Scorecard: OIG Enforcement Actions against Labs in 2019

Labs remain at the top of the OIG’s enforcement hit list, as illustrated by the number of cases involving labs cited in the agency’s new Semiannual Report to Congress for FY 2019: False Billing … [Read more...]

FDA Resounds the Alarm on Biotin Test Interference

In early November 2019, the FDA undated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning to lab … [Read more...]

Genetic Testing: CMS Proposes Expanding NGS Testing Eligibility

In a reversal, CMS is now proposing to cover FDA-approved or -cleared germline NGS testing for breast and ovarian cancer patients who have risk factors that suggest they should receive testing to … [Read more...]

CLIA: CMS Revises State Operations Manual for Labs

In late September, the Centers for Medicare and Medicaid Services (CMS) released QSO-19-20-CLIA: Revisions to State Operations Manual (SOM), Chapter 6—Special Procedures for Laboratories. The release, … [Read more...]


Hospital Labs: CMS Pushes Forward with Controversial Price Transparency Rules

Brushing aside the intense objections and negative feedback, CMS pressed forward with price transparency by including as part of the 2020 Outpatient Prospective Payment System final rules the … [Read more...]


The Year in Labs Regulation: The 6 Biggest Stories of 2019

"May you live in interesting times.” This ancient Chinese curse extolling the virtues of stability may resonate with those of you who work in the lab industry and have a stake in federal … [Read more...]

Current Issue of NIR

  Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download NIR content: I agree that I am the the only person who is … [Read more...]


Pay rates, vacations while recovering, gig economy

By Mike O’Brien bio Department of Labor enters final stage of update to ‘regular rate’ rule under FLSA. As we have discussed previously in these updates, the Department of Labor has been working to … [Read more...]


New Laws: Proposed Kickback Changes Would Provide Needed Relief But Also Largely Exclude Labs

In what could be the most significant story in health care fraud and abuse compliance of the past several years, the CMS and OIG proposed new rules (the Proposal) to adapt 20th century kickback laws … [Read more...]


New Product Development: FDA Issues Final Guidance on IVD Oncology Trials

On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in an oncology clinical trial is … [Read more...]