[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 636 Introduced in Senate (IS)]
114th CONGRESS
1st Session
S. 636
To reduce prescription drug misuse and abuse.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 3, 2015
Mr. Udall introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To reduce prescription drug misuse and abuse.
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 ``Increasing the Safety of
Prescription Drug Use Act of 2015''.
TITLE I--HHS PROGRAMS
SEC. 101. AMENDMENT TO PURPOSE.
Paragraph (1) of section 2 of the National All Schedules
Prescription Electronic Reporting Act of 2005 (Public Law 109-60) is
amended to read as follows:
``(1) foster the establishment of State-administered
controlled substance monitoring systems in order to ensure
that--
``(A) health care providers have access to the
accurate, timely prescription history information that
they may use as a tool for the early identification of
patients at risk for addiction in order to initiate
appropriate medical interventions and avert the tragic
personal, family, and community consequences of
untreated addiction; and
``(B) appropriate law enforcement, regulatory, and
State professional licensing authorities have access to
prescription history information for the purposes of
investigating drug diversion and prescribing and
dispensing practices of errant prescribers or
pharmacists; and''.
SEC. 102. PRESCRIPTION DRUG MONITORING PROGRAM.
(a) Controlled Substance Monitoring Program.--Section 399O of the
Public Health Service Act (42 U.S.C. 280g-3) is amended--
(1) in subsection (a)(1)--
(A) in subparagraph (A), by striking ``or'';
(B) in subparagraph (B), by striking the period at
the end and inserting ``; or''; and
(C) by adding at the end the following:
``(C) to maintain and operate an existing State-
controlled substance monitoring program.'';
(2) by amending subsection (b) to read as follows:
``(b) Minimum Requirements.--The Secretary shall maintain and, as
appropriate, supplement or revise (after publishing proposed additions
and revisions in the Federal Register and receiving public comments
thereon) minimum requirements for criteria to be used by States for
purposes of clauses (ii), (v), (vi), and (vii) of subsection
(c)(1)(A).'';
(3) in subsection (c)--
(A) in paragraph (1)(B)--
(i) in the matter preceding clause (i), by
striking ``(a)(1)(B)'' and inserting
``(a)(1)(B) or (a)(1)(C)'';
(ii) in clause (i), by striking ``program
to be improved'' and inserting ``program to be
improved or maintained'';
(iii) by redesignating clauses (iii) and
(iv) as clauses (iv) and (v), respectively;
(iv) by inserting after clause (ii), the
following:
``(iii) a plan to apply the latest advances
in health information technology in order to
incorporate prescription drug monitoring
program data directly into the workflow of
prescribers and dispensers to ensure timely
access to patients' controlled prescription
drug history;'';
(v) in clause (iv) (as so redesignated), by
inserting before the semicolon the following:
``and at least one health information
technology system such as electronic health
records, health information exchanges, and e-
prescribing systems''; and
(vi) in clause (v) (as so redesignated), by
striking ``public health'' and inserting
``public health or public safety'';
(B) in paragraph (3)--
(i) by striking ``If a State that submits''
and inserting the following:
``(A) In general.--If a State that submits'';
(ii) by inserting before the period at the
end ``and include timelines for full
implementation of such interoperability. The
State shall also describe the manner in which
it will achieve interoperability between its
monitoring program and health information
technology systems, as allowable under State
law, and include timelines for the
implementation of such interoperability''; and
(iii) by adding at the end the following:
``(B) Monitoring of efforts.--The Secretary shall
monitor State efforts to achieve interoperability, as
described in subparagraph (A).'';
(C) in paragraph (5)--
(i) by striking ``implement or improve''
and inserting ``establish, improve, or
maintain''; and
(ii) by adding at the end the following:
``The Secretary shall redistribute any funds
that are so returned among the remaining
grantees under this section in accordance with
the formula described in subsection
(a)(2)(B).'';
(4) in subsection (d)--
(A) in the matter preceding paragraph (1)--
(i) by striking ``In implementing or
improving'' and all that follows through
``(a)(1)(B)'' and inserting ``In establishing,
improving, or maintaining a controlled
substance monitoring program under this
section, a State shall comply, or with respect
to a State that applies for a grant under
subparagraph (B) or (C) of subsection (a)(1)'';
and
(ii) by striking ``public health'' and
inserting ``public health or public safety'';
and
(B) by adding at the end the following:
