News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Text-based Appointment Reminder System Cuts Patient No-Show Rates by One-Third at California’s Largest Physician-Owned Medical Practice

Could clinical laboratories use texting to improving patient compliance with the medical laboratory test orders given to them by their doctors?

California’s largest physician-owned medical practice has employed text messaging to reduce patient no-shows. Just as other innovations such as same-day walk-in clinical laboratory testing and patient at-home self-testing made it easier for patients to comply with physicians’ lab test orders, text messaging appears to help get more patients through the doors and into doctors’ exam rooms.

At least that’s the experience at Riverside Medical Clinic (RMC) in Riverside, Calif. The multi-specialty practice has more than 170 providers who see more than 400,000 patients annually. After struggling to lower its 15% baseline no-show rate using a phone-only reminder system, RMC turned to a two-way texting appointment reminder system from Santa Barbara, Calif.-based WELL Health (WELL).

According to a case study, prior to the texting system implementation, no-shows were costing RMC more than $3 million per year. “The problem we were trying to resolve was getting a hold of our patients in an expedient manner without having to do redundant work,” Diego Galvez-Ramirez, Associate Vice President, Patient Business Services at Riverside Medical Clinic, told Healthcare IT News. “We wanted to give time back to our staff. A big frustration was not having enough time for staff to accomplish their duties.”

After RMC implemented WELL’s HIPAA-compliant text-based reminder system, front office efficiency and productivity improved, and the practice experienced a 33% decrease in appointment no-shows.

Additionally:

  • No-shows decreased from 15% to 10% within the first month of going live across the enterprise.
  • Confirmed appointments rose from 29.45% to 94.45%, translating to a savings of more than $40,000 in two months.
  • 91% of patients who confirmed via WELL presented for their visit.
  • Phone volume at RMC’s two call centers decreased by 4% to 6%.

Galvez-Ramirez suggests that healthcare providers—including clinical laboratories and anatomic pathology groups—keep pace with the realities of today’s connected world. “Most of the time, the cell phone is not used to make phone calls,” he told Healthcare IT News. “You have to adapt to the new ways that your patients want and are used to communicating.

“In our environment,” he continued, “you also have to be quick to respond to your patients. No patient wants to spend unnecessary time on a phone call. Being able to send them their appointment to their phone is not a new concept, it’s an expectation.”

Based on an Axway survey of 1,200 smartphone users aged 18-60, the graphic above supports the view that text messaging is now the preferred method of communications for most people. Could clinical laboratories employ text messaging to lower patient no-shows and increase the proportion of patients who actually show up at a patient service center to provide a specimen in response to the medical laboratory test orders given to them by their physicians? (Graphic copyright: MakingCharts.com/Axway.)

The WELL messaging app draws a patient’s information from the physician’s electronic health record (EHR) system to configure the appointment reminder. This includes appointment type, date/time, and location. Based on the patient’s preferred method, the system sends reminder messages via phone, text, or e-mail.

As Healthcare IT News noted, WELL’s competitors in the patient communication space include:

Texting Reduces No-Shows at Other Healthcare Networks

Other healthcare organizations also have replicated RMC’s success in reducing its no-show rates by moving away from telephone-based reminders.

An Athena Health study examined 54.3 million patient visits in 2015 and found no-show rates dropped to 4.4% when patients received a reminder text from their provider. By comparison:

  • Athena patients who received a phone call instead of a text failed to show up 9.4% of the time;
  • E-mail reminders resulted in a 5.9% no-show rate; and,
  • 10.5% of patients who received no form of reminder message missed their appointments. 

Is Texting Secure and HIPAA Compliant?

A 2018 poll conducted by the Medical Group Management Association (MGMA) found that 68% of healthcare organizations used text messaging to communicate with patients about appointments. But is it secure?

An MGMA article notes that according to HIPAA Journal, “Recent changes to HIPAA have introduced new rules relating to how Protected Health Information (PHI) should be communicated and many healthcare organizations and other covered entities are now at risk of financial sanctions and legal action should an avoidable breach of PHI occur.” The MGMA goes on to state that, “As text messaging is not typically a fully-secure channel for the communication of PHI, practices must be vigilant when sending information via text messages.”

