[116th Congress Public Law 16]
[From the U.S. Government Publishing Office]
[[Page 851]]
MEDICAID SERVICES INVESTMENT AND ACCOUNTABILITY ACT OF 2019
[[Page 133 STAT. 852]]
Public Law 116-16
116th Congress
An Act
To amend title XIX to extend protection for Medicaid recipients of home
and community-based services against spousal impoverishment, establish a
State Medicaid option to provide coordinated care to children with
complex medical conditions through health homes, prevent the
misclassification of drugs for purposes of the Medicaid drug rebate
program, and for other purposes. <<NOTE: Apr. 18, 2019 - [H.R. 1839]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Medicaid
Services Investment and Accountability Act of 2019. 42 USC 1305 note.>>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medicaid Services Investment and
Accountability Act of 2019''.
SEC. 2. EXTENSION OF PROTECTION FOR MEDICAID RECIPIENTS OF HOME
AND COMMUNITY-BASED SERVICES AGAINST SPOUSAL
IMPOVERISHMENT.
(a) In General.--Section 2404 of Public Law 111-148 (42 U.S.C.
1396r-5 note), as amended by section 3(a) of the Medicaid Extenders Act
of 2019 (Public Law 116-3), is amended by striking ``March 31, 2019''
and inserting ``September 30, 2019''.
(b) <<NOTE: 42 USC 1396r-5 note.>> Rule of Construction.--
(1) Protecting state spousal income and asset disregard
flexibility under waivers and plan amendments.--Nothing in
section 2404 of Public Law 111-148 (42 U.S.C. 1396r-5 note) or
section 1924 of the Social Security Act (42 U.S.C. 1396r-5)
shall be construed as prohibiting a State from disregarding an
individual's spousal income and assets under a State waiver or
plan amendment described in paragraph (2) for purposes of making
determinations of eligibility for home and community-based
services or home and community-based attendant services and
supports under such waiver or plan amendment.
(2) State waiver or plan amendment described.--A State
waiver or plan amendment described in this paragraph is any of
the following:
(A) A waiver or plan amendment to provide medical
assistance for home and community-based services under a
waiver or plan amendment under subsection (c), (d), or
(i) of section 1915 of the Social Security Act (42
U.S.C. 1396n) or under section 1115 of such Act (42
U.S.C. 1315).
(B) A plan amendment to provide medical assistance
for home and community-based services for individuals by
reason of being determined eligible under section
1902(a)(10)(C) of such Act (42 U.S.C. 1396a(a)(10)(C))
or by reason of section 1902(f) of such Act (42 U.S.C.
1396a(f))
[[Page 133 STAT. 853]]
or otherwise on the basis of a reduction of income based
on costs incurred for medical or other remedial care
under which the State disregarded the income and assets
of the individual's spouse in determining the initial
and ongoing financial eligibility of an individual for
such services in place of the spousal impoverishment
provisions applied under section 1924 of such Act (42
U.S.C. 1396r-5).
(C) A plan amendment to provide medical assistance
for home and community-based attendant services and
supports under section 1915(k) of such Act (42 U.S.C.
1396n(k)).
SEC. 3. STATE OPTION TO PROVIDE COORDINATED CARE THROUGH A HEALTH
HOME FOR CHILDREN WITH MEDICALLY COMPLEX
CONDITIONS.
Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is
amended by inserting after section 1945 the following new section:
``SEC. 1945A. <<NOTE: 42 USC 1396w-4a.>> STATE OPTION TO PROVIDE
COORDINATED CARE THROUGH A HEALTH HOME
FOR CHILDREN WITH MEDICALLY COMPLEX
CONDITIONS.
``(a) <<NOTE: Effective date.>> In General.--Notwithstanding
section 1902(a)(1) (relating to statewideness) and section
1902(a)(10)(B) (relating to comparability), beginning October 1, 2022, a
State, at its option as a State plan amendment, may provide for medical
assistance under this title to children with medically complex
conditions who choose to enroll in a health home under this section by
selecting a designated provider, a team of health care professionals
operating with such a provider, or a health team as the child's health
home for purposes of providing the child with health home services.
