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MIT Researchers Link Acidic Environments to Cancer Tumor Growth and Invasion of Healthy Tissue; Might Be Useful Diagnostic Element for Pathologists

Methods that target the causes of acidity could become part of precision medicine cancer treatments and therapies

Researchers at Massachusetts Institute of Technology (MIT) have found that acidic environments enable tumor cells to strengthen through protein production. And that when acidic surfaces extend beyond a tumor’s interior, and come into contact with healthy tissue, cancer can spread.

The results of their study will interest anatomic pathologists who review tissue biopsies to diagnose cancer and help identify the most effective therapies for cancer patients. Currently, there are no new clinical laboratory tests under development based on MIT’s research.

The researchers published their findings in the journal Cancer Research. Their paper also shared how tumor acidity can be identified and reversed.

 “Our findings reinforce the view that tumor acidification is an important driver of aggressive tumor phenotypes, and it indicates that methods that target this acidity could be of value therapeutically,” noted Frank Gertler, PhD (above), in a news release. Gertler is an MIT Professor of Biology, a member of MIT’s Koch Institute for Integrative Cancer Research, and a Senior Author of the study. (Photo copyright: MIT News.)

Acidity is a Tumor Cell’s Friend

Acidity results from lack of oxygen in tumors and enables tumor cell growth. “Acidification of the microenvironment plays established roles in tumor progression and provides a hostile milieu that advantages tumor cell survival and growth compared to non-cancerous cells,” the researchers wrote in Cancer Research.

In their study, the MIT scientists sought to learn:

  • What areas of a tumor are actually acidic?
  • How does acidosis propel cells to invade surrounding healthy tissues?

They used a nanotechnology platform called pHLIP (pH Low Insertion Peptide) to sense pH at the surface of cancer cells and then insert a molecular probe into the cell membranes. “This brings nanomaterial to close proximity of cellular membrane,” noted a research study conducted at the University of Rhode Island by scientists who developed the pHLIP technology.

Medical News Today reported that the MIT scientists used pHLIP to map the acidity in human breast cancer tumors implanted in mice. When it detected a cell in an acidic environment, pHLIP sent a small protein molecule into the cell’s membrane. The scientists found that acidosis was not confined to the oxygen-rich tumor core. It extended to the stroma, an important boundary between healthy tissue and malignant tumor cells.

“We characterized the spatial characteristics of acidic tumor microenvironments using pHLIP technology, and demonstrated that tumor-stroma interfaces are acidic, and that cells within the acidic front are invasive and proliferative,” the scientists wrote in Cancer Research.

What Stimulates Acidity and How to Reverse It?

The MIT researchers sought the reasons, beyond hypoxia, for high acidity in tumor tissue.

“There was a great deal of tumor tissue that did not have any hallmarks of hypoxia that was quite clearly exposed to acidosis. We started looking at that, and we realized hypoxia probably wouldn’t explain the majority of regions of the tumor that were acidic,” Gertler pointed out in the MIT news release.

So what did explain it? The researchers pointed to aerobic glycolysis, a “condition in which glucose is converted to lactate in the presence of oxygen,” according to an article published by StatPearls. “Cancer stem cells (CSC) within a tumor are notorious for aerobic glycolysis. Thus, extensive aerobic glycolysis has been indicative of aggressive cancer,” the paper’s authors noted.

During their study, the MIT scientists found:

  • Cells at the tumor surface shifted to aerobic glycolysis, “a type of metabolism that generates lactic acid, making way for high acidity,” and
  • Proteins—Mena and CD44—were linked with metastasis.

“Tumor acidosis gives rise to the expression of molecules involved in cell invasion and migration. This reprogramming, which is an intracellular response to a drop in extracellular pH, gives the cancer cells the ability to survive under low-pH conditions and proliferate,” said Nazanin Rohani, PhD, former postdoctoral researcher in the MIT Koch Institute for Integrative Cancer Research, and Lead Author of the study, in the news release.

Could a Reduction in Acidity Reverse Tumor Growth?

In another experiment, the researchers fed sodium bicarbonate (baking soda) to mice with breast or lung tumors. The tumors became less acidic and metastatic.  

“It adds to the sense that this pH dynamic is not permanent. It’s reversible. I think that’s an important addition to an ongoing discussion about the role of pH in tumor behavior,” said Ian Robey, PhD, in an MIT blog post. Robey is a Research Assistant Professor, Department of Medicine at the University of Arizona, and Full Investigator at the Arizona Cancer Center. He was not involved in the MIT research.

