FIRSTREGULARSESSION
HOUSEBILLNO.951
103RDGENERALASSEMBLY
INTRODUCEDBYREPRESENTATIVEOVERCAST.
1906H.01I JOSEPHENGLER,ChiefClerk
ANACT
Torepealsection191.480,RSMo,andtoenactinlieuthereoftwonewsectionsrelatingto
alternativetherapies.
BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows:
SectionA.Section191.480,RSMo,isrepealedandtwonewsectionsenactedinlieu
2thereof,tobeknownassections191.479and191.480,toreadasfollows:
191.479.1.Asusedinthissection,theterm"bonafideprescriber-patient
2relationship"meansarelationshipbetweenapatientandaphysicianorcertifiednurse
3practitionerasdefinedinsection335.016inwhichthephysicianorcertifiednurse
4practitioner:
5 (1)Hascompletedanassessmentofthepatient'smedicalhistoryandcurrent
6medicalcondition,includinganin-personexaminationofthepatient;
7 (2)Hasconsultedwiththepatientwithrespecttothepatient'smedical
8condition;and
9 (3)Isavailabletoprovidefollow-upcareandtreatmenttothepatient.
10 2.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof
11lawtothecontrary,anypersonwhoacquires,uses,produces,possesses,transfers,or
12administerspsilocybinfortheperson'sowntherapeuticuseshallnotbeinviolationof
13stateorlocallawandshallnotbesubjecttoacivilfine,penalty,orsanctionsolongas
14thefollowingconditionsaremet:
15 (1)Thepersonistwenty-oneyearsofageorolder;
16 (2)Thepersonrequiresend-of-lifecareorsuffersfromposttraumaticstress
17disorder,majordepressivedisorder,asubstanceusedisorder,oranyotherconditionfor
EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis
intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 18whichtreatmentwithpsilocybinhasshownefficacyinclinicaltrialsregisteredwiththe
19UnitedStatesFoodandDrugAdministration;
20 (3)Thepersonprovidesthedepartmentofmentalhealthwith:
21 (a)Documentationfromaphysicianorcertifiednursepractitionerwithwhom
22thepatienthasabonafideprescriber-patientrelationshipthatthepersonrequiresend-
23of-lifecareorsuffersfromadisorderorconditiondescribedinsubdivision(2)ofthis
24subsection;
25 (b)Thenameofthefacilitatorwhowillbepresentwiththepersonwhenthe
26personusespsilocybinandwhoisoneofthefollowing:
27 a.Aphysicianlicensedunderchapter334;
28 b.Apsychologistlicensedunderchapter337;
29 c.Amaster'slevelmentalhealththerapistwithfullclinicalexperiencesuchasa
30licensedclinicalsocialworker,maritalandfamilytherapist,orprofessionalcounselor,
31assuchprofessionsarelicensedunderchapter337;
32 d.Anurselicensedunderchapter335withadoctorofnursingpracticedegree;
33 e.Aphysicianassistantlicensedunderchapter334;or
34 f.Anadvancedpracticeregisterednurselicensedunderchapter335including,
35butnotlimitedto,apsychiatric-mentalhealthnursepractitioner;
36 (c)Theaddressofthelocationwheretheuseofpsilocybinwilltakeplace;and
37 (d)Thetimeperiod,nottoexceedtwelvemonths,duringwhichthepersonwill
38usepsilocybin;
39 (4)Thepersonensuresthatalaboratorylicensedbythestatetotestcontrolled
40substancesteststhepsilocybinthepersonintendstoingest;and
41 (5)Thepersonlimitstheuseofpsilocybintonomorethanonehundredfifty
42milligramsofpsilocybinanalyte(4-phosphoryloxy-N,N-dimethyltryptamine)orits
43naturalisticequivalentduringanytwelve-monthperiod.
44 3.(1)Inordertoserveasafacilitatordescribedundersubsection2ofthis
45section,anindividualshallhavecompletedatrainingprogramthatisspecificto
46psilocybinandthathasbeenapprovedforcontinuingeducationcreditbytheAmerican
47PsychologicalAssociation.Thecurriculumofthetrainingprogramrequiredunderthis
48subsectionshallconsistofatleastthirtyhoursofsynchronouslearning.Facilitators,
49excludingthosewhoarepsychologists,psychiatrists,orpsychiatric-mentalhealthnurse
50practitioners,shallcompleteninetyminutesofcontinuingeducationtrainingonthe
51mostcurrentversionoftheDiagnosticandStatisticalManualofMentalDisorders
52beforeservingasafacilitatorforanypersonandduringeachrelevantlicensurerenewal
53period.
