health standards section rural health clinics role ... · uthis presentation is set up to address...

HealthStandardsSection

RuralHealthClinics

Role&StructureofHealthStandardsSection

June25,2019

JennyHaines,RN,BSN

MedicalCertificationProgramManager

1

BeginnertoExpert

uThispresentationissetuptoaddressitemsthatrangeformbeginnerstoexpertsinnavigatingthelicensing&

certificationprocess.

u Ifyouareoneoftheexperts,pleasebepatientasweaddresssomeofthe

beginningprocesses.

2

Objectives

uDefinetherole&structureofHealthStandards

uExplaintheworkloadasitrelatestoRHCs

uExplainthelicensing&certificationprocessesforRHCs.

uProvideanoverviewofthetypesofsurveysandsurveyprocess.

3

CMS

TheSecretaryoftheDepartmentofHealthandHumanServices(DHHS)hasdesignatedCMStoadministertheMedicareandMedicaidprograms.

4

CMSCentralOffice

CMS’HealthStandards&QualityBureauisresponsiblefor:

u surveyandcertificationpolicies&procedures

u monitoringadherencetoprogramrequirements

u respondingtoquestions

u workingwithstatestoprovidejointoversightoftheMedicaidprogram

5

CMSRegionalOffice

uDetermineseligibilityforparticipationinMedicare

uWorkswithstateagenciestoevaluateperformance

uProvidestechnicalassistance

uAllocatesfundstostateagenciesforcertificationactivities

uPreparesandanalyzesCMSdata

uConductsFederalsurveys

6

CMSRegions

CMS Central Office in Baltimore

Region 1 Boston

Region 2 New York

Region 3 Washington

Region 4 Atlanta

Region 5 Chicago

Region 6 Dallas (LA, TX, NM, AR,

OK)

Region 7 Kansas City

Region 8 Denver

Region 9 San Francisco

Region 10 Seattle

7

Federal&StateRelationship

Section1864oftheSocialSecurityAct(theAct)establishestheframeworkwithinwhichStateAgencies(SAs),underagreementsbetweentheStateandtheSecretary,carryouttheMedicare

certificationprocess.

8

Federal&StateRelationship

StateAgency=LDHu DesignatedbytheGovernorasresponsibleforperformingthefunctionscreatedbySection1864oftheSocialSecurityAct.

u Responsibilitiesinclude:¡ certification/recertificationfunctions

¡ recordsmaintenance

¡ identifyingpotentialparticipantsinMedicare/Medicaid

¡ complaintinvestigations

¡ validationsurveys

¡ CLIAactivities

¡ licensingactivities.

9

HealthStandardsSection(HSS)

uAgencywithintheLouisianaDepartmentofHealth

uContractedbyCMStoperformthesurvey&certificationfunctionsinthestateofLouisiana

uEnforcesregulatorycomplianceforhealthcarefacilities

uReferredtoasthe“StateAgency”(SA)

10

HSSMission/Vision

MissionToenforceregulatorycomplianceforhealth

carefacilitiesintheStateofLouisiana

VisionThesectionwillberecognizedasaunitof

dedicatedhealthprofessionalswhoarefocusedonassuringallLouisianacitizens

receivegoodhealthservicesthatencouragebetterhealthandpromote

qualityoflife.

11

LDH&HSS

12

Office of The Secretary Secretary = Dr. Rebekah Gee

Office of Management & FinanceUndersecretary = Jeff Reynolds

Office of Management & FinanceDeputy Director = Michelle Aletto

Health StandardsDirector = Cecile Castello

HSSHospitalProgram

13

Director = Cecile Castello

Program Manager 2 NLTC = Dora Kane

Jennifer Haines(Hospital Program Manager)

• Short Term Acute Care Hospitals

• Critical Access Hospitals• Long Term Care Hospitals• Rehabilitation Hospitals• Psychiatric Hospitals• Children’s Hospitals• Medicaid Specialty Units• RHC off-site Campuses• Trauma Centers

New Program Manager(Hospital Program Manager) • Short Term Acute Care

Hospitals• Critical Access Hospitals• Long Term Care

Hospitals• Rehabilitation Hospitals• Psychiatric Hospitals• Children’s Hospitals• Medicaid Specialty Units• RHC off-site Campuses• Trauma Centers

Administrative Supervisor = Carla Jerome, Katri MartinAdministrative Assistant = Destinn O’Bear, Shelly Tyree, Tammy Walton

Program ManagerRHCs & FQHC

All certification action for RHCs

Licensing for Hospital RHCs

Certification for RHCsLicensing for Free Standing RHCs

RHC Program Manager

• Licensing of all independent free standing RHCs

HSS Field OfficesAs they relate to hospitals

HSS State Agency Field

Manager Darren Guillory

Field Office 1 New Orleans

& Thibodeaux Cherylann

Westerfield FOM

Field Office 2 Mandeville & Baton RougeBecky Knight

FOM

Title 18 Supervisor

Bill Whatley

Field Office 3 Lafayette Rita Simon

FOM

Field Office 4/5 Monroe & Shreveport

Clarice SteeleFOM

Field Office 6 Alexandria

Jackie Green FOM

14

*HSSFieldOfficeParishes*

Field Office 1 Field Office 2 Field Office 3

AscensionAssumption

IbervilleJeffersonLafourcheOrleans

PlaqueminesSt. BernardSt. CharlesSt. JamesSt. JohnSt. Mary

Terrebonne

East Baton RougeEast Feliciana

LivingstonPointe Coupee

St. HelenaSt. TammanyTangipahoaWashington

West Baton RougeWest Feliciana

AcadiaCalcasieuCameron

IberiaJefferson Davis

LafayetteSt. LandrySt. MartinVermillion

15

*HSSFieldOfficeParishes*

Field Office 4 Field Office 5 Field Office 6

CaldwellEast Carroll

FranklinJacksonLincolnMadison

MorehouseOuachitaRichlandTensasUnion

West Carroll

BienvilleBossierCaddo

ClaiborneDeSoto

Red RiverWebster

AllenAvoyelles

BeauregardCatahoulaConcordiaEvangeline

GrantLaSalle

NatchitochesRapidesSabineVernonWinn

16

*HSSRegulatedPrograms*

Adult Day Health Care Centers

Community Mental Health Centers (CMHCs)

Federally Qualified Health Centers (FQHCs) Medicaid Specialty Units Portable X-Ray

Abortion FacilitiesComprehensive Outpatient

Rehabilitation Facilities (CORFs)

Forensic Supervised Transitional Residential &

Aftercare Facilities

Minimum Data Set (MDS)Resident Assessment

Instrument (RAI)PPS-Excluded Hospital Units

Adult Brain Injury Crisis Receiving Centers (CRCs)

Home & Community Based Service Providers (HCBS)

Non Emergency Medical Transportation (NMET)

Psychiatric Residential Training Facilities (PRTFs)

Adult Day Care Facilities Direct Service Workers (DSWs) Home Health Agencies Nurse Aid Certification &

Training Rural Health Clinics

Adult Residential Care (ARCP)

Elderly or Adult Abuse or Neglect Hospices Nursing Homes Sanction Collection

Ambulatory Surgical Centers (ASCs)

Emergency Medical Transportation (EMT) Hospitals OASIS Therapeutic Group Homes

Behavioral Health Service Providers (BHSPs) Emergency Preparedness Informal Dispute Resolution Organ Procurement

Organizations

Case Management End Stage Dialysis Centers (ESRDs)

Intermediate Care Facility for the Developmental

Disabled (ICF/DDs)Pain Management Clinics

CLIA (Clinical Laboratory Improvements Amendment) Facility Need Review Medicaid Attendant Certified

(MACs)Pediatric Day Health Care

Facilities

17

HealthStandardsSection

RuralHealthClinics

Budget&Workload

June25,2019

JennyHaines,RN,BSN

MedicalCertificationProgramManager

18

Budget&Workload

19

A Real Balancing Act

Budget&Workload

The Federal Budget Call

Letter identifies

the priorities (tiers) of the

State workload.

