Dec 10, 2018 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, Uncategorized
Clinical laboratory leaders will want to pay close attention to a significant development in Maryland. The state’s All-Payer Medicare program—the nation’s only all-payer hospital rate regulation system—is broadening in scope to include outpatient services starting Jan. 1. The expanded program could impact independent medical laboratories, according to the Maryland Hospital Association (MHA), which told Dark Daily that those labs may see hospitals reaching out to them.
The Centers for Medicare and Medicaid Services (CMS) and the state of Maryland expect to save $1 billion by 2023 in expanding Maryland’s existing All-Payer Model—which focused only on inpatient services since 2014—to also include primary care physicians, skilled nursing facilities, independent clinical laboratories, and more non-hospital settings, according to a CMS statement.
Healthcare Finance notes that it represents “the first time, CMS is holding a state fully at risk for the total cost of care for Medicare beneficiaries.”
Value of Precision Medicine and Coordination of Care to Clinical Labs
“If a patient receives care at a [medical] laboratory outside of a hospital, Maryland hospitals would be looking at ways to coordinate the sharing of that freestanding laboratory information, so that the hospital can coordinate the care of that patient both within and outside the hospital setting,” Erin Cunningham, Communications Manager at MHA, told Dark Daily. Such a coordinating of efforts and sharing of clinical laboratory patient data should help promote precision medicine goals for patients engaged with physicians throughout Maryland’s healthcare networks.
The test of the new program—called the Total Cost of Care (TCOC) Model—also could be an indication that Medicare officials are intent on moving both inpatient and outpatient healthcare providers away from reimbursements based on fees-for-services.
CMS and the state of Maryland said TCOC gives diverse providers incentives to coordinate, center on patients, and save Medicare per capita costs of care each year.
“What they are really doing is tracking how effective we are at managing the quality and the costs of those particular patients that are managed by the physicians and the hospitals together,” Kevin Kelbly, VP and Chief Financial Officer at Carroll Hospital in Westminster, told the Carroll County Times. “They will have set up certain parameters. If we hit those parameters, there could be a shared savings opportunity between the hospitals and the providers,” he added. (Photo copyright: LifeBridge Health.)
The TCOC runs from 2019 through 2023, when it may be extended by officials for an additional five years.
How Does it Work?
The TCOC Model, like the earlier All-Payer Model, will limit Medicare’s costs in Maryland through a per capita, population-based payment, Healthcare Finance explained.
It includes three programs, including the:
- Maryland Primary Care Program (MDPCP), designed to incentivize physician practices by giving additional per beneficiary, per month CMS payments, and incentives for physicians to reduce the number of patients hospitalize;
- Care Redesign Program (CRP), which is a way for hospitals to make incentive payments to their partners in care. In essence, rewards may be given to providers that work efficiently with the hospital to improve quality of services; and,
- Hospital Payment Program, a population-based payment model that reimburses Maryland hospitals annually for hospital services. CMS provides financial incentives to hospitals that succeed in value-based care and reducing unnecessary hospitalizations and readmissions.
CMS and Maryland officials also identified these six high-priority areas for population health improvement:
- Substance-use disorder;
- Diabetes;
- Hypertension;
- Obesity;
- Smoking; and
- Asthma.
“We are going to save about a billion dollars over the next five years, but we are also providing better quality healthcare. So it’s going to affect real people in Maryland, and it helps us keep the whole healthcare system from collapsing, quite frankly,” Maryland Gov. Larry Hogan, told the Carroll County Times.
OneCare in Vermont, Different Approach to One Payer
Maryland is not the only state to try an all-payer model. Vermont’s OneCare is a statewide accountable care organization (ACO) model involving the state’s largest payers: Medicare, Medicaid, and Blue Cross and Blue Shield of Vermont, Healthcare Dive pointed out. The program aims to increase the number of patients under risk-based contracting and, simultaneously, encourage providers to meet population health goals, a Commonwealth Fund report noted.
Both Maryland’s and Vermont’s efforts indicate that payment plans which include value-based incentives are no longer just theory. In some markets, fees-for-service payment models may be gone for good.
Clinical laboratory leaders may want to touch base with their colleagues in Maryland and Vermont to learn how labs in those states are engaging providers and performing under payment programs that, if successful, could replace existing Medicare payment models in other states.
