[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Proposed Rules]
[Pages 17639-17662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 8

RIN 0930-AA22


Medication Assisted Treatment for Opioid Use Disorders

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

ACTION: Proposed rule.

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SUMMARY: The Secretary of the Department of Health and Human Services 
(the Secretary) (HHS) proposes a rule to increase the highest patient 
limit for qualified physicians to treat opioid use disorder under 
section 303(g)(2) of the Controlled Substances Act (CSA) from 100 to 
200. The purpose of the proposed rule is to increase access to 
treatment for opioid use disorder while reducing the opportunity for 
diversion of the medication to unlawful use.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on May 31, 2016.

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

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

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose
    B. Summary of Major Provisions
    C. Summary of Impacts
II. Public Participation
III. Background
    A. Opioid Use Disorder
    B. Medication-Assisted Treatment
    C. Statutory and Rulemaking History
    D. Current Process for Obtaining a Practitioner Waiver Under 21 
U.S.C. 823(g)(2)
    E. Evaluations of the Current System
    F. Need for Rulemaking
IV. Summary of Proposed Rule
    A. General
    B. Scope (Sec.  8.1)
    C. Definitions (Sec.  8.2)
    D. Opioid Treatment Programs (Sec. Sec.  8.3-8.4)
    E. Which practitioners are eligible for a patient limit of 200? 
(Sec.  8.610)
    F. What constitutes a qualified practice setting? (Sec.  8.615)
    G. What is the process to request a patient limit of 200? (Sec.  
8.620)
    H. How will a request for patient limit increase be processed? 
(Sec.  8.625)
    I. What must practitioners do in order to maintain their 
approval to treat up to 200 patients under Sec.  8.625? (Sec.  
8.630)
    J. What are the reporting requirements for practitioners whose 
request for patient limit increase is approved under Sec.  8.625? 
(Sec.  8.635)
    K. What is the process for renewing a practitioner's request for 
patient limit increase approval? (Sec.  8.640)
    L. What are the responsibilities of practitioners who do not 
submit a renewal request for patient limit increase or whose request 
is denied? (Sec.  8.645)
    M. Can SAMHSA suspend or revoke a practitioner's patient limit 
increase approval? (Sec.  8.650)
    N. Can a practitioner request to temporarily treat up to 200 
patients in emergency situations? (Sec.  8.655)
V. Collection of information requirements
VI. Regulatory Impact Analysis
    A. Introduction
    B. Summary of the Proposed Rule
    C. Need for the Proposed Rule
    D. Analysis of Benefits and Costs
    E. Sensitivity Analysis
    F. Analysis of Regulatory Alternatives
    G. Regulatory Flexibility Analysis
VII. Agency Questions for Comment

Acronyms

ASAM American Society of Addiction Medicine
CFR Code of Federal Regulations
CSA Controlled Substances Act
DEA Drug Enforcement Administration
FDA Food and Drug Administration
FR Federal Register
HHS Department of Health and Human Services
HIV Human Immunodeficiency Virus
MAT Medication-Assisted Treatment
NOI Notification of Intent
NPRM Notice of Proposed Rulemaking
OTP Opioid Treatment Program

[[Page 17640]]

QA Quality Assurance
QI Quality Improvement
RFA Regulatory Flexibility Act
SAMHSA Substance Abuse and Mental Health Services Administration
U.S.C. United States Code

I. Executive Summary

A. Purpose

    The purpose of this proposed rule is to expand access to 
medication-assisted treatment (MAT) by allowing eligible practitioners 
to request approval to treat up to 200 patients under section 303(g)(2) 
of the Controlled Substances Act (CSA). The rulemaking also includes 
requirements to ensure that patients receive the full array of services 
that comprise evidence-based MAT and minimize the risk that the 
medications provided for treatment are misused or diverted. We hope 
that this proposed rule will stimulate broader availability of high-
quality MAT both in specialized addiction treatment settings and 
throughout more mainstream health care delivery systems.
    Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows 
individual practitioners to dispense or prescribe Schedule III, IV, or 
V controlled substances that have been approved by the Food and Drug 
Administration (FDA) for use in maintenance and detoxification 
treatment without registering as an opioid treatment program (OTP). 
Currently, the only FDA-approved medications that meet this standard 
are buprenorphine and the combination buprenorphine/naloxone 
(hereinafter referred to as buprenorphine). Buprenorphine is a schedule 
III controlled substance under the CSA. The CSA also imposes a limit on 
the number of patients a practitioner may treat with certain types of 
FDA-approved narcotic drugs, such as buprenorphine, at any one time. 
Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is authorized to 
change this patient limit by regulation at any one time.
    Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners 
who file an initial notification of intent (NOI) to treat a maximum of 
30 patients at a time. After 1 year, the practitioner may file a second 
NOI indicating his/her intent to treat up to 100 patients at a time. To 
qualify to treat any patients with buprenorphine, the practitioner must 
be a physician, possess a valid license to practice medicine, be a 
registrant of the Drug Enforcement Administration (DEA), have the 
capacity to refer patients for appropriate counseling and other 
necessary ancillary services, and have completed required training. As 
specified in the statute, the training requirement may be satisfied in 
several ways: One may hold subspecialty board certification in 
addiction psychiatry from the American Board of Medical Specialties or 
addiction medicine from the American Osteopathic Association; hold an 
addiction certification from the American Society of Addiction Medicine 
(ASAM); complete an 8-hour training provided by an approved 
organization; have participated as an investigator in one or more 
clinical trials leading to the approval of a medication that qualifies 
to be prescribed under 21 U.S.C. 823(g)(2); or complete other training 
or have such other experience as the State medical licensing board or 
the Secretary considers to demonstrate the ability of the physician to 
treat and manage persons with opioid use disorder.
    Access to MAT has been subject to patient limits via the provisions 
contained in the CSA and enforced by DEA. Since 21 U.S.C. 823(g)(2) was 
originally modified by legislation in 2000 to allow the provision of 
MAT without registering as an OTP, additional modifications have been 
made to address the application of the patient limit in group medical 
practices and to create a higher patient limit for practitioners with 1 
year of experience. These changes, while important, have not proven 
sufficient to support the development of adequate treatment capacity to 
keep pace with the growth of the national crisis of opioid misuse and 
overdose. To the extent that the current patient limit contributes to 
this access challenge, this proposed rule seeks to make a useful change 
in an effort to improve access.

B. Summary of Major Provisions

    The proposed rule would revise the highest patient limit from 100 
patients per practitioner with an existing waiver (waivered 
practitioner) to 200 patients for practitioners who meet certain 
criteria. Practitioners who have a waiver to treat 100 patients for at 
least 1 year would be eligible to apply for a waiver to treat up to 200 
patients if they possess a subspecialty board certification in 
addiction medicine or addiction psychiatry or practice in a qualified 
practice setting as defined in this proposed rule. In either case, 
practitioners with the higher limit of 200 would also be required to 
accept greater responsibility for ensuring behavioral health services 
and care coordination are received and for ensuring quality assurance 
and improvement practices, diversion control, and continuity of care in 
emergencies. The higher limit would also carry with it the duty to 
regularly reaffirm the practitioner's ongoing eligibility and to 
participate in data reporting and monitoring as required by SAMHSA. In 
addition, practitioners in good standing with a current waiver to 
prescribe to up to 100 patients (i.e., the practitioner has filed an 
NOI and satisfied all required criteria) could request the higher limit 
in emergency situations for a limited time period. SAMHSA would review 
all emergency situation requests in consultation, to the extent 
practicable, with appropriate governmental authorities before such 
requests would be granted.

C. Summary of Impacts

    The proposed rule is intended to increase access to MAT for some 
patients with an opioid use disorder, providing them with a path to 
recovery; reduce costs across different sectors (e.g. health care, 
criminal justice, and social service); and, ultimately, reduce the 
number of opioid-related overdose deaths. From 2016-2020, present value 
benefits of $11,019 million and annualized benefits of $2,336 million 
are estimated using a 3 percent discount rate; present value benefits 
of $10,148 million and annualized benefits of $2,313 million are 
estimated using a 7 percent discount rate. Present value costs of $955 
million and annualized costs of $202 million are estimated using a 3 
percent discount rate; present value costs of $880 million and 
annualized costs of $201 million are estimated using a 7 percent 
discount rate.

II. Public Participation

Comments Invited

    HHS invites interested parties to submit comments on all aspects of 
the proposed rule. When submitting comments, please reference a 
specific portion of the proposed rule, provide an explanation for any 
recommended change, and include supporting data. Specific agency 
questions for comment are listed in section VII. Comments responding to 
these questions should reference them by number.
    All comments received before the close of the comment period are 
available for viewing by the public, including any personally 
identifiable and/or confidential information that is included in a 
comment. We post all comments received as soon as possible after they 
have been received on the following Web site: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.

[[Page 17641]]

    Comments received before the close of the comment period will also 
be available for public inspection, generally beginning approximately 3 
weeks after publication of the proposed rule, at the headquarters of 
the Substance Abuse and Mental Health Services Administration, 5600 
Fishers Lane, Rockville, Maryland 20857, Monday through Friday of each 
week from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view 
public comments, call 240-276-1660.
    We will consider all comments we receive by the date and time 
specified in the DATES section of this preamble, and will respond to 
the comments in the preamble of the final rule. Please allow sufficient 
time for mailed comments to be received before the close of the comment 
period.

III. Background

A. Opioid Use Disorder

    Substance use disorder is a treatable chronic disease caused by 
changes to the structure and function of the brain due to exposure to 
intoxicating substances.\1\ Most of these substances alter the brain by 
increasing the release of the neurotransmitter dopamine, which plays an 
important role in the brain's reward system.\2\ Chronic exposure to 
drugs disrupts the way the brain controls both life-sustaining 
behaviors and those related to drug use.\3\ Opioid use disorder is a 
type of substance use disorder that has the added complexity of 
disrupting the naturally occurring function of endorphins throughout 
the body.\4\ This is what underlies the rapid formation of dependence 
and tolerance, and the withdrawal syndrome typically observed when 
opioid use is discontinued.\5\ The cycle of tolerance and withdrawal 
leads persons dependent on opioids to take larger doses, seek more 
potent opioids, or adopt methods of administration, such as injection, 
to intensify the opioid's effects.6 7 The possibility of 
experiencing euphoria, while an element of drug initiation, becomes 
more and more remote as the euphoric feelings experienced become less 
pleasurable and use of the drug becomes necessary for the user to feel 
``normal''.\8\ As a result, most opioid dependent persons must continue 
to use opioids in order to maintain function and to forestall the 
painful symptoms of withdrawal.\9\
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    \1\ The Science of Drug Abuse and Addiction: The Basics. (2014, 
September 1). Retrieved from: http://www.drugabuse.gov/publications/media-guide/science-drug-abuse-addiction-basics.
    \2\ National Institute on Drug Abuse (2014). Drugs, brains, and 
behavior: The science of addiction. (NIH Pub No. 14-5605). Retrieved 
from: https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/soa_2014.pdf.
    \3\ Id.
    \4\ National Institute on Drug Abuse. Impacts of Drugs on 
Neurotransmission. Retrieved from: http://www.drugabuse.gov/news-events/nida-notes/2007/10/impacts-drugs-neurotransmission.
    \5\ Id.
    \6\ Kosten, T.R., & George, T.P. (2002). The Neurobiology of 
Opioid Dependence: Implications for Treatment. Science & Practice 
Perspectives, 1(1), 13-20.
    \7\ Peavy, K.M., Banta-Green, C.J., Kingston, S., Hanrahan, M., 
Merrill, J.O., & Coffin, P.O. (2012). ``Hooked on'' prescription-
type opiates prior to using heroin: Results from a survey of syringe 
exchange clients. Journal of Psychoactive Drugs, 44(3), 259-265.
    \8\ National Institute on Drug Abuse, supra note 2.
    \9\ Id.
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    Opioid use disorder is essentially the same phenomenon. The 
potential for addiction and the symptoms of tolerance and withdrawal 
are very similar, whether the opioid is heroin or a prescription pain 
reliever, such as oxycodone or hydrocodone, because the brain responds 
to all opioids similarly. Untreated opioid dependence is associated 
with adoption of high-risk opioid use behaviors.10 11 12 A 
person who is no longer able to avoid withdrawal with the amount of 
opioid he or she is accustomed to or can afford to buy may transition 
to using opioids by injection, for example, because this route of 
administration can more quickly and efficiently deliver the drug to the 
brain via injection into the bloodstream rather than through the 
digestive tract.13 14 However, use of opioids by injection 
carries additional risks of infection with hepatitis C virus and human 
immunodeficiency virus (HIV), local and systemic infections, 
cardiovascular and respiratory problems, and higher overdose 
risk.15 16 17
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    \10\ Peavy, supra note 7.
    \11\ Jones, C.M. (2013). Heroin use and heroin use risk 
behaviors among nonmedical users of prescription opioid pain 
relievers, United States, 2002-2004 and 2008-2010. Drug and Alcohol 
Dependence, 132(1-2):95-100.
    \12\ Lankenau, S.E., Teti, M., Silva, K., Bloom, J.J., 
Harocopos, A., & Treese, M. (2012). Initiation into prescription 
opioid misuse amongst young injection drug users. International 
Journal of Drug Policy, 23(1), 37-44.
    \13\ Peavy, supra note 7.
    \14\ Drug Delivery Methods (2015). Retrieved from http://learn.genetics.utah.edu/content/addiction/delivery/.
    \15\ National Institute on Drug Abuse (2014). Heroin (Number 15-
0165). Retrieved from: https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/heroinrrs_11_14.pdf.
    \16\ Bruneau, J., Roy, E., Arrunda, N., Zang, G., & Jutras-
Aswad, D. (2012). The rising prevalence of prescription opioid 
injection and its association with hepatitis C incidence among 
street-drug users. Addiction, 107(7):1318-27.
    \17\ Conrad, C., Bradley, H.M., Broz, D., Buddha, S., Chapman, 
E.L., Galang, R.R., Duwve, J.M. (2015). Community outbreak of HIV 
infection linked to injection drug use of oxymorphone--Indiana, 
2015. Morbidity and Mortality Weekly Report, 64(16): 443-44.
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    The majority of these individuals do not recognize that repeated 
use of opioids, albeit legitimate, may increase the risk of developing 
an opioid use disorder, which may lead some individuals to switch from 
prescription drugs to cheaper and more risky substitutes like heroin. 
Based on combined 2014 National Survey on Drug Use and Health data, 
there are 1.9 million people aged 12 or older with a past-year pain 
reliever use disorder and 539,000 people with a past-year heroin use 
disorder.
    As many as 86 percent of persons who met diagnostic criteria for 
opioid use disorder in 2014 could be classified as dependent on 
opioids.\18\ In addition to changing the structure and function of the 
brain, when a person has dependence, the whole body has adapted to the 
presence of the opioid and does not function properly when the 
substance is absent, thus making it extremely difficult to discontinue 
use without formal treatment.\19\ Many people with opioid dependence 
who undergo detoxification in order to stop using opioids subsequently 
relapse to opioid use.\20\ As many as 95 percent of patients who 
undergo detoxification only, relapse to opioid use within 
weeks.21 22
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    \18\ Substance Abuse and Mental Health Services Administration 
(2015). Prescription drug misuse and abuse. Retrieved from: http://www.samhsa.gov/prescription-drug-misuse-abuse.
    \19\ Definition of dependence. (2007). Retrieved from: http://www.drugabuse.gov/publications/teaching-packets/neurobiology-drug-addiction/section-iii-action-heroin-morphine/8-definition-dependence.
    \20\ Kleber, H. D. (2007). Pharmacologic treatments for opioid 
dependence: detoxification and maintenance options. Dialogues in 
Clinical Neuroscience, 9(4), 455-470. National Institute on Drug 
Abuse. Patients Addicted to Opioid Painkillers Achieve Good Results 
With Outpatient Detoxification. Retrieved from: http://www.drugabuse.gov/news-events/nida-notes/2015/02/patients-addicted-to-opioid-painkillers-achieve-good-results-outpatient-detoxification 
on December 12, 2015.
    \21\ Ling, W., Amass, L., Shoptaw, S., Annon, J.J., Hillhouse, 
M., Babcock, D., Brigham, G., Harrer, J., Reid, M., Muir, J., 
Buchan, B., Orr, D., Woody, G., Krejci, J., Ziedonis, D., Group, the 
B.S.P. (2005). A multi-center randomized trial of buprenorphine-
naloxone versus clonidine for opioid detoxification: findings from 
the National Institute on Drug Abuse Clinical Trials Network. 
Addiction (Abingdon, England), 100(8), 1090-1100.
    \22\ Weiss, R.D., Potter, J.S., Fiellin, D.A., Byrne, M., 
Connery, H.S., Dickinson, W., Gardin, J., Griffin, L.M., Gourevitch, 
N.M., Haller, D., Hasson, A., Huang, Z., Jacobs, P., Kosinski, S.A., 
Lindblad, R., McCance-Katz, F.E., Provost, E.S., Selzer, J., Somoza, 
C.E., Sonne, C.S., Ling, W. (2011). Adjunctive Counseling During 
Brief and Extended Buprenorphine-Naloxone Treatment for Prescription 
Opioid Dependence: A 2-Phase Randomized Controlled Trial. Archives 
of General Psychiatry, 68(12), 1238-1246.

