New Lab Formations Continue To Boom

New Lab Formations Continue To Boom

New Lab Formations Continue To Boom

The extraordinary demand for Covid-19 PCR, antigen and antibody testing continues to fuel a record number of new CLIA-certified lab formations, according to the latest CMS data analyzed by Laboratory Economics. More than 7,000 new CLIA lab certificates were issued in the second quarter (April 1-June 30, 2021). The all-time high (12,000+ new CLIA labs) occurred in the fourth quarter of 2020. The boom has created a huge demand for lab workers that had already been in short supply before the pandemic. 

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

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

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

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

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

Majority Of NYC Nursing Home Employees Have Had 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.

Top 25 Fastest-Growing Labs by Medicare Part B Volume of Services
Sweden’s Controversial Covid-19 Strategy

Sweden’s Controversial Covid-19 Strategy

Sweden’s Controversial Covid-19 Strategy

Sweden never imposed a strict lockdown to combat Covid-19, unlike most other countries. The only official rules put in place are a ban on gatherings of 50 people or more and a ban on visitors to nursing homes.

The nation’s Chief Epidemiologist, Anders Tegnell, MD, PhD, says Sweden’s strategy is based on the assumption that Covid-19 isn’t going away any time soon, and that severe lockdowns can’t be maintained for very long and will prove to be ineffective over the long run. Strict lockdowns may temporarily contain the virus, but won’t prevent it from returning, according to Tegnell.

In an interview with Swedish Public Radio on June 24, Tegnell said that Sweden has followed the “classic pandemic model” that he had been discussing with international colleagues for 20 years. Tegnell characterized lockdowns as flying in the face of what is known about handling viral outbreaks. “It was as if the world had gone mad, and everything we had discussed was forgotten….The cases became too many and the political pressure got too strong. And then Sweden stood there rather alone.”

Sweden, which has a population of 10.1 million, has recorded 65,137 cases, 2,407 intensive care admissions and 5,268 deaths from Covid-19 as of June 25, according to the Public Health Agency for Sweden. More than half of the Covid-19 deaths in Sweden have occurred among its nursing home residents.

Covid-19 deaths in Sweden are much higher per capita than its nearest neighbors (Finland, Norway and Denmark), which had strict lockdowns. However, its per capita death rate is lower than some other European countries that had strict lockdowns, such as Belgium, Britain, Spain and Italy.

Sweden New Covid-19 Cases 7 day moving avg
Swedish Covid-19 ICU-Admissions
Daily Deaths Covid-19 Sweden

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

Medicare Sets Good Rates For Covid-19 Testing

Medicare Sets Good Rates For Covid-19 Testing

CMS has been very fair when establishing reimbursement rates for Covid-19
tests in an effort to encourage widespread diagnostic and antibody testing.
Furthermore, private health plans are required to cover both diagnostic and antibody testing without member cost-sharing (copays or deductibles) as a result of the Families First Coronavirus Response Act (FFCRA). “Most private insurers have been uncharacteristically reasonable in establishing their rates and working with labs to fix claims processing errors for Covid-19 testing,” notes Lale White, Chairman & CEO at XIFIN Inc. (San Diego).

High-Throughput Covid-19 Diagnostic Testing
Covid-19 diagnostic testing on high-throughput testing systems (200+ specimens per day; e.g., Roche cobas 6800/8800, Abbott m2000 System, Hologic Panther Fusion System, et al.) is billed using HCPCS U0003 or U0004 at a Medicare rate of $100. XIFIN’s White says that her firm has
seen 89% of private insurance claims for U0003 and U0004 paid at or above Medicare’s rate, and only 11% underpaid. She says that underpayment most commonly occurs with BCBS plans, which are frequently paying for high-throughput Covid-19 testing at the low-throughput rate of $51.

Low-Throughput Covid-19 Diagnostic Testing
CMS has established two codes (HCPCS U0002 and CPT 87635) for low-throughput Covid-19 diagnostic testing systems (<200 specimens per day) and set reimbursement at $51.31. Aetna and Cigna are paying equivalent rates, according to Scott Liff, President & CEO at Kellison & Company (Cleveland, OH). Similarly, UnitedHealthcare and many BCBS plans are allowing $51.31, according to Deb Larson, Executive Vice President at TELCOR Inc. (Lincoln, NE). In addition, several big state Medicaid plans, including California, Illinois and New York, have set their fee-for-service rates for U0002/87635 equivalent to Medicare.

Covid-19 Antibody Testing
Medicare reimbursement for Covid-19 antibody testing has been set at $45.23 for CPT 86328 (point-of-care tests) and $42.13 for CPT 86769 (laboratory-based multi-step methods). These are very favorable rates when compared with other antibody test codes for infectious agents that are
reimbursed by Medicare at rates between $8.93 and $19.35, according to Charles Root, PhD, President of CodeMap LLC (Chicago). He notes that labs testing for two antibodies (IgM and IgG) can bill CPT 86769 twice for total Medicare reimbursement of $84.26.

Unfortunately, White says that private insurer reimbursement of Covid-19 antibody testing is more problematic. Most private payer claims for CPT 86769 are being reimbursed below the Medicare rate. For example, some BCBS plans are paying between $12 and $35, with an average of roughly $20, according to White. Similarly, TELCOR’s Larson has seen BCBS rates in the range of $12 to $20, while Kellison’s Liff has seen rates of between $15 and $18 from Cigna.

In addition, some private insurers have taken the position that antibody testing should not be covered if it’s part of an employer-based testing effort for bringing their staff safely back to work, even if the testing is voluntary and performed under a doctor’s order. This flies in the face of the CARES Act, which is intended to promote both Covid-19 diagnostic and antibody testing for anyone that wants it, notes White.

Claims Denial Rates for Covid-19 Testing
Early on in the pandemic (March/April), White says that XIFIN was seeing denials and balance bill errors occurring on about 22% of the Covid-19 test claims it processed. The most common denial and adjudication errors involved medical necessity denials and improper processing of patient
co-pays and deductibles.

However, White says that most payers have readily acknowledged their adjudication errors, made corrections and reprocessed claims with very few requesting a resubmission.

On current claims through the end of May, White says that initial denial rates have fallen to 7% with co-pay/deductible errors at less than 1%. “We expect that 7% medical necessity denial rate to get down to 4% to 5% after we make some calls to correct the remaining denial adjudication errors.”

Similarly, Larson says that TELCOR is currently seeing initial denial rates of 5% to 9% on Covid-19 test claims with the primary source of denials related to member insurance coverage eligibility.

Challenges for Out-of-Network Labs
White notes that one issue that has not been resolved is the continuation of BCBS payer policies that reimburse patients directly for out-of-network (OON) lab test claims. This forces OON labs performing Covid-19 testing to seek payment from patients. “With bad debt rates as high as 50% on direct patient billing and all the added costs involved with identifying a direct patient payment, it is not prudent for the Blues to take a position of penalizing labs that are OON during a time when extensive testing capacity is being demanded at the federal, state and local level for management of the pandemic,” observes White.

Specimen Collection Rates for Covid-19
On March 30, CMS announced the creation of new Covid-19 specimen collection HCPCS codes (G2023 and G2024) at very favorable rates.

HCPCS G2023 is intended for independent labs that collect Covid-19 specimens (by any specimen source) from homebound or non-hospital patients. Medicare reimbursement has been set at $23.46.

HCPCS G2024 is intended for independent labs that collect Covid-19 specimens (by any specimen source) from patients in a nursing home or on behalf of a home health agency. Medicare reimbursement has been set at $25.46.

CMS says that these new specimen collection codes will remain in effect until it has determined that the Covid-19 pandemic is over.

The rates for G2023 and G2024 are far above Medicare’s existing $5 rate for G0471 paid to labs for non-Covid-19 blood collection services provided to nursing home patients or on behalf of a home health agency.

However, the catch is that nearly all Covid-19 diagnostic test samples are nasal swabs that are collected by nurses, not lab-employed phlebotomists (see page 6 for more).

The new Covid-19 specimen collection codes do apply to lab-employed phlebotomists that collect blood samples for Covid-19 antibody testing from nursing home or homebound patients. However, demand for antibody testing has been weak to date.

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