CMS Take Steps to Modernize Clinical Lab Policies



In Depth

Through two recently issued regulations, the Centers for Medicare and Medicaid Services have announced their intention to reform and improve Medicare policies addressing clinical diagnostic laboratory services. These policies will increase patient access to completed test results and will rebase Medicare payment rates based on changes in lab technology.

On February 3, the Centers for Medicare and Medicaid Services (CMS) took another step toward reforming clinical lab policies. In a final rule, CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports, CMS give patients the right to obtain results of laboratory tests directly from the lab that performed the test and require labs to release the results to the patient, the patient’s representative or another person designated by the patient.

Before implementation of the rule, a patient’s right to access his/her medical records did not extend to clinical laboratories regulated under the Clinical Laboratory Improvement Amendments. Patients who wanted access to lab results generally were required to obtain them from the hospital or their treating physician who ordered the test.

The new final rule requires that, upon request of the patient or the patient’s representative, the lab provide “access to completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient … in the form and format requested by the individual, if a copy in that form or format is readily producible.” The rule elaborates on this issue, stating:

For example, if a HIPAA-covered laboratory receives a request from an individual to have access to test reports through a web-based portal, but the only readily producible version of the protected health information by the laboratory is in PDF, the Privacy Rule requires the laboratory to provide the individual with the PDF copy of the protected health information, if the individual agrees to receive it in that form. If the individual declines to receive the PDF copy, the laboratory may provide the individual with a hard copy of the information.

Late in 2013, CMS finalized another major policy change affecting clinical laboratory services. In a final rule on Medicare payment policies, CMS established a new process whereby they will review and update payment rates under the Clinical Laboratory Fee Schedule (CLFS). This process will allow CMS to review tests payable under the CLFS and to adjust payments for those which have undergone technological changes. In final rule, CMS define technological changes as “changes to the tools, machines, supplies, labor, instruments, skills, techniques, and devices by which laboratory tests are produced and used.” This process marks the first time that CMS will adjust payment rates for individual tests paid under the CLFS, and it could lead to substantial changes—likely, reductions in Medicare payment for lab services.

The most recent changes bring increased regulatory burdens on labs, while simultaneously setting up a structure to reduce Medicare payments for lab services.

CMS 2319-F is available here:

The CY 2014 Medicare Physician Fee Schedule is available here:

Additional information available here: