November 24, 2004
Progressive Corrective Action Review - Chelation Therapy
The following information is based on a Tennessee specific probe but is being published in the General Release of the Bulletin for the benefit of Idaho and North Carolina providers as well. Progressive Corrective Action (PCA) was developed by the Centers for Medicare & Medicaid Services (CMS) to conduct medical review through sampled claims to validate potential errors and to educate providers concerning the errors. The goal of PCA is to lower the error rate.
Forty claims were selected. The major finding of the review was the absence of documentation to support medical necessity for using edetate calcium disodium (HCPCS code J0600). Inference of heavy metal toxicity was made without appropriate evaluation and documentation of this condition.
What the providers must know:
- Chelation therapy for treatment of arteriosclerosis is not covered by Medicare.
- The screening of asymptomatic 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 E/M 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.
National Coverage Determination (NCD) on Chelation Therapy for Treatment of Atherosclerosis;
National Coverage Determination (NCD) on Ethylenediamine-Tetra-Acetic (EDTA) Chelation Therapy for Treatment of Atherosclerosis);
Title XVIII of the Social Security Act, Section 1862 (a)(7);
Title XVIII of the Social Security Act, Section 1862 (a)(1)(A);
Medicare Benefit Policy Manual, CMS Publication 100-2, Chapter 16, Section 180).
