Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
Federal RegisterMay 23, 2014
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 417, 422, 423, and 424
[CMS-4159-F]
RIN 0938-AR37
Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
AGENCY:
Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION:
Final rule.
SUMMARY:
The final rule will revise the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement statutory requirements; improve program efficiencies; and clarify program requirements. The final rule also includes several provisions designed to improve payment accuracy.
DATES:
Effective Dates:
These regulations are effective on July 22, 2014 except for the amendment in instruction 27 to § 423.100, the amendment in instruction 30 to § 423.501, and the amendment in instruction 34 to § 423.505, which are effective on January 1, 2016.
Applicability Dates:
In the
SUPPLEMENTARY INFORMATION
section of this final rule, we provide a table (Table 1) which lists key changes in this final rule that have an applicability date other than the effective date of this final rule.
FOR FURTHER INFORMATION CONTACT:
Christopher McClintick, (410) 786-4682, Part C issues.
Marie Manteuffel, (410) 786-3447, Part D issues.
Kristy Nishimoto, (206) 615-2367, Part C and D enrollment and appeals issues.
Whitney Johnson, (410) 786-0490, Part C and D payment issues.
Joscelyn Lissone, (410) 786-5116, Part C and D compliance issues.
Frank Whelan, (410) 786 1302, Part D improper prescribing issues.
SUPPLEMENTARY INFORMATION:
Table 1 lists key changes that have an applicability date other than 60 days after the date of publication of this final rule. The applicability dates are discussed in the preamble for each of these items.
Table 1—Applicability Date of Key Provisions Other Than 60 Days After the Date of Publication of the Final Rule
Preamble section
Section title
Applicability date
III.A.4
Reducing the Burden of the Compliance Program Training Requirements (§§ 422.503(b)(4)(vi)(C) and § 423.504(b)(4)(vi)(C))
01/01/2016
III.A.7
Agent/Broker Compensation Requirements (§§ 422.2274 and 423.2274)
01/01/2015
III.A.20
Enrollment Requirements for the Prescribers of Part D Covered Drugs (§ 423.120(c)(6))
06/01/2015
III.A.24
Eligibility of Enrollment for Incarcerated Individuals (§§ 417.1, 417.460(b)(2)(i), 417.460(f)(1)(i)(A) through (C), 422.74(d)(4)(i)(A), 422.74(d)(4)(v), 423.44(d)(5)(iii) and (iv))
01/01/2015
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
1. Modifying the Agent/Broker Requirements, Specifically Agent/Broker Compensation
2. Drug Categories or Classes of Clinical Concern
3. Improving Payment Accuracy—Implementing Overpayment Provisions of Section 1128J (d) of the Social Security Act (§§ 422.326 and 423.360).
4. Risk Adjustment Data Requirements (§ 422.310)
C. Summary of Costs and Benefits
II. Background
A. General Overview and Regulatory History
B. Issuance of a Notice of Proposed Rulemaking
C. Public Comments Received in Response to the CY 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs Proposed Rule
D. Provisions Not Finalized in this Final Rule
III. Provisions of the Proposed Regulations
A. Clarifying Various Program Participation Requirements
1. Closing Cost Contract Plans to New Enrollment (§§ 422.2 and 22.503)
2. Authority to Impose Intermediate Sanctions and Civil Money Penalties (§§ 422.752, 423.752, 422.760 and 423.760)
3. Contract Termination Notification Requirements and Contract Termination Basis (§§ 422.510 and 423.509)
4. Reducing the Burden of the Compliance Program Training Requirements (§§ 422.503(b)(4)(vi)(C) and 423.504(b)(4)(vi)(C))
5. Procedures for Imposing Intermediate Sanctions and Civil Money Penalties Under Parts C and D (§§ 422.756 and 423.756)
6. Timely Access to Mail Order Services (§ 423.120)
7. Agent/Broker Requirements, Particularly Compensation (§§ 422.2274 and 423.2274)
8. Drug Categories or Classes of Clinical Concern (§ 423.120(b)(2)(v))
9. Medication Therapy Management Program (MTMP) under Part D (§ 423.153(d))
a. Multiple Chronic Diseases
b. Multiple Part D Drugs
c. Annual Cost Threshold
10. 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))
11. 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))
12. Limit Parent Organizations to One Prescription Drug Plan (PDP) Sponsor Contract Per PDP Region (§ 423.503)
13. Limit Stand-Alone Prescription Drug Plan Sponsors to Offering No More Than Two Plans Per PDP Region (§ 423.265)
14. Applicable Cost-Sharing for Transition Supplies: Transition Process Under Part D (§ 423.120(b)(3))
15. Interpreting the Non Interference Provision (§ 423.10)
16. Pharmacy Price Concessions in Negotiated Prices (§ 423.100)
17. Preferred Cost Sharing (§§ 423.100 and 423.120)
18. Prescription Drug Pricing Standards and Maximum Allowable Cost (§ 423.505(b)(21))
19. Any Willing Pharmacy Standard Terms & Conditions (§ 423.120(a)(8))
20. Enrollment Requirements for Prescribers of Part D Covered Drugs (§ 423.120(c)(5) and (6))
21. Improper Prescribing Practices (§§ 424.530 and 424.535)
a. Background and Program Integrity Concerns
b. Drug Enforcement Administration (DEA) Certification of Registration
c. Patterns or Practices of Prescribing
22. Broadening the Release of Part D Data (§ 423.505)
23. Establish Authority to Directly Request Information From First Tier, Downstream, and Related Entities (§§ 422.504(i)(2)(i) and 423.505(i)(2)(i))
24. Eligibility of Enrollment for Incarcerated Individuals (§§ 417.1, 417.422, 417.460, 422.74, and 423.44)
a. Changes in Definition of Service Area for Cost Plans (§§ 417.1 and 417.422(b))
b. Involuntary Disenrollment for Incarcerated Individuals Enrolled in MA, PDP and cost plans (§§ 417.460, 422.74, and 423.44)
25. Rewards and Incentives Program Regulations for Part C Enrollees (§ 422.134)
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(b) through (c); § 423.360(b) through (c))
c. Look-back Period for Reporting and Returning Overpayments
2. Risk Adjustment Data Requirements (§ 422.310)
3. RADV Appeals
a. Background
b. RADV Definitions
c. Publication of RADV Methodology
d. Proposal to Update RADV Appeals Terminology (§ 422.311)
e. Proposal to Simplify the RADV Appeals Process
(1) Issues Eligible for RADV Appeal
(2) Issues Not Eligible for RADV Appeals
(3) Manner and Timing of a Request for RADV Appeal
(4) Reconsideration Stage
(5) Hearing Stage
(6) CMS Administrator Review Stage
f. Proposal to Expand Scope of RADV Audits
g. Proposal to Clarify the RADV Medical Record Review Determination Appeal Burden of Proof Standard
h. Proposal to Change RADV Audit Compliance Date
4. Recovery Audit Contractor (RAC) Determination Appeals (Proposed Part 422 Subpart Z and Part 423 Subpart Z)
a. Background
b. Proposed RAC Appeals Process
(1) Reconsiderations (§§ 422.2605 and 423.2605)
(2) Hearing Official Determinations (§§ 422.2610 and 423.2610)
(3) Administrator Review (§§ 422.2615 and 423.2615)
C. Implementing Other Technical Changes
1. Definition of a Part D Drug (§ 423.100)
a. Combination Products
b. Barbiturates and Benzodiazepines
c. Medical Foods
2. Special Part D Access Rules During Disasters or Emergencies (§ 423.126)
3. 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))
4. Technical Changes Regarding Intermediate Sanctions and Civil Money Penalties (§§ 422.756 and 423.756)
a. Technical Changes to Intermediate Sanctions Notice Receipt Provisions (§§ 422.756(a)(2) and 423.756(a)(2))
b. Cross-reference Changes (§§ 422.756(b)(4) and 423.756(b)(4))
c. Technical Changes (§§ 422.756(d) and 423.756(d))
d. Technical Changes to Align the Civil Money Penalty Provision with the Authorizing Statute (§§ 422.760(a)(3) and 423.760(a)(3))
e. Technical Changes to Align the Civil Money Penalty Notice Receipt Provisions (§§ 422.1020(a)(2), 423.1020(a)(2), 422.1016(b)(1), and 423.1016(b)(1))
IV. Collection of Information Requirements
A. ICRs Related to Improper Prescribing Practices and Patterns (§ 424.535(a)(13) and (14))
B. 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))
C. ICRs Related to Eligibility of Enrollment for Incarcerated Individuals (§§ 417.460, 422.74, and 423.44)
D. ICRs Related to Rewards and Incentives Program Regulations for Part C Enrollees (§ 422.134)
E. ICR Related to Recovery Audit Contractor Determinations (Part 422, Subpart Z and Part 423, Subpart Z)
V. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Anticipated Effects
1. Effects of Closing Cost Contract Plans to New Enrollment
2. Effects of the Authority to Impose Intermediate Sanctions and Civil Money Penalties
3. Effects of Contract Termination Notification Requirements and Contract Termination Basis
4. Effects of Reducing the Burden of the Compliance Program Training Requirements
5. Effects of the Procedures for Imposing Intermediate Sanctions and Civil Money Penalties under Parts C and D
6. Effects of Timely Access to Mail Order Services
7. Effects of the Modification of the Agent/Broker Compensation Requirements
8. Effects of Drug Categories or Classes of Clinical Concern
9. Effects of the Medication Therapy Management Program (MTMP) under Part D
10. 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
11. 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
12. Effects of Limit Parent Organizations to One Prescription Drug Plan (PDP) Sponsor Contract per PDP Region
13. Effects of Limit Stand-Alone Prescription Drug Plan Sponsors to Offering No More Than Two Plans per PDP Region
14. Effects of Applicable Cost-Sharing for Transition Supplies: Transition Process Under Part D
15. Effects of Interpreting the Non-Interference Provision
16. Effects of Pharmacy Price Concessions in Negotiated Prices
17. Effects of Preferred Cost Sharing
18. Effects of Maximum Allowable Cost Pricing Standard
19. Effects of Any Willing Pharmacy Standard Terms & Conditions
20. Effects of Enrollment Requirements for Prescribers of Part D Covered Drugs
21. Effects of Improper Prescribing Practices and Patterns
22. Effects of Broadening the Release of Part D Data
23. Effects of Establish Authority to Directly Request Information From First Tier, Downstream, and Related Entities
24. Effects of Eligibility of Enrollment for Incarcerated Individuals
25. Effects of Rewards and Incentives Program Regulations for Part C Enrollees
26. Effects of Improving Payment Accuracy: Reporting Overpayments, RADV Appeals, and LIS Cost Sharing
27. Effects of Part C and Part D RAC Determination Appeals
28. Effects of the Technical Changes to the Definition of a Part D Drug
29. Effects of the Special Part D Access Rules During Disasters
30. Effects of Termination of a Contract under Parts C and D
31. Effects of Technical Changes Regarding Intermediate Sanctions and Civil Money Penalties
D. Expected Benefits
1. Drug Categories or Classes of Clinical Concern
2. Medication Therapy Management Program under Part D
E. Alternatives Considered
1. Modifying the Agent/Broker Compensation Requirements
2. Any Willing Pharmacy Standard Terms and Conditions
3. Pharmacy Price Concessions in Negotiated Prices
4. Special Part D Access Rules During Disasters or Emergencies
5. Drug Categories or Classes of Clinical Concern
6. Medication Therapy Management Program (MTM) Under Part D
7. Requirement for Applicants or their Contracted First Tier, Downstream, or Related Entities to have Experience in the Part D Program Providing Key Part D Functions
F. Accounting Statement and Table
G. Conclusion
Regulations Text
Acronyms
ADS Automatic Dispensing System
AEP Annual Enrollment Period
AHFS American Hospital Formulary Service
AHFS-DI American Hospital Formulary Service-Drug Information
AHRQ Agency for Health Care Research and Quality
ALJ Administrative Law Judge
ANOC Annual Notice of Change
AO Accrediting Organization
AOR Appointment of Representative
BBA Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA [Medicare, Medicaid and State Child Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
BIPA [Medicare, Medicaid, and SCHIP] Benefits Improvement Protection Act of 2000 (Pub. L. 106-554)
BLA Biologics License Application
CAHPS Consumer Assessment Health Providers Survey
CAP Corrective Action Plan
CCIP Chronic Care Improvement Program
CC/MCC Complication/Comorbidity and Major Complication/Comorbidity
CCS Certified Coding Specialist
CDC Centers for Disease Control
CHIP Children's Health Insurance Programs
CMP Civil Money Penalty
CMR Comprehensive Medical Review
CMS Centers for Medicare & Medicaid Services
CMS-HCC CMS Hierarchal Condition Category
CTM Complaints Tracking Module
COB Coordination of Benefits
CORF Comprehensive Outpatient Rehabilitation Facility
CPC Certified Professional Coder
CY Calendar year
DAB Departmental Appeals Board
DEA Drug Enforcement Administration
DIR Direct and Indirect Remuneration
DME Durable Medical Equipment
DMEPOS Durable Medical Equipment, Prosthetic, Orthotics, and Supplies
D-SNPs Dual Eligible SNPs
DOL U.S. Department of Labor
DUA Data Use Agreement
DUM Drug Utilization Management
EAJR Expedited Access to Judicial Review
EGWP Employer Group/Union-Sponsored Waiver Plan
EOB Explanation of Benefits
EOC Evidence of Coverage
ESRD End-Stage Renal Disease
FACA Federal Advisory Committee Act
FDA Food and Drug Administration
FEHBP Federal Employees Health Benefits Plan
FFS Fee-For-Service
FIDE Fully-integrated Dual Eligible
FIDE SNPs Fully-integrated Dual Eligible Special Needs Plans
FMV Fair Market Value
FY Fiscal year
GAO Government Accountability Office
HAC Hospital-Acquired Conditions
HCPP Health Care Prepayment Plans
HEDIS HealthCare Effectiveness Data and Information Set
HHS [U.S. Department of] Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191)
HMO Health Maintenance Organization
HOS Health Outcome Survey
HPMS Health Plan Management System
ICL Initial Coverage Limit
ICR Information Collection Requirement
ID Identification
IVC Initial Validation Contractor
LCD Local Coverage Determination
LEP Late Enrollment Penalty
LIS Low Income Subsidy
LPPO Local Preferred Provider Organization
LTC Long Term Care
MA Medicare Advantage
MAAA Member of the American Academy of Actuaries
MA-PD Medicare Advantage-Prescription Drug Plan
MIPPA Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275)
MOC Medicare Options Compare
MOOP Maximum Out-of-Pocket
MPDPF Medicare Prescription Drug Plan Finder
MMA Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)
MS-DRG Medicare Severity Diagnosis Related Group
MSA Metropolitan Statistical Area
MSAs Medical Savings Accounts
MSP Medicare Secondary Payer
MTM Medication Therapy Management
MTMP Medication Therapy Management Program
NAIC National Association of Insurance Commissioners
NCD National Coverage Determination
NCPDP National Council for Prescription Drug Programs
NCQA National Committee for Quality Assurance
NDA New Drug Application
NDC National Drug Code
NGC National Guideline Clearinghouse
NIH National Institutes of Health
NOMNC Notice of Medicare Non-Coverage
NPI National Provider Identifier
NWS National Weather Service
OIG Office of Inspector General
OMB Office of Management and Budget
OPM Office of Personnel Management
OTC Over the Counter
Part C Medicare Advantage
Part D Medicare Prescription Drug Benefit Program
PBM Pharmacy Benefit Manager
PDE Prescription Drug Event
PDP Prescription Drug Plan
PFFS Private Fee For Service Plan
POA Present on Admission (Indicator)
POS Point-of-Sale
PPO Preferred Provider Organization
PPS Prospective Payment System
P&T Pharmacy & Therapeutics
QIC Qualified Independent Contractor
QIO Quality Improvement Organization
QRS Quality Review Study
PACE Programs of All Inclusive Care for the Elderly
RADV Risk Adjustment Data Validation
RAPS Risk Adjustment Payment System
RPPO Regional Preferred Provider Organization
SCORM Sharable Content Object Reference Model
SEP Special Election Period
SHIP State Health Insurance Assistance Programs
SNF Skilled Nursing Facility
SNP Special Needs Plan
SPAP State Pharmaceutical Assistance Programs
SSA Social Security Administration
SSI Supplemental Security Income
T&C Terms and Conditions
TPA Third Party Administrator
TrOOP True Out-Of-Pocket
U&C Usual and Customary
UPIN Uniform Provider Identification Number
USP U.S. Pharmacopoeia
I. Executive Summary
A. Purpose
The purpose of this final 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. This final rule is necessary to—(1) clarify various program participation requirements; (2) improve payment accuracy; and (3) make other clarifications and technical changes.
