42 C.F.R. PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
TITLE 42--Public Health
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--MEDICARE PROGRAM
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart A--[RESERVED]
Subpart B--MEDICAL SERVICES COVERAGE DECISIONS THAT RELATE TO HEALTH CARE TECHNOLOGY
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| Scope of subpart and definitions.
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| FDA categorization of investigational devices.
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| Coverage of a non-experimental/investigational (Category B) device.
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| Services related to a noncovered device.
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| Payment for a non-experimental/investigational (Category B) device.
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| Procedures for Medicare contractors in making coverage decisions for a non-experimental/investigational (Category B) device.
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| Re-evaluation of a device categorization.
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| Confidential commercial and trade secret information.
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Subpart C--SUSPENSION OF PAYMENT, RECOVERY OF OVERPAYMENTS, AND REPAYMENT OF SCHOLARSHIPS AND LOANS
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| Individual's liability for payments made to providers and other persons for items and services furnished the individual.
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| Incorrect payments for which the individual is not liable.
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| Adjustment of title XVIII incorrect payments.
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| Certification of amount that will be adjusted against individual title II or railroad retirement benefits.
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| Procedures for adjustment or recovery--title II beneficiary.
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| Waiver of adjustment or recovery.
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| Principles applied in waiver of adjustment or recovery.
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| Notice of right to waiver consideration.
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| When waiver of adjustment or recovery may be applied.
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| Liability of certifying or disbursing officer.
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| Suspension, offset, and recoupment of Medicare payments to providers and suppliers of services.
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| Proceeding for suspension of payment.
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| Proceeding for offset or recoupment.
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| Opportunity for rebuttal.
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| Time limits for, and notification of, administrative determination after receipt of rebuttal statement.
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| Suspension and termination of collection action and compromise of claims for overpayment.
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| Withholding Medicare payments to recover Medicaid overpayments.
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| Interest charges on overpayment and underpayments to providers, suppliers, and other entities.
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| Collection of past-due amounts on scholarship and loan programs.
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Subpart D--PRIVATE CONTRACTS
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| Conditions for properly opting-out of Medicare.
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| Requirements of the private contract.
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| Requirements of the opt-out affidavit.
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| Effects of opting-out of Medicare.
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| Failure to properly opt-out.
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| Failure to maintain opt-out.
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| Emergency and urgent care services.
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| Renewal and early termination of opt-out.
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| Application to Medicare+Choice contracts.
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Subpart E--CRITERIA FOR DETERMINING REASONABLE CHARGES
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| Determination of reasonable charges.
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| Criteria for determining reasonable charges.
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| Determining customary charges.
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| Determining prevailing charges.
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| Determination of locality.
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| Charges higher than customary or prevailing charges or lowest charge levels.
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| Illustrations of the application of the criteria for determining reasonable charges.
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| Determination of comparable circumstances; limitation.
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| Determining the inflation-indexed charge.
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| Reasonable charges for medical services, supplies, and equipment.
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| Carriers' procedural terminology and coding systems.
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| Reimbursement for clinical laboratory services billed by physicians.
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| Payment for drugs and biologicals that are not paid on a cost or prospective payment basis.
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| 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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| Limitation on payment for screening mammography services.
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| Special rule for nonparticipating physicians and suppliers furnishing screening mammography services before January 1, 2002.
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Subpart F--[RESERVED]
Subpart G--RECONSIDERATIONS AND APPEALS UNDER MEDICARE PART A
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| Basis, purpose and definitions.
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| Notice of initial determination.
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| Actions which are initial determinations.
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| Actions which are not initial determinations.
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| Decisions of utilization review committees.
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| Effect of initial determination.
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| Right to reconsideration.
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| Time and place of filing request for reconsideration.
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| Extension of time to request reconsideration.
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| Withdrawal of request for reconsideration.
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| Reconsidered determination.
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| Notice of reconsidered determination.
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| Effect of a reconsidered determination.
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| Expedited appeals process.
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| Hearing; right to hearing.
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| Time and place of filing request for a hearing.
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| Departmental Appeals Board (DAB) review.
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| Review of a national coverage determination (NCD).
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| Principles for determining the amount in controversy.
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| Amount in controversy ascertained after reconsideration.
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| Dismissal of request for hearing; amount in controversy less than $100.
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| 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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| Appeal of a categorization of a device.
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Subpart H--APPEALS UNDER THE MEDICARE PART B PROGRAM
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| Part B appeals--general description.
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| Notice of initial determination.
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| Parties to the initial determination.
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| Effect of Initial Determination.
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| Request for review of initial determination.
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| Opportunity to submit evidence.
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| Notice of review determination.
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| Effect of review determination.
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| Amount in controversy for carrier hearing, ALJ hearing and judicial review.
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| Principles for determining amount in controversy.
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| Request for carrier hearing.
