The American Hospital Association (AHA) has responded to a triumvirate of federal agencies’ proposed rule on patients’ access to test reports, warning them of unintended burdens that come with the proposed rule.
According to the Nov. 14 letter to Donald M. Berwick, administrator of the Centers for Medicare & Medicaid Services (CMS), the proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon a patient’s request, the laboratory may provide access to completed laboratory test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient.
The proposed rule would also eliminate the current exception in the HIPAA Privacy Rule to patients’ rights to access their completed laboratory test reports directly from a HIPAA-covered entity that also is a CLIA-covered lab.
While AHA stated it believes the proposed regulatory changes are necessary to remove existing barriers to the exchange of health information and to provide patients with the ability to play a more active role in their personal healthcare decisions, the Washington, D.C.-based AHA stated that CMS should be aware that making these changes will pose significant operational challenges for hospital laboratories, particularly for those hospitals that not only provide lab testing for their own patients but also act as reference labs for external providers.
“CMS should consider the significantly increased cost and burden, well beyond that described in the proposed rule that hospitals with reference labs will incur to comply with these provisions,” the letter continued.
According to AHA, nearly all hospitals operate in-house clinical labs that provide testing for hospitals’ inpatients and outpatients. “However, a significant compliance challenge will result because many hospitals, both large and small (including critical access hospitals), also function as reference laboratories,” Rick Pollack, executive VP of AHA, wrote. “That is, they accept patient specimens for testing purposes from outside providers, such as other clinical laboratories or community physician offices. Hospitals provide these services for multiple reasons, including improving access to clinical laboratory testing in underserved communities, providing access to more advanced testing that otherwise would not be offered in their area, or as an additional line of business to improve the hospital’s overall revenue.”
Hospital-based reference laboratories often process huge volumes of tests each day, not just those sent from local community providers, but also from national and even international sources, the letter added. As a result, the burden of compliance with the proposed rules will likely be significantly greater than the estimate provided by CMS.
According to Pollack, labs will need to have processes and trained personnel in place to perform a number of steps to give patients copies of their lab reports, including:
- Receive a request from an individual;
- Authenticate the identity of the individual requesting a particular laboratory test report;
- Retrieve the test reports from the hospital laboratory’s information system;
- Verify the preferred route for sending the laboratory test report;
- Transmit the report; and
- Document that the report was sent.
“It is important that all relevant regulatory agencies help patients understand the difference between the right to ask for a copy of a completed lab test report, which the proposed rule would enable, and an interpretation of the results, which is appropriately left to the ordering and/or treating physicians,” the letter concluded.