Home Uterine Monitors Give Birth to Debate : Medicine: Many insurers pay for the devices, convinced that they cut hospital time in risky pregnancies. But critics see a lack of test data proving effectiveness.

Six-and-a-half weeks before she was due to deliver her first baby, Lynn Dasteel felt that something was very wrong. By the time she reached the hospital, she was 90% along into delivery, and she had not felt a single contraction.

Her newborn had to spend a month in intensive care. Today, Alex Dasteel is 4 1/2 years old and healthy, but because he was born so early, his chances of severe mental retardation were great.

Now Dasteel is pregnant with a second child. She and her husband want to take every precaution against another early delivery. Her doctor has prescribed in-home uterine monitoring, which obstetricians believe can detect contractions that the mother cannot feel. But the family’s insurance company, Blue Shield of California, will not pay for the monitor and required nursing support--a service that averages $5,175 per patient but can reach $10,000.

The company that makes 70% of the uterine monitors used in this country, Tokos Medical Corp. of Santa Ana, has offered to ask Blue Shield to make an exception for Dasteel. If that does not work, Tokos said, it will extend credit to the Dasteels.

“Paying the bills is not going to be easy for me--I’m in real estate, need I say more?” said James Dasteel, the father. “But what are we going to do? I don’t feel like we have any choice.”

Fifty of the nation’s major insurance companies will reimburse the cost of uterine monitors for high-risk pregnancies. They point to studies saying the monitors help detect early labor in time to prolong pregnancy. Beyond humane concerns, the monitors can hold down the cost of hospital care for premature babies; Alex’s first weekend in intensive care cost $39,000.

Another 20 of the largest insurers refuse to pay for uterine monitoring. They are relying on an opinion by the influential American College of Obstetrics and Gynecology, which terms the monitor experimental and maintains that there is no conclusive proof that it can prolong pregnancy.

The group also said the monitor’s use is spreading to women unlikely to deliver prematurely. That wastes money at a time when health costs are soaring, leading members of the obstetricians group argue, and it could needlessly harm women who are treated with drugs in conjunction with the monitor.

Tokos is caught in the middle of this controversy, along with people such as the Dasteels. The company worked for six years to persuade those 50 insurers who do pay for the monitors, and Tokos has a full-time staff of 15 people who visit insurance companies across the country.

But Tokos has recently received a challenge from a very influential obstetricians group, which is making a grass-roots pitch to other physicians by publishing its doubts about the device in the New England Journal of Medicine, the largest-circulation U.S. medical journal.

Tokos, which receives 90% of its revenue from the lease of uterine monitors and accompanying nursing services, watched its stock dip 13.5% in early November after the letter appeared in the journal.

“It’s been a very significant battle over the years, any innovation is,” said Nicholas Mione, chief financial officer for Tokos. “We figure it’s a 10-year process, and we’re six years in.”

The company’s stock has since risen again, to $43.50 at the close of business last week, buoyed by a general interest in biomedical stocks in late December and January, company officials said. That’s near its 52-week high of $46.25.

The home uterine monitor is a smaller version of a monitor commonly used in hospital labor rooms. Expectant mothers strap on the beltlike device twice a day for an hour each time to record contractions. The time of day differs with each woman. Then they transmit the information over telephone lines to Tokos nurses, who can recommend a change in bed rest or drug therapy or a visit to the doctor if needed.

Behind the objections to the uterine monitor lies a fear of repeating the painful lessons of the fetal heart monitor. That monitor, an electronic listening device, was developed in the 1960s for use in hospitals during high-risk deliveries. But it was soon embraced for use during all births, as patients demanded the best available care.

Two decades after the heart monitors were adopted, studies showed that they did not improve the outcome of a pregnancy more than the regular use of a stethoscope. In fact, one study published in March, 1990, found three times as many cases of cerebral palsy among infants who were born when fetal monitors were used. The reasons for this are unknown.

By the time the studies debunked the heart monitors, the electronic devices were already widely used. And once a technology is widely accepted, it is nearly impossible to withdraw it for further study.

A criticism of today’s home monitors is that clinical studies have failed to use a control group of high-risk women who receive no special treatment at all. So doctors are unsure whether it is the Tokos device or daily contact with a nurse that determines whether early deliveries are averted.

“The problem in America in 1992 is you’re not going to be able to do that study, because you’re going to have people clamoring for that device,” said Dr. Richard Meidell, director of the neonatal intensive care unit at Western Medical Center-Santa Ana. Obstetricians have challenged as inadequate the one study that purported to separate the use of the device from the effects of daily nursing care--the study the FDA used as a basis for its approval.

Moreover, America spends an average of $3,650 per birth--more than any other nation--and heart rate monitors only add to the expense, according to the BirthPlace, a birth center in Des Moines, Iowa. At the first sign of “distress” on the fetal monitor, many doctors would wheel a woman into the operating room for a Cesarean birth, which would add $3,000 or more. Women who are monitored have roughly double the Cesarean rate of women who aren’t.

With the FDA’s 1990 approval of the home uterine monitor for high-risk pregnancies, some obstetricians worry that soon it too will be widely used, although 70% of pregnancies are considered normal.

While there are some potential risk factors, there is no sure way to tell who might be at risk for delivering a baby prematurely. In a review of seven studies to evaluate patients at risk, all but one was correct for just one out of five women, the obstetricians group has noted.

Overuse of the device is not only a cost concern but also a health issue. The more the device is used, the obstetricians group argues, the higher the chances of a misdiagnosis of premature labor. Women treated for premature labor run the risk of a bad reaction to the labor-delaying drugs. The drugs can cause water on the lungs, metabolic abnormalities and, in rare cases, death.

“It’s a cascade,” said Dr. Benjamin Sachs, chief of obstetrics and gynecology at Beth Israel Hospital in Boston and one of the authors of the letter to the New England Journal. “We can’t show what the risks are, nor can we identify who should use it. I hope that the education of our colleagues can slow down or reverse the introduction of this technology.”

But Dr. Peter Anzaldo of St. Joseph Hospital in Orange, the obstetrician who prescribed the monitor for Dasteel, said times have changed since the days when insurers would embrace a new technology as readily as they did with the fetal heart monitor. “I am constantly on the phone defending my position” to insurers, he said.

One observer suggested another reason physicians will probably object to home monitors: They hate to be replaced by a machine.

“There’s a fear on the part of the obstetrician,” said Dorothy Ryan, a stock analyst with Robertson, Stephens & Co. of San Francisco. “There’s a fee (paid to doctors) of $2,000 to $2,500 for prenatal care and delivery, and they can’t understand why a Tokos would get $5,000 to monitor a pregnancy.” Tokos, which is the only supplier of home pregnancy monitoring devices with FDA approval for home use, estimates the potential market for the device at $3 billion. In 1990, the companies selling home monitoring services altogether had sales of $105 million, according to a report by Villwock Action Research, a Dallas-based investment adviser.

In 1990, Tokos’ share of the business was $75 million. The remainder was shared by the company’s two competitors--privately held CareLink of Laguna Hills and Healthdyne Inc. of Marietta, Ga., which reported device-related sales of about $25 million.

Tokos said close to 10,000 obstetricians--roughly one-third of the U.S. total--have used the device, as have 80% of perinatal doctors, who specialize in high-risk pregnancies. In all, more than 75,000 women have used the device.

In defense of the technology, Tokos points to its analysis of 22,001 patients who developed premature labor. When the first episode of labor occurred between the 20th and 24th weeks, early detection and treatment prolonged the pregnancy for an average of 13.1 weeks. If the babies had been delivered when labor began, most would have died.

When labor began between 25 and 29 weeks, the pregnancy was prolonged by 9.1 weeks on average; when it began between weeks 30 and 34, the baby was kept in the womb an average of 5.3 more weeks with such medical intervention as bed rest and tocolytic drugs.

That can buy precious time for the baby’s respiratory, nervous and digestive systems to develop. And, as Tokos officials point out, healthy babies have a better chance of becoming healthy, productive adults. Premature birth causes more serious health problems and disabilities than any birth defect.

The company also makes an effective argument that its device saves medical dollars. Each day a baby spends in the hospital means an average bill of $1,500; it costs $900 a day to hospitalize a mother. If the mother is home, pregnant with the baby for an extra week, that more than pays the cost of Tokos monitoring.

The firm estimates that it has helped save about $586 million that would have been spent in initial newborn care since it began marketing the monitor in 1985.

“We obviously believe we’re bringing real value to the marketplace,” said Robert Byrnes, chairman and chief executive of Tokos. “There’s an economic gain for us as well as a psychic gain (that comes) from making a positive difference.”

Tokos, which is derived from the Greek word for childbirth, was founded in 1983. The company spent two years in clinical trials before it began marketing its uterine monitoring device. It applied for FDA approval and was rejected.

At about the same time, a small Atlanta-based company, Physiologic Diagnostic Service Inc., was setting up a study in Cambridge, Mass., that would eventually satisfy FDA criteria.

“We were building a market, negotiating (terms that would satisfy) the FDA,” recalled Kathy Gookin, Tokos’ vice president of clinical research, “and PDS, this tiny company, had designed a very simple study around using the device only.”

In 1988, the FDA ruled that the question PDS was studying was the one the agency wanted answered before it would approve the device.

In the PDS study, women using monitors sent information to nurses, but the nurses did not respond with medical advice. Premature labor was detected before two centimeters dilation of the cervix (which is an indication of impending delivery) in 73.1% of the monitored group, as opposed to 27.5% of the unmonitored group, whose only treatment was daily contact with a nurse.

Tokos bought PDS in August, 1990, for $31.4 million, just one month before the device was approved by the FDA.

But scientists disagree about the value of the PDS study, the results of which was were published in October in the medical journal Obstetrics and Gynecology.

The study was poorly constructed from a statistical standpoint, critics argue, including only about 40 women in each group. And the doctors who placed women in the high-risk category were the same ones who monitored their care, so they had an interest in proving their choices correct.

Also, Tokos donated monitors for the study, which is not an unusual occurrence but which raised questions of researcher objectivity.

“A lot of studies are funded by drug companies and manufacturers, it’s true,” said Dr. Seymour Adelson, senior medical consultant in the department of medical policy interpretation for Blue Cross/Blue Shield of Michigan. “But you always have to suspect these studies have an inherent bias.”

Absent a consensus on the monitoring device, individual physicians and insurance companies find themselves setting their own policies.

Blue Cross/Blue Shield of South Carolina has been funding the monitors for two years. It requires a patient to have a past history of premature delivery or a sign that the current pregnancy may end prematurely.

“We felt that way we could always demonstrate savings,” said Ashby Jordan, vice president of medical affairs. “It’s cheaper than the patient staying in a hospital. We don’t approve it for someone the doctor just feels is at risk.”

Other factors that define a high-risk pregnancy--the mother is carrying more than one baby, is bleeding out of control or has an incompetent cervix--do not justify the monitor. Dasteel has an incompetent cervix, common among daughters of women who took the anti-miscarriage drug diethylstilbestrol, or DES, while pregnant.

Jordan’s decision was based, in part, on a study that showed that of 541 high-risk patients, 40% of women who had two risk factors never went into premature labor. So, if all women who are at risk were monitored, 40% of monitoring money would become preventive medicine.

By contrast, Jordan said, one premature birth his company covered cost more than $1 million.

Adelson, who directs policy for Blue Cross/Blue Shield of Michigan, denies payment for the monitors, relying on the opinion published by the American College of Obstetrics and Gynecology in November, 1989.

“Most of the medical world is still sitting in judgment,” Adelson said. “There is precious little in the literature. Certainly there is theoretical justification, but there is not any real, hard evidence that it has proven itself.”

One physician who was unconvinced of the device’s effectiveness, Dr. Donald Dyson, conducted his own study of mothers carrying twins. He is setting up an independent monitoring center for Kaiser Permanente’s Northern California region--which will not rely on Tokos’ nursing services.

Dyson said critics of his study say it does not hold true when there is just one baby.

“It’s exceedingly difficult to design studies to convince someone who does not wish to be convinced,” Dyson said.

Battle for Credibility

Tokos Medical Corp. has spent six years trying to convince insurers that use of its in-home uterine monitor by women with a high risk of premature deliveries will save them money. So far, 50 of the 70 largest insurers have decided to pay for the costly care, which averages $5,175 per patient.

Monitoring

The uterine monitor is attached to a belt and worn low on the waist. A pressure-sensitive pad detects motion and pressure within the womb. Changes are measured and recorded electronically, and the data is stored in digital form for later transmission to a central nursing station via telephone lines.

Source: Tokos Medical Corp.

Gestational Age at Delivery

Babies delivered more than four weeks before the normal gestation period of 40 weeks require hospitalization, as do the mothers. The average length of hospital stays dramatically increases for deliveries before 34 weeks.

Gestational age at delivery Avg. hospital days (in weeks) Mother Infant 28 17.7 64.0 29 25.3 36.5 30 17.7 24.7 31 10.5 33.4 32 12.1 27.3 33 6.3 23.1 34 7.0 10.0 35 4.0 6.0

Identifying Women at Risk

A number of factors have been identified as increasing the probability of premature deliveries. Here are the five most likely to result in early deliveries:

Probability of Risk Factor Early Delivery Triplets, quadruplets, etc. 75-100% Two or more previous pre-term births 70% Pre-term labor, current pregnancy * 70% Twins 50% Previous pre-term delivery with pre-term labor 30%

* after being halted by labor-inhibiting drugs

Source: “Preterm Birth: A Puzzle Worth Solving,” John C. Morrison, MD, University of Mississippi Medical Center

Although premature deliveries account for only 10% of the 3.9 million births annually in the United States, the cost for intensive care alone for premature infants adds up to more than $5 billion a year.

Half of pre-term births occur in women who do not exhibit the high-risk factors.

Non-high risk women:

Full term: 85%

Pre-term: 5%

High-risk women:

Full term: 5%

Pre-term: 5%

Cost-Effectiveness of Monitoring

A study of 541 women at high risk for premature delivery found average savings per patient of more than $15,000 with the use of devices to monitor uterine contractions, even though 40% of the women never experienced pre-term labor and had full-term deliveries. The cost savings resulted from lengthening the pregnancies, thereby reducing hospital time.

Cost With: $13,629

Cost Without: $28,955 Source: Villwock Action Research, an investment newsletter