[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Rules and Regulations]
[Pages 29685-29688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11471]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-275F]
RIN 1117-AA99
Changes to Patient Limitation for Dispensing or Prescribing
Approved Narcotic Controlled Substances for Maintenance or
Detoxification Treatment by Qualified Individual Practitioners
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: On September 20, 2007, the Drug Enforcement Administration
(DEA) published a Notice of Proposed Rulemaking (NPRM) in the Federal
Register (72 FR 53734) proposing to conform its regulations to recent
statutory amendments to the Controlled Substances Act that changed
certain patient limitations for practitioners who dispense or prescribe
certain narcotic drugs for maintenance or detoxification treatment. DEA
received one comment in support of this rulemaking. DEA is finalizing
the rule as proposed.
DATES: Effective Date: This rule is effective June 23, 2008.
[[Page 29686]]
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Overview
On August 2, 2005, the President signed amendments to the
Controlled Substances Act to increase the patient limitation on
prescribing drug addiction treatments by qualified medical
practitioners in group practices from 30 patients for each group to 30
patients for each qualified practitioner in a group (Pub. L. 109-56;
119 Stat. 591) (21 U.S.C. 823(g)(2)).
On December 29, 2006, the President signed amendments to the
Controlled Substances Act to permit certain qualifying physicians to
dispense and prescribe Schedule III, IV, and V narcotic controlled
substances approved by the Food and Drug Administration (FDA)
specifically for use in maintenance or detoxification treatment to up
to 100 patients at any one time, after the practitioner submits to the
Secretary of Health and Human Services (HHS) a notification of the
practitioner's need and intent to treat the increased number of
patients. The amendment was made as part of the Office of National Drug
Control Policy Reauthorization Act of 2006 (ONDCPRA) (Section 1102 of
Pub. L. 109-469, 120 Stat. 3502).
Notice of Proposed Rulemaking
On September 20, 2007 (72 FR 53734), DEA published a Notice of
Proposed Rulemaking (NPRM) proposing to conform DEA regulations to
Public Law 109-56 by removing the requirement in 21 CFR 1301.28(b)(iv)
that limits to 30 the number of patients that could receive maintenance
or detoxification treatment through a group practice. This change means
that each qualifying practitioner whether working individually or in a
group practice may offer maintenance and detoxification treatment to 30
patients at any one time. That NPRM also proposed to conform DEA
regulations to Section 1102 of Public Law 109-469 by permitting certain
qualifying physicians to treat up to 100 patients. As discussed in 21
U.S.C. 823(g)(2)(B) and (D) (and not modified by this rule), to be a
``qualifying physician'' the practitioner must submit to the Secretary
of HHS notification of the practitioner's intent to begin dispensing
the drugs approved by FDA specifically for maintenance or
detoxification treatment. The notification must contain the following
certifications:
The practitioner is registered with DEA as an individual
practitioner.
The practitioner is a ``qualifying physician.'' A
practitioner is a ``qualifying physician'' if he is licensed under
State law and has specific medical certification, training, or
experience in maintenance or detoxification treatment as specified in
the CSA.
With respect to patients to whom the practitioner will
provide such drugs or combinations of drugs, the practitioner has the
capacity to refer the patients for appropriate counseling and other
appropriate ancillary services.
The total number of such patients of the practitioner at
any one time will not exceed the applicable number. The applicable
number is 30, unless, not sooner than one year after the date on which
the practitioner submitted the initial notification, the practitioner
submits a second notification to the Secretary of HHS of the need and
intent of the practitioner to treat up to 100 patients.
The notification to the Secretary of HHS must be in
writing and must state the name and DEA registration number of the
practitioner.
If the practitioner is a member of a group practice, the
notification states the names of the other practitioners in the
practice and identifies the registrations issued for the other
practitioners.
As noted, certain qualifying physicians may treat up to 100
patients, instead of the thirty permitted for all qualifying
physicians. To qualify to treat the additional patients, not sooner
than one year after the practitioner submitted the initial
notification, the practitioner must submit a second notification to the
Secretary of HHS of the need and intent of the practitioner to treat up
to 100 patients. Further, the practitioner must be a ``qualifying
physician'' under 21 U.S.C. 823(g)(2)(G) as discussed above (21 CFR
1301.28(b)(1)(i) and (ii)). These amendments do not change the
requirement that each practitioner must first qualify to prescribe and
dispense these medications for maintenance and detoxification
treatment, or must be prescribing these approved substances using the
``good faith'' exception, found within current regulations at 21 CFR
1301.28(e).
