Title 42

Volume 5 CHAPTER IV SUBCHAP G

Subchapter G - Standards And Certification

42:5.0.1.1.1PART 482
PART 482 - CONDITIONS OF PARTICIPATION FOR HOSPITALS
42:5.0.1.1.1.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.1.1.4.1SECTION 482.1
     482.1 Basis and scope.
42:5.0.1.1.1.1.4.2SECTION 482.2
     482.2 Provision of emergency services by nonparticipating hospitals.
42:5.0.1.1.1.2SUBPART B
Subpart B - Administration
42:5.0.1.1.1.2.4.1SECTION 482.11
     482.11 Condition of participation: Compliance with Federal, State and local laws.
42:5.0.1.1.1.2.4.2SECTION 482.12
     482.12 Condition of participation: Governing body.
42:5.0.1.1.1.2.4.3SECTION 482.13
     482.13 Condition of participation: Patient's rights.
42:5.0.1.1.1.2.4.4SECTION 482.15
     482.15 Condition of participation: Emergency preparedness.
42:5.0.1.1.1.3SUBPART C
Subpart C - Basic Hospital Functions
42:5.0.1.1.1.3.4.1SECTION 482.21
     482.21 Condition of participation: Quality assessment and performance improvement program.
42:5.0.1.1.1.3.4.2SECTION 482.22
     482.22 Condition of participation: Medical staff.
42:5.0.1.1.1.3.4.3SECTION 482.23
     482.23 Condition of participation: Nursing services.
42:5.0.1.1.1.3.4.4SECTION 482.24
     482.24 Condition of participation: Medical record services.
42:5.0.1.1.1.3.4.5SECTION 482.25
     482.25 Condition of participation: Pharmaceutical services.
42:5.0.1.1.1.3.4.6SECTION 482.26
     482.26 Condition of participation: Radiologic services.
42:5.0.1.1.1.3.4.7SECTION 482.27
     482.27 Condition of participation: Laboratory services.
42:5.0.1.1.1.3.4.8SECTION 482.28
     482.28 Condition of participation: Food and dietetic services.
42:5.0.1.1.1.3.4.9SECTION 482.30
     482.30 Condition of participation: Utilization review.
42:5.0.1.1.1.3.4.10SECTION 482.41
     482.41 Condition of participation: Physical environment.
42:5.0.1.1.1.3.4.11SECTION 482.42
     482.42 Condition of participation: Infection prevention and control and antibiotic stewardship programs.
42:5.0.1.1.1.3.4.12SECTION 482.43
     482.43 Condition of participation: Discharge planning.
42:5.0.1.1.1.3.4.13SECTION 482.45
     482.45 Condition of participation: Organ, tissue, and eye procurement.
42:5.0.1.1.1.4SUBPART D
Subpart D - Optional Hospital Services
42:5.0.1.1.1.4.4.1SECTION 482.51
     482.51 Condition of participation: Surgical services.
42:5.0.1.1.1.4.4.2SECTION 482.52
     482.52 Condition of participation: Anesthesia services.
42:5.0.1.1.1.4.4.3SECTION 482.53
     482.53 Condition of participation: Nuclear medicine services.
42:5.0.1.1.1.4.4.4SECTION 482.54
     482.54 Condition of participation: Outpatient services.
42:5.0.1.1.1.4.4.5SECTION 482.55
     482.55 Condition of participation: Emergency services.
42:5.0.1.1.1.4.4.6SECTION 482.56
     482.56 Condition of participation: Rehabilitation services.
42:5.0.1.1.1.4.4.7SECTION 482.57
     482.57 Condition of participation: Respiratory care services.
42:5.0.1.1.1.4.4.8SECTION 482.58
     482.58 Special requirements for hospital providers of long-term care services (“swing-beds”).
42:5.0.1.1.1.5SUBPART E
Subpart E - Requirements for Specialty Hospitals
42:5.0.1.1.1.5.4SUBJGRP 4
  General Requirements for Transplant Centers
42:5.0.1.1.1.5.4.1SECTION 482.60
     482.60 Special provisions applying to psychiatric hospitals.
42:5.0.1.1.1.5.4.2SECTION 482.61
     482.61 Condition of participation: Special medical record requirements for psychiatric hospitals.
42:5.0.1.1.1.5.4.3SECTION 482.62
     482.62 Condition of participation: Special staff requirements for psychiatric hospitals.
42:5.0.1.1.1.5.4.4SECTION 482.68
     482.68 Special requirement for transplant programs.
42:5.0.1.1.1.5.4.5SECTION 482.70
     482.70 Definitions.
42:5.0.1.1.1.5.4.6SECTION 482.72
     482.72 Condition of participation: OPTN membership.
42:5.0.1.1.1.5.4.7SECTION 482.74
     482.74 Condition of participation: Notification to CMS.
42:5.0.1.1.1.5.4.8SECTION 482.76
     482.76 Condition of participation: Pediatric Transplants.
42:5.0.1.1.1.5.4.9SECTION 482.78
     482.78 Condition of participation: Emergency preparedness for transplant programs.
42:5.0.1.1.1.5.5SUBJGRP 5
  Transplant Center Data Submission, Clinical Experience, and Outcome Requirements
42:5.0.1.1.1.5.5.10SECTION 482.80
     482.80 Condition of participation: Data submission, clinical experience, and outcome requirements for initial approval of transplant programs.
42:5.0.1.1.1.5.6SUBJGRP 6
  Transplant Program Process Requirements
42:5.0.1.1.1.5.6.11SECTION 482.90
     482.90 Condition of participation: Patient and living donor selection.
42:5.0.1.1.1.5.6.12SECTION 482.92
     482.92 Condition of participation: Organ recovery and receipt.
42:5.0.1.1.1.5.6.13SECTION 482.94
     482.94 Condition of participation: Patient and living donor management.
42:5.0.1.1.1.5.6.14SECTION 482.96
     482.96 Condition of participation: Quality assessment and performance improvement (QAPI).
42:5.0.1.1.1.5.6.15SECTION 482.98
     482.98 Condition of participation: Human resources.
42:5.0.1.1.1.5.6.16SECTION 482.100
     482.100 Condition of participation: Organ procurement.
42:5.0.1.1.1.5.6.17SECTION 482.102
     482.102 Condition of participation: Patient and living donor rights.
42:5.0.1.1.1.5.6.18SECTION 482.104
     482.104 Condition of participation: Additional requirements for kidney transplant programs.
42:5.0.1.1.2PART 483
PART 483 - REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
42:5.0.1.1.2.1SUBPART A
Subpart A [Reserved]
42:5.0.1.1.2.2SUBPART B
Subpart B - Requirements for Long Term Care Facilities
42:5.0.1.1.2.2.7.1SECTION 483.1
     483.1 Basis and scope.
42:5.0.1.1.2.2.7.2SECTION 483.5
     483.5 Definitions.
42:5.0.1.1.2.2.7.3SECTION 483.10
     483.10 Resident rights.
42:5.0.1.1.2.2.7.4SECTION 483.12
     483.12 Freedom from abuse, neglect, and exploitation.
42:5.0.1.1.2.2.7.5SECTION 483.15
     483.15 Admission, transfer, and discharge rights.
42:5.0.1.1.2.2.7.6SECTION 483.20
     483.20 Resident assessment.
42:5.0.1.1.2.2.7.7SECTION 483.21
     483.21 Comprehensive person-centered care planning.
42:5.0.1.1.2.2.7.8SECTION 483.24
     483.24 Quality of life.
42:5.0.1.1.2.2.7.9SECTION 483.25
     483.25 Quality of care.
42:5.0.1.1.2.2.7.10SECTION 483.30
     483.30 Physician services.
42:5.0.1.1.2.2.7.11SECTION 483.35
     483.35 Nursing services.
42:5.0.1.1.2.2.7.12SECTION 483.40
     483.40 Behavioral health services.
42:5.0.1.1.2.2.7.13SECTION 483.45
     483.45 Pharmacy services.
42:5.0.1.1.2.2.7.14SECTION 483.50
     483.50 Laboratory, radiology, and other diagnostic services.
42:5.0.1.1.2.2.7.15SECTION 483.55
     483.55 Dental services.
42:5.0.1.1.2.2.7.16SECTION 483.60
     483.60 Food and nutrition services.
42:5.0.1.1.2.2.7.17SECTION 483.65
     483.65 Specialized rehabilitative services.
42:5.0.1.1.2.2.7.18SECTION 483.70
     483.70 Administration.
42:5.0.1.1.2.2.7.19SECTION 483.73
     483.73 Emergency preparedness.
42:5.0.1.1.2.2.7.20SECTION 483.75
     483.75 Quality assurance and performance improvement.
42:5.0.1.1.2.2.7.21SECTION 483.80
     483.80 Infection control.
42:5.0.1.1.2.2.7.22SECTION 483.85
     483.85 Compliance and ethics program.
42:5.0.1.1.2.2.7.23SECTION 483.90
     483.90 Physical environment.
42:5.0.1.1.2.2.7.24SECTION 483.95
     483.95 Training requirements.
42:5.0.1.1.2.3SUBPART C
Subpart C - Preadmission Screening and Annual Review of Mentally Ill and Mentally Retarded Individuals
42:5.0.1.1.2.3.7.1SECTION 483.100
     483.100 Basis.
42:5.0.1.1.2.3.7.2SECTION 483.102
     483.102 Applicability and definitions.
42:5.0.1.1.2.3.7.3SECTION 483.104
     483.104 State plan requirement.
42:5.0.1.1.2.3.7.4SECTION 483.106
     483.106 Basic rule.
42:5.0.1.1.2.3.7.5SECTION 483.108
     483.108 Relationship of PASARR to other Medicaid processes.
42:5.0.1.1.2.3.7.6SECTION 483.110
     483.110 Out-of-State arrangements.
42:5.0.1.1.2.3.7.7SECTION 483.112
     483.112 Preadmission screening of applicants for admission to NFs.
42:5.0.1.1.2.3.7.8SECTION 483.114
     483.114 Annual review of NF residents.
42:5.0.1.1.2.3.7.9SECTION 483.116
     483.116 Residents and applicants determined to require NF level of services.
42:5.0.1.1.2.3.7.10SECTION 483.118
     483.118 Residents and applicants determined not to require NF level of services.
42:5.0.1.1.2.3.7.11SECTION 483.120
     483.120 Specialized services.
42:5.0.1.1.2.3.7.12SECTION 483.122
     483.122 FFP for NF services.
42:5.0.1.1.2.3.7.13SECTION 483.124
     483.124 FFP for specialized services.
42:5.0.1.1.2.3.7.14SECTION 483.126
     483.126 Appropriate placement.
42:5.0.1.1.2.3.7.15SECTION 483.128
     483.128 PASARR evaluation criteria.
42:5.0.1.1.2.3.7.16SECTION 483.130
     483.130 PASARR determination criteria.
42:5.0.1.1.2.3.7.17SECTION 483.132
     483.132 Evaluating the need for NF services and NF level of care (PASARR/NF).
42:5.0.1.1.2.3.7.18SECTION 483.134
     483.134 Evaluating whether an individual with mental illness requires specialized services (PASARR/MI).
42:5.0.1.1.2.3.7.19SECTION 483.136
     483.136 Evaluating whether an individual with intellectual disability requires specialized services (PASARR/IID).
42:5.0.1.1.2.3.7.20SECTION 483.138
     483.138 Maintenance of services and availability of FFP.
42:5.0.1.1.2.4SUBPART D
Subpart D - Requirements That Must Be Met by States and State Agencies: Nurse Aide Training and Competency Evaluation, and Paid Feeding Assistants
42:5.0.1.1.2.4.7.1SECTION 483.150
     483.150 Statutory basis; Deemed meeting or waiver of requirements.
42:5.0.1.1.2.4.7.2SECTION 483.151
     483.151 State review and approval of nurse aide training and competency evaluation programs.
42:5.0.1.1.2.4.7.3SECTION 483.152
     483.152 Requirements for approval of a nurse aide training and competency evaluation program.
42:5.0.1.1.2.4.7.4SECTION 483.154
     483.154 Nurse aide competency evaluation.
42:5.0.1.1.2.4.7.5SECTION 483.156
     483.156 Registry of nurse aides.
42:5.0.1.1.2.4.7.6SECTION 483.158
     483.158 FFP for nurse aide training and competency evaluation.
42:5.0.1.1.2.4.7.7SECTION 483.160
     483.160 Requirements for training of paid feeding assistants.
42:5.0.1.1.2.5SUBPART E
Subpart E - Appeals of Discharges, Transfers, and Preadmission Screening and Annual Resident Review (PASARR) Determinations
