| 1 | 1 | | FIRSTREGULARSESSION |
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| 2 | 2 | | HOUSEBILLNO.951 |
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| 3 | 3 | | 103RDGENERALASSEMBLY |
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| 4 | 4 | | INTRODUCEDBYREPRESENTATIVEOVERCAST. |
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| 5 | 5 | | 1906H.01I JOSEPHENGLER,ChiefClerk |
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| 6 | 6 | | ANACT |
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| 7 | 7 | | Torepealsection191.480,RSMo,andtoenactinlieuthereoftwonewsectionsrelatingto |
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| 8 | 8 | | alternativetherapies. |
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| 9 | 9 | | BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows: |
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| 10 | 10 | | SectionA.Section191.480,RSMo,isrepealedandtwonewsectionsenactedinlieu |
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| 11 | 11 | | 2thereof,tobeknownassections191.479and191.480,toreadasfollows: |
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| 12 | 12 | | 191.479.1.Asusedinthissection,theterm"bonafideprescriber-patient |
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| 13 | 13 | | 2relationship"meansarelationshipbetweenapatientandaphysicianorcertifiednurse |
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| 14 | 14 | | 3practitionerasdefinedinsection335.016inwhichthephysicianorcertifiednurse |
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| 15 | 15 | | 4practitioner: |
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| 16 | 16 | | 5 (1)Hascompletedanassessmentofthepatient'smedicalhistoryandcurrent |
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| 17 | 17 | | 6medicalcondition,includinganin-personexaminationofthepatient; |
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| 18 | 18 | | 7 (2)Hasconsultedwiththepatientwithrespecttothepatient'smedical |
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| 19 | 19 | | 8condition;and |
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| 20 | 20 | | 9 (3)Isavailabletoprovidefollow-upcareandtreatmenttothepatient. |
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| 21 | 21 | | 10 2.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof |
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| 22 | 22 | | 11lawtothecontrary,anypersonwhoacquires,uses,produces,possesses,transfers,or |
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| 23 | 23 | | 12administerspsilocybinfortheperson'sowntherapeuticuseshallnotbeinviolationof |
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| 24 | 24 | | 13stateorlocallawandshallnotbesubjecttoacivilfine,penalty,orsanctionsolongas |
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| 25 | 25 | | 14thefollowingconditionsaremet: |
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| 26 | 26 | | 15 (1)Thepersonistwenty-oneyearsofageorolder; |
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| 27 | 27 | | 16 (2)Thepersonrequiresend-of-lifecareorsuffersfromposttraumaticstress |
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| 28 | 28 | | 17disorder,majordepressivedisorder,asubstanceusedisorder,oranyotherconditionfor |
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| 29 | 29 | | EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis |
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| 30 | 30 | | intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 18whichtreatmentwithpsilocybinhasshownefficacyinclinicaltrialsregisteredwiththe |
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| 31 | 31 | | 19UnitedStatesFoodandDrugAdministration; |
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| 32 | 32 | | 20 (3)Thepersonprovidesthedepartmentofmentalhealthwith: |
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| 33 | 33 | | 21 (a)Documentationfromaphysicianorcertifiednursepractitionerwithwhom |
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| 34 | 34 | | 22thepatienthasabonafideprescriber-patientrelationshipthatthepersonrequiresend- |
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| 35 | 35 | | 23of-lifecareorsuffersfromadisorderorconditiondescribedinsubdivision(2)ofthis |
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| 36 | 36 | | 24subsection; |
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| 37 | 37 | | 25 (b)Thenameofthefacilitatorwhowillbepresentwiththepersonwhenthe |
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| 38 | 38 | | 26personusespsilocybinandwhoisoneofthefollowing: |
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| 39 | 39 | | 27 a.Aphysicianlicensedunderchapter334; |
