In vitro fertilization, or IVF, is a costly way to build a family. Many health insurance policies don't cover it. Each try costs $10,000 to $12,000 or more -- and only about one-third of women get pregnant on the first try. Once a couple has spent their life savings, or perhaps run up all their credit cards, on one, two or more attempts, there may be no money left.
In response, some fertility clinics have begun to offer guarantee or "shared-risk" programs: If you don't have a baby, you get most of your money back. But there is a catch: If you do get pregnant and give birth, that could wind up being one expensive kid.
In addition, some observers question the motives and ethics behind the baby guarantees. Are the deals always in patients' interest? Or does the money riding on the outcome sway clinics to implant more embryos than advisable? So far, there's little evidence to bear out such fears.
"My sense is that the shared-risk programs are performing in a very ethical and useful way," said John Robertson, a law professor specializing in bioethics at the University of Texas School of Law and chairman of the ethics committee of the American Society of Reproductive Medicine. "The main issue is that the couple be informed about the risks and benefits, about what their chances are of getting pregnant and having a baby on the first try. They're in essence buying insurance. They need to be informed about whether it's a good deal."
Leanna and Dan Curry, of Oak Hill, Va., wanted to start a family as soon as they got married in 1996. They were both healthy and didn't expect getting pregnant would be a problem for Leanna. But it was. After three years of trying, they decided to take the high-tech route.
Leanna and Dan both had health insurance, but their policies did not cover IVF. In 1999 they signed up for the shared-risk program at Shady Grove Fertility Reproductive Science Center in Rockville.
The Currys paid an upfront fee of $20,000 -- roughly what it would have cost them to make two IVF attempts using the conventional pay-as-you-go approach. For that fee, Shady Grove Fertility agreed to attempt up to three "cycles" of IVF on Leanna, plus additional attempts with any frozen embryos left over from these IVF cycles. Everything was paid for upfront except medications.
The deal was that if Leanna became pregnant and delivered a baby, Shady Grove Fertility kept the whole fee.
If she didn't have a baby, they'd refund the $20,000.
Either the couple or the clinic could halt the program at any time, and the couple would be refunded the money. But no one expected that to happen. All Leanna's screening tests had come back normal, and she was considered a good candidate.
But it wasn't easy.
Leanna didn't respond well to the medications that were supposed to trigger her egg production, so doctors had a very limited number of eggs to work with. Then the doctors found a tiny fibroid tumor in her uterus, which took two surgeries to correct -- but fortunately her health insurance covered that.
With each IVF try, the doctors altered the protocol a little, changing the sequence or dosage of drugs. But nothing worked -- after three cycles, Leanna still wasn't pregnant. The couple was devastated. The doctors offered to try one more time, for no additional cost. And the fourth attempt worked. Nine months later, Leanna delivered a healthy baby girl.
The whole experience was "a roller coaster of surprises," said Leanna. But she expressed relief that the financial aspects were taken care of upfront. "We cleared out our life savings, but at least we could get past that" and just concentrate on getting pregnant, she said.
"I'm sure they lost a boatload of money on us. . . . If we'd had to pay a la carte, we wouldn't have been able to fight so long to get the results. [The program] allowed us to endure the game. Each time, when we wouldn't get pregnant, we could just say, 'Oh. well, we have X number more tries.' "
A year after their daughter was born, the Currys decided to try again. Once more, they bought into the shared-risk program, braced this time for a long, hard road to pregnancy. Instead, Leanna got pregnant on the first cycle -- with twin girls. But they have no complaints: "It was a great return on the money," said Leanna. "We'd thought we'd be in for several cycles. We were thrilled not to have to go through all the treatments, all the highs and lows."
Playing the Odds
That's the nature of the gamble in shared-risk programs: Easy patients subsidize the tough ones. But not everyone agrees that the money-back plans are a boon to fertility-challenged couples. Shared-risk programs "have a lot of selection criteria and a lot of exclusion criteria -- they're cherry-picking the [women] most likely to get pregnant," said reproductive endocrinologist Rafat Abbasi of Mid-Atlantic Fertility Centers in Arlington, who is also a clinical consultant to the National Institutes of Health. Mid-Atlantic does not offer a shared-risk program.
"Most women get pregnant in one or two attempts . . . but among the cherry-picked ones," said Abbasi, "there's an even higher number who get pregnant the first time. But they're paying for three or four or five attempts. . . . The 28-year-old who pays $28,000 and gets pregnant in one try is subsidizing the 38-year-old who takes four times."
Another problem, said Abbasi: "In these programs, doctors tend to transfer higher numbers of embryos, increasing the risk of multiple pregnancies."
While that concern has been raised in the past, an investigation by the ethics committee of the American Society of Reproductive Medicine found no evidence of more embryos' being transferred in shared-risk patients, according to its 1998 position paper "Shared-Risk or Refund Programs in Assisted Reproduction."
In fact, the committee concluded that "the shared-risk form of payment for IVF is an option that might be ethically offered to patients without health insurance for IVF" if patients are properly informed of the costs, criteria and chances of success in the program.
'Put Up or Shut Up'
Shady Grove Fertility was a pioneer in the shared-risk movement when it introduced its plan in 1993, said Robert Stillman, a reproductive endocrinologist there.
The program, he said, "functions as a self-insurance trust. It's an option for those without insurance. I call it the 'put up or shut up' plan. In many forms of medical practice, it's impossible to have fees based on outcome of service. But here, you either have a baby or you don't. Some plans are based on whether the woman gets pregnant" -- not ideal, since 16 percent of pregnancies caused by assisted reproductive technologies end in miscarriage, according to the Centers for Disease Control and Prevention -- "but ours is based on a baby."
Stillman said he'd prefer to do away with shared-risk plans -- if there were something better to take their place. "If you had full insurance reimbursement [for IVF], you could eliminate all shared-risk programs," he said.
His proof? Most of the group's shared-risk patients come from Virginia and the District -- jurisdictions that don't mandate coverage for IVF procedures. In contrast, he says, "Maryland is a partially mandated state -- if you have more than 50 employees, aren't federal, fulfill medically reasonable criteria, and your employer wants coverage for IVF, the insurance company can't refuse to cover it."
Shady Grove Fertility's brochure lays out the costs for IVF: A single cycle of IVF, on a pay-as-you-go basis, costs $8,500 plus a substantial additional amount for the required drugs. It's an additional $1,350 per cycle to freeze embryos, and $2,150 for each implantation of thawed embryos.
Under the shared-risk program, the patient pays $20,000 up front, which is a global fee covering all IVF, embryos freezing and implantations. (Prices are higher if additional services, such as using donor eggs, are chosen.) After Leanna Curry's experience, the clinic increased the number of cycles covered from three to four -- and now is changing it to an unlimited number, provided the clinic's doctors agree that continued attempts are appropriate. Most patients, though, will choose the money-back option rather than go four or more cycles, admits Stillman.
"If the patient gets pregnant on the first cycle, they pay more than they would for fee-for-service," said Stillman. "At the second cycle, it's about break-even. At three or four, it's a savings. Our risk is that, if the patient doesn't get pregnant, we've spent our resources without remuneration."
Medication costs can run an additional $2,500 to $4,000 per cycle. Some health insurance plans cover the drugs, even if they don't pay for the IVF procedures.
Stillman denies any cherry-picking, saying his clinic's criteria for participation in the shared-risk program are "relatively liberal": The woman must be younger than 39 (unless using donor eggs), "with basically normal hormone levels and a normal uterus." A physician committee at the clinic must approve any applicant to the program, but the center claims that 70 percent of all the practice's patients qualify.
Stillman maintains that shared risk allows doctors to implant fewer embryos per cycle than fee-for-service plans -- because it's not a one-shot deal. Shady Grove Fertility averages 2.1 embryos implanted per cycle, which he says is one of the lowest rates in the country.
Want an Extended Warranty?
A somewhat different approach to "a baby or your money back" is, in essence, a warranty program.
Advanced Reproductive Care (ARC) is a network of 73 clinics in 38 states, including Virginia and the District. Over the past three years, the group has sold money-back guarantees to more than 1,000 patients, according to founder G. David Adamson, a reproductive endocrinologist.
Here's how it works: A patient buys a three-cycle package, the price of which is determined by age and other variables. For example, a healthy 33-year-old woman might pay $20,640 for three IVF attempts, plus up to three attempts with frozen embryos. For a warranty, she would pay an additional $8,075.
ARC pays the woman's clinic a portion of the $20,640, whether or not the patient gets pregnant.
Should a warranty-carrying patient fail to have a baby, she would receive her $20,640 back from ARC, though she would forfeit the $8,075. In other words, the attempts will have cost her $8,075, instead of $20,640 without the warranty -- or about $25,500 if she paid for three attempts individually. (Again, the cost of medications isn't included in this example, although other refund plans do cover drugs.)
What sets this kind of plan apart from shared-risk plans is that the clinic receives the same fee regardless of whether a baby results, said G. David Adamson, a reproductive endocrinologist who founded the network. The ensures that doctors' decisions are based on good medicine, not remuneration, he said. ARC offers financing, which Adamson hopes will encourage couples to try IVF sooner -- while their chances of getting pregnant are better. Recent CDC data show that in IVF with nondonor eggs, 35 percent of women under 35 get pregnant in one cycle. By 38 to 40, the rate drops to 20 percent. At 41 to 42, it's 10 percent, and over 42, it's only 4 percent.
Perhaps if they don't have to save up $20,000 first, Adamson figures, they can get their family started earlier.
Fertility Centers that have shared-risk or warranty plans include:
* Advanced Reproductive Care (member practices in the District and Virginia), 888-990-2727.
* Shady Grove Fertility Reproductive Science Center (locations in Rockville, Annapolis, Columbia, Frederick, Annandale, Fair Oaks and the District), 888-IVF-0500.
* George Washington University IVF Program (locations in the District, Rockville and Vienna), 202-741-2520.
* Dominion Fertility & Endocrinology (locations in Arlington, Reston, Loudoun and the District), 703-920-3890.
* Washington Fertility Center (locations in Annandale, Reston, Leesburg and Hagerstown; opening soon in Rockville), 703-658-3100.
* The Muasher Center for Fertility and IVF, Fairfax, 703-876-6311.
* Virginia Center for Reproductive Medicine (locations in Reston and Hagerstown), 703-437-7722.
* Genetics & IVF Institute (locations in Fairfax, Ashburn and Gaithersburg), 800-552-4363.
Lisa Barrett Mann last wrote for the Health section about health insurance options for new college graduates.