[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5189 Introduced in House (IH)]
<DOC>
114th CONGRESS
2d Session
H. R. 5189
To address the opioid abuse crisis.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 11, 2016
Ms. Kuster introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
the Judiciary, Veterans' Affairs, Education and the Workforce, Ways and
Means, Armed Services, and Natural Resources, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To address the opioid abuse crisis.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Opioid Abuse
Crisis Act of 2016''.
(b) Table of Contents.--The table of contents is as follows:
Sec. 1. Short title; table of contents.
TITLE I--PUBLIC HEALTH PROVISIONS
Sec. 101. Funding for opioid and heroin abuse prevention and treatment.
Sec. 102. Opioid overdose reversal drugs prescribing grant program.
Sec. 103. Partial fills of schedule II controlled substances.
Sec. 104. Opioid use disorder treatment modernization.
Sec. 105. Nurturing and supporting healthy babies.
Sec. 106. Improving treatment for pregnant and postpartum women.
Sec. 107. Assisting veterans with military emergency medical training
to meet requirements for becoming civilian
emergency medical technicians.
Sec. 108. Information materials and resources to prevent addiction
related to youth sports injuries.
Sec. 109. Lali's Law.
Sec. 110. Opioid review modernization.
Sec. 111. Study on treatment infrastructure.
Sec. 112. National youth recovery initiative.
Sec. 113. Building communities of recovery.
TITLE II--COMPREHENSIVE OPIOID ABUSE REDUCTION
Sec. 201. Comprehensive opioid abuse grant program.
Sec. 202. Audit and accountability of grantees.
Sec. 203. Veterans treatment courts.
Sec. 204. Emergency Federal law enforcement assistance.
Sec. 205. Opioid Program Evaluation Act.
Sec. 206. Good Samaritan Assessment Act.
TITLE III--PROMOTING RESPONSIBLE OPIOID MANAGEMENT AND INCORPORATING
SCIENTIFIC EXPERTISE
Sec. 301. Short title.
Subtitle A--Opioid Therapy and Pain Management
Sec. 311. Guidelines on management of opioid therapy by Department of
Veterans Affairs and Department of Defense
and implementation of such guidelines by
Department of Veterans Affairs.
Sec. 312. Improvement of opioid safety measures by Department of
Veterans Affairs.
Sec. 313. Strengthening of joint working group on pain management of
the Department of Veterans Affairs and the
Department of Defense.
Sec. 314. Review, investigation, and report on use of opioids in
treatment by Department of Veterans
Affairs.
Subtitle B--Patient Advocacy
Sec. 321. Community meetings on improving care furnished by Department
of Veterans Affairs.
Sec. 322. Improvement of awareness of patient advocacy program and
patient bill of rights of Department of
Veterans Affairs.
Sec. 323. Comptroller general report on patient advocacy program of
Department of Veterans Affairs.
Subtitle C--Complementary and Integrative Health
Sec. 331. Expansion of research and education on and delivery of
complementary and integrative health to
veterans.
Sec. 332. Pilot program on integration of complementary alternative
medicines and related issues for veterans
and family members of veterans.
Subtitle D--Fitness of Health Care Providers
Sec. 341. Additional requirements for hiring of health care providers
by Department of Veterans Affairs.
Sec. 342. Provision of information on health care providers of
Department of Veterans Affairs to State
Medical Boards.
Sec. 343. Report on compliance by Department of Veterans Affairs with
reviews of health care providers leaving
the Department or transferring to other
facilities.
Subtitle E--Other Veterans Matters
Sec. 351. Audit of Veterans Health Administration programs of
Department of Veterans Affairs.
TITLE IV--IMPROVING SAFE CARE FOR PREVENTING INFANT ABUSE AND NEGLECT
Sec. 401. Short title.
Sec. 402. Best practices for development of plans of safe care.
Sec. 403. State plans.
Sec. 404. Data reports.
Sec. 405. Monitoring and oversight.
Sec. 406. Rule of construction.
TITLE V--OTHER PROVISIONS
Sec. 501. Programs to prevent prescription drug abuse under Medicare
parts C and D.
Sec. 502. Exclusion of authorized generic drugs from calculation of
average manufacturer price for brand name
drugs.
TITLE I--PUBLIC HEALTH PROVISIONS
SEC. 101. FUNDING FOR OPIOID AND HEROIN ABUSE PREVENTION AND TREATMENT.
(a) Funding.--There are authorized to be appropriated, and are
appropriated, out of monies in the Treasury not otherwise obligated,
$600,000,000 for fiscal year 2017, to improve opioid prescribing
practices and expand access to substance use treatments to reduce
opioid use disorders and overdose, to be made available in accordance
with this Act.
(b) State Targeted Response Cooperative Agreements.--Subpart 1 of
part B of title V of the Public Health Service Act (42 U.S.C. 290bb et
seq.) is amended by inserting after section 509 the following:
``SEC. 510. STATE TARGETED RESPONSE COOPERATIVE AGREEMENTS.
``(a) In General.--The Secretary shall enter into additional
targeted response cooperative agreements with States under this title
to expand opioid treatment capacity and make services more affordable
to those who cannot afford such services.
``(b) Awarding of Funding.--The Secretary shall allocate funding to
States under this section based on--
``(1) the severity of the opioid epidemic in the State; and
``(2) the strength of the strategy of the State to respond
to such epidemic.
``(c) Use of Funds.--Amounts received by a State under this section
shall be used to expand treatment capacity and make services more
affordable to those who cannot afford such services and to help
individuals seek treatment, successfully complete treatment, and
sustain recovery.
``(d) Funding.--Of the amounts appropriated under section 101(a) of
the Opioid Use Disorder Treatment Expansion and Modernization Act for
fiscal year 2017, $460,000,000 shall be made available to carry out
this section, to remain available until expended.''.
(c) Treatment for Prescription Drug Abuse and Heroin Use.--Section
331(b) of the Public Health Service Act (42 U.S.C. 254d(b)) is amended
by adding at the end the following:
``(3)(A) The Secretary shall use amounts made available
under subparagraph (B) to support enhanced loan repayment
awards to increase the number of clinicians in the Corps with
medication assisted treatment training to treat individuals
with opioid use disorders through loan repayments to
clinicians.
``(B) Of the amounts appropriated under section 101(a) of
the Opioid Use Disorder Treatment Expansion and Modernization
Act for fiscal year 2017, $25,000,000 shall be made available
to carry out this section, to remain available until
expended.''.
(d) Evaluation of Medication-Assisted Treatment.--Subpart 1 of part
B of title V of the Public Health Service Act (42 U.S.C. 290bb et seq.)
is amended by inserting after section 510, as added by subsection (b),
the following:
``SEC. 511. EVALUATION OF MEDICATION-ASSISTED TREATMENT.
``(a) In General.--In order to assess the treatment outcomes of
patients with opioid addiction receiving medication-assisted treatment,
the Secretary shall evaluate the short, medium, and long-term outcomes
of such substance abuse treatment programs in order to increase
effectiveness in reducing opioid use disorders, overdose, and death.
``(b) Funding.--Of the amounts appropriated under section 101(a) of
the Opioid Use Disorder Treatment Expansion and Modernization Act for
fiscal year 2017, $15,000,000 shall be made available to carry out this
section, to remain available until expended.''.
SEC. 102. OPIOID OVERDOSE REVERSAL DRUGS PRESCRIBING GRANT PROGRAM.
(a) Establishment.--
(1) In general.--Not later than six months after the date
of the enactment of this Act, the Secretary of Health and Human
Services may establish, in accordance with this section, a
five-year opioid overdose reversal drugs prescribing grant
program (in this section referred to as the ``grant program'').
(2) Maximum grant amount.--A grant made under this section
may not be for more than $200,000 per grant year.
(3) Eligible entity.--For purposes of this section, the
term ``eligible entity'' means a federally qualified health
center (as defined in section 1861(aa) of the Social Security
Act (42 U.S.C. 1395x(aa))), an opioid treatment program under
part 8 of title 42, Code of Federal Regulations, any
practitioner dispensing narcotic drugs pursuant to section
303(g) of the Controlled Substances Act (21 U.S.C. 823(g)), or
any other entity that the Secretary deems appropriate.
(4) Prescribing.--For purposes of this section, the term
``prescribing'' means, with respect to an opioid overdose
reversal drug, such as naloxone, the practice of prescribing
such drug--
(A) in conjunction with an opioid prescription for
patients at an elevated risk of overdose;
(B) in conjunction with an opioid agonist approved
under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) for the treatment of
opioid abuse disorder;
(C) to the caregiver or a close relative of
patients at an elevated risk of overdose from opioids;
or
(D) in other circumstances, as identified by the
Secretary, in which a provider identifies a patient is
at an elevated risk for an intentional or unintentional
drug overdose from heroin or prescription opioid
therapies.
(b) Application.--To be eligible to receive a grant under this
section, an eligible entity shall submit to the Secretary of Health and
Human Services, in such form and manner as specified by the Secretary,
an application that describes--
(1) the extent to which the area to which the entity will
furnish services through use of the grant is experiencing
significant morbidity and mortality caused by opioid abuse;
(2) the criteria that will be used to identify eligible
patients to participate in such program; and
(3) how such program will work to try to identify State,
local, or private funding to continue the program after
expiration of the grant.
(c) Use of Funds.--An eligible entity receiving a grant under this
section may use the grant for any of the following activities, but may
use not more than 20 percent of the grant funds for activities
described in paragraphs (4) and (5):
(1) To establish a program for prescribing opioid overdose
reversal drugs, such as naloxone.
(2) To train and provide resources for health care
providers and pharmacists on the prescribing of opioid overdose
reversal drugs, such as naloxone.
(3) To establish mechanisms and processes for tracking
patients participating in the program described in paragraph
(1) and the health outcomes of such patients.
(4) To purchase opioid overdose reversal drugs, such as
naloxone, for distribution under the program described in
paragraph (1).
(5) To offset the co-pays and other cost sharing associated
with opioid overdose reversal drugs, such as naloxone, to
ensure that cost is not a limiting factor for eligible
patients.
(6) To conduct community outreach, in conjunction with
community-based organizations, designed to raise awareness of
prescribing practices, and the availability of opioid overdose
reversal drugs, such as naloxone.
(7) To establish protocols to connect patients who have
experienced a drug overdose with appropriate treatment,
including medication assisted treatment and appropriate
counseling and behavioral therapies.
(d) Evaluations by Recipients.--As a condition of receipt of a
grant under this section, an eligible entity shall, for each year for
which the grant is received, submit to the Secretary of Health and
Human Services information on appropriate outcome measures specified by
the Secretary to assess the outcomes of the program funded by the
grant, including--
(1) the number of prescribers trained;
(2) the number of prescribers who have co-prescribed an
opioid overdose reversal drug, such as naloxone, to at least
one patient;
(3) the total number of prescriptions written for opioid
overdose reversal drugs, such as naloxone;
(4) the percentage of patients at elevated risk who
received a prescription for an opioid overdose reversal drug,
such as naloxone;
(5) the number of patients reporting use of an opioid
overdose reversal drug, such as naloxone; and
(6) any other outcome measures that the Secretary deems
appropriate.
(e) Reports by Secretary.--For each year of the grant program under
this section, the Secretary of Health and Human Services shall submit
to the appropriate committees of the House of Representatives and the
Senate a report aggregating the information received from the grant
recipients for such year under subsection (d) and evaluating the
outcomes achieved by the programs funded by grants made under this
section.
(f) Providing Information to Prescribers in Certain Federal Health
Care and Medical Facilities on Best Practices for Prescribing Opioid
Overdose Reversal Drugs.--
(1) In general.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human
Services (in this subsection referred to as the ``Secretary'')
may, as appropriate, provide information to prescribers within
Federally qualified health centers (as defined in paragraph (4)
of section 1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa))), and the health care facilities of the Indian
Health Service, on best practices for prescribing opioid
overdose reversal drugs, such as naloxone, for patients
receiving chronic opioid therapy, patients being treated for
opioid use disorders, and other patients that a provider
identifies as having an elevated risk of overdose from heroin
or prescription opioid therapies.
(2) Not establishing a medical standard of care.--The
information on best practices provided under this section shall
not be construed as constituting or establishing a medical
standard of care for prescribing opioid overdose reversal
drugs, such as naloxone, for patients described in paragraph
(1).
(3) No authorization of any additional appropriations.--The
Secretary shall carry out this subsection through funds
otherwise appropriated and nothing in this subsection shall be
construed as authorizing the appropriations of additional funds
to carry out this subsection.
(4) Elevated risk of overdose defined.--In this subsection,
the term ``elevated risk of overdose'' has the meaning given
such term by the Secretary, which--
(A) may be based on the criteria provided in the
Opioid Overdose Toolkit published by the Substance
Abuse and Mental Health Services Administration
(SAMHSA); and
(B) may include patients on a first course opioid
treatment, patients using extended-release and long-
acting opioid analgesics, and patients with a
respiratory disease or other co-morbidities.
(g) Funding.--There is authorized to be appropriated $5,000,000 to
carry out this section (other than subsection (f)) for the period of
fiscal years 2017 through 2021, of which $5,000,000 shall be made
available from amounts appropriated under section 101(a) of the Opioid
Use Disorder Treatment Expansion and Modernization Act for fiscal year
2017, to remain available until expended.
SEC. 103. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES.
(a) In General.--Section 309 of the Controlled Substances Act (21
U.S.C. 829) is amended by adding at the end the following:
``(f) Partial Fills of Schedule II Controlled Substances.--
``(1) Partial fills.--
``(A) In general.--A prescription for a controlled
substance in schedule II may be partially filled if--
``(i) it is not prohibited by State law;
``(ii) the prescription is written and
filled in accordance with this Act, regulations
prescribed by the Attorney General, and State
law;
``(iii) the partial fill is requested by
the patient or the practitioner that wrote the
prescription; and
``(iv) the total quantity dispensed in all
partial fillings does not exceed the total
quantity prescribed.
``(B) Other circumstances.--A prescription for a
controlled substance in schedule II may be partially
filled in accordance with section 1306.13 of title 21,
Code of Federal Regulations (as in effect on the date
of enactment of the Opioid Abuse Crisis Act of 2016).
``(2) Remaining portions.--
``(A) In general.--Except as provided in
subparagraph (B), remaining portions of a partially
filled prescription for a controlled substance in
schedule II--
``(i) may be filled; and
``(ii) shall be filled not later than 30
days after the date on which the prescription
is written.
``(B) Emergency situations.--In emergency
situations, as described in subsection (a), the
remaining portions of a partially filled prescription
for a controlled substance in schedule II--
``(i) may be filled; and
``(ii) shall be filled not later than 72
hours after the prescription is issued.''.
(b) Rule of Construction.--Nothing in this section shall be
construed to affect the authority of the Attorney General to allow a
prescription for a controlled substance in schedule III, IV, or V of
section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to
be partially filled.
SEC. 104. OPIOID USE DISORDER TREATMENT MODERNIZATION.
(a) In General.--Section 303(g)(2) of the Controlled Substances Act
(21 U.S.C. 823(g)(2)) is amended--
(1) in subparagraph (B), by striking clauses (i), (ii), and
(iii) and inserting the following:
``(i) The practitioner is a qualifying practitioner (as
defined in subparagraph (G)).
``(ii) With respect to patients to whom the practitioner
will provide such drugs or combinations of drugs, the
practitioner has the capacity to provide directly, by referral,
or in such other manner as determined by the Secretary--
``(I) all schedule III, IV, and V drugs, as well as
unscheduled medications approved by the Food and Drug
Administration, for the treatment of opioid use
disorder, including such drugs and medications for
maintenance, detoxification, overdose reversal, and
relapse prevention, as available; and
``(II) appropriate counseling and other appropriate
ancillary services.
``(iii)(I) The total number of such patients of the
practitioner at any one time will not exceed the applicable
number. Except as provided in subclauses (II) and (III), the
applicable number is 30.
``(II) The applicable number is 100 if, not sooner than 1
year after the date on which the practitioner submitted the
initial notification, the practitioner submits a second
notification to the Secretary of the need and intent of the
practitioner to treat up to 100 patients.
``(III) The applicable number is 300 if the practitioner is
a qualifying physician meeting the requirement of subclause
(VI) and, not sooner than 1 year after the date on which the
physician submitted a second notification under subclause (II),
the practitioner submits a third notification to the Secretary
of the need and intent of the physician to treat up to 300
patients.
``(IV) The Secretary may by regulation change such total
number.
``(V) The Secretary may exclude from the applicable number
patients to whom such drugs or combinations of drugs are
directly administered by the qualifying practitioner in the
office setting.
``(VI) For purposes of subclause (III), a qualifying
physician meets the requirement of this subclause if the
physician--
``(aa) holds a special certification in addiction
psychiatry or addiction medicine as described in clause
(ii) from the American Board of Medical Specialties,
the American Board of Addiction Medicine, the American
Osteopathic Association, the American Society of
Addiction Medicine, or such other organization as the
Secretary determines to be appropriate for purposes of
this subclause; or
``(bb) has completed not fewer than 24 hours of
training, with respect to the treatment and management
of opiate-dependent patients, addressing the topics
listed in subparagraph (G)(ii)(IV).
The Secretary may review and update the requirements of this
subclause.
``(iv) In the case of a third notification under clause
(iii)(III), the qualifying physician maintains and implements a
diversion control plan that contains specific measures to
reduce the likelihood of the diversion of controlled substances
prescribed by the physician for the treatment of opioid use
disorder.
``(v) In the case of a third notification under clause
(iii)(III), the qualifying physician obtains a written
agreement from each patient, including the patient's signature,
that the patient--
``(I) will receive an initial assessment and
treatment plan and periodic assessments and treatment
plans thereafter;
``(II) will be subject to medication adherence and
substance use monitoring;
``(III) understands available treatment options,
including all drugs approved by the Food and Drug
Administration for the treatment of opioid use
disorder, including their potential risks and benefits;
and
``(IV) understands that receiving regular
counseling services is critical to recovery.
``(vi) The practitioner will comply with the reporting
requirements of subparagraph (D)(i)(IV).'';
(2) in subparagraph (D)--
(A) in clause (i), by adding at the end the
following:
``(IV) The practitioner reports to the Secretary, at such
times and in such manner as specified by the Secretary, such
information and assurances as the Secretary determines
necessary to assess whether the practitioner continues to meet
the requirements for a waiver under this paragraph.'';
(B) in clause (ii), by striking ``Upon receiving a
notification under subparagraph (B)'' and inserting
``Upon receiving a determination from the Secretary
under clause (iii) finding that a practitioner meets
all requirements for a waiver under subparagraph (B)'';
and
(C) in clause (iii)--
(i) by inserting ``and shall forward such
determination to the Attorney General'' before
the period at the end of the first sentence;
and
(ii) by striking ``physician'' and
inserting ``practitioner'';
(3) in subparagraph (G)--
(A) by amending clause (ii)(IV) to read as follows:
``(IV) The physician has, with respect to the
treatment and management of opiate-dependent patients,
completed not less than eight hours of training
(through classroom situations, seminars at professional
society meetings, electronic communications, or
otherwise) that is provided by the American Society of
Addiction Medicine, the American Academy of Addiction
Psychiatry, the American Medical Association, the
American Osteopathic Association, the American
Psychiatric Association, or any other organization that
the Secretary determines is appropriate for purposes of
this subclause. Such training shall address--
``(aa) opioid maintenance and
detoxification;
``(bb) appropriate clinical use of all
drugs approved by the Food and Drug
Administration for the treatment of opioid use
disorder;
``(cc) initial and periodic patient
assessments (including substance use
monitoring);
``(dd) individualized treatment planning;
overdose reversal; relapse prevention;
``(ee) counseling and recovery support
services;
``(ff) staffing roles and considerations;
``(gg) diversion control; and
``(hh) other best practices, as identified
by the Secretary.''; and
(B) by adding at the end the following:
``(iii) The term `qualifying practitioner' means--
``(I) a qualifying physician, as defined in clause
(ii); or
``(II) a qualifying other practitioner, as defined
in clause (iv).
``(iv) The term `qualifying other practitioner' means a
nurse practitioner or physician assistant who satisfies each of
the following:
``(I) The nurse practitioner or physician assistant
is licensed under State law to prescribe schedule III,
IV, or V medications for the treatment of pain.
``(II) The nurse practitioner or physician
assistant satisfies 1 or more of the following:
``(aa) Has completed not fewer than 24
hours of initial training addressing each of
the topics listed in clause (ii)(IV) (through
classroom situations, seminars at professional
society meetings, electronic communications, or
otherwise) provided by the American Society of
Addiction Medicine, the American Academy of
Addiction Psychiatry, the American Medical
Association, the American Osteopathic
Association, the American Nurses Credentialing
Center, the American Psychiatric Association,
the American Association of Nurse
Practitioners, the American Academy of
Physician Assistants, or any other organization
that the Secretary determines is appropriate
for purposes of this subclause.
``(bb) Has such other training or
experience as the Secretary determines will
demonstrate the ability of the nurse
practitioner or physician assistant to treat
and manage opiate-dependent patients.
``(III) The nurse practitioner or physician
assistant is supervised by or works in collaboration
with a qualifying physician, if the nurse practitioner
or physician assistant is required by State law to
prescribe medications for the treatment of opioid use
disorder in collaboration with or under the supervision
of a physician.
The Secretary may review and update the requirements for being
a qualifying other practitioner under this clause.''; and
(4) in subparagraph (H)--
(A) in clause (i), by inserting after subclause
(II) the following:
``(III) Such other elements of the requirements under this
paragraph as the Secretary determines necessary for purposes of
implementing such requirements.''; and
(B) by amending clause (ii) to read as follows:
``(ii) Not later than one year after the date of enactment of the
Opioid Use Disorder Treatment Expansion and Modernization Act, the
Secretary shall update the treatment improvement protocol containing
best practice guidelines for the treatment of opioid-dependent patients
in office-based settings. The Secretary shall update such protocol in
consultation with experts in opioid use disorder research and
treatment.''.
(b) Recommendation of Revocation or Suspension of Registration in
Case of Substantial Noncompliance.--The Secretary of Health and Human
Services may recommend to the Attorney General that the registration of
a practitioner be revoked or suspended if the Secretary determines,
according to such criteria as the Secretary establishes by regulation,
that a practitioner who is registered under section 303(g)(2) of the
Controlled Substances Act (21 U.S.C. 823(g)(2)) is not in substantial
compliance with the requirements of such section, as amended by this
Act.
(c) Opioid Defined.--Section 102(18) of the Controlled Substances
Act (21 U.S.C. 802(18)) is amended by inserting ``or `opioid''' after
``The term `opiate'''.
(d) Reports to Congress.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act and not less than over every 5 years
thereafter, the Secretary of Health and Human Services, in
consultation with the Drug Enforcement Administration and
experts in opioid use disorder research and treatment, shall--
(A) perform a thorough review of the provision of
opioid use disorder treatment services in the United
States, including services provided in opioid treatment
programs and other specialty and nonspecialty settings;
and
(B) submit a report to the Congress on the findings
and conclusions of such review.
(2) Contents.--Each report under paragraph (1) shall
include an assessment of--
(A) compliance with the requirements of section
303(g)(2) of the Controlled Substances Act (21 U.S.C.
823(g)(2)), as amended by this Act;
(B) the measures taken by the Secretary of Health
and Human Services to ensure such compliance;
(C) whether there is further need to increase or
decrease the number of patients a waivered practitioner
is permitted to treat, as provided for by the amendment
made by subsection (a)(1);
(D) the extent to which, and proportions with
which, the full range of Food and Drug Administration-
approved treatments for opioid use disorder are used in
routine health care settings and specialty substance
use disorder treatment settings;
(E) access to, and use of, counseling and recovery
support services, including the percentage of patients
receiving such services;
(F) changes in State or local policies and
legislation relating to opioid use disorder treatment;
(G) the use of prescription drug monitoring
programs by practitioners who are permitted to dispense
narcotic drugs to individuals pursuant to a waiver
under section 303(g)(2) of the Controlled Substances
Act (21 U.S.C. 823(g)(2));
(H) the findings resulting from inspections by the
Drug Enforcement Administration of practitioners
described in subparagraph (G); and
(I) the effectiveness of cross-agency collaboration
between the Department of Health and Human Services and
the Drug Enforcement Administration for expanding
effective opioid use disorder treatment.
SEC. 105. NURTURING AND SUPPORTING HEALTHY BABIES.
(a) GAO Report on Neonatal Abstinence Syndrome (NAS).--
(1) In general.--Not later than one year after the date of
the enactment of this Act, the Comptroller General of the
United States shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Finance and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on neonatal abstinence syndrome
(in this section referred to as ``NAS'') in the United States.
(2) Information to be included in report.--Such report
shall include information on the following:
(A) The prevalence of NAS in the United States,
including the proportion of children born in the United
States with NAS who are eligible for medical assistance
under State Medicaid programs under title XIX of the
Social Security Act at birth and the costs associated
with NAS through such programs.
(B) The services for which coverage is available
under State Medicaid programs for treatment of infants
with NAS.
(C) The settings (including inpatient, outpatient,
hospital-based, and other settings) for the treatment
of infants with NAS and the reimbursement methodologies
and costs associated with such treatment in such
settings.
(D) The prevalence of utilization of various care
settings under State Medicaid programs for treatment of
infants with NAS and any Federal barriers to treating
such infants under such programs, particularly in non-
hospital-based settings.
(3) Recommendations.--Such report also shall include such
recommendations as the Comptroller General determines
appropriate for improvements that will ensure access to
treatment for infants with NAS under State Medicaid programs.
(b) Excluding Abuse-Deterrent Formulations of Prescription Drugs
From the Medicaid Additional Rebate Requirement for New Formulations of
Prescription Drugs.--
(1) In general.--The last sentence of section 1927(c)(2)(C)
of the Social Security Act (42 U.S.C. 1396r-8(c)(2)(C)) is
amended by inserting before the period at the end the
following: ``, but does not include an abuse-deterrent
formulation of the drug (as determined by the Secretary),
regardless of whether such abuse-deterrent formulation is an
extended release formulation''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to drugs that are paid for by a State in calendar
quarters beginning on or after the date of the enactment of
this Act.
(c) Limiting Disclosure of Predictive Modeling and Other Analytics
Technologies To Identify and Prevent Waste, Fraud, and Abuse.--
(1) In general.--Title XI of the Social Security Act is
amended by inserting after section 1128J (42 U.S.C. 1320a-7k)
the following new section:
``SEC. 1128K. DISCLOSURE OF PREDICTIVE MODELING AND OTHER ANALYTICS
TECHNOLOGIES TO IDENTIFY AND PREVENT WASTE, FRAUD, AND
ABUSE.
``(a) Reference to Predictive Modeling Technologies Requirements.--
For provisions relating to the use of predictive modeling and other
analytics technologies to identify and prevent waste, fraud, and abuse
with respect to the Medicare program under title XVIII, the Medicaid
program under title XIX, and the Children's Health Insurance Program
under title XXI, see section 4241 of the Small Business Jobs Act of
2010 (42 U.S.C. 1320a-7m).
``(b) Limiting Disclosure of Predictive Modeling Technologies.--In
implementing such provisions under such section 4241 with respect to
covered algorithms (as defined in subsection (c)), the following shall
apply:
``(1) Nonapplication of foia.--The covered algorithms used
or developed for purposes of such section (including by the
Secretary or a State (or an entity operating under a contract
with a State)) shall be exempt from disclosure under section
552(b)(3) of title 5, United States Code.
``(2) Limitation with respect to use and disclosure of
information by state agencies.--
``(A) In general.--A State agency may not use or
disclose covered algorithms used or developed for
purposes of such section except for purposes of
administering the State plan (or a waiver of the plan)
under the Medicaid program under title XIX or the State
child health plan (or a waiver of the plan) under the
Children's Health Insurance Program under title XXI,
including by enabling an entity operating under a
contract with a State to assist the State to identify
or prevent waste, fraud and abuse with respect to such
programs.
``(B) Information security.--A State agency shall
have in effect data security and control policies that
the Secretary finds adequate to ensure the security of
covered algorithms used or developed for purposes of
such section 4241 and to ensure that access to such
information is restricted to authorized persons for
purposes of authorized uses and disclosures described
in subparagraph (A).
``(C) Procedural requirements.--State agencies to
which information is disclosed pursuant to such section
4241 shall adhere to uniform procedures established by
the Secretary.
``(c) Covered Algorithm Defined.--In this section, the term
`covered algorithm'--
``(1) means a predictive modeling or other analytics
technology, as used for purposes of section 4241(a) of the
Small Business Jobs Act of 2010 (42 U.S.C. 1320a-7m(a)) to
identify and prevent waste, fraud, and abuse with respect to
the Medicare program under title XVIII, the Medicaid program
under title XIX, and the Children's Health Insurance Program
under title XXI; and
``(2) includes the mathematical expressions utilized in the
application of such technology and the means by which such
technology is developed.''.
(2) Conforming amendments.--
(A) Medicaid state plan requirement.--Section
1902(a) of the Social Security Act (42 U.S.C. 1396a(a))
is amended--
(i) in paragraph (80), by striking ``and''
at the end;
(ii) in paragraph (81), by striking the
period at the end and inserting ``; and''; and
(iii) by inserting after paragraph (81) the
following new paragraph:
``(82) provide that the State agency responsible for
administering the State plan under this title provides
assurances to the Secretary that the State agency is in
compliance with subparagraphs (A), (B), and (C) of section
1128K(b)(2).''.
(B) State child health plan requirement.--Section
2102(a)(7) of the Social Security Act (42 U.S.C.
1397bb(a)(7)) is amended--
(i) in subparagraph (A), by striking ``,
and'' at the end and inserting a semicolon;
(ii) in subparagraph (B), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following
new subparagraph:
``(C) to ensure that the State agency involved is
in compliance with subparagraphs (A), (B), and (C) of
section 1128K(b)(2).''.
(d) Medicaid Improvement Fund.--Section 1941(b)(1) of the Social
Security Act (42 U.S.C. 1396w-1(b)(1)) is amended to read as follows:
``(1) In general.--There shall be available to the Fund,
for expenditures from the Fund for fiscal year 2021 and
thereafter, $5,000,000.''.
SEC. 106. IMPROVING TREATMENT FOR PREGNANT AND POSTPARTUM WOMEN.
(a) Reauthorization of Residential Treatment Programs for Pregnant
and Postpartum Women.--Section 508 of the Public Health Service Act (42
U.S.C. 290bb-1) is amended--
(1) in subsection (p), in the first sentence, by inserting
``(other than subsection (r))'' after ``section''; and
(2) in subsection (r), by striking ``such sums'' and all
that follows through ``2003'' and inserting ``$16,900,000 for
each of fiscal years 2017 through 2021''.
(b) Pilot Program Grants for State Substance Abuse Agencies.--
(1) In general.--Section 508 of the Public Health Service
Act (42 U.S.C. 290bb-1) is amended--
(A) by redesignating subsection (r), as amended by
subsection (a), as subsection (s); and
(B) by inserting after subsection (q) the following
new subsection:
``(r) Pilot Program for State Substance Abuse Agencies.--
``(1) In general.--From amounts made available under
subsection (s), the Director of the Center for Substance Abuse
Treatment shall carry out a pilot program under which
competitive grants are made by the Director to State substance
abuse agencies to--
``(A) enhance flexibility in the use of funds
designed to support family-based services for pregnant
and postpartum women with a primary diagnosis of a
substance use disorder, including opioid use disorders;
``(B) help State substance abuse agencies address
identified gaps in services furnished to such women
along the continuum of care, including services
provided to women in nonresidential based settings; and
``(C) promote a coordinated, effective, and
efficient State system managed by State substance abuse
agencies by encouraging new approaches and models of
service delivery.
``(2) Requirements.--In carrying out the pilot program
under this subsection, the Director shall--
``(A) require State substance abuse agencies to
submit to the Director applications, in such form and
manner and containing such information as specified by
the Director, to be eligible to receive a grant under
the program;
``(B) identify, based on such submitted
applications, State substance abuse agencies that are
eligible for such grants;
``(C) require services proposed to be furnished
through such a grant to support family-based treatment
and other services for pregnant and postpartum women
with a primary diagnosis of a substance use disorder,
including opioid use disorders;
``(D) not require that services furnished through
such a grant be provided solely to women that reside in
facilities;
``(E) not require that grant recipients under the
program make available through use of the grant all
services described in subsection (d); and
``(F) consider not applying requirements described
in paragraphs (1) and (2) of subsection (f) to
applicants, depending on the circumstances of the
applicant.
``(3) Required services.--
``(A) In general.--The Director shall specify a
minimum set of services required to be made available
to eligible women through a grant awarded under the
pilot program under this subsection. Such minimum set--
``(i) shall include requirements described
in subsection (c) and be based on the
recommendations submitted under subparagraph
(B); and
``(ii) may be selected from among the
services described in subsection (d) and
include other services as appropriate.
``(B) Stakeholder input.--The Director shall
convene and solicit recommendations from stakeholders,
including State substance abuse agencies, health care
providers, persons in recovery from substance abuse,
and other appropriate individuals, for the minimum set
of services described in subparagraph (A).
``(4) Duration.--The pilot program under this subsection
shall not exceed 5 years.
``(5) Evaluation and report to congress.--The Director of
the Center for Behavioral Health Statistics and Quality shall
fund an evaluation of the pilot program at the conclusion of
the first grant cycle funded by the pilot program. The Director
of the Center for Behavioral Health Statistics and Quality, in
coordination with the Director of the Center for Substance
Abuse Treatment shall submit to the relevant committees of
jurisdiction of the House of Representatives and the Senate a
report on such evaluation. The report shall include at a
minimum outcomes information from the pilot program, including
any resulting reductions in the use of alcohol and other drugs;
engagement in treatment services; retention in the appropriate
level and duration of services; increased access to the use of
medications approved by the Food and Drug Administration for
the treatment of substance use disorders in combination with
counseling; and other appropriate measures.