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[[Page 17642]]

    Adverse consequences associated with prescription drug misuse have 
also increased. Prescription drugs, especially opioid analgesics, have 
increasingly been implicated in drug overdose deaths over the last 
decade.\23\ The National Vital Statistics System indicated there were 
18,893 opioid analgesics overdose related deaths in 2014, which is 
nearly 5 times greater than the number of related deaths in 1999.\24\ 
Deaths related to heroin have also sharply increased, more than 
tripling between 2010 and 2014.\25\ Rates of prescription drug misuse 
related to emergency department visits and treatment admissions have 
risen significantly in recent years.\26\ The Centers for Disease 
Control and Prevention reports that almost 7,000 people are treated in 
emergency departments each day for using opioids in a manner other than 
as directed.\27\ Opioids, primarily prescription pain relievers and 
heroin, are the main drugs associated with overdose deaths. In 2014, 
opioids were involved in 28,647 deaths, or 61 percent of all drug 
overdose deaths; the rate of opioid overdoses has tripled since 
2000.\28\
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    \23\ Macrae, J. (2015, July 27). HHS Launches Multi-pronged 
Effort to Combat Opioid Abuse. Retrieved from: http://www.hhs.gov/blog/2015/07/27/hhs-launches-multi-pronged-effort-combat-opioid-abuse.html. Centers for Disease Control and Prevention. Wide-ranging 
Online Data for Epidemiologic Research (WONDER), Multiple-Cause-of-
Death file, 2000-2014. 2015.
    \24\ CDC/NCHS, National Vital Statistics System, Mortality File. 
Retrieved from: http://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf.
    \25\ HHS takes strong steps to address opioid-drug related 
overdose, death and dependence. (2015, March 26) Retrieved from: 
http://www.hhs.gov/about/news/2015/03/26/hhs-takes-strong-steps-to-address-opioid-drug-related-overdose-death-and-dependence.html.
    \26\ Substance Abuse and Mental Health Services Administration, 
supra note 18.
    \27\ Centers for Disease Control and Prevention. Wide-ranging 
Online Data for Epidemiologic Research (WONDER), Multiple-Cause-of-
Death file, (2015, October 28). Understanding the epidemic: When the 
prescription becomes the problem. Retrieved from: http://www.cdc.gov/drugoverdose/epidemic/.
    \28\ Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in 
Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb 
Mortal Wkly Rep. 2016;64(50):1378-82. Retrieved from: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm.
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    The economic costs of illegal drug use, including the use of 
medications that are prescribed for others, are considerable. According 
to the Office of National Drug Control Policy, the economic cost of 
drug addiction in the United States was estimated at $193 billion in 
2007, the last available estimate.\29\ Indeed, opioid use disorders 
contribute to over $72 billion in medical costs alone each year.\30\ 
These costs--costs related to treatment and prevention services; other 
health care costs, such as those for individuals with co-occurring 
illnesses that result from or are exacerbated by use and misuse of 
drugs obtained illicitly; and costs associated with lost productivity, 
social welfare, and crime--impose burdens on the workplace, healthcare 
system, and communities.
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    \29\ Study Shows Illicit Drug Use Costs U.S. Economy More Than 
$193 Billion. (2011, June 1). Retrieved from: https://www.whitehouse.gov/sites/default/files/ondcp/newsletters/ondcp_update_june_2011.pdf.
    \30\ Coalition Against Insurance Fraud. (2007). Prescription for 
peril: how insurance fraud finances theft and abuse of addictive 
prescription drugs. Retrieved from: http://www.insurancefraud.org/downloads/drugDiversion.pdf.
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B. Medication-Assisted Treatment (MAT)

    Opioid use disorder is a treatable medical condition from which it 
is possible to recover.\31\ Medication, along with other behavioral 
therapy, has the potential to play an important role in the successful 
treatment of opioid use disorder and provide a foundation for 
recovery.\32\ Research indicates that medication combined with 
behavioral health services produces the best outcomes.33 34 
Effective treatment is comprehensive and tailored to each patient's 
drug use patterns; medical and psychiatric co-morbidities, and social 
corollaries of substance use disorder; and includes consideration of 
the person's vocational and legal needs.\35\
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    \31\ Bart, G. (2012). Maintenance Medication for Opiate 
Addiction: The Foundation of Recovery. Journal of Addictive 
Diseases, 31(3), 207-225. http://doi.org/10.1080/10550887.2012.694598.
    \32\ Medication and Counseling Treatment. (2015, September 28). 
Retrieved from: http://www.samhsa.gov/medication-assisted-treatment/treatment.
    \33\ National Institute on Drug Abuse, supra note 2.
    \34\ Buprenorphine. (2015, September 25). Retrieved from: http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine.
    \35\ National Institute on Drug Abuse, supra note 2.
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    MAT is the use of medication in combination with behavioral health 
services to provide a whole-patient, individualized approach to the 
treatment of substance use disorder, including opioid use disorder.\36\ 
MAT is a safe and effective strategy for decreasing the frequency and 
quantity of opioid use and reducing the risk of overdose and death.\37\ 
Although MAT has significant evidence to support it as an effective 
treatment, it remains highly underutilized, with only an estimated 1 
million out of an estimated 2.5 million who needed treatment actually 
receiving it in 2012 \38\ This gap is a function of many factors, 
including treatment capacity and negative attitudes, prejudice, and 
discrimination that prevent individuals from seeking services. A full 
discussion of the barriers to MAT utilization can be found in the 
regulatory impact analysis of this document.
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    \36\ Medication and Counseling Treatment, supra note 32.
    \37\ Kresina, T.F., & Lubran, R.L. (2011). Improving public 
health through access to and utilization of medication assisted 
treatment. International Journal of Environmental Research and 
Public Health, 8(10):4102-17.
    \38\ Volkow, N.D., Frieden, T.R., Hyde, P.S., & Cha, S.S. 
(2014). Medication-assisted therapies--tackling the opioid-overdose 
epidemic. New England Journal of Medicine, 370(22):2063-6.
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    Methadone, buprenorphine, and naltrexone are the three main types 
of active ingredients \39\ contained in FDA approved products currently 
used to treat opioid use disorder in the U.S.\40\ Treatment of opioid 
use disorder using methadone can only be provided in OTPs regulated by 
SAMHSA under 42 CFR part 8 and requires patient assessments, on-site 
counseling, daily monitoring and observation of the medication use, and 
careful control of any take-home methadone.41 42 Also, 
methadone for opioid use disorder can only be dispensed in an OTP 
clinic setting.\34\ Unlike methadone, medicines containing 
buprenorphine are permitted to be dispensed in either an office-based 
setting or in an OTP, significantly increasing treatment access.\43\ 
Under 21 U.S.C. 823(g)(2), qualified practitioners can prescribe, 
administer, or dispense medicines containing buprenorphine for 
treatment of opioid use disorder in various settings, including in an 
office, community hospital, health department, or correctional 
facility. As with all medications used in MAT, buprenorphine is 
prescribed as part of a comprehensive treatment plan that includes 
counseling and participation in social support programs.\44\
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    \39\ Naloxone is an active ingredient in some forms of 
buprenorphine when used by other than the recommended sublingual 
(under the tongue) route.
    \40\ Volkow, supra note 38.
    \41\ Id.
    \42\ Methadone. (2015, September 28). Retrieved from: http://www.samhsa.gov/medication-assisted-treatment/treatment/methadone.
    \43\ Kresina, supra note 37.
    \44\ Id.
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C. Statutory and Rulemaking History

    There is a long history of laws and rules to protect people from 
unnecessary or inappropriate exposure to opioids. Two important laws 
are the CSA and the Controlled Substances Import and Export Act, which 
became law in 1970. Together, these statutes and their implementing 
regulations

[[Page 17643]]

govern the manufacturing and distribution of controlled substances. 
Controlled substances are those medications or chemical substances that 
are scheduled I through V under the CSA, with Schedule I having the 
most relative abuse potential and likelihood of causing dependence when 
abused, and Schedule V having the least potential for abuse and 
dependence.\45\
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    \45\ Controlled Substance Schedules. (2015). Retrieved from: 
http://www.deadiversion.usdoj.gov/schedules/.
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    In 2000, Congress amended the CSA (21 U.S.C. 801 et seq.) to 
establish ``waiver authority for physicians who dispense or prescribe 
certain narcotic drugs for maintenance treatment or detoxification 
treatment'' (Drug Addiction Treatment Act of 2000, Pub. L. 106-310, 
Title XXXV, 114 Stat. 1222, codified at 21 U.S.C. 823(g)(2)). This 
waiver authority established the existing 30 and 100 patient limits. 
Pursuant to such waiver authority, the statutory and regulatory 
requirement (21 U.S.C. 823(g)(1) and 21 CFR 1301.13(e)) that a 
practitioner obtain a separate DEA registration to prescribe 
buprenorphine for maintenance or detoxification treatment is waived. 
Prior to this amendment, practitioners who wanted to provide 
maintenance or detoxification treatment using opioid drugs were 
required to be registered as Narcotic Treatment Programs, today 
commonly referred to as OTPs.
    Under the provisions of the CSA implementing regulations (21 CFR 
1301.28(b)(1)(iii) and (iv)), the 30-patient limitation applied equally 
to individual practices and to group practices (i.e., 30 patients per 
group practice), severely limiting the number of patients who could be 
treated by physicians in group practices. In 2005, the CSA was amended 
to lift the patient limitation on prescribing opioid addiction 
treatment medications by practitioners in group practices (Pub. L. 109-
56) so that practitioners could prescribe up to 30 patients 
individually regardless of whether they are in a group or solo 
practice.\46\ In 2006, the CSA was further amended by the Office of 
National Drug Control Policy Reauthorization Act of 2006 (Pub. L. 109-
469) to permit the treatment of up to 100 patients by each qualifying 
practitioner. As a result, DEA made conforming changes their 
regulations.\47\
---------------------------------------------------------------------------

    \46\ ``A bill to amend the Controlled Substances Act to lift the 
patient limitation on prescribing drug addiction treatments by 
medical practitioners in group practices, and for other purposes'' 
(Pub. L. 109-56).
    \47\ See 21 CFR 1301.28(b)(1)(iii) and (iv).
---------------------------------------------------------------------------

D. Current Process for Obtaining a Practitioner Waiver Under 21 U.S.C. 
823(g)(2)

    To be able to prescribe buprenorphine for the maintenance or 
detoxification of opioid use disorder, qualified practitioners must 
file a Request for Patient Limit Increase with SAMHSA. In accordance 
with 21 U.S.C. 823(g)(2)(D)(iii), SAMHSA processes the Request for 
Patient Limit Increase by verifying the practitioner's medical license 
and qualification to prescribe buprenorphine, and informs the DEA of 
whether the practitioner meets all of the statutory requirements for a 
waiver. If the statutory requirements for a waiver are met, the DEA 
verifies the practitioner's current registration and assigns an 
identification number to the practitioner. This information is conveyed 
to the practitioner by a letter issued from SAMHSA. At this point, the 
practitioner is considered to be a waivered practitioner.
    Waivered practitioners must comply with all sections of the CSA 
regarding validity of prescriptions, recordkeeping, inventory, and 
medication administration or dispensing. DEA is authorized to conduct 
periodic on-site inspections of all registrants. As of 2013, DEA had 
systematically visited nearly all waivered practitioners. Most 
inspections were uneventful, and the majority of practitioners were 
found to be in compliance. Problems encountered typically involved 
administrative issues and required practitioners to make changes to 
recordkeeping practices. Should DEA find violations of law, it can 
revoke a practitioner's right to prescribe buprenorphine and take 
further legal action, if necessary.

E. Evaluations of the Current System

    Evaluations of the process for granting waivers under the 21 U.S.C. 
823(g)(2) waiver system are limited. In 2006, SAMHSA published the 
results of an evaluation that examined the availability and 
effectiveness of treatment as well as adverse consequences.\48\
---------------------------------------------------------------------------

    \48\ Substance Abuse and Mental Health Services Administration. 
(2006). The SAMHSA Evaluation of the Impact of the DATA Waiver 
Program. Retrieved from: http://www.buprenorphine.samhsa.gov/FOR_FINAL_summaryreport_colorized.pdf.
---------------------------------------------------------------------------

    A number of barriers to MAT adoption using buprenorphine in an 
office-based setting were identified in this evaluation, with three in 
particular that were consistently identified amongst waivered 
practitioners as problematic: (1) The 30-patient limit, (2) limited 
third-party reimbursement, and (3) high medication/treatment costs. 
Additional barriers identified include a hesitation to initiate 
buprenorphine prescribing because of (1) a lack of a sufficient number 
of patients needing MAT for opioid use disorders, (2) difficult initial 
treatment setup and logistics, and (3) patients' reluctance around 
counseling as a component of treatment. A number of non-waivered 
practitioners cited common challenges to obtaining a waiver, including 
lack of appropriate training or experience, concerns about 
recordkeeping and potential audits by DEA, and a scarcity of 
appropriate concomitant counseling resources in their areas.
    More recently, in September 2014, SAMHSA, in partnership with the 
National Institute on Drug Abuse, convened a meeting of expert 
professionals for a Buprenorphine Summit to gather the perspectives of 
leaders from the field regarding the state of practice and their 
assessment of possible strategies for moving forward. This Summit 
presented an opportunity for active and collaborative discussion about 
caring for patients; designing, operating, and sustaining programs; 
supporting recovery; and training practitioners. The participants 
explored what is known about the adoption of MAT with buprenorphine-
containing products to treat opioid use disorder; reasons why it has 
not been as widely prescribed as might have been expected; and ways 
that Federal agencies, health professionals, and concerned individuals 
might enable buprenorphine treatment to become more accessible.
    Participants from the Summit provided some reasons waivered 
practitioners were not prescribing buprenorphine, including but not 
limited to the following: Practitioners do not have practice partners 
with waivers or practice partners who can provide cross-coverage 
because of the interpretation of the patient limit; they lack 
institutional support; their community lacks psychosocial resources for 
patients; they feel that with current patient limits, they cannot treat 
a sufficient volume of patients to meet all of the costs of providing 
buprenorphine given current third-party reimbursement; the regulations 
and scrutiny particular to prescribing buprenorphine can make them feel 
as if they are doing something questionable by prescribing it; and 
current confidentiality rules make it difficult to integrate substance 
use disorder care with primary care.
    Some of the ideas that came out of the Summit included strategies 
to expand availability of buprenorphine treatment for opioid use 
disorders, such as

[[Page 17644]]

examining the elimination of restrictions on prescribing buprenorphine. 
Specific ideas included enabling non-physician practitioners to 
prescribe buprenorphine (which would require a legislative change); 
raising the cap on how many patients a practitioner can have in 
treatment at a time; and allowing practitioners to cross-cover one 
another on a short-term basis, which is a practice standard across 
medicine, without being in violation of the patient limit. The latter 
two are addressed in this Notice of Proposed Rulemaking (NPRM).

F. Need for Rulemaking

    In the intervening 15 years since enactment of 21 U.S.C. 823(g)(2), 
there have been a number of changes, including the amendment that (1) 
allowed for practitioners in group practices to prescribe up to 30 
patients individually regardless of whether they are in a group or sole 
practice, and (2) allowed for practitioners who had a waiver for at 
least 1 year to submit a second NOI to treat up to 100 patients at a 
time. Other changes include expansion in insurance coverage and parity 
protections due to passage of the Mental Health Parity and Addiction 
Equity Act, as well as the Affordable Care Act. Educational and 
training activities have also expanded, including the FDA Risk 
Evaluation and Mitigation Strategy (REMS) for buprenorphine and 
SAMHSA's Provider Clinical Support System for MAT. In addition, a new 
subspecialty board certification has been developed for allopathic 
physicians in addiction medicine, creating a pathway for more 
physicians to obtain broader knowledge of substance use disorders in 
general.
    Despite this progress, the nation finds itself in the midst of a 
public health crisis of opioid addiction, misuse, and related morbidity 
and mortality.\49\ Each day in the United States, 44 people die from 
overdose of prescription pain relievers.\50\ As previously stated, in 
2014, opioids were involved in 28,647 deaths, or 61 percent of all drug 
overdose deaths; the rate of opioid overdoses has tripled since 
2000.\51\
---------------------------------------------------------------------------

    \49\ FACT SHEET: Obama Administration Announces Public and 
Private Sector Efforts to Address Prescription Drug Abuse and Heroin 
Use. (2015, October 21). Retrieved from: https://www.whitehouse.gov/the-press-office/2015/10/21/fact-sheet-obama-administration-announces-public-and-private-sector.
    \50\ Centers for Disease Control and Prevention, supra note 27.
    \51\ Rudd, supra note 28.
---------------------------------------------------------------------------

    There are approximately 1,400 OTPs and 31,857 practitioners waived 
to prescribe buprenorphine. The use of extended-release injectable 
naltrexone has also made an important contribution to increasing access 
to MAT in the private physician office-based setting, but the number of 
patients receiving treatment with naltrexone in such settings is not 
known. Providers wishing to serve more people have the option of both 
office-based MAT with buprenorphine products as well as specialty 
addiction treatment programs that include an OTP. However, recent 
research has also shown that an estimated 1 million people out of 2.3 
million individuals in the U.S. with opioid abuse or dependence were 
untreated.\52\ This assumes that practitioners were treating patients 
at maximum capacity. Data from DATA-waived providers in 2008 \53\ 
indicate that practitioners are likely only reaching 57 percent of 
their total patient capacity for buprenorphine treatment. At the State 
level, an estimated 3 patients per 1,000 people in the U.S. had an 
unmet need for treatment, assuming that practitioners were treating 
patients at maximum potential capacity.\54\
---------------------------------------------------------------------------

    \52\ Jones CM, Campopiano M, Baldwin G, McCance-Katz E. National 
and state treatment need and capacity for opioid agonist medication-
assisted treatment. Am J Public Health 2015;105(8):e55-e63.
    \53\ Arfken CL, Johanson CE, Menza SD, Schuster CR. Expanding 
treatment capacity for opioid ependence with office-based treatment 
with buprenorphine: national surveys of physicians. J Subst Abuse 
Treat. 2010;39(2):96-104.
    \54\ Jones, supra note 53.
---------------------------------------------------------------------------

    While the Federal Guidelines for OTPs, published early in 2015, 
promote the use of both buprenorphine and naltrexone, in addition to 
methadone, in the approximately 1,400 OTPs, increasing access to MAT 
through OTPs is limited by several factors. These factors include the 
fact that the patient capacity of individual OTPs is typically 
determined by State licensing requirements, building permits, or other 
State or local regulations. Geography and the daily nature of methadone 
treatment are other factors that affect the ability to expand access to 
MAT via OTPs in general, but they do not directly relate to the 
capacity of an individual OTP to treat patients. Rather they are 
limitations on the expansion of access to more individuals utilizing 
methadone specifically.
    HHS is promoting access to all forms of MAT for opioid use disorder 
through multiple activities included in the Secretary's Opioid 
Initiative. Given the Secretary's unique authority to increase the 
patient limit on treatment under 21 U.S.C. 823(g)(2) by rulemaking, the 
proposed rule is an essential element of a comprehensive approach to 
increasing access to MAT.
    Increasing the limits on the number of patients per waivered 
practitioner has been requested by many individuals, organizations, and 
entities. In a letter to the Secretary, ASAM notes that the prescribing 
limit is a major barrier to patient access to care and the current 
limits place arbitrary limits on the number of patients a practitioner 
can treat. It also notes that no other medications are limited in such 
a manner.\55\ The American Psychiatric Association, American Academy of 
Addiction Psychiatry, and the American Osteopathic Academy of Addiction 
Medicine also wrote to the Secretary and stated that as ``the number of 
people addicted to these opioids increases, there continues to be a 
shortage of physicians who are appropriately trained to treat them. The 
shortage severely complicates and impairs our ability to effectively 
address the epidemic, particularly in many rural and underserved areas 
of the nation.'' \56\
---------------------------------------------------------------------------

    \55\ Letter to Secretary Burwell from the American Society for 
Addiction Medicine, July 31, 2014.
    \56\ Letter to Secretary Burwell from the American Psychiatric 
Association, American Academy of Addiction Psychiatry, and the 
American Osteopathic Academy of Addiction Medicine, July 25, 2014.
---------------------------------------------------------------------------

    In sum, given the public health crisis of opioid misuse and abuse 
and the treatment gap between those individuals with an opioid use 
disorder and those currently receiving treatment, this proposed rule is 
needed to raise the patient cap in an effort to increase access to MAT 
with buprenorphine and associated counseling and supports. In keeping 
with the spirit of mental health parity, we emphasize that competency 
in addiction care should exist throughout the healthcare continuum. To 
balance optimal access and safety, we strive to ensure that the 
credentials needed to prescribe MAT are within reach for interested 
physicians, programs are practical to implement, and reporting 
requirements are not perceived as a barrier to participation. We seek 
comment on whether the proposed rule appropriately strikes this 
balance.

IV. Summary of Proposed Rule

A. General

    To date, SAMHSA has implemented the provisions of 21 U.S.C. 
823(g)(2) without rulemaking due to the clear and specific provisions 
included in the statute. As authorized by the statute at 21 U.S.C. 
823(g)(2)(B)(iii), SAMHSA is initiating rulemaking at this time to 
increase access to MAT with

[[Page 17645]]

buprenorphine in the office-based setting as authorized under 21 U.S.C. 
823(g)(2). The proposed rule would increase the highest available 
patient limit for qualified practitioners to receive a waiver from 100 
to 200. This new higher patient limit would significantly increase 
patient capacity for practitioners qualified to prescribe at this level 
while also ensuring that waivered practitioners would be able to 
provide the full treatment continuum associated with MAT.
    Practitioners authorized to treat up to 200 patients under 21 
U.S.C. 823(g)(2) would be required to meet infrastructure, capacity, 
and reporting requirements that exceed those required for the lower 
limits. The incremental increase from 100 to 200 patients and the 
concomitant reporting requirements would allow the Department to 
monitor the quality of care being delivered, identify any changes in 
the rate of diversion, and improvements in health outcomes for opioid-
dependent patients. It would attach additional criteria and 
responsibilities to practitioners who would be able to treat up to 200 
patients with the specific aims of ensuring quality of care and 
minimizing diversion. Importantly, the additional criteria and 
responsibilities are not intended to be unduly burdensome to the 
practitioner who wishes to expand his or her MAT treatment practice and 
we seek comment on the associated burden. Rather, they are intended to 
reflect the current standard of care for the treatment of opioid use 
disorder while also recognizing the growing demand for opioid use 
disorder treatment integrated into the non-specialist practice in more 
mainstream settings. This proposed rule does not add these additional 
requirements to practitioners who have a waiver to treat 100 or fewer 
patients under 21 U.S.C. 823(g)(2). The proposed rule also would create 
an option for an increased patient limit for practitioners responding 
to emergency situations that require immediate, increased access to MAT 
pharmacotherapies. Also included in the proposed rule are key 
definitions.
    This proposal would add subpart F to 42 CFR part 8. To accomplish 
this, additional changes would be made to part 8. Proposed changes to 
part 8 to accommodate the proposed rule include retitling the part to 
encompass all MAT over which the Secretary has regulatory authority. 
Consequently, under the proposed rule, subpart A would be entitled 
General Provisions. Current subparts A, B, and C would change to 
subparts B, C, and D, respectively. The titles of these subparts would 
be revised to make it clear that they apply only to OTPs.

B. Scope (Sec.  8.1)

    Under the proposed rule, the scope of part 8 would encompass rules 
that are applicable to OTPs, and to waivered practitioners who seek to 
provide MAT to more than 100 patients. New subparts B through D under 
the proposed rule would contain the rules relevant to OTPs. Subpart E 
would be reserved and Subpart F would contain the proposed new rule. 
Section 8.1 would also explain that the proposed rules in the new 
subpart F pertain only to those practitioners using a waiver under 21 
U.S.C. 823(g)(2) with a patient limit of 101 to 200.

C. Definitions (Sec.  8.2)

    The definitions section would apply to the entirety of part 8. 
Definitions that would apply only to OTPs would be revised to reflect 
this in the specific definition. Two definitions would be eliminated: 
``Registered opioid treatment program'' would be deleted because the 
term is not used anywhere in the text of the regulations; and the 
definition for ``opiate addiction'' would be renamed ``opioid use 
disorder.''
    This proposed rule also includes a definition of ``patient.'' At 
present, the definition of ``patient'' in Sec.  8.2 is limited to those 
individuals receiving treatment at an OTP, which excludes those 
individuals receiving office-based opioid treatment with buprenorphine, 
i.e., those subject to 21 U.S.C. 823(g)(2). As a result, there has been 
confusion among providers, insurers, pharmacists, and diversion 
investigators. This stems in part from the difference between formal 
admission and discharge practices that are customarily used in OTPs and 
other substance use disorder treatment programs and the more open-ended 
relationship between patient and practitioner in general medical and 
psychiatric practice. This confusion has also complicated the data 
collection necessary to assess access to treatment on community, state, 
and national levels. It has also hindered cross-coverage due to a 
concern that covering a patient for a short period of time keeps a 
practitioner accountable for that patient for an extended period of 
time.
    The proposed rule would revise the definition of patient to make it 
inclusive of all persons receiving MAT with an opioid medication, 
consistent with the expanded scope of proposed revisions to 42 CFR part 
8. By proposing that patient ``means any individual who receives MAT 
from a practitioner or program subject to this part,'' the definition 
would apply to the entire period during which the eligible medication 
is expected to be used by the patient while under that practitioner's 
care. For example, if a practitioner provides cross-coverage for 
another practitioner, and in the course of that coverage the covering 
practitioner provides a prescription for buprenorphine, the patient 
counts towards the cross-covering practitioner's patient limit until 
the prescription has expired. However, if a cross-covering practitioner 
is merely available for consult but does not provide a prescription for 
buprenorphine while the prescribing practitioner is away, the patients 
being covered do not count towards the cross-covering practitioner's 
patient limit at all. Therefore, this definition would be expected to 
help ensure consistency and clarity in how waivered practitioners count 
patients towards the limit. We seek comments on this definition and 
other examples of coverage arrangements where clarity would be helpful.
    The proposed rule would include the following definition of patient 
limit: ``the maximum number of individual patients a practitioner may 
treat at any time using covered medications.''
    Taken together, these two definitions would provide clear and fair 
guidance for regulatory enforcement and would be expected to reduce 
undercounting of patients by practitioners and, furthermore, would 
exclude those patients with whom a practitioner interacts as a 
professional courtesy or in a transitory fashion on behalf of another 
waivered physician from being counted against the covering 
practitioner's patient limit for an extended period of time. In this 
way it is expected that waivered practitioners will be able to provide 
reciprocal cross-coverage of patients for brief periods, such as 
weekends or vacations, without implications, long-term or possibly at 
all, for their respective individual limits.
    Other new definitions would include ``behavioral health services,'' 
``nationally recognized evidence-based guidelines'' and ``emergency 
situation.'' These definitions would be in-line with definitions 
offered elsewhere and applied in the field. They would be minimally 
modified from other existing definitions to clarify the application of 
these terms to the unique circumstances of the practitioner providing 
MAT under 21 U.S.C. 823(g)(2).
    In addition, this proposed rule would define ``nationally 
recognized evidence-based guidelines'' to mean a document produced by a 
national or international medical professional association, public 
health entity, or governmental body

[[Page 17646]]

with the aim of ensuring the appropriate use of evidence to guide 
individual diagnostic and therapeutic clinical decisions. Some examples 
include the ASAM National Practice Guidelines for the Use of 
Medications in the Treatment of Addiction Involving Opioid Use; 
SAMHSA's Treatment Improvement Protocol 40: Clinical Guidelines for the 
Use of Buprenorphine in the Treatment of Opioid Addiction; the World 
Health Organization Guidelines for the Psychosocially Assisted 
Pharmacological Treatment of Opioid Dependence; and the Federation of 
State Medical Boards' Model Policy on DATA 2000 and Treatment of Opioid 
Addiction in the Medical Office. SAMHSA would expect that guidelines 
falling into this definition may change over time but would not plan to 
keep a list for practitioners to consult.

D. Opioid Treatment Programs (Sec. Sec.  8.3 Through 8.34)

    Proposed retitled subparts B, C, and D would contain Sec. Sec.  8.3 
through 8.34. Proposed changes to these sections would be limited to 
changing the mailing address for program certification and 
accreditation body approval and updating terms, such as ``opiate'' and 
``opiate addiction'' to ``opioid'' and ``opioid use disorder,'' 
respectively.

E. Which Practitioners Are Eligible for a Patient Limit of 200? (Sec.  
8.610)

    This is the first proposed section of the new subpart F. Proposed 
Sec.  8.610 would describe which practitioners are eligible for a 
patient limit of 200. Under routine conditions, a practitioner would 
qualify for the higher limit in one of two ways: By possessing 
subspecialty board certification in addiction medicine or addiction 
psychiatry or by practicing in a qualified practice setting as defined 
in the rule. In either case, practitioners with the higher limit would 
have to possess a waiver to treat 100 patients for at least 1 year in 
order to gain experience treating at a higher limit. The purpose of 
offering the 200 patient limit to practitioners in these two categories 
is to recognize the benefit offered to patients through: (1) The 
advanced training and maintenance of knowledge and skill associated 
with the acquisition of subspecialty board certification; and (2) the 
higher level of direct service provision and care coordination 
envisioned in the qualified practice setting. This approach would 
restrict access to the 200 patient limit to a subset of the 
practitioners waivered to provide care to up to 100 patients. In 
addition to ensuring higher quality of care, the criteria for the 
higher limit would be intended to minimize the risk of diversion of 
controlled substances to illicit use and accidental exposure that could 
result from increased prescribing of buprenorphine. A practitioner with 
board certification in an addiction subspecialty would have to have the 
training and experience necessary to recognize and address behaviors 
associated with increased risk of diversion. In the qualified practice 
settings, SAMHSA believes that the care team and practice systems will 
function to help ensure this same level of care. We seek comments on 
this proposed approach, including comments on whether there are other 
ways for SAMHSA to ensure quality and safety while encouraging 
practitioners to take on additional patients.

F. What Constitutes a Qualified Practice Setting? (Sec.  8.615)

    Proposed Sec.  8.615 would describe the necessary elements of a 
qualified practice setting, which can include practices with as few as 
one waived provider as long as these criteria are met and can include 
both private practices and community-based clinics. Necessary elements 
of a qualified practice setting would include having: (1) The ability 
to offer patients professional coverage for medical emergencies during 
hours when the practitioner's practice is closed; this does not need to 
involve another waivered practitioner, only that coverage be available 
for patients experiencing an emergency even when the office is closed; 
(3) the ability to ensure access to patient case-management services; 
(4) health information technology (HIT) systems such as electronic 
health records, when practitioners are required to use it in the 
practice setting in which he or she practices; (5) participation in a 
prescription drug monitoring program (PDMP), where operational, and in 
accordance with State law. PDMP means a statewide electronic database 
that collects designated data on substances dispensed in the State. For 
practitioners providing care in their capacity as employees or 
contractors of a Federal government agency, participation in a PDMP 
would be required only when such participation is not restricted based 
on State law or regulation based on their state of licensure and is in 
accordance with Federal statutes and regulations; and (6) employment, 
or a contractual obligation to treat patients in a setting that has the 
ability to accept third-party payment for costs in providing health 
services, including written billing, credit and collection policies and 
procedures, or Federal health benefits.
    The elements were identified as common to many high-quality 
practice settings, which includes both private practices as well as 
federally qualified health centers and community mental health centers, 
and therefore worthy of replication. The elements would be expected to 
be common to OTPs, and OTPs currently in operation but not providing 
MAT under 21 U.S.C. 823(g)(2). Taken together, this would facilitate 
additional opportunities to expand access to MAT. Another consideration 
in the selection of these elements would be the need to limit the 
expansion of group practices formed for the sole purpose of pooling the 
individual practitioner limits to maximize revenue but which fail to 
offer a full continuum of services. HHS seeks comment on additional, 
alternate pathways by which a practitioner may become eligible to apply 
for a patient waiver of 200.

G. What is the process to request a patient limit of 200? (Sec.  8.620)

    Proposed Sec.  8.620 would describe the process to request a 
patient limit of 200. Similar to the waiver process for the 30 and 100 
patient limits, the process would begin with filing a Request for 
Patient Limit Increase. A proposed draft of the Request for Patient 
Limit Increase is in the docket. Public comment is requested. The 
higher patient limit would carry with it greater responsibility for 
behavioral health services, care coordination, diversion control, and 
continuity of care in emergencies and for transfer of care in the event 
approval to treat up to 200 patients is not renewed or is denied. The 
new Request for Patient Limit Increase process would require providers 
to affirm that they would meet these requirements. The proposed 
definitions of ``behavioral health services,'' ``diversion control 
plan,'' ``emergency situation,'' ``nationally recognized evidence-based 
guidelines'' and ``practitioner incapacity'' would be provided in Sec.  
8.2 to assist practitioners in understanding what is expected of them 
in making these attestations. These responsibilities would be aligned 
with the standards of ethical medical and business practice and would 
not be expected to be burdensome to practitioners. Resources exist to 
help in the development in patient placement in the event transfer to 
other addiction treatment would be required, for example, if a provider 
chose to no longer practice at the 200 patient limit. Examples of these 
resources would include but are not limited to: Single

[[Page 17647]]

State Authorities and State Opioid Treatment Authorities. Practitioners 
approved to treat up to 200 patients would also be required to reaffirm 
their ongoing eligibility to fulfill these requirements every 3 years 
as described in Sec.  8.640.

H. How will a request for patient limit increase be processed? (Sec.  
8.625)

    Proposed Sec.  8.625 would describe how SAMHSA will process a 
Request for Patient Limit increase. The process for requesting a 
patient limit up to 200 would be processed similarly to how the current 
30 or 100 patient waiver is processed, with one difference. Whereas the 
lower patient limit waivers are not time limited, the waiver for the 
higher limit of 200 would have a term not to exceed 3 years. Thus, a 
practitioner would be required to submit a new Request for Patient 
Limit Increase every 3 years if he or she desired to continue treating 
up to 200 patients.

I. What must practitioners do in order to maintain their approval to 
treat up to 200 patients under Sec.  8.625? (Sec.  8.630)

    Proposed Sec.  8.630 would describe the conditions for maintaining 
a waiver for each 3-year period for which waivers are valid, including 
maintenance of all eligibility requirements specified in Sec.  8.610, 
and all attestations made in accordance with Sec.  8.620(b). Compliance 
with the requirements specified in Sec.  8.620 would have to be 
continuous. This includes compliance with reporting requirements 
specified in Sec.  8.635.

J. What are the reporting requirements for practitioners whose request 
for patient limit increase is approved under Sec.  8.625? (Sec.  8.635)

    Proposed Sec.  8.635 would describe the reporting requirements for 
practitioners whose Request for Patient Limit Increase is approved 
under Sec.  8.625. Reporting would be required annually to ensure that 
eligibility requirements are being maintained and that waiver 
conditions are being fulfilled. We seek comments on whether the 
proposed reporting periods and deadline could be combined with other, 
existing reporting requirements in a way that would make reporting less 
burdensome for practitioners. Reporting requirements may include a 
request for information regarding:
a. The average monthly caseload of patients receiving buprenorphine-
based MAT, per year
b. Percentage of active buprenorphine patients (patients in treatment 
as of reporting date) that received psychosocial or case management 
services (either by direct provision or by referral) in the past year 
due to:
    1. Treatment initiation
    2. Change in clinical status
c. Percentage of patients who had a prescription drug monitoring 
program query in the past month
d. Number of patients at the end of the reporting year who:
    1. Have completed an appropriate course of treatment with 
buprenorphine in order for the patient to achieve and sustain recovery
    2. Are not being seen by the provider due to referral by the 
provider to a more or less intensive level of care
    3. No longer desire to continue use of buprenorphine
    4. Are no longer receiving buprenorphine for reasons other than 1-
3.
We seek comment on this list.

K. What is the process for renewing a practitioner's request for 
patient limit increase approval? (Sec.  8.640)

    Proposed Sec.  8.640 would describe the process for a practitioner 
renewing his or her approval for the higher patient limit. In order for 
a practitioner to renew an approval, he or she would have to submit a 
renewal Request for Patient Limit Increase in accordance with the 
procedures outlined under Sec.  8.620 at least 90 days before the 
expiration of the approval term.

L. What are the responsibilities of practitioners who do not submit a 
renewal request for patient limit increase or whose request is denied? 
(Sec.  8.645)

    Proposed Sec.  8.645 would describe the responsibilities of 
practitioners who do not submit a renewal Request for Patient Limit 
Increase or whose request is denied. Under Sec.  8.620(b)(7) 
practitioners would notify all patients affected above the 100 patient 
limit, that the practitioner would no longer be able to provide MAT 
services using covered medications and would make every effort to 
transfer patients to other addiction treatment.

