Hutchinson Clinic audit: Cancer doctor ‘unnecessarily’ treated patients

Audit at Hutchinson Clinic: Cancer doctor ‘unnecessarily’ and ‘inappropriately’ treated patients

08/23/2014 4:00 PM

08/23/2014 11:29 PM

“Is it cancer?”

It took days for anyone to answer Marian Rank’s question, but by then she knew.

Her mother had breast cancer. Her sister had it.

Now she did.

It was 2010, and Rank went to the Hutchinson Clinic to see oncologist Mark Fesen.

Fesen told her she needed to start chemotherapy immediately, said Rank, who was 66.

“Chemo is as scary as cancer,” Rank said. “It kills so much of you in order to kill the cancer.”

She had to make a decision about trusting her doctor – a decision nearly all of us have to make at some point.

As she learned more, Rank began to question her doctor’s orders.

She sought a second opinion, then a third and ultimately was advised that she didn’t need chemotherapy.

That same year, the Hutchinson Clinic began questioning Fesen’s practice.

Internal audits, requested by the clinic, stated that Fesen treated some patients for cancer who didn’t have it and “unnecessarily” and “inappropriately” treated others.

The auditor questioned Fesen’s competency in treating some cancers.

The audit and other documents also said that Fesen:

– Did not follow established national cancer-treatment guidelines in about 40 percent of the patient cases reviewed.

– Treated some patients with lymphoma and cancers of the blood “unnecessarily” and “often too early, too much and too long.” The auditor suggested that Fesen should either not be allowed to treat those patients or be required to get board certification in that area.

– Frequently split doses of chemotherapy and other drugs, without documenting why.

– Overprescribed support IV therapies, such as minerals and antibiotics, and gave patients with blood cancer an excess number of bone marrow tests. The auditor questioned whether an external insurance audit would find documentation to justify the treatments. The clinic worried that some of Fesen’s actions might be “interpretable” as Medicare fraud.

It is unclear whether the clinic told patients about the review or its findings.

Fesen practiced at the Hutchinson Clinic from 1993 to 2011, leaving the clinic five months after the second audit.

Now he practices in Wichita.

Both the Hutchinson Clinic and Fesen refused interview requests, saying that they are unable to comment due to legal concerns. Fesen e-mailed a statement through his spokesman, Eddie Reeves: “As frustrating as it is for me, I am prevented by law from responding directly to the troubling line of questions you have asked. For instance, you reference having documents that purport to go to the heart of things like medical peer review and regulatory processes. I cannot by law even confirm or deny that such events even occurred. So even if what you have been evidently been given improperly were totally false or misleading, or made up out of whole cloth, I could not legally offer you evidence of that because doing so would go to the heart of protecting patients’ confidential medical information.

“Here is what I can say: My whole professional life has been dedicated to providing the utmost in quality, compassionate, consistent care to my patients, and I categorically and vehemently deny ever doing anything other than that. If someone works harder or longer to care for cancer patients, or to stay abreast of the latest and best medical advances to do so, or to consult with experts nationwide when necessary, I don’t know who that is.

“Part of providing that level of care is abiding by the laws that keep medical information private, and I will honor the law even if others for their own businesses or personal reasons might decide not to do so.

“The bottom line is that I am passionate that my patients – no matter what their demographic, geographic or economic situation – have access to the best care I can provide. That is not just what I do, that is who I am.”

‘He’s a great doctor’

Fesen has no record of medical malpractice lawsuits or disciplinary action by the Kansas State Board of Healing Arts.

Originally from New Jersey, Fesen graduated from the Robert Wood Johnson School of Medicine at Rutgers University in 1987. After completing his residency and a fellowship with the National Cancer Institute, he started his practice at the Hutchinson Clinic in 1993, according to biographical information in his book “Surviving the Cancer System.”

Fesen has hospital affiliations with Via Christi Hospitals Wichita, Comanche County Hospital in Coldwater, Mitchell County Hospital in Beloit, Scott County Hospital in Scott City and St. Catherine Hospital in Garden City, according to Medicare’s website.

Fesen also was appointed to a congressional advisory committee on health care earlier this year by Rep. Pete Sessions, R-Texas.

Since he left the Hutchinson Clinic in 2011, Fesen has practiced at Central Care Cancer Center, which is physician-owned, with offices in Wichita. He also sees patients in Great Bend and Dodge City, according to the clinic’s website.

“There’s really nothing that has impacted us in the least. He’s practicing perfectly well,” said Claudia Perez-Tamayo, president of Central Care Cancer Center. She said he sees patients insured through Medicare and Blue Cross Blue Shield.

“We have zero knowledge or understanding of what Hutchinson Clinic is going through. I don’t know what to tell you. He’s a great doctor.”

Jo Murphy, a nurse who now lives in Sylvan Grove, was a patient of Fesen’s.

“I was treated with efficiency and kindness by Dr. Fesen and his staff from the very first day on through the long months of my treatment and afterwards as well,” Murphy wrote in an e-mail.

About a year after her treatment, Murphy joined the oncology staff at the Hutchinson Clinic to work with Fesen.

“His decisions and practices demonstrated to me that he always had the best interests of his patients and his staff in mind,” she wrote. “We respected and trusted him and he respected and trusted us. One of the nurses that I worked with described our working relationship in this way: ‘Dr. Fesen always had our backs and we had his.’ ”

‘God-like’ status

In 2010, physician Roger Gingrich, professor emeritus of internal medicine at the University of Iowa Carver College of Medicine-Hematology, Oncology and Blood and Marrow Transplantation, was brought in by the Hutchinson Clinic to internally review Fesen’s practices.

The Wichita Eagle obtained copies of two audits, which contained aggregate data about the practice, communications between the auditor and clinic executives and several case reviews that looked more in-depth at patient diagnoses. Patients’ names were redacted.

Gingrich, the auditor, has since retired and would not discuss the audits.

The audits, conducted in 2010 and 2011, stated there were major compliance issues with the National Comprehensive Cancer Network guidelines, which are based on research from the top 25 cancer centers in the country and are generally accepted as the basis for the treatments physicians prescribe.

The auditor reviewed 108 of Fesen’s cases that were randomly selected, according to an internal document. In about 40 percent, the auditor cited issues with inappropriate diagnosis or treatment.

For example, one patient was treated for more than four years as having lymphoma, a cancer of the lymphatic system. The patient didn’t have cancer, according to the auditor.

Another 86-year-old patient had MGUS. Monoclonal gammopathy of undetermined significance is a noncancerous condition that usually causes no problems and generally requires no treatment, according to the Mayo Clinic. The patient was “inappropriately” treated for nearly three years with the chemotherapy drug cyclophosphamide, according to a case review.

In another case review, the radiological diagnosis of active lymphoma in an 83-year-old “is a fantasy,” Gingrich wrote. That patient was given Rituxan, an antibody drug used with chemotherapy, almost continuously for eight years. Because it can damage the immune system, the manufacturer says that the drug should not be used for more than two years.

“There is no body of medical evidence that would justify using Rituxan in this patient as Dr. Fesen has used it since 2002,” Gingrich wrote. The patient “not surprisingly” developed an immune deficiency disease, he wrote.

Some patients’ records were too poorly documented to tell whether they were compliant, according to the audits.

Gingrich also questioned whether Fesen was competent to treat patients with lymphoma and blood cancers. “A significant fraction of them are being unnecessarily treated – often too early, too much and too long,” he wrote.

Gingrich also reviewed records of the clinic’s other oncologist, Fadi Estephan, and identified no compliance issues.

The clinic, which is owned by about 70 physicians, would not say whether it contacted individual patients about the auditor’s findings.

The clinic responded with an e-mailed statement through its attorneys: “Hutchinson Clinic is committed to providing high quality patient care to the patients we serve. As part of this effort, we periodically conduct peer review regarding the clinical practices of our physicians. The law requires that peer review investigations be kept confidential and we therefore cannot comment on the findings or outcome of any investigation, or even that a peer review investigation was done in regards to any specific physician. To our knowledge, Dr. Fesen’s Kansas license remains active with the Kansas Board of Healing Arts and he is continuing to practice. Peer review laws, patient confidentiality and our corporate policy prevent us from making further comment at this time.”

If a health care organization finds that a certain level of harm may have occurred, it has an ethical obligation to disclose its findings to patients, said Christine Mitchell, executive director of Harvard Medical School’s Center of Bioethics, speaking generally. She has no specific knowledge of the Hutchinson Clinic audits.

“I think there’s a general duty to be open,” Mitchell said.

“There is an obligation to inform patients when they’ve got enough clarity from an internal investigation to know that there was a very strong likelihood of harm to patients – alerting them that an audit was done, in general what the findings were and making sure they connect with their current physicians and look at records, treatments and do a thorough assessment of how they’re doing now. That would be a starting place.

“It’s harder to contact patients if they have a concern about opening themselves up to potential liability,” Mitchell said.

In a 2010 internal document, Gingrich wrote to the clinic’s chief financial officer, Michael Harms, summarizing his visit to the clinic and interviews with staff members.

“Fesen’s decade-long solo practice created a ‘god-like’ status where mid-level providers and nurses did not question his practice style and this atmosphere still creates difficulty,” Gingrich wrote. “Dr. Fesen’s practice includes the off-label use of oncology drugs and non-evidence based dosing and schedule variation.”

The document went on to state that the clinic had raised concerns that some of Fesen’s actions “might conceivably be interpretable as fraud” by Medicare.

In October 2011 – about five months after the second audit was completed – Fesen announced that he was leaving the Hutchinson Clinic at the end of that year for Central Care Cancer Center in Wichita.

According to public records from Fesen’s divorce, his gross annual income as of May 2011 was about $1.2 million, and it dropped to about $800,000 in June 2012.

Cancer ‘merry-go-round’

Marian Rank, the breast cancer patient, is a retired English teacher who lives in a farm house outside of Abbyville (population 89), about 21 miles southwest of Hutchinson.

“I went to Dr. Fesen because everybody else went to him,” she said.

In 2010, Rank had a lumpectomy to remove the tumor with another physician at Hutchinson Clinic and discussed the next step – and Fesen’s recommendation of chemotherapy – with her son in Kansas City and daughter in Denver.

“They both said, ‘You’re not doing anything without a second opinion.’ ”

So she went to the Rocky Mountain Cancer Center in Denver and met with oncologist Dev Paul, who did not respond to The Eagle’s interview requests. She also met with Shaker Dakhil, an oncologist and president of the Cancer Center of Kansas in Wichita, a competitor of the cancer center where Fesen now practices.

According to medical records that Rank shared with The Eagle, both Paul and Dakhil told Rank the best practice for cancer patients such as her who meet certain criteria is a genetic test called the Oncotype DX, a test that has been around for about 10 years that can help determine whether chemotherapy is necessary.

The test analyzes 21 genes and predicts the chances of cancer spreading to other organs.

Scores less than 18 have a low risk of the cancer spreading or coming back.

Scores from 18 to 31 have an intermediate risk, where it’s unclear whether chemotherapy would help.

And those who have scores greater than 31 have a high risk of the cancer coming back and a greater benefit from chemotherapy.

Rank said she was told by Fesen that she couldn’t have the test and that Medicare wouldn’t cover it. She said he tried to dissuade her from having the test and told her that even if she paid for it herself, the subsequent treatment would also not be covered by Medicare.

The results of Rank’s test – recommended by Paul and Dakhil and paid for by Medicare – were a 13, which showed the chance of her cancer returning was 9 percent.

The low score meant that with or without chemo, the chance of cancer returning wouldn’t change, making the chemo unnecessary, Dakhil said.

“It’s a merry-go-round. You don’t know where you’re going next,” Rank said.

