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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Great Resignation Hits Retail Pharmacies, Causing Shorter Hours, Closures

As with clinical laboratories, worker shortage is affecting large retail pharmacy chains and independent pharmacies alike

Staffing shortages in clinical laboratories and anatomic pathology groups caused by the Great Resignation is having a similar impact on retail pharmacy chains. Consequently, pharmacy chains are reducing store hours and even closing sites, according to USA Today.

As Dark Daily covered in “Clinical Laboratories Suffer During the ‘Great Resignation,” the US Bureau of Labor Statistics reported that from August 2021 through December 2021, the healthcare and social assistance workforce saw nearly 2.8 million workers quit—an average of 551,000 people during each of those months. By comparison, in December 2020, 419,000 healthcare workers left their jobs.

Pharmacies now report similar shortages in qualified workers, partly due to the sharp decrease in revenue from COVID-19 vaccinations, but also due to worker burnout. Both developments have counterparts in clinical laboratories as well.

B. Douglas Hoey, PharmD

“I’m concerned that without the help from the COVID-19 vaccinations that everyone needed, these pharmacies that were able to tough it out for another year or two might not be able to continue,” B. Douglas Hoey, PharmD, CEO of the National Community Pharmacists Association (NCPA), told USA Today. Clinical laboratories that processed large numbers of SARS-CoV-2 diagnostics have experienced the same sudden drop in revenue causing similar difficulties maintaining staffing levels. (Photo copyright: Cardinal Health.)

Staffing Shortages Leading to Safety Concerns

According to the Washington Post’s coverage of a study conducted in 2021 of 6,400 pharmacists in various retail and hospital environments, a majority did not feel they could conduct their jobs efficiently or safely.

  • “75% of the pharmacists in [the] survey disagreed with the statement ‘Sufficient time is allocated for me to safely perform patient care/clinical duties.’”
  • “71% said there were not enough pharmacists working to ‘meet patient care/clinical duties.’”
  • “65% said ‘payment for pharmacy services’ did not support their ‘ability to meet clinical and non-clinical duties.’”

“Workplace conditions have pushed many pharmacists and pharmacy teams to the brink of despair,” said the board of trustees of the American Pharmacists Association (APhA) in a press release, the Washington Post reported. “Pharmacy burnout is a significant patient safety issue. It is impacting patients today with delayed prescription fulfillment, unacceptable waits for vaccines and testing, and potential errors due to high volume, long hours, and pressure to meet performance metrics.”

This is a sentiment that has been repeated across every facet of healthcare—including in clinical laboratories—where staff shortages are being felt.

Shortage of Pharmacists or Lack of Morale?

In “Drugstores Make Slow Headway on Staffing Problems,” the Associated Press outlined from where it believes the staffing problems originate. “There isn’t a shortage of pharmacists. There’s just a shortage of pharmacists who want to work in those high-stress environments that aren’t adequately resourced,” Richard Dang, PharmD, Assistant Professor of Clinical Pharmacy at the University of Southern California (USC), told the Associated Press.

This statement is reminiscent of the views expressed by Susanna Bator, a former clinical laboratory technician, in her personal essay published in The Daily Nurse titled, “The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic.” She previously worked at the Cleveland Clinic and with MetroHealth System in Cleveland, Ohio.

Dark Daily covered Bator’s journey as a clinical laboratory technician working in the trenches during the COVID-19 pandemic in “Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic.”

“The pressure never let up. No matter how mind-numbing and repetitive the work could get, we had to work with constant vigilance, as there was absolutely no room for error,” Bator wrote.

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

Healthcare workers feeling burnt out and under-appreciated during the pandemic led to mass resignations that produced staffing shortages throughout the industry. It appears this trend has caught up to pharmacies as well.

Workforce Wasn’t Ready

Local and chain pharmacies played an important role in the COVID-19 pandemic. Pharmacists distributed COVID-19 tests and treatment to their communities. But for many it was a struggle to keep up.

Stefanie Ferreri, PharmD, Distinguished Professor in Pharmacy Practice and Chair of the Division of Practice Advancement and Clinical Education at University of North Carolina’s Eshelman School of Pharmacy, told the Associated Press that she felt the expanding role of pharmacies in public health was “awesome” but stated that “the workforce wasn’t quite ready” for what took place during the pandemic.

Much like Bator recounted in her essay, pharmacy workers suddenly had new responsibilities, longer working hours, and little room for error.