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| 40 | 40 | | 28 b.Apsychologistlicensedunderchapter337; |
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| 41 | 41 | | 29 c.Amaster'slevelmentalhealththerapistwithfullclinicalexperiencesuchasa |
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| 42 | 42 | | 30licensedclinicalsocialworker,maritalandfamilytherapist,orprofessionalcounselor, |
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| 43 | 43 | | 31assuchprofessionsarelicensedunderchapter337; |
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| 44 | 44 | | 32 d.Anurselicensedunderchapter335withadoctorofnursingpracticedegree; |
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| 45 | 45 | | 33 e.Aphysicianassistantlicensedunderchapter334;or |
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| 46 | 46 | | 34 f.Anadvancedpracticeregisterednurselicensedunderchapter335including, |
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| 47 | 47 | | 35butnotlimitedto,apsychiatric-mentalhealthnursepractitioner; |
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| 48 | 48 | | 36 (c)Theaddressofthelocationwheretheuseofpsilocybinwilltakeplace;and |
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| 49 | 49 | | 37 (d)Thetimeperiod,nottoexceedtwelvemonths,duringwhichthepersonwill |
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| 50 | 50 | | 38usepsilocybin; |
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| 51 | 51 | | 39 (4)Thepersonensuresthatalaboratorylicensedbythestatetotestcontrolled |
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| 52 | 52 | | 40substancesteststhepsilocybinthepersonintendstoingest;and |
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| 53 | 53 | | 41 (5)Thepersonlimitstheuseofpsilocybintonomorethanonehundredfifty |
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| 54 | 54 | | 42milligramsofpsilocybinanalyte(4-phosphoryloxy-N,N-dimethyltryptamine)orits |
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| 55 | 55 | | 43naturalisticequivalentduringanytwelve-monthperiod. |
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| 56 | 56 | | 44 3.(1)Inordertoserveasafacilitatordescribedundersubsection2ofthis |
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| 57 | 57 | | 45section,anindividualshallhavecompletedatrainingprogramthatisspecificto |
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| 58 | 58 | | 46psilocybinandthathasbeenapprovedforcontinuingeducationcreditbytheAmerican |
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| 59 | 59 | | 47PsychologicalAssociation.Thecurriculumofthetrainingprogramrequiredunderthis |
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| 60 | 60 | | 48subsectionshallconsistofatleastthirtyhoursofsynchronouslearning.Facilitators, |
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| 61 | 61 | | 49excludingthosewhoarepsychologists,psychiatrists,orpsychiatric-mentalhealthnurse |
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| 62 | 62 | | 50practitioners,shallcompleteninetyminutesofcontinuingeducationtrainingonthe |
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| 63 | 63 | | 51mostcurrentversionoftheDiagnosticandStatisticalManualofMentalDisorders |
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| 64 | 64 | | 52beforeservingasafacilitatorforanypersonandduringeachrelevantlicensurerenewal |
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| 65 | 65 | | 53period. |
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| 66 | 66 | | HB951 2 54 (2)Anindividualshallhavetraininginend-of-lifecare,posttraumaticstress |
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| 67 | 67 | | 55disorder,complexposttraumaticstressdisorder,majordepressivedisorder,substance |
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| 68 | 68 | | 56usedisorder,orthespecificconditionforwhichpsilocybintherapyisindicatedinorder |
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| 69 | 69 | | 57toserveasafacilitatorforapersonseekingpsilocybin-assistedpsychotherapytotreat |
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| 70 | 70 | | 58suchconditions. |
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| 71 | 71 | | 59 4.Notwithstandingtheprovisionsofchapter195or579oranyotherprovisionof |
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| 72 | 72 | | 60lawtothecontrary: |
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| 73 | 73 | | 61 (1)Anypersontwenty-oneyearsofageorolderwhoassistsanotherpersonin |
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| 74 | 74 | | 62anyoftheactsallowedundersubsection2ofthissectionshallnotbeinviolationofstate |
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| 75 | 75 | | 63orlocallawandshallnotbesubjecttoacivilfine,penalty,orsanction;and |