``(5) The State shall report on interoperability with the
controlled substance monitoring program of Federal agencies,
where appropriate, interoperability with health information
technology systems such as electronic health records, health
information exchanges, and e-prescribing, where appropriate,
and whether or not the State provides automatic, real-time or
daily information about a patient when a practitioner (or the
designee of a practitioner, where permitted) requests
information about such patient.'';
(5) in subsection (e), by adding at the end the following:
``(5) The State shall--
``(A) ensure that the database--
``(i) is interoperable with the controlled
substance monitoring program of other States
and other Federal agencies and across
appropriate State agencies, including health
agencies, as determined by the Secretary;
``(ii) is interoperable with electronic
health records and e-prescribing, where
appropriate; and
``(iii) provides automatic, real-time or
daily information about a patient when a
practitioner (or the designee of a
practitioner, where permitted) requests
information about such patient;
``(B) require practitioners to use State database
information to help determine whether to prescribe or
renew a prescription for a controlled substance; and
``(C) require dispensers, or their designees, where
permitted, to enter data required by the Secretary,
including the name of the patient, the date, and
prescription dose, into the database for a controlled
substance.
``(6) Notwithstanding section 543 and any other provision
of law, the data required to be entered under paragraph (5)(C)
shall include information with respect to methadone that is
dispensed to a patient, if applicable.
``(7) The State shall ensure that--
``(A) any person who receives patient information
through the database may disclose and use such
information only to carry out the official duties of
that person with regard to the patient; and
``(B) notwithstanding subsection (f)(1)(B), no
information kept in accordance with a database
established, improved, or maintained through a grant
under this section may be used to conduct a criminal
investigation or substantiate any criminal charges
against a patient or to conduct any investigation of a
patient relating to methadone use of the patient.'';
(6) in subsections (e), (f)(1), and (g), by striking
``implementing or improving'' each place it appears and
inserting ``establishing, improving, or maintaining'';
(7) in subsection (f)--
(A) in paragraph (1)(B) by striking ``misuse of a
schedule II, III, or IV substance'' and inserting
``misuse of a controlled substance included in schedule
II, III, or IV of section 202(c) of the Controlled
Substance Act''; and
(B) by adding at the end the following:
``(3) Evaluation and reporting.--Subject to subsection (g),
a State receiving a grant under subsection (a) shall provide
the Secretary with aggregate data and other information
determined by the Secretary to be necessary to enable the
Secretary--
``(A) to evaluate the success of the State's
program in achieving its purposes; or
``(B) to prepare and submit the report to Congress
required by subsection (k)(2).
``(4) Research by other entities.--A department, program,
or administration receiving nonidentifiable information under
paragraph (1)(D) may make such information available to other
entities for research purposes.'';
(8) by striking subsection (k);
(9) by redesignating subsections (h) through (j) as
subsections (i) through (k), respectively;
(10) in subsections (c)(1)(A)(iv) and (d)(4), by striking
``subsection (h)'' each place it appears and inserting
``subsection (i)'';
(11) by inserting after subsection (g) the following:
``(h) Education and Access to the Monitoring System.--A State
receiving a grant under subsection (a) shall take steps to--
``(1) facilitate prescriber and dispenser use of the
State's controlled substance monitoring system; and
``(2) educate prescribers and dispenser on the benefits of
the system both to them and society.'';
(12) in subsection (k)(2)(A), as redesignated--
(A) in clause (ii), by striking ``or affected'' and
inserting ``, established or strengthened initiatives
to ensure linkages to substance use disorder services,
or affected''; and
(B) in clause (iii), by striking ``including an
assessment'' and inserting ``between controlled
substance monitoring programs and health information
technology systems, and including an assessment'';
(13) in subsection (l)(1), by striking ``establishment,
implementation, or improvement'' and inserting ``establishment,
improvement, or maintenance'';
(14) in subsection (m)(8), by striking ``and the District
of Columbia'' and inserting ``, the District of Columbia, and
any commonwealth or territory of the United States''; and
(15) by amending subsection (n), to read as follows:
``(o) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $7,000,000 for each of fiscal
years 2016 through 2020.''.
