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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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COVID-19 Testing Reimbursement Scrutiny is Coming for Clinical Laboratories, Attorneys Predict at Executive War College

Investigators may look into various angles, including drive-through testing sites for COVID-19 and whether uninsured patients were verified before free tests

Three healthcare compliance attorneys gave a clear and concise message to clinical laboratory managers and pathologists at the 2022 Executive War College Conference on Laboratory and Pathology and Management: Expect the government to scrutinize reimbursements it paid for COVID-19 testing, particularly for testing conducted at drive-through sites that popped up all over the country.

“The important question is: What is the fair market value of those specimens?” noted attorney Emily Johnson, JD, a Member at law firm McDonald Hopkins in Chicago. Johnson spoke during a legal panel on Wednesday at the Executive War College in New Orleans.

The panel spent 75 minutes discussing various legal concerns, many of them related to COVID-19 testing, before a crowd of about 80 attendees.

Attorney Emily Johnson, JD, of Chicago law firm McDonald Hopkins explained possible COVID-19 test fraud enforcement to attendees at the 2022 Executive War College. (Photo copyright: The Dark Intelligence Group.)

Audits May Be Coming of HRSA Reimbursements for COVID-19 Testing

Consumer Reports noted in a January article that COVID-19 testing prices varied wildly both in traditional healthcare settings and popup sites—in some cases, exceeding $1,400.

The average price for such a test within an insurance company’s network was $130.

Some people paid for those tests out of pocket or got them covered by insurance. For uninsured patients, the federal Health Resources and Services Administration (HRSA) established a pool of money to reimburse labs for free COVID-19 tests. That pool recently dried up and Congress has not approved more funding.

The U.S. Department of Justice may investigate the uninsured aspect of claims—specifically, whether there were attempts by laboratory staff members to verify whether a patient truly was not covered by health insurance, explained Karen Lovitch, JD, Chair of the Health Law and Healthcare Enforcement Defense Practice at law firm Mintz in Washington.

These issues bring up False Claims Act risks, especially if a clinical laboratory audits its own COVID-19 test claims. “If labs go back retroactively and determine a claim was paid that shouldn’t have been paid, those labs must absolutely be prepared to return that money,” Lovitch warned.

Clinical Laboratories Need a Business Plan for Post-COVID-19 Testing

Related to HRSA payments ending for COVID-19 testing of uninsured payments, clinical laboratories should be wary about outright ending such testing without a documented business plan demonstrating the rationale for doing so, Johnson noted. That advice is relevant for labs and pathology groups that received financial assistance from HRSA’s Provider Relief Fund during the pandemic.

Some have interpreted information about the fund to mean providers are obligated to treat uninsured patients, Johnson added.

“If I stop accepting uninsured patients for COVID testing, am I in violation of the Provider Relief Fund?” she asked. A clearly documented reason for doing so, such as a need to keep the business afloat through paid testing, would be a first step for concerned medical laboratories to take, she added.

Another point for labs to ponder: In March, the federal government named Kevin Chambers, JD—who is currently Associate Deputy Attorney General at the DOJ—as the first Director of COVID-19 Fraud Enforcement.

That appointment emphasizes the government’s commitment to undercovering SARS-CoV-2 wrongdoing, said attorney David Gee, JD, a Partner at law firm Davis Wright Tremaine in Seattle. Gee rounded out the panel at the Executive War College.

“I guarantee Chambers’ bosses want him to demonstrate the government is serious about COVID-19 fraud,” Gee commented.

EKRA Becomes New Tool against COVID-19 Fraud

Finally, as Dark Daily previously reported, the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is sometimes being used to prosecute cases of alleged COVID-19 testing fraud.

EKRA has generally been associated with rules against paying clinical laboratory sales reps a commission based on testing volumes they generate. However, Johnson predicted more EKRA cases will be filed related to alleged kickbacks paid in return for referrals for COVID-19 testing.

“Prosecutors seem willing to go after these cases aggressively,” she added.

And in The Dark Report’s upcoming Regulatory Update, “Dept. of Justice: EKRA Governs Lab Sales and Marketing Commissions,” Dark Daily’s sister publication covers how a recent ruling by a federal judge may weaken EKRA and “immunize conduct that drives up medical costs.”

Subscribers to The Dark Report will want to stay informed on critical changes taking place that affect how EKRA operates.

—Scott Wallask

Related Information:

Keynote Speakers at the Executive War College Describe the Divergent Paths of Clinical Laboratory Testing

Your Questions About Home COVID-19 Tests, Answered

DOJ: Combatting COVID-19 Fraud

On-Demand Webinar: What Lab Leaders Need to Know: Data Security Agreements, Surprise Billing, EKRA, AKS, CURES Act, and More

EKRA Now Used to Combat Fraudulent COVID-19 Testing, Too

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Comprehensive Laboratory and Laboratory-related Accreditation Services and Training


Corporate Address
American Association for Laboratory Accreditation (A2LA)
5301 Buckeystown Pike, Suite 350
Frederick, MD 21704
Phone: 301-644-3248
Fax: 240-454-9449

 With A2LA’s “Deemed Status” by the Centers for Medicare and Medicaid Services (CMS), A2LA now offers three accreditation programs to meet the needs of the clinical laboratory community (see below for more information about each):

• The PLATINUM CHOICE Clinical Accreditation Program;

• The CLIA Accreditation Program; and

• The ISO 15189: 2012 Accreditation Program

Accreditation within A2LA’s Platinum Choice program sets a clinical laboratory apart from its competitors and counterparts as it is the only program in the world that offers domestically-recognized accreditation to the CLIA requirements as well as internationally-recognized accreditation to ISO 15189:2012.

A2LA provides accreditation to any clinical laboratory performing moderate or high complexity testing as defined in 42CFR493. Laboratories that provide only waived or Provider Performed Microscopy (PPM are not eligible for accreditation through A2LA; however, if a laboratory performs moderate or high complexity testing along with waived testing and/or PPM, A2LA will accredit the laboratory for all of this testing and microscopy.

On August 7, 2014, CMS approved A2LA’s new approach toward assessing and accrediting clinical laboratories that perform waived testing. Such testing will be held to the CLIA requreiements for waived testing as well as requirements that A2LA has adopted from CDC guidelines.

A2LA offers accreditation to clinical testing laboratories in the following specialties and subspecialties:

• Histocompatibility
• Microbiology
• Bacteriology
• Mycobacteriology
• Mycology
• Parasitology
• Virology
• Diagnostic Immunology
• Syphilis Serology
• General Immunology
• Chemistry
• Routine Chemistry
• Special Chemistry
• Urinalysis
• Endocrinology
• Toxicology
• Clinical Cytogenetics
• Flow Cytometry
• Hematology
• General Hematology
• Coagulation
• Immunohematology
• ABO Group
• Antibody Detection (transfusion)
• Antibody Detection (non-transfusion)
• Antibody Identification
• Compatibility Testing
• Rh Type
• Pathology
• Histopathology
• Oral Pathology
• Cytology
• Molecular Pathology
• Radiobioassay


A2LA offers three options for clinical laboratory accreditation and the requirements for each differ, as indicated below. Please click on each of the options listed for more information about the specific accreditation program and its requirements.

• PLATINUM CHOICE Clinical Accreditation Program – A2LA refers to this program as the “Platinum Choice” since all laboratories applying within this program are assessed against both ISO 15189:2012 and the 42CFR493 standard (the “CLIA requirements”) with one assessment and one team of assessors. Accreditation within this program sets a clinical laboratory apart from its competitors and counterparts as it is the only program in the world that offers domestically-recognized accreditation to the CLIA requirements as well as internationally-recognized accreditation to ISO 15189:2012.

• CLIA Accreditation Program – Laboratories applying within this program are assessed against the requirements found within 42CFR493 – Centers for Medicare & Medicaid Services, Department of Health and Human Services, Standards and Certification, Laboratory Requirements (the “CLIA requirements”).

• ISO 15189:2012 Accreditation Program – Laboratories applying within this program are assessed against the general criteria contained within ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence.

Click on each of the programs above to learn more about each particular option.

Interested in learning how A2LA accreditation may be accepted internationally as well as domestically by federal, state and private sector entities? Click on the following links for more information:
• A2LA’s International Recognitions
 A2LA’s Domestic Recognitions


A2LA has developed a Medical Testing Advisory Committee (MedTAC) to assist the Association by providing technical input on policy creation and decisions related to the clinical testing laboratory accreditation program. If you wish to participate on the MedTAC, we invite you to contact Roxanne Robinson, A2LA Vice President/COO, at


• Amanda McDonald
Accreditation Officer II

• Roxanne Robinson
Vice President/.COO

• ISO 15189 Medical FAQ
• Branch System Policy