``(6) State substance abuse agencies defined.--For purposes
of this subsection, the term `State substance abuse agency'
means, with respect to a State, the agency in such State that
manages the Substance Abuse Prevention and Treatment Block
Grant under part B of title XIX.''.
(2) Funding.--Subsection (s) of section 508 of the Public
Health Service Act (42 U.S.C. 290bb-1), as amended by
subsection (a) and redesignated by paragraph (1), is further
amended by adding at the end the following new sentence: ``Of
the amounts made available for a year pursuant to the previous
sentence to carry out this section, not more than 25 percent of
such amounts shall be made available for such year to carry out
subsection (r), other than paragraph (5) of such subsection.
Notwithstanding the preceding sentence, no funds shall be made
available to carry out subsection (r) for a fiscal year unless
the amount made available to carry out this section for such
fiscal year is more than the amount made available to carry out
this section for fiscal year 2016.''.
(c) Cut-Go Compliance.--Subsection (f) of section 319D of the
Public Health Service Act (42 U.S.C. 247d-4) is amended by striking
``through 2018'' and inserting ``through 2016, $133,300,000 for fiscal
year 2017, and $138,300,000 for fiscal year 2018''.
SEC. 107. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL TRAINING
TO MEET REQUIREMENTS FOR BECOMING CIVILIAN EMERGENCY
MEDICAL TECHNICIANS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 314 the following:
``SEC. 315. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL TRAINING
TO MEET REQUIREMENTS FOR BECOMING CIVILIAN EMERGENCY
MEDICAL TECHNICIANS.
``(a) Program.--The Secretary shall establish a program consisting
of awarding demonstration grants to States to streamline State
requirements and procedures in order to assist veterans who completed
military emergency medical technician training while serving in the
Armed Forces of the United States to meet certification, licensure, and
other requirements applicable to becoming an emergency medical
technician in the State.
``(b) Use of Funds.--Amounts received as a demonstration grant
under this section shall be used to prepare and implement a plan to
streamline State requirements and procedures as described in subsection
(a), including by--
``(1) determining the extent to which the requirements for
the education, training, and skill level of emergency medical
technicians in the State are equivalent to requirements for the
education, training, and skill level of military emergency
medical technicians; and
``(2) identifying methods, such as waivers, for military
emergency medical technicians to forgo or meet any such
equivalent State requirements.
``(c) Eligibility.--To be eligible for a grant under this section,
a State shall demonstrate that the State has a shortage of emergency
medical technicians.
``(d) Report.--The Secretary shall submit to the Congress an annual
report on the program under this section.
``(e) Funding.--No additional funds are authorized to be
appropriated for the purpose of carrying out this section. This section
shall be carried out using amounts otherwise available for such
purpose.''.
SEC. 108. INFORMATION MATERIALS AND RESOURCES TO PREVENT ADDICTION
RELATED TO YOUTH SPORTS INJURIES.
(a) Technical Clarification.--Effective as if included in the
enactment of the Children's Health Act of 2000 (Public Law 106-310),
section 3405(a) of such Act (114 Stat. 1221) is amended by striking
``Part E of title III'' and inserting ``Part E of title III of the
Public Health Service Act''.
(b) Amendment.--Title III of the Public Health Service Act is
amended by inserting after part D of such title (42 U.S.C. 254b et
seq.) the following new part E:
``PART E--OPIOID USE DISORDER
``SEC. 341. INFORMATION MATERIALS AND RESOURCES TO PREVENT ADDICTION
RELATED TO YOUTH SPORTS INJURIES.
``(a) Report.--The Secretary shall--
``(1) not later than 24 months after the date of the
enactment of this section, make publicly available a report
determining the extent to which informational materials and
resources described in subsection (b) are available to
teenagers and adolescents who play youth sports, families of
such teenagers and adolescents, nurses, youth sports groups,
and relevant health care provider groups; and
``(2) for purposes of educating and preventing addiction in
teenagers and adolescents who are injured playing youth sports
and are subsequently prescribed an opioid, not later than 12
months after such report is made publicly available and taking
into consideration the findings of such report, develop and, in
coordination with youth sports groups, disseminate
informational materials and resources described in subsection
(b) for teenagers and adolescents who play youth sports,
families of such teenagers and adolescents, nurses, youth
sports groups, and relevant health care provider groups.
``(b) Materials and Resources Described.--For purposes of this
section, the informational materials and resources described in this
subsection are informational materials and resources with respect to
youth sports injuries for which opioids are potentially prescribed and
subsequently potentially lead to addiction, including materials and
resources focused on the dangers of opioid use and misuse, treatment
options for such injuries that do not involve the use of opioids, and
how to seek treatment for addiction.
``(c) No Additional Funds.--No additional funds are authorized to
be appropriated for the purpose of carrying out this section. This
section shall be carried out using amounts otherwise available for such
purpose.''.
SEC. 109. LALI'S LAW.
(a) Opioid Overdose Reversal Medication Access and Education Grant
Program.--Part E of title III of the Public Health Service Act, as
added by section 109, is amended by adding at the end the following
``SEC. 342. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION
GRANT PROGRAMS.
``(a) Grants to States.--The Secretary may make grants to States
for--
``(1) developing standing orders for pharmacies regarding
opioid overdose reversal medication;
``(2) encouraging pharmacies to dispense opioid overdose
reversal medication pursuant to a standing order;
``(3) implementing best practices for persons authorized to
prescribe medication regarding--
``(A) prescribing opioids for the treatment of
chronic pain;
``(B) co-prescribing opioid overdose reversal
medication with opioids; and
``(C) discussing the purpose and administration of
opioid overdose reversal medication with patients;
``(4) developing or adapting training materials and methods
for persons authorized to prescribe or dispense medication to
use in educating the public regarding--
``(A) when and how to administer opioid overdose
reversal medication; and
``(B) steps to be taken after administering opioid
overdose reversal medication; and
``(5) educating the public regarding--
``(A) the public health benefits of opioid overdose
reversal medication; and
``(B) the availability of opioid overdose reversal
medication without a person-specific prescription.
``(b) Certain Requirement.--A grant may be made under this section
only if the State involved has authorized standing orders regarding
opioid overdose reversal medication.
``(c) Preference in Making Grants.--In making grants under this
section, the Secretary shall give preference to States that--
``(1) have not issued standing orders regarding opioid
overdose reversal medication;
``(2) authorize standing orders that permit community-based
organizations, substance abuse programs, or other nonprofit
entities to acquire, dispense, or administer opioid overdose
reversal medication;
``(3) authorize standing orders that permit police, fire,
or emergency medical services agencies to acquire and
administer opioid overdose reversal medication;
``(4) have a higher per capita rate of opioid overdoses
than other applicant States; or
``(5) meet any other criteria deemed appropriate by the
Secretary.
``(d) Grant Terms.--
``(1) Number.--A State may not receive more than 1 grant
under this section.
``(2) Period.--A grant under this section shall be for a
period of 3 years.
``(3) Amount.--A grant under this section may not exceed
$500,000.
``(4) Limitation.--A State may use not more than 20 percent
of a grant under this section for educating the public pursuant
to subsection (a)(5).
``(e) Applications.--To be eligible to receive a grant under this
section, a State shall submit an application to the Secretary in such
form and manner and containing such information as the Secretary may
require, including detailed proposed expenditures of grant funds.
``(f) Reporting.--Not later than 3 months after the Secretary
disburses the first grant payment to any State under this section and
every 6 months thereafter for 3 years, such State shall submit a report
to the Secretary that includes the following:
``(1) The name and ZIP Code of each pharmacy in the State
that dispenses opioid overdose reversal medication under a
standing order.
``(2) The total number of opioid overdose reversal
medication doses dispensed by each such pharmacy, specifying
how many were dispensed with or without a person-specific
prescription.
``(3) The number of pharmacists in the State who have
participated in training pursuant to subsection (a)(4).
``(g) Definitions.--In this section:
``(1) Opioid overdose reversal medication.--The term
`opioid overdose reversal medication' means any drug, including
naloxone, that--
``(A) blocks opioids from attaching to, but does
not itself activate, opioid receptors; or
``(B) inhibits the effects of opioids on opioid
receptors.
``(2) Standing order.--The term `standing order' means a
document prepared by a person authorized to prescribe
medication that permits another person to acquire, dispense, or
administer medication without a person-specific prescription.
``(h) Authorization of Appropriations.--
``(1) In general.--To carry out this section, there is
authorized to be appropriated $5,000,000 for the period of
fiscal years 2017 through 2019.
``(2) Administrative costs.--Not more than 3 percent of the
amounts made available to carry out this section may be used by
the Secretary for administrative expenses of carrying out this
section.''.
(b) Cut-Go Compliance.--Subsection (f) of section 319D of the
Public Health Service Act (42 U.S.C. 247d-4) is amended by inserting
before the period at the end the following: ``(except such dollar
amount shall be reduced by $5,000,000 for fiscal year 2017)''.
SEC. 110. OPIOID REVIEW MODERNIZATION.
(a) FDA Opioid Action Plan.--Chapter V of the Federal Food, Drug,
and Cosmetic Act is amended by inserting after section 569 of such Act
(21 U.S.C. 350bbb-8) the following:
``SEC. 569-1. OPIOID ACTION PLAN.
``(a) New Drug Application.--
``(1) In general.--Subject to paragraph (2), prior to the
approval pursuant to an application under section 505(b) of a
new drug that is an opioid and does not have abuse-deterrent
properties, the Secretary shall refer the application to an
advisory committee of the Food and Drug Administration to seek
recommendations from such advisory committee.
``(2) Public health exemption.--A referral to an advisory
committee under paragraph (1) is not required with respect to a
new drug if the Secretary--
``(A) finds that such a referral is not in the
interest of protecting and promoting public health;
``(B) finds that such a referral is not necessary
based on a review of the relevant scientific
information; and
``(C) submits a notice containing the rationale for
such findings to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives.
``(b) Pediatric Opioid Labeling.--The Secretary 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 the
Secretary approves any labeling or change to labeling for any drug that
is an opioid intended for use in a pediatric population.
``(c) Sunset.--The requirements of subsections (a) and (b) shall
cease to be effective on October 1, 2022.''.
(b) Prescriber Education.--Not later than 1 year after the date of
the 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 relevant stakeholders, shall develop
recommendations regarding education programs for prescribers of opioids
pursuant to section 505-1 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355-1), including recommendations on--
(1) which prescribers should participate in such programs;
and
(2) how often participation in such programs is necessary.
(c) Guidance on Evaluating the Abuse Deterrence of Generic Solid
Oral Opioid Drug Products.--Not later than 2 years after the end of the
period for public comment on the draft guidance entitled ``General
Principals for Evaluating the Abuse Deterrence of Generic Solid Oral
Opioid Drug Products'' issued by the Center for Drug Evaluation and
Research of the Food and Drug Administration in March 2016, the
Commissioner of Food and Drugs shall publish in the Federal Register a
final version of such guidance.
SEC. 111. STUDY ON TREATMENT INFRASTRUCTURE.
Not later than 24 months after the date of enactment of this Act,
the Comptroller General of the United States shall initiate an
evaluation, and submit to Congress a report, of the inpatient and
outpatient treatment capacity, availability, and needs of the United
States, which shall include, to the extent data are available--
(1) the capacity of acute residential or inpatient
detoxification programs;
(2) the capacity of inpatient clinical stabilization
programs, transitional residential support services, and
residential rehabilitation programs;
(3) the capacity of demographic specific residential or
inpatient treatment programs, such as those designed for
pregnant women or adolescents;
(4) geographical differences of the availability of
residential and outpatient treatment and recovery options for
substance use disorders across the continuum of care;
(5) the availability of residential and outpatient
treatment programs that offer treatment options based on
reliable scientific evidence of efficacy for the treatment of
substance use disorders, including the use of Food and Drug
Administration-approved medicines and evidence-based
nonpharmacological therapies;
(6) the number of patients in residential and specialty
outpatient treatment services for substance use disorders;
(7) an assessment of the need for residential and
outpatient treatment for substance use disorders across the
continuum of care;
(8) the availability of residential and outpatient
treatment programs to American Indians and Alaska Natives
through an Indian health program (as defined by section 4 of
the Indian Health Care Improvement Act (25 U.S.C. 1603)); and
(9) the barriers (including technological barriers) at the
Federal, State, and local levels to real-time reporting of de-
identified information on drug overdoses and ways to overcome
such barriers.
SEC. 112. NATIONAL YOUTH RECOVERY INITIATIVE.
Part II of title I of the Omnibus Crime Control and Safe Streets
Act of 1968 (42 U.S.C. 3797cc et seq.) is amended by adding at the end
the following:
``SEC. 2999A. NATIONAL YOUTH RECOVERY INITIATIVE.
``(a) Definitions.--In this section:
``(1) Eligible entity.--The term `eligible entity' means--
``(A) a high school that has been accredited as a
recovery high school by the Association of Recovery
Schools;
``(B) an accredited high school that is seeking to
establish or expand recovery support services;
``(C) an institution of higher education;
``(D) a recovery program at a nonprofit collegiate
institution; or
``(E) a nonprofit organization.
``(2) Institution of higher education.--The term
`institution of higher education' has the meaning given the
term in section 101 of the Higher Education Act of 1965 (20
U.S.C. 1001).
``(3) Recovery program.--The term `recovery program'--
``(A) means a program to help individuals who are
recovering from substance use disorders to initiate,
stabilize, and maintain healthy and productive lives in
the community; and
``(B) includes peer-to-peer support and communal
activities to build recovery skills and supportive
social networks.
``(b) Grants Authorized.--The Secretary of Health and Human
Services, in coordination with the Secretary of Education, may award
grants to eligible entities to enable the entities to--
``(1) provide substance use disorder recovery support
services to young people in high school and enrolled in
institutions of higher education;
``(2) help build communities of support for young people in
recovery through a spectrum of activities such as counseling
and health- and wellness-oriented social activities; and
``(3) encourage initiatives designed to help young people
achieve and sustain recovery from substance use disorders.
``(c) Use of Funds.--Grants awarded under subsection (b) may be
used for activities to develop, support, and maintain youth recovery
support services, including--
``(1) the development and maintenance of a dedicated
physical space for recovery programs;
``(2) dedicated staff for the provision of recovery
programs;
``(3) health- and wellness-oriented social activities and
community engagement;
``(4) establishment of recovery high schools;
``(5) coordination of recovery programs with--
``(A) substance use disorder treatment programs and
systems;
``(B) providers of mental health services;
``(C) primary care providers and physicians;
``(D) the criminal justice system, including the
juvenile justice system;
``(E) employers;
``(F) housing services;
``(G) child welfare services;
``(H) high schools and institutions of higher
education; and
``(I) other programs or services related to the
welfare of an individual in recovery from a substance
use disorder;
``(6) the development of peer-to-peer support programs or
services; and
``(7) additional activities that help youths and young
adults to achieve recovery from substance use disorders.
``(d) Funding.--There is authorized to be appropriated $5,000,000
to carry out this section for each of fiscal years 2017 through 2021,
of which $5,000,000 shall be made available from amounts appropriated
under section 101(a) of the Opioid Use Disorder Treatment Expansion and
Modernization Act for fiscal year 2017, to remain available until
expended.''.
SEC. 113. BUILDING COMMUNITIES OF RECOVERY.
Part II of title I of the Omnibus Crime Control and Safe Streets
Act of 1968 (42 U.S.C. 3797cc et seq.), as amended by section 113, is
amended by adding at the end the following:
``SEC. 2999B. BUILDING COMMUNITIES OF RECOVERY.
``(a) Definition.--In this section, the term `recovery community
organization' means an independent nonprofit organization that--
``(1) mobilizes resources within and outside of the
recovery community to increase the prevalence and quality of
long-term recovery from substance use disorders; and
``(2) is wholly or principally governed by people in
recovery for substance use disorders who reflect the community
served.
``(b) Grants Authorized.--The Secretary of Health and Human
Services may award grants to recovery community organizations to enable
such organizations to develop, expand, and enhance recovery services.
``(c) Federal Share.--The Federal share of the costs of a program
funded by a grant under this section may not exceed 50 percent.
``(d) Use of Funds.--Grants awarded under subsection (b)--
``(1) shall be used to develop, expand, and enhance
community and statewide recovery support services; and
``(2) may be used to--
``(A) advocate for individuals in recovery from
substance use disorders;
``(B) build connections between recovery networks,
between recovery community organizations, and with
other recovery support services, including--
``(i) substance use disorder treatment
programs and systems;
``(ii) providers of mental health services;
``(iii) primary care providers and
physicians;
``(iv) the criminal justice system;
``(v) employers;
``(vi) housing services;
``(vii) child welfare agencies; and
``(viii) other recovery support services
that facilitate recovery from substance use
disorders;
``(C) reduce the stigma associated with substance
use disorders;
``(D) conduct public education and outreach on
issues relating to substance use disorders and
recovery, including--
``(i) how to identify the signs of
addiction;
``(ii) the resources that are available to
individuals struggling with addiction and
families who have a family member struggling
with or being treated for addiction, including
programs that mentor and provide support
services to children;
``(iii) the resources that are available to
help support individuals in recovery; and
``(iv) information on the medical
consequences of substance use disorders,
including neonatal abstinence syndrome and
potential infection with human immunodeficiency
virus and viral hepatitis; and
``(E) carry out other activities that strengthen
the network of community support for individuals in
recovery.
