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Final Rule Grants Patients Access to Test Results

Thursday, February 6, 2014

A new regulation by the Centers for Medicare and Medicaid Services (CMS) grants patients direct access to their laboratory results. It may also offer pathologists and the laboratory team a greater opportunity for direct patient consultation and education of test results. 

ASCP strongly supports the long-awaited rule, published in the Federal Register on Feb. 3. 

"For personalized medicine to reach its full potential, patients need to become more active partners in the management of their health."

“Information is power, and giving patients access to their test results empowers those willing to be actively involved in the management of their health,” ASCP wrote back in 2011 when the rule was first proposed. “Patients pay for the cost of the laboratory testing; they have a right to this information.”

In its 2011 comment, ASCP also noted that “for personalized medicine to reach its full potential, patients need to become more active partners in the management of their health. This proposal can help toward that aim.”

The new rule revises the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Health Insurance Privacy and Accountability Act (HIPAA) privacy rules to require laboratories to give a patient, or a person designated by the patient or his or her “personal representative” access to the patient’s completed test reports upon the patient’s or patient’s personal representative’s request.

In general, the rule requires laboratories provide individuals with access to their laboratory test reports within 30 days of the request. For the most part, the rule provides clinical laboratories with the flexibility to determine the processes that allow them to fulfill the patient’s request, including the process of verifying the identity of the patient. 

In comments on the draft rule, the Society voiced concerns it urged CMS to address. ASCP was concerned about the prospect that patients may turn to pathologists and laboratories to “interpret” the results. ASCP warned that patients need to consult “their clinician as the first resource for information to better understand test results and any need for follow up.” 

Since this primary provider has the patient’s complete medical history, he or she is in the best position to interpret the results.

CMS responded by clarifying this final rule “does not require that laboratories interpret test results for patients. Patients merely have the right to inspect and receive a copy of their completed test reports and other individually identifiable health information maintained in a designated record set by a Health Insurance Portability and Accountability Act (HIPAA)-covered laboratory. Laboratories may continue to refer patients with questions about the test results back to their ordering or treating providers.” 

To obtain a copy of ASCP’s comments on the 2011 proposed rule, click here.

 For further reading, visit "New Rule Gives Patients More Access" on
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