``(b) <<NOTE: Coordination.>> Health Home Qualification
Standards.--The Secretary shall establish standards for qualification as
a health home for purposes of this section. Such standards shall include
requiring designated providers, teams of health care professionals
operating with such providers, and health teams to demonstrate to the
State the ability to do the following:
``(1) Coordinate prompt care for children with medically
complex conditions, including access to pediatric emergency
services at all times.
``(2) Develop an individualized comprehensive pediatric
family-centered care plan for children with medically complex
conditions that accommodates patient preferences.
``(3) Work in a culturally and linguistically appropriate
manner with the family of a child with medically complex
conditions to develop and incorporate into such child's care
plan, in a manner consistent with the needs of the child and the
choices of the child's family, ongoing home care, community-
based pediatric primary care, pediatric inpatient care, social
support services, and local hospital pediatric emergency care.
``(4) Coordinate access to--
``(A) subspecialized pediatric services and programs
for children with medically complex conditions,
including the most intensive diagnostic, treatment, and
critical care levels as medically necessary; and
``(B) palliative services if the State provides such
services under the State plan (or a waiver of such
plan).
``(5) Coordinate care for children with medically complex
conditions with out-of-State providers furnishing care to such
[[Page 133 STAT. 854]]
children to the maximum extent practicable for the families of
such children and where medically necessary, in accordance with
guidance issued under subsection (e)(1) and section 431.52 of
title 42, Code of Federal Regulations.
``(6) Collect and report information under subsection
(g)(1).
``(c) Payments.--
``(1) In general.--A State shall provide a designated
provider, a team of health care professionals operating with
such a provider, or a health team with payments for the
provision of health home services to each child with medically
complex conditions that selects such provider, team of health
care professionals, or health team as the child's health home.
Payments made to a designated provider, a team of health care
professionals operating with such a provider, or a health team
for such services shall be treated as medical assistance for
purposes of section 1903(a), except that, during the first 2
fiscal year quarters that the State plan amendment is in effect,
the Federal medical assistance percentage applicable to such
payments shall be increased by 15 percentage points, but in no
case may exceed 90 percent.
``(2) Methodology.--
``(A) In general.--The State shall specify in the
State plan amendment the methodology the State will use
for determining payment for the provision of health home
services. Such methodology for determining payment--
``(i) may be tiered to reflect, with respect
to each child with medically complex conditions
provided such services by a designated provider, a
team of health care professionals operating with
such a provider, or a health team, the severity or
number of each such child's chronic conditions,
life-threatening illnesses, disabilities, or rare
diseases, or the specific capabilities of the
provider, team of health care professionals, or
health team; and
``(ii) shall be established consistent with
section 1902(a)(30)(A).
``(B) Alternate models of payment.--The methodology
for determining payment for provision of health home
services under this section shall not be limited to a
per-member per-month basis and may provide (as proposed
by the State and subject to approval by the Secretary)
for alternate models of payment.
``(3) Planning grants.--
``(A) <<NOTE: Effective date.>> In general.--
Beginning October 1, 2022, the Secretary may award
planning grants to States for purposes of developing a
State plan amendment under this section. A planning
grant awarded to a State under this paragraph shall
remain available until expended.
``(B) State contribution.--A State awarded a
planning grant shall contribute an amount equal to the
State percentage determined under section 1905(b)
(without regard to section 5001 of Public Law 111-5) for
each fiscal year for which the grant is awarded.
``(C) Limitation.--The total amount of payments made
to States under this paragraph shall not exceed
$5,000,000.
``(d) Coordinating Care.--
[[Page 133 STAT. 855]]
``(1) <<NOTE: Procedures.>> Hospital notification.--A State
with a State plan amendment approved under this section shall
require each hospital that is a participating provider under the
State plan (or a waiver of such plan) to establish procedures
for, in the case of a child with medically complex conditions
who is enrolled in a health home pursuant to this section and
seeks treatment in the emergency department of such hospital,
notifying the health home of such child of such treatment.