With proper training and precautions, clinical laboratories and pathology groups might want to add text messaging to their patient outreach programs. Data indicate that doing so could improve patient compliance with the medical lab test orders given to them by their physicians. Industry experts estimate that for every 100 medical lab test requests written by providers, only about 60% of patients show up to provide the specimens needed for a lab to perform those tests. Improving on those numbers would help clinical laboratories and patients alike.

—Andrea Downing Peck

Related Information:

Text-based Tool Reduces Patient No-Shows by More Than Two-Thirds

Case Study: Largest Physician-Owned Practice in California Sees a 33% Reduction in No-Shows in One Month

MGMA Stat Poll Indicates Most Organizations Use Text Messaging to Communicate Appointments

Getting No-Shows to Show Up

Not Texting in Healthcare? Here’s Why You Should

Text Messaging Remains an Effective Tool for Patient Appointment Reminders

To Get Patients in the Door, Try Texting

5 Ways Home Healthcare Providers Grow by Texting Clients, Employees

California Healthline Report Finds Hospital Chargemaster Prices Fluctuate Dramatically Even Among Hospitals Located Near Each Other

Though federal law requires hospitals to publicly display their prices, including their medical laboratory test prices, the information can be confusing, hard to find, and overwhelmingly complex

Hospital chargemaster prices can vary dramatically among hospitals that share the same healthcare markets. That’s what California Healthline found in a recent survey of hospitals in Los Angeles and Oakland, Calif. The price differences were huge and could keep patients located in certain areas within those health systems from accessing critical healthcare services.

Price transparency for healthcare services is an important trend and this survey demonstrates the wide disparity in prices charged by different hospitals for the same clinical service. This is also true with clinical laboratory testing services, where the most expensive price for a routine, highly-automated lab test can be up to 20 times more than the cheapest price.

California Healthline (CHL) is a news service of the California Health Care Foundation (CHCF). CHL recently compared the chargemasters of four hospitals in the Oakland area and four hospitals in the Los Angeles area. It found huge variances in the hospitals’ price lists.

A hospital’s chargemaster lists the full prices of specific products and services billable to patients or their health plans following provider care. Although chargemaster rates differ from the lower negotiated rates insurers pay, they are a guideline for what patients without insurance, or those seeking out-of-network treatment, could pay for services.

“List prices, chargemaster prices—like a hotel room rate that you might see posted on the door of a hotel room—hardly anybody ever pays that list price,” Barbara Feder Ostrov, Senior Correspondent for California Healthline, Kaiser Health News (KHN), told NBC Los Angeles. “Usually, it’s negotiated,” she added.

Nevertheless, the price differences are considerable. A historical list of the state’s hospital chargemasters, with downloadable spreadsheets, is available on California’s Office of Statewide Health Planning and Development website.

Huge Price Differences

CHL found that the price of a liter of IV fluid ranged from $56 at Kaiser Permanente Oakland Medical Center to $383 at Cedars-Sinai Medical Center in Los Angeles. The price of a brain MRI with contrast ranged from $3,211 at Highland Hospital in Oakland, part of the Alameda Health System, to $8,793.80 at Cedars-Sinai. The cost of a complete blood count with differential ranged from $59.86 at Keck Medicine of University of Southern California (USC) to $525.46 at Cedars-Sinai. 

Even more perplexing were the ranges among hospitals located in the same cities:

Other price differences were equally confounding:

The graphics above are from California Healthline’s article, “Transparent Hospital Pricing Exposes Wild Fluctuation, Even Within Miles.” (Copyright: California Healthline/ Harriet Blair Rowan.)

Pricing Transparency Impacts Clinical Laboratories

On January 1, 2019, the Centers for Medicare and Medicaid Services (CMS) enacted a Final Rule that modifies Medicare’s payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System (LTCHPPS). The final rule requires all hospitals to list their prices for all procedures online in an area accessible to the public.

CMS also requires that the data be machine-readable, downloadable to a spreadsheet, and updated at least annually.

These lists can be lengthy, with some hospitals providing pricing for tens of thousands of procedures, services, drugs, medical devices, medical laboratory tests, and other miscellaneous items. 

The final rule has implications for clinical laboratories and anatomic pathology groups doing business with their local healthcare networks, as Dark Daily reported in “New CMS Final Rule Makes Clinical Laboratory Test/Procedure Pricing Listed on Hospital Chargemasters Available to Public.”

CMS implemented the law to ensure price transparency for healthcare consumers and to enable patients to compare prices before selecting which hospitals to use for medical treatments. The final rule, which CMS says also benefits policymakers and insurance providers, can assist patients with the budgeting of any out-of-pocket costs for care. 

“[Transparency] allows policymakers to review the prices that are out there,” Barbara Feder Ostrov (above), Senior Correspondent for California Healthline, Kaiser Health News, told NBC Los Angeles. “It lets them say, ‘These are starting prices for negotiations with government and with insurers, and maybe you’re starting a little too high. Can you really justify this price?’” (Photo copyright: Kaiser Health News.)

Transparency Can Confuse Healthcare Consumers

While listing chargemaster prices may serve a valuable purpose in price transparency, the plethora of billing data and medical codes can be confusing to healthcare consumers. Usable insight may be lacking in the multiple screens of data patients encounter.

To determine the exact cost for a healthcare encounter, a patient would need to know, locate, and calculate all the components of the visit. That could include which tests will be required, which medicines will be dispensed, and the facility fee and physician’s charges. Few people would know where to begin hunting down such information.

Thus, though chargemaster price comparisons can help patients select a facility for medical tests and services, it is important to note that chargemasters merely serve as a guideline for what hospitals intend to charge for their services. People generally do not pay those published rates.

Dark Daily previously published an e-briefing regarding the opportunities and risks for clinical laboratories and pathology groups surrounding chargemasters. It’s important to note that serious enforcement and compliance issues can impact hospitals not prepared to comply with CMS’ transparency guidelines. And medical laboratories are part of that equation.

—JP Schlingman

Related Information:

How Hospital Pricing Fluctuates

Transparent Hospital Pricing Exposes Wild Fluctuation, Even Within Miles

New Law Requires All U.S. Hospitals Post Complete Price Lists Online

Available Hospital Chargemaster Submissions

As Hospitals Post Sticker Prices Online, Most Patients Will Remain Befuddled

Fiscal Year (FY) 2019 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Acute Care Hospital (LTCH) Prospective Payment System Final Rule (CMS-1694-F)

New CMS Final Rule Makes Clinical Laboratory Test/Procedure Pricing Listed on Hospital Chargemasters Available to Public

Latest Push by CMS for Increased Price Transparency Highlights Opportunities and Risks for Clinical Laboratories, Pathology Groups

Innovative Programs by Geisinger Health and Kaiser Permanente Are Moving Providers in Unexplored Directions in Support of Proactive Clinical Care

These initiatives are a call-to-action for clinical laboratories to contribute their expertise in support of wellness programs

Two of the largest healthcare systems in America are moving in non-traditional directions to proactively address certain healthcare populations. Most recently, Kaiser Permanente announced it will be investing millions of dollars to tackle homelessness and the disease outbreaks associated with it. The health system is even investing in a housing complex in Oakland, Calif., which it hopes will help patients in that area who face housing insecurity.

Kaiser’s new direction mirrors a similar project by Geisinger Health designed to address the health of certain populations. In 2017, Geisinger launched what it calls the “Fresh Food Farmacy” for its adult diabetic and obese patients to give them access to healthy foods. Geisinger finds this service saves substantial money in downstream medical expenses because the patients are healthier.

If these programs are harbingers of things to come, clinical laboratories open to supporting such wellness programs will find opportunities heading their way.

Healthcare and Homelessness

Kaiser Permanente’s announced $200 million investment in the new program begins with a $5.2 million purchase of affordable housing in Oakland, Calif. Kaiser is working with Enterprise Community Partners and the East Bay Asian Local Development Corporation (EBALDC).

The housing complex consists of 41-units and is in an area where existing residents are at risk of displacement due to gentrification. Kaiser Permanente’s purchase means the complex will be blocked from redevelopment and will remain affordable for the residents who live there.

