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106th Congress                                            Rept. 106-441
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     Part 1

======================================================================



 
                  DRUG ADDICTION TREATMENT ACT OF 1999

                                _______
                                

November 3, 1999.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 2634]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Commerce, to whom was referred the bill 
(H.R. 2634) 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, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     5
Background and Need for Legislation..............................     6
Hearings.........................................................    10
Committee Consideration..........................................    10
Committee Votes..................................................    10
Committee Oversight Findings.....................................    10
Committee on Government Reform Oversight Findings................    11
New Budget Authority, Entitlement Authority, and Tax Expenditures    11
Committee Cost Estimate..........................................    11
Congressional Budget Office Estimate.............................    13
Federal Mandates Statement.......................................    18
Advisory Committee Statement.....................................    18
Constitutional Authority Statement...............................    18
Applicability to Legislative Branch..............................    18
Section-by-Section Analysis of the Legislation...................    18
Exchange of Committee Correspondence.............................    21
Changes in Existing Law Made by the Bill, as Reported............    22
Additional Views.................................................    28

                               Amendment

    The amendment is as follows:
    Strike out all after the enacting clause and insert in lieu 
thereof the following:

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.

                          Purpose and Summary

    The purpose of H.R. 2634, the Drug Addiction Treatment Act 
of 1999, is to amend certain Controlled Substances Act (21 
U.S.C. 823) registration requirements for practitioners who 
dispense narcotic drugs in schedule IV or V for maintenance 
treatment or detoxification treatment. It frees qualified 
physicians to treat their addicted patients using schedule IV 
or V drugs, promises to speed the further development and 
approval of schedule IV and V narcotic drugs suitable for 
addiction treatment purposes, and offers the prospect of 
medical treatment for the many Americans for whom other 
treatment programs are out of reach.
    Under existing law, physicians must register with the Drug 
Enforcement Administration (DEA) in order to dispense 
controlled substances. If physicians wish to dispense narcotic 
controlled substances for maintenance and detoxification 
treatment, the physicians must have the additional prior 
approval of the DEA, as well as the endorsement of State and 
local regulatory authorities, and the drugs used in treatment 
must have been approved by the Food and Drug Administration 
(FDA). The bill waives the additional approval process for 
qualified physicians who comply with the waiver procedure. For 
three years following enactment, the bill supersedes any 
conflicting State or local law or regulation.
    The waiver procedure only extends to physicians registered 
to dispense controlled substances and qualified by training or 
experience to treat opiate-dependent patients. Physicians 
activate the waiver mechanism by notifying the Secretary of 
Health and Human Services (the Secretary) in writing of their 
intention to begin treatments and documenting their 
qualifications. The waiver is available for treatment involving 
schedule IV or V controlled substances, alone or in 
combination, and unless the number is adjusted by the 
Secretary, for the treatment of no more than forty patients at 
any one time.
    The bill relies on several safeguards against abuse of the 
waiver procedure. The Secretary may deny access to the waiver 
mechanism in the case of treatments using a particular drug or 
combination of drugs should the Secretary determine that the 
drug or drugs warrant either more demanding physician 
qualification standards or more narrowly defined restrictions 
on the quantities that may be dispensed for unsupervised use.
    Physicians risk the loss of their registration to dispense 
controlled substances and in serious cases criminal 
prosecution, if they dispense schedule IV or V controlled 
substances absent either the existing approval procedure or the 
bill's mechanism waiving the requirements of that procedure.
    Finally, within three years following enactment, the 
Secretary and the Attorney General may end availability of the 
waiver. The Secretary's decision may turn upon determinations 
whether (1) the treatments provided under the waiver mechanism 
have been effective forms of clinical treatment; (2) the 
waivers have increased the availability of treatment; or (3) 
the treatments have had adverse public health consequences. The 
Attorney General's decision may likewise be grounded upon (1) 
the waiver mechanism's adverse public health consequences; (2) 
the extent to which the numerical limitations on patients under 
treatment have been breached; or (3) the extent to which the 
waiver mechanism has contributed to an increase in violations 
of the Controlled Substances Act that involve schedule IV or V 
drugs.

                  Background and Need for Legislation

    Opiate dependency is a large and growing problem in the 
United States. Current estimates suggest that nearly 600,000 
people need treatment for heroin addiction alone. Research 
conducted by the Office of National Drug Control Policy 
suggests a shift from injecting heroin to snorting or smoking 
heroin because of increased purity and the misconception that 
these forms of use will not lead to addiction. It is these 
latter forms of heroin abuse that have led to a significant 
increase of heroin abuse among American high school students.
    Heroin abuse is associated with serious health conditions, 
including fatal overdose, spontaneous abortion, collapsed 
veins, and infectious diseases, including HIV/AIDS and 
hepatitis. The short-term effects of heroin abuse appear soon 
after a single dose and disappear in a few hours. After an 
injection of heroin, the user reports feeling a surge of 
euphoria accompanied by a warm flushing of the skin, a dry 
mouth, and heavy extremities. Following this initial euphoria, 
mental functioning becomes clouded due to the depression of the 
central nervous system.
    Heroin has costs that can never be adequately calculated: 
family breakups, battering and abuse, neglect, malnutrition, 
HIV and hepatitis infections, violence, crime, and deadly 
accidents. No family or community should have to pay the price 
demanded by heroin addiction. Congress has taken action to make 
available treatments for heroin addiction, but must do more in 
light of newer and better treatments under the rubric of the 
Controlled Substances Act.
    The Controlled Substances Act provides much of the 
framework for Federal and State regulation of the manufacture 
and distribution of substances that are subject to abuse but 
that may have beneficial medicinal uses. The Controlled 
Substances Act assigns substances to one of five schedules 
according their potential for abuse, addiction, and medical 
utility. Thus, for instance, schedule I substances (such as 
heroin) have a high potential for abuse, no accepted medical 
use, and are unsafe for use even under medical supervision. 
Schedule II substances (such as methadone) are characterized by 
a high potential for abuse, the prospect of severe addiction 
following abuse, but under tight restrictions have accepted 
medical uses. Schedules III, IV and V substances have accepted 
medical uses, but are less prone to abuse and less likely to be 
addictive. Thus, schedule III is reserved for substances with 
accepted medical utility, whose potential for abuse is less 
than schedule I or II substances, whose abuse may lead to 
moderate or low levels of addiction, such as Tylenol with 
codeine. Schedule V houses medically beneficial substances with 
the least potential for abuse and addiction.
    Medical practitioners may not administer or dispense 
schedule I controlled substances, and they must be registered 
with DEA to administer or dispense controlled substances on 
other schedules. For each controlled substance, DEA insists on 
a level of security, record keeping, and inspections consistent 
with the schedule to which the substance has been assigned.
    Methadone has been a mainstay of opiate addiction treatment 
for over thirty years. Methadone, however, is itself subject to 
abuse and is both a narcotic and a schedule II controlled 
substance. Congress enacted the Narcotic Addict Treatment Act, 
cognizant of the dangers and possible benefits of methadone 
treatment. The Narcotic Addict Treatment Act and its 
implementing regulations establish the minimum specifications 
for programs that treat opiate addiction with narcotic drugs 
such as methadone.
    The Narcotic Addict Treatment Act compels practitioners who 
dispense narcotic drugs for maintenance treatment or 
detoxification treatment to obtain a separate, specific 
registration from DEA every year. The regulations augment this 
basic requirement with an array of instructions that one 
commentary describes in following encapsulated terms:

