New Regulation Allows Patients to Receive Test Results Directly from Labs

A new rule allowing patients to obtain their test results directly from clinical labs went into effect April 7, 2014. If you’re reading this for the first time, there’s no need to panic. This regulation is intended for HIPAA-covered clinical labs. These labs have until Oct. 6, 2014, to comply with the new regulations.

While this may seem like it could potentially save patients time, physicians have expressed significant concerns, especially if a patient chooses not to follow up with their physician once they obtain their test results.

Here are some steps physicians can take to be prepared:

  • Connect with the clinical labs you work with and become familiar with their new policies and procedures for providing patient access to test results.
  • If possible, try to work with your labs in timing the release of the information to your patients. Coordinate the release so that you are able to communicate with your patient before they receive the results directly from the clinical labs.
  • If not already part of your practice, be prepared to tell your patients, if asked, where their lab work has been sent and how they can get in contact with the lab to receive their results.

Read more in a blog written by Angela Boateng, regulatory counsel at the Pennsylvania Medical Society.

Under the HIPAA Privacy Rule, labs will be required to provide individuals with their test results within 30 days (with one 30-day extension, if necessary), which the Centers for Medicare and Medicaid Services (CMS) believes provides ample time to ensure providers receive sensitive test reports before the patient and to allow providers to counsel individuals on the test reports. CMS emphasized that clinical labs are not required to interpret test results and that this rule does not change the role of the provider in reporting and explaining test results to patients.

CMS also believes that the rule will further encourage providers, at the time the test is ordered, to counsel patients on the potential outcomes of a test and what they may mean for the patient, given his or her medical history.

The requirement to release the report directly to the patient applies only to HIPAA-covered labs; however, virtually all labs are HIPAA-covered entities. Labs that are HIPAA-covered entities are required by this final rule to provide, upon request by an individual or the individual’s personal representative, access to the protected health information about the individual maintained in a designated record set in accordance with the HIPAA Privacy Rule.