By Jenn Q. Public
Cross-posted at http://www.jennqpublic.com/
When I turn 35 I will have my first mammogram.
In the United States, mammography is recommended for breast cancer screening every one to two years beginning at age 40. The best available evidence suggests that mammography screening among women aged 40 to 74 reduces breast cancer mortality.
But due to a few minor risk factors, three doctors have suggested I undergo a baseline mammogram at 35. I’m not thrilled with the idea of having a technician I’ve never met manipulate my breasts into squishing position, but being felt up and flattened out sounds a lot better than being dead, so I’ll take my chances.
Of women who receive annual screening mammography beginning at age 40, six out of 10,000 over a decade will have their lives saved. Breast cancer will be detected and cured in many more, but regular mammograms will only make a life or death difference for six of every 10,000 women in that group. Mammograms are of extremely high value to those women and their families, but don’t offer much bang for the buck when it comes to the other 9,994 women.
And wringing more bang from every health care buck is reason enough for Canadian and British recommendations that women wait until age 50 to begin receiving screening mammographies. In these countries where cost-effectiveness studies influence health policy and medical practice, six saved lives aren’t worth the substantial costs associated with all those extra mammograms and the false positives they sometimes produce.
Canadian women are offered routine mammograms every two years, but only from age 50-69 because “evidence is not conclusive” that routine mammograms benefit younger and older women. Doctors have some leeway with regard to high risk patients.
In the United Kingdom, mammograms are recommended every three years beginning some time between age 50 and 53. Based on guidelines developed by the Orwellian-named NICE (National Institute for Clinical Excellence), the National Health Service insists that for women under 40, “mammograms should only be used as part of clinical trials into screening and that they shouldn’t be used under age 30 at all.” According to NICE, “Healthcare professionals should respond to women who present with concerns but should not, in most instances, actively seek to identify women with a family history of breast cancer.”
It is hardly shocking that the breast cancer mortality is 9 percent higher in Canada and 88 percent higher in the United Kingdom. Nine of 10 middle-aged American women (89 percent) have had a mammogram, compared to less than three-fourths of Canadians (72 percent). And British and Canadian patients wait for care about twice as long as Americans.
There are indeed valid criticisms American health care, but one area in which we excel is that we don’t base guidelines for care on cost-utility analysis. That’s why the U.S. ranks first in providing the “right care” for a given condition and has the best survival rate for breast cancer.
Obamacare may force Americans to give up those bragging rights.
The “right care” may soon be defined in part by how much that care costs. Health care reformers acknowledge the impossibility of implementing universal health care without introducing cost containment measures, and Democrats are enamored with a method used by the British called “comparative effectiveness research” (CER.)
AARP CEO and CER proponent Bill Novelli describes comparative effectiveness research as “a wonky term that just means giving doctors and patients the ability to compare different kinds of treatments to find out which one works best for which patient.” And at its best, that’s just what CER does. CER is not inherently bad. For example, it can help doctors cut through seductive pharmaceutical advertising to identify older, less commonly prescribed drugs that are just as effective as newer, more expensive ones.
But with CER, the devil is in the details.
CER can lead to one-size-fits-all medicine and encourages a purely analytical approach to care that is not always beneficial to the patient. The mythical average patient overshadows the individual patient, leaving most of us with about as many options as a public school cafeteria at lunchtime.
And in the UK, NICE includes cost as a determining factor in the comparative effectiveness studies that inform clinical guidelines. Determinations about whether citizens will have access to drugs, tests, and procedures are based on cost per quality of life year (QALY.)
The QALY score is a fairly crude metric that takes into account both the number and quality of years a medical intervention is expected to add to a patient’s life. Here’s the upshot of using QALYs to determine cost effectiveness:
On the QALY scale, 0 means you’re dead, 1 means you’re in perfect health, and varying levels of debility fall in between. Imagine two groups of people, one with a QALY of 1 and the other with a score of 0.5. An expensive technology brings a year of life to both groups. But in the second, that technology would be counted as having provided only six months, and thus be twice as expensive. It may be deemed too costly for that patient group.
The older you are, the sicker you are, the more disabled you are, the less cost effective it is to treat you. And if the cost per QALY of a medical intervention you need exceeds £20-30,000 (around $32,000 – 48,000), you’re out of luck. Drugs, particularly end-of-life treatments, are routinely rejected for use due to poor cost-effectiveness. And screening tests, like the mammograms American women take for granted, are severely restricted to ensure expenditures remain under the cost per QALY threshold.
Liberal proponents of health care reform accuse conservatives of paranoia and fear mongering about health care rationing. Critics of CER are demonized as extremist spewers of far right talking points who don’t care about improving clinical effectiveness. Surely a uniquely American flavor of a CER board would never become as proscriptive as NICE.
But it seems conservative anxiety (and perhaps a bit of healthy paranoia) is more than warranted by Washington Democrats singing the praises of cost-cutting comparative effectiveness studies. Bear with me while I review some of the health care rationing talk in CER clothing coming from inside the beltway.
The stage for CER to become a significant component of health care reform was set when President Obama’s stimulus bill passed with a $1.1 billion appropriation for CER. In April, Senate Minority Whip Jon Kyl (R-AZ) introduced a budget amendment to ensure that CER would be used appropriately:
Statement of Purpose:
To protect all patients by prohibiting the use of data obtained from comparative effectiveness research to deny coverage of items or services under Federal health care programs and to ensure that comparative effectiveness research accounts for advancements in genomics and personalized medicine, the unique needs of health disparity populations, and differences in the treatment response and the treatment preferences of patients.
The amendment was defeated 54-44.
Last week, members of the New Democrat Coalition proposed HR 2505, a bill to establish a new government bureaucracy called the Health Care Comparative Effectiveness Research Institute. The Institute would prioritize research based on both clinical and economic factors, including “the effect or potential for an effect on health expenditures associated with a health condition or the use of a particular medical treatment, service, or item.” This would not be a problem if there were safeguards to ensure that best practices are not interpreted to mean the least expensive practices.
Officials at National Institutes of Health (NIH) recently announced a stimulus-funded initiative to integrate cost-effectiveness into clinical research. “Cost-effectiveness research will provide accurate and objective information to guide future policies that support the allocation of health resources for the treatment of acute and chronic diseases across the lifespan,” according to the call for proposals.
Back at the White House, President Obama has been paying lip service to the clinical benefits of CER. At the same time, he recently lamented that “the chronically ill and those toward the end of their lives are accounting for potentially 80 percent of the total health care bill … there is going to have to be a conversation that is guided by doctors, scientists, ethicists. And then there is going to have to be a very difficult democratic conversation that takes place.” That, he explained, was part of the need for “some independent group that can give you guidance” on the ethical dilemmas involved with rationing end-of-life care.
During her Senate confirmation process, Secretary of HHS Kathleen Sebelius declined to voice her support for prohibiting the use of comparative effectiveness data to withhold care from patients. Her ideas echo those of Tom Daschle, the tax-dodging health policy wonk who wrote in his book that the U.S. “won’t be able to make a significant dent in health-care spending without getting into the nitty-gritty of which treatments are the most clinically valuable and cost effective.”
Then there’s Peter Orszag, Obama’s director of the Office of Management and Budget and a major player in crafting health care reform. For the most part, Orszag’s commentary on CER has been limited to lauding its ability to improve patient care while reducing waste. But when asked a few months ago if the Obama administration has a position on empowering the CER board to make reimbursement decisions, Orszag said, “Not at this point.”
But perhaps of greatest concern is a January House report that included the following statement on CER funding:
By knowing what works best and presenting this information more broadly to patients and healthcare professionals, those items, procedures, and interventions that are most effective to prevent, control, and treat health conditions will be utilized, while those that are found to be less effective and in some cases, more expensive, will no longer be prescribed.
Sound familiar? Cough, NICE, cough, ahem.
And as Jim DeMint explains, “CER is only one step in the Obama administration’s insidious plan to take over American health care … for our own good.”
But would CER really lead to health care rationing in the United States? Of course. That’s pretty much the point. The debate is not about whether or not CER would be used for rationing, but rather, whether rationing is ethical and useful, and how far we’re willing to go to save a buck and level the economic playing field.
If health care reform shapes up as many Democrats anticipate, CER Institute guidelines will initially apply to the public insurance option expected to be the centerpiece of the Democrats’ proposal. But eventually they would slide down the slippery slope into the private sector. A public insurance option would also ride roughshod over the already anemic competition among overregulated private sector insurers, making the survival of private insurance unlikely. As in the United Kingdom, recommendations will become rules and suggestions will become mandates in order to contain the costs of universal coverage.
To what extent will this result in government control of the doctor-patient relationship? Ultimately, a bureaucratic board will determine when, how, and whether or not you and your family receive care.
Comparative effectiveness research will no longer be just a political hot potato; it will be the basis for the next great American culture war. Instead of clashing over God, guns, and gays, we’ll battle over the monetary value of human life, the sanctity of doctor-patient relationships, the right to medical self-determination, and my favorite hot button issue, the duty to die.
Would cases like Terry Schiavo’s be decided based on financial considerations?
Where will fetuses fall on the QALY scale? How about the elderly or people with Down syndrome? Will they automatically receive limited treatment due to limited resources?
Will smokers be eligible for chemotherapy? Will overweight people have restrictions placed on cardiac care? Will we feel differently about those decisions when we’re footing the bill for everyone?
And you thought the abortion debate was contentious.
Obviously these questions address the most extreme examples of what could happen if we continue on our current path toward universal health care. But government efforts at cost containment through CER may push us toward debating these issues sooner than we think. Hopefully we’ll never see the day when questions like these go beyond an academic exercise.
Autographed Letter Signed,
JENN Q. PUBLIC
*Jenn Q. Public is an ALS guest commentator. She describes herself as “a reluctant republican and recovered democrat who has struggled for years to reconcile my liberal upbringing with a reality that inspires right-of-center beliefs”.
Please visit her blog “Jenn Q. Public“