I-Team: Dear insurance company, please save my life

Cancer patients question decision-making

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Copyright 2011 Scripps Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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Posted: 07/27/2011

CINCINNATI - When Greg Lester’s doctor told him he had prostate cancer, the Northern Kentucky resident didn’t shed a tear. Instead he and his daughter, Jennifer Haas, got busy researching the disease and the latest treatments available.

Their research led to a technology no local doctor offers but that is available in Columbus, Ohio and Lexington, Kentucky. It’s called CyberKnife.

Don’t let the name fool you. CyberKnife doesn’t cut. Instead of surgery, this is robot-driven, high-dose radiation. A machine adapted from car assembly lines moves around the patient, and radar-like pinpoint beams target the tumor only. Instead of the risks associated with surgery and the time it takes to recover from an operation, some patients report going from treatment directly to work. Doctors say the number of treatments is much shorter too. Rather than 40 or more sessions with standard radiation that would span more than two months, CyberKnife takes five treatments in one week.

But the part that sold Lester lay in the results. Because the radiation is so precise, it spares normal surrounding tissue. Studies Lester and his daughter found and the I-Team reviewed show the same or better outcomes as older radiation treatments, with cancer abated in more than 90 percent of cases and with lesser incidence of complications including loss of bladder control, erectile dysfunction and the need for colostomy bags.

Dr. Doug Widman, the medical director of Columbus CyberKnife said, “The results really have been terrific… Our patients have very little in the way of any side effects. It’s really much different than conventional radiation therapy because it’s so localized.”

CyberKnife got Food and Drug Administration approval 10 years ago for use anywhere in the body, including the prostate. Since then, more than 500 articles have been printed about the technology, many about its use for prostate cancer patients, including a favorable outcomes study that followed such patients for five years. It found 'fewer side effects,' 'notably shorter' treatment, 'more immediate return to normal daily routines' and 'potentially reduced health care costs' because treatment has dropped from $150,000 three years ago to $35,000 today.

Still, insurance companies including Humana and Anthem call the technology experimental. Humana’s public information officer, Jeff Blunt, says there’s a lack of scientific studies in the medical literature Humana considers.

“Humana follows Tier 1 medical journals only – those most respected and recognized as the current, accepted medical opinion," Blunt said.

Likewise, Anthem’s Kim Ashley said, “It is unfortunate for our members and anyone dealing with this disease that no high grade randomized clinical trials comparing Cyberknife to… other types of radiation have been published; this means it has not been established whether or not this form of radiation therapy has the same, better or worse clinical outcomes when used in treating such individuals.”

Despite this policy, both insurers or their affiliated insurance companies have made exceptions for some prostate cancer patients. Lester’s doctor, oncologist and clinic all recommended CyberKnife as his best option. Anthem denied his request. Yet, Anthem's parent company has covered the procedure on some of its plans, calling it "medically necessary" and "effective" for prostate cancer.

Given that Anthem has covered the treatment for patients with Medicare, Lester says his doctor advised the then 64-year-old, “‘Why don’t you wait eight months and the bill will be paid for?’ And I said, 'Well, if something was attacking you, would you wait eight months?’”

The I-Team read through hundreds of pages of documentation including a letter Anthem sent the very hospital where Lester sought treatment in 2008. On May 20 of that year, Anthem sent the hospital in Lexington a letter regarding another patient, saying “CyberKnife is appropriate for the treatment of prostate cancer and is supported in peer reviewed journals.” The letter went on to say, “This therapy fits the definition of good medical practice.”

Just five months later that year, Lester requested the same treatment. Anthem denied him, calling the procedure “experimental/investigative” and saying, “There is not sufficient scientific data to support” CyberKnife to treat prostate cancer.

We asked Anthem how it squared these two opposing viewpoints, but Ashley’s written response to us did not answer that question. It said, “Our members have the option of an appeals process, which provides them access to independent and external reviews.”

Lester and his daughter initially lost at every stage of that process.

“It’s frustrating. It’s frustrating when you know it’s a recognized, acceptable treatment and they keep telling you that it’s not,” Haas said.

Haas continued to appeal directly to Anthem even beyond the final official review, and finally got a reversal, a letter from Anthem saying it would make an exception in Lester’s case, but not

a change in its policy toward CyberKnife in general. Haas says patients shouldn’t have to go through years of appeals and detective-like proof-gathering to win their cases.

“I just think that ultimately they need to change their policy so other people won’t have to go through it,” Haas said.

For now, other patients seeking the same treatment for the same disease still face denials. We spoke to a Humana customer diagnosed with prostate cancer in 2010. He waited nine months through repeated denials in the appeals process before paying for the treatment out of pocket in May. That’s what Lester did too, working out a payment plan with the hospital. Anthem now has paid him and the hospital back. The Humana patient and his daughter, Sarah Ward, vow to continue their fight as well.

“Any guy in his right mind would want this choice,” Ward said.

She calls the outcomes a no-brainer and says her 57-year-old father was able to go directly from each of his five treatments in Columbus to work here in Cincinnati. She says her family is thrilled with the results, avoiding those complications they dreaded when they heard the diagnosis. She says after ten years and so many studies, the insurance companies should allow this treatment if a patient and his doctors determine it to be the best choice.

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More of Anthem Blue Cross and Blue Shield in Ohio Public Relations Director Kim Ashley’s statement:

Anthem takes very seriously the health and well being of our members and those with serious diseases. Our medical policy positions are evidence-based and not about cost.

We carefully review the clinical literature regarding treatment options and the evidence regarding these specific treatments. One organization’s guidelines we consider carefully is the Federal Government “Agency for Healthcare Research and Quality.” Unfortunately, as recently cited in that agency’s Effective Healthcare Program Review on “Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer,” emerging technologies have not been evaluated in randomized trials. Cyberknife is one of those emerging technologies. It is unfortunate for our members and anyone dealing with this disease that no high grade randomized clinical trials comparing cyberknife to IMRT and other types of radiation have been published; this means it has not been established whether or not this form of radiation therapy has the same, better or worse clinical outcomes when used in treating such individuals. Prostate cancer is not a rare disease and we are hopeful additional significant clinical trials will be published soon and guidelines can be established accordingly.

Of course we cannot comment on how other carriers make their medical policy decisions, but again, ours are evidence-based and not related to cost. It’s also important to note our members have the option of an appeals process, which provides them access to independent and external reviews at certain stages in the review process.

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Humana Regional Strategic Communications Manager Jeff Blunt’s answers to some of our questions:

(WCPO) We have several cases in which Humana has approved CyberKnife treatment for some prostate cancer patients. Why some but not others?
(Jeff Blunt)Our coverage policy states that SRS (a.k.a. CyberKnife) is not covered for prostate cancer. We’re not aware of any cases in which SRS has been authorized for prostate cancer treatment. However it is possible that it could be covered if an employer who has a self-pay plan (i.e. they pay their own claims and pay Humana to administer the plan only) could choose to go against the medical literature and simply pay for SRS treatment for prostate cancer. This would be highly unusual, though.

(WCPO)If CyberKnife is “experimental” for prostate cancer, then why do you ever allow it for any patients?
(JB)Our policy is that we do not cover SRS treatment for prostate cancer - so except in a very rare case, such as listed above, it would not be.

(WCPO)Your statement speaks of a lack of published, reviewed clinical outcome studies, but we’ve found hundreds of articles including peer-reviewed scientific articles and at least one 5-year outcome study that conclude CyberKnife does at least as well if not better than older radiation and surgery alternatives when it comes to prostate cancer outcomes while offering significantly fewer treatments over a shorter time period with no hospitalization and its associated risks and recovery time. In addition, the F.D.A approved CyberKnife for the entire body ten years ago after looking at extensive data. Can you explain why this body of literature isn’t sufficient for Humana? How can you continue to cite a lack of studies despite the volume out there?
(JB)Citing outcome studies is a bit like quoting information found on the internet; it’s possible to find a source to support just about any position. Humana follows Tier 1 medical journals only (American College

of Radiology, American Heart Association, etc) - those most respected and recognized as the current, accepted medical opinion. For a list of the Tier 1 literature and the specific articles we used for this coverage determination, please see page 8 of our policy (attached). Regarding the FDA, it’s important to note that FDA approval means only that a device or procedure does what is supposed to do (in this case, obliterate tissue). It does not make judgments or evaluations as to clinical effectiveness or outcomes vs. other treatment options. So, FDA approval does not speak to whether or not CyberKnife is advantageous as compared to the current standard of care.

(WCPO) CyberKnife costs have decreased so this therapy is no more expensive and in some cases less expensive than older radiation and surgical options you approve. Why do you not allow patients this cheaper choice if they and their doctors recommend and choose this as the best option?
(JB)This is because cost is not a part of the determination of coverage. Our policy determinations are based on medical evidence for improved outcomes only, and the currently accepted standard of care for prostate cancer does not include SRS.

Copyright 2011 Scripps Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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