“There are multiple stories about pharmacists just getting overwhelmed. The stress level and burnout is high,” Dima M. Qato, PharmD, PhD, told USA Today. Qato is Hygeia Centennial Chair and Associate Professor (with tenure) in the Titus Family Department of Clinical Pharmacy at the University of Southern California. “So, pharmacists leave, and stores have to shorten” their hours, she added.

Scheduling and Patience Can Help

What can be done to soften some of the issues staff shortages are causing? Ferreri suggests that pharmacies set appointment times for regular customers so that a pharmacist’s workload can be more predictable. An appointment system can ease stress for both the pharmacist and patient. Ferreri advises customers to be patient when it comes to their prescriptions. She suggests patients give pharmacies more than a day’s notice for refills.

“I think on both sides of the counter, we need to all have grace and realize this is a very challenging and stressful time for everyone,” said Brigid Groves, PharmD, Vice President, Pharmacy Practice at the American Pharmacists Association.

With burnout, staff shortages, and stress affecting nearly every aspect of the healthcare industry, having patience with each other will go a long way to helping clinical laboratories, pharmacies, and patients navigate the road ahead.

Ashley Croce

Related Information:

Pharmacies Are Cutting Hours and Closing Stores. What It Means for Customers.

Pharmacists Are Burning Out. Patients Are Feeling the Effects.

Drugstores Make Slow Headway on Staffing Problems

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

US Hospitals Continue to Be Squeezed by Shortage of Nurses, Rising Salaries

Clinical Laboratories Suffer During the ‘Great Resignation’

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

Attention All Surgical Pathologists: Algorithms for Automated Primary Diagnosis of Digital Pathology Images Likely to Gain Regulatory Clearance in Near Future

Hello primary diagnosis of digital pathology images via artificial intelligence! Goodbye light microscopes!

Digital pathology is poised to take a great leap forward. Within as few as 12 months, image analysis algorithms may gain regulatory clearance in the United States for use in primary diagnosis of whole-slide images (WSIs) for certain types of cancer. Such a development will be a true revolution in surgical pathology and would signal the beginning of the end of the light microscope era.

A harbinger of this new age of digital pathology and automated image analysis is a press release issued last week by Ibex Medical Analytics of Tel Aviv, Israel. The company announced that its Galen artificial intelligence (AI)-powered platform for use in the primary diagnosis of specific cancers will undergo an accelerated review by the Food and Drug Administration (FDA).

FDA’s ‘Breakthrough Device Designation’ for Pathology AI Platform

Ibex stated that “The FDA’s Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by, the FDA, and provides formal acknowledgement of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.”

“All surgical pathologists should recognize that, once the FDA begins to review and clear algorithms capable of using digital pathology images to make an accurate primary diagnosis of cancer, their daily work routines will be forever changed,” stated Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report. “Essentially, as FDA clearance is for use in clinical care, pathology image analysis algorithms powered by AI will put anatomic pathology on the road to total automation.

“Clinical laboratories have seen the same dynamic, with CBCs (complete blood counts) being a prime example. Through the 1970s, clinical laboratories employed substantial numbers of hematechnologists [hematechs],” he continued. “Hematechs used a light microscope to look at a smear of whole blood that was on a glass slide with a grid. The hematechs would manually count and record the number of red and white blood cells.

“That changed when in vitro diagnostics (IVD) manufacturers used the Coulter Principle and the Coulter Counter to automate counting the red and white blood cells in a sample, along with automatically calculating the differentials,” Michel explained. “Today, only clinical lab old-timers remember hematechs. Yet, the automation of CBCs eventually created more employment for medical technologists (MTs). That’s because the automated instruments needed to be operated by someone trained to understand the science and medicine involved in performing the assay.”

Primary Diagnosis of Cancer with an AI-Powered Algorithm

Surgical pathology is poised to go down a similar path. Use of a light microscope to conduct a manual review of glass slides will be supplanted by use of digital pathology images and the coming next generation of image analysis algorithms. Whether these algorithms are called machine learning, computational pathology, or artificial intelligence, the outcome is the same—eventually these algorithms will make an accurate primary diagnosis from a digital image, with comparable quality to a trained anatomic pathologist.

How much of a threat is automated analysis of digital pathology images? Computer scientist/engineer Ajit Singh, PhD, a partner at Artiman Ventures and an authority on digital pathology, believes that artificial intelligence is at the stage where it can be used for primary diagnosis for two types of common cancer: One is prostate cancer, and the other is dermatology.

