Medication Assisted Treatment for Opioid Use Disorders, 44711-44739 [2016-16120]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Rules and Regulations]
[Pages 44711-44739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16120]



[[Page 44711]]

Vol. 81

Friday,

No. 131

July 8, 2016

Part III





Department of Health and Human Services





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42 CFR Part 8





 Medication Assisted Treatment for Opioid Use Disorders; Final Rule

Federal Register / Vol. 81 , No. 131 / Friday, July 8, 2016 / Rules 
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 8

RIN 0930-AA22


Medication Assisted Treatment for Opioid Use Disorders

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

ACTION: Final rule.

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SUMMARY: This final rule increases access to medication-assisted 
treatment (MAT) with buprenorphine and the combination buprenorphine/
naloxone (hereinafter referred to as buprenorphine) in the office-based 
setting as authorized under the United States Code. Section 303(g)(2) 
of the Controlled Substances Act (CSA) allows individual practitioners 
to dispense or prescribe Schedule III, IV, or V controlled substances 
that have been approved by the Food and Drug Administration (FDA). 
Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who 
file an initial notification of intent (NOI) to treat a maximum of 30 
patients at a time. After 1 year, the practitioner may file a second 
NOI indicating his/her intent to treat up to 100 patients at a time. 
This final rule will expand access to MAT by allowing eligible 
practitioners to request approval to treat up to 275 patients under 
section 303(g)(2) of the CSA. The final rule also includes requirements 
to 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.

DATES: Effective Date: This final rule is effective on August 8, 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

    Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows 
individual practitioners to dispense or prescribe Schedule III, IV, or 
V controlled substances that have been approved by the Food and Drug 
Administration (FDA) for use in maintenance and detoxification 
treatment without registering as an opioid treatment program (OTP). 
Buprenorphine is a schedule III controlled substance under the CSA. To 
qualify to treat any patients with buprenorphine, the practitioner must 
be a physician, possess a valid license to practice medicine, be a 
registrant of the Drug Enforcement Administration (DEA), have the 
capacity to refer patients for appropriate counseling and other 
necessary ancillary services, and have completed required training.
    The CSA also imposes a limit on the number of patients a 
practitioner may treat with certain types of FDA-approved narcotic 
drugs, such as buprenorphine, at any one time. Specifically, Section 
303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an 
initial notification of intent (NOI) to treat a maximum of 30 patients 
at a time. After 1 year, the practitioner may file a second NOI 
indicating his/her intent to treat up to 100 patients at a time.
    Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is 
authorized to change the patient limit by regulation.

A. Regulatory History

    On March 30, 2016, the Department of Health and Human Services 
(HHS) issued a Notice of Proposed Rulemaking (NPRM), entitled, 
``Medication Assisted Treatment for Opioid Use Disorders'', in the 
Federal Register, and invited comment on the proposed rule.\1\ The 
comment period ended on May 31, 2016. In total, HHS received 498 
comments on the proposed rule. Comments came from a wide variety of 
stakeholders, including, but not limited to: Individuals that currently 
prescribe buprenorphine and other health care professionals, such as 
nurse practitioners and pharmacists; health care policymakers; national 
organizations representing providers and public health agencies; and 
individuals who self-identified as current buprenorphine patients. A 
significant number of comments came from individuals who were part of a 
mass mail campaign organized by a national organization representing 
substance use disorder treatment specialists.
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    \1\ 81 FR 17639 (Mar. 30, 2016).
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B. Overview of Final Rule

    The final rule adopts the same basic structure and framework as the 
proposed rule: Subpart A sets forth the general provisions of the rule; 
current subparts A, B, and C would change to subparts B, C, and D, 
respectively; the titles of these subparts would be revised to make it 
clear that they apply only to OTPs; subpart E is reserved and subpart F 
contains the final rule. Subpart A, Sec.  8.1 details the scope of the 
rule and explains that the proposed rules in the new subpart F pertain 
only to those practitioners using a waiver under 21 U.S.C. 823(g)(2) 
with a patient limit of 101 to 275. Subpart A, Sec.  8.2 provides the 
definitions that apply to the entirety of part 8 and Sec.  8.3 
discusses opioid treatment programs. Subpart F discusses the 
authorization to increase the patient limit to 275 patients. Subpart F, 
Sec.  8.610 describes which practitioners are qualified for a patient 
limit of 275; subpart F, Sec.  8.615 describes a qualified practice 
setting; subpart F, Sec.  8.620 discusses the process to request a 
patient limit of 275; subpart F, Sec.  8.625 details how a request will 
be processed; subpart F, Sec.  8.630 describes what a practitioner must 
do to maintain the 275 patient limit; subpart F, Sec.  8.635 is 
reserved; subpart F, Sec.  8.640 details the renewal process for 
practitioners who desire to keep their 275 patient limit; subpart F, 
Sec.  8.645 discusses the responsibilities of practitioners whose 
renewal request for the 275 patient limit was denied or who did not 
request for a renewal of the 275 patient limit; subpart F, Sec.  8.650 
details the conditions under which SAMHSA can suspend or revoke a 
patient limit increase approval; and subpart F, Sec.  8.655 provides 
the rules applicable to patient limit increases in emergency 
situations.
    HHS has made some changes to the proposed rule's provisions, based 
on the comments we received. Among the significant changes are the 
following.
    HHS has changed the highest patient limit from 200 to 275.
    HHS also changed Sec.  8.610 by revising the language in this 
section. This change will allow additional addiction specialists to 
treat up to 275 patients by including all practitioners with additional 
credentialing as defined in Sec.  8.2.
    HHS has decided to delay the finalization of the proposed reporting 
requirements in Sec.  8.635 and is publishing elsewhere in this issue 
of the Federal Register a Supplemental Notice of Proposed Rulemaking to 
solicit additional comments on the proposed reporting requirements 
prior to finalizing them. We expect to finalize the reporting 
requirements expeditiously.
    HHS has responded to the comments received on the proposed rule, 
and provided an explanation of each of the

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changes made to the proposed rule in the preamble.

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

A. General Comments

    HHS received a number of comments that expressed general support 
and advocacy for the proposed rule. Many of these comments pointed to 
the lives that will be saved and the long waitlists for MAT that will 
be shortened. Commenters also noted that the rule provides parity with 
other conditions/medications and that the rule will help provide a 
research-based understanding of addiction.
    There were also some comments that expressed disagreement with the 
proposed rule. These commenters said that MAT was not as effective as 
traditional models and that buprenorphine is a drug of diversion and 
misuse, and could result in poor outcomes. Some commenters cited a need 
for more providers rather than higher prescribing limits. Several 
commenters suggested that the application and renewal procedure and the 
recordkeeping and reporting requirements will dissuade physicians from 
applying for the higher patient limit.
    A comment also suggested that very few additional patients will 
receive addiction treatment with buprenorphine as a result of the 
proposed rule, due to the small number of subspecialists eligible to 
treat an additional 100 patients each, unclear criteria for what 
constitutes a qualified practice setting, and continued poor 
reimbursement.
    Given the evidence supporting buprenorphine-based MAT as an 
effective treatment for opioid use disorder and the magnitude of the 
opioid crisis, this rule is intended to increase access to 
buprenorphine-based MAT, prevent diversion, and ensure quality services 
are provided. With respect to the comment specifically related to the 
issues of subspecialty board certification and unclear criteria for a 
qualified practice setting, the final rule addresses these issues by 
replacing the ``board certification'' definition with an ``additional 
credentialing'' definition and also provides further clarity regarding 
the criteria for a qualified practice setting. HHS appreciates that 
increasing the patient limit for certain MAT providers is a complex 
issue and is not the only avenue for addressing the opioid public 
health crisis. HHS is promoting access to all forms of MAT for opioid 
use disorder through multiple activities included in the Secretary's 
Opioid Initiative. Given the Secretary's authority to increase the 
patient limit on treatment under 21 U.S.C. 823(g)(2) by rulemaking, the 
rule is an essential element of a comprehensive approach to increasing 
access to MAT.
    HHS also received a wide variety of comments related to the issue 
of MAT that did not specifically relate to a section of the proposed 
rule, but generally fell into five main categories. The categories and 
comments are as follows.
Other Practitioners
    Many commenters wrote about the eligibility and role of nurse 
practitioners and/or physician assistants in prescribing buprenorphine. 
The vast majority of these commenters suggested that nurse 
practitioners and physician assistants should be allowed to prescribe 
buprenorphine under the new regulation. Two major associations wrote in 
support of registered nurses with addiction specialty training to be 
able to prescribe. Numerous comments stated that HHS needed to include 
other practitioners especially in order to reach rural and medically 
underserved regions.
    HHS also received several comments opposed to allowing nurse 
practitioners and physician assistants to prescribe buprenorphine.
    Questions related to expanding eligible prescribers are outside the 
scope of this rulemaking; the statute limits who is eligible to 
prescribe buprenorphine for MAT. 21 U.S.C. 823(g)(2) limits the 
practitioners eligible for waiver in this context to physicians, and, 
therefore, HHS is not authorized to include other types of providers in 
this rule. However, HHS recognizes the issues raised by commenters and 
the President's FY 2017 Budget proposes a buprenorphine demonstration 
program to allow advance practice providers to prescribe buprenorphine. 
This would allow HHS to begin testing other ways to improve access to 
buprenorphine throughout the country.
New Formulations
    In the NPRM, HHS proposed that the Secretary would establish a 
process by which patients who are treated with medications covered 
under 21 U.S.C. 823(g)(2)(C), that have features that enhance safety or 
reduce diversion, as determined by the Secretary, may be counted 
differently toward the prescribing limit established in the proposed 
rule. Such medications are referred to here as ``new formulations.'' 
HHS also proposed that the criteria for determining which if any of 
these new formulations may be considered, and how these patients will 
be counted toward the patient limit, will be based on the following 
principles: (a) The relative risk of diversion associated with 
medications that become covered under 21 U.S.C. 823(g)(2)(C) after the 
effective date of the proposed rule; and (b) the time required to 
monitor patient safety, assure medication compliance and effectiveness, 
and deliver or coordinate behavioral health services.
    HHS did not receive any comments that provided specific criteria to 
be used to count new formulations differently under the patient limit. 
One commenter suggested that abuse-deterrent labeling should not be a 
requirement. HHS did receive a small number of comments about new 
formulations which recommended that patients being treated with these 
new formulations not be counted against a patient limit. One commenter 
stated that HHS should establish a process for counting the patients 
differently if there is a risk to public health. Another commenter 
recommended the establishment of a process for evaluating new 
formulations that would be triggered by a petition from a product 
manufacturer, trade association, practitioner, State or local agency, 
or representatives of opioid use disorder patients or their families.
    HHS received a number of comments recommending a cautious approach, 
including one suggestion to not count patients as fractions and another 
to consider the potential impact of a formulation-based counting 
methodology on practitioners and patient-driven recovery. One commenter 
expressed concern that new formulations that require less oversight 
from a practitioner may result in the reduction of psychosocial and 
other support services. HHS also received a comment that it is too soon 
to determine how patients treated with the new formulations should be 
counted.
    HHS will review new formulations as they are approved by FDA for 
use in the treatment of opioid use disorder and is strongly supportive 
of innovative formulations that increase access to MAT.
    With respect to the comments suggesting that no limit apply to 
patients treated with new formulations, HHS does not believe that 
raising the limit beyond that specified in this rule is warranted at 
this time.
    After reviewing the comments, HHS has determined under the final 
rule, all patients treated with medications covered under 21 U.S.C. 
823(g)(2)(C), including new formulations, will be counted against the 
patient limit established by this rule in the same

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manner. HHS may choose to revisit this issue in the future.
Patient Cost and Coverage
    HHS received several comments describing insurance-related issues 
that commenters believe affect access to treatment with buprenorphine. 
These comments, which are outside the scope of this rulemaking, focused 
on topics such as varying formats for requesting approval for treatment 
services and prescription coverage, reimbursement rates, coverage 
criteria, pharmacy practices, implementation of substance use disorder 
parity laws, and use of quality metrics. HHS received comments stating 
that the proposed rule does not address the many reasons why providers 
are not prescribing MAT to the fullest extent of their current waivers, 
including concerns about public and private insurer reimbursement for 
the additional reporting, documentation, and counseling as well as 
concerns about on-site DEA inspections.
    HHS appreciates these comments and is aware of the issues 
associated with access to buprenorphine. However, these issues are 
beyond the scope of this rulemaking given HHS' regulatory authority 
under 21 U.S.C. 823(g)(2)(B)(iii).
Prescribing Practices
    HHS received many comments that related to prescribing practices. 
One comment recommended that a prescriber of buprenorphine not be 
permitted to make a diagnosis of opioid use disorder or dependency in 
order to prevent the development of ``pill mills.'' Another comment 
stated that Vivitrol[supreg] should be offered along with buprenorphine 
and another stated that it should be prescribed in place of 
buprenorphine.
    Several commenters focused on limiting prescriptions of opioids. 
Others proposed limiting the allowable dosing of buprenorphine. One 
commenter recommended that the number of patients allowed for treatment 
by a waivered practitioner should be tied to the recommended dose in 
order to incentivize physicians to prescribe appropriate doses of 
buprenorphine in an effort to decrease diversion. The commenter also 
stated that a physician treating 200 patients should not be allowed to 
prescribe more than an average of 2,800 mg of buprenorphine per day. 
HHS also received a comment that practitioners prescribing 
buprenorphine up to a higher patient limit should be required to see 
patients at least once a month.
    HHS received a comment recommending that physicians obtain a 
written agreement from each patient stating that the patient: Will 
receive an initial assessment and treatment plan; will be subject to 
medication adherence and substance use monitoring; and understands all 
available treatment options, including all FDA-approved drugs for 
treatment of opioid use disorder and their potential risks and 
benefits. One commenter suggested that HHS issue firm recommendations 
on safe medication renewal quantities and weaning and reduction 
timeframes. Another commenter suggested taking into consideration the 
individual's age, gender, ethnicity, and culture during treatment.
    HHS recognizes that there are multiple approaches to addressing 
opioid use disorder. However, many of these issues are beyond the scope 
of this rule.
Other Approaches to Opioid Use Disorders
    Many comments provided suggestions on how to broadly address the 
problem of opioid use disorder. HHS received several comments noting 
that, despite being able to prescribe buprenorphine to only a limited 
number of patients, practitioners are not subject to any limits when 
prescribing opioids for pain. Some commenters recommended that either 
the limit to prescribe buprenorphine be removed or that an opioid 
prescribing limit be established. One commenter asked that if HHS 
believes that there should be a limit on the number of patients treated 
with buprenorphine, why HHS is not also seeking a limit on the number 
of patients prescribed schedule II opioids for chronic pain. And 
another commenter suggested that physicians who prescribe opioids 
should be required to offer treatment for opioid use disorders.
    HHS also received a few comments that concerned treatment using 
antidepressants, anxiolytics, and antipsychotics where patient limits 
do not apply. The commenters felt the same concept should be applied to 
buprenorphine.
    A buprenorphine patient limit was introduced in statute. HHS' 
rulemaking is intended to implement the statutory provisions. With 
respect to opioid prescribing, the Centers for Disease Control and 
Prevention (CDC) recently released the Guideline for Prescribing 
Opioids for Chronic Pain and SAMHSA supports the Providers' Clinical 
Support System-Opioid program, which is a national training and 
mentoring project that makes available at no cost continuing medical 
education (CME) programs on the safe and effective use of opioids for 
treatment of chronic pain and safe and effective treatment of opioid 
use disorder. HHS received comments focused on the system of treatment 
for opioid use disorders, including the integration of behavioral 
health into primary care; screening for substance use disorders and 
connecting to treatment via Screening, Brief Intervention, and Referral 
to Treatment (SBIRT); reimbursement issues; and use of opioid 
antagonists such as naloxone in preventing opioid overdose.
    A comment stated that the organization wanted to make sure patients 
receive long-term evidence-based care to treat opioid use disorder. HHS 
also received several comments stating that it needed to ensure that a 
full continuum of care is available for patients. While ongoing work is 
occurring throughout HHS on improving access to treatment, these 
specific issues are outside the scope of this rulemaking.
    HHS also received a comment recommending that we consider 
additional strategies to incentivize primary care providers to apply 
for waivers to prescribe buprenorphine, including educational campaigns 
to address any misperceptions related to buprenorphine prescribing and 
DEA audits, greater dissemination of research and data regarding 
evidence-based MAT, and continual engagement with stakeholders to 
ensure the legal and regulatory framework is appropriate and effective. 
Another commenter also expressed the need for a national educational 
campaign about misuse of prescription opioid analgesics. One commenter 
recommended that HHS work with other local, State and Federal entities, 
including the Centers for Medicare & Medicaid Services (CMS), FDA, CDC, 
and DEA to develop education for the public that is both comprehensive 
and targeted to address the knowledge gaps of relevant stakeholders. 
HHS received comments expressing the importance of increasing the 
number of resources, training, and qualified personnel to prescribe 
buprenorphine and administer and monitor patients. Another commenter 
also felt that we should consider additional measures to educate 
physicians about best practices to minimize the risk of diversion, 
including the distribution of best practice guidance documents. An 
additional comment expressed concerns that clinics owned and operated 
by non-physicians, or employing part-time newly waivered physicians, 
with no full-time addiction physician oversight

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and supervision will greatly increase the potential for diversion. HHS 
intends to continue to work to educate eligible practitioners about the 
waiver process and ensure that the process is as efficient as possible.
    HHS also received a comment expressing concerns that raising the 
limit will not sufficiently address improving access to individuals 
located in geographic regions where buprenorphine or other MAT 
medications are currently unavailable, because only a third of 
buprenorphine-waivered physicians are qualified to treat 100 patients 
at a time.
    HHS shares the commenters' concern that some populations are 
geographically disadvantaged in terms of access to MAT. HHS believes 
this final rule will help address this concern by expanding the ability 
for physicians in all areas, including rural areas, to treat patients 
with opioid use disorder while minimizing the risk of diversion. In 
addition, the shift in policy from allowing a practitioner with a 
waiver to treat up to 200 patients in the NPRM to allowing a 
practitioner with a waiver to treat up to 275 patients is likely to 
have a significant impact in rural areas which are currently served by 
smaller numbers of practitioners with waivers.
    HHS appreciates the many comments aiming to more broadly address 
the issue of opioid use. While this rule is more limited in scope, HHS 
is working to address some of the ideas expressed in the comments 
through other actions taken to implement the Secretary's Opioid 
Initiative.
Other Comments
    HHS received several comments estimating the number of 
practitioners who would seek a waiver for the higher patient limit. For 
example, one comment stated that between 8 and 15 Vermont physicians 
would seek the additional waiver to treat 200 patients, noting that it 
would have the potential to increase access to office-based outpatient 
treatment services by between 25 and 50 percent from its current 
utilization rate. HHS considered these estimates as it calculated the 
Regulatory Impact Analysis (RIA) for the rule.
    HHS received a comment asking why there were different rules for 
methadone and another one that asked why the rules were different than 
the rules in Canada.
    Methadone is not included as part of this rule because methadone is 
a Schedule II drug, while the only medications covered under this rule 
are in Schedule III, IV, or V, pursuant to 21 U.S.C. 823(g)(2)(C). In 
addition, the United States and Canada regulate opioid use disorder 
treatment under different laws.
    HHS received a comment stating that impaired decision-making, 
especially for safety sensitive professions (e.g., airline pilots, 
transit workers, health care professionals), posed public/patient 
safety concerns due to possible cognitive and motor impairment related 
to buprenorphine and stated that naltrexone may be considered as an 
alternative.
    While this issue is beyond the scope of this rule, HHS encourages 
all practitioners to fully inform their patients about MAT, whether it 
is appropriate for an individual patient and, if so, which FDA-approved 
medications may be most appropriate for that patient.
    Another commenter requested guidance on what constitutes an 
appropriate course of treatment and how ``recovery'' should be 
determined, which will enable them to meet the reporting requirements 
more successfully. An additional commenter requested that guidance 
specify whether or not an in-office induction is required.
    HHS appreciates these comments and will bear them in mind as it 
develops guidance documents after the final rule goes into effect.
Subpart A--General Provisions
    In the proposed rule, HHS proposed increasing the highest available 
patient limit for qualified practitioners to receive a waiver from 100 
to 200. This proposed higher patient limit was intended to 
significantly increase patient capacity for practitioners qualified to 
prescribe at this level while also ensuring that waivered practitioners 
would be able to provide comprehensive treatment associated with MAT.
    Under the final rule, practitioners authorized to treat up to 275 
patients will be required to meet infrastructure requirements that 
exceed those required for practitioners who have a waiver to treat 100 
or fewer patients. HHS proposed additional criteria and 
responsibilities for practitioners to be able to treat up to the higher 
patient limit with the specific aims of ensuring quality of care and 
minimizing diversion. Importantly, the additional criteria and 
responsibilities were not intended to be unduly burdensome to 
practitioners who wish to expand their MAT treatment practice. Also, 
the rule does not add these additional requirements to practitioners 
who have a waiver to treat up to 100 patients under 21 U.S.C. 
823(g)(2). The rule also creates an option for an increased patient 
limit for practitioners responding to emergency situations that require 
immediate, increased access to medications covered under 21 U.S.C. 
823(g)(2)(C). In addition, HHS included key definitions that will help 
practitioners understand and implement the requirements of this rule.
    As proposed in the NPRM, this rule will be added to 42 CFR part 8 
as subpart F. Accordingly, changes to part 8 were necessary to 
integrate the contents of the new regulations established by this rule 
into part 8. For example, part 8, subparts A, B, and C, had to be 
reordered as subparts B, C, and D, respectively. The titles of these 
subparts were revised to make it clear that they apply only to OTPs.
    The comments and HHS' responses are set forth below.
    Comment: HHS received several comments stating that raising the 
patient limit to 200 was not likely to make a significant impact on 
addressing the treatment gap. Some commenters suggested the limit 
should be raised to 500 patients or that there should be no patient 
limit at all. Other commenters supported the proposed limit of 200 
patients. One commenter suggested that the patient limit be removed for 
physicians operating in a nationally accredited or State licensed 
substance use disorder treatment center.
    Response: In the NPRM, HHS proposed raising the patient limit for 
certain qualified physicians to 200. This was based on a conservative 
estimate of the number of patients who could be treated by a single 
physician in a high-quality, evidence-based manner that minimizes the 
risk of diversion. However, prior to the NPRM, the proposed patient 
limit of 200 did not have the benefit of public comment. Although many 
commenters expressed that a 200 patient limit was appropriate, a number 
of commenters stated that the 200 patient limit was not sufficient to 
substantially address the treatment gap, with some commenters 
suggesting the limit be raised to 500 and others stating there should 
be no patient limit. HHS reviewed all pertinent comments and completed 
a reassessment of the available data. In particular, an analysis of the 
number of patients treated in OTPs--a set of structured clinics that 
deliver comprehensive care for opioid use disorder--helped to guide 
HHS' deliberation. Using data from the 2013 National Survey of 
Substance Abuse Treatment Services, the average number of patients who 
could be managed at any given time in an OTP ranged from 262 to 334, 
demonstrating that high-quality, evidence-based MAT could be provided 
to a larger number of patients

