May 23, 2022
This Week in Health Policy for May 23
This Week (May 23-27)
House Energy & Commerce Committee’s Subcommittee on Oversight and Investigations will hold a hearing on “Formula Safety and Supply: Protecting the Health of America’s Babies.”
Senate Health Education and Labor Committee will hold a hearing on “Infant Formula Crisis: Addressing the Shortage and Getting Formula On Shelves.”
Last Week (May 16-20)
Health Care Highlights
Federal government takes action on infant formula shortage. On Wednesday (May 18), President Joe Biden invoked the Defense Production Act to address the United States’ baby formula shortage, and announced his administration is working to use commercial airplanes to import formula from other countries. In addition, the Senate on Thursday (May 19) sent a House-passed bill to President Biden that gives families enrolled in WIC more flexibility in the formula they purchase. The House on Wednesday (May 18) also passed a $28 million emergency spending bill to support Food and Drug Administration (FDA) inspections of formula manufacturers, but the bill faces uncertain prospects in the Senate.
On Monday (May 16), the FDA also published guidance saying it will exercise enforcement discretion to enable the importation of certain infant formula from foreign manufacturers. The guidance expires after 180 days. In addition, FDA said it will allow Abbott Nutrition to resume manufacturing at its Sturgis, MI plant provided the company addresses key safety concerns.
HHS on track to extend PHE beyond July 15 deadline. The Department of Health and Human Services (HHS) appears poised to extend the public health emergency (PHE) for an additional 90 days beyond the current July 15 expiration date. There has been a lot of speculation on when HHS will allow the PHE and related waivers to lapse. HHS has committed to giving states at least 60 days’ notice before allowing the PHE to expire, which meant HHS would have needed to issue a statement this week if it did not plan to renew the current PHE beyond the July 15 expiration date. This suggests the new expiration deadline would be kicked out to mid-October, with a 60-day warning occurring sometime in August.
Senate HELP Committee unveils user fee agreement. On Tuesday (May 17), the Senate Health, Education, Labor and Pensions (HELP) Committee unveiled draft legislation that would reauthorize the FDA’s drug and medical device user fee programs. Among other things, the committee’s bill, titled the FDA Safety and Landmark Advancements (FDASLA) Act, would give FDA more authority to regulate cosmetics, dietary supplements, and lab-developed tests, including in-vitro tests. The package was unveiled the day before the House Energy & Commerce Committee approved its version of the bill. Congress aims to send a final package to President Biden by August. Click here for a section-by-section breakdown of the draft and here for the full legislative text.
FDA authorizes Pfizer COVID booster for children 5-11. On Tuesday (May 17), the FDA authorized a single booster shot of Pfizer-BioNTech vaccine for children ages 5 to 11 who completed the full series of Pfizer-BioNTech at least five months before. On Thursday (May 19), the Centers for Medicare and Medicaid Services (CMS) also recommended the booster shot for children ages 5 to 11.
CMS updates Medicare website. On Wednesday (May 18), CMS updated its Medicare.gov website to include new user-friendly features, including additional pricing information on Medicare Supplement Insurance Policies and prioritizing information on the homepage.
House Energy & Commerce Committee markup of bipartisan user fee, mental health and research bills. On Wednesday (May 18), the House Energy & Commerce Committee advanced six bipartisan health care bills to the full House. Committee Chair Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA) expressed their support for the bills and their commitment to passing legislation to reauthorize the FDA user fee agreements, the Food and Drug Amendments of 2022 (H.R. 7667), before the current user fee agreements expire on Sept. 30. During the markup, there was a lot of debate over two amendments to the Restoring Hope for Mental Health and Well-Being Act of 2022: the Mainstreaming Addiction Treatment (MAT) Act and the Medication Access and Training Expansion (MATE) Act, with some Republican members voicing opposition to the amendments. Meanwhile, Ranking Member Rodgers said an amendment to the Advanced Research Project Agency-Health Act, or the ARPA-H Act, (H.R. 5585) will “provide guardrails for the agency to be a success” and “put ARPA-H on the right path with a targeted mission, increased accountability and transparency, and a laser focus on promoting American innovators.”
House Education & Labor Committee markup of mental health, substance use disorder, school investments, and wage protection bills. On Wednesday (May 18), the House Education & Labor Committee advanced five bills to the full House, including two mental health and one substance use disorder prevention bill. The committee advanced the bipartisan Enhancing Mental Health and Suicide Prevention Through Campus Planning Act (H.R. 5407), as amended, to incentivize colleges and universities to develop and implement mental health and suicide prevention programs; the Mental Health Matters Act (H.R. 7780), as amended, which would ensure employer-sponsored health plans offer mental health and substance use disorder services, improve trauma-informed services in schools, and recruit school-based mental health counselors; and the Campus Prevention and Recovery Services for Students Act of 2022 (H.R. 6493), which would help institutions develop evidence-based prevention and recovery programs for alcohol and substance use disorder.
The House Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee held a hearing on “FY2023 Budget Request for the Food and Drug Administration.” On Thursday (May 19), the House Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee held a hearing to discuss the FDA’s fiscal year 2023 budget request. During the hearing both Democrat and Republican members discussed the United States’ infant formula shortage and called for structural and leadership changes at FDA’s food center.
The Senate (Special Committee on) Aging held a hearing on “Mental Health Care for Older Adults: Raising Awareness, Addressing Stigma, and Providing Support.” On Thursday (May 19), the Senate Committee on Aging heard testimony from witnesses on the mental health crisis facing U.S. seniors. During the hearing, both Democratic and Republican members discussed legislation to improve mental health care through Medicare and Medicaid, as well as evidence-based programs to support seniors and address loneliness.
Reports, Studies, and Journals
Congressional Budget Office. Budgetary Effects of a Policy That Would Lower the Age of Eligibility for Medicare to 60. The report projected that proposals to lower the Medicare eligibility age to 60 would reduce the uninsured rate for individuals ages 60 to 64 from 8% to 4% and increase the budget deficit by $155 billion over a five-year period. In addition, the report found about 7.3 million would be added to the Medicare program and 3.2 million fewer people would have employer-sponsored insurance.
RAND: Prices Paid to Hospitals by Private Health Plans. The report found employers and private insurance plans in 2020 paid hospitals 224% of what Medicare paid across all hospital inpatient and outpatient services in 2020. In addition, the report found no significant correlation between prices paid and a hospital’s share of Medicare and Medicaid patients.
The Lancet: Identifying who has long COVID in the USA: a machine learning approach using N3C data. For the study, researchers backed by the National Institutes of Health’s Researching COVID to Enhance Recovery initiative were able to use machine learning models to predict which COVID-19 patients would have long-term symptoms. The authors say the findings could help improve clinical research on long COVID.