Every once in a while, a regulatory news story inspires me to bestow upon readers a little bit of medical information. And this time it was an advisory opinion from the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG).
If you watch television, you may be aware that there are now screening tests for colon cancer that do not require you to clean out your colon in a most-unpleasant way. That now includes two tests that use a sample of blood to detect tumor DNA. Because they are Food and Drug Administration- (FDA)-approved, if the test is abnormal, insurers, including Medicare, will cover a colonoscopy as a diagnostic test.
The latest company to release such a test with FDA approval is also proposing to use that same blood sample to look for DNA markers for other cancers – including bladder, breast, esophageal, gastric, liver, lung, ovarian, pancreatic, and prostate – and provide those results to patients.
The problem is that those tests are not FDA-approved, or approved by the U.S. Preventive Service Task Force as a screening test, and there is no data on their accuracy. Now, why is that a problem, and why should we care?
First, let’s look at it from the medical perspective. There are lots of tests that can be done to look for cancer, but the question really is, should we administer them? For example, if you have a couple thousand dollars, with nowhere else to use it, you can get a full-body MRI to look for hidden cancer.
The problem is that one in ten patients will have an abnormal finding, but only one in a hundred will have cancer. That means 90 percent of those with an abnormal finding will have to undergo additional testing, with the associated risk, but without benefit.
Similar findings were found when screening for sudden cardiac death in young people. A British study enrolled 100,000 people, and 2.5 percent had abnormal screening, with half of those needing intervention. But the problem was that most of those who experienced sudden death had negative screening.
Screening all youth with EKGs and echocardiography just isn’t effective.
So, now back to this DNA blood test. The problem we are going to face is what to do with an abnormal result. Let’s say the result indicates that the patient may have pancreatic cancer. They now need either a CT scan or an MRI. But they don’t have a current diagnosis of pancreatic cancer, they don’t have a palpable mass, and they have no symptoms.
All they have is an abnormal, unapproved blood test.
And that means that no insurer is going to pay for the test. And when something is not covered, that’s when the problem gets sent to the case manager to resolve.
And honestly, I have no great answer. I will tell you that as a practicing physician, I occasionally had to do what was necessary to get a test covered. For example, the patient at high risk for heart disease who had exertional jaw pain and a known anginal equivalent needed a stress test, so I was forced to use the diagnosis of chest pain.
So, my advice will be to tell the doctor to do what they need to do.
Now, the other question about this is whether giving patients free tests is considered a kickback, and therefore a compliance risk, but that I will leave to Nina Youngstrom and the Report on Medicare Compliance.
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