Summary
Congress is back in session this week, pending member ability to travel to the Capitol amidst the snowstorm, and President Trump’s State of the Union Address is tomorrow night. While the speech is likely to focus on current issues such as the Supreme Court decision on tariffs, and Department of Homeland Security (DHS) funding, the President will also use the opportunity to highlight health care achievements to date, including H.R. 1, the Most Favored Nation agreements, and TrumpRx, and the need to continue to focus on affordability through his Great Healthcare Plan.
CDC and ACIP Update
Last week, current National Institutes of Health Director Jay Bhattacharya, was named the acting director of the Centers for Disease Control and Prevention (CDC), while the Trump Administration announces a new nominee to permanently lead the agency. This came ahead of the indefinite postponement of the February 25th meeting of the Advisory Committee on Immunization Practices (ACIP). The meeting was expected to discuss mRNA COVID-19 vaccines.
FDA Modernization
Also last week, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy released a report outlining potential legislative and regulatory reforms to modernize the Food and Drug Administration, with recommendations focused on eliminating red-tape and increasing predictability and integrating artificial intelligence (AI) in the review process to expedite approval. This week, the FDA is expected to release guidance on a new approval pathway for individualized drug and biologics therapies under the plausible mechanism framework, which will be impactful for treatments targeting rare and genetic diseases.
Regulatory Update
The Office of Management and Budget completed its review of the following:
- Immigration Status. A Department of Labor proposed rule titled, “Improving Wage Protections for H-1B and PERM Employment in the United States.”
OMB is also reviewing:
- Coverage and Payment:
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- Medicaid:
- State Directed Payments. A proposed rule titled, “Medicaid Managed Care-State Directed Payments.” The proposed rule appears intended to advance a presidential memorandum released on June 6, which directs HHS to “eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare, to the extent permitted by applicable law.”
- Medicaid Tax Waivers. A proposed rule titled, “Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes.”
- The FY 2027 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System proposed rule.
- Medicare Advantage. The Contract Year 2027 Policy and Technical Changes to Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan, and Programs of All-Inclusive Care for the Elderly Programs final rule.
- No Surprises Act. A final rule titled, “Independent Dispute Resolution Operations.” Thing long-awaited rule was proposed in November 2023 by the Biden Administration.
- Medicaid:
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- Prior Authorization. A proposed rule on interoperability standards and prior authorization for drugs.
- Oversight and Integrity
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- Fraud and Abuse. A proposed rule titled, “Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH).”
- Accrediting Organizations. A final rule titled, “Strengthening Oversight of Accrediting Organizations (AO), Burden Reduction, and Related Provisions.”
- Other Topics:
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- Health Technology. A final rule titled, “Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures.”
- An interim final rule titled, “Unaccompanied Children Program Foundational Rule; Update to Include Proof of Identity and Income Verification Standards.”
- Nutrition Assistance. A proposed rule titled, “Supplemental Nutrition Assistance Program: Reforming Categorical Eligibility.”
- Medication-Assisted Treatment. A final rule titled, “Implementation of the SUPPORT Act: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment.”