We appreciate all of the comments that we received with regard to the right of individuals to access their laboratory test reports directly from laboratories. We agree with those commenters who stated that the rule is necessary to ensure patients have better and more complete access to their health information, which will enable patients to be more proactive and more informed with regard to their health care. However, we disagree with those commenters who argued that the rule would be redundant. While individuals do have a right of access to their health information under the HIPAA Privacy Rule, there may be circumstances when an ordering or treating provider is not subject to the HIPAA Privacy Rule (for example, because the provider does not bill health plans electronically) and, thus, is not required to provide an individual with access to his or her health information. Further, some studies have found that physician practices failed to inform patients of abnormal test results about seven percent of the time, resulting in a substantial number of patients not being informed by their providers of clinically significant tests results. Frequency of Failure To Inform Patients of Clinically Significant Outpatient Test Results, June 22, 2009, 169 (12): 1123-1129. The rule strengthens individuals' current ability to have access to completed test reports by ensuring they are able to access them directly from HIPAA-covered laboratories.
Therefore, we estimate the cost to provide patients with access to their laboratory test reports is estimated to be between $3 million and $63 million for 2013.
HHS Strengthens Patients’ Rights to Access Lab Test Reports
Other commenters stated that the proposed rule was redundant, and would add significant burden without a commensurate benefit to individuals, as existing HIPAA and HITECH Act (§ 13405(e)) laws already provide individuals with a comprehensive right to access their protected health information, including test reports, through their physicians. Further, some commenters stated that the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs,1 which include criteria to ensure that certain laboratory test reports become standardized elements in a certified EHR, are a better mechanism than the proposed rule to ensure more timely access to all health information. Thecommenters also stated that the information provided to individuals through the Medicare and Medicaid EHR Incentive Programs' requirements will be in a more consistent, more user-friendly, and more interoperable format than that obtained directly from a laboratory. Furthermore, commenters stated that many providers have already invested significant dollars and resources in secure patient portals to provide for individual access to health information directly from these providers.