Department of Health and Human Services
 
OFFICE OF 

 
INSPECTOR GENERAL 

 
 
 
 
 
 
 
 
M   M
ARKETING  ATERIALS FOR 

 
M P  
ED ICARE  RESCRIPTION 

 
D P  
RUG  LANS
 
 
 
 
 
 
 
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 OIGs  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.    
   
  E X E C U T I V E   S U M M A R Y  
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. 
CMSs 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 CMSs oversight of PDP materials based on the oversight  
strategies outlined in its guidelines.  We used CMSs guidelines, 
regulations, responses to oral and written questions, and data from 
CMSs Health Plan Management System (HPMS) to assess its oversight 
of the materials.  To determine whether marketing materials met  
CMSs guidelines, we reviewed marketing materials from a stratified  
simple random sample of 115 PDPs offered in 2007.  All estimates in our 
  OEI-01-06-00050  MARKETING  MATERIALS FOR  MEDICARE PRESCRIPTION DRUG PLANS   i   
   
E  E XX EE CC UU TT II VV EE   SS UU MM MM AA RR YY  
report are projectable to the population of PDPs for each type of 
material. We also reviewed model documents using these same review 
guides.    
FINDINGS 
CMSs 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. 
CMSs 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 CMSs 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 
OEI-01-06-00050  MARKETING  MATERIALS FOR  MEDICARE PRESCRIPTION DRUG PLANS   ii   
   
E X E C U T I V E   S U M M A R Y  
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 CMSs 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 CMSs 
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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E X E C U T I V E   S U M M A R Y   
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, CMSs 
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 CMSs marketing and enrollment 
guidelines. 
  OEI-01-06-00050  MARKETING  MATERIALS FOR  MEDICARE PRESCRIPTION DRUG PLANS   iv   
  
  TT AA BB LL EE    OO FF    CC OO NN TT EENNTTSS    
 
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  i
  
 
 
I N T RO DUC T IO N  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1 
  
 
 
F I N D IN G S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  9 
  
  CMSs oversight is limited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  9 
  
  CMSs model documents are not consistent with guidelines. . . . .  12 
  
  PDP marketing materials did not consistently meet guidelines. .  17 

   
R E C O MMEN D A T ION S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  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 CMSs Guidelines in 

Each Type of Marketing Material  . . . . . . . . . . . . . . . . . . . . . .  29 
  
  D:	  Agency Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  31 
  
 
 
A C K NO WL E D G M E N T S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  36 
    
   
B A N N E R   2 N D   P A G E  
  I N T R O D U C T I O N   
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). 
 
  OEI-01-06-00050   MARKETING  MATERIALS FOR  MEDICARE PRESCRIPTION  DRUG  PLANS   1   
   
I N T R O D U C T I O N
   
Type of Material   Purpose 
TABLE 1 
Description of   Advertisements  Used to attract potential enrollees.  Includes materials such as 
newspaper advertisements, marketing posters, and fliers  
Types of PDP 
Marketing  Summary  of Benefits  Provides general  information on PDP guidelines and benefits 
Materials Reviewed 
Comprehensive Formulary  Conveys details about covered drugs and the level of coverage 
in This Evaluation 
  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 CMSs 
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 CMSs 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 GuidanceEligibility, 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 GuidanceEligibility, 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. 
  OEI-01-06-00050   MARKETING  MATERIALS FOR  MEDICARE PRESCRIPTION  DRUG  PLANS   2   
   
I N T R O D U C T I O N   
data elements that must be collected to complete  the beneficiarys 
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 PDPs 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 CMSs Health Plan 
Management System (HPMS).  The HPMS combines boilerplate 
language with specific information from a PDPs 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 CMSs 
model documents and does not modify the language or sequence  
 
5  CMS, Medicare Marketing Guidelines, pp. 15 and 35. 
  OEI-01-06-00050   MARKETING  MATERIALS FOR  MEDICARE PRESCRIPTION  DRUG  PLANS   3   
   
