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


  2d Session

                               H. R. 2634

_______________________________________________________________________

                                 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.
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
106th CONGRESS
  2d Session
                                H. R. 2634

_______________________________________________________________________

                                 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)''.

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.

            Passed the House of Representatives July 19, 2000.

            Attest:

                                                                 Clerk.