``(2) Education with respect to availability of health home
services.--In order for a State plan amendment to be approved
under this section, a State shall include in the State plan
amendment a description of the State's process for educating
providers participating in the State plan (or a waiver of such
plan) on the availability of health home services for children
with medically complex conditions, including the process by
which such providers can refer such children to a designated
provider, team of health care professionals operating such a
provider, or health team for the purpose of establishing a
health home through which such children may receive such
services.
``(3) Family education.--In order for a State plan amendment
to be approved under this section, a State shall include in the
State plan amendment a description of the State's process for
educating families with children eligible to receive health home
services pursuant to this section of the availability of such
services. Such process shall include the participation of
family-to-family entities or other public or private
organizations or entities who provide outreach and information
on the availability of health care items and services to
families of individuals eligible to receive medical assistance
under the State plan (or a waiver of such plan).
``(4) <<NOTE: Consultation.>> Mental health coordination.--
A State with a State plan amendment approved under this section
shall consult and coordinate, as appropriate, with the Secretary
in addressing issues regarding the prevention and treatment of
mental illness and substance use among children with medically
complex conditions receiving health home services under this
section.
``(e) Guidance on Coordinating Care From Out-of-State Providers.--
``(1) <<NOTE: Deadline.>> In general.--Not later than
October 1, 2020, the Secretary shall issue (and update as the
Secretary determines necessary) guidance to State Medicaid
directors on--
``(A) best practices for using out-of-State
providers to provide care to children with medically
complex conditions;
``(B) coordinating care for such children provided
by such out-of-State providers (including when provided
in emergency and non-emergency situations);
``(C) reducing barriers for such children receiving
care from such providers in a timely fashion; and
``(D) processes for screening and enrolling such
providers in the respective State plan (or a waiver of
such plan), including efforts to streamline such
processes or reduce the burden of such processes on such
providers.
``(2) Stakeholder input.--In carrying out paragraph (1), the
Secretary shall issue a request for information to seek input
from children with medically complex conditions and their
families, States, providers (including children's hospitals,
[[Page 133 STAT. 856]]
hospitals, pediatricians, and other providers), managed care
plans, children's health groups, family and beneficiary
advocates, and other stakeholders with respect to coordinating
the care for such children provided by out-of-State providers.
``(f) <<NOTE: Methodologies.>> Monitoring.--A State shall include
in the State plan amendment--
``(1) a methodology for tracking reductions in inpatient
days and reductions in the total cost of care resulting from
improved care coordination and management under this section;
``(2) <<NOTE: Proposal.>> a proposal for use of health
information technology in providing health home services under
this section and improving service delivery and coordination
across the care continuum (including the use of wireless patient
technology to improve coordination and management of care and
patient adherence to recommendations made by their provider);
and
``(3) a methodology for tracking prompt and timely access to
medically necessary care for children with medically complex
conditions from out-of-State providers.
``(g) Data Collection.--
``(1) Provider reporting requirements.--In order to receive
payments from a State under subsection (c), a designated
provider, a team of health care professionals operating with
such a provider, or a health team shall report to the State, at
such time and in such form and manner as may be required by the
State, the following information:
``(A) With respect to each such provider, team of
health care professionals, or health team, the name,
National Provider Identification number, address, and
specific health care services offered to be provided to
children with medically complex conditions who have
selected such provider, team of health care
professionals, or health team as the health home of such
children.
``(B) Information on all applicable measures for
determining the quality of health home services provided
by such provider, team of health care professionals, or
health team, including, to the extent applicable, child
health quality measures and measures for centers of
excellence for children with complex needs developed
under this title, title XXI, and section 1139A.
``(C) Such other information as the Secretary shall
specify in guidance.
When appropriate and feasible, such provider, team of health
care professionals, or health team, as the case may be, shall
use health information technology in providing the State with
such information.
