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rmajette on DSK29S0YB1PROD with RULES2Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and RegulationsDEA Drug Enforcement AgencyDHUD Department of Housing and UrbanDevelopmentDME Durable medical equipmentDMEPOS Durable medical equipmentprosthetics, orthotics, and suppliesDOB Dates of birthDOJ Department of JusticeEIN Employer Identification NumberEMTALA Emergency Medical Treatmentand Active Labor ActVIN Vehicle Identifier NumberESRD End-stage renal diseaseEPLS General Service Administration’sExcluded Parties List SystemFBI Federal Bureau of InvestigationFFP Federal Financial ParticipationFFS Medicare fee-for-service programFQHC Federally qualified health centerGAO Government Accountability OfficeHHAs Home health agenciesHHS [Department of] Health and HumanServicesHIO Health insuring organizationIAFIS Integrated Automated FingerprintIdentification SystemICF/MR Intermediate care facilities forpersons with mental retardationIDTF Independent diagnostic testing facilityIHCIA Indian Health Care Improvement ActIHS Indian Health ServiceIHSS In-home supportive servicesIPF Inpatient psychiatric facilityIRF Inpatient rehabilitation facilityISDEAA Indian Self-Determination andEducation Assistance ActLEIE List of Excluded Individuals/EntitiesMCEs Managed care entitiesMFCU Medicaid fraud control unitMAO Medicare Advantage organizationsMMA Medicare Prescription Drug,Improvement, and Modernization Act of2003 (Pub. L. 108–173)NASDAQ National Association ofSecurities Dealers Automated QuotationSystemNF Nursing facilityNPI National Provider IdentifierNPPES National Plan and ProviderEnumeration SystemNSC National Supplier ClearinghouseNTIS National Technical InformationServiceNPDB National Practitioner Data BankNYSE New York Stock ExchangeOIG Office of Inspector GeneralOMB Office of Management and BudgetOPO Organ procurement organizationPAHP Prepaid ambulatory health planPECOS Provider Enrollment, Chain, andOwnership SystemPIHP Prepaid inpatient health planPSC Program Safeguard ContractorsPTAN Provider transaction account numberRFA Regulatory Flexibility ActRHC Rural health clinicRNHCI Religious nonmedical health careinstitutionSEC Securities and Exchange CommissionSMP Senior Medicare PatrolSNFs Skilled nursing facilitiesSPIA State Program Integrity AssessmentSSA Social Security AdministrationSSA DMF Social Security AdministrationDeath Master FileSSN Social Security NumberVerDate Mar 15 201015:39 Feb 01, 2011Jkt 223001TTAG Tribal Technical Advisory GroupWAN [FBI CJIS Division’s] Wide AreaNetworkZPIC Zone Program Integrity ContractorsTable of ContentsI. BackgroundII. Proposed Provisions and Responses toPublic CommentsA. Provider Screening Under Medicare,Medicaid, and CHIP1. Statutory Changes2. Summary of Existing ScreeningMeasuresa. Licensure Requirements—Medicare andMedicaidb. Site Visits—Medicarec. Database Checks—Medicared. Criminal Background Checks—Medicaree. Medicare MAO Requirementsf. Fingerprinting—Medicareg. Screening—Medicaid and CHIP3. General Screening of Providers—Medicarea. Proposed Screening Requirements(1) Limited(2) Moderate(3) Highb. Analysis of and Responses to PublicComment on Medicare ScreeningCategoriesc. Final Screening Provision—Medicare4. General Screening of Providers—Medicaid and CHIP: Proposed Provisionsand Analysis of and Responses to PublicCommentsa. Database Checks—Medicaid and CHIPb. Unscheduled and Unannounced SiteVisits—Medicaid and CHIPc. Provider Enrollment and ProviderTermination—Medicaid and CHIPd. Criminal Background Checks andFingerprinting—Medicaid and CHIPe. Deactivation and Reactivation ofProvider Enrollment—Medicaid andCHIPf. Enrollment and NPI of Ordering orReferring Providers—Medicaid and CHIPg. Other State Screening—Medicaid andCHIPh. Final Screening Provisions—Medicaidand CHIP5. Solicitation of Additional CommentsRegarding the Implementation of theFingerprinting RequirementsB. Application Fee—Medicare, Medicaid,and CHIP1. Statutory Changes2. Proposed Application Fee ProvisionsC. Temporary Moratoria on Enrollment ofMedicare Providers and Suppliers,Medicaid and CHIP Providers1. Statutory Changes2. Proposed Temporary MoratoriaProvisionsa. Medicareb. Medicaid and CHIP3. Analysis of and Responses to PublicComment4. Final Temporary Moratoria onEnrollment of Medicare Providers andSuppliers, Medicaid and CHIPProvisionsD. Suspension of Payments1. Medicarea. BackgroundPO 00000Frm 00003Fmt 4701Sfmt 47005863b. Previous Medicare Regulationsc. Proposed Medicare Suspension ofPayments Requirements2. Medicaida. Backgroundb. Previous Medicaid Regulationsc. Proposed