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Law Sets Up Hurdles to Care

Posted on: Sunday, 29 January 2006, 15:00 CST

By Dion Lefler, The Wichita Eagle, Kan.

Jan. 29--to care

His body ravaged by bladder cancer and chemotherapy, John Bowles is a victim of a state law that could kill him -- or you.

But because of his case, the law could change.

After Bowles was diagnosed with cancer in late September, his insurance company refused to pay for drugs his doctor recommended. Coventry Health Care of Kansas denied the treatment as "experimental."

A state medical review ruled in December that the treatment is not experimental and that if Bowles received the treatment, his insurance company would have to pay for it.

But by then, Bowles had started on another course of treatment, and it was too late to go back to the originally prescribed drugs, his doctor said.

What makes Bowles' situation particularly frustrating is that future patients with the same disease, wanting the same treatment, could be made to go through the same process all over again.

Under state law, the decision in Bowles' case applies only to him.

Bowles' oncologist, Shaker Dakhil, said he challenged the experimental designation because he believes Bowles' insurer was pressuring him to use a cheaper treatment.

The company's denial was "basically delaying tactics to inhibit physicians from prescribing these drugs," said Dakhil, president of Wichita-based Cancer Center of Kansas.

James Utley, medical director for Coventry, vehemently denied that cost was a factor.

"We spend thousands and thousands of dollars on oncology treatment every day," Utley said. "If it's an effective treatment and it's one that's clearly supported by the literature, we're glad to approve it."

Work to be done

Bowles' case has highlighted a potential shortcoming in state law, said Sen. Ruth Teichman, R-Stafford, chairwoman of the state Senate Financial Institutions and Insurance Committee.

After learning of Bowles' plight from The Eagle, Teichman is considering a bill to end the case-by-case approach to experimental drugs.

Teichman said once the state has gone through a formal review process and found that a treatment is not experimental, other patients should be able to use it.

At present, the results of state reviews on experimental drugs are confidential.

The Eagle learned about Bowles' case only because he authorized his doctor and Coventry to release his medical information.

State Insurance Commissioner Sandy Praeger said she agrees that there are problems with the review process -- particularly that it takes too long for patients who are gravely ill.

In Bowles' case, it took 2 ½ months to get a final decision. During that time, he had to be put on an older treatment that seldom completely cures cancer and is notorious for debilitating side effects.

Praeger said part of the problem is that her office can't intervene until after the patient has exhausted all appeals within the insurance company.

After that, the company has five working days to provide the paperwork to the insurance department. The department has 10 days to prepare the file for review, and the reviewing physician has 30 days to study the case and make a ruling, spokeswoman Charlene Bailey said.

In Bowles' case, the insurance company's two-level internal appeal process took 10 days.

Praeger said she is working on a bill -- separate from Teichman's efforts -- to streamline the process.

The bill would allow patients to waive a second insurance company appeal and go straight to a state review. In addition, it would give patients the right to have legal representation in the insurer's second-level appeal, Bailey said.

'Kansans die'

The proposed changes in law have the enthusiastic support of state Sen. Phil Journey, R-Haysville, who recently underwent surgery for bladder cancer.

He said that when a state medical review declares a treatment not experimental, "It makes absolutely no sense to me that it should not apply to all subsequent cases involving that particular drug for that disease."

As to the time needed for reviews, Journey noted that Bowles filed Oct. 18 and didn't get a decision until Dec. 29. "That's unfortunate," he said. "It should have happened before Halloween."

He offered to introduce Praeger's bill.

"If they come to me with a draft, I'll be glad to submit it for legislative review," he said. "Kansans die as time goes by."

Cheryl Dillard, Coventry's director of governmental and public affairs, said the company hasn't yet formed a position on the proposed legislation.

"Before we would take a position on this whole idea of creating precedent, we'd like to see actual language in legislation," she said.

But at present, "we actually like the system the way it is now," she said. "We think it's fair to our members and providers."

Utley said Coventry's two-level appeal process is more extensive than the state review.

In the first level, the appeal is reviewed by an independent physician. If it goes to the second level, it's reviewed by a panel of three outside experts, he said.

The state review is done by a single physician.

Jumping too quickly to pay for new treatments can do more harm than good, he said.

"To pay for unproven therapies not only adds to the rising cost of health care, but obviously it also runs the risk of exposing the patient to therapies that are less effective or even possibly harmful in light of the standard therapies that are available," he said.

Small number of reviews

The insurance department receives about 1,300 health insurance-related complaints each year.

But there is no statistic on how many of those complaints challenge insurance company decisions that a treatment is experimental.

Steve O'Neil of the Kansas Insurance Department said only two situations lead to a state medical review: denial of a claim because a treatment is deemed experimental and denial of a claim because a treatment is deemed not medically necessary.

About 50 cases go to medical review each year. Patients win about half the time, O'Neil said.

He said he's not aware of a case in which the department has had two medical reviews on the same drugs for the same condition.

Dakhil, Bowles' oncologist, said that the small number of reviews indicates to him that physicians aren't taking cases that far.

With no way of knowing whether the state has already reviewed a treatment, doctors often will simply accede to the insurance company's denial and move on, he said.

"Physicians don't have the time to do a full literature review for every patient," he said.

Narrow approval

Before a drug can be sold in the U.S., manufacturers must put it through a series of tests to prove to the Food and Drug Administration that it is safe and effective in treating at least one disease.

Because the process is long and costly, manufacturers usually seek approval for only one application for each drug.

However, doctors and researchers often find that a drug approved for one disease is effective for other ailments as well. That's called "off-label" use.

When enough evidence has been compiled to demonstrate a drug is effective for a particular disease, it is listed in national compendia that guide physicians' decisions on prescriptions.

Once a treatment is listed in the compendia, the law requires that programs such as Medicare and Medicaid pay for them.

Dakhil said the proposed state law changes are a good start, but he'd like to see Kansas follow the federal lead.

"If a drug's in the compendia, then it's been tested nationally," he said. "It's not experimental anymore, and they should cover it."

But Utley said the fact that a physician prescribes a drug "does not make it a covered benefit."

In Bowles' case, "Whether or not you proceed with this treatment is a decision between you and the member," Utley's letter said. "This determination only indicates Coventry Health Care will not be responsible for charges incurred."

Denial overturned

Dakhil originally prescribed Bowles a combination of three drugs -- carboplatin, Gemzar (gemcitabine) and Taxol (paclitaxel).

Dakhil pointed out that all three drugs are in the compendia for treatment of bladder cancer.

Utley acknowledged that. However, he cited a compendium of the American Society of Health-System Pharmacists, which says the combination treatment Dakhil proposed is still being evaluated.

In the letter denying Bowles' appeal, Utley wrote that there has not been an advanced study of the combination Dakhil prescribed.

"In fact, this combination is in a current study which is a Phase II trial," the letter said. "As a Phase II trial, it is by definition investigational/experimental and as such is not a covered benefit."

The state review, by the Kansas Foundation for Medical Care, disagreed.

"These drugs are all documented as having significant activity in bladder cancer," the review said. Dakhil's treatment plan "is rational and within the standard of practice."

"The three-drug regimen is not experimental and has proven activity in bladder cancer. The treatment should not be denied," the review concluded.

Utley and Dillard said Bowles was offered the chance to get the drugs from a clinical trial but declined.

"It is our understanding from his physician that Mr. Bowles was offered the opportunity to participate in this trial but he declined to do so," Utley said.

"That's not true," responded Nita Stone, Bowles' daughter, who has managed much of his medical care.

She said he was rejected for the trial because his urologist had removed some of the cancer from his bladder and prostate gland.

Dakhil, who is helping conduct the clinical trial, said he tried to explain to the insurance company that the study is not about the effectiveness of the medicines. It is about whether patients who have already had the treatment should have their bladders removed as well.

Bowles didn't qualify for that. "They (Coventry) are just trying to divert the discussion," Dakhil said.

A question of cost?

Bowles received one round of the treatment Dakhil prescribed before the insurance company denied the claim. It cost $12,300.

A full treatment of three rounds would have been about $37,000, Dakhil said.

By contrast, the treatment the insurance company allowed cost about $10,000, Dakhil said.

Dakhil said he would have paid the cost of Bowles' initial treatment if the state ruling had gone in Coventry's favor.

But neither he nor the Bowles family could afford the risk of having to pay the entire $37,000.

Bowles, who is retired, is insured with Coventry through the city of Wichita because his wife, Nancy, is a service officer in the Police Department.

His treatment would have cost nearly her entire annual salary.

Mayor Carlos Mayans said he plans to look into the case.

As chairman of the state House Insurance Committee in 1998, he helped pass a law to prohibit insurance companies from declaring off-label use of drugs for cancer patients as experimental treatment.

It is not clear why that law wasn't invoked in Bowles' case.

Mayans said it was his intent as a legislator that it would cover such cases.

Drugs show promise

No one knows for sure whether Dakhil's proposed treatment would have been more effective than what Bowles received, an older drug combination: methotrexate, vinblastine, adriamycin and cisplatin.

When Bowles received the initial course of the treatment Dakhil preferred, he did not experience significant side effects, as he has with the four-drug cocktail.

"I was tired, but in a day or two, I was back up kicking around pretty good again," he said.

Trials of the drug combination Dakhil proposed are promising.

A study published in the Journal of Clinical Oncology in 2001 found that of 47 patients with advanced bladder cancer, 68 percent responded to the treatment, and nearly a third had a total remission of their cancer.

For future patients

Of course, all this is more than academic to Bowles and his family.

These days, Bowles, 67, is a shadow of the once-hardy individual who worked more than 50 years in the service station industry and ran his own Fina station.

He used to take long walks. Now he can barely get around his house.

His hands shake, and he wears a cap, even indoors, because of hair loss caused by the chemotherapy.

He has developed a fungal infection of the mouth and throat -- a common side effect of the four-drug cocktail -- that makes it difficult for him to eat or talk.

For Bowles and his family, it's now a matter of wait and hope -- hope that the drug combination was effective and that the spots on his liver are harmless fat deposits and not a spread of the cancer.

"I don't know where we're at right now -- all I know is no more chemo," Bowles said. "I feel like I spent four months and I haven't gained a thing."

His wife said she can't help but think that things might have been different.

"I really believe if we'd been able to complete the treatment that was prescribed to start with, it would have been all right by now," Nancy Bowles said.

Another hope for the Bowles family is that their ordeal might change things for future cancer patients.

Stone said she's heartened that legislators are taking an interest in her father's case.

"It would be nice to know that through his trials, somebody else would be helped," she said.

NOW YOU KNOW

PROPOSED CHANGES TO TREATMENT LAW

-- State Insurance Commissioner Sandy Praeger is planning to introduce a bill that would streamline the process for patients to receive a state medical review when their insurance company has denied a treatment as experimental. It would allow patients to waive a second appeal to their insurer when a claim is denied and expand patients' right to legal representation.

-- State Sen. Ruth Teichman, R-Stafford, may introduce a bill to make state medical review rulings of whether a treatment is experimental apply for all patients with the same disease. Under current state law, the decision applies only to the patient whose case was reviewed.

Reach Dion Lefler at 268-6527.

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Copyright (c) 2006, The Wichita Eagle, Kan.

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Source: The Wichita Eagle (Wichita, Kan.)

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