[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Proposed Rules]
[Pages 44576-44579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 8

RIN 0930-AA22


Medication Assisted Treatment for Opioid Use Disorders Reporting 
Requirements

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

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: On March 30, 2016, the U.S. Department of Health and Human 
Services (HHS) published a Notice of Proposed Rulemaking (NPRM) to 
increase the highest patient limit for qualified physicians to treat 
opioid use disorder under section 303(g)(2) of the Controlled 
Substances Act (CSA). On July 6, 2016, HHS published a final rule based 
on the NPRM but delayed finalizing the reporting requirements outlined 
in the NPRM. In this Supplemental Notice of Proposed Rulemaking 
(SNPRM), HHS seeks further comment on the same reporting requirements 
outlined in the NPRM. These reporting requirements would require annual 
reporting by practitioners who are approved to treat up to 275 patients 
under subpart F to help HHS ensure compliance with the requirements of 
the ``Medication Assisted Treatment for Opioid Use Disorders'' final 
rule published elsewhere in this issue of the Federal Register. HHS 
will consider the public comments on this SNPRM as well as any comments 
already received on the March 30, 2016 NPRM before issuing a final rule 
pertaining to the reporting requirements.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on August 8, 2016.

ADDRESSES: You may submit comments, identified by Regulatory 
Information Number (RIN) 0930-AA22, by any of the following methods:
     Electronically: Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for submitting 
comments.
     Regular Mail or Hand Delivery or Courier: Written comments 
mailed by regular mail must be sent to the following address ONLY: The 
Substance Abuse and Mental Health Services Administration, Department 
of Health and Human Services, Attn: Jinhee Lee, SAMHSA, 5600 Fishers 
Lane, Room 13E21C, Rockville, Maryland 20857. Please allow sufficient 
time for mailed comments to be received before the close of the comment 
period.
     Express or Overnight Mail: Written comments sent by hand 
delivery, or regular, express or overnight mail must be sent to the 
following address ONLY: The Substance Abuse and Mental Health Services 
Administration, Department of Health and Human Services, Attn: Jinhee 
Lee, SAMHSA, 5600 Fishers Lane, Room 13E21C, Rockville, Maryland 20857.
    Instructions: To avoid duplication, please submit only one copy of 
your comments by only one method. All submissions received must include 
the agency name and docket number or RIN for this rulemaking. All 
comments received will become a matter of public record and will be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For detailed instructions on submitting 
comments and additional information on the rulemaking process and 
viewing public comments, see the ``Public Participation'' heading of 
the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jinhee Lee, Pharm.D., Public Health 
Advisor, Center for Substance Abuse Treatment, 240-276-0545, Email 
address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Purpose

    The purpose of this Supplemental Notice of Proposed Rulemaking 
(SNPRM) is to solicit additional comment on the proposed reporting 
requirements in the U.S. Department of Health and Human Services (HHS) 
March 30, 2016 Notice of Proposed Rulemaking (NPRM) on Medication 
Assisted Treatment for Opioid Use Disorders under section 303(g)(2) of 
the Controlled Substances Act (CSA) (81 FR 17639). These requirements 
will assist HHS in ensuring practitioner compliance with the 
requirements of 42 CFR part 8, subpart F.

[[Page 44577]]

B. Summary of Major Provisions

    These proposed regulatory provisions, which amend Sec.  8.635 of 42 
CFR part 8, subpart F, would establish annual reporting requirements 
for practitioners who are approved to treat up to 275 patients under 42 
CFR part 8, subpart F.

C. Summary of Impacts

    A summary of the anticipated impact of the reporting requirements, 
along with the other provisions of 42 CFR part 8, subpart F, was 
provided in the NPRM, dated March 30, 2016. Please see the NPRM, I. 
Executive Summary, Paragraph C (Summary of Impacts) for a summary of 
impacts of the reporting requirements in the context of 42 CFR part 8, 
subpart F.

