[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2256 Reported in Senate (RS)]
<DOC>
Calendar No. 442
114th CONGRESS
2d Session
S. 2256
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 SENATE OF THE UNITED STATES
November 5, 2015
Mr. Kaine (for himself and Mrs. Capito) 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 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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Co-Prescribing Saves Lives
Act of 2015''.</DELETED>
<DELETED>SEC. 2. FINDINGS.</DELETED>
<DELETED> Congress finds as follows:</DELETED>
<DELETED> (1) Together, the misuse of heroin and opioids
account for approximately 25,000 deaths in the United States
per year.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 3. HEALTH CARE PROVIDER TRAINING IN FEDERAL HEALTH CARE
AND MEDICAL FACILITIES.</DELETED>
<DELETED> (a) Guidelines.--</DELETED>
<DELETED> (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).</DELETED>
<DELETED> (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).</DELETED>
<DELETED> (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).</DELETED>
<DELETED> (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--
</DELETED>
<DELETED> (1) Federal employees and who prescribe controlled
substances as part of their official responsibilities and
duties as Federal employees;</DELETED>
<DELETED> (2) contractors in a health care or medical
facility of an agency described in paragraph (1), (2), or (3)
of subsection (a) who--</DELETED>
<DELETED> (A) spend 50 percent or more of their
clinical time under contract with the Federal
Government; and</DELETED>
<DELETED> (B) prescribe controlled substances under
the terms and conditions of their contract or agreement
with the Federal Government; or</DELETED>
<DELETED> (3) clinical residents and other clinical trainees
who spend 50 percent or more of their clinical time practicing
in health care or medical facility of an agency described in
paragraph (1), (2), or (3) of subsection (a).</DELETED>
<DELETED> (c) Training Requirements.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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).</DELETED>
<DELETED>SEC. 4. NALOXONE CO-PRESCRIBING IN FEDERAL HEALTH CARE AND
MEDICAL FACILITIES.</DELETED>
<DELETED> (a) Naloxone Co-Prescribing Guidelines.--Not later than
180 days after the date of enactment of this Act:</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (2) The Secretary of Defense shall establish co-
prescribing guidelines applicable to all Department of Defense
medical facilities.</DELETED>
<DELETED> (3) The Secretary of Veterans Affairs shall
establish co-prescribing guidelines applicable to all
Department of Veterans Affairs medical facilities.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (c) Definitions.--In this section:</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--
</DELETED>
<DELETED> (A) may be based on the criteria provided
in the Opioid Overdose Toolkit published by the
Substance Abuse and Mental Health Services
Administration; and</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 5. GRANT PROGRAM TO STATE DEPARTMENTS OF HEALTH TO EXPAND
NALOXONE CO-PRESCRIBING.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (1) identifies community partners for a co-
prescribing program;</DELETED>
<DELETED> (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</DELETED>
<DELETED> (3) describes how the program will seek to
identify State, local, or private funding to continue the
program after expiration of the grant.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> (1) To establish a program for co-prescribing
opioid overdose reversal drugs, such as naloxone.</DELETED>
<DELETED> (2) To expand innovative models of naloxone
distribution, as defined by the Secretary.</DELETED>
<DELETED> (3) To train and provide resources for health care
providers and pharmacists on the co-prescribing of opioid
overdose reversal drugs.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (5) To purchase opioid overdose reversal drugs for
distribution under the program described in paragraph
(1).</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (8) To establish protocols to connect patients who
have experienced a drug overdose with appropriate treatment,
including medication assisted treatment and 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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (f) Definition.--In this section, the term ``co-
prescribing'' has the meaning given such term in section 4.</DELETED>
<DELETED>SEC. 6. AUTHORIZATION OF APPROPRIATIONS.</DELETED>
<DELETED> There is authorized to be appropriated to carry out this
Act $2,500,000 for each of fiscal years 2016 through 2020.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Co-Prescribing Saves Lives Act of
2016''.
SEC. 2. 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, as
appropriate, provide information to prescribers within
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, on best practices for co-prescribing naloxone
for patients receiving chronic opioid therapy and patients
being treated for opioid use disorders.
(2) The Secretary of Defense shall, as appropriate, provide
information to prescribers within Department of Defense medical
facilities on best practices for co-prescribing naloxone for
patients receiving chronic opioid therapy and patients being
treated for opioid use disorders.
(3) The Secretary of Veterans Affairs shall, as
appropriate, provide information to prescribers within
Department of Veterans Affairs medical facilities on best
practices for co-prescribing naloxone for patients receiving
chronic opioid therapy and patients being treated for opioid
use disorders.
(b) 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.
Calendar No. 442
114th CONGRESS
2d Session
S. 2256
_______________________________________________________________________
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.
_______________________________________________________________________
April 27, 2016
Reported with an amendment