Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 409, 417, 422, 423, and 424

[CMS-4159-P]

RIN 0938-AR37

Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Proposed rule.

SUMMARY:

The proposed rule would revise the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement statutory requirements; strengthen beneficiary protections; exclude plans that perform poorly; improve program efficiencies; and clarify program requirements. The proposed rule also includes several provisions designed to improve payment accuracy.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 7, 2014.

ADDRESSES:

In commenting, please refer to file code CMS-4159-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (please choose only one of the ways listed):

1.

Electronically.

You may submit electronic comments on this regulation to

http://www.regulations.gov

. Follow the “Submit a comment” instructions.

2.

By regular mail.

You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4159-P, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3.

By express or overnight mail.

You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4159-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4.

By hand or courier.

Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period: a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.

Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

Christopher McClintick, (410) 786-4682, Part C issues. Marie Manteuffel, (410) 786-3447, Part D issues. Kristy Nishimoto, (206) 615-2367, Part C and D enrollment and appeals issues. Whitney Johnson, (410) 786-0490, Part C and D payment issues. Clarisse Owens, (410) 786-0880, Part C and D compliance issues. Frank Whelan, (410) 786-1302, Part D improper prescribing issues.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received:

http://www.regulations.gov

. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Table of Contents

I. Executive Summary

A. Purpose

B. Summary of the Major Provisions

1. Eligibility of Enrollment for Individuals Not Lawfully Present in the United States

2. Modifying the Agent/Broker Requirements, Specifically Agent/Broker Compensation

3. Drug Categories or Classes of Clinical Concern

4. Improving Payment Accuracy

5. Risk Adjustment Data Requirements (§ 422.310)

C. Summary of Costs and Benefits

II. Background

III. Provisions of the Proposed Regulations

A. Clarifying Various Program Participation Requirements

1. Closing Cost Contract Plans to New Enrollment (§ 422.2 and § 422.503)

2. Two-Year Limitation on Submitting a New Bid in an Area Where an MA has been Required To Terminate a Low-Enrollment MA Plan (§ 422.504(a)(19))

3. Authority To Impose Intermediate Sanctions and Civil Money Penalties (§ 422.752, § 423.752, § 422.760 and § 423.760)

4. Contract Termination Notification Requirements and Contract Termination Basis (§ 422.510 and § 423.509)

5. Reducing the Burden of the Compliance Program Training Requirements (§ 422.503(b)(4)(vi)(C) and § 423.504(b)(4)(vi)(C))

6. Changes To Audit and Inspection Authority (§ 422.503(d)(2) and § 423.504(d)(2))

7. Procedures for Imposing Intermediate Sanctions and Civil Money Penalties Under Parts C and D (§ 422.756 and § 423.756)

8. Timely Access to Mail Order Services (§ 423.120)

9. Collections of Premiums and Cost Sharing (§ 423.294)

10. Enrollment Eligibility for Individuals Not Lawfully Present in the United States (§§ 417.2, 417.420, 417.422, 417.460, 422.1, 422.50, 422.74, 423.1, 423.30, and 423.44)

a. Basic Enrollment Requirements

b. Medicare Eligibility and Lawful Presence

c. Alignment of MA, PDP, and Cost Plan Eligibility With FFS Payment Exclusion Policy

11. Part D Notice of Changes (§ 423.128(g))

12. Separating the Annual Notice of Change (ANOC) From the Evidence of Coverage (EOC) (§ 422.111(a)(3) and § 423.128(a)(3))

13. Agent/Broker Requirements, Particularly Compensation (§ 422.2274 and § 423.2274).

14. Drug Categories or Classes of Clinical Concern and Exceptions (§ 423.120(b)(2)(v) and (vi))

a Categories or Classes of Clinical Concern

b. Criteria Necessary To Identify Categories and Classes of Clinical Concern

c. Exceptions

d. Analysis and Identification of the Categories or Classes of Clinical Concern

15. Medication Therapy Management Program (MTMP) Under Part D (§ 423.153(d))

a. Multiple Chronic Diseases

b. Multiple Part D Drugs

c. Annual Cost Threshold

16. Business Continuity for MA Organizations and PDP Sponsors (§ 422.504(o) and § 423.505(p))

17. Requirement for Applicants or Their Contracted First Tier, Downstream, or Related Entities To Have Experience in the Part D Program Providing Key Part D Functions

18. Requirement for Applicants for Stand Alone Part D Plan Sponsor Contracts to Be Actively Engaged in the Business of the Administration of Health Insurance Benefits (§ 423.504(b)(9))

19. Limit Parent Organizations to One Prescription Drug Plan (PDP) Sponsor Contract Per PDP Region

20. Limit Stand-Alone Prescription Drug Plan Sponsors to Offering No More Than Two Plans Per PDP Region

21. Efficient Dispensing in Long Term Care Facilities and Other Changes (§ 423.154)

a. Prohibition on Payment Arrangements That Penalize the Offering and Adoption of More Efficient LTC Dispensing Techniques (§ 423.154)

b. Misinterpretation of Language as Requiring the Proration of Dispensing Fees (§ 423.154)

c. Additional Waiver for LTC Pharmacies Using Restock and Reuse Dispensing Methodologies Under Certain Conditions (§ 423.154)

d. Technical Change To Eliminate Requirement That PDP Sponsors Report on the Nature and Quantity of Unused Brand and Generic Drugs (§ 423.154)

22. Applicable Cost-Sharing for Transition Supplies: Transition Process Under Part D § 423.120(b)(3)

23. Medicare Coverage Gap Discount Program and Employer Group Waiver Plans (§ 423.2325)

24. Interpreting Non Interference Provision (§ 423.10)

25. Pharmacy Price Concessions in Negotiated Prices (§ 423.100)

26. Payments to PDP Plan Sponsors For Qualified Prescription Drug Coverage (§ 423.308) and Payments to Sponsors of Retiree Prescription Drug Plans (§ 423.882)

27. Preferred Cost Sharing (§ 423.100 and § 423.120)

28. Prescription Drug Pricing Standards and Maximum Allowable Cost (§ 423.505(b)(21))

29. Any Willing Pharmacy Standard Terms & Conditions (§ 423.120(a)(8))

a. Preferred Cost Sharing

b. Extended Days' Supply

c. Mail Order Cost Sharing

30. Enrollment Requirements for the Prescribers of Part D Covered Drugs (§ 423.120(c)(5) and (6))

31. Improper Prescribing Practices and Patterns

a. Background and Program Integrity Concerns

b. Drug Enforcement Administration (DEA) Certification of Registration

c. Proposed Provisions

(1) DEA Certificate and State Authority

(2) Patterns or Practices of Prescribing

(a) Grounds for Revocation

(b) Criteria To Be Considered

32. Transfer of TrOOP Between PDP Sponsors Due to Enrollment Changes During the Coverage Year (§ 423.464)

a. Exclusion From TrOOP of Increased Cost Sharing Amounts Incurred Due to Secondary COB (§ 423.100)

b. Transfer of TrOOP Between PDP Sponsors Due to Enrollment Changes During the Coverage Year (§ 423.464)

33. Broadening the Release of Part D Data

34. Establish Authority to Directly Request Information From First Tier, Downstream, and Related Entities (§ 422.504(i)(2)(i) and § 423.505(i)(2)(i))

35. Eligibility of Enrollment for Incarcerated Individuals (§ 417.422, § 417.460, § 422.74, and § 423.44)

a. Changes in Definition of Service Area for Cost Plans (§ 417.422(b))

b. Involuntary Disenrollment for Incarcerated Individuals Enrolled in MA, PDP and Cost Plans (§ 417.460, § 422.74, and § 423.44)

36. Rewards and Incentives Program Regulations for Part C Enrollees (§ 422.134)

37. Expand Quality Improvement Program Regulations (§ 422.152)

38. Authorization of Expansion of Automatic or Passive Enrollment Non-Renewing Dual Eligible SNPs (D-SNPs) to Another D-SNP to Support Alignment Procedures (§ 422.60)

B. Improving Payment Accuracy

1. Implementing Overpayment Provisions of Section 1128J(d) of the Social Security Act (§ 422.326 and § 423.360)

a. Terminology (§ 422.326(a) and § 423.360(a))

b. General Rules for Overpayments (§ 422.326(a) Through (c) and § 423.360(a) Through (c))

c. Look-Back Period for Reporting and Returning Overpayments

2. Determination of Payments (§ 423.329)

3. Reopening (§ 423.346)

a. Part D Plan Payments Reopening

b. Coverage Gap Discount Reconciliation Reopening

4. Payment Appeals (§ 423.350)

5. Payment Processes for Part D Sponsors (§ 423.2320)

6. Risk Adjustment Data Requirements (§ 422.310)

7. RADV Appeals

a. Background

b. RADV Definitions

c. Publication of RADV Methodology

d. Proposal To Update RADV Appeals Terminology (§ 422.311)

e. Proposal To Simplify the RADV Appeals Process

(1) Issues Eligible for RADV Appeal

(2) Issues Not Eligible for RADV Appeals

(3) Manner and Timing of a Request for RADV Appeal

(4) Reconsideration Stage

(5) Hearing Stage

(6) CMS Administrator Review Stage

f. Proposal To Expand Scope of RADV Audits

g. Proposal To Clarify the RADV Medical Record Review Determination Appeal Burden of Proof Standard

h. Proposal To Change RADV Audit Compliance Date

8. Recovery Audit Contractor (RAC) Determination Appeals (Proposed Part 422 Subpart Z and Part 423 Subpart Z)

a. Background

b. Proposed RAC Appeals Process

(1) Reconsiderations (§ 422.2605 and § 423.2605)

(2) Hearing Official Determinations (§ 422.2610 and § 423.2610)

(3) Administrator Review (§ 422.2615 and § 423.2615)

C. Strengthening Beneficiary Protections

1. Providing High Quality Health Care (§ 422.504(a)(3) and § 423.505(b)(27))

2. MA-PD Coordination Requirements for Drugs Covered Under Parts A, B, and D (§ 422.112)

3. Good Cause Processes (§ 417.460, § 422.74 and § 423.44)

4. Definition of Organization Determination (§ 422.566)

5. MA Organizations May Extend Adjudication Timeframes for Organization Determinations and Reconsiderations (§ 422.568, § 422.572, § 422.590, § 422.618, and § 422.619)

D. Strengthening Our Ability To Distinguish Stronger Applicants for Part C and D Program Participation and To Remove Consistently Poor Performers

1. Two-Year Prohibition When Organizations Terminate Their Contracts (§ 422.502, § 422.503, § 422.506, § 422.508, and § 422.512)

2. Withdrawal of Stand-Alone Prescription Drug Plan Bid Prior to Contract Execution (§ 423.503)

3. Essential Operations Test Requirement for Part D (§ 423.503(a) and (c), § 423.504(b)(10), § 423.505(b)(28), and § 423.509)

a. Failing Essential Operations Test as Cause for Immediate Termination

b. Failing Essential Operations Test as Failure of a Qualification to Contract and Grounds for Nullification of Approval

4. Termination of the Contracts of Medicare Advantage Organizations Offering Part D for Failure for Three Consecutive Years To Achieve Three Stars on Both Part C and Part D Summary Star Ratings in the Same Contract Year (§ 422.510)

E. Implementing Other Technical Changes

1. Requirements for Urgently Needed Services (§ 422.113)

2. Skilled Nursing Facility Stays (§ 422.101 and § 422.102)

3. Agent and Broker Training and Testing Requirements (§ 422.2274 and § 423.2274)

4. Deemed Approval of Marketing Materials (§ 422.2266 and § 423.2266)

5. Cross-Reference Change in the Part C Disclosure Requirements (§ 422.111)

6. Managing Disclosure and Recusal in P&T Conflicts of Interest: [Formulary] Development and Revision by a Pharmacy and Therapeutics Committee Under PDP (§ 423.120(b)(1))

7. Definition of a Part D Drug (§ 423.100)

a. Combination Products

b. Barbiturates and Benzodiazepines

c. Medical Foods

8. Thirty-Six-Month Coordination of Benefits (COB) Limit (§ 423.466(b))

9. Application and Calculation of Daily Cost-Sharing Rates (§ 423.153)

10. Technical Change To Align Regulatory Requirements for Delivery of the Standardized Pharmacy Notice (§ 423.562)

11. Special Part D Access Rules During Disasters or Emergencies (§ 423.126)

12. MA Organization Responsibilities in Disasters and Emergencies (§ 422.100)

13. Termination of a Contract Under Parts C and D (§ 422.510 and § 423.509)

a. Cross-reference Change (§ 423.509(d))

b. Terminology Changes (§ 422.510 and § 423.509)

c. Technical Change To Align Paragraph Headings (§ 422.510(b)(2))

d. Terminology Change (§ 423.509(b)(2)(C)(ii))

14. Technical Changes To Align Part C and Part D Contract Determination Appeal Provisions (§ 422.641 and § 422.644)

a. Technical Changes (§ 422.641)

b. Technical Changes (§ 422.644(a) and (b))

15. Technical Changes To Align Parts C and D Appeal Provisions (§ 422.660 and § 423.650)

16. Technical Changes Regarding Intermediate Sanctions and Civil Money Penalties (§ 422.756 and § 423.756)

a. Technical Changes to Intermediate Sanctions Notice Receipt Provisions (§ 422.756(a)(2) and § 423.756(a)(2))

b. Cross-reference Changes (§ 422.756(b)(4) and § 423.756(b)(4))

c. Technical Changes (§ 422.756(d) and § 423.756(d))

d. Technical Changes To Align the Civil Money Penalty Provision With the Authorizing Statute (§ 422.760(a)(3) and § 423.760(a)(3))

e. Technical Changes To Align the Civil Money Penalty Notice Receipt Provisions (§ 422.1020(a)(2), § 423.1020(a)(2), § 422.1016(b)(1), and § 423.1016(b)(1))

17. Technical Change to the Restrictions on use of Information Under Part D (§ 423.322)

IV. Collection of Information Requirements

A. ICRs Related to Eligibility of Enrollment for Individuals Not Lawfully Present in the United States (§ 417.2, § 417.420, § 417.422, § 417.460, § 422.1, § 422.50, § 422.74, § 423.1, § 423.30, and § 423.44)

B. ICRs Related to Improper Prescribing Practices and Patterns (§ 424.535(a)(13) and (14))

C. ICRs Related to Applicants or Their Contracted First Tier, Downstream, or Related Entities To Have Experience in the Part D Program Providing Key Part D Functions (§ 423.504(b)(8)(i) through (iii))

D. ICRs Related to Eligibility of Enrollment for Incarcerated Individuals

E. ICRs Related to Rewards and Incentives Program Regulations for Part C Enrollees (§ 422.134)

F. ICRs Related to Expanding Quality Improvement Program Regulations (§ 422.152)

G. ICRs Related to Good Cause Processes (§ 417.460, § 422.74 and § 423.44)

H. ICRs Related to the Definition of Organization Determination (§ 422.566)

I. ICRs Related to Skilled Nursing Facility Stays (§ 422.101 and § 422.102)

J. ICRs Related to MA Organization Responsibilities in Disasters and Emergencies (§ 422.100)

K. ICR Related to Recovery Audit Contractor Determinations (Part 422, Subpart Z and Part 423, Subpart Z)

V. Response to Comments

VI. Regulatory Impact Analysis

A. Statement of Need

B. Overall Impact

C. Anticipated Effects

1. Effects of Closing Cost Contract Plans to New Enrollment

2. Effects of the Two-Year Limitation on Submitting a New Bid in an Area Where an MA Has Been Required To Terminate a Low-Enrollment MA Plan

3. Effects of the Authority To Impose Intermediate Sanctions and Civil Money Penalties

4. Effects of Contract Termination Notification Requirements and Contract Termination Basis

5. Effects of Reducing the Burden of the Compliance Program Training Requirements

6. Effects of Audit and Inspection Authority

7. Effects of the Procedures for Imposing Intermediate Sanctions and Civil Money Penalties Under Parts C and D

8. Effects of Timely Access to Mail Order Services

9. Effects of the Collections of Premiums and Cost Sharing

10. Effects of Enrollment Eligibility for Individuals Not Lawfully Present in the United States

11. Effects of Part D Notice of Changes

12. Effects of Separating the Annual Notice of Change (ANOC) From the Evidence of Coverage (EOC)

13. Effects of the Modification of the Agent/Broker Compensation Requirements

14. Effects of Drug Categories or Classes of Clinical Concern and Exceptions

15. Effects of the Medication Therapy Management Program (MTMP) Under Part D

16. Effects of the Business Continuity for MA Organizations and Part D Sponsors

17. Effects of the Requirement for Applicants or Their Contracted First Tier, Downstream, or Related Entities To Have Experience in the Part D Program Providing Key Part D Functions

18. Effects of Requirement for Applicants for Stand Alone Part D Plan Sponsor Contracts To Be Actively Engaged in the Business of the Administration of Health Insurance Benefits

19. Effects of Limit Parent Organizations to One Prescription Drug Plan (PDP) Sponsor Contract per PDP Region

20. Effects of Limit Stand-Alone Prescription Drug Plan Sponsors to Offering No More Than Two Plans per PDP Region

21. Effects of Efficient Dispensing and in Long Term Care Facilities and Other Changes

22. Effects of Applicable Cost-Sharing for Transition Supplies: Transition Process Under Part D

23. Effects of Medicare Coverage Gap Discount Program and Employer Group Waiver Plans

24. Effects of Interpreting the Non-Interference Provision

25. Effects of Pharmacy Price Concessions in Negotiated Prices

26. Effects of Payments to PDP Plan Sponsors for Qualified Prescription Drug Coverage and Payments to Sponsors of Retiree Prescription Drug Plans

27. Effects of Preferred Cost Sharing

28. Effects of Maximum Allowable Cost Pricing Standard

29. Effects of Any Willing Pharmacy Standard Terms & Conditions

30. Effects of Enrollment Requirements for the Prescribers of Part D Covered Drugs

31. Effects of Improper Prescribing Practices and Patterns

32. Effects of the Transfer of TrOOP Between Part D Sponsors Due to Enrollment Changes During the Coverage Year

33. Effects of Broadening the Release of Part D Data

35. Effects of Eligibility of Enrollment for Incarcerated Individuals

36. Effects of Rewards and Incentives Program Regulations for Part C Enrollees

37. Effects of Expand Quality Improvement Program Regulations

38. Effects of Authorization of Expansion of Automatic or Passive Enrollment Non-Renewing Dual-Eligible SNPs (D-SNPs) to Another D-SNP To Support Alignment Procedures

39. Effects of Improving Payment Accuracy: Reporting Overpayments, RADV Appeals, Part D Payment Reopening, LIS Cost Sharing, and Coverage Gap Discount Program

40. Effects of Part C and Part D RAC Determination Appeals

41. Effects of Requirement To Provide High Quality Health Care

42. Effects of MA-PD Coordination Requirements for Drugs Covered Under Part D

43. Effects of Revisions to Good Cause Processes

44. Effects of the Definition of Organization Determination

45. Effects of MA Organization Extension of Adjudication Timeframes for Organization Determinations and Reconsiderations

46. Effects of the Two-Year Prohibition When Organizations Terminate Their Contracts

47. Effects of the Withdrawal of Stand Alone Prescription Drug Plan Bid Prior to Contract Execution

48. Effects of Essential Operations Test Requirement for Part D

50. Effects of the Requirements for Urgently Needed Services

51. Effects of Skilled Nursing Facility Stays

52. Effects of Agent and Broker Training and Testing Requirements

53. Effects of Deemed Approval of Marketing Materials

54. Effects of Part C Disclosure Requirements

55. Effects of Managing Disclosure and Recusal in P&T Conflicts of Interest: Formulary Development and Revision by a Pharmacy and Therapeutics Committee Under Part D

56. Effects of the Technical Changes to the Definition of a Part D Drug

57. Effects of the Thirty-Sixth Month Coordination of Benefits (COB) Limit

58. Effects of Application and Calculation of Daily Cost-Sharing Rates

59. Effects of the Technical Change To Align Regulatory Requirements for Delivery of the Standardized Pharmacy Notice

60. Effects of the Special Part D Access Rules During Disasters

61. Effects of the MA Organization Responsibilities in Disasters and Emergencies

62. Effects of the Technical Changes Regarding the Termination of a Contract, Contract Determination and Other Appeals, and Intermediate Sanctions and Civil Money Penalties Under Parts C and D

63. Effects of the Technical Change to the Restrictions on Use of Information Under Part D

D. Expected Benefits

1. Drug Categories or Classes of Clinical Concerns and Exceptions

2. Medication Therapy Management Program Under Part D

E. Alternatives Considered

1. Separating the Annual Notice of Change From the Evidence of Coverage

2. Modifying the Agent/Broker Compensation Requirements

3. Medicare Coverage Gap Discount Program and Employer Group Waiver Plans

4. Prescription Drug Pricing Standards and Maximum Allowable Cost

5. Access to Covered Part D Drugs: Use of Standardized Technology

6. Any Willing Pharmacy Standard Terms and Conditions

7. Negotiated Prices

8. Preferred Cost Sharing

9. Transfer of TrOOP Between Part D Sponsors Due to Enrollment Changes During the Coverage Year

10. Part D Notice of Changes

11. Special Part D Access Rules During Disasters or Emergencies

12. Business Continuity for MAOs and Part D Sponsors

13. Drug Categories or Classes of Clinical Concerns and Exceptions

14. Medication Therapy Management Program (MTM) Under Part D

15. Requirement for Applicants or Their Contracted First Tier, Downstream, or Related Entities to Have Experience in the Part D Program Providing Key Part D Functions

F. Accounting Statement and Table

G. Conclusion

H pages

Regulations Text

Acronyms

ADS Automatic Dispensing System

AEP Annual Enrollment Period

AHFS American Hospital Formulary Service

AHFS-DI American Hospital Formulary Service-Drug Information

AHRQ Agency for Health Care Research and Quality

ALJ Administrative Law Judge

ANOC Annual Notice of Change

AO Accrediting Organization

AOR Appointment of Representative

BBA Balanced Budget Act of 1997 (Pub. L. 105-33)

BBRA [Medicare, Medicaid and State Child Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)

BIPA [Medicare, Medicaid, and SCHIP] Benefits Improvement Protection Act of 2000 (Pub. L. 106-554)

BLA Biologics License Application

CAHPS Consumer Assessment Health Providers Survey

CAP Corrective Action Plan

CCIP Chronic Care Improvement Program

CC/MCC Complication/Comorbidity and Major Complication/Comorbidity

CCS Certified Coding Specialist

CDC Centers for Disease Control

CHIP Children's Health Insurance Programs

CMP Civil Money Penalty

CMR Comprehensive Medical Review

CMS Centers for Medicare & Medicaid Services

CMS-HCC CMS Hierarchal Condition Category

CTM Complaints Tracking Module

COB Coordination of Benefits

CORF Comprehensive Outpatient Rehabilitation Facility

CPC Certified Professional Coder

CY Calendar year

DAB Departmental Appeals Board

DEA Drug Enforcement Administration

DIR Direct and Indirect Remuneration

DME Durable Medical Equipment

DMEPOS Durable Medical Equipment, Prosthetic, Orthotics, and Supplies

D-SNPs Dual Eligible SNPs

DOL U.S. Department of Labor

DUM Drug Utilization Management

EAJR Expedited Access to Judicial Review

EGWP  Employer Group/Union-Sponsored Waiver Plan

EOB Explanation of Benefits

EOC Evidence of Coverage

ESRD End-Stage Renal Disease

FACA Federal Advisory Committee Act

FDA Food and Drug Administration

FEHBP Federal Employees Health Benefits Plan

FFS Fee-For-Service

FIDE Fully-integrated Dual Eligible

FIDE SNPs Fully-integrated Dual Eligible Special Needs Plans

FMV Fair Market Value

FY Fiscal year

GAO Government Accountability Office

HAC Hospital-Acquired Conditions

HCPP Health Care Prepayment Plans

HEDIS HealthCare Effectiveness Data and Information Set

HHS [U.S. Department of] Health and Human Services

HIPAA Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191)

HMO Health Maintenance Organization

HOS Health Outcome Survey

HPMS Health Plan Management System

ICEP Initial Coverage Enrollment Period

ICL Initial Coverage Limit

ICR Information Collection Requirement

ID Identification

IRE Independent Review Entity

IRMAA Income-Related Monthly Adjustment Amount

IVC Initial Validation Contractor

LCD Local Coverage Determination

LEP Late Enrollment Penalty

LIS Low Income Subsidy

LPPO Local Preferred Provider Organization

LTC Long Term Care

MA Medicare Advantage

MAAA Member of the American Academy of Actuaries

MA-PD Medicare Advantage-Prescription Drug Plan

MAC Medicare Appeals Council

MIPPA Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275)

MOC Medicare Options Compare

MOOP Maximum Out-of-Pocket

MPDPF Medicare Prescription Drug Plan Finder

MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)

MS-DRG Medicare Severity Diagnosis Related Group

MSA Metropolitan Statistical Area

MSAs Medical Savings Accounts

MSP Medicare Secondary Payer

MTM Medication Therapy Management

MTMP Medication Therapy Management Program

NAIC National Association Insurance Commissioners

NCD National Coverage Determination

NCPDP National Council for Prescription Drug Programs

NCQA National Committee for Quality Assurance

NDA New Drug Application

NDC National Drug Code

NGC National Guideline Clearinghouse

NIH National Institutes of Health

NOMNC Notice of Medicare Non-Coverage

NPI National Provider Identifier

OIG Office of Inspector General

OMB Office of Management and Budget

OPM  Office of Personnel Management

OTC Over the Counter

Part C Medicare Advantage

Part D Medicare Prescription Drug Benefit Program

PBM Pharmacy Benefit Manager

PDE Prescription Drug Event

PDP Prescription Drug Plan

PFFS Private Fee For Service Plan

POA Present on Admission (Indicator)

POS Point-of-Sale

PPO Preferred Provider Organization

PPS Prospective Payment System

P&T Pharmacy & Therapeutics

QIC Qualified Independent Contractor

QIO Quality Improvement Organization

QRS Quality Review Study

PACE Programs of All Inclusive Care for the Elderly

RADV Risk Adjustment Data Validation

RAPS Risk Adjustment Payment System

RPPO Regional Preferred Provider Organization

SEP Special Enrollment Period

SHIP State Health Insurance Assistance Programs

SNF Skilled Nursing Facility

SNP Special Needs Plan

SPAP State Pharmaceutical Assistance Programs

SSA Social Security Administration

SSI Supplemental Security Income

T&C Terms and Conditions

TPA Third Party Administrator

TrOOP True Out-Of-Pocket

U&C  Usual and Customary

UPIN Uniform Provider Identification Number

USP U.S. Pharmacopoeia

I. Executive Summary

A. Purpose

The purpose of this proposed rule is to make revisions to the Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit Program (Part D) regulations based on our continued experience in the administration of the Part C and Part D programs and to implement certain provisions of the Affordable Care Act. The proposed changes are necessary to—(1) clarify various program participation requirements; (2) make changes to strengthen beneficiary protections; (3) strengthen our ability to identify strong applicants for Part C and Part D program participation and remove consistently poor performers; and (4) make other clarifications and technical changes.

B. Summary of the Major Provisions

1. Eligibility of Enrollment for Individuals Not Lawfully Present in the United States

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 makes individuals not lawfully present in the United States ineligible to receive federal benefits (such as Medicare), even if they are otherwise entitled to benefits. While we would not pay FFS claims for unlawfully present beneficiaries, MA, and Part D enrollment rules currently do not prevent the payment of capitation rates for these individuals. We are proposing to establish U.S. citizenship and lawful presence as an eligibility requirement for enrollment in MA and Part D plans.

2. Modifying the Agent/Broker Requirements, Specifically Agent/Broker Compensation

The current compensation structure is comprised of a 6-year cycle and is scheduled to end December 31, 2013. MA organizations and PDP sponsors provide an initial compensation payment to independent agents for new enrollees (Year 1), and pay a renewal rate (equal to 50 percent of the initial year compensation) for Years 2 through 6. This structure has proved to be complicated to implement and monitor, and the current structure creates an incentive for agents to move beneficiaries as long as the fair market value (FMV) continues to increase each year. To simplify the administration of these payments and reduce incentives for agents and brokers to encourage beneficiaries to enroll in plans without regard to ensuring plan benefits would meet the beneficiaries' health care needs, we are proposing to revise the existing compensation structure. Under our proposal, MA organizations and PDP sponsors would continue to have the discretion to decide, on an annual basis, whether to pay initial and/or renewal compensation payments to their independent agents. Also, for new enrollments, MA organizations and sponsors could make an initial payment that is no greater than the FMV amount, which we would set annually in our guidance that interprets these regulations. For renewals in Year 2 and subsequent years, the MA organization or sponsor could pay up to 35 percent of the FMV amount for that year. We believe that revising the existing compensation structure to allow MA organizations or Part D sponsors to pay up to 35 percent of the FMV for year 2 and subsequent years is appropriate based on a couple of factors. First, we believe that a 2 tiered payment system (that is, initial and renewal) would be significantly less complicated than a 3-tiered system (that is, initial, 50 percent renewal for years 2 through 6, and 25 percent residual for years 7 and subsequent years), and would reduce administrative burden and confusion for plan sponsors. Second, our analysis determined that 35 percent is the renewal compensation level at which the present value of overall payments under a 2-tiered system would be relatively equal to the present value of overall payments under a 3-tiered system (taking into account the estimated life expectancy for several beneficiary age cohorts). In addition to revising the agent and broker compensation structures, we propose to amend the training and testing requirements as well as setting limits on referral fees for agents and brokers.

3. Drug Categories or Classes of Clinical Concern

This proposed provision would interpret the Affordable Care Act authority to limit protected classes to those for which access to all drugs in a category or class for a typical individual with a disease or condition treated by the drugs in the class is required within 7 days and more specific formulary requirements would not suffice to meet multitude of specific applications of the drugs within the category or class. Instead of mandating coverage of all drug products in a particular class on all Part D formularies, we can save costs by identifying more efficient formulary requirements or other beneficiary protections in most cases.

4. Improving Payment Accuracy

The proposed regulatory provisions would implement the Affordable Care Act requirement that MA organizations and Part D sponsors report and return identified Medicare overpayments. We would adopt the statutory definition of overpayment for both Part C and Part D.

5. Risk Adjustment Data Requirements

The proposed rule would strengthen existing regulations at § 422.310 on MA plan sponsors' accountability for valid risk adjustment data prior to submission.

C. Summary of Costs and Benefits

Table 1—Summary of Costs and Benefits

Provision description

Total costs

Transfers

Changes to Audit and Inspection

We estimate that this change would require an annual cost of $7.95 million (total cost of $39.75 million) for the time and effort for all auditing organizations to perform the program audit. Additionally, we estimate an annual cost of $950,000 (total cost of 4.75 million) for MA organizations or Part D sponsors with audit results that reveal non-compliance to hire an independent auditor to validate that correction has occurred

Eligibility of enrollment for individuals not lawfully present in the U.S

N/A

We estimate that this change could save the MA program up to $5 million in 2015, increasing to $8 million in 2019 (total of $32 million over this period), and could save the Part D program (includes the Part D portion of MA-PD plans) up to $5 million in 2015, increasing to $9 million in 2019 (total of $35 million over this period).

Modifying the agent/broker requirements, specifically agent/broker compensation

N/A

Drug Categories or Classes of Clinical Concern

N/A

We estimate that this change could save the Part D program (includes the Part D portion of MA-PD plans) approximately $30 million in 2016, increasing to $420 million in 2019 (total of $720* million over this period).

Improving Payment Accuracy

N/A

Risk Adjustment Data Requirements

N/A

Transfer of TrOOP Between Part D Sponsors Due to Enrollment Changes during the Coverage Year

N/A

Eligibility of Enrollment for Incarcerated Individuals

We estimate that this change could save the MA program up to $27 million in 2015, increasing to $62 million in 2019 (total of $219 million over this period), and could save the Part D program (includes the Part D portion of MA-PD plans) up to $46 million in 2015, increasing to $90 million in 2019 (total of $333 million over this period).

* Projected savings are based upon full implementation of the criteria and do not reflect that changes for the antipsychotic class of drugs are deferred at this time.

II. Background

The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) created a new “Part C” in the Medicare statute (sections 1851 through 1859 of the Social Security Act (the Act)) which established what is now known as the Medicare Advantage (MA) program. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), enacted on December 8, 2003, added a new “Part D” to the Medicare statute (sections 1860D-1 through 42 of the Act) entitled the Medicare Prescription Drug Benefit Program (PDP), and made significant changes to the existing Part C program, which it named the Medicare Advantage (MA) Program. The MMA directed that important aspects of the Part D program be similar to, and coordinated with, regulations for the MA program. Generally, the provisions enacted in the MMA took effect January 1, 2006. The final rules implementing the MMA for the MA and Part D prescription drug programs appeared in the

Federal Register

on January 28, 2005 (70 FR 4588 through 4741 and 70 FR 4194 through 4585, respectively).

Since the inception of both Parts C and D, we have periodically revised our regulations either to implement statutory directives or to incorporate knowledge obtained through experience with both programs. For instance, on the September 18, 2008 and January 12, 2009

Federal Register

(73 FR 54226 and 74 FR 1494, respectively), we issued Part C and D regulations to implement provisions in the Medicare Improvement for Patients and Providers Act (MIPPA) (Pub. L. 110-275). We promulgated a separate interim final rule in January 16, 2009 (74 FR 2881) to address MIPPA provisions related to Part D plan formularies. In the final rule that appeared in the April 15, 2010

Federal Register

(75 FR 19678), we made changes to the Part C and D regulations which strengthened various program participation and exit requirements; strengthened beneficiary protections; ensured that plan offerings to beneficiaries included meaningful differences; improved plan payment rules and processes; improved data collection for oversight and quality assessment; implemented new policies; and clarified existing program policy.

In a final rule that appeared in the April 15, 2011

Federal Register

(76 FR 21432), we continued our process of implementing improvements in policy consistent with those included in the April 2010 final rule, and also implemented changes to the Part C and Part D programs made by recent legislative changes. The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted on March 23, 2010, as passed by the Senate on December 24, 2009, and the House on March 21, 2010. The Health Care and Education Reconciliation Act (Pub. L.

111-152), which was enacted on March 30, 2010, modified a number of Medicare provisions in Pub. L. 111-148 and added several new provisions. The Patient Protection and Affordable Care Act (Pub. L. 111-148) and the Health Care and Education Reconciliation Act (Pub. L. 111-152) are collectively referred to as the Affordable Care Act. The Affordable Care Act included significant reforms to both the private health insurance industry and the Medicare and Medicaid programs. Provisions in the Affordable Care Act concerning the Part C and D programs largely focused on beneficiary protections, MA payments, and simplification of MA and Part D program processes. These provisions affected implementation of our policies regarding beneficiary cost-sharing, assessing bids for meaningful differences, and ensuring that cost-sharing structures in a plan are transparent to beneficiaries and not excessive. In the April 2011 final rule, we revised regulations on a variety of issues based on the Affordable Care Act and our experience in administering the MA and Part D programs. The rule covered areas such as marketing, including agent/broker training; payments to MA organizations based on quality ratings; standards for determining if organizations are fiscally sound; low income subsidy policy under the Part D program; payment rules for non-contract health care providers; extending current network adequacy standards to Medicare medical savings account (MSA) plans that employ a network of providers; establishing limits on out-of-pocket expenses for MA enrollees; and several revisions to the special needs plan requirements, including changes concerning SNP approvals.

In a final rule that appeared in the April 12, 2012

Federal Register

(77 FR 22072 through 22175), we made several changes to the Part C and Part D programs required by statute, including the Affordable Care Act, as well as made improvements to both programs through modifications reflecting experience we have obtained administering the Part C and Part D programs. Key provisions of that final rule implemented changes closing the Part D coverage gap, or “donut hole,” for Medicare beneficiaries who do not already receive low-income subsidies from us by establishing the Medicare Coverage Gap Discount Program. We also included provisions providing new benefit flexibility for fully-integrated dual eligible special needs plans, clarifying coverage of durable medical equipment, and combatting possible fraudulent activity by requiring Part D sponsors to include an active and valid prescriber National Provider Identifier on prescription drug event records.

III. Provisions of the Proposed Regulations

A. Clarifying Various Program Participation Requirements

1. Closing Cost Contract Plans to New Enrollment (§ 422.2 and § 422.503(b)(5))

In implementing the original Part C requirements in our June 26, 1998 final rule, entitled, “Medicare Program; Establishment of the Medicare+Choice Program” (63 FR 34968 through 35116), we established a requirement in 42 CFR 422.501(b)(4) that an “entity seeking to contract as [an Medicare Advantage (MA)] organization must not accept new enrollees under a section 1876 reasonable cost contract in any area in which it seeks to offer [an MA] plan.” We stated our reasons for the policy, specifying in the preamble of the interim final rule that, “[o]ur reason for establishing this rule is to eliminate the potential for an organization to encourage higher-cost enrollees to enroll under its cost contract while healthy enrollees are enrolled in its risk-based [MA] plan. This [final] rule is consistent with our long-standing policy that entities not have both a risk and cost contract under section 1876 [of the Act] in the same area.” (63 FR 35014 through 35015).

This provision was recodified at 42 CFR 422.503(b)(5) in regulations implementing the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, but the requirement, as well as the rationale for the requirement, remained intact.

Since this requirement only precludes “the entity” contracting as an MA organization from having a cost contract open to new enrollment, the prohibition does not apply to another separate legal entity owned by the same parent organization, such that two legal entities owned by the same parent could offer a competing cost contract and MA plan. We do not believe that this result is consistent with the original intent of the prohibition because it permits legal entities that are related to each other under a common parent organization to offer a cost contract and MA plan in the same service area, creating the same potential for the entities to move higher risk enrollees from one plan to another in order to take advantage of the differing Medicare payment rules for the two plan types or for other reasons that are not related to the enrollees' best interests.

To ensure that our original intent is realized and to eliminate the potential for organizations to move enrollees from one of their plans to another based on financial or some other interest, we propose to revise paragraph § 422.503(b)(5) so that an, “entity seeking to contract as an MA organization must [n]ot accept, or share a corporate parent organization with an entity that accepts, new enrollees under a section 1876 reasonable cost contract in any area in which it seeks to offer an MA plan.”

In making the proposed revision to paragraph § 422.503(b), we also propose to add the definition of “parent organization” to § 422.2 of the MA program definitions. We would specify that, “Parent organization means a legal entity that owns one or more other subsidiary legal entities.” We are requesting comments on whether a parent organization with less than a 100-percent interest in a subsidiary legal entity should trigger the prohibition we propose with the amendment at § 422.503(b)(5). Although the MA program regulations do not currently define the term “parent organization,” our proposed definition is consistent with the way the term is currently used in the context of the MA program, for example, when assessing an organization's business structure.

2. Two Year Limitation on Submitting a New Bid in an Area Where an MA Has Been Required To Terminate a Low Enrollment MA Plan (§ 422.504(a)(19))

Under § 422.506(b)(1)(iv), we must non-renew an MA plan that does not have a sufficient number of enrollees to establish that it is a viable independent plan option. We have currently interpreted the standard of whether the MA plan has a “sufficient number of enrollees to establish that it is a viable independent plan option” as meaning that the MA plan has fewer than 500 enrollees for non-SNPs and fewer than 100 enrollees for SNPs over a specified time period of 3 years. As we determine adjustments are appropriate, we will revisit this interpretation as part of annual plan guidance. In cases in which an MA plan has been non-renewed on this basis, it would defeat the intent and purpose of this rule if the MA organization could simply submit a new bid for the next year in the same area for the same type of plan that failed to attract enrollment over a number of years. Indeed, the problem addressed in § 422.506(b)(1)(iv) would be exacerbated, as the new plan would start out with no MA enrollees.

In section 3209 of the Affordable Care Act, the Congress added a new section

1854(a)(5)(C)(1) of the Act that clarified that CMS is not “require[d] . . . to accept any or every bid submitted by an MA organization. . . .” Section 1856(b)(1) of the Act further provides authority for CMS to establish MA standards by regulation, and section 1857(e)(1) of the Act also provides authority to impose contract requirements that CMS finds “necessary and appropriate.” Under the foregoing authority, we propose to revise § 422.504(a) to add a new contract requirement that stipulates that the Medicare Advantage Organization (MA organization) agrees not to submit a new bid of the same type of plan that has been non-renewed under § 422.506(b)(1)(iv) in the same service area as the non-renewed plan for 2 years after such a non-renewal.

We believe this requirement will enhance our ongoing efforts to ensure that MA organization offerings in a service area present beneficiaries with viable plans that are responsive to their needs.

3. Authority To Impose Intermediate Sanctions and Civil Money Penalties (§ 422.752, § 423.752, § 422.760 and § 423.760)

Section 1857(a) of the Social Security Act (the Act) provides the Secretary with the authority to enter into contracts with MA organizations, and section 1860D-12(b)(1) of the Act provides the Secretary with the authority to enter into contracts with Part D sponsors. Section 1857(g)(1) of the Act provides a list of contract violations for which the potential enforcement response under section 1857(g)(2) of the Act is the imposition of intermediate sanctions (sanctions) and/or civil money penalties (CMPs). Section 1860D-12(b)(3)(E) of the Act applies these provisions to Part D contracts. We codified this authority in the June 28, 2000 final rule with comment period entitled, “Medicare Program; Medicare+Choice Program (65 FR 40170) for Part C, and the January 28, 2005 final rule entitled, “Medicare Program; Medicare Prescription Drug Benefit” (70 FR 4194) for Part D. The authority was codified at § 422.752 (Part C) and § 423.752 (Part D). We are proposing two changes to our existing authority to impose sanctions and CMPs.

First, section 6408 of the Affordable Care Act (Pub. L. 111-148) provided the Secretary with new authorities to impose sanctions or CMPs for violations of the Part C and D marketing and enrollment requirements. Section 6408 amended 1857(g)(1) of the Act by adding new sections (H) through (K). These provisions provide CMS with the authority to impose intermediate sanctions on an organization that enrolls an individual without prior consent (except in certain limited circumstances) or transfers an individual to a new plan without prior consent. They also specifically make it a contract violation to violate the Part C and D marketing requirements, and specify that it is a violation of the sponsor's Part C or D agreement with CMS for the sponsoring organization to employ or contract with any individual or entity who engages in the conduct described in paragraphs (A) through (J) of 1857(g)(1) of the Act.

We are proposing to revise our regulations to codify the aforementioned authorities at § 422.752 (Part C) and § 423.752 (Part D), following the statutory language with little modification.

Second, we are proposing changes to the regulations intended to clarify CMS' authority to impose CMPs for the violations contained in section 1857(g)(1) of the Act and corresponding regulations at § 422.752 (Part C) and § 423.752 (Part D). Existing regulations provide the government with authority to impose CMPs for the listed violations. The existing regulations, however, designate the Office of Inspector General (OIG) as the sole government agency with the authority to impose CMPs for the violations contained in § 422.752 and § 423.752. We are proposing to revise the language of these provisions to clarify that either CMS or the OIG may impose CMPs for the violations listed at § 422.752(a) and § 423.752(a), except § 422.752(a)(5) and § 423.752(a)(5). Only the OIG will continue to have the authority to impose CMPs for the violations at § 422.752(a)(5) and § 423.752(a)(5), regarding the misrepresentation and/or falsification of information furnished to CMS, an individual or other entity. CMS or the OIG will impose the CMPs in accordance with the amounts specified in section 1857(g)(2) of the Act and § 422.760 and § 423.760 of the corresponding regulations.

We are proposing to revise the existing regulations at § 422.752, § 423.752, § 422.760, and § 423.760 to effectuate this change.

4. Contract Termination Notification Requirements and Contract Termination Basis (§ 422.510 and § 423.509)

Sections 1857(c) and 1860D-12(b)(3)(B) of the Act provide us with the authority to terminate a Part C or D sponsoring organization's contract at any time if we make a determination that the contracting organization is substantially failing to meet contract requirements and expectations. Sections 1857(h)(1)(B) and 1860D-12(b)(3)(F) of the Act provide us with the procedures necessary to facilitate the termination of contracts held between CMS and MA organizations and Part D sponsors, respectively. The Part C contract termination authorities and procedures were codified into regulations in the June 29, 2000 final rule entitled, “Medicare Program; Medicare+Choice Program” (65 FR 40170) at § 422.510. Likewise, the Part D authorities and procedures were codified into regulations in the January 28, 2005 final rule entitled, “Medicare Program; Medicare Prescription Drug Benefit” (70 FR 4194) at § 423.509.

We are proposing three revisions to our existing regulations that relate to contract termination. First, we are proposing clarification of the scope of our authority to terminate Part C and D contracts under § 422.510(a) and § 423.509(a). Section 1857(c)(2) of the Act provides us with authority to terminate a Part C or D contract if we make a determination that the organization—

• Has failed substantially to carry out the contract;

• Is carrying out the contract in a manner inconsistent with the efficient and effective administration of this part; or

• No longer substantially meets the applicable conditions of this part.

Existing regulations at § 422.510 and § 423.509 reiterate the three bases for termination set forth in the statute, however, over time CMS has also included in regulation a number of specific violations within the scope of our statutory authority, that is, violations which meet the standard established by the statute. In the June 26, 1998 proposed rule (63 FR 34968, at 35018), we stated that “[i]n addition to repeating the above statutory language, we are implementing this language by identifying specific circumstances that we believe constitute examples of [an MA] organization substantially failing to carry out either its contract, or carrying out its contract in a manner that is inconsistent with the effective and efficient administration.”

However, we have come to believe over time that the inclusion of our broad statutory authorities in the regulations, along with the more specific violations, has the potential to lead to confusion regarding the scope of our termination authority. Terminating a contract is the strongest action that CMS may take in response to an MA organization or Part D sponsor's noncompliance. It is imperative that both CMS and affected organization understand the standard

we apply when CMS has made a determination to end the contractual relationship. Therefore, we are proposing to modify the language at § 422.510(a) and § 423.509(a) to clarify our contract termination authority by separating the statutory bases from the examples. To effectuate this change we will need to renumber the lists of bases contained in § 422.510(a) and § 423.509. Because there are cross references using the current numbering scheme, we are also proposing to make several corresponding reference changes to reflect the renumbering of this section throughout parts 422 and 423. We believe that by making these changes, we will improve the clarity of this regulation.

Second, we are proposing revisions to our contract termination notification procedures contained at § 422.510(b)(1) and § 423.509(b)(1). Current regulations state that if CMS decides to terminate a Part C or D sponsoring organization's contract, we must notify the MA organization/Part D sponsor in writing 90 days before the intended date of the termination. We believe that the 90-day timeframe is not in the best interest of Medicare beneficiaries, in light of the fact that CMS terminates contracts in circumstances where an organization is significantly out of compliance with Part C and D requirements. We also think that the 90-day timeframe is unnecessarily long given the existing procedural protections and appeal rights provided for MA organizations and Part D sponsors.

