ACLA

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.

If the bill passes in its current form, PAMA reporting would be delayed until January 2022 and rate cuts scheduled for 2021 would be put off to 2022.

ACLA President Julie Khani emphasized that commercial labs have been performing SARS-CoV-2 testing without confirmation of payment.

The bill, which was introduced in the House and Senate, would resolve longstanding questions around the FDA's authority to regulate laboratory-developed tests.

FDA officials said at ACLA's annual meeting that the agency's efforts to balance rapid test access with safety during the coronavirus crisis carries lessons for the oversight of all tests.