Task Force Screening Recommendation Creates Chaos

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Public Health Feature - February 2010  

 

Tex Med. 2010;106(2):29-36.  

By  Crystal Conde
Associate Editor  

The U.S. Preventive Services Task Force (USPSTF) learned a valuable lesson when it updated its screening mammography recommendations last November. Arguably a victim of bad timing, and admittedly guilty of poor communication, the task force released the latest guidelines in the midst of the heated health system reform debate.

Task force members likely had no idea the level of criticism and scrutiny they would receive from the medical community, breast cancer prevention and treatment advocates and organizations, and politicians when they published recommendations on routine screening mammography in women aged 40 to 49 at normal risk for breast cancer. The recommendations also discuss the impact of breast self-examination and clinical breast examination on breast cancer mortality. (See " Task Force Recommends Against Breast Self-Examination .")

The furor was so intense that the task force ultimately had to change its recommendation.

In November, the USPSTF issued this guideline: "The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms."

The previous USPSTF mammography screening recommendation came in 2002, when it urged screening all women older than 40 every one to two years.

Lewis Foxhall, MD, chair of the Texas Medical Association's Physician Oncology Education Program (POEP) and associate professor of clinical cancer prevention at The University of Texas M.D. Anderson Cancer Center, is "afraid the recommendation got caught up in all the politics of health reform" as soon as it was released.

Indeed, politicians and the public immediately speculated that the task force's guidelines signaled government intervention in medical decisions and cost control measures that would be commonplace under a reformed health care system. That prompted U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius to assure the public and the medical profession that the task force, an independent panel of physicians and scientists, neither sets federal policy nor determines what services the federal government covers.

Helping fuel the furor was the task force giving mammography for women younger than 50 and at normal risk a grade of C. That means that because limited evidence supports screening of women aged 40 to 49, they should be told the risks and benefits before deciding whether to get a mammogram. That C grade worries some because the health reform bill passed by the House mandates that insurers pay for medical services designated as an A or B by USPSTF. They fear it will give insurers cover to refuse to pay for screening mammograms.

The bills don't prohibit health care payment plans from covering treatments and procedures with lower grades. As the bills are written, Secretary Sebelius could use her authority to require plans to cover treatments with lower grades.

Responding to all the attention surrounding the guidelines, task force Chair Ned Calonge, MD, appeared before the House Energy and Commerce Subcommittee on Health in December. He testified that the task force meant to say that limited clinical evidence supports the test for women younger than 50. He acknowledged USPSTF poorly communicated the guidelines.

On Dec. 4, the task force rewrote its recommendation. It dropped the first sentence so it now reads, "The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms."

A TMA statement on the issue says the USPSTF recommendations and recommendations of other professional health organizations "provide a foundation for individualized discussion between the physician and the patient. TMA believes most physicians who provide preventive and primary care services will continue to follow the current breast cancer guidelines, which are widely recognized and encourage most women to be screened for breast cancer at regular intervals based on her personal history and age."

TMA says it is particularly concerned "about the potential impact of the new USPSTF recommendations on the large number of Texas women who are uninsured and already are more likely to lack access to routine preventive and primary care services. TMA is also concerned that the USPSTF guidelines would be used by third-party payers to deny reimbursement for annual screenings of women starting at age 40."

The statement concluded that the association "supports and encourages the ongoing scientific review of evidence of the benefits of all clinical preventive services to serve as guidelines for physicians providing preventive and primary care services. TMA encourages open dialogue on the new recommendations and will continue to assess the potential impact of the implementation of these recommendations."

 

 

Sloppy Reporting  

Dr. Foxhall also blames sloppy journalism for sparking confusion, because many reporters focused only on the first sentence of the original recommendation. At first glance, and based on numerous media reports, it appeared to many that the task force said no woman in her 40s should bother getting a mammogram.

"The press picked up on just the sound bites rather than really evaluating the full task force recommendation," Dr. Foxhall added. "What this latest recommendation says is that patients in the 40-49 age group, rather than having routine mammography testing, should take time to visit with a physician to ensure it's the right test for them at that age," he said.

Vincent Fonseca, MD, MPH, former Texas Department of State Health Services (DSHS) epidemiologist and a member of POEP's Steering Committee, says the task force's supporting documentation shows it didn't advise women in their 40s to forego a mammogram altogether.

To read the USPSTF recommendations, supporting documents, and model estimates of potential benefit and harm, log on to the Agency for Healthcare Research and Quality (AHRQ)  Web site .

In effect, two schools of thought emerged from the uproar surrounding the task force's latest screening guidelines, says Ann Marilyn Leitch, MD, a member of the POEP Education Subcommittee.

