Title: Addiction Prevention and Responsible Opioid Practices Act
Policy area: Health

Summary:
Addiction Prevention and Responsible Opioid Practices Act
This bill establishes a series of requirements relating to opioid regulation, prescribing, and monitoring, including licensure requirements for pharmaceutical representatives, a national opioid drug mapping tool to monitor prescribing practices of Medicaid providers, and an excise tax on opioid manufacturers.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2729 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  2d Session
                                S. 2729

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 23, 2018

  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. 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 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 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 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.
                                 <all>