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December16,2009141 Northwest Point Blvd Elk Grove Village, IL 600071098Phone: 847/4344000 MsCharleneFrizzeraFax: 847/4348000 Email: kidsdocs@aap.orgActingAdministratorwww.aap.org CentersforMedicareandMedicaidServicesDepartmentofHealthandHumanServicesAttention:CMS1418PMailStopC42605Executive Committee 7500SecurityBoulevardPresident Baltimore,MD212441850Judith S. Palfrey, MD, FAAP PresidentElect Re:MedicareProgram;EndStageRenalDiseaseProspectivePaymentSystem;ProposedRule;O. Marion Burton, MD, FAAP CMS1418PImmediate Past President David T. Tayloe, Jr, MD, FAAP DearMsFrizzera:Executive Director/CEO Errol R. Alden, MD, FAAP TheAmericanAcademyofPediatrics(AAP)appreciatestheopportunitytoprovidecommentsontheNoticeofProposedRulemakingentitled“MedicareProgram;EndStageRenalDiseaseBoard of Directors ProspectivePaymentSystem;ProposedRule.”TheAcademyoffersthesecommentsontheDistrict I proposedruletoensurethatnewEndStageRenalDisease(ESRD)ProspectivePaymentSystemEdward N. Bailey, MD, FAAP policiesappropriatelyaccommodatetheuniqueaspectsofhealthcareservicesdeliveredtoSalem, MA children.District II Henry A. Schaeffer, MD, FAAP Brooklyn, NY Reducingthepediatric(<18yearsold)casemixadjustor(CMA)forfacilityreimbursementfrom1.62to1.199orbelowwillleadtoanunintendedconsequenceofDistrict III Sandra Gibson Hassink, MD, FAAP pediatricESRDpatientslosingaccesstonecessarytreatments.Wilmington, DE TheuniqueneedsofchildrenandadolescentshavebeenunderestimatedbyCMS’o District IV Francis E. Rushton, Jr, MD, FAAPESRDProposedPaymentSystem(PPS)regressionmethodology.CMSpreviouslyBeaufort, SC hasrecognizedtheincreasedcostofdialyzingchildren,bothinthegrantingofDistrict VpediatricdialysisfacilityexceptionstoreimbursementandintheprovisionoftheMarilyn J. Bull MD, FAAP temporarypediatricCMAof1.62in2005.Pediatricdialysisunits(>50%patientIndianapolis, IN <18yearsold)withexception,mostofwhichareassociatedwithchildren’sDistrict VI hospitals,weregrantedhigherfacilityratesbasedontheiractualcostsintheirMichael V. Severson, MD, FAAP Medicarecostreports,includinghigherpersonnelstaffing,highercostsofBrainerd, MN pediatricspecificdialysisdisposableequipment,andhighercostsofsupportforDistrict VII homecareofchildrenandtheircaregiverfamilies.DatafrompediatricunitsKenneth E. Matthews, MD, FAAP College Station, TX providethebestassessmentofcostsforpediatricspecificservicesUseoftheproposedpediatricCMAandeliminationofthepediatricfacilityo District VIII Mary P. Brown, MD, FAAP exceptionswillreducethecostadjustmentneededbymanypediatricfacilitiestoBend, OR remainoperational.Withoutpediatricdialysisunits,ourchildrenandadolescentsDistrict IX Myles B. Abbott, MD, FAAPwithESRDwillnothaveaccesstothespecializeddialysiscarethattheyneedandBerkeley, CA whichhasbeenthedrivingforceforimprovementinoutcomesandadvancesinDistrict Xdialysistreatmentforthisuniquegroupofpatients.John S. Curran, MD, FAAP Furthermore,theproposedlowerpediatricCMAadjustorsof1.199orlesswillbeo Tampa, FL adisincentiveforadultunitstocontinuetoprovidedialysisforthefewchildrenwhoaregeographicallyunabletobecaredforatapediatriccenter.
