MACs Back Off Proposed Toxicology Cuts

MACs Back Off Proposed Toxicology Cuts

MACs Back Off Proposed Toxicology Cuts

Six Medicare Administrative Contractors (MACs) have retired
proposed Local Coverage Determinations (LCDs) that would have
limited reimbursement for definitive drug testing to no more than 14
drug classes.

The proposed LCDs would have resulted in effective Medicare reimbursement cuts of 21% for procedure code G0482 (definitive drug testing for 15-21 drug classes) and 37% for G0483 (22+ drug classes). This would have resulted in an estimated $100+ million per year of lost Medicare revenue for toxicology labs (see LE, March 2023). Additionally, due to the draft LCDs proposed reduction to the number of recognized drug classes, most testing falling under procedure code G0481 (8-14 drug classes) would have been reclassified to procedure code G0480 (1-7 drug classes), which reimburses at $114.43 vs $156.59 for G0481.

The five MACs that had proposed limiting reimbursement for definitive drug testing to no more than 14 drug classes were CGS administrators, First Coast Service Options, Noridian, Novitas Solutions, Palmetto GBA and Wisconsin Physicians Service. Another MAC, National Government Services (NGS), had actually introduced the proposed changes by issuing a billing article late last year. NGS then issued a proposed LCD for capping definitive drug testing in February 2023.

However, all of the MACs, including NGS, retired the proposed changes in early April.

The American Clinical Laboratory Assn., the big commercial labs and numerous independent toxicology labs, with bipartisan and bicameral support from Congressional representatives, had all argued to the MACs against the proposed changes. Their reasoning included:
    1) The proposed LCDs directly violated CMS’s national coding and                          payment policies for definitive drug testing.
    2) CMS had published clear guidance in 2016 that the definitive drug test           codes (G0480-G0483) and payment rates—that providers must use—             were set based on AMA CPT Manual listings of drugs and drug classes.
   3) The proposed policies could cause significant disruptions to access for            drug testing services during the ongoing opioid public health                            emergency.

“This outcome reflects the highly constructive dialog that occurred between all key stakeholders and a recognition of the importance of definitive drug testing services as a vital tool in combating
the worsening opioid epidemic,” noted Joel Galanter, Chief Legal Officer of Aegis Sciences (Nashville, TN).

Newly proposed LCDs issued by the MACs are now focused on tweaking the language that describes patient risk assessments and documentation that doctors should use before ordering drug testing. There are no drug class caps on the definitive drug test codes (G0480-G0483) contained in the newly proposed LCDs.

Aegis Sciences Leads In Toxicology Testing

Aegis Sciences Leads In Toxicology Testing

Aegis Sciences Leads In Toxicology Testing

Aegis Sciences Corp. operates the nation’s largest toxicology lab as measured by Medicare Part B carrier allowed payments for calendar year 2020 (the latest available data). Aegis received Medicare payments totaling $32.4 million for 214,348 test services for five key toxicology codes (G0480-G0483 & 80307) in 2020. The acquisition of the HealthTrackRx toxicology line of business brings Aegis additional annual Medicare payments of $2.6 million with total allowed test services of 17,716.

On a consolidated basis, Labcorp had total Medicare Part B allowed payments of $45.3 million for 378,083 test services performed at 22 lab locations.

Quest Diagnostics had total Medicare Part B allowed payments of $33.5 million for 328,888 test services performed at 28 lab locations.

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Aegis Sciences Leads In Toxicology Testing

Toxicology Labs Average $475 Per Medicare Patient

Toxicology Labs Average $475 Per Medicare Patient

.The top 25 independent toxicology lab companies received an average of $475 of revenue per Medicare patient they served in 2019, according to data analyzed by Laboratory Economics from the Medicare Part B program.

The biggest toxicology lab in the country is Aegis Sciences Corp. (Nashville, TN), which received $47.8 million of Medicare payments for 387,812 tests provided to 117,943 patients in 2019 for an average of $405 per patient. Aegis billed an average of 3.3 CPT codes per Medicare beneficiary it served. Its three highest volume codes in 2019 were G0482 (drug test, definitive; 15-21 classes), CPT 80307 (testing for presence of drug) and G0481 (drug test, definitive; 8-14 classes).

Vitas Laboratory (Barling, AR) collected the highest average Medicare payment per beneficiary at $4,459. The company billed an average of 28 CPT codes per Medicare beneficiary it served. Its three highest volume codes in 2019 were G0483 (drug test, definitive; 22+ classes), CPT 80307
and CPT 80053 (comprehensive metabolic panel). The owner of Vitas Laboratory, Billy Joe Taylor, was recently indicted for allegedly defrauding Medicare.

