FIRSTREGULARSESSION
HOUSEBILLNO.1206
103RDGENERALASSEMBLY
INTRODUCEDBYREPRESENTATIVESTINNETT.
1791H.01I JOSEPHENGLER,ChiefClerk
ANACT
Toamendchapter191,RSMo,byaddingtheretosevennewsectionsrelatingtoaccessto
individualizedinvestigationaltreatment.
BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows:
SectionA.Chapter191,RSMo,isamendedbyaddingtheretosevennewsections,to
2beknownassections191.455,191.457,191.459,191.461,191.463,191.465,and191.467,to
3readasfollows:
191.455.1.Sections191.455to191.467shallbeknownandmaybecitedasthe
2"HopeforMissouriPatientsAct".
3 2.Asusedinsections191.455to191.467,unlessthecontextotherwiserequires,
4thefollowingtermsmean:
5 (1)"Eligiblefacility",aninstitutionthatisoperatingunderaFederalwide
6Assurance(FWA)fortheProtectionofHumanSubjectsunder42U.S.C.Section289(a)
7and45CFRPart46andthatissubjecttotheFWAlaws,regulations,policies,and
8guidelines,includingrenewalsorupdates;
9 (2)"Eligiblepatient",anindividualwhomeetsthefollowingconditions:
10 (a)HasconsideredallothertreatmentoptionscurrentlyapprovedbytheUnited
11StatesFoodandDrugAdministration;
12 (b)Hasreceivedarecommendationfromhisorherphysicianforan
13individualizedinvestigationaltreatmentbasedonanalysisofthepatient'sgenomic
14sequence;humanchromosomes;deoxyribonucleicacid;ribonucleicacid;genes;gene
15products,suchasenzymesandothertypesofproteins;ormetabolites;
EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis
intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 16 (c)Hasalife-threateningorseverelydebilitatingillness,oraseriousdiseaseor
17conditionassociatedwithmorbiditythathasasubstantialimpactonday-to-day
18functioning,asattestedtobythepatient'streatingphysician;
19 (d)Hasgivenwritten,informedconsentfortheuseoftheindividualized
20investigationaldrug,biologicalproduct,ordevice;and
21 (e)Hasdocumentationfromhisorherphysicianthatheorshemeetsthe
22requirementsofparagraphs(a)to(d)ofthissubdivision;
23 (3)"Individualizedinvestigationaldrug,biologicalproduct,ordevice",any
24drug,biologicalproduct,ordevicethatisuniquetoandproducedexclusivelyforusefor
25anindividualpatientbasedonthepatient'sowngeneticprofile.Theterm
26"individualizedinvestigationaldrug,biologicalproduct,ordevice":
27 (a)Shallinclude,butnotbelimitedto,individualizedgenetherapyantisense
28oligonucleotidesandindividualizedneoantigenvaccines;and
29 (b)Shallnotincludeanydrug,biologicalproduct,ordevicederivedfromhuman
30primaryorsecondaryembryonicstemcellsorcelllines,ortissuesorcellsderivedfrom
31abortion,butshallincludeanydrug,biologicalproduct,ordevicederivedfromhuman
32perinataltissues,cells,andsecretedfactorsnotobtainedfromanabortion;
33 (4)"Individualizedinvestigationaltreatment",treatmentwithanindividualized
34investigationaldrug,biologicalproduct,ordevice;
35 (5)"Life-threateningorseverelydebilitatingillness",anydiseaseorcondition
36thatislife-threateningorseverelydebilitating,assuchtermsaredefinedin21CFR
37312.81oranysuccessorlaworregulation,asapplicable;
38 (6)"Written,informedconsent",awrittendocumentthat:
39 (a)Issignedbythepatientor,ifthepatientisaminor,signedbyanyperson
40authorizedtoconsentundersection431.061;
41 (b)Isattestedtobythepatient'sphysicianandawitness;and
42 (c)Ataminimum,includesallofthefollowing:
43 a.Anexplanationofthecurrentlyapprovedproductsandtreatmentsforthe
44illness,disease,orconditionfromwhichthepatientsuffers;
45 b.Anattestationthatthepatientconcurswithhisorherphysicianinbelieving
46thatallcurrentlyapprovedandconventionallyrecognizedtreatmentsareunlikelyto
47prolongthepatient'slife;
48 c.Clearidentificationofthespecificproposedindividualizedinvestigational
49drug,biologicalproduct,ordevicethatthepatientisseekingtouse;
50 d.Adescriptionofthepotentiallybestandworstoutcomesofusingthe
51individualizedinvestigationaldrug,biologicalproduct,ordeviceandarealistic
52descriptionofthemostlikelyoutcome.Thedescriptionshallincludethepossibility
HB1206 2 53thatnew,unanticipated,different,orworsesymptomsmightresultandthatdeathcould
54behastenedbytheproposedtreatment.Thedescriptionshallbebasedonthe
55physician'sknowledgeoftheproposedtreatmentinconjunctionwithanawarenessof
56thepatient'scondition;
57 e.Astatementthatthepatient'shealthplanorthird-partyadministratorand
58providerarenotobligatedtopayforanycareortreatmentsconsequenttotheuseofthe
59individualizedinvestigationaldrug,biologicalproduct,ordeviceunlesstheyare
60specificallyrequiredtodosobylaworcontract;
61 f.Astatementthatthepatient'seligibilityforhospicecaremaybewithdrawnif
62thepatientbeginscurativetreatmentwiththeindividualizedinvestigationaldrug,
63biologicalproduct,ordeviceandthatcaremaybereinstatedifthistreatmentendsand
64thepatientmeetshospiceeligibilityrequirements;and
65 g.Astatementthatthepatientunderstandsthatheorsheisliableforall
66expensesconsequenttotheuseoftheindividualizedinvestigationaldrug,biological
67product,ordeviceandthatthisliabilityextendstothepatient'sestateunlessacontract
68betweenthepatientandthemanufactureroftheindividualizedinvestigationaldrug,
69biologicalproduct,ordevicestatesotherwise.
191.457.1.Amanufactureroperatingwithinaneligiblefacilityandin
2accordancewithallapplicableFederalwideAssurancelawsandregulationsmaymake
3availableanindividualizedinvestigationaldrug,biologicalproduct,ordeviceandan
4eligiblepatientmayrequestanindividualizedinvestigationaldrug,biologicalproduct,
5ordevicefromaneligiblefacilityormanufactureroperatingwithinaneligiblefacility
6undersections191.455to191.467.Sections191.455to191.467shallnotrequirethata
7manufacturermakeavailableanindividualizedinvestigationaldrug,biologicalproduct,
8ordevicetoaneligiblepatient.
9 2.Aneligiblefacilityormanufactureroperatingwithinaneligiblefacilitymay
10doallofthefollowing:
11 (1)Provideanindividualizedinvestigationaldrug,biologicalproduct,ordevice
12toaneligiblepatientwithoutreceivingcompensation;and
13 (2)Requireaneligiblepatienttopaythecostsof,orthecostsassociatedwith,the
14manufactureoftheindividualizedinvestigationaldrug,biologicalproduct,ordevice.
191.459.1.Sections191.455to191.467shallnotexpandthecoveragerequiredof
2aninsurerunderchapter376.
3 2.Ahealthplan,third-partyadministrator,orgovernmentalagencymay,butis
4notrequiredto,providecoverageforthecostofanindividualizedinvestigationaldrug,
5biologicalproduct,ordeviceorthecostofservicesrelatedtotheuseofanindividualized
HB1206 3 6investigationaldrug,biologicalproduct,ordeviceinaccordancewithsections191.455to
7191.467.
8 3.Sections191.455to191.467shallnotrequireanygovernmentalagencytopay
9costsassociatedwiththeuseoforcareortreatmentofapatientwithanindividualized
10investigationaldrug,biologicalproduct,ordevice.
11 4.Sections191.455to191.467shallnotrequireahospitalorfacilitylicensedby
12thedepartmentofhealthandseniorservicestoprovideneworadditionalservicesunless
13approvedbythehospitalorfacility.
191.461.Ifapatient'sdeathisproximatelycausedbytreatmentwithan
2individualizedinvestigationaldrug,biologicalproduct,ordevice,thepatient'sestate,
3heirs,ordeviseesshallnotbeliableforanydebtremainingafterpaymentbyinsurance
4forchargesdirectlyincurredforsuchtreatment.However,thissectionshallnotprovide
5anexemptiontoliabilityforchargesfornonexperimentaltreatmentsprovidedtothe
6patient,includingnonexperimentaltreatmentsrenderedtothepatientdueto
7complicationsorconsequencesoftheexperimentaltreatment.
191.463.1.Alicensingboardordisciplinarysubcommitteeshallnotrevoke,fail
2torenew,suspend,ortakeanyactionagainstahealthcareprovider'slicensebased
3solelyonthehealthcareprovider'srecommendationstoaneligiblepatientregarding
4accesstoortreatmentwithanindividualizedinvestigationaldrug,biologicalproduct,or
5device.
6 2.AnentityresponsibleforMedicarecertificationshallnottakeactionagainsta
7healthcareprovider'sMedicarecertificationbasedsolelyonthehealthcareprovider's
8recommendationthatapatienthaveaccesstoanindividualizedinvestigationaldrug,
9biologicalproduct,ordevice.
191.465.1.Anofficial,employee,oragentofthisstateshallnotblockorattempt
2toblockaneligiblepatient'saccesstoanindividualizedinvestigationaldrug,biological
3product,ordevice.
4 2.Counseling,advice,orarecommendationconsistentwithmedicalstandardsof
5carefromalicensedhealthcareprovidershallnotbeaviolationofthissection.
191.467.1.Sections191.455to191.467shallnotcreateaprivatecauseofaction
2againstamanufacturerofanindividualizedinvestigationaldrug,biologicalproduct,or
3deviceoragainstanyotherpersonorentityinvolvedinthecareofaneligiblepatient
4usingtheindividualizedinvestigationaldrug,biologicalproduct,ordeviceforanyharm
5donetotheeligiblepatientresultingfromtheindividualizedinvestigationaldrug,
6biologicalproduct,ordeviceifthemanufacturerorotherpersonorentityhascomplied
7ingoodfaithwiththetermsofsections191.455to191.467andhasexercisedreasonable
8care.
HB1206 4 9 2.Sections191.455to191.467shallnotaffectanyhealthcarecoveragerequired
10undersection376.429forcostsincurredduetoparticipationinclinicaltrials.
âś”
HB1206 5