New Study to Research if Supplements of Vitamin D, Fish Oil Reduce Health Risks
With the volume of Vitamin D testing skyrocketing in clinical laboratories across the nation, leave it to government bureaucrats to work at counter purposes to each other. With one hand, the federal Medicare program is proposing to restrict coverage guidelines and reimbursement for Vitamin D testing to Medicare patients. With another hand, the federally-funded National Institutes of Health (NIH) is funding a large, multi-year study to assess the effect Vitamin D supplements and fish oil have in reducing health risks!
Researchers at Harvard Medical School will investigate whether taking daily dietary supplements of Vitamin D or fish oil reduces the risk of developing cancer, heart disease, and stroke in people with no previous history of such illness. Under a $20 million grant from the National Institutes of Health Institutes, researchers from Harvard Medical School and the Brigham and Women’s Hospital in Boston, Massachusetts, will recruit 20,000 participants for the study nationwide. (more…)
One Medicare contractor is proposing a new policy that would effectively end payment to labs and physicians for routine testing for Vitamin D deficiency. In its proposed local coverage determination (LCD), the Medicare carrier indicates that it would cover Vitamin D testing only for patients with chronic kidney disease, osteomalacia, hypercalcemia, and rickets. The LCD states that other testing for Vitamin D would be denied.
The draft (or proposed) LCD is dated February 6 and was posted on the Web site of National Government Services (NGS), one of the nation’s largest Medicare contractors. Medicare has asked for comments through February 21. If accepted as proposed, the denials for routine Vitamin D testing would begin on June 1, according to the LCD. In the posted draft, Medicare added a disclaimer saying that LCDs are not necessarily a reflection of the current policies or practices.
National Government Services (NGS) serves 200,000 providers and suppliers, along with nearly 24.5 million Medicare beneficiaries in 25 states and five U.S. territories. Not all Medicare providers will be affected by the LCD that NGS posted. Other Medicare carriers may have posted a similar LCD.
The draft of the NGS LCD says, “Measurement of vitamin D levels is indicated for patients with chronic kidney disease, osteomalacia, hypercalcemia, and rickets. Measurement of vitamin D levels is not indicated for screening. Measurement of any other Vitamin D metabolites (CPT codes 82307 & 82652) is not indicated, and will be denied.”
The draft LCD further states, “An excess of Vitamin D is unusual, but may lead to hypercalcemia. Vitamin D deficiency may lead to a variety of disorders, the most infamous of which is rickets. 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.”
The Vitamin D Council, a nonprofit organization in Atascadero, California, reported the news on February 13. “If this rule passes, the change will quickly extend to all Medicare districts,” predicted the newsletter. “Private insurers will then follow suit, denying payment for Vitamin D blood tests, even for the diagnoses of Vitamin D deficiency. This rule change flies in the face of an enormous amount of research, some of it published in the last few months. For example, several weeks ago, the British Journal of Cancer reported that in men with prostate cancer, those with highest Vitamin D blood levels were seven times more likely to survive than were men with the lowest levels.”
It may be that Medicare officials are reacting to the significant increase in the volume of Vitamin D testing seen during the past two years. Much of this increased test volume is a result of ongoing media coverage about the importance of Vitamin D and new stories encouraging people to visit their doctors and request that their Vitamin D levels be checked.
For the laboratory industry, this is not an auspicious development. In the past, Medicare has used restrictions on coverage as a way to constrain utilization of certain procedures, thus helping it to control costs. Some lab industry experts are already speculating that this may be the reason why, at this time, one of Medicare’s largest carriers has published a proposed LCD that would limit reimbursement for Vitamin D testing only to a limited number of clinical situations. The Dark Report and Dark Daily will follow this developing story closely in the coming weeks