B. Summary of the Major Provisions
1. Modifying the Agent/Broker Requirements, Specifically Agent/Broker Compensation
The former regulatory compensation structure was comprised of a 6-year cycle that ended December 31, 2013. Under that structure, MA organizations and Part D sponsors provided an initial compensation payment to independent agents for new enrollees (Year 1), and paid a renewal rate (equal to 50 percent of the initial year compensation) for Years 2 through 6. MA organizations and Part D sponsors had the option to pay the 50 percent renewal rate for CY2014 (year 1). This compensation structure proved to be complicated to implement and monitor, and also created an incentive for agents to move beneficiaries as long as the fair market value (FMV) continued to increase each year. To resolve these issues, we proposed to revise the compensation structure. Under our proposal, MA organizations and Part D sponsors would continue to have the discretion to decide, on an annual basis, whether or not to use independent agents. Also, for new enrollments, MA organizations and Part D sponsors could determine what their initial rate would be, up to the CMS designated FMV amount. For renewals in Year 2 and subsequent years, with no end date, the MA organization or Part D sponsor could pay up to 35 percent of the current FMV amount for that year. We believed 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 was appropriate based on a couple of factors. First, we believed 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 was 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 proposed to amend the training and testing requirements as well as setting limits on referral fees ($100) for agents and brokers.
We received more than 140 comments from agents, health plans, and trade associations opposing the 35 percent renewal rate, and instead suggesting that CMS maintain the 50 percent renewal rate. A number of commenters expressed concerns that the proposed reduction in compensation would represent a significant decrease from the current compensation limit, and a rate set at 50 percent of FMV would be in line with industry standard. They noted that the higher compensation amount would be particularly important for stand-alone prescription drug plans, as 35 percent would be insufficient to cover an agent's costs associated with the renewal transaction and could discourage agents from assisting in the annual evaluation of a Medicare beneficiary's options. Commenters also stated that, compared to current practice, the proposed 35 percent renewal rate is a reduction since a number of MA plans began offering a renewal rate of 50 percent for 10 years or more at the end of the 6-year cycle (2013). The majority of commenters also stated that agents play an important role in educating beneficiaries about Medicare and the proposed reduction in the renewal rate could reduce the level and quality of services provided to beneficiaries, thereby resulting in less information sharing and poorer plan choices by beneficiaries. Many commenters also stated that agents spend a significant amount of time in training, preparing, and educating beneficiaries and that the compensation is already low relative to the hours spent. Some commenters also expressed concern that the lower compensation rate would discourage new agents from entering the MA market. Many agents stated they would have to stop selling MA products and instead sell other more profitable products. No plans strongly supported the 35 percent renewal rate. Therefore, we are modifying the compensation renewal rate from up to 35 percent to up to 50 percent. These changes will be applicable for enrollments effective January 2015. Because the proposed rate is similar to previous regulatory requirements, present CMS guidance, and industry practice, we believe this implementation timeframe is reasonable and appropriate. We are not finalizing the proposed changes to agent and broker training and testing at this time. We are finalizing limits on referral fees for agents as proposed.
2. Drug Categories or Classes of Clinical Concern
We are not finalizing any new criteria and will maintain the existing six protected classes.
3. Improving Payment Accuracy—Implementing Overpayment Provisions of Section 1128J(d) of the Social Security Act (§§ 422.326 and 423.360)
These proposed regulatory provisions codify the Affordable Care Act requirement establishing section 1128J(d) of the Act that MA organizations and Part D sponsors report and return identified Medicare overpayments.
We proposed to adopt the statutory definition of overpayment for both Part C and Part D, which means any funds that an MA organization or Part D sponsor has received or retained under Title XVIII of the Act to which the MA organization or Part D sponsor, after applicable reconciliation, is not entitled under such title. To reflect the unique structure of Part C and Part D payments to plan sponsors, we also propose to define two terms included in the statutory definition of overpayments: “funds” and “applicable reconciliation.” We proposed to define funds as payments an MA organization or Part D sponsor has received that are based on data that these organizations submitted to CMS for payment purposes. For Part C we proposed that applicable reconciliation occurs on the annual final risk adjustment data submission deadline. For Part D, we proposed that applicable reconciliation occurs on the date that is the later of either the annual deadline for submitting prescription drug event (PDE) data for the annual Part D payment reconciliations referred to in § 423.343(c) and (d) or the annual deadline for submitting DIR data.
In addition, we proposed to state in regulation that an MA organization or Part D sponsor has identified an overpayment if it has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the existence of the overpayment. An MA organization or Part D sponsor must report and return any identified overpayment it received no later than 60 days after the date on which it identified it received an overpayment. The MA organization or Part D sponsor must notify CMS, using a notification process determined by CMS, of the amount and reason for the overpayment. Finally, we proposed a look-back period with an exception for overpayments resulting from fraud, whereby MA organizations and Part D sponsors would be held accountable for reporting overpayments within the 6 most recent completed payment years for which the applicable reconciliation has been completed.
We received approximately 30 comments from organizations and individuals. Generally, commenters supported establishing separate applicable reconciliation dates for Part C and Part D. Many commenters questioned when the 60-day period for reporting and returning begins, and what activities constitute reporting and returning an overpayment to CMS, including questions about estimating an amount of overpayment. A number of commenters also requested to clarify the standards for “identifying” an overpayment, including questions about the meaning of reasonable diligence. Finally, a few commenters recommended that we impose the same limitation on the look-back period for all overpayments, even those relating to fraud.
We are finalizing the provisions at §§ 422.326 and 423.360, with the following modifications. First, we add at the end of paragraph § 422.326(d) the phrase “unless otherwise directed by CMS for the purpose of § 422.311.” Also, to increase clarity we revise §§ 422.326(c) and 423.360(c) regarding identified overpayments. Finally, we strike the following sentence in the proposed paragraphs on the 6-year look-back period: “Overpayments resulting from fraud are not subject to this limitation of the lookback period.”
4. Risk Adjustment Data Requirements
We proposed several amendments to § 422.310 to strengthen existing regulations related to the accuracy of
risk adjustment data, including: (1) A requirement that medical record reviews, if used, be designed to determine the accuracy of diagnoses submitted under §§ 422.308(c)(1) and 422.310(g)(2); (2) a revision in the deadlines for submission of risk adjustment data; and (3) a limitation on the type and purpose of late data submissions. We also proposed a restructuring of subparagraph (g)(2) as part of the revisions. We received approximately 25 comments from organizations and individuals regarding these proposals; many of the comments were concerned and critical of the proposals, highlighting vagueness and the potential for operational instability. For reasons discussed in more detail below in section III.B.2 of the preamble, we are not finalizing the proposed amendment regarding the scope of medical reviews and we are not finalizing at this time the proposal to change the date for final risk adjustment data submission. We are finalizing as proposed the restructuring of §§ 422.310(g)(2) and the 422.310(g)(2)(ii) provision to prohibit submission of diagnoses for additional payment after the final risk adjustment data submission deadline.
C. Summary of Costs and Benefits
Table 2—Summary of Costs and Benefits
Provision description
Total costs
Transfers
Modifying the agent/broker requirements, specifically agent/broker compensation
N/A
N/A
Improving Payment Accuracy
N/A
N/A
Eligibility of Enrollment for Incarcerated Individuals
We estimate that this change could save the MA program up to $27 million in 2015, increasing to $103 million in 2024 (total of $650 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 $153 million in 2024 (total of $965 million over this period).
II. Background
A. General Overview and Regulatory History
The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) created a new “Part C” in the Medicare statute (sections 1851 through 1859 of the Social Security Act (the Act)) which established what is now known as the Medicare Advantage (MA) program. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), enacted on December 8, 2003, added a new “Part D” to the Medicare statute (sections 1860D-1 through 42 of the Act) entitled the Medicare Prescription Drug Benefit Program (PDP), and made significant changes to the existing Part C program, which it named the Medicare Advantage (MA) Program. The MMA directed that important aspects of the Part D program be similar to, and coordinated with, regulations for the MA program. Generally, the provisions enacted in the MMA took effect January 1, 2006. The final rules implementing the MMA for the MA and Part D prescription drug programs appeared in the
Federal Register
on January 28, 2005 (70 FR 4588 through 4741 and 70 FR 4194 through 4585, respectively).
Since the inception of both Parts C and D, we have periodically revised our regulations either to implement statutory directives or to incorporate knowledge obtained through experience with both programs. For instance, in the September 18, 2008 and January 12, 2009
Federal Register
(73 FR 54226 and 74 FR 1494, respectively), we issued Part C and D regulations to implement provisions in the Medicare Improvement for Patients and Providers Act (MIPPA) (Pub. L. 110-275). We promulgated a separate interim final rule in January 16, 2009 (74 FR 2881) to address MIPPA provisions related to Part D plan formularies. In the final rule that appeared in the April 15, 2010
Federal Register
(75 FR 19678), we made changes to the Part C and D regulations which strengthened various program participation and exit requirements; strengthened beneficiary protections; ensured that plan offerings to beneficiaries included meaningful differences; improved plan payment rules and processes; improved data collection for oversight and quality assessment; implemented new policies; and clarified existing program policy.
In a final rule that appeared in the April 15, 2011
Federal Register
(76 FR 21432), we continued our process of implementing improvements in policy consistent with those included in the April 2010 final rule, and also implemented changes to the Part C and Part D programs made by recent legislative changes. The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted on March 23, 2010, as passed by the Senate on December 24, 2009, and the House on March 21, 2010. The Health Care and Education Reconciliation Act (Pub. L. 111-152), which was enacted on March 30, 2010, modified a number of Medicare provisions in Pub. L. 111-148 and added several new provisions. The Patient Protection and Affordable Care Act (Pub. L. 111-148) and the Health Care and Education Reconciliation Act (Pub. L. 111-152) are collectively referred to as the Affordable Care Act. The Affordable Care Act included significant reforms to both the private health insurance industry and the Medicare and Medicaid programs. Provisions in the Affordable Care Act concerning the Part C and D programs largely focused on beneficiary protections, MA payments, and simplification of MA and Part D program processes. These provisions affected implementation of our policies regarding beneficiary cost-sharing, assessing bids for meaningful differences, and ensuring that cost-sharing structures in a plan are transparent to beneficiaries and not excessive. In the April 2011 final rule, we revised regulations on a variety of issues based on the Affordable Care Act and our experience in administering the MA and Part D programs. The rule covered areas such as marketing, including agent/broker training; payments to MA organizations based on quality ratings; standards for determining if organizations are fiscally sound; low income subsidy policy under the Part D program; payment rules for non-contract health care providers; extending current network adequacy standards to Medicare medical savings account (MSA) plans that employ a network of providers; establishing limits on out-of-pocket expenses for MA enrollees; and several revisions to the special needs plan requirements, including changes concerning SNP approvals.
In a final rule that appeared in the April 12, 2012
Federal Register
(77 FR 22072 through 22175), we made several changes to the Part C and Part D
programs required by statute, including the Affordable Care Act, as well as made improvements to both programs through modifications reflecting experience we have obtained administering the Part C and Part D programs. Key provisions of that final rule implemented changes closing the Part D coverage gap, or “donut hole,” for Medicare beneficiaries who do not already receive low-income subsidies from us by establishing the Medicare Coverage Gap Discount Program. We also included provisions providing new benefit flexibility for fully-integrated dual eligible special needs plans, clarifying coverage of durable medical equipment, and combatting possible fraudulent activity by requiring Part D sponsors to include an active and valid prescriber National Provider Identifier on prescription drug event records.
B. Issuance of a Notice of Proposed Rulemaking
In the proposed rule titled “Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs,” which appeared in the January 10, 2014
Federal Register
(79 FR 1918), we proposed to revise the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement statutory requirements; strengthen beneficiary protections; exclude plans that perform poorly; improve program efficiencies; and clarify program requirements. The proposed rule also included several provisions designed to improve payment accuracy.
