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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3680 Reported in House (RH)]

<DOC>

                                                 Union Calendar No. 427
114th CONGRESS
  2d Session
                                H. R. 3680

                          [Report No. 114-553]

To provide for the Secretary of Health and Human Services to carry out 
   a grant program for co-prescribing opioid overdose reversal drugs.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            October 1, 2015

 Mr. Sarbanes introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

                              May 10, 2016

  Additional sponsors: Mr. Bucshon, Mr. Hultgren, Mr. Bilirakis, Mr. 
                        Shuster, and Ms. McSally

                              May 10, 2016

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
[For text of introduced bill, see copy of bill as introduced on October 
                                1, 2015]

_______________________________________________________________________

                                 A BILL

 
To provide for the Secretary of Health and Human Services to carry out 
   a grant program for co-prescribing opioid overdose reversal drugs.

 

    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 to Reduce Overdoses 
Act of 2016''.

SEC. 2. OPIOID OVERDOSE REVERSAL DRUGS PRESCRIBING GRANT PROGRAM.

    (a) Establishment.--
            (1) In general.--Not later than six months after the date 
        of the enactment of this Act, the Secretary of Health and Human 
        Services may establish, in accordance with this section, a 
        five-year opioid overdose reversal drugs prescribing grant 
        program (in this Act referred to as the ``grant program'').
            (2) Maximum grant amount.--A grant made under this section 
        may not be for more than $200,000 per grant year.
            (3) Eligible entity.--For purposes of this section, the 
        term ``eligible entity'' means a federally qualified health 
        center (as defined in section 1861(aa) of the Social Security 
        Act (42 U.S.C. 1395x(aa)), an opioid treatment program under 
        part 8 of title 42, Code of Federal Regulations, any 
        practitioner dispensing narcotic drugs pursuant to section 
        303(g) of the Controlled Substances Act (21 U.S.C. 823(g)), or 
        any other entity that the Secretary deems appropriate.
            (4) Prescribing.--For purposes of this section and section 
        3, the term ``prescribing'' means, with respect to an opioid 
        overdose reversal drug, such as naloxone, the practice of 
        prescribing such drug--
                    (A) in conjunction with an opioid prescription for 
                patients at an elevated risk of overdose;
                    (B) 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 abuse disorder;
                    (C) to the caregiver or a close relative of 
                patients at an elevated risk of overdose from opioids; 
                or
                    (D) in other circumstances, as identified by the 
                Secretary, in which a provider identifies a patient is 
                at an elevated risk for an intentional or unintentional 
                drug overdose from heroin or prescription opioid 
                therapies.
    (b) Application.--To be eligible to receive a grant under this 
section, an eligible entity shall submit to the Secretary of Health and 
Human Services, in such form and manner as specified by the Secretary, 
an application that describes--
            (1) the extent to which the area to which the entity will 
        furnish services through use of the grant is experiencing 
        significant morbidity and mortality caused by opioid abuse;
            (2) the criteria that will be used to identify eligible 
        patients to participate in such program; and
            (3) how such program will work to try to identify State, 
        local, or private funding to continue the program after 
        expiration of the grant.
    (c) Use of Funds.--An eligible entity receiving a grant under this 
section may use the grant for any of the following activities, but may 
use not more than 20 percent of the grant funds for activities 
described in paragraphs (4) and (5):
            (1) To establish a program for prescribing opioid overdose 
        reversal drugs, such as naloxone.
            (2) To train and provide resources for health care 
        providers and pharmacists on the prescribing of opioid overdose 
        reversal drugs, such as naloxone.
            (3) To establish mechanisms and processes for tracking 
        patients participating in the program described in paragraph 
        (1) and the health outcomes of such patients.
            (4) To purchase opioid overdose reversal drugs, such as 
        naloxone, for distribution under the program described in 
        paragraph (1).
            (5) To offset the co-pays and other cost sharing associated 
        with opioid overdose reversal drugs, such as naloxone, to 
        ensure that cost is not a limiting factor for eligible 
        patients.
            (6) To conduct community outreach, in conjunction with 
        community-based organizations, designed to raise awareness of 
        prescribing practices, and the availability of opioid overdose 
        reversal drugs, such as naloxone.
            (7) 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.
    (d) Evaluations by Recipients.--As a condition of receipt of a 
grant under this section, an eligible entity shall, for each year for 
which the grant is received, submit to the Secretary of Health and 
Human Services information on appropriate outcome measures specified by 
the Secretary to assess the outcomes of the program funded by the 
grant, including--
            (1) the number of prescribers trained;
            (2) the number of prescribers who have co-prescribed an 
        opioid overdose reversal drug, such as naloxone, to at least 
        one patient;
            (3) the total number of prescriptions written for opioid 
        overdose reversal drugs, such as naloxone;
            (4) the percentage of patients at elevated risk who 
        received a prescription for an opioid overdose reversal drug, 
        such as naloxone;
            (5) the number of patients reporting use of an opioid 
        overdose reversal drug, such as naloxone; and
            (6) any other outcome measures that the Secretary deems 
        appropriate.
    (e) Reports by Secretary.--For each year of the grant program under 
this section, the Secretary of Health and Human Services shall submit 
to the appropriate committees of the House of Representatives and of 
the Senate a report aggregating the information received from the grant 
recipients for such year under subsection (d) and evaluating the 
outcomes achieved by the programs funded by grants made under this 
section.

SEC. 3. PROVIDING INFORMATION TO PRESCRIBERS IN CERTAIN FEDERAL HEALTH 
              CARE AND MEDICAL FACILITIES ON BEST PRACTICES FOR 
              PRESCRIBING OPIOID OVERDOSE REVERSAL DRUGS.

    (a) In General.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') may, 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 prescribing opioid 
overdose reversal drugs, such as naloxone, for patients receiving 
chronic opioid therapy, patients being treated for opioid use 
disorders, and other patients that a provider identifies as having an 
elevated risk of overdose from heroin or prescription opioid therapies.
    (b) Not Establishing a Medical Standard of Care.--The information 
on best practices provided under this section shall not be construed as 
constituting or establishing a medical standard of care for prescribing 
opioid overdose reversal drugs, such as naloxone, for patients 
described in subsection (a).
    (c) No Authorization of Any Additional Appropriations.--The 
Secretary shall carry out this section through funds otherwise 
appropriated and nothing in this section shall be construed as 
authorizing the appropriations of additional funds to carry out this 
section.
    (d) Elevated Risk of Overdose Defined.--In this section, the term 
``elevated risk of overdose'' has the meaning given such term by the 
Secretary, which--
            (1) may be based on the criteria provided in the Opioid 
        Overdose Toolkit published by the Substance Abuse and Mental 
        Health Services Administration (SAMHSA); and
            (2) may include patients on a first course opioid 
        treatment, patients using extended-release and long-acting 
        opioid analgesics, and patients with a respiratory disease or 
        other co-morbidities.

SEC. 4. AUTHORIZATION OF APPROPRIATIONS.

    There is authorized to be appropriated to carry out this Act 
$5,000,000 for the period of fiscal years 2017 through 2021.

SEC. 5. CUT-GO COMPLIANCE.

    Subsection (f) of section 319D of the Public Health Service Act (42 
U.S.C. 247d-4) is amended by inserting before the period at the end the 
following: ``(except such dollar amount shall be reduced by $5,000,000 
for fiscal year 2018)''.
                                                 Union Calendar No. 427

114th CONGRESS

  2d Session

                               H. R. 3680

                          [Report No. 114-553]

_______________________________________________________________________

                                 A BILL

To provide for the Secretary of Health and Human Services to carry out 
   a grant program for co-prescribing opioid overdose reversal drugs.

_______________________________________________________________________

                              May 10, 2016

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
```