Source: https://www.federalregister.gov/articles/2014/01/10/2013-31497/medicare-program-contract-year-2015-policy-and-technical-changes-to-the-medicare-advantage-and-the
Timestamp: 2014-03-08 05:14:22
Document Index: 291138668

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Federal Register | Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
-2073 (157 pages)
0938-AR37
Document Number: 2013-31497
Shorter URL: https://federalregister.gov/a/2013-31497 Related Topics
Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2015 (CMS-4159-P) 1 action from September 2013 September 2013
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
C. Summary of Costs and Benefits II. Background
A. Clarifying Various Program Participation Requirements
1. Closing Cost Contract Plans to New Enrollment (§ 422.2 and § 422.503(b)(5))
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, Part D, and Cost Plan Eligibility With Fee-For-Service (FFS) Payment Exclusion Policy
11. Part D Notice of Changes (§ 423.128(g))
12. Separating the Evidence of Coverage (EOC) From the Annual Notice of Change (ANOC) (§ 422.111(a)(3) and § 423.128(a)(3))
13. Agent/Broker Compensation Requirements (§ 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
d. Analysis and Identification of the Categories or Classes of Clinical Concern
15. Medication Therapy Management Program (MTM) 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 Part D 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 (§ 423.504(b))
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 (§ 423.503)
20. Limit Stand-Alone Prescription Drug Plan Sponsors To Offering No More Than Two Plans per PDP Region (§ 423.265)
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 the Requirement That PDP Sponsors Report on the Nature and Quantity of Unused Brand and Generic Drugs (§ 423.154)
23. Medicare Coverage Gap Discount Program and Employer Group Waiver Plans (§ 423.2325)
24. Interpreting the 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 (§ 424.535)
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
(b) Criteria To Be Considered
32. Transfer of TrOOP Between PDP Sponsors Due to Enrollment Changes During the Coverage Year (§ 423.464)
33. Broadening the Release of Part D Data (§ 423.505)
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 (§ 417.1, § 417.460, § 422.74, and § 423.44)
a. Changes in Definition of Service Area for Cost Plans (§ 417.1)
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); § 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
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)
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 Good 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 Organization Extension of 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 PDP for Failure for 3 Consecutive Years To Achieve 3 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 Part D (423.120(b)(1))
7. Definition of a Part D Drug (§ 423.100)
b. Barbiturates and Benzodiazepines
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 Change (§ 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
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 Hearing 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)
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 (§ 417.460, § 422.734, and § 423.44)
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 Revisions 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 Changes to Audit and Inspection Authority (§ 422.503(d)(2) and § 423.504(d)(2))
K. ICR Related to Recovery Audit Contractor Determinations (Part 422, Subpart Z and Part 423, Subpart Z)
1. Effects of Closing Cost Contract Plans to New Enrollment
2. Effects of 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 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 Procedures for Imposing Intermediate Sanctions and Civil Money Penalties Under Parts C and D
8. Effects on Timely Access to Mail Order Services
9. Effects of 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 Medication Therapy Management Program (MTMP) Under Part D
16. Effects of Business Continuity for MA Organizations and Part D Sponsors
17. Effects of 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
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
34. Effects of Establish Authority to Directly Request Information From First Tier, Downstream, and Related Entities
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 Two-Year Prohibition When Organizations Terminate Their Contracts
47. Effects of Withdrawal of Stand Alone Prescription Drug Plan Bid Prior to Contract Execution
48. Effects of Essential Operations Test Requirement for Part D
49. Effects of 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
50. Effects of 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 Part D Drug
57. Effects of Thirty Sixth Month Coordination of Benefits (COB) Limit
58. Effects of Application and Calculation of Daily Cost-Sharing Rates
59. Effects of Technical Change To Align Regulatory Requirements for Delivery of the Standardized Pharmacy Notice
60. Effects of Special Part D Access Rules During Disasters
61. Effects of 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 Technical Change to the Restrictions on use of Information Under Part D
1. Drug Categories or Classes of Clinical Concerns and Exceptions (§ 423.102(b)(2)(v)-(vi)
2. Medication Therapy Management Program under Part D
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 (c) Use of Standardized Technology
6. Any Willing Pharmacy Standard Terms & 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 MA Organizations 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
PART 417—HEALTH MAINTENANCE ORGANIZATION, COMPETITIVE MEDICAL PLANS, AND HEALTH CARE PREPAYMENT PLANS
Subpart Z—Recovery Audit Contractor Part C Appeals Process
Table 2—Pharmaceutical Care RBRVS *—At a Glimpse
Table 3—Hypothetical Formulary Structure
Table 4—Example 1—The Beneficiary's Drug Is on Tier 2 With a Prior Authorization Requirement
Table 5—Example 2—The Beneficiary's Drug Is on Tier 4 With a Prior Authorization
Table 6—Example 3—The Beneficiary's Drug Is Not on Formulary With a Formulary Exception
Table 7— Estimated Number of Part C & D RAC Appeal Requests
