers to Mental Health Care: Improving Provider Directory Accuracy to Reduce the Prevalence of Ghost Networks." On Wednesday (May 3), the Committee held a hearing on so-called ghost networks and their impact on access to mental health care providers. During the hearing, lawmakers heard testimony from a panel of five witnesses representing patients, providers, and data management organizations. Lawmakers and witnesses stressed the need to improve the accuracy of health plans' provider networks, particularly for behavioral health care providers, and spoke about the challenges to maintaining accurate directories, as well as possible solutions. Several Republican members, including Ranking Member Mike Crapo (R-ID), spoke about identifying solutions that would not increase regulatory burdens, while Democrats and several witnesses spoke about the need for greater oversight of plan directories and enforcement mechanisms.
Senate HELP Committee hearing on "Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act." On Thursday (May 4), the Committee held a hearing on PAHPA reauthorization during which they heard from a panel of federal government leaders representing the Department of Health and Human Services' (HHS) Administration for Strategic Preparedness and Response (ASPR), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), and second a panel of academic and expert witnesses. The hearing largely focused on ways to update PAHPA to better prepare for future pandemics with the bulk of lawmakers' questions directed at the federal government leaders. HELP Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA) were the only two members to ask questions during the second panel and those questions focused on high prescription drug prices and the impact of potential cost controlling measures.
Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing on "A Review of the President's FY 2024 Funding Request and Budget Justification for the National Institutes of Health." On Thursday (May 4), the Subcommittee held a hearing to discuss the National Institute of Health's (NIH) FY 2024 budget request. Lawmakers heard from a panel of three NIH representatives and raised concerns about the budget's modest 1.7% increase for NIH programs, noting most of the proposed budget increase would go to the newly created Advanced Research Project Agency for Health and the cancer moonshot program.
Reports, Studies, and Journals
Congressional Budget Office: Long-Term Projections of Health Care Spending and the Implications for the Federal Budget. The CBO provides an overview of health care spending trends, as well as long-term projections and implications for the federal budget.
CDC: Provisional Mortality Data — United States, 2022. The report shows that US mortality rates fell by about 5.3% in 2022 compared with the previous year, with deaths from COVID-19 falling out of the top three causes of death in the US.
Kaiser Family Foundation: Half of All Eligible Medicare Beneficiaries Are Now Enrolled in Private Medicare Advantage Plans. The analysis of CDC data show 30.19 million of the 59.82 million people with both Medicare Part A and Part B were enrolled in a private plan in January 2023, marking the first time more than half of all eligible Medicare enrollees have a private MA plan.