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Physician Limits on Buprenorphine Patients Increased

Under new federal regulations, the Health and Human Services department has determined that physicians who have prescribed buprenorphine to 100 patients for at least one year can now increase their patient limits to 275. Buprenorphine was approved for clinical use in 2002 and is used to help patients reduce or stop opiate usage. Buprenorphine is used to diminish withdrawal symptoms from and cravings for opiates and can be prescribed or dispensed in a qualified physician’s office, rather than the patient needing to be treated at a heavily structured methadone clinic.

The proposed rule received significant commentary and revision before it was finalized. Some of the major revisions include replacing the definition of “board certification” for eligible providers with an “additional credentialing” definition. Another revision clarifies the criteria for a “qualified practice setting.” The final rule also raised the proposed limit from 200 to 275.

Anticipated benefits of the increased limit include shorter waitlists for this treatment, greater parity with other medical treatments, and assistance in providing a research-based understanding of addiction.

Those who objected to the proposed rule cited drawbacks that buprenorphine is often diverted or misused and that too few subspecialists are eligible—that more providers are needed rather than higher prescribing limits. Summaries and responses regarding comments are available on the web page describing the rule.

Although the rule itself is final, the form to request the higher limit is not yet available. To receive the form and guidance information, providers should contact the SAMHSA Center for Substance Abuse Treatment (CSAT) at info@buprenorphine.samhsa.gov with the following information: contact information, data waiver number and patient limit, and a statement affirming the provider’s 100-patient certification for at least one year.

Click here to read the final rule:

https://www.federalregister.gov/articles/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders 

  1. Overview of Final Rule

The final rule adopts the same basic structure and framework as the proposed rule: Subpart A sets forth the general provisions of the rule; current subparts A, B, and C would change to subparts B, C, and D, respectively; the titles of these subparts would be revised to make it clear that they apply only to OTPs; subpart E is reserved and subpart F contains the final rule. Subpart A, § 8.1 details the scope of the rule and explains that the proposed rules in the new subpart F pertain only to those practitioners using a waiver under 21 U.S.C. 823(g)(2) with a patient limit of 101 to 275. Subpart A, § 8.2 provides the definitions that apply to the entirety of part 8 and § 8.3 discusses opioid treatment programs. Subpart F discusses the authorization to increase the patient limit to 275 patients. Subpart F, § 8.610 describes which practitioners are qualified for a patient limit of 275; subpart F, § 8.615 describes a qualified practice setting; subpart F, § 8.620 discusses the process to request a patient limit of 275; subpart F, § 8.625 details how a request will be processed; subpart F, § 8.630 describes what a practitioner must do to maintain the 275 patient limit; subpart F, § 8.635 is reserved; subpart F, § 8.640 details the renewal process for practitioners who desire to keep their 275 patient limit; subpart F, § 8.645 discusses the responsibilities of practitioners whose renewal request for the 275 patient limit was denied or who did not request for a renewal of the 275 patient limit; subpart F, § 8.650 details the conditions under which SAMHSA can suspend or revoke a patient limit increase approval; and subpart F, § 8.655 provides the rules applicable to patient limit increases in emergency situations.

HHS has made some changes to the proposed rule’s provisions, based on the comments we received. Among the significant changes are the following.

HHS has changed the highest patient limit from 200 to 275.

HHS also changed § 8.610 by revising the language in this section. This change will allow additional addiction specialists to treat up to 275 patients by including all practitioners with additional credentialing as defined in § 8.2.

HHS has decided to delay the finalization of the proposed reporting requirements in § 8.635 and is publishing elsewhere in this issue of the Federal Register a Supplemental Notice of Proposed Rulemaking to solicit additional comments on the proposed reporting requirements prior to finalizing them. We expect to finalize the reporting requirements expeditiously.

HHS has responded to the comments received on the proposed rule, and provided an explanation of each of the changes made to the proposed rule in the preamble.

General Comments

HHS received a number of comments that expressed general support and advocacy for the proposed rule. Many of these comments pointed to the lives that will be saved and the long waitlists for MAT that will be shortened. Commenters also noted that the rule provides parity with other conditions/medications and that the rule will help provide a research-based understanding of addiction.

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There were also some comments that expressed disagreement with the proposed rule. These commenters said that MAT was not as effective as traditional models and that buprenorphine is a drug of diversion and misuse, and could result in poor outcomes. Some commenters cited a need for more providers rather than higher prescribing limits. Several commenters suggested that the application and renewal procedure and the recordkeeping and reporting requirements will dissuade physicians from applying for the higher patient limit.

A comment also suggested that very few additional patients will receive addiction treatment with buprenorphine as a result of the proposed rule, due to the small number of subspecialists eligible to treat an additional 100 patients each, unclear criteria for what constitutes a qualified practice setting, and continued poor reimbursement.

Given the evidence supporting buprenorphine-based MAT as an effective treatment for opioid use disorder and the magnitude of the opioid crisis, this rule is intended to increase access to buprenorphine-based MAT, prevent diversion, and ensure quality services are provided. With respect to the comment specifically related to the issues of subspecialty board certification and unclear criteria for a qualified practice setting, the final rule addresses these issues by replacing the “board certification” definition with an “additional credentialing” definition and also provides further clarity regarding the criteria for a qualified practice setting. HHS appreciates that increasing the patient limit for certain MAT providers is a complex issue and is not the only avenue for addressing the opioid public health crisis. HHS is promoting access to all forms of MAT for opioid use disorder through multiple activities included in the Secretary’s Opioid Initiative. Given the Secretary’s authority to increase the patient limit on treatment under 21 U.S.C. 823(g)(2) by rulemaking, the rule is an essential element of a comprehensive approach to increasing access to MAT.

Physicians who have prescribed buprenorphine to 100 patients for at least one year can now increase their patient limits to 275 under new federal regulations. Review the final rule in the Federal Register.

The form to request the higher limit is not yet available. To receive the form and guidance information, contact the SAMHSA Center for Substance Abuse Treatment (CSAT) at info@buprenorphine.samhsa.gov

Please include your contact information, your data waiver number and patient limit, and a statement affirming your 100 patient certification for at least one year.

https://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine

Click here to read the final rule:

https://www.federalregister.gov/articles/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders