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Section 423.1
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Definitions |
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Section 423.4
|
Cost-sharing in beneficiary education and enrollment-related costs |
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Section 423.6
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Eligibility and enrollment |
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Section 423.30
|
Enrollment process |
|
Section 423.32
|
Enrollment of low-income subsidy eligible individuals |
|
Section 423.34
|
Disenrollment process |
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Section 423.36
|
Enrollment periods |
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Section 423.38
|
Effective dates |
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Section 423.40
|
Involuntary disenrollment from Part D coverage |
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Section 423.44
|
Late enrollment penalty |
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Section 423.46
|
Information about Part D |
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Section 423.48
|
Procedures to determine and document creditable status of prescription drug coverage |
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Section 423.56
|
Definitions |
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Section 423.100
|
Definitions |
|
Section 423.100
|
Requirements related to qualified prescription drug coverage |
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Section 423.104
|
Establishment of prescription drug plan service areas |
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Section 423.112
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Access to covered Part D drugs |
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Section 423.120
|
Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies |
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Section 423.124
|
Dissemination of Part D plan information |
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Section 423.128
|
Public disclosure of pharmaceutical prices for equivalent drugs |
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Section 423.132
|
Privacy, confidentiality, and accuracy of enrollee records |
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Section 423.136
|
Scope |
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Section 423.150
|
Drug utilization management, quality assurance, and medication therapy management programs (MTMPs) |
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Section 423.153
|
Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans |
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Section 423.154
|
Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans |
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Section 423.154
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Consumer satisfaction surveys |
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Section 423.156
|
Electronic prescription drug program |
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Section 423.159
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Standards for electronic prescribing |
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Section 423.160
|
Standards for electronic prescribing |
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Section 423.160
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Quality improvement organization activities |
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Section 423.162
|
Compliance deemed on the basis of accreditation |
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Section 423.165
|
Accreditation organizations |
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Section 423.168
|
Procedures for approval of accreditation as a basis for deeming compliance |
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Section 423.171
|
Scope |
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Section 423.251
|
Definitions |
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Section 423.258
|
Submission of bids and related information |
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Section 423.265
|
Review and negotiation of bid and approval of plans submitted by potential Part D sponsors |
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Section 423.272
|
National average monthly bid amount |
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Section 423.279
|
Rules regarding premiums |
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Section 423.286
|
Collection of monthly beneficiary premium |
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Section 423.293
|
Scope |
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Section 423.301
|
Definitions and terminology |
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Section 423.308
|
General payment provisions |
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Section 423.315
|
Requirement for disclosure of information |
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Section 423.322
|
Determination of payments |
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Section 423.329
|
Risk-sharing arrangements |
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Section 423.336
|
Retroactive adjustments and reconciliations |
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Section 423.343
|
Reopening |
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Section 423.346
|
Payment appeals |
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Section 423.350
|
CMS-identified overpayments associated with payment data submitted by Part D sponsors |
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Section 423.352
|
Reporting and returning of overpayments |
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Section 423.360
|
General requirements for PDP sponsors |
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Section 423.401
|
Waiver of certain requirements to expand choice |
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Section 423.410
|
Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region |
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Section 423.415
|
Solvency standards for non-licensed entities |
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Section 423.420
|
Licensure does not substitute for or constitute certification |
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Section 423.425
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Prohibition of State imposition of premium taxes; relation to State laws |
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Section 423.440
|
Scope |
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Section 423.452
|
Definitions |
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Section 423.454
|
Application of Part D rules to certain Part D plans on and after January 1, 2006 |
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Section 423.458
|
Medicare secondary payer procedures |
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Section 423.462
|
Coordination of benefits with other providers of prescription drug coverage |
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Section 423.464
|
Timeframes for coordination of benefits and claims adjustments |
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Section 423.466
|
Scope |
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Section 423.500
|
Definitions |