[[Page 44716]]

in this structured and regulated environment. Given that HHS expects 
that buprenorphine provision in the outpatient setting will involve a 
less structured and regulated environment, we believe setting the limit 
within the lower range of the average number of patients who could be 
treated in an OTP is prudent. Thus, based on our reassessment of the 
data and review of public comments, HHS has determined that increasing 
the patient limit to 275 balances the pressing need to expand access to 
MAT with the desire to ensure the provision of high-quality, evidence-
based MAT while limiting the risk of diversion. We note that this rule 
is intended to expand access directly by increasing patient capacity 
for practitioners who get a waiver to treat more than 100 patients, and 
indirectly by increasing the incentive to enter into the field of 
addiction medicine or addiction psychiatry by expanding opportunities 
within the field.
    Comment: HHS received a comment requesting that the rule provide 
some waiver increase for all certified office-based opioid treatment 
with buprenorphine physicians. The commenter also recommended that all 
physicians currently holding a waiver to prescribe up to 100 patients 
and who have been in good standing for the past year be allowed 
increases as follows: (1) If they are not board certified and not 
working in a qualified practice setting, they should be allowed to 
treat an additional 50 patients; (2) If they are not board certified 
but are working in a qualified practice setting, they should be allowed 
to treat an additional 100 patients; (3) If they are board certified 
but not working in a qualified practice setting, they should be allowed 
to treat an additional 150 patients; and (4) If they are board 
certified and are working in a qualified practice setting, they should 
be allowed to treat an additional 200 patients.
    Response: The rule seeks to balance the increased accountability 
associated with the higher limit of 275 with the opportunity for 
practitioners to attain efficiencies of scale and provide two distinct 
and non-duplicative pathways by which practitioners can access the 
higher limit. This reflects HHS' desire to provide pathways to the 
higher limit to a range of motivated practitioners, with a modest and 
tolerable burden to the practitioner.
    Comment: HHS received a comment recommending that ABAM-certified 
physicians not be limited in the number of patients to whom they can 
prescribe buprenorphine. HHS also received a comment encouraging HHS to 
lift the patient limit for any practitioner providing MAT using 
buprenorphine in all programs licensed or certified by a State 
oversight agency for substance use.
    Response: HHS appreciates the comment and the role of ABAM-
certified practitioners and has modified the proposed rule to include 
these professionals among those eligible for the highest limit of 275. 
With respect to the comments suggesting that no limit apply to patients 
treated by practitioners in programs licensed or certified by a State 
oversight agency, HHS believes, for the reasons stated, that the 275 
patient limit is the appropriate limit.
    Comment: HHS received a comment recommending that the patient limit 
be based on the percentage of the practice that provides addiction 
treatment.
    Response: Relevant patient limits in this context apply to a 
specific waivered practitioner, not to a practice of multiple 
providers. Accordingly, HHS believes that the approach taken in the 
final rule provides the best available method to clearly establish a 
higher patient limit that can be monitored and enforced.
    Comment: HHS received a comment requesting greater clarity about 
whether a patient treated with buprenorphine at an OTP is counted 
toward the practitioner's patient limit. The commenter recommended that 
patients treated in opioid treatment programs not be counted toward the 
patient limit.
    Response: Patients receiving buprenorphine administered or 
dispensed by an OTP, from medication ordered under the program's DEA 
registration, are patients of the OTP and do not count toward any 
practitioner's patient limit.

Summary of Regulatory Changes

    For the reasons set forth above and considering the comments and 
additional information received, we have changed the proposed patient 
limit of 200 to 275 patients per practitioner for practitioners who 
meet the requirements laid out in the final rule.
Subpart A--Scope (Sec.  8.1)
    HHS proposed that the scope of part 8 would cover rules that are 
applicable to OTPs, and to waivered practitioners who seek to treat 
more than 100 patients with applicable medications. New subparts B 
through D under the final rule contain the rules relevant to OTPs. 
Subpart E is reserved and Subpart F contains the new final rule. 
Section 8.1 also explains that the rules in the new subpart F pertain 
only to those practitioners using a waiver under 21 U.S.C. 823(g)(2) 
with a patient limit of 101 to 275.

Summary of Regulatory Changes

    HHS did not receive any comments on this provision. Therefore, for 
the reasons set forth in the proposed rule, we are finalizing the 
provisions as proposed in Sec.  8.1 without modification.
Subpart A--Definitions (Sec.  8.2)
    HHS proposed definitions that would apply to the entirety of part 
8. HHS also proposed revising definitions that would apply only to 
OTPs. Two definitions were proposed for elimination: ``Registered 
opioid treatment program'' and ``opiate addiction.''
    HHS proposed a revised definition of ``patient.'' At present, the 
definition of ``patient'' in Sec.  8.2 is limited to those individuals 
receiving treatment at an OTP, which excludes those individuals 
receiving office-based opioid treatment with buprenorphine, i.e., those 
practitioners subject to 21 U.S.C. 823(g)(2).
    HHS proposed a revised definition of patient to make it inclusive 
of all persons receiving MAT with an opioid medication, consistent with 
the expanded scope of proposed revisions to 42 CFR part 8. HHS proposed 
that patient ``means any individual who receives MAT from a 
practitioner or program subject to this part.'' Upon further review, we 
determined that modifications to the proposed definition of ``patient'' 
were needed to clarify the scope of patients covered under this rule 
(for purposes of the patient limit), and to distinguish such patients 
from opioid treatment program patients for which no patient limit 
applies. We are now defining patient as, for purposes of subparts B-E, 
meaning any individual who receives maintenance or detoxification 
treatment in an opioid treatment program. For purposes of subpart F 
patient means any individual who is dispensed or prescribed covered 
medications by a practitioner. The patient definition modifications 
reflected in the final rule are consistent with the intention of the 
NPRM. As we explained in the NPRM, if a practitioner, for example, 
provides cross-coverage for another practitioner and in the course of 
that coverage the covering practitioner provides a prescription for 
buprenorphine, the patient counts towards the cross-covering 
practitioner's patient limit until the prescription or medication has 
expired. However, if a cross-covering practitioner is merely available 
for consult but does not dispense or prescribe buprenorphine while the 
prescribing practitioner is away, the patients being covered do not 
count

[[Page 44717]]

towards the cross-covering practitioner's patient limit. Therefore, 
this definition is expected to help ensure consistency and clarity in 
how waivered practitioners count patients towards the patient limit.
    HHS proposed that the rule include the following definition of 
patient limit: ``the maximum number of individual patients a 
practitioner may treat at any time using covered medications.'' Given 
the changes to the definition of ``patient,'' the definition for 
``patient limit'' was modified to mean the maximum number of individual 
patients that a practitioner may dispense or prescribe covered 
medications to at any one time. This modification ensures alignment 
between the definition of ``patient'' and ``patient limit.''
    Taken together, the definitions of ``patient'' and ``patient 
limit'' provide clear and fair guidance for regulatory enforcement and 
are expected to reduce undercounting of patients by practitioners. 
These definitions are also intended to clarify that patients who are 
not dispensed or prescribed medication covered by this rule should not 
be counted against a practitioner's patient limit. Accordingly, 
waivered practitioners will be able to provide reciprocal cross-
coverage to patients of other practitioners (assuming the dispensing or 
prescribing of covered medication is not involved) for brief periods, 
such as weekends or vacations, without requiring such patients to be 
added to the patient count of the practitioner who is providing cross-
coverage.
    Other new definitions proposed include ``behavioral health 
services,'' ``emergency situation,'' ``nationally recognized evidence-
based guidelines,'' ``practitioner incapacity'' and ``waivered 
practitioner.''
    HHS proposed to define ``nationally recognized evidence-based 
guidelines'' to mean a document produced by a national or international 
medical professional association, public health entity, or governmental 
body with the aim of ensuring the appropriate use of evidence to guide 
individual diagnostic and therapeutic clinical decisions. Some examples 
include the American Society of Addiction Medicine (ASAM) National 
Practice Guidelines for the Use of Medications in the Treatment of 
Addiction Involving Opioid Use; SAMHSA's Treatment Improvement Protocol 
40: Clinical Guidelines for the Use of Buprenorphine in the Treatment 
of Opioid Addiction; the World Health Organization Guidelines for the 
Psychosocially Assisted Pharmacological Treatment of Opioid Dependence; 
the Department of Veterans Affairs/Department of Defense/Clinical 
Practice Guideline on Management of Substance Use Disorder; and the 
Federation of State Medical Boards' Model Policy on DATA 2000 and 
Treatment of Opioid Addiction in the Medical Office. HHS expects that 
guidelines meeting this definition may change over time but does not 
plan to keep a list for practitioners to consult.
    The definitions of ``practitioner'' and ``practitioner incapacity'' 
were modified to remove the term ``waivered'' since that term does not 
appear in the regulatory text. In addition, the definition of 
``certification'' was renamed ``opioid treatment program 
certification'' to clarify that the definition in Sec.  8.2 
specifically applies to certification of OTPs.
    In addition, the final rule includes a definition of Medication-
Assisted Treatment (MAT) that was provided in the preamble of the NPRM, 
but that was not inserted into the rule text of the NPRM. Accordingly, 
``Medication-Assisted Treatment'' is now defined in the text of the 
final rule.
    The final rule also replaced ``board certification'' with 
``additional credentialing'' due to the removal of the term 
``subspecialty'' with respect to practitioners that can request a 
higher limit outside of a qualified practice setting.
    The comments and our responses are set forth below.
    Comment: HHS received a small number of comments regarding the 
definition of patient as it relates to counting a patient towards the 
cross-covering practitioner's patient limit. One commenter requested 
that we develop a way for practitioners to provide coverage for other 
physicians without having to count these patients as part of their 
patient limit. Another commenter recommended that the patients served 
during cross-coverage count either toward the practitioner's patient 
limit for 30 days or the number of days' supply provided by the 
prescription, whichever is greater. Another commenter recommended that 
prescriptions for less than 30 days during cross-coverage should not 
count against the practitioner's patient limit.
    Response: HHS is aware that providing coverage in a time-limited 
manner has posed a challenge to practitioners and patients. By defining 
``patient'' for purposes of subpart F as, ``any individual who is 
dispensed or prescribed covered medications by a practitioner,'' the 
definition links the patient to the practitioner who provides the 
patient with his or her covered medications. Such patients will remain 
a patient of the prescribing practitioner for the duration of the 
prescription or for as long as the dispensed medication lasts. As noted 
above, in cases where a cross-covering practitioner does not provide a 
patient with covered medication, the patient will not count toward that 
practitioner's patient limit. In the event that the cross-covering 
practitioner dispenses or prescribes covered medication to a patient, 
the patient will only count towards the cross-covering practitioner for 
as long as the medication lasts or until the prescription expires.
    Comment: HHS received one comment requesting additional examples of 
the types of guidelines that would satisfy the requirement to use 
nationally recognized evidence-based guidelines.
    Response: HHS has added another example to the list provided in the 
preamble of the NPRM with regard to the definition of ``nationally 
recognized evidence-based guidelines.''
    Comment: HHS received a comment that suggested the establishment of 
standards of care that DATA 2000 providers must follow.
    Response: HHS requires in the rule the use of nationally recognized 
evidence-based guidelines, but declines to establish a specific 
standard of care in regulating the practice of medicine as it exceeds 
the scope of the Secretary's authority.
Summary of Regulatory Changes
    For the reasons set forth in the proposed rule and after 
considering the comments received, HHS is modifying several of the 
proposed definitions in Sec.  8.2 to enhance clarity and consistency 
with the scope of 21 U.S.C. 823(g)(2). Specifically, HHS has modified 
the definitions for ``patient'' and ``patient limit,'' and modified the 
terms ``practitioner'' and ``practitioner incapacity.'' Finally, HHS 
removed the term ``board certification'' and added ``additional 
credentialing'' to clarify that all practitioners who currently qualify 
to treat up to 100 patients are eligible for the higher patient limit 
if they are included as specialists as described in 21 U.S.C. 823 
(g)(2)(G)(ii)(I)-(III).
Subparts B, C, and D--Opioid Treatment Programs (Sec. Sec.  8.3 Through 
8.34)
    HHS proposed retitling subparts B, C, and D Sec. Sec.  8.3 through 
8.34 so as to implement the addition of subpart F. We proposed changes 
to these sections limited to changing the mailing address for program 
certification and accreditation body approval and updating terms, such 
as ``opiate'' and

[[Page 44718]]

``opiate addiction'' to ``opioid'' and ``opioid use disorder,'' 
respectively.
    The comments and our responses are set forth below.
    Comment: HHS received one comment that recommended that it develop 
result-oriented performance standards for methadone maintenance 
treatment programs (also referred to as opioid treatment programs); 
provide guidance to treatment programs regarding the type of data that 
must be collected to permit assessment of programs' performance; and 
assure increased program oversight oriented toward performance 
standards.
    Response: HHS is not addressing the performance standards for 
opioid treatment programs in this rule.
    Comment: HHS received a comment stating that the Federal government 
should be putting pressure on States to open access to care through 
OTPs in States that are more likely to prohibit opioid treatment 
programs from operating.
    Response: HHS is committed to increasing access to MAT through 
various strategies, but cannot address this specific issue through the 
final rule.
Summary of Regulatory Changes
    HHS did not receive any comments related to Sec. Sec.  8.3 through 
8.34 that were capable of being addressed in the final rule. Therefore, 
for the reasons set forth in the proposed rule, HHS is finalizing the 
provisions Sec. Sec.  8.3 through 8.34 without modification.
Subpart F--Which Practitioners Are Eligible for a Patient Limit of 275 
(Sec.  8.610)
    Proposed Sec.  8.610 described how practitioners can qualify for 
the 200 patient limit. Such practitioners would be required to possess 
subspecialty board certification in addiction medicine or addiction 
psychiatry or practice in a qualified practice setting as defined in 
the rule. In either case, practitioners with the higher limit would 
have to possess a waiver to treat 100 patients for at least 1 year in 
order to gain experience treating at the higher limit. The purpose of 
offering the 200 patient limit to practitioners in these two categories 
was to recognize the benefit offered to patients by either: (1) The 
advanced training, knowledge, and skill of practitioners with a 
subspecialty board certification; or (2) the higher level of direct 
service provision and care coordination envisioned in the qualified 
practice setting. This approach would restrict access to the 200 
patient limit to a subset of the practitioners waivered to provide care 
up to 100 patients. In addition to ensuring higher quality of care, the 
criteria for the higher limit would be intended to minimize the risk of 
diversion of controlled substances to illicit use and accidental 
exposure that could result from increased prescribing of buprenorphine. 
A practitioner with board certification in an addiction subspecialty 
would have to have the training and experience necessary to recognize 
and address behaviors associated with increased risk of diversion. In 
the qualified practice settings, HHS believes that the care team and 
practice systems will function to help ensure this same level of care. 
HHS requested comments on this proposed approach, including comments on 
whether there are other ways for HHS to ensure quality and safety while 
encouraging practitioners to take on additional patients.
    The comments and HHS responses are set forth below.
    Comment: HHS received numerous comments expressing concerns about 
the restrictive nature of the requirement to obtain subspecialty board 
certification in order to reach the higher patient limit.
    Response: HHS has revised the language from Sec.  8.610(b)(1), 
allowing practitioners who possess additional credentialing as defined 
in Sec.  8.2 to become eligible for the higher, 275-patient limit. HHS 
believes that this new requirement balances the need to maintain a 
qualified workforce while having realistic expectations that do not 
prohibit capable practitioners from increasing their patient limits.
    Comment: One comment expressed concerns that the rule will create a 
two-tiered system resulting in patients with the same diagnosis 
receiving markedly different quality and intensity of services, and 
recommended that we create a continuum of care whereby all patients 
with the same diagnosis receive equally high quality, evidence-based 
care.
    Response: HHS disagrees that the rule creates a two-tiered system. 
Rather, it extends and enhances the system that currently exists in an 
effort to improve access to treatment for those with opioid use 
disorders.
    Comment: HHS received a comment recommending that we implement an 
accreditation initiative for qualified practitioners seeking to 
increase the number of patients for whom they prescribe buprenorphine.
    Response: HHS does not believe this approach is warranted at this 
time.
    Comment: HHS received a comment stating that all physicians who 
currently have credentials provided by one of the following 
professional organizations be eligible to request the increased patient 
limit: (1) ABAM; (2) ASAM; (3) American Board of Psychiatry and 
Neurology (ABPN); and (4) American Osteopathic Association. Another 
commenter recommended that HHS allow osteopathic physicians who are 
also boarded in other areas to be board-certified in addiction 
medicine.
    Response: HHS has revised the language from Sec.  8.610(b)(1), 
allowing practitioners who possess additional credentialing as defined 
in Sec.  8.2 to become eligible for the higher, 275-patient limit. 
However, given the significant responsibility associated with 
prescribing buprenorphine, HHS believes that practitioners should 
additional credentialing as defined in Sec.  8.2 to safely and 
appropriately provide treatment up to 275 patients outside of a 
qualified practice setting. Therefore, HHS declines to incorporate some 
of the proposed approaches into the rule.
    Comment: HHS received a small number of comments requesting a 
grandfathering clause for physicians who are currently working full 
time in the addiction field and who have missed the option to become 
board certified without doing a fellowship by the change in the 
availability of the ABAM exam.
    Response: Given the significant responsibility associated with 
prescribing buprenorphine, HHS believes that practitioners should have 
additional credentialing as defined in Sec.  8.2.
    Comment: HHS received a comment recommending that physicians who 
have been recognized by SAMHSA for their Science and Service to their 
office-based treatment patients should be given priority when applying 
for the increased patient limit.
    Response: Given the significant responsibility associated with 
prescribing the applicable medications covered under the final rule, 
HHS believes that practitioners should have additional credentialing as 
defined in Sec.  8.2 or practice in a qualified practice setting to 
safely and appropriately provide treatment to up to 275 patients. We 
believe most, if not all, of these practitioners will meet these 
requirements. Therefore, HHS declines to incorporate this approach into 
the rule.
    Comment: HHS received a comment recommending that OTP licensure be 
the only pathway to creating addiction treatment programs that treat 
more than 100 patients.
    Response: HHS believes that the pathways outlined in the final rule 
provide appropriate pathways through which practitioners can become 
eligible to prescribe buprenorphine to up to 275

