Medicare Marketing Guidelines

For Medicare Advantage Plans

, Medicare Advantage Prescription

Drug Plans, Prescription Drug Plans, Employer/Union-Sponsored

Group Health Plans, Medicare-Medicaid Plans, and Section 1876

Cost Plans

Table of Contents

(Issued: 06/10/2016)

10 – Introduction ................................................................................. 1

20 – Materials Not Subject To Marketing Review ....................................... 3

30 – Plan/Part D Sponsor Responsibilities ................................................ 5

30.1 – Limitations on Distribution of Marketing Materials and Activities .. 5

30.2 – Co-branding ......................................................................... 5

30.2.1 – Co-branding with Providers or Downstream Entities ................ 5

30.2.2 – Plan’s/Part D Sponsor’s Relationships with State Pharmaceutical

Assistance Programs (SPAP) ............................................................. 6

30.3 – Plan/Part D Sponsor Responsibility for Subcontractor Activities

and Submission of Materials for CMS Review ...................................... 6

30.4 – Anti-Discrimination ................................................................ 7

30.5 – Requirements Pertaining to Non-English Speaking Populations .... 7

30.5.1 – Multi-Language Insert ......................................................... 8

30.6 – Required Materials with an Enrollment Form ............................. 8

30.7 – Required Materials for New and Renewing Enrollees at Time of

Enrollment and Thereafter ................................................................ 9

30.7.1 – Mailing Materials to Addresses with Multiple Enrollees ........... 10

30.8 – Enrollee Referral Programs ................................................... 10

30.9 – Star Ratings Information from CMS ....................................... 11

30.9.1 – Referencing Star Ratings in Marketing Materials ................... 11

While Medicare Advantage “plans” are specific benefit packages offered by a Medicare Advantage

“organization,” in this chapter, “plan” is used both to refer to the MA plan and to the MA organization offering the

plan.

30.9.2 – Plans with an Overall 5-Star Rating ..................................... 12

30.9.3 – Low Performing Plans ........................................................ 13

40 – General Marketing Requirements ................................................... 14

40.1 – Marketing Material Identification ........................................... 14

40.1.1 – Marketing Material Identification Number for Non-English or

Alternate Format Materials.............................................................. 15

40.2 - Font Size Rule ..................................................................... 15

40.3 - Reference to Studies or Statistical Data .................................. 16

40.4 – Prohibited Terminology/Statements ....................................... 16

40.5 – Product Endorsements/Testimonials ...................................... 18

40.6 – Hours of Operation Requirements for Marketing Materials ......... 18

40.7 – Use of TTY Numbers ............................................................ 19

40.8 – Marketing of Multiple Lines of Business .................................. 19

40.8.1 – Multiple Lines of Business - General Information ................... 20

40.8.2 – Multiple Lines of Business - Exceptions ................................ 20

40.8.3 – Marketing Materials from Third Parties that Provide Non-

Benefit/Non-Health Services ........................................................... 20

40.9 – Providing Materials in Different Media Types ........................... 21

40.10 – Standardization of Plan Name Type ...................................... 22

50 – Marketing Material Types and Applicable Disclaimers ....................... 23

50.1 – Federal Contracting Disclaimer .............................................. 23

50.2 – Disclaimers When Benefits Are Mentioned .............................. 24

50.3 – Disclaimers When Plan Premiums Are Mentioned ..................... 24

50.4 – Disclaimer on Availability of Non-English Translations .............. 25

50.5 – Disclaimer on SNP Materials ................................................. 25

50.6 – Disclaimer When Cost-Sharing is Mentioned on D-SNP Materials

Targeting Potential Enrollees ........................................................... 26

50.7 – Disclaimer for Private Fee-for-Service Plans Targeting Potential

Enrollees ...................................................................................... 26

50.8 – Disclaimers for Medicare Medical Savings Accounts (MSAs)

Targeting Potential Enrollees ........................................................... 26

iii

50.9 – Disclaimer for Materials that are Co-branded with

Providers/Pharmacies .................................................................... 27

50.10 – Disclaimer on Advertisements and Invitations to Sales/Marketing

Events ......................................................................................... 27

50.11 – Disclaimer on Promoting a Nominal Gift ................................ 27

50.12 – Disclaimer for Plans Accepting Online Enrollment Requests ..... 27

50.13 – Disclaimer When Using Third Party Materials ......................... 28

50.13.1 – Disclaimer When Third Parties List a Subset of Plan Options . 28

50.14 – Disclaimer When Referencing Star Ratings Information .......... 28

50.15 – Mailing Statements ............................................................ 29

50.16 – Disclaimer for Other Formulary Documents ........................... 30

50.17 – Disclaimer When Discussing Services from Out-of-Network/Non-

Contracted Providers ..................................................................... 30

50.18 – Pharmacy/Provider Network and Formulary Disclaimers ......... 30

60 – Required Documents.................................................................... 31

60.1 – Summary of Benefits (SB) .................................................... 31

60.2 – ID Card Requirements ......................................................... 32

60.2.1 – Health Plan ID Card Requirements ...................................... 32

60.2.2 – Part D Sponsor ID Card Requirements ................................. 33

60.3 – Additional Materials Enclosed with Required Post-Enrollment

Materials ...................................................................................... 33

60.4 – Formulary and Formulary Change Notice Requirements ............ 34

60.4.1 – Abridged Formulary .......................................................... 35

60.4.2 – Comprehensive Formulary ................................................. 37

60.4.3 – Changes to Printed and Posted Formularies .......................... 38

60.4.4 – Other Formulary Documents .............................................. 38

60.4.5 – Provision of Notice to Enrollees Regarding Formulary Changes 39

60.4.6 – Provision of Notice to Other Entities Regarding Formulary

Changes ....................................................................................... 39

60.5 – Part D Explanation of Benefits ............................................... 39

60.6 – Annual Notice of Change (ANOC) and Evidence of Coverage (EOC)

................................................................................................... 40

60.7 – Other Mid-Year Changes Requiring Enrollee Notification ........... 41

70 – Promotional Activities, Rewards, Incentives, Events and Outreach ..... 41

70.1 – Promotional Activities .......................................................... 41

70.1.1 – Nominal Gifts ................................................................... 42

70.2 – Marketing of Rewards and Incentives Programs ...................... 43

70.3 – Exclusion of Meals as a Nominal Gift ...................................... 43

70.4 - Unsolicited Electronic Communication Policy ............................ 43

70.5 – Marketing through Unsolicited Contacts .................................. 44

70.6 – Telephonic Contact .............................................................. 45

70.7 – Enrollment and Verification Requirements .............................. 46

70.8 – Prospective Enrollee Educational Events ................................. 49

70.8.1 – Enrollee-Only Educational Events ........................................ 50

70.9 – Marketing/Sales Events and Appointments ............................. 50

70.9.1 – Notifying CMS of Scheduled Marketing Events ...................... 51

70.9.2 – Personal/Individual Marketing Appointments ........................ 52

70.9.3 – Scope of Appointment ....................................................... 52

70.9.4 – Beneficiary Walk-ins to a Plan or Agent/Broker Office or Similar

Beneficiary-Initiated Face-to-Face Sales Appointment ........................ 53

70.10 – PFFS Plan Provider Education and Outreach Programs ............ 54

70.10.1 – PFFS Plan Terms and Conditions of Payment Contact and

Website Fields in HPMS .................................................................. 54

70.11 – Marketing in the Health Care Setting .................................... 54

70.11.1 – Provider-Based Activities ................................................. 56

70.11.2 – Provider Affiliation Announcements ................................... 57

70.11.3 – SNP Provider Affiliation Information................................... 58

70.11.4 – Comparative and Descriptive Plan Information .................... 58

70.11.5 – Comparative and Descriptive Plan Information Provided by a

Non-Benefit/Non-Health Service Providing Third-Party ....................... 58

80 – Telephonic Activities and Scripts ................................................... 58

80.1 – Customer Service Call Center Requirements ........................... 58

80.2 – Informational Scripts ........................................................... 60

80.3 – Enrollment Scripts/Calls ....................................................... 62

80.4 – Telephone Sales Scripts (Inbound or Outbound) ...................... 63

90 – The Marketing Review Process ...................................................... 63

90.1 – Plan/Part D Sponsor Responsibilities ...................................... 63

90.2 – Material Submission Process ................................................. 63

90.2.1 – Submission of Non-English and Alternate Format Materials .... 64

90.2.2 – Submission of Websites for Review ..................................... 65

90.2.3 – Submission of Multi-Plan Materials ...................................... 66

90.2.4 – Submission of Mobile Applications ....................................... 68

90.3 – HPMS Material Statuses ....................................................... 69

90.3.1 - Approved ......................................................................... 69

90.3.2 - Disapproved ..................................................................... 69

90.3.3 - Deemed ........................................................................... 69

90.3.4 – Withdrawn ....................................................................... 70

90.3.5 – Accepted ......................................................................... 70

90.3.6 – Alternate Format, SA/LIS, and Populated Template ............... 70

90.4 - Resubmitting Previously Disapproved Pieces............................ 70

90.6 - File & Use Process ................................................................ 71

90.6.1 - Restriction on the Manual Review of File & Use Eligible Materials

................................................................................................... 71

90.6.2 – Loss of File & Use Certification Privileges ............................. 71

90.6.3 – File & Use Retrospective Monitoring Reviews ........................ 72

90.7 – Model Marketing Materials and Language ............................... 72

90.7.1 – Standardized Model Materials ............................................. 72

90.7.2 – Non-Standardized Model Materials ...................................... 73

90.7.3 – Standardized Language ..................................................... 73

90.8 - Template Materials ............................................................... 74

90.8.1 - Static Templates ............................................................... 74

90.8.2 - Standard Templates .......................................................... 75

90.8.3 - Template Materials Quality Review and Reporting of Errors .... 75

90.9 - Review of Materials in the Marketplace ................................... 76

100 – Plan/Part D Sponsor Websites and Social/Electronic Media .............. 76

100.1 – General Website Requirements ............................................ 76

100.2 – Required Content .............................................................. 77

100.2.1 – Part D Sponsor Required Content ...................................... 79

100.2.2 – Required Documents for All Plans/Part D Sponsors .............. 80

100.3 - Electronic Enrollment .......................................................... 82

100.4 – Online Formulary, Utilization Management (UM), and Notice

Requirements ............................................................................... 82

100.5 – Social Media ..................................................................... 84

100.6 – Mobile Applications ............................................................ 85

110 – Reserved .................................................................................. 85

120 – Marketing and Sales Oversight and Responsibilities........................ 85

120.1 – Compliance with State Licensure and Appointment Laws ........ 85

120.2 – Plan Reporting of Terminated Agents ................................... 85

120.3 – Agent/Broker Training and Testing ....................................... 86

120.4 - Compensation Applicability and Definitions ............................ 86

120.4.1 – General Rules Regarding Compensation ............................. 88

120.4.2 – Compensation Payment Requirements ............................... 88

120.4.3 – Compensation Recovery Requirements (Charge-backs) ........ 91

120.4.4 – Payments other than Compensation .................................. 94

120.5 – Additional Marketing Fees ................................................... 94

120.6 – Activities That Do Not Require the Use of State-Licensed

Marketing Representatives ............................................................. 94

130 - Employer/Union Group Health Plans ............................................. 95

140 – Reserved .................................................................................. 97

150 – Use of Medicare Mark for Part D Sponsors .................................... 97

150.1 – Authorized Users for Medicare Mark ..................................... 97

vii

150.2 – Use of Medicare Prescription Drug Benefit Program Mark on

Items for Sale or Distribution .......................................................... 97

150.3 – Approval to Use the Medicare Prescription Drug Benefit Program

Mark ............................................................................................ 98

150.4 – Prohibition on Misuse of the Medicare Prescription Drug Benefit

Program Mark ............................................................................... 98

150.5 – Mark Guidelines ................................................................. 99

150.5.1 – Mark Guidelines - Negative Program Mark .......................... 99

150.5.2 – Mark Guidelines - Approved Colors .................................... 99

150.5.3 – Mark Guidelines on Languages ........................................ 100

150.5.4 – Mark Guidelines on Size ................................................. 100

150.5.5 – Mark Guidelines on Clear Space Allocation ....................... 101

150.5.6 – Mark Guidelines on Bleed Edge Indicator.......................... 101

150.5.7 – Mark Guidelines on Incorrect Use .................................... 101

150.6 – Mark Guidelines for Part D Standard Pharmacy ID Card Design

................................................................................................. 102

160 – Allowable Use of Medicare Beneficiary Information Obtained from CMS

...................................................................................................... 103

160.1 – When Prior Authorization from the Beneficiary Is Not Required

................................................................................................. 104

160.2 – When Prior Authorization from the Beneficiary Is Required ... 104

160.3 – Obtaining Prior Authorization ............................................ 105

160.4 – Sending Non-plan and Non-health Information Once Prior

Authorization is Received ............................................................. 107

Appendix 1 – Definitions .................................................................... 108

Appendix 2 – Related Laws and Regulations ......................................... 114

Appendix 3 – Pharmacy Technical Help/Coverage Determinations and

Appeals Call Center Requirements ...................................................... 117

10 – Introduction

The Medicare Marketing Guidelines (MMG) implement the Centers for

Medicare & Medicaid Services’ (CMS) marketing requirements and related

provisions of the Medicare Advantage (MA, MA-PD) (also referred to as

Plan), Medicare Prescription Drug Plan (PDP) (also referred to as Part D

Sponsor), and except where otherwise specified, Section 1876 cost plans

(also referred to as Plan) rules, (i.e., Title 42 of the Code of Federal

Regulations, Parts 422, 423, and 417). These requirements also apply to

Medicare-Medicaid Plans (MMPs), except as modified or clarified in state-

specific marketing guidance for each state’s demonstration. State-specific

guidance is considered an addendum to the MMG. State-specific marketing

guidance for MMPs will be posted to http://www.cms.gov/Medicare-

Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-

Medicaid-Coordination-

Office/FinancialAlignmentInitiative/InformationandGuidanceforPlans.html.

These requirements do not apply to Program of All-Inclusive Care for the

Elderly (PACE) plans or section 1833 Health Care Pre-payment Plans unless

otherwise noted in the MMG.

The term “marketing” is referenced at Section 1851(h) and 1860 D-4 of the

Social Security Act (the Act), as well as in CMS regulations. The scope of the

definition of “marketing materials” extends beyond the public’s general

concept of advertising materials.

Pursuant to 42 CFR Section 417.428, Section 422.2260, and Section

423.2260, the following materials, while not an exhaustive list, may fall

under CMS’ definition of marketing materials:

• General audience materials, such as general circulation brochures,

direct mail, newspapers, magazines, television, radio, billboards,

yellow pages, or the Internet;

• Marketing representative materials, such as scripts or outlines for

telemarketing or other presentations;

• Presentation materials, such as slides and charts;

• Promotional materials, such as brochures or leaflets, including

materials circulated by physicians, other providers, or third-party

entities;

• Membership communication materials, including: membership rules,

subscriber agreements, enrollee handbooks, and wallet card

instructions to enrollees (e.g., Annual Notice of change (ANOC),

Evidence of Coverage (EOC));

• Communications to enrollees about contractual changes, such as

changes in providers, premiums, benefits, plan procedures;

• Communications related to membership activities (e.g., materials on

rules involving non-payment of premiums, confirmation of enrollment

or disenrollment, or non-claim specific notification information); and

• The activities of a Plan’s/Part D Sponsor’s employees, independent

agents or brokers, Third Party Marketing Organizations (TMO)

(downstream contractors), or other similar organizations that

contribute to the steering of a potential enrollee toward a specific plan

or limited number of plans, or may receive compensation directly or

indirectly from a Plan/Part D Sponsor for marketing activities, among

others.

In addition, 42 CFR Section 417.428, Section 422.2268, and Section

423.2268 define the standards for marketing. CMS’ authority for marketing

oversight, and the MMG, encompasses not only marketing materials but also

marketing/sales activities. As Plans/Part D Sponsors implement their

programs, they should consider the following guiding principles:

• Plans/Part D Sponsors are responsible for ensuring compliance with

CMS’ current marketing regulations and guidance, as well as the

Related Laws and Regulations in Appendix 2 (e.g., Section 1557 of the

Patient Protection and Affordable Care Act). This includes monitoring

and overseeing the activities of their subcontractors, downstream

entities, and/or delegated entities. If CMS finds that, the Plan/Part D

Sponsor failed to comply with applicable rules and guidance, CMS may

take compliance action, including intermediate sanctions and/or civil

money penalties.

• Plans/Part D Sponsors are responsible for full disclosure when

providing information about plan benefits, policies, and procedures.

• Plans/Part D Sponsors are responsible for documenting compliance

with all applicable marketing requirements described in the MMG.

It is important to note that the marketing guidance set forth in this

document is subject to change as policy, communications technology, and

industry marketing practices continue to evolve. Any new rulemaking or

interpretative guidance (e.g., annual Call Letter or Health Plan Management

System (HPMS) guidance memoranda) may supersede the guidance

provided in this document. While the “approved” (or “accepted”) designation

provided to submitted marketing materials does not have an expiration date,

the status remains valid only as long as the material remains compliant with

the most current law and version of the MMG. Plans/Part D Sponsors have

responsibility to review older submissions that are still in active use to

ensure that they are compliant with the latest version of the MMG, and to

resubmit those materials with the needed corrections when they are not.

Specific questions regarding a marketing material or marketing practice

should be directed to the Plan’s/Part D Sponsor’s Account Manager or

designated Marketing Reviewer.

20 – Materials Not Subject To Marketing Review

42 CFR 422.2260, 422.2262, 423.2260, 423.2262

The following types of materials are not subject to CMS marketing review,

should not be submitted in HPMS, and do not require a material ID number.

However, Plans/Part D Sponsors are still responsible for maintaining such

materials and must make them available, through HPMS or other means,

upon request.

• Provider/Pharmacy Directories (For submission requirements, MA and

Section 1876 cost plans should refer to chapter 4 of the Medicare

Managed Care Manual; Part D Sponsors should refer to Chapter 5 of

the Medicare Prescription Drug Benefit Manual.)

• HIPAA Privacy notices (which are subject to enforcement by the Office

for Civil Rights);

• OMB-approved forms/documents, except when otherwise specified by

CMS;

• Press releases that do not include any plan-specific information

(examples of plan-specific information include information about

benefits, premiums, co-pays, deductible, how to enroll, networks);

• Enrollee newsletters that do not include any plan-specific information

(examples of plan-specific information include information about

benefits, premiums, co-pays, deductible, benefits, how to enroll,

networks);

• Blank letterhead/fax coversheets/blank pages that do not include

promotional language;

• General health promotion materials that do not include any specific

plan related information (examples of general health promotion

materials include health education and disease management

materials). In general, health promotion materials should meet CMS’

definition of “educational” (Refer to section 70.8, Educational Events);

• Non-Medicare beneficiary-specific materials that do not involve an

explanation or discussion of Part D, MA, or Section 1876 cost plans

(examples of materials within this category include notice of check

return for insufficient funds, letter stating Medicare ID number

provided was incorrect, billing statements/invoices, sales, and

premium payment coupon book);

• Documents to recruit or train sales/marketing representatives;

• Medication Therapy Management (MTM) program materials (see

definition in Appendix 1);

• Ad hoc Enrollee Communications Materials (see definition in Appendix

1);

• Materials used at educational events for the education of beneficiaries

and other interested parties (also see section 70.8);

• Coordination of Benefits notifications (as provided in Chapter 14 of the

Medicare Prescription Drug Benefit Manual);

• Health Risk Assessments;

• Mail order pharmacy election forms;

• Enrollee surveys and focus groups;

• Value-Added Items and Services (refer to Chapter 4 of the Medicare

Managed Care Manual) See definition in Appendix 1;

• Documents encouraging enrollees to use preventive services;

• Mid-year Change Enrollee Notifications (see section 60.7);

• Informational Scripts;

• Marketing materials created by State government; and

• Password protected websites that only current enrollees can access;

Note: Marketing materials included on the website are still subject to

review (e.g., Plan/Part D Sponsor advertisements).

30 – Plan/Part D Sponsor Responsibilities

30.1 – Limitations on Distribution of Marketing Materials and Activities

42 CFR 422.2262(a), 423.2262(a), 422.2260, 423.2260, 422.2268(e),

423.2268(e)

Plans/Part D Sponsors cannot market for an upcoming plan year prior to

October 1. Plans/Part D Sponsors must cease current year marketing

activities to anyone other than beneficiaries who are eligible for a valid

enrollment (e.g., aging-ins, special enrollment period (SEP)) once they begin

marketing benefits for the new contract year. Current year materials may be

provided upon beneficiary request and enrollment applications may be

processed.

Plans/Part D Sponsors are prohibited from advertising outside of their

defined service area unless unavoidable. For unavoidable situations, (e.g.,

advertising in print or broadcast media with a national audience or with an

audience that includes some individuals outside of the service area, such as

a Metropolitan Statistical Area that covers two regions), Plans/Part D

Sponsors must clearly disclose their service area in the marketing materials.

Joint enterprises (see definition in Appendix 1) must market their plans

under a single name throughout a region. Joint enterprise marketing

materials may only be distributed where one or more of the contracted

Plans/Part D Sponsors creating the single entity is licensed by that State as

a risk-bearing entity or qualifies for a waiver under 42 CFR 423.410 or 42

CFR 422.372.

30.2 – Co-branding

42 CFR 422.2268(n), 423.2268(n)

Plans/Part D Sponsors must enter in HPMS any co-branding relationships,

including any changes in or newly formed co-branding relationships, prior to

marketing it. Plans/Part D Sponsors should reference the HPMS Bid User’s

Manual for instructions on entering co-branding information (see section

90.2 for information on the material submission process).

30.2.1 – Co-branding with Providers or Downstream Entities

42 CFR 422.2262(a), 422.2268(n), 423.2262(a), 423.2268(n)

Plans are prohibited from displaying the names and/or logos of co-branded

providers on the Plan’s member identification card, unless the provider

names and/or logos are related to a member’s selection of a specific

provider/provider organization, (e.g., physicians, hospitals). Part D Sponsors

are prohibited from displaying the names and/or logos of co-branded

providers/pharmacies on the Part D Sponsor’s member identification card.

Plans/Part D Sponsors that choose to co-brand with providers/pharmacies

must include on marketing materials (other than ID cards) the language in

section 50.9. Neither the Plan/Part D Sponsor nor its co-branding

providers/pharmacies, whether through marketing materials or other

communications, may imply that the co-branding partner is endorsed by

CMS, or that its products or services are Medicare-approved. Co-branded

marketing materials must be submitted to CMS by the Plan/Part D Sponsor.

Note: Consistent with the National Council for Prescription Drug

Program’s (NCPDP’s) “Pharmacy and/or Combination ID Card”

standard, the Pharmacy Benefit Manager (PBM) name may be included

on a enrollee ID card.

30.2.2 – Plan’s/Part D Sponsor’s Relationships with State Pharmaceutical

Assistance Programs (SPAP)

A Plan’s/Part D Sponsor’s logo may be used in connection with the coverage

of benefits provided under an SPAP and may contain an emblem or symbol

indicating such a relationship.

30.3 – Plan/Part D Sponsor Responsibility for Subcontractor Activities and

Submission of Materials for CMS Review

42 CFR 422.504(i), 423.505(i), 422.2262(a), 423.2262(a)

Plans/Part D Sponsors are responsible for all marketing materials used by

their subcontractors to market their plan(s). All marketing materials used by

Plans/Part D Sponsors or their subcontractors must be submitted by the

Plan/Part D Sponsor (or its designee) to CMS for review and approval (or

acceptance).

Employer group health plans should refer to section 130 of this guidance,

Chapter 9 of the Medicare Managed Care Manual, and Chapter 12 of the

Medicare Prescription Drug Benefit Manual for more guidance.

Materials created by agents or brokers that mention plan specific benefits

must be submitted by the Plan/Part D Sponsor to CMS. Materials that include

an agent’s/broker’s phone number should clearly indicate that calling the

agent/broker number will direct an individual to a licensed insurance

agent/broker.

Note: The following types of materials do not need to be submitted

into HPMS:

• Business cards that do not mention plan specific benefits

• Materials, except for websites, that only indicate the products (e.g.,

HMO, PPO, or PDP) an agent sells. Plans/Part D Sponsors must

submit agent/broker websites that reference specific MA/Part D

products in HPMS (see section 90.2 for information on the material

submission process).

This guidance in no way precludes the application by the Plans/Part D

Sponsors of more stringent rules or contractual obligations in order to

further restrict agent or broker communication and activities.

30.4 – Anti-Discrimination

42 CFR 422.110, 422.2268(c), 423.2268(c)

Plans/Part D Sponsors may not discriminate based on race, ethnicity,

national origin, religion, gender, age, mental or physical disability, health

status, claims experience, medical history, genetic information, evidence of

insurability or geographic location. Plans/Part D Sponsors may not target

beneficiaries from higher income areas or state/ imply that plans are only

available to seniors rather than to all Medicare beneficiaries. Only Special

Needs Plans (SNPs) and MMPs may limit enrollments to individuals meeting

eligibility requirements based on health and/or other status. Basic services

and information must be made available to individuals with disabilities, upon

request.

30.5 – Requirements Pertaining to Non-English Speaking Populations

42 CFR 422.111(h)(1), 422.112(a)(8), 423.128(d)(1)(iii), 422.2264(e),

423.2264(e)

All Plans’/Part D Sponsors’ call centers must have interpreter services

available to call center personnel to answer questions from non-English

speaking or limited English proficient (LEP) beneficiaries. Call centers are

those centers that receive calls from current and prospective enrollees. This

requirement is in place regardless of the percentage of non-English speaking

or LEP beneficiaries in a plan benefit package (PBP) service area.

Plans/Part D Sponsors must make the marketing materials identified in

sections 30.6, 30.7, 30.9, and the Part D Transition Letter(s) available in

any language that is the primary language of at least five (5) percent of a

Plan’s/Part D Sponsor’s PBP service area. Final populated translations of all

marketing materials must be submitted in HPMS (see section 90.2 for

material submission process).

Note: The enrollee ID card is excluded from this requirement.

30.5.1 – Multi-Language Insert

42 CFR 422.111(h), 422.2262(c), 422.2264(a) and (e), 423.128(d)

423.2262(c), 423.2264(a) and (e)

The Multi-Language Insert is a document stating, “We have free interpreter

services to answer any questions you may have about our health or drug

plan. To get an interpreter, just call us at [1-xxx-xxx-xxxx]. Someone who

speaks [language] can help you. This is a free service.” The following

languages are included on the multi-language insert: Spanish, Chinese,

Tagalog, French, Vietnamese, German, Korean, Russian, Arabic, Italian,

Portuguese, French Creole, Polish, Hindi, and Japanese. If the five (5)

percent service area threshold (See 30.5) is applicable to a language not

currently on the Multi-Language Insert, the Plan/Part D Sponsor must add

that particular language to the statement above.

Regardless of the five (5) percent service area threshold (see section 30.5),

all Plans/Part D Sponsors must include the CMS Multi-Language Insert with

the Summary of Benefits (SB), Annual Notice of Change (ANOC)/Evidence of

Coverage (EOC), and the enrollment form. Plans/Part D Sponsors have the

option to incorporate the Multi-Language Insert as part of these materials or

provide it as a separate document.

The Multi-Language Insert cannot be modified except to include additional

languages and/or to insert the Plan/Part D Sponsor logo/name.

Note: Dual SNPs (D-SNPs) that contract with states that have more

stringent language requirements must work with CMS to determine

whether those requirements can be incorporated into the CMS Multi-

Language Insert or may be met another way.

30.6 – Required Materials with an Enrollment Form

42 CFR 422.111, 422.2264, 423.128, 423.2264

The following materials are required to be included with an enrollment form:

• Star Ratings document (as specified in section 30.9),

• Summary of Benefits,

• Multi-Language Insert (see section 30.5.1)

Note: For online enrollment requests, the Plan/Part D Sponsor must

make these materials available electronically (e.g., via website links)

to the potential enrollee prior to the completion and submission of the

enrollment request.

30.7 – Required Materials for New and Renewing Enrollees at Time of

Enrollment and Thereafter

42 CFR 422.111(c)(1), 423.128(c)(1), 422.2264(a), 423.2264(a)

Plans/Part D Sponsors are required to provide the following materials for

new and renewing enrollees at the time of enrollment. The materials are

required annually thereafter except where noted.

• ANOC/EOC or EOC, as applicable (see section 60.6 for additional

information)

• Low Income Subsidy (LIS) Rider (Part D Sponsors only, see the

Medicare Prescription Drug Benefit Manual, Chapter 13, section 70.2

for additional information ,including timeframes for delivery

(http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html)

• Comprehensive formulary or abridged formulary, including information

on how the beneficiary can obtain a comprehensive formulary (Part D

sponsors only, see chapter 5 of the Medicare Prescription Drug Benefit

Manual for additional information)

• Pharmacy directory (see chapter 5 of the Medicare Prescription Drug

Benefit manual for additional information)

• Provider directory(see chapter 4 of the Medicare Managed Care manual

for additional information)

• Membership identification card (required at time of enrollment and as

needed or required by Plan/Part D Sponsor post-enrollment; see

section 60.2 for additional information)

These documents are expected to be provided to all new enrollees no later

than ten (10) calendar days from receipt of CMS confirmation of enrollment

or by the last day of the month prior to the effective date, whichever is later.

For exceptions to the 10-day requirement related to the LIS Rider, please

see Medicare Prescription Drug Benefit Manual, Chapter 13 - Premium and

Cost-Sharing Subsidies for Low-Income Individuals, 70.2 - Enrollee

Notifications. Plans/Part D Sponsors should refer to the date of the

Transaction Reply Report (TRR) that has the notification to identify the start

of the ten (10) calendar day timeframe.

30.7.1 – Mailing Materials to Addresses with Multiple Enrollees

42 CFR 422.111, 423.128, 422.2264, 423.2264

Every enrollee must receive the materials noted in section 30.7 at the time

of enrollment. Plans/Part D Sponsors may combine the mailing of these

materials to enrollees at the same address after receiving consent from all

the enrollees. Individuals in apartment buildings are only considered to be at

the “same address” if the apartment number is the same. Individuals living

in community residences, (e.g., group homes or nursing facilities), must

each receive their own materials, regardless of whether they have the same

address.

Note: Plans/Part D Sponsors may not mail one membership

identification card to an address where multiple enrollees reside; all

enrollees must receive individual membership identification cards.

30.8 – Enrollee Referral Programs

42 CFR 422.2268(a), (b), and (d), 423.2268(a), (b), and (d)

The following general guidelines apply to referral programs under which a

Plan/Part D Sponsor solicits leads from enrollees for new enrollees. These

include gifts that would be used to thank enrollees for devoting time to

encourage enrollment.

• A Plan/Part D Sponsor can ask for referrals from enrollees, including

names and mailing addresses, but cannot request phone numbers or

email addresses

• Plans/Part D Sponsors may use enrollee provided referral names and

mailing addresses to solicit potential new enrollees by conventional mail

only

• Any solicitation for leads, including letters sent from Plans/Part D

Sponsors to enrollees, cannot announce that a gift will be offered for a

referral

• Gifts must be of nominal value (refer to sections 70.1.1, 70.2, and 70.3

for additional guidance on limits for gifts provided to enrollees or

prospective enrollees)

30.9 – Star Ratings Information from CMS

42 CFR 422.2264(a)(4), 423.2264(a)(3)

Plans/Part D Sponsors must provide Star Ratings information to beneficiaries

through the standardized Star Ratings information document. The Star

Ratings information document must be distributed when the SB and/or the

enrollment form is provided to beneficiaries. The Star Ratings information

document must also be prominently posted on plan websites.

Star Ratings are generally issued in October of each year. Plans/Part D

Sponsors are required to use updated Star Ratings information within 21

calendar days of the release of the updated information.

New Plans/Part D Sponsors that do not have any Star Ratings information

are not required to provide Star Ratings information until the next contract

year. Small Plans/Part D Sponsors that do not have complete Star Ratings

information due to insufficient sample sizes for certain measures must

include the standardized Star Ratings information document with any

enrollment form and/or the SB, as described above, and must also post the

Star Ratings information document prominently on their websites.

To create the Star Ratings information document, Plans/Part D Sponsors

must download Star Ratings information from HPMS using the following

navigation path: HPMS Homepage >Quality and Performance >

Performance Metrics > Star Rating and Display Measures > Star Ratings

Marketing Template.

Plans/Part D Sponsors have the option to add their plan logo to the Star

Ratings information document. No additional alterations may occur unless

otherwise directed by CMS through instructions. Plans/Part D sponsors must

include applicable disclaimers from section 50 of the MMG.

30.9.1 – Referencing Star Ratings in Marketing Materials

42 CFR 422.2262, 422.2264, 422.2268(e), 423.2262, 423.2264,

423.2268(e)

Plans/Part D Sponsors may only reference a contract’s individual measures

in conjunction with its overall Rating (for MA-PDs), its Part C summary rating

(for MA-only contracts), or its Part D summary rating (for PDPs) in

marketing materials. Therefore, whenever individual measures are

mentioned, the Plan’s/Part D Sponsor’s overall (summary) rating must be

clearly presented with equal or greater prominence. Plans/Part D Sponsors

may not use their Star Rating in an individual underlying category or

measure to imply higher overall or summary Star Ratings in their marketing

materials. For example, a Plan/Part D Sponsor that received an overall rating

of 2-stars, and a 5-star rating in the category of customer service may not

promote itself as a “5-star plan.”

• Plans/Part D Sponsors may not use their Star Ratings in a manner that

misleads beneficiaries into enrolling in plans based on inaccurate

information

• Plans/Part D Sponsors must include the disclaimer noted in section 50.14

on materials that refer to Star Ratings

• Plans’/Part D Sponsors’ written or graphical reference to a contract’s

overall Star Rating must make it clear that the rating is “___out of five

(5) stars.” Plans/ Part D Sponsors may use letters, numbers, or a

combination of both for the rating.

• Plans/Part D Sponsors with one or more contracts that do not have the

same overall rating across contracts must not create or disseminate

materials in a way that implies that all of their contracts achieved the

same rating. Plans/Part D Sponsors must be clear regarding the rating for

each contract identified in the material.

• Plans/Part D Sponsors may direct beneficiaries to www.Medicare.gov for

more information on Star Ratings

• Plans/Part D Sponsors may only market their Star Ratings for contracts in

the geographic service area for the specific contract marketed as

specified in section 30.1-

Limitations on Distribution of Marketing Materials

and Activities

Note: Plans/Part D Sponsors are responsible for translating Star

Ratings information as specified in section 30.5. Translation of Star

Ratings information will not be considered an alteration of the

document.

30.9.2 – Plans with an Overall 5-Star Rating

42 CFR 422.2262, 422.2264, 422.2268(e), 423.2262, 423.2264,

423.2268(e)

Plans/Part D Sponsors with overall 5-star ratings may market their ability to

enroll beneficiaries through the 5-star special enrollment period

(SEP). However, they may not specifically target enrollees in poor

performing plans or direct enrollees to request an SEP.

Plans/Part D Sponsors with an overall 5-star rating have the option to

include CMS’ gold star icon on marketing materials. The icon must be

included in a way that is not misleading and makes it clear to the audience

that the 5-star rating is for a specific contract(s), as applicable. CMS’

Regional Offices will provide the gold star icon to Plans/Part D Sponsors each

Fall.

Plans/Part D Sponsors with an overall 5-star rating under a Parent

Organization with one or more contracts that do not have an overall 5-star

rating must not create or disseminate materials in a way that implies that all

of their contracts achieved this rating. Materials should list specific contracts

with overall 5-star ratings.

If a Plan/Part D Sponsor with an overall 5-star rating is evaluated as having

a rating of less than five (5) stars for the upcoming year, the Plan/Part D

Sponsor must discontinue marketing for the purpose of accepting

enrollments under the 5-star SEP by November 30 of the current year.

30.9.3 – Low Performing Plans

42 CFR 422.2262, 422.2264, 422.2268(e), 423.2262, 423.2264,

423.2268(e)

Plans/Part D Sponsors assigned a Low Performing Icon (LPI) may not

attempt to discredit or refute their LPI status by only showcasing a higher

overall Star Rating. If an MA-PD plan has been assigned an LPI, due to low

Part C and/or Part D ratings, the Plan/Part D Sponsor must clearly indicate

its LPI status when referencing its Star Rating. For example, an MA-PD plan

has a 3-star overall rating but has an LPI because of its low Part C ratings

may advertise that its overall Star Rating is 3, but it must also include that it

has an LPI for low Part C performance. In addition, the Plan/Part D Sponsor

must state that its LPI status means that it received a 2.5-star or below

summary rating in either Part C and/or Part D for the last three years. In

cases where the Plan/Part D Sponsor received an LPI due to alternating low

performance on Part C and Part D ratings, the most recent low rating must

be noted. The LPI icon must be included in all marketing materials that

reference the Plan’s/Part D Sponsor’s Star Rating. Changes are not

permitted to the icon.

Plans/Part D Sponsors cannot encourage beneficiaries to enroll based on a

claim that if the beneficiary is later dissatisfied with a plan that they can

request an SEP and change to a higher-rated plan.

If Plans/Part D Sponsors wish to respond to CMS-issued beneficiary notices,

the proposed response must be approved by CMS prior to use. Prior CMS

approval is required unless identical materials have been previously

reviewed and approved by CMS. Outreach materials may focus on the efforts

of the Plan/Part D Sponsor to improve its Star Ratings, but cannot:

• dispute the validity or importance of CMS’ Star Ratings;

• dispute the validity of the plan’s low rating; or

• state or imply that the enrollee is responsible for the plan’s poor rating

and/or needs to take specific actions for the plan’s future success.

40 – General Marketing Requirements

40.1 – Marketing Material Identification

42 CFR 422.2262, 423.2262, 422.2264, 423.2264

Plans/Part D Sponsors are required to place a unique marketing material

identification number on all marketing materials (except as indicated below)

to facilitate CMS review of and oversight of marketing materials.

The material ID is made up of two parts: (1) Plans/Part D Sponsors contract

or MCE number, (i.e., H for MA or Section 1876 cost plans, R for regional

PPO plans (RPPOs), S for PDPs, or Y for Multi-Contract Entity (MCE)

identifier) followed by an underscore; and (2) any series of alpha numeric

characters chosen at the discretion of the Plans/Part D Sponsors. Use of the

material ID on marketing materials must be immediately followed by the

status of either

approved

pending

(for websites only), or

accepted

(e.g.,

Y1234_drugx38 Approved). Please note that Plans/Part D Sponsors should

include approved statuses only after the material is approved and not when

submitting the material for review.

Unless specifically requested to do so by CMS, Plans/Part D Sponsors should

not submit non-marketing materials into HPMS. If applicable, Plans/Part D

Sponsors that are directed to submit non-marketing materials to HPMS

should not include a status after the material ID during or after submission.

The following marketing materials do not require a marketing material ID

number on them:

• The enrollee ID card (although PDP or MA-PD enrollee ID cards must

include the CMS contract number and Plan Benefit Package (PBP) number

on them)

• Envelopes, radio ads, outdoor advertisements, banner or banner-like ads,

and social media comments and posts

Note: Refer to section 90.2.3 for additional guidance on the multi-plan

material ID requirements.

40.1.1 – Marketing Material Identification Number for Non-English or

Alternate Format Materials

42 CFR 422.2264(e), 423.2264(e)

Non-English or alternate format materials must be given a unique material

ID using the method outlined above. When submitting these materials,

Plans/Part D Sponsors must designate that they are non-English or alternate

format versions in HPMS. See sections 90.2.1 and 90.3.6 for additional

information about the submission of non-English and alternate format

materials.

40.2 - Font Size Rule

42 CFR 422.2264(a), 423.2264(a)

All text included on materials, including footnotes, must be printed with a

font size equivalent to or larger than Times New Roman twelve (12)-point.

The equivalency standard applies to both the height and width of the font.

Exceptions:

• Television Ads

• ID cards

• Internal tracking numbers

• Logos/logos with taglines

• If a Plan/Part D Sponsor publishes a notice to close enrollment in the

Public Notices

section of a newspaper, the Plan/Part D Sponsor does

not need to use twelve (12)-point font and can instead use the font

normally used by the newspaper for its

Public Notices

section

Note: For internet marketing materials, the twelve (12)-point

font requirement refers to how the Plan/Part D Sponsor codes

the font for the Web page rather than how it actually appears on

the user’s screen.

40.3 - Reference to Studies or Statistical Data

42 CFR 422.2264(a)(4), 422.2268(e), 423.2264(a)(3), 423.2268(e)

Plans/Part D Sponsors may only compare their plan to another Plan/Part D

Sponsor by referencing a study or statistical data. If a Plan/Part D Sponsor

uses a non-CMS study/survey in its marketing materials, the Plan/Part D

Sponsor must include the following information, in text or as a footnote, on

marketing pieces:

• Statement that the study/survey or statistical data is not endorsed by

Medicare;

• The name of the organization sponsoring the study;

• Information about the Plan’s/Part D Sponsor’s relationship with the

entity that conducted the study; and

• The publication title, date, and page number.

Note: This information should also be included in the HPMS marketing

material transmittal comments field when submitting the document

that includes the reference. Marketing reviewers/Account Managers

may request additional information about the study/survey.

Additionally, if the marketing piece references a non-CMS award, Plans/Part

D Sponsors must:

• State that the award was not given by Medicare;

• State the plan’s official CMS Star Rating can be found at

www.Medicare.gov; and

• Give equal prominence (font size and/or screen time) to the

Medicare Star Rating information relative to other awards or

surveys mentioned.

40.4 – Prohibited Terminology/Statements

42 CFR 422.2262, 422.2264, 423.2262, 423.2264, 422.2268(e),

423.2268(e)

CMS prohibits the distribution of marketing materials that are materially

inaccurate, misleading, or otherwise make misrepresentations.

Plans/Part D Sponsors may not:

• Claim that they are recommended or endorsed by CMS, Medicare, or

the Department of Health & Human Services (DHHS).

• Use absolute superlatives (e.g., “the best,” “highest ranked,” “rated

number 1”) and/or qualified superlatives (e.g., “one of the best,”

“among the highest rank”) unless they are substantiated with

supporting data provided to CMS as part of the marketing review

process or they are used in logos/taglines. The superlatives used and

the data provided must be in context and may not mislead consumers.

For example, a Plan/Part D Sponsor that is the only plan in the area

that received a 5-star rating in customer service, but received an

overall rating of 3 stars, may not promote itself as the highest ranked

plan in a service area where other plans have a higher overall rating.

• Market that they will not disenroll individuals due to failure to pay

premiums.

• Other than the exceptions noted in section 40.3, compare their

Plan/Part D Sponsor to another Plan/Part D Sponsor by name without

written concurrence from all Plans/Part D Sponsors being compared.

This documentation must be included when the material is submitted

in HPMS.

• Use the term “free” to describe a zero dollar premium.

• Use the term “free” in conjunction with any reduction in premiums,

deductibles or cost share, including Part B premium buy-down, low-

income subsidy or dual eligibility.

Note: MSA plans may not:

• Imply that the plan operates as a supplement to Medicare.

• Use the term “network” to describe a list of contracted preferred

providers.

Plans/Part D Sponsors may:

• State that the Plan/Part D Sponsor is approved for participation in

Medicare programs and/or it is contracted to administer Medicare

benefits.

• Use the term “Medicare-approved” to describe their benefits and/or

services within their marketing materials.

• When discussing benefits, use the term “free” in conjunction with

mandatory supplemental benefits that are provided at a zero dollar

cost share for all enrollees.

40.5 – Product Endorsements/Testimonials

42 CFR 422.2264, 423.2264, 422.2268, 423.2268

Product endorsements and testimonials for marketing purposes can be

helpful in enabling beneficiaries to make informed decisions and, therefore,

are not considered misleading if they adhere to the following:

• The speaker must identify the Plan’s/Part D Sponsor’s product by

name.

• Medicare beneficiaries endorsing or promoting a Plan/Part D Sponsor

or a specific product must be current enrollees of that Plan/Part D

Sponsor.

• If an individual is paid to endorse or promote the plan or product, this

must be clearly stated (e.g., “paid endorsement”).

• If an individual, such as an actor, is paid to portray a real or fictitious

situation, the ad must clearly state it is a “Paid Actor Portrayal.”

• An endorsement or testimonial by an individual cannot use any quotes

by physicians or other health care providers.

• A contracted or employed physician or health care provider cannot

provide an endorsement or testimonial.

• An endorsement or testimonial cannot use negative testimonials about

other Plans/Part D Sponsors.

Note: Re-publication of individual users’ content or comment that

promotes a Plan’s/Part D Sponsor’s product from social media sites

(e.g., Facebook, Twitter, YouTube, LinkedIn, Scan Code, or QR Code)

is considered a product endorsement/testimonial and must adhere to

the guidance in this section.

40.6 – Hours of Operation Requirements for Marketing Materials

42 CFR 422.111(h), 422.2262(c), 423.128(d), 423.2262(c)

A Plan’s/Part D Sponsor’s hours of operation are required to be included

when any (current or prospective enrollee) customer service number is

provided, excluding ID cards and the standardized Star Ratings information

document. Similarly, a Plan/Part D Sponsor must list the hours of operation

for 1-800-MEDICARE on every material where 1-800-MEDICARE or Medicare

TTY appears (i.e., 24 hours a day/7 days a week).

Note: The hours of operation needs to only be listed once in conjunction

with the customer service number and 1-800-MEDICARE; they do not

need to be listed every time a customer service number is provided.

• The Plan/Part D Sponsor customer service number must be a toll-free

number.

• Customer service call center hours must be the same for all individuals

regardless of whether they speak another language or use assistive

devices for communication.

Refer to section 80.1 for additional guidance for customer call centers.

40.7 – Use of TTY Numbers

Section 504 of the Rehabilitation Act

A TTY number must appear in conjunction with the Plan’s/Part D Sponsor’s

customer service number in the same font size and style as the other phone

numbers except as outlined below. Plans/Part D Sponsors can use either

their own TTY number or State relay services, as long as the number

included is accessible from TTY equipment. TTY customer service numbers

must be toll-free.

Exceptions:

• Outdoor advertising (ODA) or banner/banner-like ads

• The Multi-Language Insert

• Radio ads and radio sponsorships (e.g., sponsoring an hour of public

radio)

In television ads, the TTY number may be a different font size/style than

other phone numbers to limit possible confusion.

40.8 – Marketing of Multiple Lines of Business

42 CFR 422.2268(e), (f), and (h), 423.2268(e), (f), and (h)

Plans/Part D Sponsors cannot market non-health related products to

prospective enrollees during an MA or Part D sales activity.

Plans/Part D Sponsors may provide marketing materials describing other

health-related lines of business when marketing covered plans to

prospective enrollees, provided that such materials are in compliance with

applicable State law and Federal Medicare regulations.

40.8.1 – Multiple Lines of Business - General Information

42 CFR 422.2268(e) and (f), 423.2268(e) and (f)

Plan/Part D Sponsor marketing materials sent to current enrollees describing

other health-related lines of business are expected to contain instructions

that describe how individuals may opt out of receiving such communications.

Plans/Part D Sponsors must ensure individuals (including non-enrollees) who

ask to opt out of receiving future marketing communications are not sent

such communications. In marketing multiple lines of business, Plans/Part D

Sponsors must comply with the Health Insurance Portability and

Accountability Act (HIPAA) rules (outlined generally in Appendix 2) and the

guidance in section 160 regarding the use of beneficiary information.

Plans/Part D Sponsors that advertise multiple lines of business within the

same marketing document must keep the organization’s Medicare lines of

business clearly and understandably distinct from the other lines of business.

Plans/Part D Sponsors must not include enrollment applications for

competing lines of business (e.g., MA-PD or MA plans and Medigap products)

or for other non-Medicare lines of business in mailings that combine

Medicare plan information with other product information.

40.8.2 – Multiple Lines of Business - Exceptions

42 CFR 422.2268, 423.2268

Plans/Part D Sponsors that send non-renewal and termination notices may

only provide information regarding other Medicare products (such as other

MA-PDs available in the service area) to those enrollees receiving the non-

renewal and termination notices. Plans/Part D Sponsors may include

additional materials in a separate enclosure within the same envelope.

Enrollment applications may not be provided in the same envelope with non-

renewal or termination notices.

40.8.3 – Marketing Materials from Third Parties that Provide Non-

Benefit/Non-Health Services

42 CFR 422.2268, 423.2268

Third parties that provide non-benefit/non-health services (“Non-

benefit/non-health service providing third party entities”) are organizations

or individuals that supply non-benefit related information to Medicare

beneficiaries or a Plan’s/Part D Sponsor’s membership, which is paid for by

the Plan/Part D Sponsor or the non-benefit/non-health service-providing

third-party entity.

Example A: Company XYZ promotes health and wellness and develops

materials targeted to the Medicare population.

Example B: An individual that provides summaries of Plans/Part D

Sponsors or highlights Plans/Part D Sponsors using CMS statistical

data or other research data sources available to them and offers their

services and/or materials to the Plans/Part D Sponsors. The Plan/Part

D Sponsor would distribute or allow the non-benefit/non-health

servicing third party individual to distribute the materials to their plan

membership and/or to prospective enrollees.

Example C: Materials created by organizations like the Red Cross and

American Cancer Society.

If a non-benefit/non-health service-providing third party wishes to develop

and/or provide information to a Plan’s/Part D Sponsor’s enrollees and/or

prospective enrollees, plans must review such materials and ensure

compliance with the MMG requirements prior to distributing materials to the

Plan’s/Part D Sponsor’s membership. See section 50.13.

40.9 – Providing Materials in Different Media Types

42 CFR 422.64, 422.111, 423.48, and 423.128

Plans/Part D Sponsors may provide materials using different media types

(e.g., electronic or portable media like email, CD, or DVD). However,

Plans/Part D Sponsors must receive consent prior to providing materials in

this format (i.e., individuals must opt-in) in order for the materials to satisfy

Medicare notice and disclosure requirements. When requesting consent, the

Plan/Part D Sponsor must specify to the beneficiary the media type and the

documents to be sent in such media format. After giving consent for

electronic mailings, the enrollee must be able to opt out and receive hard

copy mailings upon request.

Plans/Part D Sponsors may provide Provider and/or Pharmacy Directories

electronically without prior consent from the enrollee. Please see chapter 4

of the Medicare Managed Care manual and chapter 5 of the Medicare

Prescription Drug Benefit manual for additional information.

In addition, Plans/Part D Sponsors electing to provide any materials using

different media types must:

• Provide instructions on how and when the electronic documents may

be accessed if they are not sent directly to the enrollee. For example,

posting the document on a plan website is not sufficient, even if an

enrollee has opted into receiving electronic communications. Plans

must also provide an email or hard copy notice informing the enrollee

where the document will be posted and when the documents will be

available. See chapter 4 of the Medicare Managed Care manual and

chapter 5 of the Medicare Prescription Drug Benefit manual for

requirements specific to the Provider and Pharmacy Directories.

• Provide hard copies (excluding plan web pages) of all enrollee

materials available to enrollees upon request.

• Have safeguards in place to ensure that enrollee contact information is

current, communication materials are delivered and received timely

and appropriately, and important materials are identified in a way that

enrollees understand their importance.

• Have a process for automatic mailing of hard copies when electronic

versions or choice of media types are undeliverable (e.g., an expired

email account).

• Ensure compliance with HIPAA and privacy rules.

40.10 – Standardization of Plan Name Type

42 CFR 422.2268 (q), 423.2268 (q), sections 1851(h)(6) and 1860D-4(l)(3)

of the Social Security Act

Plans/Part D Sponsors must include the plan type in each plan’s name using

standard terminology. Plans/Part D Sponsors enter and maintain their plan

names in HPMS. Plans/Part D Sponsors must include the plan type on all

marketing materials when the plan name is mentioned.

The plan type label must be placed at the end of each plan name. For

instance, an HMO plan named “Golden Medicare Plan” would appear as

follows: “Golden Medicare Plan (HMO).” Plans/Part D Sponsors containing

the plan type at the end of the plan name (e.g., Gold Plan PFFS) are not

required to repeat the plan type in the plan name.

Inclusion of the plan type is not required throughout an entire document.

However, plans must include the plan type on the front page or at the

beginning of the document. Model documents to which the only modification

is the addition of the required plan name type will be considered a model

without modification.

50 – Marketing Material Types and Applicable Disclaimers

42 CFR 422.2262(c), 422.2264, 423.2262(c), 423.2264

The disclaimers described in this section are required, when applicable, on

all marketing materials created by the Plan/Part D Sponsor except those

noted below. Disclaimers must be prominently displayed on the material and

must be of similar font size and style (refer to section 40.2 for more

information).

Disclaimers are not required on:

• ID cards

• Call Scripts

• Banners and banner-like ads

• Envelopes

• Outdoor advertising

• Text Messages

• Social Media

Note: If a communication written for social media has the potential to

be disseminated via other mediums, disclaimers must be included. For

example, a video produced for YouTube must include disclaimers

because the video has the potential to be disseminated by other

means.

Note: Unless otherwise instructed by CMS, updates to existing disclaimers

do not require the resubmission of marketing materials.

50.1 – Federal Contracting Disclaimer

42 CFR 422.2264(c), 423.2264(c)

All marketing materials must include a contracting statement either in the

text or at the end/bottom of the piece. The statement should include the

legal or marketing name, the type of plan (e.g., HMO, PPO, PFFS, PDP), and

who the contract is with (e.g., Medicare, Federal Government, State

Medicaid program).

Plans/Part D Sponsors are responsible for creating their own disclaimer,

which meets the requirement specified in the regulation text cited above. An

example of a disclaimer is as follows:

“[Plan’s/Part D Sponsor’s legal or marketing name] is a [plan type]

with a Medicare contract. Enrollment in [Plan’s/Part D Sponsor’s legal

or marketing name] depends on contract renewal.”

Note: In addition to the exceptions noted in the introduction to section

50, radio, television, and internet banner ads do not need to include

the Federal contracting disclaimer.

50.2 – Disclaimers When Benefits Are Mentioned

42 CFR 422.111(a) and (b), 422.2264, 423.128(a) and (b), 423.2264

The following disclaimers must be used when benefit information is included

in marketing materials:

• “This information is not a complete description of benefits. Contact the

plan for more information.”

• “Limitations, copayments, and restrictions may apply.”

• “[Benefits, premiums and/or co-payments/co-insurance] may change

on January 1 of each year.”

Plans/Part D Sponsors may select the options within the brackets that are

applicable to the marketing piece. For example, if an advertisement

mentions co-payments, but does not mention premiums, the disclaimer does

not need to specify that the premium may change January 1.

50.3 – Disclaimers When Plan Premiums Are Mentioned

42 CFR 422.111(a)(2), 422.2264(a), 423.128(a)(2), 423.2264(a)

All plan materials that mention plan premium information must include the

following disclaimer:

• “You must continue to pay your Medicare Part B premium.”

This statement is required even if the plan premium is $0. This disclaimer is

not required if the Part B premium is entirely paid by rebates under the plan.

D-SNPs where the State pays the Part B premium should indicate that the

Part B premium is covered for full-dual enrollees.

50.4 – Disclaimer on Availability of Non-English Translations

42 CFR 422.2264(e), 423.2264(e)

Plans/Part D Sponsors that meet the five (5) percent threshold for language

translation must place the following alternate language disclaimer on all

marketing materials:

“This information is available for free in other languages. Please call

our customer service number at [insert customer service and TTY

numbers, and hours of operation].”

The alternate language disclaimer must be placed in both English and all

non-English languages that meet the five (5) percent threshold for the Plan

Benefit Packages (PBP) related to the document. The non-English version

must be placed below the English version and in the same font size as the

English version.

Note: ID cards are excluded from this requirement. Radio, print ads,

and post cards are only required to include the disclaimer in the same

language as the ad.

50.5 – Disclaimer on SNP Materials

42 CFR 422.4(a)(1)(iv), 422.111(b)(2)(iii), 422.2264(a)(4), 423.2264(a)(3)

SNP plans must place a disclaimer related to enrollment eligibility on any

materials targeting potential enrollees. Some examples are:

• “This plan is available to anyone with Medicare who meets the Skilled

Nursing Facility (SNF) level of care and resides in a nursing home.”

• “This plan is available to anyone with Medicare who has been

diagnosed with HIV/AIDS.”

• “This plan is available to anyone who has both Medical Assistance from

the State and Medicare.”

Plans/Part D Sponsors may not discuss numeric SNP approval scores in

marketing materials or press releases. Plans/Part D Sponsors may only

include the following information related to their NCQA SNP approval:

• “[Insert Plan Name] has been approved by the National Committee for

Quality Assurance (NCQA) to operate as a Special Needs Plan (SNP)

until [insert last contract year of NCQA approval] based on a review of

[insert Plan Name’s] Model of Care.”

50.6 – Disclaimer When Cost-Sharing is Mentioned on D-SNP Materials

Targeting Potential Enrollees

42 CFR 422.4(a)(1)(iv), 422.111(b)(2)(iii), 422.2264, 423.2264

The following disclaimer must be on D-SNP materials targeting potential

enrollees that mention cost-sharing information. The disclaimer is not

required on materials for beneficiaries residing in the territories.

“[Premium, co-pays, co-insurance, and deductibles] may vary based

on the level of Extra Help you receive. Please contact the plan for

further details.”

50.7 – Disclaimer for Private Fee-for-Service Plans Targeting Potential

Enrollees

PFFS materials targeting potential enrollees must include the following

disclaimer:

“A Private Fee-for-Service plan is not Medicare supplement insurance.

Providers who do not contract with our plan are not required to see

you except in an emergency.”

50.8 – Disclaimers for Medicare Medical Savings Accounts (MSAs) Targeting

Potential Enrollees

42 CFR 422.111(b)(2), 422.2264(a)(4), 423.2264(a)(3)

MSA materials targeting potential enrollees must include the following

disclaimers:

• “MSA Plans combine a high deductible Medicare Advantage Plan and a

trust or custodial savings account (as defined and/or approved by the

IRS). The plan deposits money from Medicare into the account. You

can use this money to pay for your health care costs, but only

Medicare-covered expenses count toward your deductible. The amount

deposited is usually less than your deductible amount, so you

generally have to pay out-of-pocket before your coverage begins.”

• “Medicare MSA Plans don’t cover prescription drugs. If you join a

Medicare MSA Plan, you can also join any separate Medicare

Prescription Drug Plan.”

• “There are additional restrictions to join an MSA plan, and enrollment

is generally for a full calendar year unless you meet certain

exceptions. Those who disenroll during the calendar year will owe a

portion of the account deposit back to the plan. Contact the plan at

[insert customer service and TTY] for additional information.”

50.9 – Disclaimer for Materials that are Co-branded with

Providers/Pharmacies

42 CFR 422.2268(n), 423.2268(n)

Plans/Part D Sponsors that enter into co-branding relationships with network

providers/pharmacies must include the following disclaimer:

“Other <Pharmacies/Physicians/Providers> are available in our

network.”

50.10 – Disclaimer on Advertisements and Invitations to Sales/Marketing

Events

42 CFR 422.2268(e) and (o), 423.2268(e) and (o)

Advertisements and invitations to sales/marketing events (in any form of

media) used to invite individuals to attend a group session with the

possibility of enrolling those individuals must include the following

statements on marketing materials:

• “A sales person will be present with information and applications.”

• “For accommodation of persons with special needs at sales meetings

call <insert phone and TTY number>.”

50.11 – Disclaimer on Promoting a Nominal Gift

42 CFR 422.2268(b), 423.2268(b)

Plans/Part D Sponsors must include a written statement on all marketing

materials promoting drawings, prizes or any promise of a free gift that there

is no obligation to enroll in the plan. For example:

• “Eligible for a free drawing and prizes with no obligation,” or

• “Free drawing without obligation.”

50.12 – Disclaimer for Plans Accepting Online Enrollment Requests

42 CFR 422.2262(c), 423.2262(c)

Plans/Part D Sponsors accepting enrollment requests through their Online

Enrollment Center (OEC) must state the following disclaimer on their

websites:

“Medicare beneficiaries may also enroll in <plan name> through the

CMS Medicare Online Enrollment Center located at

http://www.medicare.gov.”

50.13 – Disclaimer When Using Third Party Materials

42 CFR 422.2264, 423.2264

CMS does not review materials developed by a non-benefit/non-health

service providing third-party entity that is not affiliated or contracted with

the Plan/Part D Sponsor. An affiliation is defined as a mutual agreement of

understanding (includes, but is not limited to parent organization

relationships). Plans/Part D Sponsors choosing to provide marketing

materials and/or services created by non-benefit/non-health service

providing third-party entities must include the following disclaimer on all

materials:

“Medicare has neither reviewed nor endorsed this information.”

The disclaimer must be prominently displayed at the bottom center of the

first page of the material, or in the case of a website, on each page, and be

a similar font size and style as the message.

50.13.1 – Disclaimer When Third Parties List a Subset of Plan Options

42 CFR 422.2264, 423.2264

Plans/Part D Sponsors must ensure that materials developed by a third-

party providing information on a subset of plan choices that lists, compares,

or names available plans, must prominently display the following disclaimer

on all materials:

“This is not a complete listing of plans available in your service area.

For a complete listing please contact 1-800-MEDICARE (TTY users

should call 1-877-486-2048), 24 hours a day/7 days a week or consult

www.medicare.gov.”

50.14 – Disclaimer When Referencing Star Ratings Information

42 CFR 422.2264, 423.2264

Plans/Part D Sponsors must include the following disclaimer on all materials

referencing Star Ratings information:

“Medicare evaluates plans based on a 5-star rating system. Star

Ratings are calculated each year and may change from one year to the

next.”

50.15 – Mailing Statements

42 CFR 422.2268(e), 422.2272(b), 423.2268(e), 423.2272(b)

To ensure that beneficiaries can quickly and easily identify the contents of a

Plan’s/Part D Sponsor’s mailing, all mailings to prospective or current

beneficiaries must prominently display one of the following five statements,

verbatim, on the front of the envelope. If no envelope is being sent, the

disclaimer must be on the mailing itself. Plans/Part D Sponsors may meet

this requirement using ink stamps or stickers, in lieu of pre-printed

statements. Any delegated or sub-contracted entities and downstream

entities that conduct mailings on behalf of a Plan/Part D Sponsor must

comply with this requirement.

• Advertising pieces – “This is an advertisement”

• Plan information other than a mailing with the Annual Notice of

Change – “Important plan information”

• Plan information when a mailing with the Annual Notice of

Change – “Important information about changes to your

Medicare drug and health plan” (remove either “drug” or “health”

if not applicable)

• Health and wellness information – “Health and wellness or

prevention information”

• Non-health or non-plan information - “Non-health or non-plan

related information” (see section 160.4 for examples)

Plans/Part D Sponsors must use these statements.

In addition, Plans/Part D Sponsors must include their plan name or logo on

every envelope to current and prospective enrollees (either on or visible

from the front of the envelope, or on the mailing when no envelope

accompanies the mailer).

Plans/Part D Sponsors are not required to include a material ID on

envelopes; however all envelopes must be submitted to HPMS with an

associated marketing material ID number. CMS does not require

resubmission of envelopes based only on a change in the envelope size. If a

plan uses the same mailing statement on three (3) different mailing

packages (e.g., 8 x 12 envelope, letter size envelope, and box) the envelope

with each mailing statement only needs to be submitted once, provided the

required mailing statement remains unchanged and additional information is

not included.

50.16 – Disclaimer for Other Formulary Documents

42 CFR 423.128(a) and (b)

The following disclaimer must be displayed prominently on the cover of other

formulary documents referenced in section 60.4.4:

“This is not a complete list of drugs covered by our plan. For a complete

listing, please call <Customer Service Phone and TTY Numbers/> or visit

<website address>”.

50.17 – Disclaimer When Discussing Services from Out-of-Network/Non-

Contracted Providers

42 CFR 422.2264

In general, Plans should educate their enrollees when seeking services from

Out-of-network/Non-contracted providers. All PPO plans must include the

following disclaimer on marketing materials:

Out-of-network/non-contracted providers are under no obligation to

treat <Plan/Part D Sponsor> members, except in emergency

situations. For a decision about whether we will cover an out-of-

network service, we encourage you or your provider to ask us for a

pre-service organization determination before you receive the service.

Please call our customer service number or see your Evidence of

Coverage for more information, including the cost-sharing that applies

to out-of-network services.

50.18 – Pharmacy/Provider Network and Formulary Disclaimers

42 CFR 422.111(a) and (b), 423.128(a) and (b)

The following disclaimer must be included on materials whenever formularies

and/or provider/pharmacy networks are mentioned:

• “The [Formulary, pharmacy network, and/or provider network] may

change at any time. You will receive notice when necessary.”

Plans/Part D Sponsors may include only the relevant elements in the

brackets.

Part D Sponsors with limited access to preferred cost sharing pharmacies

must include the following disclaimer on materials that reference preferred

cost sharing pharmacy networks and/or preferred cost sharing benefits:

• “<insert organization/plan name>’s pharmacy network offers limited

access to pharmacies with preferred cost sharing in <insert geographic

area type(s) and state(s) for which plan is an outlier)>. The lower

costs advertised in our plan materials for these pharmacies may not be

available at the pharmacy you use. For up-to-date information about

our network pharmacies, including pharmacies with preferred cost

sharing, please call <insert Member Services phone number and TTY>

or consult the online pharmacy directory at <insert website>.”

60 – Required Documents

60.1 – Summary of Benefits (SB)

42 CFR 422.111(b)(2), 423.128(b)(2)

Beginning CY 2017, HPMS will no longer generate the SB. Plans/Part D

Sponsors must develop their own SB based on their bid data in HPMS and

within the parameters of CMS’ SB guidance. The required data elements for

the SB are provided in the SB guidance memo. Plans/Part D Sponsors must

include the SB when providing an enrollment form and upon an enrollee’s

request. Additionally, Plans/Part D Sponsors must provide the multi-

language insert any time they distribute an SB (see section 30.5.1).

Medicaid Benefits:

D-SNPs must provide each prospective enrollee prior

to enrollment with a comprehensive written statement that

describes:

- The benefits that the individual is entitled to under Title XIX

(Medicaid);

- The cost-sharing protections that the individual is entitled to under

Title XIX (Medicaid); and

- The description of the benefits and cost-sharing protections that are

covered under the D-SNP.

The SB must be submitted in HPMS as one document under the File & Use

process. SBs may not be submitted as a template (see section 90.2 for

information on the material submission process).

Plans/Part D Sponsors offering more than one plan may describe several

plans in the same SB document by displaying the benefits for different plans.

60.2 – ID Card Requirements

42 CFR 417.427, 422.111(i), 423.120(c)

All Plans/Part D Sponsors must create ID cards following the National Council

for Prescription Drug Program (NCPDP) or Workgroup for Electronic Data

Interchange (WEDI) standards.

Combination health and drug plan ID cards must follow the WEDI standard

and must include the required information in sections 60.2.1 and 60.2.2

below.

All Plans/Part D Sponsors must issue and reissue (as appropriate) enrollee

ID cards that enrollees may use to access covered services under the plan.

ID cards must include:

• The Plan’s/Part D Sponsor’s website address

• The Plan’s/Part D Sponsor’s customer service number

• The CMS contract number/PBP number

Plans/Part D Sponsors may not use the social security number (SSN) or

Healthcare Insurance Claim Number (HICN) as the enrollee identification

number on the ID card.

ID cards are not required to include:

• The marketing material identification number

• Hours of operation of the customer service center

• Disclaimers noted in section 50

• Health Plan Identification Number (HPID) (for more information on

HPID, review the regulations published by CMS’ Office of E-Health

Standards and Services (CMS-0040-F). 77 Fed. Reg. 54664 (Sept.

5, 2012), as corrected 77 Fed. Reg. 60629 (Oct. 4, 2012))

(See section 30.2.1 regarding co-branding requirements related to ID

cards.)

60.2.1 – Health Plan ID Card Requirements

Other than exceptions cited in section 60.2, the health plan enrollee ID card

(for MA or Section 1876 cost plans) must meet the standards for medical ID

cards in the most recent version of the WEDI Health Identification Card

Implementation Guide. Visit www.wedi.org to find the Guide.

PPO and PFFS Health plan ID cards must also include the phrase “Medicare

limiting charges apply.”

60.2.2 – Part D Sponsor ID Card Requirements

Other than any exceptions cited in section 60.2, the Part D Sponsor enrollee

ID card must meet the most recent version of the NCPDP’s “Pharmacy

and/or Combination ID Card” standard. This standard is based on the

American National Standards Institute ANSI INCITS 284-1997 standard

titled Identification Card – Health Care Identification Cards.

The front of the Part D Sponsor ID Card must include the Medicare

Prescription Drug Benefit Program Mark (see section 150 for more

information).

60.3 – Additional Materials Enclosed with Required Post-Enrollment Materials

42 CFR 422.111, 423.128

Unless otherwise directed, Plans/Part D Sponsors are permitted to enclose

other materials related to benefits or plan operations in their post-

enrollment packages (e.g., health education newsletters, Medication Therapy

Management Program (MTMP) materials, mail service forms for Part D

drugs, etc.).

Informational materials that are enclosed with the post-enrollment mailing

must be:

• Distinct (e.g., folded, different color pages, tabbed) from the required

document within the mailing envelope. All documents must be distinct

if binding additional materials with required documents.

• These materials must comply with all relevant laws and regulations,

and may not include materials advertising additional products such as

Medigap by the Plan/Part D Sponsor.

Note: Materials, other than those described in this section, may not be

included in the ANOC/EOC mailing unless otherwise specified (e.g.,

ANOC/EOC instructions).

60.4 – Formulary and Formulary Change Notice Requirements

42 CFR 423.120(b)(5), 423.128 (b)(4), 423.2262(a), 423.2268(e)

Part D Sponsors must provide a list of drugs, known as a formulary, to

enrollees at the time of enrollment and at least annually thereafter. While

the print version of the formulary may be abridged, each Part D Sponsor

must provide a comprehensive formulary on its website. See Chapter 6 of

the Prescription Drug Benefit Manual for program guidance regarding

formularies, change notices, and utilization management

(http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html).

Part D Sponsors must ensure that each formulary marketed for a specific

plan is consistent with the HPMS formulary file approved by CMS for that

plan:

• Each covered drug must be displayed at the correct cost-sharing tier

and with the approved utilization management edits (i.e., prior

authorization, step therapy or quantity limits)

• The formulary drug category and class must be consistent

• The applicable HPMS approved formulary file submission ID number,

which is the HPMS formulary submission ID number of the approved

formulary that is being marketed, and version number must be

included

• Indicate when the document and search tool (if available) was last

updated by including the phrase, “Updated MM/YYYY” or “No changes

made since MM/YYYY”

Any drug adjudicated as a formulary drug at the point of sale must be

included in the Part D Sponsors’ marketing materials. This applies to drugs

that exist on the approved HPMS formulary as well as drugs covered as Part

D formulary enhancements to the approved formulary. Generally, these

drugs are expected to relate to newly approved brand or generic drugs

(including new formulations and strengths) that do not currently reside on

the Formulary Reference File (FRF), but that would likely be added during

subsequent FRF updates. These marketed formulary drug enhancements

must be added to the HPMS formulary once the drugs are represented on

the FRF.

A Part D Sponsor may market enhancements (such as adding a newly

available drug to the formulary), but not negative changes, to its formulary

prior to receiving CMS approval. For more details, see Chapter 6 of the

Medicare Prescription Drug Benefit Manual, section 30.3

(http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html).

In the event that a marketing discrepancy is identified, the Part D Sponsor

must continue to cover the drug(s) at the more favorable cost share or with

less restrictive utilization management for the affected enrollee (as defined

in 42 CFR 423.100) through the end of the contract year.

60.4.1 – Abridged Formulary

42 CFR 423.128, 423.2262(c), 423.2268(e)

Part D Sponsors are expected to provide an abridged formulary document

that includes at a minimum:

• Sponsor Name on cover page

• “<Year> Formulary (List of Covered Drugs)” on cover page

• “PLEASE READ: THIS DOCUMENT CONTAINS INFORMATION ABOUT THE

DRUGS WE COVER IN THIS PLAN” on cover page

• Advise enrollees that the document includes a partial list of drugs; that

enrollees can visit the website or call the plan for a complete list of

covered drugs

• Contact information on both the front and back cover pages

• The following statement: “Note to existing enrollees: This formulary has

changed since last year. Please review this document to make sure that it

still contains the drugs you take.”

• The definition of a formulary as compared to an abridged formulary (42

CFR 423.4 defines “formulary” as “the entire list of Part D drugs covered

by a Part D plan”)

• An explanation of how to use the Part D Sponsor’s formulary document

• The following statement: “<Part D Plan Sponsor Name> covers both

brand name drugs and generic drugs. A generic drug is approved by the

FDA as having the same active ingredient as the brand name drug.

Generally, generic drugs cost less than brand name drugs.”

• A statement describing the Part D Sponsor’s general utilization

management procedures

• The date the formulary was last updated and describe how to obtain

updated formulary information

• A statement that if a drug is not on the formulary, enrollees may contact

the Part D Sponsor to obtain a list of alternatives or to apply for

exceptions to coverage rules

• An explanation of how to obtain an exception to the Part D Sponsor’s

formulary, utilization management tools or tiered cost sharing

• A description of the Part D Sponsor’s drug transition policy

• A statement that enrollees may contact the Part D Sponsor for additional

information or questions on the formulary

• A chart (the CMS-approved formulary) of covered drugs organized by

therapeutic category that includes at least two covered drugs for each

therapeutic class. Exceptions to this include when only one drug exists in

the category or class or in the case where two drugs exist in the category

or class, and one is clinically superior to the other. The category or class

names must be the same as those found on the CMS-approved Part D

Sponsor formulary.

Note: While Part D Sponsors must ensure that at least two drugs per

therapeutic class are included within the abridged formulary, Part D

Sponsors have the option to include the therapeutic classes as

subheadings within the abridged formulary, as this level of detail may

be confusing for enrollees. The row of the chart must include at least

the three items described below.

• Drug Name: We suggest capitalizing brand name drugs (e.g., LIPITOR),

and listing generic drugs in lowercase italics, (e.g., penicillin). Part D

Sponsors may include the generic name of a drug next to the brand name

of the drug. The abridged formulary may only consist of drugs included

on the CMS approved HPMS formulary. Formulary drug enhancements

described in section 60.4 may not be included in the abridged formulary

document.

• Tier Placement: Part D Sponsors that provide different levels of coverage

for drugs depending on their tier should include a column indicating the

drug’s tier placement and the corresponding tier label description (e.g.,

Generic or Preferred Brand) from the approved PBP. Part D Sponsors may

also choose to include a column providing the co-payment or co-

insurance amount for each tier.

• Utilization Management (UM): Part D Sponsors must indicate any

applicable UM tools (e.g., prior authorization, step therapy, and quantity

limit restrictions) for the drug. A description of the indicator used to

describe the UM tools must be provided somewhere within the document

(e.g., in footnotes). For example, a Part D Sponsor may choose to

designate a prior authorization on a drug by placing an asterisk next to

the name of the drug.

Note: Every enrollee must be able to tell by examining the complete

formulary whether a specific drug is covered—including those drugs

that have varying dosage forms or strengths at different formulary

statuses, tier placements, and/or utilization management

procedures (e.g., prior authorization, step therapy, quantity limit,

or other restrictions). If there are differences in formulary status,

tier placement, quantity limit, prior authorization, step therapy, or

other restrictions for a drug based on its differing dosage forms or

strengths, the formulary must clearly identify how it will treat the

different formulations of that same drug.

- An index listing drugs in alphabetical order that directs the

reader to the page containing complete information for that

drug, (e.g., name, tier placement, and utilization

management strategy)

- A symbol or abbreviation, as well as an explanation, to

identify any utilization management restrictions, drugs that

are available via mail-order, excluded drugs, free first fill

drugs, limited access drugs, drugs covered in the coverage

gap, and drugs covered under the medical benefit (for home

infusion drugs only)

- Part D Sponsors may not include OTC drugs in the formulary

table, but are expected to provide a separate list or table

60.4.2 – Comprehensive Formulary

42 CFR 423.4, 423.120, 423.128(c)(1)(v)

The comprehensive formulary must include the same information provided

within the abridged formulary document, except that the comprehensive

formulary must include the entire list of drugs covered by the Part D

Sponsor (for instance, drugs covered as an enhancement) and would not

inform beneficiaries that they can obtain a comprehensive formulary by

contacting the Part D Sponsor. Drugs adjudicated at the point of sale as

formulary drugs that are not found on the CMS approved HPMS formulary

must be included in the comprehensive formulary. This may include drugs

that are not found on the CMS approved HPMS formulary as described in

section 60.4.

60.4.3 – Changes to Printed and Posted Formularies

42 CFR 423.120(b), 423.128(a)-(c)(d)(2)(ii)

Part D Sponsors will be expected to update all impacted abridged and

comprehensive printed formularies with any applicable formulary changes.

Part D Sponsors may make any necessary formulary changes via errata

sheets mailed to affected enrollees. While Part D Sponsors retain the

flexibility to utilize other processes for notifying enrollees of non-

maintenance changes to their printed formularies, CMS expects Part D

Sponsors to send out errata sheets with formulary changes no less than

monthly to the extent that any negative non-maintenance formulary

changes have occurred and that affected enrollees will receive a hard copy of

such changes (website updates alone will not suffice). Consistent with

formulary errata sheets and hard copy notifications, website updates for

applicable negative non-maintenance formulary changes must also be made

no less than monthly. Errata sheets must include a statement explaining

that the plan will continue to cover the drugs in question for enrollees taking

the drug at the time of change for the remainder of the plan year as long as

the drug continues to be medically necessary and prescribed by the

enrollee’s physician and was not removed for safety reasons. Refer to the

Medicare Prescription Drug Benefit Manual, Chapter 6, sections 30.3.3.3 and

30.3.4.1. This requirement does not extend to mid-year maintenance

changes defined in section 30.3.3.2 of the Medicare Prescription Drug

Benefit Manual (http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html). Changes to

previously printed formularies resulting from mid-year maintenance changes

may be made at the time of the next printing. This is not a substitute for the

required advance 60 days’ notice to affected beneficiaries.

60.4.4 – Other Formulary Documents

42 CFR 423.128(b)(4)

In addition to comprehensive and abridged formularies, Part D Sponsors

may choose to develop a formulary that lists all of their preferred drugs or is

tailored to individuals with specific chronic conditions, as long as these items

supplement the two required documents rather than replace them and

include the disclaimer in section 50.16.

60.4.5 – Provision of Notice to Enrollees Regarding Formulary Changes

42 CFR 423.120(b)(5)

Part D Sponsors must provide at least sixty (60) days’ notice or a 60-day

supply with notice to affected enrollees before removing a Part D drug from

the Part D Sponsor’s formulary (e.g., adding prior authorization, quantity

limits, step therapy or other restrictions on a drug), or moving a drug to a

higher cost-sharing tier. A sixty (60) day notice must be provided in writing

unless a beneficiary has affirmatively elected to receive electronic notice.

Part D Sponsors should refer to Chapter 6 of the Medicare Prescription Drug

Benefit Manual, section 30.3.4.1

(http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html).

If a Part D Sponsor does not provide 60 days advance written notice to an

affected enrollee, the Part D Sponsor must provide a 60-day fill of the

prescription under the same terms as previously allowed, with written notice

of the change.

60.4.6 – Provision of Notice to Other Entities Regarding Formulary Changes

42 CFR 423.120(b)(5)

Prior to removing a covered Part D drug from its formulary, or making any

change in the preferred or tiered cost-sharing status of a covered Part D

drug, a Part D Sponsor must provide at least sixty (60) days’ notice to CMS,

State Pharmaceutical Assistance Programs, entities providing other

prescription drug coverage, authorized prescribers, network pharmacies, and

pharmacists prior to the date such change becomes effective. Part D

Sponsors should refer to Medicare Prescription Drug Benefit Manual, Chapter

6, section 30.3.4.2 (http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html).

60.5 – Part D Explanation of Benefits

42 CFR 423.128(e)

Part D Sponsors must ensure that enrollees who utilize their prescription

drug benefits in a given month receive their Explanation of Benefits (EOB)

by the end of the month following the month in which they utilized their

prescription drug benefits.

MMPs that use the Part D EOB model are expected to include all Medicaid-

required excluded drugs/OTCs, which are submitted on the Additional

Demonstration Drug (ADD) file. For more information, please refer to the

Part D EOB Model instructions.

Note: An EOB does not need to be generated by the Part D Sponsor

when retroactive changes apply to prior benefit year prescription fills.

For example, a Part D Sponsor’s final EOB for CY 2015 must be sent in

January 2016, for December 2015 fills. Once the final EOB for CY 2015

has been sent, Part D Sponsors are not required to send an EOB for

any retroactive adjustments for prior benefit year fills (prescription fills

made prior to December 31, 2015).

60.6 – Annual Notice of Change (ANOC) and Evidence of Coverage (EOC)

42 CFR 417.427, 422.111(a)(3), 422.111(d)(2), 423.128 (a)(3)

All Plans/Part D Sponsors, including Section 1876 cost plans that do and do

not offer Part D benefits, must send the ANOC/EOC for enrollee receipt by

September 30 of each year. New enrollees with an effective date of October

1, November 1, or December 1, should receive both an EOC for the current

contract year and an ANOC/EOC for the upcoming contract year. New

enrollees with an effective date of January 1 or later must receive an EOC

for the contract year of coverage. Stand-alone EOCs do not need to be

resubmitted in HPMS.

D-SNPs may choose to send the ANOC for enrollee receipt by September 30,

and the EOC for enrollee receipt by December 31. D-SNPs that choose this

option must also send an SB with the ANOC. D-SNPs that send a combined

ANOC/EOC for enrollee receipt by September 30 are not required to send an

SB to current enrollees.

Employer/union group plans must send the ANOCs and EOCs for enrollee

receipt no later than fifteen (15) days before the beginning of the

employer/union sponsor’s open enrollment period (refer to Chapter 9 of the

Medicare Managed Care Manual and Chapter 12 of the Medicare Prescription

Drug Benefit Manual).

To ensure that Plans/Part D Sponsors are mailing their ANOC/EOC timely,

Plans/Part D Sponsors must indicate the actual mail date and the number of

enrollees that were mailed the documents in HPMS within 15 days of

mailing. This includes mail dates for alternate materials. Plans/Part D

Sponsors that mail in waves should enter the actual mail date for each wave.

Organizations may enter up to ten waves of mailings. For instructions on

meeting this requirement, refer to the Update Material Link/Function section

of the Marketing Review Users Guide in HPMS.

Plans/Part D Sponsors must use the standardized ANOC/EOC errata model to

correct any errors and must submit the errata model for review via HPMS.

Plans/Part D Sponsors must ensure corrected versions of the ANOC and EOC

are on their websites. Plans/Part D Sponsors are not required to post the

ANOC/EOC errata model on websites.

60.7 – Other Mid-Year Changes Requiring Enrollee Notification

42 CFR 422.111(d)(3) and (e), 423.128(g)

CMS requires enrollee notification of mid-year benefit changes at least 30

days prior to the effective date. Examples of changes include National

Coverage Determinations (NCD), legislative changes in benefits, plan rule

changes, or provider network changes. Guidance on significant mid-year

provider network changes can be found in Chapter 4 of the Medicare

Managed Care Manual. If an NCD or legislative change in benefits is

announced or finalized less than 30 days prior to the effective date,

notification is required as soon as possible. Mid-year benefit changes due to

an NCD or legislative change in benefits must be reflected on the Plan/Part D

Sponsor website. See also Chapter 4 of the Medicare Managed Care Manual,

section 90.3 - General Rules for NCDs.

For NCDs or legislative changes in benefits that result in a new mid-year

benefit, Plans/Part D Sponsors must publish the notification in the next plan

newsletter or other mass mailing not specifically dedicated to the NCD

notification. Alternatively, Plans/Part D Sponsors may choose to provide this

information to enrollees via email (if the enrollee has opted to receive

communications via email as described in section 40.9 of the Medicare

Marketing Guidelines) or one-time mailings specific to this issue. NCD

communications do not need to be submitted in HPMS.

Plans/Part D Sponsors should refer to the appropriate guidance for the

requirements of each change. For more information visit:

• NCD

http://www.cms.gov/medicare-coverage-database/overview-and-

quick-search.aspx?list_type=nca

• Medicare Prescription Drug Benefit Manual

http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html.

70 – Promotional Activities, Rewards, Incentives, Events and Outreach

70.1 – Promotional Activities

42 CFR 422.2268, 423.2268

Generally, promotional activities are designed to attract the attention of

prospective enrollees and/or encourage retention of current enrollees. In

addition to the guidance on nominal gifts, any promotional activities or items

offered by Plans/Part D Sponsors must:

• Have only nominal value (be worth no more than $15) based on the

fair market value of the item or less, with a maximum aggregate of

$50 per person, per year;

• Be offered to all people regardless of enrollment and without

discrimination;

• Not be items that are considered a health benefit (e.g., a free

checkup); and

• Not be tied directly or indirectly to the provision of any other covered

item or service.

Note: Plans/Part D Sponsors should track and document items

given to current enrollees. Plans/Part D Sponsors are not

required to track pre-enrollment promotional items on a per

person basis; however, they may not willfully structure pre-

enrollment activities with the intent to give people more than

$50 per year.

70.1.1 – Nominal Gifts

42 CFR 422.2268(a), (b), and (c), 423.2268(a), (b), and (c)

Plans/Part D Sponsors may offer gifts to potential enrollees, as long as those

gifts are of nominal value, provided regardless of enrollment, and without

discrimination.

The following rules must be followed when providing nominal gifts:

• If a nominal gift is one large gift (e.g., a concert, raffle, drawing), the

total fair market value must not exceed the nominal per person value

based on attendance. For example, if 10 people are expected to attend

an event, the nominal gift may not be worth more than $150 ($15 for

each of the 10 anticipated attendees). For planning purposes,

anticipated attendance may be used, but must be based on actual

venue size, response rate, or advertisement circulation.

• Nominal gifts may not be in the form of cash or other monetary

rebates, even if their worth is $15 or less.

Note: Plans/Part D Sponsors should refer to the Office of Inspector

General’s website regarding advisory opinions on gifts and gift cards.

70.2 – Marketing of Rewards and Incentives Programs

42 CFR 422.134(c)(2)(ii), 422.2268

Rewards and incentives programs are for current enrollees only. However,

Plans may include information about rewards and incentives programs in

marketing materials to potential enrollees, as long as those communications:

• Are not used to target potential enrollees;

• Are provided to all potential enrollees without discrimination;

• Are provided in conjunction with information about Plan benefits; and

• Include information about all rewards and incentives programs offered

by the Plan, and are not limited to a specific program, or a specific

reward or incentive within a program.

For information regarding rewards and incentives program requirements,

please see Chapter 4 of the Medicare Managed Care Manual.

Note: Nominal gifts that are part of a promotional activity are different

from rewards and incentives.

70.3 – Exclusion of Meals as a Nominal Gift

42 CFR 422.2268(p), 423.2268(p)

Plans/Part D Sponsors may not provide or subsidize meals at

sales/marketing events. However, Plans/Part D Sponsors may provide

refreshments and light snacks. Plans/Part D Sponsors should use their best

judgment on the appropriateness of food products provided, and should

ensure that items provided could not be reasonably considered a meal

and/or that multiple items are not being “bundled” and provided as if a

meal.

Meals may be provided at educational events, provided the event meets

CMS’ strict definition of an educational event, and complies with the nominal

gift requirement in section 70.1.1.

70.4 - Unsolicited Electronic Communication Policy

42 CFR 422.2268(d), 423.2268(d)

A Plan/Part D Sponsor may not initiate separate electronic contact (e.g.,

email, direct message, text message), unless an individual has agreed to

receive those communications. If an individual comments, likes or follows a

Plan/Part D Sponsor on social media, this does not constitute agreement to

receive Plan/Part D Sponsor communications outside of the public social

media forum. Plans/Part D Sponsors may not initiate separate

communications to specific social media users. Pop-ups or targeted

advertisements that comply with all marketing rules are permitted.

In addition, Plans/Part D Sponsors may respond to a question or statement

initiated by the beneficiary on a public social media forum, but may not

address subjects beyond the scope of the question or statement.

Plans/Part D Sponsors are prohibited from renting or purchasing email

lists to distribute information about MA, PDP, or Section 1876 cost

plans, and may not send electronic communications to individuals at

email addresses or on social media obtained through friends or

referrals.

Plans/Part D Sponsors must provide an opt-out process for enrollees to

no longer receive email or other electronic communications.

70.5 – Marketing through Unsolicited Contacts

42 CFR 422.2268(d), 423.2268(d)

In general, Plans/Part D Sponsors may not market through unsolicited direct

contact, including but not limited to:

• Door-to-door solicitation, including leaving information such as a

leaflet or flyer at a residence or car

• Approaching potential enrollees in common areas (e.g., parking lots,

hallways, lobbies, sidewalks, etc.)

• Telephonic or electronic solicitation, including leaving electronic

voicemail messages or text messaging

Note: Agents/brokers who have a pre-scheduled appointment with

a beneficiary that becomes a “no-show” may leave information at

the no-show potential enrollee’s residence.

The prohibition on marketing through unsolicited contacts does not

extend to conventional mail and other print media (e.g.,

advertisements, direct mail).

In addition, if a potential enrollee provides permission to be called or

otherwise contacted, the contact must be event-specific, and may not

be treated as open-ended permission for future contacts.

70.6 – Telephonic Contact

42 CFR 422.2268(d), (e), and (f), 423.2268(d), (e), and (f)

Agents may contact their own clients and Plans/Part D Sponsors may contact

current enrollees at any time to discuss plan business. Prohibited telephonic

activities include, but are not limited to, the following:

• Bait-and-switch strategies - making unsolicited calls about other

business as a means of generating leads for Medicare plans.

• Calls based on referrals - if an individual would like to refer a friend or

relative to an agent or Plan/Part D Sponsor, the agent or Plan/Part D

Sponsor may provide contact information such as a business card that

the individual may give to a friend or relative. Otherwise, as instructed

in section 30.8, a referred individual needs to contact the plan or

agent/broker directly.

• Calls to former enrollees who have disenrolled, or to current enrollees

who are in the process of voluntarily disenrolling (except as permitted

below), to market plans or products. Enrollees who are voluntarily

disenrolling from a plan should not be contacted for sales purposes or

be asked to consent in any format to further sales contacts.

• Calls to beneficiaries who attended a sales event, unless the

beneficiary gave express permission at the event for a follow-up call

(the Plan/Part D Sponsor must have documentation of permission to

be contacted).

• Calls to beneficiaries to confirm receipt of mailed information, except

as permitted below.

Plans/Part D Sponsors may conduct the following telephonic activities:

• Call beneficiaries who submit enrollment applications to conduct

quality control and/or agent/broker oversight activities.

• Call their current MA and non-MA enrollees or use third-parties to

contact their current MA and non-MA enrollees about MA/Part D plans.

Examples of allowed contacts include, but are not limited to, calls to

enrollees aging-in to Medicare from commercial products offered by

the same organization and calls to an organization’s existing

Medicaid/MMP plan enrollees to talk about its Medicare products. When

discussing Medicaid products, Plans/Part D Sponsors must follow all

applicable Medicaid marketing rules.

• Call their current MA enrollees to promote other Medicare plan types or

to discuss plan benefits (e.g., sponsors may contact their PDP

enrollees to promote their MA-PD offerings; Plans/Part D Sponsors that

are also Medigap issuers may market their MA, PDP, or cost plan

products to their Medigap enrollees).

• Call their current enrollees, including via automated telephone

notification, to discuss/inform them about general plan information

such as Annual Enrollment Period (AEP) dates, availability of flu shots,

upcoming plan changes, educational events and other important plan

information.

• Call their current enrollees to conduct normal business related to

enrollment in the plan, including calls to enrollees who have been

involuntarily disenrolled to resolve eligibility issues.

• Call former enrollees after the disenrollment effective date to conduct

disenrollment surveys for quality improvement purposes.

Disenrollment surveys may be conducted telephonically or mailed.

Surveys conducted in either manner may not include sales or

marketing information.

• Under limited circumstances and subject to advance approval from the

appropriate CMS Account Manager, call LIS-eligible enrollees that a

plan is prospectively losing due to reassignment to encourage them to

remain enrolled in their current plan.

• Call individuals who have expressly given permission for a plan or

sales agent to contact them, for example, by filling out a business

reply card (BRC) or asking a customer service representative (CSR) to

have an agent contact them. This permission applies only to the entity

from which the individual requested contact, for the duration of that

transaction, for the scope of product, (e.g., MA-PD plan or PDP),

previously discussed or indicated in the reply card.

• Return phone calls or messages from individuals or enrollees, as these

are not considered unsolicited contacts.

70.7 – Enrollment and Verification Requirements

42 CFR 422.2272(b), 423.2272(b)

Plans/Part D Sponsors are required to maintain a system to ensure

beneficiaries are enrolled into the plan they requested and understand

the rules applicable to that plan. This system must be maintained for all

agent/broker assisted enrollments, including enrollment requests in

which an independent or employed agent/broker provided plan-specific

information to the individual, thus potentially influencing the individual’s

plan choice and/or assisting in a subsequent enrollment request.

Plans/Part D Sponsors have the option to complete the enrollment

verification process by telephone, email (if beneficiary opted-in for email) or

direct mail. The beneficiary must be contacted within fifteen (15) calendar

days of receipt of the enrollment request. Plans/Part D Sponsors may

integrate the enrollment verification process into an existing practice, such

as Welcome Calls, without making a separate call for enrollment verification.

If the Plan/Part D Sponsor chooses to utilize a telephonic contact but is

unable to speak with the individual or his or her appointed/authorized

representative directly, the Plan/Part D Sponsor must either continue call

attempts or follow up with a written communication.

The timing and method of contact must be documented and the following

information should be provided:

• Introduction and Plan/Part D Sponsor name;

• Reason for call, email or letter;

• Confirmation of receipt of application into plan (specific plan name);

• Request additional information if needed to complete the enrollment

request;

• Explanation as to how the plan works (e.g., HMO, PFFS, Section 1876

cost plan);

• Inform beneficiary that additional enrollment material is forthcoming,

including ID card;

• Provide at least two cost sharing/coinsurance examples, such as PCP

and specialists visits;

• Explain the monthly premium (LIS and non-LIS);

• Explain physician/pharmacy network may change and that they can

find an up-to-date list on the Plan’s/Part D Sponsor’s website;

• Explain that beneficiary may cancel enrollment within seven (7)

calendar days from the date of the email, letter or phone call or by the

last calendar day of the month prior to the enrollment effective date,

whichever is later. For AEP enrollment requests, the cancellation date

is December 31. (For more details on the election periods that apply in

this situation, see Chapter 2 and Chapter 3 section 30

http://www.cms.gov/Medicare/Eligibility-and-

Enrollment/MedicareMangCareEligEnrol/);

• Offer to address basic questions regarding cost-sharing for PCP and

specialists office visits; and

• For beneficiaries enrolled in Part D: explain pharmacy access and drug

formulary.

The following agent/broker-assisted enrollments are excluded from the

enrollment verification process:

• Enrollments into employer or union sponsored plans

• Enrollments from one plan to another plan within a parent organization

involving the same plan type or product type (e.g., PFFS to PFFS, D-

SNP to D-SNP, PDP to PDP)

Plans/Part D Sponsors should not delay the processing of the enrollment

request (including, but not limited to, activation of benefits and submission

of enrollment request data to CMS) while completing the enrollment

verification process. If the enrollment request is incomplete upon initial

receipt, Plans/Part D Sponsors are expected to conduct the enrollment

verification process while attempting to obtain the information needed to

complete the enrollment request.

Enrollment verification contacts should be made to the applicant only after

the enrollment request is received. The Plan/Part D Sponsor is expected to

ensure that enrollment verifications are not conducted by sales agents. Also,

if calling or emailing applicants, Plans/Part D Sponsors are expected to

ensure that sales agents are not physically present with the applicant at the

time of the verification. CMS expects enrollment verification calls to be

interactive. Plans/Part D Sponsors may not use automated calling

technologies to conduct enrollment verifications via telephone.

If the Plan/Part D Sponsor makes a determination to deny an enrollment

request prior to completing the enrollment verification process, it is expected

to discontinue the process and instead inform the individual of his or her

ineligibility. If the Plan/Part D Sponsor receives a transaction reply report

(TRR) from CMS rejecting the enrollment prior to completing the enrollment

verification process, it is expected to suspend the process, but must resume

if the Plan/Part D Sponsor determines the rejection to be erroneous, such

that the enrollment will be resubmitted to CMS.

70.8 – Prospective Enrollee Educational Events

42 CFR 422.2268(l), 423.2268(l)

An educational event is an event designed to inform Medicare beneficiaries

about Medicare Advantage, Prescription Drug or other Medicare programs

and does not include marketing (i.e., the event sponsor does not steer, or

attempt to steer, potential enrollees toward a specific plan or limited number

of plans). Educational events may be hosted in a public venue by the

Plan/Part D Sponsor or an outside entity. These events cannot be held at in-

home or one-on-one settings.

Educational events for prospective enrollees may not include any sales

activities including the distribution of marketing materials or the

distribution/collection of plan applications. This includes the distribution of

any material with plan-specific information (including plan-specific

premiums, co-payments, or contact information). Educational events must

be explicitly advertised as “educational,” otherwise they will be considered

as sales/marketing events.

The intent of this guidance is not to preclude Plans/Part D Sponsors from

informing beneficiaries about their products; rather, it is to ensure that

events that are advertised as “educational” are only educational and comply

with CMS’ requirements. More specifically, Plans/Part D Sponsors may

provide education at a sales or marketing event, but may not market or sell

at an educational event.

The following are examples of acceptable materials and activities by

Plans/Part D Sponsors or their representatives at an educational event:

• A banner with the plan name and/or logo displayed

• Promotional items, including those with plan name, logo, and toll-free

customer service number and/or website. Promotional items must be

free of benefit information and consistent with CMS’ definition of

nominal gift

• Responding to questions asked at an educational event

At educational events, Plans/Part D Sponsors or their representatives are

prohibited from the following:

• Discussing plan-specific premiums and/or benefits;

• Distributing plan-specific materials;

• Distributing or displaying business reply cards, scope of appointment

forms, enrollment forms, or sign-up sheets;

• Setting up individual sales appointments or getting permission for an

outbound call to the beneficiary;

• Attaching business cards or plan/agent contact information to

educational materials, unless requested by the beneficiary; and

• Advertising an educational event and then have a marketing/sales

event immediately following in the same general location (e.g., same

hotel).

70.8.1 – Enrollee-Only Educational Events

§ 1851(j)(1)(D), 42 CFR 422.2268(l), 423.2268(l)

Plans/Part D Sponsors that hold enrollee-only educational events may

not conduct enrollment or sales activities, as described in section 70.8,

during these events. Plans/Part D Sponsors may discuss plan-specific

premiums and/or benefits and distribute plan-specific materials to

enrollees. In this context only (i.e., events for existing enrollees only),

this discussion of benefits is not considered a sales activity.

Educational events must be explicitly advertised as “educational;”

otherwise, they will be considered by CMS as sales/marketing events.

Any marketing of these events must be done in a way that reasonably

targets only existing enrollees (e.g., direct mail flyers), not the mass

marketplace (e.g., radio or newspaper ad).

70.9 – Marketing/Sales Events and Appointments

42 CFR 422.2268, 423.2268

Marketing/sales events and appointments are designed to steer, or attempt

to steer, potential enrollees toward a plan or limited set of plans. At

marketing/sales events and appointments, plan representatives may discuss

plan specific information and collect applications.

There are two main types of marketing/sales events: formal and informal.

Formal marketing/sales events are typically structured in an

audience/presenter style with a sales person or plan representative formally

providing specific Plan/Part D Sponsor information via a presentation on the

products being offered.

Informal marketing/sales events are conducted with a less structured

presentation or in a less formal environment. They typically utilize a table or

recreational vehicle (RV) with a sales person or Plan/Part D Sponsor

representative who can discuss the merits of the plan’s products.

Plans/Part D Sponsors must submit all sales scripts and presentations for

approval to CMS prior to their use during the marketing/sales event and/or

appointment.

At marketing/sales events and appointments, Plans/Part D Sponsors may

not:

• Conduct health screening or other like activities that could give the

impression of “cherry picking.”

• Require beneficiaries to provide any contact information as a

prerequisite for attending the event. This includes requiring an email

address or any other contact information as a condition to RSVP for an

event online or through mail. Plans/Part D Sponsors should clearly

indicate on any sign-in sheets that completion of any contact

information is optional.

• Use personal contact information obtained to notify individuals of raffle

or drawing winnings for any other purpose.

70.9.1 – Notifying CMS of Scheduled Marketing Events

42 CFR 422.2268, 423.2268, 422.504(f)(2), 423.505(f)(2)

Plans/Part D Sponsors must notify CMS of all formal and informal

marketing/sales events via HPMS prior to advertising the event or seven (7)

calendar days prior to the event’s scheduled date, whichever is earlier.

Changes to marketing/sales events (e.g., cancellations and room changes)

should be updated in HPMS at least forty-eight (48) hours prior to the

scheduled event.

If a sales event is canceled before its originally scheduled date and time, the

Plan/Part D Sponsor must cancel the event in HPMS, more than forty-eight

(48) hours prior to the originally scheduled date and time of the event,

whenever possible.

70.9.2 – Personal/Individual Marketing Appointments

42 CFR 422.2268(f)-(h), 423.2268(f)-(h)

All Plans/Part D Sponsors conducting one-on-one appointments with

beneficiaries, regardless of the venue (e.g., in home, telephonic, or library),

must follow the scope of appointment guidance (see section 70.9.3).

Note: One-on-one appointments are not entered in the HPMS

marketing events module.

The Plan’s/Part D Sponsor’s representative may not do the following:

• Discuss plan options that were NOT agreed to by the beneficiary

• Market non-health care related products (such as annuities or life

insurance)

• Ask a beneficiary for referrals

• Solicit/accept an enrollment request (application) for a January 1

effective date prior to the start of the Annual Enrollment Period (AEP)

unless the beneficiary is entitled to another enrollment period

70.9.3 – Scope of Appointment

42 CFR 422.2262, 422.2268(g) and (h), 423.2262, 423.2268 (g) and (h)

When conducting marketing activities, in-person or telephonically, a

Plan/Part D Sponsor may not market any health care related product during

a marketing appointment beyond the scope that the beneficiary agreed

before the meeting with that individual. The Plan/Part D Sponsor must

document the scope of the agreement 48 hours prior to the appointment,

when practicable. Distinct lines of plan business include MA, PDP and Cost

Plan products. If a Plan/Part D Sponsor would like to discuss additional

products during the appointment in which the beneficiary indicated interest,

but did not agree to discuss in advance, the Plan/Part D Sponsor must

document a second scope of appointment (SOA) for the additional product

type to continue the appointment.

SOA documentation is subject to the following requirements:

• The documentation may be in writing, in the form of a signed

agreement by the beneficiary, or a recorded oral agreement. Any

technology (e.g., conference calls, fax machines, designated recording

line, pre-paid envelopes, and email) can be used to document the

scope of appointment.

• Date of appointment

• Beneficiary contact information (e.g., name, address, telephone

number)

• Written or verbal documentation of beneficiary or

appointed/authorized representative agreement

• The product type(s) (e.g., MA, PDP, MMP) the beneficiary has agreed

to discuss during the scheduled appointment

• Agent information (e.g., name and contact information)

• An explanation why the SOA was not documented 48 hours prior to

the appointment, if applicable

• A statement clarifying that:

- beneficiaries are not obligated to enroll in a plan

- current or future Medicare enrollment status will not be impacted

- that the beneficiary is not automatically enrolled in the plan(s)

discussed

A beneficiary may sign an SOA at a marketing/sales event for a future

appointment. Marketing/sales events, as defined in section 70.9, do not

require documentation of beneficiary agreement.

Note: All business reply cards (BRC) used for documenting a

beneficiary’s SOA, agreement to be contacted, confirmation of

attendance to a sales/marketing event, or request for additional

information must be submitted in HPMS. Plans/Part D Sponsors should

include a statement on the BRC informing the beneficiary that a sales

person may call as a result of their returning a BRC. See section 90.2

for information on the material submission process.

70.9.4 – Beneficiary Walk-ins to a Plan or Agent/Broker Office or Similar

Beneficiary-Initiated Face-to-Face Sales Appointment

42 CFR 422.2268(g) and (h), 423.2268 (g) and (h)

In instances where a beneficiary visits a Plan/Part D Sponsor or an

agent/broker office on his/her own accord, the Plan/Part D Sponsor or

agent/broker must document the SOA prior to discussing MA, PDP, or cost

plans.

70.10 – PFFS Plan Provider Education and Outreach Programs

42 CFR 422.114, 422.202

PFFS Plans should conduct effective outreach to providers to help them

understand how PFFS plans work and address concerns about the timeliness

and accuracy of payments. They should ensure that they clearly inform

providers about how to obtain their terms and conditions of payment, how to

get payment or coverage questions answered, and how to appeal payment

decisions.

70.10.1 – PFFS Plan Terms and Conditions of Payment Contact and Website

Fields in HPMS

42 CFR 422.114, 422.202

PFFS plans must provide CMS with their plan terms and conditions of

payment contact and website information via HPMS. All PFFS Plans must

complete the data entry for these fields in HPMS and update the information

as needed in order for CMS to make the determinations required under 42

CFR 422.114.

The “PFFS Terms and Conditions of Payment Contact for Public Website” field

should be populated with the contact that will facilitate provider access to

the MAO’s PFFS plan terms and conditions of payment. Use the following

navigation path in HPMS to enter the appropriate information for this new

contact: HPMS Homepage > Contract Management > Contract Management

> Select a Contract Number > Contact Data.

The “PFFS Terms and Conditions of Payment Website” field should be

populated with the web address for where the Plan maintains its PFFS plan

terms and conditions of payment. Use the following navigation path in HPMS

to enter the appropriate information for this new web address: HPMS

Homepage > Contract Management > Basic Contract Management > Select

a Contract Number > Org. Marketing Data.

70.11 – Marketing in the Health Care Setting

42 CFR 422.2268(e), (j), and (k), 423.2268(e), (j), and (k)

Plans/Part D Sponsors that have agreements with providers in connection

with plan marketing activities should ensure that those agreements address

marketing activity in a manner consistent with Medicare regulations.

Plans/Part D Sponsors should ensure that if a provider advertises non-health

related items or services, such advertisement does not suggest or imply a

relationship with or coverage by the Medicare plan.

Plans/Part D Sponsors may not conduct sales activities in health care

settings except in common areas. Common areas where marketing activities

are allowed include areas such as hospital or nursing home cafeterias,

community, recreational, or conference rooms. If a pharmacy counter area is

located within a retail store, common areas would include the space outside

of where individuals wait for services from or interact with pharmacy

providers and obtain medications.

Plans/Part D Sponsors are prohibited from conducting sales presentations,

distributing and accepting enrollment applications, and soliciting

beneficiaries in areas where individuals primarily receive health care services

or are waiting to receive health care services. These restricted areas

generally include, but are not limited to, waiting rooms, exam rooms,

hospital patient rooms, dialysis center treatment areas (where individuals

interact with their clinical team and receive treatment), and pharmacy

counter areas (where patients interact with pharmacy providers and obtain

medications). The prohibition against conducting marketing activities in

health care settings extends to activities planned in health care settings

outside of normal business hours.

Plans/Part D Sponsors are only permitted to schedule an appointment with a

beneficiary residing in long-term care facilities (including nursing homes,

assisted living facilities, board and care homes, etc.) upon request by the

beneficiary.

Plans/Part D Sponsors may use providers and/or facilities to distribute

and/or make available, Plan/Part D Sponsor marketing materials as long as

the provider and/or the facility distributes or makes available Plan/Part D

Sponsor marketing materials for all plans with which the provider

participates. CMS does not expect providers to proactively contact all

participating plans; rather, a Plan/Part D Sponsor must only ensure that a

provider/facility agrees to make available and/or distribute plan marketing

materials and accept future requests from other Plans/Part D Sponsors with

which the provider/facility participates. Plans/Part D Sponsors may also

provide materials for a provider’s/facility’s common area, such as the waiting

room. Additionally, Plans/Part D Sponsors may provide long-term care

facilities with materials for admission packets announcing all plan contractual

relationships.

SNPs may provide long-term care facility staff, an explanatory brochure for

each I-SNP with which the facility contracts. This material may only be

distributed to residents who meet the I-SNP criteria for enrollment. The

brochure may explain the qualification criteria and the benefits of being

enrolled in an I-SNP. The brochure may have a reply card or telephone

number for the resident or responsible party to call to request a meeting or

additional information.

70.11.1 – Provider-Based Activities

42 CFR 422.2268(e) and (j), 423.2268(e) and (j)

Although providers may not be fully aware of all plan benefits and costs and

may face conflicting incentives when acting as a Plan/Part D Sponsor

representative, Plans/Part D Sponsors may not prohibit contracted providers

from engaging in discussions with beneficiaries should a beneficiary seek

advice. To ensure that providers do not appear to be a Plan/Part D Sponsor

agent, Plans/Part D Sponsors must ensure through their agreements with

providers, that contracted providers are advised of the need to remain

neutral when assisting with enrollment decisions. Plans/Part D Sponsors

should ensure that a provider assists a beneficiary in an objective

assessment of his/her needs and potential options to meet those needs.

Plans/Part D Sponsors should ensure that any assistance provided to a

beneficiary by a contractual, co-branded, or otherwise affiliated provider,

results in a plan selection that is always in the best interest of the

beneficiary.

Plans/Part D Sponsors may not allow contracted providers to:

• Offer scope of appointment forms

• Accept Medicare enrollment applications

• Make phone calls or direct, urge or attempt to persuade beneficiaries

to enroll in a specific plan based on financial or any other interests of

the provider

• Mail marketing materials on behalf of Plans/Part D Sponsors

• Offer anything of value to induce enrollees to select them as their

provider

• Offer inducements to persuade beneficiaries to enroll in a particular

plan or organization

• Conduct health screening as a marketing activity

• Accept compensation directly or indirectly from the plan for enrollment

activities

• Distribute materials/applications in an exam room

Plans/Part D Sponsors may allow contracted providers to:

• Provide the names of Plans/Part D Sponsors with which they contract

and/or participate (see section 70.11.2 for additional information on

provider affiliation)

• Provide information and assistance in applying for the LIS

• Make available and/or distribute plan marketing materials in common

areas

• Refer their patients to other sources of information, such as SHIPs,

plan marketing representatives, their State Medicaid Office, local

Social Security Office, CMS’ website at http://www.medicare.gov/ or

1-800-MEDICARE

• Share information with patients from CMS’ website, including the

“Medicare and You” Handbook or “Medicare Options Compare” (from

http://www.medicare.gov), or other documents that were written by

or previously approved by CMS

70.11.2 – Provider Affiliation Announcements

42 CFR 422.2262(a), 422.2268, 423.2262(a), 423.2268

Plans/Part D Sponsors may allow contracted providers to announce new or

continuing affiliations with specific Plans/Part D Sponsors.

Continuing affiliation announcements may be made through direct mail,

email, phone or advertisement. The announcement must clearly state that

the provider may also contract with other Plans/Part D Sponsors.

New provider affiliation announcements may be made once within the first

30 days of a new contract agreement. In the announcement, Plans/Part D

Sponsors may allow contracted providers to name only one (1) Plan/Part D

Sponsor. This may be done through direct mail, email, or by telephone.

Neither the Plan/Part D Sponsor nor the contracted provider is required to

notify beneficiaries that the provider may contract with other Plans/Part D

Sponsors in new affiliation announcements.

Any provider affiliation announcement materials that describe plan benefits,

premiums, or cost sharing, must be submitted through HPMS. Materials that

only announce the affiliation do not need to be submitted through HPMS.

70.11.3 – SNP Provider Affiliation Information

42 CFR 422.2268, 423.2268

Plans/Part D Sponsors may allow contracted providers to feature SNPs in a

mailing announcing an ongoing affiliation. This mailing may highlight the

provider’s affiliation or arrangement by placing the SNP affiliations at the

beginning of the announcement and may include specific information about

the SNP and must include the appropriate disclaimer (refer to section 50).

This includes providing information on special plan features, the population

served, or specific benefits. The announcement must list all other SNPs with

which the provider is affiliated.

70.11.4 – Comparative and Descriptive Plan Information

42 CFR 422.2268, 423.2268

Plans/Part D Sponsors may allow contracted providers to distribute printed

information provided by a Plan/Part D Sponsor to their patients comparing

the benefits of all of the plans with which the provider contracts. Materials

must include the appropriate disclaimer (refer to section 50). Materials may

not “rank order” or highlight specific plans and should include only objective

information. The Plans/Part D Sponsors must determine a lead Plan to

coordinate submission of these materials in HPMS for review (see section

90.2 for more information on submission of marketing materials).

70.11.5 – Comparative and Descriptive Plan Information Provided by a Non-

Benefit/Non-Health Service Providing Third-Party

42 CFR 422.2268, 423.2268

Plans/Part D Sponsors may allow contracted providers to distribute printed

information comparing the benefits of different Plans/Part D Sponsors (all or

a subset) in a service area when the comparison is done by an objective

third party (e.g., SHIPs, State agency or independent research organizations

that conduct studies). For more information on non-benefit/non-health

service providing third party providers, refer to section 40.8.3.

80 – Telephonic Activities and Scripts

80.1 – Customer Service Call Center Requirements

42 CFR 422.111(h)(1), 423.128(d)(1)

Plans/Part D Sponsors must operate a toll-free call center during usual

business hours for both current and prospective enrollees, seven (7) days a

week, from at least 8:00 a.m. to 8:00 p.m. (according to the time zones for

the regions in which they operate). Current and prospective enrollees must

be able to speak with a live customer service representative. Plans/Part D

Sponsors may use alternative technologies on Thanksgiving and Christmas

Day. For example, a Plan/Part D Sponsor may use an interactive voice

response system or similar technologies to provide the required information

listed below, and/or allow a beneficiary to leave a message in a voice

mailbox. A customer service representative must then return the call in a

timely manner, no more than one (1) business day later.

Note: From February 15 to September 30, Plans/Part D Sponsors may

use alternative technologies on Saturdays, Sundays, and Federal

holidays.

The use of a call center and the provision of information through a call

center is a mandatory requirement for all Plans/Part D Sponsors; CMS will

consider call centers compliant if they meet the following operating

standards:

• Provide information in response to inquiries outlined in sections 80.2-

80.4.

Note: If callers are transferred to a third party for provision of

the information listed in sections 80.2 and 80.4, all other

requirements in section 80.1 apply to the services as performed

by the third party.

• Follow an explicitly defined process for handling customer complaints.

• Provide interpreter service to all non-English speaking and LEP

beneficiaries.

• Inform callers that interpreter services are “free.” Interpreters should

be available within seven (7) minutes of reaching the CSR.

• Provide TTY service to all hearing impaired beneficiaries. CSRs

available through the TTY service should be available within seven (7)

minutes of the time of answer.

• Limit average hold time to two (2) minutes. The average hold time is

defined as the time spent on hold by the caller following the interactive

voice response (IVR) system, touch-tone response system, or recorded

greeting and before reaching a live person.

• Answer 80 percent of incoming calls within 30 seconds.

• Limit the disconnect rate of all incoming calls to five (5) percent. A

disconnected call is defined as a call that is unexpectedly dropped by

the Plan/Part D Sponsor while the caller was navigating the IVR or

connected with a CSR.

Hold time messages (messages played when an enrollee or prospective

enrollee is on hold when calling the plan) that promote the plan or include

benefit information must be submitted in HPMS for review as marketing

materials (see section 90.2 for material submission process). Plans/Part D

Sponsors are prohibited from using hold time messages to sell other

products.

For Pharmacy Technical Help or Coverage Determinations and Appeals Call

Center requirements, refer to Appendix 3.

80.2 – Informational Scripts

42 CFR 422.111(c), 422.2262, 422.2264, 422.2264(e), 423.128(c),

423.2262, 423.2264, 423.2264(e)

Informational scripts may not ask the beneficiary if s/he wants to be

transferred to a sales/enrollment department nor can the Plan’s/Part D

Sponsor’s call center staff automatically transfer the call. In some instances,

a beneficiary may initiate a request for information and subsequently

request enrollment into a plan. Informational calls may lead to

sales/enrollment calls (or transfer to the appropriate sales/enrollment

department). However, such enrollment transfers may only come at the

request of the beneficiary.

Example: A beneficiary calls customer service and requests to hear

information about a particular plan. Based on the information

provided, the beneficiary states that s/he wants to enroll in the plan.

The customer service representative may process the enrollment (if

state law allows CSRs to process enrollments) and/or transfer the call

to the appropriate area for processing because the beneficiary initiated

the request.

Any change in the nature of a call from informational to sales/telephonic

enrollment must clearly inform the beneficiary regarding the change. This

must be done with the full and active concurrence of the beneficiary, ideally

with a yes/no question.

Plans/Part D Sponsors are not required to enter informational scripts into

HPMS. However, they must retain all scripts and make them available upon

request to CMS. Informational scripts must be written in a way that do not

mislead or confuse Medicare beneficiaries or misrepresent the Plan/Part D

Sponsor. At a minimum, Plans/Part D Sponsors must develop scripts that

respond to inquiries from prospective and current enrollees about the

following subjects:

• Best Available Evidence (BAE) policy (applicable to Part D Sponsors)

• Request for pre-enrollment information

• Benefit information

• Cost-sharing information

• Formulary information

• Pharmacy information, including whether a beneficiary’s pharmacy is

in the Part D Sponsor’s network

• Provider information, including whether a beneficiary’s physician is in

the Plan’s network

• Out-of-network coverage

• Claims submission, processing and payment

• Formulary transition process

• Grievance, organization/coverage determination (including exceptions)

and appeals process

• Information on extra help, including how the beneficiary can obtain

extra help

• Current TROOP status (for Part D Sponsors and MA-PDs)

• Information on how to obtain needed forms

• Information on replacing a enrollee identification card

• Service area information

Plans/Part D Sponsors may NOT:

• Include information about other lines of business in scripts

Note: Plans/Part D Sponsors can ask if the caller would like to

receive information about other lines of business offered by the

Plan/Part D Sponsor.

• Request beneficiary identification numbers (e.g., Social Security

number, HICN) except as required to verify membership, determine

enrollment eligibility or process an enrollment request

• Use language in scripts that imply they are recommended or endorsed

by, calling on behalf of or asked to call the enrollee by CMS, Medicare

or DHHS.

• Plans/Part D Sponsors may not transfer outbound calls to inbound

lines for telephone enrollment. Enrollment by telephone is limited to

calls initiated by the beneficiary (i.e., “inbound” calls). If a beneficiary

requests enrollment over the telephone via an outbound call, the agent

can provide information as to how the beneficiary can enroll in the

plan telephonically. Alternatively, the agent may set up a face-to-face

appointment with the beneficiary for application assistance.

80.3 – Enrollment Scripts/Calls

42 CFR 422.60(c), 423.32(b)

Plans/Part D Sponsors must submit enrollment scripts into HPMS. Plans/Part

D Sponsors should incorporate all relevant requirements outlined in these

Guidelines (e.g., hours of operation) into their scripts.

Telephone enrollment scripts must be submitted in their entirety (bullets or

talking points are not acceptable). In developing and submitting enrollment

scripts, Plans/Part D Sponsors must:

• Follow all requirements described in the CMS Eligibility and Enrollment

Guidance in Chapter 2 and Chapter 17, Subchapter D, of the Medicare

Managed Care Manual, as well as Chapter 3 of the Medicare

Prescription Drug Benefit Manual;

• Clearly state the individual is requesting enrollment into [plan name]

and the plan type;

• Provide confirmation of having accepted the telephone enrollment

request, such as a confirmation tracking number or other tracking

mechanism;

• Provide a statement that the individual will receive a notice

acknowledging receipt of the enrollment (e.g., acknowledging request

for additional information or denial of enrollment); and

• Provide contact information for questions including toll-free telephone

and TTY numbers.

Note: Plans may accept enrollment requests via an incoming (in-

bound) telephone call only. Outbound calls are permitted for

enrollment verification purposes (see section 70.7).

80.4 – Telephone Sales Scripts (Inbound or Outbound)

42 CFR 422.2262, 422.2264, 422.2268, 423.2262, 423.2264, 423.2268

Any telephone sales scripts must be submitted to HPMS verbatim (bullets or

talking points are not acceptable). Plans/Part D Sponsors must follow all

guidance in sections 70.4 and 70.5. This guidance also extends to telephone

sales services provided on behalf of the Plan/Part D Sponsor by all

downstream contractors.

In addition, when a beneficiary makes an inbound call directly to a sales

department or agent, the sales department or agent must clearly inform the

beneficiary if/when the nature of the call moves from a sales presentation to

telephonic enrollment. This must be done with the full and active

concurrence of the beneficiary, ideally with a yes/no question.

Outbound sales calls must include a privacy statement clarifying that the

beneficiary is not required to provide any health related information to the

sales agent unless it will be used to determine enrollment eligibility.

90 – The Marketing Review Process

90.1 – Plan/Part D Sponsor Responsibilities

42 CFR 422.2262, 422.2264, 423.2262, 423.2264

Plans/Part D Sponsors must conduct a quality check and ensure that all

marketing materials are consistent with this chapter and all other relevant

CMS issued guidance and instructions prior to submitting materials for

review to CMS. Generally, CMS does not review marketing materials for

typographical or grammatical errors, unless such errors render the materials

inaccurate or misleading.

90.2 – Material Submission Process

42 CFR 422.2262, 423.2262

Plans/Part D Sponsors must submit marketing materials for review through

the Marketing Module of HPMS, which is an automated tool used to enter,

track, and maintain materials submitted to CMS for review and approval.

The HPMS Marketing Module User Guide provides extensive information on

how to use HPMS. Plans/Part D Sponsors should refer to the User Guide for

any questions regarding the Marketing Module or how to submit materials in

HPMS.

If there are any changes or corrections to materials (e.g., the benefit or

cost-sharing information differs from that in the approved bid), the Plan/Part

D Sponsor will be required to correct those materials for prospective

enrollees and send errata sheets/addenda/reprints to current enrollees

within a reasonable timeframe.

Note: Plans/Part D Sponsors must conduct a thorough review of their

Summary of Benefits documents and reprint the document if

inaccuracies are identified.

Under certain circumstances, and with prior approval from CMS, materials

may be submitted outside of HPMS. The review period begins when CMS

receives the materials.

90.2.1 – Submission of Non-English and Alternate Format Materials

42 CFR 422.2262, 422.2264(e), 423.2262, 423.2264(e)

Non-English and alternate format material must either be based on

previously approved or accepted English/standard print versions of the same

material, or include an English translation with the non-English/Alternate

Format material submission. Both non-English and alternate format

materials should be submitted as Alternate Format materials in HPMS. If the

alternate format cannot be submitted to HPMS (e.g., braille), the Plan/Part D

Sponsor should contact its Account Manager about other methods of

submission.

Note: Plans/Part D Sponsors do not need to resubmit large print

materials as an Alternate Format material in HPMS, as long as the only

change to the material is an increased font size and layout changes

due to the increased font size.

There are two exceptions to the above guidance. The first exception is for

the submission of non-English and alternative format materials under a

specified errata code, such as “Errata – Formularies” (code 1020) and

“Errata - Summary of Benefits” (code 1019). When submitting materials

under specified errata codes, the non-English and/or alternative format

materials must be included as a part of the original submission via a zip file.

All materials included in the zip file will have the same material ID.

The second exception is for the submission of non-English and alternative

format required website content referenced in section 100. As outlined in

section 90.2.2, Plans/Part D Sponsors may make the English/standard

website available for public use during the CMS review period. Non-English

and alternative format required website content may be made available prior

to the English/standard website’s approval. The Plan/Part D Sponsor should

first upload the English/standard website, and then enter the

English/standard website’s pending material ID into the “Alternate Formats

Original Material ID” data entry field when submitting any non-English and

alternative format versions. All other requirements outlined in section 90.2.2

apply.

Plans/Part D Sponsors may also submit multi-lingual material that contains

English and another language (or languages). A material will only qualify as

multi-lingual if it always incorporates English and the other language(s).

Plans/Part D Sponsors should include a note in the comments field specifying

that the material is multi-lingual. Multi-lingual material should not be

submitted as an Alternate Format material in HPMS.

Any changes or revisions that are made to the original English version

should be accurately reflected in non-English and alternate format material

and re-submitted as required.

See Appendix 1 for a definition of alternate format materials.

90.2.2 – Submission of Websites for Review

42 CFR 422.2262, 422.2264, 423.2262, 423.2264

Plans/Part D Sponsors must submit in HPMS all required website content

listed in section 100 for review. Plans/Part D Sponsors should submit their

websites via links on a document. CMS reviewers should be able to review

the information as it will be displayed on the website. The link may provide

access to a live website or a test website, provided that the test site displays

information as it will appear to the beneficiary/consumer. Submitting screen

shots or text on a document is not acceptable. If the option to view online is

not feasible, the Plan/Part D Sponsor should contact their Account Manager

prior to submission to receive permission to submit information in a manner

other than a live link.

Once a Plan’s/Part D Sponsor’s website is reviewed and approved in its

entirety, the Plan/Part D Sponsor may update specific pages of the same

website by submitting only the pages to be changed via links on a document

in HPMS. Any updates to pages should be submitted with their own unique

material ID and date stamped accordingly. Plans/Part D Sponsors must

resubmit webpages for review when changes are made to plan benefits,

premiums, or cost-sharing.

Plans/Part D Sponsors may make the website available for public use during

the CMS review period; however, Plans/Part D Sponsors must indicate that

the website is pending CMS review until CMS has either approved or

disapproved the website. If the website or portions of the website are

disapproved, Plans/Part D Sponsors must submit the revision to CMS within

20 days.

Plans/Part D Sponsors are not required to resubmit materials that have

received prior approval for posting on their website. Any documents that

require submission to HPMS should not be posted on the website until they

are approved or accepted by CMS.

See section 100 for required website content.

90.2.3 – Submission of Multi-Plan Materials

42 CFR 422.2262, 423.2262

Multi-Plan Materials are materials that are created by a third-party on behalf

of several Plans/Part D Sponsors. Plans/Part D Sponsors are accountable for

the marketing practices of their third-party organizations and must ensure

that all materials developed on their behalf are and remain compliant with

the most current CMS requirements.

Relevant terms for the multi-plan submission process include:

•

Primary Material

-- The base marketing material that serves as a

model for submission by multiple Plans/Part D Sponsors.

•

Auxiliary Material

-- The secondary marketing materials developed

based on the CMS-approved Primary Material.

•

Coordinating Entity (CE)

-- The third-party entity that develops the

Primary Material for use by the Plans/Part D Sponsors with which it

contracts.

•

Lead Plan/Part D Sponsor (LP)

-- Contracted Plan/Part D Sponsor that

submits the Primary Material for CMS review.

•

Non-Lead Plan/Part D Sponsor

(

NLP

) -- A contracted Plan/Part D

Sponsor that produces and submits the Auxiliary Material to CMS,

based on the approved Primary Material.

When submitting a multi-plan marketing material, the CE that develops the

material must coordinate with the LP to obtain CMS’ approval. The CMS Lead

Region will be the region that has account management oversight and

marketing review of the LP. Upon approval, the LP will inform the CE, who

then provides the NLPs with the primary material’s material ID and

marketing code, so the NLPs may submit their auxiliary materials in HPMS.

Communications pertaining to this process should be documented for

tracking purposes.

The LP must insert the following in the applicable comment fields in HPMS:

• “MULTI-PLAN MARKETING MATERIAL PRIMARY”. This standardized text

must be inserted in the first line of the comments field.

• The name and role of the CE who created the material (e.g., ABC FMO

or XYZ PBM) must be inserted in the second line of the comments

field.

• A list of all MCE or Plan/Part D Sponsor contract numbers for which the

material is applicable.

• Any applicable information related to the piece that will assist CMS

with the review.

The material ID for multi-plan marketing materials is made up of two parts:

the word “MULTI-PLAN;” and any series of alpha numeric characters chosen

at the discretion of the Plan/Part D Sponsor.

The material submission by the LP should be done using the same material

type that would be used if the material was being submitted under the

standard submission process. If the material is disapproved, the CE must

resubmit disapproved pieces through the same LP.

When a NLP receives direction from a CE that a multi-plan “Primary”

material has been approved/accepted, the NLP should submit the “Auxiliary”

material in HPMS using the material type “Multi-Plan Auxiliary Submission”

found under the same category as the LP’s initial submission. For example, a

multi-plan formulary notice created by a PBM would be submitted by the LP

using material type “Other Formulary/Drug Notices (5040).” Once approved,

all NLPs would submit the corresponding auxiliary material under “Mutli-Plan

Auxiliary Submission (5XXX).”

Additionally, NLPs must submit the previously approved/accepted piece

WITHOUT MODIFICATION, except as allowable by CMS. Permissible

modifications are restricted to populating variable elements and adding a

plan name/logo. Materials that have additional modifications are not eligible

for the multi-plan submission process.

When submitting, the NLP must insert the following in the comments field:

• “MULTI-PLAN MARKETING MATERIAL AUXILIARY.” This standardized

text must be inserted in the first line of the comments field.

• The name and role of the CE who created the material.

• A brief description of the material’s previous submission history (e.g.,

This Multi-plan website was previously approved by CMS on

Month/Day/Year. It was initially submitted by ABC123 Health Care

under XXXX material type).

The material ID for auxiliary materials must be identical to the previously

approved/accepted “Primary” material.

NLP multi-plan auxiliary marketing materials will qualify as File & Use

submissions and may not be distributed until the five (5) calendar day

waiting period has passed.

Note: There may be instances where a CE wants to use a material for

a Plan/Part D Sponsor not identified in the original LP submission (e.g.,

if the CE solidifies a contract with a new Plan/Part D Sponsor). To do

so, the NLP should submit the material and provide an explanation in

the comments of HPMS for why it was not listed in the initial listing of

contract numbers (e.g., they were not contracted with the CE during

the initial submission). The Plan/Part D Sponsor should also include

the name, phone, and email contact of the CE.

90.2.4 – Submission of Mobile Applications

42 CFR 422.2262, 423.2262

If a Plan/Part D Sponsor would like to use a mobile application (app) for

marketing to prospective enrollees, the mobile app must be submitted for

approval (see section 100.7). A Plan/Part D Sponsor should submit a

document in HPMS with either:

• A link to access the mobile app online; or

• A statement that the app will be submitted to the Account Manager

outside of HPMS. Include the name(s) of the person(s) at CMS who will

receive the app for review.

If the option to view the mobile app online is not feasible, the Plan/Part D

Sponsor should contact their Account Manager to discuss how they will

provide access to the app. It is not acceptable to submit screen shots or text

on a separate document unless instructed by the AM/Marketing Reviewer.

90.3 – HPMS Material Statuses

42 CFR 422.2262, 423.2262

All marketing materials in HPMS will have an indication of their disposition,

such as a final status of accepted, approved, disapproved, deemed,

withdrawn, alternate format, SA/LIS, or populated template.

Note: If a Plan/Part D Sponsor does not have an executed contract

with CMS, all submitted marketing material will be considered and

marked as conditional.

90.3.1 - Approved

42 CFR 422.2262, 423.2262

Material marked as “approved” indicates that it is approved for use in the

format in which it was submitted and may be distributed by a Plan/Part D

Sponsor. However, CMS may at any time require a Plan/Part D Sponsor to

change previously approved marketing materials, if they are found to be

inaccurate, altered, or otherwise non-compliant.

90.3.2 - Disapproved

42 CFR 422.2262, 423.2262

Material marked as “disapproved” indicates that the material does not

comply with applicable standards, such as regulations, laws, and standards

discussed in the MMG or other relevant guidance. CMS will provide a reason

for the disapproval in HPMS.

90.3.3 - Deemed

42 CFR 422.2262(a)(1), 423.2262(a)(1), 422.2266, 423.2266

If CMS does not approve or disapprove marketing materials within the

specified review time frame, the materials are deemed approved and can be

used by the Plan/Part D Sponsor. The following conditions will apply:

• Materials subject to a 45 day review period will be given the status of

“deemed” on the 46

day.

• Materials subject to a 10 day review period will be given a status of

“deemed” on the 11

day.

• Marketing materials from a Plan/Part D Sponsor without an executed

contract with CMS will receive a conditional deemed approval. After

the contract is awarded, the material disposition will be changed to

“deemed” and can be used by the Plan/Part D Sponsor.

90.3.4 – Withdrawn

42 CFR 422.2262, 423.2262

Plans/Part D Sponsors may request to withdraw a marketing submission

prior to CMS reviewing the material. Plans/Part D Sponsors should submit a

written request to their Account Manager or Marketing Reviewer stating the

reason(s) for the withdrawal.

90.3.5 – Accepted

42 CFR 422.2262, 423.2262

A material status of “accepted” indicates that the material, submitted as File

& Use, is accepted for use in the format in which it was submitted. The

material may be distributed by a Plan/Part D Sponsor five (5) calendar days

after the date of submission. However, CMS may at any time require a

Plan/Part D Sponsor to change previously accepted marketing materials if

found to be inaccurate, altered, or otherwise non-compliant.

90.3.6 – Alternate Format, SA/LIS, and Populated Template

42 CFR 422.2262, 423.2262

When submitted in HPMS, non-English and alternate format materials will

receive a status of “Alternate Format”.

Populated standard templates should be submitted in HPMS under “Final

Expedited Review” codes. These documents will receive a status of

“Populated Template (see section 90.8.2).

The SA/LIS material status applies to special categories of materials. Please

see the HPMS User Guide for an explanation of when this status is applicable

(see section 90.2 for information on the material submission process).

90.4 - Resubmitting Previously Disapproved Pieces

42 CFR 422.2262, 423.2262

Plans/Part D Sponsors should clearly indicate all changes/updates made to a

material, which has been previously disapproved, when it is resubmitted.

This will expedite the review process. Plans/Part D Sponsors should highlight

any text changes and/or insert notes to altered areas on the material.

Plans/Part D Sponsors may develop an alternative process for identifying

changes (e.g., bulleting all changes made within the comments section of

HPMS when submitting the material), provided they receive approval from

the Account Manager.

90.5 - Time Frames for Marketing Review

42 CFR 422.2262(a), 423.2262(a)

Based on the material type, and as indicated by HPMS, marketing materials

submitted in HPMS for prospective review will have a review timeframe of 10

or 45 days. The marketing review time period begins on the date a material

is submitted in HPMS.

90.6 - File & Use Process

42 CFR 422.2262(b), 423.2262(b)

Under the File & Use process, Plans/Part D Sponsors must submit eligible

marketing materials in HPMS at least five (5) calendar days prior to their

distribution and certify that the materials comply with this guidance.

The HPMS Marketing Module identifies those materials that qualify for File &

Use under the material code look-up functionality.

Plans/Part D Sponsors without an executed contract with CMS may submit

File & Use materials. Once the contract is executed, the appropriate officer

of the Plan/Part D Sponsor is essentially attesting to the Plan’s/Part D

Sponsor’s compliance with the File & Use requirements.

90.6.1 - Restriction on the Manual Review of File & Use Eligible Materials

42 CFR 422.2262(b), 423.2262(b)

Plans/Part D Sponsors using File & Use must submit at least ninety (90)

percent of their marketing materials that qualify for File & Use under this

process; meaning that they cannot request a manual review of more than

ten (10) percent of materials that qualify for File & Use (including, but not

limited to model materials that qualify for File & Use submission).

90.6.2 – Loss of File & Use Certification Privileges

42 CFR 422.2262(b), 423.2262(b)

Plans/Part D Sponsors may lose File & Use Certification status or face

compliance action if they:

• Submit or use materials that do not meet the requirements of this

guidance; or

• Fail to file material(s) at least five (5) calendar days prior to their

distribution.

If CMS revokes a Plan’s/Part D Sponsor’s File & Use Certification privileges,

the Plan/Part D Sponsor may be reinstated after the Account Manager

and/or Marketing Reviewer has determined through manual review that the

compliance concerns have been resolved.

90.6.3 – File & Use Retrospective Monitoring Reviews

42 CFR 422.2262(b), 422.2264, 423.2262(b), 423.2264

CMS will periodically conduct retrospective reviews of materials that were

submitted under File & Use to ensure compliance by those Plans/Part D

Sponsors that utilize this process.

90.7 – Model Marketing Materials and Language

42 CFR 422.2262(c), 423.2262(c)

CMS defines two different types of model marketing materials –

standardized and non-standardized. These material types affect the

Plan’s/Part D Sponsor’s timing of use and ability to make changes to the

documents. When a Plan/Part D Sponsor uses a CMS provided model without

modification (verbatim), it results in a 10 day marketing review period or it

may be submitted via File & Use. To facilitate review, Plans/Part D Sponsors

must indicate the model/exhibit title and applicable CMS chapter/manual or

HPMS memorandum date within the comments section of HPMS.

90.7.1 – Standardized Model Materials

42 CFR 422.2262(c), 423.2262(c)

Standardized model materials are marketing materials created and provided

by CMS that, other than the limited exceptions provided below, a Plan/Part D

Sponsor must use without changing the content, format, or order. CMS

allows Plans/Part D Sponsors to make the following changes to all

standardized materials:

• Populating variable fields;

• Correcting grammatical errors;

• Adding customer service phone numbers;

• Adding plan name/logo;

• Adding required disclaimers; and

• Adding the CMS marketing material identification number.

Note: Plans/Part D Sponsors should reference section 30.9 for

acceptable changes to the Star Ratings information document.

90.7.2 – Non-Standardized Model Materials

42 CFR 422.2262(c), 423.2262(c)

Unlike standardized model materials, the use of non-standardized model

materials is at the discretion of the Plan/Part D Sponsor. Plans/Part D

Sponsors that choose to modify the model language must ensure that all

content contained in the model is included in the non-model document. In

addition, any change made to a non-standardized model material, except as

noted below, will result in that material being subject to a 45-day review

period. To facilitate review, Plans/Part D Sponsors should clearly indicate

these changes in the material when it is submitted. Plans/Part D Sponsors

should follow the process in section 90.4 to identify changes.

The following allowable alterations to CMS non-standardized model materials

will still render the material eligible for the 10-day review period or

submission via File & Use:

• Populating variable fields;

• Adding fields for a name, address, date, or enrollee ID;

• Correcting grammatical errors;

• Changing the font;

• Adding any applicable disclaimers;

• Adding the customer service phone number and/or hours of operation;

• Adding the plan name/logo; and

• Adding the CMS marketing material identification number.

Unless otherwise required, Plans/Part D Sponsors may choose to retain the

title of the model document or modify the title to make it more beneficiary

friendly. Any reference to the words “exhibit,” “model,” or “appendix”

contained within the title of the model document must be removed. Any

other modification made to the document will make the material subject to

the standard 45-day review process and/or ineligible for File & Use

submission.

Note: D-SNPs may remove references to LIS from model materials.

90.7.3 – Standardized Language

42 CFR 422.2262(c), 423.2262(c)

Standardized language refers to language developed by CMS, which is

mandatory for use by Plans/Part D Sponsors and cannot be modified in any

way.

90.8 - Template Materials

42 CFR 422.2262, 423.2262

“Template materials” are materials that include placeholders for variable

data to be populated at a later time by the Plan/Part D Sponsor. CMS

classifies template materials as either static templates or standard

templates.

When submitting unpopulated templates, Plans/Part D Sponsors must show

how the placeholders in will be populated by inserting the name of the field

or listing all variables (e.g., “<date>”, “<$10.00 Copay/$15.00 Copay>”).

Changes to non-variable text in a template must be submitted in HPMS (see

section 90.2 for material submission process). If there are changes or

corrections to final materials (e.g., the benefit or cost-sharing information

differs from that in the approved bid), the Plan/Part D Sponsor must make

corrections for prospective enrollees and send errata

sheets/addenda/reprints to current enrollees within a reasonable timeframe.

Note: Identical materials submitted separately and not noted as

template materials are subject to separate review.

90.8.1 - Static Templates

42 CFR 422.2262, 423.2262

Template material is considered “static” when it includes placeholders for the

following variable data fields ONLY:

• Dates;

• Events;

• Addresses, phone or fax numbers;

• Hours of operation;

• Organization or company names;

• Plan/Part D Sponsor name;

• Logos;

• Agent/Agency;

• Federal contracting statement/disclaimer;

• Persons’ names and pronoun variations;

• URLs;

• Enrollee specific variables, (e.g., case numbers, drug specific

references);

• Co-branding information;

• Photos;

• Email and web addresses;

• LIS Rider;

• OEV Scripts and Letters; and

• Page number references.

Plans/Part D Sponsors are not required to submit populated static templates

in HPMS.

To be considered a static template, ALL variable data fields within the

material must be among those listed above. Since populated static

templates are not resubmitted, Plans/Part D Sponsors are not required to

indicate that the unpopulated submission is a template when submitting the

material in HPMS.

90.8.2 - Standard Templates

42 CFR 422.2262, 423.2262

Marketing materials that include placeholders for variable data not listed in

section 90.8.1, such as plan specific benefits, premiums, and cost sharing,

are considered “standard” templates. Plans/Part D Sponsors must submit

final, populated versions of standard templates in the HPMS Marketing

Module using the associated “Final Expedited Review” code within 30 days of

use. If the template does not have a “Final Expedited Review” code,

Plans/Part D Sponsors may not submit the document as a standard

template. The document must instead be submitted with all fields

populated, other than those listed in section 90.8.1. Refer to the HPMS

Users’ Guide for technical template submission instructions.

90.8.3 - Template Materials Quality Review and Reporting of Errors

42 CFR 422.2262, 422.2264, 423.2262, 423.2264

CMS may conduct retrospective reviews, quality checks, or audits of

populated templates. When errors are discovered, Plans/Part D Sponsors

may be required to remedy the error by providing enrollees with updated

information via errata sheets or addenda.

Similarly, when errors are discovered by Plans/Part D Sponsors, the

Plans/Part D Sponsors must report the errors to their Account Manager. In

addition, Plans/Part D Sponsors may be required to remedy the error by

providing enrollees with updated information via errata sheets or addenda.

Note: Any materials, such as errata sheet or addenda, must be

reviewed and approved by CMS prior to their use.

90.9 - Review of Materials in the Marketplace

42 CFR 422.504(f)(2), 422.2268, 423.2268, 423.505(f)

CMS periodically conducts reviews of Plan/Part D Sponsor materials. Reviews

may include, but are not limited to, the following activities:

• Review of on-site marketing facilities, products, and activities during

regularly scheduled contract compliance monitoring visits; and

• Random review of actual marketing pieces as they are used.

100 – Plan/Part D Sponsor Websites and Social/Electronic Media

42 CFR 422.111(h), 422.2264, 422.2268, 423.128(d), 423.2264, 423.2268

All Plan/Part D Sponsor websites must be clear and easy to navigate. Any

marketing materials that include a web address for the Plan’s/Part D

Sponsor’s website are expected to link directly to the organization’s

Medicare-specific pages.

Plans/Part D Sponsors may not provide links to foreign drug sales. This

includes links from advertisements that appear on the Plan’s/Part D

Sponsor’s website.

Plans/Part D Sponsors should note that there may be additional non-

marketing website requirements found in the Medicare Managed Care

Manual, the Medicare Prescription Drug Benefit Manual, and HPMS

memorandums or emails. Updates to marketing website requirements may

also be released through HPMS memoranda or emails.

100.1 – General Website Requirements

Plans/Part D Sponsors must:

• Maintain their current contract year website for current beneficiaries

through December 31 of each year.

• Notify individuals that s/he will leave the Plan’s/Part D Sponsor’s

Medicare information website, if there is a link that will take an

individual to non-Medicare information or to a different website.

• Ensure all websites that market the Plan’s/Part D Sponsor’s products

are in compliance with the applicable requirements.

• Include applicable disclaimers on each webpage.

Plan/Part D Sponsor websites must not:

• Include content that discusses plan-specific benefits, premiums, cost-

sharing, or Star Ratings for products offered in the next contract year

prior to October 1, except as noted in section 100.2.2.

• Require any information be entered by an individual, other than a zip

code, county, and/or state for access to non-beneficiary specific

website content.

• Include notification that Plan/Part D Sponsor is not responsible for the

content of their social media pages or the websites of any downstream

entity that provides information on the Plan/Part D Sponsor’s behalf.

All Plans/Part D Sponsors are expected to:

• Maintain a separate and distinct section on their website for their

Medicare information, if the Plan/Part D Sponsor markets other lines of

business.

• Review and update website content at least monthly. See section

90.2.2 for instructions about when these updates require resubmission

of webpages for approval.

• Note that the status of the website is “pending” until CMS has granted

an approval/disapproval (see section 90.2.2). If a portion of the

Plan’s/Part D Sponsor’s website is disapproved, the disapproved

portion must be removed from the website immediately.

• Include a date stamp on each webpage with the date the page was

last updated.

• Clearly label any links.

100.2 – Required Content

42 CFR 422.111(b) and (h)(2), 42 CFR 423.128(b) and (d)(2)

All Plans/Part D Sponsors must include the following information on their

website:

• The toll-free customer service number and hours of operation, TTY

number, and either a physical or Post Office Box address;

• Information on beneficiaries’ and Plans’/Part D Sponsors’ rights and

responsibilities upon disenrollment;

• The Plan/Part D Sponsor service area;

• A list of premiums and cost-sharing (e.g., co-payments, co-insurance

and deductibles), including any conditions and limitations;

• All out-of-network coverage rules;

• Instructions on how to appoint a representative and a link to the

downloadable version of the CMS Appointment of Representative Form

(CMS Form-1696); and

• A description of and information on how to file a grievance, an

organizational/coverage determination, and an appeal. This must

include:

- Procedures for filing an organizational/coverage determination, a

grievance, and an appeal;

- A direct link to the Medicare.gov complaint website at:

https://www.medicare.gov/MedicareComplaintForm/home.aspx,

where a enrollee can enter a complaint in lieu of calling 1-800-

Medicare;

- Phone number(s) for receiving oral requests;

- Mailing address for written requests;

- Fax number for written requests;

- Links, if applicable, to any forms created by the Plan/Part D

Sponsor for appeals and grievances;

- Information on how to obtain an aggregate number of

grievances, appeals, and exceptions filed with the Plan/Part D

Sponsor; and

- Contact numbers for enrollees and/or physicians to use for

process or status questions.

PFFS Plan websites must also include a link to Plan’s/Part D Sponsor’s Terms

and Conditions of Payment.

MSA Plan websites must also include the following statements:

• “You must file Form 1040, US Individual Income Tax Return, along

with Form 8853, “Archer MSA and Long-Term Care Insurance

Contracts” with the Internal Revenue Service (IRS) for any

distributions made from your Medicare MSA account to ensure you

aren’t taxed on your MSA account withdrawals. You must file these tax

forms for any year in which an MSA account withdrawal is made, even

if you have no taxable income or other reason for filing a Form 1040.

MSA account withdrawals for qualified medical expenses are tax free,

while account withdrawals for non-medical expenses are subject to

both income tax and a fifty (50) percent tax penalty.”

• “Tax publications are available on the IRS website at

http://www.irs.gov or from 1-800-TAX-FORM (1-800-829-3676).”

100.2.1 – Part D Sponsor Required Content

42 CFR 423.128(b) and (d)

In addition to the requirements in section 100.2, Part D Sponsor’s websites

must include:

• Immediate access to the coverage determination and redetermination

processes through a secure location prominently displayed on the

website; and

• Quality assurance policies and procedures, including Medication

Therapy Management (MTM) information, and drug and/or utilization

management information.

Part D Sponsors are also expected to include a separate section or page

about MTM programs, written in plain language appropriate for enrollees,

including:

• Part D Sponsors’ specific eligibility requirements;

• A statement informing enrollees about who to contact at the Part D

Sponsor for more information, with customer service personnel

prepared to answer questions about the MTM program;

• A high level summary of services offered as part of the MTM

program;

• A statement explaining the purpose and benefits of MTM, and that

this is a free service for eligible enrollees;

• A description of how the enrollee will be notified by the Part D

Sponsor that they are eligible and enrolled in the MTM program;

• Statements on how they will be contacted and offered services by

the Part D Sponsor, including the comprehensive medication review

and targeted medication reviews, and a description of how the

reviews are conducted and delivered, including time commitments

and materials beneficiaries will receive; and

• A statement on how the enrollee may obtain MTM service

documents, including a blank copy of the Personal Medication List

posted on the website. A statement clarifying that these programs

are not considered a benefit.

100.2.2 – Required Documents for All Plans/Part D Sponsors

42 CFR 417.427, 422.111(a)(3), (b) and (h)(2), 423.128(a)(3), (b) and

(d)(2), 164.520(c)

Plans/Part D Sponsors must post the following materials on the Plan’s/Part D

Sponsor’s website:

• Summary of Benefits;

• Multi-Language Insert;

• Annual Notice of Change/Evidence of Coverage (most current version);

• Provider directory and/or pharmacy directory, as applicable (see

chapter 4 of the Medicare Managed Care Manual and chapter 5 of the

Medicare Prescription Drug Benefit Manual and the HPMS memo for

Online Provider/Pharmacy Directory requirements);

• Privacy Notice under the HIPAA Privacy Rule (privacy notices are

subject to enforcement by the Office for Civil Rights);

• CMS Star Ratings document;

• Any form developed to be used by physicians when providing a

supporting statement for an exceptions request;

• Any form developed by the Plan/Part D Sponsor to be used by a

physician or enrollee to satisfy a prior authorization or other utilization

management requirement; and

• All required translated materials identified in sections 30.6, 30.7, and

30.9, except in cases in which the translated documents will be sent to

specific enrollees (e.g., the LIS Rider) if Plans/Part D Sponsors have

service areas that meet the five (5) percent language threshold.

Plans/Part D Sponsors, including Section 1876 cost plans that do and do not

offer Part D benefits, must post the following information on the website by

September 30 for the upcoming contract year:

• Annual Notice of Change/Evidence of Coverage

• Provider and/or Pharmacy Directory

• Formulary and Utilization Management Documents

• Multi-Language Insert

The following are exceptions to the above requirement:

• Existing D-SNPs and MMPs that mail the ANOC and EOC separately

must post the ANOC by September 30 and the EOC by December 31.

All other information must be posted by September 30 as noted above.

• New plans must post the required documents, except the ANOC,

between October 1 and December 31.

CMS expects Plans/Part D Sponsors to post the following on the Plan/Part D

Sponsor website:

• Enrollment instructions and forms;

• Any form to be used by physicians when providing a supporting

statement for an exceptions request; and

• Any form to be used by a physician or enrollee to satisfy a prior

authorization or other utilization management requirement.

Additionally, Part D Sponsors must post the following documents:

• Current Comprehensive Formulary (see section 100.5 for detailed

requirements);

• Utilization Management Documents;

• Prescription Drug Transition Policy;

• LIS Premium Summary Chart; and

• CMS Part D Model Coverage Determination and Redetermination

Request Forms.

•

100.3 - Electronic Enrollment

Except as described below, all Plans/Part D Sponsors must accept enrollment

requests submitted through the Medicare Online Enrollment Center (OEC):

• The OEC is not available to individuals seeking enrollment in Medicare

Savings Account (MSA) plans and 800 series employer group waiver

plans; and

• SNPs, Section 1876 cost plans, and Religious Fraternal Benefit plans

may, but are not required to, accept enrollment requests through the

OEC.

Plans/Part D Sponsors may also develop and offer electronic enrollment

mechanisms that permit enrollment requests to be submitted via a Plan/Part

D Sponsor-owned electronic device or the Plan’s/Part D Sponsor’s secure

internet website. Plans/Part D Sponsors may obtain technical and related

services from outside entities in support of its online enrollment mechanism,

such as licensed software.

Plans/Part D Sponsors using enrollment software on Plan/Part D Sponsor-

owned mobile devices (e.g., smartphones or tablets) must submit the mobile

pages following the website submission guidance (see section 90.2.2).

Plans/Part D Sponsors may use downstream entities, such as an

agent/broker or third party website, as a means of facilitating enrollment

requests and capturing the enrollment request. However, Plans/Part D

Sponsors retain complete responsibility for the appropriate handling of any

sensitive beneficiary information provided as part of electronic enrollment,

including those portions of the process that are facilitated or managed by

downstream entities.

See Chapter 2 of the Medicare Managed Care Manual, Chapter 17d of the

Medicare Managed Care Manual, and Chapter 3 of the Medicare Prescription

Drug Benefit Manual for specific electronic enrollment requirements.

100.4 – Online Formulary, Utilization Management (UM), and Notice

Requirements

42 CFR 423.128(d)(2)(ii)

The online formulary must be the Part D Sponsor’s comprehensive formulary

and the Part D Sponsors must provide a definition of a comprehensive

formulary. It must display all information contained within the HPMS

approved formulary files and meet all the requirements of the model

comprehensive formulary. Part D Sponsors may make minor modifications to

address issues such as abbreviations and/or grammatical truncation.

The online formulary should be downloadable. Part D Sponsors may also

provide an online formulary search tool, but the search tool should not

substitute for the downloadable formulary.

The downloadable formulary, any search tools, and utilization management

documents are expected to:

• Be updated at least once per month; and

• Indicate when the document and search tool (if available) was last

updated by including the phrase, “Updated MM/YYYY” or “No changes

made since MM/YYYY”.

