[Federal Register Volume 85, Number 212 (Monday, November 2, 2020)]
[Rules and Regulations]
[Pages 69153-69167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23813]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1301 and 1306

[Docket No. DEA-499]
RIN 1117-AB55


Implementation of the Substance Use-Disorder Prevention That 
Promotes Opioid Recovery and Treatment for Patients and Communities Act 
of 2018: Dispensing and Administering Controlled Substances for 
Medication-Assisted Treatment

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Interim final rule with request for comments.

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SUMMARY: The ``Substance Use-Disorder Prevention that Promotes Opioid 
Recovery and Treatment for Patients and Communities Act of 2018 (the 
SUPPORT Act),'' which became law on October 24, 2018, amended the 
Controlled Substances Act to expand the conditions a practitioner must 
meet to provide medication-assisted treatment and expand the options 
available for a physician to be considered a qualifying physician. The 
SUPPORT Act removed the time period for a nurse practitioner or 
physician assistant to be considered a qualifying other practitioner, 
and revised the definition of a qualifying practitioner. The SUPPORT 
Act also allows a pharmacy to deliver prescribed controlled substances 
to a practitioner's registered location for the purpose of maintenance 
or detoxification treatment to be administered under certain conditions 
by a practitioner. The Drug Enforcement Administration amends its 
regulations to make them consistent with the SUPPORT Act and implement 
its requirements.

DATES: This interim final rule is effective on October 30, 2020. 
Electronic comments must be submitted, and written comments must be 
postmarked, on or before January 4, 2021.

ADDRESSES: To ensure proper handling of comments, please reference 
``RIN 1117-AB55 Docket No. DEA-499'' on all correspondence, including 
any attachments.
     Electronic comments: The Drug Enforcement Administration 
encourages that all comments be submitted electronically through the 
Federal eRulemaking Portal, which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to http://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission, you will receive a 
Comment Tracking Number for your comment. Please be aware that 
submitted comments are not instantaneously available for public view on 
http://www.regulations.gov. If you have received a Comment Tracking 
Number, your comment has been successfully submitted, and there is no 
need to resubmit the same comment. Commenters should be aware that the 
electronic Federal Docket Management System will not accept comments 
after 11:59 p.m. Eastern Time on the last day of the comment period.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary and are discouraged. Should you 
wish to mail a paper comment in lieu of an electronic comment, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attn: DEA Federal Register Representative/DPW, 
Diversion Control Division; Mailing Address: 8701 Morrissette Drive, 
Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section (DPW) Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by the Drug Enforcement Administration (DEA) for public 
inspection online at http://www.regulations.gov. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter. The Freedom of 
Information Act applies to all comments received. If you want to submit 
personal identifying information (such as your name, address, etc.) as 
part of your comment, but do not want it to be made publicly available, 
you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the 
first paragraph of your comment. You must also place all of the 
personal identifying information you do not want made publicly 
available in the first paragraph of your comment and identify what 
information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this interim final rule is available at 
http://www.regulations.gov under FDMS Docket ID: DEA-499 (RIN 1117-
AB55/Docket Number DEA-499) for ease of reference.

Legal Authority

Pertinent Provisions of the SUPPORT Act

    On October 24, 2018, the President signed the SUPPORT Act into law 
as Public Law 115-271. Sections 3201 and 3202 of the SUPPORT Act 
amended certain provisions of 21 U.S.C. 823(g)(2), which is the 
subsection of the Controlled Substances Act (CSA) that sets forth the 
conditions under which a practitioner may, without being separately 
registered under subsection 823(g)(1), dispense a narcotic drug in

[[Page 69154]]

schedule III, IV, or V for the purpose of maintenance treatment \1\ or 
detoxification treatment.\2\ Section 3204 of the SUPPORT Act amended 
the CSA by adding section 309A (21 U.S.C. 829a), which sets forth the 
conditions under which a pharmacy may deliver a controlled substance to 
an administering practitioner. All of the changes to the CSA, from 
these sections of the SUPPORT Act, will be fully described below.
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    \1\ 21 U.S.C. 802(29) defines maintenance treatment as the 
dispensing, for a period in excess of twenty-one days, of a narcotic 
drug in the treatment of an individual for dependence upon heroin or 
other morphine-like drugs.
    \2\ 21 U.S.C. 802(30) defines detoxification treatment as the 
dispensing, for a period not in excess of one hundred and eighty 
days, of a narcotic drug in decreasing doses to an individual in 
order to alleviate adverse physiological or psychological effects 
incident to withdrawal from the continuous or sustained use of a 
narcotic drug and as a method of bringing the individual to a 
narcotic drug-free state within such period.
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Background

Opioid Abuse and Treatment Need

    Opioid abuse and addiction in the United States continues to impact 
disparate communities and populations. According to the report ``Key 
Substance Use and Mental Health Indicators in the United States: 
Results from the 2018 National Survey on Drug Use and Health'' released 
by the Substance Abuse and Mental Health Services Administration 
(SAMHSA), an estimated 2 million people (0.7 percent of the population) 
aged 12 or older had an opioid use disorder (OUD) in 2018.\3\ The share 
of the population estimated to have had an OUD in 2015, 2016, and 2017 
was 0.9 percent, 0.8 percent, and 0.8 percent, respectively. Among 
people aged 12 or older with an OUD in 2018, about 400,000 received 
treatment at a specialty facility in the past year, or 19.7 percent of 
all those with an OUD. The percentage of those with an OUD that 
received treatment at a specialty facility in 2015, 2016, and 2017 was 
estimated to be 21.7 percent, 21.1 percent, and 28.6 percent, 
respectively.
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    \3\ U.S. Department of Health and Human Services. SAMHSA. Key 
Substance Use and Mental Health Indicators in the United States: 
Results from the 2018 National Survey on Drug Use and Health. 2019.
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    According to the Department of Health and Human Services (HHS) 
Office of Inspector General (OIG) report titled ``Geographic 
Disparities Affect Access to Buprenorphine Services for Opioid Use 
Disorder'' published in January, 2020, 40 percent of U.S. counties have 
no ``DATA-waived'' providers,\4\ and another 24 percent have low 
patient capacity.\5\ The provisions of the SUPPORT Act being 
implemented into DEA regulation by this interim final rule directly 
address this bottleneck in available providers, and provider capacity 
by increasing the total number of providers eligible to prescribe 
buprenorphine to OUD patients.
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    \4\ On October 17, 2000, Congress passed the Drug Addiction 
Treatment Act of 2000 (DATA), amending the CSA to establish ``waiver 
authority for physicians who dispense or prescribe certain narcotic 
drugs for maintenance treatment or detoxification treatment'' (Pub. 
L. 106-310, title XXXV; 114 Stat. 1222). Prior to DATA, the CSA and 
DEA regulations required practitioners who wanted to conduct 
maintenance or detoxification treatment using narcotic controlled 
drugs to be registered as a Narcotic Treatment Program (NTP) in 
addition to the practitioner's personal registration. Hence, the 
term ``DATA-waived'' is used to describe individual practitioners 
(physicians, nurse practitioners, physician assistants, clinical 
nurse specialists, certified registered nurse anesthetists, and 
certified nurse midwives) who, having received an identification 
number from DEA, are exempt from separate registration for 
dispensing or prescribing schedule III, IV, or V narcotic controlled 
drugs approved by the Food and Drug Administration specifically for 
use in maintenance or detoxification treatment per 21 CFR 1301.28.
    \5\ Office of Inspector General, HHS, 2020. Geographic 
Disparities Affect Access To Buprenorphine Services For Opioid Use 
Disorder. U.S. Department of Health and Human Services.
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Additional Flexibility Regarding the Patient Limit for Purposes of 21 
U.S.C. 823(g)(2)

    Section 3201(a) of the SUPPORT Act amended the CSA, 21 U.S.C. 
823(g)(2)(B)(iii)(II), to provide flexibility to practitioners 
regarding the number of patients they may treat, without being 
separately registered as a narcotic treatment program, by adding more 
opportunities to increase the applicable number of patients that may be 
treated to 100. In general, the applicable number of patients that may 
be treated at one time is 30. Prior to the SUPPORT Act, the CSA set the 
applicable number of patients a practitioner may treat at 100 only when 
a practitioner submitted a second notification to the Secretary of HHS 
for the need and intent of the practitioner to treat up to 100 
patients, no sooner than one year after the date on which the initial 
notification was submitted.
    After promulgation of the SUPPORT Act, a practitioner may treat up 
to 100 patients under two additional circumstances: (1) If the 
practitioner holds additional credentialing,\6\ or (2) if a 
practitioner provides medication-assisted treatment \7\ using covered 
medications \8\ in a qualified practice setting.\9\
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    \6\ ``Additional credentialing'' is defined as ``board 
certification in addiction medicine or addiction psychiatry by the 
American Board of Addiction Medicine, the American Board of Medical 
Specialties, or the American Osteopathic Association or 
certification by the American Board of Addiction Medicine, or the 
American Society of Addiction Medicine.'' 42 CFR 8.2.
    \7\ 42 CFR 8.2 defines medication-assisted treatment as 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.
    \8\ ``Covered medications'' are ``the drugs or combinations of 
drugs that are covered under 21 U.S.C. 823(g)(2)(C).'' 42 CFR 8.2.
    \9\ A ``qualified practice setting'' is described in 42 CFR 
8.615.
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    Section 3201(a) also allows a practitioner to treat more patients, 
increasing the applicable number to 275 patients if a practitioner 
meets the requirements set forth in 42 CFR 8.610-8.655. DEA added this 
additional applicable number to its regulations in a January 2018 final 
rule,\10\ to reflect new limits set by HHS in a July 2016 final 
rule.\11\ Under this rule, DEA is updating the regulations to reflect 
the new description in section 3201(a).
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    \10\ 83 FR 3071, January 23, 2018.
    \11\ 81 FR 44712, July 8, 2016.
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    DEA is implementing these changes to the CSA by revising DEA 
regulations in 21 CFR 1301.28(b)(1)(iii)(B)-(C).

Elimination of Time Limit for Certain Qualifying Practitioners and 
Expanding the Definition of Qualifying Other Practitioner

    The CSA mandates that a practitioner who dispenses narcotic drugs 
for maintenance treatment or detoxification treatment must be a 
qualifying practitioner. 21 U.S.C. 823(g)(2)(B)(i). Prior to the 
SUPPORT Act, the CSA defined a qualifying practitioner, under 21 U.S.C. 
823(g)(2)(G)(iii), as a qualifying physician \12\ and also temporarily 
(until October 1, 2021) as a ``qualifying other practitioner,'' which 
included a nurse practitioner or physician assistant who meets certain 
qualifications set forth in 21 U.S.C. 823(g)(2)(G)(iv). Sections 
3201(b) through (d) of the SUPPORT Act updated the CSA to by 
permanently allowing a nurse practitioner or a physician assistant to 
be considered a ``qualifying other practitioner,'' and temporarily 
(until October 1, 2023) expanding the definition of a ``qualifying 
practitioner'' to also include a clinical nurse specialist, certified 
registered nurse anesthetist, or a certified nurse midwife who meets 
certain qualifications set forth in 21 U.S.C. 823(g)(2)(G)(iv), 
allowing more flexibility. Those qualifications for clinical nurse 
specialists, certified registered nurses, or certified nurse midwives, 
pertaining to training, experience, and supervision, are the

[[Page 69155]]

same as those that previously only applied to nurse practitioners or 
physician assistants.
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    \12\ The CSA defines a ``qualifying physician'' as a physician 
who is licensed under State law and who meets one or more of certain 
listed conditions. 21 U.S.C. 823(g)(2)(G)(ii).
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    DEA is implementing these changes to the CSA by revising DEA 
regulations in 21 CFR 1301.28(b)(1)(i).

New Option To Allow a Physician To Become a Qualifying Physician

    Section 3202(a) of the SUPPORT Act amended 21 U.S.C. 
823(g)(2)(G)(ii) by adding a new option for a physician to be 
considered a ``qualifying physician.'' Prior to the SUPPORT Act, a 
physician could become a qualifying physician through seven different 
options. The additional option allows a physician to be considered a 
qualifying physician if they graduated in good standing from an 
accredited school of allopathic medicine or osteopathic medicine in the 
United States within the five-year period immediately preceding the 
date that the physician submitted a written notification to the 
Secretary of HHS of their intent to dispense narcotic drugs for 
maintenance or detoxification treatment, and successfully completed a 
comprehensive allopathic or osteopathic medicine curriculum or 
accredited medical residency. This curriculum or residency must have 
included at least eight hours of training on treating and managing 
opioid-dependent patients, and, at a minimum, included training 
described in 21 U.S.C. 823(g)(2)(G)(IV)(aa)-(gg), and any other 
training the Secretary of HHS determines should be included in the 
curriculum, including training on pain management, and the assessment 
and appropriate use of opioid and non-opioid alternatives. The SUPPORT 
Act added this training requirement to the CSA at 21 U.S.C. 
823(g)(G)(ii)(VIII), however, there is no corresponding regulation in 
the Code of Federal Regulations that DEA needs to revise and update 
because the definition of ``qualifying physician'' is only referred to 
in the regulations. See 21 CFR 1301.28 (b)(1)(i).

Dispensing Controlled Substances for Maintenance or Detoxification 
Treatment

    Section 3204(a) of the SUPPORT Act amended the CSA by adding 
section 309A (21 U.S.C. 829a), which sets forth the conditions in which 
a pharmacy may deliver a controlled substance to an administering 
practitioner. Specifically, the new section 829a allows a pharmacy to 
deliver, notwithstanding the definition of dispense (21 U.S.C. 
802(10)),\13\ a prescribed controlled substance (that meets the 
requirements issued by the Attorney General under title 21 of the 
U.S.C.) to the prescribing practitioner's or administering 
practitioner's registered location for the purpose of maintenance or 
detoxification treatment to be administered to a patient under specific 
conditions. Prior to this new section 829a, pharmacies were only 
allowed to deliver controlled substances to the ultimate user or 
research subject.
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    \13\ The term dispense means to deliver a controlled substance 
to an ultimate user or research subject by, or pursuant to the 
lawful order of, a practitioner including the prescribing and 
administering of a controlled substance and the packaging, labeling, 
or compounding necessary to prepare the substance for such delivery 
21 U.S.C. 802(10).
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    Under section 829a, a pharmacy is allowed to dispense prescribed 
narcotic drugs in schedule III, IV, or V, or combinations of such 
drugs, to a practitioner for the purpose of maintenance or 
detoxification treatment under 21 U.S.C. 823(g)(2) and certain 
conditions. Specifically, the prescription must be issued by a 
qualifying practitioner and the prescription issued cannot be used to 
supply any practitioner with a stock of controlled substances for the 
purpose of general dispensing to patients. In addition, the 
practitioner must meet the following conditions:
    1. The practitioner must administer the controlled substance to the 
patient named on the prescription:
    a. By implantation or injection;
    b. within 14 days after the date of receipt of the controlled 
substance by the practitioner.
    2. The practitioner and pharmacy are authorized to conduct these 
activities in the State in which such activities take place.
    3. The prescribing practitioner and administering practitioner of 
the controlled substance maintain complete and accurate records of all 
controlled substances delivered, received, administered, and disposed 
including the persons to whom controlled substances were delivered and 
such other information that the Attorney General may require by 
regulations.

Regulatory Analysis

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (APA) (5 U.S.C. 553), 
including those requiring the publication of a prior notice of proposed 
rulemaking and the pre-promulgation opportunity for public comment, if 
such actions are determined to be unnecessary, impracticable, or 
contrary to the public interest.
    DEA finds there is good cause within the meaning of the APA to 
issue these amendments as an interim final rule and to delay comment 
procedures to the post-publication period, because these amendments 
merely conform the implementing regulations with recent amendments to 
the CSA that have already taken effect. DEA has no discretion with 
respect to these amendments. This rule merely incorporates the 
statutory amendments into DEA's regulations, and publishing a notice of 
proposed rulemaking or soliciting public comment prior to publication 
is unnecessary. See 5 U.S.C. 553(b)(B) (relating to notice and comment 
procedures). ``[W]hen regulations merely restate the statute they 
implement, notice-and-comment procedures are unnecessary.'' Gray 
Panthers Advocacy Committee v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 
1991); see also United States v. Cain, 583 F.3d 408, 420 (6th Cir. 
2009) (contrasting legislative rules, which require notice-and-comment 
procedures, ``with regulations that merely restate or interpret 
statutory obligations,'' which do not); Komjathy v. Nat. Trans. Safety 
Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (when a rule ``does no more 
than repeat, virtually verbatim, the statutory grant of authority'' 
notice-and-comment procedures are not required).
    In addition, because the statutory changes at issue have already 
been in effect since October 24, 2018, DEA finds good cause exists to 
make this rule effective immediately upon publication. See 5 U.S.C. 
553(d). Therefore, DEA is issuing these amendments as an interim final 
rule, effective October 30, 2020. DEA is publishing this rule as an 
interim final rule and is establishing a docket to receive public 
comment on this rule. To the extent required by law, DEA will consider 
and respond to any relevant comments received.
    As explained above, DEA is obligated to issue this interim final 
rule to revise its regulations so that they are consistent with the 
provisions of the CSA that were amended by the SUPPORT Act. In issuing 
this interim final rule, DEA has not gone beyond the statutory text 
enacted by Congress. Thus, DEA would have to issue this interim final 
rule regardless of the outcome of the agency's regulatory analysis. 
Nonetheless, DEA conducted this analysis as discussed below.

[[Page 69156]]

Executive Orders 12866 (Regulatory Planning and Review), 13563 
(Improving Regulation and Regulatory Review), and 13771 (Reducing 
Regulation and Controlling Regulatory Costs)

    This interim final rule was developed in accordance with the 
principles of Executive Orders (E.O.) 12866 and 13563. E.O. 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). E.O. 13563 is supplemental to and 
reaffirms the principles, structures, and definitions governing 
regulatory review as established in E.O. 12866. E.O. 12866 classifies a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), as any regulatory action that is likely to 
result in a rule that may: (1) Have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; (2) create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the E.O.
    The economic, interagency, budgetary, legal, and policy 
implications of this interim final rule have been examined and it has 
been determined to be an economically significant regulatory action 
under E.O. 12866 with a net annualized benefit of $543 million over 
five years, and therefore, has been submitted to OMB for review.
    E.O. 13771, titled ``Reducing Regulation and Controlling Regulatory 
Costs,'' was issued on January 30, 2017, and published in the Federal 
Register on February 3, 2017. 82 FR 9339. Section 2(a) of E.O. 13771 
requires an agency, unless prohibited by law, to identify at least two 
existing regulations to be repealed when the agency publicly proposes 
for notice and comment or otherwise promulgates a new regulation. In 
furtherance of this requirement, section 2(c) of E.O. 13771 requires 
that the new incremental costs associated with new regulations, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations. Guidance from OMB, 
issued on April 5, 2017, explains that the above requirements only 
apply to each new ``significant regulatory action that . . . imposes 
costs.''
    DEA estimates that this interim final rule will expand the number 
of DATA-waived treatment providers, qualifying it as an ``enabling 
rule'' according to E.O. 13771 guidance from OMB issued on April 5, 
2017. Therefore, DEA expects that this interim final rule will be 
classified as an E.O. 13771 deregulatory action by OMB.

A. Need for the Rule

    On October 24, 2018, the SUPPORT Act became law. With this interim 
final rule, DEA is amending its regulations governing providers of 
medication-assisted treatment (MAT) to incorporate statutory changes 
made to the CSA by the SUPPORT Act.

B. Alternative Approaches

    This interim final rule amends DEA regulations only to the extent 
necessary to be consistent with current Federal law as modified by the 
SUPPORT Act. Because DEA is obligated to implement these provisions of 
the SUPPORT Act, DEA has no discretion not to amend its regulations as 
is being done in this interim final rule. Indeed, the new provisions 
issued under this interim final rule are already in effect by virtue of 
the SUPPORT Act, and this interim final rule simply updates DEA 
regulations to reflect these new provisions; thus, no alternative 
approaches are possible.

C. Analysis of Benefits and Costs

    This analysis is limited to the provisions of the interim final 
rule implementing into regulation the following statutory changes of 
the SUPPORT Act: Revising the definition of a qualifying practitioner, 
permanently allowing a nurse practitioner (NP) or physician assistant 
(PA) to be considered a qualifying other practitioner, expanding the 
options available for a physician to be considered a qualifying 
physician, and allowing a pharmacy to deliver prescribed controlled 
substances to a practitioner's registered location for the purpose of 
maintenance or detoxification treatment.
    Benefits of the interim final rule, in the form of economic burden 
reductions and other cost savings (health care costs, criminal justice 
costs, and lost productivity costs), are expected from permanently 
allowing NPs or PAs to dispense narcotic drugs for maintenance and 
detoxification treatment, and from granting qualified clinical nurse 
specialists (CNS), certified registered nurse anesthetists (CRNA), and 
certified nurse midwives (CNM) the same dispensing privileges as NPs 
and PAs for a five year period ending on October 1, 2023. These 
benefits are significant and are quantified in the following analysis 
and discussion. DEA anticipates the expansion of the categories of 
practitioners will lead to an increase in the number of treatment 
providers, and to an increase in the number of patients (who did not 
have access to treatment prior to this rule) treated, resulting in a 
reduction in the economic burden of opioid abuse. DEA also expects 
benefits by allowing maintenance or detoxification treatment providers 
to treat up to 100 patients, expanding the options available for a 
physician to be considered a qualifying physician, and allowing a 
pharmacy to deliver prescribed controlled substances to a 
practitioner's registered location for the purpose of maintenance or 
detoxification treatment. These benefits will be discussed 
qualitatively in the following analysis.
    Costs of the interim final rule are associated with the treatment 
cost of opioid addicted patients and the cost to practitioners of 
obtaining authority to dispense a narcotic drug in schedule III, IV, or 
V for the purpose of maintenance or detoxification treatment. The costs 
of obtaining dispensing authority and treating patients are required to 
generate the benefits of the rule, and thus, are included in this 
analysis. Although the new treatment providers in the expanded category 
and qualifying other practitioners will also need to comply with 
treatment-specific recordkeeping requirements, the cost of compliance 
is included in the estimated cost of treatment as explained in the 
section ``Other Potential Costs.'' DEA also estimates that there will 
be a cost savings resulting from patients being able to access 
buprenorphine treatment through treatment providers that are not 
physicians. Finally, there is potential for added risk of diversion 
from more practitioners having the authority to dispense narcotic drugs 
in schedule III, IV, or V for the purpose of maintenance or 
detoxification treatment. This risk is discussed in the section ``Risk 
of Diversion.''
Increase in the Number of Data-Waived Providers Eligible To Treat 100 
Patients
    Section 3201(a) of the SUPPORT Act amended the CSA, specifically 21 
U.S.C. 823(g)(2)(B)(iii)(II), to allow for additional circumstances in 
which

