Author: Jon Merz
Date: 11-05-04 09:27
Source: NY Times
URL:
http://www.nytimes.com/2004/11/05/health/05medicare.html
Date published: November 5th 2004
from Haavi Morreim:
November 5, 2004
Medicare Covers New Treatments With a Catch
By GINA KOLATA
For the first time in its history, Medicare has systematically begun to make
payments for new and expensive treatments and diagnostic tests conditional
on agreement by companies or other groups to pay for studies on whether
these new methods actually work on the Medicare patients who get them.
The move was decided by the agency's recently appointed director, Dr. Mark
McClellan, who said the goal was better and more cost-effective medicine.
The new initiatives began this year when Dr. McClellan, who is both an
internist and an economist, decided that evaluating treatments for elderly
Americans falls under Medicare's purview to pay for whatever is medically
necessary. If the treatment does not work, he argues, then it really is not
medically necessary, and Medicare should not be paying.
Over the past six months, he has been fundamentally transforming Medicare's
scope by offering to pay for a number of new and expensive treatments and
diagnostic tests - ranging from $30,000-a-dose cancer drugs to brain scans
to diagnose Alzheimer's - but with a catch. Patients can only have them if
they enter into studies that evaluate how well they work. And someone other
than Medicare will have to pay for those studies.
In the past Medicare just paid the bills or said no to treatments. Now, with
a flood of promising but astronomically expensive treatments and little data
on how they work in the real world, Medicare has decided to use its 41
million beneficiaries to get some answers. And it is using the threat of
refusing to pay unless patients are in a study as a cudgel to get companies
or foundations or professional groups to pay for the research.
The goal, Dr. McClellan said, is better and more cost-effective medicine.
"Instead of having 10 to 20 percent success rates over a broad population,
we want to get to 80 to 90 percent who will benefit, and with fewer side
effects," he said.
At issue are questions that will determine the future and price of health
care: Do new cancer drugs costing $10,000 to $20,000 a dose help in many
situations where they are now being prescribed? What are the long-term
effects of weight-loss surgery, costing $30,000 to $40,000 per operation
even when there are no complications? How well do implantable defibrillators
for heart patients, each costing $35,000, work? Will PET scans to look for
early Alzheimer's disease, costing $1,670 per scan, make any difference?
"It's a whole new role for Medicare," said Dr. Sean Tunis, Medicare's chief
medical officer.
In many ways, Medicare officials say, they are forced to take the lead
because their beneficiaries are the biggest users of the new drugs and
medical devices and no one else is getting the information that patients and
doctors need to decide on treatments. Medicare itself has no research
budget, the National Institutes of Health can only do so much with its
budget and private companies often have a narrow focus in studies they pay
for.
Now, with medical costs soaring, with Medicare's budget at $320 billion and
with estimates that a third of all medical expenditures are for unnecessary
or ill-advised treatments, the stakes are enormous.
And with Medicare the dominant payer for elderly Americans, who are most
likely to need the treatments, its clout, when it insists on studies, is
substantial.
When Medicare says it will only cover treatments for patients enrolled in
such studies, that's "a pretty big stick," said Dr. Stephen Hammill,
president of the Heart Rhythm Society.
Reaction among those who may end up paying for new research has been mixed.
Some are going along; others are arguing why them? But Medicare holds a
powerful hand - its beneficiaries are the biggest users of drugs and medical
devices, and private insurance companies often follow Medicare's lead on
coverage decisions.
The problem arises because while drugs and devices are tested and evaluated
by the Food and Drug Administration before they come on the market, those
tests often leave huge gaps in doctors' knowledge of how well they work, and
for whom.
The tests to gain F.D.A. approval "leave an awful lot of ground uncovered,"
said Dr. Richard Platt, professor and chairman of the department of
ambulatory care and prevention at Harvard Medical School.
They do not tell doctors or patients whether an older and cheaper drug is as
good as or better than a newer one, for example. And they do not reveal
whether older people, with many medical conditions, will fare as well as the
generally younger and healthier people on whom the drugs or devices were
tested.
"The best way to learn about practical problems and practical benefits," Dr.
McClellan said, "is to evaluate how treatments do in real world settings."
Dr. Platt and other academic experts, as well as patient advocacy groups
like the Center for Medical Consumers in New York, agree, and applaud the
new Medicare initiative.
It is so compelling, said Dr. Robert Califf, director of the Clinical
Research Institute at Duke University, that "almost regardless of your
political philosophy, this makes sense."
"We have an increasingly powerful array of drugs and devices and a
bewildering array of choices," he said. "And there is a broad agreement
among people who make these choices that we don't have the information we
need."
The dearth of information reached a crisis with cancer drugs, Dr. Tunis
said, when new drugs, so called biologics, began reaching the market.
With cancer drugs, he said, the tradition is to test new medications in
situations that their makers think are most likely to show benefit. That
leads to approval by the F.D.A. Then the drugs often come into widespread
use off-label - doctors give them to patients with different cancers or in
combination with other drugs, trying them out in new contexts. Medicare is
required to pay for the original approved use and for uses listed in certain
drug compendia. Other than that, Medicare payments for off-label uses are up
to the discretion of local contractors to the agency. Some pay; others do
not.
The system was never questioned until about two years ago, when Zevalin, or
Ibritumomab tiuxetan, made by Biogen Idec, was approved for non-Hodgkin's
lymphoma, at a cost of about $25,000 a dose, and Medicare started paying the
bills. Medicare administrators were taken aback by the price. They also
worried that it would be widely used in patients other than those with
non-Hodgkin's lymphoma, and that taxpayers would be paying for it without
anyone knowing how well it worked in these untested situations.
More biologics began to be approved. "Each one of these biologics hits the
market with a price tag of $10,000 to $30,000 a dose," Dr. Tunis said. "It
is one thing to try through clinical experience and trial and error to learn
the off-label uses of drugs that cost $100 to $200 a dose. It is another
thing with biologics that are not only expensive but can have pretty
significant side effects."
The agency decided to use its influence to speed up research on off-label
uses of four new drugs approved for colorectal cancer - oxaliplatin,
irinotecan, bevacizumab and cetusimab.
On Monday, Medicare said it would require national contractors to pay for
off-label uses of the drugs for patients in any of nine clinical trials
being started by the National Cancer Institute. That way, Dr. Tunis said,
Medicare hopes to encourage patients to enter the studies, which will
determine whether the drugs are effective in the new contexts.
CancerCare, a nonprofit group providing support services to cancer patients
and their families, was delighted.
"What I most impressed with is to see C.M.S. really focused on this issue of
quality and not just as acting as a payer," said Diane Blum, the group's
director, referring to the Centers for Medicare and Medicaid Services. "It
is an enormous step forward and I hope the patient community pays
attention."
For PET scans for people with suspected Alzheimer's disease, Medicare
announced on Sept. 15 that it would pay only if patients are in a clinical
trial in which they will be randomly assigned to have a PET scan of the
brain, or not. The agency wants to know whether early diagnoses with the PET
scans make a difference in the medical care that patients receive, the
course of their disease, and outcomes like the time before patients are
admitted to a nursing home.
The makers of PET scanners have agreed to do a clinical trial with Medicare
beneficiaries, said Dr. David Rollo, the chief medical officer for Siemens
Medical Systems. He said that there are many logistical problems to sort out
in this first-ever industry-wide collaboration because each machine is
different, "each manufacturer brags that theirs is the best" and yet, in the
study, the brain images must be comparable no matter what machine is used.
On Friday, the PET scan manufacturers will have a conference call with
Medicare officials to plan how to proceed, Dr. Rollins said.
On Sept. 28, Medicare issued a proposal to pay for implantable
defibrillators for hundreds of thousands of patients with severe heart
disease, but who have not had a heart attack, but only if they are in a
national registry to follow the outcomes. The questions the agency wants
answered, Dr. Tunis said, include: Who is still alive in 6 to 12 months?
Whose defibrillator actually went off, shocking their heart back to life?
Does it matter whether a cardiologist or general surgeon put the device in
the patient's body? Does it matter which brand of defibrillator a patient
receives?
But the defibrillator makers are not enthusiastic about starting a registry.
"The first option is that C.M.S. should pay for it," said Peter Gove, a
spokesman for St. Jude Medical, a defibrillator maker, referring to the
Centers for Medicare and Medicaid Services.
The Heart Rhythm Society is meeting with the makers of implantable
defibrillators and other groups next week to discuss what to do. "I think
there will be funding from somewhere," Dr. Hammill said.
In September, the agency proposed similar restrictions on paying for stents
to open blocked carotid arteries in the neck for patients, like many elderly
Americans, who are at high risk of stroke from such an obstruction, but who
cannot tolerate surgery.
And after a meeting yesterday of a Medicare advisory committee, which said
there were large gaps in knowledge about the safety and long-term effects of
weight-loss surgery for the extremely obese, Medicare officials said they
were thinking of requiring a registry for that treatment as well.
Medicare does not intend to force studies of everything it pays for.
Instead, Dr. Tunis said, "We plan to do this for treatments that are
potentially very important to the Medicare population but for which the
evidence is not yet definitive."
While there may be opposition to Medicare's newly aggressive approach,
patients, and taxpayers, can only be better off, Dr. Califf said.
"We have a huge budget deficit and looming huge costs for health care," he
said. "And we know we are spending huge amounts of money on things that
don't work. But we don't know what they are."
So, he said, the nation has a choice. "Medicare could pay for everything, or
we could develop a rational system to pay for the things that matter."
Copyright 2004 The New York Times Company
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