The federal fiscal year runs from October 1 through

September 30

20

PriorityTiers

uTiersreflectstatutorymandatesandprogramemphasis.

uStatesmustassurethatTiers1and2willbecompletedasapre-requisitetoplanningforsubsequentTiers.

0

10

20

30

40

50

60

70

Tier 1

Tier 2

Tier 3

Tier 4

Workload

Workload

21

TierWorkload

Tier 1Complaint surveys prioritized as potential Immediate Jeopardy complaints.

Full surveys following complaint investigations in which a Condition of Coverage (CoC) was found to be out of compliance.

Tier 2Complaint Surveys prioritized as non-Immediate Jeopardy High complaints.

Recertification Surveys of at least 5% of the non-deemed RHCs.

Relocations of any provider displaced during a public health emergencydeclared by the Governor.

22

TierWorkload

Tier 3Complaint Surveys prioritized as non-Immediate Jeopardy Medium complaints.

Recertification Surveys on RHCs to ensure no more than 7 yearselapses between surveys.

Tier 4Additional Recertification Surveys of non-accredited RHCs to ensure a 6 year average.

Initial Certification Surveys of all RHCs since RHCs have the option to achieve deemed Medicare status through an approved AO.

Relocations of deemed providers.

23

TierWorkload

CMSistargetingnationalannualrecertificationcoverageprioritiesforthenon-LTCprovidersincludingRuralHealthClinics.

24

Accreditation&DeemedStatus

Section1865(a)oftheAct:

AccreditedhospitalsaredeemedtomeetMedicareCoPs

IFtheaccreditingorganization(AO)conductsaDEEMINGsurveyofa

RHCandtheRHCcanprovideacopyofthesurveyreport&approvalletterindicatingthedeemedstatus.

25

DeemedToMeet

AsuccessfulaccreditationsurveymeanstheRHCisdeemedtomeetallConditionsforCoverage.

26

ApprovedAOsforRHCsAmerican Association for

Accreditation of Ambulatory Surgery Facilities (AAAASF)

http://www.aaaasf.org/

The Compliance Team

http://www.thecomplianceteam.org/

5101 Washington St., Suite 2F

P.O. Box 9500Gurnee, IL 600311-888-545-5222

905 Sheble Lane, Suite 102P.O. Box 160

Springhouse, PA 19477Kate Hill: 1-215-654-9110

khill@TheComplianceTeam.org

27

FederallyQualifiedHealthCenters(FQHCs)

CertificationandrecertificationsurveysarenotrequiredforFQHCs.However,CMSinvestigatescomplaintsthatmakecredible

allegationsofsubstantialviolationsofCMSregulatorystandardsforFQHCsasaTier2priority.StateswillusemostofthesamehealthandsafetystandardsastheydoforRHCswheninvestigatingFQHC

complaints.

28

ParticipationinEntirety

uAMedicarehospitalmustparticipateinitsentirety.Selectiveparticipationofcertainbeds,units,campuses,services,etc,isnotpermitted.

uEvenwhereSSApermitscertainexceptions,theexceptionsapplyonlytothosedistinctpartsofaninstitutionwhichmayanddoenterintoaseparateMedicareagreement(i.e.RHCs)

u IfahospitalisgoingtohaveaRHCasanoutpatientdepartmentofthehospital,theRHCmustbecertified.

29

HealthStandardsSection

RuralHealthClinics

Licensing&Certification

June25,2019

JennyHaines,RN,BSN

MedicalCertificationProgramManager

30

LicensingStandards

31

Definitions

Rural Health Clinic (RHC)u-an outpatient primary care clinic

useeking or possessing certification by the Health Care Financing Administration (HCFA)(now CMS) as a rural health clinic,

uwhich provides diagnosis and treatment to the public by a

uqualified mid-level practitioner and a licensed physician

32

*LicensingStandards*

u7501– Definitions&Acronyms

u7503– Licensing

u7505– Denial,Revocation,orNon-Renewal

u7507– Changes/Reporting

u7509– AnnualLicensingRenewal

u7511– Notice&AppealProcess

u7513– ComplaintProcess

u7515– VoluntaryCessationofBusiness

u 7517– PersonnelQualifications/Responsibilities

u7519– Services

u7521– AgencyOperations

u7523– ProceduralStandards

u7525– RecordKeeping

u7529– QualityAssurance

u7531– Patient’sRights&Responsibilities

u7533– AdvisoryCommittee

u7535– PhysicalEnvironment

33

LicensinguAllRuralHealthClinic’s,regardlessoftype,arelicensedasRHCoranoffsite/departmentofthehospital

u LicensemustbedisplayedinanobviousplaceintheRHCatalltimes

u2LicenseTypes:

¡ FullLicense:Insubstantialcompliancewiththerules,standardsandlaw.Theseareissuedfor12months.

¡ ProvisionalLicense:Notinsubstantialcompliancewiththerules,standardsandlaw.Thesecanbeissuedforupto6monthsifthereisnoimmediateandseriousthreattothehealth&safetyofpatients.

34

LicenseuNotassignableortransferable

u Issuedtoaspecificownerandtoaspecificgeographiclocation.

u ImmediatelyvoidedifRuralHealthClinicceasestooperateorifitsownershipchanges.

u Voidedifthehospital(oroff-sitecampus)relocates.

u TheruralhealthclinicmustnotifyHSSatleastfifteendayspriortoanyoperationalchanges.

u RHCmustbeopenandoperationalpriortothelicensingsurvey.

35

3TypesofRuralHealthClinic’s

1. IndependentRHC– licensedandcertifiedasastandalonefacility.

2. Provider–BasedRHC- licensedandcertifiedindependentlybutCCNnumberislinkedtothehospitalCCNnumber(shouldmeettheproviderbasedcriteria).

3. HospitalDepartmentorOffsite- licensedtothehospitalandcertifiedindependentlyasaRHC(shouldmeettheproviderbasedcriteria).

36

Only1License

ARuralHealthCliniccanonlybelicensedasonetype.TheRHCcan’thave2ormorelicenses,i.e.itcan’tbelicensedasafree

standingRHCandaHospitalOutpatientDepartmentsimultaneously.

37

IndependentlyLicensedRHCthatisIndependentlyCertifiedasaRHC

¡Hasitsownindependentlicensewhichisnotlinkedwithanyotherfacilitytype.

¡SubmitsaRuralHealthCliniclicenseapplicationtobecomealicensedRHC(notahospitallicenseapplication)

¡SubmitsaCMS855AtobecomeacertifiedRuralHealthClinicandcheckoffthatitisenrollingasa“RuralHealthClinic”

¡Notassociatedwithahospital.

38

IndependentlyLicensedRHCthatisCertifiedasanIndependentRHCbut

ProviderBasedtoaHospital¡ Hasitsownindependentlicensewhichisnotlinkedwithanyotherfacilitytype.

¡ SubmitsaRuralHealthCliniclicenseapplicationtobecomealicensedRHC(notahospitallicenseapplication)

¡ SubmitsaCMS855AtobecomeacertifiedRuralHealthClinic,checkoffthatitisenrollingasa“RuralHealthClinic”(notahospital),andindicatethatitwillbeproviderbasedtothehospital.

¡ AssociatedwithaHospital

¡ PleasekeepinmindthatthistypemustbeabletodemonstratecompliancewithproviderbasedrequirementsifaskedbyCMS

39

LicensedasanOutpatientDepartmentofaHospital,CertifiedasanIndependentRHCbut

ProviderBasedtoaHospital

¡ Onlyhospitalswithfewerthan50bedscanbeconsideredforthisoption.

