Page 74 - 2020 Annual Reports Book

developers that want to market serology tests will need to submit EUA requests 10 business days from
the day they notify the agency of their marketing plans. The FDA also provided guidance on test
validation and performance expectations and made available voluntary serology test EUA application
templates.

Use Molecular, Not Antibody Tests, for Primary Diagnoses – The FDA also advised that serological
(blood) tests for SARS-CoV-2 antibodies are not intended to be used as a primary diagnosis for COVID-
19. It can take up to 14 days after the onset of symptoms for an IgG antibody to be detected by a
serology test. Serological tests may be beneficial instead to help determine who no longer is susceptible
to the infection as well as who may be a candidate for convalescent plasma donation.

Primary diagnoses should rely instead on molecular methods such as polymerase chain reaction (PCR),
which are highly specific because they are based on the unique genetic sequence of SARS-CoV-2. If a test
comes back positive, one can be confident that there was SARS-CoV-2 viral RNA in the specimen
collected from the patient. While there is still a significant risk of a false negative result with PCR
testing, the chance of a false positive is almost nil. For that reason, the molecular methods are
preferred as a primary diagnostic tool.

CMS Boosts Fees for High-Throughput COVID-19 Testing, Specimen Collection

CMS announced April 15 that is was nearly doubling the fee it pays for COVID-19 testing that uses high-
throughput technology. Starting that date, CMS will pay $100 for high-throughput COVID-19 testing (vs.
an average of $51 for traditional COVID-19 testing) until the end of the current Public Health
Emergency.

As defined by CMS, “A high throughput technology uses a platform that employs automated processing
of more than two hundred specimens a day. Examples of high throughput technology as of April 14,
2020 include but are not limited to technologies marketed on that date as the Roche cobas 6800
System, Roche cobas 8800 System, Abbott m2000 System, Hologic Panther Fusion System, GeneXpert
Infinity System, and NeuMoDx 288 Molecular.”

Earlier in April, CMS announced that it was temporarily increasing the Medicare/Medicaid specimen
collection fees as they relate to collection of certain COVID-19 testing specimens. Normally CMS pays a
$3.00 specimen collection fee for diagnostic testing samples, or $5.00 if the patient is in in a skilled
nursing facility (SNF) or served by a home health agency (HHA). Due to the special skills required to
collect Covid-19 samples, CMS increased the specimen collection fee to $23.46 generally, and $25.46 for
a patient in a SNF or collected by a laboratory on behalf of a HHA, for COVID-19 testing. This increase
applies for the duration of the Public Health Emergency. On April 30, CMS added two more HCPCS codes
to include COVID-19 specimen collection in a hospital outpatient setting and in a physician’s office.

Additionally, CMS will continue to pay an allowance for travel and expenses incurred in connection with
collecting Covid-19 test specimens from homebound patients, non-hospital inpatients, patients in SNFs,
and patients served by a home health agency. These travel allowances will be paid in accordance with
existing Medicare/Medicaid policies.

The Department of HHS also announced in April that licensed pharmacists may order and administer
FDA-approved COVID-19 tests, including serology tests. HHS issued the guidance under the Public
Readiness and Emergency Preparedness Act (PREP Act), which also shields providers from liability for all

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