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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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HHS Office of Inspector General Report Finds ‘Steep Decreases’ in Medicare Beneficiaries Receiving Clinical Laboratory Testing During COVID-19 Pandemic’s Early Months

OIG warns that without adequate clinical laboratory testing healthcare organizations could see more deaths and increased spending

Clinical laboratory leaders and pathologists know that lab test volume decreased dramatically during the early months of the COVID-19 pandemic. That was primarily because community lockdowns stopped people from seeing their doctors for the standard range of chronic health conditions, many of which require clinical laboratory tests for diagnosis and chronic disease management.

This early and substantial drop in the volume of medical laboratory testing done in the early months of the pandemic has been confirmed and quantified in a recently published report by US Department of Health and Human Services (HHS) Office of Inspector General (OIG). The report describes the  “steep decreases” in the number of Medicare beneficiaries receiving Medicare Part B lab tests in early 2020, by month, as follows:

• 24% reduction in Medicare Part B test volumes in March
• 53% in April
• 30% in May

The decline of Medicare patients visiting clinical laboratories continued through the balance of 2020. During the first 10 months of the pandemic—March through December 2020—Medicare beneficiaries who pursued lab testing decreased by about 9% compared to the same 10-month period in 2019, according to a news release.

This is a strong indicator that the government’s response to the pandemic had a measurable effect on clinical laboratory testing volume among all age groups, especially among the elderly.

Kyle Fetter

“The cumulative decline in lab test volume across all client labs for [March 9 to April 12] was just over 40%. But in that time, some of our lab customers were hit with a decline of maybe 50% to 60% in test volume,” Kyle Fetter (above), COO, XIFIN, told The Dark Report in 2020. Clinical laboratory testing that originates from a routine patient visit to a doctor—such as blood testing—may have been affected the most, Fetter explained. (Photo copyright: XIFIN.)

Clinical Laboratory Tests Key to Well-being of Patients with Chronic Conditions 

The OIG study was limited to Medicare beneficiaries and thus did not provide information about testing fall-off among people who have private health insurance. But in “From Mid-March, Labs Saw Big Drop in Revenue,” Dark Daily’s sister publication The Dark Report reported early in 2020 on a 40% decline in test volumes and the pandemic’s varying effects on clinical labs, anatomic pathology (AP) groups, and AP subspecialties.

The OIG’s Report in Brief on its study recognized that medical laboratory testing is critical to helping healthcare providers manage chronic conditions that affect patients’ well-being and increase their healthcare costs.

“Lab tests are important for beneficiaries with chronic medical conditions, which are associated with hospitalizations, billions of dollars in Medicare costs, and deaths,” the OIG said.

The OIG audit collected data on the numbers of Medicare beneficiaries receiving all lab tests as well as specific lab tests for Type 2 diabetes mellitus, Chronic kidney disease, and Chronic ischemic heart disease during the period March through December 2020, as compared to the same months in 2019.

According to the OIG’s report:

  • Beneficiaries receiving clinical laboratory tests in general decreased 9%.
  • Beneficiaries with type 2 diabetes receiving lab tests declined 14%.
  • Beneficiaries with chronic kidney disease getting lab tests fell 11%.
  • Beneficiaries with chronic ischemic heart disease receiving lab tests decreased 19%.

“The information may be useful to stakeholders involved in ensuring that beneficiaries avoid the potential bad outcomes that may result from missing or delaying appropriate care,” the report noted.

Overall, 23.7 million Medicare beneficiaries received medical laboratory tests during the first 10 months of the pandemic, down 2.4 million from 26.1 million in 2019, the OIG reported.

Overall Medicare lab test volume and spending also declined during the reported period:

  • Part B clinical laboratory tests for Medicare beneficiaries decreased 15% from 419.9 million tests in 2019 to 358.4 million tests in the first 10 months of the pandemic.
  • Medicare spending for these tests decreased 16% from $6.6 billion in 2019 to $5.5 billion during the first 10 months of the pandemic.

“OIG’s audit of Part B clinical laboratory tests, reimbursed under the Clinical Laboratory Fee Schedule (CLFS) is a useful benchmark for how Medicare beneficiaries received fewer lab tests during the pandemic, especially during the early months,” said Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report.

Medical Laboratory Tests That Were Down Most During COVID-19

The following 10 clinical laboratory tests experienced a 10% or more decline in Medicare beneficiaries seeking them during the pandemic period as compared to pre-pandemic, according to the OIG report:

  • Basic metabolic panel down 18% to 4.8 million Medicare patients.
  • Urinalysis with microscope analysis down 13% to 4.6 million Medicare recipients.
  • Automated urinalysis down 16% to 3.4 million Medicare beneficiaries.
  • Vitamin B12 decreased 11% to 3.4 million Medicare patients.
  • Complete blood count (CBC) down 13% to 3.2 million Medicare beneficiaries.
  • Comprehensive urine culture test fell 16% to three million Medicare patients.
  • Uric acid level blood down 13% to 1.9 million Medicare beneficiaries.
  • Evaluation of antimicrobial drug decreased 17% to 1.74 million Medicare patients.
  • Folic acid level down 12% to 1.73 million Medicare beneficiaries.
  • Urinalysis manual test plunged 28% to 1.4 million Medicare patients.

Beyond Medicare, Clinical Laboratory Test Volume Dropped 40%

OIG was not the only organization to analyze medical laboratory testing volume during the pandemic’s early phase.

The Dark Report correlated data tracked by XIFIN, a San Diego-based health information technology (HIT) company providing revenue cycle management services to clinical laboratories and pathology groups. XIFIN’s collected data showed a steep drop in routine test volume as COVID-19 testing ramped up.

“Starting in the third week of March, we saw medical laboratories suffer a sharp drop in routine testing. But at about the same time, many labs began to offset those revenue losses with testing for the novel coronavirus,” Kyle Fetter, XIFIN’s then Executive Vice President and General Manager of Diagnostic Services told The Dark Report in 2020. Fetter is now XIFIN’S Chief Operating Officer.

“Over four weeks beginning March 9, we saw a cumulative drop of over 40% in test volume from all of our lab clients,” he added.

According to XIFIN’s data, lab specialty organizations experienced the following drop in routine testing during the period March 9 to April 16, 2020:

  • 58% at clinical laboratories.
  • 61% at hospital outreach laboratories.
  • 52% at molecular and genetic testing laboratories.
  • 44% at anatomic pathology (AP) groups.
  • 70% to 80% at AP dermatology and other AP subspecialties.

Many medical laboratories are still recovering from the COVID-19 pandemic’s effects on testing volume.

Notably, the OIG’s report acknowledges the importance of adequate clinical laboratory testing and declares that—without these essential lab tests to manage some healthcare conditions—the healthcare industry could see increased morbidity, deaths, and Medicare spending.   

Donna Marie Pocius

Related Information:

Full Report: The Number of Beneficiaries Who Received Medicare Part B Clinical Laboratory Tests Decreased During the First 10 Months of the COVID-19 Pandemic

Press Release: The Number of Beneficiaries Who Received Medicare Part B Clinical Laboratory Tests Decreased During the First 10 Months of the COVID-19 Pandemic 

Report-in-Brief: The Number of Beneficiaries Who Received Medicare Part B Clinical Laboratory Tests Decreased During the First 10 Months of the COVID-19 Pandemic

From Mid-March Labs Saw Big Drop in Revenue

Researchers Develop ‘Smart’ Microneedle Adhesive Bandage System for Monitoring Sodium, Glucose, pH, and More

Platform could be next breakthrough in quest for painless technology to replace in-patient phlebotomy blood draws for many clinical laboratory tests

In a proof-of-concept study, scientists from Israel and China have developed a “smart” microneedle adhesive bandage that measures and monitors in real time three critical biomarkers that currently require invasive blood draws for medical laboratory tests commonly performed on patients in hospitals.

The “smart” microneedle system developed by Israeli scientists from Technion-Israel Institute of Technology working with their Chinese counterparts from the Eighth Affiliated Hospital Sun Yat-Sen University in Shenzhen, Lanzhou University, and Xidian University in Xi’an, continuously monitors patients’ sodium, glucose, and pH levels.

According to a Technion news release, the microneedles are short, thin, and relatively painless because they only extend through the outer layer of skin to reach the interstitial fluid underneath. The needle system attaches to the patient’s skin using an adhesive patch and transfers data wirelessly to both doctor and patient in real time through cloud and Internet of Things (IoT) technologies.

