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Clinical Laboratories and Pathology Groups

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Employers Adopt New Alternative to Group Coverage to Cut Health Insurance Costs

ICHRAs allow companies to compensate employees for insurance purchased in individual markets and may help clinical laboratories reduce patient bad debt

Both employees and their employers are frustrated with current options for health coverage. Now, a recent report from the HRA Council suggests that more employers are turning to Health Reimbursement Arrangements (HRA) as an alternative to traditional group insurance coverage to cope with the increasing cost of employee health benefits. This will be of interest to clinical laboratories that must collect copays/deductibles from patients. Health insurance arrangements that make it easier for patients to pay help labs reduce patient bad debt.  

According to its website, HRA Council is “dedicated to improving and expanding health coverage options for millions of workers by giving employers better ways to offer workers health insurance.”

The non-partisan advocacy organization, which consists of insurers, brokers, employers, and other stakeholders, estimates that only 500,000 workers are currently covered by these plans nationwide. That number of workers represents a 29% increase since 2023, with most of the growth coming from large employers.

Under HRA arrangements, employers provide non-taxed financial assistance to workers who then obtain coverage for themselves and/or their families in the insurance marketplace.

One type of plan, known as the Qualified Small Employer HRA (QSEHRA), was established as part of the 21st Century Cures Act, which Congress passed in 2016. QSEHRAs, however, are available only to businesses with 50 or fewer full-time (or equivalent) employees. Most of the recent growth has come from Individual Coverage HRAs (ICHRA), established under regulations issued by the Trump Administration in 2019.

In contrast to QSEHRAs, ICHRA plans are available to companies of any size, HRA Council notes.

“It’s a way to offer coverage to more diverse employee groups than ever before and set a budget that controls costs for the companies,” HRA Council Executive Director Robin Paoli told KFF Health News.

“ICHRAs are bringing a fresh new approach for employers who need a new or different solution to enable providing health benefits to their employees,” said Andrew Reeves (above), senior vice president and general manager, Gravie ICHRA, in the HRA Council report. Gravie is one of the health benefits companies allied with HRA Council. “Through the defined contribution approach that ICHRA brings, employers are now able to set their budget and enable employees to make their own individual decisions on the coverage they need for themselves and their families. ICHRAs are delivering an approach to employee benefits that is both stable yet at the same time flexible for the individual,” he added. These types of alternatives to traditional employer-sponsored health plans may also help clinical laboratories and anatomic pathology groups reduce patient bad debt. (Photo copyright: LinkedIn.)

How ICHRA Plans Work

As explained by HRA Council, “an ICHRA allows the employer to allocate to each employee a specific amount of money to spend on ACA [Affordable Care Act]-compliant individual health insurance plans. Employees then purchase their own plans, and the employer reimburses them up to the allocated amount.”

The rule allows employers to define up to 11 classes of workers and offer different benefit packages to each. These benefits can be based on characteristics such as:

  • geography,
  • whether the worker is employed full-time, part-time, or seasonally,
  • whether the worker is paid a salary or hourly wage, and
  • whether the worker is covered by a collective bargaining agreement.

Employers can choose to offer ICHRAs to some classes and traditional group plans to others. Within each class of employee, employers also can vary compensation based on age—up to a 3-to-1 ratio—since older workers will generally pay higher premiums than younger ones.

For example, the HRA Council explains, “if an employer offers its 26-year-old employee $300 per month, it could only offer the oldest employee up to $900 per month.”

However, some consumer advocates have pointed to potential downsides of these plans, KFF Health News reported.

Raising Concerns

Analysts affiliated with USC-Brookings Schaeffer Initiative for Health Policy raised concerns about ICHRAs in a 2018 Brookings white paper and in a 2019 commentary.

The rule, they concede, provides guardrails to prevent companies from moving only their sicker employees—the ones most costly to cover—to the individual market. For example, employers must offer the HRAs to entire classes of workers, and the rule prevents them from defining classes that contain only a small number of employees.

However, the authors contend that employers can still target HRAs to classes more likely to be sick while offering group coverage to other classes. In general, they argue, employers with sicker workforces will be most attracted to HRAs. As these workers enter individual insurance markets premiums could rise, particularly “in states that today have individual markets with a relatively low-cost mix of enrollees,” the authors wrote.

