News at a Glance – May 2015

CAP and ADASP Recommend Secondary Review of Anatomic Pathology Cases: The College of American Pathologists (CAP) and the Association of Directors of Anatomic and Surgical Pathology (ADASP) have developed a “new evidence-based guideline to provide recommendations for secondary and timely reviews of surgical pathology and cytology cases to improve patient care.” The guideline, titled “Interpretive Diagnostic Error Reduction in Surgical Pathology and Cytology,” was published on the website of the Archives of Pathology & Laboratory Medicine as an Early Online Release. The guideline addresses the analytical phase, in which pathologists use “inherent judgment” while interpreting slides. CAP and ADASP created an expert panel of pathologists which studied the potential for errors during this phase. The panel made five recommendations which call for institution of secondary review by another pathologist, on a timely basis but ideally before diagnosis; suggest reviews should be devised to accommodate the circumstances of the specialty or pathology group and be documented; and advise results should be monitored and changes instituted to address areas of disagreement or error. The guideline will be reviewed every four years unless new evidence arises that could substantially impact the guideline recommendations. Individuals Sentenced for Diagnostic Testing Schemes: Yet another physician has been sentenced in connection with the Biodiagnostic Laboratory Services LLC (BLS) case. Franklin Dana Fortunato of Montville was sentenced to 14 months in prison with a year supervised release and a $75,000 fine and $635,0000 forfeiture. He previously had admitted accepting bribes in exchange for referral of blood specimens and pleaded guilty to violating the federal Travel Act and filing a false tax return. Fortunato admitted he didn’t declare the bribes as income. The government alleged he failed to pay $160,000 in taxes for the undeclared bribes and other payments such as patient co-pays and funds received from other providers. So far, 38 individuals—including 26 physicians—have pleaded guilty in this case. In a separate matter, the owner of another New Jersey diagnostic testing facility, Vijay Patel, was sentenced to 12 months in prison after having pleaded guilty to one count of health care fraud for submitting Medicare claims for diagnostic testing services that a cardiologist had performed. The U.S. Attorney explained the cardiologist performing the services was subject to pre-payment review and avoided such review when Patel submitted the claims as if his diagnostic testing facility had performed the services.The government said Patel kept part of the payment received and remitted the rest to the cardiologist. Palmetto GBA Issues Proposed Draft LCD for Oncotype DX® Prostate Cancer Assay: Prostate cancer testing has received significant attention lately as the industry seeks to find reliable ways of identifying the appropriate treatment strategy for patients diagnosed with such cancer. Recognizing the difficulty in distinguishing patients needing aggressive treatment and those that could be observed, Palmetto is proposing coverage of an assay that measures cancer aggressiveness. The proposal would cover the Oncotype DX® if there’s been a “needle biopsy with localized adenocarcinoma of prostate,” the patient’s stage is either very low risk disease or low risk disease, there’s a life expectancy of 10-20 years and other conditions are met. The patient’s medical record must demonstrate medical necessity for the services. The comment period ends July 24, 2015.