Hospital Labs Expanding PCR-Based Test Menus

by Jondavid Klipp | Jun 23, 2023 | Covid Testing, COVID-19, PCR Testing

Hospital Labs Expanding PCR-Based Test Menus

PCR-based testing for gastrointestinal profiles, gonorrhea/ chlamydia, bacterial vaginosis panels, and herpes simplex virus (HSV) are the tests that most hospital labs plan to add to their test menus within the next 12 months, according to LE’s Hospital Laboratory Survey. These choices are obviously related to the need to find work for excess PCR testing capacity due to the wind down of the pandemic.

Twelve surveyed hospitals labs (or 8%) said they plan to add gastrointestinal panel testing by PCR. The majority of these labs specifically mentioned the BioFire GI Panel for 22 of the most common pathogens associated with gastroenteritis.

Another nine surveyed hospital labs (or 6%) cited plans to add PCR testing for gonorrhea/chlamydia (CPT 87591 & 87491).

Seven hospital labs (or 5%) indicated they will add PCR testing for vaginitis panels (CPT 87798). Most indicated their panel will include three tests: bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

Among the non-PCR tests that hospital labs plan to insource were procalcitonin (CPT 84145), free testosterone (CPT 84402), tuberculosis (CPT 86480) and Lyme disease antibody (CPT86618).

Did Digital Pathology Utilization Increase During The Pandemic?

by Jondavid Klipp | Nov 18, 2022 | Covid Testing, COVID-19, Digital Pathology, Medicare

Did Digital Pathology Utilization Increase During The Pandemic?

The conventional wisdom says that digital pathology use surged as a result of the pandemic. However, Medicare data for CPT 88361 (computer-assisted IHC for breast cancer) tells a different story. The volume of Medicare Part B allowed claims for 88361 declined by 16% to 160,819 in 2020, followed by only a 3% rebound to 165,231 in 2021. CPT 88361 is the only code devoted specifically to bill Medicare for reading digitized slides. It therefore gives an indication of digital pathology trends in the clinical market.

Another indication that the digital pathology market has not taken off during the pandemic is the falling number of pathologists using it. A total of 736 pathologists billed Medicare for CPT 88361 in 2020 (the latest year of available data), which was down from 871 pathologists in 2019. The number of independent labs billing Medicare for CPT 88361 declined from 96 labs in 2013 to 66 labs in 2019 but increased slightly to 69 labs in 2020.

The main barrier, irrespective of the pandemic, to more widespread adoption of digital pathology has been the added expense of digitizing slides without reimbursement. The problem is that digital pathology comes as an “add on” process that is produced from a traditional glass slide. Digital pathology does not eliminate the need to process, section, glass-slide-mount and stain biopsy specimens. A high-end conventional microscope costs between $9,000 and $12,000, while a complete digital pathology
system can cost between $100,000 and $400,000.

In addition, pathologist practice patterns are hard to change, especially without a clear clinical benefit and/or compelling financial incentive.

Artificial intelligence could be the game changer that jumpstarts the digital pathology market. AI-based decision-support tools that boost pathologist productivity and reduce errors need digitized images to read. AI vendors (PathAI, Paige, Ibex Medical Analytics, etc.) claim their software can help pathologists read 30+% more slides per day. This may provide hospitals and labs with the return on investment necessary to justify an investment in digital pathology scanners.

Volume Surge Expected For High-Priced Covid-19 Test Panels

by Jondavid Klipp | Nov 15, 2020 | Covid Testing, COVID-19, XIFIN

Volume Surge Expected For High-Priced Covid-19 Test Panels

With the flu season underway, more test panels are becoming available that test for Covid-19 plus other respiratory viruses, including influenza A/B and respiratory syncytial virus (RSV). Labs have begun to submit the combo PCR tests codes for Covid-19, although volume is nominal at this stage, notes Lale White, Chief Executive at XIFIN Inc. (San Diego, CA).