[[Page 69157]]

DATA-waived providers may treat up to 100 patients for maintenance and 
detoxification treatment, instead of the default 30 patient limit. 
Prior to the SUPPORT Act, providers were required to wait one year 
before notifying SAMHSA of their desire to increase their DATA-waived 
patient limit to 100. Now, DATA-waived practitioners may immediately 
treat up to 100 patients if the practitioner holds additional 
credentialing in addiction medicine, or provides MAT using covered 
medications, in a qualified practice setting. This provision only 
affected qualifying practitioners that became immediately eligible in 
the first year after the SUPPORT Act became law, and the following 
analysis is limited to this group of practitioners.
    DEA assumes that there are some qualifying practitioners that, 
within the first year of obtaining a DATA-waiver, quickly reach the 30 
patient limit. These high-capacity MAT providers were most likely to 
benefit from the additional flexibility provided by the SUPPORT Act by 
beginning to treat up to 100 patients immediately rather than waiting a 
full year. DEA does not have a good basis to estimate the number of 
qualifying practitioners who took advantage of this flexibility within 
the first year of the SUPPORT Act becoming law; however, it is believed 
to be minimal for two reasons. First, in general, DEA believes it is 
unlikely that many practitioners develop a capacity to treat more than 
30 MAT patients within their first 12 months of obtaining a DATA-
waiver. There are many factors that influence how many patients a DATA-
waived practitioner's treats, including, but not limited to patient 
demand for treatment; insufficient time, staff, and office space; \14\ 
Medicaid and insurance reimbursement rates; \15\ and a regulatory 
environment perceived to be overly burdensome.\16\ The vast majority of 
newly-DATA-waived providers are likely to be conservative in the first 
year of delivering MAT as they consider these factors and navigate a 
changing regulatory environment, whether they have advanced training in 
addiction medicine or not.
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    \14\ Andrilla CHA, Coulthard C, and Larson EH. ``Barriers Rural 
Physicians Face Prescribing Buprenorphine for Opioid Use Disorder.'' 
The Annals of Family Medicine 15, no. 4 (2017): 359-62. https://doi.org/10.1370/afm.2099.
    \15\ Stein BD, Gordon AJ, Dick AW, Burns RM, Pacula RL, Farmer 
CM, Leslie DL, and Sorbero M. ``Supply of Buprenorphine Waivered 
Physicians: The Influence of State Policies.'' Journal of Substance 
Abuse Treatment 48, no. 1 (2015): 104-11. https://doi.org/10.1016/j.jsat.2014.07.010.
    \16\ Haffajee RL, Bohnert ASB, and Lagisetty PA. ``Policy 
Pathways to Address Provider Workforce Barriers to Buprenorphine 
Treatment.'' American Journal of Preventive Medicine 54, no. 6 
(2018). https://doi.org/10.1016/j.amepre.2017.12.022.
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    Second, for qualifying practitioners that do take on up to 30 
patients in their first year of practicing, it is not likely that they 
are able to build their patient base to an amount greater than 30 
before they would have previously been eligible to apply for the 100-
patient DATA-waiver. DEA assumes that the growth in patients under 
treatment for any qualifying practitioner advances quickly in the 
beginning, but slows and eventually levels off as their practice 
matures. A recent academic study supports this, finding that 
practitioners possessing DATA-waivers to treat up to 100 patients 
(therefore having been DATA-waived for at least one full year) do not 
approach this limit, and instead have an average monthly patient census 
of 42.9.\17\ Thus, DEA believes it is reasonable to assume that if a 
high-capacity practitioner reached the 30 patient limit within the 
first year of the SUPPORT Act becoming law, it is not likely that 
practitioner was able to expand their number of patients under 
treatment to more than 30 before they would have been previously 
eligible for a 100-patient waiver prior to this provision of the 
SUPPORT Act.
---------------------------------------------------------------------------

    \17\ Thomas CP, Doyle E, Kreiner PW, Jones CM, Dubenitz J, Horan 
A, and Stein BD. ``Prescribing Patterns of Buprenorphine Waivered 
Physicians.'' Drug and Alcohol Dependence 181 (2017): 213-18. 
https://doi.org/10.1016/j.drugalcdep.2017.10.002.
---------------------------------------------------------------------------

    Since DEA does not have a good basis for estimating the number of 
practitioners that qualified, nor how many more patients these high-
capacity practitioners treated in their first year of becoming DATA-
waived after the SUPPORT Act became law, DEA is unable to quantify the 
benefit of this enabling provision.
Permanently Allowing Nurse Practitioners and Physician Assistants To 
Practice as ``Qualifying Practitioners''
    The SUPPORT Act makes permanent the five-year temporary exception 
for NPs and PAs to become DATA-waived and practice as ``Qualifying 
Practitioners,'' originally authorized by the Comprehensive Addiction 
and Recovery Act (CARA) of 2016. The temporary authorization was 
incorporated into DEA regulations through promulgation of a 2018 final 
rule.\18\ DEA's analysis of the benefits and costs of this 2018 final 
rule concluded that all qualified NPs and PAs that would become DATA-
waived would do so in the first two years of eligibility (July 22, 2016 
to September 30, 2018),\19\ as the temporary nature of the exception 
and uncertainty of the long-term status of this group's eligibility 
would disincentivize their investment in becoming DATA-waived in years 
three through five. This temporary exception for NPs and PAs was made 
permanent by the SUPPORT Act at the beginning of their third year of 
eligibility, thus incentivizing this group's long-term investment in 
obtaining DATA-waivers.
---------------------------------------------------------------------------

    \18\ 83 FR 3071 (January 23, 2018).
    \19\ DEA's analysis of the benefits and costs of this 2018 final 
rule used the following date ranges to correspond with years one 
through five of temporary DATA-waived eligibility for NPs and PAs: 
Year one corresponds to 7/22/2016-9/30/2017; year two corresponds to 
10/1/2017-9/30/2018; year three to 10/1/2018-9/30/2019; year four to 
10/1/2019-9/30/2020; and year five to 10/1/2020-9/30/2021. The 
SUPPORT Act was signed into law on October 24, 2018, shortly after 
the beginning of year three.
---------------------------------------------------------------------------

    Absent the permanent eligibility granted to NPs and PAs by the 
SUPPORT Act, the DATA-waivers of all ``Qualifying Practitioners'' would 
expire on October 1, 2021, roughly three years after the SUPPORT Act 
became law, and the end of year three of this analysis. For the 
purposes of this analysis, year one corresponds to October 25, 2018, 
through August 15, 2019; year two corresponds to August 16, 2019, 
through October 31, 2020; year three to November 1, 2020, through 
October 31, 2021; year four to November 1, 2021, through October 31, 
2022; and year five to November 1, 2022, through October 1, 2023.\20\ 
According to DEA registration data, as of April, 2020, mid-way through 
year two, there are 18,373 DATA-waived NPs and PAs.\21\ Because DEA 
does not have a good basis to forecast how many more NPs and PAs might 
become DATA-waived through the conclusion of year five of this 
analysis, DEA conservatively assumes that the number of DATA-waived NPs 
and PAs will remain constant at the current level of 18,373 through 
October 1, 2023.
---------------------------------------------------------------------------

    \20\ DEA chose to limit the analysis period of this interim 
final rule to five years due to the evolving nature of the opioid 
epidemic and the long-term uncertainty of the laws and rules being 
implemented to combat it.
    \21\ DEA's internal registration database currently does not 
distinguish between DATA-waived CNS, CRNAs, or CNMs and DATA-waived 
NPs and PAs. In order to avoid double counting, DEA must adjust the 
number of DATA-waived mid-level NPs and PAs as of April, 2020 
(19,409) downward by the estimated increase in DATA-waived CNS/CRNA/
CNMs to date. As detailed in the following section, DEA estimates 
that 691 CNS/CRNA/CNMs become DATA-waived in each of the first two 
years of this analysis. Because, at the time of this writing, year 
two is roughly 50 percent complete, DEA estimates that 1,037 (691 + 
(691/2) = 1,037) CNS/CRNA/CNMs have obtained a DATA-waiver thus far. 
Subtracting 1,037 from 19,409 results in an estimated 18,373 NPs and 
PAs that are currently DATA-waived.

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

[[Page 69158]]

    Because even in the absence of the SUPPORT Act, NPs and PAs would 
be eligible for a DATA-waiver due to the temporary authorization 
provided by CARA through September 30, 2021, only the estimated number 
of DATA-waived NPs and PAs in year four and year five are relevant to 
this analysis. The following table illustrates how each year of this 
analysis corresponds to the DATA-waiver eligibility for NPs and PAs 
provided by CARA and the SUPPORT Act, respectively.

----------------------------------------------------------------------------------------------------------------
                                    DATA-waiver eligibility provided by CARA          DATA-waiver eligibility
                                -------------------------------------------------     provided by SUPPORT Act
                                                                                 -------------------------------
                                     Year 1          Year 2           Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Total Number of DATA-waived NPs  ..............  ..............  ...............          18,373          18,373
 and PAs.......................
----------------------------------------------------------------------------------------------------------------

    Therefore, DEA estimates that 18,373 NPs and PAs would lose their 
DATA-waiver eligibility and their ability to provide MAT to patients in 
year four and year five of this analysis if not for the SUPPORT Act.
Expanding the Definition of ``Qualifying Other Practitioner''
    This interim final rule also implements the SUPPORT Act provision 
that allows CNS, CRNAs, or CNMs to apply for DATA-waived status and 
practice as ``Qualifying Other Practitioners'' for a temporary period 
ending October 1, 2023. The DATA-waived eligibility of CNS/CRNA/CNMs is 
new, and as a result, DEA does not have a strong basis to estimate the 
number of CNS/CRNA/CNMs that would request DATA-waived status. Because 
DEA's internal registration database currently does not distinguish 
between DATA-waived CNS/CRNA/CNMs and DATA-waived NPs and PAs, it is 
likely that any CNS/CRNA/CNMs that have become DATA-waived since the 
SUPPORT Act became law are currently being categorized as ``Mid-Level 
Practitioner--DATA-waived Nurse Practitioner'' (MLP-DW NP) or ``Mid-
Level Practitioner--DATA-waived Physician Assistant'' (MLP-DW PA). 
Because of this, it is not possible to determine how many CNS/CRNA/CNMs 
have already obtained DATA-waived status in their first year of 
eligibility. However, DEA believes this number to be low since CNS/
CRNA/CNM eligibility is new, and many businesses and individuals are 
still weighing the personal benefits and costs of becoming or employing 
a DATA-waived CNS/CRNA/CNM.
    For the purposes of this analysis, DEA conservatively assumes the 
ratio of DATA-waived CNS/CRNA/CNMs to all CNS/CRNA/CNMs authorized to 
prescribe controlled substances will be equal to the ratio of DATA-
waived NPs and PAs to all DEA registered NPs and PAs. Based on DEA 
records, as of August 15, 2019, the end of year one of this analysis, 
four percent of DEA-registered NPs and PAs are DATA-waived. DEA 
estimates that 69,128 \22\ CNS/CRNA/CNMs are eligible to prescribe 
controlled substances in the United States. Four percent of 69,128 is 
2,765. Therefore, DEA estimates that 2,765 CNS/CRNA/CNMs will become 
DATA-waived during the temporary eligibility period.
---------------------------------------------------------------------------

