CMS seeking stakeholder feedback on lab DOS changes

CMS is proposing several revisions to its clinical diagnostic laboratory date of service (DOS) policy in the FY 2020 OPPS proposed rule, including requiring ordering physicians to determine whether tests are intended to guide treatment during a current or future outpatient encounter.

Under the current policy, advanced diagnostic laboratory tests (ADLT) and molecular pathology tests are excluded from OPPS packaging policy so that the DOS is the date the test was performed, if the following conditions are met:

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

ADLTs and molecular pathology tests that fall under this exception are essentially unbundled and the lab must bill Medicare directly rather than billing the hospital outpatient department. The exception was originally set to go into effect in 2018 but CMS has extended the enforcement discretion period to January 2020.

CMS is considering three changes to the DOS exception:

• Changing the test results requirement
• Excluding blood banks and blood centers from the DOS exception
• Limiting the DOS exception to ADLTs

Regarding the first proposed change, CMS states that it no longer believes that a molecular pathology test or ADLT is separable from a hospital service if the results are not intended to guide treatment during that specific hospital outpatient encounter. CMS now considers that a molecular pathology test or ADLT performed on a specimen collected during a hospital outpatient is a hospital service if the results are intended to guide treatment during a future hospital outpatient encounter. Under the proposed change, the test would be considered a hospital service, even if the other four conditions are met, if the physician determines that the results will be used to guide treatment at a future hospital outpatient encounter.

CMS is particularly interested in comments on its position that molecular pathology tests and ADLTs are hospital services when the results will be used to guide treatment at a future hospital outpatient encounter. It is also interested in feedback on the potential administrative implications of requiring the ordering physician to determine when the test results are not intended to guide treatment during a future hospital outpatient encounter. Comments are due to CMS by September 27.

To learn more about the proposed rule’s policies and what payment impact they could have at your facility, attend HCPro’s annual OPPS proposed rule webinar on Tuesday, August 27, with Jugna Shah, MPH, and Valerie A. Rinkle, MPA, lead regulatory specialist and an instructor for HCPro Medicare boot camps.