Medicaid Suspension ofPayments RequirementsE. Proposed Approach and Solicitation ofComments for Sections 6102 and 6401(a)of the Affordable Care Act—Ethics andCompliance Program1. Statutory Changes2. Proposed Ethics and ComplianceProgram Provisions3. Analysis of and Responses to PublicComment4. Final Provisions—Ethics andCompliance ProgramF. Termination of Provider ParticipationUnder the Medicaid Program and CHIPif Terminated Under the MedicareProgram or Another State MedicaidProgram or CHIP1. Statutory Change2. Proposed Provisions for Termination ofProvider Participation Under theMedicaid Program and CHIP ifTerminated Under the Medicare Programor Another State Medicaid Program orCHIP3. Analysis of and Responses to PublicComment4. Final Provisions for Termination ofProvider Participation Under theMedicaid Program and CHIP ifTerminated Under the Medicare Programor Another State Medicaid Program orCHIPG. Additional Medicare ProviderEnrollment Provisions1. Statutory Changes2. Proposed Provisions for AdditionalMedicare Provider Enrollment3. Analysis of and Response to PublicComments4. Final Provisions for Additional MedicareProvider EnrollmentH. Technical and General CommentsIII. Collection of Information RequirementsA. ICRs Regarding Medicare ApplicationFee Hardship Exception (§ 424.514)B. ICRs Regarding Medicare FingerprintingRequirement (§ 424.518)C. ICRs Regarding Medicaid FingerprintingRequirement (§ 455.434)D. ICRs Regarding Suspension of Paymentsin Cases of Fraud or WillfulMisrepresentation (§ 455.23)E. ICRs Regarding Collection of SSNs andDOBs for Medicaid and CHIP providers(§ 455.104)F. ICRs Regarding Site Visits for MedicaidOnly or CHIP-Only Providers (§ 455.450)G. ICRs Regarding the Rescreening ofMedicaid Providers Every 5 Years(§ 455.414).IV. Response to CommentsV. Regulatory Impact AnalysisA. Statement of NeedB. Overall ImpactC. Anticipated Effects1. Medicarea. Enhanced Screening Procedures—Medicareb. Application Fee—MedicareE:\FR\FM\02FER2.SGM02FER2

5864Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulationsc. General Enrollment Framework(1) New Enrollment(2) Revalidation2. Medicaida. Enhanced Screening Proceduresb. Application Fee—Medicaidc. General Enrollment Framework(1) New Enrollments(2) Re-enrollment3. Medicare and Medicaida. Moratoria on Enrollment of NewMedicare Providers and Suppliers andMedicaid Providersb. Suspension of Payments in Medicareand MedicaidD. Accounting Statement and Table1. Medicare2. MedicaidE. Alternatives Considered1. General Burden Minimization Efforts2. Fingerprinting3. Other Suggested AlternativesF. ConclusionRegulations Textrmajette on DSK29S0YB1PROD with RULES2I. BackgroundThe Medicare program (title XVIII ofthe Social Security Act (the Act)) is theprimary payer of health care for 47million enrolled beneficiaries. Undersection 1802 of the Act, a beneficiarymay obtain health services from anindividual or an organization qualifiedto participate in the Medicare program.Qualifications to participate arespecified in statute and in regulations(see, for example, sections 1814, 1815,1819, 1833, 1834, 1842, 1861, 1866, and1891 of the Act; and 42 CFR Chapter IV,subchapter G, which concerns standardsand certification requirements).Providers and suppliers furnishingservices must comply with the Medicarerequirements stipulated in the Act andin our regulations. These requirementsare meant to ensure compliance withapplicable statutes, as well as topromote the furnishing of high qualitycare. As Medicare program expenditureshave grown, we have increased ourefforts to ensure that only qualifiedindividuals and organizations areallowed to enroll or maintain theirMedicare billing privileges.The Medicaid program (title XIX ofthe Act) is a joint Federal and Statehealth care program for eligible lowincome individuals providing coverageto more than 51 million people. Stateshave considerable flexibility in howthey administer their Medicaidprograms within a broad Federalframework and programs vary fromState to State.The Children’s Health InsuranceProgram (CHIP) (title XXI of the Act) isa joint Federal and State health careprogram that provides health carecoverage to more than 7.7 millionotherwise uninsured children.VerDate Mar 15 201015:39 Feb 01, 2011Jkt 223001Historically, States, in operatingMedicaid and CHIP, have permitted theenrollment of providers who meet theState requirements for programenrollment.The Patient Protection and AffordableCare Act (Pub. L. 111–148), as amendedby the Health Care and EducationReconciliation Act of 2010 (Pub. L. 111–152) (collectively known as theAffordable