C. Public Comments Received in Response to the CY 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs Proposed Rule
We received approximately 7,600 timely pieces of correspondence containing multiple comments on the CY 2014 proposed rule. While we are finalizing several of the provisions from the proposed rule, there are a number of provisions from the proposed rule (for example, enrollment eligibility criteria for individuals not lawfully present in the United States) that we intend to address later and a few which we do not intend to finalize. We also note that some of the public comments were outside of the scope of the proposed rule. These out-of-scope public comments are not addressed in this final rule. Summaries of the public comments that are within the scope of the proposed rule and our responses to those public comments are set forth in the various sections of this final rule under the appropriate heading. However, we note that in this final rule we are not addressing comments received with respect to the provisions of the proposed rule that we are not finalizing at this time. Rather, we will address them at a later time, in a subsequent rulemaking document, as appropriate.
D. Provisions Not Finalized in This Final Rule
As noted previously, some of the provisions of the proposed rule will be addressed later and, therefore, are not being finalized in this rule. Table 3 lists the provisions that were proposed but are not addressed at this time. We note that several provisions that were proposed are not being finalized in this rule and are effectively being withdrawn; those provisions are not listed in Table 3.
Table 3—Provisions Not Finalized at This Time
Proposed rule section
Topic
Clarifying Various Program Participation Requirements
III.A.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)).
III.A.6
Changes to Audit and Inspection Authority (§ 422.503(d)(2) and § 423.504(d)(2)).
III.A.9
Collections of Premiums and Cost Sharing (§ 423.294).
III.A.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).
III.A.11
Part D Notice of Changes (§ 423.128(g)).
III.A.12
Separating the Annual Notice of Change (ANOC) from the Evidence of Coverage (EOC) (§ 422.111(a)(3) and § 423.128(a)(3)).
III.A.14
Exceptions to Drug Categories or Classes of Clinical Concern (§ 423.120(b)(2)(vi)).
III.A.15
Medication Therapy Management Program (MTMP) under Part D (§ 423.153(d)(1)(v)(A))—outreach strategies.
III.A.16
Business Continuity for MA Organizations and PDP Sponsors (§ 422.504(o) and § 423.505(p)).
III.A.21
Efficient Dispensing in Long Term Care Facilities and Other Changes (§ 423.154).
III.A.23
Medicare Coverage Gap Discount Program and Employer Group Waiver Plans (§ 423.2325).
III.A.26
Payments to PDP Plan Sponsors For Qualified Prescription Drug Coverage (§ 423.308) and Payments to Sponsors of Retiree Prescription Drug Plans (§ 423.882).
III.A.32
Transfer of TrOOP Between PDP Sponsors Due to Enrollment Changes during the Coverage Year (§ 423.464).
III.A.37
Expand Quality Improvement Program Regulations (§ 422.152).
III.A.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).
Improving Payment Accuracy
III.B.2
Determination of Payments (§ 423.329).
III.B.3
Reopening (§ 423.346).
III.B.4
Payment Appeals (§ 423.350).
III.B.5
Payment Processes for Part D Sponsors (§ 423.2320).
III.B.6
Risk adjustment data requirements—proposal regarding annual deadline for MAO submission of final risk adjustment data (§ 422.310(g)(2)(ii)).
Strengthening Beneficiary Protections
III.C.1
Providing High Quality Health Care (§ 422.504(a)(3) and § 423.505(b)(27)).
III.C.2
MA-PD Coordination Requirements for Drugs Covered Under Parts A, B, and D (§ 422.112).
III.C.3
Good Cause Processes (§ 417.460, § 422.74 and § 423.44).
III.C.4
Definition of Organization Determination (§ 422.566).
III.C.5
MA Organizations May Extend Adjudication Timeframes for Organization Determinations and Reconsiderations (§ 422.568, § 422.572, § 422.590, § 422.618, and § 422.619).
Strengthening Our Ability to Distinguish Stronger Applicants for Part C and D Program Participation and to Remove Consistently Poor Performers
III.D.1
Two-Year Prohibition When Organizations Terminate Their Contracts (§§ 422.502, 422.503, 422.506, 422.508, and 422.512).
III.D.2
Withdrawal of Stand-Alone Prescription Drug Plan Bid Prior to Contract Execution (§ 423.503).
III.D.3
Essential Operations Test Requirement for Part D (§§ 423.503(a) and (c), 423.504(b)(10), 423.505(b)(28), and 423.509).
III.D.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).
Implementing Other Technical Changes
III.E.1
Requirements for Urgently Needed Services (§ 422.113).
III.E.2
Skilled Nursing Facility Stays (§§ 422.101 and 422.102).
III.E.3
Agent and Broker Training and Testing Requirements (§§ 422.2274 and 423.2274).
III.E.4
Deemed Approval of Marketing Materials (§ 422.2266 and § 423.2266).
III.E.5
Cross-Reference Change in the Part C Disclosure Requirements (§ 422.111).
III.E.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)).
III.E.8
Thirty-Six-Month Coordination of Benefits (COB) Limit (§ 423.466(b)).
III.E.9
Application and Calculation of Daily Cost-Sharing Rates (§ 423.153).
III.E.10
Technical Change to Align Regulatory Requirements for Delivery of the Standardized Pharmacy Notice (§ 423.562).
III.E.12
MA Organization Responsibilities in Disasters and Emergencies (§ 422.100).
III.E.14
Technical Changes to Align Part C and Part D Contract Determination Appeal Provisions (§§ 422.641 and 422.644).
III.E.15
Technical Changes to Align Parts C and D Appeal Provisions (§§ 422.660 and 423.650).
III.E.17
Technical Change to the Restrictions on use of Information under Part D (§ 423.322).
III. Provisions of the Proposed Regulations and Analysis of and Responses to Public Comments
A. Clarifying Various Program Participation Requirements
1. Closing Cost Contract Plans to New Enrollment (§ 422.503(b)(4))
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 proposed to revise paragraph § 422.503(b)(4)(vi)(G)(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 proposed to add the definition of “parent organization” to § 422.2 of the MA program definitions, specifying that, “Parent organization means a legal entity that owns one or more other subsidiary legal entities.” 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. We requested comments on whether a parent organization with less than a 100 percent interest in a subsidiary legal entity should trigger the prohibition we proposed with the amendment at § 422.503(b)(4).
During the public notice and comment process, a handful of commenters provided their input on our proposal. Some of the respondents included multiple comments. The comments and our responses follow.
Comment:
A commenter supported the proposal, stating that it would prevent possible shifting of sicker enrollees to cost plans and should result in Medicare savings.
Response:
We thank the commenter for the support.
Comment:
A commenter stated that there is no evidence of complaints about the current situation and thus no change in current policy is necessary.
Response:
The intention of our initial rule was to ensure that situations not arise in which an entity was able to move an enrollee from one of its plans to another plan in the same area based on financial or other reasons that may not be in the enrollee's best interest. The current regulations limit this possibility to some extent, but, without the proposed changes, would leave open the possibility that legal entities controlled by a shared parent organization could move enrollees from one plan to another, based on something other than the enrollee's best interest.
Comment:
A commenter stated that risk-adjusted payments for MA plans eliminate any incentive for an entity to move sicker enrollees from an MA plan to a cost plan.
Response:
While risk adjusted payments do help to account for costs associated with sicker enrollees, it may still be advantageous for an organization to move an enrollee from an MA plan to a cost plan. Even with risk adjustment, there are other reasons an organization might want to move enrollees from one plan to another to include enrollment and other interests based on the organization's business model.
Comment:
A commenter stated that, because cost plan cost-sharing and premiums must be equal to the actuarial value of Medicare fee-for-service cost-sharing, cost plan enrollees with high health care needs would have high relative costs resulting in higher premiums for the cost plan, thus removing any incentive for moving sicker enrollees from an entity's MA plan to the cost plan.
Response:
MA plans also have constraints with respect to cost-sharing that affect premiums, and out-of-pocket payments by enrollees. We believe, as a result, that any difference in cost plan and MA premiums or cost-sharing is negligible and does little to remove the incentives for organizations to move enrollees from one of their plans to another.
Comment:
A couple of commenters requested that, at minimum, the provision not be applied to entities that have both a cost plan and dual eligible special needs plan (D-SNP). One of the commenters states that: (1) cost plans would likely have a premium and cost sharing that would make it unattractive for dual eligibles; and (2) the regulation could eliminate D-SNPs that “participate in longstanding dual eligible integrated plans,” and thus the proposal “could have the effect of hurting a major initiative of the Administration.”
Response:
As we have addressed elsewhere in the comments on this issue, we do not believe that any premium and cost-sharing differences in cost plans and MA plans necessarily reduce the incentives an organization may have for moving an individual from one of its plans to another. We believe this is also the case for D-SNPs and, that in the case of D-SNPs, which are frequently made up of enrollees that are sicker and frailer than the general Medicare population, there may be even greater incentive to move these enrollees to a cost contract plan.
Comment:
A commenter requested that we not finalize the proposal because cost plan enrollees will already be subject to dwindling cost plan enrollment options as a result of the cost plan competition statute. The commenter stated that if we do finalize the proposal, we should grant an exception and not require cost plans affected by the cost plan competition requirements to close to new enrollment.
Response:
It isn't clear at this point what kind of overlap there might be between cost plans affected by the cost plan competition requirements and those cost plans that would have to stop accepting enrollment because of sharing a parent organization with an MA plan. However, we do not believe that a significant number of cost plans will be affected by expanding the requirement to include a shared parent organization, as the requirement is largely prospective and designed to prevent a situation that we did not originally account for, but which we believe could lead to potential harm for enrollees.
Comment:
A commenter stated that “the test should not only be whether entities have the same parent but also whether the two entities are affiliated, including if one entity is the parent of the other (rather than shares a parent).”
Response:
We agree with the commenter with respect to the specific example cited and have included language in the final rule that will also trigger a prohibition on new enrollment in a cost plan in situations in which a parent organization and its subsidiary have a cost contract and MA plan in the same service area. In addition to the proposed language that MA organizations “Not 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,” we are adding to § 422.503 (b)(4)(vi)(G)(5)(ii) that MA organizations “Not accept, as either the parent organization owning a controlling interest of or subsidiary of 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.” The language from the initial proposal along with the additional language will now be contained in § 422.503 (b)(4)(vi)(G)(5)(i) and (ii).
Comment:
A few commenters stated that CMS should define a parent organization as an entity that “exercises a controlling interest in the applicant.” Other commenters stated that we should limit the definition of “parent organization” to the context of this provision only as our proposed definition could create inconsistencies in the Part C and D polices and guidance or have “unanticipated implications that are difficult to identify at this time.” One of the commenters, who asked us to limit the application of the “parent organization” definition to this provision only, stated that it would support our proposal if we clarified that the parent organization must have a “controlling interest” in the subsidiary legal entities in question.
Response:
In the proposed rule, we specifically solicited comments on whether the requirement should be applied to a parent organization with less than 100 percent interest in the affected cost contract and MA plan. We agree that a controlling interest is a reasonable standard that is consistent with our intention to prevent an organization from having control over both a cost contract and MA plan in the same service area. We also agree that the threshold for determining when the prohibition should be applied is best established in the context of this provision and thus are not finalizing the definition of “parent organization” in § 422.2 . Instead, we are including the threshold for the prohibition in modifications in § 422.503(b)(4)(vi)(G)(5)(i) and (ii). These sections will now state that any entity seeking to contract as an MA organization—
• Not accept, or share a corporate parent organization owning a controlling interest in 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.
• Not accept, as either the parent organization owning a controlling interest of, or subsidiary of, 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.
We are finalizing the provisions of the proposed rule with the revisions and additions discussed in this section III.A.1 of this final rule.
2. Authority To Impose Intermediate Sanctions and Civil Money Penalties (§§ 422.752, 423.752, 422.760 and 423.760)
Sections 1857(a) and 1860D-12(b)(1) of the Act provided the Secretary with the authority to enter into contracts with MA organizations, and Part D sponsors (respectively). Section 1857(g)(1) of the Act provided a list of contract violations and the corresponding enforcement responses (intermediate sanctions (sanctions) and/or civil money penalties (CMPs)) are listed under section 1857(g)(2) of the Act (section 1860D-12(b)(3)(E) applied these provisions to Part D contracts).
We proposed two changes to our existing authority to impose sanctions and CMPs based on section 6408 of the Affordable Care Act (Pub. L. 111-148). The provisions of section 6408 provided CMS with the authority to impose intermediate sanctions or CMPs for violations of the Part C and D marketing and enrollment requirements. As well as, 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. Additionally, we proposed 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).
Comment:
A commenter expressed concern and stated that MA organizations and Part D sponsors should be given the opportunity to refute marketing or other allegations of
non-compliance prior to sanctions and/or CMPs being imposed.
Response:
Enforcement actions are only typically taken based on substantiated, well documented instances of non-compliance and in the case of both a sanction and a CMP, even after they are issued, MA organizations and Part D sponsors are given an opportunity to rebut or appeal CMS' determination through a formal appeals process.
Comment:
A few commenters requested clarification regarding the new sanction authority, specifically the language that would allow CMS 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. The commenters requested that CMS clarify that this would not apply to organizations that perform facilitated or auto-enrollment, passive enrollment, seamless enrollment or requests from Employer Group Waiver Plans (EGWPs).
Response:
In the proposed rule, we proposed to amend the regulation text at §§ 422.752 and 423.752 by adding (a)(9), and (a)(7), respectively, which read: “. . . Except as provided under § 423.34 of this chapter, enrolls an individual in any plan under this part without the prior consent of the individual or the designee of the individual.” Section 423.34 specifically refers to enrollment of individuals who receive the low income subsidy (LIS) and are therefore subject to facilitated or auto-enrollment. Therefore, we believe that the proposed regulation text already makes clear that this provision would not apply to those organizations that are performing facilitated enrollment of LIS beneficiaries. Additionally, passive enrollment and use of the seamless enrollment option are initiated or approved by CMS, respectively. Therefore, an organization who is contacted by CMS to receive passive enrollment would not be considered to have performed enrollment without prior consent. As for the seamless enrollment option, as these proposals must be submitted to and approved by CMS, as long as organizations are following CMS' enrollment guidance in Chapter 2, § 40.1.4, an organization, again, would not be considered as enrolling without prior consent and would, therefore, not be considered for a possible sanction. Finally, an organization who is accepting group or individual enrollment requests from EGWPs must follow CMS' enrollment guidance in Chapter 2, § 40.1.6. As long as CMS enrollment guidance is being followed with respect to processing these enrollments, CMS would not consider MA and Part D organizations in violation of the new requirement.
