Military Insurance Says 'No' to Baby Helmets

Feb. 9, 2010— -- Katherine Regalado, 28, only saw the adorable baby smiles and a new older brother's doting attention to her baby Isaiah this summer. Yet, when Isaiah reached 4 months, her pediatrician noticed a problem she had missed.

Like many babies at birth, Isaiah's skull was misshapen. Only Isaiah's head never returned to a symmetrical shape. Doctors told Regalado, a stay at home mother of two living on Nellis Air Force Base, that the distortion had spread so much that it could soon leave Isaiah with a permanently asymmetrical head.

But Regalado was in for a bigger surprise. Her military insurance, TRICARE, wouldn't cover the orthotic helmet that experts promised would largely correct Isaiah's condition, called plagiocephaly.

"TRICARE paid for all the specialists leading up to the diagnosis until they ordered the treatment and then they [TRICARE] said no," said Regalado.

Regalado, whose husband is currently serving in Iraq, said she couldn't afford the $2,500 for Isaiah's helmet. Saving money over time wasn't an option either, since doctors told her children's skulls only stay malleable for the first year of life. After that, any misshapen bones would be permanent.

"They covered all the CT scans, the specialists," said Regalado. "I had no idea that they wouldn't be covering the helmet."

By the time Regalado heard that TRICARE did not cover the cranial molding helmet, she was lucky enough that a number of other military families had spoken out about the same predicament.

"I wasn't the first one to be denied," said Regalado. "I found other families online that were prescribed a helmet, and they said that they went to their military relief organizations, and so that's where I went to get a grant for my son."

Isaiah now wears his helmet, paid for by the Air Force Aid Society, for 23 hours a day, seven days a week. Isaiah's doctors prescribed the helmet for three months.

"He just got it last Friday," said Regalado. "We went for his first week checkup and we already saw significant improvement in the back of his skull."

Number of Babies With Flat Spots on the Rise

Experts say babies with Isaiah's condition used to be rare before the American Academy of Pediatrics' 1994 "Back to Sleep Campaign." The public education campaign has urged parents to position babies on their backs when they sleep to reduce the risk of Sudden Infant Death Syndrome (SIDS).

The campaign was successful in cutting SIDS deaths, but the number of babies with flattened heads increased.

Now specialists say they see many more babies with flattened skulls from the back to sleep position and often, these cases are not so severe.

"People estimate about 10-15 percent of all kids have it," said Dr. Mark Proctor, of the department of neurosurgery at Children's Hospital Boston. The majority of his cases are from babies who develop flat areas on their skulls while sleeping.

"Through our hospital, we see 50 to 60 cases of plagiocephaly a week."

Regalado said her son's condition developed from birth, not afterward. "When I went to the specialist, she explained that his head, the way the shape was, that you could tell that this happened in utero," said Regalado.

Whatever the cause, TRICARE has refused to cover the helmets for two reasons.

Why Insurance Won't Cover Some Claims

In a statement sent to ABCNews.com, TRICARE wrote "… the bottom line is that TRICARE cannot, by law, cover this device until there is reliable evidence to show that both of the following are true... 1) Positional plagiocephaly impairs a bodily function AND 2) Cranial helmets are safe and effective."

Since some of TRICARE's coverage is legislated by Congress, TRICARE says it must follow the law to limit coverage of cosmetic procedures and "we have not been able to find any scientific literature to show that positional plagiocephaly impairs a bodily function -- which makes it hard to document that the helmet actually improves a bodily function," it stated in its release.

However, TRICARE does cover some cosmetic procedures for select scenarios including breast reconstruction, and birth defects. TRICARE did not respond to further questions about whether Isaiah's condition could be considered a birth defect.

Insurance Coverage Looks to Studies to Approve or Deny Claims

"Even if there were literature showing that the natural history of positional plagiocephaly results in functional impairment of a bodily function (e.g., vision), there is still another obstacle to TRICARE coverage, and that is to show that the helmet is proven safe and effective in correcting or improving the bodily function," TRICARE said in a statement.

But specialists who treat plagiocephaly take a different view.

"It's not only for the beautification of the skull," said Peethambaran Ammanath, an orthotist at the University of Michigan Health System.

Ammanath said a few, small studies have linked severe plagiocephaly with developmental delays, and much stronger studies showing untreated plagiocephaly can lead to dental problems because the jaw is not aligned with the asymmetrical skull.

"There could be jaw problems, actually. Sometimes dental problems when the child is older," said Ammanath.

Doctors Say Treatment Works

Dr. Sherilyn Driscoll, director of pediatrics physical medicine and rehabilitation at the Mayo Clinic in Rochester, Minn., acknowledges some studies have shown medical problems resulting from a misshapen skull, as well as problems fitting children into bicycle helmets.

"There's a whole spectrum of how serious this could be," said Driscoll. "But it really is cosmetic and social. That's the main reason to treat it."

Driscoll, however, adamantly disagreed with TRICARE's conclusion that cranial helmets were not proven to be safe and effective.

"It is true that some studies dismiss helmets, but I would argue that those studies have some problems," said Driscoll.

Driscoll said she has heard the argument that parents can fix the flattened skull by repositioning. However, she said if the flat spots are bad enough, it is not practical to fix it with "tummy time."

"At a certain point, if the head shape is severely abnormal enough, that alone would not fix it and that child would need treatment," said Driscoll. "Mom and Dad can't sit there and reposition the baby's head every five minutes."

"The helmets work, there's just no question," she added.

Doctors Say Insurance Often Covers Baby Helmets

Proctor agreed. He recently wrote an extensive review article on the efficacy of the cranial helmets in an April 2009 issue of the Journal of Neurosurgery: Pediatrics.

Once fitted by individual medical centers, the helmets are now regulated by the U.S. Food and Drug Administration, and some private companies have begun to manufacture them, Proctor said.

The helmets function by providing a safe gap for the flattened parts of the skull to grow. Without continual pressure, Proctor said children's skulls will naturally grow back to a somewhat normal shape.

Proctor acknowledged that the gold standard for studies -- large, prospective and controlled studies -- looking into the helmets have not been completed.

But, "Cranial orthoses are routinely and effectively used to treat persistent severe deformational plagiocephaly," he concluded.

In fact, experts say most insurance companies cover the cranial helmets routinely. Neither Proctor, nor Driscoll, nor Ammanath say they have many problems getting insurers to cover the device.

"Even MassHealth, the state Medicaid, covers it," said Proctor. "There's no insurance in Massachusetts that doesn't cover it; the biggest problem I've had was with the military not covering."