2003-09-15 -- We'll give up some healthcare when ...


When ALL of us have the makings of healthy lives before we hit the
ICU:

*  safe and sufficient housing, food, water, air, education, and work,
*  no promotion of cigarettes, liquor, drugs, or junk food
*  preventative health care and primary health care
*  aggressive collection, dissemination, and action on health and
toxicology data,

THEN, maybe we should be willing to talk about reducing the supply of
intensive medical care.

For a piece on the history of promoting rationing in the medical
profession click on
http://home.comcast.net/~mlyon01/articles/twenty.htm


Boston Globe, 9-14-2003

Rationing of medical care under study

Doctors seeking plan as costs soar


A group of doctors and medical ethicists, including physicians from
Brown and Harvard universities, is working to develop national
guidelines for the rationing of expensive intensive-care unit
treatment -- and to get doctors to openly admit they withhold care
from patients who would benefit the least. Physicians and nurses too
often make rationing decisions based on their own biases or their
hospital's financial condition, members of the task force say. This
happens most often with ICU care, which accounts for 20 percent of all
hospital costs, or $142 billion in 2001.

The group is tackling one of medicine's most pressing problems -- the
soaring cost of care, how to pay for it, and who should get it. But
its work is expected to be controversial. In Oregon, the one state
that rations medical care for the poor, the program took a decade to
implement and has outraged patients and doctors. "Most physicians
don't want to admit they engage in it, but the truth is bedside
rationing happens all the time," said Dr. Mitchell Levy, chairman of
the task force, a Brown Medical School professor, and director of the
medical ICU at Rhode Island Hospital. "There's nothing wrong with it;
it shouldn't be taboo. We should do it wisely."

In an informal national poll of 620 intensive care physicians last
year, 55 percent of doctors said they've withheld medication, tests,
or services because they felt the cost outweighed the potential
benefits to the patient, the Society of Critical Care Medicine, a
professional group of intensive care doctors, found. Seventy-four
percent said they would withhold care from a patient who would not
benefit much so they could provide it to a patient who would benefit
more.

Levy took these results and persuaded Eli Lilly and Co., which is
concerned that doctors are rationing its sepsis drug Xigris because of
its high cost, to give his group a $1.8 million grant. Brown Medical
School has appointed an impartial observer to watch for
conflict-of-interest, and Levy said the group won't make
recommendations regarding Xigris.

It will not be easy to get physicians, hospital administrators, and
the public to agree on which patients deserve expensive care and which
don't.

Some hospitals, for example, deny Xigris, which costs about $7,000 for
several days of treatment, to patients with less than three months to
live. But Charles Inlander, president of the People's Medical Society,
a national nonprofit medical consumers' organization, said he
disagrees with that approach. "What if the person is an official who
has a huge and important foreign policy decision to make in the next
three months," he said. "Should you still make the decision not to
treat them even if they don't have long to live?"

Inlander, who was appointed to the task force to represent patients,
said hospital executives shouldn't be the ones to decide how to ration
care. Since they must earn a profit, they have an inherent conflict of
interest. "My fear is that care will go to people who can pay," he
said. "Rationing these days is built around age, race, and economic
status. It's done under the table. It's a very important issue to face
head-on. But any standards they set up still have to be accepted by
the public."

Members of the task force said rationing has occurred for years, but
may be becoming more prevalent because the cost of medical care is
growing more rapidly and certain resources, such as ICU beds, are
dwindling. The number of ICU beds shrank to 52,968 in 2001, a 7.2
percent drop in six years, because they're so expensive for hospitals
to run and staff.

"We're making triage decisions all the time about who deserves to be
in the ICU," said Dr. Andrew Villanueva, director of the medical ICU
at Lahey Clinic in Burlington. He said that often the most care goes
to the patient whose family "pushes the hardest."

Villanueva and other physicians in Boston-area ICUs deny that they
withhold care based on cost. But they acknowledge that they do
consider cost when patients don't have long to live.

Last month, a 75-year-old woman with incurable cancer was wheeled into
the ICU at Tufts-New England Medical Center, said Dr. Stanley
Nasraway. She had just a few months to live, and to complicate matters
she had needed emergency surgery.

Her family wanted aggressive care, including artificial life support,
so that's what Nasraw ay was providing. The danger was that she could
develop a life-threatening infection; if she did, Nasraway knew he
might have to stop. The treatment is one of the most expensive drugs
to hit hospitals in years. "You don't just roll out a $6,800 drug for
someone whose prognosis is less than six months, when the adverse
effects can be significant, and the patient is terminally ill," said
Nasraway, director of the surgical ICU unit and co-director of the
cardiothoracic ICU.

