Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Proposed Modification of Dispensing Restrictions for Buprenorphine and Buprenorphine Combination as Used in Approved Opioid Treatment Medications, 72752-72761 [2012-29417]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Rules and Regulations]
[Pages 72752-72761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 8

RIN 0930-AA14


Opioid Drugs in Maintenance and Detoxification Treatment of 
Opiate Addiction; Proposed Modification of Dispensing Restrictions for 
Buprenorphine and Buprenorphine Combination as Used in Approved Opioid 
Treatment Medications

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

ACTION: Final rule.

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SUMMARY: This final rule amends the federal opioid treatment program 
regulations by modifying the dispensing requirements for buprenorphine 
and buprenorphine combination products approved by the Food and Drug 
Administration (FDA) for opioid dependence and used in federally 
certified and registered opioid treatment programs. In particular, this 
rule would allow opioid treatment programs more flexibility in 
dispensing take-home supplies of buprenorphine--removing restrictions 
on the time a patient needs to be in treatment in order to receive 
take-home supplies--after the assessment and documentation of a 
patient's responsibility and stability to receive opioid addiction 
treatment medication. Opioid treatment programs that use these products 
in the treatment of opioid dependence will continue to adhere to all 
other federal treatment standards established for methadone.

DATES: This rule is effective January 7, 2013.

FOR FURTHER INFORMATION CONTACT: Nicholas Reuter, Center for Substance 
Abuse Treatment (CSAT), Division of Pharmacologic Therapies, SAMHSA, 1 
Choke Cherry Road, Room 2-1063, Rockville, MD 20857, (240) 276-2716, 
email: Nicholas.Reuter@samhsa.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Purpose of the Regulatory Action

    This final rule will modify the way that the narcotic treatment 
medication buprenorphine will be dispensed by treatment programs to 
individuals who are dependent on heroin or on certain prescription pain 
relievers by reducing

[[Page 72753]]

the requirements for dispensing treatment medications for ``take home'' 
use. Currently, patients in treatment must wait one year before 
treatment programs may dispense a two week supply of medication. These 
types of requirements impart a burden on patients and may affect their 
adherence to treatment. This final rule will provide flexibility to 
programs in matching patient needs.
    There are approximately 1,270 facilities in the U.S. that are 
specially authorized to use narcotic medications like methadone and 
buprenorphine to treat addiction. The special authorization is required 
under federal law because these medications can be abused, and can also 
produce dependence. To obtain the special authorization, the programs 
must adhere to requirements that relate to the way patients are 
selected for treatment, how they receive treatment, and how the 
treatment medications are dispensed. The Secretary has the authority 
under 21 U.S.C, 823(g) to establish standards for the quantity of 
narcotic treatment medications, like buprenorphine, that may be 
provided by authorized programs for unsupervised use. This rulemaking 
changes these regulatory standards for buprenorphine.

B. Summary of the Major Provisions of the Regulatory Action in Question

    This final rule changes the way one narcotic treatment medication, 
buprenorphine, is dispensed to patients in admitted to Opioid Treatment 
Programs (OTPs). The rule permits OTPs to dispense buprenorphine 
addiction treatment products to patients without requiring the patients 
to meet eligibility requirements relating to their length of treatment. 
This change will increase flexibility in treatment and is justified by 
the experience to date with buprenorphine addiction treatment products, 
together with buprenorphine's safety profile.

C. Costs and Benefits

    The Secretary anticipates that there will be an overall reduction 
in societal costs if treatment is expanded under this final rule. The 
costs for OTPs to implement this regulatory change are negligible. The 
added flexibility will permit OTPs to dispense buprenorphine products 
more frequently. Insofar as there are costs associated with each 
dispensing activity, this change could lead to lower overall treatment 
costs for OTPs. The added flexibility will also benefit patients, who 
should be able to report to the OTP less frequently, while still 
benefitting from the counseling, medical, recovery and other services 
OTPs provide. There may be additional diversion and abuse risks 
associated with the possible of expansion of treatment, but the 
Secretary believes that the benefits of increased flexibility and 
increased access to care in OTP settings outweighs these possible 
risks.

II. Background

    Opioid Treatment Regulations--The opioid treatment program 
regulations (42 CFR part 8) establish the procedures by which the 
Secretary will determine whether a practitioner is qualified under 
Section 303(g) of the Controlled Substance Act (CSA) (21 U.S.C. 
823(g)(1)) to dispense certain therapeutic narcotic drugs in the 
treatment of individuals suffering from narcotic addiction. These 
regulations also establish the Secretary's standards regarding the 
appropriate quantities of narcotic drugs that may be provided for 
unsupervised use by individuals undergoing such treatment (21 U.S.C. 
823(g)(1)(c)) (See also 42 U.S.C. 290bb-2a.).
    In a notice published in the Federal Register on January 17, 2001 
(66 FR 4076, January 17, 2001), SAMHSA issued final regulations for the 
use of narcotic drugs in maintenance and detoxification treatment of 
opioid addiction. That final rule established an accreditation-based 
regulatory system under 42 CFR part 8 (``Certification of Opioid 
Treatment Programs (OTPs)''). The regulations also established (under 
Sec.  8.12) the Secretary's standards for the use of opioid medications 
in the treatment of addiction, including standards regarding the 
quantities of opioid drugs which may be provided for unsupervised use. 
The SAMHSA regulations establish the standards for determining that 
practitioners (programs) are qualified for Drug Enforcement 
Administration (DEA) registration under 21 U.S.C. 823(g)(1). The 
authority citation for this rule is 21 U.S.C. 823; 42 U.S.C. 290bb-2a, 
290aa(d), 290 dd-2, 300x-23, 300x-27(a), 300y-11.
    Section 8.12(h) sets forth the standards for medication 
administration, dispensing and use. Under this Section, OTPs shall use 
only those opioid agonist treatment medications that are approved by 
the FDA under section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) for use in the treatment of opioid addiction. The 
regulation listed methadone and levomethadyl acetate (``ORLAAM'') as 
the opioid agonist treatment medications considered to be approved by 
the FDA for use in the treatment of opioid addiction.
    A. Interim Final Rule--SAMHSA expanded the list of approved 
medications for use in certified opioid treatment programs by issuing 
an Interim Final Rule on May 22, 2003 (68 FR 27937, May 22, 2003, 
``Interim Final Rule''). This notice was preceded by the FDA's approval 
of two buprenorphine products (Subutex[supreg] and Suboxone[supreg]) on 
October 8, 2002, and the DEA's rescheduling of bulk buprenorphine, as 
well as all approved medical products containing buprenorphine from 
Schedule V to Schedule III (see Federal Register of October 7, 2002 (67 
FR 62354)).
    The May 22, 2003, Interim Final Rule added the two FDA-approved 
buprenorphine addiction treatment products to the previous list of 
approved opioid treatment medications under 42 CFR 8.12 (h)(2). 
Effective upon publication, the Interim Final Rule allowed OTPs to use 
buprenorphine and buprenorphine combination products for the treatment 
of opioid addiction. In addition, the Interim Final Rule required OTPs 
to apply the same treatment standards that were finalized on January 
17, 2001, for methadone and ORLAAM. These requirements included the 
restrictions for treatment medications dispensed for unsupervised use, 
e.g., ``take-home'' medication. Finally, the Interim Final Rule 
solicited comments on the new provisions.
    The ``take-home'' provisions are intended to reduce the risk of 
abuse and diversion of opioid treatment medications that have abuse 
potential. The rules tie the amount of ``take home'' medication that a 
program may dispense to patient characteristics, such as their 
stability, responsibility and time in treatment. For example, under 42 
CFR 8.12(i)(3), a patient would have to be stable in treatment for 9 
months to be eligible for a 6-day supply of medication (either 
methadone or buprenorphine). In addition to the time in treatment 
eligibility, program physicians must also evaluate and document every 
patient's stability for take-home medication by applying the factors 
set forth under 42 CFR 8.12(i)(2).
    B. Buprenorphine in Office-Based Opioid Treatment--The Drug 
Addiction Treatment Act of 2000, (Section 3502 of the Children's Health 
Act of 2000, Pub. L. 106-310, 21 U.S.C. Sec.  823(g)(2)), ``DATA 
2000'') permits qualified physicians to dispense certain opioid 
treatment medications for the treatment of opioid dependence. Under 
DATA 2000, qualifying physicians are ``certified'' to obtain waivers 
from the requirement under 21 U.S.C. 823(g) to obtain approval from 
SAMHSA as OTPs. Qualifying physicians are

[[Page 72754]]

permitted to dispense, including prescribe, Schedule III, IV, and V 
narcotic controlled drugs approved by the FDA specifically for 
maintenance or detoxification treatment without being separately 
registered as a narcotic treatment program by DEA (21 U.S.C. 
823(g)(2)(A)). ``DATA Waived'' physicians are not permitted to 
prescribe the Schedule II medication methadone for addiction or 
dependence treatment.
    Certified physicians are subject to certain limits. For example, 
certified physicians are authorized to prescribe only opioid 
medications that are specifically approved by FDA for dependence or 
addiction treatment. These medications must be controlled in Schedules 
III through V. This authorization excludes the Schedule II medication 
methadone. Physicians must be ``qualified'' by credentialing or 
experience. In addition, physicians are subject to limits on how many 
patients they can treat at any one time. DATA 2000 did not include 
restrictions on the amount of an approved drug that may be prescribed 
to a patient at any one time.
    DATA 2000 assigned new responsibilities to both the HHS and the 
Department of Justice (DOJ). The DEA issued regulations to carry out 
the DOJ responsibilities, while HHS delegated implementation 
responsibilities to SAMHSA. SAMHSA has implemented the Department's new 
responsibilities without new rules. SAMHSA developed a system to 
accept, review, and verify that physicians fulfill the criteria under 
DATA to qualify for the waiver. The system assures that physicians 
complete qualifying training, that they have the necessary DEA 
registration, and that they are licensed. In addition, SAMHSA developed 
and issued an office-based treatment guideline, which was a requirement 
under DATA 2000. The DEA's final regulation removed the regulatory 
prohibition on prescribing certain narcotic treatment drugs, outlined 
the process for the interagency review of ``notifications'' under the 
new law and how the ``unique identification number'' will be assigned, 
and established recordkeeping requirements for certified physicians. 
The DEA rule did not establish new requirements or limits for 
dispensing or prescribing buprenorphine products (70 FR 36338, June 23, 
2005).
    DEA, FDA and SAMHSA actions to implement DATA 2000 and SAMHSA's May 
22, 2003, Interim Final Rule distinguished how the same medications 
(buprenorphine and buprenorphine combination products) are dispensed in 
different settings (OTP versus certified physicians). This distinction 
is because, as explained elsewhere in this notice, OTPs are registered 
under 21 U.S.C. Section 823(g)(1) of the CSA as practitioner programs. 
Under this section, SAMHSA certifies and DEA registers ``narcotic 
treatment programs'' (not individual physicians) to dispense and 
administer (but not prescribe) approved opioid treatment medications 
for dependence or addiction treatment. As certified and registered 
programs with required staffing (physicians, counselors, other health 
professionals), OTPs are subject to extensive federal, state, and local 
regulation, including accreditation. OTP medical staffs are required to 
be licensed and qualified; however, there is no requirement that the 
OTP physicians, who are part of the treatment team, complete special 
training on methadone or buprenorphine treatment, or obtain waivers 
under DATA 2000. As noted elsewhere in this notice, even though it is 
not required that OTP program physicians obtain waivers to prescribe 
buprenorphine products, most OTP physicians have completed the training 
and obtained the waivers. The minority of physicians in OTPs who have 
not obtained waivers may be located in programs that currently do not 
use buprenorphine products. Unlike DATA-waivered physicians, federal 
law does not place a limit on how many patients OTPs treat with 
buprenorphine or methadone.
    C. Comments Submitted in Response to Interim Final Rule--In 
response to the Interim Final Rule, SAMHSA received two comments from 
individuals representing hundreds of OTPs providing treatment in 
several states. While the comments support the Secretary's immediate 
action to make the new treatment medication available to OTPs 
expeditiously, the comments questioned the rationale for applying the 
treatment standards in place for methadone to the new buprenorphine 
products. One commenter noted that buprenorphine has the same 
pharmacological properties whether administered by OTPs or ``waived 
physicians.''
    The commenter did not believe that the regulations should preclude 
OTPs from dispensing buprenorphine in the same manner as private 
physicians. They stated that it was an error to impose uniquely 
stringent treatment standards on those clinics best placed to 
administer buprenorphine products to treat addiction. Because of these 
dispensing restrictions, the commenter believed that the interim final 
rule ``in short, will significantly limit if not completely suppress 
the availability of buprenorphine therapy in OTPs.''
    The comments also suggested that the restriction would impact 
patient care and noted that whether used in an OTP or in a private 
office, buprenorphine therapy should not be subject to the dispensing 
restrictions developed to deal with the special risks posed by Schedule 
II methadone. Commenters noted that from the patient's perspective, the 
critical advantage of buprenorphine is the possibility of avoiding the 
long-term daily attendance for dosing that is required with methadone 
therapy. The commenters stated that ``OTPs have substantial experience 
in treating a particularly challenging population of patients. 
Requiring Schedule II type procedures for OTP-based buprenorphine 
treatment-and by precluding OTPs from administering buprenorphine in 
the same manner that the drug is available to private physicians risks 
suppression of addicts entering treatment.''
    The commenters requested that SAMHSA provide OTPs with the same 
take-home prescribing authority which is currently in force for 
qualified physicians under DATA 2000 suggesting that in this way, there 
will be no artificial difference in how OTPs prescribe buprenorphine as 
compared to qualified physicians under DATA 2000. The comments did not 
suggest changing the OTP dispensing restriction for methadone.
    D. Notice of Proposed Rulemaking--After considering the comments 
submitted in response to the Interim Final Rule, along with 
administrative considerations, the Secretary decided to not finalize 
the Interim Final Rule. Instead, the Secretary published a Federal 
Register Notice of Proposed Rulemaking. In the June 19 2009, Notice (74 
FR 29153, June 19, 2009) the Secretary proposed to modify the 
dispensing regime for buprenorphine in OTPs. The proposed rule was 
based upon the information available that the experience with 
buprenorphine use in addiction treatment over the last several years, 
together with the pharmacological properties of the approved 
buprenorphine treatment products, distinguishes Schedule III 
buprenorphine products from Schedule II methadone products. Schedule II 
is the most restrictive Schedule under the Controlled Substances Act, 
reserved for substances with high potential for abuse and accepted 
medical use. Substances controlled in Schedule III have a lower 
potential for abuse compared to Schedule II substances. These 
distinctions supported the establishment of a less restrictive 
distribution scheme for Schedule III

[[Page 72755]]

buprenorphine products approved to treat opioid dependence.
    In the June 19 2009, Notice (74 FR 29153, June 19, 2009), SAMHSA 
did not propose to change any of the provisions in Subpart A 
(Accreditation) or Subpart C (Procedures for Review of Suspension or 
Proposed Revocation of OTP Certification and of Adverse Action 
Regarding Withdrawal of Approval of an Accreditation Body). Instead, 
SAMHSA proposed an amendment to Subpart B, Certification and Treatment 
Standards. SAMHSA proposed to amend only one Section of Subpart B, 
Section 8.12(i) regarding unsupervised or ``take-home'' use.
    Under 42 CFR 8.12(i), OTPs must adhere to requirements for 
dispensing treatment medications for unsupervised or ``take-home'' use. 
These restrictions are intended to limit or reduce the potential for 
diversion of these medications to the illicit market. The proposed rule 
would remove the restrictions for dispensing buprenorphine and 
buprenorphine combination products for unsupervised or ``take-home'' 
use while retaining those requirements for methadone products. The 
proposed change would be incorporated by adding the following language 
to 42 CFR 8.12(i)(3): ``The dispensing restrictions set forth in 
paragraphs (i) through (vi) do not apply to buprenorphine and 
buprenorphine products listed under 42 CFR section 8.12(h)(2)(iii).'' 
As discussed throughout this notice, the Secretary believes that 
buprenorphine's lower potential for abuse, and other factors, when 
compared to methadone, supports this change.
    It should be noted that OTPs would still be required to assess and 
document each patient's responsibility and stability to handle opioid 
drug products, including buprenorphine products for unsupervised use 
set forth under 42 CFR 8.12(i)(2) and 8.12(i)(3). In addition, the 
provisions of DATA 2000 that limit the total number of patients an 
office-based physician could treat would not be applied to patients 
treated with buprenorphine products in OTPs.
    In response to the June 19, 2009, proposed rule, the Secretary 
received 12 comments from patient advocacy groups, addiction treatment 
provider associations, addiction medicine treatment societies, state 
regulatory officials, and individuals not affiliated with any 
organizations. These comments have been considered and analyzed, as 
discussed below.
    E. Discussion, Analyses of Comments. Most comments generally 
supported the proposed changes to the dispensing restrictions for 
buprenorphine addiction treatment products in OTPs. A few comments 
opposed the change, while others either suggested changes to the OTP 
regulations, or changes to DATA 2000.
    1. Those comments that support the modification to the rules stated 
that the change would significantly increase the use of a valuable 
treatment medication (buprenorphine) for opioid dependence and 
addiction through OTPs. They also noted that the change would make the 
regulations more consistent with DATA 2000. Commenters noted, for 
example, that ``the analysis supplied by SAMHSA is very complete and 
accurately reflects the realities of the treatment experience of 
patients in both OTP's and addiction physicians' offices.'' They note 
that there is extensive patient experience, including the hundreds of 
thousands of patients who have received buprenorphine prescriptions 
from physicians authorized under DATA 2000, that supports the safety 
and efficacy of buprenorphine addiction treatment products dispensed 
for unsupervised use. Another comment stated that the proposed rule 
will help ease the financial and staffing burden incurred with the 
daily supervised administration of buprenorphine in OTPs. This change 
may allow OTPs to increase their patient capacity to match the 
community's needs. Other comments supported the change for its impact 
on patient access to treatment, particularly in rural settings.
    2. Another comment supporting the proposed change urged SAMHSA to 
go further to implement harm reduction measures, including expanded 
access to substitution treatment and distribution of sterile injection 
equipment. The comment is based upon studies that indicate a higher 
prevalence of intravenous heroin and prescription opioid abuse in 
patients enrolling in OTPs compared to patients seeking treatment in 
office-based settings. According to the comment, the increased risk of 
intravenous drug abuse would also be present in OTP patients who 
receive buprenorphine products (combination or single entity) for 
addiction treatment. The commenter was concerned that the hypothetical 
increase in intravenous buprenorphine abuse would lead to increases in 
infectious disease transmission and other health issues.
    As stated in the June 2009 NPRM, the Secretary anticipates that 
reducing the distribution restrictions for OTPs using buprenorphine 
products would increase the number of patients treated in OTPs, 
expanding access to medication assisted treatment. Although studies may 
show a higher prevalence of intravenous drug abuse among individuals 
entering OTPs compared to office-based physicians, it is not clear that 
these patients would continue intravenous abuse once in treatment, or 
if they would increase the level of intravenous buprenorphine abuse. 
Indeed, the number of patients treated with buprenorphine products in 
OTPs has increased steadily since 2003. According to the 2010 National 
Survey on Substance Abuse Treatment Services (N-SSATS, a point 
prevalence, one day client count estimate), OTPs reported treating 
almost 6,500 patients with buprenorphine products (REF 1). Although a 
modest number when compared to the hundreds of thousands of patients 
who receive buprenorphine products from office-based DATA 2000 
prescribers, it represents a 5-fold increase since 2005. The Secretary 
is not aware of a significant increase in intravenous buprenorphine 
abuse during this period. The Secretary will continue to monitor the 
treatment field to detect changes in rates of intravenous buprenorphine 
abuse.
    3. One commenter supported the proposal to eliminate the take home 
restrictions for buprenorphine in OTPs but urged SAMHSA to 
``harmonize'' the OTP use of buprenorphine with the requirements of 
DATA 2000, in particular, the patient limits. A different commenter, 
while supporting the proposed rule, suggested that the patient limit 
requirements of DATA 2000 be eliminated altogether. Finally, one 
comment supported the proposal, but stated that it did not go far 
enough. This commenter believed that the OTPs rules should be 
harmonized to eliminate all other requirements under 42 CFR part 8, so 
that there would be no differences in requirements for patients treated 
in OTP versus office-based DATA waived physicians.
    These comments refer to the requirements under DATA 2000 that 
physicians adhere to patient limits. Under DATA 2000, a physician 
initially is limited to treating no more than 30 patients at any one 
time. DATA 2000 was modified by public law in 2005 to permit physicians 
to submit applications to treat up to 100 patients at any one time. Of 
the almost 22,000 physicians certified to prescribe buprenorphine 
products under DATA 2000, almost 5,200 submitted notifications 
necessary to treat up to 100 patients.
    The Secretary does not intend to issue new rules to ``harmonize'' 
the use of buprenorphine in OTPs with the use of buprenorphine under 
DATA 2000 as the commenter suggests. The commenter is correct in noting 
that DATA 2000 physicians are subject to limits on how

[[Page 72756]]

many patients that they may treat with buprenorphine for addiction 
treatment at any one time, while OTPs are not subject to patient 
limits. It should be noted, however that under 42 CFR part 8, OTPs are 
required to provide counseling, medical, drug testing, and other 
services to each patient admitted to treatment. In addition, OTPs are 
subject to state laws and regulations, including, in some cases, 
patient limits. At this time, DATA waived physicians are not required 
under federal treatment regulations to provide counseling and other 
services to the patients they treat. The Secretary is not proposing to 
harmonize either the patient limits or the counseling and services 
requirements and will not be modifying patient limits in OTPs or for 
DATA Waived physicians at this time. In addition, the comment to remove 
most of the requirements set forth under 42 CFR part 8, for OTPs, goes 
well beyond the scope of changes proposed in the June 2009, NPRM. 
Additional changes to these regulations would need to be preceded by 
another notice and comment rulemaking process.
    4. One comment urged SAMHSA to address concerns about buprenorphine 
abuse and diversion from OTPs by ``working with the Drug Enforcement 
Administration and the Food and Drug Administration to develop a risk 
evaluation and mitigation strategy.'' The strategy would include dose 
and quantity limits for buprenorphine, and require that patient 
demonstrate stability for an unspecified period of time before they are 
provided buprenorphine products for unsupervised use.
    The Secretary notes that the FDA has established a Risk Evaluation 
and Mitigation Strategy (REMS) program for buprenorphine addiction 
treatment products.\1\ In addition, FDA has established a REMS program 
for certain buprenorphine pain treatment products. These programs 
include components on prescriber education to address prescribing 
practices (including guidance on dosing) and other measures to help 
ensure that only appropriate patients receive the drug. Making sure 
that only an appropriate group of patients use the product has the 
effect of reducing the abuse and diversion of buprenorphine addiction 
and pain treatment products. SAMHSA has worked with FDA to make the 
buprenorphine addiction treatment REMS program consistent with these 
rules. At this time, the Secretary does not believe that modifications 
to the REMS for buprenorphine addiction treatment products are 
necessary to ensure the benefits of the product outweigh the risks. In 
addition, the Secretary does not accept the recommendation that the 
regulations require OTP patients demonstrate stability for a period of 
time before receiving buprenorphine take homes. As discussed in the 
NPRM and throughout this final rule, the Secretary believes that there 
are adequate safeguards and controls in place to minimize buprenorphine 
abuse and diversion without applying the time in treatment requirements 
under 42 CFR 8.12. These include the requirements for patient stability 
assessments and criteria for stability set forth under 42 CFR 8.12 
(i)(2). Under this rule, OTPs will continue to be required to assess 
patients before unsupervised use and they will continue to be required 
to provide counseling, which is not required of office-based settings. 
Finally, as stated elsewhere in this notice, SAMHSA will send a formal 
guidance letter to all OTP Medical Directors, encouraging them to 
complete buprenorphine training and obtain a waiver. In the letter, 
SAMHSA will provide links to Web sites where OTP physicians can 
complete on-line qualifying training and will offer to send the OTP 
physicians a CD-ROM to complete training.
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    \1\ The Food and Drug Administration Amendments Act of 2007 gave 
FDA the authority to require a Risk Evaluation and Mitigation 
Strategy (REMS) from manufacturers to ensure that the benefits of a 
drug or biological product outweigh its risks.
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    5. One comment, representing addiction treatment professionals 
expressed great concern about ``the potential negative effect the 
proposed change in regulation would have on the management of opioid 
dependence'' provided by OTPs. Specifically, the comment stated that 
removing the restriction for dispensing buprenorphine and buprenorphine 
combination products in OTPs will lead to poorer treatment outcomes and 
increased diversion. This problem would arise because OTP patients are 
often in programs (as opposed to office-based physician settings) 
because ``they require the structure offered in methadone maintenance 
(frequent dosing within the clinic environment, frequent contact with 
clinical staff).'' The comment contends that ``OTPs are a primary 
referral for patients receiving buprenorphine/naloxone in office-based 
treatment settings who have been unable to comply with treatment 
requirements or to discontinue illicit drug use.'' In addition, the 
comment states that ``patients in methadone maintenance/narcotic 
treatment programs often have more severe illness (poly-substance 
abuse/dependence, co-occurring mental illness, antisocial behaviors 
associated with early drug abuse treatment).''
    The Secretary is not aware of evidence to support the assertion 
that OTPs serve as primary referral centers for non-compliant office-
based patients and those office-based patients unable to discontinue 
drug use, or that OTP patients are more likely to have more severe 
illness compared to patients treated in office-based settings. The 
commenter did not provide evidence that removing the take home 
restrictions for buprenorphine products for patients treated in OTPs 
would interfere with the medical, drug testing, counseling, and other 
services that OTPs are required to provide to patients admitted to 
treatment. In addition, the proposal removes the time in treatment 
schedule for dispensing buprenorphine products but does not remove the 
requirement that every patient is assessed for stability before any 
buprenorphine products are dispensed by an OTP for unsupervised use. As 
discussed above, providers treating patients in OTPs with approved 
buprenorphine products are required under the Drug Addiction Treatment 
Act to provide counseling and other services to patients treated with 
buprenorphine products, and to assess and document patient suitability 
and stability before buprenorphine is prescribed for unsupervised use. 
Office-based buprenorphine providers are not required to provide 
counseling and to assess suitability and stability.
    The same commenter suggested that patients in OTPs are dosed daily 
until stability is demonstrated. Permitting OTPs to dispense 
``buprenorphine products in up to 1-month prescriptions rapidly upon 
starting this therapy will result in patients losing that important 
component of their treatment * * * [and] will result in poorer 
treatment outcomes for this population as well as substantial increases 
in diversion of the drug.'' The commenter believes that increases in 
buprenorphine diversion could jeopardize the availability of 
buprenorphine treatment modality. However, OTPs are not required to 
dispense a one month supply to every patient; programs are required to 
assess patients and dispense amounts that meet criteria for stability.
    Taken together, the Secretary believes that the risk for 
buprenorphine diversion from buprenorphine dispensed by OTPs in 
accordance with this final rule will be less than the risk of diversion 
associated with office-based settings. Nonetheless, at least annually, 
SAMHSA will, in consultation with the

[[Page 72757]]

Office of National Drug Control Policy (ONDCP) and relevant HHS 
agencies, review new data on buprenorphine diversion from OTPs and, if 
necessary, SAMHSA will take formal steps to address this diversion.
    The same comment acknowledges that buprenorphine diversion is 
increasing now, but contends that the risk of diversion ``will increase 
further should generic buprenorphine (without naloxone) become the 
preferred formulation used by narcotic treatment programs.'' The 
comment states that generic single entity (``mono'') formulations will 
be less expensive than the fixed combination buprenorphine/naloxone 
products. OTPs seeking higher profit margins will dispense the less 
expensive and presumptively more abuseable mono formulation, 
contributing to an increase in abuse and diversion.
    The Secretary acknowledges that generic versions of Subutex (a mono 
formulation of buprenorphine) were first approved in October 2009 and 
are priced nominally less than the combination (Suboxone product). 
Generic mono buprenorphine formulations have been available for almost 
two years. The amount of mono buprenorphine prescribed by office-based 
physicians has increased steadily in this period of time to almost 12 
percent of the total number of patients receiving prescriptions in 2010 
(REF 2). As discussed below, the Secretary is aware of reports on 
increasing buprenorphine abuse and diversion, including diversion in 
criminal justice settings (REF 3). The Secretary is not aware of 
compelling evidence to support the assertions that OTPs will 
predominantly dispense mono buprenorphine more than office-based 
physicians. Regardless, as noted above, the controls in place under the 
42 CFR 8.12, will mitigate diversion issues in OTPs with either 
buprenorphine formulation.
    6. One comment expressed concern that the availability of 
buprenorphine treatment through narcotic treatment programs ``could 
discourage office-based practitioners from offering this treatment; 
particularly if third party payers encourage such treatment from 
narcotic treatment programs and introduce barriers to office-based 
treatment.''
    The Secretary is not aware of any evidence to support the 
suggestion the regulatory changes on buprenorphine distribution in OTP 
settings would discourage office-based buprenorphine treatment, or that 
third party payers would react to by creating additional barriers to 
reimbursement for office-based treatment under DATA 2000. Buprenorphine 
products have been available for office-based treatment and for use in 
OTPs since 2003. Buprenorphine treatment has been covered by public and 
private insurance providers in both OTP and office-based settings. It 
is unclear how changing the way buprenorphine products are dispensed by 
OTPs will have any direct or indirect impact on private or public 
reimbursement decisions, or on office-based physicians willingness to 
continue to treat patients in that setting.
    7. One comment recommended that physicians in OTPs be required to 
obtain the waiver to prescribe buprenorphine under DATA 2000, and to 
complete the training that is one of the requirements under DATA 2000. 
The commenter ``believes it would be irresponsible to simply permit 
uneducated physicians working in narcotic treatment programs to begin 
to prescribe this medication with no foundation as to its proper use.'' 
The same comment recommended that non-physician OTP staff also be 
required to obtain education on buprenorphine.
    Another comment, referring to DATA 2000 stated that ``qualified 
physicians are authorized [to use buprenorphine in addiction 
treatment]--not programs.'' The same commenter suggested allowing Nurse 
Practitioners to become qualified to treat these patients.
    The Secretary has carefully considered this recommendation, but 
does not at this time believe that it is necessary to modify the Opioid 
Treatment Regulations to require all OTP physicians to complete 
training and obtain waivers under DATA 2000. The Drug Addiction 
Treatment Act (21 U.S.C. 823(g)(2)(F), did not establish any additional 
training or educational requirements for practitioners, including OTPs 
that dispense Schedule III-V narcotic drugs and are registered as 
treatment programs under 21 U.S.C. 823(g)(1). Indeed, DATA 2000 
specifically authorized treatment programs registered under 21 U.S.C. 
823(g)(1) to use Schedule III--V narcotic drugs for addiction and 
dependence treatment. In addition, 42 CFR 8.12 (d), requires ``that 
each person engaged in the treatment of opioid addiction must have 
sufficient education, training, and experience, or any combination 
thereof, to enable that person to perform the assigned functions.'' 
This requirement applies to OTP program physicians, who order both 
methadone and buprenorphine for patients admitted to OTPs. OTP program 
physicians have been authorized to order buprenorphine products for 
patients admitted to treatment since the interim final rule was issued 
in 2003. Moreover, SAMHSA has analyzed its OTP Medical Director 
database and cross referenced it to the database of physicians with 
DATA waivers. This analysis indicates that as of October 2012 at least 
80 percent of the Medical Directors in OTPs have sought and obtained 
DATA 2000 waivers to prescribe buprenorphine products in office-based 
or other settings.
    As stated elsewhere in this notice, SAMHSA will send a formal 
guidance letter to all OTP Medical Directors, encouraging them to 
complete buprenorphine training and obtain a waiver. In the letter, 
SAMHSA will provide links to Web sites where OTP physicians can 
complete on-line qualifying training and will offer to send the OTP 
physicians a CD-ROM to complete training.
    There are many other resources available to OTP staff on the use of 
buprenorphine in the treatment of opioid dependence. SAMHSA has issued 
two treatment improvement protocols (TIPs): ``TIP 40: Clinical 
Guidelines for the Use of Buprenorphine in the Treatment of Opioid 
Addiction'' and ``TIP 43: Medication Assisted Treatment for Opioid 
Addiction in Opioid Treatment Programs.'' These treatment guidelines 
provide extensive evidence-based clinical guidelines on the use of 
buprenorphine, as well as methadone and other medications in treating 
opioid dependence. These guidelines are supplemented by the SAMHSA-
funded Physician Clinical Support System which provides continuous 
assistance and training to OTP physicians who need more information on 
using buprenorphine in dependence treatment.
    The Treatment Improvement Protocols, discussed above, are also 
available to non-physician OTP Staff. In addition, SAMHSA has developed 
specific guidance for nurses in OTPs or other practice settings such as 
``Technical Assistance Publication 30--Buprenorphine: A Guide for 
Nurses.'' SAMHSA also sponsors continuing medical education seminars 
for nurses on using buprenorphine in OTPs (see www.dpt.samhsa.gov.)
    There is also information available on buprenorphine treatment to 
counselors and other addiction treatment professionals. For example, 
the SAMHSA-supported network of Addiction Technology Transfer Centers 
(ATTCs) offers classroom training and other information on using 
buprenorphine in opioid dependence treatment, including treatment in 
adolescent populations. (See Short-

[[Page 72758]]

Term Opioid Withdrawal Using Buprenorphine: Findings and Strategies 
from a NIDA Clinical Trials Network (CTN) Study, https://www.nattc.org/explore/priorityareas/science/blendinginitiative/bupdetox/).
    The Secretary believes that there are considerable education 
resources available to physicians and non-physician staff in OTPs and 
that these resources are being used. Finally, the Drug Addiction 
Treatment Act authority to prescribe buprenorphine addiction treatment 
products does not extend to practitioners such as nurse practitioners 
or physicians assistants.
    8. One comment recommended that the regulations be modified to 
establish dose limits for patients treated with buprenorphine products 
in OTPs. Specifically, the OTP must document the need for any daily 
dose above 16 mg per day. The commenter provided references to support 
that 16 mg per day occupies 95 percent of the mu-opioid receptor, and 
any dose above that amount invites diversion.
    The existing OTP regulations (42 CFR 8.12(h)(4)) require that 
``each opioid agonist treatment medication used by the program is 
administered and dispensed in accordance with its approved product 
labeling.'' Further, the current regulations require that any 
significant deviations from this labeling, including dosing deviations, 
are documented in the patient record. The Secretary notes that there 
are no daily dose limits applied to physicians who prescribe 
buprenorphine products under their DATA 2000 waiver authority. 
Accordingly, it is not clear whether establishing a specific 16 mg per 
day dose limit for buprenorphine dispensed by OTPs would have a 
measureable impact above the current regulatory requirements. As such, 
the Secretary declines the recommendation to establish buprenorphine 
dose limits for OTPs.
    9. One comment recommended an increase in the required number of 
random urine toxicology screening tests within OTPs to at least twice 
monthly. According to the comment, this level of drug testing is 
necessary to demonstrate that drug use has ceased or has been at least 
reduced.
    The current regulations require, at a minimum, that OTPs conduct at 
least 8 random drug tests each year. These tests must be adequate, and 
are used to monitor a patient's progress in treatment as well as to 
guide the OTP physician on appropriate take-home doses. The comment 
provided no evidence to support how increasing the frequency of drug 
testing in OTPs beyond the minimum of eight per year would produce 
benefits that would outweigh the additional costs. The Secretary notes 
OTPs can conduct more frequent drug testing that can be tailored to 
individual patient needs and treatment status. Further, there is no 
federal regulatory requirement that a physician that prescribes 
buprenorphine products under DATA 2000 waivers conduct any drug testing 
with their patients. This final rule does not increase the number of 
required drug tests in OTPs.
    After carefully analyzing the comments submitted in response to the 
June 2009 NPRM, together with additional information on buprenorphine 
abuse and diversion, the Secretary concludes that the OTP regulations 
should be modified as proposed in the 2009 NPRM. Specifically, the time 
in treatment restrictions are eliminated for buprenorphine products use 
in SAMHSA-certified OTPs.
    There is now even more experience with buprenorphine in the 
treatment of opioid dependence. Since 2002, almost 22,000 physicians 
have sought and obtained the federal certification to prescribe 
buprenorphine products. According to the DEA Automated Reports 
Consolidated Orders System (ARCOS), over 190 million dosage units were 
distributed to pharmacies in 2010, a more than fourfold increase from 
the almost 40 million dosage units distributed in 2006. It should be 
noted that only 1.1 million dosage units were distributed to OTPs 
during 2010. In addition, almost 800,000 individuals received 
buprenorphine addiction treatment prescriptions from office-based 
physicians in 2010, increasing almost fivefold from the 150,000 
estimated in 2006. (REF 4).
    Although buprenorphine abuse and diversion has increased 
concomitantly with the increase in availability according to 
information from published literature reports and from long-standing 
monitoring systems maintained by FDA, SAMHSA, and DEA, the scope, 
extent, and nature of abuse and diversion, while a major concern, are 
considerably less--and qualitatively different than the scope, nature, 
and extent associated with methadone and other Schedule II and Schedule 
III opioid drug products. Nonetheless, there are initiatives underway 
to address escalating buprenorphine abuse and diversion, and its 
consequences. These include the FDA REMS initiative for buprenorphine, 
the Physician Clinical Support System, and the updated buprenorphine 
office-based physician training curriculum.
    One monitoring system is SAMHSA's Drug Abuse Warning Network 
(DAWN). DAWN is a public health surveillance system that monitors drug-
related visits to hospital emergency departments (EDs). Hospital 
emergency department (ED) visits involving the nonmedical use (or 
misuse/abuse) of buprenorphine are increasing with the increased 
availability of buprenorphine products; however, ED visits involving 
the nonmedical use (or misuse/abuse) of buprenorphine are substantially 
less than other opioids in the class. According to the DAWN 2006 
national tables, out of an estimated 741,425 drug-related ED visits 
involving the nonmedical use of pharmaceuticals in 2006, there were an 
estimated 4,440 (95 percent confidence interval [CI] 823 to 8,057) 
visits involving buprenorphine/combinations. The 2010 DAWN indicates 
that out of 1,173,654 drug-related ED visits involving nonmedical use 
of pharmaceuticals in 2010, there were an estimated 15,778 (95 percent 
confidence interval [CI] 10,815 to 20,741) visits involving 
buprenorphine/combinations. While the number of visits in DAWN for 
buprenorphine/combinations doubled between 2007 and 2009, the increase 
between 2009 and 2010 (1,522 more reports) was not significant at the 
p.05 level. The rates for buprenorphine/combinations in 2006 were 1.5 
per 100,000 population and 5.1 per 100,000 population in 2009. Non-
medical use of buprenorphine/combinations has increased almost four-
fold since 2006. (REF 5). It should be noted that analyses of the 
increases in DAWN reports over the years should also factor in 
increases in the number of buprenorphine tablets sold per year. (REF 
6).
    Increasing buprenorphine abuse and misuse has been identified in 
other substance abuse surveillance instruments. For example, the 
Researched Abuse, Diversion and Addiction-Related Surveillance 
(RADARS[supreg]) System is a prescription drug abuse, misuse and 
diversion surveillance system that collects timely product- and 
geographically-specific data. The RADARS System measures rates of 
abuse, misuse and diversion throughout the United States (U.S.). Recent 
information from the RADARS system indicates that abuse of the mono 
formulation of buprenorphine may be increasing. The same system 
suggests that intravenous abuse of the mono formulation has increased 
recently (REF 8).
    Increasing buprenorphine abuse, as measured by DAWN, is a concern, 
and there are measures underway to identify and mitigate this abuse. 
Buprenorphine DAWN reports must be considered in the context of DAWN 
non-medical use

[[Page 72759]]

reports for other opioids. In 2009 there were an estimated 14,266 (95 
percent confidence interval [CI] 8,001 to 20,531) visits involving 
buprenorphine/combinations. The DAWN non-medical use ED visits for 
other opioids for 2010 are as follows:
Oxycodone/combinations--146,355 visits (95 percent C.I. 106,109--
186,602);
Hydrocodone/combinations--95,972 visits (95 percent C.I. 74,472--
117,472);
Fentanyl/combinations--21,196 visits (95 percent C.I. 15,872--26,520);
Hydromorphone/combinations--17,666 (95 percent C.I. 12,502--22,830); 
and,
Methadone--65,945 (95 percent C.I. 52,085--79,806).
    Buprenorphine diversion--NFLIS--The National Forensic Laboratory 
Information System (NFLIS) is a DEA, Office of Diversion Control 
program that collects drug identification results and associated 
information from drug cases analyzed by federal, state, and local 
forensic laboratories. These laboratories analyze substances secured in 
law enforcement operations. NFLIS From 2003 to 2008, the national 
estimated number of methadone items reported in NFLIS more than doubled 
from 4,967 items to 10,459 items (p < 0.05), while buprenorphine 
increased more than 250-fold from 21 items to 5,627 items (p < 0.05). 
The greatest increases in NFLIS items were in the Northeast U.S. where 
per capita distribution of buprenorphine is greatest (REF 7).
    DEA STRIDE--The DEA's System to Retrieve Information from Drug 
Evidence II (STRIDE) collects the results of drug evidence analyzed at 
DEA laboratories across the country. STRIDE reflects evidence submitted 
by the DEA, other federal law enforcement agencies, and some local 
police agencies that was obtained during drug seizures, undercover drug 
buys, and other activities. STRIDE captures data on both domestic and 
international drug cases; however, the following results describe only 
those drugs obtained in the U.S. STRIDE data and their generalization 
are limited by inconsistent and underreporting at the state and local 
level. During 2008, a total of 51,022 drug exhibits or items were 
reported in STRIDE, about 3 percent of the estimated 1.8 million drug 
items analyzed by state and local laboratories during this period. In 
STRIDE, methadone and buprenorphine each represented less than 1 
percent of total drug items reported in 2008. The number of methadone 
items reported in STRIDE increased from 97 items in 2003 to 159 in 
2006, then fell to 130 in 2007 and rose to 165 in 2008. Buprenorphine 
items increased from 8 items in 2003 to 53 items in 2008.
    In sum, buprenorphine abuse and diversion are measureable and 
increasing. The levels of actual abuse (not adjusted for rate of use) 
and diversion are noticeably less than other opioids. The Secretary 
will continue to monitor abuse while applying the specific 
buprenorphine abuse reduction interventions discussed elsewhere in this 
notice. While cognizant of this abuse, the Secretary believes that 
eliminating the time in treatment restrictions for buprenorphine will 
result in more patients treated in structured opioid treatment 
programs, where controls and requirements can be applied to identify 
and address buprenorphine abuse and diversion.
    Importantly, the consequences of buprenorphine abuse further 
distinguish buprenorphine from methadone and other opioids. Two recent 
review articles discuss buprenorphine toxicity. These articles include 
reports from the National Poison Control Centers of the American 
Association of Poison Control Centers. (REFS 8, 9). According to these 
reports, which covered years 2000 through 2008, there were fewer than 
nine buprenorphine associated deaths over the nine year period. During 
the same period of time, there were 654 methadone associated deaths. 
These reports, together with the discussion in the Proposed Rule, 
further distinguish buprenorphine from methadone in overall toxicity. 
One report highlights the risks and severe consequences associated with 
pediatric buprenorphine poisoning. (REF 9). That same article 
recommends special precautions and warnings to mitigate the risk of 
pediatric buprenorphine exposure. Finally, information is presented 
that contrasts buprenorphine and methadone safety concerns for 
treatment for opioid dependence during pregnancy. (REF 9).
    These peer-reviewed articles support the concept that the 
consequences of buprenorphine abuse are fewer and less severe than 
those associated with methadone. Nonetheless, SAMHSA will continue to 
work with other federal agencies, including FDA with its REMS program, 
to develop strategies to minimize the consequences of buprenorphine 
abuse in OTP and office-based settings. In addition, at least annually, 
SAMHSA will, in consultation with ONDCP and relevant HHS agencies, 
review new data on buprenorphine diversion from OTPs and, if necessary, 
SAMHSA will take formal steps to address this diversion, including 
additional provider training or additional guidance on appropriate 
prescribing. As stated elsewhere in this notice, SAMHSA will send a 
formal guidance letter to all OTP Medical Directors, encouraging them 
to complete buprenorphine training and obtain a waiver. In the letter, 
SAMHSA will provide links to Web sites where OTP physicians can 
complete on-line qualifying training and will offer to send the OTP 
physicians a CD-ROM to complete training.
    The Secretary notes that state entities have also initiated 
programs to inform prescribers on buprenorphine and pediatric 
exposures. Under the OTP regulations, all take-home doses dispensed by 
OTPs must be in dispensed in ``packages designed to reduce the risk of 
accidental ingestion, including child proof containers.'' (see 42 CFR 
8.12(i)(5)). Finally, OTPs have considerable experience in treating 
pregnant patients. This final rule will increase the flexibility in how 
OTPs can dispense buprenorphine products, and permit programs to expand 
treatment to this population.
    The Secretary concludes that there is adequate information in the 
administrative record for this rulemaking to eliminate the take-home 
dispensing schedule for buprenorphine products as set forth in Section 
IV.

III. References

1. Substance Abuse and Mental Health Services Administration, 
National Survey of Substance Abuse Treatment Services (N-SSATS): 
2010. Data on Substance Abuse Treatment Facilities. DASIS Series S-
59, HHS Publication No. (SMA) 11-4665. Rockville, MD: Substance 
Abuse and Mental Health Services Administration, 2011.
2. Verispan, SDI, Total Patient Tracker, Data extracted February 10, 
2011.
3. Wish ED, Artigiani E, Billing A, Hauser W, Hemberg J, Shiplet M, 
Dupont RL. The Emerging Buprenorphine Epidemic in the United States, 
J Addict Dis., 2012, Jan;31(1):3-7.
4. Drug Enforcement Administration, Automated Records and 
Consolidated Orders System (ARCOS), 2010 Report on Buprenorphine 
Distribution.
5. Drug Abuse Warning Network, National Estimates, Drug-Related 
Emergency Department Visits for 2004-2010: Nonmedical Use of 
Pharmaceuticals.
6. Johanson, C., Arken, C.L., Di Menza, S., Schuster, C.R., 
``Diversion and Abuse of Buprenorphine: Findings from National 
Surveys of Treatment Patients and Physicians, Drug and Alcohol 
Dependence, 120 (2012), 190-195.
7. National Forensic Laboratory Information System, Drug Enforcement 
Administration, Special Report on Methadone and Buprenorphine, 2010.
8. Dart, R, RADARS report on Buprenorphine and Oxycontin Abuse, 
2011.
9. Maxwell, J.C., McCance-Katz, E.F., ``Indicators of Buprenorphine 
and

[[Page 72760]]

Methadone Abuse: What Do We Know?, The American Journal on 
Addictions, 19: 73-88, 2009.
10. Boyer, E.W., McCance-Katz, E.F., Methadone and Buprenorphine 
Toxicity in Children, The American Journal on Addictions, 19: 89-95, 
2009.

IV. Summary of Final Regulation

    The opioid treatment program regulations (42 CFR part 8) establish 
the procedures by which the Secretary will determine whether a 
practitioner is qualified under Section 303(g) of the CSA (21 U.S.C. 
823(g)(1)) to dispense certain therapeutic narcotic drugs in the 
treatment of individuals suffering from narcotic addiction. These 
regulations also establish the Secretary's standards regarding the 
appropriate quantities of narcotic drugs that may be provided for 
unsupervised use by individuals undergoing such treatment (21 U.S.C. 
823(g)(1)(c)). (See also 42 U.S.C. 290bb-2a.)
    SAMHSA is not changing any of the provisions in Subpart A 
(Accreditation) or Subpart C (Procedures for Review of Suspension or 
Proposed Revocation of OTP Certification and of Adverse Action 
Regarding Withdrawal of Approval of an Accreditation Body). Instead, 
SAMHSA is finalizing an amendment to Subpart B, Certification and 
Treatment Standards. If finalized, the rule would amend only one 
section of Subpart B, Section 8.12(i), Unsupervised or ``take-home'' 
use.
    Under 42 CFR 8.12(i), OTPs must adhere to requirements for 
dispensing treatment medications for unsupervised or ``take-home'' use. 
These restrictions are intended to limit or reduce the potential for 
diversion of these medications to the illicit market. The effect of 
this final rule is to remove the restrictions for dispensing 
buprenorphine and buprenorphine combination products for unsupervised 
or ``take-home'' use while retaining those requirements for methadone 
products. This change will be incorporated by adding the following 
language to 42 CFR 8.12(i)(3): ``The dispensing restrictions set forth 
in paragraphs (i) through (vi) do not apply to buprenorphine and 
buprenorphine products listed under 42 CFR section 8.12(h)(2)(iii).''
    It should be noted that OTPs are still required to assess and 
document each patient's responsibility and stability to handle opioid 
drug products for unsupervised use set forth under 42 CFR 8.12(i)(2) 
and 8.12(i)(3).

V. Regulatory Impact and Notices

Executive Orders 13563 and 12866

    Executive Order 13563 of January 18, 2011 (lmproving Regulation and 
Regulatory Review), explicitly states that our ``regulatory system must 
protect public health, welfare, safety, and our environment while 
promoting economic growth, innovation, competitiveness, and job 
creation.'' Consistent with this mandate, Executive Order 13563 
requires agencies to tailor ``regulations to impose the least burden on 
society, consistent with obtaining regulatory objectives.'' Executive 
Order 13563 also requires agencies to ``identify and consider 
regulatory approaches that reduce burdens and maintain flexibility and 
freedom of choice'' while selecting ``those approaches that maximize 
net benefits.'' This final rule sets forth a regulatory approach that 
will reduce burdens to providers and to consumers, while continuing to 
provide adequate protections for public health and welfare.
    The Secretary has examined the impact of this final rule under 
Executive Order 12866, which directs federal agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages, distributive impacts, and 
equity). This final rule does not establish additional regulatory 
requirements; it allows an activity that is otherwise prohibited. 
According to Executive Order 12866, a regulatory action is 
``significant'' if it meets any one of a number of specified 
conditions, including having an annual effect on the economy of $100 
million; adversely affecting in a material way a sector of the economy, 
competition, or jobs; or if it raises novel legal or policy issues. A 
detailed discussion of the Secretary's analysis is contained in the 
opioid treatment Final Rule published in the Federal Register of 
January 17, 2001 (66 FR 4086-4090). That notice described the impact of 
the opioid treatment regulations, analyzed alternatives, and considered 
comments from small entities. In addition, a Federal Register notice 
published April 17, 2006, offered the opportunity for comments on this 
information collection activity.
    While this is a significant regulatory action as defined by 
Executive Order 12866, the Secretary finds that it does not confer 
significant costs to regulated entities warranting a regulatory 
flexibility analysis. See the Regulatory Flexibility discussion below. 
The rule permits OTPs to dispense buprenorphine and buprenorphine 
combination products for take home use. If opioid treatment programs 
choose to use these products, the new medications will be used in 
accordance with all other standards set forth in the January 17, 2001, 
Final Rule (66 FR 4090). No new regulatory requirements are imposed by 
this final rule; however, some regulatory requirements will be reduced.
    The Secretary anticipates that there will be an overall reduction 
in societal costs if treatment is expanded under this final rule. The 
costs for OTPs to implement this regulatory change are negligible. The 
added flexibility will permit OTPs to dispense buprenorphine products 
more frequently. Insofar as there are costs associated with each 
dispensing activity, this change could lead to lower overall treatment 
costs for OTPs. The added flexibility will also benefit patients, who 
should be able to report to the OTP less frequently, while still 
benefitting from the counseling, medical, recovery and other services 
OTPs provide. There may be additional diversion and abuse risks 
associated with the possible of expansion of treatment, but the 
Secretary believes that the benefits of increased flexibility and 
increased access to care in OTP settings outweigh these possible risks.

