News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Military’s Fifth Health System Market Cuts Costs by Keeping Pathology Services ‘On-base’

Even US military clinical laboratories strive to cut costs, protect quality, and improve outcomes

Defense Health Agency (DHA), a part of the federal Department of Defense (DOD), recently launched a plan to consolidate healthcare facilities within certain geographical regions and to unify and integrate the military’s clinical laboratory operations in those areas. The goal is to streamline efficiencies and lower costs while maintaining quality lab testing services. 

The DOD operates a nationwide network of medical treatment facilities (MTFs) that include state-of-the-art clinical and anatomic pathology laboratories serving military personnel and their families. These military labs face the same issues of cost, efficiency, and outcomes as do civilian clinical laboratories throughout the United States.

To address those challenges and bring together clinical laboratory services in specific regions, the DHA established the Tidewater Market in April of 2021 to serve select US Air Force, Army, and Navy MTFs in the Washington DC metro area, central North Carolina, Jacksonville, and coastal Mississippi.

Tidewater is the fifth Military Health System (MHS) market created to manage MTFs as they transition into the DHA.

Health.mil—a website maintained by the MHS as an informational resource for those it serves—describes the MHS as “one of America’s largest and most complex healthcare institutions, and the world’s preeminent military healthcare delivery operation.

“Our MHS saves lives on the battlefield, combats infectious disease around the world, and is responsible for providing health services through both direct care [at military hospitals and clinics known as ‘military treatment facilities’] and private sector care to approximately 9.6 million beneficiaries, composed of uniformed service members, military retirees, and family members,” Health.mil notes.

With 9.6 million beneficiaries, MHS is one of the largest healthcare service organizations operating in the United States.

Navy Rear Admiral Darin Via, MD

“The establishment of this market provides a true opportunity to optimize healthcare for our beneficiaries by focusing on outcomes and access across the Tidewater market,” said Navy Rear Admiral Darin Via, MD, Tidewater market manager, in an MHS/DHA news release. “It also allows us to work towards standardization of processes, creating an easier environment for our patients to navigate within.” (Photo copyright: US Navy.)

Finding Efficiencies, Optimizing Clinical Laboratory Processes and Services

In an article outlining the Tidewater Market clinical laboratory initiative, Health.mil noted that “A market is a group of MTFs in one geographic area working together with its TRICARE partners, Veterans Affairs hospitals, other federal healthcare organizations, private sector teaching hospitals and medical universities, as well as other healthcare partners. Markets operate as a system to support the sharing of patients, staff, budget, and other functions across facilities to improve readiness and the delivery and coordination of health services.”

The Tidewater Market provides integrated, affordable, high-quality healthcare services to active-duty service members, military retirees, reservists and national guardsmen, and their families. The market currently serves more than 390,000 beneficiaries.

In 2022, the Tidewater Market Laboratory/Pathology Integration Working Group was created to optimize services while reducing costs within the market. The group was created by US Navy Captain Stacie Milavec, who has more than 23 years of experience in military medicine.

Milavec is a clinical laboratory scientist certified through the American Society for Clinical Pathology (ASCP) and American Medical Technologists (AMT). She served on the board of directors for the Society of American Federal Medical Laboratory Scientists (SAFMLS) and is a member of the American College of Healthcare Executives (ACHE) and American Society for Clinical Laboratory Science (ASCLS).

“One of DHA’s goals with setting up a market structure is to find efficiencies and optimize and standardize processes and services wherever possible,” Milavec said in an MHS/DHA news release. “We’ve been able to do exactly that by collaborating within our working group.”

Resource Sharing between Military Clinical Laboratories

The MTFs that are geographically close to each other helped expedite turnaround times for testing results. By working together, they saved the Tidewater Market an estimated $80,000 during fiscal year 2022.

One of the methods they used to streamline testing and lower costs was to allow resource sharing between facilities within the market. For example, the full-service clinical laboratory located at the Naval Medical Center Portsmouth (NMCP) began performing head and neck pathology cases, breast biopsies, and PAP testing for some of the other facilities within the Tidewater Market. These services were previously performed by other means and in some cases were sent to commercially-contracted clinical laboratories for analysis at a high cost.

The NMCP also took on Human Papilloma Virus (HPV) testing for all MTFs within the market. 

In February of 2023, NMCP began taking on additional clinical chemistry tests from the 633rd Medical Group at Joint Base Langley-Eustis located in Hampton, Virginia. Prior to that collaboration, those tests were sent out to contracted labs off-base for analysis. 

“[Through collaboration between the MTFs] we’ve been able to successfully transition civilian marketplace send-out testing back into the military market by utilizing market resources,” said pathologist US Air Force Captain Dianna Chormanski, MD, Laboratory Medical Director with the 633rd Medical Group at Joint Base Langley-Eustis, in the press release. “I’m a big fan of cooperation and working together, and that’s what a market should be.”

The DHA established the market-based structure as part of the National Defense Authorization Act for Fiscal Year 2017. It’s an example of regional laboratory consolidation within one region of the US where a common effort brought together clinical laboratories operating on military bases of different services. The military’s goal was a unified, integrated medical laboratory operation that could deliver targeted cost savings while maintaining quality lab testing services. It appears to be successful.   

—JP Schlingman

Related Information:

Tidewater Market Saves by Integrating and Optimizing Pathology Services

Tidewater Set to Become Fifth Military Health System Market

New Tidewater Market Strengthens DOD’s Medical Readiness, Promises Better Patient Experience

Pandemic Spotlights the Vital Role of Military Lab Workers

Teladoc Reports $13.7B Loss for 2022, Just Two Years after Livongo Acquisition

Loss could indicate an industrywide slowdown in digital health adoption and suggests medical laboratories will want to continue developing a virtual care strategy

Only two years after Teladoc Health (NYSE:TDOC) completed acquisition of Livongo, a data-based health coaching company, the virtual healthcare provider reported a 2022 net loss of $13.7 billion, a company press release announced.

The loss, which has been described as “historic,” is “mostly from a write-off related to the plummeting value of its Livongo acquisition. … By comparison, in 2021 [just a year earlier], Teladoc posted a net loss of $429 million,” Fierce Healthcare reported.

However, during Teladoc’s fourth quarter earnings call, CEO Jason Gorevic said, “We are pleased with the strong fourth quarter and full-year operating results. Despite a challenging macro environment, we were able to expand our product offerings and enhance the level of care delivered across our integrated whole-person platform.” Teladoc Health’s 2022 revenue was $2,406,840 compared to $2,032,707 in 2021. That’s an 18% increase over last year’s revenue, according to the earnings report. Nevertheless, a month before the earnings call Teladoc laid off 300 non-clinician employees, Fierce Healthcare noted.

Jason Gorevic

“Teladoc Health has been at the forefront of the adoption curve, and we believe that our scale, breadth of product offering, and proven outcomes will enable us to maintain and expand our position in the market,” said Teladoc Health CEO Jason Gorevic during February’s earnings call. Clinical laboratory leaders may view the company’s $13B loss as indication that adoption in telehealth by physicians, healthcare providers, and patients of digital-based health services is not happening as swiftly has been predicted. (Photo copyright: The Business Journals.) 

Predictions in Telehealth Adoption Fall Short

Teladoc Health, based in Purchase, New York, acquired Livongo of Mountain View, California, in October 2020 for $18.5 billion. 

A news release at that time declared that the merger was “a transformational opportunity to improve the delivery, access, and experience of healthcare for consumers around the world.

“The highly complementary organizations,” the release stated, “will combine to create substantial value across the healthcare ecosystem, enabling clients everywhere to offer high quality, personalized, technology-enabled longitudinal care that improves outcomes and lowers costs across the full spectrum of health.”

The deal was hailed as advancing telemedicine and digital health services. As it turned out, though, the demand for those types of services fell far short of the Teladoc’s expectations. One way to interpret the cause of the multi-billion dollar write-down is that adoption of digital health services by physicians, healthcare providers, and consumers is not happening as fast as Teladoc projected.

It may also be that companies allocated too much money to deals during the COVID-19 pandemic, an unstable period of time for making major business decisions.

In fact, worldwide digital health funding fell 57% in 2022 after a high in 2021, according to a CB Insights State of Digital Health 2022 Report.

Teladoc to Reduce Costs while Pursuing Increased Adoption of Virtual Care

Gorevic told analysts during the earnings call that the company needs to reduce costs and reach a market that is “in the early innings.” Year-over-year growth of 6% to 11% is expected in 2023, he said.

“You should expect us to balance growth and margin with an increased focus on efficiency going forward. Part of that approach is rightsizing the cost structure to reflect the current growth rates of the business,” Gorevic said. “The more balanced approach does not mean that we will stop relentlessly pursing growth and increased adoption of virtual care across the industry. Virtual care’s role within the healthcare industry remains underpenetrated, and we will continue to invest to expand our leadership position,” he added.

Digital Health Investing Falls Off

However, citing digital health market data in the new CB Insights report, Becker’s Hospital Review(Becker’s) suggested the digital health bubble may have “popped,” and that funding by investors is falling fast from the “Golden Age” of 2021.  

The digital health category grew by 79% in 2021 to $57.2 billion, a record high, according to data cited by Becker’s. In the fourth quarter of 2021, there were 13 new digital health companies with valuations of at least $1 billion each. But by the end of 2022, digital health funding dropped to $3.4 billion. That’s “a five-year low,” Becker’s reported.

“The drop in funding in digital health companies I feel is a response to the volatility in healthcare where over 50% of hospitals and healthcare providers have posted losses for 2022 and a bleak outlook for 2023,” Darrell Bodnar, Chief Information Officer at North Country Healthcare in Lancaster, New Hampshire, told Becker’s.

And, in a statement about hospitals’ financial health, Fitch Ratings said providers in 2022 reported “weaker profitability and liquidity” as compared to 2021. For most providers, a “rapid financial recovery” is not expected, Fitch noted.

Labs Need Telehealth Strategies

All of this uncertainty in the telehealth/virtual care markets may ultimately benefit clinical laboratories and lab investors who delayed investing in technology that enables supporting physicians and patients using telemedicine visits. Still, it would be smart for medical laboratory leaders to develop a digital health strategy to meet consumer demand for lab testing services in tandem with virtual care visits with healthcare providers. 

—Donna Marie Pocius

Related Information:

Teladoc Health Reports Fourth Quarter and Full Year 2022 Results

Teladoc Sinks $13.7B Loss in 2022 Tied to Plummeting Value of Livongo Acquisition

Teladoc Health and Livongo Merge to Create New Standard in Global Healthcare Delivery, Access, and Experience

State of Digital Health 2022 Report

What is Digital Health?

Teladoc Health Reports $13B Loss in 2022

Early Not-for-Profit Hospital Medians Show Expected Deterioration, Will Worsen

Did the Digital Health Bubble Pop? CIOs Weight In

US News and World Report Ranks Clinical Laboratory Technician 17th Best Healthcare Support Job

High demand for medical laboratory technicians that exists throughout the country motivates some colleges to create training programs to meet this need

Clinical laboratory technicians will be interested to learn that US News and World Report (USNWR) recently ranked their work the 17th Best Healthcare Support Job and 86th of 100 in the magazine’s list of Best Jobs in 2023. The position also ranked “average” in upward mobility and flexibility, but “above average” in stress level. This squares with Dark Daily’s previous reporting on high levels of stress clinical laboratories are still experiencing following the SARS-CoV-2 pandemic.

The median pay, according to USNWR, is $57,800/year and can be as high as $74,530/year. The best paying cities for clinical laboratory technicians are all in California: Redding, Napa, Merced, San Jose, and San Francisco. And the best paying states are New York ($72,500), Rhode Island ($70,580), Connecticut ($70,220), Oregon ($69,330), and California ($68,450).

In comparison to similar jobs in healthcare, clinical laboratory technician earnings exceed Medical Records Technicians, but come in lower than MRI Technologists, Radiologic Technologists, and Cardiovascular Technologists, USNWR noted.

The US Bureau of Labor Statistics, a division of the US Department of Labor, projects the clinical laboratory technician position will grow by 7% between 2021-2031.

Salary graphic

The graphic above, taken from the US News and World Report’s list of “Best Healthcare Support Jobs in 2023,” illustrates how the base salary for clinical laboratory technicians has risen over the past 10 years. Projections are positive for earnings and availability of clinical laboratory positions continuing to grow around the nation. (Graphic copyright: US News and World Report.)

Clinical Laboratory Technician a Growing Profession

The US News and World Report’s definition of this job drew heavily on the US Bureau of Labor Statistics’ Occupational Outlook Handbook for its description of the position “Clinical Laboratory Technician.” The Labor Department clearly defines the difference between a clinical laboratory “technician” and “technologist” and USNWR carried that over into its analysis.

Accordingly, USNWR described this job category by stating “Clinical laboratory technicians are responsible for a number of tasks, including examining body fluids and cells and matching blood for transfusions. The job requires the use of sophisticated laboratory equipment, such as microscopes and cell counters. With continued advancements in technology, lab work has become more analytical, so laboratory personnel should have excellent judgment skills. More complex procedures are reserved for clinical laboratory technologists, who must possess a bachelor’s degree. Technicians, who must hold at least an associate degree, often work under the supervision of technologists.”

Demand for clinical laboratory technicians spans the country and appears to be increasing.

In “Filling Another Labor Gap; Medical Labs,” the Quad-City Times reports that the Trinity College of Nursing and Health Sciences in Rock Island, Illinois, has unveiled a new program to meet that need: the Medical Laboratory Science Program.

The program is the result of a local hospital querying Trinity College about implementing just a program.

“It’s been about a year and a half now, getting it up and rolling,” Stephanie Tieso, MS, MLS(ASCP)CM, Program Director Med Lab Sciences, Trinity College, told Quad-City Times. “I know both big hospital systems in the area are very excited about this coming on, and there’s definitely chatter in the lab community about this new program opening.”

Trinity’s program will be the only one of its kind within a 90-mile radius. The initial cohort will consist of 10 students. The Quad-City Times reports “Program majors will earn a Bachelor of Health Sciences degree and qualify to take the MLS certification exam upon program completion and graduation.”

The creation of this program at Trinity College of Nursing and Health Sciences is just one example of programs that could be needed all over the US in the coming years as demand for clinical laboratory workers grows.

Job Outlook Good but Burnout a Possibility

The US Bureau of Labor Statistics’ Occupational Outlook Handbook states, “About 25,600 openings for clinical laboratory technologists and technicians are projected each year, on average, over the decade. Many of those openings are expected to result from the need to replace workers who transfer to different occupations or exit the labor force, such as to retire.” However, the shortage may also be due to the well-reported worker burnout being experienced across the entire healthcare industry which was exacerbated by the SARS-CoV-2 pandemic.

As Dark Daily reported in “Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic,” burnout in healthcare is a constant problem, especially in overstressed clinical laboratories and anatomic pathology groups.

This ebrief follows the story of Susanna Bator, a former clinical laboratory technician with the Cleveland Clinic and with MetroHealth System in Cleveland, Ohio. Bator shared her story of working in various laboratories during the coronavirus pandemic in an essay she wrote for Daily Nurse titled, “The Hidden Healthcare Heroes: A Lab Tech’s Journey Through the Pandemic.” Bator’s essay is a personalized, human look at the strain clinical laboratory technicians were put under during the pandemic. Her story presents the quandary of how to keep these critical frontline healthcare workers from experiencing burnout and leaving the field.

“We techs were left unsupported and unmentored throughout the pandemic. No one cared if we were learning or growing in our job, and there was little encouragement for us to enter training or residency programs. We were just expendable foot soldiers: this is not a policy that leads to long-term job retention,” she wrote.

This validates US News and World Report’s statistic that the work of clinical laboratory technicians comes with an “above average” level of stress. For those who can handle it, however, the job has many benefits and provides multiple opportunities for growth.

But the burnout Bator and other techs encountered is very real. Hopefully more training programs like the one at Trinity College will become available to provide the learning and support lab techs need as we move into post-pandemic healthcare. As the US News and World Report article shows, clinical laboratory technicians are filling a critical need in the laboratory industry and new training programs will be instrumental to their success.

Ashley Croce

Related Information:

Best Health Care Support Jobs

What is a Clinical Laboratory Technician?

The Mental Health of Healthcare Workers in COVID-19

Clinical Laboratory Technologists and Technicians

Filling Another Labor Gap; Medical Labs

Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic

The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic

Cedars-Sinai Researchers Determine Smartphone App Can Assess Stool Form as Well as Gastroenterologists and Better than IBS Patients

Artificial intelligence performs BSS assessments with higher sensitivity and specificity than human diagnosticians

In a recent study conducted by scientists at Cedars-Sinai Medical Center in Los Angeles, researchers evaluated a smartphone application (app) that uses artificial intelligence (AI) to assess and characterize digital images of stool samples. The app, it turns out, matched the accuracy of participating gastroenterologists and exceeded the accuracy of study patients’ self-reports of stool specimens, according to a news release.

Though smartphone apps are technically not clinical laboratory tools, anatomic pathologists and medical laboratory scientists (MLSs) may be interested to learn how health information technology (HIT), machine learning, and smartphone apps are being used to assess different aspects of individuals’ health, independent of trained healthcare professionals.

The issue that the Cedars Sinai researchers were investigating is the accuracy of patient self-reporting. Because poop can be more complicated than meets the eye, when asked to describe their bowel movements patients often find it difficult to be specific. Thus, use of a smartphone app that enables patients to accurately assess their stools in cases where watching the function of their digestive tract is relevant to their diagnoses and treatment would be a boon to precision medicine treatments of gastroenterology diseases.

The scientists published their findings in the American Journal of Gastroenterology, titled, “A Smartphone Application Using Artificial Intelligence Is Superior to Subject Self-Reporting when Assessing Stool Form.”

Mark Pimentel, MD

“This app takes out the guesswork by using AI—not patient input—to process the images (of bowel movements) taken by the smartphone,” said gastroenterologist Mark Pimentel, MD (above), Executive Director of Cedars-Sinai’s Medically Associated Science and Technology (MAST) program and principal investigator of the study, in a news release. “The mobile app produced more accurate and complete descriptions of constipation, diarrhea, and normal stools than a patient could, and was comparable to specimen evaluations by well-trained gastroenterologists in the study.” (Photo copyright: Cedars-Sinai.)

Pros and Cons of Bristol Stool Scale

In their paper, the scientists discussed the Bristol Stool Scale (BSS), a traditional diagnostic tool for identifying stool forms into seven categories. The seven types of stool are:

  • Type 1: Separate hard lumps, like nuts (difficult to pass).
  • Type 2: Sausage-shaped, but lumpy.
  • Type 3: Like a sausage, but with cracks on its surface.
  • Type 4: Like a sausage or snake, smooth and soft (average stool).
  • Type 5: Soft blobs with clear cut edges.
  • Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea).
  • Type 7: Watery, no solid pieces, entirely liquid (diarrhea). 

In an industry guidance report on irritable bowel syndrome (IBS)and associated drugs for treatment, the US Food and Drug Administration (FDA) said the BSS is “an appropriate instrument for capturing stool consistency in IBS.”

But even with the BSS, things can get murky for patients. Inaccurate self-reporting of stool forms by people with IBS and diarrhea can make proper diagnoses difficult.

“The problem is that whenever you have a patient reporting an outcome measure, it becomes subjective rather than objective. This can impact the placebo effect,” gastroenterologist Mark Pimentel, MD, Executive Director of Cedars-Sinai’s Medically Associated Science and Technology (MAST) program and principal investigator of the study, told Healio.

Thus, according to the researchers, AI algorithms can help with diagnosis by systematically doing the assessments for the patients, News Medical reported.

30,000 Stool Images Train New App

To conduct their study, the Cedars-Sinai researchers tested an AI smartphone app developed by Dieta Health. According to Health IT Analytics, employing AI trained on 30,000 annotated stool images, the app characterizes digital images of bowel movements using five parameters:

  • BSS,
  • Consistency,
  • Edge fuzziness,
  • Fragmentation, and
  • Volume.

“The app used AI to train the software to detect the consistency of the stool in the toilet based on the five parameters of stool form, We then compared that with doctors who know what they are looking at,” Pimentel told Healio.

AI Assessments Comparable to Doctors, Better than Patients

According to Health IT Analytics, the researchers found that:

  • AI assessed the stool comparable to gastroenterologists’ assessments on BSS, consistency, fragmentation, and edge fuzziness scores.
  • AI and gastroenterologists had moderate-to-good agreement on volume.
  • AI outperformed study participant self-reports based on the BSS with 95% accuracy, compared to patients’ 89% accuracy.

Additionally, the AI outperformed humans in specificity and sensitivity as well:

  • Specificity (ability to correctly report a negative result) was 27% higher.
  • Sensitivity (ability to correctly report a positive result) was 23% higher.

“A novel smartphone application can determine BSS and other visual stool characteristics with high accuracy compared with the two expert gastroenterologists. Moreover, trained AI was superior to subject self-reporting of BSS. AI assessments could provide more objective outcome measures for stool characterization in gastroenterology,” the Cedars-Sinai researchers wrote in their paper.

“In addition to improving a physician’s ability to assess their patients’ digestive health, this app could be advantageous for clinical trials by reducing the variability of stool outcome measures,” said gastroenterologist Ali Rezaie, MD, study co-author and Medical Director of Cedars-Sinai’s GI Motility Program in the news release.

The researchers plan to seek FDA review of the mobile app.

Opportunity for Clinical Laboratories

Anatomic pathologists and clinical laboratory leaders may want to reach out to referring gastroenterologists to find out how they can help to better serve gastro patients. As the Cedars-Sinai study suggests, AI smartphone apps can perform BSS assessments as good as or better than humans and may be useful tools in the pursuit of precision medicine treatments for patient suffering from painful gastrointestinal disorders.

—Donna Marie Pocius

Related Information:

Smartphone Application Using Artificial Intelligence is Superior to Subject Self-Reporting When Assessing Stool Form

Study: App More Accurate than Patient Evaluation of Stool Samples

Industry Guidance Report: Irritable Bowel Syndrome—Clinical Evaluation of Drugs

Artificial Intelligence-based Smartphone App for Characterizing Stool Form

AI Mobile App Improves on “Subjective” Patient-Reported Stool Assessment in IBS

Artificial Intelligence App Outperforms Patient-Reported Stool Assessments

Does Giving a Patient a $75 Gift Card to Send in a Clinical Laboratory Test Specimen Violate Federal Fraud Laws? A Whistleblower Lawsuit Argues ‘Yes!’

Novel scheme by medical laboratory company to induce patients to collect and return their own specimen for testing is central to a federal whistleblower case alleging violations of the Anti-Kickback Statute

Handing out gift cards only to patients who return a specimen to a clinical laboratory company for colorectal cancer screening is a unique approach that is now at the center of a federal qui tamcase filed by a retired Indiana pathologist.

The defendant in this whistleblower lawsuit is Exact Sciences Laboratories and its parent company Exact Sciences Corporation (NASDAQ:EXAS). Last month, a federal judge ruled the court case will proceed following attempts by the defendant’s attorneys to have the case dismissed.

The plaintiffs (United States of America ex rel. Niles Rosen, MD) allege Exact Sciences Laboratories violated the Federal Anti-Kickback Statute (AKS) and False Claims Act by offering $75 gift cards to induce patients to return self-collected fecal samples for the lab’s Cologuard at-home colon cancer screening kit through its Patient Compliance Program. 

Exact Sciences refuted the allegations and moved to have the case dismissed claiming it “had a good faith belief that its [Patient Compliance Program] complied with the law and thus lacked the requisite intent for a violation of the AKS,” according to court documents. The court denied Exact Sciences’ motion to dismiss.

Brian Boynton, JD

“We are grateful for the hard work and courage of those private citizens who bring evidence of fraud to the Department’s attention, often putting at risk their careers and reputations,” said Brian Boynton, JD (above), Principal Deputy Assistant Attorney General and head of the federal Department of Justice (DOJ) Civil Division in a February 7, 2023, DOJ statement. “Our ability to protect citizens and taxpayer funds continues to benefit greatly from their actions.” Clinical laboratory managers will want to follow this and other qui tam cases claiming violation of anti-kickback laws. (Photo copyright: Department of Justice.)

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Was Exact Sciences’ Patient Compliance Program a Kickback?

Cologuard is a non-invasive testing kit utilized by people to screen for colorectal cancer in the privacy of their own homes. It is intended for those over the age of 45 who are at low or average risk for the disease. Exact Sciences regularly runs television advertisements urging individuals to be screened for colorectal cancer using the Cologuard test.

Following a physician’s order, and after receiving the testing kit in the mail, individuals collect a stool sample using the specimen container in the kit and return the sample to Exact Sciences Laboratories (ESL) for analysis. The test works by looking for certain DNA markers and blood in the stool sample. 

According to Report on Medicare Compliance from the Health Care Compliance Association (HCCA), in 2017, a gastroenterologist ordered the Cologuard kit for Rosen, the whistleblower, but Rosen chose not to return a stool sample to ESL. A few months later, ESL sent Rosen a letter offering him a $75 Visa gift card if he performed the at-home specimen collection and then returned it to ESL by March 22, 2018. Persuaded by the offer, Rosen collected a sample, returned it to ESL, and received the gift card. 

As part of its Patient Compliance Program, ESL analyzed Rosen’s sample and received $499 from Medicare for performing the test. The complaint filed against Exact Sciences states Medicare paid Exact Sciences more than $160 million for a total of 334,424 Cologuard tests in 2018 while the company offered “unlawful cash equivalent inducements directly to Medicare beneficiaries,” COSMOS reported.

“It was a straight-up kickback,” Rosen’s attorney Marlan Wilbanks, JD, Senior Partner at Atlanta law firm Wilbanks and Gouinlock, told COSMOS. “You can’t offer cash or cash equivalents to anyone to induce them to use a government service.”

DOJ Elects to Not Intervene in Lawsuit

In February 2020, Exact Sciences received a civil investigation demand by the US Department of Justice (DOJ) regarding the gift card incentive. The DOJ later filed a notice that it had elected to decline intervention in the lawsuit. This action did not prevent Rosen from continuing with the lawsuit. Accordingly, in April of 2021, he filed an amended complaint against Exact Sciences alleging violations of the Federal Anti-Kickback Statute and False Claims Act. 

Rosen is seeking a monetary award for himself, and on behalf of the US government, for civil penalties, treble damages, fees, and costs. 

According to Report on Medicare Compliance, Exact Sciences “refuted the allegations and asserted, among other things, that the arrangement qualifies for the preventive care safe harbor to the anti-kickback statute (AKS) and that the complaint fails for many reasons.”

Exact Sciences also noted in its motion to dismiss that “encouraging a patient to have a medical service that was already ordered by a provider isn’t an inducement under the AKS.”  

At this time, the case remains unresolved and continues in federal court.

DOJ Recovers Billions of Taxpayer Dollars from AKS Violations

A qui tam lawsuit or action is a method available for individuals to help the government circumvent fraud and recover money for taxpayers. Types of fraud included in these cases often pertain to Medicare and Medicaid services, defense contractor fraud, and procurement fraud.

According to the DOJ, over $1.9 billion was recovered as a result of qui tam lawsuits pursued by either the government or whistleblowers during fiscal year 2022. The number of these types of lawsuits has increased dramatically over the years with a total of 652 qui tam cases filed in 2022 alone.

Thus, clinical laboratory professionals should be aware that this type of novel scheme to generate more patients could possibly lead to legal issues. Dark Daily would like to credit Laboratory Economics for calling attention to this fascinating case of alleged illegal inducement involving a medical laboratory company. 

—JP Schlingman

Related Information:

Legal Corner: Niles Rosen v Exact Sciences

FCA Lawsuit Over Patient Gift Cards Survives Motion to Dismiss

United States of America ex rel. Niles Rosen, MD, v. Plaintiff, Exact Sciences Corporation and Exact Sciences Laboratories, LLC [motion to dismiss]

United States of America ex rel. Niles Rosen, MD, v. Plaintiff, Exact Sciences Corporation and Exact Sciences Laboratories, LLC [entry of an order staying discovery]

Report on Medicare Compliance

False Claims Act Settlements and Judgments Exceed $2 Billion in Fiscal Year 2022

IRS Expands Preventive Care Benefits Under High Deductible Health Plans

What Is Colorectal Cancer?

HHS: Fraud and Abuse Laws

Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

What It Means to Be a Clinical Laboratory Whistleblower Outlined in Newly Released ‘Tell-All’ Book by Lab Executive Chris Riedel

Biodiagnostic Laboratory Services Leaders Sentenced to Prison in $100-Million Lab Test Kickback Scheme That Also Led to Convictions of 38 Physicians

Healthcare Cyberattacks at Two Hospitals Prompt Tough Decisions as Their Clinical Laboratories Are Forced to Switch to Paper Documentation

Recent intrusions into the hospitals’ IT systems resulted in blocked medical records including medical laboratory data

Healthcare cyberattacks continue to be a threat that bring potentially costly business consequences for clinical laboratories. Just in the past month, two hospital systems had their health information technology (HIT) systems disrupted due to security incidents. In response, the hospitals’ medical laboratories were forced to switch from digital to paper documentation and, in at least one case, the organization reportedly had difficulty accessing electronic laboratory test results.

The incidents took place at 772-bed Tallahassee Memorial HealthCare (TMH) in Florida and 62-bed Atlantic General Hospital (AGH) in Berlin, Maryland.

At Tallahassee Memorial, an “IT security issue” on Feb. 2 resulted in the organization shutting down its IT systems for 13 days, including at its clinical laboratory. The hospital’s computer network went back online on Feb. 15, according to a news release.

At Atlantic General Hospital, according to an AGH news release, IT personnel discovered a ransomware attack on Jan. 29 that affected the hospital’s central computer system. As a result, the walk-in outpatient laboratory was closed until Feb. 14.

These recent cyberattacks underscore the importance for clinical laboratory leaders to have plans and procedures already in place prior to a disruption in access to critical patient data.

Ben Denkers

Healthcare cyberattacks can be a “complete blindside for a lot of organizations that think they have protections in place because they bought a product or they developed a policy,” said Ben Denkers (above), Chief Innovation Officer at CynergisTek, an Austin, Texas-based cybersecurity company, in an exclusive interview with The Dark Report. Since clinical laboratory test results make up about 80% of a patient’s medical records, disruption of a hospital’s IT network can be life threatening. (Photo copyright: The Dark Report.)

Laboratory Staff Unable to View Digital Diagnostic Results at Tallahassee Memorial

Though the exact nature of the incident at Tallahassee Memorial HealthCare has not been divulged, hospital officials did report the incident to law enforcement, which suggests a cyberattack had occurred.

Electronic laboratory test results were among the casualties of the IT difficulties at TMH. “Staff have been unable to access digital patient records and lab results because of the shutdown,” a source told CNN.

Attempts by Dark Daily to reach a medical laboratory manager for comment at TMH were unsuccessful. However, in a news release posted online shortly after the cyberattack, the health system advised staff members on dealing with the IT outages.

“Patients and families may notice the switch to paper documentation during registration, admission, or during their care, as our providers will be using paper forms, prescription pads, handwritten notes, or other similar paper methods where they may usually use an electronic process,” the news release stated. “We apologize for any delays this may create. We practice for situations like this, and we are prepared to provide safe, high-quality care to our patients during computer system downtimes.”

Atlantic General Hospital Reports Ransomware Incident to the FBI

At Atlantic General Hospital, the outpatient walk-in laboratory and outpatient imaging department both temporarily closed because of the ransomware attack.

Staff members throughout the hospital were “forced to manually check patients in and out of appointments and record all other information by hand instead of online,” Ocean City Today reported.

The hospital immediately informed the FBI of the ransomware incident and continues to work with an incident response team to determine whether criminals accessed any sensitive data. It was not clear whether the organization ultimately paid a ransom to unlock its systems.

The hospital’s medical laboratory director did not respond to an email from Dark Daily seeking further comment.

Healthcare Cyberattacks Attempt to Gain Access to Data

As we covered in “Ransomware Strikes Hospitals, Clinical Laboratories, and Medical Clinics without Warning and Is Now a Major Threat to all Healthcare Organizations,” healthcare organizations have increasingly been a target of cybercriminals and hackers who are after valuable patient data. For example, the healthcare and public health sector accounted for 25% of ransomware complaints as of October 2022, according to data from the FBI, as reported by the federal Cybersecurity and Infrastructure Security Agency.

Therefore, it is critical that clinical laboratory and hospital staff work with their IT counterparts to verify that technology and processes are in place to protect access to patient data.

In “Labs Must Audit Their Cybersecurity Measures,” Ben Denkers, who at that time was Chief Innovation Officer at CynergisTek, a cybersecurity firm based in Austin, Texas, told The Dark Report, “Testing, validating, and auditing whether measures are working as designed is a change of mentality for a lot of organizations.” (If you don’t subscribe to The Dark Report, try our free trial.)

An IT network attack is an attempt by a cybercriminal to gain unauthorized access to devices that contain and exchange data within an organization. Although this information may be on individual devices or on servers, network attacks are often only possible after a hacker enters a system through an endpoint, such as an individual’s email inbox.

“It’s important to understand that while the network server itself might have ultimately been the target, that doesn’t necessarily mean that it was compromised first,” Denkers told The Dark Report. “Phishing is a perfect example of a way an attacker could first gain access to a workstation, and then from there move laterally to a server.”

The final cost of a healthcare cyberattack often exceeds the ransom. Media coverage can lead to an organization’s diminished reputation within the community, and if protected health information (PHI) is accessed by the criminals, a hospital or health system may need to pay for identity theft monitoring for affected patients.

There also are regulatory repercussions that can be costly depending on the circumstances surrounding a cyberattack. For example, on Feb. 2, the US Department of Health and Human Services’ Office for Civil Rights announced a settlement with Banner Health Affiliated Covered Entities (Banner Health), a nonprofit health system headquartered in Phoenix, to resolve a data breach resulting from a hacking incident in 2016. That incident disclosed PHI for 2.81 million patients.

As part of the settlement, Banner Health paid a $1.25 million penalty and will carry out a corrective action plan to protect PHI in the future and resolve any alleged HIPAA violations, according to the HHS Office for Civil Rights.

This hefty penalty is a reminder to pathologists and clinical laboratory managers that—when it comes to cyberattacks—the classic adage “an ounce of prevention is worth a pound of cure” is appropriate advice.

—Scott Wallask

Related Information:

FBI Working with TMH to “Assess the Situation;” Computers Still Offline after Cyber Incident

TMH: Progress on IT Security Event Wednesday, Feb. 15, 2023

Tallahassee Memorial Managing IT Security Issue

CISA: Alert (AA22-294A)

Apparent Cyberattack Forces Florida Hospital System to Divert Some Emergency Patients to Other Facilities

Atlantic General Mum on Ransomware Event Details after System Are Restored

Atlantic General Hospital System Still Down Following Ransomware Attack

Atlantic General Hospital Fully Operational Following Cybersecurity Event

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

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