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OMB Extends Review of Rule That Would Require Labs to Release Results to Patients

The Office of Management and Budget has extended its review of a proposed rule  that would require HIPAA-covered laboratories to make test results available to patients.  In our previous post on this issue way back in September 2011, we explained that giving patients access to test results is easier said than done for independent laboratories because their communication with patients is typically limited to the specimen collection process and conversations about billing issues.

The delay is not surprising given the amount of controversy around the proposed rule.  For example, the American Clinical Laboratory Association submitted comments explaining the risks and burdens this significant regulatory change would place on independent laboratories, and the American Association of Medical Colleges believes that certain types of results - such as those related to life-threatening conditions - should be delivered only by the treating physician.  At the same time, many patient advocacy groups strongly support this regulatory change.

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Karen S. Lovitch

Member / Chair, Health Law Practice

Karen S. Lovitch is a Mintz attorney who represents health care companies in regulatory, transactional, and operational matters. She advises them on health care regulations such as the Stark Law and the Clinical Laboratory Improvement Amendments of 1988.