Ajit Singh, PhD speaking at the Executive War College

On June 17, Ajit Singh, PhD (above), Partner at Artiman Ventures, will lead a special webinar and roundtable discussion for all surgical pathologists and their practice administrators on the coming arrival of artificial intelligence-powered algorithms to aid in the primary diagnosis of certain cancers. Regulatory approval for such solutions may happen by the end of this year. Such a development would accelerate the transition from light microscopes to a fully digital pathology workflow. Singh is shown above addressing the 2018 Executive War College. (Photo copyright: The Dark Report.)

“This is particularly true of prostate cancer, which has far fewer variables compared to breast cancer,” stated Singh in an interview published by The Dark Report in April. (See TDR, “Is Artificial Intelligence Ready for First Use in Anatomic Pathology?” April 12, 2021.)

“It is now possible to do a secondary read, and even a first read, in prostate cancer with an AI system alone. In cases where there may be uncertainty, a pathologist can review the images. Now, this is specifically for prostate cancer, and I think this is a tremendous positive development for diagnostic pathways,” he added.

Use of Digital Pathology with AI-Algorithms Changes Diagnostics

Pathologists who are wedded to their light microscopes will want to pay attention to the impending arrival of a fully digital pathology system, where glass slides are converted to whole-slide images and then digitized. From that point, the surgical pathologist becomes the coach and quarterback of an individual patient’s case. The pathologist guides the AI-powered image analysis algorithms. Based on the results, the pathologist then orders supplementary tests appropriate to developing a robust diagnosis and guiding therapeutic decisions for that patient’s cancer.

In his interview with The Dark Report, Singh explained that the first effective AI-powered algorithms in digital pathology will be developed for prostate cancer and skin cancer. Both types of cancer are much less complex than, say, breast cancer. Moreover, the AI developers have decades of prostate cancer and melanoma cases where the biopsies, diagnoses, and downstream patient outcomes create a rich data base from which the algorithms can be trained and tuned.

To help surgical pathologists, pathologist-business leaders, and pathology group practice administrators understand the rapid developments in AI-powered digital pathology analysis, Dark Daily is conducting “Clinical-Grade Artificial Intelligence (AI) for Your Pathology Lab: What’s Ready Now, What’s Coming Soon, and How Pathologists Can Profit from Its Use,” on Thursday, June 17, 2021, from 1:00 PM to 2:30 PM EDT.

This webinar is organized as a roundtable discussion so participants can interact with the expert panelists. The Chair and Moderator is Ajit Singh, PhD, Adjunct Professor at the Stanford School of Medicine and Partner at Artiman Ventures.

Panelists for June 17 webinar, Clinical-Grade Artificial Intelligence (AI) for Your Pathology Lab: What’s Ready Now, What’s Coming Soon, and How Pathologists Can Profit from Its Use

The panelists (above) represent academic pathology, community hospital pathology, and the commercial sector. They are:

Because the arrival of automated analysis of digital pathology images will transform the daily routine of every surgical pathologist, it would be beneficial for all pathology groups to have one or more of their pathologists register and participate in this critical webinar.

The roundtable discussion will help them understand how quickly AI-powered image analysis is expected be cleared for use by the FDA in such diseases as prostate cancer and melanomas. Both types of cancers generate high volumes of case referrals to the nation’s pathologists, so potential for disruption to long-standing client relationships, and the possible loss of revenue for pathology groups that delay their adoption of digital pathology, can be significant.

On the flip side, community pathology groups that jump on the digital pathology bandwagon early and with the right preparation will be positioned to build stronger client relationships, increase subspecialty case referrals, and generate additional streams of revenue that boost partner compensation within their group.

Act now to guarantee your place at this important webinar. Click HERE to register, or copy and paste the URL https://www.darkdaily.com/webinar/clinical-grade-artificial-intelligence-for-your-pathology-lab/ into your browser.

Also, because so many pathologists are working remotely, Dark Daily has arranged special group rates for pathology practices that would like their surgical pathologists to participate in this important webinar and roundtable discussion on AI-powered primary diagnosis of pathology images. Inquire at info@darkreport.com or call 512-264-7103.

—Michael McBride

Related Information:

Ibex Granted FDA Breakthrough Device Designation: Ibex’s Galen AI-powered platform is recognized by the FDA as breakthrough technology with the potential to more effectively diagnose cancer

Is Artificial Intelligence Ready for First Use in Anatomic Pathology?

Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid

Painless technology could one day replace some phlebotomy blood draws as the go-to specimen-collection method for clinical laboratory testing and health monitoring

Clinical laboratories have long sought a non-invasive way to do useful medical laboratory testing without the need for either a venipuncture or a needle stick. Now engineers at the McKelvey School of Engineering at Washington University in St. Louis in Missouri have developed a disposable microneedle patch that one day could be a painless alternative to some blood draws for diagnostics tests and health monitoring.

