[Federal Register Volume 81, Number 187 (Tuesday, September 27, 2016)]
[Rules and Regulations]
[Pages 66191-66196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23277]


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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: Final rule.

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SUMMARY: This final rule outlines annual reporting requirements for 
practitioners who are authorized to treat up to 275 patients with 
covered medications in an office-based setting. This final rule will 
require practitioners to provide information on their annual caseload 
of patients by month, the number of patients provided behavioral health 
services and referred to behavioral health services, and the features 
of the practitioner's diversion control plan. These reporting 
requirements will help the Department of Health and Human Services 
(HHS) ensure compliance with the requirements of the final rule, 
``Medication Assisted Treatment for Opioid Use Disorders,'' published 
in the Federal Register on July 8, 2016.

DATES: Effective Date: This final rule is effective on October 27, 
2016.

FOR FURTHER INFORMATION CONTACT: Jinhee Lee, Pharm.D., Public Health 
Advisor, Center for Substance Abuse Treatment, 240-276-2700

SUPPLEMENTARY INFORMATION:

Electronic Access

    This Federal Register document is also available from the Federal 
Register online database through Federal Digital System (FDsys), a 
service of the U.S. Government Printing Office. This database can be 
accessed via the Internet at http://www.gpo.gov/fdsys.

I. Background

    On July 8, 2016, HHS issued a final rule entitled ``Medication 
Assisted Treatment for Opioid Use Disorders'' in the Federal Register 
(81 FR 44712). That final rule increases access to medication-assisted 
treatment (MAT) with covered medications,\1\ in an office-based 
setting, by allowing eligible physicians to request approval to treat 
up to 275 patients if certain conditions are met. 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. HHS issued a supplemental Notice of Proposed Rulemaking 
(SNPRM) along with the final rule, which included reporting 
requirements for practitioners who increase their patient limit to 275.
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    \1\ Covered medications means the drugs or combination of drugs 
that are covered under 21 U.S.C. 823(g)(2)(C).
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A. Regulatory History

    On March 30, 2016, HHS issued a Notice of Proposed Rulemaking, 
``Medication Assisted Treatment for Opioid Use Disorders.'' On July 8, 
2016, HHS issued a final rule which finalized the regulation with the 
exception of sections relating to the requirement to provide reports to 
SAMHSA (Sec.  8.630(b)) and the reporting requirements (Sec.  8.635). 
Also on July 8, 2016, HHS published a Supplemental Notice of Proposed 
Rulemaking (SNPRM) in the Federal Register which proposed reporting 
requirements for practitioners whose Request for Patient Limit Increase 
is approved under Section 8.625. The purpose of the reporting 
requirements is to help HHS assess practitioner compliance with the 
additional responsibilities of

[[Page 66192]]

practitioners who are authorized to treat up to the highest patient 
limit, as outlined in the final rule, ``Medication Assisted Treatment 
for Opioid Use Disorders.'' 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.
    The comment period for the SNPRM ended on August 8, 2016. HHS 
received 37 comments electronically and nine additional comments from a 
public listening session which was held on August 2, 2016. 
Additionally, HHS received 27 comments about the reporting requirements 
during the comment period for the Medication Assisted Treatment Notice 
for Proposed Rulemaking (NPRM) issued in March 2016. Comments primarily 
came from individuals who currently prescribe covered medications and 
national organizations representing practitioners and public health 
agencies. HHS also received several comments during conversations with 
the Department of Defense and the Department of Veterans Affairs and 
incorporated this feedback into this final rule.

B. Overview of Final Rule

    This final rule adopts the same basic structure and framework as 
the supplemental proposed rule. Subpart F, Section[thinsp]8.635 
describes what the reporting requirements are for practitioners whose 
Request for Patient Limit Increase application is approved.
    HHS has made some changes to the proposed reporting requirements 
based on the comments we received with respect to the SNPRM. HHS has 
also updated Section 8.630 by adding the requirement proposed in the 
NPRM that practitioners need to provide reports to SAMHSA as specified 
in Section 8.635 to maintain their approval to treat up to 275 
patients.
    HHS has responded to the comments received in response to the March 
2016 NPRM and this SNPRM, and provided an explanation of each of the 
changes made to the proposed rule in the preamble.

II. Provisions of the Proposed Rule and Analysis and Reponses to Public 
Comments

A. General Comments

    HHS received numerous comments providing support for the proposed 
reporting requirements. Commenters stated that the requirements would 
be particularly valuable in minimizing diversion and improving access 
to and quality of care. However, other commenters expressed concerns 
that the reporting requirements were too burdensome and would limit the 
number of practitioners who apply for the increased patient limit, 
particularly for individual practitioners or small group practices. 
Others expressed that the reporting requirements should be consistent 
for all practitioners prescribing buprenorphine for MAT. Some 
commenters also stated that there was no evidence that the reporting 
requirements would improve the quality of patient care or minimize 
misuse or diversion. Other commenters noted that other areas of 
medicine do not have reporting requirements.
    HHS has modified the reporting requirements in response to the 
comments. Given the importance of ensuring practitioners comply with 
the Medication Assisted Treatment for Opioid Disorders requirements 
while minimizing their reporting burden, we believe that the updated 
reporting requirements as outlined in Sec.  [thinsp]8.635 and further 
specified in report form instructions to be issued after finalization 
of this rule, strike the appropriate balance. Additional detail 
regarding these reporting requirements will be provided in the 
practitioner reporting form which will be available for public comment 
shortly after finalization of this rule.
    HHS also received a variety of comments related to the issue of MAT 
that did not specifically relate to the SNPRM but generally fell into 
five main categories. The categories and comments are described below.
Need for Clarification
    Comment: HHS received a comment requesting clarification on how the 
information collected will be used.
    Response: The information collected through these reporting 
requirements will enable HHS to assess compliance with the requirements 
of 42 CFR part 8, subpart F.
    Comment: HHS received a comment requesting clarification on how to 
calculate the numbers for each reporting requirement.
    Response: Guidance on how to calculate the numbers for each 
reporting requirement will be issued by HHS.
    Comment: HHS received a comment requesting clarification on whether 
the requirements apply to all practitioners approved for the higher 
limit, or only those who qualify with the qualified practice setting 
criteria.
    Response: The reporting requirements apply to all practitioners who 
are approved for the higher patient limit of 275.
    Comment: HHS received a comment requesting clarification about 
what, if any, supporting data and documentation will be required along 
with the annual report.
    Response: Practitioners may be required to submit supporting data 
and documentation along with the annual report. Future guidance will be 
provided for more information.
    Comment: HHS received a comment asking whether there are specific 
benchmarks practitioners are required to meet when they report 
percentages.
    Response: HHS is not requiring practitioners to meet specific 
benchmarks.
    Comment: HHS received a comment inquiring about the implications of 
42 CFR part 2, and how information obtained through the reporting 
requirements will be used if patients do not provide consent to use 
their information.
    Response: 42 CFR part 2 protects the identity of individuals as 
substance use disorder patients and prohibits the disclosure of any 
information that would identify an individual as a substance use 
disorder patient. The reporting requirements do not seek patient 
identifying information; therefore, the requirements are not in 
conflict with the restrictions of 42 CFR part 2.
Final Rule To Increase Patient Limit
    HHS received several comments regarding the final rule, 
``Medication Assisted Treatment for Opioid Use Disorders,'' published 
in the Federal Register on July 8, 2016. One commenter stated that the 
highest patient limit should be higher than 275. Another commenter 
recommended that there be no additional requirements associated with 
increasing the patient limit from 100 to 275. Other commenters 
expressed concerns that the final rule does not require practitioners 
to ensure patients receive the full array of services, prevent 
diversion, or follow nationally recognized evidence-based guidelines. 
An additional commenter recommended that SAMHSA audit practitioners to 
ensure that they are in compliance with the rule. A final commenter 
requested clarification regarding whether hospitalists who work in an 
acute inpatient hospital facility are eligible for the higher patient 
limit because they do not track patients after they are discharged.
    Response: Comments related to the final rule, Medication Assisted 
Treatment for Opioid Use Disorders, that do not directly relate to the

