May 9, 2022
This Week in Health Policy for May 9
This Week (May 9-13)
Senate Health, Education, Labor and Pensions Committee will hold a hearing on "the Nomination of Kalpana Kotagal to be a Member of the Equal Employment Opportunity Commission."
Senate Appropriations Interior, Environment, and Related Agencies Subcommittee will hold a hearing on "FY2023 budget for the Indian Health Service."
The House Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee will hold a hearing on "FY2023 budget for the Indian Health Service."
The House Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee will hold a hearing on "Healthy Aging: Maximizing the Independence, Well-being, and Health of Older Adults."
The House Veterans' Affairs Health Subcommittee will hold a hearing on "Innovative Care Delivery at VA: Partnering to Improve Infrastructure and Operational Efficiency."
Last Week (May 2-6)
Health Care Highlights
House Energy & Commerce Committee Unveils FDA User Fee Package. On Wednesday (May 4), lawmakers on the House Emergency and Commerce Committee unveiled bipartisan legislation that would reauthorize FDA's drug and medical device user fee programs. Among other things, the bill would codify FDA's definition of orphan drug exclusivity, which limits the designation to approved indications as opposed to entire diseases or conditions; allow FDA to approve generics even if their proposed labelling differs from their brand-name counterparts; and enable FDA to remove accelerated approval drugs from the market if they fail to show a clinical benefit or conduct required post-market studies through an expedited process. The bill would allow drugmakers to support post-market studies with real-world evidence and calls on FDA to identify surrogate endpoints and trial designs for early-stage development. The House Energy & Commerce Committee's health subcommittee is expected to mark up the package next week, with lawmakers aiming to have a final package to President Biden by August ahead of the Sept. 30 deadline, when the current user fee agreements expire.
House Republicans outline drug pricing priorities. Last Friday (April 29), the GOP Healthy Future Task Force, a House Republican policy task force, outlined their plans to lower drug costs if they retake Congress after the midterms. The plan centers around the Lower Costs, More Cures Act (HR 19), which includes provisions to ensure site neutrality for physician-administered drugs in physician offices and HOPDs, ban so-called "pay-for-delay" deals among drug companies, expand the use of FDA's accelerated approval pathway, cap out-of-pocket drug costs for seniors, and more. However, the bill does not include larger reforms to rein in federal spending to let Medicare negotiate drug prices, tie drug prices to those paid in foreign nations, or impose inflation rebates on drugmakers.
White House announces conference on hunger, nutrition and health. On Wednesday (May 4), the White House announced they will host a Conference on Hunger, Nutrition and Health this September for the first time in over 50 years. According to a White House statement, "The Conference, and the preparatory work leading up to it, will accelerate progress and drive significant change to end hunger, improve nutrition and physical activity, reduce diet-related disease, and close the disparities around them." The Biden-Harris Administration has set a goal of ending hunger and increasing healthy eating and physical activity in the U.S. by 2030 "so that fewer Americans experience diet-related diseases, such as diabetes, obesity, and hypertension." The Conference will aim to galvanize action by anti-hunger and nutrition advocates; food companies; the health care community; state and local governments; people with lived experiences; and all Americans, and it will launch a national plan outlining how to achieve the administration's goal. The White House will host listening sessions leading up to the conference.
Leaked Supreme Court document heightens focus on abortion care. On Monday (May 2), Politico reported on a leaked draft majority opinion from Supreme Court Justice Samuel Alito in a case, Planned Parenthood v. Casey, challenging Mississippi's law banning abortion after 15 weeks gestation that would strike down Roe v. Wade and give states the authority to restrict or ban abortion. Supreme Court Chief Justice John Roberts confirmed the authenticity of the draft opinion but said it does not represent the court's final ruling. However, the potential ruling prompted President Biden to issue a statement, saying the Gender Policy Council and White House Counsel's Office are preparing "options for an Administration response" regarding the upcoming Supreme Court ruling. Outgoing White House press secretary Jen Psaki said the Biden administration is considering new grants to help expand access to emergency contraception. In addition, telehealth providers are preparing for an increase in virtual visits for medication abortion pills in states in which the service is legal. Democrats in Congress also have introduced legislation to codify Roe v. Wade into law, though they do not have the 60 votes needed to pass such legislation in the Senate.
The Senate Commerce Subcommittee hearing on "Ensuring Fairness and Transparency in the Market for Prescription Drugs." On Thursday (May 05), the Senate Commerce, Science, & Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security held a hearing entitled, "Ensuring Fairness and Transparency in the Market for Prescription Drugs." The hearing, which is one of several Subcommittee Chair Richard Blumenthal (D-CT) plans to hold on lowering consumers' prescription drug costs, focused on the role pharmacy benefit managers (PBMs) play in consumers' drug costs. Witnesses at Thursday's hearing included a representative from the Pharmaceutical Care Management Association (PCMA), which represents PBMs; an antitrust attorney and former Federal Trade Commission (FTC) policy director; and academics. During the hearing, committee leaders raised concerns about a lack of transparency regarding PBM practices, market consolidation and competition, and the impact on consumers.
Reports, Studies, and Journals
HHS Assistant Secretary for Planning and Evaluation: Health Coverage Changes Under the Affordable Care Act: End of 2021 Update. The report, which examines coverage changes during the COVID-19 pandemic, found the U.S. uninsured rate fell in 2021 and that enrollment in coverage related to the Affordable Care Act (exchange plans, Medicaid expansion, and the Basic Health Program) hit an all-time high in 2022.
Health Affairs: Medicare Beneficiaries In Disadvantaged Neighborhoods Increased Telemedicine Use During The COVID-19 Pandemic. The study, which is based on Medicare fee-for-service claims data, suggest that federal waivers expanding access to telemedicine increased access to telemedicine for all Medicare populations, including beneficiaries living in disadvantaged neighborhoods. However, the study showed telemedicine use declined with age.
JAMA: Association of SARS-CoV-2 Infection During Pregnancy With Maternal and Perinatal Outcomes. The study, which examined COVID-29 infection among pregnant women in Canada, found pregnant women were more likely to be hospitalized for COVID-19 and admitted to the intensive care unit when compared with the general population of reproductive-age females. In addition, they found COVID-19 infection increased the risk of pre-term birth among pregnant women.