Program approval and structure:

     Submission of applications (to FDA and state 
authorities);
     Compliance with special DEA security requirements;
     Organizational structure (e.g., primary facility, 
medication unit, program sponsor, medical director); and,
     Notification of FDA and state authorities of 
changes in organizational structure.

Use of ``narcotic drugs''

     Designation of approved medications;
     Security of drug stocks (standards as required by 
the DEA);
     Dosing (initial dose, justification for high 
doses, who may dispense, form and route of medication, 
packaging or take-home doses); and,
     Hospital detoxification treatment.

Clinical standards and required services

     Admission standards (addiction history, 
physiologic dependence, voluntary participation, informed 
consent; exceptions if coming from penal or chronic care 
institutions, pregnant patients, previously treated patients; 
limitations if under 18 years of age);
     Admission evaluation (psychologic and sociologic 
background);
     Medical services (e.g., confirm patient 
suitability, medical evaluations, laboratory studies, 
countersign orders and treatment plans, justify take-home 
medications, physician review of treatment plan);
     Contents of medical evaluation (including history, 
physical examination, laboratory examinations);
     ``Initial treatment plan'' and ``periodic 
treatment plan evaluation'' (describes treatment and 
rehabilitative service needs);
     Referral to vocational rehabilitation, education, 
and employment services;
     Minimal frequency of attendance (quantity of take-
home medication); and,
     Drug testing.

Administrative

     Clinical and administrative record keeping;
     Staffing pattern considerations; and,
     Conduct of research.

Special populations

     Services for pregnant patients;
     Special standards for short-term detoxification 
treatment; and,
     Special standards for long-term detoxification 
treatment.\1\
---------------------------------------------------------------------------
    \1\ Strain & Stitzer, Methadone Treatment for Opioid Dependence, 
Table 2.1. Program Aspects Required or Described by U.S. Federal 
Regulations (DHHS, FDA, 21 CFR Part 291) for Methadone, 18 (1999).
---------------------------------------------------------------------------
    Before the FDA will consider a program application, it must 
have the endorsement of the State authorities in the locale 
where the program is to operate. State prerequisites must be at 
least as rigorous as the Federal standards, many are more so. 
Federal regulations, for instance, limit programs to the 
treatment of patients who have been addicted for at least a 
year. It is not uncommon for a State to raise the bar so that 
only patients who have been addicted for at least two years may 
be treated.
    These multiple layers of protection are not 
inconsequential. They dictate treatment by ``program'' rather 
than by individual physician. Programs are largely found in 
urban areas. In several States, there are no programs at all. 
They chill the development of alternative medication. Only 
methadone and another schedule II substance, levo-alpha-acetyl-
methadol (LAAM), have been approved for program use. The FDA 
approved LAAM, which unlike methadone need not be taken daily, 
in 1993. Yet, largely due to regulatory delays at the Federal 
level and difficulties associated with implementation within 
State regulatory schemes, far fewer than half of the treatment 
programs have been authorized to dispense LAAM.
    The United States has an estimated 810,000 opiate-dependent 
individuals. The most frequently used agent in medically 
supervised opiate withdrawal and maintenance treatment is 
methadone. Combined methadone and LAAM treatment programs reach 
approximately 180,000 opiate-dependent Americans.
    Methadone's half-life is approximately 24 hours and leads 
to a long duration of action and once-a-day dosing. Its long 
duration of action and its slow onset of action blunts its 
euphoric effect, making it unattractive as a principal drug of 
abuse. LAAM, a less commonly used opiate agonist, has a longer 
half-life and may prevent withdrawal symptoms for up to 96 
hours.
    Research and testing led by the National Institute on Drug 
Abuse suggest that at least one substance, buprenorphine 
(expected to be approved by FDA as a schedule V drug for the 
treatment of opiate addiction), particularly in conjunction 
with naloxone, will be an effective supplement for methadone/
LAAM treatment. Buprenorphine has proven to be a very effective 
treatment for detoxification and maintenance in Europe, and is 
expected to be approved for detoxification and maintenance use 
in the United States in the near future.
    Buprenorphine, although expected to be in the least 
dangerous class of controlled substances for treatment of 
addicts, is a narcotic drug and as such would be subject to the 
same regulatory regime as methadone and LAAM. In order to 
encourage the development of such schedule IV and V addiction 
medication, the Drug Addiction Treatment Act creates an 
alternative regulatory pathway, one more compatible with the 
less addictive and less abuse prone substances that populate 
schedules IV and V. To do so, it must navigate a new route 
around the forbidding Federal and State regulations promulgated 
many years ago to address the much more dangerous schedule II 
drugs like methadone.
    According to a July 14, 1999, letter to Ranking Minority 
Member John D. Dingell from Secretary of Health and Human 
Services Donna Shalala, buprenorphine (and buprenorphine/
naloxone in combination) ``has very limited euphorigenic 
effects, and has the ability to precipitate withdrawal in 
individuals who are highly dependent on other opiates. Thus, 
buprenorphine and buprenorphine/nx products are expected to 
have low diversion potential.'' The Secretary also states that 
these drugs should ``increase the amount of treatment capacity 
available and expand the range of treatment options that can be 
used by physicians,'' and that:

          * * * buprenorphine and buprenorphine/nx products are 
        expected to reach new groups of opiate addicts--for 
        example, those who do not have access to methadone 
        programs, those who are reluctant to enter methadone 
        treatment programs, and those who are unsuited to them 
        (this would include for example, those in their first 
        year of opiate addiction or those addicted to lower 
        doses of opiates).

    The simple words of a witness at the July 30, 1999, hearing 
held by the Subcommittee on Health and Environment convey how 
deeply important enactment of the Drug Addiction Treatment Act 
of 1999 would be to men and women struggling with heroin 
addiction. Mr. Odis Rivers, a patient at the Jefferson Avenue 
Treatment Research Program in Detroit, Michigan, introduced 
himself to the Subcommittee with the following testimony:

          I am a recovering heroin addict enrolled in a 
        treatment research project at the Wayne State 
        University School of Medicine. I have been addicted to 
        heroin since 1970. I am a three year veteran of the 
        U.S. Army where I served overseas in South Korea. I 
        became addicted to heroin when I returned from the army 
        in 1970 the same year that I was diagnosed with 
        diabetes. I have made many attempts to overcome my 
        heroin addiction but have always relapsed. Today I am 
        proud to say that I have been drug free for over 6 
        months and feel increasingly confident that I can stay 
        that way.
          The medication, buprenorphine, that I have received 
        at the Jefferson Avenue Treatment Research Program has 
        been one of the most important parts of my recovery. 
        Six months ago when I came to the Research Clinic I was 
        separated from my wife and over the 29 years that I was 
        a heroin addict I had lost the respect of my family. 
        Today I am back with my wife and am looking forward to 
        making up for all of the time I lost with her when I was 
        addicted. I am also very lucky to have a family who has 
        seen that I am attempting to turn my life around. It feels 
        good to have their respect and I can be a big brother again 
        to my sister. That means a lot to me and I know having this 
        respect will help me in my recovery.

                                Hearings

    The Subcommittee on Health and Environment held a hearing 
on H.R. 2634, the Drug Addiction Treatment Act of 1999, on July 
30, 1999. The Subcommittee received testimony from: The 
Honorable Orrin Hatch, Senator, State of Utah, and The 
Honorable Carl Levin, Senator, State of Michigan; Dr. Alan I. 
Leshner, Director, National Institute on Drug Abuse, 
accompanied by Dr. Frank J. Vocci, Director, Medications 
Development Division, National Institute on Drug Abuse; Dr. H. 
Westley Clark, Director, Center for Substance Abuse Treatment, 
Substance Abuse and Mental Health Services Administration; Dr. 
Charles Schuster, Director Clinical Research Division on 
Substance Abuse, Wayne State University, Detroit, Michigan, 
accompanied by Mr. Odis Rivers, Citizen, State of Michigan; Dr. 
Larry L. Alexander, Emergency Room Physician, Baylor Medical 
Center at Irving; Mr. Robert E. Anderson, Director, Research 
and Program Applications, National Association of State Alcohol 
and Drug Abuse Directors; Ms. Jenny Collier-McColl, Director of 
National Policy, Legal Action Center; and Dr. Thomas Kosten, 
President, American Academy of Addiction Psychiatry.

                        Committee Consideration

    On September 30, 1999, the Subcommittee on Health and 
Environment met in open markup session and approved H.R. 2634 
for Full Committee consideration, amended, by a voice vote. On 
October 13, 1999, the Full Committee met in open markup session 
and ordered H.R. 2634 reported to the House, amended, by a 
voice vote, a quorum being present.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House requires 
the Committee to list the record votes on the motion to report 
legislation and amendments thereto. There were no record votes 
taken in connection with ordering H.R. 2634 reported. An 
amendment by Mr. Bliley to authorize such sums as may be 
necessary for FY 2000 and each subsequent fiscal year for 
carrying out the purposes of the legislation was agreed to by a 
voice vote. A motion by Mr. Bliley to order H.R. 2634 reported 
to the House, amended, was agreed to by a voice vote, a quorum 
being present.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held a legislative 
hearing and made findings that are reflected in this report.

           Committee on Government Reform Oversight Findings

    Pursuant to clause 3(c)(4) of rule XIII of the Rules of the 
House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
2634, the Drug Addiction Treatment Act of 1999, would result in 
no new or increased budget authority, entitlement authority, or 
tax expenditures or revenues.

                        Committee Cost Estimate

    While the Committee adopts the CBO estimate submitted 
pursuant to section 402 of the Congressional Budget Act for 
those costs subject to appropriation, the Committee believes 
that CBO's estimates with respect to direct spending are 
significantly overstated. For this reason, the Committee adopts 
its own estimate.

----------------------------------------------------------------------------------------------------------------
                                                                    By fiscal years, in millions of dollars--
                                                               -------------------------------------------------
                                                                  2000      2001      2002      2003      2004
----------------------------------------------------------------------------------------------------------------
                                   CHANGE IN SPENDING SUBJECT TO APPROPRIATION

SAMHSA:
    Authorization Level.......................................         5         5         5         5         5
    Estimated Outlays.........................................         3         5         5         5         5

                                            CHANGE IN DIRECT SPENDING

Medicaid:
    Estimated Budget Authority................................     (\1\)     (\1\)     (\1\)     (\1\)     (\1\)
    Estimated Outlays.........................................     (\1\)     (\1\)     (\1\)     (\1\)    (\1\)
----------------------------------------------------------------------------------------------------------------
\1\ Less than $500,000.

Basis of estimate

    There is no Federal requirement that Medicaid programs pay 
for maintenance or detoxification programs for opiate 
dependency. Secretary of Health and Human Services Donna 
Shalala recognized this fact when she was asked in writing by 
Representative John D. Dingell about ``the expenditure of 
resources by any agency of the federal government'' in order 
toimplement S. 324, the Senate companion to H.R. 2634. The Secretary 
responded in a letter on July 14, 1999, stating that ``to implement S. 
324, additional resources would be required by the Substance Abuse and 
Mental Health Services Administration (SAMHSA), Center for Substance 
Abuse Treatment (CSAT). Resources would be required to process provider 
applications and assess provider qualifications, make a determination 
of adverse use, provide information to the Attorney General, make 
determinations regarding waivers, and collect data and evaluate the 
impact of the program.'' (reproduced in ``Drug Addiction Treatment Act 
of 1999,'' Hearing Before the Subcommittee on Health and Environment of 
the Committee on Commerce, House of Representatives, page 11, Serial 
No. 106-45). The Department does not anticipate that Medicaid will bear 
any significant costs due to this legislation.
    On September 28, 1999, the CBO provided an estimate of S. 
486, the Methamphetamine Anti-Proliferation Act of 1999, to the 
Senate Committee on the Judiciary. S. 486 contained the 
language of S. 324, the Senate companion to H.R. 2634. In that 
estimate, CBO estimated that direct spending would not exceed 
$500,000 in any given year.
    The Committee believes that the original estimate of this 
legislation by CBO was correct. CBO estimated the number of 
individuals who will benefit from the introduction of 
buprenorphine will ultimately be 100,000, but the Committee 
believes that this will not take place in a five-year period. 
According to an internal memorandum prepared by the company 
with marketing rights of Suboxone (the commercial name of 
buprenorphine), the number of patients enrolled in 
buprenorphine programs after the passage of this legislation 
would start at very modest levels and would increase over time, 
reaching 38,000 to 45,000 patients by year 5 and growing each 
subsequent year to a plateau of some 100,000 in the out years. 
The estimates contained in the table below are based on Subutex 
tablet usage data from France, a country with the highest 
penetration of buprenorphine treatment for its opioid-addicted 
population.

