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 Heads Up: New Kickback Safe Harbors Rule Is Almost Ready
June 25, 2019
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
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...]
ENFORCEMENT
From Blood Screen to Silver Screen: The Theranos Story Goes Hollywood
April 15, 2019
Clinical labs are not usually the stuff of Hollywood. But the story of Theranos and its charismatic leader has attracted filmmakers the way regular law-abiding labs never do, spawning not one but a … [Read more...]
OSHA
Compliance Perspectives: A 10-Step Compliance Strategy for OSHA Recordkeeping Rules
February 5, 2019
January is the season when employers must compile their OSHA logs for the previous year. The good news is that many labs are exempt from these requirements. Here's an overview of the OSHA … [Read more...]
COMPLIANCE
Enforcement Trends: After 2017 Decline, False Claims Act Healthcare Recoveries Bounce Back
January 21, 2019
Although the False Claims Act (FCA) remains a federal enforcement cash cow, the growth rate has fallen off in recent years, at least in the healthcare sector. But that short-term trend could be in … [Read more...]
ENFORCEMENT
Provider Fined for Not Taking Compliance Measures Required by Its CIA
January 19, 2019
Case: Nearly 10 years ago, a new Affordable Care Act rule requiring labs and other providers to investigate their credit balances for potential Medicare overpayments took effect. In 2015, Pediatric … [Read more...]
ENFORCEMENT
New Law: EKRA Makes Drug Addiction & Rehab Labs Potential Targets for Federal Prosecution
January 15, 2019
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of abuse banned by the … [Read more...]
LEGISLATION
Compliance Alert: New Private-Pay Opioid Law Puts All Drug Addiction & Rehab Labs at Risk of Federal Prosecution
January 7, 2019
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of abuse banned by the … [Read more...]
HEALTH CARE REFORM
Compliance Perspectives: PAMA Pitfalls & Survival Strategies
December 31, 2018
PAMA's deep Medicare reimbursement cuts have had a devastating impact on the lab industry. Recent CMS changes in the 2019 Final Rule should provide a degree of pricing relief but not until 2021. In … [Read more...]