The authorizing statute for Part C, at section 1857(h)(1)(B) of the Act (applicable to Part D pursuant to section 1860D-12(b)(3)(F) of the Act), states that the Secretary must provide reasonable notice and opportunity for hearing regarding the termination (including the right to appeal the initial determination); during this hearing process, the termination is effectively stayed pursuant to § 422.664 and § 423.652. Therefore, we believe that a 45-day timeframe better balances the need to provide contracting organizations with reasonable notice of the impending contract termination with the interests of the Medicare beneficiaries who are enrolled in a plan that is deficient enough in its adherence to Part C and/or D requirements that contract termination is necessary. We also propose to make necessary cross-reference changes in parts 422 and 423 at § 422.644(c)(1) and § 423.642(c)(1).

Additionally, in an effort to respond to changes in the media and information technology landscape, we are proposing a slight modification to the termination notification provision for the general public at § 422.510(b)(1)(iii) and § 423.509(b)(1)(iii) by proposing that contracting organizations now release a press statement to news media serving the affected community or county and posting the press statement prominently on the organization's Web site instead of publishing the notice in applicable newspapers.

Third, we are proposing minor revisions to the wording of our regulations at § 422.510 and § 423.509 to reflect the authorizing language contained in sections 1857(c)(2) and 1860D-12 of the Act. Specifically, we are proposing to replace the word “fails” with “failed” in the applicable provisions of § 422.510 and § 423.509. In current regulations both of the terms failed and fails are used when describing contract violations that may be the basis for a contract termination. We would like for this list to read consistently, therefore, we are proposing to revise the language as such. The purpose of this change is merely to ensure that consistent language is used throughout § 422.510 and § 423.509 and in no way changes the meaning or policy encompassed in these provisions.

5. Reducing the Burden of the Compliance Program Training Requirements (§ 422.503(b)(4)(vi)(C) and § 423.504(b)(4)(vi)(C))

Section 1857(a) of the Act provides the Secretary with the authority to enter into contracts with MA Organizations, and section 1860D-12(b)(1) of the Act provides the Secretary with the authority to enter into contracts with Part D sponsors. Sections 1860D-12(b)(3)(D)(i) and 1857(e)(1) of the Act, specify that these contracts shall contain other terms and conditions that the Secretary may find necessary and appropriate. When we implemented the Part C program, we determined that all Part C contracts (and subsequently Part D contracts) would require that the Part C or D organization has the necessary administrative and management arrangements to have an effective compliance program, as reflected in § 422.503(b)(4)(vi) and § 423.504(b)(4)(iv).

In the December 5, 2007

Federal Register

, we published the “Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals and Intermediate Sanctions Process” final rule (72 FR 68700). In that final rule, we established that compliance plans for sponsoring organizations must include training and education and effective lines of communication between the compliance officer and the sponsoring organization's employees, managers, and directors as well as their first-tier, downstream and related entities (FDRs). We reiterated the importance of this requirement in the October 22, 2009 proposed rule entitled, “Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (74 FR 53634).

In the 2009 proposed rule, entitled, “Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs,” we addressed concerns about the burden on FDRs such as pharmacies, hospitals and physicians as a result of this requirement, given the likelihood that many of these entities and individuals contract with multiple contracting organizations. We were concerned that these FDRs would potentially have to participate in (largely duplicative) training for each organization with whom they contract. We requested public comments on how best to ensure that the training requirement continues to be met while not overly burdening the contracting organization or its FDRs. In response, we received numerous comments suggesting that CMS develop its own web-based trainings to lessen this burden on sponsors and FDRs (75 FR 19678 at 19688).

In response to these requests, we have created the CMS Standardized General Compliance Program Training and Education Module. Until now, we have offered this as an optional training. In this rule, we propose to require that all contracting organizations accept a certificate of completion of the CMS training as satisfaction of this general compliance program training requirement. We anticipate that this proposal will greatly reduce the burden on various sectors of the industry, including, but not limited to, insurance providers, hospitals, suppliers, pharmacists, and physicians.

Under this proposed change, Part D sponsors and Part C organizations would not be permitted to develop or implement sponsor specific training or provide supplemental training materials to fulfill the general compliance program training requirement; only CMS training would suffice.

We understand that sponsors often include sponsor specific information (such as compliance officer's contact information, compliance reporting processes and expectations, hotline number or email address for compliance questions, Web site information for accessing the sponsor's compliance policies and procedures) in the training materials provided to the FDRs and will need an appropriate mechanism for

conveying this information given that the training vehicle will no longer be available. To address this issue, a sponsor may choose to include such information in the contract held between the sponsor and the FDR. Alternatively, we would allow each sponsor to develop a one page information sheet containing this material, to be distributed by the sponsor to each of its FDRs. We seek comments concerning this portion of our proposal and suggestions on other options we could implement to accomplish the desired outcome.

We are proposing to modify the regulation text by adding a new § 422.503(b)(vi)(C)(3) and § 423.504(b)(vi)(C)(4) to permit only this CMS training for satisfaction of the requirement to train FDRs.

6. Changes to Audit and Inspection Authority (§ 422.503(d)(2) and § 423.504(d)(2))

Sections 1857(d)(2)(A) and 1860D-12(b)(3)(C) of the Act specify that each contract under these sections must state that CMS has the right to audit and inspect the facilities and records of each organization. We are proposing three changes to our audit and inspection authority. First, under section 6408 of the Affordable Care Act new authority was provided to the Secretary that now requires that each contract provide the right to “timely”: (1) Inspect or otherwise evaluate the quality, appropriateness, and timeliness of services performed under the contract; (2) inspect or otherwise evaluate the facilities of the organization when there is reasonable evidence of some need for such inspection; and (3) audit and inspect any books, contracts, and records of the organization that pertain to (a) the ability of the organization or its first tier or downstream providers to bear the risk of potential financial losses; or (b) services performed or determinations of amounts payable under the contract.

Therefore, we are proposing to revise both § 422.503(d)(2) and § 423.504(d)(2) to reflect this change. Specifically, we are proposing to insert the word “timely” at the end of both of the introductory paragraphs for § 422.503(d)(2) and § 423.504(d)(2).

Second, we are proposing to add authority that will allow CMS to require MA organizations and Part D sponsors to hire an independent auditor to perform full or partial program audits to determine compliance with CMS requirements.

MA organizations and Part D sponsors must adhere to CMS requirements to properly administer Part C and Part D benefits. These requirements are contained in statute, regulations and in the Part C and Part D sponsor agreements themselves. CMS needs assurance that MA organizations and Part D sponsors are substantially adhering to Part C and/or D requirements, and that Medicare beneficiaries are receiving the benefits to which they are entitled. To determine the extent of MA organization and Part D sponsor compliance with program requirements, CMS uses a variety of oversight and monitoring tools including CMS-conducted program audits.

CMS conducts a program audit by examining core operational areas and functions and determining the sponsors' level of compliance with these Part C and Part D program requirements. CMS may audit any program requirement, but in recent years we have focused on Part C and Part D coverage decisions, appeals, grievances, compliance program effectiveness, and formulary administration. CMS reviews a number of targeted samples to evaluate MA organizations and Part D sponsors' processes and systems. Targeting samples is an efficient way to highlight deficiencies and ensure that they are quickly and successfully remediated. The process is primarily designed to be educational for the MA organization and/or Part D sponsor as it expands the sponsor's understanding of CMS' expectations, and how program requirements are to be applied. It also identifies areas of risk or actual non-compliance so sponsors can quickly correct the deficiency. This understanding allows the MA organization and/or Part D sponsor to develop and implement a robust internal auditing and monitoring program to identify deficiencies before they reach a level of substantial non-compliance in the future. An effective monitoring program should result in early detection of system and process failures and should lead to problems being fixed quickly and steps being implemented to prevent future failures.

Organizations that are chosen for audit fall into at least one of the five following categories: High Star rated plans; sponsors with a Low Performing Icon (LPI); high risk plans (based on a data driven risk assessment); sponsors not audited in last 3 years, and CMS Regional or Central Office referrals. Annually, CMS conducts a risk assessment to determine which high-risk organizations to audit. Many of the program audits currently being conducted are with organizations whose contract performance or data indicators demonstrate the potential risk of failing to perform core program functions that, if not complied with, may result in potential beneficiary harm. These audits are a useful tool to help identify systemic deficiencies and failures in meeting CMS requirements and they help to promote compliance with those requirements. While these types of audits are necessary because these organizations pose the most risk, not all organizations are receiving the benefit of having an independent audit of their organization on a regular basis.

CMS is constrained in the number of program audits we can conduct each year, due to limited resources. Currently, CMS has close to 300 parent organizations that perform MA and/or Part D functions. CMS is only able to audit approximately 30 parent organizations per year; or roughly 10 percent of all MA organizations and/or Part D sponsors. CMS believes that MA organizations and/or Part D sponsors, their enrollees, and the Medicare program all benefit from a regular cycle of independent auditing. Therefore, we are proposing to revise our regulations to allow CMS to require MA organizations and/or Part D sponsors to hire an independent auditor to conduct regularly scheduled program audits in accordance with CMS specifications.

We currently make all of our program audit protocols available to MA organizations and/or Part D sponsors through our Web site. Pursuant to the proposed new regulatory provision, CMS would notify the MA organization and/or Part D sponsor that it has been selected to perform a full or partial program audit. The MA organization and/or Part D sponsor would then be required to engage an independent auditor to perform a full or partial program audit as directed by CMS using the CMS published protocols, methodologies, and methods of evaluation. At the conclusion of the audit, at the direction of the MA organization and/or Part D sponsor, the independent auditor will provide a draft copy of its findings to CMS and the MA organization and/or Part D sponsor. Once the MA organization and/or Part D sponsor has had an opportunity to rebut any findings, the independent auditor will provide its final report of findings to CMS and the MA organization and/or Part D sponsor. CMS anticipates that additional instruction will be necessary to interpret and implement this audit requirement of a complete and full independent review. Therefore, we intend to develop and release sub regulatory guidance to address, among other things, language and specifications which should be included in the contract between the sponsoring

organization and the independent auditor conducting the audit. The proposed authority will allow CMS to better evaluate MA organizations' and Part D plan sponsor's performance. With the proposed approach, each MA organization and/or Part D sponsor will be required to undergo an independent program audit at least every 3 years. Under this proposal, more organizations will be audited each year, which will provide CMS with substantially more data to evaluate program-wide performance, improve industry performance and protect beneficiaries enrolled in the Medicare Advantage and Prescription Drug Benefit programs. This will enhance CMS's oversight and provide us with information that enables us to focus our time and resources in the areas most needed to ensure compliance with Part C and Part D program requirements.

CMS will continue to perform program audits in limited scenarios, such as when indicated by a risk analysis; and will perform limited “look back” audits to ensure the integrity of the independent audit process proposed here. The latter audits will focus on reviewing the program audit findings that we receive from the independent auditors engaged by the Part C and Part D organizations, to ensure that the independent auditor conducted the audit in accordance with CMS specifications. We think that this additional authority will significantly strengthen the Medicare Parts C and D audit and oversight program.

Therefore, we are proposing to add language to § 422.503(d)(2) and § 423.504(d)(2) that will allow us to require a MA organization or Part D sponsor to hire an independent auditor, working in accordance with CMS specifications, to perform program audits to determine compliance with CMS requirements and provide to CMS an attestation affirming that the audit has been completed as required.

Third and finally, we are proposing to revise our regulations to specifically permit CMS to require MA organizations or Part D sponsors with audit results that reveal non-compliance with CMS requirements to hire an independent auditor to validate that correction has occurred. We may invoke this authority regardless of whether an independent auditor or CMS conducted the program audit that identified the programmatic deficiencies.

When program audits are conducted, non-compliance with CMS requirements is often found. When CMS finds these deficiencies, it notifies the MA organization or Part D sponsor of its non-compliance and requires correction. We do not close out audits until we have validated that correction has occurred. While we firmly believe in the value of such validation, these efforts are also limited by resources. In order to assist us in making the determination that the deficiencies found during the audit have been corrected and are not likely to recur, we need to have greater flexibilities in performing validation activities. Therefore, we are proposing that we may require a MA organization or Part D sponsor to hire an independent auditor to provide us with additional information to determine if the deficiencies found during the course of the audit have actually been corrected and are not likely to recur. The independent auditor would be hired by the MA organization and/or Part D sponsor and work in accordance with our specifications in order to provide accurate and reliable information to CMS.

CMS often relies on self-disclosed information from the MA organization or Part D sponsor, CMS and plan data; in the alternative, we must attempt to engage in a process to independently verify that deficiencies have been corrected. Given the nature and extent of some compliance deficiencies and the level of skill and experience required to conduct an exhaustive verification of correction, we have concluded that an independent auditor hired by the MA organization or Part D sponsor would be beneficial for both the organization and CMS.

This proposal is also consistent with our regulatory authority at 42 CFR 422.756 and 423.756 which permits us to require a sanctioned organization to hire an independent auditor to help us determine if a sanction should be lifted. Program experience has demonstrated other situations when the expertise of an independent auditor would be helpful in determining correction. For example, an independent auditor who specializes in complex information technology systems and who has specialized knowledge of how those systems interact with each other, in order to be compliant with our requirements, may be helpful in ensuring timely and successful correction of complex claims processing deficiencies. This is one example of a situation where we may require the MA organization or Part D sponsor to hire an independent auditor in order to assist in making the determination that the deficiencies found during the program audit have been corrected.

Therefore, we are proposing to add language to § 422.503(d)(2) and § 423.504(d)(2) that will allow us to require that a sponsoring organization hire an independent auditor, working in accordance with CMS specifications, to provide us with additional information to determine if the deficiencies that were found during a program audit have been corrected.

7. Procedures for Imposing Intermediate Sanctions and Civil Money Penalties Under Parts C and D (§ 422.756 and § 423.756)

Sections 1857(g) and 1860D-12(b)(3)(E) of the Act provide the Secretary the ability to impose intermediate sanctions on MA organizations and PDP sponsors. Intermediate sanctions consist of suspension of enrollment, suspension of marketing and suspension of payment. Current regulations governing intermediate sanctions are contained in subparts O of part 422 and part 423. Sections 422.756 and 423.756 provide specific procedures for imposing intermediate sanctions, and include provisions which address the duration of the sanction and the standard that we apply when determining if a sanction should be lifted. As specified in the Act and regulations, when intermediate sanctions are imposed on sponsoring organizations, the sanctions remain in place until we are satisfied that the basis for the sanction determination has been corrected and is not likely to recur.

Because sanctions remain in place until the deficiencies have been corrected and we are assured that they are not likely to recur, we are unable to fully test the contracting organization's compliance with certain requirements until the sanction is lifted. Therefore, in the October 2009 proposed rule, entitled “Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (74 FR 54634), we proposed a rule, later finalized in the April 15, 2010 “Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (75 FR 19678), that allows us to require a plan under a marketing and/or enrollment sanction to engage in a test period of marketing or accepting enrollments or both for a limited period of time. As we explained in that proposed rule, the purpose of the test period is to assist us in making a determination as to whether the deficiencies that are the bases for the intermediate sanctions have been corrected and are not likely to recur. The test period provides us with the opportunity to observe a sanctioned plan's ability to enroll or market to Medicare beneficiaries prior to lifting

the sanction. Since finalizing that rule in April 2010 (75 FR 19678), we have further considered its utility as a result of compliance issues that we have encountered over the past 2 years. We are proposing two modifications to this existing rule. First, we are proposing to expand the potential applicability of the test period requirement to all types of all intermediate sanctions. The existing regulation would only allow CMS to require this test period in instances where CMS has imposed a marketing and/or enrollment sanction. However, the type of intermediate sanction imposed is not necessarily related to the particular violations that form the basis for the sanction. Therefore, we are proposing to modify the existing rule to clarify that CMS may require a test period for a sponsoring organization that has had any of the three types of intermediate sanctions imposed: marketing, enrollment and/or payment.

We also want to clarify that our ability to require this test period is not limited to sanctions stemming from marketing or enrollment violations. In the preamble language for the October 2009 proposed rule, (74 FR 54634), we stated that “[t]he basis for this proposal is that we have found that there is often not a satisfactory way to determine if marketing and/or enrollment problems have been corrected while a sanction is in place and no such activities are permitted.” Upon reflection, we are concerned that this statement may have given the impression that the test period would only be used in instances where the underlying bases for the sanction are marketing and/or enrollment deficiencies. Therefore, we are clarifying here that the purpose of the test period is to assist us in making a determination as to whether the deficiencies that are the bases for the intermediate sanction have been corrected and are not likely to recur. The aforementioned deficiencies may be in any operational area, and are not limited or restricted to enrollment and/or marketing deficiencies.

Second, we are proposing to clarify the enrollment parameters for Part D contracting organizations that are under the benchmark and would normally participate in the annual and monthly auto enrollment process for beneficiaries who receive a low income subsidy (LIS) during a test period. During a test period, sanctioned Part D plans may not be allowed to receive or process these types of enrollments.

LIS beneficiaries are a vulnerable population who are particularly sensitive to financial instability. It is critical that Part D sponsors correctly identify a beneficiary's LIS status. Our goal when enrolling this particular population is to ensure that these vulnerable beneficiaries are best able to access their drugs and services in the manner to which they are entitled under the Part D program. We believe that if we allow auto-enrollments into a plan that has recently demonstrated substantial non-compliance with our regulations as evidenced by the imposition of an intermediate sanction, these vulnerable beneficiaries may experience difficulties in accessing prescription drugs. Therefore, we are proposing to make clear that we may determine that a sanctioned plan is not available to receive automatically assigned beneficiaries for the entire duration or a portion of the testing period.

We are proposing to modify the regulation text at § 422.756 and § 423.756 to reflect these changes.

8. Timely Access to Mail Order Services (§ 423.120)

Section 1860D 12(b)(3) of the Act authorizes the Secretary to include contract terms for Part D sponsors, not inconsistent with the Part C and D statutes, as necessary and appropriate. Section 423.120(a)(3) specifies that a Part D sponsor's contracted network may include non-retail pharmacies, including mail order pharmacies, so long as the network access requirements are met. Part D plans are increasingly entering into contracts with mail order pharmacies to offer beneficiaries an alternative way to fill prescriptions under the Part D benefit, often at much lower cost sharing than is available at network retail pharmacies. While mail order pharmacies make up a relatively small percentage of total prescriptions filled under the Part D program, we are committed to ensuring consistent and reliable beneficiary access to medications, regardless of what type of pharmacy fills the prescriptions.

Section 1860D-4 of the Act describes the various beneficiary protections in place in the Part D program. It is the industry standard in retail and institutional pharmacies to fill almost all prescriptions on the same day the prescription is presented. We have established a 24 hour fulfillment standard for home infusion drugs covered under Part D (§ 423.120(a)(4)(iv)). For mail order pharmacies, the industry standard for delivery times appears to range from 7 to 10 business days from the date the prescription was received, and Part D sponsors' marketing materials often specify this time frame to beneficiaries. Beneficiaries generally choose to fill prescriptions through a mail order pharmacy, for lower cost sharing, when it is feasible to wait 7 to 10 days to receive their medications. However, if this time frame is disrupted, beneficiaries may experience gaps in therapy.

We are aware of a specific instance in which significant incentives (for example, zero cost sharing) caused increased demand for mail order prescriptions sufficient to disrupt the delivery time frame, and we are concerned about the adverse effect such incentives might have on beneficiaries. When issues with filling a prescription arise in a retail setting, the beneficiary often is notified of the problem in real time, or within hours of discovery. When issues arise in a mail order setting, the delays in finding, communicating, and making the appropriate contacts to resolve the problem may add days onto the ultimate delivery date, resulting in a potentially more significant concern for mail order beneficiaries if these delays result in gaps in therapy. For this reason, we believe it is necessary and appropriate to establish fulfillment requirements for mail order pharmacies as well as home delivery services offered by retail pharmacies, to set consistent expectations for beneficiary access to drugs in this growing segment. Many beneficiaries may be very well served by this type of pharmacy access, but only if they can rely upon efficient processing and turnaround times. Mail order pharmacies contracted by Part D sponsors can reasonably be expected to meet minimum performance standards for order fulfillment, including convenient order turnaround times, as a beneficiary protection and as a component of providing good customer service. Clearly stating in beneficiary materials the expected turnaround time for delivery allows the beneficiary to better control when they need to reorder to ensure no gaps in medication supply. Clarity in expected turnaround times also can prevent needing to address customer inquiries into the status of a pending order, setting parameters for when an order is or is not delayed and what options become available at that point. We believe that established companies that have been providing these services for years have generally been meeting these standards in practice already, and that the proposed turnaround times are in line with current practices followed by mail order pharmacies today. Establishing mail order fulfillment requirements as a contract term would require plan sponsors to require that all pharmacies in its network meet the same minimum

level of service. This would underscore the importance of consistent and reliable access to medications, protecting beneficiaries from inconsistent or unreliable practices that may otherwise jeopardize timely access to prescriptions.

Therefore, we are proposing to amend § 423.120(a)(3) to specify mail order fulfillment requirements in line with what we have observed in other markets: 5 business days (from when the pharmacy receives the prescription order to when it is shipped) for those prescriptions requiring intervention beyond filling (such as clarifying illegible orders, resolving third party rejections, and coordinating with multiple providers as part of drug utilization management); and 3 business days (from when the pharmacy receives the prescription order to when it is shipped) for those prescriptions not requiring intervention. We recognize that some prescription orders may require clarification or additional steps to be taken by the provider or beneficiary that will extend beyond the proposed period of 5 days. We believe that such cases represent a minority of mail order prescriptions, and as such we would anticipate that more than 99 percent of all mail order prescriptions processed are filled in compliance with either the 3- or 5-day standard. We believe our proposed standards are in alignment with fulfillment requirements already in place in the market and as such do not create a new burden or new standard for mail order pharmacies to meet. We are soliciting comments not only on the proposed time frames, but also on whether there are instances (in addition to those discussed previously) in which the proposed 5-day time frame should apply.

We additionally are soliciting comments on whether we should establish additional requirements for beneficiary materials relating to mail order services, such as: clear definitions of processing time and delivery time; how to access customer support; how to submit a complaint via 1 800 MEDICARE; and beneficiary options for accessing medications when a delivery is lost or delayed.

We also welcome comments on any other requirements we should consider for mail order or other home delivery options. For example, also potentially affecting consistent access to medication is the use of mail order to fill initial prescriptions of new drugs or to fill 30-day supplies of chronically used medications. The need to order a refill early, allowing sufficient time for processing and delivery, can result in refill too soon edits based upon retail 30 day standards. Resolving inappropriate or inapplicable edits increases burden on the beneficiary and the mail order pharmacy and essentially creates a disincentive for beneficiaries who are planning ahead and attempting to order early enough to ensure un-interrupted supplies of chronic medications. In general, we believe that filling initial prescriptions or routine 30-day supplies at mail order is not good practice. We recognize that there may be a small minority of beneficiaries who successfully depend solely upon mail order or other home delivery options for access to prescription drugs due to particular circumstances of geography or mobility. We have no reason to discourage their continued use of these services. However, due to the difficulties reported to CMS with consistently and effectively filling short time frame supplies through mail order, we do not believe that Medicare beneficiaries in general should be incentivized through lower cost sharing to utilize mail order pharmacies for initial prescriptions or 30-day supplies.

9. Collections of Premiums and Cost Sharing (§ 423.294)

Since the beginning of the Part D program, when asked whether Part D sponsors could waive premiums and cost sharing we have responded that reducing or waiving either of these amounts would be inconsistent with the approved bid. The bid requirements, specified in section 1860D-11(e)(2)((C) of the Act, state the bid must reasonably and equitably reflect the revenue requirements of the expected population for the benefits provided under the plan. Waiving or reducing the cost sharing and/or premiums that are reflected in the approved bid would indicate that the plan bid was overstated and the amounts were not necessary for the provision of coverage. However, recently we have received reports of sponsors reducing or waiving cost-sharing and/or premiums. As a result, we propose to codify requirements for sponsor collection of cost sharing and premiums in regulation.

In addition to violating the bid requirements, as we noted in the preamble of the October 22, 2009 proposed rule entitled, “Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (74 FR 54690), waiving cost sharing or premiums also violates the uniform benefit requirements because doing so results in the plan's not providing the same coverage to all eligible beneficiaries within its service area. Section 1860D-2(a) of the Act defines qualified prescription drug coverage to mean access to standard or actuarially equivalent prescription drug coverage and access to negotiated prices (in accordance with section 1860D-2(d) of the Act). Thus, a Part D sponsor must offer its plan to all eligible beneficiaries residing in the plan's service area. We further interpret section 1860D-2(a) of the Act as requiring the provision of uniform premium and benefits and have codified these requirements in our regulations at § 423.104(b).

Once CMS has approved a sponsor's Part D benefit package, it cannot be varied for some or all of the plan's Part D enrollees. Thus, sponsors must commit to providing the level of benefits described in the sponsor's benefit package and cannot waive or reduce cost sharing, as that would violate the uniform benefit provisions set forth in § 423.104(b). This is true regardless of whether the Part D sponsor waives the copayment directly or indirectly through an affiliate, and regardless of whether such a waiver is prohibited by other laws. Some Part D sponsors are related to pharmacies through common ownership or control, and we note that an exception to the anti-kickback statute, set forth in section 1128B(b)(3)(G) of the Act, permits a pharmacy to waive cost sharing (that is, coinsurance and deductibles) imposed under Part D, if the conditions described in clauses (i) through (iii) of section 1128A(i)(6)(A) of the Act are met. These conditions include that the waiver is not advertised (through media outlets, telemarketing or otherwise) and is not routine, and the cost sharing is waived after a good faith determination that the individual is in financial need

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or reasonable efforts to collect the cost sharing have failed. This exception may protect from sanctions under the anti-kickback statute the waiver of cost sharing by pharmacies owned by Part D sponsors. However, as noted in the proposed rule, entitled “Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (74 FR 54690), sponsor failure to collect or attempt to collect cost sharing at the time the service is provided or to bill cost sharing to the appropriate party (either a beneficiary or another payer) after the fact, is a violation of the uniform benefit provisions set forth in the current regulation at § 423.104(b). The fact that cost sharing is waived by a pharmacy

that is related to a Part D sponsor by common ownership, rather than the Part D sponsor itself, and that it may be protected from sanctions under the anti-kickback statute, does not relieve the Part D sponsor of responsibility for this violation of the uniform benefit provisions. If a pharmacy is unrelated to a Part D sponsor and waives cost sharing under the conditions previously described, the pharmacy is making an independent business decision to which the Part D sponsor is indifferent. However, if an affiliated pharmacy waives cost sharing for a beneficiary enrolled in the sponsor's Part D plan, the sponsor is not indifferent because the cost-sharing waiver is more likely to be a strategic decision by the sponsoring organization to move market share to the related-party pharmacy and increase profits to the sponsor. Thus, the sponsor is altering the level of cost sharing in the approved bid in violation of the uniform benefit provisions in § 423.104(b). To clarify this for all parties, we propose to codify the prohibition of the waiver or reduction of premiums and cost sharing by adding a new section at § 423.294. We propose to specify that Part D sponsors either directly, or indirectly through related party pharmacies, as defined in regulation at § 423.501, are prohibited from reducing or waiving collection of premiums and cost sharing. In contrast, a pharmacy affiliated with one Part D sponsor may waive Part D cost sharing for beneficiaries enrolled Part D plans offered by other sponsors without violating the uniform benefit provisions.

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Under section 1128B(b)(3)(G) of the Act, an individual determination of financial need is not required for Part D beneficiaries eligible for the low-income subsidy under section 1860D-14 of the Act.

Additionally, we have become aware that the regulations in Part 423 do not address Part D sponsor requirements for refunding incorrect collections of premiums and cost sharing or for retroactively collecting underpayments of cost sharing. Therefore, we also propose to codify requirements at § 423.294 that mirror the language at § 422.270. We propose to apply the timeframe in § 423.466(a) to these refunds and recoveries. In other words, whenever a sponsor receives information that necessitates a retroactive refund of incorrect collections of premiums and/or cost sharing or collection of underpayments of cost sharing, the sponsor would be required to issue refunds or recovery notices within 45 days. For incorrect collections, we propose to duplicate the language at § 422.270 with one exception. That is, in the absence of authority to do so, we are not proposing to reduce Part D sponsor premiums for failure to refund amounts incorrectly collected from Part D enrollees. Instead, we propose that sponsors that fail to meet these requirements may receive compliance notices from CMS or, depending on the significance of the non-compliance, be the subject of an intermediate sanction (for example, suspension of marketing and enrollment activities) pursuant to Part 423, Subpart O.

10. Enrollment Eligibility for Individuals Not Lawfully Present in the United States (§ 417.2, § 417.420, § 417.422, § 417.460, § 422.1, § 422.50, § 422.74, § 423.1, § 423.30, and § 423.44)

a. Basic Enrollment Requirements

Sections 226 and 226A of the Act establish the conditions for Medicare Part A entitlement for individuals who have attained age 65, are disabled or have end-stage renal disease (ESRD), and are entitled to monthly Social Security benefits under section 202 of the Act. Individuals entitled to Part A under these sections do not have to pay premiums for such coverage, and they may, but are not required to, enroll in Medicare Part B. Section 1818 of the Act establishes the conditions for Medicare enrollment for individuals who are not entitled to monthly Social Security benefits under section 202 of the Act. Individuals covered under section 1818 of the Act must meet citizenship or alien status requirements, in addition to other requirements, in order to enroll in Part B. Individuals must have Part B in order to purchase Part A hospital insurance.

Sections 1851(a)(3)(B), 1860D-1(a)(3)(A), and 1876(a)(1)(A) of the Act outline the eligibility requirements to enroll in MA (Part C), Medicare prescription drug coverage (Part D), and Medicare cost plans. Under all options, individuals must have active Medicare coverage. Specifically, to enroll in MA, an individual must be entitled to benefits under Part A and be enrolled in Part B; to enroll in Part D, an individual must be entitled to Part A and/or enrolled in Part B; to enroll in a Medicare cost plan, an individual must be enrolled in Part B (Part A entitlement is not required).

b. Medicare Eligibility and Lawful Presence

Section 401 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), amended by section 5561 of the BBA, mandates that qualified aliens not lawfully present in the United States are not eligible to receive any federal benefit. This is outlined in 8 U.S.C. 1611 (Aliens who are not qualified aliens ineligible for federal public benefits) and 8 U.S.C. 1641 (Definitions). The definition of qualified alien is codified in 8 CFR 1.3 (Lawfully present aliens for purposes of applying for Social Security benefits).

The aforementioned provisions affect eligibility to receive benefits that would otherwise be payable under provisions in the Act. For example, aliens meeting certain criteria are able to earn qualified credits towards Social Security retirement benefits as outlined in 8 U.S.C. 1631 (Federal attribution of sponsor's income and resources to alien) and 8 U.S.C. 1645 (Qualifying quarters). Such individuals may earn the total number of qualified credits to be eligible under the Act to receive retirement benefits under sections 226 and 226A of the Act. However, should such individuals be unlawfully present in the United States under the previously mentioned PRWORA provisions, they are not eligible to receive the Social Security benefits they have earned for as long as they remain unlawfully present. At such time as they are lawfully present in the United States, or live outside the United States, they would again become eligible to receive Social Security payments.

Similarly, when aliens become eligible for Medicare based on age or disability under the terms of the Act, they would also automatically be entitled to premium free Part A benefits and be eligible to enroll in Part B during a valid enrollment period. Furthermore, aliens receiving Social Security retirement benefits 4 months prior to turning 65, or are in their 21st month of receiving Social Security disability benefits, would, under the terms of the Act, also automatically be enrolled into both Part A and Part B consistent with section 1837 of the Act and the enrollment process outlined in § 407.17. Again, however, under PRWORA, these individuals are not eligible to receive payment of Medicare benefits for so long as they are unlawfully present in the United States. Only upon becoming lawfully present would they become eligible to receive the Medicare benefits to which they would otherwise be entitled by paying into Social Security for the requisite number of quarters or paying premiums.

We note that current regulations at § 406.28 and § 407.27 outline the reasons for loss of premium Part A and Part B enrollment, and do not include the absence of lawful presence or citizenship as a reason for loss of entitlement. Individuals who are entitled to Part A and enrolled in Part B based on eligibility of Social Security benefits currently may be enrolled in

Medicare even if they are not lawfully present in the United States.

When PRWORA was enacted, the Act was not amended to include the additional eligibility criteria for entitlement to either Social Security benefits or for Medicare Part A entitlement, nor were new provisions put into place regarding termination of entitlement or establishment of a special enrollment period to account for situations in which individuals reestablished lawful presence. As a result, individuals who meet the current statutory eligibility criteria have been reflected in CMS records as entitled to both Social Security benefits and Medicare coverage.

c. Alignment of MA, Part D, and Cost Plan Eligibility With Fee-For-Service (FFS) Payment Exclusion Policy

In order to implement 8 U.S.C. 1611 and ensure that individuals who are present in the United States unlawfully do not receive benefits, the Social Security Administration (SSA) established internal policies and procedures to suspend Social Security benefits during periods for which individuals are unlawfully present in the United States. Because Medicare entitlement flows from entitlement to Social Security retirement and disability benefits, Medicare also has implemented this provision through a payment exclusion process.

Under Medicare's payment exclusion process, data on lawful presence is transmitted to CMS from the Department of Homeland Security via regular data exchanges from SSA. Once the data is received by us, the lawful presence status is noted on an individual's record and is retained in the FFS claims processing systems. As a result, we deny payment of both Part A and Part B claims for non-citizens where lawful presence is not established on their record, and do so until individuals regain their lawful presence status. Although payment is being denied for claims, individuals who are “fully insured” per section 226 of the Act, maintain Part A entitlement and remain enrolled in Part B on CMS records as long as premiums are paid. Similarly, individuals who are enrolled in premium Part A and/or Part B, maintain their enrollment status as long as premiums are paid.

Although CMS implementation of the lawful presence criteria in the FFS program achieved the intent of PRWORA by preventing FFS payments for services rendered to individuals who are not lawfully present, this policy was not adopted in regulations for Part A and Part B eligibility in 42 CFR parts 406 and 407 or addressed in regulations or subregulatory guidance for MA, Part D, and Medicare cost plans. Thus, individuals who are not lawfully present, but are nevertheless shown on CMS records to be entitled to Medicare Part A and/or enrolled in Part B, have been able to enroll in MA, Part D, and Medicare cost plans and obtain Medicare coverage for which they should not be eligible under 8 U.S.C. 1611. By permitting these MA, Part D and cost plan enrollments to remain in place, we are allowing improper payments to be made to plans on behalf of these individuals, which in turn impacts the Medicare Trust Funds. In addition, MA organizations, PDP sponsors and cost plans are making benefit payments under the Medicare program on behalf of these enrollees that are similarly prohibited under PRWORA.

Therefore, we are proposing to align eligibility for enrollment in MA, Part D, and cost plans (and resulting Medicare payments to plans and by plans that violate PRWORA) with the FFS payment exclusion policy to ensure that Medicare is only paying for services rendered to individuals who are eligible to receive them. These steps are consistent with recommendations made by the Office of Inspector General in its January 2013 report (A-07-12-01116) regarding the need for CMS to maintain adequate controls to prevent and detect improper payments for Medicare services rendered to unlawfully present beneficiaries. Accordingly, we are proposing to revise the regulations to establish U.S. citizenship and lawful presence as eligibility requirements for enrollment in MA, Part D, and cost plans. Further, we propose that individuals who are not lawfully present in the United States would be involuntarily disenrolled from MA, Part D, and cost plans, based on the date on which they lose their lawful presence status. Disenrollments would be effective the first of the month following the loss of eligibility, and the disenrollment process would follow that currently set forth in the regulations when an individual is no longer eligible to be enrolled in a plan.

These regulatory changes would prevent an individual from enrolling in a plan and/or remaining enrolled in a plan if they are not lawfully present in the United States. Affected individuals will retain their Medicare entitlement and remain enrolled in FFS, as long as premiums continue to be paid, but MA, Part D and cost plan payments would be denied for time periods during which the individuals are not lawfully present in the United States. We must ensure that in administering the Medicare program, all programs are compliant with 8 U.S.C. 161l. Specifically, we are proposing the following to address the eligibility and disenrollment of individuals not lawfully present in the United States:

• Sections 417.420, 417.422, 422.50, and 423.30 would be amended to add lawful presence or United States citizenship as eligibility criteria for enrollment in a cost, MA, or Part D plan, respectively.

• Sections 417.460, 422.74, and 423.44 would be amended to require the involuntarily disenrollment of individuals from cost, MA or Part D plans when they lose lawful presence status.

Conforming changes would be made to § 417.2, § 422.1, and § 423.1 to outline the authority for the aforementioned requirements, in 8 U.S.C. 1611 (Aliens who are not qualified aliens ineligible for Federal public benefits).

11. Part D Notice of Changes (§ 423.128(g))

Section 1860D 4(a) of the Act requires Part D sponsors to disclose to beneficiaries information about their Part D drug plans in standardized form. The Act further directs Part D sponsors to include, as appropriate, information that MA organizations must disclose under section 1852(c)(1) of the Act, which includes a detailed description of benefits. (In guidance, we refer to the document containing this information and delivered to beneficiaries as the Evidence of Coverage (EOC).) To make informed decisions, enrollees need to understand how their benefits, including premiums and cost sharing, would change from one year to the next, should they reenroll in the same plan. (In guidance, we refer to the documents containing this information and delivered to beneficiaries as the Annual Notice of Change (ANOC).) And enrollees also need to be aware of changes that may take place during the course of the year as well. Part D regulations currently do not include language found in the Part C regulations at § 422.111(d) requiring notice of changes to the plan to be provided to CMS for review pursuant to procedures for marketing material review and to all enrollees at least 15 days prior to the annual coordinated election period. Given that guidance applicable to both programs discusses notice of changes, we propose to require, for Part D, delivery of an ANOC.

Specifically, we propose to adopt in Part D, with modifications, the language contained in § 422.111(d). As is the case with the Medicare Advantage

regulation, proposed § 423.128(g) would require that Part D sponsors submit their changes to us under the procedures contained in subpart V of part 423, and, for those changes taking effect on January 1, provide a notice of changes to all enrollees 15 days before the beginning of the annual election period. While part 422 requires a minimum of 30 days' notice before the effective date for all other changes, proposed § 423.128 would not impose that standard, but rather would state that Part D sponsors remain subject to all other notice requirements specified elsewhere in the Part D regulations. Our proposal reflects a programmatic difference between Parts C and D: Under Part D it is not unusual for access to drugs listed on a plan's formulary to change during the course of a year. Changes can include changes to formulary status, tier placement, and utilization management or other restrictions. It is vital that beneficiaries currently taking a drug receive timely notice before such changes take place in order that they can decide whether to, for instance, change drugs or request an exception to cover the drug. Accordingly, our regulations currently specify when sponsors must provide notice of these kinds of changes. Our proposal to require the delivery of an ANOC is not intended to disrupt or change those existing notice requirements.

We would also like to take this opportunity to comment on the particular importance for Part D sponsors to provide notice in the ANOC of any changes they are making that will affect the amount of cost sharing which enrollees must pay for each drug belonging to a specific tier. As has been articulated in guidance, we continue to expect that sponsors will provide notice of such changes to all enrollees, including enrollees moved to a consolidated plan. Generally, sponsors compare numbers for the same plan from one year to the next in the ANOC. However, comparing numbers for the same plan would not benefit individuals moved from one plan to another. For instance, when a sponsor crosswalks members from a non-renewing plan to a consolidated renewal plan from one year to the next, cost sharing may change at the drug-tier level. For example, an enrollee who previously had zero cost sharing for all covered Part D drugs within the preferred generic tier may find that the consolidated plan now requires copays for drugs in that tier depending on how many months' supplies he or she orders, and whether he or she obtains those drugs at a retail level pharmacy or through mail order. We continue to expect that enrollees will receive ANOCs that clearly compare the non-renewed and consolidated plans' copayments or coinsurance for all drugs within each tier.

12. Separating the Evidence of Coverage (EOC) From the Annual Notice of Change (ANOC) (§ 422.111(a)(3) and § 423.128(a)(3))

As provided in sections 1852(c)(1) and 1860D-4(a) of the Act, MA organizations and Part D sponsors must disclose detailed information about the plans they offer to their enrollees. This detailed information is specified in section 1852(c)(1) of the Act and § 422.111(b) and § 423.128(b) of the Part C and Part D program regulations, respectively.

Under § 422.111(a)(3), we require MA plans to disclose a detailed plan description to each enrollee “at the time of enrollment and at least annually thereafter, 15 days before the annual coordinated election period.” A similar rule for Part D sponsors is found at § 423.128(a)(3). The content of the annual plan description is provided in paragraph (b) of the respective regulations. This is commonly referred to as the EOC. In addition, under § 422.111(d), we require MA organizations to notify all enrollees “at least 15 days before the beginning of the Annual Coordinated Election Period” of any changes that will take effect on January 1 of the next plan year. This notification is commonly referred to as the ANOC. Although our Part D guidance calls for Part D sponsors to provide an ANOC, there currently is not a regulatory requirement that they do so. Therefore, in the previous section of this proposed rule, we have proposed to codify such a requirement.

Prior to the 2009 contract year, these regulations required the provision of the EOC at the time of enrollment and at least annually thereafter but did not specify a deadline for the annual provision of the EOC. We permitted MA organizations and Part D sponsors to provide the EOC as late as January 31 of the applicable contract year. Therefore, prior to the annual coordinated election period (AEP) for the 2009 contract year, MA organizations and Part D sponsors may have provided the EOC and ANOC at different times. In the final rule entitled, “Medicare Program, Medicare Advantage and Prescription Drug Programs; Final Marketing Provisions” (73 FR 54220 and 54222), we required MA organizations to send the EOC at the same time as the ANOC (that is, 15 days before the AEP), with the result that the EOC was sent about 4 months earlier. Our rationale for this requirement was to provide beneficiaries with comprehensive information prior to the AEP. In addition, the consolidated mailing reduced the number of mailings to enrollees and eliminated duplicative information. However, we have found through consumer testing that beneficiaries receive multiple documents from their plans and CMS during the AEP that address similar topics, which at times beneficiaries find confusing or overwhelming. The ANOC, which is much shorter than the EOC, is intended to convey all of the information essential to a beneficiary's decision to remain enrolled in the plan or choose another plan during the AEP. Research based on the consumer testing suggests that participants were more likely to review the ANOC if it was not included with the EOC. For example, when asked about the utility of each document, many participants stated that they would read the ANOC as soon as they received it, and use it more often than a combined ANOC/EOC because the combined document is too much to worry about, too wordy, and/or too difficult to find information in compared to just the ANOC.

We have also found that sending the EOC months earlier has led to some unintended consequences. Specifically, the earlier deadline shortens the production time and affects the MA organization's or Part D sponsor's ability to produce an EOC that provides accurate benefit information in accordance with CMS required timeframes, which results in plans sending and beneficiaries receiving additional mailings containing errata sheets. We have reviewed plan ANOC/EOC documents for errors and found that, of the total number errors found, EOCs contain significantly more errors (86 percent) than the ANOCs (14 percent), which leads us to believe that allowing plans to have additional time to prepare EOCs would allow them to produce EOCs with fewer errors. Additionally, resources are wasted when beneficiaries are sent a combined ANOC and EOC, but ultimately decide to enroll in a different plan, and have no need for the EOC.

In order to help current members make timely and informed decisions about plan choices for the next year while ensuring that they continue to receive all the post-enrollment information necessary in a timely manner, we believe it would be more effective for them to receive an ANOC before the AEP, and then receive the EOC from the plan he or she chooses for

the next year after enrollment is effective. Therefore, we propose to require MA organizations and Part D sponsors to ensure that their current members receive the ANOC 15 days prior to the AEP, and receive the EOC no later than December 31st, for the contract year taking effect the following January 1st. To accomplish this, we propose to amend § 422.111(a)(3) and § 423.128(c)(3) to remove the current deadline and insert “by December 31 for the following contract year.” The deadline established by § 422.111(d)(2) for provision of the ANOC would continue to be 15 days prior to the beginning of the AEP. In addition, as mentioned previously, we are proposing to amend § 423.128 to require Part D sponsors to provide a separate ANOC and to adjust the time frames for delivery accordingly.

13. Agent/Broker Compensation Requirements (§ 422.2274 and § 423.2274)

Section 103(b)(1)(B) of MIPPA revised the Act to charge the Secretary with establishing guidelines to ”ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the MA plan that is intended to best meet their health care needs.” Section 103(b)(2) of MIPPA revised the Act to apply these same guidelines to Part D sponsors. Our program experience indicates that some agents may encourage beneficiaries to enroll in plans that offer higher commissions without regard to whether plan benefits meet the beneficiaries' health needs. In recognition that agents and brokers play a significant role in providing guidance and advice to beneficiaries and are in a unique position to influence beneficiary choice, we had proposed, prior to the enactment of MIPPA, a rule to regulate agent and broker compensation. To implement the MIPAA provisions and relying in part on comments in response to our previously proposed rule, we adopted an interim final rule on September 18, 2008, entitled “Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Final Marketing Provisions” (73 FR 54208, at 54226), which, among other things, established the current compensation structure for agents and brokers in connection with Parts C and D. That rule remains significantly in place at § 422.2274 and § 423.2274, and our experience since then indicates that revision of the compensation requirements is appropriate to ensure that we continue to meet our statutory mandate.

The current compensation structure is comprised of a 6-year compensation cycle that began in contract year 2009. MA organizations and Part D sponsors were to provide an initial compensation payment to independent agents for new enrollees (year 1) and pay a renewal rate (equal to 50 percent of the initial year compensation) to independent agents for years 2 through 6. These rates were to be adjusted annually based on changes to the MA payment rates or Part D parameters as established by CMS. We later amended the regulations to allow MA organizations and Part D sponsors to compensate independent agents and brokers annually using an amount at or below the fair market value. (See the final rule with comment period entitled, “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Changes” (77 FR 22072) published in the April 12, 2012

Federal Register

.)

The 6-year cycle is scheduled to end at the end of CY 2013, on December 31, 2013. The first year, 2009, was considered to be the first renewal year, effectively making 2009 the second full year of compensation. Because our regulations were silent regarding compensation amounts for Year 7 and beyond, we stated in our Final Call Letter for Contract Year 2014, issued on April 1, 2013, that MA organizations and Part D sponsors could, at their discretion, pay agents and brokers the renewal amount for Year 7 and beyond. However, this subregulatory guidance was intended to be a temporary measure, pending changes to our regulations.