M. Can SAMHSA suspend or revoke a practitioner's patient limit increase 
approval? (Sec.  8.650)

    Proposed Sec.  8.650 would describe under what circumstances SAMHSA 
would suspend or revoke a practitioner's patient limit increase of 200. 
If SAMHSA had reason to believe that immediate action would be 
necessary to protect public health or safety, SAMHSA would suspend the 
practitioner's patient limit increase of 200. If SAMHSA determined that 
the practitioner had made misrepresentations in his or her Request for 
Patient Limit Increase, or if the practitioner no longer satisfied the 
requirements of this subpart, or he or she has been found to have 
violated the CSA pursuant to 21 U.S.C. 824(a), SAMHSA would revoke the 
practitioner's patient limit increase of 200.

N. Can a practitioner request to temporarily treat up to 200 patients 
in emergency situations? (Sec.  8.655)

    Proposed Sec.  8.655 would describe the process, including the 
information and documentation necessary, for a practitioner with an 
approved 100 patient limit, to request approval to temporarily treat up 
to 200 patients in an emergency situation. The intention of this 
provision would be to help assure continuity of care for patients whose 
care might otherwise be abruptly terminated due to the death or 
disability of their practitioner. This provision would also help 
communities respond rapidly to a sudden increase in demand for 
medication assisted treatment. Sudden increases in demand for treatment 
may be experienced when there is a local disease outbreak associated 
with drug use, or when a natural or human-caused disaster either 
displaces persons in treatment from their practitioner or program or 
destroys program infrastructure. The emergency provision generally 
would not be intended to correct poor resource deployment due to lack 
of planning. The emergency provision of the proposed rule would only be 
considered if other options for addressing the increased demand for 
medication-assisted treatment could not address the situation.
    The practitioner must provide information and documentation that: 
(1) Describes the emergency situation in sufficient detail so as to 
allow a determination to be made regarding whether the emergency 
qualifies as an emergency situation as defined in Sec.  8.2, and that 
provides a justification for an immediate increase in that 
practitioner's patient limit; (2) Identifies a period of time in which 
the higher patient limit should apply, and provides a rationale for the 
period of time requested; and (3) Describes an explicit and feasible 
plan to meet the public and individual health needs of the impacted 
persons once the practitioner's approval to treat up to 200 patients 
expires. Prior to taking action on a practitioner's request under this 
section, SAMHSA shall consult, to the extent practicable, with the 
appropriate governmental authority in order to

[[Page 17648]]

determine whether the emergency situation that a practitioner describes 
justifies an immediate increase in the higher patient limit. If, after 
consultation with the governmental authority, SAMHSA determines that a 
practitioner's request under this section should be granted, SAMHSA 
will notify the practitioner that his or her request has been approved. 
The period of such approval shall not exceed six months. A practitioner 
wishing to receive an extension of the approval period granted must 
submit a request to SAMHSA at least 30 days before the expiration of 
the six month period and certify that the emergency situation 
continues. Except as provided in this section and Sec.  8.650, 
requirements in other sections under subpart F do not apply to 
practitioners receiving waivers in this section.

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), agencies are 
required to provide 60-day notice in the Federal Register and solicit 
public comment before a collection of information requirement is 
submitted to the Office of Management and Budget (OMB) for review and 
approval. Currently, the information collection associated with the 30-
patient and 100-patient limits is approved under OMB Control No. 0930-
0234. In order to fairly evaluate whether changes to an information 
collection should be approved by the OMB, section 3506(c)(2)(A) of the 
PRA requires that we solicit comment on the following issues:
    1. Whether the information collection is necessary and useful to 
carry out the proper functions of the agency;
    2. The accuracy of the agency's estimate of the information 
collection burden;
    3. The quality, utility, and clarity of the information to be 
collected; and
    4. Recommendations to minimize the information collection burden on 
the affected public, including automated collection techniques.
    Under the PRA, the time, effort, and financial resources necessary 
to meet the information collection requirements referenced in this 
section are to be considered in rulemaking. We explicitly seek, and 
will consider, public comment on our assumptions as they relate to the 
PRA requirements summarized in this section. This proposed rule 
includes changes to information collection requirements, that is, 
reporting, recordkeeping or third-party disclosure requirements, as 
defined under the PRA (5 CFR part 1320). Some of the provisions would 
involve changes from the information collections set out in the 
previous regulations.
    Information collection requirements would be:
    A. Approval, 42 CFR 8.620(a) through (c): In order for a 
practitioner to receive approval for a patient limit of 200, a 
practitioner must meet all of the requirements specified in Sec.  8.610 
and submit a Request for Patient Limit Increase to SAMHSA that includes 
all of the following:
     Completed 3-page Request for Patient Limit Increase Form, 
a draft of which is available for review in the public docket;
     Statement certifying that the practitioner:
    [cir] Will adhere to nationally recognized evidence-based 
guidelines for the treatment of patients with opioid use disorders;
    [cir] Will provide patients with necessary behavioral health 
services as defined in Sec.  8.2 or will provide such services through 
an established formal agreement with another entity to provide 
behavioral health services;
    [cir] Will provide appropriate releases of information, in 
accordance with Federal and State laws and regulations, including the 
Health Information Portability and Accountability Act Privacy Rule and 
part 2 of this chapter, if applicable, to permit the coordination of 
care with behavioral health, medical, and other service practitioners;
    [cir] Will use patient data to inform the improvement of outcomes;
    [cir] Will adhere to a diversion control plan to manage the covered 
medications and reduce the possibility of diversion of covered 
medications from legitimate treatment use;
    [cir] Has considered how to assure continuous access to care in the 
event of practitioner incapacity or an emergency situation that would 
impact a patient's access to care as defined in Sec.  8.2; and
    [cir] Will notify all patients above the 100 patient level, in the 
event that the request for the higher patient limit is not renewed or 
is denied, that the practitioner will no longer be able to provide MAT 
services using buprenorphine to them and make every effort to transfer 
patients to other addiction treatment;
    B. Diversion Control Plan, 42 CFR 8.12(c)(2): Creating and 
maintaining a diversion control plan is one of the requirements that 
practitioners must attest to before they are approved to treat at the 
higher limit. This plan is not required to be submitted to SAMHSA.
    C. Reporting, 42 CFR 8.635: Reporting will be required annually to 
ensure that eligibility requirements are being maintained and that 
waiver conditions are being fulfilled. Reporting requirements may 
include a request for information regarding: (1) The average monthly 
caseload of patients receiving buprenorphine-based MAT, per year; (2) 
the percentage of active buprenorphine patients (patients in treatment 
as of reporting date) who received psychosocial or case management 
services (either by direct provision or by referral) in the past year 
due to treatment initiation or change in clinical status; (3) 
Percentage of patients who had a prescription drug monitoring program 
query in the past month; (4) Number of patients at the end of the 
reporting year who: (a) Have completed an appropriate course of 
treatment with buprenorphine in order for the patient to achieve and 
sustain recovery, (b) Are not being seen by the provider due to 
referral by the provider to a more or less intensive level of care, (c) 
No longer desire to continue use of buprenorphine, (d) Are no longer 
receiving buprenorphine for reasons other than (a) through (c). To 
facilitate public comment, we have placed a draft version of the 
collection template in the public docket.
    D. Renewal, 42 CFR 8.640: Describes the process for a practitioner 
renewing his or her approval for the higher patient limit. In order for 
a practitioner to renew an approval, he or she must submit a renewal 
Request for Patient Limit Increase in accordance with the procedures 
outlined under Sec.  8.620 at least 90 days before the expiration of 
the approval term.
    E. Patient Notice, 42 CFR 8.645: Describes the responsibilities of 
practitioners who do not submit a renewal Request for Patient Limit 
Increase. Practitioners who do not renew their Request for Patient 
Limit Increase must notify all patients above the 100 patient limit 
that the practitioner will no longer be able to provide MAT services 
using covered medications and make every effort to transfer patients to 
other addiction treatment. The Patient Notice is a model notice to 
guide practitioners in this situation when they notify their patients.
    F. Emergency Provisions, 42 CFR 8.655: Describes the process for 
practitioners with a current waiver to prescribe up to 100 patients, 
and who are not otherwise eligible to treat up to 200 patients, to 
request a temporary increase to treat up to 200 patients in order to 
address emergency situations as defined in Sec.  8.2. To initiate this 
process, the practitioner shall provide information and documentation 
that: (1) Describes the emergency situation in

[[Page 17649]]

sufficient detail so as to allow a determination to be made regarding 
whether the situation qualifies as an emergency situation as defined in 
Sec.  8.2, and that provides a justification for an immediate increase 
in that practitioner's patient limit; (2) Identifies a period of time, 
not longer than 6 months, in which the higher patient limit should 
apply, and provides a rationale for the period of time requested; and 
(3) Describes an explicit and feasible plan to meet the public and 
individual health needs of the impacted persons once the practitioner's 
approval to treat up to 200 patients expires. If a practitioner wishes 
to receive an extension of the approval period granted under this 
section, he or she must submit a request to SAMHSA at least 30 days 
before the expiration of the 6-month period, and certify that the 
emergency situation as defined in Sec.  8.2 necessitating an increased 
patient limit continues.
    Annual burden estimates for these requirements are summarized in 
the following table:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Burden/       Total
              42 CFR Citation                    Purpose of submission       Number of    Responses/    response      burden    Hourly wage   Total wage
                                                                            respondents   respondent     (hour)       (hour)      cost ($)     cost ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.620(a) through (c).......................  Request for Patient Limit              517            1           .5          259       $93.74      $24,232
                                              Increase.
8.12(c)(2).................................  Diversion Control Plan.......          517            1           .5          259        93.74       24,232
8.635......................................  Annual Report................        1,350            1            3        4,050        64.47      261,104
8.640......................................  Renewal Request for a Patient            0            1           .5            0        93.74            0
                                              Limit Increase.
8.645......................................  Patient Notice...............            0            1            3            0        93.74            0
8.655(d)...................................  Request for a Temporary                 10            1            3           30        64.47        1,934
                                              Patient Increase for an
                                              Emergency.
                                                                           -----------------------------------------------------------------------------
    Total..................................  .............................        2,394  ...........  ...........        4,598  ...........      311,502
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Note that these estimates differ from those found in the RIA 
because the estimates here are wage cost estimates while the estimates 
in the RIA are resource cost estimates which incorporate costs 
associated with overhead and benefits.
    For more detailed estimates, please refer to the public docket, 
which includes a copy of the draft supporting statement associated with 
this information collection.

VI. Regulatory Impact Analysis

A. Introduction

    HHS has examined the impact of this proposed rule under Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act of 1980 (Pub. L. 96-
354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4, March 22, 1995), and Executive Order 13132 on 
Federalism (August 4, 1999).
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health, and safety 
effects; distributive impacts; and equity). Executive Order 13563 is 
supplemental to and reaffirms the principles, structures, and 
definitions governing regulatory review as established in Executive 
Order 12866. HHS expects that this proposed rule will have an annual 
effect on the economy of $100 million or more in at least 1 year and 
therefore is a significant regulatory action as defined by Executive 
Order 12866.
    The Regulatory Flexibility Act (RFA) requires agencies that issue a 
regulation to analyze options for regulatory relief of small businesses 
if a rule has a significant impact on a substantial number of small 
entities. The RFA generally defines a ``small entity'' as (1) a 
proprietary firm meeting the size standards of the Small Business 
Administration; (2) a nonprofit organization that is not dominant in 
its field; or (3) a small government jurisdiction with a population of 
less than 50,000 (States and individuals are not included in the 
definition of ``small entity''). HHS considers a rule to have a 
significant economic impact on a substantial number of small entities 
if at least 5 percent of small entities experience an impact of more 
than 3 percent of revenue. HHS anticipates that the proposed rule will 
not have a significant economic impact on a substantial number of small 
entities. We provide supporting analysis in section F.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) implicit 
price deflator for the gross domestic product. HHS expects this 
proposed rule to result in expenditures that would exceed this amount.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct requirement costs on State and local governments or has 
federalism implications. HHS has determined that the proposed rule, if 
finalized, would not contain policies that would have substantial 
direct effects on the States, on the relationship between the Federal 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. The proposed 
changes in the rule represent the Federal Government regulating its own 
program. Accordingly, HHS concludes that the proposed rule does not 
contain policies that have federalism implications as defined in 
Executive Order 13132 and, consequently, a federalism summary impact 
statement is not required.

B. Summary of the Proposed Rule

    Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows 
individual practitioners to dispense and prescribe Schedule III, IV, or 
V controlled substances that have been approved by the FDA specifically 
for use in maintenance and detoxification treatment without obtaining 
the separate registration required by 21 CFR 1301.13(e) and imposes a 
limit on the

[[Page 17650]]

number of patients a practitioner may treat at any one time.
    Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners 
who file an initial NOI to treat a maximum of 30 patients at a time. 
After one year, the practitioner may file a second NOI indicating his/
her intent to treat up to 100 patients at a time. To qualify, the 
practitioner must be a practitioner, possess a valid license to 
practice medicine, be a registrant of the DEA, have the capacity to 
refer patients for appropriate counseling and other appropriate 
ancillary services, and have completed required training. The training 
requirement may be satisfied in several ways: One may hold subspecialty 
board certification in addiction psychiatry from the American Board of 
Medical Specialties or addiction medicine from the American Osteopathic 
Association; hold an addiction certification from the American Society 
of Addiction Medicine (ASAM); complete an 8-hour training provided by 
an approved organization; have participated as an investigator in one 
or more clinical trials leading to the approval of a medication that 
qualifies to be prescribed under 21 U.S.C. 823(g)(2); or complete other 
training or have such other experience as the state medical licensing 
board or Secretary of HHS considers to demonstrate the ability of the 
practitioner to treat and manage persons with opioid use disorder.
    Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is 
authorized to promulgate regulations that change the total number of 
patients that a practitioner may treat at any one time.
    The laws pertaining to the utilization of buprenorphine were last 
revised approximately ten years ago at a time when the extent of the 
opioid public health crisis was less well-documented. The purpose of 
the proposed rule is to expand access to MAT with buprenorphine while 
encouraging practitioners administering buprenorphine to ensure their 
patients can receive the full array of services that comprise evidence-
based MAT and to minimize the risk of drug diversion. The proposed rule 
would revise the highest patient limit from 100 patients per 
practitioner with an existing waiver (waivered practitioner) to 200 
patients for practitioners who meet certain criteria in addition to 
those established in statute. Practitioners who have had a waiver to 
treat 100 patients for at least one year could obtain approval to treat 
up to 200 patients if they meet the requirements defined in this 
proposed rule and after submitting a Request for Patient Limit Increase 
to SAMHSA. Practitioners approved to treat up to 200 patients will also 
be required to accept greater responsibility for providing behavioral 
health services and care coordination, and ensuring quality assurance 
and improvement practices, diversion control, and continuity of care in 
emergencies. The higher limit will also carry with it the duty to 
regularly reaffirm the practitioner's ongoing eligibility and to 
participate in data reporting and monitoring as required by SAMHSA. In 
addition, practitioners in good standing with a current waiver to treat 
up to 100 patients (i.e., the practitioner has filed a NOI and 
satisfied all required criteria) may request approval to treat up to 
200 patients in specific emergency situations for a limited time period 
specified in the rule. We anticipate that qualifying emergency 
situations will occur very infrequently. As a result, we do not 
anticipate that this provision will contribute significantly to the 
impact of this proposed rule. SAMHSA will review all emergency 
situation requests, to the extent practicable, in consultation with 
appropriate governmental authorities before such requests are granted. 
Finally, the proposed rule defines patient limit in such a way that 
firmly ties the individual patient to the prescribing practitioner of 
record rather than to the covering practitioner at a given moment. This 
will enable waivered practitioners to provide reciprocal cross-coverage 
of patients for brief periods, such as weekends or vacations, without 
being considered to be in excess of their respective individual limits. 
Although this is a positive aspect of the proposed rule and will help 
to ensure continuity of care in select situations, we expect that this 
will primarily affect the timing of treatment rather than the quantity 
of treatment. As a result, we do not anticipate that this change will 
contribute significantly to the impact of this proposed rule, and we do 
not estimate the associated costs and benefits.

