PRECISION MEDICINE

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Using Nuclear Stress Tests as Screening Procedure = Medical Necessity Violation Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing … [Read more...]

DISTRIBUTION AGREEMENTS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

The pattern of high volume and relatively low impact continued with strategic alliances outnumbering acquisitions at rate of roughly 3:1. M&A Following the trio of mega-deal closings, … [Read more...]

REVENUES

Dx Earnings Report: Strong Q3 Adds to Robust 2017 as PAMA Looms for 2018

Big labs continue to post impressive earnings. But the positive Q3 numbers may prove to be the calm before the PAMA storm—at least for major reference labs that generate significant revenues from … [Read more...]

INDUSTRY BUZZ

FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval

For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests. On Nov. 6, the agency finally made a move in that direction … [Read more...]

COMPLIANCE CORNER

Medicare Exclusions: One Week, Two Different Labs Get the Boot

Exclusion of a clinical lab from participating in Medicare or other government health programs is a relatively rare penalty. But last month, there were two of them reported in the span of less than a … [Read more...]

LAB SAFETY

CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]

COMPLIANCE

Medicare Reimbursement: CMS Finalizes Hospital Outpatient Prospective Payment Changes for 2018

With all of the PAMA commotion, the 2018 Medicare Hospital and Ambulatory Surgical Outpatient Prospective Payment System (OPPS) final rule has flown under the radar. In case you don't feel like … [Read more...]

ENFORCEMENT

OIG Work Plan Monthly Review: November 2017

The OIG added four new items to its Work Plan this month, all of which have potential indirect effects on clinical labs involved in providing the targeted services. 1. Opioids in Medicaid: Concerns … [Read more...]

NEWS

Millennium Labs Bankruptcy Plan Stays on Track despite Lender Opposition

It has been nearly two years since Millennium went into Chapter 11 but the case continues to make news. After agreeing to pay $250 million to settle federal fraud claims for false billing of urine … [Read more...]

COMPLIANCE PERSPECTIVES

CMS Finalizes Controversial PAMA Fee Schedule

It's official. Brushing aside fierce lab industry opposition, CMS has decided to go forward with its PAMA Clinical Laboratory Fee Schedule (CLFS) in 2018. The Flawed Fee Schedule The intent of the … [Read more...]


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