``(2) State reporting requirements.--
``(A) Comprehensive report.--A State with a State
plan amendment approved under this section shall report
to the Secretary (and, upon request, to the Medicaid and
CHIP Payment and Access Commission), at such time and in
such form and manner determined by the Secretary to be
reasonable and minimally burdensome, the following
information:
``(i) Information reported under paragraph
(1).
``(ii) The number of children with medically
complex conditions who have selected a health home
pursuant to this section.
[[Page 133 STAT. 857]]
``(iii) The nature, number, and prevalence of
chronic conditions, life-threatening illnesses,
disabilities, or rare diseases that such children
have.
``(iv) The type of delivery systems and
payment models used to provide services to such
children under this section.
``(v) The number and characteristics of
designated providers, teams of health care
professionals operating with such providers, and
health teams selected as health homes pursuant to
this section, including the number and
characteristics of out-of-State providers, teams
of health care professionals operating with such
providers, and health teams who have provided
health care items and services to such children.
``(vi) The extent to which such children
receive health care items and services under the
State plan.
``(vii) Quality measures developed
specifically with respect to health care items and
services provided to children with medically
complex conditions.
``(B) <<NOTE: Public information. Web posting.>>
Report on best practices.--Not later than 90 days after
a State has a State plan amendment approved under this
section, such State shall submit to the Secretary, and
make publicly available on the appropriate State
website, a report on how the State is implementing
guidance issued under subsection (e)(1), including
through any best practices adopted by the State.
``(h) Rule of Construction.--Nothing in this section may be
construed--
``(1) to require a child with medically complex conditions
to enroll in a health home under this section;
``(2) to limit the choice of a child with medically complex
conditions in selecting a designated provider, team of health
care professionals operating with such a provider, or health
team that meets the health home qualification standards
established under subsection (b) as the child's health home; or
``(3) to reduce or otherwise modify--
``(A) the entitlement of children with medically
complex conditions to early and periodic screening,
diagnostic, and treatment services (as defined in
section 1905(r)); or
``(B) the informing, providing, arranging, and
reporting requirements of a State under section
1902(a)(43).
``(i) Definitions.--In this section:
``(1) Child with medically complex conditions.--
``(A) In general.--Subject to subparagraph (B), the
term `child with medically complex conditions' means an
individual under 21 years of age who--
``(i) is eligible for medical assistance under
the State plan (or under a waiver of such plan);
and
``(ii) has at least--
``(I) one or more chronic conditions
that cumulatively affect three or more
organ systems and severely reduces
cognitive or physical functioning (such
as the ability to eat, drink, or breathe
independently) and that also requires
the use of medication, durable medical
equipment, therapy, surgery, or other
treatments; or
[[Page 133 STAT. 858]]
``(II) one life-limiting illness or
rare pediatric disease (as defined in
section 529(a)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360ff(a)(3))).
``(B) Rule of construction.--Nothing in this
paragraph shall prevent the Secretary from establishing
higher levels as to the number or severity of chronic,
life threatening illnesses, disabilities, rare diseases
or mental health conditions for purposes of determining
eligibility for receipt of health home services under
this section.
``(2) Chronic condition.--The term `chronic condition' means
a serious, long-term physical, mental, or developmental
disability or disease, including the following:
``(A) Cerebral palsy.
``(B) Cystic fibrosis.
``(C) HIV/AIDS.
``(D) Blood diseases, such as anemia or sickle cell
disease.
``(E) Muscular dystrophy.
``(F) Spina bifida.
``(G) Epilepsy.
``(H) Severe autism spectrum disorder.
``(I) Serious emotional disturbance or serious
mental health illness.
``(3) Health home.--The term `health home' means a
designated provider (including a provider that operates in
coordination with a team of health care professionals) or a
health team selected by a child with medically complex
conditions (or the family of such child) to provide health home
services.
``(4) Health home services.--
``(A) In general.--The term `health home services'
means comprehensive and timely high-quality services
described in subparagraph (B) that are provided by a
designated provider, a team of health care professionals
operating with such a provider, or a health team.
