Prescription Drugs: Drug Company Programs Help Some People Who Lack
Coverage (Letter Report, 11/16/2000, GAO/GAO-01-137).

As 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. Patient
assistance programs, offered voluntarily by drug companies, are
generally designed to provide prescription drugs to low-income persons
who lack drug coverage, and these programs typically rely on health care
providers' involvement with some or all stages of applying for and
receiving drugs from the programs. 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 in need of assistance, application
procedures require information about the patient's financial and
insurance status. The provider's role in the application process is
significant, involving obtaining applications, completing all or part of
the forms, and receiving and dispensing drugs.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  GAO-01-137
     TITLE:  Prescription Drugs: Drug Company Programs Help Some People
	     Who Lack Coverage
      DATE:  11/16/2000
   SUBJECT:  Drugs
	     Health care programs
	     Pharmaceutical industry
	     Health care cost control
	     Disadvantaged persons
	     Health insurance
	     Health insurance cost control
IDENTIFIER:  Medicare Program

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GAO-01-137

A Report to Congressional Requesters

November 2000 PRESCRIPTION DRUGS

Drug Company Programs Help Some People Who Lack Coverage

GAO-01-137

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

Lett er

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.

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.

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).

Because of the Medicare program, nearly all Americans aged 65 and over have
health insurance. However, the traditional Medicare program 3 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.

Many Drug Companies Many pharmaceutical companies voluntarily operate
patient assistance

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

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

prescription drugs, including those drugs commonly prescribed to Assistance

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 million 8 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.

10 For examples, see PhRMA, 1999- 2000 Directory of Patient Assistance
Programs (Washington, D. C.: PhRMA, 2000), pp. 6, 10, 14, 15, 22.

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.

11 The 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.

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

Number of programs Individual maximum income limits reporting (n= 72) Family
maximum income limits 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

2 Income limits vary according 3 provided to drug provided 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

15 Total programs for which income 15 not an eligibility criterion is not an
eligibility criterion 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.

Health Care Providers Many programs have application and distribution
procedures that require

Are Often Needed to health care provider involvement beyond writing the
prescription.

Information about these programs and their application rules is typically
Facilitate Program

given to health care providers by drug company representatives. Several
Access

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 provider 13 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 Among programs responding to our survey, the most
frequently cited

Sources 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

12 Our 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.

13 Forty- 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.

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 register 15
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 Programs we surveyed differed in their application
procedures. Half of the

Requirements 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.

15 To 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.

16 The 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.

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

Multiple concurrent Prescription refills products a

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

48 23 or separate application (n= 72) 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.

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 Programs that
require Type of information 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 Source: GAO analysis of survey
data.

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

Payment Requirements 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

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 The patient assistance programs operated voluntarily by many drug

Observations 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

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

External Reviewers 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 Pï¿½rez, and Tricia
Spellman.

Laura A. Dummit Director, Health Care- Medicare Payment Issues

Appendi Appendi xes xI

Scope and Methodology 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.

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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Appendix I

Appendix I Scope and Methodology

Page 17 GAO- 01- 137 Drug Company Assistance Programs

United States General Accounting Office Washington, D. C. 20548- 0001

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