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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 42 - Public Health |
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Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
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SubChapter B - Medicare Program |
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Part 405 - Federal Health Insurance for the Aged and Disabled |
| Subpart A - XXX |
| Subpart B - Medical Services Coverage Decisions That Relate to Health Care Technology |
| § 405.201 - Scope of subpart and definitions. |
| § 405.203 - FDA categorization of investigational devices. |
| § 405.205 - Coverage of a Category B (Nonexperimental/investigational) device. |
| § 405.207 - Services related to a noncovered device. |
| § 405.209 - Payment for a Category B (Nonexperimental/investigational) device. |
| § 405.211 - Coverage of items and services in FDA-approved IDE studies. |
| § 405.212 - Medicare Coverage IDE study criteria. |
| § 405.213 - Re-evaluation of a device categorization. |
| § 405.215 - Confidential commercial and trade secret information. |
| Subpart C - Suspension of Payment, Recovery of Overpayments, and Repayment of Scholarships and Loans |
| Repayment of Scholarships and Loans |
| § 405.380 - Collection of past-due amounts on scholarship and loan programs. |
| Liability for Payments to Providers or Suppliers and Handling of Incorrect Payments |
| § 405.350 - Individual's liability for payments made to providers and other persons for items and services furnished the individual. |
| § 405.351 - Incorrect payments for which the individual is not liable. |
| § 405.352 - Adjustment of title XVIII incorrect payments. |
| § 405.353 - Certification of amount that will be adjusted against individual title II or railroad retirement benefits. |
| § 405.354 - Procedures for adjustment or recovery - title II beneficiary. |
| § 405.355 - Waiver of adjustment or recovery. |
| § 405.356 - Principles applied in waiver of adjustment or recovery. |
| § 405.357 - Notice of right to waiver consideration. |
| § 405.358 - When waiver of adjustment or recovery may be applied. |
| § 405.359 - Liability of certifying or disbursing officer. |
| Suspension and Recoupment of Payment to Providers and Suppliers and Collection and Compromise of Overpayments |
| § 405.370 - Definitions. |
| § 405.371 - Suspension, offset, and recoupment of Medicare payments to providers and suppliers of services. |
| § 405.372 - Proceeding for suspension of payment. |
| § 405.373 - Proceeding for offset or recoupment. |
| § 405.374 - Opportunity for rebuttal. |
| § 405.375 - Time limits for, and notification of, administrative determination after receipt of rebuttal statement. |
| § 405.376 - Suspension and termination of collection action and compromise of claims for overpayment. |
| § 405.377 - Withholding Medicare payments to recover Medicaid overpayments. |
| § 405.378 - Interest charges on overpayment and underpayments to providers, suppliers, and other entities. |
| § 405.379 - Limitation on recoupment of provider and supplier overpayments. |
| General Provisions |
| § 405.301 - Scope of subpart. |
| Suspension of Payment to Providers and Suppliers and Collection and Compromise of Overpayments |
| Subpart D - Private Contracts |
| § 405.400 - Definitions. |
| § 405.405 - General rules. |
| § 405.410 - Conditions for properly opting-out of Medicare. |
| § 405.415 - Requirements of the private contract. |
| § 405.420 - Requirements of the opt-out affidavit. |
| § 405.425 - Effects of opting-out of Medicare. |
| § 405.430 - Failure to properly opt-out. |
| § 405.435 - Failure to maintain opt-out. |
| § 405.440 - Emergency and urgent care services. |
| § 405.445 - Cancellation of opt-out and early termination of opt-out. |
| § 405.450 - Appeals. |
| § 405.455 - Application to Medicare Advantage contracts. |
| Subpart E - Criteria for Determining Reasonable Charges |
| § 405.500 - Basis. |
| § 405.501 - Determination of reasonable charges. |
| § 405.502 - Criteria for determining reasonable charges. |
| § 405.503 - Determining customary charges. |
| § 405.504 - Determining prevailing charges. |
| § 405.505 - Determination of locality. |
| § 405.506 - Charges higher than customary or prevailing charges or lowest charge levels. |
| § 405.507 - Illustrations of the application of the criteria for determining reasonable charges. |
| § 405.508 - Determination of comparable circumstances; limitation. |
| § 405.509 - Determining the inflation-indexed charge. |
| § 405.511 - Reasonable charges for medical services, supplies, and equipment. |
| § 405.512 - Carriers' procedural terminology and coding systems. |
| § 405.515 - Reimbursement for clinical laboratory services billed by physicians. |
| § 405.517 - Payment for drugs and biologicals that are not paid on a cost or prospective payment basis. |
| § 405.520 - Payment for a physician assistant's, nurse practitioner's, and clinical nurse specialists' services and services furnished incident to their professional services. |
| § 405.534 - Limitation on payment for screening mammography services. |
| § 405.535 - Special rule for nonparticipating physicians and suppliers furnishing screening mammography services before January 1, 2002. |
| Subpart F - XXX |
| Subparts F--G - XXX |
| Subpart G - XXX |
| § 405.701 - Basis, purpose and definitions. |
| § 405.702 - Notice of initial determination. |
| § 405.704 - Actions which are initial determinations. |
| § 405.705 - Actions which are not initial determinations. |
| § 405.706 - Decisions of utilization review committees. |
| § 405.708 - Effect of initial determination. |
| § 405.710 - Right to reconsideration. |
| § 405.711 - Time and place of filing request for reconsideration. |
| § 405.712 - Extension of time to request reconsideration. |
| § 405.714 - Withdrawal of request for reconsideration. |
| § 405.715 - Reconsidered determination. |
| § 405.716 - Notice of reconsidered determination. |
| § 405.717 - Effect of a reconsidered determination. |
| § 405.718 - Expedited appeals process. |
| § 405.720 - Hearing; right to hearing. |
| § 405.722 - Time and place of filing request for a hearing. |
| § 405.724 - Departmental Appeals Board (DAB) review. |
| § 405.730 - Court review. |
| § 405.732 - Review of a national coverage determination (NCD). |
| § 405.740 - Principles for determining the amount in controversy. |
| § 405.745 - Amount in controversy ascertained after reconsideration. |
| § 405.747 - Dismissal of request for hearing; amount in controversy less than $100. |
| § 405.753 - Appeal of a categorization of a device. |
| § 405.718a - Expedited appeals process; place and time of filing request. |
| § 405.718b - Expedited appeals process; parties. |
| § 405.718c - Expedited appeals process; agreement requirements. |
| § 405.718d - Expedited appeals process; effect of agreement. |
| § 405.718e - Effect of a request that does not result in agreement. |
| Subpart H - Appeals Under the Medicare Part B Program |
| § 405.800 - Appeals of CMS or a CMS contractor. |
| § 405.801 - Part B appeals—general description. |
| § 405.802 - Definitions. |
| § 405.803 - Appeals rights. |
| § 405.804 - Notice of initial determination. |
| § 405.805 - Parties to the initial determination. |
| § 405.806 - Impact of reversal of contractor determinations on claims processing. |
| § 405.807 - Request for review of initial determination. |
| § 405.808 - Parties to the review. |
| § 405.809 - Reinstatement of provider or supplier billing privileges following corrective action. |
| § 405.810 - Review determination. |
| § 405.811 - Notice of review determination. |
| § 405.812 - Effective date for DMEPOS supplier's billing privileges. |
| § 405.815 - Submission of claims. |
| § 405.817 - Principles for determining amount in controversy. |
| § 405.818 - Deadline for processing provider enrollment initial determinations. |
| § 405.821 - Request for carrier hearing. |
| § 405.822 - Parties to a carrier hearing. |
| § 405.823 - Carrier hearing officer. |
| § 405.824 - Disqualification of carrier hearing officer. |
| § 405.825 - Location of carrier hearing. |
| § 405.826 - Notice of carrier hearing. |
| § 405.830 - Conduct of the carrier hearing. |
| § 405.831 - Waiver of right to appear at carrier hearing and present evidence. |
| § 405.832 - Dismissal of request for carrier hearing. |
| § 405.833 - Record of carrier hearing. |
| § 405.834 - Carrier hearing officer's decision. |
| § 405.835 - Effect of carrier hearing officer's decision. |
| § 405.836 - Authority of the carrier hearing officer. |
| § 405.841 - Reopening initial or review determination of the carrier, and decision of a carrier hearing officer. |
| § 405.842 - Notice of reopening and revision. |
| § 405.850 - Change of ruling or legal precedent. |
| § 405.853 - Expedited appeals process. |
| § 405.855 - ALJ hearing. |
| § 405.856 - Departmental Appeals Board (DAB) review. |
| § 405.857 - Court review. |
| § 405.860 - Review of a national coverage determination (NCD). |
| § 405.870 - Appointment of representative. |
| § 405.871 - Qualifications of representatives. |
| § 405.872 - Authority of representatives. |
| § 405.874 - Appeals of CMS or a CMS contractor. |
| § 405.877 - Appeal of a categorization of a device. |
| Subpart I - Determinations, Redeterminations, Reconsiderations, and Appeals Under Original Medicare (Part A and Part B) |
| § 405.900 - Basis and scope. |
| § 405.902 - Definitions. |
| § 405.903 - xxx |
| § 405.904 - Medicare initial determinations, redeterminations and appeals: General description. |
| § 405.906 - Parties to the initial determinations, redeterminations, reconsiderations, hearings, and reviews. |
| § 405.908 - Medicaid State agencies. |
| § 405.910 - Appointed representatives. |
| § 405.912 - Assignment of appeal rights. |
| Applicability of Medicare Coverage Policies |
| § 405.1060 - Applicability of national coverage determinations (NCDs). |
| § 405.1062 - Applicability of local coverage determinations and other policies not binding on the ALJ or attorney adjudicator and Council. |
| § 405.1063 - Applicability of laws, regulations, CMS Rulings, and precedential decisions. |
| § 405.1064 - ALJ decisions involving statistical samples. |
| Initial Determinations |
| § 405.920 - Initial determinations. |
| § 405.921 - Notice of initial determination. |
| § 405.922 - Time frame for processing initial determinations. |
| § 405.924 - Actions that are initial determinations. |
| § 405.925 - Decisions of utilization review committees. |
| § 405.926 - Actions that are not initial determinations. |
| § 405.927 - Initial determinations subject to the reopenings process. |
| § 405.928 - Effect of the initial determination. |
| § 405.929 - Post-payment review. |
| § 405.930 - Failure to respond to additional documentation request. |
| §§ 405.929--405.930 - xxx |
| Reopenings |
| § 405.980 - Reopening of initial determinations, redeterminations, reconsiderations, decisions, and reviews. |
| § 405.982 - Notice of a revised determination or decision. |
| § 405.984 - Effect of a revised determination or decision. |
| § 405.986 - Good cause for reopening. |
| Expedited Access to Judicial Review |
| § 405.990 - Expedited access to judicial review. |
| Redeterminations |
| § 405.940 - Right to a redetermination. |
| § 405.942 - Time frame for filing a request for a redetermination. |
| § 405.944 - Place and method of filing a request for a redetermination. |
| § 405.946 - Evidence to be submitted with the redetermination request. |
| § 405.947 - Notice to the beneficiary of applicable plan's request for a redetermination. |
| § 405.948 - Conduct of a redetermination. |
| § 405.950 - Time frame for making a redetermination. |
| § 405.952 - Withdrawal or dismissal of a request for a redetermination. |
| § 405.954 - Redetermination. |
| § 405.956 - Notice of a redetermination. |
| § 405.958 - Effect of a redetermination. |
| Reconsideration |
| § 405.960 - Right to a reconsideration. |
| § 405.962 - Timeframe for filing a request for a reconsideration. |
| § 405.964 - Place and method of filing a request for a reconsideration. |
| § 405.966 - Evidence to be submitted with the reconsideration request. |
| § 405.968 - Conduct of a reconsideration. |
| § 405.970 - Timeframe for making a reconsideration following a contractor redetermination. |
| § 405.972 - Withdrawal or dismissal of a request for reconsideration or review of a contractor's dismissal of a request for redetermination. |
| § 405.974 - Reconsideration and review of a contractor's dismissal of a request for redetermination. |
| § 405.976 - Notice of a reconsideration. |
| § 405.978 - Effect of a reconsideration. |
| ALJ Hearings |
| § 405.1000 - Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule. |
| § 405.1002 - Right to an ALJ hearing. |
| § 405.1004 - Right to a review of QIC notice of dismissal. |
| § 405.1006 - Amount in controversy required for an ALJ hearing and judicial review. |
| § 405.1008 - Parties to the proceedings on a request for an ALJ hearing. |
| § 405.1010 - When CMS or its contractors may participate in the proceedings on a request for an ALJ hearing. |
| § 405.1012 - When CMS or its contractors may be a party to a hearing. |
| § 405.1014 - Request for an ALJ hearing or a review of a QIC dismissal. |
| § 405.1016 - Time frames for deciding an appeal of a QIC reconsideration or escalated request for a QIC reconsideration. |
| § 405.1018 - Submitting evidence. |
| § 405.1020 - Time and place for a hearing before an ALJ. |
| § 405.1022 - Notice of a hearing before an ALJ. |
| § 405.1024 - Objections to the issues. |
| § 405.1026 - Disqualification of the ALJ or attorney adjudicator. |
| § 405.1028 - Review of evidence submitted by parties. |
| § 405.1030 - ALJ hearing procedures. |
| § 405.1032 - Issues before an ALJ or attorney adjudicator. |
| § 405.1034 - Requesting information from the QIC. |
| § 405.1036 - Description of an ALJ hearing process. |
| § 405.1037 - Discovery. |
| § 405.1038 - Deciding a case without a hearing before an ALJ. |
| § 405.1040 - Prehearing and posthearing conferences. |
| § 405.1042 - The administrative record. |
| § 405.1044 - Consolidated proceedings. |
| § 405.1046 - Notice of an ALJ or attorney adjudicator decision. |
| § 405.1048 - The effect of an ALJ's or attorney adjudicator's decision. |
| § 405.1050 - Removal of a hearing request from OMHA to the Council. |
| § 405.1052 - Dismissal of a request for a hearing before an ALJ or request for review of a QIC dismissal. |
| § 405.1054 - Effect of dismissal of a request for a hearing or request for review of QIC dismissal. |
| § 405.1056 - xxx |
| § 405.1058 - xxx |
| Medicare Appeals Council Review |
| § 405.1100 - Medicare Appeals Council review: General. |
| § 405.1102 - Request for Council review when ALJ or attorney adjudicator issues decision or dismissal. |
| § 405.1104 - Request for MAC review when an ALJ does not issue a decision timely. |
| § 405.1106 - Where a request for review or escalation may be filed. |
| § 405.1108 - Council actions when request for review or escalation is filed. |
| § 405.1110 - Council reviews on its own motion. |
| § 405.1112 - Content of request for review. |
| § 405.1114 - Dismissal of request for review. |
| § 405.1116 - Effect of dismissal of request for Council review or request for hearing. |
| § 405.1118 - Obtaining evidence from the Council. |
| § 405.1120 - Filing briefs with the Council. |
| § 405.1122 - What evidence may be submitted to the Council. |
| § 405.1124 - Oral argument. |
| § 405.1126 - Case remanded by the Council. |
| § 405.1128 - Action of the Council. |
| § 405.1130 - Effect of the Council's decision. |
| § 405.1132 - Request for escalation to Federal court. |
| § 405.1134 - Extension of time to file action in Federal district court. |
| § 405.1136 - Judicial review. |
| § 405.1138 - Case remanded by a Federal district court. |
| § 405.1140 - Council review of ALJ decision in a case remanded by a Federal district court. |
| Subpart J - Expedited Determinations and Reconsiderations of Provider Service Terminations, and Procedures for Inpatient Hospital Discharges |
| § 405.1200 - Notifying beneficiaries of provider service terminations. |
| § 405.1202 - Expedited determination procedures. |
| § 405.1204 - Expedited reconsiderations. |
| § 405.1205 - Notifying beneficiaries of hospital discharge appeal rights. |
