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...]
FALSE CLAIMS
Enforcement Trends: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests
May 7, 2018
While the federal enforcement community has made urine drug testing of opioid drug patients its number one target for lab-related False Claims Act (FCA) charges for the time being, nuclear stress … [Read more...]
COMPLIANCE
Physician Referrals: New Rules Offer Some Stark Law Relief but Not Nearly Enough
April 11, 2018
Like most budget bills, the new federal Bipartisan Budget Act of 2018 includes a number of changes to Medicare fraud and enforcement requirements. One set of changes affects the current physician … [Read more...]
FOCUS ON
New Laws: Very Quietly, Congress Doubles Penalties for Medicare Fraud & Abuse
April 10, 2018
Sneaky may be too strong a word. But what is fair to say is that the new hikes in federal health care fraud violation penalties have flown totally under the radar despite their obvious and immediate … [Read more...]
FOCUS ON
DOJ to Prosecutors: Show Tough Love to Whistleblowers with Weak Cases
March 19, 2018
A newly leaked internal Justice Department memo signals a new prosecution policy that may make it harder for whistleblowers to bring qui tam whistleblower lawsuits under the False Claims Act (FCA). … [Read more...]
COMPLIANCE
Case of Month: Judge Takes Back Ruling that Labs Must Independently Verify Medical Necessity
January 22, 2018
Thanks for clearing that up. As if the lab industry doesn't already have enough legal agita to deal with, last June a federal D.C. District Court upheld a whistleblower's right to sue Boston Heart … [Read more...]
FOCUS ON
CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
January 16, 2018
"May you live in interesting times." If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very … [Read more...]
LEGISLATION
Cybersecurity: New Bill Would Make Lab Employees Criminally Liable for Concealing Data Breaches
December 12, 2017
While massive data breaches have existed as long as massive data itself, legal accountability for organizations that commit them is a relatively recent phenomenon. Breach Liability of Labs Because … [Read more...]
PRECISION MEDICINE
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
December 12, 2017
Using Nuclear Stress Tests as Screening Procedure = Medical Necessity Violation Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing … [Read more...]