Pediatricpatientsaccountforjustlessthan0.6%oftheprevalentdialysispopulationandonlyabout0.2%ofdialysisMedicarebeneficiaries.Theuniqueservicesprovidedinpediatricdialysisunitsarevitalforthecareofthissmall,vulnerablepopulation.AlthoughareductioninreimbursementasproposedbyCMSwouldhaveao negligibleeffectontheMedicareprogram,thesechangescouldpotentiallydevastatetheviabilityoffacilitiesspecializinginthetreatmentofthisvulnerablepopulation.Childrenandadolescentsundertheageof18arenotyetfullydevelopedandareo dependentonadultstoprovideagespecificsupervisionandcareduringdialysistreatmentsandforhomecare.ThesmallestandyoungestchildrenrequireonetoonenurseorhomecaregivercareduringHDorPDtreatmentstoensuresafetyandefficacy.hildrenreceivingdialysisrangeinsizefrom3kgnewbornsto90kgteenagers,sooC requireawidevarietyofspecializeddialyzers,bloodlines,andothersupplies,mostofwhichareexpensiveandonlymadebyoneoratmosttwovendors.llarypediatricpersonnelarebothrequiredandessentialtopediatricdialysis,oAnci notonlyindealingwiththesmallestchildren,butalsoindealingwithadolescents,whohavesignificantproblemswithdialysis,includingbehavioraladjustment,adherencetodietaryrestrictionsandmedications,andmaintainingschoolperformance.TheproposedESRDPPSCMAforpediatricsisbasedonastatisticalregressionmodelthatisflawedforpediatricsduetothesmallnumberofpediatricpatientsusedinthedataanalysisandtomissingandincompletecostdataforpediatricdialysisunits.ThecurrentCMSmodeldoesnotfairlyrepresenttheactualdatafromcosto reportsofpediatricdialysisunitsandisdistortedbythepediatricpatientsdialyzedinadultunits,whosefacilitycostsrepresenttheadultcostsofthoseunitsandnotpediatricspecificservices.Inaddition,methodologyforestimatingseparatelybillableservicesforpediatricpatientswasbasedonasmallsamplewithlimitedstatisticalpowerandislikelymissingsignificantdatafromunderreportingofseparatepediatricclaims.Theproposedmodifierdoesnottakeintoaccountpediatricspecificcosts,coo morbiditiesandotherspecialneedsofthepediatricESRDpopulation,soisseverelyundervalued.PediatricpatientsalmostneverhavethecomorbiditiesdesignatedintheproposedESRDPPS,butdohavepediatricspecificcomorbidities,includingrenalosteodystrophy,growthretardation,developmentaldelay,deafness,seizuredisorder,raregeneticdiseasesandotherorgansystemdisorders.Dialysisnurses,dietitians,socialworkers,ChildLifeSpecialists,tutors,ando psychologistswithspecializedpediatrictrainingandexpertisearerequiredandessentialforthecareofchildrenandadolescents.CMSshoulduseasinglecategoryCMAforpediatricpatients.Usingmultiplepaymentcategoriestoadjustforage,modalityandadultcomorbiditiesunnecessarilycomplicatestheproposedESRDPPSforpediatricdialysispatients(Table33,p260).oTheproposedpediatricratesarelowestfortheyoungestpatients(<13yearsold),whichiscompletelycontrarytoanddoesnotaccountforthetechnicalcomplexityandhighcostofstaffingandspecializedsuppliesinvolvedindialyzingthisgroupofchildren.oAssigningasinglepediatricCMAregardlessofmodalitywillallowpediatricnephrologistsandfamiliestochoosetherightdialysismodalityforeachchild.Currently,about50%ofpediatricpatientsaretreatedwithhomePD.ThetechnicalaspectsofprovidinghomePDsupportforparentcaregiversandforadolescentselfcarepatientsleadtohighercostsandappearsundervaluedbythe
proposedmodalitybasedformulas.oTheacceptablecomorbiditiesstatedintheESRDPPS(diabetes,alcohol/drugdependence,etc)areforadultsanddonotoftenapplytochildren.CommonpediatricESRDcomorbiditiesarenotaddressed,includingpulmonaryhypoplasia,developmentaldelay,failuretothrive,seizuredisorder,deafness,congenitalheartdisease,othersolidorgantransplantation,andrenalosteodystrophyofgrowingbones.MostpediatricdialysispatientswouldnotbeclassifiedashavingcomorbiditiesusingtheproposedESRDPPSlist.TheAmericanAcademyofPediatricsasksthatCMSprovideamoreappropriatesinglecategoryCMAforpediatricdialysispatients.ThepediatricCMAshouldbebasedonaseparatepediatricspecificanalysisofactualcosts,includingdataforthemajorityofpatientswhoaredialyzedinpediatricdialysisunitsandincludingpediatricspecificcomorbidities,andnotontheproposedregressionmethodology,whichhasflawswhenappliedtosuchasmallpopulationwithincompletedata.WerequestthatCMSworkwithleadersofthepediatricdialysiscommunitytoo considerananalysisthatwouldincludeallaspectsofthecostforpediatricdialysispatientstodetermineanappropriatepediatricCMA.WeanticipatethatsuchananalysiswillresultinamoreaccuratepediatricCMAthancurrentlyproposed,andbemoreinlinewithreimbursingactualcoststothecountry'svitalpediatricESRDfacilities.CMSmaywanttoconsiderpostponingtheapplicationofthebundledpaymento systemtothepediatricpopulationuntilmoreaccuratedatacanbecollectedandtheactualcostsofcaringforsuchavulnerablepopulationcanbeanalyzedinmoredetailbyCMS.TheAcademyappreciatestheopportunitytoprovidecommentsontheproposedruleandlooksforwardtoworkingwithCMStoensurethattheESRDProspectivePaymentSystemaccommodatestheuniqueaspectsofhealthcareservicesdeliveredtochildren.Sincerel ,
JudithS.Palfrey,MD,FAAPPresidentJSP/sk