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)

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, 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: [email protected].
    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 [email protected].

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