Although the rule allows companies to vary compensation based on age, older workers will still pay more for insurance unless the contribution covers the entire cost of the premium. This would likely make the HRAs “less attractive to employers by making it harder for employers to avoid leaving some workers worse off,” the authors noted.

The Brookings authors also observed that workers who accept the contributions are ineligible for premium tax credits enabled by the Affordable Care Act.

KFF Health News noted other potential downsides as well. “Plans sold on the individual market often have smaller provider networks and higher deductibles than employer-sponsored coverage. Premiums are often higher than for comparable group coverage.”

In addition, ICHRAs can create administrative headaches that have prompted some employers to return to group plans. “Instead of a company paying one group health plan premium, dozens of individual health insurers may need to be paid,” KFF Health News reported. “And employees who’ve never shopped for a plan before need help figuring out what coverage works for them and signing up.”

One Employer’s Example

KFF Health News highlighted one organization that appears to be happy with its newly adopted ICHRA: Lycoming College in Williamsport, Penn. The school, which provides health benefits for 400 faculty, staff, and family members, saved $1.4 million in healthcare costs in the first year after implementing the plan. “Employees saved an average of $1,200 each in premiums,” KFF noted.

Prior to the transition, one employee with a family of five paid $411 per month for a plan that had a $5,600 annual deductible. Under the ICHRA, he pays $790 per month with no deductible.

“It’s nice to have the choice to balance the high deductible versus the higher premium,” he told KFF Health News. Before, “it was tough to budget for that deductible.”

Which is where the benefit to clinical laboratories comes back in. Making it easier and affordable for patients to pay their co-pays and deductibles also means more patients showing up at labs for doctor ordered tests and blood draws.

—Stephen Beale

Related Information:

Increasingly Popular Benefits Model Trends Among Large and Small Businesses–and Their Employees

Some Employers Test Arrangement to Give Workers Allowance for Coverage

Why Oscar Health Co-Founder Mario Schlosser is bullish on ICHRA

The Shift from Traditional Employer-Sponsored Coverage to ICHRA: The Health Plan Perspective

HealthCare.gov Hopes to Profit from ICHRA Boom

New Report Illustrates How ICHRA Is Reshaping Health Benefits for Employers and Employees Alike

Evaluating the Administration’s Health Reimbursement Arrangement Proposal

The Trump Administration’s Final HRA Rule: Similar to the Proposed but Some Notable Choices

American Society of Radiology Leaders Identify Seven ‘Most Pressing’ Challenges to Radiology Profession

Managers of pathology groups and clinical laboratories can learn from the challenges confronting the radiology profession

Members of the Intersociety Committee of the American Society of Radiology (ACR) recently met in Coronado, Calif., to discuss the “most pressing” challenges to their profession and investigate possible solutions, according to Radiology Business. Many of these challenges mimic similar challenges faced by anatomic pathology professionals.

The radiology leaders identified seven of the “most important challenges facing radiology today.” They include: declining reimbursement, corporatization and consolidation, inadequate labor force, imaging appropriateness, burnout, turf wars with nonphysicians, and workflow efficiency, according to a report on the meeting published in the Journal of the American College of Radiology (JACR).

“Solving these issues will not be easy,” said Bettina Siewert, MD, diagnostic radiologist at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Mass., professor of radiology at Harvard, and lead author of the JACR report, in the JACR. “This is a collection of ‘wicked’ problems defined as having (1) no stoppable rule, (2) no enumerable set of solutions or well-described set of permissible operations, and (3) stakeholders with very different worldviews and frameworks for understanding the problem,” she added.

“The Intersociety Committee is a freestanding committee of the ACR established to promote collegiality and improve communication among national radiology organizations,” JACR noted.

“Taken together, a ‘perfect storm’ of pressures on radiologists and their institutions is brewing,” said Bettina Siewert, MD (above), diagnostic radiologist at Beth Israel Deaconess Medical Center in Boston, Mass., professor of radiology at Harvard, and lead author of the JACR report. Wise pathology and clinical laboratory leaders will see the similarities between their industry’s challenges and those facing radiology. (Photo copyright: Beth Israel Deaconess Medical Center.)

How Radiology Challenges Correlate to Pathology Practices

Here are the seven biggest challenges facing radiology practices today as identified by the Intersociety Committee of the ACR.

Declining Reimbursement: According to the ACR report, radiologists in 2021 performed 13% more relative value units (RVUs) per Medicare beneficiary compared to 2005. However, the inflation-adjusted conversion factor fell by almost 34%––this led to a 25% decline in reimbursements.

This issue has plagued the pathology industry as well. According to an article published in the American Journal of Clinical Pathology (AJCP), prior to adjusting for inflation, the average physician reimbursement increased by 9.7% from 2004 to 2024 for all included anatomic pathology CPT codes. After adjusting for inflation, the average physician reimbursement decreased by 34.2% for included CPT codes. The greatest decrease in reimbursement observed from 2004 to 2024 was for outside slide consultation at 60.5% ($330.12 to $130.49), followed by pathology consultation during surgery at 59.0% ($83.54 to $34.29). The average CAGR was -2.19%,” the authors wrote.

“Our study demonstrates that Medicare physician reimbursement for common anatomic pathology procedures is declining annually at an unsustainable rate,” the AJCP authors added.

The radiologists who identified this trend in their own field suggest that medical societies could lead the push to minimize the reimbursement cuts. Pathologists could also adopt this ‘strength in numbers’ mentality to advocate for one another.

Corporatization Consolidation: The authors of the ACR report identified this issue as limiting job opportunities for radiologists particularly in private practice. Pathology professionals have seen the same trend in their field as well. Increasingly, small pathology groups have been consolidated into larger regional groups. Some of those larger regional pathology groups will then be acquired by public laboratory corporations.

The authors of the ACR report suggest radiologists should be educated on the pros and cons of consolidation. They also suggest pursuing unionization.

Inadequate Labor Force: In both radiology and pathology there is a supply-and-demand issue when it comes to labor. Staffing shortages have been felt across all of healthcare, but particularly among pathology groups and clinical laboratories. Siewert and her co-authors suggest a three-pronged approach to address this issue:

  • Creating residency positions in private practice.
  • Recruiting international medical graduates.
  • Increasing job flexibility.

Pathology professionals could apply these same ideas to help close the gap between the open positions in the field and the number of professionals to fill them.

Imaging Appropriateness: A gap between service capacity and service demand for radiology imaging has created a frustrating mismatch between radiologists and clinicians. Radiology experts point to overutilization of the service causing the supply-and-demand crisis. Comparatively, pathologists see a similar issue in complex cases requiring more pathologist time to come to an appropriate diagnosis and identify a care plan.

“To facilitate this reduction, better data on imaging outcomes for specific clinical questions are urgently needed,” the authors of the ACR report wrote as a possible solution. “Considering the magnitude of the mismatch crisis, radiologists may also need to consider expanding their consultative role to include that of a gatekeeper, as is done in other more resource-controlled countries.”

Burnout: Perhaps one of the most talked about subjects in the medical field has been burnout. The issue has been thrust to the forefront with the COVID-19 pandemic; however, the burnout crisis began before the pandemic. About 78% of radiologists surveyed for this report claimed to be exceeding their personal work capacity.

The authors of the ACR report suggest a structured approach to air grievances without descending into despair. “Using a team approach based on the concept of listen-sort-empower, burnout can be combatted by fostering free discussion between frontline workers and radiologists,” they said. “Facilitators unaffiliated with the radiology department can help to maintain focus on gratitude for positive attributes of the work and the institution as well as to keep the sessions on task and prevent them from devolving into complaint sessions with a subsequent loss of hope.”

A similar approach could be applied to pathology groups and clinical laboratory to combat worker burnout as well.

Turf Wars with Nonphysicians: Over the last five years the number of imaging exams being interpreted by nonphysician providers has increased by 30%, according to the ACR report. The writers emphasized the need for increased understanding and awareness about the importance of physician-led care. They suggest solidarity among hospital medical staff to provide a united front in addressing this issue in hospital bylaws.

In pathology, the counterpart is how large physician groups are bringing anatomic pathology in-house. This has been an ongoing trend for the past 20 years. It means that the pathologist is now an employee of the physician group (or a partner/shareholder in some cases).

Increase Workflow Efficiency: Image interpretation accounts for only 36% of the work radiologists perform, the ACR report noted. This issue has a direct counterpart in pathology where compliance requirements and various tasks take time away from pathologist diagnosis. These issues could be solved by working AI into tasks, delegating non-interpretive tasks to other workers, and improving the design of reading rooms. All of these possible solutions could also be applied to clinical pathologists.

These issues being faced by radiologists compare directly to similar issues in the clinical pathology world. Pathologists and pathology group managers would be wise to learn from the experience of their imaging colleagues and possibly adopt some of the ACR’s suggested solutions.

—Ashley Croce

Related Information:

The 7 Most Pressing Challenges in Radiology Practice: A ‘Perfect Storm’ is Brewing

Seven Challenges in Radiology Practice: From Declining Reimbursement to Inadequate Labor Force: Summary of the 2023 ACR Intersociety Meeting

The Decline of Medicare Reimbursement in Clinical Pathology

In Canada, Shortage of Medical Laboratory Technologists and Radiology Technicians Continues to Delay Care

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

Commonwealth Fund Health Insurance Survey Shows One Out of Four Americans is Underinsured

Study findings highlight financial impact underinsured have on healthcare providers, including clinical laboratories and pathology groups

Commonwealth Fund’s 2024 Biennial Health Survey released in November shows that not only are Americans underinsured, but many are swimming in medical debt. This is not good news for clinical laboratories. Simply put, labs must collect deductibles, copays, and out of pocket amounts from insured patients. If the patient is underinsured, that means the lab probably has to collect more—even 100%—of total charges directly from the patient.

The study conducted between March and June of 2024 collected data from 8,201 respondents ages 18-64, and despite two of every three respondents carrying health insurance through their employers, one of every four is underinsured, according to a Commonwealth Fund news release.

A further 44% of respondents have medical debt, with one of every four calling their out-of-pocket payments “nearly unaffordable,” the news release notes. Additionally, one out of five had a gap in coverage during the year.

“Congress, employers, insurers, and healthcare providers all play a role in lowering costs and making care more affordable, so families can avoid debt and get the care they need to stay healthy,” said Sara R. Collins, PhD, lead study author and Commonwealth Fund Senior Scholar and Vice President for Health Care Coverage and Access and Tracking Health System Performance, in the news release.

Astute laboratory managers will look beyond the study’s face value and consider the profound impact such findings could have on their own labs.

“While having health insurance is always better than not having it, the findings challenge the implicit assumption that health insurance in the United States buys affordable access to care,” the Commonwealth Fund said of its 2023 study. This sentiment rings true in the Funds’ latest findings as well.

“The Affordable Care Act has covered 23 million people and cut the uninsured rate in half. But high costs are a serious problem for many Americans, regardless of the kind of insurance they have,” said Sara R. Collins, PhD (above), lead study author and Commonwealth Fund Senior Scholar and Vice President for Health Care Coverage and Access and Tracking Health System Performance, in a news release. Clinical laboratories and anatomic pathology groups are greatly affected by underinsured patients. (Photo copyright: Commonwealth Fund.)

Labs Often Must Collect Payments Upfront

Many patients are in high deductible health plans and may forgo or delay ordered lab tests. Labs collect patient deductibles, copays, and out-of-pocket expenses directly from patients. However, underinsured patients may be required to pay for 100% of the services they receive, requiring the lab to collect these payments upfront.

Underinsured patients already facing a mountain of debt may struggle to pay for lab services. The debt many owe is substantial. “Nearly half (48%) of all adults with medical debt owe $2,000 or more; one of five (21%) carry a staggering $5,000 or more in debt,” Commonwealth Fund noted in its study.

Thus, collecting money owed is proving to be a problem for healthcare providers. Patient collection rates are plummeting to 48%, with “providers writing off more bad debt from patients with insurance,” TechTarget reported.

“Lower patient collection rates left providers facing bad debt. The analysis showed that 1.54% was the bad debt write-offs as a percentage of total claim charges in 2023. Researchers note that the percentage may be small, but the total cash amount equated to over $17.4 billion last year,” TechTarget added.

Having some rather than no insurance is not the safety net for patients previously thought. When it comes to the insured, their debt “accounts for 53% of the estimated $17.4 billion that hospitals, health systems, and medical practices wrote off as bad debts in 2023,” Business Wire noted, citing data from Kodiak Solutions’ quarterly revenue cycle benchmarking report.

Delaying Critical Lab Tests

The challenges the insured face with debt impacts labs in the long run. A staggering 57% of survey respondents reported passing on needed care because they could not afford it, and of those, 41% said their health concerns worsened when they denied themselves that care, Commonwealth Fund noted.

Increasingly poor health means patients might struggle to collect sufficient income to pay for their now added expenses, further causing them to struggle to pay for anything insurance might not cover, such as doctor ordered lab tests.

The affect this has on hospitals and medical laboratories casts light on the healthcare marketplace as a whole. It’s a trend that needs to be further studied.

“Most hospital bad debt is associated with insured patients, and nearly one in three hospitals report over $10M in bad debt,” are two of the top five financial healthcare statistics reported by Definitive Healthcare in a 2023 report.

“Expanding patient collection strategies may be key to maximizing revenue and avoiding losses,” TechTarget suggested.

Possible Solutions

The Commonwealth Fund study made clear that employer-covered healthcare does not guarantee affordable care or that ample care will be provided. Possible solutions from the study called on policymakers to “expand coverage and lower costs for consumers.” It added that “extending enhanced premium tax credits and strengthening protections against medical debt could make coverage more protective and affordable.”

Until a solution can be found, it’s wise to stay abreast of this trend and how it can impact the bottom line of clinical laboratories and anatomic pathology groups nationwide.

—Kristin Althea O’Connor

Related Information:

The State of Health Insurance Coverage in the U.S.

New Survey: Nearly One of Four Adults with Health Coverage Struggle with High Out-of-Pocket Costs and Deductibles; Majority of Underinsured in Employer Plans

One in Four Adults Are Underinsured: What Healthcare Leaders Should Know

Patient Collection Rate Falls to Nearly 48%

Paying for It: How Health Care Costs and Medical Debt Are Making Americans Sicker and Poorer

Insured Patients Account for More than Half of Bad Debts Written Off by Provider Organizations in 2023, According to Kodiak Solutions Analysis

Five Hospital Bad Debt Statistics You Need To Know

Microbiologist Writes Children’s Book on Becoming a Clinical Laboratory Scientist

Encouraging the next generation of clinical laboratorians could contribute to solving current staffing shortages in the nation’s medical laboratories

This holiday season brings an exciting new gift that will catch the attention of Dark Daily’s readers. It’s a children’s book that introduces young readers to working in clinical laboratories!

The book, titled, “I Want to be a Laboratory Scientist,” follows a girl named Kori who is working on a school project about her mother’s job as a microbiology clinical laboratory scientist.

“This is a steppingstone into the career of laboratory science, so we should share what we do with the world. Any lab scientist who has a child, niece, nephew, or grandchild in their life should give this gift. It could open an entirely new world of possibilities for them. It could make them excited for science,” said the book’s author Kelli Garcia, microbiology supervisor at Saint Francis Hospital and Medical Center, part of Trinity Health of New England, in an exclusive interview with Dark Daily.

“Most children have a small idea or image of what options are available in medicine or science—usually a doctor or nurse. They never see the people that work behind the scenes or different areas,” Garcia noted.

She penned her book with hopes of calling attention to medical fields beyond those most commonly seen by children, as she also had only learned about the field when she was graduating from college.

“I Want to be a Laboratory Scientist,” is now available at many major retailers, including Amazon and Barnes and Noble. (Graphic copyright: Kelli Garcia.)

Opening Children’s Eyes

Garcia’s journey took about four years from the moment she began writing to finally finding a publisher for her 36-page book that’s geared toward 6-8 year-olds. “I spent many hours writing and rewriting so it wouldn’t be too specific but also not too minimal that the point and purpose would be missed,” she said, adding that her daughter was her muse.

Garcia’s own children have excitedly brought the book to their schools and shared them with their local library. Such steps could help a field that is working hard to keep up with demand.

“There are so many ways to engage children in different areas of science as long as we make those areas known to them. They don’t all wants to be a doctor or nurse, but some still want to help in another way. This book will show them you can be in medicine helping people but behind the scenes—the unsung hero,” microbiologist and children’s book author Kelli Garcia (above) told Dark Daily. She added, “It will also make them aware that laboratory science is a rewarding career and show that it’s not just doctors and nurses who are involved in treating patients.” (Photo copyright: Kelli Garcia.)

Helping with Laboratory Staffing Shortages

“Over the decade, there are expected to be about 24,200 job openings each year, primarily due to the need to replace workers who retire or leave the field,” according to an American Society for Clinical Laboratory Science (ASCLS) news story. The organization also noted that recent data from the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) show that only 4,246 students graduated from medical laboratory scientist (MLS) programs and only 4,380 students graduated from medical laboratory technician (MLT) programs.

Those low numbers are not going unnoticed. The Medical Laboratory Personnel Shortage Relief Act of 2024, introduced in September by State Representative Deborah Ross (NC-02), was created to help bring a much-needed boost to the field. The Act brought in grants for clinical laboratory staff training in accredited institutions and added “medical laboratory professionals to the National Health Service Corps,” the ASCLS noted.

The ASCLS continues to encourage those working in clinical laboratories to make their voices heard on Capitol Hill to further support the field.

Hope is growing that more students will choose clinical laboratory work for their futures. Medical and clinical laboratory technologist was listed in Careers Fittest rankings of the top 14 careers to consider in 2024/2025. Careers Fittest cited an 11% job growth expected in the area by 2031.

It is a worthy objective to educate younger children about the career path of a clinical laboratory scientist and opportunities to work in microbiology laboratories. Perhaps Garcia’s new children’s book will help with that trend, and just in time for the holidays!

—Kristin Althea O’Connor

Related Information:

New Book Inspires Kids to Become Lab Scientists

Labvocate Action Alert: Medical Laboratory Personnel Shortage Relief Act Introduced in Congress

H.R.9849-Medical Laboratory Personnel Shortage Relief Act of 2024

The Best Careers for the Future: 14 High-Growth Jobs (2024–2025 and Beyond)

Microbiology: What is a Clinical Laboratory Scientist?

American Board of Pathology Admits to Mistakenly Failing 78 Students

Incorrect results spanned exams from 2022-2024 with those students affected by this situation stunned by ABPath’s admission

There are always young anatomic pathologists who experience the heartache of failing board exams. Failing, after all, is part of the education process. But how disheartening would it be to learn years later that you actually passed those exams? For about 70 pathology students that’s exactly what happened.

On October 3, the American Board of Pathology (ABPath) announced that “a small percentage” of students were told they had failed an exam when they had not, MedPage Today reported. The test dates ranged from 2022 to 2024 and affected 76 students out of 4,059.

In its official statement, ABPath wrote that it had “recently conducted a reassessment and rescoring of the Primary and Subspecialty certification examinations. In doing so, ABPath identified that a small percentage of candidates (less than 2%) actually met the passing score requirements that were previously scored as slightly below the passing score threshold.”

The organization added, “The impacted candidates have all been notified. Those candidates received a passing score for their respective certification examination and will receive a refund of their application fee, as well as any fees paid toward subsequent examinations. Impacted training programs will be receiving notifications soon.”

According to MedPage Today, which received a copy of the email from a pathology student, “ABPath’s email to affected test takers was brief, explaining that a reassessment of the anatomic pathology certification examination ‘disclosed that your score exceeded the cut-score threshold for a passing score, rather than being slightly below it.’”

Many pathology students were stunned by ABPath’s admission and went to message boards to vent their frustration.

“Failing a major board hits you hard especially after so many years of training and so much time spend on studying. This situation was a shock, a disappointment, and a betrayal,” one former student identified as Idfcwytas wrote on Reddit concerning ABPath’s revelation, MedPage Today reported.

In its coverage of the ABPath announcement, MedPage Today wrote, “Bryan Carmody, MD (above), of Eastern Virginia Medical School in Norfolk, who blogs frequently about medical education issues, said that a situation like this decreases trust in the boards themselves, and that being mistakenly failed has financial and career impacts. For instance, he said, ‘many hospitals require board certification to get hospital privileges or to work there … so if you were applying to an academic job or something, I think it’s going to hurt your application.’” Anatomic pathologists understand clearly how lack of board certification affects their career goals. (Photo copyright: Eastern Virginia Medical School.)

ABPath’s Response and the Impact on Students

An ABPath spokesperson told MedPage Today, “We understand how significant this is to our candidates and diplomats and are committed to working closely with those impacted. ABPath has also implemented improvements to our processes to prevent this issue in the future.”

No details were disclosed on what changes would be made going forward, MedPage Today noted. As a result of the mistake, ABPath refunded exam fees and offered affected testers updated certificates and letters showing the proper results.

Some declared that response does not go far enough. Many claimed ABPath’s efforts lack adequate financial compensation as well as genuine compassion.

Reddit user walleyealx wrote, “The mistake definitely cost me LOTS of time, mental anguish, and money. Please note, there was no apology at all in these emails, which makes me even more angry,” MedPage Today reported.

Several days after the initial email, ABPath offered an apology “for the frustration this has caused,” according to MedPage Today.

No Recourse for Failing Grades

ABPath’s website notes that failed exams cannot be appealed. This means that any students doubting their scores during those years would not have been able to challenge the results.

“Even if the board offers a refund for the exams, it hardly makes up for the time, money, and lost career opportunities these individuals have had to deal with,” noted the Lento Law Firm in a blog post following ABPath’s announcement.

The firm added, “This incident only affected about 2% of exam takers from 2022 to 2024, but it’s a significant issue for these people. Not getting board certification can mean no hospital privileges, which can prevent you from obtaining certain jobs. Failing to get a certain specialty certification can also mean a $30,000 difference in your paycheck. Pathologists have only five years and 10 tries to pass the exam, which costs between $2,100 and $2,600 each time. Re-taking the exam after getting a failing score, therefore, represents a significant financial investment—not to mention the time spent studying.”

Implications of failure can be profound, but mistakes happen. ABPath appears to be taking steps to prevent similar mistakes in the future. Hopefully, the organization will also find a way to make whole those affected by its error.

—Kristin Althea O’Connor

Related Information:

Dozens Who Were Told They Failed the Pathology Board Exam Actually Passed

Reassessment and Rescoring of ABPath Primary and Subspecialty Certification Examinations

ABPath Appeals Procedure

The Pathology Board Failed 76 Exam Takers by Mistake

UCLA Spinoff Develops AI Tool That Improves Accuracy of Prostate Cancer Assessments

Software analyzes imaging scans and clinical laboratory data to help oncologists and anatomic pathologists visualize a tumor’s extent

Anatomic pathologists understand that, along with breast cancer, diagnostic testing for prostate cancer accounts for a high volume of clinical laboratory tests. Thus, a recent study indicating that a new artificial intelligence (AI)-based software tool can dramatically improve physicians’ ability to identify the extent of these cancers will be of interest.

The software, known as Unfold AI, was developed by Avenda Health, a University of California Los Angeles (UCLA) spinoff company. Unfold AI, according to Avenda, predicts focal therapy success by an increase of 77% over standard methods.

“The study found that Unfold AI’s patient-specific encapsulation confidence score (ECS), which is generated based on multiple patient data points, including MRI scans, biopsy results, PSA [prostate-specific antigen] data, and Gleason scores, is critical for predicting treatment success,” an Avenda press release states. “These findings emphasize the importance of Unfold AI’s assessment of tumor margins in predicting treatment outcomes, surpassing the predictive capability of conventional parameters.”

“Unfold AI’s ability to identify tumor margins and provide the ECS will improve treatment recommendations and allow for less-invasive interventions,” said study co-author Wayne Brisbane, MD, a urologic oncologist and UCLA medical professor, in another press release. “This more comprehensive approach enhances our ability to predict treatment outcomes and tailor interventions effectively to individual patient needs.”

The UCLA researchers published their findings titled, “Artificial Intelligence Improves the Ability of Physicians to Identify Prostate Cancer Extent,” in The Journal of Urology. Results were also presented at the 2024 American Urological Association annual meeting.

“This study is important because it shows the ability of AI to not only replicate expert physicians, but to go beyond human ability,” said study co-author Wayne Brisbane, MD (above), a urologic oncologist and UCLA medical professor, in a press release. “By increasing the accuracy of cancer identification in the prostate, more precise and effective treatment methods can be prescribed for patients.” Clinical laboratories that work with anatomic pathologists to diagnose prostate and other cancers may soon have a new AI testing tool. (Photo copyright: UCLA.)

How Unfold AI Works

To gauge the extent of prostate tumors, surgeons typically evaluate results from multiple diagnostic methods such as PSA tests and imaging scans such as MRIs, according to a UCLA press release. However some portions of a tumor may be invisible to an MRI, causing doctors to underestimate the size.

Unfold AI, originally known as iQuest, was designed to analyze data from PSA, MRI, fusion biopsy, and pathology testing, according to a company brochure. From there, it generates a 3D map of the cancer. Avenda’s website says the technology provides a more accurate representation of the tumor’s extent than conventional methods.

“Accurately determining the extent of prostate cancer is crucial for treatment planning, as different stages may require different approaches such as active surveillance, surgery, focal therapy, radiation therapy, hormone therapy, chemotherapy, or a combination of these treatments,” Brisbane said in the UCLA press release.

Putting AI to the Test

In the new study, the UCLA researchers enlisted seven urologists and three radiologists to review 50 prostate cancer cases. Each patient had undergone prostatectomy—surgical removal of all or part of the prostate—but might have been eligible for focal therapy, a less-aggressive approach that uses heat, cryotherapy, or electric shocks to attack cancer cells more selectively.

The physicians came from five hospitals and had a wide range of clinical experience from two to 23 years, the researchers noted in The Journal of Urology.

They reviewed clinical data and examined MRI scans of each patient, then “manually drew outlines around the suspected cancerous areas, aiming to encapsulate all significant disease,” the press release states. “Then, after waiting for at least four weeks, they reexamined the same cases, this time using AI software to assist them in identifying the cancerous areas.”

The researchers analyzed the physicians’ work, evaluating the accuracy of the cancer margins and the “negative margin rate,” indicating whether the clinicians had identified all of the cancerous tissue. Using conventional approaches, “doctors only achieved a negative margin 1.6% of the time,” the press release states. “When assisted by AI the number increased to 72.8%.”

The clinicians’ accuracy was 84.7% when assisted by AI versus 67.2% to 75.9% for conventional techniques.

They also found that clinicians who used the AI software were more likely to recommend focal therapy over more aggressive forms of treatment.

“We saw the use of AI assistance made doctors both more accurate and more consistent, meaning doctors tended to agree more when using AI assistance,” said Avenda Health co-founder and CEO Shyam Natarajan, PhD, who was senior author of the study.

“These results demonstrate a marked change in how physicians will be able to diagnose and recommend treatment for prostate cancer patients,” said Natarajan in a company press release. “By increasing the confidence in which we can predict a tumor’s margins, patients and their doctors will have increased certainty that their entire tumor is treated and with the appropriate intervention in correlation to the severity of their case.”

Already Cleared by FDA

Avenda received FDA 510(k) clearance for Unfold AI in November 2022. On July 1, 2024, the American Medical Association (AMA) implemented a CPT [Current Procedural Terminology] Category III code for the software, enabling insurance reimbursement for services that employ the technology, the company said in a press release.

The AMA describes CPT Category III as “a temporary set of codes for emerging technologies, services, procedures, and service paradigms.”

In the same press release, Avenda revealed that the federal Centers for Medicare and Medicaid Services (CMS) had assigned a national payment rate for Unfold AI.

UCLA’s study found that AI can outperform doctors both in sensitivity (a higher detection rate of positive cancers) and specificity (correctly detecting the sample as negative). That’s relevant and worth watching for further developments.

Pathologists and clinical laboratory managers should consider this use of AI as one more example of how artificial intelligence can be incorporated into diagnostic tests in ways that allow medical laboratory professionals to diagnose disease earlier and more accurately. This will improve patient care because early intervention for most diseases leads to better outcomes.

—Stephen Beale

Related Information:

New Study Proves AI Enhances Physicians’ Ability to Identify Prostate Cancer Extent with 84 Percent Accuracy

New Study Demonstrates Avenda Health’s Unfold AI to Better Predict Focal Therapy Success by 77% as Compared to Standard Methods

AI Model May Yield Better Outcomes for Prostate Cancer

Artificial Intelligence Improves the Ability of Physicians to Identify Prostate Cancer Extent

Artificial Intelligence Detects Cancer with 25% Greater Accuracy than Doctors in UCLA Study

Study Finds Unfold AI Better Predicts Focal Therapy Success in Prostate Cancer Patients

First AI-Powered Precision Oncology Platform for Prostate Cancer Care, iQuest Receives FDA Clearance

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