If a search tool is provided, it should be searchable by drug name. When

search results indicate a drug is not covered, it should provide an

explanation or a link to an explanation of how to obtain an exception to the

Part D sponsor’s formulary, utilization management tools, or (if applicable)

tiered cost sharing.

Part D Sponsors may include formulary and non-formulary alternatives;

however, the formulary alternatives are expected to be clearly marked as

formulary drugs without the need for further navigation. Each search result

that appears in the search tool is expected to:

• Indicate whether a drug is covered, its tier placement, and any

applicable utilization management requirements. If quantity limit

restrictions apply, the quantity limit amount and days’ supply is

expected to be displayed. If prior authorization or step therapy

restrictions are applicable, then the criteria are also expected to be

included.

• Include the following statement for drugs with a Part B versus Part D

administrative prior authorization requirement: “This drug may be

covered under Medicare Part B or Part D depending upon the

circumstances. Information may need to be submitted describing the

use and setting of the drug to make the determination.”

• When the online formulary search tool results indicate a drug is not

covered, explain or link to an explanation of how to obtain an

exception to the Part D sponsor’s formulary, utilization management

tools or tiered cost sharing both by an introductory screen and when

search results indicate a drug is not covered.

• Provide an indicator to identify mail-order availability, excluded drugs,

free first fill drugs, limited access drugs, drugs covered in the coverage

gap, and drugs covered under the medical benefit (for home infusion

drugs only).

Utilization management documents (detailing the criteria needed to satisfy

the prior authorization and/or step therapy requirements) and the transition

policy document are reviewed and approved as part of the HPMS formulary

review process and not the HPMS marketing process. See the Medicare

Prescription Drug Benefit Manual, Chapter 6, section 30.2.7

(http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html).

Part D Sponsors may post online the notice of formulary changes, provided

that it:

• Includes all changes associated with removing or changing a Part D

drug or adding authorization, quantity limits, step therapy, changing

the cost sharing status, or any other restrictions on a drug

• Meets all requirements for written notice specified in the Medicare

Prescription Drug Benefit Manual, Chapter 6, section 30.3.4

(http://www.cms.gov/Medicare/Prescription-Drug-

Coverage/PrescriptionDrugCovContra/PartDManuals.html). This

information must be maintained on the website until the next annual

mailing of the updated formulary.

100.5 – Social Media

42 CFR 422.111(h), 422.2264, 422.2268, 423.128(d), 423.2264, 423.2268

Plans/Part D Sponsors must submit to HPMS social media (e.g., Facebook,

Twitter, YouTube, LinkedIn, Scan Code, or QR Code) posts that meet the

definition of marketing materials, specifically those that contain plan-specific

benefits, premiums, cost-sharing, or Star Ratings.

Plans/Part D Sponsors must not include content on social/electronic media

that discusses plan-specific benefits, premiums, cost-sharing, or Star

Ratings for products offered in the next contract year prior to October 1.

If a Plan/Part D Sponsor posts required information (see sections 100.2 and

100.3) to a social media site, that information must also be posted on the

Plan’s/Part D Sponsor’s official website to comply with the disclosure

requirement. Both plan enrollees and members of the public should be able

to view the required information without having to join a third-party social

media website.

Additional guidance on social media has been incorporated into relevant

sections of the MMG. For example, see section 40.1 for information on social

media and material IDs, section 50 for information on social media and

disclaimers, and section 70.9 for information on requirements for virtual

sales/marketing events held through social media.

100.6 – Mobile Applications

42 CFR 422.2260, 422.2262, 422.2268, 423.2260, 423.2262, 423.2268

Mobile applications (apps) that provide information to current enrollees

about their current Plan or provide non-Plan-specific health information do

not require submission to HPMS for marketing review. If the app is targeted

to potential enrollees, it must be submitted in HPMS (see section 90.2 for

the material submission process). Plans/Part D Sponsors must also provide

CMS access to their mobile apps upon request.

If Plans/Part D Sponsors do not provide complete plan benefit, premium,

and co-payment information in the app, the selection of information must

not be misleading. The app must also instruct beneficiaries where to find

complete information.

If the mobile app contains provider and/or pharmacy directory information,

it must include and give equal prominence to all in-network

providers/pharmacies, although it may limit the information by geographic

area and/or by the search criteria. The app must clearly indicate if it limits

the information to a geographic area.

110 – Reserved

120 – Marketing and Sales Oversight and Responsibilities

120.1 – Compliance with State Licensure and Appointment Laws

42 CFR 422.2272(c), 423.2272(c)

Plans/Part D Sponsors must comply with applicable State licensure and/or

appointment laws when engaging with marketing representatives to sell

Medicare products.

120.2 – Plan Reporting of Terminated Agents

42 CFR 422.2272(c)-(e), 422.2274(f), 423.2272(c)-(e), 423.2274(f)

Plans/Part D Sponsors must immediately report the termination of any

agents/brokers to the State (adhering to state requirements for reporting

terminations to the state) and the reasons for the termination, if State law

requires the reasons to be reported. Plans/Part D Sponsors must report for-

cause terminations to CMS Account Managers, via email or letter. Plans/Part

D Sponsors must also report to CMS Account Managers any sales of

Medicare products, which were made by agents without a valid license.

If a Plan/Part D Sponsor discovers an enrollment application was submitted

by an unlicensed agent or broker, the Plan/Part D Sponsor must immediately

terminate the agent or broker and report this action to the state where the

application was submitted. Additionally, Plans/Part D Sponsors must notify

any beneficiaries who were enrolled by unqualified agents/brokers (e.g.,

unlicensed, not appointed, or has not completed the annual training/testing)

and advise those beneficiaries of the agents’/brokers’ status. Beneficiaries

may request to make a plan change under 42 CFR 422.62(b)(3)(i) or

423.38(c)(8)(i).

120.3 – Agent/Broker Training and Testing

42 CFR 422.2274(c) and (d), 423.2274(c) and (d)

Plans/Part D Sponsors must ensure that all agents/brokers

(employed/captive or independent) selling Medicare products are trained and

tested annually on Medicare rules, regulations, and on details specific to the

plan products that they sell. This means that training and testing must take

place prior to the broker/agent selling the product. In addition,

agents/brokers must obtain a passing score of at least eighty-five percent on

the test.

CMS provides updated guidance annually for agents/brokers training/testing.

Plans/Part D Sponsors must ensure that their agents/brokers training/testing

programs are designed and implemented in a way that maintains the

integrity of the training and testing, and must have the ability to provide this

information to CMS upon request.

120.4 - Compensation Applicability and Definitions

42 CFR 422.2274, 423.2274

All compensation requirements contained in this section apply to

independent agents/brokers. Agents/brokers employed by a Plan/Part D

Sponsor are exempt from compensation requirements, except where noted

(e.g., referral/finder fees). However, all other marketing and sales

requirements must be met.

Compensation:

Compensation includes monetary or non-monetary remuneration of any kind

relating to the sale or renewal of a policy including, but not limited to,

commissions, bonuses, gifts, prizes, awards, and referral/finder’s fees.

Compensation DOES NOT include:

• The payment of fees to comply with State appointment laws;

• Training;

• Certification;

• Testing costs;

• Reimbursement for mileage to, and from, appointments with

beneficiaries; or

• Reimbursement for actual costs associated with beneficiary sales

appointments such as venue rent, snacks, and materials.

Initial Compensation:

Initial compensation may be paid at or below the fair market value (FMV)

cut-off amounts published by CMS annually.

Renewal Compensation:

Renewal compensation may be paid for each enrollment in Year 2 and

beyond. Renewal compensation may be paid up to fifty (50) percent of the

current FMV, published by CMS annually.

Referral/Finder’s Fees:

Referral/Finder’s fees paid to agents and brokers, including independent,

employed, and captive agents and brokers, may not exceed $100 ($25 for

PDPs). This amount is not reasonably expected to provide enough financial

incentive for an agent or broker to recommend or enroll a beneficiary into a

plan that is not the most appropriate for the beneficiary’s needs.

Additionally, referral/finder’s fees paid to all agents and brokers must be part

of total compensation and must not exceed FMV for that contract year.

A “like plan type” enrollment includes:

• A PDP to another PDP

• An MA, MA-PD, or MMP to another MA, MA-PD, or MMP

• A Section 1876 cost plan to another Section 1876 cost plan

An “unlike plan type” enrollment includes:

• An MA or MA-PD plan to a PDP or section 1876 cost plan

• A PDP to a section 1876 cost plan or an MA (or MA-PD) plan

• A section 1876 cost plan to an MA (or MA-PD) plan or PDP

Note: For dual enrollments (e.g., enrollment in an MA-only plan and a

stand-alone PDP), the compensation rules apply independently to each

plan. However, when dual enrollments are replaced by an enrollment

in a single plan, compensation is paid based on the MA movement

(e.g., movement from an MA-only plan and PDP to an MA-PD plan

would be compensated at the renewal compensation amount for the

MA to MA-PD “like plan type” move).

120.4.1 – General Rules Regarding Compensation

42 CFR 422.2272(c)-(e), 422.2274(c) and (d), 423.2272(c)-(e),

423.2274(c) and (d)

Plans/Part D Sponsors may not pay compensation to agents/brokers that do

not meet state licensure/appointment requirements or those that have been

terminated for cause.

When a Plan/Part D Sponsor and/or a contracted independent agent/broker

terminates an agent/broker contract, any future payment of existing

business will be governed by the terms of the contract, subject to the limits

in the regulation.

Note: Non-agents/brokers receiving referral fees are not subject to the

general compensation rules (e.g., training/testing/licensure).

120.4.2 – Compensation Payment Requirements

42 CFR 422.2274(a), (b)(4), and (g), 423.2274(a), (b)(4), and (g), 422.516

(a)(6), 423.514 (a)(5)

Each year, Plans/Part D Sponsors may decide whether they are using

employed, captive, and/or independent agents, as well as the amount within

CMS’ FMV limits they will compensate independent agents/brokers. Each

year, CMS issues an HPMS memo that notifies Plans/Part D Sponsors of the

FMV, and requires them to inform CMS yearly by the end of July whether

they will use agents/brokers, including the types of agents/brokers, as well

as the compensation payment rates or ranges.

In addition, Plans/Part D Sponsors must have in place their full agent/broker

compensation structure for initial and renewal enrollments by October 1

each year. This structure supports the compensation payment rates or

ranges submitted earlier in the year and must be made available to CMS

upon request. The compensation structure must include details of how the

Plan/Part D Sponsor plans to disseminate compensation, including specifying

payment amounts for initial and renewal compensation. The compensation

structure must stay the same for the compensation year that was put in

place by October 1. This does not preclude Plans/Part D Sponsors from

entering into/re-negotiating, or modifying agent/broker contracts or

payment policies provided the payment rates fall within the specified

submitted ranges.

The agent/broker compensation year is January 1 to December 31.

Compensation payments must be calculated on a January to December

enrollment year. They may not be made on a rolling basis or on an

enrollment year basis. For example, if a beneficiary’s enrollment is effective

September 1, then the initial enrollment year for that beneficiary ends on

December 31 and the beneficiary’s “renewal” year would begin in January of

the following year. Plans/Part D Sponsors should consult the MARx

agent/broker compensation report to determine whether an initial or renewal

payment is appropriate. This report is automatically released and

disseminated monthly by the MARx system.

Plans/Part D Sponsors have the flexibility to make compensation payments

annually, quarterly, monthly, or by a different schedule. However,

compensation payments must be paid during the year of enrollment. In

other words, enrollments during the preceding year for effective dates

January 1 (or later) of the following year, should not be compensated until

January 1 or after. Payments for enrollments effective at any point during a

calendar year must be paid in full by December 31 of the calendar year of

enrollment. In addition, compensation payments should be based on the

number of months a beneficiary is enrolled during a calendar year.

Referral/finder’s fees may not exceed the amounts stated in section 120.4.

In addition, referral fees paid to agents must be part of total compensation,

not to exceed the FMV for initials and 50% of FMV for referrals.

Plans/Part D Sponsors that contract with third-parties to sell MA/Part D

products must ensure that compensation payments to these third-parties are

no greater than the Plans’/Part D sponsors’ initial and renewal compensation

amounts. Additionally, third parties must comply with agent broker

compensation guidelines.

Initial Compensation is paid:

• The beneficiary’s first year of enrollment in any plan (MA, PDP,

MA-PD, Cost) where the MARx report has a prior plan type of

None;

• A beneficiary moves from an employer group plan to a non-

employer group plan (either within the same Parent Organization

or between Parent Organizations);

• A beneficiary changes plans during their initial enrollment year;

• A beneficiary makes an “unlike plan change.”

Initial Compensation may be paid in full or pro-rated for:

• The beneficiary’s first year of enrollment in any plan (MA, PDP,

MA-PD, Cost) where the MARx report has a prior plan type of

None; or

• A beneficiary moves from an employer group plan to a non-

employer group plan (either within the same Parent Organization

or between Parent Organizations).

Initial Compensation must be pro-rated when:

• A beneficiary enrolls in an “unlike plan type,” during their

renewal year; or

• A beneficiary changes plans during their initial enrollment year.

Renewal compensation may be paid to agents/brokers under the following

three scenarios:

• Following the initial year compensation;

• A beneficiary enrolls in a new “like plan” within the same Parent

Organization or between two different Parent Organizations; or

• A beneficiary enrolled in an MMP switches to an MA plan or an

MA-PD plan (and vice versa), if applicable per state MMP policy.

Renewal Compensation must always be pro-rated.

Other compensation scenarios are highlighted below:

Only

the MA compensation amount should be paid when a

beneficiary enrolls in an MA-PD plan, not the MA compensation

amount

and

the PDP compensation amount.

When a beneficiary enrolls in both a Section 1876 cost plan and

a stand-alone PDP, compensation should be paid for both

enrollments.

120.4.3 – Compensation Recovery Requirements (Charge-backs)

42 CFR 422.2274(a)(4)(ii), 423.2274(a)(4)(ii)

Plans/Part D Sponsors must recover compensation payments from

agents/brokers under two circumstances: 1) a beneficiary disenrolls from a

plan within the first three months of enrollment (rapid disenrollment), and 2)

any other time a beneficiary is not enrolled in a plan.

CMS expects Plans/Part D Sponsors to retroactively pay or recoup funds

based on retroactive beneficiary changes (retroactive

enrollment/disenrollment) for the current calendar year and the previous

calendar year. Plans/Part D Sponsors are not required to recoup or pay

compensation for years prior to the previous calendar year. However, if a

Plan/Part D Sponsor chooses to recoup payments from a prior calendar year,

it must also pay funds retroactively that would have been due during that

same year.

Rapid Disenrollment

• Rapid disenrollment applies when an enrollee moves from one Parent

Organization to another Parent Organization, or when an enrollee

moves from one plan to another plan within the same Parent

Organization.

• Rapid disenrollment compensation recovery does not apply when a

beneficiary enrolls in a Plan/Part D Sponsor effective October 1,

November 1, or December 1, and subsequently uses the Annual

Election Period to make changes to their current plan for an effective

date of January 1 of the following year. If, however, a beneficiary

enrolls for October 1, November 1 or December 1 and disenrolls from

the plan (unrelated to the AEP), the Plan/Part D Sponsor should

recover compensation based on the rapid disenrollment.

• Rapid disenrollment compensation recovery does not apply when CMS

determines that recoupment is not in the best interests of the

Medicare program. Such situations include when a beneficiary

disenrolls within the first three months for any of the following

reasons:

• Other creditable coverage;

• Moving into or out of an institution;

• Gains/drops employer/union sponsored coverage;

• CMS sanction against the plan/contract violation;

• Plan terminations and non-renewals;

• In order to coordinate with Part D enrollment periods;

• In order to coordinate with a State Pharmaceutical Assistance

Program;

• Becoming dually eligible for both Medicare and Medicaid;

• Qualifying for another plan based on special needs;

• Becoming LIS eligible;

• Qualifying for another plan based on a chronic condition;

• Due to an auto, facilitated, or passive enrollment;

• Death;

• Moves out of the service area;

• Non-payment of premium;

• Loss of entitlement;

• Retroactive notice of Medicare entitlement; or

• When moving to a plan with a 5-star rating or from an LPI

plan into a higher rated plan.

Other Compensation Recovery

• Plans/Part D Sponsors must recover a pro-rated amount of initial

compensation when an enrollee disenrolls from a plan. The amount

recovered must be equal to the number of months not enrolled. For

example, an enrollee ages in effective April 1. The enrollee disenrolls

effective September 30 of the same year. The plan initially paid a full

initial compensation. Since the enrollee disenrolled (not a rapid

disenrollment), the Plan/Part D Sponsor must recover from the agent

or broker 6/12ths of the initial compensation (January through March

and October through December).

• Plans/Part D Sponsors must recover a pro-rated amount of renewal

compensation when an enrollee disenrolls from a plan. This amount

must be equal to the number of months not enrolled. For example, a

renewal enrollee disenrolls effective February 28. The Plan/Part D

Sponsor must recover from the agent or broker 10/12ths of the

renewal payment if the renewal payment had been paid for the entire

12-month period.

• Plans/Part D Sponsors have the option to pay the agent or broker

either full or pro-rated compensation for initial enrollments that are

effective later than January 1 and the enrollees have no prior plan

history. However, if the Plan/Part D Sponsor pays a full initial

compensation and the enrollee disenrolls during the contract year, the

Plan/Part D Sponsor must recoup a pro-rated amount for all months

the beneficiary is not enrolled, regardless of whether it is a change

from one Parent Organization to another Parent Organization or from

one PBP in one organization to another PBP within the same

organization. This would include months prior to the enrollment. For

example, a beneficiary ages into Medicare and elects an MA-PD plan

(Plan A), effective April 1. The beneficiary moves and is eligible for a

special enrollment period. The beneficiary elects a new MA-PD (Plan

B), effective November 1. Plan A must recoup 5/12ths of the initial

compensation (January through March and November through

December) to account for the months the beneficiary was not enrolled

in Plan A. Since the beneficiary had prior plan history when enrolled in

Plan B, Plan B may only pay a pro-rated initial compensation equal to

2/12ths (November through December).

• Plans/Part D Sponsors must recover from the agent or broker a pro-

rated amount of compensation when there is a “like plan change” from

an MA or MA-PD to MMP. Compensation is not to be paid for the

months the enrollee is in the MMP for that compensation cycle year.

For example, a renewal enrollee makes a “like plan type” change from

an MA to MMP effective July 1 of the compensation cycle year. The MA

Plan must recover 6/12ths of the renewal payment.

120.4.4 – Payments other than Compensation

42 CFR 422.2274, 423.2274

Payments made to third parties for services other than enrollment of

beneficiaries (e.g., training, customer service, or agent recruitment) must

not exceed FMV and must not exceed an amount that is commensurate with

the amounts paid by the Plan/Part D Sponsor to a third party for similar

services during each of the previous two (2) years.

120.5 – Additional Marketing Fees

42 CFR 422.2274, 423.2274

A Plan/Part D Sponsor may not charge a beneficiary or allow its marketing

representatives to charge a beneficiary a marketing fee. All costs associated

with the marketing of a plan are the responsibility of the Plan/Part D

Sponsor.

120.6

–

Activities That Do Not Require the Use of State-Licensed Marketing

Representatives

42 CFR 422.2272(c), 423.2272(c)

The following activities conducted by a plan customer service representative

do not require the use of State-licensed marketing representatives, unless

otherwise stated by state law. These include:

• Providing factual information;

• Fulfilling a request for materials;

• Taking demographic information in order to complete an enrollment

application at the initiative of the prospective enrollee;

• “For-cause” review of materials and activities when complaints are

made by any source, and CMS determines it is appropriate to

investigate; and

• “Secret shopper” activities where CMS requests Plan/Part D Sponsor

materials such as enrollment packets.

However, if Plans/Part D Sponsors use licensed agents/brokers (employed or

contracted) as customer service representatives, they cannot act as both a

customer service representative and a sales/marketing agent/broker.

130 - Employer/Union Group Health Plans

Sections 1857(i) and 1860D-22(b) of the Social Security Act, 42 CFR

422.2276, 423.458, 423.2276

Plans offering employer group health plans are not required to submit

informational copies of their dissemination materials to CMS at the time of

use. However, as a condition of CMS providing particular waivers or

modifications to employer group plans, CMS reserves the right to request

and review these materials in the event of beneficiary complaints or for any

other reason it determines to ensure the information accurately and

adequately informs Medicare beneficiaries about their rights and obligations

under the plan.

CMS waivers to employer group plans are limited in scope to their stated

parameters, and employer group waiver plans must follow all Part C and D

rules unless explicitly waived. For specific guidance regarding these waivers

or modifications of marketing and disclosure/dissemination of information

requirements for employer/union-sponsored group health plans, please refer

to Chapter 9 of the Medicare Managed Care Manual, and Chapter 12 of the

Medicare Prescription Drug Benefit Manual.

Table 130.1 - Marketing Provisions – Employer/Union Group Plans

Marketing Provisions that apply to Employer/Union Group Plans

These requirements are applicable for the transaction between the

agent/broker selling the plan to the employer/union. All activities

conducted by the employer/union or its designees to sign up individual

employees to the plan(s) selected by the employer/union are excluded

from these provisions.

Note: This table contains a partial list of exclusions.

Applicable Provisions

(Not Waived)

Not Applicable Provisions

(Waived)

Nominal Gifts

Unsolicited Contacts

Sales/Marketing in Health Care

Settings

Cross-selling

Sales/Marketing at Educational

Events

Scope of Appointments

Co-branding

Provision of Meals

Appointment of Agents/Brokers

Agent/Broker Compensation

State Licensed

Agent/Broker Testing

Reporting of Terminated

Agents/Brokers

Agent/Broker Training

Agents must be thoroughly

familiar with the products they are

selling, including the plan specific

details and the Medicare rules that

apply to the specific products. The

organization/sponsor is

responsible for ensuring that the

agents selling for them have

sufficient knowledge.

140 – Reserved

150 – Use of Medicare Mark for Part D Sponsors

Section 1140 of the Social Security Act

All Part D Sponsors must sign a licensing agreement to use the official

Medicare Mark via the HPMS contracting module. All applicant and renewing

Part D sponsors sign the Medicare Mark licensing agreements via the HPMS

electronic signature process. The license agreement is effective for a single

contract year and Part D sponsors must renew annually to continue using

the Medicare Mark.

150.1 – Authorized Users for Medicare Mark

Section 1140 of the Social Security Act

All Part D Sponsors are authorized to use the Medicare Prescription Drug

Benefit Program Mark only after electronically executing the Medicare Mark

License Agreement in HPMS. In certain circumstances, the Medicare Mark

License Agreement may be signed in hard copy rather than electronically.

Only a CEO, CFO, or COO who is designated as an authorized signer in HPMS

is eligible to execute the Medicare Mark License Agreement. Part D Sponsors

may use the mark on marketing materials consistent with this chapter.

Unless otherwise approved, no individuals, organizations, and/or commercial

firms may distribute materials bearing the Medicare Prescription Drug

Benefit Program Mark.

150.2 – Use of Medicare Prescription Drug Benefit Program Mark on Items

for Sale or Distribution

Section 1140 of the Social Security Act

All Part D Sponsors may use the Medicare Prescription Drug Benefit Program

Mark on items they distribute, provided the item(s) follow(s) guidelines for

nominal gifts, as provided in Appendix 1 and section 70.1.1. Items with the

Medicare Prescription Drug Benefit Program Mark cannot be sold for profit.

150.3 – Approval to Use the Medicare Prescription Drug Benefit Program

Mark

Section 1140 of the Social Security Act

The process to grant authorized users access to the Medicare Prescription

Drug Benefit Program Mark for use on Part D marketing materials is

described below:

1. The Part D Sponsor electronically signs the Medicare Mark License

Agreement in HPMS (or signs a hardcopy, as applicable);

2. CMS counter-signs the Part D Sponsor’s contract; and

3. CMS sends the Medicare Mark URL to the Part D Sponsor.

After receipt of the URL, organizations may begin using the mark on

marketing materials (including the Part D membership ID card) that are

required to be submitted to CMS for review.

Requests to distribute other items (materials that are not included in this

chapter) bearing the Medicare Prescription Drug Benefit Program Mark must

be submitted to CMS at least thirty (30) days prior to the anticipated date of

distribution. Requests should be sent to:

Office of the Administrator/Office of Communications Visual & Multimedia

Communications Group

7500 Security Blvd.

Baltimore, MD 21244-1850

Once a request has been approved the following will apply: 1) approval will

be effective for a period not to exceed one year; and 2) approval will be

granted only for those items for which use of the mark was requested in the

request letter and for which written approval was granted.

150.4 – Prohibition on Misuse of the Medicare Prescription Drug Benefit

Program Mark

Section 1140 of the Social Security Act

42 U.S.C. section 1320b-10 prohibits the misuse of the Medicare name and

marks. In general, it authorizes the Inspector General of the Department of

Health and Human Services (DHHS) to impose penalties on any person who

misuses the term Medicare or other names associated with DHHS in a

manner which the person knows or should know gives the false impression

that it is approved, endorsed, or authorized by DHHS. Offenders are subject

to fines of up to $5,000 per violation or in the case of a broadcast or telecast

violation, $25,000.

150.5 – Mark Guidelines

Section 1140 of the Social Security Act

The Medicare Prescription Drug Benefit Program Mark is a logotype

comprised of the words Medicare Rx with the words Prescription Drug

Coverage directly beneath.

Always use reproducible art available electronically. Do not attempt to

recreate the Program Mark or combine it with other elements to make a new

graphic. Artwork will be supplied in .EPS, .TIFF or .JPG format after

notification of approval into the program. Other file formats are available

from CMS’s Office of External Affairs upon request.

150.5.1 – Mark Guidelines - Negative Program Mark

Section 1140 of the Social Security Act

The Medicare Prescription Drug Benefit Program Mark may be reversed out

in white. The entire mark must be legible.