Such a novel technology that allows inpatients to be monitored for key biomarkers without the need for a phlebotomist to collect blood for testing will be attractive and would likely improve the patient’s experience.

It also could reduce the volume of specimen required, potentially eliminating the invasive specimen collection procedure altogether.

The researchers published their findings in the journal Advanced Materials, titled, “A Wearable Microneedle-Based Extended Gate Transistor for Real-Time Detection of Sodium in Interstitial Fluids.”

Hossam Haick, PhD
“To adapt the technology to daily life, we have developed a unique [adhesive bandage] made of a flexible and soft polymer that stretches and contracts along with the skin and therefore does not interfere with any action whatsoever,” said Hossam Haick, PhD (above), in a Technion news release. “Since it is important for us that the system is available to everyone, we made sure to use relatively inexpensive materials, so the final product will not be expensive. The technology we have developed represents a leap forward in diagnosing diseases and continuous physiological monitoring at home and in the clinic.” Such a real-time monitoring device could eliminate clinical laboratory testing for certain biomarkers that currently require invasive blood draws. (Photo copyright: Technion-Israel Institute of Technology.)

Leap Forward in Diagnostic Testing and Disease Monitoring

As pathologists and medical laboratory scientists are aware, sodium is a prominent prognostic biomarker for assessing certain blood conditions such as dysnatremia, the presence of too much or too little sodium. It’s an essential element found in blood cells and blood fluid that plays a vital role in transmitting signals to the nervous system, as well as in other biological functions.

Currently, a patient’s sodium levels are monitored using a sodium blood test, which may be included in both a basic metabolic panel and a comprehensive metabolic panel.

Led by Hossam Haick, PhD, head of the LNDB (Laboratory for Nanomaterials-based Devices) group and Dean of Certification Studies at Technion, the team of scientists tested their device’s effectiveness at monitoring patients’ blood for both hypernatremia (high concentration of sodium in the blood) as well as hyponatremia (low concentration of sodium in the blood).

Both conditions can affect neurological function and lead to loss of consciousness and coma. Thus, early monitoring is critical.

“As of now, detection and monitoring of sodium levels in the human body is carried out by means of laborious and bulky laboratory equipment, or by offline analysis of various bodily fluids,” the study’s authors explained in the news release. Use of the smart microneedle patch, they added, allows the patient to continue about their day as normal, as well as gives their doctor time to attend to more patients.

The “innovative stretchable, skin-conformal and fast-response microneedle extended-gate FET (field-effect transistor) biosensor [integrated with] a wireless-data transmitter and the Internet-of-Things cloud for real-time monitoring and long-term analysis [could] eventually help [bring] unlimited possibilities for efficient medical care and accurate clinical decision-making,” noted the study’s authors in Advanced Materials.

More research will be needed to determine whether this latest medical technology breakthrough will lead to a viable minimally invasive method for measuring, diagnosing, and monitoring medical conditions, but Technion’s platform appears to be another step toward a long-sought alternative to painful blood draws.

Further, pathologists and clinical laboratory managers should expect more products to hit the market that are designed to collect a lab specimen without the need for a trained phlebotomist. Companies developing these products recognize that recruiting and retaining trained phlebotomist is an ongoing concern for medical labs. Thus, to have a method of collecting a lab specimen that is simple and can be done by anyone—including patients themselves—would be an important benefit.

Andrea Downing Peck

Related Information:

A Wearable Microneedle-Based Extended Gate Transistor for Real-Time Detection of Sodium in Interstitial Fluids

Researchers at the Technion Developed a Flexible Microneedles Platform That Provides Quick, Continuous, and Pain-Free Diagnosis

Microneedle Drug Delivery Systems Market Are Slated to Increase at Healthy 6.6% CAGR Over the Forecast Period

Transdermal Patch Continuously Monitors Blood Chemistry—Without Needles and Clinical Pathology Laboratory Testing

New blood chemistry monitoring device could replace some traditional laboratory testing

There’s a new technology that makes it possible to continuously monitor an individual’s blood chemistry and wirelessly transmit the data. This technology uses a transdermal patch and is a different approach to clinical diagnostics with the potential to supplant some traditional medical laboratory testing.

This transdermal patch was developed by Sano Intelligence, one of San Francisco-based Rock Health’s start ups for 2012. These developments were reported in a story published by Co.EXIST. (more…)

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