Regulatory Flexibility Analysis

    For the reasons outlined above, the Secretary has determined that 
this final rule will not have a significant impact upon a substantial 
number of small entities within the meaning of the Regulatory 
Flexibility Act (5 U.S.C. 605(b)). The flexibility added by this final 
rule will not require addition expenditures by OTPs. Therefore, an 
initial regulatory flexibility analysis is not required for this final 
Rule.
    As mentioned in the section on Executive Orders 13563 and 12866, 
the Secretary anticipates that there will be an overall reduction in 
societal costs if treatment is expanded under this final rule. The 
costs for OTPs to implement this change to regulation are negligible. 
The added flexibility will permit OTPs to dispense buprenorphine 
products more frequently. Insofar as there are costs associated with 
each dispensing activity, this could lead to lower overall treatment 
costs for OTPs. The added flexibility will also benefit patients, who 
should be able to report to the OTP less frequently, while still 
benefitting from the counseling, medical, recovery and other services 
OTPs will provide.
    The Secretary has determined that this rule is not a major rule for 
the purpose of congressional review. For the

[[Page 72761]]

purpose of congressional review, a major rule is one which is likely to 
cause an annual effect on the economy of $100 million; a major increase 
in costs or prices; significant effects on competition, employment, 
productivity, or innovation; or significant effects on the ability of 
U.S.-based enterprises to compete with foreign-based enterprises in 
domestic or export markets. This is not a major rule under the Small 
Business Regulatory Enforcement Fairness Act (SBREFA) of 1996.

Unfunded Mandates

    The Secretary has examined the impact of this rule under the 
Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This rule 
does not trigger the requirement for a written statement under section 
202(a) of the UMRA because it does not impose a mandate that results in 
an expenditure of $100 million (adjusted annually for inflation) or 
more by either state, local, and tribal governments in the aggregate or 
by the private sector in any 1-year.

Environmental Impact

    The Secretary has previously considered the environmental effects 
of this rule as announced in the Final Rule (66 FR 4076 at 4088). No 
new information or comments have been received that would affect the 
agency's previous determination that there is no significant impact on 
the human environment and that neither an environmental assessment nor 
an environmental impact statement is required.

Executive Order 13132: Federalism

    The Secretary has analyzed this final rule in accordance with 
Executive Order 13132: Federalism. Executive Order 13132 requires 
federal agencies to carefully examine actions to determine if they 
contain policies that have federalism implications or that preempt 
state law. As defined in the Order, ``policies that have federalism 
implications'' refer to regulations, legislative comments or proposed 
legislation, and other policy statements or actions that have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.
    The Secretary is publishing this final rule to modify treatment 
regulations that provide for the use of approved opioid agonist 
treatment medications in the treatment of opiate addiction. The 
Narcotic Addict Treatment Act (NATA, Pub. L. 93-281) modified the 
Controlled Substances Act (CSA) to establish the basis for the Federal 
control of narcotic addiction treatment by the Attorney General and the 
Secretary. Because enforcement of these Sections of the CSA is a 
federal responsibility, there should be little, if any, impact from 
this rule on the distribution of power and responsibilities among the 
various levels of government. In addition, this final rule does not 
preempt State law. Accordingly, the Secretary has determined that this 
final rule does not contain policies that have federalism implications 
or that preempt state law.

Paperwork Reduction Act of 1995

    This final rule modifies 42 CFR 8.12(i) by reducing regulatory 
dispensing requirements for buprenorphine and buprenorphine combination 
products that may be used in SAMHSA-certified opioid treatment 
programs. The final rule establishes no new reporting or recordkeeping 
requirements beyond those discussed in the January 17, 2001, Final Rule 
(66 FR 4076 at 4088). On March 7, 2010, the Office of Management and 
Budget approved the information collection requirements of the Final 
Rule under control number 0930-0206.

Privacy Act

    SAMHSA has determined that the Opioid Treatment Waiver Notification 
System (OTWNS) constitutes a system of records under the Privacy Act. 
The Federal Register notice announcing establishment of the 
buprenorphine waiver notification system as a system of records was 
published on April 25, 2002 (67 FR 20543, April 25, 2002). That system 
was assigned the identification number 09-30-0052

Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    Executive Order 13175 (65 FR 67249, November 6, 2000) requires us 
to develop an accountable process to ensure ``meaningful and timely 
input by tribal officials in the development of regulatory policies 
that have tribal implications.'' ``Policies that have tribal 
implications'' as defined in the Executive Order, to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the federal government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the federal government and Indian tribes.''
    This final rule does not have tribal implications. It will not have 
substantial direct effects on tribal governments, on the relationship 
between the federal government and Indian tribes, or on the 
distribution of power and responsibilities between the federal 
government and Indian tribes, as specified in Executive Order 13175.

    Dated: February 23, 2012.
Pamela S. Hyde,
Administrator, SAMHSA.
    Dated: March 8, 2012.
Kathleen Sebelius,
Secretary.

    Editorial Note: This document was received at the Office of the 
Federal Register on November 30, 2012.

List of Subjects in 42 CFR Part 8

    Health professions, Levo-Alpha-Acetyl-Methadol (LAAM), Methadone, 
Reporting and recordkeeping requirements.

    For the reasons set forth above, Part 8 of Title 42 of the Code of 
Federal Regulations is amended as follows:

PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS

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

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


0
2. Section 8.12(i)(3) is revised to read as follows:


Sec.  8.12  Federal opioid treatment standards.

* * * * *
    (i) * * *
    (3) Such determinations and the basis for such determinations 
consistent with the criteria outlined in paragraph (i)(2) of this 
section shall be documented in the patient's medical record. If it is 
determined that a patient is responsible in handling opioid drugs, the 
dispensing restrictions set forth in paragraphs (i)(3)(i) through (vi) 
of this section apply. The dispensing restrictions set forth in 
paragraphs (i)(3)(i) through (vi) of this section do not apply to 
buprenorphine and buprenorphine products listed under paragraph 
(h)(2)(iii) of this section.
* * * * *
[FR Doc. 2012-29417 Filed 12-5-12; 8:45 am]
BILLING CODE 4160-20-P