----------------------------------------------------------------------------------------------------------------
                           Fiscal year                            2000      2001      2002      2003      2004
----------------------------------------------------------------------------------------------------------------
Number of Patients............................................     4,000    16,000    27,000    33,000    45,000
Effect of H.R. 2634 (in percent)..............................       100        25        12         8         4
Number Due to H.R. 2634.......................................     4,000     4,000     3,240     2,640     1,800
----------------------------------------------------------------------------------------------------------------

    When a new drug is approved for the use of treating 
addicts, regulations are promulgated under the Controlled 
Substances Act for that purpose and for that drug. Each 
regulatory regime is unique. H.R. 2634, however, would allow 
certain physicians to dispense an entire class of drugs 
(Schedule IV and V drugs) approved for that indication by the 
FDA without having to wait for the new regulations. The 
Committee has been diligent in working with the Administration 
for over a year to promulgate regulations as soon as 
buprenorphine is approved by FDA, which the Committee expects 
will occur in December 1999. The Committee estimates that the 
regulations for buprenorphine may be promulgated and finalized 
as late as one year from the date of FDA drug approval.
    Because H.R. 2634 brings this drug to market in advance of 
the regulations under the Controlled Substances Act, CBO 
estimates that H.R. 2634 would accelerate the availability of 
the drug and would lead to 10 percent more people receiving the 
drug than if this legislation had not been enacted.
    The 10 percent effect of the bill on the number of people 
being treated, however, is not a linear relationship, as the 
CBO estimate describes it. The Committee believes that the 
number of patients enrolled in a buprenorphine program will be 
100 percent due to H.R. 2634 in the first year because Schedule 
IV or V medication prescribed in advance of the regulations 
would be solely due to H.R. 2634. Allowing for uncertainty that 
regulations will be finalized for the second year after FDA 
approval, the Committee estimates that as many as 25 percent of 
the patients enrolled in treatment could be ascribed to the 
legislation. The probability that any patients enrolled in 
buprenorphine treatment programs solely due to H.R. 2634 will 
decline markedly over the next few years, with a residual 4 
percent probability in year 5.
    CBO estimates that the average annual cost of treatment 
with buprenorphine would be about $4,300 per person in the year 
2000, evenly divided between the cost of the drug itself and 
the cost of related medical and mental health services. The 
Committee believes that CBO erred in ascribing mental health 
services to the cost of H.R. 2634. Any patient who is enrolled 
in a drug treatment program for opioid addiction is already 
receiving these ancillary services; substituting one drug 
treatment program for a less effective one will have no impact 
on the consumption of ancillary services like mental health 
counseling. The Committee believes it is an appropriate 
estimate that the buprenorphine treatments will cost 
approximately $2,150 for a twelve month period.
    CBO also estimated that in 1992 about 12 percent of all 
methadone treatment was paid for by Medicaid, and assumed that 
a similar share of the buprenorphine market would be paid for 
by Medicaid. The Committee believes that CBO overestimated 
those numbers. Methadone treatment is largely reserved for 
those who have been addicted to relatively high levels of 
opioids (generally heroin) for a relatively long period of 
time. Typically, an addict cannot enroll in a methadone program 
until he or she has been addicted for a year, by which time the 
drug has done its damage and the addict can no longer work 
productively. Long-term drug addiction is a major cost driver 
in public assistance programs.
    In the July 14th letter to Representative John D. Dingell, 
``buprenorphine and buprenorphine/nx products are expected to 
reach new groups of opiate addicts--for example, those who do 
not have access to methadone programs, those who are reluctant 
to enter methadone programs, and those who are unsuited to them 
(this would include, for example,those in their first year of 
opiate addiction or those addicted to lower doses of opiates).'' Those 
patients enrolled in methadone treatment programs have a greater 
propensity to be Medicaid eligible (oftentimes, due to their addiction) 
than those who would be appropriate for buprenorphine treatment. The 
Committee believes that Medicaid eligible addicts will comprise as much 
as 9 percent of those patients for whom buprenorphine treatment would 
be appropriate. For this estimate, the Committee believes that CBO is 
correct in assuming that 57 percent of Medicaid costs will be 
reimbursed by the Federal government.
    For the aforementioned reasons, the Committee believes that 
its estimate more accurately reflects the costs associated with 
the enactment of H.R. 2634 than the CBO estimate reprinted 
below.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                  Washington, DC, October 29, 1999.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2634, the Drug 
Addiction Treatment Act of 1999.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Cyndi 
Didzinski (for costs to the Substance Abuse and Mental health 
Services Administration); Dorothy Rosenbaum (for Medicaid 
costs); Lisa Cash Driskill (for the state and local impact); 
and John Harris (for the private-sector impact).
            Sincerely,
                                          Barry B. Anderson
                                    (For Dan L. Crippen, Director).
    Enclosure.

