About the 2022 Edition
OIGsTopUnimplementedRecommendations:SolutionsToReduceFraud,Waste,andAbuseinHHS
ProgramsisanannualpublicationoftheDepartmentofHealthandHumanServices(HHSorthe
Department),OfficeofInspectorGeneral(OIG). Inthisedition,wefocusonthetop25unimplemented
recommendationsthat,inOIGsview,wouldmostpositivelyaffectHHSprogramsintermsofcostsavings,
publichealthandsafety,andprogrameffectivenessandefficiency,ifimplemented. These
recommendationscomefromOIGauditsandevaluationsperformedpursuanttotheInspectorGeneral
Actof1978,asamended. ThispublicationisresponsivetorequirementsoftheInspectorGeneralAct.1
Thiseditionbeginswithalistofthetop25unimplementedrecommendations,groupedbythecognizant
HHSoperatingdivision(OpDiv). Foreachofthetop25recommendations,weoutlinekeyOIGfindings
andtheOpDivsreportedprogresstowardimplementation. Pleasenotethatthelistoftop25
recommendationsisnotlimitedto25distinctrecommendationsbutmaycompriseasetofpriority
recommendationsrepresentingthemostsignificantopportunitiestopositivelyimpacttheDepartments
programs. InAppendixA,weincludealistofallunimplementedOIGrecommendationsthatrequire
legislativeaction. InAppendixB,weincludeabroaderlistofOIGssignificantunimplemented
recommendationsissuedthroughJuly1,2022.
Additionally,inAppendixCweincludealistof72significantrecommendationsreportedinthe2021
editionofthispublicationthathavesincebeenimplementedorclosed.2 Thislistincludesseveraltop25
recommendationsfromthe2021editionthatwereimplementedbyOpDivsincriticalareas,suchas
ensuringthatbeneficiariesareeducatedaboutaccesstomedicationassisteddrugsandnaloxonetotreat
opioidusedisorderandarecommendationonimprovingcybersecurityrequirementsforHHSweb
applications.
Inadditiontothispublication,OIGreportsannuallyonthetopmanagementandperformancechallenges
facingHHS.3 ThesechallengesariseacrossHHSprogramsandcovercriticalHHSresponsibilitiesthat
includedeliveringqualityservicesandbenefits,exercisingsoundfiscalmanagement,safeguardingpublic
healthandsafety,andenhancingcybersecurity. Wehighlightmanagementandperformancechallenges
facingeachOpDivthroughoutthisdocument.
Thetop25unimplementedrecommendationsinthiseditionderivefromauditsandevaluationsissued
throughDecember31,2021. Assuch,manyoftheserecommendationspredatetheCOVID-19public
healthemergency. AsofNovember2022,OIGhad49auditsandevaluationsunderwayrelatedto
COVID-19responseandrecovery,whichmayresultinrecommendationsthatappearinfutureeditions.
OIGcontinuestoadvancethefourgoalswithrespecttoHHSsCOVID-19responseandrecovery. These
goalsareto:(1)protectpeople,(2)protectfunds,(3)protectinfrastructure,and(4)promote
effectivenessofHHSprograms,nowandintothefuture. OIGscompletedandongoingworkrelatedto
COVID-19isavailableviatheCOVID-19Portalonourwebsite.
1P.L.No.113-235(Dec.16,2014). TheInspectorGeneralActrequiresFederalinspectorsgeneraltoidentifysignificant
recommendationsdescribedinpreviousSemiannualReport(s)toCongresswithrespecttoproblems,abuses,ordeficienciesfor
whichcorrectiveactionhasnotbeencompleted.
2OIG,2021OIGsTopUnimplementedRecommendations:SolutionsToReduceFraud,Waste,andAbuseinHHSPrograms,Oct.
2021. Availableathttps://oig.hhs.gov/reports-and-publications/compendium/files/compendium2021.pdf.
3OIG,2022TopManagementandPerformanceChallengesFacingHHS,Nov.2022. Availableathttps://oig.hhs.gov/reports-
and-publications/top-challenges/2022/2022-tmc.pdf. Formoreinformation
MoreinformationonOIGswork,includingthereportsmentionedinthispublication,appearsonour
websiteathttps://oig.hhs.gov/. ForquestionsaboutOIGsTopUnimplementedRecommendationsand
thelistsoflegislativeandsignificantunimplementedrecommendations,pleasecontactPublicAffairsat
Public.Affairs@oig.hhs.gov. TABLEOFCONTENTS
TOP25UNIMPLEMENTEDRECOMMENDATIONS 2
CMSPROTECTINGPATIENTS(CROSS-CUTTING) 5
CMSMEDICAREPARTSAANDB 11
CMSMEDICAREPARTSCANDD 15
CMSMEDICAID 20
ADMINISTRATIONFORCHILDRENANDFAMILIES(ACF) 25
INDIANHEALTHSERVICE(IHS) 28
NATIONALINSTITUTESOFHEALTH(NIH) 30
FOODANDDRUGADMINISTRATION(FDA) 32
GENERALDEPARTMENTAL 34
APPENDIXA:UNIMPLEMENTEDLEGISLATIVERECOMMENDATIONS 38
APPENDIXB:SIGNIFICANTUNIMPLEMENTEDRECOMMENDATIONS 43
APPENDIXC:IMPLEMENTED&CLOSEDRECOMMENDATIONSREPORTEDIN2021EDITION 79 Top 25 Unimplemented Recommendations
Detailsforeachofthefollowingrecommendationsareinthesectionofthisdocumentthatfollows. We
notethatthenumberingoftherecommendationsdoesnotnecessarilysignalprioritization.
CentersforMedicare & Medicaid Services(CMS)Protecting Patients
(Cross-Cutting)
1. CMSshouldtakeactionstoensurethatincidentsofpotentialabuseorneglectofMedicareand
Medicaidbeneficiaries,includingthoseinnursinghomesandhospicecareaswellaschildren
enrolledinMedicaid,areidentifiedandreported.
2. CMSshouldaddressinappropriatenursinghomedischargesthroughtraining,byimplementing
deferredinitiatives,andbyassessingtheeffectivenessofitsenforcementagainstinappropriate
facility-initiateddischarges.*
3. CMSshouldtakestepstoreducethecostsforMedicareanditsbeneficiariesbypromotingtheuse
oflesscostly,clinicallyappropriatedrugs.
4. CMSshouldimproveandimplementsystemeditprocessesforitsdurablemedicalequipment
(DME)Medicarecontractorstopreventimproperpaymentsforservicesprovidedtohospice
beneficiaries.*
CMSMedicare Parts A and B
5. CMSshouldtakethenecessarystepstoestablishaninpatientrehabilitationfacility(IRF)transfer
paymentpolicyforearlydischargestohomehealthcareandreevaluatetheIRFpaymentsystem,
whichcouldincludeseekinglegislativeauthoritytomakeanychangesnecessarytomoreclosely
alignIRFpaymentratesandcosts.
6. CMSshouldseeklegislativeauthoritytocomprehensivelyreformthehospitalwageindexsystem.
7. CMSshouldrecoveroverpaymentsof$1billionresultingfromincorrectlyassigningsevere
malnutritiondiagnosiscodestoinpatienthospitalclaims,ensurethathospitalsbillappropriately
movingforward,andconducttargetedreviewsofclaimsatthehighestseveritylevelthatare
vulnerabletoupcoding.
CMSMedicare Parts C and D
8. CMSshouldtakestepstoincreaseaccesstotreatmentsforopioidusedisorder.
9. CMSshouldmonitorandprovidetargetedoversightforMedicareAdvantageOrganizations(MAOs)
thathadadisproportionateshareofrisk-adjustedpaymentsfromchartreviewsandhealthrisk
assessments(HRAs).
10. CMSshouldrequireMAOstosubmitandencourageMAOstoprovideprogramoversightbasedon
anorderingprovidersnationalprovideridentifier(NPI)onencounterrecordsforDME,prosthetics,
orthotics,andsupplies,aswellasforlaboratory,imaging,andhomehealthservices.
11. CMSshoulddevelopandexecuteastrategytoensurethatPartDdoesnotpayfordrugsthatshould
becoveredbythePartAhospicebenefit.
2 CMSMedicaid
12. CMSshouldensurethatStatesreportingofnationalMedicaiddataiscomplete,accurate,and
timely.
13. CMSshouldmonitornationalperformancedataforbloodleadscreeningtestsforchildrenand
targeteffortstowardlow-performingStatestodevelopactionplansforincreasingtheprovisionof
bloodleadscreeningtests.*
14. CMSshoulddeveloppoliciesandprocedurestoimprovethetimelinessofrecoveringMedicaid
overpaymentsandrecoveruncollectedamountsidentifiedbyOIGsaudits.
15. CMSshouldimproveMedicaidmanagedcareorganizations(MCOs)identificationsandreferralsof
casesofsuspectedfraudorabuse.
16. CMSshouldidentifyStateswithlimitedavailabilityofbehavioralhealthservicesanddevelop
strategiesandshareinformationtoensurethatMedicaidmanagedcareenrolleeshavetimely
accesstotheseservices.
Administration forChildrenand Families(ACF)
17. ACFshouldimproveaccesstoappropriatementalhealthtreatmentservicesforunaccompanied
childrenandtakeallreasonablestepstominimizetheamountoftimethattheyremaininORRs
custody.
18. ACFandHHSshouldimprovetheiroperational,management,andcommunicationsystemsto
betteraddressthesafetyandsecurityneedsofunaccompaniedchildren.
19. ACFshoulddevelopacomprehensivestrategytoimproveStatescompliancewithrequirements
relatedtotreatmentplanningandmedicationmonitoringforchildreninfostercarewhoare
prescribedpsychotropicmedication.
Indian HealthService (IHS)
20. Asamanagementpriority,IHSshoulddevelopandimplementastaffingprogramforrecruiting,
retaining,andtransitioningstaffandleadershiptoremotehospitals.
NationalInstitutesofHealth(NIH)
21. NIHshouldcontinuetobuildonitseffortstoidentifyandmitigatepotentialforeignthreatsto
researchintegrity.
Food and Drug Administration (FDA)
22. FDAshouldimproveitsuseofRiskEvaluationandMitigationStrategies(REMS)byenhancingthe
assessmentreviewprocess,ensuringthatassessmentreviewsaretimely,andstrengtheningREMS
tobetteraddresstheopioidcrisis.
GeneralDepartmental
23. HHSshouldensureithaseffectiveresponseplansandprovidesnecessaryguidancetoeffectively
respondtodomesticandinternationalpublichealthemergencies.
3 24. HHSshouldimproveadministrationandmanagementofcontractsrelatedtoinherently
governmentalfunctionsandpersonalservices. HHSshouldalsoprovidetrainingtopolitical
appointeesandseniorleadersrelatedtocontractadministration.
25. HHSshouldensurethatcybersecurityincidentresponsecapabilitiesarefullyimplementedacross
theDepartment.
*TheserecommendationsappearonOIGsTop25listforthefirsttimeinthisedition.
4 
CMS Protecting Patients (Cross-Cutting)
CMSoverseesthetwolargestFederalhealthcareprograms,Medicare RelevantTopManagementand
andMedicaid,aswellastheChildrensHealthInsuranceProgram PerformanceChallenges(TMCs):
(CHIP)andHealthInsuranceMarketplaceprograms. Morethan145  SafeguardingPublicHealth
millionbeneficiariesormorethan43percentofAmericansrelyon  SafeguardingtheWell-Beingof
theseprogramsfortheirhealthinsuranceincludingseniorcitizens, HHSBeneficiaries
individualswithdisabilities,low-incomefamiliesandindividuals,and  EnsuringtheFinancialIntegrity
individualswithend-stagerenaldisease. CMSprovidesdirectionand ofHHSPrograms
technicalguidancefortheadministrationoftheFederalefforttoplan,
develop,manage,andevaluatehealthcarefinancingprogramsandpolicies. OIGiscommittedto
promotingpositivechangethathelpsCMSimproveitsprogramsandtoensuringthehealthandsafetyof
thepeopleservedbythem.
Top Unimplemented Recommendations
CMS should take actions to ensure that incidents of potential abuse or neglect of
1.
Medicare and Medicaid beneficiaries, including those in nursing homes and
hospice care aswell as children enrolled inMedicaid, are identified and reported.
Key OIG Findings
Anestimatedoneinfivehigh-riskhospitalemergencyroomMedicareclaimsfortreatmentprovidedin
2016resultedfrompotentialabuseorneglectofbeneficiariesresidinginskillednursingfacilities(SNFs).
SNFsfailedtoreportmanyoftheseincidentstoStateSurveyAgencies,andseveralagenciesfailedto
reportsomefindingsofsubstantiatedabusetolocallawenforcementagencies. Additionally,CMSdoes
notrequireStateSurveyAgenciestorecordandtrackallincidentsofpotentialabuseorneglectand
relatedreferralsmadetolawenforcementandotheragencies. Inanotherreport,weidentified34,664
Medicareclaimsthatcontaineddiagnosiscodesindicatingthetreatmentofinjuriespotentiallycausedby
abuseorneglectofbeneficiariesfromJanuary2015throughJune2017;anestimated30,754ofthese
claimsweresupportedbymedicalrecordsthatcontainedevidenceofpotentialabuseorneglect.
AdditionalOIGworkidentifiedcasesofpotentialabuseofMedicarebeneficiariesinhospicecareandthat
hospicesfailedtoactinsomeinstances. Thesecasesrevealvulnerabilitiesinbeneficiaryprotectionsthat
CMSmustaddresstobetterensurethatbeneficiaryharmisidentified,reported,addressed,and
ultimatelyprevented.
WeusedMedicaidclaimsdataforemergencyroomservicestoidentifyincidentsofpotentialchildabuse
orneglect. Weestimatedthatofthe29,534childreninMedicaidwithemergencyroomclaimsthat
includedcertaindiagnosiscodesindicativeofpotentialabuseorneglect,themedicalrecordsfor29,260
ofthesechildrenincludedevidenceofincidentsofpotentialchildabuseorneglect. Furthermore,we
5 estimatedthat3,928oftheincidentsassociatedwiththesechildrenwerenotreportedtochildprotective
services. Wealsodeterminedthatmostincidentsofpotentialchildabuseorneglectidentifiedinour
sampleoccurredinfamiliarsettingsinvolvingperpetratorsknowntothevictims. CMSdidnotidentify
similarincidentsofpotentialchildabuseorneglectduringthesameperiodorencouragetheStatesto
identifytheincidents. Furthermore,wefoundinsomeofthecasesofbeneficiaryharmwereviewedthat
beneficiarieshadbeenseriouslyharmedwhenhospicesprovidedpoorcareorfailedtoactincasesof
abuse. ThesecasesrevealvulnerabilitiesinbeneficiaryprotectionsthatCMSmustaddresstobetter
ensurethatbeneficiaryharmisidentified,reported,addressed,andultimatelyprevented.
Progressin ImplementingtheRecommendation
WithrespecttousingMedicareemergencyroomclaimstoidentifypotentialabuseorneglect,CMS
indicateditwasintheprocessofrevisingitsinterpretiveguidanceandthattherevisionswillclarify
existingguidanceonreportingviolations. CMSstateditisalsointheprocessofrevisingitsinstructionsto
surveyagenciestoensurethatcomplaintsofabuseandneglectaretrackedandreferredappropriately.
IntheMedicarehospicesetting,CMSindicatedthatStateSurveyAgenciesmusthaveacomplainthotline
thatincludescollectingandmaintaininghospicecomplaintsbasedontheConsolidatedAppropriations
Actof2021. CMSdevelopedandpublishedavideotoeducatethepubliconhowtofilecomplaintsabout
healthcaretreatmentissuesincludingpoorqualityofcare,patientrights,andabuse. Additionally,CMS
indicatedthatitcontinuestostrengthenguidanceforsurveyorstoreportcrimestolocallaw
enforcementagencies. CMShasnotcommittedtorevisingtheConditionofParticipationsregardingthe
reportingofabuse,neglect,andotherharm,butisplanningtoaddnewinterpretiveguidancefor
hospicesregardingreporting.
RegardingpotentialchildabuseandneglectofchildreninMedicaid,CMSstatedthatitreviewedexisting
FederalrequirementstoreportsuspectedchildabuseandneglectofMedicaidbeneficiariesandassessed
theirhospitalConditionsofParticipationandinterpretiveguidanceforopportunitiestostrengthenthe
currentlanguageinordertoaddressreportingofsuspectedabuseandneglecttoappropriateauthorities.
However,CMSdeterminedthatthecurrentFederalrequirementsaresufficientandthatnofurther
actionisrequiredfromCMS.
Relevant Reports: A-01-16-00509(June2019);A-01-17-00513(June2019);OEI-02-17-00021(July
2019);A-01-19-00001(July2020);A-04-17-04063(July2020);A-02-18-01006(August2020);
A-09-19-02005(June2021);A-04-17-03084(April2021);A-04-17-08058(March2021)
CMS should address inappropriate nursing home discharges through training, by
2.
implementing deferred initiatives, and by assessing the effectiveness of its
enforcement against inappropriate facility-initiated discharges.
Key OIG Findings
OIGidentifiedmultiplechallengesthatexistinidentifyingandaddressinginappropriatefacility-initiated
dischargesbynursinghomesandassessingtheirfrequency. CMSdoesnotcollectdataonthenumberof
facility-initiateddischargesfromnursinghomesandmanyStateombudsmendonotcountortrackthe
noticestheyreceive. Inaddition,ombudsmen,CMS,andStateagenciesmaydifferintheirperspectives
6 onregulationsandenforcementoffacility-initiateddischarges. FollowingCMSsinitiativetoreviewand
takeappropriateenforcementactionincasesofnoncompliancewithfacility-initiateddischarge
requirements,Stateagenciescitedmanymorenursinghomesfornotcomplyingwithnotice
requirementsfordischargesin2018. However,CMShasnotyetdeterminedthetrendsandoutcomesof
itsinitiative.
Progressin ImplementingtheRecommendation
InitsApril2022finalmanagementdecision,CMSstatedthatitplanstoprovidetraining,including
clarificationofguidancearoundfacility-initiateddischargesand/ortransfers. CMSwillalsoincorporatean
assessmentoftheeffectivenessofenforcementactionsinresponsetoinappropriatefacility-initiated
discharges. Lastly,CMSindicatedthatitisworkingtoimplementassoonaspossibleavarietyof
initiativesthatithadpreviouslydeferred.
RelevantReport:OEI-01-18-00250(November2021)
CMS should take steps to reduce the costs for Medicare and itsbeneficiaries by
3.
promoting the use of less costly, clinically appropriate drugs.
Key OIG Findings
Iftheleastcostlyalternativepolicies,whichbasethepaymentamountforagroupofclinically
comparableproductsonthatoftheleastcostlyone,hadnotbeenrescindedforPartBdrugsfromthe
thirdquarter2010andthesecondquarter2011,Medicareexpendituresforcertainprostatecancerdrugs
wouldhavebeenreducedby$33.3millionover1year(from$264.6millionto$231.3million). Afterleast
costlyalternativepolicieswereremoved,utilizationpatternsshifteddramaticallyinfavorofcertain
costlierproducts.
BiosimilarsalsohavethepotentialtosignificantlyreducecostsforPartDandbeneficiariesiftheiruse
becomesmorewidespread. WeestimatedthatannualPartDspendingonbiologicswithavailable
biosimilarscouldhavedecreasedby$84million,or18percent,in2019ifallbiosimilarshadbeenusedas
frequentlyasthemostusedbiosimilars. Additionally,beneficiariesout-of-pocketcostsforthesedrugs
couldhavedecreasedby$1.8million,or12percent. Fargreaterspendingreductionswillbepossibleas
additionalbiosimilarsbecomeavailable,particularlywiththeexpectedlaunchesofbiosimilarsforthe
blockbusterdrugHumirain2023.
Progressin ImplementingtheRecommendation
CMSdidnotconcurwiththerecommendationinour2012reporttoseekauthoritytoimplementleast
costlyalternativepoliciesinappropriatecircumstancesinPartB,andhassinceindicatedthatitdoesnot
plantotakeactionatthistime.
CMSconcurredwithOIGsrecommendationtoencouragePartDplanstoincreaseaccesstoanduseof
biosimilars,suchasthroughademonstrationprojectortheStarRatingssystem. CMSneitherconcurred
nornonconcurredwithourrecommendationtomonitorPartDplanssubmittedformulariesto
determinewhethertheydiscouragebeneficiariesfromusingbiosimilars. Initsfinalmanagement
decision,CMSstateditwillexaminehowdemonstrationprojectscouldbeusedtotestmethodstolower
7 beneficiaryandprogramspendingondrugsandincentivizetheuseofbiosimilars. Additionally,although
itdidnotconcurwiththesecondrecommendation,CMSreportedthataspartofitsannualreviewof
formulariesitwouldmonitorsubmittedformulariestodeterminewhethertheydiscouragebiosimilaruse.
RelevantReport:OEI-12-12-00210(November2012);OEI-05-20-00480(March2022)
CMS should improve and implement system edit processes for its DME Medicare
4.
contractors to prevent improper payments for services provided to hospice
beneficiaries.
Key OIG Findings
For121of200sampleddurablemedicalequipment,prosthetics,orthotics,andsupplies(DMEPOS)items,
MedicareimproperlypaidsuppliersforDMEPOSitemstheyprovidedtohospicebeneficiaries. These
itemswereprovidedtopalliateormanagethebeneficiaries'terminalillnessesandrelatedconditions
and,assuch,areconsideredincludedintheperdiempaymentsthatMedicarepaystohospices. These
itemsshouldhavebeenprovideddirectlybythehospicesorunderarrangementsbetweenthehospices
andthesuppliersandnotseparatelypaidbyMedicare.
Medicareimproperlypaidthesuppliersbecausethesystemeditprocessesthatshouldhaveprevented
theimproperpaymentswerenoteffectiveordidnotexist. Insomeofthesecases(67),thesuppliers
inappropriatelyusedamodifier(GW)toindicatethattheitemswerenotrelatedtothebeneficiaries
terminalillnessorconditions,butourauditfoundthattheseitemswererelated. Onthebasisofour
sampleresults,weestimatedthatMedicarecouldhavesaved$116.9millioninpaymentsduringour
auditperiodfromJanuary1,2015,throughApril30,2019,andbeneficiariescouldhavesaved
$29.8millionindeductiblesandcoinsurancethatmayhavebeenincorrectlycollectedfromthemorfrom
someoneontheirbehalf.
Progressin ImplementingtheRecommendation
CMSinstructedtheDMEMedicarecontractorstodenyDMEPOSclaimssubmittedbysupplierswithout
theGWmodifierforDMEPOSitemsprovidedtohospicebeneficiariesanddirecttheDMEandhospice
Medicarecontractors,orothercontractorsasappropriate,toconductprepaymentorpostpayment
reviewsofsupplierclaimsbilledwiththeGWmodifier. However,CMSdoesnotconcurwiththe
recommendationtoimplementapostpaymenteditprocess. CMSstatedthattheRecoveryAudit
ContractorswereapprovedtobeginreviewingDMEPOSclaimsbilledaftertheadmissiondateandbefore
thedischargedateofahospiceelectionbeginninginOctober2018. Webelievegiventhevolumeof
claimsthatwouldneedtobereviewedbytheRecoveryAuditContractors,implementinganautomatic
postpaymenteditprocesswouldleadtotimelyreviewofclaimsandrecoveryofimproperpayments. We
alsocontinuetorecommendthatCMSstudythefeasibilityofincludingpalliativeitemsandservicesnot
relatedtoabeneficiarysterminalillnessandrelatedconditionswithinthehospiceperdiem,a
recommendationwithwhichCMSdisagreed. ThereportfindingsandpriorOIGworkindicatesthatthere
ispotentialinappropriateunbundlingofitemsandservicesfromthehospicebenefit. Arequirementto
includepalliativeitemsandservicesnotrelatedtothebeneficiarysterminalillnessandrelatedconditions
8 withinthehospiceperdiemmaypromotebettercoordinationofcarebymakingthehospiceresponsible
fortheprovisionandcoordinationoftheseitemsandservices.
RelevantReport:A-09-20-03026(November2021)
9 SIGNIFICANTPROGRESS : Top25 RecommendationsFrom 2021 Edition
ToensurethatnursinghomesareimplementingactionstopreventthespreadofCOVID-19and
thattheyareprotectingresidents,CMSshouldassesstheresultsofinfectioncontrolsurveysof
nursinghomesandrevisethesurveyasappropriate. CMSshouldclarifyexpectationsforStates
tocompletebacklogsofstandardsurveysandhighprioritycomplaintsurveysthatwere
suspendedintheearlymonthsofthepandemic. Moreover,CMSshouldtakestepstobetter
ensurethatnursinghomesareadequatelystaffed. OEI-01-20-00430,OEI-04-18-00450,and
OEI-04-18-00451.
UPDATE:CMShastakenimportantstepstoimplementOIGrecommendationsrelatedtoimproving
infectioncontrolsurveysandleveragingnursinghomestaffingdatatobettertargetoversightand
increasetransparencyforconsumers. Withrespecttofocusedinfectioncontrolsurveys(FICSs),CMShas
assessedanddocumentedtheiradequacybymonitoringresultsofthesesurveysmonthly. CMS
concluded,basedonthismonitoring,thatFICSscontinuetohelpsurveyorsidentifynoncompliancewith
CMSspreventionandcontrolstandards,andCMShasincorporatedelementsfromthesurveysintothe
standardsurveyprocessusedtocertifyfacilitycompliance. Regardingnursinghomestaffingdata,in
January2022CMSbeganpostingweekendstaffingandstaffturnovermeasuresontheCareCompare
website. CMSalsosharesPayrollBasedJournalstaffingdata,includinglistsoffacilitiesthatpotentially
haveinsufficientweekendstaffing,withstatesurveyagencies. Lastly,CMSisintheprocessofgenerating
reportsandupdatingsurveydocuments,includingtheCriticalElementsPathways,whichareusedfor
investigatingareasofconcern. Thisprogressispartoflargernursinghomereformsthatthe
administrationandCMSarepursuing. OIGcontinuestoinvestsubstantiallyinoversightofnursinghome
qualityandsafetyandwillcontinuetomonitorCMSsprogressonrelatedreforms.
10 
CMS Medicare Parts A and B
In2021,approximately36millionbeneficiarieswereenrolledin
MedicarePartAand/orPartB. TotalexpendituresforMedicare
RelevantTMCs:
PartsAandBcameto$328.9billionand$405.5,respectively,with
 EnsuringtheFinancialIntegrity
PartAcostsleadingtoanetlossof$60.4billionfortheHospital
ofHHSPrograms
InsuranceTrustFund. The2022AnnualReportbyMedicaresBoardof
 DeliveringValue,Quality,and
TrusteesestimatesthattheTrustFundforMedicarePartA(hospital
ImprovedOutcomesinCMS
insurance)willbedepletedby2028. Italsoprojectsthatcostgrowth
Programs
forMedicarePartB(medicalinsurance)willaverage10.5percentover
thenext5years,significantlyoutpacingU.S.economicgrowth. To  Strengthening
CoordinationforBetter
ensurethatMedicareeffectivelyservesbeneficiarieswellintothe
future,HHSmustfostersoundfinancialstewardship,programintegrity, ProgramsandServices
andimprovedqualityofcareandhealthoutcomes. Thisincludes  SafeguardingtheWell-Beingof
helpingbeneficiaries,clinicians,andproviders;protectingMedicare HHSBeneficiaries
dollarsfromfraud,waste,andabuse;andimplementingprudent
paymentpolicies. OIGsworkpromotesqualityofcareforMedicarebeneficiariesinvarioussettings. Asa
toppriority,OIGisspecificallyfocusingonimprovingnursinghomes.
Top Unimplemented Recommendations
CMS should take the necessary steps to establish an IRF transfer payment policy
5.
for early discharges to home health care and reevaluate the IRF payment system,
which could include seeking legislative authority to make any changesnecessary to
more closely align IRF payment rates and costs.
Key OIG Findings
MedicarepaidIRFsnationwide$5.7billionin2013forcaretobeneficiariesthatwasnotreasonableand
necessary. TheseerrorsoccurredinpartduetoIRFpaymentsthatarenotalignedwithcosts,whichmay
haveprovidedIRFswithafinancialincentivetoadmitpatientsinappropriately.
Medicarecouldhavealsosavedapproximately$993millionin2017and2018ifCMShadexpandeditsIRF
transferpaymentpolicytoapplytoearlydischargestohomehealthcare. Thispaymentpolicywouldbe
consistentwiththetransferpaymentpoliciescurrentlyineffectforearlydischargesfromoneIRFto
anotherIRF,along-termcarehospital,aninpatienthospital,oranursinghome. Moreover,itwould
generallyprovideIRFswithpaymentsthataregreaterthantheircoststoprovidecare. However,CMS did
notexplainwhyithasnotexpandedtheIRFtransferpaymentpolicytocoverdischargestohomehealth
care.
11 Progressin ImplementingtheRecommendation
CMSindicatedthatithastakenseveralstepstoensurethatIRFpaymentsandcostsalignascloselyas
possible. InAugust2020,CMSpublishedafinalrulethatupdatedtheIRFcase-mixgroupsandthe
underlyingdatatobetteralignIRFpaymentswithpatientscareneeds. CMSindicatedthatitis
continuingtomonitorthechangestotheIRFclassificationsystem,alongwiththeeffectsoftheCOVID-19
pandemic,todeterminewhatimpactthesehavehadontherelationshipbetweenIRFpaymentsand
costs. Furthermore,CMSstatedthatitisworkingonanIRFReviewChoiceDemonstrationtoensurethat
patientsadmittedtoIRFsappropriatelymeettheMedicarecriteriaforIRFadmission. Inaddition,CMS
collaboratedwiththeHHSAssistantSecretaryforPlanningandEvaluationtodevelopaprototypeand
recommendationsforaunifiedpost-acutecarepaymentsystemthatincludesIRFs,skillednursing
facilities,homehealthagencies,andlong-termcarehospitals. CMSindicatedthattheprototypealigns
Medicarepost-acutecarepaymentsascloselyaspossiblewiththepost-acutecareneedsofallMedicare
beneficiariesandbreaksdownthesilosamongpost-acutecaresettingsthatcurrentlyincentivizepost-
acutecaresettingstoseekoutcertaintypesofpost-acutecarepatientsoverothers. Thereport
containingtheprototypewasdeliveredtoCongressonJuly1,2022,aspertherequirementsof the
IMPACTActof2014.
CMSincludedarequestforinformationfromthepublicintheFY2023IRFPPSproposedruleaboutthe
recommendationtoestablishanIRFtransferpaymentpolicyforearlydischargestohomehealthcare.
Wearereviewingtheinformationwereceivedduringthecommentperiodfortheruleandwillusethis
information,aswellasotherdataanalysis,toinformfuturepolicyinthisarea.
RelevantReports:A-01-15-00500(September2018);A-01-20-00501(December2021)
CMS should seek legislative authority to comprehensively reform the hospital
6.
wage index system.
Key OIG Findings
OIGidentifiedsignificantvulnerabilitiesinthewageindexsystemforMedicarepayments. Forinstance,
CMSlacksauthoritytopenalizehospitalsthatsubmitinaccurateorincompletewagedata,andMedicare
administrativecontractor(MAC)limitedreviewsdonotalwaysidentifyinaccuratewagedata.
Additionally,wageindexesmaynotalwaysaccuratelyreflectlocallaborprices. Thus,Medicarepayments
tohospitalsandotherprovidersmaynotbeappropriatelyadjustedtoreflectlocallaborprices.
Progressin ImplementingtheRecommendation
Initsfinalmanagementdecisionregardingtworelatednonlegislativerecommendations,CMSconcurred
withourrecommendationthatitworkwithMACstodevelopaprogramofin-depthwagedataauditsata
limitednumberofhospitalseachyear,focusingonhospitalswithwagedatathathighlyinfluencewage
indexesintheirrespectiveareas. CMSstatedthatitcontinuouslyevaluatesthewagedataauditprocess
andistakingtherecommendationintoaccountwhendeterminingappropriatenextsteps. CMS
nonconcurredwithourrecommendationthatitrescinditsownhold-harmlesspolicytousethewagedata
ofareclassifiedhospitaltocalculatethewageindexofitsoriginalgeographicarea. CMSstatedthatit
12 believesthatusingdatafromthemosthospitalstocalculateaveragewagesforanareaprovidesthemost
accurateandstablemeasure.
InCMSsfinalmanagementdecisionregardingourlegislativerecommendations,CMSconcurredand
indicatedthatthePresidentsBudgetforFiscalYear2021includedaproposalforthecreationofa
statutorydemonstrationtotestcomprehensivewageindexreform. However,Congresshasnotpassed
legislationauthorizingthedemonstrationrequest. Theproposeddemonstrationwasintendedto
redefinethelabormarketareatocommutingdatabyZIPCode,identifyanalternativesourceforwage
data,repealtheruralfloorandotherreclassificationsandspecialpaymentadjustments,andprovidecivil
monetarypenaltyauthoritytopenalizehospitalsthatsubmitinaccurateorincompletedata. However,
thisproposalwasnotincludedintheFY2023PresidentsBudget.
RelevantReport:A-01-17-00500(November2018)
CMS should recover overpaymentsof $1billion resulting from incorrectly assigning
7.
severe malnutrition diagnosis codes to inpatient hospital claims, ensure that
hospitals bill appropriately moving forward, and conduct targeted reviews of
claims at the highest severity level that are vulnerable to upcoding.
Key OIG Findings
HospitalsincorrectlybilledMedicareforseveremalnutritiondiagnosiscodesfor173ofthe200claims
thatwereviewed. Hospitalsusedseveremalnutritiondiagnosiscodeswhentheyshouldhaveusedcodes
forotherformsofmalnutritionornomalnutritiondiagnosiscodeatall,resultinginnetoverpaymentsof
$914,128fortheclaimsinoursample. Onthebasisofoursampleresults,weestimatedthathospitals
receivedoverpaymentsof$1billionforincorrectseveremalnutritiondiagnosiscodesforFYs2016and
2017.
Moregenerally,wealsofoundthathospitalsareincreasinglybillingforinpatientstaysatthehighest
severitylevel,whichisthemostexpensive. Thenumberofstaysatthehighestseveritylevelincreased
almost20percentfromFY2014throughFY2019,ultimatelyaccountingfornearlyhalfofallMedicare
spendingoninpatienthospitalstays. Thenumberofstaysbilledateachoftheotherseveritylevels
decreased. Staysatthehighestseveritylevelarevulnerabletoinappropriatebillingpracticessuchas
upcodingthepracticeofbillingatalevelthatishigherthanwarranted. Manyofthesestaysatthe
highestseveritylevelhadotherpatternsthatraisequestions,suchasparticularlyshortdurationsand
havingonlyonediagnosisthatelevatedthestaytothathighestseveritylevel. Furthermore,hospitals
variedsignificantlyinbillingthesestays,withsomebillingmuchdifferentlythanmost.
Progressin ImplementingtheRecommendation
CMShastakeninitialstepstowardimplementingtherecommendationsrelatedtoseveremalnutrition
diagnosiscodes. Specifically,CMStaskeditsSupplementalMedicalReviewContractor(SMRC)with
researchandanalysistodevelopamedicalreviewstrategyformalnutritionclaims. TheSMRC
determinedprovidersuseoftheseveremalnutritiondiagnosiscodes(E41andE43)continuedtotrend
13 upwardandmadeseveralrecommendationstoCMS,includingdevelopmentandcreationofpolicy
regardingmalnutritiondiagnosticcriteriaintheformoflocalcoveragedeterminationstoprovide
consistentguidancefromtheMACs. Withrespecttothenetoverpaymentamountidentifiedforthe
claimsinoursample,CMShassofarrecovered$400,208ofthe$505,400thatwaswithinthe4-year
reopeningperiod. CMSalsotaskedtheSMRCwithpostpaymentreviewofclaimswithE41andE43from
calendaryear(CY)2019;thisprojectisinprogress. TheSMRCiscurrentlyconductingdiscussions,
education,andre-reviews. Duringthisprocess,providerscansubmitmissingand/oradditional
documentation,havetheirclaimsre-reviewed,andreceiveeducation.
InresponsetoourrecommendationthatCMSconducttargetedreviewsofMedicareSeverityDiagnosis
RelatedGroupsandstaysthatarevulnerabletoupcoding,aswellasthehospitalsthatfrequentlybill
them,CMSdidnotconcurbutacknowledgedthatthereismoreworktobedonetodetermine
conclusivelywhichchangesinbillingareattributabletoupcoding. Furtheroversightandrecoveryaudit
contractorreviews,whicharealreadybeingconducted,areessentialtoensuringthatMedicaredollars
arespentappropriately.
RelevantReports:A-03-17-00010(July2020);OEI-02-18-00380(February2021)
14 
CMS Medicare Parts C and D
Approximately52.9millionbeneficiariesreceivedMedicarePartD
RelevantTMCs:
benefitsand28.9millionbeneficiarieswereenrolledinMedicare
PartCin2022. PartDisaprescriptiondrugbenefitprovidedthrough  EnsuringtheFinancialIntegrity
privateinsurancecompaniesknownasPartDplansponsors. PartC ofHHSPrograms
(MedicareAdvantage)enrolleesreceivetheircoveragethroughprivate  DeliveringValue,Quality,and
insurancecompaniesthatcontractwithCMS. OIGsbodyofworkhas ImprovedOutcomesinCMS
identifiedchallengesinensuringprogramintegrityintheMedicare Programs
AdvantageandPartDprograms. Asatoppriority,OIGisspecifically  SafeguardingtheWell-Beingof
focusingoncurbingtheopioidepidemicthroughenforcement HHSBeneficiaries
mechanismsandidentifyinginappropriateprescribersand  HarnessingandProtectingData
beneficiariesatriskofabuseoroverdoseintheMedicareAdvantage andTechnologyToImprovethe
andPartDprograms. HealthandWell-Beingof
Individuals
Top Unimplemented Recommendations
CMSshould take steps to increase accessto treatments foropioid use disorder.
8.
Key OIG Findings
BasedonMedicarePartsB,C,andDclaims,justover1millionMedicarebeneficiarieshadadiagnosisof
opioidusedisorderin2020. Althoughthischronicdiseasecanbetreatedwithmedication,lessthan
16percentofthesebeneficiariesreceivedmedicationtotreattheiropioidusedisorderin2020.
Evenfewerbeneficiariesreceivedbothmedicationandbehavioraltherapyfortreatment. Lessthanhalf
ofthebeneficiarieswhoreceivedmedicationtotreattheiropioidusedisorderalsoreceivedbehavioral
therapy. Mostbeneficiariesreceivedmedicationinanoffice-basedsetting,asopposedtoanopioid
treatmentprogram,andofthosebeneficiarieslessthanone-thirdofthebeneficiariesreceivedbehavioral
therapy.
Furthermore,Asian/PacificIslander,Hispanic,andBlackbeneficiarieswerelesslikelytoreceive
medicationtotreattheiropioidusedisorderthanWhitebeneficiaries,raisinghealthequityconcerns.
OlderbeneficiariesandthosenotreceivingPartDlow-incomesubsidieswerealsolesslikelytoreceive
medicationtotreattheiropioidusedisorder.
Progressin ImplementingtheRecommendation
CMShastakenseveralstepstoeducatebeneficiariesaboutaccesstomedicationsforthetreatmentof
opioidusedisorderandnaloxone. InJune2021,CMSreleasedtheCMSActionPlantoEnhance
PreventionandTreatmentofOpioidUseDisorder,whichoutlinesplanstoaddressmanyofOIGsfindings.
CMSconfirmedthatitisworkingonconductingadditionaloutreachtobeneficiariestoincrease
awarenessaboutcoverageforthetreatmentofopioidusedisorder;takingstepstoincreasethenumber
15 ofproviderandopioidtreatmentprogramsforMedicarebeneficiarieswithopioidusedisorder;taking
stepstoaddressdisparitiesinthetreatmentofopioidusedisorder;collectingdataontheuseof
telehealthinopioidtreatmentprograms;increasingtheutilizationamongbeneficiariesreceiving
medicationtotreatopioidusedisorder;andcontinuingtoupdateitsexistingMedicareprintandweb
content.
CMShasnotyetexplicitlyindicatedwhetheritwillassisttheSubstanceAbuseandMentalHealthServices
Administration(SAMHSA)byprovidingdataaboutthenumberofMedicarebeneficiariesreceiving
buprenorphineinoffice-basedsettingsorthegeographicareaswhereMedicarebeneficiariesremain
underserved.
RelevantReport:OEI-02-20-00390(December2021)
CMS should monitor and provide targeted oversight for MAOs that had a
9.
disproportionate share of risk-adjusted payments from chartreviews and HRAs.
Key OIG Findings
TheMAprogrammakesrisk-adjustedpaymentstoMAOstoaccountforhealthstatusdifferencesamong
enrolledbeneficiariesinordertodetermineamonthlypayment. MAOsarepaidhigherpaymentsfor
beneficiarieswhoneedacostlierlevelofcare(basedondiagnosessubmittedbyMAOs),whichhelpsto
ensurethesebeneficiarieshavecontinuedaccesstoMAplans. Chartreviewsareretrospectivereviewsof
beneficiarymedicalrecordstoidentifyandadddiagnosesthatprovidersdidnotoriginallysubmitto
MAOsanddeleteanyinvaliddiagnoses. Chartreviewsareintendedtoensureaccuraterisk-adjustment
payments. HRAscollectinformationonhealthstatus,healthrisks,anddailyactivitiesfrombeneficiaries.
Whenusedproperly,HRAscanimprovebeneficiariescarecoordinationandhealthoutcomes. However,
OIGhasidentifiedconcerningpatternsindiagnosesarisingfromchartreviewsandHRAs. Specifically,OIG
foundthat$2.7billioninrisk-adjustedpaymentsresultedfromchartreviewdiagnosesthatMAOsdidnot
linktospecificservicesprovidedtothebeneficiaries. OIGalsofounddiagnosesthatMAOsreportedonly
onHRAsandnootherencounterrecordsresultedinanestimated$2.6billioninrisk-adjustedpayments
in2017,within-homeHRAsgenerating80percentoftheseestimatedpayments. Thesefindingsraise
concernthatthesediagnosesonlyonchartreviewsorHRAsmaynotbeaccurateandthat,ifthese
diagnosesareaccurate,beneficiariesmaynotbereceivingallneededcareforoften-seriousconditions.
Twentyofthe162MAOsdroveadisproportionateshareofthepaymentsfromdiagnosesthatwere
reportedonlyonchartreviewsandHRAsandnootherservicerecordswithonecompanydriving
almost40percentofthesepaymentsyethavingenrolledonly22percentofMAbeneficiaries.
Progressin ImplementingtheRecommendation
CMSimplementedourrecommendationtoprovidetargetedoversightofMAOsthathadrisk-adjusted
paymentsfromunlinkedchartreviewsforbeneficiariesbyprovidingdataexchangereportsdirectlyto
MAOswithunlinkedchartreviews. CMSconcurredwithourrecommendationstoprovidetargeted
oversightofthe10MAOparentorganizationsthatdrovemostoftherisk-adjustedpaymentsresulting
fromin-homeHRAs,andtoprovidetargetedoversightofthe20MAOsthatdroverisk-adjustedpayments
16 resultingfromin-homeHRAsforbeneficiarieswithnootherservicerecordsinthe2016encounterdata.
CMSintendstoprovidedocumentationoftheirincreasedoversighteffortspertainingtoHRAsin
November2022. CMSnonconcurredwithourrecommendationstoprovideoversightofthe20MAO
companiesthathadadisproportionateshareoftherisk-adjustedpaymentsfromchartreviewsandHRAs,
statingthatHRAsandchartreviewsareallowablesourcesofdiagnosesforrisk-adjustedpaymentsinthe
MAOprogram.
RelevantReports: OEI-03-17-00470(December2019);OEI-03-17-00471(September2020);
OEI-03-17-00474(September2021)
CMS should require MAOs to submit and encourage MAOs to provide program
10.
oversight based on an ordering providers NPI on encounter records for DME,
prosthetics, orthotics, and supplies, as wellas for laboratory, imaging, and home
health services.
Key OIG Findings
Orderingandreferringprovideridentifiersarenotrequiredin,andwerefrequentlyabsentfrom,
MedicareAdvantageencounterdataforrecordsofDME,prosthetics,orthotics,andsupplies,clinical
laboratory,imaging,andhomehealthservices. Thelackoforderingandreferringprovideridentifiers
limitstheuseofthesedataforvitalprogramoversightandenforcementactivities. Forexample,these
provideridentifiersarecriticalforidentifyingquestionablebillingpatternsandpursuingfraud
investigationsfororderingandreferringproviders. InanOIGsurveyconductedin2020,almosthalfof
theMAOsthatlackedorderingNPIsonatleastsomeMAencounterrecordsraisedconcernsthatthis
hinderedtheirdataanalysisforprogramintegrity. AnNPIisanimportanttoolforassessingwhether
orderingorreferringprovidershavedeterminedthatserviceswereappropriateforpatients.
Progressin ImplementingtheRecommendation
InitsJanuary2022 update,CMSstatedthattheMedicareprogramwillneedtoundertakerulemakingto
implementthisrequirementandthatCMSwasunabletoprovidedetailsoratimelinefortaking
rulemakingactionatthattime.
RelevantReports:OEI-03-15-00060(January2018);OEI-03-19-00430(August2020);
OEI-03-19-00432(April2021)
17 CMS should develop and execute a strategy to ensure that Part D does not pay for
11. drugs that should be covered by the Part A hospice benefit.
Key OIG Findings
MedicarePartDpaidfordrugsduring2016thatshouldhavebeencoveredbythedailyratespaidto
hospicesunderthePartAhospicebenefit. Hospicesarerequiredtoprovidethebeneficiarysdrugsthat
areusedprimarilyforthereliefofpainandsymptomcontrolrelatedtotheterminalillness. IfPartDpays
forthem,Medicareisineffectpayingtwice. TheestimatedPartDtotalcostwas$160.8millionforthe
sampleofdrugsthathospiceorganizationsshouldhavecoveredin2016. Hospiceslikelyshouldhavealso
coveredmanyoftheotherdrugsprovidedtobeneficiariesinhospicecareforwhichPartDpaidan
additional$261.9millionthatsameyear.
Progressin ImplementingtheRecommendation
AlthoughCMSagreedwiththeimportanceofavoidingduplicatepaymentstoMedicarePartDdrugplan
sponsorsandhospices,CMSneitherconcurrednornonconcurredwithourrecommendation. However,
initscommentsCMSstatedthatitsthen-currenteffortswouldaddressthisissueandensurethatno
disruptionoccursinbeneficiaryaccess. Forinstance,CMSstatedthatitwouldcontinuetoengagein
meaningfulactivitiestoreduceduplicatepaymentinthisareaby,forexample,ensuringthathospice
providersareproactivelyeducatingbeneficiariesoncoveredservicesanditems(includingdrugs),and
thatPartDdrugplansponsorsareappropriatelyapplyingpriorauthorizationcriteriaandcoordinating
withhospiceprovidersondrugcoverageissues. InafinalmanagementdecisionreceivedinOctober
2021,CMSdidnotindicatethatithadanyplannedactionstoworkdirectlywithhospicestoensurethat
theyareprovidingdrugscoveredunderthehospicebenefit,aswehaverecommended.
RelevantReports:A-06-17-08004(August2019);OEI-02-16-00570(July2018);OEI-02-10-00491
(March2016)
18 IMPLEMENTED:Top25 RecommendationFrom 2021 Edition
Withrespecttobeneficiariesreceivingtreatmentforopioidusedisorder,CMSshouldeducate
PartDbeneficiariesaboutaccesstomedicationassisteddrugsandnaloxone. OEI-02-19-00130
Update:Ina2020CallLetter,CMSpublishedinformationaboutthecoverageofbothMATdrugsand
naloxoneaswellastheco-prescribingofnaloxone. Inthe2021DearDoctorLetter,CMSincluded
languageaboutco-prescribingnaloxone,thecoverageofnaloxoneandMATavailableunderMedicare,
andinformationaboutMedicarePartDopioidpolicies. CMSalsohaslanguageinits2022Medicare&
YouhandbookaboutMedicarecoverageoftreatmentforopioidusedisorderandnaloxone. Inaddition,
under42C.F.R.423.128(b)(11)allPartDsponsorsarerequiredtoeducatetheirenrolleesaboutopioid
risksandalternativesasofJanuary1,2022. Finally,CMSalsoprovidedOIGwithacopyofCMS
Publication12033,SaferUseofOpioidPainMedication,todemonstrateitseffortstoeducate
beneficiariesaboutaccesstonaloxoneandMATdrugs. Thispublicationincludesinformationabout
naloxoneandencouragesbeneficiariestotalktotheirdoctorsaboutopioidalternatives.
19 
CMS Medicaid
MedicaidservesmoreenrolleesthananyotherFederalhealthcare
program,andMedicaidspendingrepresentsone-sixthofthenational
RelevantTMCs:
healthcareeconomy. In2020,Medicaidspendinggrew9.2percentto
 EnsuringtheFinancialIntegrity
$671.2billion. AsofMarch2022,Medicaidservednearly88million
ofHHSPrograms
individuals,includingthoseinCHIP. OIGsworkhasidentified
 DeliveringValue,Quality,and
substantialimproperpaymentstoprovidersacrossavarietyof
ImprovedOutcomesinCMS
Medicaidservicesandonbehalfofineligibleindividuals. OIGhasalso
Programs
identifiedconcernswiththecompletenessandreliabilityofnational  SafeguardingtheWell-Beingof
Medicaiddata. Medicaidhasexperiencedlongstandingprogram HHSBeneficiaries
integrityvulnerabilitiesandchallengesinensuringthatbeneficiaries  HarnessingandProtectingData
haveaccesstoandreceivehigh-qualitycare. andTechnologyToImprovethe
HealthandWell-Beingof
Individuals
Top Unimplemented Recommendations
CMS should ensure that States reporting of nationalMedicaid data is complete,
12.
accurate, and timely.
Key OIG Findings
EffectiveoversightofMedicaidrequiresanationalsystemwithcompleteandaccuratedata. However,
nationalMedicaiddataknownastheTransformedMedicaidStatisticalInformationSystem(T-MSIS)
havedeficienciesthathindertimelyandaccuratedetectionofpotentialfraud,waste,poorqualitycare,
and/orinsufficientaccesstocare. OIGhasrepeatedlyfoundthatStatesdidnotalwayssubmitcomplete
Medicaiddataneededforoversight. Forexample,inonereviewOIGfoundStatesdidnotsubmit
completedataonprovideridentifiersanddiagnosiscodesforopioidprescriptions,hinderingtheabilityto
monitorandaddresstheopioidcrisisinMedicaid. Inanotherreview,OIGfoundthatmostStatesdidnot
providecompleteoraccuratepaymentdataonmanagedcarepaymentstoproviders.
Progressin Implementingthe Recommendation
CMShasmadeimprovingdataqualityinT-MSISapriority. CMSindicatedthatitreviewsT-MSISdata
submissionsaspartoftheT-MSISStatecomplianceprocess,andthatCMSalsosentallStateMedicaid
directorsacomplianceletterindicatingenhancedsystemsfundingisatriskforeachStatethatdoesnot
addressitsrespective,remainingprioritydataqualityissues. CMSdevelopednewdataelementsthatcan
beusedtouniquelyreportmultipleidentifiersassociatedwithasinglebeneficiary. Finally,CMSindicated
thatitwillworkwithaStatetorectifyincomplete,inaccurate,oruntimelyencounterdatasubmissions
whendeficienciesarefoundinT-MSISdatasubmissions. Theseactionshaveledtosomeimportant
improvements,butmoreneedstobedoneasT-MSISdatadeficienciespersist. Forexample,CMScan
strengthenitseffortstoimprovetheaccuracyandcompletenessofmanagedcarepaymentdatain
20 T-MSIS. AsMedicaidenrollmenthasincreasedandutilizationhaschanged,itiscriticalthatthe
DepartmentisabletotrackMedicaidpaymentsforservicesandmonitorutilizationtoensurethat
enrolleesarereceivingnecessarycare. Also,thesedatacanbeusedtodetectpotentialfraudschemes
andinformpublichealthefforts.
RelevantReports:OEI-05-18-00480(August2019);OEI-02-15-00260(July2018);OEI-03-19-00070
(March2020);OEI-02-19-00180(March2021)
CMS should monitor national performance data for blood lead screening tests for
13.
children and target efforts toward low-performing States to develop action plans
for increasing the provision of blood lead screening tests.
Key OIG Findings
Thereisnosafelevelofleadexposure;evenlow-levelbloodleadconcentrationsduringchildhoodhave
beenassociatedwithbehavioralandphysicalimpairments. Childrenexposedtoleadmaysufferstunted
cognitivedevelopmentanddelayedreproductivedevelopment. MedicaidsEarlyandPeriodicScreening,
Diagnostic,andTreatment(EPSDT)benefitcoverspreventivemedicalservicesincludingbloodlead
screeningtestsforenrolledchildren. Inthe5Stateswereviewed,38percentof1million
Medicaid-enrolledchildrendidnotreceiveabloodleadscreeningtestat12monthsor24monthsofage,
asrequiredbyMedicaidsscheduleduringFYs201518.
Progressin ImplementingtheRecommendation
CMSconcurredwiththerecommendationandstatedthatitwouldmonitornationalEPSDTperformance
dataforbloodleadscreeningtestsforchildreninordertoidentifyStatesperforminginthelowest
quartile. CMSwillrequestthatStatesperforminginthelowestquartiledevelopanactionplan,andCMS
willprovidetechnicalassistance,asnecessary.
RelevantReport:OEI-07-18-00371(October2021)
CMS should develop policies and procedures to improve the timeliness of
14.
recovering Medicaidoverpaymentsand recoveruncollected amountsidentified by
OIGs audits.
