Lab-on-skin is the latest concept to join the lab-on-a-chip, lab-in-a-needle, and lab-on-paper field, as researchers continue to seek ways to miniaturize medical laboratory tests
Move over, lab-on-a-chip and lab-on-paper. There’s a new diagnostic technology in research labs that is gaining credibility. It is called lab-on-skin technology and some scientists are quite excited about how it might be used for a variety of clinical purposes.
A recent story published in ACS Nano titled, “Lab-on-Skin: A Review of Flexible and Stretchable Electronics for Wearable Health Monitoring,” reviews the latest advancements in lab-on-skin technology. It provides an overview of different research initiatives incorporating lab-on-skin technologies.
From telehealth to precision medicine to point-of-care mobile devices, anatomic pathologist and clinical laboratories are about to be challenged with new diagnostic technologies. These technologies are intended to streamline the workflow between physicians and medical laboratories while improving access to patient data and medical laboratory test results.
Of all the mobile devices designed to support medical care, no technology may have more potential to change the pathology profession than nanotechnology-based diagnostic devices. Whether lab-on-a-chip, lab-in-a-needle, or lab-on-paper, these miniature laboratories are so small dozens can be carried in a pocket.
Most importantly, for certain diagnostic tests, some of these devices being developed hope to deliver full-size-lab quality results accurately and inexpensively, even in rural regions and areas with little or no resources, such as electricity or water. (See Dark Daily, “Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?” September 9, 2016.)
Now, researchers have demonstrated that even biomarkers within human skin can be tested by medical wearable devices. “Lab-on-skin” has entered the pathology vernacular.
Lab-on-Skin Constantly Measures Physiological Data
According to ACS Nano, lab-on-skin devices are small electronic patches worn directly on the skin that noninvasively measure a variety of physiological data. These flexible gadgets can interpret information including:
The image above from the ACS Nano article demonstrates various lab-on-skin devices, including: an NFC tattoo with a bare die chip mounted on an acrylic adhesive film; a soft radio sensor with commercial chips encapsulated in a fluid/ecoflex package; and, a sweat sensor on silicone foam. Each of these devices could be capable of delivering actionable diagnostic data to anatomic pathologists and clinical laboratories. (Image copyright: ACS Nano.)
Lab-on-skin technology can be utilized to read electrophysiological signals typically measured by electrodes placed on various parts of the body, such as:
The direct connection between the patches and the skin allows for continuous and precise data collection without the threat of drying out that comes with traditional electrodes.
Because it is the largest organ in the body, skin provides a perfect pathway to convey biological information originating from various parts of the body, such as inner organs, muscles, blood vessels, and the dermis and epidermis.
The ACS Nano article discusses advancements in the designs and materials used for lab-on-skin patches. In addition to the term “lab-on-skin,” these devices may also be referred to as electronic skin, epidermal electronics, and electronic tattoos. They have untapped potential in a variety of clinical applications, including:
For example, researchers at the University of Illinois at Urbana-Champaign have created an epidermal nanotechnology device that utilizes sensors and wireless interfaces to measure ultraviolet (UV) exposure, a risk factor for skin cancers.
“Our goal with this research is to establish a set of foundational materials and device designs for systems that can improve health outcomes by providing information on UV exposure,” John A. Rogers, PhD, and Professor of Materials Science and Engineering and Professor of Chemistry told Nanowerk Spotlight.
Nanotechnology employs extremely small particles performed at the nanoscale (about 1 to 100 nanometers). This field is emerging as a vital element behind cutting-edge innovations in medicine and healthcare.
“We developed new chemistries that yield color changes that quantitatively relate to total exposure dose, separately in both the UV-A and UV-B regions of the solar spectrum,” explained Rogers. “Our formulations have the additional advantage that they provide soft, low modulus mechanics to enhance comfort and biocompatibility with the skin surface.”
Mini-Laboratory Devices Could Push Pathology Data to Clinical Laboratories
The combination of using lab-on-skin devices with nanotechnology can provide researchers and medical professionals a multifunctional and valuable tool for health monitoring and the diagnosis of diseases. However, more research and clinical studies are needed to establish the validity of using lab-on-skin devices in healthcare applications.
