Because the Centers for Medicare & Medicaid Services (CMS) does not believe that current available evidence demonstrates that pharmacogenomic testing to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries, the agency stated in a proposed decision memo that it would not provide coverage for Medicare beneficiaries for this testing. However, CMS said the available evidence on the effectiveness of the pharmacogenomic testing suggested that coverage with evidence development (CED) would be appropriate. Therefore, this testing would only be covered if the beneficiary were a candidate for anticoagulation therapy with the drug warfarin in the context of a randomized clinical trial that meets specific criteria.

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June 2009 - Table of Contents

LIR June 2009 (full PDF issue)

G-2 Reports March Survey Finds Test Volume Growth Slows to Less Than 1% During First Quarter; Lab Directors Expect 1.4% Growth for 2009

H1N1 Pandemic Threat, Health Care Overhaul Underscore Key National Priorities for Labs

CAP, ASCP Join ACLU Suit Over Breast Cancer Gene Patents

CMS Denies Reimbursement for Gene-Based Warfarin Testing; Proposes Clinical Trial Coverage

Medicare Part B Lab Spending Up 3.3% to $7.3 Billion in 2008

Inside the Lab Industry: CDC Limits Lab Industry’s Role in H1N1 Flu Diagnosis Due to IP, Reagent Supply Concerns

PLUS Diagnostics Opens West Coast Lab; Plans to Launch Hematology/Oncology Testing Services This Year

Rosetta Genomics Sells Parkway Clinical Labs for $2.5 Million in Management Buy-Out

Lab Stocks Continue to Gather Strength; Up 3% Over Five Weeks, 10% for 2009

Industry Buzz: OIG Finds Improper Medicaid Spending on Lab Services