The medicare contractor for Region IV, Trailblazer Health Enterprises, recently proposed an unduly restrictive Local Coverage Determination (LCD) for laboratory tests to detect deficiencies of vitamins, minerals, and other nutritional components (4L-116AB “Assays for Vitamins and Metabolic Function”). This would be the most restrictive policy in the nation regarding tests for vitamins and minerals, and is based upon premises which appear to be scientifically unsound. Unless this LCD is delayed or revised, the policy is scheduled to become effective August 16, 2010 and will limit physician's patient’s coverage to one vitamin, mineral or antioxidant test. In summary, this proposed policy states:
"Medicare considers vitamin assay panels (more than one vitamin assay) a screening procedure and therefore, non-covered. Similarly, assays for micronutrient testing for nutritional deficiencies that include multiple tests for vitamins, minerals, antioxidants and various metabolic functions are never necessary...Many vitamin deficiency problems can be determined from a comprehensive history and physical examination..."
SpectraCell has formally advised Trailblazer that this policy appears to be unreasonable, and is in conflict with current scientific and medical evidence.
It is well known that physicians often find it reasonable and necessary to order multiple tests to detect deficiencies of vitamins, minerals and antioxidants (and such a position is fully supported by the scientific literature). On a routine basis, for example, physicians commonly order tests for vitamins B-12 and folate simultaneously, as is the case for vitamin D and calcium, or similarly for calcium, magnesium, and zinc. On a less routine basis, physicians such as you who are particularly well-versed in the clinical relationships between nutritional deficiencies and disease processes may frequently find it reasonable and necessary to order a broader range of nutritional tests, including, for example (in addition to those mentioned above), varying combinations of vitamin A, vitamin C, vitamin K, vitamin E, vitamin B-1, vitamin B-6, copper, selenium, chromium, glutathione or coenzyme Q-10. Each of these physician’s orders – based on the physician’s determination of medical necessity – would be denied coverage under the proposed Trailblazer policy solely because more than one test is requested.
If you agree with our position that this policy is unreasonable, we encourage you to express your opinion to Trailblazer.
Trailblazer Health Enterprises, LLC
Attention: Medical Directors
Executive Center III
8330 LBJ Highway
Dallas, TX 75243
