WHG - Weekly, September 23, 2024

Summary

The House and Senate are both in session and working to pass a Continuing Resolution (CR) to keep the government in operation past September 30.  Last week after the House Republican leadership tried and failed to pass a six-month CR along with Trump-backed legislation that would require proof of citizenship to vote, Speaker Mike Johnson (R-LA) began to negotiate with the Democrats and the Senate leadership on a CR that would actually pass.  Over the weekend, leadership on both sides of the Capitol agreed on the 49-page CR (full text/ section by section) that will extend funding for government operations until December 20^th of this year.

In addition to keeping all government agencies funded at current levels, the CR also includes some health care provisions including extending the availability of funding to implement the surprise billing law enacted in late 2020 and delaying pending clinical laboratory payment cuts under Medicare.  The bill also provides $231 million in additional funding for the Secret Service and funding for the presidential inauguration and presidential transition period.  There is no disaster aid included or funding for Baltimore’s Francis Scott Key Bridge, punting both of those funding decisions until after the election.

The House Rules Committee is expected to take up the bill this evening.  If the ultra-conservative faction of the Rules Committee prevents passage, Speaker Johnson will be forced to bring the bill to the floor under suspension. Either way, he will need to depend on Democratic votes to pass the measure.  The Senate will take up the bill as soon as it passes the House, and barring any procedural protests, will pass the CR by the end of the week allowing both chambers to recess until after the November elections.

The House is also scheduled to take up a number of bills under suspension this week including:

• H.R. 6829 – HEARTS Act of 2024, to support the creation and dissemination of cardiomyopathy education, awareness, and risk assessment materials and resources to identify more at-risk families, to authorize research and surveillance activities relating to cardiomyopathy.
• H.R. 3884– Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023 to reauthorize the program providing for sickle cell disease and other heritable blood disorders research, surveillance, prevention, and treatment.
• H.R. 2706– Charlotte Woodward Organ Transplant Discrimination Prevention Act, to prohibit discrimination on the basis of mental or physical disability in cases of organ transplants.
• S.133– NAPA Reauthorization Act to extend the National Alzheimer’s Project.
• S.134– Alzheimer’s Accountability and Investment Act to require an annual budget estimate for the initiatives of the National Institutes of Health pursuant to reports and recommendations made under the National Alzheimer’s Project Act.
• H.R. 7189– Congenital Heart Futures Reauthorization Act of 2024, to reauthorize a national congenital heart disease research, surveillance, and awareness program.
• H.R. 5526– Seniors’ Access to Critical Medications Act of 2024, to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program.
• H.R. 3433– Give Kids a Chance Act of 2023, authorizes certain targeted clinical trials involving combinations of drugs to treat pediatric cancer.

Hearings and Markups: There are several hearings and markups scheduled for this week, including:

Senate Finance Committee: On Tuesday, the Senate Finance Committee will hold a hearing to examine women’s health care, featuring testimony from obstetricians and gynecologists.

Senate HELP Committee:

• On Tuesday the Senate Committee on Health, Education, Labor, and Pensions will hold a hearing to examine Novo Nordisk’s high prices for Ozempic and Wegovy for patients with diabetes and obesity.
• On Thursday the Senate Committee on Health, Education, Labor, and Pensions will hold a markup to consider bills that would require the Department of Health and Human Services (HHS) to submit a strategic plan for the Human Foods Program of the Food and Drug Administration (FDA), reauthorize the FDA Rare Pediatric Disease Priority Review Voucher Program, eliminate red tape for biosimilars, require reporting on infant formula contamination, and authorize a grant program at HHS to award grants to accredited schools of medicine or osteopathic medicine for the purpose of increasing enrollment of medical students at eligible institutions.

House Oversight Committee: On Thursday the House Oversight and Accountability Subcommittee on Health Care and Financial Services will hold a hearing titled “Meddling with Medicare: The Biden-Harris Cover-Up.

Regulatory Update

The Office of Management and Budget (OMB) completed review the following rule:

• Fraud – The final rule would modify the Medicare Shared Savings Program (Shared Savings Program) regulations to address the impact of significant anomalous billing patterns on performance year (PY) 2023 Accountable Care Organization (ACO) financial reconciliation (no date).

OMB is also reviewing the following rules:

Medicare

• Hospital Payment – The interim final rule would make changes to the Medicare hospital inpatient and long-term care hospital prospective payment system for fiscal year (FY) 2025.
• Medicare Advantage – The proposed rule would make policy and technical changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE for contract year 2026 (September 2024).

Private Insurance

• ACA Marketplace – The proposed rule would set payment parameters and provisions related to the risk adjustment programs; cost-sharing parameters; and user fees for issuers offering plans on Federally-facilitated Exchanges and State-based Exchanges using the Federal platform.  It would also provide additional standards for several other ACA programs (September 2024).
• Preventive Services – The proposed rule is titled, “Enhancing Coverage of Preventive Services under the Affordable Care Act.” It was not included in the latest Unified Agenda.

Other Topics

• Healthcare System Resiliency and Modernization – The proposed rule would revise and update national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers (was set for December 2023).
• Retail Pharmacy Standards – The final rule would require pharmacies and vendors to modify the currently adopted National Council for Prescription Drug Programs (NCPDP) standards to the Telecommunications Standard Implementation Guide Version F6 (F6); Batch Standard Implementation Guide version 15; and Batch Standard Subrogation Implementation Guide version 10 (was set for February 2024).
• Organ Transplants – The final rule would establish a new mandatory Medicare payment model, the Increasing Organ Transplant Access Model (IOTA Model), that would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures.