A bill to amend title XIX of the Social Security Act to provide additional funds for the qualifying individual (QI) program, and for other purposes

2008·0.51 MB·English

by  United States. Congress. House

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110t2hdcSoesnsgironess H. R. 7077
ToamendtitleXIXoftheSocialSecuritySystemtoprovideadditional
fundsforthequalifyingindividual(QI)program,andforotherpurposes.
IN THE HOUSE OF REPRESENTATIVES
September25,2008
Mr. DiNGBLLintroducedthefollowingbill;whichwasreferredtotheCom-
mitteeonEnergyandCommerce,andinadditiontotheCommitteeon
Ways and Means, for aperiod to be subsequently determined by the
Speaker,ineachcaseforconsiderationofsuchprovisionsasfallwithin
thejurisdictionofthecommitteeconcerned
A
BILL
ToamendtitleXIXofthe Social SecuritySystemtoprovide
additional fimds for the quahfying individual (QI) pro-
gram,andforotherpurposes.
1 BeitenactedbytheSenateandHouseofRepresenta-
2 tivesoftheUnitedStatesofAmericainCongressassembled,
3 SECTION1.SHORTTITLE.
4 ThisActmaybe cited asthe "QI Program Supple-
5 mentalFundingActof2008".
2
1 SEC. 2. FUNDING FORTHE QUALIFYING INDIVIDUAL (QI)
2 PROGRAM.
3 Section 1933(g)(2) of the Social Security Act (42
4 U.S.C. 1396u-3(g)(2)), as amendedbysection 111(b) of
5 the Medicare Improvements for Patients and Providers
6 Actof2008(PubhcLaw110-275),isamended—
7 (1) in subparagraph (I), by striking
8 "$300,000,000" andinserting "$315,000,000"; and
9 (2) in subparagraph (J), by striking
10 "$100,000,000"andinserting"$130,000,000".
11 SEC. 3. MANDATORYUSE OF STATE PUBLIC ASSISTANCE
12 REPORTING INFORMATION SYSTEM (PARIS)
13 PROJECT.
—
14 (a) InGeneral. Section 1903(r) ofthe Social Se-
15 curityAct(42U.S.C.1396b(r))isamended—
16 (1) in paragraph (1), in the matter preceding
17 subparagraph (A), by inserting ", in addition to
18 meeting the requirements of paragraph (3)," after
19 "aStatemust";and
20 (2) by adding at the end the following new
21 paragraph:
22 "(3) Inordertomeettherequirementsofthispara-
23 graph, aStatemusthaveinoperationanehgibihtydeter-
24 mination system which provides for data matching
25 throughthePubhcAssistanceReportingInformationSys-
26 tem (PARIS) facihtated by the Secretary (or any suc-
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1 cessor system), including matching with medical assist-
2 anceprogramsoperatedbyotherStates.".
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3 (b)EffectiveDate.
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4 (1) In general. Except as pro\ided in para-
5 graph (2), the amendments made by subsection (a)
6 takeeffectonOctober1,2009.
7 (2) Extension of effective date for
—
8 state law amendment. In the case of a State
9 planundertitleXIXofthe Social SecurityAct (42
10 U.S.C. 1396 et seq.) whichthe SecretaryofHealth
11 andHumanServicesdeterminesrequiresStatelegis-
12 lation in order for the plan to meet the additional
13 requirements imposed by the amendments made by
14 subsection (a), the State plan shall notbe regarded
15 as faihng to complywith the requirements of such
16 title solely on the basis ofits failure to meet these
17 additional requirements before the first day of the
18 first calendar quarter beginning after the close of
19 thefirstregularsessionofthe Statelegislaturethat
20 begins after the date ofenactment ofthisAct. For
21 purposes ofthe previous sentence, in the case ofa
22 Statethathasa2-yearlegislative session, eachyear
23 ofthe sessionisconsideredtobe a separate regular
24 sessionoftheStatelegislature.
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4
1 SEC.4.INCENTIVESFORTHEDEVELOPMENTOF,ANDAC-
2 CESSTO,CERTAINANTIBIOTICS.
—
3 (a)InGeneral. Section505oftheFederalFood,
4 Drug, andCosmeticAct (21 U.S.C. 355) is amendedby
5 addingattheendthefollowing:
6 ''(v) Antibiotic Drugs Submitted Before No-
7 VEMBER21, 1997.
8 "(1) Antibiotic drugs approved before
9 november21, 1997.
