[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Rules and Regulations]
[Pages 72752-72761]
From the Federal Register Online via the Government Publishing 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: [email protected].
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, http://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