[[Page 44719]]

patients, while taking into account quality care and risk of diversion. 
Given OTP capacities and other regulatory requirements, limiting access 
to treating up to 275 patients to OTPs would reduce the ability to 
increase access to care in as meaningful a way as can be accomplished 
through the pathways included in the final rule.
    Comment: HHS received several comments recommending an alternate 
pathway for non-specialists in addiction medicine, which would require 
them to complete an additional 36 hours of addiction-related CME every 
three years. HHS received another comment proposing an alternate 
pathway that includes 24 hours of training, with Naloxone education as 
a part of that training.
    Response: HHS has revised the language from Sec.  8.610(b)(1), 
allowing practitioners who possess additional credentialing as defined 
in Sec.  8.2 to become eligible for the higher, 275-patient limit. 
However, given the significant responsibility associated with 
prescribing buprenorphine, HHS believes that practitioners should have 
additional credentialing as defined in Sec.  8.2 to safely and 
appropriately provide treatment to up to 275 patients outside of a 
qualified practice setting. Therefore, HHS has declined to incorporate 
this approach into the rule.
    Comment: HHS received a comment suggesting that an alternate 
pathway be considered on a case by case basis in highly rural areas 
where practitioners may not be board certified or part of a qualified 
practice setting. The commenter recommended that providers who request 
the higher patient limit in these settings be required to have a mentor 
with extensive expertise and with whom they have regular consultation.
    Response: Given the significant responsibility associated with 
prescribing buprenorphine, HHS believes that practitioners should be 
board certified or practicing in a qualified practice setting to safely 
and appropriately provide this treatment to up to 275 patients. 
Therefore, HHS has declined to incorporate this approach into the rule.
    Comment: HHS received a comment that it should not raise the 
patient limit for any practitioner who has not completed an accredited 
fellowship or residency in addiction medicine.
    Response: HHS believes that the pathways outlined in the final rule 
provide appropriate pathways through which practitioners can become 
eligible to prescribe buprenorphine to up to 275 patients, while taking 
into account quality care and risk of diversion. Limiting access to 
treating up to 275 patients to practitioners who have completed 
accredited fellowships or residencies in addiction medicine would 
reduce the ability to increase access to care in as meaningful a way as 
can be accomplished through the pathways included in the final rule. 
Therefore, HHS has declined to incorporate this approach into the rule.
    Comment: HHS received a comment recommending that, in addition to 
providing current pathways to become eligible for the higher patient 
limit, HHS reserve the authority to identify any additional criteria 
that could make a practitioner qualified to apply for the higher limit.
    Response: HHS retains this authority.
    Comment: HHS received a few comments about the length of time it 
takes for practitioners to qualify to treat the higher patient limit. 
These comments noted that it will take two years for new practitioners 
to become eligible to prescribe buprenorphine to the higher patient 
limit and some suggested creating a faster pathway.
    Response: In more than doubling the patient limit as a result of 
the final rule for certain practitioners with a 100 patient limit, HHS 
believes it is critical to ensure that practitioners who obtain the 
higher patient limit have at least one year of experience prescribing 
at the current highest patient limit. Practitioners who have had a 
waiver to treat up to 100 patients for at least a year will be eligible 
to apply for the higher limit immediately.
Summary of Regulatory Changes
    For the reasons set forth in the proposed rule and considering the 
comments received, HHS replaced ``board certification'' with 
``additional credentialing'' in Sec.  8.2 which will allow additional 
practitioners to become eligible for the 275-patient limit. At the 
beginning of Sec.  8.610, we replaced the text that states that ``A 
practitioner is eligible for a patient limit of 200,'' with language 
that states the total number of patients that a practitioner may 
dispense or prescribe covered medications to at any one time for 
purposes of 21 U.S.C. 823(g)(2)(B)(iii) is 275. Other than increasing 
the applicable patient limit to 275 (the basis for which has been 
discussed elsewhere in this preamble) the modified language does not 
reflect an intention to substantively change any other aspect of the 
patient limit from that which was proposed in the NPRM. Rather, the 
language modification is intended to align the final rule's text with 
the terminology used in 21 U.S.C. 823(g)(2)(B)(iii).
Subpart F--Qualified Practice Setting (Sec.  8.615)
    HHS proposed Sec.  8.615 to describe the necessary elements of a 
qualified practice setting, which can include practices with as few as 
one waivered provider as long as these criteria are met, and can 
include both private practices and community-based clinics. Necessary 
elements of a qualified practice setting would include: (1) The ability 
to offer patients professional coverage for medical emergencies during 
hours when the practitioner's practice is closed; this does not need to 
involve another waivered practitioner, only that coverage be available 
for patients experiencing an emergency even when the office is closed; 
(2) the ability to ensure access to patient case-management services 
including behavioral health services; (3) health information technology 
(health IT) systems such as electronic health records, when 
practitioners are required to use it in the practice setting in which 
he or she practices; (4) participation in a prescription drug 
monitoring program (PDMP), where operational, and in accordance with 
State law. PDMP means a statewide electronic database that collects 
designated data on substances dispensed in the State. For practitioners 
providing care in their capacity as employees or contractors of a 
Federal government agency, participation in a PDMP would be required 
only when such participation is not restricted based on State law or 
regulation based on their State of licensure and is in accordance with 
Federal statutes and regulations; and (5) employment, or a contractual 
obligation to treat patients in a setting that has the ability to 
accept third-party payment for costs in providing health services, 
including written billing, credit and collection policies and 
procedures, or Federal health benefits.
    The elements were identified as common to many high-quality 
practice settings, which includes both private practices as well as 
federally qualified health centers and community mental health centers, 
and therefore worthy of replication. The elements would be expected to 
be common to OTPs, and OTPs currently in operation but not providing 
MAT under 21 U.S.C. 823(g)(2). Taken together, this would facilitate 
additional opportunities to expand access to MAT. Another consideration 
in the selection of these elements was the need to limit the expansion 
of group practices formed for the sole purpose of pooling the 
individual practitioner limits to maximize revenue but which fail to

[[Page 44720]]

offer a full continuum of services. HHS sought comment on additional, 
alternate pathways by which a practitioner could become eligible to 
apply for a higher patient limit.
    The comments and HHS responses are set forth below.
    Comment: HHS received a small number of comments expressing 
concerns that a qualified practice setting does not include a mandate 
to have trained substance use disorder counseling staff on site or 
available by an affiliation agreement. One commenter also recommended 
requiring a set ratio of addiction counselors in qualified practice 
settings. HHS also received a small number of comments recommending 
that HHS implement a requirement that provides for waivered 
practitioners to hire behavioral health providers as part of their 
practice or have a formalized agreement with outside providers to offer 
these services.
    Response: HHS has carefully considered the required elements of a 
qualified practice setting and has balanced the benefits of ensuring 
quality services and preventing diversion with the costs of being too 
restrictive. A requirement to have substance use disorder counseling or 
other behavioral health providers on staff on site or available by an 
affiliation agreement could limit the number of entities that would 
meet the requirements of a qualified practice setting and therefore not 
sufficiently increase access to treatment. A specific set ratio of 
addiction counselors in a qualified practice setting may also restrict 
the number of entities which would meet the definition of qualified 
practice setting and limit the impact of the rule.
    Comment: HHS received a small number of comments noting that the 
narrow definition of a qualified practice setting makes it difficult 
for rural physicians or physicians in underserved settings to meet 
these qualifications.
    Response: HHS believes that entities such as federally qualified 
health centers, community mental health centers, OTPs, and certain 
private practices which exist in rural and other underserved areas can 
meet the definition of a qualified practice setting.
    Comment: One comment recommended that HHS require third-party 
accreditation for qualified practice settings via the Commission on 
Accreditation of Rehabilitation Facilities (CARF) or the Joint 
Commission on Accreditation of Health Care Organizations (JCAHO).
    Response: Requiring accreditation of qualified practice settings 
could create a barrier for individual practitioners who have a waiver 
to prescribe buprenorphine and have an interest in applying for the 
higher patient limit. HHS believes the burden imposed on these 
practitioners would be unreasonable and is not justified. Accordingly, 
HHS has not made any changes to the rule based on this comment.
    Comment: One commenter also encouraged pharmacists to enter into 
collaborative practice agreements with physicians and other prescribers 
as part of a qualified practice setting.
    Response: HHS encourages collaborative relationships between 
physicians and pharmacists, but declines to require it as a specific 
requirement as part of the definition of qualified practice setting.
    Comment: HHS received a comment suggesting that skilled nursing 
homes and long-term residency facilities be added to the list of 
settings in which buprenorphine induction and maintenance can occur.
    Response: Any facility that meets the requirements of a qualified 
practice setting will be considered a qualified practice setting.
    Comment: One commenter suggested any medical facility offering MAT 
should offer both buprenorphine and Vivitrol[supreg].
    Response: HHS supports the full array of services, including 
medications, that comprise evidence-based MAT, but this requirement is 
beyond its scope.
    Comment: HHS received a comment expressing concerns that the rule 
will consolidate the use of medication in large treatment centers, 
which will lead to increased prices for patients.
    Response: HHS expects that the practitioners who obtain a waiver to 
prescribe to up to 275 patients as well as additional practitioners who 
decide to obtain a waiver for 30 or 100 patients either in an effort to 
eventually obtain a 275 patient limit or because they feel more 
confident that treatment capacity in the community is sufficient to 
keep them from being overwhelmed by demand, will increase access to MAT 
at both individual practices as well as among practitioners affiliated 
with treatment centers. HHS does not have information to assess how 
this will impact patient prices for care.
After-Hours Coverage
    Comment: HHS received a comment recommending that all practitioners 
who prescribe MAT should have after-hours coverage, regardless of the 
size of the practice.
    Response: Adopting the approach urged by the commenter, which would 
apply to all practitioners prescribing MAT regardless of their 
authorized patient limit, is beyond the scope of the rule.
Health Information Technology (Health IT)
    Comment: HHS received a small number of comments requesting 
clarification about what exactly constitutes a qualifying use of health 
IT. Specifically, the commenter asked whether the definition of 
``meaningful use'' under the Medicare regulations would apply, and 
whether a program specifically designed for medical use would be 
required or if a practitioner could simply maintain a spreadsheet of 
all enrolled patients.
    Response: The rule requires that practitioners use health IT like 
electronic health records or health information exchanges only if such 
records are otherwise required to be used in the practitioner's 
practice setting. The rule does not create a new requirement to use 
electronic health records.
    Comment: HHS received a comment stating that electronic health 
records are not as efficient as paper reporting.
    Response: HHS disagrees. Some of the specific benefits associated 
with electronic health records include the ability to access patient 
charts remotely, the receipt of notifications about potential medical 
errors, the receipt of important reminders about providing preventive 
care and meeting clinical guidelines, and the ability to communicate 
directly with patients. All of these benefits enable practitioners to 
make well-informed, safe, and timely treatment decisions and ultimately 
provide higher-quality care.
Prescription Drug Monitoring Programs (PDMPs)
    Comment: HHS received a small number of comments expressing 
concerns about the requirement to check PDMPs. These comments noted 
that not all States have operational PDMPs and questioned the extent to 
which PDMPs benefit patients.
    Response: HHS supports PDMPs as a tool to address opioid use 
disorders and notes that at the time of the proposed rule, there were 
49 States with operational PDMPs. The rule requires the use of a PDMP 
where a program is operational and its use is permitted/required in 
accordance with State law.
    Comment: Several comments stated that providers should be 
incentivized to use PDMPs. One commenter recommended that the final 
rule require regular review of the PDMP for patients receiving 
buprenorphine and documentation of the reviews in the patient's chart. 
Another commenter

[[Page 44721]]

suggested a mandatory review of State PDMPs on each visit to make 
certain that buprenorphine/naloxone is filled appropriately and no 
other narcotics are being prescribed.
    Response: HHS understands this comment to refer to all patients who 
may be prescribed buprenorphine. HHS appreciates these comments; but 
the suggestions fall beyond the scope of this rule.
    Comment: One comment requested that HHS provide assistance to 
States in developing and improving prescription drug monitoring 
programs.
    Response: Providing assistance to States in developing and 
improving PDMPs is outside the scope of the rule, but HHS does have 
several programs that have provided this assistance to States in the 
past and has a program at CDC that currently does so. More information 
can be found here--https://www.cdc.gov/drugoverdose/pdmp/states.html.
    Comment: One commenter stated that registration with a State 
prescription database should be a requirement for all waivered 
physicians, not just the ones with the higher limit.
    Response: Imposing requirements on practitioners treating patients 
for all waivered practitioners is beyond the scope of this rule.
Provision of Behavioral Health Services
    Comment: HHS received a comment requesting clarification about how 
a qualified practice is required to provide access to case management 
services and whether providing the phone number for other providers 
would satisfy this requirement.
    Response: The intent of the requirement is that a practitioner have 
services available on site or have a referring relationship to case 
management or counseling services that allows for warm hand-offs of the 
patient and ongoing care coordination, not just the ability to provide 
a phone number.
    Comment: HHS received numerous comments about the need for 
comprehensive psychosocial or case management treatment and team-based 
care along with buprenorphine.
    Response: HHS agrees that comprehensive behavioral support services 
are a critical component of the effective delivery of MAT, including 
buprenorphine-based MAT. The standard of care \2\ includes the 
provision of behavioral health support services and HHS encourages all 
practitioners who are authorized to prescribe buprenorphine to ensure 
that their patients receive these services.
---------------------------------------------------------------------------

    \22\ Center for Substance Abuse Treatment. Clinical Guidelines 
for the Use of Buprenorphine in the Treatment of Opioid Addiction. 
Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. 
(SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Health 
Services Administration, 2004
---------------------------------------------------------------------------

    Comment: HHS received a small number of comments in favor of 
raising the patient limit without requiring formal counseling. One 
commenter stated that many patients feel that attending less formal 
counseling that is not delivered by licensed or certified health care 
professionals such as Narcotics Anonymous meetings are 
counterproductive.
    Response: HHS believes that in order to ensure quality care, 
providing behavioral health support services is a key component to 
delivering effective MAT and encourages all practitioners prescribing 
covered medications to ensure that their patients receive it. The 
selection of behavioral health support services is a clinical decision 
to be made between the practitioner and the patient.
    Comment: HHS received a small number of comments requesting that it 
provide a clearer definition of the format of referral to behavioral 
health providers. One commenter requested that HHS issue guidance that 
clearly defines the format of referral agreements. One comment 
requested that HHS define the format of referral to behavioral health 
services to require active referring rather than just the capacity to 
refer. Similarly, another commenter recommended that providers with a 
waiver to prescribe buprenorphine be required to include a Letter of 
Agreement with an organization for counseling services.
    Response: HHS believes that limiting the referral to a specific 
format may be unduly restrictive and have unintended consequences. As 
noted earlier, HHS declines to require a specific written agreement as 
part of the behavioral health services component of the qualified 
practice setting definition, but may provide further guidance with 
respect to example referral agreements at a later date.
    Comment: HHS received a comment asking whether a peer recovery 
support specialist would be considered capable of meeting the 
requirements for providing behavioral health services.
    Response: Peer recovery support services are one possible 
behavioral health service. The selection of specific psycho-social 
interventions is a clinical decision to be made between the 
practitioner and the patient.
    Comment: HHS received a comment noting that current guidelines for 
concurrent psychosocial treatment with buprenorphine are not enforced 
and, as a result, raising the patient limit may not effectively 
increase access to care.
    Response: The enforcement of concurrent psychosocial treatment with 
buprenorphine exceeds the scope of this rule.
Third-Party Payment
    Comment: HHS received numerous comments expressing concerns with 
the requirement that practitioners prescribe in a setting that accepts 
third-party payment.
    Response: This requirement was created to minimize the public 
health and safety risks, such as diversion, that are associated with 
dispensing or prescribing medications that are not supported by an 
appropriate medical diagnosis and assessment of medical need. Such 
risks are often associated with ``cash only: entities that do not 
accept any third-party payment for services. Using third-party payment 
provides a record that buprenorphine has been provided to an individual 
and thus allows for more accountability, lowering the risk of 
diversion. However, not everyone who needs treatment has a third-party 
payer (e.g., insurance or Medicaid coverage). Thus, to avoid creating 
more barriers to treatment for these individuals, this regulation would 
not require third-party payment for all patients by practitioners 
operating at the higher patient limit and instead would only require 
that the provider be authorized and capable of billing third-party 
payers as an indication of their level of accountability. Moreover, 
with increasing coverage of substance use disorder treatment through 
private insurance and Medicaid programs in many States, substance use 
disorder treatment providers should have additional incentives to 
qualify and engage in third-party billing.
    Comment: HHS received a comment requesting clarification on whether 
a practice would need to accept all third-party payment sources, 
including Medicare and Medicaid. The commenter also asked whether a 
practitioner can require payment in cash but provide billing 
information for the patient to submit to their insurance for 
reimbursement.
    Response: Practitioners who qualify for the higher patient limit by 
practicing in a qualified practice setting must be able to accept 
third-party payments. However, the intention of the requirement is not 
that the practitioner must accept only third-party payments or must 
accept all third-party payment sources. Rather, the practitioner in a 
qualified practice setting must accept at least some third-party 
payment systems. The practitioner in a qualified practice

[[Page 44722]]

setting cannot have a ``cash only'' business.
    Comment: HHS received a comment recommending that physicians be 
incentivized to care for Medicaid patients by not counting a certain 
number of Medicaid patients towards their higher limit.
    Response: This issue is beyond the scope of this rule.
    Comment: HHS received several comments stating that the requirement 
to accept third-party payments should be expanded to include all 
individuals with the higher patient limit, not just those using the 
``qualified practice setting'' exception.
    Response: The elements of a qualified practice setting are intended 
to provide practitioners who have not qualified for the higher patient 
limit as a result of possessing additional credentialing as defined in 
Sec.  8.2 with the necessary specialty training to prevent diversion 
and provide quality services. HHS declines to incorporate this approach 
into the rule.
Diversion Control Plan
    Comment: HHS received numerous comments about the need for formal 
diversion mitigation strategies, such as wrapper counts, drug testing, 
enforcement of the parity law for treatment, and the use of more 
efficient and lower dose, dual therapy preparations.
    Response: HHS agrees that a diversion plan is important. The final 
rule requires that providers who receive the higher patient limit 
attest to having such a plan. The specifics of the diversion plan will 
be left to the individual practitioner.
    Comment: HHS received a comment recommending that physicians obtain 
a written agreement from each patient stating that the patient: Will 
receive an initial assessment and treatment plan; will be subject to 
medication adherence and substance use monitoring; and understands all 
available treatment options, including all FDA-approved drugs for 
treatment of opioid use disorder and their potential risks and 
benefits.
    Response: HHS supports the intent of the comment but these issues 
are related to provider-patient relationships and therefore beyond the 
scope of this rule.
Summary of Regulatory Changes
    For the reasons set forth in the proposed rule, and considering the 
comments received, HHS is finalizing the provisions as proposed in 
Sec.  8.615 without modification.
Subpart F--Process To Request a Higher Patient Limit of 275 (Sec.  
8.620)
    HHS proposed Sec.  8.620 to describe the process to request a 
patient limit of 200. Similar to the waiver process for the 30 and 100 
patient limits, the process would begin with filing a form, in this 
case, a Request for Patient Limit Increase. A proposed draft of the 
Request for Patient Limit Increase was posted along with the NPRM and 
has been submitted to the Office of Management and Budget for final 
review. The higher patient limit would carry with it greater 
responsibility for behavioral health services, care coordination, 
diversion control, and continuity of care in emergencies and for 
transfer of care in the event that the practitioner does not request 
renewal of the higher patient limit or the practitioner's renewal 
request is denied. The new Request for Patient Limit Increase process 
would require providers to affirm that they would meet these 
requirements. HHS proposed definitions of ``behavioral health 
services,'' ``diversion control plan,'' ``emergency situation,'' 
``nationally recognized evidence-based guidelines,'' and ``practitioner 
incapacity'' in Sec.  8.2 to assist practitioners in understanding what 
is expected of them in making these attestations. These 
responsibilities would be aligned with the standards of ethical medical 
and business practice and are not expected to be burdensome to 
practitioners. Single State Authorities, State Opioid Treatment 
Authorities and other resources/entities exist to help in the 
development of patient placement in the event that transfer to other 
addiction treatment would be required, for example, if a practitioner 
chose to no longer practice at the higher patient limit. HHS proposed 
that practitioners approved at the higher limit would also be required 
to reaffirm their ongoing eligibility to fulfill these requirements 
every 3 years as described in Sec.  8.640.
    The comments and our responses are set forth below.
    Comment: HHS received a comment expressing the following concerns 
about the Request for Patient Limit Increase form: Question 7A9 assumes 
that physicians have an ``original'' 100 patients, and additional 
patients above the 100 patient level who would need to be transferred 
elsewhere in the event that a physician's renewal request for the 
higher patient limit is denied. However, the commenter noted that it is 
unrealistic to assume that a physician would be treating the exact same 
original 100 patients three years, or even one year, after being 
approved to treat more than 100 patients.
    Response: The patient level refers to those patients the 
practitioner is treating at the time the request is denied. It is the 
practitioner's responsibility to review his or her case load and 
identify which patients over the 100 patient limit he or she will 
notify.
    Comment: A commenter noted that Question 8 requires physicians to 
certify that they will only use Schedule III, IV, or V drugs or 
combinations of drugs that have been approved by the FDA for use in 
maintenance or detoxification treatment and that have not been the 
subject of an adverse determination. The commenter requests information 
about the purpose of this certification, as it appears to be a 
significant restriction on a physician's ability to practice medicine 
and prescribe other medications as needed.
    Response: The certification check box on the Request for Patient 
Limit Increase is to ensure that waivered practitioners certify that 
they are using only medications covered under 21 U.S.C. 823(g)(2)(C). 
Patients for whom a practitioner does not dispense or prescribe covered 
medications should not be counted against the patient limit. This does 
not mean that practitioners are prohibited from prescribing medications 
to treat conditions other than a substance use disorder among their 
office-based opioid treatment with buprenorphine patients.
    Comment: HHS received a comment recommending that it consider the 
impact of the 42 CFR part 2 substance use disorder treatment 
confidentiality provisions on patients who do not share their substance 
use records with their other providers.
    Response: The appropriate sharing of patient information is 
important. As such, HHS included an attestation that practitioners 
receiving a waiver to treat up to 275 patients provide appropriate 
releases of information, in accordance with Federal and State laws and 
regulations, including the Health Information Portability and 
Accountability Act and implementing regulations and 42 CFR part 2.

