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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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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

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:

  1. Protecting the clinical excellence and financial sustainability of their respective laboratories;
  2. 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

Technological Revolution in Hospital Design and Care Delivery Will Bring Changes for Clinical Pathologists and Medical Laboratories

High-tech hospitals of the future will ‘bring the healing to the patients’ with virtual consultations and remote diagnostic/monitoring services delivering added value to patient care

Hospitals of the future may look nothing like the hospitals of today and those changes could have major implications for clinical pathologists and medical laboratory scientists.

That’s according to Samuel Smits of Gupta Strategists, a consulting firm in the Netherlands that focuses on the four pillars of the healthcare value chain: suppliers, payers, providers, and government institutions.

In an article in The Economist, Smits predicted that traditional hospitals soon will be no more. “We have reached the peak of bringing patients to the healing centers—our hospitals,” he said. “We are on the brink of bringing the healing to patients.”

The article further notes that the technological revolution on the horizon “means abandoning long-held assumptions about the delivery of care, the role of the patient, and what makes a good doctor.” Virtual consultations and remote monitoring will mean fewer patients will need in-hospital care, while those who do will find a facility that operates “more like a cross between a modern airport and a swish hotel, with mobile check-in, self-service kiosks for blood and urine tests and the like, and updates on patients’ and relatives’ phones,” the Economist article states.

Changing How Care is Delivered

The Economist predicts that “as some sophisticated diagnostics, including blood tests and virtual imaging, become available remotely, more patients will receive hospital-quality care without leaving home.”

Patrick Murray, PhD, Senior Director of Worldwide Scientific Affairs for Becton Dickinson Diagnostics in Franklin, NJ, stated in a Clinical Lab Products (CLP) article that technological advances in laboratory testing and diagnosis will enable pathologists to find increasing numbers of ways to deliver added-value to patient care.

“In my opinion, all diseases and conditions—particularly in the areas of overall wellness, women’s health, chronic diseases, and infectious disease—will benefit from the development of new tests and technologies,” Murray stated in the CLP article. “Additionally, new technologies can help meet the need to ensure traceability and seamless communication of test results not only within the lab, but also with the pharmacy, retail clinics, and physician offices, ultimately aiding in better patient management and providing more accurate insights in public health.”

Patient-and-Digital-First Hospitals

While experts predict patient-and-digital-first philosophies to be the future of hospital design, some healthcare systems already have embraced the trend. At Humber River Hospital in Toronto the future is now. An article in Modern Healthcare describes the patient-centered, high-tech, 656-bed facility, which opened in October 2015, as North America’s “first fully digital hospital.” The hospital leverages technology “wherever possible to improve quality, safety, efficiency, and customer service,” the hospital’s website states.

Humber River Hospital (above) in Toronto has been described as North America’s “first digital hospital.” It offers virtual check-in and registration as well as integrated bedside patient computer terminals that enable patients to order meals, adjust lights, play games, and access internet, television, radio, and their patient portal. (Photo copyright: Humber River Hospital.)

Humber River Hospital’s high-tech features include:

  • Robotic blood and specimen testing with results available in minutes and sent electronically to the care team with alerts for immediate attention;
  • Computerized patient documentation for immediate bedside charting;
  • Bedside computers that enable patients to control lights, use telephone and internet, order food, and review their medical, virtual check-in, and registration information;
  • A 4,500-square-foot “Command Center” (opens late 2017) will provide real-time data and predictive analytics to improve clinical, operational, and patient outcomes.

Additionally:

  • Three-fourths of the hospital’s supply chain is fully automated; and
  • Real-time locating systems (RTLS) track wandering patients and improve security for newborns.

Quality, Safety, Efficiency, Customer Service

Despite all the predicted upheaval to the status quo, John Deverill, Managing Partner at GE Healthcare Partners, expects the modern hospital will survive in some form. “There will always be hospitals where patients with complex needs go for multidisciplinary diagnosis and treatment by teams of specialists,” he stated in the Economist article. He does note, however, that stand-alone facilities for specific surgical interventions, such as joint replacements, may become the norm.

However, former Humber River Hospital President and CEO Rueben Devlin, MD, recommends hospitals not assume every high-tech healthcare innovation is worth pursuing.

“The four things that I think about are quality, safety, efficiency, and customer experience,” he stated in the Modern Healthcare article. “People talk about the Internet of things. I think about the Internet of junk. They’re nice toys but they need to show value to healthcare to make it purposeful.”

Anatomic pathology laboratories have a track record for adopting new technologies. Pathologists were early users of the remote telemedicine models, where telepathology systems enabled a pathologist to remotely control the stage and microscope of the pathologist who originated the telepathology session.

Similarly, the current generation of whole-slide imaging and digital pathology systems are gaining regulatory clearance in both Europe and the United States. If this next wave of technological innovations produces a shift in how clinical care is delivered, an opportunity will be created for clinical pathologists and medical laboratory scientists to adopt technologies that deliver added value to patients, including making inpatient hospital stays less likely.

—Andrea Downing Peck

 

Related Information:

How Hospitals Could Be Rebuilt Better Than Before

The Hospital of the Future Is Here…But it Needs more Gadgets and Bandwidth

Clinical Lab Trends 2016

NASA-like Command Centers are Coming to Hospitals

Will Growth in Number of Tele-ICU Programs in the Nation’s Hospitals Create an Opportunity for Clinical Pathologists to Deliver Added Value?

Drones Used to Deliver Clinical Laboratory Specimens in Switzerland

Demonstration project to move lab specimens by drone was successfully conducted in this alpine nation by Swiss Post and an eight-hospital health system

Delivering clinical laboratory specimens from point A to point B while maintaining the quality and integrity of critical samples is an ongoing issue for medical laboratories and pathology groups worldwide. This is especially true in countries prone to long winters and large amounts of snow. Ground transportation in those areas often experience delays, which can prevent hospitals from receiving needed test results and progressing with treatments that could save lives.

Switzerland is now taking the lead in using drones to transport medical laboratory specimens. In what is believed to be a global first, Ticino EOC, an eight-hospital medical group in Lugano, Switzerland, partnered with Swiss Post (Switzerland’s postal service) and transportation technology manufacturer Matternet of Menlo Park, Calif., to successfully transported laboratory samples between two of Ticino EOC’s hospitals by air using unmanned aerial vehicles (UAVs), commonly called drones. The samples arrived in good conditions after sailing high above blocked roadways. This demonstration project showed that drones can be used to safely deliver much needed lab specimens in both urban and remote rural medical settings.

Drones Present Opportunities for Medical Providers

The Ticino EOC group consists of eight hospital locations:

  1. Lugano Regional Hospital;
  2. Three locations of the Regional Hospital of Bellinzona and Valli (Bellinzona, Faido and Acquarossa);
  3. Mendrisio Regional Hospital;
  4. Locarno Regional Hospital;
  5. Novation Rehabilitation Clinic; and
  6. Oncological Institute of Italian Switzerland.

Matternet’s M2 drone is a quadcopter that travels up to 12 miles on a single battery charge. At just over 2.5 feet in diameter, the M2 can transport parcels up to 4.4 pounds. It cruises at about 22 miles/hour at an altitude of approximately164 to 328 feet above the ground.

According to Matternet’s website, the M2 is “engineered with encrypted communications, a parachute, precision landing, and a host of other safety features” and is “designed to be safe around people and infrastructure.”

Matternet received certification from the Swiss Federal Office for Civil Aviation (FOCA) to fly the drones at any time of the day. FOCA, along with Swiss Post, handle any regulatory issues involved in transporting human blood tissue and other medical laboratory specimens by drone and over public spaces.

“This is a big milestone for us. It means we can operate our technology throughout Switzerland. This will open a big opportunity in medical and e-commerce,” stated Andreas Raptopoulos, Matternet’s cofounder and CEO, in a TechCrunch article.

 

Matternet’s M2 drone

Matternet’s M2 drone (above) has been used to deliver biological samples between two hospitals in the town of Lugano, Switzerland. (Photo copyrights: Matternet/Swiss Post.)

An additional safety certification is still needed before Swiss Post adds medical drone deliveries to their official services. The packaging that will contain blood samples or any other biohazard materials still requires approval. Swiss Post hopes to be using the drone service regularly for the transportation of lab samples by 2018.

Each drone can be launched using a smartphone application. The launching and landing sites transmit an infrared signal that the drone homes in on. It then delivers the specimens to their predetermined destinations. In the event of an in-flight failure, the drone discharges a parachute and lands.

