Inside the Lab Industry: In Bid to Cut Down Overutilization, Palmetto Issues Coverage Advisories on GI Staining, Breast Cancer Testing

Keith Kaplan, M.D., recalled the day he encountered that might be best described as a huge stain on slide staining. That was when he was practicing in the Midwest and a patient with suspected colorectal cancer went to Kaplan’s large health care organization for a second opinion. A liver biopsy was ordered, with an outside lab performing special staining. Eighteen immunohistochemical stains were performed altogether. “You may need to do two or three immunohistochemistries in a situation like that. Not 18, not six to eight times what is required,” said Kaplan, who now practices in North Carolina and is best known as the creator of the Digital Pathology blog, which he has been publishing since 2007. According to Kaplan, who has delved into the issue of special staining on his blog on occasion, overutilization of special staining indeed exists in gastric pathology, primarily in a bid to drive up revenue for the practice or laboratory performing it. The stains are reimbursed anywhere from $12.12 to $97.65 apiece, depending on how they are coded. Kaplan may be the most outspoken in the lab sector on this particular issue, but he definitely is not alone. Palmetto GBA, the Medicare administrative contractor (MAC), recently issued revised payment guidelines—its leadership prefers the term “education articles”—regarding special stains for gastrointestinal (GI) pathology, as well as for breast cancer assays. Regarding the GI stains, Palmetto stated on its Web site that “the vast majority of conditions of the stomach on biopsy can be diagnosed by the use of the routine hematoxylin and eosin (H&E) stain alone. There is potential for either overutilization or under-utilization of these ancillary special stains. In most cases it is NOT reasonable or necessary to perform ‘special stains’ such as alcian blue (AB) - periodic acid schiff (PAS) to determine if clinically meaningful intestinal metaplasia is present. In addition it is not usually reasonable or necessary to perform special stains or immunostains (IHC) to determine the presence of H. pylori.” Palmetto suggested that special stains should be conducted on 20 percent or fewer gastric biopsies and that pathologists conduct occasional self-assessments in order to ensure that they do not exceed that threshold. On the breast cancer issue, Palmetto observed that “based on recommendations from the College of American Pathologists, the American Society of Clinical Oncology, and the National Comprehensive Cancer Network, hormone receptor assays, estrogen receptor (ER), progesterone receptor (PR), and Her-2/neu are the only current biomarkers that demonstrate standardized value in breast cancer pathology evaluation.” As a result, Palmetto said it would no longer allow payments for Ki-67, PI3K, and gene expression assays, noting that “no proven standardized value has been established.” The Ki-67 gene is normally an indicator of overall prognosis and tumor aggressiveness, but given that five-year survival rates for breast cancer are more than 90 percent in stage two and more than 70 percent in stage three, it often is not needed. “[It] never became the standard of care,” said Robert Boorstein, M.D., who heads the ClasGroup, a New Jersey-based pathology consulting firm. Elaine Jeter, M.D., Palmetto’s medical director, said the organization had detected overutilization in the two areas and took the necessary steps to neutralize inappropriate practices. “Palmetto GBA and others are always using data analytics to identify where utilization may appear to be inconsistent with standards of care or other established practice guidelines,” she said. “When we identify these scenarios we address the issues with education, claim reviews, and/or policy development depending on the nature and scope of the potential problem.” The Government Accountability Office has also chimed in on the issue. In June 2013, it issued a report concluding that the use of stains among pathologists rose 400 percent among self-referring practices between 2004 and 2010. Even among those practices that did not engage in self-referrals, the number of stains rose by 150 percent. Different Sides to Issue The changes appear to have pitted the more outspoken members of the pathology community who believe less is more when it comes to making diagnoses, versus those who are chafing against what they see as outsiders telling them how to run their laboratories and practices. Kaplan is firmly in the less-is-more camp. “A couple of years ago, I had a colleague who told me he couldn’t diagnose intestinal metaplasia in the esophagus without a stain,” he recalled. “I advised him if that was the case, he shouldn’t read those cases.” Boorstein acknowledged that while there is a wide variability in how stains are used, he also believes that multiple staining is not always necessary. “If most pathologists are able to make the diagnosis without the special stains or immunohistochemistry, what does that tell you—that you can make the diagnosis without them,” he said. The reasons behind the variability in staining—and propensity toward its overuse—is complex. Kaplan believes it begins during medical residencies, when some pathologists are trained by other clinicians who have tended to err toward staining. He also believes that some pathologists leaning toward a specific diagnosis but not completely sure will order the stain to be more certain. However, other factors come into play down the line, including some patients asking for every deliberate test to confirm a diagnosis. But both Kaplan and Boorstein also believe that business considerations play a significant role. “The places I have worked, that has not been an area of overuse, but [they] have not had a business model for overordering special stains,” Boorstein said. But Kaplan has experienced such overuse, including a large hospital system where he claimed overstaining was systemic. As a result, he often reported the stain as being noncontributory, which zeroed out payment for the stain’s professional component. And he and other colleagues would remove patient charges if they did not believe they should have to pay for the stain. “First and foremost, pathologists, lab administrators, and business managers saw a way to generate revenue,” Kaplan said of the overutilization. CAP Objections No pathologists who are against Palmetto would speak on the record regarding the guidelines, although there has been some grousing about the change. In particular, there has been anger that issuing an advisory guideline intended to discourage claims submissions short-circuits the process for creating a local coverage determination. That is a far more onerous process. It requires the MAC to devise alternatives to denying coverage, to seek input and comments from stakeholders, and also allows legal challenges in administrative law court—all of which can take years to resolve. That is among the reasons the College of American Pathologists has voiced strong concerns about the move. The lobbying group said in a statement that it “objects to Palmetto’s continuing practice of using its Website to post articles that seem to establish new payment restrictions on pathology services without the benefit of those restrictions being vetted through the required local coverage determination process. The CAP will continue to advocate strongly with [Centers for Medicare and Medicaid Services] that its Medicare Administrative Contractors adhere to the established requirements of the local determination process to implement changes to existing Medicare payment policy.” Meanwhile, Kaplan believes that Palmetto will eventually focus on other areas of potential overutilization. “I am pretty certain the prostate triple stain will be next,” he said. Jeter confirmed that her organization is looking at other potentially overused procedures. Takeaway: Palmetto GBA’s move toward restricting test processes it sees as overutilization may or may not be adopted throughout the sector, but it is creating a debate regarding how pathologists should practice and how local coverage determinations should be promulgated.