About GPO   |   Newsroom/Media   |   Congressional Relations   |   Inspector General   |   Careers   |   Contact   |   askGPO   |   Help  
 
Home   |   Customers   |   Vendors   |   Libraries  

The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.

[1]
 
 

Electronic Code of Federal Regulations

blue pill

e-CFR Data is current as of October 29, 2014

Title 42Chapter IVSubchapter BPart 423


TITLE 42—Public Health

CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER B—MEDICARE PROGRAM (CONTINUED)

PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

rule

Subpart A—GENERAL PROVISIONS

§423.1
Basis and scope.
§423.4
Definitions.
§423.6
Cost-sharing in beneficiary education and enrollment-related costs.
rule

Subpart B—ELIGIBILITY AND ENROLLMENT

§423.30
Eligibility and enrollment.
§423.32
Enrollment process.
§423.34
Enrollment of low-income subsidy eligible individuals.
§423.36
Disenrollment process.
§423.38
Enrollment periods.
§423.40
Effective dates.
§423.44
Involuntary disenrollment from Part D coverage.
§423.46
Late enrollment penalty.
§423.48
Information about Part D.
§423.56
Procedures to determine and document creditable status of prescription drug coverage.
rule

Subpart C—BENEFITS AND BENEFICIARY PROTECTIONS

§423.100
Definitions.
§423.104
Requirements related to qualified prescription drug coverage.
§423.112
Establishment of prescription drug plan service areas.
§423.120
Access to covered Part D drugs.
§423.124
Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.
§423.128
Dissemination of Part D plan information.
§423.132
Public disclosure of pharmaceutical prices for equivalent drugs.
§423.136
Privacy, confidentiality, and accuracy of enrollee records.
rule

Subpart D—COST CONTROL AND QUALITY IMPROVEMENT REQUIREMENTS

§423.150
Scope.
§423.153
Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).
§423.154
Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans.
§423.156
Consumer satisfaction surveys.
§423.159
Electronic prescription drug program.
§423.160
Standards for electronic prescribing.
§423.162
Quality improvement organization activities.
§423.165
Compliance deemed on the basis of accreditation.
§423.168
Accreditation organizations.
§423.171
Procedures for approval of accreditation as a basis for deeming compliance.
rule

Subpart E—[RESERVED]

rule

Subpart F—SUBMISSION OF BIDS AND MONTHLY BENEFICIARY PREMIUMS; PLAN APPROVAL

§423.251
Scope.
§423.258
Definitions.
§423.265
Submission of bids and related information.
§423.272
Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.
§423.279
National average monthly bid amount.
§423.286
Rules regarding premiums.
§423.293
Collection of monthly beneficiary premium.
rule

Subpart G—PAYMENTS TO PART D PLAN SPONSORS FOR QUALIFIED PRESCRIPTION DRUG COVERAGE

§423.301
Scope.
§423.308
Definitions and terminology.
§423.315
General payment provisions.
§423.322
Requirement for disclosure of information.
§423.329
Determination of payments.
§423.336
Risk-sharing arrangements.
§423.343
Retroactive adjustments and reconciliations.
§423.346
Reopening.
§423.350
Payment appeals.
§423.360
Reporting and returning of overpayments.
rule

Subpart H—[RESERVED]

rule

Subpart I—ORGANIZATION COMPLIANCE WITH STATE LAW AND PREEMPTION BY FEDERAL LAW

§423.401
General requirements for PDP sponsors.
§423.410
Waiver of certain requirements to expand choice.
§423.415
Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region
§423.420
Solvency standards for non-licensed entities.
§423.425
Licensure does not substitute for or constitute certification.
§423.440
Prohibition of State imposition of premium taxes; relation to State laws.
rule

Subpart J—COORDINATION OF PART D PLANS WITH OTHER PRESCRIPTION DRUG COVERAGE

§423.452
Scope.
§423.454
Definitions.
§423.458
Application of Part D rules to certain Part D plans on and after January 1, 2006.
§423.462
Medicare secondary payer procedures.
§423.464
Coordination of benefits with other providers of prescription drug coverage.
§423.466
Timeframes for coordination of benefits.
rule

