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
September 9, 2019
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
September 9, 2019
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
September 9, 2019
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
September 9, 2019
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
September 9, 2019
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?
September 9, 2019
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
September 9, 2019
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
September 3, 2019
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
August 26, 2019
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...]
