Although the pricing on 114 molecular codes the Centers for Medicare and Medicaid Services (CMS) released last week are interim, fears are mounting in the lab sector they’re precipitating a crisis that will be permanent.Pathology and lab observers all said the same thing about the new pricing: The rates released by CMS are too low to cover the costs of performing the tests and represent a disaster in the making since the agency announced late last year it was placing new molecular pathology (MoPath) codes on the clinical laboratory fee schedule and leaving it up to regional Medicare administrative contractors (MACs) to determine prices. The interim prices range from $41.41 in some regions for the Factor V Leiden test, CPT Code 81240, to determine a genetic tendency for deep vein thrombosis, to $8,792.88 for genetic testing for congenital long QT, CPT Code 81282. For some labs, the lower prices for many codes means they will have to stop performing certain tests. Labs that focus heavily on molecular testing may see their very survival jeopardized as a result of the low prices. A group of nine trade organizations related to the laboratory sector—including the College of American Pathologists (CAP), the American Clinical Laboratory Association, and the California Clinical Laboratory Association (CCLA)—last week asked CMS to hold off on finalizing the prices as planned in September after a 60-day public comment period that commenced last week as well. It also asked the agency to hold open-forum sessions to address the lab sector’s questions and concerns. “The whole process has gone awry. It’s really quite difficult at this point,” said Michael Arnold, executive director of the CCLA. The CCLA has been instrumental in lobbying Palmetto GBA, the regional MAC for California, to raise the prices on some tests. Palmetto was among the first contractors to announce its initial MoPath pricing, and many other contractors have used those rates as a basis for setting their prices. Palmetto agreed last month to adjust pricing for eight higher-volume tests, raising them a nonweighted average of 75 percent. However, the increases did not cover another 106 tests. And the rationale accompanying CMS’s decisionmaking process noted that the MACs were permitted to collaborate with one another on their pricing and that several became reliant on Palmetto’s lead. Early Stages Jonathan Myles, M.D., chairman of the CAP economic committee, preferred to take more of a long view. “We are in the early stages of the gap-fill process,” he said. “It is important that the various stakeholders and payers realize this is not final.” But Myles, who serves as the CAP’s liaison to the American Medical Association’s committee that helps set pricing for medical procedures, said the actual cost data for performing the tests has not been closely scrutinized by the MACs or CMS. “If they converted that into real dollars, they would be significantly greater than the posted prices,” he said. Myles added that the comment period is likely to encourage some upward adjustments on the prices. However, he noted that the process for the price setting has not been appropriately open to all the parties—a concern shared by others. “We have to yet to see any real rationale or transparency to the gap-fill process,” said Rina Wolf, vice president of commercialization strategies, consulting, and industry affairs for XIFIN, a San Diego-based revenue cycle management firm. Wolf has been actively tracking developments in pricing of molecular pathology tests.