C. Need for the Proposed Rule

    The United States is facing an unprecedented increase in 
prescription opioid abuse, heroin use and opioid-related overdose 
deaths. In 2014, 18,893 overdose deaths involved prescription opioids 
and 10,574 involved heroin.\57\ Underlying many of these deaths is an 
untreated opioid use disorder.58 59 60 In 2014, more than 
2.2 million people met diagnostic criteria for an opioid use 
disorder.\61\
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    \57\ Center for Disease Control and Prevention, National Center 
for Health Statistics, National Vital Statistics System, Mortality 
File. (2015). Number and Age-Adjusted Rates of Drug-poisoning Deaths 
Involving Opioid Analgesics and Heroin: United States, 2000-2014. 
Atlanta, GA: Center for Disease Control and Prevention. Available at 
http://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf.
    \58\ Johnson EM, Lanier WA, Merrill RM, et al. Unintentional 
Prescription opioid-related overdose deaths: description of 
decedents by next of kin or best contact, Utah, 2008-2009. J Gen 
Intern Med. 2013;28(4):522-529.
    \59\ Hall AJ, Logan JE, Toblin RL, et al. Patterns of abuse 
among unintentional pharmaceutical overdose fatalities. JAMA. 
2008;300(22):2613-2620.
    \60\ Bohnert AS, Valenstein M, Bair MJ, et al. Association 
between opioid prescribing patterns and opioid overdose-related 
deaths. JAMA. 2011;305(13):1315-1321.
    \61\ Jones CM. Unpublished analysis of the 2014 National Survey 
on Drug Use and Health Public Use File. 2015.
---------------------------------------------------------------------------

    Beyond the increase in overdose deaths, the health and economic 
consequences of opioid use disorders are substantial. In 2011, the most 
recent year data are available, an estimated 660,000 emergency 
department visits were due to the misuse or abuse of prescription 
opioids, heroin, or both.\62\ A recent analysis estimated the costs 
associated with emergency department and hospital inpatient care for 
opioid abuse-related events in the United States was more than $9 
billion per year.\63\ The societal costs of prescription opioid abuse, 
dependence, and misuse in the United States in 2011 were estimated at 
$55.7 billion annually, not including societal costs related to heroin 
use.\64\
---------------------------------------------------------------------------

    \62\ Id..
    \63\ Chandwani HS, Strassels SA, Rascati KL, Lawson KA, Wilson 
JP. Estimates of charges associated with emergency department and 
hospital inpatient care for opioid abuse-related events. J Pain 
Palliat Care Pharmacother. 2013;27(3):206-13.
    \64\ Birnhaum HG, White AG, Schiller M, Waldman T, et al. 
Societal costs of prescription opioid abuse, dependence, and misuse 
in the United States. Pain Med. 2011;12(4):657-67.
---------------------------------------------------------------------------

    Beginning around 2006, the United States started to experience a 
significant increase in the rate of hepatitis C virus infections. The 
available epidemiology indicates this increase is largely due to the 
increased injection of prescription opioids and heroin.65 66 
In addition, in 2015, a large outbreak of HIV in a small rural 
community in Indiana was linked to injection of prescription opioids, 
primarily injection of the prescription opioid oxymorphone. Over 80 
percent

[[Page 17651]]

of the 135 cases, as of April 2015, identified in the outbreak were co-
infected with hepatitis C virus.\67\ The infectious disease 
consequences associated with opioid injection have been found to 
account for a substantial proportion of the economic burden and 
disability associated with opioid use disorders.\68\
---------------------------------------------------------------------------

    \65\ Suryaprasad AG, White JZ, Xu F, et al. Emerging epidemic of 
hepatitis C virus infections among young nonurban persons who inject 
drugs in the United States, 2006-2012. Clin Infect Dis 2014;59:1411-
9.
    \66\ Zibbell JE, Iqbal K, Patel RC, Suryaprasad A, et al. 
Increases in hepatitis C virus infection related to injection drug 
use related to injection drug use among persons aged <=30 years--
Kentucky, Tennessee, Virginia, and West Virginia, 2006-2012. MMWR 
Morb Mortal Wkly Rep. 2015;64(17):453-8.
    \67\ Conrad, supra note 17.
    \68\ Degenhardt L, Whiteford HA, Ferrari AJ, Charlson FJ, et al. 
Global burden of disease attributable to illicit drug use and 
dependence: findings from the Global Burden of Disease Study 2010. 
Lancet 2013;382(9904):1564-74.
---------------------------------------------------------------------------

    There is robust literature documenting the effectiveness and cost-
effectiveness of the use of buprenorphine in the treatment of opioid 
use disorder. Buprenorphine has been shown to increase treatment 
retention and to reduce opioid use, relapse risk, and risk behaviors 
that transmit HIV and hepatitis.69 70 71 72 73 74 Reductions 
in opioid-related mortality also have been shown for 
buprenorphine.75 76 77
---------------------------------------------------------------------------

    \69\ Clark RE, Baxter JD, Aweh G, O'Connell E, et al. Risk 
factors for relapse and higher costs among Medicaid members with 
opioid dependence or abuse: opioid agonists, comorbidities, and 
treatment history. J Subst Abuse Treat. 2015;57:75-80.
    \70\ Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine 
maintenance versus placebo or methadone maintenance for opioid 
dependence. Cochrane Database Syst Rev. 2014 Feb 6;2:CD002207. doi: 
10.1002/14651858.CD002207.pub4.
    \71\ Kraus ML, Alford DP, Kotz MM, et al. Statement of the 
American Society of Addiction Medicine consensus panel on the use of 
buprenorphine in office-based treatment of opioid addiction. J 
Addict Med. 2011;5 (4):254-263.
    \72\ Bonhomme J, Shim RS, Gooden R, Tyus D, Rust G. Opioid 
addiction and abuse in primary care practice: a comparison of 
methadone and buprenorphine as treatment options. J Natl Med Assoc. 
2012;104(7-8):342-350.
    \73\ Tsui JI, Evans JL, Lum PJ, Hahn JA, Page K. Association of 
opioid agonist therapy with lower incidence of hepatitis C virus 
infection in young adult injection drug users. JAMA Intern Med. 
2014;174(12):1974-1981.
    \74\ Woody GE, Bruce D, Korthuis PT, Chhatre S, et al. HIV risk 
reduction with buprenorphine-naloxone or methadone: findings from a 
randomized trial. J Acuir Immune Defic Syndr. 2015;68(5):554-61.
    \75\ Clark RE, Samnaliev M, Baxter JD, Leung GY. The evidence 
doesn't justify steps by state Medicaid programs to restrict opioid 
addiction treatment with buprenorphine. Health Aff (Millwood). 
2011;30(8):1425-1433.
    \76\ Schwartz RP, Gryczynski J, O'Grady KE, et al. Opioid 
agonist treatments and heroin overdose deaths in Baltimore, 
Maryland, 1995-2009. Am J Public Health. 2013;103(5):917-922.
    \77\ Carrieri MP, Amass L, Lucas GM, Vlahov D, Wodak A, Woody 
GE. Buprenorphine use: the international experience. Clin Infect 
Dis. 2006;43(suppl 4):S197-S215.
---------------------------------------------------------------------------

    Despite these well-documented benefits, buprenorphine treatment for 
opioid use disorder is significantly underutilized and often does not 
incorporate the full scope of recommended clinical practices that make 
up evidence-based MAT. Generally, there is significant unmet need for 
MAT treatment among individuals with opioid use disorders.\78\ There is 
also substantial geographic variation in the capacity to prescribe 
buprenorphine. Research suggests that 10 percent of the population live 
in areas where there is a shortage of practitioners eligible to 
prescribe buprenorphine or in counties that have no practitioners with 
a waiver to prescribe buprenorphine.\79\ These are primarily rural 
counties and areas located in the middle of the country.\80\ Only about 
5 percent of practitioners with the 100 patient limit are located in 
rural counties.\81\
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    \78\ Jones, supra note 53.
    \79\ Rosenblatt RA, Andrilla CH, Catlin M, Larson EH. Geographic 
and specialty distribution of US physicians trained to treat opioid 
use disorder. Ann Fam Med. 2015 Jan-Feb;13(1):23-6. doi: 10.1370/
afm.1735.
    \80\ Dick AW, Pacula RL, Gordon A.J, Sorbero M, et al. Growth in 
buprenorphine waivers for physicians increased potential access to 
opioid agonist treatment, 2002-11. Health Affairs 2015;34(6):1028-
1034.
    \81\ Stein BD, Pacula RL, Gordon AJ, Burns RM, et al. Where is 
buprenorphine dispensed to treat opioid use disorders? The role of 
private offices, opioid treatment programs, and substance abuse 
treatment facilities in urban and rural counties. Milbank Quarterly 
2015;93(3):56561-583.
---------------------------------------------------------------------------

    Evidence suggests that utilization of buprenorphine is limited 
directly by the existence of treatment caps. Practitioners currently 
providing MAT with buprenorphine under 21 U.S.C. 823(g)(2) report that 
being limited to treating not more than 100 patients at a time is a 
barrier to expanding treatment.82 83 84 A recent survey by 
ASAM found that among the 1,309 respondents (approximately 35 percent 
of ASAM's membership), comprising a range of addiction stakeholders, 
including those working in OTPs and outpatient or office-based practice 
settings, 544, or 41.6 percent, were currently treating more than 80 
patients, and 796, or 60.8 percent, reported there was demand for 
treatment in excess of the current 100 patient limit under the Drug 
Addiction Treatment Act of 2000 (Pub. L. 106-310).\85\ Increasing the 
number of patients that a single practitioner can treat with 
buprenorphine, then, could have a direct impact on buprenorphine 
capacity and utilization.
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    \82\ Molfenter T, Sherbeck C, Zehner M, Starr S. Buprenorphine 
Prescribing Availability in a Sample of Ohio Specialty Treatment 
Organizations. J Addict Behav Ther Rehabil. 2015;4(2). pii: 1000140.
    \83\ Molfenter T, Sherbeck C, Zehner M, Quanbeck A, et al. 
Implementing buprenorphine in addiction treatment: payer and 
provider perspectives in Ohio. Subst Abuse Treat Prev Policy. 
2015;10:13. doi: 10.1186/s13011-015-0009-2.
    \84\ Substance Abuse and Mental Health Services Administration, 
supra note 49.
    \85\ American Society of Addiction Medicine. 2015. Available at: 
http://www.asam.org/magazine/read/article/2015/12/08/addiction-specialists-weigh-in-on-the-data-2000-patient-limits.
---------------------------------------------------------------------------

    In addition to direct barriers to treating additional patients 
imposed by the patient limit, there are indirect barriers to expanding 
treatment capacity. In particular, increases in a practitioner's 
ability to expand his or her patient base will allow the practitioner 
to take advantage of economies of scale to increase the practice's 
efficiency. For example, a practitioner with a larger practice is more 
likely to be able to afford to hire specialized support staff, which 
allows the practitioner to reduce time spent on tasks best suited for 
another individual. This may help to enable the provision of the full 
complement of ancillary services that make up evidence-based MAT. 
Increasing a practitioner's maximum capacity for treatment has the 
potential to make treating patients with buprenorphine more 
economically feasible, which furthers the argument that these proposed 
changes will increase capacity to prescribe buprenorphine.
    The statutory change implemented in 2007 that increased the limit 
on the number of buprenorphine patients a practitioner could treat from 
30 to 100, after having a 30 patient limit for 1 year, was associated 
with a significant increase in the use of buprenorphine.\86\ In 2007, 
when practitioners were first able to treat up to 100 patients, nearly 
25 percent of eligible practitioners submitted a NOI to treat 100 
patients (1,937 practitioners out of 7,887 practitioners).\87\ The 
findings from the ASAM survey discussed above and additional 
information indicate there is sufficient demand from both providers and 
patients to raise the patient limit. In addition, based on the 
experience in 2007, it is expected that some proportion of eligible 
practitioners will respond to the proposed rule by submitting a Request 
for Patient Limit Increase to treat up to 200 patients.
---------------------------------------------------------------------------

    \86\ Stein supra note 82.
    \87\ Jones, supra note 53.
---------------------------------------------------------------------------

D. Analysis of Benefits and Costs

a. Increased Ability for Waivered Practitioners To Treat Patients With 
Buprenorphine-Based MAT
    This proposed rule directly expands opportunities for physicians 
who currently treat or who may treat patients with buprenorphine, as 
they will now have the potential to treat up to 200 patients with 
buprenorphine. We believe that this may translate to a

[[Page 17652]]

financial opportunity for these physicians, depending on the costs 
associated with treating these additional patients.
    Relatedly, this proposed rule may increase the value of the waiver 
to treat opioid use disorder under 21 U.S.C. 823(g)(2). The proposed 
rule would require practitioners to have a waiver to treat 100 patients 
for 1 year and to have a subspecialty board certification in addiction 
medicine, a subspecialty board certification in addiction psychiatry, 
or to practice in a qualified practice setting as defined in the rule 
in order to request approval to treat 200 patients. If getting to the 
200-patient limit provides sufficient benefits to practitioners, this 
proposed rule may also increase incentives for other practitioners to 
apply for the lower patient limit waivers, insofar as they are 
milestones towards the 200-patient cap. In addition, this rule may also 
make it more valuable for practitioners to have subspecialty board 
certifications in addiction medicine and addiction psychiatry, or to 
practice in a qualified practice setting. The proposed rule, then, may 
increase the number of practitioners in these categories and thus the 
number of practitioners eligible for the 200 patient limit in the 
future.
b. Increased Treatment for Patients
    Permitting practitioners to treat up to 200 patients will only be 
successful if it results in practitioners serving additional patients. 
As discussed previously, there are many reasons to expect this to 
happen as a result of finalization of this proposed rule. In addition, 
we expect that other factors could amplify the impact of the changes 
proposed in the rule. First, following the implementation of the 
Affordable Care Act, health insurance coverage has expanded 
dramatically in the United States. The uninsured rate among adults age 
18-64 declined from 22.3 percent in 2010 to 12.7 percent during the 
first 6 months of 2015.\88\ Further, the Affordable Care Act expanded 
coverage includes populations at high-risk for opioid use disorders 
that previously did not have sufficient access to health insurance 
coverage.\89\ Second, parity protections from the Mental Health Parity 
and Addiction Equity Act and the Affordable Care Act will include 
coverage for mental health and substance use disorder treatment that is 
comparable to medical and surgical coverage in many types of insurance 
policies. Insurance coverage and cost of treatment are often cited as 
important reasons that individuals seeking treatment have not used 
buprenorphine.90 91 92 93 A NPRM to extend parity 
protections to Medicaid managed care was released in the spring of 
2015. These changes in health insurance coverage should improve access 
to substance use disorder treatment, including buprenorphine.
---------------------------------------------------------------------------

    \88\ Centers for Disease Control and Prevention. Health 
insurance coverage: early release of estimates from the National 
Health Interview Survey, January-June 2015. Available at: http://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201511.pdf.
    \89\ Jones, supra note 53.
    \90\ Volkow, supra note 38.
    \91\ Sohler NL, Weiss L, Egan JE, et al. Consumer attitudes 
about opioid addiction treatment: a focus group study in New York 
City. J Opioid Manag. 2013;9(2):111-119.
    \92\ . Greenfield BL, Owens MD, Ley D. Opioid use in 
Albuquerque, New Mexico: a needs assessment of recent changes and 
treatment availability. Addict Sci Clin Pract. 2014;9:10. doi: 
10.1186/1940-0640-9-10.
    \93\ American Society of Addiction Medicine. State Medicaid 
coverage and authorization requirements for opioid dependence 
medications. 2013. Available at: http://www.asam.org/docs/advocacy/Implications-for-Opioid-Addiction-Treatment.
---------------------------------------------------------------------------

c. Increased Time To Treat Patients
    Lack of practitioner time to treat patients with opioid use 
disorder, which includes a patient exam, medication consultation, 
counseling, and other appropriate treatment services, and lack of 
behavioral health staff to provide these ancillary services, are 
additional barriers to providing MAT with buprenorphine in the office-
based setting.94 95 These barriers could be addressed by 
leveraging the time and skills of clinical support staff, such as 
nurses and clinical social workers. For example, in Massachusetts and 
Vermont, nurses provide screening, intake, education, and other 
ancillary services for patients treated with buprenorphine. This 
enables practitioners to treat additional patients and to provide the 
requisite psychosocial services.96 97 98 However, in order 
to afford a nurse or other clinician dedicated to providing evidence-
based treatment for an opioid use disorder, practitioners need a 
minimum volume of patients. Allowing practitioners to treat up to 200 
patients at a time would be a step towards supporting practitioners 
that seek to hire nurses and other clinical staff to reduce 
practitioners' time requirements and to provide the ancillary services 
of high-quality MAT with buprenorphine. This impact of leveraging non-
physicians to facilitate expanded access to buprenorphine has been 
demonstrated in both Vermont and Massachusetts.99 100
---------------------------------------------------------------------------

    \94\ Hutchinson E, Catlin M, Andrilla CH, Baldwin LM, Rosenblatt 
RA. Barriers to primary care physicians prescribing buprenorphine. 
Ann Fam Med. 2014 Mar-Apr;12(2):128-33.
    \95\ DeFlavio JR, Rolin SA, Nordstrom BR, Kazal LA Jr. Analysis 
of barriers to adoption of buprenorphine maintenance therapy by 
family physicians. Rural RemoteHealth. 2015;15:3019. Epub 2015 Feb 
4.
    \96\ Alford D, LaBelle C, Richardson J, O'Connell J, et al. 
Treating homeless opioid dependent patients with buprenorphine in an 
office-based setting. Society of General Internal Medicine. 2007; 
22: 171-176.
    \97\ Labelle, C. Nurse Care Manager Model. http://buprenorphine.samhsa.gov/presentations/LaBelle.pdf.
    \98\ State of Vermont: Concept for Medicaid Health Home Program 
http://hcr.vermont.gov/sites/hcr/files/VT_SPA_Concept_Paper_final_CMS_10_02_12.pdf.
    \99\ LaBelle CT, Han SC, Bergeron A, Samet JH. Office-Based 
Opioid Treatment with Buprenorphine (OBOT-B): Statewide 
Implementation of the Massachusetts Collaborative Care Model in 
Community Health Centers. J Subst Abuse Treat. 2016;60:6-13.
    \100\ Vermont Department of Health. The effectiveness of 
Vermont's System of Opioid Addiction Treatment. 2015. Available at: 
http://legislature.vermont.gov/assets/Legislative-Reports/Opioid-system-effectiveness-1.14.15.pdf.
---------------------------------------------------------------------------

    Discussions with stakeholders about approaches to expanding access 
to MAT, including the use of buprenorphine-based MAT, suggest that 
expanding the patient limit in general will result in increased 
efficiencies in treating opioid use disorder patients. It will allow 
treating practitioners to provide the physician-appropriate services 
consistent with their waiver. It will provide more efficient supportive 
care, not related to prescribing or administering buprenorphine-
containing products, by allowing the treating practitioner to supervise 
this care, which can be provided by physician assistants, nurse 
practitioners, nurse case managers, and other behavioral health 
specialists.
d. Federal Costs Associated With Disseminating Information About the 
Rule
    Following publication of a final rule that builds upon this 
proposal and public comments, SAMHSA will work to educate providers 
about the requirements and opportunities for requesting and obtaining 
approval to treat up to 200 patients under 21 U.S.C. 823(g)(2). SAMHSA 
will prepare materials summarizing the changes as a result of the final 
rule, and provide these materials to practitioners potentially affected 
by the rulemaking upon publication of the final rule. SAMHSA has 
already established channels for disseminating information about rule 
changes to stakeholders, it is estimated that preparing and 
disseminating these materials will cost approximately $40,000, based 
upon experience soliciting public comment on past rules and 
publications such as

[[Page 17653]]

the Federal Opioid Treatment Program Standards.
e. Practitioners Costs To Evaluate the Policy Change
    We expect that, if this proposed rule is finalized, practitioners 
potentially affected by this proposed policy change will process the 
information and decide how to respond. In particular, they will likely 
evaluate the requirements and opportunities associated with the ability 
to treat up to 200 patients, and decide whether or not it is 
advantageous to pursue approval to treat up to 200 patients and make 
any necessary changes to their practice, such as obtaining subspecialty 
board certifications in either addiction medicine or addiction 
psychiatry, or the ability to treat patients in a qualified practice 
setting.
    We estimate that practitioners may spend an average of thirty 
minutes processing the information and deciding what action to take. 
According to the U.S. Bureau of Labor Statistics,\101\ the average 
hourly wage for a physician is $93.74. After adjusting upward by 100 
percent to account for overhead and benefits, we estimate that the per-
hour cost of a physician's time is $187.48. Thus, the cost per 
practitioner to process this information and decide upon a course of 
action is estimated to be $93.74. SAMHSA will disseminate information 
to an estimated 50,000 practitioners, which includes practitioners with 
a waiver to prescribe buprenorphine (i.e., approximately 30,000 
practitioners as of December 2015) and those who are reached through 
SAMHSA's dissemination network (i.e., 20,000 practitioners). For 
purposes of analysis we assume that 75 percent of these practitioners 
will review this information, and, as a result, we estimate that 
dissemination will result in a total cost of $3.5 million.
---------------------------------------------------------------------------

    \101\ U.S. Bureau of Labor Statistics. National Occupational 
Employment and Wage Estimates. Retrieved from: http://www.bls.gov/oes/current/oes_nat.htm#29-0000.
---------------------------------------------------------------------------

f. Practitioner Costs To Submit a Request for Patient Limit Increase
    Practitioners who want to treat up to 200 patients at a given time 
are required to submit a Request for Patient Limit Increase form to 
SAMHSA. The proposed form is three pages in length. We estimate that 
the form takes a practitioner an average of 1 hour to complete the 
first time it is completed, implying a cost of $187.48 per submission 
after adjusting upward by 100 percent to account for overhead and 
benefits. A draft Request for Patient Limit Increase form is available 
in the docket. We seek comment on our assumptions regarding the time 
required to complete the form.
    We do not have ideal information with which to estimate the number 
of practitioners who will submit a Request for Patient Limit Increase 
form in response to this proposed rule, and we therefore acknowledge 
uncertainty regarding the estimate of the total associated cost. 
However, based on the experience with the patient limit increase from 
30 to 100 implemented in 2007 102 103, the results of the 
2015 ASAM survey described earlier, and discussions with stakeholders, 
we estimate that between 500 and 1,800 practitioners will request 
approval to treat 200 patients within the first year of the proposed 
rule. We estimate that between 100 and 300 additional practitioners 
will request approval to treat 200 patients in each of the subsequent 4 
years. This would result in 600 to 2,100 practitioners in the second 
year, 700 to 2,400 practitioners in the third year, 800 to 2,700 in the 
fourth year, and 900 to 3,000 practitioners in the fifth year. We use 
the midpoint of each of these ranges to estimate costs and benefits in 
the first 5 years following publication of the final rule. This would 
result in a range of $93,740 to $337,464 in costs related to Request 
for Patient Limit Increase submissions in the first year. We seek 
comment on information which will allow us to refine our estimate of 
the number of practitioners who will submit a Request for Patient Limit 
Increase in response to this proposed rule.
---------------------------------------------------------------------------

    \102\ Arfken, supra note 54.
    \103\ Jones, supra note 53.

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

g. Practitioner Costs To Resubmit a Request for Patient Limit Increase
    After approval, a practitioner would need to resubmit a Request for 
Patient Limit Increase every 3 years to maintain his or her waiver to 
treat up to 200 patients. A practitioner would use the same 3-page 
Request for Patient Limit Increase used for an initial waiver request. 
We estimate that this will take 30 minutes because practitioners will 
be more familiar with the Request for Patient Limit Increase. 
Consistent with the physician wage estimate above, we estimate that 
resubmissions will require a practitioner an average of 30 minutes to 
complete, implying a cost of $93.74 per resubmission. To calculate 
costs associated with resubmission, we assume that all physicians who 
submit a Request for Patient Limit Increase will submit a renewal 3 
years later. Our estimates are summarized in the table below.

------------------------------------------------------------------------
                                             Number of
                                             renewals        Cost ($)
------------------------------------------------------------------------
Year 1-3................................               0               0
Year 4..................................           1,150        $108,000
Year 5..................................             200          19,000
                                         -------------------------------
    Total...............................           1,350         127,000
------------------------------------------------------------------------


[[Page 17654]]

h. Private-Sector Costs Associated With Newly Applying for Any Waiver
    Practitioners may also be interested in the ability to eventually 
treat up to 200 patients, and may make changes toward achieving that 
goal. As discussed previously, these proposed changes may increase the 
number of practitioners who apply for a waiver to treat 30 or 100 
patients. This would require practitioners to complete the required 
training, possess a valid license to practice medicine, be a registrant 
of DEA, and have the capacity to refer patients for appropriate 
counseling and other appropriate ancillary services. In addition, these 
proposed changes could increase the number of practitioners who seek 
subspecialty board certifications in either addiction medicine or 
addiction psychiatry or meet the requirements for practicing in a 
qualified practice setting as outlined in the proposed rule. This would 
likely include practice experience requirements, fees and time 
associated with preparing for and taking an exam, time and fees for 
continuing medical education requirements, and payment of certification 
fees.
    We do not have information to estimate the number of practitioners 
who will change behavior along these dimensions in response to this 
proposed rule. We seek comment on information which will allow us to 
estimate the number of practitioners who would apply to treat 
additional patients, the number who will seek additional subspecialty 
board certifications, and the number who will move toward meeting the 
requirements for treating in a qualified practice setting in response 
to the proposed changes.
i. Federal Costs Associated With Processing New 200 Patient Limit 
Waivers
    In addition to the costs associated with practitioners seeking 
approval for the higher patient limit, costs will be incurred by SAMHSA 
and DEA in order to process the additional Requests For Patient Limit 
Increase generated by the proposed rule. For purposes of analysis, and 
based on contractor estimates, SAMHSA estimates that it will pay a 
contractor $100 to process each waiver. As discussed previously, we 
estimate that between 500 and 1,800 practitioners will request approval 
to treat 200 patients within the first year of the rule, and between 
100 and 300 additional practitioners will request approval to treat 200 
patients in each of the subsequent 4 years. In addition, we estimate 
that physicians will resubmit 500 to 1,800 renewals in year 4, and 100 
to 300 renewals in year 5. As a result, we estimate costs to SAMHSA to 
process these waivers of $50,000-$180,000 in year 1, $10,000-$30,000 in 
year 2, $10,000-$30,000 in year 3, $60,000-$210,000 in year 4, and 
$20,000-$60,000 in year 5 following publication of the final rule. We 
estimate that DEA will allocate the equivalent of 1 FTE at the GS-11 
level to process the additional requests coming to DEA for issuance of 
a new DEA number designating the provider as eligible to prescribe 
buprenorphine for the treatment of opioid use disorder as a result of 
this proposed rule. We estimate the associated cost is $144,238, which 
we arrive at by multiplying the salary of a GS-11 employee at step 5, 
which is $72,219 in 2015, by two to account for overhead and benefits.
j. Costs of New Treatment
    Once requests to treat up to 200 patients generated by the proposed 
rule are processed, approved practitioners would be able to increase 
the number of patients they treat with buprenorphine. These patients, 
then, could utilize additional medical services that are consistent 
with the expectations for high-quality, evidence-based MAT proposed in 
the rule. We estimate the cost for buprenorphine and these additional 
medical services, including behavioral health and psychosocial 
services, as a result of the proposed rule to total $4,349 per patient 
per year, as described below.
    This estimate was derived using claims data from the 2009-2014 
Truven Health MarketScan[supreg] database. According to the 
MarketScan[supreg] data, the annual cost of buprenorphine prescriptions 
and ancillary services received totaled $3,500 for individuals with 
private insurance and $3,410 for individuals with Medicaid. 
Specifically, the average annual cost of buprenorphine prescriptions 
was $2,100 for commercial insurance based on receipt of an average of 
seven buprenorphine prescriptions annually and $2,600 for Medicaid 
based on receipt of an average of 10 buprenorphine prescriptions 
annually.
    According to the MarketScan[supreg] data, approximately 69 percent 
of Medicaid patients and 45 percent of privately insured patients 
received an outpatient psychosocial service related to substance use 
disorder in addition to their buprenorphine prescription. The average 
number of visits among those who received any psychosocial service was 
eight for privately insured patients at an average cost of $3,000 per 
year and 10 for Medicaid patients at an average cost of $1,100 per 
year. We assumed that the quality of care would increase among patients 
treated by practitioners with the 200-patient limit due to the extra 
oversight and quality of care requirements in the proposed rule. 
Specifically, we assumed that 80 percent of patients would receive 
outpatient psychosocial services. This would raise the cost of 
providing MAT with buprenorphine to $4,590 for commercial insurance and 
$3,525 for Medicaid beneficiaries. Based on data from IMS Health, it is 
estimated that approximately 18 percent of individuals receiving MAT 
with buprenorphine are Medicaid enrollees. Thus, we arrived at the 
estimated average cost for individuals new to the treatment system as a 
result of the proposed rule to be $4,349 per patient per year.
    The total resource costs associated with additional treatment is 
the product of additional treatment costs per person and the number of 
people who will receive additional treatment as a result of the 
proposed rule. For purposes of analysis, we assume that each 
practitioner who requests approval to treat 200 patients will treat 
between 20 and 40 additional patients each year. This is based on our 
experience with the increase from the 30 patient limit to the 100 
patient limit.104 105 We note that in that case, there were 
no new costs imposed on practitioners beyond those associated with 
additional treatment, whereas in this proposed rule there are new costs 
beyond those associated with additional treatment. However, applying 
this assumption would result in an estimated range of 10,000 to 72,000 
additional patients treated in the first year; and an additional 2,000 
to 12,000 patients in each subsequent year. To estimate costs 
associated with this increase in the number of patients, we assume 
that, on average, each physician will treat the equivalent of 30 full-
time patients (i.e., some patients might receive fewer services and 
others might receive more, but for cost estimates we assume it averages 
out to the equivalent of 30 patients receiving the full spectrum of 
care).We use these ranges to estimate costs and benefits of the rule as 
proposed. Based on this information, we estimate the treatment costs 
associated with new patients receiving treatment with buprenorphine as 
a result of this proposed rule will be between $43.5 million and $313 
million in the first year with a central estimate of $150 million, and 
an additional $8.7 million to $52.2 million in each subsequent year 
with a central estimate of $26.1 million. We seek comment on 
information which

[[Page 17655]]

will allow us to refine our efforts to quantify the number of people 
who may receive additional treatment with buprenorphine as a result of 
this proposed rule.
---------------------------------------------------------------------------

    \104\ Arfken, supra note 54.
    \105\ Jones, supra note 53.

------------------------------------------------------------------------
                                            Additional
                                              people         Treatment
                                             receiving         costs
                                             treatment      (Millions)
------------------------------------------------------------------------
Year 1..................................          34,500            $150
Year 2..................................          40,500             176
Year 3..................................          46,500             202
Year 4..................................          52,500             228
Year 5..................................          58,500             254
------------------------------------------------------------------------

    Evidence suggests that the benefits associated with additional 
buprenorphine utilization are likely to exceed their cost. One study 
estimated the costs and Quality Adjusted Life Year (QALY) gains 
associated with long-term office-based treatment with buprenorphine-
naloxone for clinically stable opioid-dependent patients compared to no 
treatment. The authors estimate total treatment costs over 2 years of 
$7,700 and an associated 0.22 QALY gain compared to no treatment in 
their base case.106 107. Following a food safety rule 
recently published by FDA,\108\ we use a value of $1,260 per quality-
adjusted life day. This implies a value of $460,215 ($1,260 *365.25) 
per QALY, which we use to monetize the health benefits here. As a 
result, we estimate average annual benefits ranges of $51,000 per 
person who achieves 6 months of clinical stability. In the absence of 
data on the percentage of patients newly receiving buprenorphine 
treatment who would achieve this status, we illustrate the calculation 
of rule-induced benefits using 100 percent as an input. We acknowledge 
that this approach would, all else equal, lead to overestimation of 
health benefits and request comment that would allow for refinement of 
the estimates. As a result, we estimate monetized health benefits of 
$1,747 million in the first year, with estimated monetized health 
benefits rising by $304 million in each subsequent year as more 
individuals receive treatment as a result of the rule. These monetized 
health benefits are summarized below. We acknowledge that this approach 
may underestimate or overestimate health benefits and request comment 
that would allow for refinement of the estimates. We also explore the 
sensitivity of these results to our assumptions regarding the health 
benefits related to treatment in our section on sensitivity analysis.
---------------------------------------------------------------------------

    \106\ Schackman BR, Leff JA, Polsky D, Moore BA, Fiellin DA. 
Cost-Effectiveness of Long-Term Outpatient Buprenorphine-Naloxone 
Treatment for Opioid Dependence in Primary Care. Journal of General 
Internal Medicine. 2012;27(6):669-676. doi:10.1007/s11606-011-1962-
8.
    \107\ These results omit lost utility associated with the 
illegal consumption of heroin or other opioids. Such omission is 
consistent with Zerbe, R.O. Is Cost-Benefit Analysis Legal? Three 
Rules. Journal of Policy Analysis and Management 17(3): 419-456, 
1998.
    \108\ This RIA can be found here: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472330.pdf

------------------------------------------------------------------------
                                            Additional       Monetized
                                              people          health
                                             receiving       benefits
                                             treatment      (millions)
------------------------------------------------------------------------
Year 1..................................          34,500          $1,747
Year 2..................................          40,500           2,050
Year 3..................................          46,500           2,354
Year 4..................................          52,500           2,658
Year 5..................................          58,500           2,961
------------------------------------------------------------------------

k. Potential for Diversion
    While we expect many benefits associated with this proposed rule, 
it is possible that there would be unintended negative consequences. 
First, prior research looked at Utah statewide increases in 
buprenorphine use and the number of reported pediatric exposures, and 
found that as buprenorphine use increased between 2002 and 2011, the 
number of unintentional pediatric exposures in the State 
increased.\109\ Thus, it is possible that the increased utilization of 
buprenorphine as a result of this proposed rule without appropriate 
patient counseling and action to ensure the safe use, storage, and 
disposal of buprenorphine, may lead to an increase in unintentional 
pediatric exposures. In addition, there has been an increase in 
diversion of buprenorphine as use of the product has increased. 
According to the National Forensic Laboratory Information System 
(NFLIS)--a system used to track diversion-buprenorphine is the third 
most common narcotic analgesic reported in NFLIS, with 15,209 cases 
reported in 2014. This represents 12.4 percent of all narcotic 
analgesic cases in NFLIS in 2014.\110\
---------------------------------------------------------------------------

    \109\ Centers for Disease Control and Prevention. Buprenorphine 
prescribing practices and exposures reported to a poison center--
Utah, 2002-2011. MMWR 2012;61:997-1001.
    \110\ Drug Enforcement Administration. National Forensic 
Laboratory Information System. 2014 Annual Report. Available at: 
https://www.nflis.deadiversion.usdoj.gov/Reports.aspx.
---------------------------------------------------------------------------

    It is important to note that studies have found that the motivation 
to divert buprenorphine is often associated with lack of access to 
treatment or using the medication to manage withdrawal--as opposed to 
diversion for the medication's psychoactive effect.111 112 
Thus, the overall effect of this rulemaking on diversion is not clear 
given that the increased utilization of buprenorphine could affect the 
opportunity for diversion, but also could, in some cases, reduce 
diversion because of improved access to high-quality, evidence-based 
buprenorphine treatment.
---------------------------------------------------------------------------

    \111\ Lofwall MR, Havens JR. Inability to access buprenorphine 
treatment as a risk factor for using diverted buprenorphine. Drug 
Alcohol Depend. 2012;126(3):379-83.
    \112\ Genberg BL, Gillespie M, Schuster CR, Johanson CE, et al. 
Prevalence and correlates of street-obtained buprenorphine use among 
current and former injectors in Baltimore, Maryland. Addict Behav. 
2013;38(12):2868-73.
---------------------------------------------------------------------------

    Moreover, to reduce the risk of diversion, one of the additional 
requirements placed on providers who seek the 200 patient limit is 
implementation of a diversion control plan. However, it is possible 
that State and local law enforcement could incur additional costs if 
diversion increases as a result of this proposed rule. We do not have 
sufficient information to estimate the extent to which these unintended 
consequences could occur.
l. Practitioner Reporting Requirements
    Under this proposed rule, as outlined earlier, practitioners 
approved to treat up to 200 patients would have to submit information 
about their practice annually to SAMHSA for purposes of monitoring 
regulatory compliance. The goal of the reporting requirement is to 
ensure that practitioners are providing high-quality, evidence-based 
buprenorphine treatment. It is anticipated that the data for the 
reporting requirement can be pulled directly from an electronic or 
paper health record, and that practitioners would not have to update 
their record-keeping practices after receiving approval to treat 200 
patients. We estimate that compiling and submitting the report would 
require approximately 1 hour of physician time and 2 hours of 
administrative time. According to the U.S. Bureau of Labor Statistics 
\89\, the average medical and health services manager's hourly pay in 
2014 was $49.84, which corresponds to a cost of $99.68 per hour after 
adjusting upward by 100 percent to account for overhead and benefits. 
Therefore, the cost of this reporting requirement per practitioner 
approved for the 200 patient limit is estimated to be the cost of 1 
hour of a practitioner's time plus an hour of an administrator's time.
    As noted above, using the mid-point estimate, we estimate that 
1,150 practitioners will request a 200-patient waiver in year 1 and 200 
practitioners will request a 200-patient waiver in subsequent years. We 
assume that all of these requests will be approved. The costs 
associated with this reporting

[[Page 17656]]

requirement are reported below. In addition, it is estimated that 
SAMHSA will incur a cost of $100 per practitioner approved for the 200 
patient limit to process the practitioner data reporting requirement. 
These costs are reported below as well.
    DEA may also incur costs in association with this proposed rule if, 
for example, DEA increases the number of site visits they conduct 
because providers are treating more than 100 patients. We tentatively 
assume that DEA will incur no costs as a result of these reporting 
requirements, and we seek comment on this assumption.