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| 76 | 76 | | 64 (2)Anylaboratorylicensedorregisteredbythestatetotestcontrolled |
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| 77 | 77 | | 65substancesorcannabisthattestspsilocybinforapersonengagedinactsallowedunder |
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| 78 | 78 | | 66subsection2ofthissectionshallnotbeinviolationofstateorlocallawandshallnotbe |
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| 79 | 79 | | 67subjecttoacivilfine,penalty,orsanction. |
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| 80 | 80 | | 68 5.Thedepartmentofmentalhealthshallmaintaintheconfidentialityofany |
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| 81 | 81 | | 69personallyidentifiableprotectedinformationcollectedfromanypersonswhoprovide |
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| 82 | 82 | | 70informationtothedepartmentunderthissection. |
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| 83 | 83 | | 71 6.Notwithstandinganyotherprovisionoflawtothecontrary,thedepartmentof |
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| 84 | 84 | | 72mentalhealth,anyhealthcareormentalhealthcareproviders,andanyotherperson |
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| 85 | 85 | | 73involvedintheactsdescribedinsubsection2ofthissectionshallnotbesubjectto |
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| 86 | 86 | | 74criminalorcivilliabilityorsanctionunderthelawsofthisstateforprovidingcaretoa |
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| 87 | 87 | | 75personengagedinactsallowedundersubsection2ofthissection,exceptincasesof |
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| 88 | 88 | | 76grossnegligenceorwillfulmisconduct.Nohealthcareprovidershallbesubjectto |
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| 89 | 89 | | 77disciplineagainsthisorherprofessionallicenseforprovidingcaretoapersonengaged |
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| 90 | 90 | | 78inactsallowedundersubsection2ofthissection. |
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| 91 | 91 | | 79 7.Notwithstandinganyotherprovisionoflawtothecontrary,aphysicianor |
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| 92 | 92 | | 80certifiednursepractitionershallnotbesubjecttocriminalorcivilliabilityorsanction |
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| 93 | 93 | | 81underthelawsofthisstateforprovidingdocumentationthatapersonrequiresend-of- |
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| 94 | 94 | | 82lifecareorsuffersfromadisorderorconditiondescribedinsubdivision(2)of |
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| 95 | 95 | | 83subsection2ofthissection,andnostateagencyorregulatoryboardshallrevoke,failto |
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| 96 | 96 | | 84renew,ortakeanyotheractionagainstalicenseissuedunderchapter334or335toa |
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| 97 | 97 | | 85physicianorcertifiednursepractitionerbasedsolelyonthelicensee'sprovisionof |
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| 98 | 98 | | 86documentationthatapersonrequiresend-of-lifecareorsuffersfromadisorderor |
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| 99 | 99 | | 87conditiondescribedinsubdivision(2)ofsubsection2ofthissection. |
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| 100 | 100 | | 88 8.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor |
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| 101 | 101 | | 89employeeofastateagencyshalldisclosetothefederalgovernment,anyfederal |
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| 102 | 102 | | HB951 3 90governmentemployee,oranyunauthorizedthirdpartythestatewidelistorany |
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| 103 | 103 | | 91individualinformationofpersonswhomeettherequirementsofthissection. |
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| 104 | 104 | | 191.480.1.Forpurposesofthissection,thefollowingtermsshallmean: |
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| 105 | 105 | | 2 (1)"Eligiblepatient",apersonwhomeetsallofthefollowing: |
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| 106 | 106 | | 3 (a)Hasaterminalconditionorillness,alife-threateningconditionorillness,ora |
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| 107 | 107 | | 4severelydebilitatingconditionorillness; |
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| 108 | 108 | | 5 (b)HasconsideredallothertreatmentoptionscurrentlyapprovedbytheUnited |
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| 109 | 109 | | 6StatesFoodandDrugAdministrationandallrelevantclinicaltrialsconductedinthisstate; |
