[Congressional Record (Bound Edition), Volume 162 (2016), Part 7]
[Senate]
[Pages 9376-9378]
[From the U.S. Government Publishing Office, www.gpo.gov]




               STATEMENTS ON BILLS AND JOINT RESOLUTIONS

      By Mr. DURBIN:
  S. 3075. A bill to establish programs related to prevention of 
prescription opioid misuse, and for other purposes; to the Committee on 
Finance.
  Mr. DURBIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 3075

       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;

[[Page 9377]]

       ``(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

[[Page 9378]]

     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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