Delivery by UAV Not New to Healthcare

This is not the first venture to use drones in the field of healthcare. Zipline, a logistics company based in Silicon Valley, is working with the Rwandan government to deliver blood supplies to rural clinics by drone. The company’s website states that, as of May 2017, they have completed over 350 deliveries of blood products to hospitals in Rwanda.

An article appearing in the scientific journal PLOS ONE, highlighted how important drones can be in serving people in rural and economically impoverished areas. Drones can provide healthcare workers with fast access to lab specimens for diagnosis and treatment in areas where roads are impassable or do not exist.

Researchers for that study proved that the movement of the drones does not have any effect on blood samples, which is a crucial element in transporting medical laboratory specimens.

In a Johns Hopkins Medicine news release, one of the authors of the paper, Timothy Kien Amukele, MD, PhD, Assistant Professor of Pathology at Johns Hopkins University, noted the research team had initial concerns about the effects the acceleration and jostling of the drones would have on the laboratory specimens.

“Such movements could have destroyed blood cells or prompted blood to coagulate and I thought all kinds of blood tests might be affected. But our study shows they weren’t, so that was cool,” Amukele stated.

Pathologist Timothy Amukele, MD, PhD

Pathologist Timothy Amukele, MD, PhD (above left), teamed with engineers at Johns Hopkins to develop a drone courier system capable of transporting blood to clinical laboratories. (Photo copyright: Johns Hopkins Medicine.)

For the study, Amukele and his team collected blood samples from 56 healthy volunteers and drove the samples to a drone launching field. Half of the samples were then driven to a clinical laboratory for processing and the other half were placed on the drones for flights lasting from six to 38 minutes.

Comparison of Clinical Lab Specimens Transported by Ground and by Drone

Both the flown and the non-flown samples underwent 33 common medical laboratory tests. The test results showed almost no difference between the two groups of samples. A test for carbon dioxide was the only one that generated different results, but the team did not know if that was due to the movement of the drones or the fact that the samples sat for up to eight hours before being tested.

Amukele is taking part in a collaboration between Johns Hopkins and Makerere University in Uganda. He noted that they would like to perform a study in a more remote location, possibly in Africa, where clinical laboratories can sometimes be more than 60-miles from clinics.

“A drone could go 100 km [approximately 62 miles] in 40 minutes,” noted Amukele in the Johns Hopkins news release. “They’re less expensive than motorcycles, are not subject to traffic delays, and the technology already exists for the drone to be programmed to ‘home’ to certain GPS coordinates, like a carrier pigeon.”

Opportunities for Clinical Laboratories

Use of drones is subject to each country’s laws and regulations. In the US, drone use is regulated by guidelines established by the Federal Aviation Administration (FAA). In some cases, the drone must be registered with the FAA and the operator must have a remote pilot certificate to legally fly a drone.

These projects highlight the critical need for cost-effective, safe, dependable transportation of biological materials in a timely manner. For pathologists and clinical laboratories, drones could prove to be another opportunity to provide high-quality, value- added services to healthcare consumers and other medical professionals.

—JP Schlingman

Related Information:

Swiss Post Using Drones to Transport Medical Samples between Hospitals

Medical Drones Poised to Take Off

Doctors Test Drones to Speed Up Delivery of Lab Tests

Drones Can Be Used to Fly Blood Samples to Remote Medical Clinics

Drones Deliver Healthcare

Medical Drones Will Thrive in Healthcare: A Safe Road to Health

Meet Matternet, the Drone Delivery Startup That’s Actually Delivering

Matternet Cleared to Fly Blood Samples in Delivery Drones over Swiss Cities

Swiss Post Drone to Fly Laboratory Samples for Ticino Hospitals

Proof-of-Concept Study Shows Successful Transport of Blood Samples with Small Drones

Blood from the Sky: Zipline’s Ambitious Medical Drone Delivery in Africa

CMS Missed 96 Hospitals with Suspected HAI Reporting Due to Limited Use of Analytics, OIG Report Reveals

OIG suggests better use of analytics by CMS could prevent gaming of the system by providers; clinical laboratories can help through test utilization management technology

It may come as a surprise to many hospital-based pathologists and clinical laboratory managers that the Centers for Medicare and Medicaid Services (CMS) has reason to suspect that some hospitals are “gaming” the system in how they report hospital-acquired infections (HAIs).