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10 "(A) In GENERAL. Notwithstanding any
11 provisionofthe FoodandDrugAdministration
12 Modernization Act of 1997 or anyother provi-
13 sionoflaw,asponsorofadrugthatisthesub-
14 jectofanapplicationdescribedinsubparagraph
15 (B)(i) shall be ehgible for, with respect to the
16 drug, the 3-year exclusi\dty period referred to
17 under clauses (iii) and (iv) of subsection
18 (c)(3)(E) and under clauses (iii) and (iv) of
19 subsection (j)(5)(F), subject to the require-
20 mentsofsuchclauses,asapphcable.
21 "(B) APPLICATION; ANTIBIOTIC DRUG DE-
22 SCRIBED.
—
23 "(i) Application. ^An appheation
24 described in this clause is an appheation
25 ^ formarketingsubmittedunderthissection
26 afterthedateoftheenactmentofthissub-
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1 section inwhich the drugthat is the sub-
2 ject of the appheation contains an anti-
3 bioticdrugdescribedinclause(ii).
—
4 "(ii) Antibiotic drug. ^An anti-
5 biotic drug described in this clause is an
6 antibiotic drugthatwas the subject ofan
7 application approved by the Secretary
8 under section 507 ofthisAct (as ineffect
9 beforeNovember21, 1997).
10 "(2) Antibiotic drugs submitted before
11 november21, 1997,butnotapproved.
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12 "(A) In GENERAL. Notwithstanding any
13 pro\'ision oftheFoodandDrugAdministration
14 ModernizationAct of 1997 or any other provi-
15 sionoflaw,asponsorofadrugthatisthesub-
16 jectofanappheationdescribedinsubparagraph
17 (B)(i) mayelect to be ehgible for, with respect
18 tothedrug
19 "(i)(I)the3-yearexclusivityperiodre-
20 ferred to under clauses (iii) and (iv) of
21 subsection (c)(3)(E) andunderclauses (iii)
22 and (iv) ofsubsection (j)(5)(F), subject to
23 the requirements ofsuch clauses, as appU-
24 cable;and
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1 "(H) the 5-year exclusivityperiod re-
2 ferred to under clause (ii) of subsection
3 (c)(3)(E) and under clause (ii) of sub-
4 section (j)(5)(F\ subject to the require-
5 mentsofsuchclauses,asapphcable;or
6 '*(ii) a patent term extension under
7 section 156 of title 35, United States
8 Code, subject to the requirements of such
9 section.
10 "(B) Application; antibiotic drug de-
—
11 scribed.
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12 "(i) Application. ^An apphcation
13 described in this clause is an application
14 formarketingsubmittedunderthis section
15 afterthedateoftheenactmentofthissub-
16 section inwhich the drugthat is the sub-
17 ject of the apphcation contains an anti-
18 bioticdrugdescribedinclause(ii).
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19 "(ii) Antibiotic drug. ^An anti-
20 biotic drug described in this clause is an
21 antibioticdrugthatwasthesubjectof1 or
22 moreapphcationsreceivedbytheSecretary
23 under section 507 ofthisAct (as in effect
24 beforeNovember 21, 1997), none ofwhich
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1 was approvedbythe Secretaryunder such
2 section.
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3 "(3)Limitations.
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4 "(A) Exclusivities and extensions.
5 Paragraphs (1)(A) and (2)(A) shallnotbeeon-
6 strued to entitle a drug that is the subject of
7 an approved apphcation described in subpara-
8 graphs (l)(B)(i) or (2)(B)(i), as appUcable, to
9 any market exclusivities or patent extensions
10 other than those exclusivities or extensions de-
ll scribedinparagraph(1)(A)or(2)(A).
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12 "(B) Conditions of use. Paragraphs
13 (1)(A) and (2)(A)(i) shallnotapplytoanycon-
14 dition ofuse forwhich the drug referred to in
15 subparagraph (l)(B)(i) or (2)(B)(i), as apphca-
16 ble, was approvedbeforethe date ofthe enact-
17 mentofthissubsection.
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18 "(4) Application of certain provisions.