HB951 2 54 (2)Anindividualshallhavetraininginend-of-lifecare,posttraumaticstress
55disorder,complexposttraumaticstressdisorder,majordepressivedisorder,substance
56usedisorder,orthespecificconditionforwhichpsilocybintherapyisindicatedinorder
57toserveasafacilitatorforapersonseekingpsilocybin-assistedpsychotherapytotreat
58suchconditions.
59 4.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof
60lawtothecontrary:
61 (1)Anypersontwenty-oneyearsofageorolderwhoassistsanotherpersonin
62anyoftheactsallowedundersubsection2ofthissectionshallnotbeinviolationofstate
63orlocallawandshallnotbesubjecttoacivilfine,penalty,orsanction;and
64 (2)Anylaboratorylicensedorregisteredbythestatetotestcontrolled
65substancesorcannabisthattestspsilocybinforapersonengagedinactsallowedunder
66subsection2ofthissectionshallnotbeinviolationofstateorlocallawandshallnotbe
67subjecttoacivilfine,penalty,orsanction.
68 5.Thedepartmentofmentalhealthshallmaintaintheconfidentialityofany
69personallyidentifiableprotectedinformationcollectedfromanypersonswhoprovide
70informationtothedepartmentunderthissection.
71 6.Notwithstandinganyotherprovisionoflawtothecontrary,thedepartmentof
72mentalhealth,anyhealthcareormentalhealthcareproviders,andanyotherperson
73involvedintheactsdescribedinsubsection2ofthissectionshallnotbesubjectto
74criminalorcivilliabilityorsanctionunderthelawsofthisstateforprovidingcaretoa
75personengagedinactsallowedundersubsection2ofthissection,exceptincasesof
76grossnegligenceorwillfulmisconduct.Nohealthcareprovidershallbesubjectto
77disciplineagainsthisorherprofessionallicenseforprovidingcaretoapersonengaged
78inactsallowedundersubsection2ofthissection.
79 7.Notwithstandinganyotherprovisionoflawtothecontrary,aphysicianor
80certifiednursepractitionershallnotbesubjecttocriminalorcivilliabilityorsanction
81underthelawsofthisstateforprovidingdocumentationthatapersonrequiresend-of-
82lifecareorsuffersfromadisorderorconditiondescribedinsubdivision(2)of
83subsection2ofthissection,andnostateagencyorregulatoryboardshallrevoke,failto
84renew,ortakeanyotheractionagainstalicenseissuedunderchapter334or335toa
85physicianorcertifiednursepractitionerbasedsolelyonthelicensee'sprovisionof
86documentationthatapersonrequiresend-of-lifecareorsuffersfromadisorderor
87conditiondescribedinsubdivision(2)ofsubsection2ofthissection.
88 8.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor
89employeeofastateagencyshalldisclosetothefederalgovernment,anyfederal
HB951 3 90governmentemployee,oranyunauthorizedthirdpartythestatewidelistorany
91individualinformationofpersonswhomeettherequirementsofthissection.
191.480.1.Forpurposesofthissection,thefollowingtermsshallmean:
2 (1)"Eligiblepatient",apersonwhomeetsallofthefollowing:
3 (a)Hasaterminalconditionorillness,alife-threateningconditionorillness,ora
4severelydebilitatingconditionorillness;
5 (b)HasconsideredallothertreatmentoptionscurrentlyapprovedbytheUnited
6StatesFoodandDrugAdministrationandallrelevantclinicaltrialsconductedinthisstate;
7 (c)Hasreceivedaprescriptionorrecommendationfromtheperson'sphysicianforan
8investigationaldrug,biologicalproduct,ordevice;
9 (d)Hasgivenwritteninformedconsentwhichshallbeatleastascomprehensiveas
10theconsentusedinclinicaltrialsfortheuseoftheinvestigationaldrug,biologicalproduct,or
11deviceor,ifthepatientisaminororlacksthementalcapacitytoprovideinformedconsent,a
12parentorlegalguardianhasgivenwritteninformedconsentonthepatient'sbehalf;and
13 (e)Hasdocumentationfromtheperson'sphysicianthatthepersonhasmetthe
14requirementsofthissubdivision;
15 (2)"Investigationaldrug,biologicalproduct,ordevice",adrug,biologicalproduct,or
16device,anyofwhichareusedtotreatthepatient'sterminalconditionorillness, life-
17threateningconditionorillness,orseverelydebilitatingconditionorillness, thathas
18successfullycompletedphaseoneofaclinicaltrialbuthasnotbeenapprovedforgeneraluse
19bytheUnitedStatesFoodandDrugAdministrationandremainsunderinvestigationina
20clinicaltrial[. ThetermshallnotincludeScheduleIcontrolledsubstances];
21 (3)"Life-threateningconditionorillness",adiseaseorcondition:
22 (a)Inwhichthelikelihoodofdeathishighunlessthecourseofthediseaseor
23conditionisinterrupted;and
24 (b)Withpotentiallyfataloutcomes,wheretheendpointofclinicaltrialanalysis
25issurvival;
26 (4)"Severelydebilitatingconditionorillness",adiseaseorconditionthatcauses
27majorirreversiblemorbidity;
28 (5)"Terminalconditionorillness",adiseaseorconditionthatwithoutlife-
29sustainingprocedureswillresultindeathinthenearfutureorastateofpermanent
30unconsciousnessfromwhichrecoveryisunlikely.
31 2.Amanufacturerofaninvestigationaldrug,biologicalproduct,ordevicemaymake
32availablethemanufacturer'sinvestigationaldrug,biologicalproduct,ordevicetoeligible
33patientsunderthissection.Thissectiondoesnotrequirethatamanufacturermakeavailable
34aninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient.Amanufacturer
35may:
HB951 4 36 (1)Provideaninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient
37withoutreceivingcompensation;or
38 (2)Requireaneligiblepatienttopaythecostsoforassociatedwiththemanufacture
39oftheinvestigationaldrug,biologicalproduct,ordevice.
40 3.Amanufacturerofanyinvestigationaldrug,biologicalproduct,ordeviceshall
41registerwiththedepartmentofhealthandseniorservices.BeforeNovember1,2025,
42thedepartmentofhealthandseniorservicesshallcreatearegistryofsuch
43manufacturersthatmanufactureanyinvestigationaldrug,biologicalproduct,or
44devicethatinvolvesacontrolledsubstance.
45 4.Thissectiondoesnotrequireahealthcareinsurertoprovidecoverageforthecost
46ofanyinvestigationaldrug,biologicalproduct,ordevice.Ahealthcareinsurermayprovide
47coverageforaninvestigationaldrug,biologicalproduct,ordevice.
48 [4.]5.Thissectiondoesnotrequirethedepartmentofcorrectionstoprovidecoverage
49forthecostofanyinvestigationaldrug,biologicalproduct,ordevice.
50 [5.]6.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor
51regulatoryboardshallrevoke,failtorenew,ortakeanyotheractionagainstaphysician's
52licenseissuedunderchapter334basedsolelyonthephysician'srecommendationtoan
53eligiblepatientregardingprescriptionforortreatmentwithaninvestigationaldrug,biological
54product,ordevice.Actionagainstahealthcareprovider'sMedicarecertificationbasedsolely
55onthehealthcareprovider'srecommendationthatapatienthaveaccesstoaninvestigational
56drug,biologicalproduct,ordeviceisprohibited.
57 [6.]7.Ifaprovisionofthissectionoritsapplicationtoanypersonorcircumstanceis
58heldinvalid,theinvaliditydoesnotaffectotherprovisionsorapplicationsofthissectionthat
59canbegiveneffectwithouttheinvalidprovisionorapplication,andtothisendtheprovisions
60ofthissectionareseverable.
61 [7.]8.Iftheclinicaltrialisclosedduetolackofefficacyortoxicity,thedrugshallnot
62beoffered.Ifnoticeisgivenonadrug,product,ordevicetakenbyapatientoutsideofa
63clinicaltrial,thepharmaceuticalcompanyorpatient'sphysicianshallnotifythepatientofthe
64informationfromthesafetycommitteeoftheclinicaltrial.
65 [8.]9.Exceptinthecaseofgrossnegligenceorwillfulmisconduct,anypersonwho
66manufactures,imports,distributes,prescribes,dispenses,oradministersaninvestigational
67drugordevicetoaneligiblepatient[withaterminalillness] inaccordancewiththissection
68shallnotbeliableinanyactionunderstatelawforanyloss,damage,orinjuryarisingoutof,
69relatingto,orresultingfrom:
70 (1)Thedesign,development,clinicaltestingandinvestigation,manufacturing,
71labeling,distribution,sale,purchase,donation,dispensing,prescription,administration,or
72useofthedrugordevice;or
HB951 5 73 (2)Thesafetyoreffectivenessofthedrugordevice.
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