In 2015, CMS implemented the Hospital-Acquired Condition Reduction Program (HACRP) as part of the Patient Protection and Affordable Care Act (ACA). The HACRP program incentivizes hospitals to lower their HAI rates by adjusting reimbursements according to the inpatient quality reporting (hospital IQR) data provided by the healthcare providers. Hospital IQR data is the basis on which CMS validates a hospital’s HAI rate (among other things CMS is tracking) to determine the hospital’s reimbursement rate for that year.

However, an April 2017 report by the Office of the Inspector General US Department of Health and Human Services (OIG) noted that CMS was not doing enough to identify and target hospitals with abnormal reporting of HAIs.

The OIG reported:

  • CMS, in 2016, met its regulatory requirement to validate inpatient quality reporting data;
  • It reviewed data of 400 randomly selected hospitals as well as 49 hospitals targeted for failing to report half their HAIs, or for low scores in the prior year’s validation process;

However, OIG also reported that CMS did not include hospitals that displayed abnormal data patterns in its targeted sample. Targeting those hospitals, according to the OIG, could identify inaccurate reporting.

CMS staff had identified 96 hospitals with aberrant data patterns, but did not target them for validation—even though the agency can select up to 200 targeted hospitals for review, Becker’s Hospital Review pointed out.

Dollars More Important than Deaths

According to the OIG report, Medicare excluded in its investigation dozens of hospitals with suspected HAI reporting. This is odd since the CMS and the Centers for Disease Control (CDC) apparently are aware that some healthcare providers have manipulated data to improve their quality measure scores and thus increase their reimbursement rates.

“Collecting and analyzing quality data is increasingly central to Medicare programs that link payments to quality and value. Therefore, it is important for CMS to ensure that hospitals are not gaming [manipulating data to improve scores] their reporting of quality data,” the OIG report noted.

“There are greater requirements for what a company says about a washing machine’s performance than there is for a hospital on quality of care. And this needs to change,” stated Peter Pronovost, MD, PhD, in the Kaiser Health News article. “We require auditing of financial data, but we don’t require auditing of healthcare quality data, and that implies that dollars are more important than deaths.” Pronovost is Senior Vice President for Patient Safety and Quality at Johns Hopkins University School of Medicine.

 

Peter Pronovost, MD, PhD

Peter Pronovost, MD, PhD (above) testifying on preventable deaths before the Senate Subcommittee on Primary Health and Aging in 2014. He is Senior Vice President for Patient Safety and Quality at Johns Hopkins University School of Medicine in Baltimore. Pronovost told Kaiser Health News that there are no uniform standards for reviewing data that hospitals report to Medicare. (Photo copyright: US Senate Committee on Health, Education, Labor and Pensions.)

Medicare Missed Hospitals with Suspected HAI Data

CMS should have done an in-depth review of many hospitals that submitted “aberrant data patterns” in 2013 and 2014, the OIG stated in its report. According to a Kaiser Health News article, such patterns could include:

  • A rapid change in results;
  • Improbably low infection rates; and
  • Assertions that infections nearly always struck before patients arrived at the hospital.

“There’s a certain amount of blind faith that hospitals are going to tell the truth. It’s a bit much to expect that if they had a bad record they are going to fess up to it,” noted Lisa McGiffert, Director of the Safe Patient Project at Consumers Union, in the Kaiser Health News article.

CMS Needs Better Data Analytics

So, what does the OIG advise CMS to do? The agency called for “better use of analytics to ensure the integrity of hospital-reported quality data.” Specifically, OIG suggested CMS:

  • Identify hospitals with abnormal percentages of patients who had infections on admission;
  • Apply risk scores to identify hospitals with high propensity to manipulate reporting;
  • Use experiences to create and improve models that identify hospitals most likely to game their reporting.

CMS’ Administrator Seema Verma reportedly responded, “We will continue to evaluate the use of better analytics as feasible, based on Medicare’s operational capabilities.”

Medical Laboratory Diagnostic Testing Part of Gaming the System

A 2015 CMS/CDC joint statement noted “three ways that hospitals may be deviating from CDC’s definitions for reportable HAIs,” and two involve diagnostic test ordering. According to the OIG report, they include:

  • Overculturing: Diagnostic tests may be overutilized by providers in absence of clinical symptoms. Hospitals may use positive results to game their data by claiming infections that appeared days later were present on admission and thus not reportable.
  • Underculturing: Hospitals underculture when they do not order diagnostic tests in the presence of clinical symptoms. By not ordering the test, the hospital does not learn whether the patient truly has an infection and, therefore, the hospital does not have to report it.
  • Adjudication: Hospital administrative staff may inappropriately overrule those who report infections. HAIs are, therefore, not shared.

