This is the accessible text file for GAO report number GAO-08-719 
entitled 'Medicare Part D: Complaint Rates Are Declining, but 
Operational and Oversight Challenges Remain' which was released on July 
29, 2008.

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as part 
of a longer term project to improve GAO products' accessibility. Every 
attempt has been made to maintain the structural and data integrity of 
the original printed product. Accessibility features, such as text 
descriptions of tables, consecutively numbered footnotes placed at the 
end of the file, and the text of agency comment letters, are provided 
but may not exactly duplicate the presentation or format of the printed 
version. The portable document format (PDF) file is an exact electronic 
replica of the printed version. We welcome your feedback. Please E-mail 
your comments regarding the contents or accessibility features of this 
document to Webmaster@gao.gov. 

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

This report was changed as of 7/1/08 to add Appendix II, which is the 
agency comment letter that was inadvertently left out of the report. 

Report to Congressional Requesters: 

United States Government Accountability Office: 
GAO: 

June 2008: 

Medicare Part D: 

Complaint Rates Are Declining, but Operational and Oversight Challenges 
Remain: 

GAO-08-719: 

GAO Highlights: 

Highlights of GAO-08-719, a report to congressional requesters. 

Why GAO Did This Study: 

Medicare Part D coverage is provided through plan sponsors that 
contract with the Centers for Medicare & Medicaid Services (CMS). As of 
April 2008, about 26 million beneficiaries were enrolled in Part D. 
When beneficiaries encounter problems with Part D, they can either file 
a complaint with CMS or a grievance with their plan sponsors. CMS 
centrally tracks complaints data and plan sponsors must report summary 
data on grievances for each of their contracts. GAO provided 
information on (1) complaints and what they indicate about 
beneficiaries’ experiences with Part D, (2) whether grievances data 
provide additional insight about beneficiaries’ experiences, and (3) 
CMS’s oversight of the complaints and grievances processes. To conduct 
its work, GAO reviewed CMS’s complaints and grievances data and 
interviewed the plan sponsors of eight, judgmentally selected 
contracts, which accounted for 40 percent of 2006 enrollment. 

What GAO Found: 

While the number of complaints filed with CMS and the time needed to 
resolve them has diminished as the Part D program has matured, 
complaints data indicate that ongoing challenges pose problems for some 
beneficiaries. From May 1, 2006, through October 31, 2007, about 
630,000 complaints were filed; most complaints were related to problems 
in processing beneficiaries’ enrollment and disenrollment requests. The 
monthly complaint rate declined by 74 percent over the period, and the 
average time needed to resolve complaints decreased from a peak of 33 
days to 9 days. However, trends in the complaints data also indicate 
ongoing implementation issues, such as information-processing issues 
related to beneficiaries’ requests for enrollment changes and automatic 
premium withholds from Social Security payments. In addition, CMS and 
plan sponsors did not resolve a significant proportion of complaints 
related to beneficiaries at risk of depleting their medications in 
accordance with applicable time frames. 

Due to limitations and anomalies, the grievances data that plan 
sponsors reported for their contracts did not provide sufficient 
insight into beneficiaries’ experiences with Part D. Specifically, 
these data did not include information about whether beneficiaries who 
filed grievances were at risk of depleting their medications or whether 
plan sponsors were resolving grievances in a timely manner. In 
addition, GAO identified a number of anomalies in the grievances data, 
raising questions about whether plan sponsors were reporting these data 
consistently and accurately. For example, reported grievances were 
concentrated in a small number of plan sponsors’ contracts and at a 
rate that was significantly disproportionate to their respective 
enrollment levels; varied considerably among contracts with similar 
levels of enrollment; and increased from 2006 to 2007, in contrast to 
patterns in complaints data. 

CMS’s oversight efforts thus far have focused almost exclusively on 
resolving complaints with little attention devoted to plan sponsors’ 
grievances processes. CMS routinely monitors the status of complaints 
and has taken actions against plan sponsors who failed to comply with 
requirements for the complaints process. In contrast, CMS oversight of 
plan sponsor grievances processes has been more limited. CMS provided 
plan sponsors with general guidance for classifying grievances and 
periodically reviewed these data. However, several plan sponsors 
indicated that the guidance was insufficient, increasing the likelihood 
that plan sponsors report erroneous and inconsistent information to CMS 
and that they rely on the wrong processes to address beneficiaries’ 
concerns. Further, CMS could not explain many of the anomalies in the 
grievances data that GAO identified. 

What GAO Recommends: 

GAO recommends that CMS undertake efforts to improve the consistency, 
reliability, and usefulness of grievances data. Such efforts include 
enhancing existing guidance, requiring plan sponsors to report 
additional information, and conducting systematic oversight of these 
data. The agency concurred with the recommendation and highlighted 
steps it has implemented or will consider to improve the quality of 
grievances data. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-719]. For more 
information, contact Kathleen M. King at (202) 512-7114 or 
kingk@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Complaints Data Highlight Beneficiaries' Enrollment Problems, Decline 
in Complaint Rates, and Ongoing Challenges: 

Limitations in Grievances Data Reported by Plan Sponsors for Their 
Contracts Prevent Reliable Assessment of Beneficiaries' Experiences 
with Part D: 

CMS's Oversight Focused on Complaints and Not Grievances, Leaving 
Oversight Gaps: 

Conclusions: 

Recommendations: 

Agency Comments: 

Appendix I: CMS Medicare Part D Complaint and Grievance Categories: 

Appendix II: Comments from the Centers for Medicare & Medicaid 
Services: 

Tables: 

Table 1: CTM Complaints Categories: 

Table 2: CMS Grievances Categories: 

Figures: 

Figure 1: Part D Complaints and Grievances Processes: 

Figure 2: Range of Actions to Address Noncompliance in Order of 
Severity: 

Figure 3: Proportion of Medicare Part D Complaints Filed by CTM 
Category, May 2006-October 2007: 

Figure 4: Medicare Part D Complaint Rates per 1,000 Beneficiaries, May 
2006-October 2007: 

Figure 5: Average Resolution Times for Closed Complaints, May 2006- 
October 2007: 

Figure 6: Proportion of Immediate Need and Urgent Cases Closed but Not 
Meeting Time Frames: 

Abbreviations: 

CMS: Centers for Medicare & Medicaid Services: 

CSR: customer service representative: 

CTM: Complaint Tracking Module: 

HHS: Department of Health and Human Services: 

MA-PD: Medicare Advantage prescription drug: 

MMA: Medicare Prescription Drug, Improvement and Modernization Act of 
2003: 

OMO: Office of the Medicare Beneficiary Ombudsman: 

PBM: pharmacy benefit managers: 

PDP: prescription drug plan: 

SSA: Social Security Administration: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

June 27, 2008: 

Congressional Requesters: 

The Medicare Prescription Drug, Improvement and Modernization Act of 
2003 (MMA) established a voluntary outpatient prescription drug 
benefit, known as Medicare Part D.[Footnote 1] Considered the largest 
change to the Medicare program since 1965, the new benefit was intended 
to provide affordable prescription drug coverage to Medicare 
beneficiaries. Under the program, which began providing benefits on 
January 1, 2006, the Centers for Medicare & Medicaid Services (CMS)-- 
the agency that administers Medicare--contracts with private companies 
called plan sponsors to provide this benefit.[Footnote 2] Through these 
contracts, plan sponsors offer prescription drug plans which may have 
different beneficiary cost-sharing arrangements (such as copayments and 
deductibles) and charge different monthly premiums.[Footnote 3] In 
addition, while each plan may vary in the specific drugs it covers, all 
must provide coverage for drugs within certain categories.[Footnote 4] 

To obtain the Medicare drug benefit, eligible beneficiaries enroll in a 
specific Part D plan offered by a plan sponsor.[Footnote 5] 
Approximately 21 million people enrolled in a Medicare Part D plan 
during the program's initial enrollment period, which ran from November 
15, 2005, through May 15, 2006. Subsequent to the initial enrollment 
period, beneficiaries can enroll in a plan during the same time period 
when they become eligible for Medicare or change plans during the 
annual coordinated election period, which runs from November 15 through 
December 31 of each year. As of April 2008, nearly 26 million 
beneficiaries were enrolled in a Medicare Part D plan. As part of the 
enrollment process, beneficiaries can choose to pay for their share of 
premiums by having the Social Security Administration (SSA) 
automatically deduct them from their social security payments. CMS and 
SSA coordinate to ensure that this deduction occurs, and millions of 
beneficiaries have chosen this option. 

Soon after the implementation of Part D in January 2006, the Secretary 
of Health and Human Services (HHS), as well as beneficiary advocacy 
groups and states, reported various difficulties beneficiaries 
experienced when obtaining and utilizing their Part D benefits. 
[Footnote 6] For example, there were reports that beneficiaries 
experienced problems enrolling in plans and being charged incorrect 
copayments at the pharmacy. As the primary federal oversight body for 
Medicare Part D, CMS is responsible for ensuring that plan sponsors 
meet applicable requirements, which include resolving these and other 
problems that could affect a beneficiary's ability to obtain Part D 
benefits. 

Medicare beneficiaries who experience problems, such as difficulties in 
trying to enroll in a Part D plan, or cases when they were charged too 
much for their prescriptions, have two distinct processes through which 
they can pursue resolution. CMS has established a process through which 
a Medicare beneficiary can file a complaint directly with CMS, which 
will generally forward it to the appropriate plan sponsor for 
resolution, or a beneficiary has the right to file a complaint directly 
with the plan sponsor, in which case it is known as a grievance. 
[Footnote 7] Complaints are tracked and resolved through CMS's 
centralized complaints system, while grievances are tracked and 
resolved by each plan sponsor using its own systems. Through its 
outreach efforts, CMS encourages individuals to file grievances with 
their plan sponsors before pursuing a complaint with CMS; however, 
individuals can simultaneously file a complaint and grievance on the 
same issue. CMS's time frames for resolving complaints vary and depend 
on whether the complaint relates to a beneficiary's medication supply, 
that is, whether the beneficiary is at risk of exhausting his current 
medication supply unless the complaint is resolved. For example, CMS 
defines complaints as immediate need when a beneficiary has between 0- 
2 days of medication remaining, and according to its policy, plan 
sponsors must resolve such complaints within 2 calendar days of 
receiving them. In addition, it defines complaints as urgent when a 
beneficiary has between 3 and 14 days of medication remaining, and CMS 
officials encourage plan sponsors to resolve these complaints within 10 
calendar days.[Footnote 8] Part D regulations generally require that 
plan sponsors resolve grievances within 30 days.[Footnote 9] 
Additionally, if beneficiaries experience problems obtaining coverage 
from their Part D plan sponsor for a drug that has been prescribed for 
them, they must pursue resolution through a separate process known as a 
coverage determination. Under this process, beneficiaries make a formal 
request to their plan for coverage, and if they receive an unfavorable 
coverage determination, they may appeal the decision.[Footnote 10] 

You expressed interest in the extent to which beneficiaries may have 
experienced problems obtaining and utilizing their benefits under Part 
D, and the extent to which CMS has assured the resolution of such 
problems. This report provides information on (1) complaints filed with 
CMS and what they indicate about beneficiaries' experiences with Part 
D, (2) the extent to which plan sponsor-reported grievances data 
provide insight about beneficiaries' experiences with Part D, and (3) 
CMS's oversight of the complaints and grievances processes. 

To identify and analyze the Part D complaints reported to CMS, we 
obtained and analyzed data from CMS's Complaint Tracking Module (CTM) 
database on all complaints filed for the 18-month period from May 1, 
2006, the point at which CMS first began centrally tracking complaints, 
through October 31, 2007, the date for which CMS had the most complete 
complaints data for our purposes at the time of our request.[Footnote 
11] For this same time period, we also obtained from CMS information on 
the number of beneficiaries enrolled under the plans of each Part D 
contract. Based on the information which CMS collected for each 
complaint, including its category, or type of issue, and its filing and 
resolution dates, we conducted a series of analyses which allowed us to 
determine aggregate monthly complaint rates and summary statistics on 
the types of issues which generated the complaints. Through these 
analyses, we also determined the extent to which complaints were 
related to beneficiaries' medication supplies, the proportion of 
complaints that were resolved and their resolution times, and various 
trends over the 18-month period.[Footnote 12] We also interviewed CMS 
officials to obtain a more thorough understanding of the complaints 
data and to obtain their views regarding the trends our analyses 
identified. To assess the reliability of the complaints data, we 
reviewed CMS manuals and other policies for collecting, categorizing, 
and analyzing complaints, interviewed CMS officials responsible for 
collecting and analyzing the data, and conducted a series of electronic 
tests on the data file CMS provided. We determined that the data were 
sufficiently reliable for the purposes of this report. 

To determine whether plan sponsor-reported grievances data provided 
insight about beneficiaries' experiences with Part D, we obtained plan 
sponsor-reported grievances data from CMS for each quarter of calendar 
year 2006 and for the first 3 quarters of calendar year 2007. As of 
December 2007, these data represented the universe of grievances 
reported to CMS by plan sponsors. These grievances data, which plan 
sponsors are contractually required to report to CMS, contained summary 
statistics on the number and type of grievances reported for each Part 
D contract. Based on these reported grievances and CMS enrollment data 
described above, we conducted a series of analyses to determine the 
number and grievance rates by quarter and the types of issues which 
generated the grievances. However, while conducting our analyses we 
identified a number of limitations and anomalies, and thus we 
determined that the grievances data were too limited and not 
sufficiently reliable for us to draw conclusions regarding 
beneficiaries' experiences with Part D. 

To determine how CMS oversees the complaints and grievances processes, 
we reviewed relevant federal statutes and regulations, as well as 
available CMS guidance, including standard operating procedures, for 
tracking, monitoring, and resolving complaints and grievances. We 
reviewed other CMS data, including information on compliance actions 
taken by the agency against certain plan sponsors and the reasons for 
these actions, and separately reviewed CMS's audit findings pertaining 
to grievances. In addition, we interviewed officials from CMS's central 
office responsible for collecting and monitoring CTM data and for 
reviewing plan sponsor-reported grievances data. We also interviewed 
CMS officials in each of its 10 regional offices responsible for 
ensuring that complaints were entered into the CTM and were 
appropriately resolved. Finally, to identify plan sponsors' views on 
the extent to which CMS provided guidance and oversight for their 
grievances processes, we interviewed officials from eight plan 
sponsors. We selected these plan sponsors based on a number of factors, 
including variation in enrollment levels and grievance rates for some 
of their specific contracts.[Footnote 13] The information we obtained 
from these plan sponsor interviews was not generalized to all plan 
sponsors. 

In conducting our work we were unable to definitively determine the 
number of complaints and grievances filed since the inception of the 
Part D program, and thus assess the full range of implementation 
problems beneficiaries may have faced. CMS did not begin centrally 
collecting complaints until May 2006, and thus no information was 
readily available on complaints filed between January and April 2006. 
Further, because beneficiaries could have filed both a complaint and 
grievance on the same issue or filed more than one complaint or 
grievance on the same issue, complaints and grievances may be 
duplicative. In addition, for a variety of reasons, including the 
newness and uniqueness of the Part D program, we were unable to 
determine what an appropriate complaint rate should be. For example, 
CMS officials cautioned us about comparing the Part D complaint rate to 
that of the Medicare Part C program--which is designed to provide 
comprehensive medical coverage--because the Part D data reflect early 
implementation challenges, and because the goals of the two programs 
and thus, the nature of issues facing beneficiaries, differ. 

We conducted this performance audit from December 2006 to June 2008 in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

Results in Brief: 

Most complaints were related to enrollment and disenrollment issues and 
both the number of complaints and time needed to resolve them have 
decreased as the Part D program has matured; however, ongoing issues 
continue to pose challenges for some beneficiaries. Of the nearly 
630,000 complaints filed with CMS between May 1, 2006, and October 31, 
2007, about 63 percent were related to problems processing 
beneficiaries' enrollment and disenrollment requests, such as when 
enrollment records between CMS and plan sponsors differed or contained 
errors. Another 21 percent of complaints were related to the pricing 
and coinsurance category of complaints, and included problems with 
automatic premium deductions from beneficiaries' social security 
payments. Most complaints did not involve cases where beneficiaries 
were at risk of exhausting their medications while their disputes were 
pending, and virtually all complaints were documented as resolved. 
Beneficiaries reported fewer problems over time and their problems were 
resolved more quickly, according to our review. For example, between 
May 2006 and October 2007, the monthly complaint rate declined by 74 
percent, and from July 2006 to October 2007 the average resolution time 
decreased from a high of 33 days to 9 days. However, the complaints 
data also confirmed that information system coordination problems 
continue to pose challenges for some beneficiaries. For example, 
information processing issues between CMS and plan sponsors and between 
CMS and SSA contributed to spikes in the number of enrollment and 
premium withholding complaints during the months immediately following 
the end of the 2007 annual coordinated election period. Also, a 
substantial proportion of the most critical complaints--those filed 
when beneficiaries were at risk of exhausting their medications--were 
not resolved within CMS's applicable time frames. 

Due to data limitations and anomalies, plan sponsor-reported grievances 
data did not provide sufficient insight into beneficiaries' experiences 
with Part D. For example, in contrast to the data available about 
complaints, the grievances data reported by plan sponsors for their 
contracts did not include information about whether a grievance was 
related to beneficiaries at risk of exhausting medications or whether 
it was ultimately resolved. Therefore, we were unable to determine the 
extent to which beneficiaries' grievances related to medication supply 
issues, whether plan sponsors resolved the grievances, or whether 
grievances were resolved in a timely manner. In addition to their 
limited nature, we identified a number of anomalies in the grievances 
data that raised questions about whether these data were reported 
consistently and accurately. For example, grievances were concentrated 
in a small number of contracts, and at a rate that was significantly 
disproportionate to their respective enrollments. Specifically, in 2006 
plan sponsors reported grievances data for 522 contracts, 19 of which 
accounted for 80 percent of all grievances but only 49 percent of 
enrollment. The concentration was more pronounced in 2007, when 11 of 
the 604 contracts for which grievances data were reported accounted for 
90 percent of all grievances but only 42 percent of enrollment. We also 
found significant variations in the number of grievances reported for 
contracts with similar levels of enrollment. For example, in 2006, the 
two largest contracts each averaged about 3 million enrollees; however, 
grievances data indicated that one contract had 35 times the number of 
grievances than the other contract. 

CMS's oversight efforts thus far have focused almost exclusively on 
complaints, with little attention being paid to plan sponsors' 
grievances processes. Consequently, CMS has only partial assurance that 
beneficiaries' concerns have been addressed. To oversee complaints, CMS 
uses a structured framework that includes standard operating policies 
and procedures, a centralized repository of complaints data, and staff 
to review and assess trends in the complaints data. Through this 
framework, CMS routinely monitors the status of complaints and can take 
actions against plan sponsors who are noncompliant with process-related 
requirements. However, some gaps exist. For example, CMS does not 
verify, on a consistent basis, that plan sponsors have effectively 
resolved complaints, and in some cases, beneficiaries may deplete their 
medications before their complaints are resolved. In contrast, CMS 
oversight of plan sponsor grievances processes has been more limited. 
CMS provided plan sponsors with general guidance for classifying 
grievances, periodically reviewed plan sponsor grievances data, and 
audited some plan sponsors' grievances processes. However, several plan 
sponsors indicated that CMS's guidance for determining whether 
beneficiaries' problems should be considered grievances was 
insufficient, increasing the likelihood that plan sponsors report 
erroneous or inconsistent information to CMS and that they rely on the 
wrong processes to address beneficiaries' concerns. Further, although 
we found significant anomalies in the grievances data, CMS officials 
could not explain many of the anomalies and acknowledged that they had 
not undertaken efforts to review the data in detail or to assess their 
overall reliability. 

To improve oversight of the Medicare Part D grievances process, we 
recommend CMS take measures to enhance existing guidance, require plan 
sponsors to report additional information, and conduct systematic 
oversight of these data. In commenting on a draft of this report, the 
agency concurred with the recommendation and highlighted steps it has 
already taken to provide Part D sponsors with more comprehensive 
guidance for their grievances processes and to enhance its related 
oversight activities. CMS also stated that it would consider adding 
data elements related to plan sponsors' timeliness and quality of 
grievances resolution to its calendar year 2010 Reporting Requirements. 

Background: 

The Medicare Part D program offers beneficiaries an outpatient 
prescription drug benefit through various plan sponsors who offer 
coverage through drug plans, which may vary in terms of their benefits 
and costs. Enrollment in Part D consists of several steps and requires 
coordination among various organizations, such as CMS, plan sponsors, 
and SSA. If beneficiaries are not satisfied with certain aspects of the 
Part D program, they may file a complaint with CMS, a grievance with 
their respective plan sponsors, or they can file with both. CMS 
oversees the complaints and grievances processes and may rely on 
complaints and grievances data to undertake compliance actions against 
specific plan sponsors. 

The Medicare Part D Program: 

The Medicare Part D benefit is provided through private organizations-
-such as health insurance companies--that offer one or more drug plans 
with different levels of premiums, deductibles, and cost sharing. Part 
D plan sponsors offer outpatient prescription drug coverage either 
through stand-alone prescription drug plans (PDPs) for those in 
traditional fee-for-service Medicare, or through Medicare Advantage 
prescription drug (MA-PD) plans for beneficiaries enrolled in 
Medicare's managed care program, known as Medicare Advantage.[Footnote 
14] In 2007, CMS entered into more than 600 individual contracts with 
about 250 plan sponsors to provide Part D benefits.[Footnote 15] Under 
these contracts, PDP sponsors offered about 1,900 individual plan 
benefit packages and sponsors of MA-PDs offered about 1,700.[Footnote 
16] The majority of Part D enrollees, about 70 percent, were enrolled 
in PDPs during this time. Enrollment across contracts varies widely, 
and is highly concentrated--the 4 largest contracts accounted for 
nearly 40 percent of total Part D enrollment in 2007. 

Beneficiaries enroll in the Part D program when they first become 
eligible for Medicare or during an annual coordinated election period 
and, once enrolled in a drug plan, typically have one opportunity each 
year to change their plan selection.[Footnote 17] Processing a Part D 
enrollment involves multiple, timely, and accurate electronic data 
exchanges among federal agencies, private health plans, and pharmacies. 
For instance, data exchanges occur between plan sponsors and CMS to 
verify benefit eligibility. Pharmacies rely on this information to 
ensure that payments for beneficiaries filling their prescriptions are 
processed appropriately. During the enrollment process, beneficiaries 
choose one of three options for paying their share of their Part D 
premiums--direct billing, automated withdrawal from financial accounts, 
or automatic deductions from social security payments, called premium 
withholds. As of January 2008 about 20 percent of Part D enrollees--4.8 
million beneficiaries--opted to have premiums withheld from their 
social security payments, which requires coordination among plan 
sponsors, CMS, and SSA. When a beneficiary elects this option, CMS 
provides enrollment and payment information it receives from plan 
sponsors to SSA for processing. SSA then deducts premium amounts from 
beneficiaries' monthly social security payments and provides CMS with 
information on the amount of premiums it deducted in order for CMS to 
pay the appropriate plan sponsors. 

Part D Complaints and Grievances Processes: 

Beneficiaries can express dissatisfaction with any aspect of the Part D 
program, other than coverage determinations, by filing a complaint with 
CMS or filing a grievance directly with their respective plan sponsors 
(see fig. 1).[Footnote 18] The processes for resolving complaints and 
grievances are independent of one another and the status of individual 
complaints and grievances is tracked separately. Although CMS 
encourages beneficiaries to first file a grievance with their 
respective plan sponsors, a beneficiary can choose to seek resolution 
by directly contacting CMS first to file a complaint or by filing a 
complaint and grievance simultaneously. 

Figure 1: Part D Complaints and Grievances Processes: 

[See PDF for image] 

This figure is an illustration of the Part D complaints and grievances 
processes. There are three avenues illustrated, as follows: 

(1) Beneficiary files complaint, grievance, or both: 
* 1-800-Medicare call center; problem is called a "complaint;"
* Part D Complaints Tracking Module (CTM); 
* Part D Sponsors; 
* Complaint Resolution: 
- Immediate need: within 2 calendar days; 
- Urgent: within 10 calendar days; 
- Routine: within 30 calendar days. 

(2) Beneficiary files complaint, grievance, or both: 
* CMS Regional Office; problem is called a "complaint;" 
* Part D Complaints Tracking Module (CTM); 
* CMS Regional Office; 
* Complaint Resolution: 
- Immediate need: within 2 calendar days; 
- Urgent: within 10 calendar days; 
- Routine: within 30 calendar days. 

(3) Beneficiary files complaint, grievance, or both: 
* Plan Sponsor; problem is called a "grievance;" 
* Grievance Process: Each plan has its own unique system for processing 
grievances; 
* Grievance Resolution: Generally within 30 days. 

Source: GAO, Art Explosion (graphics). 

[End of figure] 

Beneficiaries typically file complaints by calling CMS's 1-800-Medicare 
toll-free number or by contacting one of CMS's 10 regional offices 
through telephone, fax, mail, or e-mail.[Footnote 19] For complaints 
filed through the toll-free number, customer service representatives 
(CSRs) enter details about the complaints into the 1-800-Medicare 
database, and assign the complaint to specific contracts administered 
by plan sponsors. CSRs also categorize the complaint in several ways, 
including by (a) the nature of the complaint using 20 categories and 
over 180 subcategories, such as whether the complaint relates to 
enrollment, pricing, or customer service; and (b) the complaint's issue 
level or level of urgency, which corresponds to one of three issue 
levels---immediate need, urgent, or routine--depending on the 
beneficiary's risk of exhausting his or her medication supply while 
resolution of the complaint is pending. 

The information included in the 1-800-Medicare database is uploaded 
each day into the CTM--CMS's centralized database of complaints 
information.[Footnote 20] For complaints filed with the CMS regional 
offices, regional staff similarly categorize complaints by their nature 
and issue level and input them directly into the CTM. Most complaints 
in the CTM are assigned to specific contracts administered by plan 
sponsors who utilize their own staff to resolve beneficiaries' 
concerns.[Footnote 21] For complaints beyond the control of plan 
sponsors, such as those involving premium withholding and certain 
enrollment issues, plan sponsors request, through the CTM, that CMS 
resolve the complaint. Once complaints are resolved, the resolution 
date must be entered into the CTM. CMS requires that immediate need 
complaints be resolved within 2 calendar days, and encourages that 
urgent and routine complaints be resolved within 10 and 30 calendar 
days respectively.[Footnote 22] According to CMS policy, beneficiaries 
should be notified once their complaints are resolved. 

Beneficiaries also have the right to express dissatisfaction by filing 
a grievance directly with their plan sponsors via telephone, fax, mail, 
or e-mail.[Footnote 23] Plan sponsors enter information about the 
grievances in their internal tracking systems and assign individual 
grievances to their staff, who work to resolve them. Plan sponsors are 
required to resolve grievances within 30 days, but can allow for a 14- 
day extension in some cases.[Footnote 24] Plan sponsors must inform 
beneficiaries of the outcome of the grievances process, and 
beneficiaries who are dissatisfied may choose to file a complaint with 
CMS on the same issue. 

CMS Oversight of the Part D Complaints and Grievances Processes: 

CMS is responsible for overseeing the Part D program, which includes 
overseeing the complaints and grievances processes and ensuring that 
beneficiaries' problems are addressed. To oversee the complaints 
process, CMS staff monitor data within the CTM, including calculating 
complaint rates and resolution times for each Part D contract 
administered by a plan sponsor. Specifically, CMS monitors resolution 
time frames to determine whether plan sponsors resolve complaints 
assigned to their contracts within applicable time frames. To aid its 
oversight of the grievances process, CMS requires plan sponsors to 
categorize grievances into 1 of 11 categories,[Footnote 25] which 
differ from CTM categories, and submit quarterly reports for each of 
their contracts on the number of grievances by category[Footnote 26] 
(see app. I). CMS uses these data to calculate grievance rates to 
identify plan sponsors with outlier contracts. 

According to CMS officials, the agency can initiate a range of actions 
against plan sponsors it determines have noncompliant processes (see 
fig. 2). For example, CMS can make a formal compliance call to plan 
sponsors to discuss identified issues. However, if CMS's monitoring 
indicates that plan sponsors are not taking corrective actions in 
response to the compliance call, CMS may pursue more stringent 
compliance actions.[Footnote 27] For example, the agency may send 
formal written notices of noncompliance, which notify plan sponsors of 
their noncompliance and explicitly inform them that they must address 
the problems. For plan sponsors that remain noncompliant, CMS can send 
warning letters that notify plan sponsors that their performance is 
unacceptable; request that plan sponsors submit written corrective 
action plans that show formal plans to come into compliance; or audit 
the plan sponsors.[Footnote 28] In the most extreme cases of 
noncompliance, CMS can impose intermediate sanctions, which include 
suspension of enrollment, payment, or marketing activities. CMS can 
also impose a civil monetary penalty or terminate or decline to renew a 
Part D contract. 

Figure 2: Range of Actions to Address Noncompliance in Order of 
Severity: 

[See PDF for image] 

This figure is an illustration of the range of actions to address 
noncompliance in order of severity, as follows: 

Actions are listed from least severe to most severe: 
* Formal compliance call; 
* Formal written notice of noncompliance; 
* Warning letter; 
* Request for written corrective action plan; 
* Audit; 
* Sanctions (i.e., suspension of enrollment), civil monetary penalty, 
or contract termination. 

Source: CMS. 

[End of figure] 

Complaints Data Highlight Beneficiaries' Enrollment Problems, Decline 
in Complaint Rates, and Ongoing Challenges: 

Most complaints related to enrollment issues and while both the number 
of complaints and the time needed to resolve them decreased as the Part 
D program matured, ongoing challenges continued to pose problems for 
some beneficiaries. The majority of complaints were related to delays 
and errors in processing beneficiaries' enrollment and disenrollment 
requests and were resolved. In addition, a small proportion of 
complaints involved cases where beneficiaries were at risk of depleting 
their medication supplies. Further, trends in complaints data suggest 
that beneficiaries reported fewer complaints over time and their 
problems were resolved more quickly as they, plan sponsors, and CMS 
gained experience with the Part D benefit. However, the complaints data 
also revealed some ongoing challenges facing the program, including 
problems related to data system coordination between CMS and plan 
sponsors and between CMS and SSA, which continued to present 
difficulties for some beneficiaries. 

Most Complaints Were Related to Enrollment Issues and Were Resolved: 

During the 18-month period from May 1, 2006, through October 31, 2007, 
629,792 complaints were filed with CMS--an average monthly complaint 
rate of 1.5 complaints per 1,000 beneficiaries.[Footnote 29] The 
majority of complaints--about 63 percent--were related to problems 
beneficiaries experienced when trying to enroll in or disenroll from a 
plan, and about 21 percent were related to pricing and coinsurance 
issues. The remaining 15 percent of complaints were spread among the 
other 18 CTM categories, and included complaints related to customer 
service and marketing of plans (see fig. 3). 

Figure 3: Proportion of Medicare Part D Complaints Filed by CTM 
Category, May 2006-October 2007: 

[See PDF for image] 

This figure is a pie-chart depicting the following data: 

Proportion of Medicare Part D Complaints Filed by CTM Category: 
Enrollment/disenrollment: 63% (399,402); 
Pricing/coinsurance: 21% (133,318); 
All others: 15% (97,034). 

Source: GAO analysis of CTM complaints. 

Note: 38 of the 629,792 complaints were not assigned to a CTM category. 

Percentages may not sum to 100 because of rounding. 

[End of figure] 

The vast majority--about 73 percent of the enrollment and disenrollment 
complaints, or 290,000 complaints--were assigned to five CTM 
subcategories and were related to delays and errors in processing 
beneficiaries' enrollment or disenrollment requests.[Footnote 30] 
According to CMS officials, such problems occurred when enrollment 
records between CMS and plan sponsors differed or contained errors, and 
thus extra time was needed for CMS and plan sponsors to identify and 
correct the errors and ensure beneficiaries were enrolled in their 
plans of choice. 

Approximately 47,000 (or more than 35 percent) of the complaints that 
were categorized as pricing and coinsurance issues were related to 
beneficiaries who experienced problems having their premiums 
automatically deducted from their social security payments.[Footnote 
31] Specifically, these complaints included cases in which the wrong 
amounts were deducted from beneficiaries' social security payments, the 
correct amounts were being deducted but were not forwarded to the 
appropriate plan sponsor for payment, or premiums had not yet been 
deducted when beneficiaries expected otherwise.[Footnote 32] According 
to CMS officials, many of the complaints related to accurately 
deducting premiums and forwarding payments to plan sponsors were due to 
problems with data exchanges between CMS and SSA. In addition, CMS 
officials indicated that beneficiaries are not always aware that it can 
take several months for SSA to process a request for premium 
deductions; therefore, they may file complaints when premiums are not 
immediately deducted from their social security payments. Many of the 
remaining pricing and coinsurance complaints were filed because some 
beneficiaries complained they were charged too high of a coinsurance 
amount for their prescriptions. 

In addition to complaint categories, the CTM also contains information 
on the "issue level" of complaints (immediate need, urgent, routine), 
and the dates complaints were filed and resolved. We found that about 
73 percent of complaints were unrelated to beneficiaries at risk of 
depleting their supplies of medication and were considered routine. 
About 20 percent of complaints were considered immediate need, meaning 
beneficiaries had between 0 and 2 days of medication remaining, and 
about 7 percent of complaints were considered urgent, meaning 
beneficiaries had 3 to 14 days of medication remaining. Further, using 
CTM dates, we found that 99 percent of all complaints filed between May 
2006 and October 2007 were resolved, on average, in 25 days.[Footnote 
33] Although immediate need and urgent complaints were resolved, on 
average, much more quickly--12 days for immediate need complaints and 
16 days for urgent complaints--these average resolution times still 
exceeded CMS's resolution time frames.[Footnote 34] 

Finally, we found that 44 percent of all complaints involved issues, 
such as those related to premium deductions from social security 
payments, which were beyond the control of plan sponsors, and thus 
required CMS intervention for resolution.[Footnote 35] When compared to 
complaints that plan sponsors could resolve independently, these 
complaints took, on average, twice as long--34 days compared to 17 
days----to resolve. According to CMS officials, the lengthier 
resolution times for complaints requiring CMS intervention reflected 
the fact that these complaints were often related to delays associated 
with reconciling data between the agency and plan sponsors or SSA. 

Trends in Complaints Data Indicate Beneficiaries Reported Fewer 
Problems, but Highlight Ongoing Challenges: 

Trends in the complaints data indicate that beneficiaries reported 
fewer problems and their problems were resolved more quickly. For 
example, while the average monthly complaint rate was 1.5 per 1,000 
beneficiaries during the period, the monthly complaint rate declined by 
74 percent from its peak of 2.86 complaints per 1,000 beneficiaries in 
May 2006 to .73 in October 2007 (see fig. 4). 

Figure 4: Medicare Part D Complaint Rates per 1,000 Beneficiaries, May 
2006-October 2007: 

[See PDF for image] 

This figure is a line graph depicting the following data: 

Month filed: May 2006; 	
Complaint rate per 1,000 beneficiaries: 2.86. 

Month filed: June 2006; 
Complaint rate per 1,000 beneficiaries: 2.84. 

Month filed: July 2006; 
Complaint rate per 1,000 beneficiaries: 2.36. 

Month filed: August 2006; 
Complaint rate per 1,000 beneficiaries: 2.24. 

Month filed: September 2006; 
Complaint rate per 1,000 beneficiaries: 1.63. 

Month filed: October 2006; 
Complaint rate per 1,000 beneficiaries: 1.41. 

Month filed: November 2006; 
Complaint rate per 1,000 beneficiaries: 1.08. 

Month filed: December 2006; 
Complaint rate per 1,000 beneficiaries: 0.72. 

Month filed: January 2007; 
Complaint rate per 1,000 beneficiaries: 1.4. 

Month filed: February 2007; 
Complaint rate per 1,000 beneficiaries: 1.36. 

Month filed: March 2007; 
Complaint rate per 1,000 beneficiaries: 1.54. 

Month filed: April 2007; 
Complaint rate per 1,000 beneficiaries: 1.57. 

Month filed: May 2007; 
Complaint rate per 1,000 beneficiaries: 1.5. 

Month filed: June 2007; 
Complaint rate per 1,000 beneficiaries: 1.12. 

Month filed: July 2007; 
Complaint rate per 1,000 beneficiaries: 1. 

Month filed: August 2007; 
Complaint rate per 1,000 beneficiaries: 1.04. 

Month filed: September 2007; 
Complaint rate per 1,000 beneficiaries: 0.83. 

Month filed: October 2007; 
Complaint rate per 1,000 beneficiaries: 0.73. 

There was an overall decline of 74% during the period of May 2006 to 
October 2007. 

Source: GAO analysis of CTM data. 

[End of figure] 

In addition, the average time needed to resolve beneficiaries' 
complaints declined by 73 percent, from a peak of 33 days in July 2006 
to 9 days in October 2007 (see fig. 5). The decline in average 
resolution time for complaints CMS resolved during this period was even 
more pronounced, falling from 51 days to 11 days. According to CMS 
officials, the decline in monthly complaint rates and average 
resolution times reflected improved implementation of the Part D 
program since the initial election period, and improved familiarity of 
the program among beneficiaries, plan sponsors, and CMS itself. 

Figure 5: Average Resolution Times for Closed Complaints, May 2006- 
October 2007: 

[See PDF for image] 

This figure is a multiple line graph depicting the following data: 

Month filed: May 2006; 
Complaints requiring CMS resolution: 20.59; 
Average of all complaints: 24.35. 

Month filed: June 2006; 
Complaints requiring CMS resolution: 43.64; 
Average of all complaints: 26.31. 

Month filed: July 2006; 
Complaints requiring CMS resolution: 51.25; 
Average of all complaints: 32.53. 

Month filed: August 2006; 
Complaints requiring CMS resolution: 50.5; 
Average of all complaints: 30.22. 

Month filed: September 2006; 
Complaints requiring CMS resolution: 48.26; 
Average of all complaints: 30.17. 

Month filed: October 2006; 
Complaints requiring CMS resolution: 40; 
Average of all complaints: 25.05. 

Month filed: November 2006; 
Complaints requiring CMS resolution: 37.48; 
Average of all complaints: 23.6. 

Month filed: December 2006; 
Complaints requiring CMS resolution: 36.74; 
Average of all complaints: 24.01. 

Month filed: January 2007; 
Complaints requiring CMS resolution: 35; 
Average of all complaints: 19.83. 

Month filed: February 2007; 
Complaints requiring CMS resolution: 32.71; 
Average of all complaints: 21.61. 

Month filed: March 2007; 
Complaints requiring CMS resolution: 34.89; 
Average of all complaints: 25.65. 

Month filed: April 2007; 
Complaints requiring CMS resolution: 35.17; 
Average of all complaints: 26.85. 

Month filed: May 2007; 
Complaints requiring CMS resolution: 32.58; 
Average of all complaints: 24.4. 

Month filed: June 2007; 
Complaints requiring CMS resolution: 30.98; 
Average of all complaints: 23.35. 

Month filed: July 2007; 
Complaints requiring CMS resolution: 22.39; 
Average of all complaints: 17.75. 

Month filed: August 2007; 
Complaints requiring CMS resolution: 18.49; 
Average of all complaints: 15.06. 

Month filed: September 2007; 
Complaints requiring CMS resolution: 15.89; 
Average of all complaints: 12.93. 

Month filed: October 2007; 
Complaints requiring CMS resolution: 10.78; 
Average of all complaints: 9.12. 

There was an average decline of 73% during the period of July 2006 to 
October 2007. 

Note: Based on the 600,382 closed complaints with valid resolution 
dates over the period. 

[End of figure] 

While trends in the complaints data highlighted declines in the monthly 
complaint rate and average resolution times, they also revealed some 
ongoing challenges facing the program. Specifically, the data confirmed 
information-processing issues related to beneficiaries' requests for 
enrollment changes and automatic premium withholds from their Social 
Security payments remained. For example, despite the trend in the 
overall complaint rate discussed earlier and as shown in figure 4, the 
complaint rate nearly doubled, from .72 in December 2006 to 1.40 in 
January 2007. This was due largely to a spike in the number of 
complaints related to delays or errors when CMS and plan sponsors 
processed beneficiaries' enrollment and disenrollment requests 
following the end of the 2007 annual coordinated election period. 
[Footnote 36] More specifically, according to CMS officials this 
increased complaint rate was due largely to the sheer volume of 
transactions processed during this time each year. The officials told 
us that while they expect to continue to see an increase in complaints 
each year following the annual coordinated election period, they expect 
the magnitude of such increases to diminish as the program matures. 

In addition, the general trend of increasing complaint rates from 
January 2007 through May 2007 reflected increasing numbers of 
complaints related to beneficiaries' requests for automatic withholding 
of premiums that can occur when beneficiaries elect to change plans. 
According to CMS officials, the timing of when SSA processes the 
premium withhold request may affect the accuracy of the deduction, and 
result in complaints. For example, as required by law, SSA must process 
cost-of-living adjustments for beneficiaries' social security payments 
on an annual basis, and according to SSA, they begin this processing in 
November of each year. To process these adjustments for recipients who 
are also enrolled in Part D and have chosen the premium withholding 
option, SSA must rely on CMS enrollment information to determine the 
amount to deduct for Part D premiums. However, because beneficiaries 
may have elected to change plans during the Part D annual coordinated 
election period, which runs from November 15 through December 31 of 
each year, SSA's calculations may not account for premium differences 
related to beneficiaries' subsequent enrollment changes.[Footnote 37] 
CMS officials indicated that there is no easy solution to the data 
coordination and timing issues between CMS and SSA at the root of this 
problem. However, CMS and SSA have formed several work groups to 
identify improvements, including improved data system exchanges, which 
could help reduce complaints related to this issue. In the interim, CMS 
has undertaken outreach efforts to plan sponsors and beneficiaries to 
inform them of potential delays related to requests for automatic 
premium withholds, letting them know that such requests may take 
several months to process. 

Finally, while we found that CMS and plan sponsors resolved complaints, 
including immediate need and urgent complaints, more quickly as the 
Part D program matured, a substantial percentage of such complaints 
were not resolved within CMS's time frames. Specifically, during the 
period from May 2006 through October 2007, 53 percent of immediate need 
complaints (66,001) and 27 percent of urgent need complaints (10,476) 
were not resolved within the applicable time frames. Further, progress 
in meeting the time frames, particularly for immediate need cases, 
largely stagnated from March 2007 to October 2007, as the proportion of 
cases not meeting the time frame hovered around 30 percent each month 
(see fig. 6). 

Figure 6: Proportion of Immediate Need and Urgent Cases Closed but Not 
Meeting Time Frames: 

[See PDF for image] 

This figure is a multiple vertical bar graph depicting the following 
data: 

Proportion of Immediate Need and Urgent Cases Closed but Not Meeting 
Time Frames: 

Month filed: May 2006; 
Immediate need: 64.59%; 
Urgent: 31.96%. 

Month filed: June 2006; 
Immediate need: 74.65%; 
Urgent: 41.74%. 

Month filed: July 2006; 
Immediate need: 75.83%; 
Urgent: 42.12%. 

Month filed: August 2006; 
Immediate need: 62.27%; 
Urgent: 30.14%. 

Month filed: September 2006; 
Immediate need: 50.95%; 
Urgent: 25.27%. 

Month filed: October 2006; 
Immediate need: 49.11%; 
Urgent: 24.35%. 

Month filed: November 2006; 
Immediate need: 41.46%; 
Urgent: 17.47%. 

Month filed: December 2006; 
Immediate need: 35.83%; 
Urgent: 17.9%. 

Month filed: January 2007; 
Immediate need: 31.5%; 
Urgent: 16.52%. 

Month filed: February 2007; 
Immediate need: 36.84%; 
Urgent: 17.9%. 

Month filed: March 2007; 
Immediate need: 29.61%; 
Urgent: 20.5%. 

Month filed: April 2007; 
Immediate need: 30.62%; 
Urgent: 25.75%. 

Month filed: May 2007; 
Immediate need: 32.43%; 
Urgent: 18.9%. 

Month filed: June 2007; 
Immediate need: 32.82%; 
Urgent: 20.68%. 

Month filed: July 2007; 
Immediate need: 32.64%; 
Urgent: 20.85%. 

Month filed: August 2007; 
Immediate need: 31.62%; 
Urgent: 18%. 

Month filed: September 2007; 
Immediate need: 33.15%; 
Urgent: 16.48%. 

Month filed: October 2007; 
Immediate need: 31.45%; 
Urgent: 14.93%. 

Source: GAO analysis of CTM complaints. 

[End of figure] 

Limitations in Grievances Data Reported by Plan Sponsors for Their 
Contracts Prevent Reliable Assessment of Beneficiaries' Experiences 
with Part D: 

Grievances data reported by plan sponsors for their contracts contained 
limitations and anomalies and did not yield sufficient insight into 
beneficiaries' experiences with Part D. In contrast to the data CMS 
collects on complaints, CMS only requires plan sponsors to submit 
quarterly reports on the total number of grievances they received in 11 
CMS-defined categories for each of their Part D contracts. Therefore, 
CMS does not have information about whether a grievance is related to a 
beneficiary's medication supply or whether it was ultimately resolved. 
As a result, we were unable to determine the extent to which 
beneficiaries' grievances related to medication supply issues, the 
extent to which plan sponsors were resolving grievances, or whether 
they were resolving them in a timely manner. 

In addition to their limited nature, we identified a number of 
anomalies in the grievances data that raise questions about their 
accuracy and usefulness in drawing conclusions about beneficiaries' 
experiences with Part D. Among these anomalies, we found that 
grievances were concentrated in a small number of contracts, and at a 
rate that was significantly disproportionate to their respective 
enrollments, raising questions about whether plan sponsors were 
reporting grievances data for their contracts in a comprehensive and 
consistent manner. For example, in 2006 plan sponsors reported 
grievances data for 522 contracts, 19 of which accounted for 80 percent 
of all grievances but only 49 percent of enrollment. The concentration 
was more pronounced in 2007, when 11 of the 604 contracts for which 
grievances data were reported accounted for 90 percent of all 
grievances but only 42 percent of enrollment.[Footnote 38] 

We also found significant variations in the number of grievances 
reported for contracts with similar levels of enrollment, and in the 
number of grievances filed between 2006 and 2007. For example, in 2006, 
while the two largest contracts each averaged about 3 million 
enrollees, one contract had more than 140,000 grievances, for an 
average monthly grievance rate of 4.22 per 1,000 beneficiaries, while 
the other contract had fewer than 4,000 grievances, for a grievance 
rate of .11 per 1,000 beneficiaries. In addition, in contrast to the 
decline in the monthly complaint rate that we identified, available 
data show an increase in the average monthly grievance rate between 
2006 and 2007. Specifically, while a total of 310,215 grievances were 
reported in 2006, for an average monthly grievance rate of 1.23 per 
1,000 beneficiaries, there were a total of 726,440 grievances reported 
for the first 3 quarters of 2007 alone, for a rate of 3.38 per 1,000 
beneficiaries. We found that this variation was predominately due to 
differences in the number of grievances reported for three contracts, 
which had a total of 70 grievances for 2006, and 495,961 for the first 
3 quarters of 2007, despite having nearly identical levels of total 
enrollment in each year. 

Finally, the proportion of grievances assigned to categories varied 
significantly between 2006 and 2007, a change that is inconsistent with 
trends in the complaints data. For example, while over 60 percent of 
the 2006 grievances were assigned to the enrollment and disenrollment 
category--a percentage generally similar to the complaints data filed 
with CMS--they assigned approximately 5 percent of the 2007 grievances 
to this category. In commenting on a draft of this report, CMS 
indicated that the variation between the two years was likely due to 
data collection issues that existed during the early implementation of 
Part D. For example, CMS suggested that the grievances data reported by 
plan sponsors in 2006 included nongrievances or erroneously categorized 
grievances in the enrollment and disenrollment category. 

CMS's Oversight Focused on Complaints and Not Grievances, Leaving 
Oversight Gaps: 

While CMS has a systematic oversight process for complaints, it lacks a 
similar oversight framework for plan sponsor-reported grievance 
processes. To oversee the complaints process, CMS has established a 
framework consisting of several key elements, which include standard 
operating policies and procedures and a centralized repository of 
complaints data, and staff that routinely review and assess the 
complaints data and take actions against plan sponsors it determines 
have noncompliant processes. In contrast to complaints, CMS's oversight 
of plan sponsors' grievances processes has been more limited. CMS 
developed guidance for classifying grievances, required plan sponsors 
to report summary grievances data for each of their Part D contracts, 
and periodically reviewed these data. However, limitations in these 
oversight elements have resulted in plan sponsors reporting incomplete 
and inconsistent data to CMS, and there is little assurance that 
beneficiaries' grievances are resolved or that they are resolved in a 
consistent fashion. 

To ensure a level of consistency in how complaints are tracked and 
resolved, CMS developed standard operating procedures for both its 
caseworkers and plan sponsors. These procedures provide guidance on how 
complaints should be entered into the CTM as well as how caseworkers 
and plan sponsors should resolve them. For example, CMS's guidance 
includes requirements to enter key dates for each complaint, such as 
the dates complaints were filed and resolved, and information about how 
individual complaints should be categorized by their nature and issue 
level.[Footnote 39] Specifically, CMS's guidance to plan sponsors 
provides information about how they can utilize the CTM to access, 
review, and document case resolution, or request CMS assistance in the 
event they are unable to achieve resolution. Through its guidance, CMS 
has been able to ensure consistency in terms of the information the CTM 
contains about each complaint. Further, it has allowed the agency to 
create, through the CTM, a reliable source of data from which it can 
monitor the complaints process. 

CMS also dedicated significant resources to ensure that beneficiaries' 
complaints are addressed. Specifically, CMS officials estimated that 
several hundred staff members throughout the agency have some 
responsibility for the oversight of the complaints process.[Footnote 
40] For example, some regional staff members are responsible for 
reviewing plan sponsors' case notes included in the CTM to verify their 
resolution of complaints or for directly resolving complaints beyond 
the control of plan sponsors. In addition, other CMS staff members 
routinely analyze CTM data to identify trends in complaint rates and 
track issues related to the performance of individual plan sponsors, 
such as resolution times. For example, on a quarterly basis, CMS staff 
members analyze complaint rates for individual contracts both by 
overall complaints and by three CTM categories, and then compare 
complaint rates among contracts.[Footnote 41] Based on this comparison, 
CMS staff assign a star rating to each contract.[Footnote 42] Further, 
CMS has dedicated staff in the Office of the Medicare Beneficiary 
Ombudsman (OMO) who utilize complaints data to identify systemic 
problems affecting the implementation of Part D.[Footnote 43] When OMO 
staff identify problems, such as those related to delays in processing 
enrollment requests and withholding premiums from Social Security 
payments, they alert high-level CMS managers, who in turn are 
responsible for initiating corrective actions. 

CMS officials informed us that the agency may rely on a variety of 
actions, ranging from formal compliance calls to the termination of a 
plan sponsor's Part D contract when it identifies a plan sponsor that 
is noncompliant with requirements for the complaints process. CMS 
officials indicated that their use of such actions has been limited 
because informal conference calls with plan sponsors have frequently 
been sufficient to correct problems identified through complaints. For 
example, although CMS officials said that they would require plan 
sponsors with contracts that received a one or two star rating for 2 
consecutive quarters to submit a business plan describing how they 
would improve their performance, they have never had to do so because 
their informal calls to such plan sponsors have thus far been 
sufficient to correct problems. However, in some cases, CMS has taken 
more stringent actions.[Footnote 44] For example, as of February 2008, 
CMS had issued 144 notices of noncompliance and 22 warning letters, and 
initiated 3 audits against plan sponsors that did not meet their 
contractual performance requirement to resolve 95 percent of immediate 
need complaints within 2 days.[Footnote 45],[Footnote 46] Additionally, 
CMS had not terminated any plan sponsors' Part D contract or levied 
civil monetary penalties in response to issues related to compliance 
with the complaints process. 

While CMS has a framework in place for overseeing the complaints 
process, some opportunities for improvement exist. For example, despite 
the existence of CMS's performance requirement, plan sponsors and CMS 
itself failed to resolve a substantial number of immediate need 
complaints within 2 days. As a result, some beneficiaries might have 
exhausted their medication supplies while waiting for their complaints 
to be resolved. While CMS officials indicated that they expected 
pharmacists to provide a temporary medication supply to affected 
beneficiaries until their complaints were resolved, they acknowledged 
that no specific policy exists to ensure that all beneficiaries receive 
or continue to receive their medication.[Footnote 47] CMS also does not 
have a mechanism to verify that plan sponsors have effectively resolved 
complaints. While CMS caseworkers review plan sponsors' notes in the 
CTM, they do not routinely take a sample of complaints and follow up 
with beneficiaries to validate the plan sponsors' resolution actions. 
CMS officials indicated that the agency does not have the resources to 
perform such a comprehensive check and stated that beneficiaries who 
are dissatisfied with their plan sponsor's resolution could file 
another complaint directly with CMS. 

In contrast to complaints, CMS's oversight of plan sponsor grievances 
processes has been more limited. CMS provided plan sponsors with 
general guidance for determining whether beneficiaries' problems were 
grievances or coverage determinations, which are addressed through a 
separate process. CMS also provided plan sponsors with time frames for 
resolving grievances, periodically reviewed plan sponsor grievances 
data, and began auditing plan sponsors' grievances processes in 2007. 
[Footnote 48] However, although CMS's guidance to plan sponsors 
included examples of how they could classify beneficiaries' problems, 
several plan sponsors we interviewed said that this guidance was not 
detailed enough and raised concerns about whether plan sponsors were 
accurately differentiating among inquiries (i.e., general questions 
about the Part D program), grievances, or coverage determinations. CMS 
officials acknowledged that some plan sponsors have incorrectly 
classified inquiries as grievances. Further, in its 2007 audits of plan 
sponsors' grievances processes, CMS found numerous cases where plan 
sponsors did not correctly differentiate between grievances and 
coverage determinations, supporting plan sponsors' concerns about the 
adequacy of the existing guidance. Such confusion about how to classify 
grievances increases the likelihood that plan sponsors report erroneous 
or inconsistent information to CMS and that they rely on the wrong 
processes to address beneficiaries' concerns. 

CMS does not require plan sponsors to report certain information on 
grievances for each of their Part D contracts, such as resolution 
dates, that is essential for determining whether beneficiaries' 
grievances are being resolved, and devotes few resources to reviewing 
what plan sponsors have reported for their contracts. Instead, on a 
quarterly basis, each plan sponsor reports the total number of 
grievances for 11 categories for each of its contracts. CMS officials 
also could not explain many of the anomalies we identified in the 
grievances data, such as substantial variation in the enrollment 
category from 2006 to 2007 and considerable variation in the grievance 
rates between contracts with similar levels of enrollment. Further, 
they acknowledged that they had not undertaken efforts to review the 
data in detail or to assess their overall reliability. In fact, more 
than a year into the program, CMS officials were still uncertain as to 
whether grievances had been reported for all contracts, and as of May 
2008, agency analysis was limited to calculating annual grievance rates 
for each contract that did report grievances.[Footnote 49] 

CMS officials recognized that their efforts to oversee the grievances 
process have been limited, as they have chosen to focus their attention 
on other oversight issues such as appeals and coverage determinations 
and have devoted resources to program implementation issues, such as 
enrollment of dual-eligible beneficiaries. In the event that plan 
sponsors are not properly responding to beneficiaries' grievances, CMS 
officials stated that the issues could be resolved through the 
complaints process. Therefore, by focusing its attention largely on 
complaints, the agency expressed confidence that plan sponsors are 
addressing beneficiaries' issues. While the agency strongly believes in 
providing plan sponsors the latitude to implement their individual 
grievances processes, CMS expects to devote more resources to the 
oversight of grievances processes as the program matures. 

Conclusions: 

January 1, 2006, marked a new era in the Medicare program as the 
federal government began offering outpatient prescription drug coverage 
to eligible Medicare beneficiaries. The program is currently in its 
third year of operation, and millions of individuals have chosen to 
enroll. While trends in complaints data suggest that CMS and plan 
sponsors have improved program operations over time, lingering 
operational issues continue to pose challenges to some beneficiaries. 
This has hindered their ability to enroll in their plans of choice, 
have their premiums accurately deducted from their social security 
payments, or ensure that their problems related to critical medication 
supply issues are resolved in a timely manner. While CMS is taking 
action to address some of these operational issues related to 
complaints, its continued effort to address these operational 
challenges will be key to achieving further improvement. Furthermore, 
CMS does not have reliable grievances data to identify problems and 
needed improvements and ultimately ensure that beneficiaries' concerns 
are addressed. This is particularly important given that CMS encourages 
beneficiaries to utilize the grievances process as their first line of 
redress when trying to resolve problems. Without reliable grievances 
data, CMS cannot ensure that plan sponsors are fulfilling their 
obligations and provide a full assessment of beneficiaries' experiences 
with the program. 

Recommendations: 

To improve oversight of the Medicare Part D grievances process, and 
provide added assurance that beneficiaries' grievances are being 
resolved, we recommend that CMS undertake efforts to improve the 
consistency, reliability, and usefulness of grievances data reported by 
plan sponsors for each of their contracts. Such efforts include 
enhancing its existing guidance for determining whether beneficiaries' 
problems are grievances, requiring plan sponsors to report information 
regarding the status and issue level of grievances, and conducting 
systematic oversight of these data. 

Agency Comments: 

We provided a draft of this report for comment to the Administrator of 
CMS. In its written comments (see app. II.), CMS remarked that our 
report did an "impressive job" describing the complex processes 
employed to monitor complaints and grievances regarding Medicare Part 
D. The agency concurred with the report's recommendation to undertake 
efforts to improve the consistency, reliability, and usefulness of 
grievances data reported by plan sponsors for each of their contracts, 
and highlighted steps it already has taken to implement it. CMS took 
issue with the report's conclusion that its oversight activities were 
focused almost exclusively on resolving complaints with little 
attention devoted to plan sponsors' grievances processes, and noted 
that it felt some information, such as details concerning attestations 
made as part of sponsors' Part D applications, had been omitted from 
our report. In addition to these comments, CMS provided detailed, 
technical comments that we incorporated as appropriate. 

Consistent with the recommendation to improve the consistency, 
reliability, and usefulness of grievances data, CMS noted that it has 
been working to provide Part D sponsors with more comprehensive 
guidance, enhance its oversight activities, and undertake corrective 
actions as needed. CMS stated that it recently provided guidance to 
plan sponsors regarding statutory definitions of grievances, coverage 
determinations, and appeals to facilitate accurate reporting of these 
data to CMS. For example, CMS cited its 2008 Reporting Requirements 
Technical Specifications, released this spring, as part of its efforts 
to further educate plan sponsors about the differences between coverage 
determinations and grievances. CMS further stated that it would 
consider adding data elements related to plan sponsors' timeliness and 
quality of grievances resolution to its calendar year 2010 Reporting 
Requirements. 

CMS took issue with the report's conclusion that its oversight 
activities were focused almost exclusively on resolving complaints with 
little attention devoted to plan sponsors' grievances processes. The 
agency noted that it considered this conclusion misleading and felt it 
did not appropriately weigh all components of CMS's oversight of plan 
sponsors' grievances processes, such as plan sponsor audits, which 
include a review of grievances processes. In addition, CMS noted that 
the report did not consider a component of the Part D application, in 
which sponsors must attest that they will establish and maintain 
grievances processes in accordance with federal regulations. Finally, 
while agreeing with the report's statement that the average resolution 
time for immediate need and urgent complaints exceeded CMS's required 
time frames, CMS noted that its analysis of more recent complaints data 
demonstrated that case resolution time frames had improved and were 
trending towards CMS's standard time frames. 

We recognize that CMS has audited the grievances processes of some plan 
sponsors, and the report highlighted key findings from these audits. 
While we believe CMS can rely on such audits to improve its oversight 
in the future, the agency did not begin auditing plan sponsors until 
2007, and has yet to audit a number of plan sponsors. Further, while we 
recognize the attestation component of the application requirement, we 
believe that such attestations provide only limited assurance that 
beneficiaries' grievances are being resolved appropriately. We do not 
believe CMS will be able to ensure that plan sponsors are abiding by 
their statements until CMS audits the grievances processes of all plan 
sponsors. Finally, we did not evaluate CMS's findings on resolution 
time frames from its more recent data, because the data CMS used to 
conduct their analyses of resolution time frames were from a time frame 
beyond the scope of our work. 

As agreed with your office, unless you publicly announce its contents 
earlier, we plan no further distribution of this report until 30 days 
after its issue date. At that time, we will send copies to the 
Secretary of Health and Human Services and other interested parties. We 
will also make copies available to others upon request. In addition, 
this report will be available at no charge on GAO's Web site at 
[hyperlink, http://www.gao.gov]. 

If you or your staff have any questions about this report, please 
contact Kathleen King at (202) 512-7114 or kingk@gao.gov. Contact 
points for our Offices of Congressional Relations and Public Affairs 
may be found on the last page of this report. Susan Anthony, Assistant 
Director; Jennie Apter; Shirin Hormozi; David Lichtenfeld; and Jennifer 
Whitworth made key contributions to this report. 

Signed by: 

Kathleen M. King: 
Director, Health Care: 

List of Requesters: 

The Honorable John D. Dingell: 
Chairman: 
Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Henry A. Waxman: 
Chairman: 
Committee on Oversight and Government Reform: 
House of Representatives: 

The Honorable Charles B. Rangel: 
Chairman: 
Committee on Ways and Means: 
House of Representatives: 

The Honorable Pete Stark: 
Chairman: 
Subcommittee on Health Committee on Ways and Means: 
House of Representatives: 

The Honorable Frank Pallone, Jr. 
Chairman: 
Subcommittee on Health Committee on Energy and Commerce: 
House of Representatives: 

The Honorable Sherrod Brown: 
United States Senate: 

[End of section] 

Appendix I: CMS Medicare Part D Complaint and Grievance Categories: 

Beneficiaries and providers (including pharmacies and physicians) can 
file complaints with the Centers for Medicare and Medicaid Services 
(CMS) regarding Medicare Part D. Within the Complaint Tracking Module 
(CTM), beneficiary complaints are assigned to 14 categories and 
provider complaints to 6 categories, which are further delineated into 
186 subcategories. CMS requires that plan sponsors report grievances 
based on 11 CMS-defined categories, which are somewhat similar to the 
CTM categories, but do not include subcategories. A description of the 
complaints and grievances categories is listed below. 

Table 1: CTM Complaints Categories: 

Complaints filed by beneficiaries: 

Category: Benefits/Access; 
Includes complaints about: Benefits and access to prescription drugs; 
Number of subcategories: 13. 

Category: Confidentiality/Privacy; 
Includes complaints about: Release of information; 
Number of subcategories: 2. 

Category: Contractor/Partner Performance; 
Includes complaints about: CMS contractors/partners providing support 
to Part D; 
Number of subcategories: 6. 

Category: Customer Service; 
Includes complaints about: Quality of customer service; 
Number of subcategories: 12. 

Category: Enrollment/Disenrollment; 
Includes complaints about: Joining and leaving a plan; 
Number of subcategories: 22. 

Category: Exceptions/Appeals; 
Includes complaints about: Plans' exceptions and appeals processes; 
Number of subcategories: 3. 

Category: Formulary; 
Includes complaints about: Plans' coverage of needed drugs; 
Number of subcategories: 7. 

Complaints filed by beneficiaries: Category: Grievances; Includes 
complaints about: Plans' grievances processes; Number of subcategories: 
3. 

Category: Marketing; 
Includes complaints about: Plans' marketing materials and practices; 
Number of subcategories: 7. 

Category: Medication Therapy Management; 
Includes complaints about: Plans' programs to ensure prescription drugs 
are used appropriately; 
Number of subcategories: 13. 

Category: Plan Administration; 
Includes complaints about: Administration of Part D program; 
Number of subcategories: 8. 

Category: Pricing/Co-Insurance/Premiums[A]; 
Includes complaints about: Drug pricing, out of pocket costs, and 
premium withholds; 
Number of subcategories: 8. 

Category: Program Integrity Issues/Potential Fraud, Waste, and Abuse; 
Includes complaints about: Potential cases of fraud, waste, and abuse; 
Number of subcategories: 26. 

