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 commu-
nity-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
DIS-
REGARD 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))
H. R. 1839—2 
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 sup-
ports 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 COM-
PLEX 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 MEDI-
CALLY COMPLEX CONDITIONS. 
‘‘(a) IN GENERAL.—Notwithstanding section 1902(a)(1) (relating 
to statewideness) and section 1902(a)(10)(B) (relating to com-
parability), 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 des-
ignated 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 serv-
ices 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
H. R. 1839—3 
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 pro-
vider, 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 profes-
sionals, or health team as the child’s health home. Payments 
made to a designated provider, a team of health care profes-
sionals 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 serv-
ices. 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 method-
ology 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 Sec-
retary 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 plan-
ning 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.—
H. R. 1839—4 
‘‘(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 edu-
cating 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 oper-
ating such a provider, or health team for the purpose of estab-
lishing a health home through which such children may receive 
such services. 
‘‘(3) FAMILY EDUCATION.—In order for a State plan amend-
ment 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 avail-
ability of health care items and services to families of individ-
uals 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 pro-
viders 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,
H. R. 1839—5 
hospitals, pediatricians, and other providers), managed care 
plans, children’s health groups, family and beneficiary advo-
cates, 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 des-
ignated 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 medi-
cally 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 deter-
mining 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 com-
plex conditions who have selected a health home pursu-
ant to this section.
H. R. 1839—6 
‘‘(iii) The nature, number, and prevalence of 
chronic conditions, life-threatening illnesses, disabil-
ities, 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 guid-
ance 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 estab-
lished 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 func-
tioning (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
H. R. 1839—7 
‘‘(II) one life-limiting illness or rare pediatric 
disease (as defined in section 529(a)(3) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff(a)(3))). 
‘‘(B) RULE OF CONSTRUCTION.—Nothing in this para-
graph shall prevent the Secretary from establishing higher 
levels as to the number or severity of chronic, life threat-
ening 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 dis-
ease. 
‘‘(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 des-
ignated provider (including a provider that operates in coordina-
tion 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 des-
ignated provider, a team of health care professionals oper-
ating 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 pro-
viding 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 author-
ized representatives); 
‘‘(v) referrals to community and social support serv-
ices, 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 spe-
cialty or subspecialty provider), children’s hospital, clinical prac-
tice 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
H. R. 1839—8 
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 pro-
viders, nurse care coordinators, dietitians, nutrition-
ists, 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 clin-
ical 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’’;
H. R. 1839—9 
(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 out-
patient drugs.’’; and 
(C) in subparagraph (C)— 
(i) in clause (ii), by inserting ‘‘, including informa-
tion 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 Sec-
retary. 
‘‘(iv) INCREASING OVERSIGHT AND ENFORCEMENT.— 
Each year the Secretary shall retain, in addition to 
any amount retained by the Secretary to recoup inves-
tigation and litigation costs related to the enforcement 
of the civil money penalties under this subparagraph
H. R. 1839—10 
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 con-
fidential 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 semi-
colon; 
(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 ‘‘sub-
sections (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 manufac-
turer of a covered outpatient drug (without regard to
H. R. 1839—12 
includes information on the covered outpatient drugs 
that have been identified as misclassified, any steps 
taken to reclassify such drugs, the actions the Sec-
retary 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 non-
compliance 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 para-
graph (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 sen-
tence: ‘‘Such term also includes a covered outpatient
H. R. 1839—13 
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 man-
aging 
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
H. R. 1839—14 
Congressional Record by the Chairman of the House Budget Com-
mittee, 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.