Spreading the Word on How Cancer Spreads

The MIT study is important—not only to anatomic pathologists—but also to oncologists and cancer patients worldwide. Cancer is not simple to diagnose and treat. The MIT study may provide important insights into targeting cancer care and precision medicine treatments.  

—Donna Marie Pocius

Related Information:

Acidic Environment Triggers Genes That Help Cancer Cells Metastasize

Acidification of Tumor at Stromal Boundaries Drives Transcriptome Alterations Associated with Aggressive Phenotypes

Decoration of Nanovesicles with pH (low) Insertion Peptide (pHLIP) for Targeted Delivery

How Does Tumor Acidity Help Cancer Spread?

Tumors Create an Acidic Environment That Helps Them Invade Surrounding Tissues

PAMA Price Reporting Update: Insights to Help Prepare to Meet the Requirement

Prior (2018) price reporting cycle offers lessons that can help clinical laboratory benefit administrators and personnel take an informed approach to meeting the requirements of the Protecting Access to Medicare Act of 2014 (PAMA)

With the PAMA Private Payor Price Reporting period under way, some clinical laboratories may be grappling with questions about the new requirements.

Under PAMA, applicable labs must report private payer data on selected Clinical Diagnostic Laboratory Tests (CDLTs) to CMS every three years. For the current cycle, data must be collected from Jan. 1 through June 30.

A six-month review period follows so that laboratories can assess whether the applicable lab thresholds are met. Data must be reported to the Centers for Medicare & Medicaid Services (CMS) during a three-month window starting Jan. 1, 2020, with data due by March 31, 2020.

To help clinical laboratories meet PAMA’s new requirements, CMS defines an applicable laboratory as one that answers yes to the following questions:

1) Does the lab have CLIA certification?

2) Does the lab meet the majority of Medicare threshold, which is either greater than 50 percent of Medicare payments received on CLFS and PFS (Physician Fee Schedule) by National Provider Identifier (NPI) or a hospital lab with a shared NPI bills any Type of Bill (TOB) 14x to Medicare during the six-month reporting timeframe.

3) Does the lab have a minimum of $12,500 payments received from Medicare during the six-month reporting period.

Recent Changes Draw Hospital Outreach Labs

Changes in CMS reporting requirements now include hospital outreach labs, if they meet the other criteria.

Failure to file, or filing late, incomplete, or inaccurate data can result in federal fines for laboratories—up to $10,000 a day.

Sarah Simonson, Director of Laboratory Client Management for Change Healthcare, outlines ways labs can avoid those fines and best prepare for this cycle of private payer reporting.

“Begin with the end in mind,” Simonson said. “Understand what is required and prepare for data extraction.” Simonson is one of several pros who will offer insights during a special post-Executive War College workshop geared to private payer price data reporting under PAMA.

Labs should allow ample time to review extracted data, Simonson said, as well as evaluate the data for quality assurance. It’s also important to understand login requirements and the format required to deliver the data. That means getting your IT team involved.


Trish Hankila, Chief Financial Officer of South Bend Medical Foundation, will return to the Executive War College on Lab and Pathology Management, for a special post-conference workshop on the PAMA price reporting requirement. (Photo copyright: Dark Daily)

Having learned many lessons from the previous reporting cycle, Trish Hankila, Chief Financial Officer of the South Bend Medical Foundation, recommends talking with your internal IT or vendor to ensure that accounts receivable (A/R) reports capture the required data. Review available data to ensure accuracy and completeness of data, and review the A/R report that will be used to transmit that data, she says. 

Hankila, who will also speak at the 24th Annual Executive War College post-conference workshop encourages a visit to the CMS website to obtain documents regarding the data, registration, and submission requirements.

“The Center for Medicare Management, CLFS User Manual explains in detail how to log in to the CMS portal, register the data submitter and data certifier, and the process for submitting and certifying the data,” Hankila said.

CMS will use the data collected to calculate 2021 fees for each individual laboratory Current Procedural Terminology (CPT) code.

“CMS is trying to establish fees that reflect the market value of the tests being performed, using a weighted average of the various amounts paid per CPT code by third-party payers,” Hankila said.

How to structure your data when working with your internal IT team or third-party billing will be one focus of the PAMA workshop, in addition to how to avoid the pitfalls when gathering, analyzing, and reporting lab test price data. The post-conference workshop will benefit administrators and personnel responsible for reporting PAMA data.

“What Hospital and Health Network Labs Must Know to Comply with PAMA Private Payer Price Reporting,” will take place from 8 a.m. to 5 p.m., May 2, in New Orleans.

“The takeaways include understanding PAMA, lessons learned from the prior (2018) cycle, and how to structure your request to your IT/billing department,” Simonson said.

To help attendees prepare to participate in the PAMA workshop, Hankila previewed what South Bend Medical Foundation has learned:

  • Get started early with data gathering and the reconciliation process;
  • Reconcile the data by using other reports from your A/R system;
  • Ensure you have enough time to modify programs; and
  • Do not wait until the last minute to transmit the data.

“There may be issues with registration of the submitter and certifier in the CMS portal, the CMS website, or with your data file that you have prepared for submission,” Hankila said.

More Upcoming PAMA Workshop Highlights

Elizabeth Sullivan, JD, will cover “Compliance and Regulatory Issues Associated with the PAMA Statute and the CMS Final Rule for Reporting Private Payer Lab Test Prices: Risks, Consequences, and Often-Overlooked Requirements.”

Diana Voorhees, MA, CLS, MT, SH, CLCP, CPCO, will cover “Understanding the Requirements for Reporting PAMA Private Payer Lab Test Price Data: Who Reports, What Is Reported, How to Report, When Penalties Apply, and More.”

Kyle C. Fetter, MBA, BA, will present “Key Recommendations for Reporting Your Lab’s Private Payer Price Data: Identifying Data Sources, Using Informatics Tools, Understanding Where Data is Missing or Inaccurate, and Transmitting Your Data.”

Visit executivewarcollege.com for more information and to register.

—Tammy Leytham

Related Information

Useful Lessons for Labs That Report PAMA Data

CMS PAMA Regulations Home Page

Registration for Executive War College Post-Conference Workshop

Swiss Post Medical Drone Carrying Clinical Laboratory Specimens Crashes in Switzerland

Crash into Lake Zurich of American-made drone carrying blood specimens is first setback for pioneering Swiss Post medical drone program

Medical drones shuttling clinical laboratory specimens across open terrain is an exciting reality that Dark Daily has reported on in previous e-briefings. However, the medical drone revolution experienced a setback in January when drone-pioneer Swiss Post (Switzerland’s postal service) saw one of its American-made Matternet drones crash into Lake Zurich, Switzerland.

According to a Swiss Post news release, the drone went down carrying a “non-vital” blood sample (one that had been previously analyzed). The flight was part of a recently launched pilot program transporting blood samples between Zurich’s central laboratory and the Hirslanden Klinik Im Park, a private clinic on the opposite side of Lake Zurich.

A drone can cover the 5.8-kilometres across the water in seven minutes—five times faster than an on-the-road courier, according to Swiss Post.

Zurich city police recovered the drone from the lake on January 28. However, until the cause of the accident is determined, Swiss Post has grounded all drone flights, the news release noted.

This was the first accident involving Swiss Post drones, which have successfully completed more than 3,000 flights in Lugano, Berne, and Zurich.

A drone from California-based Matternet (shown above) flies toward the opposite side of Lake Zurich in Switzerland. Swiss Post, Switzerland’s postal service, is using drones to quickly transport clinical laboratory samples between hospitals in urban areas (Photo copyright: Swiss Post.)

Christian Hegner, Director General of Switzerland’s Federal Office of Civil Aviation, is proud of his country’s contribution to the development of performance-based regulatory models for the drone industry, which are detailed in the World Economic Forum (WEF) Advanced Drone Operations Toolkit. “The goal of this toolkit is to enable regulators to learn from the innovative policy experiments occurring around the world and empower them to adopt these governance models that accelerate the promise of drones for all,” he states in the toolkit.

“We have learned a lot in the last few years,” Hegner told  SWI swissinfo.ch (SWI), the international reporting service of the Swiss Broadcasting Corporation (SBC). “Sharing our expertise and learning from other countries will help speed up and extend drone security around the world.”


Timothy Reuter, Head of Drones and Tomorrow’s Airspace at the World Economic Forum, and co-author of the Advanced Drone Operations Toolkit, believes it is only a matter of time before ecommerce and medical drones rule the skies. “We are witnessing the beginning of a logistics revolution; one that will redefine the way goods and people are moved around the world, and one that will drive social change alongside societal impact,” he states in the Advanced Drone Operation Toolkit. (Photo copyright: Quartz.]

Might Medical Drones in the US Carry Clinical Laboratory Samples?

Now that the World Economic Forum has issued its “toolkit,” which is aimed at helping countries replicate the pioneering success of Switzerland and Rwanda in transporting blood and other medical specimens using unmanned aerial vehicles (drones), could the use of medical transport drones to deliver clinical laboratory specimens throughout the US could take off as well?

