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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Federal EKRA Law Continues to Cause Uncertainty in Clinical Laboratory Sales Compliance

Healthcare attorneys advise medical laboratory leaders to ensure staff understand difference between EKRA and other federal fraud laws, such as the Anti-kickback Statute

More than four years have passed since Congress passed the law and yet the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) continues to cause anxiety and confusion. In particular are the differences in the safe harbors between the federal Anti-Kickback Statute (AKS) and Stark Law versus EKRA. This creates uncertainty among clinical laboratory leaders as they try to understand how these disparate federal laws affect business referrals for medical testing.

According to a news alert from Tampa Bay, Florida-based law firm, Holland and Knight, “EKRA was enacted as part of comprehensive legislation designed to address the opioid crisis and fraudulent practices occurring in the sober home industry.” However, “In the four years since EKRA’s enactment, US Department of Justice (DOJ) enforcement actions have broadened EKRA’s scope beyond reducing fraud in the addiction treatment industry to include all clinical laboratory activities, including COVID-19 testing.”

It is important that medical laboratory leaders understand this law. New cases are showing up and it would be wise for clinical laboratory managers to review their EKRA/AKS/Stark Law compliance with their legal counsels.

David Gee

“Keeping in mind that [EKRA is] a criminal statute, clinical laboratories need to take steps to demonstrate that they’re not intending to break the law,” said attorney David Gee, a partner at Davis Wright Tremaine, in an exclusive interview with The Dark Report. “[Lab leaders should] think about what they can do to make their sales compensation program avoid the things the government has had such a problem with, even if they’re not sure exactly how to compensate under the language of EKRA or how they’re supposed to develop a useful incentive compensation plan when they can’t pay commissions.” David Gee will be speaking about laboratory regulations and compliance at the upcoming Executive War College in New Orleans on April 25-26, 2023. (Photo copyright: Davis Wright Tremaine.)

How Does EKRA Affect Clinical Laboratories?

The federal EKRA statute—originally enacted to address healthcare fraud in addiction treatment facilities—was “expansively drafted to also apply to clinical laboratories,” according to New York-based law firm, Epstein Becker and Green. As such, EKRA “applies to improper referrals for any ‘service,’ regardless of the payor. … public as well as private insurance plans, and even self-pay patients, fall within the reach of the statute.”

In “Revised Stark Law, Anti-Kickback Statute Rules Are Good News for Labs,” Dark Daily’s sister publication The Dark Report noted that EKRA creates criminal penalties for any individual who solicits or receives any remuneration for referring a patient to a recovery home, clinical treatment facility, or clinical laboratory, or who pays or offers any remuneration to induce a referral.

According to Epstein Becker and Green, EKRA:

  • Applies to clinical laboratories, not just toxicology labs.
  • Has relevance to all payers: Medicare, Medicaid, private insurance plans, and self-pay.
  • Is a criminal statute with “extreme penalties” such as 10 years in prison and $200,000 fine per occurrence.
  • Exceptions are not concurrent with AKS.
  • Areas being scrutinized include COVID-19 testing, toxicology, allergy, cardiac, and genetic tests.

“For many clinical laboratories, a single enforcement action could have a disastrous effect on their business. And unlike other healthcare fraud and abuse statutes, such as the AKA, exceptions are very limited,” Epstein Becker and Green legal experts noted.

“Therefore, a lab could potentially find itself protected under an AKS safe harbor and still potentially be in violation of EKRA,” they continued. “The US Department of Health and Human Services (HHS) and the DOJ have not provided any clarity regarding this statute (EKRA). Without this much needed guidance clinical laboratories have been left wondering what they need to do to avoid liability.”