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Section 423.501
|
Definitions |
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Section 423.501
|
Application requirements |
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Section 423.502
|
Evaluation and determination procedures for applications to be determined qualified to act as a sponsor |
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Section 423.503
|
General provisions |
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Section 423.504
|
Contract provisions |
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Section 423.505
|
Contract provisions |
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Section 423.505
|
Effective date and term of contract |
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Section 423.506
|
Nonrenewal of contract |
|
Section 423.507
|
Modification or termination of contract by mutual consent |
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Section 423.508
|
Termination of contract by CMS |
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Section 423.509
|
Termination of contract by the Part D sponsor |
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Section 423.510
|
Minimum enrollment requirements |
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Section 423.512
|
Validation of Part D reporting requirements |
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Section 423.514
|
Prohibition of midyear implementation of significant new regulatory requirements |
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Section 423.516
|
Prompt payment by Part D sponsors |
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Section 423.520
|
General provisions |
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Section 423.551
|
Novation agreement requirements |
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Section 423.552
|
Effect of leasing of a PDP sponsor's facilities |
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Section 423.553
|
Scope |
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Section 423.558
|
Definitions |
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Section 423.560
|
General provisions |
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Section 423.562
|
Grievance procedures |
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Section 423.564
|
Coverage determinations |
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Section 423.566
|
Standard timeframe and notice requirements for coverage determinations |
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Section 423.568
|
Expediting certain coverage determinations |
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Section 423.570
|
Timeframes and notice requirements for expedited coverage determinations |
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Section 423.572
|
Effect of a coverage determination |
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Section 423.576
|
Exceptions process |
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Section 423.578
|
Right to a redetermination |
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Section 423.580
|
Request for a standard redetermination |
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Section 423.582
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Expediting certain redeterminations |
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Section 423.584
|
Opportunity to submit evidence |
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Section 423.586
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Timeframes and responsibility for making redeterminations |
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Section 423.590
|
Reconsideration by an independent review entity (IRE) |
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Section 423.600
|
Notice of reconsideration determination by the independent review entity |
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Section 423.602
|
Effect of a reconsideration determination |
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Section 423.604
|
How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions |
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Section 423.636
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How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations |
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Section 423.638
|
Contract determinations |
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Section 423.641
|
Notice of contract determination |
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Section 423.642
|
Effect of contract determination |
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Section 423.643
|
Right to a hearing, burden of proof, standard of proof, and standards of review |
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Section 423.650
|
Request for hearing |
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Section 423.651
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Postponement of effective date of a contract determination when a request for a hearing is filed timely |
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Section 423.652
|
Designation of hearing officer |
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Section 423.653
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Disqualification of hearing officer |
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Section 423.654
|
Time and place of hearing |
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Section 423.655
|
Appointment of representatives |
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Section 423.656
|
Authority of representatives |
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Section 423.657
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Conduct of hearing |
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Section 423.658
|
Evidence |
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Section 423.659
|
Witnesses |
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Section 423.660
|
Witnesses lists and documents |
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Section 423.661
|
Prehearing and summary judgment |
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Section 423.662
|
Record of hearing |
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Section 423.663
|
Authority of hearing officer |
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Section 423.664
|
Notice and effect of hearing decision |
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Section 423.665
|
Review by the Administrator |
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Section 423.666
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Effect of Administrator's decision |
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Section 423.667
|
Reopening of a contract determination or decision of a hearing officer or the Administrator |
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Section 423.668
|
Types of intermediate sanctions and civil money penalties |
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Section 423.750
|
Basis for imposing intermediate sanctions and civil money penalties |
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Section 423.752
|
Procedures for imposing intermediate sanctions and civil money penalties |
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Section 423.756
|
Collection of civil money penalties imposed by CMS |
