[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