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
Stark Law: CMS Plan Would Make It Easier for Labs to Get Advisory Opinions
September 9, 2019
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...]
LAB SAFETY
The Safety Interpretation
September 10, 2018
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio When hospitals were placed on OSHA's list of "high-risk" workplaces, no one had to ask why. OSHA adjusts that list based on the number of … [Read more...]
SETTLEMENT
Connecticut Hospital Settles Self-Disclosed Stark Violations for $423K
July 20, 2018
Case: A major settlement in Connecticut in June was authored by Hartford Hospital after it made the mistake of leasing office space to a physician practice (and Medicare referral source) at below … [Read more...]
COMPLIANCE
Enforcement Trends: New Fraud Takedown Focuses on Opioid Drugs & Sophisticated Financial Schemes
July 13, 2018
The 2016 health care fraud takedown was the biggest in history; the 2017 version surpassed it; and the June 2018 reprise nearly doubled the 2017 effort, at least in terms of the false claims dollars … [Read more...]
