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 re-
spect to registration requirements for practi-
tioners who dispense narcotic drugs in schedule
IV or V for maintenance treatment or detoxifica-
tion 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
IB
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 require-
ments 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 deter-
mined 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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Drug Addiction Treat-
ment 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 para-
graph:
‘‘(2)(A) Subject to subparagraphs (D) and (I), the re-
quirements 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 combina-
tions of such drugs meet the conditions specified in subpara-
graph (C).
‘‘(B) For purposes of subparagraph (A), the conditions
specified in this subparagraph with respect to a practi-
tioner are that, before dispensing narcotic drugs in schedule
IV or V or combinations of such drugs to patients for main-
tenance or detoxification treatment, the practitioner submit
to the Secretary a notification of the intent of the practi-
tioner to begin dispensing the drugs or combinations for
such purpose, and that the notification contain the fol-
lowing certifications by the practitioner:
‘‘(i) The practitioner is a qualifying physician
(as defined in subparagraph (G)).
‘‘(ii) With respect to patients to whom the prac-
titioner will provide such drugs or combinations of
drugs, the practitioner has the capacity to refer the
patients for appropriate counseling and other appro-
priate ancillary services.
‘‘(iii) In any case in which the practitioner is
not in a group practice, the total number of such pa-
tients of the practitioner at any one time will not ex-
ceed the applicable number. For purposes of this
clause, the applicable number is 40, except that the
Secretary may by regulation change such total num-
ber.
‘‘(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 estab-
lish 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 prac-
tice 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 ap-
proved for use in maintenance or detoxification treat-
ment.
‘‘(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 detoxifica-
tion treatment requires additional standards respect-
ing the qualifications of practitioners to provide such
treatment, or requires standards respecting the quan-
tities of the drugs that may be provided for unsuper-
vised use.
‘‘(D)(i) A waiver under subparagraph (A) with respect
to a practitioner is not in effect unless (in addition to con-
ditions 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 reg-
istrations 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 pro-
vide to the Attorney General all information contained in
such notifications.
‘‘(E)(i) If a practitioner is not registered under para-
graph (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 main-
tenance 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 reg-
istration of the practitioner pursuant to subsection (f) to
be inconsistent with the public interest.
‘‘(ii)(I) A practitioner who in good faith submits a no-
tification 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 mainte-
nance treatment or detoxification treatment, be considered
to have a waiver under subparagraph (A) until notified oth-
erwise by the Secretary.
‘‘(II) For purposes of subclause (I), the publication in
the Federal Register of an adverse determination by the Sec-
retary 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 practi-
tioners, 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 pa-
tients for maintenance or detoxification treatment, a prac-
titioner 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 registra-
tion under paragraph (1), including with respect to the
number of patients who may be served under such a reg-
istration.
‘‘(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 cer-
tification from the American Society of Addic-
tion 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 com-
munications, or otherwise) that is provided by
the American Society of Addiction Medicine, the
American Academy of Addiction Psychiatry, the
American Medical Association, the American Os-
teopathic 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 lead-
ing to the approval of a narcotic drug in sched-
ule IV or V for maintenance or detoxification
treatment, as demonstrated by a statement sub-
mitted 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 physi-
cian to treat and manage opiate-dependent pa-
tients.
‘‘(VII) The physician has such other train-
ing or experience as the Secretary considers to
demonstrate the ability of the physician to treat
and manage opiate-dependent patients. Any cri-
teria 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 peri-
ods as the Secretary considers appropriate for
purposes of this subclause. Such an extension of
criteria may only be effectuated through a state-
ment 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 subdivi-
sion 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 en-
acts 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 Sec-
retary 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 mainte-
nance treatment and detoxification treatment in clin-
ical 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 waiv-
ers have adverse consequences for the public health.
‘‘(II) The Attorney General may make a deter-
mination of the extent to which there have been viola-
tions 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 sub-
paragraph (A) have increased (relative to the begin-
ning 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 pub-
lishes 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 pub-
lication. 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 publica-
tion.’’.
(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 sec-
tion 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.