Summary of Regulatory Changes

    For the reasons set forth in the proposed rule, and considering the 
comments received, HHS is finalizing the provisions as proposed in 
Sec.  8.620 without modification.
Subpart F--How Will a Patient Request for a Higher Limit Be Processed 
(Sec.  8.625)
    HHS proposed Sec.  8.625 to describe how SAMHSA will process a 
Request for Patient Limit Increase. The process

[[Page 44723]]

for requesting a higher patient limit would be processed similarly to 
how the current 30 or 100 patient waiver is processed, with one 
difference. Whereas the lower patient limit waivers are not time 
limited, the waiver for the higher limit would have a term not to 
exceed 3 years with the option for renewal. Thus, a practitioner would 
be required to submit a new Request for Patient Limit Increase every 3 
years if he or she desired to continue treating up to the higher 
patient limit. In addition, we proposed, among other things, that if 
SAMHSA denied a practitioner's Request for Patient Limit Increase on 
the basis of deficiencies that could be resolved, SAMHSA would allow a 
designated time period for resolving such deficiencies. We also 
proposed that, if such deficiencies are not resolved during the 
designated time period, SAMHSA would deny the practitioner's Request 
for Patient Limit Increase. It should be noted that DEA has independent 
enforcement authority and this rule in no way affects that authority or 
changes the way in which DEA and SAMHSA interact with respect to 
waivers.
    After considering this process, the Department has made a minor 
modification to Sec.  8.625(c) by replacing the word ``will'' with the 
word ``may'' in the last sentence of this paragraph. This modification 
gives SAMHSA the flexibility to approve a practitioner's Request for 
Patient Limit Increase, if, for example, relevant deficiencies are 
resolved to the satisfaction of SAMHSA shortly after the expiration of 
the designated time period.
    The comments and HHS responses are set forth below.
    Comment: HHS received a comment recommending that the length of the 
term to prescribe buprenorphine should gradually increase to a term of 
3 years. The commenter stated that initially it should be a 1-year 
term, then a 2-year term, and then a 3-year term thereafter.
    Response: HHS has sought to strike the right balance between 
encouraging practitioners to apply for the higher patient limit and 
ensuring that they are providing high quality care. HHS believes that 
asking practitioners to submit a Request for Patient Limit Increase 
more frequently than every 3 years would create an unnecessary burden 
and act as a deterrent to requesting the higher limit.
    Comment: HHS received one comment suggesting that, rather than 
using a 3-year term, the highest patient limit should be based on a 
periodic review of the practice and its outcome statistics.
    Response: HHS does not have the administrative capacity to conduct 
a periodic review of all waivered practitioners' outcome statistics and 
other aspects of their practices beyond its anticipated oversight 
activities to ensure compliance with the rule.
    Comment: HHS received a comment suggesting that the turn-around 
time for approving waiver requests be shortened from 45 to 30 days.
    Response: HHS appreciates the commenters desire to shorten the time 
frame within which SAMHSA would process a Patient Request for a Higher 
Limit; however, due to staff and resource limitations, HHS believes the 
45 day time period is a balanced approach for ensuring requests are 
turned around in an appropriate time frame to meet both the 
practitioner and SAMHSA's needs. HHS notes that it views this timeframe 
as a maximum, not a minimum, and will endeavor to process these 
requests quickly.
Summary of Regulatory Changes
    For the reasons set forth in the proposed rule and considering the 
comment HHS received, HHS is finalizing the provisions as proposed in 
Sec.  8.625 with the exception of the word change noted in Sec.  
8.625(c).
Subpart F--What must practitioners do in order to maintain their 
approval to treat up to 275 patients under Sec.  8.625 (Sec.  8.630)
    HHS proposed Sec.  8.630 to describe the conditions for maintaining 
a waiver for each 3-year period for which waivers are valid, including 
maintenance of all eligibility requirements specified in Sec.  8.610, 
and all attestations made in accordance with Sec.  8.620(b). Compliance 
with the requirements specified in Sec.  8.620 would have to be 
continuous.
    HHS did not receive any comments specific to Sec.  8.630.

Summary of Regulatory Changes

    HHS did not receive any comments on this provision. Therefore, for 
the reasons set forth in the proposed rule, HHS is finalizing the 
provisions as proposed in Sec.  8.630 without modification.
Subpart F--RESERVED (Sec.  8.635)
    HHS proposed Sec.  8.635 to describe the reporting requirements for 
practitioners whose Request for Patient Limit Increase is approved 
under Sec.  8.625. HHS requested comments on whether the proposed 
reporting periods and deadline could be combined with other, existing 
reporting requirements in a way that would make reporting less 
burdensome for practitioners. HHS proposed the following reporting 
requirements:

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

    The comments and HHS responses are set forth below.
    HHS received a number of comments on these requirements. Many 
commenters expressed concern that the reporting requirements were 
burdensome and could decrease practitioners' interest in reaching the 
higher patient limit. Some commenters said that the reporting 
requirements would not ensure the appropriate level of behavioral 
health care. There were other concerns that the requirements were not 
consistent between practitioners who had waivers to treat up to 100 
patients and practitioners with the higher patient limit. In addition, 
there was confusion about the periodicity of the reporting 
requirements. Overall, many commenters requested clarity.
    HHS proposed to include reporting requirements as part of its 
approach to increasing access to MAT while ensuring that patients 
receive the full array of services that comprise evidence-based MAT and 
minimizing the risk that the medications provided for treatment are 
misused or diverted. HHS appreciates the comments received and, in 
light of them, has decided to delay finalizing this section of the 
proposed rule and to publish elsewhere in this issue of Federal 
Register a Supplemental Notice of Proposed Rulemaking on the reporting 
requirements proposed in Sec.  8.635 of the

[[Page 44724]]

NPRM. As explained in the Supplemental Notice of Proposed Rulemaking 
published elsewhere in this issue of the Federal Register, HHS will 
consider the public comments on this Supplemental Notice as well as 
comments already received on the March 30, 2016 NPRM in finalizing the 
reporting requirements. We expect to finalize the reporting 
requirements expeditiously following the receipt of additional public 
comment.

Summary of Regulatory Changes

    HHS is reserving Sec.  8.635
Subpart F--Process for Renewing Patient Limit Increase Approval (Sec.  
8.640)
    We proposed Sec.  8.640 to describe the process for a practitioner 
renewing his or her approval for the higher patient limit. In order for 
a practitioner to renew an approval, he or she would have to submit a 
renewal Request for Patient Limit Increase in accordance with the 
procedures outlined under Sec.  8.620 at least 90 days before the 
expiration of the approval term.
    The comments and HHS responses are set forth below.
    Comment: HHS received several comments recommending that the 
renewal request be synchronized with the renewal of the DEA 
registration in an effort to reduce administrative burdens.
    Response: HHS agrees that coordination among Federal agencies is 
beneficial and will work with DEA to synchronize these forms to the 
extent possible.
    Comment: HHS received a comment stating that the current 
certification and recertification process should be retained and that 
additional recertification requirements are unnecessary. The commenter 
also stated that the DEA registration renewal process, as well as the 
regular oversight of waivered physicians conducted by SAMHSA, is 
sufficient to ensure safety and proper prescribing practices and that a 
duplicative recertification process will only discourage participation 
by providers.
    Response: HHS believes that due to the fact that practitioners with 
the higher patient limit will now be able to treat up to almost 3 times 
as many patients as prior to the rule, additional requirements related 
to renewing the practitioner's Request for Patient Limit Increase is 
prudent to ensure high quality care and minimize diversion.
    Comment: HHS received a comment stating that the 90 day timeline 
for receiving approval is too long. The commenter also stated that 
language should be added regarding when a response to a request should 
be provided and what one does when the response does not come by the 
stated time.
    Response: HHS believes the commenter was confused with respect to 
the 90 day time period. The NPRM indicated that ``Practitioners who 
intend to continue to treat up to 200 patients beyond their current 3 
year approval term must submit a renewal Request for Patient Limit 
Increase in accordance with the procedures outlined under Sec.  8.620 
at least 90 days before the expiration of their approval term.'' It 
does not state that SAMHSA has 90 days to process the renewal request. 
In addition, the proposed rule states that ``If SAMHSA does not reach a 
final decision on a renewal Request for Patient Limit Increase before 
the expiration of a practitioner's approval term, the practitioner's 
existing approval term will be deemed extended until SAMHSA reaches a 
final decision.'' Thus, the preamble of the proposed rule discusses 
what happens if the response from SAMHSA is not obtained by a certain 
date.

Summary of Regulatory Changes

    For the reasons set forth in the proposed rule, and considering the 
comments received, HHS is finalizing the provisions as proposed in 
Sec.  8.640 without modification.
Subpart F--Responsibilities of Practitioners Who Do Not Submit a 
Renewal Request for Patient Limit Increase or Whose Renewal Request Is 
Denied (Sec.  8.645)
    HHS proposed Sec.  8.645 to describe the responsibilities of 
practitioners who do not submit a renewal Request for Patient Limit 
Increase or whose renewal request is denied. Under Sec.  8.620(b)(7), 
practitioners would notify all patients affected above the 100 patient 
limit that the practitioner would no longer be able to provide MAT 
services using covered medications and would make every effort to 
transfer patients to other addiction treatment.

Summary of Regulatory Changes

    HHS did not receive any comments on this provision. Therefore, for 
the reasons set forth in the proposed rule, HHS is finalizing the 
provisions as proposed in Sec.  8.645 without modification.
Subpart F--Suspension or Revocation of a Practitioner's Patient Limit 
Increase Approval (Sec.  8.650)
    HHS proposed Sec.  8.650 to describe under what circumstances 
SAMHSA would suspend or revoke a practitioner's patient limit increase 
of 200. If SAMHSA had reason to believe that immediate action would be 
necessary to protect public health or safety, SAMHSA would suspend the 
practitioner's patient limit increase of 200. If SAMHSA determined that 
the practitioner had made misrepresentations in his or her Request for 
Patient Limit Increase, or if the practitioner no longer satisfied the 
requirements of this subpart, or he or she had been found to have 
violated the CSA pursuant to 21 U.S.C. 824(a), SAMHSA would revoke the 
practitioner's patient limit increase of 200. It should be noted that 
DEA has independent enforcement authority and this rule in no way 
affects that authority or changes the way in which DEA and SAMHSA 
interact with respect to waivers.
    The comments and HHS responses are set forth below.
    Comment: HHS received a comment that practitioners who perform 
poorly on outcome and quality measures should be limited to 100 
patients or less, or even have their waiver revoked if outcomes and 
quality are extremely poor.
    Response: HHS believes allowing for suspension or revocation when 
SAMHSA determines that a practitioner no longer satisfies the 
requirements of the rule is appropriate and commensurate with ensuring 
that patients receive quality care. Additionally, such requirements 
relating to practitioners who have waivers to treat up to 30 and 100 
patients are beyond the scope of this rule.
    Comment: HHS received a comment requesting that we add an appeals 
mechanism for physicians to dispute erroneous determinations of not 
being in compliance with requirements for the patient limit increase.
    Response: HHS declines to set forth a specific appeal mechanism in 
the rule, but notes that practitioners are able to re-apply if their 
Request for Patient Limit Increase is denied.

Summary of Regulatory Changes

    The proposed language under Sec.  8.650 provided only one 
circumstance under which SAMHSA could suspend a practitioner's Patient 
Limit Increase approval, and three instances under which SAMHSA could 
revoke this approval. After further consideration, HHS has modified the 
language in Sec.  8.650 in an effort to allow the Secretary to suspend 
or revoke a practitioner's Request for Patient Limit Increase approval 
on the basis of any of

[[Page 44725]]

the criteria identified in this section to provide additional 
flexibility. For the reasons set forth in the proposed rule and 
considering the comments received, HHS is finalizing the remaining 
provisions of this section as proposed in the NPRM.
Subpart F--Practitioner Patient Limit Increase During Emergency 
Situations (Sec.  8.655)
    HHS proposed Sec.  8.655 to describe the process, including the 
information and documentation necessary, for a practitioner with an 
approved 100 patient limit to request approval to temporarily treat up 
to 200 patients in an emergency situation. The intention of this 
provision is to help assure continuity of care for patients whose care 
might otherwise be abruptly terminated due to the death or disability 
of their practitioner. This provision would also help communities 
respond rapidly to a sudden increase in demand for medication-assisted 
treatment. Sudden increases in demand for treatment may be experienced 
when there is a local disease outbreak associated with drug use, or 
when a natural or human-caused disaster either displaces persons in 
treatment from their practitioner or program or destroys program 
infrastructure. The emergency provision generally would not be intended 
to correct poor resource deployment due to lack of planning. The 
emergency provision of the proposed rule would only be considered if 
other options for addressing the increased demand for medication-
assisted treatment could not address the situation.
    HHS proposed that the practitioner must provide information and 
documentation that: (1) Describes the emergency situation in sufficient 
detail so as to allow a determination to be made regarding whether the 
emergency qualifies as an emergency situation as defined in Sec.  8.2, 
and that provides a justification for an immediate increase in that 
practitioner's patient limit; (2) identifies a period of time in which 
the higher patient limit should apply, and provides a rationale for the 
period of time requested; and (3) describes an explicit and feasible 
plan to meet the public and individual health needs of the impacted 
persons once the practitioner's approval to treat up to the higher 
patient limit expires. Prior to taking action on a practitioner's 
request under this section, SAMHSA shall consult, to the extent 
practicable, with the appropriate governmental authorities in order to 
determine whether the emergency situation that a practitioner describes 
justifies an immediate increase in the higher patient limit. If, after 
consultation with the governmental authorities, SAMHSA determines that 
a practitioner's request under this section should be granted, SAMHSA 
will notify the practitioner that his or her request has been approved. 
The period of such approval shall not exceed six months. A practitioner 
wishing to receive an extension of the approval period granted must 
submit a request to SAMHSA at least 30 days before the expiration of 
the six month period and certify that the emergency situation 
continues. Except as provided in this section and Sec.  8.650, 
requirements in other sections under subpart F do not apply to 
practitioners receiving waivers in this section.
    The comments and HHS responses are set forth below.
    Comment: HHS received a comment that the governmental authority, 
not the physician, should make a request to temporarily treat the 
higher patient limit in emergency situations.
    Response: The waiver authorized under 21 U.S.C. 823(g)(2) may be 
granted to practitioners who dispense or prescribe covered medications 
to patients. Therefore, only practitioners may request a temporary 
patient limit increase under emergency situations. However, along with 
working with practitioners, SAMHSA will consult, to the extent 
possible, with governmental authorities to address emergency 
situations.
    Comment: HHS received a comment recommending that it focus 
resources on creating sustainable, expanded treatment capacity to 
relieve those physicians impacted by the emergency request who may not 
be qualified or have the infrastructure to treat over 100 patients per 
the proposed rule.
    Response: HHS agrees with the commenter that sustainable, expanded 
treatment capacity is the goal for all practitioners who experience 
emergency situations. By granting an extension of the six-month 
emergency provision, this will allow practitioners with a waiver to 
treat up to 100 patients, with up to a year of experience with 
prescribing covered medications, and will better position them to apply 
for a Request for Patient Limit Increase.
    Comment: HHS received a small number of comments asking how quickly 
providers will be notified about whether they are approved to increase 
their patient limit during an emergency, with one commenter requesting 
that this information be included in the final rule. Another commenter 
recommended that providers receive a response within 48 to 72 hours.
    Response: Every effort will be made to assure prompt decision-
making and communication regarding requests to increase a 
practitioner's patient limit in response to an emergency. Given the 
wide variety of situations, number of stakeholders and decision-makers 
involved, and range of acuity of possible emergency situations, a 
specific deadline will not be established in the final rule.
    Comment: HHS received a comment that the application process for an 
emergency should be simplified.
    Response: HHS believes the application process outlined in the rule 
is necessary to ensure public safety and welfare. Furthermore, HHS 
believes that there is a compelling reason to require an application 
process given that the practitioner could be taking on almost 3 times 
as many patients without the necessary training or qualified practice 
setting supports.
    Comment: HHS received a comment recommending that the State Opioid 
Treatment Authority or Single State Agency determine whether physicians 
can assure continuous access to care in the event of practitioner 
incapacity or emergency and whether physicians will be able to notify 
all patients that they are no longer able to provide buprenorphine, in 
the event that the request for the higher patient limit is not renewed 
or the renewal request is denied.
    Response: HHS cannot address this issue within the scope of this 
rule.
    Comment: HHS received a comment stating that emergency provisions 
should be explicitly expanded to include exemption from the patient 
limit for categories of patients in immediate need of treatment where 
no other practitioner is available. The comment specifically mentioned 
pregnant women with an opioid use disorder, and persons with a recent 
non-fatal opioid overdose.
    Response: The patient limit applies to practitioners and not 
patients; therefore, the circumstances related to the availability of 
practitioners with waivers must dictate the emergency, not the 
circumstances of individual patients.
    Comment: HHS received a comment recommending that practitioners be 
able to treat an unlimited number of patients during an emergency.
    Response: HHS does not believe that this approach is warranted at 
this time.
    Comment: HHS received several comments describing a need for a 
clearer definition of emergency situations.
    Response: HHS' intent is to reserve this option for true emergency 
situations. Recognizing that no two

[[Page 44726]]

emergencies look the same, HHS envisions that this option for a 
temporary higher patient limit could be triggered when a waivered 
practitioner dies or becomes physically or mentally incapacitated or 
whose waiver is suspended or revoked. Other possible scenarios include: 
Unforeseen displacement of a large population of individuals in need of 
medication-assisted treatment due to disaster; outbreak of acute 
infections that are blood borne or otherwise associated with injection 
drug use such as HIV. In all cases the emergency increase of a 
practitioner's patient limit is meant to be temporary. The affected 
community and practitioner(s) should plan to definitively meet the need 
for treatment and resolve the emergency by expanding all forms of MAT 
and meeting criteria for the higher patient limit via non-emergency 
criteria at the earliest possible date.

Summary of Regulatory Changes

    For the reasons set forth in the proposed rule, and considering the 
comments received, HHS is finalizing the provisions as proposed in 
Sec.  8.655 without modification.