    \22\ Bureau of Labor Statistics (BLS) state-level employment 
data of 41,800 CRNAs and 6,500 CNMs (https://www.bls.gov/ooh/healthcare/nurse-anesthetists-nurse-midwives-and-nurse-practitioners.htm#tab-6) were used to calculate the total U.S. 
employment for this group. However, BLS does not differentiate 
between all Registered Nurses (RNs) and the more specialized CNS, 
which are considered Advanced Practice Registered Nurses (APRN) 
because of their education, training, and duties, because there is 
no separate Standard Occupational Classification (SOC) code for CNS. 
Therefore, DEA chose to use a U.S. employment estimate of 72,000 CNS 
provided by the National Association of Clinical Nurse Specialists 
(https://explorehealthcareers.org/career/nursing/clinical-nurse-specialist/) and assumed that the percentage of CNS employment 
distributed per state matches the distribution of RN employment by 
state. DEA then excluded employment data from states that do not 
allow CNS/CRNA/CNMs to prescribe controlled substances, resulting in 
40,298 CNS with prescribing authority, 23,920 CRNAs with prescribing 
authority and 4,910 CNMs with prescribing authority. This results in 
a total of 69,128 CNS/CRNA/CNMs with prescribing authority in the 
U.S.
---------------------------------------------------------------------------

    DEA also assumes that all DATA-waived CNS/CRNA/CNMs will be 
certified in year one through four \23\ as the burden of obtaining 
DATA-waived status outweighs the incentives as the expiration of the 
temporary provision nears. Smoothing the estimated 2,765 DATA-waived 
CNS/CRNA/CNMs over four years results in an estimated yearly increase 
of 691 (rounded). Thus, DEA estimates 691 CNS/CRNA/CNMs have become 
DATA-waived in year one of this analysis which will increase to 1,382 
in year two, and this calculation progresses linearly until a grand 
total of 2,765 is reached in year four, and remains steady for year 
five. The table below summarizes this calculation.
---------------------------------------------------------------------------

    \23\ DEA considered an estimate of the growth of CNS/CRNA/CNMs 
that ceased at the end of year two, however, it is likely that CNS/
CRNA/CNMs will expect this temporary exception to become permanent 
just as the exception for NPs and PAs has, encouraging growth of 
this category until year four.

----------------------------------------------------------------------------------------------------------------
                                      Year 1          Year 2          Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Group 1: CNS/CRNA/CNMs obtaining             691             691             691             691             691
 DATA-waived status in year 1...
Group 2: CNS/CRNA/CNMs obtaining  ..............             691             691             691             691
 DATA-waived status in year 2...
Group 3: CNS/CRNA/CNMs obtaining  ..............  ..............             691             691             691
 DATA-waived status in year 3...
Group 4: CNS/CRNA/CNMs obtaining  ..............  ..............  ..............             691             691
 DATA-waived status in year 4...
                                 -------------------------------------------------------------------------------
    Total Number of DATA-waived              691           1,382           2,073           2,765           2,765
     CNS/CRNA/CNMs..............
----------------------------------------------------------------------------------------------------------------


[[Page 69159]]

New Option for a Physician To Become a Qualifying Physician
    This enabling provision of the interim final rule provides another 
option for a physician to become qualified to apply for a DATA waiver. 
While DEA does not have a good basis to quantify the impact of this 
change, this provision is expected to increase the number of new 
qualifying physicians, and thus, increase the number of full-time 
equivalent (FTE) patients \24\ treated.
---------------------------------------------------------------------------

    \24\ ``Full-time-equivalent'' patient is a notional value 
equivalent to a patient under treatment for the full year. For 
example, if two patients were under treatment for 6 months, they 
would total 1 full-time-equivalent patient. The equivalent full-time 
patient concept has been previously used by DEA and the Substance 
Abuse and Mental Health Services Administration (SAMHSA) in its 
estimate of patient increases. Implementation of the Provision of 
the Comprehensive Addiction and Recovery Act of 2016 Relating to the 
Dispensing of Narcotic Drugs for Opioid Use Disorder, 83 FR 3071 
(January 23, 2018), and Medication Assisted Treatment for Opioid Use 
Disorders, 81 FR 66191 (July 8, 2016).
---------------------------------------------------------------------------

    This new option essentially shifts the eight-hour training 
requirement for a physician to become DATA-waived from post-residency 
Continuing Medical Education (CME) to medical school or residency for 
physicians that complete a medical school curriculum or residency that 
includes at least eight hours of training on treating and managing 
opioid-dependent patients. While this option streamlines the training 
for physicians that complete medical school or residency featuring 
curriculum that meets the training standard; it does not eliminate the 
eight-hour training requirement. DEA does not have a good basis to 
estimate the number of medical school curriculums that currently meet 
this eight-hour training requirement but assumes it to be low, but 
likely to increase in the future. Therefore, DEA is unable to quantify 
the expected cost savings of this provision.
Allowing Pharmacies To Deliver Controlled Substances to a 
Practitioner's Registered Location
    Prior to this enabling provision of the SUPPORT Act, pharmacies 
were only allowed to deliver controlled substances to the ultimate user 
or research subject. However, for patients prescribed extended-release 
injectable or implantable MAT drugs, DEA provided an exception to this 
restriction and allowed the delivery of medication directly from the 
pharmacy to the practitioner in order for the patient to have their 
monthly (injectable) or semi-annual (implantable) dosage administered 
directly in the providers' office without first requiring a trip to the 
pharmacy. The SUPPORT Act has now made this exception permanent by 
allowing pharmacies to deliver prescribed narcotic drugs in schedule 
III, IV, or V, or combinations of such drugs, to a practitioner for the 
purpose of maintenance and detoxification to be administered by a 
practitioner through injection or implantation to patients.
    Because this provision of the interim final rule is simply 
codifying previous DEA practice and the current law, DEA expects this 
provision of the interim final rule to result in no costs or benefits.
Increase in the Number of Patients Receiving Treatment
    As discussed above, the expansion of DATA-waived providers to 
include CNS/CRNA/CNMs on a temporary basis, and NPs and PAs on a 
permanent basis, is expected to result in more opioid-addicted patients 
treated. Any increase in the number of patients receiving treatment as 
a result of this interim final rule will depend not only on an increase 
in the number of providers offering services, but also on the number of 
patients currently unable to obtain treatment due to a lack of 
providers. There is a well-documented treatment gap in the United 
States between prescription opioid abusers or people dependent on 
opioids and MAT providers.25 26 Therefore, DEA assumes that 
there is sufficient demand for treatment services that will be met with 
the expanded patient capacity created by the SUPPORT Act.
---------------------------------------------------------------------------

    \25\ Jones et al., ``National and State Treatment Need and 
Capacity for Opioid Agonist Medication-Assisted Treatment'' American 
Journal of Public Health 105, no. 8 (2015):e55-63.
    \26\ Office of Inspector General, HHS, 2020. Geographic 
Disparities Affect Access To Buprenorphine Services For Opioid Use 
Disorder. U.S. Department of Health and Human Services.
---------------------------------------------------------------------------

    The number of FTE patients treated by each newly DATA-waived CNS/
CRNA/CNM is expected to be low in the first year and steadily increase 
as their practices mature. While the patient limit for DATA-waived CNS/
CRNA/CNM is set at 30 patients,\27\ the actual number of patients 
treated on a FTE basis is expected to be lower for a variety of 
reasons, including delays in patient referrals; patients discontinuing 
treatment without notifying the practitioner; the difference in 
duration of treatments among patients and inability to perfectly time 
the replacing of one patient for another while at the patient limit; 
demands on CNS/CRNA/CNMs to treat patients for conditions other than 
maintenance and detoxification; private insurance and Medicaid coverage 
limitations; \28\ travel difficulties for patients located in rural 
areas; \29\ and etc.
---------------------------------------------------------------------------

    \27\ The ``patient limit'' is the ``total number of such 
patients of the practitioner at any one time . . .'' 21 U.S.C. 
823(g)(2)(B)(iii)(I). The Secretary of HHS may by regulation change 
the patient limit, but for the purposes of this analysis, DEA 
conservatively assumes that the patient limit of 30 will apply for 
CNS/CRNA/CNMs over the analysis period.
    \28\ Rinaldo SG and Rinaldo DW. Availability Without 
Accessibility? State Medicaid Coverage and Authorization 
Requirements for Opioid Dependence Medications. 2013. http://www.asam.org/docs/default-source/advocacy/aaam_implications-for-opioid-addiction-treatment_final.
    \29\ Sigmon SC. Access to treatment for opioid dependence in 
rural America: Challenges and future directions. JAMA Psychiatry. 
2014;71(4): 359-360. https://doi.org/10.1001/jamapsychiatry.2013.4450.
---------------------------------------------------------------------------

    A recent study regarding the prescribing patterns of MAT providers 
found that practitioners with 30-patient DATA-waivers treated an 
average of 13.6 patients per month.\30\ For the purposes of this 
analysis, and consistent with this research, DEA assumes CNS/CRNA/CNMs 
will slowly build to treating 13.5 average FTE patients over five 
years. Therefore, this analysis assumes each DATA-waived CNS/CRNA/CNM, 
upon becoming DATA-waived, will treat 7.5, 9, 10.5, 12, and 13.5 FTE 
patients in years 1, 2, 3, 4, and 5, respectively.
---------------------------------------------------------------------------

    \30\ Thomas, et al., ``''Prescribing Patterns of Buprenorphine 
Waivered Physicians'','' Drug and Alcohol Dependence, 181, 
Supplement C (2017): 213-218.
---------------------------------------------------------------------------

    Applying the assumed average FTE patients for each group of DATA-
waived CNS/CRNA/CNM in the year they obtained DATA-waived status, DEA 
estimated the number of FTE patients expected to be treated for each 
year. The average FTE patients treated of 7.5, 9, 10.5, 12, and 13.5 in 
years 1, 2, 3, 4, and 5, respectively, were applied to Group 1 (the 
group of 691 CNS/CRNA/CNMs that obtained DATA-waived status in year 
one) to estimate the number of patients treated by this group in each 
of the five years. The average FTE patients treated of 7.5, 9, 10.5, 
and 12, in years 2, 3, 4, and 5 were applied to Group 2 (the group of 
691 CNS/CRNA/CNMs that obtain DATA-waived status in year two) to 
estimate the number of patients treated by this group in each of the 
four remaining years. Similar calculations were performed for Groups 3 
(the group of 691 CNS/CRNA/CNMs that obtain DATA-waived status in year 
three) and 4.\31\ Adding the number of FTE patients treated by the four 
groups, DEA estimates a total of 5,183; 11,402;

[[Page 69160]]

18,657; 26,949; and 31,095 FTE patients are treated in years 1, 2, 3, 
4, and 5, respectively. The table below summarizes this analysis.
---------------------------------------------------------------------------

    \31\ DEA assumes that all DATA-waived CNS/CRNA/CNMs will be 
certified in years one through four as the burden of obtaining DATA-
waived status outweighs the incentives as the expiration of the 
temporary provision nears. Therefore, there is no ``Group 5''.

