[House Hearing, 109 Congress]
[From the U.S. Government Printing Office]
MEDICARE REIMBURSEMENT OF
SUBCOMMITTEE ON HEALTH
COMMITTEE ON WAYS AND MEANS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
JULY 13, 2006
Serial No. 109-83
Printed for the use of the Committee on Ways and Means
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COMMITTEE ON WAYS AND MEANS
BILL THOMAS, California, Chairman
E. CLAY SHAW, JR., Florida CHARLES B. RANGEL, New York
NANCY L. JOHNSON, Connecticut FORTNEY PETE STARK, California
WALLY HERGER, California SANDER M. LEVIN, Michigan
JIM MCCRERY, Louisiana BENJAMIN L. CARDIN, Maryland
DAVE CAMP, Michigan JIM MCDERMOTT, Washington
JIM RAMSTAD, Minnesota JOHN LEWIS, Georgia
JIM NUSSLE, Iowa RICHARD E. NEAL, Massachusetts
SAM JOHNSON, Texas MICHAEL R. MCNULTY, New York
PHIL ENGLISH, Pennsylvania WILLIAM J. JEFFERSON, Louisiana
J.D. HAYWORTH, Arizona JOHN S. TANNER, Tennessee
JERRY WELLER, Illinois XAVIER BECERRA, California
KENNY C. HULSHOF, Missouri LLOYD DOGGETT, Texas
RON LEWIS, Kentucky EARL POMEROY, North Dakota
MARK FOLEY, Florida STEPHANIE TUBBS JONES, Ohio
KEVIN BRADY, Texas MIKE THOMPSON, California
THOMAS M. REYNOLDS, New York JOHN B. LARSON, Connecticut
PAUL RYAN, Wisconsin RAHM EMANUEL, Illinois
ERIC CANTOR, Virginia
JOHN LINDER, Georgia
BOB BEAUPREZ, Colorado
MELISSA A. HART, Pennsylvania
CHRIS CHOCOLA, Indiana
DEVIN NUNES, California
Allison H. Giles, Chief of Staff
Janice Mays, Minority Chief Counsel
SUBCOMMITTEE ON HEALTH
NANCY L. JOHNSON, Connecticut, Chairman
JIM MCCRERY, Louisiana FORTNEY PETE STARK, California
SAM JOHNSON, Texas JOHN LEWIS, Georgia
DAVE CAMP, Michigan LLOYD DOGGETT, Texas
JIM RAMSTAD, Minnesota MIKE THOMPSON, California
PHIL ENGLISH, Pennsylvania RAHM EMANUEL, Illinois
J.D. HAYWORTH, Arizona
KENNY C. HULSHOF, Missouri
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
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C O N T E N T S
Advisory of July 6, 2006 announcing the hearing.................. 2
U.S. Department of Health and Human Services, Herb B. Kuhn,
Director, Centers for Medicare and Medicaid Services........... 7
U.S. Department of Health and Human Services, Robert A. Vito,
Regional Inspector General for Evaluations and Inspections..... 14
Medicare Payment Advisory Commission, Mark Miller, Ph.D.,
Executive Director............................................. 20
U.S. Government Accountability Office, Bruce Steinwald, Director,
Health Care.................................................... 29
Community Oncology Alliance, Frederick M. Schnell................ 53
American Society of Clinical Oncology, Alexandria, Virginia,
Joseph S. Bailes............................................... 63
Immune Deficiency Foundation, Towson, Maryland, Marcia Boyle..... 68
Bioscrip, Elmsford, New York, Richard Friedman................... 72
Primary Immunodeficiency Disease Committee, American Academy of
Allergy, Asthma and Immunology, Philadelphia, Pennsylvania,
Jordan S. Orange............................................... 80
SUBMISSIONS FOR THE RECORD
AmerisourceBergen Specialty Group, Steven Collis, Addison, TX,
Arlette Holland, Chestnut Hill, MA, statement.................... 98
Baker, J., Greenbrier Oncology Clinic, Lewisburg, WV, statement.. 90
Blood and Cancer Center of East Texas, Gary Gross, Tyler, TX,
Cancer Center of Boston, Donna, Strong, Plymouth, MA, letter..... 104
Collis, Steven, AmerisourceBergen Specialty Group, Addison, TX,
Community Oncology Alliance, Fredrick, Schnell, letter and
Connecticut Oncology Association, South Windsor, CT, Dawn
Holcombe, statement............................................ 94
Coplon, Steven, West Clinic, letter.............................. 96
Dawn Holcombe, Connecticut Oncology Clinic, South Windsor, CT,
Greenbrier Oncology Clinic, J. Baker, Lewisburg, WV, statement... 90
Gross, Gary, Blood and Cancer Center of East Texas, Tyler, TX,
Horizon Hematology Oncology, Liza, Owens, Spartanburg, SC,
statement and attachment....................................... 99
Holland, Arlette, Chestnut Hill, MA, statement................... 98
Horizon Hematology-Oncology, Spartanburg, SC, Liza Owens,
statement and attachment....................................... 99
Hunterdon Hematology Oncology, Luanne, Lange, Flemington, NJ,
Lange, Luanne, Hunterdon Hematology Oncology, Flemington, NJ,
Medical Specialists of Fairfield, Glen, Reznikoff, Fairfield, CT,
Needleman, Samuel, Texas Health Resources, Stephenville, TX,
Physicians of Southeastern Gynecologic Oncology, Flemington, NJ,
Physicians of Southeastern Gynecologic Oncology, statement....... 101
Reznikoff, Glen, Medical Specialists of Fairfield, Fairfield, CT,
Strong, Donna, Cancer Center of Boston, Plymouth, MA, letter..... 103
Talecris Biotherapeutics, Research Triangle Park, NC, statement.. 104
Talecris Biotherapeutics, Research Triangle Park, NC, statement.. 104
Texas Health Resources, Samuel, Needleman, Stephenville, TX,
U.S. Oncology, Dan Cohen, letter and attachment.................. 107
U.S. Oncology, Dan Cohen, letter and attachment.................. 107
West Clinic, Steven, Coplon, letter.............................. 96
West Michigan Regional Cancer and Blood Center, A. Soliman
Behairy, Freesoil, MI, letter and attachment................... 110
West Michigan Regional Cancer and Blood Center, Free Soil, MI, A.
Soliman Behairy, letter and attachment......................... 110
Western Washington Medical Group, Julie MacDougall, Everett, WA,
Western Washington Medical Group, Everett, WA, Julie MacDougall,
Schnell, Frederick, Community Oncology Alliance, letter and
MEDICARE REIMBURSEMENT OF
THURSDAY, JULY 13, 2006
U.S. House of Representatives,
Committee on Ways and Means,
Subcommittee on Health,
The Subcommittee met, pursuant to notice, at 1:08 p.m., in
room 1100, Longworth House Office Building, Hon. Nancy L.
Johnson (Chairman of the Subcommittee), presiding.
[The advisory announcing the hearing follows:]
SUBCOMMITTEE ON HEALTH
CONTACT: (202) 225-3943
FOR IMMEDIATE RELEASE
July 06, 2006
Johnson Announces Hearing on Medicare
Reimbursement of Physician-Administered Drugs
Congresswoman Nancy L. Johnson (R-CT), Chairman, Subcommittee on
Health of the Committee on Ways and Means, today announced that the
Subcommittee will hold a hearing on Medicare reimbursement of
physician-administered drugs. In addition, the hearing will examine
physician reimbursement for administration of these drugs. The hearing
will take place on Thursday, July 13, 2006, in the main Committee
hearing room, 1100 Longworth House Office Building, beginning at 1:00
In view of the limited time available to hear witnesses, oral
testimony at this hearing will be from invited witnesses only.
Witnesses will include representatives from the Centers for Medicare &
Medicaid Services (CMS), the Office of Inspector General of the
Department of Health and Human Services, the Medicare Payment Advisory
Commission, the Government Accountability Office (GAO), and
representatives from provider and patient groups. However, any
individual or organization not scheduled for an oral appearance may
submit a written statement for consideration by the Committee and for
inclusion in the printed record of the hearing.
Under the Medicare program certain categories of physician-
administered outpatient drugs, including drugs used in cancer
treatment, and certain drugs used with durable medical equipment are
covered under Part B.
The Balanced Budget Act of 1997 (P.L. 105-33) specified that
Medicare payment for covered outpatient drugs would equal 95 percent of
the average wholesale price (AWP). However, AWPs are not defined by law
or regulation. The AWP for a product is often far greater than the
acquisition cost paid by suppliers and physicians. In addition, the
AWPs do not reflect the discounts, rebates or ``charge backs'' that
manufacturers and wholesalers offer to providers. In 2001, according to
the GAO and the CMS, Medicare overpaid for Part B drugs by more than $1
As a result, Congress significantly reformed the way Medicare pays
for physician-administered drugs in the Medicare Prescription Drug,
Improvement, and Modernization Act (MMA) (P.L. 108-173) from the AWP
methodology to an average sales price (ASP) methodology plus 6 percent.
The ASP represents an average of all manufacturers' final sales prices
in the United States, net of rebates or other discounts and excluding
certain sales at nominal charges. The ASP is calculated quarterly by
CMS from data submitted by manufacturers. The Secretary of the
Department of Health and Human Services has the authority to adjust
reimbursement for a drug when he finds that the ASP does not reflect
widely available market prices.
Physicians can also choose to receive physician-administered drugs
through a Medicare contractor. The competitive acquisition program
(CAP) was established through the MMA. Through CAP, physicians write a
prescription to be filled by a Medicare-contracted supplier that would
then dispense the product to the doctor on a timely basis. The
supplier, not the physician, would be reimbursed by Medicare for the
drug, and the physician is reimbursed for drug administration. The
supplier would be responsible for collection of the 20 percent
coinsurance on the drug payment, lowering the bad debt exposure and
liability of the physician and significantly reducing their paperwork
The MMA also significantly increased the physician fee schedule
payments for oncologists and other specialists by revising and creating
codes. There were also transitional payments for oncologists and other
affected specialists for 2004 and 2005. In 2005 and 2006, CMS
implemented a demonstration program for oncologists in order to assess
and provide support for the quality of care for patients undergoing
chemotherapy. Additional payments per encounter were paid to physicians
who participated in the demonstrations.
In announcing the hearing, Chairman Johnson stated, ``The AWP
process was seriously flawed. The revised payment methodology
fundamentally changes the way Medicare pays for drugs and physicians
services. Congress should continue its oversight and monitor
implementation of the law to ensure that patients have access to high-
quality cancer care and that physicians are reimbursed appropriately.''
FOCUS OF THE HEARING:
Thursday's hearing will focus on implementation of the revised
payment methodology for reimbursement of physician-administered drugs,
and examine the effects of this new payment system on providers and
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Chairman JOHNSON OF CONNECTICUT. The hearing will come to
order. Thank you all for being here.
I am pleased to Chair the second hearing on the Medicare
reimbursement for physician-administered drugs. The Medical
Modernization Act (MMA) (P.L. 108-173) includes very
complicated and significant changes to reimbursement for these
drugs and the services required to deliver them. These changes
were made in order to better align for the reimbursements for
the cost of acquiring and administering drugs.
The purpose of this hearing is to evaluate whether or not
the reimbursement changes have corrected for historic
overpayments in this area, while at the same time maintaining
patient access to these drugs, which include treatments for
oncology, reconstituted human epithelium (rhe), immune
deficiency disorders and some vaccinations. Prior to the MMA,
Medicare only covered drugs that were covered incident to
physician services or administered through covered durable
medical equipment items. These drugs were covered in Medicare
and reimbursed 95 percent of the average wholesale price.
Additionally, Medicare beneficiaries were responsible for 20
percent coinsurance on the drug payment.
As recently detailed in an article of USA Today,
beneficiaries are often held responsible for many thousands of
dollars of cost sharing for oncology therapies throughout the
course of cancer treatment. Seniors without secondary insurance
are simply unable to afford cost sharing of this magnitude.
Uncollected coinsurance is becoming an increasing financial
burden on providers, and many have reported that it is
affecting treatment location decisions for seniors. These
medications treat life-threatening illness; however, it is
unclear how Medicare or certain beneficiaries that are
responsible for coinsurance can be prepared to pay for
therapies costing $100,000 a year.
Finally, Congress chose to place a limit on out-of-pocket
expenditures for any seniors under the Medicare Part D program
to avoid the financial devastation from illness, and yet, part
B, does not have any similar kind of limit. It is now unclear
how to address this issue, and I intend to work with my
colleagues and Centers for Medicare and Medicaid Services (CMS)
and others to evaluate policy remedies.
In addition to changes in Medicare, reimbursement for part
B drugs, the MMA increased reimbursements for chemotherapy
administration. Since 2003, Medicare reimbursement has
fluctuated in this area due to transitional prices which came
to significant--sorry--transitional increases in payments which
were phased out in 2006. Despite the absence of these
transitional payments, the highest volume code, the intravenous
fusion for first hour is 200 percent more than in 2003.
The MMA also mandated the evaluation of drug administration
codes for physicians' services to ensure accurate reporting and
billing for such services, taking into account complexity and
resource consumption, and to appropriately adjust the relative
value units for these codes. I considered this review and
subsequent changes extremely significant to ensuring that
providers were adequately reimbursed for the cost of
administering these drugs and look forward to hearing from
providers and CMS regarding the outcome of this process,
because that seems to me, one of the really big issues that we
need to open up at this hearing outside the claims to
traditional reimbursement to provide for the cost of drugs.
The Medicare Modernization Act also included alternative
methods to purchase and bill for drugs, the Competitive
Acquisition Program, or CAP program. This program is just
beginning its support and clinical impacts on treatment and the
finances of practices that elect to participate.
The Medicare Modernization Act reforms--the payment system
first by setting drug reimbursements at 106 percent of the
average sales price (ASP). We are going to hear a lot of
testimony on the studying of that average price and its
strengths and weaknesses and what it does and does not take
into account, and that is an important aspect of this hearing.
So, I am going to skip over the details which you are, frankly,
all familiar with.
I would rather get on to the controversy, but I am pleased
to welcome the panel. I am pleased to welcome Herb Kuhn,
Director of the Center for Medicare and Medicaid Services, to
testify about the agency's perspective on the adequacy of the
current payment system and early experiences with competitive
acquisition price (CAP). I am also interested to hear about
CMS's efforts to work with providers and oncologists in
particular to evaluate reports in the field.
The Medicare Modernization Act required the Department of
HHS Office of Inspector General (IG) to conduct a study on
physicians' offices of varying sizes and their ability to
acquire drugs at 106 percent of ASP. Robert Vito, Inspector
General for Evaluations and Inspections, will testify on the
finding of his study.
Additionally, Mark Miller, Executive Director of the
Medicare Payment Advisory Commission, MedPAC, will also testify
regarding the Commission's finding on their January 2006 report
titled Effects of Medicare Payment Changes on Oncology Service.
In particular, he will speak to us on the beneficiary access to
oncology treatment and the adequacy of the 106 of ASP as a
Bruce Steinwald, Director of Health Care at the U.S.
Government Accountability Office (GAO), will speak to the
adequacy of reimbursement in the hospital outpatient department
and CMS's ability to collect data on drug acquisition costs.
On the second panel, I would like to welcome Dr. Joseph
Bailes, executive vice president of the American Society of
Clinical Oncology, which represents 24,000 members worldwide
and medical oncologists, from Houston, Texas, will testify on
both reimbursement for drugs and for administrative payments.
Marcia Boyle, president of the Immune Deficiency Foundation
and the mother of a son with primary immune deficiency (PID),
will speak from the patient perspective about the importance
and accessibility of intravenous immunoglobulin (IVIG) to treat
Also, Richard Friedman, chief executive officer of
BioScrip, will testify about the CAP program. BioScrip was
recently awarded a contract to be the vender for the CAP
Finally, Dr. Jordan Orange, of the Primary Immunodeficiency
Disease Committee of the American Academy of Allergy, Asthma
and Immunology, will testify on accessibility and use of IVIG.
IVIG is a plasma-derived product used to treat PID and is
indicated by the Food and Drug Administration for five other
diseases. However, IVIG has been found to be useful treatment
in many, more non-indicated diseases and ailments. There have
been numerous reports of patients, physicians and hospitals
either having difficulty accessing the drug or significant
shifts inside of care. Dr. Orange has provided research on
Dr. Frederick Schnell, an oncologist from Macon, Georgia,
and the upcoming president on the Community Oncology Alliance,
will testify on community practices', especially small
practices' or geographically isolated practices', experiences
with a new reimbursement system.
I want to thank all of the witnesses for participating in
today's hearing. It is of vital importance for Congress and CMS
to be vigilant in our oversight of the implementation of the
Medicare Modernization Act and ensure access to vital and life-
saving treatment is maintained.
Mr. Kuhn, if you will start, please. Excuse me. I yield to
my colleague Mr. Stark.
Mr. STARK. Thanks for holding the hearing. I want to
particularly mention, Madam Chair, that I was pleased to see
our staffs working together on such a bipartisan way in this
hearing. While I am not always sure that I want to take credit
for this, I don't mean to shortchange Bart Miller, but I have a
hunch that I was one of the first people to raise the question
of replacing the average wholesale price (AWP) with
reimbursements that had reflected more accurate acquisition
costs. The average wholesale price scandal, I think, came to
light following investigations from some whistleblower cases,
and we had, I think, such outrageous abuses that would make
Halliburton blush. That raised questions about inappropriate
care, perverse financial incentives on the physicians, and
plain old profiteering at the expense of Medicare and patients
I introduced the average acquisition price bill in 2002,
and it was based on the corporate integrity agreements between
Office of the Inspector General (OIG) and some of the drug
manufacturers. The MMA average sales price provisions were
based in large measure on that legislation and those
agreements. We are going to hear some facts today from our
distinguished first panel about how this average sales price
system is working, and I appreciate all the research that all
of you have done on part B drugs, and I urge CMS to utilize the
resources, the other resources that tabled as they continue
working on this program.
We will hear anecdotes claiming physicians can't afford to
provide part B-covered drugs, and I appreciate that there may
be issues with the formula, but I am quite skeptical that the
claims made by the groups in the second panel in particular are
groups that are funded largely by drug manufacturers. So, we
basically have a second panel made up of people showing for the
drug manufacturers, and I tend to view that with some
I have never quite understood why, although they do it in
Japan, we could do it here, why physicians should be in the
position of trying to make profits as pharmacists. Perhaps they
can explain that to us today. The--on the other hand, I think
that there is no question that physicians should be paid fairly
and adequately, but I always felt that should be left to them,
and in programs like the Report Benefit Savings (RBS), Medicare
Payment Advisory Commission (MedPAC) and others who could tell
the difference between an oncologist and a carbuncle, which I
can't do, and I think we need to have people with the
proficient staff and experience to understand the procedures,
the complications and how they should be paid.
I am dubious as to whether paying people to make a profit
on drugs that they prescribe and administer is in the best
interest of the free market which we are trying to stimulate
here. I think it is clear that ASP reimbursement is more
accurate and, therefore, better than the old wholesale price
system. I want to take seriously the questions of adequate
reimbursements of the doctors and the reduced access, and,
again, I hope that our first panel is prepared to advise us and
recommend to us changes that should be made. So, I want to
thank you for the opportunity, Madam Chair, to examine the
average sales price system and look forward to seeing what we
can do to make it more fair and equitable for all people
concerned. Thank you.
Chairman JOHNSON OF CONNECTICUT. Thank you, Mr. Stark. Mr.
STATEMENT OF HERB B. KUHN, DIRECTOR, CENTERS FOR MEDICARE AND
MEDICAID SERVICES, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Mr. KUHN. Chairman Johnson, Representative Stark, Members
of the Subcommittee, thank you for the opportunity to discuss
with you the way Medicare pays for drugs covered under part B.
As you are aware, the MMA substantially revised Medicare
payment for part B drugs and their administration. part B
Medicare covers a limited number of prescription drugs. In
2005, carriers paid $10 billion for part B drugs, and
intermediaries paid another $5 billion.
Prior to the MMA, Medicare paid for these drugs at 5
percent of the average wholesale prices we heard earlier. This
methodology, however, created incentives for manufacturers to
establish a high wholesale price, while at the same time
selling to physicians at a lower price in order to create a
profit margin or a spread. This resulted in excessive payments
by Medicare and our beneficiaries. The MMA, we believe, as a
large measure successfully addressed this situation, providing
for more appropriate payment for drugs while at the same time
addressing concerns about inadequate payments for drug
Studies by MedPAC, the U.S. Department of Health and Human
Services (HHS), OIG and the GAO suggest that oncologists who
are responsible for the large share of part B drug expenditures
can purchase drugs for the treatment of cancer at less than the
Medicare payment amount. These studies indicate that the ASP-
based system is working appropriately.
In discussions leading up to the passage of the MMA, many
physicians argued that the excess payment of these medications
have subsidized inappropriately low fees for their
administration. Physicians argued that lowering payments for
drugs required increases in the payments for administering the
The MMA significantly revised Medicare payments for
administrative drugs. MMA made several permanent changes to
coding in and--I am sorry, in 2004 and 2005, and CMS
implemented all of these particular provisions. Over all, as a
result of all of these changes, Medicare payments for drug
administration in 2006 are 117 percent higher than they were in
2003. Payment amounts for oncology drug administration codes in
2006 are more than 200 percent higher than in 2003. In
addition, payment is 192 percent higher for the Code accounting
for the most spending. I would note that utilization of part B
drugs has been increasing very rapidly. In our April 2006
letter to MedPAC, we pointed out that the volume and intensity
of part B drugs increased 20 percent per year in 2003, 2004 and
2005. Growth in the volume and intensity of drugs more than
offset the 2005 revisions in pricing that occurred when this
ASP system was implemented in 2005.
Our preliminary review is that there was an almost 20
percent increase in total Medicare payments to oncologists.
This is including both drugs, drug administration, medical
visits and other services between 2003 and 2005, again, the
first year of ASP in 2005. I would also point out that on
Tuesday of this week the administration released the mid-
session review of the budget. Medicare part B expenditures are
now expected to be significantly higher as a result of rapid
growth in the use of physician-related services and hospital
outpatient services, including the volume and intensity of
For a moment now I would like to say a few words about
IVIG, which was raised earlier. CMS and other components of the
Department of Health and Human Services have heard concerns
from some providers and the beneficiaries community about the
adequacy of IVIG supply and Medicare reimbursement. Access to
care is very important to the Medicare Program, and we are
very, very concerned about these reports. During the past year
we have taken several actions to refine Medicare payments rates
for IVIG that could be accomplished within our existing
authority. We established, for example, separate payment
amounts for liquid and powder IVIG in the beginning of April of
2005. For 2006, we created special preadmission handling fees
for both physician offices as well as outpatient departments,
and for the third quarter of 2006, the quarter beginning July
of this month, the Medicare payment amount increased 11.9
percent for the powder form and 3.5 percent for the liquid
There are a number of other factors that are contributing
to the IVIG situation. We have also heard, and I know on the
second panel you will hear from folks about off-label use of
the product and the surge in that area. Manufacturer
consolidations and changes in business practices have also been
occurring in the marketplace. Also, we are seeing and hearing
many reports about diversion of the product into the secondary
or resale market where the product is being reportedly sold at
extremely high markups. To better understand the market for
IVIG and elevated access and reimbursement concerns for patient
and physicians, HHS has commissioned an independent expert
study to assess these factors and others. We want to maintain
access to IVIG, but it is important to determine the causes of
the concerns so we can implement appropriate measures to
achieve this goal. In conclusion, we feel confident that the
changes to the MMA, the way we reimburse for drugs under part
B, has done much to ensure the payment both for drugs and the
administration. The Department plans to continue monitoring
payments, adequacy and access to care for part B drugs. I look
forward to your questions.
Chairman JOHNSON OF CONNECTICUT. Thank you, Mr. Kuhn.
[The prepared statement of Mr. Kuhn follows:]
Statement of Herb B. Kuhn, Director, Centers for Medicare and Medicaid
Services, U.S. Department of Health and Human Services
Chairman Johnson, Representative Stark, distinguished members of
the Subcommittee, thank you for the opportunity to discuss with you the
way Medicare pays for drugs covered under Part B. These drugs are not
covered under the new Part D prescription drug benefit. As you are
aware, the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) substantially revised Medicare payment both for Part
B drugs and their administration. The goals of the MMA changes were to
have Medicare pay appropriately for both Part B drugs and their
administration, and to create a choice for physicians about buying and
billing for Part B drugs or having those drugs furnished to a physician
upon submission of a prescription order. We believe that those goals
have largely been accomplished.
Medicare Part B Drugs
Part B of Medicare covers a limited number of prescription drugs.
These Part B drugs generally fall into three categories: drugs
furnished incident to a physician's service; drugs used as a supply to
durable medical equipment (DME); and certain statutorily covered drugs.
Medicare Part B drug coverage has not been changed by implementation of
the new Medicare Part D drug program. Drugs that were covered by
Medicare Part B before the Part D prescription drug program became
operational continue to be covered under Medicare Part B.
Drugs covered under the ``incident to'' benefit are injectable or
intravenous drugs that are administered as part of or ``incident to'' a
physician's service. The statute limits Part B coverage to drugs that
are not usually self-administered unless the physician participates in
the Competitive Acquisition Program (CAP) for Part B drugs. Under the
``incident to'' provision, the physician must incur a cost for the
drug, and must bill for it. Examples include injectable prostate cancer
drugs (lupron acetate for depot suspension (Lupron & Eligard),
goserelin acetate implant (Zoladex)), injectable drugs used in
connection with treatment of cancer (epoetin alpha (Procrit) and
darbepoetin alfa (Aranesp)), intravenous drugs used to treat cancer
(paclitaxel (Taxol)) and docetaxel (Taxotere)) and to treat non-
Hodgkin's lymphoma (rituximab (Rituxan)), injectable drugs used to
treat rheumatoid arthritis (infliximab (Remicade), injectable anti-
emetic drugs used to treat the nausea resulting from chemotherapy, and
other drugs furnished by physicians, such as intravenous immune
Part B also covers drugs that are administered through a covered
item of DME such as a nebulizer or pump. Inhalation drugs, such as
albuterol sulfate and ipratropium bromide, are frequently administered
through a nebulizer. The Medicare statute requires Part B to cover
certain other specific drugs, including immunosuppressive drugs for
beneficiaries with a Medicare covered organ transplant; hemophilia
blood clotting factor; certain oral anti-cancer drugs; oral anti-emetic
drugs; pneumococcal, influenza and hepatitis vaccines; antigens;
erythropoietin for trained home dialysis patients; certain other drugs
separately billed by end stage renal disease (ESRD) facilities (for
example, iron dextran, vitamin D injections); osteoporosis drugs; and
home infusion of intravenous immune globulin for Primary Immune
In 2005, the preliminary estimate of allowed charges for the
approximately 550 drugs paid for by Medicare Part B carriers is $10
billion. The majority of these expenditures were for drugs administered
incident to a physician's service and drugs furnished in conjunction
with DME. Much of the current spending for carrier paid drugs is
concentrated in relatively few of the approximately 550 covered drugs.
For example, of the $10 billion for carrier paid drugs, 11 drugs
account for 50 percent of spending, 27 drugs account for 75 percent of
spending, and 65 drugs account for 90 percent of spending. The top two
drugs, darbepoetin alfa (Aranesp) and epoetin alpha (Procrit), account
for 17 percent of carrier spending. Three prostate cancer drugs, lupron
acetate for depot suspension (Lupron and Eligard) and goserelin acetate
implant (Zoladex), account for four percent of carrier spending.
Infliximab injection (Remicade), for rheumatoid arthritis treatment,
accounts for five percent of spending. Rituximab (Rituxan), for cancer
treatment accounts for eight percent of carrier spending. Inhalation
drugs account for eight percent of carrier paid drugs (not taking into
account the inhalation drug dispensing fee). Spending of $161 million
for intravenous immune globulin accounts for 1.6 percent of carrier
paid drugs; the total for IVIG increases to approximately $378 million
when preliminary data for hospital outpatient departments are included.
In 2005, roughly 50 percent of spending for carrier paid drug went to
oncologists. Another five percent went to urologists and four percent
went to rheumatologists.
Intermediaries rather than carriers, process claims from both ESRD
facilities and hospital outpatient departments including for Part B
covered drugs. The figures discussed in the previous paragraph do not
include spending for drugs paid for by intermediaries to hospital
outpatient departments, or to ESRD facilities for drugs paid outside
the ESRD composite rate. The preliminary estimate of 2005 allowed
charges for separately billed Part B covered drugs paid to ESRD
facilities is $2.9 billion and $2.0 billion for hospital outpatient
Payment for Medicare Part B Drugs
Prior to the MMA, Medicare paid 95 percent of the Average Wholesale
Price (AWP) for Part B drugs as reflected in published compendia.
Numerous reports by the Office of the Inspector General and the General
Accountability Office indicated that Medicare's payment was
significantly higher than physician acquisition costs for the drugs.
The difference between Medicare's payment and acquisition costs has
come to be referred to as ``spread.'' Physicians have long indicated
that they used the spread to cross-subsidize payments for administering
The MMA revised the system, changing Medicare's payment both for
Part B drugs and their administration. The MMA created two choices for
physicians for payment of Part B drugs. First, a physician may choose
not to buy and bill Part B drugs, but rather obtain such drugs from a
competitively selected vendor upon submission of a prescription order
for specific drugs for a particular beneficiary. This Competitive
Acquisition Program became operational on July 1, 2006. Second, a
physician may choose to purchase drugs in the market and bill Medicare
for them, in which case the MMA specifies that Medicare's payment for
most Part B drugs be 6 percent above the Average Sales Price (ASP). The
ASP-based payment rates became effective January 1, 2005.
The ASP is the average sales price from a manufacturer to all
entities who purchase the drug from the manufacturer (such as
wholesalers and distributors), except for certain low price sales. The
ASP is net of discounts, rebates and other price concessions. The ASP
is calculated from data submitted by manufacturers on a quarterly
basis. CMS takes the manufacturer's reported average sales price for
each specific National Drug Code (NDC) in a billing code (billing
codes, known as HCPCS codes, frequently include more than one NDC) and
weights it by the volume of sales to determine the ASP for the billing
code for a drug. The statute requires that the Medicare payment amounts
are updated each quarter based on data from the second previous
quarter. For example, Medicare ASP payments for the quarter beginning
July 1st are based on manufacturers' average sales prices during the
January to March quarter submitted by April 30th. After receiving data
by April 30th, CMS has just a few weeks to compile the data, calculate
the rates, check potentially erroneous data submissions with
manufacturers, make corrections, publicize the rates, and load the new
pricing files into each of the claims processing contractors' systems.
The ASP system represents the only Medicare payment system where rates
are updated as frequently as quarterly and this allows the Medicare
payment rate to more accurately reflect the most current market
conditions. We continue to work closely with manufacturers to expedite
data submission and ensure adherence with ASP guidance.
Comparing the July 2006 and January 2005 quarters for the top 50
drugs, Medicare payment amounts (ASP plus six percent) are higher for
36 drugs, lower for 13 and the same for one. Payments for five drugs
increased by ten percent or more, while payments for six drugs
decreased by ten percent or more. The biggest decrease, 93 percent, was
for carboplatin, a drug with many generic entrants since 2004. Two
competitor drugs, Aranesp and Procrit, experienced decreases in
payments of 14.6 percent and 11.3 percent respectively. There were
double digit increases and decreases for a number of inhalation drugs
(duoneb: -17.5 percent; budesonide: 12.7 percent; levalbuterol: 17.7
percent; albuterol: 26.2 percent; ipratropium bromide: -27.5 percent).
Other double digit payment increases occurred for bortezomib injection
(Velcade) (12.4 percent) used to treat multiple myeloma, and
epoprostenol injection (Flolan) (12.8 percent) used to treat pulmonary
hypertension. Milrinone lactate injection, another drug with new
generic offerings which is used to treat congestive heart failure, was
the only other drug that experiences a double digit payment decrease
Overall, Medicare payments for drugs did not change substantially
between January 2005 and July 2006. The weighted average payment change
was negative-four percent. Payment decreases, both among drugs for
which there were new generic entrants and among other drugs that had
direct competitors, accounted for much of this decrease. If recent
generic drugs carboplatin, paclitaxel, and milrinone are eliminated
from the total, the weighted average payment change was-1.3 percent. In
addition, if competitor drugs Procrit and Aranesp are also eliminated
from the total overall Medicare payments actually increased by two
percent between January 2005 and July 2006.
The MMA established an alternative method for physicians to obtain
many drugs covered under Part B, called the Competitive Acquisition
Program for Part B drugs. Beginning in July of this year, physicians
have the option of making an annual election as to whether they wish to
purchase these drugs on their own, and be paid based on the ASP rate,
or obtain them from a vendor who will then be responsible for supplying
the drug to the physician, billing Medicare for the drug, collecting
the coinsurance from the beneficiary, and coordinating secondary payer
issues. Participation in CAP is voluntary and physicians who elect into
CAP must abide by their choice for the year, except for certain rare
exceptions. The benefit of participating for physicians is that they do
not incur the expense of purchasing and billing for these medications.
Nor do they have to concern themselves with the Medicare payment rate
for these products and trying to acquire them at the best possible
prices in the market.
Vendors who bid to participate in CAP must meet certain criteria
outlined in the statute and CMS regulations. These include among other
things, issues of: management and operations; experience and
capabilities; licensure; record of integrity; adequacy of internal
controls; and financial performance and solvency.
Potential vendors are required to bid on a particular category of
drugs within a given geographic region. For the first round of CAP, CMS
determined through regulation that there would be only one competitive
acquisition geographic area, which includes all 50 states and
territories, and one category of drugs comprised of approximately 180
of the most common physician administered drugs. Potential vendors'
bids could not exceed the volume weighted average ASP plus six percent
of the full list of drugs. The actual payment rates under CAP are based
on the median of the successful bids. For the first round of CAP, CMS
contracted with BioScrip, Inc. as the CAP vendor.
The first physician election for CAP began in May and concluded at
the end of June. Elections are effective either July 1, or August 1,
depending on when the completed election form was received by the
physician's local carrier, and extends through the remainder of this
calendar year. For 2007 and subsequent years, the physician election
will occur for 45 days in the fall for elections effective for the
subsequent calendar year.
Once a physician has elected to participate in CAP, they must
obtain all drugs on the CAP drug list from their chosen drug vendor
with exceptions in emergency situations and for prescriptions where the
physician explicitly requests that it be furnished as written.
Physicians continue to purchase and bill Medicare under the ASP system
for those drugs that are not furnished by the physician's CAP vendor.
CMS has established a number of information sources for physicians
and other prescribing professionals who have the opportunity to
participate in the CAP. CMS also conducted outreach to the physician
community working with national and local organizations and specialty
societies. On May 11 and again on June 12, CMS hosted national ``Ask
the Contractor'' conference calls during which providers had the
opportunity to learn more about the CAP and ask questions about
participation. Local carriers were also required to provide information
to physicians in their regions.
This initial phase of CAP is providing CMS with the opportunity to
gain valuable experience as a launching pad for future enrollment. We
look forward to expanding the CAP to more categories of drugs in the
future and widening the pool of vendors and interested physicians.
Payments for Administration of Drugs
The MMA required four permanent changes in the data and methodology
used to determine Medicare payments to physicians for administering
drugs. These changes, all implemented on January 1, 2004, permanently
affect Medicare's payment for drug administration services. In addition
to these permanent changes, MMA also provided for transition payments
increasing the underlying drug administration payment by 32 percent in
2004 and 3 percent in 2005.
One significant change was to require use of data from a
survey conducted by the American Society of Clinical Oncologists (ASCO)
on the costs of running a practice. These data are now used in the
methodology to calculate Medicare payments for drug administration
services. MMA excluded these increased expenditures from the budget
neutrality requirement so that these changes did not reduce payments
for other services under the physician fee schedule.
Another MMA change required the Secretary to set work
relative value units for drug administration services at the same level
as the lowest level office visit billed by a physician.
Still another MMA change required use of data on
compensation of oncology nurses from the ASCO survey in the methodology
to calculate practice expense relative value units for drug
Finally, MMA required the Secretary to review and make
appropriate changes in payment for multiple chemotherapy drugs
furnished on a single day through the push technique.
In addition to the above changes, in order to ensure that drug
administration codes accurately reflect services furnished, the MMA
required prompt evaluation of existing codes used by physicians to bill
for administering drugs to patients. The MMA also required the
Secretary to use existing processes and authority to expedite
consideration of coding changes and new relative value units. Changes
in expenditures resulting from this review of codes were exempt from
the budget-neutrality requirement that would otherwise apply. Because
Medicare uses the American Medical Association's Current Procedural
Terminology (CPT) system for coding of physicians' services, the CPT
Editorial Panel undertook an expeditious review of drug administration
codes. The CPT Editorial Panel adopted some new drug administration
codes and refined several existing codes. The AMA's Relative Value
Update Committee (RUC) made recommendations to CMS on the relative
values for new drug administration codes.
The new codes made changes to address concerns that physicians had
raised about the drug administration codes. In particular, a new code
was established to reflect the higher resource costs associated with
infusing a second cancer drug on the same day. In addition, oncologists
and other physicians can now bill Medicare for more than one
administration of a non-chemotherapy drug as they can do currently for
These new and refined CPT codes became operational in 2006.
However, in order to make them operational in 2005, in advance of their
formal inclusion in the CPT system, we established temporary codes that
were used during 2005. We used the RUC recommended values for the new
and refined drug administration codes. The MMA specified that the
changes in expenditures resulting from this review of codes were exempt
from the budget-neutrality requirement that would otherwise apply.
Overall, as a result of all these changes, Medicare payments for
drug administration in 2006 are 117 percent higher than they were in
2003. Payment amounts for four oncology drug administration codes in
2006 are more than 200 percent higher than in 2003. In addition,
payment is 192 percent higher for the code accounting for the most
spending--chemotherapy administration, intravenous infusion technique;
up to one hour, single or initial substance/drug.
Other Changes Affecting Payments to Oncologists
Concurrent with implementation of the ASP system and increased
payments for drug administration codes, we also made other changes and
clarifications affecting oncologists and other physicians. Prior to
2005, injections furnished on the same day as other physician fee
schedule services were bundled in to payment for the medical visit and
not paid separately. Beginning with 2005, Medicare made separate
payment for injections furnished on the same day as other physician fee
Considerable physician effort may be required to monitor and attend
to patients who develop significant adverse reactions to chemotherapy
drugs, or otherwise have complications in the course of chemotherapy
treatment. Some physicians are not aware of their ability to bill for
these services. We clarified that these services can be billed
appropriately using existing CPT codes, including, depending on the
services involved: billing for a physician visit; billing for a higher
level physician visit; billing using a prolonged service code; and
billing using a critical care service. Billing for services relating to
a significant adverse reaction to chemotherapy drugs would be in
addition to billing normally allowed for the physician's care of a
cancer patient. We issued coding guidance to assure appropriate billing
for these services, potentially providing additional revenues for
practices that had not used these billing codes appropriately in the
In order to assess the quality of care for cancer patients
undergoing chemotherapy, Medicare initiated a one-year nationwide
demonstration project during 2005. The demonstration collected data on
three patient assessment elements for each day that chemotherapy was
administered. We established 12 new billing codes, four in each of
three patient status categories: (i) nausea and/or vomiting; (ii) pain;
and (iii) fatigue. Physicians reported one of the four different levels
in each of these three categories. The demonstration project was open
to all oncologists. Payment of $130 was made to physicians who
submitted the three codes in conjunction with each day of chemotherapy
administration. We are using a contractor to evaluate this
demonstration and the evaluation is ongoing.
For 2006, we are conducting a one-year demonstration where
physicians treating cancer patients are routinely consulting clinical
practice guidelines, and comparing management of their patients to that
recommended in the guidelines. As part of this demonstration they are
also reporting on the patient's disease status, and the focus of their
visit with the patient--all data not routinely captured in the claims
processing system. Participating oncologists and hematologists qualify
for additional payments if they submit data from each of the three
categories when they bill for an evaluation and management (E&M) visit
of level 2, 3, 4, or 5 for established patients. Practices reporting
data on all three categories qualify for an additional payment of $23
in addition to the E&M visit.
The evaluation of the 2006 demonstration will use a combination of
quantitative and qualitative methods to examine the impact of the
demonstration on: Medicare spending; beneficiary outcomes; physician
practice adherence to clinical guidelines; and financial status of
physicians' practice. In addition, through field assessments and
physician surveys, the evaluation will examine how the demonstration
impacted the way physicians delivered care to beneficiaries, and the
types of modifications they needed to make in order to be able to
report the data. The evaluation will include a validation study of
physician-reported adherence to guidelines developed by the American
Society of Clinical Oncology and the National Comprehensive Cancer
Network. The evaluation of the 2006 demonstration is being managed
jointly by CMS' Office of Research, Development and Information (ORDI)
and the National Cancer Institute (NCI). Contractor bids have been
submitted for the evaluation and an award is expected to be made by
CMS and other components of the Department of Health and Human
Services (HHS) have heard concerns from some providers and beneficiary
groups about the adequacy of the intravenous immune globulin (IVIG)
supply and Medicare reimbursement for these products. Access to care is
very important to the Medicare program and we are concerned about these
During the past year, we have taken several actions to refine
Medicare payment rates for IVIG that could be accomplished within our
existing authorities. We established separate payment amounts for
liquid and powder IVIG beginning April 2005. For 2006, we created
special pre-administration handling fees of about $72 for physicians
and $75 for hospital outpatient departments that administer IVIG. At
the same time we have continued to work with manufacturers to ensure
that they accurately calculate the ASPs that they report to us since
these data are used to determine Medicare's payment amounts. The
Medicare payment rate for IVIG is updated quarterly based on the most
recent data reported by manufacturers. For the third quarter of 2006,
the Medicare payment amount increased 11.9 percent for lyophilized IVIG
(powdered form) and 3.5 percent for liquid IVIG.
The current IVIG market involves a complex set of demand, supply
and other factors. Demand for IVIG has grown significantly in recent
years, as off-label use of the product has increased. Because IVIG is a
product derived from human plasma, supply increases require significant
start-up time. Supply availability for IVIG has historically been
cyclical. IVIG production capacity contracted somewhat in 2004 but
increased again in 2005, and manufacturers indicated that they expect
supply to increase further in 2006. The industry barometer of supply
adequacy for May 2006 indicates that ``inventory levels are between 2-5
weeks and supply is still adequate.''
In addition, there are a number of other factors contributing to
the complex IVIG situation. Manufacturer consolidations and changes in
business practices have occurred, such as placing IVIG on allocation.
Allocation means that a substantial portion of the IVIG distributed in
the United States is not for sale on the open market, but has been
obligated for delivery to Group Purchasing Organizations (GPOs),
distributors, and end-users based on long-term contracts with
manufacturers. There are also reports of some IVIG product being
diverted to the secondary (resale) market where product is reportedly
being sold with extremely high markup.
A number of components of HHS continue to work together, and with
manufacturers, providers, patient groups, and stakeholders to
understand the present situation and to assess potential actions that
will help to ensure an adequate supply of IVIG and patients receiving
appropriate and high quality care. To better understand the market for
IVIG and evaluate access and reimbursement concerns from patients and
physicians, HHS has commissioned an independent, expert study to assess
these factors. We want to maintain access to IVIG, but it is important
to determine the causes of the current concerns so we can implement
appropriate measures to achieve this goal. We plan to continue to work
with all stakeholders to understand the forces causing IVIG concerns
and to help craft effective solutions.
The intentions of the MMA changes were to rationalize how Medicare
pays for both Part B drugs and their administration, and also to create
options for physicians to either buy and bill for Part B drugs, or to
have those drugs furnished to a physician from a qualified vendor upon
submission of a prescription order. Payments for drug administration
codes have increased significantly from levels under the AWP payment
Studies by MedPAC, the Office of the Inspector General (OIG) and
the Government Accountability Office suggest that oncologists can
generally purchase drugs for the treatment of cancer at less than the
Medicare payment amount. Furthermore, the OIG study found that this was
true for both large and small practices. These studies suggest that the
ASP system has helped Medicare payments for oncology drugs covered
under Part B move closer to actual market prices. We are hopeful that
the initial success of the CAP program will encourage additional
The Department plans to continue monitoring payment for and access
to Part B drugs. CMS and other agencies within HHS are continuing to
work with manufacturers, providers, patient groups, and stakeholders to
ensure that patients receive appropriate and high quality care. I look
forward to answering any questions you may have.
Chairman JOHNSON OF CONNECTICUT. Mr. Vito.
STATEMENT OF ROBERT A. VITO, REGIONAL INSPECTOR GENERAL FOR
EVALUATIONS AND INSPECTIONS, U.S. DEPARTMENT OF HEALTH AND
Mr. VITO. Good afternoon, Madam Chairman. I am Robert Vito,
Regional Inspector General for Evaluations and Inspections at
the U.S. Department of Health and Human Services Office of
Inspector General. I appreciate the opportunity to appear
before you today to discuss our work regarding Medicare part B
reimbursement for prescription drugs. In the past, Medicare
part B reimbursed for most covered drugs based on their average
wholesale price, or AWP. However, this system was fundamentally
flawed, causing the Medicare Program and its beneficiaries to
overpay by hundreds of millions of dollars a year. To help
bring reimbursement more in line with the actual cost, Congress
created the average sales price, or ASP, methodology.
Unlike AWP, ASP is defined by law and based on actual sales
transactions. Recent data on Medicare expenditures show that
the move to ASP in January of 2005 has lowered inflated
reimbursement amounts. As a result, the part B expenditures for
drugs in 2005 fell by almost 1 billion from the previous year.
To help monitor the new reimbursement system, the MMA expanded
the OIG's role. The OIG was required to conduct a study on the
adequacy of ASP-based reimbursement amounts for cancer drugs as
well as to perform comparisons of ASP to other pricing points.
Through this we identified a small number of instances where
Medicare reimbursement may exceed certain prices in the
Our first study on ASP addressed the ability of physician
practices in three cancer-related specialties to obtain drugs
at 106 percent of ASP. We found that the average prices paid by
physicians for 35 of the 39 drugs we reviewed were less than
the ASP-based reimbursement amounts. Additionally, we found
that in most cases larger practices purchase drugs for less
than the smaller practices. The next three studies involved the
comparison of ASP to average manufacturer prices, or AMPs, and
ASP to widely available market prices, or WAMP. When the OIG
finds that the ASP of the drug exceeds the AMP or WAMP by 5
percent, the MMA gives the Secretary the authority to reduce
the Medicare reimbursement amount for the drug. In the first of
these comparisons we found for the first quarter of 2004 some
Medicare reimbursement for 51 of the 364 drugs included in our
review had an ASP that exceeded AMP by at least 5 percent. If
reimbursement for these 51 drugs had been lowered to 103
percent of AMP, Medicare expenditures would have been reduced
by an estimated 164 million in 2005.
Last week my office released a second report on the subject
finding that, for the second quarter of 2006 Medicare
reimbursement amounts, ASP exceeded AMP by at least 5 percent
for 46 of the 341 drugs reviewed. If its reimbursement amount
for the 46 drugs had been based on 103 percent of AMP, the
Medicare expenditures would have been reduced by 64 million in
1 year. The OIG also issued a report comparing ASP to WAMP for
a small number of drugs that we expected would meet the
criteria for the price reduction. We found that the prices for
five of the nine drugs we reviewed did indeed surpass the
threshold, with ASP exceeding WAMP by 17 percent to 185
percent. Medicare expenditures would be reduced as much as $67
million in 2006 if reimbursement amounts for these five codes
were lowered to the WAMP.
In addition to the mandated work I have described, we have
also issued a report on CMS's flawed methodology for
calculating ASP. This flaw stems from the fact the CMS does not
consistently weight the number of units of the drugs that were
sold in its calculation. As a result, in the first quarter of
2005, reimbursement amounts for 46 percent of the drugs were
too high, and reimbursement amounts for 13 percent of the drugs
were too low, leading to 110 million in excessive
reimbursements that year.
I want to conclude my testimony by stressing that the new
ASP system represents a marked improvement over the old AWP
methodology. Under this new system, we have seen a substantial
reduction in the reimbursement amounts for many products,
bringing a decade-long trend of increasing expenditures for
part B drugs to a halt. However, like any new reimbursement
system, we realize that its implementation must be continually
monitored to ensure that the payment levels are appropriate. To
this end we are committed through our oversight work to
continue to provide CMS and the Congress with timely
information on ASP-related issues. This concludes my testimony,
and I welcome your questions.
Chairman JOHNSON OF CONNECTICUT. Thank you, Mr. Vito.
[The prepared statement of Mr. Vito follows:]
Statement of Robert A. Vito, Regional Inspector General for Evaluations
and Inspections, U.S. Department of Health and Human Services
Good afternoon, Madam Chairman. I am Robert Vito, Regional
Inspector General for Evaluation and Inspections in Philadelphia at the
U.S. Department of Health and Human Services' Office of Inspector
General (OIG). I appreciate the opportunity to appear before you today
to discuss OIG's most recent work regarding Medicare Part B
reimbursement for prescription drugs and the average sales prices (ASP)
used to set this reimbursement.
In short, the new system appears to have lowered the previously
inflated Part B reimbursement amounts and, in turn, reduced overall
Medicare expenditures for prescription drugs. Even so, OIG's work has
identified a small number of instances in which the reported ASPs, and
the resulting Medicare reimbursement amounts, may still be higher than
certain other prices in the marketplace. We have also identified an
issue with the method CMS uses to calculate reimbursement amounts.
Flaws in the Previous Reimbursement System
Prior to 2004, Medicare Part B reimbursed for most covered drugs
based on the lower of either the billed amount or 95 percent of the
average wholesale price (AWP) as published in national pricing
compendia. The AWP is not defined by law or regulation, nor is it
typically based on actual sales prices. As numerous reports by OIG and
the Government Accountability Office have illustrated, the AWP-based
reimbursement amounts for most covered drugs were significantly higher
than the prices that drug manufacturers, wholesalers, and other similar
entities actually charged the physicians and suppliers who purchase
these drugs. Consequently, under this flawed system, the Medicare
program and its beneficiaries were overpaying by hundreds of millions
of dollars per year for prescription drugs.
To help align reimbursement amounts with actual acquisition costs,
Congress included in the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) provisions to reform Part B drug
reimbursement. The MMA specified that reimbursement amounts for most
outpatient prescription drugs furnished in 2004 be set at 85 percent of
the AWP, until a new methodology could be implemented on January 1,
2005. This new methodology based reimbursement amounts on manufacturer-
reported ASPs rather than AWPs. Unlike the AWP, an ASP is defined by
statute and based on actual sales transactions. The MMA defines an ASP
as a manufacturer's sales of a drug to all nonexempt purchasers in the
United States in a calendar quarter divided by the total number of
units of the drug sold by the manufacturer in that same quarter. The
ASP is net of any price concessions such as volume, prompt pay, and
cash discounts; free goods contingent on purchase requirements;
chargebacks; and rebates other than those paid under the Medicaid drug
rebate program.\1\\,\ \2\ Under this new methodology, Medicare
reimbursement for most Part B drugs is set at 106 percent of the drugs'
\1\ Section 1847A(c) of the Social Security Act, as added by the
\2\ Pursuant to section 1847A(c)(2) of the Social Security Act,
sales that are nominal in amount are exempted from the ASP calculation,
as are sales excluded from the determination of ``best price'' for
Medicaid drug rebate purposes.
\3\ Although manufacturers submit an ASP and sales volume for each
individual drug product they sell, CMS does not establish a
reimbursement rate for each specific drug product. CMS uses ASP data
for individual drug products to calculate an overall ASP for the
procedure code. The ASP for an individual drug product is weighted by
the amount of that drug sold during the quarter. This means that the
ASP for a drug with a high volume of sales should have greater
influence on the reimbursement amount for a procedure code than an ASP
for a drug with a low volume of sales.
Impact of ASPs On Medicare Reimbursement
The Congressional Budget Office estimated that the changes enacted
by the MMA would save Medicare almost $16 billion over 10 years by
reducing excessive Medicare reimbursement amounts for Part B-covered
drugs. Recent data on Medicare reimbursement and expenditures provide
evidence confirming that the ASP-based reimbursement system has
substantially lowered reimbursement amounts for numerous drugs. For
about one-quarter of the drugs covered under Part B, Medicare
reimbursement amounts have been reduced by at least 50 percent when
compared to pre-MMA levels. For example, in 2003 \4\ (when
reimbursement was set at 95 percent of the AWP), Medicare paid almost
$120 for a month's supply of the inhalation drug albuterol; today,
Medicare pays $20.\5\ For the cancer drug Zoladex, Medicare paid almost
$450 per dose in 2003; Medicare currently pays $196 per dose.
\4\ All data and methods described in the testimony refer to
\5\ These figures relate only to reimbursement for the drugs
themselves. They do not include the dispensing fees paid to the
The reductions in the reimbursement amounts for individual drugs
have had a substantial effect on overall Part B expenditures. Before
the MMA was enacted, CMS data indicated that Medicare expenditures for
Part B drugs had increased by at least 20 percent annually every year
since 1994. By 2004, Medicare was paying almost $11 billion for covered
drugs, up from $4 billion just 6 years earlier. Due to changes made by
the MMA, this trend has reversed, with Medicare Part B spending close
to $1 billion less on covered drugs in 2005 than in 2004. This decrease
occurred despite rising utilization for the drugs.
OIG Work Involving Medicare Part B Drugs
Prior to the passage of the MMA, OIG's primary role in Medicare
drug pricing involved identifying and reporting on flaws in the AWP-
based system that left the program vulnerable to fraud, waste, and
abuse. In more than a dozen reports, we repeatedly found that Medicare
paid too much for prescription drugs due to inflated AWPs. In addition,
working with our many law-enforcement partners, we assisted in
investigations of pricing issues that resulted in significant civil and
The MMA established two mandates for OIG that changed and expanded
our role in monitoring Medicare drug pricing. First, the MMA mandated
that OIG conduct a study on the adequacy of ASP-based reimbursement
amounts for certain cancer drugs. Second, the MMA required OIG to
perform an ongoing monitoring function that compares ASPs to other
pricing points. As discussed below, we have recently completed studies
that address both of these mandates.
OIG Work Required by the MMA
Adequacy of ASP-Based Reimbursement for Certain Cancer Drugs
The MMA required that OIG conduct a study on the ability of
physician practices of different sizes in the specialties of
hematology, hematology/oncology, and medical oncology to obtain drugs
and biologicals at 106 percent of the ASP. This requirement responded
to concerns that the new reimbursement amounts based on ASPs may be
lower than the drug acquisition costs for physicians in these
specialties. OIG completed this study in September 2005.\6\
\6\ ``Adequacy of Medicare Part B Drug Reimbursement to Physician
Practices for the Treatment of Cancer Patients,'' A-06-05-00024.
We compared the average prices paid by physicians for drugs
represented by 39 procedure codes to Medicare reimbursement amounts and
concluded that physician practices in the three specialties could
generally purchase drugs for the treatment of cancer patients at less
than the MMA-established reimbursement rates (i.e., 106 percent of the
ASP). Overall, the report found that the average prices paid for 35 of
the 39 drugs under review were less than the Medicare reimbursement
amounts. Larger physician practices purchased drugs at greater
discounts (i.e., at least 15 percent below Medicare reimbursement) for
more drugs than smaller practices. In addition, we also estimated that
for 35 of the 39 codes, physician practices could purchase drugs for
less than the reimbursement amounts during at least half of the months
OIG Comparisons of ASPs to Other Pricing Points
The MMA also mandated that OIG conduct studies that determine
whether the ASP exceeds certain other prices. Specifically, the MMA
required OIG to compare manufacturer-reported ASPs to both average
manufacturer prices (AMP) \7\ and widely available market prices
(WAMP).\8\ In certain situations where the ASP of a drug exceeds the
AMP or the WAMP by a certain threshold, the MMA gives the Secretary the
authority to reduce the reimbursement amount for the drug to either 103
percent of the AMP or 100 percent of the WAMP. Currently, the threshold
amount is 5 percent, although the Secretary has the authority to raise
or lower this percentage in the future.
\7\ AMPs, also reported by drug manufacturers to CMS, are used in
the determination of rebates in the Medicaid program. As defined in
section 1927(k)(1) of the Social Security Act, the AMP is the average
price paid to the manufacturer for the drug in the United States by
wholesalers for drugs distributed to the retail pharmacy class of
trade, minus customary prompt pay discounts.
\8\ Section 1847A(d)(5) of the Social Security Act generally
defines widely available market price to be the price that a prudent
physician or supplier would pay for the drug, net of any routinely
available price concessions.
Comparisons of ASPs to AMPs. OIG completed the first of
its studies comparing ASPs to AMPs and issued a report earlier this
year.\9\ We found that in the third quarter of 2004, 51 of the 364
procedure codes (14 percent) included in this review had an ASP that
exceeded the AMP by at least 5 percent. If reimbursement amounts for
these 51 codes had been lowered to 103 percent of the AMP, Medicare
expenditures would have been reduced by an estimated $164 million in
\9\ ``Monitoring Medicare Part B Drug Prices: A Comparison of
Average Sales Prices to Average Manufacturer Prices,'' OEI-03-04-00430,
In response, CMS stated that the information in the report was
helpful in its continuing efforts to monitor payment adequacy under the
ASP methodology. However, CMS noted that OIG's review was conducted
using data submitted during the initial implementation phase of the ASP
methodology. Although CMS acknowledged the Secretary's authority to
adjust ASP payment limits when certain conditions are met, it believed
that other factors should be considered, including the timing and
frequency of pricing comparisons, stabilization of ASP reporting, the
effective date and duration of rate substitution, and the accuracy of
ASP and AMP data.
In June 2006, OIG released a second report comparing ASPs to
AMPs.\10\ We found that for 46 of the 341 procedure codes (13 percent)
included in this review, ASPs exceeded AMPs by at least 5 percent in
the fourth quarter of 2005.\11\ Twenty of these codes were identified
in OIG's previous report as having ASPs that exceeded AMPs by at least
5 percent in the third quarter of 2004. If reimbursement amounts for
the 46 codes had been based on 103 percent of the AMP, we estimate that
Medicare expenditures would have been reduced by $64 million in one
\10\ ``Comparison of Fourth Quarter 2005 Average Sales Prices to
Average Manufacturer Prices: Impact on Medicare Reimbursement for the
Second Quarter of 2006,'' OEI-03-06-00370.
\11\ Fourth-quarter 2005 ASPs are used to set second-quarter 2006
Comparison of ASPs to WAMPs. In addition to the
comparisons of ASPs and AMPs, OIG released a report comparing ASPs to
WAMPs in June 2006.\12\ For this analysis, we specifically selected a
purposive sample of nine procedure codes for which we suspected that
the ASP might exceed the WAMP by at least 5 percent. The purposive
sample was based on the results of the September 2005 OIG report on
adequacy of reimbursement for cancer drugs.
\12\ ``A Comparison of Average Sales Prices to Widely Available
Market Prices: Fourth Quarter 2005,'' OEI-03-05-00340.
We found that 5 of the 9 procedure codes included in this review
met or surpassed the 5-percent threshold defined by the MMA. For these
5 codes, the ASPs exceeded the WAMPs by a range of 17 to 185 percent.
We estimate that Medicare expenditures would be reduced by as much as
$67 million in 2006 if reimbursement amounts were lowered to the WAMPs
for these 5 codes. In addition, the prices that physicians pay for
these drugs may be even lower than the WAMPs that were calculated, as
all of the responding distributors offered price discounts to physician
customers that were not reflected in the calculation of WAMPs.\13\
\13\ The most common type of price discount offered to physician
customers was a prompt pay discount. Three of the five companies that
responded to our request for information offered this type of
incentive, with percentage discounts ranging from 1 to 3 percent,
depending on the time of payment.
Additional OIG Work Involving ASP
CMS's Calculation of ASPs
For the most part, the Medicare Part B reimbursement amount for a
drug is now based on a volume-weighted ASP that CMS derives from the
underlying ASPs for individual drug products reported by manufacturers.
In the process of conducting the mandated price comparisons, we
identified a problem with the method CMS uses to calculate volume-
weighted ASPs. We alerted CMS to the problems with its calculation and
issued a report on this subject in February 2006.\14\ We found that
CMS's method for calculating a volume-weighted ASP is mathematically
flawed because CMS does not consistently weight the number of units of
a drug that were sold throughout its equation. As a result, many
procedure codes have a reimbursement amount that is higher or lower
than the amount that would have been calculated if the weighting were
\14\ ``Calculation of Volume-Weighted Average Sales Price for
Medicare Part B Prescription Drugs,'' OEI-03-05-00310.
According to OIG's analysis of prices published in the first
quarter of 2005, the flawed calculation caused 46 percent of procedure
codes to be reimbursed at amounts that were higher than they should
have been, resulting in an estimated $115 million in excessive Medicare
reimbursements in 2005. For 13 percent of procedure codes, CMS's
reimbursement amount was lower than it should have been, representing
an estimated $5 million loss to providers in 2005. The flawed
calculation did not affect reimbursement amounts for the remaining 41
percent of procedure codes. OIG recommended that CMS change its
calculation of volume-weighted ASPs. Although CMS stated that it may
consider altering the ASP methodology in the future, the agency has yet
to make any changes to its calculation of volume-weighted ASPs.
Drug Manufacturers' Calculations of ASPs
OIG is currently auditing eight drug manufacturers to evaluate
their methodologies for calculating ASPs for individual drug products.
Several more audits are planned in the near future.
Adequacy of Reimbursement for Intravenous Immune Globulin
This Subcommittee and the House Committee on Energy and Commerce
Subcommittee on Health requested that OIG evaluate the current state of
pricing and supply for one specific drug, intravenous immune globulin
(IVIG). Patient advocacy groups and physicians have repeatedly
expressed concerns that, under the ASP-based reimbursement methodology,
the cost for physicians to acquire IVIG exceeds Medicare's
reimbursement amount. OIG's work in this area is ongoing. A final
report that addresses Medicare reimbursement for IVIG, provides
perspectives on the supply and distribution of this unique product, and
makes any recommendations that are warranted will be issued in the near
Dispensing Fees for Inhalation Drugs
In tandem with the reimbursement reductions resulting from the MMA,
CMS raised the dispensing fee paid by Medicare in 2005 for inhalation
drugs from $5 to an interim amount of $57 for a 30-day drug supply. It
did so based in large part on industry statements claiming that
beneficiaries receive numerous, important services from their
suppliers. Last year, OIG issued a report that reviewed the nature and
extent of dispensing services that Medicare beneficiaries received from
inhalation drug suppliers in 2003. OIG found that the most common
service beneficiaries received was contact for drug refills. Few
beneficiaries received more intensive services such as education, care
plan revision, or a respiratory assessment, and 16 percent of
beneficiaries received no services at all. The most common way
beneficiaries received services was by telephone; only 1 in 10
beneficiaries received a home visit.
Prior to the passage of the MMA and the implementation of the new
ASP-based methodology, Medicare reimbursed for many prescription drugs
at prices that did not reflect actual acquisition costs for physicians
and suppliers. Under the new system, there has been a substantial
reduction in reimbursement amounts for many high-dollar products,
causing the decade-long trend of increasing Part B expenditures for
prescription drugs to reverse. Building on OIG's existing work that
identified weaknesses in the old system, we have responded to new
mandates under the MMA by taking on a more extensive role in helping to
ensure the appropriateness of Medicare payments under the new
methodology. As a result, OIG has already identified a few instances
where the reported ASPs, and the resulting Medicare reimbursement
amounts, may still be higher than certain other prices in the
marketplace. In addition, OIG has undertaken nonmandated audits and
evaluations of issues that we have identified as important to ensuring
the integrity of Medicare Part B drug payments, such as the methodology
used by CMS to calculate Medicare reimbursement amounts, and the
methodologies used by drug manufacturers to calculate ASPs.
It appears that the new ASP methodology represents a marked
improvement over the old AWP system. However, like any new
reimbursement system, we realize that its implementation must be
continually monitored to ensure that payment levels are appropriate. To
this end, we are committed through our oversight work to provide CMS
and Congress with timely information regarding ASPs and other drug
This concludes my testimony, and I welcome your questions.
Chairman JOHNSON OF CONNECTICUT. Dr. Miller.
STATEMENT OF MARK MILLER, PH.D., EXECUTIVE DIRECTOR, MEDICARE
PAYMENT ADVISORY COMMISSION
Mr. MILLER. Chairman Johnson, Ranking Member Stark and
distinguished Subcommittee Members, I am Mark Miller, Executive
Director of the Medicare Payment Advisory Commission. I will
apologize here. I think you are going to hear some things that
you have already heard. Medicare part B, that pays for--part B
drugs that are used to treat patients with very serious medical
conditions such as cancer, hemophilia and rheumatoid arthritis.
Under Medicare's old system, the AWP, Medicare expenditures
were growing rapidly at annual rates of 20 and 25 percent. This
is because AWP was inflationary and paid well above what
physicians paid to purchase the drug. Physicians argued that
they needed this spread in order to cover the cost of
administering these drugs.
The MMA changed both the way that Medicare pays for the
drug as well as the way physicians are paid to administer
drugs. The new system, the ASP, has resulted in substantially
lower Medicare expenditures. As you have just heard, in 2005
there was actually a reduction in expenditures. This is because
Medicare has realized lower prices for these drugs. For
example, we looked at the volume and mix of drugs provided in
2004 under the old payment system and determined that if they
had been paid under the new payment system, Medicare would have
paid 22 percent less.
Congress asked MedPAC to examine the impact of these policy
changes on oncology practices and on Medicare beneficiaries
receiving cancer treatments. Before I go through these results,
I want to make one caveat. We were asked to report in January
of 2006, which we did, but, of course, many of the policy
changes were still coming into effect. We analyzed national
claims data. We made several site visits to communities to talk
to oncology offices, to outpatient departments, hospitals,
physicians, and we also ran focus groups on beneficiaries. This
is what we found. The volume of services going to beneficiaries
continued to increase after the implementation of the policies.
Between 2004 and 2005, cancer chemotherapy sessions in
physicians' offices increased by 13 percent. The number of
beneficiaries receiving cancer chemotherapy sessions increased
by at least 7\1/2\ percent. As you have already heard
mentioned, the actual Medicare reimbursements to support the
administration of the drugs increased significantly over those
There is also a long-running trend in the provision of
these services toward the use of the latest drugs in order to
give patients new options to treat their cancer. These drugs,
because they are new, are often very expensive. That trend
continued after the implementation of the policies. So, all of
these data don't point to the lack of access problem, but there
is one issue I want to bring to your attention. In a couple of
the communities that we visited, we found that beneficiaries
who did not have supplemental insurance were being referred to
hospital outpatient departments for the infusion of their drug.
The issue breaks down like this. If the physician gets
reimbursed for cancer chemotherapy drugs, the physician is
getting a payment from the program and from the beneficiary. If
the beneficiary is unable to make that payment, the physician
may determine that they can't afford to purchase that drug,
send the patient to the outpatient department for the infusion,
and bring them back to the office for the remainder of their
So, there is no access issue per se. The beneficiary still
gets the infusion, but there is clearly a convenience issue and
other issues that attach here, of program payment issues as
well. Practices were able to purchase most Medicare--most, not
all--but most Medicare drugs at or below Medicare's payment
rate. Oncologists did change the organization of their
practices. They hired staff and engaged in more aggressive
price negotiation tactics, and also kept lower inventory in
order for them to take advantage of changes in prices.
I will conclude my testimony by saying we think that ASP is
not a perfect payment system, as well as some of the other
statements that were made here, but we think it is a vast
improvement over the AWP, and also, like you have heard, we
believe it needs continued monitoring in order to be sure that
the prices--prices are tracking the payment, the prices that
physicians are actually paying to get the drug. I look forward
to your questions.
Chairman JOHNSON OF CONNECTICUT. Thank you, Mr. Miller.
[The prepared statement of Mr. Miller follows:]
Statement of Mark Miller, Ph.D., Executive Director, Medicare Payment
Chairman Johnson, Ranking Member Stark, distinguished Subcommittee
members. I am Mark Miller, executive director of the Medicare Payment
Advisory Commission (MedPAC). I appreciate the opportunity to be here
with you this morning to discuss MedPAC's work on Medicare Part B drugs
Before 2006, Medicare covered few outpatient drugs but those
medications that were covered under Part B were used to treat patients
with very serious medical conditions like cancer, hemophilia, and
rheumatoid arthritis. Medicare expenditures for these drugs were
growing rapidly, rising from $2.8 billion in 1997 to $10.3 billion in
2003, representing about 4 percent of Medicare spending. Although
policymakers agreed that payment rates for Part B drugs were too high,
providers argued that the high rates were necessary to offset drug
administration fees that were too low to cover the costs of
administering those drugs to beneficiaries.
The Medicare Prescription Drug, Improvement, and Modernization Act
(MMA) changed the way Medicare pays for both drugs and drug
administration services under the physician fee schedule. As intended
by the policy, payment rates for drugs were reduced to levels closer to
the prices providers were paying while payment rates for drug
administration increased. As a result of the payment changes, Medicare
spending for Part B drugs declined in 2005 despite increases in the
volume of drugs used and the substitution of newer drugs for older less
The Congress directed MedPAC to study the effect of these changes
on beneficiary access and quality of care. Our first report, completed
January 2006, focused on services provided by oncologists. We found
that, in general, beneficiary access to chemotherapy drugs remained
good and we found no evidence that quality of care declined. For our
second mandated report, due in January 2007, we are studying the
effects of the payment changes on drug administration services provided
by other specialties, such as urologists and rheumatologists.
Although no payment system is without drawbacks, the current system
has resulted in Medicare payments that are closer to the price
physicians pay and has reversed spending trends for Part B covered
drugs. However, the Commission believes that it is important for the
Secretary to continue monitoring physician acquisition costs to test
the accuracy of Medicare drug payments as the new payment system
evolves over time.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Chart 1. Medicare spending and annual growth rates for Part B drugs.
Source: MedPAC analysis of CMS data, 1997-2004
Under Part B, Medicare covers drugs administered in physician
offices, including drugs used for chemotherapy, drugs used as part of
durable medical equipment, blood clotting factor, erythropoietin used
to treat anemia in end-stage renal disease patients and cancer
patients, and some oral medications such as immunosuppressive drugs
used following organ transplants. These drugs are not usually purchased
at retail pharmacies. Providers buy the products and then bill Medicare
as they administer them to patients. Physician claims account for the
majority of Medicare expenditures for Part B outpatient drugs.
Physicians in only two specialties--hematology oncology and medical
oncology--submitted claims for almost 50 percent of total billing for
Part B drugs in 2004, not including drugs provided in dialysis
Expenditures for Part B drugs increased rapidly, more than 25
percent every year from 1998 to 2003. One of the most significant
factors driving spending growth was the payment method. Following the
Balanced Budget Act (BBA) of 1997, the Medicare payment rate for
covered drugs was set at 95 percent of the average wholesale price
(AWP). Despite its name, AWP does not represent the average wholesale
price. Rather, it can be thought of as a manufacturer's suggested list
price. It does not have to correspond to any transaction price or
average transaction price, which often reflect substantial discounts.
Every drug has its own AWP. Individual AWPs are compiled and reported
in compendia like the Red Book and First Databank largely on the basis
of information supplied by the manufacturers. A series of
investigations by the Department of Health and Human Services Office of
the Inspector General (OIG) and the Government Accountability Office
(GAO) showed that Medicare payment rates were well above providers'
Policymakers discussed a number of ways to reform the payment
system, including continuing to pay based on AWP but requiring a
steeper discount, setting payment to a different benchmark tied to
transaction prices like the average sales price (ASP) or the average
acquisition price (AAP), or using competitive bidding to lower prices.
In its June 2003 Report to Congress, the Commission examined these
Our analysis suggested that continuing to use AWP as a benchmark
but requiring steeper discounts would lead to limited savings for
Medicare. In many cases, the additional discount would still result in
payments substantially higher than acquisition costs. AWP would still
not correspond to any transaction price and could not be audited.
Providers would continue to have an incentive to switch to drugs with
higher AWPs to maximize their profit.
Next, we examined the potential effects of a payment method based
on a computed average transaction price such as the average sales price
(ASP), or the average acquisition price (AAP). Both of these methods
depend upon calculated average transaction prices for products.
Although in theory calculations based on ASP and AAP should result in
the same payment rate, ASP is based on data collected from
pharmaceutical manufacturers while AAP data is collected from
physicians and suppliers. Differences might reflect inclusion of the
wholesalers' fees in AAP and differences in the way manufacturers and
physicians would report the data. Since manufacturers are already
reporting average price data to CMS in order to determine Medicaid drug
payment rates, the data needed to calculate ASP is more readily
available than the data needed to determine the average acquisition
We concluded that a competitive system or use of either benchmark
(ASP or AAP) would reduce Medicare payments. We recognized that there
were drawbacks to every proposed reform of the payment system but that
all options were likely to reduce Medicare payments compared to the AWP
system then in place.
All proposals based on these benchmarks anticipated paying
providers a specified percentage above the calculated price although
they differed as to how high to set the additional payment. The
Commission did not recommend that the payment rate be set at any
specific percentage above the benchmark. We said that beneficiary
access would not be affected as long as the payment rate was set high
enough to meet the costs of efficient providers. We also said that
payments set too high above the benchmark would encourage price
increases and reduce Medicare savings.
Following passage of the MMA, Medicare significantly changed the
way it pays providers for physician-administered drugs and drug
administration services, generally reducing the payment rate for drugs
while increasing payments for drug administration services. In 2005,
Medicare began paying for Part B drugs based on 106 percent of the
average sales price (ASP). ASP represents the weighted average of
manufacturers sales prices for each product that falls within a
Medicare billing code. (Medicare billing codes are used for multiple
products.) It is based on data submitted quarterly by pharmaceutical
manufacturers, net of price concessions such as rebates and discounts
and is limited to sales in the United States. The ASP payment rate is
set prospectively based on these transaction prices from two quarters
prior. Thus, if manufacturers raise prices in the succeeding quarters,
purchasers may have difficulty purchasing products at the Medicare
payment rate until the ASP ``catches up.'' On the other hand, if prices
go down, either because of competition between therapeutically
equivalent branded drugs or because a generic version of a branded drug
becomes available, purchasers may buy products at prices significantly
below the payment rate until the ASP ``catches up.''
Concerned that the payment changes not affect beneficiary access to
needed medical care, the Congress directed the Commission to complete
two studies on the effects of the new payment system on beneficiary
access, quality of care, and physician practices. Our first report,
delivered January 2006, analyzed the effect of the payment changes on
beneficiary access to chemotherapy. We are currently conducting a
second study on the effect of the payment changes on services provided
by other specialties including urologists, rheumatologists, and
infectious disease specialists.
Because the legislated changes had not yet been fully implemented
and we only had partial data for 2005, the Commission had limited
ability to analyze the impact of the changes. We undertook a series of
qualitative and quantitative analyses to assess beneficiary access and
quality of care.
We analyzed expenditures and changes in volume for
chemotherapy services using Medicare claims data.
We analyzed a commercial database with prices for drugs
used by oncologists to see if prices physicians paid were below the
Medicare payment rates, and we measured the variation in prices
different physician practices paid.
We visited community oncologists, hospital outpatient
departments, and health plans in five markets to discuss the effects of
payment changes on practices.
We conducted four focus groups with Medicare
beneficiaries receiving chemotherapy during 2005 to see how the payment
changes affected their experiences.
We interviewed stakeholders to gain their perspective on
how the payment changes affected the buying and selling of physician-
Finally, we reviewed the literature on pricing for Part B
drugs and studies of quality-of-care indicators for chemotherapy.
We found that the payment changes did not affect beneficiary access
to chemotherapy services. Physicians provided more chemotherapy
services and more Medicare beneficiaries received services in 2005 than
in 2004. We saw no indication that quality of care was affected, and
patients continue to be satisfied with the care they are receiving. We
found no indication of access problems in any region of the country. In
general, large practices were able to purchase chemotherapy drugs at
lower prices than small practices, but all could buy most drugs at
prices below the Medicare payment rate. However, there is one issue to
report. In some areas, beneficiaries without supplemental insurance
were receiving chemotherapy in hospital outpatient departments rather
than physician offices.
Medicare spending on chemotherapy drugs and services
To measure the impact of the 2005 Medicare payment change to ASP,
we analyzed carrier claims for the first six months of 2005. We
compared our results to spending and volume claims for the same period
in 2003 and 2004. We found that beneficiaries received more drug
administration services in 2005 than 2004, but that spending remained
constant. Medicare expenditures for chemotherapy drugs declined in 2005
because of the change to payment based on ASP. The change to pricing
based on ASP also narrowed the gap between the prices paid by the
providers who negotiated the best and worst deals with drug
Preliminary estimates by CMS indicate that spending for all Part B
drugs in 2005 declined by 3 percent. Drug spending is determined by
volume, drug mix, and the payment rate for the drugs. In the case of
Part B drugs, volume increases were offset by changes in the payment
To demonstrate the effect of pricing changes from 2004 to 2005, we
estimated what Medicare would have paid if the volume of all the
specific Part B drugs billed in 2004 were paid according to the
Medicare payment rates for October 2005. Using this methodology, we
calculated that expenditures for all Part B drugs used in 2004 would
have cost 22 percent less in 2005.
However, the spending decrease was not as great as the decrease in
prices would have suggested because the mix of drugs used in 2005 was
different from the mix used in 2004. In a continuation of previous
trends, physicians substituted newer, more expensive single source
drugs for older drugs. Many of the new drugs are produced through the
use of biotechnology. Not only are these products expensive when
initially marketed, they face only limited competition over time
because the FDA does not yet have an approval process for generic
versions of biologicals. Many of these biologicals are used in the
treatment of cancer. Of the ten drugs that accounted for the largest
share of Part B drug spending, four received FDA approval in 1996 or
later. Additionally, spending on injectables too new to have received
their own payment codes accounted for 3 percent of Part B drug
Both the volume and payments for chemotherapy administration
increased in 2005. We estimate that physicians provided 13 percent more
chemotherapy sessions in 2005 than in 2004. CMS changed its rules to
allow physicians to bill more codes for each chemotherapy session, so
the number of services has increased faster than the number of
sessions, by 33 percent from 2003 to 2005. In addition, the Congress
made two, one-year payment increases for drug administration: in 2004
it increased payments by 32 percent and in 2005 it increased payments
by 3 percent over what would otherwise be paid under the fee schedule.
Taken together, the volume and payment increases led spending for
chemotherapy administration services to rise 182 percent from 2003 to
We also compared the number of Medicare beneficiaries receiving
chemotherapy in physician offices in 2003, 2004, and 2005. We estimate
that the number of beneficiaries receiving chemotherapy in physician
offices increased 7.5 percent in 2005, based on the most conservative
assumption. No matter what set of assumptions we used, Medicare
beneficiaries received an increasing number of chemotherapy sessions in
physician offices from 2003 to 2005.
In 2005, CMS provided another source of payments for chemotherapy
in physician offices. In addition to paying for drugs and drug
administration services, CMS implemented a one-year demonstration
project to evaluate how chemotherapy affects the level of fatigue,
nausea, and pain experienced by patients. All oncologists were eligible
to receive $130 per patient per day for asking chemotherapy patients
three questions about how they had responded to treatment.
(Beneficiaries were charged $26 copayments for this demonstration.) We
estimate that this demonstration project increased Medicare
expenditures by more than $200 million, further increasing drug
administration payments by more than 70 percent over 2003 levels. (In
2006, CMS implemented an alternative demonstration project. The agency
required oncologists to provide information on treatment patterns for
patients with different cancers at different disease stages. Physicians
reporting the required data receive $23 per patient visit.) The
addition of the demonstration project funds complicated MedPAC's
ability to evaluate fully the effects of the payment changes.
In the course of our site visits, the Commission found that most
oncologists could purchase most drugs at rates below the Medicare
payment level, but profit margins on these drugs generally were low, as
the policy change anticipated. Every practice reported that that they
could not buy some drugs at the payment rate. A study by the Office of
Inspector General (OIG) (September 2005) indicated that oncologists
could still purchase most drugs at rates below the payment level,
although specific drugs posed a problem for some practices. In general,
larger practices paid lower prices than smaller practices for the same
The Commission analyzed the data presented in the OIG report to
determine what kinds of drugs provided higher or lower payment margins
compared to the Medicare payment rates. We found that the highest
payment margins occurred when generic alternatives, such as carboplatin
and cisplatin, became available. Purchasers also were able to buy brand
name drugs at prices well below Medicare payment rates if the drugs had
therapeutic substitutes available. One example would be dolasetron
mesylate, one of a number of drugs used to treat nausea in chemotherapy
As providers moved to purchase less costly alternatives,
competition between buyers and sellers resulted in lower Medicare
payment rates in the following quarters. We found that when the January
Medicare payment rate for a drug was more than 15 percent higher than
the average price providers paid, the Medicare payment rate fell
sharply by October. In particular, payment rates for chemotherapy drugs
with high margins in January declined by as much as 72 percent in
Changes in both pricing and purchasing patterns may affect the
accuracy of drug payments over time. For this reason, the Commission
has recommended that the Secretary continue to monitor provider drug
acquisition costs in both physician offices and dialysis facilities.
Under the ASP method, pharmaceutical manufacturers might narrow the
range of discounts offered to purchasers to ensure that all physicians
could purchase their products at the Medicare payment rates. Since the
market for chemotherapy drugs is limited, manufacturers would want to
maximize their customer base. To track changes in oncology prices over
time, the Commission acquired pricing information from a commercial
data source. (Our contract with the vendor does not allow us to present
prices for specific drugs.) Prices are net of discounts but do not
include rebates provided by manufacturers after the sale. The database
shows variation between the lowest and highest prices the purchaser
paid. The Commission purchased data on 26 drugs billed by oncologists
for one month of each of the first three quarters of 2005. Drugs
include chemotherapy agents and medications used to treat the side
effects of chemotherapy. Many overlap with the drugs identified in the
OIG report. The 26 drugs accounted for more than 50 percent of
physician-administered Part B drug spending in 2004.
Our analysis of prices paid by physicians showed that price
variation for our basket of drugs declined between the first and third
quarters of 2005. Next, we looked to see if the decline in price
variation was more pronounced for any particular types of drugs. We
grouped our drugs in two ways. First, we classified them based on
whether they were single source branded drugs or had generic
alternatives. Next, we looked at whether the drugs were chemotherapy
agents or prescribed to treat the side effects of chemotherapy. For all
four categories, the range, defined as the variation between the best
and worst price obtained by physicians, narrowed between the first and
third quarters of 2005. The range for single source chemotherapy
drugs--small to begin with--narrowed least, falling from 6.9 percent to
5.2 percent. The biggest change was in the range for drugs used to
treat the side effects of chemotherapy. That range declined 25.3
percent in the first quarter to 10.3 percent third quarter (chart 2).
In other words, for this group of drugs there was a difference of about
10 percent between the highest and lowest prices available to
Chart 2. Change in price variation by chemotherapy and non-chemotherapy
June 2005-December 2004
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Note: Two drugs have been excluded because generic alternatives
became available during the four quarters. Two others have been
excluded because of crosswalk problems. The range measures the percent
of variability among the prices paid by clinics. It is measured by
subtracting the price paid by the 25th percentile from the price paid
by the 75th percentile, dividing by the price paid by the 50th
percentile, and multiplying by 100. MedPAC's contract with IMS Health
does not allow the prices of drugs be named individually.
Source: MedPAC analysis of IMS Health data 2004-2005.
Changes in physician practices
The Congress required the Commission to examine the effect of the
payment changes on physician practices. During our site visits, we
asked physicians how they responded to the Medicare payment changes. Of
course, their answers were subjective. Physicians told us they
considered the payment changes significant and changed their practices
to get better drug prices, lower costs, and boost revenue. All
practices changed their drug purchasing activities. Some also changed
their use of drugs, office staffing, mix of services offered, and
All the physicians we visited reported that they spent more time
and resources shopping for lower prices for drugs than they did before
the payment changes. Their choice of ancillary drugs for treating
chemotherapy side effects was more likely to be based on price. Many
practice managers reported that they routinely purchased only one drug
to treat nausea and one erythroid growth factor to treat anemia for all
the physicians in the practice. Physicians also reported that they kept
smaller inventories of drugs on hand than previously. This allowed them
to respond quickly to price changes and avoid tying up large sums of
Many offices have hired employees to work with patients when they
begin treatment to ensure that they can pay their out-of-pocket
expenses. This financial adviser estimates the beneficiary's potential
liability based upon the treatment plan. If the beneficiary does not
have supplemental insurance, the adviser determines whether she
qualifies for other assistance, including Medicaid and assistance
programs maintained by individual pharmaceutical manufacturers. The
beneficiary may be given a payment schedule to make copayments over
Practices reported that differences in local coverage policies
affected their treatment decisions. Physicians were reluctant to use
expensive new therapies that they thought the local carrier might not
cover. For example, a carrier might cover a new drug for treatment of
one cancer while the physician wanted to use it to treat a patient with
another type of cancer. One practice reported sending a patient to the
hospital outpatient department for treatment because the local
intermediary covered a particular drug and the carrier did not.
Practices reported they were less likely to appeal local coverage
decisions. They found the appeals process too expensive and time-
consuming and the outcome of the appeal uncertain.
Physicians took other actions to reduce costs or improve
efficiency. For example, some practices reduced costs by changing their
mix of employees, replacing full-time employees with part-time
employees or replacing nurses with pharmacy technicians. Similarly,
many practices reported that they reduced health and pension benefits
for their employees. One practice reported increasing efficiency by
hiring workers to do the coding for oncology nurses and freed up their
time for patient care. Several practices reported hiring a pharmacist
to purchase and mix drugs as well as recommend drugs to the practice
based on price and clinical effectiveness.
Some practices tried to increase revenues by providing more
services in their offices. For example, some physician practices
purchased positron emission tomography (PET) scanning technology in the
past few years and increased imaging in their offices. However, this
was only possible for practices with large facilities. Many practices
reported they did not have the space or capital to expand in this way.
No physician or office manager reported that the payment changes
affected the quality of care in their office. No beneficiary who
participated in our focus groups reported that she had seen a decline
in the quality of care she was receiving.
Beneficiaries without supplemental insurance
While the new Medicare payment system has reduced prices for
existing drugs, it does not have any mechanism to affect prices for new
single source branded drugs as they enter the market. New products have
become increasingly expensive in the past few years. Beneficiary
copayments for these drugs (20 percent of the total payment) are high,
and physicians who cannot collect coinsurance from beneficiaries will
receive only 80 percent of the Medicare payment rate. Medicare has no
limit on the out-of-pocket costs that beneficiaries may face. Medicare
beneficiaries without supplemental coverage may be transferred to
hospital outpatient departments (HOPDs) and face higher copayments
there. However, if beneficiaries who cannot pay cost sharing in
physician offices go to HOPDs for chemotherapy infusion, they are
unlikely to be able to pay the higher cost sharing there. Instead,
their unpaid bills would become bad debt. Medicare pays 70 percent of
hospitals' bad debt.
Although we did not find any cases in which beneficiaries could not
get chemotherapy services, Medicare beneficiaries without supplemental
insurance have more limited choices in some areas of the country. These
individuals are more likely than other beneficiaries to receive
chemotherapy in HOPDs. In 2004, the Commission found that in some
markets, oncology practices had stopped treating Medicare patients
without supplemental insurance in their offices. Patients were sent to
hospital outpatient departments or safety-net facilities. When we
returned to these practices in 2005, we found they were sending more
patients to the HOPD. (Hospitals in these markets also reported they
were treating more patients with supplemental insurance who required
expensive new drugs.)
When patients are sent to the hospital for chemotherapy, the
physician continues to manage their care. Physicians still provide
evaluation and management visits, some lab work, and other services in
the office setting. The patient only receives the chemotherapy infusion
in the hospital. Although quality of care may be equivalent in
hospitals and physician offices, beneficiaries face higher copayments
in HOPDs and treatment usually takes longer. For example, chemotherapy
drugs must be mixed in the hospital pharmacy, where pharmacists are
preparing medications for all the other hospital patients. The
chemotherapy patient will wait longer until the medication is prepared.
Only a few beneficiaries who participated in our focus groups had been
referred to the HOPD from physician offices. They emphasized the
duplication of tests and increased time commitments caused by the
switch. One individual complained about the higher copayments.
