FDA Final LDT Rule Could be Published Soon

FDA Final LDT Rule Could be Published Soon

FDA Final LDT Rule Could be Published Soon

On March 1, the FDA submitted its final rule for LDT regulation to 
the White House’s Office of Information and Regulatory Affairs 
(OIRA). This is a perfunctory last step before the final rule is published
in the Federal Register. This could occur as soon as April 1. This will be
the most impactful new regulatory change for laboratories since PAMA
completely overhauled the Medicare CLFS in 2018.


OIRA (pronounced “oh-eye-rah”) is a statutory part of the Office of Management and Budget within the Executive Office of the President. OIRA is responsible for reviewing all federal regulations (i.e., the Executive Branch’s administrative actions) to ensure they meet all statutory requirements. OIRA is currently headed by Richard Revesz, Administrator, who was appointed by President Biden and confirmed by the U.S. Senate in late 2022.

“OIRA reviewed the proposed rule in record time, so it is reasonable to expect that the review of the final rule will not be protracted. I would not be surprised if OIRA completes its review in 30 days and FDA publishes the final rule in the federal register in the first week of April,” according to attorney Sheila Walcoff, Chief Executive at the IVD consulting firm Goldbug Strategies (Gaithersburg, MD).

Typically, a final rule will specify an effective date of 30 or 60 days after the publication date, adds Walcoff.

Once a final rule is published it will be difficult to overturn.

Last Chance to Sway OIRA Against Regulation 

OIRA staff held nine teleconferences with organizations advocating both for and against FDA LDT regulation last year. OIRA is next scheduled to meet with The Association for Diagnostics and Laboratory Medicine (ADLM — formerly AACC) on March 18. ADLM, which represents approximately 8,000 members, including clinical labs and IVD manufacturers, has steadfastly
opposed FDA regulation of LDTs. This could be the last chance that the lab industry has to sway OIRA against rubber-stamping the final rule.

Expected Legal Challenge

A final rule is almost guaranteed to trigger a lawsuit from lab trade groups, which will argue that the FDA does not have the authority to regulate LDTs.
The American Clinical Laboratory Assn. (ACLA — Washington, DC) seems to be gearing up for a lawsuit to the impending final rule. In a statement, ACLA President Susan Van Meter said:

ACLA has significant concerns about the legality and impact of FDA unilaterally imposing an ill-fitting medical device scheme on laboratory-developed testing services, which are professional services and not medical products. Should the agency promulgate a final rule, ACLA will assess its options at that time; but we continue to urge the agency to withdraw the proposed rule and reengage on advancing appropriate legislation.

Could a New Trump Administration Put the Kibosh on LDT Regulation?

As a component of OMB, OIRA is part of the Executive Office of the President and helps ensure that covered agencies’ rules reflect the President’s policies and priorities.

The FDA is moving quickly because the national election in November could result in a new administration opposed to LDT regulation. A new President could, immediately upon taking office, prevent a proposed rule from being finalized, according to long-time lab regulation expert Dennis
Weissman (Falls Church, VA).

However, Weissman says that changing or canceling a final rule is much more difficult. Once a federal rule has been finalized a new administration would be required to undergo the formal rulemaking process (i.e., opportunity for public comment on a proposal followed by final rule) to change or repeal all or part of a final rule.

In addition to this administrative action, Congress could also take legislative action to overturn a final rule, notes Weissman.


NYSCLA Meeting Highlights:PAMA, Pandemic Response, Shortages & AI

NYSCLA Meeting Highlights:
PAMA, Pandemic Response, Shortages & AI

NYSCLA Meeting Highlights:
PAMA, Pandemic Response, Shortages & AI

Following cancellation last year due to the pandemic, the New York State Clinical Laboratory Association (NYSCLA) held this year’s annual meeting in a well-spaced conference room in Albany, October 6-7. Approximately 125 lab directors, managers, pathologists and vendors were in attendance—down from the average 200+ at pre-pandemic NYSCLA meetings. Key topics discussed included the outlook for the Medicare CLFS under PAMA, the New York clinical lab response to the pandemic, workforce shortages, and the risks and ethical challenges of using artificial intelligence in healthcare. Below are brief summaries of several speaker presentations.

Alan Mertz, Director of Government Relations at NeoGenomics (Fort Myers, FL), said the lab industry, led by the American Clinical Laboratory Assn. (ACLA), is lobbying to have Medicare CLFS rates frozen for another year in 2022. This would delay scheduled Medicare rate cuts of up
to 15% for most high-volume clinical lab tests, but would not change the second PAMA private payer data reporting period for labs of January to March 2022.

Another one-year delay would give the lab industry time to try to get legislative changes to PAMA that ensure that all lab providers (independents, hospitals and POLs) are accurately represented through statistical sampling when CMS calculates new CLFS rates for 2023-2025. Other changes sought by ACLA included limiting annual CLFS rate changes to between +5% and -5% per test, increasing the length of time between each data collection period from three years to four years, and excluding Medicaid managed care rates from future surveys.

Mertz noted that ACLA’s PAMA lawsuit against HHS/CMS, initially filed in December 2017, has been going on for nearly four years. Most recently, a federal district court dismissed the lawsuit in March, ACLA filed a notice of appeal in May, and hearings are expected to begin later this year.

Separately, Mertz noted that the lab industry has been trying to get clarity from the Department of Justice on the scope of the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) for the past two years. A provision in the EKRA outlaws most traditional volume-based commissions paid to lab sales reps. EKRA was initially intended to target abusive kickback relationships between toxicology labs and addiction treatment centers. It doesn’t look like this will be enforced against legitimate labs, but a formal DOJ opinion is needed, according to Mertz.

Finally, Mertz said that ACLA is supporting the VALID Act, which would grandfather in existing laboratory-developed tests (LDTs), but require FDA regulation of new LDTs. This would be preferable to any potential FDA regulations that might be developed under the notice- and-comment
rulemaking process. Mertz believes the VALID Act has a chance to pass into law as an attachment to either a drug or medical device user fee reauthorization bill in 2022.

Brian Jackson, MD, Medical Director of Support Services, IT, and Business Development at ARUP Laboratories (Salt Lake City, UT), discussed the potential risks and ethical issues associated with using big data and AI in healthcare. Jackson noted how machine learning programs in
the past had developed biases as a result of being trained on non-diverse datasets. 

Violation of patient privacy is another risk. Jackson noted that Target and other retailers have developed algorithms so sophisticated that they can identify personal medical information based on an individual’s purchasing patterns. He cited a study that found that 99.98% of Americans could be correctly re-identified in any de-identified dataset by cross-referencing 15 demographic attributes (Nature, July 23, 2019).

Jackson warned that current FDA regulations of medical AI algorithms are too lax and require very little to achieve clearance. According to a study of 130 medical AI algorithms approved by the FDA between 2015 and 2020: 1) most were based on retrospective data only; 2) 93 out of the 130 devices had only single-site evaluation; and 3) only 17 reported that demographic subgroups were analyzed. [see Wu et al. Nature Medicine 2021;27:576-54]

Jackson urged labs to perform their own validation and quality control studies on new AI applications they deploy, just as they would when adding a new chemistry assay.

On the question of AI algorithms someday replacing pathologist interpretations, Jackson said pathologists may find themselves signing out more cases per day, but “I don’t see pathologists being
out of work any time in the near future.”

James M Crawford, MD, PhD, Senior Vice President of Laboratory Services at Northwell Health, noted that Northwell Health Laboratories (system-wide, inclusive of hospital lab-based and Core Lab-based testing, but not including rapid tests performed at Urgent Care Centers) is in the range of 5,000 to 8,000 Covid-19 PCR tests per day. Current positivity rates are hovering between 3% to 4%, according to Crawford.

Positivity rates had averaged more than 70% at Northwell Health at the peak of the pandemic in the New York City area in early April 2020. “We’ve probably never seen that high of a percentage positivity rate for any other pathogen,” noted Crawford.

He said that serological tests ordered by physicians and resulted by Northwell Health Laboratories are currently averaging about 90% positive for antibody tests for “Ig-S” (presumably a reflection of vaccination-related testing) and about 40% for antibody tests for “Ig-N” (presumably tests ordered to see whether a patient had recovered from natural infection). Crawford noted that this testing is from a population in which physicians wanted to know the test results and cannot be viewed as a “serosurvey” of the general population.

