Overview

Based on the updated CMS policy: In 2018, the Centers of Medicare and Medicaid Services (CMS) issued an update to its laboratory Date of Service Policy regarding outpatient testing sent to reference laboratories for molecular pathology tests.

• If you have already implemented: You may continue to follow your new processes.
• If you are in the process of implementation: You may continue to implement according to your existing project schedule.
• To initiate the onboarding process of Medicare billing for this type of testing referred to Mayo Clinic Laboratories (MCL): please contact the MCL Business Office at 800-447-6424 between 7 a.m. and 5 p.m. CT.

How This Affects Your Laboratory

Based on new guidance from CMS, if your organization refers outpatient testing to Mayo Clinic Laboratories (MCL) for molecular pathology tests, the performing laboratory will be required to bill Medicare directly for tests that meet specific requirements. This new exception to the laboratory Date of Service (DOS) policy will not apply to advanced laboratory diagnostic tests (ADLTs) or molecular pathology tests performed on a specimen collected from a hospital inpatient.

What You Need to Do to Begin the Process

To initiate the on-boarding process of Medicare billing for this type of testing referred to MCL, please contact the MCL Business Office at 800-447-6424 between 7 a.m. and 5 p.m. CT. An MCL client representative will discuss with you the process and necessary documents to ensure Medicare billing.

What Will MCL Need from You?

For this subset of testing/patient type (Medicare/hospital outpatients), if your organization does not request MCL to bill, Medicare will not reimburse the tests. MCL will be requesting that your organization inform us of the appropriate patient orders that meet the Medicare criteria.  We do not have access to the patient records needed to identify hospital outpatients with Medicare coverage. Additional patient demographic information will also be required in order for MCL to file claims to Medicare.

 

Details of Medicare's Policy Change from CMS

Official Policy Change Document

To view the complete policy change document from CMS, please refer to Medicare CY 2018 Outpatient Prospective Payment System (OPPS) Final Rule Claims Accounting.

Revisions to the Laboratory Date of Service Policy

CMS has revised the current laboratory DOS policy for tests granted “advanced laboratory diagnostic test” status by CMS and molecular pathology tests that are excluded from the OPPS packaging policy so that the performing laboratory must bill and be paid by Medicare directly for these tests.

The general laboratory DOS rule, which specifies that the DOS is “the date the specimen was collected” will remain intact. However, outpatient hospital ADLT and molecular pathology tests performed on a specimen collected from a hospital outpatient are excluded from this rule, and the DOS should be “the date the test was performed.” This is a requirement. The performing laboratory will be required to bill Medicare directly for tests that meet this exception. Laboratories should not seek payment from hospitals for these services.

This new exception to the laboratory DOS policy will not apply to ADLTs or molecular pathology tests performed on a specimen collected from a hospital inpatient.

When Would DOS Be “the Date the Test Was Performed”?

A molecular pathology test (or an ADLT, as designated by CMS) will have the DOS as the date the test was performed only if:

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