MEDICARE

Information on Highest- Expenditure Part B Drugs

Statement of James Cosgrove

Director, Health Care

Testimony 

Before the Subcommittee on Health, 

Committee on Energy and Commerce, 

House of Representatives

For Release on Delivery 

Expected at 10:00 a.m. EDT

Friday, June 28, 2013

GAO-13-739T

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-13-739T, a testimony 

before the Subcommittee on Health, 

Committee on Energy and Commerce, 

House of Representatives

June 28, 2013

MEDICARE

Information on Highest-Expenditure Part B Drugs

Why GAO Did This Study

In an October 2012 report, GAO 

examined the levels and trends in 

expenditures, utilization, and average 

annual per beneficiary costs for the 

most expensive Medicare Part B drugs

(GAO-13-46R). Unlike Medicare 

Part D, Part B covers drugs that are 

commonly administered by a physician 

or under a physician’s close 

supervision, such as chemotherapy 

drugs. Many Part B drugs may be 

expensive for the Medicare program 

either because their prices are high or 

because they are used by a large 

number of beneficiaries. In 2010, the 

Medicare program and its beneficiaries 

spent about $19.5 billion on Part B 

drugs, about 9 percent of total Part B 

expenditures.

In this statement, GAO highlights the 

findings from the 2012 report on (1) the 

Part B drugs for which Medicare 

expenditures were highest in 2010 and 

the utilization and expenditure trends 

for these drugs from 2008 to 2010, and 

(2) nationwide spending levels for the 

total U.S. insured population for these 

high-expenditure Part B drugs in 2010 

and Medicare’s percentage of total 

U.S. spending.

GAO calculated the total expenditures 

for each drug using the Centers for 

Medicare & Medicaid Services’ 

national claims files for physicians, 

hospital outpatient, and durable 

medical equipment and ranked the 

drugs, selecting the top 55 for analysis 

of utilization and average annual per 

beneficiary cost. In addition, GAO 

obtained estimates of total U.S. 

expenditures for each of the drugs 

from IMS Health, a company that 

collects and analyzes health care data, 

to estimate Medicare’s share of total 

U.S. spending for these drugs.

What GAO Found

Medicare expenditures for Part B drugs in 2010 were concentrated among 

relatively few drugs. The 55 highest-expenditure Part B drugs represented 

$16.9 billion in spending, or about 85 percent of all Medicare spending on Part B 

drugs, and the 10 highest-expenditure drugs accounted for about 45 percent of 

all Part B drug spending in 2010. Most of these drugs were under patent and 

could be purchased only from a single manufacturer. The number of Medicare 

beneficiaries who used the 55 drugs ranged from over 15 million beneficiaries 

who received the influenza vaccine to 660 beneficiaries who used a drug that 

treats hemophilia. The annual per beneficiary cost of the Part B drugs GAO 

examined also varied widely in 2010, from $13 for influenza vaccine to over 

$200,000 for factor vii recombinant to treat hemophilia. Spending, utilization, and 

prices increased for most of the 55 drugs between 2008 and 2010, with the drugs 

that showed the greatest increases in expenditures also showing the greatest 

increases in utilization.

Five Highest-Expenditure Medicare Part B Drugs, 2010

2010 rank 

by total Medicare 

expenditures Brand name(s) Condition(s) treated

Total 2010

expenditures for 

Medicare beneficiaries 

(millions)

1 Epogen/Procrit 

(end-stage renal 

disease (ESRD) use)

Anemia in ESRD patients

a

$2,000

2 Rituxan Cancer;

rheumatoid arthritis

1,302

3 Lucentis Wet age-related macular 

degeneration (AMD)

1,180

4 Avastin Cancer; wet AMD 1,130

5 Remicade Various autoimmune 

disorders

900

Source: GAO analysis of data from the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the National 

Institutes of Health, and drug manufacturers. 

a

Spending on Medicare beneficiaries accounted for the majority of estimated total 

U.S. spending for 35 of the 55 highest-expenditure drugs in 2010. For 17 of these 

drugs, Medicare spending accounted for more than two-thirds of total U.S. 

spending. Of the $16.9 billion Medicare spent for the 55 highest-expenditure 

Part B drugs, $11 billion, or 65 percent, was spent on drugs for which Medicare 

was the largest U.S. payer.

ESRD is a condition of permanent kidney failure. 

View GAO-13-739T. For more information, 

contact James Cosgrove at (202) 512-7114 or 

cosgrovej@gao.gov.
Page 1 GAO-13-739T

441 G St. N.W.

Washington, DC 20548

Chairman Pitts, Ranking Member Pallone, and Members of the 

Subcommittee:

I am pleased to be here today as you discuss reforms to improve the 

Medicare Part B drug program. Unlike Medicare Part D,1 Part B covers 

drugs that are commonly administered by a physician or under a 

physician’s close supervision, such as chemotherapy drugs.2

My statement will highlight findings from our October 2012 report on highexpenditure Part B drugs.

Many of 

these drugs are particularly expensive for the Medicare program, either 

because they are used by a large number of beneficiaries or because 

their prices are high. Furthermore, both the utilization and cost of these 

drugs are increasing. In 2010, the Medicare program and its beneficiaries 

spent about $19.5 billion on Part B drugs, about 9 percent of total Part B 

expenditures.

3 In that report we examined (1) the Part B 

drugs for which Medicare expenditures were highest in 2010 and the 

utilization and expenditure trends for these drugs from 2008 to 2010, and 

(2) nationwide spending levels for the total U.S. insured population for 

these high-expenditure Part B drugs in 2010 and Medicare’s percentage 

of total U.S. spending.4

 

1

Medicare Part D is a voluntary program through which Medicare covers outpatient drugs.

These findings provide a look at the highestexpenditure Part B drugs in 2010. During or after 2010, several extremely 

expensive products entered the market—Provenge and Jevtana used to 

treat prostate cancer, and Benlysta used to treat lupus, among others.

Given that costly new drugs entered the market and generic versions of 

other drugs became available, a snapshot taken today would likely show 

a somewhat different set of drugs.

2

Medicare Part B covers certain physician, outpatient hospital, laboratory and other 

services, and medical equipment and supplies. Part B drugs are commonly administered 

in physicians’ offices and hospital outpatient departments. In this testimony the term 

“drugs” refers to chemically synthesized drugs and biologicals unless otherwise specified.

Biologicals are products derived from living sources, including humans, animals, and 

microorganisms.

3

GAO, Medicare: High-Expenditure Part B Drugs, GAO-13-46R (Washington, D.C.: 

Oct.12, 2012).

4

For this testimony, we use the term Medicare spending to refer to spending by the 

Medicare program and spending by or on behalf of Medicare beneficiaries.

 
 

Page 2 GAO-13-739T

To identify the highest-expenditure Part B drugs, we used the Centers for 

Medicare & Medicaid Services’ (CMS) national claims files for physicians, 

hospital outpatient, and durable medical equipment. We calculated the 

total expenditures for each drug and ranked the drugs, selecting the top 

55 for further analysis. We also obtained utilization and average annual 

per beneficiary cost from the claims files. We obtained information on the 

purpose and other characteristics of these drugs from the National 

Institutes of Health (NIH), the Food and Drug Administration (FDA), and 

manufacturers. We obtained estimates of total U.S. expenditures for each 

of the drugs from IMS Health, a company that collects and analyzes 

health care data, thereby enabling us to estimate Medicare’s share of 

spending for these drugs.

We conducted the work for our October 2012 report that forms the basis 

for our findings from August 2011 through August 2012 in accordance 

with all sections of GAO’s Quality Assurance Framework that are relevant 

to our objectives. The framework requires that we plan and perform the 

engagement to obtain sufficient and appropriate evidence to meet our 

stated objectives and to discuss any limitations to our work. We believe 

that the information and data obtained, and the analysis conducted, 

provide a reasonable basis for any findings and conclusions.

Medicare bases its payments for most Part B drugs on the average sales 

price (ASP), which is calculated from price and volume data that 

manufacturers report quarterly to CMS, the agency within the Department 

of Health and Human Services (HHS) that administers Medicare. ASP is 

the average price, after rebates and discounts, of all sales of a specified 

drug in the United States; consequently, Medicare’s payment rates for 

Part B drugs are based on prices set in the private market. Payment to 

physicians for most drugs is set by the Medicare Prescription Drug, 

Improvement and Modernization Act of 2003 (MMA) at 106 percent of 

ASP.5

 

5

Pub. L. No. 108-173, § 303(c)(1),117 Stat. 2066, 2239 (adding Social Security Act (SSA) 

§ 1847A(b)). 

Until recently, CMS set payment for separately payable Part B 

drugs administered in hospital outpatient departments at a rate that has 

varied between 104 and 105 percent of ASP, but in 2013, CMS set the 

payment rate at 106 percent of ASP.

Background 
 

Page 3 GAO-13-739T

The MMA directed the HHS Office of Inspector General (OIG) to compare

ASP to the average manufacturer price (AMP), and authorized CMS to 

lower reimbursement for drugs with ASPs that exceed AMPs by 5 percent 

or more.6 OIG’s most recent annual report found that there were 58 drug 

codes in 2011 for which ASP exceeded AMP by at least 5 percent.

Beginning in 2013, as authorized by the MMA, CMS is implementing a 

policy to substitute AMP-based prices in such cases. Specifically, CMS 

will substitute 103 percent of the AMP for the ASP-based reimbursement 

amount when OIG identifies a drug code that exceeds the 5 percent 

threshold in two consecutive quarters or three of four quarters.7

In a 2005 report, we analyzed the use of ASP to set payment rates for 

Part B drugs, and we determined that it was a practical approach 

compared with methods based on alternative data sources.8

Although payment for most Part B drugs is based on ASP, some are paid 

on a different basis. Vaccines, infusion drugs furnished with durable 

medical equipment, and blood products are paid at 95 percent of average 

wholesale price (AWP), which is the manufacturer’s average price to 

wholesalers, but AWP is not defined in law and does not account for 

Nonetheless, 

we had concerns about CMS’s lack of certain information on ASP, and 

characterized it as “a black box.” Specifically, we stated that CMS did not 

have sufficient information on how manufacturers allocate rebates to 

individual drugs sold in combination with other drugs and had no data that 

would allow it to validate the underlying reasonableness of prices. CMS 

did not obtain price and volume data by purchaser type—for example, 

physicians, hospitals, and other health care providers. Furthermore, a 

sufficient empirical foundation did not exist for setting the payment rate for 

Part B drugs at 6 percent above ASP. The addition of 6 percent to the 

price is relatively small for a $10 drug, but it is substantial for a $100,000 

drug.

 

6

AMP represents the average of actual transaction prices paid to manufacturers for a 

given drug and is typically less than any of a drug’s published compendium prices, which 

are list prices suggested by drug manufacturers.

7

42 C.F.R. § 414.904 (2012).

8

GAO, Medicare: Comments on CMS Proposed 2006 Rates for Specified Covered 

Outpatient Drugs and Radiopharmaceuticals Used in Hospitals, GAO-06-17R

(Washington, D.C.: Oct. 31, 2005). 
 

Page 4 GAO-13-739T

prompt pay or other discounts, rebates, and reductions.9 In cases where 

the ASP of a new drug during the first quarter of sales is unavailable, 

payment may be set at 106 percent of the wholesale acquisition cost 

(WAC), which the Social Security Act defines as the manufacturer’s list 

price for the drug to wholesalers or direct purchasers, not including 

prompt pay or other discounts, rebates, or reductions, for the most recent 

month for which information is available.10

For some drugs such as drugs used to treat cancer, certain new drugs, 

and orphan drugs (drugs used to treat rare diseases), Medicare makes 

additional payments, known as transitional pass-through payments, for 2 

to 3 years when these drugs are administered in the hospital outpatient 

setting. For new drugs, pass-through status is intended to make the drugs 

accessible to beneficiaries while a pricing history is developed and the 

price is established.