Nevertheless, clinical laboratories and pathology groups will be handling more data in the future, generated by these miniature laboratory devices. Their usefulness, especially in challenging healthcare environments, is only beginning to be fully discovered.
At institutions such as University of Texas Medical Branch, Galveston, and Vanderbilt University Medical Center, pathologists are using diagnostic management teams to improve patient outcomes while lowering the medical costs
In simplest terms, a diagnostic management team (DMT) is described by pathologist Michael Laposata, MD, PhD, as “involving a group of experts who meet daily and focus on the correct selection of laboratory tests and the interpretation of complex test results in a specific clinical field. Typically, DMTs are led by pathologists focusing on the diagnosis of a specific group of diseases, along with physicians and other lab experts involved in the disease or health condition that is the focus of the DMT.”
How Pathologists Use Diagnostic Management Teams
“What differentiates a DMT are two changes from the classic diagnostic pathway,” continued Laposata. “First, the ordering physician gets assistance in selecting the correct tests. This can be done in several ways, such as creating expert-driven algorithms that are updated regularly to manage utilization of laboratory tests and dramatically minimize overuse and underuse. Use of such algorithms with reflex testing makes it easy for treating healthcare providers to order the right tests and only the right tests.
“The second key difference in this new diagnostic pathway is that, within the DMT’s specific clinical context, an expert-driven, patient-specific interpretation of the test results in a specific clinical context is generated by the members of the DMT,” he said. “This requires the knowledge of a true expert—not someone who may have a general idea about the meaning of a particular laboratory test result—and the participation of someone to help that expert search the medical record for relevant data to be included in the interpretation.
DMTs Typically Organized to Support Specific Diseases or Health Conditions
He pointed out that the DMT has a rather simple organization. There is a front-end and a back-end. The front-end starts when “physicians order tests by requesting evaluation of an abnormal screening test or clinical sign or symptom,” explained Laposata. “Upon receiving that request, the expert physician and colleagues in the DMT then synthesize the clinical and laboratory data and provide a narrative interpretation based upon medical evidence. This happens not only when specifically requested by the referring physician, but also for every case handled by the DMT.”
Diagnostic Management Teams are making significant contributions at the University of Texas Medical Branch (UTMB), Galveston. Pictured above, the members of UTMB’s coagulation DMT are (L-R): Jack Alperin, MD; Michael Laposata, MD; Aristides Koutrouvelis, MD; Camila Simoes, MD; Chad Botz, MD; Aaron Wyble, MD: and Jacob Wooldridge, MD. (Photo copyright: University of Texas Medical Branch, Galveston.)
The back-end of the process involves the DMT conducting an “expert-driven, patient-specific interpretation of the test results in a specific clinical context.” Here is where the participating clinical experts—supplemented by staff who conduct an informed search of the medical record to identify and collect data relevant to the diagnosis—sift through this much richer quantity of information to develop the diagnosis.
Overworked Physicians Value the Expertise, Diagnostic Accuracy of DMTs
Laposata points out that individual physicians who already may be overworked in their daily routines generally welcome the help of DMT experts who are up-to-date on the current literature, and who have decades of experience in these diseases and health conditions. He likes to point out that, in coagulation alone, a physician could have as many as 60 to 90 tests that can be ordered. He also notes that typical primary care physicians, for example, are generally not experts in selecting the best coagulation test to order for every group of symptoms, nor do they know how to order the most appropriate reflexive test to continue the diagnostic pathway.
Knowing how to interpret the results of the 60 to 90 different coagulation tests is equally challenging to most physicians.
Over the course of his career, Laposata has signed out more than 50,000 cases in the field of coagulation. “Every positive case that identified a diagnosis resulted in an earlier and more accurate diagnosis,” stated Laposata. “Every case negative for coagulopathy allowed the treating healthcare provider to focus on a diagnosis other than one related to bleeding and thrombosis.”
Using Clinical Laboratory Data to Improve Patient Outcomes, Reduce Costs
There are other reasons why a growing number of medical lab administrators and clinical pathologists believe that DMTs are the right solution at the right time. One reason is the steady reduction in reimbursement from Medicare and private payers. Another is the trend to measure and publish the quality metrics of hospitals and individual physicians.