| § 405.1206 - Expedited determination procedures for inpatient hospital care. |
| § 405.1208 - Hospital requests expedited QIO review. |
| Subparts K--Q - XXX |
| Subpart R - Provider Reimbursement Determinations and Appeals |
| § 405.1801 - Introduction. |
| § 405.1803 - Contractor determination and notice of amount of program reimbursement. |
| § 405.1804 - Matters not subject to administrative and judicial review under prospective payment. |
| § 405.1805 - Parties to contractor determination. |
| § 405.1807 - Effect of contractor determination. |
| § 405.1809 - Contractor hearing procedures. |
| § 405.1811 - Right to contractor hearing; contents of, and adding issues to, hearing request. |
| § 405.1813 - Good cause extension of time limit for requesting a contractor hearing. |
| § 405.1814 - Contractor hearing officer jurisdiction. |
| § 405.1815 - Parties to proceedings before the contractor hearing officer(s). |
| § 405.1817 - Hearing officer or panel of hearing officers authorized to conduct contractor hearing; disqualification of officers. |
| § 405.1819 - Conduct of contractor hearing. |
| § 405.1821 - Prehearing discovery and other proceedings prior to the contractor hearing. |
| § 405.1823 - Evidence at contractor hearing. |
| § 405.1825 - Witnesses at contractor hearing. |
| § 405.1827 - Record of proceedings before the contractor hearing officer(s). |
| § 405.1829 - Scope of authority of contractor hearing officer(s). |
| § 405.1831 - Contractor hearing decision. |
| § 405.1832 - Contractor hearing officer review of compliance with the substantive reimbursement requirement of an appropriate cost report claim. |
| § 405.1833 - Effect of contractor hearing decision. |
| § 405.1834 - CMS reviewing official procedure. |
| § 405.1835 - Right to Board hearing; contents of, and adding issues to, hearing request. |
| § 405.1836 - Good cause extension of time limit for requesting a Board hearing. |
| § 405.1837 - Group appeals. |
| § 405.1839 - Amount in controversy. |
| § 405.1840 - Board jurisdiction. |
| § 405.1841 - Time, place, form, and content of request for Board hearing. |
| § 405.1842 - Expedited judicial review. |
| § 405.1843 - Parties to proceedings in a Board appeal. |
| § 405.1845 - Composition of Board; hearings, decisions, and remands. |
| § 405.1847 - Disqualification of Board members. |
| § 405.1849 - Establishment of time and place of hearing by the Board. |
| § 405.1851 - Conduct of Board hearing. |
| § 405.1853 - Board proceedings prior to any hearing; discovery. |
| § 405.1855 - Evidence at Board hearing. |
| § 405.1857 - Subpoenas. |
| § 405.1859 - Witnesses. |
| § 405.1861 - Oral argument and written allegations. |
| § 405.1863 - Administrative policy at issue. |
| § 405.1865 - Record of administrative proceedings. |
| § 405.1867 - Scope of Board's legal authority. |
| § 405.1868 - Board actions in response to failure to follow Board rules. |
| § 405.1869 - Scope of Board's authority in a hearing decision. |
| § 405.1871 - Board hearing decision. |
| § 405.1873 - Board review of compliance with the reimbursement requirement of an appropriate cost report claim. |
| § 405.1875 - Administrator review. |
| § 405.1877 - Judicial review. |
| § 405.1881 - Appointment of representative. |
| § 405.1883 - Authority of representative. |
| § 405.1885 - Reopening a contractor determination or reviewing entity decision. |
| § 405.1887 - Notice of reopening; effect of reopening. |
| § 405.1889 - Effect of a revision; issue-specific nature of appeals of revised determinations and decisions. |
| Subparts S--T - XXX |
| Subpart U - Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services |
| § 405.2100 - Scope of subpart. |
| §§ 405.2100--405.2101 - [Reserved] |
| § 405.2101 - Objectives of the end-stage renal disease (ESRD) program. |
| § 405.2102 - Definitions. |
| § 405.2110 - Designation of ESRD networks. |
| § 405.2111 - [Reserved] |
| § 405.2112 - ESRD network organizations. |
| § 405.2113 - Medical review board. |
| § 405.2114 - [Reserved] |
| § 405.2120 - Minimum utilization rates: general. |
| § 405.2121 - Basis for determining minimum utilization rates. |
