Part two of a two-part series. For part one, read Lab guidance update upstaged by certification ruleThis month, the CMS sought to change the status quo of legal constraints and folkloric practices involving health information exchange between laboratories and providers.
On March 1, when it released its 18-page guidance to interpreting the Clinical Laboratory Improvement Amendments, also known as CLIA, the CMS sought to clarify under what circumstances electronic data from lab test results could move back to providers, directly to patients, or to and through health information exchanges.
For example, the CMS opined that—contrary to common practice—labs do not need to visually inspect each provider's electronic health-record system to ensure that an EHR is accurately receiving data from the lab's own electronic record system.
Mind you, the CMS did not absolve labs of their responsibility to test and ensure that they are transmitting accurate data and that their interfaces to provider systems are working properly, but the guidance allows that better ways might exist to perform such tests other than conducting site visits to eyeball providers' computer screens.
These and other directives could make it easier for office-based physicians to meet the meaningful-use criteria and qualify for federal subsidy payments for the purchase of electronic health-record systems under the American Recovery and Reinvestment Act of 2009, also known as the stimulus law.
Meanwhile, the guidance is proving to be unsettling for privacy advocates, who see it as a means to further erode patient control over their electronic health information.
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.”
The guidance language about labs not being required to visually inspect the efficacy of each lab interface with a provider's EHR could remove an impediment to providers wanting to obtain federal subsidy payments for the purchase of health IT under the stimulus law.
Electronically moving lab orders and receiving test results are expected to be components of meaningful-use criteria physicians must meet to qualify for federal EHR subsidy payments under the stimulus law.
Several witnesses at an Oct. 20, 2009, public hearing before a workgroup of the federally chartered
Health Information Technology Policy Committee said that because CLIA holds labs responsible for ensuring their data transmissions reach the “final report destination” intact, lab personnel must visually inspect the display of a lab test report on a physician's EHR.
This perceived requirement created a bottleneck for implementation of lab interfaces to physician EHR systems and might have been—absent the recent guidance—a major obstacle to widespread adoption of these interfaces, particularly at small office practices. These on-site verifications are time-consuming and could impede an expected rush by physicians to get lab interfaces built into the EHRs to achieve meaningful use under the stimulus law, warned Donald Horton, vice president of public policy and advocacy for Laboratory Corporation of America Holdings, at the October meeting.
In addition, clinical labs have “no control” over modifications to a test result report made by EHR vendors in displaying the results on their systems, and the same holds true for health information exchanges, he said. Horton said he favors releasing labs from the responsibility of ensuring that EHRs properly display their electronically transmitted results. He advocates this requirement be covered under the EHR system certification process that is a part of the stimulus act.
“In the current electronic health-information exchange environment, ‘final report destination' has become a virtually meaningless term,” Horton said, because the exchanges themselves can modify what they end up transmitting to physicians and other providers. Labs' responsibilities should end once they ship the result in a standardized format to the provider or other intermediary, he said.
That concern appears to have been addressed by the guidance as well. “When the authorized person, and individual responsible for using the test results receives the results, the laboratory's CLIA responsibility ends,” according to the guidance.
The CMS hardly went far enough in the guidance to address privacy issues, according to Deborah Peel, an Austin, Texas, psychiatrist and founder of the Patient Privacy Rights Foundation.
“There's a lot of disappointing stuff in here, starting with the goal,” Peel said. “The goal is to create an environment to have access. The goal is wrong. It should be to have access to health information exchange in ways that preserve Americans' long-standing rights to health-information privacy and control over health information for all routine uses.”
Peel said she also objects to guidance provisions that condone and facilitate labs giving patients' test results directly to health information exchanges without patient consent, which should be given only after the patient sees the test results.
“You can't in advance give consent to disclose information that doesn't exist yet,” she said. “This is highly offensive to consumers. They should have the option, if the test result is sensitive, they should have the right to not disclose it.”
Peel also noted that the guidance does not take into consideration the new stimulus law provision that patients have the right to bar the sharing of their records with their insurance companies for treatments or procedures they pay for out of pocket.
“This direct sharing from laboratories and payers, there should be a new way to block that to be compliant with the new protections,” Peel said.
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