Dear Ms. Blackford:
On behalf of the organizations listed below, which represent the major clinical laboratory stakeholders involved with testing for COVID-19, we are writing in response to the Preliminary Determinations for the above-referenced HCPCS codes for the CY 2021 Clinical Laboratory Fee Schedule (CLFS). In the Preliminary Determinations, the Centers for Medicare & Medicaid Services (CMS) has proposed to set the CLFS rates for these six COVID-19 in CY2021 using the gapfill process. For the reasons specified below, we strongly urge CMS to assign rates for these codes using crosswalk rather than gapfill for CY2021, and we offer specific crosswalks that we believe best reflect the resources required to develop and furnish these tests.
Below is a list of the codes, the descriptors, the CMS Preliminary Determination, and the stakeholder consensus recommendations:
Code |
New Code Descriptor | CMS Prelim Rec | Stakeholder Crosswalk Recommendation |
||
Code | Crosswalk Code Descriptor | Rate | |||
U0002 |
2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC |
gapfill |
87502 | Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, for multiple types or sub-types, includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, first 2 types or subtypes | $95.80 |
U0003 |
Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R | gapfill | 87502 | Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, for multiple types or sub-types, includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, first 2 types or subtypes | $95.80 |
U0004 |
2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R | gapfill | 87502 | Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, for multiple types or sub-types, includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, first 2 types or subtypes | $95.80 |
87635 |
Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique | gapfill | 87502 | Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, for multiple types or sub-types, includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, first 2 types or subtypes | $95.80 |
86328 | Immunoassay for infectious agent antibody, qualitative or semiquantitative, single step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) | gapfill | 2.5*86318 | Immunoassay for infectious agent antibody, qualitative or semiquantitative, single step method (eg, reagent strip) | $45.23 |
86769 | Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) | gapfill | 2.5*86318 | Immunoassay for infectious agent antibody, qualitative or semiquantitative, single step method (eg, reagent strip) |
$45.23 |
The laboratory stakeholders strongly urge CMS to adopt rates for the COVID-19 tests through crosswalk rather than gapfill because there are appropriate crosswalks to substantially similar tests that will establish rates appropriate to cover the resources required for COVID-19 detection tests and will incentivize appropriate testing. Establishing rates through crosswalk rather than gapfill will facilitate medically necessary testing. By contrast, gapfill leads to uncertainty about payment for a substantial part of the gapfill year. Preliminary rates not announced till nearly half-way through the year; final rates not announced till nearly the end of the year. Moreover, gapfill leads to different rates across the country, which risks differential access to testing if rates are inadequate in some regions. Therefore, the stakeholders strongly urge CMS to adopt CY2021 CLFS rates for the six codes using the crosswalk—rather than gapfill—process.
The specific crosswalks recommended by the stakeholders reflect the significant resources required to develop and furnish COVID-19 tests. Clinical laboratories and manufacturers rose to meet the needs of the healthcare community by investing substantial resources rapidly to develop tests for SARS-CoV-2. The development of these tests involved substantial costs, including:
Several of the stakeholders listed below previously submitted proprietary cost information to CMS and the MACs to quantify some of the costs associated with the factors above in order to support the differential costs of COVID-19 testing compared to other microbiology and immunology tests that otherwise may seem methodologically similar but which do not involve these extraordinary costs incurred due to the PHE.
In addition to the substantial development costs, ongoing operational costs for COVID-19 testing include the following:
In conclusion, test developers invested significant resources and set aside important projects to assist to develop COVID-19 testing in response to the COVD-19 pandemic. Clinical laboratories performing these tests continue to incur extraordinary costs in furnishing these tests—costs that are substantially in excess of costs incurred when performing amplified probe testing for a single type or subtype of influenza. These test developers have been acting under the hope that CMS would establish appropriate and fair reimbursement for this testing. Therefore, we strongly urge CMS to establish rates for the six COVID-19 tests listed above by crosswalk to the codes shown above consistent with the recommendations made by the stakeholders at the Public Meeting and the extraordinary resources required to develop these tests and required to continue to offer these tests to Medicare beneficiaries. We also ask that CMS consider the precedent of its decision for future public health emergencies when test developers must act with uncertainty regarding future payment.
Sincerely,
AdvaMedDx
American Association for Clinical Chemistry
American Clinical Laboratory Association
American Society for Clinical Pathology
American Society for Microbiology
Association for Molecular Pathology
College of American Pathologists
Point of Care Testing Association