¡ ThistypewillhaveaHOSPITALlicensewith“RHC”includedinthelicensenumber. Pleaserememberthatthistypemustdemonstratethatitis100%ownedbythehospitalandcan’toperateseparatelyfromthehospital. Example:Ifthehospitalclosed,theRHCwillautomaticallyclose.

¡ SubmitsaHospitallicenseapplicationtobecomealicensedoffsitecampusoutpatientdepartmentofthehospital(notaRuralHealthCliniclicenseapplication)

¡ SubmitsaCMS855AtobecomeacertifiedRuralHealthClinic,checkoffthatitisenrollingasa“RuralHealthClinic”(notahospital),andindicatethatitwillbeproviderbasedtothehospital. (DoNotsubmitaCMS855Atobecomeapracticelocationofthehospital)

¡ PleasekeepinmindthatthistypemustbeabletodemonstratecompliancewithproviderbasedrequirementsifaskedbyCMS

40

MoreInformationRelativetoHospitalOff-SiteCampusesasitrelatestoRHCs

uAllpremisesonwhichhospitalservices(inpatientand/oroutpatient)areprovidedandthatareNOTadjoinedtothemainhospitalbuildingsorgrounds.

uStatelicensingpurposes=within50milesofthemaincampusandinthestateofLouisiana.

u IfyouparticipateinMedicarethentheoff-sitecampusmustbewithin35milesofthemaincampusandinthestateofLouisiana.

uProvider-baseddesignation=within35milesofthemaincampusandinthestateofLouisiana.

41

Off-siteCampuses

u SubmitaHospitalOff-siteRHCApplicationPacket

u Feeof$300.00peroff-sitecampus

u SubmitCMS855AtoenrollasaRuralHealthClinic(notasapracticelocationofthehospital)

u POPSislinkedtotheFederalAspendatabaseandHealthStandardsisprohibitedfrommakingchangestotheFederalsystemwithouttheCMS855A.

u ContactCMSforprovider-baseddesignation

42

Off-siteCampuses

MUSTS:uMUSTfunctionunderthesameownershipstructureasthemaincampus

uMUSTfunctionunderONEgoverningbodyuMUSTfunctionunderONEmedicalstaffuMUSTfunctionunderONE taxIDnumberuMUSTfunctionunderONEunifiedmedicalrecordsystemuMUSTfunctionunderONEorganization-levelpoliciesuMUSTfunctionunderONEnursingdepartmentuMUSTfunctionunderONEqualityassurance/performanceimprovementdepartment

uMUSTfunctionunderONEinfectioncontroldepartment

43

Off-siteCampuses

MUSTNOTS

uMUSTNOThaveadifferentownershipstructurethanthemaincampus

uMUSTNOThaveaseparatetaxIDnumberfromthemaincampus

uMUSTNOThaveindependentcomplianceatdifferentlocations.Non-complianceatonelocationequalsnon-complianceatalllocations

44

Off-siteCampuses

uProvidersmustprovidenoticetoCMSandtheSAwhenplansaremadetoaddpracticelocations

u Intheabsenceofnotificationofanexpansion,CMShastheauthoritytodenybillsforservicesfurnishedattheexpandedsite.

45

Packets

Licensing Name/Ownership

Location Personnel/Hours

Type

Initial Licensing

Legal Name Change

Relocation Key PersonnelChange

Conversion from Hospital

Offsite to Free Standing

License Renewal

DBA NameChange

Mailing AddressChange

OperationalHours

Change

Conversion from Free

Standing to Hospital Offsite

Closure Ownership StructureChange

Corporate AddressChange

Other

46

InitialLicensing&CertificationPackets

RHCsmustbelicensedinthestateofLouisiana

(eitherindependentlyorasanoutpatientdepartmentofahospital)

47

InitialLicensing&CertificationStep 1. Submit a Complete Licensing & Certification Packet

Licensing Documents For Free Standing RHCs

Licensing Documents for Hospital Offsite RHCs

RHC License Application HSS-HO-55 Offsite Addition and Changes

Payment of $600 HSS-HO-017e Hospital Offsite Campus RHC Addition Supplement

Site Verification Payment of $300

OSFM Plan Review (DH Plan Review) Site Verification

Plan Review Attestation OSFM Plan Review (DH Plan Review)

OSFM Walk Through Inspection Plan Review Attestation

OPH Walk Through Inspection OSFM Walk Through Inspection

Ownership Diagram OPH Walk Through Inspection

EP Attestation Ownership Diagram

EP Attestation

48

InitialLicensing&Certification

Step 1. Submit a Complete Licensing & Certification Packet

Licensing Packets Licensing PaymentsMail to:

Louisiana Department of HealthHealth Standards SectionATTN: RHCP.O. Box 3767Baton Rouge, LA 70821

Mail to:LDH Licensing FeeP.O. Box 62949New Orleans, LA 70162-2949

49

InitialLicensing&CertificationStep 1. Submit a Complete Licensing & Certification Packet

Certification Documents for Free Standing RHCs

Certification Documents forHospital Offsite RHCs

Approved CMS 855A for the Initial Enrollment as a RHC

Approved CMS 855A for the Initial Enrollment as a RHC

CMS 29 CMS 29

CMS 1561A CMS 1561A

OCR Clearance

50

InitialLicensing&CertificationStep 1. Submit a Complete Licensing & Certification Packet

Enrollment

Contact Information for Medicare Administrative Contractors (MAC)

Part A Contractor: Novitas SolutionsJH Provider Enrollment Services,

P.O. Box 3095, Mechanicsburg, PA 17055-1813

http://www.novitas-solutions.com/855-252-8782, Option 4

Tips to Facilitate the Medicare Enrollment ProcessConsider using PECOS (Provider Enrollment Chain & Ownership System)Submit the current version of the CMS 855A http://www.cms.hhs.gov/CMSForms/CMSForms/list.aspSubmit the correct application for your provider typeSubmit a complete applicationRequest & obtain your NPI number before enrolling or making a change in your Medicare enrollment info https://nppes.cms.hhs.gov/Submit the Electronic Funds Transfer Authorization Agreement (CMS-588) with your enrollment (if applicable).Submit all supporting documentationSign & date the application (by the appropriate individuals)Respond to requests for additional information promptly.

Medicare Enrollment Application for Institutional Providers

This is the one for all hospital & Rural Health Clinic actions.

Medicare Enrollment Application for Clinics, Group Practices, and Certain Other Suppliers

Not for certification of hospitals & RHCs. Also, cant use CMS 855I, CMS 855R, CMS 855O & CMS

855S

51

InitialLicensing&CertificationStep 2. License Issued

Free Standing RHCs Hospital Offsite RHCsLicense Issued By Attestation License Issued By Attestation

Expiration Date is the last date of month prior to anniversary month of the following

year.

Expiration Date will be the Expiration Date of the Hospital

On-site Licensing Survey will be Completed Within 6 to 8 months

52

InitialLicensing&Certification3. Certification

Free Standing RHCs Hospital Offsite RHCsMust successfully undergo an Accrediting

Organization (AO) SurveyMust successfully undergo an Accrediting

Organization (AO) Survey

The AO will issue an approval letter to CMS The AO will issue an approval letter to CMS

CMS will forward the AO letter to the HealthStandards

CMS will forward the AO letter to the HealthStandards

Health Standards will update the Federal Database for CMS & forward the Initial

Certification Packet to CMS

Health Standards will update the Federal Database for CMS & forward the Initial

Certification Packet to CMS

CMS will place the packet in line for processing. Once processed CMS will issue a CMS number to the provider using the email

address updated into the system.

CMS will place the packet in line for processing. Once processed CMS will issue a CMS number to the provider using the email

address updated into the system.