----------------------------------------------------------------------------------------------------------------
                                      Year 1          Year 2          Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Group 1: CNS/CRNA/CNMs obtaining             691             691             691             691             691
 DATA-waived status in year 1...
Average full-time-equivalent                 7.5               9            10.5              12            13.5
 patients treated per CNS/CRNA/
 CNMs per year for Group 1......
                                 -------------------------------------------------------------------------------
    Patients treated by Group 1.           5,183           6,219           7,256           8,292           9,329
----------------------------------------------------------------------------------------------------------------
Group 2: CNS/CRNA/CNMs obtaining  ..............             691             691             691             691
 DATA-waived status in year 2...
Average full-time-equivalent      ..............             7.5               9            10.5              12
 patients treated per CNS/CRNA/
 CNMs per year for Group 2......
                                 -------------------------------------------------------------------------------
    Patients treated by Group 2.  ..............           5,183           6,219           7,256           8,292
----------------------------------------------------------------------------------------------------------------
Group 3: CNS/CRNA/CNMs obtaining  ..............  ..............             691             691             691
 DATA-waived status in year 3...
Average full-time-equivalent      ..............  ..............             7.5               9            10.5
 patients treated per CNS/CRNA/
 CNMs per year for Group 3......
                                 -------------------------------------------------------------------------------
    Patients treated by Group 3.  ..............  ..............           5,183           6,219           7,256
----------------------------------------------------------------------------------------------------------------
Group 4: CNS/CRNA/CNMs obtaining  ..............  ..............  ..............             691             691
 DATA-waived status in year 4...
Average full-time-equivalent      ..............  ..............  ..............             7.5               9
 patients treated per CNS/CRNA/
 CNMs per year for Group 4......
                                 -------------------------------------------------------------------------------
    Patients treated by Group 4.  ..............  ..............  ..............           5,183           6,219
----------------------------------------------------------------------------------------------------------------
    Total Number of CNS/CRNA/                691           1,382           2,073           2,765           2,765
     CNMs obtaining DATA-waived
     status.....................
                                 -------------------------------------------------------------------------------
    Total Full-time-equivalent             5,183          11,402          18,657          26,949          31,095
     patients treated...........
----------------------------------------------------------------------------------------------------------------

    DEA used similar assumptions and calculation methods to determine 
how many FTE patients will be treated by NPs and PAs that remain DATA-
waived in years four and five of this analysis due to the SUPPORT Act 
providing permanent DATA-waiver eligibility. Only FTE patients treated 
in years four and five are relevant because even in the absence of the 
SUPPORT Act, NPs and PAs would be eligible for a DATA-waiver through 
September 30, 2021 (the end of year three of this analysis) due to the 
temporary authorization provided by CARA. DEA assumes that the 18,373 
DATA-waived NPs and PAs will treat, on average, 13.5 FTE patients in 
years four and five. Multiplying 18,373 by 13.5 results in an estimated 
248,036 FTE patients treated in years four and five due to the SUPPORT 
Act. The table below summarizes this analysis.

----------------------------------------------------------------------------------------------------------------
                                      Year 1          Year 2          Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Total Number of NP and PA         ..............  ..............  ..............          18,373          18,373
 remaining DATA-waived..........
Average full-time-equivalent      ..............  ..............  ..............            13.5            13.5
 patients treated per NP and PA
 per year.......................
                                 -------------------------------------------------------------------------------
    Total Full-time-equivalent    ..............  ..............  ..............         248,036         248,036
     patients treated...........
----------------------------------------------------------------------------------------------------------------

Economic Burden of Prescription Opioid Abuse
    The total U.S. economic burden (healthcare costs, criminal justice 
costs, and lost productivity costs) of prescription opioid abuse in 
2013 was estimated to be $78.5 billion.\32\ Lost productivity costs 
represented approximately 53 percent of the total economic burden, 
healthcare (including substance abuse treatment costs) represented 
approximately 37 percent of the total economic burden, and criminal 
justice costs represented approximately 10 percent of the total 
economic burden.\33\ This study estimated $78.5 billion ($85.2 billion 
in 2018) \34\ in total U.S. economic burden is based on the 1.935 
million opioid abuse patients reported by SAMHSA's National Survey on 
Drug Use and Health as meeting the Diagnostic and American Psychiatric 
Association's Statistical Manual of Mental Disorders (DSM-IV) criteria 
for abuse or dependence. Adjusting for substance abuse treatment costs 
included in the economic burden calculation (because the baseline level 
of substance abuse treatment cost is not

[[Page 69161]]

expected to decrease with more treatment), DEA estimates the total 
economic burden to be $75.7 billion ($82.14 billion USD in 2018).\35\ 
Dividing this total economic burden by the number of patients, DEA 
estimates the annual economic burden of prescription opioid abuse is 
$42,000 per person (USD in 2018).
---------------------------------------------------------------------------

    \32\ Florence CS, Zhou C, Luo F & Xu L, The Economic Burden of 
Prescription Opioid Overdose, Abuse, and Dependence in the United 
States, 2013, 54 Med Care 901 (2016). DEA's 2017 National Drug 
Threat Assessment (NDTA) also references this estimate for total 
economic burden of prescription drug abuse. No estimate of the 
economic burden of prescription opioid abuse is given in the most 
recent NDTA for 2018.
    \33\ Id.
    \34\ Adjusted to 2018 dollars using the GDP deflator published 
by the Federal Reserve Bank of St. Louis (https://fred.stlouisfed.org/series/GDPDEF, accessed on 8/15/2019). All 
figures given below are 2018 dollars unless otherwise indicated.
    \35\ The Council of Economic Advisers (CEA) reported that it 
estimates in 2015, the economic cost of opioid crisis was $504 
billion (``The Underestimated Cost of the Opioid Crisis,'' CEA, 
November, 2017). Among several differences in analysis methods, the 
CEA's estimate is based on all opioids (prescription and illegal), 
while Florence et al. reported cost of $78.5B is based only on 
prescription opioids. To limit the scope of this analysis to the 
economic burden of prescription opioid abuse and to be consistent 
with DEA's 2017 National Drug Threat Assessment, this analysis uses 
the Florence et al. estimated 2013 economic burden of $78.5B (or 
$82.14B after backing out baseline substance abuse treatment cost 
and adjusting for USD 2018).
---------------------------------------------------------------------------

Economic Burden Reduction
    Successful treatment of opioid abuse or dependence is expected to 
generate economic burden reductions. On November 8, 2011, the National 
Institutes of Health (NIH) announced the results of a large scale study 
on treatment of prescription opioid addiction. According to the 
announcement,

[r]esults showed that approximately 49 percent of participants reduced 
prescription painkiller abuse during extended (at least 12-week) 
Suboxone treatment. This success rate dropped to 8.6 percent once 
Suboxone was discontinued.\36\ Reductions in prescription painkiller 
abuse were seen regardless of whether or not the patient reported 
suffering chronic pain, and participants who received intensive 
addiction counseling did not show better outcomes when compared to 
those who did not receive this additional counseling.37 38
---------------------------------------------------------------------------

    \36\ This success rate was measured two months after treatment 
terminated.
    \37\ Painkiller Abuse Treated by Sustained Buprenorphine/
Naloxone, National Institutes of Health (November 8, 2011), https://www.nih.gov/news-events/news-releases/painkiller-abuse-treated-sustained-buprenorphine/naloxone.
    \38\ At an 18-month follow up study, it was found that many 
patients currently or recently re-engaged in opioid agonist therapy, 
and the abstinence rate was found to have rebounded to 51.2 percent. 
NIDA. Long-Term Follow-Up of Medication-Assisted Treatment for 
Addiction to Pain Relievers Yields ``Cause for Optimism.'' National 
Institute on Drug Abuse website. https://www.drugabuse.gov/news-events/nida-notes/2015/11/long-term-follow-up-medication-assisted-treatment-addiction-to-pain-relievers-yields-cause-optimism. 
November 30, 2015. Accessed August 15, 2019.
---------------------------------------------------------------------------

    DEA estimates a patient (or FTE) successfully undergoing treatment 
will generate an economic burden reduction of $42,000 annually.\39\ 
Based on the figures above, DEA estimates a success rate of 29 percent 
(average of 49 percent and 8.6 percent from above) in treating abuse 
and addiction, which would result in economic burden reductions.\40\ 
Several other studies have also shown that office-based buprenorphine 
treatment has 50-60 percent retention rates at 6-months.\41\
---------------------------------------------------------------------------

    \39\ DEA notes that the methodology presented here for 
calculating the benefits of treatment differs from the methodology 
employed by HHS in the final rule Medication Assisted Treatment for 
Opioid Use Disorders, published at 81 FR 44711, on July 8, 2016. HHS 
calculated the value of Quality Adjusted Life Years gained from 
treatment and applied this value to their estimated number of 
additional patients in treatment per year. HHS calculates the 
average annual benefit per new patient in treatment to be $51,000 
while assuming a 43.3 percent treatment completion rate for a 6-
month treatment course. For individuals that do not complete 
treatment, it is assumed that half of the annual benefits are 
realized.
    \40\ NIH's report describes that 49 percent and 8.6 percent 
``reduced'' abuse, not ``eliminated,'' suggesting the potential of 
reducing the $42,000 in economic burden, not eliminating the costs. 
DEA does not have a basis on which to quantify this reduction. 
However, considering that there are patients that are successfully 
treated and no longer under treatment, DEA believes a success rate 
of 29 percent for the overall patient population is a reasonable 
estimate. The success rate is applied to FTE patients (meaning 
patients under active treatment) in the following paragraph to 
estimate economic burden reduction,
    \41\ Advancing Access to Addiction Medications: Implications for 
Opioid Addiction Treatment. THE AMERICAN SOCIETY OF ADDICTION 
MEDICINE (June 2013). https://www.asam.org/docs/default-source/advocacy/aaam_implications-for-opioid-addiction-treatment_final.pdf?sfvrsn=cee262c2_25.
---------------------------------------------------------------------------

    Applying the $42,000 economic burden reduction and a success rate 
of 29 percent to the estimated 5,183, 11,402, 18,657, 274,985, and 
279,131 total FTE patients treated in years 1, 2, 3, 4, and 5, by all 
practitioners (NPs, PAs, CRNAs, CNS, and CNMs) respectively, the 
estimated total economic burden reduction is $63 million, $139 million, 
$227million, $3,349 million, and $3,400 million in years 1, 2, 3, 4, 
and 5, respectively. The table below summarizes this analysis.

----------------------------------------------------------------------------------------------------------------
                                      Year 1          Year 2          Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Full-time-equivalent patients              5,183          11,402          18,657         274,985         279,131
 treated........................
Economic burden reduction per              0.042           0.042           0.042           0.042           0.042
 patient ($MM)..................
Treatment success rate..........             29%             29%             29%             29%             29%
                                 -------------------------------------------------------------------------------
    Total economic burden                     63             139             227           3,349           3,400
     reduction ($MM)............
----------------------------------------------------------------------------------------------------------------
Figures are rounded.