H.R. 2634--Drug Addiction Treatment Act of 1999

    Summary: H.R. 2634 would amend the Controlled Substances 
Act of 1970 to enable qualifying practitioners who wish to 
dispense narcotic drugs in schedule IV or V for detoxification 
treatment to apply to the Secretary of Health and Human 
Services (HHS) for a waiver of the Drug Enforcement 
Administration's (DEA's) registration requirements. The program 
would be implemented by the Substance Abuse and Mental Health 
Services Administration (SAMHSA). The bill would authorize the 
appropriation of such sums as may be necessary for fiscal year 
2000 and each subsequent year to pay for implementing the 
program and processing the waiver application, but specifies 
that no more than $5 million per year may be obligated for this 
activity. Assuming appropriation of the necessary amounts, CBO 
estimates that implementing H.R. 2634 would cost the federal 
government about $80 million over the 2000-2004 period--$23 
million in administrative costs for SAMSHA and $30 million in 
additional Medicaid spending. Because the bill would affect 
direct spending, pay-as-you-go procedures would apply.
    H.R. 2634 contains an intergovernmental mandate as defined 
in the Unfunded Mandates Reform Act (UMRA), but CBO estimates 
that the costs would not be significant and would not exceed 
the threshold established in that act ($50 million in 1996, 
adjusted annually for inflation). This bill would impose no new 
private-sector mandates as defined in UMRA.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 2634 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                    By fiscal years, in millions of dollars--
                                                               -------------------------------------------------
                                                                  2000      2001      2002      2003      2004
----------------------------------------------------------------------------------------------------------------
                                   CHANGE IN SPENDING SUBJECT TO APPROPRIATION

SAMHSA:
    Authorized Level..........................................         5         5         5         5         5
    Estimated Outlays.........................................         3         5         5         5         5
                                            CHANGE IN DIRECT SPENDING
Medicaid:
    Estimated Budget Authority................................     (\1\)         5         5        10        10
    Estimated Outlays.........................................     (\1\)         5         5        10        10
----------------------------------------------------------------------------------------------------------------
\1\ Less than $500,000.

    Basis of estimate: Under current law, physicians wishing to 
dispense narcotic drugs to treat narcotic dependence must first 
apply to HHS, which determines whether they are qualified to 
provide such treatment. Qualified physicians must then apply to 
DEA to be registered separately to dispense (not prescribe) 
such narcotic drugs in treatment. H.R. 2634 would permit 
physicians to dispense and prescribe narcotic drugs in schedule 
IV or V (the drugs rated the lowest risk for abuse) for 
maintenance or detoxification treatment, under certain 
conditions, instead of obtaining a separate DEA registration.
    Under the waiver program in H.R. 2634, interested qualified 
practitioners would notify the Secretary of HHS, in writing, of 
their intent and certify that they meet the conditions in the 
bill relating to state licensing, training and experience, and 
other requirements. Physicians would proceed to provide such 
treatment unless they were notified otherwise by the Secretary. 
The bill would also authorize the Secretary to establish, by 
regulation, criteria for determining the necessary training and 
experience for qualified physicians. At any time during the 
three-year period following the enactment of this legislation, 
the Secretary, in consultation with the Attorney General, would 
be able to publish a decision to terminate the program based on 
specific adverse findings. If such a decision were published, 
the program would be eliminated within 60 days.

Spending subject to appropriation action

    H.R. 2634 would create several new responsibilities for 
SAMHSA. Based on information from SAMHSA, CBO estimates that $5 
million per year would be required to fund the additional staff 
to formulate and publish regulations, establish an appropriate 
training curriculum, design practice guidelines, oversee 
practitioners, set up data base containing the names of 
practitioners who receive waivers, process providers' 
applications, and assess their qualifications. In addition, 
during the first three years, SAMHSA would collect data and 
provide information to the Attorney General to evaluate the 
impact of the program and make a determination of adverse use. 
Provided the program is not terminated, the provisions in H.R. 
2634 would increase discretionary spending by a total of $23 
million over fiscal years 2000 through 2004. This estimate 
assumes that the necessary amounts would be appropriated for 
each fiscal year and that outlays would follow historical 
spending rates for similar activities.

Direct spending

    Medicaid. CBO estimates that enacting H.R. 2634 would 
increase federal Medicaid spending by $30 million over the 
2000-2004 period because more Medicaid beneficiaries would 
receive new schedule IV and V narcotics over that period than 
under current law. Currently, no schedule IV or V narcotics are 
approved for outpatient maintenance or detoxification 
treatment. Methadone, a schedule II narcotic, is the principal 
narcotic currently used in treating opiate addiction. The 
distribution of methadone is regulated so that only certain 
providers who are registered with DEA may dispense it, and the 
daily doses usually must be provided in clinical settings and 
combined with counseling and other treatment services.
    Later this year, the Food and Drug Administration (FDA) is 
expected to approve a new substance, buprenorphine, for the 
treatment of opiate addiction. According to HHS, buprenorphine 
is likely to be approved as a schedule IV or V narcotic because 
it has been found to have limited euphorigenic effects and 
therefore low desirability for sale on the street. Under 
current law, it is unclear exactly how buprenorphine will be 
distributed. Assuming FDA approves the drug, HHS and DEA will 
develop regulations to govern its distribution. Many experts 
believe that it would be appropriate to allow physicians to 
prescribe the drug from their office-based settings and to 
distribute it through commercial pharmacies, but final 
decisions and regulations will probably take about a year. 
Furthermore, under current law, many states have their own 
regulations governing the distribution of narcotics.
    H.R. 2634 would specifically waive the DEA registration 
requirement that would otherwise apply to physicians who wish 
to prescribe buprenorphine and would allow physicians to 
prescribe that drug from their office-based settings. In 
addition, the bill would supersede state regulations for three 
years. CBO expects that enacting the bill would lead to 
somewhat wider distribution of buprenorphine than would 
otherwise occur--for two reasons. First, implementation of 
office-based distribution would probably occur faster than 
under current law and, second, the regulations that the 
Administration would issue under current law would probably be 
more restrictive than the procedures allowed by the bill.
    Based on information from the National Institute on Drug 
Abuse, CBO estimates that ultimately about 100,000 individuals 
will receive buprenorphine each year if it is distributed 
through office-based settings. CBO expects that enactment of 
the bill would speed up the penetration of buprenorphine by one 
to two years and would ultimately lead to 10 percent more 
people receiving the drug. CBO further estimates that the 
average annual cost of treatment with buprenorphine would be 
about $4,300 per person in 2000, evenly divided between the 
cost of the drug itself and the cost of related medical and 
mental health services. According to a report by the Institute 
of Medicine, in 1992 about 12 percent of all methadone 
treatment was paid for by Medicaid. For this estimate, CBO 
assumes that the same proportion of buprenorphine treatment 
would be covered by Medicaid, and that 57 percent of those 
costs would be reimbursed by the Federal Government. In 
addition, CBO estimates that one quarter of the costs of 
buprenorphine treatment under the bill either would occur under 
current law or would be offset by reduced use of other medical 
or mental health services.
    Drug Enforcement Administration. CBO estimates that 
implementing H.R. 2634 would have a negligible effect on the 
DEA. The agency collects a fee--$70 a year, or $210 every three 
years--from each practitioner for dispensing controlled 
substances (including narcotics) and uses these collections to 
fund its registration activities. Because most, if not all, 
practitioners will dispense some controlled substances that are 
not covered by the waiver provided by the bill, enacting H.R. 
2634 would probably not affect the amount of collections. The 
bill's effect on DEA's spending for registration activities 
would be very small because relatively few practitioners are 
expected to apply for the waiver.
    Pay-as-you-go considerations: The Balanced Budget and 
Emergency Deficit Control Act sets up pay-as-you-go procedures 
for legislation affecting direct spending or receipts. The net 
changes in outlays and governmental receipts that are subject 
to pay-as-you-go procedures are shown in the following table. 
For the purposes of enforcing pay-as-you-go procedures, only 
the effects in the current year, the budget year, and the 
succeeding four years are counted.

