[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 6
To provide for opioid use disorder prevention, recovery, and treatment,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 13, 2018
Mr. Walden (for himself, Mr. Pallone, Mr. Brady of Texas, Mr. Neal, Mr.
Roe of Tennessee, Mr. Shuster, Ms. Foxx, Mr. Goodlatte, Mr. Walz, Mr.
DeFazio, and Mr. Burgess) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committees on Ways and Means, and the Judiciary, 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 provide for opioid use disorder prevention, recovery, and treatment,
and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities Act'' or the ``SUPPORT for Patients and
Communities Act''.
(b) Table of Contents.--The table of contents for the Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 101. At-risk youth Medicaid protection.
Sec. 102. Health Insurance for Former Foster Youth.
Sec. 103. Demonstration project to increase substance use provider
capacity under the Medicaid program.
Sec. 104. Drug management program for at-risk beneficiaries.
Sec. 105. Medicaid drug review and utilization.
Sec. 106. Guidance to improve care for infants with neonatal abstinence
syndrome and their mothers; GAO study on
gaps in Medicaid coverage for pregnant and
postpartum women with substance use
disorder.
Sec. 107. Medicaid health homes for opioid-use-disorder Medicaid
enrollees.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 201. Authority not to apply certain Medicare telehealth
requirements in the case of certain
treatment of a substance use disorder or
co-occurring mental health disorder.
Sec. 202. Encouraging the use of non-opioid analgesics for the
management of post-surgical pain.
Sec. 203. Requiring a review of current opioid prescriptions for
chronic pain and screening for opioid use
disorder to be included in the Welcome to
Medicare initial preventive physical
examination.
Sec. 204. Modification of payment for certain outpatient surgical
services.
Sec. 205. Requiring e-prescribing for coverage of covered part D
controlled substances.
Sec. 206. Requiring prescription drug plan sponsors under Medicare to
establish drug management programs for at-
risk beneficiaries.
Sec. 207. Medicare coverage of certain services furnished by opioid
treatment programs.
TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 301. Clarifying FDA regulation of non-addictive pain and addiction
therapies.
Sec. 302. Surveillance and Testing of Opioids to Prevent Fentanyl
Deaths.
Sec. 303. Allowing for more flexibility with respect to medication-
assisted treatment for opioid use
disorders.
TITLE IV--OFFSETS
Sec. 401. Promoting value in Medicaid managed care.
Sec. 402. Extending period of application of Medicare secondary payer
rules for individuals with end stage renal
disease.
Sec. 403. Requiring reporting by group health plans of prescription
drug coverage information for purposes of
identifying primary payer situations under
the Medicare program.
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 101. AT-RISK YOUTH MEDICAID PROTECTION.
(a) In General.--Section 1902 of the Social Security Act (42 U.S.C.
1396a) is amended--
(1) in subsection (a)--
(A) by striking ``and'' at the end of paragraph
(82);
(B) by striking the period at the end of paragraph
(83) and inserting ``; and''; and
(C) by inserting after paragraph (83) the following
new paragraph:
``(84) provide that--
``(A) the State shall not terminate eligibility for
medical assistance under the State plan for an
individual who is an eligible juvenile (as defined in
subsection (nn)(2)) because the juvenile is an inmate
of a public institution (as defined in subsection
(nn)(3)), but may suspend coverage during the period
the juvenile is such an inmate;
``(B) in the case of an individual who is an
eligible juvenile described in paragraph (2)(A) of
subsection (nn), the State shall, prior to the
individual's release from such a public institution,
conduct a redetermination of eligibility for such
individual with respect to such medical assistance
(without requiring a new application from the
individual) and, if the State determines pursuant to
such redetermination that the individual continues to
meet the eligibility requirements for such medical
assistance, the State shall restore coverage for such
medical assistance to such an individual upon the
individual's release from such public institution; and
``(C) in the case of an individual who is an
eligible juvenile described in paragraph (2)(B) of
subsection (nn), the State shall process any
application for medical assistance submitted by, or on
behalf of, such individual such that the State makes a
determination of eligibility for such individual with
respect to such medical assistance upon release of such
individual from such public institution.''; and
(2) by adding at the end the following new subsection:
``(nn) Juvenile; Eligible Juvenile; Public Institution.--For
purposes of subsection (a)(84) and this subsection:
``(1) Juvenile.--The term `juvenile' means an individual
who is--
``(A) under 21 years of age; or
``(B) described in subsection (a)(10)(A)(i)(IX).
``(2) Eligible juvenile.--The term `eligible juvenile'
means a juvenile who is an inmate of a public institution and
who--
``(A) was determined eligible for medical
assistance under the State plan immediately before
becoming an inmate of such a public institution; or
``(B) is determined eligible for such medical
assistance while an inmate of a public institution.
``(3) Inmate of a public institution.--The term `inmate of
a public institution' has the meaning given such term for
purposes of applying the subdivision (A) following paragraph
(29) of section 1905(a), taking into account the exception in
such subdivision for a patient of a medical institution.''.
(b) No Change in Exclusion From Medical Assistance for Inmates of
Public Institutions.--Nothing in this section shall be construed as
changing the exclusion from medical assistance under the subdivision
(A) following paragraph (29) of section 1905(a) of the Social Security
Act (42 U.S.C. 1396d(a)), including any applicable restrictions on a
State submitting claims for Federal financial participation under title
XIX of such Act for such assistance.
(c) No Change in Continuity of Eligibility Before Adjudication or
Sentencing.--Nothing in this section shall be construed to mandate,
encourage, or suggest that a State suspend or terminate coverage for
individuals before they have been adjudicated or sentenced.
(d) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by subsection (a) shall apply to eligibility of
juveniles who become inmates of public institutions on or after
the date that is 1 year after the date of the enactment of this
Act.
(2) Rule for changes requiring state legislation.--In the
case of a State plan for medical assistance under title XIX of
the Social Security Act which the Secretary of Health and Human
Services determines requires State legislation (other than
legislation appropriating funds) in order for the plan to meet
the additional requirements imposed by the amendments made by
subsection (a), the State plan shall not be regarded as failing
to comply with the requirements of such title solely on the
basis of its failure to meet these additional requirements
before the first day of the first calendar quarter beginning
after the close of the first regular session of the State
legislature that begins after the date of the enactment of this
Act. For purposes of the previous sentence, in the case of a
State that has a 2-year legislative session, each year of such
session shall be deemed to be a separate regular session of the
State legislature.
SEC. 102. HEALTH INSURANCE FOR FORMER FOSTER YOUTH.
(a) Coverage Continuity for Former Foster Care Children up to Age
26.--
(1) In general.--Section 1902(a)(10)(A)(i)(IX) of the
Social Security Act (42 U.S.C. 1396a(a)(10)(A)(i)(IX)) is
amended--
(A) in item (bb), by striking ``are not described
in or enrolled under'' and inserting ``are not
described in and are not enrolled under'';
(B) in item (cc), by striking ``responsibility of
the State'' and inserting ``responsibility of a
State''; and
(C) in item (dd), by striking ``the State plan
under this title or under a waiver of the'' and
inserting ``a State plan under this title or under a
waiver of such a''.
(2) Effective date.--The amendments made by this subsection
shall take effect with respect to foster youth who attain 18
years of age on or after January 1, 2023.
(b) Guidance.--Not later than one year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
issue guidance to States, with respect to the State Medicaid programs
of such States--
(1) on best practices for--
(A) removing barriers and ensuring streamlined,
timely access to Medicaid coverage for former foster
youth up to age 26; and
(B) conducting outreach and raising awareness among
such youth regarding Medicaid coverage options for such
youth; and
(2) which shall include examples of States that have
successfully extended Medicaid coverage to former foster youth
up to age 26.
SEC. 103. DEMONSTRATION PROJECT TO INCREASE SUBSTANCE USE PROVIDER
CAPACITY UNDER THE MEDICAID PROGRAM.
Section 1903 of the Social Security Act (42 U.S.C. 1396b) is
amended by adding at the end the following new subsection:
``(aa) Demonstration Project To Increase Substance Use Provider
Capacity.--
``(1) In general.--Not later than the date that is 180 days
after the date of the enactment of this section, the Secretary
shall, in consultation, as appropriate, with the Director of
the Agency for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and Substance Use,
conduct a 54-month demonstration project for the purpose
described in paragraph (2) under which the Secretary shall--
``(A) for the first 18-month period of such
project, award planning grants described in paragraph
(3); and
``(B) for the remaining 36-month period of such
project, provide to each State selected under paragraph
(4) payments in accordance with paragraph (5).
``(2) Purpose.--The purpose described in this paragraph is
for each State selected under paragraph (4) to increase the
treatment capacity of providers participating under the State
plan (or a waiver of such plan) to provide substance use
disorder treatment or recovery services under such plan (or
waiver) through the following activities:
``(A) For the purpose described in paragraph
(3)(C)(i), activities that support an ongoing
assessment of the behavioral health treatment needs of
the State, taking into account the matters described in
subclauses (I) through (IV) of such paragraph.
``(B) Activities that, taking into account the
results of the assessment described in subparagraph
(A), support the recruitment, training, and provision
of technical assistance for providers participating
under the State plan (or a waiver of such plan) that
offer substance use disorder treatment or recovery
services.
``(C) Improved reimbursement for and expansion of,
through the provision of education, training, and
technical assistance, the number or treatment capacity
of providers participating under the State plan (or
waiver) that--
``(i) are authorized to dispense drugs
approved by the Food and Drug Administration
for individuals with a substance use disorder
who need withdrawal management or maintenance
treatment for such disorder;
``(ii) have in effect a registration or
waiver under section 303(g) of the Controlled
Substances Act for purposes of dispensing
narcotic drugs to individuals for maintenance
treatment or detoxification treatment and are
in compliance with any regulation promulgated
by the Assistant Secretary for Mental Health
and Substance Use for purposes of carrying out
the requirements of such section 303(g); and
``(iii) are qualified under applicable
State law to provide substance use disorder
treatment or recovery services.
``(D) Improved reimbursement for and expansion of,
through the provision of education, training, and
technical assistance, the number or treatment capacity
of providers participating under the State plan (or
waiver) that have the qualifications to address the
treatment or recovery needs of--
``(i) individuals enrolled under the State
plan (or a waiver of such plan) who have
neonatal abstinence syndrome, in accordance
with guidelines issued by the American Academy
of Pediatrics and American College of
Obstetricians and Gynecologists relating to
maternal care and infant care with respect to
neonatal abstinence syndrome;
``(ii) pregnant women, postpartum women,
and infants, particularly the concurrent
treatment, as appropriate, and comprehensive
case management of pregnant women, postpartum
women and infants, enrolled under the State
plan (or a waiver of such plan);
``(iii) adolescents and young adults
between the ages of 12 and 21 enrolled under
the State plan (or a waiver of such plan); or
``(iv) American Indian and Alaska Native
individuals enrolled under the State plan (or a
waiver of such plan).
``(3) Planning grants.--
``(A) In general.--The Secretary shall, with
respect to the first 18-month period of the
demonstration project conducted under paragraph (1),
award planning grants to at least 10 States selected in
accordance with subparagraph (B) for purposes of
preparing an application described in paragraph (4)(C)
and carrying out the activities described in
subparagraph (C).
``(B) Selection.--In selecting States for purposes
of this paragraph, the Secretary shall--
``(i) select States that have a State plan
(or waiver of the State plan) approved under
this title;
``(ii) select States in a manner that
ensures geographic diversity; and
``(iii) give preference to States with a
prevalence of substance use disorders (in
particular opioid use disorders) that is
comparable to or higher than the national
average prevalence, as measured by aggregate
per capita drug overdoses, or any other measure
that the Secretary deems appropriate.
``(C) Activities described.--Activities described
in this subparagraph are, with respect to a State, each
of the following:
``(i) Activities that support the
development of an initial assessment of the
behavioral health treatment needs of the State
to determine the extent to which providers are
needed (including the types of such providers
and geographic area of need) to improve the
network of providers that treat substance use
disorders under the State plan (or waiver),
including the following:
``(I) An estimate of the number of
individuals enrolled under the State
plan (or a waiver of such plan) who
have a substance use disorder.
``(II) Information on the capacity
of providers to provide substance use
disorder treatment or recovery services
to individuals enrolled under the State
plan (or waiver), including information
on providers who provide such services
and their participation under the State
plan (or waiver).
``(III) Information on the gap in
substance use disorder treatment or
recovery services under the State plan
(or waiver) based on the information
described in subclauses (I) and (II).
``(IV) Projections regarding the
extent to which the State participating
under the demonstration project would
increase the number of providers
offering substance use disorder
treatment or recovery services under
the State plan (or waiver) during the
period of the demonstration project.
``(ii) Activities that, taking into account
the results of the assessment described in
clause (i), support the development of State
infrastructure to, with respect to the
provision of substance use disorder treatment
or recovery services under the State plan (or a
waiver of such plan), recruit prospective
providers and provide training and technical
assistance to such providers.
``(D) Funding.--For purposes of subparagraph (A),
there is appropriated, out of any funds in the Treasury
not otherwise appropriated, $50,000,000, to remain
available until expended.
``(4) Post-planning states.--
``(A) In general.--The Secretary shall, with
respect to the remaining 36-month period of the
demonstration project conducted under paragraph (1),
select not more than 5 States in accordance with
subparagraph (B) for purposes of carrying out the
activities described in paragraph (2) and receiving
payments in accordance with paragraph (5).
``(B) Selection.--In selecting States for purposes
of this paragraph, the Secretary shall--
``(i) select States that received a
planning grant under paragraph (3);
``(ii) select States that submit to the
Secretary an application in accordance with the
requirements in subparagraph (C), taking into
consideration the quality of each such
application;
``(iii) select States in a manner that
ensures geographic diversity; and
``(iv) give preference to States with a
prevalence of substance use disorders (in
particular opioid use disorders) that is
comparable to or higher than the national
average prevalence, as measured by aggregate
per capita drug overdoses, or any other measure
that the Secretary deems appropriate.
``(C) Applications.--
``(i) In general.--A State seeking to be
selected for purposes of this paragraph shall
submit to the Secretary, at such time and in
such form and manner as the Secretary requires,
an application that includes such information,
provisions, and assurances, as the Secretary
may require, in addition to the following:
``(I) A proposed process for
carrying out the ongoing assessment
described in paragraph (2)(A), taking
into account the results of the initial
assessment described in paragraph
(3)(C)(i).
``(II) A review of reimbursement
methodologies and other policies
related to substance use disorder
treatment or recovery services under
the State plan (or waiver) that may
create barriers to increasing the
number of providers delivering such
services.
``(III) The development of a plan,
taking into account activities carried
out under paragraph (3)(C)(ii), that
will result in long-term and
sustainable provider networks under the
State plan (or waiver) that will offer
a continuum of care for substance use
disorders. Such plan shall include the
following:
``(aa) Specific activities
to increase the number of
providers (including providers
that specialize in providing
substance use disorder
treatment or recovery services,
hospitals, health care systems,
Federally qualified health
centers, and, as applicable,
certified community behavioral
health clinics) that offer
substance use disorder
treatment, recovery, or support
services, including short-term
detoxification services,
outpatient substance use
disorder services, and
evidence-based peer recovery
services.
``(bb) Strategies that will
incentivize providers described
in subparagraphs (C) and (D) of
paragraph (2) to obtain the
necessary training, education,
and support to deliver
substance use disorder
treatment or recovery services
in the State.
``(cc) Milestones and
timeliness for implementing
activities set forth in the
plan.
``(dd) Specific measurable
targets for increasing the
substance use disorder
treatment and recovery provider
network under the State plan
(or a waiver of such plan).
``(IV) A proposed process for
reporting the information required
under paragraph (6)(A), including
information to assess the effectiveness
of the efforts of the State to expand
the capacity of providers to deliver
substance use disorder treatment or
recovery services during the period of
the demonstration project under this
subsection.
``(V) The expected financial impact
of the demonstration project under this
subsection on the State.
``(VI) A description of all funding
sources available to the State to
provide substance use disorder
treatment or recovery services in the
State.
``(VII) A preliminary plan for how
the State will sustain any increase in
the capacity of providers to deliver
substance use disorder treatment or
recovery services resulting from the
demonstration project under this
subsection after the termination of
such demonstration project.
``(VIII) A description of how the
State will coordinate the goals of the
demonstration project with any waiver
granted (or submitted by the State and
pending) pursuant to section 1115 for
the delivery of substance use services
under the State plan, as applicable.
``(ii) Consultation.--In completing an
application under clause (i), a State shall
consult with relevant stakeholders, including
Medicaid managed care plans, health care
providers, and Medicaid beneficiary advocates,
and include in such application a description
of such consultation.
``(5) Payment.--
``(A) In general.--For each quarter occurring
during the period for which the demonstration project
is conducted (after the first 18 months of such
period), the Secretary shall pay under this subsection,
subject to subparagraph (C), to each State selected
under paragraph (4) an amount equal to 80 percent of so
much of the qualified sums expended during such
quarter.
``(B) Qualified sums defined.--For purposes of
subparagraph (A), the term `qualified sums' means, with
respect to a State and a quarter, the amount equal to
the amount (if any) by which the sums expended by the
State during such quarter attributable to substance use
treatment or recovery services furnished by providers
participating under the State plan (or a waiver of such
plan) exceeds \1/4\ of such sums expended by the State
during fiscal year 2018 attributable to substance use
treatment or recovery services.
``(C) Non-duplication of payment.--In the case that
payment is made under subparagraph (A) with respect to
expenditures for substance use treatment or recovery
services furnished by providers participating under the
State plan (or a waiver of such plan), payment may not
also be made under subsection (a) with respect to
expenditures for the same services so furnished.
``(6) Reports.--
``(A) State reports.--A State receiving payments
under paragraph (5) shall, for the period of the
demonstration project under this subsection, submit to
the Secretary a quarterly report, with respect to
expenditures for substance use treatment or recovery
services for which payment is made to the State under
this subsection, on the following:
``(i) The specific activities with respect
to which payment under this subsection was
provided.
``(ii) The number of providers that
delivered substance use disorder treatment or
recovery services in the State under the
demonstration project compared to the estimated
number of providers that would have otherwise
delivered such services in the absence of such
demonstration project.
``(iii) The number of individuals enrolled
under the State plan (or a waiver of such plan)
who received substance use disorder treatment
or recovery services under the demonstration
project compared to the estimated number of
such individuals who would have otherwise
received such services in the absence of such
demonstration project.
``(iv) Other matters as determined by the
Secretary.
``(B) CMS reports.--
``(i) Initial report.--Not later than
October 1, 2020, the Administrator of the
Centers for Medicare & Medicaid Services shall,
in consultation with the Director of the Agency
for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and
Substance Use, submit to Congress an initial
report on--
``(I) the States awarded planning
grants under paragraph (3);
``(II) the criteria used in such
selection; and
``(III) the activities carried out
by such States under such planning
grants.
``(ii) Interim report.--Not later than
October 1, 2022, the Administrator of the
Centers for Medicare & Medicaid Services shall,
in consultation with the Director of the Agency
for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and
Substance Use, submit to Congress an interim
report--
``(I) on activities carried out
under the demonstration project under
this subsection;
``(II) on the extent to which
States selected under paragraph (4)
have achieved the stated goals
submitted in their applications under
subparagraph (C) of such paragraph;
``(III) with a description of the
strengths and limitations of such
demonstration project; and
``(IV) with a plan for the
sustainability of such project.
``(iii) Final report.--Not later than
October 1, 2024, the Administrator of the
Centers for Medicare & Medicaid Services shall,
in consultation with the Director of the Agency
for Healthcare Research and Quality and the
Assistant Secretary for Mental Health and
Substance Use, submit to Congress a final
report--
``(I) providing updates on the
matters reported in the interim report
under clause (ii);
``(II) including a description of
any changes made with respect to the
demonstration project under this
subsection after the submission of such
interim report; and
``(III) evaluating such
demonstration project.
``(C) AHRQ report.--Not later than three years
after the date of the enactment of this subsection, the
Director of the Agency for Healthcare Research and
Quality, on consultation with the Administrator of the
Centers for Medicare & Medicaid Services, shall submit
to Congress a summary on the experiences of States
awarded planning grants under paragraph (3) and States
selected under paragraph (4).
``(7) Data sharing and best practices.--During the period
of the demonstration project under this subsection, the
Secretary shall, in collaboration with States selected under
paragraph (4), facilitate data sharing and the development of
best practices between such States and States that were not so
selected.