53

InitialCertification

uMustbelicensedpriortoundergoinganaccreditingsurvey

uAsuccessful(deeming)surveybyanapprovedAOwillcountasaninitialcertificationsurveyandwillbeyourquickestwaytocertification

uThesearealwaysUNANNOUNCED.

54

ProviderNumber

uCMSwillissuetheCCN(CMScertificationnumber).

u InLouisianathatnumberwillalwaysstartwith“19”

uNPI(NationalProviderIdentifier)numbersaredifferentfromtheCCN.

uAnythingbeingbilledunderanyofthehospital’sNPInumbersmustbelicensedtothehospital.

55

LicenseRenewals

u Mustberenewedannuallyusing:¡ RHCLicenseRenewalPacketifindependentlylicensedasaRHC

¡ HospitalLicenseRenewalPacketiflicensedasanoutpatientdepartmentofahospital

¡ YOUCAN’THAVEBOTHTYPESOFLICENSES

u Renewallettersaresentoutatleast75dayspriortotheexpirationofthelicense.

u Accordingtothelicensingstandardsyoumustreturntherenewalpacketatleast15daysbeforeyourlicenseexpires.

u However,inrealityifyouwaitthatlongtosubmityourpacket,itwillnotmakeittoHealthStandardswithenoughtimetoprocessitbeforeyourlicenseexpires.

56

LicenseRenewals

uThebestrecommendationistosubmititsothatitarrivesatleast30daysbeforeyourlicenseexpires.Ifyoudosubmititatthelastminute,wecan’tguaranteethatitwillberenewedbytheexpirationdate.

uPleasedon’tholdyourlicenserenewalpacketwhileawaitingthefire/healthinspections.IfyourinspectionhasnotbeencompletedbytheOSFM/OPH,pleaseincludeanemailfromtherespectiveofficesconfirmingthatyouareonthescheduleforaninspection.Oncetheinspectionhasbeencompleted,youarerequiredtosubmittheinspectionformtoHealthStandards.

57

LicenseRenewals

uDon’tsubmitchangesonyourLicenseRenewalPacket.Ifyouwanttomakeachange,submittwopackets:onepacketshowingexactlywhatyouarealreadylicensedforandasecondpacketshowingthechange.

uDon’tpayforalicenserenewaltwice.Ifyougetasecondrenewalnotice,checkwithDestinnorTammytoseeiftheyhavethepaymentbeforesendingasecondone.

58

ProviderBased?

u “However,assignmentofthisCCNdoesnotconstituteaCMSdeterminationthatyouhavesatisfiedallapplicablerequirementsforprovider-basedstatusestablishedunder42CFR413.65. YouareundernoobligationtoseekadeterminationfromCMSthatyousatisfyallapplicablerequirementstobeconsideredprovider-based. Youare,however,obligatedtomeettheserequirementsandyoucouldbesubjecttorecoverybyCMSofoverpayments,shouldyoufailtocomplywithanyapplicableprovisionsof42CFR413.65. Youmay,therefore,wishtoconsiderseekingonavoluntarybasisaCMSdeterminationofwhetheryousatisfytheprovider-basedrequirements,inanefforttoreduceyourpotentialexposuretorecoveryofoverpayments. ForquestionsregardingobtainingaCMSprovider-baseddetermination,pleasecontacttheDivisionofFinancialManagementandFeeforServicesOperationsat214-767-6441.”

59

Ownership

60

OwnershipDiagram

uOwnershipDiagramsquicklyshowallindividualsandentitieswithdirectorindirectownershipintheenrolledprovider.

61

ChangesinOwnership

uChangesinownershipstructurecanbeprocessedinoneoftwoways:

¡ ChangeinInformation(CHOI)

¡ ChangeinOwnership(CHOW)

uRegardlessofwhichwayitisprocessedyouwillneedtosubmitachangeofownershipstructurepackettoHealthStandards.

62

ChangesinOwnership

LicensingStandards&Federal42CFR489.18

uAchangeinownership(CHOW)isthesaleortransfer(whetherbypurchase,lease,giftorotherwise)ofaRHCbyaperson/corporationofcontrollinginterestthatresultsin:

¡ achangeofownershiporcontrolof30%orgreaterofeitherthevotingrightsorassetsor

¡ theacquiringperson/corporationholdinga50%orgreaterinterestintheownership.

63

ChangesinOwnership

uExamplesofCHOWS:

¡ Unincorporatedsoleproprietorship:transferoftitleandpropertytoanotherparty

¡ Corporation:Themergeroftheprovidercorporationintoanothercorporation,ortheconsolidationoftwoormorecorporations,resultinginthecreationofanewcorporation.

64

ChangesinOwnership

uExamplesofCHOWS:

¡ Partnership&LLCs:Inthecaseofapartnership,theremoval,additionorsubstitutionofapartner,unlesspartnersexpresslyagreeotherwise,aspermittedbyapplicablestatelaw.

¡ Leasing:TheleaseofallorpartofaproviderfacilityconstitutesaCHOWoftheleasedportion.

65

ChangesinOwnership

NoticetoHSS

u Nolaterthan15daysaftertheeffectivedateoftheCHOW,theprospectiveownershallsubmittothedepartmentacompletedapplicationfortheCHOW.Alicenseisnottransferablefromoneentityorownertoanother.

u PleasenotethatassoonastheCHOWoccurs(effectivedate)thecurrentlicenseisnolongervalid.UponsubmissionofaCHOWpacket15daysfollowingtheCHOW,theRHCmaybegrantedupto90daystoobtaintheCMS855Aonacase-by-casebasis.

u NootherlicensingactionswillbeprocesseduntiltheCHOWiscompletedbecausethelicenseisnolongervalid.

NoticetoCMS

u AproviderwhoiscontemplatingornegotiatingachangeofownershipmustnotifyCMS.

66

ChangesinOwnership

IftheRHCundergoesmultipleCHOWs/CHOIsinashortperiodoftime(evenif1minuteapart),

EACHtransactionmustbeprocessedinitsentiretybeforeanothertransactionwillbe

processed.

67

ChangesinOwnership

ProviderAgreement

uCMSautomaticallyassignstheprovideragreementtothenewowners.

uThenewownersmay formallynotifyCMSthattheyplantoreject“assignment”oftheprovideragreement.

uWhenthenewownerdoesnotacceptassignmentofthepreviousowner’sprovideragreement,theprovideragreementisvoluntarilyterminated.IfthenewownerwishestoparticipateinMedicare/Medicaid,itistreatedasanewapplicant.

68

ChangesinOwnership

EffectsofAccepting AssignmentoftheProviderAgreement

uNewownersretaintheMedicareandMedicaidprovideragreements.

uNewownersareresponsibleforallknownandunknownMedicareandMedicaidliabilitiesofpreviousowners

uNobreakinMedicareorMedicaidpayments

uNosurveyofCoPsrequired.

u Retainsallapplicablepaymentstatuses,includingruraldesignation

69

ChangesinOwnershipEffectsofRejecting AssignmentoftheProviderAgreement

u Arejectionoftheprovideragreementisavoluntaryterminationoftheagreementandmeanstheprovidernolongerexists.

u WhentheMedicareprovideragreementterminatessodoestheMedicaidprovideragreement.

u Ifthenewownerwishestocontinuetoparticipateitmustreapplyasaninitialapplicant(855,OCR,fullsurveyafterthenewownersbeginprovidingservices).

u AninitialcertificationsurveymustbeconductedbytheAccreditingOrganization

u Lossofanyspecialstatuses(i.e.ruraldesignation,provider-basedstatus,etc.)

70

ChangesinOwnership

EffectsofRejecting AssignmentoftheProviderAgreement

u EffectivedateisnotthesameasthedateoftheCHOW.NeweffectivedateisaftertheRHCmeetsallFederalrequirementswhichcanmeananunknownintervaloftimewithnoMedicare/Medicaidpayment.