Under the current structure MA organizations and Part D sponsors pay an initial rate for the first year, and then a renewal payment of 50 percent of the initial compensation paid to the agent for years 2 through 6. This structure has proven to be complicated to implement and monitor as it requires the MA organization or Part D sponsor to track the compensation paid for every enrollee's initial enrollment, and calculate the renewal rate based on that initial payment. For example, assume that the same agent enrolls three beneficiaries; one in each of the 2012, 2013, and 2014 contract years. Beneficiary A is a new, initial enrollee in MA plan XYZ for CY2012. Assume that the fair market value (FMV) cut-off amount for agent services for CY 2012 is $400. Plan XYZ has decided that its initial compensation will be equal to the full FMV, resulting in a payment to the agent of $400. Beneficiary B is a new, initial enrollee in MA plan XYZ for CY2013. In CY2013, assume the FMV has increased to $420. Plan XYZ has again decided that its initial compensation will be equal to the full FMV for Beneficiary B, resulting in a payment to the agent of $420. Also in CY2013, Plan XYZ is required to pay a renewal amount of 50 percent of initial enrollment to the agent for Beneficiary A. Since the initial payment for Beneficiary A was $400, Plan XYZ will pay a renewal amount of $200. Beneficiary C is a new, initial enrollee in MA plan XYZ for CY2014. In CY2014, assume the FMV value has again increased to $430. The Plan's initial compensation is, again, equal to the full FMV. Plan XYZ's payments to the agent would be as follows: $430 for Beneficiary C (new, initial), $210 for Beneficiary B (renewal, 50 percent of the initial payment of the CY2013 FMV of $420), and $200 for Beneficiary A (50 percent of the initial payment of the CY2012 FMV of $400). Thus, Plan XYZ has to know, at any given time, the amount of the initial compensation for each plan year—going back as far as 2009—in which the member enrolled in order to pay the correct compensation amount to the agent. Moreover, MA organizations and Part D sponsors must first review CMS' reports to determine whether an initial or renewal payment should be made, and then combine that information with the FMV, or, if applicable, the plan's compensation set at less than the FMV, for each plan year to ensure the correct payments are made to agents. When these simple examples are multiplied by tens or thousands of members, the complexity and challenges associated with implementing the current compensation requirements becomes clear.

In addition to its complexity, we are concerned that the current structure creates an incentive for agents and brokers to move enrollees from a plan of one parent organization to a plan of another parent organization, even for like plan type changes. Currently, in these cases, the new parent organization would pay the agent 50 percent of the current initial rate of the new parent organization; not 50 percent of the original initial rate paid by the other parent organization. Thus, in cases where the FMV has increased, or the other parent organization pays a higher commission, the incentive exists for the agent to move beneficiaries from one parent organization to another. (See § 422.2274(a)(3) and § 423.2274(a)(3)). So, in the example provided previously, if Beneficiary A switched to Plan ABC for CY2014, Plan ABC would pay the same agent $215 (50 percent of the 2014 initial rate of $430), instead of the $200 renewal payment the agent would have received if Beneficiary A remained in

Plan XYZ. Although the mere $15 increase in the payment to the agent may not appear to be much of an incentive to move one enrollee, an agent would receive considerably more income by moving tens of enrollees to another plan.

Since 2008, we have received inquiries from MA organizations and Part D sponsors regarding the correct calculation of agent/broker compensation, and found it necessary to take compliance actions against MA organizations and Part D sponsors for failure to comply with the compensation requirements. To the extent that there is confusion about the exact levels or timing of compensation required, there could be an un-level playing field for MA organizations and Part D sponsors operating in the same geographic area. In addition, CMS' audit findings and monitoring efforts have shown that MA organizations and Part D sponsors are having difficulty correctly administering the compensation requirements. Therefore, we believe that simpler agent/broker compensation regulations that are easier to understand will better ensure that plan payments are correct and establish a level playing field that will further limit incentives for agents and brokers to move enrollees for financial gain.

We are proposing to revise the existing compensation structure for agents and brokers so that, for new enrollments, MA organizations and Part D sponsors could make an initial payment that is no greater than the FMV amount for renewals in Year 2 and beyond, the MA organization or Part D sponsor could pay up to 35 percent of the FMV amount for the renewal year, resulting in the renewal year payment changing each year if the MA organization or Part D sponsor chooses to pay 35 percent of the current FMV (that is, the renewal year FMV threshold). As we do now, we would interpret the FMV threshold in our annual guidance to MA organizations and Part D sponsors. This flexibility would enable MA organizations and Part D sponsors to better react to changes in the marketplace and adjust their compensation structures accordingly.

Under the proposed compensation structure, the calculations would be simpler than those required under the current rule, as shown in the following example:

Assume again that Beneficiary A is a new, initial enrollee in MA plan XYZ for CY2015. Assume the FMV for CY 2015 is $400. Plan XYZ has decided to pay the full FMV, resulting in a payment to the agent of $400. In CY2016, assume the FMV is $420. Again, Plan XYZ has decided to pay the maximum FMV for initial enrollments, so it pays the agent $420 for Beneficiary B, who is an initial enrollee. Plan XYZ has also decided to pay the maximum renewal payment (35 percent of the FMV), resulting in a payment of $147 ($420 x .35) to the agent for Beneficiary A. Thus, Plan XYZ's payments to its agents are based on the FMV for the contract year in question, regardless of when the beneficiary enrolled in the plan. That is, when making the renewal payment, Plan XYZ doesn't have to determine what the FMV was in the initial year, but only looks to the FMV for the current year and pays the chosen percentage up to the maximum 35 percent of the FMV established by CMS.

In order to implement these changes in the identical Part C and Part D regulations at, § 422.2274 and § 423.2274, we first propose to designate the definition of “compensation” as paragraph (a)(1) and to restate the fair market value limit on compensation for the initial year as paragraph (b)(1)(i). Second, we propose to combine the current (a)(1)(i)(B), which addresses payments for renewals, and (a)(1)(iii), which addresses the length of time that renewals should be paid, and designate the revisions as a new (b)(1)(ii). Thus, the new paragraph (b)(1)(ii) would state that plans may pay up to 35 percent of the current FMV and that renewal payments may be made for the second year of enrollment and beyond.

In addition, we propose to modify paragraph (a)(3) to remove the 6-year cap on the compensation cycle. Currently, paragraph (a)(3) refers to policies that are replaced with a like plan during the first year or the subsequent 5 renewal years. Since we are proposing to eliminate the 6-year cycle, our revised paragraph (b)(2) deletes the reference to the initial year and the 5 renewal years. By tying renewal compensation to the FMV for the renewal year, rather than the initial year of enrollment, our proposal reduces the financial incentives for an agent or broker to encourage Medicare beneficiaries to change plans, especially from one parent organization to another parent organization. As with the current regulation, we propose in paragraph (b)(2)(iii) that a change in enrollment to a new plan type be payable under the same rules that apply to an initial enrollment, regardless of whether the change is to an unlike plan type in the same parent organization or an unlike plan type in another parent organization. Note that, as with the current rule, our proposal only addresses compensation paid to independent agents and does not address compensation payable by an MA organization or Part D sponsor to its employees that perform services similar to agents and brokers.

For our proposed regulations, we considered several different alternatives, including prohibiting compensation payments entirely beyond year 6, permitting MA organizations and Part D sponsors to pay a residual payment for year 7 and subsequent years, and permitting existing renewal payments to continue. We also evaluated different renewal amounts, including a 50 percent renewal payment for years 2 through 6 with a continuing 25 percent residual payment for years 7 and beyond. The evaluation took into account different ages for an initial enrollment, as well as the life expectancy of beneficiaries. In the analysis, a continual renewal payment of 35 percent was similar in payout to the combination of a 50 percent payment for years 2 through 6 and a residual payment of 25 percent for year 7 and beyond. We believe that revising the existing compensation structure to allow MA organizations or Part D sponsors to pay up to 35 percent of the FMV for year 2 and beyond is appropriate based on a couple of factors. First, we believe that a two-tiered payment system (that is, initial and renewal) would be significantly less complicated than a three-tiered system (that is, initial, 50 percent renewal for years 2 through 6, and 25 percent residual for years 7 and beyond), and would reduce administrative burden and confusion for plan sponsors. Second, our analysis determined that 35 percent is the renewal compensation level at which the present value of overall payments under a two-tiered system would be relatively equal to the present value of overall payments under a three-tiered system (taking into account the estimated mortality rates for several beneficiary age cohorts). This analysis is based on the existing commission structure basing renewal commissions on the starting year initial commission amount and not the current year FMV amount. We welcome comments on both the amount of the renewal payment as well as the proposed indefinite time frame.

Current regulations at § 422.2274(a)(4) and § 423.2274(a)(4) address the timing of plan payments, as well as recovery of payments when a beneficiary disenrolls from a plan. Specifically, (a)(4) states that compensation may only be paid for the beneficiary's months of enrollment during the year (January through December). We propose to revise (a)(4) to define more clearly a plan year for

purposes of compensation. The annual compensation amount covers January 1 through December 31 of each year. We have learned that some plans have been paying compensation based on an annual cycle, rather than a calendar year cycle. We have taken appropriate compliance actions in those instances where we have evidence that an MA organization or Part D sponsor is paying compensation incorrectly, and issued sub-regulatory guidance on August 14, 2013 reminding organizations and sponsors that compensation is to be paid based on a calendar year cycle. Along the same lines, we propose to revise the language at § 422.2274(a)(4) to clarify that the payment made to an agent must be for January 1 through December 31 of the year and may not cross calendar years. For example, a renewal payment cannot be made for the period of November 1, 2013 through October 31, 2014. Rather, the renewal payment must cover January 1, 2013through December 31, 2013.

Currently, the regulation text at § 422.2274(a)(4) (i) permit payments to be made at one time or in installments and at any time. CMS proposes to change the timing of payments to require that payments may not be made until January 1 of the compensation year, and must be paid in full by December 31 of the compensation year. CMS believes this proposal is appropriate given the ability of beneficiaries to change plans during the annual coordinated election period (AEP), which runs from October 15 through December 7. That is, beneficiaries can choose a new plan during the AEP, and then revise that choice as many times as they desire during the AEP; the last enrollment choice made is the one that becomes effective on January 1 of the following year. Under CMS' current requirements, each MA organization or Part D sponsor would have to recoup compensation, if already paid, for every beneficiary that initially enrolled in their plan but later decided to enroll in a different parent organization prior to January 1. Under the proposed rule, MA organizations and Part D sponsors would not be allowed to pay compensation until the beginning of the calendar year, when the final AEP enrollment becomes effective. Thus, the proposed rule would simplify MA organizations' and sponsors' compensation processes and enable them to make more accurate payments. We welcome comments on this proposal.

Current regulations at § 422.2274(4)(ii)(A) and § 423.2274(4)(ii)(A) require MA organizations and Part D sponsors to recover compensation paid to agents when a beneficiary disenrolls from a plan within the first three months of enrollment. However, in sub-regulatory guidance, we have recognized several circumstances (for example, death of the beneficiary, the beneficiary moves out of the service area, the beneficiary becomes eligible to receive LIS, or the beneficiary loses Medicaid benefits) in which plans should not recover compensation even though the beneficiary was enrolled in the plan for less than 3 months. In circumstances such as these, since the disenrollment decision could not be based on agent or broker behavior, we believe it to be appropriate for the agent to receive the compensation associated with the months that beneficiary was a member of the plan. While the plan would not recover the compensation for those months, it would recover any compensation paid for the months after the disenrollment. Therefore, CMS is proposing to combine paragraphs (a)(4)(ii)(A) and (a)(4)(ii)(B) into a revised paragraph (b)(3)(iii),which would include new text to clarify that plans should recover compensation for only the months that the beneficiary is not enrolled, unless the disenrollment took place within the first 3 months. Under our proposal, we would require disenrollments that are the result of agent or broker behavior to trigger recoupment of any compensation that has been paid for that period. In cases where disenrollment took place within the first 3 months and the disenrollment did not result from or could not have resulted from an agent's behavior, we would not require that compensation be recovered under our proposal. We would provide more specific information in sub-regulatory guidance, and welcome comments regarding possible examples to include in that guidance.

CMS also proposes here, in § 422.2274(h) and § 423.2274(h) to codify existing sub-regulatory guidance regarding referral (finder's) fees. CMS released a memorandum on October 19, 2011 addressing excessive referral fees, noting that referral fees should not exceed $100. CMS has long been concerned that some MA organizations or Part D sponsors can offer the entire amount of compensation an agent or broker receives through only a referral, while others must combine any compensation for referrals with other agent marketing activities while meeting the same total cap on compensation, thereby creating an un-level playing field within the marketplace and a clear financial incentive for the referring agent to steer beneficiaries to MA organizations or Part D sponsors that offer the higher amount, without regard to whether plan benefits meet the beneficiaries' health care needs. Therefore, we are proposing to limit the amount that can be paid as a referral fee to independent, captive, and employed agents and brokers, regardless of who completes the enrollment, to a reasonable amount specified by CMS, which is currently, for CY 2013, and CY 2014, $100. Furthermore, note that, under § 422.2274(a) and § 423.2274(a), CMS requires that referral fees paid to independent agents and brokers must be part of total compensation not to exceed the FMV for that calendar year.

14. Drug Categories or Classes of Clinical Concern and Exceptions (§ 423.120(b)(2)(v) and (vi))

Section 3307 of the Affordable Care Act amended section 1860D-4(b)(3)(G) of the Act by replacing the specific criteria established under MIPPA in 2008 to identify categories or classes of Part D drugs for which all Part D drugs therein shall be included on Part D sponsor formularies. The specified criteria were replaced with the requirement that the Secretary establish criteria through notice and comment rulemaking to identify drug categories or classes of clinical concern. In addition, section 3307 of the Affordable Care Act requires the Secretary to engage in rulemaking to establish any exceptions that permit a Part D sponsor to exclude from its formulary a particular Part D drug (or otherwise limit access to such drug through utilization management or prior authorization restrictions) within the drug categories or classes that meet the criteria established by the Secretary. The Affordable Care Act amendments to section 1860D-4(b)(3)(G) of the Act specified that until such time as the Secretary establishes the criteria to identify drug categories or classes of clinical concern through rulemaking, the following categories or classes shall be identified as categories or classes of clinical concern: anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants for the treatment of transplant rejection. We now propose to implement the Affordable Care Act requirements set forth in section 1860D-4(b)(3)(G) of the Act by revising § 423.120(b)(2)(v) and (vi) as follows: (1) the criteria the Secretary will use to identify drug categories or classes of clinical concern; and (2) the exceptions that permit Part D sponsors to exclude certain Part D drugs from within an identified drug category or class from

their formularies (or otherwise limit access to such drugs, including through utilization management or prior authorization restrictions). We also propose to specify drug categories or classes that would meet the proposed criteria and explain the process we used for making these determinations.

a. Categories or Classes of Clinical Concern

In 2005, well before the passage of MIPPA, and before the start date of the Part D program, we directed Part D sponsors through guidance to include on their formularies all or substantially all drugs in six categories or classes (antidepressants; antipsychotics; anticonvulsants; immunosuppressants for transplant rejection; antiretrovirals; and antineoplastics). Our authority for this policy arises from section 1860D-11(e)(2)(D)(i) of the Act, which requires that in order to approve a plan, we must not find that the design of the plan and its benefits (including any formulary and tiered formulary structure) are likely to substantially discourage enrollment by certain Part D eligible individuals. We refer to this as our “non-discrimination” policy. This statutory directive helped to ensure a smooth transition of the approximately 6 million Medicare-Medicaid beneficiaries who were converting from Medicaid drug coverage to Medicare drug coverage at the start of the Part D program. Under the existing circumstances, any formularies that did not have all or substantially all drugs in these categories or classes potentially would have been discriminatory for the Medicare-Medicaid beneficiary population because state Medicaid program formularies were generally open compared to the Part D formularies that we were anticipating prior to the beginning of the Part D program. Thus, it stood to reason that Medicare-Medicaid beneficiaries and many of their providers were largely unaccustomed to drug utilization management techniques. That is, for the most part they had little experience dealing with the rejection of a drug claim at the point of sale because the drug was either not on formulary, or another drug needed to be tried first, or because more information was required to determine whether the drug could be covered under the plan. Moreover, since the majority of the Medicare-Medicaid beneficiaries did not make a decision to elect their new plan, but were instead auto-enrolled, these individuals may not have understood whether their current medications would continue to be covered under their new Medicare plan. Since the Part D program would be administered by private plans with extensive experience managing prescription drug costs through tighter formularies and a variety of utilization management techniques, we anticipated the need for a learning curve and delays in negotiating appeals processes that might endanger the beneficiaries who needed access to drugs in these particular categories or classes. In order to mitigate the risks and complications associated with an interruption of therapy for vulnerable beneficiaries, who would be trying to navigate a new drug benefit when they attempted to fill or refill their first prescriptions under the Part D program on or after January 1, 2006, we created the special requirements for coverage of the six drug classes. However, the circumstances that existed when this policy was originally implemented have changed dramatically in the more than seven years the program has been in operation. CMS, Part D sponsors, our partners who assist beneficiaries with making enrollment choices, and particularly our Medicare-Medicaid beneficiaries and their advocates have had a great deal of experience working with Part D plans since 2005.