Key OIG Findings
CMShadnotrecoveredalloverpaymentsidentifiedinOIGauditreportsinaccordancewithFederal
requirements. AsofMay2018,CMShadrecoveredabout$909.2millionofthe$2.7billioninMedicaid
overpaymentsidentifiedinthecurrent(FYs201015)andprior(FYs200409)periods. However,CMS
didnotcollecttheremaining$1.8billionfor84OIGauditreports. Specifically,CMShadnotcollected
about$1.6billioninoverpaymentsidentifiedin77currentperiodauditsand$188.6millionin
overpaymentsidentifiedin7priorperiodaudits.
21 Progressin ImplementingtheRecommendation
AsofApril2022,CMShadcollected$381.9millionfrom19ofthe84reports. However,CMShadstillnot
collectedabout$1.5billioninoverpaymentsidentifiedin73ofthe84auditreports. Specificdetailsof
CMSsprogresstowardthesecollections,asreportedbyCMS,areasfollows. InOctober2018,CMS
indicatedthatithadissuedorwasintheprocessofissuingdisallowanceletterstotaling$383.5millionfor
10audits. CMShasbeenworkingtoresolvecomplexpolicyquestionsrelatedto27auditswith
$948.6millioninOIG-identifiedoverpaymentsandhasissueddemandlettersfor$142.8millionrelatedto
theseaudits. CMShasissuedorisintheprocessofissuingeitherauditcompromiselettersor
disallowanceletterstotaling$143.5millionfor14audits. CMSisstillreviewing33auditstotaling
$357millioninOIG-identifiedoverpayments. CMSisalsoexploringoptionsforimprovingthetimeliness
ofdiscussionswithStateofficials,obtainingdocumentationfromStates,andissuingdisallowanceletters.
Additionally,CMScontinuestoexploreoptionsforimprovingthetimelinessofrecoveringidentified
overpayments. Forinstance,itrecentlyrealignedthefinancialmanagementstaffinitsFinancial
ManagementGroupandupdatedstandardoperatingproceduresandtechnicalguidelinesthatitbelieves
willmakeitsprocessesmoreefficienttoallowformoretimelyresolutionsofidentifiedoverpayments.
Underthisrealignment,CMScreatedanAuditandReviewBranchforauditresolutions,aswellasa
DevelopmentandOversightBranch,toensurethatMedicaidandCHIPfinancialpolicyisapplied
consistentlyonanationalbasis. Inaddition,theFinancialManagementGroupiscurrentlydevelopinga
MedicaidandCHIPFinancialSystemtooverseeandmanageMedicaidandCHIPfinancialreporting;this
systemwillreplacetheMedicaidBudgetandExpenditureSystem.
RelevantReport:A-05-17-00013(December2018)
CMS should improveMedicaid MCOs identifications and referrals of cases of
15.
suspected fraud or abuse.
Key OIG Findings
MCOshaveanimportantroleinfightingfraudandabuseinMedicaid,yetweaknessesexistintheir
effortstoidentifyandaddressfraudandabuse. Althoughthenumberofcasesvariedwidely,wefound
thatsomeMCOsidentifiedandreferredfewcasesofsuspectedfraudorabusetoaState,andnotall
MCOsusedproactivedataanalysisacriticaltoolforfraudidentification,basedonanalysisofdata
collectedin2015. Inaddition,MCOstookactionsagainstproviderssuspectedoffraudorabusebutdid
nottypicallyinformaState. Forexample,MCOsthatterminatedprovidercontractsforreasons
associatedwithfraudorabusedidnottypicallyinformaState. Finally,MCOsdidnotalwaysidentifyand
recoveroverpayments,includingthoseassociatedwithfraudorabuse. Instead,overpaymentswere
factoredintofutureMCOpaymentsfromtheState. TheseweaknessesmaylimittheStatesabilitiesto
effectivelyaddressfraudandabuseintheirMedicaidprograms.
Progressin ImplementingtheRecommendation
CMSconcurredwiththerecommendationandindicatedthatitcontinuestoworkwithStatestoprovide
technicalassistanceandeducationtoidentifyfraudandabuseandsharebestpracticestoassistStatesin
22 improvingMCOidentificationandreferringcasesofsuspectedfraudorabuse. CMSalsoindicatedithas
planstoofferaMedicaidManagedCarecourseattheMedicaidIntegrityInstituteforStateMedicaid
staff.
RelevantReport:OEI-02-15-00260(July2018)
CMS should identify States with limited availability of behavioral health services
16.
and develop strategies and share information to ensure that Medicaid managed
care enrollees have timely access to these services.
Key OIG Findings
OIGfoundthattheStateofNewMexicosMedicaidmanagedcareprogramoperatedwithalimited
availabilityofbehavioralhealthservicesforitsenrollees,includingfewbehavioralhealthprovidersand
difficultyarrangingservices. Ina2019report,NewMexicosBehavioralHealthOrganizationsreported
challengeswithfindingandretainingstaff,basedonananalysisof2017managedcaredata. Theyalso
reportedchallengeswithcontinuityofcareforenrollees,citinglimitedcarecoordination,provider
shortages,andbarrierstosharinghealthinformation. ThechallengesfacedbyNewMexicoarelikely
sharedbyotherStatesandwillrequirebothStateandnationalattention. Telehealthisakeytoolthat
NewMexicoandmanyotherStatesusetotrytoensurethatMedicaidmanagedcareenrolleeshave
sufficientaccesstobehavioralhealthservices. Ina2021report,OIGfoundthatmostStatesreported
multiplechallengeswithusingtelehealthtoprovidetheseservices,includingalackoftrainingfor
providersandenrollees,limitedinternetconnectivityforprovidersandenrollees,difficultieswith
providersprotectingtheprivacyandsecurityofenrolleespersonalinformation,andthecostof
telehealthinfrastructureandinteroperabilityissuesforproviders. Thesefindingswerebasedasurveyof
StateMedicaidDirectorsin2020. CMSplaysanimportantroleinfacilitatingtheexchangeofinformation
aboutapproachestoaddressingStateseffortstoensureaccesstobehavioralhealthservices. Sharing
thisinformationamongStateswillhelpStatesaddressconcernsaboutshortagesofbehavioralhealth
providersandrealizethepotentialbenefitsoftelehealth.
Progressin ImplementingtheRecommendation
CMSconcurredwithourrecommendationtoidentifyStatesthathavelimitedavailabilityofbehavioral
healthservicesanddevelopstrategiesandshareinformationtoensurethatMedicaidmanagedcare
enrolleeshavetimelyaccesstotheseservices. CMSconsultedwithStatesandotherstakeholdersonthe
developmentofatemplateforStatestoattesttotheirplanscompliancewithmanagedcare
requirements. CMSintendedthatStatesreportingrequirementswouldbecollectedelectronically
throughaweb-basedsubmissionportal. Moreover,CMSindicatedthatitsAnnualManagedCare
ProgramReportstandardizedtemplatecontainsacategoryforavailability,accessibility,andnetwork
adequacystandards,aswellasgrievancesrelatedtoaccess. Afterreviewingtheinformationsubmitted
byStatesinthesereports,CMScanassesswhetheradditionalstandardsareneeded.
CMSalsoconcurredwiththerecommendationtoshareinformationtohelpStatesaddresschallenges
withusingtelehealthtoprovidebehavioralhealthservicestoMedicaidenrollees. CMSnotedthatitwill
23 takeintoaccountthebroaderconcernsOIGidentifiedwithusingtelehealthindetermininghowitcan
furthersupportStateswithusingtelehealthtoensuretheprovisionofhigh-qualitybehavioralhealth
servicestoMedicaidenrollees.TheBipartisanSaferCommunitiesAct,passedinJune2022,alsodirects
theSecretarytoprovidetechnicalassistanceandissueguidancetoStatesonimprovingaccessto
telehealthservicescoveredunderMedicaidandCHIP.
RelevantReports:OEI-02-17-00490(September2019);OEI-02-19-00400(September2021);
OEI-02-19-00401(September2021)
24 Administration for Children and Families (ACF)
ACFprogramsfocusonpromotingtheeconomicandsocialwell-being
RelevantTMCs:
offamilies,children,individuals,andcommunities. OIGsworkfocuses
onensuringprogramintegrity,qualityofcare,andsafetyinACFs  SafeguardingtheWell-Beingof
grantsprogramsthatprovidecriticalhealthandhumanservicesto HHSBeneficiaries
children,families,andcommunities. ThisincludesACFsOfficeof  Strengthening
RefugeeResettlement(ORR)program,whichisresponsibleforthe CoordinationforBetter
careandwell-beingofunaccompaniedmigrantchildreninHHS ProgramsandServices
custodypriortobeingreleasedtosponsorsintheUnitedStates.
Top Unimplemented Recommendations
ACF should improve access to appropriate mental health treatment services for
17.
unaccompanied children and take all reasonable steps to minimize the amount of
time that they remain in ORRs custody.
Key OIG Findings
InaSeptember2019report,OIGfoundthatORRfacilitiesfacedchallengesinaddressingthemental
healthneedsofunaccompaniedchildren(UC),especiallythosewhohadexperiencedsignificanttrauma,
giventheuncertaintyofhowlongachildwouldremaininORRcare. Facilitiesreportedchallengesin
areasthatincludedemployingmentalhealthclinicians,ashortageofwhichresultedinhighcaseloadsand
limitedtheireffectivenessinaddressingchildren'sneeds;accessingexternalmentalhealthcare
providers;andtransferringchildrentofacilitieswithinORR'snetworkthatprovidespecializedtreatment.
Progressin ImplementingtheRecommendation
ORRhastakenstepstoimproveaccesstomentalhealthtreatmentservicesforUC. ACFindicatedthatit
establishedtheORRTraumaTrainingInitiativeinSeptember2021tobuildpartnershipsandassistORR
programs,includingORRprogramsstaffandgrantees,inimprovingtrauma-informedknowledgeand
competencies. Inaddition,ACFdevelopedaworkgrouptodiscussstrategiesforenhancingthe
recruitmentofclinicians. ORRalsomadeprogressinincreasingtherapeuticplacementoptionsfor
childrenwhorequiremoreintensivementalhealthtreatment. AsofJanuary2021,ACFhasfunded11
therapeuticprograms. TherearestillactionsACFcantaketoaddressthementalhealthneedsofUC,
includingfullyimplementingORRsadditionalplanstohireandretainqualifiedmentalhealthclinicians,
evaluatingmaximumcaseloadsforindividualmentalhealthneeds,andidentifyingstrategiesfor
connectingmentalhealthspecialiststocareproviderfacilities.
RelevantReport:OEI-09-18-00431(September2019)
25 ACF and HHS should improve theiroperational, management, and communication
18.
systems to better address the safety and security needs of unaccompanied
children.
Key OIG Findings
OIGidentifiedvulnerabilitiesinthesafetyincidentreportingsystemandoversightofcareprovider
facilitiesphysicalsecurity. InreportsreleasedinJune2020,wefoundthatORRsincidentreporting
systemisineffectiveatcapturinginformationaboutincidentsoccurringatproviderfacilitiesthatassists
ORRseffortstoensurethesafetyofminors. Moreover,wefoundthatORRsreportingsystemlacks
designatedfieldstocaptureinformationthatORRcanusetooverseefacilitiesandprotectminorsintheir
care. Wealsofoundthat,asidefromORRsmonitoringtoolsusedtoreviewphysicalsecuritymeasures
andvariationsinStateandlocallicensingrequirements,ORRreliesprimarilyonfacilitiestoself-identify
andcorrectconcernswiththephysicalsecuritymeasuresitrequires. Furthermore,wefoundalmostall
facilitiesinspectionchecklistsdidnotincludechecksofwhetherallORR-requiredphysicalsecurity
measureswerepresentandworking.
Inadditiontothesesafetyandwelfareissues,wefoundthatinteragencycommunicationfailuresand
poorinternalmanagementdecisionsleftHHSunpreparedforthezero-tolerancepolicy,underwhich
immigrationofficialsseparatedchildrenfromtheirparentsorlegalguardiansandreferredthemtoORR.
WhileHHSwasnotresponsibleforseparatingfamilies,thislackofinteragencypreparationand
coordinationimpededHHSsabilitytoidentify,carefor,andreunifychildrenwiththeirparentsor
guardians. Wealsofoundcareproviderfacilitiesfacedsignificantoperationalchallengesateverystageof
reunification,causingchildrentoexperienceadditionalstress.
Progressin ImplementingtheRecommendation
ACFandHHSagreedwithOIGsfindingsandhaveplannedstepstoimplementtherecommendations.
RegardingORRsincidentreportingsystem,ACFcontinuestostabilizeandgraduallyimprovethecurrent
UCPortalplatform. ORRsUCPortalteamhasmadeimprovementstotheportaloverthepastyearand
releasesbiweeklyupdates,rangingfromcasemanagementuserexperienceimprovementstoadding
featuresandfunctionsrequiredbyORRpolicy. TimelyupdatestotheUCPortalplatformareimportant
foroversightofORRsprogramandforprotectingchildreninORRscare.
Regardingphysicalsecuritymeasures,ACFupdateditsSiteVisitWorksheetandWalkthroughChecklistto
confirmthatfacilitiesinspectionchecklistsincludeallORR-requiredphysicalsecuritymeasures. ACFalso
finalizedguidancethatdescribesORRsplannedmethodstoensurethatfacilitiesregularlyreport
inspectionchecklistresultstoORR. ORRexaminedwhethertoenhanceexistingphysicalsecurity
requirementsforfacilities,andsucheffortsarecurrentlyunderway.
Withrespecttocommunicationandmanagementchallenges,ACFreportedinaDecember2021update
thatithadestablishedanonlinedirectoryoffieldguidanceissuedtocareproviderfacilitiesandengaged
invariouseffortstoimprovecoordinationwithinteragencypartners. Inaddition,ACFrecentlyindicated
thatORRhasdevelopedanemergencypolicydevelopmentprotocolthatprovidesinputfromstaffwith
expertiseinchildwelfarewheneverORRdevelopsandreevaluatesexistingpoliciesandfieldguidance.
26 HHSstillneedstotakespecificstepstoensurethatchildrensinterestsareprioritizedandrepresentedin
decisionsaffectingtheUCprogram,includingdirectingACFandORRleadershipto:(1)ensurethat
potentialriskstochildrenareexplicitlyassessedandconsideredindecisionsaboutpoliciesaffectingUC;
(2)ensurethatstaffarenotpreventedfromdocumentingconcernsaboutchildrenswell-being;and
(3)clearlycommunicatetoACFandORRleadershipandstaffthattheyareexpectedtoelevate
informationandrecommendationsnecessarytoprotectchildrensinterests. Finally,ACFnotedthatitis
takingastepwiseapproachtoupgradingtheUCPortalincoordinationwithDHSbyreducingmanual
processesusedtoidentifyandtrackseparatedchildren.
Relevant Reports:OEI-BL-18-00510(March2020);OEI-09-18-00430(June2020);OEI-05-19-00210
(June2020);OEI-07-21-00251(September2022)
ACF should develop acomprehensive strategy to improve States compliance with
19.
requirements related to treatment planning and medication monitoring for
children in foster care who are prescribed psychotropic medication.
Key OIG Findings
InthefiveStateswereviewedbetweenOctober1,2014,andMarch31,2015,oneinthreechildrenin
fostercaretreatedwithpsychotropicmedicationsdidnotreceiverequiredtreatmentplanningor
medicationmonitoring. StaterequirementsforpsychotropicmedicationoversightintheseStatesdidnot
alwaysincorporatesuggestedprofessionalpracticeguidelinesfortreatmentplanningandmedication
monitoring.
Progressin ImplementingtheRecommendation
Initsfinalmanagementdecision,ACFindicatedthatthetopicofoversightofpsychotropicmedications
wouldbeaddressedwithitsconstituencygroupofStatefostercaremanagers. Initslatestupdatein
September2021,ACFstatedthatitassessedthefindingsfromthethirdroundofitsStateChildand
FamilyServicesReviewsrelatedtotheuseofpsychotropicmedicationsanddeterminedthatitwill
continuetoevaluatetheseconcernsinfuturereviews. Furthermore,ACFplanstoprovideguidancefor
Statesthatmustdevelopimprovementplansinthisarea. Finally,ACFrestatedthatthetopicofoversight
ofpsychotropicmedicationswillbeaddressedwithitsconstituencygroupofStatefostercaremanagers.
RelevantReport:OEI-07-15-00380(September2018)
27 Indian Health Service (IHS)
IHS,withanestimatedannualbudgetof$9.1billioninFY2022,isthe
RelevantTMCs:
largestHHSprogramservingtheAmericanIndianandAlaskaNative
 StrengtheningCoordinationfor
(AI/AN)community,providingorfundinghealthcareservicesfor
BetterProgramsandServices
approximately2.6millionAI/ANswhobelongto574federally
 SafeguardingtheWell-Beingof
recognizedTribesin37States. IHSservicesareadministeredthrough
HHSBeneficiaries
asystemof12areaofficesand170IHSandtriballymanagedservice
units. IHSfaceslongstandingchallengesthathavehindereditsabilitytoprovidequalitycare,ensure
soundmanagementofFederalfunds,andcomplywithMedicarestandards. OIGsbodyofIHSwork
continuestofocusonimprovingthequalityofcaredeliveredbyIHS,itsmanagement,andits
infrastructure(includingITsystems). OIGhasalsoreviewedtheuseoffundsacrossHHSprogramsthat
servetheAI/ANcommunity.
Top Unimplemented Recommendation
As a management priority, IHS should develop and implement a staffing program
20.
forrecruiting, retaining, and transitioningstaff and leadership to remote hospitals.
Key OIG Findings
IHShashadchronicissueswithrecruitingandretaininganadequateworkforceinitshospitals. These
issueshaveaffectedthestabilityofIHShospitalservicesandcontinuityofcare,promptedfacilitiesto
updatepoliciesrelatedtopatientprotections,andlimitedtheclinicalsupportandguidancethatIHSArea
Officesareabletoprovide. Notably,IHSclosedtheRosebudHospitalemergencydepartmentin
December2015duetoimmediatejeopardydeficienciesandstaffingshortages. IHSreopenedthe
hospitalsemergencydepartmentinJuly2016,butitwasagaincitedwithanimmediatejeopardy
deficiencyinJuly2018. LongstandingproblemsatRosebudHospitalremainaconcern,including
difficultieswithrecruitingandretainingstaffandfrequentchangesinleadership. AlthoughIHShasmade
significantimprovementssincetheclosure,itcontinuestostrugglewithsecuringadequateonsitestaffing
andleadership,asindicatedbyrecentdeficiencies. InearlierOIGworkthatincludedallIHS-runhospitals,
theinabilitytorecruitandretainneededstaffandthedependenceonactingpersonnelandcontracted
providersemergedaskeychallengesforhospitaladministrators. IHSalsoreportedtoOIGthatitwas
concernedthattheCOVID-19pandemiccouldexacerbatestaffingchallenges.
Progressin ImplementingtheRecommendation
IHSstatedthatitwouldassembleataskforcetocreateaworkforceplanthatwasexpectedtobe
completedbyMay2020. However,itsinitiationoftheworkforceplanwasdelayedbyanumberof
factors,includingitspriorityresponsetotheCOVID-19publichealthemergency.
PriortotheCOVID-19publichealthemergency,IHSpublishedinFebruary2019a5-yearstrategicplanfor
FYs2019through2023. Thestrategicplansobjectivesincludeacommitmenttorecruitandretain
qualitystaffthroughoutIHS,includinghospitals. Asapartoftheimplementationplanforthisobjective,
28 IHSinJuly2020initiatedthedevelopmentofamultidisciplinary,senior-levelworkinggrouptodevelopa
comprehensiveworkforceplantoaddressrecruitment,training,andplacementofstaffinhospital
leadershippositions,particularlyinremotelocations. Theworkgroupcompletedthecomprehensive
workforceplanandmaderecommendationstoensurecurrentandfuturesuccessionplanningforIHS
hospitalleadershipinSeptember2020. IHSstatedthatshiftsinprioritiesinresponsetotheCOVID-19
pandemicdelayedprogressonimplementingtheworkgrouprecommendations,butitplanstoreevaluate
therecommendationsinFY2023.
RelevantReports:OEI-06-20-00700(September2021);OEI-06-19-00330(July2019);
OEI-06-17-00270(July2019);OEI-06-14-00011(October2016);OEI-06-16-00390(August2019)
29 National Institutes of Health (NIH)
Withanannualbudgetofapproximately$45billioninFY2022,NIHis
RelevantTMC:
theNationsmedicalresearchagencyandthelargestgrant-making
 EnsuringtheFinancialIntegrity
agencyinHHS. Itismadeupof27InstitutesandCenters(ICs),each
ofHHSPrograms
withitsownspecificresearchagenda. Morethan84percentofNIHs
fundingisawardedforextramuralresearch,largelythrough
competitivegrants. Numerouscongressionalcommitteeshave
expressedconcernsaboutpotentialthreatstotheintegrityoftaxpayer-fundedresearchandintellectual
property,includingintellectualpropertytheftanditsdiversiontoforeignentities. OIGsworkfocuseson
intellectualpropertyandcybersecurityprotections,compliancewithFederalrequirementsandNIH
grantsandcontractpolicies,andtheintegrityofgrantapplicationandselectionprocesses.
Top Unimplemented Recommendation
NIH should continue to build on its efforts to identify andmitigate potential
21.
foreign threats to research integrity.
Key OIG Findings
NIHsCenterforScientificReviewhasstrengthsinitsapproachtovettingnomineesabilitytobeeffective
peerreviewers. However,itsvettinggiveslittleattentiontoforeignaffiliationbeyondrequiringa
justificationforreviewerswhoarenotbasedinNorthAmerica. NIHenforcespoliciesandprocedures
thatprotectconfidentialinformationingrantapplicationshandledbypeerreviewers,butitcoulddo
moretosystemicallyanddirectlyaddressconcernsaboutforeignthreatstotheconfidentialityofthepeer
reviewprocess. Additionally,althoughNIHhasmadeprogressinoverseeingfinancialconflictsthat
extramuralgranteeinstitutionsreportedduringthepastdecade,itcoulddomoretoensurethe
adequacyandconsistencyofreviews. Forinstance,a2019reportfoundthatNIHcouldnotanddidnot
plantoidentifywhetherinvestigatorsfinancialconflictsofinterest(FCOIs)involveforeigninterests.
WealsofoundthatNIHhaslimitedpolicies,procedures,andcontrolsinplacetoensureinstitutions
reportallsourcesofresearchsupport,financialinterests,andaffiliations.
Progressin ImplementingtheRecommendation
NIHconcurredwithOIGsrecommendationtoupdateitsguidanceonvettingpeerreviewnominees. To
thisend,NIHhascentralizedthevettingofpeerreviewernomineesinitsOfficeofExtramuralResearch,
whichisnowresponsibleforpeerreviewnomineevettingacrosstheagency. NIHalsoconcurredwith
OIGsrecommendationtodeveloparisk-basedapproachtoidentifypeerreviewerswhomayposea
threattointegrity. NIHalsoisexploringwaystoconducttargeted,risk-basedoversightofpeerreviewers
usingriskindicatorsidentifiedthroughanalysesofresearchintegritythreatsandpeerreviewintegrity
violations. NIHconcurredwithOIGsrecommendationfromaJune2022reporttorequiregranteesto
reportwhetherinvestigators'significantfinancialinterestsandothersupportinvolveforeignentities. NIH
30 hastakenstepstoaddressourrecommendations. NIHneedstoprovidedocumentationofupdatestoits
policiesandtrainingmaterialstoaddressconcernsrelatedtoundueforeigninfluence.
RelevantReports:OEI-01-19-00160(September2019);OEI-05-19-00240(March2020);
OEI-03-20-00210(June2022)
31 Food and Drug Administration (FDA)
FDAistaskedwithprotectingpublichealthbyensuringthesafety,
RelevantTMC:
effectiveness,quality,andsecurityofhumanandveterinarydrugs,
 SafeguardingPublicHealth
vaccinesandotherbiologicalproducts,andmedicaldevices. FDAis
alsoresponsibleforregulatingtobaccoproductsandforthesafetyand
securityofmostofourNationsfoodsupply,cosmetics,dietary
supplements,andproductsthatgiveoffradiation. FDAhadanannualbudgetofapproximately$6.1
billioninFY2021. Itisresponsiblefortheoversightofmorethan$2.7trillioninconsumedfood,medical
products,andtobacco. FDA-regulatedproductsaccountforapproximately20percentofallU.S.
consumerspending. FDAregulatesabout78percentoftheU.S.foodsupply. OIGhasalonghistoryof
FDAworkfocusedontopicsrelatedtofoodsafety,drugproducts,andmedicaldevices,amongother
issues.
Top Unimplemented Recommendation
FDA should improve its use of Risk Evaluation and Mitigation Strategies (REMS) by
22.
enhancing the assessment review process, ensuring that assessment reviews are
timely, and strengthening REMS to better address the opioid crisis.
Key OIG Findings
REMSisadrugsafetyprogramthatisintendedtomitigateaspecificseriousriskassociatedwiththe
useofadrug,andFDAhasusedREMSastooltomitigatemisuseofopioids. FDAspecifiesthe
requirementsandapprovesREMS. However,thedrugmanufacturerisresponsiblefordevelopingand
implementingtheprogram. AlthoughREMShasthepotentialtohelpaddresstheopioidcrisis,OIG
foundthatdataqualityissuesmadeitchallengingforFDAtodeterminewhetherREMSforopioidshas
beeneffective. Inadditiontolimitationsindatafromdrugmanufacturers,FDAfacedmeasurement
challenges,suchasalackofbaselinedata,limitedsurveillancedata,andaninabilitytodistinguishthe
effectsofREMSseparatefromotherinitiativesaddressingopioidmisuse. Furthermore,someopioid
manufacturershaveengagedindeceptivemarketingpracticesthatunderminedREMS'seducational
messagesregardingrisk.
Progressin ImplementingtheRecommendation
FDAisintheprocessofupdatingtworelevantREMSManualsofPoliciesandProceduresand
Guidance. FDAhasalsoundertakenanumberofactivitiesandisplanningadditionalactivitiesrelated
toopioidprescribereducation. However,OIGstillencouragesFDA,inre-examiningthefeasibilityof
mandatorytraining,torevisitrequiringmanufacturerstoconductmoreaggressiveoutreachor
partneringwithStatemedicallicenseboards. FDAhasalsoreportedthatitsnewpatientregistry
appearstobeoperationalandfunctioningasintended. Allpatientswhoreceivedatleastone
32 prescriptionforatransmucosalimmediate-releasefentanyl(TIRF)REMSappeartohavebeenenrolled
intheregistry. FDAiscurrentlyreviewingthefirstassessmentreportthatcontainsregistrydataand
analysis. OIGwillthenreviewtheassessment,includingdocumentationoftheextenttowhichFDA
identifiedknownareasofrisk,suchasinappropriateconversionsandoff-labelprescribing.
RelevantReports:OEI-04-11-00510(February2013);OEI-01-17-00510(September2020)
33 General Departmental
InFY2021,HHSreportedatotalofapproximately$1.5trillionin
RelevantTMCs:
expenditures. HHSistheprincipalU.S.departmentforprotectingthe
 SafeguardingPublicHealth
healthofallAmericansandprovidingessentialhumanservices. Italso
 HarnessingDataToImprovethe
isresponsibleforcoordinatingandcollaboratingacrossitsprograms
HealthandWell-Beingof
andwithotherFederalagencies,aswellasoutsidetheFederal
Individuals
GovernmentwithTribal,Stateandlocalgovernments,international  SafeguardingtheWell-Beingof
entities,industry,andotherstakeholders. TheCOVID-19pandemic HHSBeneficiaries
underscoresthecriticalimportanceofeffectivecoordinationin  Strengthening
emergencypreparednessandresponse. Moreover,allofHHShasto CoordinationforBetter
bevigilantinprotectingprogramsanddatafromcyberattacks. OIGs ProgramsandServices
workrevealstheimportanceofeffectiveandcollaborative  EnsuringtheFinancial
managementwithinHHSandwithHHSspartners,andareasfor IntegrityofHHSPrograms
improvement.
Top Unimplemented Recommendations
HHS should ensure it has effective response plans and provides necessary guidance
23.
to effectively respond to domestic and international public health emergencies.
Key OIG Findings
InanAugust2019report,OIGfoundthatHHSdidnotalwaysefficientlyplanandcoordinateits
internationalresponseeffortsduringtheEbolahealthcrisis. Specifically,OIGfoundthatHHShadno
strategicframeworkinplacetocoordinateglobalhealthsecurityattheinternationalordepartmental
levelsbeforetheEbolaoutbreakin2014and2015. OIGalsofoundthatHHSwasnotpreparedtodeploy
theresourcesneededforsuchalarge-scaleinternationalresponse,andHHSdidnothaveinplaceinternal
orexternalcommunicationchannelsforrespondingtoaninternationalpublichealthemergency. Inan
April2020report,OIGfoundthatHealthCareCoalitions(HCCs),whichhelppreparecommunityhealth
caresystemstorespondtopublichealthemergenciesandotheremergencies,suchasnaturaldisasters,
faceddevelopmentalchallengesfollowingnewAdministrationforStrategicPreparednessandResponse
(ASPR)andCMSrequirementsestablishedin2017. Specifically,OIGfoundthatsomehospital
preparednessprogram(HPP)requirementsandsomeASPRguidancewerenotclear. Unclear
requirementsandguidancemaylimittheabilityofHCCstoprepareforawholecommunityresponseto
publichealthemergencies.
Progressin ImplementingtheRecommendation
HHShasnotprovidedOIGwithitsfinalmanagementdecisiononitsinternationalpreparednessefforts,
andtherecommendationsassociatedwiththisreviewremainunimplemented. Asaresultofthese
unimplementedrecommendations,alongwithGAOsrecentelevationofHHSsleadershipand
34 coordinationofpublichealthemergenciestoitsHighRiskList(January2022),OIGhasinitiatedanew
reviewofHHSsemergencyresponsecapabilities.
Regardingdomesticemergencypreparednessefforts,ASPRconcurredwithourrecommendationand
indicatedthatitmayclarifyfutureguidanceandcontinuetobuildandleveragecollaborationwithCMS
regardingemergencypreparednessConditionsofParticipation(CoPs)andcontinuemakingresources
availabletoHCCs. ASPRalsostatedthatitwillcontinuetoworkwithpartners,includingnational
professionalassociations,toprovideinformationontheCMSemergencypreparednessCoPs,and
programandpolicyupdates. However,ASPRhasnotprovidedOIGwithitsfinalmanagementdecisionon
itsdomesticemergencypreparednessefforts.
RelevantReports:A-04-16-03567(August2019);OEI-04-18-00080(April2020)
HHS should improve administration and management of contracts related to
24.
inherently governmental functions and personalservices. HHS should also provide
training to political appointees and senior leaders related to contract
administration.
Key OIG Findings
WedeterminedHHScontractsforCMSsstrategiccommunicationsservicesduringourauditperiod
June1,2017,throughApril30,2019,werenotadministeredandmanagedinaccordancewithFederal
requirements. Specifically,asubcontractorindividualwasallowedtoperforminherentlygovernmental
functions,suchasmakingmanagerialdecisionsanddirectingFederalemployees. Wealsodetermined
thatthesenonpersonalstrategiccommunicationsservicescontractswereadministeredaspersonal
servicescontracts. Improvingadministrationandmanagementofcontractsbytrainingpolitical
appointeesandseniorleadersiscriticaltoensuringtheproperadministrationoffutureGovernment
contracts.
Progressin ImplementingtheRecommendation
HHSbeganconductingaspecialreviewofservicecontractsawardedandadministeredbythe
Departmentsoperatingandstaffdivisions. HHSstatedthatthepurposeofthisreviewistoassessand
identifytheimplicationsofcontractorsperforminginherentlygovernmentalfunctionsorcloselyrelated
functions;toensurethatpersonalservicecontractsenteredintoareperformedinaccordancewith
applicablelawsandregulations;andthatsafeguardsareinplacetoensurethatnonpersonalservice
contractsarenotadministeredaspersonalservicecontracts. Moreover,HHSstatedthatimplementation
ofapermanentprocurementmanagementoversightreviewstructureisbeingdevelopedtoprovide
furtheroversightoftheHHSacquisitionportfolio. HHSstatedthatitalsointendstodevelopbriefing
materialsemphasizingtheappropriateuseofservicecontractsandgoverningrulesaspartofHHSs
overallethicstrainingforallpoliticalappointeesandseniorleaders.
RelevantReport:A-12-19-20003(July2020)
35 HHS should ensure that cybersecurity incidentresponse capabilities are fully
25.
implemented across the Department.
Key OIG Findings
HHSdidnotsufficientlyimplementcybersecurityincidentresponsecapabilitiesacrossallOpDivsanddid
notsufficientlyassessorobtainassuranceofcompliancebytheOpDivswiththeHHScybersecurity
incidentresponsepolicy. Furthermore,HHSdidnoteffectivelydefinecybersecurityincidentresponse
rolesorresponsibilities,ensurethatcloudandservicecontractorsmetcybersecurityincidentresponse
reportingasrequiredbytheircontracts,orestablishadequateoversight,guidance,andcoordinationover
itscybersecurityincidentresponseprocesstoensureOpDivsimplementedadequateresponse
capabilities. Finally,HHSdidnotcreateapolicytomanagewaiversforsystemsthatdidnotmeetHHSs
securityrequirements.
Progressin ImplementingtheRecommendation
HHSprovidedevidencethatithadtakenseveralstepstoimplementandaddresscybersecurityincident
responsecapabilitiesacrossallOpDivsandComponentsbydefiningresponserolesandresponsibilities.
However,HHSshouldensurethatallOpDivscomplywithHHSscybersecurityincidentresponsepolicy
thatcloudandservicecontractorsmeetcybersecurityincidentresponsereportingasrequiredbytheir
contracts. ToaddresstheresponsecapabilitiesacrosstheDepartment,HHSprovidedevidenceofthe
efforttakenbytwoOpDivsbut,duetobudgetandcontractingissues,oneoftheOpDivswasnotableto
completeitsimplementation.
RelevantReport:A-18-17-04002(May2020)
36 IMPLEMENTED:Top 25Recommendation From 2021 Edition
HHSshouldensurethatallfuturewebapplicationdevelopmentsincorporatesecurity
requirementsfromanindustry-recognizedwebapplicationsecuritystandard. A-18-18-08500
UPDATE:HHSprovidedOIGwiththeHHSPolicyforSoftwareDevelopmentSecureCodingPractices,
whichincludesgenerallyacceptablesecurecodingpracticesin12areas(e.g.,userauthentication,
passwordcomplexity,andaccesscontrol)fromtheOpenWebApplicationSecurityProject. Itisstatedin
thepolicythattheOpDivsmustupdateeachareawithsecurecodingrecommendationsspecifictoeach
OpDivspoliciesandrisktolerance.
37 Appendix A: Unimplemented Legislative
Recommendations
ThisappendixidentifiesOIGunimplementedrecommendationsthatrequirelegislativechangeto
implementorthatmightbestbeaddressedbylegislation. ItincludesseveralofOIGstop25
unimplementedrecommendations,asindicatedbelow. TherecommendationsaregroupedbyOpDiv.
Somerecommendationsalsoincludeestimatedcostsavingsthatwebelievewouldbegeneratedifthe
specificrecommendation(s)wereimplemented.
Administration forChildren and Families(ACF)
Recommendation RelevantReport(s)
ACF should conduct oversight activities to identify States that ACFCannotEnsureThatAllChildVictimsof
maynotappointaguardianadlitemtoeverychildvictimwho AbuseandNeglectHaveCourt
undergoesajudicialproceeding,seekingstatutoryauthorityas Representation,OEI-12-16-00120(March
necessary. 2021)
CentersforMedicare & Medicaid Services (CMS)
Recommendation RelevantReport(s)
CMSshouldevaluatethepotentialimpactsofupdatingtheDRG MedicareandBeneficiariesPayMorefor
windowpolicytoincludeaffiliatedhospitals,andseekthe PreadmissionServicesatAffiliated
necessarylegislativeauthoritytoupdatethepolicyas HospitalsThanatWhollyOwnedSettings,
appropriate. OEI-05-19-00380(December2021)
CMSshouldseeklegislativeauthoritytoestablishamechanism MedicareLaboratoryTestExpenditures
tocontrolcostsforautomatedchemistrytests. Increasedin2018,DespiteNewRate
Reductions,OEI-09-19-00100(August
2020)
CMSshouldimplementamethodtorecoverfromStatesthe StatesCouldDoMoreToPrevent
Federalshareofinappropriatemanagedcarecapitation TerminatedProvidersFromServing
paymentsassociatedwithterminatedproviders. MedicaidBeneficiaries,
OEI-03-19-00070(March2020)
CMSshouldtakestepstodisallowFederalreimbursementsto Twenty-ThreeStatesReportedAllowing
StatesforexpendituresassociatedwithunenrolledMCO UnenrolledProvidersToServeMedicaid
networkproviders,includingseekingnecessarylegislative Beneficiaries, OEI-05-19-00060 (March
authority. 2020)
CMSshouldseeklegislativeauthoritytoalignMedicare MedicareAllowableAmountsforCertain
allowableamountsfortheseitemswithpaymentsmadeby OrthoticDevicesAreNotComparableWith
select,non-Medicarepayers. PaymentsMadebySelectNon-Medicare
Payers,A-05-17-00033(October2019)
EstimatedSavings:$337,547,542forCYs2012through2015
38 Recommendation RelevantReport(s)
CMSshouldseeklegislativechangetoexcludeauthorized MedicaidCouldSaveHundredsofMillions
genericdrugtransactionstosecondarymanufacturersfromthe byExcludingAuthorizedGenericDrug
AMPcalculationofthebrandnamedrug. Thischangemay TransactionstoSecondaryManufacturers
fromBrandNameDrugsAverage
increasemanufacturerMedicaidrebateobligationsbyhundreds
ManufacturerPriceCalculations,
ofmillionsofdollarseachyear.
A-06-18-04002(April2019)
EstimatedSavings:$595millioninCY2015
Top25Recommendation#6 SignificantVulnerabilitiesExistinthe
HospitalWageIndexSystemforMedicare
CMSshouldseeklegislativeauthoritytocomprehensively Payments,A-01-17-00500
reformthehospitalwageindexsystem. (November2018)
CMSshouldtakeallnecessaryactions,includingseeking MedicareImproperlyPaidSuppliersfor
legislativeauthority,torequiresupplierstorefundto DurableMedicalEquipment,Prosthetics,
beneficiariesincorrectlycollectedMedicarePartBdeductible Orthotics,andSuppliesProvidedto
andcoinsuranceamountsforitemsandservicesreimbursable BeneficiariesDuringInpatientStays,
underMedicarePartA. A-09-17-03035(November2018)
CMSshouldensurethattheMedicareDrugIntegrityContractor TheMEDICProducedSomePositiveResults
(MEDIC)hastheabilitytorequiremedicalrecordsfrom ButMoreCouldbeDoneToEnhanceits
prescribersofPartDdrugsnotundercontractwithplan Effectiveness,OEI-03-17-00310(July2018)
sponsors,obtaininglegislativeauthorityifnecessary.
Top25Recommendation#11 VulnerabilitiesintheMedicareHospice
ProgramAffectQualityCareandProgram
CMSshouldmodifythepaymentsforhospicecareinnursing Integrity:AnOIGPortfolio,OEI-02-16-00570
facilities,obtaininglegislativeauthorityifnecessary. (July2018)
CMSshouldsetfirmdeadlinesformarketplacestofullydevelop CMSDidNotProvideEffectiveOversightTo
systemfunctionalityforverifyingapplicantseligibilityand EnsureThatStateMarketplacesAlways
resolvinginconsistencies,assesspotentialenforcement ProperlyDeterminedIndividualsEligibility
mechanismstoensurethatmarketplacesmeetthosedeadlines, forQualifiedHealthPlansandInsurance
andseeklegislativeauthoritytoestablishmechanismsthathave AffordabilityPrograms,A-09-16-01002
beenidentified. (September2017)
CMSshouldseeklegislationtoeliminatethelump-sumpayment MedicareCouldSaveMillionsbyEliminating
optionforallpowermobilitydevices. theLump-SumPurchaseOptionforAll
PowerMobilityDevices,A-05-15-00020
(May2017)
CMSshouldexplorewaystoprotectbeneficiariesinoutpatient VulnerabilitiesRemainUnderMedicares
staysfrompayingmorethantheywouldhavepaidasinpatients, 2-MidnightHospitalPolicy,
includingbylegislativeauthorityifnecessary. OEI-02-15-00020(December2016)
39 Recommendation RelevantReport(s)
CMSshouldrequiretheuseofclaim-levelmethodstoidentify StateEffortstoExclude340BDrugsfrom
340Bclaims,obtaininglegislativeauthorityifnecessary. MedicaidManagedCareRebates,
OEI-05-14-00430(June2016)
CMSshouldevaluatetheextenttowhichMedicarepayment TheMedicarePaymentSystemforSkilled
ratesfortherapyshouldbereduced. NursingFacilitiesNeedsToBeReevaluated,
OEI-02-13-00610(September2015)
CMSshouldseeklegislationtoadjustcritical-accesshospital MedicareCouldHaveSavedBillionsat
(CAH)swing-bedreimbursementratestothelowerSNFrates. CriticalAccessHospitalsIfSwing-Bed
ServicesWereReimbursedUsingtheSkilled
EstimatedSavings:$4.1billionovera6-yearperiodfrom NursingFacilityProspectivePayment
CY2005throughCY2010 SystemRates,A-05-12-00046(March2015)
CMSshouldseeklegislativeauthoritytomodifyhow MedicareBeneficiariesPaidNearlyHalfof
coinsuranceiscalculatedforoutpatientservicesreceivedat theCostsforOutpatientServicesatCritical
CAHs. AccessHospitals,OEI-05-12-00085(October
2014)
CMSshouldseeklegislativechangetopreventStatesfromusing IowaHasShiftedMedicareCost-Sharingfor
StateSupplementaryPaymentstoshiftMedicarePartB DualEligiblestotheFederalGovernment,
premiumcostsforfull-benefitdualeligiblestotheFederal OEI-07-13-00480(April2014)
Government.
CMSshouldseeklegislationthatwouldexemptreduced MedicareandBeneficiariesCouldSave
expendituresresultingfromloweroutpatientprospective BillionsIfCMSReducesHospitalOutpatient
paymentsystem(PPS)paymentratesfrombudgetneutrality DepartmentPaymentRatesforAmbulatory
adjustmentsforproceduresapprovedbyambulatorysurgical SurgicalCenter-ApprovedProceduresto
centers(ASCs). AmbulatorySurgicalCenterPaymentRates,
A-05-12-00020(April2014)
EstimatedSavings:Upto$15billionovera6-yearperiodfrom
CYs2012to2017
CMSshouldseeklegislativeauthoritytoexpandthediagnosis- MedicareandBeneficiariesCouldRealize
relatedgroupwindowtoincludeadditionaldayspriortothe SubstantialSavingsIftheDRGWindow
inpatientadmission. WereExpanded,OEI-05-12-00480(February
2014)
EstimatedSavings:$318millionin20114
4Theestimated$318millioninsavingsisbasedonOIGsanalysisofclaimsforservicesprovidedjustpriortothewindowor
providedataffiliatedhospitalsduringthewindowin2011.
40 Recommendation RelevantReport(s)
CMSshouldseeklegislativeauthorityto: MostCriticalAccessHospitalsWouldNot
 removeNecessaryProviderCAHspermanent MeettheLocationRequirementsIfRequired
exemptionfromthedistancerequirement,allowing ToRe-EnrollinMedicare,OEI-05-12-00080
CMStoreassesstheseCAHs;and (August2013)
 revisetheCAHConditionsofParticipationtoinclude
alternativelocation-relatedrequirements.
EstimatedSavings:$449millionin20115
CMSshouldexaminetheadditionalpotentialimpactsof MedicareCouldCollectBillionsIf
establishingaprescriptiondrugrebateprogramunderMedicare PharmaceuticalManufacturersWere
PartBand,ifappropriate,seeklegislativechange. RequiredToPayRebatesforPartBDrugs,
OEI-12-12-00260(September2013)
CMSshouldconsiderseekingalegislativechangetorequire ComparisonofAverageSalesPricesand
manufacturersofPartB-covereddrugstosubmitbothaverage AverageManufacturerPrices:AnOverview
salespricesandaveragemanufacturerprices. of2011,OEI-03-12-00670(January2013)
Top25Recommendation#3 LeastCostlyAlternativePolicies:Impacton
ProstateCancerDrugsCoveredUnder
CMSshouldconsiderseekinglegislativeauthoritytoimplement MedicarePartB,OEI-12-12-00210
leastcostlyalternativepoliciesforPartBdrugsunder (November2012)
appropriatecircumstances.
CMSshouldworkwithCongresstorequirethatmanufacturers MedicarePaymentsforNewlyAvailable
offirstgenericssubmitmonthlyaveragesalespricedataduring GenericDrugs,OEI-03-09-00510
initialgenericavailability. (January2011)
CMSshouldseeklegislativeauthorityoradministrativelyrequire StatusoftheRuralHealthClinicProgram,
ruralhealthclinicapplicantstodocumentneedandtheimpact OEI-05-03-00170(August2005)
onaccesstohealthcareinruralunderservedareas.
Food and Drug Administration (FDA)
Recommendation RelevantReport(s)
FDAshouldseeklegislativeauthoritytoincludeinformation OwnershipButNotPhysicalMovement
aboutadrugproductscompletephysicalpaththroughthe ofSelectedDrugsCanBeTracedThrough
supplychainondrugproducttracinginformation. theSupplyChain,OEI-05-17-00460
(February2020)
TopRecommendation#22 FDALacksComprehensiveDataTo
DetermineWhetherRiskEvaluationand
FDAshouldseeklegislativeauthoritytoenforceFDAassessment MitigationStrategiesImproveDrugSafety,
plans. OEI-04-11-00510(February2013)
5Medicareandbeneficiarieswouldhavesaved$449millionifCMShaddecertifiedCAHsthatwere15orfewermilesfromthe
nearesthospitalsin2011.
41 Recommendation RelevantReport(s)
FDAshouldseekstatutoryauthoritytoimposecivilmonetary DietarySupplements:CompaniesMayBe
penaltiesoncompaniesthatdonotcomplywithregistration DifficultToLocateinanEmergency,
requirements. OEI-01-11-00211(October2012)
FDAshouldseekexplicitstatutoryauthoritytoreview DietarySupplements:Structure/Function
substantiationforstructure/functionclaimstodetermine ClaimsFailToMeetFederalRequirements,
whetherclaimsaretruthfulandnotmisleading. OEI-01-11-00210(October2012)
FDAshouldconsiderseekingstatutoryauthoritytoimposecivil FDAInspectionsofDomesticFoodFacilities,
penaltiesthroughadministrativeproceedingsagainstfacilities OEI-02-08-00080(April2010)
thatdonotvoluntarilycomplywithstatutoryandregulatory
requirements.
HealthResourcesandServicesAdministration (HRSA)
Recommendation RelevantReport(s)
HRSAshouldshare340BceilingpriceswithStates,obtaining StateMedicaidPoliciesandOversight
legislativeauthorityifnecessary. ActivitiesRelatedto340B-PurchasedDrugs,
OEI-05-09-00321(June2011)
NationalInstitutesofHealth(NIH)
Recommendation RelevantReport(s)
NIHshouldpromulgateregulationsthataddressinstitutional InstitutionalConflictsofInterestatNIH
FCOIs. Grantees,OEI-03-09-00480(January2011)
42 Appendix B: Significant Unimplemented
Recommendations
ThisappendixincludesalistofsignificantunimplementedrecommendationscompiledfromOIGaudit
andevaluationreports. Therecommendationsrepresentopportunitiestoachieveexpectedimpact
throughcostsavings,improvementsinprogrameffectivenessandefficiency,andincreasedqualityof
careandsafetyamongprogrambeneficiaries.
ThisappendixincludessignificantrecommendationsfromauditsandevaluationsissuedthroughJuly1,
2022. Therecommendationsdescribeproblems,abuses,ordeficienciesforwhichcorrectiveactionhas
notbeencompleted. TherecommendationsaregenerallygroupedbyOpDiv. Theappendixincludes
OIGstop25unimplementedrecommendations,asindicated. Notethattherecommendationsinthis
appendixincludetheexactwordingfromtheassociatedauditsorevaluations,someofwhichhasbeen
paraphrasedinsummariesofthetop25unimplementedrecommendations. Somerecommendations
alsoincludeestimatedcostsavingsthatwebelievewouldbegeneratedifthespecificrecommendation(s)
wereimplemented. Thehyperlinksprovidemoreinformationonthereport(s)relevanttoeach
recommendation.
CentersforMedicare & Medicaid Services(CMS)Medicare Parts A and B
Recommendation RelevantReport(s)
CMSshould: CMSCouldImprovetheDataItUses
 takeadditionalstepstovalidatetheinformationreportedin ToMonitorAntipsychoticDrugsin
MinimumDataSetassessmentsand NursingHomes,OEI-07-19-00490
 supplementthedataitusestomonitortheuseof (May2021)
antipsychoticdrugsinnursinghomes.
CMSshould: CMSUseofDataonNursingHome
 providedatatoconsumersonnursestaffturnoverandtenure, Staffing:ProgressandOpportunities
ToDoMore,OEI-04-18-00451(March
asrequiredbyFederallaw;
 considerresidentslevelsofneedwhenidentifyingnursing 2021)
homesforweekendinspections;
 ensuretheaccuracyofnon-nursestaffingdatausedonCare
Compare;and
 takeadditionalstepstostrengthenoversightofnursinghome
staffing.
Top25Recommendation#7 TrendTowardMoreExpensive
InpatientHospitalStaysinMedicare
WithrespecttoMedicareinpatienthospitalstays,CMSshould EmergedBeforeCOVID-19and
conducttargetedreviewsofMS-DRGsandstaysthatarevulnerableto WarrantsFurtherScrutiny,
upcoding,aswellashospitalsthatfrequentlybillforthem. OEI-02-18-00380(February2021)
Withrespecttonursinghomesurveys,CMSshould: OnsiteSurveysofNursingHomes
 clarifyexpectationsforStatestocompletebacklogsof DuringtheCOVID-19Pandemic:
standardsurveysandhigh-prioritycomplaintsurveys,
43 Recommendation RelevantReport(s)
 workwithStatestohelpovercomechallengeswithPPEand March23-May30,2020,
staffing,and OEI-01-20-00430(December2020)
 assesstheresultsofinfectioncontrolsurveysandrevisethe
surveysasappropriate.
CMSshould: StatesContinuedToFallShortin
 ensurethatallStatesreceivetrainingonCMSsupdated MeetingRequiredTimeframesfor
InvestigatingNursingHome
triageguidanceand
 identifynewapproachestoaddressthoseStatesthatare Complaints:2016-2018,
OEI-01-19-00421(September2020)
consistentlyfailingtomeettherequiredtimeframesfor
investigatingthemostseriousnursinghomecomplaints.
CMSshouldworkwithmanufacturersassociatedwitherrorsto SomeManufacturersReported
correctandresubmitaccurateproductdata. InaccurateDrugProductDatatoCMS,
OEI-03-19-00200(September2020)
CMSshould: SomeNursingHomesReported
 enhanceeffortstoensurenursinghomesmeetdailystaffing StaffingLevelsin2018RaiseConcerns;
ConsumerTransparencyCouldBe
requirementsand
 explorewaystoprovideconsumerswithadditional Increased,OEI-04-18-00450(August
2020)
informationonnursinghomesdailystaffinglevelsand
variability.
Top25Recommendation#7 HospitalsOverbilledMedicare$1Billion
byIncorrectlyAssigningSevere
ToattemptrecoveryofMedicareoverpayments,whichweestimateto MalnutritionDiagnosisCodesto
bevaluedat$1,024,623,449,CMSshould: InpatientHospitalClaims,
 reviewthe224,175inpatientclaimsinoursamplingframe A-03-17-00010(July2020)
thatwerenotpartofoursamplebutwerewithinthe
reopeningperiodtoidentifywhichwereincorrectlybilled
andrecoveridentifiedoverpayments;and
 reviewhowhospitalsareusingdiagnosiscodeE41for
nutritionalmarasmusanddiagnosiscodeE43forunspecified
severeprotein-caloriemalnutrition,andworkwithhospitals
toensurethattheycorrectlybillMedicarewhenusingsevere
malnutritiondiagnosiscodes.
CMSshouldrequirereconciliationofallhospitalcostreportswith HospitalsReceivedMillionsinExcessive
outlierpaymentsduringacost-reportingperiod. OutlierPaymentsBecauseCMSLimits
theReconciliationProcess,
EstimatedSavings:$125millionperyearforFYs2011through2014 A-05-16-00060(November2019)
CMSshouldreviewthe37,124outpatientclaimstotaling$1,162,562 MedicareMadeHundredsof
inpotentialoverpaymentstodeterminewhethertheoutpatient ThousandsofDollarsinOverpayments
facilitiesmettherequirementtobillforchroniccaremanagement forChronicCareManagementServices,
servicesand: A-07-17-05101(November2019)
 recoupanyoverpaymentsfromoutpatientfacilitiesand
 instructtheoutpatientfacilitiestorefundcorresponding
overchargestobeneficiaries.
44 Recommendation RelevantReport(s)
CMSshouldreviewMedicareallowableamountsfor161orthotic MedicareAllowableAmountsfor
deviceHealthcareProcedureCommonCodingSystemcodesforwhich CertainOrthoticDevicesAreNot
Medicareandbeneficiariespaidanestimated$337,547,542more ComparableWithPaymentsMadeby
thanselectnon-Medicarepayersand: SelectNon-MedicarePayers,
 adjusttheallowableamounts,asappropriate,using A-05-17-00033(October2019)
regulationspromulgatedunderexistinglegislativeauthority;
or
 iftheallowableamountscannotbeadjustedusing
regulationspromulgatedunderexistinglegislativeauthority,
seeklegislativeauthoritytoalignMedicareallowable
amountsfortheseitemswithpaymentsmadebyselectnon-
Medicarepayers;and
 routinelyreviewMedicareallowableamountsfornewand
preexistingorthoticdevicestoensurethatMedicare
allowableamountsareinalignmentwithpaymentsmadeby
selectnon-Medicarepayersorpricingtrends.
EstimatedSavings:$337,547,542forCYs2012through2015
CMSshoulddevelopafraudpreventionmodelspecifictoemergency MedicareIncorrectlyPaidProvidersfor
ambulancetransportsfromhospitalstoSNFstohelpensurethat EmergencyAmbulanceTransports
paymentsfortheseambulancetransportscomplywithFederal FromHospitalstoSkilledNursing
requirements. Facilities,A-09-18-03030(September
2019)
Estimatedcostsavings:$849,170duringCYs2015through2017(audit
period)and$119,548inCY2018
CMSshould: HospiceDeficienciesPoseRisksto
 expandthedeficiencydatathataccreditingorganizations MedicareBeneficiaries,
reporttoCMSandusethesedatatostrengthenitsoversight OEI-02-17-00020(July2019)
ofhospices;
 includeonHospiceComparethesurveyreportsfromState
agencies;
 includeonHospiceComparethesurveyreportsfrom
accreditingorganizations,onceauthorityisobtained;and
 increaseoversightofhospiceswithahistoryofserious
deficiencies.
Top25Recommendation#1 SafeguardsMustBeStrengthenedTo
ProtectMedicareHospiceBeneficiaries
CMSshould:
FromHarm,OEI-02-17-00021(July
 strengthenrequirementsforhospicestoreportabuse,
2019)
neglect,andotherharm;
 strengthenguidanceforsurveyorstoreportcrimestolocal
lawenforcement;
 monitorsurveyors'useoftheImmediateJeopardycitation;
and
45 Recommendation RelevantReport(s)
 improveandmakeuser-friendlytheprocessforbeneficiaries
andcaregiverstomakecomplaints.
Top25Recommendation#1 IncidentsofPotentialAbuseand
NeglectatSkilledNursingFacilities
Withrespecttoidentifyinginstancesofpotentialabuseorneglect,
WereNotAlwaysReportedand
CMSshould:
Investigated,A-01-16-00509(June
 workwithSurveyAgenciestoimprovetrainingforthestaffof
2019)
SNFsonhowtoidentifyandreportincidentsofpotential
abuseorneglectamongMedicarebeneficiaries,
 requirethatSurveyAgenciesrecordandtrackallincidentsof
potentialabuseorneglectinSNFsandreferralsmadetolocal
lawenforcementandotheragencies,
 monitorSurveyAgenciesreportingoffindingsof
substantiatedabusetolocallawenforcement,and
 clarifyguidancetoclearlydefineandprovideexamplesof
incidentsofpotentialabuseorneglect.
Top25Recommendation#1 CMSCouldUseMedicareDataTo
IdentifyInstancesofPotentialAbuseor
Withrespecttoidentifyinginstancesofpotentialabuseorneglect,
Neglect,A-01-17-00513(June2019)
CMSshould:
 assessthesufficiencyofexistingFederalrequirements,such
asCoPsandsection1150BoftheAct,toreportsuspected
abuseandneglectofMedicarebeneficiaries,regardlessof
whereservicesareprovided,andstrengthenthose
requirementsorseekadditionalauthoritiesasappropriate;
 compileacompletelistofdiagnosiscodesthatindicate
potentialphysicalorsexualabuseandneglect;
 usethecompletelistofdiagnosiscodestoconductperiodic
dataextractsofallMedicareclaimscontainingatleastoneof
thecodesindicatingeitherpotentialabuseorneglectof
adultandchildMedicarebeneficiaries;and
 informStatesthattheextractedMedicareclaimsdataare
availabletohelpStatesensurecompliancewiththeir
mandatoryreportinglaws.
WithrespecttoMedicares3-dayinpatienthospitalstayrequirement, CMSImproperlyPaidMillionsofDollars
CMSshould: forSkilledNursingFacilitiesWhenthe
 requirehospitalstoprovideawrittennotificationto Medicare3-DayInpatientHospitalStay
beneficiarieswhosedischargeplansincludepost-hospital RequirementWasNotMet,
SNFcare,clearlystatinghowmanyinpatientdaysofcarethe A-05-16-00043(February2019)
hospitalprovidedandwhetherthe3-dayruleforMedicare
coverageofSNFstayswasmet(and,ifnecessary,CMS
shouldseekstatutoryauthoritytodoso);and
46 Recommendation RelevantReport(s)
 requireSNFstoobtainfromthehospitalorbeneficiary,at
thetimeofadmission,acopyofthehospitalswritten
notificationtothebeneficiaryandretainitinthe
beneficiarysmedicalrecord(and,ifnecessary,CMSshould
seekstatutoryauthoritytodoso).
EstimatedSavings:$84.2millionbasedonestimatesfromCY2013
throughCY2015
CMSshouldtakeallnecessaryactions,includingseekinglegislative MedicareImproperlyPaidSuppliersfor
authority,torequiresupplierstorefundtobeneficiariesincorrectly DurableMedicalEquipment
collectedMedicarePartBdeductibleandcoinsuranceamountsfor Prosthetics,Orthotics,andSupplies
itemsandservicesreimbursableunderMedicarePartA. ProvidedtoBeneficiariesDuring
InpatientStays,A-09-17-03035
(November2018)
Top25Recommendation#6 SignificantVulnerabilitiesExistinthe
HospitalWageIndexSystemfor
CMSandtheSecretaryofHealthandHumanServicesshouldrevisit MedicarePayments,A-01-17-00500
thepossibilityofcomprehensivereformofthehospitalwageindex (November2018)
system,includingtheoptionofacommuting-basedwageindex.
Iftherewillnotbecomprehensivereform,CMSshould:
 seeklegislativeauthoritytopenalizehospitalsthatsubmit
inaccurateorincompletewagedataintheabsenceof
misrepresentationorfalsification;
 seeklegislationtorepealthelawcreatingtheruralfloorwage
index;
 seeklegislationtorepealthehold-harmlessprovisionsin
Federallaw,allowingCMStocalculateeachareawageindex
basedonthewagedataofhospitalsthatreclassifyintothe
areaandhospitalsgeographicallylocatedintheareaprovided
thattheydonotreclassifyout;
 rescinditshold-harmlesspolicyrelatingtogeographically
reclassifiedhospitals'wagedata;and
 workwithMACstodevelopaprogramofin-depthwagedata
auditsatalimitednumberofhospitalseachyear,focusingon
hospitalswithwagedatathathighlyinfluencewageindexesin
theirareas.
Top25Recommendation#5 ManyInpatientRehabilitationFacility
StaysDidNotMeetMedicareCoverage
WithrespecttoMedicareinpatientrehabilitationfacilitystays,CMS andDocumentationRequirements,
shouldreevaluatetheIRFpaymentsystem,whichcouldinclude A-01-15-00500(September2018)
consideringthehigherrorratefoundinthisreportand
ComprehensiveErrorRateTestingreviewsinfutureacuteinpatient
rehabilitationservicepaymentreform,whichmaybeacomponentof
aunifiedpost-acute-carePPSsystem.
47 Recommendation RelevantReport(s)
Top25Recommendation#5 MedicareCouldHaveSaved
Approximately$993Millionin2017
CMSshouldexpandtheIRFtransferpaymentpolicytoapplytoearly and2018ifItHadImplementedan
dischargestohomehealthcare. Ifthisexpandedpolicyhadbeenin InpatientRehabilitationFacility
place,Medicarecouldhavesaved$993,134,059inCYs2017and TransferPaymentPolicyforEarly
2018. DischargestoHomeHealthAgencies,
A-01-20-00501(December2021)
EstimatedSavings:$993millioninCY2017and2018
CMSshouldexpandtheprice-substitutionpolicy. MedicarePartBDrugPayments:
ImpactofPriceSubstitutionsBasedon
EstimatedSavings:$2.7million6 2016AverageSalesPrices,
OEI-03-18-00120(August2018)
Top25Recommendations#11 VulnerabilitiesintheMedicareHospice
ProgramAffectQualityCareand
WithrespecttotheMedicarehospiceprogram,CMSshould: ProgramIntegrity:AnOIGPortfolio,
 analyzeclaimsdatatoinformthesurveyprocess; OEI-02-16-00570(July2018)
 developotherclaims-basedinformationandincludeiton
HospiceCompare;
 includeinHospiceComparedeficiencydatafromsurveys,
includinginformationaboutcomplaintsfiledandresulting
deficiencies;
 workwithitspartners,suchashospitalsandcaregivergroups,
tomakeavailableconsumer-friendlyinformationexplaining
hospicebenefitstobeneficiariesandtheirfamiliesand
caregivers;
 ensurethataphysicianisinvolvedindecisionstostartand
continuegeneralinpatientcare;
 analyzeclaimsdatatoidentifyhospicesthatengagein
practicesorhavecharacteristicsthatraiseconcerns;
 takeappropriateactionstofollowupwithhospicesthat
engageinpracticesorhavecharacteristicsthatraise
concerns;
 increaseoversightofgeneralinpatientcareclaimsandfocus
particularlyongeneralinpatientcareprovidedinSNFs,given
thehigherrateatwhichthesestayswereinappropriate;
 implementacomprehensiveprepaymentreviewstrategyto
addresslengthygeneralinpatientcarestayssothat
beneficiariesdonothavetoendureunnecessarilylongtime
periodsduringwhichtheirpainandsymptomsarenot
controlled;
6IfCMShadexpandeditsprice-substitutioncriteriatoincludecertainotherPartBdrugsin2016,Medicareanditsbeneficiaries
couldhavesaveduptoanadditional$2.7millionover1year.
48 Recommendation RelevantReport(s)
 developandexecuteastrategytoworkdirectlywithhospices
toensurethattheyareprovidingdrugscoveredunderthe
hospicebenefitasnecessaryandthatthecostsofdrugs
coveredunderthebenefitarenotinappropriatelyshiftedto
PartD;
 assessthecurrentpaymentsystemtodeterminewhat
changesmaybeneededtotiepaymentstobeneficiariescare
needsandqualityofcaretoensurethatservicesrendered
adequatelyservebeneficiariesneeds;
 adjustpaymentsbasedontheseanalyses,ifappropriate,to
ensurethatthepaymentsystemisalignedwithbeneficiary
needsandqualityofcare;and
 modifypaymentsforhospicecareinnursingfacilities.
CMSshould: CMSPaidPractitionersforTelehealth
 conductperiodicpostpaymentreviewsfortelehealthclaim ServicesThatDidNotMeetMedicare
editsthatcannotbeimplementedandimplementall Requirements,A-05-16-00058
telehealthclaimeditsand (April2018)
 workwithMedicarecontractorstoimplementalltelehealth
claimseditslistedintheManual.
EstimatedSavings:$3.7millionduringCYs2014and2015
CMSshoulddirectMedicarecontractorstorecoverthe$66,309,751in MedicareImproperlyPaidProvidersfor
identifiedimproperpayments. SpecimenValidityTestsBilledin
CombinationWithUrineDrugTests,
EstimatedSavings:$12.1millionovera5-yearperiodfromJanuary A-09-16-02034(February2018)
2017throughDecember2021.
CMSshould: EnhancementsNeededintheTracking
 identifystrategiestoincreaseMACscollectionofZone andCollectionofMedicare
ProgramIntegrityContractorsandUnifiedProgramIntegrity OverpaymentsIdentifiedbyZPICsand
Contractorsreferredoverpaymentsand PSCs,OEI-03-13-00630(September
 implementthesuretybondrequirementforhomehealth 2017)
providersandconsiderthefeasibilityofimplementingsurety
bondsforotherprovidersbasedonlevelofrisk.
CMSshouldcontinuetoworkwiththeAccreditedCommitteeto ShortcomingsofDeviceClaimsData
ensurethatthedeviceidentifierisincludedonthenextversionof ComplicateandPotentiallyIncrease
claimforms. MedicareCostsforRecalledand
PrematurelyFailedDevices,
A-01-15-00504(September2017)
CMSshouldseeklegislationtoeliminatethelump-sumpayment MedicareCouldSaveMillionsby
optionforallpowermobilitydevices. Ifsuchlegislationhadbeenin EliminatingtheLump-SumPurchase
placeduringCY2011throughCY2014,Medicarecouldhavesavedat OptionforAllPowerMobilityDevices,
leastanadditional$10,245,539. A-05-15-00020(May2017)
EstimatedSavings:$10.2millionfromCY2011throughCY2014
49 Recommendation RelevantReport(s)
WithrespecttoMedicares2-midnighthospitalpolicy,CMSshould: VulnerabilitiesRemainUnder
 conductroutineanalysisofhospitalbillingandtargetfor Medicares2-MidnightHospitalPolicy,
reviewthehospitalswithhighorincreasingnumbersofshort OEI-02-15-00020(December2016)
inpatientstaysthatarepotentiallyinappropriateunderthe
2-midnightpolicy,
 identifyandtargetforreviewtheshortinpatientstaysthat
arepotentiallyinappropriateunderthe2-midnightpolicy,
 analyzethepotentialimpactsofcountingtimespentasan
outpatienttowardthe3-nightrequirementforSNFservicesso
thatbeneficiariesreceivingsimilarhospitalcarehavesimilar
accesstotheseservices,and
 explorewaysofprotectingbeneficiariesinoutpatientstays
frompayingmorethantheywouldhavepaidasinpatients.
CMSshouldprovideguidancetohospicesregardingtheeffectson HospicesShouldImproveTheirElection
beneficiarieswhentheyrevoketheirelectionandwhentheyare StatementsandCertificationsof
dischargedfromhospicecare. TerminalIllness,OEI-02-10-00492
(September2016)
CMSshouldincludeinformationaboutpotentialeventsandpatient AdverseEventsinInpatient
harminitsqualityguidancetorehabilitationhospitals. RehabilitationHospitals:National
IncidenceAmongMedicare
Beneficiaries,OEI-06-14-00110
(July2016)
CMSshould: CMSIsTakingStepsToImprove
 takeappropriateactionagainsthospitalsandtheiroff- OversightofProvider-BasedFacilities,
campus,provider-basedfacilitiesthatweidentifiedasnot ButVulnerabilitiesRemain,
meetingrequirements;and OEI-04-12-00380(June2016)
 requirehospitalstosubmitattestationsforalloftheir
provider-basedfacilities.
CMSshould: TheMedicarePaymentSystemfor
 evaluatetheextenttowhichMedicarepaymentratesfor SkilledNursingFacilitiesNeedsToBe
therapyshouldbereducedand Reevaluated,OEI-02-13-00610
 adjustMedicarepaymentstoeliminateanyincreasesthatare (September2015)
unrelatedtobeneficiarycharacteristics.
CMSshouldseeklegislationtoadjustCAHswing-bedreimbursement MedicareCouldHaveSavedBillionsat
ratestothelowerSNFPPSratespaidforsimilarservicesatalternative CriticalAccessHospitalsIfSwing-Bed
facilities. ServicesWereReimbursedUsingthe
SkilledNursingFacilityProspective
EstimatedSavings:$4.1billionovera6-yearperiodfromCY2005 PaymentSystemRates,
throughCY2010 A-05-12-00046(March2015)
CMSshouldseeklegislativeauthoritytomodifyhowcoinsuranceis MedicareBeneficiariesPaidNearlyHalf
calculatedforoutpatientservicesreceivedatCAHs. oftheCostsforOutpatientServicesat
CriticalAccessHospitals,
OEI-05-12-00085(October2014)
50 Recommendation RelevantReport(s)
CMSshouldamendcurrentregulationstodecreasethePartB MedicarePartBPrescriptionDrug
paymentratesfordispensingandsupplyingfeestoratessimilarto DispensingandSupplyingFeePayment
thoseofotherpayers,suchasPartDandMedicaid. RatesAreConsiderablyHigherThan
theRatesPaidbyOtherGovernment
EstimatedSavings:Morethan$100millioninCY20117 Programs,A-06-12-00038(September
2014)
CMSshouldconductadditionalanalysistodeterminetheextentto VulnerabilitiesinMedicares
whichfinancialincentivesinfluencelong-termcarehospital Interrupted-StayPolicyforLong-Term
readmissiondecisions. CareHospitals,OEI-04-12-00490
(June2014)
CMSshould: CompoundedDrugsUnderMedicare
 explorethepossibilityofrequiringproviderstoidentifyon PartB:PaymentandOversight,
thePartBclaimthepharmacythatproducedthe OEI-03-13-00270(April2014)
compoundeddrugand
 explorethepossibilityofconductingdescriptiveanalysesof
PartBclaimsforcompoundeddrugs.
CMSshouldseeklegislativechangetopreventStatesfromusingState IowaHasShiftedMedicareCost-
SupplementaryPaymentstoshiftMedicarePartBpremiumcostsfor SharingforDualEligiblestotheFederal
full-benefitdualeligiblestotheFederalGovernment. Government,OEI-07-13-00480(April
2014)
CMSshould: MedicareandBeneficiariesCouldSave
 seeklegislationthatwouldexemptthereducedexpenditures BillionsIfCMSReducesHospital
asaresultofloweroutpatientPPSpaymentratesfrombudget OutpatientDepartmentPaymentRates
neutralityadjustmentsforASC-approvedprocedures, forAmbulatorySurgicalCenter-
 reducePPSpaymentratesforASC-approvedprocedureson ApprovedProcedurestoAmbulatory
beneficiarieswithno-riskorlow-riskclinicalneedsin SurgicalCenterPaymentRates,
outpatientdepartments,andthen A-05-12-00020(April2014)
 developandimplementapaymentstrategyinwhich
outpatientdepartmentswouldcontinuetoreceivethe
standardPPSpaymentrateforASC-approvedproceduresthat
mustbeprovidedinanoutpatientdepartmentbecauseofa
beneficiarysindividualclinicalneeds.
EstimatedSavings:Upto$15billionovera6-yearperiodfrom
CY2012throughCY2017
CMSshoulddistinguishpaymentsintheend-stagerenaldiseasebase Update:MedicarePaymentsforEnd
ratebetweenindependentandhospital-baseddialysisfacilities. StageRenalDiseaseDrugs,
OEI-03-12-00550(March2014)
7MedicarePartBwouldhavesavedanestimated$100millionifdispensingandsupplyfeepaymentratesweresimilarto
PartDorMedicaidrates.
51 Recommendation RelevantReport(s)
CMSshouldseeklegislativeauthoritytoexpandthediagnosis-related MedicareandBeneficiariesCould
groupwindowtoincludeadditionaldayspriortotheinpatient RealizeSubstantialSavingsIftheDRG
admission. WindowWereExpanded,
OEI-05-12-00480(February2014)
EstimatedSavings:$318millionin20118
CMSshouldworkwiththeAgencyforHealthcareResearchandQuality TheESRDBeneficiaryGrievance
toaddaquestiontotheConsumerAssessmentofHealthcare Process,OEI-01-11-00550
ProvidersandSystemstoassessbeneficiariesfearsofreprisal. (December2013)
CMSshouldinstructMedicarecontractorstoincreasemonitoringof MedicareHospitalOutlierPayments
outlierpayments. WarrantIncreasedScrutiny,
OEI-06-10-00520(November2013)
CMSshouldusetheMedicareAppealsSystemtomonitorMedicare TheFirstLeveloftheMedicareAppeals
contractorperformance. Process,20082012:Volume,
Outcomes,andTimeliness,
OEI-01-12-00150(October2013)
CMSshouldexaminetheadditionalpotentialimpactsofestablishinga MedicareCouldCollectBillionsif
prescriptiondrugrebateprogramunderMedicarePartBand,if PharmaceuticalManufacturersWere
appropriate,seeklegislativechange. RequiredToPayRebatesforPartB
Drugs,OEI-12-12-00260(September
2013)
CMSshouldseeklegislativeauthorityto: MostCriticalAccessHospitalsWould
 removeNecessaryProviderCAHspermanentexemptions NotMeettheLocationRequirements
fromthedistancerequirement,allowingCMStoreassess IfRequiredtoRe-enrollinMedicare,
theseCAHsand OEI-05-12-00080(August2013)
 revisetheCAHConditionsofParticipationtoinclude
alternativelocation-relatedrequirements.
EstimatedSavings:$449millionin20119
CMSshouldensurethatallclaimswithexceptioncodesareprocessed MedicareImproperlyPaidProviders
consistentlyandpursuanttoFederalrequirements. MillionsofDollarsforIncarcerated
BeneficiariesWhoReceivedServices
During2009Through2011,
A-07-12-01113(January2013)
Top25Recommendation#3 LeastCostlyAlternativePolicies:Impact
onProstateCancerDrugsCovered
CMSshouldconsiderseekinglegislativeauthoritytoimplementleast UnderMedicarePartB,
costlyalternativepoliciesforPartBdrugsunderappropriate OEI-12-12-00210(November2012)
circumstances.
8Theestimated$318millioninsavingsisbasedonOIGsanalysisofclaimsforservicesprovidedjustpriortothewindowor
providedataffiliatedhospitalsduringthewindowin2011.
9Medicareandbeneficiarieswouldhavesaved$449millionifCMShaddecertifiedCAHsthatwere15orfewermilesfromthe
nearesthospitalsin2011.
52 Recommendation RelevantReport(s)
CMSshouldimplementthehomehealthagencysuretybond SuretyBondsRemainanUnusedTool
requirement. ToProtectMedicareFromHome
HealthOverpayments,
OEI-03-12-00070(September2012)
CMSshouldadjusttheestimatednumberofevaluationand MusculoskeletalGlobalSurgeryFees
management(E&M)serviceswithinmusculoskeletalglobalsurgery OftenDidNotReflecttheNumberof
feestoreflecttheactualnumberofE&Mservicesbeingprovidedto EvaluationandManagementServices
beneficiaries,whichwouldhavereducedpaymentsinCY2007aloneby Provided,A-05-09-00053(May2012)
anestimated$49million,orusetheresultsofthisauditduringthe
annualupdateofthephysicianfeeschedule.
EstimatedSavings:$49million10
CMSshouldadjusttheestimatednumberofE&Mserviceswithin CardiovascularGlobalSurgeryFees
cardiovascularglobalsurgeryfeestoreflecttheactualnumberofE&M OftenDidNotReflecttheNumberof
servicesbeingprovidedtobeneficiaries,whichwouldhavereduced EvaluationandManagementServices
paymentsinCY2007alonebyanestimated$14.6million,orusethe Provided,A-05-09-00054(May2012)
resultsofthisauditduringtheannualupdateofthephysicianfee
schedule.
EstimatedSavings:$14.6million11
CMSshouldfacilitateaccesstoinformationnecessarytoensure MedicareAtypicalAntipsychoticDrug
accuratecoverageandreimbursementdetermination. ClaimsforElderlyNursingHome
Residents,OEI-07-08-00150(May
2011)
CMSshouldworkwithCongresstorequiremanufacturersoffirst MedicarePaymentsforNewlyAvailable
genericstosubmitmonthlyaveragesalespricedataduringinitial GenericDrugs,OEI-03-09-00510
genericavailability. (January2011)
CMSshouldadjusttheestimatednumberofE&Mserviceswithineye NationwideReviewofEvaluationand
globalsurgeryfeestoreflectthenumberofE&Mservicesactually ManagementServicesIncludedinEye
beingprovidedtobeneficiaries,orusethefinancialresultsoftheaudit andOcularAdnexaGlobalSurgeryFees
inconjunctionwithotherinformationduringtheannualupdatesofthe forCalendarYear2005,A-05-07-00077
physicianfeeschedule. (April2009)
EstimatedSavings:$97.6millionperyear12
CMSshouldseeklegislativeauthorityoradministrativelyrequirerural StatusoftheRuralHealthClinic
healthclinicapplicantstodocumentneedandimpactonaccessto Program,OEI-05-03-00170(August
healthcareinruralunderservedareas. 2005)
CMSshouldevaluatethepotentialimpactsofupdatingtheDRG MedicareandBeneficiariesPayMore
windowpolicytoincludeaffiliatedhospitals,andseekthenecessary forPreadmissionServicesatAffiliated
legislativeauthoritytoupdatethepolicyasappropriate. HospitalsThanatWhollyOwned
Settings,OEI-05-19-00380(December
2021)
10EstimatebasedonCY2007data.
11EstimatebasedonCY2007data.
12EstimatebasedonCY2005data.
53 Recommendation RelevantReport(s)
CMSshouldidentifyandimplementanappropriatewaytoaddress MedicareLacksConsistentOversightof
cybersecurityofnetworkedmedicaldevicesinitsqualityoversightof CybersecurityforNetworkedMedical
hospitals,inconsultationwithHHSpartnersandothers. DevicesinHospitals,OEI-01-20-00220
(June2021)
TopRecommendation#4 MedicareImproperlyPaidSuppliersan
Estimated$117MillionOver4Years
CMSshouldtakethefollowingactionsforsupplierclaimsforDMEPOS forDurableMedicalEquipment,
itemsprovidedtohospicebeneficiaries: Prosthetics,Orthotics,andSupplies
 implementapostpaymenteditprocesstodetectclaims ProvidedtoHospiceBeneficiaries,
submittedbysuppliersprocessedbeforeabeneficiarys A-09-20-03026(November2021)
noticeofelectionofhospicecareisprocessedintheCWF,
andinstructtheDMEMedicarecontractorstodenyDMEPOS
claimsidentifiedbytheeditprocessiftheydonothavethe
GWmodifier;
 directtheDMEandhospiceMedicarecontractorsorother
contractorsasappropriateto:
o conductprepaymentorpostpaymentreviewsofsupplier
claimsforDMEPOSitemsprovidedtohospice
beneficiariesandbilledwiththeGWmodifier,and
o analyzeMedicareclaimsdatatoprobeandeducate
suppliersthatusetheGWmodifierinappropriately;and
 studythefeasibilityofincludingpalliativeitemsandservices
notrelatedtoabeneficiarysterminalillnessandrelated
conditionswithinthehospiceperdiem. Sucharequirement
wouldeliminatetheneedforMedicaretomakeadditional
paymentsfortheseservicesconsistentwithCMSs
longstandingpositionthatpaymentsforservicesunrelatedto
abeneficiarysterminalillnessandrelatedconditionsshould
beexceptional,unusual,andraregiventhecomprehensive
natureoftheservicescoveredundertheMedicarehospice
benefit.
EstimatedSavings:$116.9millionfromJanuary2015throughApril
2019
CMSMedicare Parts C and D
Recommendation RelevantReport(s)
Top25Recommendation#3 MedicarePartDandBeneficiaries
CouldRealizeSignificantSpending
CMSshould: ReductionsWithIncreasedBiosimilar
 encouragePartDplanstoincreaseaccesstoanduseof Use,OEI-05-20-00480(March2022)
biosimilars,and
 monitorPartDplanssubmittedformulariestodetermine
whethertheydiscouragebeneficiariesfromusingbiosimilars.
54 Recommendation RelevantReport(s)
Top25Recommendation#8 ManyMedicareBeneficiariesAreNot
ReceivingMedicationtoTreatTheir
CMSshould: OpioidUseDisorder,OEI-02-20-00390
 conductadditionaloutreachtobeneficiariestoincrease (December2021)
awarenessaboutMedicarecoverageforthetreatmentof
opioidusedisorder,
 takestepstoincreasethenumberofprovidersandopioid
treatmentprogramsforMedicarebeneficiarieswithopioid
usedisorder,
 assistSAMHSAbyprovidingdataaboutthenumberof
Medicarebeneficiariesreceivingbuprenorphineinoffice-
basedsettingsandthegeographicareaswhereMedicare
beneficiariesremainunderserved,
 takestepstoincreasetheutilizationofbehavioraltherapy
amongbeneficiariesreceivingmedicationtotreatopioiduse
disorder,
 createanactionplanandtakestepstoaddressdisparitiesin
thetreatmentofopioidusedisorder,and
 collectdataontheuseoftelehealthinopioidtreatment
programs.
