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Summary of the Final Rule on Annual Reporting Requirements for Practitioners Authorized to Treat 275 Patients with Buprenorphine

Below is a summary of the Department of Health and Human Services’ (HHS) final rule on the annual reporting requirements for practitioners who are authorized to treat up to 275 patients with buprenorphine in the office setting. HHS made significant changes to the final rule based on ASAM’s comments on the supplemental proposed rule, as well as comments from other organizations and individuals.

Please send additional questions about the final rule to ASAM’s advocacy team at advocacy@asam.org.

Overview

The final rule adopts the same basic structure and framework as the supplemental proposed rule. It describes what the reporting requirements are for practitioners whose Request for Patient Limit Increase application is approved. The reporting requirements apply to all practitioners who are approved for the higher patient limit of 275. The reports must be submitted within 30 days following the anniversary date of a practitioner’s Request for Patient Limit Increase approval, and during this period on an annual basis thereafter or on another annual schedule as determined by the Substance Abuse and Mental Health Services Administration. Practitioners will be required to report:

  1. Their annual caseload of patients by month
  2. The number of patients provided behavioral health services and the number referred to behavioral health services
  3. Features of their diversion control plan.

Annual Caseloads of Patients by Month

The supplemental proposed rule’s first reporting requirement asked practitioners to calculate “the average monthly caseload of patients receiving buprenorphine-based MAT, per year.” HHS recognized that asking practitioners to calculate and report averages could be burdensome and so has changed this reporting requirement. The revised text in the final rule now asks practitioners to report annual caseloads of patients by month.

Number of Patients Provided Behavioral Health Services and Referred to Behavioral Health Services

The supplemental proposed rule’s second reporting requirement asked practitioners to calculate the “percentage of active buprenorphine patients (patients in treatment as of reporting date) that received psychosocial or case management services (either by direct provision or by referral) in the past year due to: 1) Treatment initiation and 2) Change in clinical status.” HHS received many comments requesting clarification or specification on this requirement, so they replaced the second reporting requirement in the final rule to instead require the practitioner to report on the number of patients provided behavioral health services and referred to behavioral health services.

Features of Practitioner’s Diversion Control Plan

The supplemental proposed rule’s third reporting requirement asked practitioners to calculate the “percentage of patients who had a PDMP query in the past month.” The intention behind this requirement was to assess a practitioner’s compliance with the requirements related to a diversion control plan. Since the comments received were more broadly focused on various aspects of diversion control, HHS modified the third reporting requirement in the final rule to require the practitioner to report on the features of their diversion control plan.

Fourth Proposed Requirement Struck

In response to comments by ASAM and other stakeholders, HHS struck the fourth proposed reporting requirement, which would have asked practitioners to report the number of patients who had “completed an appropriate course of treatment” or were no longer in treatment for other reasons. ASAM and other commenters successfully persuaded HHS to remove this requirement, given its misguided implication that treatment for a chronic disease is temporary and can be “completed.”

Forthcoming Additional Guidance

Additional detail and instructions regarding these reporting requirements will be provided in the practitioner reporting form, which will be available for public comment soon. Specifically, guidance on how to calculate the numbers for each reporting requirement will be issued by HHS. Practitioners may be required to submit supporting data and documentation along with the annual report; future guidance will be provided for more information. Additionally, HHS will explore developing a form that can be submitted electronically through which practitioners can submit the required data.