The ``good faith'' exception was established by the Drug Addiction
Treatment Act of 2000, and is not affected by this Final Rule. The
Controlled Substances Act (CSA) (21 U.S.C. 823(g)(2)(D)) states that
not later than 45 days after the Secretary of HHS receives a
notification discussed above, the Secretary shall make a determination
of whether the practitioner meets all requirements for a waiver of the
requirement of separate registration. Upon the expiration of the 45-day
time period, a practitioner who in good faith submits a notification
discussed above and reasonably believes that the conditions specified
in 21 U.S.C. 823(g)(2)(B) through (D) have been met shall, in
dispensing narcotic drugs in schedule III, IV, or V or combinations of
such drugs for maintenance treatment or detoxification treatment, be
considered to have a waiver until notified otherwise by the Secretary
of HHS. The practitioner may commence to prescribe or dispense such
narcotic drugs for maintenance or detoxification treatment prior to the
expiration of the 45-day period if it facilitates the treatment of an
individual patient and both the Secretary and the Attorney General are
notified by the practitioner of the intent to commence prescribing or
dispensing such narcotic drugs.
Background
On October 17, 2000, Congress passed the Drug Addiction Treatment
Act of 2000 (DATA), amending the Controlled Substances Act (CSA) (21
U.S.C. 801 et seq.) to establish ``waiver authority for physicians who
dispense or prescribe certain narcotic drugs for maintenance treatment
or detoxification treatment'' (Pub. L. 106-310, title XXXV; 114 Stat.
1222, codified at 21 U.S.C. 823(g)(2)). Prior to DATA, the Controlled
Substances Act and DEA regulations required practitioners who wanted to
conduct maintenance or detoxification treatment using narcotic
controlled drugs to be registered as a Narcotic Treatment Program (NTP)
in addition to the practitioner's individual registration. The separate
NTP registration authorized the practitioner to dispense or administer,
but not prescribe, narcotic drugs.
With passage of DATA, DEA published a NPRM (68 FR 37429; June 24,
2003) proposing to amend the regulations affecting maintenance and
detoxification treatment for narcotic treatment by establishing an
exemption from the separate registration requirement. After
consideration of the comments received on the NPRM, DEA published a
Final Rule on June 23, 2005 (70 FR 36338). The June 23, 2005, Final
Rule permitted the following:
(1) Qualifying physicians to dispense and prescribe Schedule III,
IV, and V narcotic controlled drugs approved by the Food and Drug
Administration
[[Page 29687]]
specifically for use in maintenance or detoxification treatment.
(2) Narcotic-dependent patients to have one-on-one consultations
with a practitioner in a private practice setting.
(3) Pharmacies to fill prescriptions for Schedule III, IV, and V
narcotic controlled drugs approved by the Food and Drug Administration
specifically for use in maintenance or detoxification treatment.
(4) Practitioners to offer maintenance and detoxification treatment
with Schedule III, IV, and V narcotic controlled drugs approved by the
Food and Drug Administration specifically for use in maintenance or
detoxification treatment to no more than 30 patients in their private
practices without having a second registration as a NTP.
The exemption and other amendments established by the Final Rule
apply to individual practitioners working in traditional NTPs as well
as any other practice setting. The rule does not affect the existing
prohibition against prescribing any Schedule II narcotic controlled
drugs for maintenance or detoxification treatment.
Under the provisions of DATA implementing regulations as codified
in 21 CFR 1301.28(b)(1)(iii) and (iv), the 30-patient limitation
applied equally to individual practices and to group practices (i.e.,
30 patients per group), severely limiting the number of patients that
could be treated by physicians in group practices.
Pursuant to Public Law 109-56 effective on August 2, 2005, and
Section 1102 of Public Law 109-469 effective on December 29, 2006, this
Final Rule makes conforming changes to DEA's regulations at 21 CFR
1301.28(b)(1)(iii) and (iv). Specifically, paragraph (b)(1)(iii) is
amended to permit the treatment of up to 100 patients by a qualifying
practitioner if the necessary criteria are met (i.e., the practitioner
previously was granted authority to dispense or prescribe Schedule III,
IV, or V narcotic controlled drugs or combinations of narcotic
controlled drugs approved by the Food and Drug Administration
specifically for use in maintenance or detoxification treatment without
being separately registered as a narcotic treatment program, and, not
sooner than one year after the submission of the initial notification,
the practitioner submits a second notification to the Secretary of HHS
of the need and intent of the practitioner to treat up to 100 patients)
and notification is submitted to the Secretary of Health and Human
Services. Further, paragraph (b)(1)(iii) is amended by removing the
phrase ``Where the individual practitioner is not a member of a group
practice,'' since there is no longer a distinction between
practitioners in group practices and those practicing independently.
