Digital Mammography Saps Medicare Dollars

Below, a guest post from the Center for Public Integrity, one of the country’s oldest and largest nonprofit news organizations. The Center’s mission is to produce “original investigative journalism about significant public issues to make institutional power more transparent and accountable.”  Recently the Center has begun partnering with other news outlets, including the Wall Street Journal, Newsweek and the Daily Beast, to provide the in-depth investigative reporting that the vast majority of newspapers and magazines in our downsized news industry can no longer afford.

Here I am cross-posting a large chunk from a piece which focuses on how “Digital Mammography Saps Medicare Dollars.”  The subtitle reads: “How GE, Others Used Political Muscle, Advertising to Lure Medicare into the New Procedure.” 

For regular Health Beat readers, the second half of the story will be eye-opening. (Scroll down to “A Promising New Technology”).  Most of you know that our health care system  is suffering from what some call “an epidemic” of testing, but few journalists have written about the role that lobbyists for corporate giants such as GE have played in making hospitals feel that they have no choice but to buy exorbitantly expensive, and not always fully tested, medical equipment.

Click on the link to read the full story.

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Unproven for Older Women, Digital Mammography Saps Medicare Dollars

By Joe Eaton and Elizabeth Lucas and David Donald

In 2005, when patients at the Plano, Texas mammography clinic Women’s Diagnostic of Texas began cancelling appointments, the reason why was hardly a mystery. Earlier that year, a Dallas hospital that competes with the clinic had hung a large billboard announcing its new digital mammography machine along the busy North Central Expressway that many Plano commuters drove to work.

Digital mammography manufacturers and hospitals had long run advertisements in women’s magazines suggesting digital mammograms were more effective at finding breast cancer than traditional film tests. They played on emotions with mother and child beach scenes, or showed radiologists and patients peering into a computer monitor at a breast image. “No cold metal. No paper gowns. No old, slow film imaging,” one advertisement proclaimed.

Until the Dallas billboard arrived, managers at Women’s Diagnostic were satisfied with traditional film mammography machines, said Gerald Kolb, then chief knowledge officer at the Plano clinic. But soon patients began leaving for that Dallas hospital in droves. 
“We didn’t want to spend the millions and millions of dollars to make the conversion to digital,” Kolb said. “We had to.”

By 2006, Women’s Diagnostic had replaced its film machines with five Fuji digital units and added a digital system to view and store images. The price tag: around $1.5 million.

The Plano clinic is hardly alone. The fact is, hospitals and clinics nationwide have spent billions converting their mammography units since 2000, when General Electric released the first digital machine to the U.S. market.

But experts say the newer technology has not been proven to improve breast cancer detection, particularly among women 65 and older who make up the vast majority of female Medicare beneficiaries and about a tenth of the Plano clinic’s business.

In fact, for traditional Medicare-aged women, the results of a five-year National Cancer Institute sponsored trial released in 2005 suggest the machines find no more cancers in older women than film mammograms. The trial, which was first reported in The New England Journal of Medicine, was one of the largest to-date to compare digital to film mammography.

The lack of evidence that digital mammography benefits women over 65, however, has not kept radiologists from using it to screen Medicare patients.  An analysis of a six-year sample of Medicare billing data obtained by the Center for Public Integrity and The Wall Street Journal shows that despite its lackluster performance, digital mammography has become the new standard of care in breast imaging for women 65 and older.

Medicare claims for digital mammography skyrocketed during the six years of billing data the Center examined. .. .  In 2003, film mammograms made up all but 4 percent of breast cancer mammography claims. By 2008, digital mammography had trumped film, rising to nearly 53 percent of all mammography claims.

The transition has been expensive: the digital procedure has been reimbursed at the national rate of $129, compared to $78 for a standard film mammogram. . . .

Medical researchers say digital mammography is one of a number of tests that, when considered together, are helping drive Medicare costs while doing little or nothing to make Americans healthier.  .  .

 “We are living in a time when a lot of medical interventions have been oversold, and [digital mammography] is another one,” said Dr. Russell Harris, a professor and preventive medicine expert at the University of North Carolina School of Medicine. “What’s happened is that the people who make the machines, who benefit by selling newer machines, have triumphed.”

And on that path to triumph, the makers of digital mammography machines had plenty of help. The story behind the rise of digital mammography is a tale of intense industry marketing, direct-to-consumer advertising, political lobbying, and strategic campaign donations to politicians who shepherded beneficial Medicare reimbursement rates through Congress, creating the financial incentive for clinics and hospitals to replace film machines with digital.

 A Promising New Technology

In the mid-1990s, when imaging manufacturers met with the Food and Drug Administration to discuss clearing digital mammography systems for marketing, the technology had been under development for more than a decade, with prototypes from General Electric, Fischer Imaging, Fuji Medical Systems, and the Danbury, Conn.-based Trex Medical involved in clinical trials at hospitals.

From the beginning, some doubted digital mammography would improve cancer detection, but many others believed that a clearer digital image would allow radiologists to identify cancers that remained invisible in traditional film mammograms, improving early detection rates.

The government had been an early partner with private industry in the “war” on breast cancer. General Electric, for example, partnered with the Defense Advanced Research Projects Agency (DARPA), the U.S. Army, and the National Naval Medical Center in Bethesda, Maryland, which received an early prototype of the company’s Senographe 2000D digital mammography machine for testing.

“The search for SCUDs in the deserts of Iraq … has more in common with the search for tumors than you might, at first, think,” then-CIA Director James Woolsey said in 1994, during an announcement that the Pentagon, the CIA and other government agencies would turn over military surveillance system technology to private companies developing cancer screening tools.

Even so, the FDA approval process for digital mammography dragged on, pitting manufacturers and breast cancer advocates against the agency, which serves as the gatekeeper for new medical devices. To gain approval, the FDA does not require manufacturers to prove their products perform better than technologies they replace. Instead, manufacturers must prove that new machines are as good and as safe as those already on the market. Cost is not a consideration.

Breast cancer advocates blamed the slow pace on what they called a culture of foot-dragging and secrecy at the FDA. Manufacturers said the FDA set the standards too high to prove digital mammography was equal to film screening, which would require large expensive trials.

To the consternation of breast cancer advocates, American women would not be the first to experience digital mammograms. In 1998, Trex Medical gained approval to market its digital mammography system in the European Union. In 1999, GE gained access to E.U. markets.  That same year, the FDA denied the application of Trex Medical, after determining that its digital mammography system was not equivalent to film systems.

In 1999 testimony before the Senate Health, Education, Labor and Pensions Committee, Amy Langer, then executive director of the National Alliance of Breast Cancer Organizations, warned that FDA missteps could cause manufacturers to give up on digital mammography. “Consumers have read and heard about digital imaging technology for years now,” Langer said, “and women want to try it.”

That same year, Morgan Nields, then the chief executive of Fisher Imaging, told USA Today, “Let’s approve it, and then let the market determine the role of digital mammography.”

Not long after it denied the Trex Medical application, the FDA in 1999 suggested digital mammography manufacturers change their approach and file for market approval under criteria set aside for new devices instead of the criteria for devices that replaced other technology. Soon after, GE won market approval based on a trial of only 625 women. In 2000, the 2000D Senographe went on the U.S. market.

GE celebrated the release of the digital machines with an advertising campaign during the 2000 Summer Olympics in Sydney, Australia. The 30-second television spot featured three middle-aged female radiologists who referred to the machine as “a major new breakthrough in the fight against breast cancer.” The machine, they said, caused less discomfort and less anxiety, while providing radiologists with clear images and “more information.” “That makes a difference to me as a doctor, and as a woman,” said Dr. Debra Mitchell, an Oklahoma radiologist, who stood at a GE mammography machine dressed in a patient’s gown. 

In a recent interview, Mitchell, an early adopter of GE digital mammography, said the company flew her to New York for the taping. She said the advertisement was not well-received in the scientific medical community because of the claims GE made about the machine. “It didn’t meet with great approval,” Mitchell said. “People thought by and large there wasn’t data to back it up.” Mitchell, though, remains a believer in digital mammography. “From my eyes’ perspective, it’s always seemed the way to go.”

The Digital Mammography Premium

Despite the FDA approval and the advertisements, GE faced a stiff challenge breaking into the imaging market. Digital systems in 2000 cost more than $350,000, as compared to about $75,000 for film machines. If insurance payments remained equal for digital and film mammography, it didn’t make sense for hospitals and clinics to make the jump to the new technology. Manufacturers needed a payment boost.

In most cases, the Centers for Medicare & Medicaid Services (CMS) make Medicare reimbursement decisions, which in turn drive the payment rates of private insurers. In the case of digital mammography, however, manufacturers did an end-run around the agency (then called the Health Care Financing Administration) with help from powerful friends in Congress.

In a recent interview, E. Clay Shaw, a former House Republican from South Florida, said he pushed for a digital mammography reimbursement premium after GE held a demonstration of the machine at the Reserve Officers Association near Capitol Hill. Shaw, then a conservative senior member of the powerful House Ways and Means Committee, said GE showed him two mammograms – one a grainy film image, the other a much brighter and clearer digital image.

“It was like it was just ten times ahead of the old style,” Shaw said of the digital image. “You could see the tumors much clearer. I was impressed with what I saw.”

In July of 2000, not long after the GE demonstration, Shaw, whose wife lost her mother to breast cancer, introduced the Breast Imaging Goes High Tech in the Future for Women Act, which would have required Medicare to pay $130 for digital mammograms. The bill died in committee, but Shaw was not discouraged. In September, Shaw introduced the Medicare Access to Digital Mammography Act of 2000, which set the fee at $155. Spencer Abraham, the former energy secretary and Republican senator from Michigan, sponsored a mirror bill to Shaw’s in the Senate.

The American College of Radiology opposed the bill over concerns that a digital premium would suck funding away from traditional mammography, and for awhile the bill languished. But Shaw’s digital mammography provisions were later attached to a Medicare bill that subsequently was itself absorbed by a Health and Human Services budget appropriations measure – a sequence of events that was first reported by The Miami Herald.

When that appropriations bill became law, it established a 50 percent reimbursement premium for digital screening mammograms over film mammograms. According to the Herald, Shaw also won a $1 million earmark for Fort Lauderdale’s Holy Cross Hospital to purchase a GE Senographe 2000D and to conduct a study on the machine’s effectiveness. . .

At the time, some medical imaging industry watchers said they suspected the hand of General Electric in the digital mammography bump. “I’m certain there was a lot of pretty intense lobbying by the blue meatball,” said Gerald Kolb, a long-time industry insider formerly of the Plano clinic, using industry slang for General Electric and its blue logo.

Kolb said it often doesn’t take much arm-twisting to push members of Congress toward supporting increased payments for breast cancer screening and treatments. “It is such a highly-charged issue with women,” Kolb said. “There are congressmen with fairly serious cancer in their families. Some of their wives have had it. So you don’t vote against breasts, that’s pretty clear.”

The legacy of the 2000 premium for digital mammography remains part of Medicare reimbursement policy, and mammographers have avoided cuts that have hit other imaging procedures. In 2005, Congress cut imaging reimbursement by $2.8 billion over five years as part of the Deficit Reduction Act. The cuts hit diagnostic imaging including CT scans, PET scans, ultrasounds and MRIs. Mammography, however, was excluded from the cuts. Medicare currently reimburses a bilateral digital screening mammogram at a national rate of $129, which is $51 more than a bilateral film screening mammogram, although there is some variance in payment rates vary across the country.

Ellen Griffith, a spokeswoman at CMS, said the agency does not have the authority to set prices based on the comparative effectiveness of medical technologies. Instead, CMS pays for tests and procedures based on the [cost of the] resources required to perform them, which in the case of digital mammography are significantly higher than film mammography because of the cost of purchasing and maintaining the machines.

“If it requires more resources, then we pay more,” Griffith said. “We don’t increase or decrease payments based on some kind of clinical assessment of efficacy.”

It does not appear that the 2010 health care law will change that. The law makes a push for federally-funded comparative-effectiveness research, but it also restricts Medicare from using that research to set pricing or limit coverage of a service. . . .

Benefit for Young Women Fuels Jump Among Older Women

If there was a tipping point for digital mammography, experts say it came in October 2005, when researchers writing in the New England Journal of Medicine released the results of a massive five-year trial funded by the National Cancer Institute, the government’s principal agency for cancer research. The Digital Mammographic Imaging Screening Trial (DMIST) gave digital and film mammograms to almost 50,000 women in the United States and Canada, and compared the ability of the two methods to find breast cancer.

The trial found that digital mammography detected more cancers in women 50 and younger, women with dense breasts, women who had not yet experienced menopause, and women in the midst of menopause.

But for older women, a 2008 paper on the DMIST data showed that among women 65 and older with fatty breasts, there was a “non-significant tendency toward film being better than digital mammography,” despite the additional cost of the newer technology.

Harris, at the University of North Carolina, finds the 2008 DMIST results disconcerting. “The trouble is that most breast cancer occurs in older women, not younger women,” he said “If we are going to go after younger women with dense breasts (by swapping film mammography machines for digital) we may actually do a disservice to older women with more cancers. That is the dilemma.” 

Soon after the trial results were released, Dr. Etta Pisano, the principal investigator of the trial, told reporters that for most women there was no reason to seek out digital mammography because film was just as good. “We don’t have enough digital mammography for everyone to get it,” Pisano said, “and some women won’t benefit from it anyway.”

Since then, however, Pisano has changed her mind. Asked about the rapid increase of Medicare claims for digital mammography since 2005, Pisano said that after talking to radiologists who rely on the technology, she now believes digital mammography finds at least as many cancers in all women. Imaging processing has improved tremendously since the DMIST trial began in 2001, Pisano said. She also said the DMIST finding that film mammography was non-statistically better at finding cancers in women 65 and older was likely a statistical fluke, a “sort of an accident.”

“Now you would not get those results because you would use more modern image processing,” Pisano said. “That is my opinion and that is what I really do believe.”

Other prominent cancer prevention experts say improved process does not necessarily mean that digital mammography prevents more women from dying of breast cancer. In 2009, the U.S. Preventive Services Task Force, which was derided by many radiologists and breast cancer advocates for opposing routine mammograms for women aged 40 to 49, found there is insufficient evidence to assess the benefits or harms of digital mammography, regardless of a woman’s age.

Dr. Ned Calonge, the task force chair, said the group reviewed studies including DMIST and “found no evidence that digital was performing better than plain film” when judged in terms of health outcomes.

The distinction between judging imaging technologies based on patient outcomes rather than cancer detection is not a small one. Mammography proponents have long stressed the role that early detection plays in fighting cancer. But Calonge said it may be untrue that simply finding more cancers earlier equates to improved outcomes for women. It’s not the number of cancers that imaging detects, Calonge said, it’s making sure that they find the correct cancers, adding that all screening tests have benefits and harms.

One of the harms of all mammography tests, Calonge said, is they pick up a certain number of cancers that will never harm a woman, leading to needless biopsies and mastectomies in a certain number of women. He said it remains unclear which test – digital or film – better mitigates those risks. “Rather than embrace the new technology, we need to figure out if it works first,” Calonge said.

In a written response to questions about the DMIST trial and the rapid increase of digital mammography billing in Medicare, GE spokeswoman Allison Cohen said the technology has helped “increase the survival rates of millions of women around the world due to timely diagnosis.” Cohen also wrote that DMIST showed the better image contrast of digital mammography “increases the detectability of breast cancer for women with dense breasts who are at the higher risk for developing breast cancer.” She did not, however, reference women 65 and over.

“I’ll Never Have it Done Another Way”

Dr. Otis Brawley, the chief medical officer of the American Cancer Society, said excellent breast care is a question of doctors, not a question of digital versus film.

“Which machine you are using, I don’t really care,” Brawley said.

Even so, it’s clear that some Medicare-aged women prefer the digital test and believe it is better at finding cancers, suggesting that advertising and radiologists who use digital machines have been more effective than the DMIST results or the U.S. Preventative Services Task Force at influencing women’s health care decisions.

Veronica Casano, a 67-year-old retired nurse and social worker in Albany, New York, said she had her first digital mammogram two years ago, after her gynecologist found a “significant change” in a film mammogram. Casano, after waiting through a Christmas break, repeated the test at a digital facility. That test came up clear. Casano said the mammographer at the digital facility told her that the initial film mammogram was poorly exposed.

“Now I will never have it done any other way,” Casano said, adding that the benefit of digital is being able to immediately see if the image has been taken properly. “I had to wait through Christmas and New Year’s even, knowing that I had significant changes. That to me was not fun.”

Casano knows that digital has not been proven more effective at finding cancers for women her age, but she’s willing to live without the proof. “That’s life. I’m willing to accept it,” Casano said.

Sharon Huizenga of Milwaukee, 65, has only recently signed up for Medicare, and like Casano, she prefers digital mammograms. Huizenga reads the monthly Harvard Women’s Health Watch and tries to keep up with the latest data on preventive care. But it’s the images themselves that sold her on digital mammograms. She has seen both her film and digital mammograms and believes that “digital gave a lot more information to work with.”

After Huizenga was informed of the results of the DMIST trial and the U.S. Preventive Services Task Force recommendations, she said she places more stock in the recommendations of clinical radiologists than researchers and epidemiologists. “They know what is easier to look at,” Huizenga said, referring to radiologists.

But health care economists say the problem with “trusting your doctor” comes when radiologists have a financial incentive to prefer digital mammography over standard mammography, regardless of which provides better outcomes for women. When a hospital, clinic or radiologist owns an expensive piece of imaging equipment, economists say they have a financial incentive to maximize billing to help pay for it.

In their advertising, hospitals and breast clinics continue to push digital mammography for all women, not the specific sub-groups that benefitted in the DMIST trial. In one current campaign, LRGHealthcare, a hospital network in New Hampshire, recruited two elderly residents and the executive director of Peabody Home, an assisted living facility, to star in a print advertisement announcing its digital mammography machines. “Digital Mammography – Make the call that could SAVE YOUR LIFE!” the ad proclaims.

Meg Miller, the executive director of Peabody Home, who starred in the ad, defended pitching digital mammography for elderly women. “It’s a little bit more accurate, seemingly,” Miller said. “The digital seems to not have as many shadows.” And Miller said digital mammography cuts down on waiting time at the clinic, which she said will translate into more elderly women receiving an annual mammogram.

Medicare’s Digital Revolution

The greatest consequence of the DMIST trial may have been to sway radiologists who had stuck with film mammography to take the leap to digital. Medicare billing data shows that the largest jump in claims for digital mammography happened in the two years after 2005 when the trial results were released.

Dr. Larry Killebrew, an Oklahoma City radiologist said he wasn’t sold until he saw the clarity of the images available in machines made by Hologic, the Massachusetts company that is now the U.S. market leader in digital mammography. “I wanted to make sure this was the real deal before we jumped out there,” Killebrew said.

By 2007, Killebrew’s Oklahoma Breast Care Center network was entirely digital. Despite his late adoption of the technology, in 2008 Killebrew billed more digital mammography claims than any other doctor in the five percent Medicare billing sample examined by the Center for Public Integrity. Debbie Clark, the center’s executive director, said Killebrew’s 2008 Medicare billing brought in around $535,000, which accounted for roughly 20 percent of the breast center’s business.

Oklahoma Breast Care Center now includes two clinics in Oklahoma City and two recreational vehicles that each put on 100,000 miles a year bringing digital mammograms to businesses and rural hospitals throughout the state. Three small hospitals in the state also send their images to Killebrew to read, which would be impossible with film machines.

Killebrew understands the concerns of people who question the cost effectiveness of digital mammography, but he said if they could see the difference in quality between the images, they would see the difference. “If we can save women’s lives,” Killebrew said, “why would we even dare say that it’s not cost effective?”

Hologic uses stories like Killebrew’s to market its machines. In the fall 2009 edition of its annual “Images for Life” marketing material, Hologic tells the story of Hillcrest Baptist Medical Center in Waco, Texas, which switched to digital and increased its monthly mammogram screening by as much as 23 percent without adding staff or hours. At Oregon Imaging Centers, the Hologic marketing material said, the switch to digital led to a 22 percent increase in patient volume and “increases in additional imaging and diagnostic procedures, such as MRI, ultrasound and biopsy.”

But Clark, the executive director, said Oklahoma Breast Care Center is only a little more profitable after the conversion to digital because the overall cost of a digital operation, with overhead and maintenance, is much higher than film. “The profit margin you think would be there isn’t,” she said.

The profit margin for imaging companies, however, is another matter. In its 2005 annual financial report to investors, Hologic estimated that the U.S. mammography imaging equipment market “may grow to $400 million by 2008 from its introduction only four years ago.” The market, Hologic reported, is being fueled by digital mammography. It appears Hologic was correct. Seventy-three percent of all the mammography equipment in U.S. hospitals and clinics are now digital, reports the FDA. A Hologic spokesman declined to comment for this story.

Experts Say Medicare Digital Premium Makes No Sense . . .

When speaking to radiologists about digital mammography they often compare the advance of digital mammography to digital photography – like with photography, the ship has sailed for digital mammography and there is no going back, they say.

The question that remains, however, is if Medicare should continue to incur the cost. [In other words, does a clearer image save lives, or does it merely detect  what Calonge describes as  “a certain number of cancers that will never harm a woman, leading to needless biopsies and mastectomies”– note from MM]

In 2008, a paper published in Annals of Internal Medicine by the DMIST researchers found that regardless of its possible benefits to women, digital mammography is not cost effective when compared to film mammography.

Nevertheless, “Over time, film mammography is going to cease to exist,” said Anna Tosteson, the lead author. “But here is one thing that’s certain – there is no evidence that one should pay a premium for digital mammography.”

15 thoughts on “Digital Mammography Saps Medicare Dollars

  1. The very last paragraph says it for me, “there is no evidence that one should pay a ‘premium’ for digital mammography.” I wonder if the “fatty tissue” issue could explain why some orthopeds like to use film over digital when it comes to looking at the devices they have implanted in medicare-aged patients?

  2. Digital films parallels our adoption of EMR systems. The data showing either directly benefits care or improves outcomes is incredibly lacking. I suspect neither will ever show it as well. That is not to say either are not without benefits that just aren’t measurablein direct outcomes. Less lost images, less storage, more portability and ease of access. Either one is not the panacea it is made out to be.

  3. One more point. I can understand objecting to increased reimbursement for it, but that’s about it. If you are entirely for film radiography then I suppose you are against EMR. You need both, because it makes little sense to push for nationwide EMR services only to have them interact with 19th century radiographic technology.

  4. Sorry my first post didn’t go through. What I said was this reminds me of EMR implementation. The data showing directly improved outcomes is sorely lacking in either. That does not mean it is not without benefit. It just isn’t measurable in outcomes so far. Same as EMR. It does decrease storage, is “greener”, increases portability and most importantly eases access. As we read in your stent article another set of eyes is not a bad thing. I’m sure most breast surgeons would prefer digital mammography simply for the ease of access of images. Humans are fallible and a radiologist isn’t 100% correct. Ease of access of imaging and multiple viewers and the stent fiasco in Redding probably wouldn’t have happened. I think 100% digital imaging is a worthy goal, it probably should have been implemented like EMR, eventually you won’t get paid for paper or plain films.

  5. Maggie, We may not be getting the best bang for the buck in quality results and safety from all this spending on healthcare, but at least we are getting employment in this sector. Look at this new report that I got the link to from another site.
    Comments about whether this is good or bad, and what if the employment int his sector were to go down with better quality healthcare??
    Private sector health care employment in the United States reached an all-time high of 10.7 percent of total employment, according to a report released by Altarum Institute’s Center for Studying Health Spending.
    http://www.altarum.org/health-systems-research-news-releases/9Feb11-health-employment-record-high

  6. “You need both, because it makes little sense to push for nationwide EMR services only to have them interact with 19th century radiographic technology.”
    There is actually only a very loose relationship between EMR and imaging in general, and mammography especially.
    Digital mammography is still stored on film at many institutions because most places do not have display systems with sufficient resolution to display mammographic images, at least outside the mammography department. The resolution required is significantly greater than the resolution available on most PACS systems, which in turn is much better than the resolution available on EMR displays. The display systems required cost over $50,000 per station just for the display screens, which must have matrix sizes two to ten times as fine as display systems used in other applications as well as software to support that resolution. The solution at most places is to print the mammography digital images on high resolution film, which still exceeds the resolution capabilities of electronic display, and store the film as the ultimate repository of the studies.
    In fact, the display systems on EMR applications are almost always below the legal standards for display of conventional images like chest x-rays, and often below the standard for even CT or MR — which allow lower standards since the resolution produced by the imaging systems themselves is lower. That is not to say that many findings, and certainly most more obvious findings, are not visible on less sophisticated displays, but considerable information is lost in the transition to weaker displays making them not acceptable scientifically and legally.
    EMR systems are good places to store radiology reports, but not good places to store radiology images. That requires more powerful systems, and the systems required for mammography are more powerful even than conventional radiographic systems. Consequently, the interaction of EMR systems and image storage and display systems is not a real issue at this time and is unlikely to be soon, barring a breakthrough in display technology. That is why PACS systems are separate from – and much more expensive unit for unit than – EMR systems.
    Meanwhile, the rapid implementation of digital mammography in the face of evidence that for many women film/screen mammography is still superior as well as much cheaper is a classic case of the synergy between academic physicians who have career stakes in producing papers and presentations touting new and “better” approaches, equipment manufacturers that have financial stakes in selling new equipment, and the media that are eager to trumpet new and better approaches — especially in a high profile area like breast cancer — in order increase their audience to sell advertising. General media and even less rigorously edited scientific sources are very vulnerable to the public relations and marketing departments of research institutions and of vendors. In fact, it is very common for vendors to offer publicity packages for marketing new equipment in local news media as part of the sale of new systems to hospitals and provider groups. It soon becomes impossible to resist the force of public opinion and media excitement, and local radiologists and clinicians are swept along in the wave.
    Throughout my career, radiology has been beset with these types of groundswell adoptions of new technology without good evidence of utility. MRI in particular has been a field in which it has often become the default standard despite evidence that it often adds little except cost in comparison with older imaging techniques or even clinical evaluation, and is sometimes actually inferior.
    Since the clinical utility is a wash, with digital better in young women and film/screen better in older, the only clear advantage of digital mammography is increased throughput, but the value of increased throughput is partly canceled by the increased cost of the systems. Meanwhile, the grateful taxpayers and insurance buying employers are paying the extra expenses.

  7. As to the comment that wasteful spending on health care can be offset by its value as employment stimulus, the fact is that there are many better ways to spend the extra money — education programs, research, infrastructure repair and development, and so on — that will lead to better yields in terms of job creation and ongoing value to society, making that argument moot.
    In fact, even in the area of health care, the savings from resisting a trend like digital mammography could provide much better and more proven health care to people not getting it now. Perhaps even better, if we spent the money wasted on this technology on high quality efficacy research we would be much better off, both as professionals and — as we all will be some day — patients.
    Finally, wasteful and ineffective spending like this will hasten the day — closer, I am afraid, than we would like to think — when quality health care will become inaccessible to not only low income people but to middle class Americans of all ages.

  8. The digital interaction between my EMR system and radiology is invaluable. I would never go back to looking at plain films before I enter each room with the hassle to the patient and staff. Probably 95% I can see what I need to see on the 22 inch computer screen. Pretty much anywhere with a wifi system and the bonus is there is never a lost jacket. Maybe the answer here, would be digitizing film mammograms for the point I was trying to make.

  9. Greg, Jenga,Jenga (your last comment), NG
    Greg– I’m afraid I’m not famliar with the “fatty tissue” issue.
    But as you suggest, the bototm line is that there is no evidence that digital mammograms offer a great benefit that would justify the exgtra cost.
    Jenga–A good parallel.
    And as you say, the lack of evidence regarding the benfits of digital mammography and many of the of EMR savailable now does not provie that these technologies are “without benefit.”
    But we don’t have measurable evidence of benefits affecting outcomes.
    And beter outcomes should serve as the benchmark when deciding to spend more on a technology.
    Finally, at some point in the future, I’m very confident that we will have
    EMRS that provide benefits that clearly justify the cost.
    Today, there are no doubt EMRS out there that are improving outcomes at places like the VA, Mayo and Kaiser. But the for-profit marketplace for MERs is so fragmented, so confusing, and too often, so misleading. . . . We need to have disinterested physician/IT experts sifting through the options.
    Ultimately, a more refined version of Mamography may wel be able to discern between small cancers that will develop, and those that won’t.
    But in the meantime, digital mammography can be dangerously misleading.
    Jegna–(Your last comment)
    You write: ” As we read in your stent article, another set of eyes is not a bad thing. I’m sure most breast surgeons would prefer digital mammography simply for the ease of access of images. Humans are fallible and a radiologist isn’t 100% correct.”
    I I think that the relatively small extra cost of having a second reading, would be well worth it in term so insuring greater accuracy,
    avoiding the cost of unncessary procedures, and most importantly, avoiding the human suffering associated with unncessary procedures. (This second reading would also protect against malpractice suits, and assoicated unncessary costs. For this reason, it might make sense for a radiology lab to institute a policy of two readings–assuming that thye could get a lower rate on malpractice insurance.)
    But I’m not at all sure that digital mammography would serve as a good back-up for regular mammography. Digital mammography is much more likely to spot those small “in situ” cancers– particuarly in younger owmen– which may disappear, or never develop.
    Yet, once a woman know about them, it’s hard to ignore them. .. . This can lead to much unncessary treatment which can be particularly tragic for young women.
    NG–
    First, the point of healthcare is not to create jobs, but to improve the ocmmunity’s health.
    Too often, people try to block a hospital closing because jobs will be lost.
    In most cases, hospitals that are closed just aren’t able to provide very good care: insufficient staffing, bad management, lack of funding for the equipment the hospital needs, a crumbling plant that just cannot be kept clean and free of insects, mice, mold, etc.
    In these hopsitals, patients are harmed–and die.
    Losing a job is one thing; losing your life (or a loved one) is another. .
    Also, whenever we provide unncessary treatments and tests (even in a very good hospital),patients are harmed because they are exposed to risks without benefits.
    Moreover, as Pat suggests, there are so many other jobs that we should be creating.
    Under the Affordable Care Act, we will create many new health care jobs. For instance, new funding for commmunity clincics will incrase their capacity by 50%.
    Perhpas some hospital workers would rather work in a hospital than in a commmunity clnic.
    But what’s important is this: which facility will do more to improve health?
    Also the ACA will reward hopistals that improve patient safety.
    If you can believe it, the most expensive (and most common) hospital “error” is letting patients develop bedsores.
    Once established, bedsores are very, very difficult to treat. Bedsores can go down to the bone–and they can kill. They also lengthen hospital stays and lead to re-admissions.
    Besores are 95% preventable–but someone needs to “turn” patietns regularly (or remind patients to turn themselves.)
    Obese patients are particularly vulnerable to bedsores, and, of course, harder to turn.
    This is something that one nurse probably cannot do.
    Even for two nurses, it can be hard.
    Hospitals need to hire and train more workers to do “heavy lifting”–which includes “turning” obese patients. This is an art
    that has to be taught, but once taught, we could save a huge amount of money– more than it would cost ot hire and train the workers.
    This is just one example of how reform can create jobs that will help patients, replacing jobs that are assoicated with unncessary tests, etc.

  10. Jenga —
    As you probably know,there are two important determinates of image usefulness and quality, contrast and resolution.
    For many types of studies — and most orthopedic applications fall into this group — contrast is more important. EMR system screens can usually provide perfectly satisfactory contrast in many ranges and therefore can display images in a useful way.
    Resolution is very important in certain applications. Mammography is one of those. Legal requirements for mammography display specify that certain resolution standards be met. EMR systems almost never meet those standards.
    If you want to see a good application of the value of high contrast vs. the value of resolution, take a look at a chest xray of a patient with mild congestive failure or other mild interstitial changes and compare what can be seen on the screen of the EMR system and what can be seen on the screens the radiologists use in the xray department. Findings that are easily seen on the higher resolution systems are often invisible on lower resolution. That is why the regulations are in place, and why EMR systems are not currently useful for official storage of many radiologic exams, especially mammograms.
    The differences in performance of film/screen and digital mammography are related to this very issue. Digital mammography can provide superior contrast, but high quality film/screen systems provide superior resolution. The differences in performance relate directly to the strengths and weaknesses clinically, since young women tend to have much more complex breast tissue patterns, giving digital mammography an advantage in detection due to superior contrast, while older women tend to have less complex and more fatty breast patterns, leading to an advantage for the higher resolution of film/screen.

  11. Pat S
    Thanks for pointing this out. I threw this by my brother, a retired radiologist. Just before he retired his group got into digital radiography for mammography, but soon got rid of it because it was promising technology, but not yet ready for prime time.
    Regular mammography was reliable. At the time, digital was not. With a home computer, various glitches in software can be tolerated, but not in the serious business of patient care. Various vendors delivered various results, just like the home computer.
    Practically, there were other problems. How do you rapidly access previous multiple exams and place them side by side with the current exam? At what point do you make the serious investment in the new, rapidly changing electronic world?
    Sending or archiving digital material requires high definition (1032 scan lines, not around 500), so that any EMR would require this, which costs.

  12. Thanks for your comments Pat S. I would suspect that there is a large portion of “comfort” with the read that could be driving this as well. I would give the parallel in arthroscopy. I will never be able to show a study showing HD screens and camera improve outcomes but I would hate going back to standard definition. I could see that a radiologist wouldn’t want to either with the malpractice issues involved. I think the biggest stink on this whole issue is the profitability off these tests and the difference between the two examples.
    Maggie
    You are confident that EMRs will justify their cost. If we are basing this discussion entirely on outcomes. I am not. When some politicians were talking of the thousands of lives they would save implementing EMR systems, I was wondering if they were reading out of something not currently available to the rest of us. I’m a believer in EMR, for my own benefit. It makes my life easier, but to say it makes outcomes better is anecdotal from my standpoint and not backed up by the preponderance of data we currently have. If we based our decisions on entirely on patient outcomes as you suggest, there wouldn’t be a computer containing a single patient record in the US today.

  13. Of course, the underlying question – whether screening mammography is worthwhile – is still out there. The latest Cochrane review, although saying it ‘likely’ reduces mortality, still says:
    ‘…screening leads to a reduction in breast cancer mortality of 15% and to 30% overdiagnosis and overtreatment. This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. Furthermore, more than 200 women will experience important psychological distress for many months because of false positive findings.’
    http://tinyurl.com/6brur8b
    As for digital vs analogue, obviously we would all prefer digital imaging on computer screens and lower dose x-rays (leaving aside the point about resolution), but I’m not sure why digital machines are so much more costly. This comparison by the UK NHS notes that costs come down a lot if you don’t buy lots of laser printers…
    This was done in 2004 so I presume digital costs have come down since.
    http://www.cancerscreening.nhs.uk/breastscreen/publications/er0403.pdf

  14. Jenga —
    Comfort is always an issue in medical practices, including radiology. However, in this case it is not comfort, but legal criteria. Mammography centers undergo regular on site inspections by state regulators and have to undergo regular recertification, including submission of images and of data from regular quality checks as well as certification data for radiologists, techs, physicists, equipment, quality control for both images and for radiologic interpretation, and practices, all under federal government regulation and actual laws passed by congress. Even the wording of reports is subject to regulation and review, and has to comply with specific standards.
    Mammography is even more highly regulated than the management of narcotics, and subject to laws that do not apply to other areas of radiology or medicine. The rest of radiology is policed, like the rest of medicine, by national standards from various organizations and government offices, by requirements of insurers, and by hospital certification units, but mammography is in its own world. It is not at all uncommon, even among academic mammography programs, to have to engage in corrective action following inspections and certifications, and is not unheard of to have units lose the right to perform mammography due to failures of compliance to standards.
    When I say that mammographic images, including storage techniques, have to meet special standards, I mean that they HAVE to meet special standards.

  15. Pat S.,Greg,Jenga,Marc B.
    Pat S.– You wrote: “The differences in performance of film/screen and digital mammography are related to this very issue. Digital mammography can provide superior contrast, but high quality film/screen systems provide superior resolution. The differences in performance relate directly to the strengths and weaknesses clinically, since young women tend to have much more complex breast tissue patterns, giving digital mammography an advantage in detection due to superior contrast, while older women tend to have less complex and more fatty breast patterns, leading to an advantage for the higher resolution of film/screen”
    Thank you–this is very useful information.
    Greg– Thanks for your comment. It does seem that digital mammography still isn’t ready for prime time . ..
    Jenga– On EMRs–
    Yes, there is evidence that EMRs improve outcomes.
    In Western Europe, where EMRs are much more common, hospital errors and medication mix-ups are less common.
    This is also true in this country at medical centers that have a good, functioning IT system — the VA, Mayo Clinic, Kaiser.
    Marc B–
    Good to hear from you.
    Yes, there are still questions about the risk vs. benefit equation for
    mammography.
    I’m not in a position to have a definitive opinion on this question (I just don’t know enough, But I do think that mammography has definitely been oversold.
    The newest recommendation form the Preventive Services Task Force, suggesting that fewer women should undergo mammograms, makes sense.
    Too many young women wind up being treated for tumors that never would have progressed, and that, in some cases, disappear.
    And too many older women undergo painful treatments for breast cancer when they are dying of (or will soon die of) another disease.