Home > 106th Congressional Bills > H.R. 2634 (rh) To amend the Controlled Substances Act with respect to registration requirements for practitioners who dispense narcotic drugs in schedule IV or V for maintenance treatment or detoxification treatment. [Reported in House] ...H.R. 2634 (rh) To amend the Controlled Substances Act with respect to registration requirements for practitioners who dispense narcotic drugs in schedule IV or V for maintenance treatment or detoxification treatment. [Reported in House] ...
Calendar No. 740
106th CONGRESS
2d Session
H. R. 2634
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 27, 2000
Received; read twice and placed on the calendar
_______________________________________________________________________
AN ACT
To amend the Controlled Substances Act with respect to registration
requirements for practitioners who dispense narcotic drugs in schedule
III, IV, or V for maintenance treatment or detoxification treatment.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Drug Addiction Treatment Act of
2000''.
SEC. 2. AMENDMENT TO CONTROLLED SUBSTANCES ACT.
(a) In General.--Section 303(g) of the Controlled Substances Act
(21 U.S.C. 823(g)) is amended--
(1) in paragraph (2), by striking ``(A) security'' and
inserting ``(i) security'', and by striking ``(B) the
maintenance'' and inserting ``(ii) the maintenance'';
(2) by redesignating paragraphs (1) through (3) as
subparagraphs (A) through (C), respectively;
(3) by inserting ``(1)'' after ``(g)'';
(4) by striking ``Practitioners who dispense'' and
inserting ``Except as provided in paragraph (2), practitioners
who dispense''; and
(5) by adding at the end the following paragraph:
``(2)(A) Subject to subparagraphs (D) and (J), the requirements of
paragraph (1) are waived in the case of the dispensing (including the
prescribing), by a practitioner, of narcotic drugs in schedule III, IV,
or V or combinations of such drugs if the practitioner meets the
conditions specified in subparagraph (B) and the narcotic drugs or
combinations of such drugs meet the conditions specified in
subparagraph (C).
``(B) For purposes of subparagraph (A), the conditions specified in
this subparagraph with respect to a practitioner are that, before the
initial dispensing of narcotic drugs in schedule III, IV, or V or
combinations of such drugs to patients for maintenance or
detoxification treatment, the practitioner submit to the Secretary a
notification of the intent of the practitioner to begin dispensing the
drugs or combinations for such purpose, and that the notification
contain the following certifications by the practitioner:
``(i) The practitioner is a qualifying physician (as
defined in subparagraph (G)).
``(ii) 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.
``(iii) In any case in which the practitioner is not in a
group practice, the total number of such patients of the
practitioner at any one time will not exceed the applicable
number. For purposes of this clause, the applicable number is
30, except that the Secretary may by regulation change such
total number.
``(iv) In any case in which the practitioner is in a group
practice, the total number of such patients of the group
practice at any one time will not exceed the applicable number.
For purposes of this clause, the applicable number is 30,
except that the Secretary may by regulation change such total
number, and the Secretary for such purposes may by regulation
establish different categories on the basis of the number of
practitioners in a group practice and establish for the various
categories different numerical limitations on the number of
such patients that the group practice may have.
``(C) For purposes of subparagraph (A), the conditions specified in
this subparagraph with respect to narcotic drugs in schedule III, IV,
or V or combinations of such drugs are as follows:
``(i) The drugs or combinations of drugs have, under the
Federal Food, Drug, and Cosmetic Act or section 351 of the
Public Health Service Act, been approved for use in maintenance
or detoxification treatment.
``(ii) The drugs or combinations of drugs have not been the
subject of an adverse determination. For purposes of this
clause, an adverse determination is a determination published
in the Federal Register and made by the Secretary, after
consultation with the Attorney General, that the use of the
drugs or combinations of drugs for maintenance or
detoxification treatment requires additional standards
respecting the qualifications of practitioners to provide such
treatment, or requires standards respecting the quantities of
the drugs that may be provided for unsupervised use.
``(D)(i) A waiver under subparagraph (A) with respect to a
practitioner is not in effect unless (in addition to conditions under
subparagraphs (B) and (C)) the following conditions are met:
``(I) The notification under subparagraph (B) is in writing
and states the name of the practitioner.
