Woman's Move Triggers Loss of Coverage for Cancer Treatment

Woman's move triggers loss of coverage for cancer treatment [Milwaukee Journal Sentinel]

From Milwaukee Journal Sentinel (WI) (March 21, 2010)

Mar. 21--This article is part of an ongoing series about how money and conflicts of interest affect medicine and patient care.

For nearly a decade, Paula Oertel’s brain tumor was kept at bay by a drug that was not approved to treat her condition.

Then Oertel did something she never imagined would jeopardize her good health. She moved. Less than 30 miles -- from one county in Wisconsin to another.

The move triggered a review of her health insurance from Medicare, which eventually led to a loss of coverage, including the drug. And the tumor returned within four months.

What happened to Oertel stunned her doctor, Mark Malkin. Nothing he learned in medical school prepared him for what now is too often a sad and frustrating part of his job as a cancer specialist: fighting Medicare and private insurance companies over life-or-death decisions.

Doctors aren’t supposed to get emotionally involved in the cases of their patients, but tears well up in Malkin’s eyes when he talks about Oertel, the 40-year-old Oshkosh woman he has been treating for several years.

"I wish Paula would have a second chance," he said, choking up.

Oertel and Malkin are facing an ailment no drug can cure: a complex health insurance system that can overwhelm a seriously ill patient unequipped to deal with its complicated rules.

As America debates health care reform, cases such as Oertel’s illustrate how important decisions made between doctors and patients can be overruled, leaving patients with no options and the likelihood of dying in a matter of months.

Oertel, a shy, single woman, said she has tried to remain upbeat throughout the ordeal, but the decision to deny coverage for the drug that was keeping her alive made her mad.

"My attitude was pretty optimistic, even now," she said.

It started with aches

Oertel’s saga began about 12 years ago, when she was 29.

She began having headaches, stiffness in the neck and then had a seizure. A CAT scan done at a hospital in Oshkosh revealed that she had a tumor on the left side of her brain. The tumor was a glioblastoma multiforme, the same kind that killed Massachusetts Sen. Edward Kennedy last year.

Glioblastoma is highly malignant and the most common primary malignant brain tumor in adults, affecting about 9,000 Americans a year. On average, survival is about 15 months.

Oertel went to Froedtert Hospital in Wauwatosa for surgery, followed by radiation.

Within two months, the tumor had returned.

She had a second surgery and more radiation.

At the time there were no approved drugs for treating Oertel’s cancer, but as a last resort doctors decided to try interferon beta, a drug approved to treat multiple sclerosis that also had shown promise in treating cancer, Malkin said.

At best, it was a long shot, but Oertel began injecting herself with interferon three times a week.

And for nine years Medicare picked up the cost of the drug, which now runs about $8,000 a month, without questioning it, Malkin said.

Within a few months, something amazing happened: Oertel’s tumor disappeared completely.

"It worked beautifully," said Malkin, chief of neuro-oncology at Froedtert Hospital. "Her tumor just went away. She went into remission and stayed in remission for nine years."

During those years, brain scans were done every few months. Each time there was no sign of the tumor. Medicare continued to pay for the drug.

Malkin, also a professor of neurology at the Medical College of Wisconsin, said he has no doubt that the tumor’s disappearance was caused by the interferon.

"You don’t see spontaneous remissions with this disease," he said.

Staring at death

Now, Malkin estimates that Oertel has less than five months to live if she doesn’t get treatment with interferon.

She has been getting other treatments that are covered by Medicare, but the tumor remains.

It’s a perplexing system in which an approved drug that was largely ineffective in Oertel and costs $20,000 a month is covered, but an unapproved drug that worked and cost a fraction of that is not covered.

The prospect of getting Medicare approval for interferon is looking as grim as Oertel’s prognosis.

Not that Malkin hasn’t tried.

Over the last several months, Malkin has made calls and sent e-mails to a cast of officials, hoping that someone would be able to intercede and get the drug approved.

