[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3680 Referred in Senate (RFS)]
<DOC>
114th CONGRESS
2d Session
H. R. 3680
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 12, 2016
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
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 6 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 5-
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) 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)''.
Passed the House of Representatives May 11, 2016.
Attest:
KAREN L. HAAS,
Clerk.