Help for Health Care Coverage

Some medical device and drug makers are backing up patients looking to get treatments not currently covered by their insurance.

The Orange County Register

The last time Rebecca tried to end her life, she swallowed handfuls of the anti-depressants intended to rescue her from despair.

Medication doesn't entirely ease depression for the 55-year-old hospital case manager. So Rebecca wants a pacemaker-like device surgically implanted into her neck to regulate mood by sending pulses to the brain.

The device, known as vagus nerve stimulation or VNS, costs about $25,000 and works for 1 in 3 patients after one year, according to the manufacturer.

Those odds weren't good enough for her insurance company, Blue Cross of California, which, like a host of others, refuses to cover procedures it considers unproven or experimental.

But Rebecca isn't giving up on her quest to get her insurance company to pay for the treatment. And she has the backing of a $123 million company – the makers of VNS.

Rebecca hopes that if she receives VNS she can reduce or eliminate the medication that causes weight gain and dental problems. "If it worked for me over time, (insurance) wouldn't have to pay for all my medication or for my dentist." Rebecca says the implant would replace the need for her to take pills.


Cyberonics, a Houston-based company, is one of a handful of medical device and drug makers that offer would-be patients professional help battling their insurance companies for coverage of costly or controversial treatments. Manufacturers fill out insurance paperwork and offer sample letters of appeal. Nurses call to check in with patients and Web sites offer tips for remaining persistent.

"I don't know what else there is or any other thing that might help. I've tried everything," says Rebecca, an Orange resident who asked that her last name not be used because she fears professional stigma.

Device makers say they are simply empowering consumers to push for the best and latest in medical technology. But some medical ethicists and doctors worry that drug and device makers have a conflict of interest when they lobby other companies on behalf of patients and, not coincidentally, their own profits.

"We just feel sometimes patients are at a disadvantage when they have to fight up through the channels of the appeal process," said Lee Kaufman, director of case management for Cyberonics.

"It's not easy and it can be cumbersome. We're trying to get the treatment their doctors prescribe for them."

Mildred Cho, associate director of the Stanford University Center for Biomedical Ethics, said insurance companies should decide what procedures to cover based on reliable data over time, not as a result of pressure organized by device makers.

"It's clearly unusual for a manufacturer to be playing that role," Cho said. "Typically it's the health-care provider's role to get access to things they deem necessary for the patient. It seems like direct-to-consumer marketing in a way that's not appropriate."

But device makers hope that if they can show insurance companies that doctors and patients need their products, they will eventually allow widespread coverage.

Elise Anderson, a spokeswoman for Blue Shield, which along with Blue Cross, relied on the independent California Technology Assessment Forum to deny coverage for VNS, said the device fails to meet the standards of evidence-based medicine.

According to the technology report, there are other options for treatment-resistant depression including changing medication, psychotherapy and electroconvulsive or shock therapy. Shock therapy, a temporary measure, works for about 50 percent of patients and costs about $1,000 per session.

"We do the things that are in the best interest, safety, efficiency and effectiveness for our members," Anderson said. "Obviously costs are things that are under consideration. But the mission is to make sure that (treatments) are going to help the members."

Cyberonics says it also is working in the best interest of customers. Nationwide, more than 1,300 people have received the VNS device. Most of them have received claims assistance from Cyberonics' 70 case managers, who spend months working with each patient.

"There's cost involved, but we also know if we weren't doing this, the majority of these people would not have had surgery," Kaufman said. "It helps pay for itself."

That's been the case with Charite, an artificial back disc made by DePuy Spine, a division of Johnson & Johnson. The disc's effectiveness is debated among doctors and is the subject of a number of lawsuits from patients who say their pain has worsened. This spring Medicare, the federal insurance program, backed off plans to stop covering the disc because of concern about its durability.

Rich Toselli, vice president of clinical evidence and external relations, said nearly two years after the FDA approval, more insurers are paying for Charite.

He said in the past FDA approval was enough for Medicare and private payers, but with escalating health costs, they are demanding more studies and more information.

"To be honest, we as medical device makers are sort of learning our way through that," Toselli said.

While Toselli said the company seeks to educate insurance providers on the benefits of the product, they also are educating doctors and patients on the appeals process when coverage is denied. The company's Web site offers a bibliography of articles about Charite to "enhance your case," as well as addresses for contacting state insurance regulators.

"It's up to the patient to have the energy and persistence to go through the appeals process," Toselli said.

Dr. Charles Rosen, founder of the UCI Spine Center and a critic of Charite, said companies tout FDA approval as proof that a treatment should be covered. But he said federal regulators determine safety, while insurers also look at what's best medically.

"They are two different standards," Rosen said.

Another fight that could heat up over this month's approval of an eye treatment called Lucentis. The FDA signed off on a Genentechdrug that treats macular eye degeneration for about $2,000 a dose. It's intended to replace a similar drug made by the company that costs $17 a dose.

Genentech's Web site offers a toll-free hotline for people who have been rejected. But company officials said in a statement that they expect most patients will be covered through Medicare. Medicare officials said Tuesday they don't yet have a national policy on Lucentis.

Rebecca, the depressed woman from Orange, is still waiting to hear on her VNS appeal. Upon the advice of her Cyberonics case manager, she requested a letter from her dentist describing how her anti-depressants cause dry mouth and gum problems.

Cyberonics also employs a public relations firm, which has been seeking media coverage of insurers refusing to pay for VNS. An excerpt from a pitch says that denial of VNS by Blue Cross/Blue Shield destroyed a family's hope and sent the patient on "even more of a downward spiral."

Rebecca's psychiatrist, Gus Alva, said she takes three expensive medications that won't necessarily keep her out of the hospital again. He said it makes good economic sense for her insurer to approve VNS, which he said will cost less in the long run.

"If you tell me one-third of those individuals are going to be better, wow, that's huge," Alva said. "This is the sickest population. There's a great potential for success and we'll never know unless we actually try."