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
January 13, 2020
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
January 2, 2020
"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
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...]
COMPLIANCE GUIDANCE
HIPAA: New HIPAA Penalties System Rewards Labs that Try to Comply
August 12, 2019
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
June 17, 2019
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
June 17, 2019
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
April 15, 2019
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
January 14, 2019
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
November 16, 2018
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...]
