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

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 401, 405, 410, 411, 414, 423, 424, 425, 427, 428, and 491</CFR> <DEPDOC>[CMS-1807-F and CMS-4201-F5]</DEPDOC> <RIN>RIN 0938-AV33 and 0938-AU96</RIN> <SUBJECT>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</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This final 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 establishment of new 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 and Medicare Parts C and D Overpayment Provisions of the Affordable Care Act. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> These regulations are effective on January 1, 2025. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for any issues not identified below. Please indicate the specific issue in the subject line of the email. Michael Soracoe, (410) 786-6312, Morgan Kitzmiller, (410) 786-1623, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to practice expense, work RVUs, conversion factor, and PFS specialty-specific impacts. Hannah Ahn, (814) 769-0143, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to potentially misvalued services under the PFS. Mikayla Murphy, (667) 414-0093, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to direct supervision using two-way audio/video communication technology, telehealth, and other services involving communications technology. Tamika Brock, (312) 886-7904, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to teaching physician billing for services involving residents in teaching settings. Sarah Leipnik, (410) 786-3933, Mikayla Murphy, (667) 414-0093, Regina Walker-Wren, (410) 786-9160, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to payment for caregiver training services and addressing health-related social needs (community health integration, principal illness navigation, and social determinants of health risk assessment). Erick Carrera, (410) 786-8949, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to office/outpatient evaluation and management visit inherent complexity add-on. Sarah Irie, (410) 786-1348, Emily Parris (667) 414-0418, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to payment for advanced primary care management service. Sarah Leipnik, (410) 786-3933, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to global surgery payment accuracy. Pamela West, (410) 786-2302, for issues related to supervision of outpatient therapy services in private practices, certification of therapy plans of care, and KX modifier threshold. Lindsey Baldwin, (410) 786-1694, Regina Walker-Wren, (410) 786-9160, Erick Carrera, (410) 786-8949, Mikayla Murphy, (667) 414-0093, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to advancing access to behavioral health services. Michelle Cruse, (443) 478-6390, Erick Carrera, (410) 786-8949, Zehra Hussain, (214) 767-4463, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to dental services inextricably linked to other covered medical services. Zehra Hussain, (214) 767-4463, or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to payment of skin substitutes. Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, Rachel Radzyner, (410) 786-8215, Rebecca Ray, (667) 414-0879, and Jae Ryu, (667) 414-0765 for issues related to Drugs and Biological Products Paid Under Medicare Part B. <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov</E> , for issues related to complex drug administration. Glenn McGuirk, (410) 786-5723, or <E T="03">CLFS_Inquiries@cms.hhs.gov</E> for issues related to Clinical Laboratory Fee Schedule. Lisa Parker, (410) 786-4949, or <E T="03">FQHC-PPS@cms.hhs.gov</E> , for issues related to FQHC payments. Heidi Oumarou, (410) 786-7942, for issues related to the FQHC market basket. Michele Franklin, (410) 786-9226, or <E T="03">RHC@cms.hhs.gov</E> , for issues related to RHC payments. Kianna Banks (410) 786-3498 and Cara Meyer (667) 290-9856, for issues related to RHCs and FQHCs and Conditions for Certification or Coverage. Colleen Barbero (667) 290-8794, for issues related to Medicare Diabetes Prevention Program. Ariana Pitcher, (667) 290-8840, or <E T="03">OTP_Medicare@cms.hhs.gov</E> , for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs. Sabrina Ahmed, (410) 786-7499, or <E T="03">SharedSavingsProgram@cms.hhs.gov</E> , for issues related to the Medicare Shared Savings Program (Shared Savings Program) Quality performance standard and quality reporting requirements. Janae James, (410) 786-0801, or <E T="03">SharedSavingsProgram@cms.hhs.gov</E> , for issues related to Shared Savings Program beneficiary assignment and benchmarking methodology. Richard (Chase) Kendall, (410) 786-1000, or <E T="03">SharedSavingsProgram@cms.hhs.gov</E> , for issues related to reopening ACO payment determinations, and mitigating the impact of significant, anomalous, and highly suspect billing activity on Shared Savings Program financial calculations. Lucy Bertocci, (410) 786-3776, or <E T="03">SharedSavingsProgram@cms.hhs.gov</E> , for issues related to Shared Savings Program prepaid shared savings, advance investment payments, beneficiary notice and eligibility requirements. Rachel Radzyner, (410) 786-8215, for issues related to payment for preventative services, including preventive vaccine administration and drugs covered as additional preventive services. Elisabeth Daniel, (667) 290-8793, for issues related to the Medicare Prescription Drug Inflation Rebate Program. Genevieve Kehoe, <E T="03">Ambulatoryspecialtycare@cms.hhs.gov</E> , or 1-844-711-2664 (Option 4) for issues related to the Request for Information: Building upon the MIPS Value Pathways (MVPs) Framework to Improve Ambulatory Specialty Care. Kimberly Long, (410) 786-5702, for issues related to expanding colorectal cancer screening. Rachel Katonak, (410) 786-8564, for issues related to expanding Hepatitis B vaccine coverage. Mei Zhang, (410) 786-7837, for issues related to requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan (section 2003 of the SUPPORT Act). Katie Parker, (410) 786-0537, for issues related to Parts A and B overpayment provisions of the Affordable Care Act. Alissa Stoneking, (410)786-1120, for issues related to Parts C and D overpayment provisions of the Affordable Care Act. Amy Gruber, (410) 786-1542, for issues related to low titer O+ whole blood transfusion therapy during ground ambulance transport. Renee O'Neill, (410) 786-8821, for inquiries related to Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Danielle Drayer, (516) 965-6630, for inquiries related to Alternative Payment Models (APMs). </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Addenda Available Only Through the internet on the CMS Website:</E> The PFS Addenda along with other supporting documents and tables referenced in this final rule are available on the CMS website at <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html</E> . Click on the link on the left side of the screen titled, “PFS Federal Regulations Notices” for a chronological list of PFS <E T="04">Federal Register</E> and other related documents. For the CY 2025 PFS ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 5684k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━