The technology uses an easy-to-administer low-cost patch that can be applied to the skin like an adhesive bandage. The patch is virtually painless because the microneedles are too small to reach nerve receptors. Another unique aspect to this innovative approach to collecting a specimen for diagnostic testing is that the Washington University in St. Louis (WashU) research team designed the microneedle patch to include plasmonic-fluor. These are ultrabright gold nanolabels that light up target protein biomarkers and can make the biomarkers up to 1,400 times brighter at low concentrations, compared to traditional fluorescent labels.

The patch, states a WashU news release, “… can be applied to the skin, capture a biomarker of interest and, thanks to its unprecedented sensitivity, allow clinicians to detect its presence.”

The technology is low cost, easy for clinicians or patients themselves to use, and could eliminate the need for a trip to patient service center where a phlebotomist would draw blood for clinical laboratory testing, the news release states.

Srikanth Singamaneni, PhD
“We have created a platform technology that anyone can use. And they can use it to find their own biomarker of interest,” study leader Srikanth Singamaneni, PhD (above), Lilyan and E. Lisle Hughes Professor in the Department of Mechanical Engineering and Materials Sciences at Washington University in St. Louis, said in the WashU news release. Singamaneni and his colleagues are developing a new specimen collection method that might someday be widely used by clinical laboratories. (Photo copyright: Washington University in St. Louis.)

The WashU researchers published their study, titled, “Microneedle Patch for the Ultrasensitive Quantification of Protein Biomarkers in Interstitial Fluid,” in the journal Nature Biomedical Engineering.

Minimally Invasive Specimen Collection

“We used the microneedle patch in mice for minimally invasive evaluation of the efficiency of a cocaine vaccine, for longitudinal monitoring of the levels of inflammatory biomarkers, and for efficient sampling of the calvarial periosteum [a skull membrane]—a challenging site for biomarker detection—and the quantification of its levels of the matricellular protein periostin, which cannot be accurately inferred from blood or other systemic biofluids,” the researchers wrote. “Microneedle patches for the minimally invasive collection and analysis of biomarkers in interstitial fluid might facilitate point-of-care diagnostics and longitudinal monitoring.”

Mark Prausnitz, PhD, Regents’ Professor, J. Erskine Love Jr. Chair in Chemical and Biomolecular Engineering, and Director of the Center for Drug Design, Development, and Delivery at Georgia Tech, told WIRED, “Blood is a tiny fraction of the fluid in our body. Other fluids should have something useful—it’s just hard to get those fluids.”

“Previously, concentrations of a biomarker had to be on the order of a few micrograms per milliliter of fluid,” said Zheyu (Ryan) Wang, a PhD candidate in Srikanth Singamaneni’s lab at McKelvey School of Engineering and a lead author of the paper, in the WashU news release. By using plasmonic-fluor, researchers were able to detect biomarkers on the order of picograms per milliliter—one millionth of the concentration.

“That’s orders of magnitude more sensitive,” Wang said.

plasmonic-fluor yellow spikes
Unlike blood, dermal interstitial fluid often does not contain high enough concentrations of biomarkers to be easily detectable. To overcome this hurdle, the Washington University in St. Louis research team developed a microneedle patch with plasmonic-fluor—ultrabright gold nanolabels (above)—which lit up target protein biomarkers, making them roughly 1,400 times brighter at low concentrations than when using traditional fluorescent labels commonly used in many medical laboratory tests. (Photo copyright: Washington University in St. Louis.)

Can Microneedles Be Used as a Diagnostic Tool?

As reported in WIRED, the polystyrene patch developed by Srikanth Singamaneni’s lab at McKelvey School of Engineering removes interstitial fluid from the skin and turns the needles into “biomarker traps” by coating them with antibodies known to bind to specific proteins, such as Interleukin 6 (IL-6). Once the microneedles are mixed with plasmonic-fluor, the patch will glow if the IL-6 biomarkers are present.

The development of such a highly sensitive biomarker-detection method means skin becomes a potential pathway for using microneedles to diagnose conditions, such as myocardial infarction or to measure COVID-19 antibodies in vaccinated persons.

“Now we can actually use this tool to understand what’s going on with interstitial fluid, and how we’re going to be able to use it to answer healthcare-related or medical problems,” Maral Mousavi, PhD, Assistant Professor of Biomedical Engineering, Viterbi School of Engineering at the University of Southern California, told WIRED. “I think it has the potential to be that kind of a game changer.”

