Update October 28, 2001: Gregory sent the article below to replace his previously posted article, "Brain Radiation From Whole Brain Radiation Therapy". Steered by medical professionals to also research the Cocktail Chemotherapy causes of his wife's death, Gregory said he was "absolutely shocked by what he discovered" and consequently wrote this new article to cover both subjects.
Update Nov 2003:
My wife had been diagnosed with
Ovarian cancer in 1972 when she presented with a left DVT (deep vein
thrombosis) and pulmonary embolism. Workup which was triggered by this
presentation revealed that she did have an ovarian carcinoma for which she
underwent total abdominal hysterectomy and received Chlorambucil(Leukeran)
treatment. The postoperative chemotherapy drug she received was in no way
as toxic as the ones given today. She was also given very limited amounts
over a long period of time to allow the immune system to regenerate and
contribute to healing. She went twenty-four years before she ever had a
metastatic ovarian recurrence.
Metastasis are cancer cells that travel to other parts of the human
body from a primary cancer site and develop into a lesion (tumor). Her
first metastatic recurrence was a transdiaphragmatic tumor from the
original primary ovarian tumor with attachment to the lung and other
midline structures of the chest. It was surgically resected at Fox Chase
Cancer Center in August 1996. The Thoracic Surgical Oncologist was 100%
successful and felt my wife did not need any treatment with chemotherapy.
Some primary cancers like Breast and Lung can commonly metastisize to
the (CNS) Central Nervous System, like the brain. However, it is very rare
for Ovarian cancer cells to metastisize into the Central Nervous System.
In fact, up until 1994 there have been only 67 well documented cases in
medical literature. A multi-institutional study of 4027 Ovarian cancer
patients over 30 years identified only 32 cases while an autopsy study of
Ovarian cancer reported an incidence of 0.9%. Metastasis of Ovarian cancer
to the central nervous system is uncommon and was rarely seen before the
use of present day chemotherapy regimens.
How do Ovarian cancer cells invade the Central Nervous System? Cocktail
Chemotherapy. It can do this in two ways. Some chemotherapy drugs do
permeate (pass through) the blood-brain barrier (the system that protects
the brain from foreign substances by blocking their passage from the
blood). Unfortunately, some chemotherapeutic agents weaken the blood-brain
barrier (BBB) transiently and allow CNS seeding. In essence, it breaks
down, damages the blood-brain barrier to invite cancer cells into the
Central Nervous System. In recent years the incidence of CNS (Central
Nervous System) metastasis has increased. A NCI study in 1995 reported
experience in their clinic where recurrent systemic disease occurred in
all patients for which they received dose intense paclitaxel (taxol)
therapy. Brain metastasis was the only site of disease recurrence. The
cerebellum was involved in two out of three patients, presenting with
headache, dizziness, unsteady gait, nausea and vomiting (all symptoms and
results my wife experienced).
The second way cancer cells invade the Central Nervous System is that
Chemotherapy suppresses the body's immune system. The body's immune system
attacks and eliminates not only bacteria and other foreign substances but
also cancer cells. Cancer cells are not foreign to the body but their
biological function has been altered in that it doesn't respond to the
body's normal mechanisms for controlling cell growth and reproduction
(uncontrolled cell growth and reproduction is what causes cancerous
tumors). Much of the body's protection against cancer is carried out
directly by cells of the immune system rather than by antibodies
circulating in the bloodstream. Cancer is 100 times more likely to occur
in people who take drugs, like chemotherapy that suppress the immune
system than in people with a normal immune system.
My wife received postoperative Chemotherapy at the Reading Hospital
& Medical Center, seven months after having that metastatic tumor
resected. She did not have any cancer tumor markers indicate any cancer
within her system when she received the chemotherapy treatment (she did
not have any cancer). Some tumors send out microscopic outposts while
others do not. However, doctors cannot tell which ones do, so they give
chemotherapy in nearly every case. The hit fast, hit hard type of
Chemotherapy she received was a highly neurotoxic cocktail of Taxol and
Carboplatin. A group of platinum based drugs called Cisplatin, Cisplatinum
and Carboplatin and a natural substance called Taxol, cross the blood
brain barrier. She developed necrotizing leukoencephalopathy (a form of
diffuse white matter injury that can follow this chemotherapy), confirmed
by an enhanced MRI in July of 1998. The white matter is the covering of
the nerves within the brain. Its function is to speed up the passage of
impulses along the nerves. Necrosis is simply a cell dying, all of its
coordinated activities going wrong and things shut down. If a cell gets
too much heat or is poisoned by a toxic substance or exposed to chemicals
that damage its proteins and membranes or radiation that breaks its DNA
molecules, that cell can just stop functioning. The effects of
leukencephalopathy can be very severe, including mental confusion, fits
and paralysis.
During the Summer of 1998 a solitary cerebellar brain metastasis was
found via enhanced Cat Scan and confirmed by an enhanced MRI. The 3.5cm
tumor was resected in July 1998 at the Hershey Medical Center. Histologic
features were consistent with metastatic papillary adenocarcinoma with
"extensive necrosis" from the ovary. Necrosis means dead. Necrotic tissue
means dead tissue. Tumors are not dead, they are uncontrolled cell growth
and rapid reproduction. Imaging features of necrotizing
leukoencephalopathy include periventricular white matter hypodensity on
Cat Scan and hypo/hyperintensity on T1/T2 weighted MRI. Postoperative
Chemotherapy treatment of Taxol and Carboplatin was not the proper
treatment for her. She did not have any cancer at the time of
treatment. The analogy of millions and millions of microscopic cancer
cells (not being able to be seen), becoming billions and billions of
cancer cells and eventually becoming a tumor, medical oncologists cannot
tell. So, chemotherapy is given after surgery just in case tumors would
occur. This does promote chemotherapy!
My wife received postoperative Whole Brain Radiation therapy for that
large solitary brain metastasis at the Reading Hospital & Medical
Center. She began developing brain radiation necrosis within 6-10 months
after Whole Brain Radiation, confirmed by an enhanced MRI in June of 1999.
Her radiation-induced brain necrosis could have been focal or diffuse,
depending on the modality of treatment. The five fractions of focal
radiation to the local tumor bed that she received could have resulted in
focal necrosis around the tumor bed or she could have developed metastatic
recurrence. Her additional twenty fractions of Whole Brain Radiation
resulted in diffuse necrotic effects.
An EEG of December 1999 showed generalized diffuse slowing that was
significant with global encephalopathy. It is most commonly seen in toxic
metabolic and degenerative conditions (my wife received five of six
intended treatments of the highly neurotoxic chemo cocktails of Taxol and
Carboplatin from March until July of 1997). There appeared to be a real
amount of focal right sided slowing which would indicate cortical
dysfunction on that side.
A number of MRI's showed the ventricles overall were prominent and
there was widening of the sulci consistent with atropy. There was diffuse,
abnormal signal intensity within the periventricular white matter,
consistent with post radiation changes. The signal abnormality within the
white matter appeared slightly increased compared to her prior studies.
A Pet Scan in August 2000 showed globally decreased radiotracer uptake
within the brain, bilaterally, consistent with involutional change and
prior radiation therapy.
Delayed radiation injuries result in increased tissue pressure from
edema, vascular injury leading to infarction, damage to endothelial cells
and fibrinoid necrosis of small arteries and arterioles (my wife suffered
a stroke to the left basal ganlia area of the brain in January 2000,
confirmed by an enhanced MRI).
There are a number of radiation treatments for therapy (Stereotatic,
Gamma-Knife & Brachyradiation to name a few). The Whole Brain
Radiation treatment my wife received was not the proper treatment for her.
In her case, tumors greater than 2cm in size should be resected (if
possible) and depending on the surgeon's success (her's was 99%) focal
radiation to the local tumor bed is indicated. Her radiation oncologist's
ideas were different from those of the neurosurgeon and gave her twenty
fractions of Whole Brain Radiation to a perfectly good brain.
The radiation oncologist had not told us of any of the late-delayed
reactions that could happen from Whole Brain Radiation (the Pennsylvania
State Board of Medicine and the Department of Health are presently
investigating my wife's case). Aggressive treatment (like surgical
resection and focal radiation to the local tumor bed) in patients with
limited or no systemic disease can yield long-term survival. In such
patients, delayed deleterious side effects of whole brain radiation
therapy are particularly tragic. Within 6 months to 2 years patients can
develop progressive dementia, ataxia and urinary incontinence causing
severe disability and in some, death (all symtoms my wife developed).
A recurrence of the cerebral metastasis was very likely to happen in
the future. It did, observed via an Enhanced MRI of May 2000 and that Pet
Scan of August 2000. Four, mm-sized metastatic tumors were found in and
around the previously resected cerebeller tumor and because of Ann's
weakened condition, Gamma-Knife would be the only best medical course of
success. She received Gamma-Knife treatment at University of Maryland
Medical Center on September 12, 2000. During the whole time of her
admission at the hospital, the doctors kept referring to her continued
diffuse white-matter injury (Radiation Necrosis), as if she was too far
advanced in that injury to survive much longer.
My wife died on September 21, 2000 at the age of 68 from
Cardio-Pulmonary Failure. Minutes before she expired, her temperature was
normal, her blood pressure was normal but her pulse was 150 (tachycardia).
Her heart was racing to keep up with the lack of brain function and
finally quit. The white matter disease that Ann experienced and caused her
death was primarily a result of Whole Brain Radiation and secondary a
result of Cocktail Chemotherapy of Taxol & Carboplatin.
I never came across the idea of radiation necrosis, much less
chemo-induced necrosis, until the doctors at Hershey Medical Center
pointed it out to me in June 1999. I've spent two years with many a
sleepless night researching what really happened to my wife and how she
was killed. Death by "side effects of treatment" is not the same as
"complications of cancer". A lot of cancer patients who succumb to their
disease, get the wrong information on their death certificates. They die
with incorrect, incomplete or misleading diagnoses. Often it will say they
died of heart failure, kidney failure, liver failure, etc. These can be
side effects of cancer treatment as well as the progression of the cancer.
They are lumped together reducing the general understanding of the impact
of cancer. We need to reinvent the death certificate, rewritten to include
things like death from side effects of treatment, death from advanced age,
etc. with more information so we can figure out trends and what
contributed to the death.
The sad idea I found out over my two years of research was that cancer
patients do die from chemo-radiation treatments. The very sad idea I found
out that this is the "norm", a common occurrence. I just can't believe
this and refuse to accept this adage. Yes, I'm bitter and angered, so was
my wife. She wanted me to put my anger and bitterness into constructive
research, education and exposure of the conventional way patients are
being treated for cancer. So much conventional cancer treatments have been
available for such a short period of time that it has not yet been
determined all of the truely long term side effects of some of these
treatments. One can learn from someone else's mistakes or one can learn
from their own mistakes. They have a choice.
I am a spouse who saw his soul-mate being slowly tortured to death
because of what he did not know before but who knows now, the insidious
side effects they incurred on my wife with negligent practice. I never
realized a patient or patient's loved one had to be just as knowledgeable
or even more knowledgeable than the oncologists that treat these patients.
Not having the knowledge beforehand resulted in the death of my loved one.
Her death was chemo-radiation necrosis, a slow, arduous, neurological
death. It is not preferable to a cancerous death.
Gregory D. Pawelski return to HealthRead
Then there was another major New York Times article by Reed Abelson,
back in January of 2003 that brought it to my attention again. I sent
a copy of that article to Dr. Larry Weisenthal of the Human Tumor
Assay Journal. I found out that he first raised this issue of conflict
of interest (i.e. oncologists having a financial incentive to select
certain forms of chemotherapy over others because they received higher
reimbursement) in official, recorded testimony at a Medicare Executive
Committee meeting in Baltimore in March, 2000. He was one of the very
first medical oncologists in America to expose this and advocate its
change. This issue addressed one of my biggest concerns about my
wife's cancer care by my local community hospital. Each and everytime I think why our local community oncologists
coerced my wife into receiving chemotherapy seven months after the
surgeon at Fox Chase Cancer Center specifically stated that further
treatment with chemotherapy was "not" indicated, I just have to
remember the "Chemotherapy Drug Concession". This was the "beginning" of her demise! I began posting the information on as many web sites that I visit
on the internet, to see that it got some needed public scrutiny. I
even got a call from a CBS producer who was doing a story on it and
saw all my information on the internet. I got her in touch with Dr.
Weisenthal. It apparently it was receiving some public scrutiny. Centers for
Medicare & Medicaid Services (CMS) was going to force steep reductions
in Medicare drug reimbursement to oncologists for chemotherapy
infusion procedures. That triggered Congress to act with pressure from
cancer doctors. What resulted was the introduction of H.R. 1622 by
Representatives Charlie Norwood of Georgia and Lois Capps of
California, The Quality Cancer Care Preservation Act of 2003. It would
increase Medicare reimbursement for practice expenses while
reimbursing chemotherapy drugs at rates closer to cost. The concept of creating a system which rewards doctors for giving
chemotherapy, and doesn't reward them for spending a half hour talking
to a patient to explain why chemotherapy won't help is a bad system.
But money will always corrupt. And the chemotherapy reimbursement
system was corrupting. If it's finally going to go -- good riddance. Drug Sales Bring Huge Profits, and
Scrutiny, to Cancer Doctors Medicare law provision would trim drug
profits Summary of H.R. 1622
500 F Lambda Circle
Wernersville, PA 19565
Email: gdpawel@attglobal.net
Permission for you to copy and use material in full is
granted by the author, Gregory D. Pawelski.
Each and everytime I think why our local community oncologist gave my
wife the heavy neurotoxic combination of taxol/carboplatin, instead of
the previous first-line chemotheropeutic agent she received for the
orginal cancer in 1972, I just have to remember the "Chemotherapy Drug
Concession".
I drink a toast, in honor of my deceased wife and a hundred thousand
other cancer patients, when it's finally gone!
By REED ABELSON (New York Times)
Among cancer doctors, it is called the chemotherapy concession. At a
time when overall spending on prescription drugs is soaring, cancer
specialists are pocketing hundreds of millions of dollars each year by
selling drugs to patients - a practice that almost no other doctors
follow.
The cancer specialists can make huge sums - often the majority of
their practice revenue - from the difference between what they pay for
the drugs and what they charge insurers and government programs. But
some private health insurers are now studying ways to reduce these
profits, and the issue is getting close attention in Congress.
Typically, doctors give patients prescriptions for drugs that are then
filled at pharmacies. But cancer doctors, known as oncologists, buy
the chemotherapy drugs themselves, often at prices discounted by drug
manufacturers trying to sell more of their products, and then
administer them intravenously to patients in their offices.
The practice also creates a potential conflict of interest for these
doctors, who must help patients decide whether to undergo or continue
chemotherapy if it is not proving to be effective, and which drugs to
use.
Cancer specialists have successfully resisted most government efforts
to take the drug concession away, arguing that they need the payments
to offset high costs in the rest of their practices. An attempt by the
Clinton administration to change reimbursement practices was strongly
opposed by doctors, and by George W. Bush, who was then governor of
Texas, among others. But support for change is growing, and some
changes are beginning to take place.
"This has gotten out of hand," said Dr. William C. Popik, the chief
medical officer for Aetna which is exploring different approaches to
the concession, including taking it away in some regions.
Health insurers say they can buy these drugs much less expensively
themselves and have the drugs shipped directly to doctors' offices.
Some also want to keep better track of how the drugs are used.
Critics say the money these doctors make from selling medicine is
contributing to the nation's high health care bills and adding to the
waste and inefficiency in the health care system.
Medicare, which does not cover most prescription drugs, does pay
doctors about $6.5 billion a year for drugs they personally
administer, largely cancer drugs. Under the current system of
determining what the appropriate prices for these drugs are, the
government is paying, by some estimates, more than $1 billion over
what the drugs actually cost. Many private insurers say they are also
overpaying for these drugs.
In some cases, patients may even be paying a much larger co-payment
for the drug than a cancer doctor is paying to buy it. Some patients
paid about $150 out of pocket for Toposar, a cancer drug, for example,
while doctors appear to have paid closer to $60 after various
discounts from Pharmacia the manufacturer, according to the Minnesota
attorney general, who is suing Pharmacia, accusing it of pricing
fraud.
The General Accounting Office, which studied federal payments for
cancer drugs in late 2001, discovered that doctors, on average, were
able to get discounts as high as 86 percent on some drugs. Doctors
paid less than $3 for a single dose of leucovorin, for example, while
patients paid them around $3.50 out of a total reimbursement of about
$17.50.
"We think it's a bad system that creates bad incentives that creates
bad medicine," said Robert M. Hayes, president of the Medicare Rights
Center, a consumer group, who testified before Congress last fall on
the issue.
Dr. Thomas J. Smith, an associate professor of oncology at the Medical
College of Virginia Commonwealth University, has estimated that
oncologists in private practice typically make two-thirds of their
practice revenue from the chemotherapy concession.
The concession echoes the system in Japan, where doctors make money by
dispensing drugs. Drug spending per capita in Japan is among the
highest in the world, higher than in the United States.
"This is our little corner of Japan," said Joseph P. Newhouse, a
health policy professor at Harvard, who has been asked by the
government to look into how the Medicare reimbursement system may
affect how doctors prescribe chemotherapy.
The concession may also lead some doctors to recommend chemotherapy
when patients may not benefit. In a 2001 study of cancer patients in
Massachusetts, conducted by a team of researchers led by Dr. Ezekiel
J. Emanuel of the National Institutes of Health, the authors found
that a third of those patients received chemotherapy in the last six
months of their lives, even when their cancers were considered
unresponsive to chemotherapy.Those findings strongly suggested overuse
of chemotherapy at the end of life.
"We know there is not all appropriate use," said Dr. John Gillespie,
medical director of Blue Cross Blue Shield of Western New York.
But oncologists say they are only trying to respond to their patients'
wishes. And they say they need the profits from the drugs to make up
for high costs in the rest of their operations. They say they spend
enormous sums to have the facilities and employees that enable
patients to receive chemotherapy outside a hospital, under close
supervision.
"It seems to be a wash right now," said Dr. Larry Norton, an
oncologist at Memorial Sloan-Kettering Cancer Center in New York and a
former president of the American Society of Clinical Oncology. He and
his colleagues argue that oncologists treat patients who demand more
care and therefore have higher expenses.
"We're just trying to break even," Dr. Norton said.
Oncologists also argue that patients may suffer if doctors do not buy
chemotherapy drugs directly. They point to a case in Kansas City, Mo.,
in which a pharmacist was sentenced in December to 30 years in prison
for diluting chemotherapy drugs he then sold to doctors who
administered the drugs in their offices. Dr. Norton argued that the
case illustrated why he and his colleagues were worried. "Some
potential problems could arise," he said.
The health plans, and some of the specialty pharmacies that sell to
both doctors and insurers, say this concern is unfounded.
Earlier this month, Representative Pete Stark, Democrat of California,
introduced legislation that would slightly increase what Medicare pays
oncologists for their services but pay doctors closer to what the
drugs actually cost. The government is also looking into how the
concession is affecting prescribing patterns.
Oncologists began selling drugs directly more than a decade ago, after
they persuaded insurers that it would be less expensive to administer
the drugs in their offices than in hospitals. This was part of a trend
of doctors' being paid much more to perform services and treatments in
their offices than in hospitals. (Some other specialists, like
urologists, also profit from chemotherapy drugs, but they administer
them only to some of their patients.)
Over the course of the 1990's, oncologists have been able to rely on
the sale of chemotherapy drugs as an important source of revenue. They
are now among the best-paid doctors, surpassing obstetricians and
general surgeons, according to data from the Medical Group Management
Association. In 2001, the median compensation for an oncologist in a
large practice was $274,000.
While compensation for specialists has increased 19 percent, on
average, since 1997, oncologists' compensation has risen slightly more
than 40 percent.
Dr. Norton dismisses the notion that cancer doctors' compensation has
risen faster because of income from chemotherapy drugs. "Oncologists
are extremely busy," he said, because more people have cancer and more
treatments are available.
But the idea that these doctors make money from the drugs worries
some. "All the evidence suggests that doctors do respond to money,"
said Dr. Susan D. Goold, an associate professor at the University of
Michigan Medical School.
Some oncologists acknowledge that the current system creates a
perverse incentive. The potential for conflicts of interest "is
troubling," said Dr. Edward L. Braud, the president of the Association
of Community Cancer Centers, whose members treat more than half of the
nation's cancer patients.
In several prominent cases, drug companies have also been accused of
using discounts to influence doctors. For example, in the Minnesota
lawsuit, brought last year, Pharmacia is accused of having "induced
physicians to purchase its drugs, rather than competitors' drugs, by
persuading them that the wider `spread' on the defendant's drugs would
allow the physicians to receive more money, and make more of a profit,
at the expense of the Medicaid program and Medicare beneficiaries."
Pharmacia said it could not comment because the matter was still in
litigation.
But others say doctors are solely motivated by what their patients
want - a chance, no matter how slim, of living longer or suffering
less. Dr. Norton, for one, dismissed the idea that oncologists would
be motivated to give too much care or the wrong kind, and said
undertreatment is a much greater risk.
Some insurers are getting oncologists to forgo profits from
chemotherapy drugs, often by paying the doctors more for administering
them. While oncologists may not make as much under the new system, and
some have objected vehemently, it is "palatable," said Dr. Abraham
Rosenberg, an oncologist in South Florida, where the new system is
prevalent.
Last year, inspired by Florida's example, the Blue Cross Blue Shield
plan in western New York began negotiating new contracts with
oncologists.
The UnitedHealth Group is also in discussions with doctors in New York
and expects to begin a pilot program this year. It plans to give
oncologists a choice: they can allow UnitedHealth to buy the drugs at
a lower price and pay the doctors for administering chemotherapy, or
they can accept a lower payment for the drugs if they continue to buy
them. The plan is also talking with doctors in cities including
Cleveland and Dallas.
Aetna is trying different approaches. In the Northeast, the insurer
wants to reimburse doctors at prices that are much closer to what the
doctors are actually paying, while in the Southeast and Southwest, it
is looking to buy the drugs directly.
Richard H. Friedman, the chief executive of the Mim Corporation, which
operates a specialty pharmacy that supplies chemotherapy drugs to
doctors, predicted that the chemotherapy concession may not last. The
health plans, he said, "are all starting to take a much harder look."
Monday September 29, 2003
By Bill Walsh
Washington bureau
WASHINGTON -- Cancer doctors say a provision in Medicare overhaul
legislation pending in Congress would shrink federal financing for
their services so dramatically that they would be forced to close
clinics and turn away patients.
But lawmakers say the doctors' emotional outcry is obscuring a
shocking financial loophole that for years has fattened oncologists'
wallets: They have been collecting from Medicare many times what they
paid for their patients' drugs.
The Bush administration estimates that Medicare profits collected by
oncologists last year amounted to $700 million and projects it will
reach $1.7 billion in 2004 unless changes are made.
"We clearly have been overpaying them in this area," U.S. Sen. John
Breaux, D-La., said.
Unlike most prescription medications, doctors order cancer drugs from
manufacturers directly and then bill Medicare. The program pays 95
percent of the average wholesale price. The problem, as noted by a
General Accounting Office report last year, is that the average
wholesale price is neither "average" nor "wholesale."
"It is simply a number assigned by the product's manufacturer," the
GAO wrote.
Cancer doctors frequently pay far less than the average wholesale
price -- the administration estimates 13 percent to 34 percent less --
because they negotiate private purchasing arrangements with
manufacturers.
Sometimes the discounts are much deeper. U.S. Rep. Billy Tauzin, R-Chackbay,
whose House Energy and Commerce Committee investigated Medicare
overpayments for cancer drugs, said the difference between what some
doctors paid and what they were reimbursed by the government was vast.
The average wholesale price for etoposide, a breast cancer drug, was
$638.76 for 500 milligrams. The price paid by a national group
purchasing company was $28.22, according the committee.
Calcium leucovorin, which is used to treat some colon cancers, was
listed at $18.44, according to figures from the Bush administration.
With Medicare paying 95 percent, doctors would get $17.52. They can
purchase it on the open market for $2.77.
Not only are lawmakers concerned Medicare is paying inflated drug
prices, but that seniors, who must fork over a 20 percent co-payment,
also are getting overcharged.
"No one on the committee is unsympathetic to the plight of cancer
patients," said Ken Johnson, spokesman for Tauzin, whose mother has
undergone three cancer surgeries. "But bilking senior citizens can't
be the answer."
Seeking a balance
The oncologists don't dispute that they have been making a substantial
profit on Medicare-subsidized drugs. But they say they have good
reason: It is to compensate for woeful underpayments from the federal
government for their other services.
The American Society of Clinical Oncology estimates that Medicare
covers about 25 percent of the clinical, administrative and labor
costs associated with administering chemotherapy drugs. It doesn't
cover, the group says, specially trained chemotherapy nurses, costs of
billing and collection, malpractice insurance, overhead for clinics
where the drugs are administered, intravenous fluids and tubing, or
pharmacy costs for mixing the medications for each patient.
"We take the money from drugs to pay for administration," said Dr.
John Rainey, president of the Oncology Society of Louisiana. "All
we're asking for is to be paid fairly for what we do."
It's not that cancer doctors are pleading poverty. A recent issue of
ModernHealthcare magazine published a nationwide study showing that
oncologists earn between $213,855 and $325,000 a year. Still, they say
it's not fair for them to have to subsidize patient costs.
Congress had proposed fixing both problems at once, something
oncologists have been pushing for years: cutting drug payments to
cancer doctors while raising the pay for their services. But doctors
object to the balance House and Senate negotiators have struck.
Although the legislation is in flux, the doctors say that one plan
would cut about $700 million next year from what doctors are paid for
the drugs but raise the pay for their services by about $200 million.
Trickling down
If Congress follows through, doctors say patients will be hurt the
most. In a survey of 2,900 of its members, the American Association of
Clinical Oncology found that 19 percent said they would stop treating
Medicare patients altogether, 42 percent said they would stop
conducting clinical trials in their offices and nearly three-quarters
said they would send chemotherapy patients to a hospital instead of
administering their drug regimen, often an hours-long procedure, in
their offices.
Rainey, the Lafayette oncologist, said he would close four satellite
chemotherapy units and predicts the worst for elderly patients.
"They won't drive 60 miles to get care." He said. "They will go on and
die."
Dr. William Stein, co-founder of the largest cancer-care group in
metropolitan New Orleans, didn't predict that any of the area's 11
infusion units would close. But, he said, he wouldn't administer drugs
in the pleasant environs of his office to patients whose only source
of insurance is Medicare. Instead, they would be sent to the hospital,
where it should belong (A hospital setting would have lower costs).
Floyd Hendricks, 79, a retired thoroughbred horse breeder, has been
getting chemotherapy at East Jefferson Medical Center to treat lung
cancer once a week since July. He said that he calls in advance and
that the drugs are ready for him when he shows up. He spends several
hours at the hospital and called the nurses "the nicest bunch of
people I've ever been around."
But Mary Ellen Kilgore, 64, said a hospital setting can't compare to
Stein's clinic. Chemotherapy patients at the Covington facility are
able to look out at a fountain and butterfly bushes in the "healing
gardens" as they get their drug treatment. Kilgore knows her nurse's
home phone number and said the staff is like family.
"It's a really positive atmosphere, and that is essential to a cancer
patient," said Kilgore, who has leukemia.
The cancer provision is a small piece of the entire Medicare
legislation and only one of many controversial elements. Even if the
bill fails, the fight over cancer treatment is far from over. The Bush
administration has proposed rules to change, without Congress, the
cancer drug payments system and cancer doctors have vowed to fight it.
The key points of H.R. 1622 are listed below.
Payment for Drugs
Medicare payment for drugs administered in physician offices would be
set at 120% of the manufacturer's average sales price (ASP). The
increase over the manufacturer's ASP accounts for the wholesaler's
markup and drug-related expenses incurred by physicians, such as
wastage, opportunity cost of investment in inventory, procurement
costs, and bad dept. If a state or locality imposes a sales tax or
gross receipts tax on drugs, Medicare would also pay that amount.
ASP would be calculated by considering all discounts and rebates.
Prices offered to hospitals, nursing facilities, hospices, HMOs,
govermental entities, and charitable organizations would be excluded,
since those prices are not necessarily indicitave of the prices
available to physicians.
Manufacturers would report their ASPs to the Centers for Medicare &
Medicaid Services (CMS) each calendar quarter, and the amounts would
be used to calculate Medicare payments for the second subsequent
quarter.
CMS would have the option of setting a payment amount for each drug by
the specific drug or, as under the current system, grouping all
versions of a multiple-source drug together and paying the same amount
for all of them.
If a physician actually pays more than the Medicare payment amount for
a drug, Medicare would pay the full amount if the physician documents
the purchase price, unless CMS finds that the payment amount was
unreasonable.
Payment for Drug Administration Services
Medicare would pay the full costs of drug administration services. To
estimate these costs, CMS would be required to use the estimates of
clinical staff time, suppliers and equipment expenses developed in the
clinical practice expert panel process. CMS would use the latest
available data on staff salaries and supply costs to update those
estimates. Direct costs (clinical staff, supplies, and equipment) as
so determined would be deemed to be 33.2% of the total costs. That
figure is based on CMS data on the ratio of total to direct costs for
all physicians, as published in the Federal Register on Aug. 2, 2001
(66 Fed. Reg. 40272, 40377).
CMS would be required to make additional payment when more than one
chemotherapy drug is administered by push technique during the same
encounter.
Payment for Chemotherapy Support Services
Medicare would make a payment for chemotherapy support services, such
as nutrition counseling, psychosocial services, and social worker
services, furnished incident to the physician's services.
The payment would be made on a weekly basis with respect to each
patient receiving chemotherapy and would be based on the costs of
furnishing chemotherapy support services as they are provided in
oncology practices that provide these services in a manner that is
considered high quality care.
Cancer Therapy Management Services
Medicare would be required to establish a new payment amount for
physician's services related to the treatment of cancer patients. This
amount would pay for the extra work that physicians treating cancer
patients must perform before and after seeing the patient. The current
visit and consultation codes assume only a small amount of such work
because the codes are used by all specialists and for all types of
patients.
Other Services without Physician Work Relative Value Units
In addition to drug administration services, there are a number of
other services, including radiation oncology services, that do not
have a physician work component and therefore are subject to the
special "zero physician work pool." payment methodology. This was
adopted as an interim payment methodology, but CMS has not yet adopted
a final payment method. The bill would require CMS to develop a
revised payment methodology that fully pays for the costs of
furnishing these services to Medicare patients.
Physician Supervision of Services
This provision would clarify how services can be billed to Medicare
when "direct supervision" by a physician is required. Direct
supervision means that a physician must be present in the office suite
while the nurse or technician is furnishing the service, but the
physician is not required to be with the patient. Drug administration
services are subject to the direct supervision requirement.
When direct supervision is required, Medicare allows a physician to
provide the supervision. Recently, Medicare has indicated that the
Medicare claim form should show the billing number of the supervising
physician when different from the ordering physician. This creates
difficulties for many physician practices. The bill's provision would
permit use of the ordering physician's billing number, provided that
the medical records identify the supervising physician or physicians.
Institute of Medicine Study
The bill would require a two-part study by the Institute of Medicine.
The first phase would study the current system for delivery of
services to cancer patients, prior to the provisions of this bill
going into effect. Study elements would include an assessment of acess
to care; the range of services, including support services, that are
and that should be provided to cancer patients; appropriate practice
standards; the role of oncology nurses; and development of a framework
for assessing the effects of this legislation.
The second phase of the study would use that framework to analyze the
effects of this legislation after it has been implemented.
Effective Dates
The revised payment rates would go into effect on January 1, 2004.
Pharmaceutical manufacturers would begin reporting average sales by
October 30, 2003.
The clarification of the policy on billing for services supervised by
another physician would be effective upon enactment.
Write your representatives!
Greg Pawelski