``(II) The notification identifies the registration issued
for the practitioner pursuant to subsection (f).
``(III) 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 pursuant to subsection (f).
``(ii) Upon receiving a notification under subparagraph (B), the
Attorney General shall assign the practitioner involved an
identification number under this paragraph for inclusion with the
registration issued for the practitioner pursuant to subsection (f).
The identification number so assigned clause shall be appropriate to
preserve the confidentiality of patients for whom the practitioner has
dispensed narcotic drugs under a waiver under subparagraph (A).
``(iii) Not later than 45 days after the date on which the
Secretary receives a notification under subparagraph (B), the Secretary
shall make a determination of whether the practitioner involved meets
all requirements for a waiver under subparagraph (B). If the Secretary
fails to make such determination by the end of the such 45-day period,
the Attorney General shall assign the physician an identification
number described in clause (ii) at the end of such period.
``(E)(i) If a practitioner is not registered under paragraph (1)
and, in violation of the conditions specified in subparagraphs (B)
through (D), dispenses narcotic drugs in schedule III, IV, or V or
combinations of such drugs for maintenance treatment or detoxification
treatment, the Attorney General may, for purposes of section 304(a)(4),
consider the practitioner to have committed an act that renders the
registration of the practitioner pursuant to subsection (f) to be
inconsistent with the public interest.
``(ii)(I) A practitioner who in good faith submits a notification
under subparagraph (B) and reasonably believes that the conditions
specified in subparagraphs (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 under subparagraph (A) until notified
otherwise by the Secretary.
``(II) For purposes of subclause (I), the publication in the
Federal Register of an adverse determination by the Secretary pursuant
to subparagraph (C)(ii) shall (with respect to the narcotic drug or
combination involved) be considered to be a notification provided by
the Secretary to practitioners, effective upon the expiration of the
30-day period beginning on the date on which the adverse determination
is so published.
``(F)(i) With respect to the dispensing of narcotic drugs in
schedule III, IV, or V or combinations of such drugs to patients for
maintenance or detoxification treatment, a practitioner may, in his or
her discretion, dispense such drugs or combinations for such treatment
under a registration under paragraph (1) or a waiver under subparagraph
(A) (subject to meeting the applicable conditions).
``(ii) This paragraph may not be construed as having any legal
effect on the conditions for obtaining a registration under paragraph
(1), including with respect to the number of patients who may be served
under such a registration.
``(G) For purposes of this paragraph:
``(i) The term `group practice' has the meaning given such
term in section 1877(h)(4) of the Social Security Act.
``(ii) The term `qualifying physician' means a physician
who is licensed under State law and who meets one or more of
the following conditions:
``(I) The physician holds a subspecialty board
certification in addiction psychiatry from the American
Board of Medical Specialties.
``(II) The physician holds an addiction
certification from the American Society of Addiction
Medicine.
``(III) The physician holds a subspecialty board
certification in addiction medicine from the American
Osteopathic Association.
``(IV) The physician has, with respect to the
treatment and management of opiate-dependent patients,
completed not less than eight hours of training
(through classroom situations, seminars at professional
society meetings, electronic communications, or
otherwise) that is provided by the American Society of
Addiction Medicine, the American Academy of Addiction
Psychiatry, the American Medical Association, the
American Osteopathic Association, the American
Psychiatric Association, or any other organization that
the Secretary determines is appropriate for purposes of
this subclause.
``(V) The physician has participated as an
investigator in one or more clinical trials leading to
the approval of a narcotic drug in schedule III, IV, or
V for maintenance or detoxification treatment, as
demonstrated by a statement submitted to the Secretary
by the sponsor of such approved drug.
``(VI) The physician has such other training or
experience as the State medical licensing board (of the
State in which the physician will provide maintenance
or detoxification treatment) considers to demonstrate
the ability of the physician to treat and manage
opiate-dependent patients.
``(VII) The physician has such other training or
experience as the Secretary considers to demonstrate
the ability of the physician to treat and manage
opiate-dependent patients. Any criteria of the
Secretary under this subclause shall be established by
regulation. Any such criteria are effective only for 3
years after the date on which the criteria are
promulgated, but may be extended for such additional
discrete 3-year periods as the Secretary considers
appropriate for purposes of this subclause. Such an
extension of criteria may only be effectuated through a
statement published in the Federal Register by the
Secretary during the 30-day period preceding the end of
the 3-year period involved.
