Department of Health and Human Services
 

OFFICE OF 

INSPECTOR GENERAL 

MARKETING MATERIALS FOR 


MEDICARE PRESCRIPTION 


DRUG PLANS
 

Daniel R. Levinson
 

Inspector General 


September 2008
 

OEI-01-06-00050
 
 

 

 

 

 

 

Office of Inspector General
 http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components: 

Office of Audit Services 

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits 

examine the performance of HHS programs and/or its grantees and contractors in carrying 

out their respective responsibilities and are intended to provide independent assessments of 

HHS programs and operations. These assessments help reduce waste, abuse, and 

mismanagement and promote economy and efficiency throughout HHS. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on significant 

issues. These evaluations focus on preventing fraud, waste, or abuse and promoting 

economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI 

reports also present practical recommendations for improving program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 

of fraud and misconduct related to HHS programs, operations, and beneficiaries. With 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

by actively coordinating with the Department of Justice and other Federal, State, and local 

law enforcement authorities. The investigative efforts of OI often lead to criminal 

convictions, administrative sanctions, and/or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support for OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

also negotiates and monitors corporate integrity agreements. OCIG renders advisory 

opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities. 
 

 

Δ EXECUTIVE SUMMARY 

OBJECTIVES 

1. To assess the Centers for Medicare & Medicaid Services’ (CMS) 

oversight of marketing materials for stand-alone Medicare prescription 

drug plans (PDP). 

2. To determine the extent to which marketing materials for PDPs meet 

CMS guidelines. 

BACKGROUND 

The Medicare Prescription Drug, Improvement, and Modernization Act 

of 2003 added voluntary outpatient prescription drug coverage to 

Medicare. Private health insurance organizations (hereafter referred to 

as sponsors) contract with CMS to offer PDPs. Sponsors distribute 

marketing materials, which CMS defines as materials that promote a 

PDP; provide enrollment information; or explain its benefits, rules, and 

covered services. Marketing materials include advertisements, 

comprehensive formularies, enrollment forms, pharmacy directories, 

and summaries of benefits. 

CMS’s Medicare Marketing Guidelines (hereafter referred to as the 

guidelines) specify what marketing materials must include when 

describing PDP coverage. To help ensure accuracy and expedite the 

review process for certain marketing materials, CMS created model 

documents, which are uniform texts that contain pertinent information. 

CMS also requires PDP sponsors to use standardized language for the 

summary of benefits. Before PDP sponsors distribute marketing 

materials, they must submit them to CMS under one of two review 

processes. Under the standard review process, CMS staff manually 

review marketing materials. Under the file & use process, CMS staff do 

not review materials; rather, PDP sponsors attest that the marketing 

materials comply with CMS guidelines. The guidelines also outline 

other oversight activities for CMS to monitor marketing materials, such 

as requiring identification numbers on materials. 

We assessed CMS’s oversight of PDP materials based on the oversight 

strategies outlined in its guidelines. We used CMS’s guidelines, 

regulations, responses to oral and written questions, and data from 

CMS’s Health Plan Management System (HPMS) to assess its oversight 

of the materials. To determine whether marketing materials met 

CMS’s guidelines, we reviewed marketing materials from a stratified 

simple random sample of 115 PDPs offered in 2007. All estimates in our 

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E X E CUTIV E SUMMARY SUMMARY 

report are projectable to the population of PDPs for each type of 

material. We also reviewed model documents using these same review 

guides. 

FINDINGS 

CMS’s oversight for PDP marketing materials is limited. CMS promotes 

its file & use process but did not complete a retrospective review of the 

2006 file & use marketing materials until April 2008. Although CMS 

completed standard reviews of marketing materials on a timely basis, the 

reviews lack consistency across regions. None of the performance audits 

that CMS had conducted at the time of our review examined elements 

pertaining to marketing materials. We were unable to determine whether 

CMS has conducted marketplace reviews. Additionally, identification 

numbers from 45 percent of the materials we reviewed failed to match the 

numbers in the HPMS. Because the identification numbers do not 

uniformly identify which materials are written in non-English languages 

or alternative formats, CMS lacks a systematic way to track them. 

CMS’s model documents are not consistent with its guidelines, 

resulting in problems with PDP marketing materials. The 

standardized language for summaries of benefits omits aspects of 

required information on the low income subsidy; accordingly, nearly all 

summaries of benefits lack this information. The model enrollment 

form also lacks key information required by the guidelines. 

Consequently, almost all enrollment forms fail to include this key 

information. Most enrollment forms also lack the required statement on 

the availability of the form in alternative formats, which is also missing 

on the model enrollment form. In addition, many marketing materials 

lack hours of operation and phone numbers for deaf persons (TTY/TDD) 

where model documents omit these elements. Lastly, the guidelines 

and model documents do not match in other aspects. 

Overall, PDP marketing materials did not meet CMS guidelines. 

Eighty-five percent of marketing materials failed to meet at least one 

element of CMS’s guidelines. These elements reflected the array of 

requirements in the guidelines, which ranged from details about PDP 

benefits and rules to requirements for font size for footnotes. In 

addition to problems with marketing materials that stem from model 

documents, 79 percent of advertisements with pharmacy cobranding 

failed to include a required statement that other pharmacies are also 

available. Forty-two percent of pharmacy directories did not describe 

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EXECUTIVE SUMMARY 

the process for a beneficiary to obtain a prescription if mail order service 

is delayed, as required. Seventeen percent of comprehensive 

formularies, which are organized by therapeutic class, failed to include 

an alphabetical index of drugs, as required, potentially hindering 

beneficiaries’ ability to find information about their drugs. 

RECOMMENDATIONS 

To improve CMS oversight and ensure that PDPs provide accurate 

marketing materials, we recommend that CMS: 

Revise model documents to ensure consistency between model 

documents and guidelines. By ensuring that the model materials and 

the standardized language for summaries of benefits follow CMS 

guidelines, CMS would provide more accurate guidance to plans and 

ultimately beneficiaries. 

Develop protocols for the review of marketing materials. These 

protocols would assist CMS’s reviewers in ensuring that marketing 

materials include all required elements. 

Conduct and complete more frequent retrospective reviews of 

file & use materials to monitor these materials. Performing 

retrospective reviews on a more frequent basis would provide CMS with 

more timely information to ensure that file & use materials meet the 

guidelines. 

Enforce the use of the current tracking system and enhance it to 

include an identifier for marketing materials written in non-English 

languages and alternative formats. These steps would increase CMS’s 

ability to track specific materials, which would help CMS oversee them 

and respond to complaints about them. 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS concurred with all four of our recommendations. In its comments, 

CMS noted that it had implemented steps to improve its oversight of 

marketing materials and identified seven areas for improving the 

review process for marketing materials. 

CMS also noted that it had made corrections to its model enrollment 

form in June 2007 and had completed its first retrospective review of 

file & use materials. We amended the report to indicate that CMS had 

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EXECUTIVE SUMMARY 

completed these tasks but that both were outside the period of our 

review. 

In addition, CMS noted that it focuses its review of marketing materials 

on elements it considers most critical to beneficiary understanding, and 

not on all elements contained in the guidelines. However, CMS’s 

guidelines do not distinguish between critical and noncritical elements. 

Therefore, we reviewed marketing materials based on the requirements 

for each type of material detailed in CMS’s marketing and enrollment 

guidelines. 

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Δ TABLE OF CONTENTS 

EXECUTIVE SUMMARY ..................................... i 
 

INTRODUCTION ........................................... 1 
 

FINDINGS ................................................. 9 
 

CMS’s oversight is limited ................................ 9 
 

CMS’s model documents are not consistent with guidelines..... 12 
 

PDP marketing materials did not consistently meet guidelines. . 17 

RECOMMENDATIONS ..................................... 20 
 

Agency Comments and Office of Inspector General Response . . . 21 

APPENDIXES ............................................. 23 
 

A: Methodology ....................................... 23 
 

B: Estimates and Confidence Intervals..................... 26 
 

C: Number of Elements Not Meeting CMS’s Guidelines in 

Each Type of Marketing Material ...................... 29 
 

D: Agency Comments................................... 31 
 

ACKNOWLEDGMENTS .................................... 36 
 
 

BANNER 2ND PAGE 

 

 

Δ INTRODUCTION 

OBJECTIVES 

1. To assess the Centers for Medicare & Medicaid Services’ (CMS) 

oversight of marketing materials for stand-alone Medicare prescription 

drug plans (PDP). 

2. To determine the extent to which marketing materials for PDPs meet 

CMS guidelines. 

BACKGROUND 

Medicare Prescription Drug Plans 

The Medicare Prescription Drug, Improvement, and Modernization Act 

of 2003 (P.L. No. 108-173) added voluntary outpatient prescription drug 

coverage to Medicare, known as Medicare Part D. Private health 

insurance organizations (hereafter referred to as sponsors) contract with 

CMS to offer Part D benefits. Beneficiaries may obtain prescription 

drug coverage through PDPs or Medicare Advantage-prescription drug 

plans (MA-PD) that offer integrated coverage for both prescription 

drugs and other health care. This evaluation focuses on PDPs only. 

PDP Marketing Materials 

CMS defines marketing materials as informational materials that 

promote a PDP, provide enrollment information, explain its benefits, 

describe its rules, explain how services are covered, or communicate 

with an individual regarding various membership policies, procedures, 

and rules.1 Regulations require that materials provide beneficiaries 

with an “[a]dequate written description of rules (including any 

limitations on the providers from whom services can be obtained), 

procedures, basic benefits and services, and fees and other charges” and 

“[a]ny other information necessary to enable beneficiaries to make an 

informed decision about enrollment.”2 (See Table 1 on page 2 for a 

description of the selected marketing materials reviewed in this 

evaluation.) 

1 42 CFR § 423.50(b). 

2 42 CFR §§ 423.50(d)(1)(i) & (iii).
 

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INTRODUCTION 
 

TABLE 1 

Description of 

Types of PDP 

Marketing 

Materials Reviewed 

in This Evaluation 

Type of Material Purpose 

Advertisements Used to attract potential enrollees. Includes materials such as 

newspaper advertisements, marketing posters, and fliers 

Summary of Benefits Provides general information on PDP guidelines and benefits 

Comprehensive Formulary Conveys details about covered drugs and the level of coverage 

Enrollment Form Used by beneficiaries to enroll in PDPs 

Pharmacy Directory Lists pharmacies where enrollees can have their prescriptions 

filled 

Source: CMS Medicare Marketing Guidelines, 2007. 

Guidelines for PDP Marketing Materials 

The Medicare Marketing Guidelines (hereafter referred to as the 

Medicare Marketing Guidelines or guidelines) represent “CMS’s 

current, official position on marketing policy and operational 

instructions” for PDPs.3 The guidelines include sections on marketing 

material content, including disclaimers and formatting requirements. 

They also outline the process for CMS’s review of marketing materials. 

The guidelines specify the language, definitions, and explanations that 

marketing materials must include when describing plan coverage. 

Materials must include some of these elements verbatim. Among these, 

the guidelines detail specific information for preenrollment and 

postenrollment materials. Preenrollment materials refer to marketing 

materials used by beneficiaries before enrolling in a PDP, and 

postenrollment materials refer to marketing materials that provide 

information to beneficiaries enrolled in a PDP. 

Furthermore, CMS includes additional guidelines for enrollment forms 

in “PDP Guidance—Eligibility, Enrollment, and Disenrollment” 

(hereafter referred to as Enrollment Guidelines). The Enrollment 

Guidelines include statements that the beneficiary consents to upon 

enrolling in the PDP.4 The Enrollment Guidelines also provide a list of 

3 CMS, “Medicare Marketing Guidelines for: Medicare Advantage Plans, Medicare 

Advantage Prescription Drug Plans, Prescription Drug Plans, and 1876 Cost Plans” 

(2nd Revision: July 25, 2006), (hereafter referred to as “Medicare Marketing Guidelines”), 

p. 1. 

4 CMS, “PDP Guidance—Eligibility, Enrollment, and Disenrollment” (hereafter referred 

to as “Enrollment Guidelines”), section 30.1. In June 2007, CMS issued a revised version of 

the Enrollment Guidelines. We reference the version that was available in March 2007 

because we used this iteration during our review. 

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INTRODUCTION 

data elements that must be collected to complete the beneficiary’s 

enrollment into the PDP. 

Model Marketing Materials 

To help ensure accuracy and expedite the review process for certain 

marketing materials, CMS created model documents, which are uniform 

texts that contain pertinent information. To qualify for an expedited 

review, sponsors may modify the model document only with specifics 

about the individual PDP’s benefits and plan information. CMS offers 

models for the enrollment form, comprehensive formulary, and 

pharmacy directory, among other types of marketing materials. CMS 

does not offer models for advertisements. 

In addition to offering model documents, CMS requires PDP sponsors to 

use standardized language for the summary of benefits (hereafter 

referred to as the standardized SB).5 Sponsors can automatically 

generate a standardized SB for their PDPs through CMS’s Health Plan 

Management System (HPMS). The HPMS combines boilerplate 

language with specific information from a PDP’s plan benefit package to 

create an individual summary of benefits. 

In this report, we use the term “model documents” to refer to the 

available model materials and the standardized SB. We will refer to 

each individual document specifically when needed throughout the 

report. 

CMS Oversight for Marketing Materials: Review Processes 

CMS has two types of review processes, described below. The type of 

review process for a material depends on the type of material and 

whether the material uses unmodified model documents (see Figure 1 

on page 5). 

Standard Review. Under the standard review process, CMS regional 

office staff manually review PDP marketing materials. The standard 

review period may be either 10 days or 45 days: 

•	 10-day standard review period. Sponsors may submit marketing 

materials for the 10-day review period if the sponsor uses CMS’s 

model documents and does not modify the language or sequence 

5 CMS, “Medicare Marketing Guidelines,” pp. 15 and 35. 

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INTROD U C T I O N 

used in the model documents (other than specifics about the 

individual PDP’s benefits and plan information).6 

• 45-day standard review period. Sponsors must use this period for 

marketing materials if they modify the language used in model 

documents or if they do not use model documents for materials.7 

After the 10- or 45-day period has passed, a sponsor may distribute the 

material unless CMS notifies the sponsor that it has disapproved the 

material.8 Marketing materials that CMS has neither approved nor 

disapproved by the close of the review period are deemed approved.9 

File & Use. CMS’s file & use certification system (hereafter, referred to 

as file & use) streamlines the process for PDP sponsors to submit and 

distribute certain types of materials.10 Eligible materials include all 

forms of advertising, pharmacy directories, and formularies, among 

others.11 To submit materials as file & use, PDP sponsors may modify 

the model document only with specifics about the individual PDP’s 

benefits and plan information. Sponsors must attest, when submitting 

materials, that they comply with the guidelines.12 Under file & use, 

PDP sponsors must submit materials to CMS 5 days before 

disseminating them. CMS regional office staff do not review file & use 

materials at the time of submission. Rather, CMS reviews the 

materials retrospectively. 

CMS strongly encourages PDP sponsors to use file & use for qualified 

materials.13 PDP sponsors may choose to have CMS review marketing 

materials under the standard review process. However, CMS requires 

6 CMS, “Medicare Marketing Guidelines,” p. 97. 

7 CMS, “Medicare Marketing Guidelines,” p. 96. 

8 Ibid. 

9 Ibid. 

10 CMS also offers an additional review process called file & use eligibility, which further 

streamlines the review of marketing materials. To qualify for this process, PDP sponsors 

“must have submitted at least eighteen months of reviewable marketing materials,” among 

other criteria. Because Part D had been in existence for fewer than 18 months at the time 

that we initiated this evaluation, no PDP sponsor was qualified for this process. See CMS, 

“Medicare Marketing Guidelines,” p. 103. 

11 PDP sponsors may provide beneficiaries with either abridged or comprehensive 

formularies. See CMS, “Medicare Marketing Guidelines,” p. 59. 

12 CMS, “Medicare Marketing Guidelines,” pp. 100–101. 

13 CMS, “Medicare Marketing Guidelines,” p. 98. 

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INTRODUCTION 

PDP sponsors to use file & use for at least 90 percent of materials that 

qualify for this process.14 

FIGURE 1 

Flow Chart of the 

Review Process 

for Selected PDP 

Marketing 

Materials 

* Model documents are not offered for advertisements. 

Can be submitted as 

file & use 5 days prior 

to distribution 

No 

45-day 

standard 

review 

Yes 

Can be submitted as 

file & use 5 days prior 

to distribution or 10-day 

standard review 

Yes 

10-day 

standard 

review 

Type of marketing material 

Use unmodified model 

documents? 

Use unmodified model 

documents? 

Enrollment form, 

Summary of benefits 

Pharmacy directory, 

Comprehensive formulary 

Advertisements* 

Source: Office of Inspector General analysis of the PDP marketing material review process, 2007. 

