Senate OKs mammo mandate; preventive services chief says message was distorted

The controversy surrounding mammography screening guidelines announced in November by the influential U.S. Preventive Health Services Task Force has continued to swirl in the nation’s capital.

The Senate passed an amendment Dec. 3 to minimize the effect of the guidelines on pending healthcare reform legislation, and the chair of the USPSTF admitted in testimony before a House committee that his group did a poor job in communicating what it really meant by recommending that routine screening mammography not begin until a woman reaches age 50. Task force chief Dr. Ned Calonge issued a revised summary of the group’s recommendations Dec. 2.

By a vote of 61 to 39, the Senate approved safeguards for coverage of mammography and other preventive services for women that critics of healthcare reform feared could be denied in light of the new USPSTF mammography guidelines.

The amendment, sponsored by Barbara Mikulski (D-MD) and Olympia Snowe (R-ME), bypasses the preventive services task force by using Health Resource Services Administration guidelines to require Medicare and private insurers to cover cervical cancer screening, annual mammography for women beginning at age 40, and other types of screening exams involving laboratory assays or physician consultation. The Congressional Budget Office estimated the cost of mandated benefits at $940 million over 10 years.

During testimony before the House Energy and Commerce Committee’s subcommittee on health, Calonge admitted that language used to describe recommendations about breast cancer screening was less clear than they’d hoped.

“The task force communication of the mammography screening recommendation for women 40 to 49 was poor,” he said.

The task force still does not believe that women should automatically begin screening mammography after turning 40, but revised guidelines announced during the hearing reflect its intended emphasis on consultations between a woman and her personal physician to evaluate the appropriateness of screening, he said.

Calonge restated the group’s recommendations as follows:

Women, age 50 to74, should have mammography every other year. 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.

“Many doctors and many women, perhaps even most women, will decide to have mammography screening starting at age 40. The task force supports those decisions,” he said.

Calonge defended the USPSTF recommendation against screening mammography after age 75 and its assessment about the harms associated with mammography.

The benefits of screening mammography have been easy to communicate, but the harms have been difficult to communicate, Calonge said. The harms most relevant to the guidelines are associated with follow-up on false positives, namely biopsies for lesions that turn out to be benign, and the inconvenience associated with medical appointments to address false-positive tests and findings, he said.

To this end, Calonge defended the task force’s position about the harm associated with unnecessary anxiety from false positive findings and follow-up diagnostic tests.

“Cancer is a terrifying prospect,” he said. “Breast cancer carries special emotional weight because the consequences of a breast cancer diagnosis, in the past, have been not only the prospect of death due to breast cancer but the prospects of mutilating surgery.”

The anxiety and psychological distress of women who have had a positive screening test is documented, he said.

Calonge told the committee that more research is needed to study cancers that can be detected in a woman’s 40s but do not progress until her 50s.

“These women may have been unnecessarily exposed to the harms of treatment, including surgery, chemotherapy, and radiation, years earlier than necessary,” he said.

Calonge also mentioned radiation exposure as a potential harm. While admitting that radiation exposure during modern mammography is small, the effect accumulates over time with more exams, including those to follow up on false positive tests, he said.

Calonge noted that screening mammography guidelines were developed over two years with a final decision on the language coming in mid-2008, before the presidential election and start of Congressional deliberations about healthcare reform. He emphasized that the decision was based on clinical efficacy. Cost-effectiveness was explicitly not considered, he said.

The USPSTF chief also stressed that draft guidelines were reviewed by selected physician specialists and professional organizations before they were finalized. They included two radiologists, one oncologist, an expert in statistical modeling, a breast surgeon, and three physician epidemiologists. The task force also solicited the views of the American College of Obstetricians and Gynecologists and American Academy of Family Physicians. The American Cancer Society submitted written recommendations, he said.