As federal regulatory agencies continue to push transparency, hospitals, medical labs, anatomic pathology groups, and other healthcare providers must develop strategies for remaining competitive and maintaining patient volume
More price transparency continues to be a goal of Medicare officials. Some clinical laboratory managers and pathologists may be unaware of a proposed rule issued by the federal Centers for Medicare and Medicaid Services (CMS) in April that would require hospitals to post prices online as early as this January 1, 2019.
This action is a definitive demonstration of how the federal healthcare program continues to scrutinize how healthcare organizations communicate with patients and post their prices. This pressure on healthcare systems and individual providers extends to the clinical laboratories and anatomic pathology groups that support them. Without a plan to address these changes, medical laboratory test volume and practice revenues can be severely impacted.
Recent coverage from RevCycleIntelligence indicates that this trend is only just getting started.
“When you go to receive a healthcare service, there are always going to be situations where you can’t know what the costs will be, especially around emergency situations and some acute situations,” Centers for Medicare and Medicaid (CMS) Administrator Seema Verma told RevCycleIntelligence. “But for a lot of us, we’re going in for planned procedures. You should be able to know what it’s going to cost you.”
In April 2018, CMS posted a proposed rule that requires hospitals to post standard service rates online and update their pricing lists at least annually starting January 1, 2019. While many healthcare organizations currently report pricing to state boards and other online directories, this rule, if enacted, could make it easier for consumers to source reliable pricing information before obtaining care.
“We are concerned that challenges continue to exist for patients due to insufficient price transparency. Such challenges include patients being surprised by out-of-network bills for physicians—such as anesthesiologists and radiologists who provide services at in-network hospitals—and patients being surprised by facility fees and physician fees for emergency room visits. We also are concerned that chargemaster data are not helpful to patients for determining what they are likely to pay for a particular service or hospital stay,” the CMS proposed rule states.
In the proposed rule that references out-of-network bills, pathologists should have been included as a hospital-based physician service—such as anesthesiologists and radiologists—that submits bills to patients for care provided in the hospital. Pathology practice administrators may want to review the specific language of the proposed rule to understand how hospitals served by the pathology group will be required to post prices.
“If you’re buying a car or pretty much anything else, you’re able to do some research,” Seema Verma (above), Administrator, Centers for Medicare and Medicaid Services told RevCycleIntelligence. “You’re able to know what the quality is. You’re able to make comparisons. Why shouldn’t we be able to do that in healthcare? Every healthcare consumer wants that.” (Photo copyright: Centers for Medicare and Medicaid Services.)
Transparency Concerns Lead to Additional Questions from CMS
Alongside the proposed rule, CMS also is issuing a request for information (RFI) to give healthcare experts an opportunity to:
Demonstrate the impact of current proposals; and,
Make recommendations to further align the proposal with both the needs of healthcare organizations and service providers as well as the cost-reduction goals of CMS.
Key questions, according to RevCycleIntelligence, include:
How should “standard charges” be defined (e.g., average or median rates for chargemaster items; average or median rates for groups of services commonly billed together as determined by the hospital; or average discount off the chargemaster amount across all payers)?
What types of information would help patients understand hospital prices and patient financial responsibility? How should hospitals use this information to inform patients and decision-making?
Should healthcare providers be required to tell patients about their out-of-pocket costs for a service prior to care delivery? Should providers even play a role in informing patients of out-of-pocket costs?
Should CMS require providers to give patients information on what Medicare pays for a service?
How should CMS enforce healthcare price transparency requirements? Should hospitals have to attest to meeting requirements?
Implications for Healthcare Services and Diagnostics Providers
RevCycleIntelligence reports that between CMS rules and bills introduced by Senators, an increase in healthcare transparency pricing is likely. These requirements will continue to apply pressure to clinical laboratories, anatomic pathology groups, and other diagnostics providers.
Much like the importance of communicating value to the new wave of payer and physician partnerships emerging around the country, transparency will offer an opportunity to communicate value to consumers.
However—particularly for high-margin services and assays—laboratories must create strategies to address pricing transparency and communicate the value of their services if they hope to maintain volumes and financial integrity at existing levels.
A study conducted by Johns Hopkins University researchers and published in The American Surgeon also highlights benefits that transparency might hold outside of simple regulatory compliance.