Section 176 of MIPPA added a new section 1860D-4(b)(3)(G)(i) to the Act requiring, effective with plan year 2010, that the Secretary identify certain categories or classes of drugs that meet two statutory specifications: (1) Restricted access to the drugs in the category or class would have major or life-threatening clinical consequences for individuals who have a disease or condition treated by drugs in such category or class; and (2) There is a significant need for such individuals to have access to multiple drugs within a category or class due to unique chemical actions and pharmacological effects of the drugs within a category or class, such as drugs used in the treatment of cancer. In addition, MIPPA provided the Secretary with the discretion to establish exceptions permitting Part D sponsors to exclude from their formularies, or to otherwise limit access to (including utilization management or prior authorization restrictions), certain Part D drugs in the protected categories or classes.

In the January 16, 2009

Federal Register

(74 FR 2881), we published an interim final rule with comment period (IFC) entitled, “MIPPA Drug Formulary and Protected Classes Policies.” This rule revised the regulations governing the Medicare Part D formularies to reflect the MIPPA requirements. We codified at § 423.120(b)(2)(v) the MIPPA provision requiring the inclusion of all Part D drugs in categories or classes that we identified as meeting the two conditions set forth in section 1860D-4(b)(3)(G)(i) of the Act. Given the limited timeframe then available for establishing and implementing a process to identify such drug categories or classes due to formulary submission deadlines, we maintained the existing six drug categories and classes of clinical concern for 2010 with the intention to propose and finalize a new process through rulemaking that would be used to identify drug categories or classes that met the MIPPA criteria for CY2011. After receiving comments in response to the January 16, 2009 IFC, entitled, “Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary Protected Classes Policies” that persuaded us that the further interpretative rulemaking was necessary, we published a notice of proposed rulemaking (NPRM) on October 22, 2009, entitled, “Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (74 FR 54634) to further refine the MIPPA criteria and establish a process that met MIPPA requirements. However, between the issuance of the October 22, 2009 proposed rule and the April 15, 2010 final rule (75 FR 19766), the Affordable Care Act was enacted. Section 3307 of the Affordable Care Act amended section 1860D-4(b)(3)(G) of the Act to specify that the existing drug categories or classes of clinical concern would remain so until such time as the Secretary establishes new criteria to identify drug categories or classes of clinical concern under section 1860D-4(b)(3)(G) of the Act through notice and comment rulemaking.

We are concerned that requiring essentially open coverage of certain categories and classes of drugs presents both financial disadvantages and patient welfare concerns for the Part D program as a result of increased drug prices and overutilization. The principal disadvantage is that an open coverage policy substantially limits Part D sponsors' ability to negotiate price concessions in exchange for formulary placement of drugs in these categories or classes. Since the beginning of the Part D program we have heard from stakeholders that this policy—frequently referred to as the “protected classes” policy—significantly reduces any leverage the sponsor has in price negotiations and results in higher Part D costs. A report by the OIG in March 2011 documented similar assertions from selected Part D sponsors, including assertions that “they received either no or minimal rebates for the drugs in these

six classes,” that “there is little incentive for drug manufacturers to offer rebates for these six classes of drugs because they do not need to compete for formulary placement,” and that “if [a rebate] is provided, it's probably at a lower percentage than [the rebate for the drugs] that had some competition.” (HHS Office of Inspector General, “Concerns with Rebates in the Medicare Part D Program”, March 2011, OEI-02-08-00050)

We are aware of other analyses that support these findings. A 2008 study conducted by the actuarial and consulting firm Milliman found that the six protected drug classes disproportionately accounted for between 16.8 percent and 33.2 percent of total drug spend among sponsors surveyed (Kipp RA, Ko C). (See “Potential cost impacts resulting from CMS guidance on ‘Special Protections for Six Protected Drug Classifications' and Section 176 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (PL 110-275)” available at:

http://amcp.org/WorkArea/DownloadAsset.aspx?id=9279

). Milliman reported that the Part D program administrators (plan sponsors and PBMs) commented that the protected status of these drug classes limited plan sponsors' ability to effectively negotiate lower costs with manufacturers since it is known that these drugs must be included on the formulary. The Milliman report estimated that affected drug costs were on average 10 percent higher than they would be in the absence of the protected class policy and that this represented $511 million per year in excess costs to beneficiaries and the Part D program. We note that numerous brand drug patents expire between now and 2015 which might reduce future cost projections. Another 2008 study from the National Bureau of Economic Research (NBER) suggested that while Medicare Part D led to a substantial decline in average pharmaceutical prices, Medicare-intensive drugs in protected classes did not experience price declines as did their counterparts not in protected classes and may have actually experienced price increases (Duggan M, Morton FS. 2010. “The Effect of Medicare Part D on Pharmaceutical Prices and Utilization,” American Economic Review, American Economic Association, vol. 100(1), pages 590-607). Plan sponsors can still negotiate with manufacturers for preferred or non-preferred tier placement of protected class drugs, but CMS does not have any information on the justification for the relative magnitude of these rebates. However, it can reasonably be anticipated that such rebates would vary widely for individual manufacturers and sponsors, and anecdotal evidence would suggest the leverage these options provide sponsors may be minimal when compared to leverage available in connection with an initial decision regarding formulary inclusion, especially since tier placement has no impact on statutory LIS cost sharing levels. Consequently, we would predict future savings for both beneficiaries and the Part D program from both increased price competition as newly approved drugs come onto the market and more immediate savings if plans were able to remove some currently covered agents from their formularies.

In addition to our concerns about increased Part D costs resulting from higher drug prices, we are also concerned that the policy potentially facilitates the overutilization of drugs within the protected classes. By limiting the ability of Part D sponsors to implement utilization management tools (for example, prior authorization or step therapy requirements) for an entire category or class, we also limit their ability to prevent the misuse or abuse of drugs that are not medically necessary. Not only can this increase Part D costs, but inappropriate use can also lead to adverse effects that can harm the beneficiary and require medical treatment that would otherwise not have been necessary. We believe the profitability of products not subject to normal price negotiations as the result of protected class status is a strong incentive for the promotion of overutilization, particularly off-label overutilization, of some of these drugs.

Given the findings in these reports and our expertise with the Part D program, we believe it is appropriate to revisit our original policy for the six drug categories and classes of clinical concern—particularly to assess whether it remains appropriate to require this additional level of protection for these categories or classes of drugs in order to ensure that Part D plans offer nondiscriminatory benefit designs and sufficient beneficiary access to medically necessary therapies. In considering the balance among beneficiary access, quality assurance, cost containment, and patient welfare in light of our existing beneficiary protections, we believe that drug categories and classes should be subject to normal formulary and price competition unless we cannot ensure clinically appropriate access (and thus non-discriminatory benefit design) to our Medicare beneficiaries in any less anticompetitive way than requiring the inclusion on all Part D formularies of all drugs in that category or class. Moreover, we believe that our consideration of how to implement section 3307 of the Affordable Care Act must take into account both the purpose of the Part D benefit and the context in which it is offered. Part D does not typically involve access to medications on an emergency basis. In cases where an emergency may arise, the Part D program has some protections to address this—for example, our long term care emergency first fill requirement requires plans to cover an emergency supply of non-formulary Part D drugs for long term care residents as part of their transition process. Moreover, the Part D benefit must be considered in light of the fact that urgently needed and emergency care is generally covered by Medicare Parts A and B.

To that end, we believe that criteria for identifying drug categories and classes of clinical concern should identify only those drug categories or classes for which access cannot be adequately ensured by beneficiary protections that otherwise apply. Consequently, as we take this opportunity to propose to codify criteria for identifying categories or classes of drugs that are of clinical concern, we believe that the requirements of section 3307 of the Affordable Care Act should be implemented taking into consideration the other protections available to beneficiaries. Otherwise, section 3307 of the Affordable Care Act would establish duplicative, and thus unnecessary, protections that would serve only to increase Part D costs—without any added benefit and with the possibility of added harm from misuse. Therefore, in considering whether additional protections continue to be needed under this section, we need to take the other beneficiary access protections into account. There are five such protections and these are formulary transparency, formulary requirements, reassignment formulary coverage notices, transition supplies and notices, and the coverage determination and appeals processes.

The first protection is our requirement for full transparency to beneficiaries. Sponsors are required to provide comprehensive formulary drug listings to the public through their own Web sites and printed materials, as well as to CMS for access through the online automated drug plan comparison tool, the Medicare Plan Finder (Plan Finder). Beneficiaries or their representatives can complete a personalized search on

Plan Finder to locate and select a Part D plan that covers their drugs. With our more than 7 years of experience with the Part D program, we are not aware of any Part D drug that is not included on at least one Part D formulary. Thus, beneficiaries who review plan formularies can select plans that cover all of their current medications.

The second type of protection is the Part D formulary requirements. Our annual formulary review and approval process includes extensive checks to ensure adequate representation of all necessary Part D drug categories or classes for the Medicare population and includes the following:

• Discrimination Review (§ 423.272(b)(2)). Formularies are reviewed to ensure inclusion of drug categories and classes that are used to treat all disease states. CMS evaluates the sufficiency of a Part D sponsor's formulary drug categories and classes in conjunction with the plan's formulary drug list to ensure that the formulary provides access to an acceptable range of Part D drug choices.

• Two Drugs Requirement (§ 423.120(b)(2)(i)). Each submitted formulary is reviewed for the inclusion of at least two distinct drugs from each of the submitted categories and classes, except as provided in § 423.120(b)(2)(ii).

• Formulary Tier Review (Medicare Prescription Drug Benefit Manual, Chapter 6, 30.2.7). The tiering structure of each formulary is reviewed to ensure that each category and class has at least one drug in a preferred tier.

• Common Medicare Drugs Review (§ 423.120(b)(2)(iii)). Formularies are reviewed for inclusion of the drugs or drug classes that are most commonly utilized by the Medicare population. We use prior years' data to identify the drugs or drug classes with the highest utilization in Medicare Part D, and use these drugs and drug classes as the basis for our review in this area. We also review formularies for the alternative dosage forms of the drugs that are most commonly utilized by the long-term care (LTC) population.

• Treatment Guidelines Review (§ 423.120(b)(2)(iii)). The World Health Organization (WHO) defines a standard treatment guideline as a systematically developed statement designed to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances (available at

http://www.who.int/medicines/technical_briefing/tbs/10-PG_Standard-Treatment-Guidelines_final-08.pdf

). We analyze formularies to determine whether appropriate access is afforded to drugs or drug classes included in widely accepted treatment guidelines. In general, although sponsors have some flexibility in determining the classification system they will use to identify categories or classes of drugs, if a treatment guideline speaks to a specific category or class of drugs, we look for representation from that drug category or class of drugs on the formulary. Moreover, if the treatment guidelines address specific drugs, we would expand this requirement to review formularies for those specific drugs, and not just the drug category or class to which they belong.

• Common Home Infusion Drugs (§ 423.120(a)(4)). We review formularies for the drugs most commonly utilized in the home infusion setting in order to help facilitate rapid access to these drugs for beneficiaries.

• Vaccines Review (§ 423.100). Each formulary submission is reviewed to ensure the formulary includes Part D vaccines.

• Insulin Supplies Review (§ 423.100). Formularies are reviewed for the supplies associated with the administration of insulin: insulin syringes, alcohol swabs, and gauze pads.

• Specialty Tier Review (§ 423.578(a)(7)). For formularies using a specialty tier, we perform an extensive review of the composition of each tier. We apply a standard outlined in the annual Call Letter to determine whether drugs placed in specialty tiers meet the relevant cost criteria.

• Quantity Limits Outlier Review (§ 423.153(b)). All formulary submissions are compared to analyze the use of quantity limit (QL) edits. Formularies that are outliers with respect to the application of QL edits are asked to remove edits or provide a reasonable justification for the applicable QL.

• Quantity Limits Amount Review (§ 423.153(b)). QL restrictions are reviewed for appropriateness. The standard for the review is generally based on the Food and Drug Administration (FDA)-approved maximum doses, when such dose limits are identified in the label.

• Restricted Access Review (§ 423.153(b)). Formularies are reviewed for use of Prior Authorization (PA) and Step Therapy (ST) edits across drug categories and classes. We decline to approve utilization management (UM) for entire drug classes, other than those considered to be best practices, for example, for erythropoietin stimulating agents (ESAs).

• Step Therapy Criteria Review (§ 423.153(b)). The ST requirements are reviewed to ensure that the algorithms are consistent with best practices.

• Prior Authorization Outlier Review (§ 423.153(b)). All formulary submissions are compared to analyze the use of PA edits. Formularies that are outliers with respect to the application of PA edits are asked to remove edits or provide a reasonable justification for such PA edits.

• Prior Authorization Criteria Review (§ 423.153(b)). We then review the criteria for focused drugs requiring PA on the initial formulary submissions. We look to existing best practices, including prerequisite drugs, current industry standards and appropriate treatment guidelines, to check that the Part D plans' use of PA is consistent with such practices. Submitted criteria are also compared to compendia and FDA-approved label indications.

• Mid-year formulary change restrictions (§ 423.120(b)(5)); Chapter 6 of the Medicare Prescription Drug Benefit Manual, 30.3.3). Except when the Food and Drug Administration deems a Part D drug unsafe or a manufacturer removes a Part D drug from the market, a Part D sponsor may not remove a covered Part D drug from its formulary, or make any adverse change in preferred or tiered cost-sharing status of a covered Part D drug, between the beginning of the annual coordinated election period described in section § 423.38(b) and 60 days after the beginning of the contract year associated with the annual coordinated election period. However, prescription drug therapies are constantly evolving, and new drug availability, medical knowledge, and opportunities for improving safety and quality in prescription drug use at a lower cost will inevitably occur over the course of the year. As recognized in regulation, these new developments may require formulary changes during the year in order to provide high-quality, affordable prescription drug coverage. To address such developments our negative formulary change policy requires that beneficiaries retain “grandfathered” coverage for the remainder of the coverage year if we permit an adverse change in the formulary status of any drug without a generic equivalent. Thus, in summary, our formulary rules both ensure that all Part D formularies contain sufficient drugs to treat all disease states in the Medicare population and protect beneficiaries from significant changes in formularies during the course of a coverage year.

The third type of beneficiary protection is the annual notice to reassigned enrollees required under section 3305 of the Affordable Care Act. Effective January 1, 2011, we provide LIS individuals who are reassigned to

another Part D plan with information on the differences under the new plan formulary, as well as information on the beneficiary's grievance and appeal rights in the new plan. Thus, any individual who has his or her plan selection decision made through our reassignment process (in order to maintain access to a $0 premium) receives detailed coverage status information for each drug for which he or she filled a prescription between January and August of the previous year. With regard to the new plan, this notice describes for each drug whether it is on the formulary, whether the brand or generic version is covered, and whether or not utilization management tools may be applied. Moreover, the notice also provides a list of other plans that are available to the beneficiary to enro

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