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.


COVID-19 Origin Act Signed Into Law

President Joe Biden signed the COVID-19 Origin Act (S. 619) into law last week. The legislation would require Director of National Intelligence Avril Haines to declassify information about the origins of the coronavirus pandemic within 90 days. The administration can redact details to protect its sources and methods of obtaining information. The bill passed both chambers of Congress unanimously, following a recent report from the Department of Energy which concluded with ‘low confidence’ that COVID-19 most likely originated from a lab leak in China. Director of the Federal Bureau of Investigation (FBI) Christopher Wray has separately acknowledged the FBI’s determination that the pandemic had most likely come from a laboratory incident in Wuhan. New data was released last week, however, that provides inconclusive evidence linking COVID-19 to the DNA of racoon dogs being illegally sold at a wet seafood market in Wuhan. While the U.S. intelligence community remains split about the pandemic’s origins being animal transmitted or the result of a lab leak, the President has pledged to continue to review any links to the Wuhan Institute of Virology.

E&C Advances Five Health Bills

The House Energy and Commerce Committee advanced five pieces of health- related legislation last week.

  • The Protecting Health Care for All Patients Act (H.R. 485) would prohibit the use of quality-adjusted life years (QALYs) in federal and state programs. The bill was advanced 27-20 along party lines, with Ranking Member Frank Pallone (D-N.J.) reiterating his concerns that the bill’s prohibition on the use of QALYs to evaluate the cost- effectiveness of drugs and treatments could be used to delay or disrupt the implementation of the Inflation Reduction Act’s Medicare drug price negotiation provisions. Supporters of the bill argue that measures such as QALYs discriminate against seniors and people with disabilities.
  • The Block, Report, and Suspend Suspicious Shipments Act (H.R. 501) would require drug manufacturers and distributors to report and block suspicious orders of controlled substances. The bill was advanced unanimously after the adoption of an amendment specifying that the legislation does not intend to inhibit access to opioid use disorder treatment.
  • The 9-8-8 Lifeline Cybersecurity Responsibility Act (H.R. 498) would require the U.S. Department of Health and Human Services’ (HHS) to undertake efforts to protect the 9-8-8 Suicide & Crisis Lifeline from cybersecurity threats. It was also advanced by the committee unanimously.
  • The HALT Fentanyl Act (H.R. 467) would permanently place fentanyl-related substances into Schedule I of the Controlled Substances Act. Reps. Angie Craig (D-Minn.) and Kim Schrier (D-Wash.) joined panel Republicans in support of the legislation.
  • The Securing the Border for Public Health Act (H.R. 801) would expand HHS’ Title 42 authority to allow the HHS secretary to suspend persons and imports related to certain controlled substances from certain countries into the U.S. The bill was advanced in a party line vote.

Senate Commerce Committee Marks Up PBM Transparency Bill

The Senate Committee on Commerce, Science, and Transportation advanced bipartisan legislation (S. 127) last week that would prohibit pharmacy benefit managers (PBMs) from arbitrarily, unfairly, or deceptively clawing back payments made to pharmacies, or arbitrarily, unfairly, or deceptively increasing fees or lowering reimbursements to offset reimbursement changes in federally-funded health plans. The Pharmacy Benefit Manager Transparency Act of 2023 would also require PBMs to report to the Federal Trade Commission (FTC) revenue stemming from pharmacy fees and spread pricing. The bill, sponsored by Chair Maria Cantwell (D-Wash.) and Sen. Chuck Grassley (R-Iowa), was agreed to in an 18-9 vote, with some Republicans opposing the bill due to concerns about the looming 3-0 Democratic to Republican commissioner composition of the FTC. Proponents of the bill hope it will help to address both consolidation in the PBM industry and high drug prices.

HSGAC Chairman Peters Releases Report on Drug Shortages

Senate Committee on Homeland Security and Governmental Affairs Chairman Gary Peters (D-Mich.) has released a report on drug shortages which argues that neither U.S. regulators nor industry have enough information to predict which treatments will be in short supply and prevent future shortages. The nation is currently dealing with shortages of at least 120 drugs, with 15 critical drugs having experienced shortages for over a decade. The report blames low profit margins for old generics, manufacturing quality issues, and increased demand for persistent shortages. Peters previewed plans to introduce legislation based on the findings of his report during a hearing about drug shortages last week. The administration’s fiscal year 2024 budget request also made recommendations to improve transparency around drug shortages and require companies to extend drug expiration dates when safety permits.

GOP Health Leaders Inquire About MA Proposed Rule

Republican leadership of the House Energy and Commerce and Ways and Means committees sent a letter to the administration last week requesting more details about the changes to the Medicare Advantage (MA) program recently proposed by the Centers for Medicare and Medicaid Services (CMS). The letter states that House Republicans “remain committed to protecting and strengthening Medicare” and that they seek to better understand the impact of the Calendar Year 2024 Advance Notice for the MA Program on patients. CMS’ proposed regulation would make changes to the MA risk adjustment model.

House Panels to Investigate CMS Data Breach

Republican leadership of the House Oversight and Accountability and Energy and Commerce committees have announced an investigation into the Centers for Medicare and Medicaid Services’ (CMS) handling of an October 2022 data breach. Last year’s ransomware attack, which involved a third-party government subcontractor, impacted the personal data of more than 250,000 Medicare beneficiaries. The lawmakers criticize the agency for taking two months to characterize the hack as a major incident and to inform Congress of the event. During this time, the hackers had access to Medicare beneficiaries’ identifiable information, including names, contact information, Social Security numbers, bank account and routing numbers, Medicare enrollment details, and more. CMS has indicated that it plans to reply directly to the lawmakers’ inquiry, but also referenced a December press release on its response to the breach.

Tri-Caucus Urges Guardrails for Medicaid Redeterminations

The Congressional Tri-Caucus – comprised of the Congressional Hispanic Caucus, the Congressional Asian-Pacific American Caucus, and the Congressional Black Caucus – has sent a letter to the U.S. Department of Health and Human Services (HHS) urging Secretary Xavier Becerra to regulate and implement guardrails for states to follow to prevent individuals from losing Medicaid coverage for procedural reasons. Effective April 1, the fiscal year 2023 omnibus appropriations bill removed the federal continuous coverage requirement for state Medicaid programs that was instituted in response to the coronavirus pandemic, permitting states to begin eligibility redeterminations. The lawmakers ask HHS to set a high bar to prevent eligible beneficiaries from losing coverage, arguing that “such clarity will give states and territories strong new incentives for improving their policies to better protect eligible families.” The letter suggests ensuring states have sufficient staffing to process renewals, requiring state agencies to conduct electronic renewals to the maximum extent possible, and halting procedural dis-enrollments in states that do not follow the department’s unwinding guidance.

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