[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1455 Reported in Senate (RS)]
<DOC>
Calendar No. 441
114th CONGRESS
2d Session
S. 1455
To provide access to medication-assisted therapy, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 22, 2015
Mr. Markey (for himself, Mr. Paul, Mrs. Feinstein, Mr. Durbin, Ms.
Hirono, Mr. Brown, Ms. Baldwin, Mr. Franken, Mr. Casey, Mrs. Shaheen,
Mr. King, Mr. Leahy, Mr. Sanders, Ms. Collins, Mr. Merkley, Mr. Reed,
Mr. Murphy, Mr. Menendez, Mr. Hatch, and Mrs. Gillibrand) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
April 27, 2016
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To provide access to medication-assisted therapy, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Recovery Enhancement for
Addiction Treatment Act'' or the ``TREAT Act''.</DELETED>
<DELETED>SEC. 2. FINDINGS.</DELETED>
<DELETED> Congress finds the following:</DELETED>
<DELETED> (1) Overdoses from opioids have increased
dramatically in the United States.</DELETED>
<DELETED> (2) Deaths from drug overdose, largely from
prescription pain relievers, have tripled among men and
increased five-fold among women over the past decade.</DELETED>
<DELETED> (3) Nationwide, drug overdoses now claim more
lives than car accidents.</DELETED>
<DELETED> (4) Opioid addiction is a chronic disease that,
untreated, places a large burden on the healthcare system.
Roughly 475,000 emergency room visits each year are
attributable to the misuse and abuse of opioid pain
medication.</DELETED>
<DELETED> (5) Effective medication-assisted treatment for
opioid addiction, in combination with counseling and behavioral
therapies, can decrease overdose deaths, be cost-effective,
reduce transmissions of HIV and viral hepatitis, and reduce
other social harms such as criminal activity.</DELETED>
<DELETED> (6) Effective medication-assisted treatment
programs for opioid addiction should include multiple
components, including medications, cognitive and behavioral
supports and interventions, and drug testing.</DELETED>
<DELETED> (7) Effective medication-assisted treatment
programs for opioid addiction may use a team of staff members,
in addition to a prescribing provider, to deliver comprehensive
care.</DELETED>
<DELETED> (8) Access to medication-assisted treatments,
including office-based buprenorphine opioid treatment, remains
limited in part due to current practice regulations and an
insufficient number of providers.</DELETED>
<DELETED> (9) More than 10 years of experience in the United
States with office-based buprenorphine opioid treatment has
informed best practices for delivering successful, high quality
care.</DELETED>
<DELETED>SEC. 3. EXPANSION OF PATIENT LIMITS UNDER WAIVER.</DELETED>
<DELETED> Section 303(g)(2)(B) of the Controlled Substances Act (21
U.S.C. 823(g)(2)(B)) is amended--</DELETED>
<DELETED> (1) in clause (i), by striking ``physician'' and
inserting ``practitioner'';</DELETED>
<DELETED> (2) in clause (iii)--</DELETED>
<DELETED> (A) by striking ``30'' and inserting
``100''; and</DELETED>
<DELETED> (B) by striking ``, unless, not sooner''
and all that follows through the end and inserting a
period; and</DELETED>
<DELETED> (3) by inserting at the end the following new
clause:</DELETED>
<DELETED> ``(iv) Not earlier than 1 year after the
date on which a qualifying practitioner obtained an
initial waiver pursuant to clause (iii), the qualifying
practitioner may submit a second notification to the
Secretary of the need and intent of the qualifying
practitioner to treat an unlimited number of patients,
if the qualifying practitioner--</DELETED>
<DELETED> ``(I)(aa) satisfies the
requirements of item (aa), (bb), (cc), or (dd)
of subparagraph (G)(ii)(I); and</DELETED>
<DELETED> ``(bb) agrees to fully participate
in the Prescription Drug Monitoring Program of
the State in which the qualifying practitioner
is licensed, pursuant to applicable State
guidelines; or</DELETED>
<DELETED> ``(II)(aa) satisfies the
requirements of item (ee), (ff), or (gg) of
subparagraph (G)(ii)(I);</DELETED>
<DELETED> ``(bb) agrees to fully participate
in the Prescription Drug Monitoring Program of
the State in which the qualifying practitioner
is licensed, pursuant to applicable State
guidelines;</DELETED>
<DELETED> ``(cc) practices in a qualified
practice setting; and</DELETED>
<DELETED> ``(dd) has completed not less than
24 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.''.</DELETED>
<DELETED>SEC. 4. DEFINITIONS.</DELETED>
<DELETED> Section 303(g)(2)(G) of the Controlled Substances Act (21
U.S.C. 823(g)(2)(G)) is amended--</DELETED>
<DELETED> (1) by striking clause (ii) and inserting the
following:</DELETED>
<DELETED> ``(ii) The term `qualifying practitioner'
means the following:</DELETED>
<DELETED> ``(I) A physician who is licensed
under State law and who meets 1 or more of the
following conditions:</DELETED>
<DELETED> ``(aa) The physician holds
a board certification in addiction
psychiatry from the American Board of
Medical Specialties.</DELETED>
<DELETED> ``(bb) The physician holds
an addiction certification from the
American Society of Addiction
Medicine.</DELETED>
<DELETED> ``(cc) The physician holds
a board certification in addiction
medicine from the American Osteopathic
Association.</DELETED>
<DELETED> ``(dd) The physician holds
a board certification from the American
Board of Addiction Medicine.</DELETED>
<DELETED> ``(ee) The physician has
completed not less than 8 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.</DELETED>
<DELETED> ``(ff) The physician has
participated as an investigator in 1 or
more clinical trials leading to the
approval of a narcotic drug in schedule
III, IV, or V for maintenance or
detoxification treatment, as
demonstrated by a statement submitted
to the Secretary by this sponsor of
such approved drug.</DELETED>
<DELETED> ``(gg) The physician has
such other training or experience as
the Secretary determines will
demonstrate the ability of the
physician to treat and manage opiate-
dependent patients.</DELETED>
<DELETED> ``(II) A nurse practitioner or
physician assistant who is licensed under State
law and meets all of the following
conditions:</DELETED>
<DELETED> ``(aa) The nurse
practitioner or physician assistant is
licensed under State law to prescribe
schedule III, IV, or V medications for
pain.</DELETED>
<DELETED> ``(bb) The nurse
practitioner or physician assistant
satisfies 1 or more of the
following:</DELETED>
<DELETED> ``(AA) Has
completed not fewer than 24
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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(cc) The nurse
practitioner or physician assistant
practices under the supervision of a
licensed physician who holds an active
waiver to prescribe schedule III, IV,
or V narcotic medications for opioid
addiction therapy, and--</DELETED>
<DELETED> ``(AA) the
supervising physician satisfies
the conditions of item (aa),
(bb), (cc), or (dd) of
subclause (I); or</DELETED>
<DELETED> ``(BB) both the
supervising physician and the
nurse practitioner or physician
assistant practice in a
qualified practice
setting.</DELETED>
<DELETED> ``(III) A nurse practitioner who
is licensed under State law and meets all of
the following conditions:</DELETED>
<DELETED> ``(aa) The nurse
practitioner is licensed under State
law to prescribe schedule III, IV, or V
medications for pain.</DELETED>
<DELETED> ``(bb) The nurse
practitioner has training or experience
that the Secretary determines
demonstrates specialization in the
ability to treat opiate-dependent
patients, such as a certification in
addiction specialty accredited by the
American Board of Nursing Specialties
or the National Commission for
Certifying Agencies, or a certification
in addiction nursing as a Certified
Addiction Registered Nurse--Advanced
Practice.</DELETED>
<DELETED> ``(cc) In accordance with
State law, the nurse practitioner
prescribes opioid addiction therapy in
collaboration with a physician who
holds an active waiver to prescribe
schedule III, IV, or V narcotic
medications for opioid addiction
therapy.</DELETED>
<DELETED> ``(dd) The nurse
practitioner practices in a qualified
practice setting.''; and</DELETED>
<DELETED> (2) by adding at the end the following:</DELETED>
<DELETED> ``(iii) The term `qualified practice
setting' means 1 or more of the following treatment
settings:</DELETED>
<DELETED> ``(I) A National Committee for
Quality Assurance-recognized Patient-Centered
Medical Home or Patient-Centered Specialty
Practice.</DELETED>
<DELETED> ``(II) A Centers for Medicaid &
Medicare Services-recognized Accountable Care
Organization.</DELETED>
<DELETED> ``(III) A clinical facility
administered by the Department of Veterans
Affairs, Department of Defense, or Indian
Health Service.</DELETED>
<DELETED> ``(IV) A Behavioral Health Home
accredited by the Joint Commission.</DELETED>
<DELETED> ``(V) A Federally-qualified health
center (as defined in section 1905(l)(2)(B) of
the Social Security Act (42 U.S.C.