| § 405.2122 - Types and duration of classification according to utilization rates. |
| § 405.2123 - Reporting of utilization rates for classification. |
| § 405.2124 - Calculation of utilization rates for comparison with minimal utilization rate(s) and notification of status. |
| § 405.2130 - Condition: Minimum utilization rates. |
| § 405.2131 - Condition: Provider status: Renal transplantation center or renal dialysis center. |
| § 405.2132 - [Reserved] |
| § 405.2133 - Condition: Furnishing data and information for ESRD program administration. |
| § 405.2134 - Condition: Participation in network activities. |
| § 405.2135 - Condition: Compliance with Federal, State and local laws and regulations. |
| § 405.2136 - Condition: Governing body and management. |
| § 405.2137 - Condition: Patient long-term program and patient care plan. |
| § 405.2138 - Condition: Patients' rights and responsibilities. |
| § 405.2139 - Condition: Medical records. |
| § 405.2140 - Condition: Physical environment. |
| § 405.2150 - Condition: Reuse of hemodialyzers and other dialysis supplies. |
| § 405.2160 - Condition: Affiliation agreement or arrangement. |
| § 405.2161 - Condition: Director of a renal dialysis facility or renal dialysis center. |
| § 405.2162 - Condition: Staff of a renal dialysis facility or renal dialysis center. |
| § 405.2163 - Condition: Minimal service requirements for a renal dialysis facility or renal dialysis center. |
| § 405.2164 - Conditions for coverage of special purpose renal dialysis facilities. |
| § 405.2170 - Condition: Director of a renal transplantation center. |
| § 405.2171 - Condition: Minimal service requirements for a renal transplantation center. |
| § 405.2180 - Termination of Medicare coverage. |
| § 405.2181 - Alternative sanctions. |
| § 405.2182 - Notice of sanction and appeal rights: Termination of coverage. |
| § 405.2184 - Notice of appeal rights: Alternative sanctions. |
| §§ 405.2131--405.2184 - [Reserved] |
| Subparts V--W - XXX |
| Subpart X - Rural Health Clinic and Federally Qualified Health Center Services |
| § 405.2400 - Basis. |
| § 405.2401 - Scope and definitions. |
| § 405.2402 - Rural health clinic basic requirements. |
| § 405.2403 - Rural health clinic content and terms of the agreement with the Secretary. |
| § 405.2404 - Termination of rural health clinic agreements. |
| § 405.2410 - Application of Part B deductible and coinsurance. |
| § 405.2411 - Scope of benefits. |
| § 405.2412 - Physicians' services. |
| § 405.2413 - Services and supplies incident to a physician's services. |
| § 405.2414 - Nurse practitioner, physician assistant, and certified nurse midwife services. |
| § 405.2415 - Incident to services and direct supervision. |
| § 405.2416 - Visiting nurse services. |
| § 405.2417 - Visiting nurse services: Determination of shortage of agencies. |
| Federally Qualified Health Center Services |
| § 405.2430 - Basic requirements. |
| § 405.2434 - Content and terms of the agreement. |
| § 405.2436 - Termination of agreement. |
| § 405.2440 - Conditions for reinstatement after termination by CMS. |
| § 405.2442 - Notice to the public. |
| § 405.2444 - Change of ownership. |
| § 405.2446 - Scope of services. |
| § 405.2448 - Preventive primary services. |
| § 405.2449 - Preventive services. |
| § 405.2450 - Clinical psychologist, clinical social worker, marriage and family therapist, and mental health counselor services. |
| § 405.2452 - Services and supplies incident to clinical psychologist, clinical social worker, marriage and family therapist, and mental health counselor services. |
| Payment for Rural Health Clinic and Federally Qualified Health Center Services |
| § 405.2460 - Applicability of general payment exclusions. |
| § 405.2462 - Payment for RHC and FQHC services. |
| § 405.2463 - What constitutes a visit. |
| § 405.2464 - Payment rate. |
| § 405.2466 - Annual reconciliation. |
| § 405.2467 - Requirements of the FQHC PPS. |
| § 405.2468 - Allowable costs. |
| § 405.2469 - FQHC supplemental payments. |
| § 405.2470 - Reports and maintenance of records. |
| § 405.2472 - Beneficiary appeals. |