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| 110 | 110 | | 7 (c)Hasreceivedaprescriptionorrecommendationfromtheperson'sphysicianforan |
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| 111 | 111 | | 8investigationaldrug,biologicalproduct,ordevice; |
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| 112 | 112 | | 9 (d)Hasgivenwritteninformedconsentwhichshallbeatleastascomprehensiveas |
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| 113 | 113 | | 10theconsentusedinclinicaltrialsfortheuseoftheinvestigationaldrug,biologicalproduct,or |
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| 114 | 114 | | 11deviceor,ifthepatientisaminororlacksthementalcapacitytoprovideinformedconsent,a |
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| 115 | 115 | | 12parentorlegalguardianhasgivenwritteninformedconsentonthepatient'sbehalf;and |
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| 116 | 116 | | 13 (e)Hasdocumentationfromtheperson'sphysicianthatthepersonhasmetthe |
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| 117 | 117 | | 14requirementsofthissubdivision; |
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| 118 | 118 | | 15 (2)"Investigationaldrug,biologicalproduct,ordevice",adrug,biologicalproduct,or |
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| 119 | 119 | | 16device,anyofwhichareusedtotreatthepatient'sterminalconditionorillness, life- |
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| 120 | 120 | | 17threateningconditionorillness,orseverelydebilitatingconditionorillness, thathas |
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| 121 | 121 | | 18successfullycompletedphaseoneofaclinicaltrialbuthasnotbeenapprovedforgeneraluse |
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| 122 | 122 | | 19bytheUnitedStatesFoodandDrugAdministrationandremainsunderinvestigationina |
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| 123 | 123 | | 20clinicaltrial[. ThetermshallnotincludeScheduleIcontrolledsubstances]; |
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| 124 | 124 | | 21 (3)"Life-threateningconditionorillness",adiseaseorcondition: |
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| 125 | 125 | | 22 (a)Inwhichthelikelihoodofdeathishighunlessthecourseofthediseaseor |
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| 126 | 126 | | 23conditionisinterrupted;and |
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| 127 | 127 | | 24 (b)Withpotentiallyfataloutcomes,wheretheendpointofclinicaltrialanalysis |
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| 128 | 128 | | 25issurvival; |
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| 129 | 129 | | 26 (4)"Severelydebilitatingconditionorillness",adiseaseorconditionthatcauses |
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| 130 | 130 | | 27majorirreversiblemorbidity; |
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| 131 | 131 | | 28 (5)"Terminalconditionorillness",adiseaseorconditionthatwithoutlife- |
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| 132 | 132 | | 29sustainingprocedureswillresultindeathinthenearfutureorastateofpermanent |
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| 133 | 133 | | 30unconsciousnessfromwhichrecoveryisunlikely. |
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| 134 | 134 | | 31 2.Amanufacturerofaninvestigationaldrug,biologicalproduct,ordevicemaymake |
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| 135 | 135 | | 32availablethemanufacturer'sinvestigationaldrug,biologicalproduct,ordevicetoeligible |
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| 136 | 136 | | 33patientsunderthissection.Thissectiondoesnotrequirethatamanufacturermakeavailable |
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| 137 | 137 | | 34aninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient.Amanufacturer |
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| 138 | 138 | | 35may: |
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| 139 | 139 | | HB951 4 36 (1)Provideaninvestigationaldrug,biologicalproduct,ordevicetoaneligiblepatient |
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| 140 | 140 | | 37withoutreceivingcompensation;or |
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| 141 | 141 | | 38 (2)Requireaneligiblepatienttopaythecostsoforassociatedwiththemanufacture |
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| 142 | 142 | | 39oftheinvestigationaldrug,biologicalproduct,ordevice. |
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| 143 | 143 | | 40 3.Amanufacturerofanyinvestigationaldrug,biologicalproduct,ordeviceshall |
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| 144 | 144 | | 41registerwiththedepartmentofhealthandseniorservices.BeforeNovember1,2025, |