71

DBANameChangeOnly

Submit

u IndependentRHC:SubmitaRHClicenseapplicationpacketandcorrespondingdocumentsforthechangeintheDBAnameonly.

uHospitalOutpatientDepartment:SubmittheHospitalNameChangePacket

72

EntityNameChange

Submit

u IndependentRHC:SubmittheRHCLicenseApplication&correspondingdocumentswhentheRHCischangingtheentityname.

uHospitalOutpatientDepartment:SubmittheHospitalNameChangePacket

PleasenotethatiftheentitynamechangeisdeterminedtobeaCHOWyouwillneedtosubmitaCHOWdocuments.

73

RHCRelocations

u Sinceeachlicenseisissuedtoaspecificgeographicaddress,anewlicensewillneedtobeissuedifaRHCorhospitaloff-sitecampusrelocates.TheoriginallicensewillneedtobereturnedtoHSS.

u Ifyourelocatethelicenseisnolongervalidmeaningyoudon’thavealicensedRHC.

u Arelocation,inmostcases,willrequireaninspectionbyaHealthStandardssurveyor.

u Submit¡ IndependentRHC:SubmittheRHClicenseapplicationalongwithcorresponding

documentswhentheRHCisrelocating.

¡ HospitalOutpatientDepartment:SubmittheHospitalOffsiteAdditionandChangesPacket

74

Relocations

uContinuationoftheproviderunderthesameprovideragreementispossibleiftheRHCcontinuesservingthesamecommunity.ThisisdecidedbyCMS.

uVoluntaryterminationunder489.52occursiftherelocationis“sofar”fromtheoriginallocationastoresultinacessationofbusinesstotheoriginalcommunity.

uThespecificcircumstancesofthecommunityservedwillimpactthedeterminationofwhethertheRHCisservingthesamecommunity.

75

ServiceAction

IftheRHCisadding/deleting aservice(i.e.outpatientradiology,lab,primarycareservice,etc.)orchanginganythingaboutthewayaserviceisbeingprovided orwheretheserviceisbeingprovidedorthesizeofthespacewheretheserviceisbeingprovided,theRHCwillneedtosubmit:

¡ IndependentRHC:SubmittheRHClicenseapplicationalongwithcorrespondingdocuments

¡ HospitalOutpatientDepartment:SubmittheHospitalServiceActionPacket

76

RHCClosureClosure

u IndependentRHC:SubmitaRHClicenseapplicationandcorrespondingdocumentsfortheclosure.

u HospitalOutpatientDepartment:SubmittheHospitalVoluntaryClosure(MainorOffsiteCampus)Packet.

ThehospitalistonotifyHSSinwritingwithin14daysoftheclosureofanoff-sitecampuswiththeeffectivedateofclosure.Theoriginallicenseoftheoff-sitecampusistobereturnedtoHSS.

Cessationofbusiness:

¡ deemedtobeeffectivewiththedateonwhichtheRHCstoppedprovidingservicestothecommunity.

u EntireHospitalclosure:

¡ ThehospitalmustnotifyHSSinwriting30dayspriortotheeffectivedateofclosure,mustsubmitawrittenplanforthedispositionofthemedicalrecords,publishnoticeinthenewspaperandreturntheoriginallicensetoHSS.

¡ PleasekeepinmindthatshouldthehospitalclosethenallassociatedRHCswillnolongerbelicensedorcertified.

¡ ShouldthehospitalloseitsprovidernumberthenanyassociatedRHCswillbeimpactedbecausetherewillbenocertifiedhospitaltobeproviderbasedto.

77

PlanReviews

u DeletionoftheDivisionofEngineeringandArchitecturalServices

u Effective July2011the Departmentof PublicSafety (DPS),OfficeoftheStateFireMarshal conductsplanreviewsofcertainhealthcarefacilitieslicensedbytheLouisianaDepartmentofHealth(LDH).

u PleasekeepinmindthattheOfficeofStateFireperformstwotypesofplanreviews:

¡ 1)TheLDHPlanReviewreferredtoasthe“DHReview”(theOfficeofStateFireMarshalcanNOTexemptyoufromthisreview)

¡ 2)TheLifeSafety/OccupancyPlanReviewreferredtoasthe“ARReview”(theOfficeofStateFireMarshalmayexemptyoufromthisreview)

u IfthehealthcareentityisnotlicensedbyLDH- HealthStandardsSection(HSS)thennoHealthStandardsplanreviewisrequiredbyDPS.

78

*PlanReview*

uNewbuildingstobeusedasaRHC

uAdditionstoexistingbuildingstobeusedasaRHC

uConversionsofexistingbuildingsorportionsthereofforuseasaRHC

uPleasekeepinmindthatCMSstatesthatonlyonebuildingcanbecertifiedastheRHC.TheRHCCAN’Thavemultiplebuildings.

79

ApprovalofPlans

uNoticeofsatisfactoryreviewfromtheOfficeofStateFireMarshalconstitutescompliancewiththisrequirementifconstructionbeginswithin180daysofthedateofsuchnotice.

uThisapprovalshallinnowaypermit,and/orauthorizeanyomissionordeviationfromtherequirementsofanyrestrictions,laws,ordinances,codesorrulesofanyresponsibleagency.

80

NewRHCLicenseApplication

81

*Packets–WhatHappensToMyPacket

u PostOfficeBox3767,BatonRouge,LA70801u SomeonefromLDHretrievesthemailattheUSPSuMailgoestotheMailRoomatBienvilleBuildingwhereitissorted.u DeliveredtoHealthStandardsreceptionistintheBienvilleBuildinganddated

u Placedintheappropriateprogramdeskmailboxu Pickedupbytheadministrativeassistant,loggedintothedatasystemandplacedinthequeueforprocessing.

u AtanyonetimethereareMANYpacketsinlineforprocessingsosubmitEARLYinyourplanningprocess.

u IfyouemailthepacketitwillbeplacedinthequeuebyTammyWalton

82

Packets–WhatHappensToMyPacket

u LicenseRenewalPackets arehandledbytheAdministrativeAssistant.¡ PleasecontactDestinn.OBear@la.gov foranyquestionsregardingyourlicenserenewalofRHCsthatareoutpatientdepartmentsofhospitals.

¡ PleasecontactTammy.Walton@la.gov foranyquestionsregardingyourlicenserenewalofindependentlylicensedRHCs

uAllSurveys,PlansofCorrection,RegulatoryQuestions&WaiversforRHCsarehandledbytheProgramManagerforSurveys.PleasecontactJennifer.Haines@la.gov orDebby.Franklin@la.gov foranyquestionsregardingyoursurvey,planofcorrection,regulatoryquestionsorwaivers.

83

Packets–WhatHappensToMyPacket

uAllComplaints,SelfReportsandKeyPersonnelChangesareplacedinthelinefortheComplaintManager.PleasecontactJanice.Louis@la.gov forquestionsregardingcomplaints,self-reportsandkeypersonnelchanges.

uAllotherpacketsareplacedinthelineforprocessingbytheRHCprogrammanager.

84

Packets–WhatHappensToMyPacket

uOncethepacketmakesittotheProgramManager’sdesk,itisreviewedforaccuracyandcompleteness.

u Ifcompleteitisprocessed.

u Ifincompleteaninstructionalletterwillbesenttotheprovider.

uUnfortunatelygreaterthan70%ofpacketsareincomplete.

85

Whatyoucandotoassisttheprocess

uSubmitonlycompletedpackets

uPlacethechecklistonthefrontofthepackets

uSubmityourpacketveryearlyinyourplanningprocesses.

uRemembertosubmityourplanreviewsearlyintheprocess

uRemembertosubmityour855Asearlyintheprocesssincethestatesystemisnowlinkedtothefederalsystem.

uWhencallingtocheckthestatusofyourpacket,pleaseexplaintoDestinnorTammywhatyouarecallingforandshewillcheckthestatusofyourpacket.