                                  SUMMARY OF PAY-AS-YOU-GO EFFECTS OF H.R. 2634
----------------------------------------------------------------------------------------------------------------
                                                          By fiscal years, in millions of dollars--
                                           ---------------------------------------------------------------------
                                             2000   2001   2002   2003   2004   2005   2006   2007   2008   2009
----------------------------------------------------------------------------------------------------------------
Changes in outlays........................      0      5      5     10     10     10      5      5      5      5
Changes in receipts.......................                              Not Applicable
----------------------------------------------------------------------------------------------------------------

    Estimated impact on state, local, and tribal governments: 
H.R. 2634 contains an intergovernmental mandate as defined in 
the Unfunded Mandates Reform Act (UMRA). The bill would 
preempt,for three years, a state's ability to regulate the 
distribution of certain narcotic drugs for detoxification 
treatment. If, within that period, a state enacted a law in 
conflict with the bill, that law would go into effect at the 
end of the three-year period. Because states would not be 
required to take any action, however, CBO estimates the cost of 
this preemption would be insignificant.
    Because the bill would increase the number of Medicaid 
beneficiaries that receive new schedule IV and V narcotics for 
detoxification treatment, CBO estimates that Medicaid spending 
by states would increase by about $20 million over the 2000-
2004 period.
    Estimated impact on the private sector: This bill would 
impose no new private-sector mandates as defined in UMRA.
    Previous CBO estimates: In September 1999, CBO provided an 
estimate of S. 486, the Methamphetamine Antiproliferation Act 
of 1999. That bill contained provisions similar to those in 
H.R. 2634. In that estimate, CBO did not include the costs to 
the Medicaid program of changing the law to make schedule IV 
and IV narcotics more easily distributed.
    Estimate prepared by: Federal Costs: Substance Abuse: Cyndi 
Dudzinski; Medicaid: Dorothy Rosenbaum; and Drug Enforcement 
Administration: Mark Grabowicz. Impact on State, Local, and 
Tribal Governments: Lisa Cash Driskall. Impact on the Private 
Sector: John Harris.
    Estimate approved by: Robert A. Sunshine, Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 provides the short title of the Act, the ``Drug 
Addiction Treatment Act of 1999.''

Section 2. Amendment to Controlled Substances Act

    Section 2 amends section 303(g) of the Controlled 
Substances Act (21 U.S.C. 823(g)) to permit a waiver of the 
separate registration required before practicing physicians may 
administer narcotic drugs for maintenance treatment or 
detoxification treatment purposes. The section establishes a 
waiver procedure that allows practitioners to treat addicted 
patients with narcotic drugs in schedule IV or V but without 
the encumbrances that accompany treatment with schedule II 
narcotic drugs.
    Section 2(a)(1) redesignates subsection 303(g) of the 
Controlled Substances Act as paragraph 303(g)(1) and makes 
other technical and conforming changes consistent with 
preservation of the separate registration procedure for 
methadone and LAAM treatment programs.
    Paragraph 2(a)(2) establishes the new waiver mechanism for 
schedule IV or V treatment programs and places it in paragraph 
303(g)(2). The waiver is available to qualified physicians for 
maintenance treatment and detoxification treatment using 
approved schedule IV or V narcotic drugs, either alone or in 
combination.
    Physicians who wish to use the waiver must notify the 
Secretary of their intentions, certifying (1) that they meet 
one or more of the training and experience demands defined in 
section 303(g)(2)(G); (2) that they have the capacity to refer 
patients to counselling and other ancillary services as 
appropriate; and (3) that they will honor the limitations 
placed on the number of patients they may treat at any one 
time. Subject to regulatory adjustment by the Secretary, 
neither sole practitioners nor any collection of physicians 
practicing as a group may treat more than 40 patients at any 
one time. In the case of group practices, the Secretary has the 
authority to set different numerical ceilings according to the 
number of practitioners in the group.
    The waiver extends only to drugs, or drugs in combinations, 
approved for maintenance and detoxification treatment either by 
virtue of the Federal Food, Drug and Cosmetic Act or section 
351 of the Public Health Service Act (42 U.S.C. 262) (relating 
to the regulation of biological products). The Secretary, in 
consultation with the Attorney General, may narrow the range of 
drugs or combinations approved for treatment upon an adverse 
determination, announced in the Federal Register, based upon 
the conclusion that they should be subject to more demanding 
practitioner qualification standards or to more stringent 
standards with respect to the amounts dispensed for 
unsupervised use.
    Notification of an intent to claim the waiver must be in 
writing and identify the physician, his or her DEA controlled 
substance registration, and for group practitioners, the names 
and DEA registrations of the members of the group. The 
Secretary assigns a unique identifier to each notification. The 
Secretary also shares the information from the notifications 
with Attorney General.
    A practitioner who fails to comply with the waiver 
requirements runs the risk of losing his or her registration to 
dispense controlled substances. Unless a physician holds a 
separate registration under section 303(g)(1) (the existing 
narcotics treatment program procedure), the Attorney General 
may consider it inconsistent with the public interest for a 
practitioner to dispense narcotic drugs in schedule IV or V, 
alone or in combination, for maintenance or detoxification 
treatment while failing to comply with the waiver provisions of 
section 303(g)(2). The Attorney General may deny a registration 
to dispense controlled substances generally upon a 
determination that ``issuance of such registration would be 
inconsistent with the public interest.'' A charge of failure to 
comply with the waiver procedures, however, is subject to a 
good faith defense, as long as the breach is not contrary to a 
physician-qualification-drug-quantity,adverse determination 
appearing in the Federal Register at least 30 days prior to filing of 
the practitioner's notification of intent.
    Physicians may elect to treat patients with schedule IV or 
V narcotic drugs under either the registration procedure of 
section 303(g)(1) or the waiver mechanism of section 303(g)(2). 
The waiver mechanism cannot be construed to alter any of the 
features of the registration procedure including limits on the 
number of patients who may be treated at one time. The 
definition of group practice is drawn from paragraph 1877(h)(4) 
of Social Security Act (42 U.S.C. 1395nn(h)(4)(A)).
    Qualified physicians for purposes of a waiver include only 
those who: (1) hold an American Board of Medical Specialties 
subspecialty board certification in addiction psychiatry; (2) 
hold an American Society of Addiction Medicine addiction 
certification; (3) hold an American Osteopathic Association 
subspecialty board certification in addiction medicine; (4) 
have completed at least eight hours of training opiate-
dependent patient treatment and management 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 designated by the 
Secretary; (5) have been an investigator in a clinical trial 
leading to approval of a schedule IV or V narcotic drug for 
maintenance or detoxification treatment; (6) have such training 
or experience as the State medical licensing board considers 
sufficient to evidence an ability to treat and manage opiate-
dependent patients; or (7) have such other training or 
experience as the Secretary considers sufficient to evidence 
such ability. This section clarifies that Federal regulations 
only apply to practitioners who do not comply with the 
qualifications in paragraphs I-VII, and that the Secretary's 
criteria must be established by regulations that sunset after 
three years.
    Section 303(g)(2) supersedes any conflicting State or local 
law or regulation during the three years following enactment. 
State or local provisions enacted during that period become 
effective when it expires.
    At any time during the three years following enactment, the 
Attorney General or the Secretary, each after consulting with 
the other, may terminate the waiver mechanism after announcing 
their decision in the Federal Register. The Secretary's 
determination must be based on whether treatments under the 
waiver procedure have been effective in a clinical environment, 
whether the waiver mechanism has significantly increased the 
availability of treatment, and whether it has adversely 
affected the public health. The Attorney General's 
determination must consider the extent to which the limitations 
on the number of patients a physician may treat have been 
exceeded, the extent to which the mechanism has contributed to 
the possession and dispensing of schedule IV or V narcotic 
drugs in violation of the Controlled Substances Act, and the 
extent to which the waiver procedure has adversely affected the 
public health.
    Paragraph 2(b) of the bill provides conforming amendments 
in section 304 of the Controlled Substances Act (21 U.S.C. 824) 
to reflect continuation of the registration procedure and 
establishment of the waiver mechanism.

