FIRSTREGULARSESSION
HOUSECOMMITTEESUBSTITUTEFOR
HOUSEBILLNO.198
102NDGENERALASSEMBLY
0545H.02C DANARADEMANMILLER,ChiefClerk
ANACT
Toamendchapter376,RSMo,byaddingtheretofournewsectionsrelatingtoinsurance
coverageofpharmacyservices,withpenaltyprovisions.
BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows:
SectionA.Chapter376,RSMo,isamendedbyaddingtheretofournewsections,to
2beknownassections376.411,376.413,376.414,and376.415,toreadasfollows:
376.411.1.Forpurposesofthissection,thefollowingtermsmean:
2 (1)"Clinician-administereddrug",anylegenddrug,asdefinedinsection
3338.330,thatisadministeredbyahealthcareproviderwhoisauthorizedtoadminister
4thedrug;
5 (2)"Healthcarrier",thesamemeaninggiventotheterminsection376.1350;
6 (3)"Participatingprovider",thesamemeaninggiventotheterminsection
7376.1350;
8 (4)"Pharmacybenefitsmanager",thesamemeaninggiventotheterminsection
9376.388.
10 2.Ahealthcarrier,apharmacybenefitsmanager,oranagentoraffiliateofsuch
11healthcarrierorpharmacybenefitsmanagershallnot:
12 (1)Imposeanypenalty,impediment,differentiation,orlimitationona
13participatingproviderforprovidingmedicallynecessaryclinician-administereddrugs
14regardlessofwhethertheparticipatingproviderobtainssuchdrugsfromaprovider
15thatisinthenetworkincluding,butnotlimitedto,refusingtoapproveorpayor
16reimbursinglessthanthecontractedpaymentamount;
17 (2)Imposeanypenalty,impediment,differentiation,orlimitationonacovered
18personwhoisadministeredmedicallynecessaryclinician-administereddrugsregardless
EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis
intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 19ofwhethertheparticipatingproviderobtainssuchdrugsfromaproviderthatisinthe
20networkincluding,butnotlimitedto,limitingcoverageorbenefits;requiringan
21additionalfee,higherco-payment,orhighercoinsuranceamount;orinterferingwitha
22patient'sabilitytoobtainaclinician-administereddrugfromthepatient'sprovideror
23pharmacyofchoicebyanymeansincluding,butnotlimitedto,inducing,steering,or
24offeringfinancialorotherincentives;or
25 (3)Imposeanypenalty,impediment,differentiation,orlimitationonany
26pharmacy,includinganyclassBhospitalpharmacyasdefinedinsection338.220,thatis
27dispensingmedicallynecessaryclinician-administereddrugsregardlessofwhetherthe
28participatingproviderobtainssuchdrugsfromaproviderthatisinthenetwork
29including,butnotlimitedto,requiringapharmacytodispensesuchdrugstoapatient
30withtheintentionthatthepatientwilltransportthemedicationtoahealthcare
31providerforadministration.
32 3.Theprovisionsofthissectionshallnotapplyiftheclinician-administereddrug
33isnototherwisecoveredbythehealthcarrierorpharmacybenefitsmanager.
376.413.1.Forpurposesofthissection,theterm"healthcarrier"shallhavethe
2samemeaninggiventotheterminsection376.1350,andtheterm"pharmacybenefits
3manager"shallhavethesamemeaninggiventotheterminsection376.388.
4 2.Ahealthcarrier,apharmacybenefitsmanager,oranagentoraffiliateofsuch
5healthcarrierorpharmacybenefitsmanagershallnot:
6 (1)Discriminate,lowerthereimbursement,orimposeanyseparatetermsupon
7anentityinanycontractbased,inwholeorinpart,ontheentity'sparticipationinthe
8340Bdrugpricingprogramasdescribedin42U.S.C.Section256bincluding,butnot
9limitedto:
10 (a)Requiringanentityparticipatinginthe340Bdrugpricingprogramto
11reverse,resubmit,orclarifya340Bdrug-pricingclaimaftertheinitialadjudication
12unlesstheseactionsareinthenormalcourseofpharmacybusinessandnotrelatedto
13340Bdrugpricing;
14 (b)Requiringabillingmodifiertoindicatethatthedrugorclaimisa340Bdrug-
15pricingclaimorimposinganybillingorreportingrequirementsthatidentifywhethera
16drugwaspurchasedthroughthe340Bdrugpricingprogram;
17 (c)Excludinganentityfromanetworkonthebasis,inwholeorinpart,ofthe
18entity'sparticipationinthe340Bdrugpricingprogram;
19 (d)Establishingorsettingnetworkadequacyrequirementsbased,inwholeorin
20part,on340Bdrugpricingprogramparticipationbyaproviderorapharmacy;
21 (e)Prohibitinganentityauthorizedtoparticipatein340Bdrugpricingora
22pharmacyundercontractwithanentityauthorizedtoparticipatein340Bdrugpricing
HCSHB198 2 23fromparticipatingintheprovidernetworkonthebasis,inwholeorinpart,of
24participationin340Bdrugpricing;
25 (f)Offeringalowerreimbursementforadrugpurchasedunderthe340Bdrug
26pricingprogramthanforthesamedrugnotpurchasedunder340Bdrugpricing;
27 (g)Refusingtocoverdrugspurchasedunderthe340Bdrugpricingprogram;or
28 (h)Chargingmorethanfairmarketvalueorseekingprofitsharinginexchange
29forservicesinvolvingthe340Bdrugpricingprogram;or
30 (2)Limitapatient'sfreedomtouseanentitythatparticipatesinthe340Bdrug
31pricingprogrambyanymeansincluding,butnotlimitedto,modifyingapatient's
32paymentlimitationsorcost-sharingobligationsonthebasisofparticipation,inwholeor
33inpart,inthe340Bdrugpricingprogram.
34 3.Apharmacybenefitsmanagershallnotbasedrugformularyordrugcoverage
35decisionsuponthe340Bdrug-pricingstatusofadrug,includingpriceoravailability,or
36whetheradispensingentityparticipatesinthe340Bdrugpricingprogram.
37 4.Apharmaceuticalmanufacturershallnotprohibitanentityfromcontracting
38orparticipatingwithanentityauthorizedtoparticipateinthe340Bdrugpricing
39programbydenyingaccesstodrugsthataremanufacturedbythepharmaceutical
40manufacturerorbydenyingtheentitytheabilitytopurchasedrugsat340Bprogram
41pricingbysubstitutingarebatediscount.
42 5.Allpharmacyclaimsprocessedbyapharmacythatparticipatesinthe340B
43drugpricingprogramarefinalatthepointofadjudication.
376.414.1.Forpurposesofthissection,thefollowingtermsmean:
2 (1)"340Bdrug",adrugthatis:
3 (a)AcoveredoutpatientdrugasdefinedinSection340BofthePublicHealth
4ServiceAct,42U.S.C.Section256b,enactedbySection602oftheVeteransHealthCare
5Actof1992,Pub.L.102-585;and
6 (b)Purchasedunderanagreemententeredintounder42U.S.C.Section256b;
7 (2)"Coveredentity",thesamemeaninggiventotheterminSection340B(a)(4)
8ofthePublicHealthServiceAct,42U.S.C.Section256b(a)(4);
9 (3)"Healthcarrier",thesamemeaninggiventotheterminsection376.1350;
10 (4)"Pharmacy",anentitylicensedunderchapter338;
11 (5)"Pharmacybenefitsmanager",thesamemeaninggiventotheterminsection
12376.388.
13 2.Ahealthcarrier,apharmacybenefitsmanager,oranagentoraffiliateofsuch
14healthcarrierorpharmacybenefitsmanager,notincludingapharmaceutical
15manufacturer,shallnotdiscriminateagainstacoveredentityorapharmacy
16including,butnotlimitedto,bydoinganyofthefollowing:
HCSHB198 3 17 (1)Reimbursingacoveredentityorpharmacyforaquantityofa340Bdrugin
18anamountlessthanitwouldpaytoanyothersimilarlysituatedpharmacythatisnota
19coveredentityorapharmacyforsuchquantityofsuchdrugonthebasisthattheentity
20orpharmacyisacoveredentityorpharmacyorthattheentityorpharmacydispenses
21340Bdrugs;
22 (2)Imposinganytermsorconditionsoncoveredentitiesorpharmaciesthat
23differfromsuchtermsorconditionsappliedtoothersimilarlysituatedpharmaciesor
24entitiesthatarenotcoveredentitiesonthebasisthattheentityorpharmacyisacovered
25entityorthattheentityorpharmacydispenses340Bdrugsincluding,butnotlimitedto,
26termsorconditionswithrespecttoanyofthefollowing:
27 (a)Fees,chargebacks,clawbacks,adjustments,orotherassessments;
28 (b)Professionaldispensingfees;
29 (c)Restrictionsorrequirementsregardingparticipationinstandardor
30preferredpharmacynetworks;
31 (d)Requirementsrelatingtothefrequencyorscopeofauditsortoinventory
32managementsystemsusinggenerallyacceptedaccountingprinciples;and
33 (e)Anyotherrestrictions,conditions,practices,orpoliciesthat,asspecifiedby
34thedirectorofthedepartmentofcommerceandinsurance,interferewiththeabilityofa
35coveredentitytomaximizethevalueofdiscountsprovidedunder42U.S.C.Section
36256b;
37 (3)Interferingwithanindividual'schoicetoreceivea340Bdrugfromacovered
38entityorpharmacy,whetherinpersonorviadirectdelivery,mail,orotherformof
39shipment,byanymeansincluding,butnotlimitedto,modifyingapatient'spayment
40limitationsorcost-sharingobligationsonthebasisofparticipation,inwholeorinpart,
41inthe340Bdrugpricingprogram;
