Palmetto Backtracks on Gastric Staining Guidelines
The College of American Pathologists (CAP) and the Centers for Medicare and Medicaid Services (CMS) have chimed in on the great gastric staining debate—and Medicare administrative contractor Palmetto GBA has blinked. Palmetto recently removed from its Web site an education article stating that pathologists should refrain from using special stains for some gastrointestinal (GI) diagnoses […]
The College of American Pathologists (CAP) and the Centers for Medicare and Medicaid Services (CMS) have chimed in on the great gastric staining debate—and Medicare administrative contractor Palmetto GBA has blinked. Palmetto recently removed from its Web site an education article stating that pathologists should refrain from using special stains for some gastrointestinal (GI) diagnoses a large majority of the time or potentially face action from Palmetto. “We removed it under consideration that a better approach for this and other [immunohistochemical] utilization issues may be to consider publishing a [local coverage determination] but that next step is under review at this time,” Palmetto Vice President of Operations Mike Barlow said in an e-mail. Palmetto was recently contacted by CMS regarding the matter, according to correspondence between the agency and CAP. CAP sent a formal letter of complaint in late June to the CMS regarding Palmetto’s issuance of new guidelines regarding the use of immunohistochemical stains for some gastric patients. It claimed the guidelines were arbitrary and did not take into consideration the individual circumstances involving each case. Palmetto, which called the advisory it issued last spring an “education article,” directly discouraged the use of ancillary special stains such as alcian blue and periodic acid schiff for stomach biopsies, noting that “there is potential for either overutilization or under-utilization of these ancillary special stains” for both intestinal metaplasia and H. pylori. Palmetto concluded that the use of such stains is justifiable in 20 percent or fewer GI cases and that it might take action against pathologists who exceed that threshold. Medicare is billed for such stains at the rate of $12.12 to $97.67 apiece. While some pathologists may order two or three such stains, some industry observers say it is not unheard-of for some to order a dozen or more of the stains—a likely sign of abuse. But CAP, in a five-page letter sent to CMS Administrator Marilyn Tavenner on June 25, asserted that Palmetto was acting in an arbitrary manner. “CAP believes that Palmetto has overreached its authority by imposing an arbitrary numerical utilization threshold on providers utilizing special stains in gastric biopsies and then threatening to use unspecified enforcement actions against providers,” said the letter, which was under the signature of Jonathan L. Myles, M.D., who chairs CAP’s economic affairs committee. The letter urged CMS to have Palmetto remove the article from its Web site or modify it significantly, noting that the letter cannot be educational if it includes threats of further actions. “Providers can only assume that Palmetto’s threat of ‘additional action’ against providers who exceed its arbitrary utilization threshold is a reference to the use of some component of the government’s broad arsenal of compliance and fraud and abuse investigative and enforcement mechanisms.” The letter also stated that if Palmetto wants a blanket policy regarding gastric stains, it can resort to the local coverage determination process—which includes feedback from providers—in order to do so. In a letter Tavenner sent to Myles sent in late July, she said that Palmetto was contacted and it decided to remove the educational article. Palmetto told Laboratory Industry Report back in June that it detected overutilization of special gastric staining and that it took the appropriate action to rein it in. At the same time, it also issued an educational letter discouraging the use of Ki-67, PI3K, and gene expression assays for breast cancer diagnoses. That letter remains on Palmetto’s Web site. Takeaway: Pushback from the College of American Pathologists appears to have caused Palmetto GBA to yield on the GI special stains utilization issue.