[[Page 66193]]

proposed reporting requirements which were the subject of the SNPRM, 
are outside the scope of this final rule and will not be addressed in 
this preamble.
Access to Buprenorphine
    HHS received several comments pertaining to access to 
buprenorphine. One comment expressed concerns about the impact of 
workforce shortages on access, and another commenter stated that 
clinical pharmacists should be allowed to prescribe buprenorphine, 
which would increase access. An additional commenter recommended that 
HHS work with stakeholders to explore mechanisms to address systemic 
barriers.
    Response: These comments do not relate to the reporting 
requirements under 42 CFR part 8, subpart F, and therefore, will not be 
addressed in this preamble.
Comprehensive Addiction and Recovery Act of 2016
    Comments: HHS received a small number of comments about the 
Comprehensive Addiction and Recovery Act of 2016 (CARA). One commenter 
asked whether physician assistants and nurse practitioners are required 
to report quality and patient outcomes data. Another commenter 
requested additional information on training requirements.
    Response: Comments related to CARA do not relate to the reporting 
requirements, and therefore, will not be addressed in this preamble.
Other Comments
    Comments: HHS received a number of comments that did not relate to 
reporting requirements, including a comment about the impact of the 
Drug Enforcement Administration's (DEAs) narcotic prescribing 
guidelines on the rights of people living with chronic pain, a comment 
about the impact of negative perceptions on individuals who receive 
MAT, a comment about the importance of ensuring that Drug Addiction 
Treatment Act of 2000 (DATA 2000) patients receive behavioral support 
services, a comment that the proposed reporting requirements would also 
be beneficial for those practitioners who are not seeking the higher 
patient limit increase but treat individuals with opioid use disorders, 
a comment to combine the existing opioid treatment program reporting 
requirements with those stated in this final rule, and a comment about 
the importance of coordination across HHS.
    Response: These comments do not relate to the reporting 
requirements, and therefore, will not be addressed in this preamble.

B. Subpart F

    The average monthly caseload of patients receiving buprenorphine-
based MAT, per year.
    Comments: HHS received a comment recommending that the first 
proposed reporting requirement, ``The average monthly caseload of 
patients receiving buprenorphine-based MAT, per year'' be replaced with 
the following two questions: ``(1) For the final 3 months of the 
reporting year, what was the average monthly caseload of patients 
receiving buprenorphine-based MAT? and (2) Are you currently accepting 
new opioid use disorder patients requiring MAT?''
    An additional commenter recommended that HHS collect the following 
baseline data points: Total number of patients admitted that year, 
total number of patients carried over from the previous year, and total 
number of patients discharged.
    Response: HHS recognized that asking practitioners to calculate and 
report averages could be burdensome and has, therefore, changed this 
reporting requirement. The revised text now asks practitioners to 
report annual caseloads of patients by month. By seeking information on 
the annual caseload of patients by month, HHS believes this updated 
reporting requirement, as further elaborated upon in the proposed 
report form instructions, will strike the appropriate balance between 
collecting valuable information needed to assess compliance with the 
rule and avoiding undue burden to practitioners.
Summary of Regulatory Changes
    For the reasons set forth in the proposed rule and considering the 
comments received, HHS replaced this reporting requirement with one 
that asks the practitioner to report annual caseload of patients by 
month.
    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 and (2) Change in clinical status.
    Comments: HHS received numerous comments about the second proposed 
reporting requirement, ``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 and (2) Change in 
clinical status.'' One commenter requested clarification on how 
psychosocial and case management services are defined and another 
commenter requested clarification on how clinical status is defined. 
Another commenter stated that psychosocial or case management services 
are not required or normative according to the evidence base. Another 
commenter expressed concerns that this reporting requirement will 
require patients to receive behavioral health services, but many will 
be unable to do so and will, therefore, refuse treatment. An additional 
commenter stated that this proposed requirement is irrelevant because 
so many patients receive services from a 12-step program.
    Commenters provided several suggestions for alternative reporting 
requirements about psychosocial and case management services. One 
commenter suggested that practitioners be required to report the 
percentage of patients who had one hour of counseling in the past 
month. Another commenter recommended that the reporting requirement be 
divided into two separate measures: ``(1) The number referred to 
psychosocial or case management services, and (2) the number who 
actually received psychosocial or case management services.'' An 
additional commenter recommended that the proposed reporting 
requirement be replaced with the following two questions: ``(1) The 
percentage of patients receiving psychosocial counseling and/or other 
appropriate support services; and (2) The percentage of patients 
receiving case management services.'' Another commenter recommended 
that the proposed reporting requirement be replaced with: ``(1) The 
number of patients who were provided psychosocial or case management 
services at the same location as the practitioner, and how frequently 
those patients utilized the services; and (2) the number of patients 
the practitioner referred for psychosocial or case management services 
at a different location.'' An additional commenter recommended that 
practitioners be required to report on the number of patients who were 
provided counseling services at the same location as the practitioner 
and how frequently those patients utilized the counseling services. One 
commenter also recommended that practitioners be required to provide 
information on the frequency, location, and type of psychosocial 
services provided. Another commenter recommended that practitioners be 
required to report whether the referral was to a more intensive or less 
intensive level of care.

