Health Standards Section Rural Health Clinics Role .

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Health Standards SectionRural Health ClinicsRole & Structure of Health Standards SectionJune 6, 2018Jenny Haines & Debby FranklinMedical Certification Program Managers1

Cell Phones2

Index Cards Lotsof information to cover Useindex cards for questions Printan email address on the back Anyquestions that we don’t know theanswer to we will research and emaila response back to you.3

Beginner to Expert Thispresentation is set up to addressitems that range form beginners toexperts in navigating the licensing &certification process.4 Ifyou are one of the experts, pleasebe patient as we address some of thebeginning processes.

Objectives Definethe role & structure of Health Standards Explainthe workload as it relates to RHCs Explainthe licensing & certification processes for RHCs. Providean overview of the types of surveys and survey process.5

The Secretary of the Department of Health andHuman Services (DHHS) has designated CMS toadminister the Medicare and Medicaid programs.CMS6

CMS Central OfficeCMS’ Health Standards & Quality Bureau is responsible for: survey and certification policies & procedures monitoring adherence to program requirements responding to questions working with states to provide joint oversight of the Medicaid program7

CMS Regional Office Determineseligibility for participation in Medicare Works withstate agencies to evaluate performance Providestechnical assistance Allocatesfunds to state agencies for certification activities Preparesand analyzes CMS data ConductsFederal surveys8

CMS RegionsRegion 1BostonRegion 10SeattleRegion 2New YorkRegion 9 SanFranciscoRegion 3WashingtonCMSCentralOffice inBaltimoreRegion 8DenverRegion 4AtlantaRegion 7Kansas CityRegion 5ChicagoRegion 6Dallas (LA,TX, NM, AR,OK)9

Federal & State RelationshipSection 1864 of the Social Security Act (the Act) establishes theframework within which State Agencies (SAs), under agreementsbetween the State and the Secretary, carry out the Medicarecertification process.10

Federal & State RelationshipState Agency DHH Designated bythe Governor as responsible for performing thefunctions created by Section 1864 of the Social Security Act. Responsibilities include: certification/recertification functions records maintenance identifying potential participants in Medicare/Medicaid complaint investigations validation surveys CLIA activities licensing activities.11

Health Standards Section (HSS) Agencywithin the Department of Health & Hospitals Contracted byCMS to perform the survey &certification functions in the state of Louisiana Enforcesregulatory compliance for health carefacilities Referredto as the “State Agency” (SA)12

HSS Mission/VisionMissionVisionTo enforce regulatory compliance for healthcare facilities in the State of LouisianaThe section will be recognized as a unit ofdedicated health professionals who arefocused on assuring all Louisiana citizensreceive good health services thatencourage better health and promotequality of life.13

DHH & HSSOffice of The SecretarySecretary Dr. Rebekah GeeOffice of Management & FinanceUndersecretary Jeff ReynoldsOffice of Management & FinanceDeputy Director Michelle AlettoHealth StandardsDirector Cecile Castello14

HSS Hospital ProgramDirector Cecile CastelloProgram Manager 2 NLTC Dora KaneLicensing for HospitalRHCsJennifer Haines(Hospital Program Manager) Short Term Acute CareHospitalsCritical Access HospitalsLong Term Care HospitalsRehabilitation HospitalsPsychiatric HospitalsChildren’s HospitalsMedicaid Specialty UnitsRHC off-site CampusesTrauma CentersLicensing for FreeStanding RHCsNew Program Manager(Hospital Program Manager) Short Term Acute CareHospitals Critical Access Hospitals Long Term CareHospitals Rehabilitation Hospitals Psychiatric Hospitals Children’s Hospitals Medicaid Specialty Units RHC off-site Campuses Trauma CentersCertification for RHCsRHC Program Manager Licensing of allindependent freestanding RHCsAdministrative Supervisor Carla Jerome, Katri MartinAdministrative Assistant Destinn O’Bear, Shelly Tyree, Tammy Walton15Program ManagerRHCs & FQHCAll certification action forRHCs

Hospital Program ManagersIf the RHC is an outpatient department of a hospitalLori GuilloryJennifer HainesAllenJacksonSt. HelenaAcadiaJefferson DavisSt. MartinAvoyellesLaSalleSt. nCaddoRed RiverEast Baton RougeNatchitochesWashingtonCalcasieuSabineEast CarrollOuachitaWest BatonRougeClaiborneSt. BernardEast FelicianaPointe CoupeeWest CarrollDeSotoSt. CharlesEvangelineRapidesWest FelicianaIberiaSt. JamesFranklinRichlandWinnIbervilleSt. JohnGrantSabineJeffersonSt. LandrySt. Mary16