The tough question is how to decide which patients get expensive care.
Should a patient's age matter? Should doctors use more resources on a
terminally ill 12-year-old than on a terminally ill 80-year-old?

Oregon created a list of medical conditions and treatments, ranking
them for their effectiveness, cost, and value to society. Preventative
care, such as mammograms and prenatal visits, are at the top of the
list, while untreatable ailments, ranging from the common cold to
end-stage cancer, fall to the bottom. About 700 conditions are on the
list and the state pays to treat 550 of those.

But the public was outraged in 1999 when the state refused to pay for
a liver-lung transplant for an 18-year-old with cystic fibrosis. The
state covered lung transplants and liver transplants but said the
combination was not on the list because it's unproven. Public
donations eventually raised enough money to pay for the $250,000
operation, but Brandy Stroeder died before doctors could find healthy
organs.

Beginning this fall, Levy's group, called the Values, Ethics, and
Rationing in Critical Care Task Force, will take a different approach.

The group is gathering data for a series of journal articles, to be
published within the next year, defining rationing and discussing
models for it. The task force will also conduct focus groups with
doctors and nurses and develop a computer program that will allow
hospitals to plug in various treatments and compute how many lives
their expenditures will save.

The 20-member task force, which Levy organized at the end of last
year, also includes Dr. Robert Truog, a Harvard Medical School
professor and chief of the division of critical care medicine at
Children's Hospital.

But the second step will be far more difficult: How does the group
decide how much money saving a life is worth? Levy said that question
will be answered by ethicists, economists, physicians' patients
groups, and politicians at a series of conferences. Hospitals and
doctors can develop rationing policies on their own and don't need
federal approval.

Federal officials, debating whether Medicare should cover dialysis,
first assigned a dollar figure to a year of life during the 1970s,
said Peter Ubel, author of the pro-rationing book "Pricing Life." They
arrived at $50,000, the cost of a year's worth of dialysis for a
patient with advanced kidney disease. As a result, policy-makers and
researchers have used this number to advise doctors, hospital
administrators, and state and federal Medicaid and Medicare officials
about whether particular treatments are worth paying for.

Ubel, who is at the University of Michigan, believes that number is
too low. Based on public opinion surveys, he thinks a year of life is
worth closer to $150,000 to $200,000. But, he said, using a hard and
fast number is "just so cold." Society should consider emotional
factors too, he said, such as whether we want to provide all possible
care to veterans because they defended the country.

Many policy specialists say that coming up with national rationing
guidelines will be too hard, partly because guidelines become obsolete
with new treatments and new studies about their effectiveness for
certain groups of patients.

And even though parallels exist between the right-to-die movement of
the 1970s, which was ultimately successful, and the rationing
movement, Ubel said there's a key difference. The right-to-die
movement -- which made the secret practice of withdrawing life support
from patients in irreversible comas acceptable -- was a populist
uprising about patients' rights.

"We thought, `How can we take people off ventilators?; it's crazy. Now
it's commonplace," Ubel said. "Rationing is a much harder sell. The
benefits to the public -- lower taxes -- are far more indirect."



Price of Heart Device May Mean Rationing

By THERESA AGOVINO AP Business Writer

September 1, 2003, 1:59 PM EDT

NEW YORK -- The high price of a new heart device called a HeartMate
may lead to rationing with perhaps one of every 15 people who need it
actually getting it.

Financially struggling hospitals probably will not absorb the roughly
$95,000 to $145,000 gap between what it costs and what Medicare is
willing to pay for it. If everyone who needed one received one, it
could cost Medicare $15 billion to $20 billion a year.

Ron Johnstone is a very lucky man.

Three years ago, he thought he was dying of chronic heart failure.
Then 70, he wasn't a candidate for a heart transplant because of other
health problems, and medicine wasn't working. Two years ago, he was
given a device, called a HeartMate, and today he hunts, fishes and
plays golf around his Hugo, Minn., home and runs a small antique
store.

"I've got a new lease on life," Johnstone declared.

Indeed, he has lived more than twice as long as the 8.5-month average
for patients who receive a HeartMate, but not everyone may be so
fortunate.

Johnstone didn't have to worry about that because he received the
device as part of a clinical trial.

But experts say there are about 100,000 people a year like Johnstone
who could benefit from the device, and the manufacturer, Thoratec
Corp., estimates it will be selling just 5,000 to 15,000 a year in
three to five years.

"If hospitals could make $100,000 from implanting one of these, I'd be
giving you different sales projections," said Thoratec president and
chief executive D. Keith Grossman.

While some insurers have agreed to pay for the device, Medicare is
crucial because it is the government insurer for the elderly, the
biggest group of chronic heart failure patients. Medicare is expected
to announce shortly that it will pay $55,000 for hospitals to install
a HeartMate, but that's still far short of the estimated $150,000 to
$200,000 it actually costs.