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| 145 | 145 | | 42thedepartmentofhealthandseniorservicesshallcreatearegistryofsuch |
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| 146 | 146 | | 43manufacturersthatmanufactureanyinvestigationaldrug,biologicalproduct,or |
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| 147 | 147 | | 44devicethatinvolvesacontrolledsubstance. |
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| 148 | 148 | | 45 4.Thissectiondoesnotrequireahealthcareinsurertoprovidecoverageforthecost |
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| 149 | 149 | | 46ofanyinvestigationaldrug,biologicalproduct,ordevice.Ahealthcareinsurermayprovide |
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| 150 | 150 | | 47coverageforaninvestigationaldrug,biologicalproduct,ordevice. |
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| 151 | 151 | | 48 [4.]5.Thissectiondoesnotrequirethedepartmentofcorrectionstoprovidecoverage |
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| 152 | 152 | | 49forthecostofanyinvestigationaldrug,biologicalproduct,ordevice. |
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| 153 | 153 | | 50 [5.]6.Notwithstandinganyotherprovisionoflawtothecontrary,nostateagencyor |
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| 154 | 154 | | 51regulatoryboardshallrevoke,failtorenew,ortakeanyotheractionagainstaphysician's |
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| 155 | 155 | | 52licenseissuedunderchapter334basedsolelyonthephysician'srecommendationtoan |
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| 156 | 156 | | 53eligiblepatientregardingprescriptionforortreatmentwithaninvestigationaldrug,biological |
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| 157 | 157 | | 54product,ordevice.Actionagainstahealthcareprovider'sMedicarecertificationbasedsolely |
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| 158 | 158 | | 55onthehealthcareprovider'srecommendationthatapatienthaveaccesstoaninvestigational |
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| 159 | 159 | | 56drug,biologicalproduct,ordeviceisprohibited. |
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| 160 | 160 | | 57 [6.]7.Ifaprovisionofthissectionoritsapplicationtoanypersonorcircumstanceis |
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| 161 | 161 | | 58heldinvalid,theinvaliditydoesnotaffectotherprovisionsorapplicationsofthissectionthat |
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| 162 | 162 | | 59canbegiveneffectwithouttheinvalidprovisionorapplication,andtothisendtheprovisions |
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| 163 | 163 | | 60ofthissectionareseverable. |
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| 164 | 164 | | 61 [7.]8.Iftheclinicaltrialisclosedduetolackofefficacyortoxicity,thedrugshallnot |
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| 165 | 165 | | 62beoffered.Ifnoticeisgivenonadrug,product,ordevicetakenbyapatientoutsideofa |
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| 166 | 166 | | 63clinicaltrial,thepharmaceuticalcompanyorpatient'sphysicianshallnotifythepatientofthe |
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| 167 | 167 | | 64informationfromthesafetycommitteeoftheclinicaltrial. |
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| 168 | 168 | | 65 [8.]9.Exceptinthecaseofgrossnegligenceorwillfulmisconduct,anypersonwho |
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| 169 | 169 | | 66manufactures,imports,distributes,prescribes,dispenses,oradministersaninvestigational |
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| 170 | 170 | | 67drugordevicetoaneligiblepatient[withaterminalillness] inaccordancewiththissection |
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| 171 | 171 | | 68shallnotbeliableinanyactionunderstatelawforanyloss,damage,orinjuryarisingoutof, |
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| 172 | 172 | | 69relatingto,orresultingfrom: |
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| 173 | 173 | | 70 (1)Thedesign,development,clinicaltestingandinvestigation,manufacturing, |
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| 174 | 174 | | 71labeling,distribution,sale,purchase,donation,dispensing,prescription,administration,or |
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| 175 | 175 | | 72useofthedrugordevice;or |
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| 176 | 176 | | HB951 5 73 (2)Thesafetyoreffectivenessofthedrugordevice. |
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| 177 | 177 | | âś” |
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| 178 | 178 | | HB951 6 |
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