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Medicare Challenged On Catheters
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Paraplegic, Renzi fight reuse policy
Jon Kamman
The Arizona Republic
Feb. 19, 2006 12:00 AM
The lives of tens of thousands of disabled people depend on taking a narrow tube in hand and threading it into their bladder to drain urine.
Because urinary catheters invade the body, the Food and Drug Administration requires that they be manufactured and packaged under the highest standards of sterility.
The only catheters approved by the FDA for sale in this country are for single use only. Manufacturers are prohibited from suggesting reuse.
Yet, under a policy of the nation's $340 billion Medicare program, which serves the disabled of any age, self-catheterizing patients have no choice but to reuse a catheter perhaps 35 to 40 times, sometimes after only rudimentary cleansing.
Now, Mesa paraplegic Steve Winter is appealing to Congress and federal agencies to end what the disability community and a growing number of health care professionals condemn as a primitive, life-threatening practice.
Medicare pays for only one "single-use" urinary catheter a week. It costs taxpayers $1.81.
The forced reuse saves roughly $65 to $75 a week in supply costs.
But if repeated use makes infections more likely, as many believe, the consequences are soaring medical costs, disrupted family and work lives and, not least, personal suffering.
"It's terrible administrative policy, absolutely terrible, and it needs to be changed," U.S. Rep. Rick Renzi, R-Ariz., said after Winter and other advocates met with him in December in Washington, D.C., for a teleconference with Medicare and FDA officials.
Urinary-tract infections are pervasive among catheter users, and the cost of combating one can quickly reach tens of thousands of dollars as treatments escalate from doctor visits and antibiotics to hospitalizations and kidney dialysis.
Winter wants Medicare, along with any Medicaid or private insurance programs that have adopted its policies, to comply with the FDA's "single-use only" standard by providing a new, sterile catheter for each urination, or void.
"This is not just something we want," says Winter, who is devoting most of his time to the issue. "It's something we need."
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Reuse is common
How many people are reusing catheters is not known. Medicare does not break out figures on such variables as long-term vs. temporary use or hospital vs. usage in home care. State-run Medicaid programs differ in the number of catheters they supply, and private insurers also have wide variations.
Winter's best estimate is that 30,000 to 40,000 people with spinal-cord injuries, or about 15 percent of those in that 250,000 population, are limited to one catheter a week. In addition, tens of thousands of people afflicted with multiple sclerosis, spina bifida and other conditions also are reusing catheters, experts estimate.
Many defenders of reuse insist that medical research has proved the method safe. That does not mean total freedom from infection, they explain, but neither does single use. Repeated catheterization almost inevitably leads to an infection at some point regardless of the instrument's sterility.
Winter counters, "We've seen people who used to get three or four infections a year (on the reuse method) go for two or three years after getting sterile catheters. That's a big difference."
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Windfall profits?
As much as health, money is the crux of the issue.
Advocates of reuse say the push for change is mostly a ploy by catheter-makers and distributors to reap windfall profits.
It's an accusation that Winter regularly confronts on both the policy and personal fronts.
On the policy level, science and logic argue for sterility regardless of who might profit, say Wilson and medical experts who support his view.
On a personal level, he was a catheter wholesaler for nine years until 1999. Now a consultant to a Phoenix medical-supply company that deals mainly in catheters, he performs no sales work and receives no commissions, he says, but is provided private insurance that pays for a full supply of sterile catheters.
"I have nothing to gain personally from a change in policy," says Winter, the victim of a shooting that has left him in a wheelchair for more than half of his 46 years. "I'm doing this for everyone in a chair."
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Absence of evidence
One of Winter's greatest frustrations is that the argument is being waged without definitive evidence.
No broad-based, scientific study has ever compared infection rates between using a catheter for a week and using a sterile one for every void, according to Winter and Mary Nancy Young, a rehabilitation nurse now retired in Sun Lakes.
When pressed by Renzi to justify providing one catheter a week, Medicare officials listed seven academic papers.
Five date from more than a decade ago. Another, involving only 10 children, carries an author's warning that it should not be used to formulate policy.
