[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2634 Introduced in House (IH)]


106th CONGRESS
  1st Session
                                H.R. 2634

  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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 29, 1999

 Mr. Bliley (for himself, Mr. Green of Texas, Mr. Oxley, Mr. Boucher, 
 Mr. Cox, Mr. Greenwood, and Mr. Coble) introduced the following bill; 
which was referred to the Committee on Commerce, and in addition to the 
Committee on the Judiciary, for a period to be subsequently determined 
 by the Speaker, in each case for consideration of such provisions as 
        fall within the jurisdiction of the committee concerned.

_______________________________________________________________________

                                 A BILL


 
  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.

    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 
1999''.

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 (I), the requirements of 
paragraph (1) are waived in the case of the dispensing, by a 
practitioner, of narcotic drugs in schedule 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 
dispensing narcotic drugs in schedule 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 physician licensed under State 
        law, and the practitioner has, by training or experience, the 
        ability to treat and manage opiate-dependent patients.
            ``(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 
        40, 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 40, 
        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 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) The Secretary shall provide to the Attorney General such 
information contained in notifications under subparagraph (B) as the 
Attorney General may request.
    ``(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 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 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 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, the term `group practice' has 
the meaning given such term in section 1877(h)(4) of the Social 
Security Act.
    ``(H) During the 3-year period beginning on the date of the 
enactment of the Drug Addiction Treatment Act of 1999, any law or 
regulation of a State or political subdivision of a State that is in 
conflict with this paragraph is superseded by this paragraph. If before 
the expiration of such period a State or political subdivision of a 
State enacts such a law, then upon the expiration of the period this 
paragraph ceases to supersede the law.
    ``(I)(i) This paragraph takes effect on the date of the enactment 
of the Drug Addiction Treatment Act of 1999, 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 1999, 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 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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