3-D mammograms for all: political gimmickry that may harm more women than it helps

Trudy Lieberman is a veteran health care journalist and regular blogger for HealthNewsReview.org. She tweets as @Trudy_Lieberman.

At the end of New York State’s legislative session two weeks ago, a bill mandating insurers to pay for tomosynthesis, also known as 3-D mammography, passed the Senate, the last hurdle before reaching the governor’s desk. In truth, the bill had no hurdles. No dissenting votes – not in the Senate or in the Assembly, which approved the measure last March. We’ve known for a long time that cancer screening makes for good politics and this latest tale shows how easily good science, or at least the best there is at the moment, is shoved aside in favor of dubious and costly medical interventions that are crowd pleasers at the ballot box.

Tomosynthesis has a history in New York. In March, New York Gov. Andrew Cuomo sent out a news release announcing he had taken action “to expand cutting-edge breast cancer screening options for women.” What New York woman wouldn’t have been delighted by that news? However, the Affordable Care Act already required insurers to cover breast cancer screening, and the New York Health Plan Association, the insurers trade group, said its members already were paying for medically necessary 3-D screenings.

Last year the New York State Legislature passed a bill removing financial barriers to breast cancer screening, forbidding insurers from imposing deductibles and coinsurance for such exams. So Cuomo’s February announcement merely reaffirmed what state law already mandated. It hardly qualified as news. And yet the glowing media coverage made it sound like a brand new benefit was on the way.

However, the most recent June vote by the legislature does elevate breast cancer screening to another level. It cements into law the requirement for insurers to pay for the high-tech approach regardless of medical necessity, “setting up 3-D mammography as a front line screening tool,” says Leslie Moran, senior vice president of the New York Health Plan Association. The bill makes no mention of the usual considerations for screening decisions, such as a patient’s family history or dense tissue or her doctor’s recommendation, all things which might make the high-tech 3-D approach medically necessary. Instead, the bill effectively adds 3-D screening “as a routine procedure for all women,” as Bill Hammond wrote in a blog post for the Empire Center for Public Policy, a conservative think tank in Albany.

Medical evidence changes faster than laws

Codifying screening procedures in law is dangerous business because the science supporting medical tests can change. Take Pap smears. The U.S. Preventive Services Task Force (USPSTF) once recommended yearly Pap tests, but now calls for screening every three years in women ages 30 to 65. New York State law still requires insurers to cover annual tests for women in this age bracket.

New York is about to ignore the science once again. The USPSTF made clear that evidence is lacking for 3-D mammography to be considered a medical necessity in many of the very cases where its use is promoted or prescribed. It made no specific recommendation for 3-D testing, saying that it was not clear that the new technology will result in improved health, better quality of life, or fewer deaths.

H. Gilbert Welch MD

I rang up H. Gilbert Welch, MD, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and an expert on cancer screening. If the best test is judged to be the one that finds the most cancers, he said, then it’s “a recipe for overdiagnosis.”

“The best test is the one that finds the cancers that are really going to matter,” according to Welch. Some small tumors grow so slowly that they may never cause symptoms. “The goal is not to find as much cancer as possible,” he said, and cited the overtreatment of thyroid and prostate cancer. In a study on the overall effectiveness of mammography screening reported in the New England Journal of Medicine late last year, Welch and colleagues concluded, “Women were more likely to have breast cancer that was overdiagnosed than to have earlier detection of a tumor that was destined to become large.”

When it comes to state coverage mandates, science and evidence are pushed to the rear. “Every time I pick up a mandate bill and look closely at it, I find they ignore what the experts say,” Hammond told me. “There’s a perverse political logic behind them. As much as people say they care about the evidence and science, they act on emotion and want to help people who are sick.”

Who benefits from mandates?

However, those helped the most by healthcare legislation often are the ones selling the mandated technology or intervention. The case for 3-D mammography is no exception. Two groups that lobbied for the bill were Memorial Sloan Kettering Cancer Center, the premier cancer hospital in New York City, and the New York State Radiological Society. Both organizations will benefit financially if 3-D mammography becomes a first-line screening tool. The hospital sent a memorandum to the legislature saying it “strongly supports requiring insurers to include digital breast tomosynthesis as a covered benefit,” and argued the technology “has proven to be particularly effective in reducing the number of callbacks in women with dense breasts.” The independent U.S. Preventive Services Task Force says otherwise. It reviewed the evidence for 3-D mammography for effectiveness in screening women with dense breasts, and concluded: “Unfortunately many important questions remain.”

Assembly Member Rebecca Seawright pictured following the New York State Assembly’s 146-0 vote.

The New York bill appears to have come from the hospital itself. According to Our Town, a local newspaper covering the Upper East Side of Manhattan where Memorial Sloan Kettering is located, “the hospital first approached Seawright” – Assembly member Rebecca Seawright – “about the possibility of authoring a bill.” After the bill passed the Assembly and the Senate, Seawright’s news releases quoted Dr. Elizabeth Morris, chief of the hospital’s breast imaging service: “This legislation means that women will have access to this potentially life-saving cancer screening.” The news releases did not mention anything about the technology potentially leading to more unnecessary treatment.

The American Cancer Society Cancer Action Network in New York took no position on the legislation because, spokesperson Marc Kaplan told me, “Our guidelines do not address the 3-D mammography.” When the protocol for the evidence review was developed, he says, there was not enough data to compare 3-D with 2-D mammography.

Society bears the costs, women suffer the harms

New York insurers opposed the measure on the basis of costs and thin evidence. In a memorandum of opposition, they noted that 3-D mammography “is significantly more expensive than traditional mammography” and that no evidence supports its replacement of traditional mammography as front line screening. In February I asked one of my insurance sources to estimate how much 3-D mammography adds to the cost of screening. He ran some numbers for the New York and New Jersey region, already notorious for high healthcare costs, and told me the cost of tomosynthesis could increase the cost of getting a mammogram in hospital settings by slightly more than one-third.

None of that mattered as the 3-D mammography bill spun through Albany’s sausage grinder as far as I could determine. Except for Bill Hammond’s critique on the Empire Center blog, a Politico New York email newsletter citing Hammond’s story, and the puff piece in Our Town, the media spotlight did not shine.

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Comments (3)

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Rebecca A. Zuurbier, MD

June 28, 2017 at 10:22 pm

I write to dispute the suggestion that 3-D mammography is a “dubious and costly medical intervention.” I was surprised to read that your author “rang up” H. Gilbert Welch, MD, to opine on this topic.

Articles that address an issue as impactful as breast cancer detection require a careful review of an expert’s credentials and abilities. Dr. Welch is not trained to interpret mammograms. He is not even a radiologist. He is an internist at the Veterans Administration Hospital (reference White River Junction Veterans Administration Hospital website). He has no training or experience in the field of breast cancer detection and diagnosis. His credibility even in his stated area of expertise -cancer screening- has been challenged (1-3).

Mammography is an effective screening methodology proven to reduce breast cancer mortality (4-6).

My personal experience as a radiologist has been that 3-D mammography is truly a better mammogram. This is supported by now over 250 studies involving tens of thousands of women (7-13). 3-D mammography improves detection of important invasive cancers. For women this means less surgery, less radiation, less disfigurement, less chemotherapy and fewer deaths. 3-D mammography minimizes the financial devastation to a woman and her family that occurs when cancers are found at later stages. This is hardly “political gimmickry.” This technology also results in significantly fewer recalls for additional views (what Dr. Welch calls a “harm”)

Significant cost savings are realized from fewer call backs and increased detection of smaller invasive cancers(14,15). Frankly the fact that this improves women’s health through more accurate earlier detection should be reason enough to support it.

1. Puliti D, Duffy SW, Miccinesi G, et al; Euroscreen Working Group. Overdiagnosis in mammographic screening for breast cancer in Europe: a literature review. J Med Screen 2012; 19(suppl 1):42–56.

2. Kopans DB. Point: the New England Journal of Medicine article suggesting overdiagnosis from mammography screening is scientifically incorrect and should be withdrawn. J Am Coll Radiol 2013; 10:317–319 .

3. Persistent Untreated Screening-Detected Breast Cancer: An Argument Against Delaying Screening or Increasing the Interval Between Screenings.

4. Feig, S.A., Current status of screening mammography. Obstet Gynecol Clin North Am, 2002. 29(1): p. 123-36.
5. Nyström L, Andersson I, Bjurstam N, Frisell J, Nordenskjöld B, Rutqvist LE. Long-term effects of mammography screening: updated overview of the Swedish randomised trials. Lancet. 2002 Mar 16;359(9310):909-19. Review. Erratum in: Lancet 2002 Aug 31;360(9334):724.

6. Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Mortality – All COD, Public-Use With State, Total U.S. (1969-2003), National Cancer Institute, DCCPS, Surveillance Research Program, Cancer Statistics Branch, released April 2006. Underlying mortality data provided by NCHS (www.cdc.gov/nchs).

7. Ciatto, S., et al., Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol, 2013. 14(7): p. 583-9.
8. Friedewald, S.M., et al., Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA, 2014. 311(24): p. 2499-507.
9. Greenberg, J.S., et al., Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice. AJR Am J Roentgenol, 2014. 203(3): p. 687-93.
10. Haas, B.M., et al., Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology, 2013. 269(3): p. 694-700.
11. Lourenco, A.P., et al., Changes in Recall Type and Patient Treatment Following Implementation of Screening Digital Breast Tomosynthesis. Radiology, 2014: p. 140317.
12. Rose, S.L., et al., Implementation of breast tomosynthesis in a routine screening practice: an observational study. AJR Am J Roentgenol, 2013. 200(6): p. 1401-8.
13. Skaane, P., et al., Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology, 2013. 267(1): p. 47-56.
14. Miller JD, et al. Value Analysis of Digital Breast Cancer Screening in a US Medicaid Population. Journal of the American College of Radiology.2017, Apr; 14(4): 467-474.