III. Information Collection Requirements

    The NPRM called for new collections of information under the 
Paperwork Reduction Act of 1995. The final rule calls for the most of 
the same collections of information as the NPRM. As defined in 
implementing regulations, ``collection of information'' comprises 
reporting, recordkeeping, monitoring, posting, labeling, and other 
similar actions. In this section, we first identify and describe the 
types of information applicants and waivered practitioners must collect 
and report, and then we provide 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.
    OMB Control Number: 0930-03XX.
    Summary of the Collection of Information: The final rule estimates 
up to six categories of information collection, each of which is 
described in the following analysis:
    A. Approval, 42 CFR 8.620(a) through (c): In order for a 
practitioner to receive approval for a patient limit of 275, a 
practitioner must meet all of the requirements specified in Sec.  8.610 
and submit a Request for Patient Limit Increase to SAMHSA that includes 
all of the following:
     Completed 3-page Request for Patient Limit Increase Form, 
a draft of which was posted in the public docket along with the NPRM;
     Statement certifying that the practitioner:
    [cir] Will adhere to nationally recognized evidence-based 
guidelines for the treatment of patients with opioid use disorders;
    [cir] Will provide patients with necessary behavioral health 
services as defined in Sec.  8.2 or will provide such services through 
an established formal agreement with another entity to provide 
behavioral health services;
    [cir] Will provide appropriate releases of information, in 
accordance with Federal and State laws and regulations, including the 
Health Information Portability and Accountability Act Privacy Rule and 
part 2, if applicable, to permit the coordination of care with 
behavioral health, medical, and other service practitioners;
    [cir] Will use patient data to inform the improvement of outcomes;
    [cir] Will adhere to a diversion control plan to manage the covered 
medications and reduce the possibility of diversion of covered 
medications from legitimate treatment use;
    [cir] Has considered how to assure continuous access to care in the 
event of practitioner incapacity or an emergency situation that would 
impact a patient's access to care as defined in Sec.  8.2; and
    [cir] Will notify all patients above the 100 patient level, in the 
event that the request for the higher patient limit is not renewed or 
the renewal request is denied, that the practitioner will no longer be 
able to provide MAT services using buprenorphine to them and make every 
effort to transfer patients to other addiction treatment.
    B. Diversion Control Plan, 42 CFR 8.12(c)(2): Creating and 
maintaining a diversion control plan is one of the requirements that 
practitioners must attest to before they are approved to treat at the 
higher limit. This plan is not required to be submitted to SAMHSA.
    C. Renewal, 42 CFR 8.640: Describes the process for a practitioner 
renewing his or her approval for the higher patient limit. In order for 
a practitioner to renew an approval, he or she must submit a renewal 
Request for Patient Limit Increase in accordance with the procedures 
outlined under Sec.  8.620 at least 90 days before the expiration of 
the approval term.
    D. Patient Notice, 42 CFR 8.645: Describes the responsibilities of 
practitioners who do not submit a renewal Request for Patient Limit 
Increase or whose renewal request is denied. Practitioners who do not 
renew their Request for Patient Limit Increase or whose renewal request 
is denied must notify all patients above the 100 patient limit that the 
practitioner will no longer be able to provide MAT services using 
covered medications and make every effort to transfer patients to other 
addiction treatment. The Patient Notice is a model notice to guide 
practitioners in this situation when they notify their patients.
    E. Emergency Provisions, 42 CFR 8.655: Describes the process for 
practitioners with a current waiver to prescribe up to 100 patients, 
and who are not otherwise eligible to treat up to 275 patients, to 
request a temporary increase to treat up to 275 patients in order to 
address emergency situations as defined in Sec.  8.2. To initiate this 
process, the practitioner shall provide information and documentation 
that: (1) Describes the emergency situation in sufficient detail so as 
to allow a determination to be made regarding whether the situation 
qualifies as an emergency situation as defined in Sec.  8.2, and that 
provides a justification for an immediate increase in that 
practitioner's patient limit; (2) Identifies a period of time, not 
longer than 6 months, in which the higher patient limit should apply, 
and provides a rationale for the period of time requested; and (3) 
Describes an explicit and feasible plan to meet the public and 
individual health needs of the impacted persons once the practitioner's 
approval to treat up to 275 patients expires. If a practitioner wishes 
to receive an extension of the approval period granted under this 
section, he or she must submit a request to SAMHSA at least 30 days 
before the expiration of the 6-month period, and certify that the 
emergency situation as defined in Sec.  8.2 necessitating an increased 
patient limit continues.
    Annual burden estimates for these requirements are summarized in 
the following table:

[[Page 44727]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Burden/
             42 CFR citation                 Purpose of submission      Number of    Responses/     response    Total burden   Hourly wage   Total wage
                                                                       respondents   respondent       (hr.)        (hrs.)       cost ($)      cost ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.620(a) through (c)....................  Request for Patient Limit            517             1            .5           259         93.74        24,232
                                           Increase.
8.12(c)(2)..............................  Diversion Control Plan....           517             1            .5           259         93.74        24,232
8.640...................................  Renewal Request for a                  0             1            .5             0         93.74             0
                                           Patient Limit Increase.
8.645...................................  Patient Notice............             0             1             3             0         93.74             0
8.655(d)................................  Request for a Temporary               10             1             3            30         64.47         1,934
                                           Patient Increase for an
                                           Emergency.
                                                                     -----------------------------------------------------------------------------------
    Total...............................  ..........................         2,394  ............  ............         4,598  ............        50,398
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Note that these estimates differ from those found in the RIA 
because the estimates here are wage cost estimates while the estimates 
in the RIA are resource cost estimates which incorporate costs 
associated with overhead and benefits.
    HHS received several comments regarding the Collection of 
Information.
    One commenter wanted to include in the Request for Patient Limit 
Increase information that required the implementation of random tablet/
film counts and urine screens. Another commenter wanted mandatory 
Point-of-Care Urine Drug Screens on each visit to document the presence 
of buprenorphine/naloxone and the absence of other opioids. HHS also 
received a comment recommending that drug testing be included as part 
of treatment with buprenorphine and thus noted in the information that 
would be collected in the Request for Patient Limit Increase.
    HHS believes that drug screens are likely part of a practitioner's 
diversion control plan and part of the data that will inform the 
practitioner's ability to help the patient achieve better outcomes. 
Thus, HHS is not revising the information to be collected as part of 
the Request for Patient Limit Increase.
    HHS received a comment recommending that pharmacists be included in 
the pool of practitioners to which a release of information should be 
considered.
    HHS believes it may be appropriate to release certain information 
to pharmacists if the patient provides consent. HHS declines to require 
that pharmacists be included in the pool of practitioners to which 
information may be released.

 IV. Regulatory Impact Analysis

A. Introduction

    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).
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health, and safety 
effects; distributive impacts; and equity). Executive Order 13563 is 
supplemental to and reaffirms the principles, structures, and 
definitions governing regulatory review as established in Executive 
Order 12866. HHS expects that this final rule will have an annual 
effect on the economy of $100 million or more in at least 1 year and 
therefore is a significant regulatory action as defined by Executive 
Order 12866.
    The Regulatory Flexibility Act (RFA) requires agencies that issue a 
regulation to analyze options for regulatory relief of small businesses 
if a rule has a significant impact on a substantial number of small 
entities. The RFA generally defines a ``small entity'' as: (1) A 
proprietary firm meeting the size standards of the Small Business 
Administration; (2) a nonprofit organization that is not dominant in 
its field; or (3) a small government jurisdiction with a population of 
less than 50,000 (States and individuals are not included in the 
definition of ``small entity''). HHS considers a rule to have a 
significant economic impact on a substantial number of small entities 
if at least 5 percent of small entities experience an impact of more 
than 3 percent of revenue. HHS anticipates that the final rule will not 
have a significant economic impact on a substantial number of small 
entities. We provide supporting analysis in section F.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $146 million, using the most current (2015) implicit 
price deflator for the gross domestic product. HHS expects this final 
rule to result in expenditures that would exceed this amount.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct requirement costs on State and local governments or has 
federalism implications. HHS has determined that the final rule does 
not contain policies that would have substantial direct effects on the 
States, on the relationship between the Federal Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. The changes in the rule represent the 
Federal Government regulating its own program. Accordingly, HHS 
concludes that the final rule does not contain policies that have 
federalism implications as defined in Executive Order 13132 and, 
consequently, a federalism summary impact statement is not required.

B. Summary of the Final Rule

    Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows 
individual practitioners to dispense and prescribe Schedule III, IV, or 
V controlled substances that have been approved by the FDA specifically 
for use in

[[Page 44728]]

maintenance and detoxification treatment without obtaining the separate 
registration required by 21 CFR 1301.13(e) and imposes a limit on the 
number of patients a practitioner may treat at any one time.
    Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners 
who file an initial NOI to treat a maximum of 30 patients at a time. 
After one year, the practitioner may file a second NOI indicating his/
her intent to treat up to 100 patients at a time. To qualify, the 
practitioner must be a physician, possess a valid license to practice 
medicine, be a registrant of the DEA, have the capacity to refer 
patients for appropriate counseling and other appropriate ancillary 
services, and have completed required training. The training 
requirement may be satisfied in several ways: one may hold board 
certification in addiction psychiatry from the American Board of 
Medical Specialties or addiction medicine from the American Osteopathic 
Association; hold an addiction certification from the American Society 
of Addiction Medicine (ASAM); complete an 8-hour training provided by 
an approved organization; have participated as an investigator in one 
or more clinical trials leading to the approval of a medication that 
qualifies to be prescribed under 21 U.S.C. 823(g)(2); or complete other 
training or have such other experience as the State medical licensing 
board or Secretary of HHS considers to demonstrate the ability of the 
practitioner to treat and manage persons with opioid use disorder.
    Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is 
authorized to promulgate regulations that change the total number of 
patients that a practitioner may treat at any one time.
    The laws pertaining to the utilization of buprenorphine were last 
revised approximately ten years ago at a time when the extent of the 
opioid public health crisis was less well-documented. The purpose of 
the final rule is to expand access to MAT with buprenorphine while 
encouraging practitioners administering buprenorphine to ensure their 
patients can receive the full array of services that comprise evidence-
based MAT and to minimize the risk of drug diversion. The final rule 
revises the highest patient limit from 100 patients per practitioner 
with an existing waiver (waivered practitioner) to 275 patients for 
practitioners who meet certain criteria in addition to those 
established in statute. Practitioners who have had a waiver to treat 
100 patients for at least one year could obtain approval to treat up to 
275 patients if they meet the requirements defined in this final rule 
and after submitting a Request for Patient Limit Increase to SAMHSA. 
Practitioners approved to treat up to 275 patients will also be 
required to accept greater responsibility for providing behavioral 
health services and care coordination, and ensuring quality assurance 
and improvement practices, diversion control, and continuity of care in 
emergencies. The higher limit also requires regularly reaffirming the 
practitioner's ongoing eligibility and participating in data reporting 
and monitoring as required by SAMHSA. In addition, practitioners in 
good standing with a current waiver to treat up to 100 patients (i.e., 
the practitioner has filed a NOI and satisfied all required criteria) 
may request approval to treat up to 275 patients in specific emergency 
situations for a limited time period specified in the rule. We 
anticipate that qualifying emergency situations will occur very 
infrequently. As a result, we do not anticipate that this provision 
will contribute significantly to the impact of this final rule. SAMHSA 
will review all emergency situation requests, to the extent 
practicable, in consultation with appropriate governmental authorities 
before such requests are granted. Finally, the final rule defines 
patient limit in such a way that firmly ties the individual patient to 
the prescribing practitioner of record rather than to the covering 
practitioner at a given moment. This will enable waivered practitioners 
to provide reciprocal cross-coverage of patients for brief periods, 
such as weekends or vacations, without being considered to be in excess 
of their respective individual limits. This will help to ensure 
continuity of care in select situations, and we expect that this will 
primarily affect the timing of treatment rather than the quantity of 
treatment. As a result, we do not anticipate that the changes related 
to cross-coverage will contribute significantly to the impact of this 
final rule, and we do not estimate associated costs and benefits.

C. Need for the Rule

    The United States is facing an unprecedented increase in 
prescription opioid misuse, heroin use, and opioid-related overdose 
deaths. In 2014, 18,893 overdose deaths involved prescription opioids 
and 10,574 involved heroin.\3\ Underlying many of these deaths is an 
untreated opioid use disorder.4 5 6 In 2014, more than 2.2 
million people met diagnostic criteria for an opioid use disorder.\7\
---------------------------------------------------------------------------

    \3\ Center for Disease Control and Prevention, National Center 
for Health Statistics, National Vital Statistics System, Mortality 
File. (2015). Number and Age-Adjusted Rates of Drug-poisoning Deaths 
Involving Opioid Analgesics and Heroin: United States, 2000-2014. 
Atlanta, GA: Center for Disease Control and Prevention. Available at 
https://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf.
    \4\ Johnson EM, Lanier WA, Merrill RM, et al. Unintentional 
Prescription opioid-related overdose deaths: description of 
decedents by next of kin or best contact, Utah, 2008-2009. J Gen 
Intern Med. 2013;28(4):522-529.
    \5\ Hall AJ, Logan JE, Toblin RL, et al. Patterns of abuse among 
unintentional pharmaceutical overdose fatalities. JAMA. 
2008;300(22):2613-2620.
    \6\ Bohnert AS, Valenstein M, Bair MJ, et al. Association 
between opioid prescribing patterns and opioid overdose-related 
deaths. JAMA. 2011;305(13):1315-1321.
    \7\ Jones CM. Unpublished analysis of the 2014 National Survey 
on Drug Use and Health Public Use File. 2015.
---------------------------------------------------------------------------

    Beyond the increase in overdose deaths, the health and economic 
consequences of opioid use disorders are substantial. In 2011, the most 
recent year data are available, an estimated 660,000 emergency 
department visits were due to the misuse or abuse of prescription 
opioids, heroin, or both.\8\ A recent analysis estimated the costs 
associated with emergency department and hospital inpatient care for 
opioid abuse-related events in the United States was more than $9 
billion per year.\9\ The societal costs of prescription opioid abuse, 
dependence, and misuse in the United States in 2011 were estimated at 
$55.7 billion annually, not including societal costs related to heroin 
use.\10\
---------------------------------------------------------------------------

    \8\ Id.
    \9\ Chandwani HS, Strassels SA, Rascati KL, Lawson KA, Wilson 
JP. Estimates of charges associated with emergency department and 
hospital inpatient care for opioid abuse-related events. J Pain 
Palliat Care Pharmacother. 2013;27(3):206-13.
    \10\ Birnhaum HG, White AG, Schiller M, Waldman T, et al. 
Societal costs of prescription opioid abuse, dependence, and misuse 
in the United States. Pain Med. 2011;12(4):657-67.
---------------------------------------------------------------------------

    Beginning around 2006, the United States started to experience a 
significant increase in the rate of hepatitis C virus infections. The 
available epidemiology indicates this increase is largely due to the 
increased injection of prescription opioids and heroin.11 12 
In addition, in 2015, a large outbreak of HIV in a small rural 
community in Indiana was linked to injection of prescription opioids, 
primarily injection of the prescription opioid oxymorphone. Over 80 
percent

[[Page 44729]]

of the 135 cases, as of April 2015, identified in the outbreak were co-
infected with hepatitis C virus.\13\ The infectious disease 
consequences associated with opioid injection have been found to 
account for a significant proportion of the economic burden and 
disability associated with opioid use disorders.\14\
---------------------------------------------------------------------------

    \11\ Suryaprasad AG, White JZ, Xu F, et al. Emerging epidemic of 
hepatitis C virus infections among young nonurban persons who inject 
drugs in the United States, 2006-2012. Clin Infect Dis 2014;59:1411-
9.
    \12\ Zibbell JE, Iqbal K, Patel RC, Suryaprasad A, et al. 
Increases in hepatitis C virus infection related to injection drug 
use related to injection drug use among persons aged <=30 years--
Kentucky, Tennessee, Virginia, and West Virginia, 2006-2012. MMWR 
Morb Mortal Wkly Rep. 2015;64(17):453-8.
    \13\ Conrad C, Bradley HM, Broz D, et al. Community outbreak of 
HIV infection linked to injection drug use of oxymorphone--Indiana, 
2015. MMWR Morb Mortal Wkly Rep. 2015;64(16): 443-4.
    \14\ Degenhardt L, Whiteford HA, Ferrari AJ, Charlson FJ, et al. 
Global burden of disease attributable to illicit drug use and 
dependence: findings from the Global Burden of Disease Study 2010. 
Lancet 2013;382(9904):1564-74.
---------------------------------------------------------------------------

    There is robust literature documenting the effectiveness and cost-
effectiveness of the use of buprenorphine in the treatment of opioid 
use disorder. Buprenorphine has been shown to increase treatment 
retention and to reduce opioid use, relapse risk, and risk behaviors 
that transmit HIV and hepatitis.15 16 17 18 19 20 Reductions 
in opioid-related mortality have been shown for 
buprenorphine.21 22 23
---------------------------------------------------------------------------

    \15\ Clark RE, Baxter JD, Aweh G, O'Connell E, et al. Risk 
factors for relapse and higher costs among Medicaid members with 
opioid dependence or abuse: opioid agonists, comorbidities, and 
treatment history. J Subst Abuse Treat. 2015;57:75-80.
    \16\ Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine 
maintenance versus placebo or methadone maintenance for opioid 
dependence. Cochrane Database Syst Rev. 2014 Feb 6;2:CD002207. doi: 
10.1002/14651858.CD002207.pub4.
    \17\ Kraus ML, Alford DP, Kotz MM, et al. Statement of the 
American Society of Addiction Medicine consensus panel on the use of 
buprenorphine in office-based treatment of opioid addiction. J 
Addict Med. 2011;5(4):254-263.
    \18\ Bonhomme J, Shim RS, Gooden R, Tyus D, Rust G. Opioid 
addiction and abuse in primary care practice: a comparison of 
methadone and buprenorphine as treatment options. J Natl Med Assoc. 
2012;104(7-8):342-350.
    \19\ Tsui JI, Evans JL, Lum PJ, Hahn JA, Page K. Association of 
opioid agonist therapy with lower incidence of hepatitis C virus 
infection in young adult injection drug users. JAMA Intern Med. 
2014;174(12):1974-1981.
    \20\ Woody GE, Bruce D, Korthuis PT, Chhatre S, et al. HIV risk 
reduction with buprenorphine-naloxone or methadone: findings from a 
randomized trial. J Acuir Immune Defic Syndr. 2015;68(5):554-61.
    \21\ Center for Substance Abuse Treatment. Clinical Guidelines 
for the Use of Buprenorphine in the Treatment of Opioid Addiction. 
Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. 
(SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Health 
Services Administration, 2004.
    \22\ Schwartz RP, Gryczynski J, O'Grady KE, et al. Opioid 
agonist treatments and heroin overdose deaths in Baltimore, 
Maryland, 1995-2009. Am J Public Health. 2013;103(5):917-922.
    \23\ Carrieri MP, Amass L, Lucas GM, Vlahov D, Wodak A, Woody 
GE. Buprenorphine use: the international experience. Clin Infect 
Dis. 2006;43(suppl 4):S197-S215.
---------------------------------------------------------------------------

    Despite these well-documented benefits, buprenorphine treatment for 
opioid use disorder is significantly underutilized and often does not 
incorporate the full scope of recommended clinical practices that make 
up evidence-based MAT. Generally, there is significant unmet need for 
MAT treatment among individuals with opioid use disorders.\24\ There is 
also substantial geographic variation in the capacity to prescribe 
buprenorphine. Research suggests that 10 percent of the population live 
in areas where there is a limited number of practitioners eligible to 
prescribe buprenorphine or in counties that have no practitioners with 
a waiver to prescribe buprenorphine.\25\ These are primarily rural 
counties and areas located in the middle of the country.\26\ Only about 
5 percent of practitioners currently authorized to treat up to the 100 
patient limit are located in rural counties.\27\
---------------------------------------------------------------------------

    \24\ Jones CM, Campopiano M, Baldwin G, McCance-Katz E. National 
and state treatment need and capacity for opioid agonist medication-
assisted treatment. Am J Public Health 2015;105(8):e55-63.
    \25\ Rosenblatt RA, Andrilla CH, Catlin M, Larson EH. Geographic 
and specialty distribution of US physicians trained to treat opioid 
use disorder. Ann Fam Med. 2015 Jan-Feb;13(1):23-6. doi: 10.1370/
afm.1735.
    \26\ Dick AW, Pacula RL, Gordon AJ, Sorbero M, et al. Growth in 
buprenorphine waivers for physicians increased potential access to 
opioid agonist treatment, 2002-11. Health Affairs 2015;34(6):1028-
1034.
    \27\ Stein BD, Pacula RL, Gordon AJ, Burns RM, et al. Where is 
buprenorphine dispensed to treat opioid use disorders? The role of 
private offices, opioid treatment programs, and substance abuse 
treatment facilities in urban and rural counties. Milbank Quarterly 
2015;93(3):56561-583.
---------------------------------------------------------------------------