“Housing security is a crucial health issue for vulnerable populations,” Bernard Tyson, Chairman and CEO at Kaiser Permanente, stated in a news release. “Access to affordable housing is a key component to Kaiser Permanente’s mission to improve the health of our members and the communities we serve.”

This unusual move is part of a larger strategy to invest in the economic, social, and environmental conditions that impact the health of Kaiser’s patients. It’s also part of a greater trend toward value-based, proactive healthcare.

“We know that differences in health are striking in communities with poor social determinants of health such as unstable housing, low income, and unsafe neighborhoods,” said Richard Isaacs, MD, CEO and Executive Director of The Permanente Medical Group, in the news release. “These innovative strategies are critically important steps toward the maintenance of health improvement, consistent health outcomes, and California health equity.” (Photo copyright: Kaiser Permanente.)

Proactive versus Reactive Care

Healthcare delivery in the US is transitioning from volume-based to value-based care. The Kaiser and Geisinger projects are championing another equally critical change—proactive care instead of reactive care. This shift in priorities promises to change how health systems and healthcare providers think about healthcare delivery. And clinical pathology laboratories play a critical role in these changes.

“Specifically, in the transition from volume-based to value-based healthcare, clinical laboratories are called upon to provide programmatic leadership in reducing total cost of care through optimization of time-to-diagnosis and time-to-effective therapeutics, optimization of care coordination, and programmatic support of wellness care, screening, and monitoring. This call to action is more than working with industry stakeholders on the basis of our expertise; it is providing leadership in creating the programs that accomplish these objectives,” James M. Crawford, MD, PhD, and co-authors, noted in their paper, “Improving American Healthcare Through Clinical Lab 2.0: Santa Fe Report,” published in the journal Academic Pathology.  

Food as a Prescription

Patients encounter all sorts of challenges in addition to housing. Geisinger Health’s Fresh Food Farmacy program promises to help obese and diabetic patients who face food insecurity maintain healthy diets. Coupled with exercise, the program acts like medication in helping regulate blood sugar and improving long-term outcomes for people with diabetes.

Patients in the program are given a referral, called a prescription, by their primary care physician. Once enrolled, they receive a welcome kit that includes food measurement instruments, recipes, and nutritional information. Each week, they also receive enough food to prepare healthy, nutritious meals twice a day for five days for their families.

Enrolled patients attend weekly support groups to learn about self-management. And they complete an online wellness class to help them learn about nutrition. The program also offers free cooking and nutrition classes taught by dieticians and health coaches.

Proactive, Value-Based Care and Population Health

“With what’s happening in this nation right now, there’s never been a more important time for us to focus in on this population and to do that through a united front,” Lloyd Dean, CEO at CommonSpirit Health (formerly known as Dignity Health), told Forbes.

The housing program at Kaiser Permanente and the Fresh Food Farmacy at Geisinger are just two of the latest examples that healthcare providers are increasingly focusing on population health. The fee-for-service model of healthcare pays health systems, hospitals, and other providers, based on the number of sick they treat. These new programs, however, move the entire healthcare system toward keeping people from getting sick in the first place.

“I think there’s no doubt that we need to emphasize both health needs and social service needs, and we should be thinking about these collectively and not in silos,” Signe Peterson Flieger, PhD, Assistant Professor of Public Health and Community Medicine at Tufts University, told Forbes.

As progressive health networks such as Kaiser Permanente and Geisinger move the traditional sites and types of medical care into new settings and new directions, medical laboratory managers and personnel need to stay alert for opportunities to support innovative, new health and wellness programs in their communities.

—Dava Stewart

Related Information:

Kaiser Permanent Just Invested in a Housing Complex. Here’s What It’s Doing with It

3 Initiatives to Tackle Housing Insecurity

Improving American Healthcare Through “Clinical Lab 2.0”: A Project Santa Fe Report

Fresh Food Farmacy

The Man Who Used to Run Medicaid Has a New Idea to Make It Better 

Multiomics Genetic Research May Give Clinical Laboratories New Capabilities in the Diagnosis and Treatment of Cancers in Children

Three-platform genetic sequencing offers hope for improved pediatric oncology diagnostics and precision medicine therapies

Dark Daily has long predicted that multiomics will someday play an important role in clinical laboratory diagnostic medicine. Now, new research from St. Jude Children’s Research Hospital provides early evidence of that prediction coming to fruition. 