EKRA versus AKS and Stark Law

HHS compared AKS and the Stark Law (but not EKRA) by noting on its website prohibition, penalties, exceptions, and applicable federal healthcare programs for each federal law: 

  • AKS has criminal fines of up to $25,000 per violation and up to a five-year prison term, as well as civil penalties.
  • The Stark Law has civil penalties only.
  • AKS prohibits anyone from “offering, paying, soliciting, or receiving anything of value to induce or reward referrals or generate federal healthcare program business.”
  • The Stark Law addresses referrals from physicians and prohibits the doctors “from referring Medicare patients for designated health services to an entity with which the physician has a financial relationship.”

EKRA is more restrictive than AKS, as it prohibits some compensation that AKS allows, healthcare attorney Emily Johnson of McDonald Hopkins in Chicago told The Dark Report.

“Specifically, AKS includes a safe harbor for bona fide employees that gives an employer wide discretion in how employees are paid, including permitting percentage-based compensation,” Johnson wrote in a Dark Daily Coding, Billing, and Collections Special Report, titled, “Getting Paid for COVID-19 Test Claims: What Every Clinical Lab Needs to Know to Maximize Collected Dollars.”  

EKRA Cases May Inform Clinical Laboratory Leaders

Recent enforcement actions may help lab leaders better understand EKRA’s reach. According to Holland and Knight:

  • Malena Lepetich of Belle Isle, Louisiana, owner and CEO of MedLogic LLC in Baton Rouge, was indicted in a $15 million healthcare fraud scheme for “allegedly offering to pay kickbacks for COVID-19 specimens and respiratory pathogen testing.”
  • In S-G Labs Hawaii, LLC v. Graves, a federal court concluded the laboratory recruiter’s contract “did not violate EKRA because the recruiter was not referring individual patients but rather marketing to doctors. According to the court, EKRA only prohibits percentage-based compensation to marketers based on direct patient referrals.”
  • In another federal case, United States v. Mark Schena, the court’s rule on prohibition of direct and indirect referrals of patients to clinical labs sent a strong signal “that EKRA most likely prohibits clinical laboratories from paying their marketers percentage-based compensation, regardless of whether the marketer targets doctors or prospective patients.”

What can medical laboratory leaders do to ensure compliance with the EKRA law?

In EKRA Compliance, Law and Regulations for 2023, Dallas law firm Oberheiden P.C., advised clinical laboratories (as well as recovery homes and clinical treatment facilities) to have EKRA policies and procedure in place, and to reach out to staff (employed and contracted) to build awareness of statute prohibitions and risks of non-compliance.

One other useful resource for clinical laboratory executives and pathologists with management oversight of their labs’ marketing and sales programs is the upcoming Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. The conference takes place on April 25-26, 2023, at the Hyatt Regency in New Orleans. A panel of attorneys with deep experience in lab law and compliance will discuss issues associated with EKRA, the Anti-Kickback Statutes, and the Stark self-referral law. 

Donna Marie Pocius

Related Information:

The State of EKRA

Four Years After EKRA: Reminders for Clinical Laboratories

Revised Stark Law and AKS Rules Are Good News for Labs

Comparison of the Anti-Kickback Statute and Stark Law

Getting Paid for COVID-19 Test Claims: What Every Clinical Lab Needs to Know to Maximize Collected Dollars

EKRA Compliance, Law and Regulations for 2023

Nearly One Million Patient Records of Hospitals, Health Clinics, Medical Laboratories, and other Providers Stolen in Ransomware Attack on Medical Records Company

Clinical labs should proactively investigate how a vendor will respond to a data security incident and how quickly, says expert

Clinical laboratory managers in New York and surrounding areas should be aware that  almost one million protected health information (PHI) records from as many as 28 healthcare providers appear to have been stolen from a medical records company that services these providers.

Practice Resources LLC (PRL), a company that provides billing services for dozens of hospitals and medical providers in Central New York, announced in August they were the target of a ransomware attack that occurred on April 12 of this year. The Syracuse-based organization stated that hackers may have captured personally identifiable information (PII) such as names, home addresses, treatment dates, health plan numbers, and internal account numbers of 934,138 patients.

The data breach affected the patient records of dozens of medical providers and the clinical laboratories that service them, as well as physical therapists, pediatricians, gynecologists, orthopedic surgeons, and more.

Dark Daily’s sister publication The Dark Report covered a similar 2019 data breach in “Labs Should Heed Lessons from Huge Data Breach.”

Jim Giszczak, JD

“When a lab’s vendor has some type of breach, the lab entity that provided the compromised information could have some liability related to the breach,” explained Jim Giszczak, JD (above), McDonald Hopkins, in an interview with The Dark Report over a similar data breach in 2019. “That’s why every lab should be proactive and do a review to understand each vendor’s policies, procedures, training, and response in the event of a breach. Because your lab needs to know how a vendor will respond to a data security incident, and importantly, how quickly it will respond, it’s critical for lab officials to review the contracts they have with vendors that acquire, or have access to, PHI.” (Photo copyright: McDonald Hopkins.)

Not a Scam

“Unfortunately, it’s not a scam,” stated David Barletta, President and CEO of PRL, in an interview with local Syracuse news WSYR. “This really did happen in April—there was a ransomware attack on our system. We brought in forensic accountants and forensic information teams to come and look at what happened.”

PRL sent out more than 940,000 letters to potential victims of the cyberattack in August, noting that some patients may receive more than one letter.

The complete list of “healthcare entities on whose behalf Practice Resources LLC is providing notice of data incident,” according to PRL, includes:

Although their investigation did not uncover any evidence that personal data was misused, PRL has arranged credit monitoring services free of charge for one year from the date of enrollment. The company is also offering proactive fraud assistance to help people with any questions or in case they become a victim of fraud.

“There were no patient social security numbers that were taken. No medical record information was taken,” Barletta told WSYR. “We really, just out of an abundance of caution, felt that it was necessary that we provide them with credit monitoring for a year—just in case.”

Hundreds of Thousands of Patients Affected by Breach

When PRL discovered the data breach, the company took immediate steps to secure its systems and scrutinize the nature and extent of the incident. They then hired a forensic team to investigate what patient data may have been accessed by the hackers, a process that took several months.  

“It does take a long time because each client has hundreds of thousands of patients maybe,” Barletta explained. “We have several large clients that really bore the brunt of this.”

According to Barletta, PRL bills about $450 million annually for its clients, which include some major institutions in Central New York. The New York state Attorney General’s office is investigating the hacking incident and delving into whether PRL’s data security was adequate. 

As a result of the breach, FamilyCare Medical Group, which serves more than 80 physicians and thousands of patients, lost all of its laboratory data, according to the group’s CEO, Mitchell Brodey, MD. They had to close their lab for several months while their computer system was rebuilt. During this time, all their lab work was sent to another laboratory for analysis, MSN reported

The PRL ransomware attack was what is commonly known as a third-party data breach. This type of breach occurs when sensitive data is stolen from a third-party vendor, or when their systems are used to access and steal sensitive information stored on other systems.

In the United States, the Federal Trade Commission (FTC) is responsible for enforcing federal privacy and data protection regulations. If a breach affects 500 or more individuals, the company must issue a press release and notify the FTC and all affected consumers within 60 days of the discovery of the breach.

Clinical Labs Should Proactively Review Member Agreements

In 2019, our sister publication The Dark Report covered a major data breach affecting more than 20 million patients. That breach occurred when hackers gained access to the data systems of a third-party bill collector and impacted four of the nation’s largest clinical laboratories:

At that time, The Dark Report asked James Giszczak, JD, Chair of the Litigation Department and Co-Chair of the Data Privacy and Cybersecurity Practice Group at McDonald Hopkins, to provide insight on what steps clinical laboratory leaders should take to avoid and handle data breaches.

“One important lesson from this data breach is how critical it is for clinical labs and pathology groups to be proactive in making sure they review their vendor agreements,” Giszczak stated. “In that review, labs need to know the specific measures each vendor is taking to protect the information the lab is providing to their vendors.”

Giszczak suggested that clinical laboratory leaders make sure they understand each vendor’s policies, procedures, training, and response in the event of a data breach. He reiterated that labs could have some liability related to the breach.

-JP Schlingman

Related Information:

Labs Should Heed Lessons from Huge Data Breach

Hackers May Have Breached Medical Billing Records of Nearly One Million CNY Patients

List of Healthcare Entities on Whose Behalf Practice Resources LLC Is Providing Notice of Data Incident

Practice Resources, LLC Announces Data Breach Impacting the Information of 924,138 Patients

PRL Data Incident Notification

Your Stories: The Letter from Practice Resources, LLC is Legit

Third Party Data Breach: How to Prevent and What to Do

Ransomware Strikes Hospitals, Clinical Laboratories, and Medical Clinics without Warning and Is Now a Major Threat to all Healthcare Organizations

Across the nation, healthcare attorneys and others report that ransomware attacks are happening weekly, and that once providers’ data systems are encrypted, they have few options to regain control of their information systems

Ransomware is now the single biggest threat to your hospital, clinical laboratory, and anatomic pathology group’s ability to operate a viable business. Few practice administrators and managers are fully aware of this threat. And yet, many still have not taken even basic steps to protect their organizations from ransomware attacks.

Encryption attacks that shut down a hospital or lab’s information services come without warning, rendering the provider unable to access electronic healthcare records (EHRs), to schedule appointments, or conduct most other normal business activities.

Further, negotiating with the ransomware attackers to obtain a de-encryption key can take weeks. During that time, the hospital or lab cannot access its essential information systems and that disrupts or even stops patient care.

Think this cannot happen to your hospital or lab? Think again.

Just this spring, Scripps Health of San Diego was hit with a ransomware attack. Key information systems were encrypted, and it did not take patients long to notice that they could not email their physicians, access their medical records, or see their test results.

The ransomware attack became the headline story on the San Diego nightly news. Scripps would only admit that many essential information systems had been encrypted and that the organization was using paper to conduct business.

The ransomware attack on Colonial Pipeline of Houston, which took place one week after the Scripps Health attack, also became global news. Colonial Pipeline supplies gasoline and similar fuels to 14 states—from Georgia in the South to New York and New Jersey in the North. Dark Daily readers living along the Atlantic Coast personally experienced the shortage of gasoline in their communities because of the ransomware attack on Colonial Pipeline.

No Ransom Payment, No De-encryption Key

Ransomware is probably the single biggest threat to every hospital and every clinical lab in this country. But few healthcare organizations are taking the essential steps needed to make their information systems more resistant to an encryption attack. Even fewer hospitals and labs have policies or procedures in place that outline how management should react when an encryption attack is first discovered. Yet these attacks are hitting medical providers every week across the US.

Dark Daily surveyed several major law firms that have sizeable healthcare practices. Each firm stated it is contacted weekly by one or more hospitals, labs, and medical clinics that have had their digital systems encrypted, followed by a demand for ransom. The healthcare providers were told by the hackers that if they did not pay the ransom, they would not receive the de-encryption key required to bring their software, apps, and digital systems back into service.

“This is the biggest story in healthcare, yet it gets little attention,” stated Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication The Dark Report. “The reason why you don’t read more news stories about ransomware attacks on hospitals and labs is simple. If it becomes known that a hospital or a lab paid ransom to obtain the de-encryption key needed to restore access to its information systems, that encourages other hackers to attack the organization as well, since the hackers know the organization will pay the ransom. They figure if the provider paid the ransom once, the same provider will likely pay it again.”

Payment of Ransom Does Not Guarantee Restoration of Critical Systems

As bad as a ransomware attack on a hospital, lab, or a medical clinic can be—it can get worse. “Experts involved in helping hospitals and labs respond to a ransomware attack say there is no guarantee the de-encryption key provided by the hackers after payment of ransom will restore access to the encrypted systems,” Michel noted. “We hear reports of hospitals and labs that spent more on their efforts to bring the encrypted systems back online and functioning than they did on the actual ransom.”

To help laboratory managers, CIOs, IT directors, safety and compliance officers, and anatomic pathology laboratory managers and administrators better understand the legal issues triggered by—and your obligation in response to—a ransomware attack, Dark Daily is conducting “Ransomware Protection and Response for Clinical Labs, Hospitals, and Pathology Groups: Effective Steps for Protecting Your LIS, EHR, and Other IT from an Encryption Attack,” on Thursday, August 19, 2021, from 1-2:30 pm Eastern.

This is a must-attend webinar—not only for you—but for everyone in your hospital, health system, or clinical laboratory who will be working to prevent ransomware attacks, or who is involved in restoring digital services following such an attack.

Two experts who are contacted each week by multiple hospitals, labs, and medical clinics that were attacked, had their digital systems encrypted, and received a ransom demand for hundreds of thousands—even millions—of dollars from hackers, will be sharing their knowledge and experience in the legal implications of—and the recovery from—ransomware attacks.

Emily Johnson and Paul Caron

The panelists (above) are:

Johnson and Caron will cover best practices designed to provide crucial training and decision-making skills for handling a ransomware attack on hospital and health system clinical laboratories and anatomic pathology practices. These best practices include:

  • Legal issues triggered by a ransomware attack: What to do when an incident is a breach and when it is not.
  • Your obligations in response to a ransomware attack: HIPAA privacy and other regulatory rules, contractual arrangements (e.g., reference labs), and crisis communication to patients and other stakeholders.
  • Responding to and negotiating with ransomware perpetrators—including the expected “etiquette” in dealing with cybercriminals—and collaborating with consultants who are experienced in how to deal with ransomware demands.
  • And much more.

The roundtable discussion will help you understand how a security incident can occur with or without a breach of protected health information (PHI). Johnson and Caron also will discuss how knowing what to do in each scenario is essential to reducing collateral damage to both patients and your organization, and how to educate your hospital, lab and the broader medical community to address—both proactively and in response—the surging risk of ransomware attacks.

Act now to guarantee your place at this critical webinar. Click HERE to register, or copy and paste the URL https://info.darkdaily.com/ransomware-protection-response-for-clinical-labs-hospitals-and-pathology-groups into your browser.

And because so many healthcare administrators, physicians, and pathologists are working remotely, Dark Daily has arranged special group rates for hospitals, practices, and physicians that would like their essential leaders to participate in this important webinar and roundtable discussion on protecting against—and recovering from—ransomware attacks.

Inquire at info@darkreport.com or call 512-264-7103.

—Michael McBride

Related Information

Ransomware Protection and Response for Clinical Labs, Hospitals, and Pathology Groups

Scripps CEO Says Cyberattack Was Result of Ransomware

Colonial Pipeline Ransomware Attack

Workplaces Must Screen Employees for COVID-19, Say Authorities in the US and Ontario, and This Trend Could Mean Big Business for Clinical Laboratories

As mandatory screenings for private industry workers increases, some states launch free COVID-19 testing for state employees, while engaging medical laboratories to provide such testing

Amid the SARS-CoV-2 pandemic, welcoming employees back to work is not as simple as opening the company’s doors. Businesses based in some areas of the US and Canada are being required by state and provincial governments to conduct employee COVID-19 screenings. For clinical laboratories, the increase in mandatory screening programs could mean an expanding market for employee testing programs and opportunities for lab outreach programs.

But companies and medical laboratories may also face legal and regulatory risks as workplaces reopen and people return.

For example, how do clinical laboratory managers ensure their labs have the information they need to respond to new rules and regulations, and do employers have recourse should an employee receive a COVID-19 test report with an incorrect result?

Not COVID-19 Screening Can Lead to Fines, Imprisonment

In Ontario, under O. Reg. 364/20: Rules for Areas in Stage 3, an amendment to the Reopening Ontario (A Flexible Response to COVID-19) Act, 2020, S.O. 2020, c. 17, workplaces are required to screen employees and visitors for COVID-19 before they enter office buildings, the Society for Human Resource Management (SHRM) reported.

An Ontario Ministry of Health COVID-19 Screening Tool for Workplaces (Businesses and Organizations) instructs businesses on questions to ask of “workers” and “essential visitors” who are being screened before entering a workplace. They include:

  • Is there existence of “new or worsening symptoms,” such as fever or chills, difficulty breathing, and cough?
  • Has the employee travelled outside Canada in the past 14 days?
  • Has the employee had close contact with other confirmed or “probable” COVID-19 cases?

A “probable” case is “a person with symptoms compatible with COVID-19 AND in whom laboratory diagnosis of COVID-19 is inconclusive,” according to a blog post by Justin P’ng, Employment and Labor Lawyer/Associate at international law firm Fasken in Toronto.

“Employers [in Ontario] must now specifically comply with the requirements of the Screening Tool and to implement such screening at any physical workplaces it operates in the province,” P’ng wrote. “Failure to comply can lead to significant penalties, including potentially fines and imprisonment under the legislation.”

It is possible the new requirements may ease Ontario workers’ minds about heading back to work during the pandemic. A Canadian workforce survey of employers and employees during July 2020 by PricewaterhouseCoopers (PwC) Canada found:

  • Most employers (78%) expect a return to the workplace in 2020.
  • Just one in five employees indicated they want to go back to the workplace full-time.

Michigan Makes Remote Work Mandatory

In the US, state rules enforced by the Michigan Occupational Safety and Health Administration (MIOSHA) require employers—for infection prevention reasons—to establish remote work programs for employees, unless it is not feasible for employees to work away from the workplace.

“The employer shall create a policy prohibiting in-person work for employees to the extent that their work activities can feasibly be completed remotely,” MIOSHA said.

Similar to the Ontario law, Michigan employers are also required to establish COVID-19 screenings. The MIOSHA rules direct employers to “conduct a daily entry self-screening protocol for all employees or contractors entering the workplace, including, at a minimum, a questionnaire covering symptoms and suspected or confirmed exposure to people with possible COVID-19, together with, if possible, a temperature screening.”

Michigan employers not in compliance with the state’s requirements for office work may be fined up to $7,000 per violation, a McDonald Hopkins Insights article noted.

Furthermore, anti-retaliation law in Michigan prohibits employers from terminating or “retaliating against” employees who oppose violation of the law or report COVID-19 “health violations,” the McDonald Hopkins Insights article added.

However, Michigan businesses may have protection under the COVID-19 Response and Reopening Liability Assurance Act. The law states a “person who acts in compliance with all federal, state, and local statutes, rules, regulations, executive orders, and agency orders related to COVID-19 that had not been denied legal effect at the time of the conduct or risk that allegedly caused harm is immune from liability for a COVID-19 claim.”

The law defines a “person” as “an individual, partnership, corporation, association, governmental entity, or other legal entity, including, but not limited to, a school, a college or university, an institution of higher education, and a nonprofit charitable organization. Person includes an employee, agent, or independent contractor of the person, regardless of whether the individual is paid or an unpaid volunteer.”

New York Launches Free RT-PCR Tests for Transit Employees

Meanwhile, in New York, free COVID-19 tests are now available on a voluntary basis to 2,000 frontline employees of the Metropolitan Transit Authority, a news release states.

BioReference Laboratories and Quest Diagnostics are performing the RT-PCR testing.

“Quality COVID-19 testing is critical to helping our nation’s frontline workers do their jobs as safely as possible,” Wendi Mader, Executive Director of Employer Population Health at Quest Diagnostics, said in the news release.

New Special Report Available on COVID-19 Employee Testing Programs

As the SARS-CoV-2 pandemic progresses, laws, regulations, and rules pertaining to COVID-19 employee testing and screening will likely continue to develop—and they will vary by area and by test type—making them a challenge to interpret, track, and ensure compliance.

Thus, to help medical laboratory managers and human resources professionals receive the critical, relevant information they need prior to launching COVID-19 testing programs, the Dark Intelligence Group has published a special report, titled, “How to Develop a COVID-19 Employee Testing Program: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues for Clinical Laboratories and Employers.”

Dark Daily Special Report - Covid-19 Employee Testing Program
This exclusive report offers guidance, best practices, and insights necessary to launch and operate high quality, compliant COVID-19 employee testing programs. Clinical laboratories and employers tasked with developing and maintaining coronavirus testing programs will gain critical insights and data from this invaluable special report. (Photo copyright: Dark Intelligence Group.)

Included in the report:

  • Ten regulatory essentials for launching a COVID-19 testing program
  • Test eligibility
  • Order requirements
  • Privacy
  • Contractual and liability issues
  • Infection prevention and OSHA compliance
  • Case studies

This information comes from attorneys at numerous law firms, including:

To access this timely and invaluable special report, click here, or go to: https://www.darkdaily.com/product/how-to-develop-a-covid-19-employee-testing-program-what-clinical-laboratories-need-to-know/ to download.

—Donna Marie Pocius

Related Information:

How to Develop A COVID-19 Employee Testing Program: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues for Clinical Laboratories and Employers

COVID-19 Screening is Mandatory in Ontario Workplaces

Ontario Workplaces Now Required to Screen for COVID-19

New Michigan COVID-19 Legislation

COVID-19 Response and Reopening Liability Assurance Act

Gov Cuomo Announces MTA to Launch Voluntary COVID-19 Screening Program for Frontline Employees

Two Healthcare Attorneys Discuss Remedies for Medical Laboratories Facing Financial Distress Due to COVID-19

Though lenders and landlords may be willing to renegotiate terms, communication is key, the lawyers suggest

COVID-19 has vastly increased demand for clinical laboratory testing. But at many labs, the pandemic has caused much damage to the bottom line. Due to numerous factors—including reductions in elective procedures and increased operating costs—many independent lab companies have seen a 30% to 60% cut in revenue, says attorney Richard S. Cooper, JD, of McDonald Hopkins, a law firm that represents more than 350 medical laboratories across the US.

“Some of that was offset where clinical laboratory companies took on COVID testing. But in our experience, it was a partial offset at best,” he said in an exclusive interview with Dark Daily. Cooper is co-chair of the firm’s National Healthcare Practice Group.

To address these challenges, the firm has advised lab companies to take a hard look at their:

  • operations,
  • market conditions,
  • supplier relationships,
  • lender agreements, and
  • other elements of their businesses.

Lab executives, he says, should consider steps to reduce expenses or increase revenues, such as increasing prices if conditions permit. In extreme cases, medical laboratories may have to consider:

  • Chapter 11 bankruptcy,
  • Consensual out-of-court restructuring, or
  • Buyouts.
Richard S. Cooper, JD, co-chair of the National Healthcare Practice Group at McDonald Hopkins
“I think lenders have been willing to work with borrowers, but I don’t think this has been a ‘get out of jail free’ card,” Richard S. Cooper, JD (above), co-chair of the National Healthcare Practice Group at McDonald Hopkins, told Dark Daily. “Lenders are going to look at borrowers that were struggling before the whole COVID-19 situation with a more critical eye. Lenders seem to be more willing to work with borrowers that were doing well, but then were hit with a temporary hiccup.” (Photo copyright: McDonald Hopkins.)

Cooper, and colleague Jason M. Smith, JD, elaborated on these points during the interview. Smith is chair of the Commercial Finance Group. “The vast majority of my work is representing either lenders or borrowers in credit relationships,” Smith explained.

Dealing with Lenders

For many lab companies facing financial distress, the most important action, the lawyers suggest, may be to review loan or credit agreements and get a better understanding of the lab’s obligations. Then, the lab can approach lenders for potential relief, such as deferred payments or temporary adjustments to reporting requirements.

Either way, “communication is key,” Smith said, adding that labs should first “come up with projections and cashflow analyses and figure out which of those requirements they are not going to be able to meet.”

Then, Smith added, labs should reach out proactively. “Lenders generally don’t like surprises,” he said. “They’re going to be a lot more willing to work with you when they find out about any issues directly from you, as opposed to after receiving financial statements and discovering the issues for themselves.”

Ultimately, clinical lab companies may be able to negotiate better terms, not only with financial institutions, but also with landlords, Cooper said. For example, labs may ask for rent abatement or payment deferrals. These steps “may reduce or eliminate the need to cut back on staff,” Cooper said, “which may be less disruptive of operations.”

When dealing with lenders, Cooper advises against a “Let’s throw everything at the wall and see what sticks” approach. Instead, labs should try “concrete, smaller lists of things that are really important. That’s the best way to come up with a reasonable ask for your lenders and have them take you seriously.”

When to Call Your Lawyer

Cooper says lawyers can play two different roles in these negotiations. “It’s important that lab executives discuss with their lawyers any potential violations of lease and lending documents, what the obligations are, and what the potential legal impact may be.” He added, “Labs should engage and discuss with a lawyer who’s experienced in those areas to understand how lenders and financial institutions might be willing to accommodate the lab’s financial situation by suspending or temporarily modifying the terms of those documents.”

Jason M. Smith, JD of McDonald Hopkins
Jason M. Smith, JD (above), chair of the Commercial Finance Group at McDonald Hopkins, told Dark Daily, “Clinical laboratory companies could approach their lender and/or landlord directly. You don’t necessarily need a lawyer to do that. On the other hand, a lot of clients prefer that their lawyer at least participate in any dialogue with the landlord and lender. But it’s not absolutely necessary. So, the lawyer can be an information resource or an active participant in negotiating.” (Photo copyright: McDonald Hopkins.)

The Bankruptcy Option

Clinical laboratory companies that are in serious financial trouble may have to consider drastic measures, such as bankruptcy. In a Chapter 11 bankruptcy, Cooper explains, you can continue to operate under supervision of the court while restructuring the business and renegotiating terms with lenders. But “there’s always a stigma attached to any kind of restructuring filing,” he said. “It’s public and it can raise questions among your suppliers and customers as to whether you’re sustainable. So, it would be more of a last measure.”

A more preferable course, he says, may be to negotiate a consensual out-of-court workout in which creditors agree to extend repayment terms or reduce debt.

A Good Time for Buyouts?

Another option for distressed lab companies may be buyouts. “We are starting to see a pickup in [merger and acquisition] activity,” Cooper says. “Some of it is normal activity not necessarily driven by financial distress. There’s a company that’s attractive in the marketplace and buyers are interested in that laboratory.”

In other situations, he noted, clinical laboratories might not feel compelled to sell, but “they want to become part of a larger platform with better capital resources to help them withstand the COVID-19 scenario and future market-altering events.”

Cooper continued, “there are other labs that basically say, ‘We’re not going to make it on our own. We need to find a buyer. We need to find capital.’ And then, of course, there are buyers that see market opportunities in labs which are available for acquisition that otherwise might not have been, and perhaps on more favorable terms.”

Some labs, he says, may wait for their revenues to recover, so they can “go to market in a stronger position.” But, “there clearly will be some labs out there that will be available, and available at a lower price than they would have been pre-COVID.”

Regardless of which path a financially-distressed clinical lab company chooses to take as a way to resolve the situation, it is best to take the initiative to consult with experienced attorneys, CPAs, and other advisors while there is still time to negotiate different solutions with lenders, landlords, mortgage companies, and others.

—Stephen Beale

Related Information:

Streaming Webinar | How to Maximize your Laboratory’s Valuation When Preparing for a Sale: Key Steps from a Business and Legal Perspective

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