FDA

LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims

The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict patients' responses to medications. It began in 2018, when the FDA warned consumers and … [Read more...]

CMS

FDA Watch: Agency Okays EIA Technology-Based Lyme Assays

Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses … [Read more...]

CMS

Environmental Briefing: New EPA Laws Ban Flushing of Opioids & Other Hazardous Pharmaceuticals

On Aug. 21, a new federal rule took effect banning labs and other healthcare facilities from flushing hazardous waste pharmaceuticals into the sewer system. If you haven't already done so, you'll need … [Read more...]

CMS

Newly Proposed CMS Hospital Transparency Rules & their Impact on Labs

It's an all too common occurrence. You or a loved one require an in-hospital procedure, but you have no idea of what the out-of-pocket costs will be. Afterwards, you get hit with an enormous bill that … [Read more...]

COMPLIANCE GUIDANCE

Stark Law: CMS Plan Would Make It Easier for Labs to Get Advisory Opinions

In late July, CMS proposed to update the advisory opinion process that labs and other providers use to get a determination about whether a proposed business arrangement would violate the Stark Law. … [Read more...]

CMS

FDA Issues Guidance on Submitting NGS Data for Antiviral Drugs

On July 18, the FDA issued final guidance on submission of next-generation sequencing (NGS) data from resistance assessments performed in the development of antiviral drug products. The new Technical … [Read more...]

FDA

Inside Washington: What’s Going on with Regulation of LDTs?

Although things appear to be quiet, progress is actually being made in the quest to create workable regulation of Laboratory Developed Tests (LDTs) developments. Here's a rundown of the latest … [Read more...]

ENFORCEMENT

Enforcement Actions: Doctors Pay $1.1 Million to Settle Genetic Test Kickback Claims

Kickbacks for genetic test referrals has become a focus of recent federal enforcement action. The most recent case involves three doctors and a cardiology practice that allegedly accepted bribes from … [Read more...]

FEE SCHEDULES

Medicare Reimbursement: CMS Publishes New CPT Codes

CMS recently published new CPT codes taking effect on Oct. 1, 2019. All the codes have a Type of Service (TOS) code of 5, and the codes are contractor-priced until they appear on the Jan. 1, 2020 CLFS … [Read more...]

COURT CASES

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

Federal Court Dismisses Whistleblowers' Urine Drug Test False Billing Claim Case: Whistleblowers accused a national lab company of falsely billing Medicare and Medicaid for high complexity … [Read more...]


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