"You have people who actively deal with and take care of patients with breast cancer, and you have public health people who deal with population-based health and determine how to allocate resources for health care," said Dr. Leitch, a surgical oncologist and a professor at The University of Texas Southwestern Medical Center at Dallas. "This type of recommendation gets those two groups debating a subject they're passionate about."

Overall, physicians don't question the value of discussing the risks and benefits of screening mammography. They fear, however, the USPSTF recommendation may result in some women doubting the value of mammography to detect breast cancer, and they worry the newest guidance could give some insurance companies an excuse to drop coverage of the test for women in their 40s.

"We've lived with this for years with insurance companies," Dr. Foxhall said. "They say what will and won't be paid for, and that makes a big difference in how people access services."

However, so far it appears the new recommendations will not cause major Texas health insurers to change their mammogram coverage policies. At press time, UnitedHealthcare, Humana, Blue Cross and Blue Shield of Texas, CIGNA, and Aetna indicated they had no plans to change their coverage policies for screening mammography.

 

 

Recommended, Not Required  

Based on the research it examined, the task force identified the following potential harms of breast cancer screening: emotional distress of having to undergo a biopsy , unnecessary imaging tests and biopsies in women without cancer, and inconvenience due to false-positive screening results. The latter is more common among women aged 40 to 49, because, Dr. Foxhall says, they have denser breast tissue, which makes interpreting mammogram films more difficult.

Acknowledging the potential problems, Dr. Foxhall says the test benefits many patients by reducing mortality and fostering better treatment at the critical early stage of the disease than if detected later.

"Screening isn't perfect, and there are drawbacks with false-positives, but on the whole it appears to do more good than harm," Dr. Foxhall said. "As with any test or procedure, it's a good idea for patients to visit with their doctors and make a decision about screening mammography based on their personal values."

Dr. Leitch says most women would rather undergo a needle biopsy to find that a tumor is benign than forego the screening. She adds that the USPSTF mammography guidelines are only recommendations, not requirements.

"While I personally do believe in screening women for breast cancer in their 40s, the doctor who wants to work with these new guidelines will need to take more time to counsel patients," Dr. Leitch said.

She says the newest guidance from the task force may confuse patients about the value of screening mammography and make more work for doctors who have to take extra time to explain to patients the risks and benefits of the screening.

Taking an individualized patient care approach to screening women in their 40s - while valuable - challenges clinicians, Dr. Foxhall says.

"The reality is that sort of valuable counseling isn't paid for currently. For doctors trying to keep the office doors open, it's difficult to be able to spend time counseling every woman aged 40 to 49 on the benefits and harms of mammograms," he said.

Dr. Foxhall says physicians would benefit from better tools and decision-making aids to allow them to review with patients the pros and cons of screening mammography in a simple and understandable way. He says patients need resources, too, that would help them decide whether to be screened based on their understanding of the test's value.

POEP wants to hear from physicians about tools and resources that would help them counsel patients on when they should begin screening mammography. To submit ideas and feedback, call Stephanie Gonzalez, MHA, POEP project manager, (800) 880-1300, ext. 1469, or (512) 370-1469, or e-mail  Stephanie Gonzalez .

POEP offers a Performance Improvement Continuing Medical Education project for primary care physicians aimed at improving mammography screening rates for eligible women in Texas. Physicians who complete the project will earn 20 AMA PRA Category I Credits ™. At the conclusion of the project, physicians will have the tools to implement evidence-based measures to promote breast health, improve screening rates in the practice, and incorporate prevention into primary care that might translate into other cancer screening initiatives.

For more information about the project, visit the  TMA POEP Web site ; telephone Leslie Jones at (800) 880-1300, ext. 1671, or (512) 370-1671; or e-mail  Leslie Jones .

 

 

Recommendation Déjà Vu  

Dr. Foxhall says when physicians read the fine print of the USPSTF recommendation, plus the  article the task force published in the Nov. 17 issue of Annals of Internal Medicine , they'll realize "it's not a lot different from what has been recommended all along." In fact, the American College of Physicians' (ACP's) Clinical Efficacy Assessment Subcommittee released breast cancer screening guidelines in 2007 that are similar to the USPSTF 2009 recommendation. But at the time, they didn't cause much hoopla.

"The ACP advised shared decision making between the patient and the physician, much like the task force currently recommends," Dr. Fonseca said.

ACP published four screening mammography guidelines for women aged 40-49 in the April 3, 2007, issue of the Annals of Internal Medicine . (See " ACP Mammogram Guidelines for Women Aged 40-49 .")