There are ever more quality metrics that include diagnostic accuracy and total cost per healthcare encounter. Diagnostic Management Teams are proven to improve diagnostic accuracy and ensure the patient gets the right therapy faster. Both of these benefits contribute to substantial reductions in the cost per healthcare encounter.
Pathologists and clinical laboratory professionals interested in learning more about diagnostic management teams have two opportunities.
At the Galveston Island Convention Center on Feb. 6 -7, 2018, the second annual Diagnostic Management Team Conference will take place. Last year, several hundred-people attended. Information can be found at: http://www.dmtconference.com/.
Special Webinar on Diagnostic Management Teams on January 17
During this valuable webinar, you’ll hear from three experts. First to speak will be Michael Laposata, MD, PhD. He will provide you with a detailed overview of DMTs, including:
How to assemble the right team;
How to engage with referring physicians; and,
How to work through individual cases.
Laposata will introduce you to the structure and organization of effective diagnostic management teams, organized around a specific disease or health condition and made up of pathologists, other lab scientists, and physicians who are expert in their particular clinical field. The objective of the DMT is to meet daily with the goal of coming up with faster, more accurate diagnoses in support of a patient’s care team.
Experience from a Diagnostic Management Team Focused on the Liver
Next to speak will be Heather Stevenson-Lerner, MD, PhD, a liver and transplantation pathologist and Assistant Professor, Department of Pathology, UTMB. She will discuss a DMT organized around diseases of the liver. This is a useful, step-by-step description of an effective DMT, illustrated with case studies that demonstrate how diagnostic management teams can make a positive and substantial contribution to improving individual patient outcomes.
The webinar’s third presenter is Christopher Zahner, MD, a resident pathologist at UTMB. He will share how to pull together all the information needed to support DMT interpretations. From the electronic health record (EHR) system to other overlooked sources of useful data, Zahner will explain the most productive ways to assemble any information that will be useful to the diagnostic management team and that will make a positive difference in patient care.
To register for the webinar and see details about the topics to be discussed, use this link (or copy and paste this URL into your browser: https://ddaily.wpengine.com/webinar/using-diagnostic-management-teams-to-add-value-with-clinical-laboratory-tests-and-pathologists-expertise).
This is an essential webinar for any pathologist or lab manager wanting to put the lab front and center in contributing clinical value in ways that directly improve patient outcomes while reducing medical costs. With hospital lab budgets shrinking and fee-for-service payments being slashed, the time is right for your lab team to consider how organizing diagnostic management teams can be the perfect vehicle to demonstrate why clinical lab tests and expertise can be a diagnostic game-changer within your hospital or health system.
And don’t forget, your participation in this webinar can be the foundation for a highly-successful effort to collaborate with physicians and clinical services, to the benefit of both the parent hospital and individual patients. That makes this webinar the smartest investment you can make for crafting your lab’s test utilization and added-value programs in support of clinical care.
University of Turin study in Italy shows under-vacuum sealing systems reduce exposure to formaldehyde by 75% among nurses handling tissue biopsy specimens during surgery
Histology technicians and anatomic pathology (AP) laboratories regularly handle dangerous chemicals such as formaldehyde. They understand the risks exposure brings and take precautions to minimize those risks. However, in operating suites worldwide, nurses assisting surgeons also are being exposed to this nasty chemical.
Nurses must place biopsies and other tissues into buckets of formaldehyde to preserve the tissue between the operating room (OR) and histology laboratory. Formaldehyde, along with toluene, and xylene, is used to process and preserve biopsy tissue, displace water, and to create glass slides. It is an important substance that has long been used to maintain the viability of tissue specimens. Thus, exposure to formaldehyde among nurses is well-documented.
According to a National Academy of Sciences report, formalin, a tissue preservative that is a form of formaldehyde, has been linked to:
Now, motivated by increasing formaldehyde regulations in Europe, as well as the need to increase awareness of exposure risks, the University of Turin (Unito), and other hospitals in Italy’s Piedmont region, conducted a cross-sectional study of 94 female nurses who were being potentially exposed to formaldehyde.
Researchers Aim for “Formalin-Free” Hospitals
The Unito study showed that nurses using an under-vacuum sealing (UVS) system in ORs are exposed to levels of formaldehyde 75% lower than those who did not use the system. This study differs from other similar tests because the level of exposure is not just potential, due to environmental contamination, but confirmed with analytic data from specific urine analyses.