[[Page 66194]]

Finally, one commenter recommended HHS collect data on referrals and 
behavioral health service provision using a six-point Likert scale.
    Response: This reporting requirement has been revised and now asks 
the practitioner to report on the number of patients provided 
behavioral health services and referred to behavioral health services. 
By seeking information on the number of patients that were provided 
services and referred for behavioral health services, HHS believes this 
updated reporting requirement, as further elaborated upon in the report 
form instructions, will strike the appropriate balance between 
collecting valuable information needed to assess compliance with the 
rule and avoiding undue burden to practitioners.
Summary of Regulatory Changes
    For the reasons set forth in the proposed rule and considering the 
comments received, HHS replaced the second reporting requirement with 
one that requires the practitioner to report on the number of patients 
provided behavioral health services and referred to behavioral health 
services.
    Percentage of patients who had a prescription drug monitoring 
program query in the past month.
    Comments: HHS received several comments about the proposed 
reporting requirement, ``Percentage of patients who had a PDMP query in 
the past month.'' One commenter stated that this data would not be 
informative because his practice conducts these queries for all 
patients. This commenter also stated that the state PDMP should provide 
this information instead. Another commenter suggested that the PDMP 
query should take place quarterly. An additional commenter stated that 
HHS should identify a way to collect similar data in Missouri, which 
does not have a PDMP. One commenter recommended that practitioners also 
be asked about the number of patients who had a PDMP query before the 
prescriptions were filled.
    Another commenter stated that practitioners receive alerts from 
local pharmacies and the State if a patient receiving buprenorphine 
attempts to fill another opioid prescription by any practitioner, and 
asked whether this information could be used as a response for this 
reporting requirement. The commenter noted that they do not routinely 
run PDMP data on patients receiving buprenorphine, but do query PDMP 
data for every controlled substance refilled by phone.
    HHS also received several comments focused more broadly on 
diversion control. One commenter recommended that SAMHSA provide 
guidelines for practitioners to develop diversion control plans. 
Another commenter suggested that HHS require practitioners with a 
waiver under DATA 2000 to participate in PDMPs. Several commenters also 
recommended that HHS ask about the number of patients who received 
urine drug screens, the results of drug screens, and the number of 
patients who received call-backs for pill counts. Several commenters 
noted that not every practitioner has access to a PDMP and encouraged 
HHS to use language that would apply in those situations. Finally, one 
commenter recommended that HHS ask about PDMP use and drug-use 
monitoring screening tests using a six-point Likert scale.
    Response: The intention of including PDMP queries was to assess a 
practitioner's compliance with the rule's requirements related to a 
diversion control plan. In light of the comments received, which 
focused more broadly on various aspects of diversion control, HHS 
determined that the best way to satisfy the intent of the proposal and 
assess compliance is to seek information about the features of the 
practitioner's diversion control plan, as required in Sec.  8.620, more 
generally.
Summary of Regulatory Changes
    For the reasons set forth in the proposed rule and considering the 
comments received, HHS modified the third reporting requirement to 
require the practitioner to report on the features of his or her 
diversion control plan.
    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 practitioner due to referral by the practitioner to a 
more or less intensive level of care; (3) No longer desire to continue 
use of buprenorphine; and (4) Are no longer receiving buprenorphine for 
reasons other than 1-3.
    Comments: HHS received numerous comments about the proposed 
reporting requirement, ``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 practitioner due to referral by the 
practitioner to a more or less intensive level of care; (3) No longer 
desire to continue use of buprenorphine; and (4) Are no longer 
receiving buprenorphine for reasons other than 1-3.'' A large number of 
commenters expressed concern with the first item, noting that it 
suggests that buprenorphine treatment is temporary and/or that 
individuals who receive it are not in recovery. One commenter expressed 
concern with the third and fourth item, noting that it is difficult to 
differentiate between these two subsets of patients. Some commenters 
expressed that it is difficult to determine what number of patients 
``sustain recovery'' and that SAMHSA should provide guidance on what 
constitutes an appropriate course of treatment. Another commenter 
stated that a practitioner is unable to control whether a patient 
follows through on a referral.
    Other commenters recommended alternative questions to ask for this 
proposed reporting requirement, including: The percentage of patients 
who are prescribed an average dose of 16 mg or less; the percentage of 
patients who left treatment because the practitioner terminated 
treatment due to non-compliance; patient mortality rates; the number of 
patients who left treatment because of the financial cost of treatment; 
and the number of patients who left treatment to receive treatment in 
an either higher or lower intensity setting or were deemed successful.
    Another commenter stated that the data collected in this reporting 
requirement should not include those lost to follow-up or relapse. 
Finally, an additional commenter stated that some patients at the 
commenter's facility graduate from treatment and only use counselors as 
needed. The commenter stressed that these patients should not be 
counted as patients not receiving treatment.
    Response: HHS determined that the proposed requirement will be too 
burdensome for practitioners. Therefore, HHS is not including this 
reporting requirement in Subpart F.
Additional Reporting Requirements
    Comments: HHS received several comments recommending additional 
reporting requirements for practitioners. One commenter recommended 
that the reporting requirements focus on quality measures rather than 
process measures. Another commenter recommended that HHS create a core 
set of requirements that practitioners attest to on an annual basis, 
which could include both quality and process measures.
    Other commenters recommended HHS collect data on: The amount of 
buprenorphine that patients receive; the number of times they receive 
buprenorphine; the number of active patients for whom third party 
reimbursement was provided; patient mortality rates; frequency of 
patient visits; and the percentage of

[[Page 66195]]

prescriptions written for less than 30 days, 30-59 days, 60-89 days, 
and 90 days or more.
    Response: Because HHS aims to strike the appropriate balance 
between collecting valuable information to assess compliance with 
Subpart F and minimizing the burden on practitioners, these proposed 
reporting requirements will not be added. HHS believes that the 
requirements included in this final rule are sufficient to ensure 
compliance with the assurances to which the practitioner attests to in 
the Request for Patient Limit Increase.
Alternative Ways To Meet and Provide Reporting Requirements
    Comments: HHS received a number of comments proposing alternative 
ways to collect data from practitioners. One commenter suggested that 
HHS obtain information by adding questions about psychosocial treatment 
to DEA's questions as an alternative to the proposed reporting 
requirements. Another commenter stated that the DEA audit program 
should be sufficient to ensure compliance. Other commenters suggested 
that data could be obtained from the state PDMP, from electronic 
medical record systems, or from insurance claims data. Finally one 
commenter recommended HHS incorporate these reporting requirements into 
the set of measures associated with financial incentives under the 
Centers for Medicare & Medicaid Services' new Medicare Incentive 
Payment System's program.
    Response: The proposed alternative ways to collect data from 
practitioners will not generate all of the information HHS is seeking 
through the proposed reporting requirements. Therefore, HHS will not 
collect the data using any of these approaches.
    Comments: HHS received several comments recommending that there be 
an electronic form through which practitioners can submit the required 
data.
    Response: HHS will explore developing a form that can be submitted 
electronically through which practitioners can submit the required 
data.
    Comments: HHS received several comments recommending HHS convene an 
expert panel to review and re-evaluate the reporting requirements 
either prior to adoption or after the first reporting period.
    Response: HHS received numerous public comments regarding the 
reporting requirements during the comment period for the Medication 
Assisted Treatment for Opioid Use Disorders NPRM (published in March 
2016), and during the comment period for the reporting requirements 
proposed in the SNPRM (published in July 2016). These comments were 
received from a variety of stakeholders, including experts in the 
field. Therefore, HHS does not believe that convening an expert panel 
is necessary to ensure that the reporting requirements are appropriate.
    Comment: HHS received a comment recommending that reporting 
requirements be voluntary.
    Response: HHS believes that making these requirements voluntary 
would dramatically compromise the quality and amount of data received. 
Therefore, HHS will make these requirements mandatory in order to 
ensure that HHS is able to assess compliance with the requirements of 
42 CFR part 8, subpart F.
    Comment: HHS received a comment recommending using the reporting 
requirement information to determine whether practitioners with the 
100-patient waiver should be able to increase their patient limit to 
275.
    Response: Practitioners who are subject to the 100-patient limit 
are not required to report data.
    Comments: HHS received comments recommending collecting reporting 
data from practitioners more than once per year.
    Response: HHS believes that requiring practitioners to submit data 
more than once per year would be unduly burdensome.

III. Collection of Information Requirements

    The SNPRM called for new collections of information under the 
Paperwork Reduction Act of 1995. The final rule calls for much of the 
same collections of information as the SNPRM. As defined in 
implementing regulations, ``collection of information'' comprises 
reporting, recordkeeping, monitoring, posting, labeling, and other 
similar actions. In this section, HHS first identifies and describes 
the types of information waivered practitioners must collect and report 
and then HHS provides an estimate of the total annual burden. The 
estimate covers the employees' time for reviewing and posting the 
collections required.
    Title: Medication Assisted Treatment for Opioid Use Disorders 
Reporting Requirements.
    Reporting, 42 CFR 8.635: Reporting will be required annually to 
assess compliance with the requirements of 42 CFR part 8, subpart F. 
Reporting requirements will include a request for information 
regarding: (1) Annual caseload of patients by month; (2) number of 
patients provided behavioral health services and referred to behavioral 
health services; and (3) features of the practitioner's diversion 
control plan. These requirements will be further specified in the 
report form instructions to be issued after finalization of this rule.
    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  (hr.)       (hrs.)         cost  ($)            ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.635..........................  Annual Report....           1,350                1                3            4,050           $64.47         $261,104
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comment: HHS received a comment stating that the estimated burden 
of three hours per year is inaccurate.
    Response: While the commenter stated that the estimated burden of 
three hours per year is inaccurate, the commenter did not provide 
evidence to support their claim. As a result, HHS retains the original 
estimate of three hours per year. More information on this estimate can 
be found below in the Regulatory Impact Analysis.

IV. Regulatory Impact Analysis

    HHS has examined the impact of this final 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). HHS has determined that this final rule is 
not a significant regulatory action as defined by Executive Order 
12866, and will not have a significant economic impact on a substantial 
number of small entities. Although the reporting requirements

[[Page 66196]]