``(8) CMS funding.--There is appropriated, out of any funds
in the Treasury not otherwise appropriated, $5,000,000 to the
Centers for Medicare & Medicaid Services for purposes of
implementing this subsection. Such amount shall remain
available until expended.''.
SEC. 104. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.
(a) In General.--Title XIX of the Social Security Act is amended by
inserting after section 1927 (42 U.S.C. 1396r-8) the following new
section:
``SEC. 1927A. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.
``(a) In General.--Beginning January 1, 2020, a State shall operate
a qualified drug management program under which a State may enroll
certain at-risk beneficiaries identified by the State under the
program.
``(b) Qualified Drug Management Program.--For purposes of this
section, the term `qualified drug management program' means, with
respect to a State, a program carried out by the State (including
through a contract with a pharmacy benefit manager) that provides at
least for the following:
``(1) Identification of at-risk individuals.--Under the
program, the State identifies, in accordance with subsection
(c), individuals enrolled under the State plan (or waiver of
the State plan) who are at-risk beneficiaries.
``(2) Elements of program.--
``(A) In general.--Under the program, the State,
with respect to each individual identified under
paragraph (1) and enrolled under the program under
paragraph (5)--
``(i) subject to subparagraphs (B) and (C),
selects at least one, but not more than three,
health care providers and at least one, but not
more than three, pharmacies for each such
individual for purposes of clause (ii), in
accordance with a selection process that takes
into account reasonable factors such as the
individual's previous utilization of items and
services from health care providers and
pharmacies, geographic proximity of the
individual to such health care providers and
pharmacies, access of the individual to health
care, reasonable travel time, information
regarding housing status, and any known
preference of the individual for a certain
health care provider or pharmacy; and
``(ii) requires that any controlled
substance furnished to such individual during
the period for which such individual is
enrolled under the program be prescribed by a
health care provider selected under clause (i)
for such individual and dispensed by a pharmacy
selected under clause (i) for such individual
in order for such controlled substance to be
covered under the State plan (or waiver).
``(B) Beneficiary preference.--In the case of an
individual receiving a notice under paragraph (3)(A) of
being identified as potentially being an at-risk
beneficiary described in such paragraph, such
individual may submit, during the 30-day period
following receipt of such notice, preferences for which
health care providers and pharmacies the individual
would prefer the State to select under subparagraph
(A). The State shall select or change the selection of
health care providers and pharmacies under subparagraph
(A) for the individuals based on such preferences,
except that in the case that State determines that such
selection (or change of selection) of a health care
provider or pharmacy under subparagraph (A) is
contributing or would contribute to prescription drug
abuse or drug diversion by the individual, the State
may select or change the selection of health care
provider or pharmacy for the individual without regard
to the preferences of the individual described in this
subparagraph. If the State selects or changes the
selection pursuant to the preceding sentence without
regard to the preferences of the individual, the State
shall provide the individual with at least 30 days
written notice of the selection or change of selection
and a rationale for the selection or change.
``(C) Treatment of pharmacy with multiple
locations.--For purposes of subparagraph (A)(i), in the
case of a pharmacy that has multiple locations that
share real-time electronic prescription data, all such
locations of the pharmacy shall collectively be treated
as one pharmacy.
``(D) Treatment of existing ffs drug management
programs.--In the case of a patient review and
restriction program (as identified in the annual report
submitted to the Secretary under section 1927(g)(3)(D))
operated by a State pursuant to section 1915(a)(2)
before the date of the enactment of this section, such
program shall be treated as a qualified drug management
program.
``(E) Reasonable access.--The program shall ensure,
including through waiver of elements of the program
(including under subparagraph (A)(ii)), reasonable
access to health care (including access to health care
providers and pharmacies with respect to prescription
drugs described in subparagraph (A)) in the case of
individuals with multiple residences, in the case of
natural disasters and similar situations, and in the
case of the provision of emergency services (as defined
for purposes of section 1860D-4(c)(5)(D)(ii)(II)).
``(3) Notification to identified individuals.--Under the
program, the State provides each individual who is identified
under paragraph (1), prior to enrolling such individual under
the program, at least one notification of each of the
following:
``(A) Notice that the State has identified the
individual as potentially being an at-risk beneficiary
for abuse or misuse of a controlled substance.
``(B) The name, address, and contact information of
each health care provider and pharmacy that may be
selected for the individual under paragraph (2)(A).
``(C) Information describing all State and Federal
public health resources that are designed to address
such abuse or misuse to which the individual has
access, including mental health services, substance use
disorder and recovery services, and other counseling
services.
``(D) Notice of, and information about, the right
of the individual to--
``(i) submit preferences of the individual
for health care providers and pharmacies to be
selected under paragraph (2)(A), including as
described in paragraph (2)(B);
``(ii) appeal under paragraph (4)--
``(I) such identification described
in subparagraph (A); and
``(II) the selection of health care
providers and pharmacies under
paragraph (2)(A).
``(E) An explanation of the meaning and
consequences of the identification of the individual as
potentially being an at-risk beneficiary for abuse or
misuse of a controlled substance, including an
explanation of the program.
``(F) Information, including a contact list and
clear instructions, that explain how the individual can
contact the appropriate entities administering the
program in order to submit preferences described in
paragraph (2)(B) and any other communications relating
to the program.
``(4) Appeals process.--Under the program, the State
provides for an appeals process under which, with respect to an
individual identified under paragraph (1)--
``(A) such individual may appeal--
``(i) such identification; and
``(ii) the selection of a health care
provider or pharmacy under paragraph (2)(A);
``(B) in the case of an appeal described in
subparagraph (A)(ii), the State shall accommodate the
health care provider or pharmacy preferred by the
individual for selection for purposes of paragraph
(2)(A), unless the State determines that a change to
the selection of health care provider or pharmacy under
such paragraph is contributing or would contribute to
prescription drug abuse or drug diversion by the
individual;
``(C) such individual is provided a period of not
less than 30 days following the date of receipt of the
notice described in paragraph (3) to submit such
appeal; and
``(D) the State must make a determination with
respect to an appeal described in subparagraph (A), and
notify the individual of such determination, prior to
enrollment of such individual in the program.
``(5) Enrollment.--Under the program, the State initially
enrolls individuals who are identified under paragraph (1) in
the program for a 12-month period--
``(A) in the case of such an individual who does
not submit an appeal under paragraph (4) within the
period applied by the State pursuant to subparagraph
(C) of such paragraph, beginning on the day after the
last day of such period; and
``(B) in the case of such an individual who does
submit an appeal under paragraph (4) within the period
applied by the State pursuant to subparagraph (C) of
such paragraph but such appeal is denied, beginning not
later than 30 days after the date of such denial.
``(6) Notification of health care providers and
pharmacies.--Under the program, the State provides to each
health care provider and pharmacy selected for an individual
under paragraph (2)--
``(A) notification that the individual is an at-
risk beneficiary enrolled under the program and that
the provider or pharmacy has been selected for the
individual under paragraph (2);
``(B) information on such program and the role of
being so selected; and
``(C) a process through which the provider or
pharmacy can submit a concern or complaint with respect
to being so selected.
``(7) Continuation of enrollment.--Under the program, the
State, with respect to an individual enrolled under the
program, provides for a process to--
``(A) not later than 30 days before the end of the
12-month period for which the individual is so enrolled
pursuant to paragraph (5)--
``(i) assess, in accordance with publicly
available evidence-based guidelines, whether or
not such individual should continue to be
enrolled under the program; and
``(ii) notify such individual of the
results of the assessment under clause (i);
``(B) continue, subject to subparagraph (C),
enrollment of such individual if such assessment
recommends such continuation; and
``(C) appeal the continuation of enrollment in
accordance with the appeals process described in
paragraph (4).
``(c) At-Risk Beneficiary.--
``(1) Identification.--For purposes of this section, a
State shall identify an individual enrolled under the State
plan (or waiver of the State plan) as an at-risk beneficiary if
the individual is not an exempted individual described in
paragraph (2) and--
``(A) is identified as such an at-risk beneficiary
through the use of publicly available evidence-based
guidelines that indicate misuse or abuse of a
controlled substance; or
``(B) the State received notification from a PDP
sponsor or Medicare Advantage organization that such
individual was identified as being an at-risk
beneficiary for prescription drug abuse for enrollment
in a drug management program established by the sponsor
or organization pursuant to section 1860D-4(c)(5) and
such identification has not been terminated under
subparagraph (F) of such section.
``(2) Exempted individual described.--For purposes of
paragraph (1), an exempted individual described in this
paragraph is an individual who--
``(A) is receiving--
``(i) hospice or palliative care; or
``(ii) treatment for cancer;
``(B) is a resident of a long-term care facility,
of a facility described in section 1905(d), or of
another facility for which frequently abused drugs are
dispensed for residents through a contract with a
single pharmacy; or
``(C) the State elects to treat as an exempted
individual for purposes of paragraph (1).
``(d) Application of Privacy Rules Clarification.--The Secretary
shall clarify privacy requirements, including requirements under the
regulations promulgated pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note), related to the sharing of data under subsection (b)(6) in the
same manner as the Secretary is required under subparagraph (J) of
section 1860D-4(c)(5) to clarify privacy requirements related to the
sharing of data described in such subparagraph.
``(e) Reports.--
``(1) Annual reports.--A State operating a qualified drug
management program shall include in the annual report submitted
to the Secretary under section 1927(g)(3)(D), beginning with
such reports submitted for 2021, the following information:
``(A) The number of individuals enrolled under the
State plan (or waiver of the State plan) who are
enrolled under the program and the percentage of
individuals enrolled under the State plan (or waiver)
who are enrolled under such program.
``(B) The number of prescriptions for controlled
substances that were dispensed per month during each
such year per individual enrolled under the program,
including the daily morphine milligram equivalents and
the quantity prescribed for each such prescription.
``(C) The number of pharmacies filling
prescriptions for controlled substances for individuals
enrolled under such program.
``(D) The number of health care providers writing
prescriptions for controlled substances (other than
prescriptions for a refill) for individuals enrolled
under such program.
``(E) Any other data that the Secretary may
require.
``(F) Any report submitted by a managed care entity
under subsection (f)(1)(B) with respect to the year
involved.
For each such report for a year after 2021, the information
described in this paragraph shall be provided in a manner that
compares such information with respect to the prior calendar
year to such information with respect to the second prior
calendar year.
