This Week in Washington: Congress averts government shutdown; President issues executive order concerning foreign exploitation of health data; Sen. McConnell announces he is stepping down as leader at the end of the term; State of the Union on Thursday.
House
Congress Passes CR and Averts Government Shutdown
On Feb. 29, the House and Senate passed a continuing resolution (CR), averting a partial government shutdown. The CR pushes back the deadlines of the Agriculture-FDA, Commerce-Justice-Science, Energy-Water, Interior-Environment, Military Construction-VA and Transportation-HUD appropriations bills to March 8.
The CR also pushes back the deadlines of the Defense, Financial Services, Legislative Branch, Homeland Security, Labor-HHS-Ed and State-Foreign Operations appropriations bills to March 22. It remains unclear what policy riders, if any, the Agriculture-FDA and HHS funding bills will contain.
On March 3, the legislative text of six funding bills was posted. Among them was funding for the FDA. The language calls for the FDA to reallocate at least $50 million to prioritize cosmetics oversight, alternatives to animal testing and mitigation of product shortages. It is expected that this legislation will be acted on by the House this week.
Skinny Health Package Announced
On March 3, the text of a healthcare spending package was released. It includes a 1.68 percent payment increase to the Medicare Fee Physician Schedule, partially mitigating a 3.4 percent cut that went into effect January 1. The package also includes $4.27 billion for community health centers (CHCs), less than the House passed in the Lower Costs, More Transparency Act but higher than the roughly 4 billion dollar cost of current continuing funding levels. The bill funds CHCs from October 2023 to the end of calendar year 2024. It also makes permanent a state plan amendment option to circumvent the IMD exclusion and permanently requires state Medicaid plans to cover state Medicaid assisted treatment.
Notably, this would establish behavioral health clinic services as an optional Medicaid benefit and requires HHS to issue guidance on how states can improve integrating behavioral health with primary care. In addition, there is increased funding for the Special Diabetes Program and the Special Diabetes Program for Native Americans and an increase in funding for graduate teaching medical programs. Left behind are several health priorities including hospital site-neutral policies, pharmacy benefit manager reforms and full reauthorization of the Pandemic and All Hazards Preparedness Act. However, some of these policies could be addressed later this year.
House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Multiple Rare Disease Proposals
On Feb. 29, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals concerning patient access to rare disease treatments and care. The proposals discussed include:
H.R. 1092, Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act: Modifies the new drug approval process by requiring the Food and Drug Administration (FDA) to utilize patient-experience data as part of the benefit-risk assessment framework.
H.R. 3433, Give Kids a Chance Act: Authorizes the FDA to require pediatric cancer trials for new drugs that are used in combination with active ingredients that meet the standard of care for targeting pediatric cancer or have been approved to treat adult cancer and are directed at molecular targets.
H.R. 4758, Accelerating Kids Access to Care Act: Permits enrollment under Medicaid for eligible out-of-state providers by enabling providers to enroll in state Medicaid programs without additional screening requirements.
H.R. 5539, Optimizing Research Progress Hope and New (ORPHAN) Cures Act: Expands and clarifies the exclusion for orphan drugs under the Drug Price Negotiation Program, allowing drugs that treat multiple rare diseases to maintain their orphan drug status and remain exempt from Medicare drug negotiations.
H.R. 5547, Maintaining Investments in New Innovation (MINI) Act: Modifies the criteria for certain single source drugs to qualify for the Drug Price Negotiation Program after being approved for 11 years instead of 7 years.
H.R. 5663, ALS Better Care Act: Expands Medicare coverage to include relevant services for people diagnosed with amyotrophic lateral sclerosis and establishes a supplemental facility-based payment system that would cover outpatient services administered by a qualified provider.
H.R. 6020, Honor Our Living Donors Act: Prevents an organ recipient’s income from being considered when providing reimbursement for qualifying expenses incurred by a living organ donor during the donation process.
H.R. 6094, Providing Realistic Opportunity to Equal and Comparable Treatment (PROTECT) for Rare Act: Expands the definition of medically accepted indications in Medicare Part D and Medicaid to include treatments for rare diseases that are supported in peer-reviewed literature and clinical guidelines and do not otherwise have unfavorable reviews. The legislation also expedites coverage reviews for such treatments by private health insurers.
H.R. 6465, Preserving Life-saving Access to Specialty Medicines in America (PLASMA) Act: Modifies how plasma derived products are treated in relation to the Part D cost-sharing structure by phasing-in the increase in manufacturer rebates over five years under the existing pathway for small biotechnology manufacturers.
H.R. 6664, Innovation in Pediatric Drugs Act: Removes the existing exemption for orphan drugs to be studied in children after approval and authorizes the FDA to penalize companies that have not completed required pediatric studies on time. This legislation also increases funding for the National Institutes of Health Best Pharmaceuticals for Children’s Act program from $25 to $50 million through fiscal year (FY) 2027.