One difference in the new USPSTF recommendations involves screening mammography of women aged 50 to 74. In the past, the task force recommended screening every one to two years, but it now proposes biennial screening for women of that age. That's based on data projecting that screening every two years produced 70 percent to 99 percent of the benefit of annual screening. In addition, the task force found that "changing from annual to biennial screening is likely to reduce the harms of mammography screening by half."

The task force found that starting screening mammography at age 40 resulted in only "minor improvements" in reducing deaths. The task force projects a 17-percent reduction in mortality due to screening between ages 50 and 69, with an additional 3-percent reduction when beginning screening in women at age 40.

Dr. Leitch opposes applying the biennial mammography screening to all patients. For example, she says tumors tend to grow more quickly in women taking hormone replacement therapy (HRT). She adds physicians may want to consider annual screening of patients on HRT and at increased risk of breast cancer.

ACP identified factors that place a woman aged 40 to 49 at higher risk of developing breast cancer, compared with the average 50-year-old woman. (See " ACP Compares Breast Cancer Risk Factors in Women Aged 40-49 to Women Older Than 50 .")

 

 

Setting the Record Straight  

Numerous health care organizations that support the USPSTF recommendation wrote four U.S. senators in December to "set the record straight about the recommendations and about the task force itself."

Signing the  letter  [ PDF ] were the American Medical Association, American Academy of Family Physicians, American Academy of Nurse Practitioners, American Academy of Physician Assistants, American College of Physicians, American College of Preventive Medicine, American Journal of Preventive Medicine, American Public Health Association, National Association of County and City Health Officials, Partnership for Prevention, Public Health Institute, and Trust for America's Health.

According to those groups, the three most common misstatements by the media are:

  • The task force recommends against mammograms for women aged 40 to 49.
  • The intent of the task force recommendations was cutting cost by reducing the number of mammograms women would receive.
  • Members of the task force are not qualified to make scientific recommendations, or they have other agendas at play.

To address the charge USPSTF tried to cut costs via fewer mammograms, the groups said USPSTF "never uses cost as a reason to recommend against a service that has been proven to be effective. … For each preventive service it reviews, the task force assesses the quality of the scientific information, estimates the magnitude of benefits and harms, reaches consensus about each service's net benefit, and issues a recommendation."

To view the criteria the task force uses to develop recommendations, click  here .

Dr. Leitch says that while the task force doesn't look at the actual cost of the procedure, it does focus on the number of tests performed, which, she says, implies costs. For instance, the task force found that to save one life, 1,904 women aged 40-49 must be screened annually. Screening 1,339 women in their 50s annually saves one life.

"The task force determined the amount of screening mammography necessary to save the life of one woman in her 40s wasn't worth it. It's not worth it because of the cost and the amount of manpower related to screening that many people," she said.

Dr. Leitch says considering cost isn't wrong, but the public must understand that the task force takes into account allocating limited resources to do the most good for the most people.

Dr. Fonseca says that when determining how to reduce mortality most effectively given limited financial resources, it makes sense from a public health standpoint to screen the patient population that will benefit most, while decreasing the risk of harm. The task force found that screening mammography yields a greater reduction in breast cancer mortality for women aged 50 to 74 than for women aged 40 to 49.

He says focusing screening on those who benefit most will help Texas make sure more women have received a mammogram in the past two years. Data from the 2006 Texas Behavioral Risk Factor Surveillance System (BRFSS) show Texas falls behind the United States in the prevalence of women aged 40 and older who have had a mammogram in the past two years. (See " Texas Lags Nation in Mammograms .")

There are no oncologists or breast cancer experts on the 16-member task force. But to clear up any questions about the task force members' qualifications or their motivations, AMA and others say in their letter that most of them are skilled clinicians, as well as experts in prevention research. AHRQ appoints the task force's members, many of whom "were nominated because of their expertise in prevention, primary care, and evidence-based medicine without regard to political views or influence." The letter concludes that the task force members base their decisions solely on scientific evidence.

That doesn't impress Ray D. Page, DO, PhD, a member of the POEP Steering Committee and a Fort Worth oncology specialist. He says he tends to follow recommendations from medical specialty societies, as well as panels and groups composed of breast cancer experts.

"I'm sure the members of the task force are nonpartisan and nonbiased, but I look at that group and notice they're not breast cancer experts. It's hard for me to take the recommendation from a panel with no thought leaders in breast cancer," Dr. Page said.

Dr. Page does agree with the task force's recommendation that the decision on when to begin screening mammography for women in their 40s should involve shared communication between the doctor and the patient.

 

 

Weighing In  

The American Cancer Society (ACS) reports that in 2009 more than 40,000 people died from breast cancer, and there were 192,000 new cases of invasive breast cancer. ACS credits earlier screening and improved treatments with a declining death rate from the disease. And, the organization continues to recommend women get a mammogram every year, starting at age 40.

Otis W. Brawley, MD, ACS chief medical officer, says beginning screening mammography at 40 saves lives.

"As someone who has long been a critic of those overstating the benefits of screening, I use these words advisedly: This is one screening test I recommend unequivocally, and would recommend to any woman 40 and over, be she a patient, a stranger, or a family member," he said.

In December, the  Cancer Prevention and Research Institute of Texas (CPRIT) joined Texas First Lady Anita Perry in supporting screening mammography for women at average risk for breast cancer beginning at age 40. CPRIT recognizes there is debate over when it's most appropriate for women to begin mammography screening.

Alfred G. Gilman, MD, PhD, CPRIT's chief scientific officer, says the debate highlights the urgent need for research into better risk assessment models, as well as better screening and detection. CPRIT's priority populations for breast cancer screening include women who are underinsured and uninsured, geographically or culturally isolated, and medically unserved or underserved, and women who have never been screened or not screened in the past five years.

Access to health insurance does affect whether a woman older than 40 has had a mammogram in the past two years. According to data from the 2006 Texas BRFSS, 77 percent of women with health insurance had a mammogram in the past two years, compared with 41 percent without insurance.

Dr. Fonseca says these data illustrate the need for a concerted public health effort to target women at greater risk of breast cancer and who are less likely to be screened, such as those without insurance.

"I hope that private insurers see the value in this lifesaving test and continue to pay for mammography screening of women in their 40s," Dr. Leitch said.

Dr. Page echoes Dr. Leitch's sentiment and says that if insurers are smart, they won't restrict coverage of mammograms for women in their 40s.

"Breast cancer survivors are an active and vocal group," he said. "Insurance companies don't want to wake that sleeping dragon."

Crystal Conde can be reached by telephone at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by-email at  Crystal Conde .  

 

 

SIDEBAR  

Task Force Recommends Against Breast Self-Examination

The U.S. Preventive Services Task Force (USPSTF) says adequate evidence suggests teaching breast self-examination doesn't reduce breast cancer mortality.

However, Ray D. Page, DO, PhD, a member of the TMA Physician Oncology Education Program (POEP) Steering Committee specializing in oncology, says breast self-exam may affect breast cancer morbidity. There is no research on the effect of breast self-exam on breast cancer morbidity.

"It's not going to hurt for a woman to do a breast self-exam," Dr. Page says. "The bottom line is if I have patients who are more educated and more aware of changes in their bodies - regardless of what they may be - those patients are going to have a better chance at early detection."

Lewis Foxhall, MD, POEP chair and associate professor of clinical cancer prevention at The University of Texas M.D. Anderson Cancer Center, adds that while research fails to indicate breast self-exam reduces morbidity from breast cancer, he agrees with Dr. Page that patients should pay attention to changes in their breasts.

"We all know women who have discovered their own breast cancer from a breast self-exam, so it's important for women to have familiarity with their breasts," Dr. Foxhall said.

USPSTF also found insufficient evidence to assess the additional benefits and harms of clinical breast exams by doctors. The task force suggests that clinicians committed to spending the time on clinical breast examination consider a structured, standardized approach.

Vincent Fonseca, MD, MPH, former Texas Department of State Health Services epidemiologist and a member of POEP's Steering Committee, says clinical breast examination has tremendous variability, including the potential for false-positive results. He concurs with the task force's guidance and advises physicians to seek out and implement thorough and systematic methods for conducting the exams.

Back to article  

 

 

SIDEBAR  

ACP Mammogram Guidelines for Women Aged 40-49

  • Clinicians should periodically assess the risk of breast cancer in women aged 40-49 to help guide decisions about screening mammography.
  • Clinicians should tell them about the potential benefits and harms of screening mammography.
  • Clinicians should make screening mammography decisions involving the women based on the benefit and harm of screening, as well as on their preferences and breast cancer risk profile.
  • More research should be conducted on the net benefit and harm of breast cancer screening for the women.

Back to article  

 

 

SIDEBAR  

ACP Compares Breast Cancer Risk Factors in Women Aged 40-49 With Women Older Than 50

  • Two first-degree relatives with breast cancer;
  • Two previous breast biopsies;
  • One first-degree relative with breast cancer and one previous breast biopsy;
  • Previous diagnosis of breast cancer, ductal carcinoma in situ, or atypical hyperplasia;
  • Previous chest irradiation; or
  • BRCA1 or BRCA2 mutation.

Back to article  

   

 

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