19 Notwithstandingsection 125, oranyotherprovision,
20 oftheFoodandDrugAdministrationModernization
21 Actof1997, oranyotherprovisionoflaw, andsub-
22 ject to the hmitations in paragraphs (1), (2), and
23 (3), the provisions of the Drug Price Competition
24 and Patent Term Restoration Act of 1984 shall
25 apply to an}^ drug subject to paragraph (1) or any
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1 drugwithrespecttowhichanelectionismadeunder
2 paragraph(2)(A).".
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3 (b)TransitionalRules.
4 (1)Withrespecttoapatentissuedonorbefore
5 thedateoftheenactmentofthisAct, anypatentin-
6 formation required to be filedwith the Secretaryof
7 HealthandHuman Servicesundersubsection (b)(1)
8 or (c)(2) ofsection 505 ofthe FederalFood, Drug,
9 andCosmeticAct (21 U.S.C. 355) tobehstedona
10 drugtowhich subsection (v)(l) ofsuch section 505
11 (as addedbythis section) apphes shaUbefiledwith
12 the Secretarynot later than 60 days afterthe date
13 oftheenactmentofthisAct.
14 (2) With respect to anypatent information re-
15 ferredto in paragraph (1) ofthis subsectionthatis
16 filed with the Secretarj^ within the 60-day period
17 afterthedateoftheenactmentofthisAct,theSec-
18 retary shall pubhsh such information in the elec-
19 tronic version of the Ust referred to at section
20 505(j)(7) ofthe Federal Food, Drug, and Cosmetic
21 Act (21 U.S.C. 355(j)(7)) as soon as it is received,
22 but in no event laterthan the date that is 90 days
23 aftertheenactmentofthisAct.
24 (3) With respect to anypatent information re-
25 ferredtoinparagraph (1) thatisfiledwiththe Sec-
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1 retarywithinthe 60-dayperiodafterthedateofen-
2 actment of this Act, each apphcant that, not later
3 than 120 days after the date of the enactment of
4 thisAct, amendsanapphcationthatis, onorbefore
5 thedateoftheenactmentofthisAct,asubstantially
6 complete apphcation (as defined in paragraph
7 (5)(B)(iv) of section 505(j) of the Federal Food,
8 Drug, andCosmeticAct (21 U.S.C. 355(j))) to con-
9 tain a certification described in paragraph
10 (2)(A)(vii)(IV) ofsuchsection 505(j)withrespectto
11 that patent shall be deemed to be a first applicant
12 (as defined in paragraph (5)(B)(iv) ofsuch section
13 505(j)).
14 SEC.5.CLARIFICATIONOFAUTHORITYFORUSEOFMED-
15 ICAIDINTEGRITYPROGRAMFUNDS.
16 (a) Clarification of Authority for Use of
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17 Funds.
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18 (1) In general. Section 1936 of the Social
19 SecurityAct(42U.S.C. 1396u-6)isamended—
20 (A) in subsection (b)(4),bystriking"Edu-
21 cationofandinserting"Educationortraining,
22 including at such national, State, or regional
23 conferences as the Secretary may estabhsh, of
24 State or local officers, employees, or inde-
25 pendentcontractorsresponsiblefortheadminis-
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1 trationorthe supervision ofthe administration
2 oftheStateplanunderthistitle,";and
3 (B) in subsection (e), by striking para-
4 graph(2) andinserting"thefollowing:
5 "(2) AVAILABILITY; AUTHORITY FOR USE OF
6 FUNDS.
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7 "(A) Availability. ^Amounts appro-
8 priatedpursuanttoparagraph (1) shaUremain
9 availableuntilexpended.
10 "(B)Authorityforuse of fundsfor
11 TRANSPORTATION AND TRAVEL EXPENSES FOR
12 ATTENDEESATEDUCATION,TRAINING,ORCON-
13 SULTATIVEACTIVITIES.
.
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14 "(i) In general. The Secretary
15 mayuseamountsappropriatedpursuantto
16 paragraph (1) to pay for transportation
17 andthetravelexpenses,includingperdiem
18 in Ueu of subsistence, at rates authorized
19 foremployeesofagenciesundersubchapter
20 I of chapter 57 of title 5, United States
21 Code,whileawayfromtheirhomes orreg-
22 ular places of business, of individuals de-
23 scribed in subsection (b)(4) who attend
24 education, training, or consultative activi-
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