(b) Confidentiality of Records.--Section 543(a) of the Public
Health Service Act (42 U.S.C. 290dd-2(a)) is amended by inserting ``or,
with respect to methadone, as required under section 399O(e)(6)''
before the period at the end.
(c) Requirements for Federal Health Care Programs.--Health care
practitioners (as defined in paragraph (7) of section 399O(m) of the
Public Health Service Act (42 U.S.C. 280g-3(m))) and dispensers (as
defined in paragraph (4) of such section) who participate in or are
employed by a Federal health care program or federally funded health
care program, including the Indian Health Service, the Department of
Veterans Affairs, the Department of Defense, the Federal Bureau of
Prisons, the Medicare program under title XVIII of the Social Security
Act (42 U.S.C. 1395 et seq.), a State Medicaid plan under title XIX of
the Social Security Act (42 U.S.C. 1396 et seq.), the Children's Health
Insurance Program under title XXI of the Social Security Act (42 U.S.C.
1397aa et seq.), and Federally qualified health centers, shall use the
databases of the controlled substance monitoring programs under section
399O of the Public Health Service Act (42 U.S.C. 280g-3), if such
databases are available to the practitioner or dispenser.
SEC. 103. PILOT PROJECT.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall award grants
to one or more States to carry out a 1-year pilot project to develop a
standardized peer review process and methodology to review and evaluate
prescribing and pharmacy dispensing patterns, through a review of
prescription drug monitoring programs (referred to in this section as
``PDMP'') in the States receiving such grants.
(b) Methodology.--The recipients of a grant under this section
shall develop a systematic, standardized methodology to identify and
investigate questionable or inappropriate prescribing and dispensing
patterns of substances on schedule II or III under section 202 of the
Controlled Substances Act (21 U.S.C. 812). Such peer review methodology
and prescribing and dispensing patterns shall be shared with the
appropriate State health profession board.
(c) Requirements.--A State receiving a grant under this section--
(1) with respect to controlled substances for which a
prescriber is required to have a license issued by the Drug
Enforcement Administration in order to prescribe such
controlled substances, shall make the information with respect
to such controlled substances from the PDMP available to State
regulation and licensing boards; and
(2) with respect to any other controlled substances, may
make the information with respect to such controlled substances
from the PDMP available to State regulation and licensing
boards.
(d) Subgrantees.--A quality improvement organization with which the
Secretary has entered into a contract under part B of title XI of the
Social Security Act (42 U.S.C. 1320c et seq.) may serve as the
subgrantee under this subsection to develop peer review processes as
described in subsection (a).
SEC. 104. PRESCRIPTION DRUG AND OTHER CONTROLLED SUBSTANCE ABUSE
PREVENTION.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399V-6. PRESCRIPTION DRUG AND OTHER CONTROLLED SUBSTANCE ABUSE
PREVENTION.
``(a) Training Grants.--
``(1) In general.--The Secretary shall award 5-year grants
to eligible entities to facilitate training in order to
increase the capacity of health care providers to conduct
patient screening and brief interventions, such as in health
care settings, to prevent the abuse of prescription drugs and
other controlled substances. The grant program under this
section may be coordinated with the Screening Brief
Intervention and Referral to Treatment grant program of the
Substance Abuse and Mental Health Services Administration, or
other appropriate program.
``(2) Eligible entities.--In this subsection, the term
`eligible entity' includes--
``(A) States;
``(B) continuing education entities, such as health
profession boards or health accrediting bodies; and
``(C) other appropriate health or professional
education organizations or institutions.
