A recent whistleblower case involving the Mayo Clinic provides a unique perspective on what documentation is required to meet the conditions of payment for surgical pathology claims and seems to overturn a long-held understanding concerning reporting for certain surgical pathology billing codes. Compliance officers (COs) can gain valuable insights into the complexity of billing and documentation requirements for surgical pathology services by reviewing the court document from the Sept. 4 Eighth Circuit ruling dismissing an alleged False Claims Act (FCA) violation by the Mayo Foundation. These insights may be valuable in decisions a CO may be faced with in the future. In the case, the Eighth Circuit Court agreed with a lower court’s decision when it held that Mayo did not violate the FCA by choosing not to create separate written reports for every permanent slide it prepared and reviewed in each medical case it reported (Ketroser et al. v. Mayo Foundation et al., case number 12-3206). The relators, David Ketroser, Gary Latz, Robert Smith, and Jason Kennedy, argued that Medicare regulations required a written report for every permanent slide a laboratory billed to Medicare. As a result, they alleged that Mayo “habitually submitted false claims for Medicare payment of surgical pathology services not provided.” However, the relators failed to provide even one example of a claim Mayo submitted to Medicare seeking payment for surgical pathology services. According to the court document, FCA liability attaches to the actual claim for payment, not to an underlying allegedly fraudulent activity. Without at least one claim to substantiate its FCA allegation, the court was frustrated and pointed to what it called a “well established principle” that a relator alleging a systematic practice of submitting false claims, as is the case here, must provide some representative example of the alleged fraudulent conduct. No Separate Reports Laboratories providing surgical pathology services covered under Current Procedural Terminology (CPT) codes 88300 though 88309 are well aware that a report issued by a pathologist on any particular medical case must account for all procedures done to reach a final diagnosis, including any special stains or additional slide reviews, if the laboratory is going to bill for those services. The relators in this case interpreted Medicare regulations to mean that a separate written report must be prepared for any permanent slides prepared, reviewed, and billed. They also believed that the conditions of payment for these CPT codes required these separate reports. The court reviewed the CPT descriptions and the Medicare regulations and found that no such requirements existed. Instead, it found that CPT codes 88300 through 88309 required “reporting” but did not explicitly require separate written reports for each slide examined for a particular surgery. As support for its ruling, the court pointed to another category of pathology services, “clinical consultation services,” which requires a “written narrative report” included in the patient’s medical record. The court inferred from this comparison, and another comparison for diagnostic ultrasound that also specifically requires a written report, that if a written report was required for each slide, the CPT code book would specify that requirement. The court then turned to the relators’ claim that it was a “standard industry practice” to generate such reports. The standard industry practice claim was based on a College of American Pathologists recommendation published in an article in the Archives of Pathology & Laboratory Medicine 1608 (October 2008) titled, “Reporting Guidelines for Clinical Laboratory Reports in Surgical Pathology.” This does not constitute evidence that Medicare expects written reports for every permanent slide, the court said. The court pointed out that the authors were considering what must be done for each surgical case, not for each specimen in a case. The relators desired “that the Medicare regulation and CPT Codebook be interpreted to require a separate written report for each permanent slide that is billed as a separate surgical pathology service. This fails to state an FCA claim of knowing fraud,” said the court. The relators pleaded a claim of regulatory noncompliance, not a plausible claim of false or fraudulent claim submittals by Mayo. Conclusions Laboratory COs can learn several valuable lessons from this case, not the least of which is that we cannot rely on what we think the rules or regulations require; we must research regulations and make objective analysis or interpretations of those regulations or Medicare payment rules. Documentation of what your lab has done or not done, and the reasons and basis for why a particular decision was made, are important documents and should remain part of the permanent record of policies and procedures. Takeaway: Whistleblowers in a lawsuit against Mayo Clinic misinterpreted Medicare requirements regarding pathology billing. The case provides important lessons for compliance officers, who should always stay abreast of court rulings concerning compliance and billing.