March 2023
Full Focus: Complying with EKRA Following Recent Legal Action

Are you confident your lab's compensation arrangements for sales and marketing employees are compliant with the Eliminating Kickbacks in Recovery Act (EKRA) following recent legal action? Join us at 12:00 p.m. EDT, March 22, for our upcoming webinar to hear from Charles Dunham, a corporate healthcare attorney at Greenberg Traurig, LLP, whose firm is working on an appeal of a recent EKRA prosecution, for an update on how labs can comply with the law as it currently stands.

During this webinar, we will discuss:
  • A brief history of EKRA.
  • An overview of arrangements barred under EKRA.
  • Updates on EKRA case law and prosecutions to date.
  • Alternative compensation strategies under EKRA for sales personnel. 
1. Major COVID Testing Changes Expected When Health Emergency Ends May 11

While labs and providers performing COVID testing have long anticipated the expiration of testing flexibilities, it’s still crucial they understand how billing and administrative practices that have become commonplace during the past two-plus years must be amended to ensure their testing continues to be reimbursed and compliant.

2. Guide: How to Apply for a CMS-116 Certificate

Are you thinking about opening a clinical laboratory? If you’ve identified your test menu, instrumentation, and have hired a Laboratory Director, you’re now ready to obtain a CLIA certificate. Check out the updated guide below for a detailed walkthrough of everything you need to know to complete this process!

3. Clinical Labs Still Face Staffing Issues as COVID Declines

The immense focus on COVID testing over a period of years led a number of young professionals to enter the workforce with a skillset focused on molecular testing, which is now limiting their opportunities as labs seek to hire for other sub-specialties. This, combined with an aging workforce and an ongoing significant demand for laboratory services, continues to lead to an overall shortage of medical lab professionals.

4. Stay Up to Date on the Latest Industry News and Changes

Follow Lighthouse on LinkedIn to stay current on the latest news and happenings impacting clinical lab professionals. You'll also receive real-time notifications about our latest webinars and other educational content.

1. UnitedHealthcare Clamping Down on Expanded Carrier Screening, Genetic Counselors

Despite the fact that expanded genetic carrier screening panels have been increasingly embraced by professional organizations and clinicians in recent years, getting private payer coverage for these tests continues to be a significant hurdle.

In a recent interview with 360Dx, Lighthouse's Ann Lambrix and a host of other industry experts weigh in on this trend and discuss why payers may be wary of the increased utilization of these panels.

2. CMS Announces Ongoing MIPS Audits

Are you confident in the accuracy of your recent Merit-based Incentive Payment Program (MIPS) submissions? CMS recently announced the agency has contracted with a third-party auditor to validate data submissions for the 2019, 2020, and 2021 performance years. 
Groups who have errors identified in their submissions could be subject to takebacks or future penalties to their Medicare Part B payments.

The overall Quality Payment Program (QPP) continues to grow more complex each year, so if you're still struggling with your submissions, now is the time to ensure you have a strong reporting plan moving forward!
3. OIG Identifies Definitive Drug Testing as Area of Concern for Noncompliant Payments

During a recent audit of definitive drug testing services conducted by the Office of the Inspector General (Jan. 2016 to Dec. 2020), it was determined Medicare paid $704.2 million for services that were at risk for noncompliance with Medicare requirements. These payments were for the definitive drug testing code with the highest reimbursement amount (G0483, 22 or more drug classes). The payments were made to 1,062 providers deemed to be "at-risk" who routinely billed G0483 when it may not have been necessary.

Given this development, it's safe to say toxicology labs should expect to see definitive drug testing targeted as an area of concern for future audits.
Deep Dive: Why Clinical Labs Must Prepare for Value-Based Care
As clinical laboratories continue to evolve to adapt to new innovations and approaches to patient care, one change the industry has been slow to fully embrace is the advent of value-based care and how it will impact laboratory medicine.

With the majority of Medicare payments predicted by many experts to be fully value-based by 2030, some clinical lab stakeholders have been working to raise awareness about the industry’s need to have a seat at the table as these changes take place to ensure labs are viewed as a partner as opposed to a commodity in the patient care process.
Khosrow Shotorbani
“We believe, simply, past does not represent the future. In order to be relevant (clinical labs) really need to reimagine the future and quantify attributes in a future state that align with the changes in healthcare.”

-- Khosrow Shotorbani, MBA, MT (ASCP), President and Executive Director of Project Santa Fe (Clinical Lab 2.0)
1. Executive War College on Diagnostics, Clinical Lab, and Pathology Management

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The Lab Insighter is a monthly publication for Lab Owners and Decision Makers.