CMS Oversight for Marketing Materials: Additional Activities 

The guidelines outline additional oversight activities used by CMS to 

monitor marketing materials. These activities include: 

Retrospective review. CMS oversees file & use materials through 

retrospective reviews, which may be conducted semiannually.15
 

Marketplace review. CMS may review marketing materials under three 

circumstances: use by or in the media; as part of complaint 

investigations; and during scheduled onsite visits to sponsors for 

contract compliance monitoring.16 

Audits. CMS conducts periodic compliance audits of sponsors’ 

operations. CMS’s “PDP Sponsor Audit Guide Version 1.0,”
 

April 10, 2006 (hereafter referred to as the PDP Sponsor Audit Guide) 

details the elements that may be covered in the audits. Six elements 

14 CMS, “Medicare Marketing Guidelines,” p. 99. 

15 CMS, “Medicare Marketing Guidelines,” pp. 98–99. 

16 CMS, “Medicare Marketing Guidelines,” p. 109. 

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INTRODUCTION 

within the “Marketing and Beneficiary Information” chapter pertain to 

marketing materials.17 

Oversight of materials in other languages and alternative formats. 

Sponsors that offer marketing materials in non-English languages and 

alternative formats (such as Braille) must base them on approved 

marketing materials written in English.18 After CMS approves the 

English version of a marketing material, sponsors submit the 

non-English or alternative format material to CMS along with a letter 

attesting that the material includes the same content as the English 

version.19 

To oversee materials in non-English languages and alternative formats, 

CMS conducts a verification review of the materials and also reviews 

these materials on an “as needed basis.”20 

Marketing Material Identification System. CMS requires plan sponsors to 

include a unique identification number (hereafter referred to as 

material ID) on each piece of marketing material.21 The material ID 

includes the sponsor’s contract number, a series of digits of the sponsor’s 

choosing, and the date of its approval, if applicable.22 The material ID 

enables CMS to track each piece of marketing material in the 

marketplace and in the HPMS. 

Previous Office of Inspector General Work on Medicare Marketing Materials 

In 2000, we found that few approved marketing materials for Medicare 

+ Choice plans were in full compliance with the guidelines and almost 

half of the materials were not consumer friendly.23 We recommended 

that CMS update the marketing guidelines, provide accurate model 

17 CMS, “PDP Sponsor Audit Guide,” Chapter 3. These elements, MR01, 02, 03, 07, 08, 

and 10, pertain to submission and distribution of marketing materials, file & use marketing 

materials, requirements for preenrollment materials, marketing materials for significant 

non-English-speaking populations, marketing to people with disabilities, and requirements 

for postenrollment materials. 

18 CMS, “Medicare Marketing Guidelines,” p. 115. 

19 Ibid. 

20 CMS, “Medicare Marketing Guidelines,” p. 93. 

21 CMS, “Medicare Marketing Guidelines,” p. 107. 

22 CMS does not require an approval date for file & use materials. See CMS, “Medicare 

Marketing Guidelines,” p. 108. 

23 Department of Health and Human Services (HHS), Office of the Inspector General 

(OIG), “Medicare Managed Care—1998 Marketing Materials,” OEI-03-98-00271, 

February 2000. Medicare + Choice was the previous name for Medicare Advantage plans. 

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INTRODUCTION 

documents, develop protocols for CMS staff to use when reviewing 

marketing materials, and track reviews consistently across regions. 

In 2005, we found that 39 of 62 marketing materials for the temporary 

Medicare drug discount card lacked required information.24 Missing 

information concerned eligibility, program disclaimers, choice of cards, 

and comparative drug card information. 

In 2006, we found that although marketing materials for Medicare 

Advantage (MA) plans generally met CMS requirements, materials 

lacked some required information.25 The missing information included 

CMS requirements concerning limitations to prescription drug benefits, 

most notably language concerning prescription drug formularies. 

 OEI-01-06-00050 

METHODOLOGY 

Scope 

We assessed CMS’s oversight of PDP materials based on the oversight 

strategies outlined in its guidelines. We also determined whether five 

types of marketing materials from a sample of PDPs offered in calendar 

year 2007 met CMS’s guidelines. These materials include selected 

advertising materials (newspaper advertisements, marketing posters, 

and fliers), summaries of benefits, comprehensive formularies, 

enrollment forms, and pharmacy directories. These represent materials 

that would be used by beneficiaries prior to and after enrolling in a 

PDP. 

Data Sources and Analysis 

Our evaluation relied on four sources: CMS marketing guidelines, 

Enrollment Guidelines, and regulations; information from CMS 

officials; data from the HPMS; and 2007 PDP marketing materials. We 

used CMS’s guidelines, regulations, responses to oral and written 

questions, and data from the HPMS to assess its oversight of the 

materials. We also used the HPMS data to assess timeframes for 

marketing material reviews and material ID numbers. 

24 HHS, OIG, “Assessment of Sponsors’ Materials Under the Temporary MedicareApproved Drug Discount Card Program,” OEI-05-04-00190, October 2005. The temporary 

Medicare-Approved drug discount card program provided Medicare beneficiaries with 

access to discounted prescription drugs from June 2004–December 2005 while CMS 

implemented Medicare Part D. 

25 HHS, OIG, “Medicare Advantage Marketing Materials for Calendar Year 2005,” 

OEI-01-05-00130, August 2006. 

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INTROD U C T U C T I O N I O N 

To determine whether marketing materials met CMS’s guidelines, we 

reviewed materials from a stratified simple random sample of 

115 PDPs. All estimates in our report are projectable to the population 

of PDPs for each type of material. We created and used review guides 

based on CMS marketing guidelines and regulations. The review guides 

divided CMS’s guidelines into separate elements for each material. The 

number of elements in each review guide varied by type of material 

because the number of specific guidelines varied for each material. We 

also reviewed model documents using these same review guides. 

Lastly, we received training in March 2007 from staff in CMS’s New 

York regional office. This training covered an overview of the 

marketing guidelines, guidelines for specific types of marketing 

materials, and the region’s process for reviewing marketing materials. 

For a detailed methodology, see Appendix A. 

Limitations 

This study did not assess CMS’s oversight of marketing practices, such 

as tactics used by insurance brokers when enrolling beneficiaries in 

PDPs and MA plans. Nor did it review the oversight or marketing 

materials for Special Needs Plans or MA-PDs. We did not assess all 

requirements in the guidelines because some requirements, such as 

Internet marketing, were outside the scope of the study. Furthermore, 

we did not analyze certain elements because we were unable to clearly 

interpret the guidelines for these elements. 

Standards 

This study was conducted in accordance with the “Quality Standards for 

Inspections” issued by the President’s Council on Integrity and 

Efficiency and the Executive Council on Integrity and Efficiency. 

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Δ FINDINGS 

CMS’s oversight for PDP marketing materials is CMS’s guidelines outline numerous 

limited strategies to oversee marketing 

materials. These include model 

documents, retrospective reviews of file & use materials, marketplace 

reviews, audits, use of material ID numbers, and reviews of materials in 

alternative formats or non-English languages. 

CMS promotes file & use but has yet to complete a retrospective review of 

file & use marketing materials 

Sponsors “are strongly encouraged to use file & use for all marketing 

materials qualified under this process.”26 Indeed, of the materials that 

sponsors used for calendar year 2007, 53 percent were submitted under 

file & use.27 

However, at the time of our review, CMS had not yet completed a 

retrospective review to determine whether any file & use materials 

followed the guidelines. In early 2007, CMS began such a retrospective 

review for file & use marketing materials used in 2006 by both PDPs 

and MA plans. CMS did not complete this review until April 2008.28 

CMS may terminate a sponsor’s file & use privileges if it determines 

that the file & use materials do not meet the guidelines.29 Because CMS 

did not complete its first retrospective review until April 2008, it was 

unable to determine whether any sponsors should have their file & use 

privileges revoked until more than 2 years after Medicare Part D began. 

CMS completed standard reviews of marketing materials on a timely basis 

but those reviews lack consistency across regions 

Under CMS’s standard review process, CMS regional office staff must 

review marketing materials within either a 10-day or 45-day timeframe, 

depending on the material. Reviewers met these timeframes 96 percent 

of the time for 10-day reviews and 99.7 percent of the time for 45-day 

26 CMS, “Medicare Marketing Guidelines,” p. 98. 

27 OIG analysis of CMS data from PDP marketing material reviews downloaded from the 

HPMS on November 14, 2007. This figure refers to all types of marketing materials 

submitted to CMS for PDPs offered in calendar year 2007. The percentage of materials 

submitted as file & use is based on the number of marketing materials with a status of 

accepted, approved, deemed, or populated template. This percentage excludes disapproved, 

pending, or withdrawn materials. 

28 CMS provided OIG with the results of the 2006 retrospective review, dated April 2008, 

in May 2008. 

29 CMS, “Medicare Marketing Guidelines,” p. 100. 

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FINDINGS 

reviews.30 Of the 11,791 materials reviewed, just 47 were not reviewed 

in the appropriate timeframes and were deemed approved.31 

Although CMS reviews almost all PDP marketing materials submitted 

for standard review within the established timeframes, CMS has not 

reviewed materials consistently. In 2000, an OIG report recommended 

that CMS use protocols for reviewing marketing materials.32 However, 

CMS still lacks standardized protocols for reviewers to follow, even 

though its staff in nine regional offices review PDP marketing 

materials. A study completed by a CMS contractor in January 2008 

found inconsistencies in the reviews of marketing materials from 2006 

and recommended that CMS use protocols to ensure consistent and 

efficient reviews of marketing materials.33 

CMS has rarely used audits and marketplace reviews to oversee marketing 

materials 

None of the performance audits that CMS had conducted at the time of 

our review included audit elements pertaining to marketing materials. 

When CMS schedules the audits, it selects the chapters from the PDP 

Sponsor Audit Guide that it will cover. As of September 2007, CMS had 

conducted 11 audits that reviewed elements from the chapter on 

Marketing and Beneficiary Information. These audits covered only 

those elements concerning sales brokers and notifying beneficiaries of 

formulary changes, but not elements concerning marketing materials.34 

In addition, even though CMS describes three different types of 

marketplace reviews in its guidelines, we were unable to determine how 

many of these reviews it had conducted based on information that CMS 

officials provided.35 According to CMS officials, the guidelines included 

30 OIG analysis of CMS data from PDP marketing material reviews downloaded from 

HPMS on November 14, 2007. 

31 OIG analysis of CMS data from PDP marketing material reviews downloaded from 

HPMS on November 14, 2007. This figure refers to all types of marketing materials 

submitted to CMS for PDPs offered in calendar year 2007. Numbers do not include pending 

or withdrawn materials. 

32 HHS, OIG, “Medicare Managed Care—1998 Marketing Materials,” OEI-03-98-00271, 

February 2000. 

33 CMS, internal study, January 31, 2008. 

34 Audits covered three elements: MR05 - No Engagement in Activities that Mislead, 

Confuse, or Misrepresent, MR06 - Plan Responsibility for Persons Employed or Contracted 

to Perform Marketing, MR09 - Provision of Notices Regarding Formulary Changes. Source: 

Data from audits provided by CMS, September 2007. 

35 CMS, “Medicare Marketing Guidelines,” p. 109. 

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FINDINGS 

marketplace reviews to show the breadth of options available to oversee 

marketing materials. However, CMS has yet to implement these 

options. For example, CMS officials told us that it has not conducted 

any onsite reviews because “to date there has been no need to do it.”36 

Additionally, CMS officials could not identify any instances in which 

they reviewed marketing materials as a part of complaint 

investigations. 

Even though CMS did not use audits and marketplace reviews to 

oversee marketing materials, CMS views reports from sponsors that 

monitor the materials of competing PDPs as an effective method of 

oversight. CMS officials informed us that monitoring by sponsors helps 

them to oversee file & use materials, such as advertisements, and told 

us that “follow through on these complaints [from sponsors] has enabled 

CMS to further reinforce [its] guidance.”37 However, CMS officials could 

not provide us with the number or type of complaints received from 

sponsors monitoring each other. 

The tracking system for marketing materials has shortcomings 

The guidelines require all marketing materials to include a material ID 

and state that it “must be entered into HPMS in the same manner that 

it appears on the material.”38 CMS uses this unique number to track 

the material and to locate it in the HPMS. CMS officials told us that 

the material ID enables beneficiaries to identify materials when they 

have complaints or questions. If CMS is unable to locate the material 

based on its material ID, it cannot easily access the material for 

oversight purposes. 

Material IDs from 45 percent of the materials we reviewed failed to 

match material IDs in the HPMS. If the material ID number present on 

the material does not match the material ID number in the HPMS, 

CMS cannot readily locate the material. In addition, 21 percent of all 

material IDs did not follow the proper format (see Table 2 on page 12; 

also see Appendix B for point estimates and confidence intervals). 

36 CMS, written response to OIG’s request for information on oversight of PDP marketing 

materials, September 20, 2007. 

37 Ibid. 

38 CMS, “Medicare Marketing Guidelines,” p. 107. 

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Advertisements 42% 14% 

Comprehensive Formulary 53% 32% 

Enrollment Form 40% 18% 

Pharmacy Directory 48% 40% 

Summary of Benefits 51% 19% 

All materials 45% 21% 

F I NDING S 

Material Percentage of Material 

IDs That Did Not Match 

Material IDs in the HPMS 

TABLE 2 Percentage of Material

Percentage of 

Material IDs Not 

Matching the HPMS 

and Not Following 

Proper Format 

IDs That Did Not Follow 

Proper Format 

Source: OIG analysis of PDP marketing materials, 2007. 

Finally, the material ID system does not uniformly identify which 

materials are written in non-English languages or alternative formats. 

CMS does not specify how a plan should indicate a non-English 

language material or a material in an alternative format. According to 

CMS officials, some regional offices request that sponsors use a suffix on 

their material ID numbers to indicate that a material is written in 

Spanish. Except for these regional offices’ requests, CMS lacks a 

systematic way to track materials in non-English languages or 

alternative formats. 

Without a specific means to identify the materials, CMS is unable to 

readily identify materials available in non-English and alternative 

formats. Lacking the ability to easily identify these materials impedes 

CMS’s ability to monitor the content of the materials through a 

verification review. 

CMS’s model documents are not consistent CMS created model documents to 

with its guidelines, resulting in problems with streamline the process for PDP 

PDP marketing materials sponsors to create marketing 

materials and for CMS to review 

these materials. These model documents include models for the 

enrollment form, comprehensive formulary, and pharmacy directory, as 

well as the standardized SB. 

Low Income Subsidy information is less comprehensive than required 

Beneficiaries with limited income and assets are eligible to receive 

assistance to pay for the out-of-pocket costs associated with their Medicare 

Part D coverage through the Low Income Subsidy (LIS).39 The guidelines 

39 42 U.S.C. § 1395w-114. 

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FINDINGS 

require the summary of benefits to include specific information to help 

beneficiaries determine whether they qualify for the LIS. This 

information directs beneficiaries to 1-800-MEDICARE, the Social Security 

Administration (SSA), or their State Medicaid office.40 To qualify for the 

LIS based on income and assets, beneficiaries must apply through SSA or 

their State Medicaid office.41 

However, the standardized SB directs beneficiaries to 1-800-MEDICARE 

only (see Table 3). Consequently, 95 percent of summaries of benefits omit 

the language in the guidelines directing beneficiaries to SSA or their State 

Medicaid Office. A 2006 OIG study found that CMS had significant 

difficulties in identifying beneficiaries who qualify for the LIS.42 By 

omitting the two agencies that can determine whether beneficiaries 

qualify for the LIS based on income and assets, CMS misses an 

opportunity to convey this information to beneficiaries. 

TABLE 3 

 Comparison of 

CMS Marketing 

Guidelines and 

Standardized SB 

Language for LIS 

Required Language From CMS Marketing Language From CMS’s Standardized SB 

“If you qualify for extra help with your 

Medicare prescription drug plan costs, 

your premium and costs at the pharmacy 

will be lower. When you join [PDP name], 

Medicare will tell us how much extra help 

you are getting. Then we will let you know 

the amount you will pay. If you are not 

getting this extra help you can see if you 

qualify by calling 1-800-Medicare 

(1-800-633-4227). TTY/TTD users should 

call 1-877-486-2048.” 

Guidelines 

All Part D plan preenrollment marketing materials 

detailing eligibility requirements, monthly 

premiums and other member costs for Part D 

benefits must include the following language in 

paragraph or bullet form: 

“You may be able to get extra help to pay for your 

prescription drug premiums and costs. To see if 

you qualify for getting extra help, call: 

 1-800-MEDICARE (1-800-633-4227). 

TTY/TDD users should call 1-877-486-2048, 

24 hours a day/7days a week); 

 The Social Security Administration at 

1-800-772-1213 between 7 a.m. and 7 p.m., 

Monday through Friday. TTY/TDD users 

should call, 1-800-325-0778; or 

 Your State Medicaid Office” 

 OEI-01-06-00050 

Source: CMS Medicare Marketing Guidelines, p. 35, and standardized SB. 

40 CMS, “Medicare Marketing Guidelines,” p. 35. 

41 42 U.S.C. § 1395w-114(a)(3)(B). Beneficiaries who receive full Medicaid benefits, 

Supplemental Security Income benefits, or who are enrolled in a Medicare Savings Program 

automatically qualify for the Low Income Subsidy. See CMS, “Medicare & You 2008,” p. 76. 

42 HHS, OIG, “Identifying Beneficiaries Eligible for the Medicare Part D Low-Income 

Subsidy,” OEI-03-06-00120, November 2006. 

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FINDINGS 

Enrollment information lacks some required elements 

According to the Enrollment Guidelines, “[t]he PDP sponsor’s 

enrollment vehicle(s) must include information that the individual 

acknowledges” when enrolling in a PDP.43 These acknowledgments 

include agreeing to follow the rules of the PDP and acknowledging the 

PDP’s appeals process, among others.44 The absence of this information 

can result in beneficiaries being unaware of situations that could lead to 

a lack of coverage or enrollment in the wrong plan. 

However, the model enrollment form does not include all of the 

elements listed in the Enrollment Guidelines, which likely led to their 

absence in enrollment forms.45 Most notably, all of the enrollment 

forms lacked the required information explaining that if the beneficiary 

enrolls in more than one plan, the last form signed will be the plan to 

take effect.46 Further, 88 percent of enrollment forms for calendar year 

2007 did not explain that enrollment in a PDP automatically disenrolls 

the beneficiary from any other PDP, MA plan, or PACE plan in which 

the beneficiary is enrolled.47 48 Likewise, 88 percent of enrollment forms 

do not explain the expected effective date of enrollment in the PDP.49 

Additionally, the guidelines require all preenrollment materials to 

include a statement informing beneficiaries that the PDP contracts with 

the Federal Government.50 Yet, this statement is missing on the model 

enrollment form. Consequently, 69 percent of enrollment forms failed to 

include this statement. 

Alternative format statements are missing 

The guidelines require both the enrollment form and the summary of 

benefits to include a statement that the material is available in 

43 CMS, “Enrollment Guidelines,” section 30.1. 

44 Ibid. 

45 Because we were unable to match all material ID numbers from marketing materials 

to HPMS data, we cannot determine whether sponsors used CMS’s model to create their 

enrollment forms. 

46 CMS, “Enrollment Guidelines,” sections 20 and 30.1. 

47 CMS, “Enrollment Guidelines,” section 30.1. PACE stands for Program of All Inclusive 

Care for the Elderly, which provides both social and medical services for the elderly. 

48 In June 2007, CMS released a revised model enrollment form. The revised model now 

includes the statement “I can only be in one Medicare prescription drug plan at a time – if I 

am currently in a Medicare prescription drug plan, my enrollment in <PDP Name> will end 

that enrollment.” 

49 CMS, “Enrollment Guidelines,” section 30.1. 

50 CMS, “Medicare Marketing Guidelines,” p. 33.
 

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FINDINGS 

alternative formats, such as Braille or audio tape.51 However, the model 

enrollment form lacks this statement, as do 85 percent of enrollment 

forms. In contrast, the standardized SB includes a statement 

concerning the availability of alternative formats, and more than 

99 percent of summaries of benefits include the statement. 

Hours of operation and telephone numbers are missing 

Generally, the guidelines require that marketing materials include 

operating hours and TTY/TDD numbers where all phone numbers are 

present.52 These requirements apply to all PDP customer service 

numbers, as well as to 1-800-MEDICARE. Providing this contact 

information ensures that beneficiaries with hearing difficulties know 

how to obtain additional information that they may need. 

However, CMS’s model documents omit the hours of operation and 

TTY/TDD phone numbers.53 Our previous work also identified these 

same problems with MA marketing materials.54 Table 4 on page 16 

shows that the model enrollment form and the standardized SB did not 

include the hours of operation for 1-800-MEDICARE in each place 

where the material listed the number. As a result, 85 percent of 

enrollment forms for calendar year 2007 and 86 percent of summaries of 

benefits did not include the hours of operation in all places where 

1-800-MEDICARE is listed. 

Likewise, the model enrollment form failed to include the Medicare 

TTY/TDD number in each place where 1-800-MEDICARE is listed, and 

37 percent of enrollment forms lacked this number where required. On 

the other hand, the model comprehensive formulary included TTY/TDD 

numbers in conjunction with all other telephone numbers and less than 

1 percent of comprehensive formularies lacked those numbers. 

51 CMS, “Medicare Marketing Guidelines,” p. 92. 

52 TTY and TDD numbers are telecommunications devices for deaf persons. CMS does 

not require certain advertisements, such as outdoor advertising, to follow these 

requirements. See CMS, “Medicare Marketing Guidelines,” p. 21. 

53 In June 2007, CMS released a revised model enrollment form. The revised model now 

includes the hours of operation and TTY/TDD phone number for 1-800-MEDICARE. 

54 HHS, OIG, “Medicare Advantage Marketing Materials for Calendar Year 2005,” 

OEI-01-05-00130, August 2006. 

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FINDINGS 

TABLE 4 Guidelines Type of Material Included Percentage 

Comparison of 

Guidelines, 

Materials, and 

Required 

Information 

Missing 

From 

Marketing 

Materials 

in Model? 

Organizations must also list the 

hours of operation for 1-800-

MEDICARE anytime the organization 

lists the 1-800-MEDICARE number 

Enrollment Form 

Summary of Benefits 

Comprehensive 

Formulary 

No 

No 

Yes

85% 

86% 

 0% 

The Medicare TTY/TDD number 

must appear in conjunction with 

1-800-MEDICARE 

TTY/TDD numbers must appear in 

conjunction with all other phone 

numbers 

Enrollment Form 

Comprehensive 

Formulary 

No 

Yes 

37% 

< 1% 

Source: OIG review of PDP marketing materials, 2007. 

Guidelines and model documents do not match in other aspects 

The guidelines require that some preenrollment materials, such as 

summaries of benefits and enrollment forms, inform beneficiaries who 

have drug coverage through MA plans that they may not duplicate 

Medicare drug coverage with PDPs. Those beneficiaries would have to 

disenroll from their MA plan before enrolling in a PDP. As Table 5 on 

page 17 shows, the standardized SB language fails to explain this 

potential duplication in the same detail as the guidelines. 

In addition, the standardized SB language assumes that beneficiaries 

have already determined whether they qualify for the LIS, rather than 

informing them that they “may be able to get extra help to pay for 

[their] prescription drug premiums and costs” as required by the 

guidelines.55 (See Table 3 on page 13.) Accordingly, 98 percent of 

summaries of benefits lack that statement. As previously noted, a 2006 

OIG study found that CMS had significant difficulties in identifying 

beneficiaries who qualify for the LIS.56 By using the language in the 

standardized SB, CMS misses an opportunity to explicitly convey the 

availability of the LIS. 

55 CMS, “Medicare Marketing Guidelines,” pp. 34–35. 

56 HHS, OIG, “Identifying Beneficiaries Eligible for the Medicare Part D Low-Income 

Subsidy,” OEI-03-06-00120, November 2006. 

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FINDINGS 

TABLE 5 

Comparison of CMS 

Marketing 

Guidelines and 

Standardized SB 

Language for 

Enrollment 

Information 

Required Elements From CMS Marketing Language From CMS’s 

Standardized SB 

“Eligible individuals may only enroll 

in one Medicare Prescription Drug 

Plan at a time and may not be 

enrolled in a Medicare Advantage 

Plan (HMO, PPO), unless they are a 

member of Medicare Private-FeeFor Services plan or are enrolled in 

an 1876 Cost Plan.” 

Guidelines 

“If enrolled in an MA coordinated care (HMO or 

PPO) plan or an MA PFFS plan that includes 

Medicare prescription drugs, the enrollee may not 

enroll in a PDP unless they disenroll from the HMO, 

PPO or MA PFFS plan.” 

“Enrollees in a private fee-for-service plan (PFFS) 

that does not provide Medicare prescription drug 

coverage, or an MA Medical Savings Account 

(MSA) plan may enroll in a PDP. Enrollees in an 

1876 Cost plan may enroll in a PDP.” 

Source: CMS Medicare Marketing Guidelines, p. 37, and standardized SB. 

Overall, PDP marketing materials did not Most marketing materials did not 

consistently meet CMS guidelines meet all elements of CMS’s 

guidelines. The elements not met 

comprise the omissions from the model documents, as discussed above, 

as well as problems with the language created by sponsors. We 

identified an array of problems that reflect the range of requirements 

included in the guidelines. This range covers details about PDP 

benefits and rules to requirements for font size for footnotes. Below, we 

discuss the extent and nature of these problems. 

Most marketing materials did not follow the guidelines for one or more 

elements 

Overall, 85 percent of marketing materials failed to meet at least one 

element of the guidelines. This includes the aforementioned problems 

that stem from the model documents, as well as other problems that we 

found (see Table 6). 

