Title 42, Part 405 — Federal Health Insurance for the Aged and Disabled

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.

Scope of subpart.

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.

Definitions.

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.

Collection of past-due amounts on scholarship and loan programs.

Definitions.

General rules.

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.

Appeals.

Application to Medicare Advantage contracts.

Basis.

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.

Appeals of CMS or a CMS contractor.

Appeals rights.

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.

Submission of claims.

Deadline for processing provider enrollment initial determinations.

Basis and scope.

Definitions.

Prepayment review.

Medicare initial determinations, redeterminations and appeals: General description.

Parties to the initial determinations, redeterminations, reconsiderations, hearings, and reviews.

Medicaid State agencies.

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.

Post-payment review.

Failure to respond to additional documentation request.

Scope, basis, and definitions.

Right to appeal a denial of Part A coverage resulting from a change in patient status.

Reconsideration.

Hearings before an ALJ and decisions by an ALJ or Attorney Adjudicator.

Review by the Medicare Appeals Council and judicial review.

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.

Redetermination.

Notice of a redetermination.

Effect of a redetermination.

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.

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.

Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule.

Right to an ALJ hearing.

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.

Submitting evidence.

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.

ALJ hearing procedures.

Issues before an ALJ or attorney adjudicator.

Requesting information from the QIC.

Description of an ALJ hearing process.

Discovery.

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.

Effect of a remand.

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: 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.

Oral argument.

Case remanded by the Council.

Action of the Council.

Effect of the Council's decision.

Request for escalation to Federal court.

Extension of time to file action in Federal district court.

Judicial review.

Case remanded by a Federal district court.

Council review of ALJ decision in a case remanded by a Federal district court.

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.

Notifying eligible beneficiaries of appeal rights when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.

Expedited determination procedures when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.

Expedited reconsideration procedures regarding Part A coverage when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.

Introduction.

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.

Group appeals.

Amount in controversy.

Board jurisdiction.

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.

Subpoenas.

Witnesses.

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 hearing decision.

Board review of compliance with the reimbursement requirement of an appropriate cost report claim.

Administrator review.

Judicial review.

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.

§§ 405.2100-405.2101 [Reserved]

Definitions.

Designation of ESRD networks.

[Reserved]

ESRD network organizations.

Medical review board.

[Reserved]

§§ 405.2131-405.2184 [Reserved]

Basis.

Scope and definitions.

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.

Scope of benefits.

Physicians' services.

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.

Visiting nurse services: Determination of shortage of agencies.

Basic requirements.

Content and terms of the agreement.

Termination of agreement.

Conditions for reinstatement after termination by CMS.

Notice to the public.

Change of ownership.

Scope of services.

Preventive primary services.

Preventive services.

Clinical psychologist, clinical social worker, marriage and family therapist, and mental health counselor services.

Services and supplies incident to clinical psychologist, clinical social worker, marriage and family therapist, and mental health counselor services.

Applicability of general payment exclusions.

Payment for RHC and FQHC services.

What constitutes a visit.

Payment rate.

Annual reconciliation.

Requirements of the FQHC PPS.

Allowable costs.

FQHC supplemental payments.

Reports and maintenance of records.

Beneficiary appeals.