``(e) Funding.--Of the amounts appropriated under section 101(a) of
the Opioid Use Disorder Treatment Expansion and Modernization Act for
fiscal year 2017, $25,000,000 shall be made available to carry out this
section, to remain available until expended''.
TITLE II--COMPREHENSIVE OPIOID ABUSE REDUCTION
SEC. 201. COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM.
(a) In General.--Title I of the Omnibus Crime Control and Safe
Streets Act of 1968 (42 U.S.C. 3711 et seq.) is amended by adding at
the end the following:
``PART LL--COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM
``SEC. 3021. DESCRIPTION.
``(a) Grants Authorized.--From amounts made available to carry out
this part, the Attorney General may make grants to States, units of
local government, and Indian tribes, for use by the State, unit of
local government, or Indian tribe to provide services primarily
relating to opioid abuse, including for any one or more of the
following:
``(1) Developing, implementing, or expanding a treatment
alternative to incarceration program, which may include--
``(A) pre-booking or post-booking components, which
may include the activities described in part HH of this
title;
``(B) training for criminal justice agency
personnel on substance use disorders and co-occurring
mental illness and substance use disorders;
``(C) a mental health court, including the
activities described in part V of this title;
``(D) a drug court, including the activities
described in part EE of this title; and
``(E) a veterans treatment court program, including
the activities described in subsection (i) of section
2991 of this title.
``(2) In the case of a State, facilitating or enhancing
planning and collaboration between State criminal justice
agencies and State substance abuse systems in order to more
efficiently and effectively carry out programs described in
paragraph (1) that address problems related to opioid abuse.
``(3) Providing training and resources for first responders
on carrying and administering an opioid overdose reversal drug
or device approved by the Food and Drug Administration, and
purchasing such a drug or device for first responders who have
received such training to carry and administer.
``(4) Investigative purposes to locate or investigate
illicit activities related to the unlawful distribution of
opioids.
``(5) Developing, implementing, or expanding a medication-
assisted treatment program used or operated by a criminal
justice agency, which may include training criminal justice
agency personnel on medication-assisted treatment, and carrying
out the activities described in part S of this title.
``(6) In the case of a State, developing, implementing, or
expanding a prescription drug monitoring program to collect and
analyze data related to the prescribing of schedule II, III,
and IV controlled substances through a centralized database
administered by an authorized State agency, which includes
tracking the dispensation of such substances, and providing for
data sharing with other States.
``(7) Developing, implementing, or expanding a program to
prevent and address opioid abuse by juveniles.
``(8) Developing, implementing, or expanding an integrated
and comprehensive opioid abuse response program.
``(b) Contracts and Subawards.--A State, unit of local government,
or Indian tribe may, in using a grant under this subpart for purposes
authorized by subsection (a), use all or a portion of that grant to
contract with or make one or more subawards to one or more--
``(1) local or regional organizations that are private and
nonprofit, including faith-based organizations;
``(2) units of local government; or
``(3) tribal organizations.
``(c) Program Assessment Component; Waiver.--
``(1) Program assessment component.--Each program funded
under this subpart shall contain a program assessment
component, developed pursuant to guidelines established by the
Attorney General, in coordination with the National Institute
of Justice.
``(2) Waiver.--The Attorney General may waive the
requirement of paragraph (1) with respect to a program if, in
the opinion of the Attorney General, the program is not of
sufficient size to justify a full program assessment.
``(d) Administrative Costs.--Not more than 10 percent of a grant
made under this subpart may be used for costs incurred to administer
such grant.
``(e) Period.--The period of a grant made under this part may not
be longer than 4 years, except that renewals and extensions beyond that
period may be granted at the discretion of the Attorney General.
``SEC. 3022. APPLICATIONS.
``To request a grant under this part, the chief executive officer
of a State, unit of local government, or Indian tribe shall submit an
application to the Attorney General at such time and in such form as
the Attorney General may require. Such application shall include the
following:
``(1) A certification that Federal funds made available
under this subpart will not be used to supplant State, local,
or tribal funds, but will be used to increase the amounts of
such funds that would, in the absence of Federal funds, be made
available for the activities described in section 3021(a).
``(2) An assurance that, for each fiscal year covered by an
application, the applicant shall maintain and report such data,
records, and information (programmatic and financial) as the
Attorney General may reasonably require.
``(3) A certification, made in a form acceptable to the
Attorney General and executed by the chief executive officer of
the applicant (or by another officer of the applicant, if
qualified under regulations promulgated by the Attorney
General), that--
``(A) the programs to be funded by the grant meet
all the requirements of this part;
``(B) all the information contained in the
application is correct;
``(C) there has been appropriate coordination with
affected agencies; and
``(D) the applicant will comply with all provisions
of this part and all other applicable Federal laws.
``(4) An assurance that the applicant will work with the
Drug Enforcement Administration to develop an integrated and
comprehensive strategy to address opioid abuse.
``SEC. 3023. REVIEW OF APPLICATIONS.
``The Attorney General shall not finally disapprove any application
(or any amendment to that application) submitted under this part
without first affording the applicant reasonable notice of any
deficiencies in the application and opportunity for correction and
reconsideration.
``SEC. 3024. GEOGRAPHIC DIVERSITY.
``The Attorney General shall ensure equitable geographic
distribution of grants under this part and take into consideration the
needs of underserved populations, including rural and tribal
communities.
``SEC. 3025. DEFINITIONS.
``In this part:
``(1) The term `first responder' includes a firefighter,
law enforcement officer, paramedic, emergency medical
technician, or other individual (including an employee of a
legally organized and recognized volunteer organization,
whether compensated or not), who, in the course of professional
duties, responds to fire, medical, hazardous material, or other
similar emergencies.
``(2) The term `medication-assisted treatment' means the
use of medications approved by the Food and Drug Administration
for the treatment of opioid abuse.
``(3) The term `opioid' means any drug, including heroin,
having an addiction-forming or addiction-sustaining liability
similar to morphine or being capable of conversion into a drug
having such addiction-forming or addiction-sustaining
liability.
``(4) The term `schedule II, III, or IV controlled
substance' means a controlled substance that is listed on
schedule II, schedule III, or schedule IV of section 202(c) of
the Controlled Substances Act (21 U.S.C. 812(c)).
``(5) The terms `drug' and `device' have the meanings given
those terms in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321).
``(6) The term `criminal justice agency' means a State,
local, or tribal--
``(A) court;
``(B) prison;
``(C) jail;
``(D) law enforcement agency; or
``(E) other agency that performs the administration
of criminal justice, including prosecution, pretrial
services, and community supervision.
``(7) The term `tribal organization' has the meaning given
that term in section 4 of the Indian Self-Determination and
Education Assistance Act (25 U.S.C. 450b).''.
(b) Funding.--There is authorized to be appropriated $65,000,000 to
carry out this section, section 203, and section 204 (including the
amendments made by such sections) for the period of fiscal years 2017
through 2021, of which $65,000,000 shall be made available from amounts
appropriated under section 101(a) of the Opioid Use Disorder Treatment
Expansion and Modernization Act for fiscal year 2017, to remain
available until expended.
SEC. 202. AUDIT AND ACCOUNTABILITY OF GRANTEES.
(a) Definitions.--In this section--
(1) the term ``covered grant program'' means a grant
program operated by the Department of Justice;
(2) the term ``covered grantee'' means a recipient of a
grant from a covered grant program;
(3) the term ``nonprofit'', when used with respect to an
organization, means an organization that is described in
section 501(c)(3) of the Internal Revenue Code of 1986, and is
exempt from taxation under section 501(a) of such Code; and
(4) the term ``unresolved audit finding'' means an audit
report finding in a final audit report of the Inspector General
of the Department of Justice that a covered grantee has used
grant funds awarded to that grantee under a covered grant
program for an unauthorized expenditure or otherwise
unallowable cost that is not closed or resolved during a 12-
month period prior to the date on which the final audit report
is issued.
(b) Audit Requirement.--Beginning in fiscal year 2016, and annually
thereafter, the Inspector General of the Department of Justice shall
conduct audits of covered grantees to prevent waste, fraud, and abuse
of funds awarded under covered grant programs. The Inspector General
shall determine the appropriate number of covered grantees to be
audited each year.
(c) Mandatory Exclusion.--A grantee that is found to have an
unresolved audit finding under an audit conducted under subsection (b)
may not receive grant funds under a covered grant program in the fiscal
year following the fiscal year to which the finding relates.
(d) Reimbursement.--If a covered grantee is awarded funds under the
covered grant program from which it received a grant award during the
1-fiscal-year period during which the covered grantee is ineligible for
an allocation of grant funds under subsection (c), the Attorney General
shall--
(1) deposit into the General Fund of the Treasury an amount
that is equal to the amount of the grant funds that were
improperly awarded to the covered grantee; and
(2) seek to recoup the costs of the repayment to the Fund
from the covered grantee that was improperly awarded the grant
funds.
(e) Priority of Grant Awards.--The Attorney General, in awarding
grants under a covered grant program shall give priority to eligible
entities that during the 2-year period preceding the application for a
grant have not been found to have an unresolved audit finding.
(f) Nonprofit Requirements.--
(1) Prohibition.--A nonprofit organization that holds money
in offshore accounts for the purpose of avoiding the tax
described in section 511(a) of the Internal Revenue Code of
1986, shall not be eligible to receive, directly or indirectly,
any funds from a covered grant program.
(2) Disclosure.--Each nonprofit organization that is a
covered grantee shall disclose in its application for such a
grant, as a condition of receipt of such a grant, the
compensation of its officers, directors, and trustees. Such
disclosure shall include a description of the criteria relied
on to determine such compensation.
SEC. 203. VETERANS TREATMENT COURTS.
Section 2991 of the Omnibus Crime Control and Safe Streets Act of
1968 (42 U.S.C. 3797aa) is amended--
(1) by redesignating subsection (i) as subsection (j); and
(2) by inserting after subsection (h) the following:
``(i) Assisting Veterans.--
``(1) Definitions.--In this subsection:
``(A) Peer to peer services or programs.--The term
`peer to peer services or programs' means services or
programs that connect qualified veterans with other
veterans for the purpose of providing support and
mentorship to assist qualified veterans in obtaining
treatment, recovery, stabilization, or rehabilitation.
``(B) Qualified veteran.--The term `qualified
veteran' means a preliminarily qualified offender who--
``(i) served on active duty in any branch
of the Armed Forces, including the National
Guard or Reserves; and
``(ii) was discharged or released from such
service under conditions other than
dishonorable.
``(C) Veterans treatment court program.--The term
`veterans treatment court program' means a court
program involving collaboration among criminal justice,
veterans, and mental health and substance abuse
agencies that provides qualified veterans with--
``(i) intensive judicial supervision and
case management, which may include random and
frequent drug testing where appropriate;
``(ii) a full continuum of treatment
services, including mental health services,
substance abuse services, medical services, and
services to address trauma;
``(iii) alternatives to incarceration; or
``(iv) other appropriate services,
including housing, transportation, mentoring,
employment, job training, education, or
assistance in applying for and obtaining
available benefits.
``(2) Veterans assistance program.--
``(A) In general.--The Attorney General, in
consultation with the Secretary of Veterans Affairs,
may award grants under this subsection to applicants to
establish or expand--
``(i) veterans treatment court programs;
``(ii) peer to peer services or programs
for qualified veterans;
``(iii) practices that identify and provide
treatment, rehabilitation, legal, transitional,
and other appropriate services to qualified
veterans who have been incarcerated; or
``(iv) training programs to teach criminal
justice, law enforcement, corrections, mental
health, and substance abuse personnel how to
identify and appropriately respond to incidents
involving qualified veterans.
``(B) Priority.--In awarding grants under this
subsection, the Attorney General shall give priority to
applications that--
``(i) demonstrate collaboration between and
joint investments by criminal justice, mental
health, substance abuse, and veterans service
agencies;
``(ii) promote effective strategies to
identify and reduce the risk of harm to
qualified veterans and public safety; and
``(iii) propose interventions with
empirical support to improve outcomes for
qualified veterans.''.
SEC. 204. EMERGENCY FEDERAL LAW ENFORCEMENT ASSISTANCE.
Section 609Y(a) of the Justice Assistance Act of 1984 (42 U.S.C.
10513(a)) is amended by striking ``September 30, 1984'' and inserting
``September 30, 2021''.
SEC. 205. OPIOID PROGRAM EVALUATION ACT.
(a) Short Title.--This section may be cited as the ``Opioid Program
Evaluation Act'' or the ``OPEN Act''.
(b) Evaluation of Performance of Department of Justice Program.--
(1) Evaluation of justice department comprehensive opioid
abuse grant program.--Not later than 5 years after the date of
enactment of this Act, the Attorney General shall complete an
evaluation of the effectiveness of the Comprehensive Opioid
Abuse Grant Program under part LL of the Omnibus Crime Control
and Safe Streets Act of 1968 administered by the Department of
Justice based upon the information reported under paragraph (4)
of this subsection.
(2) Interim evaluation.--Not later than 3 years after the
date of enactment of this Act, the Attorney General shall
complete an interim evaluation assessing the nature and extent
of the incidence of opioid abuse and illegal opioid
distribution in the United States.
(3) Metrics and outcomes for evaluation.--Not later than
180 days after the date of enactment of this Act, the Attorney
General shall identify outcomes that are to be achieved by
activities funded by the Comprehensive Opioid Grant Abuse
Program and the metrics by which the achievement of such
outcomes shall be determined.
(4) Metrics data collection.--The Attorney General shall
require grantees under the Comprehensive Opioid Abuse Grant
Program (and those receiving subawards under section 3021(b) of
part LL of the Omnibus Crime Control and Safe Streets Act of
1968) to collect and annually report to the Department of
Justice data based upon the metrics identified under paragraph
(3).
(5) Publication of data and findings.--
(A) Publication of outcomes and metrics.--The
Attorney General shall, not later than 30 days after
completion of the requirement under paragraph (3),
publish the outcomes and metrics identified under that
paragraph.
(B) Publication of evaluation.--In the case of the
interim evaluation under paragraph (2), and the final
evaluation under paragraph (1), the Secretary shall
arrange for an independent, external evaluator to, not
later than 90 days after such an evaluation is
completed, publish the results of such evaluation and
issue a report on such evaluation to the Committee on
the Judiciary of the House of Representatives and the
Committee on the Judiciary of the Senate. Such report
shall also be published along with the data used to
make such evaluation.
(6) Arrangement with the national academy of sciences.--For
purposes of paragraphs (1), (2), and (3), the Attorney General
shall enter into an arrangement with the National Academy of
Sciences.
(c) Evaluation of Performance of Department of Health and Human
Services Program.--
(1) Evaluation of justice department comprehensive opioid
abuse grant program.--Not later than 5 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall complete an evaluation of any program
administered by the Secretary that provides grants for the
primary purpose of providing assistance in addressing problems
pertaining to opioid abuse based upon the information reported
under paragraph (4) of this subsection.
(2) Interim evaluation.--Not later than 3 years after the
date of enactment of this Act, the Secretary shall complete an
interim evaluation assessing the nature and extent of the
incidence of opioid abuse and illegal opioid distribution in
the United States.
(3) Metrics and outcomes for evaluation.--Not later than
180 days after the date of enactment of this Act, the Secretary
shall identify outcomes that are to be achieved by activities
funded by the programs described in paragraph (1) and the
metrics by which the achievement of such outcomes shall be
determined.
(4) Metrics data collection.--The Secretary shall require
grantees under the programs described in paragraph (1) to
collect and annually report to the Department of Health and
Human Services data based upon the metrics identified under
paragraph (3).
(5) Publication of data and findings.--
(A) Publication of outcomes and metrics.--The
Secretary shall, not later than 30 days after
completion of the requirement under paragraph (3),
publish the outcomes and metrics identified under that
paragraph.
(B) Publication of evaluation.--In the case of the
interim evaluation under subparagraph (B), and each
final evaluation under paragraph (1), the Secretary
shall arrange for an independent, external evaluator
to, not later than 90 days after such an evaluation is
completed, publish the results of such evaluation and
issue a report on such evaluation to the Committee on
Energy and Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and Pensions
of the Senate. Such report shall also be published
along with the data used to make such evaluation.
(6) Arrangement with an independent, external evaluator.--
For purposes of paragraphs (1), (2), (3), and (5), the
Secretary shall enter into an arrangement with an independent,
external evaluator.
(d) Definition.--In this section, the term ``opioid'' has the
meaning given the term ``opiate'' in section 102 of the Controlled
Substances Act (21 U.S.C. 802).
