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The president-elect's plan would provide funding to purchase rapid tests and investments to expand lab capacity.
Test capacity, particularly for rapid antigen testing, is set to explode in Q1 2021, but home and asymptomatic assays remain few and far between.
The instructions reverse an FDA decision to stop reviewing LDTs, but questions remain about how broadly they will be applied and how they will be implemented.
The COVID-19 pandemic is the highest priority for most, but laboratory organizations are also looking ahead with longer-term goals for the new presidency.
CMS will now only reimburse labs performing high-throughput COVID-19 testing at the highest payment rate if they complete testing within two days of specimen collection.
Saying pooled testing for coronavirus was not for diagnostic purposes, Cigna had said it wouldn't reimburse for the method, but it plans to change its policy.
The letter calls for expanded access to COVID-testing for everyone regardless of insurance coverage or reason for receiving the test.
The lawmakers requested the secretary to direct money from the Public Health and Social Services Emergency Fund to support clinical labs.
Some of the additional data required includes the patient's age, race, ethnicity, sex, and residence zip code, along with info about the ordering provider.
The reimbursement rates for the most commonly performed SARS-CoV-2 serologic tests are $42.13 and $45.23, depending on the billing code used.