[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4063 Referred in Senate (RFS)]
<DOC>
114th CONGRESS
2d Session
H. R. 4063
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 11, 2016
Received; read twice and referred to the Committee on Veterans' Affairs
_______________________________________________________________________
AN ACT
To improve the use by the Secretary of Veterans Affairs of opioids in
treating veterans, and for other purposes.
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 ``Promoting Responsible Opioid
Management and Incorporating Scientific Expertise Act'' or the ``Jason
Simcakoski PROMISE Act''.
SEC. 2. IMPROVEMENT OF OPIOID SAFETY MEASURES BY DEPARTMENT OF VETERANS
AFFAIRS.
(a) Expansion of Opioid Safety Initiative.--
(1) Inclusion of all medical facilities.--Not later than
180 days after the date of the enactment of this Act, the
Secretary of Veterans Affairs shall expand the Opioid Safety
Initiative of the Department of Veterans Affairs to include all
medical facilities of the Department.
(2) Guidance.--The Secretary shall establish guidance that
each health care provider of the Department of Veterans
Affairs, before initiating opioid therapy to treat a patient as
part of the comprehensive assessment conducted by the health
care provider, use the Opioid Therapy Risk Report tool of the
Department of Veterans Affairs (or any subsequent tool), which
shall include information from the prescription drug monitoring
program of each participating State as applicable, that
includes the most recent information to date relating to the
patient that accessed such program to assess the risk for
adverse outcomes of opioid therapy for the patient, including
the concurrent use of controlled substances such as
benzodiazepines, as part of the comprehensive assessment
conducted by the health care provider.
(3) Enhanced standards.--The Secretary shall establish
enhanced standards with respect to the use of routine and
random urine drug tests for all patients before and during
opioid therapy to help prevent substance abuse, dependence, and
diversion, including--
(A) that such tests occur not less frequently than
once each year; and
(B) that health care providers appropriately order,
interpret and respond to the results from such tests to
tailor pain therapy, safeguards, and risk management
strategies to each patient.
(b) Pain Management Education and Training.--
(1) In general.--In carrying out the Opioid Safety
Initiative of the Department, the Secretary shall require all
employees of the Department responsible for prescribing opioids
to receive education and training described in paragraph (2).
(2) Education and training.--Education and training
described in this paragraph is education and training on pain
management and safe opioid prescribing practices for purposes
of safely and effectively managing patients with chronic pain,
including education and training on the following:
(A) The implementation of and full compliance with
the VA/DOD Clinical Practice Guideline for Management
of Opioid Therapy for Chronic Pain, including any
update to such guideline.
(B) The use of evidence-based pain management
therapies, including cognitive-behavioral therapy, non-
opioid alternatives, and non-drug methods and
procedures to managing pain and related health
conditions including medical devices approved or
cleared by the Food and Drug Administration for the
treatment of patients with chronic pain and
complementary alternative medicines.
(C) Screening and identification of patients with
substance use disorder, including drug-seeking
behavior, before prescribing opioids, assessment of
risk potential for patients developing an addiction,
and referral of patients to appropriate addiction
treatment professionals if addiction is identified or
strongly suspected.
(D) Communication with patients on the potential
harm associated with the use of opioids and other
controlled substances, including the need to safely
store and dispose of supplies relating to the use of
opioids and other controlled substances.
(E) Such other education and training as the
Secretary considers appropriate to ensure that veterans
receive safe and high-quality pain management care from
the Department.
(3) Use of existing program.--In providing education and
training described in paragraph (2), the Secretary shall use
the Interdisciplinary Chronic Pain Management Training Team
Program of the Department (or success program).
(c) Pain Management Teams.--
(1) In general.--In carrying out the Opioid Safety
Initiative of the Department, the director of each medical
facility of the Department shall identify and designate a pain
management team of health care professionals, which may include
board certified pain medicine specialists, responsible for
coordinating and overseeing pain management therapy at such
facility for patients experiencing acute and chronic pain that
is non-cancer related.
(2) Establishment of protocols.--
(A) In general.--In consultation with the Directors
of each Veterans Integrated Service Network, the
Secretary shall establish standard protocols for the
designation of pain management teams at each medical
facility within the Department.
(B) Consultation on prescription of opioids.--Each
protocol established under subparagraph (A) shall
ensure that any health care provider without expertise
in prescribing analgesics or who has not completed the
education and training under subsection (b), including
a mental health care provider, does not prescribe
opioids to a patient unless that health care provider--
(i) consults with a health care provider
with pain management expertise or who is on the
pain management team of the medical facility;
and
(ii) refers the patient to the pain
management team for any subsequent
prescriptions and related therapy.
