Since around 2008, CMS has required both pathology test and clinical lab test samples to be processed with the claims date of service equal to the date of specimen collection. When the date of service fell during an hospital outpatient service day or coincided with the duration of an inpatient stay, payment rules followed hospital policy rules (often resulting in payment bundling.)
In fall 2018, CMS announced a change, with the net effect that a human molecular test from a hospital outpatient specimen could be billed by the lab that performed the test, rather than the originating hospital. For example, an Oncotype Dx breast cancer molecular test on a July 1 outpatient hospital biopsy in Chicago that was performed on July 5 by Genomic Health in California, could be billed to Medicare by the lab, not the hospital.
On the DOS page, CMS regularly updates a listing of the codes which fall under the "exception." Newly on June 23 and July 7, CMS added documents describing enforcement discretion until 2019. During the discretionary period, either the originating hospital or the providing laboratory can bill CMS for the test, but not both.
The CMS transmittal on the policy is CR10419, Claims Transmittal 4000, March 16, 2018, here.
A 3-page June 28 FAQ on the policy is here.
Two PDF documents (one a policy, one a new Q&A on the policy) are under a Zip file on the DOS page at the bottom (zip link should be here).
In their versions as available on 7/11/2018, I've put the six relevant documents together into one a cloud zip file:
- Excel of applicable test codes
- PDF explaining the above
- CR4000 from March 2018
- June 28 PDF Q&Q
- July 4 policy deferral to 2019
- July 4 Q&A on the deferral