e-CFR data is current as of February 22, 2021
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 Category B (Nonexperimental/investigational) device. |
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| Services related to a noncovered device. |
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| Payment for a Category B (Nonexperimental/investigational) device. |
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| Coverage of items and services in FDA-approved IDE studies. |
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| Medicare Coverage IDE study criteria. |
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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
General Provisions
Liability for Payments To Providers or Suppliers and Handling of Incorrect Payments
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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 and Recoupment of Payment to Providers and Suppliers and Collection and Compromise of Overpayments
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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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| Limitation on recoupment of provider and supplier overpayments. |
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Repayment of Scholarships and Loans
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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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| Cancellation of opt-out and early termination of opt-out. |
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| Application to Medicare Advantage 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—XXX
Subpart G—[RESERVED]
Subpart H—APPEALS UNDER THE MEDICARE PART B PROGRAM
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| Appeals of CMS or a CMS contractor. |
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| Impact of reversal of contractor determinations on claims processing. |
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| Reinstatement of provider or supplier billing privileges following corrective action. |
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| Effective date for DMEPOS supplier's billing privileges. |
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| Deadline for processing provider enrollment initial determinations. |
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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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Initial Determinations
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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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| Decisions of utilization review committees. |
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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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Redeterminations
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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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| Notice to the beneficiary of applicable plan's request for a redetermination. |
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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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Reconsideration
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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 following a contractor redetermination. |
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| Withdrawal or dismissal of a request for reconsideration or review of a contractor's dismissal of a request for redetermination. |
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| Reconsideration and review of a contractor's dismissal of a request for redetermination. |
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| Notice of a reconsideration. |
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| Effect of a reconsideration. |
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Reopenings
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| Reopening of initial determinations, redeterminations, reconsiderations, decisions, 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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| Expedited access to judicial review. |
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ALJ Hearings
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| Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule. |
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| Right to a review of QIC notice of dismissal. |
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| Amount in controversy required for an ALJ hearing and judicial review. |
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| Parties to the proceedings on a request for an ALJ hearing. |
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| When CMS or its contractors may participate in the proceedings on a request for 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 or a review of a QIC dismissal. |
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| Time frames for deciding an appeal of a QIC reconsideration or escalated request for a QIC reconsideration. |
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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 or attorney adjudicator. |
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| Review of evidence submitted by parties. |
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| Issues before an ALJ or attorney adjudicator. |
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| Requesting information from 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 proceedings. |
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| Notice of an ALJ or attorney adjudicator decision. |
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| The effect of an ALJ's or attorney adjudicator's decision. |
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| Removal of a hearing request from OMHA to the Council. |
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| Dismissal of a request for a hearing before an ALJ or request for review of a QIC dismissal. |
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| Effect of dismissal of a request for a hearing or request for review of QIC dismissal. |
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| Remands of requests for hearing and requests for review. |
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Applicability of Medicare Coverage Policies
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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 or attorney adjudicator and Council. |
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| Applicability of laws, regulations, CMS Rulings, and precedential decisions. |
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Medicare Appeals Council Review
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| Medicare Appeals Council review: General. |
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| Request for Council review when ALJ or attorney adjudicator issues decision or dismissal. |
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| Where a request for review or escalation may be filed. |
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| Council actions when request for review or escalation is filed. |
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| Council 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 Council review or request for hearing. |
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| Obtaining evidence from the Council. |
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| Filing briefs with the Council. |
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| What evidence may be submitted to the Council. |
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| Case remanded by the Council. |
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| Effect of the Council'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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| Council 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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| Notifying beneficiaries of hospital discharge appeal rights. |
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| Expedited determination procedures for inpatient hospital care. |
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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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| Contractor 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 contractor determination. |
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| Effect of contractor determination. |
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| Contractor hearing procedures. |
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| Right to contractor hearing; contents of, and adding issues to, hearing request. |
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| Good cause extension of time limit for requesting a contractor hearing. |
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| Contractor hearing officer jurisdiction. |
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| Parties to proceedings before the contractor hearing officer(s). |
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| Hearing officer or panel of hearing officers authorized to conduct contractor hearing; disqualification of officers. |
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| Conduct of contractor hearing. |
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| Prehearing discovery and other proceedings prior to the contractor hearing. |
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| Evidence at contractor hearing. |
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| Witnesses at contractor hearing. |
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| Record of proceedings before the contractor hearing officer(s). |
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| Scope of authority of contractor hearing officer(s). |
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| Contractor hearing decision. |
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| Contractor hearing officer review of compliance with the substantive reimbursement requirement of an appropriate cost report claim. |
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| Effect of contractor hearing decision. |
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| CMS reviewing official procedure. |
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| Right to Board hearing; contents of, and adding issues to, hearing request. |
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| Good cause extension of time limit for requesting a Board hearing. |
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| Expedited judicial review. |
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| Parties to proceedings in a Board appeal. |
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| Composition of Board; hearings, decisions, and remands. |
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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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| Board proceedings prior to any hearing; discovery. |
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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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| Record of administrative proceedings. |
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| Scope of Board's legal authority. |
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| Board actions in response to failure to follow Board rules. |
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| Scope of Board's authority in a hearing decision. |
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| Board review of compliance with the reimbursement requirement of an appropriate cost report claim. |
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| Appointment of representative. |
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| Authority of representative. |
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| Reopening a contractor determination or reviewing entity decision. |
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| Notice of reopening; effect of reopening. |
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| Effect of a revision; issue-specific nature of appeals of revised determinations and decisions. |
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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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| Designation of ESRD networks. |
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| ESRD network organizations. |
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Subparts V-W [Reserved]
Subpart X—RURAL HEALTH CLINIC AND FEDERALLY QUALIFIED HEALTH CENTER SERVICES
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| Rural health clinic basic requirements. |
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| Rural health clinic content and terms of the agreement with the Secretary. |
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| Termination of rural health clinic 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, physician assistant, and certified nurse midwife services. |
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| Incident to services and direct supervision. |
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| Visiting nurse services: Determination of shortage of agencies. |
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Federally Qualified Health Center Services
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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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Payment for Rural Health Clinic and Federally Qualified Health Center Services
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| Applicability of general payment exclusions. |
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| Payment for RHC and FQHC services. |
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| What constitutes a visit. |
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| Requirements of the FQHC PPS. |
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| FQHC supplemental payments. |
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| Reports and maintenance of records. |
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