(e) No Additional Funds Authorized.--No additional funds are
authorized to be appropriated to carry out this Act.
SEC. 206. GOOD SAMARITAN ASSESSMENT ACT.
(a) GAO Study on Good Samaritan Laws Pertaining to Treatment of
Opioid Overdoses.--The Comptroller General of the United States shall
submit to the Committee on the Judiciary of the House of
Representatives, the Committee on Oversight and Government Reform of
the House of Representatives, the Committee on the Judiciary of the
Senate, and the Committee on Homeland Security and Governmental Affairs
of the Senate a report on--
(1) the extent to which the Director of National Drug
Control Policy has reviewed Good Samaritan laws, and any
findings from such a review, including findings related to the
potential effects of such laws, if available;
(2) efforts by the Director to encourage the enactment of
Good Samaritan laws; and
(3) a compilation of Good Samaritan laws in effect in the
States, the territories, and the District of Columbia.
(b) Definitions.--In this section--
(1) the term ``Good Samaritan law'' means a law of a State
or unit of local government that exempts from criminal or civil
liability any individual who administers an opioid overdose
reversal drug or device, or who contacts emergency services
providers in response to an overdose; and
(2) the term ``opioid'' means any drug, including heroin,
having an addiction-forming or addiction-sustaining liability
similar to morphine or being capable of conversion into a drug
having such addiction-forming or addiction-sustaining
liability.
TITLE III--PROMOTING RESPONSIBLE OPIOID MANAGEMENT AND INCORPORATING
SCIENTIFIC EXPERTISE
SEC. 301. SHORT TITLE.
This title may be cited as the ``Promoting Responsible Opioid
Management and Incorporating Scientific Expertise Act'' or the ``Jason
Simcakoski PROMISE Act''.
Subtitle A--Opioid Therapy and Pain Management
SEC. 311. GUIDELINES ON MANAGEMENT OF OPIOID THERAPY BY DEPARTMENT OF
VETERANS AFFAIRS AND DEPARTMENT OF DEFENSE AND
IMPLEMENTATION OF SUCH GUIDELINES BY DEPARTMENT OF
VETERANS AFFAIRS.
(a) In General.--Not later than one year after the date of the
enactment of this Act, the Secretary of Veterans Affairs and the
Secretary of Defense shall jointly update the VA/DOD Clinical Practice
Guideline for Management of Opioid Therapy for Chronic Pain to include
the following:
(1) In accordance with subsection (b), common recommended
guidelines for safely prescribing opioids for the treatment of
chronic, non-cancer pain in outpatient settings as compiled by
the Director of the Centers for Disease Control and Prevention.
(2) Enhanced guidance with respect to--
(A) the administration of two or more drugs that
may result in a life-limiting drug-to-drug interaction,
including benzodiazepines;
(B) the treatment of patients with current acute
psychiatric instability or substance use disorder or
patients at risk of suicide; and
(C) the use of opioid therapy to treat mental
health disorders other than opioid use disorder.
(3) Enhanced guidance with respect to the treatment of
patients with behaviors or comorbidities, such as post-
traumatic stress disorder, psychiatric disorders, or a history
of substance abuse or addiction, that requires a consultation
or comanagement of opioid therapy with one or more specialists
in pain management, mental health, or addictions.
(4) Enhanced guidance with respect to the conduct by health
care providers of an effective assessment for patients
receiving opioid therapy, including patients on long-term
opioid therapy, to determine--
(A) whether opioid therapy is meeting the expected
goals of the patient and health care provider of
relieving pain, improving function, and providing
patient satisfaction; and
(B) whether opioid therapy should be continued.
(5) Guidance that each health care provider of the
Department of Veterans Affairs and the Department of Defense,
before initiating opioid therapy to treat a patient as part of
the comprehensive assessment conducted by the health care
provider, use the Opioid Therapy Risk Report tool of the
Department of Veterans Affairs (or successor tool), which shall
include the ability to access the most recent patient
information from the prescription drug monitoring program of
each State that has such a program to assess the risk for
adverse outcomes of opioid therapy for the patient, including
with respect to the concurrent use of controlled substances,
including benzodiazepines.
(6) Guidelines to govern the methodologies used by health
care providers of the Department of Veterans Affairs and the
Department of Defense to safely titrate and taper opioid
therapy when adjusting or discriminating the use of opioid
therapy, including with respect to--
(A) prescription of the lowest effective dose based
on patient need;
(B) use of opioid only for a limited period of
time; and
(C) augmentation of opioid therapy with other pain
management therapies and modalities.
(7) Guidelines with respect to appropriate case management
for patients receiving opioid therapy who transition between
inpatient and outpatient health care settings, which may
include the use of care transition plans.
(8) Guidelines with respect to appropriate transfer of case
management responsibility for patients receiving opioid therapy
who transition from receiving care furnished by the Secretary
of Defense to receiving care furnished by other health care
providers after the patient has been discharged or separated
from the Armed Forces.
(9) Enhanced standards with respect to the use of routine
and random urine drug tests for all patients before and during
opioid therapy to help prevent substance abuse, dependence, and
diversion, including--
(A) that such tests occur not less frequently than
once each year; and
(B) that health care providers appropriately
interpret and respond to the results from such tests to
tailor pain therapy, safeguards, and risk management
strategies to each patient.
(10) Guidance that health care providers discuss with
patients, before initiating opioid therapy, options for pain
management therapies without the use of opioids and options to
augment opioid therapy with other clinical and complementary
and integrative health services to minimize opioid dependence.
(b) Treatment of Certain Guidelines Developed After Deadline.--If
the Director of the Centers for Disease Control and Prevention issues
the guidelines described in paragraph (1) of subsection (a) after the
date on which the Secretary of Veterans Affairs and the Secretary of
Defense jointly update the VA/DOD Clinical Practice Guideline for
Management of Opioid Therapy for Chronic Pain pursuant to such
subsection, the Secretaries shall jointly modify the VA/DOD Clinical
Practice Guideline for Management of Opioid Therapy for Chronic Pain to
incorporate such guidelines of the Director.
(c) Consultation Before Update.--Before updating the guideline
under subsection (a), the Secretary of Veterans Affairs and the
Secretary of Defense shall jointly consult with the Pain Management
Working Group of the Department of Veterans Affairs-Department of
Defense Joint Executive Committee established by section 320 of title
38, United States Code.
(d) Definitions.--In this section:
(1) The term ``controlled substance'' has the meaning given
that term in section 102 of the Controlled Substances Act (21
U.S.C. 802).
(2) The term ``State'' means each of the several States,
territories, and possessions of the United States, the District
of Columbia, and the Commonwealth of Puerto Rico.
SEC. 312. IMPROVEMENT OF OPIOID SAFETY MEASURES BY DEPARTMENT OF
VETERANS AFFAIRS.
(a) Expansion of Opioid Safety Initiative.--Not later than 180 days
after the date of the enactment of this Act, the Secretary of Veterans
Affairs shall expand the Opioid Safety Initiative of the Department of
Veterans Affairs to include all medical facilities of the Department.
(b) Pain Management Education and Training.--
(1) In general.--In carrying out the Opioid Safety
Initiative of the Department, the Secretary shall require all
employees of the Department responsible for prescribing opioids
to receive education and training described in paragraph (2).
(2) Education and training.--Education and training
described in this paragraph is education and training on pain
management and safe opioid prescribing practices for purposes
of safely and effectively managing patients with chronic pain,
including education and training on the following:
(A) The implementation of and full compliance with
the VA/DOD Clinical Practice Guideline for Management
of Opioid Therapy for Chronic Pain, including any
update to such guideline.
(B) The use of evidence-based pain management
therapies, including cognitive-behavioral therapy, non-
opioid alternatives, and non-drug methods and
procedures to managing pain and related health
conditions including complementary alternative
medicines.
(C) Screening and identification of patients with
substance use disorder, including drug-seeking
behavior, before prescribing opioids, assessment of
risk potential for patients developing an addiction,
and referral of patients to appropriate addiction
treatment professionals if addiction is identified or
strongly suspected.
(D) Communication with patients on the potential
harm associated with the use of opioids and other
controlled substances, including the need to safely
store and dispose of supplies relating to the use of
opioids and other controlled substances.
(E) Such other education and training as the
Secretary considers appropriate to ensure that veterans
receive safe and high-quality pain management care from
the Department.
(3) Use of existing program.--In providing education and
training described in paragraph (2), the Secretary shall use
the Interdisciplinary Chronic Pain Management Training Team
Program of the Department (or success program).
(c) Pain Management Teams.--
(1) In general.--In carrying out the Opioid Safety
Initiative of the Department, the director of each medical
facility of the Department shall identify and designate a pain
management team of health care professionals, which may include
board certified pain medicine specialists, responsible for
coordinating and overseeing pain management therapy at such
facility for patients experiencing acute and chronic pain that
is non-cancer related.
(2) Establishment of protocols.--
(A) In general.--In consultation with the Directors
of each Veterans Integrated Service Network, the
Secretary shall establish standard protocols for the
designation of pain management teams at each medical
facility within the Department.
(B) Consultation on prescription of opioids.--Each
protocol established under subparagraph (A) shall
ensure that any health care provider without expertise
in prescribing analgesics or who has not completed the
education and training under subsection (b), including
a mental health care provider, does not prescribe
opioids to a patient unless that health care provider--
(i) consults with a health care provider
with pain management expertise or who is on the
pain management team of the medical facility;
and
(ii) refers the patient to the pain
management team for any subsequent
prescriptions and related therapy.
(3) Report.--
(A) In general.--Not later than one year after the
date of enactment of this Act, the director of each
medical facility of the Department shall submit to the
Under Secretary for Health and the director of the
Veterans Integrated Service Network in which the
medical facility is located a report identifying the
health care professionals that have been designated as
members of the pain management team at the medical
facility pursuant to paragraph (1).
(B) Elements.--Each report submitted under
subparagraph (A) with respect to a medical facility of
the Department shall include--
(i) a certification as to whether all
members of the pain management team at the
medical facility have completed the education
and training required under subsection (b); and
(ii) a plan for the management and referral
of patients to such pain management team if
health care providers without expertise in
prescribing analgesics prescribe opioid
medications to treat acute and chronic pain
that is non-cancer related.
(d) Tracking and Monitoring of Opioid Use.--
(1) Prescription drug monitoring programs of states.--In
carrying out the Opioid Safety Initiative and the Opioid
Therapy Risk Report tool of the Department, the Secretary
shall--
(A) ensure access by health care providers of the
Department to information on controlled substances,
including opioids and benzodiazepines, prescribed to
veterans who receive care outside the Department
through the prescription drug monitoring program of
each State with such a program, including by seeking to
enter into memoranda of understanding with States to
allow shared access of such information between States
and the Department;
(B) include such information in the Opioid Therapy
Risk Report; and
(C) require health care providers of the Department
to submit to the prescription drug monitoring program
of each State information on prescriptions of
controlled substances received by veterans in that
State under the laws administered by the Secretary.
(2) Report on tracking of data on opioid use.--Not later
than 18 months after the date of the enactment of this Act, the
Secretary shall submit to the Committee on Veterans' Affairs of
the Senate and the Committee on Veterans' Affairs of the House
of Representatives a report on the feasibility and advisability
of improving the Opioid Therapy Risk Report tool of the
Department to allow for more advanced real-time tracking of and
access to data on--
(A) the key clinical indicators with respect to the
totality of opioid use by veterans;
(B) concurrent prescribing by health care providers
of the Department of opioids in different health care
settings, including data on concurrent prescribing of
opioids to treat mental health disorders other than
opioid use disorder; and
(C) mail-order prescriptions of opioid prescribed
to veterans under the laws administered by the
Secretary.
(e) Availability of Opioid Receptor Antagonists.--
(1) Increased availability and use.--
(A) In general.--The Secretary shall maximize the
availability of opioid receptor antagonists approved by
the Food and Drug Administration, including naloxone,
to veterans.
(B) Availability, training, and distributing.--In
carrying out subparagraph (A), not later than 90 days
after the date of the enactment of this Act, the
Secretary shall--
(i) equip each pharmacy of the Department
with opioid receptor antagonists approved by
the Food and Drug Administration to be
dispensed to outpatients as needed; and
(ii) expand the Overdose Education and
Naloxone Distribution program of the Department
to ensure that all veterans in receipt of
health care under laws administered by the
Secretary who are at risk of opioid overdose
may access such opioid receptor antagonists and
training on the proper administration of such
opioid receptor antagonists.
(C) Veterans who are at risk.--For purposes of
subparagraph (B), veterans who are at risk of opioid
overdose include--
(i) veterans receiving long-term opioid
therapy;
(ii) veterans receiving opioid therapy who
have a history of substance use disorder or
prior instances of overdose; and
(iii) veterans who are at risk as
determined by a health care provider who is
treating the veteran.
(2) Report.--Not later than 120 days after the date of the
enactment of this Act, the Secretary shall submit to the
Committee on Veterans' Affairs of the Senate and the Committee
on Veterans' Affairs of the House of Representatives a report
on carrying out paragraph (1), including an assessment of any
remaining steps to be carried out by the Secretary to carry out
such paragraph.
(f) Inclusion of Certain Information and Capabilities in Opioid
Therapy Risk Report Tool of the Department.--
(1) Information.--The Secretary shall include in the Opioid
Therapy Risk Report tool of the Department--
(A) information on the most recent time the tool
was accessed by a health care provider of the
Department with respect to each veteran; and
(B) information on the results of the most recent
urine drug test for each veteran.
(2) Capabilities.--The Secretary shall include in the
Opioid Therapy Risk Report tool the ability of the health care
providers of the Department to determine whether a health care
provider of the Department prescribed opioids to a veteran
without checking the information in the tool with respect to
the veteran.
(g) Notifications of Risk in Computerized Health Record.--The
Secretary shall modify the computerized patient record system of the
Department to ensure that any health care provider that accesses the
record of a veteran, regardless of the reason the veteran seeks care
from the health care provider, will be immediately notified whether the
veteran--
(1) is receiving opioid therapy and has a history of
substance use disorder or prior instances of overdose;
(2) has a history of opioid abuse; or
(3) is at risk of becoming an opioid abuser as determined
by a health care provider who is treating the veteran.
(h) Definitions.--In this section:
(1) The term ``controlled substance'' has the meaning given
that term in section 102 of the Controlled Substances Act (21
U.S.C. 802).
(2) The term ``State'' means each of the several States,
territories, and possessions of the United States, the District
of Columbia, and the Commonwealth of Puerto Rico.
SEC. 313. STRENGTHENING OF JOINT WORKING GROUP ON PAIN MANAGEMENT OF
THE DEPARTMENT OF VETERANS AFFAIRS AND THE DEPARTMENT OF
DEFENSE.
(a) In General.--Not later than 90 days after the date of enactment
of this Act, the Secretary of Veterans Affairs and the Secretary of
Defense shall ensure that the Pain Management Working Group of the
Health Executive Committee of the Department of Veterans Affairs-
Department of Defense Joint Executive Committee established under
section 320 of title 38, United States Code, includes a focus on the
following:
(1) The opioid prescribing practices of health care
providers of each Department.
(2) The ability of each Department to manage acute and
chronic pain among individuals receiving health care from the
Department, including training health care providers with
respect to pain management.
(3) The use by each Department of complementary and
integrative health and complementary alternative medicines in
treating such individuals.
(4) The concurrent use by health care providers of each
Department of opioids and prescription drugs to treat mental
health disorders, including benzodiazepines.
(5) The practice by health care providers of each
Department of prescribing opioids to treat mental health
disorders.
(6) The coordination in coverage of and consistent access
to medications prescribed for patients transitioning from
receiving health care from the Department of Defense to
receiving health care from the Department of Veterans Affairs.
(7) The ability of each Department to identify and treat
substance use disorders among individuals receiving health care
from that Department.
(b) Coordination and Consultation.--The Secretary of Veterans
Affairs and the Secretary of Defense shall ensure that the working
group described in subsection (a)--
(1) coordinates the activities of the working group with
other relevant working groups established under section 320 of
title 38, United States Code, including the working groups on
evidence-based practice, patient safety, pharmacy,
psychological health, and psychological health;
(2) consults with other relevant Federal agencies,
including the Centers for Disease Control and Prevention, with
respect to the activities of the working group; and
(3) consults with the Department of Veterans Affairs and
the Department of Defense with respect to, reviews, and
comments on the VA/DOD Clinical Practice Guideline for
Management of Opioid Therapy for Chronic Pain, or any successor
guideline, before any update to the guideline is released.
(c) Consultations.--The Secretary of Veterans Affairs and the
Secretary of Defense shall ensure that the working group described in
subsection (a) is able to meaningfully consult with respect to the
updated guideline required under subsection (a) of section 311, as
required by subsection (b) of such section, not later than 1 year after
the date of enactment of this Act.
SEC. 314. REVIEW, INVESTIGATION, AND REPORT ON USE OF OPIOIDS IN
TREATMENT BY DEPARTMENT OF VETERANS AFFAIRS.
