Knowledge Base Article

Q:

What is the latest on the laboratory date of service policy?

A:

The latest news concerning the laboratory date of service policy is another extension from CMS of the enforcement discretion of the laboratory date of service exception policy until July 1, 2019. To understand this better, let’s briefly examine the lab date of service policy.

The laboratory date of service policy affects who bills Medicare directly for hospital laboratory testing – the hospital laboratory or the testing (performing) laboratory. Hospitals are required to bill Medicare directly for laboratory tests performed by an outside testing lab under arrangements on hospital inpatients and outpatients based on the following date of service rules. When the hospital bills Medicare directly, the hospital must pay the testing laboratory for performing the test(s).

1. Generally, the date of service (DOS) for clinical diagnostic laboratory tests is the date of specimen collection.
2. When a physician orders a laboratory test at least 14 days following the patient’s discharge from the hospital, the lab DOS “14-day rule” applies. This means the DOS is the date the test is performed, instead of the date of specimen collection. 
3. The lab DOS exception policy referenced above was published in the 2018 OPPS Final Rule with an effective date of January 1, 2018. The new lab DOS policy established another exception for Advanced Diagnostic Laboratory Tests (ADLTs) and molecular pathology tests excluded from OPPS packaging policy so that the DOS is the date the test was performed, if the following conditions are met.

1. The test is performed following a hospital outpatient’s discharge from the hospital outpatient department; 
2. The specimen was collected from a hospital outpatient during an encounter; 
3. It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter; 
4. The results of the test do not guide treatment provided during the hospital outpatient encounter; and
5. The test was reasonable and medically necessary for the treatment of an illness.

If all of the requirements are met, the DOS of the test must be the date the test was performed, which effectively separates the laboratory test from the hospital outpatient encounter. As a result, the laboratory performing the test must bill Medicare directly for the test, instead of seeking payment from the hospital outpatient department. The hospital laboratory must not bill Medicare directly for the test unless they actually perform the test.

Since this is a major change for hospital laboratories in how they handle billing of certain lab tests, CMS has twice delayed the enforcement of this policy to allow hospitals time to change their processes to comply with the new policy. As stated above, the latest extension of enforcement discretion was published on December 26, 2018 and announces another 6-month extension to July 1, 2019.

Hospital laboratories that are able to comply with the new laboratory DOS exception policy should do so now, and all hospital labs should comply as soon as possible. A hospital laboratory that is not able to comply with the exception policy at this time may continue to bill Medicare for the applicable tests during the extension of the enforcement discretion period. In this case, the testing laboratory would seek payment for the test from the hospital.

You can find more information about the Laboratory Date of Service Policy on CMS’s Laboratory Date of Service Policy webpage. This webpage includes the enforcement discretion announcement and associated Q&As in the Enforcement Discretion documents in the Download section at the bottom of the page.