15. Arleo EK1, Monticciolo DL2, Monsees B3, McGinty G1, Sickles EA4. J Am Coll Radiol. 2017 Apr 27.

    Kevin Lomangino

    June 30, 2017 at 7:55 am

    Dr. Zuurbier,

    Thanks for your comment, but I am compelled to respond to several assertions that I believe are misleading:

    1. One does not have to be a radiologist or be trained to interpret mammograms in order to analyze the evidence on mammography. That’s like saying only certified camera operators are qualified to judge the quality of Hollywood movies. Dr. Welch is an expert in epidemiology, biostatistics, and the evaluation of evidence. He is well qualified to offer an opinion on the benefits and harms of breast cancer screening. He is published in no less than The New England Journal of Medicine on this topic, and I think it’s inaccurate and self-serving for a radiologist to claim that only radiologists are qualified to offer an opinion on this topic.

    2. The issue is not whether mammography reduces breast cancer mortality. I’m sure Dr. Welch would acknowledge that it does. The issue is how big is the reduction compared with the harms of treatment and the number of women who are unnecessarily treated for a cancer that may never have caused a problem. We think women ought to have that information before making a decision to undergo screening. They should also understand that there’s no evidence that mammography reduces total mortality. In other words, while deaths from breast cancer may be reduced, women haven’t been shown to live any longer because of mammography. (There are a number of possible reasons for this, including that treatment for breast cancer is harmful enough that it increases deaths from other causes like heart disease.) So, women should not be told that screening “saves lives” if by “lifesaving” you mean living longer.

    3. I am not aware of any evidence from clinical trials showing that screening all women with 3-D mammograms yields fewer deaths as you’ve claimed. If you are aware of such studies (rather than studies which make projections of fewer deaths that may or may not be justified and may not fully account for harms), please share them. The projection of fewer deaths is an assumption based on the fact that 3-D mammograms find more smaller tumors. How many of those tumors need to be treated, and how many women will be harmed due to unnecessary treatment of slow-growing tumors, is an open question. What we know so far about overdiagnosis in other areas (e.g. prostate, thyroid cancer) should certainly give us pause before rushing to expand the use of an unproven technology like 3-D mammography.

    Kevin Lomangino
    Managing Editor

Susan Danahy, MD

July 18, 2017 at 1:29 pm

Mammographic screening for breast cancer has been proven to reduce breast cancer mortality. Digital Breast Tomosynthesis (DBT, also known as 3-D mammography) is an application of digital mammography that allows for 3-dimensional (3-D) imaging of the breast. It is true that the USPSTF has refrained from making recommendations regarding the use of 3-D mammography. This is because of an absence of randomized controlled trial (RCT) data showing reduced mortality with its use. It would be impractical to conduct such an RCT in the current era, as few women would consent to random assignment to a “no screening” control group, and to detect an incremental all-cause mortality reduction over conventional (2-D) screening mammography, or even an incremental breast-cancer-specific mortality reduction, would require participation of many tens or hundreds of thousands of women with results not available for decades. In the absence of these ideal data, we must rely on data from observational and service screening studies, of which there have been many. These studies consistently demonstrate that 3-D mammography has significant advantages over conventional 2-D mammography, including improved accuracy, increased cancer detection rates, decreased recall rates, and decreased false positive results. Simply put, it’s a better mammogram.

In addition, several studies have shown that 3-D mammography is cost-effective, as there are downstream cost savings. For example, a 2015 study reported a $28.53 savings per woman screened due to the reduction in the number of women recalled for additional follow-up imaging and the ability of 3-D mammography to facilitate earlier diagnosis of breast cancer at less advanced stages where treatment costs are lower.

Dr. Welch’s ideas about screening mammography and overdiagnosis are controversial and have been widely debated and disputed. To whatever extent that overdiagnosis truly exists within a screening population, however, it is really an argument against screening mammography in general, and not against 3D mammography in particular.

It is important to keep in mind that this legislation is not a mandate for women to get 3D mammograms or to be screened for breast cancer if they prefer not to be screened. It is simply to facilitate access for those women who, after discussion of screening options with their health care provider, wish to be screened with 3-D mammography but cannot afford to pay for these exams out of pocket.
It’s also important to note that 3-D mammography is not investigational. The US Food & Drug Administration (FDA) approved 3-D mammography in 2011 for the same indications as traditional 2-D mammography including breast cancer screening, diagnosis, and intervention. Numerous large-scale studies of 3-D mammography have already shown improved performance compared with 2-D. Medicare covers 3-D mammography. Until now, private insurers have frequently denied coverage for 3-D mammography by claiming that the technique is investigational or not medically necessary. Many other states, including Maryland, New Hampshire, New Jersey, Connecticut, and Texas have introduced legislation to mandate insurance coverage of 3-D mammography. New York is not an outlier.

The New York State Radiological Society (NYSRS) is the New York State chapter of the American College of Radiology (ACR). We are committed to reducing breast cancer mortality by optimizing women’s access to effective breast cancer screening. Therefore, the NYSRS supports insurance coverage of digital breast tomosynthesis, 3-D mammography.

Supporting references can be made available upon request.