Cost of Treatment
    As stated previously, this interim final rule does not directly 
impact the cost of treatment, however, the treatment is required to 
generate these economic burden reductions, and thus, included in this 
analysis. Research shows that the treatment period encompasses three 
phases: Induction, stabilization, and maintenance. The induction phase 
usually lasts about one week, with the goal of helping the patient 
discontinue or tremendously decrease the use of other opioids. 
Stabilization usually takes about one to two months. The patient is 
seen at least weekly, with the goal of finding the minimum dose 
necessary to treat the symptoms of opioid addiction. During the first 
two phases, it is recommended that a patient receives daily dosing. The 
final stage is the maintenance phase, which is also the longest, as it 
could be a lifetime process. During this phase, it is important to 
monitor and address social and family life, as well as cravings and 
other drug and alcohol use. At this point, a patient should be seen at 
less frequent intervals, but at least once a month.\42\
---------------------------------------------------------------------------

    \42\ McNicholas, M.D., Ph.D., Clinical Guidelines for the Use of 
Buprenorphine in the Treatment of Opioid Addiction, Substance Abuse 
and Mental Health Services Administration, https://store.samhsa.gov/shin/content/SMA05-4003/SMA05-4003.pdf.
---------------------------------------------------------------------------

    The National Institute on Drug Abuse estimates buprenorphine for a 
stable patient provided in a certified opioid treatment program, 
including medication and twice-weekly visits costs $115 per week or 
$5,980 per year.\43\ SAMHSA, in their final rule on MAT for opioid use 
disorders, estimated

[[Page 69162]]

the cost for buprenorphine and additional medical services, including 
behavioral health and psychosocial services, is $4,349 per patient per 
year ($4,852 USD in 2018).\44\ Based on the average of these estimates, 
DEA estimates the cost of buprenorphine treatment is $5,416 per year 
per FTE patient (USD in 2018). Public funds currently account for 90 
percent of substance abuse treatments in the United States.\45\ A 2015 
National Survey on Drug Use and Health study found that among 
individuals who sought, but did not receive treatment, 30 percent 
reported that they did not have insurance coverage and could not afford 
to pay for treatment.\46\ The costs of care, lack of insurance 
coverage, and shortage of treatment options deter some patients from 
seeking treatment. DEA also estimates the opportunity cost of treatment 
for the FTE patient to be $2,113 per year. This includes $302.48 in 
transportation costs and $1,810.34 of forgone wages (37 visits/year 
multiplied by loaded hourly wage of $24.46 multiplied by 2 hours of 
patient time/visit).\47\ Therefore, the estimated combined total cost 
of treatment is $7,529 per year per FTE patient. DEA assumes the 
funding of treatment cost will be available through private insurance, 
public assistance, private funds, or any combination thereof, to 
generate the economic burden reductions discussed above.
---------------------------------------------------------------------------

    \43\ How Much Does Opioid Treatment Cost?, National Institute on 
Drug Abuse, https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost (last updated June 2018). The base year was not 
provided for the cost figure, and thus is assumed to be in (or not 
materially different from) 2018 USD based on the date of the report.
    \44\ 81 FR 44712, 44732 (July 8, 2016).
    \45\ Note 30.
    \46\ https://addiction.surgeongeneral.gov/chapter-4-treatment.pdf. The 10 percent figure is for all diagnosed with 
substance use disorder, not specific to prescription opioids. 
Figures specific to prescription opioid substance use disorder is 
not available.
    \47\ For purpose of this analysis, the estimated typical number 
of visits for a 6-month period patient and multiplied by two to 
reflect the 37 FTE visits. The transportation cost of $302.48 is 
based on 2018 IRS mileage reimbursement rate of $0.545 per mile 
times an assumed 30 miles round-trip times 37 visits. The loaded 
hourly wage of $24.46 is based on the median hourly wages for 
Occupation Code 00-0000 All Occupations ($18.58). May 2018 National 
Occupational Employment and Wage Estimates, United States, BUREAU OF 
LABOR STATISTICS, https://www.bls.gov/oes/current/oes_nat.htm#00-0000 (last visited August 16, 2019). Average benefits for employees 
in private industry is 29.9 percent of total compensation. Employer 
Costs for Employee Compensation--June 18, 2019, BUREAU OF LABOR 
STATISTICS, https://www.bls.gov/news.release/pdf/ecec.pdf (last 
visited August 16, 2019). Adjusting for employer-paid legally 
required benefits, benefits are 22.2 percent (29.9 percent - 7.7 
percent). The 22.2 percent of total compensation equates to 31.67 
percent (22.2 percent/70.1 percent) load on wages and salaries. 
$18.58 x (1 + 0.3167) = $24.46.
---------------------------------------------------------------------------

    After applying the total treatment cost of $7,529 per year to the 
estimated 5,183; 11,402; 18,657; 274,985; and 279,131 FTE patients 
treated in years 1, 2, 3, 4, and 5, respectively, the estimated total 
cost of treatment is $39 million, $86 million, $140 million, $2,070 
million, and $2,102 million in years 1, 2, 3, 4, and 5, respectively. 
The table below summarizes this analysis.

----------------------------------------------------------------------------------------------------------------
                                      Year 1          Year 2          Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Full-time-equivalent patients              5,183          11,402          18,657         274,985         279,131
 treated........................
Annual cost of treatment per              0.0075          0.0075          0.0075          0.0075          0.0075
 patient ($MM)..................
                                 -------------------------------------------------------------------------------
    Cost of treatment ($MM).....              39              86             140           2,070           2,102
----------------------------------------------------------------------------------------------------------------
Figures are rounded.

Treatment Cost Savings
    DEA estimates that there will be cost savings from being able to 
dispense buprenorphine through NPs and PAs on a permanent basis, and 
through CNS, CRNAs, and CNMs on a temporary basis. Medicare reimburses 
NPs, PAs, and CNS at 85 percent of the rates for physicians under the 
Medicare Physician Fee Schedule (MPFS), while CRNAs and CNMs are 
reimbursed at 80 percent of the amount a physician is paid under the 
MPFS.\48\ While not all treatment is funded by Medicare, public funds 
currently account for 90 percent of substance abuse treatments in the 
United States.\49\ Based on the MPFS reimbursement rates, DEA estimates 
that MAT provided by NPs, PAs, CNS, CRNAs, and CNMs costs 17 percent 
\50\ less than treatment provided by physicians, resulting in a cost 
savings relative to the full cost of treatment in the baseline 
regulatory environment in which NPs and PAs lose DATA-waived status in 
year four, and DATA-waived physicians are the only providers of MAT in 
years four and five.
---------------------------------------------------------------------------

    \48\ Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, ``Advanced Practice Registered Nurses, 
Anesthesiologist Assistants, and Physician Assistants,'' October 
2016. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Medicare-Information-for-APRNs-AAs-PAs-Booklet-ICN-901623.pdf.
    \49\ Florence CS, Zhou C, Luo F & Xu L, The Economic Burden of 
Prescription Opioid Overdose, Abuse, and Dependence in the United 
States, 2013, 54 Med Care 901 (2016).
    \50\ (15 percent + 15 percent + 15 percent + 20 percent + 20 
percent)/5 = 17 percent.
---------------------------------------------------------------------------

    The treatment cost of $7,529 per FTE patient estimated in the 
previous section includes $2,113 in opportunity cost, which accounts 
for transportation costs and forgone wages. The remaining treatment 
cost of $5,416 includes the cost of medication and physician visits. 
Because physicians set their own rates, there is no standard price of 
an office visit for buprenorphine treatment, so comprehensive data are 
not available. However, according to an article published on 
www.suboxonedirectory.com, the initial evaluation appointment can range 
from $200-$300 per hour, while the induction appointment can range from 
$200-$400 per hour.\51\ After this, follow up appointments can cost 
$125-$250 per visit. DEA assumes that after the evaluation and 
induction visits, a buprenorphine patient will visit their doctor's 
office on a monthly basis. Taking the midpoint of these cost estimates, 
DEA estimates that the annual cost for buprenorphine treatment office 
visits to be $2,800.\52\ Seventeen percent savings on $2,800 equates to 
a savings of $476 for a total treatment cost of $7,053 ($7,529 - $476) 
per year.
---------------------------------------------------------------------------

    \51\ ``How Much Does Suboxone Cost?'' The Suboxone Directory. 
Accessed April 16, 2020. https://www.suboxone-directory.com/suboxone-treatment/how-much-does-suboxone-cost/.
    \52\ Evaluation ($250) + induction ($300) + 12 monthly visits 
($187.50 * 12) = $2,800.
---------------------------------------------------------------------------

    After applying the reduced total treatment cost of $7,053 per year 
to the estimated 5,183, 11,402, 18,657, 274,985, and 279,131 FTE 
patients treated in years 1, 2, 3, 4, and 5, respectively, the 
estimated total cost of treatment is $37 million, $81 million, $132 
million, $1,952 million, and $1,982 million in years 1, 2, 3, 4, and 5, 
respectively. These figures represent a treatment cost savings of $2 
million, $5 million, $8 million, $118 million, and $120 million in 
years 1, 2, 3, 4, and 5, respectively, or a total treatment cost 
savings of $253 million over five years. The table below summarizes 
this analysis.

[[Page 69163]]



----------------------------------------------------------------------------------------------------------------
                                       Year 1       Year 2       Year 3       Year 4       Year 5       Total
----------------------------------------------------------------------------------------------------------------
Baseline Cost of treatment ($MM)..           39           86          140        2,070        2,102
                                   -----------------------------------------------------------------------------
    Full-time-equivalent patients         5,183       11,402       18,657      274,985      279,131
     treated......................
    Reduced annual cost of               0.0071       0.0071       0.0071       0.0071       0.0071
     treatment per patient ($MM)..
                                   -----------------------------------------------------------------------------
        Reduced cost of treatment            37           81          132        1,952        1,982
         ($MM)....................
        Treatment Cost Savings              (2)          (5)          (8)        (118)        (120)        (253)
         from Baseline ($MM)......
----------------------------------------------------------------------------------------------------------------
Figures are rounded.

Cost of Obtaining DATA-Waived Status
    For the purposes of this analysis, DEA conservatively includes the 
cost of obtaining DATA-waived status as a cost of this interim final 
rule. Similar to the treatment cost, this cost is not a direct result 
of the rule, but necessary to generate the economic burden reductions. 
DEA considers only CRNAs, CNS, and CNMs to be relevant to this portion 
of the analysis since the estimated 18,373 NPs and PAs that retain the 
DATA-waived eligibility as a result of the SUPPORT Act would have 
incurred the cost of obtaining their DATA-waiver due to the temporary 
eligibility granted by CARA. Therefore, NPs and PAs are excluded from 
this portion of this analysis.
    To obtain DATA-waived status, the CRNA, CNS, or CNM first needs to 
meet SAMHSA's requirements and obtain approval from SAMHSA. In addition 
to being licensed under State law to prescribe schedule III, IV, or V 
medications for the treatment of pain and registered with DEA, the 
prospective DATA-waived CRNA, CNS, or CNM must obtain 24 hours of 
instruction in subject areas by training providers specified in CARA. 
Generally, once verified by SAMHSA, DEA is notified that a particular 
CRNA, CNS, or CNM meets all of the criteria. Then, upon successful 
completion of routine due diligence, DEA will issue a modified 
registration, which indicates ``DATA-waived'' status. There is no 
additional fee to DEA for the registration modification.
    In addition to 24 hours of training, DEA estimates an additional 
three hours of administrative tasks, such as signing up for training, 
receiving training certificates, applying for waivers with SAMHSA, etc. 
Using a loaded median hourly wage for CRNAs, CNS, and CNMs of 
$78.52,\53\ the 27 hours of training and administrative tasks equate to 
$2,119.93 per person. SAMHSA provides its courses free of charge. 
Rounding the $2,119.93 to $2,100 per CRNA, CNS, or CNM and applying it 
to the 691 applicants in years 1, 2, 3, 4, and 5, respectively, DEA 
estimates the total cost of obtaining DATA-waived status is $1 million, 
$1 million, $1 million, $1 million, and $0 in years 1, 2, 3, 4, and 5 
respectively. The table below summarizes this analysis.
---------------------------------------------------------------------------

    \53\ The average of the median hourly wages for Occupation Code, 
29-1151 Nurse Anesthetists ($80.75), 29-1161 Certified Nurse 
Midwives ($49.89), and 29-1141 Registered Nurses ($34.48) is $55.04. 
May 2018 National Occupational Employment and Wage Estimates, United 
States, Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_nat.htm (last visited August 15, 2019). DEA chose to average 
these occupational codes since they are all considered Advanced 
Practice Registered Nurses (APRN) because of their education, 
training, and duties. However, BLS does not differentiate between 
all Registered Nurses (RNs) and the more specialized CNS because 
there is no separate Standard Occupational Classification (SOC) code 
for CNS. Thus, wage data for Registered Nurses are used in their 
place. Average benefits for employees in private industry is 29.9 
percent of total compensation. Employer Costs for Employee 
Compensation--June 18, 2019, BUREAU OF LABOR STATISTICS, https://www.bls.gov/news.release/pdf/ecec.pdf (last visited August 16, 
2019). The 29.9 percent of total compensation equates to 42.7 
percent (29.9 percent/70.1 percent) load on wages and salaries. 
$55.04 x (1 + 0.427) = $78.52.

