[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Rules and Regulations]
[Pages 62403-62404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 8

[Docket No. 2016-0001]
RIN-0930-AA22


Medication Assisted Treatment for Opioid Use Disorders; 
Correction

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Correcting amendment.

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SUMMARY: The Health and Human Services Department (HHS) is correcting a 
final rule that appeared in the Federal Register on July 8, 2016. The 
final rule increased the maximum number of patients to whom an 
individual practitioner may dispense or prescribe certain medications, 
including buprenorphine, from 100 to 275. Practitioners are eligible 
for the increased patient limit if they have prescribed covered 
medications to up to 100 patients for at least one year pursuant to 
secretarial approval, provided that they meet certain criteria and 
adhere to several additional requirements aimed at ensuring that 
patients receive the full array of services that comprise evidence-
based medication-assisted treatment (MAT) and minimize the risks that 
medications provided for treatment are misused or diverted. One pathway 
through which practitioners may become eligible to increase their 
patient limit is by obtaining additional credentialing from one of 
several credentialing bodies. In the final rule, the name of one of the 
credentialing bodies listed was incorrect. This action provides the 
correct name.

DATES: Effective on September 9, 2016.

FOR FURTHER INFORMATION CONTACT: Jinhee Lee, Division of Pharmacologic 
Therapies, Center for Substance Abuse Treatment, SAMHSA, 5600 Fishers 
Lane, Rockville, MD 20857, (240) 276-2700, email: 
[email protected].

SUPPLEMENTARY INFORMATION: On July 8, 2016 (81 FR 44711), HHS published 
a final rule in the Federal Register, which increased the maximum 
number of patients to whom an individual practitioner may dispense or 
prescribe certain medications, including buprenorphine, from 100 to 
275. One of the pathways through which practitioners can become 
eligible to increase their patient limit is by receiving additional 
credentialing.
    In the final rule, the American Osteopathic Academy of Addiction 
Medicine (AOAAM), which provides training but not certification, was 
mistakenly included in the definition for ``additional credentialing.'' 
HHS intended to include the American Osteopathic Association (AOA) in 
this definition, not AOAAM. This intention was evident in HHS's Notice 
of Proposed Rulemaking (NPRM), published on March 30, 2016, which 
proposed defining ``board certification'' so as to include 
``subspecialty board certification in addiction medicine from the 
American Osteopathic Association (AOA) . . . .'' AOAAM, on the other 
hand, was not referenced within the NPRM. Accordingly, HHS gave the 
public notice and an opportunity to comment on its proposal to include 
AOA board certification as one of the credentials that would make 
practitioners eligible to practice at the higher patient cap. No public 
comments were received that related to AOA's role in the proposed rule.
    HHS's intention to reference AOA (not AOAAM) was also reflected in 
the preamble of the final rule; AOA board certification was referenced 
in Section B of the Regulatory Impact Analysis, which stated that 
``[t]he training requirement may be satisfied in several ways: One may 
hold board certification in . . . addiction medicine from the American 
Osteopathic Association . . . .'' HHS also explained in the preamble of 
the final rule that, ``HHS removed the term `board certification' and 
added `additional credentialing' to clarify that all practitioners who 
currently qualify to treat up to 100 patients are eligible for the 
higher patient limit if they are included as specialists as described 
in 21 U.S.C. 823

[[Page 62404]]

(g)(2)(G)(ii)(I)-(III).'' Notably, AOA board certification is 
specifically listed in 21 U.S.C. 823(g)(2)(G)(ii)(III), as amended by 
the Comprehensive Addiction and Recovery Act of 2016 (CARA), Public Law 
114-198. As a result, the listing of AOAAM instead of AOA was the 
result of a technical error that needs to be corrected immediately.
    If this error is not immediately corrected, practitioners who have 
received training from AOAAM, and who do not satisfy any of the other 
``additional credentialing'' requirements under the final rule, may 
argue that they are eligible to increase their patient limit even 
though they do not possess the qualifications that HHS has deemed 
necessary to dispense or prescribe relevant medications safely and 
effectively at the higher patient cap. In addition, the error has 
resulted in SAMHSA receiving numerous questions seeking clarification 
regarding the credentials that osteopathic providers need to have in 
order to be eligible for the higher patient limit. Failure to correct 
this error could, therefore, significantly compromise the quality of 
care delivered to patients in need of MAT and could pose a substantial 
threat to public safety.
    The technical error at issue will therefore be fixed by removing 
the reference to the ``American Osteopathic Academy of Addiction 
Medicine'' in the final rule's definition of ``additional 
credentialing,'' and inserting a reference to the ``American 
Osteopathic Association.'' It should be noted that although reference 
was made to ``subspecialty board certification'' by AOA in the NPRM, 
the term ``subspecialty'' will not be included in the final rule's 
definition of ``additional credentialing'' because CARA amended the 
Controlled Substances Act by removing the term ``subspecialty'' from 
the description of AOA board certification under 21 U.S.C. 
823(g)(2)(G)(ii)(III). CARA was enacted on July 22, 2016, after the 
final rule was published on July 8, 2016. As explained in the preamble 
of the final rule, HHS's reason for changing the definition of ``board 
certification'' in the NPRM to ``additional credentialing'' in the 
final rule was to ensure that the training credentials described in 21 
U.S.C. 823(g)(2)(G)(ii)(I)-(III) (which include AOA board 
certification) were included as eligible pathways for practicing at the 
higher patient cap. Therefore, the technical fix made to the definition 
of ``additional credentialing'' in the final rule reflects HHS's 
continuing intention to include the type of training described in 21 
U.S.C. 823(g)(2)(G)(ii)(I)-(III), as amended by CARA.

List of Subjects in 42 CFR Part 8

    Health professions, Methadone, Reporting and recordkeeping 
requirements.

    Accordingly, 42 CFR part 8 is corrected by making the following 
correcting amendment:

PART 8--MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS

0
1. The authority citation for part 8 continues to read as follows:

    Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290bb-2a, 290aa(d), 
290dd-2, 300x-23, 300x-27(a), 300y-11.

0
2. In Sec.  8.2, revise the definition of Additional Credentialing to 
read as follows:


Sec.  8.2   Definitions.

* * * * *
    Additional Credentialing means board certification in addiction 
medicine or addiction psychiatry by the American Board of Addiction 
Medicine, the American Board of Medical Specialties, or the American 
Osteopathic Association or certification by the American Board of 
Addiction Medicine, or the American Society of Addiction Medicine.
* * * * *

    Dated: September 2, 2016.
Wilma Robinson,
Deputy Executive Secretary, U.S. Department of Health and Human 
Services.
[FR Doc. 2016-21674 Filed 9-8-16; 8:45 am]
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