A large Medicare carrier's proposal to restrict coverage for vitamin D testing is causing anxiety among endocrinologists.
“This draft local coverage decision in its current form causes grave concern,” Dr. Daniel S. Duick, president of the American Association of Clinical Endocrinologists (AACE), wrote in a letter to Gina Oliveri of National Government Services (NGS). “This policy … would undeniably shortchange current medical practice, and patients who need the test will lose.” The 14 states that would be affected by the proposed policy are Maine, New Hampshire, Connecticut, Massachusetts, New York, Virginia, West Virginia, Ohio, Kentucky, Illinois, Michigan, Wisconsin, Vermont, and Indiana.
The coverage decision for 25-hydroxyvitamin D would provide coverage only for diagnostic testing, not screening tests. It also would restrict coverage to diagnosis of 10 conditions: active rickets, osteomalacia, phosphorus metabolism disorder, stages I through V of chronic kidney disease (CKD), hypercalcemia, and end-stage renal disease (ESRD). The decision also would deny all coverage for 1,25-dihydroxy vitamin D assay as not being medically necessary for any diagnosis, including CKD and ESRD. The list omits “historically acceptable” medical conditions for testing for 25-hydroxyvitamin D such as osteoporosis and secondary hyperparathyroidism, according to the AACE Web site.
The draft decision itself provides a short explanation for the proposed change in policy. “Vitamin D deficiency may lead to a variety of disorders, the most infamous of which is rickets,” it says. “Treatment of vitamin D deficiency is relatively straightforward, negating the need for measuring vitamin D levels in many cases. Evaluating patients' vitamin D levels is accomplished by measuring the level of 25-hydroxyvitamin D. Measurement of other metabolites is not medically necessary.”
This appears to be one of the first attempts by an insurance carrier to restrict testing for vitamin D deficiency, said Dr. Steven M. Petak, past president of the American Association of Clinical Endocrinologists. “If other carriers are doing it, I've never heard of it; we order vitamin D levels frequently for patients at risk for deficiency and have never had a problem.” A search of the Medicare Web site yielded no local or national coverage decisions related to vitamin D testing.
Vitamin D is a critical nutrient for a variety of functions, said Dr. Petak, who is also an endocrinologist at the Texas Institute for Reproductive Medicine and Endocrinology, in Houston. “In addition to the benefits of adequate vitamin D on bone health, it has been implicated in an increased risk of cardiovascular disease, in multiple sclerosis, possibly in some cancers, and a growing list of other disorders. The risk of falls and resultant fractures is increased with vitamin D deficiency because of changes in muscle tone and balance.”
He continued, “The limitations in this proposed coverage decision are incredibly restrictive, and they don't include major disorders such as osteoporosis, hypocalcemia, celiac disease, bariatric surgery patients, and patients who have a history of falls. The list of acceptable diagnoses represents an arcane group of diagnoses that doesn't include what we've known for the past decade about vitamin D.”
The coverage proposal doesn't seem to be based on clinical judgment, he added. “It's a monetary thing. Medicare has probably seen that tests for vitamin D levels are being done in increasing numbers because appropriate awareness among physicians has gone way up, and they are trying to put a lid on it. Unfortunately, the real victims here are the patients.”
When asked for a comment on the draft coverage decision, Todd Siesky, spokesman for WellPoint, the parent company of NGS, said that NGS was still reviewing comments it received on the proposal; the comment period ended on Feb. 21. “We expect to post all comments with responses to each one on April 15, 2009.”
The draft coverage decision is available online at www.ngsmedicare.com/NGSMedicare/lcd/dl29510_c_lcd.htm.