“The timing of EWC with the release of this policy couldn’t be better,” CEO and founder of Momentum ConsultingValerie Palmieri told Dark Daily in an interview at Monday night’s opening reception. “It’s a great conference to not only catch up with colleagues but really hear and have those difficult discussions about where we are today, where we’re going, and where we need to be.”
Final LDT rule ‘radically’ different than draft
Tim Stenzel, MD, PhD, former director of the FDA’s Office of In Vitro Diagnostics called the finalized rule “radically different” from the proposed rule. In some ways it is less complex: “The bar is lower,” he said, noting that he was voicing his personal views and not those of the federal agency. “I was convinced that there would be lawsuits, but I’m now not sure if that’s advisable.”
Still, laboratory teams will have to parse the more than 500-page document to determine how the final rule relates to their specific circumstances. After that, it won’t be as challenging, Stenzel said.
His advice: First, read the rule. Second, reach out to FDA for help—he’s sure, he said, that the office is geared up to respond to a “ton of questions” about the implications for individual labs and are standing by to answer emails from labs. And, he added in a discussion session, emailing the agency is free.
The final rule will be in force 60 days after it’s published. Stenzel provided a timeline for some of the milestones:
1 Year: Comply with MD(AE) reporting and reporting of corrections and removals.
2 Years: Comply with labeling, registration and listing, and investigational use requirements.
3 Years: QS records and, in some cases, design controls and purchasing controls.
3.5 Years: Comply with high risk (class III) premarket review requirements.
4 Years: Comply with moderate and low-risk premarket review requirements.
Executive Chair and CEO of XiFin, Inc.Lâle White welcomed the audience with a morning keynote entitled “Big Changes in Healthcare” on new regulations and diagnostics players poised to reshape lab testing.
The diagnostics business is in constant flux, she noted, from payer requirements to greater regulatory and compliance burdens on labs. Other factors include the growing senior population and increasingly complex health conditions, rising costs throughout the healthcare ecosystem, falling funding and reimbursement, and staffing shortages.
As for the economic challenges, consumers are increasingly making decisions based on cost, convenience and quality. The population is shifting to Medicare advantage, which is more cost effective. But changes to the star ratings system will mean lower pay for payer organizations. Those companies will, in turn, mitigate their losses by making changes to pre-authorizations and tightening denials, even for clean claims.
Still, White said, more money isn’t the answer.
White urged the audience to use technology, including artificial intelligence and advances in genetic testing, to manage these and other industry changes.
“We need to optimize the tests we order,” she said. “And if we did that, lab diagnostics really has the potential to change the economics of health and improve outcomes.”
The FDA, Stenzel added, is “very interested” in stimulating innovation, building on the laboratory industry’s success in responding swiftly to the COVID pandemic and outbreaks of Monkey Pox, for example.
He shared lessons learned from recent public health emergencies, talked about CDC’s efforts to engage with clinical labs to improve future public health readiness and response and provided an overview of the CDC’s first laboratory-specific center.
“Laboratories are fundamental to public health,” he said. The industry is on the “front lines” when it comes to identifying threats, responding to them, and preparing for future responses.
Robert Michel, Editor-in-Chief of The Dark Report wrapped up the day’s regulatory discussions with a general session on the “regulatory trifecta” that includes the LDT final rule, CLIA regulations, and private payers’ policies for genetic claims.
Theranos founder and former CEO continues down the path she began by defrauding her investors and lying to clinical laboratory leaders about her technology’s capabilities
As a result of the ban, Holmes is “barred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the healthcare sector,” ARS Technica reported.
So, Holmes, who is 39-years old, is basically banned for life. This is in addition to her 11-year prison sentence which was paired with $452,047,200 in restitution.
“The exclusion was announced by Inspector General Christi Grimm of the Department of Health and Human Services’ Office of Inspector General,” ARS Technica noted, adding that HHS-OIG also “excluded former Theranos President Ramesh “Sunny” Balwani from federal health programs for 90 years.” This is on top of the almost 13-year-long prison sentence he is serving for fraud.