``(2) MACPAC reports and review.--Not later than two years
after the date of the enactment of this section, the Medicaid
and CHIP Payment and Access Commission (in this section
referred to as `MACPAC'), in consultation with the National
Association of Medicaid Directors, pharmacy benefit managers,
managed care organizations, health care providers (including
pharmacists), beneficiary advocates, and other stakeholders,
shall publish a report that includes--
``(A) best practices for operating drug management
programs, based on a review of a representative sample
of States administering such a program;
``(B) a summary of the experience of the appeals
process under drug management programs operated by
several States, such as the frequency at which
individuals appealed the identification of being an at-
risk individual, the frequency at which individuals
appealed the selection of a health care provider or
pharmacy under such a program, the timeframes for such
appeals, a summary of the reasons for such appeals, and
the design of such appeals processes;
``(C) a summary of trends and the effectiveness of
qualified drug management programs operated under this
section; and
``(D) recommendations to States on how improvements
can be made with respect to the operation of such
programs.
In reporting on State practices, the MACPAC shall consider how
such programs have been implemented in rural areas, under fee-
for-service as well as managed care arrangements, and the
extent to which such programs have resulted in increased
efficiencies to such States or to the Federal Government under
this title.
``(3) Report on plan for coordinated care.--Not later than
January 1, 2021, each State operating a qualified drug
management program shall submit to the Administrator of the
Centers for Medicare & Medicaid Services a report on how such
State plans to provide coordinated care for individuals
enrolled under the State plan (or waiver of the State plan)
and--
``(A) who are enrolled under the program; or
``(B) who are enrolled with a managed care entity
and enrolled under such a qualified drug management
program operated by such entity.
``(f) Applicability to Managed Care Entities.--
``(1) In general.--With respect to any contract that a
State enters into on or after January 1, 2020, with a managed
care entity (as defined in section 1932(a)(1)(B)) pursuant to
section 1903(m), the State shall, as a condition of the
contract, require the managed care entity--
``(A) to operate a qualified drug management
program (as defined in subsection (b)) for at-risk
beneficiaries who are enrolled with such entity and
identified by the managed care entity by means of
application of paragraph (2);
``(B) to submit to the State an annual report on
the matters described in subparagraphs (A) through (E)
of subsection (e)(1); and
``(C) to submit to the State a list (and as
necessary update such list) of individuals enrolled
with such entity under the qualified drug management
program operated by such entity under subparagraph (A)
for purposes of allowing State plans for which medical
assistance is paid on a fee-for-service basis to have
access to such information.
``(2) Application.--For purposes of applying, with respect
to a managed care entity--
``(A) under paragraph (1)(A)--
``(i) the definition of the term `qualified
drug management program' under subsection (b),
other than paragraph (2)(D) of such subsection;
and
``(ii) the provisions of paragraphs (1) and
(2) of subsection (c); and
``(B) under paragraph (1)(B), the report
requirements described in subparagraphs (A) through (E)
of subsection (e)(1);
each reference in such subsection (b) and paragraphs of
subsection (c) to `a State' or `the State' (other than to `a
State plan' or `the State plan') shall be deemed a reference to
the managed care entity, each reference under such subsection,
paragraphs, or subparagraphs to individuals enrolled under the
State plan (or waiver of the State plan) shall be deemed a
reference to individuals enrolled with such entity, and each
reference under such subsection, paragraphs, or subparagraphs
to individuals enrolled under the qualified drug management
program operated by the State shall be deemed a reference to
individuals enrolled under the qualified drug management
program operated by the managed care entity.
``(g) Controlled Substance Defined.--For purposes of this section,
the term `controlled substance' means a drug that is included in
schedule II, III, or IV of section 202(c) of the Controlled Substances
Act, or any combination thereof, as specified by the State.''.
(b) Guidance on At-Risk Population Transitioning Between Medicaid
FFS and Managed Care.--Not later than October 1, 2019, the Secretary of
Health and Human Services shall issue guidance for State Medicaid
programs, with respect to individuals who are enrolled under a State
plan (or waiver of such plan) under title XIX of the Social Security
Act and under a drug management program, for purposes of providing best
practices--
(1) for transitioning, as applicable, such individuals from
fee-for-service Medicaid (and such a program operated by the
State) to receiving medical assistance under such title through
a managed care entity (as defined in section 1932(a)(1)(B) of
the Social Security Act) with a contract that with the State
pursuant to section 1903(m) of such Act (and such a program
operated by such entity); and
(2) for transitioning, as applicable, such individuals from
receiving medical assistance under such title through a managed
care entity (as defined in section 1932(a)(1)(B) of the Social
Security Act) with a contract that with the State pursuant to
section 1903(m) of such Act (and such a program operated by
such entity) to fee-for-service Medicaid (and such a program
operated by the State).
(c) Guidance on At-Risk Population Transitioning to Medicare.--
(1) In general.--Not later than January 1, 2020, the
Secretary of Health and Human Services, after consultation with
the Federal Coordinated Health Care Office established under
section 2602 of the Patient Protection and Affordable Care Act
(42 U.S.C. 1315b), shall issue guidance for State Medicaid
programs, with respect to transitioning individuals, providing
for--
(A) notification to be submitted by the State to
the Centers for Medicare & Medicaid Services and such
individuals of the status of such individuals as
transitioning individuals;
(B) notification to such individuals about
enrollment under a prescription drug plan under part D
of such title or under a MA-PD plan under part C of
such title;
(C) best practices for transitioning such
individuals to such a plan; and
(D) best practices for coordination between the
qualified drug management program (as described in
section 1927A(b) of the Social Security Act, as added
by subsection (a)) carried out by the State and a drug
management program carried out under such a plan
pursuant to section 1860D-4(c)(5) of the Social
Security Act (42 U.S.C. 1395w-10(c)(5)).
(2) Transitioning individuals.--For purposes of paragraph
(1), a transitioning individual is an individual who, with
respect to a month--
(A) is enrolled under the State plan (or waiver of
the State plan) and under the qualified drug management
program (as described in section 1927A(b) of the Social
Security Act, as added by subsection (a)) carried out
by the State; and
(B) is expected to become eligible for the Medicare
program under title XVIII of such Act during the
subsequent 12-month period.
SEC. 105. MEDICAID DRUG REVIEW AND UTILIZATION.
(a) Medicaid Drug Utilization Review.--
(1) State plan requirement.--Section 1902(a) of the Social
Security Act (42 U.S.C. 1396a(a)), as amended by section 101,
is further amended--
(A) in paragraph (83), at the end, by striking
``and'';
(B) in paragraph (84), at the end, by striking the
period and inserting ``; and''; and
(C) by inserting after paragraph (84) the following
new paragraph:
``(85) provide that the State is in compliance with the
drug review and utilization requirements under subsection
(oo)(1).''.
(2) Drug review and utilization requirements.--Section 1902
of the Social Security Act (42 U.S.C. 1396a), as amended by
section 101, is further amended by adding at the end the
following new subsection:
``(oo) Drug Review and Utilization Requirements.--
``(1) In general.--For purposes of subsection (a)(85), the
drug review and utilization requirements under this subsection
are, subject to paragraph (3) and beginning October 1, 2019,
the following:
``(A) Claims review limitations.--
``(i) In general.--The State has in place--
``(I) safety edits (as specified by
the State) for subsequent fills for
opioids and a claims review automated
process (as designed and implemented by
the State) that indicates when an
individual enrolled under the State
plan (or under a waiver of the State
plan) is prescribed a subsequent fill
of opioids in excess of any limitation
that may be identified by the State;
``(II) safety edits (as specified
by the State) on the maximum daily
morphine equivalent that can be
prescribed to an individual enrolled
under the State plan (or under a waiver
of the State plan) for treatment of
chronic pain and a claims review
automated process (as designed and
implemented by the State) that
indicates when an individual enrolled
under the plan (or waiver) is
prescribed the morphine equivalent for
such treatment in excess of any
limitation that may be identified by
the State; and
``(III) a claims review automated
process (as designed and implemented by
the State) that monitors when an
individual enrolled under the State
plan (or under a waiver of the State
plan) is concurrently prescribed
opioids and--
``(aa) benzodiazepines; or
``(bb) antipsychotics.
``(ii) Managed care entities.--The State
requires each managed care entity (as defined
in section 1932(a)(1)(B)) with respect to which
the State has a contract under section 1903(m)
or under section 1905(t)(3) to have in place,
subject to paragraph (3), with respect to
individuals who are eligible for medical
assistance under the State plan (or under a
waiver of the State plan) and who are enrolled
with the entity, the limitations described in
subclauses (I) and (II) of clause (i) and a
claims review automated process described in
subclause (III) of such clause.
``(iii) Rules of construction.--Nothing in
this subparagraph may be construed as
prohibiting a State or managed care entity from
designing and implementing a claims review
automated process under this subparagraph that
provides for prospective or retrospective
reviews of claims. Nothing in this subparagraph
shall be understood as prohibiting the exercise
of clinical judgment from a provider enrolled
as a participating provider in a State plan (or
waiver of the State plan) or contracting with a
managed care entity regarding the best items
and services for an individual enrolled under
such State plan (or waiver).
``(B) Program to monitor antipsychotic medications
by children.--The State has in place a program (as
designed and implemented by the State) to monitor and
manage the appropriate use of antipsychotic medications
by children enrolled under the State plan (or under a
waiver of the State plan) and submits annually to the
Secretary such information as the Secretary may require
on activities carried out under such program for
individuals not more than the age of 18 years generally
and children in foster care specifically.
``(C) Fraud and abuse identification.--The State
has in place a process (as designed and implemented by
the State) that identifies potential fraud or abuse of
controlled substances by individuals enrolled under the
State plan (or under a waiver of the State plan),
health care providers prescribing drugs to individuals
so enrolled, and pharmacies dispensing drugs to
individuals so enrolled.
``(D) Reports.--The State shall include in the
annual report submitted to the Secretary under section
1927(g)(3)(D) information on the limitations,
requirement, program, and processes applied by the
State under subparagraphs (A) through (C) in accordance
with such manner and time as specified by the
Secretary.
``(E) Clarification.--Nothing shall prevent a State
from satisfying the requirement--
``(i) described in subparagraph (A) by
having safety edits or a claims review
automated process described in such
subparagraph that was in place before October
1, 2019;
``(ii) described in subparagraph (B) by
having a program described in such subparagraph
that was in place before such date; or
``(iii) described in subparagraph (C) by
having a process described in such subparagraph
that was in place before such date.
