Book provides detailed road map for clinical laboratory professionals who believe they have a valid case to file under the federal qui tam statute, as well as lab owners who want to understand what motivates whistleblowers and what practices to avoid
Several high-profile whistleblower cases uncovering massive fraud have shocked the clinical laboratory industry over the past decade. Media coverage nearly always focuses on the court battle and subsequent renderings of justice. But little is written about what it is like to be a whistleblower who wants to hold a medical laboratory accountable for alleged violations of federal and state laws.
Now, a new “tell-all” book penned by Chris Riedel, a whistleblower who owned a clinical laboratory company in California, details the exploits of clinical laboratory whistleblowers over the past 15 years. The intriguing white-collar crime thriller, titled, “Blood Money: One Man’s Bare-Knuckle Fight to Protect Taxpayers from Medical Fraud,” outlines Riedel’s battle with major clinical laboratory players—including the so-called “Blood Brothers” Labcorp (NYSE:LH) and Quest Diagnostics (NYSE:DGX)—to expose medical laboratory fraud.
‘Most Whistleblowers Get Absolutely Destroyed’
The book takes the reader on a gripping journey into extortion, money laundering, attempted murder, buried gold in a CEO’s backyard, fraudsters hiding money in the Cayman Islands, and, according to the author, an Assistant Attorney General sabotaging her own state’s case and a corrupt state Governor who undermined litigation by his own Attorney General.
“I wrote it to be a true crime thriller, so I’m hoping people who love thrillers will enjoy it as a true crime story,” Riedel said in an exclusive interview with Dark Daily. “For anyone who’s considering filing a whistleblower lawsuit, this is an absolute must read.
“Most whistleblowers get absolutely destroyed,” he explained. “When companies find out who’s trying to attack their business model, they do everything they can to destroy the whistleblower’s life. Many end up bankrupt, unemployable, and divorced.
“There are things you can do to protect yourself and I list those in my rules for whistleblowers. I hope enough people will read it—particularly in Congress and maybe the Department of Justice (DOJ)—to put pressure on the DOJ to change their behavior. They are far too willing to accept what they call ‘affordable civil settlements’ as opposed to punishing companies and people for their theft,” Riedel said.
Chris Riedel (above) has worked in the healthcare industry as an executive and an entrepreneur for more than 40 years. He founded five companies, including two medical laboratories and a cardiovascular disease management company. For the past 15 years, he has been tirelessly working to fight against medical companies that are defrauding US taxpayers. His actions have resulted in a court verdict and settlements totaling more than $550 million. (Photo copyright: Leadership Books.)
Riedel became a whistleblower in 2005 when he filed a case under California law that was sealed until 2009. Jerry Brown, California Attorney General at that time, joined the case and unsealed it.
Riedel had acted after his sales representatives informed him that his company, Hunter Laboratories, needed to come up with a way to compete against larger labs’ pricing to survive. Knowing the test-price-discounting practices transpiring within the lab industry in California, Riedel determined he had three choices:
Violate federal and state laws to compete,
Close his business, which would cause him to lay off more than 150 employees and lose most of his life’s savings, or
Try to stop the other companies from participating in fraudulent practices.
“It is very frustrating for honest CEOs of clinical labs to see that they cannot compete well against those lab companies employing fraudulent schemes. Rather than compete on the quality of service of their products as honest companies do, fraudsters compete based on the value of their illegal inducements,” he states on his website. “I felt the pain that many other honest CEO’s and lab owners have had to endure as they try to compete with fraud and watch their life’s work destroyed.”
He chose to try leveling the playing field for all labs and stop taxpayers from being fleeced. After filing that first whistleblower lawsuit in California in 2005, he later filed similar whistleblower lawsuits in other states that had statutes defining how labs were to price lab tests for their Medicaid programs.
Riedel encountered many roadblocks and frustrations during the initial lawsuit, including some genuinely frightening moments. He described one such experience for Dark Daily.
“Quest and Labcorp together went to Blue Shield of California, a major insurance company, and they got our clinical lab kicked out of network. They offered Blue Shield a 10% discount on all their laboratory testing if they would kick Hunter Laboratories out of network,” Riedel explained. “Since [Quest and Labcorp] represented about 70% to 80% of the total outpatient laboratory testing for Blue Shield, it was too good for this insurer to pass up.
“When your lab loses a major insurance carrier like that, you can’t survive. What doctor is going to want to start with a clinical lab that doesn’t have Blue Shield? And existing clients don’t want to subject their patients to having much higher out-of-pocket expenses.
“From that point on, it was like a dagger in our heart,” he added. “We were literally two weeks away from both corporate and personal bankruptcy when we reached our historic settlement with Quest. Had it not been for that settlement, our 150 employees would have lost their jobs, we would have lost our house, and we would have been completely bankrupt. That was very scary, and I had a very hard time dealing with it.”
Uncovering Medical Laboratory Fraud
While performing his research for the whistleblower case, Riedel was astonished by the information and fraud he discovered.
“There was one point where we had to prove that Quest and Labcorp were passing out discounts to some clients that were at or below cost, without giving those same prices to the Medi-Cal program, as required by state law at that time,” Riedel explained. “I personally reviewed over a million documents. It took more than five years, but it was worth it.
“I eventually found three documents that exposed the complete fraud by Quest. These documents showed what Quest had billed Medi-Cal, how much money the company lost client billing and capitation contracts, and how much business they ‘pulled through’ from the government and insurance payers that made up for the staggering losses on deeply discounted client and capitated billing. That was like the silver bullet.”
In the process, Riedel also discovered what it was like to work with the federal Department of Justice.
“The DOJ hates people who file more than one whistleblower lawsuit,” he added. “They don’t like the statute to begin with, and they barely tolerate whistleblowers, so when they find someone who does it time and again, they really don’t like it.”
“Blood Money” (above) contains practical advice and suggestions that are useful for both clinical laboratory executives and pathologists who want to keep their lab operations compliant with federal law, thus not giving whistleblowers any issues to pursue a qui tam lawsuit, as well as lab whistleblowers who observe violations within their clinical labs—or at competing labs—and who want to do something that may rectify the situation. (Photo copyright: Chris Riedel.)
Riedel is considering writing a second book and is trying to decide which qui tam lawsuits will provide the best subject matter.
“I am currently investigating what would be a multi-billion-dollar lawsuit against an insurance company and that is going to be, by far, the biggest of the cases I have ever been involved in. That might make a good book all by itself,” he said.
Riedel finds his work fighting fraud against the government rewarding and plans to continue his efforts in the future.
“Even though it’s risky—and the book details how my life was almost destroyed when the Blood Brothers counter attacked—I enjoy the investigative work and legal challenges. For me, it is very fulfilling, and I am proud to carry the torch for taxpayers,” he says in a statement on his website.
The 368-page book should be of interest to clinical laboratory personnel, healthcare professionals, those considering becoming a whistleblower, and basically anyone involved in medical laboratory testing.
Legal, regulatory, and payer experts outline steps that help medical laboratories better navigate federal and state regulatory guidelines, eliminate coding and billing missteps, and maximize reimbursements
Even as daily COVID-19 test numbers continue to decrease, many clinical laboratories have substantial numbers of COVID-19 test claims that remain unpaid. Despite federal and state law requiring that labs be paid for these tests, commercial health plans are using many strategies to avoid paying labs for COVID-19 test claims.
That means a large portion of the nation’s labs are owed tens of thousands, hundreds of thousands, even millions of dollars for unpaid SARS-CoV-2 test claims they submitted since the onset of the pandemic last year.
What Clinical Labs Can Do to Be Paid for Their COVID-19 Test Claims
These four subject-matter experts provided insider tips and insights on steps clinical laboratories can take to get paid for COVID-19 test claims. This advice can help labs, maximize collected dollars, reduce the chance of post-payment audits, and navigate emerging payer trends.
During the webinar, Caitlin Forsyth, an Associate Attorney at Davis Wright Tremaine LLP in Seattle who specializes in healthcare regulatory compliance, said the new guidance “impressed upon commercial health plans the requirement to cover COVID testing in a lot of different circumstances.” The guidance included information on how providers can be reimbursed for providing COVID-19 care to uninsured people.
However, labs should be aware of what may come after they receive payment.
“We applaud you if you’ve had success thus far in securing reimbursement,” Forsyth continued. “However, clinical laboratories are not necessarily home free if Medicare, Medicaid, or a health plan has paid all or most of the lab claims for COVID-19 tests. This is because the payer may at some point down the line require the laboratory to submit to a post-payment audit. As part of the audit, the government payer or health plan is likely to require a laboratory to provide supporting documentation underscoring the medical necessity of each test performed on each patient at issue.”
What Constitutes ‘Medical Necessity’ for a SARS-CoV-2 Test?
There are many tripwires that can derail COVID-19 test claims. Medical necessity standards related to testing is one example that has been a major area of concern for clinical laboratories.
Kathryn Edgerton, Esq., Counsel at Davis Wright Tremaine LLP in Los Angeles, notes that the guidance providers have received has been “somewhat inconsistent and has created confusion as to what test is covered.” This lack of clarity in Medicare’s guidance has caused many denials of payment.
This Special Report from Dark Daily is the companion to the recent Dark Daily webinar on “Getting Paid for COVID-19 Test Claims: Prepare for Audits, Maximize Reimbursement and Navigate Payer Trends.” Clinical laboratory professionals can download the report by clicking here. (Photo copyright: Dark Daily.)
The webinar panelists provided the following three tips for optimizing billing claims for COVID-19 tests (additional recommendations on decreasing the number of COVID-19 test claim denials, increasing payments, and avoiding post-payment audits are available in the webinar’s on-demand replay and its companion special report):
When seeking reimbursement for COVID-19 testing from non-traditional sources, such as employers, schools, or local governments, ensure valid orders support each test claim. “Even if the employer, school, or local government has agreed to pay for the tests, a medical laboratory still must comply with state laws in regard to persons authorized to order the tests, as well as comply with CLIA requirements for a valid order,” Forsyth said.
Serial testing is on the rise in workplaces to increase the chances of detecting asymptomatic infection. However, Forsyth says, laboratories should “push for direct reimbursement from the workplace” because coverage from Medicare, Medicaid, and health plans is uncertain. “We also expect health plans to start cracking down on tests performed as part of an employment or surveillance program, taking the position that even if there are physician orders supporting each test performed as part of the program, health plans are not required to cover tests,” she added.
COVID-19-only testing providers and independent laboratories should expect health plans to begin narrowing their provider networks. To avoid being pushed out, Steve Stonecypher, Managing Partner at Shipwright Healthcare Group, says laboratories should “think about what you do, how you do it, and how you can be a benefit [to the health plan]. Make the payers think of you not as a nice-to-have in their network, but as a need-to-have in their network.”
COVID-19 Testing Labs Advised to ‘Have All Your Ducks in a Row’
Stonecypher urges clinical laboratories to be vigilant in record keeping, noting that the US Department of Health and Human Services Office of Inspector General (OIG) indicated earlier this year that it will conduct audits that focus on aberrant billing for COVID-19 testing during the pandemic.
“There are flags out there already that the OIG is potentially going to look to do claim audits,” he said. “You can pretty much guarantee that the payers are going to follow. So, have all your ducks in a row. We’re talking about all the individual patient assessments, all that necessary documentation … make sure all of that is in order because payers are going to look at this as an opportunity to come back and recoup money.”
Billing and finance executives, clinical laboratory leadership, compliance officers, and billing and coding administrators are especially encouraged to listen to this webinar about increasing the number of COVID-19 test claims for which the lab is reimbursed. This webinar is available to stream on-demand.
This can be one of the best low-cost, high return investments your lab team can make, particularly if it helps the lab’s coding/billing/collections team interact with health insurance plans to settle SARS-CoV-2 test claims that then bring in tens of thousands or hundreds of thousands of dollars from outstanding claims that have yet to be paid.
Recent attacks illustrate how costly a security breach can be and why clinical laboratories and pathology groups must work to protect their information systems from ransomware attacks
Therefore, it is crucial clinical laboratories and pathology groups have a cybersecurity strategy in place for dealing with ransomware attacks. Running security drills may need to be part of that strategy. Managers and employees should undergo specific training and vendors must be vetted carefully. Without such a strategy, the question is not if an attack will happen, but rather when an attack will succeed.
Ransomware Attackers are Getting Better
“Ransomware is increasing in sophistication; it’s increasing in prevalence. The purveyors of ransomware are generally reinvesting the fees that they collect from the entities they extort to acquire more capabilities,” Beau Woods, Senior Advisor at the federal Cybersecurity and Infrastructure Security Agency (CISA), told The San Diego Tribune.
“They’re getting better, they’re getting more frequent, particularly during the pandemic where we’ve opened up more connectivity to allow more remote work,” he added.
The Scripps Health attack is notable for several reasons, with one being the length of the outage it caused. The attack was first detected on May 1 of this year. It took four weeks before Scripps could restore most of its network and get its Epic EHR back online, Health IT Security reported.
However, the ransomware attack on Universal Health Services (NYSE:UHS) may be the biggest attack so far. It took place on September 27, 2020, and caused a three-week outage. The company told The San Diego Tribune the incident had a $67 million impact on operations.
According to HIPAA Journal, “The phone system was taken out of action, and without access to computers and electronic health records, employees had to resort to pen and paper to record patient information. In the early hours after the attack occurred, the health system diverted ambulances to alternative facilities and some elective procedures were either postponed or diverted to competitors. Patients reported delays receiving test results while UHS recovered from the attack.”
At Utah Pathology Services, an employee e-mail hack resulted in the potential exposure of patient data. The malicious actors attempted to divert funds intended for a physician but failed to do so. However, the information of 112,000 patients was accessible to the hacker during the attempt.
“The compromised data varied by patient but could include names, contact information, insurance details such as ID and group numbers, medical and health information like internal records numbers and clinical and diagnostic information, and some Social Security numbers,” Health IT Security reported.
“We are seeing adversaries that are targeting our pharmaceutical companies, pharmaceutical research, laboratory companies, testing and really even out into the future manufacturing of the vaccine systems,” Bryan S. Ware (above left) Assistant Director for Cybersecurity for the Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) told CyberScoop. CISA Director Christopher Krebs (above right) added, “At the onset of the COVID-19 pandemic, we recognized just how vital the healthcare sector was to the response and we established Project Taken to bring to bear the government’s particular set of skills to protect those organizations.” (Photo copyrights: CyberScoop/Business Insider.)
Value of Patient Data on the Dark Web is Increasing
In the case of the Utah Pathology Services attack, the hackers were specifically after money. However, according to cybersecurity company SecureLink, patient records are “the new prize” for hackers. Healthcare data carries a value of its own on the digital black market. In fact, healthcare data is more valuable than credit card or banking data.
“Healthcare data is valuable on the black market because it often contains all of an individual’s personally identifiable information, as opposed to a single marker that may be found in a financial breach,” SecureLink wrote in a blog post.
A 2018 Trustwave Global Security Report estimated that a healthcare record is worth about $250. Trustwave, however, estimated the value of a banking record at less than $5. That strongly suggests health records are increasing in value.
And even after a healthcare entity has regained control of its IT infrastructure, the hacker still has possession of the stolen patient information. It may take weeks or years for the hacker to sell that information, meaning the breach represents a continuing threat to the healthcare organization and its patients.
Clinical Laboratories Must Prepare for an Attack
Simply understanding the threat is not enough. Clinical laboratory and pathology group managers must have robust plans in place for both protecting patient information and for dealing with a security breach should one occur.
According to a Health IT Security report, “The ransomware attack that struck all 400 UHS care sites and caused three weeks of EHR downtime in September, cost the health system $67 million in recovery costs and lost revenue.”
The report added, “Security researchers have long-recommended the need for providers to shift into a proactive security model, like zero trust. Recent reports show successful cyberattacks on healthcare providers doubled in the last year, with at least 560 providers falling victim to ransomware.”
To deal with the ransomware attacks, we wrote, “CISA, FBI, and HHS advise against paying ransoms. ‘Payment does not guarantee files will be recovered,’ the advisory states. ‘It may also embolden adversaries to target additional organizations, encourage other criminal actors to engage in the distribution of ransomware, and/or fund illicit activities.’ The federal agencies advise organizations to take preventive measures and adopt plans for coping with attacks.
“The advisory suggests:
Training programs for employees, including raising awareness about ransomware and phishing scams. Organizations should ‘ensure that employees know who to contact when they see suspicious activity or when they believe they have been a victim of a cyberattack.’
Regular backups of data and software. These should be ‘maintained offline or in separated networks as many ransomware variants attempt to find and delete any accessible backups.’ Personnel should also test the backups.
Continuity plans in case information systems are not accessible. For example, organizations should maintain ‘hard copies of digital information that would be required for critical patient healthcare.’”
Given the enormous amounts of money hackers can earn from selling protected health information on the Dark Web, it is a near certainty these attacks will continue. Clinical laboratory and anatomic pathology group managers would be well advised to plan for the inevitability that their health system will be targeted.
The precipitous drop in COVID-19 testing leaves clinical lab leaders wondering, “What comes next?” So it’s time to pivot—again.
When the pandemic hit in March 2020, clinical labs faced a sudden halt in routine testing, and many were able to shift quickly to COVID-19 test offerings. Fast forward one year: with the COVID-19 vaccine rollout, SARS-CoV-2 testing in clinical laboratories has rapidly declined. In the United States, COVID-19 testing dropped from two million per day in January 2021 to only about one million by March.
Now labs are having to adapt again, leading forward-looking lab managers and directors to ask:
What will be the new balance between testing for SARS-CoV-2 and routine diagnostics?
Should my clinical laboratory even continue testing for coronavirus?
Where is the best opportunity to generate revenue now?
How do I transition my lab effectively—and efficiently—to best serve patients and the healthcare industry as a whole?
This white paper, Repurposing Your Lab’s Leftover COVID-19 Samples: Building New Revenue and Better Patient Outcomes Through Collaboration with Life Science, answers these questions and more. It explores how the rapid decline in SARS-CoV-2 testing affects molecular laboratories and the life sciences industry as a whole and offers opportunities for drug developers and labs to work together in new and beneficial ways.
Biospecimens present a win-win proposition for both the clinical lab and life sciences industries
As researchers on the life-science side study coronavirus and other diseases, the value of accumulated biosamples is being reevaluated. UCSF Professor Scott VandenBerg, MD, PhD, draws the connection: “Biospecimens are important because they allow researchers to better understand the causes of diseases and evaluate potential therapies.” Labs have always retained biospecimens, but COVID-19 has spotlighted their value.
Drugmakers are expected to prioritize the development of therapeutics for new patient cohorts, such as long-haul COVID-19 patients while verifying the fidelity of biomarkers used to identify and treat comorbidities. Data generated from analysis of leftover COVID-19 samples that labs can provide could dramatically accelerate this process.
This white paper examines how molecular laboratories can generate new revenue while also contributing to the greater good of society. One primary way to achieve both is to harvest more value from samples through new relationships with life science companies and biobanks. In these new business arrangements, labs would also benefit because instead of paying to dispose of their leftover COVID-19 specimens as regulated medical waste, they could biobank them at little to no cost.
Table of Contents—Chapters at a glance
This 24-page white paper, Repurposing Your Lab’s Leftover COVID-19 Samples: Building New Revenue and Better Patient Outcomes Through Collaboration with Life Sciences, includes the following main chapters:
Chapter 1: COVID-19 Testing: What’s Next After the Rapid Ramp Up and Sudden Decline?
While many labs initially lost revenue when routine testing crashed with the pandemic shutdown, the seemingly unending demand for SARS-CoV-2 testing helped labs rally as they pivoted from traditional diagnostics to COVID-19 testing. Some labs reported exceptional year-over-year revenue growth. At least 48% of clinical labs adopted new testing methodologies or automation to meet the demands of COVID volumes, and many startup and pop-up labs were launched, pointing to a significant investment in COVID testing alone. This chapter examines where we are now and what might be ahead now that COVID-19 testing is winding down.
Chapter 2: Looking Beyond COVID-19 Testing to Find Residual Value and Revenue in Collected Specimens
To stay profitable and relevant, every clinical and molecular laboratory’s short-term and long-term strategic planning must consider the evolving nature of the pandemic. This chapter covers what labs should consider as they evaluate how to repurpose their COVID-related assets, including equipment, molecular testing platforms, and COVID-19 specimens themselves.
Chapter 3: Key Points of Molecular Laboratory Diversification into Biobanking
Biobanking can be a positive thing for labs—for example, to supplement revenue, advance research, and lead to other business development in the lab services space. But it also has its challenges. This chapter discusses both the potential benefits of biobanking and the hurdles labs can face, including regulations, logistical difficulties, consent, collecting and managing samples, and building relationships with industry and research partners.
Chapter 4: The Role of LIMS in Biobanking
Questions often surround the value of a sample, such as: How was the sample collected from the patient? How was it stored? Is the label still secure? When will the sample expire and no longer be considered valuable for research? For labs trying to organize their samples and have at-a-glance answers to questions about them, a proper laboratory information management system (LIMS) or laboratory information system (LIS) streamlines the process. This chapter covers what lab managers and directors should consider as they look to strengthen their quality systems to validate and verify their samples and tests.
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Acceptance of digital pathology and whole-slide imaging is now almost universal among academic health center pathology departments and the nation’s largest pathology companies
Across the United States, many private practice anatomic pathology groups now recognize that digital pathology is the path forward for the entire profession. During the past decade, most academic pathology departments and large pathology lab companies have incorporated digital pathology (DP) and whole-slide imaging (WSI) into many of their labs’ daily activities.
However, in community hospital-based anatomic pathology groups, there have been barriers to even the partial adoption of digital pathology. The two biggest barriers are well-known and discussed frequently at conferences and in the literature.
Some Pathologists Reluctant to Give Up Light Microscopes
One recognized barrier to wider adoption of DP is the reluctance of many long-serving pathologists to give up their familiar light microscopes and glass slides so they can make the transition to reading pathology images on a computer screen. These pathologists remain loyal to the tools and workflows that have served them well throughout their careers.
They generally oppose their group’s move to digital pathology when the subject is discussed in partner meetings and strategic retreats. Since many pathology groups require 100% of partners or shareholders to approve major business decisions, even one recalcitrant and stubborn pathologist-partner can block the motion to adopt digital pathology that is supported by most partners.
The second barrier is the fully-loaded cost to acquire, validate, implement, and use a digital pathology system with whole-slide imaging. A full-featured scanner can cost $250,000 or more and acquiring all the software, systems, and tools needed by a group to fully incorporate digital pathology into daily workflow can easily total $500,000 to $1,000,000.
This substantial commitment of a pathology group’s capital can trigger the same intense debates as the original question of whether the pathologists in the group should adopt DP and WSI. And, not surprisingly, in most pathology groups the same dynamics come into play when votes are tallied on the motion for the pathology group to commit the funds necessary to acquire a digital pathology system, the scanners, and associated tools.
Just one or two partner holdouts can block the decision to spend the money, despite that most of the pathologist partners are ready to make the commitment.
More Community Pathology Groups Considering Digital Pathology
Yet, the momentum in favor of adopting DP and WSI continues to build. “Those pathology labs that are early adopters report multiple clinical and financial benefits. These can include generating positive financial outcomes—including the ability to attract new clients, increasing case referrals, and generating new sources of revenue to the group. In turn, the increased revenue can allow the group to increase pathologist compensation,” said Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
Every day, more anatomic pathologists in the United States use a digital pathology system with a workstation (like above) to view whole-slide images and manage their daily caseload. Most academic center pathology departments use digital pathology, as do many of the nation’s largest pathology lab companies. (Photo copyright: WizardHealth.)
“We are in a time when health insurers are hammering away at the reimbursement paid to anatomic pathologists,” Michel continued. “Year after year, payers cut reimbursement for technical component and professional component services. They exclude many pathology groups from payer networks. That is why more community pathology groups are recognizing several important benefits with the use of DP and WSI that can increase a pathology group’s revenue and boost its pathologist compensation.
Community Pathology Groups Can Use Digital Pathology to Add Value
Equally important, there are specific ways that digital pathology and whole-slide imaging increase the value of the clinical services pathologists deliver to their client physicians. These dual benefits of DP are often overlooked—or not discussed—when community pathology groups conduct their annual retreats and debate the key points of when to adopt—and how to fund—a digital pathology system for their group. These benefits range from giving physicians a faster diagnostic answer on their cancer cases to helping the group’s subspecialist pathologists get more case referrals from physicians in other states.
“It’s important for all surgical pathologists to recognize several realities in today’s pathology marketplace,” Michel noted. “First, almost every sector in healthcare is digitizing itself. Reinforcing this trend is the federal government’s mandates for interoperability across EHRs, HISs, and LISs. Any private pathology group practice that lags in its adoption of digital capabilities and digital images will find itself falling farther and farther behind as physicians switch their case referrals to other pathology labs that have converted to digital pathology and whole-slide images.
“Second, pathology groups that adopt DP and WSI put themselves in a position to build market share in their service region, while at the same time increasing case referrals for their in-house subspecialist pathologists from throughout the United States,” Michel continued. “Also, when the histology is done locally, the local pathology group can deliver faster diagnostic answers and provide digital images as appropriate to referring physicians and hospitals in that region without the need to transport glass slides by couriers.
“Third—and this is an often-overlooked benefit of digital pathology—the local pathology group with DP and WSI can recruit today’s graduating pathology residents and fellows who have trained on DP and WSI. These new pathologists typically limit their job search to pathology groups that have gone digital,” Michel noted. “Millennial pathologists trained with digital images in their residency program. They are eager to work with the automated image analysis algorithms now coming to market.”
On Thursday, May 27, at 1:00 PM EDT, Keith Kaplan, MD, Chief Medical Officer of Corista (left), Andrew Evans, MD, Medical Director of Laboratory Medicine at Mackenzie Health (center left), William DeSalvo, President of Collaborative Advantage Consulting and Manager of Histology Operations at Sonora Quest Laboratories in Tempe, Ariz. (center right), and Lisa-Jean Clifford, COO and Chief Strategy Officer at Gestalt Diagnostics (right) will present “Adopting Digital Pathology on a Budget: Getting Started, Knowing What’s Feasible, and Funding Your DP from Overlooked Sources.” Anatomic pathologists, clinical laboratory directors, laboratory managers, clinical pathologists, and laboratory technicians will gain a critical understanding of which components a fully integrated digital pathology system requires, the differences between your lab’s existing LIS and a digital pathology system, budget-minded approaches to buying the components of a digital pathology system and implementing them in a stepwise fashion, and much more! (Photo copyright: Dark Daily.)
Recognizing the significant capital investment needed to acquire and deploy digital pathology and WSI, one goal of the webinar’s panel of experts is to identify ways that pathology groups can go digital on a budget. “We will do our best to identify different ways that pathology groups with limited financial resources can get into digital pathology,” said Keith Kaplan, MD, Chief Medical Officer at Corista in Concord, Mass., who will chair the upcoming webinar. “This may be the first public presentation where there is candid information about different financial strategies that your pathology group can utilize to acquire the scanners, the DP systems, and the associated tools needed for a full conversion to daily digital pathology.”
Don’t overlook how your participation in this webinar can be the foundation for helping your pathology group practice develop a timely, cost-effective path forward to introduce digital pathology and whole-slide imaging. Use of DP and WSI can become an important factor in helping your group offset payer prices cuts, develop new clients and sources of revenue, and increase pathologist compensation.
Click HERE to register today (or copy and paste this URL into your browser: https://www.darkdaily.com/webinar/adopting-digital-pathology-on-a-budget/). Make sure to have your pathology practice administrator and your histology manager join you for this important webinar.
CMS says it is responding to hospitals’ plea for relief from burdensome reporting requirements, but not altering federal price transparency laws
Despite federal price transparency law that went into effect January 1 after a year-long court battle, some hospitals continue to balk at sharing their payer-negotiated rates for healthcare goods and services—including medical laboratory testing—claiming a variety of challenges due to the COVID-19 pandemic, vaccine distribution, and other difficulties, Modern Healthcare reported.
This requirement was originally part of the Hospital Price Transparency Final Rule (84 FR 65524), passed in 2019 during the Trump administration, which required hospitals to “establish, update, and make public a list of their standard charges for the items and services that they provide,” including clinical laboratory test prices. This reporting requirement did not sit well with the AHA.
In a statement, Ashley Thompson, Senior Vice President for Public Policy Analysis and Development for the American Hospital Association, said, “This policy will require hospitals to divert critically needed resources during this historic pandemic to administrative tasks that will not benefit patients.” She added, “We do not believe CMS has the authority to compel the disclosure of these terms and our legal challenge remains ongoing.”
However, if the new proposed rule goes into effect, CMS would no longer expect hospitals to report the rates they have negotiated with each Medicare Advantage plan, RevCycleIntelligence reported.
“Hospitals are often the backbone of rural communities—but the COVID-19 pandemic has hit rural hospitals hard, and too many are struggling to stay afloat,” HHS Secretary Xavier Becerra (above) said in an announcement, RevCycleIntelligence reported. “This rule will give hospitals more relief and additional tools to care for COVID-19 patients and it will also bolster the healthcare workforce in rural and underserved communities.” (Photo copyright: Modern Healthcare.)
CMS Relieving a Burden, Not Eliminating a Requirement
In the fact sheet, CMS wrote that it “is proposing to repeal the requirement that a hospital report on the Medicare cost report the median payer-specific negotiated charge that the hospital has negotiated with all of its MA organization payers, by MS-DRG (Medicare-severity diagnosis related group), for cost reporting periods ending on or after January 1, 2021. CMS estimates this will reduce administrative burden on hospitals by approximately 64,000 hours.”
Experts noted that CMS is attempting to reduce providers’ administrative burdens, while keeping federal price transparency requirements in effect.
“The repeal of this requirement more falls into the bucket of easing hospitals’ burden as opposed to the agency’s stance on hospital price transparency,” Caitlin Sheetz, Director and Head of Analytics at ADVI Health, LLC, told Fierce Healthcare.
Still, the recent CMS action could be a sign that price transparency requirements for hospitals will not intensify, she added. “I would think it is very unlikely that [CMS] would put out a rule that is easing up hospital administrative burden [and] they would then ramp up audits for the hospital price transparency rule.”
AHA Supports CMS’ Latest Proposed Rule on Hospital Reporting
The AHA said the new proposed rule moves in the right direction.
In a statement, Tom Nickels, Executive Vice President of the AHA, said, “We have long said that privately negotiated rates take into account any number of unique circumstances between a private payer and a hospital and their disclosure will not further CMS’ goal of paying market rates that reflect the cost of delivering care.” He added, “We once again urge the agency to focus on transparency efforts that help patients access their specific financial information based on their coverage and care.”
Though federal price transparency rules are evolving, medical laboratories are encouraged to accept that consumer demand is one powerful force driving this trend. Thus, clinical laboratories that currently make it easy for patients to see the prices for common medical laboratory tests in advance of service should gain competitive advantage from this feature over time.