----------------------------------------------------------------------------------------------------------------
                                      Year 1          Year 2          Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Number of DATA-waived CRNAs,                 691             691             691             691
 CNS, or CNMs...................
Cost of obtaining DATA-waived             0.0021          0.0021          0.0021          0.0021
 status per NP/PA ($MM).........
                                 -------------------------------------------------------------------------------
    Total cost of obtaining DATA-              1               1               1               1               0
     waived status ($MM)........
----------------------------------------------------------------------------------------------------------------

Other Potential Costs
    DEA also examined the cost of compliance. Newly DATA-waived NPs, 
PAs, CRNAs, CNS, and CNMs would be required to comply with various 
treatment-related record keeping requirements, imposing additional 
costs. However, a portion of the patient visitation fee can be directly 
attributed to compliance costs. Therefore, these costs have been 
included in the cost of treatment; and therefore, recordkeeping 
compliance cost is excluded from this analysis.
Risk of Diversion
    The SUPPORT Act expands the number of DATA-waived practitioners 
able to treat up to 100 patients, the number of DATA-waived NPs and 
PAs, and the categories of practitioners, to include CRNAs, CNS, and 
CNMs, who may dispense FDA approved narcotic drugs in schedule III, IV, 
or V for the purpose of opioid maintenance or detoxification treatment. 
DEA understands that there is potential for the abuse of these drugs, 
which could be worsened by the expansion in the number and types of 
dispensers.
    Since office based opioid treatment with buprenorphine was 
introduced by the FDA in 2004, buprenorphine (Subutex) and 
buprenorphine combined with naloxone (Suboxone) have become widely 
available in the United States. With this availability has come 
increased reports of misuse and diversion of buprenorphine. Studies 
have shown that buprenorphine is primarily diverted from prescriptions

[[Page 69164]]

written for the treatment of addiction.\54\ However, the primary reason 
for prescription buprenorphine (Subutex) and buprenorphine combined 
with naloxone (Suboxone) diversion is the failure to access legitimate 
addiction treatment.\55\ This finding suggests that increasing, not 
limiting, buprenorphine treatment may be an effective response to the 
diversion of buprenorphine.\56\
---------------------------------------------------------------------------

    \54\ Lofwall MR and Havens JR, Inability to access buprenorphine 
treatment as a risk factor for using diverted buprenorphine, Drug 
Alcohol Dependence, Dec. 1, 2012.
    \55\ Id.
    \56\ Id.
---------------------------------------------------------------------------

    The diversion of buprenorphine for self-treatment is also supported 
by studies of abuse rates of buprenorphine (Subutex) and buprenorphine 
combined with naloxone (Suboxone). A study of abuse of buprenorphine 
and buprenorphine combined with naloxone by opioid-dependent research 
subjects showed a strong preference for buprenorphine (which does not 
include naloxone in the formula).\57\ This preference is notable 
because the naloxone blocks the agonist effect of the buprenorphine, 
and therefore users of buprenorphine with naloxone are less likely to 
experience euphoria from the drug.\58\ The low endorsement \59\ of the 
use of buprenorphine with naloxone and the low prescription rate of 
buprenorphine (without naloxone) in the United States indicates that 
the potential for abuse of these drugs is relatively low.\60\ Another 
study of untreated injection drug users found that three out of four 
respondents said their intended use of buprenorphine or buprenorphine 
combined with naloxone was to self-medicate for addiction and/or to 
treat withdrawal.\61\ While buprenorphine and buprenorphine combined 
with naloxone are schedule III narcotics with a potential for diversion 
and abuse, academic literature seems to indicate that the diversion is 
not motivated by addiction to buprenorphine, but rather as a method to 
treat opioid addiction problems.\62\ Additionally, since NPs, PAs, 
CRNAs, CNS, and CNMs seeking to obtain the authority to dispense under 
the SUPPORT Act already have the authority to dispense controlled 
substances, and the SUPPORT Act only allows them to treat a specific 
group of patients with specific ailments, and will often be done in 
collaboration with or under the supervision of a qualified physician, 
DEA believes any added risk as a result of this rule would not be 
significant.
---------------------------------------------------------------------------

    \57\ Martin, Judith, Providers' Clinical Support System for 
Medication Assisted Treatment Guidance, January 10, 2014. https://pcssnow.org/wp-content/uploads/2014/02/PCSS-MATGuidanceAdherence-diversion-bup.Martin.pdf.
    \58\ Id.
    \59\ ``Low endorsement'' means that the Suboxone is not as 
highly sought after because the naloxone in the formula acts as an 
antagonist to the buprenorphine, meaning patients cannot experience 
the euphoria from the drug.
    \60\ Id.
    \61\ Diversion and Abuse of Buprenorphine: A Brief Assessment of 
Emerging Indicators, JBS International, Inc., Maxwell, Jane C. 
November 30, 2006.
    \62\ Cicero, Theodore J., Matthew S. Ellis, and Howard D. 
Chilcoat. ``Understanding the Use of Diverted Buprenorphine.'' Drug 
and Alcohol Dependence 193 (2018): 117-23. https://doi.org/10.1016/j.drugalcdep.2018.09.007.
---------------------------------------------------------------------------

Cost to DEA
    As part of its core function, DEA's Diversion Control Division 
manages over 1.9 million DEA registrations (processing new and renewal 
registration applications, processing registration modification 
requests, issuing certificates of registration, issuing renewal 
notifications, conducting due diligence, maintaining and operating 
supporting information systems, etc.). DEA does not anticipate it will 
incur any additional costs as a result of conducting due diligence and 
processing 19,659 registration modifications for DATA-waived status 
over five years. DEA's Registration Section and field office 
representatives conduct similar registration-related due diligence and 
process registration modifications as part of their routine operations. 
As of August 2019, DEA has absorbed any extra work in processing over 
5,600 registration modifications related to this interim final rule 
with preexisting resources, without an increase in cost to DEA. 
Likewise, DEA anticipates it will continue to absorb any additional 
work in processing the registration modifications for the duration of 
the analysis period.
Summary of Benefits and Costs
    As described above, DEA estimates the total benefit (in the form of 
economic burden reduction and other cost savings) is $63 million, $139 
million, $227 million, $3,349 million, and $3,400 million in years 1, 
2, 3, 4, and 5, respectively; the total cost of treatment is $39 
million, $86 million, $140 million, $2,070 million, and $2,102 million 
in years 1, 2, 3, 4, and 5, respectively; the total treatment cost 
savings is $2 million, $5 million, $8 million, $118 million, and $120 
million in years 1, 2, 3, 4, and 5, respectively; and the total cost of 
obtaining DATA-waived status is $1 million, $1 million, $1 million, $1 
million, and $0 in years 1, 2, 3, 4, and 5, respectively; resulting in 
a net benefit of $25 million, $57 million, $94 million, $1,396 million, 
and $1,418 million in years 1, 2, 3, 4, and 5, respectively. The table 
below summarizes the benefits and costs.

----------------------------------------------------------------------------------------------------------------
                                      Year 1          Year 2          Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Total benefit ($MM).............              63             139             227           3,349           3,400
                                 -------------------------------------------------------------------------------
    Cost of treatment ($MM).....              39              86             140           2,070           2,102
    Treatment cost savings ($MM)             (2)             (5)             (8)           (118)           (120)
    Cost of obtaining DATA-                    1               1               1               1  ..............
     waived status ($MM)........
                                 -------------------------------------------------------------------------------
        Total cost ($MM)........              38              82             133           1,953           1,982
                                 -------------------------------------------------------------------------------
            Annual net benefit                25              57              94           1,396           1,418
             ($MM)..............
----------------------------------------------------------------------------------------------------------------
Figures are rounded.

    DEA recognizes that accurately calculating the benefits of this 
rule rests primarily on the number of FTE patients in treatment. While 
DEA considers its primary estimates presented above to be reasonable, 
there are also inherent uncertainties in predicting these figures over 
time. Therefore, DEA varied its estimated number of FTE patients 
treated per provider plus and minus 10 percent in order to capture the 
likely range of benefits surrounding the primary estimate. These 
results are detailed in the following table. The impact of varying 
additional inputs are summarized in the sensitivity analysis section 
below.

[[Page 69165]]



----------------------------------------------------------------------------------------------------------------
                                      Year 1          Year 2          Year 3          Year 4          Year 5
----------------------------------------------------------------------------------------------------------------
Total benefit ($MM).............           57-69         125-153         205-250     3,014-3,684     3,060-3,740
                                 -------------------------------------------------------------------------------
    Cost of treatment ($MM).....           35-43           77-94         126-155     1,863-2,277     1,891-2,312
    Treatment cost savings ($MM)         (2)-(3)         (4)-(5)         (7)-(9)     (106)-(129)     (107)-(132)
    Cost of obtaining DATA-                    1               1               1               1  ..............
     waived status ($MM)........
                                 -------------------------------------------------------------------------------
        Total cost ($MM)........           34-41           74-90         120-147     1,758-2,149     1,784-2,180
                                 -------------------------------------------------------------------------------
            Annual net benefit             23-28           51-63          85-103     1,256-1,535     1,276-1,560
             ($MM)..............
----------------------------------------------------------------------------------------------------------------

    At a 3 percent discount rate, the present value of benefits is 
$6,308 million, the present value of costs is $3,681 million and the 
net present value (NPV) is $2,627 million. At a 7 percent discount 
rate, the present value of benefits is $5,345 million, the present 
value of costs is $3,119 million and the NPV is $2,226 million.\63\ The 
net benefits in years one to five equate to an annualized net benefit 
of $574 million at 3 percent discount rate and $543 million at 7 
percent discount rate over five years. The table below summarizes the 
present value and annualized benefit calculations.
---------------------------------------------------------------------------

    \63\ See Office of Mgmt. & Budget, Exec. Office of the 
President, OMB Circular A-4, Regulatory Analysis (2003).

