MARKETING

Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service

The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect 33 variants for multiple … [Read more...]

LEGISLATION

New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more

By Danielle Sloane bio and Chris Climo bio In a recent piece of federal legislation intended to address the opioid crisis across the United States, Congress enacted a new all-payor kickback … [Read more...]

FOCUS ON

LDTs: FDA Announces New Approach to 510(k) Approvals

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]

CMS

Post-PAMA: Government Report Warns of Medicare Overspending(!) for Lab Tests

As if the deep price cuts inflicted by PAMA weren't infuriating enough, now the US Government Accountability Office (GAO) is claiming that labs may be getting overpaid. In a report issued late … [Read more...]

FOCUS ON

Medicare Reimbursement: CMS Provides Needed PAMA Relief—But Newly Covered Hospital Labs Must Report in 2019

The battle between CMS and the lab industry over Medicare Part B pricing for lab tests could be on the road to resolution notwithstanding the ACLA's recent court loss. But even as the legal battle … [Read more...]

CORRECTION

Correction: PAMA Relief—CMS 1450 14x TOB Labs DO Count!

Two articles appearing on the G2 website, "CMS Offers Some PAMA Relief But Not Nearly Enough" (G2 Compliance Advisor/Lab Compliance Advisor) and "2019 CLFS Offers Some PAMA Relief But Not Nearly … [Read more...]

PUBLIC HEALTH

Industry Buzz: Obamacare Repeal Sends Tremors through Insurance Markets

What came as a Christmas gift to many Republicans may be a lump of coal in the stocking of many others. On December 14, a federal judge in Texas ruled that the entire Affordable Care Act (aka, … [Read more...]

INNOVATION

Using Digital Technology and AI to Fight Cancer

It has the makings of a Hollywood movie. Three recent college grads start a medical testing software company that uses a digital pathology platform, meet with success, and then go on to utilize … [Read more...]

MARKETING

Industry Trends: Continued Momentum for Lab-Retail Collaboration

The Theranos debacle hasn't dissuaded retailers from partnering with labs. Here's a rundown of some recent deals. LabCorp & Walgreens In fact, Walgreens, Theranos's ex-retail partner, has moved … [Read more...]

PUBLIC HEALTH

FDA Watch: Agency Approves New Flu Tests and Drug

As the flu season begins, the FDA has issued significant approvals of new products for diagnosing and treating the disease. New Flu Assays On October 24, Abbott announced that the FDA has granted … [Read more...]


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