e-CFR data is current as of July 6, 2020
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
|
| Scope of subpart and definitions. |
|
|
| FDA categorization of investigational devices. |
|
|
| Coverage of a Category B (Nonexperimental/investigational) device. |
|
|
| Services related to a noncovered device. |
|
|
| Payment for a Category B (Nonexperimental/investigational) device. |
|
|
| Coverage of items and services in FDA-approved IDE studies. |
|
|
| Medicare Coverage IDE study criteria. |
|
|
| Re-evaluation of a device categorization. |
|
|
| Confidential commercial and trade secret information. |
|
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
|
| Individual's liability for payments made to providers and other persons for items and services furnished the individual. |
|
|
| Incorrect payments for which the individual is not liable. |
|
|
| Adjustment of title XVIII incorrect payments. |
|
|
| Certification of amount that will be adjusted against individual title II or railroad retirement benefits. |
|
|
| Procedures for adjustment or recovery—title II beneficiary. |
|
|
| Waiver of adjustment or recovery. |
|
|
| Principles applied in waiver of adjustment or recovery. |
|
|
| Notice of right to waiver consideration. |
|
|
| When waiver of adjustment or recovery may be applied. |
|
|
| Liability of certifying or disbursing officer. |
|
Suspension and Recoupment of Payment to Providers and Suppliers and Collection and Compromise of Overpayments
|
| Suspension, offset, and recoupment of Medicare payments to providers and suppliers of services. |
|
|
| Proceeding for suspension of payment. |
|
|
| Proceeding for offset or recoupment. |
|
|
| Opportunity for rebuttal. |
|
|
| Time limits for, and notification of, administrative determination after receipt of rebuttal statement. |
|
|
| Suspension and termination of collection action and compromise of claims for overpayment. |
|
|
| Withholding Medicare payments to recover Medicaid overpayments. |
|
|
| Interest charges on overpayment and underpayments to providers, suppliers, and other entities. |
|
|
| Limitation on recoupment of provider and supplier overpayments. |
|
Repayment of Scholarships and Loans
|
| Collection of past-due amounts on scholarship and loan programs. |
|
Subpart D—PRIVATE CONTRACTS
|
| Conditions for properly opting-out of Medicare. |
|
|
| Requirements of the private contract. |
|
|
| Requirements of the opt-out affidavit. |
|
|
| Effects of opting-out of Medicare. |
|
|
| Failure to properly opt-out. |
|
|
| Failure to maintain opt-out. |
|
|
| Emergency and urgent care services. |
|
|
| Cancellation of opt-out and early termination of opt-out. |
|
|
| Application to Medicare Advantage contracts. |
|
Subpart E—CRITERIA FOR DETERMINING REASONABLE CHARGES
|
| Determination of reasonable charges. |
|
|
| Criteria for determining reasonable charges. |
|
|
| Determining customary charges. |
|
|
| Determining prevailing charges. |
|
|
| Determination of locality. |
|
|
| Charges higher than customary or prevailing charges or lowest charge levels. |
|
|
| Illustrations of the application of the criteria for determining reasonable charges. |
|
|
| Determination of comparable circumstances; limitation. |
|
|
| Determining the inflation-indexed charge. |
|
|
| Reasonable charges for medical services, supplies, and equipment. |
|
|
| Carriers' procedural terminology and coding systems. |
|
|
| Reimbursement for clinical laboratory services billed by physicians. |
|
|
| Payment for drugs and biologicals that are not paid on a cost or prospective payment basis. |
|
|
| Payment for a physician assistant's, nurse practitioner's, and clinical nurse specialists' services and services furnished incident to their professional services. |
|
|
| Limitation on payment for screening mammography services. |
|
|
| Special rule for nonparticipating physicians and suppliers furnishing screening mammography services before January 1, 2002. |
|
Subparts F-G [Reserved]
Subpart H—APPEALS UNDER THE MEDICARE PART B PROGRAM
|
| Appeals of CMS or a CMS contractor. |
|
|
| Impact of reversal of contractor determinations on claims processing. |
|
|
| Reinstatement of provider or supplier billing privileges following corrective action. |
|
|
| Effective date for DMEPOS supplier's billing privileges. |
|
|
| Deadline for processing provider enrollment initial determinations. |
|
Subpart I—DETERMINATIONS, REDETERMINATIONS, RECONSIDERATIONS, AND APPEALS UNDER ORIGINAL MEDICARE (PART A AND PART B)
|
| Medicare initial determinations, redeterminations and appeals: General description. |
|
|
| Parties to the initial determinations, redeterminations, reconsiderations, hearings, and reviews. |
|
|
| Appointed representatives. |
|
|
| Assignment of appeal rights. |
|
Initial Determinations
|
| Notice of initial determination. |
|
|
| Time frame for processing initial determinations. |
|
|
| Actions that are initial determinations. |
|
|
| Decisions of utilization review committees. |
|
|
| Actions that are not initial determinations. |
|
|
| Initial determinations subject to the reopenings process. |
|
|
| Effect of the initial determination. |
|
Redeterminations
|
| Right to a redetermination. |
|
|
| Time frame for filing a request for a redetermination. |
|
|
| Place and method of filing a request for a redetermination. |
|
|
| Evidence to be submitted with the redetermination request. |
|
|
| Notice to the beneficiary of applicable plan's request for a redetermination. |
|
|
| Conduct of a redetermination. |
|
|
| Time frame for making a redetermination. |
|
|
| Withdrawal or dismissal of a request for a redetermination. |
|
|
| Notice of a redetermination. |
|
|
| Effect of a redetermination. |
|
Reconsideration
|
| Right to a reconsideration. |
|
|
| Timeframe for filing a request for a reconsideration. |
|
|
| Place and method of filing a request for a reconsideration. |
|
|
| Evidence to be submitted with the reconsideration request. |
|
|
| Conduct of a reconsideration. |
|
|
| Timeframe for making a reconsideration following a contractor redetermination. |
|
|
| Withdrawal or dismissal of a request for reconsideration or review of a contractor's dismissal of a request for redetermination. |
|
|
| Reconsideration and review of a contractor's dismissal of a request for redetermination. |
|
|
| Notice of a reconsideration. |
|
|
| Effect of a reconsideration. |
|
Reopenings
|
| Reopening of initial determinations, redeterminations, reconsiderations, decisions, and reviews. |
|
|
| Notice of a revised determination or decision. |
|
|
| Effect of a revised determination or decision. |
|
|
| Good cause for reopening. |
|
Expedited Access to Judicial Review
|
| Expedited access to judicial review. |
|
ALJ Hearings
|
| Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule. |
|
|
| Right to a review of QIC notice of dismissal. |
|
|
| Amount in controversy required for an ALJ hearing and judicial review. |
|
|
| Parties to the proceedings on a request for an ALJ hearing. |
|
|
| When CMS or its contractors may participate in the proceedings on a request for an ALJ hearing. |
|
|
| When CMS or its contractors may be a party to a hearing. |
|
|
| Request for an ALJ hearing or a review of a QIC dismissal. |
|
|
| Time frames for deciding an appeal of a QIC reconsideration or escalated request for a QIC reconsideration. |
|
|
| Time and place for a hearing before an ALJ. |
|
|
| Notice of a hearing before an ALJ. |
|
|
| Objections to the issues. |
|
|
| Disqualification of the ALJ or attorney adjudicator. |
|
|
| Review of evidence submitted by parties. |
|
|
| Issues before an ALJ or attorney adjudicator. |
|
|
| Requesting information from the QIC. |
|
|
| Description of an ALJ hearing process. |
|
|
| Deciding a case without a hearing before an ALJ. |
|
|
| Prehearing and posthearing conferences. |
|
|
| The administrative record. |
|
|
| Consolidated proceedings. |
|
|
| Notice of an ALJ or attorney adjudicator decision. |
|
|
| The effect of an ALJ's or attorney adjudicator's decision. |
|
|
| Removal of a hearing request from OMHA to the Council. |
|
|
| Dismissal of a request for a hearing before an ALJ or request for review of a QIC dismissal. |
|
|
| Effect of dismissal of a request for a hearing or request for review of QIC dismissal. |
|
|
| Remands of requests for hearing and requests for review. |
|
Applicability of Medicare Coverage Policies
|
| Applicability of national coverage determinations (NCDs). |
|
|
| Applicability of local coverage determinations and other policies not binding on the ALJ or attorney adjudicator and Council. |
|
|
| Applicability of laws, regulations, CMS Rulings, and precedential decisions. |
|
Medicare Appeals Council Review
|
| Medicare Appeals Council review: General. |
|
|
| Request for Council review when ALJ or attorney adjudicator issues decision or dismissal. |
|
|
| Where a request for review or escalation may be filed. |
|
|
| Council actions when request for review or escalation is filed. |
|
|
| Council reviews on its own motion. |
|
|
| Content of request for review. |
|
|
| Dismissal of request for review. |
|
|
| Effect of dismissal of request for Council review or request for hearing. |
|
|
| Obtaining evidence from the Council. |
|
|
| Filing briefs with the Council. |
|
|
| What evidence may be submitted to the Council. |
|
|
| Case remanded by the Council. |
|
|
| Effect of the Council's decision. |
|
|
| Request for escalation to Federal court. |
|
|
| Extension of time to file action in Federal district court. |
|
|
| Case remanded by a Federal district court. |
|
|
| Council review of ALJ decision in a case remanded by a Federal district court. |
|
Subpart J—EXPEDITED DETERMINATIONS AND RECONSIDERATIONS OF PROVIDER SERVICE TERMINATIONS, AND PROCEDURES FOR INPATIENT HOSPITAL DISCHARGES
|
| Notifying beneficiaries of provider service terminations. |
|
|
| Expedited determination procedures. |
|
|
| Expedited reconsiderations. |
|
|
| Notifying beneficiaries of hospital discharge appeal rights. |
|
|
| Expedited determination procedures for inpatient hospital care. |
|
|
| Hospital requests expedited QIO review. |
|
Subparts K-Q [Reserved]
Subpart R—PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS
|
| Contractor determination and notice of amount of program reimbursement. |
|
|
| Matters not subject to administrative and judicial review under prospective payment. |
|
|
| Parties to contractor determination. |
|
|
| Effect of contractor determination. |
|
|
| Contractor hearing procedures. |
|
|
| Right to contractor hearing; contents of, and adding issues to, hearing request. |
|
|
| Good cause extension of time limit for requesting a contractor hearing. |
|
|
| Contractor hearing officer jurisdiction. |
|
|
| Parties to proceedings before the contractor hearing officer(s). |
|
|
| Hearing officer or panel of hearing officers authorized to conduct contractor hearing; disqualification of officers. |
|
|
| Conduct of contractor hearing. |
|
|
| Prehearing discovery and other proceedings prior to the contractor hearing. |
|
|
| Evidence at contractor hearing. |
|
|
| Witnesses at contractor hearing. |
|
|
| Record of proceedings before the contractor hearing officer(s). |
|
|
| Scope of authority of contractor hearing officer(s). |
|
|
| Contractor hearing decision. |
|
|
| Contractor hearing officer review of compliance with the substantive reimbursement requirement of an appropriate cost report claim. |
|
|
| Effect of contractor hearing decision. |
|
|
| CMS reviewing official procedure. |
|
|
| Right to Board hearing; contents of, and adding issues to, hearing request. |
|
|
| Good cause extension of time limit for requesting a Board hearing. |
|
|
| Expedited judicial review. |
|
|
| Parties to proceedings in a Board appeal. |
|
|
| Composition of Board; hearings, decisions, and remands. |
|
|
| Disqualification of Board members. |
|
|
| Establishment of time and place of hearing by the Board. |
|
|
| Conduct of Board hearing. |
|
|
| Board proceedings prior to any hearing; discovery. |
|
|
| Evidence at Board hearing. |
|
|
| Oral argument and written allegations. |
|
|
| Administrative policy at issue. |
|
|
| Record of administrative proceedings. |
|
|
| Scope of Board's legal authority. |
|
|
| Board actions in response to failure to follow Board rules. |
|
|
| Scope of Board's authority in a hearing decision. |
|
|
| Board review of compliance with the reimbursement requirement of an appropriate cost report claim. |
|
|
| Appointment of representative. |
|
|
| Authority of representative. |
|
|
| Reopening a contractor determination or reviewing entity decision. |
|
|
| Notice of reopening; effect of reopening. |
|
|
| Effect of a revision; issue-specific nature of appeals of revised determinations and decisions. |
|
Subparts S-T [Reserved]
Subpart U—CONDITIONS FOR COVERAGE OF SUPPLIERS OF END-STAGE RENAL DISEASE (ESRD) SERVICES
|
| Designation of ESRD networks. |
|
|
| ESRD network organizations. |
|
Subparts V-W [Reserved]
Subpart X—RURAL HEALTH CLINIC AND FEDERALLY QUALIFIED HEALTH CENTER SERVICES
|
| Rural health clinic basic requirements. |
|
|
| Rural health clinic content and terms of the agreement with the Secretary. |
|
|
| Termination of rural health clinic agreements. |
|
|
| Application of Part B deductible and coinsurance. |
|
|
| Services and supplies incident to a physician's services. |
|
|
| Nurse practitioner, physician assistant, and certified nurse midwife services. |
|
|
| Incident to services and direct supervision. |
|
|
| Visiting nurse services: Determination of shortage of agencies. |
|
Federally Qualified Health Center Services
|
| Content and terms of the agreement. |
|
|
| Termination of agreement. |
|
|
| Conditions for reinstatement after termination by CMS. |
|
|
| Preventive primary services. |
|
|
| Clinical psychologist and clinical social worker services. |
|
|
| Services and supplies incident to clinical psychologist and clinical social worker services. |
|
Payment for Rural Health Clinic and Federally Qualified Health Center Services
|
| Applicability of general payment exclusions. |
|
|
| Payment for RHC and FQHC services. |
|
|
| What constitutes a visit. |
|
|
| Requirements of the FQHC PPS. |
|
|
| FQHC supplemental payments. |
|
|
| Reports and maintenance of records. |
|
|
