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...]
CMS
FDA Watch: Agency Okays EIA Technology-Based Lyme Assays
September 23, 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...]
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...]
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...]
CMS
Kickbacks: OIG Withdrawal of Old Safe Harbor Proposals Clears Way for Meaningful Reform
August 26, 2019
Like the rest of the health care industry, labs need more not fewer new and modern Anti-Kickback Statute (AKS) safe harbors. So, the OIG's decision to cancel new safe harbors in incubation seems like … [Read more...]
COVERAGE
Medicare Coverage: NGS Testing of Early-Stage Cancer Patients Is Back in Play
June 17, 2019
The reimbursement outlook for those who provide next generation sequencing (NGS) testing to early-stage cancer of Medicare patients with hereditary risks is far brighter today than it was a few weeks … [Read more...]
ANTI-KICKBACK
CMS Says Big Changes Are in Store for Stark Law by End of Year
March 25, 2019
The Stark Law is like the weather: Everybody talks about it but nobody does anything about it. But that all may be about to change if CMS Administrator Seema Verma is to be believed. During her recent … [Read more...]
REIMBURSEMENT
The Newest PAMA Controversy: The GAO Report & Intervention of a Powerful Senator
March 25, 2019
The recent moves by CMS to include certain hospital outreach labs as "applicable laboratories" for purposes of PAMA reporting and pricing (see National Intelligence Report (NIR), Dec. 31, 2018) has … [Read more...]