------------------------------------------------------------------------
                                                3%              7%
------------------------------------------------------------------------
Present value of benefits ($MM).........           6,308           5,345
Present value of costs ($MM)............           3,681           3,119
                                         -------------------------------
    Net present value ($MM).............           2,627           2,226
    Annualized net benefit--5 years                  574             543
     ($MM)..............................
------------------------------------------------------------------------
Figures are rounded.

    Consistent with OMB's Guidance for E.O. 13771,\64\ DEA assessed the 
costs and cost savings directly attributable to this rule. The costs 
directly attributable to this rule are the cost to CNS/CRNA/CNMs of 
obtaining DATA-waived status. The cost savings directly attributable to 
this rule are the reduction in costs that result from NPs, PAs, CNS, 
CRNAs, and CNMs providing MAT rather than physicians. Both are 
discussed in detail above. Below is a summary of the present value of 
net costs attributable to this interim final rule, with the annualized 
net cost figure adjusted to 2016 dollars.
---------------------------------------------------------------------------

    \64\ Office of Mgmt. & Budget, Exec. Office of the President, 
OMB Memorandum M-17-21, Implementing Executive Order 13771, Titled 
``Reducing Regulation And Controlling Regulatory Costs'' 10 (2017).

------------------------------------------------------------------------
                                                3%              7%
------------------------------------------------------------------------
Present value of costs ($MM)............               4               3
Present value of cost savings ($MM).....           (219)           (185)
                                         -------------------------------
    Net present value ($MM).............           (215)           (182)
    Annualized net costs--5 years ($MM).            (44)            (42)
------------------------------------------------------------------------

    The annualized net cost savings from this rulemaking will be $44 
million at a 3 percent discount rate and $42 million at a 7 percent 
discount rate over the next five years.
Sensitivity Analysis
    The five-year net benefit and the associated NPV are sensitive to 
the assumptions and estimates for variables that were factored into the 
calculation. The variables are:
     Number of DATA-waived NPs, PAs, CRNAs, CNS, and CNMs.
     Number of FTE patients treated per NP/PA.
     Economic burden reduction per patient.
     Treatment success rate.
     Annual cost of treatment per patient.
     Cost of obtaining DATA-waived status.
    Sensitivity analysis was conducted by adjusting the variables up 
and down by 10 percent and recording the change in the NPV. The NPV was 
most sensitive to the change in the number of DATA-waived 
practitioners, the economic burden reduction per patient, and the 
treatment success rate. A 10 percent change in these variables resulted 
in a 23 percent to 24 percent change in the NPV. The NPV was the least 
sensitive to the change in cost of obtaining DATA-waived status. A 10 
percent change resulted in minimal change in the NPV. The remaining 
variables were moderately sensitive. A 10 percent change in the annual 
cost of treatment resulted in a 14 percent change in the NPV, while a 
10 percent change in the number of FTE patients treated per provider 
resulted in a 10 percent change in the NPV, respectively.
    The table below summarizes the sensitivity analysis.

[[Page 69166]]



----------------------------------------------------------------------------------------------------------------
                                         NPV ($MM), 3% discount rate            NPV ($ MM), 7% discount rate
             Variables             -----------------------------------------------------------------------------
                                      10% less       Base       10% more     10% less       Base       10% more
----------------------------------------------------------------------------------------------------------------
Number of DATA-waived NPs, PAs,           2,024        2,627        3,221        1,714        2,226        2,729
 CRNAs, CNS, and CNMs.............
Percent of Base...................          77%          N/A         123%          77%          N/A         123%
----------------------------------------------------------------------------------------------------------------
Number of Full-time-equivalent            2,365        2,627        2,890        2,003        2,226        2,448
 patients treated Practitioner....
Percent of Base...................          90%          N/A         110%          90%          N/A         110%
----------------------------------------------------------------------------------------------------------------
Economic burden reduction per             1,997        2,627        3,258        1,692        2,226        2,760
 patient..........................
Percent of Base...................          76%          N/A         124%          76%          N/A         124%
----------------------------------------------------------------------------------------------------------------
Treatment success rate............        1,997        2,627        3,258        1,692        2,226        2,760
Percent of Base...................          76%          N/A         124%          76%          N/A         124%
----------------------------------------------------------------------------------------------------------------
Annual cost of treatment per              2,995        2,627        2,259        2,537        2,226        1,914
 patient..........................
Percent of Base...................         114%          N/A          86%         114%          N/A          86%
----------------------------------------------------------------------------------------------------------------
Annual cost of obtaining DATA-            2,627        2,627        2,623        2,226        2,226        2,223
 waived status....................
Percent of Base...................         100%          N/A         100%         100%          N/A         100%
----------------------------------------------------------------------------------------------------------------

Executive Order 12988, Civil Justice Reform

    This interim final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards, and reduce burden.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The interim final rule does 
not have substantial direct effects on the States, on the relationship 
between the National Government and the States, or the distribution of 
power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This interim final rule does not have substantial direct effects on 
the States, on the relationship between the National Government and the 
States, or the distribution of power and responsibilities between the 
Federal Government and Indian tribes.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA. As explained above, DEA determined that there was good cause 
to exempt this interim final rule from notice and comment. 
Consequently, the RFA does not apply to this interim final rule.

Unfunded Mandates Reform Act of 1995

    This interim final rule will not 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 for inflation) in any 
one year, and will not significantly or uniquely affect small 
governments. Therefore, no actions were deemed under the provisions of 
the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532.

Congressional Review Act

    This rule is a major rule as defined by the Congressional Review 
Act. 5 U.S.C. 804. This rule will result in an annual effect on the 
economy of $100 million or more as a result of economic burden 
reductions. However, it will not cause a major increase in costs or 
prices; or significant adverse effects on competition, employment, 
investment, productivity, innovation, or on the ability of the United 
States-based companies to compete with foreign based companies in 
domestic and export markets. DEA has submitted a copy of this interim 
final rule to both Houses of Congress and to the Comptroller General.

Paperwork Reduction Act of 1995

    This action does not impose a new nor modify an existing collection 
of information requirement under the Paperwork Reduction Act of 1995. 
44 U.S.C. 3501-3521.

List of Subjects

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

21 CFR Part 1306

    Drug traffic control, Prescription drugs.

    For the reasons set out above, this DEA interim final rule amends 
21 CFR parts 1301 and 1306 as follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1301 continues to read as 
follows:

    Authority:  21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.


0
2. In Sec.  1301.28:
0
a. Revise the first sentence in paragraph (b)(1)(i);
0
b. Revise (b)(1)(iii)(B); and
0
c. Remove paragraph (b)(1)(iii)(C).
    The revisions read as follows:


Sec.  1301.28  Exemption from separate registration for practitioners 
dispensing or prescribing Schedule III, IV, or V narcotic controlled 
drugs approved by the Food and Drug Administration specifically for use 
in maintenance or detoxification treatment.

* * * * *
    (b)(1) * * *
    (i) The individual practitioner is registered under Sec.  1301.13 
as an individual practitioner and is a ``qualifying physician'' as 
defined in section 303(g)(2)(G)(ii) of the Act (21 U.S.C. 
823(g)(2)(G)(ii)); a ``qualifying other practitioner'' as defined in 
section 303(g)(2)(G)(iv) of the Act (21 U.S.C. 823(g)(2)(G)(iv)) who is 
a nurse practitioner or physician assistant; or during the period 
beginning on October 1, 2018 and ending on October 1, 2023, a 
``qualifying other practitioner'' as defined in section 
303(g)(2)(G)(iv) of the

[[Page 69167]]

Act (21 U.S.C. 823(g)(2)(G)(iv)) who is clinical nurse specialist, 
certified registered nurse anesthetist, or certified nurse midwife. * * 
*
* * * * *
    (iii) * * *
    (B) The applicable number is--
    (1) 100 if not sooner than 1 year after the date on which the 
practitioner submitted the initial notification, the practitioner 
submits a second notification to the Secretary of Health and Human 
Services of the need and intent of the practitioner to treat up to 100 
patients;
    (2) 100 if the practitioner holds additional credentialing, as 
defined in 42 CFR 8.2;
    (3) 100 if the practitioner provides medication-assisted treatment 
using covered medications (as such terms are defined in 42 CFR 8.615) 
in a qualified practice setting (as described in 42 CFR 8.615); and
    (4) 275 if the practitioner meets the requirements specified in 42 
CFR 8.610 through 8.655.
* * * * *

PART 1306--PRESCRIPTIONS

0
3. The authority citation for 21 CFR part 1306 is revised to read as 
follows:

    Authority:  21 U.S.C. 821, 823, 829, 829a, 831, 871(b) unless 
otherwise noted.


0
4. In Sec.  1306.04, add paragraph (d) to read as follows:


Sec.  1306.04  Purpose of issue of prescription.

* * * * *
    (d) A prescription may be issued by a qualifying practitioner, as 
defined in section 303(g)(2)G)(iii) of the Act (21 U.S.C. 
823(g)(2)(G)(iii), in accordance with Sec.  1306.05 for a Schedule III, 
IV, or V controlled substance for the purpose of maintenance or 
detoxification treatment for the purposes of administration in 
accordance with section 309A of the Act (21 U.S.C. 829a) and Sec.  
1306.07(f). Such prescription issued by a qualifying practitioner shall 
not be used to supply any practitioner with a stock of controlled 
substances for the purpose of general dispensing to patients.

0
5. In Sec.  1306.07, add a reserved paragraph (e) and paragraph (f) to 
read as follows:


Sec.  1306.07  Administering or dispensing of narcotic drugs

* * * * *
    (f) Notwithstanding the definition of dispense under section 
102(10) of the Act (21 U.S.C 802(10)), a pharmacy may deliver a 
controlled substance to a practitioner, pursuant to a prescription that 
meets the requirements under Sec.  1306.04 for the purpose of 
administering the controlled substance by the practitioner if:
    (1) The controlled substance is delivered by the pharmacy to the 
prescribing practitioner or the practitioner administering the 
controlled substance, as applicable, at the location, listed on the 
practitioner's certificate of registration;
    (2) The controlled substance is to be administered for the purpose 
of maintenance or detoxification treatment under section 
303(g)(2)(G)(iii) of the Act (21 U.S.C. 823(g)(2)(G)(iii)); and
    (i) The practitioner who issued the prescription is a qualifying 
practitioner as defined in section 303(g) of the Act (21 U.S.C. 
823(g)); and
    (ii) The controlled substance is to be administered by injection or 
implantation;
    (3) The pharmacy and the practitioner are authorized to conduct 
such activities specified in this paragraph (f) under the law of the 
State in which such activities take place;
    (4) The prescription is not issued to supply any practitioner with 
a stock of controlled substances for the purpose of general dispensing 
to patients;
    (5) The controlled substance is to be administered only to the 
patient named on the prescription not later than 14 days after the date 
of receipt of the controlled substance by the practitioner; and
    (6) Notwithstanding any exceptions under section 307 of the Act (21 
U.S.C. 827), the prescribing practitioner, and the practitioner 
administering the controlled substance, as applicable, shall maintain 
complete and accurate records of all controlled substances delivered, 
received, administered, or otherwise disposed of, under this paragraph 
(f), including the persons to whom the controlled substances were 
delivered and such other information as may be required under this 
chapter.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-23813 Filed 10-29-20; 4:15 pm]
BILLING CODE 4410-09-P