Maybe. Creation of such a medical transport network using drones faces headwinds from aviation industry regulators.

According to National Public Radio (NPR), the Federal Aviation Administration (FAA) has expressed concerns about authorizing the widespread use of drones in already congested airspace.

“We haven’t seen the [FAA] be interested in a one-off approach,” Susan Roberts, PhD, told NPR. Roberts is Global Commercial Head of Innovation and Sales Excellence for Panasonic Avionics, and founder and former policy leader at AiRXOS, a General Electric subsidiary focused on drone infrastructure technology. “It doesn’t do anybody any good for a delivery company to be able to fly from two specific points if they can’t then scale that over and over again,” she noted.

Nevertheless, in its Advanced Drone Operations Toolkit, the WEF argues a “unique opportunity exists today to harness the revolutionary power of drones and autonomous aerial mobility,” and it provides a regulatory framework to do so.

The crash of the Swiss Post drone carrying clinical laboratory samples is a setback. However, it is also a learning experience. As Swiss Post and other nations gain experience, and as regulatory models become established, anatomic pathology groups and medical laboratories worldwide may finally have a solution for delivering specimens over long distances while maintaining the integrity of samples.

—Andrea Downing Peck

Related Information:

Drone Carrying Blood Falls in Lake During Testing

Crashed Swiss Post Drone Recovered

Advanced Drone Operations Toolkit: Accelerating the Drone Revolution

Drones: Swiss Post to Regularly Transport Lab Samples Across the Zurich Lake Basin in Future

Medical Cargo Could be the Gateway for Routine Drone Deliveries

Drones Used to Deliver Clinical Laboratory Specimens in Switzerland

California Company Creates ‘Uber for Blood’ to Speed Transport of Life-Saving Medical Supplies and Blood Products in Rwanda

Duke University Study Suggests the Human Body Starves Gut Bacteria to Produce Beneficial Results

Human microbiota is linked to many diseases but could hold the key for advanced clinical laboratory tests and targeted precision medicine therapies

Study of the human microbiome continues to provide understanding and knowledge regarding gut bacteria and its many benefits, and incites development into new clinical laboratory tests. However, a new study reveals that our bodies might also put gut bacteria under stress leading to better health.

Traditionally, scientists believe the human gut is a hospitable environment that allows bacteria to thrive. However, microbiologists may be interested in a study by Duke University School of Medicine (Duke) that suggests the relationship between humans and their microbiomes may be adversarial as well.

In fact, the study found that human hosts are starving their microbes of nutrients and forcing them to compete for food for the benefit of the host.

“There appears to be a natural pecking order to the bacteria and us,” noted Lawrence A. David, PhD, Assistant Professor, Department of Molecular Genetics and Microbiology at Duke University School of Medicine, in an article Duke posted on Phys.org. “In a way it’s not surprising that we, the host, should hold more of the cards.”

Duke researchers published the results of their study in Nature Microbiology, an online peer-reviewed scientific journal.

Could Nitrogen Impact Gut Bacteria?

The human microbiome consists of hundreds of different types of bacteria and other various tiny organisms, such as viruses and fungi. When combined, the microbes in the human gut weigh approximately three pounds or about the same as the brain.

The theory behind Duke’s study was that the human microbiome is an ecosystem comprised of various entities that compete for resources, and which are often constricted by nutrients, such as nitrogen or phosphorus.

To perform the study, Aspen Reese, PhD, a PhD candidate at Duke during the study and now a Junior Fellow researcher at Harvard University, procured stool samples from more than 30 types of mammals. She then ground the individual samples and tabulated the number of nitrogen and carbon atoms contained within those samples.

 

The animals used for the study included wild zebras, giraffes and elephants from Kenya, domestic sheep, cattle and horses from New Jersey, and humans from North Carolina. The graphic above shows how “carbon-to-nitrogen ratios in poop vary between animals as a result of diet and physiology. These ratios also govern the abundance of microbes in their guts.” (Image copyright: Aspen Reese/Harvard University.)

Reese discovered that the bacteria in the human gut had access to only one nitrogen atom for every 10 carbon atoms. The bacteria in other mammals’ guts had access to one nitrogen atom for every four carbon atoms. The question arose: Could nitrogen levels in the human gut impact the microbiome?

Reese performed tests on mice to determine if nitrogen levels could help regulate the microbiome. She fed the mice a diet packed with protein, which naturally contains a large amount of nitrogen. When she increased the amount of protein fed to the mice, the amount of their gut bacteria also increased. Reese then injected nitrogen directly into the bloodstream of the mice and found that some of that nitrogen ended up in their gut bacteria.

