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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

Coming Wave of Retirees Predicted to Trigger ‘Silver Tsunami’ That Will Drive Changes in How Hospitals Deliver Care

Clinical laboratories will need new methods for accommodating the increase in senior patients seeking rapid access to medical laboratory testing and pathology services

Experts within the healthcare industry are predicting existing care delivery models will need to be revised within the next few years to accommodate a rapidly aging population dubbed a “silver tsunami.” Many hospital systems are actively taking steps to prepare for this coming sharp increase in the number of senior citizens needing healthcare services, including clinical laboratory testing. 

Multi-hospital health systems will have to accommodate demand for healthcare delivered in ways that meet the changing expectations of seniors. These include rapid access to clinical laboratory testing and anatomic pathology services, electronic health records, and telehealth visits with their doctors.

These trends will also require clinical laboratories to evolve in ways consistent with meeting both the volume of services/testing and improved levels of personal, speedy access to test results that seniors expect.

All of this is problematic given the current state of hospital staff shortages across the nation.

“In this environment, coupled with lowering revenues, staffing shortages and higher expenses, healthcare is being forced from an abundance mindset to one of scarcity,” Jonathan Washko, MBA, FACPE, NRP, AEMD, director at large, National Association of Emergency Medical Technicians (NAEMT) and assistant vice president, CEMS Operations, told Becker’s Hospital Review.

Investopedia defines the term “silver tsunami” as “the demographic shift caused by the increasing number of older adults in society, led by the baby boom generation.”

Baby boomers are individuals who were born between 1946 and 1964. The US Census Bureau estimates there are 76.4 million baby boomers living in the country today, and that by 2030 all boomers will be 65 years of age or older.

“In the next five years, the most significant disruptor to healthcare will be the capacity challenges associated with the ‘silver tsunami’ of baby boomers hitting the age of healthcare consumption,” said Jonathan Washko, MBA, FACPE, NRP, AEMD (above), director at large, National Association of Emergency Medical Technicians (NAEMT) and assistant vice president, CEMS Operations, in an interview with Becker’s Hospital Review. Clinical laboratories will have to engage with these senior patients in new ways that fit their lifestyles. (Photo copyright: EMS1.)

Silver Tsunami Could Transform Healthcare

Approximately 10,000 people turn 65 in the US every day, making them eligible for Medicare. This increase in recipients is likely to strain the government system. Healthcare organizations are seeking new ways to prepare for the anticipated boost in seniors requiring health services. 

Washko believes the population shift will cause healthcare leaders to develop novel care models based on “intelligent and intentional design for better outcomes, lower costs, and faster results,” Becker’s Hospital Review reported.

“Solutions will require shifts to care in the home, new operational care models, and technology integration,” Washko noted. “These will allow the medicine being delivered to be effectively and efficiently optimized, vastly improving the productivity of existing and net new capacity.”

A recent HealthStream blog post outlined some of the methods hospitals can use to adapt to an aging population. They include:

  • Facility Design: Modifying lighting, using large-print signage, providing reading glasses and hearing amplifiers, purchasing taller chairs with arms and lower examination tables.
  • Technology: Offering assistive devices, creating more telehealth options, developing more user-friendly websites and electronic medical records.
  • Healthcare Delivery: Training staff on geriatric care, offering services intended for an older population, such as geriatric psychology, fall prevention programs, and establishing a more patient-centered environment. 

Government Healthcare Changes

There are also looming coverage changes for Medicare recipients as the federal Centers for Medicare and Medicaid Services (CMS) plans to transition from fee-for-service models to value-based models to lower government healthcare expenses.

“Anticipated regulatory challenges post-election will influence healthcare operations. The looming recession may alter how individuals access healthcare and treatment based on affordability,” Shelly Schorer, CFO CommonSpirit Health, told Becker’s Hospital Review. “Despite these headwinds and challenges, at CommonSpirit we are prepared to pivot and meet the changing needs of our communities by accurately predicting and addressing their healthcare needs efficiently.”

“This represents the greatest market disruption on the near-horizon,” said Ryan Nicholas, MD, Chief Quality Officer at Mercy Medical Group. “This has prompted Mercy Medical Group to move rapidly into value-based care with focus on total cost of care and network integrity.”

Nichols told Becker’s Hospital Review that Mercy’s Medicare population has increased by 24% over the last year, and that Mercy is anticipating a growth of 28% over the next year. These increases have convinced the organization to shift its view of service functions and to invest in additional resources that meet the growing demands for senior healthcare.

“Expanding ambulatory services and improving access for primary care services to reduce unnecessary [emergency department] utilization and shorten length of stay is our top priority,” Nichols said.

Shifting Demand for Clinical Laboratory Testing

This is not the first time Dark Daily has covered how shifting demographics are changing the landscape of healthcare services in nations where populations are aging faster than babies are being born.

In “Demographic Shift Means Lower Birthrates and Aging Populations around the World, Suggesting Big Changes for Global Healthcare, Pathology Groups, and Clinical Laboratories,” we reported how having fewer pediatric patients and more senior citizens is fundamentally altering what types of tests are in greatest demand from medical laboratories worldwide.

Thus, many healthcare organizations are taking a proactive approach to the expected increase in seniors needing care for age-related and chronic illnesses.

“This along with other risk and value-based models will continue to drive integration of healthcare services and the value proposition through improving quality while reducing costs,” Alon Weizer, MD, chief medical officer and senior vice president, Mount Sinai Medical Center, Miami Beach, Fla., told Becker’s Hospital Review. “While we are investing heavily to be successful in these models through primary care expansion and technology that will help reduce the need for acute care services, we continue to focus our culture on providing safe and high quality care to our patients.”

Clinical laboratories will need to adapt to the changing needs of older patients to ensure all people receive high quality care. The coming “silver tsunami” will require labs to evolve in ways consistent with meeting the growing needs of seniors and providing better levels of personal services and access to cost-effective, fast, and accurate lab testing.

—JP Schlingman

Related Information:

Health Systems Brace for the ‘Silver Tsunami’

Overcoming the ‘Silver Tsunami’

‘Silver Tsunami’: Challenges and Opportunities of an Aging Population

How Will the Silver Tsunami Affect Non-Acute Care?

Is Your Hospital Ready for the “Silver Tsunami”?

Silver Tsunami: Can Our Healthcare System Adapt to Aging Population and Mental Health Challenges?

Demographic Shift Means Lower Birthrates and Aging Populations Around the World, Suggesting Big Changes for Global Healthcare, Pathology Groups, and Clinical Laboratories

Protesters Outside UnitedHealthcare Headquarters Allege Company Systemically Denies Care

Are ongoing protests and federal investigations into health plan practices evidence that customers have reached a tipping point?

It is not common for beneficiaries to get arrested in front of their health plan’s headquarters. But that is what happened in July, when protesters gathered outside of UnitedHealth Group (UHG) in Minnetonka, Minn., to stress their dissatisfaction with the health insurer. More than 150 protesters participated in the demonstration. Eleven were arrested and charged with misdemeanors for blocking the public street outside of the headquarters.

Their main complaint is that the insurer systemically denies care for patients. This is a situation that probably resonates with hospitals, physicians, clinical laboratory professionals, and pathologists, who often see their own claims denied by health plans, including UnitedHealthcare. 

“UnitedHealth Group’s profiteering by denying care is a disgrace, leaving people across Minnesota and all of the United States without the care they desperately need,” wrote members of the People’s Action Institute in a letter to UHG’s CEO Sir Andrew Witty. People’s Action organized the protest as part of its Care Over Cost campaign.

“Health insurance coverage has expanded in America, but we are finding it is private health insurance corporations themselves that are often the largest barrier for people to receive the care they and their doctor agree they need,” Aija Nemer-Aanerud, campaign director with People’s Action told CBS News.

“We have asked UnitedHealthcare for systemic changes in their practices and they have refused,” he told Bring Me The News.

Nemer-Aanerud told CBS News that UnitedHealth Group leadership has “refused to acknowledge that prior authorizations and claim denials are a widespread problem.”

“Our mission is to help people live healthier lives and help make the health system work better for everyone,” said UnitedHealth Group CEO Sir Andrew Witty (above) during a Senate Finance Committee hearing in May, NTD reported. “Together, we are working to help enable our health system’s transition to value-based care and are empowering physicians and their care teams to deliver more personalized, high-quality care that delivers better outcomes at a lower cost.” (Photo copyright: The Business Journals.)

People’s Action Institute Demands

In the letter, the changes People’s Action urged UHG to make include:

  • Ceasing to deny claims for treatments recommended by medical professionals.
  • Overturning existing denials for recommended treatments.
  • Stopping the practice of using Artificial Intelligence (AI) and algorithms to deny claims in bulk.
  • Executing a publicly shared audit and reimbursing federal/state governments for public money diverted by claims and prior-authorization denials within Medicare and Medicaid systems.
  • Expediting payment of claims.
  • Making public the details of denied claims and prior authorizations by market, plan, state, geography, gender, disability and race.

A spokesperson for UnitedHealth Group told CBS News that the company has had several talks with People’s Action and has settled some of the organization’s issues. That spokesperson also confirmed that UHG tried to discuss specific cases, but the issues People’s Action brought up had already been resolved.

“The safety and security of our employees is a top priority. We have resolved the member-specific concerns raised by this group and remain open to a constructive dialogue about ensuring access to high-quality, affordable care,” UnitedHealthcare said in a statement.

Profits over Patients?

The People’s Action Institute is a national network of individuals and organizations who strive to help people across the US overturn medical care denials made by insurance giants. Its Care Over Cost campaign aims to influence insurers to initiate systemic changes in their practices. 

The recent protest occurred as UnitedHealth Group released its second-quarter financial report claiming $7.9 billion in profits. The company provides health insurance for more than 47 million people across the country and took in $22.4 billion in profits last year.

“UnitedHealth Group’s $7.9 billion quarterly profit announcement is the result of a business model built on pocketing premiums and billions of dollars in public funds, then profiting by refusing to authorize or pay for care,” said Nemer-Aanerud in a press release. “People should not have to turn to public petitions or direct actions to get UnitedHealthcare to pay for the care they need to live.”

“UnitedHealth Group made a decision to spend billions of dollars on stock buybacks, lobbying, and executive pay instead of paying for care people need,” Nemer-Aanerud told Bring Me The News. “They are harming people for profit and should be held accountable for that choice.”

“Delays and denials of care hurt millions of people every year and result in ongoing sickness, injury, medical debt, bankruptcy, worsened health outcomes and even premature death,” wrote Christy Atkinson, MD, a family physician with M Health Fairview University of Minnesota Medical Center and chair of Physicians for a National Health Program-Minnesota; and Matt Hoffman, MD, a physician at Allina Health Vadnais Heights Clinic and a member of Doctors Council, the country’s oldest and largest union of attending physicians, in an article they penned for Minnesota Reformer following a meeting with UHG concerning the protests.

“We all pay for this convoluted system, whether it is in our health insurance premiums or in our public programs. UnitedHealth Group is making billions of dollars in profit by denying people care, including in privatized Medicare and Medicaid plans, to the point that it has prompted a federal investigation … Still, we left the meeting with hope,” they added.

Protests like this one against UnitedHealth Group serve as evidence that the current system of commercial health insurance plans could be deteriorating. This descent may cause customers of these plans to take unprecedented actions to fight for necessary medical care.

As noted earlier, hospitals, physician groups, clinical laboratories, and anatomic pathology groups that see their own claims often denied by health insurers without a clear reason for the denials are probably sympathetic to the plight of patients who are frustrated with how UnitedHealthcare denies their access to care.

—JP Schlingman

Related Information:

11 Arrested During Protest at UnitedHealthcare HQ, Alleging Company is Systemically “Refusing to Approve Care”

Protesters Arrested Outside of UnitedHealth Group Headquarters in Minnetonka

People’s Action Institute Statement on UnitedHealth Group $7.9 Billion Profit Report Following Arrests at Headquarters

Copy of Demand Letter for Delivery (United Healthcare) April 2024

Doctors Speak: Inside Our Meeting with UnitedHealth Group

UnitedHealth Reports $7.9 Billion in Q2 Profits after Protesters Arrested

Arrests Made During Protest Outside UnitedHealthcare Headquarters

11 Protesters Arrested Outside UnitedHealth Group Headquarters

In Massive Crackdown, US Department of Justice Charges 193 Defendants with $2.75 Billion in Healthcare Fraud

Charges include $1.1 billion in alleged telemedicine and fraudulent clinical laboratory testing

Nearly 200 individuals in 25 states are facing charges for alleged participation in a variety of healthcare frauds, the US Department of Justice (DOJ) announced in a press release. This major enforcement action involves telemedicine and clinical laboratory testing as well as other healthcare schemes. In total, the DOJ is alleging the defendants are responsible for $2.75 billion in intended losses and $1.6 billion in actual losses.

The charges include:

  • $1.1 billion in alleged telemedicine and clinical laboratory fraud.
  • A $900 million scheme involving fraudulent Medicare billing for amniotic wound grafts.
  • Unlawful distribution of Adderall and other stimulants.
  • A $90 million scheme involving distribution of “adulterated and misbranded HIV medication.”
  • More than $146 million in fraud involving addiction treatment schemes.
  • A variety of schemes involving fraudulent billing for durable medical equipment (DME) products.

This is one of the DOJ’s largest fraud enforcement actions to date. The charges follow investigations by the Department of Health and Human Services Office of Inspector General (OIG), the Federal Bureau of Investigations (FBI), the Drug Enforcement Administration (DEA), and other federal and state law enforcement agencies, the government said. Most defendants are facing charges in federal court, but some cases are being prosecuted in state courts.

As part of the action, the government has seized more than $231 million in assets, including cash, luxury vehicles, and gold.

Monica Cooper, JD (above), a DOJ trial attorney and member of the Texas Strike Force, is one of two attorneys prosecuting the case against Harold Albert “Al” Knowles of Delray Beach, Fla., and Chantal Swart of Boca Raton, Fla., in the DOJ’s latest crackdown on healthcare fraud. Charges against Knowles and Swart include conspiracy to commit healthcare fraud, conspiracy to defraud the United States, and paying/receiving healthcare kickbacks in a $359 million scheme to bill Medicare for medically unnecessary genetic tests at two Houston clinical laboratories. (Photo copyright: US Department of Justice.)

Houston-Area Labs Charged in $359 Million Scheme

In one case, the government charged Florida residents Harold Albert “Al” Knowles and Chantal Swart in a $359 million scheme involving fraudulent Medicare billing for medically unnecessary genetic tests. Knowles owned two Houston-area labs—Bio Choice Laboratories, Inc. and Bios Scientific, LLC—while Swart ran a telemarketing operation. According to DOJ case summaries, the government alleges that Knowles paid kickbacks to Swart to obtain DNA samples and doctors’ orders for tests.

“Knowles, Swart, and others obtained access to tens of thousands of beneficiaries across the United States by targeting them with deceptive telemarketing campaigns,” the indictments allege. “Call center representatives—who were almost never medical professionals—often prompted beneficiaries to disclose their medical conditions and induced them to agree to genetic testing regardless of medical necessity.”

In addition, “Knowles, Swart, and others agreed that Swart and others would pay illegal kickbacks and bribes to purported telemedicine companies to obtain signed doctors’ orders for genetic testing after only a brief telemedicine visit,” the indictment stated. “Knowles and his co-conspirators knew that the purported telemedicine companies’ physicians were rarely, if ever, the beneficiaries’ treating physicians and rarely, if ever, used the genetic testing results in the beneficiaries’ treatment.”

Dallas-Area Labs Charged in $335 Million Scheme

In another case, the federal government charged that the owner of two Dallas-area clinical laboratories engaged in a $335 million Medicare billing scheme.

Keith Gray, owner of Axis Professional Labs, LLC and Kingdom Health Laboratory, LLC, “offered and paid kickbacks to marketers in exchange for their referral to Axis and Kingdom of Medicare beneficiaries’ DNA samples, personally identifiable information (including Medicare numbers), and signed doctors’ orders authorizing medically unnecessary cardio genetic testing,” the government alleged. “As part of the scheme, the marketers engaged other companies to solicit Medicare beneficiaries through telemarketing and to engage in ‘doctor chase,’ i.e., to obtain the identity of beneficiaries’ primary care physicians and pressure them to approve genetic testing orders for patients who purportedly had already been ‘qualified’ for the testing.”

The indictment, filed in the US District Court for the Northern District of Texas, noted that cardio, or cardiovascular tests, are designed to assess a patient’s risk of developing cardiovascular diseases or assist in treatment.

Other Clinical Laboratory and Healthcare Fraud Cases

DOJ attorneys charged the owners of Innovative Genomics, a clinical laboratory in San Antonio, in a $65 million scheme to bill Medicare and the COVID-19 Uninsured Program for “medically unnecessary and otherwise non-reimbursable COVID-19 and genetic testing,” according to the indictment. Also charged were two patient recruiters who allegedly received kickbacks for referring patients.

Richard Abrazi of New York City was charged in a $60 million Medicare billing scheme. Abrazi owned two clinical laboratories: Enigma Management Corp. and Up Services Inc. Both operated as Alliance Laboratories.

“Abrazi and others engaged in a scheme to pay and receive kickbacks and bribes in exchange for laboratory tests, including genetic tests, that Enigma and Up billed to Medicare,” the indictment alleges. “Abrazi and others also allegedly paid and received kickbacks and bribes in exchange for arranging for the ordering of medically unnecessary genetic tests that were ineligible for Medicare reimbursement.”

The DOJ charged Brian Cotugno, of Auburn, Ga., and James Matthew Thorton “Bo” Potter, of Santa Rosa Beach, Fla., in a $20 million Medicare billing scheme. Cotugno, the indictment alleges, sold Medicare Beneficiary Identification Numbers (BINs) to two Alabama laboratories co-owned by Potter.

“The BINs were used to bill Medicare tens of millions of dollars for OTC COVID-19 test kits, many of which had not been requested by the beneficiaries,” the government alleged.

These are only a few of the recent cases the DOJ brought against defendants nationwide for healthcare, telemedicine, and clinical laboratory fraud. Both Dark Daily and our sister publication The Dark Report have covered these ongoing investigations for years. And we will continue to do so because it’s important that lab managers and pathology group leaders are aware of the lengths to which the DOJ is pursuing bad actors in healthcare.

—Stephen Beale

Related Information:

National Health Care Fraud Enforcement Action Results in 193 Defendants Charged and Over $2.75 Billion in False Claims

2024 National Health Care Fraud Enforcement Action Summary of Criminal Charges

2024 National Health Care Fraud Enforcement Action Court Documents

Clinical Laboratory Testing Implicated in National Healthcare Fraud Sting

Almost 200 People Charged in Schemes Totaling $2.7B in False Health Care Claims

DOJ Catches Over $2.7B in Healthcare Fraud Schemes

Preparing for Z-Codes as DEX Genetic Testing Registry Rolls Out to Commercial Health Plans

Palmetto GBA’s Chief Medical Officer will cover how clinical laboratories billing for genetic testing should prepare for Z-Codes at the upcoming Executive War College in New Orleans

After multiple delays, UnitedHealthcare (UHC) commercial plans will soon require clinical laboratories to use Z-Codes when submitting claims for certain molecular diagnostic tests. Several private insurers, including UHC, already require use of Z-Codes in their Medicare Advantage plans, but beginning June 1, UHC will be the first to mandate use of the codes in its commercial plans as well. Molecular, anatomic, and clinical pathologist Gabriel Bien-Willner, MD, PhD, who oversees the coding system and is Chief Medical Officer at Palmetto GBA, expects that other private payers will follow.

“A Z-Code is a random string of characters that’s used, like a barcode, to identify a specific service by a specific lab,” Bien-Willner explained in an interview with Dark Daily. By themselves, he said, the codes don’t have much value. Their utility comes from the DEX Diagnostics Exchange registry, “where the code defines a specific genetic test and everything associated with it: The lab that is performing the test. The test’s intended use. The analytes that are being measured.”

The registry also contains qualitative information, such as, “Is this a good test? Is it reasonable and necessary?” he said.

Bien-Willner will answer those questions and more at the upcoming annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans on April 30-May 1. Lab professionals still have time to register and attend this important presentation.

Molecular, anatomic, and clinical pathologist Gabriel Bien-Willner, MD, PhD (above), Palmetto GBA’s Chief Medical Officer, will speak about Z-Codes and the MolDX program during several sessions at the upcoming Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management taking place in New Orleans on April 30-May 1. Clinical laboratories involved in genetic testing will want to attend these critical sessions. (Photo copyright: Bien-Willner Physicians Association.)

Palmetto GBA Takes Control

Palmetto’s involvement with Z-Codes goes back to 2011, when the company established the MolDX program on behalf of the federal Centers for Medicare and Medicaid Services (CMS). The purpose was to handle processing of Medicare claims involving genetic tests. The coding system was originally developed by McKesson, and Palmetto adopted it as a more granular way to track use of the tests.

In 2017, McKesson merged its information technology business with Change Healthcare Holdings LLC to form Change Healthcare. Palmetto GBA acquired the Z-Codes and DEX registry from Change in 2020. Palmetto GBA had already been using the codes in MolDX and “we felt we needed better control of our own operations,” Bien-Willner explained.

In addition to administering MolDX, Palmetto is one of four regional Medicare contractors who require Z-Codes in claims for genetic tests. Collectively, the contractors handle Medicare claims submissions in 28 states.

Benefits of Z-Codes

Why require use of Z-Codes? Bien-Willner explained that the system addresses several fundamental issues with molecular diagnostic testing.

“Payers interact with labs through claims,” he said. “A claim will often have a CPT code [Current Procedural Technology code] that doesn’t really explain what was done or why.”

In addition, “molecular diagnostic testing is mostly done with laboratory developed tests (LDTs), not FDA-approved tests,” he said. “We don’t see LDTs as a problem, but there’s no standardization of the services. Two services could be described similarly, or with the same CPT codes. But they could have different intended uses with different levels of sophistication and different methodologies, quality, and content. So, how does the payer know what they’re paying for and whether it’s any good?”

When the CPT code is accompanied by a Z-Code, he said, “now we know exactly what test was done, who did it, who’s authorized to do it, what analytes are measured, and whether it meets coverage criteria under policy.”

The process to obtain a code begins when the lab registers for the DEX system, he explained. “Then they submit information about the test. They describe the intended use, the analytes that are being measured, and the methodologies. When they’ve submitted all the necessary information, we give the test a Z-Code.”

Then, the test undergoes a technical assessment. Bien-Willner described this as a risk-based process where complex tests, such as those employing next-generation sequencing or gene expression profiling, get more scrutiny than less-complex methodologies such as a polymerase chain reaction (PCR) test.

The assessment could be as simple as a spreadsheet that asks the lab which cancer types were tested in validation, he said. On the other end of the scale, “we might want to see the entire validation summary documentation,” he said.

Commercial Potential

Bien-Willner joined the Palmetto GBA in 2018 primarily to direct the MolDX program. But he soon saw the potential use of Z-Codes and the DEX registry for commercial plans. “It became instantly obvious that this is a problem for all payers, not just Medicare,” he said.

Over time, he said, “we’ve refined these processes to make them more reproducible, scalable, and efficient. Now commercial plans can license the DEX system, which Z-Codes are a part of, to better automate claims processing or pre-authorizations.”

In 2021, the company began offering the coding system for Medicare Advantage plans, with UHC the first to come aboard. “It was much easier to roll this out for Medicare Advantage, because those programs have to follow the same policies that Medicare does,” he explained.

As for UHC’s commercial plans, the insurer originally planned to require Z-Codes in claims beginning Aug. 1, 2023, then pushed that back to Oct. 1, according to Dark Daily’s sister publication The Dark Report.

Then it was pushed back again to April 1 of this year, and now to June 1.

“The implementation will be in a stepwise fashion,” Bien-Willner advised. “It’s difficult to take an entirely different approach to claims processing. There are something like 10 switches that have to be turned on for everything to work, and it’s going to be one switch at a time.”

For Palmetto GBA, the commercial plans represent “a whole different line of business that I think will have a huge impact in this industry,” he said. “They have the same issues that Medicare has. But for Medicare, we had to create automated solutions up front because it’s more of a pay and chase model,” where the claim is paid and CMS later goes after errors or fraudulent claims.

“Commercial plans in general just thought they could manually solve this issue on a claim-by-claim basis,” he said. “That worked well when there was just a handful of genetic tests. Now there are tens of thousands of tests and it’s impossible to keep up.

They instituted programs to try to control these things, but I don’t believe they work very well.”

Bien-Willner is scheduled to speak about Palmetto GBA’s MolDX program, Z-Codes, and related topics during three sessions at the upcoming 29th annual Executive War College conference. Clinical laboratory and pathology group managers would be wise to attend his presentations. Visit here (or paste this URL into your browser: https://www.executivewarcollege.com/registration) to learn more and to secure your seat in New Orleans.

—Stephen Beale

Related Information:

Palmetto Issuing ‘Z-Codes’ to Track Molecular Dx Utilization, Gather Data CPT Codes Can’t Provide

McKesson and Change Healthcare Complete the Creation of New Healthcare Information Technology Company

UnitedHealthcare Commercial: Reimbursement Policy Update Bulletin: January 2024

UnitedHealthcare’s Z-Code Requirement for Genetic Testing Claims Impacts Laboratories and Payers

UHC Delays April 1st Z-Code Commercial Implementation to June 1, 2024

UHC Will Delay Enforcement of Z-Codes for Genetic Test Claims

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