FIRSTREGULARSESSION
[PERFECTED]
HOUSEBILLNO.1154
102NDGENERALASSEMBLY
INTRODUCEDBYREPRESENTATIVEHOUX.
2459H.01P DANARADEMANMILLER,ChiefClerk
ANACT
Torepealsection191.480,RSMo,andtoenactinlieuthereofthreenewsectionsrelatingto
alternativetherapies.
BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows:
SectionA.Section191.480,RSMo,isrepealedandthreenewsectionsenactedinlieu
2thereof,tobeknownassections191.479,191.480,and192.950,toreadasfollows:
191.479.1.Forthepurposeofthissection,a"bonafidephysician-patient
2relationship"meansarelationshipbetweenaphysicianandapatientinwhichthe
3physician:
4 (1)Hascompletedanassessmentofthepatient'smedicalhistoryandcurrent
5medicalcondition,includinganin-personexaminationofthepatient;
6 (2)Hasconsultedwiththepatientwithrespecttothepatient'smedical
7condition;and
8 (3)Isavailabletoprovidefollow-upcareandtreatementtothepatient.
9 2.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof
10lawtothecontrary,anypersonwhoacquires,uses,produces,possesses,transfers,or
11administerspsilocybinfortheperson'sowntherapeuticuseshallnotbeinviolationof
12stateorlocallawandshallnotbesubjecttoacivilfine,penalty,orsanctionsolongas
13thefollowingconditionsaremet:
14 (1)Thepersonistwenty-oneyearsofageorolder;
15 (2)Thepersonsuffersfromposttraumaticstressdisorder,majordepressive
16disorder,orasubstanceusedisorderorrequiresend-of-lifecare;
EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis
intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 17 (3)Theperson:
18 (a)Hasenrolledinaclinicaltrialtostudytheuseofpsilocybintotreat
19posttraumaticstressdisorder,majordepressivedisorder,orsubstanceusedisordersor
20forend-of-lifecare;or
21 (b)Soughttoenrollinaclinicaltrialdescribedinparagraph(a)ofthis
22subdivisionbutwasdeclinedduetolackofspaceorlackofexistingclinicaltrialsfor
23whichthepersonwaseligible;
24 (4)Thepersoninformsthedepartmentofhealthandseniorservicesthatthe
25personplanstoacquire,use,produce,possess,transfer,oradministerpsilocybinin
26accordancewiththissection;
27 (5)Thepersonprovidesthedepartmentofhealthandseniorserviceswith:
28 (a)Documentationfromaphysicianwithwhomthepatienthasabonafide
29physician-patientrelationshipthatthepersonsuffersfromposttraumaticstress
30disorder,majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-
31lifecare;
32 (b)Thenameofapersonwhowillbepresentwiththepersonwhentheyuse
33psilocybinwhoisoneofthefollowing;
34 a.Alicensedphysician;
35 b.Alicensedtherapist;or
36 c.Licensedbythefederalgovernmentorothergovernmententityinthe
37therapeuticuseofpsilocybin;
38 (c)Theaddressofthelocationwheretheuseofpsilocybinwilltakeplace;and
39 (d)Thetimeperiod,nottoexceedtwelvemonths,duringwhichthepersonwill
40usepsilocybin;
41 (6)Thepersonensuresthatalaboratorylicensedbythestatetotestcontrolled
42substancesteststhepsilocybinthepersonintendstoingest;and
43 (7)Thepersonlimitstheuseofpsilocybintonomorethanonehundredandfifty
44milligramsofpsilocybinanalyte(4-phosphoryloxy-N,N-dimethyltryptamine)during
45anytwelvemonthperiod.
46 3.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof
47lawtothecontrary:
48 (1)Anypersontwenty-oneyearsofageorolderwhoassistsanotherpersonin
49anyoftheactsallowedundersubsection2ofthissectionshallnotbeinviolationofstate
50orlocallawandshallnotbesubjecttoacivilfine,penalty,orsanction;and
51 (2)Anylaboratorylicensedbythestatetotestcontrolledsubstancesorcannabis
52thattestspsilocybinforapersonengagedinactsallowedundersubsection2ofthis
HB1154 2 53sectionshallnotbeinviolationofstateorlocallawandshallnotbesubjecttoacivil
54fine,penalty,orsanction.
55 4.Subjecttoappropriation,thedepartmentofhealthandseniorservicesshall
56providegrantstotalingtwomilliondollarsforresearchontheuseandefficacyof
57psilocybinforpersonsdescribedinsubsection2ofthissection.
58 5.Thedepartmentofhealthandseniorservicesshallprepareandsubmittothe
59governor,lieutenantgovernor,andthegeneralassemblyannualreportsonany
60informationcollectedbythedepartmentontheimplementationandoutcomesoftheuse
61ofpsilocybinasdescribedinsubsection2ofthissection.
62 6.Thedepartmentofhealthandseniorservicesshallmaintainthe
63confidentialityofanypersonallyidentifiableprotectedinformationcollectedfromany
64personswhoprovideinformationtothedepartmentundersubsection2ofthissection.
65 7.Notwithstandinganyotherprovisionoflawtothecontrary,thedepartmentof
66healthandseniorservices,anyhealthcareproviders,andanyotherpersoninvolvedin
67theactsdescribedinsubsection2ofthissectionshallnotbesubjecttocriminalorcivil
68liabilityorsanctionunderthelawsofthisstateforprovidingcaretoapersonengagedin
69actsallowedundersubsection2ofthissection,exceptincasesofgrossnegligenceor
70willfulmisconduct.Nohealthcareprovidershallbesubjecttodisciplineagainsthisor
71herprofessionallicenseforprovidingcaretoapersonengagedinactsallowedunder
72subsection2ofthissection.
73 8.Notwithstandinganyotherprovisionoflawtothecontrary,aphysicianshall
74notbesubjecttocriminalorcivilliabilityorsanctionunderthelawsofthisstatefor
75providingdocumentationthatapersonsuffersfromposttraumaticstressdisorder,
76majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-lifecare,and
77nostateagencyorregulatoryboardshallrevoke,failtorenew,ortakeanyotheraction
78againstaphysician'slicenseissuedunderchapter334basedsolelyonthephysician's
79provisionofdocumentationthatapersonsuffersfromposttraumaticstressdisorder,
80majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-lifecare.
81 9.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagency,
82includingemployeestherein,shalldisclosetothefederalgovernment,anyfederal
83governmentemployee,oranyunauthorizedthirdpartythestatewidelistorany
84individualinformationofpersonswhomeettherequirementsofthissection.
191.480.1.Forpurposesofthissection,thefollowingtermsshallmean:
2 (1)"Eligiblepatient",apersonwhomeetsallofthefollowing:
3 (a)Hasaterminal, lifethreatening,orseverelydebilitatingconditionorillness;
4 (b)HasconsideredallothertreatmentoptionscurrentlyapprovedbytheUnited
5StatesFoodandDrugAdministrationandallrelevantclinicaltrialsconductedinthisstate;
HB1154 3 6 (c)Hasreceivedaprescriptionorrecommendationfromtheperson'sphysicianforan
7investigationaldrug,biologicalproduct,ordevice;
8 (d)Hasgivenwritteninformedconsentwhichshallbeatleastascomprehensiveas
9theconsentusedinclinicaltrialsfortheuseoftheinvestigationaldrug,biologicalproduct,or
10deviceor,ifthepatientisaminororlacksthementalcapacitytoprovideinformedconsent,a
11parentorlegalguardianhasgivenwritteninformedconsentonthepatient'sbehalf;and
12 (e)Hasdocumentationfromtheperson'sphysicianthatthepersonhasmetthe
13requirementsofthissubdivision;
14 (2)"Investigationaldrug,biologicalproduct,ordevice",adrug,biologicalproduct,or
15device,anyofwhichareusedtotreatthepatient'sterminalillness,thathassuccessfully
16completedphaseoneofaclinicaltrialbuthasnotbeenapprovedforgeneralusebythe
17UnitedStatesFoodandDrugAdministrationandremainsunderinvestigationinaclinical
18trial[. ThetermshallnotincludeScheduleIcontrolledsubstances];
19 (3)"Life-threatening",diseasesorconditions:
20 (a)Wherethelikelihoodofdeathishighunlessthecourseofthediseaseis
21interrupted;and
22 (b)Withpotentiallyfataloutcomes,wheretheendpointofclinicaltrialanalysis
23issurvival;
24 (4)"Severelydebilitating",diseasesorconditionsthatcausemajorirreversible
25morbidity;
26 (5)"Terminalillness",adiseasethatwithoutlife-sustainingprocedureswillresultin
27deathinthenearfutureorastateofpermanentunconsciousnessfromwhichrecoveryis
28unlikely.
29 2.Amanufacturerofaninvestigationaldrug,biologicalproduct,ordevicemaymake
30availablethemanufacturer'sinvestigationaldrug,biologicalproduct,ordevicetoeligible
31patientsunderthissection.Thissectiondoesnotrequirethatamanufacturermakeavailable
32aninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient.Amanufacturer
33may:
34 (1)Provideaninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient
35withoutreceivingcompensation;or
36 (2)Requireaneligiblepatienttopaythecostsoforassociatedwiththemanufacture
37oftheinvestigationaldrug,biologicalproduct,ordevice.
38 3.Thissectiondoesnotrequireahealthcareinsurertoprovidecoverageforthecost
39ofanyinvestigationaldrug,biologicalproduct,ordevice.Ahealthcareinsurermayprovide
40coverageforaninvestigationaldrug,biologicalproduct,ordevice.
41 4.Thissectiondoesnotrequirethedepartmentofcorrectionstoprovidecoveragefor
42thecostofanyinvestigationaldrug,biologicalproduct,ordevice.