As the price of new single source cancer drugs continues to rise,
beneficiaries without supplemental insurance may have an increasingly
hard time paying their 20 percent coinsurance. Although most physician
practices have continued to treat all beneficiaries in their offices,
beneficiary inability to meet cost-sharing requirements creates a
financial liability for the practices. Many practices have begun to
counsel beneficiaries on their estimated out-of-pocket liabilities
before treatment begins. A few practices reported instances in which
beneficiaries refused treatment because they did not want to travel to
a hospital or leave her family with debts caused by her out-of-pocket
We cannot quantify the number of beneficiaries who need help paying
their coinsurance for chemotherapy. We have no source of data to
determine the number of Medicare beneficiaries without supplemental
insurance who are receiving chemotherapy services. Data on supplemental
insurance are not captured on Medicare claims. The oncology practices
we visited estimated between 5 and 20 percent of their Medicare
patients have no source of supplemental coverage. Estimates varied
depending on the demographic structure of the market and the
availability of Medicare Advantage and retiree health insurance. The
Commission (MedPAC 2005a) estimates that, in general, 9 percent of
beneficiaries have no source of supplemental coverage. Beneficiaries
without supplemental coverage are not the only individuals facing high
copayments. Some cancer patients who participated in beneficiary focus
groups were concerned that they might exceed lifetime caps on their
Many pharmaceutical companies offer patient assistance programs to
help patients with the cost of their medications. In 2003,
pharmaceutical companies provided patients with medications valued at
$3.3 million. However, this assistance is not readily available for
Medicare beneficiaries without supplemental insurance. Most of the
assistance goes to patients without any insurance. Less aid is
available for individuals needing help with copayments. Yet this cost
may be beyond the means of many beneficiaries. For example, one new
cancer drug costs Medicare an average of $12,000 every two weeks.
Beneficiaries face copayments of $2,400 monthly for this medication.
They continue taking the medication until the patient's condition
The Commission is concerned about the burden of cost sharing for
beneficiaries with cancer and other catastrophic conditions. We intend
to explore the general issue of unlimited beneficiary out-of-pocket
liability, which can affect cancer patients and patients with other
illnesses, in future work.
Chemotherapy and quality of care
The Congress directed the Commission to report whether quality of
care was affected by Medicare payment changes for chemotherapy
services. Based on our interviews and site visits, we found no
indication that quality of care has been affected by the payment
changes. However, few consensus quality indicators for chemotherapy-
related services exist and data to evaluate indicators that do exist
We discussed perceptions of differences in quality of care with
physicians and patients in the course of our site visits and focus
groups. Not surprisingly, clinicians we interviewed think the quality
of services they provide is quite high. We found that physicians'
evaluation of differences in quality across settings was subjective and
seemed to be dictated by where they practiced. Oncologists in single-
specialty practices felt they had more experience in educating patients
about their condition and were more likely to hire oncology-certified
nurses. They felt they provided more continuity of care and greater
convenience for patients. By contrast, physicians practicing in
hospital settings pointed to the availability of staff pharmacists to
mix drugs, maintaining that this resulted in higher quality and fewer
medical errors. They also pointed to greater use of safety guidelines
and standard treatment protocols as indicators of higher-quality care.
Beneficiaries who participated in our focus groups received
treatment in a variety of settings, including single-specialty oncology
offices, outpatient departments of community hospitals, outpatient
departments in university hospital cancer centers, and infusion centers
of integrated health plans. Almost without exception, beneficiaries
praised the quality of care they received. (The one exception was a
beneficiary dually eligible for Medicare and Medicaid who received
treatment in the HOPD of a safety-net institution.) None experienced
changes in the quality of care received in the past year. Two focus
group participants had switched to HOPDs for chemotherapy
administration from physician offices in 2005. Neither felt quality of
care suffered, although both felt there was less coordination of care
and greater out-of-pocket expense in the hospital.
In general, further work is needed to determine quality
chemotherapy care. Current public and private initiatives to define and
measure quality of cancer care can provide the framework for a pay-for-
performance oncology quality initiative. However, there is one instance
where the Commission finds that CMS can take action now to monitor the
quality of care beneficiaries are receiving.
Erythroid growth factors (Erythropoeitin alpha and darbepoeitin
alpha) are used for the treatment of anemia following chemotherapy as
well as some other indications. Medicare expenditures for these
products account for the highest percentage of Medicare Part B drug
spending. Although the shift to ASP resulted in lower payment rates for
both products, volume and expenditures continued to increase in 2005.
At the same time, concerns have been raised about drug safety and
potential under- and overuse of these products. In 2004, the Food and
Drug Administration (FDA) responded to safety concerns about the use of
growth factors by issuing new prescribing information. Although some
local carriers have attempted to limit the use of erythroid growth
factor in accordance with FDA regulations and clinical guidelines,
carriers are hampered by their lack of access to all relevant clinical
data. In our January 2006 report, the Commission recommended that the
Secretary require providers to enter patients' hemoglobin level on all
claims for erythroid growth factors. This data should be used as part
of Medicare's pay-for-performance initiative.
Policymakers had long agreed that Medicare did not pay accurately
for Part B drugs or drug administration services and suggested
different alternatives. Although the Commission did not recommend any
particular new payment method, our analysis showed that several of the
proposed methods would improve the accuracy of the payment system.
Following passage of the MMA, Congress reduced payments for drugs and
increased payments for drug administration services. In 2005, Medicare
began using ASP to set payment rates for Part B drugs. This change
lowered the payment rate for most drugs and decreased Medicare spending
for Part B drugs. Payment for drug administration services increased.
Part B drugs are used to treat patients with very serious medical
conditions including cancer, hemophilia, and rheumatoid arthritis. The
Congress directed MedPAC to study the effect of the payment changes to
ensure that access and quality of care for individuals with these
illnesses were not harmed. We found that that, in general, beneficiary
access to chemotherapy services remained good. Physicians provided more
chemotherapy services to Medicare beneficiaries in 2005 than in 2004.
The ASP payment method has generally lowered beneficiary cost
sharing for Part B drugs. However, beneficiaries without supplemental
insurance may face high out-of-pocket spending, particularly if they
need new single source drugs. These drugs are expensive and Medicare
has no limit on the out-of-pocket costs that beneficiaries may face.
Some physicians are sending individuals without supplemental insurance
to hospital outpatient departments for chemotherapy infusions where
they face still higher copayments. The Commission is concerned about
the burden of cost-sharing faced by beneficiaries with cancer and other
catastrophic conditions and we intend to explore this issue in future
We found no evidence that the quality of care received by Medicare
beneficiaries has declined. However, we are concerned that the
continuing increase in use of erythroid growth factor should be
monitored to make sure that use falls within accepted clinical
guidelines. The Commission has recommended that the Secretary require
providers to enter patients' hemoglobin level on all claims for
erythroid growth factors. This data should be used as part of
Medicare's pay-for-performance initiative.
Overall we found that access to care and quality of chemotherapy
services were not harmed in 2005. However, we recognize that no payment
system is without flaws. Changes in both pricing and purchasing
patterns may affect the accuracy of drug payments over time. For this
reason, we have recommended that the Secretary continue to monitor
provider drug acquisition costs in both physician offices and dialysis
As directed by the Congress, MedPAC is currently studying the
effect of the Medicare payment changes on services provided by other
specialties including urologists, rheumatologists, and infectious
disease specialists. In this report, due January 1, 2007, we will
analyze if beneficiary access, quality of care, or physician practices
have been affected following an additional year of experience with the
new payment system.
Chairman JOHNSON OF CONNECTICUT. Mr. Steinwald.
STATEMENT OF BRUCE STEINWALD, DIRECTOR, HEALTH CARE, U.S.
GOVERNMENT ACCOUNTABILITY OFFICE
Mr. STEINWALD. Thank you, Mrs. Johnson, Mr. Stark and other
Members of the Subcommittee. I am pleased to be here with you
this afternoon, and I commend you for scheduling this hearing,
because given the fiscal crisis facing the Medicare Program, it
is essential that the payments be based on accurate information
and incentives for providers to operate as efficiently as
possible. I will skip over the part of my testimony that
relates to how we got to ASP because that has been covered.
My remarks this afternoon are based on work that we did in
response to several MMA requirements related to the study of
payment for separately billable part B drugs delivered in the
hospital outpatient setting. Cutting right to the bottom line,
we found that compared with alternative payment methods, ASP is
a practical basis for payment for the following reasons.
First, ASPs are based on actual transaction prices and are
a better proxy for provider acquisition costs than average
wholesale prices or provider charges included on claims for
payment, neither of which is based on real transactions.
Second, ASPs, which manufacturers update quarterly, offer
information that is relatively timely for rate setting. In
comparison, rates for other Medicare payment systems are based
on data that are not so current. Third, using manufacturers as
the data source for drug prices is preferable to collecting
such data from providers, because the manufacturers have data
systems in place to track prices, whereas providers generally
We learned from our survey of hospitals on how much they
paid for part B drugs that obtaining price data was very
burdensome on hospitals, and, by the way, on us as data
collectors as well, and we recommended against using such
surveys as a regular data source. So, for these reasons, we
concluded that ASP is a practical source of data from the
standpoint of collecting data for rate-setting purposes.
Practical does not imply perfect or even optimal, as has been
When CMS proposed to use ASP for hospital outpatient drugs
in 2006, we commented that ASP is what we called a ``black
box'' because of the lack of information on how manufacturers
calculate average drug prices. For example, the law
appropriately requires that average prices to be net of
rebates. Rebates are price concessions granted by manufacturers
sometime after the purchase and delivery of the drugs. We
learned from our hospital survey that it is very difficult to
deduct a rebate amount from an individual drug purchase because
rebates are often granted for a collection of drugs and other
products over a period of time.
While most of the hospitals we surveyed reported receiving
one or more rebate checks, they were unable to tell us how
rebates affected the individual drug prices. Some hospitals
even deposited their rebate checks in non-patient revenue
accounts along with gift shop and parking lot revenues because
their accounting systems were unable to accommodate those
payments elsewhere. Our experience with the hospitals we
surveyed made us wonder how manufacturers would account for
rebates when they reported average sales price to CMS, and we
were concerned to learn that CMS does not provide specific
guidance to manufacturers on how to account for rebates. Nor do
they have information to determine whether rebates are handled
consistently and appropriately across manufacturers and across
There are other reasons to want to peer into the ASP black
box. For example, CMS does not instruct manufacturers to
provide a breakdown of price and volume data by purchaser type;
that is, by physicians, hospitals and other health care
providers, and by wholesalers, which purchase drugs for resale
to health care providers. As a result, CMS cannot determine how
well the average price data represent actual acquisition costs
for different purchaser types. In particular, to the extent
that some of the sales are to wholesalers that subsequently
mark up manufacturers' prices in their sales to providers, the
ASP representation of provider acquisition cost is attenuated.
Finally, there is the plus factor, the 6 percent add-on to
ASP. I can't tell you whether the 6 percent is the right amount
or not, but our experience with hospital outpatient drug prices
may be instructive. Our survey of hospital acquisition costs
found that paying for such drugs at ASP plus 6 percent would
have been excessive in 2006. Although the law requires CMS to
pay hospitals their average acquisition costs, our survey found
that hospitals' payments for the drugs were somewhat below ASP
plus 6 percent. In its final rule, CMS did settle on ASP plus 6
percent, reasoning that part of the payment was for handling
costs as opposed to acquisition. Our conclusion from this
experience, and looking at part B drug payments more generally,
is that the empirical foundation for plus 6 percent or any
other percentage add-on is insufficient, and once again we
believe that a better understanding of the components of ASP
would be a worthwhile beginning to determine an appropriate
plus factor. Mrs. Johnson, I will end my remarks with that, and
I would be happy to answer any of your questions or those of
other Members of the Subcommittee.
Chairman JOHNSON OF CONNECTICUT. Thank you very much.
[The prepared statement of Mr. Steinwald follows:]
Statement of Bruce Steinwald, Director, Health Care, U.S. Government
Madam Chairman and Members of the Subcommittee:
I am pleased to be here as you discuss Medicare's method of paying
for outpatient drugs covered under the program's Part B, the part of
Medicare that covers a broad range of medical services, including
physician, laboratory, and hospital outpatient department (HOPD)
services and durable medical equipment (DME). Part B-covered drugs are
typically administered by a physician or other medical professional
rather than by patients themselves. In contrast, drugs covered under
the new prescription drug benefit, known as Part D, are generally self-
administered by patients.\1\ In 2005, Medicare paid more than $9
billion for Part B drugs furnished in conjunction with physician
services, HOPD services, dialysis services, and services performed
using DME, such as nebulizers.\2\\,\\3\
\1\ Medicare Part A covers inpatient hospital services; Medicare
Part C, known as Medicare Advantage, covers beneficiaries enrolled in
managed care plans.
\2\ In this testimony, we will refer to physicians, hospital
outpatient services, dialysis services, and durable medical equipment
suppliers collectively as providers.
\3\ A nebulizer is a device driven by a compressed air machine. It
allows the patient to inhale medicine in the form of a mist.
Until 2005, Medicare's method of paying physicians for Part B drugs
was based on the drug's average wholesale price (AWP), which, despite
its name, was neither an average nor what wholesalers charged.\4\ It
was a price that manufacturers derived using their own criteria; there
were no requirements or conventions that AWP reflect the price of an
actual sale of drugs by a manufacturer.\5\ An analysis we conducted in
2001 on Part B drug prices found that Medicare's AWP-based payments
often far exceeded market prices that were widely available to health
\4\ Until 2004, Medicare paid physicians 95 percent of AWP.
Legislation changed Medicare's payment to 85 percent of AWP in 2004.
\5\ Manufacturers reported AWPs to organizations that published
them in drug price compendia, and the Medicare claims administration
contractors that pay claims for Part B drugs based physicians' payments
on the published AWPs.
\6\ GAO, Medicare: Payments for Covered Outpatient Drugs Exceed
Providers' Costs, GAO-01-1118 (Washington, D.C.: Sept. 21, 2001).
The Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (MMA) mandated that, beginning in 2005, payments for physician-
administered drugs be based on the drug's average sales price (ASP)--
that is, an average, calculated from price and volume data reported by
drug manufacturers, of sales to all U.S. purchasers.\7\ The law
directed that ASPs be net of rebates and other price concessions and
that 2005 payments to physicians for these drugs be set at 106 percent
\7\ Certain prices were excluded, including prices paid to federal
purchasers and prices for drugs furnished under the Part D program.
\8\ The term rebates refers to price concessions given to
purchasers by manufacturers subsequent to receipt of the product.
The MMA took a different approach to setting rates for a subset of
Medicare Part B drugs delivered in the HOPD setting. Prior to the MMA,
Medicare paid HOPDs for Part B drugs based on hospitals' 1996 median
costs for these drugs. In response to concerns that payments would not
reflect the cost of newly introduced pharmaceutical products--such as
those used to treat cancer or rare blood disorders--1999 legislation
authorized augmented payments for these drugs on a temporary basis.\9\
Subsequently, the MMA defined a new payment category for these drugs
called specified covered outpatient drugs (SCOD). The MMA required the
Centers for Medicare & Medicaid Services (CMS) in the Department of
Health and Human Services (HHS) to set rates for this subset of Part B
drugs. Specifically, it directed CMS to set 2006 payment rates for SCOD
products equal to hospitals' average acquisition costs--the cost to
hospitals of acquiring a product, net of rebates. Subsequently, CMS
selected ASP as the basis to pay for SCODs provided at HOPDs.
\9\ See the Medicare, Medicaid, and SCHIP Balanced Budget
Refinement Act of 1999, Pub. L. No. 106-113, app. F, 201 (b), 113
Stat. 1501A-321, 1501A-337--1501A-339.
In several related requirements, the MMA directed us to provide
information on SCOD costs and CMS's proposed rates. Among them was a
requirement to conduct a survey of a large sample of hospitals to
obtain data on their acquisition costs for SCODs and provide
information based on these data to the Secretary of Health and Human
Services for his consideration in setting 2006 Medicare payment
rates.\10\ We were also required to evaluate CMS's proposed rates for
SCODs, comment on their appropriateness in light of the survey we
conducted, and advise on future data collection efforts by CMS based on
our survey experience.\11\ We issued reports in 2005 and 2006 in
response to these requirements, and my remarks about ASP are based on
that work. Specifically, my remarks today will focus on (1) ASP as a
practical and timely data source for use in setting Medicare Part B
drug payment rates and (2) components of ASP that are currently unknown
and implications for Medicare rate-setting. Our work was conducted in
accordance with generally accepted government auditing standards.
\10\ We provided information from this survey in two reports--one
on drugs and another on radiopharmaceuticals. See GAO, Medicare: Drug
Purchase Prices for CMS Consideration in Hospital Outpatient Rate
Setting, GAO-05-581R (Washington, D.C.: June 30, 2005), and GAO,
Medicare: Radiopharmaceutical Purchase Prices for CMS Consideration in
Hospital Outpatient Rate Setting, GAO-05-733R (Washington, D.C.: July
14, 2005). The Secretary of HHS considered the price data we provided
but elected not to use these data as the basis for 2006 rates.
\11\ We provided our comments on the proposed rates in 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). We provided information on our data
collection experience in GAO, Medicare Hospital Pharmaceuticals: Survey
Shows Price Variation and Highlights Data Collection Lessons and
Outpatient Rate-Setting Challenges for CMS, GAO-06-372 (Washington,
D.C.: Apr. 28, 2006).
In summary, using an ASP-based method to set payment rates for Part
B drugs is a practical approach compared with methods based on
alternative data sources, for several reasons. First, ASP is based on
actual transactions and is a better proxy for health care providers'
acquisition costs than AWP or health care providers' charges included
on claims for payment, neither of which is based on transaction data.
Second, ASPs, which manufacturers update quarterly, offer information
that is relatively timely for rate-setting purposes. In comparison,
rates for other Medicare payment systems are based on data that may be
at least 2 years old. Finally, using manufacturers as the data source
for prices is preferable to collecting such data from health care
providers, as the manufacturers have data systems in place to track
prices, whereas health care providers generally do not have systems
designed for that purpose.
Despite these advantages, CMS lacks certain information about the
composition of ASP that prompted us, in our report commenting on CMS's
proposed 2006 SCOD rates, to call ASP ``a black box.'' \12\
Significantly, CMS lacks sufficient information on how manufacturers
allocate rebates to individual drugs sold in combination with other
drugs or other products; this is important, as CMS does not have the
detail it needs to validate the reasonableness of the data underlying
the reported prices. In addition, CMS does not instruct manufacturers
to provide a breakdown of price and volume data by purchaser type--that
is, by physicians, hospitals, other health care providers, and
wholesalers, which purchase drugs for resale to health care providers.
As a result, CMS cannot determine how well average price data represent
acquisition costs for different purchaser types. In particular, to the
extent that some of the sales are to wholesalers that may subsequently
mark up the manufacturer's price in their sales to health care
providers, the ASP's representation of providers' acquisition costs is
weakened. Additionally, a sufficient empirical foundation does not
exist for setting the payment rate for Medicare Part B drugs at 6
percent above ASP, further complicating efforts to determine the
appropriateness of the rate. Given these information gaps, CMS is not
well-positioned to validate the accuracy or appropriateness of its ASP-
based payment rates.
CMS calculates payment rates for each Part B drug with information
on price data that manufacturers report quarterly to the agency. In
reporting their price data to CMS, manufacturers are required to
account for price concessions, such as discounts and rebates, which can
affect the amount health care providers actually pay for a drug.
ASP Is a Price Measure Established in Law and Calculated with
The MMA defined ASP as the average sales price for all U.S.
purchasers of a drug, net of volume, prompt pay, and cash discounts;
charge-backs and rebates. Certain prices, including prices paid by
federal purchasers, are excluded, as are prices for drugs furnished
under Medicare Part D. CMS instructs pharmaceutical manufacturers to
report data to CMS--within 30 days after the end of each quarter--on
the average sale price for each Part B drug sold by the manufacturer.
For drugs sold at different strengths and package sizes, manufacturers
are required to report price and volume data for each product, after
accounting for price concessions. CMS then aggregates the manufacturer-
reported ASPs to calculate a national ASP for each drug category.\13\
\13\ Manufacturers' reported price data are based on the Food and
Drug Administration's (FDA) system of National Drug Codes, while the
ASP that CMS calculates for each drug is based on the agency's
Healthcare Common Procedure Coding System, which uses categories that
are broader than the FDA's coding system.
Varying Payment Arrangements Affect the Price Purchasers Pay at the
Time of Sale
Common drug purchasing arrangements can substantially affect the
amount health care providers actually pay for a drug. Physicians and
hospitals may belong to group purchasing organizations (GPO) that
negotiate prices with wholesalers or manufacturers on behalf of GPO
members. GPOs may negotiate different prices for different purchasers,
such as physicians, suppliers of DME, or hospitals. In addition, health
care providers can purchase covered outpatient drugs from general or
specialty pharmaceutical wholesalers or can have direct purchase
agreements with manufacturers. In these arrangements, providers may
benefit from discounts, rebates, and charge-backs that reduce the
actual costs providers incur. Discounts are applied at the time of
purchase, while rebates are paid by manufacturers some time after the
purchase. Rebates may be based on the number of several different
products purchased over an extended period of time. Under a charge-back
arrangement, the provider negotiates a price with the manufacturer that
is lower than the price the wholesaler normally charges for the
product, and the provider pays the wholesaler the negotiated price. The
manufacturer then pays the wholesaler the difference between the
wholesale price and the price negotiated between the manufacturer and
ASP Is a Practical Payment Approach, Given the Limitations of Other
Data Sources Available for Rate-Setting
Using an ASP-based method to set prices for Medicare Part B drugs
is a practical approach compared with alternative data sources for
several reasons. First, unlike AWP, ASP is based on actual
transactions, making it a useful proxy for health care providers'
acquisition costs. Whereas AWPs were list prices developed by
manufacturers and not required to be related to market prices that
health care providers paid for products, ASPs are based on actual sales
to purchasers. For similar reasons, payments based on ASPs are
preferable to those based on providers' charges, as charges are made up
of costs and mark-ups, and mark-ups vary widely across providers,
making estimates of the average costs of drugs across all providers
wide-ranging and insufficiently precise. In addition, basing payments
on charges does not offer any incentives for health care providers to
minimize their acquisition costs.
Second, ASPs offer relatively timely information for rate-setting
purposes. Manufacturers have 30 days following the completion of each
quarter to report new price data to CMS. Before the end of the quarter
in which manufacturers report prices, CMS posts the updated Part B drug
payment rates, to take effect the first day of the next quarter. Thus,
the rates set are based on data from manufacturers that are, on
average, about 6 months old. In comparison, rates for other Medicare
payment systems are based on data that may be at least 2 years old.
Third, acquiring price data from manufacturers is preferable to
surveying health care providers, as the manufacturers have data systems
in place that track prices, whereas the latter generally do not have
systems designed for that purpose. In our survey of 1,157 hospitals, we
found that providing data on drug acquisition costs made substantial
demands on hospitals' information systems and staff. In some cases,
hospitals had to collect the data manually, provide us with copies of
paper invoices, or develop new data processing to retrieve the detailed
price data needed from their automated information systems.\14\
Hospital officials told us that, to submit the required price data,
they had to divert staff from their normal duties, thereby incurring
additional staff and contractor costs. Officials told us their data
collection difficulties were particularly pronounced regarding
information on manufacturers' rebates, which affect a drug's net
acquisition cost.\15\ In addition, we incurred considerable costs as
data collectors, signaling the difficulties that CMS would face should
it implement similar surveys of hospitals in the future.
\14\ The burden was more taxing for some hospitals than for others.
Many hospitals were able to rely on price data downloaded from their
drug wholesalers' information systems.
\15\ Typically, hospitals did not systematically track all
manufacturers' rebates on drug purchases, although nearly 60 percent of
hospitals reported receiving one or more rebates.
CMS Lacks Information on ASP Necessary to Monitor Payment Rate Accuracy
Despite its practicality as a data source, ASP remains a ``black
box.'' That is, CMS lacks detailed information about the components of
manufacturers' reported price data--namely, methods manufacturers use
to allocate rebates to individual drugs and the sales prices paid by
type of purchaser. Furthermore, for all but SCODs provided in the HOPD
setting, no empirical support exists for setting rates at 6 percent
above ASP, and questions remain about setting SCOD payment rates at
ASP+6 percent. These information gaps make it difficult to ensure that
manufacturers' reported price data are accurate and that Medicare's ASP
rates developed from this information are appropriate.
Significantly, CMS has little information about the method a
manufacturer uses to allocate rebates when calculating an ASP for a
drug sold with other products. Unlike discounts, which are deducted at
the point of purchase, rebates are price concessions given by
manufacturers subsequent to the purchaser's receipt of the product. In
our survey of hospitals' purchase prices for SCODs, we found that
hospitals received rebate payments following the receipt of some of
their drug purchases but often could not determine rebate amounts.
Calculating a rebate amount is complicated by the fact that, in some
cases, rebates are based on a purchaser's volume of a set, or bundle,
of products defined by the manufacturer. This bundle may include more
than one drug or a mixture of drugs and other products, such as
bandages and surgical gloves. Given the variation in manufacturers'
purchasing and rebate arrangements, the allocation of rebates for a
product is not likely to be the same across all manufacturers. CMS does
not specifically instruct manufacturers to provide information on their
rebate allocation methods when they report ASPs. As a result, CMS lacks
the detail it needs to validate the reasonableness of the data
underlying the reported prices.
In addition, CMS does not require manufacturers to report details
on price data by purchaser type. Because a manufacturer's ASP is a
composite figure representing prices paid by various purchasers,
including both health care providers and wholesalers, CMS cannot
distinguish prices paid by purchaser type--for example, hospitals
compared with other institutional providers, physicians, and
wholesalers. In particular, to the extent that some of the sales are to
wholesalers that may subsequently mark up the manufacturer's price in
their sales to health care providers, the ASP's representation of
providers' acquisition costs is weakened. Thus, distinguishing prices
by purchaser type is important, as a central tenet of Medicare payment
policy is to pay enough to ensure beneficiary access to services while
paying pay no more than the cost of providing a service incurred by an
efficient provider. In our 2005 report on Medicare's proposed 2006 SCOD
payment rates, we recommended that CMS collect information on price
data by purchaser type to validate the reasonableness of ASP as a
measure of hospital acquisition costs.\16\
Better information on manufacturers' reported prices--for example,
the extent to which a provider type's acquisition costs vary from the
CMS-calculated ASP--would help CMS set rates as accurately as possible.
For most types of providers of Medicare Part B drugs--physicians,
dialysis facilities, and DME suppliers--no empirical support exists for
setting rates at 6 percent above ASP. In the case of HOPDs, a rationale
exists based on an independent data source--our survey of hospital
prices--but the process of developing rates for SCODs was not simple.
In commenting on CMS's proposed 2006 rates to pay for SCODs, we raised
questions about CMS's rationale for proposing rates that were set at 6
percent above ASP.\17\ CMS stated in its notice of proposed rulemaking
that purchase prices reported in our survey for the top 53 hospital
outpatient drugs, ranked by expenditures,\18\ equaled ASP+3 percent on
average, and these purchase prices did not account for rebates that
would have lowered the product's actual cost to the hospital.\19\ We
noted that, logically, for payment rates to equal acquisition costs,
CMS would need to set rates lower than ASP+3 percent, taking our survey
data into account. In effect, ASP+3 percent was the upper bound of
acquisition costs. Consistent with our reasoning, CMS stated in its
notice of proposed rulemaking that ``Inclusion of . . . rebates and
price concessions in the GAO data would decrease the GAO prices
relative to the ASP prices, suggesting that ASP+6 percent may be an
overestimate of hospitals' average acquisition costs.'' In its final
rule establishing SCOD payment rates, CMS determined that our survey's
purchase prices equaled ASP+4 percent, on average, based on an analysis
of data more recent than CMS had first used to determine the value of
our purchase prices. CMS set the rate in the final rule at ASP+6
percent, stating that this rate covered both acquisition costs and
handling costs.\20\ We have not evaluated the reasonableness of the
payment rate established in the final rule.
\18\ These drugs accounted for 95 percent of Medicare spending on
all SCODs in the first 9 months of 2004.
\19\ The purchase prices hospitals reported to us took account of
discounts but not rebates.
\20\ Handling costs include providers' expenses associated with
storing, preparing, and disposing of drugs.
Lacking detail on the components of ASP, CMS is not well-positioned
to confirm ASP's accuracy. In addition, CMS has no procedures to
validate the data it obtains from manufacturers by an independent
source. In our 2006 report on lessons learned from our hospital
survey,\21\ we noted several options available to CMS to confirm the
appropriateness of its rates as approximating health care providers'
drug acquisition costs. Specifically, we noted that CMS could, on an
occasional basis, conduct a survey of providers, similar to ours but
streamlined in design; audit manufacturers' price submissions; or
examine proprietary data the agency considers reliable for validation
purposes. HHS agreed to consider our recommendation, stating that it
would continue to analyze the best approach for setting payment rates
Because ASP is based on actual transaction data, is relatively
timely, and is administratively efficient for CMS and health care
providers, we affirm the practicality of the ASP-based method for
setting Part B drug payment rates. However, we remain concerned that
CMS does not have sufficient information about ASP to ensure the
accuracy and appropriateness of the rates. To verify the accuracy of
price data that manufacturers submit to the agency, details are
needed--such as how manufacturers account for rebates and other price
concessions and how they identify the purchase prices of products
acquired through wholesalers. Equally important is the ability to
evaluate the appropriateness of Medicare's ASP-based rate for all
providers of Part B drugs over time. As we recommended in our April
2006 report, CMS should, on an occasional basis, validate ASP against
an independent source of price data to ensure the appropriateness of
Madam Chairman, this concludes my prepared statement. I will be
happy to answer any questions you or the other Subcommittee Members may
Chairman JOHNSON OF CONNECTICUT. Mr. Steinwald, I
appreciate your comments in regard to the black box of ASP. I
do think the ASP system is a better system than the AWP system,
but I am concerned about some of the weaknesses that are
inherent to it, at least the way we interpret it now.
What I understand you saying is that we ought to know, at
least somebody ought to know, what purchasers do to get that
automatic 2 percent cut in volume purchasing and what payers
don't. It may be that one of the reasons we are hearing such
varied comments and the adequacy of this system is that small
practices have less access to the volume discount that big
purchasers are able to negotiate. Do you think that may be a
Mr. STEINWALD. Yes, ma'am. We don't know at present whether
those average prices are wide-ranging across different
purchasers or very tightly distributed. In our survey of
hospitals, though, we did find that different hospitals were
paying different amounts for the same drugs. Teaching hospitals
tend to pay less because they are large purchasers, and the
manufacturers like to expose their products to doctors in
training in the hope of building some brand loyalty, and rural
hospitals tend to pay more because they tend to be more
isolated and are small purchasers. So, we have that information
from our survey, but we don't know, as far as I am concerned,
anything about the variability in prices paid across the
different kinds of providers whose prices are averaged in the
Chairman JOHNSON OF CONNECTICUT. It is an interesting
thought that you are finding small hospitals pay more, big
hospitals pay less. If the same is true for small practices
versus large practices, we ought to at least know it.
Mr. STEINWALD. Yes, ma'am.
Chairman JOHNSON OF CONNECTICUT. Dr. Miller, in the work
that MedPAC has done on this issue, you concluded in one of
your reports that pharmacy handling costs were about 25
percent, 28 percent, as I recall.
Mr. MILLER. I don't recall the exact percent. What I do
recall concluding is that we thought there was a substantial
cost there because of the way hospitals had chosen to do their
accounting and charging practices. It was hard to tease out of
the data precisely what those costs were, and we made a
recommendation that we move toward a fee schedule that attaches
a handling fee to how complex it is to administer a drug, an
oral drug obviously a lot less than a radiopharmacy drug.
Chairman JOHNSON OF CONNECTICUT. Did you look at that issue
in community practices?
Mr. MILLER. In community practices? I am sorry, the study
was about hospital outpatient.
Chairman JOHNSON OF CONNECTICUT. Because that same issue is
there in community practices where they have to handle the
drugs where they have to buy them, store them, so on and so
forth. The U.S. Department of Labor Occupational Safety and
Health Organization (OSHA) required a $25,000 investment last
year because they wanted a different kind of hood, yet that
isn't taken into account in the coding. We worked hard during
the coding process to get that taken into account, but it
explicitly wasn't. May that have some effect on whether or not
small practices are doing well under this system?
Mr. MILLER. It may have an effect. I know that several
steps were taken to change the rules and the coding that
allowed physicians in their practices to more comprehensively
bill for the administration of services; for example, when
multiple chemotherapy agents are introduced into the patient,
the ability to bill separately for each of those infusions. The
only thing I can speak to directly is in our work we did not
find that there was a loss of access in a physician's office.
We were finding the administration of those drugs were
increasing even after the implementation of the policy.
Chairman JOHNSON OF CONNECTICUT. You do find a difference
in access for those who had no insurance?
Mr. MILLER. Absolutely. I tried to be very on point on
that. If you don't have supplemental insurance, a Medigap
policy or employer wraparound, in some communities those
patients were being sent to the hospital outpatient.
Chairman JOHNSON OF CONNECTICUT. It is also very important
to note for the record that in some communities there is no
alternative. You can't send patients to the hospital. There
isn't one nearby. So, the fact that patients who don't have
coinsurance and can't afford the coinsurance get moved to
settings where it is less of a problem, that is a real thing
that is happening, and it is a real problem that is developing
in communities where there is no other place to refer those
patients. Wouldn't you guess that is a growing problem in those
Mr. MILLER. In those instances if we are talking about
rural areas, patients will have to travel.
Chairman JOHNSON OF CONNECTICUT. Mr. Kuhn, in discussing
the coding situation, you know, originally we said ASP would be
this and that. We would adjust the administration payments to
oncologists to take into account the legitimate cost of
delivering the drug, which had, before the reform, been paid
through the drug price itself. We were very careful instructing
that coding process because I personally had arranged for
whatever costs came out of it to be allowed and not to be held
to the budget-neutral standard, because we were saving the
money in the drug pricing, and we wanted it to go into coding.
It was very discouraging to me that we allow radiologists,
radiology oncologists, a management fee, and we don't allow
radiology--I mean, chemotherapy oncologists a management fee,
but we lost that. We also lost any recognition of these
pharmacy costs. We did get--but we did get some adjustments
through the coding system, but they were put into temporary D
codes. Now, several times I have sent over to your office and
personally handed to Dr. McClellan analyses that have been done
in the last few months of what has happened to those G codes as
they got merged the next year into C codes, and some of them,
while they were supposed to get increases, actually then began
to get decreases. So, knowing how hard it is to look for any--
at any one thing, I had them accommodate it, group things by
I would think we all really do have to take seriously that
the combined codes that you would--that you would bill to treat
breast cancer or colorectal cancer or lung cancer, that the
group of codes--and, for example, colorectal cancer has
declined from 2004 to 2006, very significantly down 36 percent.
That reflects--I mean, that really is concerning to me. If you
go through all of the chart that you will see in every area and
then anecdotally from individuals' practices, you see some of
these same things affirmed. So, when you begin to hear then
that since January 1, 2006 oncology offices are closing
satellite offices, that is another aspect. If you can move
people to the hospital, that is an aspect of strain on the
system. Closing satellite offices is something that is of
concern to me, because in rural areas that has made access to
cancer care--very great in Medicare, greater in our country
than in any other country--and as you close those satellite
offices, you do contract access. Then depending on what kinds
of cancer you treat--and so therefore, whether you are using
drugs on which there is a loss or drugs which there is a
profit, we are hearing more and more about cancer practices
that are reducing their--the number of Medicare patients they
can afford to take and so on. That anecdotal evidence, it is
very strong now.
I am very concerned that my personal office has not been
contacted about how you explain this kind of thing and how you
explain the clear evidence. When I say clear evidence, you
know, I am not talking the studies and the general stuff that
we do from Washington. I am talking decoders. People who do
this for a living, and who struggle with this across the
country, and who, when they try to code for the same treatment,
are coming out with a lower payment. Now, we expected some
lowering from the first year because we had that demonstration
project that plugged $300 million into the system, but I
wouldn't have expected to lose it all. I wouldn't have expected
to lose it all plus the transition payment. I wouldn't have
expected to actually go from G codes to a lower code payment.
That is what we seem to be seeing.
I think--I hope that you and your staff will look carefully
at the testimony and Exhibit A under the Code testimony because
we have got to get this right. If we don't get the
administrative payments right--and I appreciate all of your
big-sounding percentages, but remember, that is a percentage
increase from an administrative payment that was never intended
to cover the costs of 6 hours of monitoring--of delivering a
highly toxic substance into someone's body. So, we don't know
whether it is adequate just because it sounds big. If we don't
get this right, we will lose the access to cancer care that we
have developed to a greater extent than any other Nation, and
with it we will lose the ability to do clinical trials and
research that has kept us at the cutting edge of cancer care.
This isn't just about big money fleeing someplace. This is
about little people having access to care, and oncologists who
have been creative enough and willing to put themselves out to
have satellite offices to reach elderly out in rural areas
being able to continue to do.
I am not pleased that I have never had--this has been
months, you know. Never had anyone come and sit down and
explain to me why this isn't logical, when this is what people
who are living, are saying they are living. I think when you
look back at MedPAC's analysis of its true hospital delivery of
chemotherapy, they saw big pharmacy costs, and these individual
practices are handling those pharmacy costs, struggling under
nonpayment of copayments by those who don't have coverage and
so on. We don't have time to go into all of the problems here,
but I thank Mr. Steinwald for his testimony because that may
begin, if we begin to look--if you begin to look at the
reported prices in terms of volume buyers and non-volume
buyers, maybe we can find out what the problems are. If we look
honestly at pharmacy management, we might be able to look at--
we might be able to find that aspect of the problem.
I am going to turn now to Mr. Stark, but I did want to get
clearly on the record that there are issues being raised by
practitioners who are honest, hard-working folk out there that
we are unable to answer from our general studies, but which
some of the work that is being done does suggest that there are
problems in the system that could be lethal to small
practitioners, and they are crucial to access to care for our
seniors. Mr. Stark.
Mr. STARK. Thank you, Madam Chair. Dr. Miller, I thought
that in your testimony you indicated that while most drugs
could be purchased by physician offices regardless of size at
or below the reimbursement rate, there may be some that cannot.
Now, it also sounds like that may be some single-source, brand-
name drugs, but maybe I am reading something into your
testimony that doesn't exist. Could you--perhaps you could do
this later in letter. Could you codify as best you can how many
of these drugs fall below the reimbursement rate and whether
that is a disproportionate share of the demand of utilization?
I think there is--that your answer may determine how radical a
change we need.
I wanted to ask also at the same time that whether you or
any of the others know how the prices that we pay in Medicare
for these drugs compare with the Federal fee schedule. Does the
Veterans Affairs (VA) get them for half what we are paying,
roughly? Does anybody know?
Mr. KUHN. I don't think we have ever done a cross-walk on
that so I couldn't answer that question.
Mr. STARK. You want to make a guess?
Mr. KUHN. I wouldn't even hazard a guess.
Mr. STARK. Anybody know? Okay. That would be interesting.
We seem to--the VA seems to pay half of what everybody else in
the world pays. I would presume they are also getting the same
break on these. I won't tell you where that leads me to go.
What about the small practitioners who may not be able to get
Mr. MILLER. So, I think that the question was along the
lines of can you quantify, be a little bit more precise, about
this statement of who can buy and who can't buy. You know,
first thing just by way of caveat to keep in mind here is, you
know, we haven't done a national study. We went out and visited
some seven-some-odd communities, and this is what we are
bringing back. So, I can't truly quantify it. The types of
examples that we found out there were things like this. Oddly
enough, you know, your instinct would take you to a single-
source drug, but sometimes it was old generics because the fee
of purchasing it from a wholesaler exceeded the price of the
drug. So, you know, you found anomalous situations like that.
You also find situations where a drug may be extremely
expensive, and now you might be over here in the sole-source
situation, and let us say a provider wants to buy it, but wants
to get the prompt pay discount. That may literally create cash
flow issues, and so they may choose to not purchase the drug
under that circumstance. Those were the kinds of things when we
were sitting around with the oncology offices and talking to
the nurses and so forth and the managers, the types of things
that arose there, but I don't have a quantification of this.
Mr. STARK. Could I just follow on and talk about the other
side of this equation? The adequacy of the rates for physician
administration. Your testimony, Mr. Kuhn, indicates that
reimbursement has gone up considerably since the drug payment
changes. I assume that still holds even after they lose the 130
bucks per patient that they got for the so-called
demonstration. I don't know what it demonstrated except that
they were happy to take the 103 bucks per visit.
Do--can you comment, and I hope you can--now, what do you
need to be able to recommend to us, because it is basically
MedPAC that recommends. OIG, they would rather have their
tongues fall out than make a recommendation. They might tell us
what exists, but they are very careful about not recommending
and CMS is 50-50. Dr. Miller, we depend on to bring us the
technical expertise of his panel. Do you have enough
information to tell us about the adequacy of the rates for
physicians? If not, what do you need to get that, and can we
look forward to it?
Mr. MILLER. I think there is probably a couple of things,
and I am sorry that this is coming so much to me, because I
can't give you exactly an answer on this. I mean, one caveat,
again, is that the demonstration was still in play when we were
looking at things, so giving you a definitive answer is hard. I
think one key thing that you need to keep--that we all need to
keep track of, and we can keep track of this as well, is
whether the access to the services, are you seeing it. One
place you can look is to continue to look at the claims data to
see whether the services are being provided in the physician's
office. We found that that continued to increase. They
continued to buy the most expensive and the latest drugs, and
that it seems to be, at least so far, adequate payment.
I think those trends need to continue to be tracked,
because if that turns around, you will start to see it in the
data. I think also--I mean, ideally what you want here is to
know the cost of what the practice is incurring and how
carefully that is tracking, you know, both the administration
of the drug. Frankly, that data doesn't exist in the Medicare
system that I am aware of--the ability to look at the
physician's specific cost for the administration of the drugs
and compare that to Medicare's payment.
Mr. STARK. Would it help if the physicians submitted it?
They are the ones that are asking for more money. I think it
would be incumbent to give the data you need.
Mr. MILLER. I think the issue there is defining the data
that you want and the Medicare Program wants, and then the
burden that it would produce in order to generate that data,
and then, of course, the lag in collecting it before it could
be analyzed. Sort of the usual problems.
Mr. STARK. Are you going to try that?
Mr. MILLER. What we are doing right now is we have another
report due to you in January, I believe on January 1st of 2007,
in which we are going to be looking at other specialties as
well to ask the same questions that we asked oncology. We will
be taking another look, looking at the flow of data to have
some more information on where the major access problems have
appeared. We have not specifically contemplated the notion of
collecting cost data from physicians.
Mr. STARK. My time is up. I will come back.
Chairman JOHNSON OF CONNECTICUT. Mr. McCrery.
Mr. MCCRERY. Mr. Kuhn, you mentioned that HHS is
undertaking an independent study of the IVIG issue. Is that
different from the OIG's office study that they are doing?
Mr. KUHN. That is correct, Mr. McCrery.
Mr. MCCRERY. Who is doing that?
Mr. KUHN. The Assistant Secretary for Planning Evaluation,
also known as ASPE, is taking that on. We are going to look at
three principal activities here when they go forward in this.
One, they want to do a supply analysis, really kind of
understand what the supply looks like. Are there indeed ample
product in the marketplace? Are there shortages? Because we
have had some contractions in this industry in the past. They
also want to do a demand analysys and understand that much
better. Including that, they want to look at our reimbursement
levels and the way we calculate reimbursement in this area.
They want to look at product differentiation, and they want to
look at access issues thoughtfully. Finally, they want to
conduct a serious of public meetings as well to make sure that
the public understands and participates fully in this process,
with the target, as I understand right, now to report out
sometime this fall.
Mr. MCCRERY. This fall?
Mr. KUHN. That is the current target.
Mr. MCCRERY. Now, Mr. Vito, the OIG report, your testimony,
you say on IVIG it should be out soon. Can you give me a little
sharper definition of soon?
Mr. VITO. Yes. This Committee, along with the Commerce
Committee, asked us to look at IVIG for access and pricing. We
delivered the first phase to this Committee and the Commerce
Committee in June of this year. We are in the second phase,
which is looking at the Government Pension Offsets (GPOs) and
the distributors to find out what they are paying for the
product. We have completed our data collection. We are in the
analysis and report writing section of our work now. We hope to
have that to you within the next month or two. As far as
getting the information from the physicians, we have surveyed
the physicians. We are requesting that they provide the
information to us. We have been working hard to get a good
response rate and have gone back on at least a number of
occasions to get the information from the physicians. So, that
is a little bit longer out, but we do hope to have the next
phase to you shortly.
