Nov 22, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Industry analysts speculate that Apple might be planning to enter the EHR and healthcare related markets by transforming mobile technologies into gateway devices connected to providers’ EHR systems and patient data
Imagine a mobile device that monitors vitals while connected in real-time to healthcare providers, electronic health records (EHR), and clinical laboratories. One that measures the physical condition and emotional state of the user by casting light onto skin, and then records and transmits it with a swipe of the touch screen. Would such an innovation change how patients expect to interact with their providers? And how physicians, anatomic pathologists, and medical laboratories receive data from their patients? Certainly.
This is why US patents recently granted to Apple have caught the attention of industry analysts. Some speculate that the tech giant is planning to enter the mobile healthcare monitoring device, EHR, and healthcare data storage markets, as reported at Becker’s Health IT and CIO Review and Patently Apple.
How this would affect medical laboratories and anatomic pathology groups remains to be seen. But where Apple goes, industries follow. Thus, it’s worth following the company’s activities in the healthcare market.
Bringing Clinical Data, Medical Laboratory Test Results, to iPhone
Mobile devices launched the era of consumer-grade fitness wearables. It’s not uncommon for a smart phone or watch to capture and store a range of health data generated by users. This can include everything from heart rate and sleeping patterns to dietary logs and fertility tracking. But, to date, much of that healthcare data is user generated and does not integrate in any meaningful way with the majority of EHR systems. Nor does it enable communications with primary care providers or diagnostic services—such as medical laboratories or pathology groups.
This may soon change.
According to a CNBC report, a unit at Apple is “in talks with developers, hospitals, and other industry groups about bringing clinical data—such as detailed lab results and allergy lists—to the iPhone, according to a half-dozen people familiar with the team.”
The report states that Apple:
· “Wants the iPhone to become the central bank for health information;
· “Is looking to host clinical information, such as labs and allergy lists, and not just wellness data; and,
· “Is talking with hospitals, researching potential acquisitions, and attending health IT industry meetings.”
Christina Farr, the report’s author, predicts that Apple could be preparing to apply its music industry model to the healthcare industry by, “Replacing CDs and scattered MP3s with a centralized management system in iTunes and the iPod—in the similarly fragmented and complicated landscape for health data.”
Former National Coordinator of Health IT for the Department of Health and Human Services, Farzad Mostashari, MD, ScM, rather enthusiastically noted the significance of the move, stating, “If Apple is serious about this, it would be a big f—ing deal.”
At a special event in September, Apple COO Jeff Williams (above) announced Stanford Medicine’s Apple Heart Study, which uses “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation,” and, according to Williams, “notify users.” This is just one of several healthcare-related study collaborations Apple is exploring. It is not known if Apple is looking to collaborate with medical laboratories. (Photo copyright: Apple.)
Apple’s History with Healthcare Related Technology
Taken as a single event, these speculations might not convince industry leaders. However, Apple’s long-term investments and acquisitions show a clear trend toward integrating healthcare data into the Apple ecosystem.
Healthcare IT News noted that from 2014 to 2017 Apple:
· Unveiled three different APIs—HealthKit, ResearchKit, and CareKit—designed to help capture, analyze, communicate, and integrate healthcare data with the Apple iOS and watchOS ecosystems;
· Hired several MDs, including: Stephen Friend, MD; Rajiv Kumar, MD; Mike Evans, MD; Ricky Bloomfield, MD; and Sumbul Ahmad Desai, MD; and,
· Engaged with the Argonaut Project and Health Gorilla (a centralized hub of healthcare data and information) suggesting a shift from wearables and basic device-based biometrics toward in-depth reporting, interoperability, and access to third-party healthcare data repositories—such as those in a person’s EHR or medical laboratory portal.
The Future of EHRs or Another Failed Attempt at Innovation?
Apple isn’t the only company to attempt such a system. Other efforts include Microsoft’s Health Vault and Google’s now shuttered Google Health. Another CNBC article notes that Amazon is also researching healthcare related options. “The new team is currently looking at opportunities that involve pushing and pulling data from legacy electronic medical record systems,” stated Farr. “The group is also exploring health applications for existing Amazon hardware, including Echo and Dash Wand.”
However, where most services fail to gain traction is user engagement. After all, if a system isn’t widely used or fails to offer benefits over existing systems, patients and service providers are not likely to go through the process of switching systems. Speaking with CNBC, Micky Tripathi, President and CEO of the Massachusetts eHealth Collaborative notes, “At any given time, only about 10% to 15% of patients care about this stuff. If any company can figure out engagement, it’s Apple.”
According to comScore, 85.8-million people over the age of 13 already own an iPhone in the US. The upcoming facial recognition features on Apple’s iPhone X might also provide the added security needed for those questioning the safety of their data. Should Apple succeed, communicating data between clinical laboratories, physicians, and patients might be both convenient and fast. More importantly, it might be the universal platform that finally provides health data access across the entire care continuum, while simultaneously improving access to providers and empowering healthcare consumers.
Of course, this is a few years from reality. But, we can speculate … would innovative medical laboratories have their patients’ lab test data hosted in the Cloud in such a way that patients and providers could access it securely, along with other protected clinical records?
Imagine how this would enable patients to have their complete medical record traveling with them at all times.
—Jon Stone
Related Information:
Could Apple Be Taking a Bite Out of EHRs?
Could Amazon or Apple Actually Make a Dent In the EHR Market?
Apple Extends Its Reach into Healthcare
Electronic device that computes health data
Apple Is Quietly Working on Turning Your iPhone Into the One-Stop Shop for All Your Medical Info
Wait! What? Amazon and Apple Eye Building EHRs
Apple Is Working with This Small Start-Up to Change How We Track Our Health
Timeline: How Apple Is Piecing Together Its Secret Healthcare Plan
Amazon Has a Secret Health Tech Team Called 1492 Working on Medical Records, Virtual Doc Visits
With Apple Consulting Argonaut Project on Health Records, Interoperability Could Get the Push It Needs
Apple Enlists Help of Startup Health Gorilla to Add Diagnostic Data to iPhones
Nov 20, 2017 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
FDA is streamlining how new diagnostic tests are approved; encourages IVD companies to focus on ‘qualifying biomarkers’ in development of new cancer drugs
It is good news for the anatomic pathology profession that new insights into the human immune system are triggering not only a wave of new therapeutic drugs, but also the need for companion diagnostic tests that help physicians decide when it is appropriate to prescribe immunotherapy drugs.
Rapid advances in precision medicine, and the discovery that a patient’s own immune system can be used to suppress chronic disease, have motivated pharmaceutical companies to pursue new research into creating targeted therapies for cancer patients. These therapies are based on a patient’s physiological condition at the time of diagnosis. This is the very definition of precision medicine and it is changing how oncologists, anatomic pathologists, and medical laboratories diagnose and treat cancer and other chronic diseases.
Since immunotherapy drugs require companion diagnostic tests, in vitro diagnostic (IVD) developers and clinical laboratory and pathology group leaders understand the stake they have in pharma companies devoting more research to developing these types of drugs.
New cancer drugs combined with targeted therapies would directly impact the future of anatomic pathology and medical laboratory testing.
Targeted Therapies Cost Less, Work Better
Targeted therapies focus on the mechanisms driving the cancer, rather than on destroying the cancer itself. They are designed to treat cancers that have specific genetic signatures.
One such example of a targeted therapy is pembrolizumab (brand name: Keytruda), a humanized antibody that targets the programmed cell death 1 (PD-1) receptor. The injection drug was primarily designed to treat melanoma. However, the FDA recently expanded its approval of Keytruda to include treatment of tumors with certain genetic qualities, regardless of the tumor’s location in the body. It was the first time the FDA has expanded an existing approval.
In a Forbes article, David Shaywitz, MD, PhD, noted that pembrolizumab had “an unprecedented type of FDA approval … authorizing its use in a wide range of cancers.” Shaywitz is Chief Medical Officer of DNAnexus in Mountain View, Calif.; Visiting Scientist, Department of Biomedical Informatics at Harvard Medical School; and Adjunct Scholar, American Enterprise Institute.
Cancers with high mutational burdens respond to the therapy because they are more likely to have what Shaywitz calls “recognizable novel antigens called mutation-associated neoantigens, or MANAs.” Such cancers include melanomas, non-small cell lung cancer, some rare forms of colorectal cancers, and others.
Such therapies require genetic sequencing, and because sequencing is becoming faster and less expensive—as is the analysis of the sequencing—the information necessary to develop targeted therapies is becoming more accessible, which is part of what’s motivating pharma research.
Biomarkers and Traditional versus Modern Drug Testing and Development
At the same time pharma is developing new immunotherapies, the FDA is recognizing the benefit of faster approvals. In an FDA Voice blog post, Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) at the FDA, wrote, “In the past three years alone, [we have] approved more than 25 new drugs that benefit patients with specific genetic characteristics … and we have approved many more new uses—also based on specific genetic characteristics—for drugs already on the market.”
In his Forbes article, Shaywitz notes that pembrolizumab’s development foreshadows a “More general trend in the industry,” where the traditional phases of drug testing and development in oncology are becoming less clear and distinct.
Along with the changes to drug development and approval that precision medicine is bringing about, there are also likely to be changes in how cancer patients are tested. For one thing, biomarkers are critical for precision medicine.
However, pharmaceutical companies have not always favored using biomarkers. According to Shaywitz, “In general, commercial teams tend not to favor biomarkers and seek to avoid them wherever possible.” And that, “All things being equal, a doctor would prefer to prescribe a drug immediately, without waiting for a test to be ordered and the results received and interpreted.”
In July, just weeks after expanding its approval for Keytruda, the FDA approved a Thermo Fisher Scientific test called the Oncomine Dx Target Test. A Wired article describes it as “the first next-generation-sequencing-based test” and notes that it “takes a tiny amount of tumor tissue and reports on alterations to 23 different genes.”
Thermo Fisher’s Oncomine DX Target Test (above) is the first multi-drug next-generation sequencing test approved by the FDA. The test is a companion diagnostic for lung-cancer drugs made by Novartis and Pfizer. (Caption and photo copyright: Thermo Fisher Scientific.)
Unlike pembrolizumab, however, the Oncomine Dx Target Test did not enjoy fast-track approval. As Wired reported, “Getting the FDA’s approval took nearly two years and 220,000 pages of data,” in large part because it was the first test to include multiple genes and multiple drugs. Thus, according to Joydeep Goswami, PhD, President of Clinical Next Generation Sequencing at Thermo Fisher, “That put the technology under extraordinary scrutiny.”
FDA Encouraging Use of Biomarkers in Precision Medicine Therapies
The FDA, however, is taking steps to make that process easier. Woodcock noted in her FDA Voice blog post that the agency is actively encouraging drug developers to “use strategies based on biomarkers.” She added that the FDA currently “works with stakeholders and scientific consortia in qualifying biomarkers that can be used in the development of many drugs.”
Additionally, in a column he penned for Wired, Robert M. Califf, MD, former Commissioner of the FDA, states that the organization has “begun to lay out a flexible roadmap for regulatory approval.” He notes, “Given the complexity of NGS [next-generation-sequencing] technology, test developers need assurance as well, and we’ve tried to reduce uncertainty in the process.”
Regulations that assist IVD developers create viable diagnostics, while ensuring the tests are accurate and valid, will be nearly as important in the age of precision medicine as the therapies themselves.
All of these developmental and regulatory changes will impact the work done by pathologists and medical laboratories. And since precision medicine means finding the right drug for the individual patient, then monitoring its progress, all of the necessary tests will be conducted by clinical laboratories.
Faster approvals for these new drugs and tests will likely mean steep learning curves for pathologists. But if the streamlined regulation process being considered by the FDA works, new immunoassay tests and targeted therapies could mean improved outcomes for cancer patients.
—Dava Stewart
Related Information:
How Precision Medicine, Immunotherapy Are Influencing Clinical Trial Design for Cancer Drugs
Pharma Cooperates to Achieve Precision Medicine
The Startling History Behind Merck’s New Cancer Blockbuster
Two Recent Scientific Advances Underscore an Encouraging Future for Precision Medicine at FDA
Fast, Precise Cancer Care Is Coming to a Hospital Near You
Biomarker Trends Are Auspicious for Pathologists and Clinical Laboratories
Precision Healthcare Milestone Reached as Food and Drug Administration Clears New Multi-Marker Medical Laboratory Test to Detect Antibiotic-Resistant Bacteria
Genetic Tests and Precision Medicine Start to Win Acceptance by Some Payers; Pathologists and Clinical Laboratories Have Opportunity as Advisors
Nov 17, 2017 | Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Ongoing research at the University of Washington promises new methods for identifying and cataloging large numbers of cells quickly, which could lead to more individualized treatments in support of precision medicine initiatives
Researchers have found a new method for identifying specific cell types by groups, a breakthrough that some experts say could lead to new and more accurate methods for diagnosing and treating disease in individual patients, and new tools for fighting cancer and other chronic diseases. If this happens, both clinical laboratories and anatomic pathology labs would benefit from this technology.
A study published in the journal Science titled, “Comprehensive Single-Cell Transcriptional Profiling of a Multicellular Organism,” describes advances in cataloging cells that are much faster than the traditional method of using a microscope. The research is still in the experimental stage, but it is being hailed as both exciting and promising by experts in the field.
Barcoding Large Numbers of Cells for Viewing Simultaneously
To test their method, researchers from the University of Washington (UW) sequenced each cell of an individual Caenorhabditis elegans (nematode). Nematodes are transparent roundworms that have been extensively studied making them ideal for the UW study, since much information exists about their cellular structure.
The researchers developed a strategy they dubbed “single-cell combinatorial indexing RNA sequencing,” or “sci-RNA-seq” for short, to profile the transcriptomes of nuclei. A New York Times article on the study describes sci-RNA-seq as a kind of barcoding that shows which genes are active in each cell.
“We came up with this scheme that allows us to look at very large numbers of cells at the same time, without ever isolating a single cell,” noted Jay Shendure, PhD, MD, Professor of Genome Sciences at the University of Washington.
The UW researchers used sci-RNA-seq to measure the activity in 42,035 cells at the same time. Once all of the cells were tagged, or barcoded, the researchers broke them open so the sequences of tags could be read simultaneously.
“We defined consensus expression profiles for 27 cell types and recovered rare neuronal cell types corresponding to as few as one or two cells,” wrote the researchers in their published study.
Because such a rich body of research on nematodes exists, the researchers could easily compare the results that got to those procured in previous studies.
Jay Shendure, MD, PhD (above), Professor of Genomic Sciences at the University of Washington, and an Investigator at the Howard Hughes Medical Institute, was just a graduate student when his work with genetics led to the development of today’s next-generation gene sequencing technologies. His new cell-type identification technology could eventually be used by clinical laboratories and anatomic pathology groups to diagnose disease. (Photo copyright: Howard Hughes Medical Institute.)
One Giant Leap for Medical Diagnostics
Identifying cell types has been a challenge to the medical community for at least 150 years. It is important for scientists to understand the most basic unity of life, but it has only been in the last few years that researchers have been able to measure transcriptomes in single cells. Even though the research so far is preliminary, the scientific community is excited about the results because—should the methods be refined—it could mean a great leap forward in the field of cell-typing.
However, the study did not identify all of the cell types known to exist in a nematode. “We don’t consider this a finished project,” stated Shendure in a New York Times article.
Nevertheless, researchers not associated with the study feel confident about the promise of the work. Cori Bargmann, PhD, a neurobiologist and Torsten N. Wiesel Professor at The Rockefeller University, and an Investigator for the Howard Hughes Medical Institute from 1995 to 2016, states that the results “will be valuable for me and for the whole field,” adding, “Of course, there’s more to do, but I am pretty optimistic that this can be solved.”
“The ability to measure the transcriptomes of single cells has only been feasible for a few years, and is becoming an extremely popular assay,” wrote Valentine Svensson, predoctoral fellow et al, of EMBL-EBI in the UK, in a paper titled, “Exponential Scaling of Single-Cell RNA-Seq in the Last Decade.” He added, “Technological developments and protocol improvements have fueled a consistent exponential increase in the numbers of cells studied in single cell RNA-seq analyses.” The UW research represents another such improvement.
Human Cell Atlas—Understanding the Basis of Life Itself
There are approximately 37-trillion cells in the human body and scientists have long believed there are 200 different cell types. Thus, there is an enormous difference between a nematode and a human body. For medical science to benefit from these studies, massive numbers of human cells must be identified and understood. Efforts are now underway to catalog and map them all.
The Human Cell Atlas (HCA) is an effort to catalog all of those disparate cell types. The mission of HCA is “To create comprehensive reference maps of all human cells—the fundamental units of life—as a basis for both understanding human health and diagnosing, monitoring, and treating disease.”
According to HCA’s website, having the atlas completed will impact our understanding of every aspect of human biology, from immunologic diseases to cancer. Aviv Regev, PhD, of the Broad Institute at MIT, who also is an Investigator with the HHMI and is co-chair of the organizing committee at the Human Cell Atlas notes, “The human cell atlas initiative will work through organs, tissues, and systems.”
One of the many complications of creating the atlas is that the locations of cells vary in humans. “The trick,” Regev noted in the New York Times article, “is to relate cells to the place they came from.” This would seem to be at the heart of the UW researchers’ new method for “barcoding” groups of cells.
Just as sequencing the entire human genome has brought about previously unimagined advances in science, so too will the research being conducted at the University of Washington, as well as the completion of the Human Cell Atlas Project. It is possible that pursuing the goal of quickly identifying and cataloging cells will lead to advances in anatomic pathology, and allow medical laboratory scientists to better interpret genetic variants, ultimately bringing healthcare closer to the delivery of true precision medicine.
—Dava Stewart
Related Information:
Comprehensive Single-Cell Transcriptional Profiling of a Multicellular Organism
A Speedier Way to Catalog Human Cells (All 37 Trillion of Them)
Exponential Scaling of Single-Cell RNA-Seq In the Last Decade
Human Cell Atlas
Genetic Fingerprint Helps Researchers Identify Aggressive Prostate Cancer from Non-Aggressive Types and Determine if Treatment Will Be Effective
Big Data Projects at Geisinger Health Are Beginning to Help Physicians Speed Up Diagnosis and Improve Patient Care
Biomarker Trends Are Auspicious for Pathologists and Clinical Laboratories
Pathologists and Clinical Laboratories May Soon Have a Test for Identifying Cardiac Patients at Risk from Specific Heart Drugs by Studying the Patients’ Own Heart Cells
Nov 15, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
Onboard cooling system ensures samples remain viable for medical laboratory analysis after three-hour flight across Arizona desert
Clinical laboratories and anatomic pathology groups could soon be receiving blood samples and tissue specimens through the air by medical drone. The technology has been tested successfully in Europe, which Dark Daily reported in July. Now, Johns Hopkins University Medicine (JHUM) has set a record in America for the longest distance drone delivery of viable medical specimens.
In a project to demonstrate the viability of using drones to transport medical laboratory specimens, the Johns Hopkins University team flew a drone with specimens more than 161 miles across the Arizona desert. The goal is to bring autonomous medical delivery drones a step closer to transforming how specimens get transported across long distances, according to a Johns Hopkins press release.
A previous Johns Hopkins study in 2015 proved common and routine blood tests were not affected when medical laboratory specimens were transported in up to 40-minute flights on hobby-sized drones. This latest research provides evidence that unmanned aircraft may be able to successfully and quickly shuttle medical specimens even longer distances between remote hospitals and medical laboratories.
Transporting Clinical Laboratory Samples by Air Can Save Lives
In conducting its most recent study, Johns Hopkins researchers obtained paired chemistry and hematology samples from 21 adults (84 samples in total). One sample from each pair was held at a drone test range in a car with active cooling. Remaining samples were flown for three hours in a drone with a Johns Hopkins-designed onboard payload-cooling system to maintain temperature control in the hot desert environment.
A temperature-controlled specimen transport container (above) designed by the Johns Hopkins University research team ensured the blood samples remained cooled and were viable for testing after the three-hour drone flight in the Arizona heat. The project demonstrated the viability of using drones to transport medical laboratory specimens. (Photo copyright: Johns Hopkins Medicine.)
After the 161-mile flight, all samples were transported 62 miles by car to the Mayo Clinic in Scottsdale, Ariz., for testing. Flown and not-flown paired samples showed similar results for red blood cell, white blood cell and platelet counts, and sodium levels, among other results. Only glucose and potassium levels revealed minor but statistically significant differences in results.
Pathologist Timothy Amukele, MD, PhD (above), led a team of researchers at Johns Hopkins University School of Medicine that set a new distance delivery record for medical drones after successfully transporting human blood samples 161 miles across the Arizona desert. The test flight adds to the growing evidence that unmanned aircraft may be the most effective way to quickly transport blood and other medical samples to clinical laboratories. (Photo copyright: Johns Hopkins Medicine.)
In a report of the findings published in the American Journal of Clinical Pathology (AJCP), the research team concludes that long drone flights at high temperature “do not appear to affect the accuracy of 17 of the 19 test types in this study.” However, they note, “Time- and temperature-sensitive analytes such as glucose and potassium will require good pre-planning and stringent environmental controls to ensure reliable results.”
The John Hopkins team believes their achievement adds to mounting evidence that drone transportation can transform the delivery of clinical laboratory specimens.
“We expect that in many cases, drone transport will be the quickest, safest, and most efficient option to deliver some biological samples to a laboratory from rural or urban settings,” stated Timothy Kien Amukele, MD, PhD, Assistant Professor of Pathology at Johns Hopkins University School of Medicine and the paper’s senior author, in a Johns Hopkins Magazine article.
“Getting diagnostic results far more quickly under difficult conditions will almost certainly improve care and save more lives,” Amukele added.
Full Drone Delivery Network Operating Over Switzerland
Medical drones are rapidly moving from demonstration projects to active use. As Dark Daily previously reported, Switzerland is establishing a delivery network of medical drones in the city of Lugano. In March 2017, drone logistics system developer Matternet, based in Menlo Park, Calif., received authorization from the Swiss Federal Office for Civil Aviation (FOCO) for full operation of drone logistics networks over densely populated areas in Switzerland. Working in partnership with Swiss Post (Switzerland’s postal service) and the Ticino EOC hospital group, Matternet successfully completed roughly 100 drone transport test flights between two of Ticino EOC’s hospitals in Lugano.
Another major player in medical drone delivery is Zipline, a Silicon Valley-based drone delivery company that since October 2016 has flown more than 14,000 flights in Rwanda, delivering 2,600 units of blood. The company’s foothold in Africa expanded in August when Tanzania announced it was partnering with Zipline to launch the “world’s largest drone delivery service to provide emergency on-demand access to critical and life-saving medicines.” Tanzania will establish four distribution centers that will use more than 100 drones to make up to 2,000 flights a day.
The emergence of medical drones not only could speed up diagnoses for patients in remote regions of the world and rural communities, but also could revolutionize anatomic pathology specimen deliveries to clinical laboratories in urban areas by providing a faster, more reliable and lower-cost delivery option than third-party couriers using ground transportation.
—Andrea Downing Peck
Related Information:
Study Sets New Distance Record for Medical Drone Transport
Drone Transport of Chemistry and Hematology Samples Over Long Distances
Using Drones to Transport Blood Samples Could Speed Diagnosis, Treatment
Drone Carrying Blood Samples Travels 160 Miles in Arizona Desert to Set New Record
Matternet Unveils the Matternet Station
Tanzania Announces World’s Largest National Drone Delivery Network Partnering with Zipline
Drones Used to Deliver Clinical Laboratory Specimens in Switzerland
Nov 8, 2017 | Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Increased use of telemedicine may create opportunities for clinical laboratories to deliver increased value to both physicians and nurses
Recent data shows widespread employer adoption of telehealth services may soon become a reality. However, studies also show virtual provider visits and other telemedicine technologies are unlikely to diminish the role of clinical laboratories in providing the data required for diagnosis and treatment decisions. Instead, laboratories and anatomic pathology groups will likely see changes in how samples are collected from patients using telemedicine and how medical laboratory test results are reported, as access to telemedicine grows.
A recent National Business Group on Health (NBGH) survey indicates that in 2018 “virtually all [large] employers (96%) will make telehealth services available in states where it is allowed.” The survey was conducted between May and June 2017, with 148 large employers participating.
Christine Smalley, Managing Director with consulting firm Claremont Hudson, divides telemedicine technology into three distinct segments:
1. Provider-to-provider;
2. Remote patient monitoring; and,
3. Patient-to-provider.
In an article she penned for MedCityNews, Smalley calls provider-to-provider telemedicine the “most evolved to-date” segment of the telehealth trend. She highlights ICU stroke care with remote consults and monitoring as an example of its “success,” and notes a large potential for growth in remote patient monitoring (RPM). Smalley cites a Berg Insight report that estimates 50-million patients will use remote monitored devices by 2021. However, Smalley also notes consumer acceptance of patient-to-provider telemedicine has fallen short of industry expectations.
While virtual office visits—where patients have access to physicians via telephone or videoconferencing—grab headlines, Smalley argues that “several factors” are hindering adoption.
“Reimbursement is not yet universal,” she notes. “But consumers are growing used to paying more out-of-pocket with high-deductible plans. Physicians have long resisted change in how they practice, and many remain lukewarm at best about telemedicine. It’s no coincidence that many of the innovations and pioneering models have come from outside of healthcare delivery … The barriers that loom the largest may likely be consumer awareness and trial.”
The Center for Connected Health Policy (CCHP) reports that 35 states have laws governing private payer reimbursement of telehealth, a number that has not changed since 2016. According to a CCHP press release, some state laws require reimbursement be equal to in-person visits, though not all laws mandate reimbursement.
Adopting Existing Retail Models to Promote Telemedicine to Patients
Smalley contends “smart marketing” will be needed to get consumers to leverage the telemedicine options that are becoming available to them. She says simply offering video or telephone visits is not enough. She encourages integrated delivery systems to take a page out of retailers’ playbooks.
“Look at how retailers, like Walmart, integrate online shopping and the store experience by offering side-by-side options supporting product delivery and in-store pickup. Telemedicine options ultimately need to be offered in a way that feels integrated and seamless to the health consumer,” she suggested, in her MedCityNews article. One example, she notes, would be providing an easy-to-navigate link to a virtual visit on a healthcare network’s urgent care webpage.
Click image above to see YouTube video
Healthcare Spending Could Increase Due to Telehealth
While health plans have zeroed in on telehealth as a way to drive down healthcare costs, a 2017 RAND Corp. study published in Health Affairs found virtual visits to physicians might not decrease spending, though access to care is improved.
“Instead of saving money by substitution [replacing more expensive visits to physician offices or EDs], direct-to-consumer telehealth may increase spending by new utilization [increasing the total number of patient visits],” a MedCityNews article suggests.
The RAND study examined commercial claims data of workers enrolled in the California Public Employees’ Retirement System (CalPERS) Blue Shield of California HMO (Health Maintenance Organization) from 2011-2013. Researchers focused on care received for acute respiratory infections. According to a RAND press release, net annual spending for acute respiratory infections increased by $45 per telehealth user.
“Given that direct-to-consumer telehealth is even more convenient than traveling to retail clinics, it may not be surprising that an even greater share of telehealth services represents new medical use,” noted Lori Uscher-Pines, PhD, a RAND Policy Researcher. “There may be a dose response with respect to convenience and use: the more convenient the location, the lower the threshold for seeking care and the greater the use of medical services.”
Telehealth in Clinical Laboratories
Will telehealth services offered by hospital networks and healthcare providers impact clinical laboratories? While a physical visit is still required for drawing blood, collecting urine, or performing pathology testing, interpretive digital pathology, such as Whole Slide Imaging (AKA, Virtual Slide), does enable pathologists to provided distance interpretation services of blood tests to remote and/or resource deficient areas of the world, as Dark Daily reported in past e-briefings. This could become a substantial revenue stream in the future if telepathology’s global popularity continues to rise.
—Andrea Downing Peck
Related Information:
Telemedicine Is on the Rise, Including for Labs
Large U.S. Employers Project Health Care Benefit Costs to Surpass $14,000 per Employee in 2018, National Business Group on Health Survey Finds
Large Employers’ 2018 Health Care Strategy and Plan Design Survey
Take a Lesson from Retail to Improve Patient Adoption
mHealth and Home Monitoring
Direct-to-Consumer Telehealth Prompts New Use of Medical Services; Not Likely to Decrease Health Spending
State Telehealth Laws and Reimbursement Policies, April 2017
CCHP Releases Fifth Edition of 50 State Telehealth Lawns and Reimbursement Policies Report
Almost All Large Employers Plan to Offer Telehealth in 2018, but Will Employees Use It?
Direct-to-Consumer Telehealth May Increase Access to Care but Does Not Decrease Spending
International Telemedicine Gains Momentum, Opening New Markets for Pathologists and Other Specialists
‘Nighthawk’ Radiology Services Expand to Hospital Pharmacies: Could Pathology Laboratories Be Next?
From Micro-hospitals to Mobile ERs: New Models of Healthcare Create Challenges and Opportunities for Pathologists and Medical Laboratories
Nov 3, 2017 | Laboratory News, Laboratory Operations, Laboratory Pathology
Medical laboratory leaders urged to scrutinize pricing policies, billing decisions, and structural relationships that could trigger commercial payer and regulatory action
Clinical laboratories and pathology groups face another blow to their financial health on January 1, 2018, when new Medicare Part B price cuts take effect. Faced with increasing competition and declining reimbursement rates for anatomic pathology testing, medical laboratories will begin 2018 with their profitability under threat. In addition, healthcare legal experts warn many medical laboratory leaders risk further financial hardships by establishing “problematic” business relationships or developing pricing plans that put their labs at “unreasonable risk” with commercial payers and government regulators.
Financial Pressures Lead Clinical Laboratories to Risky Deals and Policies
One such expert is, attorney Jeffrey J. Sherrin, President and Partner at O’Connell and Aronowitz in Albany, New York. He contends that financial pressures are the impetus for many laboratories’ questionable deal-making and pricing policies.
“We’re increasingly dealing with proposed structures that clinical labs are entering into or considering entering into to remain viable, but without properly assessing how those relationships may run afoul of federal or state law or provider agreements,” Sherrin noted in an interview with Dark Daily. “If that doesn’t keep the labs up at night, it keeps us up at night!”
Tougher Auditing and Billing Scrutiny
While the “overwhelming majority of lab directors, owners, and managers are honest and law abiding,” Sherrin maintains they are “stepping into a minefield” by failing to properly vet decisions regarding:
1. Lab billing and referral arrangements that could violate federal and state anti-kickback or fee-splitting laws, or trigger violations of provider agreements with health insurers.
2. Participation in healthcare Management Service Organizations (MSOs) that involve “billing schemes” rather than legitimate administrative services, marketing, or data-collection activities.
3. Pricing plans and billing policies that could trigger increased scrutiny by government and commercial payers over balance-billing of patients, and waiver or partial waiver of co-pays and deductibles.
In an era of shrinking reimbursements and limited access to healthcare networks, Sherrin urges medical laboratory leaders to be aware of another new reality: tougher audits from commercial payers whose investigators “perceive that there is rampant fraud in the industry” that extends beyond toxicology/pharmacogenomics or molecular/genetic testing laboratories.
“In payers’ minds, it’s across the board,” Sherrin says. “When they see patterns of limiting or capping or waiving of patient responsibility, their normal inclination is to assume this is part and parcel of some fraudulent scheme or practice, as opposed to a proper business decision.”
Proactive Steps to Improve Medical Lab Leader Decision-Making
Seeking guidance from a healthcare attorney before establishing new business relationships, and pricing or billing policies, is one way to increase your laboratory’s odds of surviving payer action.
“Most labs adopt a pricing policy without fully vetting whether they are doing it the right way, the best way, or the way that creates as little risk as possible,” Sherrin notes. “A high percentage of labs have not approached this issue with a degree of scrutiny as to whether the marketing of their test menu, their prices, and how they bill puts them in a better or worse position. Most are making business decisions based on what they need to do competitively without having the ramifications and implications analyzed.”
To help medical laboratory and pathology group leaders prepare for the perils they face, Dark Daily’s upcoming webinar, “Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More,” will reveal how lab leaders can take proactive steps to navigate the tough lab regulations and legal issues that lay ahead.
To attend this critical educational opportunity, click here to register (or place this link into your browser: https://ddaily.wpengine.com/product/tougher-lab-regulations-and-new-legal-issues-in-2018-more-frequent-payer-audits-problems-with-contract-sales-reps-increased-liability-for-clia-lab-directors-proficiency-testing-violations-and).
Healthcare attorney Jeffrey W. Sherrin, President and Partner, O’Connell and Aronowitz, will be one of three featured speakers during a new Dark Daily webinar on the upcoming Medicare Part B price cuts, and the critical legal and compliance issues facing clinical laboratories and pathology groups in 2018. (Photo copyright: O’Connell and Aronowitz.)
This crucial learning event takes place on Wednesday, November 8, 2017, at 1 p.m. EST. Sherrin will be joined by David W. Gee, JD, Partner at Davis Wright Tremaine LLP in Seattle, Wash., and Richard Cooper, JD, Chair of the National Healthcare Practice Group, McDonald Hopkins LLC, in Cleveland.
These three attorneys are among the nation’s foremost experts in issues unique to clinical laboratories, pathology groups, hospital labs, toxicology/pharmacogenomics labs, and molecular/genetic testing labs. Following our speakers’ presentations, there will be a question and answer period, during which you can submit your own specific questions to our experts.
You can’t afford to miss this opportunity. Click here to get up to speed on the most serious regulatory, compliance, and managed care contracting issues confronting all clinical laboratories today. This webinar will provide solutions to the perils facing labs now and in 2018 by helping you map a proactive and effective course of action for your clinical lab or pathology group.
—Andrea Downing Peck
Related Information:
Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More
What Every Lab Needs to Know about the Medicare Part B Clinical Laboratory Price Cuts That Take Effect in Just 157 Days, on Jan. 1, 2018
Nation’s Most Vulnerable Clinical Laboratories Fear Financial Failure If Medicare Officials Cut Part B Lab Fees Using PAMA Market Price Data Final Rule