``(B) Services described.--The services described in
this subparagraph shall include--
``(i) comprehensive care management;
``(ii) care coordination, health promotion,
and providing access to the full range of
pediatric specialty and subspecialty medical
services, including services from out-of-State
providers, as medically necessary;
``(iii) comprehensive transitional care,
including appropriate follow-up, from inpatient to
other settings;
``(iv) patient and family support (including
authorized representatives);
``(v) referrals to community and social
support services, if relevant; and
``(vi) use of health information technology to
link services, as feasible and appropriate.
``(5) Designated provider.--The term `designated provider'
means a physician (including a pediatrician or a pediatric
specialty or subspecialty provider), children's hospital,
clinical practice or clinical group practice, prepaid inpatient
health plan or prepaid ambulatory health plan (as defined by the
Secretary), rural clinic, community health center, community
mental health center, home health agency, or any other entity or
provider
[[Page 133 STAT. 859]]
that is determined by the State and approved by the Secretary to
be qualified to be a health home for children with medically
complex conditions on the basis of documentation evidencing that
the entity has the systems, expertise, and infrastructure in
place to provide health home services. Such term may include
providers who are employed by, or affiliated with, a children's
hospital.
``(6) Team of health care professionals.--The term `team of
health care professionals' means a team of health care
professionals (as described in the State plan amendment under
this section) that may--
``(A) include--
``(i) physicians and other professionals, such
as pediatricians or pediatric specialty or
subspecialty providers, nurse care coordinators,
dietitians, nutritionists, social workers,
behavioral health professionals, physical
therapists, occupational therapists, speech
pathologists, nurses, individuals with experience
in medical supportive technologies, or any
professionals determined to be appropriate by the
State and approved by the Secretary;
``(ii) an entity or individual who is
designated to coordinate such a team; and
``(iii) community health workers, translators,
and other individuals with culturally-appropriate
expertise; and
``(B) be freestanding, virtual, or based at a
children's hospital, hospital, community health center,
community mental health center, rural clinic, clinical
practice or clinical group practice, academic health
center, or any entity determined to be appropriate by
the State and approved by the Secretary.
``(7) Health team.--The term `health team' has the meaning
given such term for purposes of section 3502 of Public Law 111-
148.''.
SEC. 4. EXTENSION OF THE COMMUNITY MENTAL HEALTH SERVICES
DEMONSTRATION PROGRAM.
Section 223(d)(3) of the Protecting Access to Medicare Act of 2014
(42 U.S.C. 1396a note) is amended by striking ``for 2-year demonstration
programs under this subsection'' and inserting ``to conduct
demonstration programs under this subsection for 2 years or through June
30, 2019, whichever is longer''.
SEC. 5. ADDITIONAL FUNDING FOR THE MONEY FOLLOWS THE PERSON
REBALANCING DEMONSTRATION.
Section 6071(h)(1)(F) of the Deficit Reduction Act of 2005 (42
U.S.C. 1396a note) is amended by striking ``$112,000,000'' and inserting
``132,000,000''.
SEC. 6. PREVENTING THE MISCLASSIFICATION OF DRUGS UNDER THE
MEDICAID DRUG REBATE PROGRAM.
(a) Application of Civil Money Penalty for Misclassification of
Covered Outpatient Drugs.--
(1) In general.--Section 1927(b)(3) of the Social Security
Act (42 U.S.C. 1396r-8(b)(3)) is amended--
(A) in the paragraph heading, by inserting ``and
drug product'' after ``price'';
[[Page 133 STAT. 860]]
(B) in subparagraph (A)--
(i) in clause (ii), by striking ``; and'' at
the end and inserting a semicolon;
(ii) in clause (iii), by striking the period
at the end and inserting a semicolon;
(iii) in clause (iv), by striking the
semicolon at the end and inserting ``; and''; and
(iv) by inserting after clause (iv) the
following new clause:
``(v) <<NOTE: Deadline.>> not later than 30
days after the last day of each month of a rebate
period under the agreement, such drug product
information as the Secretary shall require for
each of the manufacturer's covered outpatient
drugs.''; and
(C) in subparagraph (C)--
(i) in clause (ii), by inserting ``, including
information related to drug pricing, drug product
information, and data related to drug pricing or
drug product information,'' after ``provides false
information'';
(ii) by adding at the end the following new
clauses:
``(iii) Misclassified drug product or
misreported information.--
``(I) <<NOTE: Penalties.>> In
general.--Any manufacturer with an
agreement under this section that
knowingly (as defined in section
1003.110 of title 42, Code of Federal
Regulations (or any successor
regulation)) misclassifies a covered
outpatient drug, such as by knowingly
submitting incorrect drug product
information, is subject to a civil money
penalty for each covered outpatient drug
that is misclassified in an amount not
to exceed 2 times the amount of the
difference between--
``(aa) the total amount of
rebates that the manufacturer
paid with respect to the drug to
all States for all rebate
periods during which the drug
was misclassified; and
``(bb) the total amount of
rebates that the manufacturer
would have been required to pay,
as determined by the Secretary
using drug product information
provided by the manufacturer,
with respect to the drug to all
States for all rebate periods
during which the drug was
misclassified if the drug had
been correctly classified.
``(II) Other penalties and recovery
of underpaid rebates.--The civil money
penalties described in subclause (I) are
in addition to other penalties as may be
prescribed by law and any other recovery
of the underlying underpayment for
rebates due under this section or the
terms of the rebate agreement as
determined by the Secretary.
``(iv) Increasing oversight and enforcement.--
Each year the Secretary shall retain, in addition
to any amount retained by the Secretary to recoup
investigation and litigation costs related to the
enforcement of the civil money penalties under
this subparagraph
[[Page 133 STAT. 861]]
and subsection (c)(4)(B)(ii)(III), an amount equal
to 25 percent of the total amount of civil money
penalties collected under this subparagraph and
subsection (c)(4)(B)(ii)(III) for the year, and
such retained amount shall be available to the
Secretary, without further appropriation and until
expended, for activities related to the oversight
and enforcement of this section and agreements
under this section, including--
``(I) improving drug data reporting
systems;
``(II) evaluating and ensuring
manufacturer compliance with rebate
obligations; and
``(III) oversight and enforcement
related to ensuring that manufacturers
accurately and fully report drug
information, including data related to
drug classification.''; and
(iii) in subparagraph (D)--
(I) in clause (iv), by striking ``,
and'' and inserting a comma;
(II) in clause (v), by striking the
period and inserting ``, and''; and
(III) by inserting after clause (v)
the following new clause:
``(vi) in the case of categories of drug
product or classification information that were
not considered confidential by the Secretary on
the day before the date of the enactment of this
clause.''.
(2) Technical amendments.--
(A) Section 1903(i)(10) of the Social Security Act
(42 U.S.C. 1396b(i)(10)) is amended--
(i) in subparagraph (C)--
(I) by adjusting the left margin so
as to align with the left margin of
subparagraph (B); and
(II) by striking ``, and'' and
inserting a semicolon;
(ii) in subparagraph (D), by striking ``; or''
and inserting ``; and''; and
(iii) by adding at the end the following new
subparagraph:
``(E) with respect to any amount expended for a covered
outpatient drug for which a suspension under section
1927(c)(4)(B)(ii)(II) is in effect; or''.
(B) Section 1927(b)(3)(C)(ii) of the Social Security
Act (42 U.S.C. 1396r-8(b)(3)(C)(ii)) is amended by
striking ``subsections (a) and (b)'' and inserting
``subsections (a), (b), (f)(3), and (f)(4)''.
