[Congressional Record Volume 162, Number 96 (Thursday, June 16, 2016)]
[Senate]
[Pages S4301-S4303]
From the Congressional Record Online through the 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
[[Page S4302]]
``(B) the practitioner has registered with the prescription
drug monitoring program of the State in which the
practitioner practices, if the State has such program.
``(2) A training program described in this paragraph is a
training program that--
``(A) follows the best practices for pain management, as
described in the `Guideline for Prescribing Opioids for
Chronic Pain' as published by the Centers for Disease Control
and Prevention in 2016, or any successor thereto;
``(B) includes information on--
``(i) recommending non-opioid and non-pharmacological
therapy;
``(ii) establishing treatment goals and evaluating patient
risks;
``(iii) prescribing the lowest dose and fewest number of
pills considered effective;
``(iv) addictive and overdose risks of opioids;
``(v) diagnosing and managing substance use disorders,
including linking patients to evidence-based treatment;
``(vi) identifying narcotics-seeking behaviors; and
``(vii) using prescription drug monitoring programs; and
``(C) is approved by the Secretary of Health and Human
Services.''.
SEC. 6. REPORT ON PRESCRIBER EDUCATION COURSES FOR MEDICAL
AND DENTAL STUDENTS.
Each school of medicine, school of osteopathic medicine,
and school of dentistry participating in a program under
title IV of the Higher Education Act of 1965 (20 U.S.C. 1070a
et seq.), as a condition for such participation, shall submit
an annual report to Congress on any prescriber education
courses focused specifically on pain management and
responsible opioid prescribing practices that such school
requires students to take, and whether such courses are
consistent with the most recently published version of the
``Guideline for Prescribing Opioids for Chronic Pain'' of the
Centers for Disease Control and Prevention.
SEC. 7. REQUIREMENTS UNDER PRESCRIPTION DRUG MONITORING
PROGRAMS.
(a) In General.--Beginning 1 year after the date of
enactment of this Act, each State that receives funding under
the Harold Rogers Prescription Drug Monitoring Program
established under the Departments of Commerce, Justice, and
State, the Judiciary, and Related Agencies Appropriations
Act, 2002 (Public Law 107-77; 115 Stat. 748), the controlled
substance monitoring program under section 399O of the Public
Health Service Act (42 U.S.C. 280g-3), or the Prescription
Drug Overdose: Prevention for States program of the Centers
for Disease Control and Prevention shall--
(1) require practitioners, or their designees, in the State
to consult the database of the prescription drug monitoring
program before writing prescriptions for controlled
substances (as such term is defined in section 102 of the
Controlled Substances Act (21 U.S.C. 802)) in schedule II,
III, or IV under section 202 of such Act (21 U.S.C. 812);
(2) require dispensers of controlled substances in schedule
II, III, or IV, or their designees, to input data into the
database of the prescription drug monitoring program within
24 hours of filling a qualifying prescription, as required by
the Attorney General and the Secretary of Health and Human
Services, including patient identifier information, the
national drug code of the dispensed drug, date of dispensing
the drug, quantity and dosage of the drug dispensed, form of
payment, Drug Enforcement Administration registration number
of the practitioner, Drug Enforcement Administration
registration number of the dispenser;
(3) allow practitioners and dispensers to designate other
appropriate individuals to act as agents of such
practitioners and dispensers for purposes of obtaining and
inputing data from the database for purposes of complying
with paragraphs (1) and (2), as applicable;
(4) provide informational materials for practitioners and
dispensers to identify and refer patients with possible
substance use disorders to professional treatment
specialists;
(5) establish formal data sharing agreements to foster
electronic connectivity with the prescription drug monitoring
programs of each State (if such State has such a program)
with which the State shares a border, to facilitate the
exchange of information through an established technology
architecture that ensures common data standards, privacy
protection, and secure and streamlined information sharing;
(6) notwithstanding section 399O(f)(1)(B) of the Public
Health Service Act (42 U.S.C. 280g-3(f)(1)(B)), authorize
direct access to the State's database of the prescription
drug monitoring program to all State law enforcement
agencies, State boards responsible for the licensure,
regulation, or discipline of practitioners, pharmacists, or
other persons authorized to prescribe, administer, or
dispense controlled substances; and
(7) in order to enhance accountability in prescribing and
dispensing patterns, not fewer than 4 times per year,
proactively provide informational reports on aggregate trends
and individual outliers, based on information available
through the State prescription drug monitoring program to--
(A) the State entities and persons described in paragraph
(6); and
(B) the Medicaid agency, workers compensation programs, and
the department of public health of the State.
(b) Transparency in Prescribing Practices and Intervention
for High Prescribers.--
(1) State reporting requirement.--Each State that receives
funding under the Harold Rogers Prescription Drug Monitoring
Program established under the Departments of Commerce,
Justice, and State, the Judiciary, and Related Agencies
Appropriations Act, 2002 (Public Law 107-77; 115 Stat. 748),
the controlled substance monitoring program under section
399O of the Public Health Service Act (42 U.S.C. 280g-3), or
the Prescription Drug Overdose: Prevention for States program
of the Centers for Disease Control and Prevention shall,
twice per year, submit to the Secretary of Health and Human
Services and the Administrator of the Drug Enforcement
Administration--
(A) a list of all practitioners and dispensers who, in the
applicable reporting period, have prescribed or dispensed
schedule II, III, or IV opioids in the State;
(B) the amount of schedule II, III, or IV opioids that were
prescribed and dispensed by each individual practitioner and
dispenser described in subparagraph (A); and
(C) any additional information that the Secretary and
Administrator may require to support surveillance and
evaluation of trends in prescribing or dispensing of schedule
II, III, or IV opioids, or to identify possible non-medical
use and diversion of such substances.
(2) Annual report.--Not later than 1 year after the date of
enactment of this Act, and annually thereafter, the Secretary
of Health and Human Services, in consultation with the
Administrator of the Drug Enforcement Administration, the
Secretary of Defense, the Secretary of Veterans Affairs, and
the Director of the Indian Health Service, shall submit to
Congress, and make public, a report identifying the
geographic areas with the highest rates of opioid prescribing
in the Nation, by zip code.
(3) Development of action plan.--
(A) Initial plan.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Administrator of the Drug
Enforcement Administration, the Secretary of Defense, the
Secretary of Veterans Affairs, and the Director of the Indian
Health Service, shall submit to Congress a plan of action,
including warning letters and enforcement mechanisms, for
addressing outliers in opioid prescribing practices and
ensuring an adequate Federal response to protect the public
health.
(B) Updated plan.--The Secretary of Health and Human
Services shall submit to Congress updates to the plan of
action described in subparagraph (A), as such Secretary, in
consultation with the heads of agencies described in such
subparagraph, determines appropriate.
(c) Definitions.--In this section, the terms ``dispenser''
and ``practitioner'' have the meanings given such terms in
section 102 of the Controlled Substances Act (21 U.S.C. 802).
(d) Authorization of Appropriations.--In addition to any
other amounts appropriated to carry out the Prescription Drug
Overdose: Prevention for States program of the Centers for
Disease Control and Prevention, for purposes of enhancing the
utilization, interoperability, and integration of State
prescription drug monitoring programs, there are authorized
to be appropriated $70,000,000 for each of fiscal years 2017
through 2021.
SEC. 8. DEVELOPMENT OF NEW PAIN-RELATED MEASURES UNDER THE
MEDICARE HOSPITAL VALUE-BASED PURCHASING
PROGRAM TO ELIMINATE FINANCIAL INCENTIVES TO
OVER-PRESCRIBE OPIOIDS.
Section 1886(o)(2)(B) of the Social Security Act (42 U.S.C.
1395ww(o)(2)(B)) is amended--
(1) in clause (i)(II), by inserting ``, subject to clause
(iii),'' after ``shall''; and
(2) by adding at the end the following new clause:
``(iii) Development of new pain-related measures.--
``(I) Moratorium until new measures applicable.--For value-
based incentive payments made with respect to discharges
occurring during fiscal year 2018 and each subsequent fiscal
year (before the first fiscal year in which new measures are
applicable under subclause (II)(cc)), the Secretary shall
ensure that measures selected under subparagraph (A) (such as
measures related to the Hospital Consumer Assessment of
Healthcare Providers and Systems survey) do not include
measures based on any assessments by patients, with respect
to hospital stays of such patients, of--
``(aa) the need of such patients, during such stay, for
medicine for pain;
``(bb) how often, during such stay, the pain of such
patients was well controlled; or
``(cc) how often, during such stay, the staff of the
hospital in which such stay occurred did everything they
could to help the patient with the pain experienced by the
patient.