Top25Recommendation#10 MedicareAdvantageOrganizations
AreMissingOpportunitiesToUse
OrderingProviderIdentifiersTo
CMSshouldencourageMAOstoperformprogramintegrityoversight
ProtectProgramIntegrity,
usingorderingNPIs.
OEI-03-19-00432(April2021)
Top25Recommendation#9 BillionsinEstimatedMedicare
AdvantagePaymentsFromDiagnoses
WithrespecttoMedicareAdvantagepayments,CMSshould: ReportedOnlyonHealthRisk
 requireMAOstoflaganyMAO-initiatedHRAsinMA AssessmentsRaiseConcerns,
encounterdata, OEI-03-17-00471(September2020)
 providetargetedoversightofthe20MAOsthatdroverisk-
adjustedpaymentsresultingfromin-homeHRAsfor
beneficiarieswhohadnootherservicerecordsinthe2016
encounterdata,
 providetargetedoversightofthe10parentorganizationsthat
drovemostoftherisk-adjustedpaymentsresultingfrom
in-homeHRAs,
 requireMAOstoimplementbestpracticestoensurecare
coordinationforHRAs,and
 reassesstherisksandbenefitsofallowingin-homeHRAstobe
usedassourcesofdiagnosesforriskadjustmentsand
reconsiderexcludingsuchdiagnosesfromriskadjustments.
55 Recommendation RelevantReport(s)
Top25Recommendation#10 CMS'sEncounterDataLackEssential
InformationThatMedicareAdvantage
WithrespecttoMedicareAdvantageencounterdata,CMSshould: OrganizationsHavetheAbilityto
 requireMAOstosubmittheorderingproviderNPIon Collect,OEI-03-19-00430(August
encounterrecordsforDMEPOSandforlaboratory,imaging, 2020)
andhomehealthservices;and
 establishandimplementrejecteditsthatrejectencounter
recordsinwhichtheorderingproviderNPIisnotpresent
whenrequired,andrejectencounterrecordsthatcontainan
orderingproviderNPIthatisnotavalidandactiveNPIinthe
NationalPlanandProviderEnumerationSystemregistry.
Top25Recommendation#9 SomeMedicareAdvantage
CompaniesLeveragedChartReviews
CMSshould: andHealthRiskAssessmentsTo
 provideoversightofthe20MAcompaniesthathada DisproportionatelyDrivePayments,
OEI-03-17-00474(September2021)
disproportionateshareoftherisk-adjustedpaymentsfrom
chartreviewsandHRAs;
 takeadditionalactionstodeterminetheappropriatenessof
paymentsandcarefortheoneMAcompanythat
substantiallydroverisk-adjustedpaymentsfromchart
reviewsandHRAs;and
 performperiodicmonitoringtoidentifyMAcompaniesthat
hadadisproportionateshareofrisk-adjustedpaymentsfrom
chartreviewsandHRAs.
CMSshould: IssueBrief:KeyMedicareToolsTo
 allowrevocationofMedicareenrollmentforinappropriate SafeguardAgainstPharmacyFraud
billingofPartD, andInappropriateBillingDoNotApply
 applythePreclusionListpaymentprohibitionstopharmacies toPartD,
andotherprovidersthatdispensePartDdrugs,and OEI-02-15-00440(March2020)
 includeonthePreclusionListpharmaciesthatinappropriately
billPartD.
Top25Recommendation#9 BillionsinEstimatedMedicare
AdvantagePaymentsFromChart
CMSshould: ReviewsRaiseConcerns,
 conductauditsthatvalidatediagnosesreportedonchart OEI-03-17-00470(December2019)
reviewsintheMedicareAdvantageencounterdataand
 reassesstherisksandbenefitsofallowingtheuseofchart
reviewsthatarenotlinkedtoservicerecordsassourcesof
diagnosesforriskadjustment.
CMSshould: SomeMedicarePartDBeneficiaries
 takeactiontoreduceinappropriatepharmacyrejections; FaceAvoidableExtraStepsThatCan
 takeactiontoreduceinappropriatecoveragedenials;and DelayorPreventAccesstoPrescribed
Drugs,OEI-09-16-00411(September
2019)
56 Recommendation RelevantReport(s)
 providebeneficiarieswithclear,easilyaccessibleinformation
aboutsponsorperformanceproblems,includingthoserelated
toinappropriatepharmacyrejectionsandcoveragedenials.
Top25Recommendation#11 MedicarePartDIsStillPayingMillions
forDrugsAlreadyPaidforUnderthe
WithrespecttoMedicarePartDdrugs,CMSshould: PartAHospiceBenefit,
 workdirectlywithhospicestoensurethattheyareproviding A-06-17-08004(August2019)
drugscoveredunderthehospicebenefitand
 developandexecuteastrategytoensurethatPartDdoesnot
payfordrugsthatshouldbecoveredbythePartAhospice
benefit.
EstimatedSavings:$160.8millionayearinPartDtotalcosts
CMSshould: MedicareAdvantageAppeal
 enhanceitsoversightofMAOcontracts,includingthosewith OutcomesandAuditFindingsRaise
extremelyhighoverturnratesand/orlowappealrates,and ConcernsAboutServiceandPayment
takecorrectiveactionasappropriate;and Denials,
 providebeneficiarieswithclear,easilyaccessibleinformation OEI-09-16-00410(September2018)
aboutseriousviolationsbyMAOs.
CMSshould: TheMEDICProducedSomePositive
 requireplansponsorstoreportPartCandPartDfraudand Results butMoreCouldbe Doneto
abuseincidentsandthecorrectiveactionstakentoaddress EnhanceitsEffectiveness,
themtoacentralizedsystem; OEI-03-17-00310(July2018)
 providetheMEDICcentralizedaccesstoallPartCencounter
data;
 requirethatPartCandPartDprovidersandpharmaciesenroll
inMedicare;
 clarifytheMEDICsauthoritytorequirerecordsfrom
pharmacies,pharmacybenefitmanagers,andotherentities
undercontractwithPartCandPartDplansponsors;
 ensurethattheMEDIChastheabilitytorequiremedical
recordsfromprescribersofPartDdrugsnotundercontract
withplansponsorsand,ifnecessary,obtainlegislative
authority;and
 establishmeasurestoassesstheMEDICseffectiveness.
Top25Recommendation#10 Medicare Advantage Encounter Data
ShowPromiseforProgramOversight,
WithrespecttoMedicareAdvantageencounterdata,CMSshould: ButImprovementsAreNeeded,
 requireMAOstosubmitorderingandreferringprovider OEI-03-15-00060(January2018)
identifiersforapplicablerecords;
 ensurethatMAOssubmitrenderingprovideridentifiersfor
applicablerecords;and
 trackMAOs'responsestorejectedits.
57 Recommendation RelevantReport(s)
CMSshouldassignasingleentitytoassistMACsinmakingcoverage MACsContinueToUseDifferent
determinations. MethodsToDetermineDrug
Coverage,OEI-03-13-00450(August
2016)
CMSshould: CMSRegularlyReviewsPartC
 determinewhetheroutlierdatavaluessubmittedbyMAOs ReportingRequirementsData,ButIts
reflectinaccuratereportingoratypicalperformanceand FollowupandUseoftheDataAre
 useappropriatePartCreportingrequirementsdataaspartof Limited,OEI-03-11-00720(March
itsreviewsofMAOsperformance. 2014)
CMSshould: LessThanHalfofPartDSponsors
 reviewdatafromPartDplansponsorstodeterminewhy VoluntarilyReportedDataon
certainsponsorsreportedespeciallyhighorlownumbersof PotentialFraudandAbuse,
incidentsofpotentialfraudandabuse,relatedinquiries,and OEI-03-13-00030(March2014)
correctiveactions;and
 sharePartDplansponsorsdataonpotentialfraudandabuse
withallsponsorsandlawenforcement.
CMSshould: GapsinOversightofConflictsof
 definepharmacybenefitmanagersasentitiesthatcould InterestinMedicarePrescriptionDrug
benefitfromformularydecisions; Decisions,OEI-05-10-00450(March
 establishminimumstandardsrequiringsponsorstoensure 2013)
thatsafeguardsareestablishedtopreventimproprieties
relatedtoemploymentbytheentitythatmaintainsthe
MedicarePartDPharmacyandTherapeuticscommittee;and
 overseecompliancewithFederalPharmacyandTherapeutics
committeeconflict-of-interestrequirementsandguidance.
CMSshouldexploremethodstodevelopandimplementamechanism MEDICBenefitIntegrityActivitiesin
torecoverpaymentsfromPartCandPartDplansponsorswhenlaw MedicarePartsCandD,
enforcementagenciesdonotacceptcasesforfurtheractioninvolving OEI-03-11-00310(January2013)
inappropriateservices.
CMSshouldexcludeScheduleIIrefillswhencalculatingpaymentsto InappropriateMedicarePartD
sponsors. PaymentsforScheduleIIDrugsBilled
asRefills,OEI-02-09-00605
(September2012)
CMSshouldholdsponsorsmoreaccountableforinaccuraciesinthe MedicarePartDReconciliation
bids. Paymentsfor2006and2007,
OEI-02-08-00460(September2009)
CMSshouldusethisrequiredinformationtohelpdeterminethe MedicareDrugPlanSponsors
effectivenessofsponsorsfraudandabuseprograms. IdentificationofPotentialFraudand
Abuse,OEI-03-07-00380(October
2008)
58 CMSMedicaid
Recommendation RelevantReport(s)
Top25Recommendation#13 MoreThanOne-ThirdofMedicaid-
EnrolledChildreninFiveStatesDid
CMSshould: NotReceiveRequiredBloodLead
 monitornationalEPSDTperformancedataforbloodlead ScreeningTests,OEI-07-18-00371
screeningtestsandtargeteffortstowardlow-performing (October2021)
Statestodevelopactionplansforincreasingtests,according
toMedicaidsschedule;
 ensureconsistencyacrossCMSguidancerelatedto
actionablebloodleadreferencevaluesandbloodlead
screeningtestdefinitions;and
 coordinatewithpartnerstodevelopanddisseminateto
StateMedicaidagencieseducationalmaterialsthatreaffirm
requirementsandschedulesforbloodleadscreeningtests.
Top25Recommendation#16 OpportunitiesExistToStrengthen
EvaluationandOversightof
CMSshould:
TelehealthforBehavioralHealthin
 ensurethatthethreeStatesthatareunabletodistinguish
Medicaid,OEI-02-19-00401
telehealthfromin-personservicesimplementindicatorsto
(September2021)
identifywhichservicesareprovidedviatelehealth;
 conductevaluationsandsupportStateeffortstoevaluate
theeffectsoftelehealthonaccess,cost,andqualityof
behavioralhealthservices;and
 conductmonitoringforfraud,waste,andabuse,and
supportStateeffortstooverseetelehealthforbehavioral
healthservices.
Top25Recommendation#16 StatesReportedMultipleChallenges
WithUsingTelehealthToProvide
CMSshouldshareinformationtohelpStatesaddresschallengeswith
BehavioralHealthServicesto
usingtelehealthtoprovidebehavioralhealthservicestoMedicaid
MedicaidEnrollees,OEI-02-19-00400
enrollees.
(September2021)
Top25Recommendation#12 DataonMedicaidManagedCare
PaymentstoProvidersAreIncomplete
WithrespecttodataonMedicaidmanagedcarepayments,CMS andInaccurate,OEI-02-19-00180
should: (March2021)
 reviewStatesmanagedcarepaymentdatainT-MSISand
ensurethatStateshavecorrectiveactionplanstoimprove
datacompletenessandquality,asappropriate;
 makepublicitsreviewsofStatesmanagedcarepayment
data;and
 clarifyandexpanditsinitiativeonpaymentdata,andmake
publicitsreviewsofStatesmanagedcarepaymentdata.
59 Recommendation RelevantReport(s)
Top25Recommendation#1 MedicaidDataCanBeUsedToIdentify
InstancesofPotentialChildAbuseor
Withrespecttoidentifyingpotentialchildabuseandneglect,CMS Neglect,A-01-19-00001(July2020)
shouldissueguidance,suchasanInformationalBulletin,toinform
StatesthatperformingadataanalysistoidentifyMedicaidclaims
containingoneormorediagnosiscodesindicatingpotentialchild
abuseorneglectcouldhelpidentifyincidentsofpotentialchildabuse
orneglectandhelpensurecompliancewiththeStatesmandatory
reportinglaws.
CMSshould: StatesCouldDoMoreToOversee
 collaboratewithStatestoconductgreateroversightof SpendingandContainMedicaid
MedicaidMCOsmanagementofspecialtydrugs,andthis CostsforSpecialtyDrugs,
oversightcouldincludeareviewofcontractlanguagethat OEI-03-17-00430(December2020)
allowsStatestoobtainrequestedinformationonspecialty
drugcategorizations,specialtydrugreimbursement
methodologies,andcostmanagementstrategies;
 provideStateswithacquisitioncostdataforawiderrangeof
specialtydrugs;and
 workwithStatestoexpandalternativereimbursement
modelstoaddressrisingcostsfordrugsoftencategorizedas
specialtydrugs.
CMSshouldrequirethatparticipatingStatesconsistentlysubmitdata NationalBackgroundCheckProgram
thatallowforCMSandeachStatetocalculatedeterminationsof forLong-Term-CareProviders:
ineligibility. AssessmentofStatePrograms
Concludedin2019,OEI-07-20-00180
(September2020)
CMSshouldverifythatallStateplanscomplywithFederal CMSCouldTakeActionsToHelp
requirementsprohibitingpaymentsforprovider-preventable StatesComplyWithFederal
conditionsandissueclarifyingguidancetoStatesinspecificareas RequirementsProhibitingMedicaid
(e.g.,tohelpensurethatStatesidentifyprovider-preventable PaymentsforInpatientHospital
conditionsoninpatientclaimsfromallinpatienthospitals). ServicesRelatedtoProvider-
PreventableConditions,
A-09-18-02004(March2020)
Top25Recommendation#12 StatesCouldDoMoreToPrevent
TerminatedProvidersFromServing
Withrespecttopreventingterminatedprovidersfromserving MedicaidBeneficiaries,
Medicaidbeneficiaries,CMSshould: OEI-03-19-00070(March2020)
 recoverfromStatestheFederalshareofinappropriatefee-
for-serviceMedicaid payments associatedwith terminated
providers,
 implementamethodtorecoverfromStatestheFederalshare
ofinappropriatemanagedcarecapitationpayments
associatedwithterminatedproviders,and
60 Recommendation RelevantReport(s)
 safeguardMedicaidfrominappropriatepaymentsassociated
withterminatedproviders.
CMSshould: Twenty-ThreeStatesReported
 takestepstodisallowFederalreimbursementstoStatesfor AllowingUnenrolledProvidersTo
expendituresassociatedwithunenrolledMCOnetwork ServeMedicaidBeneficiaries,
providers,includingseekingnecessarylegislativeauthority; OEI-05-19-00060(March2020)
 workwithStatestoensurethatunenrolledprovidersdonot
participateinMedicaidmanagedcareandassistStatesin
establishingwaystodoso;
 workwithStatestoensurethattheyhavethecontrols
requiredtopreventunenrolledordering,referring,or
prescribingprovidersfromparticipatinginMedicaidfee-for-
service;and
 workwithStatestoensurethattheyarecomplyingwith
requirementstocollectidentifyinginformationandownership
informationonMedicaidproviderenrollmentforms.
Top25Recommendation#16 ProviderShortagesandLimited
AvailabilityofBehavioralHealth
WithrespecttoavailabilityofMedicaidbehavioralhealthservices, ServicesinNewMexicosMedicaid
CMSshouldidentifyStateswithlimitedavailabilityofbehavioral ManagedCare,
healthservicesanddevelopstrategiesandshareinformationto OEI-02-17-00490(September2019)
ensurethatMedicaidmanagedcareenrolleeshavetimelyaccessto
theseservices.
CMSshouldimplementasystemtoshareresponsestomanufacturer ReasonableAssumptionsin
inquiriesfortechnicalassistance. ManufacturerReportingofAverage
ManufacturerPricesandBestPrices,
OEI-12-17-00130(September2019)
Top25Recommendation#12 NationalReviewofOpioidPrescribing
inMedicaidIsNotYetPossible,
WithrespecttoopioidprescribinginMedicaid,CMSshouldensure OEI-05-18-00480(August2019)
thecorrectsubmissionofprescriberNationalProviderIdentifiers.
CMSshouldanalyzetheeffectivenessofstrategiesforimprovingrates ManyMedicaid-EnrolledChildren
offollowupcareforchildrentreatedforAttentionDeficit WhoWereTreatedforADHDDidNot
HyperactivityDisorder. ReceiveRecommendedFollowupCare,
OEI-07-17-00170(August2019)
CMSshould: ProblemsRemainforEnsuringAll
 amenditsguidancesothatStatescannotforegoconducting High-RiskMedicaidProvidersUndergo
criminalbackgroundchecksonhigh-riskprovidersapplyingfor CriminalBackgroundChecks,
MedicaidthathavealreadyenrolledinMedicareunless OEI-05-18-00070(July2019)
Medicarehasconductedthechecks,and
 comparehigh-riskMedicaidprovidersself-reported
ownershipinformationtoMedicaresproviderownership
informationtohelpStatesidentifydiscrepancies.
61 Recommendation RelevantReport(s)
CMSshouldworkwithStatestorecoupanypotentiallyinappropriate OnePercentofDrugsWithMedicaid
FederalreimbursementfordrugsthatCMSdetermineswerenotFDA- ReimbursementWereNotFDA-
approvedanddidnotmeetthecriteriaforanexception. Approved,
OEI-03-17-00120(May2019)
CMSshould: FourStatesDidNotComplyWith
 workwiththeStatesreviewedtoensurethattheinstancesof FederalWaiverandState
noncompliancewithhealthandsafetyandadministrative RequirementsinOverseeingAdultDay
requirementsidentifiedinthisreportarecorrected; CareCentersandFosterCareHomes,
 assistallStatestoensurethehealthandsafetyofvulnerable A-05-19-00005(May2019)
adultsbyofferingtechnicalassistancetolookatstaffing
modelsincenters,homes,andotherhomeandcommunity-
basedservicesettings;and
 assistallStatestoensurethehealthandsafetyofvulnerable
adultsbyofferingtechnicalassistancetolookatpossible
templatesforadministrativerecordsincenters,homes,and
otherhomeandcommunity-basedservicesettings.
CMSshould: CMSGuidancetoStateSurvey
 reconsideritspositiononpermittingStateagenciestocertify AgenciesonVerifyingCorrectionof
nursinghomessubstantialcomplianceonthebasisof DeficienciesNeedsToBeImprovedTo
correctionplanswithoutobtainingevidenceofcorrectionfor HelpEnsuretheHealthandSafetyof
lessseriousdeficiencies(deficiencieswithratingsofD,E,and NursingHomeResidents,
Fwithoutsubstandardqualityofcare); A-09-18-02000(February2019)
 reviseguidancetoStateagenciestoprovidespecific
informationonhowStateagenciesshouldverifyand
documenttheirverificationsofnursinghomescorrectionsof
lessseriousdeficienciesbeforecertifyingnursinghomes
substantialcompliancewithFederalparticipation
requirements;
 reviseguidancetoStateagenciestoclarifythetypeof
supportingevidenceofcorrectionthatshouldbeprovidedby
nursinghomeswithorinadditiontocorrectionplans;
 strengthenguidancetoStateagenciestoclarifywhomust
attestthatacorrectionplanwillbeimplementedbyanursing
home;
 considerimprovingitsformsrelatedtothesurveyand
certificationprocess,suchastheFormsCMS-2567,
CMS-2567B,andCMS-1539,sothatsurveyorscanexplicitly
indicatehowaStateagencyverifiedcorrectionofdeficiencies
andwhatevidencewasreviewed;and
 workwithStateagenciestoaddresstechnicalissueswiththe
automatedsurveyprocessingenvironmentsystemfor
maintainingsupportingdocumentation.
62 Recommendation RelevantReport(s)
CMSshould: AlthoughtheCentersforMedicare
 continuetofollowitspoliciesandproceduresrelatedtothe andMedicaidServicesHasMade
auditresolutionprocessandenhancethemwherepossibleto Progress,ItDidNotAlwaysResolve
ensurethatallmanagementdecisionsareissuedwithinthe AuditRecommendationsin
required6-monthresolutionperiod;and AccordanceWithFederal
 promptlyresolvethe140outstandingauditrecommendations Requirements,A-07-18-03228
thatwerepastdueasofSeptember30,2016. (January2019)
CMSshouldinstructallStateagenciestoreview,revise,develop,and VulnerabilitiesExistinStateAgencies'
implementpoliciesandprocedurestomonitorschooldistrict UseofRandomMomentSamplingTo
administrativeclaimingandschool-basedhealthservicesprogramsin AllocateCostsforMedicaidSchool-
theirStates. BasedAdministrativeandHealth
ServicesExpenditures,
A-07-18-04107(December2018)
Top25Recommendation#14 TheCentersforMedicareand
MedicaidServicesHadNotRecovered
WithrespecttoidentifiedMedicaidoverpayments,CMSshould: MoreThanaBillionDollarsin
 recovertheremaining$1,644,235,438duetheFederal MedicaidOverpaymentsIdentifiedby
Governmentfromthecurrentperiod; OIGAudits,A-05-17-00013
 recovertheremaining$188,593,212duetheFederal (December2018)
Governmentfromthepriorperiod;
 developpoliciesandprocedurestoimprovethetimelinessof
recoveringoverpaymentswhenStatesdisagreewith
recommendationsbysettingguidelinesfortheamountof
timeCMShasto:
o discusswithStateofficialsregardingtheaudit
findings,
o obtaindocumentationtosubstantiatetheStates
position,and
o issuethedisallowancelettertotheState;
 verifythatfutureoverpaymentrecoveriesarereported
correctlyonline10ofaCMS-64;
 requireStatestosubmitcorrectedCMS-64stoidentify
recoveredoverpaymentsonline10whendoneincorrectly;
and
 continuetoeducateStatesabouttheirresponsibilitytoreport
overpaymentsonthecorrectlineofaCMS-64toimprove
oversightofthereportingprocess.
CMSshouldreevaluatetheeffectsofthehealthcare-relatedtaxsafe- AlthoughHospitalTaxProgramsin
harborthresholdandtheassociated75/75requirementtodetermine SevenStatesCompliedWithHold-
whethermodificationsareneeded. HarmlessRequirements,theTax
BurdenonHospitalsWasSignificantly
Mitigated,
A-03-16-00202(November2018)
63 Recommendation RelevantReport(s)
Top25Recommendations#12and#15 WeaknessesExistinMedicaid
ManagedCareOrganizationsEfforts
WithrespecttoMedicaidMCOseffortstoidentifyandaddressfraud ToIdentifyandAddressFraudand
andabuse,CMSshould: Abuse,
 improvetheMCOidentificationandreferralofcasesof OEI-02-15-00260(July2018)
suspectedfraudorabuse;
 increasetheMCOreportingofcorrectiveactionstaken
againstproviderssuspectedoffraudorabusetotheState;
 identifyandsharebestpracticesaboutpaymentretention
policiesandincentivestoincreaserecoveries;
 improvecoordinationbetweenMCOsandotherState
programintegrityentities;
 standardizereportingofreferralsacrossallMCOsinaState;
 ensurethatMCOsprovidecomplete,accurate,andtimely
encounterdata;and
 monitorencounterdataandimposepenaltiesonStatesfor
submittinginaccurateorincompleteencounterdata.
CMSshouldrequiretheuseofclaim-levelmethodstoidentify340B StateEffortsToExclude340BDrugs
claims. FromMedicaidManagedCare
Rebates,OEI-05-14-00430(June
2016)
CMSshouldrequireStateMedicaidprogramstoverifythe Medicaid:VulnerabilitiesRelatedto
completenessandaccuracyofproviderownershipinformation. ProviderEnrollmentandOwnership
Disclosure,
OEI-04-11-00590(May2016)
CMSshould: MedicaidEnhancedProvider
 developacentralsystembywhichStatescansubmitand EnrollmentScreeningsHaveNotBeen
accessscreeningresultsfromotherStates, FullyImplemented,
 strengthenminimumstandardsforfingerprint-basedcriminal OEI-05-13-00520(May2016)
backgroundchecksandsitevisits,and
 workwithStatestodevelopaplantocompletetheir
revalidationscreeninginatimelyway.
CMSshould: OpportunitiesforProgram
 issueguidancethatclarifiesrequirementsandprovides ImprovementsRelatedtoStates'
furtherinterpretationoftheasneededlanguagein WithdrawalsofFederalMedicaid
42CFR430.30(d)(3)asitrelatestothewithdrawalof Funds,A-06-14-00068(March2016)
Medicaidfunds;
 publishregulationsthatareconsistentwithDepartmentof
theTreasuryprovisionsin31CFRpart205andeducate
States;
64 Recommendation RelevantReport(s)
 publishandenforceformalguidancebasedonCMSs
instructionalemailfromNovember8,2011,sothatStatesare
awareoftheappropriatePaymentManagementSystem
accountfromwhichtowithdraworreturnfunds;and
 requireStatestoreconciletotalFederalMedicaidfunds
withdrawnwiththeFederalshareofnetexpendituresand
issueappropriatereconciliationguidelines.
CMSshould: MostChildrenWithMedicaidinFour
 developbenchmarksfordentalservicesandrequireStatesto StatesAreNotReceivingRequired
createmandatoryactionplanstomeetthem, DentalServices,
 workwithStatestoanalyzetheeffectsofMedicaidpayments OEI-02-14-00490(January2016)
onaccesstodentalproviders,and
 workwithStatestotrackchildrensutilizationofrequired
dentalservices.
CMSshouldissueMedicaidregulationstoclarifytherequirementsof ProvidersDidNotAlwaysReconcile
theAffordableCareActthatparallelitsproposedMedicarerulesand PatientRecordsWithCreditBalances
requirethatStatesensurethatprovidersexercisereasonable andReportandReturntheAssociated
diligencetoidentify,report,andreturnoverpayments. MedicaidOverpaymentstoState
Agencies,A-04-14-04029(August
2015)
CMSshouldworkwithStatesto: AccesstoCare:ProviderAvailabilityin
 ensurethatplansarecomplyingwithStatestandardsand MedicaidManagedCare,
assesswhetheradditionalstandardsareneeded, OEI-02-13-00670
 ensurethatplansnetworksareadequateandmeettheneeds (December2014)
oftheirMedicaidmanagedcare enrollees,and
 assessthenumberofprovidersofferingappointmentsand
improvetheaccuracyofplaninformation.