“The Health and Human Services Department can exclude anyone convicted of certain felonies from Medicare, Medicaid, and Pentagon health programs,” STAT reported.
“Accurate and dependable diagnostic testing technology is imperative to our public health infrastructure,” said Inspector General Christi Grimm (above) in an HHS-OIG statement. “As technology evolves, so do our efforts to safeguard the health and safety of patients, and HHS-OIG will continue to use its exclusion authority to protect the public from bad actors.” Observant clinical laboratory leaders will recognize this as yet another episode in the Elizabeth Holmes/Theranos fraud saga they’ve been following for years. (Photo copyright: HHS-OIG.)
Why the Ban?
“The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) cited Holmes’ 2022 conviction for fraud and conspiracy to commit wire fraud as the reason for her ban,” The Hill reported.
“False statements related to the reliability of these medical products can endanger the health of patients and sow distrust in our healthcare system,” Grimm stated in the HHS-OIG statement, which noted, “The statutory minimum for an exclusion based on convictions like Holmes’ is five years.
“When certain aggravating factors are present, a longer period of exclusion is justified,” the statement continued. “The length of Holmes’ exclusion is based on the application of several aggravating factors, including the length of time the acts were committed, incarceration, and the amount of restitution ordered to be paid.”
Rise and Fall of Elizabeth Holmes
Readers of Dark Daily’s e-briefs covering the Holmes/Theranos fraud saga will recall details on Holmes’ journey from mega success to her current state of incarceration for defrauding her investors.
In November 2022, she was handed an 11-year prison sentence for not disclosing that Theranos’ innovative blood testing technology, Edison, was producing flawed and false results. Theranos had “raised hundreds of millions of dollars, named prominent former US officials to its board, and explored a partnership with the US military to use its tests on the battlefield,” STAT reported.
To get Holmes physically into prison was a journey unto itself. At one point, evidence showed her as a potential flight risk. “In the same court filings, prosecutors said Holmes and her partner, William Evans, bought one-way tickets to Mexico in December 2021, a fact confirmed by her lawyers,” Dark Daily’s sister publication The Dark Report revealed in “Elizabeth Holmes’ Appeal Questions Competence of CLIA Lab Director.”
Drama around her move into prison continued. “The former CEO’s attorneys are making last-minute legal moves to delay her prison sentence while she appeals her guilty verdict,” Dark Daily reported.
At the same time, Holmes appeared to be on a mission to revamp her public image.
In the Times piece, Holmes talked about her plans to continue to pursue a life in healthcare. “In the story, Holmes contended that she still thinks about contributing to the clinical laboratory field. Holmes told The Times that she still works on healthcare-related inventions and will continue to do so if she reports to prison,” The Dark Report covered in “Elizabeth Holmes Still Wants ‘To Contribute’ in Healthcare.”
In the meantime, her legal fees continued to mount beyond her ability to pay. “Holmes’ prior cadre of lawyers quit after she could not compensate them, The Times reported,” The Dark Report noted. “One pre-sentencing report by the government put her legal fees at more than $30 million,” according to The New York Times.
Apparently, this closes the latest chapter in the never-ending saga of Elizabeth Holmes’ fall from grace and ultimate conviction for defrauding her investors and lying to healthcare executives, pathologists, and clinical laboratory leaders.
The newly approved legislation will “eliminate regulations preventing patients from learning about diagnostic testing and services provided by local clinical laboratories,” according to a press release issued by the Pennsylvania Senate Republicans.
Republican state Senator Rosemary Brown was the bill’s primary sponsor. She was joined as co-sponsors by a bipartisan group of colleagues.
“The regulations prevent patients from learning about clinical laboratories and the services they provide,” Brown said in the press release. “Patients deserve to know about their options when they are selecting a clinical laboratory to perform these important tests and procedures.”
The press release noted that Pennsylvania is the only state that prohibits clinical laboratories from advertising to residents.
“It’s time for Pennsylvania to catch up with the rest of the nation and enable patients to have access to this information,” said co-sponsor of the bill Republican Senator Tracy Pennycuick (above) in a press release. “Our bill would enable advertising while maintaining the important consumer protection provisions that ensure tests and procedures can only be performed based on a doctor’s order.” Once enacted into law, clinical laboratories in Pennsylvania will be able to advertise their services just like labs in other US states. (Photo copyright: Montgomery County Republican Committee.)
Details of Senate Bill 712
The bill applies to clinical laboratory tests ordered by licensed healthcare practitioners and performed by the medical laboratories themselves. Labs are prohibited from making claims “about the reliability and validity of the testing that is inconsistent with the testing proficiency standards” in federal law, the bill states, and labs must disclose that the test “may or may not be covered by health insurance.”
Brown, Pennycuick, and co-sponsor Republican Senator Lynda Schlegel Culver, discussed the need for the new legislation in a March 2023 memo, observing that 70% of healthcare decisions are influenced by clinical laboratory tests.
“As our state and the nation’s healthcare system continues to grow and evolve, consumers are demanding greater transparency and to be more engaged in how healthcare is delivered to them,” they wrote, adding that the state’s current restrictions are “outdated.”
“We believe permitting outreach to Pennsylvania consumers with accurate, scientifically based diagnostic information can be a source of personalized, highly relevant insight to help foster better, more informed dialogue with licensed healthcare providers, which enables Pennsylvania consumers to take action to improve their health,” they wrote.
“Patients should have access to information about the services and procedures available at their local clinical laboratories,” said Senator Culver in the press release. “I want to make sure patients can make informed decisions about where and how to obtain these important health services. Our bill would remove the gag order on this specific set of healthcare services.”
Similar legislation, HB1558, sponsored by Republican Representative Paul Schemel, is currently pending in Pennsylvania’s House of Representatives.
Larger Push for Healthcare Consumerism
Dark Daily and our sister publication The Dark Report have reported extensively about the rise of consumerism in healthcare—including factors such as price transparency—as it applies to medical laboratories.
And in “Millennials Set to Reorder Healthcare and Lab Testing,” The Dark Report advised clinical laboratories on the need to reconfigure key aspects of their services to accommodate the rising numbers of Millennials in the workforce. For example, these consumers are accustomed to using mobile devices to interact with retailers and want the same convenience when obtaining healthcare services from doctors and labs.
Global management consulting firm McKinsey and Company addressed many of these issues in report titled, “Driving Growth through Consumer Centricity in Healthcare.” The authors suggested that healthcare providers need to “redefine the consumer experience” by emulating “consumer-focused companies in other sectors” with “personalized offerings and services, value-based pricing, and an elevated experience—all from distinctive, high-quality brands.”
The report also noted that providers still have a lot of work to do. “Many consumers believe that the health system does not support their care needs, and they perceive that the quality of their healthcare is negatively affected by their personal attributes, including income, insurance coverage, weight, and age, among other factors,” the authors wrote.
Huron, a healthcare consulting company, identified five current trends in healthcare consumerism based on a survey of US consumers, Healthcare Dive reported. They are:
Greater digital functionality, including telehealth, wearable devices to report health data, and mobile apps for scheduling, communication, and payment.
Affordability, shorter wait times, and online ratings as factors driving consumers to choose providers.
Accurate diagnoses and effective treatment plans as drivers of consumer satisfaction.
Increasing demand for technology-enabled conveniences such as virtual care.
More price transparency in response to concerns about affordability.
Pennsylvania’s decision to join the rest of the nation and allow clinical laboratories to advertise their services may be evidence that the growing number of consumers who want direct access to medical care and the ability to choose their provider—be it hospital, physician, or clinical laboratory—are encouraging the pathology and medical laboratory professions to lobby their state lawmakers to make it easier to advertise their services to the public.
McGonnagle’s involvement with medical laboratory medicine spans five decades and 38 years of support for the nation’s anatomic pathologists and clinical laboratory professionals
The presentation was made in front of 950 attendees. During the presentation, several of McGonnagle’s peers described the multiple ways that he regularly supports the profession of clinical laboratory medicine.
In 1986, McGonnagle was engaged by the College of American Pathologists (CAP) to develop the concept of a new, tabloid-sized, color magazine to be called CAP Today. It was January 1987 when monthly publication of CAP Today formally commenced.
McGonnagle was again tapped by CAP to oversee production of another publication that was created in 1996. Since its inception, he has also been publisher of the Archives of Pathology and Laboratory Medicine.
During last week’s Executive War College on Diagnostic, Laboratory, and Pathology Management in New Orleans, Bob McGonnagle (center right) was honored with a Lifetime Achievement Award for his 38 years as Publisher of CAP Today, along with his innumerable contributions to advancing the clinical laboratory and anatomic pathology professions. McGonnagle is joined by Robert Michel, founder of the Executive War College on his right; Al Lui, MD, of Innovative Pathology Medical Group on his far right; and Stan Schofield of Compass Group on his left. (Photo copyright: The Dark Report.)
38 Years as Publisher of CAP Today Magazine
But McGonnagle’s duties as publisher are just the starting point of the contributions McGonnagle has made to the House of Laboratory Medicine in the past 38 years. He is regularly seen at pathology and lab meetings, conferences, and workshops throughout the United States and overseas. As a speaker and moderator, he is much in demand. He is often asked to sit in during strategic retreats and think tanks organized by laboratory associations, lab organizations, and lab vendors.
During the presentation ceremony, three of McGonnagle’s peers offered insights and examples of his unstinting support of pathologists, lab managers, and companies serving medical laboratories. First to speak was Stan Schofield, Managing Principal at Compass Group and past CEO of NorDx Laboratories in Scarborough, Maine.
“Bob McGonnagle is excellent as a moderator for conferences, meetings, and conventions and will always say ‘yes’ when asked to serve,” Schofield observed. “He is quick to recognize and adapt to emerging issues. He processes information from various parts of the lab industry, then generates insights and information all can understand and use to the benefit of their respective labs and pathology groups.”
Next to speak was pathologist Al Lui, MD, President and Medical Director, at Innovative Pathology Medical Group in Torrance, California. Lui has been active on committees and initiatives of CAP for decades. “Recognition of Bob McGonnagle’s past and continuing contributions to the profession of pathology and laboratory medicine is long overdue,” he said.
McGonnagle as Farmer, Fan of Classical Music, and Oenophile
Lui then presented slides that showed the range of McGonnagle’s activities outside of his publishing responsibilities. For example, Bob is remote manager of two inherited family farms in Iowa that produce corn, soybeans, and cattle. His wife competes in equestrian events. They are wine aficionados and close personal friends with one of Napa Valley’s most respected vintners.
One key figure in McGonnagle’s publishing activities is the Editor of CAP TodaySherrie Rice. She has served in this role since 1987 and thus has collaborated with Bob for the 38 years of CAP Today’s publication. “His leadership of the periodicals department at the CAP has been brilliant and working alongside him for more than three decades has been the gift of a lifetime,” Rice noted.
Rice also described an underappreciated aspect of McGonnagle’s efforts as Publisher. “Bob constantly works to connect the IVD manufacturers and lab vendors with labs that need and benefit from these solutions,” she noted. “He is quick to recognize emerging technologies and help explain them with in-depth stories in CAP Today that help pathologists and lab managers better understand when such innovations are ready to be implemented.”
A Career That Spans Five Decades
As McGonnagle was handed his Lifetime Achievement Award, Robert Michel, Founder of the Executive War College and Editor-in-Chief of Dark Daily and its sister publication The Dark Report, made several observations. “Bob McGonnagle has all the hallmarks of a loyal friend. He is always willing to help and never asks for anything in return,” Michel noted. “He is discreet and trustworthy, with keen powers of observation and analysis. Our profession is blessed that his career and contributions have spanned five decades.”
All of Bob McGonnagle’s colleagues, friends, and associates are encouraged to use social media to send him congratulations and notes of appreciation for his 38 years of service as Publisher of CAP Today, and for his many contributions to the clinical laboratory and pathology professions.
Here are social media links where it would be appropriate to post comments about Bob McGonnagle, with best wishes, congratulations, and examples of his selfless support:
The 2023 conference comes as clinical laboratories, diagnostics companies, and anatomic pathology practices wrestle with budgets that are strained by inflation, supply chain woes, and the faltering financial performance of parent hospitals and health systems. Meanwhile, lab hiring managers continue to face a severe staffing shortage of diagnostics employees.
“The current twin trends of hospitals losing money and labs struggling to maintain adequate staffing is without parallel in my 30 years of covering the clinical laboratory, diagnostics, and pathology sectors,” said Robert Michel, Founder of the Executive War College and Editor-in-Chief at Dark Daily. “This is a perfect storm that threatens the ability of labs to sustain high-quality testing services in a financially-sustainable manner. At the 2023 Executive War College, we are going to help participants get through this predicament by giving them innovative insights and best-in-class expertise they can take back and implement in their clinical labs and pathology groups.”
“Staffing and supply chain difficulties are not the only burdens facing clinical laboratories,” said Robert Michel (above), Founder of the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. “Equally stressful forces are altering how providers, payers, and healthcare consumers access medical laboratory testing and pay for those services.” (Photo copyright: The Dark Intelligence Group.)
Earning New Revenue Will Take Center Stage at 2023 Executive War College
The full agenda for the 2023 Executive War College has not yet been released, but attendees can expect to see keynote presentations and sessions devoted to pressing topics in the diagnostics and laboratory industries. Among them is how to best position the clinical lab as a growing revenue source.
“With financial pressures mounting, we intend to present cutting-edge advice from innovative clinical laboratories, diagnostics companies, and pathology practices about how they earn new revenue—whether that be through creating business opportunities in the community, uncovering new test reimbursements, or using technology to improve existing processes,” Michel explained.
Last spring’s gathering of the Executive War College featured 10 keynotes, 55 sessions, and three post-conference workshops. Participants at the upcoming 2023 Executive War College conference can expect a similar bonanza of educational and professional development options, as well as collaborative networking breaks, luncheons, and receptions.
“The chance to meet innovative peers from across the country, share lab-related challenges with them, and compare effective solutions makes the Executive War College a cost-effective investment for any laboratory administrator, executive, or business-minded pathologist,” Michel added.
Diagnostics Services Will Be Better Reflected at 2023 Conference
For the first time, the conference’s moniker directly reflects the diagnostic work associated with clinical laboratories and pathology groups.
“Long-time attendees will notice that we tweaked the Executive War College’s full title to emphasize ‘diagnostics.’ That term is an important addition,” Michel noted.
“In the recent past, ‘clinical laboratory’ and ‘anatomic pathology’ were terms that sufficiently described the profession of laboratory medicine,” he continued. “However, a subtle but significant change has occurred in recent years. The term ‘diagnostics’ has become a common description for medical testing, along with other diagnostic areas such as radiology and imaging.”
Keep an eye on the conference’s website, ExecutiveWarCollege.com, for updates about the upcoming program and to see the session topics and speakers as they are confirmed and announced.
“The Executive War College is the top gathering for lab leaders to learn from the profession’s best innovators and gain insights they will need to keep their laboratories at the cutting edge of clinical excellence in a financially sustainable manner,” Michel concluded.
Register today to ensure places for you and your management team at the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. Click here for early registration discounts.