have changed since the proposed rule, they have not done so in a way 
that would alter their estimated impact. As described below, the 
estimated costs associated with this final rule are below one million 
dollars each year, and the estimated per-practitioner burden is three 
hours annually, supporting the conclusion that this rule will not have 
a significant economic impact on a substantial number of small 
entities.
    Under this final rule practitioners approved to treat up to 275 
patients will have to submit information about their practice annually 
to SAMHSA for purposes of monitoring regulatory compliance. The goal of 
the reporting requirement is to ensure that practitioners are providing 
buprenorphine treatment in compliance with the final rule Medication 
Assisted Treatment for Opioid Use Disorders (81 FR 44711). It is 
anticipated that the data for the reporting requirement can be pulled 
directly from an electronic or paper health record, and that 
practitioners will not have to update their record-keeping practices 
after receiving approval to treat up to 275 patients. We estimate that 
compiling and submitting the report would require approximately 1 hour 
of physician time and 2 hours of administrative time. According to the 
U.S. Bureau of Labor Statistics, the average medical and health 
services manager's hourly pay in 2014 was $49.84, and the average 
hourly wage for a physician was $93.74. After adjusting upward by 100 
percent to account for overhead and benefits, these wages correspond to 
a cost of $99.68 and $187.48 per hour, respectively. The cost of this 
reporting requirement per practitioner approved for the 275-patient 
limit is estimated to be the cost of 1 hour of a practitioner's time 
plus 2 hours of an administrator's time.
    As noted above, using the mid-point estimate, we estimate that 
1,150 practitioners will request approval for the 275-patient limit in 
year 1 and 200 practitioners will request a 275-patient waiver in 
subsequent years. We assume that all of these requests will be 
approved. The costs associated with this reporting requirement are 
reported below. In addition, it is estimated that SAMHSA will incur a 
cost of $100 per practitioner approved for the 275-patient limit to 
process the practitioner data reporting requirement. These costs are 
reported below as well.
    We assume DEA will not incur additional costs in association with 
this final rule as DEA will incorporate site visits for practitioners 
with the 275-patient limit into their regular site visit schedule.

----------------------------------------------------------------------------------------------------------------
                                                                Number of
                                                                physician      Physician costs    SAMHSA costs
                                                                 reports
----------------------------------------------------------------------------------------------------------------
Year 1....................................................             1,150          $445,000          $115,000
Year 2....................................................             1,350           522,000           135,000
Year 3....................................................             1,550           600,000           155,000
Year 4....................................................             1,750           677,000           175,000
Year 5....................................................             1,950           754,000           195,000
----------------------------------------------------------------------------------------------------------------

List of Subjects in 42 CFR Part 8

    Health professions, Methadone, Reporting and recordkeeping 
requirements.

    For the reasons stated in the preamble, HHS amends 42 CFR part 8 as 
follows:

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. Amend Sec.  8.630 by adding paragraph (b) to read as follows:


Sec.  8.630  What must practitioners do in order to maintain their 
approval to treat up to 275 patients?

* * * * *
    (b) All practitioners whose Request for Patient Limit Increase has 
been approved under Sec.  [thinsp]8.625 must provide reports to SAMHSA 
as specified in Sec.  [thinsp]8.635.

0
3. 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) General. All practitioners whose Request for Patient Limit 
Increase is approved under Sec.  [thinsp]8.625 must submit to SAMHSA 
annually a report along with documentation and data, as requested by 
SAMHSA, to demonstrate compliance with applicable provisions in 
Sec. Sec.  [thinsp]8.610, 8.620, and 8.630.
    (b) Schedule. The report must be submitted within 30 days following 
the anniversary date of a practitioner's Request for Patient Limit 
Increase approval under Sec.  8.625, and during this period on an 
annual basis thereafter or on another annual schedule as determined by 
SAMHSA.
    (c) Content of the Annual Report. The report shall include 
information concerning the following, as further detailed in report 
form instructions issued by the Secretary:
    (1) The annual caseload of patients by month.
    (2) Numbers of patients provided behavioral health services and 
referred to behavioral health services.
    (3) Features of the practitioner's diversion control plan.
    (d) Discrepancies. SAMHSA may check reports from practitioners 
prescribing under the higher patient limit against other data sources 
to the extent allowable under applicable law. If discrepancies between 
reported information and other data are identified, SAMHSA may require 
additional documentation from the practitioner.
    (e) Noncompliance. 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: September 21, 2016.
Kana Enomoto,
Principal Deputy Administrator, Substance Abuse and Mental Health 
Services Administration.
    Approved: September 22, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-23277 Filed 9-23-16; 4:15 pm]
 BILLING CODE 4162-20-P