Clinical Laboratories Can Help

One in 25 people each day receives an HAI, CDC estimates. The OIG findings should be a reminder to medical laboratories and pathology groups that quality measures and patient outcomes are often transparent to media, patients, and the public.

One way medical laboratories in hospitals and health systems can help is by investing in utilization management technology and protocols that ensure appropriate lab test utilization. Informing doctors on the availability of appropriate diagnostic tests based on patients’ existing conditions, unique physiologies, or medical histories, could help prevent hospitals from inadvertently or deliberately game the system.

Clearly, transparency in healthcare is increasing. That means there will be more news stories revealing federal agencies’ failures to respond to healthcare data in ways that could have protected patients and the public. Clinical laboratories don’t want to be included in negative reporting.

—Donna Marie Pocius

Related Content:

CMS Validated Hospital Inpatient Quality Reporting Program Data, But Should Use Additional Tools to Identify Gaming

Medicare Failed to Investigate Suspicious Infection Cases from 96 Hospitals

CMS Can Do More to Validate Hospital-Reported Infection Data, OIG Report Finds

Study Suggests Medical Errors Now Third Leading Cause of Death in the US

Research Study at Johns Hopkins University Reveals CDC Does Not Record Medical Errors in Annual Mortality Report, Yet Such Errors Are Third Leading Cause of Death

Biggest Opportunity for Clinical Laboratory Industry is Utilization Management of Lab Tests, But Only If It Is Done Well

Lessons from the Pioneers: Reporting Healthcare-Associated Infections

Webinar: Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value 

Studies Show Utilization Management Systems Help Clinical Laboratories Remove Physician Uncertainty Over Availability of Diagnostic Tests and How to Properly Interpret Results

Researchers note medical laboratories uniquely qualified to help doctors optimize lab test utilization, and to educate physicians on testing trends and improvements

Automation and informatics have revolutionized the modern medical laboratory. These same technologies also are powering the next generation of healthcare through precision medicine, genomics, and an increased ability to assess and leverage population health trends. In fact, exciting work is being done to use these technologies to help physicians and clinical laboratory professionals better work together.

When it comes to how physicians order and use medical laboratory tests, changing their long-standing habits can be a lengthy process. By using dedicated systems to define proper lab test usage, track lab orders and patient outcomes, and share data between clinical laboratory and healthcare environments, pathologists, medical laboratory scientists, and physicians could seamlessly access the knowledge needed to improve decision making.

Low-Value versus High-Value Care Ordering

Research published recently in the Journal of the American Medical Association Internal Medicine (JAMA Internal Medicine) investigated the order rates and utilization of low-value medical laboratory services and other diagnostic tests associated with headaches, respiratory tract infections, and back pain.

Their findings indicated that physicians in hospital-based practices ordered more “low-value care” than physicians in community-based practices. According to the research, low-value care includes:

The researchers found similar patterns in specialty referrals when comparing hospital-owned community practices and physician-owned practices.

The study authors noted, “Visits with a generalist other than the patient’s primary care provider were associated with greater provision of low-value care, but mainly within hospital-based settings.”

Medical Laboratories Critical to Increasing Care Value/Reimbursements

According to the study, physicians often develop routines and habits when ordering diagnostic testing and when utilizing clinical laboratory services. By taking a proactive role in educating physicians and managing lab test utilization, laboratories could assist physicians in shifting these habits and reduce the number of low-value or outmoded tests ordered.

Avoiding low-value or unwarranted testing:

  • Reduces order load on the laboratory;
  • Improves efficiency for healthcare providers; and
  • Improves the quality of care for patients.

This is particularly critical as value-based care continues to change the way both laboratories and healthcare facilities get reimbursed for services.

In a press release, Janet B. Kreizman, CEO of the American Association for Clinical Chemistry (AACC) stated, “The changing Medicare payment paradigm creates new opportunities for health systems to advance patient care while more efficiently and effectively utilizing their resources. Laboratory medicine experts are uniquely positioned to ensure this is achieved by working with physicians to devise optimal diagnostic and therapeutic protocols, leading to better health outcomes and reduced costs.”