Section 3. Additional authorization of appropriations regarding 
        department of Health and Human Services

    Section 3 authorizes appropriations for such sums as are 
necessary to carry out the purposes of the Act in addition to 
other authorizations of appropriations that are available for 
such purpose.

                  Exchange of Committee Correspondence

                          House of Representatives,
                                Committee on the Judiciary,
                                  Washington, DC, October 25, 1999.
Hon. Tom Bliley,
Chairman, House Commerce Committee, House of Representatives, Rayburn 
        House Office Building, Washington, DC.
    Dear Chairman Bliley: I am writing to you concerning the 
bill H.R. 2634, the Drug Addiction Treatment Act of 1999.
    As you know, this bill contains language which falls within 
the Rule X jurisdiction of this committee relating to the 
Controlled Substances Act. I understand that you would like to 
proceed expeditiously to the floor on this matter. I am willing 
to waive our committee's right to mark up this bill. However, 
this, of course, does not waive our jurisdiction over the 
subject matter on this or similar legislation, or our desire to 
be conferees on this bill should it be subject to a House-
Senate conference committee.
    I would appreciate your placing this exchange of letters in 
the Congressional Record. Thank you for your cooperation on 
this matter.
            Sincerely,
                                             Henry J. Hyde,
                                                          Chairman.
                                ------                                

                          House of Representatives,
                                     Committee on Commerce,
                                  Washington, DC, October 21, 1999.
Hon. Henry Hyde,
Chairman, Committee on the Judiciary, House of Representatives, Rayburn 
        House Office Building, Washington, DC.
    Dear Chairman Hyde: Thank you for your letter regarding 
your Committee's jurisdictional interest in H.R. 2634, the Drug 
Addiction Treatment Act of 1999.
    I acknowledge your committee's jurisdiction over this 
legislation and appreciate your cooperation in moving the bill 
to the House floor expeditiously. I agree that your decision to 
forego further action on the bill will not prejudice the 
Judiciary Committee with respect to its jurisdictional 
prerogatives on this or similar legislation, and will support 
your request for conferees on those provisions within the 
Committee on the Judiciary's jurisdiction should they be the 
subject of a House-Senate conference. I will also include a 
copy of your letter and this response in the Committee's report 
on the bill and the Congressional Record when the legislation 
is considered by the House.
    Thank you again for your cooperation.
            Sincerely,
                                                Tom Bliley,
                                                          Chairman.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

                      CONTROLLED SUBSTANCES ACT

           *       *       *       *       *       *       *



                  TITLE II--CONTROL AND ENFORCEMENT

           *       *       *       *       *       *       *



Part C--Registration of Manufacturers, Distributors, and Dispensers of 
Controlled Substances; Piperidine Reporting

           *       *       *       *       *       *       *



                       registration requirements

  Sec. 303. (a) * * *

           *       *       *       *       *       *       *

  (g)(1) [Practitioners who dispense] Except as provided in 
paragraph (2), practitioners who dispense narcotic drugs to 
individuals for maintenance treatment or detoxification 
treatment shall obtain annually a separate registration for 
that purpose. The Attorney General shall register an applicant 
to dispense narcotic drugs to individuals for maintenance 
treatment or detoxification treatment (or both)--
          [(1)] (A) if the applicant is a practitioner who is 
        determined by the Secretary to be qualified (under 
        standards established by the Secretary) to engage in 
        the treatment with respect to which registration is 
        sought;
          [(2)] (B) if the Attorney General determines that the 
        applicant will comply with standards established by the 
        Attorney General respecting [(A) security] (i) security 
        of stocks of narcotic drugs for such treatment, and 
        [(B) the maintenance] (ii) the maintenance of records 
        (in accordance with section 307) on such drugs; and
          [(3)] (C) if the Secretary determines that the 
        applicant will comply with standards established by the 
        Secretary (after consultation with the Attorney 
        General) respecting the quantities of narcotic drugs 
        which may be provided for unsupervised use by 
        individuals in such treatment.
  (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.