Scientists at St. Jude’s have discovered that performing different genetic tests on pediatric cancer patients, and then combining those test results, may help guide and improve patient care.

The research was part of a St. Jude’s project called Genomes for Kids (G4K), a study to determine how genetic information may be used to diagnose and treat pediatric cancers.  Through this project, the researchers hope to learn why tumors form in children and predict how tumors will respond to certain treatments. 

‘It’s a Whole Lot of Sequencing.’

Few tragedies are worse than cancer in children. This is where precision medicine treatments can be critical, and multiomics may play an important role in the development of new therapies.

Multiomics refers to a biological analysis approach in which multiple “omes” are analyzed together in a collaborative way to locate relevant biomarkers and functional relationships. These “omes” include:

To perform their research, the St. Jude scientists examined 253 pediatric cancer patients by conducting whole genome sequencing (WGS), whole exome sequencing (WES), and RNA sequencing of their tumors. They also looked at the WGS and WES of non-cancerous tissues extracted from the same cancer patients.

“It is a whole lot of sequencing. I admit that,” Scott Newman, PhD, Group Lead, Bioinformatics Analysis at St. Jude’s, told The Scientist.

“With results available in a clinically relevant time frame, and pricing becoming increasingly comparable to the radiology and pathology tests, WGS is becoming more accessible to pediatric oncology patients,” said Scott Newman, PhD (above), Group Lead, Bioinformatics Analysis, at St. Jude’s, in an American Society of Human Genetics (ASHG) news release. (Photo copyright: ASHG.)

As a result of their three-platform testing, the researchers discovered there was at least one finding for each patient that could be useful in providing a diagnosis, revealing risks for individual patients, or pinpointing which drugs may be most beneficial for a particular patient in nearly 200 (79%) of the cases. Such findings are at the heart of precision medicine.

The researchers also compared their sequencing results to cancer panels that use next-generation sequencing (NGS) to target specific genes or mutations relevant to a certain cancer phenotype. During this portion of the research, they discovered that the cancer panels missed 11% to 16% of actionable genes relating to diagnosis, prognosis, and treatment. 

“This is either good news or bad news, depending on how you look at it,” Newman said. “Personally, I am amazed at how well these panels do and how well they have been designed. But, if you want to know every mutation that you would probably want to report, you have to do comprehensive sequencing.”

First Multi-Platform Genomic Sequencing Study

“To our knowledge, this is the first clinical study where this comprehensive three-platform genomic sequencing approach was offered prospectively to all pediatric oncology patients,” said Kim Nichols, MD, Director, Division of Cancer Predisposition at St. Jude’s, in a St. Jude’s blog post.  

The testing costs $8,600 per patient, but is considered worth it to improve patient diagnosis, prognosis, and treatment for pediatric cancer patients.

“Compared with the cost of many other procedures that children with cancer undergo, the cost is likely comparable, or even less—for example, compared with complex surgical procedures or multiple radiology tests,” Nichols said.

In addition, the test results are available in less than 30 days, which makes them more valuable, as time can be a critical asset to cancer management.  

The scientists hope this type of three-platform genetic testing can help guide care for pediatric cancer patients. 

Because so few of the molecular lesions in pediatric cancer are targetable by specific drugs, currently it is the diagnostic and prognostic insights provided by the three-platform approach that appear most clinically impactful,” said Nichols. “From a diagnostic perspective, tumors may look the same under a microscope, but the identification of specific genetic changes can direct you to the correct diagnosis, and therefore, the most appropriate therapy. From a prognostic perspective, you will have different risk stratifications depending on results.”

The results of the research were presented at the 2018 annual meeting of the American Society of Human Genetics in San Diego last October. The St. Jude’s researchers hope that this type of research can drive wider adoption of WGS in the assessment of pediatric tumors to improve patient outcomes. Pathologists and medical laboratory scientists will want to watch for additional research findings as the team at St. Jude’s uses this approach on more pediatric cancer patients.

—JP Schlingman

Related Information:

Genome, Exome, RNA Sequencing Applied to Pediatric Cancer Cases

Genome Sequencing Found Feasible and Informative for Pediatric Cancer Treatment

Recommendations Reported at ASHG 2018 Annual Meeting

Genomes for Kids Brochure

What You’re Missing If You’re Only Sequencing Exomes or RNA

Onco-Multi-OMICS Approach: A New Frontier in Cancer Research

Metabolomics Promises to Provide New Diagnostic Biomarkers, Assays for Personalized Medicine and Medical Laboratories

Might Proteomics Challenge the Cult of DNA-Centricity? Some Clinical Laboratory Diagnostic Developers See Opportunity in Protein-Centered Diagnostics

Introducing “Salivaomics” As the Basis for Cheap, Accurate Diagnostic Tests—Administered by Your Dentist!

Aspenti Health Takes Home Grand Prize in Nation’s First Clinical Lab 2.0 ‘Shark Tank’ Competition Showcasing Added-Value Clinical Success Stories

Vermont-based clinical laboratory company integrates social determinants of health (SDH) with lab data to help doctors at University of Vermont Health Network better manage their opioid patients

Aspenti Health, a full-service diagnostic laboratory specializing in toxicology screening, has won the nation’s first ever Clinical Lab 2.0 “Shark Tank”! The competition was held May 2, 2019, in conjunction with the 24th Annual Executive War College on Lab and Pathology Management in New Orleans.

The Clinical Lab 2.0 “Shark Tank” showcased forward-thinking clinical laboratories and anatomic pathology groups that are committed to the Clinical Lab 2.0 movement, a Project Santa Fe Foundation initiative aimed at guiding laboratories from test volume to lab value models.

“We are thrilled to be recognized for our work serving the unique needs of substance use healthcare. And, most importantly, across our organization for our unyielding commitment to employing innovations to solve this [opioid] crisis,” Aspenti Health CEO Chris Powell stated in the news release.

The projects were judged on Clinical Lab 2.0 attributes, such as:

  • Risk stratification by population;
  • Closure of care gaps;
  • Lab results as early detection; and
  • Lab intervention for improved clinical outcomes.

“This project, as well as all of the other cases that were presented, were quite strong and all were aligned with the mission of the Clinical Lab 2.0 Movement,” said Khosrow R. Shotorbani, President, Executive Director, Project Santa Fe Foundation, in a news release. “This movement transforms the analytic results from a laboratory into actionable intelligence at the patient visit in partnership with front-liners and clinicians—allowing for identification of patient risks—and arming providers with insights to guide therapeutic interventions.

“Further, it reduces the administrative burden on providers by collecting SDH [social determinants of health] predictors in advance and tying them to outcomes of interest,” continued Shotorbani. “By bringing SDH predictors to the office visit, it enables providers to engage in SDH without relying on their own data collection—a current care gap in many practices. The lab becomes a catalyst helping to manage the population we serve.”

Co-Use of Opioids Tied to Social Factors

Aspenti Health’s “Shark Tank” entry—“Integration of the Clinical Laboratory and Social Determinants of Health in the Management of Substance Use”—focused on the social factors tied to the co-use of opioids and benzodiazepines, a combination that puts patients at higher risk of drug-related overdose or death. The project revealed the top two predictors of co-use were the:

  • Prescribing provider practice, and the
  • Patient’s age.
“This was a unique project because it integrated social determinants, which are a key part of our overall health and wellness, with laboratory data, which is well-defined, quantitative, and very accurate,” said Jill Warrington, MD, PhD (above), Chief Medical Officer at Aspenti Health and Assistant Professor in the Department of Pathology and Laboratory Medicine University of Vermont Medical Center, in an exclusive interview with Dark Daily. “So, combining something that is really meaningful clinically with something that is very predictive and accurate has a nice blend of strengths.” (Photo copyright: Aspenti Health.)

Myra L. Wilkerson, MD, who served on a three-judge panel tasked with selecting the winning project, said the Vermont toxicology laboratory’s entry stood out in two key areas.