He has contacted both U.S. Sens. Herb Kohl and Russ Feingold from Wisconsin, Oertel’s congressman, Thomas Petri, her state senator and assemblyman, the state commissioner of insurance, the private company that administers Medicare in Oertel’s area and the Medicare office in Chicago -- all without success.

His office also contacted Biogen, the maker of interferon (Avonex) to see if it would supply the drug for free on the grounds of medical hardship. That too was denied because the drug was being used for someone who was not diagnosed with MS.

In a February e-mail to Petri’s office, Malkin said Oertel’s case illustrates some of the problems with health care now being debated in Washington.

"I have been practicing neuro-oncology for more than 20 years, yet decisions I wish to make on behalf of my patients are second-guessed or outright denied by representatives of insurance carriers who cannot even pronounce the name of the tumor I am treating," he wrote.

"My staff and I spend hundreds of wasted hours trying to obtain authorizations and appealing wrong decisions when we could be treating patients."

In a given year, Malkin said, his office appeals cases for dozens of patients. That is out of about 200 new brain cancer patients he sees each year.

Doctor/advocate

All over the country, cancer specialists are having to advocate more for their patients as a growing number of expensive drugs have come on the market in the last few years, said Allen Lichter, a physician and chief executive officer of the American Society of Clinical Oncology.

"It is part of the landscape now," Lichter said. "There is a great amount of effort (advocating for patients) today in oncology."

But the issues are not always clear cut.

On the one hand, he said, are doctors who may have a "boundless urge to save their patients."

On the other, are the insurance companies that must use good sense and not rubber-stamp every request for an expensive, unproven drug.

Insurers have to balance the needs of one patient against those of millions of people who pay premiums, he said.

"We wouldn’t be talking about this if these were $10 generics," Lichter said.

Cancer cases often are the most troublesome when it comes to cost vs. benefit.

In recent times, cancer medications have shot up 14% a year, according to a January study in Health Affairs.

It said drug companies have operated with the philosophy that they can charge whatever the market will bear, even if it is tens of thousands of dollars a year for a drug that provides modest benefit, often just a few weeks or months of increased survival.

The study found that 84% of oncologists now say patients’ out-of-pocket expenses influence their treatment recommendations, but only 43% regularly discuss costs with their patients.

Just last week a commentary in the Journal of the American Medical Association noted that cancer care costs have jumped from $27 billion in 1990 to more than $90 billion in 2008.

Still, Lichter said, given Oertel’s nine-year history of success with interferon, the interferon should have been approved.

Spokespeople for Medicare and Cigna, which handles some Medicare claims in Wisconsin, said they could not comment on Oertel’s case because of privacy rules.

In general, it is not unusual for companies that administer Medicare to reject a claim for a drug that is being used off-label (for a purpose it was not approved) or because it is not part of a plan’s list of covered drugs, said Elizabeth Surgener, a spokeswoman for the Center for Medicare and Medicaid Services in Chicago.

Even when there is some support in published medical research for using a drug off-label, it still may be denied unless the drug is on one of three lists, Cigna spokeswoman Lindsay Shearer said in an e-mail.

"Cigna and other Medicare Part D plan administrators are not permitted to cover excluded drugs," Shearer said.

Surgener said patients still have options, such as an appeal, when these types of claims are refused, although the process can be long. She said such drugs also might be covered if they are given in a hospital or by a doctor, as opposed to being taken by the patient at home.

However, unless the patient completes paperwork, the doctor can’t file an appeal on the patient’s behalf, Shearer added.

Malkin said Oertel’s case highlights several of the problems with health care in America, including a lack of portability of health insurance and a lack of respect for the treatment decisions made by doctors.

He said there is an utter random nature to the approval process in which people at private insurance companies as well as Medicare and Medicaid can make ill-informed life-or-death decisions.

The dark path

With weakness on her right side from the growing tumor, Oertel moved from her apartment into an assisted living center earlier this month.

How she got to that point is complicated.

The pivotal event appears to be a move from Fond du Lac County to Winnebago County in November 2007.

The change in residence triggered a review of her Social Security disability status, Oertel said. She said Social Security personnel said they sent her a letter, but she never received it.

In any event, she went to a Walgreens in Oshkosh to pick up her interferon and was told that her coverage had been canceled.

Oertel and her sister, Terrie, a registered nurse, said it took five months to reinstate her insurance coverage.

In the meantime, an FDA-approved drug, Temodar , that was not available when Oertel was diagnosed in 1998, now was available, Malkin said

Because the drug was proven and interferon was not, Malkin said he felt ethically compelled to use the approved drug.

He said he always felt he had interferon to fall back on in case Temodar failed.

"I never dreamed that access to interferon would ever be an issue in Paula’s case, or in anybody else’s for that matter," he said.

He said he has two other glioblastoma patients on interferon. Both are stable and, without an appeal, their private insurance companies are paying for the drug, minus a $20 monthly co-pay.

Temodar seemed to work for a while. Oertel started taking it in March 2008 and by January 2009 she was in remission with no sign of the tumor, he said. She went off Temodar, as is recommended after a 12-month standard course. However, in June 2009 the tumor returned and the drug was started again.

This time there was no response, so she went back to Froedtert for a third brain surgery. She also was started on Avastin, another newer drug that was approved to treat her condition.

Both drugs are expensive -- Temodar, about $2,500 a month, and Avastin, about $20,000 a month, Malkin said. But because they were approved, Medicare covered the cost.

Malkin said the Avastin produced a partial response. But by February of this year the tumor was back.

"Now we have run out of FDA-approved agents," said Malkin.

Malkin is a consultant for Genentech, which makes Avastin, and until recently had been a speaker for Genentech and Schering-Plough, which makes Temodar. He said his financial relationship with those companies played no role in his treatment decisions with Oertel.

When he tried to put Oertel back on interferon, it was rejected, he said.

Malkin said he believes it is the only drug that has a chance.

But Medicare won’t pay for it.

"We don’t get explanations," he said. "We just get ‘yes’ or ‘no.’ "

Glimmer of hope

He noted her impressive response and nine-year remission with interferon.

In addition, there is some research suggesting that interferon might be effective in some brain tumor patients. Unlike chemotherapy, he said, the drug seems to work primarily by boosting the immune system’s own ability to fight the tumor.

A 2006 study involving 109 glioblastoma patients found that interferon plus conventional radiation showed a trend toward improved survival.

Indeed, there may be a small minority of patients who benefit from the drug, said Howard Colman, lead author of the study in the International Journal of Radiation Oncology Biology Physics.

"You just don’t know how to pick out those patients ahead of time," said Colman, an assistant professor of neuro-oncology at the University of Texas MD Anderson Cancer Center in Houston.

Colman said there need to be more lenient rules for patients such as Oertel.

"It is very unfortunate, especially for a patient who is benefiting from a drug," he said. "The system has to figure out what is reasonable."

With tears running down her face, Oertel said she thinks her tumor would shrink if she could get back on interferon.

Malkin said he thinks there is a chance it will work."It might not," he said. "But the fact that it worked before is the most powerful lesson that it might work again. This isn’t a crap shoot. She at least has a track record with the drug.

"But I’m worried that this thing is starting to grow back while we are being forced to spin our wheels."

John Fauber reported this story in a joint project of the Journal Sentinel and MedPage Today. MedPage Today provides a clinical perspective for physicians on breaking medical news at www.medpagetoday.com.

To see more of the Milwaukee Journal Sentinel, or to subscribe to the newspaper, go to http://www.jsonline.com.

Copyright (c) 2010, Milwaukee Journal Sentinel

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Posted: March 2010


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