Subpart K—APPLICATION PROCEDURES AND CONTRACTS WITH PART D PLAN SPONSORS

§423.500
Scope.
§423.501
Definitions
§423.502
Application requirements.
§423.503
Evaluation and determination procedures for applications to be determined qualified to act as a sponsor.
§423.504
General provisions.
§423.505
Contract provisions.
§423.506
Effective date and term of contract.
§423.507
Nonrenewal of contract.
§423.508
Modification or termination of contract by mutual consent.
§423.509
Termination of contract by CMS.
§423.510
Termination of contract by the Part D sponsor.
§423.512
Minimum enrollment requirements.
§423.514
Validation of Part D reporting requirements.
§423.516
Prohibition of midyear implementation of significant new regulatory requirements.
§423.520
Prompt payment by Part D sponsors.
rule

Subpart L—EFFECT OF CHANGE OF OWNERSHIP OR LEASING OF FACILITIES DURING TERM OF CONTRACT

§423.551
General provisions.
§423.552
Novation agreement requirements.
§423.553
Effect of leasing of a PDP sponsor's facilities.
rule

Subpart M—GRIEVANCES, COVERAGE DETERMINATIONS, REDETERMINATIONS, AND RECONSIDERATIONS

§423.558
Scope.
§423.560
Definitions.
§423.562
General provisions.
§423.564
Grievance procedures.
§423.566
Coverage determinations.
§423.568
Standard timeframe and notice requirements for coverage determinations.
§423.570
Expediting certain coverage determinations.
§423.572
Timeframes and notice requirements for expedited coverage determinations.
§423.576
Effect of a coverage determination.
§423.578
Exceptions process.
§423.580
Right to a redetermination.
§423.582
Request for a standard redetermination.
§423.584
Expediting certain redeterminations.
§423.586
Opportunity to submit evidence.
§423.590
Timeframes and responsibility for making redeterminations.
§423.600
Reconsideration by an independent review entity (IRE).
§423.602
Notice of reconsideration determination by the independent review entity.
§423.604
Effect of a reconsideration determination.
§§423.610-423.634
[Reserved]
§423.636
How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions.
§423.638
How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations.
rule

Subpart N—MEDICARE CONTRACT DETERMINATIONS AND APPEALS

§423.641
Contract determinations.
§423.642
Notice of contract determination.
§423.643
Effect of contract determination.
§423.650
Right to a hearing, burden of proof, standard of proof, and standards of review.
§423.651
Request for hearing.
§423.652
Postponement of effective date of a contract determination when a request for a hearing is filed timely.
§423.653
Designation of hearing officer.
§423.654
Disqualification of hearing officer.
§423.655
Time and place of hearing.
§423.656
Appointment of representatives.
§423.657
Authority of representatives.
§423.658
Conduct of hearing.
§423.659
Evidence.
§423.660
Witnesses.
§423.661
Witnesses lists and documents.
§423.662
Prehearing and summary judgment.
§423.663
Record of hearing.
§423.664
Authority of hearing officer.
§423.665
Notice and effect of hearing decision.
§423.666
Review by the Administrator.
§423.667
Effect of Administrator's decision.
§423.668
Reopening of a contract determination or decision of a hearing officer or the Administrator.
rule

Subpart O—INTERMEDIATE SANCTIONS

§423.750
Types of intermediate sanctions and civil money penalties.
§423.752
Basis for imposing intermediate sanctions and civil money penalties.
§423.756
Procedures for imposing intermediate sanctions and civil money penalties.
§423.758
Collection of civil money penalties imposed by CMS.
§423.760
Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
§423.762
Settlement of penalties.
§423.764
Other applicable provisions.
rule

Subpart P—PREMIUMS AND COST-SHARING SUBSIDIES FOR LOW-INCOME INDIVIDUALS

§423.771
Basis and scope.
§423.772
Definitions.
§423.773
Requirements for eligibility.
§423.774
Eligibility determinations, redeterminations, and applications.
§423.780
Premium subsidy.
§423.782
Cost-sharing subsidy.
§423.800
Administration of subsidy program.
rule

Subpart Q—GUARANTEEING ACCESS TO A CHOICE OF COVERAGE (FALLBACK PRESCRIPTION DRUG PLANS)

§423.851
Scope.
§423.855
Definitions.
§423.859
Assuring access to a choice of coverage.
§423.863
Submission and approval of bids.
§423.867
Rules regarding premiums.
§423.871
Contract terms and conditions.
§423.875
Payment to fallback plans.
rule

Subpart R—PAYMENTS TO SPONSORS OF RETIREE PRESCRIPTION DRUG PLANS

§423.880
Basis and scope.
§423.882
Definitions.
§423.884
Requirements for qualified retiree prescription drug plans.
§423.886
Retiree drug subsidy amounts.
§423.888
Payment methods, including provision of necessary information.
§423.890
Appeals.
§423.892
Change of ownership.
§423.894
Construction.
rule

Subpart S—SPECIAL RULES FOR STATES-ELIGIBILITY DETERMINATIONS FOR SUBSIDIES AND GENERAL PAYMENT PROVISIONS

§423.900
Basis and scope.
§423.902
Definitions.
§423.904
Eligibility determinations for low-income subsidies.
§423.906
General payment provisions.
§423.907
Treatment of territories.
§423.908.
Phased-down State contribution to drug benefit costs assumed by Medicare.
§423.910
Requirements.
rule

Subpart T—APPEAL PROCEDURES FOR CIVIL MONEY PENALTIES

§423.1000
Basis and scope.
§423.1002
Definitions.
§423.1004
Scope and applicability.
§423.1006
Appeal rights.
§423.1008
Appointment of representatives.
§423.1010
Authority of representatives.
§423.1012
Fees for services of representatives.
§423.1014
Charge for transcripts.
§423.1016
Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal.
§423.1018
Notice and effect of initial determinations.
§423.1020
Request for hearing.
§423.1022
Parties to the hearing.
§423.1024
Designation of hearing official.
§423.1026
Disqualification of Administrative Law Judge.
§423.1028
Prehearing conference.
§423.1030
Notice of prehearing conference.
§423.1032
Conduct of prehearing conference.
§423.1034
Record, order, and effect of prehearing conference.
§423.1036
Time and place of hearing.
§423.1038
Change in time and place of hearing.
§423.1040
Joint hearings.
§423.1042
Hearing on new issues.
§423.1044
Subpoenas.
§423.1046
Conduct of hearing.
§423.1048
Evidence.
§423.1050
Witnesses.
§423.1052
Oral and written summation.
§423.1054
Record of hearing.
§423.1056
Waiver of right to appear and present evidence.
§423.1058
Dismissal of request for hearing.
§423.1060
Dismissal for abandonment.
§423.1062
Dismissal for cause.
§423.1064
Notice and effect of dismissal and right to request review.
§423.1066
Vacating a dismissal of request for hearing.
§423.1068
Administrative Law Judge's decision.
§423.1070
Removal of hearing to Departmental Appeals Board.
§423.1072
Remand by the Administrative Law Judge.
§423.1074
Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.
§423.1076
Request for Departmental Appeals Board review.
§423.1078
Departmental Appeals Board action on request for review.
§423.1080
Procedures before the Departmental Appeals Board on review.
§423.1082
Evidence admissible on review.
§423.1084
Decision or remand by the Departmental Appeals Board.
§423.1086
Effect of Departmental Appeals Board Decision.
§423.1088
Extension of time for seeking judicial review.
§423.1090
Basis, timing, and authority for reopening an Administrative Law Judge or Board decision.
§423.1092
Revision of reopened decision.
§423.1094
Notice and effect of revised decision.
rule