—Donna Marie Pocius
Related Information:
Maryland’s Total Cost of Care Model
Maryland All-Payer Model Expands to Include Outpatient Services
Gov. Hogan Sees Maryland Model as Example for U.S. Healthcare
The Maryland Model
Gov. Larry Hogan, Federal Government Sign Maryland Model All-Payer Contract
CMS Expands Maryland’s All-Payer Program to Outpatient Services
Vermont’s Bold Experiment in Community Driven Healthcare Reform
Oct 13, 2017 | Uncategorized
Media coverage of a recent Orig3n promotion-and intervention from state and federal officials-reveals the level of discomfort public and policymakers have for handling the publics’ protected health information, including genetic test data
Is it appropriate to offer free genetic tests to 70,000 fans attending a professional football game? Apparently not, say federal and state healthcare regulators who took steps to block a planned free genetic test giveaway that the Baltimore Ravens and clinical laboratory company Orig3n planned to conduct on Sunday, September 17.
Genetic testing has become a mainstay of clinical laboratories and pathology groups. And it can’t be denied that the growing popularity of self-administered genetic tests could have an impact on medical laboratories’ revenue. Additionally, there’s the issue of state and federal privacy laws in the handling of protected health information (PHI) as outlined by the Health Insurance Portability and Accountability Act (HIPAA) to consider. Thus, the news that a developer of genetic self-test kits planned to distribute hundreds of free tests at an NFL football game in Baltimore quickly garnered the attention of federal and state officials, as well as the national media.
Instead of handing out t-shirts, Orig3n, a developer of genetic self-tests kits based in Boston, planned to offer free DNA tests at the September home opening game of the Baltimore Ravens. However, the giveaway was not to be. The promotion attracted the attention of the Centers for Medicare and Medicaid Services (CMS), the Maryland Department of Health (MDH), and a range of media outlets. This led to postponing the event just days before it was scheduled to happen.
According to Forbes, the test promotion claimed to provide information on genetic markers related to vitamin D deficiency, skin aging, language ability, and muscle force.
However, news coverage in The Baltimore Sun of the cancellation of the free genetic test giveaway cited concerns from CMS officials about Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements.
Orig3n told Vice in 2016 that Food and Drug Administration (FDA) approval, and other typical genetic test requirements that apply to medical laboratories, weren’t needed because their tests are non-diagnostic. However, genetic testing often does require physician orders and lab approval in the state of Maryland.
Speaking with The Baltimore Sun, Kevin Byrne, Senior VP of Public and Community Relations for the Baltimore Ravens, stated, “[We are] working with the Maryland Department of Health. Orig3n is confident it can receive the proper approvals and plans to have a fan giveaway later this season at one of our games.”
Criticism of Direct-to-Consumer (DTC) Genetic Testing
In Forbes, journalist Rita Rubin noted, “I paid $99 for the 23andMe direct-to-consumer genetic testing service several years ago. Turns out 23andMe included at least one of the four genes covered by the test Orig3n plans to give out to Ravens fans.”
23andMe is also familiar with the regulatory hurdles of DTC genetic testing. As we reported in 2013, the company received letters from the FDA demanding they cease sale of their genetic tests. These letters were followed by a $5-million class-action law suit in California claiming the test results were “meaningless.” (See Dark Daily, “23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services,” December 11, 2013.)
These concerns were echoed by Toni I. Pollin, PhD, Associate Professor at the University of Maryland School of Medicine. “There’s nothing in this that I think is a good idea,” she told The Baltimore Sun. “The tests they’re talking about doing are not going to be useful for a particular individual.”
The graph above, which is drawn from a Kalorama report on the current and future market for US Direct-to-Consumer (DTC) genetic testing, illustrates the meteoric increase in value of the DTC tests market. (Image copyright: MedCityNews/Kalorama.)
Modern Healthcare followed up on the 23andme story in 2016. Although the class-action suit eventually failed in the 9th US Circuit Court of Appeals, it took nearly two years for 23andMe to bring a portion of their tests to the market.
However, the coverage surrounding both events illustrate how wary government regulators might be to allow direct-to-consumer genetic testing to become a commonplace service. And how wary the public is to trust these new technologies and services with their protected health information.
Privacy Concerns and Media Backlash Still Common
In a September press release promoting the event, Orig3n states, “Orig3n is on a mission to advance the future of health. We believe that everyone should have direct, affordable access to their genetic information and reaching people with DNA tests on such a large scale is a natural and exciting way for us to demonstrate that.”
While Orig3n claims security is in place to protect sensitive genetic information, Bethesda, Maryland, attorney Bradley Shear and Peter Pitts, President of the Center for Medicine in the Public Interest (CMPI), both cited security concerns in the Baltimore Sun article.
The privacy and security concerns surrounding the collection and pooling of genomic and healthcare big data are not limited to the US. This trend continues to shape how innovative technologies grow and how systems and companies communicate data around the world.
A June ebriefing highlighted how even blinded data can be collated and compared to learn far more about a person or patient than a single dataset might suggest. (See Dark Daily, “Coverage of Alexion Investigation Highlights the Risk to Clinical Laboratories That Sell Blinded Medical Data,” June 21, 2017.)
Alexion (NASDAQ:ALXN), a pharmaceutical company specializing in orphan drugs, was shoved into the spotlight by Bloomberg Businessweek for aggressive marketing tactics in several countries around the world using blinded data to target patients and clinicians. The story also brought with it mentions of high-profile clinical laboratories and diagnostics providers—a potential PR nightmare for all involved.
Direct-to-consumer genetic tests offer opportunities for consumers to discover facets of their health and genetic backgrounds. However, the potential risks, security/privacy concerns, and the true value of test results continue to create hurdles for commercial service providers, as well as for pathologists and clinical laboratories.
Until public and regulatory scrutiny decreases, the value of the data gathered by these tests is determined, and standards are in place regarding security of customers’ protected health information, laboratories should remain vigilant and tread carefully when considering DTC testing as a viable opportunity to expand revenues.
—Jon Stone
Related Information:
‘DNA Day’ Planned for Ravens’ Game Undergoes Federal and State Scrutiny
Ravens Decide That Perhaps ‘DNA Day’ at M and T Bank Stadium Should Be Postponed
Orig3n Holds Inaugural Ravens DNA Day on September 17 at M and T Bank Stadium to Kick Off the Season
Beyond Bobbleheads: One NFL Team Wants to Offer Fans Free Genetic Testing
Biotech Company Offers Fitness and Beauty-focused Genetic Tests
Baltimore Ravens to Hand Out Free DNA Test Kits
Ravens Fans to Be Offered DNA Test Kits Sunday in Unusual NFL Promotion
Promotion Offering DNA Test Kits to Ravens Fans to Be Rescheduled
Football Team’s DNA Day Postponed
23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services
23andme Escapes California Class Action for Arbitration
Coverage of Alexion Investigation Highlights the Risk to Clinical Laboratories That Sell Blinded Medical Data
Sep 18, 2017 | Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Testing, Uncategorized
Owlstone Medical’s breath biopsy platform takes aim at breath biomarkers for an earlier diagnosis of cancer; could it supplant tissue biopsies sent to pathology labs?
For many years, medical laboratory scientists and pathologists have known that human breath contains molecules and substances that have the potential to be used as biomarkers for detecting different diseases and health conditions. The challenge was always how to create clinical laboratory test technology that could use human breath samples to produce accurate and clinically useful information.
Stated differently, breath, the essence of life, may contain medical laboratory test biomarkers that could provide early-detection advantages to pathology groups in their fight against cancer. Now diagnostics company Owlstone Medical—developer of the Breath Biopsy platform—is about to conduct a clinical study in collaboration with the United Kingdom’s (UK’s) National Health Service (NHS) and others to demonstrate the effectiveness of its breath-based diagnostic tests.
Anatomic pathology groups and clinical laboratory leaders know human breath contains volatile organic compounds (VOCs) that can be useful diagnostic biomarkers for medical laboratory testing. Many possible breath tests have been researched. One such test, the urea breath test for detecting Helicobacter pylori (H. pylori), has been in clinical use for 20 years. As part of the test, patients with suspect stomach ulcers or other gastric concerns, swallow a tablet with urea and exhale carbon dioxide that is measured for H. pylori bacteria.
According to an Owlstone Medical news release, the new study, called the “PAN Cancer Trial for Early Detection of Cancer in Breath,” will explore the ability of Owlstone Medical’s Breath Biopsy platform to detect cancers of the:
Current medical care standards call for these cancers to be diagnosed by analyzing biopsied tissue specimens. If Owlstone Medical’s breath test performs well during trial, it could provide advantages over traditional tissue-based cancer testing that include:
- A non-invasive approach to finding cancer earlier;
- A lower price point as compared to a tissue biopsy cancer test; and
- Faster return of test results, since tissue would not need to be collected from patients during surgical procedures and sent to medical laboratories for analysis.
“By 2030, the number of new cancer cases per year is expected to rise to around 22-million globally. Some cancers are diagnosed very late when there are few treatment options available. Non-invasive detection of cancer in breath could make a real difference to survival,” stated Richard Gilbertson, PhD, Li Ka Shing Chair of Oncology, Director of the CRUK Cambridge Center, and Oncology Department Head at University of Cambridge, in the news release.
How the Breath Biopsy Platform Works
The Breath Biopsy platform relies on Owlstone Medical’s Field Asymmetric Ion Mobility Spectrometry (FAIMS) technology, which the diagnostics company explains is a “fast means to identifying volatile organic compound biomarkers in breath.”
Billy Boyle (above), co-founder and Chief Executive Officer at Owlstone Medical, demonstrates the ReCIVA Breath Sampler. “Positive results from the PAN cancer trial could be game-changing in the fight against cancer,” he noted in the news release. “Success in this study supports our vision of saving 100,000 lives and $1.5 billion in healthcare costs.” This technology has the potential to be disruptive to anatomic pathology, which relies on the analysis of biopsied tissue to detect cancer. (Photo copyright: Owlstone Medical.)
Here is how FAIMS works in the Breast Biopsy platform, according to the Owlstone Medical website:
- Gases are exchanged between circulating blood and inhaled fresh air in the lungs;
- VOC biomarkers in the body’s circulation system pass into air in the lungs, along with oxygen, carbon dioxide, and other gases;
- Exhaled breath contains those biomarkers exiting the body;
- Because it takes one minute for blood to flow around the body, a breath sample during that time makes possible collection and analysis of VOC biomarkers of any part of the body touched by the circulatory system.
One publication compared the capture of VOCs to liquid biopsies, another possible non-invasive cancer diagnostic technique being widely researched.
“The advantage to VOCs is that they can be picked up earlier than signatures searched for in liquid biopsies, meaning cancer can be diagnosed earlier and treated more effectively,” reported Pharmaphorum in its analysis of five technology companies fighting cancer.
As part of the clinical trial, breath samples will be collected in clinic settings with the hand-held Owlstone Medical ReCIVA Breath Sampler (equipped with a dime-sized FAIMS silicon chip). The samples will come from people with a suspected cancer diagnosis who are seeking care at Cambridge University Hospital’s Addenbrooke’s Hospital. To test reliability of the biomarkers, breath samples from patients with cancer and without cancer will be analyzed.
“You’re seeing a convergence of technology now, so we can actually run large-scale clinical studies to get the data to prove odor analysis has real utility,” stated Owlstone Medical co-founder and Chief Executive Officer Billy Boyle, in a New York Times article.
Breath Tests Popular Area for Research
The company’s Breath Biopsy platform is also being tested in a clinical trial for lung cancer being funded by the UK’s NHS. The study involves 3,000 people, the New York Times article reported.
This is not the first time we have reported on Owlstone Medical. A previous e-briefing explored the company’s technology in a study focused on diagnosis of lung cancer (See Dark Daily, “In the UK, Pathologists Are Watching Phase II of a Clinical Trial for a Breathalyzer System That Uses Only a Breath Specimen to Diagnose Lung Cancer,” May 11, 2015.)
Breath tests in general—because they generally are non-invasive, fast, and cost-effective—have been the subject of several other Dark Daily e-briefings as well, including those about:
Owlstone Medical’s ability to get backing from Britain’s NHS, as well as investments to the tune of $23.5 million (the most recent coming from Aviva Ventures) is a positive sign. That Owlstone Medical’s Breath Biopsy platform is credible enough to attract such respected collaborators in the cancer trials as the Cancer Research UK Cambridge Institute (CRUK), University of Cambridge, and Cambridge University Hospitals (CUH) NHS Foundation Trust is evidence that the company’s diagnostic technology is considered to have good potential for use in clinical care.
Medical laboratory managers and pathology group stakeholders will want to monitor these developments closely. Once proven in clinical trials such as those mentioned above, breath tests have the potential to supplant other medical laboratory diagnostics and perhaps lower the number of traditional biopsies sent to labs for diagnosis of cancer.
—Donna Marie Pocius
Related Information:
Owlstone Medical and Cancer Research UK (CRUK) Initiate Pan Cancer Clinical Trial to Evaluate Breath Biopsy for Early Detection of Disease New Cancer Detecting Breath Test to Undergo Clinical Trials
Five Tech Companies Advancing Against Cancer
Aviva Invests in Owlstone Medical Breath Biopsy Platform and its Expected Drive Adoption of Breath Biopsy in Healthcare
Owlstone Medical’s ReCIVA Named Invention of the Year in Top 50 Digital Health Awards
One Day a Machine Will Smell Whether You’re Sick
Cancer Breath Biomarker: CRUK and Owlstone Start Multi-Cancer Trail
In the UK, Pathologists Are Watching Phase II of a Clinical Trial for a Breathalyzer That Uses Only a Breath Specimen to Diagnose Lung Cancer
Companies Developing Non-Invasive and Wearable Glucose-Monitoring Devices That Can Report Test Data in Real Time to Physicians and Clinical Laboratories
Wisconsin Company Developing Breath-Based Diagnostic Test Technology That Can Detect Early-Stage Infections Within Two Years of Onset
Study into Use of Breath Analysis to Monitor Lung Cancer Therapy Enhances Clinical Laboratories Ability to Support Precision Medicine
Jul 17, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Uncategorized
Another big question is whether the lobbying of medical laboratory and pathology societies can educate and convince members of Congress to delay and reform the PAMA Final Rule that uses the market price study of what private payers pay for lab tests
Coming in just five months are the deepest, most painful clinical laboratory test price cuts ever implemented by Medicare officials. During calendar 2018 alone, both the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General US Department of Health and Human Services (OIG) expect the price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) to lower spending on lab tests by $400 million!
The bad news doesn’t stop there. Lab industry observers say that significant numbers of hospital laboratories and independent lab companies are unprepared for the drop in revenue they will experience once the Medicare price cuts take effect. And, with only 157 days remaining before Jan. 1, 2018, medical laboratory executives and pathologists have precious little time to prepare their labs to operate on significantly less Medicare revenue.
PAMA Market Study of What Private Payers Pay for Clinical Laboratory Tests
Blame it on the Protecting Access to Medicare Act (PAMA) of 2014! PAMA directed CMS to conduct a market study of the lab test prices paid by private health insurers, and then use this data to set the prices of the CLFS. As many lab professionals know, CMS spent the last 24 months publishing a final price reporting rule that defined which medical laboratories must report the prices they are paid by private payers, and then collecting that data.
The data reporting period ended on May 31. In coming months, CMS will publish the new CLFS test prices and allow time for public comment.
Recognizing the need to help lab executives and pathologists understand the scale and scope of the Medicare lab test price cuts coming their way, Dark Daily and its sister publication, The Dark Report, have asked two experts with unique knowledge about this issue to give interested lab managers an up-to-the-minute intelligence briefing during an important webinar. It’s titled, “Deep Medicare Fee Cuts Are Coming to Your Clinical Laboratory in 157 Days: What You Must Do Now, Why Congress Might Intervene, and Action Steps to Protect Your Lab’s Financial Integrity,” and it happens later this week on Thursday, July 20, at 1 PM Eastern.
First Opportunity to See What Private Payers Pay for Medical Laboratory Tests
The first expert to speak is Lâle White, Executive Chairman and CEO of XIFIN, Inc., a health information technology (HIT) company headquartered in San Diego. Annually, White and her colleagues handle as many as 300 million lab test claims for hundreds of their clinical laboratory clients. Also, XIFIN is electronically interfaced with every health insurance plan in the US. These two facts mean that White has essentially the same data their lab clients reported to CMS.
During her presentation, White will show you how her company analyzed the real information from hundreds of millions of medical lab test claims that were reimbursed by thousands of private payers. You are in for a big surprise!
Learn Why Medicare Lab Test Fee Cuts Will Be Deep and Painful
XIFIN’s conclusions are based on real-world data. They demonstrate how the CMS final rule was written to direct the way federal officials calculate and set the 2018 Part B clinical laboratory test prices, and reveal why the fee cuts will be deep and painful for the lab industry’s highest-volume tests. You’ll hear facts about XIFIN’s analysis and learn to use that knowledge to model and predict precisely how deep Medicare’s revenue cuts to your lab will be when the new price schedule becomes effective on Jan. 1.
Lâle White (above left), CEO of XIFIN, Inc., spoke at the Executive War College on Laboratory and Pathology Management last May, where she shared insights about the coming price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Julie Scott Allen (above right) is Senior Vice President of the District Policy Group, Drinker Biddle, and represents the National Independent Laboratory Association (NILA) in Washington, DC. White and Allen will be speaking at a special Dark Daily webinar later this week on the current status of the Medicare fee cuts and how lab executives should respond to protect the financial integrity of their labs. (White photo copyright: The Dark Report. White photo by Linda Reineke. Allen photo copyright: Drinker Biddle.)
Because it is generally agreed that CMS officials will target the top 20 lab tests by volume for the deepest price cuts, the actual revenue drop will depend on your mix of tests and the volume of Medicare patients associated with each test. CMS says it will use the weighted median of the private payer lab test price data to determine its new Part B fees.
However, that is a flawed approach and the source of much criticism.
White will show why the weighted median generates a lower price than the use of a weighted average calculation. You’ll see the direct impact that CMS’ use of the weighted median will have on your lab’s Medicare revenue, beginning on Jan. 1.
Understanding Current Developments at CMS and Within Congress
Julie Scott Allen will be the second speaker on the July 20 webinar. She is Senior Vice President, District Policy Group, Drinker Biddle, and represents the National Independent Laboratory Association (NILA) in Washington, DC. In this role, Allen works with officials at CMS, the Department of Health and Human Services (HHS), and with members of Congress on issues relevant to the clinical laboratory members of NILA. She regularly participates as part of the Clinical Laboratory Coalition on these matters.
Allen will give you an up-to-the minute perspective on efforts by the clinical laboratory industry to educate officials within Congress, HHS, and CMS about the consequences of allowing the PAMA final rule price cuts to become effective on January 1, 2018. This is important information you can use to craft strategies to protect your lab’s financial stability. You’ll also recognize opportunities to contact your elected officials in Congress at the time when your input can make an important difference.