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Section 423.758
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Determinations regarding the amount of civil money penalties and assessment imposed by CMS |
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Section 423.760
|
Settlement of penalties |
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Section 423.762
|
Other applicable provisions |
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Section 423.764
|
Basis and scope |
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Section 423.771
|
Definitions |
|
Section 423.772
|
Requirements for eligibility |
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Section 423.773
|
Eligibility determinations, redeterminations, and applications |
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Section 423.774
|
Premium subsidy |
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Section 423.780
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Cost-sharing subsidy |
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Section 423.782
|
Administration of subsidy program |
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Section 423.800
|
Scope |
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Section 423.851
|
Definitions |
|
Section 423.855
|
Assuring access to a choice of coverage |
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Section 423.859
|
Submission and approval of bids |
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Section 423.863
|
Rules regarding premiums |
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Section 423.867
|
Contract terms and conditions |
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Section 423.871
|
Payment to fallback plans |
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Section 423.875
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Basis and scope |
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Section 423.880
|
Definitions |
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Section 423.882
|
Requirements for qualified retiree prescription drug plans |
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Section 423.884
|
Retiree drug subsidy amounts |
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Section 423.886
|
Payment methods, including provision of necessary information |
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Section 423.888
|
Appeals |
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Section 423.890
|
Change of ownership |
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Section 423.892
|
Construction |
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Section 423.894
|
Basis and scope |
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Section 423.900
|
Definitions |
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Section 423.902
|
Eligibility determinations for low-income subsidies |
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Section 423.904
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General payment provisions |
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Section 423.906
|
Treatment of territories |
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Section 423.907
|
Requirements |
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Section 423.910
|
Basis and scope |
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Section 423.1000
|
Definitions |
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Section 423.1002
|
Scope and applicability |
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Section 423.1004
|
Appeal rights |
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Section 423.1006
|
Appointment of representatives |
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Section 423.1008
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Authority of representatives |
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Section 423.1010
|
Fees for services of representatives |
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Section 423.1012
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Charge for transcripts |
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Section 423.1014
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Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal |
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Section 423.1016
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Notice and effect of initial determinations |
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Section 423.1018
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Request for hearing |
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Section 423.1020
|
Parties to the hearing |
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Section 423.1022
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Designation of hearing official |
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Section 423.1024
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Disqualification of Administrative Law Judge |
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Section 423.1026
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Prehearing conference |
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Section 423.1028
|
Notice of prehearing conference |
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Section 423.1030
|
Conduct of prehearing conference |
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Section 423.1032
|
Record, order, and effect of prehearing conference |
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Section 423.1034
|
Time and place of hearing |
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Section 423.1036
|
Change in time and place of hearing |
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Section 423.1038
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Joint hearings |
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Section 423.1040
|
Hearing on new issues |
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Section 423.1042
|
Subpoenas |
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Section 423.1044
|
Conduct of hearing |
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Section 423.1046
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Evidence |
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Section 423.1048
|
Witnesses |
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Section 423.1050
|
Oral and written summation |
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Section 423.1052
|
Record of hearing |
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Section 423.1054
|
Waiver of right to appear and present evidence |
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Section 423.1056
|
Dismissal of request for hearing |
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Section 423.1058
|
Dismissal for abandonment |
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Section 423.1060
|
Dismissal for cause |
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Section 423.1062
|
Notice and effect of dismissal and right to request review |
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Section 423.1064
|
Vacating a dismissal of request for hearing |
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Section 423.1066
|
Administrative Law Judge's decision |
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Section 423.1068
|
Removal of hearing to Departmental Appeals Board |
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Section 423.1070
