[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4981 Referred in Senate (RFS)]
<DOC>
114th CONGRESS
2d Session
H. R. 4981
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 12, 2016
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
To amend the Controlled Substances Act to improve access to opioid use
disorder treatment.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Opioid Use Disorder Treatment
Expansion and Modernization Act''.
SEC. 2. FINDING.
The Congress finds that opioid use disorder has become a public
health epidemic that must be addressed by increasing awareness and
access to all treatment options for opioid use disorder, overdose
reversal, and relapse prevention.
SEC. 3. OPIOID USE DISORDER TREATMENT MODERNIZATION.
(a) In General.--Section 303(g)(2) of the Controlled Substances Act
(21 U.S.C. 823(g)(2)) is amended--
(1) in subparagraph (B), by striking clauses (i), (ii), and
(iii) and inserting the following:
``(i) The practitioner is a qualifying practitioner (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 provide directly, by referral,
or in such other manner as determined by the Secretary--
``(I) all schedule III, IV, and V drugs, as well as
unscheduled medications approved by the Food and Drug
Administration, for the treatment of opioid use
disorder, including such drugs and medications for
maintenance, detoxification, overdose reversal, and
relapse prevention, as available; and
``(II) appropriate counseling and other appropriate
ancillary services.
``(iii)(I) The total number of such patients of the
practitioner at any one time will not exceed the applicable
number. Except as provided in subclause (II), the applicable
number is 30.
``(II) The applicable number is 100 if, not sooner than 1
year after the date on which the practitioner submitted the
initial notification, the practitioner submits a second
notification to the Secretary of the need and intent of the
practitioner to treat up to 100 patients.
``(III) The Secretary may by regulation change such total
number.
``(IV) The Secretary may exclude from the applicable number
patients to whom such drugs or combinations of drugs are
directly administered by the qualifying practitioner in the
office setting.
``(iv) If the Secretary by regulation increases the total
number of patients which a qualifying practitioner is permitted
to treat pursuant to clause (iii)(II), the Secretary shall
require such a practitioner to obtain a written agreement from
each patient, including the patient's signature, that the
patient--
``(I) will receive an initial assessment and
treatment plan and periodic assessments and treatment
plans thereafter;
``(II) will be subject to medication adherence and
substance use monitoring;
``(III) understands available treatment options,
including all drugs approved by the Food and Drug
Administration for the treatment of opioid use
disorder, including their potential risks and benefits;
and
``(IV) understands that receiving regular
counseling services is critical to recovery.
``(v) The practitioner will comply with the reporting
requirements of subparagraph (D)(i)(IV).'';
(2) in subparagraph (D)--
(A) in clause (i), by adding at the end the
following:
``(IV) The practitioner reports to the Secretary, at such
times and in such manner as specified by the Secretary, such
information and assurances as the Secretary determines
necessary to assess whether the practitioner continues to meet
the requirements for a waiver under this paragraph.'';
(B) in clause (ii), by striking ``Upon receiving a
notification under subparagraph (B)'' and inserting
``Upon receiving a determination from the Secretary
under clause (iii) finding that a practitioner meets
all requirements for a waiver under subparagraph (B)'';
and
(C) in clause (iii)--
(i) by inserting ``and shall forward such
determination to the Attorney General'' before
the period at the end of the first sentence;
and
(ii) by striking ``physician'' and
inserting ``practitioner'';
(3) in subparagraph (G)--
(A) by amending clause (ii)(IV) to read as follows:
``(IV) The physician has, with respect to the
treatment and management of opiate-dependent patients,
completed not less than 8 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. Such training shall address--
``(aa) opioid maintenance and
detoxification;
``(bb) appropriate clinical use of all
drugs approved by the Food and Drug
Administration for the treatment of opioid use
disorder;
``(cc) initial and periodic patient
assessments (including substance use
monitoring);
``(dd) individualized treatment planning;
overdose reversal; relapse prevention;
``(ee) counseling and recovery support
services;
``(ff) staffing roles and considerations;
``(gg) diversion control; and
``(hh) other best practices, as identified
by the Secretary.''; and
(B) by adding at the end the following:
``(iii) The term `qualifying practitioner' means--
``(I) a qualifying physician, as defined in clause
(ii); or
``(II) during the period beginning on the date of
the enactment of the Opioid Use Disorder Treatment
Expansion and Modernization Act and ending on the date
that is 3 years after such date of enactment, a
qualifying other practitioner, as defined in clause
(iv).
``(iv) The term `qualifying other practitioner' means a
nurse practitioner or physician assistant who satisfies each of
the following:
``(I) The nurse practitioner or physician assistant
is licensed under State law to prescribe schedule III,
IV, or V medications for the treatment of pain.
``(II) The nurse practitioner or physician
assistant satisfies one or more of the following:
``(aa) Has completed not fewer than 24
hours of initial training addressing each of
the topics listed in clause (ii)(IV) (through
classroom situations, seminars at professional
society meetings, electronic communications, or
otherwise) provided by the American Society of
Addiction Medicine, the American Academy of
Addiction Psychiatry, the American Medical
Association, the American Osteopathic
Association, the American Nurses Credentialing
Center, the American Psychiatric Association,
the American Association of Nurse
Practitioners, the American Academy of
Physician Assistants, or any other organization
that the Secretary determines is appropriate
for purposes of this subclause.
``(bb) Has such other training or
experience as the Secretary determines will
demonstrate the ability of the nurse
practitioner or physician assistant to treat
and manage opiate-dependent patients.
``(III) The nurse practitioner or physician
assistant is supervised by or works in collaboration
with a qualifying physician, if the nurse practitioner
or physician assistant is required by State law to
prescribe medications for the treatment of opioid use
disorder in collaboration with or under the supervision
of a physician.
The Secretary may review and update the requirements for being
a qualifying other practitioner under this clause.''; and
(4) in subparagraph (H)--
(A) in clause (i), by inserting after subclause
(II) the following:
``(III) Such other elements of the requirements under this
paragraph as the Secretary determines necessary for purposes of
implementing such requirements.''; and
(B) by amending clause (ii) to read as follows:
``(ii) Not later than 1 year after the date of enactment of the
Opioid Use Disorder Treatment Expansion and Modernization Act, the
Secretary shall update the treatment improvement protocol containing
best practice guidelines for the treatment of opioid-dependent patients
in office-based settings. The Secretary shall update such protocol in
consultation with experts in opioid use disorder research and
treatment.''.
(b) Recommendation of Revocation or Suspension of Registration in
Case of Substantial Noncompliance.--The Secretary of Health and Human
Services may recommend to the Attorney General that the registration of
a practitioner be revoked or suspended if the Secretary determines,
according to such criteria as the Secretary establishes by regulation,
that a practitioner who is registered under section 303(g)(2) of the
Controlled Substances Act (21 U.S.C. 823(g)(2)) is not in substantial
compliance with the requirements of such section, as amended by this
Act.
(c) Opioid Defined.--Section 102(18) of the Controlled Substances
Act (21 U.S.C. 802(18)) is amended by inserting ``or `opioid''' after
``The term `opiate'''.
(d) Reports to Congress.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act and not less than over every 5 years
thereafter, the Secretary of Health and Human Services, in
consultation with the Drug Enforcement Administration and
experts in opioid use disorder research and treatment, shall--
(A) perform a thorough review of the provision of
opioid use disorder treatment services in the United
States, including services provided in opioid treatment
programs and other specialty and nonspecialty settings;
and
(B) submit a report to the Congress on the findings
and conclusions of such review.
(2) Contents.--Each report under paragraph (1) shall
include an assessment of--
(A) compliance with the requirements of section
303(g)(2) of the Controlled Substances Act (21 U.S.C.
823(g)(2)), as amended by this Act;
(B) the measures taken by the Secretary of Health
and Human Services to ensure such compliance;
(C) whether there is further need to increase or
decrease the number of patients a waivered practitioner
is permitted to treat, as provided for by the amendment
made by subsection (a)(1);
(D) the extent to which, and proportions with
which, the full range of Food and Drug Administration-
approved treatments for opioid use disorder are used in
routine health care settings and specialty substance
use disorder treatment settings;
(E) access to, and use of, counseling and recovery
support services, including the percentage of patients
receiving such services;
(F) changes in State or local policies and
legislation relating to opioid use disorder treatment;
(G) the use of prescription drug monitoring
programs by practitioners who are permitted to dispense
narcotic drugs to individuals pursuant to a waiver
under section 303(g)(2) of the Controlled Substances
Act (21 U.S.C. 823(g)(2));
(H) the findings resulting from inspections by the
Drug Enforcement Administration of practitioners
described in subparagraph (G); and
(I) the effectiveness of cross-agency collaboration
between Department of Health and Human Services and the
Drug Enforcement Administration for expanding effective
opioid use disorder treatment.
SEC. 4. SENSE OF CONGRESS.
It is the Sense of Congress that, with respect to the total number
of patients that a qualifying physician (as defined in subparagraph
(G)(iii) of section 303(g)(2) of the Controlled Substances Act (21
U.S.C. 823(g)(2)) can treat at any one time pursuant to such section,
the Secretary of Health and Human Services should consider raising such
total number to 250 patients following a third notification to the
Secretary of the need and intent of the physician to treat up to 250
patients that is submitted to the Secretary not sooner than 1 year
after the date on which the physician submitted to the Secretary a
second notification to treat up to 100 patients.
SEC. 5. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES.
(a) In General.--Section 309 of the Controlled Substances Act (21
U.S.C. 829) is amended by adding at the end the following:
``(f) Partial Fills of Schedule II Controlled Substances.--
``(1) Partial fills.--
``(A) In general.--A prescription for a controlled
substance in schedule II may be partially filled if--
``(i) it is not prohibited by State law;
``(ii) the prescription is written and
filled in accordance with the Controlled
Substances Act (21 U.S.C. 801 et seq.),
regulations prescribed by the Attorney General,
and State law;
``(iii) the partial fill is requested by
the patient or the practitioner that wrote the
prescription; and
``(iv) the total quantity dispensed in all
partial fillings does not exceed the total
quantity prescribed.
``(B) Other circumstances.--A prescription for a
controlled substance in schedule II may be partially
filled in accordance with section 1306.13 of title 21,
Code of Federal Regulations (as in effect on the date
of enactment of the Reducing Unused Medications Act of
2016).
``(2) Remaining portions.--
``(A) In general.--Except as provided in
subparagraph (B), remaining portions of a partially
filled prescription for a controlled substance in
schedule II--
``(i) may be filled; and
``(ii) shall be filled not later than 30
days after the date on which the prescription
is written.
``(B) Emergency situations.--In emergency
situations, as described in subsection (a), the
remaining portions of a partially filled prescription
for a controlled substance in schedule II--
``(i) may be filled; and
``(ii) shall be filled not later than 72
hours after the prescription is issued.''.
(b) Rule of Construction.--Nothing in this section shall be
construed to affect the authority of the Attorney General to allow a
prescription for a controlled substance in schedule III, IV, or V of
section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to
be partially filled.
Passed the House of Representatives May 11, 2016.
Attest:
KAREN L. HAAS,
Clerk.