    Evidence suggests that utilization of buprenorphine is limited 
directly by the existence of treatment limits. Practitioners currently 
providing MAT with buprenorphine under 21 U.S.C. 823(g)(2) report that 
being limited to treating not more than 100 patients at a time is a 
barrier to expanding treatment.28 29 30 A recent survey by 
ASAM found that among the 1,309 respondents (approximately 35 percent 
of ASAM's membership), comprising a range of addiction stakeholders, 
including those working in OTPs and outpatient or office-based practice 
settings, 544, or 41.6 percent, were currently treating more than 80 
patients, and 796, or 60.8 percent, reported there was demand for 
treatment in excess of the current 100 patient limit under the Drug 
Addiction Treatment Act of 2000 (Pub. L. 106-310).\31\ Increasing the 
number of patients that a single practitioner can treat with 
buprenorphine, then, could have a direct impact on buprenorphine 
capacity and utilization.
---------------------------------------------------------------------------

    \28\ Molfenter T, Sherbeck C, Zehner M, Starr S. Buprenorphine 
Prescribing Availability in a Sample of Ohio Specialty Treatment 
Organizations. J Addict Behav Ther Rehabil. 2015;4(2). pii: 1000140.
    \29\ Molfenter T, Sherbeck C, Zehner M, Quanbeck A, et al. 
Implementing buprenorphine in addiction treatment: payer and 
provider perspectives in Ohio. Subst Abuse Treat Prev Policy. 
2015;10:13. doi: 10.1186/s13011-015-0009-2.
    \30\ Substance Abuse and Mental Health Services Administration. 
(2006). The SAMHSA Evaluation of the Impact of the DATA Waiver 
Program. Retrieved from https://www.buprenorphine.samhsa.gov/FOR_FINAL_summaryreport_colorized.pdf.
    \31\ American Society of Addiction Medicine. 2015. Available at: 
https://www.asam.org/magazine/read/article/2015/12/08/addiction-specialists-weigh-in-on-the-data-2000-patient-limits.
---------------------------------------------------------------------------

    In addition to direct barriers to treating additional patients 
imposed by the patient limit, there are indirect barriers to expanding 
treatment capacity. In particular, increases in a practitioner's 
ability to expand his or her patient base will allow the practitioner 
to take advantage of economies of scale to increase the practice's 
efficiency. For example, a practitioner with a larger practice is more 
likely to be able to afford to hire specialized support staff, which 
allows the practitioner to reduce time spent on tasks best suited for 
another individual. This may help to enable the provision of the full 
complement of ancillary services that make up evidence-based MAT. 
Increasing a practitioner's maximum capacity for treatment has the 
potential to make treating patients with buprenorphine more 
economically feasible, with the likelihood of increasing capacity to 
prescribe buprenorphine.
    The statutory change implemented in 2007 that increased the limit 
on the number of buprenorphine patients a practitioner could treat from 
30 to 100, after having a 30 patient limit for 1 year, was associated 
with a significant increase in the use of buprenorphine.\32\ In 2007, 
when practitioners were first able to treat up to 100 patients, nearly 
25 percent of eligible practitioners submitted a NOI to treat 100 
patients (1,937 practitioners out of 7,887 practitioners).\33\ The 
findings from the ASAM survey discussed above and additional 
information indicate there is sufficient demand from both providers and 
patients to raise the patient limit. In addition, based on the 
experience in 2007, it is expected that some proportion of eligible 
practitioners will respond to the final rule by submitting a Request 
for Patient Limit Increase to treat up to 275 patients.
---------------------------------------------------------------------------

    \32\ Stein supra note 27.
    \33\ Jones, supra note 24.

---------------------------------------------------------------------------

[[Page 44730]]

D. Analysis of Benefits and Costs

a. Increased Ability for Waivered Practitioners To Treat Patients With 
Buprenorphine-Based MAT
    This final rule directly expands opportunities for physicians who 
currently treat or who may treat patients with buprenorphine, as they 
will now have the potential to treat up to 275 patients with 
buprenorphine. We believe that this may translate to a financial 
opportunity for these physicians, depending on the costs associated 
with treating these additional patients.
    Relatedly, this final rule may increase the value of the waiver to 
treat opioid use disorder under 21 U.S.C. 823(g)(2). The final rule 
requires practitioners to have a waiver to treat 100 patients for 1 
year and to have additional credentialing as defined in Sec.  8.2 or to 
practice in a qualified practice setting as defined in the rule in 
order to request approval to treat up to 275 patients. If getting to 
the 275-patient limit provides sufficient benefits to practitioners, 
this final rule may also increase incentives for other practitioners to 
apply for the lower patient limit waivers, insofar as they are 
milestones towards the 275-patient limit. In addition, this rule may 
also make it more valuable for practitioners to have additional 
credentialing as defined in Sec.  8.2, or to practice in a qualified 
practice setting. The final rule, then, may increase the number of 
practitioners in these categories and thus the number of practitioners 
eligible for the 275-patient limit in the future.
b. Increased Treatment for Patients
    Permitting practitioners to treat up to 275 patients will only be 
successful if it results in practitioners serving additional patients. 
As discussed previously, there are many reasons to expect this to 
happen as a result of the publication of this final rule. In addition, 
we expect that other factors could amplify the impact of the changes in 
the rule. First, following the implementation of the Affordable Care 
Act, health insurance coverage has expanded dramatically in the United 
States. The uninsured rate among adults age 18-64 declined from 22.3 
percent in 2010 to 12.7 percent during the first 6 months of 2015.\34\ 
Further, the Affordable Care Act expanded coverage includes populations 
who may be at high-risk for opioid use disorders that previously did 
not have sufficient access to health insurance coverage.\35\ Second, 
parity protections from the Mental Health Parity and Addiction Equity 
Act and the Affordable Care Act will include coverage for mental health 
and substance use disorder treatment that is comparable to medical and 
surgical coverage in many types of insurance policies. Insurance 
coverage and cost of treatment have previously been cited as important 
reasons that individuals seeking treatment have not used 
buprenorphine.36 37 38 39 A final rule to extend parity 
protections to Medicaid managed care plans was released earlier this 
year. These changes in health insurance coverage should improve access 
to substance use disorder treatment, including buprenorphine.
---------------------------------------------------------------------------

    \34\ Centers for Disease Control and Prevention. Health 
insurance coverage: early release of estimates from the National 
Health Interview Survey, January-June 2015. Available at: https://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201511.pdf.
    \35\ Jones, supra note 7.
    \36\ Volkow ND, Frieden TR, Hyde PS, et al. Medication-assisted 
therapies--tackling the opioid-overdose epidemic. New Eng J Med 
2014; 370(22):2063-6.
    \37\ Sohler NL, Weiss L, Egan JE, et al. Consumer attitudes 
about opioid addiction treatment: a focus group study in New York 
City. J Opioid Manag. 2013;9(2):111-119.
    \38\ Greenfield BL, Owens MD, Ley D. Opioid use in Albuquerque, 
New Mexico: a needs assessment of recent changes and treatment 
availability. Addict Sci Clin Pract. 2014;9:10. doi: 10.1186/1940-
0640-9-10.
    \39\ American Society of Addiction Medicine. State Medicaid 
coverage and authorization requirements for opioid dependence 
medications. 2013. Available at: https://www.asam.org/docs/advocacy/Implications-for-Opioid-Addiction-Treatment.
---------------------------------------------------------------------------

c. Increased Time To Treat Patients
    Lack of practitioner time to treat patients with opioid use 
disorder, which includes a patient exam, medication consultation, 
counseling, and other appropriate treatment services, and lack of 
behavioral health staff to provide these treatment services, are 
additional barriers to providing MAT with buprenorphine in the office-
based setting.40 41 These barriers could be addressed by 
leveraging the time and skills of clinical support staff, such as 
nurses and clinical social workers. For example, in Massachusetts and 
Vermont, nurses provide screening, intake, education, and other 
ancillary services for patients treated with buprenorphine. This 
enables practitioners to treat additional patients and to provide the 
requisite psychosocial services.42 43 44 However, in order 
to afford a nurse or other clinician dedicated to providing evidence-
based treatment for an opioid use disorder, practitioners need a 
minimum volume of patients. Allowing practitioners to treat up to 275 
patients at a time could be a step towards supporting practitioners 
that seek to hire nurses and other clinical staff to reduce 
practitioners' time requirements and to provide the comprehensive 
services of high-quality MAT with buprenorphine. This impact of 
leveraging non-physicians to facilitate expanded access to 
buprenorphine has been demonstrated in both Vermont and 
Massachusetts.45 46
---------------------------------------------------------------------------

    \40\ Hutchinson E, Catlin M, Andrilla CH, Baldwin LM, Rosenblatt 
RA. Barriers to primary care physicians prescribing buprenorphine. 
Ann Fam Med. 2014 Mar-Apr;12(2):128-33.
    \41\ DeFlavio JR, Rolin SA, Nordstrom BR, Kazal LA Jr. Analysis 
of barriers to adoption of buprenorphine maintenance therapy by 
family physicians. Rural Remote Health. 2015;15:3019. Epub 2015 Feb 
4.
    \42\ Alford D, LaBelle C, Richardson J, O'Connell J, et al. 
Treating homeless opioid dependent patients with buprenorphine in an 
office-based setting. Society of General Internal Medicine. 2007; 
22: 171-176.
    \43\ Labelle, C. Nurse Care Manager Model. https://buprenorphine.samhsa.gov/presentations/LaBelle.pdf.
    \44\ State of Vermont: Concept for Medicaid Health Home Program 
https://hcr.vermont.gov/sites/hcr/files/VT_SPA_Concept_Paper_final_CMS_10_02_12.pdf.
    \45\ LaBelle CT, Han SC, Bergeron A, Samet JH. Office-Based 
Opioid Treatment with Buprenorphine (OBOT-B): Statewide 
Implementation of the Massachusetts Collaborative Care Model in 
Community Health Centers. J Subst Abuse Treat. 2016;60:6-13.
    \46\ Vermont Department of Health. The effectiveness of 
Vermont's System of Opioid Addiction Treatment. 2015. Available at: 
https://legislature.vermont.gov/assets/Legislative-Reports/Opioid-system-effectiveness-1.14.15.pdf.
---------------------------------------------------------------------------

    Discussions with stakeholders about approaches to expanding access 
to MAT, including the use of buprenorphine-based MAT, suggest that 
expanding the patient limit in general will result in increased 
efficiencies in treating opioid use disorder patients. It will allow 
treating practitioners to provide the physician-appropriate services 
consistent with their waiver. It will provide more efficient supportive 
care, not related to prescribing or administering buprenorphine-
containing products, by allowing the treating practitioner to supervise 
this care, which can be provided by physician assistants, nurse 
practitioners, nurse case managers, and other behavioral health 
specialists.
d. Federal Costs Associated With Disseminating Information About the 
Rule
    Following publication of this final rule, SAMHSA will work to 
educate providers about the requirements and opportunities for 
requesting and obtaining approval to treat up to 275 patients under 21 
U.S.C. 823(g)(2). SAMHSA will prepare materials summarizing the changes 
as a result of

[[Page 44731]]

this final rule, and provide these materials to practitioners 
potentially affected by the rulemaking upon its publication. SAMHSA has 
already established channels for disseminating information about rule 
changes to stakeholders; it is estimated that preparing and 
disseminating these materials will cost approximately $40,000, based 
upon experience soliciting public comment on past rules and 
publications such as the Federal Opioid Treatment Program Standards.
e. Practitioners Costs To Evaluate the Policy Change
    We expect that practitioners potentially affected by this policy 
change will process the information and decide how to respond. In 
particular, they will likely evaluate the requirements and 
opportunities associated with the ability to treat up to 275 patients, 
and decide whether or not it is advantageous to pursue approval to 
treat up to 275 patients and make any necessary changes to their 
practice, such as obtaining additional credentialing as defined in 
Sec.  8.2, or the ability to treat patients in a qualified practice 
setting.
    We estimate that practitioners may spend an average of thirty 
minutes processing the information and deciding what action to take. 
According to the U.S. Bureau of Labor Statistics,\47\ the average 
hourly wage for a physician is $93.74. After adjusting upward by 100 
percent to account for overhead and benefits, we estimate that the per-
hour cost of a physician's time is $187.48. Thus, the cost per 
practitioner to process this information and decide upon a course of 
action is estimated to be $93.74. SAMHSA will disseminate information 
to an estimated 50,000 practitioners, which includes practitioners with 
a waiver to prescribe buprenorphine (i.e., approximately 30,000 
practitioners as of December 2015) and those who are reached through 
SAMHSA's dissemination network (i.e., 20,000 practitioners). For 
purposes of analysis we assume that 75 percent of these practitioners 
will review this information, and, as a result, we estimate that 
dissemination will result in a total cost of $3.5 million.
---------------------------------------------------------------------------

    \47\ U.S. Bureau of Labor Statistics. National Occupational 
Employment and Wage Estimates. Retrieved from: https://www.bls.gov/oes/current/oes_nat.htm#29-0000.
---------------------------------------------------------------------------

f. Practitioner Costs To Submit a Request for Patient Limit Increase
    Practitioners who want to treat up to 275 patients at a given time 
are required to submit a Request for Patient Limit Increase form to 
SAMHSA. The form is three pages in length. We estimate that the form 
takes a practitioner an average of 1 hour to complete the first time it 
is completed, implying a cost of $187.48 per submission after adjusting 
upward by 100 percent to account for overhead and benefits. A draft 
Request for Patient Limit Increase form is available in the docket. We 
did not receive public comment on these assumptions when proposed, and 
as a result they remain unchanged from those appearing in the proposed 
rule. We do not have ideal information with which to estimate the 
number of practitioners who will submit a Request for Patient Limit 
Increase form in response to this final rule, and we therefore 
acknowledge uncertainty regarding the estimate of the total associated 
cost. However, based on the experience with the patient limit increase 
from 30 to 100 implemented in 2007,48 49 the results of the 
2015 ASAM survey described earlier, public comment, and discussions 
with stakeholders, and changes in qualifications necessary to request a 
waiver to treat up to 275 patients, we estimate that between 500 and 
1,800 practitioners will request approval to treat up to 275 patients 
within the first year following publication of the final rule. This 
translates to between approximately 5 percent and 18 percent of 
eligible providers with the 100 patient limit requesting the higher 
patient limit in the first year. This is consistent with a public 
comment that indicated that 8 to 15 physicians (or 11 percent-
21percent) in Vermont would request the higher patient limit, as well 
as a recent study in Ohio which found among specialty treatment 
providers that 17 percent had turned away patients due to prescribing 
capacity limits.\50\ In addition, our lower bound estimate of 5 percent 
is in line with an internal analysis by HHS that found approximately 5 
percent of physicians with the 100 patient limit in 3 geographic 
diverse States were prescribing at or near their 100 patient limit. We 
estimate that between 100 and 300 additional practitioners will request 
approval to treat up to 275 patients in each of the subsequent 4 years. 
This would result in 600 to 2,100 practitioners in the second year, 700 
to 2,400 practitioners in the third year, 800 to 2,700 in the fourth 
year, and 900 to 3,000 practitioners in the fifth year. We use the 
midpoint of each of these ranges to estimate costs and benefits in the 
first 5 years following publication of the final rule. This would 
result in a range of $93,740 to $337,464 in costs related to Request 
for Patient Limit Increase submissions in the first year.
---------------------------------------------------------------------------

    \48\ Arfken CL, Johanson CE, Menza SD, Schuster CR. Expanding 
treatment capacity for opioid dependence with office-based treatment 
with buprenorphine: national surveys of physicians. J Subst Abuse 
Treat. 2010;39(2):96-104.
    \49\ Jones, supra note 24.
    \50\ Molfenter T, Sherbeck C, Zehner M, Starr S. Buprenorphine 
prescribing availability in a sample of Ohio specialty treatment 
organizations. J Addict Behav Ther Rehabil. 2015;4(2): doi:10.4172/
2324-9005.1000140.

------------------------------------------------------------------------
                                             Number of
                                           requests for
                                           patient limit     Cost ($)
                                             increase
------------------------------------------------------------------------
Year 1..................................           1,150         215,600
Year 2-5................................             200          37,500
                                         -------------------------------
    Total...............................           1,950         365,600
------------------------------------------------------------------------

g. Practitioner Costs To Resubmit a Request for Patient Limit Increase
    After approval, a practitioner would need to be resubmit a Request 
for Patient Limit Increase every 3 years to maintain his or her waiver 
to treat up to 275 patients. A practitioner would use the same 3-page 
Request for Patient Limit Increase used for an initial waiver request. 
We estimate that this will take 30 minutes because practitioners will 
be more familiar with the Request for Patient Limit Increase. 
Consistent with the physician wage estimate above, we estimate that 
resubmissions will require a practitioner an average of 30 minutes to 
complete, implying a cost of $93.74 per resubmission. To calculate 
costs associated with resubmission, we assume that all physicians who 
submit a Request for Patient Limit Increase will

[[Page 44732]]

submit a renewal 3 years later. Our estimates are summarized in the 
table below.

------------------------------------------------------------------------
                                             Number of
                                             renewals        Cost ($)
------------------------------------------------------------------------
Year 1-3 (renewals not necessary).......               0               0
Year 4..................................           1,150         108,000
Year 5..................................             200          19,000
                                         -------------------------------
    Total...............................           1,350         127,000
------------------------------------------------------------------------

h. Private-Sector Costs Associated With Newly Applying for Any Waiver
    Practitioners may also be interested in the ability to eventually 
treat up to 275 patients, and may make changes toward achieving that 
goal. As discussed previously, these changes may increase the number of 
practitioners who apply for a waiver to treat 30 or 100 patients. This 
would require practitioners to complete the required training, possess 
a valid license to practice medicine, be a registrant of DEA, and have 
the capacity to refer patients for appropriate counseling and other 
appropriate ancillary services. In addition, these changes could 
increase the number of practitioners who seek additional credentialing 
as defined in Sec.  8.2 or meet the requirements for practicing in a 
qualified practice setting as outlined in the final rule. This would 
likely include practice experience requirements, fees and time 
associated with preparing for and taking an exam, time and fees for 
continuing medical education requirements, and payment of certification 
fees. We lack information to estimate the number of practitioners who 
will change behavior along these dimensions, and did not receive this 
information through the public comment process. Thus, we do not provide 
estimates of costs and benefits.
i. Federal Costs Associated With Processing New 275-Patient Limit 
Waivers
    In addition to the costs associated with practitioners seeking 
approval for the higher patient limit, costs will be incurred by SAMHSA 
and DEA in order to process the additional Requests for Patient Limit 
Increase generated by the final rule. For purposes of analysis, and 
based on contractor estimates, SAMHSA estimates that it will pay a 
contractor $100 to process each waiver. As discussed previously, we 
estimate that between 500 and 1,800 practitioners will request approval 
to treat up to 275 patients within the first year of the rule, and 
between 100 and 300 additional practitioners will request approval to 
treat up to 275 patients in each of the subsequent 4 years. In 
addition, we estimate that physicians will resubmit 500 to 1,800 
renewals in year 4, and 100 to 300 renewals in year 5. As a result, we 
estimate costs to SAMHSA to process these waivers of $50,000-$180,000 
in year 1, $10,000-$30,000 in year 2, $10,000-$30,000 in year 3, 
$60,000-$210,000 in year 4, and $20,000-$60,000 in year 5 following 
publication of the final rule. We estimate that DEA will allocate the 
equivalent of 1 FTE at the GS-11 level to process the additional 
requests coming to DEA for issuance of a new DEA number designating the 
physician as eligible to prescribe buprenorphine for the treatment of 
opioid use disorder as a result of this final rule. We estimate the 
associated cost is $144,238, which we arrive at by multiplying the 
salary of a GS-11 employee at step 5, which is $72,219 in 2015, by two 
to account for overhead and benefits.
j. Costs and Benefits of New Treatment
    Once requests to treat up to 275 patients generated by the final 
rule are processed, approved practitioners would be able to increase 
the number of patients they treat with buprenorphine. These patients, 
then, could utilize additional medical services that are consistent 
with the expectations for high-quality, evidence-based MAT in the rule. 
We estimate the cost for buprenorphine and these additional medical 
services, including behavioral health and psychosocial services, as a 
result of the final rule to total $4,349 per patient per year, as 
described below.
    This estimate was derived using claims data from the 2009-2014 
Truven Health MarketScan[supreg] database. According to the 
MarketScan[supreg] data, the annual cost of buprenorphine prescriptions 
and ancillary psychosocial services received totaled $3,500 for 
individuals with private insurance and $3,410 for individuals with 
Medicaid. Specifically, the average annual cost of buprenorphine 
prescriptions was $2,100 for commercial insurance based on receipt of 
an average of seven buprenorphine prescriptions annually and $2,600 for 
Medicaid based on receipt of an average of 10 buprenorphine 
prescriptions annually. We use estimates from commercial insurance and 
Medicaid in order to capture the range of costs per patient across 
different insurance programs. However, we note that the rule will 
impact patients with and incur costs to not only commercial insurance 
and Medicaid but also other public and private insurers.
    According to the MarketScan[supreg] data, approximately 69 percent 
of Medicaid patients and 45 percent of privately insured patients 
received an outpatient psychosocial service related to substance use 
disorder in addition to their buprenorphine prescription. The average 
number of visits among those who received any psychosocial service was 
eight for privately insured patients at an average cost of $3,000 per 
year and 10 for Medicaid patients at an average cost of $1,100 per 
year. We assumed that the quality of care would increase among patients 
treated by practitioners with the 275-patient limit due to the extra 
oversight and quality of care requirements in the final rule. 
Specifically, we assumed that 80 percent of patients would receive 
outpatient psychosocial services.
    The cost of providing MAT with buprenorphine, including 
prescriptions, ancillary, and psychosocial services, is estimated at 
$4,590 for commercial insurance and $3,525 for Medicaid beneficiaries. 
Based on data from IMS Health, it is estimated that approximately 18 
percent of individuals receiving MAT with buprenorphine are Medicaid 
enrollees. Thus, we arrived at the estimated average cost for 
individuals new to the treatment system as a result of the final rule 
to be $4,350 per patient per year.
    The total resource costs associated with additional treatment is 
the product of additional treatment costs per person and the number of 
people who will receive additional treatment as a result of the final 
rule. For purposes of analysis, we assume that each practitioner who 
requests approval to treat up to 275 patients will treat between 20 and 
50 additional patients each year. This is based on the

