Medical Device Daily Washington Editor
WASHINGTON — The recent recommendation by the U.S. Preventive Services Task Force that women between the ages of 40 and 49 should not automatically get an annual breast cancer screening has touched off far more controversy than the report's authors are said to have anticipated, triggering rebuttal from seemingly all corners of American society. Among the concerns that have surfaced is that insurers will scale back coverage of breast cancer screening for women in the fifth decade of life as a result.
As controversial as the report has been, yesterday's hearing in the House of Representatives on the recommendations turned into a referendum on healthcare reform, with Republicans argued repeatedly that the recommendations would result in denial of screening for women between the ages of 40 and 49 if the House healthcare reform bill becomes law. Democrats asserted that those arguments were merely a distraction and that Republicans on the committee were turning the recommendations "into a political football."
During his opening remarks, Rep. Frank Pallone (D-New Jersey), chairman of the health subcommittee of the House Energy and Commerce Committee, tried to temper the controversy around the mammography report, saying, "from what I've heard ... there are a lot of questions, frustration, and accusations" over the report, adding that the rumors "may be eclipsing what was actually said." He stated that some of the questions regarding the task force's work are: "Should they operate with more transparency?" and "Do they consider different opinions?"
"My hope is that we all walk out of this room with a better understanding" of how the task force does its work, Pallone said. He acknowledged what he described as widespread frustration with "the fact that these recommendations were seemingly made" with little input from stakeholder groups, but he took care to put insurers on alert. The report, he said, "should not be used as an excuse to deny care," and reiterated only moments later: "We do not want this study to be used as an excuse by insurance companies" to deny coverage.
Pallone's comments echo portions of the Nov. 18 statement on the issue by Secretary of Health and Human Services Kathleen Sebelius, who went on record as saying that the department's "policies remain unchanged" regardless of the report, but Sebelius added that she would "be very surprised if any private insurance company changed its mammography coverage decisions as a result of this action."
After addressing the controversy over the task force report, Pallone opened the floor to Rep. Roy Blunt (R-Missouri), who said, "I believe it's a huge mistake" to convey the idea "that an early alert system is not beneficial" for detection of cancer. "I know how important screening was for me," he said in reference to his own bout with cancer.
Blunt argued that the task force recommendations run counter to almost every other guideline ever promulgated on the matter, including the task force's recommendations of earlier this decade. Tackling the healthcare reform issue, he said, "I find it unlikely – at least questionable – that a government-run health benefits advisory committee would put into a benefits package a benefit that another government group" has said is unnecessary.
Taking up the task next for the GOP, Rep John Shimkus (R-Illinois) sounded a warning. "Don't be surprised if this is how healthcare is delivered in this country 10 to 15 years from now," he said. He questioned whether in making coverage decisions, "will the new health benefits advisory committee take into account costs?" Shimkus stuck with the argument, saying, "here is proof the government will be able to come between you and your doctor."
Rep. Michael Burgess, MD (R-Texas), said that under a public plan as embodied in the House healthcare reform bill, H.R. 3962, the task force "recommendations carry the weight of law." He also said of the task force recommendations regarding self-examinations, "I can't tell you the number of new cancers brought to my attention" by women who had performed self-checks. "More often than not, there is something there that deserves further scrutiny," he concluded.
Rep. John Dingell (D-Michigan) addressed what he said are "fairy tales from the other side of the aisle," asserting that he was "very much offended to listen to the kind of distorted logic and reasoning." Dingell compared the comments from the GOP members to "the fairy tales of the Brothers Grimm" and said the House bill "does not use these kinds of recommendations to suppress treatment or interfere with relations between patients and doctors."
Rep. Paul Sarbanes (D-Maryland), remarked, "I expect we're going to hear a lot about rationing from the other side." He continued, "to me, the subject is not about rationing. It's about being rational," adding that the task force recommendations "appear to me to be based on extensive study, research and science."
After nearly two hours, the committee got around to interviewing the witnesses who appeared for the hearing. Leading off was Ned Calonge, MD, chair of the U.S. Preventive Services Task Force. Calonge said, "the timing of the release was unfortunate" and that the timing of the release "was not determined by us," but by a publication schedule determined by another entity.
Calonge went to some length to dispel notions of an insulated or insular task force. He said the task force is populated with a range of stakeholders and that the director of the Agency for Healthcare Research and Quality, a post currently held by Carolyn Clancy, MD, is heavily involved in the selection of panelists. "Representatives of 24 partner organizations ... are invited to participate in the discussions," Calonge said, adding, "all comments are considered in creating final products."
Calonge explained that the recommendation for mammography screening for women between 40 and 49 was deemed a "C" recommendation by the task force, meaning that screening of the full population is assumed to offer a very small epidemiological benefit. He acknowledged, however, that the report's description of the recommendation "has played out in unintended ways in public interpretation."
Diana Petitti, MD, the vice chair of the task force, told the committee, "the decision to start biennial screening before the age of 50 should be an individual one" and should be determined by the patient's history and other factors that she and her physician deem relevant. "The task force supports those decisions," Petitti said, adding, "the task force's communication was poor" in terms of making clear this part of the recommendations.
"In making its final recommendation," Petitti said, the task force used data from a variety of sources. "The systematic review identified almost 3,000 studies" most of which were used, she said.
Petitti tackled a seemingly obscure element of the debate in her discussion. "The benefits of breast cancer screening have been easy to communicate, but the harms have been difficult to communicate," she said, remarking that the psychological impact of a false positive is difficult to overstate. "The psychological harms have been ridiculed," she said, but asserted, "a positive screening tests means cancer until cancer" is eliminated by further tests. The amount of time between initial diagnosis and the clarifying follow-up "is not always short," she remarked, and "carries special emotional weight."
Petitti also made the case that "anxiety and psychological distress ... [are] amply documented in the evidence" and that "false positive tests are more frequent in younger women than older women." She concluded her remarks by reiterating the task force's conclusion: "Mammography starting at 40 should not be automatic," but should hinge on discussions between patient and doctor.
Mark McCarty, 703-268-5690