The AMA has issued new CPT codes for Covid-19 PCR-based test panels (87636 & 87637) and Medicare contractors have set rates for both of these codes at $142.63 by crosswalking to the existing code 87631 (respiratory virus detection, 3-5 targets).

In addition, several Proprietary Laboratory Analyses (PLA) codes (e.g., 0223U, 0202U and 0225U) have been issued for larger Covid-19 test panels that include up to 22 pathogen targets. Medicare contractors have set rates for these codes at $416.78 by crosswalking to the existing code
87507 (infectious agent detection, 12-25 targets).

There are currently an average of 1.5 million Covid-19 PCR tests being performed each day in the United States at cost of roughly $150 million per day, or $50+ billion annualized. A transition toward combo test panels reimbursed at $142-$417 per panel could potentially push the annualized market to more than $100 billion. That would exceed the total U.S. market for all non-Covid clinical lab and pathology testing.

In June 2020, the Office of Inspector General (OIG) communicated its fear that many labs are performing medically unnecessary add-on tests when responding to orders for Covid-19. The OIG has added an analysis for potential fraud and abuse with Covid-19 add-on testing to its work plan,
notes Charles Root, PhD, President of CodeMap LLC.

Top 25 Fastest-Growing Labs by Medicare Part B Volume of Services

Survey Reveals Huge Gap Between “Have” and “Have Not” Labs

by Jondavid Klipp | Oct 15, 2020 | Covid Testing, COVID-19, PCR Testing

Survey Reveals Huge Gap Between “Have” and “Have Not” Labs

The latest Laboratory Economics Covid-19 Survey of Labs showed that 71% of labs were currently performing Covid-19 PCR testing and another 3% planned to soon add this capability, while 26% were not doing this testing. Those labs that are performing Covid-19 PCR testing reported that they expect their overall test volume (including both Covid and non-Covid testing) this year to increase by an average of 59% with a median of 10%.

The benefits garnered by labs doing Covid-19 PCR testing will soon be enlarged as many labs are in the process of switching to combo tests that detect Covid-19 and influenza A/B from a single patient specimen (CPT 87636). New combo PCR tests for Covid-19, influenza A/B and respiratory syncytial virus (RSV) are also being introduced (CPT 87637).

Meanwhile, the “Have Nots” that do not perform Covid-19 PCR testing are expecting average volume growth of only 1% with a median of 0%. The “Have Nots” surveyed were comprised entirely of local pathology groups and physician-office-based labs.

“The downturn in patient office visits has decreased lab volumes and caused many to furlough or completely lay off certain areas of staff. The labs that are thriving are those that have been fast and flexible enough to add Covid testing,” said a surveyed lab executive from Florida.

“The Covid pandemic has introduced new healthcare delivery platforms, such as telemedicine, that do not enable the same amount of referral laboratory testing. Despite offering an electronic order and convenient online scheduling at local patient service centers, we are seeing an increase in patient no-shows and test orders are not being completed,” noted a lab executive from Texas.

National Covid-19 PCR test volumes have quadrupled since LE’s initial Covid-19 survey conducted back in early May. Volumes might be even higher if not for continued supply shortages. Our most recent survey
showed that 59% of labs had shortages in PCR-based Covid-19 test kits. Pipette tips (45%) and collection swabs/specimen transport media (41%) are also currently in short supply.

The Laboratory Economics Covid-19 Survey of Labs was emailed to approximately 6,000 pathologists, laboratory directors, managers and executives between September 30 and October 13. We received complete responses from 124 individuals, including 44% from local independent pathology groups/labs, 25% from national pathology/commercial lab companies, 23% from hospital-based labs and pathology groups, 6% from academic medical centers, and 2% from physician office labs.

Majority Of NYC Nursing Home Employees Have Had Covid-19

by Jondavid Klipp | Jul 15, 2020 | BioReference Labs, Covid Testing, COVID-19

Majority Of NYC Nursing Home Employees Have Had Covid-19

BioReference Labs reports that Covid-19 antibody testing it performed on nursing home employees throughout New York State in May-June showed a 29% positivity rate. New York City nursing home employees were found to have the highest positivity rate (55%).

During the same time period, BioReference performed PCR-based molecular tests for active Covid-19 infection and found a 2.9% positive rate throughout the state, including a 4.6% positive rate for New York City nursing home employees.

The testing was performed as a result of a New York State mandate (effective May 10) that all personnel at nursing home and adult care facilities be tested for active Covid-19 infection using PCR-based molecular testing, twice per week. In addition, at the start of the program, many nursing homes asked that employees be tested for antibodies at the same time.

BioReference uses the Roche Elecsys Anti-Sars CoV-2 assay for antibody testing. Overall, BioReference tested 3,488 nursing home employees in New York State (primarily in May) for antibodies and found 1,010 positive cases. “With 29% of employees testing positive for antibodies, an extrapolated estimate for the 140,000 total nursing home staff in New York State suggests as many as 41,760 nursing home staff members in the state could have had Covid-19 prior to early May,” according to Jon Cohen, MD, Executive Chairman at BioReference.

Encouraging News From Initial Covid-19 Prevalence Studies

by Jondavid Klipp | Apr 20, 2020 | Covid Testing, COVID-19

Encouraging News From Initial Covid-19 Prevalence Studies

Preliminary results from a growing number of antibody prevalence studies indicate that the Covid-19 virus has spread more widely and has a lower fatality rate than previously expected.

Stanford University School of Medicine

Between 48,000 and 81,000 residents in northern California had been infected by Covid-19 as of April 1. This is more than 50 times higher than the official count at the time of 956 cases, according to a prevalence study conducted by researchers at the Stanford University School of Medicine. The Stanford study was based on 3,300 blood samples that were taken from volunteers in Santa Clara County in early April and tested for antibodies to Covid-19. Based on 100 estimated Covid-19 deaths in the county and 48,000-81,000 cases, the Stanford researchers estimate an infection fatality rate of between 0.1% and 0.2%. The Stanford research team is conducting similar antibody prevalence studies in Los Angeles County as well as a national study of 10,000 athletes and employees from 27 Major League Baseball teams. “We’re hoping that once we get accurate numbers in place, we’ll be able to quell the fear that’s out there,” said Jay Bhattacharya, who holds an MD and PhD in economics from Stanford University.

Massachusetts General Hospital

Pathologists with Massachusetts General Hospital have found that Covid-19 is far more widespread than the official case count in the Boston area. MGH set up a testing tent in the middle of Bellingham Square in Chelsea, MA, in mid-April and took finger-prick blood samples from 200 healthy-looking residents. Samples were tested using a ten-minute rapid test made by BioMedomics. The device hasn’t yet been approved by the FDA, but MGH has validated the test. The researchers found that one third of study participants (64 people) had Covid-19 antibodies. “The bad news is that there’s a raging epidemic in Chelsea, and many people walking on the street don’t know that they’re carrying the virus, according to John Iafrate, MD, PhD, Vice Chairman of MGH’s pathology department and the study’s principal investigator. “On the good-news side, it suggests that Chelsea has made its way through a good part of the epidemic.”

University of Bonn

Preliminary results from a study focused on a small German town named Gangelt indicate that about 15% of its population has been infected Covid-19. Located near the border with the Netherlands, Gangelt has been dubbed “Germany’s Wuhan” because it was hard hit by Covid-19 after a February 15 carnival celebration drew thousands to the town (population: 12,529). In early April, researchers from the University of Bonn performed antibody testing on 1,000 people from the town and found that 15% of the population had been infected and the process towards herd immunity is already taking place. The mortality rate among the studied population was 0.37%, five times lower than that currently registered in Germany, which corroborates the suspicions that the number of infected is much higher than the diagnosed. “It is important to obtain this data in order to make sure that decisions are taken based on facts rather than assumptions,” according to Hendrik Streeck, MD, PhD, Head of the Institute of Virology and Institute for HIV Research, University Hospital Bonn.