On Sept. 17, the Centers for Medicare & Medicaid Services (CMS) announced that it’s delaying an interoperability rule governing how payors are expected to exchange with one another. However, the … [Read more...]
Interoperability
CMS Delays Payer-to-Payer Data Exchange but Prior Authorization Rules Remain on Track
September 23, 2021
FDA
FDA Hikes Premarket Application User Fees by 2.5 Percent
September 23, 2021
Applying for FDA premarket review of medical devices will be more expensive next year. On August 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]
Compliance Alert
OIG Calls on CMS to Recover Phlebotomy Travel Allowance Overpayments
September 23, 2021
If your lab bills Medicare for phlebotomy travel allowances, a Medicare Administrative Contractor (MAC) claims audit may be in your future. The threat stems from a new Office of Inspector General … [Read more...]
Reimbursement
Biden Pulls Plug on Automatic Medicare Coverage for MCIT “Breakthrough” Devices
September 23, 2021
In a reminder of why politics and presidential elections matter so much, the Biden administration announced that it’s scrapping a Trump regulation that would have automatically provided initial … [Read more...]
Independent Labs
CMS Clarifies IDTF Billing, Coding and Coverage Rules
September 23, 2021
In September, the Centers for Medicare & Medicaid Services (CMS) issued new guidance making some important clarifications on Independent Diagnostic Testing Facility (IDTF) billing requirements. … [Read more...]
Labs in Court
Medical Group Pays $94.4K to Settle HDL Process and Handling Payment Anti-Kickback Law Charges
September 23, 2021
Case: A physician and his Texas medical group have agreed to fork over $94,440 to the OIG for accepting kickbacks from now defunct Health Diagnostic Laboratory, Inc. (HDL) in the form of processing … [Read more...]
COVID-19
White House Rolls Out Plan to Increase Nationwide Rapid, Point-of-Care COVID-19 Testing
September 21, 2021
Much has changed since the spring when Abbott, LabCorp, Quest and other major COVID-19 testing labs were demobilizing their coronavirus infrastructure and pivoting to normal business. The surge of new … [Read more...]
Labs in Court
Use of Hospital’s NPI Enough to Establish Testing Labs’ Liability for Pass Through Billing
September 14, 2021
Case: Licensees of Blue Cross and Blue Shield Association sued individuals and entities allegedly involved in a pass-through scheme for toxicology and blood tests billed from a small rural hospital in … [Read more...]
FDA Watch
Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
September 13, 2021
On Aug. 2, 2021, the FDA published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here’s a quick briefing of the new rules, which took effect on … [Read more...]
M&A Report
Illumina Makes Audacious Move by Completing Grail Acquisition Without Regulatory Approval
September 13, 2021
It’s damn the torpedoes and full speed ahead for Illumina. Recognizing that it had no chance of securing the necessary regulatory approval in time to make the hard closing deadline and staring a $300 … [Read more...]
