Coronavirus

How Coronavirus Public Health Emergency Offers Potential for Temporary Stark Relief

On Jan. 31, 2020, the U.S. Department of Health and Human Services declared novel coronavirus, aka, COVID-19, a public health emergency (PHE). While it might sound like the highest level of government … [Read more...]

In Brief: OIG Opens Second Avenue for Anti-Kickback Statute Revisions

Even as we wait for the second draft of the proposed new value-based kickback relief rules—see National Intelligence Report (NIR), Nov. 15, 2019—the OIG issued its annual call for recommendations for … [Read more...]

NEWS

The Year in Labs Regulation: The 6 Biggest Stories of 2019

"May you live in interesting times.” This ancient Chinese curse extolling the virtues of stability may resonate with those of you who work in the lab industry and have a stake in federal … [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...]

COMPLIANCE GUIDANCE

HIPAA: New HIPAA Penalties System Rewards Labs that Try to Comply

New HHS rules significantly increase the amount of money your lab can save by making diligent and demonstrable efforts to prevent HIPAA violations even when those efforts don't succeed. We're … [Read more...]

COMPLIANCE

DOJ Explains What It Wants from a Compliance Program

While it may not prevent all violations, the right compliance program can help your lab get lighter penalties if things go wrong. But what exactly is "the right compliance program." On April 30, 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...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [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...]

COMPLIANCE GUIDANCE

Kickbacks: OIG Okays Incentivizing MDs to Order More Early Screening Tests

Proactive rather than reactive has become a mantra of the modern health care model. Early and periodic testing of patients is a critical element in this strategy. The problem is that not a lot of … [Read more...]


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