II NN TT RR OO DD UU CC TT II OO NN    
used in the model documents (other than specifics about the 
individual PDPs 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.   CMSs 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 PDPs 
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. 100101.  
13 CMS, Medicare Marketing Guidelines, p. 98. 
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I N T R O D U C T I O N   
PDP sponsors to use file & use for at least 90 percent of materials that 
qualify for this process.14    
FIGURE 1  Type of marketing material 
Flow Chart of the 
Review Process 
Advertisements*  Pharmacy directory,   Enrollment form, 
for Selected PDP    Comprehensive formulary   Summary of benefits 
Marketing 
Materials 
Can be submitted as  Use unmodified model  Use unmodified model 
  file & use 5 days prior  documents?  documents? 
to distribution  
Yes  No  Yes 
10-day 
Can be submitted as  45-day 
standard 
file & use 5 days prior  standard 
review 
to distribution or 10-day  review 
standard review   
* Model documents are not offered for 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.   CMSs 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. 9899.  
16  CMS, Medicare Marketing Guidelines, p. 109.  
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I N T R O D U C T I O N   
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 sponsors contract number,  a series of digits of the sponsors  
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 Care1998 Marketing Materials, OEI-03-98-00271,   
February 2000.  Medicare + Choice was the previous name for Medicare Advantage plans. 
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I N T R O D U C T I O N   
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. 
METHODOLOGY 
Scope 
We assessed CMSs 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 CMSs 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 CMSs 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 Medicare-
Approved 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 2004December 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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III NNN TTT RRR OOO DDD UUU CCC TTT III OOO NNN     
To determine whether marketing materials met  CMSs 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 CMSs 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 CMSs New 
York regional office. This training covered an overview of the 
marketing guidelines, guidelines for specific types of marketing 
materials, and the regions process for reviewing marketing materials. 
For a detailed methodology, see Appendix A.  
Limitations 
This study did not assess CMSs 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 Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency. 
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  F I N D I N G S  
 
CMSs oversight for PDP marketing materials is  CMSs 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 sponsors 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 CMSs 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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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 Care1998 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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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 OIGs 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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Material  Percentage of Material  Percentage of Material
TABLE 2 
IDs That Did Not Match  IDs That Did Not Follow  
Percentage of 
Material IDs in the HPMS  Proper Format  
Material IDs  Not 
Advertisements  42%  14% 
Matching the HPMS 
and Not Following  Comprehensive Formulary  53%  32% 
Proper Format  Enrollment Form   40%  18% 
  Pharmacy Directory   48%  40% 
Summary of Benefits  51%  19% 
All materials  45%   21%  
  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 
CMSs ability to monitor the content of the materials through a 
verification review.  
 
CMSs 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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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  Required Language From CMS Marketing  Language From CMSs Standardized SB 
Guidelines  
 Comparison  of 
CMS Marketing  All Part D plan preenrollment marketing materials  If you  qualify  for extra help with your 
Guidelines and  detailing eligibility requirements, monthly   Medicare prescription drug plan costs, 
Standardized SB   premiums and other member costs for Part D  your premium and costs at the pharmacy  
Language for LIS   benefits must include the following language in  will be lower. When you join [PDP name], 
paragraph or bullet form:  Medicare  will tell us how  much extra help 
You may be able to get extra help to pay for your  you are getting. Then we will let you know  
prescription drug premiums and costs. To see if  the amount you will pay.  If you are not 
you qualify for getting extra help, call:  getting this extra help you can see if you 
  1-800-MEDICARE  (1-800-633-4227).  qualify  by calling 1-800-Medicare 
TTY/TDD users should call 1-877-486-2048,  (1-800-633-4227). TTY/TTD users should 
24 hours a day/7days a week);  call 1-877-486-2048. 
   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 
  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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Enrollment information lacks some required elements  
According to the Enrollment Guidelines, [t]he  PDP sponsors 
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 
PDPs 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 CMSs 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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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, CMSs 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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Guidelines   Type of Material  Included  Percentage 
TABLE 4 
in Model?  Missing 
Comparison of    
From 
Guidelines,  Marketing 
Materials, and  Materials 
Required  Organizations must also list the  Enrollment Form   No  85% 
Information   hours of operation for 1-800-
Summary of Benefits  No  86% 
MEDICARE anytime the organization 
lists the 1-800-MEDICARE number  Comprehensive  Yes  0%  
Formulary 
The Medicare TTY/TDD number  Enrollment Form   No  37% 
must appear in conjunction with  
1-800-MEDICARE   
TTY/TDD numbers must appear in   Comprehensive  Yes   < 1%   
conjunction with all other phone  Formulary 
numbers 
  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. 3435.  
56  HHS, OIG, Identifying Beneficiaries Eligible for the Medicare Part D Low-Income 
Subsidy, OEI-03-06-00120, November 2006.  
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TABLE 5    Required Elements From CMS Marketing  Language From CMSs 
Guidelines   Standardized SB  
Comparison of CMS 
Marketing  If enrolled in an MA coordinated care (HMO or  Eligible individuals may  only enroll 
Guidelines and  PPO) plan or an MA PFFS plan that includes  in one Medicare Prescription Drug  
Standardized SB   Medicare prescription drugs, the enrollee may  not  Plan at a time and may not be 
enroll in a PDP unless they disenroll from the HMO,  enrolled in a Medicare Advantage 
Language for 
PPO or MA PFFS plan.   Plan (HMO, PPO), unless they are a 
Enrollment  
  member of Medicare Private-Fee-
Information  
Enrollees in a private fee-for-service plan (PFFS)  For Services plan or are enrolled in 
that does not provide Medicare prescription drug  an 1876 Cost Plan. 
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 CMSs 
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).   
Material  Percentage of Materials Not Following CMS 
TABLE 6 
Guidelines for One or More Elements 
Percentage of PDP 
Marketing  Enrollment Form   100% 
Materials That Fail  Summary of Benefits  100% 
To Meet CMS  Comprehensive Formulary  96% 
Guidelines for One 
Pharmacy Directory   86% 
or More Elements 
Advertisements  73% 
 
All materials  85%  
  Source:  OIG analysis of PDP marketing materials, 2007.  
 
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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  Average Number  of Number of    Average Percentage 
TABLE 7 
Elements Not  Elements  of Elements Not 
Average Number and 
Meeting CMS  Reviewed for  Meeting CMS 
Percentage of  Guidelines   Each Type  Guidelines  
Elements of CMS   of Material 
Guidelines That PDP 
Enrollment Form   10  60  17% 
Marketing Materials 
Summary of Benefits  9  51  18% 
Fail To Meet 
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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sponsors 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. 6061.  
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  R E C O M M E N D A T I O N S   
 
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 CMSs model documents and its guidelines.  
Information inaccurately conveyed in or omitted from the materials may 
affect a beneficiarys 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 CMSs 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 Care1998 Marketing Materials, OEI-03-98-00271, 
February 2000.  
65  Ibid. 
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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 CMSs 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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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, CMSs 
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 CMSs marketing and enrollment 
guidelines. 
The complete text of CMSs comments can be found in Appendix D. 
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  A P P E N D I X   ~   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 CMSs 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 CMSs 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 
agencys 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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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).  
Stratum Definitions  Number of   Number of   Number of   Number of  
TABLE 8 
Plans in  Sponsors  Plans in  Sponsors in 
Strata 
Population  in  Sample  Sample 
Characteristics   Population 
Plans from sponsors  92  40  35  25 
offering total of four 
plans or fewer 
 
Plans from sponsors  1,671  25  80  20 
offering total of five 
or more plans 
 
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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TABLE 9  Type of Material  Number of PDPs  Response  Sample Size of 
That Responded   Rate  Materials 
Response Rates   
and Total Number 
Summary of Benefits  115  100%  122 
of Materials in  
Sample   Pharmacy Directories  112  97%  144 
Comprehensive Formularies  115  100%  122 
Enrollment Forms  113  100%*  121 
Advertisements  71  84%**  507 
  *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 CMSs  
New York regional office.  This training covered an overview of the 
marketing guidelines, guidelines for specific types of marketing 
materials, and the regions process for reviewing  marketing materials. 
After the training, we developed and  used five review guides, one for  
each type  of marketing material.  We divided CMSs 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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Estimates and Confidence Intervals  
 
Estimates Discussed in Finding 1:   Centers for Medicare & Medicaid Services (CMS)  Oversight for PDP Marketing  
Materials Is Limited  
Point 
Estimate Description   Estimates  95-Percent Confidence Intervals 
The unique identification numbers (material IDs) on materials did not 
45.4%  40.0%50.8% 
match the material ID in the Health Plan Management System (HPMS).   
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 
42.3%  36.8%47.8% 
ID in the HPMS.   
The material ID on the comprehensive formulary did not match a material 
53.2%  43.0%-63.5%  
ID in the HPMS.   
The material ID on the enrollment form did not match a material ID in the 
39.6%  29.6%49.7% 
HPMS. 
The material ID on the pharmacy  directory did not match a material ID in 
47.7%  36.8%-58.7%  
the HPMS. 
The material ID on the summary of benefits did not match a material ID in 
51.3%  41.1%61.5% 
the HPMS. 
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 
32.4%  22.8%42.0% 
format. 
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 
18.8%  11.0%26.6% 
format. 
Estimates Discussed in Finding 2:  CMSs Model Documents Are Not Consistent With Its Guidelines 
The summary of benefits did not direct the beneficiary to either the State 
94.9%  88.1%97.9%* 
Medicaid agency or Social Security Administration.  
Unable to quantify sampling error 
The enrollment form did not include a statement that if the beneficiary  
100%  because review  outcomes for all 
enrolls in more than one plan, the last choice will be the one to take effect. 
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  88.3%  81.5%95.0% 
Inclusive Care for the Elderly  (PACE) plan. 
The enrollment form does not explain the expected date of enrollment in 
88.0%  81.2%94.7% 
the PDP. 
The enrollment form does not state that the PDP contracts with the 
69.3%  59.9%78.7% 
Federal Government. 
The enrollment form did not include the statement that it is available in 
84.7%  77.2%92.3% 
alternative formats. 
The summary of benefits included the statement that it is available in 
99.6%  98.9%99.8%* 
alternative formats. 
* 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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Estimates Discussed in Finding 2:  CMSs Model Documents Are Not Consistent With Its Guidelines  (continued) 
Point 
Estimate Description  Estimates  95-Percent Confidence Intervals 
The enrollment form did not include hours of operation with  
84.6%  77.0%92.1% 
1-800-MEDICARE in all places. 
The summary of benefits did not include hours of operation with  
86.4%  79.3%93.4% 
1-800-MEDICARE in all places. 
The enrollment form did not include a TTY/TDD number in conjunction 
37.5%**  27.7%47.3% 
with all 1-800-MEDICARE appearances. 
The comprehensive formulary did not include a TTY/TDD number in  
0.1%  0.03%0.7%* 
conjunction with all customer service number appearances. 
Unable to quantify sampling error 
The comprehensive formulary did not include hours of operation with   
0%  because review  outcomes for all 
1-800-MEDICARE in all places. 
sample materials were the same 
 You may be able to get extra help to pay for your prescription drug  
98.4%  93.5%99.6%* 
premiums and costs was not included in the summary of benefits. 
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% 
Unable to quantify sampling error 
The enrollment form had at least one element that did not meet the  
100%  because review  outcomes for all 
guidelines. 
sample materials were the same 
Unable to quantify sampling error 
The summary of benefits had at least one element that did not meet the 
100%  because review  outcomes for all 
guidelines. 
sample materials were the same 
The comprehensive formulary had at least one element that did not meet 
96.5%**  89.8%98.9%* 
the guidelines. 
The pharmacy directory had at least one element that did not meet the 
86.2%  79.2%93.2% 
guidelines. 
The advertisements had at least one element that did not meet the 
72.9%  66.9%78.9% 
guidelines. 
The mean number of elements that did not meet the guidelines for the 
10.2  9.710.8 
enrollment form.   
The mean number of elements that did not meet the guidelines for 
9.0  8.79.3 
summary of benefits.   
The mean number of elements that did not meet the guidelines for the 
2.0  1.92.2 
comprehensive formulary.   
The mean number of elements that did not meet the guidelines for the 
2.2  1.82.5 
pharmacy directory.  
* 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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Estimates Discussed in Finding 3:  PDP Marketing Materials Did Not Consistently Meet CMS Guidelines (continued)  
Point 
Estimate Description  Estimates  95-Percent Confidence Intervals 
The mean number of elements that did not meet the guidelines for 
1.1  1.01.3 
advertisements. 
The average percent of elements not meeting the guidelines for 
17.0%  16.1%17.9% 
enrollment forms.   
The average percent of elements not meeting the guidelines for 
17.7%  17.1%18.3% 
summaries of benefits. 
The average percent of elements not meeting the guidelines for 
5.2%  4.8%5.7%  
comprehensive formularies. 
The average percent of elements not meeting the guidelines for pharmacy  
8.1%  6.8%9.3%  
directories. 
The average percent of elements not meeting the guidelines for 
4.9%  4.3%5.5%  
advertisements. 
Where cobranding was present on the advertisement, the advertisement 
did not include the statement <Other Pharmacies/Physicians/Providers>  79.2%  72.5%85.9% 
are available in our network. 
The pharmacy directory did not include the process for beneficiaries to 
41.6%  31.0%52.2% 
follow if their mail order prescription was delayed. 
Where the pharmacy directory did not include the process for 
beneficiaries to follow if their prescription was delayed, it stated that the  85.2%  74.3%96.2% 
sponsor will call the beneficiary. 
The mail order section in the pharmacy directory did not include a toll-free 
31.3%  21.6%41.0% 
number and a TTY/TDD number. 
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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Number of Elements Not Meeting the Centers for Medicare & Medicaid Services Guidelines in 
Each Type of Marketing Material   
TABLE 10 
 Number of Elements Not  Percentage of Enrollment  95-Percent Confidence Intervals 
Met  Forms 
Number of 

Elements That Did 
 Unable to quantify sampling error 
Not Meet 
 0-4  0%  because review  outcomes for all 
Guidelines for
   sample materials were the same 
Enrollment Form  
 5  11.7%  5.0%18.5% 
 
Unable to quantify sampling error 
6-7  0%  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 Not   Percentage of Summaries   95-Percent Confidence Intervals 
Met  of Benefits 
Number of 
Elements That Did  Unable to quantify sampling error 
Not Meet  0-3  0%  because review  outcomes for all 
Guidelines for   sample materials were the same 
Summary of  4  1.2%  0.2%7.7%* 
Benefits 
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%* 
Unable to quantify sampling error 
14-17  0%  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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TABLE 12  Number of Elements Not  Percentage of Comprehensive  95-Percent Confidence Intervals 
Met  Formularies 
Number of 
Elements That Did  0  3.5%  1.2%10.3%* 
Not Meet 
1  25.2%  16.4%34.1% 
Guidelines for  
2  37.8%  28.0%47.8% 
Comprehensive 
Formulary  3  32.4%  22.7%42.1% 
  4  0.9%  0.5%1.6%* 
Unable to quantify sampling error 
5-13  0%  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 Not  Percentage of Pharmacy   95-Percent Confidence Intervals 
Met  Directories 
Number of 
Elements That Did  0  13.8%  6.8%20.8% 
Not Meet 
1  30.1%  20.4%39.8% 
Guidelines for  
2  11.5%  5.5%17.5% 
Pharmacy Directory 
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 Not  Percentage of  Advertisements   95-Percent Confidence Intervals 
Met 
Number of 
Elements That Did  0  27.1%  21.1%33.0% 
Not Meet 
1  37.2%  33.5%40.9% 
Guidelines for  
2  32.8%  24.9%40.8% 
Advertisements 
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 
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  A C K N O W L E D G M E N T S  
 
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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