1396d(l)(2)(B))) or a Federally-qualified
health center look-alike.</DELETED>
<DELETED> ``(VI) A Substance Abuse and
Mental Health Services-certified Opioid
Treatment Program.</DELETED>
<DELETED> ``(VII) A clinical program of a
State or Federal jail, prison, or other
facility where individuals are
incarcerated.</DELETED>
<DELETED> ``(VIII) A clinic that
demonstrates compliance with the Model Policy
on DATA 2000 and Treatment of Opioid Addiction
in the Medical Office issued by the Federation
of State Medical Boards.</DELETED>
<DELETED> ``(IX) A treatment setting that is
part of an Accreditation Council for Graduate
Medical Education, American Association of
Colleges of Osteopathic Medicine, or American
Osteopathic Association-accredited residency or
fellowship training program.</DELETED>
<DELETED> ``(X) Any other practice setting
approved by a State regulatory board or State
Medicaid Plan to provide addiction treatment
services.</DELETED>
<DELETED> ``(XI) Any other practice setting
approved by the Secretary.''.</DELETED>
<DELETED>SEC. 5. GAO EVALUATION.</DELETED>
<DELETED> Two 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--
</DELETED>
<DELETED> (1) any changes in the availability and use of
medication-assisted treatment for opioid addiction;</DELETED>
<DELETED> (2) the quality of medication-assisted treatment
programs;</DELETED>
<DELETED> (3) the integration of medication-assisted
treatment with routine healthcare services;</DELETED>
<DELETED> (4) diversion of opioid addiction treatment
medication;</DELETED>
<DELETED> (5) changes in State or local policies and
legislation relating to opioid addiction treatment;</DELETED>
<DELETED> (6) the use of nurse practitioners and physician
assistants who prescribe opioid addiction medication;</DELETED>
<DELETED> (7) the use of Prescription Drug Monitoring
Programs by waived practitioners to maximize safety of patient
care and prevent diversion of opioid addiction
medication;</DELETED>
<DELETED> (8) the findings of Drug Enforcement
Administration inspections of waived practitioners, including
the frequency with which the Drug Enforcement Administration
finds no documentation of access to behavioral health services;
and</DELETED>
<DELETED> (9) the effectiveness of cross-agency
collaboration between Department of Health and Human Services
and the Drug Enforcement Administration for expanding effective
opioid addiction treatment.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Recovery Enhancement for Addiction
Treatment Act'' or the ``TREAT Act''.
SEC. 2. EXPANSION OF PATIENT LIMITS UNDER WAIVER.
Section 303(g)(2)(B) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(B)) is amended--
(1) in clause (i), by striking ``physician'' and inserting
``practitioner'';
(2) in clause (iii)--
(A) by striking ``The total number'' and inserting
``(I) The total number'';
(B) by striking ``30'' and inserting ``100'';
(C) by striking ``, unless, not sooner'' and all
that follows through ``of this subparagraph''; and
(D) by adding at the end the following:
``(II) If a patient is referred by a qualifying
practitioner that is a physician to another qualifying
practitioner that is a physician that provides short-
term services (such as induction or titration), the
patient shall only be included in 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' shall not include a patient to whom a
qualifying practitioner that is a physician meeting the
requirements described in clause (iv)(I), or an
authorized agent of such qualifying practitioner that
is a physician, directly administers such drugs or
combination drugs.''; and
(4) by adding at the end the following:
``(iv) Not earlier than 1 year after the date on which a
qualifying practitioner that is a physician obtained an initial
waiver pursuant to clause (iii), such qualifying practitioner
may submit a second notification to the Secretary of the need
and intent of such qualifying practitioner to treat up to 500
patients, if such qualifying practitioner--
``(I)(aa) satisfies the requirements of item (aa), (bb),
(cc), or (dd) of subparagraph (G)(ii)(I); and
``(bb) agrees to fully participate in the Prescription Drug
Monitoring Program of the State in which the qualifying
practitioner is licensed, pursuant to applicable State
guidelines; or
``(II)(aa) satisfies the requirements of item (ee), (ff),
or (gg) of subparagraph (G)(ii)(I);
``(bb) agrees to fully participate in the Prescription Drug
Monitoring Program of the State in which the qualifying
practitioner is licensed, pursuant to applicable State
guidelines; and
``(cc) has completed not less than 24 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.
