[Congressional Record Volume 164, Number 65 (Monday, April 23, 2018)]
[Senate]
[Pages S2343-S2346]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN:
  S. 2729. 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. 2729

       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. FEDERAL LICENSURE OF PHARMACEUTICAL REPRESENTATIVES 
                   WHO PROMOTE CERTAIN OPIOIDS.

       Subchapter E of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding 
     at the end the following:

     ``SEC. 569D. FEDERAL LICENSURE OF PHARMACEUTICAL 
                   REPRESENTATIVES WHO PROMOTE CERTAIN OPIOIDS.

       ``(a) In General.--The Secretary, in consultation with the 
     Attorney General, shall establish a licensure program for 
     pharmaceutical representatives described in subsection (b).
       ``(b) Licensure Program.--
       ``(1) Requirement.--Beginning on January 1, 2020, no 
     individual described in paragraph (2) may engage in the 
     marketing or promoting of opioid drugs unless such individual 
     is licensed under this section.
       ``(2) Individuals required to obtain licensure.--An 
     individual required to obtain a license under this section is 
     any individual who, on behalf of a drug manufacturer, 
     engaged, on more than 15 days in a calendar year, in the 
     marketing or promotion to health care professionals, 
     including educational or sales communications, meetings or 
     paid events, and the provision of goods, gifts, and samples, 
     of any opioid drug (other than methadone) that is listed in 
     schedule II of section 202(c) of the Controlled Substances 
     Act.
       ``(3) Licensure period.--Each license issued under this 
     section shall be valid for 3 years, and may be renewed for 
     additional 3-year periods.
       ``(c) Requirements.--An individual required to obtain a 
     license under this section shall--
       ``(1) submit to the Secretary, at such time and in such 
     manner as the Secretary may require--
       ``(A) such information as the Secretary may require; and
       ``(B) a registration fee in the amount of $3,000;
       ``(2) certify that such individual has completed training 
     on ethics, pharmaceutical marketing regulations, the `CDC 
     Guidelines for Prescribing Opioids for Chronic Pain', 
     published by the Centers for Disease Control and Prevention 
     in 2016 (or any successor document) or the `FDA Blueprint for 
     Prescriber Education for Extended-Release and Long-Acting 
     Opioid Analgesics', and applicable Federal laws pertaining to 
     drug marketing, labeling, and clinical trials, as the 
     Secretary may require;
       ``(3) certify that such individual will not engage in any 
     illegal, fraudulent, misleading, or other deceptive marketing 
     of schedule II opioid drugs; and
       ``(4) file with the Secretary annual reports disclosing the 
     names of providers visited and any drug samples or gifts such 
     individual gives any such provider.
       ``(d) Manufacturer Reporting Requirements.--The 
     manufacturer who employs or contracts with any individual 
     required to obtain a license under this section shall include 
     in reports required under section 1128G

[[Page S2344]]

     of the Social Security Act the name of each such licensed 
     individual that provides payments or other transfers of value 
     required to be reported under such section 1128G that relates 
     to an opioid drug that is listed in schedule II of the 
     Controlled Substances Act.''.

     SEC. 3. WITHDRAWAL OF APPROVAL OF CERTAIN OPIOIDS.

       (a) In General.--Notwithstanding any other provision of 
     law, any ultra-high-dose opioid shall be considered a drug 
     that presents an imminent hazard to the public health within 
     the meaning of section 505(e) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(e)), and the Secretary of Health 
     and Human Services shall suspend the approval of such drug, 
     in accordance with such section 505(e).
       (b) Definition.--In this section, the term ``ultra-high-
     dose opioid'' means an opioid drug for which the daily dosage 
     provided for in the approved label exceeds the morphine 
     milligram equivalents per day outlined in the report entitled 
     ``CDC Guidelines for Prescribing Opioids for Chronic Pain'', 
     published by the Centers for Disease Control and Prevention 
     in 2016 (or any successor document).

     SEC. 4. EXPANDING AVAILABILITY OF INFORMATION IN THE ARCOS 
                   DATABASE.

       Section 307(d) of the Controlled Substances Act (21 U.S.C. 
     827(d)) is amended by adding at the end the following:
       ``(3) The Attorney General shall make available to the 
     medical licensing board and board of pharmacy for each State 
     the information in the Automation of Reports and Consolidated 
     Orders System, or any subsequent automated system developed 
     by the Attorney General to monitor the sale, delivery, and 
     disposal of controlled substances within such State.''.

     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, or the `FDA 
     Blueprint for Prescriber Education for Extended-Release and 
     Long-Acting Opioid Analgesics' as published by the Food and 
     Drug Administration in 2017, 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 the Secretary of Education and the 
     Secretary of Health and Human Services 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 or the ``FDA 
     Blueprint for Prescriber Education for Extended-Release and 
     Long-Acting Opioid Analgesics'', as published by the Food and 
     Drug Administration in 2017. The Secretary of Education and 
     the Secretary of Health and Human Services shall compile the 
     reports submitted by such schools and submit an annual 
     summary of such reports to Congress.

     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 
     any of the programs described in subsection (c) 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 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 any of the programs described in subsection (c) 
     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 outliers 
     among the medical specialties and 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) Programs Described.--The programs described in this 
     subsection are--
       (1) the Harold Rogers Prescription Drug Monitoring Program 
     established under the Departments of Commerce, Justice, and 
     State, the Judiciary, and Related Agencies

[[Page S2345]]

     Appropriations Act, 2002 (Public Law 107-77; 115 Stat. 748);
       (2) the controlled substance monitoring program under 
     section 399O of the Public Health Service Act (42 U.S.C. 
     280g-3);
       (3) the Prescription Drug Overdose: Prevention for States 
     program of the Centers for Disease Control and Prevention;
       (4) the Prescription Drug Overdose: Data-Driven Prevention 
     Initiative of Centers for Disease Control and Prevention;
       (5) the Enhanced State Opioid Overdose Surveillance program 
     of the Centers for Disease Control and Prevention;
       (6) the opioid grant program under section 1003 of the 21st 
     Century Cures Act (Public Law 114-255); and
       (7) the State Opioid Response Grant program described under 
     the heading ``substance abuse treatment'' under the heading 
     ``Substance Abuse and Mental Health Services Administration'' 
     of title II of division H of the Consolidated Appropriations 
     Act, 2018 (Public Law 115-141).
       (d) 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).

     SEC. 8. INTEROPERABILITY OF CERTIFIED HEALTH INFORMATION 
                   TECHNOLOGY.

       Section 3001(c)(5) of the Public Health Service Act (42 
     U.S.C. 300jj-11(c)(5)) is amended by adding at the end the 
     following:
       ``(F) Interoperability.--Beginning on January 1, 2021, the 
     National Coordinator shall not certify electronic health 
     records as health information technology that is in 
     compliance with applicable certification criteria under this 
     paragraph unless such technology is interoperable with the 
     prescription drug monitoring programs of each State that, at 
     the time of the request for such certification, has such a 
     program.''.

     SEC. 9. STUDIES RELATED TO OVERDOSE DISCHARGE AND FOLLOW-UP 
                   POLICIES.

       (a) Study.--Not later than January 1, 2021, the Secretary 
     of Health and Human Services shall--
       (1) conduct a study on the scope and circumstances of non-
     fatal opioid overdoses, the policies and procedures that 
     States, health care systems, and first responders have 
     implemented; and
       (2) in partnership with stakeholder organizations with 
     subject matter expertise, establish guidelines for hospital 
     procedures following non-fatal opioid overdose and the 
     administration of overdose reversal medication.
       (b) Study and Development of Quality Measures Under 
     Medicare Related to Opioid Abuse and Substance Use 
     Disorder.--Section 1890A(e) of the Social Security Act (42 
     U.S.C. 1395aaa-1(e)) is amended--
       (1) by striking ``Measures.--The Administrator'' and 
     inserting ``Measures.--
       ``(1) In general.--The Administrator''; and
       (2) by adding at the end the following new paragraph:
       ``(2) Study and development of quality measures related to 
     opioid abuse and substance use disorder.--Beginning not later 
     than 1 year after the date of enactment of this paragraph, 
     the Administrator of the Center for Medicare and Medicaid 
     Services shall study and through contracts develop, in 
     coordination with appropriate subject matter organizations 
     (such as the entity with a contract under section 1890), for 
     use under this Act, quality measures related to standards of 
     care for treating individuals with non-fatal opioid overdose, 
     discharge procedures, and linkages to appropriate substance 
     use disorder treatment and community support services.''.

     SEC. 10. MEDICAID OPIOID DRUG MAPPING TOOL.

       (a) In General.--The Secretary of Health and Human Services 
     shall create an interactive opioid drug mapping tool, which 
     shall be made publicly available on the internet website of 
     the Centers for Medicare & Medicaid Services, showing 
     prescribing practices of providers that participate in State 
     Medicaid programs and geographic comparisons, at the State, 
     county, and ZIP code levels, of de-identified opioid 
     prescription claims made under State Medicaid programs under 
     title XIX of the Social Security Act (42 U.S.C. 1396 et 
     seq.).
       (b) Collection of Data From States.--The Secretary of 
     Health and Human Services may request from States such data 
     as the Secretary determines necessary to create the opioid 
     mapping tool described in subsection (a).

     SEC. 11. 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. 12. 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. 13. 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

[[Page S2346]]

     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. 14. 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) requiring non-opioid pain treatments to be front line 
     therapies;
       (2) limiting first-time opioid prescriptions to a patient 
     for acute pain to a 72-hour supply; 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.
                                 ______