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(B) the value of collecting such informa-
tion by small home health agencies compared to 
the administrative burden related to such collec-
tion. 
In conducting the study the Secretary shall obtain 
recommendations from quality assessment experts in 
the use of such information and the necessity of 
small, as well as large, home health agencies col-
lecting such information. 
(2) REPORT.—The Secretary shall submit to 
Congress a report on the study conducted under 
paragraph (1) by not later than 18 months after the 
date of the enactment of this Act. 
(d) CONSTRUCTION.—Nothing in this section shall be 
construed as preventing home health agencies from col-
lecting non-medicare/medicaid OASIS information for 
their own use. 
TITLE X—MEDICAID 
SEC. 1001. MEDICAID DISPROPORTIONATE SHARE HOS-
PITAL (DSH) PAYMENTS. 
Section 1923(f)(3) (42 U.S.C. 1396r–4(f)(3)) is 
amended—
(1) in subparagraph (A), by striking ‘‘subpara-
graph (B)’’ and inserting ‘‘subparagraphs (B) and 
(C)’’; and
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(2) by adding at the end the following new sub-
paragraphs: 
‘‘(C) SPECIAL, TEMPORARY INCREASE IN 
ALLOTMENTS
ON
A
ONE-TIME, NON-CUMU-
LATIVE
BASIS.—The DSH allotment for any 
State—
‘‘(i) for fiscal year 2004 is equal to 
120 percent of the DSH allotment for the 
State for fiscal year 2003 under this para-
graph, notwithstanding subparagraph (B); 
and 
‘‘(ii) for each succeeding fiscal year is 
equal to the DSH allotment for the State 
for fiscal year 2004 or, in the case of fiscal 
years beginning with the fiscal year speci-
fied in subparagraph (D) for that State, 
the percentage change in the consumer 
price index for all urban consumers (all 
items; U.S. city average), for the previous 
fiscal year. 
‘‘(D) FISCAL YEAR SPECIFIED.—For pur-
poses of subparagraph (C)(ii), the fiscal year 
specified in this subparagraph for a State is the 
first fiscal year for which the Secretary esti-
mates that the DSH allotment for that State
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will equal (or no longer exceed) the DSH allot-
ment for that State under the law as in effect 
before the date of the enactment of this sub-
paragraph.’’. 
SEC. 1002. CLARIFICATION OF INCLUSION OF INPATIENT 
DRUG PRICES CHARGED TO CERTAIN PUBLIC 
HOSPITALS IN THE BEST PRICE EXEMPTIONS 
FOR THE MEDICAID DRUG REBATE PRO-
GRAM. 
(a) IN GENERAL.—Section 1927(c)(1)(C)(i)(I) (42 
U.S.C. 1396r–8(c)(1)(C)(i)(I)) is amended by inserting 
before the semicolon the following: ‘‘(including inpatient 
prices 
charged 
to 
hospitals 
described 
in 
section 
340B(a)(4)(L) of the Public Health Service Act)’’. 
(b) 
ANTI-DIVERSION
PROTECTION.—Section 
1927(c)(1)(C) (42 U.S.C. 1396r–8(c)(1)(C)) is amended 
by adding at the end the following: 
‘‘(iii) APPLICATION OF AUDITING AND 
RECORDKEEPING
REQUIREMENTS.—With 
respect to a covered entity described in 
section 340B(a)(4)(L) of the Public Health 
Service Act, any drug purchased for inpa-
tient use shall be subject to the auditing 
and recordkeeping requirements described
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in section 340B(a)(5)(C) of the Public 
Health Service Act.’’.
TITLE XI—ACCESS TO AFFORD-
ABLE PHARMACEUTICALS 
Subtitle A—Access to Affordable 
Pharmaceuticals 
SEC. 1101. 30-MONTH STAY-OF-EFFECTIVENESS PERIOD. 
(a) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) is amended— 
(1) in paragraph (2)—
(A) by striking subparagraph (B) and in-
serting the following: 
‘‘(B) NOTICE OF OPINION THAT PATENT IS INVALID 
OR WILL NOT BE INFRINGED.—
‘‘(i) AGREEMENT TO GIVE NOTICE.—An appli-
cant that makes a certification described in subpara-
graph (A)(vii)(IV) shall include in the application a 
statement that the applicant will give notice as re-
quired by this subparagraph. 
‘‘(ii) TIMING OF NOTICE.—An applicant that 
makes a certification described in subparagraph 
(A)(vii)(IV) shall give notice as required under this 
subparagraph—
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‘‘(I) if the certification is in the applica-
tion, not later than 20 days after the date of 
the postmark on the notice with which the Sec-
retary informs the applicant that the applica-
tion has been filed; or 
‘‘(II) if the certification is in an amend-
ment or supplement to the application, at the 
time at which the applicant submits the amend-
ment or supplement, regardless of whether the 
applicant has already given notice with respect 
to another such certification contained in the 
application or in an amendment or supplement 
to the application. 
‘‘(iii) RECIPIENTS
OF
NOTICE.—An applicant 
required under this subparagraph to give notice shall 
give notice to—
‘‘(I) each owner of the patent that is the 
subject of the certification (or a representative 
of the owner designated to receive such a no-
tice); and 
‘‘(II) the holder of the approved applica-
tion under subsection (b) for the drug that is 
claimed by the patent or a use of which is 
claimed by the patent (or a representative of 
the holder designated to receive such a notice).