[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1839 Enrolled Bill (ENR)]
H.R.1839
One Hundred Sixteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and nineteen
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``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) 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)) 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. STATE OPTION TO PROVIDE COORDINATED CARE THROUGH A HEALTH
HOME FOR CHILDREN WITH MEDICALLY COMPLEX CONDITIONS.
``(a) 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) 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
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) 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.--
``(1) 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) 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) 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, 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) 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) 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.
``(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) 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
``(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 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'';
(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) 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) 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 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) 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 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) 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) 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 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 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) 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) 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) 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 Congressional
Record by the Chairman of the House Budget Committee, provided that
such statement has been submitted prior to the vote on passage.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.