CEO SUMMARY: Across the nation, labs report a near doubling in the volume of vitamin D tests they are performing. This is a success for laboratory medicine and an appropriate use of diagnostics tests as physicians strive for early detection and early intervention of vitamin D deficiency. However, the next chapter in this story will be equally important. Will Medicare and private payers recognize that, per evidence-based medicine guidelines, this testing is justified and labs should not be punished for increased utilization?
CLINICAL LABS ACROSS THE COUNTRY are doing about twice as many tests for vitamin D deficiency this year as they did last year. This increase is due to the concerns of both patients and physicians that aging Americans are not getting sufficient levels of vitamin D, thus causing a deficiency that can lead to ill effects, such as bone loss, cancer, and diabetes.
To find out more about the increased utilization of vitamin D testing, THE DARK REPORT contacted A. Wayne Meikle, M.D., Medical Director of the Endocrinology and Automated Endocrinology Laboratory at ARUP Laboratories, a national reference lab in Salt Lake City, Utah. Meikle also is a Professor of Medicine, Endocrinology, and Pathology at the University of Utah School of Medicine.
“For the past year, ARUP’s database shows that our laboratory has seen an increase of more than 100% in the number of tests we performed for vitamin D deficiency,” reported Meikle. “Last year, we averaged about 40,500 vitamin D deficiency tests per month. This year, that has increased to an average of about 82,000 tests per month.
“I believe the increase is a result of a combination of physicians recommending the test to their patients and patients asking their physicians for this test,” added Meikle. “There has been extensive press about the health issues related to vitamin D deficiency, and much of the media coverage has included education on the value of maintaining vitamin D levels. At the same time, physician awareness has increased as they realize how common vitamin D deficiency is among their patients.”
Earlier this month, USA Today published an article about heightened awareness of vitamin D deficiency. It included lab testing data. It noted that Quest Diagnostics Incorporated of Madison, New Jersey, reported that tests for vitamin D grew by about 80% from May 2007 to May 2008. Laboratory Corporation of America, in Burlington, North Carolina, acknowledged a 90% increase in tests for vitamin D levels from 2007 to 2008. Neither company would release the actual numbers.
USA Today also reported that the Mayo Clinic, in Rochester, Minnesota, processed 424,582 tests for vitamin D deficiency last year, which represented an increase of 74% over the number of such tests it ran in 2006. Mayo expects to run more than 500,000 such tests this year.
Test Volume Has Tripled
It’s a similar story at Kaiser Permanente. “The volume of vitamin D tests has skyrocketed!” declared Thomas S. Lorey, M.D., Director of the Regional Laboratory for Kaiser Permanente Northern California, which provides testing for approximately three million beneficiaries. “Our volumes have tripled in the last year, and we don’t feel that we have yet reached a plateau.”
This stunning and rapid increase in the utilization of Vitamin D testing by patients and physicians—unrecognized by the broader laboratory industry until this DARK REPORT intelligence briefing—is likely to be a landmark development. It demonstrates new implications from fast- moving reforms to the American healthcare system.
First, this shows how quickly newly-issued evidence-based medicine (EBM) guidelines can change clinical practices—and dramatically alter long-standing laboratory medicine experience and test-ordering patterns. With little warning, the laboratories referenced above have seen a near-doubling of vitamin D tests in just 12 months!
Second, Meikle specifically mentioned the public’s rapid acceptance of the need for vitamin D deficiency testing. It shows that informed consumers are taking an active role in their care and requesting that their physicians order these tests.
That raises an interesting question. Since, historically, clinicians in this country have been famously slow to incorporate new clinical knowledge into their daily practice, is this doubling of vitamin D testing in less than a year a demonstration of new-found consumer power in healthcare? If this is true, it is a powerful signal to laboratory administrators and pathologists. Over time, their laboratory organizations may be in peril if they fail to address the changing role of the consumer in healthcare.
Third, the payer response to this development has yet to be seen. There is every reason to believe this testing is being performed in appropriate situations. Thus, laboratories should not be financially- penalized because utilization of vitamin D testing has doubled and the payer’s lab spend has increased proportionally.