Analyzing data from six ambulatory care centers from 2016, they found that five out of six reported increases in both patient volume and revenue after adopting price transparency. Half of the centers also reported a reduction in administrative burden—a concern that medical laboratories must also address as streamlining operations and optimizing efficiency becomes a core part of successful lab operation in the face of healthcare reform.
Clinical laboratories and anatomic pathology groups should develop a strategy for addressing new transparency requirements. That strategy should include ways to effectively communicate their value to both healthcare providers and consumers. Should the CMS proposed rule progress to a final rule, failure to address pricing transparency may result in enforcement and compliance concerns—a critical issue for laboratories already facing tighter markets and increased regulatory and payer scrutiny.
Researchers in Boston are working to develop DNA as a low-cost, effective way to store data; could lead to new molecular technology industries outside of healthcare
Even as new insights about the role of DNA in various human diseases and health conditions continue to tumble out of research labs, a potential new use for DNA is emerging. A research team in Boston is exploring how to use DNA as a low-cost, reliable way to store and retrieve data.
This has implications for the nation’s clinical laboratories and anatomic pathology groups, because they are gaining experience in sequencing DNA, then storing that data for analysis and use in clinical care settings. If a way to use DNA as a data storage methodology was to become reality, it can be expected that medical laboratories will have the skillsets, experience, and information technology infrastructure already in place to offer a DNA-based data storage service. This would be particularly true for patient data and healthcare data.
Finding a way to reduce the cost of data storage is a primary reason why scientists are looking at ways that DNA could be used as a data storage technology. These scientists and technology developers seek ways to alleviate the world’s over-crowded hard drives, cloud servers, and databases. They hope this can be done by developing technologies that store digital information in artificially-made versions of DNA molecules.
The research so far suggests DNA data storage could be used to store data more effectively than existing data storage solutions. If this proves true, DNA-based data storage technologies could play a key role in industries outside of healthcare.
If so, practical knowledge of DNA handling and storage would be critical to these companies’ success. In turn, this could present unique opportunities for medical laboratory professionals.
DNA Data Storage: Durable but Costly
Besides enormous capacity, DNA-based data storage technology offers durability and long shelf life in a compact footprint, compared to other data storage mediums.
“DNA has an information-storage density several orders of magnitude higher than any other known storage technology,” Victor Zhirnov, PhD, Chief Scientist and Director, Semiconductor Research Corporation, told Wired.
However, projected costs are quite high, due to the cost of writing the information into the DNA. However, Catalog Technologies Inc. of Boston thinks it has a solution.
Rather than producing billions of unique bits of DNA, as Microsoft did while developing its own DNA data storage solution, Catalog’s approach is to “cheaply generate large quantities of just a few different DNA molecules, none longer than 30 base pairs. Then [use] billions of enzymatic reactions to encode information into the recombination patterns of those prefab bits of DNA. Instead of mapping one bit to one base pair, bits are arranged in multidimensional matrices, and sets of molecules represent their locations in each matrix.”
The Boston-based company plans to launch an industrial-scale DNA data storage service using a machine that can daily write a terabyte of data by leveraging 500-trillion DNA molecules, according to Wired. Potential customers include the entertainment industry, federal government, and information technology developers.
Catalog is supported by $9 million from investors. However, it is not the only company working on this. Microsoft and other companies are reportedly working on DNA storage projects as well.
“It’s a new generation of information storage technology that’s got a million times the information density, compared to flash storage. You can shrink down entire data centers into shoeboxes of DNA,” Catalog’s CEO, Hyunjun Park, PhD (above center, between Chief Science Officer Devin Leake on left and Milena Lazova, scientist, on right), told the Boston Globe. (Photo copyright: Catalog.)
Microsoft, University of Washington’s Synthetic DNA Data Storage
Microsoft and researchers at the University of Washington (UW) made progress on their development of a DNA-based storage system for digital data, according to a news release. What makes their work unique, they say, is the large-scale storage of synthetic DNA (200 megabytes) along with the ability to the retrieve data as needed.
“Synthetic DNA is durable and can encode digital data with high density, making it an attractive medium for data storage. However, recovering stored data on a large-scale currently requires all the DNA in a pool to be sequenced, even if only a subset of the information needs to be extracted,” the researchers wrote in their paper published in Nature Biotechnology.
“Here, we encode and store 35 distinct files (over 200 megabytes of data ) in more than 13-million DNA oligonucleotides and show that we can recover each file individually and with no errors, using a random access approach,” the researchers explained.
“Our work reduces the effort, both in sequencing capacity and in processing, to completely recover information stored in DNA,” Sergey Yekhanin, PhD, Microsoft Senior Researcher, told Digital Trends.
Successful research by Catalog, Microsoft, and others may soon lead to the launch of marketable DNA data storage services. And medical laboratory professionals who already know the code—the life code that is—will likely find themselves more marketable as well!
As consumers increasingly choose physicians and service providers based on other people’s feedback on review websites, Internet-based customer service programs are becoming critical business tools for clinical laboratories and pathology groups
Clinical laboratory managers are becoming increasingly aware that negative reviews on anonymous online review sites, such as Yelp and others, can negatively impact revenues.
Official sources and surveys, such as Medicare’s Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), already provide information and ratings on healthcare service providers. However, recent coverage in Healthcare Dive highlights how consumers are finding the narrative reviews on websites such as Yelp more accessible and relatable. And, that these reviews focus on the criteria consumers find most important.
“We’re moving to a health system where patient ratings are becoming more important, [one] where top-down ratings are really inaccessible to patients and probably not that useful,” Yevgeniy Feyman, PhD, told Healthcare Dive. Feyman, along with Paul Howard, PhD, co-authored the Manhattan Institute report, “Yelp for Health.”
In the report, they examined the correlation between Yelp reviews of New York hospitals and objective measures of hospital quality. “We find that higher Yelp ratings are correlated with better-quality hospitals and that they provide a useful, clear, and reliable tool for comparing the quality of different facilities as measured by potentially preventable readmission rates (PPR), a widely accepted metric,” they stated.
This is a significant finding for clinical laboratory administrators and pathologists. It demonstrates that how patients review their provider experiences does align with objective measures of provider quality that may be public, but are not as easy for consumers to find as websites like Yelp, Healthgrades, and others.
Online Reviews: A Metric for Determining Healthcare Value and Quality?
Andrea Ducas, Senior Program Manager with the Robert Wood Johnson Foundation (RWJF), told Healthcare Dive the primary considerations patients use to pick providers include:
“Treats patients with respect;
“Accepts insurance;
“Shares in decision-making;
“Responsiveness to phone calls; and,
“Professional skill.”
Research into how patients find/choose their physicians conducted by OnePoll and commissioned by Binary Fountain determined that, of more than 1,000 adults surveyed:
“95% of respondents regard online ratings and reviews as ‘somewhat’ to ‘very’ reliable;
“75% of Americans say online ratings and review sites have influenced their decision when choosing a physician; and,
“30% of consumers share their own healthcare experiences via social media and online ratings and review sites.”
Common research sources listed by respondents included:
“Given that the majority of quality measures out there … aren’t really that accessible for patients, this is a very good proxy,” Feyman told U.S. News in a report on physicians’ concerns about the use and popularity of review sites.
“[T]he emphasis placed on a small number of patient opinions—far fewer patients leave reviews than are treated in a typical health system—makes it harder for doctors to do their job for fear of a career-harming bad review. And a few negative posts from disgruntled patients could unfairly skew public perception—and eventually, a provider’s bottom line,” U.S. News noted.
Despite this, Luther Lowe, Yelp’s Senior Vice President of Public Policy and Government Affairs, assured Healthcare Dive they have processes to “filter spam and quell suspicious activity daily.”
Online reviews recently played an important role in the Wall Street Journal (WSJ) exposé on Theranos, which Dark Daily covered in 2016. Investigative reporter John Carreyrou (above) used Yelp to locate patients who reported negative experiences with specific healthcare services and practices. He described how he used the platform during a presentation to the Association of Health Care Journalists (AHCJ) in April 2018. Click on this link to watch a video of Carreyrou’s presentation. (Photo copyright: Association of Healthcare Journalists.)
Negative Reviews: A Critical Concern for Medical Laboratories
Consumers continue to use Internet platforms to both share ratings and compare information on healthcare professionals and the clinical laboratories supporting them. Thus, to prevent damage from negative reviews, labs must actively monitor feedback, pursue inaccurate information posted online, and encourage consumers to provide positive feedback and opinions.
According to data from Alexa, Yelp is the 32nd most visited website in the United States. Yelp’s own data reports that more than 150-million reviews have been added to the site since its inception 13 years ago.
And, Yelp categorizes 7% of the reviewed businesses as “health-related.”
Between easy-to-access information distributed online and an increased push for transparency, clinical laboratories and other healthcare service providers must work to take charge of the narrative created about their businesses and encourage positive feedback on these developing platforms.
Failing to do so could cost laboratories the physicians’ practices they service.
“There are some providers who are trying to get ahead of the curve and post reviews directly on their website,” Ducas told Healthcare Dive. “Another thing they can do is encourage their patients to read some reviews online and invite them to leave feedback. That’s a radical invitation but it’s certainly something they can do.”
As healthcare customers increasingly turn to review sites for feedback about healthcare facilities and the service providers supporting them, clinical laboratories and anatomic pathology groups must focus on their Internet presence and respond quickly to any negative review feedback with great customer service.
Identifying patients who will likely develop prolonged concussion symptoms could lead to new clinical laboratory tests and personalized medicine treatments
Researchers are homing in on a new diagnostic assay for concussion that could potentially generate significant numbers of test referrals to the nation’s clinical laboratories. This innovative work is targeting how concussions are diagnosed and treated.
Each year, thousands of children receive sports-related injuries, including concussions. There are ways for anatomic pathologists and hospital medical laboratories to diagnose concussions; however, testing can be invasive and doesn’t always reveal a complete picture of the injury state.
Additionally, about one third of children with concussions develop prolonged symptoms. However, when prescribing treatment plans, physicians have been unable to predict which patients are likely to recover quickly versus those who will have a longer recovery.
Now, researchers at Penn State College of Medicine (Penn State) believe they have discovered five microRNAs in saliva that could be used to identify patients who will likely experience prolonged concussion symptoms even one month after the initial injury.
The study also found that certain materials in saliva can help diagnose the severity of concussions and could hold the key to more effective clinical laboratory tests and personalized medicine treatments.
The Penn State researchers published their study results in JAMA Pediatrics, a publication of the Journal of the American Medical Association (JAMA).
Concussion Leading Sports-related Brain Injury
There are approximately 3.8 million sports and recreation-related traumatic brain injuries in the United States each year and the majority of those cases are concussions, according to The Concussion Place. Most concussions treated in emergency rooms are due to falls, motor-vehicle related injuries, being struck by an object, assaults, or playing sports.
Also known as mild traumatic brain injuries (mTBI), concussions are caused by blows or jolts to the head or body that cause the brain to move with excessive force inside the skull. The sudden impact damages brain cells and causes chemical changes within the brain that alter normal functioning. Though usually not life threatening, the damage can be serious and linger for months.
Symptoms of concussion include: headaches, fatigue, nausea, vomiting, dizziness, balance problems, confusion, memory problems, sleep disturbances, and double or blurry vision. Symptoms usually occur immediately, but could take days or even weeks to appear.
Identifying Severity/Predicting Prolonged Symptoms of Traumatic Brain Injuries
After a concussion occurs, brain cells release small fragments of genetic material known as microRNAs while they attempt to repair themselves. A portion of these microRNAs appear in the injured person’s blood and saliva.
In order to determine whether these microRNAs could be used to determine the severity of a traumatic brain injury and predict whether prolonged symptoms would occur, the prospective cohort study researchers gathered saliva samples from 52 concussion patients between the ages of seven and 21:
The average age of the subjects was 14;
Twenty-two of the participants were female;
They were all athletes; and,
The majority of the samples were collected one to two weeks after the initial injury.
The researchers examined distinct microRNAs in the samples and identified some that enabled them to predict how long a patient’s concussion symptoms might last. In addition, they found one microRNA in children and young adults that accurately predicted which subjects would experience memory and problem-solving difficulties as part of their symptomatology.
The researchers also evaluated the concussion patients using the Sport Concussion Assessment Tool (SCAT-3), Third Edition. Physicians use this questionnaire to assess the symptoms and severity of concussions. The researchers also asked the parents of the concussed patients for observations about their children’s symptoms.
During follow up visits, which occurred at four- and eight-week increments following the original assessment, the Penn State researchers collected additional saliva samples and re-evaluated the patients using SCAT-3.
New Biomarkers Based on MicroRNAs Instead of Protein
“There’s been a big push recently to find more objective markers that a concussion has occurred, instead of relying simply on patient surveys,” Steven Hicks, MD, PhD, Assistant Professor of Pediatrics, Penn State College of Medicine, Hershey, Pa., one of the study researchers, told Penn State News.
“Previous research has focused on proteins, but this approach is limited because proteins have a hard time crossing the blood-brain barrier. What’s novel about this study is we looked at microRNAs instead of proteins, and we decided to look in saliva rather than blood,” he noted.
According to Steven Hicks, MD, PhD (above), who worked on the Penn State College of Medicine study, microRNAs could be more accurate than the traditional questionnaire when diagnosing and forecasting the effects of concussions. “The microRNAs were able to predict whether symptoms would last beyond four weeks with about 85% accuracy,” he told Penn State News. “In comparison, using the SCAT-3 report of symptoms alone is about 64% accurate. If you just go off the parent’s report of symptoms, it goes down to the mid-50s. In this pilot study, these molecular signatures are outperforming survey tools.” (Photo copyright: MD Magazine.)
The goal of this research was to develop a way to definitively ascertain that a concussion had occurred, predict the length and type of symptoms, and then use that data to improve and personalize care for children and young adults who have had a concussion.
“With that knowledge physicians could make more informed decisions about how long to hold a child out of sports, whether starting more aggressive medication regimens might be warranted, or whether involving a concussion specialist might be appropriate,” Hicks told MD Magazine. “Anytime we can use accurate, objective measures to guide medical care, I think that represents an opportunity to improve concussion treatment.”
Further research and clinical trials will be needed to solidify the effectiveness and accuracy of these new biomarkers. However, a rapid, non-invasive saliva test that can determine the severity of a concussion, and predicted whether prolonged symptoms will likely occur, would be widely used and could be an important assay for clinical laboratories. Particularly those associated with hospital medical laboratories and emergency rooms.
DOJ says now-defunct clinical laboratory in New Jersey generated test orders by bribing physicians with cash, concert tickets, vacations, high-end automobiles, and prostitutes
It finally happened! Two medical laboratory executives were given jail sentences for their role in the rampant fraud and abuse committed during the operation of Biodiagnostic Laboratory Services (BLS) of Parsippany, N.J. The court accepted their guilty pleas in 2015, but delayed sentencing until this year, because the two defendants cooperated with prosecutors.
Anatomic pathologists and clinical laboratory managers pushing for stronger enforcement of anti-kickback laws may have gotten their wish with the sentences announced by the federal judge. The two BLS executives admitted to bribing doctors in a $100-million kickback scheme. Thirty-eight doctors also have been convicted of criminal felony charges during the more than five-year investigation.
On June 13, the judge sentenced David Nicoll, 44, President of now-defunct BLS, to six years in federal prison. His brother Scott Nicoll, 37, a concert ticket broker who became a senior BLS employee, received a 43-month sentence. Each defendant previously had pled guilty to one count of conspiracy to violate the Anti-Kickback Statute and the Federal Travel Act and one count of money laundering.
“Today, the president of a diagnostic lab company and his brother were sentenced for their leading roles in a scam that led to one of the largest ever prosecutions of medical professionals in a bribery case,” U.S. Attorney Craig Carpenito, JD, stated in a U.S. Attorney’s Office news release. “Medical referrals from a doctor should be based on what’s in the patient’s best interest, not on how much money the doctor is offered in kickbacks. The number of doctors and medical professionals sent to prison in this case should make that message abundantly clear.”
Hundreds of Doctors Bribed!
Prosecutors believe BLS may be one of the largest medical frauds ever prosecuted, with the federal investigation into the scheme leading to convictions of 53 defendants including:
BLS President David Nicoll;
BLS employee Scott Nicoll;
38 physicians and physician assistants;
Three Nicoll extended-family members; and,
10 others, including numerous other BLS employees.
While the brothers’ sentences were far below the 25-year combined maximum jail time they faced after pleading guilty to conspiracy to bribe doctors and money laundering, their cooperation with prosecutors led to reduced sentences.
A one-time nurse and former pharmaceutical sales representative, David Nicoll purchased BLS in 2005, which was then a failing clinical testing laboratory. In his testimony for the government prosecution, the 44-year-old Nicoll described how his company took business away from competing labs by bribing doctors to steer blood samples to BLS for testing.
Now-defunct Biodiagnostic Laboratory Services President David Nicoll (second from left) and his brother Scott Nicoll (far right) leave a Newark courthouse in 2013 accompanied by their representatives. The two New Jersey brothers, who admitted to bribing hundreds of doctors and laundering money for fraudulent blood testing services, recently were sentenced to prison for their roles in the $100-million scheme. (Photo copyright: Associated Press.)
According to the Associated Press, Nicoll changed the lab’s fortunes by signing phony leases for space in doctors’ offices. After New Jersey outlawed the practice, BLS “switched to bribing doctors with bogus consultant agreements paid for by shell corporations formed specifically for that purpose.” Nicoll testified he bribed “the large majority” of the “probably hundreds” of doctors with whom he did business.
NJ Advance Media detailed the wide-reaching bribery scheme. It included not only monthly payments to physicians to keep the blood work orders flowing, but also big ticket payoffs, according to a U.S States Attorney’s Office District of New Jersey news release. The briberies included:
$50,000 Audi S5 turbocharged coupe;
Private jet to Key West for deep-see fishing;
Charter flight to the Super Bowl;
Tickets to a Katy Perry concert; and,
Prostitutes provided to at least five physicians.
Nicoll is alleged to have reaped huge personal gain from the fraud, including more than $33 million in distributions from the $200 million BLS received from the testing of blood specimens and related services between 2006 and 2013. In another article NJ Advance Media outlined some of the millions Nicoll spent to enhance his lifestyle, including an $800,000 Mickey Mouse-shaped backyard pool, trips on charter jets to four Super Bowls, and a collection of classic American muscle cars.
“The president and other employees of BLS bribed physicians to refer patients to their lab and order unnecessary lab tests, reaping millions of dollars, all in the name of greed,” Shantelle P. Kitchen, Acting Special Agent in Charge, IRS Criminal Investigation/Criminal Enforcement, Newark field office, stated in the U.S. Attorney’s Office statement, released in 2013 when the Nicolls’ brothers and a third BLS employee were arrested.
“Medical tests should only be run when medically necessary, not so someone can buy exotic cars and charter private jets. This type of healthcare fraud will not be tolerated and IRS-Criminal Investigations, along with our law enforcement partners, will vigorously investigate these crimes to bring the perpetrators to justice.”
More Physicians Plead Guilty to Fraud, Money Laundering, Tax Evasion
While dozens of physicians ultimately admitted to accepting bribes to refer business to BLS, New Jersey internist Frank Santangelo, MD, may have reaped the biggest payoff. Santangelo pleaded guilty in July 2013 of accepting more than $1.8 million in bribe payments from BLS for referrals, for which the lab was paid more than $6 million by Medicare and various insurance agencies between 2006 and 2012.
According to a July 8, 2015, U.S. Department of Justice (DOJ) news release, Santangelo was sentenced to 63 months in prison, fined $6,250 and forfeited $1.8 million as part of his plea agreement for violations of the Federal Travel Act, money laundering, and failing to file tax returns.
“Santangelo admitted he violated the trust of his patients, who should be able to count on their doctors’ prescribing only tests that are necessary, and recommending providers based solely on their qualifications,” stated then-U.S. Attorney Paul J. Fishman for the District of New Jersey, in the DOJ statement.
In another highly publicized case, George Roussis, a pediatrician, and his brother Nicholas Roussis, an obstetrician-gynecologist, both with practices in Staten Island, N.Y., were convicted of accepting cash payments totaling $175,000 from BLS employees and associates between 2010 and 2013. In addition, the U.S. Attorney’s Office said in a 2017 statement that BLS paid for strip club trips for the brothers, who in return funneled $1,450,000 and $250,000 of lab business to BLS, respectively. George Roussis, 45, was sentenced to 37 months in prison, while Nicholas Roussis, 49, received a 24-month sentence.
According to the U.S. Attorney’s Office statement, the government has recovered more than $15 million through forfeiture in what is believed to be a record-setting healthcare fraud case.
Criminal prosecution by federal prosecutors of both the clinical laboratory owners and the physicians who accepted bribes and illegal inducements in return for referring medical laboratory tests is not common. That fact makes this case noteworthy. It serves as a warning to all clinical laboratory professionals and the physicians who may accept kickbacks or illegal inducements that there is a risk that they can be prosecuted for these crimes.
Tuft’s proof-of-concept demonstration study shows how changes in saliva can be employed as biomarkers for development of future diagnostic monitoring devices and applications
For years, pathologists and dentists have recognized that the mouth contains many useful biomarkers for a wide range of health conditions and diseases. Now a study by a research team at Tufts University School of Engineering (Tufts) has demonstrated that a tooth-mounted sensor can reliably measure certain target markers.
In this proof-of-concept study, Tufts researchers developed a tooth-mounted sensor that monitors food consumption as it enters the body. This potentially adds behavioral data to the growing list of exploitable biomarkers available to developers of in vitro diagnostics (IVDs) and wearable medical monitoring devices. For that reason, many clinical laboratory managers and anatomic pathologists will want to track further development of this technology, which uses the mouth as the source of the markers to be measured.
A report detailing the device was first published in the scientific journal Advanced Materials in March of this year.
Sensor Reacts to Biomarkers in Saliva
The 2×2-millimeter flexible sensor consists of three layers and adheres to the tooth like a sticker. It has two gold outer rings surrounding an inner layer of bio-responsive material that is highly sensitive to glucose, salt, and alcohol. The presence of any of these substances alters the electrical properties of the sensor and incites it to transmit radio frequency waves that can be received by mobile devices.
Researchers conducting a proof-of-concept study at Tufts University School of Engineering have developed “a materials‐based strategy to add utility to traditional dielectric sensors by developing a conformal radiofrequency (RF) construct composed of an active layer encapsulated between two reverse‐facing split ring resonators,” their paper published in Advanced Materials notes. The sensor is shown above mounted to a tooth, where it reacts to the presence of certain biomarkers in the saliva, triggering the transmission of an RFID signal. This device has the potential to also measure the same biomarkers used in clinical laboratory tests. (Photo copyright: Smithsonian Magazine/Tufts University School of Engineering.)
There are many possible uses for this tooth-mounted sensor. Individuals with medical conditions such as diabetes, celiac disease, or hypertension, which require them to avoid certain substances in their diet, could benefit from utilizing a device that employs the technology under development at Tufts.
Such a gadget might also help those trying to lose weight. The creators hope to enhance the material, so it has the ability to discern additional nutrients and chemicals.
“If you can evolve the sensor and engineer it to have a database of food consumption, then you could think about nutrition management,” Fiorenzo Omenetto, PhD, Professor, Department of Biomedical Engineering at Tufts and one of the authors of the research told Smithsonian Magazine. “That could be reminding us that we’re indulging too much in sugar or something like that.”
It also could potentially detect physiological or chemical changes taking place in the body by detecting certain bio-markers in the saliva.
“In theory we can modify the bio-responsive layer in these sensors to target other chemicals. We’re really limited only by our creativity,” Omenetto noted in a news release. “We have extended common RFID [radio frequency identification] technology to a sensor package that can dynamically read and transmit information on its environment, whether it is affixed to a tooth, to skin, or any other surface.”
Other Food Intake Devices
There have been previous attempts to develop wearable devices that monitors food intake. However, those gadgets usually required the use of mouth guards and head gear, which are too cumbersome for continuous everyday use. The minute size of the Tufts tooth-mounted device renders it more practical for consumers. And, since it can be mounted anywhere on a tooth—front or back—it can be made undetectable while being worn.
“This study is an interesting proof-of-concept demonstration that small, wireless biosensors can detect changes in saliva due to the presence of compounds such as salt, sugar, and alcohol,” Ben Almquist, PhD, a lecturer in the Department of Bioengineering at Imperial College London, told Smithsonian Magazine.
“For instance, for continuous monitoring of food intake, the sensors will need to be robust enough to withstand abrasion during chewing,” Almquist noted. “In addition, foods are complex mixtures of compounds including salts, sugars and proteins, and the relative amounts of each that enter into saliva will depend on factors such as the nature of the food [i.e., cooked versus fresh], the amount of chewing, and the time in the mouth before swallowing.”
The device currently remains in the prototype stage and more testing will be needed to determine its efficacy and durability. However, the emergence of such wearable devices for medical use suggests valuable opportunities for clinical laboratories.
Because data captured from the tooth-mounted device is transmitted wirelessly, clinical laboratories could potentially store and monitor the data, compare the collected data to other medical laboratory test results for the same patient, then communicate that information to clinicians, other caregivers, and even the patients. This would be a new way for clinical laboratories to provide innovative, value-added services to healthcare professionals and consumers.
