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Four Labs and Billing Company Pay $140,000 Fine in HIPAA Case
WHEN A BILLING SERVICE company disposes of patients’ lab test records, it should do so in compliance with federal and state privacy rules. That means all protected health information (PHI) should be shredded or incinerated. Four pathology groups in Massachusetts learned this lesson the hard way wh…
Lawyer Advises on Risk Of Prostate Biopsy Audits
CEO SUMMARY: For labs currently processing prostate biopsy cases with five or more cores and for those pathologists interpreting those cases, there is a lack of clarity about new Medicare policies. As one example, risk of an audit is significant because of recent guidance issued by one Me…
Prostate Biopsy Claims Affected by Policy Change
CEO SUMMARY: Quietly, with no fanfare and little advance public notice, the Medicare program is taking steps to change reimbursement policy for prostate biopsies. On August 7, 2012, Palmetto GBA adopted the new policy published on January 1, 2012, by the National Correct …
CLIA’s Catch-22 Involving Proficiency Testing
THERE’S A REGULATORY TRAP awaiting the unwary laboratory organization. It involves language in CLIA rules for proficiency testing (PT). All medical directors and lab administrators will want to fully understand the implications of what appears to be an emerging trend in CLIA laboratory enforcement….
Inadvertent PT “Errors” Trigger CLIA Sanctions
CEO SUMMARY: Despite taking appropriate steps to complete proficiency testing (PT), in recent years an unknown number of labs were determined to be in violation of CLIA requirements. Federal regulators are enforcing penalties ranging from suspension of the labs’ licenses to transition t…
How One Pathology Group Survived Its First RAC Audit
CEO SUMMARY: Last summer, InCyte Pathology in Spokane, Washington, found itself facing demand letters from the recovery audit contractor (RAC) responsible for that region. The RAC auditor was questioning claims for technical component (TC) services and seeking repayment from InCy…
Lawyers Provide Insights About Top Legal Concerns
CEO SUMMARY: After conducting the first-ever survey of the most important legal, compliance and managed care concerns for clinical labs and pathology groups, THE DARK REPORT asked leading lab industry attorneys who participated in the survey to say a few words about these topics….
Key Legal, Compliance Issues for Labs Identified
CEO SUMMARY: It’s a first in the lab industry. In recent weeks, THE DARK REPORT asked the nation’s leading attorneys in clinical lab and anatomic pathology law to identify the most important legal, compliance and managed care issues for 2011 and 2012. Using a consensus method…
Pathology Group Establishes Lab Test Exchange Networks
CEO SUMMARY: After several decades of steadfastly maintaining their independence from other pathology groups in their community, progressive hospital-based pathology groups are beginning to create regional laboratory testing networks. These collaborations generally start small an…
How Labs Should Comply With New Signature Rule
CEO SUMMARY: Across the nation, clinical laboratories and pathology groups are reacting to the new Medicare rule that requires a physician signature on a paper requisition for clinical laboratory tests. Laboratories using paper requisitions will need to add a signature line, then…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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