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...]

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...]

CMS

Kickbacks: OIG Withdrawal of Old Safe Harbor Proposals Clears Way for Meaningful Reform

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...]

Compliance Heads Up: New Kickback Safe Harbors Rule Is Almost Ready

After months of promises, posturing and public consultation, the Department of Health and Human Services is getting ready to unveil a proposed rule to liberate labs and other providers from the … [Read more...]

COMPLIANCE

New OIG Report Confirms that Labs Are Still on the Enforcement Radar

After a recent dip, OIG enforcement activity has seemingly rebounded, at least in terms of total recoveries. That's the basic punchline from the newly published OIG Semiannual Report to Congress … [Read more...]

COVERAGE

Medicare Coverage: NGS Testing of Early-Stage Cancer Patients Is Back in Play

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...]


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