Finally, paragraph (b)(1)(iv) is deleted to remove language regarding
members of group practices.
Relevant to the change regarding the treatment of up to 100
patients, the Director of the Center for Substance Abuse Treatment in
the Department of Health and Human Services issued a letter announcing
the statutory change as follows:
Under ONDCPRA (effective December 29, 2006), physicians who meet
the following criteria may notify the Secretary of Health and Human
Services (HHS) of their need and intent to treat up to 100 patients
at any time: (1) The physician must currently be qualified under
DATA 2000; (2) at least one year must have elapsed since the
physician submitted the initial notification for authorization; (3)
the physician must certify their capacity to refer patients for
appropriate counseling and other appropriate ancillary services; and
(4) the physician must certify that the total number of patients at
any one time will not exceed the applicable number.
DEA emphasizes that practitioners must meet these HHS criteria
before prescribing a Schedule III, IV, or V controlled substance for
narcotic maintenance or detoxification treatment to more than 30
patients at any one time.
Comments Received
DEA received one comment to its NPRM published September 20, 2007
at 72 FR 53734 from an association representing physicians. The
commenter supported the rulemaking as proposed. The commenter strongly
supported the proposed change to conform DEA regulations to the
statutory changes made by Public Law 109-56, believing that the
previous requirement limiting the number of patients who could receive
treatment through a group practice to 30 was a barrier to treatment
access. Further, the commenter supported the proposed change to conform
DEA regulations to Section 1102 of Public Law 109-469, believing that
the requirement for physicians to submit a supplemental notification to
the Secretary of HHS of their need and intent to treat up to 100
patients, not sooner than one year after the practitioner submitted the
initial notification, is ``a reasonable compromise at this time.''
Therefore, DEA is finalizing this rulemaking as proposed.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator, Office of Diversion Control,
has reviewed this regulation and hereby certifies that it has been
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C.
601-612) and that it will not have a significant economic impact on a
substantial number of small entities. This rule relieves a restriction
on practitioners desiring to treat narcotic dependent patients by
removing the 30-patient limit for group practices and by permitting
certain qualifying physicians to treat up to 100 patients after certain
criteria are met. Thus, the changes provide greater access to care for
patients due to increased patient limits.
Executive Order 12866
The Deputy Assistant Administrator further certifies that this rule
has been drafted in accordance with the principles in Executive Order
12866 Section 1(b). It has been determined that this is a significant
regulatory action and, therefore, this action has been reviewed by the
Office of Management and Budget. This rule will not impose additional
costs on practitioners as it simply increases the number of patients
that a practitioner may treat for narcotic dependence. As previously
noted, this change provides greater access to care for patients due to
the increased patient limits.
Executive Order 12988
This rule meets the applicable standards set forth in Sections 3(a)
and 3(b)(2) of Executive Order 12988, Civil Justice Reform.
Executive Order 13132
This rule does not preempt or modify any provision of State law;
nor does it impose enforcement responsibilities on any State; nor does
it diminish the power of any State to enforce its own laws.
Accordingly, this rulemaking does not have Federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
[[Page 29688]]
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This rule will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
List of Subjects in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
0
For the reasons set out above, 21 CFR part 1301 is amended as follows:
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1301 continues to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 886a,
951, 952, 953, 956, 957.
0
2. Section 1301.28 is amended by revising paragraph (b)(1)(iii) and
removing paragraph (b)(1)(iv) to read as follows:
Sec. 1301.28 Exemption from separate registration for practitioners
dispensing or prescribing Schedule III, IV, or V narcotic controlled
drugs approved by the Food and Drug Administration specifically for use
in maintenance or detoxification treatment.
* * * * *
(b)(1) * * *
(iii) The total number of patients to whom the individual
practitioner will provide narcotic drugs or combinations of narcotic
drugs under this section will not exceed 30 at any one time unless, not
sooner than 1 year after the date on which the practitioner submitted
the initial notification to the Secretary of Health and Human Services,
the practitioner submits a second notification to the Secretary of the
need and intent of the practitioner to treat up to 100 patients. A
second notification under this subparagraph shall contain the
certifications required by subparagraphs (i) and (ii) of this
paragraph. The Secretary of Health and Human Services may promulgate
regulations to change the total number of patients.
* * * * *
Dated: May 13, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E8-11471 Filed 5-21-08; 8:45 am]
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