Because the WashU study is a proof-of-concept in mice, it may be many years before this technology finds its way to clinical application. Many skin biomarkers will need to be verified for direct links to disease before microneedle patches will be of practical use to clinicians for diagnostics. However, microneedle patch technology has already proven viable for the collection of blood.

In 2017, Massachusetts-based Seventh Sense Biosystems (7SBio) received 510(k) clearance for a new microneedle blood collection device. Called TAP, the device is placed on the upper arm and blood collection starts with a press of a button. The process takes two to three minutes.

Initially, the FDA clearance permitted only healthcare workers to use the device “to collect capillary blood for hemoglobin A1c (HbA1c) testing, which is routinely used to monitor blood sugar levels in diabetic or pre-diabetic patients,” a Flagship Pioneering news release noted.

Then, in 2019, the FDA extended its authorization “to include blood collection by laypersons. Regulators are also allowing the device to be used ‘at-home’ for wellness testing,” a 7SBio news release stated. This opened the door for a microneedle device to be used for home care blood collection.

“No one likes getting blood drawn, but blood is the single-most important source of medical information in healthcare today, with about 90% of all diagnostic information coming from blood and its components,” Howard Weisman, former CEO of 7SBio and current CEO of PaxMedica, a clinical-stage biopharmaceutical company, said in the Flagship Pioneering news release. “TAP has the potential to transform blood collection from an inconvenient, stressful, and painful experience to one people can do themselves anywhere, making health monitoring much easier for both healthcare professionals and patients.”

As microneedle technology continues to evolve, clinical laboratories should expect patches to be used in a growing number of drug delivery systems and diagnostic tests. But further research will be needed to determine whether interstitial fluid can provide an alternate pathway for diagnosing disease.

—Andrea Downing Peck

Related Information:

Microneedle Patch for the Ultrasensitive Quantification of Protein Biomarkers in Interstitial Fluid

No More Needles

Forget Blood—Your Skin Might Know If You’re Sick

First-Ever Device for Fast and Virtually Painless Blood Draw Receives FDA Clearance

Microneedle Patch with Plasmonic Fluor, Ultrabright Gold Nanolables (IMAGE)

Microneedle Patch Could Replace Standard Tuberculosis Skin Test

Seventh Sense Biosystems Unlocks Market for Consumer Blood Collection Through Layperson Clearance

Walmart and Home Depot Employ Copay Accumulators to Keep Employee Healthcare Costs Down and Encourage Utilization of Generic Prescription Drugs

While clinical laboratories may not be directly affected by copay accumulators, anything that affects patients’ ability to pay for healthcare will likely impact lab revenues as well

Here’s a new term and strategy that some big employers are deploying in an attempt to control the choice of health benefits provided to their employees. The term is “copay accumulator” and it is intended to offset efforts by pharmaceutical companies to minimize what consumers must pay out-of-pocket for expensive prescription drugs.

Clinical laboratory managers and pathologists will have a front row seat to watch this next round in the struggle between industry giants for control over how patients pay for drugs and treatment regimes.

Pharmaceutical companies on one side and health insurers and employers on the other side have played brinksmanship over medication copays for years. Now at the center of this struggle are copay accumulators, a relatively new feature of plans from insurers and pharmacy benefit managers (PBMs) on behalf of the large employers they serve.

More than 41-million Americans use copay accumulators, and about nine million use similar though limited copay maximizer programs, Zitter Health Insights, a New Jersey-based pharma and managed care consultancy firm, told Reuters.

Now, big employers are getting in on the game. Walmart (NYSE:WMT) and Home Depot (NYSE:HD) are among a growing number of companies using copay accumulators and copay maximizers to keep their healthcare costs down and encourage employees to seek lower-cost alternatives to expensive brand prescriptions (generic drugs).

About 25% of employers currently use such programs, and 50% of employers are anticipated to be doing so in just two more years, the National Business Group on Health told Reuters.

What Are Copay Accumulators and How Do They Work?

In response to popular drug company discount cards, insurance companies developed the “copay accumulator.” Here’s how it works.

Typically, patients’ insurance plan deductibles can be thousands of dollars. Thus, even after plan discounts, patients often pay hundreds, even thousands of dollars each month for prescribed medications. Insurance companies see a beneficial side to this, stating the cost encourages patients to be aware of their medications and motivates them to try lower-cost non-branded alternatives (generic drugs), all of which saves insurance plans money.

However, many patients with high-deductibles balk at paying the high cost. They opt to not fill prescriptions, which costs pharmaceutical companies money.

