2024-14828: Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments

Summary

This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of, and proposing policies for, the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the diabetes payment structure and PHE flexibilities; expansion of colorectal cancer screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of the Affordable Care Act.

The agency’s own summary, as published.

What this changes

Amends 11 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 42 CFR 401 General Administrative Requirements
• 42 CFR 405 Federal Health Insurance for the Aged and Disabled
• 42 CFR 410 Supplementary Medical Insurance (SMI) Benefits
• 42 CFR 411 Exclusions from Medicare and Limitations on Medicare Payment
• 42 CFR 414 Payment for Part B Medical and Other Health Services
• 42 CFR 423 Voluntary Medicare Prescription Drug Benefit
• 42 CFR 424 Conditions for Medicare Payment
• 42 CFR 425 Medicare Shared Savings Program
• 42 CFR 427 Medicare Part B Drug Inflation Rebate Program
• 42 CFR 428 Medicare Part D Drug Inflation Rebate Program
• 42 CFR 491 Certification of Certain Health Facilities