Subpart U—REOPENING, ALJ HEARINGS, MAC REVIEW, AND JUDICIAL REVIEW

§423.1968
Scope.
§423.1970
Right to an ALJ hearing.
§423.1972
Request for an ALJ hearing.
§423.1974
Medicare Appeals Council (MAC) review.
§423.1976
Judicial review.
§423.1978
Reopening determinations and decisions.
§423.1980
Reopenings of coverage determinations, redeterminations, reconsiderations, hearings and reviews.
§423.1982
Notice of a revised determination or decision.
§423.1984
Effect of a revised determination or decision.
§423.1986
Good cause for reopening.
§423.1990
Expedited access to judicial review.
§423.2000
Hearing before an ALJ: general rule.
§423.2002
Right to an ALJ hearing.
§423.2004
Right to ALJ review of IRE notice of dismissal.
§423.2008
Parties to an ALJ hearing.
§423.2010
When CMS, the IRE, or Part D plan sponsors may participate in an ALJ hearing.
§423.2014
Request for an ALJ hearing.
§423.2016
Timeframes for deciding an Appeal before an ALJ.
§423.2018
Submitting evidence before the ALJ hearing.
§423.2020
Time and place for a hearing before an ALJ.
§423.2022
Notice of a hearing before an ALJ.
§423.2024
Objections to the issues.
§423.2026
Disqualification of the ALJ.
§423.2030
ALJ hearing procedures.
§423.2032
Issues before an ALJ.
§423.2034
When an ALJ may remand a case.
§423.2036
Description of an ALJ hearing process.
§423.2038
Deciding a case without a hearing before an ALJ.
§423.2040
Prehearing and posthearing conferences.
§423.2042
The administrative record.
§423.2044
Consolidated hearing before an ALJ.
§423.2046
Notice of an ALJ decision.
§423.2048
The effect of an ALJ's decision.
§423.2050
Removal of a hearing request from an ALJ to the MAC.
§423.2052
Dismissal of a request for a hearing before an ALJ.
§423.2054
Effect of dismissal of a request for a hearing before an ALJ.
§423.2062
Applicability of policies not binding on the ALJ and MAC.
§423.2063
Applicability of laws, regulations and CMS Rulings.
§423.2100
Medicare appeals council review: general.
§423.2102
Request for MAC review when ALJ issues decision or dismissal.
§423.2106
Where a request for review may be filed.
§423.2108
MAC Actions when request for review is filed.
§423.2110
MAC reviews on its own motion.
§423.2112
Content of request for review.
§423.2114
Dismissal of request for review.
§423.2116
Effect of dismissal of request for MAC review or request for hearing.
§423.2118
Obtaining evidence from the MAC.
§423.2120
Filing briefs with the MAC.
§423.2122
What evidence may be submitted to the MAC.
§423.2124
Oral argument.
§423.2126
Case remanded by the MAC.
§423.2128
Action of the MAC.
§423.2130
Effect of the MAC's decision.
§423.2134
Extension of time to file action in Federal District Court.
§423.2136
Judicial review.
§423.2138
Case remanded by a Federal District Court.
§423.2140
MAC Review of ALJ decision in a case remanded by a Federal District Court.
rule

Subpart V—PART D MARKETING REQUIREMENTS

§423.2260
Definitions concerning marketing materials.
§423.2262
Review and distribution of marketing materials.
§423.2264
Guidelines for CMS review.
§423.2266
Deemed approval.
§423.2268
Standards for Part D marketing.
§423.2272
Licensing of marketing representatives and confirmation of marketing resources.
§423.2274
Broker and agent requirements.
§423.2276
Employer group retiree marketing.
rule

Subpart W—MEDICARE COVERAGE GAP DISCOUNT PROGRAM

§423.2300
Scope.
§423.2305
Definitions.
§423.2310
Condition for coverage of drugs under Part D.
§423.2315
Medicare Coverage Gap Discount Program Agreement.
§423.2320
Payment processes for Part D sponsors.
§423.2325
Provision of applicable discounts.
§423.2330
Manufacturer discount payment audit and dispute resolution.
§423.2335
Beneficiary dispute resolution.
§423.2340
Compliance monitoring and civil money penalties.
§423.2345
Termination of Discount Program Agreement.
rule

Subpart X—REQUIREMENTS FOR A MINIMUM MEDICAL LOSS RATIO

§423.2400
Basis and scope.
§423.2401
Definitions.
§423.2410
General requirements.
§423.2420
Calculation of medical loss ratio.
§423.2430
Activities that improve health care quality.
§423.2440
Credibility adjustment.
§423.2450
[Reserved]
§423.2460
Reporting requirements.
§423.2470
Remittance to CMS if the applicable MLR requirement is not met.
§423.2480
MLR review and non-compliance.
rule

Subpart Y—[RESERVED]

rule

Subpart Z—RECOVERY AUDIT CONTRACTOR PART C APPEALS PROCESS

§423.2600
Payment appeals.
§423.2605
Request for reconsideration.
§423.2610
Hearing official review.
§423.2615
Review by the Administrator.


For questions or comments regarding e-CFR editorial content, features, or design, email ecfr@nara.gov.
For questions concerning e-CFR programming and delivery issues, email webteam@gpo.gov.