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