42 (4)Requiringacoveredentityorpharmacytoidentify,eitherdirectlyor
43throughathirdparty,340Bdrugs.However,apharmaceuticalmanufacturermayenter
44intoacontracttoutilizeanindustrystandardplatformtoidentifya340Bdispensation
45nosoonerthanforty-fivedaysafterthepointofsaleofthe340Bdrug.Ahealthcarrier,
46pharmacybenefitsmanager,oragentoraffiliateofsuchhealthcarrierorpharmacy
47benefitsmanagermayonlyusesuchidentificationinformationtocomplywithrebate
48transparencyrequirementsofapharmaceuticalmanufacturer;
49 (5)Refusingtocontractwithacoveredentityorpharmacyforreasonsother
50thanthosethatapplyequallytoentitiesthatarenotcoveredentitiesorsimilarly
51situatedpharmacies,oronthebasisthat:
52 (a)Theentityisacoveredentity;or
HCSHB198 4 53 (b)Theentityorpharmacyisdescribedinanyofsubparagraphs(A)to(O)of42
54U.S.C.Section256b(a)(4);
55 (6)Denyingthecoveredentitytheabilitytopurchasedrugsat340Bprogram
56pricingbysubstitutingarebatediscount;
57 (7)Refusingtocoverdrugspurchasedunderthe340Bdrugpricingprogram;or
58 (8)Requiringacoveredentityorpharmacytoreverse,resubmit,orclarifya
59340B-drugpricingclaimaftertheinitialadjudicationunlesstheseactionsareinthe
60normalcourseofpharmacybusinessandnotrelatedto340Bdrugpricing,exceptas
61requiredbyfederallaw.
62 3.Thedirectorofthedepartmentofcommerceandinsuranceshallimposea
63civilpenaltyonanyhealthcarrier,pharmacybenefitsmanager,oragentoraffiliateof
64suchhealthcarrierorpharmacybenefitsmanagerthatviolatestherequirementsofthis
65section.Suchpenaltyshallnotexceedfivethousanddollarsperviolationperday.
66 4.Thedirectorofthedepartmentofcommerceandinsuranceshallpromulgate
67rulestoimplementtheprovisionsofthissection.Anyruleorportionofarule,asthat
68termisdefinedinsection536.010,thatiscreatedundertheauthoritydelegatedinthis
69sectionshallbecomeeffectiveonlyifitcomplieswithandissubjecttoallofthe
70provisionsofchapter536and,ifapplicable,section536.028.Thissectionandchapter
71536arenonseverableandifanyofthepowersvestedwiththegeneralassembly
72pursuanttochapter536toreview,todelaytheeffectivedate,ortodisapproveandannul
73arulearesubsequentlyheldunconstitutional,thenthegrantofrulemakingauthority
74andanyruleproposedoradoptedafterAugust28,2023,shallbeinvalidandvoid.
376.415.1.Forpurposesofthissection,thefollowingtermsmean:
2 (1)"Biologicalproduct",thesamemeaninggiventothetermin42U.S.C.
3Section262(i);
4 (2)"Biosimilar",thesamemeaninggiventothetermin42U.S.C.Section262(i);
5 (3)"Healthcarrier",thesamemeaninggiventotheterminsection376.1350;
6 (4)"Pharmacybenefitsmanager",thesamemeaninggiventotheterminsection
7376.388;
8 (5)"Referenceproduct",thesamemeaninggiventothetermin42U.S.C.
9Section262(i).
10 2.Ahealthcarrier,apharmacybenefitsmanager,oranagentoraffiliateofsuch
11healthcarrierorpharmacybenefitsmanagerthatprovidescoverageforareference
12productorabiologicalproductthatisbiosimilartothereferenceproductshallprovide
13coverageforthereferenceproductandallbiologicalproductsthathavebeendeemed
14biosimilartothereferenceproduct.Thescope,extent,andamountofsuchrequired
HCSHB198 5 15coverageshallbethesameincluding,butnotlimitedto,anypaymentlimitationsorcost-
16sharingobligations.
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HCSHB198 6