On Wednesday, September 14, DHHS published a proposed rule in the Federal Register outlining proposed changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and to HIPAA that would enable patients to receive their lab reports directly from the laboratory. Under the current version of 45 C.F.R. § 164.524(a)(1)(iii), patients do not have a right of access to inspect and obtain a copy of their PHI maintained in a designated record set by a covered entity that is subject to CLIA. This is due to the fact that CLIA contains certain provisions that bar disclosure of information to patients. If the proposed rule becomes law, 45 C.F.R. § 164.524(a)(1)(iii) will be deleted, and the CLIA regulations at 42 C.F.R. § 493.1291 will be revised to permit disclosure of information by a CLIA-regulated laboratory directly to the patient. While the CLIA provision uses the term "may" and is thus permissive, DHHS notes that HIPAA's right to access is mandatory and therefore "the CLIA 'may' plus the HIPAA 'must' would result in a 'must disclose' for laboratories that are HIPAA covered entities."
The proposed change has drawn criticism from physician groups, who argue that the provision removes clinicians from the loop and leaves patients with clinical information that they are not equipped to understand. DHHS is accepting comments on the proposed rule; to be considered, the comments must be received no later than 5:00 p.m. on November 14, 2011. Detailed instructions for submitting comments, as well as the addresses to which comments should be sent, are included in the proposed rule.