Mr. MCCRERY. I appreciate that. I do appreciate your
getting the first phase of that report to us on the
manufacturers. We don't have any manufacturers here today,
Madam Chairman. That is unfortunate, I wish we could have had
some manufacturers here. Before I get to that, Mr. Kuhn, you
said in your testimony that CMS has taken steps to try to
assure that there is supply in the market and that patients
have access, and that providers can get adequate reimbursement
for providing and administrating this life-saving drug. Just so
everybody here knows, if a severe immunodeficient patient does
not get this drug, he will die. That is how important this is.
It is not a matter of it is better than some other drug or
makes his quality of life better. He will die if he does not
get this. So, this is a critical, critical question for all of
us to make sure we get it right.
You mentioned, Mr. Kuhn, that you have taken steps to try
to ensure that access. One of those steps will expire at the
end of this year. It is the add-on pre-administrative fee that
you call it. Are you waiting until the OIG report and your
independent study before you decide to extend that? Or have you
thought of some interim steps to take prior to getting the
results that you are looking for?
Mr. KUHN. We are currently evaluating the effectiveness of
that particular step, whether it really did help both
physicians as well as hospitals in terms of their search for
the product, because, again, there has been some reported
shortages. People have reported to us that they have had
difficulty finding the product. So, we wanted to enable them
even more with this step to help them out in that area.
We are doing evaluation whether it is appropriate to extend
it in some other form, make other recommendations possibly for
2007, how we want to go forward. I think our current analysis
that we are doing right now and the report by ASPE is going to
help us in making those decisions. The work that the IG is
doing is going to help us in that as well as our outreach with
the stakeholder community, because we do want to engage them
about that and have discussions about that. It is a work in
progress that hopefully we will have more information soon on
what kind of recommendations we want to make.
Mr. MCCRERY. Just very quickly. I know you understand this.
You understand the critical nature of this question. We just
can't abide patients not having access to this until we figure
out why. We have to make sure that they have access. So, I
appreciate the steps you have taken, Mr. Kuhn--CMS has taken so
far. I hope you will stay on top of it not at the end of the
year, but tomorrow, and make sure that we are doing all we can
to ensure patient access to this drug. I have got some other
questions later for Dr. Orange about the supply problem, but I
will talk about that then. Thank you, Madam Chairman.
Chairman JOHNSON OF CONNECTICUT. Mr. Johnson.
Mr. JOHNSON of Texas. Thank you, Madam Chairman. Mr. Vito,
I have a good friend who was diagnosed with an autoimmune
disease earlier this year, and 2 weeks ago she was give an
infusion of IVIG. Condition greatly improved, whereas before
she had weakness affecting eyesight, speech, swallowing and
others, she is now able to see clearly and speak at length
without slurring her words. You know, there are hundreds of
stories like that out there, and it is of critical importance
that miracle drugs like that remain available to those who
really don't have anywhere else to turn.
The OIG, as you know, has been tasked to evaluate the
current state of pricing and supply for IVIG. Based on
preliminary results from your study, do you believe the
administrative changes taken by CMS to increase the
reimbursement of IVIG have alleviated some of the concerns
expressed by patient advocacy groups and physicians?
Mr. VITO. Based on the work that we have done so far, we
cannot answer that question. As we get more data from the other
two sources, we might be in a better position to provide some
information to you.
Mr. JOHNSON of Texas. You don't have any ideas yourself?
Let me just ask you, in your opinion, what more can be done to
ensure that patients receive the treatment in the most cost-
effective setting, that is doc's office or the hospital? Do you
have a preference, or have you formed an opinion?
Mr. VITO. I work for the Office of Inspector General. We
were asked to do specific work for this Committee and the other
Committee, and we are focusing on that work. I do not have an
opinion on that. I could tell you that we are trying to get the
work done in the most expedient manner so that we will have
some information to help you make decisions on how to move
Mr. JOHNSON of Texas. You said that two or three times. In
other words you don't want to go on the record with your own
Mr. VITO. No, sir.
Mr. JOHNSON of Texas. Do any of you?
Mr. KUHN. Mr. Johnson, I would just say, Mr. McCrery
identified one of the actions that we have taken already in
terms of trying to help with this issue. There has been some
others that the agency has taken, and obviously we want to look
further to make sure we do right for these patients, because I
think your point about the patient and how this product--it is
a remarkable product that makes all the difference in the world
for these people in their lives, and we need to make sure that
there is uninterrupted access to them and to the clinicians for
getting this product.
In addition to the pre-administration fee, we have also
worked closely with, hard with the manufacturers to make sure
that they are reporting to us as accurately as they possibly
can on their ASP pricing. We want to make sure when we do the
quarterly updates, we are on the spot in terms of what the
pricing is so that there is no deviation whatsoever, to make
sure that works. Likewise, last year, at the request of the
stakeholder community, we began splitting the Codes out. Up
until then we had one code for this product. It comes in two
different forms, liquid and powder, and we split that apart in
order to help them differentiate and work in that area as well.
Also, we are working very hard with the Public Health Service
and the Food and Drug Administration (FDA). FDA is doing a lot
of good surveillance in terms of working with the manufacturers
dealing with supply issues to help them where there might be
regulatory issues. We have a pretty enterprise-wide action plan
within the agency to do this. I think the study is going to
help us understand if there are more things that we ought to be
doing to make sure that we get this product to the people that
Mr. JOHNSON of Texas. Thank you, sir. Appreciate your
comments. I yield back the balance of my time.
Mr. MCCRERY. Would you yield?
Mr. JOHNSON of Texas. I yield to you.
Mr. MCCRERY. Just in case you are looking for some other
tool, you already have one at your disposal, I think. Blood-
derived products you reimburse at 95 percent of AWP, which I
assume would be higher if you applied that to IVIG, which is a
plasma-based product you could describe as a blood-derived
product. I assume that would be a higher reimbursement than the
current reimbursement rate, wouldn't it?
Mr. KUHN. That is correct. If blood and blood products are
currently reimbursed at 95 percent of AWP. The issue with this
particular product, however, in the MMA Congress did designate
this product as not a blood and blood product separately from
that. So, in terms of our discretionary authority to make that
adjustment, we don't believe we have that authority.
Mr. MCCRERY. Madam Chairman, maybe that is something we
need to look at and give CMS the flexibility to make that
change. Thank you.
Chairman JOHNSON OF CONNECTICUT. Mr. Ramstad.
Mr. RAMSTAD. Thank you, Madam Chairman. Thank you also,
Madam Chairman, for highlighting the fact that one of the key
areas impacted by recent changes in the Part B drug
reimbursement certainly has been the practice of oncology. I
don't think it is hyperbole to state categorically that our
cancer care delivery system is facing a crisis. Now, I have
heard concerns expressed here today in the exchanges, heard
concerns from numerous cancer patients back home, from
countless oncologists and others that when you analyze this,
drug administration has dropped by over 20 percent in terms of
reimbursement just in the last 2 years. At the same time
reimbursement for acquiring the drugs has decreased by over 30
Then when you look at the recent findings of the study done
by PricewaterhouseCoopers, they estimate that cancer care
payments will be cut by almost $14 billion 2004 to 2013.
Congressional Budget Office (CBO) had estimated a $4.2 billion
reduction in payments over that period. We all know CMS,
Director Kuhn, has drastically reduced the demonstration
project that was supposed to make up for shortfalls. Why in the
world have there been no permanent solutions to maintain
critical Medicare funding for cancer care? Why not, for
example, add payment codes for treatment planning as has been
Mr. KUHN. Those are all good questions, Mr. Ramstad, and
here is where we are in the sequence, and I would like to walk
the Committee through these because----
Mr. RAMSTAD. I want to know why there hasn't been permanent
solutions for maintaining critical Medicare funding for cancer
care? That is the question that needs to be broached, needs to
be answered. Why specifically not add payment codes for
treatment planning? Please answer those two questions.
Mr. KUHN. Sure. From 2003 to 2006, administration codes are
up 117 percent across the board is where we are right now.
Those are permanent changes over those 3-year periods as we
move forward. Administrative utilization for cancer care from
2003 to 2004 is up 21 percent; from 2004 to 2005 it is up 31
percent. So, we are seeing real increases in this area as we go
forward. In terms of planning codes, when we went through this
process, and we did 2 successive years and both 2004 and 2005
in terms of making changes, and the 2004 changes we used the
actual data that oncology physicians gave us, their survey
data, in order to make the permanent changes in the Codes. In
2005, the changes we made were put to us by the current
procedural terminology (CPT) editorial Committee, which is run
by the American Medical Association (AMA). At that particular
Committee they did not recommend that there be any planning
code, that that function is already captured in the evaluation
and management (E&M) codes that are out there. We use used the
oncologist data, and then we used the regular order in terms of
the process that exists with existing Committees to drive these
codes forward, and the results are there: 117 percent increase.
Mr. RAMSTAD. Well, I am looking at an average per-treatment
basis, why has Medicare reimbursement decreased by over 20
percent the past 2 years?
Mr. KUHN. The data that I have and that I see from 2003 to
2005 shows that overall payments to oncologists are up 20
Chairman JOHNSON OF CONNECTICUT. Would the gentleman yield
Mr. RAMSTAD. I yield to the Chairman.
Chairman JOHNSON OF CONNECTICUT. When you use those dates,
you include that big demonstration payment year. Yes, the
providers were kept whole that year. It is when you withdrew
the 30-percent increase and the 300 million in demonstration
and the small transition payment--when you say 117 percent
increase across the board, that was 117 percent of a little,
tiny payment that was for administration. It was never intended
to cover the costs of a whole staff, of pharmacy costs and all
the other things associated with delivering the care. That was
never the point of that original administration fee.
We grew a big cancer care capability because the drug
companies paid for administration, but they did not have to
turn to the government. So, that 117 percent does not really
mean anything. It does not tell us anything. Most of that is
the result of the fact that we included in the law that you pay
for oncology nurses when originally you were going to pay the
average nurse salary. So, his question which he originally
asked, why are we seeing this decrease, is the question we need
you guys to answer. That goes for anyone at the table.
Mr. KUHN. I appreciate that, and I would just say again
that the 117 percent increase is based on the factual data that
we got from oncologists in terms of practice experience and
then the work changes were based on the CPT panels. It sounds
like information that you all have that you referenced earlier
in your comments, Mrs. Johnson, and you, Mr. Ramstad, is new
data that we need to look at to make sure that we can reconcile
that you as the Committee, as you do your appropriate oversight
work here, can have apples-to-apples comparisons to make sure
that you make the decisions that you need to. We will look at
that and work with your staff on that.
Mr. RAMSTAD. I thank the Chairwoman--reclaiming my time--
for providing the proper context for that question. We need to
have further discussions, and certainly within the parameters
of our 5-minute exchanges here today we did not sufficiently
cover that. I want to ask one final question, Mr. Kuhn, and
this really was a MedPAC finding and corroborated, I think, by
the colloquy that the Chairwoman had with Dr. Miller. MedPAC
found that pharmacy facility costs are a substantial part of
total drug costs, and the Chairman verified that in terms of 25
to 28 percent of total drug costs. My final question, Mr. Kuhn,
why has no pharmacy facility code been created?
Mr. KUHN. On the issue of pharmacy handling fee, and the
physician community has talked a lot of issues about storage,
waste, you know, managing these complex drugs that are out
there, but, again, when we looked at the data that the
oncologists presented themselves to us where they really did
look at the issues of practice expense, we used the data that
they provided because it looked at the entire practice expense,
it brought the issues to the table, and we incorporated those
to the new relative value units (RVUs) that we have in the
Code. We believe that we have captured that information already
in the existing payments without having to create new codes.
Mr. RAMSTAD. Let me ask you this, a final question, and
thank you for your indulgence, Madam Chairman. Mr. Kuhn, I hope
you do sit down with some of the oncologists from Minnesota,
from the Mayo Clinic, University of Minnesota Hospital,
Fairview and others, Northwestern. I hope you do have a sit-
down with us and discuss your figures as well as their national
association. I would like to facilitate that meeting and get
you on the record as saying you would be happy to meet us.
Mr. KUHN. Absolutely be happy to meet with you.
Mr. RAMSTAD. Thank you very much. I yield back.
Chairman JOHNSON OF CONNECTICUT. I do want the record to
note that we have sat down with that kind of group with Dr.
Bark and never gotten any response. I handed the very charts
that he is referring to Dr. McClellan and others in your
office, and we have not gotten the response. We do need to
understand this because your testimony does not correlate with
our experience as Members of what is happening in our districts
to cancer care, and this is too important for that divide to be
Mr. RAMSTAD. Madam Chairwoman, I promise to invite you to
Chairman JOHNSON OF CONNECTICUT. Thank you. Mr. Hulshof.
Mr. HULSHOF. Thank you, Madam Chair. I also want to
associate myself with Mrs. Johnson's comments at the beginning.
We asked you specific things to do in research and reports to
do, and you have done that. Of course, some of you have gone
very close to the line in the report, and I can appreciate the
potential dilemma that you are in. On the other hand, as those
of us who return to our respective districts every week and we
hear, and, yes, perhaps anecdotally, but absolutely what Mr.
Ramstad said and what Ms. Johnson said is the real world. You
know, we know how we have gotten here. I remember in 1998 under
the previous administration, HHS--Health and Human Services
Secretary Shalala was talking about AWP and the abuse of it, so
there was a move afoot then. So, then we began to come up with
Let me just say for the record the reason that we have ASP
plus 6 percent is because of the gentlewoman from Connecticut,
because there was some discussion about not including the
practice expense, and it is only because of her tenacity is the
reason we have the plus 6 percent. Putting that aside, we
recognize, just as we have with the 1997 Balanced Budget Act
(BBA), (P.L. 105-33), that well-intentioned ideas sometimes
have very unintended consequences. That is why I hope you
aren't feeling, all of you, particularly you, Mr. Kuhn, that
this intensity from this side--and the record unfortunately
will not demonstrate the passion and the emotion with which we
bring these questions to you. It is not an attempt to put any
of you on the spot or to embarrass, but it is passion that--
because there are some people doing some lifesaving things back
home, and they want to continue to do it.
The fact is that 84 percent of cancer patients in this
country are seen at community clinics. This is not any judgment
toward those treatments that are done within the hospital
setting. Again, let me get off my soap box. Some of the
unintended consequences, for instance, on the prompt pay, the
community clinics are having to actually carry on their books
until they get reimbursed. They are required to pay. They don't
get the negotiated discounts between the manufacturers and the
wholesalers, and so then they are actually reimbursed for
something less than what they actually have to pay. So, one of
the suggestions, I think, from a later witness is to eliminate
prompt pay discounts from the ASP calculation. You may want to
comment on that.
You know, Missouri Cancer Associates in Columbia, Missouri,
opened their books. I requested they open their books and in
the month of March of this year, Mr. Kuhn--and I will pick on
you a little bit. They had a negative cost. Their clinic was in
the red for the month of March. So, when you project this out
then, you have retiring oncologists who are going to leave the
practice early, and then you have incoming residents who aren't
going to choose the field of oncology because they see the
current state of affairs, and so it is much more lucrative in
some other area of expertise. I think we are right on the cusp
of something that could be dire. So, again, that is my
Let me ask you this specific question, Mr. Kuhn. I think
Mr. Steinwald in the report--I am not sure that he said it in
his oral testimony--GAO has expressed concern that CMS does not
require manufacturers to report ASP information by purchaser
type. Is it your opinion that CMS has the administrative
authority to require manufacturers to report this information?
That is question number one. Question number two: Would it be
helpful to better assess claims that you stated, that 106
percent of ASP is insufficient--or perhaps our claims that 106
percent of ASP is insufficient? Let me go with those two. Do
you have the administrative authority to require that
information from manufacturers?
Mr. KUHN. On that one, I would have to get back to you, Mr.
Hulshof. I don't know whether we can collect the data in that
manner or not, but I would like to get back to you for the
record on that one.
Mr. HULSHOF. Do you wish to opine this further question as
far as how much of an administrative----
Mr. STARK. Would the gentleman yield for a moment?
Mr. HULSHOF. Sure.
Mr. STARK. I would like to join you in that. I thought that
was a question we would like to see that information as well,
and I commend the question.
Chairman JOHNSON OF CONNECTICUT. Return that to the whole
Committee, Mr. Kuhn.
Mr. KUHN. We would be happy to.
Mr. HULSHOF. As a quick follow-up along this line, and
perhaps you could do this in writing, not to put you on the
spot, I would anticipate that the manufacturers would say,
well, there is an administrative burden. So, I would like any
opinions you might have as far as an administrative burden that
this would represent, given the turnaround time that is
required. Again, I thank the Chairman for her indulgence.
Chairman JOHNSON OF CONNECTICUT. I would like to recognize
Mr. CAMP. Thank you, Madam Chairman. Mr. Kuhn, in the
Medicare Modernization Act there was a provision requiring CMS
to conduct a demonstration project for self-administered drugs
that were previously available only through a physician's
office. Congress also directed the department to submit a
report on the demonstration evaluating patient access to care,
outcomes, as well as an analysis of any cost savings to the
Medicare Program attributable to reduced needs for infuse-
related services. Can you tell me if this report has been
provided yet or when we can expect to receive CMS's evaluation?
Mr. KUHN. That particular provision was section 641 of the
MMA, and that report is currently in clearance within the
department. I wish I could give you a projected date when we
would have this up to Congress, but it is working through the
process, and we hope to have it to you very soon.
Mr. CAMP. At some point it would be interesting to know how
the agency would use these findings if, in fact, they found
that the use of self-administered alternatives led to
improvements in patient health outcomes and cost savings to the
Medicare Program to improve care for patients as well as
utilizing the program more efficiently. CMS has implemented a
new national coverage determination for physician-administered
drugs under Part B. Once a national coverage determination
(NCD) has been adopted by CMS, my understanding is that local
carrier coverage determinations are not relevant. If that is
the case, there is a carrier that is being permitted to
circumvent the intent of the NCD for a particular drug, and the
situation causes undue hardships for those dialysis patients
that fall within the region in which this carrier operates.
Does CMS have the authority to enforce NCDs once adopted, or
can any carrier ignore the intent of the NCD? Can you tell me
what steps are being taken to correct situations like these?
Problems--how long will it take to have problems like these
Mr. KUHN. I am somewhat familiar with this one, when you
mentioned that it was an end-stage renal disease (ESRD)
facility. I think it is a drug called Levocarnitine.
Mr. CAMP. Yes, it was.
Mr. KUHN. In 2002 or 2003, we did have an NCD, or national
coverage determination, on that particular product. My
understanding is that it is being implemented by our
contractors as implemented by the NCD. What I also understand
is that with varying practices' patterns by different ESRD
facilities, they run into issues in terms of how they come up
against this NCD. What I think this one takes, and what I
understand this one to be, there needs to be some further
education with the carrier, with the systemic autoimmune
rheumatic diseases (SARD) facilities so they understand exactly
what the standards are of the NCD, so that they understand how
it is being implemented as we go forward.
Two things. One, we will go back and be absolutely sure
that it is being implemented appropriately in terms of how the
NCD is put forward; but secondly, and more importantly, that we
have that communication and education between our contractor
and ultimately the providers to make sure that they understand
exactly the appropriate criteria as well.
Mr. CAMP. I certainly appreciate that because this
situation has led some beneficiaries in parts of the United
States to not have access to this particular drug, but also as
a result makes their dialysis treatments less effective. It is
very critical care. We have heard a lot about cancer treatment
which is critical, but dialysis treatment is critical as well.
Mr. KUHN. We will look at this, and I will also bring this
to the attention of our chief medical officer at CMS, who also
happens to be a nephrologist. We will have some first-line
expertise to look into this for you.
Chairman JOHNSON OF CONNECTICUT. Mr. Foley.
Mr. FOLEY. Thank you, Madam Chairman. I appreciate first
and foremost yours and Mr. McCrery's and other's work on IVIG.
It is critically important. Critically important. I repeat that
not only for effect, but for the understanding that this is
about 2 years old this problem. I am not on the Health
Subcommittee, and that is why I appreciate the gentlewoman
giving me a chance, because for a long time I thought the
failure to respond to some of our inquiries was only because I
wasn't on the health Committee. So, I am going to suggest, and
I have heard it repeatedly by members of this panel, that they,
too, have had trouble getting their calls returned.
This is an issue where people are dying. I came from a
Committee hearing with Mr. Camp, and we were talking about the
esoteric nature of the Tax Code. Nobody is going to die over
the Tax Code, but people are dying over IVIG. I can't seem to
get an answer. I keep hearing we are going to have facts from
manufacturers. We are going to have facts from doctors. I know
one thing: There is a critical crisis. Hospitals are stopping
providing it. We get various determinations of price, it is
this, it is that, but nobody can put their hands on this issue,
2 years old. Mr. Kuhn, I have a question. Based on your
discussions with FDA and others in HHS, do you believe there is
an IVIG product shortage?
Mr. KUHN. I will tell you, Congressman, an honest answer.
It will go week to week. FDA feels like there is a sufficient
supply, and it depends who you talk to last on this issue. I
will talk to one manufacturer who will say there is plenty of
supply. I will talk then to a distributor who will say that
there is insufficient supply. Right now, from what I can tell
from not only the manufacturing community, their trade
association, and the information we see from FDA, it looks like
there is sufficient supply in the marketplace right now,
though, however. . . .
Mr. FOLEY. Okay. Given that fact, sufficient supply in the
market, which would not be a supply/demand concern, why do you
think providers and distributors are selling their products 40,
50, 80 percent over ASP?
Mr. KUHN. This has been one of the most frustrating things
about this product, different from anything we have seen
before. What we have is a lot of it is encumbered. It is under
contract with different distributors who have it under contract
with various providers that are out there in the community.
This really seems to have restricted the free flow of product
within the marketplace, and what you see is the product moving
to the secondary market as a result of that with enormously
high markups, and it has created in some situations, some
For example, if a physician has a part of the supply
himself, and then he or she decides to send his patients over
to the hospital, and he keeps that supply of the product, he is
not shipping it with the patients, and we lead to dislocations
here. Again, what we understand is there is plenty of supply in
the marketplace. What we really see is this allocation problem
seems to be getting in the way of free flow of product in the
marketplace and helping it find its equilibrium so that
everybody gets the treatment they need and deserve.
Mr. FOLEY. Let me ask, if the doctor is holding back the
product in shipping his patient, what benefit is that on the
Mr. KUHN. There might be a chance to deliver that product
to another patient that might have a private payer that might
pay at a higher rate, for example, might be one of the
advantages there. We have heard that some manufacturers who
have done a very good job in terms of trying to make sure that
the product is getting to people that they have, they have seen
evidence of some of their products getting into secondary
markets. When they do, I think they are taking actions to make
sure that the product goes to patients and not to the secondary
market so that people can profiteer on this product in one way
Mr. FOLEY. So, let me get this straight. You are suggesting
that this doctor is shipping his patient to the hospital so
that they can provide the IVIG, and he is selling it to
somebody else for more money?
Mr. KUHN. I am saying there have been instances where this
has occurred. I would like to believe, and I think the evidence
is there, that this is truly the exception to the rule. What we
are seeing is that, as I think you indicated earlier, there are
a number of factors that are driving to again having this
product difficulty finding its equilibrium in the marketplace.
Mr. FOLEY. You mentioned at some point somebody did off-
market use or off-label use?
Mr. KUHN. Yes. There is a big surge in demand in terms of
off-label use. In Medicare we saw enormous increase in usage
between 2002 and 2004, a significant amount of usage. I think
what has happened is it is a wonderful product, and I think
others have mentioned that for the people who really need it,
it is absolutely essential. We are finding, and I think the
clinical evidence, and you will hear from the second panel,
there are new opportunities for use of this product that can be
very important and therapeutic to individuals, so that, too, is
exacerbating our problems as well.
Mr. FOLEY. I think you know now by the tone of the
Committee we are all very, very interested in this, and waiting
to the fall for answers is getting a little late.
Mr. KUHN. I hear you loud and clear.
Chairman JOHNSON OF CONNECTICUT. Thank you very much. As we
dismiss this panel, I would like to submit for the record and
call to your attention, Mr. Kuhn, the letter that I am sending
to Dr. McClellan today asking that CMS analyze claims dated
from 2003 to 2005 to see if there has been a change in the
proportion of cancer care provided in physicians' offices
compared to the hospital outpatient department, and then to do
the same with 2006 data when it comes in.
[The letter from Chairman Johnson follows:]
July 13, 2006
Honorable Mark McClellan
Centers for Medicare and Medicaid Services
Hubert Humphrey Building, Room.314-G
200 Independence Avenue, SW
Washington, DC 20201
Dear Dr. McClellan,
The Medicare Modernization Act (MMA) included significant changes
in Medicare reimbursement for cancer drugs and the costs associated
with administering these drugs. These changes were the result of
studies that concluded that the Medicare Program was overpaying for
cancer drugs. Since this time, there have been numerous c11anges to
oncology reimbursement including moving to an Average Sales Price (ASP)
methodology for the payment of drugs, an increase in chemotherapy
administration reimbursement rates, and two different demonstration
projects supplementing administration payments.
All of these changes have resulted in a reimbursement environment
that is in flux and uneven. I have received impressive reports from
oncologists that they are shifting the site of care for Medicare
beneficiaries without secondary insurance from the physician office to
the hospital outpatient department because there is no longer the
ability to absorb the 20% copayment loss in the individual practice.
Congress must know if this is in fact occurring, to what degree, and if
it is a result of reimbursement changes.
Consequently, I ask that CMS analyze claims data from 2003 to 2005
to determine if there has been a change in the proportion of cancer
care provided in the physician office compared to the hospital
outpatient department and report to me in writing on the findings.
Additionally, 2006 has resulted in another round of reimbursement
changes and I request that CMS also analyze and report the claims on
the first two quarters of 2006 as soon as this information is
I believe that this information is important to assessing the
appropriateness as well as the cost effectiveness of the current
reimbursement system and I look forward to reviewing CMS' s analysis of
the claims data,
Very truly yours,
Nancy L. Johnson
Member of Congress
Chairman JOHNSON OF CONNECTICUT. So, I think the Committee
could benefit from having that information in terms of trying
to find out what really is going on. As Dr. Miller recognized--
noted, those without secondary coverage do appear to be moved
to hospital settings, and since in some areas those settings
are not available, we need to understand whether we need to
take action to deal with this copayment problem. Do you think
you have the administrative action to deal with the copayment
issues that are coming forward?
Mr. KUHN. We do not believe we have the authority now for
the copayment issues and basically Medicare bad debt. It is
statutorily defined for hospital skilled nursing facilities.
There is nothing on the physician's side that gives us the
authority to do that at this time.
Chairman JOHNSON OF CONNECTICUT. Do we have the authority
to deal with the issue of lag, the difference between with when
prices change? Could you require that price could only be
changed at certain periods so that there wouldn't be this lag?
Mr. KUHN. I think we are pretty quick in terms of
information as it comes forward. Under most of the Medicare
payment systems, we do updates on an annual basis. On this one
we are doing it on a quarterly basis. We get the information--
the payment rates that we are using right now under ASP is
information that--from pricing from January, February, and
March of this year. So, right now it is pretty quick
turnaround, and compared to the other payment systems under the
Medicare Program, this is almost real-time data, at least for
the Medicare Program.
Chairman JOHNSON OF CONNECTICUT. Do you think people are
getting the payment if the price goes up within 3 months?
Mr. KUHN. We believe that the manufacturers understand how
to report the ASP data now. We are now into our seventh quarter
of it, and we think we are getting very accurate information
from them so that as prices move and change, I think they are
pretty reflective pretty quick. I think that is evidence in
terms of current ASP information that is out there. If you look
at the data, and some people look at it and go, oh, gosh, look
at the increases that we are seeing in July. Well, that is
because a lot of people raised prices in January.
Chairman JOHNSON OF CONNECTICUT. That is not a 3-month lag,
that is a 6-month lag, and you are absorbing that loss for 6
months, and if it happens to be one of the high cost and it
happens to be a high user, we can't just let the statistics
drive this. If it is a drug that is seldom used, it probably
does not matter much, but if it is a drug that is used
frequently, it could matter a lot. I think getting at some of
the things that Mr. Steinwald raised, but also looking at this
issue of frequency abuse. Why can't we make it? If we know the
information after 3 months, why can't we get the payments out
there in 3 months?
Mr. KUHN. When we get the reporting information--to give a
sense of the timetable, January, February, March of this year.
By the third or fourth week of April. We have the information
from the manufacturers in terms of reporting for that period of
time, and within 2 months those prices were posted. So, it is a
pretty quick turnaround.
Chairman JOHNSON OF CONNECTICUT. It is a total of 6 months
lag. We need to look at how you could shrink that down.
Mr. KUHN. We will look and see----
Chairman JOHNSON OF CONNECTICUT. You need look at who needs
to report when to get it shrunk down. Thank you very much. I
thank the panel for your attention and welcome the second panel
to testify. We will have votes coming up, so we will go through
the panel and then have questions. Dr. Frederick Schnell, Dr.
Joseph Bailes, Marcia Boyle, Richard Friedman, and Dr. Jordan
Orange. Dr. Schnell, if you would begin as soon as the name
plates are distributed.
STATEMENT OF FREDERICK M. SCHNELL, M.D., PRESIDENT, COMMUNITY
Dr. SCHNELL. Madam Chairman, Ranking Member Stark and
distinguished Members of the Ways and Means Subcommittee on
Health, good afternoon. My name is Fred Schnell, and I am a
practicing community oncologist from Macon, Georgia, and I
volunteer as the president of the Community Oncology Alliance
(COA). We believe that the cancer care delivery system in this
country is in grave danger of being dismantled. Changes in
Medicare reimbursement for cancer care brought about by the
Medicare Modernization Act of 2003 we believe to be too severe.
Community cancer clinics were shielded from the full impact of
these changes until 2006. Now reimbursement for both drugs and
services in many cases is less than our costs.
COA has reports of patient access problems from 37 States,
especially among seniors without adequate secondary insurance
who are unable to pay the 20 percent Medicare coinsurance
obligation. There are four simple solutions to correcting this
problem. First, eliminate prompt payment discounts from the
calculation of average sales price so that ASP is not
artificially lowered by financial discounts between
manufacturers and wholesalers. Second, remove the 6-month lag
in ASP so that community cancer clinics are not unfairly
subsidizing the Medicare system for such price increases. There
have already been over 35 price increases this year alone.
Third, create payment codes for essential services that
Medicare does not currently reimburse, most specifically for
treatment planning and pharmacy facilities. Fourth, restore
appropriate payment for drug administration and deal with the
reality of bad debt.
By not addressing the problem with Medicare reimbursement,
we are jeopardizing the future of cancer care in America and
threatening to undo all of the notable progress accomplished in
the war on cancer. The combination of earlier diagnosis, more
effective therapy, and widely accessible care has contributed
to the decreasing cancer mortality rate. Today, 84 percent of
people with cancer are treated in community cancer clinics just
like ours in Macon. No longer do cancer patients have to travel
great distances and bear economic hardships to be treated in
distant institutions. Instead they receive care in their own
communities close to home, family and friends. Prior to the
MMA, Medicare payments for cancer care were unbalanced.
Reimbursement for drugs subsidized a severe underpayment for
drug administration and essential medical services that cancer
patients require. However, the current reality with the MMA is
a significant difference between actual implementation and what
Congress had intended.
The CBO estimate for the MMA was a $4.2 billion reduction
in Medicare payments for cancer care from the year 2004 to
2013. Earlier this week, PricewaterhouseCoopers released a
revised analysis that estimates that $13.8 billion will
actually be cut from cancer care payments over this same time
period. This far exceeds congressional intent. What then
explains this sizable discrepancy of actual implementation and
congressional intent? The answer is threefold. First, Medicare
reimbursement for drug administration was initially increased
in 2004, but, as stated, has since actually decreased by a
factor of over 20 percent. The MMA increased reimbursement for
drug administration by 110 percent in 2004 as well as mandated
an additional one year 32 percent transition increase. This
appears to be a substantial increase; however, it was an
increase to an extremely low reimbursement rate and paled in
comparison to the cut in drug reimbursements.
Unfortunately, CMS did not create any new major payment
codes for unreimbursed services such as treatment planning.
What CMS did do was devalue payment for drug administration.
This devaluation has been compounded by the drastic cut to drug
reimbursement. Second, certain essential components of cancer
care are not reimbursed at all. For example, an essential part
of my day-to-day work involves the development of complex
treatment plans for my patients. Currently, no Medicare payment
exists for medical oncology treatment planning, although there
is reimbursement for treatment planning developed by radiation
oncologists Another example is that the cost of pharmacy
facilities are not reimbursed. These include storage,
inventory, pharmacy operations and waste disposal. These types
of services are subsidized by drug payments under the old
Medicare reimbursement system.
Third, drug reimbursement barely covers drug acquisition
costs and has decreased over 30 percent. Studies completed by
the OIG and the GAO on the adequacy of Medicare reimbursement
for cancer drugs ignore the reality that drug acquisition costs
is just a portion of total drug costs. In addition to pharmacy
facility costs, we incur bad debt from patients who lack
adequate secondary insurance and are unable to pay their 20
percent Medicare coinsurance. Bad debt, which averages 5.3
percent nationwide, is a growing reality for community cancer
clinics, especially as the cost of cancer drugs increases.
Whereas the patient copay for a high blood pressure medication
might be $5 or $10, the Medicare copay obligation for cancer
treatment can easily reach $5,000 to $10,000. We are ignoring
the fact that approximately 20 to 25 percent of Medicare
beneficiaries do not have adequate secondary insurance that
covers the expense of cancer treatment.
Furthermore, as I previously stated, the inclusion of
prompt pay discounts artificially lowers ASP, and community
cancer clinics are subsidizing Medicare for every price
increase. The Competitive Acquisition Program is not the answer
to the problems associated with Medicare drug reimbursement.
The oncology community at large use CAP as an untried and
untested experiment. We will not expose our patients to the
risks it presents. CAP will force the creation of individual
patient inventories, and increase the likelihood of treatment
errors and delays, and place new and unreimbursed
administrative burdens on our clinics.
In conclusion, community cancer clinics cannot operate when
reimbursement continues to be ratcheted down while operating
costs are increased by at least 4 percent per year. In 2006,
the impact of insufficient reimbursement has resulted in more
patients not being able to be treated because clinics cannot
afford to provide treatment that is reimbursed less than cost.
Seventy percent of the clinics from 37 States reporting are not
able to treat an increasing number of patients. As an example,
we just received notice from a clinic in Kentucky that is
unable to treat 25 to 30 patients per month due to, and I
quote, an overwhelming percentage of 20 percent coinsurance
turning into bad debt.
Unfortunately, the local hospital can treat only a very
limited number of patients, and treatment is being delayed by a
week or two. Additionally, clinics report closing satellite
facilities and practices often in underserved communities,
reducing professional staff, and very unfortunately being
pressured to factor economic decisions into cancer treatment
planning. If the situation continues without relief, we will
lose oncologists to attrition and retirement while seeing
increased rates of practice closings.
On behalf of every American with cancer, or caring for
someone with cancer, I implore the Congress to address the
growing deficiencies in the Medicare reimbursement for cancer
care. The problem that community cancer clinics face is
exacerbated by Medicare artificially setting the bar too low
and inviting private payers to cut their payments for cancer
care as well. We are already seeing this happen in my State of
Georgia. I finish with a question: As a nation, are we willing
to risk the future of the cancer care delivery system in this
country for an expense of less than half a penny per day per
American? Let us work together to finish the promise of
balanced reform promised in the MMA for cancer patients and the
community cancer clinics that provide them with the highest
quality care. Thank you, Madam Chairman, and your Committee for
allowing me to testify today.
Chairman JOHNSON OF CONNECTICUT. Thank you, Dr. Schnell.
[The prepared statement of Dr. Schnell follows:]
Statement of Frederick M. Schnell, M.D., President,
Community Oncology Alliance
Medicare Part B reimbursement for cancer care is insufficient in
2006. The implications of insufficient reimbursement are that community
cancer clinics report sending more patients to the hospital for
treatment, closing satellite facilities and practices, reducing staff,
and being pressured to factor economic decisions into the cancer
treatment plan in order for clinics to continue treating patients.
Additionally, clinics report considering dropping out of the Medicare
program. Already, in 2006, there are reports about access problems from
community cancer clinics in over 37 states.
The fundamental problem with Medicare Part B reimbursement in 2006
is that drug administration reimbursement has decreased by over 20%
since 2004 while drug reimbursement has decreased by over 30%. So,
during a time period when underlying medical costs are increasing
approximately 4% per year, reimbursement for both essential services
and drugs required to treat seniors covered by Medicare Part B
continues to decrease. Relating to services reimbursement, certain
services such as cancer treatment planning and pharmacy facilities are
not reimbursed. Relating to drug reimbursement, Medicare reimbursement
of Average Sales Price (ASP)+6% appears in cases to cover drug
acquisition costs. However, reimbursement for most cancer drugs is
actually less than cost when including the realities of pharmacy
facilities, prompt pay wholesaler discounts, bad debt, and manufacturer
price increases. Community cancer clinics, where 84% of the cancer
patients in the United States are treated, cannot continue to operate
in an environment where costs are exceeding reimbursement.
The specific problems with Medicare reimbursement are three-fold.
Problem #1. Medicare payment for drug administration is inadequate and
The Medicare Modernization Act (MMA) increased drug administration
payments by 110% starting in 2004. The MMA also created a lump-sum
transition increase of 32% that further raised drug administration
payments in 2004. This transition increase decreased to 3% in 2005 and
was eliminated in 2006. The purpose of this transition increase was for
the Centers for Medicare & Medicaid Services (CMS) to ascertain the
adequacy of existing payment codes and to create new codes for un-
reimbursed services, such as treatment planning.
Unfortunately, in 2004 no new major payment codes were created by
CMS for 2005; only temporary ``G codes'' were created. Instead, CMS
developed a chemotherapy demonstration project for 2005 that retained
at least $300 million in Medicare funding for cancer care. This stopgap
funding, along with the 3% transition fee and averted cut in the
physician fee schedule, minimized any impact on community oncology
during 2005. However, the chemotherapy demonstration project and
transition increase both expired at the end of 2005, which resulted in
lower Medicare reimbursement in 2006. Additionally, CMS replaced the
temporary ``G codes'' with new codes at a lower relative value unit
(RVU) rate and with no clear ``cross walk'' (i.e., translation) from
the ``G codes.'' This resulted in an additional decrease in drug
administration reimbursement. Exhibit A shows a coding analysis
performed by expert coders from around the country. Analyzing some
commonly used cancer treatment regimens, it is clear that reimbursement
for drug administration only (this analysis excludes drug
reimbursement) on a treatment-by-treatment basis has decreased
substantially from 2004 to 2006. This decrease is estimated to be in
excess of 20% overall.
The graph below illustrates the components of declining drug
administration for the CHOP/Rituxan treatment regimen presented in
Exhibit A. The purple portion of the bar in 2004 and 2005 illustrates
the impact of the transition increases--32% in 2004 and 3% in 2005. The
blue portion represents the underlying RVU-based payment.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
It is illogical that Medicare drug administration reimbursement has
decreased over 20% from 2004 to 2006 in light of the fact that medical
human resource and supply costs have actually increased by
approximately 4% per year during this period. It must be noted this has
occurred when drug reimbursement has decreased by over 30% with the
change from the prior AWP system to the new ASP-based reimbursement
Problem #2: Certain essential cancer care services and costs are not
The prior AWP-based reimbursement system resulted in drug
reimbursement overpayments that subsidized essential cancer services
that were either under-reimbursed or not reimbursed. Under the ASP-
based system there is neither a subsidy nor a direct or indirect
reimbursement for certain essential services. For example, cancer
treatment planning is not reimbursed as part of any existing Medicare
payment mechanism. It is ironic that radiation oncology treatment
planning, which is typically part of the overall cancer treatment plan,
is reimbursed by Medicare, whereas medical oncology treatment planning
is not reimbursed. As another example, all of the direct drug costs of
a pharmacy are not reimbursed. These include storage, inventory,
pharmacy operations, and waste disposal. In light of increasing
regulations dealing with chemotherapy and other toxic drug handing, the
costs of maintaining a pharmacy are increasing. However, these costs
are not reimbursed directly or indirectly.
Although some argue that many costs are ``bundled'' in the drug
administration payment codes, there is no evidence that this is true or
that these costs are appropriately covered by payment codes. In fact,
the existing codes for drug administration have not been updated--even
with the 2004 MMA 110% increase--to reflect the increasing costs of
simply administering cancer drugs, much less cover any other facets of
cancer treatment, such as treatment planning.
Problem #3: ASP+6% may only barely cover drug acquisition costs. It
does not cover all direct drug costs.
A clinic's total drug costs are comprised of drug acquisition
costs, pharmacy costs, billing and overhead, and bad debt. Analyzing a
clinic's drug acquisition costs in comparison to ASP+6% reimbursement
and concluding that reimbursement covers cost is a faulty analysis,
which is the problem with studies completed by the Office of the
Inspector General (OIG) and the Government Accountability Office (GAO).
The table below shows both OIG's estimated purchase price by drug
(column a) along with the corresponding drug reimbursement rate (column
b). If all of the patient's co-insurance was paid, most of the drug
acquisition cost is covered by the reimbursement (column c). However,
factoring in bad debt of 5.3% most of the drug acquisition costs are
not covered by the reimbursement (column d). On a case-by-case basis,
the impact of non-payment of the 20% co-insurance is substantial
(column e). If you factor in bad debt and selected other direct drug
costs, the result is a further under-reimbursement of drug costs.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
It is unreasonable to simply look at drug acquisition costs in
isolation without considering all direct drug costs. The stated
Medicare drug reimbursement rate is ASP+6%. However, factoring in other
costs, the effective real rate is ASP-3.8%. These include the MMA-
mandated inclusion of prompt payment discounts between the
pharmaceutical manufacturer and the wholesaler into the ASP
calculation; the impact of the lag between a manufacturer's price
increase and inclusion in the drug reimbursement rates; and the bad
Stated Medicare Drug Reimbursement Rate ASP+6%
Less Prompt Pay Discount 2.00%
Less Price Increase Lag 2.50%
Less Bad Debt 5.30%
Effective Medicare Drug Reimbursement Rate ASP-3.8%
Bad debt is a real cost incurred by community cancer clinics. COA
estimates bad debt at 5.3% nationally. An estimated 12% of patients
have no secondary co-insurance and in many states Medicaid--as the
secondary insurer--does not cover the patient's co-insurance
obligation. As the cost of cancer drugs escalate, patients are
increasingly unable to cover co-insurance payments that can run over
$20,000. Bad debt is a reality of operating a community cancer clinic,
yet it is ignored as a reality by CMS. Community cancer clinics
historically have been willing to treat patients rather than turn them
away or hand them over to a collection agency. However, community
cancer clinics now are increasingly unable to subsidize cancer care for
seniors covered by Medicare with no secondary insurance coverage.
This analysis does not include pharmacy costs. MedPAC estimated
pharmacy costs at 26-28% of total drug costs in analyzing actual costs
from outpatient facilities in Maryland. This analysis also does not
include the cost of capital in purchasing very expensive cancer drugs
or the costs of billing and overhead. Once again, under the AWP-based
system these costs were part of drug reimbursement. However, under the
ASP-based system only acquisition cost is reimbursed.
Some believe that the Competitive Acquisition Program (CAP) is a
solution to drug reimbursement problems. However, CMS has struggled to
find only one CAP vendor--after delaying the program because initially
there were no vendors--and few if any community cancer clinics will
trust an unproven, untested system to deliver the correct drugs on time
to their patients. The CAP will create multiple patient inventories,
risk treatment errors, and result in treatment delays. Additionally,
the CAP will actually increase pharmacy and billing costs because of
the procedures, tracking, and record keeping requirements. Analyzing
the top reimbursed cancer drugs, COA estimates that Medicare will
actually pay over 3% more for drugs to the CAP vendor than to community
These three problems have resulted in Medicare now becoming the
lowest payer for cancer care services. Medicare, with its considerable
market clout, has set reimbursement rates artificially low for private
payers to follow. In many cases, this is exactly what is happening.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
The congressional intent of the MMA was to save Medicare $4.2
billion from 2004-2013 by changing the reimbursement system for cancer
care, according to the Congressional Budget Office in a letter dated
November 20, 2003, to Chairman Thomas. Unfortunately, actual
implementation by CMS is resulting in substantially more cuts to
Medicare reimbursement for cancer care. Exhibit B is a report from
PricewaterhouseCoopers that estimates the cuts to cancer care
reimbursement to be $13.8 billion, far in excess of the $4.2 billion
intended by Congress. The graph below shows this discrepancy in
projected cuts (congressional intent) versus actual implementation by
CMS. The reasons for this discrepancy are the three problems previously
outlined in this document.
There is bipartisan recognition of this problem in both the House
and the Senate. The entire cancer community supports solutions to this
problem. There are currently three bills in the House addressing
aspects of this overall problem, including one with over 70 sponsors
that was introduced by Congressman Jim Ramstad, a member of the Ways
and Means Subcommittee on Health. There is an identical Senate bill
that was introduced by Senator Arlen Specter.
Some have suggested waiting to see more substantial patient access
problems before fixing the problems with Medicare Part B reimbursement
for cancer care. That is simply not acceptable because actual lives of
Americans are already being negatively impacted. Furthermore, we risk
dismantling a system of cancer care that has been built during the past
15-20 years. Rescuing the cancer care delivery system when it is too
late will not be feasible because the damage will be done. Already, the
incidence of cancer is increasing while the number of oncologists is
flattening. Reimbursement problems should not be motivating older
oncologists to retire, which is starting to happen, or discouraging new
physicians from pursing a specialty in oncology, which is also
happening at the medical school and fellowship levels.
On behalf of community oncology, we ask the Congress to immediately
fix the problems of insufficient Medicare reimbursement for cancer care
by at least accomplishing the following:
Eliminate ``prompt payment'' discounts from
pharmaceutical manufacturers' calculation of ASP. Prompt payment
discounts are financing discounts between the manufacturer and the
wholesaler--these are not incentive purchasing discounts to community
cancer clinics. Inclusion of these discounts in the ASP calculation
artificially lowers Medicare drug reimbursement by approximately 2%.
Immediately increase Medicare reimbursement for those
drugs increased in price by the manufacturer. Community cancer clinics
are currently subsidizing Medicare for all drug price increases for 6
months, on average.
Create payment mechanisms for un-reimbursed services such
as treatment planning and pharmacy facilities. Medicare reimbursement
needs to more realistically cover the essential services provided to
seniors by community cancer clinics.
Reevaluate existing drug administration payment codes to
restore adequate reimbursement that covers the costs of the materials
and human resources required to administer drugs.
Address the growing bad debt problem of Medicare patients
without adequate secondary insurance.
An independent analysis of the plight facing community oncology
appeared as a research article in the Journal of the National
Comprehensive Cancer Network (Surviving the Perfect Storm: An RVU-Based
Model to Evaluate the Continuing Impact of MMA on the Practice of
Oncology; Volume 4, Number 1, January 2006). The authors write, ``The
emotional and financial pressures facing the medical oncologist in
private practice are enormous, with no relief in sight. The complexity
of managing private practice oncology rivals that of managing cancer
care.'' ``Will the planned changes in Medicare reimbursement,
exacerbated by the loss of operational inefficient medical oncology
practices, lead to irreparable changes in the oncology delivery system
(e.g., access, availability, continuity, and quality)?'' Will the
United States abrogate its leadership in clinical cancer care and
research and default to a specialty of algorithm followers rather than
algorithm creators? Are the unintended consequences of changes in
regulation and reimbursement fully appreciated? And last and most
importantly, what are the risks to the cancer patient resulting from
the heuristic approach promulgated by regulators and legislators?''
Exhibit C presents a sample of quotes received from community
cancer clinics across the country.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
President Bush signed the Medicare Modernization Act (MMA) on
December 8, 2003. This legislation made significant changes in payment
for Part B prescription drugs. Under Section 303 (oncology) of the MMA,
Part B drugs, which previously were reimbursed at 95 percent of Average
Wholesale Price (AWP), were reimbursed at 85 percent of AWP in 2004 and
then, in 2005, reimbursed at a new pricing system called ``Average
Sales Price'' (ASP), under which reimbursement was set at ASP+6
percent. Finally, in 2006 and beyond, physicians will have a choice
between providing the drugs and being reimbursed at ASP+6 percent or
having these drugs provided by vendors selected in a competitive
PricewaterhouseCoopers (PwC), at the request of the Community
Oncology Alliance, estimated savings to the Medicare program from
changes in Part B reimbursement rates for covered outpatient oncology
drugs and oncology-related services under the MMA. Based on the most
recent information from the Medicare program, we estimate the savings
of $4.1 billion for the five-year period of 2004-2008 and $13.7 billion
for the ten-year period of 2004-2013 (as shown in Table 1 below).
These estimates are considerably higher than those estimated by the
Congressional Budget Office (CBO) in 2003 at the time of enactment of
the MMA. CBO estimated savings from Section 303 of the MMA at $0.9
billion for the 2004-2008 period and $4.2 billion for the 2004-2013
period, or about one-third PwC's estimate for the same period.\1\ The
differences in estimates are not surprising. CBO's 2003 estimate was
based on their best information at that time, which did not include any
specific information on ASP. In constructing our estimate, we had
access to actual ASP information for 2005-2006 from the Centers for
Medicare and Medicaid Services (CMS).\2\
\1\ Congressional Budget Office. H.R.1 Medicare Prescription Drug,
Improvement, and Modernization Act of 2003. November 20, 2003.
\2\ Our savings estimate does not include indirect effects on the
federal outlays for the Medicare Part B premium, Medicare Advantage,
and the Medicaid program. CBO did not show these offsets separately for
individual sections of the MMA but, instead, folded together all the
offsets of dozens of other programs and reported the overall offset.
Table 1. Federal Budgetary Cost of the MMA Payment Changes to Oncology Outpatient Drugs and Biologicals (Fiscal
Years 2004-2013, in $ billions)
2004 2005 2006 2007 2008 2004--2008 2004--2013
PwC's 2006 estimate 0.1 (0.5) (1.0) (1.3) (1.4) (4.1) (13.7)
CBO's 2003 estimate 0.1 (0.1) (0.2) (0.3) (0.3) (0.9) (4.2)
Difference (0.0) (0.4) (0.8) (0.9) (1.1) (3.2) (9.5)
PricewaterhouseCoopers estimate, July 10, 2006.
In 2004, Part B oncology drugs were reimbursed at 85 percent of AWP
under the MMA, compared to 95 percent of AWP in absence of the MMA. To
calculate the spending after the change in drug pricing, we took the
drug portion of the baseline and applied the 85 percent in place of the
previous 95 percent for branded drugs. This reduced drug spending by
$0.5 billion. However, the reduction in drug payments was offset by the
increase in payments to physician fee schedules under the MMA.
Consequently, estimated payments in 2004 were virtually unchanged by
In 2005, we estimated the new ASP+6 percent pricing system would
reduce oncology drug payments by about 30 percent, based on new
information from CMS. We applied this percentage to the baseline 2005
drug spending. This price reduction resulted in savings of $1.8 billion
in drug spending. In the meantime, physician fees spending was
increased by $0.4 billion. The combined impact of the MMA on oncology
Part B spending would be gross savings of $1.4 billion. These gross
savings would result in fiscal year savings of $0.5 billion to the
Medicare program for 2005 after accounting for behavioral offsets, cost
sharing, and conversion from calendar year to fiscal year.
Starting in 2006, physicians will have a choice of whether they
purchase drugs and receive the ASP pricing system or have the drugs
distributed by vendors selected through a competitive bidding process.
We have assumed that all physicians will be reimbursed by the ASP
pricing system. This is a conservative estimate of potential savings
because our assumption is that Medicare would pay ASP+6 percent rather
than the lower competitive amount. In 2006, the reduction in drug
spending was estimated at about 35 percent, based on the first three
quarters of ASP+6 percent information. Total impact of the MMA on
oncology Part B spending was estimated to be gross savings of $2.2
billion, or $1.0 billion in fiscal year savings to the Medicare program
after accounting for behavioral offsets and cost sharing.
In 2007 and thereafter, the reduction in drug spending was assumed
at 32 percent, the average of that of 2005 and 2006. We have also
incorporated in our estimate proposed changes by CMS in work relative
value units (RVUs) and practice expense (PE) RVUs affecting payments to
physician services. These revisions are proposed to be effective
starting January 1, 2007. Specifically, CMS estimated that the combined
impact of work and PE RVUs changes would increase oncology physician
fee schedules by 3 percent in 2007 (first year of PE transition) and by
2 percent in 2010 with full PE implementation.
We estimated the total savings over the five-year period (2004-
2008) to the Medicare program would be about $4.1 billion and the ten-
year period (2004-2013) would be about $13.7 billion, as reported in
``On an average we are sending 25-30 patients to the hospital a
month for their chemotherapy treatment and growth factor support due to
an overwhelming percentage of 20% coinsurance turning into bad debt.
Facilities, however, are providing a very limited number of open chairs
for patients which means patients are being delayed a week or two
waiting on an open chair.''
``We have only been able to send one patient to our local hospital
due to the fact that they are refusing to accept Medicare, Medicaid,
self pay, and managed care Medicaid patients based on the following
factors: they are not set up for chemotherapy infusion; they do not
have the staff needed; and last, they are not budgeted for the
additional financial burden. We are still in negotiations with these
hospitals and will let you know when/if we have a resolution.''
``We have a practice that is unable to take on every referral. Two
years ago we stopped doing second opinions, and rarely had to turn down
new patients. This year we have turned down more new patients than ever
in the history of our 15 years in this town--we no longer do self-
referred patients, and cannot always take on new patients referred by
physicians. Thus, we do not take any HMO's or any MediCal. Because
chemotherapy is so expensive, we have stopped taking any dual
eligibles. Many more patients have been hospitalized for chemo in our
town than were three years ago, and that clearly is because the drugs
are unaffordable, both to patients and doctors. If one of five Avastin
patients fails to pay their 20%, our practice could go out of
We are looking toward closing one of our offices. We can no longer
cover the overhead of the practice due to the inadequate payments of
ASP+6%. The other reimbursement schedules are grossly inadequate. We
have already cut staff. Medicare D for oncology patients is a
catastrophe. Most cannot afford the co-pays on these very expensive
drugs. They are priced out of effective medications such as the TK
inhibitors, Revlamid, etc. THERE IS A NEW WRINKLE! Medicare is now not
denying our claims but ``PENDING'' all claims for Rituxan, Aranesp, and
Herceptin--thus they delay payment for three to four months. This has
wiped out all of our money. We cannot purchase any more drugs! We will
now be sending all patients to the hospital 10 miles away for
chemotherapy. Does Medicare wish to eliminate the private practice of
``It seems that CMS excluded our specialty number 98 from yet
another fix in their system. We still have not been paid from the first
oversight which was the 2006 demonstration project, but to add insult
to injury, a much worse problem has occurred and it seems that I cannot
make any progress no matter what I do. Medicare has been pending all of
our claims that include Aranesp, Procrit or Neulasta charges. They
request medical records. They pend the entire claim to include any
chemo drugs that may be included. We have not been paid this entire
year for these drugs. I have stopped sending my claims for these
services hoping to prevent this process and hold up on any additional
``We did cost analyses on each chemo protocol based on each drug
cost and overhead. This was done using our most common secondary
reimbursements. Based on this, a list was sent to staff indicating
which protocols were underwater. These are the treatments sent out.
What was found was that without a secondary, in most cases with
Medicare, we were underwater with some exceptions.''
``We can't afford to treat patients that cannot pay their 20%.
Right now 26 of 64 drugs we commonly give are underwater at 100% of
Medicare. Also, the hospitals are seeing more and more patients in
their outpatient units. We are in a high competition area, and a lot of
the Oncologists in this area are sending patients to the hospital for
``When we treat patients without secondary coverage we put a
financial burden on these patients. This is not the time to cause more
stress; this is the time to allow the patient to heal. One example of
financial stress is colon cancer; the treatment cost is $8,000 every
two weeks for 12 treatments. Patient responsibility is 20%, or $1600
per treatment or $3,200 per month. If they cannot afford secondary
insurance, how can they afford $3,200 per month for six months
($19,200)? The clinic is to collect this amount. The clinic is not a
collection agency. A pharmacist once said to me as I tried to call in a
drug that cost $1,200, why would I loan the patient a thousand dollars
while the government decides to pay me? This $19,200 is a loan that
many times is paid in $50 and $100 installments. Maybe the government
could loan the money to these patients so we can go back to assisting
the patient in health care.''
``We do see the Medicare only patients for OV and labs but refer
them to the hospital for any treatment because most of our drugs will
be in the red if we receive only 80% of the Medicare allowable. Most of
our patients who only have Medicare do so because they cannot afford a
secondary/supplemental--thus, cannot afford or will not pay the co-pay.
We service western Kentucky which has a lot of the ``working poor'' who
cannot even afford their employer's healthcare premiums and southern
Illinois that is just poor with a very high percentage of Medicaid.
Chairman JOHNSON OF CONNECTICUT. Dr. Bailes.
STATEMENT OF JOSEPH S. BAILES, M.S., EXECUTIVE VICE PRESIDENT,
AMERICAN SOCIETY OF CLINICAL ONCOLOGY, ALEXANDRIA, VIRGINIA
Dr. BAILES. Thank you. Good afternoon. I am Dr. Joseph
Bailes, a medical oncologist from Houston, Texas, representing
the American Society of Clinical Oncology, or ASCO. ASCO is the
medical society for physicians and other health care
professionals involved in cancer treatment and research, with
more than 24,000 members worldwide, a third of whom are
practicing community oncologists in the United States. ASCO has
for many years been concerned about imbalance in Medicare
payment methodology, with emphasis on drug payment and too
limited emphasis on payment for services. With the passage of
MMA, Congress moved toward resolving these imbalances, but
problems remain which are causing disruptions in care, and we
believe that more needs to be done.
ASCO believes that the average sales price, or ASP, system
has the potential to reflect appropriately the cost of
acquiring drugs. As currently structured, however, the system
does not ensure that all physicians can purchase chemotherapy
drugs without suffering financial loss that would threaten the
access of patients to some therapies. Although last year's
inspector general report characterized reimbursement as
generally adequate, the report shows that for about half of the
drugs reviewed, at least 20 percent of physicians incurred out-
of-pocket loss to obtain the drugs. ASCO believes that this
shortfall in Medicare payments will create access problems;
therefore, ASCO supports creating a floor for Medicare payments
to ensure that it is not lower than the widely available market
In addition, ASCO supports excluding prompt pay discounts
to wholesalers and distributors from the calculation of ASP.
Including prompt pay discounts received by wholesalers and
distributors distorts the calculation, and it contributes to
situations in which individual physicians are unable to obtain
some chemotherapy drugs at or below the Medicare payment rate.
It is for these reasons that ASCO strongly supports H.R. 5179,
introduced by Representative Ralph Hall, as a means of bringing
Medicare payments into better alignment with market prices and
thus avoiding access challenges for patients.
To be complete, reimbursement reform must address not only
overpayment for drugs, but also underpayment for physician
services. While MMA made some adjustments to payment for
services, we believe that further changes are required to
recognize services not currently reimbursed by Medicare. ASCO
supports the establishment of a new Medicare service for
comprehensive care planning and coordination at the time of
diagnosis, at the end of active treatment, or when there is a
change in the cancer survivor's condition or care. Such a
service is supported by a series of recommendations by the
Institute of Medicine. H.R. 5465, introduced by Representatives
Davis and Capps, proposes such a service and ASCO is supporting
that bill as well.
ASCO continues to be concerned about the CMS methodology
for determining practice expense relative values. Both the GAO
and the Lewin Group, a CMS contractor, have issued reports
concluding that the CMS methodology of allocating practice
expense relative values for indirect costs is biased against
services that do not involve physician work. We are also
concerned by the proposal published by CMS on June 29, 2006, in
which CMS would disregard certain survey data in determining
practice expense relative values. We urge the Committee to
review carefully the CMS proposal and offer guidance to the
agency regarding alternative approaches that will sustain
necessary cancer care services.
The oncology demonstration projects administered by CMS in
2005 and 2006 provide additional resources for oncology
practices, but are also yielding data contributing to quality
improvement efforts, including CMS's development of future pay-
for-performance programs in cancer care. It has been suggested
by cancer experts and third-party payers that the current
demonstration project will have value only if it provides
sufficient longitudinal data to enable meaningful analysis and
direction for future quality improvement efforts. We urge the
Committee to support a multiyear extension of the demonstration
project to enable collection of enough data to guide quality
Patient coinsurance, as you have heard, is an issue for
Part B drugs. ASCO agrees with MedPAC that the coinsurance
problem needs to be addressed. The 20 percent coinsurance
requirement is frequently an unreasonable burden on cancer
patients who are treated with state-of-the-art medicines.
Congress should resolve this issue by eliminating, or at least
significantly reducing, the patient burden of coinsurance for
Part B drugs. We appreciate the interest of the Committee in
scheduling the hearing, and we anticipate working with you to
continue improvements in reimbursement and quality of care for
the benefit of our patients and enhanced efficiency of the
Medicare Program. Thank you, Madam Chairman.
[The prepared statement of Dr. Bailes follows:]
Statement of Joseph S. Bailes, M.D., Executive Vice President, American
Society of Clinical Oncology, Alexandria, Virginia
Good afternoon, I am Dr. Joseph Bailes, Interim Executive Vice
President and CEO of the American Society of Clinical Oncology, or
ASCO, and a medical oncologist from Houston, Texas. I am pleased to be
here on behalf of ASCO to address issues related to Medicare payment
for Part B drugs and related services.
ASCO is the medical society for physicians and other health care
providers involved in cancer treatment and research. With more than
24,000 members worldwide--and a third of those members in private
practice in the United States--ASCO is the leading voice of oncology
professionals on matters of quality cancer care and access.
The issues under consideration today are familiar to ASCO. We have
been engaged in the debate over reform of reimbursement for cancer
therapy for at least 15 years, since around the time that ASCO first
established a Washington office. We have long been concerned about
imbalances in payment methodology, with too much emphasis on drug
payment and too little on payment for services.
With the passage of the Medicare Modernization Act of 2003, or MMA,
Congress attempted to resolve those imbalances. However, with a change
of this magnitude it is not surprising that there are some problems.
This hearing provides an opportunity to air some of the continuing
concerns under MMA so that we can work together to assure both quality
cancer care for our patients and responsible reimbursement policy for
the federal Medicare program. We are here to share with you our
thoughts about how to achieve both.
Payment for Drugs
We appreciate that the ``average wholesale price,'' or AWP, system
was an unbalanced method of compensating oncologists for cancer care
under Medicare. As currently structured, however, the system of
``average sales price,'' or ASP, does not ensure that all physicians
can purchase chemotherapy drugs without suffering financial loss that
threatens the access of patients to some therapies.
In September 2005, the HHS Office of Inspector General (``OIG'')
issued a report finding that reimbursement for drugs under the ASP
system was ``generally adequate.'' The report found that, for 35 of the
39 drug codes analyzed, the average amount paid for drugs was less than
the Medicare reimbursement amount. For 4 of the 39 drugs, the average
amount paid for drugs exceeded the reimbursement amount.
The OIG's conclusion that reimbursement was ``generally adequate''
and its analysis based on average drug costs to physicians do not
appropriately consider the many situations faced by particular
physicians in which the Medicare payment amount does not cover the cost
of the drugs. Although the OIG's conclusions did not highlight this
problem, the report shows that for 17 of the 39 drugs reviewed, at
least 20 percent of physicians incurred an out-of-pocket loss. Only 3
of the 39 drugs could be obtained by all physicians at the Medicare
payment amount or less. The OIG's conclusion fails to acknowledge that
out-of-pocket losses are incurred by physicians in many circumstances,
a situation that threatens access to care for some cancer patients. In
some of those circumstances, practices are referring patients to
hospital outpatient departments. We have received reports from ASCO
members that, in some instances hospitals are not accepting those
patients. This is a particular challenge to patients without secondary
To avoid the potential access problems created by this shortfall in
Medicare payment, ASCO supports legislation that would ensure that the
Medicare reimbursement amount is sufficient to cover what physicians
have to pay to obtain drugs. Legislation introduced by Representative
Ralph Hall, H.R. 5179, would create a floor for Medicare payment to
ensure that it is not lower than the ``widely available market price.''
The Medicare statute is currently asymmetrical in that it allows the
Centers for Medicare & Medicaid Services (``CMS'') to lower the payment
rate when it exceeds the widely available market price but does not
permit raising the payment rate when it is less than the widely
available market price. This inconsistency should be rectified
The statute defines the widely available market price as ``the
price that a prudent physician or supplier would pay.'' We believe that
a physician who shops among the distributors of oncology drugs for the
lowest price is a prudent buyer. If that physician cannot obtain a drug
for the Medicare payment amount through that process, Medicare needs to
revise the payment amount.
H.R. 5179 would also exclude prompt pay discounts to wholesalers
and distributors from the calculation of ASP. This change is analogous
to the change in the definition of ``average manufacturer price'' that
was enacted by section 6001(a)(2) of the Deficit Reduction Act of 2005
(``DRA''). Under the DRA, average manufacturer price will be used
beginning in 2007 to set the upper payment limit for reimbursement to
pharmacies for drugs reimbursed by Medicaid.
The DRA, however, excluded prompt pay discounts extended to
wholesalers from the calculation of average manufacturer price of this
purpose, presumably because pharmacies do not receive those discounts.
The same principle should apply under Medicare Part B. Including prompt
pay discounts received by wholesalers and distributors distorts the
calculation and contributes to situations in which individual
physicians are unable to obtain some chemotherapy drugs at or below the
Medicare payment rate.
We strongly support H.R. 5179 as a means of bringing Medicare
payment into better alignment with market prices and thus avoiding
access challenges for patients.
Payment for Related Services
The MMA made some adjustments to payment for services but they were
not sufficient to cover the cost of providing the full range of
services required for comprehensive cancer care. Further legislative
changes beyond those in MMA are required to recognize services not
currently reimbursed by Medicare. In addition, CMS must revise the
manner in which it is calculating the practice expenses associated with
Payment for Coordination of Cancer Care
One very important payment reform is embodied in legislation
introduced by Representatives Lois Capps and Tom Davis. Inspired by a
series of recommendations from the Institute of Medicine (``IOM''),
H.R. 5465 would establish a new Medicare service for comprehensive
cancer care planning and coordination at the time of diagnosis, at the
end of active treatment, or when there is a change in the cancer
survivor's condition or care.
The care planning service was recommended by the original IOM
cancer care quality report in 1999, and the most recent report on adult
survivorship issues in 2005 underscored the importance of coordination
of care as the survivor moves from active treatment to a period of
monitoring side-effects of treatment and possible second cancers. By
paying oncologists for comprehensive care planning, the quality of
cancer care will be enhanced, patient satisfaction will be boosted, and
cancer care resources will be more efficiently utilized.
Practice Expense Relative Value Methodology
ASCO continues to be concerned about the CMS methodology for
determining practice expense relative values consistently with MMA. A
CMS contractor, the Lewin Group, and the Government Accountability
Office have both issued reports concluding that the CMS methodology of
allocating practice expense relative values for ``indirect'' costs is
biased against services that do not involve physician work. We believe
that drug administration services, which are considered to involve
little or no physician work, are adversely affected by the current
methodology. CMS, however, has not revised its method of calculating
practice expense relative values to remedy this bias.
Our concern about the calculation of practice expense relative
values has been heightened by the proposal published by CMS on June 29,
2006. The MMA required CMS to use the supplemental survey of
oncologists' expenses sponsored by ASCO to determine practice expense
relative values. However, under CMS's proposal, surveys would no longer
be used to determine the practice expense relative values attributed to
the ``direct'' costs of clinical staff, supplies, and significant
equipment. In addition, CMS is proposing to change the method of
determining the practice expense relative values attributable to the
``indirect'' costs of administrative staff and overhead. We do not
believe that CMS has discretion to discount or disregard this survey
data in determining practice expense relative values for drug
administration services performed by oncologists.
ASCO has just begun its analysis of CMS's proposed changes, but we
are concerned about proposed decreases in payments for many drug
administration services. For example, the practice expense relative
value units assigned to the key service of a chemotherapy infusion
(first hour) would decline by 13 percent. It is important that the CMS
methodology result in appropriate payment amounts for drug
administration services that are adequate to support the services and
consistent with the intent of Congress in MMA. We urge this Committee
to review carefully the CMS proposal and offer guidance to the agency
regarding alternative approaches that will sustain necessary cancer
Demonstration Projects and Quality Cancer Care
The oncology demonstration projects administered by CMS in 2005 and
2006 have provided additional resources to permit oncology practices to
provide high quality cancer care. In addition, these projects have
yielded useful data for assessing the quality of cancer care and
contributing to quality improvement efforts. The current demonstration
project assesses compliance with cancer guidelines, an initiative that
holds promise not only for enhancing cancer care quality this year but
also in guiding the development of future ``pay-for-performance'' in
ASCO is collaborating with CMS, other government agencies, patient
advocates, and third-party payers in the Cancer Quality Alliance, a
voluntary alliance that addresses issues of quality care in oncology.
In this setting, it has been suggested by experts that the
demonstration project will have value only if it provides sufficient
longitudinal data to enable meaningful analysis and direction for
future quality improvement efforts. We would urge the Committee's
support for a multi-year extension of the demonstration project to
enable collection of enough data to support well-informed quality
Competitive Acquisition Program
The MMA also enacted a Competitive Acquisition Program (``CAP'')
under which physicians can obtain drugs from a Medicare contractor for
specific patients, and the contractor is responsible for billing the
Medicare program and the patient. One purpose of the CAP was to meet
the needs of individual physician practices that, for whatever reason,
find themselves unable to purchase drugs through traditional channels
at acceptable prices. We believe there may be a legitimate role for the
CAP, but as currently configured, there are still significant issues
that need to be addressed with the program.
A primary concern is the fact that the rules permit CAP vendors to
terminate access to drugs for patients who fail to pay their
coinsurance within 45 days. This provision is an unexpected and
unwelcome burden for cancer patients. Oncologists in practice
frequently face the necessity to deal with unpaid coinsurance,
sometimes absorbing the loss, sometimes extending payment terms, and
sometimes referring patients to charitable organizations. All these
options are open to CAP vendors, and they should not be absolved from
those options any more than oncologists. Arguably, one of the reasons
oncologists may avoid CAP is the potential harm to their patients from
this provision, which should be revisited without delay.
Another potentially inhibiting factor for oncologists is the
failure of CAP to reimburse practices for the administrative costs
associated with the program. Our members tell us that there would be a
significant new administrative burden in dealing with the CAP
contractor. Since there would be no additional reimbursement to cover
these costs, that factor may be discouraging for practices as they
decide whether to enroll in the program.
Other issues of concern include the rule that a physician may not
transport CAP drugs from one practice location to another. This rule
can interfere with the operation of practices with multiple offices.
Also, the CAP rules establish a vague negotiation process for the
physician and the CAP vendor to work out the disposition of unused
drug. It would probably encourage enrollment in the CAP if this process
Patient coinsurance is an issue not just in CAP but also in Part B
generally. Cancer drugs can be very expensive, and the 20 percent
coinsurance can amount to many thousands of dollars for a course of
treatment. Patients who lack secondary or supplemental insurance are
often hard pressed to pay the coinsurance involved.
In a report issued by the Medicare Payment Advisory Commission
(``MedPAC'') in January 2006, however, MedPAC noted that patients who
are unable to cover their coinsurance are increasingly being referred
to hospitals. Medicare pays 70 percent of the bad debt incurred by
hospitals. MedPAC also stated that it plans to study long-term
solutions to this problem.
ASCO agrees with MedPAC that this problem needs to be addressed.
Although the 20 percent coinsurance requirement is appropriate for many
types of services covered by Medicare, it is frequently an unreasonable
burden on cancer patients who are treated with state-of-the-art
medicines. Congress should resolve this issue by eliminating, or at
least significantly reducing, the patient burden of coinsurance for
Part B drugs.
* * * * *
As the issues raised in this hearing amply reflect, Medicare
reimbursement for cancer care is as complex and challenging as ever.
ASCO has provided its members a wide range of tools and services to
help them adjust to this rapidly changing environment. Among these are
the Quality Practice Oncology Initiative, practice management
workshops, practice guidelines, and a hotline for Medicare policy
questions. We are happy to share information about these and other
similar efforts at a later time.
There remain many potential pitfalls before we achieve a
reimbursement system that ensures comprehensive quality cancer care. We
appreciate the Committee's interest in scheduling this hearing and are
committed to working with you to continue improvements in reimbursement
and quality of care for the benefit of our patients.
Chairman JOHNSON OF CONNECTICUT. Thank you. Ms. Boyle.
STATEMENT OF MARCIA BOYLE, PRESIDENT, IMMUNE DEFICIENCY
FOUNDATION, TOWSON, MARYLAND
Ms. BOYLE. Chairwoman Johnson, Ranking Member Stark and
Members of the Subcommittee, thank you for inviting me today to
testify on behalf of patients who depend on intravenous
immunoglobulin, or IVIG, for their very lives. I would like to
especially thank Congressman McCrery for his long-time support
of our patient community. As president of the Immune Deficiency
Foundation, I represent approximately 50,000 patients across
America who need IVIG as their only lifesaving therapy.
However, today, I am speaking on behalf of all patients who
My son John is one of those patients. He was born without
the ability to produce antibodies. Fortunately, he receives
IVIG, a plasma-derived therapy, every 3 weeks to replace this
essential component of his immune system. How good is this
treatment? At 28 years old, with regular infusions of IVIG, he
is married, has a demanding career and is a healthy and
productive member of society. Meeting him and others like him,
you would never know there was a problem. Without this therapy,
he would probably not be alive or he would be severely
disabled. IVIG prevents infections in the immune-compromised,
and there is no alternative therapy. The thought of his not
having access to IVIG is a nightmare. Unfortunately, patients
have been living this nightmare and are in despair. When the
new ASP formula went into effect on January 1, 2005, my office
started hearing from several thousand Medicare patients and
physicians who could no longer receive or administer IVIG
because physicians could not afford to continue treating at the
reduced Medicare rates.
During 2005, many of the Medicare patients were shifted to
hospitals, away from their physicians, their trained nurses and
their usual brand of IVIG, and many suffered serious reactions
to different brands. Some were hospitalized and many had
increased infections. When you think about it, the worst place
for an immune-compromised outpatient is in the hospital exposed
to infections. In fact, I believe it is the most expensive site
of therapy. Patients who were not successfully transferred to
hospitals were denied access to IVIG altogether, particularly
those without Medigap or secondary insurance. We don't even
know what has become of many of these patients. Those that we
do know of have been seriously ill.
Working with other concerned groups last year, we advocated
for access in all sites of care and begged Congress and CMS to
not reduce the reimbursement rates for the hospitals to the
levels of the physician outpatient setting because that would
remove the last site of care. However, on January 1, 2006,
hospitals were also switched from the AWP to the ASP formula.
Although we hoped our predictions would not be true, many
hospital outpatient clinics have stopped treating with IVIG
because it is too costly to continue treating. Patients in some
States have been particularly devastated, particularly those in
Texas, Nebraska and Florida, where few hospitals remain that
treat with IVIG. The impact of Medicare reimbursement doesn't
stop with Medicare patients. In recent months, we have heard of
more private insurance carriers reducing their rates to those
of Medicare, now endangering the lives of children. While the
medical details are different, the medical outcome is the same
as taking chemotherapy away from a cancer patient or insulin
away from a diabetic.
The HHS Blood Safety Advisory Committee in May of 2005
recommended that the Secretary declare a public health
emergency to restore access to IVIG. He did not. Sadly, Pam
Way, one of the patients who testified about losing access to
IVIG and literally begged for her life, has died as a result of
this situation. In September of 2005, the advisory Committee
once again recommended that the Secretary declare a public
health emergency. In response to the two recommendations, 28
Members of Congress sent a letter to Secretary Leavitt
requesting that he declare a public health emergency. Once
again, IVIG access was not restored.
A few weeks ago, 58 Members of Congress sent a letter to
Secretary Leavitt requesting that he declare a public health
emergency. I thank Congressmen McCrery and Foley for their
leadership in this effort, as well as the Members of the
Subcommittee who signed onto this letter. It is truly a
national disgrace that this problem has persisted for more than
a year and a half and government has done nothing to restore
access to our patients. Members of this Committee, how many
more patients have to suffer, how many more patients have to
die, for the government to recognize this public health
emergency? I implore the Committee to take emergency action
today to restore access to IVIG in all sites of care. Please
end the nightmare that has devastated our community. Once
again, thank you for including the problem of IVIG in today's
[The prepared statement of Ms. Boyle follows:]
Statement of Marcia Boyle, President, Immune Deficiency Foundation,
Chairwoman Johnson and Members of the Subcommittee, thank you for
inviting me to testify on behalf of patients who need Intravenous
Immunoglobulin replacement in order to stay alive. I would like to
specially thank Congressman McCrery for his long-time support in
helping to improve the lives of patients with primary immune deficiency
diseases. Please know that although I represent the primary immune
deficiency community, today I am speaking on behalf of all patients who
require IVIG as their lifesaving therapy.
As president of the Immune Deficiency Foundation, I represent more
than 50,000 patients across America who need IVIG as their only
lifesaving therapy. My son is one of these patients. Like other PID
patients, he was born without the ability to produce antibodies. He
receives IVIG every three weeks to replace this essential component of
his immune system. How good is the treatment? At 28 years old, with
regular infusions of IVIG, he is married, has a demanding career, and
is a healthy and productive member of society. Without this plasma-
derived therapy, he would not be alive, or would be kept alive through
antibiotics fighting infection after infection, and be severely
disabled with a poor quality of life. IVIG prevents infections in the
immune-compromised. There is no alternative therapy. The thought of his
not having access to IVIG would be an unacceptable nightmare.
Unfortunately, many patients have been living this nightmare. Since
January 2005, IDF has received thousands of calls, emails and letters
from Medicare patients and physicians, who have not been able to
receive their IVIG infusions at their physicians' offices, outpatient
infusion suites, home care settings and hospitals. About 20% of our
patients are on Medicare. During 2005, many of the Medicare patients
were shifted to hospitals where many were admitted for 23 hours and
most were not receiving the most appropriate brand of IVIG, but rather,
the brand the hospital had accessible. Patients who had not been
successfully transferred to hospitals, especially those who did not
have Medigap or secondary health insurance policies, were denied access
to IVIG altogether. Here is a quote from a physician in New York the
sums up the flavor of our calls in 2005: ``I cancelled all of my
Medicare patients. The price of IVIG has increased and I can no longer
sustain the loss. I do not know what to do and I am in total despair.''
We received a call from a patient in Missouri, typical of many
others, who said: ``I am an 81 year old Medicare PID patient--I am sick
all the time, and am not sure if I will be able to live long enough to
get my next infusion. I had an infusion scheduled at the hospital. As I
was leaving for the hospital, they called to cancel my appointment.
They told me that they will not be able to infuse me. Can you help
It does not make sense to move a primary immune deficient patient
out of a closely monitored infusion suite, physician's office, or home
care environment--with nurses who are trained in the administration of
IVIG--to a hospital where an immune-compromised patient can be exposed
to an opportunistic infection. I cannot believe it was any
policymaker's intention to shift all patients to hospitals, which is,
in fact, the most expensive site of care.
IDF and other groups spent a great deal of time communicating to
Congress and CMS the devastating impact of Medicare Reimbursement
reductions on our community. IDF conducted a national survey of
Medicare patients, which provided quantitative data on the impact of
the reimbursement changes. 39% of these patients had problems because
of reimbursement, and 40% of these patients suffered negative health
outcomes as a result of reimbursement.
We begged that the reimbursement rates for the hospitals not be
reduced as dramatically as they had for the physician outpatient
However, on January 1, 2006, hospitals were also switched from the
AWP to the ASP formula. Even faster than expected, many outpatient
hospital clinics eliminated IVIG infusions to patients because it was
too costly to continue treating at the current reimbursement rates. CMS
did implement a temporary preadministration fee for the physician's
office and hospital, but it was not enough to offset the reduction in
reimbursement from the ASP formula and the reduced administration fees.
Patients in some states have been devastated. For example, the
state of Nebraska has only one hospital treating on an outpatient basis
with IVIG; the state of Florida has a handful of hospitals left, and in
the state of Texas, most Medicare patients in Dallas, Houston and
Irving cannot receive IVIG in a hospital. We have reports of patients
not receiving IVIG since last November. Without IVIG they will
eventually become disabled and die prematurely.
The impact of Medicare reimbursement does not stop with Medicare
patients. During the past year, we have heard of more private insurance
carriers reducing their reimbursement rates to those of Medicare--with
even children being denied therapy! Our patient community has always
dealt with an unusual burden of insurance problems because of the
nature of their chronic illness and the cost of the expensive
therapies--but the recent changes are unnecessarily devastating.
While the medical details are different, the medical outcome is the
same as taking chemotherapy away from a cancer patient or insulin away
from a from a diabetic. IVIG has been taken away from patients who will
die without it. Are these patients not important to our society?
I am going to share a story of a patient who was personally
affected by the changes to reimbursement after being denied access to
IVIG. Her name is Pam Way. I met Pam at the Department of Health and
Human Services Advisory Committee on Blood Safety and Availability
meeting last May 2005. Pam had Chronic Inflammatory Demyelinating
Polyneuropathy (CIDP) and Myositis, disorders for which IVIG is
recognized as medically indicated. When Pam was treated with IVIG, she
was walking and fairly healthy. But when the Medicare Modernization
bill was enacted, she was shifted from her doctor's office to the
hospital. At the hospital, she was unable to get the brand of IVIG that
she required. In addition, she could not receive her infusions on a
Patients with immune problems require brand-specific IVIG, because
each product is different. Patients treated with brands their bodies
don't tolerate can suffer life-threatening anaphylactic reactions. I
once saw my son collapse after receiving a new product. Product choice
for IVIG is critical for patients.
Congress understood this and exempted IVIG from the competitive
acquisition program. Although it was Congress' intent to ensure that
patients have access to all brands of IVIG, the opposite has occurred,
because the reimbursement rate for IVIG is too low.
Due to the changes in reimbursement, Pam stopped receiving her IVIG
infusions on a regular basis and her health deteriorated to the point
that she was becoming nonfunctioning. Eventually, it took all the
strength she had, when she appeared in a wheelchair to speak before the
Advisory Committee in May of 2005. She literally begged for her life.
The Committee recommended that the Secretary declare a public health
emergency. Pam was one of thousands of patients across the country that
was too sick to fight for themselves, but she tried.
Although the Committee tried to help, Secretary Leavitt did not
take action. Last year, a letter signed by 28 Members of Congress was
sent to Secretary Leavitt requesting that he declare a public health
emergency. Once again, nothing happened. A few weeks ago, 58 Members of
Congress sent a letter to Secretary Leavitt requesting that he declare
a public health emergency. I would like to thank Congressman McCrery
and Foley for their leadership on this effort, as well as the Members
of this Subcommittee who signed on to this letter, which include:
Congressman Camp, Congressman Ramstad, Congressman English and
In the meantime, the public health emergency has not been declared,
reimbursement remains inadequate and Pam never got the continuity of
treatment she needed. Pam was only able to receive IVIG when she was
admitted to the intensive care unit and it was too late. Pam died in
April of this year. And we will have more deaths while the government
continues to study the problems of the marketplace and supply.
When will someone say that the lives of these patients are
important? We continue to share stories of patients suffering, but no
one takes action to restore access to IVIG.
Even with the newest reimbursement rate increases effective July 1,
only one immune globulin brand will become affordable and available to
It is a national disgrace that this problem has persisted since
January 2005, and nothing has been done to help save these patients
lives. The long-term effects to patients who were already on disability
or elderly are immeasurable.
Chairwoman Johnson, how many more patients have to suffer, how many
more patients have to die to acknowledge the public health emergency
that has been allowed to continue since January 2005?
I implore of the Subcommittee today, to take emergency action to
restore access to IVIG.
Once again, thank you for including the IVIG patient community in
Chairman JOHNSON OF CONNECTICUT. Thank you, Ms. Boyle. Mr.
STATEMENT OF RICHARD FRIEDMAN, EXECUTIVE CHAIRMAN, BIOSCRIP,
ELMSFORD, NEW YORK
Ms. FRIEDMAN. Chairman Johnson, Representative Stark and
distinguished Members of the Subcommittee, I am Richard
Friedman, Chairman and CEO of BioScrip. Thank you for the
opportunity to testify today on the Medicare part B Competitive
Acquisition Program. As the sole vendor for this program, we
believe that BioScrip's testimony will provide the Subcommittee
with insight into the CAP program.
My testimony today will focus on CAP implementation and
structural barriers to physician election and proposed
solutions. BioScrip provides pharmaceutical care solutions with
a primary focus on specialty medication distribution and
clinical management services. Our specialty medication
distribution services include condition-specific clinical
management programs to improve the care of individuals with
complex health conditions such as HIV/AIDS, cancer, Hep-C,
rheumatoid arthritis, hemophilia, MS, transplantation or
conditions requiring immunosuppressive medications.
Through our National mail order facility and 31 community
pharmacies in 26 U.S. cities, BioScrip provides local specialty
pharmacy and infusion support to patients and prescribers. We
partner with healthcare payers, pharmaceutical manufacturers,
government agencies and physicians to manage patient outcomes
and control costs. Since the CAP began, BioScrip has shipped
354 drug orders to 41 physicians throughout the United States.
We have made a significant initial investment in new
infrastructure and physician education initiatives and have
been closely working with CMS. We have created a list of drug
assistance programs and foundations to support Medicare
beneficiaries who cannot afford the 20 percent copayment.
Since being announced as a sole CAP vendor, BioScrip has
been working hard to make sure the transition is smooth for
both physicians and beneficiaries. The July 1, 2006,
operational startup was successful. However, there are several
structural challenges that we believe is part of the reason for
which physicians have not enrolled. In March 2006, BioScrip,
along with other vendors, were offered the CAP contract.
BioScrip believed, based on our expertise in management and
distribution of specialty medications, the CAP program was a
good fit. BioScrip was already involved in similar programs in
the private sector.
BioScrip's bid was less than ASP plus 6 percent and a final
rate of ASP plus 4.4 percent was offered to BioScrip by CMS
based upon the competitive pricing process. To prepare for the
CAP implementation, BioScrip made significant investments. We
retained 90 new dedicated people in operations to support an
estimated 2,000 physician practices. We recovered accruement
fees for these hires. We utilized 55 sales professionals to
educate physicians across the United States. We developed
educational support, including print and media, and we invested
in facility upgrades.
We believe that many physicians still have unanswered
questions regarding the benefits of the CAP. Educational
outreach needs to continue by CMS, Noridian and BioScrip.
BioScrip has made physician education and outreach a priority
in its implementation strategy. To date, we have contacted 265
national, regional and State associations and related
organizations and 19,182 physicians. We have faxed 34,000
physician practices and e-mailed 25,000 physicians. We met with
45 pharmaceutical manufacturers, either in person or by phone,
and established a toll-free BioScrip CAP information specialist
call center. We developed a dedicated CAP page on BioScrip's
Web site. We hosted two audio conferences to present a program
to 400 physicians and we continue to provide ongoing physician
support for election and operational issues.
Chairman JOHNSON OF CONNECTICUT. Mr. Friedman, I neglected
to say your entire statement will be submitted for the record,
but the opening statements are 5 minutes. If you could kind of
move more rapidly through your last couple of pages.
Ms. FRIEDMAN. Sure. To go through what we believe are the
barriers and the solutions for them, first is a lack of on-site
inventory. The physician orders for CAP drugs are patient-
specific and have to be made in advance. Physicians complain
that this system allows for limited flexibility to adjust
treatment to shifting disease states or accommodate
unanticipated therapeutic needs. Our solution is to supply
physicians' offices with limited inventory to meet emergency
The second barrier is the requirement to ship to the site
of drug administration. Our solution is to permit shipments to
multiple locations designated by the physician.
The third barrier is the added billing requirements for the
physician. Our solution is to simplify the physician billing
practice. Physicians would bill for the administrative fee only
and not have to change their billing systems, and we could
monitor that program.
The fourth barrier is the physician concern over co-pay.
Our solution is to give physicians the option to support the
copay for non-paying beneficiaries on a patient-specific basis.
Finally, the last barrier is physician education as to the
benefit of the CAP program within the limited election period.
Our solution is to continue the education and allow for an open
enrollment period for physicians.
In closing, BioScrip would like to once again thank the
Subcommittee for this opportunity to testify. We have made a
significant financial investment to ensure the success of this
program. Based upon the small number of physicians that have
initially enrolled, we will not recognize a return on our
investment. We firmly believe that CAP can be a successful
long-term program, as proven in the private sector. I believe
that in coordination with CMS and Congress, we can make this a
reality. Thank you for your time.
[The prepared statement of Mr. Friedman follows:]
Statement of Richard Friedman, Executive Chairman, Bioscrip,
Elmsford, New York
Chairman Johnson, Representative Stark, distinguished members of
the Subcommittee, I am Richard Friedman, CEO of BioSCrip, Inc. and my
esteemed colleague to my right is Russ Corvese, BioScrip's Senior Vice
President of Operations. We would like to thank you for the opportunity
to testify today on the Medicare Part B Competitive Acquisition Program
(CAP). As the sole vendor for this program that was launched just 13
days ago, BioScrip's testimony will provide the subcommittee with
insight into the CAP program and some of our early successes and
My testimony today will focus on four topics:
Benefits of the CAP for Medicare beneficiaries and
CAP implementation dates and entities involved
CAP structural barriers to physician election and
solutions to improve the CAP
Financial implications to the vendor
BioScrip, Inc. provides pharmaceutical care solutions with a
primary focus on specialty medication distribution and clinical
management services, and pharmacy benefit management services. Its
specialty medication distribution services include condition-specific
clinical management programs to improve the care of individuals with
complex health conditions, such as HIV/AIDS, cancer, hepatitis C,
rheumatoid arthritis, hemophilia, multiple sclerosis, and
transplantation, or conditions requiring immunosuppressive medications.
Through 31 community pharmacies in 26 U.S. cities, BioScrip provides
local specialty pharmacy and infusion support to patients and
prescribers. It partners with healthcare payors, pharmaceutical
manufacturers, government agencies, and physicians to manage and
We appreciate this opportunity to testify on the Medicare Part B
CAP and its role in providing savings for the Medicare program and
beneficiaries, while maintaining access and easing the burden on
physicians. We applaud Congress for authorizing this important new
program as part of the Medicare Modernization Act of 2003 (MMA). In
less than two weeks since the CAP began, BioScrip has already shipped
113 drug orders to 26 physicians. We made a significant initial
investment in new infrastructure and physician education initiatives
and have been closely working with the Centers for Medicare and
Medicaid Services (CMS) and the designated CAP carrier, Noridian, to
resolve any technical issues that impact the CAP. We have created a
list of drug assistance programs and foundations to support Medicare
beneficiaries who cannot afford the 20% co-payment. Since announced as
the sole CAP vendor, BioScrip has been working hard to make sure the
transition is smooth for both physicians and beneficiaries. We believe
that the July 1, 2006 operational start up was successful; however,
there are several structural challenges that will need to be addressed
before developing the CAP into a real alternative to the ``buy and
bill'' system, as provided by the statute.
II. BENEFITS OF THE CAP
The MMA established a new methodology for Medicare Part B
reimbursement of most covered drugs. Effective January 1, 2005,
reimbursement to physician practices for drugs was changed from 95% of
the average wholesale price (AWP) to 106 percent of the average sales
price (ASP). The MMA also mandated the implementation in 2006 of a
competitive acquisition program (CAP) for part B drugs and biologicals,
as a second step in reducing Medicare overpayments. The program would
represent an alternative to the ``buy and bill'' system for acquisition
of drugs administered in physician offices. More specifically, the CAP
has the potential to:
Eliminate manufacturer incentives that increase the
spread between Medicare payments and the physician purchase price
Eliminate overspending Medicare's limited resources
Reduce costs for Medicare beneficiaries who are
responsible for a 20% copayment of the total cost
Reduce time and resources utilized by physician practices
for drug acquisition
Reduce physicians' administrative costs and financial
liability by moving the responsibility to collect beneficiary
deductibles and coinsurance from the physician practice to the CAP
III. CAP IMPLEMENTATION
CMS published the CAP proposed rule in March 2005, followed by the
interim final rule on July 6, 2006. The initial vendor bidding process
was cancelled before the scheduled deadline (August 5, 2005) and the
program start was delayed. On November 21, 2005 CMS published some
final CAP provisions as part of the final rule on the 2006 physician
fee schedule. The CAP vendor bidding process closed on December 22,
2005. In late March 2006, CMS offered CAP contracts to five vendors. On
April 21, 2006, CMS officially announced BioScrip as the sole CAP
vendor. The initial physician election period was scheduled for May 8--
June 2, 2006 and subsequently extended through June 30, 2006. BioScrip
started shipping CAP orders on June 28, 2006, for a July 1, 2006
program start date.
The CAP reimbursement rate of 104.4% of average sales price (ASP)
was driven by competition among the five bidders who were offered CAP
contracts. However, BioScrip, the only CAP vendor, bore the entire
burden of program implementation and the lion share of physician
education and outreach.
Based upon estimates of 2,000 physicians electing to participate in
the CAP, we made a significant initial investment in new infrastructure
and physician education initiatives and have been closely working with
CMS and Noridian to resolve technical and operational issues. BioScrip
has created a list of drug assistance programs and foundations to
support Medicare beneficiaries who cannot afford the Medicare part B
cost-sharing (deductible and 20% co-payment). Since announced as the
sole CAP vendor, BioScrip has been working hard to make sure the
transition is smooth and does not affect beneficiaries' access to
To prepare for the CAP, BioScrip has invested significantly in
infrastructure and human resources:
Retained up to 90 dedicated people in operations to
support an estimated 2,000 physician practices
Incurred recruitment fee for 90 individuals
Invested in technology
Initiated sales initiatives across the U.S. utilizing 55
Developed marketing support including print and media
Invested in facility upgrades (Columbus facility solely
for the CAP)
Expended executive time and travel to organize and
BioScrip understands that, given the short time frame allowed for
physician CAP election, it is essential that physicians are properly
educated and informed about the program before they decide if the
program addresses their needs. The initial physician election period
was restricted to 26 days, and then extended through the month of June,
2006. BioScrip believes that many physicians and practices still have
unanswered questions regarding the benefits of the CAP. Despite the
regulatory mandate, the Medicare part B local carriers have been
involved in minimal CAP educational activities. The outreach efforts of
CMS and Noridian, we believe, need to significantly continue. BioScrip
has made physician education and outreach a priority of its
Physician education activities have been a priority for BioScrip and
Outreached and/or presented to 265 national, regional,
state associations, professional societies and related organizations
Outreached to 19,182 physicians via phone and/or in-
Faxed 34,000 physician practices
E-mailed 25,000 physicians
Met with 45 pharmaceutical manufacturers either in person
or by phone
Received over 2,000 Web Hits to BioScrip CAP web page
Established toll-free BioScrip CAP Information Specialist
Developed technical language on dedicated page on
BioScrips web site
Trained entire sales force/representatives regarding CAP
and the benefits to physicians
Created multiple educational materials utilized in
initial CAP launch and physician outreach education
Purchased physician list of approximately 40,000 names
Provided ongoing physician support for election and
Hosted two audio conferences to present the program to
400 physicians, to educate on the operational process and answer
Based on the actual physician election numbers received from CMS
and Noridian, the physician participation levels came significantly
below the expected program target of 1,500 to 2,000 physicians.
BioScrip prepared for 2,000 physicians submitting orders on July 1,
2006. To date, we have a total of 307 CAP physicians, with 664 practice
locations. A breakdown of election numbers by specialty is provided in
Appendix B. Physician specialties with the highest Medicare part B
allowed charges--see Appendix B--are the least represented among this
group. Physicians who joined the CAP repeatedly specified that they
wanted to leave the ``buy and bill'' system and are happy with the
reduced administrative burden.
IV. CAP STRUCTURAL BARRIERS
BioScrip appreciates that physician CAP election is essential to
make CAP a viable alternative to the current ``buy and bill'' system,
achieve savings for the Medicare program and beneficiaries. From
discussions with physicians who would consider CAP but have not yet
elected to participate, BioScrip has found that there are still
structural barriers that affect physicians' decision to sign up for the
CAP. Among the most frequently cited barriers are:
A) Lack of On-Site Inventory
Unlike the ``buy and bill'' system, physician orders for CAP drugs
are patient-specific and have to be made in advance. Many physicians
complain that this system allows for limited flexibility to adjust
treatment to shifting disease states or accommodate unanticipated
SOLUTION: Supply physicians' offices with limited inventory to meet
Having an adequate drug inventory stocked in physician offices will
provide needed flexibility and increase beneficiary access to the
drugs. BioScrip is already using ``loaned inventory'' practices for its
commercial side of the business, and could logistically accommodate
this request. Drug orders will still be submitted for each patient, but
the physician will use existing CAP drug stock for administration.
BioScrip will follow-up and replace the drugs used.
However, from a cash-flow perspective, BioScrip cannot afford to
maintain this inventory in physicians' offices and wait to be
reimbursed after the administration of the drug. One option to address
this issue would be a pre-payment or advanced payment from Medicare
that will then be periodically reconciled against submitted claims.
This option would be budget-neutral. Other options include the creation
of a supply fee that would allow BioScrip to accumulate the necessary
capital to support this ``loaned'' inventory.
B) Requirement to Ship to Location
The CAP vendor has a regulatory obligation to ship any CAP drug to
the location where the drug is administered to the patient. Many
physician practices have satellite locations opened only one or two
days each week, to serve patients in rural or remote areas. These
practices have expressed concern that shipping drugs to those locations
will require additional resources and coordination to receive drugs and
maintain inventory at multiple locations. Moreover, BioScrip has heard
from physicians who have already enrolled in the CAP but did not
realize they had to sign up for all locations.
From the vendor's perspective, shipping to multiple locations and
the need for additional coordination will increase costs. In addition,
by having to ship and store multiple-use vials to more locations, the
potential for drug waste--and BioScrip's financial liability--will
SOLUTION: Drug-shipping to location selected by physician
To implement the CAP as an equivalent alternative to the current
``buy and bill'' system and ensure adequate and timely access to the
drugs for Medicare beneficiaries, a similar process should be adopted
to deal with physician practices with multiple locations. Thus, drugs
would be shipped to the location chosen by the physician, including the
practice central office, and then transported and prepared at the
location of administration by the physician or other authorized health
C) Burdensome Claims Processing
Physicians are required to bill for the administration fee within
14 days from the drug administration date. The claim would include, in
addition to information about physician services provided, detailed
information about the drugs administered (including unique identifiers,
J-code and NCD code, and dosage) identical to the information submitted
by the vendor in the parallel claim for the drug. Physicians are
complaining that this process is increasing rather than reducing
paperwork and that there is not sufficient time for physician offices
to change their billing systems to accommodate the new requirements
before the program start-up.
SOLUTION: Simplifying physician billing process
One of the stated goals of the CAP is the potential to reduce
physician practice administrative workload and associated costs. While
we understand the need to implement upfront checks to allow CMS to
match drug and physician service claims and eliminate fraud and abuse,
this complex new process represents a significant burden for physicians
and a barrier to enrollment in the CAP. Physicians would prefer to
continue billing for the administration fee only and not have to change
their billing systems to incorporate new information such as the unique
identifier. CMS could continue to use audit and compliance programs
implemented under ``buy and bill'' to ensure accuracy of claims and
payments to both physicians and the CAP vendor.
D) Beneficiary Co-Pay Collection
Medicare beneficiaries are, in general, responsible for 20% co-pay
on part B drugs and biologicals. Under the CAP, responsibility for
collecting co-pays will shift from physician practices to the CAP
vendor, BioScrip. The CAP reimbursement rate set through competitive
bidding results in a net CAP profit estimated at 1% or less. Thus,
BioScrip will depend on co-pay collection to make sure it can continue
as a CAP vendor. At the same time, physicians are worried that patients
who cannot pay the 20% co-pay will be cut-off from the drug supply.
BioScrip has been partnering with associations, foundations, and
drug manufacturers to find solutions to help beneficiaries who cannot
afford the co-pays. However, many physician practices are still
concerned they will lose patients who are not eligible for these
SOLUTION: Physician option to offer cost-sharing support for co-pay for
Under the ``buy and bill'' system, many physician practices provide
financial support for some of the beneficiary cost-sharing (co-pays and
deductible), particularly for low-income beneficiaries. Under the CAP,
beneficiaries will have expanded access to prescription assistance
programs, but would no longer benefit from this support offered by
their physicians. If co-pays remain unpaid despite access to assistance
programs and attempts to schedule a payment plan with the beneficiary,
the CAP vendor is allowed to stop providing CAP drugs for that
particular beneficiary. Some physicians are worried about these
situations and would like to see more flexibility in the co-pay
collection process, such as an option given to the physician to offer
cost-sharing support for these non-paying beneficiaries, similarly to
the current practice.
E) Limited Physician Election Period
The initial CAP enrollment period began May 8, 2006, two weeks
after the CAP vendor was announced and 3 days before the first CMS
conference call aimed at educating physicians about the new program.
The first announcement about the CAP enrollment was sent to CMS
physician listserv subscribers and posted on the CMS website on May 5,
2006. CMS extended the initial election period until June 30, 2006, to
allow more physicians to learn about the CAP and decide if they want to
BioScrip has made a significant upfront investment to prepare for
the CAP implementation, particularly for education and outreach to
physicians and physicians' practices. BioScrip found that one-on-one
encounters were the most effective in educating physicians and
physician groups about program operations and benefits. Since the
potential pool of CAP physicians is about 40,000, these education and
outreach efforts will take time and go beyond the extended enrollment
deadline of June 30, 2006. At the same time, many physicians would
apparently wait to see how the CAP works in the first month or so
before making a decision about enrollment. The limited enrollment
period will not allow these groups to participate in the CAP before
January 1, 2007.
SOLUTION: Maintain open-enrollment period for physicians
There is no ?hard' deadline in the statute that would limit the
physician enrollment period. Adoption of an open enrollment period, at
least for this first year of CAP implementation, would allow more
physicians to sign up for the program and more time for education and
V. FINANCIAL IMPLICATIONS TO THE VENDOR
BioScrip has invested significant financial resources to ensure the
success of this program. Based upon the number of the physicians that
have initially enrolled in the program, BioScrip--or any vendor--cannot
keep investing in the CAP where it will not recognize the return on
investment. To continue these efforts, particularly physician education
and outreach, BioScrip needs congressional support to remove barriers
to physician election and ensure that the CAP is viable.
In closing--BioScrip would like to once again thank the
Subcommittee for this opportunity to testify on the newly implemented
CAP program. We share the subcommittee's desire to eliminate excess
cost and waste from Medicare and we strongly support the CAP, which we
believe is a viable program that has the potential to save money while
maintaining quality of care and beneficiary access to life-saving
prescription drugs. Although I indicated a number of concerns and
structural barriers to the CAP program--I believe that in coordination
with CMS and the U.S. Congress--these current barriers can be
immediately addressed and resolved. We are very committed to continue
working with this committee, CMS, and all other germane partners to
implement a viable CAP.
If you have questions concerning BioScrip's written or verbal
testimony, please do not hesitate to contact me or my Washington
Legislative Counsel, the Dumbarton Group, for additional assistance.
Appendix a--Important CAP dates
December 2003--The Medicare Modernization Act (MMA) is
passed; Provisions referring to the implementation of the CAP for the
acquisition of part B drugs and biologicals are included in section 303
March 4, 2005--CMS releases the CAP proposed rule
July 6, 2005--CMS releases the CAP interim final rule
August 2005--Initial CAP bidding process cancelled
September 6, 2005--CMS releases technical updates to the
CAP interim final rule that changes the CAP implementation dates
November 21, 2005--CMS releases some final CAP provisions
as part of the 2006 physician fee schedule
November 15--December 22, 2005--CMS accepts vendor bids
for the CAP program
March 31, 2006--BioScrip receives CAP award letter from
April 7, 2006--BioScrip signs the offered contract
April 18, 2006--BioScrip is informed of sole vendor
April 19-20, 2006--BioScrip meets with CMS and Noridian
April 24, 2006--BioScrip establishes a CAP help desk
April 28, 2006--BioScrip starts creating CAP educational
May 4, 2006--BioScrip starts making capital investments
to prepare for the CAP
May 5, 2006--Physician election period is announced on
CMS physician listserv
May 8, 2008--Initial physician CAP election period starts
May 11, 2006--First CMS call on CAP for physicians
May 31, 2006--First BioScrip call on CAP for physicians
Early June--BioScrip starts one-on-one physician outreach
June 1, 2006--The new 90 BioScrip employees for the CAP
June 2, 2006--Initial CAP physician election period ends;
extended election period is announced
June 2, 2006--BioScrip meets with CMS to discuss CAP
structural and operational issues
June 19, 2006--Second CMS call on CAP for physicians
June 22, 2006--Second BioScrip call on CAP for physicians
June 22, 2006--BioScrip receives the first physician
election file (partial data)
June 23, 2006--BioScrip starts making welcome calls to
physicians (ongoing process)
June 28, 2006--BioScrip starts shipping product to
June 29, 2006--BioScrip receives the second physician
June 30, 2006--Extended physician election period ends
Appendix B--Number of CAP physician elections
Specialty Number of CAP physicians
Clinic or group practice 1
Critical care 5
Family practice 1
Infectious disease 4
Maxillofacial surgery 2
Medical Oncology 18
Neurological surgery 19
Orthopedic surgery 6
Plastic surgery 1
Source: BioScrip physician election data, valid as of July 10, 2006.
Medicare part B allowed charges for part B drugs and biologicals
administered in physicians' offices, 2003
Specialty group Number of claims Allowed charges
Oncology 7,311,248 $5,647,268,606
Ophthalmology 169,061 154,720,837
Psychiatry 43,752 3,626,108
Rheumatology 952,381 404,027,916
All other specialties 12,034,708 1,369,525,241
Source: CMS claims data, 2003. CAP Interim final rule, July 6, 2005.
Chairman JOHNSON OF CONNECTICUT. Thank you very much. Dr.
STATEMENT OF JORDAN S. ORANGE, M.D., PH.D., CHAIR, PRIMARY
IMMUNODEFICIENCY DISEASE COMMITTEE, AMERICAN ACADEMY OF
ALLERGY, ASTHMA AND IMMUNOLOGY, ASSISTANT PROFESSOR OF
PEDIATRICS, UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE,
Dr. ORANGE. Chairwoman Johnson and Members of the
Subcommittee, I thank you for inviting me to testify as a
practicing immunologist with expertise in the safe and
effective administration of intravenous immunoglobulin, or
IVIG. I am also currently the Chairman of the Primary
Immunodeficiency Committee of the American Academy of Allergy,
Asthma and Immunology, or quad A-I. The quad A-I is our
country's largest professional organization for allergists and
immunologists, with over 6,000 members. My clinical practice is
limited to patients with primary immunodeficiency diseases, or
PIDs result from inherent defects in a patient's immune
defense, leaving gaping holes that make the patient susceptible
to recurrent, severe and unusual infections. Some of these are
life threatening and others result in chronic deterioration of
organ function, leading to disability and premature death.
Fortunately, treatments have been developed for some PIDs, the
crown jewel of which is IVIG. IVIG contains antibodies obtained
from the plasma of thousands of volunteers to assure a broad
array of protection for patients who have an inability to make
useful antibodies of their own. The ability to safely and
effectively provide IVIG to PID patients is essential for their
survival and well-being.
Immunologists across our country are deeply concerned that
current reimbursement processes are endangering our patients. A
recent membership-wide survey of the quad A-I ascertained that
95 percent of respondents feel current reimbursement standards
present risk to the health of patients with PIDs. As a result,
the quad A-I has been firmly committed to understanding the
issues underlying the current IVIG debate and working to
provide physicians the necessary resources to ensure safe and
effective therapy for their patients. As an example, this
manuscript published in the Journal of Allergy and Clinical
Immunology entitled ``Use of IVIG in Human Disease, a Review of
Evidence By Members of the PID Committee of Quad A-I.'' Herein,
we review the clinical evidence underlying the six FDA approved
indications and nearly 100 off-label uses of IVIG. Some are
supported by clinical evidence of the highest order, while
others are only anecdotally supported or not supported at all.
This document, however, is only a review of evidence and
does not represent a prioritization of indications based upon
medical necessity or lack of alternative therapies. To contend
with these issues, my hospital convenes all specialties
prescribing IVIG to prioritize usage based upon our inventory.
We have over 30 indications for which we allow IVIG treatment
and divide these into four categories of priority. These are
based upon a combination of the clinical evidence underlying
the indication, the therapeutic alternatives for that
particular diagnosis and the seriousness and severity of the
condition. I believe this type of assessment is essential to
ensure that patients who most desperately require IVIG will
Our published evidence review also does not comprehensively
address the utilization of IVIG within specific indications.
This issue requires careful consideration to prevent waste and
will benefit from the development of indication-specific
guidelines. The quad A-I has been addressing this from a PID
standpoint. The quad A-I has also generated a site of care
guideline. This effort reflects the complexity of administering
IVIG to PID patients, which is a feature of it being a
biological response modifier, or BRM. A BRM is defined by the
National Library of Medicine as ``a treatment intended to
stimulate or restore the ability of the immune system to fight
infection and disease.'' This is exactly what IVIG does for PID
As currently the administration of IVIG is viewed as low
complexity and is reimbursed using non-chemotherapy
administration codes, as is saline and antibiotics, we fear
that reformulated reimbursements will no longer support the
safest and thus the most effective administration of IVIG to
patients. Finally, as clinical research uncovers new uses for
IVIG, it appears that utilization is on the rise. Thus, it is
critical to continually reevaluate the appropriate use of and
indications for IVIG to ensure that patients who will benefit
the most from therapy and have the least therapeutic
alternatives will have access. I speak for the quad A-I to say
that as academic immunologists, we are grateful for the
invitation to be heard today and for our opportunities to work
with HHS. We look forward to working with your Committee and
with HHS in the future to benefit the patients whose lives
depend upon IVIG therapy. Thank you.
[The prepared statement of Dr. Orange follows:]
Statement of Jordan S. Orange, M.D., Ph.D., Chair, Primary
Immunodeficiency Disease Committee, American Academy of Allergy, Asthma
and Immunology, Philadelphia, Pennsylvania
Chairwoman Johnson and Members of the Subcommittee, I thank you for
inviting me to testify as an academic clinical immunologist with
expertise in the safe and effective administration of intravenous
immunoglobulin (IVIG). I am a practicing physician scientist at the
Children's Hospital of Philadelphia with an appointment as Assistant
Professor of Pediatrics at The University of Pennsylvania School of
I am also currently the chairman of the Primary Immunodeficiency
Committee of the American Academy of Allergy, Asthma and Immunology or
AAAAI (``quad A-I''). The AAAAI is our country's largest professional
organization for allergists and immunologists certified by the American
Board of Allergy and Immunology, a sub-board of the American Board of
Medical Specialties. The AAAAI has more than 6,000 members and has the
goals of educating its members and the public to ensure the provision
of safe and effective care to patients affected by allergic and
My clinical practice is limited to patients with disorders of
immunity and specifically those with primary immunodeficiency
disorders. These diseases result from inherent defects in a patient's
immune defenses resulting in gaping holes that leave a patient
susceptible to recurrent, severe, and unusual infections. Some of these
infections are life threatening in and of themselves and others result
in chronic deterioration of organ function leading to disability and
premature death. Fortunately, medical science has developed treatments
for some of the primary immunodeficiency diseases, the crown jewel of
which is IVIG. The criteria for primary immunodeficiency diseases (PID)
diagnoses as well as the evidence underlying treatment with IVIG have
been recently published in the Annals of Allergy, Asthma and Immunology
as the Practice Parameter of the Diagnosis and Management of Primary
Immunodeficiency, on which I am an author.
IVIG are antibodies purified from the plasma of thousands of U.S.
volunteers. I describe antibodies to my patients as unique ``sponges''
that float around in the bloodstream having the ability to ``soak up''
different types of infections. The large number of plasma donors is
necessary to insure a broad array of antibody specificity for patients
who have an inability to make specific antibodies of their own.
The ability to safely and effectively provide IVIG to patients with
primary immunodeficiency is essential for their survival and well-
being. Immunologists across our country are deeply concerned that
current reimbursement processes are endangering our patients. In fact a
recent membership-wide survey of the AAAAI (completed March 2006) has
ascertained that 95% of the more than400 respondents feel current
reimbursement standards present at least some risk to the health of
patients with primary immunodeficiency diseases and more than half
estimate this risk as serious or extreme.
Building upon these concerns, the AAAAI has been firmly committed
to understanding the issues underlying the current IVIG debate and
working to provide prescribing physicians the necessary resources to
ensure safe and effective therapy for their patients. I would like to
highlight several of these efforts for you.
The first is a manuscript published as a supplement to the April
2006 issue of the Journal of Allergy and Clinical Immunology entitled:
``Use of intravenous immunoglobulin in human disease: A review of
evidence by members of the primary immunodeficiency committee of the
AAAAI.'' This document, of which I am the lead author, reviews the
clinical evidence underlying the six FDA approved indications and
nearly 100 off-label uses of IVIG. These indications range from
extremely rare conditions to those that are relatively common. Some
indications are supported by clinical evidence of the highest order,
while others are only anecdotally supported, or are not supported at
all. This document, however, is only a review of published research and
expert opinion. It does not represent a prioritization of indications
based upon medical necessity or lack of alternative therapies. For
example, toxic epidermal necrolysis is a very rare disease that is
nearly uniformly fatal without IVIG therapy. As a result, high-quality,
placebo-controlled trials of IVIG in this disease will never be
possible. For these reasons these diseases will never be able to attain
the highest strength of recommendation, but the utility of IVIG is the
standard of care.
To contend with these issues my hospital regularly convenes all
medical services prescribing IVIG to prioritize our usage based upon
our inventory. We have approximately 30 indications for which we will
allow IVIG treatment and have divided these into 4 categories of
priority. The prioritization is based upon a combination of: the
clinical evidence underlying the indication; the therapeutic
alternatives available for use in that particular diagnosis; and the
seriousness and severity of the condition. I believe this type of
assessment is essential to ensure that patients who most desperately
require IVIG will receive it.
Our published evidence review also does not comprehensively address
the utilization of IVIG within specific indications. This issue
requires careful consideration to prevent waste and will benefit from
the development of indication-specific guidelines.
In this light the AAAAI has developed an IVIG ``tool kit'' to
address the specific use of IVIG in primary immunodeficiency. This
document includes eight guiding principles for IVIG use. They are
explained in the document in more detail, but are outlined here in
1) Indication--IVIG therapy is indicated as replacement therapy for
patients with PI characterized by absent or deficient antibody
production. This is an FDA-approved indication for IVIG, which all
currently available products are licensed. 2) Diagnoses--There are a
large number of PI diagnoses for which IVIG is indicated and
recommended. This includes some with normal or abnormal total levels of
IgG. 3) Frequency of IVIG treatment- IVIG is indicated as continuous
replacement therapy for primary immunodeficiency. Treatment should not
be interrupted once a diagnosis has been established. 4) Dose--IVIG is
indicated for patients with primary immunodeficiency at a starting dose
of 400-600mg/kg every 3-4 weeks. Less frequent treatment of use of
lower doses is not substantiated by clinical data. 5) IgG trough
levels--IgG trough levels can be useful in some diagnoses to guide care
but are NOT useful in many and should NOT be a consideration in access
to IVIG therapy. 6) Site of care--The decision to infuse IVIG in a
hospital, hospital outpatient, community office, or home based setting
must be based upon clinical characteristics. 7) Route--Route of
immunoglobulin administration must be based upon patient
characteristics. The majority of patients are appropriate for
intravenous and a subset for subcutaneous therapy. 8) Product--IVIG is
not a generic drug and IVIG products are not interchangeable. A
specific IVIG product needs to be matched to patient characteristics to
insure patient safety.
Also included in the AAAAI IVIG ``tool kit'' is the IVIG site of
care guideline. This document outlines certain criteria that should
justify a patient receiving IVIG in a particular site of care. It was
designed with primary immunodeficiency diagnoses in mind, but does
apply to certain other diagnoses for which IVIG is indicated.
Just as important, this effort also highlights the fact that
administering IVIG to patients with PI can be a complex process.
Certain patients require physician supervision during infusion and need
a sophisticated approach to their treatment. This is an essential
element of safe and effective clinical care and one that depends upon
substantial expertise. In part, this relates to the role that IVIG
serves as a biological response modifier (BRM). A BRM is defined by the
National Library of Medicine and National Cancer Institute as: ``a
treatment intended to stimulate or restore the ability of the immune
system to fight infection and disease.'' IVIG is a BRM for patients
with PI as it enhances the defective components of immunity to fight
and protect against infection and complications of infection. In PI,
and in other indications, IVIG also modifies aberrant immune response
to protect, maintain and restore normal physiology to prevent disease.
As is commonplace with BRM therapy, adverse events occur frequently,
and the risk of severe adverse events (AEs) is real. For example, the
FDA licensing studies of IVIG for patients with PI (for which all
currently available IVIG products are licensed), include an occurrence
of total AEs as high as in 72% of patients. There are also numerous
severe AEs many of which are acute and include thromboembolism,
hypotension, seizures, aseptic meningitis syndrome, anaphylaxis, acute
respiratory distress syndrome (ARDS), pulmonary edema, apnea and
transfusion associated lung injury (TRALI). All IVIG products also
include a black box warning regarding acute renal failure. The
incidence of moderate and severe AEs associated with IGIV infusions is
not infrequent and is documented for one recently licensed product as
34% and 8% respectively. If nothing more, this underlines the
complexity of PID patients specifically who are being treated with
A reimbursement-related fear is that the reformulated strategy may
no longer support the highest quality, safest and most effective
approach to patients who require IVIG. Currently, administration of
IVIG is viewed as low complexity and is reimbursed using non-
chemotherapy administrative codes. Given the aforementioned concerns,
and what we as experts define as the standard of care this policy will
fail to support proper practice. In fact it will not even meet nursing
labor expense in many centers. Properly categorizing IVIG, as a high
complexity administration and reimbursement using the chemotherapy
administration codes will represent a substantial step in the direction
of acceptable practice and patient safety. I hope the committee will
support the comprehensive understanding of the requirements for safe
and effective infusion to ensure the safety and well-being of our
Finally, as clinical research uncovers new uses for IVIG, it
appears that utilization is on the rise. For these reasons it is
critical to continually reevaluate the appropriate use of, and
indications for IVIG to ensure that patients who will benefit the most
from IVIG therapy and have the least therapeutic alternatives will have
access. Thus, judicious use must be promoted and practiced now and in
I know I can speak for the AAAAI that as academic physicians we are
grateful for the invitation to be heard today and for our opportunities
to have worked with HHS. We look forward to working with your committee
and with HHS in the future to benefit the patients whose lives depend
upon IVIG therapy.
Chairman JOHNSON OF CONNECTICUT. Thank you. Dr. Orange, to
what extent does the problem reflect the expanded application
of IVIG to other situations, to other medical problems?
Dr. ORANGE. Well, it is actually hard to estimate to what
extent that reflects the problem, because we actually don't
know how the usage of IVIG is divided in this country. There
really hasn't been an effective survey of indications and
numbers vary widely. However, it is certainly very clear from
the patient organizations that uses in indications that are not
FDA approved are definitely increasing. Given how labor
intensive the production of IVIG is, it is a catchup process.
So, I think this does factor into it.
Chairman JOHNSON OF CONNECTICUT. We don't track the off-
label uses and whether they are effective or not?
Dr. ORANGE. We certainly track--there certainly is
published research whether or not the off-label uses are
effective. Some of them are extraordinarily effective, as
proven by meta-analysis data, the highest level of medical
evidence. What we don't know is how much of the total IVIG pool
goes to these different indications. That is not in the public
Chairman JOHNSON OF CONNECTICUT. You say it is a labor
intensive production drug. Do you think the supply is the
Dr. ORANGE. I think I would refer back to Mr. Kuhn's
comments, which I think are very well placed, which is it is a
very delicate balance--the production of the product and the
distribution of the product. Once again, it is difficult to say
where the problem lies, but there certainly are patients not
receiving immunoglobulin who need it.
Chairman JOHNSON OF CONNECTICUT. I must say, this
Subcommittee has had repeated briefings on this situation over
the years. I have never faced anything quite so frustrating.
Ms. Boyle, it is terribly disappointing to hear that people
have really died because our reimbursement structure seems to
be failing. On the other hand, we haven't been able to really
identify what is the supply problem, what is the payment
problem and what is the role of these off-label uses. So, we do
have some very good work going on now, and I hope we will be
able to move forward. We have a lot of interest on the
Committee. So, we will press hard. I don't want you to think we
haven't been paying attention for a year. It has been very
frustrating. Your testimony has been very helpful.
Dr. Schnell and Dr. Bailes, Dr. Bailes, your organizations
have about one-third of its members community oncologists. A
lot of its members are academic oncologists and have a
different perspective and a little different access. Do you see
a difference between your community oncologist members' access
to drugs at a price that they can afford that is under the
Dr. BAILES. Maybe I don't understand your question, Madam
Chairman. You mean as far as the size of the practice, or the
price of the drug? In my analysis of the OIG's report, at least
half of the drugs they reviewed, there were at least 20 percent
of physicians could not obtain them at the Medicare payment
rate. We hear that repeatedly.
Chairman JOHNSON OF CONNECTICUT. What I am asking you,
since your organization includes a membership that is broader
in scope, are you hearing from your community practice
physicians a different concern, a greater concern, a more
urgent and dire need than from your institutional providers?
Dr. BAILES. I would say that is correct, but we also hear
from institutional providers, too. Not to the extent we hear
from community providers.
Chairman JOHNSON OF CONNECTICUT. Dr. Schnell, you mentioned
you have heard from community providers that they are actually
closing satellite offices, shifting care of some patients that
don't have coverage to the hospital. Some, I understand, are
considering no longer caring for Medicare patients. Is this
information that you are receiving from your members pre-
January of this year, post-January of this year, in the last 3
months, as people have sort of looked at the system as it is
developing? What are you giving us, anecdotal evidence that is
just coming up now?
Dr. SCHNELL. Madam Chairman, we began tracking this as a
grassroots organization around the first of the year, so the
majority of the anecdotes and stories and quotes that we have
received and reports of these activities have been in 2006. I
would contend and submit to you that the majority of the
problems are because of the financial aspects of care that are
ambient in 2006 and were actually not present last year. We
lost, in terms of the outpatient treatment clinic income, we
lost the entire demonstration project at the end of last year,
plus we lost the 3 percent transition fee that has been already
reported upon by Members of your Committee, plus factually we
are seeing reductions, as you alluded to earlier, in services
in aggregate because of the lack of these replacement codes we
had anticipated for the last 28 months.
Chairman JOHNSON OF CONNECTICUT. How do you respond to
CMS's comment that they used your survey data and your survey
data included the cost of pharmacy?
Dr. SCHNELL. We have sent them our data approximately 3
months ago and have had no response. I gather that is not an
isolated experience, after sitting through this.
Chairman JOHNSON OF CONNECTICUT. It is true that they used
your data, and this was earlier on in the first round. It is
separate from the coding process. We do need to know the extent
to which that data did reflect pharmacy costs in the local
Dr. SCHNELL. Pharmacy cost data estimates come from an
analysis of practices that we did internally, but they fit very
nicely with what was reported in a recent immediate PAC study
that is in their written testimony that estimates that to be 26
to 28 percent in the State of Maryland.
Chairman JOHNSON OF CONNECTICUT. Mr. McCrery.
Mr. MCCRERY. Dr. Orange, before I get to you, Ms. Boyle, I
want to say thank you for the work you do on behalf of
immunodeficient patients. Your organization has certainly been
at the forefront of bringing attention to this whole issue,
and, were it not for your efforts, I suspect we wouldn't be
nearly as far along as we are in addressing the problem. So,
Ms. BOYLE. Thank you.
Mr. MCCRERY. Dr. Orange, you seem to me to be particularly
well situated to provide some insight into this problem, and
yet your testimony is not very clear. You say, for example,
that you prioritize; you meet, your staff meets, and you
prioritize patients, I assume you are talking about from
neediest to least neediest, and you start at the top I guess
with your supply, and you give that to number one and number
two until you run out. Is that basically what you do?
Dr. ORANGE. It is a matter of prioritizing diagnoses, but,
Mr. MCCRERY. Why do you run out?
Dr. ORANGE. Fortunately, we have not. I think that that is
due to some particularly--first, we are a large institution.
This is referring to my hospital. We have a good supply of
immunoglobulin, but we have actually had to suffer some of the
consequences of the current environment and we have had to
actually change--my hospital purchases one product to try to
make ends meet. We have exceptions for patients who need other
products. We purchase one product in the majority, and we have
had to change our product that we use twice in the past 12
months, which requires increased precautions. As one of the
immune deficient foundation surveys show, 34 percent of the
adverse reactions that occur during IVIG administration, occur
during a product change. We have had to go through this process
with all of our IVIG patients twice in the last year.
Mr. MCCRERY. Why have you changed products?
Dr. ORANGE. We don't buy IVIG through a purchasing
organization, we buy from a distributor. I cannot speak for our
pharmacy department here--I am not involved with this, but the
distributor has informed the pharmacy department that an
adequate supply of the product we are purchasing will not be
available. So, to make sure we will at least have----
Mr. MCCRERY. You just buy another kind?
Dr. ORANGE. Yes.
Mr. MCCRERY. Well, have you pressed your pharmacy
department to press your distributor for reasons why the kind
that you like is not available?
Dr. ORANGE. I certainly don't know about it. I think in
some ways we are happy to have IVIG.
Mr. MCCRERY. That would be helpful to this Committee, and
you seem, again, particularly well situated to do that. Surely
you have some relationship with your distributor, your pharmacy
department has some relationship with your distributor. They
spend a lot of money with them. So, use the marketplace to
demand an answer. Why can't you--what is the reason that you
can't supply what we prefer for our patients? See what they
say. It would be nice if you could let us know, or let CMS
know. Which gets me to my next question. Are you hopeful, let
me rephrase that, of course you are hopeful. Do you believe
that the two studies going on, one from the Office of Inspector
General and the other from the Assistant Secretary for Planning
and Evaluation of HHS, will bear fruit in terms of identifying
the reasons for at least anecdotally spot shortages or
shortages of one particular kind or another in the market and
problems with reimbursement levels?
Dr. ORANGE. I was very enthused by some of the studies that
are ongoing and particularly look forward to the results of Mr.
Mr. MCCRERY. Have you been contacted by either HHS or the
Office of Inspector General? Would you like to be?
Dr. ORANGE. I think a dialog, ongoing dialog is essential.
We have met with Mr. Kuhn before. I wasn't aware of his study
per se, but I am thrilled to hear about it. With what he
proposed, the one concern I do have is that we are not going to
identify the specific administration costs of safely and
effectively giving IVIG through that study; although it will
give incredibly valuable information. Once again, for a variety
of reasons, IVIG is reimbursed as a low complexity
administration. With the reformulation of reimbursement you
have to pay attention to how the different services are
Mr. MCCRERY. In your view, would that be a good solution to
the reimbursement problem, to separate the cost of the drug
from the complexity or time involved in administering the drug?
In other words, do you have a separate payment to the provider
for administering the drug?
Dr. ORANGE. There already is an administration code that
does support the provision of IVIG. It is just the way it has
been classified as a non-chemotherapy administration, I fear
that with everything being itemized at this point, that doesn't
support the safe and effective administration. We at the quad
A-I are working together with the Immune Deficiency Foundation
to try to ascertain some hard objective data, but don't have
that right now.
Mr. MCCRERY. Well, it seems to me, Madam Chairman, we ought
to write Mr. Kuhn or Dr. McClellan and advise them to contact
Dr. Orange's organization, both the association and maybe his
hospital, and seek their input. They have got some good data. I
don't know why they haven't contacted you so far. What are they
doing? Who are they contacting? Do you know, Dr. Orange?
Dr. ORANGE. Through the quad A-I we actually have had
dialog with CMS and it has been very----
Mr. MCCRERY. You said that before. You said also you
weren't aware of the study that HHS was doing. Okay. Thank you.
Chairman JOHNSON OF CONNECTICUT. Mr. Hulshof.
Mr. HULSHOF. Thank you, Madam Chairman. I appreciate all
the witnesses that are here, and I appreciate the Chairman
bringing this issue forward. Again, I think it is because of a
lesson that we learned after 1997 with the balanced budget
agreement, in a bipartisan way, in fact, some of those probably
here in the room who remember the markup, there were 39 Members
of the full Committee back then in 1997, and the Medicare
changes, if memory serves, passed by a 36 to 3 vote. The reason
I remember is because I was a freshman and I remember
everything that went on that first year that I was here.
I think what happened, of course, as we look back at BBA
was perhaps we weren't as diligent in overseeing those changes
that were made, because it had some real difficult challenges,
it provided real difficult challenges for a number of sectors,
and I think Congress was slow to respond to those unintended
consequences. That is why I think this is so important,
because, again, with the Medicare Modernization Act, and as
these changes are being implemented, it is important to do just
what you have done, and that is provide us with the information
and the follow up.
Please let me suggest to you don't let today be the end of
your journey, but, again as Mr. McCrery talked about, continue
to provide us information. I would probably say, Mr. Schnell,
as you were sitting through the first panel, you had to take at
least some encouragement from at least the tone of questions
from those of us up here, because as I look at Exhibit C of
your testimony, which you call quotes, we call verbatim, what
have you, it was as if I was, again, at the community cancer
clinic in Columbia, Missouri, listening to some very dedicated
individuals who said almost verbatim these same things. So, I
appreciate the dilemma or where we are moving.
Again, if we could make those changes. If Mr. Kuhn tells us
in some aspects it doesn't take an act of legislation, but they
can be done administratively, we will learn that as well. I do
want to ask you, having sat through the previous panel, one of
the suggestions you have made in your written testimony on page
5 is to reevaluate existing drug administration payment codes.
As you probably heard, I think not only Mr. Kuhn, but Dr.
Miller said, and I know MedPAC actually in their report has
shown an increase in the utilization of drug administration
codes. So, are we saying the same thing, or help clarify then
maybe what MedPAC or what Mr. Kuhn has overstated, if in fact
they have overstated the use of these administration codes?
Dr. SCHNELL. Yes, sir, I would be glad to speak to that. We
believe that MMA held immense promise for our community. The
problem is they didn't deliver in developing codes that address
the magnitude, intensity and complexity of service that we
provide. I have been asked to add that we are highly supportive
of H.R. 4098, the Community Cancer Care Preservations Act,
sponsored by your colleague Mr. Ramstad. We have 74 sponsors on
that and it contains a majority of things we would like to see
happen. I might also add that the exhibit to which you referred
contains anecdotes from a small number of people. We have many
more, but, I truly dare say that if I pulled any community
oncologist that I know in any part of the country, we would
come up with similar quotes.
Mr. HULSHOF. I appreciate that. For the record, I think I
misspoke earlier when I said Secretary Shalala in 1998 talked
about the average wholesale price. I think it was actually the
year 2000. I remember it had been an election year. I just
remembered the wrong election. I remember visiting with our
local cancer oncologists, or community oncologists too about
the concern about even changing AWP to this new methodology.
So, I appreciate that your organization agrees that something
needed to be done, because obviously within AWP you were
picking up the practice expense and you were dealing with, for
instance, the very technical requirements for oncological
nurses and technicians and what have you. I think this is--the
intent, at least, is to have a better, more transparent system,
so that you are reimbursed for the drugs adequately and that
there is a practice expense specifically within this. Insofar
as this is deficient, we hope to continue to have this dialog
so that we can make whatever corrections are necessary. Again,
I appreciate all of you being here today. Thank you, Mrs.
Chairman JOHNSON OF CONNECTICUT. Thank you. Dr. Schnell, I
agree that it was the coding process that fell down, and I want
Mr. Hulshof to know that it is part of that problem of the
changes in medicine up against a very old law and a very old
process. The idea of practice expense was kind of stuck in the
old world of receptionists and nurses and delivering
chemotherapy is much more of a clinic operation. It requires a
lot more overtime capability, and we could never get that
picked up, even though we worked hard on trying to get
oncologists involved in that process. So, it was a
disappointment. It is very hard to get back at it now, but that
is something that I hope that as we get them focused on how the
payments per treatment type have declined, we will begin to be
able to get at that.
Mr. Friedman, if you are going to get reimbursed at ASP
plus 4.4 percent, what gives you confidence that you can
deliver these drugs to community oncologists for under ASP plus
6 or plus whatever they are going to get paid? How are you
going to manage this problem that they won't get paid ASP plus
6, they will get paid ASP plus 4 at the best, because they
aren't going to get some of the discounts that bigger
purchasers can get? How will you be able to serve them in a way
that will actually save them money?
Ms. FRIEDMAN. We actually don't manage that end of it. Our
job is to deliver the product and then get reimbursed ourselves
from CMS and the co-pay side.
Chairman JOHNSON OF CONNECTICUT. I see. Of course.
Ms. FRIEDMAN. So, we are not involved in the pricing part
of what happens within the oncologist's office or any other
specialist, or any other physician that signs up for the
program. Our job solely is to make sure that the drugs are
there for the patient.
Chairman JOHNSON OF CONNECTICUT. You certainly had a lot of
experience in this line of distribution, and I am glad someone
is out there to try the CAP initiative, and it is surprising
that only one vendor was willing to take it on. Dr. Bailes and
Dr. Schnell, why don't you see this as a positive possibility?
It eliminates your doctors' exposure to loss on the price of
Dr. BAILES. Well, ASCO does not have a formal position on
the Competitive Acquisition Program. That is an individual
practice decision. There are issues with it, Madam Chairman,
that need to be addressed, we believe, in addition to the
administrative issues that were mentioned. For instance, one is
the ability of a vendor to seize shipment of drugs if a patient
or cancer patient or any patient is 45 days or more late on
payments. There is also the inability to take a CAP drug from
one office to another for those practices that have multi-site
jurisdictions, and patients are often treated in different
sites in those areas. So, those we see are two major issues, in
addition to the extra administrative activity in the practice
that is required because the drugs are specific to the
individual patient when they are shipped.
Chairman JOHNSON OF CONNECTICUT. Mr. Friedman, do you care
Ms. FRIEDMAN. I happen to agree. It is part of our
testimony as well that we should be able to send drugs to where
the physician wants, even in multiple locations. Part of the
problem that we see is in the rural locations where the
physician only attends that office maybe 1 day a week. How do
you get the drugs there? There is no staff to accept the drug.
So, having the drug sent to the main office and then carried
there we see is not an issue as well. We appreciate the point
on the co-pay. We are concerned about that as well. In past, I
believe the physicians did have the ability to step in, if they
wanted to, and we would like to open that up again.
Chairman JOHNSON OF CONNECTICUT. Any other comments on the
subject of the CAP program? Thank you very much for your
testimony. These are difficult problems to work out, but I am
glad to have heard all of the parties today and hope we will
make some real progress over the next couple of months. Thanks.
This hearing is adjourned.
[Whereupon, at 3:35 p.m., the Subcommittee was adjourned.]
Statement of J. Jay Baker, Greenbrier Oncology Clinic,
Lewisburg, West Virginia
I am a board certified medical oncologist who has been in practice
for thirty years, the last fifteen years as a solo practioneer in a
rural community in West Virginia. There is a very large population of
retirees here, which helps explain the fact that approximately seventy
percent of my patients are insured through Medicare, many without co-
insurance. In the same medical complex there is a freestanding
radiation therapy facility. Together, we provide what is felt by the
community to be excellent cancer care. The nearest facility to offer
this type of care is 55 miles away, while chemotherapy alone is offered
a bit closer, 45 miles away in Virginia.
Since January 2006 when the latest Medicare changes were put into
full effect, I have lost money each and every month . . . totaling
nearly $125,000 thus far. I can say that nearly all of this loss has
come as a result of changes in reimbursement from Medicare, especially
the underfunding of the administrative costs incurred when treating
patients. I have tried to eliminate overhead as much as possible in
hopes of finding a way to keep this office open. As you are aware, many
offices are sending their Medicare patients to the hospital for
treatment, but in this small community hospital, that is simply not an
As a consequence of the above, I am being forced to shut the doors
to this office and close down my practice, thereby depriving this area
of quality medical oncology service. I see no other way out of this. I
do not believe that medical oncology can survive in a rural setting in
the present circumstances, and I am a prime example of this. It is my
hope that this committee will somehow see the errors of the present
situation and take appropriate steps to correct them. It will, of
course, be too late for this practice, but perhaps others can be saved
and thereby continue to offer quality care to patients who don't happen
to live near a population center or cannot afford to drive 50 miles one
way to receive care. I know you have received reports of practices
closing ``satellite'' clinics in some areas, but this is a report of
one entire practice being forced out of business totally . . . and I
dare say that I am not the first, nor will I be the last if Medicare
Thank you for you attention to this testimony.
PS . . . I have not drawn a paycheck for the past month and a half!
Statement of Steven H. Collis, AmerisourceBergen Specialty Group,
Madam Chairman and members of the Committee,
AmerisourceBergen Specialty Group and its affiliates provide
pharmaceutical services to pharmaceutical manufacturers and healthcare
providers in the United States and Puerto Rico, and Canada. We
distribute brand name and generic pharmaceuticals to various healthcare
providers, including acute care hospitals and health systems,
independent and chain retail pharmacies, mail order facilities,
physicians, clinics, and other alternate site facilities, as well as
skilled nursing and assisted living centers.
At ABSG, our emphasis is bringing specialty pharmaceuticals from
the manufacturer to the physician to the patient. We help manufacturers
improve their product launches and expand their markets. We ensure that
provider organizations receive the specialty products they need, when
they need them most. We give physicians the resources that improve
their practices and patients the medicines that improve their lives. In
addition to delivering products, that means related services such as
reimbursement and consulting services, logistics services, and
In short, your hearing today is to examine the costs for physician-
administered drugs. That's something we know about because providing
these drugs to physicians is what we do.
1. CAP Program Design Places Unrealistic Burdens
The design of the program places unrealistic burdens on competitive
access program providers (CAPs), burdens that have already discouraged
entry by many prospective CAPs.
Geographic Scope. The geographic area that each CAP must serve is
too large. The additional requirement to serve U.S. territories imposes
a significant burden with higher risk of co-pay issues. In order to
enhance the likelihood that the CAP program will meet Congress' goals,
we recommend you revise the requirements so that CAPs are only required
to serve physicians in the 50 states and Washington DC.
Inexpensive, Low-Margin Drugs. The CAP program tries to do too much
and, in doing so, it forces too many low-cost drugs (for which
physicians face relatively less economic risk) into the program. While
the average bid NDC was about $280.00, the median bid NDC was only
about $59.00. If there were an average 6% gross profit, that would mean
the CAP would have gross margins less than about $3.50 on one-half of
its products. That is not adequate. We recommend that you eliminate any
NDC with reimbursement under $200.00.
Risk of Unprofitable Orders. The cost to process and ship an order
will vary by the size of the order but, on average, it will be
proportionately more for small-dollar orders. We recommend that you
establish a minimum size for all orders, at least $15,000.00 for
oncology drugs and $5,000.00 for all others. Additionally, we recommend
that you allow CAPs to establish a per-order charge of at least $50.00
to compensate CAPs for their additional dispensing costs.
Too Many Specialties. Again, the CAP program design tries to do too
much and, in overreaching, it makes failure more likely. We recommend
that the CAP program focus on key specialties: Oncologists,
Rheumatologists, Urologists, and Ophthalmologists.
Problems Collecting Co-Pays. Challenges in collecting co-payment
after administration of the drugs to patients makes the CAP program
operationally unattractive. Outside the CAP program, physicians and
specialty pharmacies collect co-payment before services are performed
and drugs are dispensed to the patient. Doing so allows the provider to
minimize its economic risk. If there's no payment, there's less risk
because the drugs won't be dispensed. We recommend that you allow CAPs
to collect co-payments from patients (either directly or through the
physician) before services are provided in order to mitigate the high
potential for uncollectible payments from patient, especially those
Risk of Waste. There is a significant potential for waste,
especially with some of the high-cost specialty drugs (e.g. Erbitux,
Velcade, Alimta, etc.).
Single-Use Units. With single-use vials, a physician might
prescribe 3.1 vials of an expensive drug and the CAP would dispense 4
vials. If CMS, after the fact, decides that use of a large single-dose
vial was inappropriate and the physician did not act in good faith to
reduce waste, the 0.1 would be deemed waste. Not only would the CAP not
be reimbursed for the 0.1 vial, it would be denied reimbursement for
the entire vial. Also, it's not clear how CMS determines good faith
from the physician and, if CMS decides the physician did not act in
good faith to minimize waste, the economic risk falls on the CAP--a
party with only limited ability to control or prevent such waste. Even
when doing so was completely appropriate, the remaining 0.9 of the vial
will be truly wasted unless the physician has another patient
immediately in need of the same medicine. We recommend that you allow
CAPs to enter into agreements with physicians to require that the
physician reimburse the CAP if CMS determines the physician acted
Multi-Use Packs and Units. There is also a significant potential
for waste with multi-pack NDCs (e.g. Procrit, Neupogen, etc.) and
multi-dose vial NDCs (e.g. Herceptin, etc.) because, by design, there
is more than one discrete dose per NDC. CMS has indicated that any
remaining doses can be re-directed to other patients based on an
agreement between the CAP and the physician. However, CMS defines CAP's
shipments as prescription orders. Prescription orders are subject to
state pharmacy laws. And, state pharmacy laws generally prohibit doing
Conflicts with State Pharmacy Laws. Design of the CAP program does
not properly recognize the inherent incompatibility with state pharmacy
laws. That is, distributors and pharmacies operate under different
restrictions. Drugs sold by a distributor to a physician may be readily
dispensed to any appropriate patient. However, drugs dispensed by a
pharmacy for one patient cannot be re-directed to a different patient.
A physician cannot simply use extra drugs--whether remaining in a
single-use vial, a multi-use vial or a multi-pack--on a patient other
than the patient for whom the pharmacy dispensed the drug. We recommend
that you recognize the distinctions between distribution and pharmacy
and either avoid conflating incompatible activity or expressly override
contrary state law. Additionally, we recommend that making it clear
that any agreement between a CAP and a physician allowing drugs to be
re-directed from one patient to another will not violate Medicare/
Medicaid fraud and abuse/anti-kickback rules or other laws.
Risk from Providers. The CAP program model introduces a significant
new economic risk. With product purchased by a physician, the owner of
the product has possession of it. And, its owner is the person deciding
how it will be dispensed to patients. Under the CAP program model,
physicians have custody of product they do not own and they decide when
and how much the CAP will need to dispense for each patient. There's no
question the vast majority of physicians are honest. Only a few would
over-prescribe a drug or inappropriately use drugs dispensed for one
patient for another. However, CAPs should be able to monitor use of
product for which they have the economic risk. We recommend that you
allow CAPs to audit the use by physicians of drugs dispensed by the CAP
and to correct any problems that arise.
Incentives Not Aligned. The economic incentives of a CAP are not
aligned sufficiently with those of the physicians it serves. For
example, for high-cost drugs, a physician will have relatively much
less economic risk because administration fees will be substantially
lower than the cost of the drugs, not to mention the fact that the CAP
will have hard-dollar losses for product and shipping it has purchased
and paid for, not the softer loses that a service provider has in not
being paid for lost staff time. We recommend that you allow CAPs to
require that physicians collect co-pays on their behalf.
2. CAPs Have Little Negotiating Leverage
We believe that the CAP program was designed with an incorrect
assumption that specialty distributors and specialty pharmacies have a
high degree of negotiating leverage with drug manufacturers and with
physicians. This is simply not borne out by the facts. More to the
point, CAPs do not have negotiating leverage with drug manufacturers or
physicians--which was clearly shown when the CAP awards were made. The
net result from CMS's competitive bidding was a composite cost
reduction of 0.40% when compared to ASP+6% in Q4 2004 before
application of the PPI--basically no savings. And, actual CAP rates
will be 4.85% higher than ASP+6% in Q4 2004 after the PPI is applied--
making drugs dispensed by CAPs more expensive than those reimbursed
under the ASP system. We recommend that you allow CAPs greater ability
to negotiate with drug manufacturers and with physicians they serve.
3. Current CAP Program Model Unrealistic
The fatal flaw of the current CAP program design was that its model
does not correspond to any existing or viable specialty distribution or
specialty pharmacy economic model. That is, the model seeks to have
CAPs provide services like those provided by a specialty pharmacy but
to do so at margins similar to those in the specialty distribution
industry. There is simply no compensation for the additional risks and
costs inherent in the current CAP program model.
Specialty Distribution. Specialty distribution is:
Low Margin. Operating profit margins are typically in the
low single digits.
Low Service. Many orders are placed electronically
Short DSO Payment Terms. Typically, physicians pay for
product within 10-30 days.
Low Bad Debt. Physicians are typically very good credit
risks. Moreover, most physicians purchasing product are repeat
customers who will not be served if they do not timely pay their bills.
Efficiency Is Key. Specialty distribution is very
efficient, with frequent inventory turns and low costs.
Minimal Returns. While physicians typically return very
few drugs, there are some. Low returns helps keep operating costs low.
However, allowing returns also keeps costs low because unused saleable
product can be re-sold, helping minimize waste.
Specialty Pharmacy. Specialty pharmacy is:
Higher Margin. Operating profit margins are typically in
the high single digits.
Higher Service. Pharmacists typically spend significant
time providing phone consultation, patient specific dosing, etc.
Longer DSO Payment Terms. Typically, full payment is not
received for 1= to 2 months. Often there is a need to coordinate
benefit payments from more than one insurance company or other third-
party payor. And, the pharmacy will typically need to collect a co-
payment from the patient.
Higher Bad Debt. Even with the ability to collect co-
payments and deductibles before services are provided and drugs are
dispensed, specialty pharmacies will typically have more bad debt than
a specialty distributor.
Lower Efficiency. While specialty pharmacies are
typically less efficient, consuming greater working capital than
distribution, they can profitably serve their patient because they
typically have higher operating margins.
No Returns. Under most state pharmacy laws, a patient
cannot typically return drugs once they are dispensed.
Additional Economic Burdens for CAPs. Under the current design, CAPs
have additional economic burdens without additional
Consigned Inventory. Product owned by the CAP is placed
on consignment in the offices of physicians where the CAP has no direct
control over the consigned inventory.
Inefficiency. CAPs must own more inventory to meet the
same level of patients' needs because, when inventory is dispersed, a
CAP cannot readily shift it to physicians and patients who need it when
inventory has been consigned to another physician's office.
Co-Payments. CAPs have no ability to collect co-payments
and deductibles before services are provided and drugs are dispensed.
This increases their bad debt risk and increases their expenses to
Greater Cost. The per-dose cost is typically lower when
purchased in multi-packs or multi-dose vials. Under the CAP program,
there will be greater reliance on single-dose vials, which will tend to
increase overall costs.
Greater Waste. When multi-packs and multi-dose vials are
used by CAPs, it will tend to increase the amount of drugs that is
Minimal Negotiating Leverage. CAPs have little real
ability to negotiate favorable terms with manufacturers and little real
ability to require physician and patient compliance.
For the CAP program to succeed, it's essential that Congress
implement reforms that will remove the economic and structural barriers
of the current design. We at AmerisourceBergen Specialty Group are
available at any time to work with you in helping enhance this program
so it will better serve patients and their physicians.
Thank you, again, Madam Chairman and members of the Committee.
Revise the requirements so that CAPs are only required to
serve physicians in the 50 states and Washington, DC.
Eliminate any NDC with reimbursement under $200.00.
Establish a minimum size for all orders, at least
$15,000.00 for oncology drugs and $5,000.00 for all others.
Allow CAPs to establish a per-order charge of at least
$50.00 to compensate CAPs for their additional dispensing costs.
Focus on key specialties, including oncologists,
rheumatologists, urologists, and ophthalmologists.
Allow CAPs to collect co-payments from patients (either
directly or through physicians) before services are provided in order
to mitigate the high potential for uncollectible payments from patient,
especially patients who do not have coinsurance.
Allow CAPs to enter into agreements with physicians to
require that the physician reimburse the CAP if CMS determines the
physician acted inappropriately.
Recognize the distinctions between distribution and
pharmacy and either avoid conflating incompatible activity or expressly
override contrary state law.
Ensure that agreements between a CAP and a physician that
allow re-directing product from one patient to another will not violate
Medicare/Medicaid fraud and abuse/anti-kickback rules or other laws.
Allow CAPs to audit the use by physicians of drugs
dispensed by the CAP and to correct any problems that arise.
Allow CAPs to require that physicians collect co-pays on
Recognize the increased costs and lower margins that CAPs
face when compared with specialty distribution and specialty pharmacy.
Allow CAPs greater ability to negotiate with drug
manufacturers and with the physicians they serve.
Recognize that CAPs have additional economic burdens that
justify additional compensation and remove economic and structural
barriers from the current design.
Statement of Appearance and Representation
Pursuant to the Committee's rules for appearances, Steven H.
Collis, AmerisourceBergen Specialty Group and AmerisourceBergen
Corporation submit the following information.
Steven H. Collis is Senior Vice President of AmerisourceBergen
Corporation and President of AmerisourceBergen Specialty Group. His
appearance is solely on behalf of ABSG and its affiliates and not on
behalf of or otherwise representing any client, other person or
AmerisourceBergen Corporation, a publicly traded company
(NYSE:ABC), is one of the world's largest pharmaceutical services
companies serving the United States, Canada and selected global
markets. AmerisourceBergen Corporation has more than $58 billion in
annualized revenue, employs more than 13,000 people and is ranked #27
on the Fortune 500 list. For more information, see
ABSG is a wholly owned subsidiary that provides manufacturer
services, distribution services and physician and patient services
through its nine specialty pharmaceutical services divisions,
ICS--Customized outsourcing partner, whose services
include outsourced logistics, contract services, clinical services and
Imedex--An industry leader in providing continuing
medical education to healthcare professionals worldwide, Imedex
organizes more than 80 conferences and projects worldwide each year.
Lash Group--One of the largest reimbursement consulting
firms in the nation, serving pharmaceutical, biotech and medical device
companies with a range of consulting and reimbursement services.
NMCR--International source for analytical research into
medical decision-making and provider of medical education programs
ASD Healthcare--A leading supplier to physicians in
nephrology, oncology, plasma, primary care and vaccine healthcare.
Besse Medical--One of the largest nationwide distributors
of vaccines, biologicals and injectables.
Oncology Supply--One of the largest nationwide
distributors of oncology products and practice management solutions.
Physician & Patient Services.
International Oncology Network (ION)--A group purchasing
and medical education organization serving more than 3,000 community-
U.S. Bioservices--A specialty pharmaceutical services
company dedicated to helping pharmaceutical manufacturers and
physicians improve patient's lives through evidence-based medicine.
Connecticut Oncology Association
South Windsor, Connecticut 06074
July 27, 2005
Congresswoman Nancy Johnson, chairwoman,
Committee on Ways and Means Health SubCommittee
U.S. House of Representatives
1102 Longworth House Office Building
Washington D.C. 20515
Thank you for the opportunity to comment on the impact of the MMA
upon community oncology in support of the hearing held on July 13, 2006
by the House Ways and Means Subcommittee on Health.
The impact upon patients and physicians in the state of Connecticut
has been dramatic. In 2004, the combined net payments from both drugs
and professional fees as well as the 32% transitional payment were
sufficient for oncology practices to continue to care for Medicare
cancer patients at close to a breakeven level. Most practices care for
Medicare patients as 40--50% of their patient mix, so changes in
Medicare reimbursement have significant to the financial stability of
these small businesses.
In 2005, the transitional payment decreased to 3% and the drug
payments changed to an ASP basis. From the first day these rates were
in place, practices found themselves unable to care for Medicare
patients who could not afford to carry supplemental insurance and could
not afford to pay the 20% Medicare co-payment. These patients were
referred to local hospital outpatient facilities (which were not
locally available in several communities because those hospitals had
long before closed their own outpatient infusion centers since care had
shifted to the more cost-efficient physician office sites).
Additionally, Medicare patients from Skilled Nursing Facilities in need
of cancer treatment were also being shifted to any available hospital
facility (even inpatient if the patient's condition warranted) because
of Medicare policy changes making the Skilled Nursing Facilities
responsible for an illogical and incomplete list of cancer treatments.
The Skilled Nursing Facilities refused that responsibility so
physicians were forced to refer such patients to the more-costly
hospital facilities when cancer care was needed. This shifting of
patients without supplemental insurance and those from Skilled Nursing
Facilities has resulted in a real but as yet uncounted additional
financial burden upon the Medicare Part A system, as well as a hardship
and quality of care burden upon the Medicare cancer patients and their
families, which in some cases has adversely affected their care.
Two specific examples: In southern CT, a Medicare woman without
supplemental insurance could not afford to pay the required 20%
copayment for her treatment after Jan 1, 2005, and the ASP+6% payment
was significantly below the practices' costs of purchase and
acquisition of the drugs in that regimen. The practice offered to refer
her to the local hospital (which in this case was accepting patients).
She refused to go, stating that she had been there before and felt the
care, experience and skill level of the non-oncology specific nurses
employed at the hospital was inadequate for her needs, so she also
decided to then forego that treatment completely. THIS WAS AN ACCESS
ISSUE CAUSED BY THE MMA JUST 30 DAYS INTO 2005!
The second example occurred in another town further west, still in
the south of CT. A patient had been receiving her care from the
practice despite being unable to meet her copayment obligations. The
practice was able to continue her care under the old Medicare payment
structure because they could still afford to accept a certain level of
bad debt. Under the 2005 payment schedule, the inability of the ASP+6%
payment to cover their costs of purchase and pharmacy acquisition meant
that the practice was facing more than $10,000 in annual losses for her
care. They were forced to refer her for treatment to the local
There are no longer dedicated oncology divisions in this hospital.
Like most community hospitals across the nation, when the most
appropriate cost-effective care setting became the physician office,
oncology units were closed and oncology-certified nurses migrated to
the physician offices. Nurses on the general medicine floors or even in
the few hospital owned infusion centers are not as familiar with the
complications of caring for cancer patients, especially with the newer
drugs and nursing shifts frequently change during the course of a day's
treatment, creating lack of continuity in what is already extremely
complex care. This patient was referred to the hospital outpatient
infusion center, and the nurse from the physician office called the
hospital nurse to give her information on the specific drug being used.
This drug was very toxic, and even the physician office nurse had
checked with the manufacturer before administering it to learn of any
new information on managing patient comfort and reactions. The hospital
nurse never bothered to follow up on the office nurse's suggestion that
she also could get updated information before administering this
treatment. The patient did suffer complications and reactions,
requiring hospitalization for those symptoms, which led to clinical
depression. Medicare Part A was now incurring costs of the
hospitalization, and the additional medical and mental complications
from the differences between her physician office based treatments in
2004 and this new locus for treatment in 2005. THIS IS A DIRECT EXAMPLE
OF THE ACCESS AND QUALITY ISSUES RESULTING FROM MMA WHEN PATIENTS ARE
REQUIRED BY POLICY CHANGES TO SEEK TREATMENT IN SETTINGS OTHER THAN THE
PHYSICIAN OFFICE, WHICH HAS BECOME THE GOLD STANDARD FOR MANAGING
One solo oncologist in CT closed his practice and was packing boxes
and moving them out as the MMA was being signed into existence.
Another solo oncologist, the only practicing oncologist in the
town, closed first his infusion center in February of 2005 because of
the inadequacy of the ASP+6% formula to cover his costs of both
purchase and acquisition, and then his full practice in May of 2005
because the remaining professional rates were inadequate to sustain a
practice without infusion services. Patients are now driving almost an
hour on back winding roads to seek treatment in the nearest town.
Several respected oncologists have moved forward their retirement
plans, some well below retirement age, because of the significance of
Medicare patients in their patient mix and the fact that in 2004, net
net Medicare payments were close to breakeven, in 2005, they dropped
below breakeven unless you were careful to manage your patient bad debt
potential and evaluate treatments and refer patients elsewhere for
treatments that would have incurred significant financial losses, and
by 2006, there is no practice that is not losing money on every
Medicare patient they treat, for both professional and drug services.
One of those physicians just retired on July 1, 2006, in the prime of
his career, because of the financial burden as well as the emotional
toll of not only caring for cancer patients, but the added toll of
explaining and guiding them through a system that he feels has let them
The testimony of the Community Oncology Alliance and ASCO have
highlighted the specific problems with the ASP+6% methodology and the
fact that professional services required for the safe and effective
delivery of cancer care are not reflected in the professional codes or
reimbursement rates set by CMS. The Relative Value Units and practice
expense bases were created decades ago when the majority of current
cancer treatments did not even exist, and the physician offices were
not the efficient models of acute care and even emergency care service
for cancer treatment that they are today. I testified before CMS and
the RUC review committee as to the inadequacy of these codes and base
rates in 2004, and those issues have not been addressed fully to this
Even large medical groups in CT are writing to me now, citing the
impact they are seeing on their private reimbursements when insurers
are mimicking the flawed 2006 Medicare payment system. When large
medical groups in the center of the state are joining private oncology
practices of all sizes across the state in a common message ``We cannot
hold on much longer, we are worried about our ability to continue to
stay in practice,'' THIS INDICATES A SEVERE ACCESS ISSUE CAUSED BY
FLAWS IN THE MEDICARE PAYMENT SYSTEM.
Bridgeport Hospital announced in 2004 that there were specific
drugs, without generic alternatives and essential parts of standard
cancer treatment regimens, that they were no longer to provide in the
hospital, since they could not afford to provide these drugs: among
them were Avastin, Rituxan, and Erbitux. This created problems with
access for patients in 2005, and by 2006, when local physician
practices also became financially vulnerable for all levels of Medicare
patients, even those with supplemental insurance, THIS HAS CREATED AN
ACCESS PROBLEM FOR PATIENTS WHO NOW HAVE TO TRAVEL WELL OUT OF THEIR
AREA, IF THEY CAN, TO SEEK CARE.
I appreciate your time and am happy to discuss the situation in CT
with you should you wish. Please heed these messages. Oncology care is
in crisis due to the flawed methodology used for the ASP policy as well
as the continued lack of recognition of the costs and resources
required to provide care in the most cost-effective and medically
efficient setting, the physician office.
Dawn Holcombe, MBA, FACMPE, ACHE
The West Clinic
July 18, 2006
The House Committee on Ways & Means Health Subcommittee
Room 1102 Longworth House Office Building
Washington, DC 20515
Dear Chairman Johnson & Members of The Ways & Means Health Sub-
The changes under MMA have put our clinic into a significantly
compromised situation. As a result, we are no longer able to treat all
of our cancer patients in our facility. Many are being shifted to
hospital settings--nearly ten times the amount that were shifted last
year. The hospitals have placed significant limitations upon their
willingness or ability to accept them. Thus, patient treatments are
being delayed or shifted outside the communities that we serve.
The West Clinic has offices in Tennessee and Mississippi and serves
a patient base within 150 mile radius of Memphis, Tennessee--including
West Tennessee, North and Central Mississippi, Eastern Arkansas,
Southeastern Missouri, Southwestern Kentucky, Northeastern Alabama, and
Northern Louisiana. Last year we had over 110,000 patient encounters
and nearly 500,000 phone calls. Our clinic sites intervened to prevent
thousands of emergency room visits and hospital admissions. That was
our story in 2005.
In 2006, the full impact of MMA has hit and we are no longer able
to care for our patient population as before. Major shifts of patient
care are now occurring and proactive interventions that avoid ER visits
and hospital admissions are now more limited.
The vast majority of the best treatments for colon cancer, lung
cancer, breast cancer, lymphoma, and many other diseases are now
reimbursed significantly below cost. For the first time in the 27 year
history of our clinic we are facing a serious deficit situation. How
can this be? First, the bad debt scenario. In our communities nearly 4
out 10 Medicare patients have either Medicaid, no secondary, or
insufficient co-insurance. The net effect is the inability to collect
the full 20% co-pay on nearly 30% of our Medicare patients. This alone
puts our reimbursement for drugs below ASP. Secondly, the real costs of
delivering 21st century cancer care are not covered. We have
sophisticated pharmacy operations in all of our sites. Yet, the cost of
the storage, preparation, inventory, safety, and other essential
pharmacy operations is not reimbursed. Third, we have faced over 35
drug price increases since January 1st of this year. Thus, we have to
wait at least six months for the Medicare reimbursement to reflect
these increases. Fourth, neither our oncologists nor our nurses are
fully reimbursed for the work that they do. Currently, there is no
reimbursement for oncology treatment planning. Our oncologists are the
point person on the management of patient care--including chemo,
surgery, radiation, home health, hospice, and every aspect of the
entire continuum care. Also, the essential work of our nurses is
enormously undervalued. Most noteworthy is the pittance that is paid
for the second and subsequent hours of chemotherapy. Given the
sophisticated and complex nature of the many of the new chemotherapy
regimens the focused intensity of the second and subsequent hours of
chemo is equal (and at times more) than the initial hour. Fifth, the
prompt pay discount inclusion in ASP lowers our effective reimbursement
by at least 2 percent.
Meanwhile, commercial insurers are now pushing for setting their
reimbursement based upon the current Medicare model. Should they
succeed, we will essentially have to cease operations. This will leave
thousands of cancer patients fending for themselves and over 300
employees out of work. As the largest and leading cancer provider in
the 150 mile radius of Memphis we consider this a tragedy.
On July 13, 2006 your committee held hearings on the salient
concerns resulting from MMA. Your efforts to look into this matter are
most appreciated. Clearly, this was a step in a positive direction. As
one who sits in the clinic--time is of the essence--regarding real
solutions to these concerns. Cancer clinics operate as month-to-month
businesses relying solely on the revenue for providing care. We have no
endowments, foundations, or corporate investors. We can only go so much
longer getting paid less than it costs us to provide care.
Some may say, why then, are you not going to be a CAP provider?
Very simply, CAP will lead to major disruptions of care (as 35% or more
treatments change the day of the visit) and secondly, CAP will actually
cost us more--given the added administrative expenses. Thirdly, CAP
will create such confusion with individual patient inventories that the
costs will increase as will the likelihood of medical errors. Given our
annual malpractice bill of $555,000, we cannot afford to increase our
risks. Most importantly, we will not subject our patients to the
medical risks associated with CAP or the harassment they will receive
from the CAP vendor when they cannot afford the 20% co-pay and they end
up being sent to a collection agency or the threat of having their
treatment discontinued. CAP is a great idea of maintenance
medications--terrible for oncology.
Anyway, where does this leave all of us?
The time and need for solutions is now. Many sound and reasonable
solutions for balanced and permanent reform for cancer care
reimbursement have been proposed. We hope that the committee will move
legislation and that CMS will move forward with administrative fixes
before the crisis exacerbates to a point where like the crisis in IVIG,
patients lives are at risk. I am afraid that we are just a few months
away--at most--from this happening.
Steven M. Coplon, MHA, CMPE
Chief Executive Officer
I am practicing medical oncologist, and I have been in practice in
Tyler, Texas for 22 years. Tyler is a city of 80,000 and is a regional
referral center for most of East Texas' rural citizens.
The MMA and its attendant cuts in reimbursement have a terrible
impact on the quality of care we can offer our Medicare patients. As
background, let me state that to provide high quality cancer care in
the community setting (and 80% of all American cancer patients receive
their care in this setting) we have to endure an enormous overhead. We
require a highly trained staff (a pharmacist, 2 ``chemo'' nurses, 2
physician's assistants to support the patients of a 2 doctor oncology
practice: annual salary for these employees alone exceeds $350,000),
sophisticated billing and coding staff and equipment, and the drug
bills which are in the millions. Our cognitive services are reimbursed
on the same scale as primary care physicians who have an overhead which
is but a fraction of ours. To fund this quality of service, we must
have some other source of revenue. One would think that source would be
chemotherapy administration, yet; Medicare reimbursement for our chemo
drugs is less than our cost for 38 of the 42 drugs which we purchase
regularly. Only if the patients have a supplemental insurance which
will pay the 20% difference between actual Medicare payment and the
Medicare ``allowable'' charges can we treat our patients in our own
clinic. If we treated Medicare patients without supplementary
insurance, we would be hundreds to thousands of dollars ``in the red''
on each treatment. Our only alternative is to send outpatients with
``Medicare only'' insurance to the local hospital's outpatient chemo
units for treatment.
We are fortunate to have two hospitals in Tyler that are willing to
help our patients, but the hardship to these individuals can be
significant: 1. JW is a 70 year old widower who is virtually paralyzed
by a disease called chronic inflammatory demyelinating polyneuropathy.
He lives alone, and his very function depends on monthly infusions of
IVIG (intravenous immune globulin.) He has Medicare ``only'' insurance,
so with the institution of ASP-based reimbursement and the further cuts
in reimbursements for infusions in 2006, we have bee forced to send Mr.
W to the hospital outpatient setting for treatment. He now sits in a
wheelchair for 10 hours taking a treatment he could complete in our
office in 4 hours. 2. EF is a 68 year old retired nurse with ``Medicare
only'' needing chemotherapy fro high risk stage 3 colon cancer. She
spent 11 hours on the fourth of July at the hospital taking what would
have been a 3 hour treatment in our office. The next available
appointment time for her treatment would have been 2 weeks later, and
that was simply too long to wait. I could offer you several other
examples. Our patients are educated and well aware of what is at stake.
JW has written letters to Congressman Gohmert, our Senators, and
President Bush. Our patients are angry!
Please fix the problem. Clinic based oncology care is the best in
the world. Don't let it disappear. Please deal with the flaws in ASP
(prompt-pay discounts, several month delays till increased drug prices
are reflected in the ASP, etc.). Please enhance E and M reimbursement
for oncologists. The intensity and the overhead of our job are not like
that of other physicians who are not reimbursed for procedures. Please
save community oncology.
Gary E. Gross, MD, FACP
Statement of Arlette J. Holland, Practice Administrator,
Chestnut Hill, Massachusetts
To Whom It May Concern:
As Practice Administrator for a small oncology practice I see the
day to day impact and ripple effect of reduced Medicare reimbursement.
Two of our oncology nurses are commenting, under separate cover, on the
impact on treatment accessibility, the impact on our nursing staff and
the time it takes to assist patients to get the care they need. I will
be focusing my comments on the effect of reduced revenue on the
Since we are a small practice we do not have the luxury of purchase
power when it comes to buying drugs and medical supplies. We do the
best we can by joining every Group Purchasing Organization we can and
by taking advantage of rebate programs and contract pricing. In the
past we were able to earn early pay discounts from our drug vendors--
but now with the reduction in our reimbursement and it's direct impact
on our cash flow we cannot pay early to receive said discounts. In
fact, the majority of time we are paying our vendors late and incurring
late fees and service charges--sometimes in excess of $5000 a month!
Over time we have lost the ability to purchase from some of our drug
distributors because of late payments and over extending our credit
limits--the result for us is we have fewer opportunities to shop for
best drug pricing. If you factor all of this together and compare it to
ASP+6%, we are on the loosing end. We are NOT able to purchase drugs at
or below ASP+6.
In some instances where we have been able to earn a small profit on
a drug--those few pennies are still not enough to cover the
underreimbursed cost of administering the drug. We are not adequately
reimbursed (sometimes not at all) for IV bags, tubings, dressing
supplies, etc., so those few pennies are not even enough to cover
supplies. You must also look beyond that to other expenses oncology
practices incur--office rent, salaries, employee benefits like health
and dental insurance, malpractice insurances, telephone and computer
systems, office supplies, hazardous waste expenses, medical supplies,
clinical education, licensure and hospital dues for the physicians,
leases on photocopiers and faxes, transcription services, utilities,
postage, lab coat and laundry services--the list could go on and on but
these are things that are necessary to run a safe medical practice that
offers quality care to its patients. How do these things fit into the
pennies we are reimbursed for drugs, administration services and E & M
Practices like ours are fronting the money for all of these things
and are quickly falling behind! Some weeks we don't even meet payroll
and our physicians then do not get paid AND our vendors don't get
paid--putting us farther and farther behind.
Our practice, with three treatment facilities, is like many others
across the country--we are not extravagant. We run bare bones. There
are no frivolous expenses, we have not had salary increases for our
staff in three years. We are in fact understaffed--our nurses travel to
all three locations to treat patients because we cannot afford adequate
staffing. In some offices we are unable to treat patients on certain
days because our nurses are required to travel to another of our sites.
Our nurses not only treat our patients but also assist our billing
department in screening patients' insurances for coverage and
preauthorization requirements. The nurses are our social workers and
patient advocates, they expend a huge amount of their time assisting
patients in prescription coverage, copay assistance and patient
education. How is this reimbursed? Our billing and secretarial staff
are down to the bare minimum; often having to cross cover for each
other on busy days or vacations. Because we are not being able to
afford adequate staffing in any department, the patients sometimes feel
the impact on the quality of their care--some days there just are not
enough staff and not enough hours to accomplish all that is required
for patients and thus patients sometimes experience a delay in
The Cancer Center of Boston has always prided itself on the ability
to see new patients within 24 hours of initial contact--we still strive
to meet that but find that treating the patient the same day as we had
in the past is no longer a reality in our practice. Not only do we
clinically review the appropriate treatments for patients but now these
treatments must be analyzed for reimbursement. Will we be reimbursed at
all? Will we be under reimbursed? We can no longer afford to stock our
pharmacies for ``potential'' treatments but are forced to order daily
for treatments that have been prescheduled.
We have yet to send our patients elsewhere for treatment. Ethically
we feel we can't turn patients away and thus extend every effort to
find an affordable and clinically appropriate treatment. Another
consideration is that the hospitals at which our physicians are on
staff have NO oncology services.
To date we have not closed any of our offices BUT are tenants at
will in two (2) out of three (3) because signing extended leases seems
a poor business decision in view of current reimbursements and future
Medicare is not the only payor at fault here but are the catalyst
for other payors to follow suit.
On behalf of The Cancer Center of Boston I ask the Committee to
continue to review and appropriately adjust reimbursement to adequately
match the reality of cancer care today and to plan for cancer care in
Statement of Horizon Hematology-Oncology, Spartanburg, South Carolina
The current methodology of drug reimbursement is devastating to
small physician practices. For small practices, with one-two
physicians, drug pricing reflects high cost and big loss because we do
not have large volume. This is not taken into consideration, and in
fact it is a benefit to big facilities and a penalty for small
practice. The big volume buying power of large facilities skew the
reimbursement. The large facilities buy large quantities at lower
prices and reap the reward of purchasing under reimbursement while for
small practices current drug pricing reflects a substantial loss, as we
do not have the large volume purchasing power.
Promoting American small business the government should be paving
the way versus making it hard to collect the reimbursement due. For
example, 14-day payment on electronic claims and 29 days with a small
business waiver actually penalties small business and 6% of ASP doesn't
cut it when this payment postponement penalty costs to borrow. Knowing
that the ``Wal-marts'' of oncology can buy anything cheaper than small
A flat 6% tips the scale heavily against small business entities.
Realize when patients are strapped for cash and use a credit card to
pay their coinsurance there is a minimum processing fee of 2+%. So the
reality is that we are not getting ASP+6% when all factors are
considered. This is just another example of the reality of how
inadequate the calculation for reimbursement truly is.
CMS is taking more money out of Community Cancer Care.
The 2005 and 2006 Demonstration was put in place by our legislators
and CMS to offset the drastic reimbursement cuts made to oncologist. As
we all know the 05' demonstration translated into an additional $130
for each chemotherapy infusion for each Medicare Beneficiary and in 06'
an additional $23 for physician evaluation of Medicare Beneficiary with
This is not happening! CMS has given Medicare Advantage Plans a pass.
Change Request 3634 Transmittal # 12 from CMS, which states that
``only Medicare beneficiaries who are not enrolled in a Medicare
Advantage plan are included with the demonstration.''
Shocking! So Medicare beneficiaries are receiving inferior benefits
and oncologists are receiving inferior reimbursement. This is no
Advantage Plan at all!
In 2005 each time an oncologist gave chemotherapy to a Medicare
Beneficiary with a replacement plan they lost $130 each time and are
losing $23 per physician encounter in 2006. On a national scale how
many millions/billions does this constitute? And this savings is passed
on to private insurance companies.
I doubt this loss revenue is being considered in the figures that
the legislators are touting around Washington. Shocking isn't it!
Hunterdon Hematology Oncology
Flemington, New Jersey 08822
July 13, 2006
Thank you for giving me this time to share how I feel about this
issue. If you need further information please feel free to call.
I came into oncology management 6 years ago. At that time, I too
thought that the way reimbursement by AWP was incorrect because there
were a handful (5) of generic drugs that were paid at brand name
The MMA has turned a Molehill into a Mountain- Act.
Each drug, brand or generic, is assigned a separate NDC number. The
simplest solution would have been to reimburse a % by billing the NDC
#. There would never have been an issue of any drug being reimbursed
I had mentioned this 3 years ago to Steven Phillips at CMS and was
told how the computer system would need to be changed in order to
handle 11 digits. I believe it would have been more cost effective to
changed the system to handle NDC#'s and there would not be any issues
of drugs ``Below Water.''
We have 29 drugs ``below water`` in this 3rd quarter. Admin fee do
not cover the difference between cost and reimbursement. Where do I
make up the difference?
example: Neulasta costs 2366.84 we are reimbursed 2148.71 if we do
not reach our goal we are minus 218.13. If we reach our goal we could
make 1% over cost! That's it!! Admin code pays 21.52. This does not
even cover the cost to see this patient!
We have to check each patient's regimen before treatment to see if
we can afford to treat them here or if we need to send the patient to
the hospital for their treatment.
Administration fees must be increased to cover the true expenses.
What are we saying to our seniors? That they are not worth
receiving the best care possible? Our seniors have worked hard for
their benefits and to be turned over to an all day treatment that could
have been 2 hours in the outpatient setting is atrocious.
I spend my day looking at websites shopping for better drug prices
because everyday there are price increases from the pharmaceutical
companies. The pharmaceutical companies are not even allowed to help
Doctors office as they did in the past. Educational grants and any help
they could have provided has been eliminated.
Next solution, we tack on 6% to our invoice amount. This way
everyone would be paid fairly regardless of the size of the practice.
It would be easier and more cost effective to send in prove of
I am not naive. I realize that the method that is being used forces
us to find the ``Best'' prices but there are so many flaws that will
never be remedied with the system the way it is. We can not purchase
drugs at some of the discounted prices because of volume. Also,
hospital prices, incentives, and rebates should not be included in the
averaging. If I can pay my bills on time I should be able to enjoy a %
off my bill just like any other business. If I meet a quota for a
rebate I should be entitled to that rebate. This is part of running a
business. If I can not reach the levels I shouldn't be penalized by
having to pay more for the drug! That does not make any business sense.
Statement of Samuel W. Needleman, Oncology Associates of Stephenville
Hematology-Oncology, Stephenville, Texas
I have a rather short reply. I am a compassionate, Triple Boarded
Heme-oncologist who came to a Texas Town of 25,000. The CEO of the
local hospital had done a study that showed a need for one full time
Oncologist. I have been very well received and see about 300 consults a
year. My start up was underwritten generously by the hospital. I
collect over a million dollars a year, but we lose so much on
chemotherapy that the hospital has cut my salary from $300K to 50K, and
I shall be forced to leave this community. I was very happy here and it
will hurt the community. The current system of reimbursement does not
allow small groups without super specialist billing experts to operate
without losing money. It has driven me away from a small community I
have loved and served well.
Submitted by Physicians of Southeastern Gynecologic Oncology
We are writing to let you know of the impact of the reimbursement
changes resulting from the implementation of the Medicare Modernization
Act (MMA). As you are aware, the intention of the MMA was to correct
over-reimbursement for chemotherapy drugs and under-reimbursement (or
no reimbursement) for essential services relating to administration of
the drugs. In the planning phase, it was estimated that the reduction
to community cancer care would be about $4.2 billion over 10 years. A
more recent estimate using real world figures from community
oncologists shows the impact to be more than three times that--$13
billion over 10 years.
For lawmakers used to the realities of large numbers in budgeting,
this may sound feasible. But on the local level, it is untenable. Just
two years into implementation, the implications are far-reaching,
severe, and at a precipice.
In our gynecologic oncology practice where we care for women
diagnosed with ovarian, uterine, cervical, vaginal and vulvar cancers
(about a third of whom are Medicare beneficiaries), we have seen
precipitous drops in Medicare reimbursements. In fact, our
reimbursement rates for Medicare beneficiaries have dropped by 30%
since the phased MMA changes begin to be implemented in 2004. Although
many sources have painted oncologists as making huge profits on drug
reimbursement, the reality is that oncologists have huge outlays for
administering chemotherapy drugs: staff pharmacists; highly trained and
experienced oncology nurses (often with special certification); time
for treatment planning (changing dosages based on side-effects;
changing regiments based on efficacy for that particular patient;
changing treatment dates for emergencies, etc.); special equipment in
the office for preparing chemotherapy safely; charges for safely
disposing of chemotherapy-related waste and more. These costs are not
accounted for in any Medicare reimbursement rates or methodology.
