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-P]</DEPDOC>
<RIN>RIN 0938-AV33</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>
Proposed rule.
<SUM>
<HD SOURCE="HED">SUMMARY:</HD>
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.
</SUM>
<EFFDATE>
<HD SOURCE="HED">DATES:</HD>
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 9, 2024.
</EFFDATE>
<HD SOURCE="HED">ADDRESSES:</HD>
In commenting, please refer to file code CMS-1807-P.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
<E T="03">Electronically.</E>
You may submit electronic comments on this regulation to
<E T="03">https://www.regulations.gov.</E>
Follow the “Submit a comment” instructions.
2.
<E T="03">By regular mail.</E>
You may mail written comments to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1807-P, P.O. Box 8016, Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
<E T="03">By express or overnight mail.</E>
You may send written comments to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1807-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
<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.
Kris Corwin, (410) 786-8864, or
<E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E>
for issues related to strategies for updates to practice expense data collection and methodology.
Hannah Ahn, (814) 769-0143, or
<E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E>
for issues related to potentially misvalued services under the PFS.
Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252, 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-one.
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.
Laura Ashbaugh, (410) 786-1113, and 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 specific 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
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