``(b) Federal Health Care Workers.--Health care providers who
participate in or are employed by a Federal health care program,
including the Indian Health Service, the Department of Veterans
Affairs, the Department of Defense, the Federal Bureau of Prisons, the
Medicare program under title XVIII of the Social Security Act (42
U.S.C. 1395 et seq.), a State Medicaid plan under title XIX of the
Social Security Act (42 U.S.C. 1396 et seq.), the State Children's
Health Insurance Program under title XXI of the Social Security Act (42
U.S.C. 1397aa et seq.), and Federally qualified health centers, shall
screen patients for abuse of prescription drugs or other controlled
substances, conduct brief interventions, and provide referrals for
known or suspected abuse of prescription drugs or other controlled
substances, as appropriate.
``(c) Expansion of Prescribing Authority.--The Secretary, acting
through the Administrator of the Health Resources and Services
Administration, shall award grants to States for the purpose of
evaluating the prospect of the health professions board of such States
reviewing and expanding prescribing authorities of providers, such as
advance practice nurses and physician assistants, in order to control
the abuse of prescription drugs or other controlled substances with
respect to specific drugs and other controlled substances, as
appropriate.''.
SEC. 105. PRESCRIPTION DRUG ABUSE TRAINING AND SCREENING PROGRAMS.
(a) Continuing Education Grants.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'') shall award
grants to States to develop continuing education criteria and review
processes that allow State health profession boards or State agencies
to certify appropriate education and training for informed and safe
prescribing of opioids and other drugs on schedule II and III under
section 202 of the Controlled Substances Act (21 U.S.C. 812).
(b) Registration With DEA.--A practitioner who registers or renews
a registration under section 303(f) of the Controlled Substances Act
(21 U.S.C. 823(f)) shall, at the time of registering, certify to the
Attorney General that such practitioner has completed continuing
medical education or nursing continuing education, as applicable--
(1) in the case of a practitioner registering for the first
time, with respect to prescription drug abuse; and
(2) in the case of a practitioner renewing a registration,
with respect to medical understanding of the proper use of all
drugs listed in the schedules under section 202 of the
Controlled Substances Act (21 U.S.C. 812).
(c) Screening Program.--The Attorney General shall require that a
practitioner registered under section 303(f) of the Controlled
Substances Act (21 U.S.C. 823(f)) conduct patient screening for
potential drug misuse or abuse before prescribing a drug listed on
schedule II or III under section 202 of the Controlled Substances Act
(21 U.S.C. 812), according to standards established by the applicable
State licensing body.
SEC. 106. FDA REVIEW OF NALOXONE.
The Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall conduct a review of naloxone to
consider whether naloxone should cease to be subject to section
503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353(b)(1)) and be available as a behind-the-counter drug, in order to
increase access of such drug to community-based organizations and
street outreach organizations.
SEC. 107. PRESCRIPTION DRUG DISPOSAL.
The Secretary of Health and Human Services shall convene or
coordinate with an existing entity an interagency working group to
encourage States and local governments to increase opportunities for
disposal of opiates, such as frequent ``take-back programs'' and fixed
medicine disposal sites at law enforcement public buildings, and to
reduce opportunities for abuse of opiates, such as establishing opioid
dispensing limits at hospital emergency departments.
SEC. 108. GAO REPORT.
The Comptroller General of the United States shall review
prescription drug abuse programs and policies in Federal agencies and
best practices with respect to prescription drug abuse programs of the
States and, not later than 18 months after the date of enactment of
this Act, shall issue a report to Congress on its findings and
recommendations on ways to reduce prescription drug abuse.
TITLE II--TREAT ACT
SEC. 201. SHORT TITLE.
This title may be cited as the ``Recovery Enhancement for Addiction
Treatment Act'' or the ``TREAT Act''.
SEC. 202. 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. 203. 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, seminar
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,
seminar 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.
``(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. 204. 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 Agency inspections of
waived practitioners, including the frequency with which the
Drug Enforcement Agency 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 Agency for expanding effective opioid addiction
treatment.
<all>