Any business with such a dramatic decrease in income must adapt. We
are no exception. In order to keep our doors open, we have had to
change the way we do business. In the past, our patients received
chemotherapy in our office. This enabled us to provide excellent care
for our patients: they could see the physician on the same day as their
chemotherapy (reducing trips for patients who are already exhausted
from their disease and treatment); providing continuity of care (the
same oncology nurse provided their chemotherapy at each visit, making
the patient comfortable enough to voice important concerns that they
wouldn't ``bother the doctor with'' and allowing the nurse to notice
changes in patient's clinical status); and providing quicker care
(patients who must register in the hospital face considerably longer
wait times). Now, Medicare beneficiaries without a secondary insurance
must be treated in the hospital, increasing their treatment time and
travel time, requiring multiple visits for physician follow up and
treatment, and decreasing continuity of care. We cannot risk their
inability to pay their copayments as this could put us in jeopardy
financially. They cannot have labs drawn in our office, receive
important supportive care injections in our office or see the physician
on the same day as treatment. This, of course, is just the first step.
We have already considered sending all Medicare patients regardless of
secondary insurance to the hospital. We have not done this because it
is important to us to continue to provide our patients with the best
care we can. But this may become necessary in the not distant future.
As we said at the beginning of this process, changes to Medicare
are only the beginning. Private insurers follow Medicare's lead. This
summer, Blue Cross Blue Shield of Georgia announced that they would be
reducing our reimbursement rates by 11%, effective July 1, 2006. This
affects another 30 percent of our patient base. We expect other large
private insurers to follow, compounding the problems set into motion by
If reimbursement rates continue to drop from government and private
payors, our practice will have no choice but to send all of our
patients to the hospital for their chemotherapy. We are not the only
practice facing this reality. Transferring all the patients who
currently receive chemotherapy in a community oncologist's office into
the hospital will overwhelm the system. This is already happening in
On a larger scale, inadequate reimbursement for chemotherapy
affects cancer care throughout the country:
Older oncologists are retiring.
Fewer new physicians are choosing oncology as a
Satellite offices serving rural communities close to
patients' homes are closing making cancer treatment more difficult if
not impossible for some patients.
Most research protocols are administered in community
clinics. Disabling these clinics hinders the pace of oncology research
and the delivery of life-saving treatments to the patients who need it.
Hospital infusion centers will likely be overwhelmed by
the sudden demand when a practice must stop providing chemotherapy or
worse, must close its doors. This causes unacceptable treatment delays
that harm patients.
Fortunately, this scenario does not have to occur. Legislation in
the House and Senate (HR 4098 and S 2340) includes provisions to solve
the problems with drug reimbursement created by rushed implementation
of the ASP system, create payment codes for essential services that
Medicare does not currently reimburse for (i.e., treatment planning and
pharmacy facilities), and restore appropriate payment for drug
administration and deal with the reality of bad debt. These provisions
will not make oncologists wealthy, but will allow them to continue to
provide world-class cancer care to all Americans. We implore you to
save cancer care; the situation is urgent and deteriorating. Congress
must act now to preserve the best cancer care system in the world.
Medical Specialists of Fairfield
Fairfield, Connecticut 06824
July 26, 2006
To Whom It May Concern:
I am the managing partner for a group of five hematologists and
medical oncologists in Fairfield, Connecticut. We perform about 90% of
our chemotherapy infusions as an outpatient in our private office and
about 10% in the infusion center of the hospital. Over the last seven
months, it is obvious that we are sending more patients to the infusion
center because of pharmacoeconomic issues. The ASP reimbursement system
for drugs clearly has flaws that need correcting. The Medicare
Reimbursement Policy of ASP plus 6% is clearly not adequate when we
factor in bad debt, collection costs of 2% to 5%, and the low rates
To show a specific example, we are sending patients who receive
Neulasta white blood cell factor support injections to the hospital if
they have Medicare or private payer Medicare Choice plans. The
reimbursement for Neulasta is $400 less than our costs, per injection.
We have made it an office policy to send all Medicare patients
without supplemental insurance to the hospital infusion center because
drugs for these patients are ``underwater'' and do not cover our costs.
Many patients have experienced delays in their chemotherapy because of
staffing and scheduling issues to the hospital, as well as an
inconvenience factor, having both to go to the infusion center and then
come to see me for followup, whereas other patients with adequate
insurance and adequate reimbursement are being seen the same day as
chemotherapy. This reduces the strain both on the patient and the loved
ones, significant others, or friends who escort these patients who can
seldom come alone.
I hope this is helpful and allows you to see the wisdom of
increasing reimbursement for things like pharmacy handling, patient
coaching and counseling, medical treatment planning, supplies and
regulatory compliance costs, equipment costs, and increased staff costs
that we are now bearing the brunt of and are not being covered in the
Thank you for your attention to this matter.
Glen A. Reznikoff, M.D., F.A.C.P.
The Cancer Center of Boston
Plymouth, Massachusetts 02360
July 27, 2006
This communication is being written to express my concern for the
reimbursement formula currently used to calculate payment for oncology
drugs in the community office setting.
As an oncology nurse in a small community office, I am very
involved in the purchasing, dispensing, and billing of oncology drugs
within our practice. I cannot fathom that the committee in charge of
developing, implementing, and evaluating reimbursement formulas for
community oncology practices have any working knowledge of how these
oncology offices function.
Our physicians used to be able to decide upon a treatment for their
patients based on what chemotherapy drugs and supportive drugs were the
most appropriate for each patient; however, now the physicians are
sometimes forced to alter treatment regimens based on insurance
coverage. I am appalled that patients may be denied the most effective,
possibly life-saving, medications because they do not have the correct
health insurance coverage.
Even patients with primary and secondary health insurance coverage
are not always able to receive the most appropriate medications because
some of those medications cost our practice more to purchase them than
Medicare reimburses for the drug. Since the reimbursement is based on
average sale price (ASP) plus 6%, I am left to wonder who determines
what the average sale price should be. Having purchased chemotherapy
drugs for the past fifteen years, I can tell you for a fact that the
average sale price for small community oncology practices is not the
same as the average sale price for large offices or huge buying
conglomerates. Since we do not have the ability to obtain volume
discounts due to the size of our practice, we pay a much higher price
than buying groups pay for the exact same drug. Thus, when the
medication costs our office more than we are reimbursed, the patient
may not have the option of receiving that medication. This fact
constitutes denial of access to care for our senior citizens, those who
have built this country into what it is today.
In addition to medication reimbursement, another factor is the cost
of administration of the medications. Medicare does not reimburse for
the intravenous bags or any of the supplies and equipment necessary for
the administration of the chemotherapy drugs. All of these items must
be purchased and paid for, whether or not they are reimbursed. Nursing
staff, an integral part of the administration of chemotherapy, must be
paid for their time. What part of the reimbursement covers the cost of
nursing coverage? The reimbursement for the administration codes does
not cover supplies, equipment, salaries, compliance with regulations,
etc. that are a part of the total functioning of a community oncology
Congress must take into account that small community oncology
practices do not have the available cash flow that larger practices
have. We are usually unable to pay the wholesalers according to the
terms outlined and therefore often incur later fees and service
charges, another cause for decreased cash flow. What are community
practices to do when they are unable to pay their bills? What are they
to do when they are reimbursed less for a drug than the purchase price?
Let me tell you that, community practices are beginning to do one of
two things. These practices are either sending the patients to local
hospitals for the more expensive treatments or deciding to treat
patients with the second best treatment available. Many local hospitals
do not offer oncology services; therefore some patients may even be
denied that option. Does this seem like the way you, as Congressmen and
women, would want to be treated or have your parents treated if you or
they had the misfortune to be covered by the Medicare system?
Please do not hesitate to contact me for further information as I
would welcome the chance to discuss this issue in greater detail.
Thank you for your time and your interest in this very important
Donna J. Strong, RN OCN BS
Statement of Talecris Biotherapeutics, Research Triangle Park,
Chairman Johnson, Ranking Member Stark, and distinguished
subcommittee members, thank you for the opportunity to provide the
following statement regarding Medicare reimbursement of physician-
administered drugs. Talecris Biotherapeutics manufactures
Gamunex, an intravenous immunoglobulin (``IVIG'') product, a
critically important therapy for many patients.
Our approach to patient care is simple. We support giving each
patient and his or her physician access to the IVIG brand most
effective for that patient in a setting best suited for his or her
individual needs. As such, we focus our comments on the Average Sales
Price (``ASP'') methodology and its impact on the pricing and
availability of IVIG therapy.
We support the ASP methodology as a means to reimburse adequately
physicians for the cost of acquiring the therapy. Unfortunately, two
coding-related IVIG reimbursement issues are contributing in a
substantial manner to situations where providers and patients are not
able to acquire some IVIG products at a price that is consistent with
the Medicare reimbursement.
To ensure ample access to IVIG across all sites of service we
encourage CMS to commit to a long-term solution by (1) issuing separate
Healthcare Common Procedure Coding System (``HCPCS'') codes to IVIG
products and (2) increasing the payment for administration services to
adequately reflect the cost of providing the service, based on a
thoughtful and careful review of the costs associated with those
services. Our recommendations are completely consistent with the ASP
methodology, and with the letter and spirit of the Medicare
Modernization Act (``MMA'').
We ask Congress to encourage CMS to this action at the earliest
opportunity to address the access issues that currently exist for
I. Our Commitment to IVIG Access
Talecris Biotherapeutics is a new company that is proud to have
inherited a legacy of more than 60 years of providing lifesaving and
life-enhancing plasma-derived therapeutic proteins. Following its
acquisition of the assets of Bayer Biological Products' plasma
business, Talecris is maintaining and building on a heritage of patient
care innovations in therapeutic proteins that dates back to the early
1940s. Our products have long been recognized in the industry as
innovative and of the highest quality. Talecris, having inherited a
solid foundation of unparalleled expertise and experience, is now
uniquely positioned to create a new standard of excellence in the field
Normal human blood contains antibodies, which help to protect us
from a wide spectrum of pathogens. However, some individuals are unable
to make functional antibodies, which renders them susceptible to
recurrent and life-threatening infections. Treatment with IVIG provides
immune-deficient individuals with the antibodies needed to prevent
potentially fatal infections.
IVIG is produced from plasma pooled from thousands of blood plasma
donors, which is processed to provide a high concentration of
antibodies. Talecris is one of a handful of manufacturers who produce
As you review this issue, we encourage you to be mindful of the
special commitments and efforts that Talecris has made. Talecris has
taken extraordinary steps to substantially improve production of IVIG,
dramatically increase investment in production facilities, ensure the
availability of an emergency supply of product for needy patients, and
conduct important scientific research. Despite the incredible costs
involved in these efforts, we have not, over the last five years,
increased our prices at a rate that has even kept pace with the rate of
inflation. That is an extraordinary commitment to our patients, and we
are justifiably proud of our record.
II. Understanding the Access Issue
The chronology of the development of the IVIG access issue reveals
its substantial link to Medicare reimbursement. Pursuant to the MMA,
the ASP payment system first became the basis of Medicare reimbursement
for services in physicians' offices in January 2005. Reports of IVIG
beneficiary access problems in physicians' offices surfaced shortly
thereafter and were, based on the information that we have received
from patient groups, essentially localized in that site of service.
Significantly, throughout 2005, Medicare continued to reimburse
hospital outpatient facilities without using the ASP methodology, while
Medicare services in the physician office setting were being
transitioned to the ASP methodology. It is important to note that the
patient groups did not report any significant access issues at the time
in the hospital outpatient setting. Indeed, the patient groups reported
a migration of a significant number of patients from the physician
office setting to the hospital outpatient setting.
In January 2006, however, Medicare hospital outpatient
reimbursement did transition to the ASP payment system. Soon after,
patient groups began to report that Medicare beneficiaries were
experiencing IVIG access problems in hospital outpatient departments.
It is important to note that reports of IVIG access issues have been
primarily focused on Medicare beneficiaries, although some commercial
payer coverage changes have been responsible for some additional
Although some appear to be inclined to see the access issues as
supply-driven, and not reimbursement-related, we do not believe that
this is correct, particularly when we examine the evidence related to
our product. Over the last 5 years, we have increased the amount of
IVIG we make available to patients in the United States by 85 percent.
In anticipation of, and in response to, the considerable need for IVIG
over the last decade, Talecris has dedicated significant resources to
meet the needs of the IVIG community. Talecris, for instance, has
invested more than $250 million to build a highly efficient, state-of-
the-art manufacturing facility in Clayton, North Carolina--the only
facility of its size dedicated to IVIG production.
In addition to our dramatic efforts to increase production, we have
established the Gamunex Emergency Supply Program for patients who
might be facing a critically urgent situation related to their IVIG
therapy. As part of our overall commitment to help meet patients'
needs, Talecris holds 2 percent of its inventory in reserve just for
the Emergency Supply Program. Through the program, Gamunex is provided
on a first-come, first-served basis to patients in emergency
situations. We have never come close to exhausting our emergency
supply. This suggests that the nature of the access issues is not
supply, but reimbursement, related.
Further, as noted above, Talecris has approached pricing issues
with restraint and a sincere interest in limiting price increases. Our
price increases have been quite limited despite increased production
costs, significant investments in additional manufacturing capacity,
and large investments in producing a new IVIG product, which we believe
has clinical advantages. Again, since 2000, Talecris has not increased
prices at a rate that keeps pace with the rate of inflation, as
determined by the Consumer Price Index-Urban. To date we have taken
just 15 percent in total price increases over the last 5 years.
We are committed to ensuring access to this life-saving therapy.
Accordingly, we continue to take reports of IVIG access issues
seriously, and we are committed to working openly with the subcommittee
to ensure adequate access to IVIG therapies for the thousands of
Medicare beneficiaries who rely on this important therapy.
III. Proposed Solutions
Talecris is committed to a long-term solution for IVIG access. We
understand how challenging the current market environment is for the
IVIG community, and we plan to continue delivering on our commitment to
do everything possible to meet the needs of IVIG patients. We ask
Congress to urge CMS to do the same by (1) issuing separate HCPCS codes
to IVIG products and (2) increasing the payment for administration
A. Issuing Separate HCPCS Codes to IVIG Different Products
CMS calculates the ASP for drugs based in part on what HCPCS code
those drugs are assigned to using the standardized coding system
utilized for outpatient billing. Each quarter CMS computes an ASP for
each HCPCS code typically based on the volume-weighted average of the
applicable manufacturer's average sales prices. Where there is only one
product in a HCPCS code, which is the case for the vast majority of
drugs, ASP is equal to the price of that product's manufacturer
reported ASP. This system generally makes ASP predictable and the
resulting reimbursement stable and consistent with acquisition prices.
This is, we believe, exactly what Congress intended when it mandated
ASP as a methodology.
Unfortunately, because all of the IVIG products are treated as
multiple source products by CMS, notwithstanding that they are not in
any way bioequivalent, IVIG ASP reimbursement is based on the weighted
average of the ASPs of multiple IVIG products. Accordingly, this
necessarily means that some IVIG products will have reimbursements that
are based on a class ASP that is below the product's actual ASP. The
inevitable consequence of this, we believe, is that there will be
situations where a Medicare provider is forced to provide critically
necessary IVIG services at a reimbursement rate that is below the
provider's acquisition cost.
CMS normally groups only products into one HCPCS code when the
affected products are rated therapeutically equivalent,
pharmaceutically equivalent and bioequivalent by the Food and Drug
Administration (``FDA''). The IVIG products, however, are not
therapeutically equivalent, pharmaceutically equivalent or
bioequivalent, as we have indicated above. There is no debate about
this critical point.
IVIG products differ in terms of the amount of sugar, osmolality,
volume, sucrose, immunoglobulin A, and pH. In addition, products differ
according to donor pools, manufacturing process, and final product
formulation. These differences provide the clinical basis for
physicians to prescribe specific brands of IVIG. When a patient is
administered a brand that is not appropriate for him or her, problems
can arise. This is particularly true for patients with diabetes,
congestive heart failure, and compromised renal function, among other
Fortunately, CMS has the authority to code and reimburse all IVIG
products separately. We believe that this change is integral to solving
the IVIG access issue, and we believe it is entirely consistent with
the ASP methodology. We ask only that IVIG products be treated like the
vast majority of other drugs and the way that any unique, distinct
product should be treated.
B. Increasing the Payment for Administration Services
In addition to the coding problem, we believe that IVIG access is
also compromised due to inadequate reimbursement for administration
services. Where some have suggested that the ASP multiplier should be
increased above 106 percent to address this issue, we do not support
this option, because we do not believe that it is consistent with the
However, the MMA, in decreasing drug reimbursement, did contemplate
that administration service reimbursement could and should be altered
where additional administration reimbursement was shown to be
necessary. We ask that CMS do only what Congress contemplated as part
of its consideration of the MMA. We ask that CMS review the
extraordinary costs inherent in the administration of IVIG and make all
appropriate adjustments that are supported by the evidence presented.
The safe and effective administration of IVIG is extremely complex.
We understand that the infusion times for IVIG range from 2 to 8 hours.
A nurse to patient ratio is set at 1:1, with immediate availability of
a physician for assessment of potential complications. In addition to a
physician's evaluation of a patient, the administration service
includes the complete evaluation of vital signs and neurological status
by a highly trained infusion nurse, pre-medication by an infusion
nurse, and complete assessment of vital signs and neurological status
every 15 minutes. To account for all of these factors, we support an
increase in the payment for administration services.
CMS has the authority to make this increase without Congressional
action. We urge them to act accordingly.
IV. Commitment to Long-term Solution
One of the most important aspects of a solution to the IVIG access
issue is a long-term commitment by Congress and CMS to keep a constant
methodology in place for IVIG reimbursement.
Various factors make a stable market critical to the decision to
invest in increased production. The manufacture of IVIG includes more
than 400 steps from pooling through fractionation, purification,
inspection, and packaging. To ensure additional investment in IVIG
capacity to meet the increasing demand for this life-saving therapy,
predictable demand and long lead times are required because the
manufacture of IVIG takes approximately 8 months from plasma collection
at a donor center to lot release, and purchase commitments for raw
plasma must be made 1-2years in advance. Furthermore, in order to
ensure compliance and regulatory approval, manufacturers must allow up
to 5 years to expand production facilities and modify processes.
Talecris may not continue to make additional investments to
increase IVIG production in an environment where reimbursement is
uncertain or subject to change. We fear that a number of the temporary
or emergency solutions being discussed will only add to
unpredictability of the marketplace, having the unintended result of
discouraging future investments by manufacturers, like Talecris.
We understand that CMS may be contemplating a National Coverage
Determination (``NCD'') restricting the coverage of IVIG. We feel
compelled to call your attention to the significant number of Medicare
beneficiaries who could be negatively impacted by a NCD. We are
concerned that CMS may be attempting to address what are predominately
reimbursement issues by limiting coverage. Unfortunately, because it
would likely take a year or more for an NCD to evaluate the various
uses of IVIG, the inevitable consequence of an NCD will be to interject
tremendous uncertainty into the IVIG marketplace that may prevent
Talecris and other manufacturers from making the additional investments
in production capacity that are so clearly needed.
We appreciate that CMS has some questions about the level of
evidence supporting some uses of IVIG. Accordingly, we support the
further use of the local coverage determination process to address any
such issues, but we believe that these decisions should be made by the
carriers in a manner that will permit local standards of practice to be
fully considered and where the process for review can be quicker than
it could, in connection with this product, through an NCD process. The
local coverage process is the process that has generally determined
IVIG coverage in the past and it should continue to be the process used
in the future.
Many immunocompromised patients rely on this essential therapy to
treat and prevent fatal infections. Accordingly, we ask you to urge CMS
to proceed with caution as it considers coverage issues and to weigh
heavily the long-term implications of restricting the coverage of an
often life-saving therapy in a precipitous manner through a ``one size
fits all'' NCD.
We are sensitive to the complicated nature of the IVIG issue, and
we continue to look forward to the results of the on-going Office of
the Inspector General (``OIG'') study of IVIG access. Talecris was
pleased to meet with the OIG last year and assist with its survey. In
responding to the survey questions, however, it became clear to us that
the study contained a number of design flaws, which may compromise the
results and diminish the OIG's ability to compare data accurately and
ultimately the aggregate value to the information assembled. As the
date of the release of the report is extended, we also have concerns
about whether the data collected is still relevant.
In addition, we have some concerns about the limited scope of the
parties surveyed. We believe that a complete picture of the IVIG
marketplace includes not only manufacturers and distributors, but also
a robust sample of hospital outpatient departments, group purchasing
organizations, physicians, and patient advocates. Broad participation
and comment are key to an accurate report. We have encouraged the OIG
to work with all of the key stakeholders involved, but we do not
believe that OIG has fully adopted our and others' suggestions in this
Talecris thanks you again for this opportunity to provide input to
your review of Medicare reimbursement of physician-administered drugs,
specifically the impact of ASP reimbursement on the pricing and
availability of IVIG therapy. We respectfully ask Congress to urge CMS
to facilitate beneficiary access to IVIG by (1) issuing separate HCPCS
codes to IVIG products and (2) increasing the payment for
administration services. We strongly urge you to consider the lasting
policy implications of Congressional and administrative decisions as
CMS negotiates the delicate balance between appropriate reimbursement
and access to care. We hope that Congress will urge CMS to exercise
restraint in considering any number of policy options that could
negatively impact the long-term sustainability of access to IVIG within
the United States, such as a precipitous NCD process. As the
subcommittee continues to review this issue, we welcome the opportunity
to provide additional information.
July 13, 2006
The Honorable Nancy Johnson
Chair, Subcommittee on Health
Committee on Ways & Means
U.S. House of Representatives
Dear Congresswoman Johnson,
U.S. Oncology is pleased to submit this testimony for the record
for the Committee on Ways & Means Health Subcommittee Hearing scheduled
for July 13, 2006 on Medicare Reimbursement of Physician-Administered
U.S. Oncology, headquartered in Houston, Texas, is one of the
nation's largest community cancer treatment and research networks. U.S.
Oncology provides extensive services and support to its affiliated
cancer care sites to help develop the most advanced treatments and
technologies, build integrated community-based cancer care centers,
improve therapeutic drug management programs and participate in many of
the new cancer-related clinical research studies. The network consists
of nearly 1000 physicians, based at over 450 service sites in 34
states. U.S. Oncology serves as a strong advocate for community-based
cancer care providers, at whose offices approximately 83.4 percent of
all cancer treatment encounters occur in the United States.
Over the past several years, U.S. Oncology and community cancer
care providers have advocated for a balanced and sustainable reform of
the Medicare reimbursement structure for physician-administered drugs
with the goal of preserving and strengthening Medicare beneficiary
access to cancer care services. U.S. Oncology shared the general
concern with the prior system used to pay for chemotherapy drugs and
related drug infusion services: overpayment on drugs was used to
subsidize underpayment on drug administration services.
The Prescription Drug, Improvement and Modernization Act of 2003
(MMA) replaced the flawed system with a new payment structure Congress
intended to more accurately match reimbursement for cancer-fighting
drugs and the delivery of those drugs to the costs of providing those
services. However, in several key areas, the implementation of the MMA
changes to reimbursement of physician-administered drugs has failed to
meet Congressional intent of fair and adequate reimbursement.
Prompt Pay Discount
Prompt pay discounts are discounts typically offered by
pharmaceutical manufacturers to pharmaceutical distributors on direct
sales of prescription drugs. Wholesalers typically do not share
manufacturer's prompt pay discounts with providers. Direct sales by
manufacturers are made to full-service or specialty distributors that
buy in bulk, consolidate orders and make just-in-time deliveries to
providers across broad geographical areas. The prompt pay discount
compensates wholesalers for the time-value of money and the assumption
of credit risk associated with sales to downstream purchasers.
Prompt pay discounts offered to distributors and not passed on to
providers are typically around two (2) percent of the sales price.
According to the Healthcare Distribution Management Association, the
net profit margin for full-service healthcare distributors is about
0.75%. A significant part of a wholesaler's margin comes from
manufacturer to wholesaler prompt pay discounts.
Congress intended under the MMA for ASP to match providers'
acquisition costs. However, CMS has netted a 2% distributor prompt pay
discount out of ASP calculations even though the discount is not
received by providers. As a result, the CMS-computed starting point for
ASP of a drug that costs $100 when purchased by a physician practice is
actually only $98, or 98% of the provider's cost to purchase the drug.
When wholesaler prompt pay discounts are netted out of ASP, Part B
reimbursement to physicians and pharmacies is effectively reduced by 2%
to provider cost+4%.
In recognition of the role that prompt pay discounts play in
wholesaler compensation, Congress excluded customary prompt pay
discounts extended to wholesalers when it redefined Average
Manufacturer Price (AMP) under the Deficit Reduction Act of FY 2006.
The redefined AMP will be used by the Medicaid program as a metric both
for retail pharmacy reimbursement and Medicaid rebate calculations.
U.S. Oncology strongly urges Congress to apply the same formula to
the Average Sales Price (ASP) metric used to compensate physicians and
pharmacies for drugs reimbursed by Medicare Part B as physicians and
pharmacies cannot buy these drugs at prices net of customary wholesaler
prompt pay discounts. Removing customary prompt pay discounts to
wholesalers from the ASP calculation under Medicare Part B would:
1. Make ASP more reflective of pricing actually available in the
marketplace to the physicians and pharmacies that buy and administer or
dispense Part B drugs;
2. Better align manufacturer's calculation methodologies for ASP
and AMP, thus simplifying manufacturers' price reporting burden; and
3. Ensure consistency in the way prompt pay discounts are handled
in the calculation of the reimbursement metrics that determine
government payments to pharmacies that dispense outpatient drugs
regardless of whether Medicaid or Medicare Part B is the government
Removing customary prompt pay discounts to wholesalers from the ASP
calculation under Medicare Part B would better reflect the
Congressional intent behind the ASP payment methodology. As noted
above, a key objective of MMA was to match reimbursement for Part B
drugs with the drugs' actual acquisition costs in the market.
Subtracting customary wholesaler prompt pay discounts when ASP is
calculated artificially distances reimbursement from cost and is
inconsistent with the Congress' intent to ensure patient access to
higher cost drugs in hard-to-serve areas.
Currently, there is a six-month, or two-quarter, lag between
manufacturer reporting and updating of ASP for physician reimbursement
under Medicare Part B. The practical implication of this two-quarter
lag is that a provider's drug cost increase experienced today will not
be recognized by CMS for six months.
Approximately 90% of oncology drug expenditures are made for single
source drugs, which leaves manufacturers little incentive to reduce
drug prices over time. For some commonly prescribed and expensive,
single source cancer drugs and certain other injected or infused
products that are standard of care, ASP has been rising rapidly,
frequently on a quarterly basis. Examples include 4.3% and 2.6%
increases in Aloxi and Eloxatin ASP values, respectively, between 2q06
The two-quarter lag means the effective payment for drugs with
rapidly rising prices can be below current acquisition cost, not
ASP+6%, exclusive of the prompt pay discount reduction and other
issues. The reverse is true when prices are falling, as can happen when
an innovator drug comes off patent.
U.S. Oncology believes that in a rapidly changing market, reducing
the lag time between the reporting and use of ASP would better align
reimbursement with physician acquisition costs. We urge the Committee
to work with the cancer care community to develop a system that ties
physician reimbursement to monthly ASP reports as opposed to quarterly
ASP reports. Manufacturers must begin reporting AMP monthly as of Jan.
1, 2007 under the DRA. Simultaneously requiring monthly ASP reporting
beginning Jan. 1, 2007 could effectively reduce the lag between ASP
reports and physician payments by 2-3 months beginning in the third
quarter of 2007.
If the lag time were materially reduced, providers would experience
fewer cash flow dislocations due to rising ASP. For the same reasons,
Medicare would benefit more quickly when prices are falling.
Medicare Bad Debt
When taken in combination, netting out wholesaler prompt pay
discounts and the two-quarter lag result in effective reimbursement for
physicians of provider cost plus 2% assuming all allowable costs can be
collected by the provider. Our historical experience has been that
approximately 25% of Medicare's 20% patient co-insurance is
uncollectible bad debt. Medicare bad debt results in an additional loss
equating to approximately 5% of Medicare allowable costs and drives the
actual reimbursement received by community cancer care providers for
drugs provided to Medicare beneficiaries down to three percent below
provider cost on average.
The Medicare bad debt faced by community cancer care providers is
primarily attributable to uncollectible patient co-insurance of
Medicare beneficiaries who cannot afford or choose not to purchase
secondary insurance. With the patient co-insurance portion of many drug
regimens costing thousands of dollars, a large portion of Medicare
beneficiaries without secondary insurance will never be able to pay any
more than a trivial portion of their co-insurance. As the Committee
considers the effects of the Prompt Pay Discount and the Two Quarter
Lag discussed above, it is important to recognize the reality that
Medicare makes no provision for the bad debt experienced by community
cancer care providers. This reality will continue to negatively impact
patient access to quality care.
Adopting and adjusting these provisions would lead to a
reimbursement that would be more consistent with the 6% of ASP cushion
Congress intended to ensure patient access and protect rural physicians
from underpayments because reimbursement based on monthly ASPs would
reflect more current pricing.
Drug Administration Services
U.S. Oncology does not believe that drug reimbursement and the
transition to an ASP-based reimbursement structure are properly viewed
in the absence of a discussion of reimbursement for the administration
of the same drugs to Medicare beneficiaries. U.S. Oncology remains
extremely concerned about the underpayment of drug administration
services under both the current and proposed Physician Fee Schedule
Practice Expense methodologies.
MMA established a framework and direction to CMS to fully cover
drug administration practice expenses that were previously covered
through drug product payments. Congress recognized the inadequate drug
administration payment system by creating drug administration
transition payments (32% add-on in 2004 and 3% add-on in 2005) to allow
CMS time to build in these new payments into the practice expense
Additionally, Congress created a budget neutrality waiver for CMS,
extending through 2006, to ensure that these new practice expense
reimbursements necessary to cover the costs of drug administration
would not adversely impact other specialties.
Despite clear intent of Congress through MMA to more accurately
match practice drug acquisition and drug administration reimbursement
with the costs of providing those services, our practices have
experienced practice expense reimbursements that have declined by 20%
since 2004 and CMS recently proposed a new Practice Expense methodology
that will further exacerbate the under funding of drug administration
services in 2007 and beyond.
Medicare currently reimburses less than 60% of practice drug
administration costs even for the mythical provider who collects 100%
of the patient co-insurance. U.S. Oncology's analysis indicates that
community cancer care providers are paid more than $900 below the cost
of drug administration for each Medicare beneficiary and this
underpayment rises to nearly $1000 below cost net of bad debt.
Please see Exhibit A--U.S. Oncology Comments Regarding Practice
Expense Methodology Submitted to CMS March 28, 2006--for further detail
relating to continuing underpayment of drug administration services.
Competitive Acquisition Program (CAP)
In December of 2005, U.S. Oncology informed CMS that it would not
participate as a vendor in the Competitive Acquisition Program (CAP)
due to continuing concerns about the potential negative impact the
program may have on the ability of the cancer care community to deliver
high-quality cancer care services to patients in a safe and cost-
effective manner. Subsequent developments have strengthened our belief
that CAP is fatally flawed for both vendor and physician and does not
constitute a realistic or viable alternative to the reimbursement
challenges facing community cancer care providers.
Please see Exhibit B--U.S. Oncology Comments Regarding the
Competitive Acquisition Program (CAP) Submitted to CMS December 22,
2005--for further detail relating to problems with CAP.
Thank you for the opportunity to provide this written testimony for
inclusion in the Committee Record. U.S. Oncology looks forward to
working with the Committee to construct an adequate and sustainable
reimbursement system that appropriately values the needed and life-
saving services provided to Medicare beneficiaries by the cancer care
Senior Vice President
West Michigan Regional Cancer and Blood Center
Free Soil, Michigan 49411
July 18, 2006
I would like to add my comments to The Ways & Means Health
Subcommittee on the subject of Medicare Reimbursement for Physician
Administered Drugs. As a medical oncologist practicing in a community
cancer center in rural northern Michigan, I have experienced firsthand
the devastating effects caused by the change in the formula for
calculating Medicare reimbursement for treatment provided at our cancer
Currently, of the 61 drugs that we routinely use, our profit margin
on 38 of them is less than 6%, which was not the premise of the ASP+6%
calculation. Additionally, because we are located in a rural area, our
surrounding community hospitals are small and refuse to treat our
patients at their facilities, citing that their staffs are untrained in
oncology administration and that the cost of providing oncology
services would cause an unsustainable financial burden.
Because of these issues, there are drugs that I must discontinue
using in my practice, due to the severe negative financial impact.
Sandostatin, for example, which is approved by Medicare for
chemotherapy-induced diarrhea, costs me $2603.09 per dose. We bill
Medicare and four weeks later receive 80% of the ASP+6%, which amounts
to $2082.47. Until we receive the co-pay from the patient, or from
their supplemental insurance, we are ``underwater'' by $520.62.
Another example is the use of Rituxan, a monoclonal antibody
routinely used to treat and cure lymphoma. The average dose of Rituxan
costs me $3726.00 and I get reimbursed 80% of the ASP+6%, which is
$2980.00 per dose. Again, I carry the financial burden of the 20%
($746) while waiting for secondary insurance or patient payment. It
doesn't take long for these underpayments to add up and cripple my
The true absurdity of the situation is that while these drugs can
reduce hospital admissions, morbidity and mortality rates, I am forced
to use alternatives for these drugs, even when they are suboptimal.
Ultimately, the patient suffers and Medicare often pays more due to
hospital admission and extended illness.
The above examples are just two of the 38 drugs that are not
adequately reimbursed by Medicare. Changes must be made to compensate
for this deficit in reimbursement for drugs, whether it is increasing
chemotherapy administration payment or providing reimbursement for the
other costs of administering treatment.
There are many costs related to providing chemotherapy services
that are not compensated, for example pharmacy costs, which include
procurement of the drugs, secure storage and inventory control,
treatment preparation, and pharmaceutical spoilage or wastage.
I trust that you understand the ramifications these reimbursement
reductions have on our patients, your constituents, and that you will
move swiftly to correct these inadequacies.
Thank you for your attention to this important issue. If I can be
of further service and provide additional information from a rural
cancer center perspective, please do not hesitate to contact me.
A. Soliman Behairy, MD
Western Washington Medical Group
Departments of Hematology & Medical Oncology
July 17, 2006
I would like to take this time to explain how very difficult it is
becoming for our office to provide good quality cancer care to our
Medicare/Medicaid patients. Due to the ASP methodology, in the second
quarter of 2006, I was buying 12 drugs for more than CMS allows for
reimbursement. I do not have a concise total as of yet for the third
quarter because I am still getting many price increases from
pharmaceutical companies, but I assume it will be similar. In order to
obtain the best pricing I can, I pay for our drugs through direct debit
the day I receive them, causing a financial hardship to our practice
when we have not yet had time to be reimbursed for those drugs. I also
shop around to find the best prices through a variety of oncology
specific vendors, of which I might add, takes too much of my time. On
other drugs, we might get reimbursed $.01 more than we pay, so as you
can see, we are certainly not covered for our cost of storage or for
We are not adequately reimbursed for the special space we are
required to have in our office to safely store and mix these toxic
drugs or for the specialized personnel it takes to administer these
We have had to resort to sending some patients to the hospital for
treatment and have not found this very optimal as we find the hospital
personnel are not as proactive in assuring the patient has all that
they need in the way of take home drugs and/or prescriptions necessary
in the event they should have some common side effects.
Due to Part D, those patients that are in a low income level, that
qualified for assistance through the pharmaceutical companies for their
oral agent treatments, are no longer eligible and consequently some
have chosen not to be treated.
In all, we feel we are working harder and taking more financial
risk to care for this group of patients and are reimbursed less, to the
point of jeopardizing our practice, of which 45% is Medicare and 5% is
Medicaid. Especially when you consider that some commercial payors are
trying to emulate the ASP system.
We have considered CAP, but in analyzing all that would be entailed
in that program, we found it to be even less of an option.
These physicians, as I am sure is true of most Oncologists, became
Oncologists in order to help these patients who are fighting for their
lives, but today they find themselves having to weigh the financial
reality of caring for these very patients.
We sincerely hope that you will find some way to alleviate the
hardship MMA has put upon us as well as our patients and rectify these
Community Oncology Alliance
July 17, 2006
The Honorable Nancy Johnson
Chairwoman, House Ways and Means Subcommittee on Health
U.S. House of Representatives
2113 Rayburn HOB
Washington, D.C. 20515-0521
Dear Madam Chairman:
For the record, I am submitting this written testimony on behalf of
the Community Oncology Alliance (COA) and to supplement my testimony
before the Ways and Means Subcommittee on Health at the hearing on July
I would like to clarify my misunderstanding and incorrect answer
relating to a question you asked me concerning CMS using oncology data.
For the record, from the official transcript just released you
asked the following question:
REP. JOHNSON: How do you respond to CMS's comment that they used
your survey data and your survey data included the cost of pharmacy?
To this question, I responded:
DR. SCHNELL: We have sent them our data and have--effectively
approximately three months ago and have had no response. I gather
that's not an isolated experience after sitting through this.
Unfortunately, I was referring to analyses that we supplied to CMS
relating to the coding of certain cancer treatment regimens, which show
that on the treatment level services reimbursement has decreased from
2004 to 2006. What I did not understand is that you were asking me if
it is correct if CMS used oncology survey data, specifically in
capturing the cost of pharmacy-related expenses.
Yes, in a manner that we cannot determine, CMS has used 2001 data
provided in 2002 by the American Society of Clinical Oncology (ASCO).
Unfortunately, we have maintained to both ASCO and CMS that this data
was fundamentally flawed and is now outdated. In summary,
data was collected at the oncologist level (and only from
oncologists who were ``full or part owners'' of their medical practice)
not at the practice level, thus making it virtually impossible to
accurately capture all practice/clinic expenses;
only 8 data elements (i.e., practice expense dollar
amounts) were collected (see Exhibit A in the enclosed document) making
it impossible to attribute expenses to specific services such as
treatment planning and pharmacy facilities;
much of the data, including high dollar expense items,
were seemingly arbitrarily discarded by CMS, thus decreasing total
practice expenses attributed to oncology; and
the practice expense data from 2001 is now obsolete,
especially given treatment advances and reimbursement changes over the
past 5 years, which have increased expenses.
We have attached a brief background piece on this that provides
more detailed information on why ``the oncologists' own data'' is not
valid and reflective of actual community oncology practice.
We suggest that it would be very helpful if CMS could provide
information on ``unbundling'' some of the most frequently used drug
administration codes. Let me explain. We constantly hear the argument
that all expenses for essential services we provide are ``bundled''
together and therefore paid under the most common billing codes we use.
However, we are not able to obtain a breakdown, or ``unbundling,'' for
these codes from CMS. We would appreciate help in obtaining this
information from CMS. This will then allow us to compare these
component expenses, and the corresponding ``unbundled'' reimbursement,
with actual practice costs.
Regardless of this ``bundling'' issue, in the spirit of paying
appropriately for drugs and specific services, we believe that there
should be separate payment codes for drug administration, treatment
planning, and pharmacy facilities, in addition to the evaluation and
management (E&M) codes used by all medical specialties. CMS could
easily accomplish this administratively, as we believed this was
supposed to happen per the Medicare Modernization Act of 2003.
I trust that this clarifies my response to your questions.
Frederick M. Schnell, MD, FACP
Analysis of the ASCO/Gallup/Lewin Oncology Survey Data Used by CMS
Prepared for Congresswoman Nancy Johnson
Data was collected by the Gallup Organization on behalf of the
American Society of Clinical Oncology (ASCO), submitted to CMS, and
analyzed by the Lewin Group. This is ``the oncologists' own data'' that
CMS references as being used in justifying the current level of
reimbursement for all services provided by community oncologists. There
are fundamental flaws with the way the data was collected, the way it
was analyzed, and the conclusions drawn from it. The specific problems
are summarized as follows:
Data was collected at the individual oncologist level and
not at the medical practice level; that is, the data could only be
submitted for full--or part-time physician owners of the practice as
opposed to all other physicians, nurse practitioners, oncology nurses,
and staff that composed the entire community oncology clinic. Given the
comprehensive nature of community oncology clinics, even the smallest
clinics, it is extremely difficult, if not impossible to attribute
expenses to an individual oncologist. This approach will result in
artificially lower practice expenses.
The actual practice expense data captured is attached as
Exhibit A. Only 8 practice expense dollar amounts were collected via
phone survey. This made it impossible to value any costs relating to
specific functions such as treatment planning and pharmacy facilities.
At best, the data could be used in a collective manner to attribute
some practice expense component to the drug administration codes.
The calculation of hours Lewin made about the time
oncologists spend in direct patient care is inordinately high. This
resulted in lower expenses attributed per hour (because the hour
denominator was artificially high) and, therefore, resulted in lower
total practice expenses.
It is impossible to ascertain if the final data accepted
by CMS is representative of actual community oncology. Lewin even
questions the representative nature of the sample given the low survey
response rate. Furthermore, it appears that data outliers were
arbitrarily excluded from the final data accepted.
There was great concern expressed by CMS over high
``clerical'' salaries. The data and cost from larger practices that
employ more highly compensated administrators, CEOs, CFOs, etc., were
therefore excluded from the survey thus giving an unfair representation
of salary cost across the board from smaller to larger clinics.
The data used is from 2001 and is therefore obsolete.
This information is prior to the availability of newer treatment
protocols and changes to Medicare reimbursement for cancer care.
What follows are specific facts and problems associated with this
data being used in any way by CMS to draw accurate conclusions about
appropriate levels of services reimbursement.
The Gallup Organization, which was contracted by ASCO to collect
community oncology practice expense data, started with the AMA
MasterFile of 5,574 oncologists. Out of the 5,574, Gallup attempted to
contact 2,356 oncologists. Out of the 2,356, there were 999 responses
collected by Gallup and submitted to CMS. The Lewin Group, which was
contracted by CMS to analyze the data (see Recommendations Regarding
Supplemental Practice Expense Data Submitted for 2003, Centers for
Medicare and Medicaid Services, #500-95-0059/TO#6, September 17, 2002)
eliminated 416 responses because these were responses from oncologists
that were not owners of their practice. CMS edits eliminated an
additional 338 responses leaving a usable sample of only 245 physician
The AMA MasterFile clearly does not include all of the
office-based oncologists in the United States. There is no way of
knowing how representative the AMA MasterFile is in terms of office-
based community oncology practice. With the elimination of data, there
is no way of knowing how representative the 245 physician responses are
of nationwide community oncology practice.
Lewin questioned if the final sample was indeed
representative (``This low response rate may indicate that the
responses are not representative of the population of oncologists.'').
The 245 responses represent individual physicians, not
necessarily individual practices. We know of instances where two or
more physician owners from the same practice submitted data.
The survey was at the physician level, not at the practice level.
Only individual oncologists who are owners of their practice were
eligible to submit data for their ``share'' of practice expenses.
Oncologists who are not owners were excluded from the survey. The
survey requested only 8 data elements of practice expenses (see Exhibit
There are numerous problems associated with determining
the oncologist's ``share'' of practice expenses, especially specific to
the oncologist who is a partial and/or full ``owner'' of the practice.
Is the ``share'' what the oncologist is legally liable for as a
shareholder or is his/her ``share'' the amount of expense attributable
to his/her particular practice from an accounting standpoint? We polled
clinic practice administrators who responded to the survey and the
interpretation varies. It is virtually impossible to assume that the
data was consistent and representative of total practice expenses.
No data were collected relating to specific functions
performed by the oncologists, nurses, or staff or to specific
components of overhead. Therefore, it is impossible to draw any
conclusions about expenses attributed to such specific components of
care such as treatment planning or pharmacy facilities.
CMS disputed and originally rejected the ASCO data as too high
because the salaries reported for ``clerical'' personnel were
calculated as being higher than that for ``clinical'' personnel. Lewin
reports that the average clerical person makes $87,253 per year and the
average clinical person makes $71,014 per year. Lewin questions the
accuracy of the abnormally high clerical salaries.
In the data collected, there was only one question
pertaining to the salaries of ``administrative, secretarial, or
clerical'' personnel. Yet, because community oncology practices
function more as clinics than simple physician offices, they typically
have more experienced practice administrators and related staff (CEOs,
COOs, CFOs, etc.). It appears that either data was eliminated or
adjusted, thus artificially lowering overall practice expenses.