(b) Recovery of Unpaid Rebate Amounts Due to Misclassification of
Covered Outpatient Drugs.--
(1) In general.--Section 1927(c) of the Social Security Act
(42 U.S.C. 1396r-8(c)) is amended by adding at the end the
following new paragraph:
``(4) Recovery of unpaid rebate amounts due to
misclassification of covered outpatient drugs.--
``(A) <<NOTE: Determination.>> In general.--If the
Secretary determines that a manufacturer with an
agreement under this section paid a lower per-unit
rebate amount to a State for a rebate period as a result
of the misclassification by the manufacturer of a
covered outpatient drug (without regard to
[[Page 133 STAT. 862]]
whether the manufacturer knowingly made the
misclassification or should have known that the
misclassification would be made) than the per-unit
rebate amount that the manufacturer would have paid to
the State if the drug had been correctly classified, the
manufacturer shall pay to the State an amount equal to
the product of--
``(i) the difference between--
``(I) the per-unit rebate amount
paid to the State for the period; and
``(II) the per-unit rebate amount
that the manufacturer would have paid to
the State for the period, as determined
by the Secretary, if the drug had been
correctly classified; and
``(ii) the total units of the drug paid for
under the State plan in the period.
``(B) Authority to correct misclassifications.--
``(i) <<NOTE: Determination. Notification.>>
In general.--If the Secretary determines that a
manufacturer with an agreement under this section
has misclassified a covered outpatient drug
(without regard to whether the manufacturer
knowingly made the misclassification or should
have known that the misclassification would be
made), the Secretary shall notify the manufacturer
of the misclassification and require the
manufacturer to correct the misclassification in a
timely manner.
``(ii) Enforcement.--If, after receiving
notice of a misclassification from the Secretary
under clause (i), a manufacturer fails to correct
the misclassification by such time as the
Secretary shall require, until the manufacturer
makes such correction, the Secretary may do any or
all of the following:
``(I) Correct the misclassification,
using drug product information provided
by the manufacturer, on behalf of the
manufacturer.
``(II) Suspend the misclassified
drug and the drug's status as a covered
outpatient drug under the manufacturer's
national rebate agreement, and exclude
the misclassified drug from Federal
financial participation in accordance
with section 1903(i)(10)(E).
``(III) <<NOTE: Penalties.>> Impose
a civil money penalty (which shall be in
addition to any other recovery or
penalty which may be available under
this section or any other provision of
law) for each rebate period during which
the drug is misclassified not to exceed
an amount equal to the product of--
``(aa) the total number of
units of each dosage form and
strength of such misclassified
drug paid for under any State
plan during such a rebate
period; and
``(bb) 23.1 percent of the
average manufacturer price for
the dosage form and strength of
such misclassified drug.
``(C) Reporting and transparency.--
``(i) In general.--The Secretary shall submit
a report to Congress on at least an annual basis
that
[[Page 133 STAT. 863]]
includes information on the covered outpatient
drugs that have been identified as misclassified,
any steps taken to reclassify such drugs, the
actions the Secretary has taken to ensure the
payment of any rebate amounts which were unpaid as
a result of such misclassification, and a
disclosure of expenditures from the fund created
in subsection (b)(3)(C)(iv), including an
accounting of how such funds have been allocated
and spent in accordance with such subsection.
``(ii) Public access.--The Secretary shall
make the information contained in the report
required under clause (i) available to the public
on a timely basis.
``(D) Other penalties and actions.--Actions taken
and penalties imposed under this clause shall be in
addition to other remedies available to the Secretary
including terminating the manufacturer's rebate
agreement for noncompliance with the terms of such
agreement and shall not exempt a manufacturer from, or
preclude the Secretary from pursuing, any civil money
penalty under this title or title XI, or any other
penalty or action as may be prescribed by law.''.
(2) Offset of recovered amounts against medical
assistance.--Section 1927(b)(1)(B) of the Social Security Act
(42 U.S.C. 1396r-8(b)(1)(B)) is amended by inserting ``,
including amounts received by a State under subsection (c)(4),''
after ``in any quarter''.
