Agendia CMS Compliance Policy (Date of Service)

Agendia, Inc. is committed to providing quality testing for patients and their treating physicians by offering timely results, reliable customer service, and adhering to responsible billing practices. As a part of Agendia’s regulatory policy, we follow all Federal & State requirements, based on applicable rules and regulations as it relates to Clinical Laboratory services.

What is the 14-Day Rule?

The “14 Day Rule” is a regulation set forth by the Centers for Medicare & Medicaid Services (CMS) that generally requires laboratories, including Agendia, to bill a hospital or hospital-owned facility for certain clinical and pathology laboratory services and the technical component of pathology services provided to Medicare patients when services are ordered less than 14 days after an inpatient discharge.

How do we determine the date of service?

In general, the date of service (DOS) for clinical diagnostic laboratory tests is the date of specimen collection unless the physician orders the test at least 14 days following the patient’s discharge from the hospital. In the latter situation, the DOS is the date the test is performed, instead of the date of specimen collection.

Who is impacted by the 14 Day Rule?

Hospitals and hospital-owned facilities where the patient’s specimen was collected for a hospital inpatient encounter.

Is there an exception to the Date of service (DOS) policy?

Yes, in the case of a molecular pathology test, or an Advanced Diagnostic Laboratory Test (ADLT) that meets the criteria of section 1834A(d)(5)(A) of the Social Security Act, the date of service must be the date the test was performed, only if the following conditions are met:

– The test is performed following a hospital outpatient’s discharge from the hospital outpatient department:

– The specimen was collected from a hospital outpatient during an encounter (as both are defined 42 CFR 410.2);

– It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter;

– The results of the test do not guide treatment provided during the hospital outpatient encounter; and

– The test was reasonable and medically necessary for the treatment of an illness

Below is an outline of the scenarios under which the Medicare date of service rules will apply to Agendia’s tests. The decision to submit an order for testing should be guided by the clinical judgment of the ordering physician and should not be based on the application of any billing rules.