HSS Field OfficesAs they relate to hospitalsField Office 1New Orleans& ThibodeauxCherylannWesterfieldFOMField Office 6AlexandriaJackie GreenFOMField Office 2Mandeville &Baton RougeBecky KnightFOMHSS StateAgency FieldManagerDarrenGuilloryField Office4/5 Monroe &ShreveportClarice SteeleFOMTitle 18SupervisorBill WhatleyField Office 3LafayetteRita SimonFOM17

*HSS Field Office Parishes*Field Office 1Field Office 2Field Office eansPlaqueminesSt. BernardSt. CharlesSt. JamesSt. JohnSt. MaryTerrebonneEast Baton RougeEast FelicianaLivingstonPointe CoupeeSt. HelenaSt. TammanyTangipahoaWashingtonWest Baton RougeWest FelicianaAcadiaCalcasieuCameronIberiaJefferson DavisLafayetteSt. LandrySt. MartinVermillion18

*HSS Field Office Parishes*Field Office 4Field Office 5Field Office 6CaldwellEast itaRichlandTensasUnionWest CarrollBienvilleBossierCaddoClaiborneDeSotoRed eVernonWinn19

*HSS Regulated Programs*Adult Day Health CareCentersCommunity Mental HealthCenters (CMHCs)Federally Qualified HealthCenters (FQHCs)Medicaid Specialty UnitsPortable X-RayAbortion FacilitiesComprehensive OutpatientRehabilitation Facilities(CORFs)Forensic SupervisedTransitional Residential &Aftercare FacilitiesMinimum Data Set (MDS)Resident AssessmentInstrument (RAI)PPS-Excluded Hospital UnitsAdult Brain InjuryCrisis Receiving Centers(CRCs)Home & Community BasedService Providers (HCBS)Non Emergency MedicalTransportation (NMET)Psychiatric ResidentialTraining Facilities (PRTFs)Adult Day Care FacilitiesDirect Service Workers(DSWs)Home Health AgenciesNurse Aid Certification &TrainingRural Health ClinicsAdult Residential Care(ARCP)Elderly or Adult Abuse orNeglectHospicesNursing HomesSanction CollectionAmbulatory Surgical Centers(ASCs)Emergency MedicalTransportation (EMT)HospitalsOASISTherapeutic Group HomesBehavioral Health ServiceProviders (BHSPs)Emergency PreparednessInformal Dispute ResolutionOrgan ProcurementOrganizationsEnd Stage Dialysis Centers(ESRDs)Intermediate Care Facilityfor the DevelopmentalDisabled (ICF/DDs)Pain Management ClinicsFacility Need ReviewMedicaid Attendant Certified(MACs)Pediatric Day Health CareFacilitiesCase ManagementCLIA (Clinical LaboratoryImprovements Amendment)20

Health Standards SectionRural Health ClinicsBudget & WorkloadJune 6, 2018Jenny Haines and Debby FranklinMedical Certification Program Manager21

Budget & WorkloadA Real Balancing Act22

Budget & WorkloadThe FederalBudget CallLetteridentifiesthe priorities(tiers) of theStateworkload.23The federalfiscal yearruns fromOctober 1throughSeptember30

Priority Tiers Tiersreflect statutory mandates andprogram emphasis.Workload7060 States mustassure that Tiers 1 and 2will be completed as a pre-requisite toplanning for subsequent Tiers.504030Workload20100Tier Tier Tier Tier123424

Tier WorkloadTier 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.25

Tier WorkloadTier 3Complaint Surveys prioritized as non-Immediate Jeopardy Mediumcomplaints.Recertification Surveys on RHCs to ensure no more than 7 yearselapses between surveys.Tier 4Additional Recertification Surveys of non-accredited RHCs to ensurea 6 year average.Initial Certification Surveys of all RHCs since RHCs have the optionto achieve deemed Medicare status through an approved AO.Relocations of deemed providers.26

Tier WorkloadCMS is targeting national annual recertification coverage prioritiesfor the non-LTC providers including Rural Health Clinics.27

Accreditation & Deemed StatusSection 1865 (a) of the Act:Accredited hospitals are deemed to meet Medicare CoPsIFthe accrediting organization (AO) conducts a DEEMING survey of aRHC and the RHC can provide a copy of the survey report &approval letter indicating the deemed status.28

Deemed To MeetA successful accreditation survey means the RHC is deemed tomeet all Conditions for Coverage.29

Approved AOs for RHCsAmerican Association forAccreditation of AmbulatorySurgery Facilities (AAAASF)http://www.aaaasf.org/5101 Washington St., Suite2FP.O. Box 9500Gurnee, IL 600311-888-545-522230The Compliance Teamhttp://www.thecomplianceteam.org/905 Sheble Lane, Suite 102P.O. Box 160Springhouse, PA 19477Kate Hill: 1-215-654-9110khill@TheComplianceTeam.org