 

Graphic above from the Institutes of Medicine (IOM) report, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America.” (Graphic copyright: National Academy of Sciences, Engineering, and Medicine.)

A study published in the American Journal of Clinical Pathology (AJCP) noted that among 32,000 primary care physicians surveyed:

  • 7% were uncertain about which diagnostic tests to order;
  • 3% were uncertain on how to interpret results; and
  • Respondents only consulted with pathology or laboratory experts 6% of the time.

Thus, an important opportunity exists for laboratory experts to work with PCPs—both within hospitals and outpatient settings—to further improve understanding of the ever-shifting menu of testing options and how to best utilize available lab services.

Optimizing the Cost and Safety of Care through Cooperation

In “‘Choosing Wisely’ Program Wants to Encourage Better Utilization of Clinical Pathology Laboratory Tests,” Dark Daily reported on a program created by the American Board of Internal Medicine Foundation (ABIMF) and Consumer Reports that sought to identify overused diagnostic procedures and medical laboratory testing.

The program asked nearly 400,000 physicians to name five diagnostic test and procedures related to their specialty that offered questionable value to patients and outcomes. In a Kaiser Health News (KHN) article, Daniel Wolfson, COO at ABIMF, attributed the “Choosing Wisely” campaign to launching a national conversation on unwarranted and low-value care.

The KHN report also noted the impact of “Choosing Wisely” on Cedars-Sinai in Los Angeles, one of the largest hospitals in the nation. Harry Sax, MD, Executive Vice Chairman for Surgery at Cedars-Sinai explained how the hospital avoided $6-million in spending in 2013 alone by implementing program recommendations, and by being more selective regarding tests and procedures utilized at the hospital.

Using Lab Utilization Management Technology to Improve Testing Value

A study published in the American Journal of Clinical Pathology (AJCP) highlights how combining expert laboratory advice with a dedicated electronic laboratory utilization management system might shape the future of testing and help educate healthcare providers on the diagnostic options available to them.

The authors of the AJCP study compared testing costs at the Richard L. Roudebush VA Medical Center in Indianapolis before and after implementing an electronic laboratory utilization management system. They attributed six-figure savings to a reduction in high-volume large-panel testing and redundant tests. Savings were realized without increasing length-of-stay or adversely effecting patient care.

Dark Daily recently reported on the value to clinical laboratories of implementing utilization management systems in “Biggest Opportunity for Clinical Laboratory Industry is Utilization Management of Lab Tests, But Only If It Is Done Well.”

As big data continues to shape the future of healthcare, and clinical laboratories continue to implement lean laboratory routines to maintain growth, these systems could offer increased opportunities to help physicians become better at ordering the right test at the right time for the right patient, while helping the clinical laboratories performing these tests to further trim waste, increase the value of care, increase reimbursement, and improve outcomes for patients.

—Jon Stone

 

Related Information:

Hospital-based Physicians Provide More Unnecessary Services

Association of Primary Care Practice Location and Ownership with the Provision of Low-value Care in the United States

Lab Experts Help Providers Reduce Low-value Resource Use, Costs

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Primary Care Physicians and the Laboratory: Now and the Future

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Expected Increase in Demand for Remote Health Monitoring of America’s Elderly Presents Opportunities for Clinical Laboratories to Provide Services

As our population continues to age, the demand increases for more clinical services and medical laboratory tests that cater to the growing needs of senior citizens

Elderly patients represent the fastest growing healthcare demographic in America. Thus, it is no surprise that healthcare professional in the field of Elderly Care are interested in technologies that enable them to remotely monitor the senior citizens under their care.

Telehealth devices, for example, that monitor a patient’s condition and transmits reports/alerts to primary care doctors and clinical laboratories when biomarkers deviate from set parameters, are becoming frontline tools for ambulatory and home-health practices.

Even emergency departments (EDs) are adopting remote-healthcare, as Dark Daily reported in “Community Paramedicine Brings Emergency Care into Patients’ Homes, Could Increase Clinical Laboratory Specimens Collected in These Settings.”

Healthcare and the Aging Consumer

According to the American Association of Retired Persons (AARP), there are more than 108 million people in the United States over the age of 50. This figure includes over 76 million baby boomers, those born between 1946 and 1964. The number of people over the age of 50 is expected to grow by 19 million over the next decade.

At the latest Aging 2.0 OPTIMIZE conference in San Francisco, Jaana Remes, PhD, economist and partner at the McKinsey Global Institute stated, “In healthcare, there is a clear shift in consumption, and its mainly from a consumer we don’t hear a lot about: the aging consumer. There are a lot of attitudes of stereotypes, and they are still less well known,” noted a MobiHealthNews article. “There is more equality, more diversity, they are more likely to be working later, more likely to be single, they are the most educated older generation yet, and they are much more likely to be tech savvy.”  

Remes added it is important that new technology—such as apps, remote-monitoring systems, and platforms for care teams—are designed with the understanding that seniors will use them. “We need to make things that are suitable, particularly for the 75 and older crowd, to customize their needs,” she stated. “Fewer younger people are taking care of their parents.”

Elderly Care is Four-Five Times More Costly

A report by the National Center for Biotechnology Information (NCBI) states that healthcare costs rise exponentially after a person reaches age 50. According to the report, annual healthcare costs for the elderly are four to five times higher than individuals in their teens.

“Life expectancy has changed dramatically in the US, but while people are living longer, they aren’t necessarily living healthier,” stated Bruce Chernof, MD, President and CEO, The SCAN Foundation, in the MobiHealthNews article. “Maybe they are living with higher function and longer, but they are living with more chronic diseases. Where could tech play a role?” The SCAN Foundation is an independent public charity dedicated to improving care for older adults.

Critical Need for Home Health Monitoring Tools

As America’s population ages, the demand for home healthcare services is escalating at significant rates. According to a report from Zion Market Research, the global market for home healthcare services was valued at $229 billion in 2015. The report also states that that number should reach $391 billion by 2021.

Because families are becoming smaller, and a higher percentage of older adults are single than in the past, there is a greater need for caregivers who provide in-home care. Approximately two thirds of persons receiving home healthcare obtain that care from unpaid relatives and friends.

“The need for technology-enabled caregivers and care support goes up,” noted Chernof in the MobiHealthNews article. “So, we have to look mainly at ‘what is the problem I am trying to solve?’”

Fujitsu Laboratories Limited and Fujitsu Ireland Ltd. ran the KIDUKU Project from 2013-2016. The research initiative was designed to “provide monitoring services and assisted independent living for senior citizens and patients who live in smart houses.” (Graphic copyright: Fujitsu Laboratories Limited.)

Since the largest group of healthcare consumers are seniors, it is crucial to create tools that improve their quality of life and the effectiveness of the healthcare they receive. These tools include monitoring services for both healthcare and home care providers.

“On the pure technology side, it’s simple things like a dashboard report that family members can access that indicate what sensors at home they can interact with, enabling them to track patterns at home, so we can have the family get together and talk, rather than having to bring someone in every few weeks or months and try to figure out the problem moving backwards,” stated Lily Sarafan in the MobiHealthNews article. Sarafan is President and CEO of Home Care Assistance in San Francisco.

According to Sarafan, a significant part of senior care and monitoring is creating technology that tracks patient health and includes a personalized approach to care.

“Collecting better data that we can share with our 10,000 referral partners around the country on what’s happening in that white space, what happens in between when someone sees their healthcare provider two or three times per year because of an emergency or a check-up, and now we’re potentially interacting with a patient 24/7 for months or even years,” she stated. “That’s what puts us in the best possible situation to share data across players in the ecosystem and prevent preventable hospital admissions.”

Clinical Laboratories Could Provide Services; Earn Revenue

It might seem like science fiction now, but there may come a day soon when chronic disease sufferers can opt to have sensors implanted that monitor their conditions 24/7 and collect data that gets transmitted automatically to primary care doctors and other healthcare professionals.

When that happens, some innovative medical laboratories will likely develop business models for monitoring remote devices and collecting revenue for providing the service. By combining the collected data from those devices with a patient’s lab test data, they could identify for medical professionals when interventions are needed for certain conditions.

—JP Schlingman

Related Information:

What the Senior and Aging Care Industry Wants from Digital Health Innovators

A Snapshot of Global Innovation in Aging and Senior Care

How to Help Your Elderly Patients Adapt to Healthcare Technology

Community Paramedicine Brings Emergency Care into Patients’ Homes, Could Increase Clinical Laboratory Specimens Collected in These Settings

From Micro-hospitals to Mobile ERs: New Models of Healthcare Create Challenges and Opportunities for Pathologists and Medical Laboratories

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