ACLA Pushing for Broadening of Coverage for Vitamin D Testing

The American Clinical Laboratory Association (ACLA) has asked regional fiscal intermediary Novitas—and by extension, much of the Medicare program—to reconsider its austere position on testing for some vitamin deficiencies. In particular, the ACLA has asked Novitas to reconsider its position regarding testing for vitamin D.

"Vitamin D deficiency is an important contributor to the development of osteoporosis; specific patient populations with specific diagnoses are at substantially increased risk for complications related to Vitamin D deficiency," said the comment letter the ACLA sent to the Pittsburgh-based Novitas and authored by ACLA Senior Vice President JoAnne Glisson.

Currently, Medicare does not reimburse for many forms of vitamin or micronutrient testing, considering such tests to be medically unnecessary. It makes a few exceptions for patients with specific diseases or medical conditions, but they are generally narrow.

The draft local coverage determination released by Novitas mostly reiterates that position: "Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors."

However, the aging U.S. population has seen an uptick in the cases of osteoporosis, a weakening of bone density that can lead to serious fractures often requiring hip replacements and other expensive orthopedic surgical procedures. Cases of osteopenia— a precursor to osteoporosis—have also risen in recent years. According to data from the National Osteoporosis Foundation, as many as 54 million Americans over the age of 50 either suffer from osteoporosis or relatively low levels of bone mass that put them at risk for developing the disease later in life. That's about 60 percent of that particular age demographic in the U.S.

The ACLA noted that vitamin D deficiency can be linked to individuals undergoing bariatric surgery to address severe obesity. Such procedures rose nearly 15 percent between 2011 and 2013, with 179,000 such procedures performed in the latter year, according to statistics from the American Society for Metabolic and Bariatric Surgery.

Vitamin D deficiencies have also been linked to patients suffering chronic renal disease, as well as those taking steroids and cholesterol-lowering medications over the long-term.

Although the draft LCD currently provides testing coverage for Medicare enrollees diagnosed with rickets, osteomalacia, osteoporosis, chronic kidney disease and some digestive disorders such as irritable bowel syndrome and Crohn's disease, the ACLA wants coverage to include other patients as well.

The organization is asking for coverage of patients who have been diagnosed with cystic fibrosis, undergone bariatric surgery or suffered from radiation enteritis—an inflammation of the digestive system due to radiation treatments for cancer. It is also asking for coverage for patients diagnosed with several forms of lymphoma and histoplasmosis.

ACLA is also requesting some clarity regarding coverage for patients who are taking certain drugs. "We note ... that many times clinicians will report the condition for which those drugs are used rather than the chronic drug use codes," Glisson wrote. "For some of these medications (e.g., HIV therapy, anticonvulsants) there would be a very clear map to the condition for which those drugs are prescribed. We would recommend, therefore, incorporating those conditions into the LCD."

Although vitamin testing is a relatively low-cost assay, if it's adopted as part of routine preventive care, tens of millions of such procedures could be performed in the U.S. and eventually be extensively covered by the Medicare program and Medicare Advantage payers.

Takeaway: The ACLA and other laboratory lobbies are pushing to try to get a longstanding Medicare coverage ban on vitamin testing to be lifted.