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

m. Costs Associated With Waiver Requests in Emergencies
    Under the proposed rule, practitioners in good standing with a 
current waiver to treat up to 100 patients may request temporary 
approval to treat up to 200 patients in specific emergency situations. 
As discussed previously, we anticipate that qualifying emergency 
situations will occur very infrequently. We estimate that practitioners 
will request ten of these waivers in each year. We estimate that 
requesting this waiver would require approximately 1 hour of physician 
time and 2 hours of administrative time, and responding to the request 
would require resources approximately equivalent to responding the 
three Requests for Patient Limit Increase submissions, which is $300. 
As a result, we estimate that this requirement is associated with costs 
of approximately $7,000 in each year following publication of the final 
rule. We seek comment on the assumptions in this section.
n. Summary of Impacts
    The proposed rule's impacts will take place over a long period of 
time. As discussed previously, we expect the existence of the waiver to 
treat 200 patients will increase the desirability of waivers to treat 
30 and 100 patients. This implies that more practitioners will work 
toward fulfilling the requirements associated with receiving these 
waivers. Further, this may make practitioners early in their career 
more likely to choose addiction medicine or addiction psychiatry as 
their specialty. All of this implies that the proposed rule will have a 
growing impact on capacity to prescribe buprenorphine as time passes. 
Since the lack of capacity to treat patients using buprenorphine is a 
barrier to its utilization, this suggests that the proposed rule will 
lead to growing increases in the utilization of buprenorphine, and 
growing increases in the associated positive health and economic 
effects.
    The following table presents these costs and benefits over the 
first 5 years of the proposed rule.

                         Accounting Table of Benefits and Costs of All Proposed Changes
----------------------------------------------------------------------------------------------------------------
                                                   Present value over 5 years by   Annualized value over 5 years
                                                    discount rate (millions of    by discount rate  (millions of
                    BENEFITS                               2014 dollars)                   2014 dollars)
                                                 ---------------------------------------------------------------
                                                     3 Percent       7 Percent       3 Percent       7 Percent
----------------------------------------------------------------------------------------------------------------
Quantified Benefits.............................          11,019          10,148           2,336           2,313
----------------------------------------------------------------------------------------------------------------
                      COSTS                          3 Percent       7 Percent       3 Percent       7 Percent
----------------------------------------------------------------------------------------------------------------
Quantified Costs................................             955             880             203             201
----------------------------------------------------------------------------------------------------------------

E. Sensitivity Analysis

    The total estimated benefits of the changes proposed here are 
sensitive to assumptions regarding the number of practitioners who will 
seek a waiver to treat 200 patients as a result of the proposed rule, 
the number of individuals who will receive MAT as a result of the 
proposed rule, the average per-person health benefits associated with 
this additional treatment, and the dollar value of these health 
improvements. We estimate that 500 to 1,800 practitioners will apply 
for a waiver to treat up to 200 patients in the first year, and 100 to 
300 practitioners will apply for a waiver to treat up to 200 patients 
in subsequent years following publication of the final rule, with 
central estimates at the midpoint of each range. For alternative 
estimates in these ranges using a 3 percent discount rate, all else 
equal, we estimate annualized benefits ranging from $1,054 million to 
$3,618 million and annualized costs ranging from $92 million to $313 
million.
    We estimate that practitioners who receive a waiver to treat 200 
patients will treat between 20 and 40 additional patients each year, 
with a central estimate of an average of 30 additional patients. For 
alternative estimates of 20 to 40 additional patients per year, all 
else equal, we estimate annualized benefits using a 3 percent discount 
rate ranging from $1,557 million to $3,115 million over the 5 years 
following implementation.
    We estimate that individuals who receive MAT as a result of the 
proposed rule will experience average health improvements equivalent to 
0.11 QALYs. For alternative estimates of these health improvements 
between 0.06 and 0.16 QALYs, all else equal, we estimate annualized 
benefits using a 3 percent discount rate ranging from $1,274 million to 
$3,398 million over the 5 years following implementation. To estimate 
the dollar value of health benefits, we use a value of approximately 
$460,000 per QALY. For

[[Page 17657]]

alternative values per QALY between $300,000 and $600,000, all else 
equal, we estimate annualized benefits using a 3 percent discount rate 
ranging from $1,523 million to $3,046 million over the 5 years 
following implementation.
    Alternative assumptions along these four dimensions, when varied 
together, using a 3 percent discount rate, imply annualized benefit 
estimates ranging from $250 million to $9,148 million and annualized 
cost estimates ranging from $62 million to $417 million. We note that, 
in all scenarios discussed in this section, annualized benefits 
substantially exceed annualized costs. There are, however, 
uncertainties not reflected in this sensitivity analysis, which might 
lead to net benefits results that are smaller or larger than the range 
of estimates summarized in the following table.

                                Low, High, and Primary Benefit and Cost Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Annualized Value over 5 Years 3% Discount Rate
                                                                             (Millions of 2014 Dollars)
                            BENEFITS                             -----------------------------------------------
                                                                        Low           Primary          High
----------------------------------------------------------------------------------------------------------------
Quantified Benefits.............................................             250           2,336           9,148
Quantified Costs................................................              62             203             417
----------------------------------------------------------------------------------------------------------------

F. Analysis of Regulatory Alternatives

    We carefully considered the option of not pursuing regulatory 
action. However, existing evidence indicates that opioid use disorder 
and its related health consequences is a substantial and increasing 
public health problem in the United States, and it can be addressed by 
increasing access to effective treatment. As discussed previously, the 
lack of sufficient access to treatment is directly affected by the 
existing limit on the number of patients each practitioner with a 
waiver can currently treat using buprenorphine, and removing this 
barrier to access is very likely to increase the provision of this 
treatment. Finally, the provision of MAT with buprenorphine provides 
tremendous benefits to the individual who experiences health gains 
associated with treatment, as well as to society which bears smaller 
costs associated with the negative effects of opioid use disorders. 
These benefits are expected to greatly exceed the costs associated with 
increases in treatment. As a result, we expect the benefits of the 
proposed regulatory action to exceed its costs.
    We also considered allowing practitioners waivered to treat up to 
100 patients to apply for the higher prescribing limit without having 
to meet the specialty board certification or qualified practice setting 
requirements as defined in the proposed rule. One important objective 
of this proposed rule is to expand access while mitigating the risks 
associated with expanded access. In addition, the effects of this rule 
are difficult to project, leading us to adopt a conservative approach 
to increasing access. Given the complexity of the condition, the 
increased potential for diversion associated with a higher prescribing 
limit, and the need to ensure high quality care, it was determined that 
addiction specialist physicians and those with the infrastructure and 
capacity to deliver the full complement of services recommended by 
clinical practice guidelines would be best suited to balance these 
concerns.
    Finally, we considered the alternative of having no reporting 
requirement for physicians with the 200-patient limit. Although this 
alternative would reduce the 1 hour of physician time and 2 hours of 
administrative time estimated for data reporting in our analysis, we 
did not pursue this alternative. The reporting requirements are 
intended to reinforce recommendations included in clinical practice 
guidelines on the delivery of high quality, effective, and safe patient 
care. Specifically, nationally-recognized clinical guidelines on 
office-based opioid treatment with buprenorphine suggest that optimal 
care include administration of the medication and the use of 
psychotherapeutic support services. They also recommend that physicians 
and practices prescribing buprenorphine for the treatment of opioid use 
disorder in the outpatient setting take steps to reduce the likelihood 
of buprenorphine diversion. Each of these tenets is reflected in the 
proposed reporting requirements.

G. Regulatory Flexibility Analysis

    As discussed above, the RFA requires agencies that issue a 
regulation to analyze options for regulatory relief of small entities 
if a rule has a significant impact on a substantial number of small 
entities. The categories of entities affected most by this proposed 
rule will be offices of practitioners and hospitals. We expect that the 
vast majority of these entities will be considered small based on the 
Small Business Administration size standards or non-profit status, and 
assume here that all affected entities are small. According to SAMHSA 
data, as of March 2016 there were 32,123 practitioners with a waiver to 
prescribe buprenorphine for the treatment of opioid use disorder. This 
group of practitioners is most likely to be impacted by the proposed 
rule, but we lack information on the total number of associated 
entities. We acknowledge that some practitioners with a waiver may 
provide services at multiple entities, many entities may employ 
multiple practitioners with a waiver, and some entities currently 
unaffiliated with these practitioners will be impacted by this proposed 
rule. As a result, we estimate that approximately 32,123 small entities 
will be affected by this proposed rule.
    HHS considers a rule to have a significant economic impact on a 
substantial number of small entities if at least 5 percent of small 
entities experience an impact of more than 3 percent of revenue. As 
discussed above, the proposed rule imposes a small burden on entities. 
This burden is primarily associated with processing information 
disseminated by SAMHSA, opting to completing the waiver process to 
treat additional patients, and submitting information after receiving a 
waiver to treat 200 patients, which are estimated to take a maximum of 
4 hours per practitioner in any given year. This represents less than 1 
percent of hours worked for an individual working full-time. Further, 
this proposed rule does not require practitioners to undertake these 
burdens, as this rulemaking does not require practitioners to seek a 
waiver to treat 200 patients. As a result, we anticipate that this 
proposed rule will not have a significant impact on a substantial 
number of small entities. We seek comment on the assumptions used in 
this section, and on the proposed rule's burden on small entities.

[[Page 17658]]

VII. Agency Questions for Comment

    If any of the comments fall under any of the following questions, 
please indicate the question and number with your response.
    (1) Evidence Supporting an Optimal Patient Prescribing Limit--This 
proposed rule is intended to improve patient access to buprenorphine 
for the treatment of opioid use disorder while also minimizing the risk 
of diversion and patient safety concerns. Based on the available 
information, including clinical guideline recommendations and expert 
stakeholder input, HHS is proposing a new 200-patient prescribing 
limit. HHS seeks comment that provides evidence that an alternate 
prescribing limit would be more appropriate than the one proposed in 
this rulemaking.
    (2) Potential New Formulations--The Secretary shall establish a 
process by which patients who are treated with medications covered 
under 21 U.S.C. 823(g)(2)(C), and that have features that enhance 
safety or reduce diversion, as determined by the Secretary, may be 
counted differently toward the prescribing limit established in this 
proposed rule. The criteria for determining which if any of these 
medications or reformulations of existing medications may be 
considered, and how these patients will be counted toward the patient 
limit, will be based on the following principles:
    a. Relative risk of diversion associated with medications that 
become covered under 21 U.S.C. 823(g)(2)(C) after the effective date of 
this proposed rule; and
    b. Time required to monitor patient safety, assure medication 
compliance and effectiveness, and deliver or coordinate behavioral 
health services. HHS seeks comment on the principles by which the 
Secretary would determine which new medications would qualify.
    (3) Practitioner Training for 200 Patient Limit--HHS is seeking 
specific comment related to the level of training necessary to request 
a patient limit increase to 200 patients outside of a qualified 
practice setting. Specifically, under the current rule for the patient 
limit of 30 and 100, the training requirement may be satisfied at the 
time of initial NOI through a number of pathways, but the most common 
ways are via a subspecialty board certification in addiction psychiatry 
or addiction medicine, an addiction certification from ASAM, or 
completion of an 8-hour training provided by an approved organization. 
In this NPRM, SAMHSA would require board certification in addiction 
psychiatry or addiction medicine, but would not require additional 
training to progress to the 200-patient limit. However, this means that 
only practitioners with subspecialty board certifications will be 
eligible to apply for a patient waiver of 200 and practitioners 
satisfying training requirements via the other pathways for the 30 and 
100 patients will not be eligible. SAMHSA is seeking comment on whether 
the range of provider qualifications is too broad or too narrow to 
expand access to high quality medication-assisted treatment for opioid 
use disorder. If commenters assert that opportunity to qualify should 
be broadened, we also welcome recommendations regarding alternate 
pathways that would affirm competence without necessitating specialty 
board certification.
    (4) Alternate pathways to qualify for 200-patient prescribing 
limit--Under this proposal, only practitioners with current 100-patient 
waivers who are either board-certified in addiction medicine or 
addiction psychiatry or who practice in ``qualified practice settings'' 
or who request a temporary increase to treat up to 200 patients in 
order to address emergency situations may apply for the higher limit. 
HHS seeks comment on additional, alternate pathways by which a 
practitioner may become eligible to apply for a patient waiver of 200.
    (5) Process to request a patient limit of 200--HHS is seeking 
specific comment related to the requirements as defined in Sec.  
8.620(a) through (c). Specifically, how much cost will be associated 
with each requirement and what fraction of practitioners practicing in 
qualified practice settings will be able to fulfill such requirements.
    (6) Patient Volume Necessary--We are not aware of data that 
indicate what patient volume per practitioner is necessary in order to 
make the provision of buprenorphine to patients not cost prohibitive. 
We seek data on how many patients a physician would need to treat in 
order to make the training requirements, administrative requirements, 
and other requirements not cost prohibitive to the practitioner by type 
of clinical environment type (e.g., large group practice, small 
physician-owned practice, hospitals, Medicaid-accepting addiction 
treatment centers, etc.).
    (7) Frequency of Renewal Request for Patient Limit Increase to 200 
Patients--Currently, to be able to prescribe/dispense buprenorphine for 
the maintenance or detoxification of opioid use disorder, qualified 
practitioners must file a NOI with SAMHSA. Under this proposal, 
qualified practitioners in good standing with a current waiver to 
dispense to up to 100 patients may file a Request for Patient Limit 
Increase to treat up to 200 patients for a term of 3 years. SAMHSA is 
seeking comment on whether requiring the renewal for qualified 
practitioners seeking to treat up to 200 patients every 3 years is 
sufficient or whether practitioners should renew the waiver every year 
or every 2 years, instead of every 3 years.
    (8) Synchronization of Renewal Request with DEA Practitioner 
Registration Renewal--We seek comment on whether SAMHSA should 
synchronize the 3-year Request for Patient Limit Increase renewal with 
the renewal of the DEA practitioner registration to reduce practitioner 
burden.
    (9) Estimation of the Time Required to Seek Approval to Treat up to 
200 Patients --As stated in the Regulatory Impact Analysis, SAMHSA is 
seeking comment on the assumptions regarding the time required to 
complete the request for the higher patient limit.
    (10) Estimation of the Change in Practitioner Behavior--As stated 
in the Regulatory Impact Analysis, SAMHSA does not have information to 
estimate the number of practitioners who would change behavior in 
response to this proposed rule. SAMHSA is seeking comment on the 
estimation of the number of practitioners who are not currently 
eligible to submit a Request for Patient Limit Increase to treat up to 
200 patients but as a result of the proposed rule would take steps, 
such as obtain subspecialty board certification, or change practice 
settings, in order to qualify to treat up to 200 patients.
    (11) Estimation of the Number of Practitioners who are Eligible to 
Submit a Request for Patient Limit Increase to Treat up to 200 
Patients--As stated in the Regulatory Impact Analysis, SAMHSA seeks 
comment on an estimation of the number of practitioners who, based on 
the proposed rule, would be eligible to submit a Request for Patient 
Limit Increase to treat up to 200 patients, and, as a result of the 
proposed rule, would do so.
    (12) Estimation of the Number of People who will Receive MAT with 
Buprenorphine--As stated in the Regulatory Impact Analysis, SAMHSA 
seeks comment in order to refine the estimation of the number of people 
who will receive MAT with buprenorphine as a result of the proposed 
rule.
    (13) Reporting Periods--SAMHSA seeks comment on whether the 
reporting periods and deadline could be combined with other, existing 
reporting requirements in a way that would make

[[Page 17659]]

reporting less burdensome for practitioners.
    (14) Balance of Access and Safety--SAMHSA seeks comment on whether 
the proposed rule appropriately strikes the balance between ensuring 
that the credentials needed to prescribe MAT are within reach for 
interested practitioners, programs are practical to implement, and 
reporting requirements are not perceived as a barrier to participation.

List of Subjects in 42 CFR Part 8

    Health professions, Methadone, Reporting and recordkeeping 
requirements.

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

PART 8--MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS

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

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

0
2. Revise the heading of part 8 as set forth above.
0
3. Amend part 8 as follows:
0
a. Remove the word ``opiate'' and add the word ``opioid'' in its place 
wherever it appears; and
0
b. Remove the phrases ``opioid addiction'' and ``Opioid addiction'' and 
add their places the phrases ``opioid use disorder'' and ``Opioid use 
disorder'', respectively, wherever they appear.
0
4. Redesignate subpart C, consisting of Sec. Sec.  8.21 through 8.34, 
as subpart D and revise the heading as follows:

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

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

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

0
6. Add subpart B, redesignate Sec. Sec.  8.3, 8.4, 8.5, and 8.6 to the 
new subpart B, and revise the heading to read as follows:

Subpart B--Accreditation of Opioid Treatment Programs

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

Subpart A--General Provisions

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


Sec.  8.1  Scope.