The laboratory industry, and its lobbying groups, should not allow the payer community to double-deal as it has in the past. Often, payers, including Medicare, publicly claim support for evidence-based guidelines, and, as in the case of increased vitamin D testing, affirm it is the right and proper way to achieve early diagnosis and early intervention because it improves downstream patient outcomes and lowers the long-term cost of care.
Payers Try To Cut Lab Costs
Yet, these same payers, quietly out of the public eye, when it comes time to negotiate fees with laboratories, complain that test utilization has gone up and the laboratory’s job is to control that utilization. As a consequence, payers often force laboratories to accept less reimbursement because of the increased test utilization.
For these reasons, this episode of increased vitamin D testing will teach lab administrators and pathologists some useful lessons about how to respond, in the future, when a new evidence-based medicine guideline triggers a substantial increase in laboratory testing in support of the EBM. At a minimum, this sudden rush of vitamin D testing tells us that changes are definitely afoot in the U.S. healthcare system.
Labs Have Opportunity to Help Physicians By Providing Vitamin D Testing Pathways
VITAMIN D TESTING IS AN OPPORTUNITY for local laboratories. “To support physicians, use of diagnostics pathways would help clinical labs explain the issues involved in vitamin D testing,” explained A. Wayne Meikle, M.D., Medical Director of the Endocrinology and Automated Endocrinology Laboratory at ARUP Laboratories. “Here at ARUP, we do two tests. One is called vitamin D 25 and one is called vitamin D, 1, 25. We have seen an increase in both tests, but mostly the increase has come in volume for the vitamin D 25 test, as it should be.
“Because some physicians may be unaware of which test they should order, they will order both,” Meikle said. “Often when an order comes in for vitamin D 1, 25 to diagnose vitamin D deficiency, usually what the physicians should order is the vitamin D 25 test instead. That’s why use of pathways would be appropriate.
Choosing The Right Test
“With vitamin D deficiency, the patient’s parathyroid hormone level goes up, which can leach calcium out of bone and contribute to the development of osteoporosis,” Meikle explained. “When the parathyroid hormone level goes up, the vitamin D 1, 25 level may be quite normal. That’s why the vitamin D 25 test should be used when testing for a deficiency.
“Another problem with diagnosing vitamin D deficiency is our routine chemistry tests don’t give us a clue that an individual may be deficient,” he added. “The calcium level may be perfectly normal, leading the referring physician to think everything is fine. That’s why a referring physician needs to be specific in measuring vitamin D 25 to confirm the deficiency.
“In fact, I analyzed our database to see how many individuals among all of our patients are deficient,” said Meikle. ”About 30% of the individuals we have tested have a vitamin D deficiency. That’s quite a high percentage.
“A number of factors can contribute to low levels of vitamin D and many people are not aware of these factors,” he continued. “As an endocrinologist, I see these people clinically and it’s clear that one factor that contributes to vitamin D deficiency is that, as people age, their skin is less efficient at making vitamin D from sunlight or ultraviolet light. Another factor is people, as they age, tend to drink less milk and so their intake of calcium is reduced. For these two reasons, older Americans are set up for a vitamin D deficiency, and, as we know, we have an aging population.
“Another reason that many patients may not make enough vitamin D is their concern about being overexposed to sunlight. Use of sunscreen effectively blocks the benefit we get from the sun,” Meikle said. “So, we have a choice: Do we want to risk skin cancer or use sunscreen and have a vitamin D deficiency?
“In addition to these concerns, many patients do not normally get enough vitamin D in the diet or with supplements,” Meikle said. “For all of these reasons, it is certainly appropriate for referring physicians to screen patients who are over age 50 for a vitamin D deficiency.
“The recommendations for how much vitamin D an individual should get has steadily gone up among physicians who have studied vitamin D and its metabolite consequences,” he added. “A few years ago, for a person over age 60, these physicians recommended supplementing the diet with 600 units of vitamin D each day. Now, they want the total intake to be 1,200 units for a person over 60 years or older.”