Comment:
One commenter stated that only one organization, either CMS or OIG should have CMP authority and that there should be no overlapping authority. They went on to state that if CMS proposed to allow overlapping CMP authority that CMS agree that the total amount of the CMPs issued not exceed what either CMS or OIG could impose separately.
Response:
It is not CMS' intent to create overlapping CMP authority, simply to clarify our existing CMP authority. However, to the extent CMS or OIG were planning on pursuing a CMP, we have internal mechanisms in place to ensure that the other entity within the department is not simultaneously pursuing a CMP for the same or similar conduct. If we were to determine that OIG was pursuing a CMP for similar conduct, we would coordinate with the OIG so that only one CMP action would move forward.
Comment:
One commenter requested that CMS not finalize this provision because they believe the current division of authority to impose CMPs should remain unchanged, with the authority to CMP for certain violations remaining with OIG, instead of adding to CMS' existing CMP authority, as this approach ensures a natural division of power and oversight expected from government agencies.
Response:
CMS has always had the statutory authority to impose CMPs for the violations currently designated as belonging solely to the OIG in the regulation. However, CMS agrees that there are certain violations that should be retained solely by OIG for purposes of imposing CMPs, which is why the proposed rule states that the authority to impose CMPs for violations listed at §§ 422.752(a)(5) and 423.752(a)(5), involving misrepresentation or falsification of information furnished to CMS, an individual, or other entity, will continue to reside solely with the OIG.
Comment:
One commenter, in addition to expressing support for our proposal, stated that CMS should authorize use of monies collected from CMPs to allow states to contract with, or grant funds to entities, provided that the funds are used for CMS approved projects to protect or improve SNF services for residents.
Response:
We thank the commenter for their support and we will explore in the future if such arrangements are allowed within our current statutory authority.
Comment:
We received several comments that supported the new proposed sanction authority for marketing and enrollment violations.
Response:
We thank the commenters for their support.
After careful consideration of all of the comments we received, we are finalizing these proposals without modification.
3. Contract Termination Notification Requirements and Contract Termination Basis (§§ 422.510 and 423.509)
Sections 1857(c) and 1860D-12(b)(3)(B) of the Act provided us with the authority to terminate a Part C or D sponsoring organization's contract. Sections 1857(h)(1)(B) and 1860D-12(b)(3)(F) of the Act provided us with the procedures necessary to facilitate the termination of those contracts. We proposed three revisions to our existing regulations that relate to contract termination.
First, we proposed to clarify the scope of our authority to terminate Part C and D contracts under §§ 422.510(a) and 423.509(a) by modifying the language at §§ 422.510(a) and 423.509(a) to separate the statutory bases for termination from our examples of specific violations which meet the standard for termination established by the statute. We proposed to effectuate this change by renumbering the list of bases contained in §§ 422.510(a) and 423.509(a).
Second, we proposed 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 Part D sponsoring organization's contract, we must notify the organization in writing 90 days before the intended date of termination. We proposed to shorten the notification timeframe from 90 days to 45 days. Additionally, in an effort to respond to changes in the media and information technology landscape, we proposed a slight modification to the termination notification provision for the general public at §§ 422.510(b)(1)(iii) and 423.509(b)(1)(iii) which includes the contracting organizations releasing 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.
Finally, we proposed 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 proposed to replace the word “fails” with “failed” so that it reads consistently throughout §§ 422.510 and 423.509.
Comment:
Several commenters opposed our proposal to shorten the notification period for contract termination from 90 days to 45 days. Commenters made several arguments supporting their opposition to the shortened notification timeframe, but most stated that it is not enough time to ensure members' needs are adequately addressed, specifically noting the difficulty in effectively communicating the change with their members and ensuring their members were effectively transitioned to a new plan. Other commenters stated that the timeframe was too short to provide adequate notice to affected providers and vendors. Yet another commenter stated that the shortened timeframe did not allow enough time for a plan to appeal the termination. A final commenter noted that the shortened timeframe would increase costs to the contracting organization if the termination period is reduced.
Response:
After carefully considering the commenters' concerns, we respectfully disagree that these concerns outweigh the need to protect beneficiaries and have them moved from a plan that is in such substantial non-compliance with our regulations that CMS would proceed with termination. Plans that receive a notice of termination from CMS are instructed that they must provide notice to their affected beneficiaries at least 30 days prior to the effective date of the termination. If CMS provides their notice of termination to contracting organizations 45 days before the effective date of the termination, this affords plans 15 days to issue their notice to enrollees while still complying with the existing 30-day beneficiary notification requirements. While we do request that terminated plans work with the receiving plan to transition enrollee data and records, it is not expected that these tasks would be completed by the effective date of the termination, but would instead begin upon transfer of the enrollees once the termination was actually effective.
As for adequate notification to affected vendors and providers, it is the responsibility of the contracting organization to design their contracts with their providers and vendors in a manner that recognizes possible contract actions, such as termination, that could be taken by CMS. For example, all plans that have a contract with CMS could ultimately be subject to immediate termination if they are found in such substantial non-compliance by CMS that it poses an imminent and serious risk to Medicare enrollees. Therefore, most, if not all plans, likely have clauses in their provider and vendor contracts that allow them to terminate these contracts expeditiously with the affected entities in the event of a contract termination by CMS.
We also do not agree that the shortened timeframe in any way affects a contracting organization's ability to appeal. Contracting organizations who are subject to a contract termination in §§ 422.510(b) or 423.509(b) must file their request for a hearing within 15 days from the date of receipt of the notice of termination. A timely filed request for hearing effectively stays the termination proceeding until a hearing decision is reached. Consequently, shortening the notice of termination from 90 to 45 days should have no impact on a contracting organization's ability to file an appeal of the contract termination.
Finally, we do not agree that the shortened notice timeframe to effectuate a termination would result in increased costs to an organization. We already have the ability to prorate its payment to an organization for terminations that are effective in the middle of a month; consequently we do not agree that shortening the notification timeframe would in any way change the CMS's current approach to payment or recoupment of capitated payments in these circumstances.
Comment:
One commenter suggested that CMS should have different notification timeframes for termination. They recommended that 90 day notice be provided to all post-acute care (PAC) providers as well as to beneficiaries in PAC. They stated that 45 days for notice may be sufficient for non-post-acute care beneficiaries, but not for people in a short stay setting. They also suggested that MA plans that are serving full dual eligible beneficiaries should be required to provide 180 day notice to individuals and providers.
Response:
CMS' proposal to shorten the notification of termination from 90 days to 45 days affects the amount of notice that CMS must give to an MA or Part D organization prior to moving forward with a termination action. The timeframe in which that organization must then notify their beneficiaries, which is currently 30 days, is not being changed in this proposal. While we appreciate the commenter's suggestion, we believe that it would be incredibly burdensome to organizations and confusing to our beneficiaries to implement such a striated notification process for our beneficiaries during a termination. Additionally, if we were to adopt the commenter's suggestion of a 90 day notice period for beneficiaries in a PAC setting or 180 day notice for dual eligible beneficiaries, this would require that we give organizations even more advance notice of our intent to terminate than we do currently, which is contrary to the ultimate goal of our proposal, which is to remove beneficiaries as quickly as possible from a plan with such significant noncompliance issues that CMS is pursuing termination. Consequently, we plan to proceed with our proposed change.
Comment:
Several commenters supported CMS' proposed revisions to the contract termination authority (§§ 422.510 and 423.509) and stated that these measures will help enforce consumer protections and enhance plan accountability.
Response:
We thank the commenters for their support.
After consideration of the public comment(s) received, we are finalizing these proposals without modification. We note that the amendatory instruction to the regulation text in this final rule more precisely describes the redesignation of subparagraph (a)(4) of § 423.509 than that found in the proposed rule.
4. Reducing the Burden of the Compliance Program Training Requirements (§§ 422.503(b)(4)(vi)(C) and 423.504(b)(4)(vi)(C))
Section 1857(a) and section 1860D-12(b)(1) of the Act provided the Secretary with the authority to enter into contracts with MA organizations and Part D sponsors (respectively). 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. We first established that all Part C and Part D contracting organizations have 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)(vi). We later 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). 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 continued 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 19688).
Consequently, we proposed in this rule to require that all contracting organizations accept a certificate of completion of the CMS developed training as satisfaction of this general compliance program training requirement. We proposed 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 first-tier, downstream and related entities.
Comment:
One commenter questioned if there would be a fee associated with the CMS mandated training.
Response:
There is no fee to take the CMS Standardized General Compliance Program Training; it is provided free of charge.
Comment:
Multiple commenters stated that Part C and Part D contracting organizations should have the option of using the CMS Standardized General Compliance Program Training and Education Module. The commenters wrote that there should be flexibility in meeting the proposed training requirement, and that CMS should consider allowing plan sponsors to utilize their own training or the training developed by established training companies to meet the requirement.
Response:
The CMS Standardized General Compliance Program Training and Education Module was created to reduce the burden on sponsors and FDRs. If we continue to allow sponsors to modify or utilize their own training in lieu of using the CMS Compliance training, it will no longer ensure the elimination of the prior duplication of effort that so many FDRs stated was creating a huge burden on their operation. This is why CMS proposed that only our training can be used, as it is the only means to ensure that duplication of effort is avoided for FDRs who hold contracts with multiple Part C and Part D contracting organizations.
Comment:
One commenter raised concerns over the significant amount of time required to complete the current CMS Compliance training and stated that it may take time away from other areas of training the organization has deemed necessary through their own internal risk assessments. They suggested CMS consider modifying the requirement to allow the longer training initially and developing a shorter “refresher” version that could be taken annually thereafter.
Response:
We will not modify the existing CMS Standardized General Compliance Program Training at this time. However, we recognize the commenter's concern and will take under consideration the development of a refresher training module for future use.
Comment:
A few commenters recommended that CMS establish a single centralized electronic location where FDRs could obtain this training, and that the centralized location would also serve as a repository to hold attestations of training completion accessible to Part C and Part D contracting organizations for compliance oversight purposes. Commenters suggested it be searchable or that CMS provide updates, one suggesting daily reports be pushed to each MA organization and Part D sponsor so that they could track compliance with the training requirement. One other commenter suggested that the training be provided in a Sharable Content Object Reference Model (SCORM) format for downloading into various organizations' systems.
Response:
The training is in a centralized location on the Medicare Learning Network. All who take the training will be able to print out a certificate of completion to prove they have completed the training. It is the responsibility of Part C and Part D contracting organizations to determine how to best retrieve and catalog this information from their FDRs. CMS is unable, at this time, to provide the capacity for a publicly searchable database of users who have completed that training or a system that would allow reports to be sent to the various contracting organizations regarding the training status of various FDR organizations. We will consider and determine if our training module could be available for download into the format suggested by commenters, but we would need to ensure that the content could not be modified to ensure the integrity and completeness of the training module.
Comment:
One commenter suggested CMS leverage the existing Compliance Training, Education & Outreach (CTEO) site to support this initiative and to interactively execute the training and collect and track the required attestations.
Response:
When we developed the Standardized General Compliance Program Training, the CTEO Web site was not yet in existence. We will take the commenter's suggestion under consideration and further explore that Web site's capability to determine if it actually exceeds the current capability of the Medicare Learning Network, where the training is currently housed.
Comment:
A few commenters recommended maintaining the current policy of allowing flexibility in how the training requirement is met. These commenters stated the current training requirements meet their needs because it allows options and reduces the burden on various sectors of the industry. They stated that various organizations had already invested resources to become compliant and to develop efficient means of both delivering and tracking the training. The flexibility in the current regulations allows plan sponsors to work in concert with FDRs to develop effective training for those specific entities and their existing learning models.
Response:
We recognize that the current compliance program training requirement does meet the needs of some contracting organizations. However, based on public feedback received previously, as well as in response to this proposed change, we continue to believe that the proposed approach is most efficient and effective for the majority of FDRs and contracting organizations.
Comment:
Many commenters requested clarification regarding who is required to take the training: Providers, brokers, FDRs, and/or internal employees.
Response:
The compliance and fraud, waste, and abuse (FWA) training and education requirement applies to all delegated entities (which may include agents/brokers) whom the Part C or Part D contracting organization qualifies as an FDR using the definition at 42 CFR §§ 422.500(b) and 423.500. Whether a Part C or Part D contracting organization identifies a certain entity or individual provider as an FDR depends on the contractual relationship and/or written agreement between the entity/individual and the contracting organization. The compliance and FWA training is not intended to be mandatory for the employees of those contracting organizations.
Comment:
Several commenters wanted to know if this training would satisfy the FWA and Compliance training requirements.
Response:
There is both a FWA and a Compliance training module available on the Medicare Learning Network,
FDRs must take both modules in order to satisfy the entire training requirement.
Comment:
A few comments requested clarification regarding who was deemed for purposes of the FWA training requirement (for example, is it just the provider participating in Medicare FFS or also all of the employees that work in his office, similarly with a hospital participating in Medicare, does it extend to their employees). Commenters also requested if CMS was exploring deeming status for providers in the Part D program.
Response:
This question is outside of the scope of this regulation. We did not propose any changes to the FWA training module or the associated deeming requirements. Therefore, we are unable to address your question at this time.
Comment:
Several commenters had questions regarding the one-pager that contracting organizations can provide with organization specific information, and requested whether this meets the requirements for distributing their codes of conduct (COC) or standards of conduct (SOC) located in Chapter 9 of Pub. 100-18, Medicare Prescription Drug Manual, and Chapter 21 of Pub. 100-16 of the Medicare Advantage Manual. Some commenters inquired if this new proposal could be construed to forbid them from distributing their COC/SOC to their FDRs.
