II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Drug Addiction Treat5 ment Act of 1999’’.

6 SEC. 2. AMENDMENT TO CONTROLLED SUBSTANCES ACT.

7 Section 303(g) of the Controlled Substances Act (21

8 U.S.C. 823(g)) is amended—
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1 (1) in paragraph (2), by striking ‘‘(A) security’’

2 and inserting ‘‘(i) security’’, and by striking ‘‘(B)

3 the maintenance’’ and inserting ‘‘(ii) the mainte4 nance’’;

5 (2) by redesignating paragraphs (1) through

6 (3) as subparagraphs (A) through (C), respectively;

7 (3) by inserting ‘‘(1)’’ after ‘‘(g)’’;

8 (4) by striking ‘‘Practitioners who dispense’’

9 and inserting ‘‘Except as provided in paragraph (2),

10 practitioners who dispense’’; and

11 (5) by adding at the end the following:

12 ‘‘(2)(A) Subject to subparagraphs (D) and (G),

13 the requirements of paragraph (1) are waived in the

14 case of the dispensing, by a practitioner, of narcotic

15 drugs in schedule IV or V or combinations of such

16 drugs if the practitioner meets the conditions speci17 fied in subparagraph (B) and the narcotic drugs or

18 combinations of such drugs meet the conditions

19 specified in subparagraph (C).

20 ‘‘(B) For purposes of subparagraph (A), the

21 conditions specified in this subparagraph with re22 spect to a practitioner are that, before dispensing

23 narcotic drugs in schedule IV or V, or combinations

24 of such drugs, to patients for maintenance or detoxi25 fication treatment, the practitioner submit to the
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1 Secretary a notification of the intent of the practi2 tioner to begin dispensing the drugs or combinations

3 for such purpose, and that the notification contain

4 the following certifications by the practitioner:

5 ‘‘(i) The practitioner is a physician li6 censed under State law, and the practitioner

7 has, by training or experience, the ability to

8 treat and manage opiate-dependent patients.

9 ‘‘(ii) With respect to patients to whom the

10 practitioner will provide such drugs or combina11 tions of drugs, the practitioner has the capacity

12 to refer the patients for appropriate counseling

13 and other appropriate ancillary services.

14 ‘‘(iii) In any case in which the practitioner

15 is not in a group practice, the total number of

16 such patients of the practitioner at any one

17 time will not exceed the applicable number. For

18 purposes of this clause, the applicable number

19 is 20, except that the Secretary may by regula20 tion change such total number.

21 ‘‘(iv) In any case in which the practitioner

22 is in a group practice, the total number of such

23 patients of the group practice at any one time

24 will not exceed the applicable number. For pur25 poses of this clause, the applicable number is
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1 20, except that the Secretary may by regulation

2 change such total number, and the Secretary

3 for such purposes may by regulation establish

4 different categories on the basis of the number

5 of practitioners in a group practice and estab6 lish for the various categories different numeri7 cal limitations on the number of such patients

8 that the group practice may have.

9 ‘‘(C) For purposes of subparagraph (A), the

10 conditions specified in this subparagraph with re11 spect to narcotic drugs in schedule IV or V or com12 binations of such drugs are as follows:

13 ‘‘(i) The drugs or combinations of drugs

14 have, under the Federal Food, Drug and Cos15 metic Act or section 351 of the Public Health

16 Service Act, been approved for use in mainte17 nance or detoxification treatment.

18 ‘‘(ii) The drugs or combinations of drugs

19 have not been the subject of an adverse deter20 mination. For purposes of this clause, an ad21 verse determination is a determination pub22 lished in the Federal Register and made by the

23 Secretary, after consultation with the Attorney

24 General, that the use of the drugs or combina25 tions of drugs for maintenance or detoxification
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1 treatment requires additional standards respect2 ing the qualifications of practitioners to provide

3 such treatment, or requires standards respect4 ing the quantities of the drugs that may be pro5 vided for unsupervised use.

6 ‘‘(D)(i) A waiver under subparagraph (A) with

7 respect to a practitioner is not in effect unless (in

8 addition to conditions under subparagraphs (B) and

9 (C)) the following conditions are met:

10 ‘‘(I) The notification under subparagraph

11 (B) is in writing and states the name of the

12 practitioner.

13 ‘‘(II) The notification identifies the reg14 istration issued for the practitioner pursuant to

15 subsection (f).

16 ‘‘(III) If the practitioner is a member of a

17 group practice, the notification states the

18 names of the other practitioners in the practice

19 and identifies the registrations issued for the

20 other practitioners pursuant to subsection (f).

21 ‘‘(IV) A period of 30 days has elapsed

22 after the date on which the notification was

23 submitted, and during such period the practi24 tioner does not receive from the Secretary a

25 written notice that one or more of the condi-
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1 tions specified in subparagraph (B), subpara2 graph (C), or this subparagraph, have not been

3 met.

4 ‘‘(ii) The Secretary shall provide to the Attor5 ney General such information contained in notifica6 tions under subparagraph (B) as the Attorney Gen7 eral may request.

8 ‘‘(E) If in violation of subparagraph (A) a prac9 titioner dispenses narcotic drugs in schedule IV or V

10 or combinations of such drugs for maintenance

11 treatment or detoxification treatment, the Attorney

12 General may, for purposes of section 304(a)(4), con13 sider the practitioner to have committed an act that

14 renders the registration of the practitioner pursuant

15 to subsection (f) to be inconsistent with the public

16 interest.

17 ‘‘(F) In this paragraph, the term ‘group prac18 tice’ has the meaning given such term in section

19 1877(h)(4) of the Social Security Act.

20 ‘‘(G)(i) This paragraph takes effect on the date

21 of enactment of the Drug Addiction Treatment Act

22 of 1999, and remains in effect thereafter except as

23 provided in clause (iii) (relating to a decision by the

24 Secretary or the Attorney General that this para25 graph should not remain in effect).
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1 ‘‘(ii) For the purposes relating to clause (iii),

2 the Secretary and the Attorney General shall, during

3 the 3-year period beginning on the date of enact4 ment of the Drug Addiction Treatment Act of 1999,

5 make determinations in accordance with the follow6 ing:

7 ‘‘(I)(aa) The Secretary shall—

8 ‘‘(aaa) make a determination of

9 whether treatments provided under waivers

10 under subparagraph (A) have been effec11 tive forms of maintenance treatment and

12 detoxification treatment in clinical settings;

13 ‘‘(bbb) make a determination regard14 ing whether such waivers have significantly

15 increased (relative to the beginning of such

16 period) the availability of maintenance

17 treatment and detoxification treatment;

18 and

19 ‘‘(ccc) make a determination regard20 ing whether such waivers have adverse con21 sequences for the public health.

22 ‘‘(bb) In making determinations under this

23 subclause, the Secretary—
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1 ‘‘(aa) may collect data from the prac2 titioners for whom waivers under subpara3 graph (A) are in effect;

4 ‘‘(bb) shall promulgate regulations (in

5 accordance with procedures for substantive

6 rules under section 553 of title 5, United

7 States Code) specifying the scope of the

8 data that will be required to be provided

9 under this subclause and the means

10 through which the data will be collected;

11 and

12 ‘‘(cc) shall, with respect to collecting

13 such data, comply with applicable provi14 sions of chapter 6 of title 5, United States

15 Code (relating to a regulatory flexibility

16 analysis) and of chapter 8 of such title (re17 lating to congressional review of agency

18 rulemaking).

19 ‘‘(II) The Attorney General shall—

20 ‘‘(aa) make a determination of the ex21 tent to which there have been violations of

22 the numerical limitations established under

23 subparagraph (B) for the number of indi24 viduals to whom a practitioner may provide

25 treatment;
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1 ‘‘(bb) make a determination regarding

2 whether waivers under subparagraph (A)

3 have increased (relative to the beginning of

4 such period) the extent to which narcotic

5 drugs in schedule IV or V or combinations

6 of such drugs are being dispensed or pos7 sessed in violation of this Act; and

8 ‘‘(cc) make a determination regarding

9 whether such waivers have adverse con10 sequences for the public health.

11 ‘‘(iii) If, before the expiration of the period

12 specified in clause (ii), the Secretary or the Attorney

13 General publishes in the Federal Register a decision,

14 made on the basis of determinations under such

15 clause, that this paragraph should not remain in ef16 fect, this paragraph ceases to be in effect 60 days

17 after the date on which the decision is so published.

18 The Secretary shall, in making any such decision,

19 consult with the Attorney General, and shall, in pub20 lishing the decision in the Federal Register, include

21 any comments received from the Attorney General

22 for inclusion in the publication. The Attorney Gen23 eral shall, in making any such decision, consult with

24 the Secretary, and shall, in publishing the decision

25 in the Federal Register, include any comments re-
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1 ceived from the Secretary for inclusion in the publi2 cation.

3 ‘‘(H) During the 3-year period beginning on the

4 date of enactment of the Drug Addiction Treatment

5 Act of 1999, a State may not preclude a practitioner

6 from dispensing narcotic drugs in schedule IV or V,

7 or combinations of such drugs, to patients for

8 maintentance or detoxification treatment in accord9 ance with the Drug Addiction Treatment Act of

10 1999, unless, before the expiration of that 3-year pe11 riod, the State enacts a law prohibiting a practi12 tioner from dispensing such drugs or combination of

13 drugs.’’.

14 (e) CONFORMING AMENDMENT.—Section 304 of the

15 Controlled Substances Act (21 U.S.C. 824) is amended—

16 (1) in subsection (a), in the matter following

17 paragraph (5), by striking ‘‘section 303(g)’’ each

18 place the term appears and inserting ‘‘section

19 303(g)(1)’’; and

20 (2) in subsection (d), by striking ‘‘section

21 303(g)’’ and inserting ‘‘section 303(g)(1)’’.

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