News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel

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Clinical Laboratories and Pathology Groups
Hosted by Robert Michel
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From Regulations to Innovations: Annual Executive War College Convenes in New Orleans

Apr 29, 2024 | International Laboratory News, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Resources, Management & Operations, Pathology and Clinical Laboratory Conferences

29th Conference Features Information on What Clinical Lab Leaders Need to Know About a ‘Perfect Storm’ of New Compliance Challenges

There are signs that the US Food and Drug Administration (FDA) is poised to release the final rule on laboratory developed tests (LDTs)—perhaps even during the 29th annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management, which kicks off in New Orleans this week.

The Office of Management and Budget (OMB) concluded its review of the final rule on April 22. Former FDA commissioner Scott Gottlieb, MD, and other regulatory experts expect the White House to send the final rule to Congress as early as late April and no later than May 22.

Either way, Tim Stenzel, MD, PhD, former director of the FDA’s Office of In Vitro Diagnostics, and other regulatory experts will be on hand at Executive War College (EWC) to walk attendees through what promises to be a “perfect storm of clinical lab and pathology practice regulatory changes.” Stenzel is scheduled to speak about the LDT rule during three sessions with fellow panelists on Day 1.

On Tuesday morning, Lâle White, executive chair and CEO of San Diego’s XiFin, Inc., will present a keynote on new regulations and diagnostics players that are “poised to reshape lab testing.” Her presentation is followed by a general session on Clinical Laboratory Improvement Amendments (CLIA) regulations featuring Salerno Reynolds, PhD., acting director at the U.S. Centers for Disease Control and Prevention (CDC) Center for Laboratory Systems and Response.

Robert Michel, Editor-in-Chief of The Dark Report will wrap day one with a general session on the regulatory trifecta coming soon to all labs, from LDT to CLIA to private payers’ policies for genetic claims.


Innovation in the spotlight

“It’s a rich mix of expert speakers, lab leaders who are doing innovative things in their own organizations, along with the consultants and the lab vendors who are pushing the front edge of laboratory management, operations, and clinical service delivery,” says Michel, who each year creates the agenda for EWC.

Several sessions, master classes, and speakers will look to the future with discussions about how healthcare data drives innovations in diagnostics and patient care, digital pathology adoption around the world, and hot topics such as artificial intelligence (AI), big data and precision medicine.

Panels offer a variety of viewpoints

“One valuable benefit of participating at the Executive War College is the various panel discussions,” Michel says. “Each panel brings together national experts in a specific area of the laboratory profession. As an example, our lab legal panel this year brings together four prominent and experienced attorneys who share opinions, insights, and commentary about relevant issues in compliance, regulations, and contractual issues with health plans and others.”

This allows attendees to experience a breadth of opinions from multiple respected experts in this area, he adds.

For example, a digital pathology panel will bring together representatives from labs, service providers, and the consultants that are helping labs implement digital pathology. The session will be especially helpful to labs that are deciding when to acquire digital pathology tools and how to deploy them effectively to improve diagnostic accuracy, Michel says.

And a managed care panel will feature executives from some of the nation’s biggest health plans—the ones that sit on the other side of the table from labs—to provide insights and guidance on how labs can work more effectively with them.

Networking opportunities abound

The event is about much more than politics and policy, however. There’s also a distinct social aspect.

“This is a friendly tribe,” Vicki DiFrancesco, a US HealthTek advisory board member who first attended EWC more than two decades ago, wrote in a recent post.

“Everyone is welcome, and everyone appreciates the camaraderie, so don’t be shy about going up and introducing yourself to someone. The quality of the crowd is top-notch, yet I’ve always experienced a willingness for those of us who have been to this rodeo to always be welcoming,” she notes.

Michel agrees. “One of the special benefits of participation at the EWC is the superb networking interactions and collaboration that takes place,” he says.

 “From the first moments that attendees walk into our opening reception on Monday night until the close of the optional workshops on Thursday, one can see a rich exchange happening amongst circles of attendees. Introductions are being made. Connections are developing into business opportunities. The sum of an attendee’s experience at the Executive War College is to gain as much knowledge from the networking and collaboration as they do from the sessions.”

–Gienna Shaw

Preparing Clinical Laboratories for Invasive Federal Enforcement of Fraud and Abuse Laws, Increased Scrutiny by Private Payers, New Education Audits, and More

Nov 13, 2019 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Medical laboratory leaders need to take opportunities to stay abreast of government and payer activity, particularly as payer audits become tougher, say legal experts

Even compliant clinical laboratories and anatomic pathology groups are reporting tougher audits and closer scrutiny of the medical lab test claims they submit for payment. This is an unwelcome development at a time when falling lab test prices, narrowing networks, and more prior-authorization requirements are already making it tough for labs to get paid for the tests they perform.

