81_FR_48964 81 FR 48821 - Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements

81 FR 48821 - Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration

Federal Register Volume 81, Issue 143 (July 26, 2016)

Page Range48821-48822
FR Document2016-17532

The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on August 2, 2016, to solicit comments regarding the supplemental notice of proposed rulemaking, ``Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements.'' The session will be held in Rockville, MD, to obtain direct public input from stakeholders on the proposed reporting requirements.

Federal Register, Volume 81 Issue 143 (Tuesday, July 26, 2016) 
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48821-48822]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Medication Assisted Treatment for Opioid Use Disorders Reporting 
Requirements

AGENCY: Substance Abuse and Mental Health Services Administration, 
Department of Health and Human Services (HHS).

ACTION: Notice of Public Listening Session.

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SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) announces that it will hold a public listening session on 
August 2, 2016, to solicit comments regarding the supplemental notice 
of proposed rulemaking, ``Medication Assisted Treatment for Opioid Use 
Disorders Reporting Requirements.'' The session will be held in 
Rockville, MD, to obtain direct public input from stakeholders on the 
proposed reporting requirements.

DATES: The listening session will be held on August 2, 2016, from 3:00 
to 5:00 p.m.

ADDRESS: Participation: The listening session will be held at the 
Substance Abuse and Mental Health Services Administration at 5600 
Fishers Lane, Rockville, MD 20857, Room 5N54.
    SAMHSA will post the agenda and logistical information on how to 
participate in person or by phone on https://www.eventbrite.com/e/public-listening-session-mat-for-opioid-use-disorder-reporting-requirements-tickets-26685870156 in advance of the listening session.
    The session is open to the public and the entire meeting's 
proceedings will be recorded and made publicly available. Interested 
parties may participate in person or by phone. Capacity is limited and 
registration is required. To register, go to https://www.eventbrite.com/e/public-listening-session-mat-for-opioid-use-disorder-reporting-requirements-tickets-26685870156. Registration will 
be open until we meet maximum capacity. In addition to attending the 
session in person and joining via phone, the Agency offers several ways 
to provide comments in advance of the listening session, as enumerated 
below. The forum will begin with opening remarks from the SAMHSA 
official charged with moderating the session. The session is accessible 
to persons with disabilities.
    You may submit comments using any of the following methods:
     Mail: The Substance Abuse and Mental Health Services 
Administration, 5600 Fishers Lane, Room 13E21C, Rockville, MD 20857
     Hand Delivery or Courier: 5600 Fishers Lane, Room 13E21C, 
Rockville, MD 20857 between 9 a.m. and 5 p.m., ET, Monday through 
Friday, except federal holidays.
     Email: WaiverRegulations@SAMHSA.hhs.gov.
    Each submission must include the Agency name and the docket number 
for this notice. Comments must be received by 5:00 p.m. ET on August 8, 
2016.

FOR FURTHER INFORMATION CONTACT: For information concerning the 
listening session or the live webcast, please contact: Phillip Ames, 
Special Assistant, SAMHSA, 5600 Fishers Lane, 18E61, Rockville, MD 
20857, (240) 276-2129 or email WaiverRegulations@SAMHSA.hhs.gov.

Background

    On March 30, 2016 HHS issued a Notice of Proposed Rulemaking (NPRM) 
entitled ``Medication Assisted Treatment for Opioid Use Disorders'' in 
the Federal Register. On July 8, 2016, HHS published a final version of 
this rule with the same title. The final rule increases access to 
medication-assisted treatment (MAT) with certain medications, including 
buprenorphine and combination buprenorphine/naloxone (hereinafter 
referred to as buprenorphine) medications, in office-based setting as 
authorized under section 303(g)(2) of the Controlled Substances Act 
(CSA) (21 U.S.C. 823(g)(2)). Section 303(g)(2) of the CSA allows 
individual practitioners to dispense or prescribe Schedule III, IV, or 
V controlled substances that have been approved by the Food and Drug 
Administration (FDA) without obtaining a separate registration to 
dispense narcotic maintenance and detoxification drugs under section 
303(g)(1). Section 303(g)(2)(B)(iii) of the CSA also allows qualified 
practitioners who file an initial notification of intent (NOI) to treat 
a maximum of 30 patients at a time with medications covered under 
section 303(g)(2)(C). After 1 year, the practitioner may file a second 
NOI indicating his/her intent to treat up to 100 patients at a time. 
The final rule expands access to MAT by allowing eligible practitioners 
to request approval to treat up to 275 patients under section 303(g)(2) 
of the CSA. The final rule includes requirements to help ensure that 
patients receive the full array of services that comprise evidence-
based MAT and minimize the risk that the medications provided for 
treatment are misused or diverted.
    The March 30, 2016 NPRM included a set of reporting requirements 
for practitioners who were approved to treat patients at the higher 
patient limit. The purpose of the proposed reporting requirements was 
to help HHS assess practitioner compliance with the additional 
responsibilities of practitioners who are authorized to treat up to the 
higher patient limit. The proposed reporting requirements are as 
follows:


[[Page 48822]]


    a. The average monthly caseload of patients received buprenorphine-
based MAT, per year
    b. Percentage of active buprenorphine patients (patients in 
treatment as of reporting date) that received psychosocial or case 
management services (either by direct provision or by referral) in the 
past year due to:
    1. Treatment initiation
    2. Change in clinical status
    c. Percentage of patients who had a prescription drug monitoring 
program query in the past month
    d. Number of patients at the end of the reporting year who:
    1. Have completed an appropriate course of treatment with 
buprenorphine in order for the patient to achieve and sustain recovery
    2. Are not being seen by the provider due to referral by the 
provider to a more or less intensive level of care
    3. No longer desire to continue use of buprenorphine
    4. Are no longer receiving buprenorphine for reasons other than 1-
3.

    HHS received a large number of comments on these proposed reporting 
requirements. Some commenters expressed concerns that these 
requirements were too cumbersome and would serve as a disincentive to 
providers who are considering increasing their patient limit, while 
other commenters felt that the reporting requirements were not 
stringent enough. Because of the large number of comments and the wide 
variability in their scope, HHS issued a supplemental NPRM, titled, 
``Medication Assisted Treatment for Opioid Use Disorders Reporting 
Requirements'' to solicit additional public comments about the proposed 
reporting requirements.
    In addition to seeking general comments on the proposed reporting 
requirements, HHS seeks comment on the following questions:

    a. Are there different or additional elements that should be 
reported in order to assist HHS in ensuring compliance with the final 
rule?
    b. Are there ways in which some elements can be combined that will 
lessen the burden for reporting practitioners while maintaining the 
important function of collecting information that ensure compliance 
with the final rule?
    c. Are there other ways that HHS can collect the necessary 
information to ensure compliance with the final rule?
    d. Would it be less burdensome to report on the number of patients 
in treatment for each month of the reporting period that:
    (i) Were provided counseling services at the same location as the 
practitioner, and how frequently those patients utilized the counseling 
services;
    (ii) The practitioner referred for counseling services at a 
different location?
    e. Would it be less burdensome to report on the number of patients 
at the end of the reporting year who had terminated utilization of 
covered medications?
    f. Are there other suggested changes that would be less burdensome 
while maintaining the important function of collecting information that 
ensure compliance with the final rule?

    SAMHSA will hold a public listening session to provide all 
interested parties the opportunity to share their views on the proposed 
reporting requirements and the additional questions. Members of the 
public are invited to attend and view the proceedings, with space 
available on a first-come, first-served basis (based on registration).

Draft Agenda for the August 2, 2016 Public Listening Session

--Welcome and introductions
--Proposed reporting requirements
--Open comment period
--Additional questions

Summer King,
Statistician.
[FR Doc. 2016-17532 Filed 7-25-16; 8:45 am]
 BILLING CODE 4162-20-P

Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices 48821 and personal information concerning Department of Health and Human this notice. Comments must be received individuals associated with the grant Services (HHS). by 5:00 p.m. ET on August 8, 2016. applications, the disclosure of which ACTION: Notice of Public Listening FOR FURTHER INFORMATION CONTACT: For would constitute a clearly unwarranted Session. information concerning the listening invasion of personal privacy. session or the live webcast, please Name of Committee: National Institute on SUMMARY: The Substance Abuse and contact: Phillip Ames, Special Assistant, Alcohol Abuse and Alcoholism Initial Mental Health Services Administration SAMHSA, 5600 Fishers Lane, 18E61, Review Group Clinical, Treatment and (SAMHSA) announces that it will hold Rockville, MD 20857, (240) 276–2129 or Health Services Research Review a public listening session on August 2, email WaiverRegulations@ Subcommittee. 2016, to solicit comments regarding the Date: October 11, 2016. supplemental notice of proposed SAMHSA.hhs.gov. Time: 8:30 a.m. to 6:00 p.m. rulemaking, ‘‘Medication Assisted Background Agenda: To review and evaluate grant Treatment for Opioid Use Disorders applications. On March 30, 2016 HHS issued a Reporting Requirements.’’ The session Place: National Institute on Alcohol & Notice of Proposed Rulemaking (NPRM) Alcoholism, Terrace Level Room 508–509, will be held in Rockville, MD, to obtain entitled ‘‘Medication Assisted 5635 Fishers Lane, Rockville, MD 20852. direct public input from stakeholders on Treatment for Opioid Use Disorders’’ in Contact Person: Ranga V. Srinivas, Ph.D., the proposed reporting requirements. the Federal Register. On July 8, 2016, Chief, Extramural Project Review Branch, DATES: The listening session will be National Institute on Alcohol Abuse and HHS published a final version of this held on August 2, 2016, from 3:00 to rule with the same title. The final rule Alcoholism, National Institutes of Health, 5:00 p.m. 5365 Fishers Lane, Room 2085, Rockville, increases access to medication-assisted ADDRESS: Participation: The listening treatment (MAT) with certain MD 20852, (301) 451–2067, srinivar@ mail.nih.gov. session will be held at the Substance medications, including buprenorphine Name of Committee: National Institute on Abuse and Mental Health Services and combination buprenorphine/ Alcohol Abuse and Alcoholism Initial Administration at 5600 Fishers Lane, naloxone (hereinafter referred to as Review Group, Epidemiology, Prevention Rockville, MD 20857, Room 5N54. buprenorphine) medications, in office- and Behavior Research Review SAMHSA will post the agenda and based setting as authorized under Subcommittee. logistical information on how to section 303(g)(2) of the Controlled Date: October 18, 2016. participate in person or by phone on Substances Act (CSA) (21 U.S.C. Time: 8:30 a.m. to 6:00 p.m. https://www.eventbrite.com/e/public- Agenda: To review and evaluate grant 823(g)(2)). Section 303(g)(2) of the CSA listening-session-mat-for-opioid-use- applications. allows individual practitioners to disorder-reporting-requirements-tickets- Place: National Institute on Alcohol & dispense or prescribe Schedule III, IV, 26685870156 in advance of the listening Alcoholism, Terrace Level Room 508–509, or V controlled substances that have session. 