The CMS has drafted a proposed rule (PDF)
affecting the electronic movement of lab test results to patients, according to a posting on the Office of the Federal Register
The proposed rule, slated to be published in Wednesday's issue of the Federal Register, would amend the patient privacy provisions of two federal laws, the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and the Health Insurance Portability and Accountability Act of 1996, or HIPAA.
According to a summary of the 45-page proposed rule, under the current regulations, "CLIA limits a laboratory's disclosure of laboratory test results to three categories of individuals: the 'authorized person,' the person responsible for using the test results in the treatment context, and, in the case of reference laboratories, the referring lab." Under the current CLIA rule, an authorized person is defined as "the individual authorized under state law to order or receive test results, or both."
The summary notes that some states do not allow patients to have direct access to their test results and must instead "receive his or her results through the ordering provider."
The rulemakers state that the federally chartered Health IT Policy Committee concluded that "CLIA regulations are perceived by some stakeholders as imposing barriers to the exchange of health information." The complaining stakeholders, they write, include "large and medium-sized laboratories, some public health laboratories, electronic health-record system vendors, health policy experts, health information exchange organizations (HIOs) and healthcare providers who believe that the individual's access to his or her own records is impeded, preventing patients from a more active role in their personal healthcare decisions."
In response, the CMS' rulemakers propose amending CLIA so that, at a patient's request, labs would be allowed "to provide direct patient access to (their) completed test reports."
The proposed rule also would amend the HIPAA privacy rule, which generally provides patients with a right of access to their medical records but which carved out an exception to honor the aforementioned state laws restricting lab results reporting. The proposed amendment would eliminate that exception and give patients a right under HIPAA to have direct access to their labs results at CLIA and CLIA-exempt labs.