Table 8—Estimated Annual Reporting/Recordkeeping Burden
Table 9—Projected Number of Individuals Disenrolled Due to Loss of Lawful Presence and Estimated Savings to the Medicare Advantage Program by Provision for Calendar Years 2015 Through 2019
Table 10—Projected Number of Individuals Disenrolled Due to Loss of Lawful Presence and Estimated Savings to the Medicare Part D Program by Provision for Calendar Years 2015 Through 2019
Table 11—Projected Number of Individuals Disenrolled Due to Incarceration and Estimated Savings to the Medicare Advantage Program by Provision for Calendar Years 2015 Through 2019
Table 12—Projected Number of Individuals Disenrolled Due to Incarceration and Estimated Savings to the Medicare Part D Program by Provision for Calendar Years 2015 through 2019
Table 13—Summary of RAC Determination Appeals Costs and Benefits
Table 14—Estimated1Aggregate Costs and Savings to the Health Care Sector by Provision for Calendar Years 2015 Through 2019
Table 15—Accounting Statement: Classifications of Estimated Costs and Transfers From Calendar Years 2015 to 2019
In commenting, please refer to file code CMS-4159-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
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.
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.
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.
5. Risk Adjustment Data Requirements (§ 422.310)
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))
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)
c. Alignment of MA, PDP, and Cost Plan Eligibility With FFS Payment Exclusion Policy
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).
a Categories or Classes of Clinical Concern
15. Medication Therapy Management Program (MTMP) Under Part D (§ 423.153(d))
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)
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)
24. Interpreting Non Interference Provision (§ 423.10)
26. Payments to PDP Plan Sponsors For Qualified Prescription Drug Coverage (§ 423.308) and Payments to Sponsors of Retiree Prescription Drug Plans (§ 423.882)
31. Improper Prescribing Practices and Patterns
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. General Rules for Overpayments (§ 422.326(a) Through (c) and § 423.360(a) Through (c))
1. Providing High Quality Health Care (§ 422.504(a)(3) and § 423.505(b)(27))
5. MA Organizations May Extend Adjudication Timeframes for Organization Determinations and Reconsiderations (§ 422.568, § 422.572, § 422.590, § 422.618, and § 422.619)
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)
3. Agent and Broker Training and Testing Requirements (§ 422.2274 and § 423.2274) 4. Deemed Approval of Marketing Materials (§ 422.2266 and § 423.2266)
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))
8. Thirty-Six-Month Coordination of Benefits (COB) Limit (§ 423.466(b))
a. Technical Changes (§ 422.641)
b. Technical Changes (§ 422.644(a) and (b))
16. Technical Changes Regarding Intermediate Sanctions and Civil Money Penalties (§ 422.756 and § 423.756)
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))
D. ICRs Related to Eligibility of Enrollment for Incarcerated Individuals
G. ICRs Related to Good Cause Processes (§ 417.460, § 422.74 and § 423.44)
J. ICRs Related to MA Organization Responsibilities in Disasters and Emergencies (§ 422.100)
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
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
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
30. Effects of Enrollment Requirements for the Prescribers of Part D Covered Drugs
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
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
50. Effects of the Requirements for Urgently Needed Services
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
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
63. Effects of the Technical Change to the Restrictions on Use of Information Under Part D
1. Drug Categories or Classes of Clinical Concerns and Exceptions
5. Access to Covered Part D Drugs: Use of Standardized Technology
6. Any Willing Pharmacy Standard Terms and Conditions
12. Business Continuity for MAOs and Part D Sponsors
DABDepartmental Appeals Board
EAJRExpedited Access to Judicial Review
EGWP Employer Group/Union-Sponsored Waiver Plan
IRMAAIncome-Related Monthly Adjustment Amount
MACMedicare Appeals Council
PBMPharmacy Benefit Manager PDEPrescription Drug Event
PFFS Private Fee For Service Plan
QICQualified Independent Contractor
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.
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.
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.
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.
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.
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 Back to Top
* 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.
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
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
Drug Categories or Classes of Clinical Concern
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).
Risk Adjustment Data Requirements
Transfer of TrOOP Between Part D Sponsors Due to Enrollment Changes during the Coverage Year
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).
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 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.
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.
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.
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.
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—
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.
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.
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.
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.
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.
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 need1
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.
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.
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).
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 becomin