Summary of Key Matters for Consideration by the Applicant

1159

Final Decision Analytic Protocol (DAP) to guide the assessment of palliative medicine professional attendance items

June 2012

Table of Contents

MSAC and PASC

Purposeofthisdocument

Summary of key matters for consideration by the applicant

Purpose of application

Background

Currentarrangementsforpublicreimbursement

Intervention

Description

HISTORY

EXAMINATION

DIAGNOSIS

MANAGEMENT PLAN

Prerequisites

REFERRAL

TRAINING

Co-administeredandassociatedinterventions

Listings proposed for MSAC consideration

ProposedMBSlisting

Clinicalplaceforproposedintervention

Clinical claim

Economic evaluation

MSAC and PASC

TheMedical ServicesAdvisoryCommittee(MSAC)is anindependentexpertcommitteeappointedby theMinisterforHealth and Ageing(the Minister)tostrengthenthe roleof evidenceinhealthfinancing decisionsinAustralia.MSACadvisestheMinisteron theevidencerelatingtothesafety,effectiveness, andcost-effectivenessof newandexistingmedical technologiesandproceduresandunderwhat circumstances public funding should besupported.

TheProtocol AdvisorySub-Committee(PASC)is astandingsub-committee ofMSAC.Itsprimary objectiveisthedeterminationofprotocolstoguideclinicalandeconomicassessmentsof medical interventionsproposed forpublic funding.

Purposeofthisdocument

Thisdocumentisintendedtoprovideadecisionanalyticprotocol (DAP)thatwillbeusedtoguidethe assessment of an intervention for a particular population of patients.

Theprotocol guidingtheassessment of healthinterventionsare typicallydevelopedusingthewidely accepted“PICO”approach. ThePICOapproachinvolvesacleararticulationofthefollowingaspects of the question for public funding the assessment is intended toanswer:

Patients –specificationofthecharacteristicsofthepatientsinwhomtheinterventionis to be considered for use

Intervention–specificationof the proposed intervention and how it is delivered

Comparator – specification of the therapy most likely to be replaced by the proposed intervention

Outcomes –specificationofthehealthoutcomesandthehealthcareresourceslikelytobe affected by the introductionof the proposed intervention

However, as discussed in detail on p15 below, in the case of palliative medicine professional attendance items, PASC resolved that the adoption of the standard PICO approach was not appropriateasan assessmentfocussed onsuch anapproachmay besonarrowthatit wouldnotbe informativeto MSAC.

Summaryofkeymattersforconsiderationbythe applicant

ThePASCrequeststhattheapplicantnotethefollowingissuesandaddresstheseissuesinits assessment:

• Thewordingoftheitemstobeproposedshouldincludesomespecificationoftheservicesthat are expected to be delivered in a structured palliative medicine attendance for complex assessmentandmanagementof,andinareview of,apatientrequiringpalliativecare services (i.e., to ensure that the intervention delivered under the MBS item is as described in the section titled“Intervention-Description”onpp.11-13below andasrequiredtosatisfythePalliative Care Australiastandards).ThewordingforMBSItems132and133shouldbemodifiedsothatthe specific services that are expected to bedelivered in a palliative care setting arereflected.
• Theassessmentshouldpresenttheoverallbodyofevidencethatcouldinformajudgementasto theoverallcomparativeeffectiveness,safetyand“value”(bothto patientandcarer)ofamodelof care involving structured palliative medicine attendances for complex assessment and managementofpatients andforfollow-upreviewofthesepatients. Whereinformation was availabletoallowacomparisonofsuchamodelofcareversusalternativemodelsofcare(e.g., themodelofcarethatprevailedatthetimetheinitialitemsforpalliativecareweremade availableontheMBS,oramodelofcareinvolvingunstructuredattendancesthatrespondto issuesastheyareraisedbyapatient),then theassessmentshouldincludesuchcomparative analyses.
• Onthebasisofthelikelyclaimsofpotentialclinicalsuperiorityfortheproposedmodelofcare comparedwithalternative models ofcare,PASCconsideredthat anassessmentshouldpresent appropriate comparative cost-effectiveness analyses. Although incremental cost-effectiveness ratios based on quality-adjusted survival (i.e., results of comparative cost-utility analyses) are considereddesirablefordecision-making,PASCnotedthatitisimportant torecognisethattherea thereisoften trade-offbetweenthemost appealing outcomeuponwhichtobase the economic evaluationfromatheoreticalpoint of viewand thedegreeof uncertaintyintheestimateof incremental cost-effectivenessgenerated.Extrapolation ofoutcomesbeyond theevidence in this setting ofpalliativecareislikelytobeassociated with theintroductionof considerableuncertainty inestimatesofincrementalcost-effectivenessthatmaybegenerated.Giventhedifficultiesthat arelikelytobeencounteredinextrapolatingfromotheroutcomestoimpactonqualityoflife, PASCconsideredthatthepresentationofother typesofeconomicanalyses(e.g.,cost consequencesandcost-effectiveness analyses),inadditiontocost-utilityanalysis(ifitcanbe conducted),wouldbeappropriateinthecaseofstructuredpalliativemedicineattendancesfor complexassessment and reviews.
• Broaderconsiderationsbesidestheimpactonapalliativecarepatient’squality-adjustedsurvival couldbe takenintoaccountin an assessment supportingtheavailability of additional palliative medicineMBSitems.For example,aneconomicanalysismayalsoincorporatecostsandbenefits associatedwithtransferof servicesdeliveredunderthepublicsystemtotheprivatesystemand alsocostsandbenefitsassociatedwith expansion ofavailabilityofpalliative medicineservices. Also, impactsof a change to the model of careon carers of patientsshould be considered.