“We felt their project had an application to a broader population, but also moved beyond traditional [laboratory] functions or even medicine,” explains Wilkerson, who is Chair of the Diagnostic Medicine Institute for the Geisinger Health System. “Patient advocacy groups, payers, and providers all have come to realize you can identify a disease, you can provide a treatment, but so many other things impact it, especially in this community. When it is an addiction, there are so many other factors that play into whether or not they are going to be successful in their treatment plan. And a lot of them are social things.”

Educating Care Givers and Public on Dangers of Co-Use Drug Addictions

Working in collaboration with Staple Health and the University of Vermont Health Network, Aspenti selected “co-use” for this initial lab outcome study because of the significant patient safety implications and relative simplicity of its definition—the co-presence of positive laboratory results for both opioids and benzodiazepines.

According to the National Institute on Drug Abuse, more than 30% of overdoses involving opioids also involve benzodiazepines. Aspenti’s “Shark Tank” presentation highlighted the fact that co-use of the drugs accounts for nearly 2.5% of opioid-related emergency department visits, costing the healthcare system an estimated $47.5 million per year.

Based on the study results, Aspenti Health plans to develop educational programs that warn about the dangers of co-using opioids and benzodiazepines.

“We identified geographically hotspots where co-use was more prevalent, so we can target our educational initiatives centered on those geographical locations—not just to providers, but also to families and patients—to raise awareness about co-use so the risks are mitigated collectively,” Warrington said.

Advancing the Value-based Healthcare Agenda

The Executive War College Clinical Lab 2.0 “Shark Tank” advances a conversation about the lab industry’s future that began at the inaugural 2016 Project Santa Fe meeting. Lab industry stakeholders brainstormed about the transition from volume-based to value-based healthcare, and the role laboratory-driven innovations could play in reducing total cost of care.

As healthcare shifts to a value-based reimbursement model, Wilkerson believes laboratory leaders must re-engineer their role in the continuum of care by creating meaningful clinical diagnostic insights for population health initiatives.

“What’s your executive leadership concerned about? What are your payers concerned about? What are your accrediting or regulatory bodies concerned about? What are their top priorities and how can you do something that improves patient care but helps them address their problems as well?” she asks. “That’s where you create value.”

As the Clinical Lab 2.0 Innovation Award winner, Aspenti Health will receive:

  • An invitation to speak at national lab conferences this fall;
  • A consultation with a Project Santa Fe member lab to discuss successful Clinical Lab 2.0 innovations and identify new ways to deliver more value in patient care; and
  • Publication of a case study of their Clinical Lab 2.0 project by Dark Daily or its sister publication The Dark Report.

With labs in Vermont and Massachusetts, Aspenti continues to identify opportunities for directly contributing to improvements in the care of substance abuse and pain management patients. Warrington says that with its SDH project, Aspenti plans to focus on other key laboratory outcome measures—such as treatment adherence and relapse. Next steps include integrating this work into the practices of partner doctors within the University of Vermont Health Network.

Wilkerson’s advice to other clinical laboratories is to follow Aspenti Health’s lead.  

“When you look at the national trends, the percentage of traditional fee-for-service or volume-based healthcare is going to go down to 25% of the total healthcare spend by 2021,” she points out. “The other 75% will be based on value-added services around quality metrics, efficiency, cost reduction, utilization, etc. Labs that aren’t starting to think this way now are going to be behind and at risk in the future.”

—Andrea Downing Peck

Related Information:

Aspenti Health Wins Clinical Lab 2.0 Innovation Award

First-Ever ‘Shark Tank’ on Clinical Lab 2.0 and Adding Value Happens May 2 in New Orleans: Clinical Laboratories with Innovative Services Invited to Present

Improving American Healthcare Through “Clinical Lab 20”: A Project Santa Fe Report

National Institute on Drug Abuse: Benzodiazepines and Opioids

Project Santa Fe Labs Deliver Value with Tests

Improving American Healthcare Through “Clinical Lab 2.0”: A Project Santa Fe Report

Researchers at Massachusetts General Hospital Identify Ways That CRISPR DNA Base Editors Sometimes Unintentionally Alter RNA

These “off-target” genetic alterations demonstrate that certain CRISPR base editors need further refinement in a research finding of interest to pathologists

Could CRISPR DNA-editing technology unintentionally effect RNA as well? A new study conducted at Massachusetts General Hospital (MGH) suggests that it can. Clinical laboratories doing genetic testing will want to understand why this research implies that refinements to CRISPR may be needed for it to be accurate in therapeutic applications.