The message of many in the Clinical Laboratory Coalition to members of Congress is that, if the PAMA Medicare fee cuts happen as planned, many hospital lab outreach programs and community lab companies in the states and districts of the various Senators and Representatives will probably end up going out of business, filing bankruptcy, or selling to a national lab company.
Behind the Scenes on PAMA Fee Cuts, ACA Repeal-and-Replace
Allen will take you behind the scenes of the inside-the-beltway developments that relate to the coming Medicare Part B clinical laboratory fee cuts. Different players from the clinical laboratory community are in discussions with CMS officials about the need to delay and reform the implementation of these price cuts.
Meanwhile, there are several developments unfolding within Congress that affect clinical laboratories. Yes, one of them is the PAMA final rule on lab price cuts. However, congressional efforts to repeal and replace the Affordable Care Act (ACA) are creating opportunities for different medical specialties—including the profession of laboratory medicine—to advocate for needed reforms in their areas of clinical services.
When clinical laboratory and anatomic pathology leaders are informed, they are more effective in two roles:
- Protecting the clinical excellence and financial sustainability of their respective laboratories;
- Advocating with government officials and lawmakers on the issues that are important to keeping the nation’s laboratories financially viable and key contributors to improving the quality of patient care.
Full details about this important webinar are at this link. Or copy and paste this URL into your browser: https://ddaily.wpengine.com/webinar/deep-medicare-fee-cuts-are-coming-to-your-clinical-laboratory-in-157-days-what-you-must-do-now-why-congress-might-intervene-and-action-steps-to-protect-your-labs-financial-integrity to register.
—Michael McBride
Related Information:
NILA and Other Stakeholders Ask HHS to Delay the Medicare Laboratory Payment Reform Rule
Nation’s Most Vulnerable Clinical Laboratories Fear Financial Failure If Medicare Officials Cut Part B Lab Fees Using PAMA Market Price Data Final Rule
Overview of CMS-1621-F Medicare Clinical Diagnostic Laboratory Test Payment System Final Rule
Dark Report Cracks the Mystery on PAMA Pricing; Genetic Coverage Still Tough Going
XIFIN Analysis of Its Real Price Data Shows Hospital Lab Price Effect: Study Based on Hundreds of Millions of Lab Test Claims
10% PAMA Fee Cut Would Lower Medicare Pay to Laboratories by $400 Million: New OIG Report Provides Clues as to How Cuts to CLFS Prices Will Reduce Payments to Clinical Labs
CMS Issues PAMA Final Rule That Aims to Cut Medicare’s Clinical Laboratory Test Price Schedule Sharply Beginning in 2018
Deep Medicare Fee Cuts Are Coming to Your Clinical Laboratory in 157 Days: What You Must Do Now, Why Congress Might Intervene, and Action Steps to Protect Your Lab’s Financial Integrity
Jun 26, 2017 | Uncategorized
Second-generation spectral fusion microscope captures light-field images in full color using artificial intelligence and mathematical models of light to develop large-scale 3D images
Researchers in Canada have developed an inexpensive, lens-free microscope that uses artificial intelligence (AI) and mathematical models of light to develop three-dimensional (3D) images. This invention has the potential to make the clinical pathology laboratory portable and affordable. And the advancement could improve access to anatomic pathology services in remote regions and less developed countries that cannot afford conventional microscopic diagnostic equipment.
New Microscope a Boon to Pathology Laboratories Worldwide
This spectral light-fusion microscope, developed by a pair of researchers from the University of Waterloo in Ontario, uses second-generation spectral light-fusion technology for capturing light-field images in full color.
“The several-hundred-dollar microscope has no lens, and uses artificial intelligence and mathematical models of light to develop 3D images at a large scale,” states a University of Waterloo news release.
The new microscope’s low price point provides a major advantage over larger traditional microscopes that require a skilled technician to electronically “stitch” together multiple images using a machine costing several hundred thousand dollars to get the same 3D effect.
“In medicine, we know that pathology is the gold standard in helping to analyze and diagnose patients, but that standard is difficult to come by in areas that can’t afford it. This technology has the potential to make pathology labs more affordable for communities that currently don’t have access to conventional equipment,” Associate Professor of Engineering Alexander Wong, PhD, PEng, said in the University of Waterloo news release.
Wong, Associate Professor and Canada Research Chair in Medical Imaging, and Systems Design Engineer Farnoud Kazemzadeh, PhD, a Postdoctoral Fellow at Environmental Bio-Detection Products and Adjunct Professor at University of Waterloo, led the research.
“Currently the technology required to operate a pathology lab is quite expensive and is largely restricted to places such as Europe and North America, which can afford them,” Kazemzadeh noted in the news release. “It would be interesting to see what a more affordable mobile pathology lab could achieve.”
Alexander Wong, PhD, PEng (above left), and Farnoud Kazemzadeh, PhD (above right), of the University of Waterloo in Ontario, Canada, developed their new spectral light-fusion microscope to make pathology more affordable for communities that cannot access conventional equipment. They patented the first version of the microscope last year and expect their technology to be a boon to mobile anatomic pathology labs. (Photo copyright: University of Waterloo.)
Wong and Kazemzadeh described the first generation of their instrument in a research paper published in Nature Scientific Reports. In that paper, the pair demonstrated for the first time that laser light-field fusion phase contrast microscopy could detect particles at nanometer resolutions.
“We introduced a wide-field lens-free on-chip phase contrast microscopy instrument capable of detecting particles at the nanometer resolution. The instrument does not require hologram magnification, specialized sample preparation, or the use of synthetic aperture- or lateral shift-based techniques to accomplish detection of nanoparticles,” they wrote.
The researchers understand the potential of their invention to expand access to pathology. They describe the microscope as “extremely simple and economical to implement, allowing for democratization and proliferation of such systems at every level of healthcare, industry, education, or research.”
The researchers’ new second-generation device can construct nanometer-resolution images with an ultra-wide field-of-view. “The microscope captures light fields that can be analyzed using the mathematical models of light and artificial intelligence to construct 3D images that are around 100 times larger than the 2D images captured by traditional microscopes,” reported The Engineer, a United Kingdom-based publication.
Shaping the Future of Clinical Laboratories
The spectral light-fusion microscope is one example of research teams exploring how to use different technologies for the assessment of human tissue. Another example that we covered in a previous Dark Daily e-briefing involved the development of a lens-free smartphone microscope by UCLA researchers. That microscope produces holographic images of tissue samples that enable pathologists to view cancer and other abnormalities at the cellular level with the same accuracy as larger and more expensive optical microscopes.
The discipline of pathology and laboratory medicine is evolving to embrace technologies that were science fiction yesterday, but today are science fact. These technologies will continue to shape the clinical laboratory industry for years to come.
—Andrea Downing Peck
Related Information:
Lens-free Microscope Enables Full-Color Pathology at Low Cost
Artificial Intelligence-driven Imaging Research Makes Diagnosing Disease Easier
Laser Light-field Fusion for Wide-field Lens-Free On-chip Phase Contrast Microscopy of Nanoparticles
Cheap, Full-Color Images from Lens-Free Microscope
UCLA Researchers develop Lens-Free Smartphone Microscope, Pathologists May be Able to Take the Clinical Pathology Laboratory Just About Anywhere
Jun 9, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Uncategorized
New studies show number of Americans who are unwilling to reveal private health information is growing, hindering medical technology developers
Healthcare consumers appear not only to be raising their expectations of the quality of care they receive, but also in the privacy and security of their protected health information (PHI) as well. This is an important development for clinical laboratories and pathology groups, since they hold large quantities of patient test data.
News reports indicate that, due to the increase in patient distrust about privacy and security, developers of health information technology (HIT) products that collect and transmit patient data are struggling to insert their products into the broader healthcare market.
However, there is a positive side to this trend for medical laboratory professionals. Patients’ interest in tighter security and privacy protections provides pathology groups and clinical laboratory leaders with an invaluable opportunity to inform patients on their lab’s use of cybersecurity measures and to reiterate their commitment to protecting their patients’ data.
Clinical Laboratories Can Ease Patient Fears
It’s not enough that medical laboratories promote their services and efficiencies. They also must tout the capability of their laboratory information management systems (LIMS) to protect a patient’s PHI. That’s critical because recent studies indicate high proportions of healthcare consumers are becoming increasingly wary of how their healthcare data are protected.
The graphic above taken from a 2017 Accenture survey may indicate why healthcare consumer trust in an organization’s ability to secure protected health data (PHI) has eroded so deeply. (Graphic copyright: Accenture.)
Numerous reports of data hacking and security breaches have eroded healthcare consumers’ trust. Patients are more skeptical than ever about the benefits of HIT, such as:
That’s according to a national poll conducted by Black Book Market Research of more than 12,000 consumers in the fourth quarter of 2016.
The poll aimed at exploring consumers’ adoption and acceptance of HIT. It found:
- 87% of consumers are unwilling to divulge all their medical information (up from 66% in 2013);
- 70% of Americans distrust health technology (a significant increase from 10% in 2014);
- And 57% of people who underwent actual encounters with providers’ technology (including ancillary providers, such as clinical laboratories) remain skeptical of HIT.
Even with all the bells and whistles, HIT cannot penetrate the healthcare system if people don’t adopt it, a Black Book news release pointed out.
89% of Patients Withhold Information During Office Visits
Respondents to Black Book’s poll reported being especially alarmed by their data being shared (without their acknowledgement or consent) beyond their hospital and physician. This includes:
- Pharmacy prescriptions (90%);
- Mental health notes (99%); and
- Chronic conditions (81%).
Other key findings from the Black Book poll include the fact that:
- 89% of consumers withheld health information during their 2016 provider visits;
- 93% are concerned about security of their personal financial information;
- 69% say their primary care doctor does not have the technological expertise necessary for them to feel safe divulging extensive personal information.
Missing Data Compromises Care, Analytics
An article in Healthcare IT News reported that fear of breaches is translating to consumers’ reticence to share information. And, the Black Book survey states that data analytics and population health efforts by healthcare providers could be compromised due to consumer distrust, according to a FierceHealthcare article.
“Incomplete medical histories and undisclosed conditions, treatment, or medications raises obvious concerns on the reliability and usefulness of patient health data in application of risk-based analytics, care plans, modeling, payment reforms, and population health programming,” stated Doug Brown, President, Black Book, in the news release.
“This revelation should force cybersecurity solutions to the top of the technology priorities in 2017 to achieve tangible trust in big data dependability,” he concluded.
Patients/Doctors at Odds Over Use of Patient Data
According to the Black Book poll, 91% of people surveyed who use wearable medical tracking devices believe their physician’s EHR should be able to store any health-related data they wish. However, physicians responding to the provider section of the survey stated they have all the information they need. In fact, 94% of the doctors stated patient-generated data (generated by wearables) are “overwhelming, redundant, and unlikely to make a clinical difference.”
The disconnect has led to miscommunication and frustration in the doctor/patient relationship, noted a HealthITSecurity article.
Low Health Literacy Linked to Distrust of HIT
A study published in the Journal of Medical Internet Research by the University of Texas at Austin (UT) linked skepticism of HIT with low health literacy.
People who struggle to find and understand medical information tend to also be wary of health technologies, such as wearables, patient portals, and mobile apps, noted a UT news release.
Conversely, Americans with a high degree of health literacy are more likely to use fitness trackers and online portals and view them as useful and trustworthy, UT researchers stated.
This study of nearly 5,000 Americans also explored patients’ perceptions of privacy and trust in institutions. Researchers found lower health literacy was associated with more distrust and less adoption of HIT tools.
“There is a pressing need to further the understanding of how health literacy is related to HIT app adoption and usage. This will ensure that all users receive the full health benefits from these technologies in a manner that protects health information privacy, and that users engage with organizations and providers they trust,” the researchers wrote.
Cybersecurity a Priority for Labs
Cybersecurity and wearable technologies were identified as among the three primary trends (along with Social Media) facing clinical laboratories and in vitro diagnostics (IVD) manufacturers in 2017, according to insights shared by the Diagnostics Marketing Association in a recent Dark Daily e-briefing.
Another Dark Daily e-briefing summarized accounts of ransomware and cyberattacks on hospitals and medical labs in 2016. Clinical laboratory leaders are reminded to work with provider teams and appropriate experts to determine the lab’s ability to prevent and withstand cyberattacks.
Labs may glean some ideas from these cybersecurity “2017 must-haves” shared (along with others) in a Healthcare IT News article:
- Invest in a risk assessment that makes clear exactly what needs to be protected;
- Recognize that beyond medical and billing information, high tech equipment (such as lab analyzers) need to be addressed in planning.
Medical laboratory leaders should not be shy about communicating their lab’s cybersecurity priority, investment, and actions taken to keep their patient’s PHI private and secure. That message could be just what skeptical consumers need to hear and could be well received by the lab’s patients.
—Donna Marie Pocius
Related Information:
Healthcare’s Digital Divide Widens, Black Book Consumer Survey
Healthcare Digital Divide Getting Bigger and Other Bad News from Black Book
Patients Don’t Trust Health Information Technology Effects of Patient Distrust on health Data Exchange Security
Effects of Patient Distrust on health Data Exchange Security
One in Four US Consumers Have Had Their Healthcare Data Breached, Accenture Survey Reveals
New Health Literacy Digital Divide: Low Health Literacy Connected to Distrust of Health Technologies
Health Literacy and Health Technology Adoption: The Potential for a New Digital Divide
Top 10 Cybersecurity Must-Haves in 2017
Diagnostic Marketing Association’s Global Marketing Summit Will Convene in New Orleans Just Prior to the Executive War College to Discuss Primary Trends Facing IVD
MedStar Health Latest Victim in String of Ransomware Attacks on Hospitals and Medical Laboratories that Reveal the Vulnerability of Healthcare IT