This discovery suggests the host can help save microbes in the gut by secreting nitrogen through the cells.

“Our findings support the idea that we’ve evolved a way to keep our bacteria on a leash by leaving them starving for nitrogen,” David noted on Phys.org. “It also explains why the Western diet might be bad for us. When people eat too much protein, it swamps the host’s ability to take up that nitrogen in the small intestine, and more of it ends up making its way to the large intestine, eliminating our ability to control our microbial communities.” (Photo copyright: Duke University School of Medicine.)

Antibiotics and Gut Bacteria

The team also performed a previous study regarding the effects of antibiotics on gut bacteria, which they published in June on eLife, an online open-access journal.

In that study, the researchers gave mice a five-day treatment of antibiotics. By analyzing their stool samples daily, the scientists discovered that many of the energy sources needed by microbes in the gut accumulated as bacteria was depleted. Some species of valuable gut bacteria are eliminated by antibiotics and may never return.

The researchers found that the mice had to eat each other’s stools in order for those essential microbes to return.

“People probably won’t want to do that,” David told Phys.org.

The trillions of microbes that reside in the human gut help manage almost every function of the human body. Poor gut health can contribute to a wide variety of health problems, including allergies, arthritis, dementia, diabetes, cardiovascular disease, leaky gut syndrome, and some cancers and autoimmune diseases.

Factors such as diet, sleep habits, stress levels, and the number of bacteria an individual is exposed to on a regular basis can negatively affect the microbiome.

Continuing research into the mysteries contained in the human microbiome provide valuable data about our gut bacteria. This type of information could eventually help microbiologists and clinical laboratory professionals more accurately identify diseases and health conditions and guide physicians to appropriate, and possibly targeted, precision medicine therapies for patients.

—JP Schlingman

 

Related Information:

Our Microbes Are Starving, and That’s a Good Thing

Scientists Reveal How Gut Microbes ‘Recover’ after Antibiotic Treatment

How and Why Our Bodies Starve Gut Bacteria

Loss of Microbial Gut Diversity a Threat to Health?

Microbial Nitrogen Limitation in the Mammalian Large Intestine

How Many Cells Are in the Human Body—And How Many Microbes?

Mayo Clinic Researchers Find Some Bacteria Derail Weight Loss, Suggest Analysis of Individuals’ Microbiomes; a Clinical Lab Test Could Help Millions Fight Obesity

University of Illinois Study Concludes Regular Physical Exercise Improves Human Microbiome; Might Be Useful Component of New Treatment Regimens for Cancer and Other Chronic Diseases

Researchers in Two Separate Studies Discover Gut Microbiome Can Affect Efficacy of Certain Cancer Drugs; Will Findings Lead to a New Clinical Laboratory Test?

Excessive $48,329 Charge for California Patient’s Outpatient Clinical Laboratory Testing Calls Attention to Chargemaster Rates and New CMS Price Transparency Rule

Studies show medical laboratories may be particularly hit by adjustments to hospital chargemasters as hospitals prepare to comply with Medicare’s New Transparency Rule

Recently, Kaiser Health News (KHN) published a story about a $48,329 bill for allergy testing that cast a spotlight on hospital chargemaster rates just as healthcare providers are preparing to publish their prices online to comply with a new Centers for Medicare and Medicaid Services (CMS) rule aimed at increasing pricing transparency in healthcare. The rule goes into effect January 1, 2019.

The patient—a Eureka, Calif., resident with a persistent rash—had received an invoice for more than $3000 from her in-network provider.

Though this type of allergy skin-patch testing is usually performed in an outpatient setting by a trained professional, such as an allergist or dermatologist, the patient elected to have the testing performed at Stanford Health Care (Stanford), a respected academic medical system with multiple hospitals, outpatient services, and physician practices.

The patient’s insurance plan, Anthem Blue Cross (Anthem), paid $11,376 of the $48,329 amount billed by Stanford Health Care, which was the rate negotiated between the insurer and Stanford, Becker’s Healthcare reported. The patient ultimately paid $1,561 out-of-pocket.

So, where did that $48,329 in total charges come from? Experts pointed to the provider’s chargemaster. A chargemaster (AKA, charge description master or CDM) lists a hospital’s prices for services, suppliers and procedures, and is used by providers to create a patient’s bill, according to California’s Office of Statewide Health Planning and Development (OSHPD).

Chargemasters note high prices beyond hospitals’ costs and may be considered jumping off points for hospitals to use in invoicing payers and patients, RevCycleIntelligence explained.