The latest is a 2004 report from Thailand examining whether a specially designed catheter, not approved for U.S. sale, can be used for years. Although many of the 23 participants in the study contracted illnesses and four had kidney damage, the verdict was yes, that it could be suitable for developing countries with limited health care resources but with the caveat of a heightened risk of infection.
"It's ridiculous to be relying on those papers," Renzi says.
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Dangerous process
Every few hours of every day, hundreds of thousands of sensory-impaired Americans thread a catheter through their urethra and into their bladder to perform a function the able-bodied world takes for granted.
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With each self-catheterization, starting sterile or not, they can only hope they've gotten away with invading their bodies without depositing germs that could trigger a urinary- tract infection, one of the most common but potentially lethal illnesses a paralyzed person can face.
Under the one-a-week supply approved by Medicare and like-minded payers, a single- use catheter is used five or six times a day.
Medicare itself does not prescribe how to clean, dry and carry the tubes between uses but alludes to such suggestions as this from a Florida urology clinic:
"It may be helpful to soak the catheters in a white-vinegar solution once a week to control odor and remove thick mucus deposits," the clinic instructs.
The one-catheter issue applies only to self-care because hospitals are prohibited from reusing urinary catheters and most other medical devices. Rules hammered out by Congress and the FDA five years ago require the few categories of instruments approved for reuse be reprocessed to original sterility and durability.
Under Medicare regulations, one of the few ways to qualify for a sterile catheter for each void is to contract not once, but twice in one year, an infection documented by a high count of urinary pathogens, a fever of at least 100.4 degrees and aches and pains.
"It's a reward for getting sick," Winter protests. "Have you ever heard of a policy that encourages you to get sick before giving you what you need to stay well?"
A urinary-tract infection can become debilitating quickly, Winter says, in part because people who have no feeling in the affected area may not respond to early symptoms.
"You're going along fine, and then, bam, it hits you," he says.
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Russian roulette
Dr. Patrick Tennican, a specialist in internal medicine and infectious diseases at the University of Washington, likens reusing a catheter to playing Russian roulette. A patient may escape harm for a while, he says, but it takes only one contamination to trigger what can become a serious infection.
"If you introduce something dirty into what is supposed to be a sterile part of the body, it's logical that you'll be increasing the risk," Tennican says. Even mild infections have a cumulative effect that could result in the need for dialysis or worse, he emphasizes.
"(The issue) has been shoveled beneath the rug for years," Tennican says. "We should be asking, 'How can we do better than 20 years ago?' instead of 'Can we get away with it for another 10 years?' "
A top rehabilitation doctor in Phoenix agrees, saying he does all he can to help patients avoid multiple use.
"If you were out in the middle of the desert and had no other means, reusing a catheter is a way to do it. But I'd rather have less of a chance of infection," says Dr. John Porter, who operates a private clinic and is in charge of inpatient care at Phoenix Rehabilitation Hospital.
In addition to the infection danger, catheters can become stiffer and more abrasive with repeated use and home cleansing, heightening trauma to the urethra, Porter warns.
Porter and many other medical authorities also stress that the growing resistance of bacteria to antibiotics makes it unadvisable, if not counterproductive, to try to ward off infections through the once-common practice of keeping patients on a permanent, low dose of medication.
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FDA inaction
The FDA has not challenged the Medicare policy, which appears to contradict the strict standards of purity, sterility and safety the regulatory agency is charged with enforcing.
In a letter to Winter's congressman, GOP Rep. Jeff Flake, an FDA official as much as endorsed reuse.
Patrick Ronan, associate commissioner for legislation, acknowledged that the only catheters approved for sale in this country are for single use only but observed that "the current practice of medicine" is to reuse them.
"These types of catheters are only briefly inserted into the urethra and therefore have a much lower risk of causing an infection compared with indwelling catheters (which remain in place for days or weeks)," Ronan wrote.
The FDA has no official guidelines for cleaning catheters, but physicians' recommendations "include a thorough washing with soap and water and/or bleach until the catheter shows signs of degradation," the letter says.
"Could you imagine what the FDA would do if they inspected a catheter plant and the manufacturer explained that to save money, they were just washing the catheters with soap and water before packaging them?" Winter asks. "They would be shut down immediately."
Indeed, John Anderson, marketing director for Mentor Corp., a California maker of medical devices, recalls that in the 1990s, the FDA shut down the company's catheter production line.
The halt was initiated not because the products weren't sterile but because they were being packaged four to a bag.
The FDA's reasoning was "open the bag to use one and the others would no longer be sterile," Anderson says. "Everything has to be for single use, packaged separately."
FDA spokeswoman Julie Zawisza emphasizes that all medical devices are marketed for single use unless the manufacturer presents evidence that reuse is safe.
The FDA regulates only manufacturers and can penalize them for giving advice about reuse but does not have authority to stop consumers or clinicians from using a device "off label," Zawisza says.
Neither does the FDA have power to stop Medicare, its sister agency in the Department of Health and Human Services, from applying rules that make reuse inevitable, she says.
"But we certainly could have a dialogue or discussion about these kinds of things," Zawisza says. "If we think there's a real safety issue or public health issue and we need to get involved, we do get involved."
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Congressman objects
After Winter visited his office, Renzi had no doubt that it is a serious public health problem. The lawmaker issued an ultimatum.
"We've said (to Medicare): Either you change it administratively or we'll legislate it," Renzi says.
The House leadership has authorized him to introduce a bill, if necessary, Renzi says, but he hopes to have the policy changed administratively.
"This could be fixed right now with a field memo from the top," Renzi says. "There're no sound principles that the agencies are standing on, and it's a complete injustice."
Flake also has aided Winter's cause, and Arizona GOP Sen. John McCain is awaiting answers to inquiries he has made to the agencies.
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Costs, consequences
Not all paralytics and wheelchair patients perform intermittent catheterization, and individual frequency varies. But at the rate of six a day, the cost of a new unit for each void would approach $4,000 a year, compared with less than $100 today.
Winter and fellow critics say a fully scientific study would show that the one-a-week limit is a false economy because it exacts a higher toll in infection, kidney impairment, hospitalization, suffering and death.
Statistics bear out the dangers of infections for paralytics, although the numbers say nothing about the causes of illness.
A 2004 study led by Dr. Diana Cardenas of the University of Washington Department of Rehabilitation Medicine found that diseases of the genitourinary system were the leading cause of rehospitalization of patients with spinal-cord injuries.
A decade earlier, a survey of 800 patients by Michael DeVivo of the University of Alabama found that about one-fourth had at least one hospitalization in the previous year and many had more than one. Again, urinary-tract complications were the leading diagnosis.
Another DeVivo study ranked urinary-tract complications fifth as the primary cause of death and first as a secondary cause.
On average, a patient hospitalized for a urinary-tract infection stays eight days at a cost of $20,000, according to inflation-adjusted figures from a DeVivo study.
Dialysis requires repeated treatments at a cost of $20,000 to $30,000 a year.
The limit on catheters raises a larger question about coordination between two parts of Medicare, designated A and B and operated with separate budgets and responsibilities.
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Cost-shifting?
Critics charge that by scrimping on such items as catheters, Part B, which pays for doctor bills and supplies, may simply be transferring larger costs of illnesses to Part A, which pays for hospitalizations, dialysis and other high-cost care.
Medicare officials did not respond to questions on that or other topics submitted three times since December for this article. In a letter to Flake, one administrator said the agency has not studied the possible cost-shifting effects of the catheter-limit policy.
The practice of reuse is deeply entrenched. In 1971, a renowned urologist, the late Dr. Jack Lapides of the University of Michigan, reported success in introducing patients to the then-novel concept of self-catheterization.
What the medical community never grasped, according to Winter and other critics, is that Lapides' study made only casual reference to reusing catheters.
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Untested theory
The study's thesis was that infections and kidney damage were mainly the result of not keeping a healthful flow of fluids through the body. Staying hydrated and voiding frequently - that's where self-catheterization came in - would wash the system and keep urine from backing up into the kidneys, the paper says.
