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Palmetto Institutes New LCD Regarding Biopsy Stains

by | Feb 26, 2015 | Essential, Laboratory Industry Report

After a contentious process regarding the staining practices and clinical freedoms that should be granted pathologists, the Medicare fiscal intermediary Palmetto GBA has apparently initiated new local coverage determination guidelines. Palmetto submitted the guidelines to the Centers for Medicare & Medicaid Services on Jan. 29. They appear mostly unchanged from draft guidelines it had proposed last year, with few revisions. The guidelines had drawn fire from the College of American Pathologists, which had asked in December that they be withdrawn completely, suggesting that the medical literature on which they were based was inconsistent. Palmetto had decided to scrutinize the issue last year, after some pathologists were billing for as many as a dozen stains for a single gastric case, with Medicare paying anywhere from $12.12 to $97.67 for each stain. Its new LCD also includes guidelines for breast, lung, gynecologic, kidney, skin, and soft tissue samples. The LCD is altered little from Palmetto’s original draft. Some leeway had been granted for pre-ordering ancillary stains for liver, kidney and some muscle biopsies, and if a patient has immunity issues that could lead to severe medical problems if the biopsy analysis is delayed. And analysis of Ki-67 for breast tissue biopsies will […]

After a contentious process regarding the staining practices and clinical freedoms that should be granted pathologists, the Medicare fiscal intermediary Palmetto GBA has apparently initiated new local coverage determination guidelines. Palmetto submitted the guidelines to the Centers for Medicare & Medicaid Services on Jan. 29. They appear mostly unchanged from draft guidelines it had proposed last year, with few revisions. The guidelines had drawn fire from the College of American Pathologists, which had asked in December that they be withdrawn completely, suggesting that the medical literature on which they were based was inconsistent. Palmetto had decided to scrutinize the issue last year, after some pathologists were billing for as many as a dozen stains for a single gastric case, with Medicare paying anywhere from $12.12 to $97.67 for each stain. Its new LCD also includes guidelines for breast, lung, gynecologic, kidney, skin, and soft tissue samples. The LCD is altered little from Palmetto’s original draft. Some leeway had been granted for pre-ordering ancillary stains for liver, kidney and some muscle biopsies, and if a patient has immunity issues that could lead to severe medical problems if the biopsy analysis is delayed. And analysis of Ki-67 for breast tissue biopsies will no longer be covered. “The CAP continues to vigorously oppose the LCD because the purported supporting evidence is weak and appears to be comprised of citations selected to confirm a predetermined position,” said George F. Kwass, M.D., chair of CAP’s council on government and professional affairs. “Further, the LCD encroaches on pathologist’s medical judgment by undercutting the core values of pathologists as physicians, consequently limiting beneficiary access to care, and fails to take into account patient populations that vary from practice to practice. The CAP will continue to advocate that the LCD be withdrawn.” Takeaway: Palmetto GBA is moving forward with new immunohistochemical staining guidelines.

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