New drugs generally are patented and, while under patent, can be 

manufactured only by the patent holder. Patents generally last for 

20 years from the date of application. After the patent expires and generic 

forms of the drug are marketed at significantly lower prices, the price of 

the original drug usually falls.

Medicare expenditures for Part B drugs in 2010 were concentrated 

among relatively few drugs. In 2010, the 55 highest-expenditure Part B 

drugs represented $16.9 billion in spending, or about 85 percent of all 

Medicare spending on Part B drugs. Generic alternatives were not 

available for most of the 55 drugs. Most remained under patent and could 

be purchased only from a single manufacturer.

The 10 highest-expenditure drugs, shown in table 1, accounted for about 

45 percent of all Part B drug spending in 2010. Of these 10 drugs, 8 were 

biological products and 4 had orphan drug marketing exclusivity in 

 

9

Prompt pay discounts may be provided when the purchaser pays in advance or within a 

prescribed time period.

10SSA § 1847A(c)(6)(B). The list price is to be determined as reported in wholesale price 

guides or other publications of drug pricing data. 

Total Expenditures, 

Utilization, Average 

Costs per Beneficiary, 

and Trends for Part B 

Drugs from 2008 

through 2010
 

Page 5 GAO-13-739T

2010.11

Table 1: Ten Highest-Expenditure Medicare Part B Drugs, 2010

None of the 10 highest-expenditure drugs had a generic version 

approved by FDA in 2010.

2010 rank by 

total Medicare 

expenditures Brand name(s) Drug description Classification Condition(s) treated

Total 2010 

expenditures for 

Medicare 

beneficiaries 

(dollars in millions)

1 Epogen/Procrit 

(end-stage renal 

disease (ESRD) use)

Epoetin alfa, ESRD Biological a Anemia in ESRD

patients

$2,000

2 Rituxan Rituximab injection b Biological Cancer; rheumatoid 

arthritis 

1,302

3 Lucentis Ranibizumab injection Biological Wet age-related 

macular degeneration 

(AMD) 

1,180

4 Avastin Bevacizumab injection b Biological Cancer; wet AMD 1,130

5 Remicade Infliximab injection b Biological Various autoimmune 

disorders

900

6 Neulasta Injection, pegfilgrastim 

6mg

Biological Prevent infection in 

chemotherapy patients

888

7 Aranesp 

(non-ESRD use)

Darbepoetin alfa, 

non-ESRD 

Biological Anemia in 

chemotherapy patients

504

8 Epogen/Procrit 

(non-ESRD use)

Epoetin alfa, 

non-ESRD 

Biological Anemia in 

chemotherapy and HIV 

patients; prevent blood 

loss in surgical patients

443

9 Alimta Pemetrexed injection b Drug Cancer 394

10 Taxotere Docetaxel injection Drug Cancer 387

Total $9,128

Source: GAO analysis of CMS, FDA, NIH, and drug manufacturer data.

a

ESRD, a condition of permanent kidney failure, is also known as stage 5 chronic kidney disease. 

b

Many of the high-expenditure Part B drugs are used in cancer treatment.

Of the 55 highest-expenditure drugs, cancer and its side effects were 

treated by more drugs (23) than any other set of conditions in 2010. Other 

conditions treated by several drugs included immune system disorders 

These products had orphan drug marketing exclusivity for specific FDA-approved indications in 

2010.

 

11Rtiuxan, Avastin, Remicade, and Almita had orphan drug marketing exclusivity.
 

Page 6 GAO-13-739T

(13), cardiovascular disease and testing (5), chronic kidney disease (5), 

asthma and lung diseases (3), and prevention of organ transplant 

rejection (3).12

The number of Medicare beneficiaries in 2010 who used the 55 drugs we 

reviewed varied widely. Utilization of the 55 highest-expenditure Part B 

drugs ranged from over 15 million beneficiaries who received the 

influenza vaccine to 660 beneficiaries who used factor viii recombinant to 

treat hemophilia A. Although Epogen to treat beneficiaries with end-stage 

renal disease (ESRD) was Medicare’s most expensive Part B drug in 

2010,13 table 2 shows that other drugs among the top 55 were used by 

more beneficiaries, including two vaccines (to prevent influenza and 

pneumonia). Apart from the vaccines, the greatest number of 

beneficiaries (891,000) used Lexiscan, a chemical stress agent used to 

test heart function in patients who cannot take a stress test on a treadmill.

 

12Some drugs were used to treat more than one type of condition.

13Regardless of age, most individuals with ESRD, a condition of permanent kidney failure, 

are eligible for health care coverage under Medicare. Beginning in 2011, CMS 

implemented bundled payments for drugs and services to Medicare dialysis facilities, 

which treat ESRD, in part to discourage excessive use of separately billable drugs such as 

Epogen. Since then, Medicare has not paid separately for 5 of the 55 drugs in our analysis 

when they are used to treat chronic kidney disease: Epogen/Procrit, Aranesp, Zemplar, 

Venofer, and Hectorol.
 

Page 7 GAO-13-739T

Table 2: Ten Most Utilized High-Expenditure Medicare Part B Drugs, 2010

Brand name(s) Condition(s) treated

Utilization

(number of unique 

Medicare beneficiaries)

Influenza vaccine (various) Prevent influenza 15,229,920

Pnuemovax 23, Pnu-Imune Prevent meningitis and pneumonia 1,692,940

Lexiscan Stress agent for myocardial perfusion imaging 890,920

Venofer Anemia in chronic kidney disease patients 329,260

Epogen/Procrit 

(End-stage renal disease (ESRD) use)

Anemia in ESRD patients 323,920 a

Zemplar Hyperthyroidism in chronic kidney disease patients 230,700

Reclast Osteoporosis prevention and treatment; treat Paget’s 

disease of bone

218,060

Avastin Cancer; wet age-related macular degeneration 171,560

Synvisc/Synvisc-One Osteoarthritis of the knee 168,560

Aloxi Prevent nausea and vomiting in chemotherapy and surgical patients 164,000

Source: GAO analysis of CMS, FDA, NIH, and drug manufacturer data.

a

The annual per beneficiary cost of the Part B drugs we examined also 

varied widely in 2010. The influenza vaccines had the lowest average per 

beneficiary cost ($13). Table 3 shows that factor viii recombinant, 

although used by the smallest number of Medicare beneficiaries, had the 

highest average per beneficiary cost—$217,000.

ESRD, a condition of permanent kidney failure, is also known as stage 5 chronic kidney disease.
 

Page 8 GAO-13-739T

Table 3: Ten High-Expenditure Medicare Part B Drugs with Highest Average Annual per Beneficiary Cost, 2010

Brand name(s) Condition(s) treated Classification

Average annual 

cost per beneficiary

Factor viii recombinant 

(various)

Hemophilia A Biological $216,833

Remodulin Pulmonary arterial hypertension Drug 130,772

Ventavis Pulmonary arterial hypertension Drug 84,205

Primacor, Primacor 

in Dextrose

Acute decompensated heart failure Drug 62,790

Erbitux Cancer Biological 25,898

Dacogen Myelodysplastic syndrome Drug 25,858

Herceptin Cancer Biological 25,797

Vidaza Myelodysplastic syndrome Drug 22,957

Sandostatin Lar Depot Acromegaly, diarrhea, and flushing caused by cancerous 

tumors and vasoactive intestinal peptide secreting adenomas

Drug 22,748

Velcade Cancer Drug 19,667

Source: GAO analysis of CMS, FDA, NIH, and drug manufacturer data.

Spending, utilization, and prices increased for most of the 55 most 

expensive Part B drugs between 2008 and 2010. Expenditures for 42 of 

these 55 drugs increased during those years, with the drugs that showed 

the greatest increases in expenditures also showing the greatest 

increases in utilization. The four drugs for which spending and utilization 

increased most were Lexiscan, Treanda, Privigen, and Reclast (see 

table 4). These drugs were approved by FDA in 2007 or early 2008, and it 

took some months for their use to spread.
 

Page 9 GAO-13-739T

Table 4: Ten High-Expenditure Part B Drugs with Largest Changes in Expenditures, Utilization, and Average Price from 2008 

to 2010

Change in expenditures, 

2008-2010a Change in utilization, 2008-2010

Change in average price, 

2008-2010

Brand name(s)

b

Percent 

change Brand name(s)

Percent 

change Brand name(s)

Percent 

change 

Lexiscan 9,550.4 Lexiscan 11,008.7 Ventavis 51.5

Treanda 7,440.2 Treanda 3,271.4 Pneumovax 23, Pnu-Imune 36.0

Privigen 836.3 Privigen 381.1 Myfortic 22.0

Reclast 140.7 Reclast 136.8 Hycamtin 17.5

Myfortic 106.9 Myfortic 73.4 Gammagard Liquid 15.4

Primacor, Primacor in Dextrose 94.0 Hectorol 71.1 Doxil 14.1

Ventavis 93.6 Flebogamma, Flebogamma DIF 46.7 Tysabri 12.3

Vidaza 81.9 Orencia 45.4 Vidaza 11.6

Gammagard Liquid 69.2 Vidaza 41.7 Gamunex 11.3

Orencia 66.9 Gamunex 36.7 Xolair 11.2

Source: GAO analysis of CMS and FDA data.

Notes: Our analysis excludes expenditures and utilization in 2008 that were reported using a not 

otherwise classified code, which may have artificially increased the changes shown for new drugs, 

including Lexiscan and Treanda.

a

We removed factor viii recombinant biological from our analysis of change in expenditures from 

2008-2010 because Medicare claims expenditures for 2008 were lower than values in CMS’s Part B 

National Summary Files and we were not confident that the reported expenditures for 2008 were 

valid.

b

Most price changes from 2008 to 2010 were also increases but the range 

was smaller—from an increase of 52 percent to a decrease of 38 percent.

Four of the 10 drugs that increased most in expenditures were among the 

10 that increased most in price.

The change in price analysis was based on the unweighted average ASP across four quarters in 

each year, and does not include prices for drugs when supplied through infusion equipment.

Spending on Medicare beneficiaries accounted for the majority of 

estimated total U.S. spending for 35 of the 55 highest-expenditure Part B 

drugs in 2010. For 17 of these drugs, Medicare spending accounted for 

more than two-thirds of total U.S. spending. Of the $16.9 billion Medicare 

spent for the 55 highest-expenditure Part B drugs, $11 billion, or 

65 percent, was spent on drugs for which Medicare was the largest U.S. 

payer. Treatment of cancer and its side effects, autoimmune disorders 

and immunodeficiency, and chronic kidney disease were the most 

common uses of the 35 drugs for which Medicare spending was the 

majority of U.S. spending.

Medicare’s Proportion 

of Total U.S. Spending 

on HighestExpenditure Part B 

Drugs 
 

Page 10 GAO-13-739T

Mr. Chairman, this concludes my statement. I would be pleased to 

respond to any questions you or other members of the subcommittee 

have.

For questions about this testimony, please contact James Cosgrove at

(202) 512-7114 or cosgrovej@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last 

page of this testimony. Individuals who made key contributions to the 

testimony include Phyllis Thorburn, Assistant Director; George Bogart; 

Linda Galib; Andrew Johnson; and Elizabeth T. Morrison. 

(291156)
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