150.5.2 – Mark Guidelines - Approved Colors

Section 1140 of the Social Security Act

The two (2)-color mark is the preferred version. It uses PMS 704 (burgundy)

and sixty-five (65) percent process black. It is recommended that if the CMS

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mark is used in conjunction with the brand mark, that the black versions of

those logos be used.

The 1-color version in grayscale is acceptable. The mark elements are one-

hundred (100) percent black except for the word “Medicare” which is fifty-

five (55) percent black.

The 1-color version in one-hundred (100) percent black also is acceptable.

150.5.3 – Mark Guidelines on Languages

Section 1140 of the Social Security Act

The Spanish version of the Medicare Prescription Drug Benefit Program Mark

may be used in place of the English language version on materials produced

entirely in Spanish. The two (2)-color version is preferred, but the grayscale,

black and negative versions may be used.

150.5.4 – Mark Guidelines on Size

Section 1140 of the Social Security Act

To maintain clear legibility of the Program Mark, never reproduce it at a size

less than one (1) inch wide. The entire mark must be legible.

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150.5.5 – Mark Guidelines on Clear Space Allocation

Section 1140 of the Social Security Act

The clear space around the Medicare Prescription Drug Benefit Program Mark

prevents any nearby text, image or illustration from interfering with the

legibility and impact of the mark. The measurement “x” can be defined as

the height of the letter “x” in “Rx” in the Program Mark. Any type or graphic

elements must be at least “x” distance from the mark as shown by the

illustration.

150.5.6 – Mark Guidelines on Bleed Edge Indicator

Section 1140 of the Social Security Act

The Program Mark may not bleed off any edge of the item. The mark should

sit at least one-eighth (1/8) inch inside any edges of the item.

150.5.7 – Mark Guidelines on Incorrect Use

Section 1140 of the Social Security Act

Following are rules for preventing incorrect use of the Medicare Prescription

Drug Benefit Program Mark:

• Do not alter the position of the mark elements;

• Do not alter the aspect ratio of the certification mark. Do not stretch or

distort the mark;

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• Always use the mark only as provided in the CMS approval/license

agreement;

• Do not rotate the mark or any of its elements;

• Do not alter or change the typeface of the mark;

• Do not alter the color of any of the mark elements;

• Do not position the mark near other items or images. Maintain the

clear space allocation;

• Do not position the mark to bleed off any edge. Maintain one-eight

(1/8) inch safety from any edge;

• Do not use any of the mark elements to create a new mark or graphic;

and

• Do not use the mark on background colors, images or other artwork

that interfere with the legibility of the mark.

150.6 – Mark Guidelines for Part D Standard Pharmacy ID Card Design

Section 1140 of the Social Security Act

Usage of the Medicare Prescription Drug Benefit Program Mark on an ID Card

must be consistent with section 60.2 of the MMG.

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160 – Allowable Use of Medicare Beneficiary Information Obtained from CMS

In addition to limits CMS places on the data it provides to Plans/Part D

Sponsors, compliance with the HIPAA privacy and security rules (45 CFR

Parts 160, 164) may require greater protection of information from and/or

about enrollees. Plans/Part D Sponsors should also consult with their counsel

and the many resources offered by the HHS’ Office for Civil Rights (OCR) to

ensure their compliance with the HIPAA requirements. CMS does NOT

provide guidance on HIPAA privacy and security compliance; the OCR

provides such guidance. These Marketing Guidelines are about compliance

with CMS and Medicare requirements only. For information on HIPAA privacy

and security requirements, please visit:

http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/privac

yguidance.html

All MA, Part D, PACE, and Section 1876 cost plans sign a data use

attestation under which they agree that they will restrict the use of Medicare

data to those purposes directly related to the administration of the Medicare

managed care and/or outpatient prescription drug benefits for which they

have contracted with CMS to administer. Plans/Part D Sponsors also agree

not to use that information to develop, market, or operate lines of business

unrelated to their Medicare plan operations.

For purposes of these Data Use Attestations, CMS-provided data includes

information provided by beneficiaries in the course of their enrollment in a

Medicare plan as well as data obtained solely as a result of access to CMS

systems granted to the contracting organization or sponsor because it is a

Part C, Part D, PACE or Section 1876 cost plan contractor. Except in cases in

which the enrollee gave information as part of a commercial relationship

prior to enrollment in the Medicare plan, the contracting organization or

sponsor was only given the information on the application as a result of the

contract with CMS.

While Plans/Part D Sponsors with a previous commercial relationship with

Medicare beneficiaries (and employers offering Medicare plans) may have

obtained personal data through that relationship, and therefore are not

obligated to follow the Data Use Agreement in connection with such data, we

encourage Plans/Part D Sponsors to follow these data use guidelines as a

good business practice for protecting beneficiaries from potentially

unwelcome marketing and other communications. Examples of what is

considered a previous commercial relationship include membership in such

products as:

• Long-term care insurance;

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• Life-insurance policies;

• Non-Medicare employer or retiree plans; or

• Medigap policies.

While it is important to protect Medicare beneficiaries from potentially

unwelcome marketing and other communications, we also recognize

Plans’/Part D Sponsors’ interest in contacting their enrollees on issues

unrelated to the specific plan benefit that they contract with CMS to provide.

This section contains additional guidance for Plans/Part D Sponsors on the

distribution of other types of non-plan related information.

160.1 – When Prior Authorization from the Beneficiary Is Not Required

Plan/Part D Sponsor marketing materials describing health-related lines of

business to current enrollees do not require prior authorization (See section

40.8 for additional information). Examples of health-related information that

do not require prior authorization include:

• Long-term care insurance;

• Separate dental or vision policies;

• Information about current plan coverage or other Medicare products

offered by the Plan/Part D Sponsor;

• Plan and health information in monthly newsletters;

• Information on disease management programs;

• Mailings describing benefits changes; and

• Information on Medicaid and other community or social services

program.

160.2 – When Prior Authorization from the Beneficiary Is Required

To comply with CMS and Medicare policies and rules, Plans/Part D Sponsors

must obtain authorization from an enrollee prior to using or disclosing the

enrollee’s protected health information for marketing purposes. Examples of

non-health related issues plans may communicate after receiving prior

authorization (“opt-in”) of current enrollees include:

• Accident-only policies;

• Life insurance policies;

• Annuities;

• Volunteer or community activities;

105

• Pending State or Federal legislation; and

• Joining grassroots advocacy organizations and information about such

advocacy.

160.3 – Obtaining Prior Authorization

To comply with CMS and Medicare policies and rules, Plans/Part D Sponsors

must receive the enrollee’s “opt-in” authorization prior to sending any non-

plan or non-health related information. Plans/Part D Sponsors should keep

evidence of authorization for audit purposes. Following are examples of how

the authorization required under section 160.2 may be obtained.

• Plans/Part D Sponsors may send, at their own expense, written

authorization “opt-in” forms to enrollees.

• Plans/Part D Sponsors may direct an enrollee to a website to provide

consent. If the Plan/Part D Sponsor uses a website for the “opt-in”

process, the link from the plan’s Medicare product website must inform

the enrollee that he or she is leaving the Medicare product website and

going to the non-Medicare product website, as provided in section

100.1. Once a beneficiary “opts-in,” the Plans/Part D Sponsors must

be clear that the enrollee will receive additional information that may

be non-plan or non-health related.

• Enrollees can complete a written authorization in person at marketing

events, health fairs, or other public venues.

• Enrollees can complete the authorization over the telephone, provided

the authorization is recorded. The call must be a enrollee-initiated

inbound telephone call and scripts for such calls must comply with all

guidance in section 80.

• Enrollees can complete the authorization via an email to the plan,

provided that the authorization includes an electronic signature.

Regardless of the method by which the authorization is obtained (e.g.,

written, telephonic, on a website), the following rules apply:

• The request must include one or more types of information for which

authorization is being sought. If authorization is being sought for more

than one type of information, a check box (or verbal agreement, if a

telephonic authorization) needs to be assigned to each type of

information. Furthermore, the type of information can only be

described in general terms. For example, “Check the boxes of the

types of information you would like to receive: life insurance, long-

106

term care insurance, pending State and Federal legislation, grass-roots

advocacy.”

• The request for authorization should not include any non-plan or non-

health related content, nor should it be included in the same mailing

as information on non-health related issues, unless the Plan/Part D

Sponsor has previously received prior authorization to send that

particular non-health related information to that enrollee. For example,

a request for authorization to send information about life insurance

should not include a statement like “Make sure your spouse’s future is

secure, with a life insurance policy from us,” and/or should not be sent

with documents that include details about the life insurance policy.

• The request for authorization can be included in the same mailing as

plan-related or health-related mailings to enrollees, as provided in the

MMG. The request for authorization may not be included on the

enrollment form (whether in hard copy or in electronic forms available

via the plan’s website) or made during the processing of a telephonic

enrollment.

• The request for authorization should not be confusing or misleading to

enrollees by purporting to have current plan benefit information or by

suggesting that the content includes official information from the

Medicare program.

• These requests for authorization are not subject to review by CMS, and

should not be submitted in HPMS. However, per section 20, Plans/Part

D Sponsors are still responsible for ensuring that all materials intended

for Medicare beneficiaries meet the requirements of this chapter and

applicable law (e.g., the HIPAA Privacy Rule), and for maintaining such

materials so as to make them available, through HPMS or other

means, upon CMS’ request.

Compliance with the HIPAA privacy and security rules (45 CFR Parts 160,

164) may require greater protection of information from and/or about

enrollees. Plans/Part D Sponsors should also consult with their counsel and

the many resources offered by the HHS’ Office for Civil Rights (OCR) to

ensure their compliance with the HIPAA requirements. CMS does NOT

provide guidance on HIPAA privacy and security compliance; the OCR

provides such guidance. Additional details on what is required for an

acceptable attestation can be found at 45 CFR 164.508.

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160.4 – Sending Non-plan and Non-health Information Once Prior

Authorization is Received

Non-plan and non-health related content can be provided to enrollees once

prior authorization is received.

• Non-health related content cannot be delivered with plan-related

materials, including in mailings, on websites, or during outbound

telephone calls related to current plan information.

In addition, these materials should include the disclaimer, “Medicare has

neither reviewed, nor endorses, this information.”

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Appendix 1 – Definitions

422.111, 422.2260, 423.2260, 422.2268, 423.128, 423.2268

The following definitions apply for purposes of the MMG only.

Ad Hoc Enrollee Communication Materials

Ad hoc enrollee communication materials are informational materials that

are targeted to current enrollees, are customized or limited to a subset of

enrollees, apply to a specific situation or cover enrollee-specific claims

processing or other operational issues, and do not include information about

the plan’s benefit structure. In addition, these communication materials are

not tied to regularly occurring events such as aging into Medicare, the

Annual Enrollment Period, or a new contract year. These materials are not

considered marketing materials. Examples include, but are not limited to,

the following:

• Letters about a shortage of formulary drugs due to a manufacturer

recall letter;

• Letters to communicate that an enrollee is receiving a refund or is

being billed for underpayments;

• Letters describing enrollee-specific claims processing issues; or

• Correspondence pertaining to unique questions or issues that affect an

individual or small subset of the plan’s enrollment.

Note: Enrollment/disenrollment materials are not considered ad hoc

enrollee communications.

Advertising

Advertising materials are primarily intended to attract or appeal to a

potential Plan/Part D Sponsor enrollee. Advertising materials contain less

detail than other marketing materials, and may provide benefit information

at a level to entice a potential enrollee to request additional information.

Alternate Formats

Alternate formats are used to convey information to individuals with visual,

speech, physical, hearing and intellectual disabilities (e.g., braille, large

print, audio).

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Banner and Banner-Like Advertisements

Banner advertisements are typically used in television ads, and flash

information quickly across a screen for the sole purpose of enticing a

prospective enrollee to contact the Plan/Part D Sponsor to enroll or obtain

more information. A “banner-like” advertisement is usually in some media

other than television, e.g., outdoor advertising and internet banner ads.

Banner advertisements are intended to be brief and to entice someone to

call the Plan/Part D Sponsor or to alert someone that information is

forthcoming.

Co-Branding

Co-branding is defined as a relationship between two or more separate legal

entities, one of which is an organization that sponsors a Medicare plan. Co-

branding is when a Plan/Part D Sponsor displays the name(s) or brand(s) of

the co-branding entity or entities on its marketing materials to signify a

business arrangement. Co-branding arrangements allow a Plan/Part D

Sponsor and its co-branding partner(s) to promote enrollment in the plan.

Co-branding relationships are entered into independent of the contract that

the Plan/Part D Sponsor has with CMS.

Direct mail

Direct mail is information sent to an individual to attract his/her attention or

interest and allow him/her to request additional information.

Educational Event

Educational events are designed to inform Medicare beneficiaries about

Medicare Advantage, Prescription Drug or other Medicare programs and do

not include marketing (i.e., the event sponsor does not steer, or attempt to

steer, potential enrollees toward a specific plan or limited number of plans).

Enrollment Materials

Enrollment materials are materials used to enroll or disenroll a beneficiary

from a plan, or materials used to convey information specific to enrollment

and disenrollment issues such as enrollment and disenrollment notices.

Health Plan Management System (HPMS) Marketing Module

Plans/Part D Sponsors must submit marketing materials for review through

the HPMS Marketing Module, which is an automated tool used to enter,

track, and maintain materials submitted to CMS for review and approval.

The HPMS Marketing Module User Guide provides extensive information on

how to use HPMS. Plans/Part D Sponsors should refer to the User Guide for

any questions regarding the Marketing Module or how to submit materials in

HPMS.

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Joint Enterprise

A joint enterprise is a group of organizations that are State-licensed as risk-

bearing entities that jointly enter into a single contract with CMS to offer a

Regional Preferred Provider Organization (RPPO) plan or PDP in a multi-State

region. The participating organizations contract with each other to create a

single “joint enterprise” and are considered an “entity” for purposes of

offering a RPPO or PDP.

Marketing

Marketing is the act of steering, or attempting to steer, a potential enrollee

towards a plan or limited number of plans, or promoting a plan or a number

of plans.

Marketing Materials

Marketing materials include any informational materials targeted to Medicare

beneficiaries which:

(1) Promote the Plan/Part D Sponsor, or any Plan/Part D Sponsor

offered by the MA organization;

(2) Inform Medicare beneficiaries that they may enroll, or remain

enrolled in, a Plan/Part D Sponsor offered by the MA organization;

(3) Explain the benefits of enrollment in a Plan/Part D Sponsor, or

rules that apply to enrollees; or

(4) Explain how Medicare services are covered under a Plan/Part D

Sponsor, including conditions that apply to such coverage.

Marketing materials exclude ad hoc enrollee communications materials.

Marketing/Sales Event

Marketing/sales events are events designed to steer, or attempt to steer,

potential enrollees toward a plan or a limited set of plans.

Marketing Appointments

Marketing appointments are individual appointments designed to steer or,

attempt to steer, potential enrollees toward a plan or limited number of

plans. All individual appointments between an agent and a beneficiary are

considered marketing/sales appointments regardless of the content

discussed.

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Medication Therapy Management (MTM) program materials

MTM program materials are:

o Materials provided to enrollees enrolled in the MA or PDP plan

who are eligible for the plan’s MTM program;

o Materials as a result of MTM services that address issues unique

to individual enrollees; and

o The Part D MTM program comprehensive medication review

summary in CMS’ standardized format that is provided to a

beneficiary.

Note: MTM program materials must not include any marketing

messages, or promotional messages.

Model Document

Model documents are materials for which CMS has provided model language

which, when used without modification, qualifies for a 10-day review or for

submission through the File & Use process.

Multi–Contract Entities (MCE)

MCE is a designation available for Plans/Part D Sponsors that have multiple

MA/PDP contracts with CMS. Being designated as an MCE allows a Plan/Part

D Sponsor to submit template materials to CMS that are representative of all

or a selection of the Plan’s/Part D Sponsor’s contracts.

Nominal Value

Nominal value is defined as an individual item/service worth $15 or less

(based on the retail value of the item).

Outdoor Advertising (ODA)

Outdoor advertising is outdoor marketing material intended to capture the

attention of a passing audience (e.g., billboards, signs attached to

transportation vehicles), and to influence them to request more detailed

information on the product being advertised.

Post-Enrollment Marketing Materials

Post-enrollment marketing material is a subset of marketing materials used

by a Plan/Part D Sponsor to convey benefits or operational information to

current enrollees.

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Pre-Enrollment Marketing Materials

Pre-enrollment marketing material is a subset of marketing materials used

prior to enrollment. Pre-enrollment materials may contain plan rules and/or

benefit information.

Promotional Activities

Promotional activities are activities performed by a Plan/Part D Sponsor, or

by an individual or organization on a Plan’s/Part D Sponsor’s behalf, to

inform current and potential enrollees of the products available.

Scripts

Scripts are standardized text. Informational scripts are designed to respond

to beneficiary questions and requests and provide objective information

about a plan or the Medicare program. Sales and enrollment scripts are

intended to steer a beneficiary towards a plan or limited number of plans, or

to enroll a beneficiary into a plan.

Standardized Language

Standardized language is language developed by CMS or another Federal

agency that is mandatory for use by the Plan/Part D Sponsor and cannot be

modified except as noted by CMS (e.g., ANOC/EOC, SB, Plan Ratings).

State Pharmaceutical Assistance Program (SPAP)

An SPAP is a state program which helps pay drug plan premiums and/or

other drug costs for people with Medicare.

Template Materials

Template materials are any marketing materials that include

placeholders for variable data to be populated at a later time.

Third Party Marketing Organization (TMO)

Third-party marketing organizations are entities such as a Field Marketing

Organization (FMO), General Agent (GA), or similar type of organization that

has been retained to sell or promote a Plan’s/Part D Sponsor’s Medicare

products on the Plan’s/Part D Sponsor’s behalf either directly or through

sales agents or a combination of both.

Value Added Items and Services (VAIS)

Value-Added Items and Services (VAIS) are items and services that are not

plan benefits, are not part of the Plans’/Part D Sponsor’s benefit package

and may not be marketed to prospective enrollees, or used as an

inducement or incentive for enrollment. VAIS are non-Medicare covered

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services or items, typically discounts, offered by a VAIS provider to the

enrollees of an MA plan.

Note: VAIS information cannot be included in or bound with materials

intended for prospective enrollees, or posted on parts of the website

directed at prospective enrollees.

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Appendix 2 – Related Laws and Regulations

(Not an exhaustive list)

Americans with Disabilities Act of 1990

Federal agencies must provide notice concerning the need for reasonable

accommodation for its beneficiaries, as well as providing those

accommodations.

Use of the Medicare Name

Section 1140 of the Social Security Act

Under Section 1140 of the Social Security Act, 42 U.S.C. 1320b–10, it is

forbidden for any person to use words or symbols, including “Medicare,”

“Centers for Medicare & Medicaid Services,” “Department of Health and

Human Services,” or “Health & Human Services” in a manner that would

convey the false impression that the business or product mentioned is

approved, endorsed, or authorized by Medicare or any other government

agency. This rule extends to Plans, Part D sponsors, and downstream

contractors that may be directly or indirectly involved in marketing Medicare

plans. Plans/Part D Sponsors should ensure that their subcontractors are not

using the Medicare name in a misleading manner.

Privacy and Confidentiality

42 CFR 422.118, 423.136

Plans/Part D Sponsors and providers must follow all Federal and State laws

regarding confidentiality and disclosure of patient information to Plans/Part

D Sponsors for marketing purposes. This obligation includes compliance with

the provisions of the HIPAA Privacy Rule and its specific rules regarding uses

and disclosures of beneficiary information. HIPAA and privacy documents

(e.g., a HIPAA/privacy document for a beneficiary’s signature in a provider’s

office) are not considered marketing documents and therefore do not need

to be submitted in HPMS. Refer to section 20 regarding materials not subject

to review.

Additional information on the HIPAA Privacy Rule and its disclosure

requirements can be found at http://www.hhs.gov/ocr/privacy/.

Telephonic Contact

Federal Trade Commission’s Requirements for Sellers and Telemarketers

apply including:

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• Federal Communications Commission rules and applicable State law;

• National-Do-Not-Call Registry;

• “Do not call again” requests; and

• Federal and State calling hours.

Use of Federal Funds

Division F, Title V, section 503(b), Departments of Labor, HHS, and

Education Appropriations Act, 2009, as enacted by section 5, Omnibus

Appropriations Act, 2009, Pub. L. 111-8, 123 Stat. 524, 802 (March 11,

2009)

CMS prohibits the use of Federal funds for non-plan related activities that

are designed to influence State or Federal legislation or appropriations, by

MAOs, Part D sponsors, Section 1876 cost plans, PACE plans, and MA

demonstration plans. Specifically, the Department of Health and Human

Services’ Annual Appropriations Acts states that no appropriated funds may

be used to pay the “salary or expenses of any grant or contract recipient, or

agent acting for such recipient, related to any activity designed to influence

legislation or appropriations pending before the Congress or any State

legislature.”

Section 508 of the Rehabilitation Act

Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the

Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998

All Plans/Part D Sponsors must have an internet website that is compliant

with web-based technology and information standards for people with

disabilities as specified in section 508 of the Rehabilitation Act. For additional

information, please go to the following website address:

http://www.section508.gov.

Note: These Federal requirements are extended to all Plans/Part D

Sponsors through the requirements for non-discrimination under

Federal grants and programs (29 USC 794).

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Section 504 of the Rehabilitation Act

All Plans/Part D Sponsors must ensure effective communication with

individuals with disabilities and to provide auxiliary aids and services, such

as alternate formats (e.g., braille, audio, large format), to individuals with

disabilities to ensure an equal opportunity to access the agencies’ programs.

These and other prohibitions against discrimination based on disability can

be found in the DHHS Section 504 regulation at 45 CFR Part 84.

Mailing Standards

Plans/Part D Sponsors must comply with the mailing standards of the United

States Postal Service contained in the Domestic Mail Manual.

Plain Writing Act of 2010

P.L. 111-274, 124 STAT. 2861 (October 13, 2010)

Plans/Part D Sponsors are required to write all Medicare publications, forms,

and publicly distributed documents in a clear, concise, and well-organized

manner.

Section 1557 of the Patient Protection and Affordable Care Act

Section 1557 is the nondiscrimination provision of the Affordable Care Act

(ACA). The law prohibits discrimination on the basis of race, color, national

origin, sex, age, or disability in certain health programs or activities. Section

1557 builds on long-standing and familiar Federal civil rights laws: Title VI of

the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972,

Section 504 of the Rehabilitation Act of 1973 and the Age Discrimination Act

of 1975. Section 1557 extends nondiscrimination protections to individuals

participating in:

• Any health program or activity any part of which received funding from

HHS

• Any health program or activity that HHS itself administers

• Health Insurance Marketplaces and all plans offered by issuers that

participate in those Marketplaces.

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Appendix 3 – Pharmacy Technical Help/Coverage Determinations and

Appeals Call Center Requirements

Pharmacy Technical Help Call Center Requirements

42 CFR 423.128(d)(1)

Part D Sponsors must operate a toll-free pharmacy technical help call center

or make available call support to respond to inquiries from pharmacies and

providers regarding the beneficiary’s Medicare prescription drug benefit;

inquiries may pertain to operational areas such as claims processing, benefit

coverage, claims submission, and claims payment. This requirement can be

accommodated through the use of on-call staff pharmacists or by contracting

with the organization’s PBM during non-business hours as long as the

individual answering the call is able to address the call at that time. The call

center must operate or be available during usual business hours, which CMS

interprets to mean during the entire period in which the Part D Sponsor’s

network pharmacies in its plans’ service areas are open (e.g., Part D

Sponsors whose pharmacy networks include twenty-four (24) hour

pharmacies must operate their pharmacy technical help call centers twenty-

four (24) hours a day as well).

To be considered fully compliant with the regulatory requirement to meet

standard customer service business practices, the pharmacy technical help

call center operates within the following standards:

• Average hold time not to exceed two (2) minutes (the average hold

time is defined as the time spent on hold by the caller following the

interactive voice response (IVR) system, touch-tone response system,

or recorded greeting and before reaching a live person);

• Eighty (80) percent of incoming calls answered within thirty (30)

seconds; and

• Disconnect rate of all incoming calls not to exceed five (5) percent.

Part D Sponsor Coverage Determinations and Appeals Call Center

Requirements

423.128(b)(7), 423.128(d)(1)(iv), 423.566(a)

All Part D Sponsors must operate a toll-free call center with live customer

service representatives available to respond to providers or enrollees for

information related to coverage determinations, including exceptions, prior

authorizations, and appeals. Part D Sponsors are required to provide

immediate access to the coverage determination and redetermination

processes via their toll-free call centers. The call centers must operate

during normal business hours, which CMS interprets to mean from at least

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8:00 a.m. to 8:00 p.m., Monday through Friday; in the time zones for the

regions in which they operate. Part D Sponsors are expected to accept

requests for coverage determinations/redeterminations outside of normal

business hours, but are not required to have live customer service

representatives available to accept such requests outside normal business

hours. Additional details are available in Chapter 18 of the Medicare

Prescription Drug Benefit Manual.

Voicemail may be used outside of normal business hours and the voice mail

message should:

• Indicate that the mailbox is secure;

• List the information that must be provided so the case can be worked,

(e.g., provider identification, beneficiary identification, type of request

(coverage determination or appeal), physician support for an exception

request, and whether the enrollee is making an expedited or standard

request);

• For coverage determination calls (including exceptions requests),

articulate and follow a process for resolution within twenty-four (24)

hours of call for expedited requests and seventy-two (72) hours for

standard requests; and

• For appeals calls, information should articulate the process information

needed and provide for a resolution within seventy-two (72) hours for

expedited appeal requests and seven (7) calendar days for standard

appeal requests.