The Government's New Recommendations for Breast Cancer Screening:
Sensible advice or incipient rationing?
18 Nov 2009 in Regulatory Policy, Information Quality
The US Preventive Services Task Force issued a report with revised recommendations calling for much less frequent use of mammograms for screening women with no risk factors for breast cancer. The announcement triggered an extraordinary reaction, most of which was negative.
Few of those reacting had actually read the report. In many cases, the complaints were factually inaccurate -- by that we mean they objected to things that were not in the report.
What happened?
The federal government is in two businesses with potentially conflicting interests. First, it funds biomedical research and thereby generates scientific knowledge, primarily through the National Institutes of Health. This is supposed to be an objective, scholarly enterprise. Scientists come up with testable hypotheses and devise laboratory, clinical and epidemiological studies to refute them. This is painstaking work, and to the public at large, it's mostly boring.
Second, the federal government funds health care, primarily to the aged through Medicare and the indigent through Medicaid. The federal agency that regulates these programs, and decides how much to pay for physician and hospital services and medical goods, is the Centers for Medicare and Medicaid Services.
These missions conflict. Generating knowledge leads to more medical therapies, and that often raises health care costs. This is the main complaint made by politicians and consumerist interest groups about pharmaceutical companies. So it should not be surprising that a wide swath of the public now treats the government with the same skepticism when it appears to suffer from the same conflict of interest.
What is the US Preventive Services Task Force?
The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984, and since 1998 sponsored by the Agency for Healthcare Research and Quality (AHRQ), is the leading independent panel of private-sector experts in prevention and primary care. The USPSTF conducts rigorous, impartial assessments of the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening, counseling, and preventive medications. Its recommendations are considered the "gold standard" for clinical preventive services.
The mission of the USPSTF is to evaluate the benefits of individual services based on age, gender, and risk factors for disease; make recommendations about which preventive services should be incorporated routinely into primary medical care and for which populations; and identify a research agenda for clinical preventive care.
This mission may be internally conflicted. The Task Force is supposed to synthesize biomedical information related to disease prevention within the population at large (a scientific task) and make policy recommendations concerning the clinical practice of medicine (possibly a policy task). To the extent that CMS adopts these policy recommendations, the work of the Task Force is clearly regulatory, and profoundly so If private insurers do the same. This is not a problem if CMS is excluded from the process; it is problematic, however, if the interests of third-party payers such as CMS are given any weight.
With the breast cancer screening report, the Task Force has experienced a public relations disaster. There are three big reasons why.
First, there is no obvious reason why the public should trust the Task Force. Hardly anyone has every heard of it or know its members. The Task Force has issued dozens of recommendations, and this may be the first time a recommendation caused a storm of controversy.
Americans tend to be respectful of medical expertise but reticent about giving up the authority to make their own medical decisions. The prospect of the federal government taking a controlling role in health care financing and regulation intensifies this reticence, and to the extent that physicians and nurses participate in this, they should expect that deference to their expertise will decline.
Second, as noted above, the Task Force has potentially conflicting roles. It synthesizes biomedical science but it also makes policy recommendations. The good news for a skeptical public is that these recommendations are graded in terms of their relative "net benefit" to patients:
The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population.
In the case of breast cancer screening, this means the Task Force is estimating the benefit from early detection and subtracting the costs to patients of "false positives" -- mammograms that detect abnormalities interpreted as cancer that prove to be benign. These costs include unnecessary surgery and significant anxiety associated with an apparently positive x-ray.
Cost to the government (or to private insurers) is not listed as a factor in the Task Force's methodology. In fact, financial cost is explicitly excluded from the Task Force's net benefit calculation:
Although opportunity costs may be considered in the Task Force's letter grades, financial costs are not. The Task Force understands, however, that many of its audiences are interested in issues of financial cost. In situations where there is likely to be some degree of health benefit, the Task Force searches for information about costs and cost-effectiveness and provides a summary of this information under "Other Considerations" in its recommendation statement. (5.4.2)
The third reason for the Task Force's public relations disaster is coincidental. What the Task Force does is very similar to what proposed federal legislation would institutionalize on a grand scale. Each of the bills would create a new Center for Health Effectiveness Research, and devotes many pages to the calibration of procedures that the Center would be required to follow. That's the hallmark of a future regulatory program.
The proposed Center has been controversial, and the Task Force is today's precursor. Each of the bills would permit both CMS and the new regulator of private insurance plans to use Center research to decide which medical procedures, pharmaceuticals and devices to cover and which to exclude. Whereas the Task Force's procedures do not appear to include a substantive or procedural bias against any type of medical intervention, the proposed legislation is at least procedurally biased against pharmaceuticals. And whereas the Task Force has an established methodology that excludes the consideration of costs borne by third parties, nothing in the proposed legislation would ensure that this practice was retained.
When considered in this light, it should not be surprising that the Task Force report on breast cancer screening has generated such controversy. Whether deservedly or not, the report was caught up in the controversy over health care legislation. The Task Force may well have been blindsided if its members never saw how its recommendations would be interpreted in such a politically charged environment.
The Task Force can recover from this, but it will take an extensive (and expensive) effort to educate the public about its work. It also may require changes to the proposed legislation -- changes that expressly prohibit the consideration of costs to third-party payers, such as the government. That change would remove from the debate most doubts about the proponents' intentions.