[[Page 44733]]

experience with the increase from the 30 patient limit to the 100 
patient limit and taking into account the increase in demand for 
buprenorphine treatment since that statutory change.\51\ \52\ In 
addition, we have adjusted the upper bound of this range in line with 
the shift to the availability of a waiver to treat up to 275 rather 
than 200 patients. We note that in that case, there were no new costs 
imposed on practitioners beyond those associated with additional 
treatment, whereas in this final rule there are new costs beyond those 
associated with additional treatment. However, applying this assumption 
would result in an estimated range of 10,000 to 90,000 additional 
patients treated in the first year; and an additional 2,000 to 15,000 
patients in each subsequent year. To estimate costs associated with 
this increase in the number of patients, we assume that, on average, 
each physician will treat the equivalent of 35 full-time patients 
(i.e., some patients might receive fewer services and others might 
receive more, but for cost estimates we assume it averages out to the 
equivalent of 35 patients receiving the full spectrum of care). We use 
these ranges to estimate costs and benefits of the rule. Based on this 
information, we estimate the treatment costs associated with new 
patients receiving treatment with buprenorphine as a result of this 
final rule will be between $43.5 million and $391 million in the first 
year with a central estimate of $175 million, and an additional $8.7 
million to $65.2 million in each subsequent year with a central 
estimate of $30.4 million.\53\
---------------------------------------------------------------------------

    \51\ Arfken, supra note 48.
    \52\ Jones, supra note 24.
    \53\ As noted subsequently, some individuals newly receiving MAT 
would have accessed non-MAT interventions in the absence of this 
rule. Accounting for this would reduce the estimates of rule-induced 
costs.

------------------------------------------------------------------------
                                       Additional people
                                           receiving         Treatment
                                           treatment,          costs
                                          relative to       (millions)
                                            baseline
------------------------------------------------------------------------
Year 1...............................             40,250            $175
Year 2...............................             47,250             205
Year 3...............................             54,250             236
Year 4...............................             61,250             266
Year 5...............................             68,250             297
------------------------------------------------------------------------

    Evidence suggests that the benefits associated with additional 
buprenorphine utilization are likely to exceed their cost. One study 
estimates the costs and Quality Adjusted Life Year (QALY) gains 
associated with long-term office-based treatment with buprenorphine-
naloxone for clinically stable opioid-dependent patients compared to no 
treatment. The authors estimate total treatment costs over 2 years of 
$7,700 and an associated 0.22 QALY gain compared to no treatment in 
their base case.\54\ \55\ Following a food safety rule recently 
published by FDA,\56\ we use a value of $1,260 per quality-adjusted 
life day. This implies a value of $460,215 ($1,260 * 365.25) per QALY, 
which we use to monetize the health benefits here. As a result, we 
estimate average annual benefits ranges of $51,000 per person who 
achieves 6 months of clinical stability. Evidence suggests a 43.3 
percent completion rate for a six month treatment course.\57\ For other 
individuals, we estimate they experience half of the annual health 
benefits, equivalent to 0.055 QALYs. In addition, based on an internal 
analysis of data from the National Survey on Drug Use and Health, we 
estimate that 20 percent of new patients impacted by this rule will 
have received some form of non-medication-assisted treatment for opioid 
use disorder in the past year and 80 percent of patients will be new to 
treatment.\58\ For the 20 percent of patients switching to 
buprenorphine from other non-MAT interventions, we adjust their 
estimated health benefit downward by 15 percent to account for benefits 
derived from non-MAT interventions prior to initiating buprenorphine 
treatment. As a result, we estimate monetized health benefits of $1,416 
million in the first year, with estimated monetized health benefits 
rising by $246 million in each subsequent year as more individuals 
receive treatment as a result of the rule. These monetized health 
benefits are summarized below. We also explore the sensitivity of these 
results to our assumptions regarding the health benefits related to 
treatment in our section on sensitivity analysis. HHS believes that the 
public will also experience benefits that go beyond the health benefits 
quantified and monetized here. These benefits include reductions in 
costs associated with criminal justice system interactions. While these 
are important benefits of this rule, HHS does not quantify the rule's 
effects along these dimensions.
---------------------------------------------------------------------------

    \54\ Schackman BR, Leff JA, Polsky D, Moore BA, Fiellin DA. 
Cost-Effectiveness of Long-Term Outpatient Buprenorphine-Naloxone 
Treatment for Opioid Dependence in Primary Care. Journal of General 
Internal Medicine. 2012;27(6):669-676. doi:10.1007/s11606-011-1962-
8.
    \55\ These results omit lost utility associated with the illegal 
consumption of heroin or other opioids. Such omission is consistent 
with Zerbe, R.O. Is Cost-Benefit Analysis Legal? Three Rules. 
Journal of Policy Analysis and Management 17(3): 419-456, 1998.
    \56\ This RIA can be found here: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472330.pdf.
    \57\ Fiellin DA, Pantalon MV, Chawarski MC, Moore BA, Sullivan 
LE, O'Connor PG, Schottenfeld RS. Counseling plus Buprenorphine--
Naloxone Maintenance Therapy for Opioid Dependence. New England 
Journal of Medicine. 2006; 355:365-374. doi: 10.1056/NEJMoa055255
    \58\ Given that data from the National Survey on Drug Use and 
Health indicate only a minority of patients with substance use 
disorder treatment need actually recognize that need and seek 
treatment, we note that 20 percent likely represents the lower bound 
of the portion of new MAT recipients who would have received some 
form of non-MAT treatment in the absence of the rule, thus leading 
to some tendency in the benefits to be overestimated.

------------------------------------------------------------------------
                                       Additional people
                                           receiving         Monetized
                                           treatment,         health
                                          relative to        benefits
                                            baseline        (millions)
------------------------------------------------------------------------
Year 1...............................             40,250          $1,416
Year 2...............................             47,250           1,662
Year 3...............................             54,250           1,909

[[Page 44734]]

 
Year 4...............................             61,250           2,155
Year 5...............................             68,250           2,431
------------------------------------------------------------------------

k. Potential for Diversion
    While we expect many benefits associated with this final rule, it 
is possible that there would be unintended negative consequences. 
First, prior research looked at Utah statewide increases in 
buprenorphine use and the number of reported unintentional pediatric 
exposures, and found that as buprenorphine use increased between 2002 
and 2011, the number of unintentional pediatric exposures in the State 
increased.\59\ Thus, it is possible that the increased utilization of 
buprenorphine as a result of this final rule without appropriate 
patient counseling and action to ensure the safe use, storage, and 
disposal of buprenorphine, may lead to an increase in unintentional 
pediatric exposures. In addition, there has been an increase in 
diversion of buprenorphine as use of the product has increased. 
According to the National Forensic Laboratory Information System 
(NFLIS)--a system used to track diversion--buprenorphine is the third 
most common narcotic analgesic reported in NFLIS, with 15,209 cases 
reported in 2014. This represents 12.4 percent of all narcotic 
analgesic cases in NFLIS in 2014.\60\
---------------------------------------------------------------------------

    \59\ Centers for Disease Control and Prevention. Buprenorphine 
prescribing practices and exposures reported to a poison center--
Utah, 2002-2011. MMWR 2012;61:997-1001.
    \60\ Drug Enforcement Administration. National Forensic 
Laboratory Information System. 2014 Annual Report. Available at: 
https://www.nflis.deadiversion.usdoj.gov/Reports.aspx.
---------------------------------------------------------------------------

    It is important to note that studies have found that the motivation 
to divert buprenorphine is often associated with lack of access to 
treatment or using the medication to manage withdrawal--as opposed to 
diversion for the medication's psychoactive effect.61 
62 Thus, the overall effect of this rulemaking on diversion 
is not clear given that the increased utilization of buprenorphine 
could affect the opportunity for diversion, but also could, in some 
cases, reduce diversion because of improved access to high-quality, 
evidence-based buprenorphine treatment.
---------------------------------------------------------------------------

    \61\ Lofwall MR, Havens JR. Inability to access buprenorphine 
treatment as a risk factor for using diverted buprenorphine. Drug 
Alcohol Depend. 2012;126(3):379-83.
    \62\ Genberg BL, Gillespie M, Schuster CR, Johanson CE, et al. 
Prevalence and correlates of street-obtained buprenorphine use among 
current and former injectors in Baltimore, Maryland. Addict Behav. 
2013;38(12):2868-73.
---------------------------------------------------------------------------

    Moreover, to reduce the risk of diversion, one of the additional 
requirements placed on providers who seek the 275-patient limit is 
implementation of a diversion control plan. However, it is possible 
that State and local law enforcement could incur additional costs if 
diversion increases as a result of this final rule. We do not have 
sufficient information to estimate the extent to which these unintended 
consequences could occur, and did not receive any through public 
comment.
l. Practitioner Reporting Requirements
    As discussed elsewhere in the preamble, HHS has decided to issue 
concurrently a Supplemental Notice of Proposed Rulemaking to seek 
additional comments on the proposed reporting requirements and is 
therefore delaying the finalization of the reporting requirements 
proposed in Sec.  8.635 of the NPRM. At this time, we lack the 
information necessary to estimate the costs associated with future 
reporting requirements, and as a result do not estimate them here.
m. Costs Associated With Waiver Requests in Emergencies
    Under the final rule, practitioners in good standing with a current 
waiver to treat up to 100 patients may request temporary approval to 
treat up to 275 patients in specific emergency situations. As discussed 
previously, we anticipate that qualifying emergency situations will 
occur very infrequently. We estimate that practitioners will request 
ten of these waivers in each year. We estimate that requesting this 
waiver would require approximately 1 hour of physician time and 2 hours 
of administrative time, and responding to the request would require 
resources approximately equivalent to responding the three Requests for 
Patient Limit Increase submissions, which is $300. As a result, we 
estimate that this requirement is associated with costs of 
approximately $7,000 in each year following publication of the final 
rule.
n. Summary of Impacts
    The final rule's impacts will take place over a long period of 
time. As discussed previously, we expect the existence of the waiver to 
treat up to 275 patients will increase the desirability of waivers to 
treat 30 and 100 patients. This implies that more practitioners will 
work toward fulfilling the requirements associated with receiving these 
waivers. Further, this may make practitioners early in their career 
more likely to choose addiction medicine or addiction psychiatry as 
their specialty. All of this implies that the final rule will have a 
growing impact on capacity to prescribe buprenorphine as time passes. 
Since the lack of capacity to treat patients using buprenorphine is a 
barrier to its utilization, this suggests that the final rule will lead 
to growing increases in the utilization of buprenorphine, and growing 
increases in the associated positive health and economic effects.
    The following table presents these costs and benefits over the 
first 5 years of the final rule.

                              Accounting Table of Benefits and Costs of All Changes
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                   Present value over 5 years
                                   by discount rate
                                   (millions of 2014 dollars)
                                   Annualized value over 5 years
                                   by discount rate
                                   (millions of 2014 dollars)
----------------------------------------------------------------------------------------------------------------
BENEFITS                          3 Percent           7 Percent           3 Percent           7 Percent
                                 -------------------------------------------------------------------------------
    Quantified Benefits.........  8,935.............  8,228.............  1,894.............  1,875
                                 -------------------------------------------------------------------------------

[[Page 44735]]

 
COSTS                             3 Percent           7 Percent           3 Percent           7 Percent
                                 -------------------------------------------------------------------------------
    Quantified Costs............  1,109.............  1,022.............  235...............  233
----------------------------------------------------------------------------------------------------------------

E. Sensitivity Analysis

    The total estimated benefits of the changes here are sensitive to 
assumptions regarding the number of practitioners who will seek a 
waiver to treat up to 275 patients as a result of the final rule, the 
number of individuals who will receive MAT as a result of the final 
rule, the average per-person health benefits associated with this 
additional treatment, and the dollar value of these health 
improvements. We estimate that 500 to 1,800 practitioners will apply 
for a waiver to treat up to 275 patients in the first year, and 100 to 
300 practitioners will apply for a waiver to treat up to 275 patients 
in subsequent years following publication of the final rule, with 
central estimates at the midpoint of each range. For alternative 
estimates in these ranges using a 3 percent discount rate, all else 
equal, we estimate annualized benefits ranging from $855 million to 
$2,934 million and annualized costs ranging from $107 million to $364 
million.
    We estimate that practitioners who receive a waiver to treat up to 
275 patients will treat between 20 and 50 additional patients each 
year, with a central estimate of an average of 35 additional patients. 
For alternative estimates of 20 to 50 additional patients per year, all 
else equal, we estimate annualized benefits using a 3 percent discount 
rate ranging from $1,082 million to $2,706 million and annualized costs 
ranging from $135 million to $336 million over the 5 years following 
implementation.
    We estimate that individuals who receive MAT as a result of the 
final rule will experience average health improvements equivalent to 
approximately 0.08 QALYs. For alternative estimates of these health 
improvements between 0.04 and 0.12 QALYs, all else equal, we estimate 
annualized benefits using a 3 percent discount rate ranging from $991 
million to $2,973 million over the 5 years following implementation. To 
estimate the dollar value of health benefits, we use a value of 
approximately $460,000 per QALY. For alternative values per QALY 
between $300,000 and $600,000, all else equal, we estimate annualized 
benefits using a 3 percent discount rate ranging from $1,235 million to 
$2,469 million over the 5 years following implementation.
    Alternative assumptions along these four dimensions, when varied 
together, using a 3 percent discount rate, imply annualized benefit 
estimates ranging from $167 million to $8,576 million and annualized 
cost estimates ranging from $61 million to $519 million. We note that, 
in all scenarios discussed in this section, annualized benefits 
substantially exceed annualized costs. There are, however, 
uncertainties not reflected in this sensitivity analysis, which might 
lead to net benefits results that are smaller or larger than the range 
of estimates summarized in the following table.

                                Low, High, and Primary Benefit and Cost Estimates
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                                                Annualized value over 5 years
                                                                3 percent discount rate
                                                                (millions of 2014 dollars)
----------------------------------------------------------------------------------------------------------------
BENEFITS                                                                  Low          Primary             High
                                                              --------------------------------------------------
    Quantified Benefits......................................             167            1,894            8,576
                                                              --------------------------------------------------
COSTS                                                                     Low          Primary             High
                                                              --------------------------------------------------
    Quantified Costs.........................................              61              235              519
----------------------------------------------------------------------------------------------------------------

F. Analysis of Regulatory Alternatives

    We carefully considered the option of not pursuing regulatory 
action. However, existing evidence indicates that opioid use disorder 
and its related health consequences is a substantial and increasing 
public health problem in the United States, and it can be addressed by 
increasing access to effective treatment. As discussed previously, the 
lack of sufficient access to treatment is directly affected by the 
existing limit on the number of patients each practitioner with a 
waiver can currently treat using buprenorphine, and removing this 
barrier to access is very likely to increase the provision of this 
treatment. Finally, the provision of MAT with buprenorphine provides 
tremendous benefits to the individual who experiences health gains 
associated with treatment, as well as to society which bears smaller 
costs associated with the negative effects of opioid use disorders. 
These benefits are expected to greatly exceed the costs associated with 
increases in treatment. As a result, we expect the benefits of this 
regulatory action to exceed its costs.
    We also considered allowing practitioners waivered to treat up to 
100 patients to apply for the higher prescribing limit without having 
to meet the additional credentialing as defined in Sec.  8.2 or 
qualified practice setting requirements as defined in the final rule. 
One important objective of this final rule is to expand access while 
mitigating the risks associated with expanded access. In addition, the 
effects of this rule are difficult to project, leading us to adopt a 
measured approach to increasing access. Given the complexity of the 
condition, the increased potential for diversion associated with a 
higher prescribing limit, and the need to ensure high quality care, it 
was determined that addiction specialist physicians and those with the 
infrastructure and capacity to deliver the full complement of services 
recommended by clinical practice guidelines would be best suited to 
balance these concerns.
    Finally, we considered the alternative of having no reporting 
requirement for physicians with the 275-patient limit. Although this 
alternative would reduce the 1 hour of physician time and 2 hours of 
administrative time estimated

[[Page 44736]]

for data reporting in our analysis, we did not pursue this alternative. 
The reporting requirements are intended to reinforce recommendations 
included in clinical practice guidelines on the delivery of high 
quality, effective, and safe patient care. Specifically, nationally-
recognized clinical guidelines on office-based opioid treatment with 
buprenorphine suggest that optimal care include administration of the 
medication and the use of psychotherapeutic support services. They also 
recommend that physicians and practices prescribing buprenorphine for 
the treatment of opioid use disorder in the outpatient setting take 
steps to reduce the likelihood of buprenorphine diversion. Each of 
these tenets is reflected in the reporting requirements.

G. Regulatory Flexibility Analysis

    As discussed above, the RFA requires agencies that issue a 
regulation to analyze options for regulatory relief of small entities 
if a rule has a significant impact on a substantial number of small 
entities. The categories of entities affected most by this final rule 
will be offices of practitioners and hospitals. We expect that the vast 
majority of these entities will be considered small based on the Small 
Business Administration size standards or non-profit status, and assume 
here that all affected entities are small. According to SAMHSA data, as 
of March 2016, there were 32,123 practitioners with a waiver to 
prescribe buprenorphine for the treatment of opioid use disorder. This 
group of practitioners is most likely to be impacted by the final rule, 
but we lack information on the total number of associated entities. We 
acknowledge that some practitioners with a waiver may provide services 
at multiple entities, many entities may employ multiple practitioners 
with a waiver, and some entities currently unaffiliated with these 
practitioners will be impacted by this final rule. As a result, we 
estimate that approximately 32,123 small entities will be affected by 
this final rule.
    HHS considers a rule to have a significant economic impact on a 
substantial number of small entities if at least 5 percent of small 
entities experience an impact of more than 3 percent of revenue. As 
discussed above, the final rule imposes a small burden on entities. 
This burden is primarily associated with processing information 
disseminated by SAMHSA, opting to completing the waiver process to 
treat additional patients, and submitting information after receiving a 
waiver to treat 275 patients, which are estimated to take a maximum of 
4 hours per practitioner in any given year. This represents less than 1 
percent of hours worked for an individual working full-time. Further, 
this final rule does not require practitioners to undertake these 
burdens, as this rulemaking does not require practitioners to seek a 
waiver to treat 275 patients. As a result, we anticipate that this 
final rule will not have a significant impact on a substantial number 
of small entities.

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. Revise the heading of part 8 as set forth above.