Crawford believes the New York City region will continue to see a steady rate of Covid-19 positivity, but that societal function and healthcare delivery will be relatively sturdy through the coming winter months. “Covid-19 will be with us for the foreseeable future. The key is staying committed
to our careful ways in co-existence with Covid-19.”

Carlos Cordon-Cardo, MD, PhD, Chairman, Department of Pathology, Molecular and Cell Based Medicine at Mount Sinai Health System (MSHS-New York City), described Mount Sinai’s transition to digital pathology. The timeline included the initial purchase order for Philips IntelliSite Pathology Solution in June 2019, integration of Philips-Sunquest and the MSHS LIS barcode system in late 2019, and going live for clinical diagnostics in early 2020. Labcorp, which acquired the MSHS clinical lab outreach business in 2017, helped with the digital pathology implementation. Cordon-Cardo says that MSHS pathologists are now using a combination of traditional microscope and digital pathology to interpret cases.

“Staffing has become the number one thing on everybody’s mind,” noted NYSCLA President Eloise Aita, PhD. She noted that approximately 50% of lab workforce is over the age of 55. Last year, the number of new NYS licensed clinical laboratory technologists fell by 17% to 304, while the number of new clinical lab technicians fell by 8% to 73. Challenges to attracting new workers include poor visibility of the specific occupations in the laboratory and limited job advancement opportunities, according to Aita. “The pandemic has shone a light on the importance of our industry, let’s take advantage of that.”

Tips For Negotiating Your Lab’s Next Reference Testing Contract

Tips For Negotiating Your Lab’s Next Reference Testing Contract

Tips For Negotiating Your Lab’s Next Reference Testing Contract

Reference (aka send-out) testing expenses average between 5% and 10% of the overall budget at most hospital laboratory departments. “Everybody thinks they are getting a good deal, but most have not wrung out the lowest prices available from their reference lab,” notes Steve Mattice,
President of the hospital lab consulting firm J.A. Mattice & Associates (Portland, OR). Below we highlight some of Mattice’s key tips and observations.

What’s the “hot list” in terms of send-out tests?
This is the list of 10 to 100 higher-volume send-out tests that the big reference labs (ARUP, Labcorp, Mayo and Quest Diagnostics) will discount the most in order to win a contract. But it’s a diversion because they offset their lower prices on the recognizable tests with much higher prices on lower-volume send-out tests. Each of the major reference labs is most focused on the overall profitability of their reference testing contracts.

How can hospitals negotiate for the best overall reference testing contract?
The key is knowing the lowest price that the major reference labs are willing to provide for each specific send-out test. We have helped negotiate more than 100 reference testing contracts over the past 30 years and have maintained a database of the lowest prices we have found for send-out tests from the four largest reference labs. Every time we find a lower price for the same test code, we keep track of it, and it becomes our new standard price for negotiations. When negotiating a new send-out testing contract, we will typically analyze the total annual costs for all send-out tests at a hospital client.

What kind of pricing variation is there?
There is a wide variation (see table). For example, we have found that some hospitals pay their reference lab as little as $9 for Lyme Disease Antibody tests (CPT 86618), while others pay as high as $101. It’s not like shopping at the supermarket where you can easily compare prices. In reference testing, like most of healthcare, nobody knows what the other guy is charging.

What kind of savings are you typically able to achieve?
Historically, we have averaged in the range of 23% to 27% savings for each new three-year reference testing contract. However, over the past year, labs have begun to experience inflationary pressure on wages, reagents, paper supplies, courier services, etc. As a result, we’ve started to see the big reference labs draw a harder line on pricing.

Have there been any new entrants in reference testing to challenge the “big four?”
There are a handful of large health systems and academic medical centers competing on a regional basis and Sonic Reference Laboratory has been making some inroads into the market over the past few years.

