May 31, 2022 This Week in Health Policy for May 30 This Week (May 30-June 3) Congress will be in recess this week. This Week in Health Policy will return on June 10th. Last Week (May 23-27) Health Care Highlights Latest efforts to address infant formula shortage. On Tuesday (May 24), the Food and Drug Administration (FDA) announced a deal to import two million cans of formula from United Kingdom-based infant formula manufacturer Nutricare. Those cans are expected to hit the shelves in June. On Thursday (May 26), the FDA announced about 500,000 cans of specialized medical formula would be imported from Danone’s Nutricia business. On Wednesday (May 25), FDA Commissioner Robert Califf told House subcommittee members that infant formula being domestically produced and imported into the United States will go to the hardest hit areas first and that pediatricians and consumers can get more information at HHS.gov/formula or by calling manufacturers’ hotlines. Meanwhile, the Federal Trade Commission this week said it will look into reports of online price gouging. Democrats seek bipartisan gun safety bill. In the wake of the mass shooting at a Texas elementary school, Senate Democrats are beginning to hold conversations about a possible bipartisan gun safety measure, such as mandating background checks or red-flag proposals that enable law enforcement to temporarily take guns from an individual who exhibits concerning behavior. Such a measure would likely face an uphill battle in the Senate where Republicans and a few Democrats have been reluctant to support new gun safety measures. At the same time, Department of Health and Human Services (HHS) Secretary Xavier Becerra called on “states to address the mental health of our kids” in the wake of the incident. Children’s mental health also has been a focus in Congress with several committees aiming to draft a bipartisan mental health package by the summer. Status of reconciliation talks. This week, Senate Majority Leader Chuck Schumer (D-NY) and Senator Joe Manchin (D-WV) have reportedly continued to meet over a possible slimmed-down reconciliation bill. Unconfirmed descriptions of a framework for a bill have been circulating in Washington that outline about $210 billion to extend Affordable Care Act subsidies set to expire at the end of the year, $320 billion for clean energy tax credits, and $120 billion for Child Care Development block grants. The proposal would be paid in part by $300 billion in revenue from prescription drug savings along with $1 trillion in tax revenues. Spending and deficit reduction would be split 50-50. Democrats now appear to be eyeing August as a potential deadline for reaching an agreement, as the potential to complete a reconciliation expires at the end of September. FDA sets new dates for COVID-19 vaccine advisory committee meetings. On Monday (May 23), the FDA announced new dates for its advisory committee meetings on COVID-19 vaccines for children. The agency said advisory committee will meet June 14 to discuss Moderna’s Emergency Use Authorization (EUA) request for children ages 6 to 17, and June 15 to discuss both Moderna’s EUA request for children 6 months to 5 years old and Pfizer-BioNTech’s EUA request for children 6 months to 4 years old. Surgeon General issues advisory on health care worker burnout. On Monday (May 23), U.S. Surgeon General Vivek Murthy issued a new advisory on health care worker burnout. The advisory details recommendations to address burnout and improve health care workers’ well-being. HHS publishes notice establishing ARPA-H. On Wednesday (May 25), the National Institutes of Health published a notice to formally establish the Advanced Research Projects Agency for Health (ARPA-H) within the agency effective May 24, 2022. The notice details the new research agency’s functions and organization. Also on Wednesday (May 25), HHS Secretary Xavier Becerra appointed Adam H. Russell to serve as acting deputy director of ARPA-H beginning in June. Hearings House Energy & Commerce Committee’s Subcommittee on Oversight and Investigations held a hearing on “Formula Safety and Supply: Protecting the Health of America’s Babies.” On Wednesday (May 25), the House Energy & Commerce Oversight and Investigations Subcommittee held an investigative hearing on “Formula Safety and Supply: Protecting the Health of America’s Babies.” During the hearing, committee members raised concerns about the events that have led to the current infant formula shortage, including the Biden administration’s and the FDA response, limited competition in the market, and actions taken by infant formula manufacturers. Lawmakers heard testimony from two panels of witnesses: the first comprised of FDA leaders and the second comprised of leaders from the nation’s three leading infant formula manufacturers.
Senate Health Education and Labor Committee held a hearing on “Infant Formula Crisis: Addressing the Shortage and Getting Formula On Shelves.” On Thursday (May 26), the Senate Health Education and Labor Committee held a hearing on the infant formula shortage. During the hearing, lawmakers heard testimony from FDA Commissioner Robert Califf on the events leading up to the current formula shortage. Lawmakers questioned Califf about delays in FDA processes and steps the FDA is taking to ensure a safe supply of infant formula in the United States.
Reports, Studies, and Journals AHIP and Blue Cross Blue Shield Association. More Than 2 Million Surprise Bills Avoided During January-February 2022. The survey estimated the No Surprises Act averted more than two million potential surprise medical bills across commercially insured individuals in the first two months of 2022. JAMA: Association of Inappropriate Outpatient Pediatric Antibiotic Prescriptions With Adverse Drug Events and Health Care Expenditures. The study found inappropriate antibiotic prescribing increased children’s risk of developing a potentially life-threatening infection by up to eight times. The authors also found that improper prescribing increased health care costs for patients by $74 million in 2017. NORC at the University of Chicago: COVID-19 Excess Deaths in Medicare. The data show older patients with obesity, Alzheimer’s disease, and mental health conditions were more likely to die of COVID-19 than older patients with respiratory diseases or cancer. ———————————————
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