HeartMate's evolution illustrates the nexus of a health care system
beset by an aging population, rising costs and limited resources and
the longing for lifesaving technology often made by companies seeking
to maximize profits. The conflict is expected to become more heated as
more expensive technologies and procedures are developed, and at least
in their infancy are not overwhelmingly effective. It will be
especially difficult for Medicare, facing the baby boomer retirement
wave and already searching for a way to finance a prescription drug
benefit.

"Technology is being created faster than our ability to put in any
kind of a financial, ethical and moral framework," said Dr. Allen
Korn, chief medical officer of the Blue Cross and Blue Shield
Association, which issued a report saying the device qualified for
reimbursement.

"Nobody wants to hear they are going to die. But somewhere there needs
to be a bottom line," Korn said.

Adds Art Caplan, chairman of the department of medical ethics at the
University of Pennsylvania's medical school, "We are headed for a big
political debate about rationing health care -- a debate no one wants
to have."

HeartMate originally was used as a bridge for patients awaiting a
heart transplant. In 2002, the Food and Drug Administration approved
it as a permanent solution for people with chronic heart failure who
are ineligible for a transplant.

HeartMate is a left ventricular assist device implanted near the
heart. Blood drains through a tube from the left ventricle, the
heart's main pumping chamber, and is circulated through the body. A
second tube extends outside the body and is attached to a battery
pack, worn on a shoulder holster.

A clinical trial of 129 patients sponsored by The National Institutes
of Health found that the average patient lived 8.5 months after
getting a HeartMate. Patients had a 52 percent chance of surviving for
one year, compared with 25 percent of those being treated only with
medicine. The two-year survival rate was 23 percent for the HeartMate
group, 8 percent for the others.

However, the frequency of severe complications such as infection and
bleeding was 2.35 times greater with the HeartMate, which had a 28
percent infection rate within three months.

And as with any new technology, there are bugs. Johnstone's first
HeartMate, in fact, malfunctioned because of a problem with the valve
and had to be replaced. Overall, in its first two years, the device
had failed 35 percent of the time, and 10 patients needed a
replacement.

Grossman said the device costs between $60,000 and $65,000.
Discounting the price is difficult, he said, because Thoratec needs to
recoup its development costs and continue pushing $30 million into
research to improve HeartMate.

In 2002, Thoratec's revenues reached $131 million and it finally made
a profit. At such a small company, even a moderate sales increase can
propel earnings. Analysts anticipate that even with rationing,
Thoratec's earnings will jump 30 percent next year because of the
Medicare decision.

Grossman added that Thoratec will help hospitals apply to Medicare for
additional money and hopes to bring reimbursement to $100,000.

Doctors and analysts expect reimbursement levels to rise and prices to
eventually fall, especially if there is competition. World Heart Corp.
hopes to get approval for its version by the end of the year.

A panel of outside experts recommended that Medicare pay for the
HeartMate, and Medicare typically follows the panel's advice. A
decision is due by Sept. 16, though Medicare has missed two other
self-imposed deadlines.

Dr. Sean Tunis, chief medical officer of the Centers for Medicare and
Medicaid Services, said price isn't a factor in the decision, but he
acknowledged there is greater scrutiny of something that will cost the
agency billions of dollars.

Reimbursement levels are based on complicated formulas involving what
hospitals charge for related procedures. Often the levels are too high
or too low, but officials said hospitals should break even.

The agency also wants to establish a system to monitor the device's
effectiveness since approval would mean more people receiving it.
Also, Tunis said the device had "extremely high costs for an
end-of-life technology" which he considered "marginal."

"Marginal is a loaded word," Tunis said. "Six to 12 months of life is
important, but this doesn't strike me a breakthrough technology that
many patients will go for."

Tunis said part of Medicare's mission to pay for new technologies
despite flaws so companies and the medical community can improve them.

Some suggest Medicare will limit the centers that can implant the
device, which leads to de facto rationing. But doctors say that isn't
a negative because only advanced cardiac care centers should do it.

"You don't want hospitals putting this stuff in willy nilly," said Dr.
Mehmet Oz, director of the Cardiovascular Institute at New York
Presbyterian Hospital-Columbia University. "You don't want them to
make the same mistakes we did."

Oz said his center will absorb the losses to advance the field.

Dr. Lynne Warner Stevenson, co-director of the heart failure program
at Brigham and Women's Hospital in Boston, said only a few of its
patients will receive the device because of the cost.

"The fact that resources are finite is something the U.S. is waking up
to very late," Stevenson said. "We ration care all the time."