The goal of the guidance, stated on its first page, is to support the commitment by HHS and the CMS “to create an environment in which most Americans will have access to health information exchange and electronic health records by 2014,” a goal set first by President George W. Bush in 2004.
Several sections of the new CMS guidance address the issue of who can and cannot receive electronic lab results.
For example, one section contains an expanded definition of “authorized person,” a key CLIA term. Another section addresses an expanded definition of “individuals responsible for using test results.” Under CLIA, an authorized person and an individual responsible for using test results are allowed to receive results from a lab, if also permitted by state laws, which can trump CLIA.
The guidance notes that some states expressly authorize patients to order tests and access their own test results, regardless of who ordered the test. Laws in these states permit labs to release results directly to a patient as an authorized person, it said.
The guidance also says that in some states patients may be considered to be “individuals responsible for using test results” and thus qualify to receive their own lab results, if laws in those states do not expressly prohibit release of results directly to patients.
The guidance also spells out that labs may hire agents to assist in moving results to whoever ordered the test and others who are identified in the test order as persons responsible for using the results.
The guidance also tells labs that results “must” be released “to any additional individuals/entities designated on the test requisition.” These entities, so designated, are understood to be “responsible for using” the test results.
This and the preceding language changes appear to provide a pathway for labs to directly transmit test results through a health information exchange or to a personal health-record service, according to materials in the question-and-answer section of the guidance.
“An authorized person may contract with an EHR vendor or HIE to serve as their agent,” the guidance states. As an agent, an HIE “could then receive test reports from laboratories on behalf of that authorized person.”
“To do so,” according to the CMS, “authorized persons might designate these persons/entities as the final report destination on the test requisition. Based on that requisition, the laboratory would then be able to send the test results to the identified EHR vendors or HIEs.”