SAMHSA’s Proposal to Increase Buprenorphine Patient Limit: Panacea or Placebo?

By Larry K. Houck –

The Substance Abuse and Mental Health Services Administration (“SAMHSA”) has published a proposed rule that would increase the number of patients with opioid abuse disorder that a qualified physician can treat with buprenorphine. Medication Assisted Treatment for Opioid Use Disorders, 81 Fed. Reg. 17,639 (Mar. 30, 2016). Three weeks ago the Centers for Disease Control and Prevention (“CDC”) released opioid therapy and prescribing guidelines for chronic pain (see our previous post here). Both documents represent federal efforts to address what SAMHSA characterizes as “an unprecedented increase in prescription opioid abuse, heroin use and opioid-related overdose deaths.” 81 Fed. Reg. at 17,650. The CDC guidelines set out cautionary opioid therapy practices while the SAMHSA rule would expand patient access to medication assisted treatment (“MAT”). SAMHSA cites evidence that the current maximum 100-patient limit is a barrier for patient access to needed treatment. Id. at 17,651. The proposed rule would expand access to MAT by doubling the maximum number of patients that a qualified practitioner could treat for opioid use disorder with buprenorphine to 200. Practitioners authorized to treat the higher patient number would be required “to accept greater responsibility for ensuring behavioral health services and care coordination are received and for ensuring quality assurance and improvement practices, diversion control, and continuity of care in emergencies” in addition to compliance with SAMHSA’s data reporting and monitoring requirements. Id. at 17,640.

Currently, under the federal Controlled Substances Act (“CSA”), qualified practitioners can prescribe, administer or dispense buprenorphine products for the treatment of opioid use disorder in an office, community hospital, health department or correctional facility. 21 U.S.C. § 823(g)(2). To qualify, the practitioner must be a physician, hold a valid medical license and DEA registration, have the capacity to refer patients for counseling and other ancillary services, and have completed required training. 21 U.S.C. § 823(g)(2)(G). The practitioner submits notification of intent to dispense or prescribe buprenorphine to a maximum of 30 patients at a time for use in maintenance or detoxification treatment. 21 U.S.C. § 823(g)(2)(B)(iii). This precludes the practitioner from having to obtain a separate DEA registration as an opioid treatment program (“OTP”-formerly referred to as a “narcotic treatment program.”) The practitioner may file a second notification of intent after a year to increase the number of patients they can treat to 100 patients at a time. Id. SAMHSA’s proposed rule would increase the maximum number of patients to 200 that a practitioner could treat at one time if they meet certain criteria. To be eligible to treat up to 200 patients, practitioners must have held a waiver to treat 100 patients for at least one year without interruption and possess a subspecialty board certification in addiction psychiatry or addiction medicine or practice in a qualified practice setting. Medication Assisted Treatment, at 17,660. Practitioners cannot have had their enrollment and billing privileges in Medicare revoked or have been found to have violated the CSA. Id. Practitioners meeting these requirements must submit a request to increase their patient limit to SAMHSA certifying that they will “adhere to nationally recognized evidence-based guidelines for the treatment of patients with opioid use disorders” as well as “adhere to a diversion plan to manage the covered medications and reduce the possibility of diversion of covered medications from legitimate treatment use.” Id. at 17,661.

SAMHSA will approve or deny a practitioner’s request within 45 days of receipt. Id. Practitioners approved to treat the increased number of patients must submit reports, documentation and data to SAMHSA to demonstrate compliance, which may include requests for information about the average monthly caseload of MAT patients per year, percentage of active patients “that received psychosocial or case management services” in the prior year, percentage who had a prescription drug monitoring query in the prior month and number of patients at the end of the reporting year who completed treatment or no longer receive buprenorphine. Id. at 17,661-62. Practitioners would submit reports within a year after the date SAMHSA approves their request. Id. SAMHSA may verify reports with other data sources including prescription drug monitoring programs (“PDMPs”). Id. at 17,662. The agency may suspend a practitioner’s approval in order to protect the public health and safety, and revoke it if the practitioner made misrepresentations or the practitioner no longer satisfies requirements or has violated the CSA. Id.

While inviting interested parties to submit comments on all aspects of the proposed rule, SAMHSA poses specific question areas for comment. For example:

• Would a prescribing limit other than 200 patients proposed by the rule be more appropriate?
• Is the level of training required to request a patient limit increase appropriate?
• Are there other ways to affirm practitioner competence without specialty board certification?
• Are there additional ways for a practitioner to become eligible to apply for the increased patient limit?
• What costs will be associated with compliance with the rule’s requirements and how many practitioners will be able to fulfill them?
• How many patients must a physician treat to make training, administrative and other requirements not cost prohibitive depending on clinical environment?
• Is requiring renewal of the waiver every three years sufficient or should practitioners renew more frequently?
• Should SAMHSA synchronize the three-year waiver renewal with the practitioner’s DEA registration?
• How many practitioners not currently eligible to treat 200 patients would as a result of the rule, take steps to qualify?
• How many practitioners eligible to treat 200 patients will seek to do so?
• Should SAMHSA combine the reporting with other existing reporting requirements?
• Does the proposed rule strike the appropriate balance between ensuring that the required credentials are obtainable for interested practitioners?
• Are MAT programs practical to implement?
• Are reporting requirements perceived as a barrier to participation?

Id. at 17,658-59.

SAMHSA “hope[s]” that the proposed rule “will stimulate broader availability of high-quality MAT both in specialized addiction treatment settings and throughout more mainstream health care delivery systems.” Id. at 17,640. In our opinion, to fulfill that hope, the proposed rule’s graduated MAT authority for the first 30 patients, then 100 patients and finally 200 patients over two years is reasonable. Practitioners who cannot comply with treating 30 patients should not be authorized to treat up to 200 patients. Conscientious practitioners may conclude that they cannot responsibly treat more than 30 or 100 patients. Doubling the number of patients for practitioners already providing MAT may require expending only minimal additional resources. However, qualified practitioners may perceive detailed reporting requirements as too onerous to offer MAT or increase their patient numbers. Increased scrutiny and enforcement by SAMHSA and DEA may deter some practitioners. For the proposed rule to increase availability of treatment, SAMHSA should tailor regulatory requirements and costs to protect patient health and safeguard against controlled substance diversion, making them as least burdensome as possible. For example, if SAMHSA determines that waivers should be renewed every three years, it should synchronize their renewal with the practitioner’s DEA registration cycle. In addition, with accessibility to state PDMPs, SAMHSA may be able to monitor MAT activity for specific practitioners without requiring the submission of detailed annual reports.

SAMHSA must receive comments to the proposed rule no later than May 31, 2016.