To encourage patients to fill prescriptions, drug companies provide discount cards to help defray the cost of the drugs. The difference between the discounted payment and the full price of the drug is paid by the pharmaceutical company. But these discount cards interfere with insurance companies’ ability to effectively track their enrollees’ drug usage, which impacts the payers’ bottom lines.

Thus, health insurance companies developed the copay accumulator, which Dark Daily explained in, “Copay Accumulators Is a New Tactic in Struggle Between Payers and Pharma at Patients’ Expense,” October 24, 2018.

When a patient uses a drug discount card at the point-of-sale, the sale is noted by the patient’s health insurer and the insurer’s copay accumulator program kicks in. It caps the total accumulated discount an enrollee can take for that medication and prevents any patient payments to apply toward the plan’s deductible. Once the drug company’s discount card threshold is reached, the patient bears the full cost of the drug, a ZS Associates Active Ingredient blog post explained.

Geoffrey Joyce, PhD
“There are no good guys here. This is about control of the market,” said Geoffrey Joyce, PhD (above), Chair, Department of Pharmaceuticals and Health Economics, University of Southern California, told the Los Angeles Times. “The loser is the patient.” (Photo copyright: Association for Public Policy Analysis and Management.)

Critics of copay accumulators point out that patients could end up paying full price for extremely expensive prescriptions they previously accessed with discount cards, while simultaneously making no progress toward fulfilling their insurance deductibles. Or, they will simply stop taking their medications altogether.

“A medication which previously cost $7 may suddenly cost hundreds or even thousands of dollars because the maximum amount of copay assistance from the [drug] manufacturer was reached,” noted Ken Majkowski, Pharm.D, Chief Pharmacy Officer at FamilyWize (a company that offers its own prescription savings programs), in a blog post. “Since the health plan will no longer allow the copay amounts to contribute to the patient’s deductible, the cost of the medication remains very high.”

Major Employers Implement Their Own Copay Accumulator Programs

Enter the next goliath into the fray—the large employer. Executives at Walmart and Home Depot say discount drug coupons drive up healthcare costs and give their employees and their family members no incentive to explore lower cost alternatives, Reuters reported.

Walmart’s pharmacy benefits are managed by Express Scripts, a prescription benefit plan provider that fills millions of prescriptions annually, according to the company’s website.  Meanwhile, Home Depot’s pharmacy benefits are operated by CVSHealth, which focuses on therapies for cystic fibrosis, hepatitis C, cancer, HIV, psoriasis, pulmonary arterial hypertension, and hyperlipidemia, Reuters noted.

Insurance Associations Weigh-In

Health insurance company representatives say the need for copay accumulators begins with the high price of pharmaceuticals. Insurers are not the only ones concerned about these costs. The American Hospital Association (AHA), the Federation of American Hospitals (FAH), and the American Society of Health-System Pharmacists (ASHP) recently released a report showing total drug spending per hospital admission increased by 18% between 2015 and 2017, and some drug categories rose more than 80%.

University of Chicago National Opinion Research Center (NORC) compiled the data for the report.

“The bigger question is why do we need copay coupons at all? It’s very important to recognize the problem starts with the [drug] price. This is the real underlying problem,” Cathryn Donaldson, Director of Communications, America’s Health Insurance Plans (AHIP), told the Los Angeles Times.

In their blog post, ZS Associates advised drug companies to “push-back” on the copay accumulators. The Evanston, Ill.-based consultancy firm recommends pharma executives change the way they run the discount cards—such as paying rebates directly to patients instead of working through pharmacies.

Medical laboratory leaders need to be aware of programs, such as copay accumulators, and the associated issues that affect patients’ ability to pay for their healthcare. Because large numbers of patients struggle to pay these high deductibles, it means clinical laboratories will be competing more frequently with hospitals, physicians, imaging providers, and others to get patients to pay their lab test bills.

—Donna Marie Pocius

Related Information:

Walmart, Home Depot Adopt Health Insurer Tactic in Drug Copay Battle

Five Steps to Address the Pain Points of Copay Accumulator Programs

They’re Called Copay Accumulators, and They’re a Way Insurance Companies Make You Pay More for Meds

Understanding Copay Accumulators

Walmart and Home Depot are Adopting this Insurer Tactic

Recent Trends in Hospital Drug Spending and Manufacturer Shortages

Copay Accumulators is a New Tactic in Struggle Between Payers and Pharma at Patient’s Expense

Even as Digital Pathology Is Poised to Be Disruptive in Primary Diagnosis, Most Anatomic Pathology Groups Are Unprepared for How Their Incomes Will Change

Pathologists and practice administrators should prepare a strategy and a timetable for their group’s acquisition and deployment of a digital pathology system and whole slide imaging

Anatomic pathology is a medical specialty at the brink of a major technological disruption. FDA clearance of the first digital pathology system and whole slide imaging (WSI) for primary diagnosis means that every surgical pathologist will soon need to decide when to adopt this technology to avoid declines in group revenue and pathologist compensation.