Purpose of application

Anapplicationrequestingthelistingoffourtime-tieredprofessionalattendance(consultation)items onthe MBS,that areintendedto allowforpreparationand reviewofcomplextreatmentand managementplansbypalliativemedicinespecialists,hasbeenprogressedbytheDepartmentof Health andAgeing(DoHA)inconsultationwith the Australian & NewZealand Society ofPalliative Medicine (ANZSPM).

PASCnotedthatthecommentsreceivedfromtheANZSPMduringthepublicconsultationperiodon thisDAPdidnotappeartobesupportiveofthetime-tiereditemsthathadbeenproposedbythe Department andinstead reiteratedthe ANZSPM’spositionthatitspreference wasfortheadditionof itemsthataresimilartoMBSItems132and133thatareavailabletoconsultantphysicianstoallow forcomplexassessmentandmanagementofpatients(requiringanattendance≥45minutes)andfor follow-upreviewofthesepatients(requiringanattendance≥ 30minutes)toensurethattreatment andcareplansarekeptalignedwiththechangingneedsofthepatientandtheircaregiver/sand familyand thechangingphaseof the patient’sillness.A setofitems for attendances at consulting roomsorinahospitalandasetforattendancesat aplaceotherthanconsultingroomsorhospitals) were proposed.

PASCdeterminedthattheDAPshouldberevisedsothatthe intervention ofinterest relatedto structuredpalliativemedicineattendances(eitherinconsultingrooms,hospitals,or otherplaces)for complexassessmentandmanagementofpatients andforfollow-upreviewofthesepatients,as requested by the ANZSPM, rather than the time-tiered items proposed in the Consultation DAP.

Background

Currentarrangementsforpublicreimbursement

Foramedicalpractitioner toberecognisedby AustralianMedical CouncilandMedicareAustralia as beingapalliativemedicinespecialists/hemustbe afellowoftheAustralasianChapterofPalliative Medicine (FAChPM).

Thereare currently six palliative medicine professionalattendance items available on theMBS:

• threeitemsforprofessionalattendancesatconsultingroomsorhospital(Items3005,3010,and

3014); and

• threeitemsforprofessionalattendancesataplaceotherthanconsultingroomsorhospital(Items

3018,3023,and3028);PASCnotedthattheschedulefeesforattendancesintheselocationsare between 21% and 85%higher than for attendances in doctors' rooms or in hospital.

In addition, there are twelve palliativemedicine items for case conferencing:

• threetime-tiereditemsfororganisationandco-ordinationofacommunitycaseconferencebya palliative medicine specialist (Items 3032, 3040,and 3044)
• threetime-tiereditemsforparticipationinacommunitycaseconferencebyapalliativemedicine specialist (Items 3051, 3055, and 3062)

• threetime-tiereditemsfororganisationandco-ordinationofadischargecaseconferencebya palliative medicine specialist (Items 3069, 3074,and 3078)
• threetime-tiereditemsforparticipationinadischargecaseconferencebyapalliativemedicine specialist (Items 3083, 3088, and 3093).

Detailsof these items (asper the May 2012 edition ofthe MBS)are provided in Table 1.

Table 1:Current MBS item descriptorsfor professional attendance items available for palliative medicine specialists

Table 1:Current MBS item descriptorsfor professional attendance items available for palliative medicine specialists

Table 1:Current MBS item descriptorsfor professional attendance items available for palliative medicine specialists

TheANZSPM claims thatmanagement ofpalliative medicinepatientshasbecomemore complexsince initialitemsforpalliative carewereintroduced.A complexassessmentand managementplanare required,for example,tocomplywithpalliativecarecapabilityand qualityframeworkservice provision (suchasPalliativeCareAustraliastandards)andtocomplywith medicaldevelopmentsin palliative medicine (such as advanced care planning and end-of-life decision making). It is claimed that preparationofatreatmentandmanagementplantypicallytakesaround60minutes.InNovember

2007, items as shown inTable 2 were introduced thatallow for complex assessment and management

ofpatientshowevertheseitems(MBSitem132andfollow-upreviewitem133)arerestrictedsuch thatthey areonlyavailabletoconsultantphysicians(i.e.,tofellows oftheRoyal AustralianCollegeof Physicians[FRACPs]).Aminorityofpalliativemedicinespecialists holdsuch afellowship;themajority arefellows onlyoftheAustralasianChapterofPalliative Medicine(AChPM). TheANZSPM provided advicethat,asofDecember2010,therewere282recognisedpalliativemedicinespecialists.Ofthese,

6%holdFRACPonly,26%holdFRACPandFAChPM andtheremaining68%holdFAChPMonly.Thus,onlyaminorityofpalliativemedicinespecialistsare abletoclaimtheseitems. Thisinconsistencyin access to MBS complex assessment and management items causes some concern among the palliativemedicinepractitionerbaseandtheANZSPMhasexpressedthatitbelievestheseitems shouldbeavailableto allpalliativemedicinespecialistswhethertheyholdFRACP,FAChPMor FRACPFAChPM. Theproposeditemsareintendedtoaddress thisinconsistency.ItwasnotedbyPASCthat MBSitems132and133arelimitedtoservicesdeliveredinthesurgeryorhospital.Theproposed items are notrestricted toprofessional attendancesin thesesettingsbutpermitprofessional attendancesinallsettings(i.e.,includinghomesand residentialagedcarefacilities).PASCconsidered that,giventhepoorhealthstatusof patientsrequiringpalliativeservices,itwasappropriatethat differentialMBSpalliativemedicineitemsshouldbeavailablefordeliveryofmedicalservicesin settingsother thantheconsultingroomsorhospital setting(e.g.,toincludenursinghome,hospiceor patient's ownhome).

Table 2:Current MBS item descriptorsfor items available for complexassessment and managementofpatients in surgeryor hospital settings

Category 1 – Professional attendances

MBS Item 132

Thetitlewouldneedtobe changed to:

PALLIATIVE MEDICINE SPECIALIST- REFERRED PATIENTTREATMENT AND MANAGEMENT PLAN, SURGERY, HOSPITALORHOME

Professional attendance of at least 45 minutes duration for an initial assessment of a patient with at least two morbidities (this can includecomplex congenital, developmental and behaviouraldisorders),where the patient is referred by a medical practitioner, and where

a)assessmentis undertaken that covers:

-a comprehensive history, including psychosocialhistory and medication review;

-comprehensivemulti or detailedsingle organ system assessment;

-the formulation of differential diagnoses; and

b)a consultant physician treatmentand management plan of significant complexityis developed andprovided to the referring practitioner that involves:

-an opinion on diagnosis and risk assessment

-treatment options and decisions

-medication recommendations

Not being an attendance on a patient in respect of whom, an attendance under items 110, 116 and 119 has been received on the same day by the same consultant physician.

Not being an attendance on the patient in respect of whom, in the preceding 12 months, paymenthas been made under this item for attendance by the same consultantphysician.