``(2) Annual report by secretary.--For each fiscal year
beginning with fiscal year 2020, the Secretary shall submit to
Congress a report on the most recent information submitted by
States under paragraph (1)(D).
``(3) Exceptions.--
``(A) Certain individuals exempted.--The drug
review and utilization requirements under this
subsection shall not apply with respect to an
individual who--
``(i) is receiving--
``(I) hospice or palliative care;
or
``(II) treatment for cancer;
``(ii) is a resident of a long-term care
facility, of a facility described in section
1905(d), or of another facility for which
frequently abused drugs are dispensed for
residents through a contract with a single
pharmacy; or
``(iii) the State elects to treat as
exempted from such requirements.
``(B) Exception relating to ensuring access.--In
order to ensure reasonable access to health care, the
Secretary shall waive the drug review and utilization
requirements under this subsection, with respect to a
State, in the case of natural disasters and similar
situations, and in the case of the provision of
emergency services (as defined for purposes of section
1860D-4(c)(5)(D)(ii)(II)).''.
(3) Managed care entities.--Section 1932 of the Social
Security Act (42 U.S.C. 1396u-2) is amended by adding at the
end the following new subsection:
``(i) Drug Utilization Review Activities and Requirements.--
Beginning not later than October 1, 2019, each contract under a State
plan with a managed care entity (other than a primary care case
manager) under section 1903(m) shall provide that the entity is in
compliance with the applicable provisions of section 438.3(s)(2) of
title 42 of the Code of Federal Regulations, section 483.3(s)(4)) of
such title, and section 483.3(s)(5) of such title, as such provisions
were in effect on March 31, 2018.''.
(b) Identifying and Addressing Inappropriate Prescribing and
Billing Practices Under Medicaid.--
(1) In general.--Section 1927(g) of the Social Security Act
(42 U.S.C. 1396r-8(g)) is amended--
(A) in paragraph (1)(A)--
(i) by striking ``of section
1903(i)(10)(B)'' and inserting ``of section
1902(a)(54)'';
(ii) by striking ``, by not later than
January 1, 1993,'';
(iii) by inserting after ``gross overuse,''
the following: ``excessive utilization,''; and
(iv) by striking ``or inappropriate or
medically unnecessary care'' and inserting
``inappropriate or medically unnecessary care,
or prescribing or billing practices that
indicate abuse or excessive utilization''; and
(B) in paragraph (2)(B)--
(i) by inserting after ``gross overuse,''
the following: ``excessive utilization,''; and
(ii) by striking ``or inappropriate or
medically unnecessary care'' and inserting
``inappropriate or medically unnecessary care,
or prescribing or billing practices that
indicate abuse or excessive utilization''.
(2) Effective date.--The amendments made by paragraph (1)
shall take effect with respect to retrospective drug use
reviews conducted on or after October 1, 2020.
SEC. 106. GUIDANCE TO IMPROVE CARE FOR INFANTS WITH NEONATAL ABSTINENCE
SYNDROME AND THEIR MOTHERS; GAO STUDY ON GAPS IN MEDICAID
COVERAGE FOR PREGNANT AND POSTPARTUM WOMEN WITH SUBSTANCE
USE DISORDER.
(a) Guidance.--Not later than one year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
issue guidance to improve care for infants with neonatal abstinence
syndrome and their families. Such guidance shall include--
(1) the types of services, including post-discharge
services and parenting supports, for families of babies with
neonatal abstinence syndrome that States may cover under the
Medicaid program under title XIX of the Social Security Act;
(2) best practices from States with respect to innovative
or evidenced-based payment models that focus on prevention,
screening, treatment, plans of safe care, and post-discharge
services for mothers and fathers with substance use disorders
and babies with neonatal abstinence syndrome that improve care
and clinical outcomes;
(3) recommendations for States on available financing
options under the Medicaid program under title XIX of such Act
and under the Children's Health Insurance Program under title
XXI of such Act for Children's Health Insurance Program Health
Services Initiative funds for parents with substance use
disorders, infants with neonatal abstinence syndrome, and home
visiting services; and
(4) guidance and technical assistance to State Medicaid
agencies regarding additional flexibilities and incentives
related to screening, prevention, and post-discharge services,
including parenting supports.
(b) GAO Study.--Not later than one year after the date of the
enactment of this Act, the Comptroller General of the United States
shall conduct a study, and submit to Congress a report, addressing gaps
in coverage for pregnant women with substance use disorder under the
Medicaid program under title XIX of the Social Security Act, and gaps
in coverage for postpartum women with substance use disorder who had
coverage during their pregnancy under the Medicaid program under such
title.
SEC. 107. MEDICAID HEALTH HOMES FOR OPIOID-USE-DISORDER MEDICAID
ENROLLEES.
(a) Extension of Enhanced FMAP for Certain Health Homes for
Individuals With Substance Use Disorders.--Section 1945 of the Social
Security Act (42 U.S.C. 1396w-4) is amended--
(1) in subsection (c)--
(A) in paragraph (1), by inserting ``subject to
paragraph (4),'' after ``except that,''; and
(B) by adding at the end the following new
paragraph:
``(4) Special rule relating to substance use disorder
health homes.--
``(A) In general.--In the case of a State with an
SUD-focused State plan amendment approved by the
Secretary on or after October 1, 2018, the Secretary
may, at the request of the State, extend the
application of the Federal medical assistance
percentage described in paragraph (1) to payments for
the provision of health home services to SUD-eligible
individuals under such State plan amendment, in
addition to the first 8 fiscal year quarters the State
plan amendment is in effect, for the subsequent 2
fiscal year quarters that the State plan amendment is
in effect. Nothing in this section shall be construed
as prohibiting a State with a State plan amendment that
is approved under this section and that is not an SUD-
focused State plan amendment from additionally having
approved on or after such date an SUD-focused State
plan amendment under this section, including for
purposes of application of this paragraph.
``(B) Report requirements.--In the case of a State
with an SUD-focused State plan amendment for which the
application of the Federal medical assistance
percentage has been extended under subparagraph (A),
such State shall, at the end of the period of such
State plan amendment, submit to the Secretary a report
on the following, with respect to SUD-eligible
individuals provided health home services under such
State plan amendment:
``(i) The quality of health care provided
to such individuals, with a focus on outcomes
relevant to the recovery of each such
individual.
``(ii) The access of such individuals to
health care.
``(iii) The total expenditures of such
individuals for health care.
For purposes of this subparagraph, the
Secretary shall specify all applicable measures
for determining quality, access, and
expenditures.
``(C) Best practices.--Not later than October 1,
2020, the Secretary shall make publicly available on
the Internet website of the Centers for Medicare &
Medicaid Services best practices for designing and
implementing an SUD-focused State plan amendment, based
on the experiences of States that have State plan
amendments approved under this section that include
SUD-eligible individuals.
``(D) Definitions.--For purposes of this paragraph:
``(i) SUD-eligible individuals.--The term
`SUD-eligible individual' means, with respect
to a State, an individual who satisfies all of
the following:
``(I) The individual is an eligible
individual with chronic conditions.
``(II) The individual is an
individual with a substance use
disorder.
``(III) The individual has not
previously received health home
services under any other State plan
amendment approved for the State under
this section by the Secretary.
``(ii) SUD-focused state plan amendment.--
The term `SUD-focused State plan amendment'
means a State plan amendment under this section
that is designed to provide health home
services primarily to SUD-eligible
individuals.''.
(b) Requirement for State Medicaid Plans To Provide Coverage for
Medication-Assisted Treatment.--
(1) Requirement for state medicaid plans to provide
coverage for medication-assisted treatment.--Section
1902(a)(10)(A) of the Social Security Act (42 U.S.C.
1396a(a)(10)(A)) is amended, in the matter preceding clause
(i), by striking ``and (28)'' and inserting ``(28), and (29)''.
(2) Inclusion of medication-assisted treatment as medical
assistance.--Section 1905(a) of the Social Security Act (42
U.S.C. 1396d(a)) is amended--
(A) in paragraph (28), by striking ``and'' at the
end;
(B) by redesignating paragraph (29) as paragraph
(30); and
(C) by inserting after paragraph (28) the following
new paragraph:
``(29) subject to paragraph (2) of subsection (ee), for the
period beginning October 1, 2020, and ending September 30,
2025, medication-assisted treatment (as defined in paragraph
(1) of such subsection); and''.
(3) Medication-assisted treatment defined; waivers.--
Section 1905 of the Social Security Act (42 U.S.C. 1396d) is
amended by adding at the end the following new subsection:
``(ee) Medication-Assisted Treatment.--
``(1) Definition.--For purposes of subsection (a)(29), the
term `medication-assisted treatment'--
``(A) means all drugs approved under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), including methadone, and all biological products
licensed under section 351 of the Public Health Service
Act (42 U.S.C. 262) to treat opioid use disorders; and
``(B) includes, with respect to the provision of
such drugs and biological products, counseling services
and behavioral therapy.
``(2) Exception.--The provisions of paragraph (29) of
subsection (a) shall not apply with respect to a State for the
period specified in such paragraph, if before the beginning of
such period the State certifies to the satisfaction of the
Secretary that implementing such provisions statewide for all
individuals eligible to enroll in the State plan (or waiver of
the State plan) would not be feasible by reason of a shortage
of qualified providers of medication-assisted treatment, or
facilities providing such treatment, that will contract with
the State or a managed care entity with which the State has a
contract under section 1903(m) or under section 1905(t)(3).''.
(4) Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall apply with
respect to medical assistance provided on or after
October 1, 2020, and before October 1, 2025.
(B) Exception for state legislation.--In the case
of a State plan under title XIX of the Social Security
Act (42 U.S.C. 1396 et seq.) that the Secretary of
Health and Human Services determines requires State
legislation in order for the respective plan to meet
any requirement imposed by the amendments made by this
subsection, the respective plan shall not be regarded
as failing to comply with the requirements of such
title solely on the basis of its failure to meet such
an additional requirement before the first day of the
first calendar quarter beginning after the close of the
first regular session of the State legislature that
begins after the date of the enactment of this Act. For
purposes of the previous sentence, in the case of a
State that has a 2-year legislative session, each year
of the session shall be considered to be a separate
regular session of the State legislature.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 201. AUTHORITY NOT TO APPLY CERTAIN MEDICARE TELEHEALTH
REQUIREMENTS IN THE CASE OF CERTAIN TREATMENT OF A
SUBSTANCE USE DISORDER OR CO-OCCURRING MENTAL HEALTH
DISORDER.
Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is
amended--
(1) in paragraph (2)(B)(i), by inserting ``and paragraph
(7)(E)'' after ``Subject to clause (ii)''; and
(2) by adding at the end the following new paragraphs:
``(7) Authority not to apply certain requirements in the
case of certain treatment of substance use disorder or co-
occurring mental health disorder.--
``(A) In general.--For purposes of payment under
this subsection, in the case of telehealth services
described in subparagraph (C) furnished on or after
January 1, 2020, to an eligible beneficiary (as defined
in subparagraph (F)) for the treatment of a substance
use disorder or a mental health disorder that is co-
occurring with a substance use disorder, the Secretary
is authorized to, through rulemaking, not apply any of
the requirements described in subparagraph (B).
``(B) Requirements described.--For purposes of this
paragraph, the requirements described in this
subparagraph are any of the following:
``(i) Qualifications for an originating
site under paragraph (4)(C)(ii).
``(ii) Geographic limitations under
paragraph (4)(C)(i).
``(C) Telehealth services described.--For purposes
of this paragraph, the telehealth services described in
this subparagraph are services that are both telehealth
services and identified by the Secretary, through
rulemaking, as services that are the most commonly
furnished (as defined by the Secretary) under this part
to individuals diagnosed with a substance use disorder
or a mental health disorder that is co-occurring with a
substance use disorder.
``(D) Clarification.--Nothing in this paragraph
shall be construed as limiting or otherwise affecting
the authority of the Secretary to limit or eliminate
the non-application pursuant to this paragraph of any
of the requirements under subparagraph (B).
``(E) Treatment of originating site facility fee.--
No facility fee shall be paid under paragraph (2)(B) to
an originating site with respect to a telehealth
service described in subparagraph (B) for which payment
is made under this subsection by reason of the non-
application of a requirement described in subparagraph
(B) pursuant to this paragraph if payment for such
service would not otherwise be permitted under this
subsection if such requirement were applied.
``(F) Eligible beneficiary defined.--For purposes
of this paragraph, the term `eligible beneficiary'
means an individual who--
``(i) is entitled to, or enrolled for,
benefits under part A and enrolled for benefits
under this part;
``(ii) has a diagnosis for a substance use
disorder; and
``(iii) meets such other criteria as the
Secretary determines appropriate.
``(G) Report.--Not later than 5 years after the
date of the enactment of this paragraph, the Secretary
shall submit to Congress a report on the impact of any
non-application under this paragraph of any of the
requirements described in subparagraph (B) on
``(i) the utilization of health care
services related to substance use disorder,
such as behavioral health services and
emergency department visits; and
``(ii) health outcomes related to substance
use disorder, such as substance use overdose
deaths.
``(H) Funding.--For purposes of carrying out this
paragraph, in addition to funds otherwise available,
the Secretary shall provide for the transfer, from the
Federal Supplementary Medical Insurance Trust Fund
under section 1841, of $3,000,000 to the Centers for
Medicare & Medicaid Services Program Management Account
to remain available until expended.
``(8) Rule of construction.--Nothing in this subsection may
be construed as waiving requirements under this title to comply
with applicable State law, including State licensure
requirements.''.
SEC. 202. ENCOURAGING THE USE OF NON-OPIOID ANALGESICS FOR THE
MANAGEMENT OF POST-SURGICAL PAIN.
Section 1833(t)(6) of the Social Security Act (42 U.S.C.
1395l(t)(6)) is amended--
(1) in subparagraph (C)(i), by inserting ``or, in the case
of an eligible non-opioid analgesic (as defined in subparagraph
(J)), during a period of 5 years,'' after ``3 years,''; and
(2) by adding at the end the following new subparagraph:
``(J) Eligible non-opioid analgesic defined.--In
this paragraph, the term `eligible non-opioid
analgesic' means a drug or biological--
``(i) that is an analgesic that is not an
opioid;
``(ii) that demonstrated substantial
clinical improvement; and
``(iii) for which payment--
``(I) as an outpatient hospital
service under this part was not being
made as of the date of the enactment of
this subparagraph; or
``(II) was being made under this
paragraph as of such date.''.
SEC. 203. REQUIRING A REVIEW OF CURRENT OPIOID PRESCRIPTIONS FOR
CHRONIC PAIN AND SCREENING FOR OPIOID USE DISORDER TO BE
INCLUDED IN THE WELCOME TO MEDICARE INITIAL PREVENTIVE
PHYSICAL EXAMINATION.
(a) In General.--Section 1861(ww) of the Social Security Act (42
U.S.C. 1395x(ww)) is amended--
(1) in paragraph (1), by inserting ``and a review of
current opioid prescriptions and screening for opioid use
disorder (as defined in paragraph (4)),'' before ``but does not
include''; and
(2) by adding at the end the following new paragraph:
``(4)(A) For purposes of paragraph (1), the term `a review of
current opioid prescriptions and screening for opioid use disorder'
means, with respect to an individual--
``(i) a review by a physician or qualified non-physician
practitioner of all current prescriptions of the individual;
and
``(ii) in the case of an individual determined by the
review of a physician or qualified non-physician practitioner
under subparagraph (A) to have a current prescription for
opioids for chronic pain that has been prescribed for a minimum
period of time (as specified by the Secretary)--
``(I) a review by the physician or practitioner of
the potential risk factors to the individual for opioid
use disorder;
``(II) an evaluation by the physician or
practitioner of pain of the individual;
``(III) the provision of information regarding non-
opioid treatment options for the treatment and
management of any chronic pain of the individual; and
``(IV) if determined necessary by the physician or
practitioner based on the results of the review and
evaluation conducted as described in this paragraph, an
appropriate referral by the physician or practitioner
for additional treatment.
``(B) For purposes of this paragraph, the term `qualified non-
physician practitioner' means a physician assistant, nurse
practitioner, or certified clinical nurse specialist.''.
(b) Effective Date.--The amendments made by subsection (a) shall
apply with respect to initial preventive physical examinations
furnished on or after January 1, 2020.
SEC. 204. MODIFICATION OF PAYMENT FOR CERTAIN OUTPATIENT SURGICAL
SERVICES.
(a) Freeze of Payment for Certain Services Furnished in Ambulatory
Surgical Centers.--Section 1833(i)(2) of the Social Security Act (42
U.S.C. 1395l(i)(2)) is amended by adding at the end the following new
subparagraph:
``(F)(i) With respect to a targeted procedure (as defined
in clause (ii)) furnished during 2020 or a subsequent year
(before 2024) to an individual in an ambulatory surgical
center, the payment amount for such procedure that would
otherwise be determined under the revised payment system under
subparagraph (D), without application of this subparagraph,
shall be equal to the payment amount for such procedure
furnished in 2016.
``(ii) For purposes of clause (i), the term `targeted
procedure' means a procedure to which Healthcare Common
Procedure Coding System 62310 (or, for years beginning after
2016, 62321), 62311 (or, for years beginning after 2016,
62323), 62264, 64490, 64493, or G0260 (or any successor code)
applies.
``(iii) This subparagraph shall not be applied in a budget-
neutral manner.''.
(b) Data Collection.--
(1) In general.--The Comptroller General shall collect data
relating to the cost differential between targeted procedures
(as defined in section 1833(i)(2)(F)(ii) of the Social Security
Act, as added by subsection (a)) that are performed in a
hospital operating room and such procedures that are performed
in an office setting within a hospital in order to determine
whether such procedures are being properly coded for claims,
based on setting, for payment under section 1833(i)(2)(D) of
the Social Security Act (42 U.S.C. 1395l(i)(2)(D)) and to
determine if further changes are needed in the classification
system for covered outpatient department services (as described
in section 1833(t)(2)(A) of the Social Security Act (42 U.S.C.
1395l(t)(2)(A)).
(2) Report.--Not later than 4 years after the date of the
enactment of this Act, the Comptroller General shall submit a
report to the Committee on Energy and Commerce and the
Committee on Ways and Means of the House of Representatives and
the Committee on Finance of the Senate containing--
(A) a determination of whether procedures described
in paragraph (1) are being properly coded for claims,
based on setting, for payment under section
1833(i)(2)(D) of the Social Security Act (42 U.S.C.
1395l(i)(2)(D)); and
(B) recommendations on any changes the Comptroller
General determines are needed in the classification
system for covered outpatient department services (as
described in section 1833(t)(2)(A) of the Social
Security Act (42 U.S.C. 1395l(t)(2)(A)).
(c) Study.--Not later than 3 years after the date of the enactment
of this Act, the Secretary of Health and Human Services shall conduct a
study and submit to Congress a report on the extent to which procedures
described in section 1833(i)(2)(F)(ii) of the Social Security Act, as
added by subsection (a), are effective at preventing the need for
opioids for individuals furnished such procedures.
SEC. 205. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED PART D
CONTROLLED SUBSTANCES.
(a) In General.--Section 1860D-4(e) of the Social Security Act (42
U.S.C. 1395w-104(e)) is amended by adding at the end the following:
``(7) Requirement of e-prescribing for controlled
substances.--
``(A) In general.--Subject to subparagraph (B), a
prescription for a covered part D drug under a
prescription drug plan (or under an MA-PD plan) for a
schedule II, III, IV, or V controlled substance shall
be transmitted by a health care practitioner
electronically in accordance with an electronic
prescription drug program that meets the requirements
of paragraph (2).