    (a) Subparts A through C of this part establish the procedures by 
which the Secretary of Health and Human Services (the Secretary) will 
determine whether a practitioner is qualified under section 303(g) of 
the Controlled Substances Act (CSA) (21 U.S.C. 823(g)) to dispense 
opioid drugs in the treatment of opioid use disorders. The regulations 
also establish the Secretary's standards regarding the appropriate 
quantities of opioid drugs that may be provided for unsupervised use by 
individuals undergoing such treatment (21 U.S.C. 823(g)(1)). Under 
these regulations, a practitioner who intends to dispense opioid drugs 
in the treatment of opioid use disorder must first obtain from the 
Secretary or, by delegation, from the Administrator, Substance Abuse 
and Mental Health Services Administration (SAMHSA), a certification 
that the practitioner is qualified under the Secretary's standards and 
will comply with such standards. Eligibility for certification will 
depend upon the practitioner obtaining accreditation from an 
accreditation body that has been approved by SAMHSA. These regulations 
establish the procedures whereby an entity can apply to become an 
approved accreditation body. This part also establishes requirements 
and general standards for accreditation bodies to ensure that 
practitioners are consistently evaluated for compliance with the 
Secretary's standards for treatment of opioid use disorder with an 
opioid agonist treatment medication.
    (b) The regulations in subpart F of this part establish the 
procedures and requirements that practitioners who are authorized to 
treat up to 100 patients pursuant to a waiver obtained under section 
303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy in order to 
treat up to 200 patients with medications covered under section 
303(g)(2)(C) of the CSA.
0
9. Amend Sec.  8.2 as follows:
0
a. Revise the definitions of ``Accreditation body'' and ``Accreditation 
body application'';
0
b. Add, in alphabetical order, the definitions of ``Approval term'', 
``Behavioral health services'', and ``Board certification'';
0
c. Revise the definition of ``Certification'';
0
d. Add, in alphabetical order, the definitions of ``Covered 
medications'', ``Dispense'', ``Diversion control plan'', and 
``Emergency situation'';
0
e. Revise the definition of ``Interim maintenance treatment'';
0
f. Add, in alphabetical order, the definition of ``Nationally 
recognized evidence-based guidelines'';
0
g. Add, in alphabetical order, the definition of ``Opioid dependence'';
0
h. Remove the definition of ``Opioid treatment'';
0
i. Revise the definitions of ``Opioid treatment program'' and ``Opioid 
use disorder'';
0
j. Add, in alphabetical order, the definition of ``Opioid use disorder 
treatment'';
0
k. Revise the definition of ``Patient'';
0
l. Add, in alphabetical order, the definitions of ``Patient limit'' and 
``Practitioner incapacity'';
0
m. Remove the definition of ``Registered opioid treatment program''; 
and
0
n. Add, in alphabetical order, the definition of ``Waivered 
practitioner''.
    The revisions and additions read as follows:


Sec.  8.2  Definitions.

* * * * *
    Accreditation body means a body that has been approved by SAMHSA in 
this part to accredit opioid treatment programs using opioid agonist 
treatment medications.
    Accreditation body application means the application filed with 
SAMHSA for purposes of obtaining approval as an accreditation body.
* * * * *
    Approval term means the 3 year period in which a practitioner is 
approved to treat up to 200 patients that commences when a 
practitioner's Request for Patient Limit Increase is approved in 
accordance with Sec.  8.625.
    Behavioral health services means any non-pharmacological 
intervention carried out in a therapeutic context at an individual, 
family, or group level. Interventions may include structured, 
professionally administered interventions (e.g., cognitive behavior 
therapy or insight oriented psychotherapy) delivered in person, 
remotely via telemedicine shown in clinical trials to facilitate MAT 
outcomes or non-professional interventions.
    Board certification in addiction medicine or psychiatry means the 
receipt of board certification in a particular addiction medicine or 
psychiatry specialty and/or subspecialty of medical practice (e.g., 
subspecialty board certification in addiction medicine or psychiatry) 
from the American Board of Medical Specialties, a subspecialty board 
certification in addiction medicine from the American Osteopathic 
Association (AOA) or American Board of Addiction Medicine (ABAM), or an 
addiction certification from the American Society of Addiction Medicine 
(ASAM).

[[Page 17660]]

    Certification means the process by which SAMHSA determines that an 
opioid treatment program is qualified to provide opioid treatment under 
the Federal opioid treatment standards described in Sec.  8.12.
* * * * *
    Covered medications means the drugs or combinations of drugs that 
are covered under 21 U.S.C. 823(g)(2)(C).
* * * * *
    Dispense means to deliver a controlled substance to an ultimate 
user by, or pursuant to the lawful order of, a practitioner, including 
the prescribing and administering of a controlled substance.
    Diversion control plan means a set of documented procedures that 
reduce the possibility that controlled substances will be transferred 
or used illicitly.
    Emergency situation means that an existing State, Tribal, or local 
system for substance use disorder services is overwhelmed or unable to 
meet the existing need for medication-assisted treatment as a direct 
consequence of a clear precipitating event. This precipitating event 
must have an abrupt onset such as practitioner incapacity, natural or 
human-caused disaster; an outbreak associated with drug use; and result 
in significant death, injury, exposure to life-threatening 
circumstances, hardship, suffering, loss of property, or loss of 
community infrastructure
* * * * *
    Interim maintenance treatment means maintenance treatment provided 
in an opioid treatment program in conjunction with appropriate medical 
services while a patient is awaiting transfer to a program that 
provides comprehensive maintenance treatment.
* * * * *
    Nationally recognized evidence-based guidelines means a document 
produced by a national or international medical professional 
association, public health agency, such as the World Health 
Organization, or governmental body with the aim of assuring the 
appropriate use of evidence to guide individual diagnostic and 
therapeutic clinical decisions.
* * * * *
    Opioid dependence means repeated self-administration that usually 
results in opioid tolerance, withdrawal symptoms, and compulsive drug-
taking. Dependence may occur with or without the physiological symptoms 
of tolerance and withdrawal.
* * * * *
    Opioid treatment program or ``OTP'' means a program or practitioner 
engaged in opioid treatment of individuals with an opioid agonist 
treatment medication registered under 21 U.S.C. 823(g)(1).
    Opioid use disorder means a cluster of cognitive, behavioral, and 
physiological symptoms in which the individual continues use of opioids 
despite significant opioid-induced problems.
    Opioid use disorder treatment means the dispensing of an opioid 
agonist treatment medication, along with a comprehensive range of 
medical and rehabilitative services, when clinically necessary, to an 
individual to alleviate the adverse medical, psychological, or physical 
effects incident to an opioid use disorder. This term includes a range 
of services including detoxification treatment, short-term 
detoxification treatment, long-term detoxification treatment, 
maintenance treatment, comprehensive maintenance treatment, and interim 
maintenance treatment.
    Patient means any individual who receives MAT from a practitioner 
or program subject to this part.
    Patient limit means the maximum number of individual patients a 
practitioner may treat at any one time using covered medications.
    Practitioner incapacity means the inability of a waivered 
practitioner as a result of an involuntary event to physically or 
mentally perform the tasks and duties required to provide medication-
assisted treatment in accordance with nationally recognized evidence-
based guidelines.
* * * * *
    Waivered practitioner means a physician who is appropriately 
licensed by the State to dispense covered medications and who possesses 
a waiver under 21 U.S.C. 823(g)(2).
0
10. Amend Sec.  8.3 by revising the introductory text of paragraph (b) 
to read as follows:


Sec.  8.3  Application for approval as an accreditation body.

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

Subpart E [Reserved]

0
11. Reserve subpart E.
0
12. Add subpart F, consisting of Sec. Sec.  8.610 through 8.655, to 
read as follows:
Subpart F--Authorization to Increase Patient Limit to 200 Patients
Sec.
8.610 Which practitioners are eligible for a patient limit of 200?
8.615 What constitutes a qualified practice setting?
8.620 What is the process to request a patient limit of 200?
8.625 How will a Request for Patient Limit Increase be processed?
8.630 What must practitioners do in order to maintain their approval 
to treat up to 200 patients?
8.635 What are the reporting requirements for practitioners whose 
Request for Patient Limit Increase is approved?
8.640 What is the process for renewing a practitioner's Request for 
Patient Limit Increase approval?
8.645 What are the responsibilities of practitioners who do not 
submit a renewal Request for Patient Limit Increase, or whose 
request is denied?
8.650 Can SAMHSA's approval of a practitioner's Request for Patient 
Limit Increase be suspended or revoked?
8.655 Can a practitioner request to temporarily treat up to 200 
patients in emergency situations?

Subpart F--Authorization to Increase Patient Limit to 200 Patients


Sec.  8.610  Which practitioners are eligible for a patient limit of 
200?

    A practitioner is eligible for a patient limit of 200 if:
    (a) The practitioner possesses a current waiver to treat up to 100 
patients under section 303(g)(2) of the Controlled Substances Act (21 
U.S.C. 823(g)(2)) and has maintained the waiver in accordance with 
applicable statutory requirements without interruption for at least one 
year since the practitioner's notification of intent (NOI) under 
section 303(g)(2)(B) to treat up to 100 patients was approved;
    (b) The practitioner:
    (1) Holds a subspecialty board certification in addiction 
psychiatry or addiction medicine; or
    (2) Provides MAT utilizing covered medications in a qualified 
practice setting as defined in Sec.  8.615;
    (c) The practitioner has not had his or her enrollment and billing 
privileges in the Medicare program revoked under Sec.  424.535 of this 
title; and
    (d) The practitioner has not been found to have violated the 
Controlled Substances Act pursuant to 21 U.S.C. 824(a).


Sec.  8.615  What constitutes a qualified practice setting?

    A qualified practice setting is a practice setting which:
    (a) Provides professional coverage for patient medical emergencies 
during hours when the practitioner's practice is closed;

[[Page 17661]]

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


Sec.  8.620  What is the process to request a patient limit of 200?

    In order for a practitioner to receive approval for a patient limit 
of 200, a practitioner must meet all of the requirements specified in 
Sec.  8.610 and submit a Request for Patient Limit Increase to SAMHSA 
that includes all of the following:
    (a) Completed Request for Patient Limit Increase form;
    (b) Statement certifying that the practitioner:
    (1) Will adhere to nationally recognized evidence-based guidelines 
for the treatment of patients with opioid use disorders;
    (2) Will provide patients with necessary behavioral health services 
as defined in Sec.  8.2 or through an established formal agreement with 
another entity to provide behavioral health services;
    (3) Will provide appropriate releases of information, in accordance 
with Federal and State laws and regulations, including the Health 
Information Portability and Accountability Act Privacy Rule and part 2 
of this chapter, if applicable, to permit the coordination of care with 
behavioral health, medical, and other service practitioners;
    (4) Will use patient data to inform the improvement of outcomes;
    (5) Will adhere to a diversion control plan to manage the covered 
medications and reduce the possibility of diversion of covered 
medications from legitimate treatment use;
    (6) Has considered how to assure continuous access to care in the 
event of practitioner incapacity or an emergency situation that would 
impact a patient's access to care as defined in Sec.  8.2; and
    (7) Will notify all patients above the 100 patient level, in the 
event that the request for the higher patient limit is not renewed or 
is denied, that the practitioner will no longer be able to provide MAT 
services using buprenorphine to them and make every effort to transfer 
patients to other addiction treatment;
    (c) Any additional documentation to demonstrate compliance with 
Sec.  8.610 as requested by SAMHSA.


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

    (a) Not later than 45 days after the date on which SAMHSA receives 
a practitioner's Request for Patient Limit Increase as described in 
Sec.  8.620, or renewal Request for Patient Limit Increase as described 
in Sec.  8.640, SAMHSA shall approve or deny the request.
    (1) A practitioner's Request for Patient Limit Increase will be 
approved if the practitioner satisfies all applicable requirements 
under Sec. Sec.  8.610 and 8.620. SAMHSA will thereafter notify the 
practitioner who requested the patient limit increase, and the Drug 
Enforcement Administration (DEA), that the practitioner has been 
approved to treat up to 200 patients using covered medications. A 
practitioner's approval to treat up to 200 patients under this section 
will extend for a term not to exceed 3 years.
    (2) SAMHSA may deny a practitioner's Request for Patient Limit 
Increase if SAMHSA determines that:
    (i) The Request for Patient Limit Increase is deficient in any 
respect; or
    (ii) The practitioner has knowingly submitted false statements or 
made misrepresentations of fact in the practitioner's Request for 
Patient Limit Increase.
    (b) If SAMHSA denies a practitioner's Request for Patient Limit 
Increase (or renewal), SAMHSA shall notify the practitioner of the 
reasons for the denial.
    (c) If SAMHSA denies a practitioner's Request for Patient Limit 
Increase (or renewal) based solely on deficiencies that can be 
resolved, and the deficiencies are resolved to the satisfaction of 
SAMHSA in a manner and time period approved by SAMHSA, the 
practitioner's Request for Patient Limit Increase will be approved. If 
the deficiencies have not been resolved to the satisfaction of SAMHSA 
within the designated time period, the Request for Patient Limit 
Increase will be denied.


Sec.  8.630  What must practitioners do in order to maintain their 
approval to treat up to 200 patients?

    (a) A practitioner whose Request for Patient Limit Increase is 
approved in accordance with Sec.  8.625 shall maintain all eligibility 
requirements specified in Sec.  8.610, and all attestations made in 
accordance with Sec.  8.620(b), during the practitioner's 3-year 
approval term. Failure to do so may result in SAMHSA withdrawing its 
approval of a practitioner's Request for Patient Limit Increase.
    (b) All practitioners whose Request for Patient Limit Increase has 
been approved under Sec.  8.625 must provide reports to SAMHSA as 
specified in Sec.  8.635.


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

    (a) All practitioners whose Request for Patient Limit Increase is 
approved under Sec.  8.625 must submit reports to SAMHSA, along with 
documentation and data, as requested by SAMHSA, to demonstrate 
compliance with Sec.  8.620, applicable eligibility requirements 
specified in Sec.  8.610, and all attestation requirements in Sec.  
8.620(b).
    (b) Reporting requirements may include a request for information 
regarding:
    (1) The average monthly caseload of patients receiving 
buprenorphine-based MAT, per year.
    (2) Percentage of active buprenorphine patients (patients in 
treatment as of reporting date) that received psychosocial or case 
management services (either by direct provision or by referral) in the 
past year due to:
    (i) Treatment initiation.
    (ii) Change in clinical status.
    (3) Percentage of patients who had a prescription drug monitoring 
program query in the past month; and
    (4) Number of patients at the end of the reporting year who:
    (i) Have completed an appropriate course of treatment with 
buprenorphine in order for the patient to achieve and sustain recovery.
    (ii) Are not being seen by the provider due to referral by the 
provider to a more or less intensive level of care.

[[Page 17662]]

    (iii) No longer desire to continue use of buprenorphine.
    (iv) Are no longer receiving buprenorphine for reasons other than 
paragraph (b)(4)(i) through (iii) of this section.
    (c) The report must be submitted within twelve months after the 
date that a practitioner's Request for Patient Limit Increase is 
approved under Sec.  8.625, and annually thereafter.
    (d) SAMHSA may check reports from practitioners prescribing under 
the higher patient limit against other existing data sources, such as 
PDMPs. If discrepancies between reported information and other existing 
data are identified, SAMHSA may require additional documentation from 
practitioners whose reports are identified as including these 
discrepancies.
    (e) Failure to submit reports under this section, or deficient 
reports, may be deemed a failure to satisfy the requirements for a 
patient limit increase, and may result in the withdrawal of SAMHSA's 
approval of the practitioner's Request for Patient Limit Increase.


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

    (a) Practitioners who intend to continue to treat up to 200 
patients beyond their current 3 year approval term must submit a 
renewal Request for Patient Limit Increase in accordance with the 
procedures outlined under Sec.  8.620 at least 90 days before the 
expiration of their approval term.
    (b) If SAMHSA does not reach a final decision on a renewal Request 
for Patient Limit Increase before the expiration of a practitioner's 
approval term, the practitioner's existing approval term will be deemed 
extended until SAMHSA reaches a final decision.


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

    Practitioners who are approved to treat up to 200 patients in 
accordance with Sec.  8.625, but who do not renew their Request for 
Patient Limit Increase, or whose request is denied, shall notify, under 
Sec.  8.620(b)(7) in a time period specified by SAMHSA, all patients 
affected above the 100 patient limit, that the practitioner will no 
longer be able to provide MAT services using covered medications and 
make every effort to transfer patients to other addiction treatment.


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

    (a) Suspension. SAMHSA may suspend its approval of a practitioner's 
Request for Patient Limit Increase under Sec.  8.625 if it has reason 
to believe that immediate action is necessary to protect public health 
or safety.
    (b) Revocation. SAMHSA may revoke its approval of a practitioner's 
Request for Patient Limit Increase under Sec.  8.625 at any time during 
the 3 year approval term if SAMHSA determines that the practitioner 
made any misrepresentations in the practitioner's Request for Patient 
Limit Increase, or if SAMHSA determines that the practitioner no longer 
satisfies the requirements of this subpart, or has been found to have 
violated the CSA pursuant to 21 U.S.C. 824(a).


Sec.  8.655  Can a practitioner request to temporarily treat up to 200 
patients in emergency situations?

    (a) Practitioners with a current waiver to prescribe up to 100 
patients and who are not otherwise eligible to treat up to 200 patients 
under Sec.  8.610 may request a temporary increase to treat up to 200 
patients in order to address emergency situations as defined in Sec.  
8.2 if the practitioner provides information and documentation that:
    (1) Describes the emergency situation in sufficient detail so as to 
allow a determination to be made regarding whether the situation 
qualifies as an emergency situation as defined in Sec.  8.2, and that 
provides a justification for an immediate increase in that 
practitioner's patient limit;
    (2) Identifies a period of time, not longer than 6 months, in which 
the higher patient limit should apply, and provides a rationale for the 
period of time requested; and
    (3) Describes an explicit and feasible plan to meet the public and 
individual health needs of the impacted persons once the practitioner's 
approval to treat up to 200 patients expires.
    (b) Prior to taking action on a practitioner's request under this 
section, SAMHSA shall consult, to the extent practicable, with the 
appropriate governmental authority in order to determine whether the 
emergency situation that a practitioner describes justifies an 
immediate increase in the higher patient limit.
    (c) If SAMHSA determines that a practitioner's request under this 
section should be granted, SAMHSA will notify the practitioner that his 
or her request has been approved. The period of such approval shall not 
exceed six months.
    (d) If a practitioner wishes to receive an extension of the 
approval period granted under this section, he or she must submit a 
request to SAMHSA at least 30 days before the expiration of the six 
month period, and certify that the emergency situation as defined in 
Sec.  8.2 necessitating an increased patient limit continues. Prior to 
taking action on a practitioner's extension request under this section, 
SAMHSA shall consult, to the extent practicable, with the appropriate 
governmental authority in order to determine whether the emergency 
situation that a practitioner describes justifies an extension of an 
increase in the higher patient limit.
    (e) Except as provided in this section and Sec.  8.650, 
requirements in other sections under subpart F of this part do not 
apply to practitioners receiving waivers in this section.

    Dated: March 23, 2016.
Kana Enomoto,
Principal Deputy Administrator, Substance Abuse and Mental Health 
Services Administration.
    Approved: March 24, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-07128 Filed 3-29-16; 8:45 am]
BILLING CODE 4162-20-P