Category: Quality of Care/Clinical Issues; 
Includes complaints about: Quality of care and clinical issues; 
Number of subcategories: 2. 

Complaints filed by providers: 

Category: Benefits/Access; 
Includes complaints about: Benefits and access to prescription drugs; 
Number of subcategories: 3. 

Category: Implementation; 
Includes complaints about: Implementation of Part D program; 
Number of subcategories: 11. 

Category: Marketing; 
Includes complaints about: Plans' marketing materials and practices; 
Number of subcategories: 8. 

Category: Pharmacies; 
Includes complaints about: Pharmacy payment issues; 
Number of subcategories: 7. 

Category: Program Integrity Issues/Potential Fraud, Waste, and Abuse; 
Includes complaints about: Potential cases of fraud, waste, and abuse; 
Number of subcategories: 23. 

Category: Quality of Care/Clinical Issues; 
Includes complaints about: Quality of care and clinical issues; 
Number of subcategories: 2. 

Source: GAO analysis of CTM categories and subcategories. 

[A] In March 2008 CMS provided this listing of CTM categories. The 
listing included the word "premiums," which was not present in the CTM 
categories at the time we ran our data analyses. 

[End of table] 

Table 2: CMS Grievances Categories: 

Category: Appeals; 
Includes grievances about: Plans' appeals process. 

Category: Benefit Package; 
Includes grievances about: Beneficiary cost sharing and coverage 
issues. 

Category: Confidentiality/Privacy; 
Includes grievances about: Release of information by pharmacy or plans. 

Category: Customer Service; 
Includes grievances about: Customer service of pharmacy, plan, or 
subcontractors. 

Category: Enrollment/Disenrollment; 
Includes grievances about: Joining and leaving a plan. 

Category: Exceptions; 
Includes grievances about: Plans' exceptions process. 

Category: Fraud and Abuse; 
Includes grievances about: Potential cases of fraud and abuse. 

Category: Marketing; 
Includes grievances about: Marketing materials and practices. 

Category: Quality of Care; 
Includes grievances about: Quality of care issues. 

Category: Pharmacy Access/Network; 
Includes grievances about: Pharmacies' filling of prescriptions. 

Category: Other; 
Includes grievances about: Any grievance not included in other 
categories. 

Source: GAO analysis of Medicare Part D reporting requirements for 
contract year 2007. 

[End of table] 

[End of section] 

Appendix II: Comments from the Centers for Medicare & Medicaid 
Services: 

Department Oe Health & Human Services: 
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

June 12, 2008: 

Ms. Kathleen King: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Dear Ms. King: 

Enclosed are the Department's comments on the U.S. Government 
Accountability Office's (GAO) draft report entitled: "Medicare Part D: 
Complaint Rates are Declining but Operational and Oversight Challenges 
Remain" (GAO 08-719). 

The Department appreciates the opportunity to comment on this draft 
report before its publication. 

Sincerely, 

Signed by: 
Jennifer R. Luong, for: 

Vincent J. Ventimiglia, Jr. 
Assistant Secretary for Legislation: 

Attachment: 

Department Of Health & Human Services: 
Centers for Medicare & Medicaid Services: 
Administrator: 
Washington, DC 20201: 

Date: June 11, 2008: 

To: Kathleen M. King:
Director, Health Care: 
Government Accountability Office: 

From: [Signed by] Kerry Weems: 
Acting Administrator: 

Subject: Government Accountability (GAO) Draft Report: "Medicare Part 
D: Complaint Rates are Declining but Operational and Oversight 
Challenges Remain" (GAO-08-719): 

Thank you for the opportunity to review and comment on the above GAO 
draft report. The GAO's study focused on CMS' processes for collection 
and resolution of Medicare Part D complaints and grievances, trends in 
complaints and grievances data since the program's inception, as well 
as opportunities for improvement in CMS' oversight and enforcement 
actions. 

We appreciate the GAO's thorough review of the issues involved, as well 
as the recommendation for fine-tuning CMS' procedures for improving 
oversight of the Medicare Part D grievance process and ensuring that 
beneficiary grievances are being resolved. In particular, the report 
does an impressive job of providing a solid background description of 
the complex processes employed to monitor complaints and grievances 
regarding Medicare Part D contracts. CMS appreciates suggestions on how 
to improve the collection and reporting of Part D complaint and 
grievance data, and has already implemented actions and enhancements 
recommended in the GAO report. 

As you have observed in the course of conducting this study, the 
challenges associated with capturing complaints and grievances from the 
entire Medicare Part D-eligible population are vast and multi-faceted. 
Consistent with the draft report's recommendation, we have been working 
to improve the consistency, reliability, and usefulness of grievance 
data reported by Medicare Part D plan sponsors. and we continue to make 
refinements to our existing procedures related to Part D sponsor 
reporting requirements. As discussed further in our comments below, we 
have issued CY 2008 Technical Specifications to further clarify 
existing data definitions, and we will consider further refinements to 
data collection for the 2010 Part D reporting requirements. Thus, CMS 
believes it may be more constructive for the report to begin by 
acknowledging CMS' overall success in the collection and reporting of 
Part D complaint and grievance data processes over time since the 
establishment of the Part D program benefit. 

The report's main conclusion that CMS' oversight efforts thus far have 
focused almost exclusively on resolving complaints, with little 
attention devoted to plan sponsors' grievance processes, is misleading. 
The report's conclusion is largely based on CMS' analyses of plan 
reported grievance data, and does not consider other means by which CMS 
ensures plan sponsors are addressing grievances in a timely and 
appropriate manner. As a component of the Part D application, sponsors 
must attest that they will establish and maintain grievance processes 
that will ensure appropriate timelines and procedures in accordance 
with Federal Regulations at 42 CFR 423.564. Additionally, CMS' audit 
guides include review of sponsors' grievance processes and timeframes 
for resolution. 

Utilizing complaints and grievance information, CMS has taken 
compliance actions against plan sponsors since the Part D program's 
implementation in 2006. For example, CMS has identified significant 
"star rating" outliers in complaint rates as a component of its 
comprehensive performance analyses. CMS has addressed poor plan 
performance by having formal executive-level compliance calls with 
those sponsors, as well as regular monitoring calls between account 
managers and plans. CMS is in the process of reviewing and identifying 
chronically poor plan performance across years, and we will issue 
warning letters as appropriate to those sponsors. Compliance actions 
have also been conducted based on outliers in grievance rates. These 
actions have included issuance of warning letters and requests of 
business plans from those identified sponsors. 

GAO Recommendation: 

To improve oversight of the Medicare Part D grievance process, and 
provide added assurance that beneficiaries' grievances are being 
resolved, the GAO recommends that CMS undertake efforts to improve the 
consistency, reliability, and usefulness of grievance data reported by 
plan sponsors for each of their contracts. Such efforts include 
enhancing CMS' existing guidance for determining whether beneficiaries' 
problems are grievances, requiring plan sponsors to report information 
regarding the status and issue level of grievances, and conducting 
systematic oversight of these data. 

CMS Response: 

CMS concurs with this recommendation, and notes that it has been 
working to provide Part D sponsors with more comprehensive guidance, 
enhance its oversight activities, and undertake corrective actions as 
needed. We have provided guidance to plan sponsors regarding statutory 
definitions of grievances, coverage determinations and appeals in order 
to facilitate accurate reporting of these data to CMS. One example of 
CMS' continued efforts to educate sponsors further on this issue is the 
2008 Reporting Requirements technical Specifications released this 
spring, which reiterate that an enrollee's request for a coverage 
determination or a redetermination regarding drug coverage is not 
considered a grievance. and refer Part D Plan Sponsors to Subpart M, 
section 423.564 of the regulations on the Voluntary Medicare 
Prescription Drug Benefit for more information about Part D grievances. 
In addition, the 2008 Reporting Requirements "Technical Specifications 
instruct sponsors to exclude complaints received by 1-800-Medicare or 
recorded in the complaint Tracking Module from their grievance data. 

The CMS staff has also conducted compliance activities based on 
contracts identified to be outliers from their grievance data, 
including sending warning letters and requesting business plans. CMS 
continues to perform quality assurance, analyses, and oversight of plan 
reported data, including grievance data. These activities include 
identifying plans with high rates for grievance categories and total 
grievances by enrollment, as well as evaluating for correlations 
between grievances and complaints. CMS' continued collection and 
analyses of grievance data will ensure all sponsors' grievance data and 
processes are evaluated comprehensively. 

With regard to requiring plan sponsors to report grievance status and 
issue level, CMS will consider the addition of data elements related to 
sponsors' timeliness and quality of grievance resolution in the new set 
of Reporting Requirements for calendar year (CY) 2010. 

The CMS would also like to address the report's statement, "Although 
immediate need and urgent complaints were resolved, on average, much 
more quickly - 12 days for immediate need complaints and 16 days for 
urgent complaints, these average resolution times still exceeded CMS's 
resolution timeframes." While CMS agrees with the findings fur the May 
2006 - October 2007 time period of the report, analysis for a more 
recent time period (November 2007 - April 2008) demonstrates that case 
resolution timeframes are trending towards CMS' standard timeframes. 
For immediate need complaints (defined as a complaint that is related 
to the beneficiary's need for medication where the beneficiary has 2 or 
less days of medication left) the CMS standard for resolution is within 
2 days. For urgent need complaints {defined as a complaint that is 
related to the beneficiary's need for medication where the beneficiary 
has 3 to 14 days of medication left) the CMS standard for resolution is 
within 10 days. Specifically, during the November 2007 - April 2008 
time period, 32,819 immediate need and 11,105 urgent cases were 
processed. On average, immediate need complaints were resolved in less 
than 3 days and urgent complaints were resolved in 6 days-well within 
CMS' standard resolution timeframe. 

In addition, there are a number of factual inaccuracies set forth in 
the report, as illustrated in our more detailed comments (attached). 
Some or these comments were previously provided by CMS in response to 
the GAO Draft Statement of Facts. 

Again, we thank you for the opportunity to review and comment on this 
report. 

[End of section] 

Footnotes: 

[1] Pub. L. No. 108-173, tit. I, § 101, et seq., 117 Stat. 2066, 2071- 
2152 (codified at 42 U.S.C. §§ 1395w-101--1395w-152). 

[2] Plan sponsors include health insurance companies and pharmacy 
benefit managers (PBMs). Although PBMs typically manage prescription 
drug benefits for third-party payers, some PBMs have contracted 
directly with Medicare to offer Part D plans. 

[3] MMA requires that plan sponsors offer beneficiaries a standard 
benefit plan, which specifies deductible and coinsurance amounts, or a 
plan with benefits that are actuarially equivalent to the standard 
plan. 

[4] Part D sponsors' formularies--lists of plan-covered drugs-- 
generally must cover at least two drugs in each drug category and 
class. CMS also requires formularies to cover "all or substantially 
all" drugs within six designated drug categories: antidepressants, 
antipsychotics, anticonvulsants, anticancer, immunosuppressants, and 
HIV/AIDS. 

[5] In addition, beneficiaries who qualify for both Medicare and 
Medicaid--a jointly funded federal-state health care program that 
covers certain low-income families and other individuals--are known as 
full-benefit dual eligibles. If they do not independently enroll in a 
Part D plan, CMS must automatically enroll them in a prescription drug 
plan. 

[6] See Mike Leavitt, Secretary's One Month Progress Report on the 
Medicare Prescription Drug Benefit (Washington, D.C.: Department of 
Health and Human Services, Feb. 1, 2006). 

[7] Beneficiaries or their authorized representatives (including 
advocates and caregivers) can file complaints or grievances. In 
addition, providers and pharmacists can also file complaints. 

[8] CMS considers all other complaints "routine," and CMS officials 
encourage that routine complaints be resolved within 30 calendar days. 

[9] Additionally, a 14-day extension may be granted at the 
beneficiary's request or if the sponsor justifies the need for 
additional time and indicates how the extension is in the interest of 
the beneficiary. However, certain types of grievances must be responded 
to within 24 hours. See 42 C.F.R. § 423.564(e),(f). 

[10] For further information on the Part D coverage determinations and 
appeals processes, see GAO, Medicare Part D: Plan Sponsors' Processing 
and CMS Monitoring of Drug Coverage Requests Could be Improved, 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-47] (Washington 
D.C.: Jan. 22, 2008). 

[11] We determined that including complaints filed after October 31, 
2007, could skew our analyses because CMS and plan sponsors may not 
have had sufficient time to resolve such complaints as of the time of 
our December 2007 data request. Specifically, including complaints 
filed after this date could have indicated that a disproportionate 
number of complaints remained unresolved. 

[12] We did not report on complaint rates for individual Part D 
contracts because our initial analyses found that patterns in complaint 
rates for individual contracts were generally consistent with trends in 
the aggregate rates. 

[13] These eight contracts accounted for 40 percent of Part D 
enrollment in 2006. 

[14] Some employers also offer Part D plans, although such employer- 
sponsored plans represent a small percentage of all Part D plans. 

[15] These contracts require plan sponsors to operate their plans in 
compliance with federal law and regulations and CMS guidance and 
policies. 

[16] A plan sponsor may have one contract and offer multiple plans or 
have several contracts and offer multiple plans. 

[17] The annual election period runs from November 15 to December 31 of 
each year. Beneficiaries may be able to change plans at other times 
depending on special circumstances. For example, beneficiaries may 
enroll in a new plan if they move to areas not served by their plan. In 
addition, beneficiaries enrolled in Medicare Advantage may change plans 
once from January 1 to March 31, and dual-eligible beneficiaries can 
enroll and switch plans monthly. 

[18] Disputes involving quality of care under Part D may also be 
addressed through the Quality Improvement Organization dispute 
resolution process. See 42 C.F.R. § 423.564(e)(3)(iii). 

[19] Although uncommon, beneficiaries may also file complaints directly 
with CMS's central office. 

[20] Complaints are not assigned a specific "filing date" until they 
are uploaded into the CTM. Complaints entered through 1-800-Medicare 
are uploaded into the CTM the next business day after they are 
received. 

[21] For some enrollment complaints, such as those involving 
dissatisfaction with an enrollment decision, the CTM automatically 
flags them as a "CMS Issue" and CMS must resolve them. 

[22] According to CMS, while plan sponsors must resolve immediate need 
complaints within 2 calendar days, CMS caseworkers have 2 business days 
to resolve such complaints. 

[23] Under federal law, plan sponsors are required to provide 
meaningful procedures for hearing and resolving grievances between 
themselves and their enrollees. 42 U.S.C. § 1395w-104(f). Plan sponsors 
must also maintain records on grievances including the date of receipt, 
the date of final resolution, and the date the enrollee was notified of 
the resolution. 42 C.F.R. § 423.564(g). 

[24] Expedited grievances--those which involve a sponsor's refusal to 
expedite a decision concerning payment for or provision of a drug--must 
be resolved within 24 hours. 

[25] See CMS, Medicare Part D Reporting Requirements, Contract Year 
2007 (Baltimore, Md.: Updated Dec. 15, 2006). 

[26] Certain plan sponsors, which offer a comprehensive optional 
benefit under both Medicare and Medicaid through the Program of All- 
Inclusive Care for the Elderly, are not required to report grievance 
data. 

[27] According to CMS, the agency can initiate a formal compliance 
action at its discretion without first making a call to a sponsor. 

[28] These corrective action plans are then monitored by CMS until the 
plan comes into compliance. 

[29] The average complaint rate is based on an average monthly 
enrollment of about 23.4 million enrollees over the 18-month period 
studied. We found no noticeable difference in aggregate complaint rates 
between PDPs and MA-PDs, which suggests that enrollment in either a PDP 
or MA-PD did not noticeably affect the likelihood that a beneficiary 
would file a complaint. In addition, we were unable to evaluate the 
magnitude of this complaint rate because we had no basis of comparison. 

[30] Most enrollment and disenrollment complaints were assigned to five 
subcategories--delayed enrollment processing, inappropriate enrollment, 
inappropriate disenrollment, untimely processing of disenrollment 
requests, and other enrollment/disenrollment issues. 

[31] CMS did not separately track premium withholding issues until 
February 2007, and CMS officials indicated that prior to that time such 
issues were typically placed into the "other pricing and co-insurance 
issues" subcategory. Therefore, the number of cases related to premium 
withholding issues during the period May 2006 through October 2007 was 
likely higher. 

[32] Ongoing GAO work is examining the process for withholding Medicare 
premiums from beneficiaries' Social Security payments. This study, 
which is designed to provide information about the challenges CMS and 
SSA face in processing premium-withholding transactions, is estimated 
to be complete in summer 2008. 

[33] For the purposes of this analysis, we measured resolution times 
for each complaint by subtracting the date the complaint was entered 
into the CTM--known as the "data entry date"--from the date the 
complaint was resolved. When conducting our analyses, we found that 
about 4 percent of the resolved complaints had either missing or 
invalid resolution dates, and thus, those complaints are excluded from 
our analysis. 

[34] The average resolution time of 25 days reflects the fact that the 
vast majority of complaints were routine. For the 18-month period, 
routine complaints took an average of 29 days to resolve. 

[35] CMS utilizes a computer program, which analyzes CTM categories, 
subcategories, and word patterns to identify complaints that are beyond 
the control of plan sponsors to resolve. We used this computer program 
to determine the proportion of complaints, which required CMS's 
intervention to resolve. 

[36] For example, while there were about 9,000 complaints related to 
enrollment/disenrollment issues filed in December 2006, there were more 
than 19,000 filed in January 2007. 

[37] CMS officials also indicated that beneficiaries are not always 
aware that it can take several months for SSA to process a request for 
premium deductions; therefore, they may file complaints when premiums 
are not immediately deducted from their social security payments. 

[38] Plan sponsors reported zero grievances for over 70 contracts in 
2006, and over 125 contracts for the first 3 quarters of 2007. 

[39] In addition, CMS provides regular training opportunities and 
weekly calls for its staff so they can obtain clarification on 
confusing policies or procedures. 

[40] According to a CMS official, these staff have other 
responsibilities in addition to Part D casework, including conducting 
outreach to plan sponsors and beneficiaries. 

[41] The three CTM categories include complaints about (1) benefits and 
access, (2) enrollment/disenrollment, and (3) pricing and coinsurance. 

[42] Contracts can receive a rating between one and five stars, and 
contracts with higher complaint rates receive lower star ratings. For 
example, contracts that are in the highest 14th percentile in terms of 
complaint rates receive one star. Contracts between the 15th and 34th 
percentile in terms of highest complaint rates receive two stars. The 
star ratings are published at [hyperlink, http://www.medicare.gov]. CMS 
indicated that it does not currently utilize plan sponsor-reported 
grievances data for generating star ratings. 

[43] As required by federal law, in 2005 HHS established the OMO, which 
assists beneficiaries with certain Medicare-related issues and acts as 
a liaison with Part D plan sponsors. 

[44] According to a CMS official responsible for plan sponsor 
compliance, CMS has made formal compliance calls but does not 
systematically track these calls and could not estimate how many it has 
made. 

[45] To determine compliance with the performance requirement, CMS 
measures the number of days that have elapsed between the date the 
complaint was assigned to the contract and when it was resolved. 

[46] CMS officials noted that they will consider developing additional 
performance requirements, such as a requirement related to complaint 
rates, in the future. However, the officials noted that they would want 
to examine data trends from at least a 3-year period before doing so. 

[47] CMS has implemented some policies to ensure that dual-eligible 
beneficiaries maintain access to medications for an interim period 
after beneficiaries are enrolled in a plan. For example, CMS requires 
plan sponsors to provide dual-eligible beneficiaries with a short-term 
supply of drugs if their prescribed drug was not on their plan 
sponsor's list of covered drugs. See Medicare Part D: Challenges in 
Enrolling New Dual-Eligible Beneficiaries, [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-07-272] (Washington, D.C.: May 4, 
2007). 

[48] CMS did not conduct any audits of Part D grievances processes in 
2006. 

[49] Based on its analyses of calendar year 2006 grievances data, CMS 
sent 18 formal compliance warning letters, which requested the 
submission of business plans, to plan sponsors it determined had high 
grievance rates. 

[End of section] 

GAO's Mission: 

The Government Accountability Office, the audit, evaluation and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the performance 
and accountability of the federal government for the American people. 
GAO examines the use of public funds; evaluates federal programs and 
policies; and provides analyses, recommendations, and other assistance 
to help Congress make informed oversight, policy, and funding 
decisions. GAO's commitment to good government is reflected in its core 
values of accountability, integrity, and reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each 
weekday, GAO posts newly released reports, testimony, and 
correspondence on its Web site. To have GAO e-mail you a list of newly 
posted products every afternoon, go to [hyperlink, http://www.gao.gov] 
and select "E-mail Updates." 

Order by Mail or Phone: 

The first copy of each printed report is free. Additional copies are $2 
each. A check or money order should be made out to the Superintendent 
of Documents. GAO also accepts VISA and Mastercard. Orders for 100 or 
more copies mailed to a single address are discounted 25 percent. 
Orders should be sent to: 

U.S. Government Accountability Office: 
441 G Street NW, Room LM: 
Washington, D.C. 20548: 

To order by Phone: 
Voice: (202) 512-6000: 
TDD: (202) 512-2537: 
Fax: (202) 512-6061: 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 

Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]: 
E-mail: fraudnet@gao.gov: 
Automated answering system: (800) 424-5454 or (202) 512-7470: 

Congressional Relations: 

Ralph Dawn, Managing Director, dawnr@gao.gov: 
(202) 512-4400: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7125: 
Washington, D.C. 20548: 

Public Affairs: 

Chuck Young, Managing Director, youngc1@gao.gov: 
(202) 512-4800: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7149: 
Washington, D.C. 20548: