On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) and proposes new payment policies relating to Opioid Use Disorder (OUD) treatment. Since enactment of the SUPPORT Act in 2018, CMS has consistently implemented reforms and added covered substance use disorder (SUD) treatment services through its annual update to the Medicare Physician Fee Schedule. The Proposed Rule keeps with that theme and builds on this progress. Investors in and providers of SUD treatment services should examine the impacts of the Proposed Rule and consider submitting comments to CMS — the deadline is September 9, 2024. The Proposed Rule features the following specific to SUD services:

• Telecommunication Flexibilities for Periodic Assessment and Initiation of Treatment with Methadone
• Establishing payments to Opioid Treatment Programs for Social Determinants of Health risk assessments
• Establishing payment for new U.S. Food & Drug Administration (FDA)-approved Opioid Agonist and Antagonist Medications

Permanent Telecommunication Flexibilities

CMS proposed two changes which seek to expand access and reduce barriers for patients of Opioid Treatment Programs (OTPs) by permanently allowing telecommunication technologies for certain services.

First, CMS proposes that OTPs may furnish periodic assessments using audio-only communications technology when video is not available on a permanent basis beginning January 1, 2025. This method had been allowed on a temporary basis during COVID-19. By making this flexibility permanent, CMS aims to promote access to care and prevent disruptions in treatment for Medicare beneficiaries as data suggests that audio-only visits (or the demand therefor) increases with age of the patient, and many subpopulations of Medicare including racial/ethnic minorities, dual enrollees in Medicare and Medicaid, and those with low broadband access are more likely to use audio only telemedicine services. As CMS acknowledged, telehealth services via telephone have become regular services offerings for SUD treatment facilities since the COVID-19 pandemic.

Second, CMS proposes permitting OTPs to use audio-visual telecommunication for initiation of treatment with methadone. Specifically, CMS proposes that an OTP intake add-on service (HCPCS G2076) may be furnished via two-way audio-video technology. In February 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) made several reforms to allow audio-visual telehealth initiation for any new patient who will be treated by the OTP with methadone if a practitioner or primary care provider determines that an adequate evaluation of the patient can be accomplished via an audio-visual telehealth platform. The Proposed Rule would conform the Physician Fee Schedule with SAMHSA reforms (previously discussed in our recent blog post: Opioid Treatment Programs: SAMHSA Makes Permanent Regulatory Flexibilities) and allow for Medicare reimbursement. CMS hopes these reforms will reduce barriers to care, promote positive health outcomes, and advance health equity among Medicare beneficiaries.

Establishing Payments to Opioid Treatment Programs for Social Determinants of Health Risk Assessments (Reforms to 42 C.F.R. Part 8)

The Proposed Rule includes reforms to 42 C.F.R. Part 8 that would expand coverage under the Medicare OTP benefit by establishing payment for Social Determinants of Health (SDOH) risk assessments under several conditions. Primarily, the SDOH risk assessment must be part of any intake activities for treatment of OUD, the assessment must be medically reasonable and necessary for the diagnosis or treatment of OUD, and OTP providers must believe that unmet health-related social needs (HRSN) or the need for services identified in the assessment could interfere with the OTP’s ability to diagnose or treat the patient’s OUD.

Relatedly, CMS requests information related to the payment of coordinated care and referrals to community-based organizations that address unmet HRSN, provide harm reduction services, and/or provide recovery support services. CMS notes that under the Medicare OTP benefit, payment has been established for some services like overdose education furnished in conjunction with opioid antagonist medication or social support via group therapy. CMS acknowledges that other types of important services such as any work the OTP may undertake to coordinate care or link patients to community-based organizations is not currently reimbursed. Specifically, CMS requests information to understand if OTPs frequently work with transportation agencies, local support groups, syringe service programs, and nonprofits that provide financial supports and the types of collaborative arrangements an OTP may have with community-based organizations. CMS requests feedback on whether OTPs already receive funding for coordinated care or referral services from other public or private services.

Payment for New FDA-approved Opioid Agonist and Antagonist Medications

Finally, the Proposed Rule proposes the creation of payment codes for several new drugs under the Medicare OTP benefit, including a new Nalmefene Hydrochloride product called Opvee and a new injectable formulation of buprenorphine, Brixadi. Both of these products were recently approved by the FDA for OUD treatment and significantly expand OUD treatment options for patients.

Call to Action

The Proposed Rule should be celebrated, by beneficiaries and providers alike, as it seeks to expand Medicare coverage and payment for SUD treatment services. CMS will consider stakeholder input before finalizing these important reforms and is also seeking information about collaborative arrangements and funding for community-based providers to address HRSNs. Stakeholders in SUD should consider submitting comments and responsive information to CMS to support continued reforms to expand access and payment pathways for SUD treatment services. 

Providers and clinical personnel interested in changes to the behavioral health codes for 2025 should consider providing comments to the proposed rule. The comment period will close on September 9, 2024, 5:00 p.m. ET. Anyone may submit comments via electronic submission at this link. Additionally, commenters may submit comments by mail to:

• Regular Mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1807-P, P.O. Box 8016, Baltimore, MD 21244-8016.
• Express or Overnight Mail: 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.

If submitting via mail, please allow time for comments to be received before the closing date.

Want to Learn More?

• Opioid Treatment Programs: SAMHSA Makes Permanent Regulatory Flexibilities
• Health-Related Social Needs: Three Trends in Leveraging Community Partnerships
• Behavioral Health: CMS Innovation Model Outlines Changes for the Delivery of Integrated Behavioral and Physical Health Care
• 2023 Going Digital Health’s Behavioral Health Tech Conference: Key Investment Takeaways