II. Public Participation

Comments Invited

    HHS invites interested parties to submit comments on all aspects of 
this proposal. All comments received before the close of the comment 
period are available for viewing by the public, including any 
personally identifiable and/or confidential information that is 
included in a comment. We post all comments received as soon as 
possible after they have been received on the following Web site: 
http://www.regulations.gov. Follow the search instructions on that Web 
site to view public comments.
    Comments received before the close of the comment period will also 
be available for public inspection, generally beginning approximately 3 
weeks after publication of the proposed rule, at the headquarters of 
the Substance Abuse and Mental Health Services Administration, 5600 
Fishers Lane, Rockville, Maryland 20857, Monday through Friday of each 
week from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view 
public comments, call 240-276-1660.
    We will consider all comments we receive by the date and time 
specified in the DATES section of this preamble, and will respond to 
the comments in the preamble of the final rule. Please allow sufficient 
time for mailed comments to be received before the close of the comment 
period.

III. 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. Elsewhere in this issue of the Federal Register, 
HHS is publishing a final rule with the same title. That 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 21 U.S.C. 823(g)(2). Section 
303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) 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). Section 303(g)(2)(B)(iii) of the CSA allows 
qualified practitioners who file an initial notification of intent 
(NOI) to treat a maximum of 30 patients at a time. 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 also 
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 proposed regulatory provisions in this SNPRM will help HHS 
assess practitioner compliance with the requirements of 42 CFR part 8, 
subpart F.

IV. Summary of SNPRM

    In the NPRM, HHS proposed 42 CFR, part 8, subpart F, Sec.  8.635 to 
describe the reporting requirements for practitioners whose Request for 
Patient Limit Increase is approved under Sec.  8.625. The purpose of 
the reporting requirements is to help HHS assess practitioner 
compliance with the additional responsibilities of practitioners who 
are authorized to treat up to the higher patient limit, as outlined in 
the MAT final rule published elsewhere in this issue of the Federal 
Register. Reporting is an integral component of HHS's approach to 
increase access to MAT while helping to 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. While HHS received many comments on the burden of 
these requirements, the comments did not provide specific suggestions 
on how HHS can ensure compliance in a manner that is not overly 
burdensome to practitioners. HHS seeks additional comment on the 
proposed reporting requirements:

a. The average monthly caseload of patients receiving 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.

    In addition, HHS seeks comment on the following questions:
    Are there different or additional elements that should be reported 
in order to assist HHS in ensuring compliance with the final rule?
    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?
    Are there other ways that HHS can collect the necessary information 
to ensure compliance with the final rule?
    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?
    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?
    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?

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), agencies are 
required to

[[Page 44578]]

provide notice in the Federal Register and solicit public comment 
before a collection of information requirement is submitted to the 
Office of Management and Budget (OMB) for review and approval. In order 
to fairly evaluate whether changes to an information collection should 
be approved by the OMB, section 3506(c)(2)(A) of the PRA requires that 
we solicit comment on the following issues:
    1. Whether the information collection is necessary and useful to 
carry out the proper functions of the agency;
    2. The accuracy of the agency's estimate of the information 
collection burden;
    3. The quality, utility, and clarity of the information to be 
collected; and
    4. Recommendations to minimize the information collection burden on 
the affected public, including automated collection techniques.
    Under the PRA, the time, effort, and financial resources necessary 
to meet the information collection requirements referenced in this 
section are to be considered in rulemaking. We explicitly seek, and 
will consider, public comment on our assumptions as they relate to the 
PRA requirements summarized in this section. This proposed rule 
includes changes to information collection requirements, that is, 
reporting, recordkeeping or third-party disclosure requirements, as 
defined under the PRA (5 CFR part 1320). Some of the provisions would 
involve changes from the information collections set out in the 
previous regulations.
    Information collection requirements would be:
    Reporting, 42 CFR 8.635: Reporting will be required annually to 
ensure that eligibility requirements are being maintained and that 
waiver conditions are being fulfilled. Reporting requirements may 
include a request for information regarding: (1) The average monthly 
caseload of patients receiving buprenorphine-based MAT, per year; (2) 
the percentage of active buprenorphine patients (patients in treatment 
as of reporting date) who received psychosocial or case management 
services (either by direct provision or by referral) in the past year 
due to treatment initiation or change in clinical status; (3) 
Percentage of patients who had a prescription drug monitoring program 
query in the past month; (4) Number of patients at the end of the 
reporting year who: (a) Have completed an appropriate course of 
treatment with buprenorphine in order for the patient to achieve and 
sustain recovery, (b) Are not being seen by the provider due to 
referral by the provider to a more or less intensive level of care, (c) 
No longer desire to continue use of buprenorphine, (d) Are no longer 
receiving buprenorphine for reasons other than (a) through (c). To 
facilitate public comment, we have placed a draft version of the 
collection template in the public docket.
    Annual burden estimates for these requirements are summarized in 
the following table:

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                                     Purpose of        Number of        Responses/        Burden/        Total burden     Hourly wage    Total wage cost
        42 CFR Citation              submission       respondents       respondent    response (hour)      (hours)          cost ($)           ($)
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8.635..........................  Annual Report....           1,350                1                3            4,050            64.47          261,104
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    For more detailed estimates, please refer to the public docket, 
which includes a copy of the draft supporting statement submitted as 
part of the NPRM and associated with this information collection.

VI. Regulatory Impact Analysis

    HHS has examined the impact of this proposed rule under Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act of 1980 (Pub. L. 96-
354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4, March 22, 1995), and Executive Order 13132 on 
Federalism (August 4, 1999) and included it in the NPRM published on 
March 30, 2016. Please refer to the NPRM for this analysis (81 FR 
17639).

List of Subjects in 42 CFR Part 8

    Health professions, Methadone, Reporting and recordkeeping 
requirements.

    For the reasons stated in the preamble, HHS proposes to amend 42 
CFR part 8 as follows:

PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS

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

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

0
2. Add Sec.  8.635 to read as follows:


Sec.  8.635  What are the reporting requirements for practitioners 
whose Request for Patient Limit Increase is approved?

    (a) All practitioners whose Request for Patient Limit Increase is 
approved under Sec.  8.625 must submit reports to SAMHSA, along with 
documentation and data, as requested by SAMHSA, to demonstrate 
compliance with Sec.  8.620, applicable eligibility requirements 
specified in Sec.  8.610, and all attestation requirements in Sec.  
8.620(b).
    (b) Reporting requirements may include a request for information 
regarding:
    (1) The average monthly caseload of patients receiving 
buprenorphine-based MAT, per year.
    (2) 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:
    (i) Treatment initiation.
    (ii) Change in clinical status.
    (3) Percentage of patients who had a prescription drug monitoring 
program query in the past month; and
    (4) Number of patients at the end of the reporting year who:
    (i) Have completed an appropriate course of treatment with 
buprenorphine in order for the patient to achieve and sustain recovery.
    (ii) Are not being seen by the provider due to referral by the 
provider to a more or less intensive level of care.
    (iii) No longer desire to continue use of buprenorphine.
    (iv) Are no longer receiving buprenorphine for reasons other than 
paragraphs (b)(4)(i) through (iii) of this section.
    (c) The report must be submitted within twelve months after the 
date that a practitioner's Request for Patient Limit Increase is 
approved under Sec.  8.625, and annually thereafter.
    (d) SAMHSA may check reports from practitioners prescribing under 
the higher patient limit against other existing data sources, such as 
PDMPs. If discrepancies between reported information and other existing 
data are identified, SAMHSA may require additional documentation from

[[Page 44579]]

practitioners whose reports are identified as including these 
discrepancies.
    (e) Failure to submit reports under this section, or deficient 
reports, may be deemed a failure to satisfy the requirements for a 
patient limit increase, and may result in the withdrawal of SAMHSA's 
approval of the practitioner's Request for Patient Limit Increase.

    Dated: June 30, 2016.
Kana Enomoto,
Principal Deputy Administrator, Substance Abuse and Mental Health 
Services Administration.
    Approved: June 30, 2016.

Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-16069 Filed 7-6-16; 8:45 am]
 BILLING CODE 4162-20-P