81 FR 62403 - Medication Assisted Treatment for Opioid Use Disorders; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 175 (September 9, 2016)

Page Range		62403-62404
FR Document		2016-21674

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.

Federal Register, Volume 81 Issue 175 (Friday, September 9, 2016)

[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Rules and Regulations]
[Pages 62403-62404]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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: 
Jinhee.Lee@samhsa.hhs.gov.

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]
 BILLING CODE P

Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Rules and Regulations 62403

TABLE 1—GENERAL SUPERFUND SECTION
State Site name City/county Notes a

* * * * * * *
CA .................... Argonaut Mine ............................................................................................................ Jackson.

* * * * * * *
CO .................... Bonita Peak Mining District ........................................................................................ San Juan County.

* * * * * * *
IN ...................... West Vermont Drinking Water Contamination ........................................................... Indianapolis.

* * * * * * *
LA ..................... SBA Shipyard ............................................................................................................. Jennings.
MT .................... Anaconda Aluminum Co Columbia Falls Reduction Plant ........................................ Columbia Falls.
NY .................... Wappinger Creek ....................................................................................................... Dutchess County.

* * * * * * *
OH .................... Valley Pike VOCs ....................................................................................................... Riverside.

* * * * * * *
PR .................... Dorado Ground Water Contamination ....................................................................... Dorado.

* * * * * * *
TX ..................... Eldorado Chemical Co., Inc. ...................................................................................... Live Oak.
WV .................... North 25th Street Glass and Zinc .............................................................................. Clarksburg.
a A = Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS score need not be greater
than or equal to 28.50).

* * * * * and minimize the risks that medications Osteopathic Association (AOA) in this
[FR Doc. 2016–21615 Filed 9–8–16; 8:45 am] provided for treatment are misused or definition, not AOAAM. This intention
BILLING CODE 6560–50–P diverted. One pathway through which was evident in HHS’s Notice of
practitioners may become eligible to Proposed Rulemaking (NPRM),
increase their patient limit is by published on March 30, 2016, which
DEPARTMENT OF HEALTH AND obtaining additional credentialing from proposed defining ‘‘board certification’’
HUMAN SERVICES one of several credentialing bodies. In so as to include ‘‘subspecialty board
the final rule, the name of one of the certification in addiction medicine from
42 CFR Part 8 credentialing bodies listed was the American Osteopathic Association
[Docket No. 2016–0001] incorrect. This action provides the (AOA) . . . .’’ AOAAM, on the other
correct name. hand, was not referenced within the
RIN–0930–AA22 NPRM. Accordingly, HHS gave the
DATES: Effective on September 9, 2016.
public notice and an opportunity to
Medication Assisted Treatment for FOR FURTHER INFORMATION CONTACT:
comment on its proposal to include
Opioid Use Disorders; Correction Jinhee Lee, Division of Pharmacologic
AOA board certification as one of the
Therapies, Center for Substance Abuse
AGENCY: Substance Abuse and Mental credentials that would make
Treatment, SAMHSA, 5600 Fishers
Health Services Administration, HHS. practitioners eligible to practice at the
Lane, Rockville, MD 20857, (240) 276–
ACTION: Correcting amendment. higher patient cap. No public comments
2700, email: Jinhee.Lee@
were received that related to AOA’s role
SUMMARY: The Health and Human samhsa.hhs.gov.
in the proposed rule.
Services Department (HHS) is correcting SUPPLEMENTARY INFORMATION: On July 8, HHS’s intention to reference AOA
a final rule that appeared in the Federal 2016 (81 FR 44711), HHS published a (not AOAAM) was also reflected in the
Register on July 8, 2016. The final rule final rule in the Federal Register, which preamble of the final rule; AOA board
increased the maximum number of increased the maximum number of certification was referenced in Section B
patients to whom an individual patients to whom an individual of the Regulatory Impact Analysis,
practitioner may dispense or prescribe practitioner may dispense or prescribe which stated that ‘‘[t]he training
certain medications, including certain medications, including requirement may be satisfied in several
buprenorphine, from 100 to 275. buprenorphine, from 100 to 275. One of ways: One may hold board certification
Practitioners are eligible for the the pathways through which in . . . addiction medicine from the
increased patient limit if they have practitioners can become eligible to American Osteopathic Association
prescribed covered medications to up to increase their patient limit is by . . . .’’ HHS also explained in the
100 patients for at least one year receiving additional credentialing. preamble of the final rule that, ‘‘HHS
pursuant to secretarial approval, In the final rule, the American removed the term ‘board certification’
ehiers on DSK5VPTVN1PROD with RULES