(c) Clarifying Definitions.--Section 1927(k) of the Social Security
Act (42 U.S.C. 1396r-8(k)) is amended--
(1) in paragraph (2)(A), by striking ``paragraph (5)'' and
inserting ``paragraph (4)''; and
(2) in paragraph (7)(A)--
(A) by striking ``an original new drug application''
and inserting ``a new drug application'' each place it
appears;
(B) in clause (i), by striking ``(not including any
drug described in paragraph (5))'' and inserting ``,
including a drug product approved for marketing as a
non-prescription drug that is regarded as a covered
outpatient drug under paragraph (4),'';
(C) in clause (ii)--
(i) by striking ``was originally marketed''
and inserting ``is marketed''; and
(ii) by inserting ``, unless the Secretary
determines that a narrow exception applies (as
described in section 447.502 of title 42, Code of
Federal Regulations (or any successor
regulation))'' before the period; and
(D) in clause (iv)--
(i) by inserting ``, including a drug product
approved for marketing as a non-prescription drug
that is regarded as a covered outpatient drug
under paragraph (4),'' after ``covered outpatient
drug'';
(ii) by inserting ``unless the Secretary
determines that a narrow exception applies (as
described in section 447.502 of title 42, Code of
Federal Regulations (or any successor
regulation))'' after ``under the new drug
application''; and
(iii) by adding at the end the following new
sentence: ``Such term also includes a covered
outpatient
[[Page 133 STAT. 864]]
drug that is a biological product licensed,
produced, or distributed under a biologics license
application approved by the Food and Drug
Administration.''.
(d) Exclusion of Manufacturers for Knowing Misclassification of
Covered Outpatient Drugs.--Section 1128(b) of the Social Security Act
(42 U.S.C. 1320a-7(b)) is amended by adding at the end the following new
paragraph:
``(17) Knowingly misclassifying covered outpatient drugs.--
Any manufacturer or officer, director, agent, or managing
employee of such manufacturer that knowingly misclassifies a
covered outpatient drug under an agreement under section 1927,
knowingly fails to correct such misclassification, or knowingly
provides false information related to drug pricing, drug product
information, or data related to drug pricing or drug product
information.''.
(e) <<NOTE: 42 USC 1320a-7 note.>> Effective Date.--The amendments
made by this section shall take effect on the date of the enactment of
this Act, and shall apply to covered outpatient drugs supplied by
manufacturers under agreements under section 1927 of the Social Security
Act (42 U.S.C. 1396r-8) on or after such date.
SEC. 7. EXTENSION OF THIRD-PARTY LIABILITY PERIOD FOR CHILD
SUPPORT SERVICES.
(a) In General.--Section 202(a)(2) of the Bipartisan Budget Act of
2013 (Public Law 113-67) is amended by striking ``90 days'' and
inserting ``100 days''.
(b) <<NOTE: 42 USC 1396a note.>> Effective Date.--The amendment
made by this section shall take effect on the date of the enactment of
this Act.
SEC. 8. DENIAL OF FFP FOR CERTAIN EXPENDITURES RELATING TO VACUUM
ERECTION SYSTEMS AND PENILE PROSTHETIC
IMPLANTS.
(a) In General.--Section 1903(i) of the Social Security Act (42
U.S.C. 1396b(i)) is amended by inserting after paragraph (11) the
following:
``(12) with respect to any amounts expended for--
``(A) a vacuum erection system that is not medically
necessary; or
``(B) the insertion, repair, or removal and
replacement of a penile prosthetic implant (unless such
insertion, repair, or removal and replacement is
medically necessary); or''.
(b) <<NOTE: 42 USC 1396b note.>> Effective Date.--The amendment
made by subsection (a) shall apply with respect to items and services
furnished on or after January 1, 2020.
SEC. 9. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of complying with
the Statutory Pay-As-You-Go Act of 2010, shall be determined by
reference to the latest statement titled ``Budgetary Effects of PAYGO
Legislation'' for this Act, submitted for printing in the
[[Page 133 STAT. 865]]
Congressional Record by the Chairman of the House Budget Committee,
provided that such statement has been submitted prior to the vote on
passage.
Approved April 18, 2019.
LEGISLATIVE HISTORY--H.R. 1839:
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CONGRESSIONAL RECORD, Vol. 165 (2019):
Mar. 25, considered and passed House.
Apr. 2, considered and passed Senate.
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