CLIA Regulations Increase Health Care Costs and Create Inconvenience
Dr. Hyatt is a family physician in Payson, Utah.
In 1988 Congress passed a law called The Clinical Laboratory Improvement Act (CLIA), an attempt to improve the quality of laboratory testing done by doctors and hospitals. Although there is always room for improvement, I’m not aware that there was a major problem in this area. Most labs were already doing their own quality controls and internal checks.
It has taken six years for the federal Health Care Finance Administration to implement new regulations, with false starts, trial balloons, and very poor communication to the individuals and laboratories affected. But they are now here, and quickly making their presence felt. Here is one example of how the new regulations have affected private-practice doctors.
CLIA divides all laboratory tests into three categories: low complexity, moderate complexity, and complex. Most doctors will do only low or moderate complexity tests in their offices, while complex tests are usually done in hospitals and reference labs. Now with CLIA, one must pay for permission to do any lab testing. This permission is in the form of a certificate, paid for every two years, and includes a “request” from the lab for an inspection of its facilities and procedures. One must now pay for permission to do what was being done before CLIA, and then pay for an inspector to come and make sure that it is being done according to government standards.
There is a major price break between low and moderate certificates: it costs $100 for permission to do low complexity tests in a lab, whereas it costs $800 for permission to do moderate complexity tests. This price break has become a major point of contention for many private doctors for one reason: strep screens. Strep screens are one of the most common tests done in a doctor’s office, but have been classified under CLIA as “moderately complex.” The test is now so simple that almost anyone with average manual dexterity and common sense can learn in five minutes how to do it. In fact, the procedure is identical to many of the “low complexity” tests, with one major difference, something called “the extraction phase.” This is CLIA’s term for the process of swabbing a patient’s throat with a Q-tip, to obtain a small sample of mucous. It is felt that this step makes the strep test “moderately complex.” The decision to thusly categorize strep tests has come under severe criticism, but so far bureaucrats of the Health Care Finance Administration refuse to budge.
A colleague of mine has become upset with this whole situation, and has vowed to stop doing strep tests in his office, rather than pay the additional $700 for permission to do so. So now, if a patient of his needs a strep test, the specimen is sent to the hospital lab across the street, where it is tested in the “complex” certificated lab there. The interesting point is that now when my colleague needs a strep screen done, he continues to have his nurse do “the extraction phase” (i.e., swab the patient’s throat with a Q-tip), then the swab is transported to the hospital. The patient is sent home and told to await a phone report on the results. What is done in the hospital is the extremely simple part of the test, but the hospital charges more than if it had been done in a low complexity lab, and rightly so, since they have to pay more for the permission to do such “moderately complex” procedures.
So, what has been the net effect of CLIA regulations on strep screens in my colleague’s office? They now cost twice as much, take ten to twenty times longer to complete, and create a delay and inconvenience for the patient and doctor. Hence, they decrease quality of care overall, while increasing costs. Do they accomplish their ostensible purpose of improving quality of the lab tests? Not at all! If anything, the delay, and transportation of the specimen, probably decrease the accuracy of the test.
Perhaps eventually, administrators will catch up with this problem, and devise new regulations to try to prevent it. Probably they will require that my colleague’s nurse be classified as a hospital employee, and require her to go through an expensive training and certification process, along with mandatory increases in paperwork, documentation, wages, and benefits. A private physician such as my colleague would then logically take steps to try to limit his losses, as much as he legally can, and the whole bureaucrat-entrepreneur dance/struggle would begin anew, in an ever-tightening downward spiral towards greater government control and poorer, costlier health