42:5.0.1.1.2.5.7.1SECTION 483.200
     483.200 Statutory basis.
42:5.0.1.1.2.5.7.2SECTION 483.202
     483.202 Definitions.
42:5.0.1.1.2.5.7.3SECTION 483.204
     483.204 Provision of a hearing and appeal system.
42:5.0.1.1.2.5.7.4SECTION 483.206
     483.206 Transfers, discharges and relocations subject to appeal.
42:5.0.1.1.2.6SUBPART F
Subpart F - Requirements That Must be Met by States and State Agencies, Resident Assessment
42:5.0.1.1.2.6.7.1SECTION 483.315
     483.315 Specification of resident assessment instrument.
42:5.0.1.1.2.7SUBPART G
Subpart G - Condition of Participation for the Use of Restraint or Seclusion in Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21
42:5.0.1.1.2.7.7.1SECTION 483.350
     483.350 Basis and scope.
42:5.0.1.1.2.7.7.2SECTION 483.352
     483.352 Definitions.
42:5.0.1.1.2.7.7.3SECTION 483.354
     483.354 General requirements for psychiatric residential treatment facilities.
42:5.0.1.1.2.7.7.4SECTION 483.356
     483.356 Protection of residents.
42:5.0.1.1.2.7.7.5SECTION 483.358
     483.358 Orders for the use of restraint or seclusion.
42:5.0.1.1.2.7.7.6SECTION 483.360
     483.360 Consultation with treatment team physician.
42:5.0.1.1.2.7.7.7SECTION 483.362
     483.362 Monitoring of the resident in and immediately after restraint.
42:5.0.1.1.2.7.7.8SECTION 483.364
     483.364 Monitoring of the resident in and immediately after seclusion.
42:5.0.1.1.2.7.7.9SECTION 483.366
     483.366 Notification of parent(s) or legal guardian(s).
42:5.0.1.1.2.7.7.10SECTION 483.368
     483.368 Application of time out.
42:5.0.1.1.2.7.7.11SECTION 483.370
     483.370 Postintervention debriefings.
42:5.0.1.1.2.7.7.12SECTION 483.372
     483.372 Medical treatment for injuries resulting from an emergency safety intervention.
42:5.0.1.1.2.7.7.13SECTION 483.374
     483.374 Facility reporting.
42:5.0.1.1.2.7.7.14SECTION 483.376
     483.376 Education and training.
42:5.0.1.1.2.8SUBPART H
Subpart H [Reserved]
42:5.0.1.1.2.9SUBPART I
Subpart I - Conditions of Participation for Intermediate Care Facilities for Individuals with Intellectual Disabilities
42:5.0.1.1.2.9.7.1SECTION 483.400
     483.400 Basis and purpose.
42:5.0.1.1.2.9.7.2SECTION 483.405
     483.405 Relationship to other HHS regulations.
42:5.0.1.1.2.9.7.3SECTION 483.410
     483.410 Condition of participation: Governing body and management.
42:5.0.1.1.2.9.7.4SECTION 483.420
     483.420 Condition of participation: Client protections.
42:5.0.1.1.2.9.7.5SECTION 483.430
     483.430 Condition of participation: Facility staffing.
42:5.0.1.1.2.9.7.6SECTION 483.440
     483.440 Condition of participation: Active treatment services.
42:5.0.1.1.2.9.7.7SECTION 483.450
     483.450 Condition of participation: Client behavior and facility practices.
42:5.0.1.1.2.9.7.8SECTION 483.460
     483.460 Condition of participation: Health care services.
42:5.0.1.1.2.9.7.9SECTION 483.470
     483.470 Condition of participation: Physical environment.
42:5.0.1.1.2.9.7.10SECTION 483.475
     483.475 Condition of participation: Emergency preparedness.
42:5.0.1.1.2.9.7.11SECTION 483.480
     483.480 Condition of participation: Dietetic services.
42:5.0.1.1.3PART 484
PART 484 - HOME HEALTH SERVICES
42:5.0.1.1.3.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.3.1.7.1SECTION 484.1
     484.1 Basis and scope.
42:5.0.1.1.3.1.7.2SECTION 484.2
     484.2 Definitions.
42:5.0.1.1.3.2SUBPART B
Subpart B - Patient Care
42:5.0.1.1.3.2.7.1SECTION 484.40
     484.40 Condition of participation: Release of patient identifiable OASIS information.
42:5.0.1.1.3.2.7.2SECTION 484.45
     484.45 Condition of participation: Reporting OASIS information.
42:5.0.1.1.3.2.7.3SECTION 484.50
     484.50 Condition of participation: Patient rights.
42:5.0.1.1.3.2.7.4SECTION 484.55
     484.55 Condition of participation: Comprehensive assessment of patients.
42:5.0.1.1.3.2.7.5SECTION 484.58
     484.58 Condition of participation: Discharge planning.
42:5.0.1.1.3.2.7.6SECTION 484.60
     484.60 Condition of participation: Care planning, coordination of services, and quality of care.
42:5.0.1.1.3.2.7.7SECTION 484.65
     484.65 Condition of participation: Quality assessment and performance improvement (QAPI).
42:5.0.1.1.3.2.7.8SECTION 484.70
     484.70 Condition of participation: Infection prevention and control.
42:5.0.1.1.3.2.7.9SECTION 484.75
     484.75 Condition of participation: Skilled professional services.
42:5.0.1.1.3.2.7.10SECTION 484.80
     484.80 Condition of participation: Home health aide services.
42:5.0.1.1.3.3SUBPART C
Subpart C - Organizational Environment
42:5.0.1.1.3.3.7.1SECTION 484.100
     484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients.
42:5.0.1.1.3.3.7.2SECTION 484.102
     484.102 Condition of participation: Emergency preparedness.
42:5.0.1.1.3.3.7.3SECTION 484.105
     484.105 Condition of participation: Organization and administration of services.
42:5.0.1.1.3.3.7.4SECTION 484.110
     484.110 Condition of participation: Clinical records.
42:5.0.1.1.3.3.7.5SECTION 484.115
     484.115 Condition of participation: Personnel qualifications.
42:5.0.1.1.3.4SUBPART D
Subpart D [Reserved]
42:5.0.1.1.3.5SUBPART E
Subpart E - Prospective Payment System for Home Health Agencies
42:5.0.1.1.3.5.7.1SECTION 484.200
     484.200 Basis and scope.
42:5.0.1.1.3.5.7.2SECTION 484.202
     484.202 Definitions.
42:5.0.1.1.3.5.7.3SECTION 484.205
     484.205 Basis of payment.
42:5.0.1.1.3.5.7.4SECTION 484.215
     484.215 Initial establishment of the calculation of the national, standardized prospective payment rates.
42:5.0.1.1.3.5.7.5SECTION 484.220
     484.220 Calculation of the case-mix and wage area adjusted prospective payment rates.
42:5.0.1.1.3.5.7.6SECTION 484.225
     484.225 Annual update of the unadjusted national, standardized prospective payment rates.
42:5.0.1.1.3.5.7.7SECTION 484.230
     484.230 Low-utilization payment adjustments.
42:5.0.1.1.3.5.7.8SECTION 484.235
     484.235 Partial payment adjustments.
42:5.0.1.1.3.5.7.9SECTION 484.240
     484.240 Outlier payments.
42:5.0.1.1.3.5.7.10SECTION 484.245
     484.245 Requirements under the Home Health Quality Reporting Program (HH QRP).
42:5.0.1.1.3.5.7.11SECTION 484.250
     484.250 OASIS data.
42:5.0.1.1.3.5.7.12SECTION 484.260
     484.260 Limitation on review.
42:5.0.1.1.3.5.7.13SECTION 484.265
     484.265 Additional payment.
42:5.0.1.1.3.6SUBPART F
Subpart F - Home Health Value-Based Purchasing (HHVBP) Model Components for Competing Home Health Agencies Within State Boundaries
42:5.0.1.1.3.6.7.1SECTION 484.300
     484.300 Basis and scope of subpart.
42:5.0.1.1.3.6.7.2SECTION 484.305
     484.305 Definitions.
42:5.0.1.1.3.6.7.3SECTION 484.310
     484.310 Applicability of the Home Health Value-Based Purchasing (HHVBP) Model.
42:5.0.1.1.3.6.7.4SECTION 484.315
     484.315 Data reporting for measures and evaluation and the public reporting of model data under the Home Health Value-Based Purchasing (HHVBP) Model.
42:5.0.1.1.3.6.7.5SECTION 484.320
     484.320 Calculation of the Total Performance Score.
42:5.0.1.1.3.6.7.6SECTION 484.325
     484.325 Payments for home health services under Home Health Value-Based Purchasing (HHVBP) Model.
42:5.0.1.1.3.6.7.7SECTION 484.330
     484.330 Process for determining and applying the value-based payment adjustment under the Home Health Value-Based Purchasing (HHVBP) Model.
42:5.0.1.1.3.6.7.8SECTION 484.335
     484.335 Appeals process for the Home Health Value-Based Purchasing (HHVBP) Model.
42:5.0.1.1.4PART 485
PART 485 - CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
42:5.0.1.1.4.1SUBPART A
Subpart A [Reserved]
42:5.0.1.1.4.2SUBPART B
Subpart B - Conditions of Participation: Comprehensive Outpatient Rehabilitation Facilities
42:5.0.1.1.4.2.7.1SECTION 485.50
     485.50 Basis and scope.
42:5.0.1.1.4.2.7.2SECTION 485.51
     485.51 Definition.
42:5.0.1.1.4.2.7.3SECTION 485.54
     485.54 Condition of participation: Compliance with State and local laws.
42:5.0.1.1.4.2.7.4SECTION 485.56
     485.56 Condition of participation: Governing body and administration.
42:5.0.1.1.4.2.7.5SECTION 485.58
     485.58 Condition of participation: Comprehensive rehabilitation program.
42:5.0.1.1.4.2.7.6SECTION 485.60
     485.60 Condition of participation: Clinical records.
42:5.0.1.1.4.2.7.7SECTION 485.62
     485.62 Condition of participation: Physical environment.
42:5.0.1.1.4.2.7.8SECTION 485.64
     485.64 [Reserved]
42:5.0.1.1.4.2.7.9SECTION 485.66
     485.66 Condition of participation: Utilization review plan.
42:5.0.1.1.4.2.7.10SECTION 485.68
     485.68 Condition of participation: Emergency preparedness.
42:5.0.1.1.4.2.7.11SECTION 485.70
     485.70 Personnel qualifications.
42:5.0.1.1.4.2.7.12SECTION 485.74
     485.74 Appeal rights.
42:5.0.1.1.4.3SUBPART C
Subparts C-E [Reserved]
42:5.0.1.1.4.4SUBPART F
Subpart F - Conditions of Participation: Critical Access Hospitals (CAHs)
42:5.0.1.1.4.4.7.1SECTION 485.601
     485.601 Basis and scope.
42:5.0.1.1.4.4.7.2SECTION 485.603
     485.603 Rural health network.
42:5.0.1.1.4.4.7.3SECTION 485.604
     485.604 Personnel qualifications.
42:5.0.1.1.4.4.7.4SECTION 485.606
     485.606 Designation and certification of CAHs.
42:5.0.1.1.4.4.7.5SECTION 485.608
     485.608 Condition of participation: Compliance with Federal, State, and local laws and regulations.
42:5.0.1.1.4.4.7.6SECTION 485.610
     485.610 Condition of participation: Status and location.
42:5.0.1.1.4.4.7.7SECTION 485.612
     485.612 Condition of participation: Compliance with hospital requirements at the time of application.
42:5.0.1.1.4.4.7.8SECTION 485.616
     485.616 Condition of participation: Agreements.
42:5.0.1.1.4.4.7.9SECTION 485.618
     485.618 Condition of participation: Emergency services.
42:5.0.1.1.4.4.7.10SECTION 485.620
     485.620 Condition of participation: Number of beds and length of stay.
42:5.0.1.1.4.4.7.11SECTION 485.623
     485.623 Condition of participation: Physical plant and environment.
42:5.0.1.1.4.4.7.12SECTION 485.625
     485.625 Condition of participation: Emergency preparedness.
42:5.0.1.1.4.4.7.13SECTION 485.627
     485.627 Condition of participation: Organizational structure.
42:5.0.1.1.4.4.7.14SECTION 485.631
     485.631 Condition of participation: Staffing and staff responsibilities.
42:5.0.1.1.4.4.7.15SECTION 485.635
     485.635 Condition of participation: Provision of services.
42:5.0.1.1.4.4.7.16SECTION 485.638
     485.638 Conditions of participation: Clinical records.
42:5.0.1.1.4.4.7.17SECTION 485.639
     485.639 Condition of participation: Surgical services.
42:5.0.1.1.4.4.7.18SECTION 485.640
     485.640 Condition of participation: Infection prevention and control and antibiotic stewardship programs.
42:5.0.1.1.4.4.7.19SECTION 485.641
     485.641 Condition of participation: Quality assessment and performance improvement program.
42:5.0.1.1.4.4.7.20SECTION 485.642
     485.642 Condition of participation: Discharge planning.
42:5.0.1.1.4.4.7.21SECTION 485.643
     485.643 Condition of participation: Organ, tissue, and eye procurement.
42:5.0.1.1.4.4.7.22SECTION 485.645
     485.645 Special requirements for CAH providers of long-term care services (“swing-beds”)
42:5.0.1.1.4.4.7.23SECTION 485.647
     485.647 Condition of participation: psychiatric and rehabilitation distinct part units.
42:5.0.1.1.4.5SUBPART G
Subpart G [Reserved]
42:5.0.1.1.4.6SUBPART H
Subpart H - Conditions of Participation for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
42:5.0.1.1.4.6.7.1SECTION 485.701
     485.701 Basis and scope.
42:5.0.1.1.4.6.7.2SECTION 485.703
     485.703 Definitions.
42:5.0.1.1.4.6.7.3SECTION 485.705
     485.705 Personnel qualifications.
42:5.0.1.1.4.6.7.4SECTION 485.707
     485.707 Condition of participation: Compliance with Federal, State, and local laws.
42:5.0.1.1.4.6.7.5SECTION 485.709
     485.709 Condition of participation: Administrative management.
42:5.0.1.1.4.6.7.6SECTION 485.711
     485.711 Condition of participation: Plan of care and physician involvement.
42:5.0.1.1.4.6.7.7SECTION 485.713
     485.713 Condition of participation: Physical therapy services.
42:5.0.1.1.4.6.7.8SECTION 485.715
     485.715 Condition of participation: Speech pathology services.
42:5.0.1.1.4.6.7.9SECTION 485.717
     485.717 Condition of participation: Rehabilitation program.
42:5.0.1.1.4.6.7.10SECTION 485.719
     485.719 Condition of participation: Arrangements for physical therapy and speech pathology services to be performed by other than salaried organization personnel.
42:5.0.1.1.4.6.7.11SECTION 485.721
     485.721 Condition of participation: Clinical records.
42:5.0.1.1.4.6.7.12SECTION 485.723
     485.723 Condition of participation: Physical environment.
42:5.0.1.1.4.6.7.13SECTION 485.725
     485.725 Condition of participation: Infection control.
42:5.0.1.1.4.6.7.14SECTION 485.727
     485.727 Condition of participation: Emergency preparedness.
42:5.0.1.1.4.6.7.15SECTION 485.729
     485.729 Condition of participation: Program evaluation.
42:5.0.1.1.4.7SUBPART I
Subpart I [Reserved]
42:5.0.1.1.4.8SUBPART J
Subpart J - Conditions of Participation: Community Mental Health Centers (CMHCs)
42:5.0.1.1.4.8.7.1SECTION 485.900
     485.900 Basis and scope.
42:5.0.1.1.4.8.7.2SECTION 485.902
     485.902 Definitions.
42:5.0.1.1.4.8.7.3SECTION 485.904
     485.904 Condition of participation: Personnel qualifications.
42:5.0.1.1.4.8.7.4SECTION 485.910
     485.910 Condition of participation: Client rights.
42:5.0.1.1.4.8.7.5SECTION 485.914
     485.914 Condition of participation: Admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client.
42:5.0.1.1.4.8.7.6SECTION 485.916
     485.916 Condition of participation: Treatment team, person-centered active treatment plan, and coordination of services.
42:5.0.1.1.4.8.7.7SECTION 485.917
     485.917 Condition of participation: Quality assessment and performance improvement.
42:5.0.1.1.4.8.7.8SECTION 485.918
     485.918 Condition of participation: Organization, governance, administration of services, and partial hospitalization services.
42:5.0.1.1.4.8.7.9SECTION 485.920
     485.920 Condition of participation: Emergency preparedness.
42:5.0.1.1.5PART 486
PART 486 - CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS
42:5.0.1.1.5.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.5.1.13.1SECTION 486.1
     486.1 Basis and scope.
42:5.0.1.1.5.2SUBPART B
Subpart B [Reserved]
42:5.0.1.1.5.3SUBPART C
Subpart C - Conditions for Coverage: Portable X-Ray Services
42:5.0.1.1.5.3.13.1SECTION 486.100
     486.100 Condition for coverage: Compliance with Federal, State, and local laws and regulations.
42:5.0.1.1.5.3.13.2SECTION 486.102
     486.102 Condition for coverage: Supervision by a qualified physician.
42:5.0.1.1.5.3.13.3SECTION 486.104
     486.104 Condition for coverage: Qualifications, orientation and health of technical personnel.
42:5.0.1.1.5.3.13.4SECTION 486.106
     486.106 Condition for coverage: Referral for service and preservation of records.
42:5.0.1.1.5.3.13.5SECTION 486.108
     486.108 Condition for coverage: Safety standards.
42:5.0.1.1.5.3.13.6SECTION 486.110
     486.110 Condition for coverage: Inspection of equipment.
42:5.0.1.1.5.4SUBPART D
Subparts D-F [Reserved]
42:5.0.1.1.5.5SUBPART G
Subpart G - Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations
42:5.0.1.1.5.5.13SUBJGRP 13
  Requirements for Certification and Designation
42:5.0.1.1.5.5.13.1SECTION 486.301
     486.301 Basis and scope.
42:5.0.1.1.5.5.13.2SECTION 486.302
     486.302 Definitions.
42:5.0.1.1.5.5.13.3SECTION 486.303
     486.303 Requirements for certification.
42:5.0.1.1.5.5.13.4SECTION 486.304
     486.304 Requirements for designation.
42:5.0.1.1.5.5.13.5SECTION 486.306
     486.306 OPO service area size designation and documentation requirements.
42:5.0.1.1.5.5.13.6SECTION 486.308
     486.308 Designation of one OPO for each service area.
42:5.0.1.1.5.5.13.7SECTION 486.309
     486.309 Re-certification from August 1, 2006 through July 31, 2010.
42:5.0.1.1.5.5.13.8SECTION 486.310
     486.310 Changes in control or ownership or service area.
42:5.0.1.1.5.5.14SUBJGRP 14
  Re-Certification and De-Certification
42:5.0.1.1.5.5.14.9SECTION 486.312
     486.312 De-certification.
42:5.0.1.1.5.5.14.10SECTION 486.314
     486.314 Appeals.
42:5.0.1.1.5.5.14.11SECTION 486.316
     486.316 Re-certification and competition processes.
42:5.0.1.1.5.5.15SUBJGRP 15
  Organ Procurement Organization Outcome Requirements
42:5.0.1.1.5.5.15.12SECTION 486.318
     486.318 Condition: Outcome measures.
42:5.0.1.1.5.5.16SUBJGRP 16
  Organ Procurement Organization Process Performance Measures
42:5.0.1.1.5.5.16.13SECTION 486.320
     486.320 Condition: Participation in Organ Procurement and Transplantation Network.
42:5.0.1.1.5.5.16.14SECTION 486.322
     486.322 Condition: Relationships with hospitals, critical access hospitals, and tissue banks.
42:5.0.1.1.5.5.16.15SECTION 486.324
     486.324 Condition: Administration and governing body.
42:5.0.1.1.5.5.16.16SECTION 486.326
     486.326 Condition: Human resources.
42:5.0.1.1.5.5.16.17SECTION 486.328
     486.328 Condition: Reporting of data.
42:5.0.1.1.5.5.16.18SECTION 486.330
     486.330 Condition: Information management.
42:5.0.1.1.5.5.16.19SECTION 486.342
     486.342 Condition: Requesting consent.
42:5.0.1.1.5.5.16.20SECTION 486.344
     486.344 Condition: Evaluation and management of potential donors and organ placement and recovery.
42:5.0.1.1.5.5.16.21SECTION 486.346
     486.346 Condition: Organ preparation and transport.
42:5.0.1.1.5.5.16.22SECTION 486.348
     486.348 Condition: Quality assessment and performance improvement (QAPI).
42:5.0.1.1.5.5.16.23SECTION 486.360
     486.360 Condition for Coverage: Emergency preparedness.
42:5.0.1.1.5.6SUBPART H
Subpart H - [Reserved]
42:5.0.1.1.5.7SUBPART I
Subpart I - Requirements for Home Infusion Therapy Suppliers
42:5.0.1.1.5.7.17SUBJGRP 17
  General Provisions
42:5.0.1.1.5.7.17.1SECTION 486.500
     486.500 Basis and scope.
42:5.0.1.1.5.7.17.2SECTION 486.505
     486.505 Definitions.
42:5.0.1.1.5.7.18SUBJGRP 18
  Standards for Home Infusion Therapy
42:5.0.1.1.5.7.18.3SECTION 486.520
     486.520 Plan of care.
42:5.0.1.1.5.7.18.4SECTION 486.525
     486.525 Required services.
42:5.0.1.1.6PART 488
PART 488 - SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
42:5.0.1.1.6.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.6.1.21.1SECTION 488.1
     488.1 Definitions.
42:5.0.1.1.6.1.21.2SECTION 488.2
     488.2 Statutory basis.
42:5.0.1.1.6.1.21.3SECTION 488.3
     488.3 Conditions of participation, conditions for coverage, conditions for certification and long term care requirements.
42:5.0.1.1.6.1.21.4SECTION 488.4
     488.4 General rules for a CMS-approved accreditation program for providers and suppliers.
42:5.0.1.1.6.1.21.5SECTION 488.5
     488.5 Application and re-application procedures for national accrediting organizations.
42:5.0.1.1.6.1.21.6SECTION 488.6
     488.6 Providers or suppliers that participate in the Medicaid program under a CMS-approved accreditation program.
42:5.0.1.1.6.1.21.7SECTION 488.7
     488.7 Release and use of accreditation surveys.
42:5.0.1.1.6.1.21.8SECTION 488.8
     488.8 Ongoing review of accrediting organizations.
42:5.0.1.1.6.1.21.9SECTION 488.9
     488.9 Validation surveys.
42:5.0.1.1.6.1.21.10SECTION 488.10
     488.10 State survey agency review: Statutory provisions.
42:5.0.1.1.6.1.21.11SECTION 488.11
     488.11 State survey agency functions.
42:5.0.1.1.6.1.21.12SECTION 488.12
     488.12 Effect of survey agency certification.
42:5.0.1.1.6.1.21.13SECTION 488.13
     488.13 Loss of accreditation.
42:5.0.1.1.6.1.21.14SECTION 488.14
     488.14 Effect of QIO review.
42:5.0.1.1.6.1.21.15SECTION 488.18
     488.18 Documentation of findings.
42:5.0.1.1.6.1.21.16SECTION 488.20
     488.20 Periodic review of compliance and approval.
42:5.0.1.1.6.1.21.17SECTION 488.24
     488.24 Certification of noncompliance.
42:5.0.1.1.6.1.21.18SECTION 488.26
     488.26 Determining compliance.
42:5.0.1.1.6.1.21.19SECTION 488.28
     488.28 Providers or suppliers, other than SNFs, NFs, and HHAs with deficiencies.
42:5.0.1.1.6.1.21.20SECTION 488.30
     488.30 Revisit user fee for revisit surveys.
42:5.0.1.1.6.2SUBPART B
Subpart B - Special Requirements
42:5.0.1.1.6.2.21.1SECTION 488.52
     488.52 [Reserved]
42:5.0.1.1.6.2.21.2SECTION 488.54
     488.54 Temporary waivers applicable to hospitals.
42:5.0.1.1.6.2.21.3SECTION 488.56
     488.56 Temporary waivers applicable to skilled nursing facilities.
42:5.0.1.1.6.2.21.4SECTION 488.60
     488.60 Special procedures for approving end stage renal disease facilities.
42:5.0.1.1.6.2.21.5SECTION 488.61
     488.61 Special procedures for approval and re-approval of organ transplant programs.
42:5.0.1.1.6.2.21.6SECTION 488.64
     488.64 Remote facility variances for utilization review requirements.
42:5.0.1.1.6.2.21.7SECTION 488.68
     488.68 State Agency responsibilities for OASIS collection and data base requirements.
42:5.0.1.1.6.3SUBPART C
Subpart C - Survey Forms and Procedures
42:5.0.1.1.6.3.21.1SECTION 488.100
     488.100 Long term care survey forms, Part A.
42:5.0.1.1.6.3.21.2SECTION 488.105
     488.105 Long term care survey forms, Part B.
42:5.0.1.1.6.3.21.3SECTION 488.110
     488.110 Procedural guidelines.
42:5.0.1.1.6.3.21.4SECTION 488.115
     488.115 Care guidelines.
42:5.0.1.1.6.4SUBPART D
Subpart D - Reconsideration of Adverse Determinations - Deeming Authority for Accreditation Organizations and CLIA Exemption of Laboratories Under State Programs
42:5.0.1.1.6.4.21.1SECTION 488.201
     488.201 Reconsideration.
42:5.0.1.1.6.4.21.2SECTION 488.203
     488.203 Withdrawal of request for reconsideration.
42:5.0.1.1.6.4.21.3SECTION 488.205
     488.205 Right to informal hearing.
42:5.0.1.1.6.4.21.4SECTION 488.207
     488.207 Informal hearing procedures.
42:5.0.1.1.6.4.21.5SECTION 488.209
     488.209 Hearing officer's findings.
42:5.0.1.1.6.4.21.6SECTION 488.211
     488.211 Final reconsideration determination.
42:5.0.1.1.6.5SUBPART E
Subpart E - Survey and Certification of Long-Term Care Facilities
42:5.0.1.1.6.5.21.1SECTION 488.300
     488.300 Statutory basis.
42:5.0.1.1.6.5.21.2SECTION 488.301
     488.301 Definitions.
42:5.0.1.1.6.5.21.3SECTION 488.303
     488.303 State plan requirement.
42:5.0.1.1.6.5.21.4SECTION 488.305
     488.305 Standard surveys.
42:5.0.1.1.6.5.21.5SECTION 488.307
     488.307 Unannounced surveys.
42:5.0.1.1.6.5.21.6SECTION 488.308
     488.308 Survey frequency.
42:5.0.1.1.6.5.21.7SECTION 488.310
     488.310 Extended survey.
42:5.0.1.1.6.5.21.8SECTION 488.312
     488.312 Consistency of survey results.
42:5.0.1.1.6.5.21.9SECTION 488.314
     488.314 Survey teams.
42:5.0.1.1.6.5.21.10SECTION 488.318
     488.318 Inadequate survey performance.
42:5.0.1.1.6.5.21.11SECTION 488.320
     488.320 Sanctions for inadequate survey performance.
42:5.0.1.1.6.5.21.12SECTION 488.325
     488.325 Disclosure of results of surveys and activities.
42:5.0.1.1.6.5.21.13SECTION 488.330
     488.330 Certification of compliance or noncompliance.
42:5.0.1.1.6.5.21.14SECTION 488.331
     488.331 Informal dispute resolution.
42:5.0.1.1.6.5.21.15SECTION 488.332
     488.332 Investigation of complaints of violations and monitoring of compliance.
42:5.0.1.1.6.5.21.16SECTION 488.334
     488.334 Educational programs.
42:5.0.1.1.6.5.21.17SECTION 488.335
     488.335 Action on complaints of resident neglect and abuse, and misappropriation of resident property.
42:5.0.1.1.6.6SUBPART F
Subpart F - Enforcement of Compliance for Long-Term Care Facilities with Deficiencies
42:5.0.1.1.6.6.21.1SECTION 488.400
     488.400 Statutory basis.
42:5.0.1.1.6.6.21.2SECTION 488.401
     488.401 Definitions.
42:5.0.1.1.6.6.21.3SECTION 488.402
     488.402 General provisions.
42:5.0.1.1.6.6.21.4SECTION 488.404
     488.404 Factors to be considered in selecting remedies.
42:5.0.1.1.6.6.21.5SECTION 488.406
     488.406 Available remedies.
42:5.0.1.1.6.6.21.6SECTION 488.408
     488.408 Selection of remedies.
42:5.0.1.1.6.6.21.7SECTION 488.410
     488.410 Action when there is immediate jeopardy.
42:5.0.1.1.6.6.21.8SECTION 488.412
     488.412 Action when there is no immediate jeopardy.
42:5.0.1.1.6.6.21.9SECTION 488.414
     488.414 Action when there is repeated substandard quality of care.
42:5.0.1.1.6.6.21.10SECTION 488.415
     488.415 Temporary management.
42:5.0.1.1.6.6.21.11SECTION 488.417
     488.417 Denial of payment for all new admissions.
42:5.0.1.1.6.6.21.12SECTION 488.418
     488.418 Secretarial authority to deny all payments.
42:5.0.1.1.6.6.21.13SECTION 488.422
     488.422 State monitoring.
42:5.0.1.1.6.6.21.14SECTION 488.424
     488.424 Directed plan of correction.
42:5.0.1.1.6.6.21.15SECTION 488.425
     488.425 Directed inservice training.
42:5.0.1.1.6.6.21.16SECTION 488.426
     488.426 Transfer of residents, or closure of the facility and transfer of residents.
42:5.0.1.1.6.6.21.17SECTION 488.430
     488.430 Civil money penalties: Basis for imposing penalty.
42:5.0.1.1.6.6.21.18SECTION 488.431
     488.431 Civil money penalties imposed by CMS and independent informal dispute resolution: for SNFS, dually-participating SNF/NFs, and NF-only facilities.
42:5.0.1.1.6.6.21.19SECTION 488.432
     488.432 Civil money penalties imposed by the State: NF-only.
42:5.0.1.1.6.6.21.20SECTION 488.433
     488.433 Civil money penalties: Uses and approval of civil money penalties imposed by CMS.
42:5.0.1.1.6.6.21.21SECTION 488.434
     488.434 Civil money penalties: Notice of penalty.
42:5.0.1.1.6.6.21.22SECTION 488.436
     488.436 Civil money penalties: Waiver of hearing, reduction of penalty amount.
42:5.0.1.1.6.6.21.23SECTION 488.438
     488.438 Civil money penalties: Amount of penalty.
42:5.0.1.1.6.6.21.24SECTION 488.440
     488.440 Civil money penalties: Effective date and duration of penalty.
42:5.0.1.1.6.6.21.25SECTION 488.442
     488.442 Civil money penalties: Due date for payment of penalty.
42:5.0.1.1.6.6.21.26SECTION 488.444
     488.444 Civil money penalties: Settlement of penalties.
42:5.0.1.1.6.6.21.27SECTION 488.446
     488.446 Administrator sanctions: long-term care facility closures.
42:5.0.1.1.6.6.21.28SECTION 488.447
     488.447 Civil Money Penalties imposed for failure to comply with 42 CFR 483.80(g)(1) and (2).
42:5.0.1.1.6.6.21.29SECTION 488.450
     488.450 Continuation of payments to a facility with deficiencies.
42:5.0.1.1.6.6.21.30SECTION 488.452
     488.452 State and Federal disagreements involving findings not in agreement in non-State operated NFs and dually participating facilities when there is no immediate jeopardy.
42:5.0.1.1.6.6.21.31SECTION 488.454
     488.454 Duration of remedies.
42:5.0.1.1.6.6.21.32SECTION 488.456
     488.456 Termination of provider agreement.
42:5.0.1.1.6.7SUBPART G
Subpart G [Reserved]
42:5.0.1.1.6.8SUBPART H
Subpart H - Termination of Medicare Coverage and Alternative Sanctions for End-Stage Renal Disease (ESRD) Facilities
42:5.0.1.1.6.8.21.1SECTION 488.604
     488.604 Termination of Medicare coverage.
42:5.0.1.1.6.8.21.2SECTION 488.606
     488.606 Alternative sanctions.
42:5.0.1.1.6.8.21.3SECTION 488.608
     488.608 Notice of alternative sanction and appeal rights: Termination of coverage.
42:5.0.1.1.6.8.21.4SECTION 488.610
     488.610 Notice of appeal rights: Alternative sanctions.
42:5.0.1.1.6.9SUBPART I
Subpart I - Survey and Certification of Home Health Agencies
42:5.0.1.1.6.9.21.1SECTION 488.700
     488.700 Basis and scope.
42:5.0.1.1.6.9.21.2SECTION 488.705
     488.705 Definitions.
42:5.0.1.1.6.9.21.3SECTION 488.710
     488.710 Standard surveys.
42:5.0.1.1.6.9.21.4SECTION 488.715
     488.715 Partial extended surveys.
42:5.0.1.1.6.9.21.5SECTION 488.720
     488.720 Extended surveys.
42:5.0.1.1.6.9.21.6SECTION 488.725
     488.725 Unannounced surveys.
42:5.0.1.1.6.9.21.7SECTION 488.730
     488.730 Survey frequency and content.
42:5.0.1.1.6.9.21.8SECTION 488.735
     488.735 Surveyor qualifications.
42:5.0.1.1.6.9.21.9SECTION 488.740
     488.740 Certification of compliance or noncompliance.
42:5.0.1.1.6.9.21.10SECTION 488.745
     488.745 Informal Dispute Resolution (IDR).
42:5.0.1.1.6.10SUBPART J
Subpart J - Alternative Sanctions for Home Health Agencies With Deficiencies
42:5.0.1.1.6.10.21.1SECTION 488.800
     488.800 Statutory basis.
42:5.0.1.1.6.10.21.2SECTION 488.805
     488.805 Definitions.
42:5.0.1.1.6.10.21.3SECTION 488.810
     488.810 General provisions.
42:5.0.1.1.6.10.21.4SECTION 488.815
     488.815 Factors to be considered in selecting sanctions.
42:5.0.1.1.6.10.21.5SECTION 488.820
     488.820 Available sanctions.
42:5.0.1.1.6.10.21.6SECTION 488.825
     488.825 Action when deficiencies pose immediate jeopardy.
42:5.0.1.1.6.10.21.7SECTION 488.830
     488.830 Action when deficiencies are at the condition-level but do not pose immediate jeopardy.
42:5.0.1.1.6.10.21.8SECTION 488.835
     488.835 Temporary management.
42:5.0.1.1.6.10.21.9SECTION 488.840
     488.840 Suspension of payment for all new patient admissions.
42:5.0.1.1.6.10.21.10SECTION 488.845
     488.845 Civil money penalties.
42:5.0.1.1.6.10.21.11SECTION 488.850
     488.850 Directed plan of correction.
42:5.0.1.1.6.10.21.12SECTION 488.855
     488.855 Directed in-service training.
42:5.0.1.1.6.10.21.13SECTION 488.860
     488.860 Continuation of payments to an HHA with deficiencies.
42:5.0.1.1.6.10.21.14SECTION 488.865
     488.865 Termination of provider agreement.
42:5.0.1.1.6.11SUBPART K
Subpart K - [Reserved]
42:5.0.1.1.6.12SUBPART L
Subpart L - Accreditation of Home Infusion Therapy Suppliers
42:5.0.1.1.6.12.21SUBJGRP 21
  General Provisions
42:5.0.1.1.6.12.21.1SECTION 488.1000
     488.1000 Basis and scope.
42:5.0.1.1.6.12.21.2SECTION 488.1005
     488.1005 Definitions.
42:5.0.1.1.6.12.22SUBJGRP 22
  Approval and Oversight of Home Infusion Therapy Supplier Accrediting Organizations
42:5.0.1.1.6.12.22.3SECTION 488.1010
     488.1010 Application and reapplication procedures for national home infusion therapy accrediting organizations.
42:5.0.1.1.6.12.22.4SECTION 488.1015
     488.1015 Resubmitting a request for reapproval.
42:5.0.1.1.6.12.22.5SECTION 488.1020
     488.1020 Public notice and comment.
42:5.0.1.1.6.12.22.6SECTION 488.1025
     488.1025 Release and use of home infusion therapy accreditation surveys.
42:5.0.1.1.6.12.22.7SECTION 488.1030
     488.1030 Ongoing review of home infusion therapy accrediting organizations.
42:5.0.1.1.6.12.22.8SECTION 488.1035
     488.1035 Ongoing responsibilities of a CMS-approved home infusion therapy accrediting organization.
42:5.0.1.1.6.12.22.9SECTION 488.1040
     488.1040 Onsite observations of home infusion therapy accrediting organization operations.
42:5.0.1.1.6.12.22.10SECTION 488.1045
     488.1045 Voluntary and involuntary termination.
42:5.0.1.1.6.12.22.11SECTION 488.1050
     488.1050 Reconsideration.
42:5.0.1.1.7PART 489
PART 489 - PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
42:5.0.1.1.7.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.7.1.23.1SECTION 489.1
     489.1 Statutory basis.
42:5.0.1.1.7.1.23.2SECTION 489.2
     489.2 Scope of part.
42:5.0.1.1.7.1.23.3SECTION 489.3
     489.3 Definitions.
42:5.0.1.1.7.1.23.4SECTION 489.10
     489.10 Basic requirements.
42:5.0.1.1.7.1.23.5SECTION 489.11
     489.11 Acceptance of a provider as a participant.
42:5.0.1.1.7.1.23.6SECTION 489.12
     489.12 Decision to deny an agreement.
42:5.0.1.1.7.1.23.7SECTION 489.13
     489.13 Effective date of agreement or approval.
42:5.0.1.1.7.1.23.8SECTION 489.18
     489.18 Change of ownership or leasing: Effect on provider agreement.
42:5.0.1.1.7.2SUBPART B
Subpart B - Essentials of Provider Agreements
42:5.0.1.1.7.2.23.1SECTION 489.20
     489.20 Basic commitments.
42:5.0.1.1.7.2.23.2SECTION 489.21
     489.21 Specific limitations on charges.
42:5.0.1.1.7.2.23.3SECTION 489.22
     489.22 Special provisions applicable to prepayment requirements.
42:5.0.1.1.7.2.23.4SECTION 489.23
     489.23 Specific limitation on charges for services provided to certain enrollees of fee-for-service FEHB plans.
42:5.0.1.1.7.2.23.5SECTION 489.24
     489.24 Special responsibilities of Medicare hospitals in emergency cases.
42:5.0.1.1.7.2.23.6SECTION 489.25
     489.25 Special requirements concerning CHAMPUS and CHAMPVA programs.
42:5.0.1.1.7.2.23.7SECTION 489.26
     489.26 Special requirements concerning veterans.
42:5.0.1.1.7.2.23.8SECTION 489.27
     489.27 Beneficiary notice of discharge rights.
42:5.0.1.1.7.2.23.9SECTION 489.28
     489.28 Special capitalization requirements for HHAs.
42:5.0.1.1.7.2.23.10SECTION 489.29
     489.29 Special requirements concerning beneficiaries served by the Indian Health Service, Tribal health programs, and urban Indian organization health programs.
42:5.0.1.1.7.3SUBPART C
Subpart C - Allowable Charges
42:5.0.1.1.7.3.23.1SECTION 489.30
     489.30 Allowable charges: Deductibles and coinsurance.
42:5.0.1.1.7.3.23.2SECTION 489.31
     489.31 Allowable charges: Blood.
42:5.0.1.1.7.3.23.3SECTION 489.32
     489.32 Allowable charges: Noncovered and partially covered services.
42:5.0.1.1.7.3.23.4SECTION 489.34
     489.34 Allowable charges: Hospitals participating in State reimbursement control systems or demonstration projects.
42:5.0.1.1.7.3.23.5SECTION 489.35
     489.35 Notice to intermediary.
42:5.0.1.1.7.4SUBPART D
Subpart D - Handling of Incorrect Collections
42:5.0.1.1.7.4.23.1SECTION 489.40
     489.40 Definition of incorrect collection.
42:5.0.1.1.7.4.23.2SECTION 489.41
     489.41 Timing and methods of handling.
42:5.0.1.1.7.4.23.3SECTION 489.42
     489.42 Payment of offset amounts to beneficiary or other person.
42:5.0.1.1.7.5SUBPART E
Subpart E - Termination of Agreement and Reinstatement After Termination
42:5.0.1.1.7.5.23.1SECTION 489.52
     489.52 Termination by the provider.
42:5.0.1.1.7.5.23.2SECTION 489.53
     489.53 Termination by CMS.
42:5.0.1.1.7.5.23.3SECTION 489.54
     489.54 Termination by the OIG.
42:5.0.1.1.7.5.23.4SECTION 489.55
     489.55 Exceptions to effective date of termination.
42:5.0.1.1.7.5.23.5SECTION 489.57
     489.57 Reinstatement after termination.
42:5.0.1.1.7.6SUBPART F
Subpart F - Surety Bond Requirements for HHAs
42:5.0.1.1.7.6.23.1SECTION 489.60
     489.60 Definitions.
42:5.0.1.1.7.6.23.2SECTION 489.61
     489.61 Basic requirement for surety bonds.
42:5.0.1.1.7.6.23.3SECTION 489.62
     489.62 Requirement waived for Government-operated HHAs.
42:5.0.1.1.7.6.23.4SECTION 489.63
     489.63 Parties to the bond.
42:5.0.1.1.7.6.23.5SECTION 489.64
     489.64 Authorized Surety and exclusion of surety companies.
42:5.0.1.1.7.6.23.6SECTION 489.65
     489.65 Amount of the bond.
42:5.0.1.1.7.6.23.7SECTION 489.66
     489.66 Additional requirements of the surety bond.
42:5.0.1.1.7.6.23.8SECTION 489.67
     489.67 Term and type of bond.
42:5.0.1.1.7.6.23.9SECTION 489.68
     489.68 Effect of failure to obtain, maintain, and timely file a surety bond.
42:5.0.1.1.7.6.23.10SECTION 489.69
     489.69 Evidence of compliance.
42:5.0.1.1.7.6.23.11SECTION 489.70
     489.70 Effect of payment by the Surety.
42:5.0.1.1.7.6.23.12SECTION 489.71
     489.71 Surety's standing to appeal Medicare determinations.
42:5.0.1.1.7.6.23.13SECTION 489.72
     489.72 Effect of review reversing determination.
42:5.0.1.1.7.6.23.14SECTION 489.73
     489.73 Effect of conditions of payment.
42:5.0.1.1.7.6.23.15SECTION 489.74
     489.74 Incorporation into existing provider agreements.
42:5.0.1.1.7.7SUBPART G
Subparts G-H [Reserved]
42:5.0.1.1.7.8SUBPART I
Subpart I - Advance Directives
42:5.0.1.1.7.8.23.1SECTION 489.100
     489.100 Definition.
42:5.0.1.1.7.8.23.2SECTION 489.102
     489.102 Requirements for providers.
42:5.0.1.1.7.8.23.3SECTION 489.104
     489.104 Effective dates.
42:5.0.1.1.8PART 491
PART 491 - CERTIFICATION OF CERTAIN HEALTH FACILITIES
42:5.0.1.1.8.1SUBPART A
Subpart A - Rural Health Clinics: Conditions for Certification; and FQHCs Conditions for Coverage
42:5.0.1.1.8.1.23.1SECTION 491.1
     491.1 Purpose and scope.
42:5.0.1.1.8.1.23.2SECTION 491.2
     491.2 Definitions.
42:5.0.1.1.8.1.23.3SECTION 491.3
     491.3 Certification procedures.
42:5.0.1.1.8.1.23.4SECTION 491.4
     491.4 Compliance with Federal, State and local laws.
42:5.0.1.1.8.1.23.5SECTION 491.5
     491.5 Location of clinic.
42:5.0.1.1.8.1.23.6SECTION 491.6
     491.6 Physical plant and environment.
42:5.0.1.1.8.1.23.7SECTION 491.7
     491.7 Organizational structure.
42:5.0.1.1.8.1.23.8SECTION 491.8
     491.8 Staffing and staff responsibilities.
42:5.0.1.1.8.1.23.9SECTION 491.9
     491.9 Provision of services.
42:5.0.1.1.8.1.23.10SECTION 491.10
     491.10 Patient health records.
42:5.0.1.1.8.1.23.11SECTION 491.11
     491.11 Program evaluation.
42:5.0.1.1.8.1.23.12SECTION 491.12
     491.12 Emergency preparedness.
42:5.0.1.1.9PART 493
PART 493 - LABORATORY REQUIREMENTS
42:5.0.1.1.9.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.9.1.32.1SECTION 493.1
     493.1 Basis and scope.
42:5.0.1.1.9.1.32.2SECTION 493.2
     493.2 Definitions.
42:5.0.1.1.9.1.32.3SECTION 493.3
     493.3 Applicability.
42:5.0.1.1.9.1.32.4SECTION 493.5
     493.5 Categories of tests by complexity.
42:5.0.1.1.9.1.32.5SECTION 493.15
     493.15 Laboratories performing waived tests.
42:5.0.1.1.9.1.32.6SECTION 493.17
     493.17 Test categorization.
42:5.0.1.1.9.1.32.7SECTION 493.19
     493.19 Provider-performed microscopy (PPM) procedures.
42:5.0.1.1.9.1.32.8SECTION 493.20
     493.20 Laboratories performing tests of moderate complexity.
42:5.0.1.1.9.1.32.9SECTION 493.25
     493.25 Laboratories performing tests of high complexity.
42:5.0.1.1.9.2SUBPART B
Subpart B - Certificate of Waiver
42:5.0.1.1.9.2.32.1SECTION 493.35
     493.35 Application for a certificate of waiver.
42:5.0.1.1.9.2.32.2SECTION 493.37
     493.37 Requirements for a certificate of waiver.
42:5.0.1.1.9.2.32.3SECTION 493.39
     493.39 Notification requirements for laboratories issued a certificate of waiver.
42:5.0.1.1.9.2.32.4SECTION 493.41
     493.41 Condition: Reporting of SARS-CoV-2 test results.
42:5.0.1.1.9.3SUBPART C
Subpart C - Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance
42:5.0.1.1.9.3.32.1SECTION 493.43
     493.43 Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance.
42:5.0.1.1.9.3.32.2SECTION 493.45
     493.45 Requirements for a registration certificate.
42:5.0.1.1.9.3.32.3SECTION 493.47
     493.47 Requirements for a certificate for provider-performed microscopy (PPM) procedures.
42:5.0.1.1.9.3.32.4SECTION 493.49
     493.49 Requirements for a certificate of compliance.
42:5.0.1.1.9.3.32.5SECTION 493.51
     493.51 Notification requirements for laboratories issued a certificate of compliance.
42:5.0.1.1.9.3.32.6SECTION 493.53
     493.53 Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures.
42:5.0.1.1.9.4SUBPART D
Subpart D - Certificate of Accreditation
42:5.0.1.1.9.4.32.1SECTION 493.55
     493.55 Application for registration certificate and certificate of accreditation.
42:5.0.1.1.9.4.32.2SECTION 493.57
     493.57 Requirements for a registration certificate.
42:5.0.1.1.9.4.32.3SECTION 493.61
     493.61 Requirements for a certificate of accreditation.
42:5.0.1.1.9.4.32.4SECTION 493.63
     493.63 Notification requirements for laboratories issued a certificate of accreditation.
42:5.0.1.1.9.5SUBPART E
Subpart E - Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program
42:5.0.1.1.9.5.32.1SECTION 493.551
     493.551 General requirements for laboratories.
42:5.0.1.1.9.5.32.2SECTION 493.553
     493.553 Approval process (application and reapplication) for accreditation organizations and State licensure programs.
42:5.0.1.1.9.5.32.3SECTION 493.555
     493.555 Federal review of laboratory requirements.
42:5.0.1.1.9.5.32.4SECTION 493.557
     493.557 Additional submission requirements.
42:5.0.1.1.9.5.32.5SECTION 493.559
     493.559 Publication of approval of deeming authority or CLIA exemption.
42:5.0.1.1.9.5.32.6SECTION 493.561
     493.561 Denial of application or reapplication.
42:5.0.1.1.9.5.32.7SECTION 493.563
     493.563 Validation inspections - Basis and focus.
42:5.0.1.1.9.5.32.8SECTION 493.565
     493.565 Selection for validation inspection - laboratory responsibilities.
42:5.0.1.1.9.5.32.9SECTION 493.567
     493.567 Refusal to cooperate with validation inspection.
42:5.0.1.1.9.5.32.10SECTION 493.569
     493.569 Consequences of a finding of noncompliance as a result of a validation inspection.
42:5.0.1.1.9.5.32.11SECTION 493.571
     493.571 Disclosure of accreditation, State and CMS validation inspection results.
42:5.0.1.1.9.5.32.12SECTION 493.573
     493.573 Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs.
42:5.0.1.1.9.5.32.13SECTION 493.575
     493.575 Removal of deeming authority or CLIA exemption and final determination review.
42:5.0.1.1.9.6SUBPART F
Subpart F - General Administration
42:5.0.1.1.9.6.32.1SECTION 493.602
     493.602 Scope of subpart.
42:5.0.1.1.9.6.32.2SECTION 493.606
     493.606 Applicability of subpart.
42:5.0.1.1.9.6.32.3SECTION 493.638
     493.638 Certificate fees.
42:5.0.1.1.9.6.32.4SECTION 493.639
     493.639 Fee for revised certificate.
42:5.0.1.1.9.6.32.5SECTION 493.643
     493.643 Fee for determination of program compliance.
42:5.0.1.1.9.6.32.6SECTION 493.645
     493.645 Additional fee(s) applicable to approved State laboratory programs and laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.
42:5.0.1.1.9.6.32.7SECTION 493.646
     493.646 Payment of fees.
42:5.0.1.1.9.6.32.8SECTION 493.649
     493.649 Methodology for determining fee amount.
42:5.0.1.1.9.7SUBPART G
Subpart G [Reserved]
42:5.0.1.1.9.8SUBPART H
Subpart H - Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing
42:5.0.1.1.9.8.32SUBJGRP 32
  Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate Complexity (Including the Subcategory), High Complexity, or Any Combination of These Tests
42:5.0.1.1.9.8.32.1SECTION 493.801
     493.801 Condition: Enrollment and testing of samples.
42:5.0.1.1.9.8.32.2SECTION 493.803
     493.803 Condition: Successful participation.
42:5.0.1.1.9.8.32.3SECTION 493.807
     493.807 Condition: Reinstatement of laboratories performing nonwaived testing.
42:5.0.1.1.9.8.32.4SECTION 493.821
     493.821 Condition: Microbiology.
42:5.0.1.1.9.8.32.5SECTION 493.823
     493.823 Standard; Bacteriology.
42:5.0.1.1.9.8.32.6SECTION 493.825
     493.825 Standard; Mycobacteriology.
42:5.0.1.1.9.8.32.7SECTION 493.827
     493.827 Standard; Mycology.
42:5.0.1.1.9.8.32.8SECTION 493.829
     493.829 Standard; Parasitology.
42:5.0.1.1.9.8.32.9SECTION 493.831
     493.831 Standard; Virology.
42:5.0.1.1.9.8.32.10SECTION 493.833
     493.833 Condition: Diagnostic immunology.
42:5.0.1.1.9.8.32.11SECTION 493.835
     493.835 Standard; Syphilis serology.
42:5.0.1.1.9.8.32.12SECTION 493.837
     493.837 Standard; General immunology.
42:5.0.1.1.9.8.32.13SECTION 493.839
     493.839 Condition: Chemistry.
42:5.0.1.1.9.8.32.14SECTION 493.841
     493.841 Standard; Routine chemistry.
42:5.0.1.1.9.8.32.15SECTION 493.843
     493.843 Standard; Endocrinology.
42:5.0.1.1.9.8.32.16SECTION 493.845
     493.845 Standard; Toxicology.
42:5.0.1.1.9.8.32.17SECTION 493.849
     493.849 Condition: Hematology.
42:5.0.1.1.9.8.32.18SECTION 493.851
     493.851 Standard; Hematology.
42:5.0.1.1.9.8.32.19SECTION 493.853
     493.853 Condition: Pathology.
42:5.0.1.1.9.8.32.20SECTION 493.855
     493.855 Standard; Cytology: gynecologic examinations.
42:5.0.1.1.9.8.32.21SECTION 493.857
     493.857 Condition: Immunohematology.
42:5.0.1.1.9.8.32.22SECTION 493.859
     493.859 Standard; ABO group and D (Rho) typing.
42:5.0.1.1.9.8.32.23SECTION 493.861
     493.861 Standard; Unexpected antibody detection.
42:5.0.1.1.9.8.32.24SECTION 493.863
     493.863 Standard; Compatibility testing.
42:5.0.1.1.9.8.32.25SECTION 493.865
     493.865 Standard; Antibody identification.
42:5.0.1.1.9.9SUBPART I
Subpart I - Proficiency Testing Programs for Nonwaived Testing
42:5.0.1.1.9.9.33SUBJGRP 33
  Proficiency Testing Programs by Specialty and Subspecialty
42:5.0.1.1.9.9.33.1SECTION 493.901
     493.901 Approval of proficiency testing programs.
42:5.0.1.1.9.9.33.2SECTION 493.903
     493.903 Administrative responsibilities.
42:5.0.1.1.9.9.33.3SECTION 493.905
     493.905 Nonapproved proficiency testing programs.
42:5.0.1.1.9.9.33.4SECTION 493.909
     493.909 Microbiology.
42:5.0.1.1.9.9.33.5SECTION 493.911
     493.911 Bacteriology.
42:5.0.1.1.9.9.33.6SECTION 493.913
     493.913 Mycobacteriology.
42:5.0.1.1.9.9.33.7SECTION 493.915
     493.915 Mycology.
42:5.0.1.1.9.9.33.8SECTION 493.917
     493.917 Parasitology.
42:5.0.1.1.9.9.33.9SECTION 493.919
     493.919 Virology.
42:5.0.1.1.9.9.33.10SECTION 493.921
     493.921 Diagnostic immunology.
42:5.0.1.1.9.9.33.11SECTION 493.923
     493.923 Syphilis serology.
42:5.0.1.1.9.9.33.12SECTION 493.927
     493.927 General immunology.
42:5.0.1.1.9.9.33.13SECTION 493.929
     493.929 Chemistry.
42:5.0.1.1.9.9.33.14SECTION 493.931
     493.931 Routine chemistry.
42:5.0.1.1.9.9.33.15SECTION 493.933
     493.933 Endocrinology.
42:5.0.1.1.9.9.33.16SECTION 493.937
     493.937 Toxicology.
42:5.0.1.1.9.9.33.17SECTION 493.941
     493.941 Hematology (including routine hematology and coagulation).
42:5.0.1.1.9.9.33.18SECTION 493.945
     493.945 Cytology; gynecologic examinations.
42:5.0.1.1.9.9.33.19SECTION 493.959
     493.959 Immunohematology.
42:5.0.1.1.9.10SUBPART J
Subpart J - Facility Administration for Nonwaived Testing
42:5.0.1.1.9.10.34.1SECTION 493.1100
     493.1100 Condition: Facility administration.
42:5.0.1.1.9.10.34.2SECTION 493.1101
     493.1101 Standard: Facilities.
42:5.0.1.1.9.10.34.3SECTION 493.1103
     493.1103 Standard: Requirements for transfusion services.
42:5.0.1.1.9.10.34.4SECTION 493.1105
     493.1105 Standard: Retention requirements.
42:5.0.1.1.9.11SUBPART K
Subpart K - Quality System for Nonwaived Testing
42:5.0.1.1.9.11.34SUBJGRP 34
  General Laboratory Systems
42:5.0.1.1.9.11.34.1SECTION 493.1200
     493.1200 Introduction.
42:5.0.1.1.9.11.34.2SECTION 493.1201
     493.1201 Condition: Bacteriology.
42:5.0.1.1.9.11.34.3SECTION 493.1202
     493.1202 Condition: Mycobacteriology.
42:5.0.1.1.9.11.34.4SECTION 493.1203
     493.1203 Condition: Mycology.
42:5.0.1.1.9.11.34.5SECTION 493.1204
     493.1204 Condition: Parasitology.
42:5.0.1.1.9.11.34.6SECTION 493.1205
     493.1205 Condition: Virology.
42:5.0.1.1.9.11.34.7SECTION 493.1207
     493.1207 Condition: Syphilis serology.
42:5.0.1.1.9.11.34.8SECTION 493.1208
     493.1208 Condition: General immunology.
42:5.0.1.1.9.11.34.9SECTION 493.1210
     493.1210 Condition: Routine chemistry.
42:5.0.1.1.9.11.34.10SECTION 493.1211
     493.1211 Condition: Urinalysis.
42:5.0.1.1.9.11.34.11SECTION 493.1212
     493.1212 Condition: Endocrinology.
42:5.0.1.1.9.11.34.12SECTION 493.1213
     493.1213 Condition: Toxicology.
42:5.0.1.1.9.11.34.13SECTION 493.1215
     493.1215 Condition: Hematology.
42:5.0.1.1.9.11.34.14SECTION 493.1217
     493.1217 Condition: Immunohematology.
42:5.0.1.1.9.11.34.15SECTION 493.1219
     493.1219 Condition: Histopathology.
42:5.0.1.1.9.11.34.16SECTION 493.1220
     493.1220 Condition: Oral pathology.
42:5.0.1.1.9.11.34.17SECTION 493.1221
     493.1221 Condition: Cytology.
42:5.0.1.1.9.11.34.18SECTION 493.1225
     493.1225 Condition: Clinical cytogenetics.
42:5.0.1.1.9.11.34.19SECTION 493.1226
     493.1226 Condition: Radiobioassay.
42:5.0.1.1.9.11.34.20SECTION 493.1227
     493.1227 Condition: Histocompatibility.
42:5.0.1.1.9.11.34.21SECTION 493.1230
     493.1230 Condition: General laboratory systems.
42:5.0.1.1.9.11.34.22SECTION 493.1231
     493.1231 Standard: Confidentiality of patient information.
42:5.0.1.1.9.11.34.23SECTION 493.1232
     493.1232 Standard: Specimen identification and integrity.
42:5.0.1.1.9.11.34.24SECTION 493.1233
     493.1233 Standard: Complaint investigations.
42:5.0.1.1.9.11.34.25SECTION 493.1234
     493.1234 Standard: Communications.
42:5.0.1.1.9.11.34.26SECTION 493.1235
     493.1235 Standard: Personnel competency assessment policies.
42:5.0.1.1.9.11.34.27SECTION 493.1236
     493.1236 Standard: Evaluation of proficiency testing performance.
42:5.0.1.1.9.11.34.28SECTION 493.1239
     493.1239 Standard: General laboratory systems quality assessment.
42:5.0.1.1.9.11.35SUBJGRP 35
  Preanalytic Systems
42:5.0.1.1.9.11.35.29SECTION 493.1240
     493.1240 Condition: Preanalytic systems.
42:5.0.1.1.9.11.35.30SECTION 493.1241
     493.1241 Standard: Test request.
42:5.0.1.1.9.11.35.31SECTION 493.1242
     493.1242 Standard: Specimen submission, handling, and referral.
42:5.0.1.1.9.11.35.32SECTION 493.1249
     493.1249 Standard: Preanalytic systems quality assessment.
42:5.0.1.1.9.11.36SUBJGRP 36
  Analytic Systems
42:5.0.1.1.9.11.36.33SECTION 493.1250
     493.1250 Condition: Analytic systems.
42:5.0.1.1.9.11.36.34SECTION 493.1251
     493.1251 Standard: Procedure manual.
42:5.0.1.1.9.11.36.35SECTION 493.1252
     493.1252 Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
42:5.0.1.1.9.11.36.36SECTION 493.1253
     493.1253 Standard: Establishment and verification of performance specifications.
42:5.0.1.1.9.11.36.37SECTION 493.1254
     493.1254 Standard: Maintenance and function checks.
42:5.0.1.1.9.11.36.38SECTION 493.1255
     493.1255 Standard: Calibration and calibration verification procedures.
42:5.0.1.1.9.11.36.39SECTION 493.1256
     493.1256 Standard: Control procedures.
42:5.0.1.1.9.11.36.40SECTION 493.1261
     493.1261 Standard: Bacteriology.
42:5.0.1.1.9.11.36.41SECTION 493.1262
     493.1262 Standard: Mycobacteriology.
42:5.0.1.1.9.11.36.42SECTION 493.1263
     493.1263 Standard: Mycology.
42:5.0.1.1.9.11.36.43SECTION 493.1264
     493.1264 Standard: Parasitology.
42:5.0.1.1.9.11.36.44SECTION 493.1265
     493.1265 Standard: Virology.
42:5.0.1.1.9.11.36.45SECTION 493.1267
     493.1267 Standard: Routine chemistry.
42:5.0.1.1.9.11.36.46SECTION 493.1269
     493.1269 Standard: Hematology.
42:5.0.1.1.9.11.36.47SECTION 493.1271
     493.1271 Standard: Immunohematology.
42:5.0.1.1.9.11.36.48SECTION 493.1273
     493.1273 Standard: Histopathology.
42:5.0.1.1.9.11.36.49SECTION 493.1274
     493.1274 Standard: Cytology.
42:5.0.1.1.9.11.36.50SECTION 493.1276
     493.1276 Standard: Clinical cytogenetics.
42:5.0.1.1.9.11.36.51SECTION 493.1278
     493.1278 Standard: Histocompatibility.
42:5.0.1.1.9.11.36.52SECTION 493.1281
     493.1281 Standard: Comparison of test results.
42:5.0.1.1.9.11.36.53SECTION 493.1282
     493.1282 Standard: Corrective actions.
42:5.0.1.1.9.11.36.54SECTION 493.1283
     493.1283 Standard: Test records.
42:5.0.1.1.9.11.36.55SECTION 493.1289
     493.1289 Standard: Analytic systems quality assessment.
42:5.0.1.1.9.11.37SUBJGRP 37
  Postanalytic Systems
42:5.0.1.1.9.11.37.56SECTION 493.1290
     493.1290 Condition: Postanalytic systems.
42:5.0.1.1.9.11.37.57SECTION 493.1291
     493.1291 Standard: Test report.
42:5.0.1.1.9.11.37.58SECTION 493.1299
     493.1299 Standard: Postanalytic systems quality assessment.
42:5.0.1.1.9.12SUBPART L
Subpart L [Reserved]
42:5.0.1.1.9.13SUBPART M
Subpart M - Personnel for Nonwaived Testing
42:5.0.1.1.9.13.38SUBJGRP 38
  Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
42:5.0.1.1.9.13.38.1SECTION 493.1351
     493.1351 General.
42:5.0.1.1.9.13.38.2SECTION 493.1353
     493.1353 Scope.
42:5.0.1.1.9.13.38.3SECTION 493.1355
     493.1355 Condition: Laboratories performing PPM procedures; laboratory director.
42:5.0.1.1.9.13.38.4SECTION 493.1357
     493.1357 Standard; laboratory director qualifications.
42:5.0.1.1.9.13.38.5SECTION 493.1359
     493.1359 Standard; PPM laboratory director responsibilities.
42:5.0.1.1.9.13.38.6SECTION 493.1361
     493.1361 Condition: Laboratories performing PPM procedures; testing personnel.
42:5.0.1.1.9.13.38.7SECTION 493.1363
     493.1363 Standard: PPM testing personnel qualifications.
42:5.0.1.1.9.13.38.8SECTION 493.1365
     493.1365 Standard; PPM testing personnel responsibilities.
42:5.0.1.1.9.13.39SUBJGRP 39
  Laboratories Performing Moderate Complexity Testing
42:5.0.1.1.9.13.39.9SECTION 493.1403
     493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director.
42:5.0.1.1.9.13.39.10SECTION 493.1405
     493.1405 Standard; Laboratory director qualifications.
42:5.0.1.1.9.13.39.11SECTION 493.1406
     493.1406 Standard; Laboratory director qualifications on or before February 28, 1992.
42:5.0.1.1.9.13.39.12SECTION 493.1407
     493.1407 Standard; Laboratory director responsibilities.
42:5.0.1.1.9.13.39.13SECTION 493.1409
     493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant.
42:5.0.1.1.9.13.39.14SECTION 493.1411
     493.1411 Standard; Technical consultant qualifications.
42:5.0.1.1.9.13.39.15SECTION 493.1413
     493.1413 Standard; Technical consultant responsibilities.
42:5.0.1.1.9.13.39.16SECTION 493.1415
     493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant.
42:5.0.1.1.9.13.39.17SECTION 493.1417
     493.1417 Standard; Clinical consultant qualifications.
42:5.0.1.1.9.13.39.18SECTION 493.1419
     493.1419 Standard; Clinical consultant responsibilities.
42:5.0.1.1.9.13.39.19SECTION 493.1421
     493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel.
42:5.0.1.1.9.13.39.20SECTION 493.1423
     493.1423 Standard; Testing personnel qualifications.
42:5.0.1.1.9.13.39.21SECTION 493.1425
     493.1425 Standard; Testing personnel responsibilities.
42:5.0.1.1.9.13.40SUBJGRP 40
  Laboratories Performing High Complexity Testing
42:5.0.1.1.9.13.40.22SECTION 493.1441
     493.1441 Condition: Laboratories performing high complexity testing; laboratory director.
42:5.0.1.1.9.13.40.23SECTION 493.1443
     493.1443 Standard; Laboratory director qualifications.
42:5.0.1.1.9.13.40.24SECTION 493.1445
     493.1445 Standard; Laboratory director responsibilities.
42:5.0.1.1.9.13.40.25SECTION 493.1447
     493.1447 Condition: Laboratories performing high complexity testing; technical supervisor.
42:5.0.1.1.9.13.40.26SECTION 493.1449
     493.1449 Standard; Technical supervisor qualifications.
42:5.0.1.1.9.13.40.27SECTION 493.1451
     493.1451 Standard: Technical supervisor responsibilities.
42:5.0.1.1.9.13.40.28SECTION 493.1453
     493.1453 Condition: Laboratories performing high complexity testing; clinical consultant.
42:5.0.1.1.9.13.40.29SECTION 493.1455
     493.1455 Standard; Clinical consultant qualifications.
42:5.0.1.1.9.13.40.30SECTION 493.1457
     493.1457 Standard; Clinical consultant responsibilities.
42:5.0.1.1.9.13.40.31SECTION 493.1459
     493.1459 Condition: Laboratories performing high complexity testing; general supervisor.
42:5.0.1.1.9.13.40.32SECTION 493.1461
     493.1461 Standard: General supervisor qualifications.
42:5.0.1.1.9.13.40.33SECTION 493.1462
     493.1462 General supervisor qualifications on or before February 28, 1992.
42:5.0.1.1.9.13.40.34SECTION 493.1463
     493.1463 Standard: General supervisor responsibilities.
42:5.0.1.1.9.13.40.35SECTION 493.1467
     493.1467 Condition: Laboratories performing high complexity testing; cytology general supervisor.
42:5.0.1.1.9.13.40.36SECTION 493.1469
     493.1469 Standard: Cytology general supervisor qualifications.
42:5.0.1.1.9.13.40.37SECTION 493.1471
     493.1471 Standard: Cytology general supervisor responsibilities.
42:5.0.1.1.9.13.40.38SECTION 493.1481
     493.1481 Condition: Laboratories performing high complexity testing; cytotechnologist.
42:5.0.1.1.9.13.40.39SECTION 493.1483
     493.1483 Standard: Cytotechnologist qualifications.
42:5.0.1.1.9.13.40.40SECTION 493.1485
     493.1485 Standard; Cytotechnologist responsibilities.
42:5.0.1.1.9.13.40.41SECTION 493.1487
     493.1487 Condition: Laboratories performing high complexity testing; testing personnel.
42:5.0.1.1.9.13.40.42SECTION 493.1489
     493.1489 Standard; Testing personnel qualifications.
42:5.0.1.1.9.13.40.43SECTION 493.1491
     493.1491 Technologist qualifications on or before February 28, 1992.
42:5.0.1.1.9.13.40.44SECTION 493.1495
     493.1495 Standard; Testing personnel responsibilities.
42:5.0.1.1.9.14SUBPART N
Subparts N-P [Reserved]
42:5.0.1.1.9.15SUBPART Q
Subpart Q - Inspection
42:5.0.1.1.9.15.41.1SECTION 493.1771
     493.1771 Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories.
42:5.0.1.1.9.15.41.2SECTION 493.1773
     493.1773 Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories.
42:5.0.1.1.9.15.41.3SECTION 493.1775
     493.1775 Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures.
42:5.0.1.1.9.15.41.4SECTION 493.1777
     493.1777 Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance.
42:5.0.1.1.9.15.41.5SECTION 493.1780
     493.1780 Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
42:5.0.1.1.9.16SUBPART R
Subpart R - Enforcement Procedures
42:5.0.1.1.9.16.41.1SECTION 493.1800
     493.1800 Basis and scope.
42:5.0.1.1.9.16.41.2SECTION 493.1804
     493.1804 General considerations.
42:5.0.1.1.9.16.41.3SECTION 493.1806
     493.1806 Available sanctions: All laboratories.
42:5.0.1.1.9.16.41.4SECTION 493.1807
     493.1807 Additional sanctions: Laboratories that participate in Medicare.
42:5.0.1.1.9.16.41.5SECTION 493.1808
     493.1808 Adverse action on any type of CLIA certificate: Effect on Medicare approval.
42:5.0.1.1.9.16.41.6SECTION 493.1809
     493.1809 Limitation on Medicaid payment.
42:5.0.1.1.9.16.41.7SECTION 493.1810
     493.1810 Imposition and lifting of alternative sanctions.
42:5.0.1.1.9.16.41.8SECTION 493.1812
     493.1812 Action when deficiencies pose immediate jeopardy.
42:5.0.1.1.9.16.41.9SECTION 493.1814
     493.1814 Action when deficiencies are at the condition level but do not pose immediate jeopardy.
42:5.0.1.1.9.16.41.10SECTION 493.1816
     493.1816 Action when deficiencies are not at the condition level.
42:5.0.1.1.9.16.41.11SECTION 493.1820
     493.1820 Ensuring timely correction of deficiencies.
42:5.0.1.1.9.16.41.12SECTION 493.1826
     493.1826 Suspension of part of Medicare payments.
42:5.0.1.1.9.16.41.13SECTION 493.1828
     493.1828 Suspension of all Medicare payments.
42:5.0.1.1.9.16.41.14SECTION 493.1832
     493.1832 Directed plan of correction and directed portion of a plan of correction.
42:5.0.1.1.9.16.41.15SECTION 493.1834
     493.1834 Civil money penalty.
42:5.0.1.1.9.16.41.16SECTION 493.1836
     493.1836 State onsite monitoring.
42:5.0.1.1.9.16.41.17SECTION 493.1838
     493.1838 Training and technical assistance for unsuccessful participation in proficiency testing.
42:5.0.1.1.9.16.41.18SECTION 493.1840
     493.1840 Suspension, limitation, or revocation of any type of CLIA certificate.
42:5.0.1.1.9.16.41.19SECTION 493.1842
     493.1842 Cancellation of Medicare approval.
42:5.0.1.1.9.16.41.20SECTION 493.1844
     493.1844 Appeals procedures.
42:5.0.1.1.9.16.41.21SECTION 493.1846
     493.1846 Civil action.
42:5.0.1.1.9.16.41.22SECTION 493.1850
     493.1850 Laboratory registry.
42:5.0.1.1.9.17SUBPART S
Subpart S [Reserved]
42:5.0.1.1.9.18SUBPART T
Subpart T - Consultations
42:5.0.1.1.9.18.41.1SECTION 493.2001
     493.2001 Establishment and function of the Clinical Laboratory Improvement Advisory Committee.
42:5.0.1.1.10PART 494
PART 494 - CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE FACILITIES
42:5.0.1.1.10.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.10.1.41.1SECTION 494.1
     494.1 Basis and scope.
42:5.0.1.1.10.1.41.2SECTION 494.10
     494.10 Definitions.
42:5.0.1.1.10.1.41.3SECTION 494.20
     494.20 Condition: Compliance with Federal, State, and local laws and regulations.
42:5.0.1.1.10.2SUBPART B
Subpart B - Patient Safety
42:5.0.1.1.10.2.41.1SECTION 494.30
     494.30 Condition: Infection control.
42:5.0.1.1.10.2.41.2SECTION 494.40
     494.40 Condition: Water and dialysate quality.
42:5.0.1.1.10.2.41.3SECTION 494.50
     494.50 Condition: Reuse of hemodialyzers and bloodlines.
42:5.0.1.1.10.2.41.4SECTION 494.60
     494.60 Condition: Physical environment.
42:5.0.1.1.10.2.41.5SECTION 494.62
     494.62 Condition of participation: Emergency preparedness.
42:5.0.1.1.10.3SUBPART C
Subpart C - Patient Care
42:5.0.1.1.10.3.41.1SECTION 494.70
     494.70 Condition: Patients' rights.
42:5.0.1.1.10.3.41.2SECTION 494.80
     494.80 Condition: Patient assessment.
42:5.0.1.1.10.3.41.3SECTION 494.90
     494.90 Condition: Patient plan of care.
42:5.0.1.1.10.3.41.4SECTION 494.100
     494.100 Condition: Care at home.
42:5.0.1.1.10.3.41.5SECTION 494.110
     494.110 Condition: Quality assessment and performance improvement.
42:5.0.1.1.10.3.41.6SECTION 494.120
     494.120 Condition: Special purpose renal dialysis facilities.
42:5.0.1.1.10.3.41.7SECTION 494.130
     494.130 Condition: Laboratory services.
42:5.0.1.1.10.4SUBPART D
Subpart D - Administration
42:5.0.1.1.10.4.41.1SECTION 494.140
     494.140 Condition: Personnel qualifications.
42:5.0.1.1.10.4.41.2SECTION 494.150
     494.150 Condition: Responsibilities of the medical director.
42:5.0.1.1.10.4.41.3SECTION 494.160
     494.160 [Reserved]
42:5.0.1.1.10.4.41.4SECTION 494.170
     494.170 Condition: Medical records.
42:5.0.1.1.10.4.41.5SECTION 494.180
     494.180 Condition: Governance.
42:5.0.1.1.11PART 495
PART 495 - STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM
42:5.0.1.1.11.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.11.1.41.1SECTION 495.2
     495.2 Basis and purpose.
42:5.0.1.1.11.1.41.2SECTION 495.4
     495.4 Definitions.
42:5.0.1.1.11.1.41.3SECTION 495.5
     495.5 Requirements for EPs seeking to reverse a hospital-based determination under § 495.4.
42:5.0.1.1.11.1.41.4SECTION 495.20
     495.20 Meaningful use objectives and measures for EPs, eligible hospitals, and CAHs before 2015.
42:5.0.1.1.11.1.41.5SECTION 495.22
     495.22 Meaningful use objectives and measures for EPs, eligible hospitals, and CAHs for 2015 through 2018.
42:5.0.1.1.11.1.41.6SECTION 495.24
     495.24 Stage 3 meaningful use objectives and measures for EPs, eligible hospitals and CAHs for 2019 and subsequent years.