TABLE 6 

Percentage of PDP 

Marketing 

Materials That Fail 

To Meet CMS 

Guidelines for One 

or More Elements 

Percentage of Materials Not Following CMS 

Guidelines for One or More Elements 

Material 

Enrollment Form 100% 

Summary of Benefits 100% 

Comprehensive Formulary 96% 

Pharmacy Directory 86% 

Advertisements 73% 

All materials 85% 

Source: OIG analysis of PDP marketing materials, 2007. 

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F I NDING S 

TABLE 7 

Average Number and 

Percentage of 

Elements of CMS 

Guidelines That PDP 

Marketing Materials 

Fail To Meet 

Enrollment forms and summaries of benefits had the highest average 

percentage of elements that did not meet the guidelines.57 On average, 

enrollment forms did not meet 10 of the 60 elements we reviewed, and 

summaries of benefits did not meet 9 of the 51 elements. CMS 

identifies these two materials, as well as other materials that do not 

qualify for file & use, as posing a greater risk to beneficiaries if they 

contain information “inaccurate in any way.”58 In contrast, 

comprehensive formularies, pharmacy directories, and advertisements 

had fewer problems, with an average of one or two elements that did not 

meet the guidelines (see Table 7; also see Appendix C for ranges of 

elements not met for each type of material). 

Material 

Elements Not 

Meeting CMS 

Guidelines 

Average Number of

Elements 

Reviewed for 

Each Type

 of Material 

of Elements Not 

Meeting CMS 

Guidelines 

Number of Average Percentage 

Enrollment Form 10 60 17% 

Summary of Benefits 9 51 18% 

Comprehensive Formulary 2 39 5% 

Pharmacy Directory 2 27 8% 

Advertisements 1 23 5% 

Source: OIG analysis of PDP marketing materials, 2007. 

Although all elements of the guidelines are important, some can have a 

greater impact on the accuracy of information disseminated to 

beneficiaries than others. For example, missing information about 

obtaining prescriptions at network pharmacies could affect beneficiaries 

more than footnote placement. Below, we describe three common 

problems found in PDP marketing materials. 

Cobranding requirements were often unmet 

CMS defines cobranding as a business relationship between the sponsor 

of a Medicare plan and another entity, such as a pharmacy.59 The 

guidelines require that when cobranding is present on a marketing 

material, it must note that other pharmacies are available in the 

57 Statistically significant at the 95-percent confidence level in a two-tailed multiple 

comparison test employing a Bonferroni adjustment. 

58 CMS, “Medicare Marketing Guidelines,” p. 99. 

59 CMS, “Medicare Marketing Guidelines,” p. 6. 

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FINDINGS 

sponsor’s network.60 Yet, 79 percent of advertisements with cobranding 

did not include this statement. Without this statement, beneficiaries 

might believe that they may use only those pharmacies whose logos are 

present on the marketing material. 

Processes for mail order delays are frequently missing 

The guidelines require that pharmacy directories describe the process 

for a beneficiary to obtain a prescription if the mail order service is 

delayed.61 However, 42 percent of pharmacy directories did not describe 

this process. Of these, 85 percent stated that the sponsor would call the 

beneficiaries in the case of a delay rather than informing them of a 

specific action they could take. This may hinder beneficiaries’ ability to 

obtain prescriptions on time. Additionally, when describing mail order 

services, 31 percent of pharmacy directories did not include a toll-free 

number and TTY/TDD number to call with questions as required by the 

guidelines.62 

Some indexes required by CMS are missing 

Comprehensive formularies must include an alphabetical index that 

directs the beneficiary to the page containing complete information for a 

drug. Yet, 17 percent of comprehensive formularies lacked an index. 

Because the comprehensive formulary organizes all covered drugs by 

therapeutic class (such as cardiovascular agents), an index may help 

beneficiaries find information about their drugs. Its omission could hinder 

beneficiaries’ ability to find the appropriate drug.63 

60 CMS, “Medicare Marketing Guidelines,” p. 12. 

61 CMS, “Medicare Marketing Guidelines,” p. 55. 

62 CMS, “Medicare Marketing Guidelines,” p. 56. 

63 CMS, “Medicare Marketing Guidelines,” pp. 60–61. 

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Δ RECOMMENDATIONS 

Despite establishing numerous strategies to oversee PDP marketing 

materials, CMS has conducted limited oversight for these materials. 

Failure to effectively oversee PDP marketing materials has likely 

contributed to the problems that we found with the materials. These 

problems occurred in specific areas, which corresponded largely with 

discrepancies between CMS’s model documents and its guidelines. 

Information inaccurately conveyed in or omitted from the materials may 

affect a beneficiary’s ability to make an informed decision about 

enrollment or to access resources, services, or drugs. We also found 

problems with language created by sponsors. 

We recognize that Part D is a new and complex program; however, CMS 

has had years of experience with the marketing materials for its 

managed care program. We identified similar problems with marketing 

materials for Medicare + Choice and MA plans in 2000 and 2006. 

To improve CMS oversight and ensure that PDPs provide accurate 

marketing materials, we recommend that CMS: 

Revise model documents to ensure consistency between its model 

documents and guidelines 

This reiterates our recommendation from 2000, when we called for CMS 

to provide accurate model documents to Medicare + Choice sponsors.64 

By ensuring that the model materials and the standardized SB follow 

its guidelines, CMS would provide more accurate guidance to plans and 

ultimately beneficiaries. Since the time of this review, CMS has made 

some progress toward this end. We recommend that it continue this 

effort. 

Develop protocols for the review of marketing materials 

Our 2000 report called for developing standard review instruments for 

Medicare managed care marketing materials, which CMS has not yet 

implemented.65 We continue to recommend that CMS create such 

protocols to use for the review of all marketing materials. These 

protocols would assist CMS’s reviewers in ensuring that marketing 

materials include all required elements, such as processes for 

beneficiaries to follow when using mail-order pharmacies. Additionally, 

64 HHS, OIG, “Medicare Managed Care—1998 Marketing Materials,” OEI-03-98-00271, 

February 2000. 

65 Ibid. 

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RECOMMENDATIONS 

these protocols could be included in the guidelines so that PDP sponsors 

may use them to ensure their materials include all required elements. 

Conduct and complete more frequent retrospective reviews of file & use 

materials to monitor these materials 

In the three cycles of marketing materials since the implementation of 

the Part D program, CMS had yet to complete quality monitoring 

activities for file & use materials as of April 1, 2008. Performing 

retrospective reviews on a more frequent basis (such as the every 

6-month timeframe outlined in the guidelines) would provide CMS with 

more timely information to ensure that file & use materials meet the 

guidelines. 

Enforce the use of the current tracking system and enhance it to include an 

identifier for marketing materials written in non-English languages and 

alternative formats 

These steps would increase CMS’s ability to track specific materials, which 

would help CMS oversee them and respond to complaints about them. 

CMS officials told us that the agency will consider developing a system to 

identify non-English materials. We recommend that the agency proceed 

with this effort. 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS concurred with all four of our recommendations. In its comments 

on the draft report, CMS noted that it had implemented steps to 

improve its oversight of marketing materials and identified seven areas 

for improving the review process for marketing materials. These areas 

include developing standardized review protocols, piloting a national 

retrospective review process, updating model documents to include all 

requirements from the guidelines, focusing reviews on marketing 

materials that are most critical to beneficiary understanding, 

developing checklists for PDP sponsors to use when creating marketing 

materials, developing electronic attestations of material accuracy, and 

enhancing HPMS. 

CMS also noted that it had made corrections to its model enrollment 

form in June 2007 and had completed its first retrospective review of 

file & use materials. We amended the report to indicate that CMS had 

completed these tasks but that both were outside the period of our 

review. 

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RECOMMENDATIONS 

In addition, CMS noted that it focuses its review of marketing materials 

on elements it considers most critical to beneficiary understanding, and 

not all elements contained in the guidelines. However, CMS’s 

guidelines do not distinguish between critical and noncritical elements. 

Therefore, we reviewed marketing materials based on the requirements 

for each type of material detailed in CMS’s marketing and enrollment 

guidelines. 

The complete text of CMS’s comments can be found in Appendix D. 

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Δ APPENDIX ~ A 

METHODOLOGY 

Scope 

We assessed the Centers for Medicare & Medicaid Services’ (CMS) 

oversight of Prescription Drug Plan (PDP) materials based on the 

oversight strategies outlined in its guidelines. We also determined 

whether five types of marketing materials from a sample of PDPs 

offered in calendar year 2007 met CMS’s guidelines. These materials 

included selected advertising materials (newspaper advertisements, 

marketing posters, and fliers), summaries of benefits, comprehensive 

formularies, enrollment forms, and pharmacy directories. These 

represent materials that would be used by beneficiaries prior to and 

after enrolling in a PDP. 

Data Sources and Analysis 

Our evaluation relied on four sources: CMS guidelines and regulations, 

information from CMS officials, data from the Health Plan Management 

System (HPMS), and 2007 PDP marketing materials. 

CMS Oversight of Marketing Materials 

We assessed CMS’s oversight of PDP marketing materials through its 

guidance, information from CMS officials, and data from the HPMS. 

CMS guidelines. We reviewed CMS documents that outline its oversight 

strategy for marketing materials. These documents included the 

marketing guidelines, as well as relevant memoranda and guidance CMS 

issued, the Enrollment Guidelines, and the “PDP Sponsor Audit Guide 

Version 1.0,” April 10, 2006. 

Information from CMS officials. To supplement the data analysis, we 

conducted structured interviews with CMS officials concerning the 

agency’s oversight activities to date. Additionally, in August 2007, we 

sent a written request to CMS officials regarding details on file & use 

retrospective reviews, marketplace reviews, audits, and non-English or 

alternative format materials. In this request, we asked for documents 

that provided specific details on oversight activities, including their 

dates, the PDP sponsors examined, and their outcomes. 

Data from the HPMS. We obtained data from the HPMS on reviews of 

marketing materials for calendar year 2007. We used SAS® to match 

the unique identification number (hereafter referred to as material ID) 

on the marketing materials we reviewed to the material IDs of 

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APP E N D I X ~ A 

marketing materials reviewed by CMS. We also used SAS® to assess 

timeframes for marketing material reviews. Additionally, we examined 

data from the HPMS concerning the scheduling of audits. 

Review of Marketing Materials 

Sample design. In calendar year 2007, sponsors offered 1,866 PDPs in 

the 50 States and the District of Columbia. After consulting with other 

components of the Office of Inspector General (OIG), we reduced the 

number of PDPs under consideration to 1,763. We stratified the PDPs 

into two strata based on the total number of PDPs offered by each 

sponsor. We selected 35 PDPs from the stratum of sponsors offering 

4 or fewer PDPs, and 80 from the stratum of sponsors offering more 

than 4 PDPs (see Table 8 for breakdown of strata). 

TABLE 8 

Strata 

Characteristics 

Stratum Definitions Number of 

Plans in 

Population 

Number of 

Sponsors 

in 

Population 

Number of 

Plans in 

Sample 

Number of 

Sponsors in 

Sample 

Plans from sponsors 

offering total of four 

plans or fewer 

92 40 35 25 

Plans from sponsors 

offering total of five 

or more plans 

1,671 25 80 20 

Total 1,763 65 115 45 

Source: OIG collection of PDP marketing materials, 2007. 

Marketing materials collection. In April 2007, we contacted the PDPs in 

our sample and requested the five types of marketing materials listed in 

the Scope section for each PDP offered in 2007. We received at least one 

type of marketing material from each of the 115 PDPs in our sample 

(see Table 9 on page 24). Some sponsors sent multiple materials for a 

PDP, and we included all of the materials in our review. Each type of 

material had a different response rate and sample size. We estimated 

proportions for various characteristics of the materials. We expressed 

these proportions as percentages and projected them to the population 

of materials for all plans with an expected absolute precision no greater 

than 10 percent at the 95-percent confidence level assuming a 

90-percent plan response rate. 

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APPENDIX ~ A 

TABLE 9 

Response Rates 

and Total Number 

of Materials in 

Sample 

Type of Material Number of PDPs 

That Responded 

115 

112 

115 

113 

71 

Response 

Rate 

100% 

97% 

100% 

100%* 

84%** 

Sample Size of 

Materials 

122 

144 

122 

121 

507 

Summary of Benefits 

Pharmacy Directories 

Comprehensive Formularies 

Enrollment Forms 

Advertisements 

*Response rate is based on 113 PDPs because 2 PDP responded that enrollment forms were not produced for
 

calendar year 2007. 

**Response rate is based on 85 PDPs because 30 sponsors responded that they did not produce 

advertisements.

 Source: OIG collection of PDP marketing materials, 2007. 

Material review. We received training in March 2007 from staff in CMS’s 

New York regional office. This training covered an overview of the 

marketing guidelines, guidelines for specific types of marketing 

materials, and the region’s process for reviewing marketing materials. 

After the training, we developed and used five review guides, one for 

each type of marketing material. We divided CMS’s guidelines into 

separate elements for each material. The review guides included all 

requirements for each type of material based on the marketing 

guidelines and the Enrollment Guidelines. During the course of our 

review and analysis, we eliminated certain elements because we were 

unable to clearly interpret the guidelines for these elements. 

Four analysts reviewed the marketing materials. We reviewed each 

type of marketing material three or more times using the elements in 

the appropriate review guide. We entered the results into a Microsoft 

Access® database and used SAS® and SAS®-callable SUDAAN to 

analyze data from this review. During our review process, we 

performed quality assurance reviews to ensure uniform interpretation 

of the elements. These analyses included consistency checks by date of 

review, reviewer, and type of material. 

We also reviewed the standardized SB, as well as model documents for 

the enrollment form, the comprehensive formulary, and the pharmacy 

directory. We assessed them against the guidelines by using the review 

guides. 

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Δ APPENDIX ~ B 

Estimates and Confidence Intervals 

Estimates Discussed in Finding 1: Centers for Medicare & Medicaid Services’ (CMS) Oversight for PDP Marketing 

Materials Is Limited 

Estimate Description 

Point 

Estimates 95-Percent Confidence Intervals 

The unique identification numbers (material IDs) on materials did not 

match the material ID in the Health Plan Management System (HPMS). 45.4% 40.0%–50.8% 

Material IDs did not follow the proper format. 21.1% 14.8%–27.3% 

The material ID on the advertisements directory did not match a material 

ID in the HPMS. 42.3% 36.8%–47.8% 

The material ID on the comprehensive formulary did not match a material 

ID in the HPMS. 53.2% 43.0%–-63.5% 

The material ID on the enrollment form did not match a material ID in the 

HPMS. 39.6% 29.6%–49.7% 

The material ID on the pharmacy directory did not match a material ID in 

the HPMS. 47.7% 36.8%–-58.7% 

The material ID on the summary of benefits did not match a material ID in 

the HPMS. 51.3% 41.1%–61.5% 

The material ID on the advertisements did not follow the proper format. 13.8% 7.8%–19.7% 

The material ID on the comprehensive formulary did not follow the proper 

format. 32.4% 22.8%–42.0% 

The material ID on the enrollment form did not follow the proper format. 18.4% 10.6%–26.2% 

The material ID on the pharmacy directory did not follow the proper format. 39.7% 29.5%–50.1% 

The material ID on the summary of benefits did not follow the proper 

format. 18.8% 11.0%–26.6% 

Estimates Discussed in Finding 2: CMS’s Model Documents Are Not Consistent With Its Guidelines 

The summary of benefits did not direct the beneficiary to either the State 

Medicaid agency or Social Security Administration. 94.9% 88.1%–97.9%* 

The enrollment form did not include a statement that if the beneficiary 

enrolls in more than one plan, the last choice will be the one to take effect. 100% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

The enrollment form did not explain that enrollment in a PDP automatically 

disenrolls the beneficiary from any other PDP, MA plan, or Program of All 

Inclusive Care for the Elderly (PACE) plan. 

88.3% 81.5%–95.0% 

The enrollment form does not explain the expected date of enrollment in 

the PDP. 88.0% 81.2%–94.7% 

The enrollment form does not state that the PDP contracts with the 

Federal Government. 69.3% 59.9%–78.7% 

The enrollment form did not include the statement that it is available in 

alternative formats. 84.7% 77.2%–92.3% 

The summary of benefits included the statement that it is available in 

alternative formats. 99.6% 98.9%–99.8%* 

* Confidence interval calculated using the logit transformation because of poor coverage properties of the standard approximation method when a 

small or large number of sample elements possess the characteristic of interest. 

 Source: Office of Inspector General (OIG) analysis of marketing material reviews, 2007. 

