Company: VCYT
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001384101-25-000014
Chunk: 81

Company: VERACYTE, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 81
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 collect cash and be paid.

Billing for clinical laboratory testing services is complex, time-consuming and expensive. Depending on the billing arrangement and applicable law, we bill various payers, including Medicare, commercial insurance companies and patients, all of which have different billing requirements. We generally bill third-party payers for our diagnostic tests and pursue reimbursement on a case-by-case basis where pricing contracts are not in place. To the extent laws or contracts require us to bill patient co-payments or co-insurance, we must also comply with these requirements. We may also face increased risk in our collection efforts, including potential write-offs of accounts receivable and long collection cycles, which could adversely affect our business, results of operations and financial condition including cash collections. Furthermore, third-party payers may reduce or refuse to pay for our tests, with or without notice. 

Several factors make the billing process complex, including:

•differences between the list price for our tests and the reimbursement rates of payers;

•compliance with complex federal and state regulations related to billing government payers, such as Medicare and Medicaid, including requirements to have an active CLIA certificate;

•risk of government audits related to billing Medicare and other government payers;

•disputes among payers as to which party is responsible for payment;

•differences in coverage and in information and billing requirements among payers, including the need for prior authorization and/or advanced notification;

•the effect of patient co-payments or co-insurance;

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•individual payers may argue technical contract noncompliance and withhold payment; 

•challenges obtaining medical records from the ordering providers;

•changes to billing codes used for our tests;

•incorrect or missing billing information; and

•the resources required to manage the billing and claims appeals process.

We use standard industry billing codes, known as CPT codes, to bill for our tests, including cytopathology. Effective January 1, 2021, we began using the new CPT code 81546 to bill for our Afirma classifier. Effective January 1, 2020, we began using CPT code 81542 to bill for Decipher Prostate tests. Effective January 1, 2021, we began using the new CPT code 81554 to bill for our Envisia classifier. Effective October 1, 2020, we began using CPT code 0016M to bill for our Decipher Bladder test. See “We depend on a few payers for a significant portion