``(H)(i) In consultation with the Administrator of the Drug
Enforcement Administration, the Administrator of the Substance Abuse
and Mental Health Services Administration, the Director of the Center
for Substance Abuse Treatment, the Director of the National Institute
on Drug Abuse, and the Commissioner of Food and Drugs, the Secretary
shall issue regulations (through notice and comment rulemaking) or
issue practice guidelines to address the following:
``(I) Approval of additional credentialing bodies and the
responsibilities of additional credentialing bodies.
``(II) Additional exemptions from the requirements of this
paragraph and any regulations under this paragraph.
Nothing in such regulations or practice guidelines may authorize any
Federal official or employee to exercise supervision or control over
the practice of medicine or the manner in which medical services are
provided.
``(ii) Not later than 120 days after the date of the enactment of
the Drug Addiction Treatment Act of 2000, the Secretary shall issue a
treatment improvement protocol containing best practice guidelines for
the treatment and maintenance of opiate-dependent patients. The
Secretary shall develop the protocol in consultation with the Director
of the National Institute on Drug Abuse, the Director of the Center for
Substance Abuse Treatment, the Administrator of the Drug Enforcement
Administration, the Commissioner of Food and Drugs, the Administrator
of the Substance Abuse and Mental Health Services Administration, and
other substance abuse disorder professionals. The protocol shall be
guided by science.
``(I) During the 3-year period beginning on the date of the
enactment of the Drug Addiction Treatment Act of 2000, a State may not
preclude a practitioner from dispensing or prescribing drugs in
schedule III, IV, or V, or combinations of such drugs, to patients for
maintenance of detoxification treatment in accordance with this
paragraph unless, before the expiration of that 3-year period, the
State enacts a law prohibiting a practitioner from dispensing such
drugs or combinations of drug.
``(J)(i) This paragraph takes effect on the date of the enactment
of the Drug Addiction Treatment Act of 2000, and remains in effect
thereafter except as provided in clause (iii) (relating to a decision
by the Secretary or the Attorney General that this paragraph should not
remain in effect).
``(ii) For purposes relating to clause (iii), the Secretary and the
Attorney General may, during the 3-year period beginning on the date of
the enactment of the Drug Addiction Treatment Act of 2000, make
determinations in accordance with the following:
``(I) The Secretary may make a determination of whether
treatments provided under waivers under subparagraph (A) have
been effective forms of maintenance treatment and
detoxification treatment in clinical settings; may make a
determination of whether such waivers have significantly
increased (relative to the beginning of such period) the
availability of maintenance treatment and detoxification
treatment; and may make a determination of whether such waivers
have adverse consequences for the public health.
``(II) The Attorney General may make a determination of the
extent to which there have been violations of the numerical
limitations established under subparagraph (B) for the number
of individuals to whom a practitioner may provide treatment;
may make a determination of whether waivers under subparagraph
(A) have increased (relative to the beginning of such period)
the extent to which narcotic drugs in schedule III, IV, or V or
combinations of such drugs are being dispensed or possessed in
violation of this Act; and may make a determination of whether
such waivers have adverse consequences for the public health.
``(iii) If, before the expiration of the period specified in clause
(ii), the Secretary or the Attorney General publishes in the Federal
Register a decision, made on the basis of determinations under such
clause, that this paragraph should not remain in effect, this paragraph
ceases to be in effect 60 days after the date on which the decision is
so published. The Secretary shall in making any such decision consult
with the Attorney General, and shall in publishing the decision in the
Federal Register include any comments received from the Attorney
General for inclusion in the publication. The Attorney General shall in
making any such decision consult with the Secretary, and shall in
publishing the decision in the Federal Register include any comments
received from the Secretary for inclusion in the publication.''.
(b) Conforming Amendments.--Section 304 of the Controlled
Substances Act (21 U.S.C. 824) is amended--
(1) in subsection (a), in the matter after and below
paragraph (5), by striking ``section 303(g)'' each place such
term appears and inserting ``section 303(g)(1)''; and
(2) in subsection (d), by striking ``section 303(g)'' and
inserting ``section 303(g)(1)''.
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