5635 Fishers Lane, Rockville, MD 20852. The session is open to the public and been approved by the Food and Drug Contact Person: Anna Ghambaryan, M.D., Administration (FDA) without obtaining Ph.D., Scientific Review Officer, Extramural the entire meeting’s proceedings will be recorded and made publicly available. a separate registration to dispense Project Review Branch, Office of Extramural narcotic maintenance and detoxification Activities, National Institute on Alcohol Interested parties may participate in person or by phone. Capacity is limited drugs under section 303(g)(1). Section Abuse and Alcoholism, 5635 Fishers Lane, Room 2019, Rockville, MD 20852, 301–443– and registration is required. To register, 303(g)(2)(B)(iii) of the CSA also allows 4032, anna.ghambaryan@nih.gov. go to https://www.eventbrite.com/e/ qualified practitioners who file an (Catalogue of Federal Domestic Assistance public-listening-session-mat-for-opioid- initial notification of intent (NOI) to Program Nos. 93.271, Alcohol Research use-disorder-reporting-requirements- treat a maximum of 30 patients at a time Career Development Awards for Scientists tickets-26685870156. Registration will with medications covered under section and Clinicians; 93.272, Alcohol National be open until we meet maximum 303(g)(2)(C). After 1 year, the Research Service Awards for Research capacity. In addition to attending the practitioner may file a second NOI Training; 93.273, Alcohol Research Programs; indicating his/her intent to treat up to 93.891, Alcohol Research Center Grants; session in person and joining via phone, the Agency offers several ways to 100 patients at a time. The final rule 93.701, ARRA Related Biomedical Research expands access to MAT by allowing and Research Support Awards., National provide comments in advance of the listening session, as enumerated below. eligible practitioners to request approval Institutes of Health, HHS) The forum will begin with opening to treat up to 275 patients under section Dated: July 20, 2016. 303(g)(2) of the CSA. The final rule Melanie J. Gray-Pantoja, remarks from the SAMHSA official charged with moderating the session. includes requirements to help ensure Program Analyst, Office of Federal Advisory The session is accessible to persons that patients receive the full array of Committee Policy. services that comprise evidence-based with disabilities. [FR Doc. 2016–17547 Filed 7–25–16; 8:45 am] You may submit comments using any MAT and minimize the risk that the BILLING CODE 4140–01–P of the following methods: medications provided for treatment are • Mail: The Substance Abuse and misused or diverted. Mental Health Services Administration, The March 30, 2016 NPRM included DEPARTMENT OF HEALTH AND 5600 Fishers Lane, Room 13E21C, a set of reporting requirements for HUMAN SERVICES Rockville, MD 20857 practitioners who were approved to • Hand Delivery or Courier: 5600 treat patients at the higher patient limit. Substance Abuse and Mental Health The purpose of the proposed reporting srobinson on DSK5SPTVN1PROD with NOTICES Fishers Lane, Room 13E21C, Rockville, Services Administration requirements was to help HHS assess MD 20857 between 9 a.m. and 5 p.m., ET, Monday through Friday, except practitioner compliance with the Medication Assisted Treatment for federal holidays. additional responsibilities of Opioid Use Disorders Reporting Requirements • Email: WaiverRegulations@ practitioners who are authorized to treat SAMHSA.hhs.gov. up to the higher patient limit. The AGENCY: Substance Abuse and Mental Each submission must include the proposed reporting requirements are as Health Services Administration, Agency name and the docket number for follows: VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\26JYN1.SGM 26JYN1

48822 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices a. The average monthly caseload of report on the number of patients in membership to the Captain of the Port, patients received buprenorphine- treatment for each month of the Buffalo. The Committee assists the based MAT, per year reporting period that: Captain of the Port, Buffalo, in b. Percentage of active buprenorphine (i) Were provided counseling services developing, reviewing, and updating the patients (patients in treatment as of at the same location as the Area Maritime Security Plan for their reporting date) that received practitioner, and how frequently area of responsibility. psychosocial or case management those patients utilized the DATES: Requests for membership should services (either by direct provision counseling services; reach the U.S. Coast Guard Captain of or by referral) in the past year due (ii) The practitioner referred for the Port, Buffalo, before August 25, to: counseling services at a different 2016. 1. Treatment initiation location? ADDRESSES: Applications for 2. Change in clinical status e. Would it be less burdensome to membership should be submitted to the c. Percentage of patients who had a report on the number of patients at Captain of the Port at the following prescription drug monitoring the end of the reporting year who address: Captain of the Port, Buffalo, program query in the past month had terminated utilization of Attention: LCDR Karen Jones, 1 d. Number of patients at the end of covered medications? f. Are there other suggested changes Fuhrmann Boulevard, Buffalo, NY the reporting year who: that would be less burdensome 14203–3189. 1. Have completed an appropriate course of treatment with while maintaining the important FOR FURTHER INFORMATION CONTACT: For buprenorphine in order for the function of collecting information questions about submitting an patient to achieve and sustain that ensure compliance with the application, or about the AMSC in recovery final rule? general, contact: 2. Are not being seen by the provider For the Northeast Ohio Region Sub- SAMHSA will hold a public listening Committee Executive Coordinator: Mr. due to referral by the provider to a session to provide all interested parties more or less intensive level of care Peter Killmer at 216–937–0136. the opportunity to share their views on For the Northwestern Pennsylvania 3. No longer desire to continue use of the proposed reporting requirements Region Sub-Committee Executive buprenorphine and the additional questions. Members Coordinator: Mr. Joseph Fetscher at 4. Are no longer receiving of the public are invited to attend and 216–937–0126. buprenorphine for reasons other view the proceedings, with space For the Western New York Region than 1–3. available on a first-come, first-served Sub-Committee Executive Coordinator: HHS received a large number of basis (based on registration). Mr. Michael Messina at 716–843–9574. comments on these proposed reporting For the Eastern New York Region Sub- Draft Agenda for the August 2, 2016 requirements. Some commenters Committee Executive Coordinator: Mr. Public Listening Session expressed concerns that these Ralph Kring at 315–343–1217. requirements were too cumbersome and —Welcome and introductions SUPPLEMENTARY INFORMATION: would serve as a disincentive to —Proposed reporting requirements providers who are considering —Open comment period Authority increasing their patient limit, while —Additional questions Section 102 of the Maritime other commenters felt that the reporting Summer King, Transportation Security Act (MTSA) of requirements were not stringent enough. Statistician. 2002 (Pub. L. 107–295) added section Because of the large number of 70112 to Title 46 of the U.S. Code, and [FR Doc. 2016–17532 Filed 7–25–16; 8:45 am] comments and the wide variability in authorized the Secretary of the BILLING CODE 4162–20–P their scope, HHS issued a supplemental Department in which the Coast Guard is NPRM, titled, ‘‘Medication Assisted operating to establish Area Maritime Treatment for Opioid Use Disorders Security Advisory Committees for any Reporting Requirements’’ to solicit DEPARTMENT OF HOMELAND port area of the United States. (See 33 additional public comments about the SECURITY U.S.C. 1226; 46 U.S.C.; 33 CFR 1.05–1, proposed reporting requirements. 6.01; Department of Homeland Security Coast Guard In addition to seeking general Delegation No. 0170.1). The MTSA comments on the proposed reporting [Docket No. USCG–2016–0449] includes a provision exempting these requirements, HHS seeks comment on AMSCs from the Federal Advisory the following questions: Area Maritime Security Advisory Committee Act (FACA), Public Law 92– Committee (AMSC), Eastern Great 436, 86 Stat. 470 (5 U.S.C. App.2). The a. Are there different or additional Lakes and Regional Sub-Committee AMSCs assist the Captain of the Port in elements that should be reported in Vacancies the development, review, update, and order to assist HHS in ensuring compliance with the final rule? AGENCY:Coast Guard, DHS. exercising of the Area Maritime Security b. Are there ways in which some Notice; Solicitation for ACTION: Plan for their area of responsibility. elements can be combined that will Membership. Such matters may include, but are not lessen the burden for reporting limited to: Identifying critical port practitioners while maintaining the SUMMARY: This notice requests infrastructure and operations; important function of collecting individuals interested in serving on the identifying risks (threats, srobinson on DSK5SPTVN1PROD with NOTICES information that ensure compliance Area Maritime Security Committee vulnerabilities, and consequences); with the final rule? (AMSC), Eastern Great Lakes, and the determining mitigation strategies and c. Are there other ways that HHS can four regional sub-committees: Northeast implementation methods; developing collect the necessary information to Ohio Region, Northwestern and describing the process to ensure compliance with the final Pennsylvania Region, Western New continually evaluate overall port rule? York Region, and Eastern New York security by considering consequences d. Would it be less burdensome to Region submit their applications for and vulnerabilities, how they may VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\26JYN1.SGM 26JYN1


Document Created: 2018-02-08 08:00:44
Document Modified: 2018-02-08 08:00:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of Public Listening Session.
DatesThe listening session will be held on August 2, 2016, from 3:00 to 5:00 p.m.
ContactFor information concerning the listening session or the live webcast, please contact: Phillip Ames, Special Assistant, SAMHSA, 5600 Fishers Lane, 18E61, Rockville, MD 20857, (240) 276-2129 or email [email protected]
FR Citation81 FR 48821 
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