(3) Report.--
(A) In general.--Not later than 1 year after the
date of enactment of this Act, the director of each
medical facility of the Department shall submit to the
Under Secretary for Health and the director of the
Veterans Integrated Service Network in which the
medical facility is located a report identifying the
health care professionals that have been designated as
members of the pain management team at the medical
facility pursuant to paragraph (1).
(B) Elements.--Each report submitted under
subparagraph (A) with respect to a medical facility of
the Department shall include--
(i) a certification as to whether all
members of the pain management team at the
medical facility have completed the education
and training required under subsection (b);
(ii) a plan for the management and referral
of patients to such pain management team if
health care providers without expertise in
prescribing analgesics prescribe opioid
medications to treat acute and chronic pain
that is non-cancer related; and
(iii) a certification as to whether the
medical facility--
(I) fully complies with the
stepped-care model of pain management
and other pain management policies
contained in Directive 2009-053 of the
Veterans Health Administration, or
successor directive; or
(II) does not fully comply with
such stepped-care model of pain
management and other pain management
policies but is carrying out a
corrective plan of action to ensure
such full compliance.
(d) Tracking and Monitoring of Opioid Use.--
(1) Prescription drug monitoring programs of states.--In
carrying out the Opioid Safety Initiative and the Opioid
Therapy Risk Report tool of the Department, the Secretary
shall--
(A) ensure access by health care providers of the
Department to information on controlled substances,
including opioids and benzodiazepines, prescribed to
veterans who receive care outside the Department
through the prescription drug monitoring program of
each State with such a program, including by seeking to
enter into memoranda of understanding with States to
allow shared access of such information between States
and the Department;
(B) include such information in the Opioid Therapy
Risk Report; and
(C) require health care providers of the Department
to submit to the prescription drug monitoring program
of each State information on prescriptions of
controlled substances received by veterans in that
State under the laws administered by the Secretary.
(2) Report on tracking of data on opioid use.--Not later
than 18 months after the date of the enactment of this Act, the
Secretary shall submit to the Committee on Veterans' Affairs of
the Senate and the Committee on Veterans' Affairs of the House
of Representatives a report on the feasibility and advisability
of improving the Opioid Therapy Risk Report tool of the
Department to allow for more advanced real-time tracking of and
access to data on--
(A) the key clinical indicators with respect to the
totality of opioid use by veterans;
(B) concurrent prescribing by health care providers
of the Department of opioids in different health care
settings, including data on concurrent prescribing of
opioids to treat mental health disorders other than
opioid use disorder; and
(C) mail-order prescriptions of opioid prescribed
to veterans under the laws administered by the
Secretary.
(e) Availability of Opioid Receptor Antagonists.--
(1) Increased availability and use.--
(A) In general.--The Secretary shall maximize the
availability of opioid receptor antagonists approved by
the Food and Drug Administration, including naloxone,
to veterans.
(B) Availability, training, and distributing.--In
carrying out subparagraph (A), not later than 90 days
after the date of the enactment of this Act, the
Secretary shall--
(i) equip each pharmacy of the Department
with opioid receptor antagonists approved by
the Food and Drug Administration to be
dispensed to outpatients as needed; and
(ii) expand the Overdose Education and
Naloxone Distribution program of the Department
to ensure that all veterans in receipt of
health care under laws administered by the
Secretary who are at risk of opioid overdose
may access such opioid receptor antagonists and
training on the proper administration of such
opioid receptor antagonists.
(C) Veterans who are at risk.--For purposes of
subparagraph (B), veterans who are at risk of opioid
overdose include--
(i) veterans receiving long-term opioid
therapy;
(ii) veterans receiving opioid therapy who
have a history of substance use disorder or
prior instances of overdose; and
(iii) veterans who are at risk as
determined by a health care provider who is
treating the veteran.
(2) Report.--Not later than 120 days after the date of the
enactment of this Act, the Secretary shall submit to the
Committee on Veterans' Affairs of the Senate and the Committee
on Veterans' Affairs of the House of Representatives a report
on carrying out paragraph (1), including an assessment of any
remaining steps to be carried out by the Secretary to carry out
such paragraph.