Not in decades have pathologists faced a comparable dual threat. One threat is the use of digital pathology and WSI for primary diagnosis in ways that deliver faster answers to referring physicians, while creating new business models for anatomic pathology groups. At greatest risk from this technology, however, may be sub-specialist pathologists who depend on specialty referrals and second-opinion consults.

Second Threat Is How Digital Pathology Can Erode Pathology Group’s Revenue

The second threat is how failure to adopt digital pathology and WSI at the right time in the market cycle will put a pathology group’s revenue at risk, while causing pathologist compensation to erode. Pathology groups that are quick to adopt digital pathology and whole slide imaging are expected to gain clinical advantage and additional case referrals, while pathology groups that defer adoption will probably lose market share—and the revenue associated with those lost case referrals.

How Fast Will Pathology Groups Act to Implement Digital Pathology?

It was last April when the FDA cleared the first digital pathology system and whole slide imaging for use in the primary diagnosis of biopsied tissue and resection cases. With clearance to market of the Philips IntelliSite Pathology Solution (PIPS), it is expected that other companies will submit their digital pathology systems for FDA review as well. As that happens, the market for digital pathology systems will expand and become more competitive.

“How fast pathologists in the United States adopt digital pathology for primary diagnosis is the big question,” observed Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “We’ve interviewed pathologists at several community pathology group practices who currently use digital pathology and whole slide images for things like tumor boards, second opinion consults within and without their practice, and teaching purposes. They have strong opinions about how quickly they want their group to begin using a digital pathology system for primary diagnosis.

“For example, Advanced Pathology Associates (APA) in Rockville, Md., is a group with 15 pathologists who cover seven hospitals,” stated Michel. “APA was the community pathology group site for the study data Philips needed to submit with its FDA pre-market application. They had the system for the nine-month trial and used it to evaluate 500 cases and thousands of glass slides and WSIs. APA returned the system at the conclusion of the study, but pathologists at APA are already in the process of acquiring their own digital pathology system to use for primary diagnosis.”

Anatomic Pathology Group Went Hands-on with Digital Pathology System

In a story The Dark Report published about Advanced Pathology Associates, pathologist Nicolas Cacciabeve, MD, APA’s Managing Partner, commented, “Because we had the opportunity to be hands-on with this digital pathology system, we saw how it changes daily workflow, improves the ergonomics of reading cases, and contributes to increased productivity.”

Cacciabeve identified the immediate benefits APA will accrue after it acquires its own digital pathology system and begins to use it for primary diagnosis. “[Having a digital pathology system] … also opens new opportunities for our pathologists to add more value—whether it is handling more complex cases through real-time consultation, or through better data management and image retrieval, or freeing up pathologists to get out of the lab to collaborate with clinicians.”

Pathologist Clive Taylor, MD, Considers DP’s Clearance to Be ‘Huge’

The FDA’s clearance of the first digital pathology system was called “huge” by noted pathologist Clive Taylor, MD, PhD, a professor of pathology at the Keck School of Medicine at the University of Southern California (where he served as Chair of Pathology from 1984 to 2009) in an interview with The Dark Report published on July 17.

“The FDA’s clearance of this system for primary diagnosis is huge,” stated Taylor. “… I say that because digital slide scanners in many pathology departments around the country are used secondarily. For example, a pathologist will look at a glass biopsy slide today and think, ‘I should scan this to get a score, or an accurate count, or to send it to a colleague in Washington or London or some place.’ In that sense, pathology labs are using whole slide imaging for secondary purposes.

“The FDA clearance of whole slide imaging for primary diagnostics will foster changes in anatomic pathology departments that will improve the accuracy and speed of diagnosis and drastically reduce the time it takes to get second opinions and to reach a primary diagnosis,” Taylor predicted.

Pathologists, Practice Administrators Need a Strategy for Digital Pathology

Because of the potential for digital pathology systems and whole slide imaging to be disruptive to both the clinical practice of pathology and the revenue and income earned by pathologists, it is recommended that pathology practice administrators and pathologist business leaders of their respective groups understand this new technology and how early-adopter pathology labs are using it to add value to their diagnostic services while generating new streams of revenue.

