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Archive for Federal Register

HHS recently published a final rule in the Federal Register amending Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the HIPAA Privacy Rule.

The final rule permits laboratories subject to CLIA to provide a patient, personal representative of a patient, or a person designated by a patient to obtain copies of test reports belonging to that patient. It amends the HIPAA Privacy Rule by removing the exception for CLIA-certified and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their PHI.

The regulations are effective April 7, 2014. HIPAA covered entities must comply with applicable requirements by October 6, 2014.

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A proposed rule published in the January 2 Federal Register would require covered health plans (CHP) to submit documentation demonstrating compliance with standards and operating rules for three electronic transactions:

•    Eligibility for a health plan
•    Healthcare claim status
•    Healthcare electronic funds transfers and remittance advice

CHPs would demonstrate compliance based on the HIPAA Credential or Coalition for Affordable Quality Healthcare CORE Phase III certification. CHPs that fail to meet the certification of compliance requirements described in the proposed rule would be subject to a penalty. The U.S. Department of Health and Human Services will accept comments on the proposed rule until March 3.

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