Federally Qualified Health Centers (FQHCs)Certification and recertification surveys are not required for FQHCs.However, CMS investigates complaints that make credibleallegations of substantial violations of CMS regulatory standards forFQHCs as a Tier 2 priority. States will use most of the same healthand safety standards as they do for RHCs when investigating FQHCcomplaints.31

Participation in Entirety AMedicare hospital must participate in its entirety.Selective participation of certain beds, units, campuses,services, etc, is not permitted. Even whereSSA permits certain exceptions, the exceptionsapply only to those distinct parts of an institution whichmay and do enter into a separate Medicare agreement(i.e. RHCs) Ifa hospital is going to have a RHC as an outpatient departmentof the hospital, the RHC must be certified.32

Health Standards SectionRural Health ClinicsLicensing & CertificationJune 6, 2018Jenny Haines & Debby FranklinMedical Certification Program Manager33

Licensing Standards34

DefinitionsRural Health Clinic (RHC) -anoutpatient primary care clinic seekingor possessing certificationby the Health Care FinancingAdministration (HCFA)(nowCMS) as a rural health clinic, whichprovides diagnosis andtreatment to the public by a qualifiedmid-level practitionerand a licensed physician35

*Licensing Standards* 7501– Definitions & Acronyms 7503– Licensing 7505– Denial, Revocation, or NonRenewal 7517 – PersonnelQualifications/Responsibilities 7519– Services 7521– Agency Operations 7507– Changes/Reporting 7523– Procedural Standards 7509– Annual Licensing Renewal 7525– Record Keeping 7511– Notice & Appeal Process 7529– Quality Assurance 7513– Complaint Process 7531 7515– Voluntary Cessation ofBusiness36– Patient’s Rights &Responsibilities 7533– Advisory Committee 7535– Physical Environment

Licensing AllRural Health Clinic’s, regardless of type, are licensed as RHC or anoffsite/department of the hospital Licensemust be displayed in an obvious place in the RHC at all times 2LicenseTypes: Full License: In substantial compliance with the rules, standards and law. These are issuedfor 12 months. Provisional License: Not in substantial compliance with the rules, standards and law. Thesecan be issued for up to 6 months if there is no immediate and serious threat to the health &safety of patients. (Very Seldom)37

License Notassignable or transferable Issued toa specific owner and to a specific geographic location. Immediately voided if VoidedRural Health Clinic ceases to operate or if its ownership changes.if the hospital (or off-site campus) relocates. The rural health clinic must notifyHSS at least fifteen days prior to any operationalchanges. RHCmust be open and operational prior to the licensing survey.38

3 Types of Rural Health Clinic’s1.Independent RHC – licensed and certifiedas a stand alone facility.2.Provider–Based RHC- licensed andcertified independently but CCN numberis linked to the hospital CCN number(should meet the provider based criteria).3.Hospital Department or Offsite- licensedto the hospital and certifiedindependently as a RHC (should meet theprovider based criteria).39

Only 1 LicenseA Rural Health Clinic can only be licensed as one type. The RHCcan’t have 2 or more licenses, i.e. it can’t be licensed as a freestanding RHC and a Hospital Outpatient Departmentsimultaneously.40

Independently Licensed RHC that isIndependently Certified as a RHC Has its own independent license which is not linkedwith any other facility type. Submits a Rural Health Clinic license application tobecome a licensed RHC (not a hospital licenseapplication) Submits a CMS 855A to become a certified RuralHealth Clinic and check off that it is enrolling as a“Rural Health Clinic” Not associated with a hospital.41

Independently Licensed RHC that isCertified as an Independent RHC butProvider Based to a Hospital Has its own independent license which is not linked with any otherfacility type. Submits a Rural Health Clinic license application to become a licensedRHC (not a hospital license application) Submits a CMS 855A to become a certified Rural Health Clinic, checkoff that it is enrolling as a “Rural Health Clinic” (not a hospital), andindicate that it will be provider based to the hospital. Associated with a Hospital Please keep in mind that this type must be able to demonstratecompliance with provider based requirements if asked by CMS42

Licensed as an Outpatient Department of aHospital, Certified as an Independent RHC butProvider Based to a Hospital Only hospitals with fewer than 50 beds can be considered for this option. This type will have a HOSPITAL license with “RHC” included in the licensenumber. Please remember that this type must demonstrate that it is 100%owned by the hospital and can’t operate separately from the hospital. Example:If the hospital closed, the RHC will automatically close. Submits a Hospital license application to become a licensed offsite campusoutpatient department of the hospital (not a Rural Health Clinic licenseapplication) Submits a CMS 855A to become a certified Rural Health Clinic, check off that it isenrolling as a “Rural Health Clinic” (not a hospital), and indicate that it will beprovider based to the hospital. (Do Not submit a CMS 855A to become apractice location of the hospital) Please keep in mind that this type must be able to demonstrate compliance withprovider based requirements if asked by CMS43