(a) Comptroller General Report.--
(1) In general.--Not later than two years after the date of
the enactment of this Act, the Comptroller General of the
United States shall submit to the Committee on Veterans'
Affairs of the Senate and the Committee on Veterans' Affairs of
the House of Representatives a report on the Opioid Safety
Initiative of the Department of Veterans Affairs and the opioid
prescribing practices of health care providers of the
Department.
(2) Elements.--The report submitted under paragraph (1)
shall include the following:
(A) Recommendations on such improvements to the
Opioid Safety Initiative of the Department as the
Comptroller General considers appropriate.
(B) Information with respect to--
(i) deaths resulting from sentinel events
involving veterans prescribed opioids by a
health care provider of the Department;
(ii) overall prescription rates and
prescriptions indications of opioids to treat
non-cancer, non-palliative, and non-hospice
care patients;
(iii) the prescription rates and
prescriptions indications of benzodiazepines
and opioids concomitantly by health care
providers of the Department;
(iv) the practice by health care providers
of the Department of prescribing opioids to
treat patients without any pain, including to
treat patients with mental health disorders
other than opioid use disorder; and
(v) the effectiveness of opioid therapy for
patients receiving such therapy, including the
effectiveness of long-term opioid therapy.
(C) An evaluation of processes of the Department in
place to oversee opioid use among veterans, including
procedures to identify and remedy potential over-
prescribing of opioids by health care providers of the
Department.
(D) An assessment of the implementation by the
Secretary of the VA/DOD Clinical Practice Guideline for
Management of Opioid Therapy for Chronic Pain.
(b) Quarterly Progress Report on Implementation of Comptroller
General Recommendations.--Not later than two years after the date of
the enactment of this Act, and not later than 30 days after the end of
each quarter thereafter, the Secretary of Veterans Affairs shall submit
to the Committee on Veterans' Affairs of the Senate and the Committee
on Veterans' Affairs of the House of Representatives a progress report
detailing the actions by the Secretary during the period covered by the
report to address any outstanding findings and recommendations by the
Comptroller General of the United States under subsection (a) with
respect to the Veterans Health Administration.
(c) Annual Review of Prescription Rates.--Not later than one year
after the date of the enactment of this Act, and not less frequently
than annually for the following five years, the Secretary shall submit
to the Committee on Veterans' Affairs of the Senate and the Committee
on Veterans' Affairs of the House of Representatives a report, with
respect to each medical facility of the Department of Veterans Affairs,
to collect and review information on opioids prescribed by health care
providers at the facility to treat non-cancer, non-palliative, and non-
hospice care patients that contains, for the one-year period preceding
the submission of the report, the following:
(1) The number of patients and the percentage of the
patient population of the Department who were prescribed
benzodiazepines and opioids concurrently by a health care
provider of the Department.
(2) The number of patients and the percentage of the
patient population of the Department without any pain who were
prescribed opioids by a health care provider of the Department,
including those who were prescribed benzodiazepines and opioids
concurrently.
(3) The number of non-cancer, non-palliative, and non-
hospice care patients and the percentage of such patients who
were treated with opioids by a health care provider of the
Department on an inpatient-basis and who also received
prescription opioids by mail from the Department while being
treated on an inpatient-basis.
(4) The number of non-cancer, non-palliative, and non-
hospice care patients and the percentage of such patients who
were prescribed opioids concurrently by a health care provider
of the Department and a health care provider that is not health
care provider of the Department.
(5) With respect to each medical facility of the
Department, information on opioids prescribed by health care
providers at the facility to treat non-cancer, non-palliative,
and non-hospice care patients, including information on--
(A) the prescription rate at which each health care
provider at the facility prescribed benzodiazepines and
opioids concurrently to such patients and the aggregate
such prescription rate for all health care providers at
the facility;
(B) the prescription rate at which each health care
provider at the facility prescribed benzodiazepines or
opioids to such patients to treat conditions for which
benzodiazepines or opioids are not approved treatment
and the aggregate such prescription rate for all health
care providers at the facility;
(C) the prescription rate at which each health care
provider at the facility prescribed or dispensed mail-
order prescriptions of opioids to such patients while
such patients were being treated with opioids on an
inpatient-basis and the aggregate of such prescription
rate for all health care providers at the facility; and
(D) the prescription rate at which each health care
provider at the facility prescribed opioids to such
patients who were also concurrently prescribed opioids
by a health care provider that is not a health care
provider of the Department and the aggregate of such
prescription rates for all health care providers at the
facility.
(6) With respect to each medical facility of the
Department, the number of times a pharmacist at the facility
overrode a critical drug interaction warning with respect to an
interaction between opioids and another medication before
dispensing such medication to a veteran.
(d) Investigation of Prescription Rates.--If the Secretary
determines that a prescription rate with respect to a health care
provider or medical facility of the Department conflicts with or is
otherwise inconsistent with the standards of appropriate and safe care,
the Secretary shall--
(1) immediately notify the Committee on Veterans' Affairs
of the Senate and the Committee on Veterans' Affairs of the
House of Representatives of such determination, including
information relating to such determination, prescription rate,
and health care provider or medical facility, as the case may
be; and
(2) through the Office of the Medical Inspector of the
Veterans Health Administration, conduct a full investigation of
the health care provider or medical facility, as the case may
be.
(e) Prescription Rate Defined.--In this section, the term
``prescription rate'' means, with respect to a health care provider or
medical facility of the Department, each of the following:
(1) The number of patients treated with opioids by the
health care provider or at the medical facility, as the case
may be, divided by the total number of pharmacy users of that
health care provider or medical facility.
(2) The average number of morphine equivalents per day
prescribed by the health care provider or at the medical
facility, as the case may be, to patients being treated with
opioids.
(3) Of the patients being treated with opioids by the
health care provider or at the medical facility, as the case
may be, the average number of prescriptions of opioids per
patient.
Subtitle B--Patient Advocacy
SEC. 321. COMMUNITY MEETINGS ON IMPROVING CARE FURNISHED BY DEPARTMENT
OF VETERANS AFFAIRS.
(a) Community Meetings.--
(1) Medical centers.--Not later than 90 days after the date
of the enactment of this Act, and not less frequently than once
every 90 days thereafter, the Secretary shall ensure that each
medical facility of the Department of Veterans Affairs hosts a
community meeting open to the public on improving health care
furnished by the Secretary.
(2) Community based outpatient clinics.--Not later than one
year after the date of the enactment of this Act, and not less
frequently than annually thereafter, the Secretary shall ensure
that each community based outpatient clinic of the Department
hosts a community meeting open to the public on improving
health care furnished by the Secretary.
(b) Attendance by Director of Veterans Integrated Service Network
or Designee.--
(1) In general.--Each community meeting hosted by a medical
facility or community based outpatient clinic under subsection
(a) shall be attended by the Director of the Veterans
Integrated Service Network in which the medical facility or
community based outpatient clinic, as the case may be, is
located. Subject to paragraph (2), the Director may delegate
such attendance only to an employee who works in the Office of
the Director.
(2) Attendance by director.--Each Director of a Veterans
Integrated Service Network shall personally attend not less
than one community meeting under subsection (a) hosted by each
medical facility located in the Veterans Integrated Service
Network each year.
(c) Notice.--The Secretary shall notify the Committee on Veterans'
Affairs of the Senate, the Committee on Veterans' Affairs of the House
of Representatives, and each Member of Congress (as defined in section
314) who represents the area in which the medical facility is located
of a community meeting under subsection (a) by not later than 10 days
before such community meeting occurs.
SEC. 322. IMPROVEMENT OF AWARENESS OF PATIENT ADVOCACY PROGRAM AND
PATIENT BILL OF RIGHTS OF DEPARTMENT OF VETERANS AFFAIRS.
Not later than 90 days after the date of the enactment of this Act,
the Secretary of Veterans Affairs shall, in as many prominent locations
as the Secretary determines appropriate to be seen by the largest
percentage of patients and family members of patients at each medical
facility of the Department of Veterans Affairs--
(1) display the purposes of the Patient Advocacy Program of
the Department and the contact information for the patient
advocate at such medical facility; and
(2) display the rights and responsibilities of--
(A) patients and family members and patients at
such medical facility; and
(B) with respect to community living centers and
other residential facilities of the Department,
residents and family members of residents at such
medical facility.
SEC. 323. COMPTROLLER GENERAL REPORT ON PATIENT ADVOCACY PROGRAM OF
DEPARTMENT OF VETERANS AFFAIRS.
(a) In General.--Not later than two years after the date of the
enactment of this Act, the Comptroller General of the United States
shall submit to the Committee on Veterans' Affairs of the Senate and
the Committee on Veterans' Affairs of the House of Representatives a
report on the Patient Advocacy Program of the Department of Veterans
Affairs (in this section referred to as the ``Program'').
(b) Elements.--The report required by subsection (a) shall include
the following:
(1) A description of the Program, including--
(A) the purpose of the Program;
(B) the activities carried out under the Program;
and
(C) the sufficiency of the Program in achieving the
purpose of the Program.
(2) An assessment of the sufficiency of staffing of
employees of the Department responsible for carrying out the
Program.
(3) An assessment of the sufficiency of the training of
such employees.
(4) An assessment of--
(A) the awareness of the Program among veterans and
family members of veterans; and
(B) the use of the Program by veterans and family
members of veterans.
(5) Such recommendations and proposals for improving or
modifying the Program as the Comptroller General considers
appropriate.
(6) Such other information with respect to the Program as
the Comptroller General considers appropriate.
Subtitle C--Complementary and Integrative Health
SEC. 331. EXPANSION OF RESEARCH AND EDUCATION ON AND DELIVERY OF
COMPLEMENTARY AND INTEGRATIVE HEALTH TO VETERANS.
(a) Establishment.--There is established a commission to be known
as the ``Creating Options for Veterans' Expedited Recovery'' or the
``COVER Commission'' (in this Act referred to as the ``Commission'').
The Commission shall examine the evidence-based therapy treatment model
used by the Secretary of Veterans Affairs for treating mental health
conditions of veterans and the potential benefits of incorporating
complementary alternative treatments available in non-Department
facilities (as defined in section 1701 of title 38, United States
Code).
(b) Duties.--The Commission shall perform the following duties:
(1) Examine the efficacy of the evidence-based therapy
model used by the Secretary for treating mental health
illnesses of veterans and identify areas to improve wellness-
based outcomes.
(2) Conduct a patient-centered survey within each of the
Veterans Integrated Service Networks to examine--
(A) the experience of veterans with the Department
of Veterans Affairs when seeking medical assistance for
mental health issues through the health care system of
the Department;
(B) the experience of veterans with non-Department
facilities and health professionals for treating mental
health issues;
(C) the preference of veterans regarding available
treatment for mental health issues and which methods
the veterans believe to be most effective;
(D) the experience, if any, of veterans with
respect to the complementary alternative treatment
therapies described in paragraph (3);
(E) the prevalence of prescribing prescription
medication among veterans seeking treatment through the
health care system of the Department as remedies for
addressing mental health issues; and
(F) the outreach efforts of the Secretary regarding
the availability of benefits and treatments for
veterans for addressing mental health issues, including
by identifying ways to reduce barriers to gaps in such
benefits and treatments.
(3) Examine available research on complementary alternative
treatment therapies for mental health issues and identify what
benefits could be made with the inclusion of such treatments
for veterans, including with respect to--
(A) music therapy;
(B) equine therapy;
(C) training and caring for service dogs;
(D) yoga therapy;
(E) acupuncture therapy;
(F) meditation therapy;
(G) outdoor sports therapy;
(H) hyperbaric oxygen therapy;
(I) accelerated resolution therapy;
(J) art therapy;
(K) magnetic resonance therapy; and
(L) other therapies the Commission determines
appropriate.
(4) Study the sufficiency of the resources of the
Department to ensure the delivery of quality health care for
mental health issues among veterans seeking treatment within
the Department.
(5) Study the current treatments and resources available
within the Department and assess--
(A) the effectiveness of such treatments and
resources in decreasing the number of suicides per day
by veterans;
(B) the number of veterans who have been diagnosed
with mental health issues;
(C) the percentage of veterans using the resources
of the Department who have been diagnosed with mental
health issues;
(D) the percentage of veterans who have completed
counseling sessions offered by the Department; and
(E) the efforts of the Department to expand
complementary alternative treatments viable to the
recovery of veterans with mental health issues as
determined by the Secretary to improve the
effectiveness of treatments offered with the
Department.
(c) Membership.--
(1) In general.--The Commission shall be composed of 10
members, appointed as follows:
(A) Two members appointed by the Speaker of the
House of Representatives, at least one of whom shall be
a veteran.
(B) Two members appointed by the Minority Leader of
the House of Representatives, at least one of whom
shall be a veteran.
(C) Two members appointed by the Majority Leader of
the Senate, at least one of whom shall be a veteran.
(D) Two members appointed by the Minority Leader of
the Senate, at least one of whom shall be a veteran.
(E) Two members appointed by the President, at
least one of whom shall be a veteran.
(2) Qualifications.--Members of the Commission shall be--
(A) individuals who are of recognized standing and
distinction within the medical community with a
background in treating mental health;
(B) individuals with experience working with the
military and veteran population; and
(C) individuals who do not have a financial
interest in any of the complementary alternative
treatments reviewed by the Commission.
(3) Chairman.--The President shall designate a member of
the Commission to be the Chairman.
(4) Period of appointment.--Members of the Commission shall
be appointed for the life of the Commission.
(5) Vacancy.--A vacancy in the Commission shall be filled
in the manner in which the original appointment was made.
(6) Appointment deadline.--The appointment of members of
the Commission in this section shall be made not later than 90
days after the date of the enactment of this Act.
(d) Powers of Commission.--
(1) Meetings.--
(A) Initial meeting.--The Commission shall hold its
first meeting not later than 30 days after a majority
of members are appointed to the Commission.
(B) Meeting.--The Commission shall regularly meet
at the call of the Chairman. Such meetings may be
carried out through the use of telephonic or other
appropriate telecommunication technology if the
Commission determines that such technology will allow
the members to communicate simultaneously.
(2) Hearings.--The Commission may hold such hearings, sit
and act at such times and places, take such testimony, and
receive evidence as the Commission considers advisable to carry
out the responsibilities of the Commission.
(3) Information from federal agencies.--The Commission may
secure directly from any department or agency of the Federal
Government such information as the Commission considers
necessary to carry out the duties of the Commission.
(4) Information from nongovernmental organizations.--In
carrying out its duties, the Commission may seek guidance
through consultation with foundations, veteran service
organizations, nonprofit groups, faith-based organizations,
private and public institutions of higher education, and other
organizations as the Commission determines appropriate.
(5) Commission records.--The Commission shall keep an
accurate and complete record of the actions and meeting of the
Commission. Such record shall be made available for public
inspection and the Comptroller General of the United States may
audit and examine such record.
(6) Personnel records.--The Commission shall keep an
accurate and complete record of the actions and meetings of the
Commission. Such record shall be made available for public
inspection and the Comptroller General of the United States may
audit and examine such records.
(7) Compensation of members; travel expenses.--Each member
shall serve without pay but shall receive travel expenses to
perform the duties of the Commission, including per diem in
lieu of substances, at rates authorized under subchapter I of
chapter 57 of title 5, United States Code.
(8) Staff.--The Chairman, in accordance with rules agreed
upon the Commission, may appoint fix the compensation of a
staff director and such other personnel as may be necessary to
enable the Commission to carry out its functions, without
regard to the provisions of title 5, United States Code,
governing appointments in the competitive service, without
regard to the provision of chapter 51 and subchapter III of
chapter 53 of such title relating to classification and General
Schedule pay rates, except that no rate of pay fixed under this
paragraph may exceed the equivalent of that payable for a
position at a level IV of the Executive Schedule under section
5316 of title 5, United States Code.
(9) Personnel as federal employees.--
(A) In general.--The executive director and any
personnel of the Commission are employees under section
2105 of title 5, United States Code, for purpose of
chapters 63, 81, 83, 84, 85, 87, 89, and 90 of such
title.
(B) Members of the commission.--Subparagraph (A)
shall not be construed to apply to members of the
Commission.
(10) Contracting.--The Commission may, to such extent and
in such amounts as are provided in appropriations Acts, enter
into contracts to enable the Commission to discharge the duties
of the Commission under this Act.
(11) Expert and consultant service.--The Commission may
procure the services of experts and consultants in accordance
with section 3109 or title 5, United States Code, at rates not
to exceed the daily rate paid to a person occupying a position
at level IV of the Executive Schedule under section 3109 of
title 5, United States Code.
(12) Postal service.--The Commission may use the United
States mails in the same manner and under the same conditions
as departments and agencies of the United States.
(13) Physical facilities and equipment.--Upon the request
of the Commission, the Administrator of General Services shall
provide to the Commission, on a reimbursable basis, the
administrative support services necessary for the Commission to
carry out its responsibilities under this Act. These
administrative services may include human resource management,
budget, leasing accounting, and payroll services.