``(B) Exception for certain circumstances.--The
Secretary shall, pursuant to rulemaking, specify
circumstances with respect to which the Secretary may
waive the requirement under subparagraph (A), with
respect to a covered part D drug, including in the case
of--
``(i) a prescription issued when the
practitioner and dispenser are the same entity;
``(ii) a prescription issued that cannot be
transmitted electronically under the most
recently implemented version of the National
Council for Prescription Drug Programs SCRIPT
Standard;
``(iii) a prescription issued by a
practitioner who has received a waiver or a
renewal thereof for a specified period
determined by the Secretary, not to exceed one
year, from the requirement to use electronic
prescribing, pursuant to a process established
by regulation by the Secretary, due to
demonstrated economic hardship, technological
limitations that are not reasonably within the
control of the practitioner, or other
exceptional circumstance demonstrated by the
practitioner;
``(iv) a prescription issued by a
practitioner under circumstances in which,
notwithstanding the practitioner's ability to
submit a prescription electronically as
required by this subsection, such practitioner
reasonably determines that it would be
impractical for the individual involved to
obtain substances prescribed by electronic
prescription in a timely manner, and such delay
would adversely impact the individual's medical
condition involved;
``(v) a prescription issued by a
practitioner allowing for the dispensing of a
non-patient specific prescription pursuant to a
standing order, approved protocol for drug
therapy, collaborative drug management, or
comprehensive medication management, in
response to a public health emergency, or other
circumstances where the practitioner may issue
a non-patient specific prescription;
``(vi) a prescription issued by a
practitioner prescribing a drug under a
research protocol;
``(vii) a prescription issued by a
practitioner for a drug for which the Food and
Drug Administration requires a prescription to
contain elements that are not able to be
included in electronic prescribing, such as a
drug with risk evaluation and mitigation
strategies that include elements to assure safe
use; and
``(viii) a prescription issued by a
practitioner for an individual who--
``(I) receives hospice care under
this title; or
``(II) is a resident of a skilled
nursing facility (as defined in section
1819(a)), or a medical institution or
nursing facility for which payment is
made for an institutionalized
individual under section 1902(q)(1)(B),
for which frequently abused drugs are
dispensed for residents through a
contract with a single pharmacy, as
determined by the Secretary in
accordance with this paragraph.
``(C) Dispensing.--Nothing in this paragraph shall
be construed as requiring a sponsor of a prescription
drug plan under this part, MA organization offering an
MA-PD plan under part C, or a pharmacist to verify that
a practitioner, with respect to a prescription for a
covered part D drug, has a waiver (or is otherwise
exempt) under subparagraph (B) from the requirement
under subparagraph (A). Nothing in this paragraph shall
be construed as affecting the ability of the plan to
cover or the pharmacists' ability to continue to
dispense covered part D drugs from otherwise valid
written, oral or fax prescriptions that are consistent
with laws and regulations. Nothing in this paragraph
shall be construed as affecting the ability of the
beneficiary involved to designate a particular pharmacy
to dispense a prescribed drug to the extent consistent
with the requirements under subsection (b)(1) and under
this paragraph.
``(D) Enforcement.--The Secretary shall, pursuant
to rulemaking, have authority to enforce and specify
appropriate penalties for non-compliance with the
requirement under subparagraph (A).''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to coverage of drugs prescribed on or after January 1, 2021.
SEC. 206. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS UNDER MEDICARE TO
ESTABLISH DRUG MANAGEMENT PROGRAMS FOR AT-RISK
BENEFICIARIES.
Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-
104(c)) is amended--
(1) in paragraph (1), by inserting after subparagraph (E)
the following new subparagraph:
``(F) With respect to plan years beginning on or
after January 1, 2021, a drug management program for
at-risk beneficiaries described in paragraph (5).'';
and
(2) in paragraph (5)(A), by inserting ``(and for plan years
beginning on or after January 1, 2021, a PDP sponsor shall)''
after ``A PDP sponsor may''.
SEC. 207. MEDICARE COVERAGE OF CERTAIN SERVICES FURNISHED BY OPIOID
TREATMENT PROGRAMS.
(a) Coverage.--Section 1861(s)(2) of the Social Security Act (42
U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (FF), by striking at the end ``and'';
(2) in subparagraph (GG), by inserting at the end ``;
and''; and
(3) by adding at the end the following new subparagraph:
``(HH) opioid use disorder treatment services (as
defined in subsection (jjj)).''.
(b) Opioid Use Disorder Treatment Services and Opioid Treatment
Program Defined.--Section 1861 of the Social Security Act is amended by
adding at the end the following new subsection:
``(jjj) Opioid Use Disorder Treatment Services; Opioid Treatment
Program.--
``(1) Opioid use disorder treatment services.--The term
`opioid use disorder treatment services' means items and
services that are furnished by an opioid treatment program for
the treatment of opioid use disorder, including--
``(A) opioid agonist and antagonist treatment
medications (including oral, injected, or implanted
versions) that are approved by the Food and Drug
Administration under section 505 of the Federal Food,
Drug and Cosmetic Act for use in the treatment of
opioid use disorder;
``(B) dispensing and administration of such
medications, if applicable;
``(C) substance use counseling by a professional to
the extent authorized under State law to furnish such
services;
``(D) individual and group therapy with a physician
or psychologist (or other mental health professional to
the extent authorized under State law);
``(E) toxicology testing, and
``(F) other items and services that the Secretary
determines are appropriate (but in no event to include
meals or transportation).
``(2) Opioid treatment program.--The term `opioid treatment
program' means an entity that is opioid treatment program (as
defined in section 8.2 of title 42 of the Code of Federal
Regulations, or any successor regulation) that--
``(A) is enrolled under section 1866(j);
``(B) has in effect a certification by the
Substance Abuse and Mental Health Services
Administration for such a program;
``(C) is accredited by an accrediting body approved
by the Substance Abuse and Mental Health Services
Administration; and
``(D) meets such additional conditions as the
Secretary may find necessary to ensure--
``(i) the health and safety of individuals
being furnished services under such program;
and
``(ii) the effective and efficient
furnishing of such services.''.
(c) Payment.--
(1) In general.--Section 1833(a)(1) of the Social Security
Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and (BB)'' and inserting
``(BB)''; and
(B) by inserting before the semicolon at the end
the following ``, and (CC) with respect to opioid use
disorder treatment services furnished during an episode
of care, the amount paid shall be equal to the amount
payable under section 1834(w) less any copayment
required as specified by the Secretary''.
(2) Payment determination.--Section 1834 of the Social
Security Act (42 U.S.C. 1395m) is amended by adding at the end
the following new subsection:
``(w) Opioid Use Disorder Treatment Services.--
``(1) In general.--The Secretary shall pay to an opioid
treatment program (as defined in paragraph (2) of section
1861(jjj)) an amount that is equal to 100 percent of a bundled
payment under this part for opioid use disorder treatment
services (as defined in paragraph (1) of such section) that are
furnished by such program to an individual during an episode of
care (as defined by the Secretary) beginning on or after
January 1, 2020. The Secretary shall ensure, as determined
appropriate by the Secretary, that no duplicative payments are
made under this part or part D for items and services furnished
by an opioid treatment program.
``(2) Considerations.--The Secretary may implement this
subsection through one or more bundles based on the type of
medication provided (such as buprenorphine, methadone,
naltrexone, or a new innovative drug), the frequency of
services, the scope of services furnished, characteristics of
the individuals furnished such services, or other factors as
the Secretary determine appropriate. In developing such
bundles, the Secretary may consider payment rates paid to
opioid treatment programs for comparable services under State
plans under title XIX or under the TRICARE program under
chapter 55 of title 10 of the United States Code.
``(3) Annual updates.--The Secretary shall provide an
update each year to the bundled payment amounts under this
subsection.''.
(d) Including Opioid Treatment Programs as Medicare Providers.--
Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is
amended--
(1) in paragraph (1), by striking at the end ``and'';
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following new paragraph:
``(3) opioid treatment programs (as defined in paragraph
(2) of section 1861(jjj)), but only with respect to the
furnishing of opioid use disorder treatment services (as
defined in paragraph (1) of such section).''.
TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 301. CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN AND ADDICTION
THERAPIES.
(a) Public Meetings.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall hold not less
than one public meeting to address the challenges and barriers of
developing non-addictive medical products intended to treat pain or
addiction, which may include--
(1) the application of novel clinical trial designs
(consistent with section 3021 of the 21st Century Cures Act
(Public Law 114-255)), use of real world evidence (consistent
with section 505F of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355g)), and use of patient experience data
(consistent with section 569C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-8c)) for the development of non-
addictive medical products intended to treat pain or addiction;
and
(2) the application of eligibility criteria under sections
506 and 515B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e-3) for non-addictive medical products intended
to treat pain or addiction.
(b) Guidance.--Not later than one year after the public meetings
are conducted under subsection (a) the Secretary shall issue one or
more final guidance documents, or update existing guidance documents,
to help address challenges to developing non-addictive medical products
to treat pain or addiction. Such guidance documents shall include
information regarding--
(1) how the Food and Drug Administration may apply sections
506 and 515B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e-3) to non-addictive medical products intended
to treat pain or addiction, including the circumstances under
which the Secretary--
(A) may apply the eligibility criteria under such
sections 506 and 515B to non-opioid or non-addictive
medical products intended to treat pain or addiction;
(B) considers the risk of addiction of controlled
substances approved to treat pain when establishing
unmet medical need; and
(C) considers pain, pain control, or pain
management in assessing whether a disease or condition
is a serious or life-threatening disease or condition;
and
(2) the methods by which sponsors may evaluate acute and
chronic pain, endpoints for non-addictive medical products
intended to treat pain, the manner in which endpoints and
evaluations of efficacy will be applied across and within
review divisions, taking into consideration the etiology of the
underlying disease, and the manner in which sponsors may use
surrogate endpoints, intermediate endpoints, and real world
evidence.
(c) Medical Product Defined.--In this section, the term ``medical
product'' means a drug (as defined in section 201(g)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product
(as defined in section 351(i) of the Public Health Service Act (42
U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))).
SEC. 302. SURVEILLANCE AND TESTING OF OPIOIDS TO PREVENT FENTANYL
DEATHS.
(a) Public Health Laboratories To Detect Fentanyl.--Part F of title
III of the Public Health Service Act (42 U.S.C. 262 et seq.) is
amended--
(1) in the heading of part F, by striking ``and Clinical
Laboratories'' and inserting ``, Clinical Laboratories, and
Public Health Laboratories''; and
(2) by adding at the end the following new subpart:
``Subpart 4--Public Health Laboratories
``SEC. 355. PUBLIC HEALTH LABORATORIES TO DETECT FENTANYL.
``(a) In General.--The Secretary shall establish a program to award
grants to Federal, State, and local agencies to support the
establishment or operation of public health laboratories to detect
fentanyl, its analogues, and other synthetic opioids, as described in
subsection (b).
