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‘‘(iii) comprehensive transitional care, 
including appropriate follow-up, from inpa-
tient to other settings; 
‘‘(iv) patient and family support (in-
cluding authorized representatives); 
‘‘(v) referrals to community and social 
support services, if relevant; and 
‘‘(vi) use of health information tech-
nology to link services, as feasible and ap-
propriate. 
‘‘(5) DESIGNATED PROVIDER.—The term ‘des-
ignated provider’ means a physician (including a pe-
diatrician 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 agen-
cy, or any other entity or provider that is deter-
mined 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 docu-
mentation evidencing that the entity has the sys-
tems, expertise, and infrastructure in place to pro-
vide health home services. Such term may include 
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providers who are employed by, or affiliated with, a 
children’s hospital. 
‘‘(6) 
TEAM
OF
HEALTH
CARE
PROFES-
SIONALS.—The term ‘team of health care profes-
sionals’ 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 profes-
sionals, such as pediatricians or pediatric 
specialty or subspecialty providers, nurse 
care coordinators, dietitians, nutritionists, 
social workers, behavioral health profes-
sionals, physical therapists, occupational 
therapists, speech pathologists, nurses, in-
dividuals with experience in medical sup-
portive 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 cul-
turally-appropriate expertise; and 
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‘‘(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 Medi-
care 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 pro-
grams 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 DEMONSTRA-
TION. 
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’’. 
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SEC. 6. PREVENTING THE MISCLASSIFICATION OF DRUGS 
UNDER THE MEDICAID DRUG REBATE PRO-
GRAM. 
(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 pe-
riod 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 
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for each of the manufacturer’s covered out-
patient drugs.’’; and 
(C) in subparagraph (C)— 
(i) in clause (ii), by inserting ‘‘, in-
cluding information related to drug pric-
ing, drug product information, and data 
related to drug pricing or drug product in-
formation,’’ after ‘‘provides false informa-
tion’’; 
(ii) by adding at the end the following 
new clauses: 
‘‘(iii) MISCLASSIFIED DRUG PRODUCT 
OR MISREPORTED INFORMATION.— 
‘‘(I) IN
GENERAL.—Any manu-
facturer 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 in-
formation, is subject to a civil money 
penalty for each covered outpatient 
drug that is misclassified in an 
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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 dur-
ing 
which 
the 
drug 
was 
misclassified if the drug had been 
correctly classified. 
‘‘(II) OTHER
PENALTIES
AND 
RECOVERY
OF
UNDERPAID
RE-
BATES.—The civil money penalties de-
scribed in subclause (I) are in addi-
tion to other penalties as may be pre-
scribed by law and any other recovery 
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of the underlying underpayment for 
rebates due under this section or the 
terms of the rebate agreement as de-
termined by the Secretary. 
‘‘(iv) INCREASING
OVERSIGHT
AND 
ENFORCEMENT.—Each year the Secretary 
shall retain, in addition to any amount re-
tained by the Secretary to recoup inves-
tigation 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 ac-
tivities related to the oversight and en-
forcement of this section and agreements 
under this section, including— 
‘‘(I) improving drug data report-
ing systems; 
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‘‘(II) evaluating and ensuring 
manufacturer compliance with rebate 
obligations; and 
‘‘(III) oversight and enforcement 
related to ensuring that manufactur-
ers 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 Secu-
rity Act (42 U.S.C. 1396b(i)(10)) is amended— 
(i) in subparagraph (C)— 
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(I) by adjusting the left margin 
so as to align with the left margin of 
subparagraph (B); and 
(II) by striking ‘‘, and’’ and in-
serting a semicolon; 
(ii) in subparagraph (D), by striking 
‘‘; or’’ and inserting ‘‘; and’’; and 
(iii) by adding at the end the fol-
lowing 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 So-
cial Security Act (42 U.S.C. 1396r–8(c)) is amended 
by adding at the end the following new paragraph: 
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‘‘(4) RECOVERY OF UNPAID REBATE AMOUNTS 
DUE
TO
MISCLASSIFICATION
OF
COVERED
OUT-
PATIENT DRUGS.— 
‘‘(A) IN GENERAL.—If the Secretary deter-
mines 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 re-
sult of the misclassification by the manufac-
turer of a covered outpatient drug (without re-
gard 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 man-
ufacturer 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 
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‘‘(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 manufac-
turer knowingly made the misclassification 
or 
should 
have 
known 
that 
the 
misclassification would be made), the Sec-
retary shall notify the manufacturer of the 
misclassification and require the manufac-
turer to correct the misclassification in a 
timely manner. 
‘‘(ii) ENFORCEMENT.—If, after receiv-
ing 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 correc-
tion, the Secretary may do any or all of 
the following: 
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‘‘(I) Correct the misclassification, 
using drug product information pro-
vided by the manufacturer, on behalf 
of the manufacturer. 
‘‘(II) Suspend the misclassified 
drug and the drug’s status as a cov-
ered outpatient drug under the manu-
facturer’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 pen-
alty (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 
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plan during such a rebate period; 
and 
‘‘(bb) 23.1 percent of the av-
erage 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 infor-
mation 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 en-
sure the payment of any rebate amounts 
which were unpaid as a result of such 
misclassification, and a disclosure of ex-
penditures from the fund created in sub-
section (b)(3)(C)(iv), including an account-
ing of how such funds have been allocated 
and spent in accordance with such sub-
section. 
‘‘(ii) PUBLIC ACCESS.—The Secretary 
shall make the information contained in 
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the report required under clause (i) avail-
able 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 pre-
scribed 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 amend-
ed— 
(1) in paragraph (2)(A), by striking ‘‘paragraph 
(5)’’ and inserting ‘‘paragraph (4)’’; and 
(2) in paragraph (7)(A)— 
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(A) by striking ‘‘an original new drug ap-
plication’’ and inserting ‘‘a new drug applica-
tion’’ each place it appears; 
(B) in clause (i), by striking ‘‘(not includ-
ing 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 mar-
keted’’ and inserting ‘‘is marketed’’; and 
(ii) by inserting ‘‘, unless the Sec-
retary 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 pe-
riod; 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’’; 
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(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 fol-
lowing new sentence: ‘‘Such term also in-
cludes a covered outpatient drug that is a 
biological product licensed, produced, or 
distributed under a biologics license appli-
cation approved by the Food and Drug Ad-
ministration.’’. 
(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 man-
ufacturer that knowingly misclassifies a covered out-
patient drug under an agreement under section 
1927, 
knowingly 
fails 
to 
correct 
such 
misclassification, or knowingly provides false infor-
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mation related to drug pricing, drug product infor-
mation, 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 sec-
tion 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 Bipar-
tisan Budget Act of 2013 (Public Law 113–67) is amend-
ed 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 RE-
LATING TO VACUUM ERECTION SYSTEMS 
AND PENILE PROSTHETIC IMPLANTS. 
(a) IN GENERAL.—Section 1903(i) of the Social Se-
curity Act (42 U.S.C. 1396b(i)) is amended by inserting 
after paragraph (11) the following: 
‘‘(12) with respect to any amounts expended 
for— 
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‘‘(A) a vacuum erection system that is not 
medically necessary; or 
‘‘(B) the insertion, repair, or removal and 
replacement of a penile prosthetic implant (un-
less such insertion, repair, or removal and re-
placement is medically necessary); or’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to items and serv-
ices 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, pro-
vided that such statement has been submitted prior to the 
vote on passage. 
Passed the House of Representatives March 25, 
2019. 
Attest: 
CHERYL L. JOHNSON, 
Clerk. 
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