HHS prescribes regulations for opioid addiction treatment reports

Medical practitioners who treat up to 275 patients in an office-based setting must provide various information to assist HHS in complying with newly established regulations regarding medication assisted treatment (MAT) of opioid use disorders. In an advance release of a Final rule set to publish in the Federal Register September 27, 2016, HHS requires information related to: (1) a practitioner’s annual caseload of patients to be reported monthly; (2) the number of patients provided behavioral health services and referred to behavioral health services; and (3) the features of the practitioner’s diversion control plan.

Background

Buprenorphine is used in MAT to help people reduce or quit their use of heroin or other opiates, such as pain relievers like morphine. Unlike methadone treatment, which must be performed in a highly structured clinic, buprenorphine is the first medication to treat opioid dependency that is permitted to be prescribed or dispensed in physician offices, significantly increasing treatment access.

HHS had increased access to MAT in an office-based setting by allowing eligible physicians to request approval to treat up to 275 patients if certain conditions are met in a previous Final rule titled “Medication Assisted Treatment for Opioid Use Disorders” (81 FR 44712, July 8, 2016) (MAT rule). The MAT rule had originally proposed requirements to ensure that patients received the full array of services that comprise evidence-based MAT and minimize the risk that the medications provided for treatment are misused or diverted (see Proposal could push up patient limit for opioid abuse treatment, Health Law Daily, March 29, 2016).

HHS also made changes to the original proposed reporting requirements based on earlier comments by adding a requirement proposing that practitioners provide reports to the Substance Abuse and Mental Health Services Administration (SAMHSA) to maintain their approval to treat up to 275 patients in a supplemental Notice of Proposed Rulemaking (SNPRM) (81 FR 44576, July 8, 2016). The purpose of the reporting requirements is to help HHS assess practitioner compliance with the additional responsibilities of practitioners who are authorized to treat up to the highest patient limit.

Reporting requirements

HHS recognized that asking practitioners to calculate and report average monthly caseload of patients receiving buprenorphine-based MAT each year could be could be burdensome and changed this reporting requirement in the Final rule. The revised text requires practitioners to report annual caseloads of patients by month. By seeking information on the annual caseload of patients by month, HHS noted that an appropriate balance between collecting valuable information needed to assess compliance with the rule and avoiding undue burden to practitioners would be struck.

In addition, the reporting requirement has been revised to request the practitioner report on the number of patients provided behavioral health services and referred to behavioral health services. By seeking information on the number of patients that were provided services and referred for behavioral health services will meet the needs of assessing compliance of the MAT rule.

HHS modified the third reporting requirement, which required that the practitioner report on the features of their diversion control plan, by striking requirements related to reporting the number of patients who: (1) completed a buprenorphine course of treatment; (2) were referred to a less intensive level of care; (3) no longer wished to take buprenorphine; or (4) no longer taking buprenorphine for reasons not listed.

Beyond scope

HHS declined to address comments requesting higher patient limits, access to buprenorphine, or SAMHSA audit practitioners to ensure compliance with the MAT rule because the comments did not relate directly to the reporting requirements of the SNPRM.