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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CMS to Conduct Public Meeting on Genetic and Molecular Laboratory Test Billing

Medicare officials seeking public comment during the July 18 meeting

Changes in how the Medicare program will reimburse pathology groups and clinical laboratories for genetic tests and molecular diagnostic assays will be one of the important topics at an upcoming meeting in Baltimore on July 18, 2011. The federal Centers for Medicare and Medicaid Services (CMS) will conduct the meeting at its headquarters and is asking for public comment as it develops coverage guidelines and reimbursement levels for the 2012 laboratory test fee schedule.

As many pathologists and medical laboratory managers know, a major effort to revise and update CPT codes for genetic and molecular tests performed by clinical laboratories is moving forward. The goal is to recognize advances in this field of diagnostic testing by updating the CPT codes. Another goal, widely supported by private health insurance plans, is to reduce the use of “code stacking” as the primary coding and claims methodology that must be used for a large number of genetic and molecular medical laboratory tests.

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Good News for Clinical Pathology Laboratories: Medicare Officials Intend to Rescind Rule Requiring Physician Signatures on Paper Lab Reqs


CMS says it will take steps to rescind the final rule before its scheduled implementation on April 1, 2011

Clinical laboratories and pathology groups will welcome the news that the federal Centers for Medicare & Medicaid Services (CMS) will take steps to rescind the final rule that requires the physician’s signature be on all paper requisitions for medical laboratory tests ordered on behalf of Medicare patients. It means that implementation of the rule—now scheduled to become effective on April 1, 2011—will not happen if CMS officials act in a timely manner.

Dark Daily has learned that last Friday a conference call took place involving Jonathan Blum, Director of the Center for Medicare Management, and representatives from the American Association of Bioanalysts (AAB) and the American Clinical Laboratory Association (ACLA). During the conference call, Blum disclosed that a decision had been reached within CMS to rescind the final rule that would require physicians’ signatures on paper requisitions for medical laboratory tests. Apparently, CMS intends to take the steps necessary to rescind this final rule before its effective date of April 1, 2011.
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Medicare and Medicaid Under-Reimbursement Continues to Drive Healthcare Providers Out of the Programs

No clinical pathology laboratories are known to have ceased serving Medicare and Medicaid patients


It’s widely acknowledged by physicians and other providers that Medicaid reimbursement in many states is significantly less than the true cost of providing the service. There are also many types of health procedures where Medicare reimbursement fails to fully reimburse the provider. Thus, it is an important signal when two prominent healthcare organizations announce that—in certain locations and for certain services—they will no longer serve Medicaid or Medicare patients.

Pathologists and clinical laboratory managers will soon see an increasing number of healthcare providers decide to cease serving Medicare and/or Medicare patients. Just in the past 12 months, such nationally respected healthcare organizations as Walgreens and Mayo Clinic have announced that, in certain markets, they will no longer serve new Medicare and/or Medicaid patients. The details of these decisions are revealing.

In the State of Washington, earlier this spring, Walgreens (NYSE:WAG) announced that all 121 of its pharmacies in the state would no longer accept new Medicaid patients. This followed an earlier announcement by the Bartell Drugs chain that its 44-store chain would also no longer serve new Medicaid patients in Washington State.

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New Genetic Laboratory Tests Face Complicated Hurdles to Win Reimbursement

Health insurers not eager to establish coverage for new molecular diagnostic assays


Navigating the pathway to successful commercialization of new genetic tests and molecular diagnostic assays has proven tricky. While scientists work quickly to bring new and better clinical laboratory testing tools to the market, health insurers work at a much slower pace to issue coverage guidelines and establish reimbursement for these new diagnostics tests.

“Successfully moving a genetic test from the research bench to the clinical laboratory takes much more than an understanding of the science,” stated Rina Wolf, Vice President of Commercialization Strategies for Consulting and Industry Affairs, XIFIN Inc., of San Diego, California. “Competition for coverage and reimbursement by health insurers is fierce. Often, the molecular diagnostic tests that win the best coverage decisions by payers are those proprietary tests backed by companies and laboratories with the most effective business plans.”

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Regional Laboratory Consolidation and Shrinking Budgets Are Key Issues for Clinical Pathology Labs in the United Kingdom

Focus Conference in Glasgow puts spotlight on how medical laboratories must deliver more testing with less reimbursement


Clinical pathology laboratory services might be considered “under siege” in the United Kingdom. That’s because clinical laboratories are facing significant reductions to their annual budgets, even as health trusts throughout the country push for regional integration and further consolidation of laboratory testing services.

This week in Glasgow, Scotland, the Association for Clinical Biochemistry is conducting Focus, its annual meeting. This large gathering for the laboratory medicine profession in the United Kingdom offers attendees a wide spectrum of topics and speakers relating to laboratory testing. Your Dark Daily Editor is here to chair a session, learn from the many interesting presentations, and visit some hospital laboratories in Glasgow.

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