The four expert speakers for this critical Dark Daily webinar are (clockwise from upper left): Keith Kaplan, MD, Chief Medical Officer, Corista, Concord, Mass.; Liron Pantanowitz, MD, Professor of Pathology and Biomedical Informatics at the University of Pittsburgh Medical Center, Pittsburgh; Isaac R. Grindeland, MD, Gastrointestinal Pathology, Incyte Diagnostics, Spokane Valley, Wash.; and Dan Angress, for ClearPath Derm of Dayton, Ohio, and President of Angress Consulting, LLC, Los Angeles, Calif. (Photo copyright: Dark Daily.)

To give practice administrators and interested pathologists this comprehensive knowledge of digital pathology and whole slide imaging, Dark Daily is presenting a special webinar, titled, “Primary Diagnosis with Digital Pathology Systems and Whole Slide Images: What Every Pathologist Needs to Know, Why It Will Be Disruptive, and How Innovative Pathology Groups Are Already Making Money with DP.”

This critical webinar takes place on Thursday, August 17, 2017 at 1:00 PM EDT.

Essential Knowledge about Digital Pathology Systems, Whole Slide Imaging

The webinar is organized to help all pathology groups, academic pathology departments, and pathology laboratories understand:

  • The current capabilities of the technology for digital pathology and WSI;
  • How these technologies are evolving in ways that add functionality and improve productivity; and—most importantly,
  • Two case studies of pathology groups already using digital pathology and WSI imaging to add clinical value and develop new sources of revenue.

Speaking during this webinar will be:

  • Keith Kaplan, MD, Chief Medical Officer, Corista, Concord, Mass.: For nearly a decade, Kaplan has been one of the leading commentators on the use of digital technologies and Web 2.0 capabilities in pathology. He will provide strategic context about why the FDA’s clearance of a digital pathology system for use in primary diagnosis is a trigger event for all pathology groups.
  • Liron Pantanowitz, MD, Professor of Pathology and Biomedical Informatics at the University of Pittsburgh Medical Center, Pittsburgh, Pa.: An internationally known expert on the use of digital pathology systems and whole slide imaging, Pantanowitz will give webinar participants a concise understanding of the technology’s current capabilities; how it is being used at UPMC; the lessons learned in the use of digital pathology to support UPMC’s international pathology collaborations; and what technology advances to expect in the near future.
  • Dan Angress, for ClearPath Derm of Dayton, Ohio, and President of Angress Consulting, LLC, Los Angeles, Calif.: This is a fascinating case study of how ClearPath Derm is using digital pathology capabilities to support added value services for its referring physicians that, most importantly, generate additional revenue for the pathology group.
  • Isaac R. Grindeland, MD, Gastrointestinal Pathology, Incyte Diagnostics, Spokane Valley, Wash.: This regional pathology super-group has 40 pathologists, four anchor locations, and contracts with multiple hospitals. Grindeland will explain how Incyte leverages its digital pathology capabilities to improve productivity and performance, while better meeting the needs of its hospital and physician clients.

Preparing Pathology Groups for Disruptive Potential of DB, WSI

Because of the potential for digital pathology systems and whole slide imaging to disrupt many long-established clinical practices, while at the same time creating new financial winners and losers among the nation’s pathology groups, it is imperative that pathologists and practice administrators gain the necessary knowledge to prepare their groups. Armed with these insights, they then can develop timely and appropriate strategies to ensure their group’s clinical excellence and financial sustainability moving forward.

For details about the August 17 webinar and to register, use this link (or copy this URL and paste it into your browser: https://ddaily.wpengine.com/webinar/primary-diagnosis-with-digital-pathology-systems-and-whole-slide-images-what-every-pathologist-needs-to-know-why-it-will-be-disruptive-and-how-innovative-pathology-groups-are-already-making-money-w).

—Michael McBride

Related Information:

Primary Diagnosis with Digital Pathology Systems and Whole Slide Images: What Every Pathologist Needs to Know, Why It Will Be Disruptive, and How Innovative Pathology Groups Are Already Making Money with DP

FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

Whole Slide Imaging In Pathology: Advantages, Limitations, and Emerging Perspectives

Digital Images and the Future of Digital Pathology, Liron Pantanowitz, MD

Philips Awarded FDA Clearance for Digital Pathology Solution for Primary Diagnostic Use

What Does FDA Approval of a Digital Pathology System for Use in Primary Diagnosis Mean for the Pathology Industry? New Dark Daily Webinar to Provide Answers and Insights for Pathologists and Pathology Practice Administrators

Dark Daily Story on Pathology 2.0 and Digital Pathology Blog

 

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