(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’’;
(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-
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—
‘‘(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: 
Clerk.
116TH CONGRESS 
1ST SESSION 
H. R. 1839 
AN ACT 
To amend title XIX to extend protection for Med-
icaid recipients of home and community-based 
services against spousal impoverishment, estab-
lish a State Medicaid option to provide coordi-
nated care to children with complex medical con-
ditions through health homes, prevent the 
misclassification of drugs for purposes of the 
Medicaid drug rebate program, and for other 
purposes.