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PC Rates For Key Pathology Services To Get 12% Cut

PC Rates For Key Pathology Services To Get 12% Cut

PC Rates For Key Pathology Services To Get 12% Cut

Medicare professional component (PC) reimbursement rates for most high-volume pathology services will be cut by 12% next year, according to the newly released Proposed Medicare Physician Fee Schedule (MPFS) for 2021. For example, the 2021 Medicare rate for the PC of CPT 88305 is proposed to be cut by 12% to $34.52, while the TC will remain the same at $32.26. Overall, the proposed global rate for CPT 88305 will decline by 7% to $66.78. The reductions are the result of budget neutrality requirements that offset the cost of major rate hikes given to evaluation and management (E/M) services paid to primary care physicians.

Overall, CMS estimates that the new rates will reduce Medicare reimbursement to pathologists by 9% in 2021, while technical component reimbursement to pathology labs will fall by 5%. Among the other specialties hurt by the redistribution of funds to primary care physicians include anesthesiology (-8%), emergency medicine (-6%), general surgery (-7%), infectious disease (-4%) and radiology (-11%). Specialties benefiting include endocrinology (+17%), family practice (+13%), hematology/oncology (+14%), nurse practitioner (+8%) and rheumatology (+16%).

The global rate for CPT 88342 (IHC, first stain procedure) is proposed to decrease by 7% to $99.68; professional interpretation down 12% to $32.26; technical component down 4% to $67.42.

The global rate for CPT 88341 (IHC, additional stain) is proposed to decline by 7% to $88.07; professional interpretation down 12% to $26.13; technical component down 4% to $61.94.

Molecular Pathology
One of the few bright spots in the proposed MPFS for 2021 is a recalculation of the rate for Molecular Pathology Interpretation (HCPCS code G0452). The current rate of $19.13 is proposed to more than double to $42.91 in 2021.

The Clinical Laboratory Fee Schedule                                                            An amendment (sec. 3718) to the CARES Act has further delayed the reporting period for labs to submit their private-payer payment data to CMS for the second PAMA survey cycle. Labs are still required to collect their private payer payment data from the period Jan. 1, 2019 through June 30,
2019, but the reporting period has been delayed to the first quarter of 2022. Medicare CLFS rates will be frozen in 2021, and lab test codes will then be subject to 15% max annual cuts from 2022 through 2024. CMS plans to finalize these changes when it issues its Final MPFS Rule this fall.

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Medi-Cal Seeks Approval To Slash Lab Rates

Medi-Cal Seeks Approval To Slash Lab Rates

Medi-Cal Seeks Approval To Slash Lab Rates

California’s Department of Health Care Services (DHCS) has completed its
latest private-payer lab rate survey and is seeking federal approval to lower
Medi-Cal fee-for-service (FFS) rates for more than 60 high-volume lab and pathology services (effective retroactive to July 1, 2020 upon federal approval). DHCS estimates that the proposed rate cuts will save Medi-Cal approximately $12 million annually from the $212 million per year it currently spends on FFS payments for lab and pathology services. If finalized, Medi-Cal rates for high-volume lab and pathology codes will fall to a range of as little as 17% current Medicare rates to a maximum of no more than 80%.

California’s Medi-Cal lab fee schedule has been pegged to private-payer rates since 2015. The new proposed rates are based on DHCS’s fourth private-payer rate survey, which required approximately 300 independent labs, hospitals and pathology groups in California to submit their 10 lowest private-payer rates received in calendar year 2018 for approximately 270 high-volume lab and pathology CPT codes.

Only 132 providers actually wound up submitting their pricing data, including 14 hospital labs and 118 independent labs. DHCS has the authority to suspend providers that don’t report. However, no lab suspensions have occurred to date.

DHCS took the submitted private-payer pricing data, threw out any rates higher than 80% of the current national Medicare rates, and then calculated its proposed Medi-Cal rates based on a weighted average of the remaining private-payer survey data.

The most severe rate reductions that will occur as a result of the latest survey include an 80% reduction in the Medi-Cal rate for CPT 84402 (Free Testosterone) to a proposed rate of $4.45. If finalized at $4.45, then Medi-Cal will be paying a rate equivalent to only 17% of the current Medicare rate of $25.47 for CPT 84402. This proposed rate is so low that it suggests a calculation error, notes Laboratory Economics.