(e) Report.--
(1) Interim reports.--
(A) In general.--Not later than 60 days after the
date on which the Commission first meets, and each 30-
day period thereafter ending on the date on which the
Commission submits the final report under paragraph
(2), the Commission shall submit to the Committees on
Veterans' Affairs of the House of Representatives and
the Senate and the President a report detailing the
level of cooperation the Secretary of Veterans Affairs
(and the heads of other departments or agencies of the
Federal Government) has provided to the Commission.
(B) Other reports.--In carrying out its duties, at
times that the Commission determines appropriate, the
Commission shall submit to the Committee on Veterans'
Affairs of the House of Representatives and the Senate
and any other appropriate entities an interim report
with respect to the findings identified by the
Commission.
(2) Final report.--Not later than 18 months after the first
meeting of the Commission, the Commission shall submit to the
Committee on Veterans' Affairs of the House of Representatives
and the Senate, the President, and the Secretary of Veterans
Affairs a final report on the findings of the Commission. Such
report shall include the following:
(A) Recommendations to implement in a feasible,
timely, and cost efficient manner the solutions and
remedies identified within the findings of the
Commission pursuant to subsection (b).
(B) An analysis of the evidence-based therapy model
used by the Secretary of Veterans Affairs for treating
veterans with mental health care issues, and an
examination of the prevalence and efficacy of
prescription drugs as a means for treatment.
(C) The findings of the patient-centered survey
conducted within each of the Veterans Integrated
Service Networks pursuant to subsection (b)(2).
(D) An examination of complementary alternative
treatments described in subsection (b)(3) and the
potential benefits of incorporating such treatments in
the therapy models used by the Secretary for treating
veterans with mental health issues.
(3) Plan.--Not later than 90 days after the date on which
the Commission submits the final report under paragraph (2),
the Secretary of Veterans Affairs shall submit to the Committee
on Veterans' Affairs of the House of Representatives and the
Senate a report on the following:
(A) An action plan for implementing the
recommendations established by the Commission on such
solutions and remedies for improving wellness-based
outcomes for veterans with mental health care issues.
(B) A feasible timeframe on when the complementary
alternative treatments described in subsection (b)(3)
can be implemented Department-wide.
(C) With respect to each recommendation established
by the Commission, including any complementary
alternative treatment, that the Secretary determines is
not appropriate or feasible to implement, a
justification for such determination and an alternative
solution to improve the efficacy of the therapy models
used by the Secretary for treating veterans with mental
health issues.
(f) Termination of Commission.--The Commission shall terminate 30
days after the Commission submits the final report under subsection
(e)(2).
SEC. 332. PILOT PROGRAM ON INTEGRATION OF COMPLEMENTARY ALTERNATIVE
MEDICINES AND RELATED ISSUES FOR VETERANS AND FAMILY
MEMBERS OF VETERANS.
(a) Pilot Program.--
(1) In general.--Not later than 180 days after the date on
which the Secretary of Veterans Affairs receives the final
report under section 331(e), the Secretary shall commence a
pilot program to assess the feasibility and advisability of
using wellness-based programs (as defined by the Secretary) to
complement the provision of pain management and related health
care services, including mental health care services, to
veterans.
(2) Matters addressed.--In carrying out the pilot program,
the Secretary shall assess the following:
(A) Means of improving coordination between
Federal, State, local, and community providers of
health care in the provision of pain management and
related health care services to veterans.
(B) Means of enhancing outreach, and coordination
of outreach, by and among providers of health care
referred to in subparagraph (A) on the pain management
and related health care services available to veterans.
(C) Means of using wellness-based programs of
providers of health care referred to in subparagraph
(A) as complements to the provision by the Department
of pain management and related health care services to
veterans.
(D) Whether wellness-based programs described in
subparagraph (C)--
(i) are effective in enhancing the quality
of life and well-being of veterans;
(ii) are effective in increasing the
adherence of veterans to the primary pain
management and related health care services
provided such veterans by the Department;
(iii) have an effect on the sense of well-
being of veterans who receive primary pain
management and related health care services
from the Department; and
(iv) are effective in encouraging veterans
receiving health care from the Department to
adopt a more healthy lifestyle.
(b) Duration.--The Secretary shall carry out the pilot program
under subsection (a)(1) for a period of three years.
(c) Locations.--
(1) Facilities.--The Secretary shall carry out the pilot
program under subsection (a)(1) at facilities of the Department
providing pain management and related health care services,
including mental health care services, to veterans. In
selecting such facilities to carry out the pilot program, the
Secretary shall select not fewer than 15 medical centers of the
Department, of which not fewer than two shall be polytrauma
rehabilitation centers of the Department.
(2) Medical centers with prescription rates of opioids that
conflict with care standards.--In selecting the medical centers
under paragraph (1), the Secretary shall give priority to
medical centers of the Department at which there is a
prescription rate of opioids that conflicts with or is
otherwise inconsistent with the standards of appropriate and
safe care.
(d) Provision of Services.--Under the pilot program under
subsection (a)(1), the Secretary shall provide covered services to
covered veterans by integrating complementary and alternative medicines
and integrative health services with other services provided by the
Department at the medical centers selected under subsection (c).
(e) Covered Veterans.--For purposes of the pilot program under
subsection (a)(1), a covered veteran is any veteran who--
(1) has a mental health condition diagnosed by a clinician
of the Department;
(2) experiences chronic pain;
(3) has a chronic condition being treated by a clinician of
the Department; or
(4) is not described in paragraph (1), (2), or (3) and
requests to participate in the pilot program or is referred by
a clinician of the Department who is treating the veteran.
(f) Covered Services.--
(1) In general.--For purposes of the pilot program, covered
services are services consisting of complementary and
integrative health services as selected by the Secretary.
(2) Administration of services.--Covered services shall be
administered under the pilot program as follows:
(A) Covered services shall be administered by
professionals or other instructors with appropriate
training and expertise in complementary and integrative
health services who are employees of the Department or
with whom the Department enters into an agreement to
provide such services.
(B) Covered services shall be included as part of
the Patient Aligned Care Teams initiative of the Office
of Patient Care Services, Primary Care Program Office,
in coordination with the Office of Patient Centered
Care and Cultural Transformation.
(C) Covered services shall be made available to--
(i) covered veterans who have received
conventional treatments from the Department for
the conditions for which the covered veteran
seeks complementary and integrative health
services under the pilot program; and
(ii) covered veterans who have not received
conventional treatments from the Department for
such conditions.
(g) Reports.--
(1) In general.--Not later than 30 months after the date on
which the Secretary commences the pilot program under
subsection (a)(1), the Secretary shall submit to the Committee
on Veterans' Affairs of the Senate and the Committee on
Veterans' Affairs of the House of Representatives a report on
the pilot program.
(2) Elements.--The report under paragraph (1) shall include
the following:
(A) The findings and conclusions of the Secretary
with respect to the pilot program under subsection
(a)(1), including with respect to--
(i) the use and efficacy of the
complementary and integrative health services
established under the pilot program;
(ii) the outreach conducted by the
Secretary to inform veterans and community
organizations about the pilot program; and
(iii) an assessment of the benefit of the
pilot program to covered veterans in mental
health diagnoses, pain management, and
treatment of chronic illness.
(B) Identification of any unresolved barriers that
impede the ability of the Secretary to incorporate
complementary and integrative health services with
other health care services provided by the Department.
(C) Such recommendations for the continuation or
expansion of the pilot program as the Secretary
considers appropriate.
(h) Complementary and Integrative Health Defined.--In this section,
the term ``complementary and integrative health'' shall have the
meaning given that term by the National Institutes of Health.
Subtitle D--Fitness of Health Care Providers
SEC. 341. ADDITIONAL REQUIREMENTS FOR HIRING OF HEALTH CARE PROVIDERS
BY DEPARTMENT OF VETERANS AFFAIRS.
As part of the hiring process for each health care provider
considered for a position at the Department of Veterans Affairs after
the date of the enactment of the Act, the Secretary of Veterans Affairs
shall require from the medical board of each State in which the health
care provider has a medical license--
(1) information on any violation of the requirements of the
medical license of the health care provider during the 20-year
period preceding the consideration of the health care provider
by the Department; and
(2) information on whether the health care provider has
entered into any settlement agreement for the disciplinary
charge relating to the practice of medicine by the health care
provider.
SEC. 342. PROVISION OF INFORMATION ON HEALTH CARE PROVIDERS OF
DEPARTMENT OF VETERANS AFFAIRS TO STATE MEDICAL BOARDS.
Notwithstanding section 552a of title 5, United States Code, with
respect to each health care provider of the Department of Veterans
Affairs who has violated a requirement of the medical license of the
health care provider, the Secretary of Veterans Affairs shall provide
to the medical board of each State in which the health care provider is
licensed detailed information with respect to such violation,
regardless of whether such board has formally requested such
information.
SEC. 343. REPORT ON COMPLIANCE BY DEPARTMENT OF VETERANS AFFAIRS WITH
REVIEWS OF HEALTH CARE PROVIDERS LEAVING THE DEPARTMENT
OR TRANSFERRING TO OTHER FACILITIES.
Not later than two years after the date of the enactment of this
Act, the Secretary of Veterans Affairs shall submit to the Committee on
Veterans' Affairs of the Senate and the Committee on Veterans' Affairs
of the House of Representatives a report on the compliance by the
Department of Veterans Affairs with the policy of the Department--
(1) to conduct a review of each health care provider of the
Department who transfers to another medical facility of the
Department, retires, or is terminated to determine whether
there are any concerns, complaints, or allegations of
violations relating to the medical practice of the health care
provider; and
(2) to take appropriate action with respect to any such
concern, complaint, or allegation.
Subtitle E--Other Veterans Matters
SEC. 351. AUDIT OF VETERANS HEALTH ADMINISTRATION PROGRAMS OF
DEPARTMENT OF VETERANS AFFAIRS.
(a) Audit.--The Secretary of Veterans Affairs shall seek to enter
into a contract with a nongovernmental entity under which the entity
shall conduct a audits of the programs of the Veterans Health
Administration of the Department of Veterans Affairs to identify ways
to improve the furnishing of benefits and health care administered by
the Veterans Health Administration to veterans and families of
veterans.
(b) Audit Requirements.--In carrying out each audit under
subsection (a), the entity shall perform the following:
(1) Five-year risk assessments to identify the functions,
staff organizations, and staff offices of the Veterans Health
Administration that would lead towards the greatest improvement
in furnishing of benefits and health care to veterans and
families of veterans.
(2) Development of plans that are informed by the risk
assessment under paragraph (1) to conduct audits of the
functions, staff organizations, and staff offices identified
under paragraph (1).
(3) Conduct audits in accordance with the plans developed
pursuant to paragraph (2).
(c) Reports.--Not later than 90 days after the date on which each
audit is completed under subsection (a), the Secretary shall submit to
the Committees on Veterans' Affairs of the House of Representatives and
the Senate a report that includes--
(1) a summary of the audit;
(2) the findings of the entity that conducted the audit
with respect to the audit; and
(3) such recommendations as the Secretary determines
appropriate for legislative or administrative action to improve
the furnishing of benefits and health care to veterans and
families of veterans.
TITLE IV--IMPROVING SAFE CARE FOR PREVENTING INFANT ABUSE AND NEGLECT
SEC. 401. SHORT TITLE.
This title may be cited as the ``Improving Safe Care for the
Prevention of Infant Abuse and Neglect Act''.
SEC. 402. BEST PRACTICES FOR DEVELOPMENT OF PLANS OF SAFE CARE.
Section 103(b) of the Child Abuse Prevention and Treatment Act (42
U.S.C. 5104(b)) is amended--
(1) by redesignating paragraphs (5) through (8) as
paragraphs (6) through (9), respectively; and
(2) by inserting after paragraph (4), the following:
``(5) maintain and disseminate information about the best
practices relating to the development of plans of safe care as
described in section 106(b)(2)(B)(iii) for infants born and
identified as being affected by illegal substance abuse or
withdrawal symptoms, or a Fetal Alcohol Spectrum Disorder;''.
SEC. 403. STATE PLANS.
Section 106(b)(2)(B)(iii) of the Child Abuse Prevention and
Treatment Act (42 U.S.C. 5106a(b)(2)(B)(iii)) is amended by inserting
before the period at the end the following: ``to ensure the safety and
well-being of such infant following release from the care of healthcare
providers, including through addressing the health of the affected
family or caregiver''.
SEC. 404. DATA REPORTS.
(a) In General.--Section 106(d) of the Child Abuse Prevention and
Treatment Act (42 U.S.C. 5106a(d)) is amended by adding at the end of
the following:
``(17) The total number of infants--
``(A) identified under subsection (b)(2)(B)(ii);
``(B) for whom a plan of safe care was developed
under subsection (b)(2)(B)(iii); and
``(C) for whom referrals are made for appropriate
services, including services for the affected family or
caregiver, as may be necessary under subsection
(b)(2)(B)(iii).''.
(b) Redesignation.--Effective on May 29, 2017, section 106(d) of
the Child Abuse Prevention and Treatment Act (42 U.S.C. 5106a(d)) is
amended by redesignating paragraph (17) (as added by subsection (a)) as
paragraph (18).
SEC. 405. MONITORING AND OVERSIGHT.
(a) Amendment.--Title I of the Child Abuse Prevention and Treatment
Act (42 U.S.C. 5101 et seq.) is further amended by adding at the end
the following:
``SEC. 114. MONITORING AND OVERSIGHT.
``The Secretary shall conduct monitoring to ensure that each State
that receives a grant under section 106 is in compliance with the
requirements of section 106(b), which--
``(1) shall--
``(A) be in addition to the review of the State
plan upon its submission under section 106(b)(1)(A);
and
``(B) include monitoring of State policies and
procedures required under clauses (ii) and (iii) of
section 106(b)(2)(B); and
``(2) may include--
``(A) a comparison of activities carried out by the
State to comply with the requirements of section 106(b)
with the State plan most recently approved under
section 432 of the Social Security Act;
``(B) information available on the Website of the
State relating to its compliance with the requirements
of section 106(b);
``(C) site visits, as may be necessary to carry out
such monitoring; and
``(D) information available in the State's Annual
Progress and Services Report most recently submitted
under section 1357.16 of title 45, Code of Federal
Regulations (or successor regulations).''.
(b) Table of Contents.--The table of contents in section 1(b) of
the Child Abuse Prevention and Treatment Act (42 U.S.C. 5101 note) is
amended by inserting after the item relating to section 113, the
following:
``Sec. 114. Monitoring and oversight.''.
SEC. 406. RULE OF CONSTRUCTION.
Nothing in this Act shall be construed to authorize the Secretary
of Health and Human Services or any other officer of the Federal
Government to add new requirements to section 106(b) of the Child Abuse
Prevention and Treatment Act (42 U.S.C. 5106a(b)), as amended by this
Act.
TITLE V--OTHER PROVISIONS
SEC. 501. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER MEDICARE
PARTS C AND D.
(a) Drug Management Program for At-Risk Beneficiaries.--
(1) In general.--Section 1860D-4(c) of the Social Security
Act (42 U.S.C. 1395w-10(c)) is amended by adding at the end the
following:
``(5) Drug management program for at-risk beneficiaries.--
``(A) Authority to establish.--A PDP sponsor may
establish a drug management program for at-risk
beneficiaries under which, subject to subparagraph (B),
the PDP sponsor may, in the case of an at-risk
beneficiary for prescription drug abuse who is an
enrollee in a prescription drug plan of such PDP
sponsor, limit such beneficiary's access to coverage
for frequently abused drugs under such plan to
frequently abused drugs that are prescribed for such
beneficiary by one or more prescribers selected under
subparagraph (D), and dispensed for such beneficiary by
one or more pharmacies selected under such
subparagraph.
``(B) Requirement for notices.--
``(i) In general.--A PDP sponsor may not
limit the access of an at-risk beneficiary for
prescription drug abuse to coverage for
frequently abused drugs under a prescription
drug plan until such sponsor--
``(I) provides to the beneficiary
an initial notice described in clause
(ii) and a second notice described in
clause (iii); and
``(II) verifies with the providers
of the beneficiary that the beneficiary
is an at-risk beneficiary for
prescription drug abuse.
``(ii) Initial notice.--An initial notice
described in this clause is a notice that
provides to the beneficiary--
``(I) notice that the PDP sponsor
has identified the beneficiary as
potentially being an at-risk
beneficiary for prescription drug
abuse;
``(II) information describing all
State and Federal public health
resources that are designed to address
prescription drug abuse to which the
beneficiary has access, including
mental health services and other
counseling services;
``(III) notice of, and information
about, the right of the beneficiary to
appeal such identification under
subsection (h) and the option of an
automatic escalation to external
review;
``(IV) a request for the
beneficiary to submit to the PDP
sponsor preferences for which
prescribers and pharmacies the
beneficiary would prefer the PDP
sponsor to select under subparagraph
(D) in the case that the beneficiary is
identified as an at-risk beneficiary
for prescription drug abuse as
described in clause (iii)(I);
``(V) an explanation of the meaning
and consequences of the identification
of the beneficiary as potentially being
an at-risk beneficiary for prescription
drug abuse, including an explanation of
the drug management program established
by the PDP sponsor pursuant to
subparagraph (A);
``(VI) clear instructions that
explain how the beneficiary can contact
the PDP sponsor in order to submit to
the PDP sponsor the preferences
described in subclause (IV) and any
other communications relating to the
drug management program for at-risk
beneficiaries established by the PDP
sponsor; and
``(VII) contact information for
other organizations that can provide
the beneficiary with assistance
regarding such drug management program
(similar to the information provided by
the Secretary in other standardized
notices provided to part D eligible
individuals enrolled in prescription
drug plans under this part).
