FIRSTREGULARSESSION HOUSEBILLNO.840 103RDGENERALASSEMBLY INTRODUCEDBYREPRESENTATIVECOOK. 2109H.01I JOSEPHENGLER,ChiefClerk ANACT Torepealsections338.015,376.387,and376.388,RSMo,andtoenactinlieuthereoffour newsectionsrelatingtopaymentsforprescriptiondrugs. BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows: SectionA.Sections338.015,376.387,and376.388,RSMo,arerepealedandfour 2newsectionsenactedinlieuthereof,tobeknownassections338.015,376.387,376.388,and 3376.448,toreadasfollows: 338.015.1.Theprovisionsofsections338.010to338.015shallnotbeconstruedto 2inhibitthepatient'sfreedomofchoicetoobtainprescriptionservicesfromanylicensed 3pharmacistorpharmacy. [However,nothinginsections338.010to338.315abrogatesthe 4patient'sabilitytowaivefreedomofchoiceunderanycontractwithregardtopaymentor 5coverageofprescriptionexpense.] 6 2.Allpharmacistsmayprovidepharmaceuticalconsultationandadvicetopersons 7concerningthesafeandtherapeuticuseoftheirprescriptiondrugs. 8 3.Allpatientsshallhavetherighttoreceiveawrittenprescriptionfromtheir 9prescribertotaketothefacilityoftheirchoiceortohaveanelectronicprescription 10transmittedtothefacilityoftheirchoice. 11 4.Nopharmacybenefitsmanager,asdefinedinsection376.388,shallprohibitor 12redirectbycontract,orotherwisepenalizeorrestrict,acoveredperson,asdefinedin 13section376.387,fromobtaininganyofthefollowingfromacontractedpharmacy,as 14definedinsection376.388: 15 (1)Prescriptionservices,includingallprescriptionscoveredbythecovered 16person'shealthbenefitplan; EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 17 (2)Consultation;or 18 (3)Advice. 376.387.1.Forpurposesofthissection,thefollowingtermsshallmean: 2 (1)"Coveredperson",[thesamemeaningassuchtermisdefinedinsection376.1257] 3apolicyholder,subscriber,enrollee,orotherindividualwhoseprescriptiondrug 4coverageisadministeredthroughapharmacybenefitsmanagerorahealthbenefitplan; 5 (2)"Healthbenefitplan",thesamemeaningassuchtermisdefinedinsection 6376.1350; 7 (3)"Healthcarrier"or"carrier",thesamemeaningassuchtermisdefinedinsection 8376.1350; 9 (4)"Pharmacy",thesamemeaningassuchtermisdefinedinchapter338; 10 (5)"Pharmacybenefitsmanager",thesamemeaningassuchtermisdefinedin 11section376.388; 12 (6)"Pharmacybenefitsmanagerrebateaggregator",anyentitythatnegotiates 13withapharmaceuticalmanufactureronbehalfofapharmacybenefitsmanagerfora 14rebate; 15 (7)"Pharmacyclaimsdata",informationregardingaprescriptiontransaction 16thatisadjudicatedbyapharmacybenefitsmanagerforacoveredpersonbetweenthe 17pharmacyandthepharmacybenefitsmanagerandbetweenthepharmacybenefits 18managerandthehealthbenefitplansponsor; 19 (8)"Rebate",anydiscount,negotiatedconcession,orotherpaymentprovided 20byapharmaceuticalmanufacturer,pharmacy,orhealthbenefitplantoanentitytosell, 21provide,pay,orreimburseapharmacyorotherentityinthestateforthedispensation, 22coverage,oradministrationofaprescriptiondrugonbehalfofitselforanotherentity. 23 2.Nopharmacybenefitsmanagershall[includeaprovisioninacontractenteredinto 24ormodifiedonorafterAugust28,2018,withapharmacyorpharmacistthatrequires] 25requireacoveredpersontomakeapaymentforaprescriptiondrugatthepointofsaleinan 26amountthatexceedsthelesserof: 27 (1)Thecopaymentamountasrequiredunderthehealthbenefitplan;[or] 28 (2)Theamountanindividualwouldpayforaprescriptionifthatindividualpaidwith 29cash;or 30 (3)Theamountequaltothedifferenceofthefinalreimbursementamountpaid 31tothecontractedpharmacy,asdefinedinsection376.388,bythepharmacybenefits 32managerfortheprescriptiondrugminusanyrebatepaid,andanyamountpaidorowed 33bythehealthbenefitplan,fortheprescriptiondrug. 34 3.Apharmacyorpharmacistshallhavetherightto: HB840 2 35 (1)Providetoacoveredpersoninformationregardingtheamountofthecovered 36person'scostshareforaprescriptiondrug,thecoveredperson'scostofanalternativedrug, 37andthecoveredperson'scostofthedrugwithoutadjudicatingtheclaimthroughthe 38pharmacybenefitsmanager.Neitherapharmacynorapharmacistshallbeproscribedbya 39pharmacybenefitsmanagerfromdiscussinganysuchinformationorfromsellingamore 40affordablealternativetothecoveredperson; and 41 (2)Providetoahealthbenefitplansponsoranyinformation,including 42pharmacyclaimsdata,relatedtothesponsor'shealthbenefitplanexcepttotheextent 43prohibitedbylaw. 44 4.(1)Apharmacybenefitsmanagershallnotdirectlyorindirectly,including 45indirectlythroughapharmacyservicesadministrativeorganization,reducetheamount 46oftheclaimatthetimeoftheclaim'sadjudicationoraftertheclaimisadjudicated. 47 (2)Apharmacybenefitsmanagershallnotdirectlyorindirectly,including 48indirectlythroughapharmacyservicesadministrativeorganization,chargeapharmacy 49afeerelatedtotheadjudicationofaclaim,includinganyfeerelatedto: 50 (a)Thereceiptandprocessingofapharmacyclaim; 51 (b)Thedevelopmentormanagementofaclaimprocessingoradjudication 52network;or 53 (c)Participationinaclaimprocessingorclaimadjudicationnetwork. 54 5.Nopharmacybenefitsmanagershall,directlyorindirectly,chargeorholda 55pharmacistorpharmacyresponsibleforanyfeeamountrelatedtoaclaimthatisnotknownat 56thetimeoftheclaim'sadjudication,unlesstheamountisaresultofimproperlypaidclaims 57[orchargesforadministeringahealthbenefitplan]. 58 [5.ThissectionshallnotapplywithrespecttoclaimsunderMedicarePartD,orany 59otherplanadministeredorregulatedsolelyunderfederallaw,andtotheextentthissection 60maybepreemptedundertheEmployeeRetirementIncomeSecurityActof1974forself- 61fundedemployer-sponsoredhealthbenefitplans.] 62 6.Apharmacybenefitsmanagershallnotifyinwritinganyhealthcarrierwithwhich 63itcontractsifthepharmacybenefitsmanagerhasaconflictofinterest,anycommonalityof 64ownership,oranyotherrelationship,financialorotherwise,betweenthepharmacybenefits 65managerandanyotherhealthcarrierwithwhichthepharmacybenefitsmanagercontracts. 66 7.Anypharmacybenefitsmanagerthatentersintoacontracttosell,provide, 67pay,orreimburseapharmacyinthestateforprescriptiondrugsonbehalfofitselfor 68anotherentityshalldefineandapplytheterm"generic",withrespecttoprescription 69drugs,tomeanany"authorizedgenericdrug",asdefinedin21CFR314.3,approved 70underSection505(c)oftheFederalFood,Drug,andCosmeticAct,asamended. HB840 3 71 8.Anentityshalldefineandapplytheterm"rebate"ashavingthesame 72meaninggiventotheterminthissectioniftheentityentersintoacontracttosell, 73provide,pay,negotiaterebatesfor,orreimburseapharmacy,pharmacybenefits 74manager,pharmacybenefitsmanageraffiliateasdefinedinsection376.388,or 75pharmacybenefitsmanagerrebateaggregatorforprescriptiondrugsonbehalfofitself 76oranotherentity. 77 9.Apharmacybenefitsmanagerthathascontractedwithanentitytoprovide 78pharmacybenefitsmanagementservicesforsuchanentityoranypersonwhonegotiates 79withapharmacybenefitsmanageronbehalfofapurchaserofhealthcarebenefitsshall 80oweafiduciarydutytothatentityorpurchaserofhealthcarebenefitsandshall 81dischargethatdutyinaccordancewithfederalandstatelaw. 82 10.Apharmacybenefitsmanagershallhaveadutytodisclosetoahealthbenefit 83plansponsor.Asusedinthissubsection,"dutytodisclose"shallmeannotifyingthe 84healthbenefitplansponsorofmaterialfactsandactionstakenbyapharmacybenefits 85managerrelatedtotheadministrationofthepharmacybenefitsonbehalfofthehealth 86benefitplansponsorthat: 87 (1)Mayincreasecoststothesponsororitscoveredpersonsascomparedtoa 88moreprudentactionthatcouldbetaken;or 89 (2)Presentaconflictofinterestbetweentheinterestsofthesponsorandits 90coveredpersonsandtheinterestsofthepharmacybenefitsmanager. 91 11.Anyentitythatentersintoacontracttosell,provide,pay,orreimbursea 92pharmacyinthestateforprescriptiondrugsonbehalfofitselforanotherentityshall 93notprohibitahealthbenefitplansponsorandaparticipatingpharmacyfromdiscussing 94anyhealthbenefitplaninformation,includingpharmacyclaimsdataorcosts. 95 12.Itshallbeunlawfulforanypharmacybenefitsmanageroranypersonacting 96onitsbehalftochargeahealthbenefitplanorpayeradifferentamountfora 97prescriptiondrug'singredientcostordispensingfeethantheamountthepharmacy 98benefitsmanagerreimbursesapharmacyfortheprescriptiondrug'singredientcostor 99dispensingfeeifthepharmacybenefitsmanagerretainsanyamountofanysuch 100difference. 101 13.Thedepartmentofcommerceandinsuranceshallenforcethissection. 376.388.1.Asusedinthissection,unlessthecontextrequiresotherwise,the 2followingtermsshallmean: 3 (1)"Contractedpharmacy"[or"pharmacy"], apharmacylocatedinMissouri 4participatinginthenetworkofapharmacybenefitsmanagerthroughadirectorindirect 5contract; HB840 4 6 (2)["Healthcarrier",anentitysubjecttotheinsurancelawsandregulationsofthis 7statethatcontractsorofferstocontracttoprovide,deliver,arrangefor,payfor,orreimburse 8anyofthecostsofhealthcareservices,includingasicknessandaccidentinsurancecompany, 9ahealthmaintenanceorganization,anonprofithospitalandhealthservicecorporation,orany 10otherentityprovidingaplanofhealthinsurance,healthbenefits,orhealthservices,except 11thatsuchplanshallnotincludeanycoveragepursuanttoaliabilityinsurancepolicy,workers' 12compensationinsurancepolicy,ormedicalpaymentsinsuranceissuedasasupplementtoa 13liabilitypolicy; 14 (3)] "Maximumallowablecost",theper-unitamountthatapharmacybenefits 15managerreimbursesapharmacistforaprescriptiondrug,excludingadispensingor 16professionalfee; 17 [(4)](3)"Maximumallowablecostlist"or"MAClist",alistingofdrugproductsthat 18meetthestandarddescribedinthissection; 19 [(5)](4)"Pharmacy",assuchtermisdefinedinchapter338; 20 [(6)](5)"Pharmacybenefitsmanager",anentitythatcontractswithpharmacieson 21behalfofhealthcarriers[oranyhealthplansponsoredbythestateorapoliticalsubdivisionof 22thestate]orhealthbenefitplanstoprovideprescriptiondrugandpharmacistservices; 23 (6)"Pharmacybenefitsmanageraffiliate",apharmacyorpharmacistthat 24directlyorindirectly,throughoneormoreintermediaries,ownsorcontrols,isownedor 25controlledby,orisundercommonownershiporcontrolwithapharmacybenefits 26manager. 27 2.Uponeachcontractexecutionorrenewalbetweenapharmacybenefitsmanager 28andapharmacyorbetweenapharmacybenefitsmanagerandapharmacy'scontracting 29representativeoragent,suchasapharmacyservicesadministrativeorganization,apharmacy 30benefitsmanagershall,withrespecttosuchcontractorrenewal: 31 (1)Includeinsuchcontractorrenewalthesourcesutilizedtodeterminemaximum 32allowablecostandupdatesuchpricinginformationatleasteverysevendays;and 33 (2)Maintainaproceduretoeliminateproductsfromthemaximumallowablecostlist 34ofdrugssubjecttosuchpricingormodifymaximumallowablecostpricingatleastevery 35sevendays,ifsuchdrugsdonotmeetthestandardsandrequirementsofthissection,inorder 36toremainconsistentwithpricingchangesinthemarketplace. 37 3.Apharmacybenefitsmanagershallreimbursepharmaciesfordrugssubjectto 38maximumallowablecostpricingthathasbeenupdatedtoreflectmarketpricingatleastevery 39sevendaysassetforthundersubdivision(1)ofsubsection2ofthissection. 40 4.Apharmacybenefitsmanagershallnotplaceadrugonamaximumallowablecost 41listunlessthereareatleasttwotherapeuticallyequivalentmultisourcegenericdrugs,orat HB840 5 42leastonegenericdrugavailablefromatleastonemanufacturer,generallyavailablefor 43purchasebynetworkpharmaciesfromnationalorregionalwholesalers. 44 5.(1)Allcontractsbetweenapharmacybenefitsmanagerandacontractedpharmacy 45orbetweenapharmacybenefitsmanagerandapharmacy'scontractingrepresentativeor 46agent,suchasapharmacyservicesadministrativeorganization,shallincludeaprocessto 47internallyappeal,investigate,andresolvedisputesregardingmaximumallowablecost 48pricing.Theprocessshallincludethefollowing: 49 [(1)](a)Therighttoappealshallbelimitedtofourteencalendardaysfollowingthe 50reimbursementoftheinitialclaim;and 51 [(2)](b)Arequirementthatthepharmacybenefitsmanagershallrespondtoan 52appealdescribedinthissubsectionnolaterthanfourteencalendardaysafterthedatethe 53appealwasreceivedbysuchpharmacybenefitsmanager. 54 (2)Ifareimbursementtoacontractedpharmacyisbelowthepharmacy'scostto 55purchasethedrug,thepharmacymaydeclinetodispensetheprescription.Apharmacy 56benefitsmanagershallnotprohibitapharmacyfromdecliningtodispenseadrugfor 57suchreasonorotherwiseretaliateagainstapharmacyfordoingso. 58 (3)Apharmacybenefitsmanagershallnot: 59 (a)Payorreimburseapharmacyorpharmacistinthestateanamountlessthan 60theamountthatthepharmacybenefitsmanagerreimbursesapharmacybenefits 61manageraffiliateforprovidingthesameproductsandpharmacistservices,which 62amountshallbecalculatedonaper-unitbasisusingthesamegenericproductidentifier 63orgenericcodenumber; 64 (b)Payorreimburseapharmacyorpharmacistinthestatefortheingredient 65drugproductcomponentofpharmacistserviceslessthanthenationalaveragedrug 66acquisitioncostor,ifthenationalaveragedrugacquisitioncostisunavailable,the 67wholesaleacquisitioncost; 68 (c)Makeorpermitanyreductionofpaymentforpharmacistservicesbya 69pharmacybenefitsmanagerorahealthcarepayerdirectlyorindirectlytoapharmacy 70underareconciliationprocesstoaneffectiverateofreimbursementincluding,butnot 71limitedto,genericeffectiverates,brandeffectiverates,directandindirectremuneration 72fees,oranyotherreductionoraggregatereductionofpayment;or 73 (d)Removefromanypharmacyitslegalrighttocivilrecourseincluding,butnot 74limitedto,requiringapharmacytousearbitrationtosettlegrievances. 75 6.Forappealsthataredenied,thepharmacybenefitsmanagershallprovidethe 76reasonforthedenialandidentifythenationaldrugcodeofadrugproductthatmaybe 77purchasedbycontractedpharmaciesatapriceatorbelowthemaximumallowablecostand, 78whenapplicable,maybesubstitutedlawfully. HB840 6 79 7.Iftheappealissuccessful,thepharmacybenefitsmanagershall: 80 (1)Adjustthemaximumallowablecostpricethatisthesubjectoftheappealeffective 81onthedayafterthedatetheappealisdecided; 82 (2)Applytheadjustedmaximumallowablecostpricetoallsimilarlysituated 83pharmaciesasdeterminedbythepharmacybenefitsmanager;and 84 (3)Allowthepharmacythatsucceededintheappealtoreverseandrebillthe 85pharmacybenefitsclaimgivingrisetotheappeal. 86 8.Appealsshallbeupheldif: 87 (1)Thepharmacybeingreimbursedforthedrugsubjecttothemaximumallowable 88costpricinginquestionwasnotreimbursedasrequiredundersubsection3ofthissection;or 89 (2)Thedrugsubjecttothemaximumallowablecostpricinginquestiondoesnotmeet 90therequirementssetforthundersubsection4ofthissection. 376.448.1.Asusedinthissection,thefollowingtermsmean: 2 (1)"Cost-sharing",anyco-payment,coinsurance,deductible,amountpaidby 3anenrolleeforhealthcareservicesinexcessofacoveragelimitation,orsimilarcharge 4requiredbyoronbehalfofanenrolleeinordertoreceiveaspecifichealthcareservice 5coveredbyahealthbenefitplan,whethercoveredundermedicalbenefitsorpharmacy 6benefits.Theterm"cost-sharing"shallincludecost-sharingasdefinedin42U.S.C. 7Section18022(c); 8 (2)"Enrollee",thesamemeaninggiventotheterminsection376.1350; 9 (3)"Healthbenefitplan",thesamemeaninggiventotheterminsection 10376.1350; 11 (4)"Healthcareservice",thesamemeaninggiventotheterminsection 12376.1350; 13 (5)"Healthcarrier",thesamemeaninggiventotheterminsection376.1350; 14 (6)"Pharmacybenefitsmanager",thesamemeaninggiventotheterminsection 15376.388. 16 2.Whencalculatinganenrollee'soverallcontributiontoanyout-of-pocket 17maximumoranycost-sharingrequirementunderahealthbenefitplan,ahealthcarrier 18orpharmacybenefitsmanagershallincludeanyamountspaidbytheenrolleeorpaid 19onbehalfoftheenrolleeforanymedicationwhereagenericsubstituteforsuch 20medicationisnotavailable. 21 3.Ahealthcarrierorpharmacybenefitsmanagershallnotvaryanenrollee's 22out-of-pocketmaximumoranycost-sharingrequirementbasedon,orotherwisedesign 23benefitsinamannerthattakesintoaccount,theavailabilityofanycost-sharing 24assistanceprogramforanymedicationwhereagenericsubstituteforsuchmedicationis 25notavailable. HB840 7 26 4.If,underfederallaw,applicationoftherequirementundersubsection2ofthis 27sectionwouldresultinhealthsavingsaccountineligibilityunderSection223ofthe 28InternalRevenueCodeof1986,asamended,therequirementundersubsection2ofthis 29sectionshallapplytohealthsavingsaccount-qualifiedhighdeductiblehealthplanswith 30respecttoanycost-sharingofsuchaplanaftertheenrolleehassatisfiedtheminimum 31deductibleunderSection223,exceptwithrespecttoitemsorservicesthatare 32preventivecareunderSection223(c)(2)(C)oftheInternalRevenueCodeof1986,as 33amended,inwhichcasetherequirementofsubsection2ofthissectionshallapply 34regardlessofwhethertheminimumdeductibleunderSection223hasbeensatisfied. 35 5.Nothinginthissectionshallprohibitahealthcarrierorhealthbenefitplan 36fromutilizingsteptherapyinaccordancewithsection376.2034. 37 6.Theprovisionsofthissectionshallnotapplytohealthbenefitplansthatare 38coveredundertheLaborManagementRelationsActof1947,29U.S.C.Section141et 39seq.,asamended. ✔ HB840 8