Care Act or ACA) makes anumber of changes to the Medicare andMedicaid programs and CHIP thatenhance the provider and supplierenrollment process to improve theintegrity of the programs to reducefraud, waste, and abuse in the programs.The following is an overview of someof the statutory authority relevant toenrollment in Medicare, Medicaid, andCHIP: Sections 1102 and 1871 of the Actprovide general authority for theSecretary of Health and Human Services(the Secretary) to prescribe regulationsfor the efficient administration of theMedicare program. Section 1102 of theAct also provides general authority forthe Secretary to prescribe regulations forthe efficient administration of theMedicaid program and CHIP. Section 4313 of the BalancedBudget Act of 1997 (BBA) (Pub. L. 105–33) amended sections 1124(a)(1) and1124A of the Act to require disclosureof both the Employer IdentificationNumber (EIN) and Social SecurityNumber (SSN) of each provider orsupplier, each person with ownership orcontrol interest in the provider orsupplier, any subcontractor in whichthe provider or supplier directly orindirectly has a 5 percent or moreownership interest, and any managingemployees including directors andofficers of corporations and non-profitorganizations and charities. The ‘‘Reportto Congress on Steps Taken to AssureConfidentiality of Social SecurityAccount Numbers as required by theBalanced Budget Act’’ was signed by theSecretary and sent to the Congress onJanuary 26, 1999. This report outlinesthe provisions of a mandatory collectionof SSNs and EINs effective on or afterApril 26, 1999. Section 936(a)(2) of the MedicarePrescription Drug, Improvement, andModernization Act of 2003 (MMA) (Pub.L. 108–173) amended the Act to requirethe Secretary to establish a process forthe enrollment of providers of servicesand suppliers. We are authorized tocollect information on the Medicareenrollment application (that is, theCMS–855, (Office of Management andBudget (OMB) approval number 0938–0685)) to ensure that correct paymentsare made to providers and suppliersPO 00000Frm 00004Fmt 4701Sfmt 4700under the Medicare program asestablished by title XVIII of the Act. Section 1902(a)(27) of the Actprovides general authority for theSecretary to require provider agreementsunder the Medicaid State Plans withevery person or institution providingservices under the State plan. Underthese agreements, the Secretary mayrequire information regarding anypayments claimed by such person orinstitution for providing services underthe State plan. Section 2107(e) of the Act, whichprovides that certain title XIX and titleXI provisions apply to States under titleXXI, including 1902(a)(4)(C) of the Act,relating to conflict of interest standards. Section 1903(i)(2) of the Actrelating to limitations on payment. Section 1124 of the Act relating todisclosure of ownership and relatedinformation. Sections 6401, 6402, 6501, and10603 of the ACA and 1304 of theHealth Care and EducationReconciliation Act (Pub. L. 111–152)amended the Act by establishing: (1)Procedures under which screening isconducted for providers of medical orother services and suppliers in theMedicare program, providers in theMedicaid program, and providers in theCHIP; (2) an application fee to beimposed on providers and suppliers; (3)temporary moratoria that the Secretarymay impose if necessary to prevent orcombat fraud, waste, and abuse underthe Medicare and Medicaid programsand CHIP; (4) requirements that StateMedicaid agencies must terminate anyprovider that is terminated by Medicareor another State plan; (5) requirementsfor suspensions of payments pendingcredible allegations of fraud in both theMedicare and Medicaid programs.II. Proposed Provisions and Responsesto Public CommentsWe received approximately 300timely pieces of correspondencecontaining multiple comments on theAdditional Screening Requirements,Application Fees, TemporaryEnrollment Moratoria, PaymentSuspensions and Compliance Plans forProviders and Suppliers proposed rulepublished September 23, 2010 (75 FR58204). We note that we received somecomments that were outside the scopeof the proposed rule. These commentsare not addressed in this final rule withcomment period. Summaries of thepublic comments that are within thescope of the proposals and ourresponses to those comments are setforth in the various sections of this finalrule with comment period under theappropriate headings.E:\FR\FM\02FER2.SGM02FER2

Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and RegulationsA. Provider Screening Under Medicare,Medicaid, and CHIPrmajette on DSK29S0YB1PROD with RULES21. Statutory ChangesSection 6401(a) of the ACA, asamended by section 10603 of the ACA,amends section 1866(j) of the Act to adda new paragraph, paragraph ‘‘(2)Provider Screening.’’ Section1866(j)(2)(A) of the Act requires theSecretary, in consultation with theDepartment of Health of HumanServices’ Office of the Inspector General(HHS OIG), to establish proceduresunder which screening is conductedwith respect to providers of medical orother items or services and suppliersunder Medicare, Medicaid, and CHIP.Section 1866(j)(2)(B) of the Act requiresthe Secretary to determine the level ofscreening to be conducted according tothe risk of fraud, waste, and abuse withrespect to the category of provider ofmedical or other items or services orsupplier. The provision states that thescreening shall include a licensurecheck, which may include such checksacross State lines; and the screeningmay, as the Secretary determinesappropriate based on the risk of fraud,waste, and abuse, include a criminalbackground check; fingerprinting;unscheduled or unannounced site visits,including pre-enrollment site visits;database checks, including such checksacross State lines; and such otherscreening as the Secretary determinesappropriate. Section 1866(j)(2)(C) of theAct requires the Secretary to impose afee on each institutional provider ofmedical or other items or services orsupplier that would be used by theSecretary for program integrity effortsincluding to cover the cost of screeningand to carry out the provisions ofsections 1866(j) and 1128J of the Act.We discussed the fee in section II.B. ofthe proposed rule.Section 6401(b) of the ACA amendssection 1902 of the Act to add newparagraph (a)(77) and (ii), whichrequires States to comply with theprocess for screening providers andsuppliers as established by the Secretaryunder 1866(j)(2) of the Act.1 Note thatsection 6401(b) of the ACA erroneouslyadded a duplicate section 1902(ii) to the1 We believe that the reference to section1886(j)(2) of the Act in section 6401(b)(1) of theACA is a scrivener’s error. We believe the Congressintended to refer to section 1866(j)(2) of the Act,which, as amended by section 6401(a) of the ACA,requires the Secretary to establish a process forscreening providers and suppliers. Because thedrafting error is apparent, and a literal reading ofthe reference to section 1886(j)(2) of the Act wouldproduce absurd results, we interpret the crossreference to section 1886(j)(2) in the new section1902(kk) of the Act as if the reference were tosection 1866(j)(2).VerDate Mar 15 201015:39 Feb 01, 2011Jkt 223001Act. Therefore, in the Medicare andMedicaid Extenders Act of 2010 (Pub. L.111–309), the Congress enacted atechnical correction to redesignate thesection 1902(ii) of the Act added bysection 6401(b) of ACA as section1902(kk) of the Act. In this regulation,we therefore reference section 1902(kk)of the Act when referring to theprovisions added by section 6401(b) ofthe ACA.We noted in the proposed rule thatthe statute uses the terms ‘‘providers ofmedical or other items or services,’’‘‘institutional providers,’’ and‘‘suppliers.’’ The Medicare programenrolls a variety of providers andsuppliers, some of which are referred toas ‘‘providers of services,’’ ‘‘institutionalproviders,’’ ‘‘certified providers,’’‘‘certified suppliers,’’ and ‘‘suppliers.’’ InMedicare, the term ‘‘providers ofservices’’ under section 1861(u) of theAct means health care entities thatfurnish services primarily payableunder Part A of Medicare, such ashospitals, home health agencies(including home health agenciesproviding services under Part B),hospices, and skilled nursing facilities.The term ‘‘suppliers’’ defined in section1861(d) of the Act refers to health careentities that furnish services primarilypayable under Part B of Medicare, suchas independent diagnostic testingfacilities (IDTFs), durable medicalequipment prosthetics, orthotics, andsupplies (DMEPOS) suppliers, andeligible professionals, which refers tohealth care suppliers who areindividuals, that is, physicians and theother professionals listed in section1848(k)(3)(B) of the Act. For Medicaidand CHIP, we use the terms ‘‘providers’’or ‘‘Medicaid providers’’ or ‘‘CHIPproviders’’ when referring to allMedicaid or CHIP health care providers,including individual practitioners,institutional providers, and providers ofmedical equipment or goods related tocare. The term ‘‘supplier’’ has nomeaning in the Medicaid program orCHIP.The new screening proceduresimplemented pursuant to new section1866(j)(2) of the Act are applicable tonewly enrolling providers andsuppliers, including