The researchers divided the nurses into two groups:
· One group immersed samples in containers of formaldehyde following standard procedures;
· The other group worked in operating rooms equipped with a UVS system.
The researchers described a UVS system that called for the tissue removed during surgery to be sealed in a medical grade vacuum bag and refrigerated at four degrees centigrade before being transferred to the lab for fixation.
One example of a UVS system is TissueSAFE plus, developed by Milestone Medical, located in Bergamo, Italy, and Kalamazoo, Mich. According to the company’s website, the system, “Eliminates formalin in the operating theatre and allows a controlled formalin-free transfer of biospecimens to the laboratory.”
The image above is from a research paper by Richard J. Zarbo, MD, Pathology and Laboratory Medicine, Henry Ford Health System. It describes “five validation trials of new vacuum sealing technologies that change the approach to the preanalytic ‘front end’ of specimen transport, handling, and processing, and illustrate their adaptation and integration into existing Lean laboratory operations with reduction in formalin use and personnel exposure to this toxic and potentially carcinogenic fixative.” (Image copyright: Henry Ford Health System/Springer International Publishing.)
Increased Scrutiny Leads to New Pathology Guidelines
In a paper published in Toxicology Research, a journal of The Royal Society of Chemistry, the researchers noted a marked difference related to the adoption of the under-vacuum sealing procedure, as an alternative to formaldehyde for preserving tissues. “Nurses, operating in surgical theatres, are traditionally exposed to formaldehyde because of the common and traditional practice of immersing surgical samples, of a size ranging between two and 30 centimeters, in this preservative liquid (three to five liters at a time) to be later transferred to a [histopathology] lab,” the authors wrote. “We evaluated the conditions favoring the risk of exposure to this toxic reagent and the effect of measures to prevent it.”
Throughout Europe, increased scrutiny has forced medical pathology associations to write new guidelines that accept alternative methods to formaldehyde-based tissue preservation methods.
“In Europe, and in Italy in particular, the level of attention to formaldehyde exposure in the public health hospital system has become very high, forcing pathology associations to rewrite guidelines,” Marco Bellini, General Manager of the Medical Division at Milestone Medical, told Dark Daily. “What makes this study unique from many other similar tests is that the level of exposure has been confirmed with data from specific urine analyses,” he added.
The main topic of these guidelines is the preanalytical aspects of specimen collection, transportation, and preservation, where the vacuum method has been indicated as a valid alternative to improve the standardization of these crucial steps in pathology. By moving the starting point for specimen fixation from the OR to the histology labs, parameters can be controlled and documented, with the main advantage of reducing formaldehyde exposure by operators at the collection point.
These guidelines will be presented at the European Society of Pathology (ESP) with the intent to extending them throughout Europe.
Toluene’s and Xylene’s Effects Studied
Formaldehyde is not the only potentially harmful substance in the clinical laboratory. As previously noted, common solvents toluene and xylene also are potentially hazardous.
Medical laboratory leaders are reminded to initiate processes that ensure safe specimen handling, transport, and processing, as well as workflow changes that eliminate chemical odors in the lab. Studies, such as those cited above, may provide information necessary to affect change.
‘Stormram 4’ fits inside MRI bore and enables ‘nearly real-time imaging guidance’ to achieve sub-millimeter precision in reaching targets
Cancer surgeons perform an estimated 1.7 breast biopsies each year, according to the American Association of Preferred Provider Organizations. This makes the procedure a significant proportion of cases referred to anatomic pathologists. This surgery, however, is time-consuming and not always accurate due to shortcomings in existing surgical technology and to human error.
Now, a 3D-printed MRI-guided robotic biopsy system under development by researchers in the Netherlands may change how biopsies are performed and lead to more accurate biopsies and breast cancer diagnoses. Successful conclusion to this research could impact surgical pathology and medical laboratories worldwide.
“The Stormram 4 is a stimulus for the entire diagnostic phase of breast cancer,” the University of Twente (UT) stated in a press release. “Medical robotics is sure to become standard procedure in hospitals in the near future.”
The robotic system, dubbed Stormram 4, would be used to remove biological specimens during an MRI scan, not unlike today’s current biopsy procedures. However, the robotic system allows for sub-millimeter precision control of a single, thin biopsy needle.