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APPENDIX ~ B 

Estimates Discussed in Finding 2: CMS’s Model Documents Are Not Consistent With Its Guidelines (continued) 

Estimate Description 

Point 

Estimates 95-Percent Confidence Intervals 

The enrollment form did not include hours of operation with 

1-800-MEDICARE in all places. 84.6% 77.0%–92.1% 

The summary of benefits did not include hours of operation with 

1-800-MEDICARE in all places. 86.4% 79.3%–93.4% 

The enrollment form did not include a TTY/TDD number in conjunction 

with all 1-800-MEDICARE appearances. 37.5%** 27.7%–47.3% 

The comprehensive formulary did not include a TTY/TDD number in 

conjunction with all customer service number appearances. 0.1% 0.03%–0.7%* 

The comprehensive formulary did not include hours of operation with 

1-800-MEDICARE in all places. 0% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

 “You may be able to get extra help to pay for your prescription drug 

premiums and costs” was not included in the summary of benefits. 98.4% 93.5%–99.6%* 

Estimates Discussed in Finding 3: PDP Marketing Materials Did Not Consistently Meet CMS Guidelines 

Materials had at least one element that did not meet the guidelines. 85.1% 82.0%–88.2% 

The enrollment form had at least one element that did not meet the 

guidelines. 100% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

The summary of benefits had at least one element that did not meet the 

guidelines. 100% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

The comprehensive formulary had at least one element that did not meet 

the guidelines. 96.5%** 89.8%–98.9%* 

The pharmacy directory had at least one element that did not meet the 

guidelines. 86.2% 79.2%–93.2% 

The advertisements had at least one element that did not meet the 

guidelines. 72.9% 66.9%–78.9% 

The mean number of elements that did not meet the guidelines for the 

enrollment form. 10.2 9.7–10.8 

The mean number of elements that did not meet the guidelines for 

summary of benefits. 9.0 8.7–9.3 

The mean number of elements that did not meet the guidelines for the 

comprehensive formulary. 2.0 1.9–2.2 

The mean number of elements that did not meet the guidelines for the 

pharmacy directory. 2.2 1.8–2.5 

* Confidence interval calculated using the logit transformation because of poor coverage properties of the standard approximation method when a 

small or large number of sample elements possess the characteristic of interest. 

**Number is not the same as in the text because of rounding. 

 Source: OIG analysis of PDP marketing material reviews, 2007.
 

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APPENDIX ~ B 

Estimates Discussed in Finding 3: PDP Marketing Materials Did Not Consistently Meet CMS Guidelines (continued) 

Estimate Description 

Point 

Estimates 95-Percent Confidence Intervals 

The mean number of elements that did not meet the guidelines for 

advertisements. 1.1 1.0–1.3 

The average percent of elements not meeting the guidelines for 

enrollment forms. 17.0% 16.1%–17.9% 

The average percent of elements not meeting the guidelines for 

summaries of benefits. 17.7% 17.1%–18.3% 

The average percent of elements not meeting the guidelines for 

comprehensive formularies. 5.2% 4.8%–5.7% 

The average percent of elements not meeting the guidelines for pharmacy 

directories. 8.1% 6.8%–9.3% 

The average percent of elements not meeting the guidelines for 

advertisements. 4.9% 4.3%–5.5% 

Where cobranding was present on the advertisement, the advertisement 

did not include the statement “<Other Pharmacies/Physicians/Providers> 

are available in our network.” 

79.2% 72.5%–85.9% 

The pharmacy directory did not include the process for beneficiaries to 

follow if their mail order prescription was delayed. 41.6% 31.0%–52.2% 

Where the pharmacy directory did not include the process for 

beneficiaries to follow if their prescription was delayed, it stated that the 

sponsor will call the beneficiary. 

85.2% 74.3%–96.2% 

The mail order section in the pharmacy directory did not include a toll-free 

number and a TTY/TDD number. 31.3% 21.6%–41.0% 

The comprehensive formulary did not contain an index. 16.6% 8.8%–24.3% 

Source: OIG analysis of PDP marketing material reviews, 2007. 

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Δ APPENDIX ~ C 

Number of Elements Not Meeting the Centers for Medicare & Medicaid Services’ Guidelines in 

Each Type of Marketing Material 

TABLE 10 

Number of 

Elements That Did 

Not Meet 

Guidelines for
 

Enrollment Form 

Number of Elements Not 

Met 

Percentage of Enrollment 

Forms 95-Percent Confidence Intervals 

0-4 0% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

5 11.7% 5.0%–18.5% 

6-7 0% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

8 0.9% 0.3%–2.6%* 

9 21.9% 13.3%–30.4% 

10 30.7% 21.2%–40.2% 

11 1.9% 0.6%–6.3%* 

12 12.0% 5.6%–18.5% 

13 5.0% 0.5%–9.5% 

14 15.9% 8.3%–23.4% 

* Confidence interval calculated using the logit transformation because of poor coverage properties of the 

standard approximation method when a small number of sample elements possess the characteristic of interest. 

Source: Office of Inspector General (OIG) analysis of Prescription Drug Plan (PDP) marketing materials, 2007. 

Based on 60 elements. 

TABLE 11 

Number of 

Elements That Did 

Not Meet 

Guidelines for 

Summary of 

Benefits 

Number of Elements Not 

Met 

Percentage of Summaries 

of Benefits 95-Percent Confidence Intervals 

0-3 0% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

4 1.2% 0.2%–7.7%* 

5 0.3% 0.1%–0.9%* 

6 1.2% 0.2%–7.7%* 

7 12.6% 5.8%–19.4% 

8 15.0% 7.6%–22.2% 

9 39.1% 29.1%–49.1% 

10 15.5% 8.2%–22.9% 

11 7.2% 1.8%–12.6% 

12 7.2% 1.8%–12.6% 

13 0.6% 0.3%–1.2%* 

14-17 0% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

18 0.2% 0.03%–0.7%* 

* Confidence interval calculated using the logit transformation because of poor coverage properties of the 

standard approximation method when a small number of sample elements possess the characteristic of interest. 

Source: OIG analysis of PDP marketing materials, 2007. Based on 51 elements. 

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APPENDIX ~ C 

TABLE 12 

Number of 

Elements That Did 

Not Meet 

Guidelines for 

Comprehensive 

Formulary 

Number of Elements Not 

Met 

Percentage of Comprehensive 

Formularies 95-Percent Confidence Intervals 

0 3.5% 1.2%–10.3%* 

1 25.2% 16.4%–34.1% 

2 37.8% 28.0%–47.8% 

3 32.4% 22.7%–42.1% 

4 0.9% 0.5%–1.6%* 

5-13 0% 

Unable to quantify sampling error 

because review outcomes for all 

sample materials were the same 

14 0.2% 0.03%–0.7%* 

* Confidence interval calculated using the logit transformation because of poor coverage properties of the standard
 

approximation method when a small number of sample elements posses the characteristic of interest. 

Source: OIG analysis of PDP marketing materials, 2007. Based on 39 elements. 

TABLE 13 

Number of 

Elements That Did 

Not Meet 

Guidelines for 

Pharmacy Directory 

Number of Elements Not 

Met 

Percentage of Pharmacy 

Directories 95-Percent Confidence Intervals 

0 13.8% 6.8%–20.8% 

1 30.1% 20.4%–39.8% 

2 11.5% 5.5%–17.5% 

3 18.3% 10.7%–25.9% 

4 24.5% 14.7%–34.4% 

5 0.1% 0.03%–0.7%* 

6 0.6% 0.2%–1.4%* 

7 1.1% 0.2%–7.3%* 

* Confidence interval calculated using the logit transformation because of poor coverage properties of the standard
 

approximation method when a small number of sample elements posses the characteristic of interest. 

Source: OIG analysis of PDP marketing materials, 2007. Based on 27 elements. 

TABLE 14 

Number of 

Elements That Did 

Not Meet 

Guidelines for 

Advertisements 

Number of Elements Not 

Met Percentage of Advertisements 95-Percent Confidence Intervals 

0 27.1% 21.1%–33.0% 

1 37.2% 33.5%–40.9% 

2 32.8% 24.9%–40.8% 

3 2.0% 1.0 % –4.3%* 

4 0.4% 0.2 %–0.8%* 

5 0.3% 0.1 %–2.5% * 

* Confidence interval calculated using the logit transformation because of poor coverage properties of the standard
 

approximation method when a small number of sample elements posses the characteristic of interest. 

Source: OIG analysis of PDP marketing materials, 2007. Based on 23 elements. 

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Agency Comments 

Δ APPENDIX ~ D
 

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APPENDIX ~ D 
 

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APPENDIX ~ D 
 

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APPENDIX ~ D 
 

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APPENDIX ~ D 
 

 

Δ ACKNOWLEDGMENTS 

This report was prepared under the direction of Joyce M. Greenleaf, 

Regional Inspector General for Evaluation and Inspections in the 

Boston regional office, and Russell W. Hereford, Deputy Regional 

Inspector General. 

Maria Maddaloni served as the team leader for this study. Other 

principal Office of Evaluation and Inspections staff from the Boston 

regional office who contributed to the report include Bailey G. Orshan 

and Robyn Sterling; central office staff who contributed include 

Linda B. Abbott, Kevin Farber, Sandy Khoury, and Megan Ruhnke. 

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