CLIA law permits lab data exchange, CMS says
By Mary Mosquera
Thursday, March 04, 2010
The Centers for Medicare and Medicaid Services (CMS) yesterday clarified that a 1988 law setting up national quality standards for medical testing labs does permit the labs to electronically exchange test data, an essential feature of the administration’s health IT adoption plan.
In issuing guidelines on the Clinical Laboratory Improvement Amendments (CLIA), CMS aimed to clear up confusion about the impact of the law on fledgling health information exchanges and networks.
“We have the concern that the interpretation of CLIA has sometimes stood in the way of easy info exchange,” said Dr. David Blumenthal in remarks made yesterday at the Healthcare Information and Management Systems Society annual conference in Atlanta.
In some cases, for instance, providers said they believed the law permitted only physicians who ordered a test to receive the results, according to hearings conducted last year by a panel of the Health IT Policy Committee, which advises Blumenthal.
In its revised guidance, CMS said lab results could be sent to the ordering physician as well as others designated by the physician. That includes providing patients access to their lab data unless a state specifically prohibits it, CMS said.
CMS also encouraged the use of certain standards for the exchange of lab data, including Health Level 7 (version 2.5.1), Logical Observation Identifiers Names and Codes (LOINC) and Nationwide Health Information Network specifications.
CMS made it clear that the visual inspection of electronic lab interfaces is not necessary within an electronic health record installation. And the law expressly allows lab data to be transmitted through a health information exchange.
“While this guidance furthers the ability of laboratories and EHRs to electronically send and receive laboratory data, it is not a panacea and more work must be done,” Blumenthal said in a March 3 blog post.
Some states have added their own restrictions to lab data sharing, for instance.
“If states want widespread health information for their population, then they must take into account that some state laws currently prohibit the release of test reports directly to patients and even to other providers treating the patient,” he said.
ONC is working on policies and frameworks that allow health information to be securely exchanged to allay state concerns, he added.
Last year, a panel of the Health IT Policy looked into hurdles preventing or slowing the exchange of lab data among providers and patients and how they could be overcome.
The group recommended that CMS explain how lab information should be presented in EHRs and health information exchanges using the standards.
The CMS guidelines including frequently asked questions is available online.
