[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.
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