NEW LAW

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

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...]

CMS Delays Controversial Hospital Price Transparency Rules

CMS has decided to delay its controversial proposal to require hospitals to post their standard prices based on their negotiated contracts with insurers. But while the delay represents a temporary … [Read more...]

Reimbursement: CMS Increases 2020 AIC Medicare Appeal Thresholds

Appealing Medicare denials and other unfavorable decisions will be just a tad more difficult in 2020. Here’s why: Medicare AIC Thresholds Medicare rules (specifically, Section 1869(b)(1)(E) of … [Read more...]

Quest Shells Out $195K to Settle Massive HIV Data Breach Class Action  

Government fines, public embarrassment, loss of provider and patient trust. As if these consequences weren’t scary enough, massive PHI breaches can expose your lab to a new kind of risk: class action … [Read more...]

Global News: EU Delays Launch of Eudamed Database

The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022.  Originally, manufacturers were supposed to be compliant by May 2020 with … [Read more...]

PAMA Report: ACLA Tries for Decisive Blow in Federal Court Case

Now that its lawsuit challenging the PAMA pricing scheme is back in the lower federal court, the American Clinical Laboratory Association (ACLA) went back on the offensive by moving for summary … [Read more...]

Industry News

Kellison and G2 Intelligence Honor Dr. Sidney Goldblatt

Dr. Sidney Goldblatt, MD, is the 2019 recipient of the Kellison Public Service Award. Dr. Goldblatt has been founder, medical director and CEO of Molecular Dx; founder and CEO of Goldblatt Systems; … [Read more...]

Medicare Reimbursement: CMS Eases Coverage Restrictions on NGS Testing of Early-Stage Cancer Patients

After years of resistance, CMS is now prepared to pay for germline (inherited) next-generation sequencing (NGS) testing of Medicare early-stage cancer patients under certain conditions. Here’s a look … [Read more...]

CO-ORDINATING DATA

Laboratory Information Systems (LIS): What You Need To Know To Get Paid

By Sean McSweeney  bio Today, laboratory billing claims require more and more data to successfully get paid. One of the biggest reasons your claims may be getting denied is because you're not … [Read more...]


(-00000g2)