Summary
Congress is in session this week finalizing details to an end of the year package before the current Continuing Resolution expires on Friday at midnight. The Senate will also be voting on the National Defense Authorization Act on Wednesday.
Text of the end of the year package has not yet been released as leaders are still ironing out details on provisions such as economic assistance to farmers as part of a one-year extension to the farm bill. We do know that the CR will likely extend into March, and the package will also include tens of billions of dollars in disaster relief for areas in the southeast hit hard by hurricanes this fall. Timing is critical, and agreements will have to be reached very soon to move the measure through both the House and the Senate before midnight on Friday.
The health care part of the overall package, which has been in flux for the past two weeks, started to take shape over the weekend, though the situation remains fluid. The agreement is said to include a two-year extension for expiring telehealth provisions; telehealth coverage under high deductible health plans for one year; two years of funding for funding for community health centers, the public health service and HRSA’s Teaching Health Center GME program; a one year delay for scheduled cuts to disproportionate share hospitals (DSH) that serve communities most vulnerable members; and a 2.5% pay boost for the Medicare physician payment fee schedule. It is also said to include a two-year reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) and a five-year reauthorization for the SUPPORT Act for Programs for Opioid Response. Pharmacy benefit manager and patent reforms, reduced funding in the Medicare Improvement Fund (MIF), and other cost saving measures such as requiring the use of a National Provider Identifier (NPI) by Off-Campus Hospital Outpatient Clinics are being used to offset the cost of the package.
Impact Health Policy Partners will be putting out a comprehensive memo on the health care package with more details when the text becomes available.
119th Congress: Last week the Republican House Steering Committee met to finalize the Committee leadership positions for the next Congress. Representative Brett Guthrie (R-KY) was named the new Chair of the House Energy & Commerce Committee and Rep. Tim Walberg (R-MI) was named the new Chair of the House Education and the Workforce Committee. New members of the Ways and Means Committee include Rep. Aaron Bean (R-FL); Rep. Max Miller (R-OH); Rep. Nathaniel Moran (R-TX); and Rep. Rudy Yakym (R-IN). New Republican members of the Energy and Commerce Committee include Rep. Cliff Bentz (R-OR); Rep. Erin Houchin (R-IN); Rep. Russell Fry (R-SC); Rep. Laurel Lee (R-FL); Rep. Craig Goldman (R-TX); Rep. Rep. Tom Kean (R-NJ); Rep. Julie Fedorchak (R-ND); Rep. Nick Langworthy (R-NY); Rep. Gabe Evans (R-CO); and, Rep. Mike Rulli (R-OH). The Democratic Steering Committee should be making their leadership and committee roster announcements as soon as this week.
Regulatory Update
The Office of Management and Budget (OMB) completed review two FDA final rules:
- Nonprescription Drug Product – The final rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. The final rule would establish requirements for a drug product that could be marketed as a nonprescription drug product with an additional condition for nonprescription use (ACNU) that an applicant must implement to ensure appropriate self-selection, appropriate actual use, or both by consumers.
- Nutrition – The final rule would update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and federal dietary guidelines. The rule would revise the requirements for when the claim “healthy” can be voluntarily used in the labeling of human food products to indicate that a food, because of its nutrient content, may be useful in achieving a total diet that conforms to current dietary recommendations and helps consumers maintain healthy dietary practices.
OMB is also reviewing the following:
- Notice of Benefit and Payment Parameters for 2026 – The final rule sets forth 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.
- 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).
- Cybersecurity – The proposed rule would make modifications to the Security Standards for the Protection of Electronic Protected Health Information (the Security Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). These modifications will improve cybersecurity in the health care sector by strengthening requirements for HIPAA regulated entities to safeguard electronic protected health information to prevent, detect, contain, mitigate, and recover from cybersecurity threats.