provided that they meet certain criteria Osteopathic Academy of Addiction and added ‘additional credentialing’ to
and adhere to several additional Medicine (AOAAM), which provides clarify that all practitioners who
requirements aimed at ensuring that training but not certification, was currently qualify to treat up to 100
patients receive the full array of services mistakenly included in the definition patients are eligible for the higher
that comprise evidence-based for ‘‘additional credentialing.’’ HHS patient limit if they are included as
medication-assisted treatment (MAT) intended to include the American specialists as described in 21 U.S.C. 823

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62404 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Rules and Regulations

(g)(2)(G)(ii)(I)–(III).’’ Notably, AOA List of Subjects in 42 CFR Part 8 recognition of their authority to regulate
board certification is specifically listed Health professions, Methadone, hunting under established guidelines.
in 21 U.S.C. 823(g)(2)(G)(ii)(III), as Reporting and recordkeeping This rule allows the establishment of
amended by the Comprehensive requirements. season bag limits and, thus, harvest at
Addiction and Recovery Act of 2016 levels compatible with populations and
(CARA), Public Law 114–198. As a Accordingly, 42 CFR part 8 is habitat conditions.
result, the listing of AOAAM instead of corrected by making the following
DATES: This rule takes effect on
AOA was the result of a technical error correcting amendment:
September 9, 2016.
that needs to be corrected immediately. ADDRESSES: You may inspect comments
If this error is not immediately PART 8—MEDICATION ASSISTED
TREATMENT FOR OPIOID USE received on the special hunting
corrected, practitioners who have regulations and Tribal proposals during
received training from AOAAM, and DISORDERS
normal business hours at U.S. Fish and
who do not satisfy any of the other 1. The authority citation for part 8
■ Wildlife Headquarters, 5275 Leesburg
‘‘additional credentialing’’ requirements continues to read as follows: Pike, Falls Church, VA 22041–3803, or
under the final rule, may argue that they
Authority: 21 U.S.C. 823; 42 U.S.C. 257a, at http://www.regulations.gov at Docket
are eligible to increase their patient
290bb–2a, 290aa(d), 290dd–2, 300x–23, No. FWS–HQ–MB–2015–0034.
limit even though they do not possess
300x–27(a), 300y–11. FOR FURTHER INFORMATION CONTACT: Ron
the qualifications that HHS has deemed
necessary to dispense or prescribe ■ 2. In § 8.2, revise the definition of W. Kokel, U.S. Fish and Wildlife
relevant medications safely and Additional Credentialing to read as Service, Department of the Interior, MS:
effectively at the higher patient cap. In follows: MB, 5275 Leesburg Pike, Falls Church,
addition, the error has resulted in VA 22041–3803; (703) 358–1967.
§ 8.2 Definitions.
SAMHSA receiving numerous questions SUPPLEMENTARY INFORMATION:
seeking clarification regarding the * * * * *
Additional Credentialing means board Background
credentials that osteopathic providers
need to have in order to be eligible for certification in addiction medicine or The Migratory Bird Treaty Act of July
the higher patient limit. Failure to addiction psychiatry by the American 3, 1918 (16 U.S.C. 703 et seq.),
correct this error could, therefore, Board of Addiction Medicine, the authorizes and directs the Secretary of
significantly compromise the quality of American Board of Medical Specialties, the Department of the Interior, having
care delivered to patients in need of or the American Osteopathic due regard for the zones of temperature
MAT and could pose a substantial threat Association or certification by the and for the distribution, abundance,
to public safety. American Board of Addiction Medicine, economic value, breeding habits, and
The technical error at issue will or the American Society of Addiction times and lines of flight of migratory