CMSshould: StateStandardsforAccesstoCarein
 strengthenitsoversightofStatestandardsandensurethat MedicaidManagedCare,
Statesdevelopstandardsforkeyproviders, OEI-02-11-00320(September2014)
 strengthenitsoversightofStatesmethodstoassessplan
complianceandensurethatStatesconductdirecttestsof
accessstandards,and
 improveStateseffortstoidentifyandaddressviolationsof
accessstandards.
CMSshouldrequireatleastoneonsitevisitbeforeawaiverprogramis OversightofQualityofCarein
renewedanddevelopdetailedprotocolsforsuchvisits. MedicaidHomeandCommunity-
BasedServicesWaiverPrograms,
OEI-02-08-00170(June2012)
CMSshould: StatesCollectionofMedicaid
 takeactionagainstStatesthatdonotmeettheDeficit RebatesforPhysician-Administered
ReductionActof2005requirementtocollectrebateson Drugs,
physician-administereddrugsand OEI-03-09-00410(June2011)
65 Recommendation RelevantReport(s)
 ensurethatallStateagenciesareaccuratelyidentifyingand
collectingphysician-administereddrugrebatesowedby
manufacturers.
CMSshouldprovideStateswithdefinitiveguidanceforcalculatingthe ReviewofMedicaidEnhanced
Medicaidupperpaymentlimit,whichshouldincludeusingfacility- PaymentstoLocalPublicProviders
specificupperpaymentlimitsthatarebasedonactualcostreport andtheUseofIntergovernmental
data. Transfers,
A-03-00-00216(September2001)
EstimatedSavings:$3.87billionover5years
CMSGeneral
Recommendation RelevantReport(s)
CMSshould: CMSShouldTakeFurtherActionTo
 activelymonitortheuseandeffectivenessofStates AddressStatesWithPoor
correctiveactionplansandotherremedies,withafocuson PerformanceinConductingNursing
makingtheremediesspecificandoutcomeoriented; HomeSurveys,OEI-06-19-00460
 establishguidelinesforprogressiveenforcementactions, (January2022)
includingtheuseofsanctions,whenpersistentoregregious
performanceproblemsemerge;
 engagewithseniorStateofficialsearlierandmorefrequently
toaddressStateperformanceproblems;
 disseminateresultsofStateperformancereviewsmorewidely
toensurethatstakeholdersbecomeawareofproblems;and
 revisetheStateOperationsManualtoreflectcurrentCMS
practicesinoverseeingStatesurveyperformance.
Top25Recommendations#2 Facility-InitiatedDischargesinNursing
HomesRequireFurtherAttention,
CMSshould: OEI-01-18-00250(November2021)
 providetrainingfornursinghomesonFederalrequirements
forfacility-initiateddischargenotices;
 assesstheeffectivenessofitsenforcementofinappropriate
facility-initiateddischarges;
 implementitsdeferredinitiativestoaddressinappropriate
facility-initiateddischarge;
coordinatewithACLtostrengthensafeguardstoprotect
nursinghomeresidentsfrominappropriatefacility-initiated
discharges;and
 ensurethatallStateombudsmen,Stateagencies,andCMS
regionaloffices(ROs)haveanongoingvenuetoshare
informationaboutfacility-initiateddischargesandpotentially
othersystemicproblemsinnursinghomes.
66 Recommendation RelevantReport(s)
CMSshould: Summaryofrecommendationsfrom
 continuetoenhancethedataanalysisofMedicaidclaims- CMSFinancialReportFiscalYear
leveldatatodeveloprobustanalyticalproceduresand 2021,ReportontheFinancial
measuresagainstbenchmarksinordertomonitorand StatementAuditoftheCentersfor
identifyrisksassociatedwiththeMedicaidprogram; Medicare&MedicaidServicesfor
 establishaprocesstoperformaclaims-leveldetailedlook- FiscalYear2021,A-17-21-53000
backanalysisontheMedicaidEntitlementBenefitsDueand (November2021)
Payabletodeterminethereasonablenessofthemethodology
utilizedforrecordingtheapproximately$52.8billionaccrual;
 enhancethecontrolattributes,includingtheprecisionof
controls,aroundthecompletenessandaccuracyofunderlying
dataasitrelatestotheMedicaidSPAcontingencies,and
re-evaluatetheresponsiblepartiesbestsuitedtoreviewthe
accrualatthebalancesheetdateparticularlywhenthe
accrualchangesbetweenquartersexceedaspecifiedamount;
 continuetoadheretoestablishedpoliciesandproceduresto
ensurethattheStatementofSocialInsurancemodel
methodologyandrelatedcalculationandestimateare
reviewedatalevelofsufficientprecision;
 consideradditionalopportunitiestofurtherreduceimproper
paymentsthatareconsistentwiththeorganizationsobjective
ofimprovingpaymentaccuracylevels;
 continuetoimprovetheoperatingeffectivenessof
informationsecuritycontrolsincludingaccess;and
 continuallyassessthegovernanceandoversightacrossits
organizationalunitschargedwithresponsibilityforthe
informationsecurityofitsITsystemsanddata,atboth
headquartersandamongCMSMedicarefee-for-service
contractors.
CMSshould: CMSAuthorizedHundredsofMillions
 workwiththeTreasuryandQualifiedHealthPlan(QHP) ofDollarsinAdvancedPremiumTax
issuerstorecoverthe$43,455inimproperadvanced CreditsonBehalfofEnrolleesWhoDid
premiumtaxcredits(APTCs)identifiedinoursample,ortake NotMakeTheirRequiredPremium
otherremedialaction; Payments,A-02-19-02005(March
 workwiththeTreasuryandQHPissuerstorecoverthe 2021)
remainingimproperAPTCs,whichweestimatetobe
$950million,ortakeotherremedialactionforpoliciesfor
whichthepaymentswerenotallowable;and
 developaprocesstocollectfromQHPissuers:
o informationrelatedtoindividualspremiumpayments
paidduringthebenefityearand
o enrolleespolicyterminationinformationsothatCMS
canprovideaccurateenrollmentdatatotheIRS.
EstimatedSavings:$950millioninCY2018
67 Recommendation RelevantReport(s)
CMSshouldpursuestrategiestoincreasethenumberofat-risk CMSShouldPursueStrategiesTo
beneficiariesacquiringcommunity-useversionsofnaloxonethrough IncreasetheNumberofAt-Risk
Medicaid. BeneficiariesAcquiringNaloxone
ThroughMedicaid,
OEI-BL-18-00360(September2020)
CMSshould: CMSDidNotProvideEffective
 setfirmdeadlinesformarketplacestofullydevelopsystem OversightToEnsureThatState
functionalityforverifyingapplicantseligibilityandresolving MarketplacesAlwaysProperly
inconsistencies,assesspotentialenforcementmechanisms DeterminedIndividualsEligibilityfor
thatwouldensurethatmarketplacesmeetthosedeadlines, QualifiedHealthPlansandInsurance
andseeklegislativeauthoritytoestablishmechanismsthat AffordabilityPrograms,
areidentified; A-09-16-01002(September2017)
 continuetoworkwithmarketplacestodevelopthereporting
capabilitytoensurethatallrequireddataelementsinthe
QuarterlyMetricsReportsaresubmitted;and
 requiremarketplacestosubmitadditionaldataelements
relatedto:(1)averagelengthoftimetoresolve
inconsistencies,(2)numberofunresolvedinconsistencies,
and(3)numberofapplicantsforwhomthemarketplace
receivedafailuretofileandreconcileresponsecodefromthe
IRSandwhoweredeterminedeligibleforinsurance
affordabilityprograms.
CMSshouldassistIHSinitsoversighteffortsbyconductingmore IndianHealthServiceHospitals:More
frequentsurveysofhospitals,informingIHSleadershipofdeficiency MonitoringNeededToEnsureQuality
citations,andcontinuingtoprovidetechnicalassistanceandtraining. Care,OEI-06-14-00010(October
2016)
Administration forChildrenand Families(ACF)
Recommendation RelevantReport(s)
ACFshould: ACFCannotEnsureThatAllChild
 proactivelyprovidetechnicalassistancetoStatesthatface VictimsofAbuseandNeglectHave
challengesinappointingaguardianadlitemforeverychild CourtRepresentation,
victimand OEI-12-16-00120(March2021)
 proactivelyidentifyandaddressobstaclesthatStatesfacein
reportingcompleteandaccurateguardianadlitemdata.
Top25Recommendation#18 TheOfficeofRefugeeResettlement's
IncidentReportingSystemIsNot
Withrespecttoitsincidentreportingsystems,ORRshould: EffectivelyCapturingDataToAssistIts
 trackandtrendincidentreportinformationtobetter EffortsToEnsuretheSafetyofMinors
safeguardminorsinORRcare; inHHSCustody,
68 Recommendation RelevantReport(s)
 improveORRsguidancetofacilitiestohelpthemconsistently OEI-09-18-00430(June2020)
identifyandreportsignificantincidents;
 systematicallycollectkeyinformationaboutincidentsthat
allowsforefficientandeffectiveoversighttoensurethat
facilitiesaretakingappropriateactionstoprotectminors;and
 workwithcareproviderfacilitiestoaddressstaffingshortages
ofyouthcareworkersthatimpacttheabilitytoprevent,
detect,andreportincidents.
Top25Recommendation#18 UnaccompaniedAlienChildren
ProgramCareProviderFacilitiesDo
Withrespecttosecurity,ORRshouldconductareviewtodetermine NotIncludeAllRequiredSecurity
whethertoenhancerequiredphysicalsecuritymeasures. MeasuresinTheirChecklists,
OEI-05-19-00210(June2020)
Top25Recommendation#18 CommunicationandManagement
ChallengesImpededHHSsResponse
WithrespecttotheUnaccompaniedChildrenProgram,HHSshould: totheZero-TolerancePolicy,
 takestepstoensurethatchildrensinterestsareprioritized OEI-BL-18-00510(March2020)
andrepresentedindecisionsaffectingtheUnaccompanied
ChildrenProgram,both internally and when engaging with
interagencypartners;
 modifyorpursueformalagreementswiththeDepartmentof
HomelandSecurityandDepartmentofJusticetoensurethat
HHSisreceivinginformationthatsupportsitsoperatingofand
abilitytoprovidecareforchildrenintheUnaccompanied
ChildrenProgram;and
 furtherimproveitsabilitytoidentifyandtrackseparated
childrenbyreducingrelianceonmanualprocesses.
Top25Recommendation#17 CareProviderFacilitiesDescribed
ChallengesAddressingMentalHealth
WithrespecttothementalhealthneedsofchildreninHHScustody, NeedsofChildreninHHSCustody,
ACFsORRshould: OEI-09-18-00431(September2019)
 identifyanddisseminateevidence-basedapproachesto
addressingtraumainshort-termtherapy,
 developandimplementstrategiestoassistcareprovider
facilitiesinovercomingobstaclestohiringandretaining
qualifiedmentalhealthclinicians,
 assesswhethertoestablishmaximumcaseloadsforindividual
mentalhealthclinicians,
 helpcareproviderfacilitiesimprovetheiraccesstomental
healthspecialists,and
 takeallreasonablestepstominimizethetimethatchildren
remaininORRcustody.
69 Recommendation RelevantReport(s)
ACFshouldestablishaforumforStatestosharestrategiesregarding StatesPaymentRatesUndertheChild
howtheysetpaymentratestoensureequalaccessforeligiblefamilies CareandDevelopmentFundProgram
whilebalancingcompetingprogrampriorities. CouldLimitAccesstoChildCare
Providers,OEI-03-15-00170(August
2019)
Top25Recommendation#19 TreatmentPlanningandMedication
MonitoringWereLackingforChildren
Withrespecttochildreninfostercare,ACFshould: inFosterCareReceivingPsychotropic
 developacomprehensivestrategytoimproveStates Medication,OEI-07-15-00380
compliancewithrequirementsrelatedtotreatmentplanning (September2018)
andmedicationmonitoringforpsychotropicmedication,and
 helpStatesstrengthentheirrequirementsforoversightof
psychotropicmedicationbyincorporatingprofessional
practiceguidelinesformonitoringchildrenattheindividual
level.
ACFshouldexpandthescopeofChildandFamilyServicesReviewsto NotAllChildreninFosterCareWho
determinewhetherchildreninfostercarereceiverequiredhealth WereEnrolledinMedicaidReceived
screeningsaccordingtothetimeframesspecifiedinStatesplans. RequiredHealthScreenings,
OEI-07-13-00460(March2015)
AdministrationforCommunityLiving(ACL)
Recommendation RelevantReport(s)
Top25Recommendations#2 Facility-InitiatedDischargesin
NursingHomesRequireFurther
ACLshould: Attention,OEI-01-18-00250
 assistStateombudsmanprogramsinestablishingadata- (November2021)
collectionsystemforfacility-initiateddischargenotices;
 establishguidanceforanalysisandreportingofdatacollected
byStateombudsmanprogramsfromfacility-initiated
dischargenotices;
 coordinatewithCMStostrengthensafeguardstoprotect
nursinghomeresidentsfrominappropriatefacility-initiated
discharges;and
 ensurethatallStateombudsmen,Stateagencies,andCMS
ROshaveanongoingvenuetoshareinformationabout
facility-initiateddischargesandpotentiallyothersystemic
problemsinnursinghomes.
70 Food and Drug Administration (FDA)
Recommendation RelevantReport(s)
Top25Recommendation#22 FDAsRiskEvaluationandMitigation
Strategies:UncertainEffectivenessin
WithrespecttoREMS,FDAshould: AddressingtheOpioidCrisis,
 seekadditionalauthoritytoensurethatmanufacturersare OEI-01-17-00510(September2020)
heldaccountablewhenappropriate;
 enhanceitsREMSassessmentreviewprocess;
 strengthenREMSforopioidanalgesics(thesuccessorto
extended-releaseandlong-actingopioids)byrequiring
prescribertraining;and
 usethenewTIRFREMSpatientregistrytomonitorforknown
areasofrisk,suchasinappropriateconversionsandoff-label
prescribing.
FDAshould: FDA is IssuingMorePostmarketing
 buildcapacityintheDocumentArchiving,Reporting,and Requirements,butChallengesWith
RegulatoryTrackingSystemtosupportpostmarketing OversightPersist,OEI-01-14-00390
requirementsoversight;and (July2016)
 provideastandardizedformforannualstatusreports,ensure
thattheyarecomplete,andrequiresponsorstosubmitthem
electronically.
Top25Recommendation#22 FDALacksComprehensiveDataTo
DetermineWhetherRiskEvaluation
WithrespecttoREMS,FDAshouldensurethatassessmentreviewsare andMitigationStrategiesImprove
conductedinatimelymanner. DrugSafety,OEI-04-11-00510
(February2013)
FDAshouldseekstatutoryauthoritytoreviewsubstantiationfor DietarySupplements:
structure/functionclaimstodeterminewhetherclaimsaretruthful Structure/FunctionClaimsFailTo
andnotmisleading. MeetFederalRequirements,
OEI-01-11-00210(October2012)
FDAshouldseekstatutoryauthoritytoimposecivilmonetarypenalties DietarySupplements:CompaniesMay
oncompaniesthatdonotcomplywithregistrationrequirements. BeDifficultToLocateinan
Emergency,OEI-01-11-00211
(October2012)
FDAshouldconsiderseekingstatutoryauthoritytoimposecivil FDAInspectionsofDomesticFood
penaltiesthroughadministrativeproceedingsagainstfacilitiesthatdo Facilities,OEI-02-08-00080
notvoluntarilycomplywithstatutoryandregulatoryrequirements. (April2010)
HealthResourcesandServices Administration (HRSA)
Recommendation RelevantReport(s)
HRSAshouldshare340BceilingpriceswithStates. StateMedicaidPoliciesandOversight
ActivitiesRelatedto340B-Purchased
Drugs,OEI-05-09-00321(June2011)
71 Indian HealthService (IHS)
Recommendation RelevantReport(s)
Top25Recommendation#20 IndianHealthServiceUseofCritical
CareResponseTeamsHasHelpedTo
IHSshould: MeetFacilityNeedsDuringthe
 solicitfeedbackfromcriticalcareresponseteams(CCRTs) COVID-19Pandemic,
regardingtheirobservationsofpotentialneedforbroader, OEI-06-20-00700(September2021)
IHS-wideimprovements;
 compiletheCCRTsrecommendationstoindividualfacilities
andsharethemacrossallIHSandTribalfacilities;and
 assesswhetherIHScouldusetheCCRTmodeltoprovide
supportandtrainingtofacilitiesneedingassistancewithnon-
COVID-19-relatedcare.
IHSshould: FewPatientsReceivedHighAmounts
 assessthecostsandbenefitsofupdatingitselectronichealth ofOpioidsfromIHS-RunPharmacies,
record(EHR)systemwithtoolstosupportmoreautomated OEI-05-18-00470(December2020)
monitoringand
 requestsupportfromStatesandfromFederalpartnersto
addresschallengeswithState-runprescriptiondrug
monitoringprograms.
IHSshouldimplementqualityimprovementplanstoimprovepatient IncidenceofAdverseEventsinIndian
safetyacrossIHS,includingplansthatfocusspecificallyonsmaller HealthServiceHospitals,
hospitalsandpatientgroupsathigherriskofharm. OEI-06-17-00530(December2020)
IHSshould: IndianHealthServiceFacilitiesMade
 improvetheprocessforandtimelinessofconductingstaff ProgressIncorporatingPatient
ProtectionPolicies,butChallenges
backgroundinvestigations,andnotifyingfacilitieswhenstaff
Remain,
areapproved;
 provideadditionalguidanceandtrainingtofacilitieson OEI-06-19-00331(December2020)
patientprotectionpolicies,includingtheroleoflaw
enforcementandthereportingprocessrelatedtopatient
abuse;and
 establishandenforceadeadlinebywhichallfacilitiesmust
fullyincorporatethenewrequirementsintotheirpoliciesand
procedures,andactivelymonitorfacilityadherence.
IHSshould: InstancesofIHSLaborandDelivery
 encourageandsupportgreateradoptionoftheAlliancefor CareNotFollowingNationalClinical
InnovationonMaternalHealthsbundlesofmaternal-safety GuidelinesorBestPractices,
bestpractices; OEI-06-19-00190(December2020)
 takestepstoensurethatIHSprovidersemploybestpractices
indiagnosingandtreatingpostpartumhemorrhage;and
72 Recommendation RelevantReport(s)
 assessitslaboranddeliverypracticesandconsiderpractice
improvementsbasedonthefindingsofthisassessment.
Top25Recommendation#20 IndianHealthServiceHas
StrengthenedPatientProtection
IHSshould: PoliciesbutMustFullyIntegrateThem
 extendpoliciestoaddressmoretypesofperpetrators,victims, IntoPracticeandOrganizational
andabuse; Culture,
 ensurethatthenewincidentreportingsystemiseffectiveand OEI-06-19-00330(December2019)
addressestherisksidentifiedinthecurrentsystem;
 designateacentralowneratIHSheadquarterstoensureclear
rolesandresponsibilitiesforsharedownershipin
implementingpatientprotectionpolicies,andmanagingand
respondingtoabusereports;and
 continuetoactivelypromoteanorganizationalcultureof
transparencyandworktoresolvebarrierstostaffreportingof
abuse.
Top25Recommendation#20 RosebudHospital,IndianHealth
ServiceManagementofEmergency
WithrespecttoIHSoperatedhospitals,IHSshould: DepartmentClosureandReopening,A
 asamanagementpriority,developandimplementastaffing CaseStudy,OEI-06-17-00270
programforrecruiting,retaining,andtransitioningstaffand (July2019)
leadershiptoremotehospitals;
 enhancetrainingandorientationfornewhospitalleadersto
ensurethattheyfollowIHSdirectivesandcontinue
improvementefforts;and
 developproceduresfortemporaryemergencydepartment
closuresandcommunicatethoseprocedureswithreceiving
hospitalsandemergencymedicalservicestoensurethatthey
areadequatelypreparedtoreceivedivertedpatientsduring
suchevents.
IHSshouldworkwithhospitalsto: IHSNeedsToImproveOversightofIts
 developpoliciesandprocedurestoreviewEHRsofpatients HospitalsOpioidPrescribingand
withopioidprescriptionsfromnon-IHSprovidersand DispensingPracticesandConsider
documenttheresultsofthereviewintheEHR,particularlyfor CentralizingItsInformation
thosepatientswhohadpreviouslyviolatedtheirchronic TechnologyFunctions,A-18-17-11400
opioidtherapyagreements;and (July2019)
 trackallopioidsprescribedatthehospitalinthepatientEHRs,
includingthosebeingfilledatanoutsidepharmacy.
73 Recommendation RelevantReport(s)
IHSshould: IndianHealthServiceHospitals:More
 implementaquality-focusedcomplianceprogramtosupport MonitoringNeededToEnsureQuality
Federalrequirementsforhealthcareprograms; Care,OEI-06-14-00010(October
 continuetoinvestintrainingforhospitaladministrationand 2016)
staff,andassessthevalueandeffectivenessoftraining
efforts;
 establishstandardsandexpectationsforhowAreaOfficesand
GoverningBoardsoverseeandmonitorhospitalsandmonitor
adherencetothosestandards;and
 continuetoseeknew,meaningfulwaystomonitorhospital
qualitythroughtheuseofoutcomesand/orprocess
measures.
IHSshouldidentifyallhospitalswithunsupportednetworking TwoIHSHospitalsHadSystem
equipmentandimplementasystemdevelopmentlifecycleplanto SecurityandPhysicalControlsfor
ensurehardwareandsoftwarereplacementbeforeend-of-life. PrescriptionDrugandOpioid
DispensingButCouldStillImprove
Controls,A-18-16-30540(November
2017)
Top25Recommendation#20 IndianHealthServiceHospitals:
LongstandingChallengesWarrant
WithrespecttothequalityofcaredeliveredinIHShospitals,IHS FocusedAttentionToSupportQuality
shouldconductaneedsassessmentculminatinginanagencywide Care,OEI-06-14-00011(October
strategicplanwithactionableinitiativesandtargetdates. 2016)
NationalInstitutesofHealth(NIH)
Recommendation RelevantReport(s)
NIHshould: SelectedNIHInstitutesMet
 centrallycaptureandmonitordataonICsfundingofgrant RequirementsforDocumentingPeer
applicationsoutofrankorder;and ReviewButCouldDoMoreToTrack
 updateitspolicyandguidancetoreflectthelatestHHS andExplainFundingDecisions,
grantspolicyonjustifyingfundingoutofrankorder. OEI-01-19-00140(June2021)
Top25Recommendation#21 NIHHasActedToProtectConfidential
InformationHandledbyPeer
Withrespecttopeerreviewers,NIHshould: Reviewers,ButItCouldDoMore,
 conducttargeted,risk-basedoversightofpeerreviewersusing OEI-05-19-00240(March2020)
analysisofinformationaboutthreatstoresearchintegrity;
 updateitstrainingmaterialsroutinelytoincludeinformation
aboutbreachesofpeerreviewerconfidentialityandpossible
undueforeigninfluence;and
 requireallpeerreviewerstoattendperiodictrainingabout
peerreviewintegrity.
74 Recommendation RelevantReport(s)
Top25Recommendation#21 VettingPeerReviewersatNIHs
CenterforScientificReview:Strengths
Withrespecttovettingpeerreviewers,NIHshould: andLimitations,
 updateitsguidanceonvettingpeerreviewernomineesto OEI-01-19-00160(September2019)
identifypotentialforeignthreatstoresearchintegrity,in
consultationwithnationalsecurityexperts,asneeded;and
 workwiththeHHSOfficeofNationalSecuritytodevelopa
risk-basedapproachforidentifyingthosepeerreviewer
nomineeswhowarrantextrascrutiny.
NIHshouldpromulgateregulationsthataddressinstitutionalFCOIs. InstitutionalConflictsofInterestat
NIHGrantees,OEI-03-09-00480
(January2011)
GeneralDepartmental
Recommendation RelevantReport(s)
HHSshould: DepartmentofHealthandHuman
 continuetoworkwithOMBandotherstakeholdersto ServicesMetManyRequirements,but
developandimplementanapproachtoreportingon ItDidNotFullyComplyWiththe
TemporaryAssistanceforNeedyFamilies(TANF)improper PaymentIntegrityInformationActof
paymentsinFY2022,asthisprocesswillaidinidentifyingroot 2019andApplicableImproper
causesofTANFimproperpaymentsandallowHHStoreport PaymentGuidanceforFiscalYear
correctiveactionplans(CAPs)intheAgencyFinancialReport; 2021,A-17-22-52000(May2022)
 focusontherootcausesoftheimproperpaymentpercentage
andevaluatecriticalandfeasibleactionstepstoassistStates
withtheircomplianceeffortsforthesenewrequirements,
includingworkingwithStatestobringtheirrespective
systemsintofullcompliancewiththerequirementsto
decreasetheimproperpaymentratepercentagebelow
10percent,andHHSshouldworkwithStatestofollowupon
repeatrootcausesforerrorsandenhancetheCAPsfor
implementation;
 continuetofollowupwithStatesduringtheinterimperiodto
verifythatcorrectiveactionsidentifiedafteranimproper
PaymentErrorRateMeasurementreviewarebeing
implemented,andHHSshouldalsoconsidersharing
correctiveactionbestpracticesacrossStatestohelpaddress
theseissues;
75 Recommendation RelevantReport(s)
 improveitsrecoveryauditeffortsasrequiredunderthe
PaymentIntegrityInformationAct(PIIA)Section2(i),to
identifyandrecoupoverpaymentsforMedicarePartsCandD
unlessnotdeemedcost-effective,andHHSshouldalso
continuetoexplorealternativevehiclestoconductrecovery
auditsthatwillfitintothelargerMedicarePartsCandD
programsinFY2022intheeventthattheRiskAdjustment
DataValidationandPPI-MEDICprogramscannoteffectively
serveasHHSssolerecoveryauditstrategies;
 continuetoworkwithOMBandotherrelevantstakeholders
tocompletetheimproperpaymentmeasurementprogram
forthefederallyfacilitatedexchangeinFY2022,andHHS
continuestomakeprogressinthedevelopmentofan
improperpaymentmeasurementmethodologyfortheState-
basedexchangetoreportanaccurateimproperpayment
estimate;
 either(1)implementariskassessmentstrategythatensures
thatallprogramswithannualoutlaysgreaterthan$10million
arerisk-assessedatleastonceevery3years;or(2)workwith
OMBtodevelopanapproachandobtainconcurrenceto
performriskassessmentsatalevelthatmeetstheintentof
PIIA,asHHShas236programsthatexceedthe$10million
thresholdinFY2021andHHSshouldconsiderwhatadditional
resourcesareneededtoperformtheseriskassessmentsfor
anorganizationaslargeandcomplexasHHS,orwhat
enhancementscanbemadetothecurrentprocesstoreduce
thetimeandefforttoriskassesseachprogram;and
 focusontherootcausesoftheimproperpaymentpercentage
andevaluatecriticalandfeasibleactionstepstoassistMAOs
withcomplianceefforts,andthiswouldincludeworkingwith
theMAOsspecificallythosewithrepeatednoncompliance
toensurethatmedicalrecorddocumentationissufficientand
substantiatesclinicaldiagnoses,astheseeffortscouldreduce
medicalrecorddiscrepancies,whichwouldassistHHSinits
effortstodecreasetheimproperpaymentratepercentage
below10percent.
