HHS Unveils New Rules that Allow Patients Direct Access to Lab Results

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Recently, the U.S. Department of Health and Human Services (HHS) announced a new initiative to give patients better access to their health information through the use of health information technology (IT). The proposed rules, published by HHS Secretary Kathleen Sebelius, expand the rights of patients to access their health information by using IT. Most notably, the new rules will give patients access to their test results directly from labs.

Sebelius made the announcement at the inaugural HHS Consumer Health IT Summit in Washington, D.C. She noted, “When it comes to health care, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care.”

As noted in an HHS fact sheet, labs today can only release test results to the patient if the provider directly authorizes the laboratory to do so at the time the test is ordered, or if state law expressly allows it. Currently, 26 states lack laws that authorize disclosure of results directly to patients and 13 states prohibit direct disclosure to patients. Under the proposed rule, patients could request and receive their test results directly from laboratories.[1]

The proposed changes to the Clinical Laboratory Improvement Amendments of 1988  (CLIA) were a joint effort between the Centers for Medicare & Medicaid Service (CMS), the HHS office for Civil Rights (OCR), and the Centers for Disease Control and Prevention (CDC) in an attempt to give patients more rights in relation to accessing the results of their own lab tests. Patients will now be able to receive the results of their tests directly from labs that are covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

According to the HHS proposal, “The CMS Online Survey, Certification, and Reporting (OSCAR) database indicates that there are a total of 22,671 laboratories which provide approximately 6.1 billion tests annually in the 39 States and territories impacted by this rule…If the proposals contained in this rule are finalized, the majority of the 22,671 laboratories will need to develop processes and procedures to provide direct patient access to test reports.”

“As technology improves more aspects of our daily lives, it makes sense to marry cutting-edge technology with our medical and personal health records so that we can improve the quality and efficiency of the care that people receive,” said National Coordinator of Health Information Technology, Farzad Mostashari, MD, ScM, in the HHS statement.  In regard to health IT, there is now a strategic plan in place that outlines the details of the plan to empower consumers over the next five years.

 “Consumers need to know that private and secure access to their health information is a given,” Sebelius said. “The privacy and security of health data will be a top priority for OCR during my tenure.”

The new rules are open for public comment.  However, comments must be received no later than 60 days after date of publication in the Federal Register.  For more information, visit http://www.regulations.gov

BenefitMall will continue to keep you apprised of the latest developments as health care reform continues to evolve. For blog posts, legislative alerts, pools, surveys and other resources, visit www.HealthcareExchange.com and www.benefitmall.com.


[1] http://www.cms.gov/apps/media/press/factsheet.asp

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