Clinical laboratory leaders can expect continued scrutiny of their labs’ operations and financials as government and commercial payers move forward with invasive programs and policies designed to ferret out fraud and bad actors.

Federal officials are focusing their investigations on healthcare providers who mismanage or inappropriately use Medicare and Medicaid programs, while commercial payers are closely scrutinizing areas such as genetic testing prior authorization, say healthcare attorneys with Cleveland Ohio-based McDonald Hopkins, LLC.

“The government is looking at fraud, waste, and abuse, and all the different ways they come into play,” said Elizabeth Sullivan, Esq., a Member and Co-Chair of the firm’s Healthcare Practice Group, in an exclusive interview with Dark Daily. “We anticipate there will be more enforcement [of fraud and abuse laws] centered around different issues—anything that can be a false claim.”

Specifically, government officials will key in on violations of the Stark Law, EKRA (the Eliminating Kickback in Recovery Act of 2018), and other anti-kickback statutes and laws, Sullivan said.

“And clinical laboratories, by virtue of the type of services and service arrangements they offer, will continue to be a target,” she added.

Medical laboratory leaders also must prepare for aggressive tactics by insurance companies. “On the commercial side, payers are getting more aggressive and more willing to take things to ligation if they don’t get what they want and don’t see a settlement that satisfies their concerns over issues,” said Courtney Tito, Esq., also a Member with McDonald Hopkins, in the Dark Daily interview. 

Current Investigations Likely to Impact Clinical Laboratories

Sullivan and Tito advise clinical labs to be aware of the following issues being fast-tracked by government and private payers:

The TPE audits program, according to CMS, is focused on providers with high claim error rates or unusual billing practices. During a TPE, a Medicare administrative contractor (MAC) works with a provider to identify and correct errors.

“The TPE audits are real hot right now. We are seeing a lot of clients go through this,” Tito said.

Feds Crack Down on Genetic Testing Fraud Schemes

Genetic testing is another “hot button” issue for enforcement by government and private payers, Sullivan and Tito state.

In fact, the US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) in September announced charges against 35 people including nine physicians for allegedly participating in healthcare fraud schemes involving genetic cancer testing of seniors nationwide, states a DOJ news release.

CMS is taking action against testing companies and practitioners who submitted more than $1.7 billion in claims to Medicare, the statement added.

The scheme involved medical laboratories conducting the genetic tests, McDonald Hopkins noted in an Alert about the DOJ investigation. The alert described how the scam operated:

  • Scam recruiters approached Medicare beneficiaries at health fairs;
  • In exchange for a DNA sample (in the form of a cheek swab) and a copy of the victim’s driver’s license, the “representative” offered a free genetic test;
  • Representatives allegedly asked the seniors’ doctors to sign-off on test orders. If the seniors’ physicians refused, the scammers offered kickbacks to doctors already in their group;
  • Clinical laboratories that performed the tests were reimbursed from Medicare and, allegedly, shared the proceeds with the scammers.

“Although these opportunities may seem appealing as an additional revenue source for providers, it is always important to review the regulatory requirements as well as the potential anti-kickback statute and Stark implications for any new arrangement,” Sullivan and Tito wrote in the McDonald Hopkins Alert article. 

Criminal Behavior in CMS Programs

Effective Nov. 4, 2019, CMS issued a final rule intended to stop fraud before it happens by keeping “unscrupulous providers” out of the federal healthcare programs in the first place, states a CMS news release.

The rule (CMS-6058-FC), called “Program Integrity Enhancements to the Provider Enrollment Process,” has new revocation and denial authorities to stop waste, fraud, and abuse, the news release points out.

Reasons CMS can revoke or deny enrollment to providers, according to another McDonald Hopkins Alert, include:

  • Outstanding debt to CMS following overpayment to the provider;
  • Coming back into CMS programs with a new identity;
  • Billing for services from non-compliant locations;
  • Abusive ordering or certifying under Medicare Part A or Medicare Part B.

Additionally, EKRA establishes “criminal penalties for unlawful payments for referrals to recovery homes and clinical treatment facilities,” Dark Daily recently reported. However, as the e-briefing points out, it is unclear whether EKRA applies to clinical laboratories.

Nevertheless, Sullivan points out that, “Even without EKRA, the anti-kickback statute applies to any arrangement between individuals. And, it is good to have an attorney look at those arrangements. What your sales reps are doing in the field, how they are communicating, and their practices warrant oversight. EKRA just makes it all the more important.”

During an upcoming Dark Daily webinar, attorneys Elizabeth Sullivan (left) and Courtney Tito (right) of McDonald Hopkins, LLC, will advise clinical laboratory leaders and financial staff on how to prepare for future aggressive payer audits, rigid enforcement of fraud and abuse laws, and more. (Photos copyright: LinkedIn/Dark Daily.)

Clinical Laboratories Need Compliance Plan, Focus on Payers

With so many legal requirements and payer programs, Sullivan advises medical labs and pathology group practices to work with resources they trust and to have a compliance plan at the ready. “Have resources in place, including but not limited to a compliance officer, a committee, and someone who is spending time on these issues. Monitoring government enforcement and payer activity is the most critical,” she said.

To assist labs in remaining fully informed on these critical compliance topics, and the federal government’s latest legislation to combat fraud, Dark Daily is offering a webinar on November 20th at 1pm Eastern time. Sullivan and Tito will offer their insights and advice on how labs should prepare for CMS’ battle to reign in fraud and commercial payers’ increased scrutiny into prior authorizations.

Clinical laboratory leaders, compliance officers, and finance staff will benefit greatly from this crucial resource.

Register for “Bracing for Aggressive Payer Audits, Rigid Enforcement of Fraud and Abuse Laws, and More” at https://www.darkdaily.com/product/payor-audits-webinar/ or by calling 512-264-7103.

—Donna Marie Pocius

Related Information:

Dark Daily Webinar: What Lab Leaders Need to Know About How to Prepare for 2020: Bracing for Aggressive Payer Audits, Rigid Enforcement of Fraud and Abuse Laws, and More

Federal Law Enforcement Action Involving Fraudulent Genetic Testing Results in Charges Against 35 Individuals Responsible for Over $2.1 Billion in Losses is One of the Largest Healthcare Fraud Schemes Ever Charged

OIG Focusing on Laboratories Involved in Genetic Testing Scams

CMS Announces New Enforcement Authorities Reduce Criminal Behavior in Medicare, Medicaid, and CHIP

CMS Aims to Combat Criminal Behavior Through Enrollment Process

Does New Opioid Law Require Clinical Laboratories to Change How They Pay Sales Employees?

Good News for Clinical Pathology Laboratories: Medicare Officials Intend to Rescind Rule Requiring Physician Signatures on Paper Lab Reqs

Feb 14, 2011 | Compliance, Legal, and Malpractice, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement


CMS says it will take steps to rescind the final rule before its scheduled implementation on April 1, 2011

Clinical laboratories and pathology groups will welcome the news that the federal Centers for Medicare & Medicaid Services (CMS) will take steps to rescind the final rule that requires the physician’s signature be on all paper requisitions for medical laboratory tests ordered on behalf of Medicare patients. It means that implementation of the rule—now scheduled to become effective on April 1, 2011—will not happen if CMS officials act in a timely manner.

Dark Daily has learned that last Friday a conference call took place involving Jonathan Blum, Director of the Center for Medicare Management, and representatives from the American Association of Bioanalysts (AAB) and the American Clinical Laboratory Association (ACLA). During the conference call, Blum disclosed that a decision had been reached within CMS to rescind the final rule that would require physicians’ signatures on paper requisitions for medical laboratory tests. Apparently, CMS intends to take the steps necessary to rescind this final rule before its effective date of April 1, 2011.
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CLIA Inspections of Clinical Pathology Laboratories Appear to Be Tougher on Loosely-Managed Labs

Oct 22, 2010 | Laboratory News, Laboratory Pathology, News From Dark Daily

Pathologists and medical laboratory managers should be alert to compliance changes


CLIA inspections of medical laboratories may be getting more rigorous in certain areas of laboratory operations, according to anecdotal information emerging from the field. Clinical laboratory management consulting firms report that they are experiencing an increased number requests for help from hospitals following a recent CLIA inspection of their laboratories.

Laboratory management consultants tell Dark Daily that, for the most part, well-run medical laboratories are having few problems when CLIA inspectors show up on site. Because these laboratories are diligent about compliance with legal requirements, the CLIA inspection seldom turns up a serious deficiency nor identifies a major compliance failure within the laboratory.

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HITECH ACT Mandates New Patient Privacy Requirements on Labs and Pathology Groups

Oct 22, 2009 | Laboratory News, Laboratory Pathology

Labs Must Report Privacy Breaches of 500 or More to the Media

Call it HITECH collides with HIPAA! Most pathologists and lab executives know that passage of the HITECH Act was the part of 2009’s American Recovery and Reinvestment Act (also referred to as “ARRA” or the “stimulus bill”). HITECH provides incentives for the expanded use of electronic health records by physicians and other providers.

But what is lesser known is how the HITECH Act creates new legal obligations of covered entities and business associates under the Health Insurance Portability and Accountability Act of 1996 (HIPPA). These new legal mandates are designed to protect the privacy and security of the patient. They require clinical laboratories and all providers to take specific actions whenever patient privacy is breached.
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