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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

Scanadu is Preparing Consumer Self-Test Device for Review by the FDA as Part of Its Mission to Enable Patients to Monitor Their Health without the Need for Clinical Pathology Laboratory Tests

Scanadu’s device is called the ScanaFlo and is designed to collect biometric data from consumers using a variety of methods, including urine specimens

Now gathering study data needed to launch a review by the Food and Drug Administration (FDA) is a low-cost lab urinalysis device that returns results via a smartphone for conditions such as pregnancy and diabetes. More significant for pathologists and clinical laboratory executives, this handy point-of-care device is capable of doing tests for traditional medical laboratory tests, ranging from glucose and leukocytes to bilirubin and creatinine.

The device was invented at Scanadu, Inc., a health-tech startup based at NASA Ames Research Center in Mountain View, California. It is a new low-cost lab urinalysis kit that uses a smartphone to return test results on liver, kidneys, urinary tract, and metabolic functions. The company uses imaging and sound analysis, molecular diagnostics, data analytics, and a suite of algorithms to create devices that offer consumers comprehensive, real-time health data on mobile devices. (more…)

New iPhone App Allows Consumers to Test Their Urine on the Go for as Many as 25 Different Diseases

Pathologists and clinical laboratory managers may want to learn more about the UCheck mobile app developed by Biosense Technologies  

Developers of a new iPhone application claim their app can analyze a urine specimen for up to 25 different diseases. This mobile app is a deliberate attempt to give consumers the ability to perform diagnostic tests that would normally be run in a full-scale clinical laboratory.

Pathologists and clinical biochemists will want to visit the website of Biosense Technologies to check out this mobile application, which is called uCheck. Biosense is a medical device company located in Mumbai, India. (more…)

Laboratory Transforms Manual Urinalysis with Automation and More

Pre-analytical products, automated systems, and Lean Six Sigma combined to improve outcomes

In today’s era of automation and Lean Six Sigma processes in laboratory medicine, the manual urinalysis test may be ready for a major makeover. Such a development would be welcome because, in the typical American hospital, the clinical laboratory performs an average of 120 urinalyses per day.

Some clinical laboratory managers consider it counterintuitive that—during a period of automation and implementation of Lean Six Sigma processes—a diagnostic tool as important and ubiquitous as urinalysis would not be perfectly methodized. But that is frequently the case. In many clinical laboratories, the processes utilized for this line of lab tests are often outmoded, inefficient, and can even lead to erroneous results.

(more…)

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