The College of American Pathologists has waded into the immunohistochemical staining issue, asking Medicare fiscal intermediary Palmetto GBA to drop its draft local coverage determination (LCD) for regulating the practice. The request comes after CAP had all but asked for an LCD in lieu of an educational letter Palmetto had posted on its website last year regarding staining guidelines for some gastric cases. Palmetto withdrew the letter after CAP said it was acting in an arbitrary manner. The lobbying organization also filed a letter of complaint with Centers for Medicare & Medicaid Services Director Marilyn Tavenner on the matter. Palmetto had decided to scrutinize special and immunohistochemistry staining practices because some pathologists had been ordering as many as a dozen such stains for a single gastric case, suggesting the process was being abused. Medicare pays between $12.12 to $97.67 per stain, depending on the region of the country the work is being performed in and other circumstances. Although lengthy, Palmetto’s draft LCD is quite specific about when staining should be used and not used. In its draft LCD, which covers not only staining for gastric but breast, lung, gynecologic, skin, and soft tissue samples, among others, Palmetto suggested that stains […]
The College of American Pathologists has waded into the immunohistochemical staining issue, asking Medicare fiscal intermediary Palmetto GBA to drop its draft local coverage determination (LCD) for regulating the practice.
The request comes after CAP had all but asked for an LCD in lieu of an educational letter Palmetto had posted on its website last year regarding staining guidelines for some gastric cases. Palmetto withdrew the letter after CAP said it was acting in an arbitrary manner. The lobbying organization also filed a letter of complaint with Centers for Medicare & Medicaid Services Director Marilyn Tavenner on the matter.
Palmetto had decided to scrutinize special and immunohistochemistry staining practices because some pathologists had been ordering as many as a dozen such stains for a single gastric case, suggesting the process was being abused. Medicare pays between $12.12 to $97.67 per stain, depending on the region of the country the work is being performed in and other circumstances.
Although lengthy, Palmetto's draft LCD is quite specific about when staining should be used and not used. In its draft LCD, which covers not only staining for gastric but breast, lung, gynecologic, skin, and soft tissue samples, among others, Palmetto suggested that stains for many breast and lung cancer cases are not necessary, and that special gastric stains can be performed only when medical necessity is established in the patient records (about 20 percent of the time, Palmetto concluded).
Nevertheless, a Christmas Eve letter from CAP President Gene Herbek, M.D. to Palmetto Medical Director Elaine Jeter, M.D., asked that the organization hold off on its LCD. The correspondence was part of the 45-day public comment period that began in November and ended on Christmas Day.
"The (draft) LCD uses highly selective and partial literature citation, takes references out of context, overlooks fine points, misrepresents the opinions of national organizations, and is contrary to generally accepted guidelines," Herbek wrote. CAP's specific comment on the entire LCD suggested that Palmetto did not even substantiate overutilization.
Moreover, CAP claimed there was a lack of clinical consensus in some of its conclusions, such as the 20 percent threshold for gastric staining. "This utilization threshold is arbitrary and not supported by evidence or consensus of the pathology community," Herbek wrote, adding that Palmetto appeared to make its conclusion based on a single 2006 study.
As a result, the LCD would interfere with a pathologist's ability to make conclusions on staining based on medical necessity alone, CAP argued.
Palmetto is expected to analyze the public comments on its draft LCD and issue revisions later this year.
Takeaway: The College of American Pathologists is continuing to exert pressure regarding the outcome of how special stains are regulated and paid for.