42:5.0.1.1.11.1.41.7SECTION 495.40
     495.40 Demonstration of meaningful use criteria.
42:5.0.1.1.11.1.41.8SECTION 495.60
     495.60 Participation requirements for EPs, eligible hospitals, and CAHs.
42:5.0.1.1.11.2SUBPART B
Subpart B - Requirements Specific to the Medicare Program
42:5.0.1.1.11.2.41.1SECTION 495.100
     495.100 Definitions.
42:5.0.1.1.11.2.41.2SECTION 495.102
     495.102 Incentive payments to EPs.
42:5.0.1.1.11.2.41.3SECTION 495.104
     495.104 Incentive payments to eligible hospitals.
42:5.0.1.1.11.2.41.4SECTION 495.106
     495.106 Incentive payments to CAHs.
42:5.0.1.1.11.2.41.5SECTION 495.108
     495.108 Posting of required information.
42:5.0.1.1.11.2.41.6SECTION 495.110
     495.110 Preclusion on administrative and judicial review.
42:5.0.1.1.11.3SUBPART C
Subpart C - Requirements Specific to Medicare Advantage (MA) Organizations
42:5.0.1.1.11.3.41.1SECTION 495.200
     495.200 Definitions.
42:5.0.1.1.11.3.41.2SECTION 495.202
     495.202 Identification of qualifying MA organizations, MA-EPs and MA-affiliated eligible hospitals.
42:5.0.1.1.11.3.41.3SECTION 495.204
     495.204 Incentive payments to qualifying MA organizations for qualifying MA-EPs and qualifying MA-affiliated eligible hospitals.
42:5.0.1.1.11.3.41.4SECTION 495.206
     495.206 Timeframe for payment to qualifying MA organizations.
42:5.0.1.1.11.3.41.5SECTION 495.208
     495.208 Avoiding duplicate payment.
42:5.0.1.1.11.3.41.6SECTION 495.210
     495.210 Meaningful EHR user attestation.
42:5.0.1.1.11.3.41.7SECTION 495.211
     495.211 Payment adjustments effective for 2015 and subsequent MA payment years with respect to MA EPs and MA-affiliated eligible hospitals.
42:5.0.1.1.11.3.41.8SECTION 495.212
     495.212 Limitation on review.
42:5.0.1.1.11.4SUBPART D
Subpart D - Requirements Specific to the Medicaid Program
42:5.0.1.1.11.4.41.1SECTION 495.300
     495.300 Basis and purpose.
42:5.0.1.1.11.4.41.2SECTION 495.302
     495.302 Definitions.
42:5.0.1.1.11.4.41.3SECTION 495.304
     495.304 Medicaid provider scope and eligibility.
42:5.0.1.1.11.4.41.4SECTION 495.306
     495.306 Establishing patient volume.
42:5.0.1.1.11.4.41.5SECTION 495.308
     495.308 Net average allowable costs as the basis for determining the incentive payment.
42:5.0.1.1.11.4.41.6SECTION 495.310
     495.310 Medicaid provider incentive payments.
42:5.0.1.1.11.4.41.7SECTION 495.312
     495.312 Process for payments.
42:5.0.1.1.11.4.41.8SECTION 495.314
     495.314 Activities required to receive an incentive payment.
42:5.0.1.1.11.4.41.9SECTION 495.316
     495.316 State monitoring and reporting regarding activities required to receive an incentive payment.
42:5.0.1.1.11.4.41.10SECTION 495.318
     495.318 State responsibilities for receiving FFP.
42:5.0.1.1.11.4.41.11SECTION 495.320
     495.320 FFP for payments to Medicaid providers.
42:5.0.1.1.11.4.41.12SECTION 495.322
     495.322 FFP for reasonable administrative expenses.
42:5.0.1.1.11.4.41.13SECTION 495.324
     495.324 Prior approval conditions.
42:5.0.1.1.11.4.41.14SECTION 495.326
     495.326 Disallowance of FFP.
42:5.0.1.1.11.4.41.15SECTION 495.328
     495.328 Request for reconsideration of adverse determination.
42:5.0.1.1.11.4.41.16SECTION 495.330
     495.330 Termination of FFP for failure to provide access to information.
42:5.0.1.1.11.4.41.17SECTION 495.332
     495.332 State Medicaid health information technology (HIT) plan requirements.
42:5.0.1.1.11.4.41.18SECTION 495.334
     495.334 [Reserved]
42:5.0.1.1.11.4.41.19SECTION 495.336
     495.336 Health information technology planning advance planning document requirements (HIT PAPD).
42:5.0.1.1.11.4.41.20SECTION 495.338
     495.338 Health information technology implementation advance planning document requirements (HIT IAPD).
42:5.0.1.1.11.4.41.21SECTION 495.340
     495.340 As-needed HIT PAPD update and as-needed HIT IAPD update requirements.
42:5.0.1.1.11.4.41.22SECTION 495.342
     495.342 Annual HIT IAPD requirements.
42:5.0.1.1.11.4.41.23SECTION 495.344
     495.344 Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD and update, and the annual HIT IAPD.
42:5.0.1.1.11.4.41.24SECTION 495.346
     495.346 Access to systems and records.
42:5.0.1.1.11.4.41.25SECTION 495.348
     495.348 Procurement standards.
42:5.0.1.1.11.4.41.26SECTION 495.350
     495.350 State Medicaid agency attestations.
42:5.0.1.1.11.4.41.27SECTION 495.352
     495.352 Reporting requirements.
42:5.0.1.1.11.4.41.28SECTION 495.354
     495.354 Rules for charging equipment.
42:5.0.1.1.11.4.41.29SECTION 495.356
     495.356 Nondiscrimination requirements.
42:5.0.1.1.11.4.41.30SECTION 495.358
     495.358 Cost allocation plans.
42:5.0.1.1.11.4.41.31SECTION 495.360
     495.360 Software and ownership rights.
42:5.0.1.1.11.4.41.32SECTION 495.362
     495.362 Retroactive approval of FFP with an effective date of February 18, 2009.
42:5.0.1.1.11.4.41.33SECTION 495.364
     495.364 Review and assessment of administrative activities and expenses of Medicaid provider health information technology adoption and operation.
42:5.0.1.1.11.4.41.34SECTION 495.366
     495.366 Financial oversight and monitoring of expenditures.
42:5.0.1.1.11.4.41.35SECTION 495.368
     495.368 Combating fraud and abuse.
42:5.0.1.1.11.4.41.36SECTION 495.370
     495.370 Appeals process for a Medicaid provider receiving electronic health record incentive payments.
42:5.0.1.1.12PART 498
PART 498 - APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE MEDICAID PROGRAM
42:5.0.1.1.12.1SUBPART A
Subpart A - General Provisions
42:5.0.1.1.12.1.41.1SECTION 498.1
     498.1 Statutory basis.
42:5.0.1.1.12.1.41.2SECTION 498.2
     498.2 Definitions.
42:5.0.1.1.12.1.41.3SECTION 498.3
     498.3 Scope and applicability.
42:5.0.1.1.12.1.41.4SECTION 498.4
     498.4 NFs subject to appeals process in part 498.
42:5.0.1.1.12.1.41.5SECTION 498.5
     498.5 Appeal rights.
42:5.0.1.1.12.1.41.6SECTION 498.10
     498.10 Appointment of representatives.
42:5.0.1.1.12.1.41.7SECTION 498.11
     498.11 Authority of representatives.
42:5.0.1.1.12.1.41.8SECTION 498.13
     498.13 Fees for services of representatives.
42:5.0.1.1.12.1.41.9SECTION 498.15
     498.15 Charge for transcripts.
42:5.0.1.1.12.1.41.10SECTION 498.17
     498.17 Filing of briefs with the ALJ or Departmental Appeals Board, and opportunity for rebuttal.
42:5.0.1.1.12.2SUBPART B
Subpart B - Initial, Reconsidered, and Revised Determinations
42:5.0.1.1.12.2.41.1SECTION 498.20
     498.20 Notice and effect of initial determinations.
42:5.0.1.1.12.2.41.2SECTION 498.22
     498.22 Reconsideration.
42:5.0.1.1.12.2.41.3SECTION 498.23
     498.23 Withdrawal of request for reconsideration.
42:5.0.1.1.12.2.41.4SECTION 498.24
     498.24 Reconsidered determination.
42:5.0.1.1.12.2.41.5SECTION 498.25
     498.25 Notice and effect of reconsidered determination.
42:5.0.1.1.12.3SUBPART C
Subpart C - Reopening of Initial or Reconsidered Determinations
42:5.0.1.1.12.3.41.1SECTION 498.30
     498.30 Limitation on reopening.
42:5.0.1.1.12.3.41.2SECTION 498.32
     498.32 Notice and effect of reopening and revision.
42:5.0.1.1.12.4SUBPART D
Subpart D - Hearings
42:5.0.1.1.12.4.41.1SECTION 498.40
     498.40 Request for hearing.
42:5.0.1.1.12.4.41.2SECTION 498.42
     498.42 Parties to the hearing.
42:5.0.1.1.12.4.41.3SECTION 498.44
     498.44 Designation of hearing official.
42:5.0.1.1.12.4.41.4SECTION 498.45
     498.45 Disqualification of Administrative Law Judge.
42:5.0.1.1.12.4.41.5SECTION 498.47
     498.47 Prehearing conference.
42:5.0.1.1.12.4.41.6SECTION 498.48
     498.48 Notice of prehearing conference.
42:5.0.1.1.12.4.41.7SECTION 498.49
     498.49 Conduct of prehearing conference.
42:5.0.1.1.12.4.41.8SECTION 498.50
     498.50 Record, order, and effect of prehearing conference.
42:5.0.1.1.12.4.41.9SECTION 498.52
     498.52 Time and place of hearing.
42:5.0.1.1.12.4.41.10SECTION 498.53
     498.53 Change in time and place of hearing.
42:5.0.1.1.12.4.41.11SECTION 498.54
     498.54 Joint hearings.
42:5.0.1.1.12.4.41.12SECTION 498.56
     498.56 Hearing on new issues.
42:5.0.1.1.12.4.41.13SECTION 498.58
     498.58 Subpoenas.
42:5.0.1.1.12.4.41.14SECTION 498.60
     498.60 Conduct of hearing.
42:5.0.1.1.12.4.41.15SECTION 498.61
     498.61 Evidence.
42:5.0.1.1.12.4.41.16SECTION 498.62
     498.62 Witnesses.
42:5.0.1.1.12.4.41.17SECTION 498.63
     498.63 Oral and written summation.
42:5.0.1.1.12.4.41.18SECTION 498.64
     498.64 Record of hearing.
42:5.0.1.1.12.4.41.19SECTION 498.66
     498.66 Waiver of right to appear and present evidence.
42:5.0.1.1.12.4.41.20SECTION 498.68
     498.68 Dismissal of request for hearing.
42:5.0.1.1.12.4.41.21SECTION 498.69
     498.69 Dismissal for abandonment.
42:5.0.1.1.12.4.41.22SECTION 498.70
     498.70 Dismissal for cause.
42:5.0.1.1.12.4.41.23SECTION 498.71
     498.71 Notice and effect of dismissal and right to request review.
42:5.0.1.1.12.4.41.24SECTION 498.72
     498.72 Vacating a dismissal of request for hearing.
42:5.0.1.1.12.4.41.25SECTION 498.74
     498.74 Administrative Law Judge's decision.
42:5.0.1.1.12.4.41.26SECTION 498.76
     498.76 Removal of hearing to Departmental Appeals Board.
42:5.0.1.1.12.4.41.27SECTION 498.78
     498.78 Remand by the Administrative Law Judge.
42:5.0.1.1.12.4.41.28SECTION 498.79
     498.79 Timeframes for deciding an enrollment appeal before an ALJ.
42:5.0.1.1.12.5SUBPART E
Subpart E - Departmental Appeals Board Review
42:5.0.1.1.12.5.41.1SECTION 498.80
     498.80 Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.
42:5.0.1.1.12.5.41.2SECTION 498.82
     498.82 Request for Departmental Appeals Board review.
42:5.0.1.1.12.5.41.3SECTION 498.83
     498.83 Departmental Appeals Board action on request for review.
42:5.0.1.1.12.5.41.4SECTION 498.85
     498.85 Procedures before the Departmental Appeals Board on review.
42:5.0.1.1.12.5.41.5SECTION 498.86
     498.86 Evidence admissible on review.
42:5.0.1.1.12.5.41.6SECTION 498.88
     498.88 Decision or remand by the Departmental Appeals Board.
42:5.0.1.1.12.5.41.7SECTION 498.90
     498.90 Effect of Departmental Appeals Board decision.
42:5.0.1.1.12.5.41.8SECTION 498.95
     498.95 Extension of time for seeking judicial review.
42:5.0.1.1.12.6SUBPART F
Subpart F - Reopening of Decisions Made by Administrative Law Judges or the Departmental Appeals Board
42:5.0.1.1.12.6.41.1SECTION 498.100
     498.100 Basis, timing, and authority for reopening an ALJ or Board decision.
42:5.0.1.1.12.6.41.2SECTION 498.102
     498.102 Revision of reopened decision.
42:5.0.1.1.12.6.41.3SECTION 498.103
     498.103 Notice and effect of revised decision.