H.R. 6705, Effective Screening and Testing for Tuberculosis Act: Requires the Secretary of the Department of Health and Human Services (HHS) to treat certain tests for tuberculosis as breakthrough devices eligible for expedited development and priority review, and requires certain donor screening or testing to screen or test for active and latent tuberculosis.
H.R. 7188, Shandra Eisenga Human Cell and Tissue Product Safety Act: Requires the Secretary of HHS to conduct a national, evidence-based education campaign to increase public and healthcare provider awareness of the potential risks and benefits of human cell and tissue products transplants. This legislation also establishes civil monetary penalties for any person who violates human cell and tissue product requirements and requires the Secretary to submit a report on how the safety of such products could be improved.
H.R. 7248, FDA Modernization Act 3.0: Establishes a process for the qualification of nonclinical testing methods to replace the use of animals in nonclinical research.
H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act: Clarifies the FDA’s interpretation of limiting orphan drug exclusivity to the approved indication rather than the potentially broader designation.
H.R. 7384, Creating Hope Reauthorization Act of 2024: Extends the FDA priority review voucher program from FY 2024 through FY 2028 to incentivize the development of drugs for rare pediatric diseases.
H.R. 7436, Antimicrobial Resistance Research Assessment Act: Requires the Government Accountability Office to report on the efforts of the federal government to address antimicrobial resistance, including the roles of each federal program in these efforts and recommendations to improve coordination.
H.R. , Patient Access Act: Prevents antikickback penalties from being applied to certain travel and lodging arrangements made between a drug manufacturer and an individual who is prescribed such a drug.
H.R. , Sickle Cell Disease Comprehensive Care Act: Allows state Medicaid programs to establish health homes for eligible beneficiaries with sickle cell disease.
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House to Vote on Healthcare Bills Under Suspension of the Rules
This week, the House is expected to vote on several healthcare bills under suspension of the rules, which prohibits amendments from being introduced, limits floor debate and requires a two-thirds majority vote for legislation to pass. The bills include:
H.R. 498, 9-8-8 Lifeline Cybersecurity Responsibility Act of 2023: Strengthens cybersecurity protections for the 9-8-8 suicide prevention hotline.
H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023: Reauthorizes through fiscal year (FY) 2028, federal support for state-based efforts aimed at reducing disparities in maternal health outcomes and improving maternal mortality review committees.
H.R. 3821, Firefighter Cancer Registry Reauthorization Act of 2023: Reauthorizes the National Firefighter Registry for Cancer through FY 2028.
H.R. 3836, Medicaid Primary Care Improvement Act: Clarifies that Medicaid programs are authorized to provide primary care services through direct primary care arrangements.
H.R. 3843, Action for Dental Health Act of 2023: Reauthorizes state grants that support dental health workforce activities in areas that face dental health provider shortages, through FY 2028.
H.R. 3391, Gabriella Miller Kids First Research Act 2.0: Reauthorizes the National Institutes of Health pediatric research initiative through FY 2028 and requires the Department of Health and Human Services to report to Congress about research funded through the initiative.
H.R. 4510, NTIA Reauthorization Act: Reauthorizes the National Telecommunications and Information Administration through FY 2025 and supports the expansion of broadband, which is used extensively in telehealth.
S. 206, END FENTANYL Act: Requires the Commissioner of U.S. Customs and Border Protection to update and review policies and manuals used during inspections at ports of entry to improve the discovery of drug and human smuggling.
Senate
Senate Minority Leader Announces He is Stepping Down as Leader at End of Term
On Feb. 28, Senate Minority Leader Mitch McConnell (R-KY) announced that he will be stepping down from his role as leader of the Senate Republican Conference at the end of this term. McConnell has been leading Senate republicans since 2007.
Sen. Grassley Requests Floor Vote on PBM Bills
Sen. Grassley (R-IA) recently urged Senate Majority Leader Chuck Schumer (D-NY) to schedule floor votes on a series of pharmacy benefit manager (PBM) bills that Senate committees favorably reported last year, after he received an update from the Federal Trade Commission (FTC) considering its ongoing investigation of PBM business practices.
The FTC reported that it has been unable to conclude its ongoing investigation because six major PBMs have failed to submit documents and data concerning their use of drug manufacturer rebates and fees, creation of drug formularies and pharmacy reimbursements. The PBMs include CVS Caremark, Express Scripts, OptumRx, Humana Pharmacy Solutions, Prime Therapeutics and MedImpact Healthcare Systems.
Sen. Duckworth’s Attempt to Seek Unanimous Consent on IVF Bill Fails
On Feb. 28, in response to the Alabama Supreme Court’s ruling concerning in vitro fertilization (IVF), Sen. Duckworth (D-IL) sought to pass by unanimous consent the Access to Family Building Act, a bill she introduced in 2022 which would establish a federal protection for IVF access. However, the bill was blocked by Sen. Hyde-Smith (R-MS).
Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.