Co-Prescribing Saves Lives Act of 2016
This bill requires the Department of Health and Human Services (HHS), the Department of Veterans Affairs (VA), and the Department of Defense (DOD) to: (1) establish training guidelines for federal health care facilities and federally qualified health centers; and (2) train certain health care providers at federal health care facilities on best practices for prescribing pain medications, principles of pain management, the misuse potential of controlled substances, identification of potential substance use disorders and referral to further evaluation and treatment, and disposal of controlled substances.
HHS, the VA, and DOD must establish, for certain health care facilities, guidelines for the prescription of naloxone to individuals at an elevated risk of overdose. (Naloxone is a prescription drug used to rapidly reverse an overdose of opioids, which are drugs with effects similar to opium, such as heroin and certain pain medications.)
HHS must award grants to state departments of health for the development and application of guidelines for the prescription of opioid overdose reversal drugs and to increase access to naloxone. Grants may be used to:
[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4841 Introduced in House (IH)]
<DOC>
114th CONGRESS
2d Session
H. R. 4841
To establish programs for health care provider training in Federal
health care and medical facilities, to establish Federal co-prescribing
guidelines, to establish a grant program with respect to naloxone, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 23, 2016
Mr. Rothfus (for himself and Mr. Keating) introduced the following
bill; which was referred to the Committee on Energy and Commerce, and
in addition to the Committees on Armed Services, Veterans' Affairs, and
Natural Resources, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To establish programs for health care provider training in Federal
health care and medical facilities, to establish Federal co-prescribing
guidelines, to establish a grant program with respect to naloxone, 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 ``Co-Prescribing Saves Lives Act of
2016''.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) Together, the misuse of heroin and opioids account for
approximately 25,000 deaths in the United States per year.
(2) Drug overdose was the leading cause of injury death in
the United States in 2013, and among people 25 to 64 years old,
drug overdose caused more deaths than motor vehicle fatalities
in 2013.
(3) According to the Centers for Disease Control and
Prevention, in the United States, fatal opioid-related drug
overdose rates have more than quadrupled since 1990 and have
never been higher. Each day in the United States, 46 people die
from an overdose of prescription painkillers. Nearly 2,000,000
Americans aged 12 or older either abused or were dependent on
opioids in 2013.
(4) Naloxone is a safe and effective antidote to all
opioid-related overdoses, including heroin and fentanyl, and is
a critical tool in preventing fatal opioid overdoses in both
health care and at-home settings.
(5) The opioid overdose antidote naloxone has reversed more
than 26,000 overdose cases between 1996 and 2014, according to
the Centers for Disease Control and Prevention.
SEC. 3. HEALTH CARE PROVIDER TRAINING IN FEDERAL HEALTH CARE AND
MEDICAL FACILITIES.
(a) Guidelines.--
(1) HHS guidelines.--The Secretary of Health and Human
Services shall establish health care provider training
guidelines for all Federal health care facilities, including
Federally qualified health centers (as defined in paragraph (4)
of section 1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa))) and facilities of the Indian Health Service, and
shall provide training to all providers described in subsection
(b), in accordance with subsection (c).
(2) Department of veterans affairs guidelines.--The
Secretary of Veterans Affairs shall establish health care
provider training guidelines for all medical facilities of the
Department of Veterans Affairs, and shall provide training to
all providers described in subsection (b), in accordance with
subsection (c).
(3) Department of defense guidelines.--The Secretary of
Defense shall establish health care provider training
guidelines for all medical facilities of the Department of
Defense, and shall provide training to all providers described
in subsection (b), in accordance with subsection (c).
(b) Affected Health Care Providers.--The guidelines developed under
paragraphs (1) through (3) of subsection (a) shall ensure that training
on the appropriate and effective prescribing of opioid medications is
provided to all health care providers who are--
(1) Federal employees and who prescribe controlled
substances as part of their official responsibilities and
duties as Federal employees;
(2) contractors in a health care or medical facility of an
agency described in paragraph (1), (2), or (3) of subsection
(a) who--
(A) spend 50 percent or more of their clinical time
under contract with the Federal Government; and
(B) prescribe controlled substances under the terms
and conditions of their contract or agreement with the
Federal Government; or
(3) clinical residents and other clinical trainees who
spend 50 percent or more of their clinical time practicing in a
health care or medical facility of an agency described in
paragraph (1), (2), or (3) of subsection (a).
(c) Training Requirements.--
(1) Training topics.--The training developed under
paragraphs (1) through (3) of subsection (a) shall address, at
a minimum, best practices for appropriate and effective
prescribing of pain medications, principles of pain management,
the misuse potential of controlled substances, identification
of potential substance use disorders and referral to further
evaluation and treatment, and proper methods for disposing of
controlled substances.
(2) Training approaches.--The training approaches developed
in accordance with this section may include both traditional
continuing education models and models that pair intensive
coaching for the highest volume prescribers with case-based
courses for other prescribers.
(3) Consistency with consensus guidelines.--To the extent
practicable, training adopted under subsection (a) shall be
consistent with consensus guidelines on pain medication
prescribing developed by the Centers for Disease Control and
Prevention.
(4) Training frequency.--Each agency described in
paragraphs (1) through (3) of subsection (a) shall provide
training of the health care providers in accordance with this
section not later than 18 months after the date of enactment of
this Act, and every 3 years thereafter.
(d) Definitions.--For purposes of this section, the term
``controlled substance'' has the meaning given such term in section 102
of the Controlled Substances Act (21 U.S.C. 802).
SEC. 4. NALOXONE CO-PRESCRIBING IN FEDERAL HEALTH CARE AND MEDICAL
FACILITIES.
(a) Naloxone Co-Prescribing Guidelines.--Not later than 180 days
after the date of enactment of this Act:
(1) The Secretary of Health and Human Services shall
establish naloxone co-prescribing guidelines applicable to all
Federally qualified health centers (as defined in paragraph (4)
of section 1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa))) and the health care facilities of the Indian Health
Service.
(2) The Secretary of Defense shall establish co-prescribing
guidelines applicable to all Department of Defense medical
facilities.
(3) The Secretary of Veterans Affairs shall establish co-
prescribing guidelines applicable to all Department of Veterans
Affairs medical facilities.
(b) Requirement.--The guidelines established under subsection (a)
shall address naloxone co-prescribing for both pain patients receiving
chronic opioid therapy and patients being treated for opioid use
disorders.
(c) Definitions.--In this section:
(1) Co-prescribing.--The term ``co-prescribing'' means,
with respect to an opioid overdose reversal drug, the practice
of prescribing such drug in conjunction with an opioid
prescription for patients at an elevated risk of overdose, or
in conjunction with an opioid agonist approved under section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
for the treatment of opioid use disorders, or in other
circumstances in which a provider identifies a patient at an
elevated risk for an intentional or unintentional drug overdose
from heroin or prescription opioid therapies.
(2) Elevated risk of overdose.--The term ``elevated risk of
overdose'' has the meaning given such term by the Secretary of
Health and Human Services, which--
(A) may be based on the criteria provided in the
Opioid Overdose Toolkit published by the Substance
Abuse and Mental Health Services Administration; and
(B) may include patients on a first course opioid
treatment, patients using extended-release and long-
acting opioid analgesic, and patients with a
respiratory disease or other co-morbidities.
SEC. 5. GRANT PROGRAM TO STATE DEPARTMENTS OF HEALTH TO EXPAND NALOXONE
CO-PRESCRIBING.
(a) Establishment.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall establish a
competitive 4-year co-prescribing opioid overdose reversal drugs grant
program to provide State departments of health with resources to
develop and apply co-prescribing guidelines, and to provide for
increased access to naloxone.
(b) Application.--To be eligible to receive a grant under this
section, a State shall submit to the Secretary, in such form and manner
as the Secretary may require, an application that--
(1) identifies community partners for a co-prescribing
program;
(2) identifies which providers will be trained in such
program and the criteria that will be used to identify eligible
patients to participate in such program; and
(3) describes how the program will seek to identify State,
local, or private funding to continue the program after
expiration of the grant.
(c) Prioritization.--In awarding grants under this section, the
Secretary shall give priority to eligible State departments of health
that propose to base State guidelines on guidelines on co-prescribing
already in existence at the time of application, such as guidelines of
the Department of Veterans Affairs or national medical societies, such
as the American Society of Addiction Medicine or American Medical
Association.
(d) Use of Funds.--A State department of health receiving a grant
under this section may use the grant for any of the following
activities:
(1) To establish a program for co-prescribing opioid
overdose reversal drugs, such as naloxone.
(2) To expand innovative models of naloxone distribution,
as defined by the Secretary.
(3) To train and provide resources for health care
providers and pharmacists on the co-prescribing of opioid
overdose reversal drugs.
(4) To establish mechanisms and processes for tracking
patients participating in the program described in paragraph
(1) and the health outcomes of such patients, and ensuring that
health information is de-identified so as to protect patient
privacy.
(5) To purchase opioid overdose reversal drugs for
distribution under the program described in paragraph (1).
(6) To offset the copayments and other cost-sharing
associated with opioid overdose reversal drugs to ensure that
cost is not a limiting factor for eligible individuals, as
determined by the Secretary and the applicable State department
of health, giving priority to individuals not otherwise insured
for such services.
(7) To conduct community outreach, in conjunction with
community-based organizations, designed to raise awareness of
co-prescribing practices, and the availability of opioid
overdose reversal drugs.
(8) To establish protocols to connect patients who have
experienced a drug overdose with appropriate treatment,
including appropriate counseling and behavioral therapies. Such
protocols shall be consistent with nationally recognized
patient placement criteria, such as the criteria of the
American Society of Addiction Medicine.
(e) Evaluations by Recipients.--As a condition of receipt of a
grant under this section, a State department of health shall, for each
year for which grant funds are received, submit to the Secretary
information on appropriate outcome measures specified by the Secretary
to assess the outcomes of the program funded by the grant.
(f) Definition.--In this section, the term ``co-prescribing'' has
the meaning given such term in section 4.
SEC. 6. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to carry out this Act
$2,500,000 for each of fiscal years 2017 through 2021.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services, Veterans' Affairs, and Natural Resources, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services, Veterans' Affairs, and Natural Resources, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services, Veterans' Affairs, and Natural Resources, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services, Veterans' Affairs, and Natural Resources, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services, Veterans' Affairs, and Natural Resources, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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Referred to the Subcommittee on Health.
Referred to the Subcommittee on Indian, Insular and Alaska Native Affairs.
Referred to the Subcommittee on Military Personnel.