“Before the test (was created), a lot of people got chemo, and we found out that half did not need it,” Dakhil said. “If you accept the science and believe that only people who need chemo should be offered chemo, then you should offer the test to the patient.”

Chemotherapy has a lot of side effects, according to the National Cancer Institute.

Those side effects include fatigue, nausea, vomiting, hair loss, infection, memory impairment, swelling and pain – not to mention the psychological impact.

Instead of chemotherapy, Rank had radiation treatment for her cancer (“It was a snap”) and was prescribed an anti-hormone pill by Dakhil to take for the next five years.

Radiation treatment is a concentrated dose that attacks a tumor, whereas chemotherapy moves throughout the body.

“The idea that a doctor would prescribe chemo to somebody who didn’t need it – who it would only harm – is so unconscionable that I couldn’t imagine it was really happening,” Rank said.

In January 2011, Rank filed a complaint against Fesen with the Kansas State Board of Healing Arts.

Dose splitting cited in audit

Dose splitting – also called dose-fractionation – was a frequently cited issue in the 2010 audit.

Fractionation is where a physician splits the dosage of chemotherapy or related drugs and administers them over a period of days or weeks. In Fesen’s case, he was often splitting doses and administering them seven days apart, according to the audit.

With every office visit, lab and dose, physicians can bill Medicare, the government program that pays the majority of health care costs for most people over 65.

Dose splitting is acceptable if, for example, the patient can’t tolerate a full dose, Dakhil said.

But that would need to be documented in the patient’s record, he said.

“The high frequency for choosing the day 1-8 fractionation scheme suggests a rationale in Dr. Fesen’s mind other (than) patient-specific factors such as a suspected intolerance to the recommended and conventional way of dosing these medications. The rationale Dr. Fesen has in mind is never identified in the medical record of these patients,” the audit said.

Cancer drugs and related therapies are expensive.

The Medicare reimbursement for the drug Rituximab, or Rituxan, is about $693 per 100 milligrams.

Each typical dose of the drug is 800 milligrams, which for some cancers is given 12 times over two years, Dakhil said, totaling about $66,500. Typically, about 95 to 97 percent of that covers the cost to the physician for buying the drug, he said.

When the dosages are split, physicians can bill Medicare for additional treatments. Payments made by Medicare are per service, and chemotherapy administration is paid by the hour, Dakhil said.

“So if you give a patient a treatment on Day One and Day Eight, your administration reimbursement would be twice as much than if you gave the whole thing on Day One,” Dakhil said.

“The problem is if you have to dilute the treatment to a point that it becomes ineffective. That becomes an issue. If you have to fractionate a treatment because of tolerance of a patient, that’s justifiable.”

The Hutchinson Clinic audit noted that medical documentation by Fesen was poor in general.

By the time the auditor did another round of reviews in April 2011, “the previously seen rampant dose-fractionation” had “essentially disappeared” for patients who had solid tumors. That audit checked 49 of Fesen’s patients’ records, or 10 percent of new patients.

The auditor also found that Fesen’s compliance in following national guidelines had “greatly improved.”

However, the audit said there was clear continuance of excessive use of IV therapies and excessive bone marrow tests without documentation of necessity.

Both audits mentioned the extended use of the drug Rituxan, in some cases for as long as six to eight years.

The drugmaker’s website, the National Comprehensive Cancer Network and studies from the National Cancer Institute support the use of Rituxan for up to two years but not more, because it can cause kidney, heart, stomach and bowel problems and serious infections that can lead to death.

Dakhil, who said he has seen several of Fesen’s former patients, said he has also observed extended use of Rituxan.

“I have seen patients who have requested a second opinion or transferred care to my practice, and my impression was very similar (to the auditor’s),” Dakhil said.

“I have seen patients who have received Rituxan for many years and there was no clear documentation why they were getting it or what was the indication of getting it.”

Declining Medicare claims

Medicare data obtained by The Eagle through the Freedom of Information Act show that Fesen’s claims dropped by about one-fourth from 2009 to 2011 to about 68,000 by the time he left the Hutchinson Clinic.

The data showed that in 2009, Fesen’s practice was reimbursed slightly more than $9.5 million by Medicare. That number declined to about $7.9 million in 2010, the year internal audits began at the clinic. In 2011, he was reimbursed just over $7 million by Medicare.

At the time the audits began, the Hutchinson Clinic spent about $30 million annually on cancer drugs and had about 750 new cancer patients each year, according to internal documents.

‘Treat, treat and treat some more’

In 2009, Fesen wrote a book called “Surviving the Cancer System,” in which he describes his philosophy: “Treatment recommendations are educated guesses. Guidelines are not perfect. Many new developments have come about because some brave proactive oncologist has not limited his treatments to only approved guidelines and has tried something, anything, in a desperate situation.”

In the 2011 audit, Gingrich questioned Fesen’s judgment on when to quit treatment with patients and to bring in end-of-life care.

He mentioned a patient with metastatic ovarian cancer that was to be treated with her ninth different chemotherapy regimen after eight others had failed.

“Reasonable oncology judgment would dictate a strong consideration if not a mandatory switch to best supportive care with a palliative care – hospice team on board. This option is apparently not considered by Dr. Fesen in his dictated clinical note,” Gingrich wrote in the audit. “Dr. Fesen’s default is to treat, treat and treat some more with no apparent consideration for involving a palliative care team.”

In the same audit, he wrote, “A clear and honest appraisal of the goals of therapy might suggest that consideration for stopping therapy/referral to palliative care – hospice should come earlier in many of Dr. Fesen’s patients.”

‘Blind trust’

Every few months after filing her complaint, Marian Rank – who is now 70 – received a letter from the Kansas State Board of Healing Arts, saying the investigation of Mark Fesen was in progress.

She called several times to ask what was taking so long since she first complained more than three years ago.

“I think if it is lack of help – lack of people who can do it – they need to hire more people, because this is serious,” Rank said. “No investigation should take this long.”

Earlier this month, she received a letter from the board saying the investigation had been completed and the results would be reviewed. The letter did not say whether there were any findings.

Officials from the Board of Healing Arts said they cannot confirm whether doctors are under investigation and cannot comment on specific cases.

The board, formed in 1957, serves as the licensing and regulatory agency for medical doctors and some other health care providers in the state. It has 15 members, who are mostly health care professionals, and they are appointed by the governor.

From January 2009 to January 2014, the board received more than 11,000 complaints, according to a response to an open-records request by The Eagle, and as of Jan. 1, the agency had 542 open investigations.

In 2013, the board took about 240 actions against providers.

Patients should question their doctors, Dakhil said.

“Cancer patients have complete trust in their cancer physician,” Dakhil said. “And that trust has to be earned, not imposed.

“Unfortunately, right now the way things work is patients have a blind trust of their cancer physician. They don’t check things out. They don’t ask questions. They don’t ask the communities about the credentialing of that person. And there is no way you can justify that trust.”

Everyone should get a second opinion, Rank said. But that can be difficult.

“We trust our doctors. It’s hard to question as a patient,” Rank said. “For my generation, it’s hard to question a doctor, because they’re supposed to know what they’re doing. ... I would have just gone along like everybody else.

“It’s hard to get a second opinion and say to your doctor basically ‘I don’t believe you.’ ”

Reach Kelsey Ryan at 316-269-6752 or kryan@wichitaeagle.com. Follow her on Twitter: @kelsey_ryan.

Resources

To view the National Comprehensive Cancer Network guidelines for cancer treatment, visit www.nccn.org/patients/guidelines/default.aspx.

To lodge a complaint with the Kansas State Board of Healing Arts, e-mail complaints@ksbha.ks.gov or call 785-296-1788. There is also an online complaint form that can be printed and mailed that is available at www.ksbha.org/forms/complaint.pdf. The mailing address is 800 SW Jackson, Lower Level-Suite A, Topeka, KS 66612.

To see whether a physician has been subject to disciplinary action by the Board of Healing Arts, visit www.ksbha.org/boardactions/boardactions.shtml.

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