Introductory Guide to Medicare Part C and D

Introductory Guide to Medicare Part C and D March 14, 2014 By 1 Elizabeth B. Lippincott and Emily A. Moseley 2014 by Lippincott Law Firm PLLC Contents Introduction... 3 Instructions on Using the Guide... 3 Glossary and Definitions... 4 Glossary of Acronyms... 4 Definitions... 6 Medicare Part C (Medicare Advantage)... 11 Types of Medicare Advantage Plans... 11 Regulations and Manual Chapter... 11 Coordinated Care Plans... 11 Private Fee for Service (PFFS) Plan... 12 Overview of Benefits... 12 Regulations and Manual Chapter... 12 Basic, Required Benefits... 12 Supplemental Benefits... 13 Bidding... 13 Regulations and Guidance... 13 Bidding Process... 13 Regulation of Medicare Advantage Plan Operations... 13 Eligibility and Enrollment... 13 Organization Determinations... 16 Reconsiderations and Appeals... 16 Grievances... 17 Provider Network... 18

2 Introductory Guide to Medicare Parts C and D Provider Reimbursement... 18 Medicare Part D Prescription Drug Plans... 18 Overview of Benefits... 19 Bidding... 20 Regulations and Guidance... 20 Bidding Process... 20 Plan Reimbursement Methodology... 21 Regulation of Part D Plan Operations... 21 Eligibility and Enrollment... 21 Beneficiary Premium and Late Enrollment Penalty... 23 Coverage Determinations... 23 Transition Process... 24 Redeterminations and Appeals... 24 Grievances... 24 Pharmacy Network... 25 Marketing of Medicare Advantage and Part D Plans... 25 Regulations and Manual Chapter... 25 Development, Filing, and Distribution of Marketing Materials... 25 Filing of Marketing Materials... 26 Compliance Program Requirements for Medicare Advantage Plans... 28 Monitoring and Oversight of Medicare Advantage and Part D Plans... 29 Plan Reporting... 29 Ongoing Monitoring and Audits of Plan Performance... 30 Conclusion... 30 Page 2

3 Introductory Guide to Medicare Parts C and D Introduction This Introductory Guide to the Fundamentals of Medicare Parts C and D (this "Guide") serves as a starting point for health lawyers researching questions about Medicare Part C ("Medicare Advantage" or "MA") and Part D Plans. The Guide begins with an overview of the acronyms and terminology of Medicare Parts C and D and then highlights key features of Part C and D Plan structure, bidding, payment methodology, and regulation of operational areas. Instructions on Using the Guide The high level discussion of topics included in this Guide represents the tip of the iceberg of the regulatory framework for Medicare Advantage and Part D. When using the Guide, health lawyers should recognize that more detailed requirements exist in regulations and guidance for every subject discussed and refer to primary sources for more information. Throughout the Guide, there are hyperlinks to primary sources of regulation and sub regulatory guidance contained in CMS Manuals and other materials. CMS updates materials frequently, so health lawyers should verify that any linked materials have not been revised and reissued. Additionally, please note that other sources of subregulatory guidance exist, including memos sent directly to plan sponsors from CMS. Although a limited selection of these memos is posted on CMS' website for Medicare Advantage and Part D plans, at this time, there is not a comprehensive government repository of CMS guidance to plan sponsors. Page 3

4 Introductory Guide to Medicare Parts C and D Glossary and Definitions GLOSSARY OF ACRONYMS The following are acronyms used in this Guide. Please see the definitions below for more detail. Acronym Term ACEP ADP AEP ALJ ANOC CAP CMS CTM EGHP / EGWP EOC Annual Coordinated Election Period Annual Disenrollment Period Annual Enrollment Period Administrative Law Judge Annual Notice of Change Corrective Action Plan Center for Medicare & Medicaid Services Complaints Tracking Module Employer Group Health Plan, sometimes referred to as Employer Group Waiver Plan Evidence of Coverage HCERA The Health Care and Education Reconciliation Act of 2010 HIPAA HPMS ICL IEP IRE The Health Insurance Portability and Accountability Act Health Plan Management System Initial Coverage Limit Initial Enrollment Period Independent Review Entity Page 4

5 Introductory Guide to Medicare Parts C and D LIS MA MAC MA PD MIPPA MSA PDP PFFS PPACA PPO QIC RADV SEP SNP TrOOP TRR Low Income Subsidy Medicare Advantage Medicare Appeals Council Medicare Advantage Prescription Drug Plan The Medicare Improvements for Patients and Providers Act Medicare Savings Account Prescription Drug Plan Private Fee For Service The Patient Protection and Affordable Care Act Preferred Provider Organization Qualified Independent Contractors Risk Adjustment Data Validation Special Enrollment Period Special Needs Plan True Out of Pocket Costs Transaction Reply Report Page 5

6 Introductory Guide to Medicare Parts C and D DEFINITIONS The following are defined terms used in this Guide: Term Definition Affordable Care Act Annual Disenrollment Period Annual Coordinated Election Period Annual Enrollment Period Annual Notice of Change Appeals Call Letter Capitated Payments Collective reference to PPACA, as amended by HCERA. MA and Part D enrollees have from January 1 to February 15 to disenroll from an MA plan and return to Original Medicare. Another term for the Annual Enrollment Period. The period in which Medicare beneficiaries may enroll in a plan for the upcoming year. In 2011, the enrollment period changes from November 15 through December 31 st to October 1 through December 7. The annual notice plans must send members in the fall stating any changes in health and drug coverage, costs, or services, that will become effective January 1. The term used generally to describe all of the levels of recourse a member has to challenge a plan's decision, including reconsiderations (internal appeal to an MA plan) redeterminations (internal appeal to a Part D plan), and the additional levels of external appeal available (IRE, ALJ, MAC, judicial review). The annual instructions issued in the spring by CMS providing information and operational guidance for the upcoming benefit year for plans to use for bid preparation, implementation of CMS policies and procedures, and compliance with critical program requirements. Payments made by CMS to plans based on the number of enrollees covered by a plan in a given month. Page 6

7 Introductory Guide to Medicare Parts C and D Center for Medicare & Medicaid Services Complaints Tracking Module Corrective Action Plan Coverage Determinations Creditable Coverage Evidence of Coverage Downstream Entity File and Use First Tier Entity Grievances Health Plan Management System Independent Review Entity The federal agency which administers Medicare, Medicaid, and the Children s Health Insurance Program. The system for tracking resolution of beneficiary complaints about MA or Part D plans that are reported directly to CMS. The plan of action developed by a plan sponsor and, in some cases, reviewed and approved by CMS, in response to compliance deficiencies identified by the plan or CMS. Decisions made by a Part D plan about the prescription drug benefits an enrollee is entitled to and the level of cost sharing. Prescription drug coverage that is actuarially equivalent or more generous than the standard Part D benefit. In other words, coverage that is expected to pay at least as much as the standard Part D coverage on average. The annual member booklet detailing, among other information, what benefits the plan will cover, how much members pay, and how to file an appeal. A contractor of a First Tier Entity and a subcontractor of a plan sponsor, including administrative services providers and healthcare providers, such as physicians and pharmacies. Process to file certain marketing materials which can then be used beginning five days after filing with CMS. A contractor providing administrative or health care services for an MA or Part D plan, such as a pharmacy benefit manager. Complaints that do not qualify as organization determinations, coverage determinations, or appeals of organization or coverage determinations. A CMS system used to transfer information to and from plans. For example, plan sponsors file marketing materials and receive approvals or rejections through HPMS, and CMS routinely sends guidance memos to plans through HPMS. The CMS contracted organization that reviews the redeterminations and reconsiderations made by an MA or Part Page 7

8 Introductory Guide to Medicare Parts C and D D plan sponsor. Initial Enrollment Period Low Income Subsidy MA Organizations Marketing Guidelines Marketing Materials The seven month period beginning three months before an individual becomes eligible for Original Medicare and ending three months after the month of eligibility, when a beneficiary can first enroll in an MA, MA PD or Part D plan. A subsidy from Medicare, sometimes referred to as "extra help," that provides financial assistance for low income beneficiaries who meet income and resource requirements. Generally, recipients pay reduced or no Part D plan premiums, and reduced cost sharing. An entity organized and licensed by a State as a risk bearing entity (with the exception of provider sponsored organizations receiving waivers) that is certified by CMS as meeting the MA contract requirements. CMS s interpretation of the marketing requirements and related provisions of the MA and Part D regulations. The same Marketing Guidelines constitute Chapter 3 of the Medicare Managed Care Manual and the Prescription Drug Benefit Manual. Marketing Materials include any informational materials targeted to Medicare beneficiaries that promote a plan; inform beneficiaries that they may enroll, or remain enrolled in a plan; explain the rules and benefits of enrollment; or explain how services are covered. They may include advertising, presentation materials or promotional materials supplied to third parties. They may also include letters to plan members, membership communications, or membership activities. Medicare Advantage Medicare Advantage Organization or MA Organization Medicare Advantage Prescription Drug Plan Medicare Part C or MA Plans, offered by private companies approved by Medicare and which include both Part A (Hospital Insurance) and Part B (Medical Insurance) coverage. An approved sponsor of Medicare Advantage plans A Medicare Advantage Plan that offers Medicare prescription drug coverage. Page 8

9 Introductory Guide to Medicare Parts C and D Medicare Part A Medicare Part B Medicare Part C Medicare Part D Organization Determinations Original Medicare Preferred Provider Organization Prescription Drug Plan Hospital insurance that pays for inpatient hospital stays, care in a skilled nursing facility and some home health agency services, and hospice care. Medical insurance that pays for physician services, outpatient hospital care, and some medical services not covered by Part A. Medicare Advantage or Part C plans are health plans offered by private companies, approved by Medicare, that provide both Part A (hospital insurance) and Part B (medical insurance) coverage. Medicare prescription drug coverage, either Medicare Prescription Drug Plans or Medicare Advantage Plans. Decisions made by a Medicare Advantage Plan about the benefits an enrollee is entitled to and the level of cost sharing. Coverage available under Part A and Part B through the traditional fee for service payment system. A managed care plan in which benefits are available for care delivered by providers belonging to the plan's network or by out of network providers. Term used to describe Medicare Part D Prescription Drug Plans (PDPs). Private Fee For Service A type of Medicare Advantage plan in which (before 2011) beneficiaries can go to any Medicare approved provider that accepts the plan s payment terms, whether or not the provider has a contract with the plan, and the plan pays at least what the provider would receive under Original Medicare. Reconsiderations Redeterminations Related Entity The first level of appeal of a Medicare Advantage plan's organization determination, which is administered internally by the plan. The first level of appeal of a Part D plan's coverage determination, which is administered internally by the plan. Any entity related to a plan sponsor by common ownership or Page 9