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Aegis Sciences Leads In Toxicology Testing

Spotlight Interview With Aegis Sciences CEO Frank Basile

Spotlight Interview With Aegis Sciences CEO Frank Basile

Aegis Sciences Corp. (Nashville, TN) performs some 20 million toxicology tests per year, making it one of the nation’s largest toxicology labs. On April
15, Aegis launched Covid-19 PCR testing with an initial capacity to perform up to 3,500 tests per day. Laboratory Economics recently spoke with Chief Executive Frank Basile, MD, to discuss Aegis and its Covid-19 testing strategy.

How many Covid-19 PCR tests is Aegis currently performing?
We are currently performing an average of about 10,000 tests per day with capacity of up to 30,000 tests per day. We’re using the PerkinElmer RNA/DNA extraction system and ThermoFisher’s QuantStudio 7 analyzer for testing.

Who are your Covid-19 clients?
We’ve added over 1,000 new clients over the past 12 weeks, including urgent care centers, surgery centers, nursing homes, doctor’s offices, correctional facilities and colleges and universities. We also have state contracts with Tennessee, Louisiana and Oklahoma. We placed a moratorium on new client starts in July in order to maintain a 24-hour turnaround time from specimen pickup to result reporting. This was recently lifted as we have increased capacity.

Are private payers matching Medicare’s reimbursement rate of $100 for Covid-19 PCR testing?

Yes, in the majority of cases. Medicaid, however, in some states is paying significantly below and/or are not credentialing because they insist on an “in-state bricks and mortar” presence which is slightly impractical during the pandemic. Additionally, certain payers are denying claims, paying the patient, or not responding at all. This is a significant problem and appears to be in direct conflict with the CARES Act.

Describe the NIH grant that Aegis was awarded and how it will be used.
Aegis has received a $6.6 million grant from the National Institutes of Health (NIH) under its Rapid Acceleration of Diagnostics (RADx) program. The grant funding will be used to expand our molecular lab from 3,000 square feet to 18,000 square feet. We’ll also be moving to Thermo Fisher’s highthroughput KingFisher Flex system for RNA/DNA extraction into the lab. We plan to increase our capacity to 60,000 Covid-19 PCR tests per day by September 30. In addition, we are developing a multiplexed Covid-19 + Flu A/B assay which will be available early October.

Any plans for pooled testing?
We have looked at it. However, we’re currently seeing positivity rates of around 10%, which makes pooled testing less feasible. Pooled testing is best suited for discrete population testing of groups expected to have positivity rates of <5%. Aegis serves clients nationwide that range from pre-surgery testing (low positivity rate) to walk-in clinics and correctional facilities (higher positivity rate). Our lab TAT averages less than 24 hours. Samples would have to be segregated to take advantage of pooled testing, leading to workflow complexity and potentially overall increases in TAT.

Has Aegis experienced any supply shortages?
Supplies haven’t been a limiting factor for us. We spent five weeks prior to launch getting our supply chain in order. For example, we diversified key supplies by validating specimen transport media from multiple vendors.
Rapidly finding and retaining good people has been the biggest challenge we have needed to overcome. Over the past 12 weeks we have hired over 200 employees, and will continue to hire more, especially for specimen accessioning and processing positions in the lab. Our current overall employee count is 1,051.

Describe your new Covid-19 antibody test.
On August 31, Aegis launched a Covid-19 antibody test that utilizes dried blood spot specimens. The test allows samples to be taken by fingerstick and should be popular for testing children and others. Samples are sent to our lab without the need for an invasive blood draw or additional processing at the collection site. We validated the test in accordance with FDA Emergency Use Authorization (EUA) requirements and it showed 99.9% specificity and 96.1% sensitivity. Demand for antibody testing has
been slow so far, but that is likely to change after a Covid-19 vaccine becomes available. Antibody testing could be used to determine if previous exposure to the virus occurred or to see if an individual that received a vaccine elicited an immune response. We expect this to become an important test later this year and into next year, especially as we bring additional product enhancements to market.

Have your toxicology test volumes bounced back from the lows?
Our toxicology volumes bottomed in mid-April but have since rebounded to approximately 80% to 85% of pre-pandemic levels. I expect we’ll be back to nearly 100% of “pre-pandemic” levels sometime by year’s end.

Do you think Covid-19 will come back in a severe way this fall/winter?
I expect cases to spike up, along with other respiratory infections, this coming fall and winter, although masking might limit the upsurge.