|
Remand by the Administrative Law Judge |
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Section 423.1072
|
Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal |
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Section 423.1074
|
Request for Departmental Appeals Board review |
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Section 423.1076
|
Departmental Appeals Board action on request for review |
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Section 423.1078
|
Procedures before the Departmental Appeals Board on review |
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Section 423.1080
|
Evidence admissible on review |
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Section 423.1082
|
Decision or remand by the Departmental Appeals Board |
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Section 423.1084
|
Effect of Departmental Appeals Board Decision |
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Section 423.1086
|
Extension of time for seeking judicial review |
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Section 423.1088
|
Basis, timing, and authority for reopening an Administrative Law Judge or Board decision |
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Section 423.1090
|
Revision of reopened decision |
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Section 423.1092
|
Notice and effect of revised decision |
|
Section 423.1094
|
Scope |
|
Section 423.1968
|
Right to an ALJ hearing |
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Section 423.1970
|
Request for an ALJ hearing |
|
Section 423.1972
|
Medicare Appeals Council (MAC) review |
|
Section 423.1974
|
Judicial review |
|
Section 423.1976
|
Reopening determinations and decisions |
|
Section 423.1978
|
Reopenings of coverage determinations, redeterminations, reconsiderations, hearings and reviews |
|
Section 423.1980
|
Notice of a revised determination or decision |
|
Section 423.1982
|
Effect of a revised determination or decision |
|
Section 423.1984
|
Good cause for reopening |
|
Section 423.1986
|
Expedited access to judicial review |
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Section 423.1990
|
Hearing before an ALJ: general rule |
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Section 423.2000
|
Right to an ALJ hearing |
|
Section 423.2002
|
Right to ALJ review of IRE notice of dismissal |
|
Section 423.2004
|
Parties to an ALJ hearing |
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Section 423.2008
|
When CMS, the IRE, or Part D plan sponsors may participate in an ALJ hearing |
|
Section 423.2010
|
Request for an ALJ hearing |
|
Section 423.2014
|
Timeframes for deciding an Appeal before an ALJ |
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Section 423.2016
|
Submitting evidence before the ALJ hearing |
|
Section 423.2018
|
Time and place for a hearing before an ALJ |
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Section 423.2020
|
Notice of a hearing before an ALJ |
|
Section 423.2022
|
Objections to the issues |
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Section 423.2024
|
Disqualification of the ALJ |
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Section 423.2026
|
ALJ hearing procedures |
|
Section 423.2030
|
Issues before an ALJ |
|
Section 423.2032
|
When an ALJ may remand a case |
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Section 423.2034
|
Description of an ALJ hearing process |
|
Section 423.2036
|
Deciding a case without a hearing before an ALJ |
|
Section 423.2038
|
Prehearing and posthearing conferences |
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Section 423.2040
|
The administrative record |
|
Section 423.2042
|
Consolidated hearing before an ALJ |
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Section 423.2044
|
Notice of an ALJ decision |
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Section 423.2046
|
The effect of an ALJ's decision |
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Section 423.2048
|
Removal of a hearing request from an ALJ to the MAC |
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Section 423.2050
|
Dismissal of a request for a hearing before an ALJ |
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Section 423.2052
|
Effect of dismissal of a request for a hearing before an ALJ |
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Section 423.2054
|
Applicability of policies not binding on the ALJ and MAC |
|
Section 423.2062
|
Applicability of laws, regulations and CMS Rulings |
|
Section 423.2063
|
Medicare appeals council review: general |
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Section 423.2100
|
Request for MAC review when ALJ issues decision or dismissal |
|
Section 423.2102
|
Where a request for review may be filed |
|
Section 423.2106
|
MAC Actions when request for review is filed |
|
Section 423.2108
|
MAC reviews on its own motion |
|
Section 423.2110
|
Content of request for review |
|
Section 423.2112
|
Dismissal of request for review |
|
Section 423.2114
|
Effect of dismissal of request for MAC review or request for hearing |
|
Section 423.2116
|
Obtaining evidence from the MAC |
|
Section 423.2118
|
Filing briefs with the MAC |
|
Section 423.2120
|
What evidence may be submitted to the MAC |
|
Section 423.2122
|
Oral argument |
|
Section 423.2124
|
Case remanded by the MAC |
|
Section 423.2126
|
Action of the MAC |
|
Section 423.2128
|
Effect of the MAC's decision |
|
Section 423.2130
|
Extension of time to file action in Federal District Court |
|
Section 423.2134
|
Judicial review |
|
Section 423.2136
|
Case remanded by a Federal District Court |
|
Section 423.2138
|
MAC Review of ALJ decision in a case remanded by a Federal District Court |
|
Section 423.2140
|
Definitions concerning marketing materials |
|
Section 423.2260
|
Review and distribution of marketing materials |
|
Section 423.2262
|
Guidelines for CMS review |
|
Section 423.2264
|
Standards for Part D marketing |
|
Section 423.2268
|
Licensing of marketing representatives and confirmation of marketing resources |
|
Section 423.2272
|
Broker and agent requirements |
|
Section 423.2274
|
Employer group retiree marketing |
|
Section 423.2276
|
Scope |
|
Section 423.2300
|
Definitions |
|
Section 423.2305
|
Condition for coverage of drugs under Part D |
|
Section 423.2310
|
Medicare Coverage Gap Discount Program Agreement |
|
Section 423.2315
|
Payment processes for Part D sponsors |
|
Section 423.2320
|
Provision of applicable discounts |
|
Section 423.2325
|
Manufacturer discount payment audit and dispute resolution |
|
Section 423.2330
|
Beneficiary dispute resolution |
|
Section 423.2335
|
Compliance monitoring and civil money penalties |
|
Section 423.2340
|
Termination of Discount Program Agreement |
|
Section 423.2345
|
Basis and scope |
|
Section 423.2400
|
Definitions |
|
Section 423.2401
|
General requirements |
|
Section 423.2410
|
Calculation of medical loss ratio |
|
Section 423.2420
|
Activities that improve health care quality |
|
Section 423.2430
|
Credibility adjustment |
|
Section 423.2440
|
Reporting requirements |
|
Section 423.2460
|
Remittance to CMS if the applicable MLR requirement is not met |
|
Section 423.2470
|
MLR review and non-compliance |
|
Section 423.2480
|
Payment appeals |
|
Section 423.2600
|
Request for reconsideration |
|
Section 423.2605
|
Hearing official review |
|
Section 423.2610
|
Review by the Administrator |
|
Section 423.2615
|
Basis and scope |