Fee:$259.00Benefit: 75%= $194.2585%= $220.15 (See para A12 of explanatory notes to this ategory)

Table 2:Current MBS item descriptorsfor items available for complexassessment and managementofpatients in surgeryor hospital settings

Category 1 – Professional attendances

MBS Item 133

CONSULTANTPHYSICIAN(OTHER THAN IN PSYCHIATRY) REVIEW OF REFERRED PATIENT TREATMENTAND MANAGEMENT PLAN- SURGERY ORHOSPITAL

PALLIATIVE MEDICINE SPECIALIST- REVIEW OFREFERRED PATIENT TREATMENT AND MANAGEMENT PLAN, SURGERY,HOSPITALOR HOME

Professional attendance of at least 20 minutes duration subsequent to the first attendance in a single course of treatment for a review of apatient with at least two morbidities (this can include complex congenital, developmental and behavioural disorders), where

a)a review is undertaken that covers:

-review of initial presenting problem/s and resultsof diagnosticinvestigations

-review of responses to treatment and medicationplans initiated attime of initial consultation comprehensivemulti or detailedsingle organ system assessment,

-review of original and differentialdiagnoses; and

b)a modified consultant physician treatment and management plan is provided to the referring practitioner that involves, where appropriate:

-a revised opinion on the diagnosis and risk assessment

-treatment options and decisions

-revised medication recommendations

Not being an attendance on a patient in respect of whom, an attendance under item 110, 116 and 119 has been received on the same day by the same consultant physician.

Being an attendance on a patient in respect of whom, in the preceding 12 months, payment has been made under item

132 by the sameconsultant physician, payable nomore than twice in any 12 monthperiod.

Fee:$129.65Benefit: 75%= $97.2585%= $110.25 (See para A12 of explanatory notes to this Category)

Intervention

Description

TheACHPMproposedthatanassessmentsupportingMBSlistingofitemsthatwould allowfor preparation and review of complex treatment and management plans by palliative medicine specialists should besubmitted toMSAC.

Theapplicationforan assessment submittedtoPASCprovidedageneraldescriptionoftheproposed intervention. Theapplicationnotesthatpalliativemedicineisthe studyandmanagementofpatients withactive,progressive,faradvanceddisease,forwhotheprognosisislimitedandthefocusofcare isqualityoflife.Italsonotesthatanassessment of apatientby apalliativemedicinespecialistwould involve: ascertainmentof apatient’scurrentactive medicalproblems andrecordingofthepatient’s pastmedical history,conductofamedicationreview,makingadvancedcareplanningarrangements, assessment ofcurrent and previousphysicalandpsychological function.Amanagementplan wouldbe developed,based oninformationprovidedbythehistoryandexamination ofthe patient,with theplan beingexplained,and/orprovidedtothepatient,orwhereappropriate,to theirfamilyorcarer(s).The palliativemedicinespecialisttreatmentandmanagementplan shouldaddress any specific questions andissuesthatwereraisedbythereferringpractitioner.Awritten reportofthe assessment, including themanagementplan,shouldbeprovidedtothereferringpractitionerwithinamaximumoftwo

weeks aftertheassessment.Morepromptverbal communicationmaybeappropriate.Thepalliative medicine specialist would then provide follow-up review, treatment and management (via a number of consultations, as required).

Furtherdetail onvariousaspectsof the proposedintervention areprovidedas follows. PASC noted that,ideally,theMBSlistingwouldoutlinetheservicesthatareexpected tobedeliveredinthe preparation of a complextreatment andmanagementplan.

HISTORY

The palliative medicine specialist treatment and management plan should encompass a comprehensivepatienthistory,whichaddresses allaspectsofthepatient'shealth,including psychosocial history,pastclinically relevantmedicalhistory,anyrelevantpathology resultsif performed, and a review of medication and interactions. There should be a particular focus on the presenting symptoms andcurrentdifficulties,includingprecipitatingandongoingconditions.The results of relevant assessments by other health professionals, including GPs and/or specialists, includingrelevantcareplansorhealth assessmentsperformedbyGPsundertheEnhancedPrimary Care and Chronic DiseaseManagement, should also be noted.

EXAMINATION

Acomprehensivemedicalexaminationmeansafull multi-systemordetailedsingleorgansystem assessment. Theclinically relevantfindingsoftheexaminationshouldberecordedinthemanagement plan.