HHSshould: Summaryofrecommendationsfrom
 continuetodevelopandrefineitsfinancialmanagement OIGReportontheFinancialStatement
systemsandprocessestoimproveaccounting,analysis,and AuditofHHSforFiscalYear2021,
oversightoffinancialmanagementactivity;and A-17-21-00001(November2021)
 continuetostrengthenoversightofremediationactivitiesto
limitnewdeficienciesandimproveinternalcontrolover
financialinformationsystems.
76 Recommendation RelevantReport(s)
Top25Recommendation#24 CMSDidNotAdministerandManage
StrategicCommunicationsServices
Withrespecttocontractadministrationandmanagement,HHS ContractsinAccordanceWithFederal
should: Requirements,
 determinewhetheranyHHScontractorsorsubcontractors A-12-19-20003(July2020)
areperforminginherentlygovernmentalfunctionsand
whetheranyactiveCMSservicecontractsortaskordersare
beingadministeredaspersonalservicescontracts,andtake
actiontocorrecttheiradministration;and
 providetrainingtopoliticalappointeesandseniorleaders
relatedtopropercontractadministration.
Top25Recommendation#25 HHSShouldAddressGapsinIncident
ResponseCapabilitiesAcrossthe
HHSshouldensurethatincidentresponsecapabilitiesarefully Department,
implementedatallOpDivsandComponents. A-18-17-04002(May2020)
Top25Recommendation#23 SelectedHealthCareCoalitions
IncreasedInvolvementinWhole
WithrespecttoHCCs,ASPRshould: CommunityPreparednessButFace
 clarifyHospitalPreparednessProgramguidancethatHCC DevelopmentalChallengesFollowing
membershipshouldensurestrategic,comprehensivecoverage NewRequirementsin2017,
ofcommunitygapsinpreparednessandresponse; OEI-04-18-00080(April2020)
 continuetoworkwithCMStohelphealthcareentitiescomply
withtheCMSemergencypreparednessCoPs;
 identifywaystoincentivizecorememberparticipationin
HCCs;and
 clarifytoHPPawardeestheflexibilityavailableinmeeting
cooperativeagreementrequirements.
Top25Recommendation#23 HHSDidNotAlwaysEfficientlyPlan
andCoordinateItsInternationalEbola
Withrespecttoemergencyresponse,HHSshould: ResponseEfforts,A-04-16-03567
 developdepartmentwideobjectivesandastrategic (August2019)
frameworkforrespondingtointernationalpublichealth
emergencies;
 developpoliciesandproceduresthatclearlydefineHHS
componentsrolesandresponsibilitiesforrespondingto
internationalpublichealthemergencies;
 developlarge-scaleinternationalresponseplans;
 developvariousmeansofobtainingandusingqualitydatafor
decision-making;and
 workwithotherFederalGovernmentagenciestodevelopa
flexible,multiagencyinternationalresponseframework.
77 Recommendation RelevantReport(s)
Withrespecttosecurity,HHSshouldensurethat: SummaryReportforOfficeof
 OpDivsimplementproperlyconfiguredwebapplication InspectorGeneralPenetrationTesting
firewallsinaccordancewithanagreed-uponbaseline ofEightHHSOperatingDivision
standardestablishedbyHHS. Networks,A-18-18-08500(March
2019)
HHSshouldaddressfactorsthatmaylimittheOfficeforHuman OHRPGenerallyConductedIts
ResearchProtectionsabilitytooperateindependently. ComplianceActivitiesIndependently,
ButChangesWouldStrengthenIts
Independence,OEI-01-15-00350
(July2017)
HHSshouldreviseitsguidancetoincludespecificstandardsfor FederalMarketplace:Inadequaciesin
conductingpastperformancereviewsofcompaniesunder ContractPlanningandProcurement,
considerationduringcontractprocurement. OEI-03-14-00230(January2015)
ASFRshould: VulnerabilitiesintheHHSSmall
 ensurecompliancewithSmallBusinessInnovationResearch BusinessInnovationResearch
Programeligibilityrequirementsand Program,OEI-04-11-00530(April
 improveprocedurestocheckforduplicativeawards. 2014)
TheOfficeoftheNationalCoordinatorforHealthInformation NotAllRecommendedFraud
TechnologyandCMSshouldstrengthencollaborativeeffortsto SafeguardsHaveBeenImplemented
developacomprehensiveplantoaddressfraudvulnerabilitiesin Technology,OEI-01-11-00570
EHRs. (December2013)
78 Appendix C: Implemented and Closed
Recommendations Reported in 2021 Edition
Thisappendixidentifies72significantrecommendationsdescribedinthe2021editionofthispublication
thatwereimplementedorclosedsincetheeditionwasissued.13 OIGmayclosearecommendationthat
wasnotimplementedforarangeofreasons;forexample,theunderlyingproblemmayhavebeensolved
inadifferentway,aprogramchangemaymakearecommendationnolongerrelevant,orOIGmay
conductnewworkonthesameissueandmakeanew,supersedingrecommendationtoaddressthe
problem. TherecommendationslistedbelowaregenerallygroupedbyOpDiv. Wehaveindicatedwhich
recommendationsbelowwerelistedasrelevantforreportingonthe2021top25list. Thestatusofeach
recommendationisalsoincluded. Eachhyperlinkbelowprovidesmoreinformationonthereport
relevanttoeachrecommendation.
CMSMedicare Parts A and B
Status
Recommendation RelevantReport(s)
CMSshouldidentifyanyclaimsfortransfers MedicareImproperlyPaidAcute- Implemented
topost-acute-carehospitalsinwhich CareHospitals$54.4Millionfor
incorrectpatientdischargestatuscodeswere InpatientClaimsSubjecttothePost-
usedanddirecttheMedicarecontractorsto Acute-CareTransferPolicy,
recoveranyoverpaymentsafterouraudit A-09-19-03007(November2019)
period.
CMSshouldinstructDMEMACsto: MedicareImproperlyPaid Implemented/Closed
 recover $36,825 in overpayments SuppliersanEstimated$92.5
MillionforInhalationDrugs,
forthe39unallowableclaimlines;
A-09-18-03018(October2019)
and
 notifythe22suppliersassociated
withthe39claimlineswithpotential
overpaymentsof$36,825sothat
thosesupplierscanexercise
reasonablediligencetoinvestigate
andreturnanyidentified
overpayments,inaccordancewith
the60-dayrule,andidentifyand
trackanyreturnedoverpaymentsas
havingbeenmadeinaccordance
withthisrecommendation.
CMSshould: ACOsStrategiesforTransitioning Implemented
 reviewtheimpactofprogrammatic toValue-BasedCare:LessonsFrom
changesontheabilityofAccountable theMedicareSharedSavings
CareOrganizationstopromotevalue- Program,OEI-02-15-00451(July
basedcare, 2019)
13OIG,2021OIGsTopUnimplementedRecommendations:SolutionsToReduceFraud,Waste,andAbuseinHHSPrograms,Oct.
2021. Availableathttps://oig.hhs.gov/reports-and-publications/compendium/files/compendium2021.pdf.
79 Status
Recommendation RelevantReport(s)
 adoptoutcome-basedmeasuresand
betteralignmeasuresacross
programs,and
 identifyandshareinformationabout
strategiesthatencouragepatientsto
sharebehavioralhealthdata.
CMSshouldeducatehospicesaboutcommon HospiceDeficienciesPoseRisksto Implemented
deficienciesandthosethatposeparticular MedicareBeneficiaries,
riskstobeneficiaries. OEI-02-17-00020(July2019)
CMSshouldassessthecostsandbenefitsof CMSDidNotDetectSome Implemented
improvingoversightofno-paymentbills InappropriateClaimsforDurable
submittedbySNFs. MedicalEquipmentinNursing
Facilities,OEI-06-16-00380(June
2018)
CMSshouldseekalegislativechangethat ExcludingNoncoveredVersions Closed
wouldprovidetheagencyflexibilityto WhenSettingPaymentforTwo
determinewhennoncoveredversionsofa PartBDrugsWouldHaveResulted
drugshouldbeincludedinPartBpayment inLowerDrugCostsforMedicare
amountcalculations. anditsBeneficiaries,
OEI-12-17-00260
(November2017)
CMSshouldreviseandclarifysitevisitforms EnhancedEnrollmentScreeningof Implemented
sothattheycanbemoreeasilyusedby MedicareProviders:Early
inspectorstodeterminewhetherafacilityis ImplementationResults,
operational. OEI-03-13-00050(April2016)
CMSshouldseeklegislativeauthorityto MedicareandBeneficiariesCould Closed
expandtheDRGwindowtoincludeother RealizeSubstantialSavingsIfthe
hospitalownershiparrangements,suchas DRGWindowWereExpanded,
affiliatedhospitalgroups. OEI-05-12-00480(February2014)
CMSshouldlowerthefeescheduleamount MedicareSupplierAcquisitionCosts Implemented
fortheL0631backorthosis. forL0631BackOrthoses,
OEI-03-11-00600(December2012)
CMSshouldrevisetherequirementsinthe QuestionableBillingby Closed
localcoveragedetermination. SuppliersofLowerLimb
Prostheses,OEI-02-10-00170
(August2011)
CMSshouldrequirethatPSCs,ZPICs,and CollectionStatusof Implemented
claimsprocessorshavecontrolsintheir MedicareOverpayments
trackingsystemstoensurethatall IdentifiedbyProgram
overpaymentreferralsanddatarelatedto SafeguardContractors,
theircollectionstatuscanbefound. OEI-03-08-00030(May2010)
80 CMSMedicare Parts C and D
Status
Recommendation RelevantReport(s)
2021Top25Recommendation#9 MedicarePartDBeneficiariesat Implemented
Serious Risk of Opioid Misuse or
Withrespecttobeneficiariesreceiving Overdose:ACloserLook,
treatmentforopioidusedisorder,CMS OEI-02-19-00130(May2020)
shouldeducatePartDbeneficiariesabout
accesstomedicationassisteddrugsand
naloxone.
CMSshouldprovidetargetedoversightof BillionsinEstimatedMedicare Implemented
MAOsthathadrisk-adjustedpayments AdvantagePaymentsFromChart
resultingfromunlinkedchartreviewsfor ReviewsRaiseConcerns,
beneficiarieswhohadnoservicerecordsin OEI-03-17-00470(December2019)
the2016encounterdata.
2021Top25Recommendation#11 MedicareAdvantageEncounter Implemented
DataShowPromiseforProgram
CMSshould: Oversight,ButImprovementsAre
 establishandmonitorMedicare Needed,OEI-03-15-00060(January
2018)
Advantageencounterdata
performancethresholdsrelatedto
eachMAO'ssubmissionofrecords
withcompleteandvaliddata,
 providetargetedoversightofMAOs
thatsubmittedahigherpercentage
ofencounterrecordswithpotential
errors.
CMSshouldrecoup$26millioninimproper MedicareImproperlyPaidMedicare Closed
paymentsinaccordancewith AdvantageOrganizationsMillions
ofDollarsforUnlawfullyPresent
legalrequirements.
Beneficiariesfor2010Through
2012,A-07-13-01125(April2014)
CMSshoulddeterminewhetherthePartD MedicareDrugPlanSponsors Closed
sponsorsthatidentifiedfraudandabuse IdentificationofPotentialFraudand
initiatedinquiriesandcorrectiveactionsas Abuse,OEI-03-07-00380(October
requiredbyCMSandmadereferralsfor 2008)
furtherinvestigationasrecommendedby
CMS.
81 CMSMedicaid
Status
Recommendation RelevantReport(s)
CMS should assist participating States in NationalBackgroundCheck Implemented
addressingthechallengeofcoordination ProgramforLong-Term-Care
betweenState-leveldepartments. Providers:AssessmentofState
ProgramsConcludedin2019,
OEI-07-20-00180(September
2020)
2021Top25Recommendation#13 StatesCouldDoMoreToPrevent Implemented
TerminatedProvidersFromServing
Withrespecttopreventingterminated MedicaidBeneficiaries,
providersfromservingMedicaid OEI-03-19-00070(March2020)
beneficiaries,CMSshould:
 followupwithStatestoremove
terminatedprovidersthatOIG
identifiedasinappropriatelyenrolled
inMedicaid,and
 confirmthatStatesdonotcontinue
tohaveterminatedprovidersenrolled
intheirMedicaidprograms,and
 reviewStatescontractswithMCOs
toensurethattheyspecifically
includetherequiredprovisionthat
prohibitsterminatedprovidersfrom
participatinginMedicaidmanaged
carenetworks.
CMSshould: ReasonableAssumptionsin Implemented
 assessthecostsandbenefitsof ManufacturerReportingofAMPs
implementingatargetedprocessto andBestPrices,OEI-12-17-00130
reviewcertainassumptions;and (September2019)
 issueguidancerelatedtotheareas
identifiedinthereport,specifically
value-basedpurchasing
arrangements.
2021Top25Recommendations#13 NationalReviewofOpioid Implemented
PrescribinginMedicaidIsNotYet
Withrespecttoopioidprescribingin Possible,OEI-05-18-00480(August
Medicaid,CMSshouldworktoensurethat 2019)
individualbeneficiariescanbeuniquely
identifiedatanationallevelusingT-MSIS.
82 Status
Recommendation RelevantReport(s)
CMSshouldensurethatallStatesfully ProblemsRemainforEnsuringThat Implemented
implementfingerprint-basedcriminal AllHigh-RiskMedicaidProviders
backgroundchecksforhigh-riskMedicaid UndergoCriminalBackground
providers. Checks,OEI-05-18-00070
(July2019)
2021Top25Recommendations#13and#15 Weaknesses Exist in Medicaid Implemented
Managed Care Organizations
CMSshouldworkwithStatestoclarifythe EffortsToIdentifyandAddress
informationmanagedcareorganizationsare FraudandAbuse,
requiredtoreportregardingproviderswho OEI-02-15-00260(July2018)
areterminatedorotherwiseleavethe
managedcareorganizationnetwork.
CMSshouldassistStatesinimplementing MedicaidEnhancedProvider Implemented
fingerprint-basedcriminalbackgroundchecks EnrollmentScreeningsHaveNot
forallhigh-riskproviders. BeenFullyImplemented,
OEI-05-13-00520(May2016)
CMSshouldencourageStateMedicaid StateMedicaidProgramEffortsto Implemented
programstoseekfurthercostsavingsfor ControlCostsforDisposable
disposableincontinencesupplies. IncontinenceSupplies,
OEI-07-12-00710(January2014)
CMSGeneral
Status
Recommendation RelevantReport(s)
CMSshould: CMSDidNotAlwaysAccurately Implemented/Closed
 workwithTreasuryandQualified AuthorizeFinancialAssistance
PaymentstoQualifiedHealthPlan
HealthPlan(QHP)issuerstocollect
IssuersinAccordanceWithFederal
improperfinancialassistance
RequirementsDuringthe2014
payments,whichweestimatetobe
BenefitYear,A-02-15-02013
$434,398,168,forpoliciesforwhich
(August2018)
thepaymentswerenotauthorized
inaccordancewithFederal
requirementsandclarifyguidance
withQHPissuersonFederal
requirementsforterminatingan
enrolleescoveragewhenthe
enrolleefailstopaythemonthly
premium;and
83 Status
Recommendation RelevantReport(s)
 workwithTreasuryandQHPissuers
toresolvepotentiallyimproper
financialassistancepayments,
whichweestimatetobe
$504,889,518,forpoliciesforwhich
therewasnodocumentation
providedtoverifythatenrollees
hadpaidtheirpremiums.
CMSandtheOfficeofMedicareHearings ImprovementsAreNeededatthe Implemented
andAppealsshouldimprovethehandlingof AdministrativeLawJudgeLevelof
appealsfromappellantswhoarealsounder MedicareAppeals,OEI-02-10-00340
fraudinvestigationandseekstatutory (November2012)
authoritytopostponetheseappealswhen
necessary.
CMSshouldrequireallbenefitintegrity AddressingVulnerabilitiesReported Implemented
contractorstoreportmonetaryimpact,when byMedicareBenefitIntegrity
calculable,inaconsistentformat. Contractors,OEI-03-10-00500
(December2011)
Administration forChildren and Families (ACF)
Status
Recommendation RelevantReport(s)
Missourifostercareagencyshouldimplement CaseStudy:Missouri'sEffortsTo Implemented
improvementstothecasemanagement ProtectChildrenMissingFromFoster
systemtoenableaccurateidentificationof Care,OEI-07-19-00372(September
childrenwhoaremissingfromcare. 2021)
2021Top25Recommendations#17 TheOfficeofRefugeeResettlement Implemented
DidNotAwardandManagethe
HomesteadInfluxCareFacility
Withrespecttocontracts,ORRshould:
 ORRshouldestablishwritten ContractsinAccordanceWith
FederalRequirements,
policiesandproceduresfor
A-12-20-20001(December2020)
reviewinginvoices;
 establishapolicyandprocedurefor
protectingpublicfundswhenan
influxcarefacilityisnotfullystaffed
duetoareducednumberof
childrenatthefacility;
84 Status
Recommendation RelevantReport(s)
 workwithPSCtodocumentroles
andresponsibilitiesfordesignating
aContractingOfficer
Representative(COR)anddefining
contractsinaccordancewiththe
FederalAcquisitionRegulation
(FAR);
 workwithPSCtorecoupthe
$2,581,157overpaymentoffixed
feesfrom ComprehensiveHealth
Service,LLC.
 developplansforupcomingservice
needsbyusingallavailabledata
andindicatorstoensureadherence
toFARcompetitionrequirements;
and
 establishapolicyandprocedurefor
designatingemployeestoserveas
CORs.
2021Top25Recommendations#17 UnaccompaniedAlienChildren Implemented
ProgramCareProviderFacilitiesDo
Withrespecttosecurity,ORRshould: NotIncludeAllRequiredSecurity
 developandimplementmethodsto MeasuresinTheirChecklists,
ensurethatcareproviderfacilities OEI-05-19-00210(June2020)
regularlyreportinspectionchecklist
resultstoORR,and
 developandimplementmethodsto
ensurethatcareproviderfacilities
inspectionchecklistsincludeall
requiredphysicalsecuritymeasures.
2021Top25Recommendations#17 CommunicationandManagement Implemented
ChallengesImpededHHSsResponse
HHSshouldimprovecommunicationtocare totheZero-TolerancePolicy,
providerfacilitiesregardinginterimguidance, OEI-BL-18-00510(March2020)
operationaldirectives,andotherinstructions
thatarenotimmediatelyavailablein
publishedpolicydocuments.
2021Top25Recommendations#17 CareProviderFacilitiesDescribed Implemented
ChallengesAddressingMental
With respect to the mental health needs of HealthNeedsofChildreninHHS
children in HHS custody, ACFs ORR should Custody,OEI-09-18-00431
increase therapeutic placement options for (September2019)
childrenwhorequiremoreintensivemental
healthtreatment.
85 Status
Recommendation RelevantReport(s)
ACFshould: UnaccompaniedAlienChildrenCare Implemented
 reiteratetofacilitiesthatORR ProviderFacilitiesGenerally
ConductedRequiredBackground
requiresallbackgroundchecksbe
ChecksButFacedChallengesin
completedpriortoanemployees
Hiring,Screening,andRetaining
startdateandhavingaccessto
Employees,A-12-19-20001
children;
 requirefacilitiestoensurethat (September2019)
ChildProtectiveServices(CPS)
checksarecompletedforall
employeeswholivedoutsideofthe
currentStateofresidenceduring
theprevious5years,andwhere
necessaryORRshouldworkwith
facilitiestoensurethatCPSchecks
arecompleted;
 provideadditionalguidanceto
facilitiessotheycanbetterensure
thatcasemanagersandmental
healthcliniciansmeetORRs
minimumrequirededucation
qualifications;
 reiteratetoallfacilitiestheORR
policyrequiringthatfacilitiesobtain
ORRwrittenapprovalpriortohiring
acasemanagerormentalhealth
clinicianwhodoesnotmeet
minimumrequirementsandrequire
asupervisionplanoradditional
trainingforthepotentialemployee
asneeded;and
 workwithfacilitiestodevelopa
processforfacilitiestoreportwhen
casemanagerormentalhealth
clinicianstaffingratiosarenotmet
sothatORRcanusethis
informationwhenmaking
placementdecisionsandensuring
thatchildrensneedsaremet.
86 AgencyforHealthcareResearchand Quality(AHRQ)
Status
Recommendation RelevantReport(s)
AHRQshould: PatientSafetyOrganizations: Implemented
 takestepstoencourageparticipation HospitalParticipation,Value,and
bypatientsafetyorganizationsinthe Challenges,OEI-01-17-00420
NetworkofPatientSafetyDatabases, (September2019)
includingacceptingdataintothe
NetworkofPatientSafetyDatabases
inotherformatsinadditiontothe
commonformats;and
 updateguidanceforpatientsafety
organizationsontheinitialand
continuedlistingprocesses.
Food andDrug Administration (FDA)
Status
Recommendation RelevantReport(s)
FDAshouldprovideeducationaloutreachto OwnershipButNotPhysical Implemented
tradingpartnersaboutrequireddrug MovementofSelectedDrugs
producttracinginformationanddata CanBeTracedThroughtheSupply
standardizationguidelines. Chain,OEI-05-17-00460(February
2020)
FDAshould: TheFoodandDrugAdministrations Implemented
 developapolicyfordefininganda Food-RecallProcessDidNot
AlwaysEnsuretheSafetyofthe
procedureforidentifying
NationsFoodSupply,
retrospectivelythedatethatFDA
A-01-16-01502(December2017)
learnsofapotentiallyhazardous
productandconsideraddingafield
forthedatetotheRecallEnterprise
SystemoranotherFDAsystemso
thatFDAstaffinvolvedinmanaginga
recallhaveaccesstothis
information;and
 establishperformancemeasuresfor
theamountoftimebetweenthe
dateFDAlearnsofapotentially
hazardousproductandthedatea
firminitiatesavoluntaryrecall,
monitorperformance,andrefine
operatingprocedures,asneeded.
87 Status
Recommendation RelevantReport(s)
FDAshouldprovidetechnicalassistance DrugSupplyChainSecurity: Implemented
regardingexemptproducts. WholesalersExchangeMostTracing
Information,OEI-05-14-00640
(September2017)
FDAshouldrequirestandardizedelectronic ChallengesToFDAsAbilityTo Implemented
clinicaltrialdataandcreateaninternal MonitorAndInspectForeign
database. ClinicalTrialsOEI-01-08-00510
(June2010)
NationalInstitutesofHealth(NIH)
Status
Recommendation RelevantReport(s)
2021Top25Recommendations#20 TheNationalInstitutesofHealthHas Implemented
LimitedPolicies,Procedures,and
WithrespecttoFCOIcompliance,NIHshould ControlsinPlaceforHelpingTo
ensurethatthe1,013institutionsidentified EnsureThatInstitutionsReportAll
bythisreviewasnothavingFCOIpolicieson SourcesofResearchSupport,
theirwebsitespostthesepoliciesas FinancialInterests,andAffiliations,
required. A-03-19-03003(September2019)
2021Top25Recommendations#20 NIHHasMadeStridesinReviewing Closed
FinancialConflictsofInterestin
NIHshoulduseinformationregardingforeign ExtramuralResearch,ButCouldDo
affiliationsandsupportthatitcollectsduring More,OEI-03-19-00150(September
thepre-awardprocesstodecidewhetherto 2019)
reviseitsFCOIreviewprocesstoaddress
concernsregardingforeigninfluence.
NIHshoulddevelopdisseminateguidanceon HowGranteesManageFinancial Closed
methodstoverifyresearchersfinancial ConflictsofInterestinResearch
interests. FundedbytheNationalInstitutes
ofHealth,OEI-03-07-00700
(November2009)
Indian HealthService (IHS)
Status
Recommendation RelevantReport(s)
IHSshould: IncidenceofAdverseEventsin Implemented
 establishpatientharmmonitoring IndianHealthServiceHospitals,
andreductionasakeypriorityofthe OEI-06-17-00530(December2020)
OfficeofQuality,and
88 Status
Recommendation RelevantReport(s)
 effectivelytrackandmonitorpatient
harmeventsusinganimproved
incidentreportingsystem.
IHSshouldexamineandrevise,asneeded, IndianHealthServiceFacilities Implemented
thereportingstructureinthepoliciesand MadeProgressIncorporating
theincidentreportingsystemtoensurethat PatientProtectionPolicies,but
staffandpatientscanreportabuse ChallengesRemain,
anonymously. OEI-06-19-00331(December2020)
IHSshouldconductadditionaloutreachto IndianHealthServiceHas Implemented
Tribalcommunitiestoinformthemofpatient StrengthenedPatientProtection
rights,solicitcommunityconcerns,and PoliciesbutMustFullyIntegrate
addressbarrierstoreportingofpatientabuse. ThemIntoPracticeand
OrganizationalCulture,
OEI-06-19-00330(December2019)
2021Top25Recommendations#19 RosebudHospital,IndianHealth Implemented
ServiceManagementofEmergency
WithrespecttoIHSoperatedhospitals,IHS DepartmentClosureandReopening,
shouldcontinuetotakestepstoensureearly ACaseStudy,OEI-06-17-00270
andeffectiveinterventionwhenIHSidentifies (July2019)
problemsathospitals.
GeneralDepartmental
Status
Recommendation RelevantReport(s)
2021Top25Recommendations#23 CMSDidNotAdministerand Implemented
ManageStrategicCommunications
CMSshould: ServicesContractsinAccordance
 providetrainingtoprogramstaffand WithFederalRequirements,
contractingpersonnel,suchas A-12-19-20003(July2020)
contractingofficersandCORs,onFAR
requirementsspecifyingthat
contractsmustnotbeusedforthe
performanceofinherently
governmentalfunctionsandrelated
towrittenconsentfortheuseof
subcontractors;
89 Status
Recommendation RelevantReport(s)
 ensurethatcontractingpersonnel,
suchasacontractingofficer,review
contractsbeforebeingawardedto
determinewhetherlanguageis
includedthatcouldleadtothose
contractsbeingadministeredas
personalservicescontracts;
 ensurethatforallfuturecontracts,
CMSreceivesandaccepts
deliverablesinaccordancewiththe
StatementofWork(SOW),CORs
maintainworkingcontractfiles,and
CORsdocumentallchangesmadeto
theSOW;and
 expandtheCORInvoiceApproval
OperatingGuidancetoincludea
descriptionofacceptable
documentationtosupportcontractor
payments.
OHRPshouldrequestthatHHSconsiderthe OHRPShouldInformPotential Implemented
adequacyofwhistleblowerprotectionsfor ComplainantsofHowTheyCanSeek
complainantswhomakedisclosurestoOHRP WhistleblowerProtections,
abouthumansubjectsprotections. OEI-01-15-00351(September2017)
2021Top25Recommendations#24 SummaryReportforOfficeof Implemented
InspectorGeneralPenetration
Withrespecttosecurity,HHSshouldensure TestingofEightHHSOperating
thatallfuturewebapplicationdevelopments DivisionNetworks,
incorporatesecurityrequirementsfroman A-18-18-08500(March2019)
industry-recognizedwebapplicationsecurity
standard.
90 91