0
3. Amend part 8 as follows:
0
a. Remove the word ``opiate'' and add the word ``opioid'' in its place 
wherever it appears; and
0
b. Remove the phrases ``opioid addiction'' and ``Opioid addiction'' and 
add in their places the phrases ``opioid use disorder'' and ``Opioid 
use disorder'', respectively, wherever they appear.

0
4. Revise the heading to subpart A to read as follows:

Subpart A--General Provisions

0
5. Revise Sec.  8.1 to read as follows:


Sec.  8.1  Scope.

    (a) Subparts A through C of this part establish the procedures by 
which the Secretary of Health and Human Services (the Secretary) will 
determine whether a practitioner is qualified under section 303(g) of 
the Controlled Substances Act (CSA) (21 U.S.C. 823(g)) to dispense 
opioid drugs in the treatment of opioid use disorders. The regulations 
also establish the Secretary's standards regarding the appropriate 
quantities of opioid drugs that may be provided for unsupervised use by 
individuals undergoing such treatment (21 U.S.C. 823(g)(1)). Under 
these regulations, a practitioner who intends to dispense opioid drugs 
in the treatment of opioid use disorder must first obtain from the 
Secretary or, by delegation, from the Administrator, Substance Abuse 
and Mental Health Services Administration (SAMHSA), a certification 
that the practitioner is qualified under the Secretary's standards and 
will comply with such standards. Eligibility for certification will 
depend upon the practitioner obtaining accreditation from an 
accreditation body that has been approved by SAMHSA. These regulations 
establish the procedures whereby an entity can apply to become an 
approved accreditation body. This part also establishes requirements 
and general standards for accreditation bodies to ensure that 
practitioners are consistently evaluated for compliance with the 
Secretary's standards for treatment of opioid use disorder with an 
opioid agonist treatment medication.
    (b) The regulations in subpart F of this part establish the 
procedures and requirements that practitioners who are authorized to 
treat up to 100 patients pursuant to a waiver obtained under section 
303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy in order to 
treat up to 275 patients with medications covered under section 
303(g)(2)(C) of the CSA.

0
6. Amend Sec.  8.2 as follows:
0
a. Revise the definitions of ``Accreditation body'' and ``Accreditation 
body application'';
0
b. Add, in alphabetical order, the definitions of ``Additional 
Credentialing,'' ``Approval term,'' and ``Behavioral health services'';
0
c. Add, in alphabetical order, the definitions of ``Covered 
medications,'' ``Dispense,'' ``Diversion control plan,'' and 
``Emergency situation'';
0
d. Revise the definition of ``Interim maintenance treatment'';
0
e. Add, in alphabetical order, the definitions of ``Medication-Assisted 
Treatment (MAT),'' ``Nationally recognized evidence-based guidelines,'' 
and ``Opioid dependence'';
0
f. Remove the definition of ``Opioid treatment'';
0
g. Revise the definitions of ``Opioid treatment program'';
0
h. Add, in alphabetical order, the definitions of ``Opioid program 
treatment certification,'' ``Opioid use disorder,'' and ``Opioid use 
disorder treatment'';
0
i. Revise the definition of ``Patient'';
0
j. Add, in alphabetical order, the definitions of ``Patient limit,'' 
``Practitioner,'' and ``Practitioner incapacity''; and
0
k. Remove the definition of ``Registered opioid treatment program''.
    The revisions and additions read as follows:

[[Page 44737]]

Sec.  8.2  Definitions.

* * * * *
    Accreditation body means a body that has been approved by SAMHSA in 
this part to accredit opioid treatment programs using opioid agonist 
treatment medications.
    Accreditation body application means the application filed with 
SAMHSA for purposes of obtaining approval as an accreditation body.
* * * * *
    Additional Credentialing means board certification in addiction 
medicine or addiction psychiatry by the American Board of Addiction 
Medicine or the American Board of Medical Specialties or certification 
by the American Osteopathic Academy of Addiction Medicine, the American 
Board of Addiction Medicine, or the American Society of Addiction 
Medicine.
    Approval term means the 3 year period in which a practitioner is 
approved to treat up to 275 patients that commences when a 
practitioner's Request for Patient Limit Increase is approved in 
accordance with Sec.  8.625.
    Behavioral health services means any non-pharmacological 
intervention carried out in a therapeutic context at an individual, 
family, or group level. Interventions may include structured, 
professionally administered interventions (e.g., cognitive behavior 
therapy or insight oriented psychotherapy) delivered in person, 
interventions delivered remotely via telemedicine shown in clinical 
trials to facilitate medication-assisted treatment (MAT) outcomes, or 
non-professional interventions.
* * * * *
    Covered medications means the drugs or combinations of drugs that 
are covered under 21 U.S.C. 823(g)(2)(C).
* * * * *
    Dispense means to deliver a controlled substance to an ultimate 
user by, or pursuant to, the lawful order of, a practitioner, including 
the prescribing and administering of a controlled substance.
    Diversion control plan means a set of documented procedures that 
reduce the possibility that controlled substances will be transferred 
or used illicitly.
    Emergency situation means that an existing State, tribal, or local 
system for substance use disorder services is overwhelmed or unable to 
meet the existing need for medication-assisted treatment as a direct 
consequence of a clear precipitating event. This precipitating event 
must have an abrupt onset, such as practitioner incapacity; natural or 
human-caused disaster; an outbreak associated with drug use; and result 
in significant death, injury, exposure to life-threatening 
circumstances, hardship, suffering, loss of property, or loss of 
community infrastructure.
* * * * *
    Interim maintenance treatment means maintenance treatment provided 
in an opioid treatment program in conjunction with appropriate medical 
services while a patient is awaiting transfer to a program that 
provides comprehensive maintenance treatment.
* * * * *
    Medication-Assisted Treatment (MAT) means the use of medication in 
combination with behavioral health services to provide an 
individualized approach to the treatment of substance use disorder, 
including opioid use disorder.
    Nationally recognized evidence-based guidelines means a document 
produced by a national or international medical professional 
association, public health agency, such as the World Health 
Organization, or governmental body with the aim of assuring the 
appropriate use of evidence to guide individual diagnostic and 
therapeutic clinical decisions.
* * * * *
    Opioid dependence means repeated self-administration that usually 
results in opioid tolerance, withdrawal symptoms, and compulsive drug-
taking. Dependence may occur with or without the physiological symptoms 
of tolerance and withdrawal.
* * * * *
    Opioid treatment program or ``OTP'' means a program or practitioner 
engaged in opioid treatment of individuals with an opioid agonist 
treatment medication registered under 21 U.S.C. 823(g)(1).
    Opioid treatment program certification means the process by which 
SAMHSA determines that an opioid treatment program is qualified to 
provide opioid treatment under the Federal opioid treatment standards 
described in Sec.  8.12.
    Opioid use disorder means a cluster of cognitive, behavioral, and 
physiological symptoms in which the individual continues use of opioids 
despite significant opioid-induced problems.
    Opioid use disorder treatment means the dispensing of an opioid 
agonist treatment medication, along with a comprehensive range of 
medical and rehabilitative services, when clinically necessary, to an 
individual to alleviate the adverse medical, psychological, or physical 
effects incident to an opioid use disorder. This term includes a range 
of services including detoxification treatment, short-term 
detoxification treatment, long-term detoxification treatment, 
maintenance treatment, comprehensive maintenance treatment, and interim 
maintenance treatment.
    Patient for purposes of subparts B through E of this part, means 
any individual who receives maintenance or detoxification treatment in 
an opioid treatment program. For purposes of subpart F of this part, 
patient means any individual who is dispensed or prescribed covered 
medications by a practitioner.
    Patient limit means the maximum number of individual patients that 
a practitioner may dispense or prescribe covered medications to at any 
one time.
    Practitioner means a physician who is appropriately licensed by the 
State to dispense covered medications and who possesses a waiver under 
21 U.S.C. 823(g)(2).
    Practitioner incapacity means the inability of a practitioner as a 
result of an involuntary event to physically or mentally perform the 
tasks and duties required to provide medication-assisted treatment in 
accordance with nationally recognized evidence-based guidelines.
* * * * *

0
7. Amend Sec.  8.3 by revising the introductory text of paragraph (b) 
to read as follows:


Sec.  8.3  Application for approval as an accreditation body.

* * * * *
    (b) Application for initial approval. Electronic copies of an 
accreditation body application form [SMA-167] shall be submitted to: 
https://buprenorphine.samhsa.gov/pls/bwns/waiver. Accreditation body 
applications shall include the following information and supporting 
documentation:
* * * * *
Subpart C [Redesignated as Subpart D]

0
8. Redesignate subpart C, consisting of Sec. Sec.  8.21 through 8.34, 
as subpart D and revise the heading to read as follows:

Subpart D--Procedures for Review of Suspension or Proposed 
Revocation of OTP Certification, and of Adverse Action Regarding 
Withdrawal of Approval of an Accreditation Body

Subpart B [Redesignated as Subpart C]

0
9. Redesignate subpart B, consisting of Sec. Sec.  8.11 through 8.15, 
as subpart C and revise the heading to read as follows:

[[Page 44738]]

Subpart C--Certification and Treatment Standards for Opioid 
Treatment Programs

0
10. Add a heading for new subpart B to read as follows:

Subpart B--Accreditation of Opioid Treatment Programs


Sec. Sec.  8.3, 8.4, 8.5, and 8.6  [Transferred to Subpart B]

0
11. Transfer Sec. Sec.  8.3, 8.4, 8.5, and 8.6 to new subpart B.

Subpart E [Reserved]

0
12. Add reserved subpart E.

0
13. Add subpart F, consisting of Sec. Sec.  8.610 through 8.655, to 
read as follows:

Subpart F--Authorization To Increase Patient Limit to 275 Patients

Sec.
8.610 Which practitioners are eligible for a patient limit of 275?
8.615 What constitutes a qualified practice setting?
8.620 What is the process to request a patient limit of 275?
8.625 How will a Request for Patient Limit Increase be processed?
8.630 What must practitioners do in order to maintain their approval 
to treat up to 275 patients?
8.635 [Reserved]
8.640 What is the process for renewing a practitioner's Request for 
Patient Limit Increase approval?
8.645 What are the responsibilities of practitioners who do not 
submit a renewal Request for Patient Limit Increase, or whose 
renewal request is denied?
8.650 Can SAMHSA's approval of a practitioner's Request for Patient 
Limit Increase be suspended or revoked?
8.655 Can a practitioner request to temporarily treat up to 275 
patients in emergency situations?

Subpart F--Authorization To Increase Patient Limit to 275 Patients


Sec.  8.610  Which practitioners are eligible for a patient limit of 
275?

    The total number of patients that a practitioner may dispense or 
prescribe covered medications to at any one time for purposes of 21 
U.S.C. 823(g)(2)(B)(iii) is 275 if:
    (a) The practitioner possesses a current waiver to treat up to 100 
patients under section 303(g)(2) of the Controlled Substances Act (21 
U.S.C. 823(g)(2)) and has maintained the waiver in accordance with 
applicable statutory requirements without interruption for at least one 
year since the practitioner's notification of intent (NOI) under 
section 303(g)(2)(B) to treat up to 100 patients was approved;
    (b) The practitioner:
    (1) Holds additional credentialing as defined in Sec.  8.2; or
    (2) Provides medication-assisted treatment (MAT) utilizing covered 
medications in a qualified practice setting as defined in Sec.  8.615;
    (c) The practitioner has not had his or her enrollment and billing 
privileges in the Medicare program revoked under Sec.  424.535 of this 
title; and
    (d) The practitioner has not been found to have violated the 
Controlled Substances Act pursuant to 21 U.S.C. 824(a).


Sec.  8.615  What constitutes a qualified practice setting?

    A qualified practice setting is a practice setting that:
    (a) Provides professional coverage for patient medical emergencies 
during hours when the practitioner's practice is closed;
    (b) Provides access to case-management services for patients 
including referral and follow-up services for programs that provide, or 
financially support, the provision of services such as medical, 
behavioral, social, housing, employment, educational, or other related 
services;
    (c) Uses health information technology (health IT) systems such as 
electronic health records, if otherwise required to use these systems 
in the practice setting. Health IT means the electronic systems that 
health care professionals and patients use to store, share, and analyze 
health information;
    (d) Is registered for their State prescription drug monitoring 
program (PDMP) where operational and in accordance with Federal and 
State law. PDMP means a statewide electronic database that collects 
designated data on substances dispensed in the State. For practitioners 
providing care in their capacity as employees or contractors of a 
Federal government agency, participation in a PDMP is required only 
when such participation is not restricted based on their State of 
licensure and is in accordance with Federal statutes and regulations;
    (e) Accepts third-party payment for costs in providing health 
services, including written billing, credit, and collection policies 
and procedures, or Federal health benefits.


Sec.  8.620  What is the process to request a patient limit of 275?

    In order for a practitioner to receive approval for a patient limit 
of 275, a practitioner must meet all of the requirements specified in 
Sec.  8.610 and submit a Request for Patient Limit Increase to SAMHSA 
that includes all of the following:
    (a) Completed Request for Patient Limit Increase form;
    (b) Statement certifying that the practitioner:
    (1) Will adhere to nationally recognized evidence-based guidelines 
for the treatment of patients with opioid use disorders;
    (2) Will provide patients with necessary behavioral health services 
as defined in Sec.  8.2 or through an established formal agreement with 
another entity to provide behavioral health services;
    (3) Will provide appropriate releases of information, in accordance 
with Federal and State laws and regulations, including the Health 
Information Portability and Accountability Act Privacy Rule (45 CFR 
part 160 and 45 CFR part 164, subparts A and E) and 42 CFR part 2, if 
applicable, to permit the coordination of care with behavioral health, 
medical, and other service practitioners;
    (4) Will use patient data to inform the improvement of outcomes;
    (5) Will adhere to a diversion control plan to manage the covered 
medications and reduce the possibility of diversion of covered 
medications from legitimate treatment use;
    (6) Has considered how to assure continuous access to care in the 
event of practitioner incapacity or an emergency situation that would 
impact a patient's access to care as defined in Sec.  8.2; and
    (7) Will notify all patients above the 100 patient level, in the 
event that the request for the higher patient limit is not renewed or 
the renewal request is denied, that the practitioner will no longer be 
able to provide MAT services using buprenorphine to them and make every 
effort to transfer patients to other addiction treatment;
    (c) Any additional documentation to demonstrate compliance with 
Sec.  8.610 as requested by SAMHSA.


Sec.  8.625  How will a Request for Patient Limit Increase be 
processed?

    (a) Not later than 45 days after the date on which SAMHSA receives 
a practitioner's Request for Patient Limit Increase as described in 
Sec.  8.620, or renewal Request for Patient Limit Increase as described 
in Sec.  8.640, SAMHSA shall approve or deny the request.
    (1) A practitioner's Request for Patient Limit Increase will be 
approved if the practitioner satisfies all applicable requirements 
under Sec. Sec.  8.610 and 8.620. SAMHSA will thereafter notify the

[[Page 44739]]

practitioner who requested the patient limit increase, and the Drug 
Enforcement Administration (DEA), that the practitioner has been 
approved to treat up to 275 patients using covered medications. A 
practitioner's approval to treat up to 275 patients under this section 
will extend for a term not to exceed 3 years.
    (2) SAMHSA may deny a practitioner's Request for Patient Limit 
Increase if SAMHSA determines that:
    (i) The Request for Patient Limit Increase is deficient in any 
respect; or
    (ii) The practitioner has knowingly submitted false statements or 
made misrepresentations of fact in the practitioner's Request for 
Patient Limit Increase.
    (b) If SAMHSA denies a practitioner's Request for Patient Limit 
Increase (or renewal), SAMHSA shall notify the practitioner of the 
reasons for the denial.
    (c) If SAMHSA denies a practitioner's Request for Patient Limit 
Increase (or renewal) based solely on deficiencies that can be 
resolved, and the deficiencies are resolved to the satisfaction of 
SAMHSA in a manner and time period approved by SAMHSA, the 
practitioner's Request for Patient Limit Increase will be approved. If 
the deficiencies have not been resolved to the satisfaction of SAMHSA 
within the designated time period, the Request for Patient Limit 
Increase may be denied.


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

    (a) A practitioner whose Request for Patient Limit Increase is 
approved in accordance with Sec.  8.625 shall maintain all eligibility 
requirements specified in Sec.  8.610, and all attestations made in 
accordance with Sec.  8.620(b), during the practitioner's 3-year 
approval term. Failure to do so may result in SAMHSA withdrawing its 
approval of a practitioner's Request for Patient Limit Increase.
    (b) [Reserved]


Sec.  8.635  [Reserved]


Sec.  8.640  What is the process for renewing a practitioner's Request 
for Patient Limit Increase approval?

    (a) Practitioners who intend to continue to treat up to 275 
patients beyond their current 3 year approval term must submit a 
renewal Request for Patient Limit Increase in accordance with the 
procedures outlined under Sec.  8.620 at least 90 days before the 
expiration of their approval term.
    (b) If SAMHSA does not reach a final decision on a renewal Request 
for Patient Limit Increase before the expiration of a practitioner's 
approval term, the practitioner's existing approval term will be deemed 
extended until SAMHSA reaches a final decision.


Sec.  8.645  What are the responsibilities of practitioners who do not 
submit a renewal Request for Patient Limit Increase, or whose renewal 
request is denied?

    Practitioners who are approved to treat up to 275 patients in 
accordance with Sec.  8.625, but who do not renew their Request for 
Patient Limit Increase, or whose renewal request is denied, shall 
notify, under Sec.  8.620(b)(7) in a time period specified by SAMHSA, 
all patients affected above the 100 patient limit, that the 
practitioner will no longer be able to provide MAT services using 
covered medications and make every effort to transfer patients to other 
addiction treatment.


Sec.  8.650  Can SAMHSA's approval of a practitioner's Request for 
Patient Limit Increase be suspended or revoked?

    (a) SAMHSA, at any time during a practitioner's 3 year approval 
term, may suspend or revoke its approval of a practitioner's Request 
for Patient Limit Increase under Sec.  8.625 if it is determined that:
    (1) Immediate action is necessary to protect public health or 
safety;
    (2) The practitioner made misrepresentations in the practitioner's 
Request for Patient Limit Increase;
    (3) The practitioner no longer satisfies the requirements of this 
subpart; or
    (4) The practitioner has been found to have violated the CSA 
pursuant to 21 U.S.C. 824(a).
    (b) [Reserved]


Sec.  8.655  Can a practitioner request to temporarily treat up to 275 
patients in emergency situations?

    (a) Practitioners with a current waiver to prescribe up to 100 
patients and who are not otherwise eligible to treat up to 275 patients 
under Sec.  8.610 may request a temporary increase to treat up to 275 
patients in order to address emergency situations as defined in Sec.  
8.2 if the practitioner provides information and documentation that:
    (1) Describes the emergency situation in sufficient detail so as to 
allow a determination to be made regarding whether the situation 
qualifies as an emergency situation as defined in Sec.  8.2, and that 
provides a justification for an immediate increase in that 
practitioner's patient limit;
    (2) Identifies a period of time, not longer than 6 months, in which 
the higher patient limit should apply, and provides a rationale for the 
period of time requested; and
    (3) Describes an explicit and feasible plan to meet the public and 
individual health needs of the impacted persons once the practitioner's 
approval to treat up to 275 patients expires.
    (b) Prior to taking action on a practitioner's request under this 
section, SAMHSA shall consult, to the extent practicable, with the 
appropriate governmental authorities in order to determine whether the 
emergency situation that a practitioner describes justifies an 
immediate increase in the higher patient limit.
    (c) If SAMHSA determines that a practitioner's request under this 
section should be granted, SAMHSA will notify the practitioner that his 
or her request has been approved. The period of such approval shall not 
exceed six months.
    (d) If a practitioner wishes to receive an extension of the 
approval period granted under this section, he or she must submit a 
request to SAMHSA at least 30 days before the expiration of the six 
month period, and certify that the emergency situation as defined in 
Sec.  8.2 necessitating an increased patient limit continues. Prior to 
taking action on a practitioner's extension request under this section, 
SAMHSA shall consult, to the extent practicable, with the appropriate 
governmental authorities in order to determine whether the emergency 
situation that a practitioner describes justifies an extension of an 
increase in the higher patient limit.
    (e) Except as provided in this section and Sec.  8.650, 
requirements in other sections under subpart F of this part do not 
apply to practitioners receiving waivers in this section.

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

    Approved: June 30, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-16120 Filed 7-6-16; 8:45 am]
 BILLING CODE 4162-20-P