CIGNA Attacks Chelation Fraud

Stephen Barrett, M.D.
February 23, 2005

The CIGNA HealthCare Medicare Administration, which processes Medicare claims for Idaho, North Carolina, and Tennessee, has concluded that many claim submissions for chelation therapy have been inappropriate. This conclusion was documented by a study of 40 claims which found that in many cases, “heavy metal toxicity” was inappropriately diagnosed and no need for chelation with edetate calcium disodium was documented. This finding is not surprising because many chelation therapists tell patients they are toxic when they are not. On November 24, 2004—to guide providers and claims reviewers—the company published a “Progressive Correction Action Review” that inlcuded the following points.

  • Chelation therapy for treatment of arteriosclerosis is not covered by Medicare.
  • The screening of symptom-free individuals for heavy metal toxicity is not a Medicare covered benefit.
  • Services related to and leading up to non-covered services are not covered under Medicare. For example, if the chelation therapy is not covered, associated evaluation/management services, infusion codes, and laboratory tests are not payable.
  • History of past exposure and nonspecific symptoms and findings in the presence of elevated heavy metal levels in and by themselves do not constitute heavy metal toxicity. An effort corresponding to the standard of practice must be made to corroborate a cause-effect relationship and to establish the diagnosis. For example, the presence of paresthesias is not synonymous with lead neuropathy.
  • The decision to initiate chelation therapy cannot be based solely on specific blood or urine levels but depends on the “whole picture,” which includes the constellation and severity of clinical symptoms and findings.
  • The efficacy of chelating agents in treating patients with subtle neurologic and renal abnormalities has not been established and is therefore not considered medically reasonable and necessary by Medicare’s criteria.
  • The “gold standard” for evaluating acute heavy metal toxicity is the blood level.
  • Although measuring the excretion of heavy metals in the urine after provocation with edetate calcium disodium may demonstrate an increased body burden with previous high-level exposures, this only indicates previous exposure, not past or current poisoning.
  • Treatment with chelating agents may have significant adverse effects. The rationale for initiating and continuing therapy must be solid, in keeping with the standard of practice, evidence based, and well documented in the medical record.
  • Because of the risk of chelation therapy and the complexity of the treated syndromes, Medicare expects providers who render these services to be able to attend to our beneficiaries for the complications of therapy and the underlying condition, to include 24-hour coverage, hospital admitting privileges, etc., as is the standard of practice.

In an independent but parallel development, the Connecticut Department of Public Health has secured a consent agreement barring several of the dubious practices reflected in the CIGNA document. In 2003, Robban Sica, M.D., who practices in Orange, Connecticut, was charged with with improperly using chelation therapy to treat cardiovascular disease, failing to obtain adequate consent for such treatment, and failing to properly manage patients patients whom she said were suffering from heavy metal toxicity. The case was settled with a consent agreement that she will: (a) serve a year of probation, (b) stop using DMPS as a chelating agent, (c) stop using a provoked test to diagnose heavy metal toxicity, and (d) use a patient consent form which states that chelation therapy has not been scientifically substantiated.

For Further Information

This article was revised on February 23, 2005.