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.
§ 405.750 - Time period for reopening initial, revised, or reconsidered determinations and decisions or revised decisions of an ALJ or the Departmental Appeals Board (DAB); binding effect of determination and decisions.
§ 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.
Retrospective Appeals for Changes in Patient Status That Resulted in Denial of Part A Coverage for Hospital Services
§ 405.931 - Scope, basis, and definitions.
§ 405.932 - Right to appeal a denial of Part A coverage resulting from a change in patient status.
§ 405.934 - Reconsideration.
§ 405.936 - Hearings before an ALJ and decisions by an ALJ or Attorney Adjudicator.
§ 405.938 - Review by the Medicare Appeals Council and judicial review.
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 - Procedures and Beneficiary Rights for Expedited Determinations and Reconsiderations When Coverage is Changed or Terminated
§ 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.
§ 405.1210 - Notifying eligible beneficiaries of appeal rights when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.
§ 405.1211 - Expedited determination procedures when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.
§ 405.1212 - Expedited reconsideration procedures regarding Part A coverage when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.
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.