[Federal Register Volume 86, Number 80 (Wednesday, April 28, 2021)]
[Notices]
[Pages 22439-22440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08961]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Practice Guidelines for the Administration of Buprenorphine for 
Treating Opioid Use Disorder

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The Practice Guidelines for the Administration of 
Buprenorphine for Treating Opioid Use Disorder provides eligible 
physicians, physician assistants, nurse practitioners, clinical nurse 
specialists, certified registered nurse anesthetists, and certified 
nurse midwives, who are state licensed and registered by the DEA to 
prescribe controlled substances, an exemption from certain statutory 
certification requirements related to training, counseling and other 
ancillary services (i.e., psychosocial services).

DATES: This guidance takes effect April 28, 2021.

FOR FURTHER INFORMATION CONTACT: Neeraj Gandotra MD, Chief Medical 
Officer, Substance Abuse Mental Health Services Administration, 5600 
Fishers Lane 18E67, Rockville, MD 20857, 
[email protected].

SUPPLEMENTARY INFORMATION: 

A. Background

    The Drug Addiction Treatment Act of 2000 (DATA 2000), which amended 
the Controlled Substances Act (CSA), was passed in order to improve 
access to treatment for Opioid Use Disorder (OUD) by allowing 
practitioners to prescribe approved Schedule III through V medications 
for OUD treatment without the need to hold a separate registration for 
this purpose. The CSA permits qualified practitioners to dispense 
certain opioid treatment medications for the treatment of OUD. 
Addressing the perceived barriers around prescribing buprenorphine by 
exempting practitioners from the certification requirements related to 
training, counseling and other ancillary services (i.e., psychosocial 
services), may increase the availability of Medication-based Opioid Use 
Disorder Treatment (MOUD), and help address barriers to care for OUD. 
Buprenorphine, an FDA-approved medication for opioid use disorder, is 
an opioid partial agonist that produces effects such as euphoria or 
respiratory depression at low to moderate doses. However, these effects 
are weaker than full opioid agonists such as methadone and heroin. 
Given these properties confer a lower diversion risk, buprenorphine 
prescriptions are preferable to other medications in the office based 
setting.

B. Purpose of the Practice Guidelines

    Under certain conditions, the attached Practice Guidelines exempt 
eligible physicians, physician assistants, nurse practitioners, 
clinical nurse specialists, certified registered nurse anesthetists, 
and certified nurse midwives (hereinafter collectively referred to as 
``practitioners''), from the certification requirements related to 
training, counseling and other ancillary services (i.e., psychosocial 
services) under 21 U.S.C. 823(g)(2)(B)(i)-(ii). This action is needed 
in order to expand access to buprenorphine for opioid use disorder 
treatment. Specifically, the exemption allows these practitioners to 
treat up to 30 patients with OUD using buprenorphine without having to 
make certain training related certifications. This exemption also 
allows practitioners to treat patients with buprenorphine without 
certifying as to their capacity to provide counseling and ancillary 
services. This exemption specifically addresses reported barriers of 
the training requirement. Providers are still required to submit an 
application designated as a ``Notice of Intent'' in order to prescribe 
buprenorphine for the treatment of Opioid Use Disorder.

C. Authority: 21 U.S.C. 823(g)(2)(H)(i)(II)

Practice Guidelines for the Administration of Buprenorphine for 
Treating Opioid Use Disorder

    Pursuant to 21 U.S.C. 823(g)(2)(H)(i)(II), the Department of Health 
and Human Services (HHS), issues these practice guidelines regarding 
the eligibility of physicians, physician assistants, nurse 
practitioners, clinical nurse specialists, certified registered nurse 
anesthetists, and certified nurse midwives (hereinafter collectively 
referred to as ``practitioners'') for a waiver under 21 U.S.C. 
823(g)(2).
    The United States faces an opioid overdose epidemic that has 
engendered a public health crisis and prematurely ended thousands of 
American lives. For the year ending in August 2020, provisional data 
from the Centers for Disease Control and Prevention show that overdose 
deaths have increased 26.8 percent compared to the previous 12 months, 
to more than 88,000 deaths. These deaths disproportionately affect 
working Americans with families, with the highest rates of opioid 
overdose deaths occurring in individuals between the ages of 25 and 54. 
Those who succumb to overdose leave spouses without partners, children 
without parents, and parents without children.
    Medication-based treatment for opioid-use disorder (OUD), as part 
of a comprehensive treatment plan that may also include counseling and 
behavioral therapies, is an effective approach that can sustain 
recovery and prevent overdose. In order for a practitioner to dispense 
(including prescribe) buprenorphine for OUD, the practitioner must 
satisfy the requirements of 21 U.S.C. 823(g)(1) or 823(g)(2). Under 
Sec.  823(g)(1), ``practitioners who dispense narcotic drugs to 
individuals for maintenance treatment or detoxification treatment shall 
obtain annually a separate [DEA] registration for that purpose.'' The 
``Attorney General shall register an applicant to dispense narcotic 
drugs to individuals for maintenance treatment or detoxification 
treatment (or both).'' See 21 U.S.C. 823(g)(1).
    Alternatively, a practitioner may seek a waiver from this 
registration