Hospital representatives will negotiate with insurance companies, asking them to pay a discounted rate off the chargemaster list. A patient with health insurance accesses care at that negotiated rate and perhaps has responsibility for a share of that amount as well.

However, an out-of-network patient, uninsured person, or cash customer who receives care will likely be billed the full chargemaster rate.

In a statement to KHN, Stanford explained that the California woman’s care was customized and, therefore, costly: “We conducted a comprehensive evaluation of the patient and her environmental exposures and meticulously selected appropriate allergens, which required obtaining and preparing putative allergens on an individual basis.”

Johns Hopkins researchers Ge Bai, PhD, CPA (left), and Gerard Anderson, PhD (right), authored a study published in Health Affairs that shows “Hospitals on average charged more than 20 times their own costs in 2013 in their CT scan and anesthesiology departments.” Hospitals with clinical laboratory outreach programs will want to consider how their patients may respond as new federal price transparency requirements make it easier for patients to see medical laboratory test prices in advance of service. (Photo copyright: Johns Hopkins University.)

Now is a Good Time for Clinical Laboratories to Make Chargemaster Changes

Some organizations, such as the Healthcare Financial Management Association (HFMA), are calling for chargemaster adjustments as part of a comprehensive plan to improve transparency and lower healthcare costs. This falls in line with the new CMS rule requiring hospitals to post prices online starting Jan.1, 2019.

In fact, hospital medical laboratories, which cannot distinguish their services from competitors, may be impacted by the new CMS rule perhaps more than other services, the HFMA analysis warned.

“The initial impact for healthcare organizations, if they have not already experienced it, will be on commoditized services such as [clinical] lab and imaging. Consumers do not differentiate between high and low quality on a commoditized service the same way a physician might, which means cost plays a larger role in consumers’ decision making.” That’s according to Nicholas Malenka, Senior Consultant, GE Healthcare Partners, and author of the HFMA report. He advises providers to do chargemaster adjustments that relate charges to costs of services, competitors’ charges, and national data.

Medical laboratory leaders also may want to take another look at the opportunities and risks for labs suggested in an earlier Dark Daily e-briefing on the Medicare requirement. (See, “Latest Push by CMS for Increased Price Transparency Highlights Opportunities and Risks for Clinical Laboratories, Pathology Groups,” August 8, 2018.)

Are Chargemaster Charges Truly Excessive? Johns Hopkins Researchers Say ‘Yes!’

Most hospitals with 50 beds or more have a charge-to-cost ratio of 4.32. In other words, $432 is charged when the actual cost of a service is $100, according a study conducted by Johns Hopkins University and published in Health Affairs.

The researchers also noted in a news release about their findings titled, “Hospitals Charge More than 20 Times Cost on Some Procedures to Maximize Revenue,” that:

  • Charge-to-cost ratios range from 1.8 for routine inpatient care to 28.5 for a CT scan; and,
  • Hospitals with $100 in CT costs may charge an uninsured patient or out-of-network patient $2,850 for the service.

“Hospitals apparently markup higher in the departments with more complex services because it is more difficult for patients to compare prices in these departments,” lead author Ge Bai, PhD, CPA, Associate Professor at Johns Hopkins Carey Business School, noted in the news release.

“(The bills for high charges) affect uninsured and out-of-network patients, auto insurers, and casualty and workers’ compensation insurers. The high charges have led to personal bankruptcy, avoidance of needed medical services, and much higher insurance premiums,” co-author Gerard Anderson, PhD, Professor of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health, stated in the news release.

Legal Issues Possible for Hospitals, Medical Laboratories, Other Providers

Still another study published in the American Journal of Managed Care (AJMC) explored the legality of “surprising” uninsured and out-of-network patients with bills at the chargemaster rates. It found that contract law supports market-negotiated rates—not chargemaster rates that do not reflect actual costs or the market.

“Patients and payers should know that they are under no obligation to pay surprise bills containing chargemaster rates, and state attorneys generally can use the law to prevent providers from pursing chargemaster-related collection efforts against patients,” the researchers wrote.

Labs Need to Get Involved

Clinical laboratory leaders in hospitals and health systems are advised to reach out to hospital chargemaster coordinators to ensure the chargemaster, as it relates to the lab, is inclusive, accurate, and in sync with competitive market data. Independent medical laboratories may want to similarly check their chargemasters to see how their lab test prices compare to the prices charged by other labs serving the same community.

