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
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...]
MACRA REQUIREMENT
How to Adjust to the April 2018 Medicare Beneficiary Cards
July 9, 2018
By Sean McSweeney bio In a press release on May 30, 2017, the Centers for Medicare & Medicaid Services (CMS) commented regarding their fraud prevention initiative program and their … [Read more...]
FEE SCHEDULES
PAMA Reimbursement: CMS Explains How to Get ADLT Status for New Lab Tests
June 11, 2018
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new PAMA Part B payment rules for lab tests remains a work in progress. On March … [Read more...]
COMPLIANCE
Medicaid Fraud: Enforcement Continues to Trend Down as Labs Drift Deeper into the Background
May 22, 2018
Last month, the OIG published its annual summary of Medicaid Fraud Control Unit (MCFU) activity for FY 2017. Here is a summary of the key findings, trends and impact on labs. Background The 50 MCFUs … [Read more...]