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| Parties to a carrier hearing.
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| Disqualification of carrier hearing officer.
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| Location of carrier hearing.
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| Notice of carrier hearing.
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| Conduct of the carrier hearing.
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| Waiver of right to appear at carrier hearing and present evidence.
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| Dismissal of request for carrier hearing.
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| Record of carrier hearing.
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| Carrier hearing officer's decision.
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| Effect of carrier hearing officer's decision.
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| Authority of the carrier hearing officer.
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| Reopening initial or review determination of the carrier, and decision of a carrier hearing officer.
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| Notice of reopening and revision.
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| Change of ruling or legal precedent.
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| Expedited appeals process.
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| Departmental Appeals Board (DAB) review.
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| Review of a national coverage determination (NCD).
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| Appointment of representative.
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| Qualifications of representatives.
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| Authority of representatives.
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| Appeals of carrier decisions that supplier standards are not met.
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| Appeal of a categorization of a device.
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Subpart I--DETERMINATIONS, REDETERMINATIONS, RECONSIDERATIONS, AND APPEALS UNDER ORIGINAL MEDICARE (PART A AND PART B)
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| Medicare initial determinations, redeterminations and appeals: General description.
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| Parties to the initial determinations, redeterminations, reconsiderations, hearings and reviews.
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| Appointed representatives.
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| Assignment of appeal rights.
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| Notice of initial determination.
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| Time frame for processing initial determinations.
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| Actions that are initial determinations.
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| Actions that are not initial determinations.
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| Initial determinations subject to the reopenings process.
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| Effect of the initial determination.
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| Right to a redetermination.
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| Time frame for filing a request for a redetermination.
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| Place and method of filing a request for a redetermination.
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| Evidence to be submitted with the redetermination request.
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| Conduct of a redetermination.
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| Time frame for making a redetermination.
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| Withdrawal or dismissal of a request for a redetermination.
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| Notice of a redetermination.
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| Effect of a redetermination.
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| Right to a reconsideration.
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| Timeframe for filing a request for a reconsideration.
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| Place and method of filing a request for a reconsideration.
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| Evidence to be submitted with the reconsideration request.
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| Conduct of a reconsideration.
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| Timeframe for making a reconsideration.
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| Withdrawal or dismissal of a request for a reconsideration.
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| Notice of a reconsideration.
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| Effect of a reconsideration.
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| Reopenings of initial determinations, redeterminations, and reconsiderations, hearings and reviews.
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| Notice of a revised determination or decision.
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| Effect of a revised determination or decision.
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| Good cause for reopening.
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| Expedited access to judicial review.
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| Hearing before an ALJ: General rule.
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| Right to ALJ review of QIC notice of dismissal.
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| Amount in controversy required to request an ALJ hearing and judicial review.
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| Parties to an ALJ hearing.
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| When CMS or its contractors may participate in an ALJ hearing.
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| When CMS or its contractors may be a party to a hearing.
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| Request for an ALJ hearing.
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| Time frames for deciding an appeal before an ALJ.
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| Submitting evidence before the ALJ hearing.
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| Time and place for a hearing before an ALJ.
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| Notice of a hearing before an ALJ.
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| Objections to the issues.
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| Disqualification of the ALJ.
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| Prehearing case review of evidence submitted to the ALJ.
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| When an ALJ may remand a case to the QIC.
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| Description of an ALJ hearing process.
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| Deciding a case without a hearing before an ALJ.
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| Prehearing and posthearing conferences.
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| The administrative record.
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| Consolidated hearing before an ALJ.
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| Notice of an ALJ decision.
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| The effect of an ALJ's decision.
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| Removal of a hearing request from an ALJ to the MAC.
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| Dismissal of a request for a hearing before an ALJ.
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| Effect of dismissal of a request for a hearing before an ALJ.
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| Applicability of national coverage determinations (NCDs).
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| Applicability of local coverage determinations and other policies not binding on the ALJ and MAC.
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| Applicability of CMS Rulings.
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| ALJ decisions involving statistical samples.
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| Medicare Appeals Council review: General.
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| Request for MAC review when ALJ issues decision or dismissal.
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| Request for MAC review when an ALJ does not issue a decision timely.
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| Where a request for review or escalation may be filed.
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| MAC actions when request for review or escalation is filed.
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| MAC reviews on its own motion.
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| Content of request for review.
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| Dismissal of request for review.
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| Effect of dismissal of request for MAC review or request for hearing.
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| Obtaining evidence from the MAC.
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| Filing briefs with the MAC.
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| What evidence may be submitted to the MAC.
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| Case remanded by the MAC.
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| Effect of the MAC's decision.
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| Request for escalation to Federal court.
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| Extension of time to file action in Federal district court.
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| Case remanded by a Federal district court.
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| MAC review of ALJ decision in a case remanded by a Federal district court.