``(b) Standards.--The Secretary, in consultation with the Director
of the National Institute of Standards and Technology, shall--
``(1) develop standards for safely and effectively handling
and testing fentanyl, its analogues, and other synthetic
opioids;
``(2) develop fentanyl and fentanyl analog reference
materials and quality control standards and protocols to
calibrate instrumentation for clinical diagnostics and
postmortem surveillance; and
``(3) include in the standards developed pursuant to
paragraph (1) procedures for encountering new and emerging
synthetic opioid formulations and reporting those findings to
other Federal, State, and local public health laboratories.
``(c) Laboratories.--The Secretary shall require grantees under
subsection (a) to--
``(1) follow the standards established under subsection (b)
and be capable of providing systematic and routine laboratory
testing of drugs for the purposes of obtaining and
disseminating public health information to Federal, State, and
local public health officials, laboratories, and other entities
the Secretary deems appropriate;
``(2) work with law enforcement agencies and public health
authorities, as feasible, to develop real-time information on
the purity and movement of fentanyl, its analogues, and other
synthetic opioids;
``(3) assist State and local law enforcement agencies in
testing seized drugs when State and local forensic laboratories
request additional assistance;
``(4) provide early warning information and advice to
Federal, State, and local law enforcement agencies and public
health authorities regarding potential significant changes in
the supply of fentanyl, its analogues, and other synthetic
opioids;
``(5) provide biosurveillance for non-fatal exposures; and
``(6) provide diagnostic testing for non-fatal exposures of
emergency personnel.
``(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $15,000,000 for each of fiscal
years 2019 through 2023.''.
(b) Enhanced Fentanyl Surveillance.--Title III of the Public Health
Service Act is amended by inserting after section 317T of such Act (42
U.S.C. 247b-22) the following new section:
``SEC. 317U. ENHANCED FENTANYL SURVEILLANCE.
``(a) In General.--The Director of the Centers for Disease Control
and Prevention shall enhance its drug surveillance program by--
``(1) expanding its surveillance program to include all 50
States and the territories of the United States;
``(2) increasing and accelerating the collection of data on
fentanyl, its analogues, and other synthetic opioids and new
emerging drugs of abuse, including related overdose data from
medical examiners and drug treatment admissions; and
``(3) utilizing available and emerging information on
fentanyl, its analogues, and other synthetic opioids and new
emerging drugs of abuse, including information from--
``(A) the National Drug Early Warning System;
``(B) State and local public health authorities;
and
``(C) Federal, State, and local public health
laboratories.
``(b) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $10,000,000 for each of fiscal
years 2019 through 2023.''.
(c) Pilot Program for Point-of-Use Testing of Illicit Drugs for
Dangerous Contaminants.--Part P of title III of the Public Health
Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end
the following new section:
``SEC. 399V-7. PILOT PROGRAM FOR POINT-OF-USE TESTING OF ILLICIT DRUGS
FOR DANGEROUS CONTAMINANTS.
``(a) In General.--The Secretary shall--
``(1) establish a pilot program through which 5 State or
local agencies conduct, in 5 States, point-of-use testing of
illicit drugs for dangerous contaminants;
``(2) establish metrics to evaluate the success of the
pilot program in reducing drug overdose rates; and
``(3) based on such metrics, conduct an annual evaluation
of the pilot program and submit an annual report to the
Congress containing the results of such evaluation.
``(b) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $5,000,000 for each of fiscal
years 2019 through 2023.''.
SEC. 303. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT TO MEDICATION-
ASSISTED TREATMENT FOR OPIOID USE DISORDERS.
(a) Conforming Applicable Number.--Subclause (II) of section
303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(B)(iii)) is amended to read as follows:
``(II) The applicable number is--
``(aa) 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;
``(bb) 100 if the practitioner holds additional
credentialing, as defined in section 8.2 of title 42,
Code of Federal Regulations (or successor regulations);
or
``(cc) 100 if the practitioner provides medication-
assisted treatment (MAT) using covered medications (as
such terms are defined in section 8.2 of title 42, Code
of Federal Regulations (or successor regulations)) in a
qualified practice setting (as described in section
8.615 of title 42, Code of Federal Regulations (or
successor regulations)).''.
(b) Eliminating Any Time Limitation for Nurse Practitioners and
Physician Assistants To Become Qualifying Practitioners.--Clause (iii)
of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)) is amended--
(1) in subclause (I), by striking ``or'' at the end; and
(2) by amending subclause (II) to read as follows:
``(II) a qualifying other practitioner, as defined
in clause (iv), who is a nurse practitioner or
physician assistant; or''.
(c) Imposing a Time Limitation for Clinical Nurse Specialists,
Certified Registered Nurse Anesthetists, and Certified Nurse Midwifes
To Become Qualifying Practitioners.--Clause (iii) of section
303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)),
as amended by subsection (b), is further amended by adding at the end
the following:
``(III) for the period beginning on October 1,
2018, and ending on October 1, 2023, a qualifying other
practitioner, as defined in clause (iv), who is a
clinical nurse specialist, certified registered nurse
anesthetist, or certified nurse midwife.''.
(d) Definition of Qualifying Other Practitioner.--Section
303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)(iv)) is amended by striking ``nurse practitioner or
physician assistant'' each place it appears and inserting ``nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, certified nurse midwife, or physician assistant''.
(e) Report by Secretary.--Not later than two years after the date
of the enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Drug Enforcement Administration,
shall submit to Congress a report that assesses the care provided by
qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of
the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are
treating, in the case of physicians, 100 or more patients, and in the
case of qualifying practitioners who are not physicians, 30 or more
patients. Such report shall include recommendations on future
applicable patient number levels and limits. In preparing such report,
the Secretary shall study, with respect to opioid use disorder
treatment--
(1) the average frequency with which qualifying
practitioners see their patients;
(2) the average frequency with which patients receive
counseling, including the rates by which such counseling is
provided by such a qualifying practitioner directly, or by
referral;
(3) the average frequency with which random toxicology
testing is administered;
(4) the average monthly patient caseload for each type of
qualifying practitioner;
(5) the treatment retention rates for patients;
(6) overdose and mortality rates; and
(7) any available information regarding the diversion of
drugs by patients receiving such treatment from such a
qualifying practitioner.
TITLE IV--OFFSETS
SEC. 401. PROMOTING VALUE IN MEDICAID MANAGED CARE.
Section 1903(m) of the Social Security Act (42 U.S.C. 1396b(m)) is
amended by adding at the end the following new paragraph:
``(7)(A) With respect to expenditures described in subparagraph (B)
that are incurred by a State for any fiscal year after fiscal year 2020
(and before fiscal year 2025), in determining the pro rata share to
which the United States is equitably entitled under subsection (d)(3),
the Secretary shall substitute the Federal medical assistance
percentage that applies for such fiscal year to the State under section
1905(b) (without regard to any adjustments to such percentage
applicable under such section or any other provision of law) for the
percentage that applies to such expenditures under section 1905(y).
``(B) Expenditures described in this subparagraph, with respect to
a fiscal year to which subparagraph (A) applies, are expenditures
incurred by a State for payment for medical assistance provided to
individuals described in subclause (VIII) of section 1902(a)(10)(A)(i)
by a managed care entity, or other specified entity (as defined in
subparagraph (D)(iii)), that are treated as remittances because the
State--
``(i) has satisfied the requirement of section 438.8 of
title 42, Code of Federal Regulations (or any successor
regulation), by electing--
``(I) in the case of a State described in
subparagraph (C), to apply a minimum medical loss ratio
(as defined in subparagraph (D)(ii)) that is equal to
or greater than 85 percent; or
``(II) in the case of a State not described in
subparagraph (C), to apply a minimum medical loss ratio
that is equal to 85 percent; and
``(ii) recovered all or a portion of the expenditures as a
result of the entity's failure to meet such ratio.
``(C) For purposes of subparagraph (B), a State described in this
subparagraph is a State that as of May 31, 2018, applied a minimum
medical loss ratio (as calculated under subsection (d) of section 438.8
of title 42, Code of Federal Regulations (as in effect on June 1,
2018)) for payment for services provided by entities described in such
subparagraph under the State plan under this title (or a waiver of the
plan) that is equal to or greater than 85 percent.
``(D) For purposes of this paragraph:
``(i) The term `managed care entity' means a medicaid
managed care organization described in section
1932(a)(1)(B)(i).
``(ii) The term `minimum medical loss ratio' means, with
respect to a State, a minimum medical loss ratio (as calculated
under subsection (d) of section 438.8 of title 42, Code of
Federal Regulations (as in effect on June 1, 2018)) for payment
for services provided by entities described in subparagraph (B)
under the State plan under this title (or a waiver of the
plan).
``(iii) The term `other specified entity' means--
``(I) a prepaid inpatient health plan, as defined
in section 438.2 of title 42, Code of Federal
Regulations (or any successor regulation); and
``(II) a prepaid ambulatory health plan, as defined
in such section (or any successor regulation).''.
SEC. 402. EXTENDING PERIOD OF APPLICATION OF MEDICARE SECONDARY PAYER
RULES FOR INDIVIDUALS WITH END STAGE RENAL DISEASE.
Section 1862(b)(1)(C) of the Social Security Act (42 U.S.C.
1395y(b)(1)(C)) is amended--
(1) in the last sentence, by inserting ``and before January
1, 2020'' after ``date of enactment of the Balanced Budget Act
of 1997''; and
(2) by adding at the end the following new sentence:
``Effective for items and services furnished on or after
January 1, 2020 (with respect to periods beginning on or after
July 1, 2018), clauses (i) and (ii) shall be applied by
substituting `33-month' for `12-month' each place it
appears.''.
SEC. 403. REQUIRING REPORTING BY GROUP HEALTH PLANS OF PRESCRIPTION
DRUG COVERAGE INFORMATION FOR PURPOSES OF IDENTIFYING
PRIMARY PAYER SITUATIONS UNDER THE MEDICARE PROGRAM.
Clause (i) of section 1862(b)(7)(A) of the Social Security Act (42
U.S.C. 1395y(b)(7)(A)) is amended to read as follows:
``(i) secure from the plan sponsor and plan
participants such information as the Secretary
shall specify for the purpose of identifying
situations where the group health plan is or
has been--
``(I) a primary plan to the program
under this title; or
``(II) for calendar quarters
beginning on or after January 1, 2020,
a primary payer with respect to
benefits relating to prescription drug
coverage under part D; and''.
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