Digital Pathology Blog

Mayo model praised, but can it last?

By Jeff Kiger Post-Bulletin, Rochester MN 

Recent weeks have cemented the Mayo Clinic's reputation as a health care superstar but raised the ominous question of how long that can continue under the present U.S. health care system.

	Time Magazine excerpt: "The Mayo clinic attracts Kings and Presidents, injured athletes and ailing billionaires. ... But Rochester's costs are well below the national average because Mayo also provides tremendous value for ordinary care ..."

With the health reform debate heating up, Mayo Clinic has been praised on the national stage as a model for offering quality health care at a low price. Those patting Mayo on the back include President Obama, Time magazine and The New Yorker magazine.

But the question has been raised: Can even Mayo continue to use the Mayo model?

Dr. Atul Gawande's article in The New Yorker magazine June 1 showed that Mayo's per-person Medicare costs in Rochester were low even though it provided a high level of care. He contrasted that with McAllen, Texas, which has some of the high costs but poor quality.

The system of paying for medicine doesn't reward Mayo's quality, and instead drives up costs by encouraging doctors to order pricey scans and surgeries, as they do in McAllen, Gawande concluded,

In his article, "The Cost Conundrum," Gawande wrote, "In the war over the culture of medicine the war over whether our country's anchor model will be Mayo or McAllen the Mayo model is losing."

That was echoed in a June 29 Time magazine article on the Mayo model, which details Mayo's "institutional obsession with evidence-based medicine" it keeps track of what works and does it. Also, Mayo pays doctors fixed salaries so they don't make more if they do more to patients and they don't make less if they take more time to talk to them, the article said.

Mayo Dr. Dawn Milliner was quoted as saying, "We've been able to buffer our staff from the harsh realities of the system, so they can concentrate on patient needs, But it's not clear how long we can keep doing that."

Gawande explained his conclusion this week.

"Their (Mayo's) practice model is closer to the quality and cost we want, though we have a financing system that doesn't make it sustainable," wrote Gawande in an e-mail. "My conclusion is that it's the financing system that has to change, not the medical system."

Mayo Clinic, which lost $840 million on $1.7 billion in Medicare treatment last year, agrees.

"That's the underlying reason we are involved in health care reform," says Josh Derr of the Mayo Clinic Health Policy Center. "The Medicare system is a fee for care system. We want to that shifted to value."

Derr says the short-term fix would factor value into Medicare reimbursement. The longterm fix tosses out the pay-per-service plan, to be replaced with something like a bundled care method. That means a heart attack would be covered with one fee for all related treatment and that encourages a hospital "to do things right the first time," he said.

Of course, change may take a long time, even if Obama admires Mayo's methods.

"Mayo will still find way to stick with its model of care going forward," Derr says. "We'll just have to find different ways to do that."

Dr. In S. Pole Rescue Loses Cancer Battle

Dr. Jerri Nielsen FitzGerald was the center of a dramatic 1999 rescue.

(CBS/AP)  Dr. Jerri Nielsen FitzGerald, whose struggle against breast cancer during a winter at the South Pole captivated the world, has died. She was 57.

Her husband, Thomas FitzGerald, says she died Tuesday at their home in Southwick, Mass. The cause was cancer.

Nielsen was the only doctor at the Amundsen-Scott South Pole Station when she found a lump in her breast in June 1999, raising fears of cancer. Weather conditions didn't permit a rescue, so she performed a biopsy on herself with the help of staff.

She began treating herself using drugs dropped by parachute in the dark polar winter in July, in a mission documented by CBS News.

Despite her illness Nielsen kept busy with her duties up until she left the South Pole, her sister-in-law, Diana Cahill, told CBS News in 1999.

"She didn't have time to focus on her condition at all. She's a very giving person," Cahill said.

Following the dramatic airlift, she told The Vindictor newspaper she wanted to return to the Antarctic.

"It was such a wonderful place. I still love it. I would do it again. Even knowing what happened to me, it was the best year of my life," Nielsen told the newspaper.

Her cancer went into remission until 2005.

Mayo Clinic going to Mall of America

My institution recently announced that it plans an outpost amid the roller coasters, restaurants and retailers as the Mall of America expands into a second phase.  At first glance I thought this would be a "retail clinic" within the large shopping center outside of Minneapolis but organizers have some different ideas that may be more beneficial overall to patients and providers.

I recently had an experience at a retail clinic I will write about in the future but think the exposure is positive for the clinic as another entry point for care that may could provide cost-effective health care, counseling, education or accomodate necessary referrals. 

Come to Minnesota for tax-free clothes and stay for your health care needs.  Will see what this will look likes as plans solidify and how health care providers closer to Minneapolis will respond.

Mayo officials said they haven't decided what services the site will offer, but said they could include diagnostic screenings, wellness counseling and other services that might direct patients to the home campus in Rochester.

"The Mall of America provides a tremendous opportunity to provide a gateway to services we provide and a platform for innovation," said Dr. Glenn Forbes, CEO of Mayo Clinic Rochester, adding: "It's not our intention to replicate what we're doing in Rochester."

The new facility might, for example, offer telemedicine consultations and organize logistics for international patients. But it will not offer routine primary care such as treating sore throats and broken bones.

At a news conference last Wednesday attended by Mall officials and Gov. Tim Pawlenty, Mayo executives said they plan to spend the next 12 months deciding the nature of the facility and the size of their investment. There is no opening date as yet.

Twin Cities hospital and clinic chains such as Allina, Fairview and Park Nicollet compete vigorously for patients in specialty care. Should they be worried?

"I would say a little bit," said Allan Baumgarten, an independent Twin Cities health care analyst. "Although most people have longstanding relationships with their doctors, we are going into a time when people are paying more and more out of their own pocket either because they have lost coverage or have high deductibles.

"This gives someone with a brand name like Mayo an opportunity to say 'Don't think of Mayo being 90 miles away. Think of Mayo as being at the Mall of America.' There's a portal there that could lead to the renowned Mayo Clinic."

High school student diagnosis self with pair of "fresh eyes"

While I do not like the statement "Pathologists also sometimes miss important findings for other diseases, says Dr. Mark Graber, chief of the medical service at the Northport VA Medical Center in New York", its context can be found in an article with an amazing story I came across on Lab Soft News with some valid comments.

In this particular instance, inflammatory bowel disease can be difficult to diagnose and manage as the biology and causes are still poorly understood.  Histologically, the findings may be non-specific and granulomas are actually rarely present on endoscopic biopsies (less than 30% of cases and perhaps much less than that).  And not all granulomas are Crohn's disease.  Nonetheless, Jessica became an active participant in her health care and is clearly a bright student who now has some answers to questions long unanswered.

Perhaps Jessica Terry is a future pathologist with a keen eye for detail that is required.  I think the article also points out opportunities for pathologists to engage high school students and educate them about medicine and pathology.  It also points out the power and effectiveness of direct pathologist-patient communication, as in this case, with the power of second consultation with "fresh eyes". 

Mayo Clinic Finds New Pathology Tests Double Sensitivity to Detect Bile Duct and Pancreatic Cancers

Pancreatic cancer and bile duct cancer are difficult to diagnose and often fatal because they are discovered in the advanced stages of the disease. Researchers have developed new tests that double the ability to detect bile duct and pancreatic cancers, according to a Mayo Clinic study published in the June issue of Gastroenterology.

-- Additional audio and video resources, including excerpts from an interview with Dr. Lewis Roberts describing the research, are available on the Mayo Clinic News Blog, password: fish059.

Pancreatobiliary tumors such as bile duct cancer (cholangiocarcinoma) and pancreatic cancer often present as strictures, or a narrowing of the duct that can either be caused by benign inflammation or cancer. Physicians insert an endoscope down the throat and into the bile duct and pancreas region to examine possible tumors; however, the narrowness of the bile duct makes it difficult to distinguish benign and malignant strictures.

In this study, 498 patients with pancreatobiliary duct narrowing underwent an endoscopic procedure, and cell brushings were taken. Brushings were then analyzed by routine cytology, digital image analysis and fluorescence in situ hybridization (FISH) to determine the various tests' effectiveness and sensitivity in detecting and diagnosing cancer. While traditional cytology analysis relies on identifying abnormally shaped cells, the FISH test detects malignant cells using colored probes visible with a fluorescence microscope. Since cancer cells have an abnormal amount of DNA, by FISH these cells show extra copies of the probes compared to normal cells. The Mayo research team found that the combination of cytology and FISH raised the detection rate of bile duct and pancreatic cancer from 20 percent to 43 percent. "Bile duct and pancreatic cancers are very difficult to diagnose," says Lewis Roberts, M.B.Ch.B., Ph.D., Mayo Clinic gastroenterologist and the study's senior author.

"We were very pleased to see that the combination of FISH and cytology significantly improved our chances of diagnosing patients reliably. The earlier we can diagnose a patient, the better the types of treatment we can offer and the more likely they are to have long-term survival after treatment."

Treatments for bile duct cancer vary with the size of the tumor and how far it has advanced. These tumors usually grow slowly and spread gradually. In many cases, bile duct cancers are diagnosed at later stages. Current treatments include surgery, liver transplantation, chemotherapy, radiation therapy, photodynamic therapyand biliary drainage with plastic or metal stents. If the cancer cannot be completely removed by surgery but has not spread outside the liver, chemotherapy and radiation followed by liver transplantation may be an option. Mayo Clinic is one of the few medical facilities that offers a liver transplant protocol for early-stage bile duct cancer patients.

Bile duct cancer is rare and is most common in people aged 50 to 70. Approximately 5,000 cases of bile duct cancer are diagnosed in the United States each year, and the incidence of bile duct cancer is on the rise. Between 35,000 and 40,000 cases of pancreatic cancer are diagnosed per year in the United States.

Dr. K. Halling and Mayo Clinic have a financial interest in technology used in this research. Dr. Halling and Mayo Clinic have received annual royalties greater than the federal threshold for significant financial interest from the licensing to Abbott Molecular of other technology related to this research.

Mayo Clinic's Division of Gastroenterology and Hepatology has been ranked #1 in the U.S. News & World Report Honor Roll of Top Hospitals since the rankings began 19 years ago.

Other members of the Mayo research team included Emily Barr Fritcher; Benjamin Kipp, Ph.D.; Kevin Halling, M.D., Ph.D.; Trynda Oberg; Sandra Bryant; Robert Tarrell; Gregory Gores, M.D.; Michael Levy, M.D.; Amy Clayton, M.D.; and Thomas Sebo, M.D., Ph.D.

Platform allows patients, physicians to share diagnostic laboratory test results online

Healthcare IT News (5/15, Hardy) reported that, "through a joint effort by Quest Diagnostics and Microsoft HealthVault, patients and physicians can now share diagnostic laboratory test results online." Physicians "who use Care360, a patient-centric portal from...Quest Diagnostics, can transfer test results in a HIPAA-compliant format to a protected account per patient request." Meanwhile, "patients will be able to use this account to view past and present diagnostic laboratory records from their physicians." According to David Cerino, general manager of consumer health, Microsoft Health Solutions Group, "Lab results are one piece of the puzzle necessary to give people a complete picture of their health, which we are now able to deliver securely through the connection between Quest Diagnostics and HealthVault."

CMS rejects Medicare coverage for virtual colonoscopy

In the past I have blogged about virtual colonoscopy and concern over how in the future this may diminish the number of colon biopsies done to be reviewed.  Others have argued this might actually increase the number of colonoscopies performed and subsequent biopsies, citing a number of reasons, including more people getting at least virtual colonoscopy when age appropriate rather than putting off the more invasive procedure or not getting one at all.  Yesterday CMS rejected the latest proposal to pay for this sevice claiming it wasn't ready for "prime time", as the radiology community has felt. 

So, for the time being it looks like this is not an immediate threat to GI pathologists (if you believe as I do), although I can see the arguments for reimbursement and how this technology may cost costs and save lives. Gastroenterologists are safe from the CT scan as well for now.

As the digital pathology community advances the technology, garners FDA clearances for clinical use and promotes reimbursement for these services, I wonder how CMS will address the issue. 

CPT codes are in place for image assisted IHC interpretation, providing a driver to use the technology with appropriate validation perhaps but will scanned archives, image-linked or enhanced reports, image repositories for data mining or content based image retrieval or enterprise wide PACS image uploads be"compensated".  I think there will be some opportunities to have these services paid for to pathologists and laboratories but will require a tremendous amount of validation of the technologies and will not likely occur for many years to come, particularly if virtual colonoscopy is any indicator.

By Eric Barnes AuntMinnie.com staff writer May 12, 2009

The U.S. Centers for Medicare and Medicaid Services (CMS) today rejected a proposal to pay for virtual colonoscopy (also known as CT colonography or CTC) for routine colon cancer screening of Medicare patients in the U.S., saying that VC, while promising for detecting colorectal polyps and cancer, is "not yet ready for widespread screening use."

"The evidence is inadequate to conclude that CT colonography is an appropriate colorectal cancer screening test under §1861(pp)(1) of the Social Security Act. CT colonography for colorectal cancer screening remains noncovered," the May 12 memo states.

The decision comes as a blow to advocates of CTC, who held out hope that the agency would reverse its proposed February 11 decision to deny reimbursement for screening CTC based on the body of evidence presented to it since the analysis of CTC as a screening tool began last year.

Advocates for virtual colonoscopy were quick to criticize the decision.

"The news is obviously disappointing, but not unexpected, given the inseparable politics and purse strings involved," said Dr. Perry Pickhardt, associate professor of radiology at the University of Wisconsin in Madison. "In the end, CTC will ultimately prevail as a highly effective screening test -- it's simply too good to hold down for much longer."

Dr. James Thrall, chair of the American College of Radiology Board of Chancellors, was even more emphatic.

“Make no mistake: If it stands, this CMS decision not to pay for CT colonography will cost lives. More than 140,000 Americans are diagnosed with colorectal cancer each year. Nearly 50,000 of them die due to late detection. How can CMS ignore the fact that people are dying because they do not want to have the tests that are currently covered?” Thrall said in a statement to the American College of Radiology.

“For CMS to turn its back to a technology that can attract more patients to be screened and save countless lives is deeply concerning," he continued. "CMS should reverse this determination immediately, or Congress should step in and vote to mandate coverage of CTC."

"The decision is understandable in these tough economic times," said Dr. Judy Yee, professor and vice chair of radiology and biomedical imaging at the University of California, San Francisco. "The decision is unacceptable when considering the large body of scientific evidence clearly documenting that CTC has been proven to be as effective as colonoscopy for the detection of clinically significant polyps in adults."

While CMS states that the evidence is insufficient to conclude that CTC improves health outcomes, "the same can be stated for other colorectal cancer screening tests that are currently covered by CMS," Yee told AuntMinnie.com in an e-mail. "We know that colorectal cancer is preventable. We know that a very large percentage of the American public remains unscreened for colorectal cancer. A positive decision from CMS could have helped to change this."

Dr. Abraham Dachman, professor and chair of radiology at the University of Chicago, told AuntMinnie.com that VC utilization is inseparable from efforts to cut healthcare costs.

"CTC experts strongly believe that current data support use of screening CTC in the Medicare aged population as do a large bipartisan group of members of Congress who signed a letter urging CMS to approve coverage of CTC for screening," Dachman wrote in an e-mail. "Even as the nation discusses ways to reign in the cost of healthcare, CTC screening makes sense. Use of CTC for colorectal cancer screening is consistent with President Obama's push for prevention and use of new technology to benefit patients. The public and the medical community at large should work to get this decision reversed."