Response:
We intend that the standardized FWA and Compliance Training modules will cover the basic training requirements. We recognize that each contracting organization has specific information that must be shared with their FDRs regarding the organization's specific operations. The one-pager was suggested for organizations to communicate unique information that is usually shared in FWA/Compliance such as relevant organization contact information (for example, Web site address, hotline/ethics phone numbers) the Compliance Officer's contact information, the Compliance Department staff, and possibly even online access to the COC/SOC or disciplinary policies. Our experience has shown that many contracting organizations issue their COC/SOC electronically (internally and externally) and/or create Web sites designated for their FDRs to locate the information mentioned previously. Contracting organizations must continue to distribute their COC/SOC to all of their employees, FDRs, board members, etc. Nothing is this regulation should be interpreted to preclude organizations from satisfying the seven elements of the compliance program requirements.
Comment:
The commenters suggested that feedback should be solicited from the plans to assist with improving the content of the training, specifically including more examples that are relevant to FDRs, as commenters mentioned the modules examples are often organization-centric.
Response:
We always welcome feedback from contracting organizations and FDRs with respect to improving our training products. Organizations, entities or individuals who have suggestions should submit them to the following mailbox:
Parts_C_and _D_CP_Guidelines@cms.hhs.gov.
Comment:
Some commenters stated that CMS should consider how it can implement this proposal in a way that reduces administrative burdens on contracting organizations and FDRs, as new processes to collect and track attestations may be difficult and time consuming. Many suggested that a January 1, 2015 effective date was an insufficient amount of time to set up such elaborate processes and recommended that these provisions be effective no earlier than January 1, 2016.
Response:
CMS recognizes the administrative burden imposed on the contracting organizations and their FDRs. The primary goal of this proposal is to reduce that administrative burden by instituting a uniform compliance training module and we believe that contracting organizations are in the best position to determine the most effective way to collect and track compliance amongst their FDRs. However, we recognize that setting up these new processes may take time, along with potentially updating contracts to reflect the new requirements. Therefore, we will delay the implementation of this provision to January 1, 2016.
Comment:
The largest number of commenters represented FDRs that wrote in support of the proposed compliance training program requirements and use of the CMS Standardized General Compliance Program Training, agreeing that it would greatly reduce burden on FDRs.
Response:
We thank the commenters for their support.
After careful consideration of all of the comments received, we are finalizing this proposal with the one modification discussed previously, with a delayed applicability date of January 1, 2016.
5. Procedures for Imposing Intermediate Sanctions and Civil Money Penalties Under Parts C and D (§§ 422.756 and 423.756)
Sections 1857(g) and 1860D-12(b)(3)(E) of the Act provide the Secretary the ability to impose intermediate sanctions on MA organizations and PDP sponsors. Intermediate sanctions consist of suspension of enrollment, suspension of marketing and suspension of payment. Current regulations governing intermediate sanctions are contained in subparts O of part 422 and part 423. Sections 422.756 and 423.756 provide specific procedures for imposing intermediate sanctions and include provisions which address: The duration of the sanction; and the standard that we apply when determining if a sanction should be lifted.
We proposed to expand the potential applicability of the test period requirement to three types of intermediate sanctions by modifying the existing rules 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. Second, we proposed to clarify the enrollment parameters for sanctioned sponsoring organizations offering Part D plans to include language specifying that a sanctioned plan is not available to receive automatically assigned beneficiaries for the entire duration or a portion of the testing period. We proposed to modify the regulation text at §§ 422.756 and 423.756 to reflect these changes.
Comment:
One commenter questioned clarification on what CMS considers a contract violation of marketing requirements and requested if violations would be based solely on allegations of misconduct.
Response:
Marketing standards for MA organizations and Part D sponsors are codified in subpart V of parts 422 and 423. The current Medicare Marketing guidelines are located in Chapter 3 of
Pub. 100-16, Medicare Managed Care Manual, and Chapter 3 of Pub.100-18, The Medicare Prescription Drug Manual,
which should provide sponsors with guidance regarding current marketing requirements. With respect to contract violations being based on unsubstantiated allegations of wrong-doing, enforcement actions are only taken based on substantiated, well documented instances of non-compliance. Additionally, MA organizations and Part D sponsors that are sanctioned are given an opportunity to rebut or appeal our determination through a formal appeals process.
Comment:
One commenter suggested the prohibition on auto-enrollment into plans under a test period should also apply to passive enrollment. Specifically, the commenter stated that
Medicare-Medicaid eligible individuals should not be passively enrolled into an MA or an MA Special Needs Plan (SNP) that is under sanction or under sanction and in a test period as part of a demonstration or a state developed integrated plan product.
Response:
Plans that are under a sanction are not eligible to receive enrollments. However, we have the discretion to require a sanctioned plan to market or accept enrollments for a limited period to assist in making a determination as to whether the bases for imposing the sanction have been fully corrected and are not likely to recur. As stated previously, sanctioned sponsoring organizations offering a Part D benefit would not be eligible to receive automatically assigned beneficiaries during the test period. During a “test period” the sanction(s) remain in effect.
Comment:
One commenter requested that we extend the proposal to also not allow passive enrollment into plans that are coming off of sanction or are currently in a test period until we have determined they are ready.
Response:
CMS has determined that it is legally permissible to provide for enrollment in an MA or Part D plan under a passive enrollment request process in specific, limited circumstances generally associated with either immediate plan terminations or in other situation where CMS determines that remaining enrolled in the plan would pose potential harm to members. We determine when passive enrollment is appropriate. In evaluating whether such CMS-directed enrollee movements are appropriate, a key factor is the determination as to whether the receiving plan is essentially equivalent to (or better than) the current plan from an overall perspective.
Therefore, in situations where passive enrollment is determined permissible, like an immediate plan termination, CMS would factor in a number of criteria, including the receiving plan's current premium, benefit and formulary structure, as well as plan past performance. In any event, our goal would be to ensure that those affected members suffered as little disruption as possible during their transition. Plans that were under sanction at the time of a passive enrollment would not be considered a viable option for affected enrollees and it is unlikely that sponsors under a test period would either. However, if a sponsor who was removed from sanction and was under a test period met several other criteria for receiving passive enrollment (that is, plan's benefit and formulary structure was largely the same and their premium was not significantly higher), we may consider them among the group of available plans to receive passive enrollment.
Comment:
A few commenters requested clarification regarding the new sanction authority, specifically the language that would allow CMS 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. The commenters asked that CMS clarify that this would not apply to organizations that perform facilitated or auto-enrollment, passive enrollment, seamless enrollment or group or individual enrollment requests from EGWPs.
Response:
In the proposed rule, we proposed to amend the regulation text at §§ 422.752 and 423.752 by adding subparagraph (a)(9), which reads: “. . .Except as provided under § 423.34 of this chapter, enrolls an individual in any plan under this part without the prior consent of the individual or the designee of the individual.” Section 423.34 specifically refers to enrollment of individuals who receive the low income subsidy (LIS) and are therefore subject to facilitated or auto-enrollment. Therefore, we believe that the proposed regulation text already makes clear that this provision would not apply to those organizations that are performing facilitated enrollment of LIS beneficiaries. Additionally, passive enrollment and use of the seamless enrollment option are initiated or approved by CMS, respectively. Therefore, an organization who is contacted by CMS to receive passive enrollment would not be considered to have performed enrollment without prior consent. As for the seamless enrollment option, as these proposals must be submitted to and approved by CMS, as long as organizations are following CMS' enrollment guidance in Chapter 2, § 40.1.4, and have received CMS' approval, an organization again would not be considered as enrolling without prior consent and would therefore not be considered for a possible sanction. Finally an organization who is accepting enrollment requests for an employer or union sponsored plan using the group enrollment mechanism must follow CMS' enrollment guidance in Chapter 2, § 40.1.6.1. As long as CMS enrollment guidance is being followed with respect to processing these enrollments, CMS would not consider MA and Part D organizations in violation of the new requirement. However, we expect that requests for enrollment into an employer or union sponsored plan outside of the group enrollment process (that is, beneficiary initiated enrollment requests) follow all requirements, including prior consent, applicable to any other individual enrollment request.
Comment:
Several commenters expressed support for our proposal to expand the use of the “test period” requirement to all intermediate sanctions, and support the proposal that previously sanctioned below-the-benchmark Part D plans not be allowed to receive or process auto-enrollments or reassignments until they are determined to be ready by CMS.
Response:
We thank the commenters for their support.
After careful consideration of the comments received, we are finalizing these proposals without modification. We inadvertently failed to include proposed regulation text for § 423.756 that corresponds to this proposal. In this final rule, we finalize amendments to §§ 422.756 and 423.756 that are virtually identical to implement this proposal.
6. Timely Access to Mail Order Services (§ 423.120)
Section 1860D-12(b)(3) of the Act authorizes the Secretary to include contract terms for Part D sponsors, not inconsistent with the Part C and D statutes, as necessary and appropriate. Section 423.120(a)(3) specifies that a Part D sponsor's contracted network may include non-retail pharmacies, including mail order pharmacies, so long as the network access requirements are met. Part D plans are increasingly entering into contracts with mail order pharmacies to offer beneficiaries an alternative way to fill prescriptions under the Part D benefit, often at much lower cost sharing than is available at network retail pharmacies. While mail order pharmacies make up a relatively small percentage of total prescriptions filled under the Part D program, we are committed to ensuring consistent and reliable beneficiary access to medications, regardless of what type of pharmacy fills the prescriptions.
Section 1860D-4 of the Act describes the various beneficiary protections in place in the Part D program. 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.
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 proposed 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.
Therefore, we proposed 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 would 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 believed 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 solicited 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 received the following comments and our response follows:
Comment:
A few commenters questioned why we proposed turnaround times of 3 and 5 days if we list in preamble that standard turnaround times are 7 to 10 days for delivery.
Response:
The preamble discussion surrounding delivery of prescriptions within 7 to 10 days is from the perspective of the beneficiary; listing the total time from when a medication is ordered to the time it is delivered. Importantly, this includes shipping time. The proposed fulfillment standards were specific to mail order pharmacy processing times and did not include actual time in shipping. In other words, the 3 to 5-day turnaround time only refers to the timeframe from when the pharmacy receives the order until the pharmacy ships the order.
Comment:
Many commenters expressed concerns that 5 business days is too short of a time frame to require mail order pharmacies to resolve some issues when they arise (such as manufacturer drug shortages), many of which are outside the control of the pharmacy. Many commenters noted unique timeline concerns specific to specialty medications, such as cold chain shipping and needing to contact the beneficiary to coordinate delivery. Multiple commenters suggested that additional leeway is also needed to accommodate issues such as natural disasters. Multiple commenters suggested that mail order pharmacies should contact beneficiaries as a good customer service practice when any delay in filling will prevent an order from shipping within 5 days. Many commenters noted that they currently would be able to meet a 3-day turnaround standard for filling orders not requiring follow up contact with the beneficiary or prescriber.
Response:
We recognize that some interventions may require more than 5 business days to resolve. In those cases, we agree with the suggestion from multiple commenters that mail order pharmacies should contact beneficiaries as a good customer service practice when any delay in filling will prevent an order from shipping within 5 days. However, in light of the comments received regarding a variety of situations that we had not considered, including some outside of the pharmacy's control that could create delays longer than 5 days, we are not finalizing the proposal to establish fulfillment standards for mail order. Instead, we will continue analysis on mail order fulfillment time frames, including evaluating the impact of the implementation of the auto-ship beneficiary consent policy finalized in the 2014 Call Letter. In addition, Part D sponsors are expected to follow best practices by making clear their expected delivery turnaround times in their beneficiary materials, consistently meeting such delivery time frames, and having contingency plans for when they cannot, such as allowing retail access at mail order cost sharing levels if necessary. The volume of complaints that we receive related to mail order delivery suggests that beneficiary expectations are not consistently being met. We will increase our monitoring of mail order pharmacies, and will consider the need to establish standards and requirements in the future. Based on the comments submitted, additional consideration may be necessary surrounding specialty medications and their delivery, especially when there are cold chain or other shipping considerations. We reviewed the information provided on how specialty pharmacy differs from other mail order deliveries, and agree that additional consideration should be given to these pharmacies and medications in any future guidance. Additionally, we will clarify existing guidance about exception processes and coverage denials to ensure that mail order pharmacies provide beneficiaries notice of non-fulfillment of a prescription as expeditiously as possible. Current guidance on disaster responses and drug shortages still apply, and we encourage sponsors to communicate with their enrollees when unique situations like these arise.
Comment:
A few commenters suggested that mail order turnaround times are best left to state Boards of Pharmacy to monitor, instead of being set in regulation.
Response:
We proposed specifying parameters for timely mail order fulfillment, consistent with the authority given to the Secretary to specify additional contract terms not inconsistent with the Part D statute. However, we had not considered the potential conflict or duplication with state-based requirements and appreciate the comments. We will take this under consideration as we consider establishing requirements for Part D sponsors offering a mail order benefit in the future.
Comment:
Some commenters wrote that turnaround times would be better defined in guidance or incorporated in star ratings or other quality metrics.
Response:
We appreciate the suggestion. As we will not be finalizing the proposed fulfillment standards in this final rule, we are exploring alternatives for ensuring consistent and predictable access to medications for beneficiaries in a plan offering a mail order benefit. As part of this effort, we are currently developing a study of how mail order benefits are used within the Part D benefit. The comments received on the proposed rule and the results of this study will be considered when determining whether fulfilment standards should be included in future star ratings measures, as well as used to inform the need for future guidance or rulemaking. Additionally, we will increase our monitoring and analysis of mail order-related complaints in the CTM and explore setting a threshold for the volume or severity of complaints triggering a review by CMS. We remain very concerned by the high level of complaints received relating to mail order, and take seriously the issues raised by beneficiaries. We are also exploring how fulfillment of plan-designated turnaround times listed in marketing or other beneficiary materials could be included within the audit framework.
Comment:
One commenter wrote in with concerns that the methodology used in two CMS studies cited in another provision were problematic and stated that no regulation proposals relating to mail order should be finalized until corrected and reexamined.
Response:
The studies noted by the commenter were not used when designing the proposal specific to timely delivery of mail order prescriptions.
Comment:
Some commenters suggested that the policy announced in the CMS 2014 Call Letter that pharmacies obtain beneficiary consent prior to shipping any medications that the beneficiary did not affirmatively order directly affects the timeline for order fulfilment and any defined turnaround times for delivery should be adjusted accordingly.
Response:
We recognize that the CMS 2014 Call Letter auto-ship policy necessitates an increased level of coordination with the beneficiary for some pharmacies, when filling prescriptions that the beneficiary did not directly request (such as new orders submitted directly by the provider or refills prompted by an automatic delivery program). We will not be finalizing the proposed fulfillment standards in this final rule, but encourage all plan sponsors to consider the need for coordination with the beneficiary when establishing and marketing average turnaround time estimates for their members.
Comment:
A few commenters suggested that beneficiaries should be allowed to fill their medications at the retail pharmacy of their choice, at the same cost sharing level as mail order, if a mail order pharmacy encounters any delays, or delays extending beyond 5 days.
Response:
While this was not a part of our proposal, and we will not be finalizing any new requirements at this time, we do agree with commenters that this would be an important beneficiary protection. We believe that best practices for addressing a lost or delayed order would include plan sponsors providing clear and timely guidance to the beneficiary in the event of a lost or delayed order, including a list of options for obtaining a medication. Part D sponsors should have contingencies in place when issues are encountered that lead to a delay and potentially a gap in therapy. This could include offering beneficiaries the ability to fill a delayed mail order prescription at a retail pharmacy and pay no more than what they would have been charged by a mail order pharmacy. The need to prevent gaps in therapy for beneficiaries relying on mail order pharmacies remains a significant concern to us.
In summary, we are not finalizing any fulfillment standards for mail order prescriptions, in light of the concerns raised. We will use the information gained from our mail order study and from the public comments submitted to explore the need for additional guidance or rulemaking in the future. The need to ensure consistent access to and prevent gaps in therapy for enrollees relying on mail order for their medications continues to be a significant concern.
We additionally solicited 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 received the following comments and our response follows:
Comment:
Many commenters stated that additional requirements for beneficiary materials would enhance mail order services and that this would be a positive change for beneficiaries. These commenters noted that clear definitions of requirements are needed to resolve issues, ensure consistent access, and ensure no gaps in therapy.
Response:
We appreciate the comments. We intend to conduct a study of mail order benefits offered by Part D sponsors and will use this, and the information received from public comments, to inform changes to beneficiary materials relating to mail order. At a minimum, we expect sponsors offering mail order services to follow best practices by clearly listing estimated delivery times in their marketing and beneficiary materials. In the event of a failure to meet plan-designated timeframes for delivery, as a best practice sponsors should be prepared to take the steps necessary to provide their enrollee the medication in a timely manner in order to avoid gaps in therapy. This could include offering enrollees the option to obtain delayed medications at a retail pharmacy at the same cost sharing level as mail order.
We also welcomed 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 uninterrupted 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. We received the following comments and our response follows:
Comment:
A few commenters agreed that mail order is not an appropriate venue for filling 30 day supplies of medications.
Response:
We appreciate the comments and will explore how often mail order is used for short days' supplies of medications as a part of the current study on mail order benefits.
Comment:
Some commenters noted that specialty pharmacies often dispense medications by mail order in an amount lasting 1 month or less.
Response:
We agree with the comments that noted some specialty medications may be best supplied, when supplied by mail order, in quantities less than a 3 month supply, due to frequent dose titrations, financial concerns, or applicable controlled substance laws.
We did not propose any specific regulatory requirements to mail order for 30-day supplies or less. We are currently analyzing the types of prescriptions filled by mail order pharmacies and will use the information gained from this to explore the need for future guidance or rulemaking that could help ensure consistent timely access for Part D beneficiaries opting to use mail order for both short and extended days' supplies.
7. Agent/Broker Compensation Requirements (§§ 422.2274 and 423.2274)
Section 103(b)(1)(B) of MIPPA revised the Act to charge the Secretary with establishing guidelines to ”ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the MA plan that is intended to best meet their health care needs.” Section 103(b)(2) of MIPPA revised the Act to apply these same guidelines to Part D sponsors. Our program experience indicates that some agents may encourage beneficiaries to enroll in plans that offer higher commissions without regard to whether plan benefits meet the beneficiaries' health needs. In recognition that agents and brokers play a significant role in providing guidance and advice to beneficiaries and are in a unique position to influence beneficiary choice, we had proposed, prior to the enactment of MIPPA, a rule to regulate agent and broker compensation. To implement the MIPAA provisions and relying in part on comments in response to our previously proposed rule, we adopted an interim final rule on September 18, 2008, entitled “Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Final Marketing Provisions” (73 FR 554226), which, among other things, established the current compensation structure for agents and brokers as it applies to Parts C and D. That rule remains significantly in place at §§ 422.2274 and 423.2274, and our experience since then indicates that revision of the compensation requirements is necessary to ensure that we continue to meet our statutory mandate.
The current compensation structure is comprised of a 6-year compensation cycle that began in Contract Year (CY) 2009. MA organizations and Part D sponsors were to provide an initial compensation payment to independent agents for new enrollees (Year 1) and pay a renewal rate (equal to 50 percent of the initial year compensation) to independent agents for Years 2 through 6. These rates were to be adjusted annually based on changes to the MA payment rates or Part D parameters as established by CMS. We later amended the regulations to allow MA organizations and Part D sponsors to compensate independent agents and brokers annually using an amount at or below the Fair Market Value (FMV). (See the final rule with comment period entitled, “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Changes” (77 FR 22072) published in the April 12, 2012
Federal Register
.)
The first 6-year cycle ended at the end of CY 2013, on December 31, 2013. The first year, CY 2009, was considered to be the first renewal year for those already enrolled, effectively making CY 2009 the second full year of compensation. Because our regulations were silent regarding compensation amounts for Year 7 and beyond, we stated in our Final Call Letter for Contract Year 2014, issued on April 1, 2013, that MA organizations and Part D sponsors could, at their discretion, pay agents and brokers the renewal amount for Year 7 and beyond. However, this subregulatory guidance was intended to be a temporary measure, pending final changes to our regulations.
Under the current structure, MA organizations and Part D sponsors pay an initial rate for the first year, and then a renewal payment of 50 percent of the initial compensation paid to the agent for years 2 through 6. This structure has proven to be complicated to implement and monitor as it requires the MA organization or Part D sponsor to track the compensation paid for every enrollee's initial enrollment, and calculate the renewal rate based on that initial payment. In our NPRM, dated January 10, 2014, we provided a detailed example of the complexities of the current compensation structure. Summarizing the current complexities, every MA organization or Part D sponsor has to know, at any given time, the amount of the initial compensation for each plan year—going back as far as 2009—in which the member enrolled in order to pay the correct compensation amount to the agent for the current contract year. For new members, MA organizations and Part D sponsors must first review CMS' reports to determine whether an initial or renewal payment should be made, and then combine that information with the FMV, or, if applicable, the plan's compensation set at less than the FMV, for each plan year to ensure the correct payments are made to agents.
In addition to its complexity, we remain concerned that the current structure creates an incentive for agents and brokers to move enrollees from a plan of one parent organization to a plan of another parent organization, even for like plan-type changes. In our NPRM, we discussed and expanded upon our example of how the current system results in different payments when a beneficiary moves from one like plan to another like plan in different organizations. In these cases, the new parent organization would pay the agent 50 percent of the current initial rate of the new parent organization; not 50 percent of the original initial rate paid by the other parent organization. Thus, in cases where the FMV has increased, or the other parent organization pays a higher commission, an incentive exists for the agent to move beneficiaries from one parent organization to another. (See §§ 422.2274(a)(3) and 423.2274(a)(3)).
Since 2008, we have received inquiries from MA organizations and Part D sponsors regarding the correct calculation of agent/broker compensation, and found it necessary to take compliance actions against MA organizations and Part D sponsors for failure to comply with the compensation requirements. To the extent that there is confusion about the required levels of compensation or the timing of compensation, there could be an uneven playing field for MA organizations and Part D sponsors
operating in the same geographic area. In addition, CMS' audit findings and monitoring efforts have shown that MA organizations and Part D sponsors are having difficulty correctly administering the compensation requirements. Therefore, we proposed simpler agent/broker compensation regulations to better ensure that plan payments are correct and establish a level playing field that will further limit incentives for agents and brokers to move enrollees for financial gain.
We proposed to revise the existing compensation structure for agents and brokers so that, for new enrollments, MA organizations and Part D sponsors could make an initial payment that is no greater than the FMV amount for renewals in Year 2 and beyond, the MA organization or Part D sponsor could pay up to 35 percent of the FMV amount for the renewal year, resulting in renewal year payment changes each year if the MA organization or Part D sponsor chooses to pay 35 percent of the current FMV (that is, the renewal year FMV threshold). As is currently the case, we would interpret the FMV threshold in our annual guidance to MA organizations and Part D sponsors. This flexibility would enable MA organizations and Part D sponsors to better react to changes in the marketplace and adjust their compensation structures accordingly.
When we proposed the 35 percent renewal rate, we also discussed several different alternatives, including prohibiting compensation payments entirely beyond year 6, permitting MA organizations and Part D sponsors to pay a residual payment for year 7 and subsequent years, and permitting existing renewal payments to extend past year 7. We also evaluated different renewal amounts, including a 50 percent renewal payment for years 2 through 6 with a continuing 25 percent residual payment for years 7 and beyond. The evaluation took into account different beneficiary ages for an initial enrollment, as well as life expectancy. In the analysis, a renewal payment of 35 percent was similar in payout to the combination of a 50 percent payment for years 2 through 6 and a residual payment of 25 percent for year 7 and beyond.
In our NPRM, we stated that we believed that revising the existing compensation structure to allow MA organizations or Part D sponsors to pay up to 35 percent of the FMV for year 2 and beyond was appropriate based on several factors. First, we stated that a two-tiered (initial and renewal) payment system would be significantly less complicated than a three-tiered system (initial, 50 percent renewal for years 2 through 6, and 25 percent residual for years 7 and beyond), and would reduce administrative burden and confusion for plan sponsors. Second, our analysis determined that 35 percent is the renewal compensation level at which the present value of overall payments under a two-tiered system would be relatively equal to the present value of overall payments under a three-tiered system (taking into account the estimated mortality rates for several beneficiary age cohorts). This analysis was based on the existing commission structure basing renewal commissions on the starting year initial commission amount and not the current year FMV amount.
In order to implement the changes in the identical Part C and Part D regulations at §§ 422.2274 and 423.2274, our NPRM first proposed to revise the introductory language for each section and then define “compensation” in paragraph (a)(1) and to restate the fair market value limit on compensation for the initial year as paragraph (b)(1)(i). Second, we proposed to combine the current (a)(1)(i)(B), which addresses payments for renewals, and (a)(1)(iii), which addresses the length of time that renewals should be paid, and designate the revisions as a new (b)(1)(ii). Thus, the proposed new paragraph (b)(1)(ii) would state that plans may pay up to 35 percent of the current FMV and that renewal payments may be made for the second year of enrollment and beyond.
In addition, we proposed to modify paragraph (a)(3) to remove the 6-year cap on the compensation cycle. Currently, paragraph (a)(3) refers to policies that are replaced with a like plan during the first year or the subsequent 5 renewal years. Since we proposed to eliminate the 6-year cycle, our revised paragraph (b)(2) deletes the reference to the initial year and the 5 renewal years. By tying renewal compensation to the FMV for the renewal year, rather than to the initial year of enrollment, our proposal reduces the financial incentives for an agent or broker to encourage Medicare beneficiaries to change plans, especially from one parent organization to another parent organization. As with the current regulation, we proposed in paragraph (b)(2)(iii) that a change in enrollment to a new plan type be payable under the same rules that apply to an initial enrollment, regardless of whether the change is to an unlike plan type in the same parent organization or an unlike plan type in another parent organization. Note that, as with the current rule, our proposal only addresses compensation paid to independent agents and does not address compensation payable by an MA organization or Part D sponsor to its employees who perform services similar to agents and brokers.
We welcomed comments on both the amount of the renewal payment, as well as the proposed indefinite time frame, which are discussed in depth as follows. In summary, we received a number of comments supporting our efforts to simplify agent/broker compensation calculation. These comments were primarily from plans and industry trade groups. We will be finalizing the rule to implement a two-tiered (initial and renewal) payment system using the FMV in the current year for renewal calculations.
We received numerous comments from agents, brokers, plans and trade associations overwhelmingly opposing the 35 percent renewal rate. Based on the comments received, we will finalize the amendment to the regulations with a cap of 50 percent of the current FMV for renewals.
In response to the comments received, we also determined that some clarifications were necessary. For renewals, the payment is based on the current FMV and not the initial enrollment year FMV. For example, assume a beneficiary enrolls in an MA plan in CY 2013. The plan pays the initial FMV for CY 2013, which is $413. In CY 2015, assume the FMV is $420. The plan chooses to pay 50 percent of the FMV for renewals. The maximum renewal payment for this member for CY 2015 would be $210 ($420 * .50) instead of $207 ($413 * .50). For all enrollments, MA organizations and Part D Sponsors should calculate the renewal rate based on the FMV of the enrollment year. We are also clarifying that our proposed and final regulations do not require an indefinite payment of 50 percent of the FMV. The final rule would permit up to 50 percent of the current FMV to be paid by an MA organization or Part D sponsor. CMS currently requires that plans inform CMS as to whether they are using independent agents. Contracts between MA organizations and Part D Sponsors, on one hand, and their independent agents and/or downstream entities on the other hand, such as Field Marketing Organizations, are not exhaustively regulated by CMS. Therefore, MA organizations and Part D sponsors may decide the duration of their contract with agents, number of applicable renewals, and the actual rate for renewals for each year, subject to the limits in this final rule.
Current regulations at §§ 422.2274(a)(4) and 423.2274(a)(4),
which we proposed to redesignate as part of paragraph (b), address the timing of plan payments, as well as recoupment of payments when a beneficiary disenrolls from a plan. Specifically, current paragraph (a)(4) states that compensation may only be paid for the beneficiary's months of enrollment during the year (January through December). Under our proposal, the new subparagraph (a) would more clearly define a plan year for purposes of compensation. The annual compensation amount covers January 1 through December 31 of each year. Our proposal also clarified that the payment made to an agent must be for January 1 through December 31 of the year and may not span calendar years. For example, a renewal payment cannot be made for the period of November 1, 2013 through October 31, 2014. These proposed revisions represented clarifications rather than new proposals and were necessary based on our findings that some plans have been paying compensation based on a rolling year cycle, rather than a calendar year cycle. Therefore, we are implementing the provision defining “plan year” and, at subparagraph (b)(3)(i), limiting payments to the months of enrollment during the calendar year, as proposed. Comments concerning this provision are discussed later in this section.