``(v) The qualifying practitioner shall maintain records
relating to the dispensing of drugs or combinations of drugs to
treat patients under this paragraph, including--
``(I) whether the qualifying practitioner provides
counseling services on-site, and how frequently
patients are using such services;
``(II) whether the qualifying practitioner referred
patients for counseling services off-site, the
percentage of the patients of the qualifying
practitioner using such services, and how frequently
the patients are using such services; and
``(III) the frequency with which patients being
treated under this paragraph terminate the treatment
against medical advice.''.
SEC. 3. DEFINITIONS.
Section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)) is amended by striking clause (ii) and inserting the
following:
``(ii) The term `qualifying practitioner' means the
following:
``(I) A physician who is licensed under
State law and who meets 1 or more of the
following conditions:
``(aa) The physician holds a board
certification in addiction psychiatry
or addiction medicine from the American
Board of Medical Specialties.
``(bb) The physician holds an
addiction certification from the
American Society of Addiction Medicine
or the American Board of Addiction
Medicine.
``(cc) The physician holds a board
certification in addiction medicine
from the American Osteopathic
Association.
``(dd) The physician holds a board
certification from the American Board
of Addiction Medicine.
``(ee) The physician has completed
not less than 8 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 notice and the
opportunity for comment.
``(ff) The physician has
participated as an investigator in 1 or
more clinical trials leading to the
approval of a narcotic drug in schedule
III, IV, or V for maintenance or
detoxification treatment, as
demonstrated by a statement submitted
to the Secretary by this sponsor of
such approved drug.
``(gg) The physician has such other
training or experience as the Secretary
determines will demonstrate the ability
of the physician to treat and manage
opiate dependent patients.
``(II) A nurse practitioner or physician
assistant who is licensed under State law and
meets all of the following conditions:
``(aa) The nurse practitioner or
physician assistant is licensed under
State law to prescribe schedule III,
IV, or V medications.
``(bb) The nurse practitioner or
physician assistant has completed not
fewer than 24 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, 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, after notice and
opportunity for comment.
``(cc) If required by State law,
the nurse practitioner or physician
assistant prescribes opioid addiction
therapy in collaboration with or under
the supervision of, as applicable, a
physician.''.
SEC. 4. STATE FLEXIBILITY.
Section 303(g)(2) of the Controlled Substances Act (21 U.S.C.
823(g)(2)) is amended by striking subparagraphs (I) and (J), and
inserting the following:
``(I) Notwithstanding section 708, nothing in this
paragraph shall be construed to preempt any State law that--
``(i) permits a qualifying practitioner to dispense
narcotic drugs in schedule III, IV, or V, or
combinations of such drugs, for maintenance or
detoxification treatment in accordance with this
paragraph to a total number of patients that is more
than 30 or less than the total number applicable to the
qualifying practitioner under clause (iv) of
subparagraph (B) if a State enacts a law modifying such
total number and the Attorney General is notified by
the State of such modification; or
``(ii) requires a qualifying practitioner 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 practitioner practices and education,
training, and reporting requirements.''.
SEC. 5. UPDATE REGULATIONS.
Not later than 1 year after the date of enactment of this Act, the
Attorney General shall update regulations regarding waived
practitioners (as amended by this Act) to include nurse practitioners
and physician assistants to ensure the quality of patient care and
prevent diversion.
SEC. 6. 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, including the impact of nurse practitioners and physician
assistants as qualifying practitioners.
(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).
Calendar No. 441
114th CONGRESS
2d Session
S. 1455
_______________________________________________________________________
A BILL
To provide access to medication-assisted therapy, and for other
purposes.
_______________________________________________________________________
April 27, 2016
Reported with an amendment