News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Palmetto GBA Execs Explain MolDx, Its New “Molecular Diagnostic Services” Program for Clinical Pathology Laboratories

Registry for genetic tests and molecular diagnostic assays is one step in process to assess the science and clinical utility

Clinical laboratory and pathologists have dozens of questions about the proposed draft local coverage determinations (LCDs) that Medicare carrier Palmetto GBA issued on September 28. The draft LCDs represent Palmetto GBA’s efforts to identify the growing number of laboratory-developed molecular diagnostic assays and genetic tests.

In an exclusive interview with Dark Daily, Palmetto Medical Director Elaine Jeter, M.D., and Palmetto Vice President Mike Barlow explained the need for the new LCDs and offered insight into the process Palmetto GBA is developing to create a molecular test registry and a coverage determination and reimbursement process. This is an important development for the clinical laboratory industry. (more…)

Palmetto, Medicare’s Biggest Carrier, Proposes to End Code Stacking for Molecular Clinical Laboratory Tests

Palmetto wants to implement two proposed local coverage determinations (LCDs) on February 27, 2012

Medicare’s biggest local carrier is ready to tackle the problems created when clinical pathology laboratories use code stacks to submit claims for genetic tests  and molecular diagnostics assays. Medical laboratories in eight states served by this Medicare carrier are worried about its two draft proposals that could cut off reimbursement for large numbers of molecular diagnostic tests (MDTs) and laboratory-developed tests (LDTs), starting February 27, 2012.

The Medicare carrier is Palmetto GBA, of Columbia, South Carolina. On September 23, it shook up the clinical laboratory industry and pathology profession nationwide when it announced, in a “draft proposal” for a local coverage determination (LCD), that it would not allow labs to submit claims for most MDTs. As noted above, the proposed effective date is February 27, 2012.

Medicare Considers Denying Payment for Routine Vitamin D Testing

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

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