           *       *       *       *       *       *       *


           denial, revocation, or suspension of registration

  Sec. 304. (a) A registration pursuant to section 303 to 
manufacture, distribute, or dispense a controlled substance or 
a list I chemical may be suspended or revoked by the Attorney 
General upon a finding that the registrant--
          (1) has materially falsified any application filed 
        pursuant to or required by this title or title III;
          (2) has been convicted of a felony under this title 
        or title III or any other law of the United States, or 
        of any State, relating to any substance defined in this 
        title as a controlled substance or a list I chemical;
          (3) has had his State license or registration 
        suspended, revoked, or denied by competent State 
        authority and is no longer authorized by State law to 
        engage in the manufacturing, distribution, or 
        dispensing of controlled substances or list I chemicals 
        or has had the suspension, revocation, or denial of his 
        registration recommended by competent State authority;
          (4) has committed such acts as would render his 
        registration under section 303 inconsistent with the 
        public interest as determined under such section; or
          (5) has been excluded (or directed to be excluded) 
        from participation in a program pursuant to section 
        1128(a) of the Social Security Act.
A registration pursuant to [section 303(g)] section 303(g)(1) 
to dispense a narcotic drug for maintenance treatment or 
detoxification treatment may be suspended or revoked by the 
Attorney General upon a finding that the registrant has failed 
to comply with any standard referred to in [section 303(g)] 
section 303(g)(1).

           *       *       *       *       *       *       *

  (d) The Attorney General may, in his discretion, suspend any 
registration simultaneously with the institution of proceedings 
under this section, in cases where he finds that there is an 
imminent danger to the public health or safety. A failure to 
comply with a standard referred to in [section 303(g)] section 
303(g)(1) may be treated under this subsection as grounds for 
immediate suspension of a registration granted under such 
section. A suspension under this subsection shall continue in 
effect until the conclusion of such proceedings, including 
judicial review thereof, unless sooner withdrawn by the 
Attorney General or dissolved by a court of competent 
jurisdiction.

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                            ADDITIONAL VIEWS

    This bill is born of a concern that potential new opiate 
addiction treatment medications will be regulated in a manner 
that will limit their availability and use. The current 
paradigm for regulation of opiate addiction medications is 
based on methadone and ORLAAM (a methadone alternative) and 
includes rigorous federal regulations as well as a variety of 
state and local restrictions.
    The only known medications that would be affected by the 
bill are buprenorphine and a combination product, 
buprenorphine/naloxone. These products have been developed 
under a Cooperative Research and Development Agreement (CRADA) 
between the National Institute on Drug Abuse (NIDA) and Reckitt 
& Colman.
    According to NIDA's Buprenorphine Update, ``[t]here are no 
current regulations which address the use of buprenorphine or 
buprenorphine/naloxone for the treatment of opiate dependence 
because these products are not yet approved for this purpose by 
the FDA.'' NIDA goes on to state that ``[t]he regulatory burden 
should be determined based on a review of the risks to 
individuals and society of this medication being dispensed by 
prescription and commensurate with its safety profile, as is 
the case with evaluation of all controlled substances.''
    The Federal agency responsible for establishing guidelines 
for opiate addiction treatment is the Substance Abuse and 
Mental Health Services Administration (SAMHSA). At a hearing on 
this legislation and in other communications on this subject, 
SAMHSA has said that it is in the process of drafting a 
proposed regulation for buprenorphine. The agency has not 
argued that the rigorous regulatory paradigm for methadone 
would be appropriate for buprenorphine. Indeed, SAMHSA has 
already published a proposal to revise the methadone 
regulations.
    The bill exempts ``qualifying physicians'' at a time when 
buprenorphine has not been approved by FDA, and therefore 
before labeling information important to its use is known. 
According to NIDA, ``[t]he safety and effectiveness profiles 
for buprenorphine and buprenorphine/naloxone suggest they could 
be dispensed under controlled circumstances that would be 
delineated in the product labeling and associated rules and 
regulations.'' It may be premature to exempt anyone from yet to 
be written regulations for a yet to be approved and labeled 
drug.
    The bill preempts state and local laws that are ``in 
conflict with'' it. The National Association of State Alcohol 
and Drug Abuse Directors (NASADAD) has stated its opposition to 
the bill's preemption language. We still do not have an 
accounting of what state and local laws will be affected by the 
preemption language of this bill.
    Finally, the bill does not provide any resources for 
patient access to buprenorphine. Although the rigor of current 
narcotic addiction treatment regulations may be a barrier to 
treatment, evidence presented at the hearing on this bill 
clearly showed that financial resources are a critical element 
of access to treatment and to development of effective 
addiction treatment medications. It is important to note that 
most persons in the treatment gap lack access to financial 
resources for treatment. Insurance coverage often does not 
provide ``parity'' for substance abuse treatment, and the 
Medicaid programs of twenty-five states do not pay for 
methadone treatment. The cost of methadone is less than one 
dollar per day. Some estimates for the daily cost of 
buprenorphine are as high as ten dollars per day. Thus, most 
heroin addicts in the treatment gap will not be able to afford 
the office based treatment contemplated by the bill.
    Buprenorphine is expected to be effective for the treatment 
of mild to moderate heroin addiction. A majority of heroin 
addicts are severely addicted. Thus, many persons who are in 
the treatment gap will not benefit from the bill for 
pharmacological reasons. Their lack of access to treatment is 
not addressed by the bill.
    In sum, the bill may ultimately help some heroin addicts to 
receive treatment, but this number will be a fraction of those 
who are in the treatment gap. These will be mild to moderately 
addicted persons with the financial resources to obtain access 
to a physician or other health care provider who will either 
dispense or prescribe the medication. The bill does not address 
the needs of most heroin addicts; namely, those who are 
severely addicted or who lack the financial resources to see a 
doctor. Some members have strongly urged the majority to 
address these aspects of the treatment gap that are not 
included in H.R. 2634. A good first step would be to move 
legislation to reauthorize the programs administered by the 
Substance Abuse and Mental Health Services Administration, 
which provide the bulk of federal resources for substance abuse 
prevention and treatment.

                                   John D. Dingell.
                                   Henry A. Waxman.
                                   Tom Barrett.
                                   Peter Deutsch.
                                   Edolphus Towns.
                                   Bill Luther.
                                   Ted Strickland.
                                   Tom Sawyer.
                                   Lois Capps.