[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 324 Introduced in Senate (IS)]







106th CONGRESS
  1st Session
                                 S. 324

  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 SENATE OF THE UNITED STATES

                            January 28, 1999

  Mr. Hatch (for himself, Mr. Levin, and Mr. Moynihan) introduced the 
 following bill; which was read twice and referred to the Committee on 
                             the Judiciary

_______________________________________________________________________

                                 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.

    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:
            ``(2)(A) Subject to subparagraphs (D) and (G), 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 20, 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 20, 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).
                    ``(IV) A period of 30 days has elapsed after the 
                date on which the notification was submitted, and 
                during such period the practitioner does not receive 
                from the Secretary a written notice that one or more of 
                the conditions specified in subparagraph (B), 
                subparagraph (C), or this subparagraph, have not been 
                met.
            ``(ii) The Secretary shall provide to the Attorney General 
        such information contained in notifications under subparagraph 
        (B) as the Attorney General may request.
            ``(E) If in violation of subparagraph (A) a practitioner 
        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.
            ``(F) In this paragraph, the term `group practice' has the 
        meaning given such term in section 1877(h)(4) of the Social 
        Security Act.
            ``(G)(i) This paragraph takes effect on the date of 
        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 the purposes relating to clause (iii), the 
        Secretary and the Attorney General shall, during the 3-year 
        period beginning on the date of enactment of the Drug Addiction 
        Treatment Act of 1999, make determinations in accordance with 
        the following:
                    ``(I)(aa) The Secretary shall--
                            ``(aaa) 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;
                            ``(bbb) make a determination regarding 
                        whether such waivers have significantly 
                        increased (relative to the beginning of such 
                        period) the availability of maintenance 
                        treatment and detoxification treatment; and
                            ``(ccc) make a determination regarding 
                        whether such waivers have adverse consequences 
                        for the public health.
                    ``(bb) In making determinations under this 
                subclause, the Secretary--
                            ``(aa) may collect data from the 
                        practitioners for whom waivers under 
                        subparagraph (A) are in effect;
                            ``(bb) shall promulgate regulations (in 
                        accordance with procedures for substantive 
                        rules under section 553 of title 5, United 
                        States Code) specifying the scope of the data 
                        that will be required to be provided under this 
                        subclause and the means through which the data 
                        will be collected; and
                            ``(cc) shall, with respect to collecting 
                        such data, comply with applicable provisions of 
                        chapter 6 of title 5, United States Code 
                        (relating to a regulatory flexibility analysis) 
                        and of chapter 8 of such title (relating to 
                        congressional review of agency rulemaking).
                    ``(II) The Attorney General shall--
                            ``(aa) 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;
                            ``(bb) make a determination regarding 
                        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
                            ``(cc) make a determination regarding 
                        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.
            ``(H) During the 3-year period beginning on the date of 
        enactment of the Drug Addiction Treatment Act of 1999, a State 
        may not preclude a practitioner from dispensing narcotic drugs 
        in schedule IV or V, or combinations of such drugs, to patients 
        for maintentance or detoxification treatment in accordance with 
        the Drug Addiction Treatment Act of 1999, unless, before the 
        expiration of that 3-year period, the State enacts a law 
        prohibiting a practitioner from dispensing such drugs or 
        combination of drugs.''.
    (e) Conforming Amendment.--Section 304 of the Controlled Substances 
Act (21 U.S.C. 824) is amended--
            (1) in subsection (a), in the matter following paragraph 
        (5), by striking ``section 303(g)'' each place the term appears 
        and inserting ``section 303(g)(1)''; and
            (2) in subsection (d), by striking ``section 303(g)'' and 
        inserting ``section 303(g)(1)''.
                                 <all>