``(II) Development of new measures.--
``(aa) Development.--Not later than 3 years after the date
of enactment of this clause, the Secretary shall develop
measures of patient experience of care with respect to pain
management that balance the breadth of effective pain
management tools with awareness for the role of over-
prescribing (including, if appropriate, opioid-seeking
behaviors) in the prescription opioid epidemic.
``(bb) Consultation.--The Secretary shall consult with
relevant stakeholders in developing measures under item (aa).
``(cc) Application for value-based incentive payments.--For
value-based incentive payments made with respect to
discharges
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occurring during a fiscal year beginning on or after the date
on which the Secretary develops new measures under item (aa),
the Secretary shall ensure that measures selected under
subparagraph (A) (such as measures related to the Hospital
Consumer Assessment of Healthcare Providers and Systems
survey) include such new measures.''.
SEC. 9. NATIONAL ACADEMY OF MEDICINE STUDY.
(a) Study.--The Secretary of Health and Human Services
shall enter into a contract with the National Academy of
Medicine to carry out a study on the addition of coverage
under the Medicare program under title XVIII of the Social
Security Act of alternative treatment modalities (such as
integrative medicine, including acupuncture and exercise
therapy, neural stimulation, biofeedback, radiofrequency
ablation, and trigger point injections) furnished to Medicare
beneficiaries who suffer from acute or chronic lower back
pain. Such study shall, pursuant to the contract under this
paragraph, include an analysis of--
(1) scientific research on the short-term and long-term
impact of the addition of such coverage on clinical efficacy
for pain management of such beneficiaries;
(2) whether the lack of Medicare coverage for alternative
treatment modalities impacts the volume of opioids prescribed
for beneficiaries; and
(3) the cost to the Medicare program of the addition of
such coverage to treat pain and mitigate the progression of
chronic pain, as weighed against the cost of opioid use
disorder, overdose, readmission, subsequent surgeries, and
utilization and expenditures under parts B and D of such
title.
(b) Report.--Not later than 1 year after the date of
enactment of this Act, pursuant to the contract under
subsection (a), the National Academy of Medicine shall submit
to Congress a report on the study under subsection (a).
(c) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated such sums as
may be necessary.
SEC. 10. EXCISE TAX ON OPIOID PAIN RELIEVERS.
(a) In General.--Subchapter E of chapter 32 of the Internal
Revenue Code of 1986 is amended by adding at the end the
following new section:
``SEC. 4192. OPIOID PAIN RELIEVERS.
``(a) In General.--There is hereby imposed on the
manufacturer or producer of any taxable active opioid a tax
equal to the amount determined under subsection (b).
``(b) Amount Determined.--The amount determined under this
subsection with respect to a manufacturer or producer for a
calendar year is 1 cent per milligram of taxable active
opioid in the production or manufacturing quota determined
for such manufacturer or producer for the calendar year under
section 306 of the Controlled Substances Act (21 U.S.C. 826).
``(c) Taxable Active Opioid.--For purposes of this
section--
``(1) In general.--The term `taxable active opioid' means
any controlled substance (as defined in section 102 of the
Controlled Substances Act (21 U.S.C. 802), as in effect on
the date of the enactment of this section) manufactured in
the United States which is opium, an opiate, or any
derivative thereof.
``(2) Exclusions.--
``(A) Other ingredients.--In the case of a product that
includes a taxable active opioid and another ingredient,
subsection (a) shall apply only to the portion of such
product that is a taxable active opioid.
``(B) Drugs used in addiction treatment.--The term `taxable
active opioid' shall not include any controlled substance (as
so defined) which is used exclusively for the treatment of
opioid addiction as part of a medication-assisted
treatment.''.
