In this penultimate post in Gravely Group’s series on the Information Blocking Exceptions from the ONC Final Rule, we continue to explore the exceptions that deal with how an Actor fulfills requests for access, exchange, or use of electronic health information (EHI). In this post, Gravely Group covers the Fees Exception.
The Fees Exception considers when an Actor’s Practice of charging fees for accessing, exchanging, or using EHI will not be considered information blocking. This exception permits an Actor to charge fees to recover costs that the Actor reasonably incurs in fulfilling a request to access, exchange, or use EHI, “including fees that result in a reasonable profit margin.”
Permitted Bases for Fees
To satisfy this exception, the fees an Actor charges must:
- Be based on objective and verifiable criteria that are uniformly applied across similarly situated classes of individuals or entities and across similar requests;
- Be reasonably allocated across all similarly situated individuals or entities who receive the technology, service, and/or for whom/which the technology is supported;
- Be reasonably related to the Actor’s costs of providing the type of access, exchange, or use to the individual/entity subject to the fee; AND
- Be based on costs that are not otherwise recovered for the same instance of service to a provider and third party.
Prohibited Bases for Fees
To satisfy this exception, the fees an Actor charges must not be based on:
- Whether the requestor/recipient is a competitor or potential competitor of the Actor or whether the use of the EHI will otherwise facilitate competition with the Actor;
- The value (sales, profit, revenue, or otherwise) that the requestor or others will or may derive from the access, exchange, or use of the EHI;
- Costs associated with designing or implementing health IT in a non-standard way, unless the requestor agreed to the fee for such non-standard design or implementation;
- Costs associated with intangible assets other than the actual development or acquisition costs of such assets;
- Opportunity costs that are unrelated to the access, exchange, or use of EHI; OR
- Costs related to the development of intellectual property (IP) if the Actor charged a royalty for that IP pursuant to the Licensing Exception and that royalty already included development costs for creating the IP.
Excluded Types of Fees
In addition to the prohibited bases for fees listed above, the following types of fees are specifically excluded from protection under the Fees Exception:
- Any fees prohibited by HIPAA under 45 C.F.R. § 164.524(c)(4) (addressing what a Covered Entity or Business Associate may and may not charge a patient for access to his/her own information);
- A fee based, in any part, on either:
- An individual’s Electronic Access to his/her own EHI; or
- Electronic Access by a person or entity designated by the individual;
- A fee to create an export of EHI via the capability of health IT certified to 45 C.F.R. § 170.315(b)(10) for purposes of either switching health IT or providing patients with their EHI;
- A fee to export or convert data from an EHR technology that was not agreed to in writing at the time the technology was acquired.
Compliance with Conditions of Certification
Developers of Certified Health IT must also ensure they are in compliance with all requirements of their Conditions of Certification, notwithstanding the Fees Exception.
 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health Certification Program, 85 Fed. Reg. 25642, 25959 (May 1, 2020), available at: https://www.federalregister.gov/d/2020-07419.
 For purposes of the Fees Exception, “Electronic Access” means: An internet-based method that makes EHI available at the time the EHI is requested without manual effort needed to fulfill the request.
 45 C.F.R. § 170.315(b)(10) deals with certification requirements related to single-patient and patient-population EHI exports.