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The Department of Health and Human Services’ Office for Civil Rights has announced that certain legislative changes made in the HIPAA Omnibus Final Rule of 2013 – Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act, and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules – have been reversed.
The reversal applies to a portion of the rule that expanded the third-party directive within the individual right of access (45 C.F.R. §164.524) “beyond requests for a copy of an electronic health record with respect to
The reversal followed the conclusion of legal action by the medical records provider, Ciox Health, challenging the changes. Ciox Health contracts with healthcare providers to maintain, retrieve, and produce individuals’ PHI. Ciox Health handles requests from healthcare providers to supply individuals’ PHI for treatment purposes, along with requests from patients exercising their rights under the HIPAA individual right of access, and requests to send PHI to legal and commercial entities. Ciox Health handles tens of millions of requests for PHI each year.
Ciox Health understood the fee limitations only applied to requests from individuals for access to their own PHI, and not to requests to send PHI to legal and commercial entities. However, in 2016, the Department of Health and Human Services (HHS) issued a guidance document in which it was made clear that the fee limitations had been expanded to include requests for PHI from legal and commercial entities. According to the lawsuit, that change resulted in Ciox Health and other medical records companies losing millions in revenue. The change was challenged as it was seen to be violative of the procedural and substantive protections of the Administrative Procedure Act (“APA”).
Ciox also challenged the types of labor costs that are recoverable under the fee limitation, the three methods for calculating fees for providing the records, and the 2013 change requiring medical records companies “to send PHI to third parties regardless of the format in which the PHI is contained and in the format specified by the patient.” The HHS filed a motion to dismiss and the cross-motions went before a federal court for summary judgment.
The HHS motion to dismiss was granted in part and denied in part, and the cross-motions were also granted in part and dismissed in part. The HHS motions to dismiss were denied in all cases apart from the three methods for calculating fees.
The court held that the rule requiring PHI to be delivered to third parties regardless of the records’ format was ‘arbitrary and capricious’ as it went beyond the requirements of the HITECH Act. The court also ruled in favor of the plaintiff on the challenge to the 2016 expansion of fee limitations, as this was a legislative change and the HHS failed to subject the change to notice and comment, in violation of the ACA. The 2016 explanation of what labor costs can be recovered was determined to be an interpretive rule and was therefore not subject to notice and comment.
The court declared the changes unlawful and vacated the 2016 expansion of fee limitations and the 2013 mandate broadening PHI delivery to third parties regardless of format. The Ciox Health, LLC v. Azar, et al court order can be viewed on this link.