Autoantibody Testing

Trending overuse of these assays makes patients sick and costs rise

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The ordering of unnecessary autoantibody tests drives up healthcare costs. But more disturbing is the fact that a rising trend of overzealous overutilization and overbundling of these tests can actually make patients sick.

That was one of the overarching messages delivered by Michael Astion, MD, PhD, HTBE, medical director of the department of laboratories, Seattle Children's Hospital, and clinical professor, University of Washington, department of laboratory medicine, during a BioRad-sponsored webinar entitled "Trends in Autoantibody Testing" in October. The webinar was presented in partnership with AACC and Medical Training Solutions.

Defining Autoimmune Diseases
Of course, the nature of autoimmune diseases is partly to blame for the overuse of tests. Astion defined them as "the immunological destruction of tissues by the body's own immune system. They are complex, interrelated, multi-factorial diseases with both genetic and environmental components. They are a 'lightning-strikes-twice' type of situation, because patients with one autoimmune diagnosis are at higher risk for others," Astion said.  About 80 autoimmune diseases have been described -- most are uncommon, but the most common ones include thyroid disease and celiac disease.

"Celiac disease is certainly the most interesting autoimmune disease from a societal perspective because it is simultaneously both the most over-diagnosed and most under-diagnosed disease," Astion pointed out. "This is the first time that has ever happened for a disease -- it is a real societal phenomenon."

He also explained that some autoimmune diseases are primary, some are secondary (for example to cancer). They are characterized by patterns of flares and remissions and are wildly variable. For example, some people get a severe case of lupus and pass away in 6 months -- while others with a mild case live with it their whole lives. "Autoimmune diseases are hard to diagnose, and usually fall into the realm of specialists," said Astion. "They are often treated by immunosuppressive drugs which can have significant side effects, so we don't want to over-diagnose these diseases."

Vague Symptoms Create Problems
Because there are three kinds of circulating autoantibodies -- pathogenic (disease causing), those that are an effect of the disease, and those that are naturally occurring, interpretation of antibody testing is difficult. The diseases and syndromes are hard to pin down at first glance, making symptomatic patients demanding of more tests, more results and faster diagnoses. "What's more, the patients' symptoms are often generic -- fatigue, headaches, hair loss, joint pain -- who doesn't have that?" asked Astion. These factors all contribute to the serious problem of overutilization. Indeed, Astion said the root causes of overuse are:

  • Patients and the "Googlification" of healthcare.  "Patients Google their head pain and after a little reading they think they have Wegener's granulomatosis. So they want an antineutrophil cytoplasmic antibody (ANCA) test -- even though what they really have is a headache," said Astion. Patients also subscribe to a "more is better" philosophy, and are greatly influenced by the "wellness movement" which is driving a lot of allergy and autoantibody testing.  "How ironic that the wellness movement can make people sick," said Astion. "Overtesting in a setting of low pretest probability of disease usually results in positives that are false."
  • Labs and their financial incentives for over-bundling. "Overbundling happens a lot in U.S. reference labs," said Astion. "Examining data from commercial insurers, we see that autoantibody panels include an 'irritable bowel panel.' But in reality, there really is NO test for irritable bowel s. We also commonly see the inclusion of a celiac panel; celiac panels are much too large and lead to a great deal of autoantibody overuse and false positive diagnoses. For celiac, an actual diagnosis requires really one lab test -- two is generous, three is tremendously unnecessary. Yet we have seen one well-known, large reference lab bundling five tests for celiac, 98% of the time. Marketing and sales are oriented to overbundle."
  •  The healthcare system overcompensating for fee-for-service medicine, gene patents and the coding system.
  •  Care providers responding to patient pressure for tests, marketing pressure from labs, fear of malpractice liability, and their own financial incentive.

It's All in the Numbers
The proof of this conglomerate situation, it would seem, is in the data.  "Commercial insurance data culled from one large insurer of over 3.5 million insured people showed that 2.3% had an antinuclear antibodies (ANA) test in a single year -- that is too many for a test used mainly to diagnose lupus that has a prevalence of probably less than 1 in 1,000," said Astion. "So that means these tests are being done in a low pretest probability; healthy people are receiving a certain number of false positives, all while clogging up the healthcare system while really sick people may have to wait for a specialist's appointment, tests and results." He also noted that an examination of ANA tests in the setting of broad workups in this database revealed obvious overuse.  Of 13,000 patients whose doctors ordered 20-30 tests, ANA was ordered for a quarter of those. And for those with mega workups -- 40-50 tests -- 44% had ANA tests. And what was the diagnosis code was? "Simply malaise and fatigue," confirmed Astion.

If there is any one rule of thumb for autoantibody testing as pertains to the trend of overuse, Astion said it is this: "Less is more. The only things overutilization and overbundling lead to is a 'cashectomy' -- the removal of money from a patient's wallet, and a possible false positive leading to inappropriate treatment." Enough said.

 Valerie Neff Newitt is on staff at ADVANCE. Contact: vnewitt@advanceweb.com.


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