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Labs Advised Not to Delay Release of Test Results Under Patient Access Rule

by | Feb 25, 2015

While laboratories will have up to 30 days to provide patients with completed test reports following a request under the so-called “patient access rule,” officials with the Centers for Medicare and Medicaid Services (CMS) say they expect that labs will deliver results as soon as the final report is available. “Patients should be able to […]

While laboratories will have up to 30 days to provide patients with completed test reports following a request under the so-called “patient access rule,” officials with the Centers for Medicare and Medicaid Services (CMS) say they expect that labs will deliver results as soon as the final report is available. “Patients should be able to get their results immediately,” says Karen Dyer, deputy director of CMS’s Division of Laboratory Services, Survey and Certification Group. “Labs can’t delay sending results.” According to the final rule giving patients access to their test reports, laboratories will be required to provide individuals with access to their laboratory reports within 30 days of the request. However, “with a very limited exception, covered entities may not deny an individual access to his/her health information based on the information’s sensitive nature or potential for causing distress to the individual,” says Dyer. Dyer’s comments came in response to an article published in the August issue of National Intelligence Report detailing practical strategies that labs are planning to use to comply with the Oct. 6, 2014, compliance date for the patient access rule. The article was based on a July 31 webinar sponsored by G2 Intelligence. During the webinar, Marguerite Busch, vice president and chief compliance officer for PAML, a large reference laboratory based in Spokane, Wash., suggested that labs consider delaying release of results to patients for 48 hours (or other time frame) after the ordering provider would have received the results. In the case of sensitive tests, Busch suggested that labs may want to delay release of results for 21 days. In both cases, the goal of the delay would be to give the referring physician time to discuss results with patients prior to their receiving the results. While both of these scenarios technically fall within the requirements of the final rule, Dyer and Judy Yost, director of the Division of Laboratory Services at CMS, tell NIR that they do not comport with the “intent” of the rule, which is that patients receive results as quickly as possible. Dyer and Yost advise that labs not delay release of test results to patients for any reason. CMS also clarified a statement made by NIR that labs must be prepared to e-mail test results upon request. “The HIPAA Privacy Rule does not require that a HIPAA-covered laboratory have the capability to produce a copy of a completed test report in whatever electronic format or manner the individual requests,” the agency said in a statement. “The Rule allows a covered laboratory to make some other agreement with individuals as an alternative means to provide a readable electronic copy to the individual where the covered laboratory is not able to readily provide the form of electronic copy requested. If the individual declines to accept any of the electronic formats that the laboratory can produce, the laboratory must provide a hard copy as an option to fulfill the request.” For specific requirements under the new mandate, labs are advised to see the final rule, published in the Feb. 6, 2014, Federal Register.

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