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Medicare Billing Policy

The 14-day rule is part of CMS’ Date of Service Regulation (42 C.F.R. Section 414.510).

Exact Sciences is committed to compliance with all applicable laws, rules and regulations, including billing regulations promulgated by the Centers for Medicare and Medicaid Services (CMS). When a laboratory test such as the Oncotype DX test is ordered for a hospital inpatient within 14 days of the patient’s discharge from the hospital, CMS regulations require Exact Sciences to bill the hospital directly for that test. This rule is commonly referred to as the “14-day rule.” The 14-day rule is part of CMS’ Date of Service Regulation (42 C.F.R. Section 414.510). As of January 1, 2018, the 14-day rule does not apply to tests ordered for hospital outpatients, and Exact Sciences bills Medicare directly for such tests, regardless of their order date.

Exact Sciences processes test orders as they are received from ordering providers. Clinical judgment should be the determining factor regarding when tests are ordered and Exact Sciences does not seek to influence the timing of test orders for any given patient due to billing or other reasons.

Learn more about coverage for our tests