Continued ‘Aggressive Audit Tactics’ by Private Payers and Government Regulators Following 2018 Medicare Part B Price Cuts Will Strain Profitability of Clinical Laboratories, Pathology Groups

Medical laboratory leaders must take steps to protect their lab’s financial stability and know how to prepare and respond to investigations and regulatory threats Clinical laboratories and anatomic pathology groups may soon face a new normal that includes more frequent and tougher audits by both private payers and the government, resulting in larger monetary demands. The financial strain medical laboratories will experience from more aggressive audits will be compounded by the roll out on...

Federal Judges Block Anthem-Cigna and Aetna-Humana Deals to Protect Market Competition and Healthcare Consumers

Mergers that would have reshaped the nation’s largest insurance companies would directly affect the provider networks independent medical laboratories rely on For pathology groups and medical laboratories, the news about two thwarted deals involving mega insurance companies might be seen as a positive development. The proposed deals—Anthem’s $48-billion bid to buy Cigna, and a proposed $37-billion Aetna–Humana merger—would have reshaped the US health insurance industry had they not been...

Could ‘Money Back’ Guarantees Become More Common for Medical Devices, Clinical Laboratory Tests, and Prescription Drugs as Manufacturers Strive to Prove Clinical Value?

Examples already exist of manufacturers agreeing to refund payments if their therapeutic drugs don’t benefit patients; Medical laboratories with proprietary tests may find this strategy effective at guaranteeing the clinical utility of their assays If their medical devices, medical laboratory tests, or prescription drugs are not effective, will payers, patients, and doctors get refunds from the manufacturers of these products? Some experts predict that the increased emphasis on improved...

More Insurers Willing to Cover Whole Exome Sequencing (WES) in a Trend That Creates New Opportunities for Clinical Pathology Laboratories to Add Value

Most insurers still determine coverage on a case-by-case basis, but two major payers now have coverage policies that are helpful to clinical labs that perform WES Whole exome sequencing (WES) is not new for clinical pathologists, but it is becoming more common in a clinical setting as more physicians learn about its uses. This is due to two reasons. First, researchers are identifying new ways to use whole exome sequencing to improve patient care. Second, the cost of whole genome sequencing...

More Doctors to See Jail Time in Biodiagnostic Laboratory Services Case, but Question Remains: Will Federal Prosecutors Send Lab Executives and Doctors to Jail in the Health Diagnostics and Singulex Case?

Recent federal Justice Department memorandum issues guidance designed to seek accountability from individuals and combat corporate misconduct Pathologists and clinical laboratory managers who want a tougher crackdown on labs and physicians that violate anti-kickback laws welcome the news that in the past year federal courts have sentenced 13 physicians to jail terms of 12 to 63 months for accepting bribes from a discredited medical laboratory company as part of a scheme to defraud the federal...