[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3075 Introduced in Senate (IS)]

<DOC>






114th CONGRESS
  2d Session
                                S. 3075

  To establish programs related to prevention of prescription opioid 
                    misuse, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 16, 2016

  Mr. Durbin introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
  To establish programs related to prevention of prescription opioid 
                    misuse, 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 ``Addiction Prevention and Responsible 
Opioid Practices Act''.

SEC. 2. OPIOID ACTION PLAN.

    (a) Advisory Committee.--
            (1) New drug application.--Except as provided in paragraph 
        (4), prior to the approval of a new drug that is an opioid 
        under section 505 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355), the Commissioner of Food and Drugs shall refer 
        such drug to an advisory committee of the Food and Drug 
        Administration to seek recommendations from such Committee.
            (2) Pediatric opioid labeling.--The Commissioner of Food 
        and Drugs shall convene the Pediatric Advisory Committee of the 
        Food and Drug Administration to seek recommendations from such 
        Committee regarding a framework for the inclusion of 
        information in the labeling of drugs that are opioids relating 
        to the use of such drugs in pediatric populations before such 
        Commissioner approves any labeling changes for drugs that are 
        opioids intended for use in pediatric populations.
            (3) Public health exemption.--If the Commissioner of Food 
        and Drugs finds that referring a new opioid drug or drugs to an 
        advisory committee of the Food and Drug Administration as 
        required under paragraph (1) is not in the interest of 
        protecting and promoting public health, and has submitted a 
        notice containing the rationale for such a finding to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives, or if the matter that would be considered by 
        such advisory committee with respect to any such drug or drugs 
        concerns bioequivalence, sameness of active ingredient, or 
        other criteria applicable to applications submitted under 
        section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)), the Commissioner shall not be required to refer 
        such drug or drugs to an advisory committee as required under 
        paragraph (1).
            (4) Sunset.--Unless Congress reauthorizes paragraphs (1) 
        and (2), the requirements of such paragraphs shall cease to be 
        effective on October 1, 2022.
    (b) Education for Prescribers of Opioids.--Not later than 1 year 
after the date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and Drugs, as 
part of the Food and Drug Administration's evaluation of the Extended-
Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation 
Strategy, and in consultation with the Director of the Centers for 
Disease Control and Prevention, the Director of the National Institutes 
of Health, the Administrator of the Agency for Healthcare Research and 
Quality, the Administrator of the Drug Enforcement Administration, and 
relevant stakeholders, shall develop recommendations regarding 
education programs for prescribers of opioids required to be 
disseminated under section 505-1 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355-1), including recommendations for which 
prescribers should participate in such programs and how often 
participation in such programs is necessary.
    (c) Guidance.--Not later than 1 year after the date of enactment of 
this Act, the Commissioner of Food and Drugs shall issue guidance on if 
and how the approved labeling of a drug that is an opioid and is the 
subject of an application under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)) may include statements that 
such drug deters abuse.

SEC. 3. OPIOID INFORMATIONAL DOCUMENTS.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
after section 505-1 the following:

``SEC. 505-2. OPIOID INFORMATIONAL DOCUMENTS.

    ``(a) Development of Materials.--The Commissioner shall develop 
informational documents describing to consumers of opioid drugs the 
risk factors for opioid-related harm, and shall submit such documents 
to the Director of the Centers for Disease Control and Prevention for 
approval.
    ``(b) Labeling Requirement.--The manufacturer of any opioid drug 
approved under section 505 shall ensure that the appropriate 
informational documents developed under subsection (a), and approved by 
the Director of the Centers for Disease Control and Prevention, are 
included in the labeling of such drug.''.
    (b) Enforcement.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(dd) If it is an opioid drug and the labeling does not include 
the informational documents required under section 505-2.''.

SEC. 4. STRENGTHENING CONSIDERATIONS FOR DEA NARCOTIC QUOTAS.

    Section 306 of the Controlled Substances Act (21 U.S.C. 826) is 
amended by adding at the end the following:
    ``(i)(1) In fixing manufacturing quotas under this section the 
Attorney General shall take into consideration the impact of the 
manufacturing quotas on diversion and efforts to reduce the costs, 
injuries, and deaths associated with the abuse of prescription opioids 
and heroin in the United States.
    ``(2)(A) Not later than 1 year after the date of enactment of this 
subsection and every year thereafter, the Attorney General shall 
publish the approved manufacturing quota for each manufacturer of 
fentanyl, oxycodone, hyrdocodone, oxymorphone, and hyrdomorphone for 
that year.
    ``(B) For any year in which the approved manufacturing quota for a 
manufacturer for any substance described in subparagraph (A) is higher 
than the approved manufacturing quota for a manufacturer for the 
substance in the previous year, the Attorney General shall publish a 
report explaining why the public health benefits of increasing such 
quota outweigh the consequences of having an increased volume of such 
substance available for sale, and potential diversion, in the United 
States.
    ``(C) For any substance described in subparagraph (A) that is 
approved under section 505 of the Federal Food, Drug, and Cosmetic Act 
after the date of enactment of this subsection, the Attorney General 
shall publish a report explaining what factors were taken into 
consideration in setting the manufacturing quota for the substance.
    ``(3) Not later than 90 days after the date of enactment of this 
subsection, the Attorney General shall submit to Congress a report on--
            ``(A) how the Attorney General will ensure that the process 
        of fixing manufacturing quotas under this section takes into 
        consideration efforts to reduce the costs, injuries, and deaths 
        associated with the abuse of prescription opioids and heroin;
            ``(B) formal steps that will be taken to improve data 
        collection from approved drug collection receptacles, mail-back 
        programs, and take-back events on the volume and class of 
        controlled substances that are collected; and
            ``(C) how the information described in subparagraphs (A) 
        and (B) will influence the quota-setting process of the 
        Attorney General in the following year.''.

SEC. 5. CONTINUING MEDICAL EDUCATION AND PRESCRIPTION DRUG MONITORING 
              PROGRAM REGISTRATION 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, III, 
or IV, unless the practitioner submits to the Attorney General, for 
each such registration or renewal request, a written certification 
that--
            ``(A)(i) the practitioner has, during the 1-year period 
        preceding the registration or renewal request, completed a 
        training program described in paragraph (2); or
            ``(ii) the practitioner, during the applicable registration 
        period, will not prescribe such controlled substances in 
        amounts in excess of a 72-hour supply (for which no refill is 
        available); and
            ``(B) the practitioner has registered with the prescription 
        drug monitoring program of the State in which the practitioner 
        practices, if the State has such program.
    ``(2) A training program described in this paragraph is a training 
program that--
            ``(A) follows the best practices for pain management, as 
        described in the `Guideline for Prescribing Opioids for Chronic 
        Pain' as published by the Centers for Disease Control and 
        Prevention in 2016, or any successor thereto;
            ``(B) includes information on--
                    ``(i) recommending non-opioid and non-
                pharmacological therapy;
                    ``(ii) establishing treatment goals and evaluating 
                patient risks;
                    ``(iii) prescribing the lowest dose and fewest 
                number of pills considered effective;
                    ``(iv) addictive and overdose risks of opioids;
                    ``(v) diagnosing and managing substance use 
                disorders, including linking patients to evidence-based 
                treatment;
                    ``(vi) identifying narcotics-seeking behaviors; and
                    ``(vii) using prescription drug monitoring 
                programs; and
            ``(C) is approved by the Secretary of Health and Human 
        Services.''.

SEC. 6. REPORT ON PRESCRIBER EDUCATION COURSES FOR MEDICAL AND DENTAL 
              STUDENTS.

    Each school of medicine, school of osteopathic medicine, and school 
of dentistry participating in a program under title IV of the Higher 
Education Act of 1965 (20 U.S.C. 1070a et seq.), as a condition for 
such participation, shall submit an annual report to Congress on any 
prescriber education courses focused specifically on pain management 
and responsible opioid prescribing practices that such school requires 
students to take, and whether such courses are consistent with the most 
recently published version of the ``Guideline for Prescribing Opioids 
for Chronic Pain'' of the Centers for Disease Control and Prevention.

SEC. 7. REQUIREMENTS UNDER PRESCRIPTION DRUG MONITORING PROGRAMS.

    (a) In General.--Beginning 1 year after the date of enactment of 
this Act, each State that receives funding under the Harold Rogers 
Prescription Drug Monitoring Program established under the Departments 
of Commerce, Justice, and State, the Judiciary, and Related Agencies 
Appropriations Act, 2002 (Public Law 107-77; 115 Stat. 748), the 
controlled substance monitoring program under section 399O of the 
Public Health Service Act (42 U.S.C. 280g-3), or the Prescription Drug 
Overdose: Prevention for States program of the Centers for Disease 
Control and Prevention shall--
            (1) require practitioners, or their designees, in the State 
        to consult the database of the prescription drug monitoring 
        program before writing prescriptions for controlled substances 
        (as such term is defined in section 102 of the Controlled 
        Substances Act (21 U.S.C. 802)) in schedule II, III, or IV 
        under section 202 of such Act (21 U.S.C. 812);
            (2) require dispensers of controlled substances in schedule 
        II, III, or IV, or their designees, to input data into the 
        database of the prescription drug monitoring program within 24 
        hours of filling a qualifying prescription, as required by the 
        Attorney General and the Secretary of Health and Human 
        Services, including patient identifier information, the 
        national drug code of the dispensed drug, date of dispensing 
        the drug, quantity and dosage of the drug dispensed, form of 
        payment, Drug Enforcement Administration registration number of 
        the practitioner, Drug Enforcement Administration registration 
        number of the dispenser;
            (3) allow practitioners and dispensers to designate other 
        appropriate individuals to act as agents of such practitioners 
        and dispensers for purposes of obtaining and inputing data from 
        the database for purposes of complying with paragraphs (1) and 
        (2), as applicable;
            (4) provide informational materials for practitioners and 
        dispensers to identify and refer patients with possible 
        substance use disorders to professional treatment specialists;
            (5) establish formal data sharing agreements to foster 
        electronic connectivity with the prescription drug monitoring 
        programs of each State (if such State has such a program) with 
        which the State shares a border, to facilitate the exchange of 
        information through an established technology architecture that 
        ensures common data standards, privacy protection, and secure 
        and streamlined information sharing;
            (6) notwithstanding section 399O(f)(1)(B) of the Public 
        Health Service Act (42 U.S.C. 280g-3(f)(1)(B)), authorize 
        direct access to the State's database of the prescription drug 
        monitoring program to all State law enforcement agencies, State 
        boards responsible for the licensure, regulation, or discipline 
        of practitioners, pharmacists, or other persons authorized to 
        prescribe, administer, or dispense controlled substances; and
            (7) in order to enhance accountability in prescribing and 
        dispensing patterns, not fewer than 4 times per year, 
        proactively provide informational reports on aggregate trends 
        and individual outliers, based on information available through 
        the State prescription drug monitoring program to--
                    (A) the State entities and persons described in 
                paragraph (6); and
                    (B) the Medicaid agency, workers compensation 
                programs, and the department of public health of the 
                State.
    (b) Transparency in Prescribing Practices and Intervention for High 
Prescribers.--
            (1) State reporting requirement.--Each State that receives 
        funding under the Harold Rogers Prescription Drug Monitoring 
        Program established under the Departments of Commerce, Justice, 
        and State, the Judiciary, and Related Agencies Appropriations 
        Act, 2002 (Public Law 107-77; 115 Stat. 748), the controlled 
        substance monitoring program under section 399O of the Public 
        Health Service Act (42 U.S.C. 280g-3), or the Prescription Drug 
        Overdose: Prevention for States program of the Centers for 
        Disease Control and Prevention shall, twice per year, submit to 
        the Secretary of Health and Human Services and the 
        Administrator of the Drug Enforcement Administration--
                    (A) a list of all practitioners and dispensers who, 
                in the applicable reporting period, have prescribed or 
                dispensed schedule II, III, or IV opioids in the State;
                    (B) the amount of schedule II, III, or IV opioids 
                that were prescribed and dispensed by each individual 
                practitioner and dispenser described in subparagraph 
                (A); and
                    (C) any additional information that the Secretary 
                and Administrator may require to support surveillance 
                and evaluation of trends in prescribing or dispensing 
                of schedule II, III, or IV opioids, or to identify 
                possible non-medical use and diversion of such 
                substances.
            (2) Annual report.--Not later than 1 year after the date of 
        enactment of this Act, and annually thereafter, the Secretary 
        of Health and Human Services, in consultation with the 
        Administrator of the Drug Enforcement Administration, the 
        Secretary of Defense, the Secretary of Veterans Affairs, and 
        the Director of the Indian Health Service, shall submit to 
        Congress, and make public, a report identifying the geographic 
        areas with the highest rates of opioid prescribing in the 
        Nation, by zip code.
            (3) Development of action plan.--
                    (A) Initial plan.--Not later than 1 year after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services, in consultation with the 
                Administrator of the Drug Enforcement Administration, 
                the Secretary of Defense, the Secretary of Veterans 
                Affairs, and the Director of the Indian Health Service, 
                shall submit to Congress a plan of action, including 
                warning letters and enforcement mechanisms, for 
                addressing outliers in opioid prescribing practices and 
                ensuring an adequate Federal response to protect the 
                public health.
                    (B) Updated plan.--The Secretary of Health and 
                Human Services shall submit to Congress updates to the 
                plan of action described in subparagraph (A), as such 
                Secretary, in consultation with the heads of agencies 
                described in such subparagraph, determines appropriate.
    (c) Definitions.--In this section, the terms ``dispenser'' and 
``practitioner'' have the meanings given such terms in section 102 of 
the Controlled Substances Act (21 U.S.C. 802).
    (d) Authorization of Appropriations.--In addition to any other 
amounts appropriated to carry out the Prescription Drug Overdose: 
Prevention for States program of the Centers for Disease Control and 
Prevention, for purposes of enhancing the utilization, 
interoperability, and integration of State prescription drug monitoring 
programs, there are authorized to be appropriated $70,000,000 for each 
of fiscal years 2017 through 2021.

SEC. 8. DEVELOPMENT OF NEW PAIN-RELATED MEASURES UNDER THE MEDICARE 
              HOSPITAL VALUE-BASED PURCHASING PROGRAM TO ELIMINATE 
              FINANCIAL INCENTIVES TO OVER-PRESCRIBE OPIOIDS.

    Section 1886(o)(2)(B) of the Social Security Act (42 U.S.C. 
1395ww(o)(2)(B)) is amended--
            (1) in clause (i)(II), by inserting ``, subject to clause 
        (iii),'' after ``shall''; and
            (2) by adding at the end the following new clause:
                            ``(iii) Development of new pain-related 
                        measures.--
                                    ``(I) Moratorium until new measures 
                                applicable.--For value-based incentive 
                                payments made with respect to 
                                discharges occurring during fiscal year 
                                2018 and each subsequent fiscal year 
                                (before the first fiscal year in which 
                                new measures are applicable under 
                                subclause (II)(cc)), the Secretary 
                                shall ensure that measures selected 
                                under subparagraph (A) (such as 
                                measures related to the Hospital 
                                Consumer Assessment of Healthcare 
                                Providers and Systems survey) do not 
                                include measures based on any 
                                assessments by patients, with respect 
                                to hospital stays of such patients, 
                                of--
                                            ``(aa) the need of such 
                                        patients, during such stay, for 
                                        medicine for pain;
                                            ``(bb) how often, during 
                                        such stay, the pain of such 
                                        patients was well controlled; 
                                        or
                                            ``(cc) how often, during 
                                        such stay, the staff of the 
                                        hospital in which such stay 
                                        occurred did everything they 
                                        could to help the patient with 
                                        the pain experienced by the 
                                        patient.
                                    ``(II) Development of new 
                                measures.--
                                            ``(aa) Development.--Not 
                                        later than 3 years after the 
                                        date of enactment of this 
                                        clause, the Secretary shall 
                                        develop measures of patient 
                                        experience of care with respect 
                                        to pain management that balance 
                                        the breadth of effective pain 
                                        management tools with awareness 
                                        for the role of over-
                                        prescribing (including, if 
                                        appropriate, opioid-seeking 
                                        behaviors) in the prescription 
                                        opioid epidemic.
                                            ``(bb) Consultation.--The 
                                        Secretary shall consult with 
                                        relevant stakeholders in 
                                        developing measures under item 
                                        (aa).
                                            ``(cc) Application for 
                                        value-based incentive 
                                        payments.--For value-based 
                                        incentive payments made with 
                                        respect to discharges occurring 
                                        during a fiscal year beginning 
                                        on or after the date on which 
                                        the Secretary develops new 
                                        measures under item (aa), the 
                                        Secretary shall ensure that 
                                        measures selected under 
                                        subparagraph (A) (such as 
                                        measures related to the 
                                        Hospital Consumer Assessment of 
                                        Healthcare Providers and 
                                        Systems survey) include such 
                                        new measures.''.

SEC. 9. NATIONAL ACADEMY OF MEDICINE STUDY.

    (a) Study.--The Secretary of Health and Human Services shall enter 
into a contract with the National Academy of Medicine to carry out a 
study on the addition of coverage under the Medicare program under 
title XVIII of the Social Security Act of alternative treatment 
modalities (such as integrative medicine, including acupuncture and 
exercise therapy, neural stimulation, biofeedback, radiofrequency 
ablation, and trigger point injections) furnished to Medicare 
beneficiaries who suffer from acute or chronic lower back pain. Such 
study shall, pursuant to the contract under this paragraph, include an 
analysis of--
            (1) scientific research on the short-term and long-term 
        impact of the addition of such coverage on clinical efficacy 
        for pain management of such beneficiaries;
            (2) whether the lack of Medicare coverage for alternative 
        treatment modalities impacts the volume of opioids prescribed 
        for beneficiaries; and
            (3) the cost to the Medicare program of the addition of 
        such coverage to treat pain and mitigate the progression of 
        chronic pain, as weighed against the cost of opioid use 
        disorder, overdose, readmission, subsequent surgeries, and 
        utilization and expenditures under parts B and D of such title.
    (b) Report.--Not later than 1 year after the date of enactment of 
this Act, pursuant to the contract under subsection (a), the National 
Academy of Medicine shall submit to Congress a report on the study 
under subsection (a).
    (c) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated such sums as may be necessary.

SEC. 10. EXCISE TAX ON OPIOID PAIN RELIEVERS.

    (a) In General.--Subchapter E of chapter 32 of the Internal Revenue 
Code of 1986 is amended by adding at the end the following new section:

``SEC. 4192. OPIOID PAIN RELIEVERS.

    ``(a) In General.--There is hereby imposed on the manufacturer or 
producer of any taxable active opioid a tax equal to the amount 
determined under subsection (b).
    ``(b) Amount Determined.--The amount determined under this 
subsection with respect to a manufacturer or producer for a calendar 
year is 1 cent per milligram of taxable active opioid in the production 
or manufacturing quota determined for such manufacturer or producer for 
the calendar year under section 306 of the Controlled Substances Act 
(21 U.S.C. 826).
    ``(c) Taxable Active Opioid.--For purposes of this section--
            ``(1) In general.--The term `taxable active opioid' means 
        any controlled substance (as defined in section 102 of the 
        Controlled Substances Act (21 U.S.C. 802), as in effect on the 
        date of the enactment of this section) manufactured in the 
        United States which is opium, an opiate, or any derivative 
        thereof.
            ``(2) Exclusions.--
                    ``(A) Other ingredients.--In the case of a product 
                that includes a taxable active opioid and another 
                ingredient, subsection (a) shall apply only to the 
                portion of such product that is a taxable active 
                opioid.
                    ``(B) Drugs used in addiction treatment.--The term 
                `taxable active opioid' shall not include any 
                controlled substance (as so defined) which is used 
                exclusively for the treatment of opioid addiction as 
                part of a medication-assisted treatment.''.
    (b) Clerical Amendments.--
            (1) The heading of subchapter E of chapter 32 of the 
        Internal Revenue Code of 1986 is amended by striking ``Medical 
        Devices'' and inserting ``Other Medical Products''.
            (2) The table of subchapters for chapter 32 of such Code is 
        amended by striking the item relating to subchapter E and 
        inserting the following new item:

               ``subchapter e. other medical products''.

