[Congressional Record (Bound Edition), Volume 146 (2000), Part 12]
[House]
[Pages 16631-16633]
[From the U.S. Government Publishing Office, www.gpo.gov]



REPRINTED WITH CORRECTED TEXT AND TITLE, AS PASSED BY THE HOUSE ON JULY 
                               19, 2000.

                               H.R. 2634

       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:

[[Page 16632]]

       ``(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

[[Page 16633]]

     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.

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