—Donna Marie Pocius

Related Information:

That’s a Lot of Scratch: The $48,329 Allergy Test

Allergy Tests

Six Things to Know About a Woman’s $48K Allergy Test

The Role of the Hospital Chargemaster in Revenue Cycle Management

Why Your Access Strategy Demands Pricing Transparency

CMS Proposes Changes to Empower Patients and Reduce Administrative Burden

US Hospitals Are Still Using Chargemaster Markups to Maximize Revenue

Hospitals Charge More than 20 Times Costs on Some Procedures to Maximize Revenue

Battling the Chargemaster: A Simple Remedy to Balance Billing for Unavoidable Out-of-Network Care

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

 

Innovative Clinical Laboratories of Hospitals and Health Systems Now Working to Standardize and Rationalize Lab Tests and Lab Services

It’s the next wave in the long-running trend of hospital laboratory consolidation, as the need to trim costs and support thriving medical laboratory outreach programs continues

There’s an important new development in the hospital/health system sector of the clinical laboratory industry that continues the longstanding trend of consolidating multi-site lab operations. It is to rationalize and standardize medical laboratory operations across all lab sites within the health system. Effectively, this standardization trend represents the next cycle of clinical laboratory consolidation.

One recent example of this trend can be found at Atrium Health, the hospital health network based in Charlotte, N.C. (formerly known as Carolinas HealthCare System until earlier this year). Becker’s Hospital Review states that Atrium Health is the “seventh largest nonprofit system in the country based on number of acute-care hospitals (35).”

Creating Standardized Medical Laboratory Testing Services at Multiple Sites

Over the past four years, the clinical laboratory team at Atrium Health has worked to design, build, and operate a new, state-of-the-art core laboratory. At the same time, there were sequential projects to integrate the lab testing services and operations of nine other medical lab sites within the health system to better align the test menu, lab instruments, and workflow at these sites with the activities of the core laboratory.

According to Modena Henderson, MHA, the Vice President of Laboratory Services at Atrium Health, in an interview with Dark Daily, there were multiple primary goals in this project to rationalize and standardize lab testing at all the participating lab sites. They include:

  • Standardizing lab test methodologies, reference ranges, and test menu;
  • Standardizing analyzers and test platforms across all labs;
  • Using Lean, Six Sigma, and other process improvement methods to streamline workflow and reduce test turnaround time;
  • Improve productivity of lab staff;
  • Increase quality while reducing or eliminating unproductive activities;
  • Using real-time analytics middleware to keep lab management informed on a daily basis, and,
  • Collaborating with emergency departments, wards, and outreach physicians to deliver more value with clinical lab testing services.

Using the ‘Three Ps of Project Management’ Approach in Health System Labs

The centerpiece of this program of lab rationalization and consolidation was the design and build-out for a new core clinical laboratory facility. Henderson said her team followed the principals of the “Three Ps of Project Management”—People, Process, Performance—to model the new lab facility, then guide how it was constructed and brought into daily clinical service.

“The Atrium Health laboratory regionalization project is an example of the next step that many innovative hospital laboratories are taking,” stated Robert L. Michel, Editor-in-Chief of The Dark Report. “Every lab has the same double challenge. First is financial. Hospital lab budgets are shrinking as growth in inpatient admissions slows. Outreach revenues are declining as Medicare and private payers slash lab test prices.

“Second, labs must come up with the capital needed to acquire and deploy the expensive and sophisticated new genetic and molecular tests that physicians and patients want,” he continued. “Hospital and health network labs must offer these new tests to keep their parent organizations at the cutting edge of clinical care.

Clinical Labs See Value in Standardizing Test Methodologies, Menus

“Thus, it is logical for the clinical labs of health networks to begin the process of rationalizing and standardizing their test menus, methodologies, and analyzers at every site within the system that performs medical lab testing,” emphasized Michel. “This is a development that we have watched gather momentum.”

Keynote Speaker Robert L. Michel, Editor-in-Chief of The Dark Report and Dark Daily will discuss how clinical laboratories of hospitals and health networks are rationalizing and standardizing their medical laboratory testing services to achieve the goals of managing lab costs, boosting quality, and increasing lab outreach revenue. The 12th annual Lab Quality Confab takes place on Oct. 9-10, 2018, at the Hyatt Regency Atlanta. (Photo copyright: The Dark Report.)

Michel offered two examples of sizable programs to rationalize and standardize clinical lab tests and services across a large health system. One is in Michigan, at Ascension Health. The other is in the Canadian Province of Québec. Both are large and ambitious undertakings, both in the number of lab sites involved and the large geography served by these clinical laboratories.