(f) Inclusion of Certain Information and Capabilities in Opioid
Therapy Risk Report Tool of the Department.--
(1) Information.--The Secretary shall include in the Opioid
Therapy Risk Report tool of the Department--
(A) information on the most recent time the tool
was accessed by a health care provider of the
Department with respect to each veteran; and
(B) information on the results of the most recent
urine drug test for each veteran.
(2) Capabilities.--The Secretary shall include in the
Opioid Therapy Risk Report tool the ability of the health care
providers of the Department to determine whether a health care
provider of the Department prescribed opioids to a veteran
without checking the information in the tool with respect to
the veteran.
(g) Notifications of Risk in Computerized Health Record.--The
Secretary shall modify the computerized patient record system of the
Department to ensure that any health care provider that accesses the
record of a veteran, regardless of the reason the veteran seeks care
from the health care provider, will be immediately notified whether the
veteran--
(1) is receiving opioid therapy and has a history of
substance use disorder or prior instances of overdose;
(2) has a history of opioid abuse; or
(3) is at risk of becoming an opioid abuser as determined
by a health care provider who is treating the veteran.
(h) Definitions.--In this section:
(1) The term ``controlled substance'' has the meaning given
that term in section 102 of the Controlled Substances Act (21
U.S.C. 802).
(2) The term ``State'' means each of the several States,
territories, and possessions of the United States, the District
of Columbia, and the Commonwealth of Puerto Rico.
SEC. 3. STRENGTHENING OF JOINT WORKING GROUP ON PAIN MANAGEMENT OF THE
DEPARTMENT OF VETERANS AFFAIRS AND THE DEPARTMENT OF
DEFENSE.
(a) In General.--Not later than 90 days after the date of enactment
of this Act, the Secretary of Veterans Affairs and the Secretary of
Defense shall ensure that the Pain Management Working Group of the
Health Executive Committee of the Department of Veterans Affairs-
Department of Defense Joint Executive Committee (Pain Management
Working Group) established under section 320 of title 38, United States
Code, includes a focus on the following:
(1) The opioid prescribing practices of health care
providers of each Department.
(2) The ability of each Department to manage acute and
chronic pain among individuals receiving health care from the
Department, including training health care providers with
respect to pain management.
(3) The use by each Department of complementary and
integrative health and complementary alternative medicines in
treating such individuals.
(4) The concurrent use by health care providers of each
Department of opioids and prescription drugs to treat mental
health disorders, including benzodiazepines.
(5) The practice by health care providers of each
Department of prescribing opioids to treat mental health
disorders.
(6) The coordination in coverage of and consistent access
to medications prescribed for patients transitioning from
receiving health care from the Department of Defense to
receiving health care from the Department of Veterans Affairs.
(7) The ability of each Department to identify and treat
substance use disorders among individuals receiving health care
from that Department.
(b) Coordination and Consultation.--The Secretary of Veterans
Affairs and the Secretary of Defense shall ensure that the working
group described in subsection (a)--
(1) coordinates the activities of the working group with
other relevant working groups established under section 320 of
title 38, United States Code;
(2) consults with other relevant Federal agencies with
respect to the activities of the working group; and
(3) consults with the Department of Veterans Affairs and
the Department of Defense with respect to, reviews, and
comments on the VA/DOD Clinical Practice Guideline for
Management of Opioid Therapy for Chronic Pain, or any successor
guideline, before any update to the guideline is released.
(c) Clinical Practice Guidelines.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, the Secretary of Veterans Affairs
and the Secretary of Defense shall issue an update to the VA/
DOD Clinical Practice Guideline for Management of Opioid
Therapy for Chronic Pain.
(2) Matters included.--In conducting the update under
subsection (a), the Pain Management Working Group, in
coordination with the Clinical Practice Guideline VA/DOD
Management of Opioid Therapy for Chronic Pain Working Group,
shall examine whether the Clinical Practical Guideline should
include the following:
(A) Enhanced guidance with respect to--
(i) the coadministration of an opioid and
other drugs, including benzodiazepines, that
may result in life-limiting drug interactions;
(ii) the treatment of patients with current
acute psychiatric instability or substance use
disorder or patients at risk of suicide; and
(iii) the use of opioid therapy to treat
mental health disorders other than opioid use
disorder.
(B) Enhanced guidance with respect to the treatment
of patients with behaviors or comorbidities, such as
post-traumatic stress disorder or other psychiatric
disorders, or a history of substance abuse or
addiction, that requires a consultation or comanagement
of opioid therapy with one or more specialists in pain
management, mental health, or addictions.
