June 29, 2008

Scanning for Dollars

The front page of the New York Times this morning has a don't miss article on the financial incentives behind using CT scans to look for heart disease. Medicare's decided in March to begin paying for the test despite no evidence that it saves lives (see this GoozNews post). The lobbying campaign by a newly created physicians guild that invests in CT scanning clinics is discussed in the last few paragraphs of the story. That campaign was aided by "entrepreneurial guidelines" touting the procedure, discussed in this GoozNews post.

Here are the two key quotes from the story:

"It's incumbent on the community to dispense with the need for evidence-based medicine."

--Dr. Harvey Hecht, Manhattan cardiologist and CT scan advocate

"There are a lot of technologies, services and treatments that have not been unequivocally shown to improve health outcomes in a definitive manner."

--Dr. Barry Straube, chief medical officer, Medicare

Alas, the article does not clearly describe the option that Straube and the Center for Medicare and Medicaid Services rejected in agreeing to pay for the scans. During Mark McClellan's tenure at the agency, he instituted a "coverage with evidence development" program. That in-between option would require physicians using heart CT scans to send in results and monitor their patients over time, sending that follow-up data into the agency, too. This would create a database that could be analyzed to see if CT scans for heart disease and subsequent follow-up care actually reduced the incidence of heart disease mortality.

"We didn't need to be talking about registries and the research," said Daniel S. Berman, president of Society of Cardiovascular Computed Tomography, a society of 4,700 physicians whose sole purpose is to promote CT angiograms, according to the article.

We don't need no stinkin' evidence. We don't need no stinkin' registries. We don't need no stinkin' research.

New leadership at CMS in the next administration at a minimum must insist on creating electronic registries for every new technology that it pays for where there is not yet clear cut evidence that it works. It also should set firm deadlines for manufacturers to submit well-controlled clinical trials offering definitive proof -- or the payments authorized under the coverage-with-evidence-development policy should be revoked.

Posted by gooznews at June 29, 2008 08:26 AM
Comments

What is the appropriate standard to judge medical tests?

1. Efficacy (use of tests improves clinical outcomes)

2. Accuracy (the test accurately measures what they are purported to measure)

Laboratory tests are judged by accuracy and reproducibility and never by their effect upon treatment outcomes. For instance, most tests used today in oncology have comparable "sensitivities" and "specificities."

Pet Scans were not approved because they saved lives in a controlled clinical trial that compared the outcome of patients who received care with or without the benefit of a Pet Scan. They were approved because their performance characteristics (sensitivity/specificity) are reproducible, favorable and provide information to treating physicians.

No test in oncology has ever been shown in prospective randomized clinical trials to improve patient outcomes. The existing standard has always been the "accuracy" of the test. This is true for every single test used in cancer medicine, from estrogen receptors to panels of immunohistochemical stains (IHC) to diagnosing and classifying tumor to Her2/neu and CA-125 to cell culture assays to MRI's, CT Scans, Pet Scans and so on.

So, is there evidence that a CT saves lives? No. No diagnostic/laboratory test ever has.

When you get to the new genetic/molecular tests, even the validation standard that private insurance companies is accepting is "accuracy" and not "efficacy." The essential "proof" is that all they have to do for these tests is that the test has a useful degree of "accuracy," not that the use of the diagnostic test improves clinical outcomes.

However, my contention is that the validation standard the American Society of Clinical Oncology (ASCO) wants for cell-based profiling tests is "efficacy." The cell-based profiling tests have the same entitlement to be judged by the same validation standard as genetic/molecular profiling and all other diagnostic tests. It must be noted that all types of diagnostic tests are just that, "tests" and not treatment.

That's why ASCO needs to update their tech assessment on cell-based profiling assays. And do it transparently this time!

Posted by: Gregory D. Pawelski at June 29, 2008 04:55 PM