Quality & Science

Summary: Major components of the HHS final rule. Effective August 8, 2016.

by ASAM Staff | July 6, 2016

On July 6, 2016, the Department of Health and Human Services (HHS) released a final rule to increase access to medication-assisted treatment with buprenorphine products in the office setting by allowing eligible practitioners to request approval to treat up to 275 patients. The final rule also includes requirements to ensure that patients treated by these practitioners receive high-quality care, and that aim to minimize the risk of diversion. Below is a summary of the major components of the final rule, which will be effective on August 8, 2016.

Please send additional questions about the final rule to ASAM’s advocacy team at advocacy@asam.org. We will compile member questions to share with HHS as they seek to educate prescribers on the rule’s implementation.

Eligible Practitioners

To be eligible for a patient limit increase to 275, a physician must possess a current waiver to treat up to 100 patients, must have maintained that waiver without interruption for at least one year, and meet one of the following requirements:

  1. Hold “additional credentialing,” meaning board certification in addiction medicine or addiction psychiatry by the American Board of Addiction Medicine (ABAM) or the American Board of Medical Specialties (ABMS) or certification by the American Osteopathic Academy of Addiction Medicine, ABAM or ASAM; or
  2. Practice in a “qualified practice setting,” meaning a practice that:
    1. Provides professional coverage for patient medical emergencies during hours when the practitioner’s practice is closed;
    2. Provides access to case-management services for patients including referral and follow-up services for programs that provide, or financially support, the provision of services such as medical, behavioral, social, housing, employment, educational, or other related services;
    3. Uses health information technology (health IT) systems such as electronic health records, if otherwise required to use these systems in the practice setting. Health IT means the electronic systems that health care professionals and patients use to store, share, and analyze health information;
    4. Is registered for their State prescription drug monitoring program (PDMP) where operational and in accordance with Federal and State law.
    5. Accepts third-party payment for costs in providing health services, including written billing, credit, and collection policies and procedures, or Federal health benefits.

Additionally, practitioners may not have had Medicare enrollment and billing privileges revoked under 42 CFR 424.535 nor have been found to have violated the Controlled Substances Act pursuant to 21 U.S.C. 824(a) to be eligible for the higher limit. 

Other Practitioners

The rule does not extend prescribing authority to clinicians other than physicians as the original DATA 2000 statute limits the practitioners eligible for the waiver to physicians. As such, HHS does not have the authority to extend prescribing privileges to other clinicians.

Process to Request a Patient Limit of 275

Eligible physicians wishing to treat up to 275 patients may request to do so by filling out a Request for Patient Limit Increase form. This form is under final review by the federal government and will be available soon.

The form will require physicians to attest that they meet the eligibility requirements and will be able to meet the additional responsibilities for behavioral health services, care coordination, diversion control, and continuity of care in emergencies and for transfer of care in the event that they do not request renewal of the higher patient limit or their renewal request is denied.

Physicians must reaffirm their eligibility every three years by submitting a renewal Request for Patient Limit Increase form at least 90 days before the end of the waiver period. HHS has pledged to work with DEA to synchronize the waiver renewal process with the renewal of a physician’s DEA registration.

SAMHSA will approve or deny a Request for Patient Limit Increase within 45 days.

New Formulations

In the proposed rule, HHS proposed that the Secretary would establish a process by which patients who are treated with medications subject to the patient limit that have features that enhance safety or reduce diversion, as determined by the Secretary, may be counted differently toward the limit. In the final rule, HHS determined that all patients treated with medications subject to the patient limit, including new formulations, will be counted against the patient limit in the same manner. HHS may choose to revisit this issue in the future.

Counting Patients

The final rule defines a “patient” as any individual who is dispensed or prescribed covered medications by a practitioner. For example, if a practitioner provides cross-coverage for another practitioner and in the course of that coverage the covering practitioner provides a prescription for buprenorphine, the patient counts towards the cross-covering practitioner’s patient limit until the prescription or medication has expired. However, if a cross-covering practitioner is merely available for consult but does not dispense or prescribe buprenorphine while the prescribing practitioner is away, the patients being covered do not count towards the cross-covering practitioner’s patient limit.

Reporting Requirements

The proposed rule had included proposed reporting requirements for physicians treating more than 100 patients to demonstrate they were providing appropriate psychosocial interventions, abiding by recommended diversion control protocols, and otherwise providing high-quality care. Due to public comments, including ASAM’s, that the proposed reporting requirements were not structured in a way that would meet their stated ends, SAMHSA decided to delay the finalization of the reporting requirements, and has issued a Supplemental Notice of Proposed Rulemaking to solicit additional comments on the proposed reporting requirements prior to finalizing them. ASAM will submit and share comments on the proposed reporting requirements.

Emergency Situations

Physicians with a current waiver to prescribe up to 100 patients and who are not otherwise eligible to treat up to 275 patients may request a temporary (not longer than 6 months) increase to treat up to 275 patients in order to address emergency situations. An “emergency situation” is defined as a situation in which an existing State, tribal, or local system for substance use disorder services is overwhelmed or unable to meet the existing need for medication-assisted treatment as a direct consequence of a clear precipitating event. The precipitating event must have an abrupt onset, such as practitioner incapacity; natural or human-caused disaster; an outbreak associated with drug use; and result in significant death, injury, exposure to life-threatening circumstances, hardship, suffering, loss of property, or loss of community infrastructure.