(C) Enhanced guidance with respect to health care
providers--
(i) conducting an effective assessment for
patients beginning or continuing opioid
therapy, including understanding and setting
realistic goals with respect to achieving and
maintaining an expected level of pain relief,
improved function, or a clinically appropriate
combination of both; and
(ii) effectively assessing whether opioid
therapy is achieving or maintaining the
established treatment goals of the patient or
whether the patient and health care provider
should discuss adjusting, augmenting, or
discontinuing the opioid therapy.
(D) Guidelines to govern the methodologies used by
health care providers of the Department of Veterans
Affairs and the Department of Defense to taper opioid
therapy when adjusting or discontinuing the use of
opioid therapy.
(E) Guidelines with respect to appropriate case
management for patients receiving opioid therapy who
transition between inpatient and outpatient health care
settings, which may include the use of care transition
plans.
(F) Guidelines with respect to appropriate case
management for patients receiving opioid therapy who
transition from receiving care during active duty to
post-military health care networks.
(G) Guidelines with respect to providing options,
before initiating opioid therapy, for pain management
therapies without the use of opioids and options to
augment opioid therapy with other clinical and
complementary and integrative health services to
minimize opioid dependence.
(H) Guidelines with respect to the provision of
evidence-based non-opioid treatments within the
Department of Veterans Affairs and the Department of
Defense, including medical devices and other therapies
approved or cleared by the Food and Drug Administration
for the treatment of chronic pain as an alternative to
or to augment opioid therapy.
SEC. 4. REVIEW, INVESTIGATION, AND REPORT ON USE OF OPIOIDS IN
TREATMENT BY DEPARTMENT OF VETERANS AFFAIRS.
(a) Comptroller General Report.--
(1) In general.--Not later than 2 years after the date of
the enactment of this Act, the Comptroller General of the
United States shall submit to the Committee on Veterans'
Affairs of the Senate and the Committee on Veterans' Affairs of
the House of Representatives a report on the Opioid Safety
Initiative of the Department of Veterans Affairs and the opioid
prescribing practices of health care providers of the
Department.
(2) Elements.--The report submitted under paragraph (1)
shall include the following:
(A) Recommendations on such improvements to the
Opioid Safety Initiative of the Department as the
Comptroller General considers appropriate.
(B) Information with respect to--
(i) deaths resulting from sentinel events
involving veterans prescribed opioids by a
health care provider of the Department;
(ii) overall prescription rates and
prescriptions indications of opioids to treat
non-cancer, non-palliative, and non-hospice
care patients;
(iii) the prescription rates and
prescriptions indications of benzodiazepines
and opioids concomitantly by health care
providers of the Department;
(iv) the practice by health care providers
of the Department of prescribing opioids to
treat patients without any pain, including to
treat patients with mental health disorders
other than opioid use disorder; and
(v) the effectiveness of opioid therapy for
patients receiving such therapy, including the
effectiveness of long-term opioid therapy.
(C) An evaluation of processes of the Department in
place to oversee opioid use among veterans, including
procedures to identify and remedy potential over-
prescribing of opioids by health care providers of the
Department.
(D) An assessment of the implementation by the
Secretary of the VA/DOD Clinical Practice Guideline for
Management of Opioid Therapy for Chronic Pain.
(b) Quarterly Progress Report on Implementation of Comptroller
General Recommendations.--Not later than 2 years after the date of the
enactment of this Act, and not later than 30 days after the end of each
quarter thereafter, the Secretary of Veterans Affairs shall submit to
the Committee on Veterans' Affairs of the Senate and the Committee on
Veterans' Affairs of the House of Representatives a progress report
detailing the actions by the Secretary during the period covered by the
report to address any outstanding findings and recommendations by the
Comptroller General of the United States under subsection (a) with
respect to the Veterans Health Administration.
(c) Annual Review of Prescription Rates.--Not later than 1 year
after the date of the enactment of this Act, and not less frequently
than annually for the following 5 years, the Secretary shall submit to
the Committee on Veterans' Affairs of the Senate and the Committee on
Veterans' Affairs of the House of Representatives a report, with
respect to each medical facility of the Department of Veterans Affairs,
to collect and review information on opioids prescribed by health care
providers at the facility to treat non-cancer, non-palliative, and non-
hospice care patients that contains, for the 1-year period preceding
the submission of the report, the following:
(1) The number of patients and the percentage of the
patient population of the Department who were prescribed
benzodiazepines and opioids concurrently by a health care
provider of the Department.