The theory has proved valid, but the safety of reusing catheters was never tested. Lapides and associates simply declared reuse safe. The researchers did so again in a 1974 follow-up. The study made no comparison of sterile and reuse but reported a 35 percent rate of serious infection among 100 patients.
By 1992, the so-called clean technique of washing and reusing a catheter had won endorsement by a panel of researchers, clinicians and consumers assembled by the National Institutes of Health but without citing scientific evidence.
In 1995, the only study ever to suggest a once-a-week change of catheter was published. It was limited to aged men in a nursing home, and many who were reusing catheters also were on a constant dose of antibiotics.
Months later, Medicare adopted its one-a-week policy.
In the late 1990s, the federal Agency for Health Care Policy and Research commissioned the Rand Corp. to conduct an exhaustive review of research papers published in the previous 20 years on urinary-tract infections among people with spinal-cord injuries.
Career rehabilitation nurse Young, one of 13 professionals and consumer advocates who assembled hundreds of papers for consideration, summarizes:
"The Rand report basically said the research (on reuse) stinks." She points out that there have been no relevant studies since then.
Even under the most sterile conditions, virtually everyone using catheters will develop a urinary-tract infection, says Dr. Roger Dmochowski, chairman of the American Urological Association committee that oversees safety-related issues and practice standards.
Many will suffer several a year, he says, and should be allowed a much larger - "infinite, if you will" - supply of catheters.
"(But) the technique of soap and water with an occasional sterilization of the catheter, either boiling or microwaving it for a few minutes once or twice a week, is generally acceptable for the majority," Dmochowski says.
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Expense a factor
In his practice, he says, he starts many patients on the reuse regimen "quite frankly because of the expense," which they may have to bear themselves.
"In a world of infinite resources, it might be that you could reduce the number of infections somewhat by having a new catheter with every catheterization or even a new one every day," the doctor says.
"Unfortunately, this is probably not doable, especially today with where we stand on health care dollars."
Loretta Fauerbach, a Florida hospital infection-control director and board member of the Association for Professionals in Infection Control and Epidemiology, defends catheter reuse as safe in a home setting, where patients have developed many defenses against their own contaminants.
"Basically, I think you're trying to make a problem where a problem doesn't exist," Fauerbach says. "Usually if there's a major health concern with something, something that's done so repeatedly and so often, someone would be saying, 'Whoa, this is causing problems.' "
That's what Winter and supporters are saying, but their motives are questioned if they are involved in catheter sales.
At a north Phoenix medical-supply firm, catheter salesman Gary Hershey says, "That's one of my hesitations in talking with you. People will say, 'Obviously, he wants to sell more product.' "
But Hershey has more than commercial motives for advocating for all catheter users.
Injured 31 years ago at age 16, Hershey has limited use of his limbs, maneuvers both in a wheelchair and walker and is president of the Arizona Spinal Cord Injury Association.
"There are a lot of people out there who have fought (for single use) for years," he says. "For us, it's just good urological care. It's a health issue. . . . It's about quality of life."
Winter's brother-in-law, Dan Roman, who has assembled some of the data for Winter's presentations and accompanied him on the visit to Renzi in Washington, is regional sales manager for a catheter dealer.
"We've seen that (a sterile supply) makes a tremendous difference," Roman says. "I really see it as the right thing to do. We're not going to get rich if there's a change, and if it's approved, it could save Medicare money."
For his part, Winter recalls the day he ran out of sterile catheters and had to wash one in a restroom at LaGuardia Airport in New York.
"I'm at the sink wondering how long it has been since it was cleaned and who has used it since," he says.
"Then I have to roll across to the stall. How do you do that and keep your hands clean? Even floors in hospitals aren't sterile, so what's at an airport?
" I don't know how these guys who have to reuse them all the time can do it."
Reach the reporter at jon.kamman@arizonarepublic.com or (602) 444-4816.
The Above article is provided by: The Arizona Republic - http://www.azcentral.com/arizonarepublic/
Last Update:
January 19, 2007 4:45 PM
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