The Stormram 4 (above) breast biopsy robot, developed by researchers at the University of Twente in The Netherlands, is constructed of 3D-printed plastic that is driven by rectilinear and curved air-pressure motors. This allows it to fit inside an MRI scanner’s narrow tunnel and operate while an MRI scan is taking place. Early research indicates that this device might make it possible to more precisely biopsy breast cancer tissue during surgery, thus improving the quality of the biopsies referred to anatomic pathologists. Click on the photo above to see a video of the robot in action. (Photo copyright: University of Twente.)
Billed as the world’s smallest 3D-printed biopsy robot, Stormram 4 offers major advantages over conventional MRI-navigated biopsy techniques, according to Groenhuis. The robot offers sub-millimeter precision, which was achieved during tests conducted on models of breasts.
“The manual MRI-guided breast biopsy procedure is time-consuming and ineffective,” Groenhuis told Digital Trends. “It uses a thick needle, extracting large tissue samples, often in multiple attempts, to extract a representative biopsy sample.”
In contrast, he explained, “The robotic system can manipulate the needle more precisely toward target coordinates of the lesion inside the body, on the first attempt. This will improve the accuracy of the biopsy procedure compared to the current manual practice. Secondly, the needle insertion can be performed inside the MRI scanner itself, so that the needle can be followed under nearly real-time imaging guidance. The required time to perform the biopsy is also shorter, allowing more effective use of the MRI scanner facilities.”
Building a Robot Compatible with MRI Environment
Creating a robotic system that would be compatible with an MRI machine was the first hurdle researchers had to overcome. It meant metallic materials could not be used within the magnetic chamber of the MRI scanner. Researchers turned to 3D printing to create the Stormram 4 entirely from plastic. And they powered the system using “rectilinear and curved air pressure motors.”
“Current robotic systems cannot be used inside the MRI due to the high magnetic field,” Groenhuis explained in the Digital Trends article, “and therefore we initiated the development of an MRI-compatible robotic system for breast biopsy.”
It took several attempts to build a version of Stormram that would fit inside an MRI bore. The fourth iteration succeeded. Operators control the robot using five-meter-long air pipes operated from outside of the scanner to prevent the metal air valves used to drive the robot from interfering with the scan.
Though the device is in its final stage of development, Groenhuis told Digital Trends the Stormram 4 will need several years of additional development and trials to receive regulatory approval.
Robotics Expected to Improve Surgical Outcomes
Stormram 4 recently won a prestigious award in the 2017 Surgical Robotic Challenge at the international Hamlyn Symposium in London, the university noted in its press release. But the Stormram 4 is not the only surgical robot making headlines. MRI-compatible surgical robots offer the promise of becoming revolutionary tools as researchers develop machines to improve a range of surgical outcomes.
These and other technology breakthroughs are changing the practice of surgical pathology. Consequently, clinical laboratories and In Vitro diagnostics (IVD) developers should expect be impacted as well.
As the still-developing pathology profession in China struggles to meet demand, 3rd-party medical laboratory groups, and university/industry arrangements, find opportunities to fill the needs of China’s hospitals
China is currently facing a severe shortage of anatomic pathologists, which blocks patients’ access to quality care. The relatively small number of pathologists are often overworked, even as more patients want access to specialty care for illnesses. Some hospitals in China do not even have pathologists on staff. Thus, they rely on understaffed anatomic pathology departments at other facilities, or they use imaging only for diagnoses.
To serve a population of 1.4 billion people, China has only 29,000 hospitals with seven million beds. Among the healthcare providers, there just 20,000 licensed pathologists, according to the Chinese Pathologist Association. By contrast, recent statistics show that the United States has a population of 326 million people with approximately 18,000 actively practicing pathologists and 5,815 registered hospitals with 898,000 beds.
The largest pathology department in China is at Fudan University Shanghai Cancer Center (FUSCC), a hospital with 1,259 beds in operation and 50 pathologists on staff. News accounts say those pathologists are expected to process 40,000 cases this year, surpassing their 2016 workload by 5,000 cases. The FUSCC pathologists are supported by a small number of supplemental personnel, which include assistants, technicians, and visiting clinicians.
Qifeng Wang, a pathologist at FUSCC, indicated that most leading hospitals in China with average or above-average pathology staffing are experiencing similar barriers as FUSCC. Large hospitals, such as:
“The diagnostic skill level at FUSCC is not that different from that in the U.S.,” Wang told Global HealthCare Insights (GHI). He added, however, that the competent skill level of their staffers is not sufficient to handle the internal workload at FUSCC plus the additional workload referred to them from other facilities.
Though not at the top of the list, as the graphic above illustrates, China is preceded only by Uganda, Sudan, and Malaysia for the number of patients per anatomic pathologist. China has approximately one pathologist per 74,000 people. By contrast, the United States has one pathologist for every 19,000 people. Studies indicate that, globally, the number of pathologists each year is shrinking. (Image copyright: Clinical Laboratory Products)
Patients Forced to Migrate to Receive Diagnoses
Because there are so few pathologists in the vast, heavily-populated country, many Chinese patients travel to major cities to increase their chances of obtaining reliable diagnosis and care, which further overwhelms the system.
The 1,530-bed Yunnan Cancer Hospital in the western city of Kunming handles more than 4,000 cases forwarded to them from other institutions annually. The 14 pathologists at the center also sometimes travel to rural communities to provide anatomic pathology services.
“It’s the complex cases that make it hard to keep up with our workload” said Yonglin Wang, an anatomic pathologist at the Yunnan Cancer Hospital, in the GHI article. The pathologists at Yunnan often refer their more demanding cases to larger hospitals to ensure the best analysis and outcomes for the patients.
Workload, Low Pay, and Lawsuits Discourage Pathology Enrollments
A logical solution to the critical shortage of pathologists in China would be to increase the number of people choosing the profession. However, medical students in the country tend to steer clear of surgical pathology due to the excessive workload, lower pay and status, and the threat of lawsuits relating to improper diagnoses.
To address the demand, a private pathology industry is emerging in China. There are currently more than 300 private medical laboratories located throughout the country. The largest of these businesses is KingMed Diagnostics in Guangzhou. According to their website, the 3rd-party medical laboratory group focuses on medical testing, clinical trials, food and hygiene testing, and scientific research. They examine more than 4,000 pathology cases annually, concentrating on:
“Because pathology has a history of being undervalued in China, the country has a shortage of pathologists trained to diagnose and interpret complex test results in specialized fields of medicine,” said Scott Binder, MD, Senior Vice Chair at UCLA Health in a statement. “Our partnership gives CTI and UCLA the opportunity to save lives by changing that.”
“Our collaboration will offer the people of China oncology, pathology, and laboratory medicine services they can trust. Many of these services are not largely available in China and are needed by physicians and healthcare providers to accurately diagnose and treat their patients,” stated Dr. Sangem Hsu, President of CTI in the UCLA statement.
As the need for pathologists increases worldwide, many countries will struggle to fulfill the demand. This may create even more opportunities for enterprising medical laboratory organizations and anatomic pathology groups who have the wherewithal and determination to make a difference overseas.
Recognizing the need to serve patients with high-deductible health plans, hospital systems are opening healthcare centers in outpatient settings where patients can receive care and undergo procedures—including clinical laboratory tests—more conveniently and for less cost
Health systems are putting medical imaging services, such as MRIs, in strip malls and shopping centers as a way to make it easier for patients. Such locations can also offer lower-cost procedures because of lower overhead compared to imaging centers located in hospitals. This trend to offer patients more convenient service at a lower cost is something that clinical laboratory managers and pathologists should watch and understand.
One driver behind this trend is the growing number of Americans enrolled in High Deductible Health Plans (HDHPs), where deductibles can exceed $6,000 for individuals and $12,000 for families. With such high deductibles, patients are now keenly focused on the cost of their healthcare. Medical laboratories and anatomic pathology groups have been impacted by this trend, as more patients shell out cash to pay for walk-in procedures and providers must collect full payments for services rendered.
Hospitals and health systems recognize the increased demand for outpatient, lower-priced medical services, along with price transparency. Patients with HDHPs are one reason why hospital bad debt is growing.
Healthcare Shopping Drives Lower Costs and Convenience
Price shopping on the Internet for medical services also is becoming more popular due to the availability of online doctor and facility ratings and easily-accessible price comparisons.
There are more than 7,000 stand-alone imaging centers in the US that operate independently of hospitals. About 70% of diagnostic imaging services occur in hospital settings with the other 30% performed in outpatient facilities.
According to Amino, a healthcare transparency company based in San Francisco, the cost for an MRI can vary significantly depending on where a patient lives and what type of facility is utilized for the test. Their research found that the cost of a limb MRI can range from hundreds of dollars at a freestanding facility to as much as $4,000 at a hospital. In some states, the price difference between getting an MRI at a hospital versus a stand-alone facility was almost $2,000. The average cost of having an MRI performed in a hospital setting is $2600.
Based on data from Amino, the graphic above illustrates the wide range of prices for MRIs throughout the country, and the cost disparity between hospital and free-standing medical imaging centers. In the future, pathologists and clinical laboratory managers can expect to see the publication of similar graphs that show the variation in the cost of clinical laboratory tests and anatomic pathology procedures, not just by state, but by individual laboratories. (Graphic copyright: MBO.)
Smart Choice MRI, based in Mequon, Wis., charges a maximum price of $600 for an MRI. The company now has 17 locations in Illinois, Minnesota, and Wisconsin, but plans to have 90 facilities within the next three years.
“The rise of high deductible health plans has fueled consumers who understand their options and demand a higher level of service from their providers,” Rick Anderson, Chief Executive Officer of Smart Choice MRI told the StarTribune. “Quality, service-focused care at a fair, transparent price has never been more important.”
Anderson added that his company can handle 94% of MRI procedures in their convenient, freestanding imaging facilities.
“I think the quality is very good, but we’ve combined the cost and quality, and most importantly the convenience of being in the neighborhood where people are shopping,” Anderson said. “If you look at our Richfield (Minnesota) location, we’re literally next to SuperTarget, Caribou Coffee, Noodles and Company, and Qdoba.”
Public and Private Health Insurers Shift Payments to Free-standing Facilities
Anthem recently announced they will no longer pay for outpatient MRIs and CT scans performed at hospitals in almost all of the states where the health insurer does business. They are requiring patients to have the tests performed in free-standing imaging facilities in an effort to cut costs and lower premiums. This change could affect 4.5 million people in 13 of the 14 states Anthem serves, with New Hampshire being the exception.
Diagnostic imaging is not the only medical service transitioning to outpatient facilities.
In July, the Centers for Medicare and Medicaid Services (CMS) announced that it is considering payment approval for total hip and knee replacements performed in outpatient settings. This change could go into effect as early as next year.
According to Steve Miller, Chief Operating Officer at Ambulatory Surgery Center Association, an estimated 25-50% of joint replacements could be performed on an outpatient basis.
“There’s more and more comfort among surgeons who are coming out of residencies where they trained to do surgeries on an outpatient basis,” Miller told Modern Healthcare. “The volumes are doubling year over year.”
Surgeons Approve of Free-standing Surgery Centers
There are currently more than 5,500 ambulatory surgery centers in the country and upwards of 200 of those facilities are performing outpatient joint replacement procedures. Three years ago, there were only around 25 facilities providing these services.
In 2015, there were more than 658,000 total hip and knee replacements performed on Medicare beneficiaries, according to CMS data. In 2014, the government paid more than $7 billion for the hospitalization costs of these two procedures. The CMS estimates that the cost for uncomplicated knee replacement surgeries in 2018 will be $12,381 for an inpatient procedure and $9,913 for the outpatient rate.
Physicians feel that performing joint replacements in outpatient facilities could reduce costs by up to 50%.
“I could do maybe 20% of my Medicare patients on an outpatient basis, as long as they have the support and structure at home to help them recover,” said Matthew Weresh, MD, a physician at Des Moines Orthopedic Surgeons (DMOS) in the Modern Healthcare article. “It’s a great move by Medicare.” DMOS plans to begin performing joint replacements at an ambulatory surgery center later this year.
Pathologists would be wise to monitor this trend and anticipate how anatomic pathology services might shift towards lower-cost settings. For clinical laboratories, this trend further illustrates the need to prepare for more consumers paying cash for their medical services and seeking cost-effective, high-quality options.
