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       Headlines - November 28, 2011
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R. Lewis Dark: Molecular Code Stacks Now in the Payers' Bull's Eye

LIKE A STEAM BOILER READY TO EXPLODE FROM TOO MUCH PRESSURE, the nation's health insurers have reached a point of no return on the subject of codestacked claims for genetic testing and molecular diagnostics assays. Simply put, payers are ready to tackle this sensitive issue.

Payers have reasonable questions about this type of clinical lab testing. Is it sound practice to accept a claim for a laboratory test that does not identify the clinical function of the diagnostic test? Equally relevant, why would labs expect any payer to reimburse a laboratory test claimthat didn’t include information necessary to identify that the molecular lab test is an appropriate clinical procedure for the patient, given the specific health conditions the attending physician is investigating?

Code stacking claims for genetic tests and molecular assays generally fail to give payers useful information on both of these points. If this were your company, and you were paying the bills, would you consider it good business to accept these claims without challenge and issue payment? Wouldn't you want to understand the clinical purpose and the clinical efficacy of these genetic and molecular tests?

How did health insurers and the clinical lab testing industry get to this point? The process of creating new CPT codes probably has a role in this story. After all, we are more than a decade into the genetic testing era and the CPT coding system is woefully behind today's molecular testing marketplace. Most pathologists have heard the comment attributed to Otto von Bismarck, a German politician of the 19th Century, who said: "If you like laws and sausages, you should never watch either one being made." Some have hinted that the process and politics of updating the CPT coding system would probably fit Bismarck's description of law- and sausage-making.

The fact remains that current CPT codes do not help labs describe all the tests they perform in support of clinical care. Nor do health insurers get the precise information they need when code-stacked claims for molecular tests are submitted for reimbursement. It is no surprise, then, that, as of March 1, 2012, one important Medicare carrier is stepping up with a plan to provide an interimsolution to the recognized inadequacies of existing CPT codes for genetic andmolecular tests. It may not be perfect, and it is likely to be criticized and even challenged in court. But it is the shoe that everyone has been waiting to drop. And now it appears that it will.


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Palmetto Execs Explain Molecular Test Policies

Goal is to create a process to assess science and clinical value for molecular tests and LDTs

CEO SUMMARY: To create more transparency in the process clinical labs use to submit claims for genetic tests, molecular diagnostic tests, and for laboratory-developed tests LDT), the nation’s largest Medicare Administrative Contractor MAC) has proposed two new local coverage determinations LCD). CMS has changed Palmetto GBA's statement of work to include implementing a lab test registry and science review process for genetic,molecular, and laboratory-developed tests.



Palmetto GBA Announces Molecular Test Registry

Laboratories in California, Hawaii, and Nevada need to seek approval for each code-stacked test

CEO SUMMARY: Palmetto GBA, the nation's largest Medicare Administrative Contractor (MAC), is asking labs in the J1 jurisdiction to submit applications for each molecular test they run. Molecular assays will receive a unique five-digit alpha-numeric identifier (Z-code) that will be entered into the narrative/comment field on claims. A panel of subject matter experts will evaluate the analytical and clinical validity of the assays, and to determine the clinical utility of the assay.



Rite Aid Offers Free Tests To Preferred Customers

National chain has pharmacists discuss lab test results with rewards program members

CEO SUMMARY: National pharmacy chain Rite Aid now offers free clinical laboratory tests to members of its customer-rewards program once they reach certain spending levels. After the customer's specimen is tested, the laboratory test results are sent directly to the customer’s local Rite Aid pharmacist. Next, the pharmacist will discuss the lab test results with the consumer. This marketing program is the latest example of how pharmacies want to use lab testing as a way to generate more prescriptions.



Book Review: New Lab Management Resource For Pathologists, Lab Leaders

"Laboratory Administration for Pathologists" offers comprehensive and up-to-date information



Anatomic Path Insourcing Expected to Be Ongoing

Pathologists and lab executives surveyed affirm their belief that this trend will continue

CEO SUMMARY: Insourcing of anatomic pathology services by office-based physicians has been especially prevalent and is increasing among three specialties (gastroenterology, urology, and dermatology), according to a survey conducted last month. Survey respondents also indicated that the trend toward increased insourcing is so strong that it could spread to other specialty groups such as ob-gyns and oncologists. THE DARK REPORT and Blair & Company conducted the survey in October.



INTELLIGENCE: Late & Latent

MORE ON: Telemedicine

TRANSITIONS: On December 1, Joseph Skrisson will become the Chief Operating Officer at Dynacare Laboratories, Inc.






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