HERE'S AN INTERESTING QUESTION: Are labs to be punished because patients want to know if their Vitamin D levels are sufficient? Consider this: THE DARK REPORT predicted last year that labs might suffer a backlash from payers as a result of increased demand for Vitamin D testing.

In a briefing titled: "Vitamin D Test Volumes Double in Past Year," published on July 28, 2008, we said, "Across the nation, labs report a near doubling in the volume of Vitamin D tests they are performing. Will Medicare and private payers recognize that, per evidence-basedmedicine guidelines, this testing is justified and labs should not be punished for increased utilization?"

Now comes news that National Government Services (NGS), one of the nation's largest Medicare contractors, is taking steps to make that prediction become reality by its proposal to stop paying for routine testing for Vitamin D insufficiency. In its proposed local coverage determination (LCD), NGS said it would cover Vitamin D testing only for patients with chronic kidney disease, osteomalacia, hypercalcemia, and rickets. Other testing for Vitamin D would be denied. Is this short-sighted bureaucratic thinking? Or is it part of a shrewd, long-term strategy to reshape utilization of laboratory testing in this country? (See pages 7-8)

After all, if Medicare patients must pay out of pocket for Vitamin D testing, then many will forego these tests, putting themselves at risk for longterm chronic conditions. Eventually, Medicare will need to pay to treat patients who have these chronic and costly conditions. For that reason, NGS' proposal to deny coverage for routine Vitamin D sufficiency testing puts Medicare squarely at odds with its stated goal of supporting early detection and preventive medicine. So much for a $40 Vitamin D test once every year or two and its potential to save the healthcare system tens of thousands of dollars per patient in downstream costs.

More importantly for the laboratory industry, this ill-conceived proposal to deny coverage for a test that is relatively non-controversial should be viewed for what it is: less an effort to guide clinicians via appropriately coverage guidelines and more a deliberate step to constrain increases in the cost of care by shifting the burden away from Medicare and onto both patients and the laboratories that provide their physicians with these tests.

Molecular Advances Soon To Reshape Anatomic Path

Predictions that pathology is to become more quantitative because of new technologies

CEO SUMMARY: Early this month, the second annual Molecular Summit assembled molecular first movers and early adopters to discuss their efforts to integrate molecular imaging and molecular diagnostics in patient care. One clear message emerged from two days of presentations and discussion: a host of new technologies is ready for clinical introduction and is likely to rapidly transform both radiology and pathology.

Medicare Carrier Proposes No Pay for Vitamin D Test

Proposal restricts coverage for Vitamin D tests to four diseases and no allowance for screening

CEO SUMMARY: Medicare contractor NGS wants to end payment to labs and physicians for routine Vitamin D testing. In a proposed local coverage determination (LCD), the Medicare carrier says it would cover Vitamin D testing only for patients with chronic kidney disease, osteomalacia, hypercalcemia, and rickets. All other testing for Vitamin D would be denied. Endocrinologists responded by labeling the NGS proposal as "flawed and incomplete, a factor that would shortchange current medical practice."

Ten Years Ago: Quest Diagnostics Agrees to Buy SmithKline Labs

Strategic move in 1999 put Quest at the top of the lab services marketplace in the United States

Local Labs Have Opportunities To Increase MC Patient Access

Managed Care Pricing Trends and New Strategies

CEO SUMMARY: Although the nation's two largest laboratory companies have achieved a dominant managed care position, opportunities remain for regional labs to do more business with managed care plans. Two experts provide an update of managed care pricing trends for laboratory testing services. For independent labs and hospital lab outreach programs seeking to expand access to managed care patients, they also offer several simple, but effective, simple business strategies.

Need Rigorous Validation For Home Brew Assays

Challenge is for laboratory to verify accuracy, then report results that clinicians easily understand

CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. One, accuracy, reproducibility, and transferability of the test result number. Two, a reference range that is easily-understood by clinicians and consistent with published studies and existing lab test methodologies.

INTELLIGENCE: Late & Latent

FLU ANTIBODIES PROMISE UNIVERSAL PROTECTION

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