Radiologists should work to publish data focused on individuals ages 65 and older, he said, and third-party payors should encourage CTC use as radiologists continue to attend courses to ensure that CTC providers continue to offer high-quality services.

"The public and the medical community at large should work to get this decision reversed," Dachman wrote. ... I am confident that CTC will eventually achieve full reimbursement status."

Urgency of screening

Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer deaths in the U.S. The U.S. Centers for Disease Control and Prevention (CDC) estimates that as many as 60% of deaths caused by colorectal cancer could be prevented if all Americans older than 50 years of age underwent regular screening.

The issue is particularly critical for older patients. Of the approximately 75 million Americans older than 50 who are eligible for colorectal cancer screening, fewer than 50% present for screening due to myriad factors that include, for some, a fear of invasive examination with a colonoscope, which virtual colonoscopy avoids.

Yet patient surveys also suggest that it is the purgative bowel preparation, generally required for virtual colonoscopy and always needed for conventional optical colonoscopy, that patients most dislike about colorectal cancer screening.

Some adults eligible for screening refuse to be examined with optical colonoscopy or cannot undergo the procedure due to contraindications. Virtual colonoscopy advocates believe that Medicare access to VC would improve screening compliance and reduce the death toll from colorectal cancer. Because 90% of colon cancers are diagnosed in people older than 50, they note, colorectal cancer screening is critical for Medicare recipients, who are denied the noninvasive screening option as a result of today's decision.

Private insurance more promising

Although national Medicare coverage may be off the table for now, VC has fared better among private payors. Twenty-six states already mandate that patients with private healthcare coverage are ensured access to virtual colonoscopy. Many regions also cover virtual colonoscopy exams under Medicare local coverage decisions.

Based on early results of the multicenter ACRIN 6664 trial that found equivalent sensitivities for virtual and optical colonoscopy exams, the American Cancer Society (ACS) added CTC to its five-year colon screening guidelines in March 2008.

Other ACS-approved screening exams include optical colonoscopy (every 10 years), flexible sigmoidoscopy (every five years), double contrast barium enema (every five years), annual guaiac fecal occult blood testing (gFOBT), annual fecal immunochemical testing (FIT), and stool DNA testing.

Of these, only virtual colonoscopy remains ineligible for Medicare reimbursement following today's decision. In addition to many physicians and public health advocates, Medicare coverage for CTC is supported by the American College of Radiology, the American Gastroenterological Association, and the U.S. Multisociety Task Force on Colorectal Cancer.

Detractors argue that the evidence remains insufficient to recommend VC screening as a cost-effective alternative to colonoscopy.

In March, the U.S. House of Representatives passed Congressional Resolution 60, calling for increased support for colorectal cancer screening for Americans ages 50 and older. Forty-two representatives also signed a letter to CMS expressing their concerns with CMS' proposed denial of coverage for routine screening with CTC.

The lobbying group CTC Coalition, which includes the Colon Cancer Alliance, the American College of Radiology, and the Medical Imaging and Technology Alliance, argued that Medicare coverage for VC screening would break down barriers to screening for the populations most at risk of the disease.

Observers of all persuasions have complained that a protracted tug-of-war between radiology and gastroenterology interests is more about who will make a living from colorectal cancer screening than the adequacy of CTC. For now, at least, the gastroenterology interests appear to have the upper hand.

Related Reading

Pressure builds on CMS to pay for VC, April 2, 2009

CMS rejects case for virtual colonoscopy reimbursement, February 12, 2009

MedCAC panel members question VC's effectiveness, November 25, 2008

CMS announces VC evidence meeting, September 26, 2008

Brain surgery patient left in OR after doc no-show

I have heard of patients not showing up for surgery - but not a surgeon being there as scheduled.

By FRANK ELTMAN
Associated Press Writer

One of the highest-paid doctors in New York refused to perform brain surgery on an already-anesthetized patient whose scheduled surgeon had failed to show up, and the state health department is investigating.

The surgeon who refused, Dr. Thomas Milhorat, is retiring as chairman of neurosurgery at North Shore University Hospital-Long Island Jewish Medical Center, the hospital said Friday in a statement.

The hospital suspended his and Dr. Paolo Bolognese's clinical practice privileges for two weeks after the cancellation of the April 10 surgery. The hospital said the 73-year-old Milhorat had already been considering retirement and will continue academic and research activities.

The suspensions expired this week, but neither Milhorat nor Bolognese have commented because they are attending a medical conference in Italy. Neither physician has responded to an e-mail request for comment.

Claire Pospisil, a spokeswoman for the state Health Department, confirmed the situation was being investigated.

The unidentified patient was under anesthesia, head shaved, but the 48-year-old Bolognese could not be found, the Daily News of New York reported on Wednesday, citing sources it did not identify.

Staffers contacted Milhorat, who refused to do the surgery because the woman was not his patient. A North Shore spokesman said the woman later had successful surgery.

Crain's New York, a leading business publication, identified Milhorat and Bolognese as among the New York City area's top medical earners in 2007, with Milhorat taking in $7.2 million and Bolognese earning $2.4 million.

They help run North Shore's Chiari Institute, which draws patients worldwide who have a rare congenital brain defect that can cause headaches, dizziness and other pain. It wasn't clear whether the woman whose surgery was canceled had the condition.

Dr. Lawrence Smith, chief medical officer for the North Shore-LIJ Health System, said in a statement that Milhorat "is widely regarded as one of the world's foremost experts on Chiari malformation, and his surgical expertise has benefitted thousands of patients around the world."

Milhorat joined the North Shore-LIJ Health System in 2002 and has been practicing medicine since 1961.

Animated flu virus

I do not know what to make of all the recent news and stories about the Swine/North American/Newly mutated flu virus and how virulent it actually is. 

Nonetheless, The 1x Objective has some nice videos and other links on the proposed pathogenesis for the mutated strain.

Web tracking of swine flu

Google maps, Twitter, RSS feeds, Web sites track spread of flu

April 27, 2009 | Bernie Monegain, Editor, Healthcare IT News

WASHINGTON – Technology of varying types is making it possible to track new cases of swine flu in close to real time.

The Centers for Disease Control and Prevention and the World Health Organization Web sites are posting up-to-the minute information about new cases and recommendations for the public and local and state officials on how to respond to the threat.

The CDC is tweeting updates at twitter.com/cdcemergency. The CDC and WHO are also providing data via an RSS feed, and the CDC is also offering podcasts.

In Mexico, reports indicate that more than 80 people may have died of the flu.

According to the most recent posting on the WHO's Web site Monday morning, the United States has reported 20 laboratory-confirmed human cases of swine influenza A/H1N1 (eight in New York, seven in California, two in Texas, two in Kansas and one in Ohio). All have had mild influenza-like illness, with only one requiring brief hospitalization. No deaths have been reported.

Google maps have pinpointed these cases as they are reported. Google announced last November it would employ its search engines to help the CDC track the flu.

Google queries, officials said, can be counted more quickly. They compared their aggregated queries against data provided by the CDC and found there is a close relationship between the frequency of the search queries and the number of people who are experiencing flu-like symptoms each week.
 
HealthMap aggregates news feeds from the WHO, Google News and elsewhere to map disease outbreaks around the world.  It also offers Twitter alerts on the latest swine flu news.

The CDC is working closely with officials in states where human cases of swine influenza A/H1N1 have been identified, as well as with health officials in Mexico, Canada and the WHO, according to a notice on the CDC Web site Monday. "This includes deploying staff domestically and internationally to provide guidance and technical support," the notice states. "CDC has activated its Emergency Operations Center to coordinate this investigation."

On Sunday, the Department of Health and Human Services declared a public health emergency in the United States. Officials called the measure "standard operating procedure that allowed them "to free up federal, state and local agencies and their resources for prevention and mitigation."