eligibleprofessionals, beginning on March 25,2011. These new procedures areapplicable to currently enrolledMedicare, Medicaid, and CHIPproviders, suppliers, and eligibleprofessionals beginning on March 23,2012. These new screening proceduresimplemented pursuant to new section1866(j)(2) of the Act are applicablebeginning on March 25, 2011 for thoseproviders and suppliers currentlyPO 00000Frm 00005Fmt 4701Sfmt 47005865enrolled in Medicare, Medicaid, andCHIP who revalidate their enrollmentinformation. Within Medicare, theMarch 25, 2011 implementation datewill impact those current providers andsuppliers whose 5-year revalidationcycle (or 3-year revalidation cycle forDMEPOS suppliers) results inrevalidation occurring on or after March25, 2011 and before March 23, 2012.The requirements for revalidation arediscussed in § 424.515. It is important tonote that revalidation—for purposes ofboth provider enrollment in general andthis final rule with comment period—does not include routine changes ofinformation as described in § 424.516(d)and (e), such as address changes orchanges in phone number.2. Summary of Existing ScreeningMeasuresBefore we outline the new measureswe are finalizing under the ACA, it maybe helpful to provide a summary ofsome of the screening measures alreadybeing utilized in Medicare, Medicaid,and CHIP. Pursuant to other authority,but with the notable exception ofbackground checks and fingerprinting,Medicare, generally through privatecontractors, already employs a numberof the screening practices described insection 1866(j)(2)(B) of the Act todetermine if a provider or supplier is incompliance with Federal and Staterequirements to enroll or to maintainenrollment in the Medicare program.We also believe it important to notethat nothing in this rule is intended toabridge our established screeningauthority under existing statutes andregulations or to diminish the screeningthat providers and suppliers currentlyundergo. To the contrary; the provisionsspecified in this final rule withcomment period are intended toenhance our existing authority. Thisrule’s provisions, in other words, set‘‘floors’’—not ceilings—on enrollmentrequirements for each screening level.a. Licensure Requirements—Medicareand MedicaidOver the past several years, we havetaken a number of steps to strengthenour ability to deny or revoke Medicarebilling privileges when providers orsuppliers do not have or do notmaintain the applicable State licensurerequirements for their provider orsupplier type or profession. Weestablished reporting responsibilities forall providers, suppliers, and eligibleprofessionals in earlier regulations at§ 424.516(b) through (e). To ensure thatonly qualified providers and suppliersremain in the Medicare fee-for-service(FFS) program, we require that MedicareE:\FR\FM\02FER2.SGM02FER2

5866Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulationsrmajette on DSK29S0YB1PROD with RULES2contractors review State licensing boarddata on a monthly basis to determine ifproviders and suppliers remain incompliance with State licensurerequirements. Medicare billingprivileges would be revoked for thoseproviders and suppliers who do notreport a final adverse action (forexample, license revocation orsuspension, felony conviction) withinthe applicable reporting period, asrequired in § 424.516(b) through (e).Medicare suppliers of DMEPOS andIDTFs are already subject to similarprovisions in § 424.57(c) and§ 410.33(g), respectively. DMEPOSsuppliers are also subject to additionalrequirements including accreditationand surety bonding, pursuant to§ 424.57(c)(22) through (26) and§ 424.57(d).Medicare Advantage organizations(MAOs) are required to verify licensureof providers and suppliers, includingphysicians and other health careprofessionals, in accordance with§ 422.204.For Medicaid and CHIP, most Statesdo some checking of in-State providerlicenses, but the extent of scrutinyvaries. For example, in some States, theexistence of the license may be verified,but little attention might be given to anyrestrictions on the license.b. Site Visits—MedicarePursuant to § 424.517, Medicareconducts the following site visits andtakes the following actions, generallythrough private contractors under CMSdirection: The National Supp

I. Background II. Proposed Provisions and Responses to Public Comments A. Provider Screening Under Medicare, Medicaid, and CHIP 1. Statutory Changes 2. Summary of Existing Screening Measures a. Licensure Requirements—Medicare and Medicaid b. Site Visits—Medicare c. Database Checks—Medicare d. Criminal Background Checks—Medicare e.