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Subpart J--EXPEDITED DETERMINATIONS AND RECONSIDERATIONS OF PROVIDER SERVICE TERMINATIONS, AND PROCEDURES FOR INPATIENT HOSPITAL DISCHARGES
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| Notifying beneficiaries of provider service terminations.
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| Expedited determination procedures.
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| Expedited reconsiderations.
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| Expedited determinations for inpatient hospital discharges.
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| Hospital requests expedited QIO review.
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Subparts K-Q--[RESERVED]
Subpart R--PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS
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| Intermediary determination and notice of amount of program reimbursement.
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| Matters not subject to administrative and judicial review under prospective payment.
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| Parties to intermediary determination.
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| Effect of intermediary determination.
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| Intermediary hearing procedures.
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| Right to intermediary hearing; time, place, form, and content of request for intermediary hearing.
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| Failure to timely request an intermediary hearing.
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| Parties to the intermediary hearing.
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| Hearing officer or panel of hearing officers authorized to conduct intermediary hearing; disqualification of officers.
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| Conduct of intermediary hearing.
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| Prehearing discovery and other proceedings prior to the intermediary hearing.
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| Evidence at intermediary hearing.
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| Witnesses at intermediary hearing.
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| Record of intermediary hearing.
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| Authority of hearing officer(s) at intermediary hearing.
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| Intermediary hearing decision and notice.
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| Effect of intermediary hearing decision.
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| Time, place, form, and content of request for Board hearing.
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| Expediting Board proceedings.
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| Parties to Board hearing.
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| Disqualification of Board members.
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| Establishment of time and place of hearing by the Board.
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| Conduct of Board hearing.
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| Prehearing discovery and other proceedings prior to the Board hearing.
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| Evidence at Board hearing.
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| Oral argument and written allegations.
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| Administrative policy at issue.
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| Sources of Board's authority.
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| Scope of Board's decision-making authority.
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| Board hearing decision and notice.
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| Appointment of representative.
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| Authority of representative.
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| Reopening a determination or decision.
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Subparts S-T--[RESERVED]
Subpart U--CONDITIONS FOR COVERAGE OF SUPPLIERS OF END-STAGE RENAL DISEASE (ESRD) SERVICES
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| Objectives of the end-stage renal disease (ESRD) program.
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| Designation of ESRD networks.
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| ESRD network organizations.
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| Minimum utilization rates: general.
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| Basis for determining minimum utilization rates.
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| Types and duration of classification according to utilization rates.
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| Reporting of utilization rates for classification.
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| Calculation of utilization rates for comparison with minimal utilization rate(s) and notification of status.
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| Condition: Minimum utilization rates.
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| Condition: Provider status: Renal transplantation center or renal dialysis center.
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| Condition: Furnishing data and information for ESRD program administration.
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| Condition: Participation in network activities.
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| Condition: Compliance with Federal, State and local laws and regulations.
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| Condition: Governing body and management.
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| Condition: Patient long-term program and patient care plan.
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| Condition: Patients' rights and responsibilities.
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| Condition: Medical records.
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| Condition: Physical environment.
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| Condition: Reuse of hemodialyzers and other dialysis supplies.
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| Condition: Affiliation agreement or arrangement.
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| Condition: Director of a renal dialysis facility or renal dialysis center.
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| Condition: Staff of a renal dialysis facility or renal dialysis center.
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| Condition: Minimal service requirements for a renal dialysis facility or renal dialysis center.
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| Conditions for coverage of special purpose renal dialysis facilities.
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| Condition: Director of a renal transplantation center.
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| Condition: Minimal service requirements for a renal transplantation center.
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| Termination of Medicare coverage.
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| Notice of sanction and appeal rights: Termination of coverage.
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| Notice of appeal rights: Alternative sanctions.
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Subparts V-W--[RESERVED]
Subpart X--RURAL HEALTH CLINIC AND FEDERALLY QUALIFIED HEALTH CENTER SERVICES
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| Content and terms of the agreement with the Secretary.
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| Terminations of agreements.
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| Application of Part B deductible and coinsurance.
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| Services and supplies incident to a physician's services.
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| Nurse practitioner and physician assistant services.
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| Services and supplies incident to nurse practitioner and physician assistant services.
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| Visiting nurse services: Determination of shortage of agencies.
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| Content and terms of the agreement.
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| Termination of agreement.
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| Conditions for reinstatement after termination by CMS.
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| Preventive primary services.
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| Clinical psychologist and clinical social worker services.
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| Services and supplies incident to clinical psychologist and clinical social worker services.
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| Applicability of general payment exclusions.
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| Payment for rural health clinic services and Federally qualified health clinic services.
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| What constitutes a visit.
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| Federally Qualified Health Centers supplemental payments.
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| Reports and maintenance of records.
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