Consolidation Project in Québec involves 123 Clinical Lab Facilities

Québec’s provincial health system wants to consolidate 123 clinical laboratories in the province into 11 groups (clusters) of labs. Each lab group, or cluster, will have a core lab and rapid response labs. Test menus and methodologies will be standardized throughout the province. In an interview with The Dark Report, Ralph Dadoun, PhD, Project Director for Optilab Québec, plans to accomplish the consolidation without adding costs.

In Michigan, Ascension’s clinical lab leadership is working to integrate and standardize the labs that are operated by seven system organizations. This includes 14 hospitals and 18 existing laboratories located throughout the entire State of Michigan. In an interview with The Dark Report, Carlton Burgess, MSM, Vice President of Laboratory Services at Ascension Health’s St. John Providence Clinical Pathology Laboratory in Grosse Pointe Woods, Mich., stated that the goal is to have all the labs in the state work together in a seamless, integrated fashion.

Regional Lab Integration at North Carolina’s Biggest Health System

“To achieve this, the labs will be linked in four regions—a process we describe as regional integration,” explained Burgess. “Each region has a core lab and rapid response labs and each region will be responsible for building lab volume through increased outreach testing. In addition to changing how labs serve each region, our statewide standardization project has three objectives:

  • “Repatriate existing send-out lab testing back into Michigan;
  • “Establish standard test menus for each facility; and,
  • “Renew each lab’s focus on growing lab outreach business.

“Every lab administrator and pathologist working in hospital and health network laboratories should be tracking this new trend of regionalization and standardization of hospital labs,” observed Michel. “That’s because labs already moving down this path are setting new standards for the entire clinical laboratory industry. This goes beyond cost and productivity, because these labs are putting the systems in place that will allow them to deliver more value to physicians and thus be paid more for that value by private health insurers.”

Innovative Lab Leaders to Speak at Lab Quality Confab in Atlanta

Lab leaders from Ascension Health will be keynote speakers at the upcoming 12th Annual Lab Quality Confab that takes place on October 9-10, 2018, at the Hyatt Hotel in Atlanta. They will also conduct multiple learning sessions to share their successes and lessons learned in building a new core laboratory and using that as a foundation to rationalize and standardize test methods, reference ranges, menus, lab automation, and analyzers at every clinical lab facility in the Ascension Health system. Sessions by Ascension Health lab leaders include:

  • Leveraging Lean to become a Best-in-Class Lab Performer: How We Built and Automated a New Core Lab while Integrating Lab Operations and Helping Staff Embrace a New Culture; Modena Henderson, Vice President, Laboratory Services, and, Steven Harris, Assistant Vice President, Atrium Health.
  • Achieving Standardized, High-Performance Lab Testing Services at Multiple Hospitals Using Lean Methods and Effective Engagement with Lab Staff and Nurses; Gary Catarella, MBA, MT(ASCP), Assistant Vice President, Hospital Operations, Atrium Health.
  • Lessons We’ve Learned in Our Step-by-Step Journey to Transform Lab Operations and Integrate Testing across All Sites: Engaging Staff, Sustaining Change, Working with Vendors and Consultants—Interactive Roundtable Discussion; Modena Henderson, Vice President, Laboratory Services; and, Steven Harris, Assistant Vice President, Atrium Health.

Using Lean, Six, Sigma, ISO 15189 in Clinical Laboratory Operations

Lab Quality Confab this year features 60 speakers and 40 presentations from lab administrators, pathologists, and other lab managers on their successes and innovations using Lean, Six Sigma, ISO 15189, and other process management methods. You can view the full agenda here (or copy and paste this URL into your web browser: https://www.labqualityconfab.com/agenda).

This year’s Lab Quality Confab is on track to be the largest in its 12-year history. Limited spaces are still available. To ensure your place, register today at: https://www.labqualityconfab.com/register (or copy and paste this URL into your web browser: https://www.labqualityconfab.com/register).

Also, you can bring your lab team and make this Lab Quality Confab a group learning opportunity. When you bring four or more from your organization, each can register for $695 for this two-day learning event. One benefit you’ll gain from bringing your team is that it will give them the knowledge, the tools, and the confidence to help your lab reduce costs without compromising quality, while supporting sustained revenue growth from your hospital lab’s successful outreach program.

—Michael McBride

Related Information:

Full Agenda and Other Details for 12th Annual Lab Quality Confab

To Register for 12th Annual Lab Quality Confab

10 Things to Know about Atrium Health, Formerly Carolinas HealthCare System

Québec’s Laboratory Consolidation Plan Aims to Save $13.5 Million: Optilab Québec to move 123 labs into 11 lab groups

Michigan’s Ascension to Standardize Labs Throughout the State: Goals Are Common Test Methods, Menus, Practices

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