``(iii) Second notice.--A second notice
described in this clause is a notice that
provides to the beneficiary notice--
``(I) that the PDP sponsor has
identified the beneficiary as an at-
risk beneficiary for prescription drug
abuse;
``(II) that such beneficiary is
subject to the requirements of the drug
management program for at-risk
beneficiaries established by such PDP
sponsor for such plan;
``(III) of the prescriber (or
prescribers) and pharmacy (or
pharmacies) selected for such
individual under subparagraph (D);
``(IV) of, and information about,
the beneficiary's right to appeal such
identification under subsection (h) and
the option of an automatic escalation
to external review;
``(V) that the beneficiary can, in
the case that the beneficiary has not
previously submitted to the PDP sponsor
preferences for which prescribers and
pharmacies the beneficiary would prefer
the PDP sponsor select under
subparagraph (D), submit such
preferences to the PDP sponsor; and
``(VI) that includes clear
instructions that explain how the
beneficiary can contact the PDP
sponsor.
``(iv) Timing of notices.--
``(I) In general.--Subject to
subclause (II), a second notice
described in clause (iii) shall be
provided to the beneficiary on a date
that is not less than 60 days after an
initial notice described in clause (ii)
is provided to the beneficiary.
``(II) Exception.--In the case that
the PDP sponsor, in conjunction with
the Secretary, determines that concerns
identified through rulemaking by the
Secretary regarding the health or
safety of the beneficiary or regarding
significant drug diversion activities
require the PDP sponsor to provide a
second notice described in clause (iii)
to the beneficiary on a date that is
earlier than the date described in
subclause (I), the PDP sponsor may
provide such second notice on such
earlier date.
``(C) At-risk beneficiary for prescription drug
abuse.--
``(i) In general.--For purposes of this
paragraph, the term `at-risk beneficiary for
prescription drug abuse' means a part D
eligible individual who is not an exempted
individual described in clause (ii) and--
``(I) who is identified as such an
at-risk beneficiary through the use of
clinical guidelines developed by the
Secretary in consultation with PDP
sponsors and other stakeholders
described in section 3141(f)(2)(A) of
the 21st Century Cures Act; or
``(II) with respect to whom the PDP
sponsor of a prescription drug plan,
upon enrolling such individual in such
plan, received notice from the
Secretary that such individual was
identified under this paragraph to be
an at-risk beneficiary for prescription
drug abuse under the prescription drug
plan in which such individual was most
recently previously enrolled and such
identification has not been terminated
under subparagraph (F).
``(ii) Exempted individual described.--An
exempted individual described in this clause is
an individual who--
``(I) receives hospice care under
this title;
``(II) is a resident of a long-term
care facility, of an intermediate care
facility for the mentally retarded, or
of another facility for which
frequently abused drugs are dispensed
for residents through a contract with a
single pharmacy; or
``(III) the Secretary elects to
treat as an exempted individual for
purposes of clause (i).
``(D) Selection of prescribers and pharmacies.--
``(i) In general.--With respect to each at-
risk beneficiary for prescription drug abuse
enrolled in a prescription drug plan offered by
such sponsor, a PDP sponsor shall, based on the
preferences submitted to the PDP sponsor by the
beneficiary pursuant to clauses (ii)(IV) and
(iii)(V) of subparagraph (B) (except as
otherwise provided in this subparagraph),
select--
``(I) one or more individuals who
are authorized to prescribe frequently
abused drugs (referred to in this
paragraph as `prescribers') who may
write prescriptions for such drugs for
such beneficiary; and
``(II) one or more pharmacies that
may dispense such drugs to such
beneficiary.
``(ii) Reasonable access.--In making the
selections under this subparagraph--
``(I) a PDP sponsor shall ensure
that the beneficiary continues to have
reasonable access to frequently abused
drugs (as defined in subparagraph (G)),
taking into account geographic
location, beneficiary preference,
impact on cost-sharing, and reasonable
travel time; and
``(II) a PDP sponsor shall ensure
such access (including access to
prescribers and pharmacies with respect
to frequently abused drugs) in the case
of individuals with multiple residences
and in the case of natural disasters
and similar emergency situations.
``(iii) Beneficiary preferences.--If an at-
risk beneficiary for prescription drug abuse
submits preferences for which in-network
prescribers and pharmacies the beneficiary
would prefer the PDP sponsor select in response
to a notice under subparagraph (B), the PDP
sponsor shall--
``(I) review such preferences;
``(II) select or change the
selection of prescribers and pharmacies
for the beneficiary based on such
preferences; and
``(III) inform the beneficiary of
such selection or change of selection.
``(iv) Exception regarding beneficiary
preferences.--In the case that the PDP sponsor
determines that a change to the selection of
prescriber or pharmacy under clause (iii)(II)
by the PDP sponsor is contributing or would
contribute to prescription drug abuse or drug
diversion by the beneficiary, the PDP sponsor
may change the selection of prescriber or
pharmacy for the beneficiary without regard to
the preferences of the beneficiary described in
clause (iii).
``(v) Confirmation.--Before selecting a
prescriber (or prescribers) or pharmacy (or
pharmacies) under this subparagraph, a PDP
sponsor must request and receive confirmation
from such a prescriber or pharmacy
acknowledging and accepting that the
beneficiary involved is in the drug management
program for at-risk beneficiaries.
``(E) Terminations and appeals.--The identification
of an individual as an at-risk beneficiary for
prescription drug abuse under this paragraph, a
coverage determination made under a drug management
program for at-risk beneficiaries, and the selection of
prescriber or pharmacy under subparagraph (D) with
respect to such individual shall be subject to
reconsideration and appeal under subsection (h) and the
option of an automatic escalation to external review to
the extent provided by the Secretary.
``(F) Termination of identification.--
``(i) In general.--The Secretary shall
develop standards for the termination of
identification of an individual as an at-risk
beneficiary for prescription drug abuse under
this paragraph. Under such standards such
identification shall terminate as of the
earlier of--
``(I) the date the individual
demonstrates that the individual is no
longer likely, in the absence of the
restrictions under this paragraph, to
be an at-risk beneficiary for
prescription drug abuse described in
subparagraph (C)(i); and
``(II) the end of such maximum
period of identification as the
Secretary may specify.
``(ii) Rule of construction.--Nothing in
clause (i) shall be construed as preventing a
plan from identifying an individual as an at-
risk beneficiary for prescription drug abuse
under subparagraph (C)(i) after such
termination on the basis of additional
information on drug use occurring after the
date of notice of such termination.
``(G) Frequently abused drug.--For purposes of this
subsection, the term `frequently abused drug' means a
drug that is a controlled substance that the Secretary
determines to be frequently abused or diverted.
``(H) Data disclosure.--In the case of an at-risk
beneficiary for prescription drug abuse whose access to
coverage for frequently abused drugs under a
prescription drug plan has been limited by a PDP
sponsor under this paragraph, such PDP sponsor shall
disclose data, including any necessary individually
identifiable health information, in a form and manner
specified by the Secretary, about the decision to
impose such limitations and the limitations imposed by
the sponsor under this part to other PDP sponsors that
request such data.
``(I) Education.--The Secretary shall provide
education to enrollees in prescription drug plans of
PDP sponsors and providers regarding the drug
management program for at-risk beneficiaries described
in this paragraph, including education--
``(i) provided by Medicare administrative
contractors through the improper payment
outreach and education program described in
section 1874A(h); and
``(ii) through current education efforts
(such as State health insurance assistance
programs described in subsection (a)(1)(A) of
section 119 of the Medicare Improvements for
Patients and Providers Act of 2008 (42 U.S.C.
1395b-3 note)) and materials directed toward
such enrollees.
``(J) Application under ma-pd plans.--Pursuant to
section 1860D-21(c)(1), the provisions of this
paragraph apply under part D to MA organizations
offering MA-PD plans to MA eligible individuals in the
same manner as such provisions apply under this part to
a PDP sponsor offering a prescription drug plan to a
part D eligible individual.''.
(2) Information for consumers.--Section 1860D-4(a)(1)(B) of
the Social Security Act (42 U.S.C. 1395w-104(a)(1)(B)) is
amended by adding at the end the following:
``(v) The drug management program for at-
risk beneficiaries under subsection (c)(5).''.
(b) Utilization Management Programs.--Section 1860D-4(c) of the
Social Security Act (42 U.S.C. 1395w-104(c)), as amended by subsection
(a)(1), is further amended--
(1) in paragraph (1), by inserting after subparagraph (D)
the following new subparagraph:
``(E) A utilization management tool to prevent drug
abuse (as described in paragraph (6)(A)).''; and
(2) by adding at the end the following new paragraph:
``(6) Utilization management tool to prevent drug abuse.--
``(A) In general.--A tool described in this
paragraph is any of the following:
``(i) A utilization tool designed to
prevent the abuse of frequently abused drugs by
individuals and to prevent the diversion of
such drugs at pharmacies.
``(ii) Retrospective utilization review to
identify--
``(I) individuals that receive
frequently abused drugs at a frequency
or in amounts that are not clinically
appropriate; and
``(II) providers of services or
suppliers that may facilitate the abuse
or diversion of frequently abused drugs
by beneficiaries.
``(iii) Consultation with the contractor
described in subparagraph (B) to verify if an
individual enrolling in a prescription drug
plan offered by a PDP sponsor has been
previously identified by another PDP sponsor as
an individual described in clause (ii)(I).
``(B) Reporting.--A PDP sponsor offering a
prescription drug plan (and an MA organization offering
an MA-PD plan) in a State shall submit to the Secretary
and the Medicare drug integrity contractor with which
the Secretary has entered into a contract under section
1893 with respect to such State a report, on a monthly
basis, containing information on--
``(i) any provider of services or supplier
described in subparagraph (A)(ii)(II) that is
identified by such plan sponsor (or
organization) during the 30-day period before
such report is submitted; and
``(ii) the name and prescription records of
individuals described in paragraph (5)(C).''.
(c) Expanding Activities of Medicare Drug Integrity Contractors
(MEDICs).--
(1) In general.--Section 1893 of the Social Security Act
(42 U.S.C. 1395ddd) is amended by adding at the end the
following new subsection:
``(j) Expanding Activities of Medicare Drug Integrity Contractors
(MEDICs).--
``(1) Access to information.--Under contracts entered into
under this section with Medicare drug integrity contractors
(including any successor entity to a Medicare drug integrity
contractor), the Secretary shall authorize such contractors to
directly accept prescription and necessary medical records from
entities such as pharmacies, prescription drug plans, MA-PD
plans, and physicians with respect to an individual in order
for such contractors to provide information relevant to the
determination of whether such individual is an at-risk
beneficiary for prescription drug abuse, as defined in section
1860D-4(c)(5)(C).
``(2) Requirement for acknowledgment of referrals.--If a
PDP sponsor or MA organization refers information to a
contractor described in paragraph (1) in order for such
contractor to assist in the determination described in such
paragraph, the contractor shall--
``(A) acknowledge to the sponsor or organization
receipt of the referral; and
``(B) in the case that any PDP sponsor or MA
organization contacts the contractor requesting to know
the determination by the contractor of whether or not
an individual has been determined to be an individual
described such paragraph, shall inform such sponsor or
organization of such determination on a date that is
not later than 15 days after the date on which the
sponsor or organization contacts the contractor.
``(3) Making data available to other entities.--
``(A) In general.--For purposes of carrying out
this subsection, subject to subparagraph (B), the
Secretary shall authorize MEDICs to respond to requests
for information from PDP sponsors and MA organizations,
State prescription drug monitoring programs, and other
entities delegated by such sponsors or organizations
using available programs and systems in the effort to
prevent fraud, waste, and abuse.
``(B) HIPAA compliant information only.--
Information may only be disclosed by a MEDIC under
subparagraph (A) if the disclosure of such information
is permitted under the Federal regulations (concerning
the privacy of individually identifiable health
information) promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note).''.
(2) OIG study and report on effectiveness of medics.--
(A) Study.--The Inspector General of the Department
of Health and Human Services shall conduct a study on
the effectiveness of Medicare drug integrity
contractors with which the Secretary of Health and
Human Services has entered into a contract under
section 1893 of the Social Security Act (42 U.S.C.
1395ddd) in identifying, combating, and preventing
fraud under the Medicare Program, including under the
authority provided under section 1893(j) of the Social
Security Act, added by paragraph (1).
(B) Report.--Not later than 1 year after the date
of the enactment of this Act, the Inspector General
shall submit to Congress a report on the study
conducted under subparagraph (A). Such report shall
include such recommendations for improvements in the
effectiveness of such contractors as the Inspector
General determines appropriate.
(d) Treatment of Certain Complaints for Purposes of Quality or
Performance Assessment.--Section 1860D-42 of the Social Security Act
(42 U.S.C. 1395w-152) is amended by adding at the end the following new
subsection:
``(d) Treatment of Certain Complaints for Purposes of Quality or
Performance Assessment.--In conducting a quality or performance
assessment of a PDP sponsor, the Secretary shall develop or utilize
existing screening methods for reviewing and considering complaints
that are received from enrollees in a prescription drug plan offered by
such PDP sponsor and that are complaints regarding the lack of access
by the individual to prescription drugs due to a drug management
program for at-risk beneficiaries.''.
(e) Sense of Congress Regarding Use of Technology Tools To Combat
Fraud.--It is the sense of Congress that MA organizations and PDP
sponsors should consider using e-prescribing and other health
information technology tools to support combating fraud under MA-PD
plans and prescription drug plans under parts C and D of the Medicare
Program.
(f) Effective Date.--
(1) In general.--The amendments made by this section shall
apply to prescription drug plans (and MA-PD plans) for plan
years beginning more than 1 year after the date of the
enactment of this Act.
(2) Stakeholder meetings prior to effective date.--
(A) In general.--Not later than January 1, 2016,
the Secretary of Health and Human Services shall
convene stakeholders, including individuals entitled to
benefits under part A of title XVIII of the Social
Security Act or enrolled under part B of such title of
such Act, advocacy groups representing such
individuals, physicians, pharmacists, and other
clinicians, retail pharmacies, plan sponsors, entities
delegated by plan sponsors, and biopharmaceutical
manufacturers for input regarding the topics described
in subparagraph (B).
(B) Topics described.--The topics described in this
subparagraph are the topics of--
(i) the anticipated impact of drug
management programs for at-risk beneficiaries
under paragraph (5) of section 1860D-4(c) of
the Social Security Act (42 U.S.C. 1395w-
104(c)) on cost-sharing and ensuring
accessibility to prescription drugs for
enrollees in prescription drug plans of PDP
sponsors, and enrollees in MA-PD plans, who are
at-risk beneficiaries for prescription drug
abuse (as defined in subparagraph (C) of such
paragraph);
(ii) the use of an expedited appeals
process under which such an enrollee may appeal
an identification of such enrollee as an at-
risk beneficiary for prescription drug abuse
under such paragraph (similar to the processes
established under the Medicare Advantage
program under part C of title XVIII of the
Social Security Act that allow an automatic
escalation to external review of claims
submitted under such part);
(iii) the types of enrollees that should be
treated as exempted individuals, as described
in subparagraph (C)(ii) of such paragraph;
(iv) the manner in which terms and
definitions in such paragraph should be
applied, such as the use of clinical
appropriateness in determining whether an
enrollee is an at-risk beneficiary for
prescription drug abuse as defined in
subparagraph (C) of such paragraph;
(v) the information to be included in the
notices described in subparagraph (B) of such
paragraph and the standardization of such
notices; and
(vi) with respect to a PDP sponsor (or
Medicare Advantage organization) that
establishes a drug management program for at-
risk beneficiaries under such paragraph, the
responsibilities of such PDP sponsor (or
organization) with respect to the
implementation of such program.
(g) Rulemaking.--The Secretary of Health and Human Services shall
promulgate regulations based on the input gathered pursuant to
subsection (f)(2)(A).
SEC. 502. EXCLUSION OF AUTHORIZED GENERIC DRUGS FROM CALCULATION OF
AVERAGE MANUFACTURER PRICE FOR BRAND NAME DRUGS.
(a) In General.--Section 1927(k)(1)(C) of the Social Security Act
(42 U.S.C. 1396r-8(k)(1)(C)) is amended--
(1) in the subparagraph heading, by striking ``Inclusion''
and inserting ``Exclusion'';
(2) by striking ``a new drug application'' and inserting
``the manufacturer's new drug application''; and
(3) by striking ``inclusive'' and inserting ``exclusive''.
(b) Effective Date.--The amendments made by subsection (a) shall
take effect one year after the date of the enactment of this section.
<all>