POLICY BRIEFINGS

Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


THIS WEEK'S BRIEFING - APRIL 3, 2023

Congressional Spring Recess Begins


Congress will return to session on Monday, April 17. The House of Representatives is in a District Work Period through Sunday, April 16, 2023, but will convene for a pro forma session on Monday, April 3. During the recess, the Senate will convene on Mondays and Thursdays for pro forma sessions only, with no business being conducted.


President to Sign Legislation Ending COVID-19 National Emergency


President Joe Biden plans to sign into law legislation passed by the Senate last week (H.J.Res. 7) that would terminate the COVID-19 national emergency early, despite White House opposition to the measure. The bill – which passed the House of Representatives on February 1 and cleared the Senate in a 68-23 vote on Wednesday – would immediately end the national emergency upon being signed by the President. Both the COVID-19 public health emergency (PHE) declared in January 2020, and the national emergency declared in March 2020 are set to expire on May 11 under the wind-down plan announced by the administration in January. While May 11 remains the expiration date of the COVID-19 PHE, the resolution will impact federal healthcare programs. Blanket waivers issued by the U.S. Department of Health and Human Services - including certain requirements for Medicare provider enrollment, requirements for in-person meetings between providers and patients, and requirements for out-of-state Medicare and Medicaid providers to be licensed in the state where they are providing services – were issued under the national emergency declaration. Some additional flexibilities issued to states and territories for the administration of their Medicaid and CHIP programs, like those permitting the provision of services in alternative settings and those to ease provider enrollment in the programs, are also tied to the national emergency declaration. Although the administration “strongly opposes” H.J.Res. 7, it “will continue working with agencies to wind down the national emergency with as much notice as possible to Americans who could potentially be impacted,” a White House official stated to The Hill. More information on the emergency declarations can be found in Hart Health Strategies Inc.’s primer on Public Health Emergencies and Major Disaster Declarations.


Judge Strikes ACA’s Preventive Services, HIV Treatment Coverage Mandates


U.S. District Court Judge Reed O’Connor has struck down the Affordable Care Act’s (ACA) preventive services coverage requirement. The requirement mandates that insurers and employers cover more than 100 preventive health services, e.g., mammograms and colonoscopies, recommended by the U.S. Preventive Services Task Force (USPSTF) for free. The judge for the Northern District of Texas ruled that the USPSTF is unconstitutional because its members wield power that resembles legislative authority without being appointed by the President and confirmed by the Senate. He also invalidated the law’s coverage mandate for HIV pre-exposure prophylactic (PrEP) drugs on the grounds that it violates the religious freedom of a Christian-owned company. The Biden administration is expected to appeal the decision.


Medicare Trustees Recommend Congress Address Projected Shortfalls


On Friday, the Medicare Boards of Trustees released their annual report on the Federal Hospital Insurance (Medicare Part A) and Federal Supplementary Medical Insurance (Medicare Part B) Trust Funds. The Trustees have again determined that the Part A trust fund “is not adequately financed over the next 10 years.” The depletion date is now 2031, 3 years later than last year’s projection. Expenditures exceeded income in 2022 and deficits are projected beginning in 2025. The Part A trust fund has failed to meet the Trustees’ formal short-range financial adequacy test since 2003. The Part B trust fund draws from general revenue and therefore is expected to be adequately financed through beneficiary premiums and federal funds. Upon the release of the report, CMS Administrator Chiquita Brooks-LaSure stated that “Everyone in the Biden-Harris Administration is committed to protecting Medicare, and we look forward to working with Congress to strengthen this vital program serving over 65 million Americans.”


E&C GOP Leaders Contact FDA on Drug Shortages, Gain-of-Function Research


House Energy and Commerce Committee Republican leadership have sent a letter to the Biden administration requesting information related to drug shortages. The lawmakers assert that the Food and Drug Administration (FDA) may not effectively be using its existing authorities to prevent or reduce ongoing drug shortages and request details about the scarcity of drugs to treat asthma, cancer, tuberculosis, bacterial infection, and headaches, pain, and fever – specifically seeking information on shortages of albuterol, Pluvicto, cisplatin, fluorouracil, methotrexate, Bacillus Calmette- Guerin (BCG), amoxicillin, acetaminophen, and ibuprofen. They point out that the agency has not yet released any information on the reports required by the Coronavirus Aid, Relief, and Economic Security Act from industry on listed drugs manufactured, prepared, or processed for commercial distribution and where active pharmaceutical ingredients and finished dosage forms were made. The letter to FDA Commissioner Robert Califf was signed by Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.). The lawmakers request a response by April 13.

Rodgers, Guthrie, and Griffith also sent a separate letter to Commissioner Califf following up on prior questions posed to the agency about the FDA’s funding of gain-of-function research last week. While FDA staff have acknowledged that some agency research studies “involve virus manipulation, passaging of a virus, genetically modified animals, or making any mutations to a virus,” the latest letter requests additional details to put these studies in context and enable an assessment of the adequacy of FDA’s oversight of potential risks in such experiments. The lawmakers request a response to this letter by April 10.


Eshoo, Guthrie Call on FDA to Address Backlog of Cell and Gene Therapy Applications


House Energy and Commerce Health Subcommittee leadership Chairman Brett Guthrie (R-Ky.) and Ranking Member Anna Eshoo (D-Calif.) have sent a letter to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research Director Peter Marks expressing concerns about the increasing number of clinical holds on biologics license applications which delay a proposed clinical investigation or suspend an ongoing investigation for such products. They request details about the agency’s process for addressing these holds and “encourage the FDA to use its regulatory discretion where necessary to make these innovative products available to patients in need, particularly those with ultra-rare or fatal diseases or for whom there are limited or no treatment options. The full letter can be found here and requests a response no later than April 14.


Comer Requests Briefing on Regulation of Tobacco, Nicotine


House Oversight and Accountability Chairman James Comer (R-Ky.) has sent a letter to the Food and Drug Administration requesting information and a staff briefing on the Center for Tobacco Product’s (CTP) tobacco and nicotine regulatory programs. Comer references a recent evaluation by the Reagan-Udall Foundation, which found that CTP has not clearly detailed “the most basic elements” of such programs, resulting in “confusion, inefficiency, litigation, and suspicions of political interference.” The letter expresses concerns that the Center has allowed unsafe and unregulated products to proliferate on the market and requests a response from the agency no later than April 11.


Duckworth Urges FTC Intervention on Mifepristone Distribution


Sen. Tammy Duckworth (D-Ill.) is urging the Federal Trade Commission (FTC) to investigate AmerisourceBergen following reports that the company plans to limit the sale of mifepristone. AmerisourceBergen is the sole wholesale distributor of the brand-name version of the abortion medication. “The bottom line is that based on existing information, data and evidence, one cannot dismiss the possibility that AmerisourceBergen may be using broader political disagreements and active legal debates as pretextual cover and justification for engaging in anticompetitive, unfair, and deceptive practices that are primarily concerned with maximizing profit margins by reducing consumer choice and restricting trade with an entire industry of retail pharmacies,” Duckworth argues.



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