ANTI-KICKBACK

Case of the Month: Individual Principles Hit with $114.1 Million Verdict for Role in HDL Blood Test Fraud

Roughly three years ago at this time, mega-scandals were in the news featuring diagnostic giants like Millennium, Health Diagnostic Laboratory (HDL), Biodiagnostic Laboratory Service and the like. But … [Read more...]

REIMBURSEMENT

Enforcement Trends: OIG Report Suggests that Urine Drug Testing Is Making Labs a Juicy Target Once Again

The Office of Inspector General just published its Semiannual Report to Congress (covering Oct. 1, 2017 through March 31, 2018). Here are the key things labs and lab managers need to know about this … [Read more...]

HEALTH CARE REFORM

ACA: DOJ Won’t Defend Individual Mandate in Court—But 16+ States Will

One of the DOJ's principal roles is to defend the federal laws in court cases challenging their constitutionality. But the agency has made it known that it will not be doing that in a lawsuit brought … [Read more...]

FEE SCHEDULES

PAMA Reimbursement: CMS Explains How to Get ADLT Status for New Lab Tests

Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new PAMA Part B payment rules for lab tests remains a work in progress. On March … [Read more...]

REVENUES

DX Earnings Report: PAMA Cuts Make Little Dent on Q1 Lab Earnings

One quarter into its existence, the new PAMA Medicare Part B fee schedule seems to be having only a marginal impact on at least publicly traded labs. In fact, the recently published Q1 earnings … [Read more...]

COMPLIANCE

Medicaid Fraud: Enforcement Continues to Trend Down as Labs Drift Deeper into the Background

Last month, the OIG published its annual summary of Medicaid Fraud Control Unit (MCFU) activity for FY 2017. Here is a summary of the key findings, trends and impact on labs. Background The 50 MCFUs … [Read more...]

COURT CASES

Industry Trends: Small Labs Relying on Antitrust Laws to Protect Their Market Position

Frustrated by the consolidation taking place within the medical lab testing market, small and mid-sized labs that have not been swallowed up are fighting back by filing antitrust lawsuits against the … [Read more...]

FALSE CLAIMS

Enforcement Trends: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests

While the federal enforcement community has made urine drug testing of opioid drug patients its number one target for lab-related False Claims Act (FCA) charges for the time being, nuclear stress … [Read more...]

FOCUS ON

Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer

In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements: Sharply lower prices for traditional tests; and Wider coverage of newly emerging tests, including some that … [Read more...]

ENFORCEMENT

Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers

One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the target firm. Now one of those cases … [Read more...]


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