therefore be fixed by removing the Medicine. game birds, to determine when, to what
reference to the ‘‘American Osteopathic * * * * * extent, and by what means such birds or
Academy of Addiction Medicine’’ in the Dated: September 2, 2016.
any part, nest, or egg thereof may be
final rule’s definition of ‘‘additional taken, hunted, captured, killed,
Wilma Robinson,
credentialing,’’ and inserting a reference possessed, sold, purchased, shipped,
Deputy Executive Secretary, U.S. Department carried, exported, or transported.
to the ‘‘American Osteopathic of Health and Human Services.
Association.’’ It should be noted that In the May 27, 2016, Federal Register
[FR Doc. 2016–21674 Filed 9–8–16; 8:45 am] (81 FR 34226), we proposed special
although reference was made to
BILLING CODE P migratory bird hunting regulations for
‘‘subspecialty board certification’’ by
AOA in the NPRM, the term the 2016–17 hunting season for certain
‘‘subspecialty’’ will not be included in Indian tribes, under the guidelines
the final rule’s definition of ‘‘additional DEPARTMENT OF THE INTERIOR described in the June 4, 1985, Federal
credentialing’’ because CARA amended Register (50 FR 23467). The guidelines
the Controlled Substances Act by Fish and Wildlife Service respond to tribal requests for Service
removing the term ‘‘subspecialty’’ from recognition of their reserved hunting
the description of AOA board 50 CFR Part 20 rights, and for some tribes, recognition
certification under 21 U.S.C. [Docket No. FWS–HQ–MB–2015–0034; of their authority to regulate hunting by
823(g)(2)(G)(ii)(III). CARA was enacted FF09M21200–167–FXMB1231099BPP0] both tribal members and nonmembers
on July 22, 2016, after the final rule was on their reservations. The guidelines
RIN 1018–BA70
published on July 8, 2016. As explained include possibilities for:
in the preamble of the final rule, HHS’s Migratory Bird Hunting; Migratory Bird (1) On-reservation hunting by both
reason for changing the definition of Hunting Regulations on Certain tribal members and nonmembers, with
‘‘board certification’’ in the NPRM to Federal Indian Reservations and hunting by nontribal members on some
‘‘additional credentialing’’ in the final Ceded Lands for the 2016–17 Season reservations to take place within Federal
rule was to ensure that the training frameworks but on dates different from
credentials described in 21 U.S.C. AGENCY: Fish and Wildlife Service, those selected by the surrounding
823(g)(2)(G)(ii)(I)–(III) (which include Interior. State(s);
AOA board certification) were included ACTION: Final rule. (2) On-reservation hunting by tribal
as eligible pathways for practicing at the members only, outside of usual Federal
higher patient cap. Therefore, the SUMMARY: This rule prescribes special frameworks for season dates and length,
ehiers on DSK5VPTVN1PROD with RULES

technical fix made to the definition of migratory bird hunting regulations for and for daily bag and possession limits;
‘‘additional credentialing’’ in the final certain Tribes on Federal Indian and
rule reflects HHS’s continuing intention reservations, off-reservation trust lands, (3) Off-reservation hunting by tribal
to include the type of training described and ceded lands. This rule responds to members on ceded lands, outside of
in 21 U.S.C. 823(g)(2)(G)(ii)(I)–(III), as tribal requests for U.S. Fish and Wildlife usual framework dates and season
amended by CARA. Service (hereinafter Service or we) length, with some added flexibility in

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Document Created: 2018-02-09 13:15:28
Document Modified: 2018-02-09 13:15:28

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Correcting amendment.
Dates		Effective on September 9, 2016.
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]
FR Citation		81 FR 62403
CFR Associated		Health Professions; Methadone and Reporting and Recordkeeping Requirements