Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements, 66191-66196 [2016-23277]
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Federal Register / Vol. 81, No. 187 / Tuesday, September 27, 2016 / Rules and Regulations
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42 CFR Part 8
RIN 0930–AA22
Medication Assisted Treatment for
Opioid Use Disorders Reporting
Requirements
Substance Abuse and Mental
Health Services Administration
(SAMHSA), HHS.
ACTION: Final rule.
AGENCY:
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,
SUMMARY:
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‘‘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 https://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 officebased 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.
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 (§ 8.630(b))
and the reporting requirements
(§ 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
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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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
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This final rule adopts the same basic
structure and framework as the
supplemental proposed rule. Subpart F,
Section 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
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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 § 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
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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
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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.
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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
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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
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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.
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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
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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
§ 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
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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
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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 reevaluate 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 100patient 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:
Purpose of submission
Number of
respondents
Responses/
respondent
Burden/
response
(hr.)
Total burden
(hrs.)
Hourly wage
cost
($)
Total wage
cost
($)
8.635 ...........
asabaliauskas on DSK3SPTVN1PROD with RULES
42 CFR
citation
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
VerDate Sep<11>2014
16:16 Sep 26, 2016
Jkt 238001
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
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Fmt 4700
Sfmt 4700
(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
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Federal Register / Vol. 81, No. 187 / Tuesday, September 27, 2016 / Rules and Regulations
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 275patient 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 275patient 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 275patient limit into their regular site visit
schedule.
Number of
physician reports
Year
Year
Year
Year
Year
1
2
3
4
5
..............................................................................................................................
..............................................................................................................................
..............................................................................................................................
..............................................................................................................................
..............................................................................................................................
§ 8.635 What are the reporting
requirements for practitioners whose
Request for Patient Limit Increase is
approved?
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
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.
2. Amend § 8.630 by adding paragraph
(b) to read as follows:
■
§ 8.630 What must practitioners do in
order to maintain their approval to treat up
to 275 patients?
asabaliauskas on DSK3SPTVN1PROD with RULES
*
*
*
*
*
(b) All practitioners whose Request
for Patient Limit Increase has been
approved under § 8.625 must provide
reports to SAMHSA as specified in
§ 8.635.
■ 3. Add § 8.635 to read as follows:
VerDate Sep<11>2014
16:16 Sep 26, 2016
Jkt 238001
(a) General. All practitioners whose
Request for Patient Limit Increase is
approved under § 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 §§ 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 § 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.
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Fmt 4700
Sfmt 4700
Physician costs
1,150
1,350
1,550
1,750
1,950
SAMHSA costs
$445,000
522,000
600,000
677,000
754,000
$115,000
135,000
155,000
175,000
195,000
(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
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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.
---------------------------------------------------------------------------
\1\ Covered medications means the drugs or combination of drugs
that are covered under 21 U.S.C. 823(g)(2)(C).
---------------------------------------------------------------------------
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:
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