86

TeamWork

87

HealthStandardsSection

RHCSurveys

June25,2019

JennyHaines,RN,BSN

MedicalCertificationProgramManager

88

RHCSurveys/RegulationsType of Survey Licensing Regulations Federal Regulations

Initial Licensing Survey RHC Licensing Standards

Relicensing Survey RHC Licensing Standards

Initial Certification Survey

RHC Conditions for Coverage & AO Standards

Recertification Survey RHC Conditions for Coverage & AO Standards (if accredited)

Complaint Survey RHC Licensing Standards RHC Conditions for Coverage

89

InitialLicensingSurvey

InitialLicensingSurvey

uThisisanannouncedsurveycoordinatedbetweentheprovider&FieldOffice

uRHCsmustbeoperationalandhaveseenatleast5patientspriortothesurvey

uAllStateLicensingStandardsmustbemet

ResultsofInitialLicensingSurvey

No Deficiencies

Survey Aborted

Plan of Correction Requested

License Denied

Initial Survey

90

AnnualLicensingSurvey

AnnualLicensingSurvey

Althoughre-licensingsurveysshouldbeperformedannually,thefrequencyofre-licensingsurveysaredeterminedby

theannualbudget.

ResultsofAnnualLicensingSurvey

No Deficiencies Plan of Correction Requested

Follow Up Survey Action Taken on License

Annual Licensing Survey

91

Conditions forCoverage

Conditions for

Coverage

To qualify for Medicare

certification, providers must

comply with minimum health & safety

standards

These standards are termed “Conditions for Coverage” (CfCs) as it relates to Rural

Health Clinics

They are embodied in Title XVIII of the

Social Security Act.

92

ConditionsofCoverage

Conditions for

Coverage

491.4Compliance with Federal, State &

Local Laws

491.5Location of

Clinic

491.6Physical Plant &

Environment

491.7Organizational

Structure

491.8Staffing & Staff Responsibilities

491.9Provision of

Services

491.10Patient Health

Records

491.11Program

Evaluation

93

InitialCertificationSurvey

InitialCertificationSurvey

u ResourcesforInitialCertificationSurveysarehighlyconstrainedduetothecurrentbudgetforSurvey&Certification.

u CMSlongstandingpolicymakescomplaintinvestigations,re-certifications,andothercoreworkforexisting Medicareprovidersahigherprioritycomparedwithcertificationofnew Medicareproviders.

u ProvidershavetheoptionofattainingaccreditationthatconveysdeemedMedicarestatusconductedbyaCMS-approvedaccreditationorganization(inlieuofMedicaresurveysbyCMSorStates).Providersareadvisedthatsuchdeemedaccreditationislikelytobethefastest routetocertification.

u ThisCertificationprocesscanonlytakeplaceaftertheproviderhasbeenissuedalicensebytheState.

ResultsofInitialCertificationSurvey

No Deficiencies

Deficiencies Cited & Plan of Correction Requested for:

Standard LevelCondition Level

Immediate Jeopardy

Follow Up Survey

Certification Approved or Denied

CMS has ultimate authority for certification approval

Initial Certification

Survey

94

Re-CertificationSurvey

AccreditedRHCs

uAccreditationisgrantedfor3years

uTheAccreditingOrganizationwillconductanunannouncedreaccreditationsurveypriortotheexpirationofthecurrentaccreditationsurvey.

uAllAOstandardsarereviewed.

Non-AccreditedRHCs

uOnceayearCMSissuesapriorityscheduletoHealthStandardsoutliningthetypesoffederalsurveystobeconducted.

u RHCareselectedforunannouncedrecertificationsurveysbasedontheprioritydocument

u AllConditionsforCoverage&LifeSafetyCodesarereviewed

u Re-licensing&recertificationsurveysareusuallyconductedconcurrentlyexceptforHospitalOffsiteRHCswhichmaybeonadifferentschedule.

95

Re-CertificationSurveyNo

Deficiencies

Certification Continued

Standard Level Deficiencies

Plan of Correction (PoC) Requested

Certification Continued unless failure to submit

PoC

Condition Level Deficiencies

Plan of Correction Requested

90 Day Termination Track

Follow Up Survey

Deficiencies Cleared, 90 Day Ends & Certification

Continues

Deficiencies Cited, 90 Day Continues

Follow Up, Deficiencies Cleared, 90 Day Ends, Certification Continues

Follow Up, Deficiencies Cited, Certification Ends

Immediate Jeopardy

Plan of Correction Requested

23 Day Termination Track

Follow Up Survey

IJ removed & Deficiencies Cleared, 23 Day Ends, Certification Continues

IJ Removed, Conditions remain, 90 Day Termination

from date of survey

Follow up, Deficiencies Cleared, 90 Day Ends, Certification

Continues

Follow Up, Deficiencies Cited, Certification Ends

96

ConditionsofCoverage

Please note that if a deemed RHC is found to be not in compliance with one or more CfCs:• CMS removes the “deemed

status’ and the RHC is notified by letter.

97

Timeline

Day 15

• State Agency sends the SoD & letter to provider indicating there is a determination of non-compliance & placing the facility on a 90 day termination track. Provider has 10 calendar days to complete plan of correction & return it to the State Agency.

Day 25•Provider must have an acceptable Plan of Correction back to the State Agency

Day 35

•Provider MUST be ready for a the first follow up revisit by this date•Only 2 revisits are permitted

Day 55• If provider is not in compliance, the State Agency certifies non-compliance and

sends the information to CMS

Day 65•CMS determines whether survey findings continue to support a determination of

non-compliance

Day 70•CMS sends an official termination notice to the provider

Day 90•Termination takes effect if compliance is not achieved.

98

April 3, 2014

Administrator ABC Hospital 123 Dark Street Happy Town, LA XXXXX

Medicare Provider # XXXXX

E-MAIL – READ RECEIPT REQUESTED

Dear Administrator:

On the basis of the deficiencies found to exist in your facility on 01/15/2014, it no longer appears that ABC Hospital qualifies as a provider of services in the Medicare program. To participate in Medicare, a provider must meet the statutory requirements established under Title XVIII of the Social Security Act and must also meet health and safety requirements prescribed by the Secretary of the U. S. Department of Health and Human Services. The results of the 01/15/2014 survey confirmed that ABC Hospital is out of compliance with the following Medicare Conditions of Participation:

42 CFR 482.13 Patient Rights

The CMS form 2567 Statement of Deficiencies is enclosed for your response and is to be returned to this office signed and dated by the administrator or other authorized official as indicated. The plan of correction must be entered on the original statement of deficiency report and must be specific, realistic and state how the deficient practice will be prevented from recurring. Refer to the enclosed “Required Components for a Plan of Correction” for guidance in developing your Plan of Correction. The Plan of Correction must be completed and returned to this agency within 10 days after receipt of this letter or action to terminate your agreement will proceed as scheduled. Proposed Plan of Correction completion dates for the Conditions of Participation and related deficiencies cannot exceed April 19, 2014 (35th day). Compliance with all Conditions of Participation must be achieved at the time of this revisit if further action is to be avoided.

If the deficiencies have not been satisfactorily corrected at the time of this revisit, a certification of non-compliance will be forwarded to the Centers for Medicare and Medicaid Services (CMS) with the recommendation that your Medicare provider agreement be terminated effective April 15, 2014. In that event, you can expect to receive a letter from CMS advising you of the exact date of termination and your appeal rights. During that period, CMS will give public notice of the date of termination and the reasons for termination. Once terminated, you can anticipate being out of the Medicare program for at least 60 days.

90 day termination letter

99

Whattodonow?

uFirst-Getstartedfixingtheproblemassoonasthebroughttoyourattention.DONOTWAITtoreceivethestatementofdeficiencies.

uReachoutforhelp-especiallyifyouhaveconditionleveldeficiencies.