DIAGNOSIS

Thisshouldbebasedoninformationobtainedfromthehistoryandmedicalexaminationofthe patient.Thelistofdiagnosesand/orproblemsshouldformthebasisofanyactionstobetakenas a resultofthe comprehensiveassessment.Insomecases,thediagnosismaydifferfromthatstatedby thereferring practitioner,and anexplanation ofwhythediagnosisdiffers shouldbeincluded. The report shouldalso providea risk assessment, management options and decisions.

MANAGEMENT PLAN

TREATMENTOPTIONS/TREATMENTPLAN

Thepalliativemedicinespecialisttreatmentandmanagementplanshouldincludeaplanned follow-upof issuesand/orconditions,includinganoutlineof therecommendedintervention activitiesand treatmentoptions.Considerationshouldalsobegiventorecommendationsfor allied health professional services, where appropriate.

MEDICATIONRECOMMENDATIONS

Providerecommendationsforimmediatemanagement,including thealternativesoroptions.This shouldincludedoses,expectedresponsetimes,adverseeffectsandinteractions,andawarningof any contra-indicated therapies.

SOCIALMEASURES

Identifyissueswhichmayhavetriggeredor arecontributingtotheprobleminthefamily, workplaceor othersocialenvironmentwhichneed tobeaddressed,includingsuggestionsfor addressing them.

OTHERNON-MEDICATIONMEASURES

Thismay includeother optionssuch anyrehabilitationrecommendations and discussion of any relevant referrals to otherhealth providers.

 INDICATIONSFORREVIEW

Itisanticipatedthatthemajorityofpatientswillbeabletobemanagedeffectivelybythe referringpractitioner using thepalliative medicine specialisttreatment andmanagementplan.If thereareparticularconcernsabouttheindicationsorpossibleneedforfurtherreview,these should be noted in the palliative medicinespecialist treatment andmanagementplan.

 LONGERTERM MANAGEMENT

Providealongertermpalliativemedicinespecialisttreatment andmanagementplan,listing alternativemeasures that mightbetakeninthefutureiftheclinicalsituationchanges. This might bearticulatedasanticipatedresponse times,adverseeffectsandinteractionswiththepalliative medicine specialist treatment and management plan options recommended under the palliative medicine specialist treatment and management plan.

CARERSUPPORTPLAN

Provideappropriatesupport,trainingandresourcestoensurethatcarersareabletocarryout their end of life care responsibilities effectively. Provide care and support to deal with bereavementand grief.

BEREAVEMENTPLAN

Providebereavement supportto allrelevantfamily members,bothbefore and afterthepatient’s death,to supportthemthroughtheacutephase ofgrief. Thiswillincluderoutine andongoing risk assessment andestablishmentofpartnerships withlocalcommunitynetworksto enhance bereavement support.Peoplewithcomplicatedgrief orprolonged needs mayneedtobereferred to specialist bereavement counselling orpsychiatricservice

SPIRITUALASSESSMENT

Ensurethatspiritual support through pastoral carers,asappropriate, isarranged.

AlthoughtheANZSPMadvisedthattheusualtime neededtoconductanassessmentanddrafta managementplanisaround60minutes,italso advisedthatboth initialand follow-upconsultations may be eithershorter or longer, depending on a patient’s needs and depending on the patient’s health status.Onthisbasis,DoHA (representingtheapplicant)suggested thatthe application should request MBSlistingof asetoftime-tiereditems (as opposedtoitemsspecificallyallowingforthepreparation andreviewofcomplextreatmentand managementplans),withspecialists beingabletobillthe relevantitembasedonthetimespent withpatients.Itwassuggestedthattheproposedtime-tiered itemswouldallowFAChPMstohaveaccessto adequatereimbursementfortheactivity ofpreparing andreviewingcomplextreatmentandmanagementplansaswouldbeprovided byMBSitem 132and follow-upreviewitem133(detailedinTable2)which areavailabletoconsultantphysicians(i.e.,to FRACPs).

As discussed in the section titled ‘Purpose of application’ on p.4 above, PASC noted that the comments received from the ANZSPM during the public consultation period on this DAP did not appear to be supportive of thetime-tiereditemsthathadbeenproposedbytheDepartment andinstead reiterated theANZSPM’spositionthatitspreferencewasfortheinclusionofitemsthataresimilartoMBSItems