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New Breast Cancer Guidelines and Managed Care
By now you know the American Cancer Society (ACS) has revised its recommendations for early breast cancer detection in women without symptoms. The ACS no longer advises screening in younger women, and for older women, it suggests less frequent testing.
What are the short-term and long-term ramifications of the ACS’s shift? And what is managed care’s role in clarifying confusion and mixed messages that exist due to conflicting guidelines?
First Report Managed Care (FRMC) asked a group of experts to provide their thoughts.
First, though, here’s a summary of the ACS changes for screening healthy women, and how they stack up against what other organizations recommend.
• Whereas ACS used to recommend starting annual mammograms at age 40, it now suggests beginning at 45. However, it leaves some wiggle room, noting that those 40 to 44 years of age should be able to have annual exams if they want them. The ACS came to this conclusion based on evidence that shows screening leads to false-positives, as well as over-diagnosis and treatment of small, unaggressive tumors.
• It also now recommends every other year screenings starting at age 55, again with the caveat that those who wish to have yearly exams should be able to get them. This recommendation is based on evidence that tumors in older women grow more slowly.
• Finally, ACS no longer recommends clinical breast exams for women of any age. It used to suggest these exams in all women 19 and over. This change is due to evidence that such exams can produce false positives that could lead to more unnecessary testing.
NO IMMINENT COVERAGE CHANGES
The ACS revisions bring its guidelines closer to what the United States Preventative Services Task Force (USPSTF) has recommended since 2009, and recently re-confirmed in an updated release of its guidelines in January. The United States Preventative Services Task Force's advice remains the least aggressive in terms of when to start mammograms and how often a women should get them, whereas the American College of Obstetrics and Gynecology (ACOG) guidelines are the most aggressive.
ACOG says it will convene a consensus conference in January that aims to develop a consistent set of uniform guidelines to help “avoid the confusion that currently exists among the women we treat.” But for now, discordance reigns. With ACOG saying the evidence supports mammography screening beginning at age 40, ACS at 45, and USPSTF at 50, what’s a managed care organization to expect?
Experts we spoke with agree there will probably be no imminent changes.
“Nothing will likely change in the near term as far asmanagedcarecoverageisconcerned,”saysBarney Spivack, MD, a member of the FRMC EAB.
The reason has nothing to do with evidence-based medicine.
There is a provision in the Affordable Care Act that stipulates insurers are obligated to cover only that which USPSTF grades as an A or B. Normally that would mean that payers must pay for mammography starting at age 50. However, Congress has intervened to make sure there is still be coverage starting at age 40 every 1 to 2 years with no copays, coinsurance, or deductibles through 2017.
Catherine Cooke, PharmD, research associate professor at the University of Maryland School of Pharmacy, questions such an intervention. “It’s a situation where fear—and lack of knowledge—drive behavior and also [payment of] benefits through mandated legislation.”
KEEP AN EYE ON THE “WRAP AROUND"
While there will not likely be a change in coverage in the short-term, Dr Cooke, who is also president at PosiHealth, Inc, advises to keep an eye on the so- called “wrap-around.”
“Programs through health plans or employer wellness programs that have been encouraging screening in non-USPSTF recommended populations will likely decrease, along with the rewards and incentives or penalties for those that did or did not have screening,” she explains.
For now, there’s likely to be more watchful waiting, with an eye on eventual change based on data. “Managed care will certainly keep a close eye on the changes and their potential impact on the resulting clinical care that these patients receive—as well as the associated budget,” explains Mitch DeKoven, MHSA, principal, health economics and outcomes research, at IMS Health.
“As accountable care organizations and patient-centered medical homes continue to make inroads, the value of screening—and changes in guideline recommendations—will certainly be monitored, studied, and quantified via outcomes research and other prospective means,” continues Mr DeKoven.
The chief medical officer (CMO) at a national payer, who requested anonymity, agrees with Mr DeKoven that changes will eventually come. “In an ACO environment, providers will need to be educated” to make changes based on the evidence.
Dr Cooke says she believes that “as benefit designs try to encourage appropriate use of health care, copayments or other costs for non-evidence based services may increase.”
EVIDENCE VERSUS EMOTION AND CONFUSION
For Dr Spivack, national medical director, Medicare case and disease management, OptumHealth, the evidence is clear that the major benefits from screening do not begin until at least age 50. He values guidance from the American College of Physicians, which advises periodic risk-assessment in women 40 years to 49 years of age using the National Cancer Institute’s Breast Cancer Risk Assessment Tool. He also relies on the Choosing Wisely campaign—an American Board of Internal Medicine Foundation initiative that seeks to improve the doctor–patient relationships and promote patient-centered care by informing patients and physicians about unnecessary treatments and tests.
“Our organization and others are increasingly concerned about the importance of high-value care—and in minimizing testing and other interventions that do not provide value, based on best medical evidence,” notes Dr Spivack.
Others agree, but acknowledge how challenging it can be to put in practice, be it due to emotion or conflict and confusion.
“[Conducting] preventative tests and exams beyond the current standard of practice is more an emotional issue than one based on evidence,” says Norm Smith, president of Viewpoint Consulting, Inc, which surveys managed markets decision-makers for the pharmaceutical industry. “Everybody is in favor of evidence-based medicine until it contradicts personal or organizational beliefs.”
Dr Cooke agrees. “The medical evidence supports the USPSTF recommendations, but applying these in direct care situations is difficult," she says. "With the growing incidence of breast cancer, there are situations where screening outside of guidelines has identified aggressive breast cancers in young people without any identifiable risk factors.”
But the fact remains, Dr Cooke adds, that there are far more false-positives with associated psychological and economic implications, than there are instances of aggressive disease.
CLARIFYING MIXED MESSAGES
As the evidence shakes out, mixed messages can lead to confusion. At a recent Annual Meeting of the American Academy of Family Physicians, providers spoke up about the problem during a session on over-testing. One, citing mammography and PSA screening, noted that her efforts to reduce testing are in conflict with her hospital’s objective.
“My hospital sends letters to my female patients everyyearremindingthemtogettheirannualmammogram,” she noted. “They also host community-wide PSA screenings. I feel as if I am sticking my neck out if I challenge them. And when I tell my patients they don’t need all these tests, I feel as if I come across as a renegade doctor.”
The CMO at a national payer we spoke with who requested anonymity strongly believes that managed care has a role in clarifying these mixed messages.
Mr DeKoven concurs that managed care needs to use evidence to weigh the value of personalized medicine and precision health to find the “ideal patient population and time for these tests to be deployed [in order to] keep control of potentially future spiraling costs.”
INCIDENTALOMA: AN UNDERLYING FEAR
Part of that spiral, notes Mr Smith, has to do with so-called “incidentaloma,” or uncovering problems that would not be found if the test was not administered. “This is an underlying fear for health plans. There is no actuarial way to account for it, and it’s more common than you’d think.”
At the practice level communication is key. Dr Spivack advises plainly laying out benefits (reduction in mortality rate, reassurance) and potential harms (radiation-induced cancer, false positives, over-diagnosis, pain/discomfort, false reassurance). “Screening decisions for those 40 to 49 years of age should be based on [weighing] the benefits and harms of screening, the woman's preferences, and risk of breast cancer. This should be readdressed every 1 to 2 years,” he explains.
“Mammography is not a risk-free study,” adds Mr Smith. “[Explaining] the risks and benefits of yearly mammography may be a way of softly persuading members that, given the evidence, every other year testing is best.”
In the end, Mr Smith believes that no one should be denied an exam, but he does question who should foot the bill. “If you feel better when you get it done, just pay for it out of pocket.”
