- The Washington Times - Sunday, September 16, 2007


Nearly 15 years ago, health insurers opposed Hillary Clinton when she tried to give American health care a makeover in the image of the European and Canadian system. Back then, insurers blasted the Clinton proposal as a government takeover of medical decision-making. Today, they support a new federal agency that would decide what is the most cost-effective or best drug or service, and use that as the benchmark for health-care reimbursement.

Mrs. Clinton and the insurance industry like to call this new bureaucracy a “Best Practice Institute.” In fact, it is nothing more than cost-cutting bureaucrats seeking to practice medicine in order to save money, usually at the expense of patient lives and well being.

One could go to Britain or Canada where such government institutes have a small group of underachieving doctors and health economists decide — after a drug has been found to be safe and effective — whether a new product is “worth it.” Such institutes curiously wind up rejecting new drug after new drug for cancer, Alzheimer’s, multiple sclerosis and osteoporosis in favor of older drugs, ignoring individual differences in response and benefit as irrelevant or wasteful.

But why travel when you can find the same lack of thought and compassion in the Center for Medicare and Medicaid Services? Anyone who thinks leadership doesn’t matter should watch as CMS rolls back efforts by its former director, Dr. Mark McClellan, to create a real time system to match the right treatment to the right patient. That visionary enterprise has been shoved aside by bureaucrats all too willing to curry favor with Mrs. Clinton and insurers who see a government “Best Practice Institute” as a great way to sell rationing of breakthrough drugs and devices.

Most recently, CMS issued a best practice decision on the use of drugs known as erythropoiesis stimulating agents (ESAs). These are drugs oncologists have used for 20 years to boost red-blood levels of patients to endure longer, more frequent and stronger doses of chemotherapy. They have made it possible to eliminate repeated blood transfusions in cancer patients, especially elderly and patients who have other illnesses. A study Frank Lichtenberg conducted for the Center for Medicine in the Public Interest found that over the past decade the addition of new chemotherapy agents has extended the life of elderly cancer patients by one year for an additional cost of about $4,600 per person.

It would be nearly impossible to use these new and more powerful cancer drugs in the absence of ESAs. But CMS has used the FDA’s manhandling of some safety data from studies investigating the use of ESAs in healthy patients to justify a one-size-fits-all approach.

Congress and insurers want CMS to emulate what “Best Practice Institutes” around the world do in rendering cost or comparative effectiveness judgments.

CMS has applied one hemoglobin level to millions of cancer patients regardless of cancer type, or of secondary illness or of severity of disease or response to treatment should be treated the same: with as little ESA as possible. Moreover, it has suggested that transfusion-first policy is perhaps “best practice” or most cost-effective.

CMS seemingly focuses on cost control to arrive at its decision. ESAs are not only cost-effective in terms of reducing the risk of infections, recipient rejection of transfusions and administrative costs but also boost an individual’s quality of life. Without ESAs, many patients would simply not tolerate and therefore respond to newer cancer drugs.

CMS also ignored the cost of paying for and maintaining an increased blood supply and transfusion system. A recent Los Angeles Times article noted that less than 5 percent of all Americans donate blood and that shortages persist.

Congress is already backpedaling on best practice. The Senate unanimously (Mrs. Clinton, too) voted to condemn CMS for its ESA decision. The Congressional Budget Office said a “Best Practice Institute” — through programmed to ignore individual differences in response to care — would cost money. Meanwhile, insurers such as California Blue Shield implemented the CMS restriction immediately after it was announced but dropped the plan after patients and doctors found out.

The CMS coverage decision should be a wake-up call to those who thought that Mrs. Clinton’s Best Practice Institute would promote better medicine. Instead, it will create a single reimbursement standard that will be enforced by Medicare and adopted by insurers without regard to patient need or medical progress. Overturning the CMS decision is not enough. Creating a comparative effectiveness board will ensure that patients die waiting for decisions. Best practice? “Katrinacare” is more like it.

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