Other codes with proposed Medi-Cal rate reductions so extreme that they may be erroneous include 84681 (C-Peptide), equivalent to 22% of Medicare; CPT 88307 (Surgical pathology-Level V), equivalent to 27%; and 88312 (Special Stains Group 1), equivalent to 25%.

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California Clinical Lab Assn. Seeks Elimination of 80% Cap
In a letter to DHCS, the California Clinical Laboratory Association (CCLA) said that now is not the time to be substantially lowering reimbursements to labs which are playing a critical role in the fight against Covid-19. CCLA is supporting a bill (AB 1327) from California Assemblywoman Cottie Petrie-Norris that would eliminate the 80% of Medicare cap on Medi-Cal FFS rates for lab and pathology services. This bill was first introduced in February 2019.

CCLA attorney Kristian Foy says that there is no justification for the 80% cap given that Medicare CLFS tests were reduced by 10% per year between 2018 and 2020 under PAMA. Removal of the cap might allow Medi-Cal rates for some lab and pathology test codes to rise to up to 100% of current Medicare rates. Foy says that the 80% Medicare cap applied to California’s pricing data survey is undermining the purpose behind developing Medi-Cal’s California-specific market-based rates.

Furthermore, Quest Diagnostics, which is the biggest Medi-Cal lab provider (see page 4), has argued that national Medicare rates should not dictate rates in California because the implementation of PAMA relied on flawed and incomplete survey data. Other organizations supporting the Petrie-Norris bill include the California Association of Public Health Lab Directors, California Medical Association, LabCorp and Planned Parenthood Affiliates of California.

Finally, CCLA is also asking that the Assembly Bill 97 (AB 97) 10% reduction to Medi-Cal lab and pathology rates be eliminated. The AB 97 10% payment reduction, which applies to most Medi-Cal providers, was enacted during the California’s budget crisis of 2011 and has no sunset date.

A decision from CMS on the current proposed Medi-Cal lab and pathology rates is expected soon. The next DHCS private-payer data survey is scheduled to occur in 2022, and will be used to establish the July 1, 2023, Medi-Cal lab and pathology rates.

Meanwhile, Medi-Cal’s transition to using private-payer lab rates has helped it reduce its expenditures on lab testing for its two million fee-for-service (FFS) members from $314 million in 2012 to $212 million in 2019. Medi-Cal lab expenditures have also been tempered by a steady movement toward Medi-Cal managed care plans. Managed care plans are paid on a capitated basis, and they manage member care and negotiate and establish their own rates with their contracted providers. There are currently 10.3 million Medi-Cal members covered by managed care plans.

Medi-Cal Rates for Covid-19 Testing
Medi-Cal reimbursement rates for the new Covid-19 testing codes, including diagnostic testing (U0003 and U0004) and antibody testing (86328 and 86769), has been established at 100% of corresponding Medicare rates. In addition, the AB 97 10% reduction has been waived for the duration of the coronavirus crisis. Upon expiration of the public health emergency or national emergency, Medi-Cal rates for these codes will be lowered to 80% of Medicare and the AB 97 10% reduction will be applied.

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Top 20 Medi-Cal Laboratories
The largest Medi-Cal lab provider is Quest Diagnostics, which received $32.5 million of Medi-Cal FFS payments in 2019, up 10.3% from $29.4 million in 2018, according to data from DHCS.

Planned Parenthood, which tests for sexually transmitted diseases, received $29.6 million, up 19.8% from $24.7 million in 2018.

The Genetic Disease Screening Program (GDSP) of the California Department of Health is the third largest, with $27.6 million, down 6.5% from $29.5 million in 2018.

The Genetic Disease Screening Program provides prenatal and newborn testing services to Medi-Cal recipients.

LabCorp received $10.3 million of Medi-Cal payments in 2019, up 16.6% from $8.8 million in 2018.

The fastest-growing laboratory was Regents of the University of CA (aka UCLA Outreach Lab), where Medi-Cal payments jumped by 180% to $3.5 million in 2019. In total, the top 20 lab organizations collected $135.1 million of Medi-Cal lab test payments for FFS patients in 2019, up 6.7% from $126.6 million in 2018.

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Medicare Sets Good Rates For Covid-19 Testing

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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