SECONDREGULARSESSION
HOUSECOMMITTEESUBSTITUTEFOR
HOUSEBILLNO.1830
102NDGENERALASSEMBLY
4258H.03C DANARADEMANMILLER,ChiefClerk
ANACT
Torepealsection191.480,RSMo,andtoenactinlieuthereofthreenewsectionsrelatingto
alternativetherapies.
BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows:
SectionA.Section191.480,RSMo,isrepealedandthreenewsectionsenactedinlieu
2thereof,tobeknownassections191.479,191.480,and630.1170,toreadasfollows:
191.479.1.Asusedinthissection,thefollowingtermsmean:
2 (1)"Bonafidephysician-patientrelationship",arelationshipbetweena
3physicianandapatientinwhichthephysician:
4 (a)Hascompletedanassessmentofthepatient'smedicalhistoryandcurrent
5medicalcondition,includinganin-personexaminationofthepatient;
6 (b)Hasconsultedwiththepatientwithrespecttothepatient'smedical
7condition;and
8 (c)Isavailabletoprovidefollow-upcareandtreatmenttothepatient;
9 (2)"Facilitator",anindividualwhoispresentwithapersonwhousespsilocybin
10inordertofacilitatethetherapeuticuseofthepsilocybinfortheperson;
11 (3)"Veteran",anypersondefinedasaveteranbytheUnitedStatesDepartment
12ofVeteransAffairsoritssuccessoragency.
13 2.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof
14lawtothecontrary,anypersonwhoacquires,uses,produces,possesses,transfers,or
15administerspsilocybinfortheperson'sowntherapeuticuseshallnotbeinviolationof
16stateorlocallawandshallnotbesubjecttoacivilfine,penalty,orsanctionsolongas
17thefollowingconditionsaremet:
18 (1)Thepersonisaveteranwhoistwenty-oneyearsofageorolder;
EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis
intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 19 (2)Thepersonsuffersfromposttraumaticstressdisorder,majordepressive
20disorder,orasubstanceusedisorderorrequiresend-of-lifecare;
21 (3)Thepersonhasenrolledinastudyontheuseofpsilocybintotreat
22posttraumaticstressdisorder,majordepressivedisorder,orsubstanceusedisordersor
23forend-of-lifecare;
24 (4)Thepersoninformsthedepartmentofmentalhealththatthepersonplansto
25acquire,use,produce,possess,transfer,oradministerpsilocybininaccordancewiththis
26section;
27 (5)Thepersonprovidesthedepartmentofmentalhealthwith:
28 (a)Documentationfromaphysicianwithwhomthepatienthasabonafide
29physician-patientrelationshipthatthepersonsuffersfromposttraumaticstress
30disorder,majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-
31lifecare;
32 (b)Thenameoftheindividualwhowillserveastheperson'sfacilitator;
33 (c)Theaddressofthelocationwheretheuseofpsilocybinwilltakeplace;and
34 (d)Thetimeperiod,nottoexceedtwelvemonths,duringwhichthepersonwill
35usepsilocybin;
36 (6)Theperson'suseofpsilocybinoccursonlyinthepresenceofafacilitatorwho
37meetsthefollowingrequirements:
38 (a)Is:
39 a.Alicensedphysician;
40 b.Alicensedmentalhealthprofessionalwhoearnedadoctorofpsychology
41degreeoradoctorofphilosophydegreeinpsychology;
42 c.Amentalhealththerapistwhohasamaster'sdegreeinarelevantfieldand
43whohasfullclinicallicensureincluding,butnotlimitedto,alicensedclinicalsocial
44worker,alicensedmaritalandfamilytherapist,alicensedprofessionalcounselor,oran
45arttherapist;
46 d.Alicensednursewhoholdsadoctorateinnursingpractice;
47 e.Alicensedphysicianassistant;
48 f.Apsychiatricmentalhealthnursepractitioner;or
49 g.Alicensedadvancedpracticeregisterednurse;
50 (b)Hascompletedatrainingprogramthatisspecifictopsilocybinandthat:
51 a.Isconsistentwiththecurrentprofessionalpracticeguidelinesforpsychedelic-
52assistedtherapypublishedbytheAmericanPsychologicalAssociationortheAmerican
53PsychedelicPractitionersAssociationandcomplieswitheachsuchguideline;
HCSHB1830 2 54 b.Coversallcontentareassetforthintheprofessionalpracticeguidelinesofthe
55AmericanPsychologicalAssociationortheAmericanPsychedelicPractitioners
56Association;and
57 c.Consistsofatleastthirtyhoursofsynchronouslearning;
58 (c)Exceptforpsychiatrists,psychiatricmentalhealthnursepractitioners,and
59holdersofadoctoratedegreeinpsychology,completesninetyminutesofcontinuing
60educationontheDiagnosticandStatisticalManualofMentalDisordersbeforeserving
61asafacilitatorforanypersonandduringeachrelevantlicensurerenewalperiod;and
62 (d)Hasreceivedtraininginend-of-lifecareorinoneormoreofthefollowing
63diagnosticcategories:
64 a.Posttraumaticstressdisorder;
65 b.Complexposttraumaticstressdisorder;
66 c.Majordepressivedisorder;or
67 d.Substanceusedisorder;
68 (7)Thepersonensuresthatalaboratorylicensedbythestatetotestcontrolled
69substancesteststhepsilocybinthepersonintendstoingest;and
70 (8)Thepersonlimitstheuseofpsilocybintonomorethanonehundredfifty
71milligramsofpsilocybinanalyte(4-phosphoryloxy-N,N-dimethyltryptamine)during
72anytwelve-monthperiod.
73 3.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof
74lawtothecontrary:
75 (1)Anypersontwenty-oneyearsofageorolderwhoassistsanotherpersonin
76anyoftheactsallowedundersubsection2ofthissectionshallnotbeinviolationofstate
77orlocallawandshallnotbesubjecttoacivilfine,penalty,orsanction;and
78 (2)Anylaboratorylicensedbythestatetotestcontrolledsubstancesorcannabis
79thattestspsilocybinforapersonengagedinactsallowedundersubsection2ofthis
80sectionshallnotbeinviolationofstateorlocallawandshallnotbesubjecttoacivil
81fine,penalty,orsanction.
82 4.Subjecttoappropriation,thedepartmentofmentalhealthshallprovide
83grantstotalingtwomilliondollarsforresearchontheuseandefficacyofpsilocybinfor
84personsdescribedinsubsection2ofthissection.
85 5.Thedepartmentofmentalhealthshallprepareandsubmittothegovernor,
86lieutenantgovernor,andthegeneralassemblyannualreportsonanyinformation
87collectedbythedepartmentontheimplementationandoutcomesoftheuseof
88psilocybinasdescribedinsubsection2ofthissection.
HCSHB1830 3 89 6.Thedepartmentofmentalhealthshallmaintaintheconfidentialityofany
90personallyidentifiableprotectedinformationcollectedfromanypersonswhoprovide
91informationtothedepartmentundersubsection2ofthissection.
92 7.Notwithstandinganyotherprovisionoflawtothecontrary,thedepartmentof
93mentalhealth,anyhealthcareproviders,andanyotherpersoninvolvedintheacts
94describedinsubsection2ofthissectionshallnotbesubjecttocriminalorcivilliability
95orsanctionunderthelawsofthisstateforprovidingcaretoapersonengagedinacts
96allowedundersubsection2ofthissection,exceptincasesofgrossnegligenceorwillful
97misconduct.Nohealthcareprovidershallbesubjecttodisciplineagainsthisorher
98professionallicenseforprovidingcaretoapersonengagedinactsallowedunder
99subsection2ofthissection.
100 8.Notwithstandinganyotherprovisionoflawtothecontrary,aphysicianshall
101notbesubjecttocriminalorcivilliabilityorsanctionunderthelawsofthisstatefor
102providingdocumentationthatapersonsuffersfromposttraumaticstressdisorder,
103majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-lifecare,and
104nostateagencyorregulatoryboardshallrevoke,failtorenew,ortakeanyotheraction
105againstaphysician'slicenseissuedunderchapter334basedsolelyonthephysician's
106provisionofdocumentationthatapersonsuffersfromposttraumaticstressdisorder,
107majordepressivedisorder,orasubstanceusedisorderorrequiresend-of-lifecare.
108 9.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor
109employeeofastateagencyshalldisclosetothefederalgovernment,anyfederal
110governmentemployee,oranyunauthorizedthirdpartythestatewidelistorany
111individualinformationofpersonswhomeettherequirementsofthissection.
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;
HCSHB1830 4 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)Inwhichthelikelihoodofdeathishighunlessthecourseofthediseaseis
23interrupted;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:
36 (1)Provideaninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient
37withoutreceivingcompensation;or
38 (2)Requireaneligiblepatienttopaythecostsoforassociatedwiththemanufacture
39oftheinvestigationaldrug,biologicalproduct,ordevice.
40 3.Thissectiondoesnotrequireahealthcareinsurertoprovidecoverageforthecost
41ofanyinvestigationaldrug,biologicalproduct,ordevice.Ahealthcareinsurermayprovide
42coverageforaninvestigationaldrug,biologicalproduct,ordevice.
43 4.Thissectiondoesnotrequirethedepartmentofcorrectionstoprovidecoveragefor
44thecostofanyinvestigationaldrug,biologicalproduct,ordevice.
45 5.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor
46regulatoryboardshallrevoke,failtorenew,ortakeanyotheractionagainstaphysician's
47licenseissuedunderchapter334basedsolelyonthephysician'srecommendationtoan
48eligiblepatientregardingprescriptionforortreatmentwithaninvestigationaldrug,biological
49product,ordevice.Actionagainstahealthcareprovider'sMedicarecertificationbasedsolely
50onthehealthcareprovider'srecommendationthatapatienthaveaccesstoaninvestigational
51drug,biologicalproduct,ordeviceisprohibited.
HCSHB1830 5 52 6.Ifaprovisionofthissectionoritsapplicationtoanypersonorcircumstanceisheld
53invalid,theinvaliditydoesnotaffectotherprovisionsorapplicationsofthissectionthatcan
54begiveneffectwithouttheinvalidprovisionorapplication,andtothisendtheprovisionsof
55thissectionareseverable.
56 7.Iftheclinicaltrialisclosedduetolackofefficacyortoxicity,thedrugshallnotbe
57offered.Ifnoticeisgivenonadrug,product,ordevicetakenbyapatientoutsideofaclinical
58trial,thepharmaceuticalcompanyorpatient'sphysicianshallnotifythepatientofthe
59informationfromthesafetycommitteeoftheclinicaltrial.
60 8.Exceptinthecaseofgrossnegligenceorwillfulmisconduct,anypersonwho
61manufactures,imports,distributes,prescribes,dispenses,oradministersaninvestigational
62drugordevicetoaneligiblepatient[withaterminalillness] inaccordancewiththissection
63shallnotbeliableinanyactionunderstatelawforanyloss,damage,orinjuryarisingoutof,
64relatingto,orresultingfrom:
65 (1)Thedesign,development,clinicaltestingandinvestigation,manufacturing,
66labeling,distribution,sale,purchase,donation,dispensing,prescription,administration,or
67useofthedrugordevice;or
68 (2)Thesafetyoreffectivenessofthedrugordevice.
630.1170.1.Notwithstandingtheprovisionsofchapter195or579tothe
2contrary,thedepartmentofmentalhealth,incollaborationwithahospitaloperatedby
3aninstitutionofhighereducationinthisstateorwithcontractresearchorganizations
4conductingstudiesapprovedbytheUnitedStatesFoodandDrugAdministration,shall
5conductastudyontheefficacyofusingalternativemedicineandtherapies,including
6theuseofpsilocybin,inthetreatmentofveteranswhosufferfromposttraumaticstress
7disorder,majordepressivedisorder,orsubstanceusedisordersorwhorequireend-of-
8lifecare.
9 2.(1)Inconductingthestudy,thedepartmentofmentalhealth,incollaboration
10withthehospitalorcontractresearchorganizationsdescribedinsubsection1ofthis
11sectionandsubjecttoappropriations,shall:
12 (a)Performastudyonthetherapeuticefficacyofusingpsilocybininthe
13treatmentofveteranswhosufferfromposttraumaticstressdisorder,majordepressive
14disorder,orsubstanceusedisordersorwhorequireend-of-lifecare;and
15 (b)Reviewcurrentliteratureregarding:
16 a.Thesafetyandefficacyofpsilocybininthetreatmentofveteranswhosuffer
17fromposttraumaticstressdisorder,majordepressivedisorder,orsubstanceuse
18disordersorwhorequireend-of-lifecare;and
19 b.Theaccessthatveteranshavetopsilocybinforsuchtreatment.
HCSHB1830 6 20 (2)Thedepartmentofmentalhealthshallprepareandsubmittothegovernor,
21lieutenantgovernor,andthegeneralassemblythefollowing:
22 (a)Quarterlyreportsontheprogressofthestudy;and
23 (b)Awrittenreport,submittedoneyearfollowingthecommencementofthe
24study,thatshall:
25 a.Containtheresultsofthestudyandanyrecommendationsforlegislativeor
26regulatoryaction;and
27 b.Highlightthoseclinicalpracticesthatappeartobemostsuccessfulaswellas
28anysafetyorhealthconcerns.
29 3.Thedepartmentofmentalhealthshallmaintaintheconfidentialityofany
30personallyidentifiableprotectedinformationcollectedduringthestudyunderthis
31section.
32 4.Notwithstandinganyotherprovisionoflawtothecontrary,thedepartmentof
33mentalhealth,anyhealthcareproviders,andanyotherpersoninvolvedinthestudy
34underthissectionshallnotbesubjecttocriminalorcivilliabilityorsanctionunderthe
35lawsofthisstateforparticipatinginthestudy,exceptincasesofgrossnegligenceor
36willfulmisconduct.Nohealthcareprovidershallbesubjecttodisciplineagainsthisor
37herprofessionallicenseforparticipationinthestudy.
38 5.Notwithstandinganyotherprovisionoflawtothecontrary,aphysicianshall
39notbesubjecttocriminalorcivilliabilityorsanctionunderthelawsofthisstatefor
40referringaveterantothestudyunderthissection,andnostateagencyorregulatory
41boardshallrevoke,failtorenew,ortakeanyotheractionagainstaphysician'slicense
42issuedunderchapter334basedsolelyonthephysician'sreferralofaveterantothe
43studyunderthissection.
âś”
HCSHB1830 7