Currently, regulations at § 422.2274(a)(4)(i) permit payments to be made at one time or in installments and at any time. In order to reduce the number of payments that need to be recouped based on changes made during the annual coordinated election period (AEP), which runs from October 15 through December 7, CMS proposed, in new subparagraph (b)(3)(ii), changing the timing of payments to require that payments may not be made until January 1 of the enrollment year and must be paid in full by December 31 of the enrollment year. We stated that this proposal was appropriate given that the beneficiary's final application during the AEP becomes the effective enrollment. This would reduce the number of recoupments required when an enrollee signed more than one application during the AEP. We received several comments opposing the requirement that MA organizations and Part D plans may not make AEP payments until January 1 of the following year, but do not find these arguments sufficiently compelling to outweigh the simplification that would be gained by establishing the January deadline. We also received comments regarding our proposed requirement that payments be completed by December 31. MA organizations and industry associations stated that accurate payments, especially for enrollments effective on December 1, would be difficult to operationalize by the end of the year. However, we would expect enrollment requests for a December 1 effective date to be relatively low, as only individuals newly eligible to Medicare Advantage and those with a special election period would be able to enroll for that date. Moreover, organizations and sponsors are already required to process most post-enrollment activities within two weeks. Therefore, we continue to believe that the December 31 deadline is in the best interest of the program and are finalizing subparagraph (b)(3)(ii) as proposed.
Current regulations at §§ 422.2274(4)(ii)(A) and 423.2274(4)(ii)(A) require MA organizations and Part D sponsors to recoup compensation paid to agents when a beneficiary disenrolls from a plan within the first 3 months of enrollment. However, in sub-regulatory guidance, we have recognized several circumstances (for example, death of the beneficiary, the beneficiary moves out of the service area, the beneficiary becomes eligible to receive LIS, or the beneficiary loses Medicaid benefits) in which plans should not recoup compensation, even though the beneficiary was enrolled in the plan for less than 3 months. In such circumstances, since the disenrollment decision could not be based on agent or broker behavior, we believe it to be appropriate and in the best interest of the Medicare program for the agent to receive the compensation based on the number of months that beneficiary was enrolled in the plan. While the plan would not recoup the compensation for those months, it would recoup any compensation paid for the months after the date of disenrollment.
CMS proposed to combine current paragraphs (a)(4)(ii)(A) and (a)(4)(ii)(B) into a revised paragraph (b)(3)(iii), which included new text to require plans to recover compensation for only the months that the beneficiary is not enrolled, unless the disenrollment took place within the first 3 months. In our proposed rule, paragraph (b)(3)(iii) would require recoupment of all compensation in cases where the disenrollment was the result of agent or broker behavior. We received few but compelling comments on this proposal, which stated that it would be extremely difficult for MA organizations and Part D Sponsors to determine whether the disenrollment was a result of agent behavior, potentially resulting in compensation either being inappropriately recouped or not recouped when necessary. Based on these comments, we are not finalizing our proposal for subparagraph (b)(3)(iii) but are finalizing regulation text to state that the entire compensation must recouped if a disenrollment occurs during the first 3 months unless CMS determines that recoupment is not in the best interest of the Medicare program. We intend for this standard to be applied as we have implemented this aspect of the current regulation in past, with certain circumstances (for example, death of the beneficiary, the beneficiary moves out of the service area, the beneficiary becomes eligible to receive LIS, or the beneficiary loses Medicaid benefits) not triggering the recoupment requirement. We will continue to provide exceptions to the requirement in sub-regulatory guidance by applying the standard we are finalizing today.
We also proposed, to be codified at §§ 422.2274(h) and 423.2274(h), to codify existing sub-regulatory guidance regarding referral (finder's) fees. We released a memorandum on October 19, 2011 addressing excessive referral fees, noting that referral fees should not exceed $100. We have long been concerned that some MA organizations or Part D sponsors can offer the entire amount of compensation an agent or broker receives through only a referral while referral fees paid to others are part of the total compensation. This creates an uneven playing field within the marketplace and a clear financial incentive for the referring agent to steer beneficiaries to MA organizations or Part D sponsors that offer the higher amount, without regard for whether plan benefits meet the beneficiaries' health care needs. Therefore, we proposed to limit the amount that can be paid as a referral fee to independent, captive, and employed agents and brokers, regardless of who completes the enrollment form, to a reasonable amount, as determined by CMS, which is currently $100, for CY 2013 and CY 2014. The entire proposal concerning agent and broker compensation was discussed in the context of our concern that agents and brokers not be influenced by payments from MA organizations and Part D sponsors to steer beneficiaries to plans that do not meet the beneficiaries' needs. We note that this proposal was clearly identified in the preamble, 79 FR 1936, but the proposed regulation text, 79 FR 2060 and 2071, mistakenly included language discussing enrollee behavior and the value of health-related activities.
Furthermore, under §§ 422.2274(h)(2) and 423.2274(h)(2), CMS proposed that that referral fees paid to independent agents and brokers must be part of total compensation not to exceed the FMV for that calendar year. Although a few comments were received concerning our proposals on referral fees, we are implementing this proposal substantively as described in the preamble. However, we believe that use of the phrase “. . . while not exceeding the value of the health-related service or activity itself” was an error in the proposed regulation text. Therefore, we are finalizing text at subparagraph (h)(1) by removing that error and more clearly providing that CMS will set an annual threshold for finder fees based on a determination about amounts that would improperly incentivize agents and brokers to steer beneficiaries. We are finalizing subparagraph (h)(2) as proposed. Comment details and our responses may be found as follows.
We are finalizing the regulations with additional regulation text for a technical correction. One entity commented that the proposal eliminated §§ 422.2274(a)(1)(iv) and 423.2274(a)(1)(iv). Our proposal was not to remove these provisions concerning the applicability of compensation to third party entities and the regulation text should have included the substance of current subparagraph (a)(1)(iv). We have inserted the text from the regulation prior to the proposal at §§ 422.2274(b)(1)(iii) and 423.2274(b)(1)(iii) of this final rule.
Finally, we are not finalizing the change to the introductory language to §§ 422.2274 and 423.2274 in favor of deleting the existing introductory language (which forms the substantive basis for the new paragraph (a) definitions); the introductory language we proposed seems unnecessary to establish the scope of each regulation.
Comment:
We received more than 140 comments concerning the level of renewal payments, proposed at 35 percent. A few of the comments appreciated the simplification and briefly discussed the 35 percent but neither strongly supported the amount or strongly opposed the amount. A few commenters believed renewal compensation should increase. The vast majority (over 95 percent) of the comments did not support the proposed renewal rate of 35 percent for years two and beyond with a few clearly stating that the renewal rate should be 50 percent. Commenters included agents, brokers, plans, and industry trade associations. One major trade association representing 37 plans stated that 35 percent was overly restrictive and 50 percent is in line with industry standards, especially concerning PDPs where the 35 percent renewal would not cover the agent's costs to ensure members are in the best plans for them. The commenters provided various reasons why the 35 percent should not be implemented. The majority of commenters stated that agents play an important role in educating beneficiaries and the reduced level of compensation would result in a negative impact on beneficiaries, as it would reduce the level and quality of services provided to beneficiaries, resulting in less information and poor plan choices made by beneficiaries and would also result in agents leaving the MA marketplace. Many commenters stated that agents spend a significant amount of time in training, preparing, and testing in order to properly educate beneficiaries about plan choices. A number of commenters stated that their overhead costs (travel, postage, facility costs) were significant and a reduction in compensation would affect this aspect of their business. Commenters also stated that the lower compensation would discourage new agents from entering the MA market.
Response:
Based on the comments received, we are modifying our proposed regulations to permit the renewal payment to be up to 50 percent of FMV. MA organizations and Part D sponsors may still determine how much will be paid, up to 50 percent of the current FMV, and retain the authority to specify the details of their contracts with agents, including how many years renewal payments will be made. We believe that this increased percentage meets the statutory standard of “ensur[ing] that the use of compensation creates incentives for agents and brokers to enroll individuals in the MA plan that is intended to best meet their health care needs.”
Comment:
We received one comment from an individual who misunderstood our proposal. It appears that the commenter thought our proposal would allow two different payment options.
Response:
We have reviewed this comment and are not taking action based on an incorrect understanding of the proposal. Our proposal actually discussed two options that we considered for the renewal compensation.
Comment:
We received two comments from individuals who suggested alternative agent payment strategies. One commenter suggested modifying Medicare.gov to track agents for enrollments processed through the Web site for payment by plans. The commenter also proposed paying agents on a monthly basis, coinciding with the months the beneficiary is in a plan, eliminating the need to commission reversals. Another commenter proposed that plans submit compensation schedules to CMS for review and approval.
Response:
These recommendations entail significant changes with numerous operational implications. Therefore, we are not implementing the suggestions from these comments at this time. With respect to the comment regarding the frequency of payments, we did not propose to modify the existing regulatory permission for MA organizations and Part D sponsors to determine whether payments would be made at one time or in installments; therefore the comment is outside the scope of this proposed rule.
Comment:
We received a few comments regarding the requirement that payments be made between January 1 and December 31 of the enrollment year. One commenter supported the proposal. A few commenters did not support the January 1 date because agents would have to wait 3 to 4 months for compensation for those enrolling during the AEP. One of these commenters also noted that getting the commission assures agents that the beneficiary was enrolled. A few plans were concerned about timely payment of December 1 effective enrollees.
Response:
Our proposal is aimed at simplifying compensation while ensuring an even playing field. As explained previously, using a January 1 through December 31 payment timeframe limits the recoupment of payments made when a beneficiary makes more than one election during the AEP. Therefore, we are implementing this provision as proposed.
Comment:
We received one comment stating that regulating the payment of only independent agents was unfair and that employed agents should also be regulated.
Response:
We have reviewed this comment and have determined that the regulation of only independent agents is still appropriate. Our initial regulations were promulgated to ensure that agents/brokers do not steer beneficiaries into plans due to the agent's/broker's financial or other interest; we continue to be concerned about such steerage on the part of independent agents, since they often sell multiple products, with varying levels of compensation. In contrast, employed agents work for only one company and therefore do not have an incentive to move a member into a plan offered by a different organization
or sponsor in exchange for a higher commission.
Comment:
We received a comment from a trade association recommending that CMS consider changes from cost plans to MA plans as “like” plan changes, rather than “unlike” plan changes for compensation purposes. The commenter stated beneficiaries evaluate cost plans similar to MA plans and that treating these as unlike plan types encourages churning.
Response:
We have received this comment and declined to implement such this change from our proposal; we believe that this is outside the scope of the proposed rule. Our proposal did not address what constitutes “like” and “unlike” plan types, but instead simply referenced “like” and “unlike” plan types, using the existing regulation standards on this point, because CMS re-designated and revised certain portions of the existing regulation for simplification.
Comment:
We received a few comments regarding referral fees. One commenter recommended that the referral fee for enrollments be limited to FMV instead of $100. Other commenters requested that CMS not allow referral fees to be paid.
Response:
We reviewed these comments and are finalizing our proposal as described in the preamble to the proposed rule, with the changes to the regulation text at subparagraph (h)(1) as explained previously. Referral fees are applicable to employed, captive, and independent agents, and permitting the referral fee to be as high as the Fair Market Value (FMV) would increase the potential for steerage among different types of agents and thus plans. The $100 cap, which is required to be part of the total compensation, is an added protection to ensure financial interests of agents do result in misleading beneficiaries. Our proposal did not address whether referral fees should be permitted, only whether such fees should be capped and, if so, at what level. We do not believe that it is appropriate to prohibit or eliminate referral fees without additional rule-making that is specific on that question.
Comment:
One plan requested clarification as to whether the renewal rate of the “current” FMV meant the year in which the renewal commission is being paid.
Response:
We intend, for purposes of renewal rates, that the “current” FMV be the FMV for the enrollment year. For example, an agent would be paid 50 percent of Contract Year (CY) 2015's FMV for a renewal member who is enrolled in CY 2015.
Comment:
One plan requested clarification as to whether CMS would require payments to be retroactive or if the existing regulations would continue until member's current 6-year cycle ended. One trade organization wanted to know whether the requirements will be effective for January 1, 2015 enrollments and how the new regulations will affect members currently in the existing 6-year cycle.
Response:
As part of this final rule, the new compensation requirements will be implemented for all members for CY2015. One of CMS' intentions was to simplify the regulations and create an even playing field. We would not be able to accomplish these goals if we were to wait to implement these new requirements until all members finish their current 6-year cycle. However, we note that the final provides flexibility to MA organizations and Part D sponsors so long as payments are within the thresholds established in the rule. To the extent that an MA organization or Part D sponsor wishes to continue payment using a cycle system, negotiates that payment structure with its agents and brokers, and that cycle system complies with the limits and requirements of this final rule, the MA organization or Part D sponsor may do so.
Comment:
We received a few comments concerning recoupment of compensation when a member disenrolls within the first three months of enrollment. One plan requested a better definition of “broker behavior.” One trade association stated that there would be significant challenges in determining whether disenrollments were due to independent agent/broker conduct. The trade association is concerned that plans could face significant disputes with agents/brokers about these decisions.
Response:
We have reviewed these comments and determined that the current situation should remain unchanged based on these concerns that our proposed revisions would hamper MA organizations' and Part D sponsors' ability to determine which enrollments should be fully recouped, with the result that compensation is either inappropriately recouped or not recouped when necessary. Therefore, we are finalizing the regulation to require full recoupment of compensation when a member disenrolls within the first three months unless CMS determines that the recoupment is not in the best interests of the Medicare program. CMS will apply this standard and specify exceptions in sub-regulatory guidance. Our current guidance is consistent with this standard and will remain applicable.
Comment:
We received a few comments regarding the implementation date of the regulations. One trade association stated that it typically took nine months to make systems changes to accommodate new requirements.
Response:
We understand that systems changes may take time to implement. Because of necessary industry systems changes, and because the rule provides for a payment structure applicable by calendar year, these compensation changes do not take effect until enrollments effective January 2015. Therefore, organizations and sponsors will have approximately seven months to make such changes. Other than simplifying how FMV applies to renewal rates, the new compensation structure is similar to industry practice and present guidance. Therefore, we did not make any changes to this section of the regulation.
Comment:
One trade organization commented that many MA organizations and Part D sponsors currently operate on a “rolling year” basis, such that, if an enrollment is effective February 1, the compensation covers the period starting on February 1 and continuing through January 31 of the following year. The association said that these were well-established processes and a change could disrupt systems and require a significant re-design effort.
Response:
Our position has always been that organizations and sponsors were required under the existing rules to pay compensation on a calendar year basis, not a “rolling” year basis. When we encountered situations where organizations and sponsors have not implemented these requirements correctly, we have required the organization to adjust its processes to comply and they have done so in a timely manner. We decided to clarify this requirement in our regulations to ensure that all plans fully understand the CMS definition of an enrollment year. Therefore, we will not be making any modification based on this comment.
Comment:
One trade association stated that the NPRM appears to have eliminated the current provisions at §§ 422.2274(a)(1)(iv) and 423.2274(a)(1)(iv), which address compensation requirements for Third Party Entities.
Response:
We thank the commenter for this observation. These provisions were inadvertently eliminated from the current provisions. We have revised the regulation text accordingly.
Comment:
We received one comment from a trade association that was concerned about CMS' requirement to recover commissions if an enrollee disenrolls in the middle of the year. They suggested that CMS require MA organizations and Part D sponsors to take “commercially reasonable efforts” to recover funds.
Response:
The requirement to recover funds when a member disenrolls mid-year remains the same; we did not propose to change this requirement. Organizations and sponsors have the ability to make payments yearly, quarterly, monthly, or in other frequencies. Therefore, they could pay monthly, rather than on a yearly or quarterly basis, and thereby limit the need to recoup funds for disenrollments that occur at mid-year. Therefore, we will not be making any changes to the regulation.
Comment:
We received a few comments recommending that CMS provide a mandatory plan comparison form. Agents/Brokers would be required to fill this out and provide to the beneficiary for review.
Response:
These comments are outside the scope of our proposed rule, but we will consider this suggestion for future changes.
Comment:
We received a few comments from beneficiary advocacy groups stating that MA organizations and Part D sponsors slow down, artificially delay, or dispute the payment of compensation, which ultimately encourages agents and brokers to take their business to another plan.
Response:
These comments are outside the scope of our proposed rule, but we believe that our new requirement that compensation be paid within the enrollment year will address some of these issues.
After consideration of the public comments received, we are finalizing our proposal at §§ 422.2274(a), (b) and (h) and 423.2274(a), (b), and (h) with the following modifications as previously discussed:
• Deleting the introductory text to the regulation section.
• Raising the renewal compensation rate from 35 percent to (up to) 50 percent of the current fair market value cut-off amounts published annually by CMS.
• Removing the proposed recoupment standard for rapid disenrollments by reverting to the status quo where subregulatory guidance describes activities not triggering recoupments (rather than requiring recoupment based on “agent or broker behavior”; implementing a standard based on the best interests of the Medicare program to identify disenrollments that do not require recoupment.
• Incorporating existing regulation text about compensation to Field Marketing Organizations.
• Clarifying the CMS standard for applying the limit on referral fees.
8. Drug Categories or Classes of Clinical Concern (§ 423.120(b)(2)(v))
Section 3307 of the Affordable Care Act amended section 1860D-4(b)(3)(G) of the Act by replacing the specific criteria established under MIPPA in 2008 to identify categories or classes of Part D drugs for which all Part D drugs therein shall be included on Part D sponsor formularies. The specified criteria were replaced with the requirement that the Secretary establish criteria through notice and comment rulemaking to identify drug categories or classes of clinical concern. In addition, section 3307 of the Affordable Care Act requires the Secretary to engage in rulemaking to establish exceptions that permit a Part D sponsor to exclude from its formulary a particular Part D drug that is otherwise required to be included in the formulary in a drug category or class of clinical concern (or otherwise limit access to such a drug, including through prior authorization or utilization management). The Affordable Care Act amendments to section 1860D-4(b)(3)(G) of the Act specified that until such time as the Secretary establishes through rulemaking the criteria to identify drug categories or classes of clinical concern through rulemaking, the following categories or classes shall be identified as categories or classes of clinical concern: anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants for the treatment of transplant rejection. We proposed to implement the Affordable Care Act requirements set forth in section 1860D-4(b)(3)(G) of the Act by revising § 423.120(b)(2)(v) and (vi) to specify: (1) the criteria the Secretary will use to identify drug categories or classes of clinical concern; and (2) exceptions that permit Part D sponsors to exclude a particular Part D drug from within a category or class of clinical concern that is otherwise required to be included in the formulary (or to otherwise limit access to such a drug, including through utilization management or prior authorization restrictions). We also proposed to specify which drug categories or classes met the proposed criteria and explained the process we used for making these determinations.
We proposed to modify § 423.120(b)(2)(v) to require that, unless an exception applies, all Part D drugs within a drug category or class be included on the formulary if the drug category or class of drugs for a typical individual with a disease or condition treated by the drugs in the category or class meets both of the following criteria, as determined by CMS—
• Hospitalization, persistent or significant disability or incapacity, or death likely will result if initial administration (including self-administration) of a drug in the category or class does not occur within 7 days of the date the prescription for the drug was presented to the pharmacy to be filled; and
• More specific CMS formulary requirements will not suffice to meet the universe of clinical drug-and-disease-specific applications due to the diversity of disease or condition manifestations and associated specificity or variability of drug therapies necessary to treat such manifestations.
We were concerned that requiring essentially open coverage of certain categories and classes of drugs presents both patient welfare concerns and financial disadvantages for the Part D program as a result of increased drug prices and overutilization. We also believed that criteria for identifying drug categories and classes of clinical concern should identify only those drug categories or classes for which access cannot be adequately ensured by beneficiary protections that otherwise apply. Consequently, as we took the opportunity to propose to codify criteria for identifying categories or classes of drugs that are of clinical concern, we believed that the requirements of section 3307 of the Affordable Care Act should be implemented taking into consideration the other protections available to beneficiaries. Otherwise, we believed section 3307 of the Affordable Care Act would establish duplicative, and thus unnecessary, protections that would serve only to increase Part D costs—without any added benefit and with the possibility of added harm from misuse. Therefore, in considering whether additional protections continue to be needed under this section, we needed to take the other beneficiary access protections into account. We detailed five such protections: formulary transparency, formulary requirements, reassignment formulary coverage notices, transition supplies and notices, and the coverage determination and appeals processes. Taken together, we believed these requirements were comprehensive
enough that additional access safeguards would be needed only in those situations where a Part D beneficiary's clinical needs cannot be more efficiently met.
We received the following comments, and our response follows:
Comment:
We received strong support for our entire proposal from some commenters who agreed, as they stated, with “all of the reasons” underlying the proposal, but we received no supportive comments explicitly directed toward our proposed criteria for identifying categories and classes of clinical concern. However, we did receive significant opposition to our proposed criteria. Several commenters generally stated that the criteria themselves were flawed, much less their application to the drug categories and classes in our analysis. Although the statute did not provide individual criteria, some commenters stated that the criteria were more restrictive than statutory intent and insufficiently accounted for patient complexity. Other commenters stated that application of overly restrictive criteria set a dangerous precedent, and other commenters raised related concerns that other categories and classes of clinical concern could be eliminated in the future or that they could be incorrectly applied to other disease states whose guidelines indicate the use of these drugs. For example, many commenters expressed concern that if immunosuppressants for transplant rejection no longer received the additional protections under section 3307, patients with multiple sclerosis who use immunosuppressants may face access issues. Additionally, although it was mentioned as a source of savings in our RIA, some commenters opposed the idea that future drugs in a particular category or class, representing advances in therapy, may not be covered, believing this jeopardized beneficiary health. Indeed, many commenters stated that the application of these criteria would be life-threatening.
Response:
We thank the commenters for bringing their concerns to our attention. We attempted to embrace the principle of balancing access and cost through optimal formulary management inherent in the design of the Part D benefit in proposing to establish criteria pursuant to section 3307 of the Affordable Care Act. However, based on the comments received, we have concluded that our proposed criteria did not strike the balance among beneficiary access, quality assurance, cost-containment, and patient welfare that we were striving to achieve. Thus, we are not finalizing our proposal to establish new criteria for the categories and classes of clinical concern. Accordingly, we are maintaining the existing six categories and classes of clinical concern listed in the statute and are amending the regulation at § 423.120(b)(2)(v) to reflect that the categories and classes of clinical concern will be as specified in section 1860D-4(b)(3)(G)(iv) of the Act until we undertake rulemaking to specify criteria to identify the categories and classes of clinical concern.
During our annual formulary review and approval process, regardless of a drug's placement in a category or class of clinical concern, to the extent that a treatment guideline speaks to a specific category or class of drugs, we look for representation from that category or class of drugs on the formulary. Moreover, if the treatment guidelines address specific drugs, we would review formularies to ensure inclusion of those specific drugs. Thus, although a category or class of clinical concern is immunosuppressants for transplant rejection, to the extent that the treatment guidelines for multiple sclerosis indicate the use of immunosuppressants, we still would look for representation of these drugs on the formulary during our treatment guidelines review for multiple sclerosis.
After consideration of the public comments we received, we are finalizing a technical change to § 423.120(b)(2)(v) to reflect the existing categories and classes of clinical concern. Because the existing regulation at § 423.120(b)(2)(v) is obsolete in light of the Affordable Care Act, we are making a technical change to specify that until such time as we undertake rulemaking to establish criteria to identify, as appropriate, categories and classes of drugs for which we determine are of clinical concern, the categories and classes of clinical concern shall be as specified in section 1860D-4(b)(3)(G)(iv) of the Act.
9. Medication Therapy Management Program (MTM) Under Part D (§ 423.153(d))
Section 1860D-4(c)(2) of the Act provides that Part D sponsors, in offering Medication Therapy Management (MTM) programs, must target individuals who: (1) have multiple chronic diseases (such as diabetes, asthma, hypertension, hyperlipidemia, and congestive heart failure); (2) are taking multiple covered Part D drugs; and (3) are identified as likely to incur annual costs for covered Part D drugs that exceed a level specified by the Secretary. At the start of the Part D program, we believed that 25 percent of enrollees would qualify for MTM services. However, analysis revealed that MTM program enrollment was well below that level. In the 2010 Call Letter and subsequent regulation, we modified the criteria to reduce the variability in eligibility and level of service and to improve access to MTM services, again targeting 25 percent of enrollees. Despite these changes, MTM program participation remains very low. Moreover, additional evidence that the program improves quality and generates medical savings supports the belief that more than 25 percent of enrollees will benefit from MTM services.
We continue to see restrictive criteria, such as plan sponsors specifying a narrow list of chronic diseases or Part D drugs coupled with requiring a higher minimum number of covered drugs (for example, eight drugs versus two) for eligibility. As a result, access to MTM services remains very low with MTM program eligibility rates at less than 8 percent in 2011. In the proposed rule, we cited a number of studies which discussed the following: there may be racial disparities in meeting the eligibility criteria, the current eligibility criteria and variability are restricting access to MTM services, and MTM enrollees with certain chronic diseases, particularly those who received annual comprehensive medication reviews (CMRs), experienced significant improvements in drug therapy outcomes when compared to beneficiaries who did not receive any MTM services, and cost savings.
We believe the studies support the necessity to reduce variability and racial disparity in eligibility criteria among plans and improve access to beneficial MTM services. We proposed changes to the eligibility requirements regarding multiple chronic diseases, multiple Part D drugs, and the annual cost threshold.
a. Multiple Chronic Diseases
Under the statute, one of the three criteria that are used to target beneficiaries for MTM services is whether a Part D beneficiary has multiple chronic diseases such as diabetes, asthma, hypertension, hyperlipidemia, and congestive heart failure. We previously interpreted this language to allow sponsors to define “multiple chronic diseases” with three chronic diseases being the maximum number a plan sponsor may require for targeted enrollment. Further, sponsors are allowed to target beneficiaries with select chronic diseases, but must include at least five of the nine core chronic diseases in their criteria. This list of core chronic diseases, as updated in the 2013 Call Letter (available at
http://www.cms.gov/Medicare/Health-
Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2013.pdf
), includes hypertension, congestive heart failure, diabetes, dyslipidemia, respiratory disease, bone disease—arthritis, mental health, Alzheimer's disease, and end stage renal disease. We proposed to revise our interpretation of “multiple chronic diseases” to require that sponsors must target enrollees having two or more chronic diseases for MTM services. We also proposed to require that at least one of the chronic diseases that a beneficiary has in order to satisfy the eligibility criteria must be one of the list of core chronic diseases. In addition, we proposed to redefine the core diseases by combining hypertension and congestive heart failure under the umbrella of “cardiovascular disease,” which would also encompass congestive heart failure, acute myocardial infarction, cerebral hemorrhage and effects of stroke, vascular disease, specified heart arrhythmias, and hypertensive heart disease. The proposed list of core chronic diseases became cardiovascular disease, diabetes, dyslipidemia, respiratory disease, bone disease—arthritis, mental health, Alzheimer's disease, and end stage renal disease.
b. Multiple Part D Drugs
The second of the three statutory criteria for identifying targeted beneficiaries is whether a Part D beneficiary is taking multiple covered Part D drugs. We proposed to revise our interpretation of “multiple Part D drugs” to require that sponsors must target enrollees taking two or more Part D covered drugs for MTM services. We also proposed to restrict the flexibility previously available to sponsors by requiring that they consider any Part D covered drug. In the proposed rule, we cited literature that supported the idea that patients with multiple diseases and taking at least two drugs are more likely to have drug therapy problems and need MTM.
c. Annual Cost Threshold
The final statutory requirement for targeting Part D beneficiaries for MTM services is that the beneficiary be identified as likely to incur costs for covered Part D drugs that exceed a level specified by the Secretary. The Congress did not impose any specific requirements with respect to the cost threshold at the time the MTM criteria were passed in to law, nor has it addressed this threshold in any of the subsequent amendments to section 1860D-4(c)(2) of the Act. We previously codified a $3,000 threshold, as updated annually by the annual percentage increase in the average per capita aggregate expenditures for Part D drugs for Part D eligible individuals under § 423.104(d)(5)(iv) in the April 2010 final rule entitled, “Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs” (75 FR 19818). The threshold is currently $3,017 in 2014. However, we are concerned that there are a number of beneficiaries who need MTM, but are not currently eligible because the
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