[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4482 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 4482

     To deter opioid abuse and addiction, to establish additional 
registration requirements for prescribers of opioids, to encourage the 
  development of abuse-deterrent formulations, to require a study and 
   report on policy changes that may have contributed to the opioid 
                   epidemic, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 29, 2017

  Mr. Meadows (for himself and Mr. Renacci) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
   in addition to the Committee on the Judiciary, 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 deter opioid abuse and addiction, to establish additional 
registration requirements for prescribers of opioids, to encourage the 
  development of abuse-deterrent formulations, to require a study and 
   report on policy changes that may have contributed to the opioid 
                   epidemic, 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 ``Opioid Abuse Deterrence, Research, 
and Recovery Act of 2017''.

SEC. 2. REGISTRATION REQUIREMENTS FOR PRESCRIBERS.

    Section 303 of the Controlled Substances Act (21 U.S.C. 823) is 
amended by adding at the end the following:
    ``(k)(1) The Attorney General shall not register, or renew the 
registration of, a practitioner under subsection (f) who is licensed 
under State law to prescribe controlled substances in schedule II or 
III, unless the practitioner submits to the Attorney General, for each 
such registration or renewal request, a certification that the 
practitioner, during the applicable registration period, except as 
provided in paragraph (2), will not prescribe any schedule II or III 
opioid for the initial treatment of acute pain in an amount in excess 
of the lesser of--
            ``(A) a 7-day supply (for which no refill is available); or
            ``(B) an opioid prescription limit established under the 
        law of the State where the prescribing occurs.
    ``(2) The certification required by paragraph (1) shall not 
prohibit a practitioner from--
            ``(A) prescribing, for the treatment of an opioid use 
        disorder, a schedule II or III opioid that is approved by the 
        Food and Drug Administration for such treatment;
            ``(B) prescribing, for immediate, post-operative pain 
        relief, a schedule II or III opioid; or
            ``(C) prescribing a schedule II or III opioid in an amount 
        in excess of a 7-day supply if the practitioner--
                    ``(i) provides a specific reason for exceeding the 
                7-day limit that is in accordance with a clear medical 
                standard of care whose implementation necessarily 
                exceeds such limit;
                    ``(ii) documents such reason and medical standard 
                of care in the patient's medical record; and
                    ``(iii) consults the applicable State's electronic 
                health record system or prescription drug monitoring 
                program.
    ``(3) In this subsection, the term `acute pain'--
            ``(A) means pain with abrupt onset and caused by an injury 
        or other process that is diagnostically determined to have 
        minimal risk of escalating in intensity; and
            ``(B) does not include--
                    ``(i) chronic pain;
                    ``(ii) pain being treated as part of cancer care;
                    ``(iii) hospice or other end-of-life care; or
                    ``(iv) pain being treated as part of palliative 
                care.''.

SEC. 3. ENCOURAGING DEVELOPMENT OF ABUSE-DETERRENT FORMULATIONS.

    The Commissioner of Food and Drugs shall continue to work with 
stakeholders to encourage the development of opioid formulations with 
abuse-deterrent properties.

SEC. 4. GAO STUDY AND REPORT ON POLICY CHANGES THAT MAY HAVE 
              CONTRIBUTED TO THE OPIOID EPIDEMIC.

    Not later than 2 years after the date of enactment of this Act, the 
Comptroller General of the United States shall complete a study and 
submit a report to Congress on health care policy changes that may have 
contributed to the increase in opioid overdoses and deaths during the 
10 years preceding the date of enactment of this Act. Such study shall 
include--
            (1) a review of health care-related legislative, 
        administrative, and judicial decisions by officers and 
        employees of the Federal Government that have affected access 
        to pain management strategies with an emphasis on 
        pharmaceuticals;
            (2) an analysis of what is known about the costs and 
        benefits, whether financial or non-financial, of reversing or 
        revising such decisions individually or in combination, 
        including whether the reversals or revisions would be expected 
        to achieve a reduction in abuse of, addiction to, overdose on, 
        and death from opioids;
            (3) an analysis of the differences among State-based 
        prescription drug monitoring programs, including an analysis of 
        what is known about the effects of such differences on 
        monitoring for abuse of, addiction to, overdose on, and death 
        from opioids;
            (4) an analysis of what is known about positive and 
        negative impacts that prescribing limitations, both State and 
        Federal, have on patient medical outcomes, including for 
        chronic pain patients; and
            (5) an analysis of what is known about the costs to payers 
        of using abuse-deterrent formulations of opioid pain 
        medications, compared to opioid pain medications without abuse-
        deterrent features.

SEC. 5. STUDY ON FEASIBILITY OF REPLACING STATUTORY LIMITS WITH 
              CLINICAL GUIDELINES ON OPIOID PRESCRIBING.

    The Commissioner of Food and Drugs shall--
            (1) conduct a study on the feasibility of--
                    (A) replacing the prescribing limits in section 
                303(k)(1) of the Controlled Substances Act, as added by 
                section 2 of this Act, with evidence-based clinical 
                guidelines to inform opioid selection, dosage, 
                duration, follow up, and discontinuation, including 
                guidelines on the first opioid prescription for 
                patients for an acute pain diagnosis to ensure that no 
                greater quantity than needed is prescribed for the 
                expected duration of pain severe enough to require 
                opioids; and
                    (B) the incorporation into routine medical visits 
                of evidence-based screening tools for the misuse of 
                opioids and other controlled substances; and
            (2) not later than the date that is 2 years after the date 
        of enactment of this Act, submit to the Congress, and post on 
        the public website of the Food and Drug Administration, a 
        report on the results of such study.
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