            (3) The table of sections for subchapter E of chapter 32 of 
        such Code is amended by adding at the end the following new 
        item:

``Sec. 4192. Opioid pain relievers.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to calendar years beginning after the date of the enactment of 
this Act.

SEC. 11. OPIOID CONSUMER ABUSE REDUCTION PROGRAM.

    (a) Opioid Take-Back Program.--Section 302 of the Controlled 
Substances Act (21 U.S.C. 822) is amended by adding at the end the 
following:
    ``(h)(1) The Attorney General shall establish a national take-back 
program for the safe and environmentally responsible disposal of 
controlled substances.
    ``(2) In establishing the take-back program required under 
paragraph (1), the Attorney General--
            ``(A) shall consult with the Secretary and the 
        Administrator of the Environmental Protection Agency; and
            ``(B) may coordinate with States, law enforcement agencies, 
        water resource management agencies, manufacturers, 
        practitioners, pharmacists, public health entities, 
        transportation and incineration service contractors, and other 
        entities and individuals, as appropriate.
    ``(3) The take-back program established under paragraph (1)--
            ``(A) shall--
                    ``(i) ensure appropriate geographic distribution so 
                as to provide--
                            ``(I) reasonably convenient and equitable 
                        access to permanent take-back locations, 
                        including not less than 1 disposal site for 
                        every 25,000 residents and not less than 1 
                        physical disposal site per town, city, county, 
                        or other unit of local government, where 
                        possible; and
                            ``(II) periodic collection events and mail-
                        back programs, including public notice of such 
                        events and programs, as a supplement to the 
                        permanent take-back locations described in 
                        subclause (I), particularly in areas in which 
                        the provision of access to such locations at 
                        the level described in that subclause is not 
                        possible;
                    ``(ii) establish a process for the accurate 
                cataloguing and reporting of the quantities of 
                controlled substances collected; and
                    ``(iii) include a public awareness campaign and 
                education of practitioners and pharmacists; and
            ``(B) may work in coordination with State and locally 
        implemented public and private take-back programs.
    ``(4) From time to time, beginning in the second calendar year that 
begins after the date of enactment of this subsection, the Secretary of 
the Treasury shall transfer from the general fund of the Treasury an 
amount equal to one-half of the total amount of taxes collected under 
section 4192 of the Internal Revenue Code of 1986 to the Attorney 
General to carry out this subsection. Amounts transferred under this 
subparagraph shall remain available until expended.''.
    (b) Funding of Substance Abuse Programs.--From time to time, 
beginning in the second calendar year that begins after the date of 
enactment of this Act, the Secretary of the Treasury shall transfer 
from the general fund of the Treasury an amount equal to one-half of 
the total amount of taxes collected under section 4192 of the Internal 
Revenue Code of 1986, as added by this Act, to the Director of the 
Center for Substance Abuse Treatment of the Substance Abuse and Mental 
Health Services Administration for programs of the Center, including 
the Block Grants for Prevention and Treatment of Substance Abuse 
program under subpart II of part B of title XIX of the Public Health 
Service Act (42 U.S.C. 300x-21 et seq.) and Programs of Regional and 
National Significance. Amounts transferred under this subsection shall 
remain available until expended.

SEC. 12. GAO STUDY.

    Not later than 1 year after the date of enactment of this Act, the 
Comptroller General of the United States shall conduct a study 
evaluating the various State laws, commercial insurance methods, and 
existing research on requirements that place limitations on opioid 
prescribing practices and provide analysis on best practices to address 
over-prescribing of opioids, while ensuring that individuals who need 
such opioids can access them safely. Such study shall provide 
recommendations, including with respect to--
            (1) limiting first-time opioid prescriptions to a patient 
        for acute pain to a 72-hour supply;
            (2) allowing patients or practitioners to request that a 
        prescription for a schedule II opioid be partially filled by a 
        pharmacist; and
            (3) pain management treatment contracts between 
        practitioners and patients that establish informed consent 
        regarding the expectations, risks, long-term effects, and 
        benefits of the course of opioid treatment, treatment goals, 
        the potential for opioid misuse, abuse, or diversion, and 
        requirements and responsibilities of patients, such as 
        submitting to a urine drug screening.
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