ONC’s Cures Act Final Rule.

In this article I will discuss how federal regulations adopted on May 1, 2020 dramatically change the rules of the game on how patients can access their electronic health records, and what fees can be charged for such records.

The 21st Century Cures Act.

The 21st Century Cures Act was adopted in 2016 to help accelerate medical product development and bring new innovations to patients including improved access to medical records.

This Act encourages the “interoperability” of electronic health records. The term interoperability means “. . . such health information technology that . . . allows for complete access, exchange, and use of all electronically accessible health information for authorized use . . .”  Public Law 114-255, Sec. 4003 (a).

Although the HITECH Act had a similar objective, many entities engaged in actions that made it difficult for individuals to access health information technology. See the ONC Report on Health Information Blocking.

Consequently, the Cures Act prohibits information blocking, defined as “. . . a practice that . . . is likely to interfere with, prevent, or materially discourage access, exchange, or the use of electronic health information”. Sec. 4004 (a). Any individual or entity found to have committed information blocking is subject to a civil penalty of up to $1 million per violation. Sec. 4004 (b).

ONC’s Cures Act Final Rule.

The Cures Act directed the Office of the National Coordinator for Health IT (ONC) to issue regulations to implement its provisions. These regulations were published on May 1, 2020 and took effect on June 30, 2020. See the ONC’s Final Rule.

With regards to fees charged for medical records, the ONC Final Rule specifies a “fees exception” that explains when such fees will not be considered unlawful information blocking. See 45 C.F.R § 171.302.

The Rule then creates two situations where this fees exception does NOT apply. First, the exception does NOT apply to fees prohibited by 45 C.F.R. § 164.524(c)(4). § 164.524(c)(4) limits the fee to the cost of copying protected health information requested by the individual plus postage. See § 171.302(b)(1).

Since it does not cost any more to reproduce a 1 page electronic record than it does to reproduce a 500 page electronic record, this provision prohibits the practice of charging attorneys on a per page basis for the individual’s electronic health records.

Second, the fees exception does NOT apply to “[a] fee based in any part on the electronic access of an individual’s EHI by the individual, their personal representative, or another person or entity designated by the individual; . . .” (emphasis added)  See § 171.302(b)(2).

By excluding a “fee based in any part on the electronic access of an individual’s EHI”, the Rule makes any fee for electronic access to an individual’s EHI unlawful information blocking. Further, the Rule includes in its prohibition a fee charged to a “person or entity designated by the individual”. Clearly, an attorney can be designated by the individual to receive his/her EHI.

Attorneys must be mindful that this prohibition of fees ONLY applies to the individual’s records obtained via electronic access. “Electronic access means an internet based method that makes electronic health information available at the time the electronic health information is requested and where no manual effort is required to fulfill the request.” § 171.302(d).

As of June 30, 2020, the date the ONC Final Rule took effect, many health care providers do not provide patients with access to their records via an internet based method. However, the Cures Act contains other provisions that require health care providers to make electronic health information available via internet based methods such as online portals and apps. Thus, the usefulness of 45 C.F.R § 171.302(b)(2) will increase as more health care providers adopt internet based methods.

Without question, much of the language of the ONC Final Rule is convoluted. The 21st Century Cures Act prohibits information blocking. The Final Rule creates a Fees Exception to this prohibition. The Final Rule then creates two important exceptions to the Fees Exception.

In other words, Congress created a prohibition, then an exception to the prohibition, then an exception to the exception, thereby making the exception to the exception part of the prohibition on information blocking. It takes some persistence to navigate through this convoluted regulatory maze.

Practice Tips.

1. Electronic health information (EHI) does NOT include psychotherapy notes or “information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding”. § 171.102.

2. I recommend attorneys stop using a HITECH medical records request form and instead use a HIPAA compliant medical Release that makes reference to the 21st Century Cures Act.  For a form to consider, click on Cures Act Release.

3. Health care providers have until November 2, 2020 to comply with the ONC Final Rule. See § 171.101(b). It is going to take some time for health care providers to change their procedures and for the Final Rule to become the new normal.

4. To access the legal authority for the ONC’s Cures Act Final Rule, click on one of the links below.

If you found this Article helpful, please do me a favor and post a favorable comment below. Thank you.

Sources.

The 21st Century Cures Act.

Public Law 114-255, Sec. 4003.

Public Law 114-255, Sec. 4004.

45 C.F.R. 171.100 et seq..

45 C.F.R. 164.524

ONC's Cures Act Final Rule

Disability Lawyer David R. Paletta