[[Page 22440]]

requirement by submitting a notice of intent (NOI), with specific 
statutorily required certifications, to the Substance Abuse and Mental 
Health Services Administration (SAMHSA) within HHS. Id. at Sec.  
823(g)(2)(B). Once SAMHSA approves the waiver request and notifies the 
Drug Enforcement Administration (DEA) of that approval, DEA issues an 
X-waiver identification number authorizing that practitioner to treat 
OUD patients with buprenorphine.
    In order to be qualified for a waiver under current law, a 
practitioner must satisfy certain certification requirements related to 
training, counseling, and other ancillary services (i.e., psychosocial 
services) that are codified under 21 U.S.C. 823(g)(2)(B)(i)-(ii). The 
Secretary of HHS has determined that these requirements represent a 
perceived barrier to prescribing buprenorphine in the United States. 
The Secretary of HHS, in consultation with DEA, the Administrator of 
the Substance Abuse and Mental Health Services Administration,\1\ the 
Director of the National Institute on Drug Abuse, and the Commissioner 
of Food and Drugs, may create exemptions from the certification 
requirements under 21 U.S.C. 823(g)(2) by issuing practice guidelines 
pursuant to 21 U.S.C. 823(g)(2)(H)(i)(II). Therefore, pursuant to this 
authority, HHS hereby issues the following practice guidelines 
exemption:
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    \1\ The head of the Substance Abuse and Mental Health Services 
Administration is known as the Assistant Secretary for Mental Health 
and Substance Use following the 21st Century Cures Act (Pub. L. No: 
114-255).
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    1. With respect to the prescription of medications that are covered 
under 21 U.S.C. 823(g)(2)(C), such as buprenorphine, practitioners 
licensed under state law, and who possesses a valid DEA registration 
under 21 U.S.C. 823(f), may become exempt from the certification 
requirements related to training, counseling, and other ancillary 
services (i.e., psychosocial services) under 21 U.S.C. 823(g)(2)(B)(i)-
(ii). Consistent with the applicable statute, practitioners who meet 
the above conditions must submit an NOI in accordance with current 
procedures in order to be covered under this exemption and receive a 
waiver. However, if a practitioner selects a patient limit of 30 in the 
NOI, the practitioner will not need to certify as to the training, 
counseling, or other ancillary services requirements listed under 21 
U.S.C. 823(g)(2)(B)(i)-(ii).
    2. This exemption applies to practitioners, as defined in these 
Guidelines, who are state licensed and DEA registered.
    3. Practitioners utilizing this exemption are limited to treating 
no more than 30 patients at any one time. Time spent practicing under 
this exemption will not qualify the practitioner for a higher patient 
limit under 21 U.S.C. 823(g)(2)(B)(iii).
    4. Physician assistants, nurse practitioners, clinical nurse 
specialists, certified registered nurse anesthetists, and certified 
nurse midwives are required to be supervised by, or work in 
collaboration with, a DEA registered physician if required by State law 
to work in collaboration with, or under the supervision of, a physician 
when prescribing medications for the treatment of opioid use disorder.
    5. Practitioners who do not wish to practice under this exemption 
and its attendant 30 patient limit may seek a waiver under 21 U.S.C. 
823(g)(2) per established protocols. This means that such practitioners 
must submit an NOI that includes all of the certifications under 21 
U.S.C. 823(g)(2)(B)(i)-(iii), and qualify for a higher patient limit 
through one of the methods identified in 21 U.S.C. 823(g)(2)(B)(iii). 
More information about how to treat more than 30 patients may be found 
here (https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner).
    6. This exemption applies only to the prescription of Schedule III, 
IV, and V drugs or combinations of such drugs, covered under 21 U.S.C. 
823(g)(2)(C), such as buprenorphine. It does not apply to the 
prescribing, dispensing, or the use of Schedule II medications, such as 
methadone, for the treatment of opioid use disorders.
    7. Practitioners utilizing this exemption may only treat patients 
who are located in states where those practitioners are licensed to 
treat patients unless the practitioner is an employee or contractor of 
a department or agency of the United States who is acting in the scope 
of such employment or contract, and registered under 21 U.S.C. 823(f) 
in any State, or is using the registration of a hospital or clinic 
operated by a department or agency of the United States a registered 
under Section 823(f). The requirements in (4) also do not apply to such 
employees.

Recommendations Around Training, Education, and Psychosocial Treatment

    1. Recognizing the importance of practitioner education and 
training around the provision of comprehensive care for patients with 
OUD, practitioners treating patients under the exemption provided by 
these Practice Guidelines are strongly encouraged to utilize the HHS 
Buprenorphine Quick Start Guide.
    2. Given the multiple challenges often faced by individuals with 
substance-use disorder and the high rate of psychiatric comorbidity, 
and evidence that psychosocial treatment may improve outcomes of 
treatment compliance and retention, practitioners practicing under this 
exemption are encouraged to provide access to psychosocial services, 
such as counseling, or other ancillary services, or refer as 
appropriate to licensed behavioral health practitioners in their 
communities.
    3. Recognizing that substance-use disorder education is not yet 
uniformly integrated into medical education, colleges of medicine and 
residency training programs for nurses and physician assistants are 
strongly encouraged to develop or to continue implementing 
comprehensive training in substance-use disorder diagnosis and 
management as a component of their core, required curriculum. The 
SAMHSA Providers Clinical Support System may be used as a resource for 
technical assistance. (https://pcssnow.org/)
    The Department, along with federal partners monitoring diversion 
and enforcement like DEA, will assess impact and make formal 
recommendations to the Secretary of Health and Human Services on 
whether the guideline should be continued, discontinued, or modified.

    Approved: April 26, 2021.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2021-08961 Filed 4-27-21; 8:45 am]
BILLING CODE 4162-20-P