More Information Relative to HospitalOff-Site Campuses as it relates to RHCs Allpremises on which hospital services (inpatient and/oroutpatient) are provided and that are NOT adjoined to themain hospital buildings or grounds. State licensingpurposes within 50 miles of the main campusand in the state of Louisiana. If youparticipate in Medicare then the off-site campus mustbe within 35 miles of the main campus and in the state ofLouisiana. Provider-baseddesignation within 35 miles of the maincampus and in the state of Louisiana.44

Off-site Campuses Submit a Fee ofHospital Off-site RHC Application Packet 300.00 per off-site campus Submit CMS 855Ato enroll as a Rural Health Clinic (not as a practicelocation of the hospital) POPS is linked tothe Federal Aspen database and Health Standards isprohibited from making changes to the Federal system without theCMS 855A. Contact CMSfor provider-based designation45

Off-site CampusesMUSTS: MUST function under the same ownership structure as the maincampus MUST function under ONE governing body MUST function under ONE medical staff MUST function under ONE tax IDnumber MUST function under ONE unified medical record system MUST function under ONE organization-level policies MUST function under ONE nursing department MUST function under ONE quality assurance/performanceimprovement department MUST function under ONE infection control department46

Off-site CampusesMUST NOTS MUSTNOT have a different ownership structure than the maincampus MUSTNOT have a separate tax ID number from the main campus MUST NOT have independentcompliance at different locations.Non-compliance at one location equals non-compliance at alllocations47

Off-site Campuses Providersmust provide notice to CMS and the SA when plans aremade to add practice locations Inthe absence of notification of an expansion, CMS has theauthority to deny bills for services furnished at the expandedsite.48

ursTypeInitialLicensingLegal NameChangeRelocationKey PersonnelChangeConversionfrom HospitalOffsite toFree StandingLicenseRenewalDBA geConversionfrom FreeStanding rporateAddressChangeOther49

Initial Licensing & CertificationPacketsRHCs must be licensed in the state ofLouisiana(either independently or as an outpatientdepartment of a hospital)50

Initial Licensing & CertificationStep 1. Submit a Complete Licensing & Certification PacketLicensing Documents ForFree Standing RHCsLicensing Documents forHospital Offsite RHCsRHC License ApplicationHSS-HO-55 Offsite Addition and ChangesPayment of 600HSS-HO-017e Hospital Offsite Campus RHCAddition SupplementSite VerificationPayment of 300OSFM Plan Review(DH Plan Review)Site VerificationPlan Review AttestationOSFM Plan Review(DH Plan Review)OSFM Walk Through InspectionPlan Review AttestationOPH Walk Through InspectionOSFM Walk Through InspectionOwnership DiagramOPH Walk Through InspectionEP AttestationOwnership DiagramEP Attestation51

Initial Licensing & CertificationStep 1. Submit a Complete Licensing & Certification PacketLicensing PacketsMail to:Louisiana Department of HealthHealth Standards SectionATTN: RHCP.O. Box 3767Baton Rouge, LA 7082152Licensing PaymentsMail to:LDH Licensing FeeP.O. Box 62949New Orleans, LA 70162-2949

Initial Licensing & CertificationStep 1. Submit a Complete Licensing & Certification PacketCertification Documents forFree Standing RHCsCertification Documents forHospital Offsite RHCsApproved CMS 855A for the InitialEnrollment as a RHCApproved CMS 855A for the InitialEnrollment as a RHCCMS 29CMS 29CMS 1561ACMS 1561AOCR Clearance53

Initial Licensing & CertificationStep 1. Submit a Complete Licensing & Certification PacketEnrollmentTips to Facilitate the Medicare Enrollment ProcessConsider using PECOS (Provider Enrollment Chain &Ownership System)Submit the current version of the CMS 855AContact Information for Medicare AdministrativeContractors (MAC)Part A Contractor:Novitas SolutionsJH Provider Enrollment Services,P.O. Box 3095,Mechanicsburg, PA -8782, Option 4Medicare Enrollment Application for InstitutionalProvidersThis is the one for all hospital & Rural Health SForms/list.aspSubmit the correct application for your providertypeSubmit a complete applicationRequest & obtain your NPI number before enrollingor making a change in your Medicare enrollment infohttps://nppes.cms.hhs.gov/Submit the Electronic Funds Transfer AuthorizationAgreement (CMS-588) with your enrollment (ifapplicable).Submit all supporting documenta

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 9. Federal & State Relationship Section 1864 of the Social Security Act (the Act) establishes the framework within which State Agencies (SAs), under agre