10 Introductory Guide to Medicare Parts C and D control that (1) performs management functions under contract or delegation; (2) furnishes services to enrollees; or (3) leases real property or sells materials to plan sponsor at a cost of more than $2,500 during a contract period. Risk Adjustment Data Validation Special Enrollment Period Transaction Reply Report True Out of Pocket Cost Data validation audits performed by CMS to verify that information submitted by MA organization is supported by the beneficiary patient s medical records documentation. Plans routinely undergo small scale annual audits, but selected plans are subject to additional, very extensive and resourceintensive RADV audits, which are likely to result in requests for retroactive repayment of amounts paid to the plan by CMS. A set time that a beneficiary can sign up for an MA or Part D plan (e.g. moving to a different service area). CMS s electronic response to a plan regarding enrollment transactions. TrOOP costs are prescription drug expenditures that count toward the annual out of pocket threshold that beneficiaries must reach before catastrophic drug coverage begins. Page 10

11 Introductory Guide to Medicare Parts C and D Medicare Part C (Medicare Advantage) Under Medicare Part C, 2 private companies contract with the federal government to offer Medicare medical benefits to beneficiaries. The plans, previously called Medicare+Choice, are now referred to as Medicare Advantage. CMS pays the plan sponsor on a capitated risk basis to manage each enrollee's Original Medicare benefits, which can be enhanced as described below, under the Medicare Advantage plan's approved benefit structure. Types of Medicare Advantage Plans Medicare Advantage includes several different types of plans. 3 If licensed or otherwise approved under state law, a Medicare Advantage Organization may offer multiple plans and types of plans. Medicare Advantage Organizations must offer a plan option with Part D prescription drug benefits, though Medicare Advantage medical only plans may also be offered. REGULATIONS AND MANUAL CHAPTER The regulations describing the types of Medicare Advantage plans can be found at 42 C.F.R. Section 422.4, and Chapter 1 of the Medicare Managed Care Manual provides additional details on each type of Medicare Advantage Plan. COORDINATED CARE PLANS A coordinated care plan relies on a network of providers to deliver CMSapproved benefit packages. Coordinated care plans may include mechanisms to control utilization, such as referrals from a gatekeeper and financial arrangements that offer incentives to providers to furnish high quality and cost effective care. Coordinated care plans include: Health Maintenance Organizations (HMO) Plan A Medicare Advantage HMO Plan offers a network of contracted providers. Generally, out of network benefits are available only if services are required that cannot be provided in network. Preferred Provider Organization (PPO) Plan A PPO plan also relies on a network of providers who have agreed to a contractually specified reimbursement for covered benefits, but a PPO plan must reimburse all covered benefits regardless of whether the benefits are provided within the network of providers. Page 11

12 Introductory Guide to Medicare Parts C and D Special Needs Plan (SNP) A SNP is a specialized, coordinated care, Medicare Advantage plan expressly for special needs individuals, such as individuals living in nursing homes or those with certain chronic or disabling conditions. There are also SNPs for beneficiaries eligible for both Medicare and Medicaid, known as "dual eligibles." PRIVATE FEE FOR SERVICE (PFFS) PLAN A PFFS Plan pays providers at a rate determined by the plan on a fee for service basis, either through deeming, as described below, or through negotiated contract rates. A PFFS Plan may not restrict an enrollee s choice among providers that are lawfully authorized to provide services and agree to accept the plan's terms and conditions of payment. Before 2011, PFFS plans generally could operate without a network of contracted providers. Providers were "deemed" to have accepted the plan's fees and terms if they rendered services to PFFS enrollees, as long as the plan's reimbursement to providers was at least equal to what they would receive under Original Medicare. 4 Effective in 2011, Section 162 of the Medicare Improvements for Patients and Providers Act of 2008 ( MIPPA ) (H.R. 6331), reflected in regulations at 42 C.F.R. Section 422.114(a)(3), required that individual PFFS plans operating in a service area with two or more network MA plans (coordinated care, network based MSA, or reasonable cost reimbursement plans) maintain a contracted network of providers that meets MA access to care requirements. 5 Employer sponsored PFFS plans must maintain a contracted provider network that meets access requirements, regardless of whether multiple network based plans are available in the service area. 6 Overview of Benefits REGULATIONS AND MANUAL CHAPTER The regulations governing the benefits available under Medicare Advantage plans can be found at 42 C.F.R. Part 422, Subpart C, and are further detailed in Chapter 4 of the Medicare Managed Care Manual. BASIC, REQUIRED BENEFITS Generally, Medicare Advantage plans must cover all services that are covered under Original Medicare, following national and local Medicare coverage determinations as well as Medicare coverage guidelines. 7 Plans are subject to specific caps on out of pocket spending, set annually by CMS. 8 Plan sponsors have some flexibility in structuring their benefits. In Medicare Advantage benefit packages, it is common to see outpatient services with fixed copayments, with inpatient benefits offered either with a percent coinsurance or fixed per day or per admission inpatient copayments, subject to an annual cap on out of pocket costs. In addition, Medicare Advantage benefits are generally subject to utilization management programs similar to those administered for commercial managed care Page 12

13 Introductory Guide to Medicare Parts C and D plans. Medicare Advantage plan sponsors are required to administer quality improvement programs, including chronic care management. 9 SUPPLEMENTAL BENEFITS MA Plans can add to these benefits by offering enrollees supplemental benefits and services. 10 Examples of supplemental benefits include vision care, dental benefits, and gym memberships. Bidding REGULATIONS AND GUIDANCE The regulations governing submission of bids can be found at 42 C.F.R. Part 422, Subpart F, and CMS distributes annual guidance to plans with benefit package and bid instructions, including the annual Advance Notice of Methodological Changes and Draft Call Letter and Announcement of Calendar Year Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter (for 2013). BIDDING PROCESS Approved MA Organizations submit bids to CMS no later than the first Monday in June for the following year, with an aggregate monthly bid amount for each MA plan the organization intends to offer. 11 Bids for different plan benefit packages offered by the same MA Organization must reflect substantial differences relative to other options offered by that organization. 12 CMS has the authority to negotiate with an MA Organization before approving or rejecting a bid. Regulation of Medicare Advantage Plan Operations ELIGIBILITY AND ENROLLMENT Regulations and Manual Chapter The regulations governing eligibility and enrollment for Medicare Advantage plans can be found at 42 C.F.R. Part 422, Subpart B, and Chapter 2 of the Medicare Managed Care Manual expounds on these requirements. Additionally, there is a helpful summary calendar of the entire contract year, highlighting enrollment periods, at the end of the Announcement of Calendar Year Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. Eligibility for Medicare Advantage The following is an outline of eligibility requirements that must be met for enrollment in Medicare Advantage plans: 13 Page 13

14 Introductory Guide to Medicare Parts C and D Additional requirements apply for eligibility for SNPs and Employer Group Health Plans. Page 14

15 Introductory Guide to Medicare Parts C and D Election Periods Eligible beneficiaries may enroll in Medicare Advantage, change plans, or disenroll only during specified time periods, as described below: 14 Enrollment Process In general, MA Plans must accept individuals who elect to enroll during an appropriate enrollment period. The election must meet CMS requirements regarding content and format and be approved by CMS, which can include paper enrollment forms, online enrollment applications, telephone enrollments, or enrollment through www.medicare.gov. 15 Plan sponsors must comply with specified timeframes for enrollment processing and notices of enrollment receipt, acceptance, or denial. For example, the MA Organization has seven calendar days to submit to CMS an enrollment request received from an applicant. 16 CMS will then send a Transaction Reply Report Page 15

16 Introductory Guide to Medicare Parts C and D ("TRR") indicating whether the enrollment was accepted or rejected, and the MA organization must send written notice of the decision to the applicant within ten calendar days of receipt of the TRR. 17 Disenrollment Generally, an enrollee can disenroll only during an annual or special election period. 18 There are circumstances in which an MA Organization is either required or permitted to involuntarily disenroll members, such as moving out of the service area (required) or non payment of premium (permitted), in which case the plan must follow beneficiary notice requirements. 19 ORGANIZATION DETERMINATIONS Organization determinations are decisions about the benefits an enrollee is entitled to receive and the level of cost sharing. The regulations governing standard and expedited organizational determinations for Medicare Advantage plans are found at 42 C.F.R. 422.566 through 422.576, and are expanded upon in Chapter 13 of the Medicare Managed Care Manual. Organization determinations may be in response for requests for service or requests for payment, and requests for service can be made based on standard or expedited timeframes. The following is an overview of the timeframes for decisions on organization determinations. 20 RECONSIDERATIONS AND APPEALS Reconsiderations are first level appeals to the plan following an adverse organization determination, which are further appealable to decision makers outside of the plan. The regulations governing standard and expedited organizational determinations for Medicare Advantage plans are found at 42 C.F.R. 422.566 through Page 16

17 Introductory Guide to Medicare Parts C and D 422.576, and are expanded upon in Chapter 13 of the Medicare Managed Care Manual. The timeframes for reconsideration decisions are as follows: 21 If a plan's decision on reconsideration is adverse to the enrollee, then the plan must automatically forward the case to an Independent Review Entity (IRE) for further review. 22 In the event that the IRE upholds the plan's decision, the external levels of appeal available to MA enrollees, some of which have minimum amounts in controversy, are as follows: 23 GRIEVANCES Generally, grievances are complaints about the plan that are not organization determinations or appeals of organization determinations. 24 The regulations governing grievances can be found at 42 C.F.R. 422.561 through 422.564, and more detailed discussion can be found in Chapter 13 of the Medicare Managed Care Manual. MA plans must provide a grievance process for enrollees that includes, among other things, notice to enrollees no later than 30 calendar days after receipt of a grievance. 25 Page 17

18 Introductory Guide to Medicare Parts C and D PROVIDER NETWORK As described above under Types of Medicare Advantage Plans, plan sponsors generally must provide a contracted network of credentialed providers. Sponsors of coordinated care plans (and since 2011, many PFFS plans) must create and maintain contracted networks that meet care access requirements, which are described in 42 C.F.R. 422.112 through 422.114 and Section 110 of Chapter 4 of the Medicare Managed Care Manual. MA plans must credential contracted providers initially upon contracting, and then providers must be re credentialed at least every three years. 26 CMS regulations mandate that the written contracts between MA plan sponsors and health care providers, which CMS considers to be subcontractors or first tier and downstream entities, contain certain provisions, such as audit and inspection rights and a 10 year record retention requirement. 27 The regulations governing relationships between providers and sponsors of Medicare Advantage plans can be found at 42 C.F.R Part 422, Subpart E, and Chapter 6 of the Medicare Managed Care Manual further explains these requirements. PROVIDER REIMBURSEMENT The reimbursement terms between MA plans and their contracted providers are the product of private contract negotiations, and contracted rates are typically set as a percent of Original Medicare. The Social Security Act provisions on MA plans include a "non interference clause" that provides as follows: "(iii) Noninterference. In order to promote competition under this part and part D and in carrying out such parts, the Secretary may not require any MA organization to contract with a particular hospital, physician, or other entity or individual to furnish items and services under this title or require a particular price structure for payment under such a contract to the extent consistent with the Secretary's authority under this part." 28 Generally, this means that CMS is not involved in pricing or contract discussions or disputes between MA plans and network or prospective network providers. Non contracted providers furnishing services to MA members must accept Original Medicare reimbursement rates as payment in full. 29 Medicare Part D Prescription Drug Plans Under Medicare Part D, 30 private companies contract with the federal government to offer Medicare prescription drug benefits to beneficiaries. CMS makes capitated payments to the plan sponsor to administer enrollees' benefits under the Part D plan's approved benefit structure. Page 18

19 Introductory Guide to Medicare Parts C and D Overview of Benefits Regulations and Guidance The regulations describing Medicare Part D benefits are in 42 C.F.R. Part 423, Subpart C, and additional information can be found in Chapter 5 of the Medicare Prescription Drug Benefit Manual in the annual Announcement of Calendar Year Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. Description Plan sponsors offering Medicare Part D benefits must offer a standard benefit or its actuarial equivalent and have the option of offering additional enhanced Part D benefit plans. 31 Every Part D plan must have a CMS approved formulary of covered prescription drugs. Plans are subject to specific caps on out of pocket spending, set annually by CMS. 32 Common benefit modifications and enhancements include plans without deductibles, with tiered copayments instead of coinsurance, or with generic drug benefits during the coverage gap. Beneficiaries who qualify for a Low Income Subsidy (LIS) pay lower cost sharing and lower or no premium for Part D coverage, as described in detail in Chapter 13 of the Medicare Prescription Drug Benefit Manual. 33 The following is a description of the four phases of the standard Part D benefit for 2011: Standard Part D Benefit in 2014 Coverage Gap Discount Program The Affordable Care Act created a program to close the coverage gap by requiring, among other things, that manufacturers of Part D drugs reimburse plans for fifty percent of member costs during the coverage gap. 34 In 2011 and 2012, members of standard Part D benefit plans were responsible for fifty percent coinsurance. The ACA provided for a phase in of additional costs in the coverage gap to be covered by the Part D plan, and by 2020, member coinsurance in this benefit phase will have been reduced Page 19

20 Introductory Guide to Medicare Parts C and D to twenty five percent. With respect to brand drugs, for 2013 and 2014, the Part D plan will pay 2.5 percent, and the member will be responsible for the 47.5 percent that remains after the brand drug manufacturer contributes fifty percent through the discount program. 35 For generic drugs, the Part D plan s share of the cost in the coverage gap began at a rate of seven percent in 2011 and will increase by seven percent per year until it 2020, when it will be set at twenty five percent. 36 In 2013, the Part D plan will cover twenty one percent of the cost of generics, and the member will be responsible for seventy nine percent. Low Income Subsidy (LIS) and Low Income Cost Sharing (LICS) Medicare beneficiaries meeting income and asset requirements may be eligible for two types of assistance with their Part D benefits, a premium subsidy referred to as LIS and a cost sharing subsidy referred to as LICS. Each subsidy is provided in multiple levels, depending on the individual s financial status. Full Benefit Dual Eligible beneficiaries as well as those with income at or below 135 percent of the federal poverty level receive highest level of premium subsidy, which is one hundred percent of the national low income benchmark premium amount. 37 There are three tiers of partial LIS that receive seventy five, fifty, and twenty five percent premium subsidy. 38 LIS eligible individuals are not subject to the late enrollment penalty (LEP). 39 There are three tiers of benefits for members eligible for LICS, Full Subsidy Full Benefit Dual Eligible (persons with Medicaid as well as Medicare), Full Subsidy, and Partial Subsidy. 40 This means that for each Part D benefit plan, a plan sponsor will actually be administering four benefit packages, the standard benefit plus each of the three LICS levels. Bidding REGULATIONS AND GUIDANCE The regulations governing submission of bids can be found at 42 C.F.R. Part 423, Subpart F, and CMS distributes annual guidance to plans with benefit and bid instructions, including the annual Advance Notice and the Announcement of Calendar Year Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. BIDDING PROCESS Plan sponsors and applicants submit bids to CMS no later than the first Monday in June for the following year. 41 Bids for different plan benefit packages offered by the same sponsor must reflect substantial differences relative to other options offered by that organization. 42 Page 20

21 Introductory Guide to Medicare Parts C and D Plan Reimbursement Methodology Part D plans receive reimbursement per member, per month based on the plan's approved standardized bid amount, adjusted for members' health status and risk and reduced by the amount of the member's premium for the plan. 43 CMS calculates an annual benchmark amount, or national average monthly bid amount, which is an average of standardized bids, weighted by enrollment. 44 In addition, CMS makes reinsurance payments to plans for eighty percent of drug costs for members in the catastrophic coverage phase of the Part D benefit. Finally, there may be retroactive adjustments to payments a plan received for a contract year based on a reconciliation process to evaluate prospective payments against experience as well as calculations under risk corridors. 45 Regulation of Part D Plan Operations ELIGIBILITY AND ENROLLMENT Regulations and Manual Chapter The regulations governing eligibility and enrollment for Part D plans can be found at 42 C.F.R. Part 423, Subpart B, and Chapter 3 of the Part D Prescription Drug Benefit Manual further explains these requirements. Eligibility for Part D The following is an outline of eligibility requirements that must be met for enrollment in Part D plans: 46 Election Periods Eligible beneficiaries may enroll in Part D, change plans, or disenroll only during specified time periods, as described below: 47 Page 21

22 Introductory Guide to Medicare Parts C and D Enrollment Process In general, Part D plans must accept individuals who elect the plan during an appropriate enrollment period. The enrollment form or other CMS approved mechanism, which can include online enrollment, telephone enrollment, or enrollment through www.medicare.gov, must comply with CMS instructions regarding content and format. 48 Enrolling individuals must provide information regarding coverage under other insurance, group plans, or other third party arrangements. The plan sponsor must timely process the enrollment request and provide prompt notice of acceptance or denial. For example, the Part D plan sponsor has seven calendar days to submit to CMS an enrollment request received from an applicant. 49 CMS will then send a Transaction Reply Report ("TRR") indicating whether the enrollment was accepted or rejected, and the plan sponsor must send written notice of the decision to the applicant within ten calendar days of receipt of the TRR. CMS may passively enroll individuals in limited circumstances, for example, in the case of an immediate termination of a plan. 50 In addition, CMS enrolls low income subsidy ("LIS") eligible individuals, through what is referred to as "auto" or "facilitated" enrollment. 51 Full benefit dual eligibles, beneficiaries who are eligible for comprehensive Medicaid benefits who have not opted out of Part D or enrolled in a Part D plan are generally "auto enrolled" into a plan. 52 LIS eligible beneficiaries who do not receive full Medicaid benefits and have not opted out of Part D or enrolled in a plan will generally be "facilitated enrolled" into a qualifying Part D plan. 53 Disenrollment Generally, an enrollee can only voluntarily disenroll during an annual or special election period and will remain enrolled in a Part D plan until the individual enrolls in another Part D or MA plan or voluntarily disenrolled. There are circumstances in which an MA Organization is either required or permitted to involuntarily disenroll members, Page 22

23 Introductory Guide to Medicare Parts C and D such as moving out of the service area (required) or non payment of premium (permitted), in which case the plan must follow beneficiary notice requirements. 54 BENEFICIARY PREMIUM AND LATE ENROLLMENT PENALTY Part D enrollees pay a monthly beneficiary premium, which covers the beneficiary's share (roughly twenty five percent) of the cost of standard Part D coverage after that amount is (a) adjusted in the event that the Part D plan's bid exceeded or was lower than the premium benchmark and (b) increased to cover the cost of supplemental coverage included in the plan. 55 LIS eligible beneficiaries pay a reduced premium if any. 56 An enrollee must pay a late enrollment penalty, which is added to each month's Part D beneficiary premium, if there is a continuous period of at least 63 days in which the individual was eligible for Medicare Part D but not covered under a Part D plan or another source of creditable (actuarially equivalent to Part D) drug coverage. 57 For details on creditable coverage and the late enrollment penalty, refer to Chapter 4 of the Medicare Prescription Drug Benefit Manual. COVERAGE DETERMINATIONS Coverage determinations are decisions about the prescription drug coverage a Part D enrollee is entitled to and the level of cost sharing and include, for example, requests for exceptions to a plan's formulary and requests for prior approval. The regulations governing standard and expedited coverage determinations for Part D Plans are found at 42 C.F.R. 423 Sections 566 578 and are expanded upon in Chapter 18 of the Part D Prescription Drug Benefit Manual. Each Part D plan sponsor must have standard and expedited procedures for making coverage determinations. The following is an overview of the timeframes for decisions on coverage determinations. 58 Page 23

24 Introductory Guide to Medicare Parts C and D TRANSITION PROCESS Part D plans must provide a transition supply of medications to new enrollees or enrollees affected by formulary changes if they have been prescribed drugs that are either not on the plan s formulary or that are subject to prior authorization or step therapy. 59 Members are entitled to a temporary supply of their medication during the first 90 days of their enrollment in the plan. 60 REDETERMINATIONS AND APPEALS Redeterminations are first level appeals to the plan following an adverse coverage determination, which are further appealable to decision makers outside of the plan. The regulations governing standard and expedited redeterminations and appeals for Part D plans are found at 42 C.F.R. Sections 423.580 through 423.638 (redeterminations) and 42 C.F.R. Part 423, Subpart U (external levels of appeal), and are expanded upon in Chapter 18 of the Part D Prescription Drug Benefit Manual. The timeframes for redetermination decisions are as follows: 61 If a plan's decision on reconsideration is adverse to the enrollee, then the enrollee has the option of appealing to an Independent Review Entity (IRE) for further review. 62 The external levels of appeal available to Part D enrollees, some of which have minimum amounts in controversy, are as follows: 63 GRIEVANCES Generally, grievances are complaints about the plan that are not coverage determinations or appeals of coverage determinations. 64 The regulations governing grievances can be found at 42 C.F.R. 423.560 through 423.546, and more detailed discussion is in Chapter 18 of the Part D Prescription Drug Benefit Manual. Part D plans Page 24

25 Introductory Guide to Medicare Parts C and D must provide a grievance process for enrollees that includes, among other mandates, notice to enrollees no later than 30 calendar days after receipt of a grievance. 65 PHARMACY NETWORK Part D plan sponsors must provide a contracted network of pharmacies that meets specific care access requirements, which are described in 42 C.F.R. Section 423.120 and Section 50 of Chapter 5 of the Prescription Drug Benefit Manual. In addition, under certain circumstances, out of network pharmacy access must be available. 66 Marketing of Medicare Advantage and Part D Plans Regulations and Manual Chapter Because of the risk of beneficiary confusion or manipulation, marketing is one of the most highly regulated and scrutinized functions of a MA or Part D plan sponsor. The regulations governing sales and marketing of MA and Part D plans can be found at 42 C.F.R. Part 422, Subpart V, 42 C.F.R. Part 423, Subpart V, and the Medicare Marketing Guidelines for 2012 ("Marketing Guidelines"), found in Chapter 3 of the Medicare Managed Care Manual, expound on these requirements. Because the requirements are, for the most part, the same for MA and Part D plans, this discussion will address marketing of both types of plans. Development, Filing, and Distribution of Marketing Materials The Marketing Guidelines govern virtually every detail of what marketing materials an MA or Part D plan sponsor must distribute, requirements for filing materials with CMS, how and when they are disseminated, and what content they must and must not include. DEVELOPMENT OF MARKETING MATERIALS The Marketing Guidelines contain detailed requirements on what must be included in various marketing materials, including specific disclaimers required in certain types of advertisements and other materials, as well as specifications such as font size and form numbers. 67 The definition of marketing materials covers more than advertising and includes informational materials targeted to beneficiaries, including the following: 68 General audience materials such as brochures, direct mail, newspapers, magazines, television, radio, billboards, yellow pages, or websites; Marketing representative materials such as scripts or outlines; Presentation slides; Promotional materials such as brochures, including those circulated by physicians or other third parties; Page 25

26 Introductory Guide to Medicare Parts C and D Member communications and materials including membership rules, subscriber agreements, member booklets, and wallet card instructions; Communications to members about contractual changes and changes in providers, premiums, benefits, or plan procedures; Materials used by agents and brokers; and Communications to members regarding plan policies, rules about non payment of premiums, enrollment confirmations, or other non claim specific notices.. CMS creates model materials and requires that plans use certain standardized model materials, without modification, when they are available. 69 FILING OF MARKETING MATERIALS Marketing materials must be filed with CMS through HPMS for approval before they are used by a plan sponsor, as described in Section 90 of the Marketing Guidelines. Plan sponsors are responsible for ensuring that materials comply with the Marketing Guidelines and other applicable requirements, even though they are filed with, and in some cases reviewed and approved, by CMS. It is standard for plan sponsors to use CMS' optional "File and Use" program. Materials qualified to be submitted under File and Use include general advertising that does not mention benefit and plan premium information; provider directories; standardized ANOC/EOC; formularies; certain model enrollment and member letters; and OMB approved forms. File and use materials may be used five calendar days after they are filed with CMS. 70 The following is a summary of the timeframes for CMS review of filed marketing materials: 71 Language Requirements Marketing materials must be available in any language that is the primary language of more than five percent of a plan sponsor's plan benefit package service area. 72 In addition, all plans, regardless of service area, must be able to serve non English speaking callers through their call centers. 73 Page 26

27 Introductory Guide to Medicare Parts C and D Sales and Marketing Requirements and Prohibitions The Marketing Guidelines contain numerous requirements and restrictions for sales and marketing of MA and Part D Products. The following table highlights a sampling of these specifications, with references to applicable sections of the Marketing Guidelines: Plan Sponsors Must Plan Sponsors Must Not Provide CMS with information about any studies cited in materials, 40.4 Adhere to requirements for endorsements or testimonials (e.g. "paid endorsement"), 40.7 List customer service hours of operation and toll free number and TTY information whenever a customer service number is provided, 40.8 Specify when a number given is for a licensed insurance agent/broker, 40.8.1 Adhere to specific requirements for marketing multiple lines of business, 40.11 Use hold time messages describing non health related services (e.g. life insurance), 30.10 Use of Medicare name, words or symbols in a manner suggesting government endorsement, 40.4; Appendix 2 Use absolute superlatives (e.g. "highest ranked") without supporting data, 40.4 Conduct sales activities in healthcare settings except in common areas, 70.12 Encourage or allow providers to promote particular plans, 70.12 Conduct outbound calls to new enrollees to confirm understanding of plan rules, 70.8 Market through unsolicited contacts, including door to door, telephone, or email solicitation, 70.6 Document "scope of appointment" agreed to with beneficiary before faceto face sales meeting, 70.10.3 Maintain a website that meets all CMS requirements, 100 Restrictions on Gifts and Promotional Activities Any promotional gifts, items, or activities offered to enrollees and potential enrollees by plan sponsors must be of nominal value, which is currently defined as worth $15 or less retail value, regardless of the actual cost to the plan sponsor. 74 The annual aggregate retail value of all items offered to each person must be $50 or less. 75 Gifts are subject to numerous additional restrictions, such as the requirement that they be offered to all eligible to enroll regardless of whether they enroll and that they cannot be offered in the form of cash, rebates, or gift cards that could be converted into cash. 76 Page 27

28 Introductory Guide to Medicare Parts C and D Agent and Broker Training Plan sponsors must train brokers and agents annually on Medicare rules and regulations and details of the products they sell, and the broker or agent has to receive a score of at least eighty five percent on a test regarding the rules and regulations. 77 Agent and Broker Compensation Compensation of external agents and brokers selling Medicare Advantage and Part D products is tightly regulated, and CMS sets limits on rates of initial and renewal compensation. 78 Initial compensation can be paid the first year of a beneficiary's enrollment in an MA plan, while renewal compensation (set at fifty percent of initial) is paid in the five years after that, even if the beneficiary enrolls in a different plan, either from the same or a different carrier, that is a like plan type. 79 If the enrollee moves to a different plan type (as defined by CMS), the six year compensation cycle restarts, and the agent or broker may receive an initial compensation for the first year. Under specific circumstances, including rapid disenrollment, plan sponsors must recover payments made to agents. 80 Marketing and Providers The CMS Marketing Guidelines address marketing activities involving providers. These requirements apply to the MA and Part D plan sponsors, which CMS would hold accountable for non compliant activities of providers acting on the plan sponsor s behalf. 81 Generally, providers may not steer or attempt to steer enrollees toward particular MA plans. 82 Additional restrictions on provider activities apply, such as a prohibition on providers distributing or accepting enrollment applications or acceptance of any direct or indirect compensation from a plan sponsor for enrollment activities. On the other hand, providers are permitted to provide certain information about MA plans to their patients, including the names of plans with which they contract, plan marketing materials (other than enrollment forms), and information from medicare.gov (including printed information and facilitated use of the plan comparison tool). 83 Compliance Program Requirements for Medicare Advantage Plans MA plan sponsors must maintain effective compliance and fraud, waste, and abuse programs that meet recently updated regulatory requirements. 84 In addition to the CMS regulatory requirements listed at 42 C.F.R. Sections 422.503(b)(4)(vi), Chapter 9 of the Prescription Drug Benefit Manual and Chapter 21 of the Medicare Managed Care Manual, Compliance Program Guidelines, outlines requirements and recommendations for compliance and fraud, waste, and abuse programs. A well designed and effectively implemented compliance plan must include the following seven elements: Page 28 (1) Written policies, procedures, and standard of conduct that, among other elements, articulate a commitment to comply with all applicable federal and state standards; implement compliance program operations; guide employees and others on how to deal with potential compliance issues;

29 Introductory Guide to Medicare Parts C and D identify how to communicate compliance issues to appropriate compliance personnel; describe how compliance issues are investigated and resolved. (2) The designation of a compliance officer and committee who report directly to the board of directors, the CEO, or other senior management. The board and senior management must be informed about and engaged in the compliance program. (3) Effective training and education between the compliance officer and organization employees, the CEO, and employees, board members, and subcontractors, referred to as "first tier, downstream, and related entities." This includes training upon hire and then at least annually. (4) Effective communication (ensuring confidentiality, such as an anonymous hotline), between the compliance officer and employees, the CEO and employees, board members, and subcontractors. (5) Well publicized disciplinary standards and the implementation of procedures that encourage good faith participation in the compliance program. (6) An effective system of routine monitoring and audits (both internal and, when appropriate, external), of the organization's (and subcontractors') compliance and identification of compliance issues. This should include routine data collection as well as audits. (7) An effective system and procedures for prompt response to, investigation of, and correction of compliance issues and to reduce the potential for recurrence and ongoing compliance. Appropriate corrective action must be taken, such as disciplinary action or repayment of any identified overpayments. Policies and procedures should be reviewed and revised periodically because risk areas evolve over time. Plan sponsors are responsible for ensuring that policies and procedures reflect current requirements and are effectively implemented across their organization and within their subcontractors, referred to as first tier, downstream, and related entities. In addition, plan sponsors must ensure that all plan operations are routinely monitored and that root cause analysis is conducted on any identified issues so that they can be corrected in a way that reduces the potential for recurrence. Monitoring and Oversight of Medicare Advantage and Part D Plans Plan Reporting MA and Part D plans submit numerous ad hoc and periodic reports to CMS throughout the year. Many, but not all, of these required reports are described in the CY 2012 Medicare Part C Plan Reporting Requirements Technical Specifications Document and the Medicare Part D Reporting Requirements, which are updated at least annually. Page 29