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





                                                 Union Calendar No. 255

106th CONGRESS

  1st Session

                               H. R. 2634

                      [Report No. 106-441, Part I]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                            November 3, 1999

       Reported from the Committee on Commerce with an amendment

                            November 3, 1999

Referral to the Committee on the Judiciary extended for a period ending 
                    not later than November 3, 1999

                            November 3, 1999

 Committee on the Judiciary discharged; committed to the Committee of 
  the Whole House on the State of the Union and ordered to be printed





                                                 Union Calendar No. 255
106th CONGRESS
  1st Session
                                H. R. 2634

                      [Report No. 106-441, Part I]

  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.

                            November 3, 1999

       Reported from the Committee on Commerce with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

                            November 3, 1999

Referral to the Committee on the Judiciary extended for a period ending 
                    not later than November 3, 1999

                            November 3, 1999

Additional sponsors: Mr. Norwood, Mr. Deal of Georgia, Mr. Rangel, and 
                               Mr. Upton

                            November 3, 1999

 Committee on the Judiciary discharged; committed to the Committee of 
  the Whole House on the State of the Union and ordered to be printed
 [For text of introduced bill, see copy of bill as introduced on July 
                               29, 1999]

_______________________________________________________________________

                                 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 (including the 
prescribing), 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 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 
        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 assign a unique identifier to each 
notification under subparagraph (B), and shall provide to the Attorney 
General all information contained in such notifications.
    ``(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:
            ``(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 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 
                three 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) 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)''.

SEC. 3. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS REGARDING DEPARTMENT 
              OF HEALTH AND HUMAN SERVICES.

    For the purpose of assisting the Secretary of Health and Human 
Services with the additional duties established for the Secretary 
pursuant to the amendments made by section 2, there are authorized to 
be appropriated, in addition to other authorizations of appropriations 
that are available for such purpose, such sums as may be necessary for 
fiscal year 2000 and each subsequent fiscal year.