GAO

United States General Accounting Office

Report to Congressional Requesters

November 2000 PRESCRIPTION

DRUGS

Drug Company

Programs Help Some

People Who Lack

Coverage

GAO-01-137

Page 1 GAO-01-137 Drug Company Assistance Programs

Contents

Letter 3

Appendix Appendix I: Scope and Methodology 16

Tables Table 1: Reported Annual Income Limits for Eligibility in Patient

Assistance Programs, 1998 9

Table 2: Programs Offering and Requiring Applications for Refills and

Multiple Products 12

Table 3: Patient Assistance Programs’ Information Requirements 13

Abbreviations

AWP average wholesale price

DEA Drug Enforcement Administration

HHS Department of Health and Human Services

PACE Pharmaceutical Assistance Contract for the Elderly

PhRMA Pharmaceutical Research and Manufacturers of America

WAC wholesale acquisition cost
Page 2 GAO-01-137 Drug Company Assistance Programs
Page 3 GAO-01-137 Drug Company Assistance Programs

United States General Accounting Office

Washington, D.C. 20548 Letr

November 16, 2000

The Honorable Tom Bliley

Chairman, Committee on Commerce

House of Representatives

The Honorable Michael Bilirakis

Chairman, Subcommittee on Health

and Environment

Committee on Commerce

House of Representatives

The Honorable Charles E. Grassley

Chairman, Special Committee on Aging

United States Senate

As the Congress considers Medicare beneficiaries’ access to prescription

drug coverage, there is increased interest in the options available to help

vulnerable populations obtain access to needed medications. Among these

options are patient assistance programs operated voluntarily by

pharmaceutical companies. These programs are part of many companies’

philanthropic efforts to provide prescription medications to those who

need, but cannot afford, their products. You asked us to examine

pharmaceutical company assistance programs that provide their products

to low-income patients, including Medicare beneficiaries. This report

describes (1) the scope of the programs, including the amount of assistance

provided and eligibility requirements, and (2) the design of the programs,

such as the procedures for obtaining assistance.

To develop this information, we surveyed pharmaceutical companies with

patient assistance programs that offer outpatient, self-administered

prescription drugs. We identified 88 programs and received responses from

72. The programs were identified through pharmaceutical industry groups

and other organizations that compile information about patient assistance

programs. We also obtained information on patient assistance programs

from Pharmaceutical Research and Manufacturers of America (PhRMA).1

We also interviewed providers who have used patient assistance programs,

individuals affiliated with organizations that provide information to the

1

PhRMA is a trade association whose membership represents most large pharmaceutical

companies and many smaller biotechnology drug companies.
Page 4 GAO-01-137 Drug Company Assistance Programs

public about patient assistance programs, and representatives from drug

industry, public hospital, and public hospital pharmacy groups. Because of

data limitations, we could not determine the proportion of program

participants who were Medicare beneficiaries. We did not independently

verify the information provided by the survey respondents, providers, or

others we interviewed. We conducted our work in accordance with

generally accepted government auditing standards between January and

October 2000. Appendix I describes our methodology in more detail.

Results in Brief Patient assistance programs, offered voluntarily by drug companies, are

generally designed to provide prescription drugs to low-income persons

who lack drug coverage. Almost all large research-based drug companies,

as well as some smaller companies, offer these programs and generally

consider them to be short-term, last-resort options for people unable to

afford their products. Collectively, patient assistance programs offer a wide

variety of prescription drugs, including medications commonly prescribed

to Medicare beneficiaries. A survey conducted by PhRMA found that its

members’ programs provided $500 million worth of products to 1.5 million

people in 1998. Our survey of programs yielded similar findings. Programs’

eligibility requirements, usually based on income and insurance status,

target people in need of financial assistance.

Assistance programs typically rely on health care providers’ involvement

with some or all stages of applying for and receiving drugs from the

programs. Information about these programs and their application rules is

typically provided to health care providers by drug company

representatives. Once providers and patients learn about the programs,

applying for and receiving assistance generally entails a number of

procedures that vary among the programs. Half of the programs we

contacted require a provider to apply for assistance on behalf of the

patient, while some programs allow a patient or patient advocate to apply.

Most programs have application forms that request varying amounts and

types of information—commonly regarding the patient’s income and drug

and health insurance coverage. Some programs also require applicants to

provide documentation of income or insurance status, while others rely on

the provider to verify that the patient is eligible. Once the application is

approved, most programs send the drug to the provider, but some programs

provide vouchers or send the drug directly to the patient. Patients are

rarely required to pay a copayment, dispensing fee, or shipping charges

before receiving the drug.
Page 5 GAO-01-137 Drug Company Assistance Programs

Background As prescription drugs have become an increasingly significant part of

medical care and drug costs have continued to rise, access to drug

coverage has become an important concern. Total spending on prescription

drugs, as well as the share of all health expenditures accounted for by

drugs in the United States, has grown steadily in recent years. In 1998, total

spending on drugs in the United States was $90.6 billion. Most private

health insurance policies and all Medicaid programs cover outpatient

prescription drugs, although the benefits may be limited. However,

approximately 15 percent of the U.S. population under age 65, or about 42

million people, did not have any health insurance coverage for the entire

year in 1999.2 Those with household incomes below $25,000 were less likely

to have health insurance than those in higher income categories.

2

Robert J. Mills, Health Insurance Coverage: 1999, U.S. Bureau of the Census

www.census.gov/Pressrelease/www/2000/cb00-160.html (cited Sept. 29, 2000).
Page 6 GAO-01-137 Drug Company Assistance Programs

Because of the Medicare program, nearly all Americans aged 65 and over

have health insurance. However, the traditional Medicare program3 does

not cover most prescription drugs that are self-administered outside of a

hospital or doctor’s office. In 1996, the latest year for which analyzed data

are available, 31 percent of Medicare beneficiaries, approximately 11.6

million people, did not have access to drug coverage, could not afford to

purchase coverage, or chose not to purchase coverage. Medicare

beneficiaries’ higher prevalence of chronic medical conditions and

disproportionate use of prescription drugs can translate into a potential

financial burden, especially among those without any prescription drug

coverage. In 1996, average total spending for outpatient prescription drugs

among the over 37 million Medicare beneficiaries was $674 per person,4

compared with an estimated $156 per person for the nonelderly

population.5 In that same year, 7 percent of Medicare beneficiaries had

$2,000 or more in total drug costs.6

In general, Medicare beneficiaries with low incomes are more likely to lack

drug coverage than those with higher incomes. Seventy-three percent of

Medicare beneficiaries with incomes above 200 percent of the poverty

threshold had drug coverage at some point during 1996, compared with 61

percent of Medicare beneficiaries with incomes between 100 and 150

percent of the poverty threshold.7 The exception to this pattern is that a

higher percentage (68 percent) of beneficiaries with incomes below the

poverty thresholds had drug coverage, which is likely due to coverage

through state Medicaid programs for the poorest Medicare beneficiaries.

3

Many Medicare+Choice plans—managed care plans available to some Medicare

beneficiaries—offer coverage for outpatient, self-administered prescription drugs.

4

GAO calculation based on J.A. Poisal and G.S. Chulis, “Medicare Beneficiaries and Drug

Coverage,” Health Affairs (Mar./Apr. 2000), p. 252.

5

Agency for Health Care Research and Quality, Center for Cost and Financing Studies,

National Medical Expenditures Survey Data, Trends in Personal Health Care Expenditures,

Health Insurance, and Payment Sources, Community Based Population, 1996-2005 (updated

Aug. 1998), http://www.meps.ahrq.gov/nmes/papers/trends/96-05(c).pdf , p. 9 (cited Apr. 22,

1999).

6

Department of Health and Human Services (HHS), Assistant Secretary for Planning and

Evaluation, Prescription Drug Coverage, Spending, Utilization, and Prices (Washington,

D.C.: HHS, Apr. 2000), p. 61.

7

GAO calculation based on J.A. Poisal and G.S. Chulis, “Medicare Beneficiaries and Drug

Coverage,” Health Affairs (Mar./Apr. 2000), p. 253.
Page 7 GAO-01-137 Drug Company Assistance Programs

Many Drug Companies

Have Programs to

Provide Targeted

Assistance

Many pharmaceutical companies voluntarily operate patient assistance

programs to provide their drugs to people who would not otherwise have

access to them. Together, these programs offer a wide variety of

prescription drugs, including those drugs commonly prescribed to

Medicare beneficiaries. PhRMA’s 1999 survey of its members found that the

amount of assistance its member companies provided through these

programs has increased since 1996 to a total of $500 million8 worth of

prescription drugs provided to 1.5 million people in 1998. Our survey of

patient assistance programs yielded similar results.9 We could not

determine the proportion of people served by these programs who were

Medicare beneficiaries. Programs generally require applicants to have low

incomes and no drug coverage to be eligible.

PhRMA characterizes patient assistance programs as part of the drug

companies’ mission to provide their drugs to people who might not

otherwise have access. Almost all large research-based companies and

some smaller companies have patient assistance programs to provide their

products free or at a reduced price. Some companies describe their

programs in industry literature as a temporary source of assistance.10

Through these programs, drug companies offer a wide range of drugs to

patients who qualify. Among respondents to our survey, 15 percent offered

all of the company’s outpatient, self-administered prescription drugs

through their programs, while the remaining programs offered some of

their products. Some companies have separate programs for one or more

of their products. Our comparison of medications available through patient

8

According to a PhRMA representative, this is the value of products provided by their

member companies’ patient assistance programs, either in terms of wholesale acquisition

cost (WAC), which is the actual selling price charged by the manufacturer before discounts

to the wholesaler, or average wholesale price (AWP), which is the average list price that a

manufacturer suggests wholesalers charge pharmacies. AWP is sometimes referred to as a

“sticker price” because it is not the actual price that purchasers with market power normally

pay.

9

We could not determine the total number of persons assisted or the value of products for all

companies we surveyed because only 46 of 72 programs provided information on the total

number of persons assisted and only 44 programs provided information on the value of the

products. In our survey, 20 programs used WAC to value the products they provided, 18

programs used AWP value, and 6 programs used another valuation method.

10For examples, see PhRMA, 1999-2000 Directory of Patient Assistance Programs

(Washington, D.C.: PhRMA, 2000), pp. 6, 10, 14, 15, 22.
Page 8 GAO-01-137 Drug Company Assistance Programs

assistance programs with those most commonly prescribed to the enrollees

in the largest state-funded and -administered program providing drug

assistance to the elderly showed that as of June 2000, drug company

patient assistance programs offered all but two of the brand name drugs

among the 50 most commonly prescribed to the state program’s enrollees.

According to the 1999 PhRMA survey, the number of patients assisted by

their members’ patient assistance programs increased 30 percent from 1997

to 1998. Similarly, these companies experienced a 34 percent rise in the

value of the products provided during this period. A PhRMA official said

that the demand for assistance has grown as programs become more

widespread and information about the programs becomes more accessible.

Patient assistance programs typically require applicants to have low

incomes and no drug coverage to be eligible. Fifty-seven of the programs

that responded to our survey said they have established a maximum annual

income level for eligibility to target assistance to the neediest applicants.

Programs with income limits set them at or above the federal poverty

guidelines, which were $8,050 for an individual and $10,850 for a family of

two in 1998 (see table 1).11 Almost two-thirds of these programs reported

that they typically do not disclose income level thresholds to potential

applicants. The two reasons most commonly provided for this lack of

disclosure were concern about false reporting of applicants’ income and

variable income thresholds that can depend on other aspects of an

applicant’s case.

11The federal poverty guidelines are published annually by HHS. They are used by some

public programs to determine eligibility and are loosely referred to as the federal poverty

level.
Page 9 GAO-01-137 Drug Company Assistance Programs

Table 1: Reported Annual Income Limits for Eligibility in Patient Assistance Programs, 1998

Note: Categories were developed by dividing the range between the highest and lowest income limits

into approximate quarters.

Source: GAO analysis of survey data.

According to a representative from PhRMA, companies generally consider

their programs to be a last-resort source of prescription drugs. Consistent

with this policy, many assistance programs consider an applicant’s current

drug coverage status when determining whether applicants may receive

assistance from their program. Patients who have some source of drug

coverage generally are not eligible for assistance. In addition, one-quarter

of all programs responding to our survey reported that they deny assistance

if the applicant is eligible for drug benefits from a public program, even if

the patient currently does not have public drug coverage. Eighty percent of

our survey respondents indicated that patients with insurance who have

exhausted their drug coverage could be eligible for assistance, and most

programs reported that Medicare beneficiaries without supplemental drug

coverage could receive drug assistance through their program.

Individual maximum income limits

Number of programs

reporting (n=72) Family maximum income limits

Number of programs

reporting (n=72)

$8,050-$14,999 12 $10,850-$22,999 19

$15,000-$22,999 11 $23,000-$34,999 9

$23,000-$27,999 6 $35,000-$47,999 6

$28,000-$35,000 6 $48,000-$60,000 1

Income limits vary according to drug

provided

2 Income limits vary according

to drug provided

3

Unspecified income limit 20 Unspecified income limit 19

Total programs with income limits 57 Total programs with income limits 57

Total programs for which income is

not an eligibility criterion

15 Total programs for which income

is not an eligibility criterion

15
Page 10 GAO-01-137 Drug Company Assistance Programs

Health Care Providers

Are Often Needed to

Facilitate Program

Access

Many programs have application and distribution procedures that require

health care provider involvement beyond writing the prescription.

Information about these programs and their application rules is typically

given to health care providers by drug company representatives. Several

sources of information are also available on the Internet. Half of the

programs we surveyed said that the only way to enroll in the program is for

a health care provider to apply on behalf of the patient.12 Other programs

allow patients to apply to the program on their own or through a social

worker or patient advocate. Most programs have an application form and

many require information about an applicant’s income, drug coverage, or

other information about the patient or health care provider13 to determine

eligibility for the program. Almost half of the programs rely on the provider

to confirm the validity of the patient’s information, but others require

accompanying documentation to support the information provided on the

application. Once the application is approved, most programs send the

drugs to the health care provider to distribute to the patient. Patients are

rarely obligated to pay for drugs from the assistance programs.

Program Information

Sources

Among programs responding to our survey, the most frequently cited

method of disseminating program information is having company

representatives discuss the program with health care providers. However,

several providers we interviewed noted that drug companies do not

advertise these programs and that they must ask drug company

representatives for the program information. Some companies offer

additional ways for providers, and in some cases, potentially eligible

patients or others, to obtain information about the programs. For example,

approximately half of the patient assistance programs in our survey

reported listing their program in the PhRMA directory.14

12Our survey did not distinguish between different types of health care providers, for

example, physicians, nurse practitioners, or physician’s assistants, in questions about who is

permitted to perform the tasks required to access program assistance.

13Forty-two of the 47 program applications we received specified that a section of the form

must be completed by a “physician” or required information about the “physician.” Five

programs’ applications indicated that another provider such as a “health care practitioner”

or “licensed practitioner” could provide information on the application.

14 This directory contains information about PhRMA member companies’ patient assistance

programs. According to PhRMA representatives, the directory may not be a complete list of

all assistance programs, because it contains only information about PhRMA member

companies and lists only those programs that ask to be included.
Page 11 GAO-01-137 Drug Company Assistance Programs

Information about these programs is also available on the Internet. Several

Internet sites target their information to providers or instruct the provider

to call for information about the programs. Twelve programs responding to

our survey provide some information about their programs on their

companies’ Web sites. Another site, which became operational in March

2000 and receives some funding from PhRMA, allows providers who

register15 to access information about patient assistance programs and, in

some cases, request assistance on behalf of their patients. Currently, one

company allows drugs to be ordered from its patient assistance program

directly through this site. In addition, we identified two organizations, not

affiliated with individual drug companies, that provide frequently updated

information about pharmacy assistance programs in a standardized format

on their Web sites.16

Program Application

Requirements

Programs we surveyed differed in their application procedures. Half of the

programs we surveyed responded that the health care provider must apply

on behalf of the patient, while others said they allow patients to apply

through a social worker or patient advocate, or on their own. While some

programs said that a letter or telephone call is adequate, most responding

programs reported that an application form is required to apply for

assistance. Most respondents to our survey said that refills are available to

patients who have successfully applied for assistance, although most

programs require patients to reapply (see table 2). Similarly, most programs

that offer more than one product allow patients to receive more than one

drug at a time, with half requiring a separate application for each drug. A

few programs enroll patients for a fixed amount of time, for example, 1

year, and require patients to reapply when that time has elapsed.

15To register with the site, a physician or certain patient advocates must enter an

identification number and password as well as the prescriber’s Drug Enforcement

Administration (DEA) registration number, which is linked to a database that allows the site

to identify the physician.

16The Needy Meds Web site, established and maintained by a physician and a social worker,

is a compilation of drug company assistance programs. The site is funded by the sale of

manuals containing the information collected about the programs. The RxAssist Web site is

intended to help health care providers identify programs offering free pharmaceuticals for

their eligible low-income patients. It is operated by Volunteers in Health Care, a national,

nonprofit program that is funded by the Robert Wood Johnson Foundation.
Page 12 GAO-01-137 Drug Company Assistance Programs

Table 2: Programs Offering and Requiring Applications for Refills and Multiple

Products

a

Sixteen programs that reported offering only one drug were excluded from this analysis.

b

One program did not respond to the question regarding the availability of refills.

c

Three programs did not respond to the question regarding the availability of multiple concurrent

products.

Source: GAO analysis of survey data.

The programs exercise varying degrees of control over the distribution of

their application forms. Thirty-two of the 72 programs said they distribute

application forms to health care providers to use when needed, while 39

programs reported that an application form must be requested from the

program for a specific patient. One program makes the application forms

available over the Internet. Additionally, a nonprofit group makes

application forms available on its Web site for 26 patient assistance

programs that expressly state that they accept photocopied forms.

Providers and individuals who compile program information told us that

some programs are more difficult to access than others. They cited several

factors that can increase the difficulty of applying, such as when the

program accepts only original application forms or requires a large amount

of information on the form. They also noted that separate applications are

needed for patients who need medications from different companies and

that these applications differ. In addition, providers and advocates told us

that program rules that require physicians to complete all or some of the

application can be particularly burdensome to providers who treat a large

number of indigent patients and may create a barrier to program access for

some patients. One provider who uses these programs for his patients said

that routinely using assistance programs can be difficult without staff to

manage the application process because the process can take up to 30

minutes to complete. Providers and advocates we talked with reported that

facilities with staff or volunteers dedicated to helping patients access these

programs were the most successful in securing assistance from them.

Prescription refills

Multiple concurrent

productsa

Program offers option (n=72) 70b 46c

Program requires reapplication

or separate application (n=72)

48 23
Page 13 GAO-01-137 Drug Company Assistance Programs

Many programs said they require information about the patient’s income

and drug and health insurance status to determine eligibility for assistance

(see table 3). Some programs reported that they request other information

from the applicant and most programs said they require a physician’s name

and signature. Almost half of the programs reported that they rely solely on

the health care provider to validate the patient’s information, while 31

programs said that the patient must provide some type of documentation to

support the information on the application. For example, some programs

require documentation of the patient’s income, such as a tax return, or

require documentation that the patient is ineligible for public programs

such as Medicaid.

Table 3: Patient Assistance Programs’ Information Requirements

Source: GAO analysis of survey data.

Drug Distribution and

Payment Requirements

More than three-quarters of the patient assistance programs responding to

our survey indicated they distribute drugs to approved patients through

health care providers. Most of the remaining programs indicated they send

the drug directly to the patient or give the patient a voucher or card that

allows him or her to obtain the drug from a pharmacy. Some providers said

that it can be difficult for them to manage the storage and distribution of

drugs. Several providers said that drug distribution is simpler when a

program gives them coupons or vouchers for drugs, which they then give

Type of information

Programs that require

information (n=72)

Patient information

Income 53

Existing drug coverage 48

Existing health insurance coverage 43

Diagnosis 32

Medical expenses 19

Ineligibility for prescription drug coverage 16

Assets 14

Physician information

Name 67

Signature 64

DEA or license number 59
Page 14 GAO-01-137 Drug Company Assistance Programs

patients to take to pharmacies, rather than when the program ships an

individual product for an individual patient to the provider’s office. One

program reported that once the program’s eligibility decision is made

during a telephone conversation between the provider and the program,

the patient is immediately given a card to take to a pharmacy.

The amount of time it takes for the program to ship the drug, and thus the

minimum time until the drug is available to the patient, varied among

programs. Twenty-eight of the 72 programs said it can take 7 or fewer days

between the program’s receipt of the application and shipping the drug.

One program representative said that it can take up to 42 days from the

date an application is received to the date the medication is shipped to the

health care provider. A clinic director noted the clinic uses the programs

only for medications for chronic illnesses because it can take too long to

receive medications needed for acute conditions. The five programs that

provide patients with a prescription card to take to a pharmacy, rather than

sending drugs to providers, indicated that it takes 5 or fewer days, on

average, to process the application and issue the card. One program that

operates in cooperation with community health centers makes drugs

available immediately through the health centers’ pharmacies, rather than

shipping the drugs after the patient has applied.

While most programs responding to our survey said that patients are not

required to pay for drugs from the programs, 14 of the 72 programs

indicated that patients may be required to pay some amount before the

drug is dispensed. Some of these programs base the patient’s required

payment on the patient’s income. For example, one program requires a

patient contribution based on a sliding scale when the patient’s income is

between 140 and 300 percent of the federal poverty guidelines. Five

programs that distribute the drug through a pharmacy said that the patient

must pay a copayment or dispensing fee to the pharmacy, generally

between $5 and $10. Five additional programs require the patient to pay

shipping and handling charges.

Concluding

Observations

The patient assistance programs operated voluntarily by many drug

companies may provide valuable assistance to a small share of the

uninsured population that complies with program procedures and meets

program requirements. Drug companies characterize their programs as a

last-resort source of prescription drugs, and most programs are not

designed to provide long-term prescription drug coverage. To comply with

programs’ eligibility criteria, which are intended to target patients who are
Page 15 GAO-01-137 Drug Company Assistance Programs

in need of assistance, application procedures require information about the

patient’s financial and insurance status. The provider’s role in the

application process often is significant, involving obtaining applications,

completing all or part of the forms, and receiving and dispensing drugs.

Comments From

External Reviewers

We obtained comments on a draft of this report from representatives from

PhRMA and the Public Hospital Pharmacy Coalition, and the Director of

the Anderson Free Clinic in Anderson, South Carolina. The reviewers

provided technical comments, which we incorporated into the report

where appropriate.

We are sending copies of this report to interested committees and Members

of Congress. We will make copies available to others on request.

If you or your staffs have any questions about this report, please call me at

(202) 512-7119 or John Hansen at (202) 512-7105. Major contributors to this

report are Cristina Boccuti, Kathryn Linehan, Myrna Pérez, and Tricia

Spellman.

Laura A. Dummit

Director, Health Care—Medicare Payment Issues
Page 16 GAO-01-137 Drug Company Assistance Programs

Appendix I

Scope and Methodology ApApenednxidexiIs

To determine the extent of the assistance provided by drug company

programs and programs’ eligibility and other requirements, we sent surveys

to patient assistance programs operated by 82 pharmaceutical companies.

The pharmaceutical companies were identified through member lists from

four pharmaceutical industry groups.1 We identified additional

pharmaceutical companies from two Internet sites that track drug

company patient assistance programs, Needy Meds

(www.needymeds.com ) and the Cost Containment Research Institute

(www.institute-dc.org/prescrip.htm).

2 After contacting each company on

our list, we identified 115 potential programs to survey. We excluded 27

from our final sample because they did not fit the criteria for our analysis.3

Of the 88 remaining programs, we received responses from 72, yielding a

response rate of 82 percent.

We also obtained information about the programs from a PhRMA survey of

its members. The PhRMA survey included only PhRMA member companies

and may have included programs that were nonrespondents to our survey.

Our survey included both PhRMA and non-PhRMA member companies but

excluded information about programs that did not provide outpatient, selfadministered prescription drugs.

To gain an understanding of providers’ experiences using drug company

assistance programs, we interviewed health care providers who have used

these programs, as well as representatives from the Anderson Free Clinic,

the National Association of Public Hospitals and Health Systems, the

Public Hospital Pharmacy Coalition, and organizations that collect

information on and inform potential users about the programs. We asked

them to discuss how these programs are used and, when possible, to

describe their experiences with using patient assistance programs,

including obtaining information, applying to the programs, and distributing

the drugs to the patient.

1

The groups were the Pharmaceutical Research and Manufacturers of America (PhRMA),

the Generic Pharmaceutical Industry Association, the National Association of

Pharmaceutical Manufacturers, and the National Pharmaceutical Association.

2

Using all of our sources, we likely identified most programs, although some programs may

not be represented.

3

Twenty-seven surveys were excluded from our final sample because they were sent to

programs that did not meet our study criterion of dispensing outpatient, self-administered

prescription drugs or they were duplicate surveys for the same program.
Appendix I

Scope and Methodology

Page 17 GAO-01-137 Drug Company Assistance Programs

To compare the drugs available through patient assistance programs with

those used by Medicare beneficiaries, we compared the drugs available

through these programs, as reported by the Needy Meds Web site as of June

18, 2000, with the brand-name drugs commonly prescribed to enrollees in

Pennsylvania’s Pharmaceutical Assistance Contract for the Elderly (PACE)

Program in 1999. PACE is the largest state-funded and -administered

pharmaceutical assistance program for the elderly in the nation.

We did not independently verify the information provided by the survey

respondents, providers, or others we interviewed. We conducted our work

in accordance with generally accepted government auditing standards

between January and October 2000.

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