S.Amdt. 3426

SA 3426. Mr. PAUL submitted an amendment intended to be proposed to
amendment SA 3378 proposed by Mr. Grassley (for himself, Mr. Leahy, Mr.
Whitehouse, Mr. Portman, Ms. Klobuchar, Ms. Ayotte, Mr. Graham, Mr.
Coons, Mr. Cornyn, and Mr. Durbin) to the bill S. 524, to authorize the
Attorney General to award grants to address the national epidemics of
prescription opioid abuse and heroin use; which was ordered to lie on
the table; as follows:

At the end, add the following:

TITLE VIII--ACCESS TO MEDICATION-ASSISTED THERAPY

SEC. 801. EXPANDING PATIENT ACCESS TO MEDICATION-ASSISTED
TREATMENT.

Section 303(g)(2) of the Controlled Substances Act (21
U.S.C. 823(g)) is amended--
(1) in subparagraph (B)--
(A) in clause (iii)--
(i) by inserting ``(I)'' before ``The total'';
(ii) by striking ``30'' and inserting ``100'';
(iii) by striking ``, unless, not sooner'' and all that
follows through the end and inserting a period; and
(iv) by adding at the end the following:
``(II) If a patient is referred by a qualifying physician
to another physician that provides short-term services, such
as induction or titration, the patient shall only be included
in

[[Page S1287]]

the total number of such patients of the qualifying physician
that makes the referral.
``(III) In this clause, the term `the total number of such
patients' does not include a patient to whom a qualifying
physician meeting the requirements described in clause
(iv)(I), or an authorized agent of such qualifying physician,
directly administers such drugs or combination drugs that are
formulated to have a therapeutic effect lasting 7 days or
more.''; and
(B) by adding at the end the following:
``(iv) Not earlier than 1 year after the date on which a
qualifying physician obtained an initial waiver pursuant to
clause (iii), the qualifying physician may submit a second
notification to the Secretary of the need and intent of the
qualifying physician to treat up to 500 patients, if the
qualifying physician--
``(I)(aa) satisfies the requirements of subclause (I),
(II), (III), or (IV) of subparagraph (G)(ii); and
``(bb) agrees to fully participate in the Prescription Drug
Monitoring Program of the State in which the qualifying
physician is licensed, pursuant to applicable State
guidelines; or
``(II)(aa) satisfies the requirements of subclause (V),
(VI), (VII), or (VIII) of subparagraph (G)(ii);
``(bb) agrees to fully participate in the Prescription Drug
Monitoring Program of the State in which the qualifying
physician is licensed, pursuant to applicable State
guidelines; and
``(cc) has completed not less than 40 hours of training
(through classroom situations, seminars at professional
society meetings, electronic communications, or otherwise)
with respect to the treatment and management of opiate-
dependent patients for substance use disorders 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 after providing notice and an opportunity for
public comment.
``(v) The qualifying physician shall maintain records
relating to the dispensing of drugs or combinations of drugs
to treat patients under this paragraph, including not less
than 3 of the following:
``(I) The number of patients the qualifying physician
treats, as compared to the maximum number of patients the
qualifying physician may treat under this paragraph.
``(II) Whether the qualifying physician provides counseling
services on-site, and how frequently patients are using such
services.
``(III) Whether the qualifying physician referred patients
for counseling services off-site, the percentage of the
patients of the qualifying physician using such services, and
how frequently the patients are using such services.
``(IV) Whether the qualifying physician uses toxicology
testing, if applicable, to guide therapeutic dosing and
treatment decision making.
``(V) The median period during which patients being treated
under this paragraph have received treatment.
``(VI) The median period during which patients being
treated under this paragraph with buprenorphine have received
treatment.
``(VII) The rate at which patients being treated under this
paragraph terminate the treatment against medical advice.
``(vi) The qualifying physician shall--
``(I) participate in not less than 24 hours of continuing
education training during the 3-year period beginning on the
date of the notification; and
``(II) when the qualifying physician completes the
continuing education training described in subclause (I),
submit a certification to that effect to the Substance Abuse
and Mental Health Services Administration and, if required by
the State in which the qualifying physician is licensed, to
the State.''; and
(2) by adding at the end the following:
``(K) Notwithstanding section 708, nothing in this
paragraph shall be construed to preempt any State law that--
``(i) permits a qualifying physician to dispense narcotic
drugs in schedule III, IV, or V or combinations of such drugs
to a total number of patients for maintenance or
detoxification treatment in accordance with this paragraph
that is fewer than or more than the applicable number
described in clause (iii) or (iv) of subparagraph (B); or
``(ii) requires a qualifying physician to comply with
additional requirements relating to the dispensing of
narcotic drugs in schedule III, IV, or V or combinations of
such drugs, including requirements relating to the practice
setting in which the qualifying physician practices and
education, training, and reporting requirements.''.

SEC. 802. DEFINITIONS.

Section 303(g)(2)(G)(ii) of the Controlled Substances Act
(21 U.S.C. 823(g)(2)(G)(ii)) is amended--
(1) by redesignating subclauses (IV), (V), (VI), and (VII)
as subclauses (V), (VI), (VII), and (VIII), respectively; and
(2) by inserting after subclause (III) the following:
``(IV) The physician holds a board certification from the
American Board of Addiction Medicine.''.

SEC. 803. EVALUATIONS.

(a) Definition.--In this section, the term ``appropriate
committees of Congress'' means--
(1) the Committee on Health, Education, Labor, and Pensions
and the Committee on the Judiciary of the Senate; and
(2) the Committee on Energy and Commerce and the Committee
on the Judiciary of the House of Representatives.
(b) HHS.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human
Services, in coordination with the Attorney General, shall
submit to the appropriate committees of Congress a report on
the effect on the amendments made by this title on the
availability of evidence-based treatment and any increased
risk in diversion.
(c) GAO.--
(1) In general.--Four years after the date on which the
first notification under clause (iv) of section 303(g)(2)(B)
of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)), as
added by this Act, is received by the Secretary of Health and
Human Services, the Comptroller General of the United States
shall initiate an evaluation of the effectiveness of the
amendments made by this Act, which shall include an
evaluation of--
(A) any changes in the availability and use of medication-
assisted treatment for opioid addiction;
(B) the quality of medication-assisted treatment programs;
(C) the integration of medication-assisted treatment with
routine healthcare services;
(D) diversion of opioid addiction treatment medication;
(E) changes in State or local policies and legislation
relating to opioid addiction treatment;
(F) the use of nurse practitioners and physician assistants
who prescribe opioid addiction medication;
(G) the use of Prescription Drug Monitoring Programs by
waived practitioners to maximize safety of patient care and
prevent diversion of opioid addiction medication;
(H) the findings of Drug Enforcement Agency inspections of
waived practitioners, including the frequency with which the
Drug Enforcement Agency finds no documentation of access to
behavioral health services; and
(I) the effectiveness of cross-agency collaboration between
Department of Health and Human Services and the Drug
Enforcement Agency for expanding effective opioid addiction
treatment.
(2) Report.--The Comptroller General shall submit to the
appropriate committees of Congress a report regarding the
evaluation conducted under paragraph (1).

SEC. 804. DEMONSTRATION PROJECT.

Section 303(g)(2) of the Controlled Substances Act (21
U.S.C. 823(g)(2)), as amended by section 801(2), is amended
by adding at the end the following:
``(L)(i) In this subparagraph, the term `covered provider'
includes a person that--
``(I) is not a physician; and
``(II) is authorized to dispense narcotic drugs in schedule
III, IV, or V or combinations of such drugs for maintenance
or detoxification treatment by the jurisdiction in which the
provider is licensed.
``(ii) Notwithstanding subparagraph (B)(i), the Secretary
may establish and carry out a demonstration project for the
purposes of allowing each covered provider participating in
the demonstration project to dispense narcotic drugs in
schedule III, IV, or V or combinations of such drugs for
maintenance or detoxification treatment under this
paragraph--
``(I) during an initial period, to be determined by the
Secretary, to treat not more than 30 patients; and
``(II) after the initial period, to treat not more than 100
patients.
``(iii) The Secretary may enter into grants, contracts, or
cooperative agreements with 1 or more research institutions,
departments of health of a State, and public and nonprofit
entities to assist in carrying out the demonstration project
under this subparagraph.
``(iv) Amounts made available to the Attorney General for
carrying out this section or to the Secretary of Health and
Human Services for carrying out title V of the Public Health
Service Act (42 U.S.C. 290aa) shall also be made available to
carry out the demonstration project under this subparagraph.
``(v) The demonstration project under this subparagraph,
including any authority to dispense narcotic drugs in
schedule III, IV, or V or combinations of such drugs for
maintenance or detoxification treatment under this
subparagraph, shall terminate on September 30, 2021.''.
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