¡ StateOfficeisnotallowedtoconsult….butthatdoesnotapplytoallagencies

� TraciIngram’sgroupcanbeaveryvaluableresource

100

ComplaintSurvey

u JaniceLouis,RNhandlescomplaintintakes

Stateand/orFederalRegulations

uSurveyorswillreviewthecorrespondinglicensingregulationsandfederalConditionsofParticipation/Coveragerelativetothecomplaint.

101

StandardDeficienciesOnly

uStatementofdeficienciessenttotheprovider.

uProviderhas:

¡ 10businessdaysfromthedateofreceipttocompleteplanofcorrectionandsendtoRHCC&Sdesk.

¡ Mustsendalldocumentationcreatedorchangedtoaddresstheciteddeficiencies.(i.e.,updatedorchangedpoliciesandprocedures,auditsheetscreated,staffin-servicesigninsheets).

¡ PlanneedstobesigneddatedandtitledbyCEOorauthorizedsignature.

102

PlansofCorrection

Corrective Action Date

How were corrective Actions accomplished for those patients affected

by the deficient practice.

Describe how others that have the potential to be affected by the deficient practice will be identified, and what will

be done for them.

Document measures put into place to ensure the deficient practice will not

recur

How will the facility monitor its performance to make sure solutions are

sustained (Who, How, How Often)

Include the date the corrective action will be completed. Please keep in mind that immediate interventions should be

started…don’t wait until the last possible date to make corrections.103

PlansofCorrection

Tips

If you indicate that polices were changed, please include a copy of the

policy

If you indicate that staff were trained, please include a copy of the training

provided & the sign in sheet demonstrating staff were trained

If an advisory meeting did not occur, please schedule the advisory meeting prior to the corrective action date,

include the agenda for the meeting, and the sign in sheet.

If there were deficiencies regarding the environment, please send photos

demonstrating how the environmental issues were corrected.

Please ensure that you sign and date the first page of the federal SoD and State

SoD (if a concurrent licensing survey was conducted)

104

Mostfrequentlycitedtags

Most Frequent

23 & 24Maintenance

72Protection of Records

320Physical

Environment

77Annual Total

Program Evaluation

57Patient Care

Policies

58Patient Care

Policies

175Procedural Standards-Infection Control

255Quality

Assurance

290Advisory

Committee

105

Pleaseremember:

KeepCEO/AdministratorinformationwithusCURRENT–ThisdatabaseisalsousedbyCMS

PoC’s aresentviae-mailtoHSSNLTCSurveyPackets@la.gov

or

MailedtoHealthStandardsSection,P.O.Box3767,BatonRouge,LA70821

Bothahardcopyande-mailarenotneeded!

106

HealthStandardsSection

TheSurveyProcess

June25,2019

JennyHaines,RN,BSN

MedicalCertificationProgramManager

107

SIXSURVEYTASKS

Survey

Offsite Preparation

Entrance Conference

Information Gathering

Decision Making/Analysis

of Findings

Exit Conference

Post Survey Activities

108

Task1:Off- SitePreparation

Determine the Team Composition

Team Building Survey Direction

Size of the Facility Assign Team Leader Identify concerns to be investigated

Complexity of Services Coordinate time/place for team to meet

Identify persons to be interviewed

Type of Survey Team Assignments Gather form needed for the type of survey

Historical Pattern of Deficiencies

Facilitate TimeManagement

Media Sources Encourage on-going communication

Complaints Set projected exit date/time

109

Task2:EntranceConference

Upon Arrival Conference Process Examples of Information that may be requested

Ask to speak to the Administrator or to whomever is in charge at the moment the team enters if the Administrator is not available.

Explain purpose & scope of survey & set a projected exit date/time

Secure a private area for surveyors to work and discuss survey findings

List• Current list of patients

with name, diagnosis, admission date, age, attending MD & significant data

• Staff members• Employees• MDs/allied health workers• Contracted services

The survey will not be delayed because the Administrator or other staff are not on site or available.

Briefly explain the survey process

Ensure that surveyors are able to obtain photocopies of materials, records, and other info needed

Governing Body BylawsGoverning Body RulesMedical Staff BylawsMedical Staff Rules Meeting MinutesAdvisory Minutes

Introduce self, team, and state purpose of the visit.

Clarify that all areas under the license/provider number may be surveyed, including any contracted patient care activities.

Explain that all interviews will conducted privately with patients, staff and visitors, unless requested otherwise by the interviewee.

Policies & ProceduresInfection Control PlanQuality Assurance PlanEmergency Plan & Drills

110

Task3:InformationGatheringThe objective is to determine compliance with Medicare Conditions for Coverage and/or the licensing standards through observations, interviews, and

document review

Observations Interviews Examples of Record/DocumentReview (But not limited to)

Policies & ProceduresQAPI

• Provision of patient care• Interactions between staff &

patients• Medication storage/handling• Medical Record storage/handling• Environment

(safe/clean/uncluttered)• Biohazardous materials• Pest Control• Equipment use/inspections• Integration of all services to

ensure facility is functioning as one integrated whole

• Cleaning solutions (labeled & used appropriately)

• Universal precautions• Hand Washing• Handling/processing linen• Handling/processing instruments• Facility Wide Quality Assurance • Facility Wide Infection Control

• The State Agency and surveyors have discretion in allowing facility personnel to accompany the surveyors during the survey/interviews based on the circumstances at the time of the survey.

• Interview with patients & families about their care & knowledge of their illness.

• Interviews with staff regarding knowledge of patients & care needs

• Interviews with staff regarding policies & procedures, and areas of concern found during the survey

• Interviews with physicians/mid level practitioners regarding patient care services

• Interview with key personnel regarding their knowledge of policies & procedures

• If key personnel are unavailable who is the person designated to act in that person’s absence.

• Patient Medical Records (open & closed)

• Actual & Potential Patient Outcomes

• Consent Forms (dated, signed)• Assessments completed• Plans of Care initiated &

updated• MD orders followed &

documented appropriately• Progress notes to include care

plan problems addressed with documentation of treatments provided.

• Comprehensive discharge planning

• Employee Files• Medical/Nursing Staff Files• Governing Body Bylaws, Meeting

Minutes• Medical Staff Bylaws, Meeting

Minutes• Quality Plans & Data• Infection Control & Data• Advisory Meeting Minutes• Sign in Sheets• Maintenance records• Equipment Inventory• Emergency Drills• Fire/Health inspections• Contracts• Grievances

• Reviewed annually & updated • Reflect the intent of State &

Federal regulations• Reflect the facility practice• Address all areas of practice

provided by the provider• Does QAPI show evidence there

are measurable improvements in indicators for which health outcomes will be improved.

• Does the plan include a system to measure, analyze, and monitor the effectiveness, safety of services, quality of care and track performance?

• Are preventative actions put in place & improvements sustained?

• Is there documentation of QAPI projects conducted annually, reason for choosing the projects, and the measurable progress achieved on the projects.

• Is there evidence all services/areas & contracted services are involved in QAPI

• Does the Governing Body have oversight & specify in writing the frequency & detail of data collection.

111

Task4:AnalysisofFindings&DecisionMakingThe objective is to review & analyze findings and determine whether or not

the RHC meets the regulatory requirements.

Observations

• The team meets in private to discuss all areas of concern to determine whether the facility has met the regulatory requirements.

• Surveyors will review his/her notes and share findings with the team.

• Decisions about deficiencies are to be team decisions, with each member having input.

• If deficiencies are identified the team will determine the severity of the deficiency.

• A team consensus, with consultation with State Office, will determine whether a Condition for Coverage will be considered met or not met.

112

Task5:ExitConferenceThis is a courtesy meeting to provide preliminary

findings.Purpose Composition Forms Plans of Correction

• The exit conference is a courtesy meeting that can be ended at any time should the exit conference become adversarial.

• The exit conference is to inform the facility staff of the team’s preliminary findings. These could change after State Agency &/or CMS review

• Tag numbers will not be referenced in the exit conference as these numbers could change.

• The official results are when the RHC receives

• The RHC can decide who will attend the exit conference.

• Because of the ongoing dialogue between surveyors and facility staff during the survey, there should be few instances in which the facility is unaware of surveyor concerns or has not had an opportunity to present additional information prior to the exit conference

• The exit conference form will be provided to the Administrator to sign, date and return to the Team Leader. A copy will be left with the Administrator.

• Please ensure that the administrator provides a current and accurate email address as this will be the address used by the State Agency and CMS in future communications.

• It is also a good idea to give at least one other RHC staff person’s name and email as a contact.

• You will be informed of the process for submitting a Plan of Correction

• POC is to be submitted to

Jennifer.Haines@la.govand

Debby.Franklin@la.goveither by email or mail

to Health Standards Section, P.O. Box

3767, Baton Rouge, LA 70821 within 10

calendar days if the CfC is out or 10

working days is no CfC is out.

113

Task6:PostSurveyActivitiesCompletion of the Survey

Purpose Results

• The survey team will complete the required paperwork and update information in the state & federaldatabase.

• In conjunction with the State Agency & at times with CMS, the survey team will finalize the survey findings.

• If standard level deficiencies are cited with no Conditions for Coverage out of compliance, the survey team will email the CMS 2567/state form (statement of deficiencies) to the provider along with instructions for submitting the Plan of Correction.

• If a Condition for Coverage was found to be out of compliance, the CMS 2567/State Form will be emailed from the State Agency along with the termination notice, IDR/POC instructions.

114

PrimaryReasons

Complaints

Feels that Facility Does

Not Care

Dissatisfaction with Grievance

Process

Valid, unresolved

concerns that arise during treatment

Sense of Powerlessness

Displaced anger related to poor

outcome

Misconceptions about patient’s

condition

Misconceptions about goals of

care

115

Offsitesu Licensing“nontraditional”offsites(e.g.physicians’offices,RHCs,clinics,etc.):

¡ Allrelevanthospitalregulationsnowapply(State&Federal)

¡ ComplaintswillbeprocessedbyLDH

¡ Opentoonsitesurveys(i.e.complaintinvestigations)

¡ Subjecttohospitalpoliciesandprocedures

¡ Hospitaladministrationanddesigneesresponsibleforprocessinggrievances

¡ Clinic/officestaffmembersmustbeeducatedonallrelevantstandards

116

HealthStandardsSection

EmergencyPreparedness

June25,2019

JennyHaines,RN,BSN

MedicalCertificationProgramManager

117

EmergencyPreparednessuNewFederalRegulationspublishedinNovember2016withaNovember2017effectivedate.

118

EmergencyPreparednessu Louisianaknowsaboutemergencies……wemustbepreparedforalltypesofemergencies

119

CMSrule-emergencypreparednessforMedicareandMedicaidproviders

u BecameeffectiveNovember16,2017.

u CanbeaccessedviaeCFR athttps://www.ecfr.gov/cgi-bin/text-idx?SID=6762e9979ce577516fec35efa0cf02eb&mc=true&tpl=/ecfrbrowse/Title42/42tab_02.tpl

u Effects17providertypes.

u IsaConditionofParticipation

u Requiresproviders

Ø toperforman“allhazards”riskassessment

Ø TesttheiremergencyplansbyparticipatingInafullscaleoperationsbasedcommunitywidedrillifavailable,facilitywidedrill,ortabletopexercisesatleasttwiceperyear.Classroomtrainingforstaffdoesnotmeetthetestingrequirement.

Ø Analyzefacilityperformanceduringthedrill,updatetheemergencyplanbasedontheanalysis,andtodocumentchangestotheplan

Ø Haveacommunicationplanthatincludesthefacility’slocalemergencyoperationscenter(EOC)

Ø Trainemployeesuponhireandannuallythereafter120

MonitoringforProviderCompliance

uHealthstandardsAsthemonitoringentityforCMShasadoptedanattestationprocessprovidersarerequiredtocompleteannually

uTheattestationprocesshasbeenincorporatedintotheannuallicenserenewalprocessforallaffectedlicensedproviders

uAttestationisalsorequiredaspartofotherprocessessuchaschangesinownershipandchangesofaddress.

uLicenserenewalswillnotbeprocessedwithoutacompletedapprovedlicenseapplicationaddendumformforthefacility

121

Helpfulinformationforcompletingtheattestationform:

uTheformiselectronicandshouldbefilledoutelectronically.

uThefacilitynamemustmatchwhatisonfilewithstateoffice

uMedicare#fieldreferstothefacilityfederalcertification#-thisnumberbeginswith“19”

uRiskAssessmentandEmergencyPlanning:Reviewofthefacilityemergencyplanisanannualrequirement– n/aisnotanacceptableanswerhere

uTrainingandTesting:Providersmustsubmit2testdatesor1testdatealongwithadatethefacilityemergencyplanwasactivated.Testdatessubmittedmustbewithinthelastcalendaryear

uActivationofthefacilityplan,ifapplicable– Referstoadatethefacilityplanwasactivatedinarealemergency,notwhenaplanorpolicywasupdatedorputinplace.

122

QuestionsaboutAttestationProcess

uContacts

¡ LibbyGonzales:Libby.Gonzales@la.gov

¡Oklynn Broussard:Oklynn.Broussard@la.gov

123

Tabletopdrills

uLDHBureauofPrimaryCareishostingQuarterlyVirtualtabletopdrillsforproviders.

uThenextscheduledvirtualtabletopdrillinthequarterlyseriesisJuly2,2018.

uForregistrationinformation,PleasecontactNicoleCoarsey,Louisianadepartmentofhealth,LouisianaBureauofPrimaryCare@225-342-4415orNicole.coursey@la.gov.

124

NewExpeditedLicensingProcessuMemodatedDecember20,2018

uFinalrulepublishedintheLouisianaRegisterDecember20,2018.

uFeeforRHCexpeditedsurveyis$6000+licensingfee

uExpeditedsurveyshallbeconductedwithin10workingdays

¡ Thelicensingpacketmustbecompletetostartthe10workingdaystimeline.

¡ TheexpeditedfeeandlicensingfeemustbereceivedbyStateOfficeandclearwiththebank.

u Isthisrightforyou?

125

MobileUnits

uCurrently,wedonotlicensethese.WelicensetheRHCtoonegeographicaladdress,anddonotcurrentlyhavethelicensingcapabilityformobileunits.

126

CHOWsandCHOIs

uHealthStandardshaschangedthewaywehandlethese

u TheRHCprogramdesknolongerhandlestheinitialportionofCHOWsandCHOIs.

u Thoseapplicationsshouldbesentto:HSSOwnerships@la.gov.

uCheckourwebsiteunder“ChangeofOwnershipInformation”

¡ Thereisanewformonthewebsite-nolongerusingtheRH-01forthisaction.

uOncealldocuments(includingthe855A)arereceivedandreviewedbytheCHOW/CHOIprogrammanager,theywillforwardthepaperworktotheRHCprogramdesk.

uAtthispoint,thelicensewillbeissuedandanyotheractionsthatoccurredaspartoftheCHOW/CHOIwillbeprocessed(DBAnamechanges,etc.).

127

128

uBigChanges!!!!!uLicenseRenewalswillallbedoneviaemailnow¡Willbesenttoadministrator’semail¡Imperativethattheadministrator’semailisuptodate

uCanbereturnedtothesameemailaddresstherenewalcamefrom

uLicenserenewalswillcomefrom:HSS-RHC-Licensing@la.gov

129

LicenseRenewals

HealthStandardsSectionLicensing&Certification

Processes

130

131