For years, a huge value of CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) base editors have been their ability to edit genes or convert a specific DNA base without breaking the DNA. Now, the MGH scientists have discovered that certain CRISPR base editors may extend beyond the targeted DNA and perform unwanted edits to RNA, according to a news release.

“Most investigation of off-target base editing has focused on DNA, but we have found that this technology can induce large numbers of RNA alterations as well. This surprising finding suggests the need to look at more than just genetic alterations when considering unintended off-target effects of base editors in cells,” J. Keith Joung, MD, PhD, MGH Pathologist and Professor of Pathology at Harvard Medical School, stated in the news release.

The MGH scientists published their study in Nature.

How the MGH Researchers Found Off-Target Effects on RNA

The researchers had set their sights on developing a base editor that targets cytosine, according to the study.

“Previous studies of cytosine base editor specifically have identified off-target DNA edits in human cells. Here, we show that a cytosine base editor with rat APOBEC1 [rAPOBEC1] enzyme can cause extensive transcriptome-wide RNA cytosine deamination in human cells,” the scientists wrote in Nature.

According to the news release, when the researchers put base editors into human liver and kidney cells, they found their technology induced efficient edits at the target DNA site. However, they also discovered tens of thousands of cytosine-to-uracil edits in the cells. They found that deaminases, an enzyme that acts as a catalyst, which they used in their base editor to change DNA, also altered the RNA in the cells, Science reported.

“Base editors are still incredibly powerful tools. This is just another parameter we need to understand,” J. Keith Joung, MD, PhD (above), MGH Pathologist and Professor of Pathology at Harvard Medical School, told Science. (Photo copyright: Massachusetts General Hospital.)

The researchers developed a way to reduce the unwanted RNA edits, while maintaining the targeted DNA effects. They came up with cytosine base editor variants, which they dubbed SElective Curbing of Unwanted RNA Editing (SECURE).

“We engineered two cytosine base editor variants bearing rAPOBEC1 mutations that substantially decreased the number of RNA edits in human cells,” the researchers wrote in their study.

However, they also called for changes to how base editors are used. “For research applications, scientists using base editors will need to account for potential RNA off-target effects in their experiments,” the MGH news release notes. “For therapeutic applications, our results further argue for limiting the duration of base-editor expression to the shortest length of time possible and the importance of minimizing and accounting for potential impacts of these effects in safety assessments.”

 Other Studies Explore CRISPR

Other studies published earlier this year on mice and on rice also suggested that “modified CRISPR-Cas9 technology will need to be further refined before it can safely be used for research and therapeutic applications,” The Scientist reported.

Clinical laboratory leaders and pathologists recognize CRISPR technology is changing the way research is done for diagnosing disease as well as guiding treatment. Dark Daily has reported on key CRISPR developments over many years.

And now, though the MGH study may appear to be a set-back for CRISPR, it also may propel further research into possible therapeutic applications of CRISPR base editing. It’s a development worth watching.

—Donna Marie Pocius

Related Information:

CRISPR Base Editors Can Induce Wide-Ranging Off-Target RNA Edits

Transcriptome-wide Off-Target RNA Editing Induced by CRISPR-Guided DNA Base Editors

What Are the Key Differences Between DNA and RNA?

Powerful CRISPR Cousin Accidentally Mutates RNA While Editing DNA Target

Cytosine Base Editor Generates Substantial Off-Target Single Nucleotide Variants in Mouse Embryos

Cytosine, But Not Adenine, Base Editors Induce Genome-Wide Off-Target Mutations in Rice

Base Editors Cause Off-Target Mutations in RNA

CRISPR Base Editing, Known for Precision, Hits a Snag with Off-Target Mutations

;