(2) The number of patients and the percentage of the
patient population of the Department without any pain who were
prescribed opioids by a health care provider of the Department,
including those who were prescribed benzodiazepines and opioids
concurrently.
(3) The number of non-cancer, non-palliative, and non-
hospice care patients and the percentage of such patients who
were treated with opioids by a health care provider of the
Department on an inpatient-basis and who also received
prescription opioids by mail from the Department while being
treated on an inpatient-basis.
(4) The number of non-cancer, non-palliative, and non-
hospice care patients and the percentage of such patients who
were prescribed opioids concurrently by a health care provider
of the Department and a health care provider that is not health
care provider of the Department.
(5) With respect to each medical facility of the
Department, information on opioids prescribed by health care
providers at the facility to treat non-cancer, non-palliative,
and non-hospice care patients, including information on--
(A) the prescription rate at which each health care
provider at the facility prescribed benzodiazepines and
opioids concurrently to such patients and the aggregate
such prescription rate for all health care providers at
the facility;
(B) the prescription rate at which each health care
provider at the facility prescribed benzodiazepines or
opioids to such patients to treat conditions for which
benzodiazepines or opioids are not approved treatment
and the aggregate such prescription rate for all health
care providers at the facility;
(C) the prescription rate at which each health care
provider at the facility prescribed or dispensed mail-
order prescriptions of opioids to such patients while
such patients were being treated with opioids on an
inpatient-basis and the aggregate of such prescription
rate for all health care providers at the facility; and
(D) the prescription rate at which each health care
provider at the facility prescribed opioids to such
patients who were also concurrently prescribed opioids
by a health care provider that is not a health care
provider of the Department and the aggregate of such
prescription rates for all health care providers at the
facility.
(6) With respect to each medical facility of the
Department, the number of times a pharmacist at the facility
overrode a critical drug interaction warning with respect to an
interaction between opioids and another medication before
dispensing such medication to a veteran.
(d) Investigation of Prescription Rates.--If the Secretary
determines that a prescription rate with respect to a health care
provider or medical facility of the Department conflicts with or is
otherwise inconsistent with the standards of appropriate and safe care,
the Secretary shall--
(1) immediately notify the Committee on Veterans' Affairs
of the Senate and the Committee on Veterans' Affairs of the
House of Representatives of such determination, including
information relating to such determination, prescription rate,
and health care provider or medical facility, as the case may
be; and
(2) through the Office of the Medical Inspector of the
Veterans Health Administration, conduct a full investigation of
the health care provider or medical facility, as the case may
be.
(e) Prescription Rate Defined.--In this section, the term
``prescription rate'' means, with respect to a health care provider or
medical facility of the Department, each of the following:
(1) The number of patients treated with opioids by the
health care provider or at the medical facility, as the case
may be, divided by the total number of pharmacy users of that
health care provider or medical facility.
(2) The average number of morphine equivalents per day
prescribed by the health care provider or at the medical
facility, as the case may be, to patients being treated with
opioids.
(3) Of the patients being treated with opioids by the
health care provider or at the medical facility, as the case
may be, the average number of prescriptions of opioids per
patient.
SEC. 5. MANDATORY DISCLOSURE OF CERTAIN VETERAN INFORMATION TO STATE
CONTROLLED SUBSTANCE MONITORING PROGRAMS.
Section 5701(l) of title 38, United States Code, is amended by
striking ``may'' and inserting ``shall''.
SEC. 6. MODIFICATION TO LIMITATION ON AWARDS AND BONUSES.
Section 705 of the Veterans Access, Choice, and Accountability Act
of 2014 (Public Law 113-146; 38 U.S.C. 703 note) is amended to read as
follows:
``SEC. 705. LIMITATION ON AWARDS AND BONUSES PAID TO EMPLOYEES OF
DEPARTMENT OF VETERANS AFFAIRS.
``The Secretary of Veterans Affairs shall ensure that the aggregate
amount of awards and bonuses paid by the Secretary in a fiscal year
under chapter 45 or 53 of title 5, United States Code, or any other
awards or bonuses authorized under such title or title 38, United
States Code, does not exceed the following amounts:
``(1) With respect to each of fiscal years 2017 through
2021, $230,000,000.
``(2) With respect to each of fiscal years 2022 through
2024, $360,000,000.''.
Passed the House of Representatives May 10, 2016.
Attest:
KAREN L. HAAS,
Clerk.