HB1154 4 43 5.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor
44regulatoryboardshallrevoke,failtorenew,ortakeanyotheractionagainstaphysician's
45licenseissuedunderchapter334basedsolelyonthephysician'srecommendationtoan
46eligiblepatientregardingprescriptionforortreatmentwithaninvestigationaldrug,biological
47product,ordevice.Actionagainstahealthcareprovider'sMedicarecertificationbasedsolely
48onthehealthcareprovider'srecommendationthatapatienthaveaccesstoaninvestigational
49drug,biologicalproduct,ordeviceisprohibited.
50 6.Ifaprovisionofthissectionoritsapplicationtoanypersonorcircumstanceisheld
51invalid,theinvaliditydoesnotaffectotherprovisionsorapplicationsofthissectionthatcan
52begiveneffectwithouttheinvalidprovisionorapplication,andtothisendtheprovisionsof
53thissectionareseverable.
54 7.Iftheclinicaltrialisclosedduetolackofefficacyortoxicity,thedrugshallnotbe
55offered.Ifnoticeisgivenonadrug,product,ordevicetakenbyapatientoutsideofaclinical
56trial,thepharmaceuticalcompanyorpatient'sphysicianshallnotifythepatientofthe
57informationfromthesafetycommitteeoftheclinicaltrial.
58 8.Exceptinthecaseofgrossnegligenceorwillfulmisconduct,anypersonwho
59manufactures,imports,distributes,prescribes,dispenses,oradministersaninvestigational
60drugordevicetoaneligiblepatientwithaterminalillnessinaccordancewiththissection
61shallnotbeliableinanyactionunderstatelawforanyloss,damage,orinjuryarisingoutof,
62relatingto,orresultingfrom:
63 (1)Thedesign,development,clinicaltestingandinvestigation,manufacturing,
64labeling,distribution,sale,purchase,donation,dispensing,prescription,administration,or
65useofthedrugordevice;or
66 (2)Thesafetyoreffectivenessofthedrugordevice.
192.950.1.Notwithstandingtheprovisionsofchapter195or579tothecontrary,
2thedepartmentofhealthandseniorservices,incollaborationwithahospitaloperated
3byaninstitutionofhighereducationinthisstateorcontractresearchorganizations
4conductingtrialsapprovedbytheUnitedStatesFoodandDrugAdministration,shall
5conductastudyontheefficacyofusingalternativemedicineandtherapies,including,
6theuseofpsilocybin,inthetreatmentofpatientswhosufferfromposttraumaticstress
7disorder,majordepressivedisorder,orsubstanceabusedisordersorwhorequireend-
8of-lifecare.
9 2.(1)Inconductingthisstudy,thedepartmentofhealthandseniorservices,in
10collaborationwiththehospitalsormedicalcenterdescribedinsubsection1ofthis
11sectionandsubjecttoappropriations,shall:
HB1154 5 12 (a)Performaclinicaltrialonthetherapeuticefficacyofusingpsilocybininthe
13treatmentofpatientswhosufferfromposttraumaticstressdisorder,majordepressive
14disorder,orsubstanceusedisordersorwhorequireend-of-lifecare;and
15 (b)Reviewcurrentliteratureregarding:
16 a.Thesafetyandefficacyofpsilocybininthetreatmentofpatientswhosuffer
17fromposttraumaticstressdisorder,majordepressivedisorder,orsubstanceuse
18disordersorwhorequireend-of-lifecare;and
19 b.Theaccessthatpatientshavetopsilocybinforsuchtreatment.
20 (2)Thedepartmentofhealthandseniorservicesshallprepareandsubmittothe
21governor,lieutenantgovernor,andthegeneralassemblythefollowing:
22 (a)Quarterlyreportsontheprogressofthestudy;and
23 (b)Awrittenreport,submittedoneyearfollowingthecommencementofthe
24study,whichshall:
25 a.Containtheresultsofthestudyandanyrecommendationsforlegislativeor
26regulatoryaction;and
27 b.Highlightthoseclinicalpracticesthatappeartobemostsuccessfulaswellas
28anysafetyorhealthconcerns.
29 3.Thedepartmentofhealthandseniorservicesshallmaintainthe
30confidentialityofanypersonallyidentifiableprotectedinformationcollectedduring
31theclinicaltrialunderthissection.
32 4.Notwithstandinganyotherprovisionoflawtothecontrary,thedepartmentof
33healthandseniorservices,anyhealthcareproviders,andanyotherpersoninvolvedin
34theclinicaltrialunderthissectionshallnotbesubjecttocriminalorcivilliabilityor
35sanctionunderthelawsofthisstateforparticipatinginthetrial,exceptincasesofgross
36negligenceorwillfulmisconduct.Nohealthcareprovidershallbesubjecttodiscipline
37againsthisorherprofessionallicenseforparticipationinthetrial.
38 5.Notwithstandinganyotherprovisionoflawtothecontrary,aphysicianshall
39notbesubjecttocriminalorcivilliabilityorsanctionunderthelawsofthisstatefor
40referringapatienttotheclinicaltrialunderthissection,andnostateagencyor
41regulatoryboardshallrevoke,failtorenew,ortakeanyotheractionagainsta
42physician'slicenseissuedunderchapter334basedsolelyonthephysician'sreferralofa
43patienttotheclinicaltrialunderthissection.
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HB1154 6