[Congressional Record Volume 162, Number 33 (Tuesday, March 1, 2016)]
[Senate]
[Pages S1165-S1166]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 3381. Mr. MARKEY (for himself and Mr. Paul) submitted an amendment
intended to be proposed by him 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--TREAT ACT
SEC. 801. SHORT TITLE.
This title may be cited as the ``Recovery Enhancement for
Addiction Treatment Act'' or the ``TREAT Act''.
SEC. 802. FINDINGS.
Congress finds the following:
(1) Overdoses from opioids have increased dramatically in
the United States.
(2) Deaths from drug overdose, largely from prescription
pain relievers, have tripled among men and increased five-
fold among women over the past decade.
(3) Nationwide, drug overdoses now claim more lives than
car accidents.
(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.
(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.
(6) Effective medication-assisted treatment programs for
opioid addiction should include multiple components,
including medications, cognitive and behavioral supports and
interventions, and drug testing.
(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.
(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.
(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.
SEC. 803. 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 ``30'' and inserting ``100''; and
(B) by striking ``, unless, not sooner'' and all that
follows through the end and inserting a period; and
(3) by inserting at the end the following new clause:
``(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--
``(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;
``(cc) practices in a qualified practice setting; and
``(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.''.
SEC. 804. DEFINITIONS.
Section 303(g)(2)(G) of the Controlled Substances Act (21
U.S.C. 823(g)(2)(G)) is amended--
(1) 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 from the American Board of Medical
Specialties.
``(bb) The physician holds an addiction certification from
the American Society 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.
``(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 for pain.
``(bb) The nurse practitioner or physician assistant
satisfies 1 or more of the following:
``(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
[[Page S1166]]
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.
``(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.
``(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--
``(AA) the supervising physician satisfies the conditions
of item (aa), (bb), (cc), or (dd) of subclause (I); or
``(BB) both the supervising physician and the nurse
practitioner or physician assistant practice in a qualified
practice setting.
``(III) A nurse practitioner who is licensed under State
law and meets all of the following conditions:
``(aa) The nurse practitioner is licensed under State law
to prescribe schedule III, IV, or V medications for pain.
``(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.
``(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.
``(dd) The nurse practitioner practices in a qualified
practice setting.''; and
(2) by adding at the end the following:
``(iii) The term `qualified practice setting' means 1 or
more of the following treatment settings:
``(I) A National Committee for Quality Assurance-recognized
Patient-Centered Medical Home or Patient-Centered Specialty
Practice.
``(II) A Centers for Medicaid & Medicare Services-
recognized Accountable Care Organization.
``(III) A clinical facility administered by the Department
of Veterans Affairs, Department of Defense, or Indian Health
Service.
``(IV) A Behavioral Health Home accredited by the Joint
Commission.
``(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.
``(VI) A Substance Abuse and Mental Health Services-
certified Opioid Treatment Program.
``(VII) A clinical program of a State or Federal jail,
prison, or other facility where individuals are incarcerated.
``(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.
``(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.
``(X) Any other practice setting approved by a State
regulatory board or State Medicaid Plan to provide addiction
treatment services.
``(XI) Any other practice setting approved by the
Secretary.''.
SEC. 805. GAO EVALUATION.
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
title, 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 title, which shall include an evaluation of--
(1) any changes in the availability and use of medication-
assisted treatment for opioid addiction;
(2) the quality of medication-assisted treatment programs;
(3) the integration of medication-assisted treatment with
routine healthcare services;
(4) diversion of opioid addiction treatment medication;
(5) changes in State or local policies and legislation
relating to opioid addiction treatment;
(6) the use of nurse practitioners and physician assistants
who prescribe opioid addiction medication;
(7) the use of Prescription Drug Monitoring Programs by
waived practitioners to maximize safety of patient care and
prevent diversion of opioid addiction medication;
(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
(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.
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