(b) Clerical Amendments.--
(1) The heading of subchapter E of chapter 32 of the
Internal Revenue Code of 1986 is amended by striking
``Medical Devices'' and inserting ``Other Medical Products''.
(2) The table of subchapters for chapter 32 of such Code is
amended by striking the item relating to subchapter E and
inserting the following new item:
``subchapter e. other medical products''.
(3) The table of sections for subchapter E of chapter 32 of
such Code is amended by adding at the end the following new
item:
``Sec. 4192. Opioid pain relievers.''.
(c) Effective Date.--The amendments made by this section
shall apply to calendar years beginning after the date of the
enactment of this Act.
SEC. 11. OPIOID CONSUMER ABUSE REDUCTION PROGRAM.
(a) Opioid Take-back Program.--Section 302 of the
Controlled Substances Act (21 U.S.C. 822) is amended by
adding at the end the following:
``(h)(1) The Attorney General shall establish a national
take-back program for the safe and environmentally
responsible disposal of controlled substances.
``(2) In establishing the take-back program required under
paragraph (1), the Attorney General--
``(A) shall consult with the Secretary and the
Administrator of the Environmental Protection Agency; and
``(B) may coordinate with States, law enforcement agencies,
water resource management agencies, manufacturers,
practitioners, pharmacists, public health entities,
transportation and incineration service contractors, and
other entities and individuals, as appropriate.
``(3) The take-back program established under paragraph
(1)--
``(A) shall--
``(i) ensure appropriate geographic distribution so as to
provide--
``(I) reasonably convenient and equitable access to
permanent take-back locations, including not less than 1
disposal site for every 25,000 residents and not less than 1
physical disposal site per town, city, county, or other unit
of local government, where possible; and
``(II) periodic collection events and mail-back programs,
including public notice of such events and programs, as a
supplement to the permanent take-back locations described in
subclause (I), particularly in areas in which the provision
of access to such locations at the level described in that
subclause is not possible;
``(ii) establish a process for the accurate cataloguing and
reporting of the quantities of controlled substances
collected; and
``(iii) include a public awareness campaign and education
of practitioners and pharmacists; and
``(B) may work in coordination with State and locally
implemented public and private take-back programs.
``(4) From time to time, beginning in the second calendar
year that begins after the date of enactment of this
subsection, the Secretary of the Treasury shall transfer from
the general fund of the Treasury an amount equal to one-half
of the total amount of taxes collected under section 4192 of
the Internal Revenue Code of 1986 to the Attorney General to
carry out this subsection. Amounts transferred under this
subparagraph shall remain available until expended.''.
(b) Funding of Substance Abuse Programs.--From time to
time, beginning in the second calendar year that begins after
the date of enactment of this Act, the Secretary of the
Treasury shall transfer from the general fund of the Treasury
an amount equal to one-half of the total amount of taxes
collected under section 4192 of the Internal Revenue Code of
1986, as added by this Act, to the Director of the Center for
Substance Abuse Treatment of the Substance Abuse and Mental
Health Services Administration for programs of the Center,
including the Block Grants for Prevention and Treatment of
Substance Abuse program under subpart II of part B of title
XIX of the Public Health Service Act (42 U.S.C. 300x-21 et
seq.) and Programs of Regional and National Significance.
Amounts transferred under this subsection shall remain
available until expended.
SEC. 12. GAO STUDY.
Not later than 1 year after the date of enactment of this
Act, the Comptroller General of the United States shall
conduct a study evaluating the various State laws, commercial
insurance methods, and existing research on requirements that
place limitations on opioid prescribing practices and provide
analysis on best practices to address over-prescribing of
opioids, while ensuring that individuals who need such
opioids can access them safely. Such study shall provide
recommendations, including with respect to--
(1) limiting first-time opioid prescriptions to a patient
for acute pain to a 72-hour supply;
(2) allowing patients or practitioners to request that a
prescription for a schedule II opioid be partially filled by
a pharmacist; and
(3) pain management treatment contracts between
practitioners and patients that establish informed consent
regarding the expectations, risks, long-term effects, and
benefits of the course of opioid treatment, treatment goals,
the potential for opioid misuse, abuse, or diversion, and
requirements and responsibilities of patients, such as
submitting to a urine drug screening.
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