The Office of the National Coordinator (ONC)’s Cures Act Final Rule (known as the “Info Blocking Rule” and available at 45 CFR § 171) was designed to provide patients with access to their electronic health information at no cost. The Info Blocking Rule requires health care providers (including health centers) to respond to patient requests without unreasonable delay, unless one of the limited exceptions applies. Since April 5, 2021 (the applicability date), the ONC has encouraged the public to report potential information blocking. Over the past several months, the ONC started releasing details about the info blocking claims it has received.

Process for Reporting Info Blocking

The Cures Act directed the ONC to implement a standardized process for the public to report claims of possible information blocking. Anyone who believes they may have experienced or observed information blocking by a health care provider, health IT developer of certified health IT, or health information network or health information exchange may report through the ONC Report Information Blocking Portal. Reporters, who may remain anonymous, are asked to include the following information:

• Person or entity that requested access, exchange or use of electronic health information
• Type of electronic health information requested (e.g., lab result, medical history, diagnostic images)
• Type/purpose of request (e.g., patient request to access records, health care provider request to export patient records)
• Health IT being used by the requestor (e.g., system and version)
• Person or entity that denied/did not fulfill the request to access, exchange or use EHI, including the role of the person/entity, date and time the request was denied/not fulfilled, and location
• Health IT being used by the person or entity that denied/did not fulfill the request to access, exchange or use electronic health information
• Reason/response provided for why the request to access, exchange or use electronic health information was denied/not fulfilled, including date and time the request was denied/not fulfilled and date and time the reason/response was provided to the requestor

The ONC Report Information Blocking Portal also directs reporters to file complaints about HIPAA covered entities or business associates directly to the Office for Civil Rights (OCR).

Info Blocking Complaint Data

In February of 2022, the ONC started posting data on the info blocking claims received. The data on info blocking complaints, updated each month, currently reflects that since April 5, 2021, the ONC has received the following:

In a blog that accompanied the initial release of info blocking claims data in February, the ONC included the following examples of complaints received that appeared to meet the definition of information blocking:

• Patient complaints of being charged fees for electronic access to their electronic health information
• Patient complaints of unnecessary delays in receiving access to their electronic health information
• Health care provider complaints of being charged excessive fees to export electronic health information to a new electronic medical records system
• Health care provider complaints of unnecessary delays in receiving electronic health information requested for their patients

Whether information blocking occurred would depend on the full facts and circumstances of each specific case. The Cures Act gives the HHS Office of the Inspector General (OIG) the responsibility of investigating any claim of potential information blocking related to health care providers, health information networks and health information exchanges, and health IT developers of certified health IT. According to a FAQ published by the ONC, its goal is to share complaint details with the OIG within two days of receipt. The ONC also has authority to review claims of potential information blocking against health IT developers and certified health IT related to non-conformity with the ONC Health IT Certification Program. The ONC recently released a document that describes the review and investigation process.

If the OIG’s investigation determines that a health care provider’s conduct meets the definition of information blocking, the health care provider may be subject to “appropriate disincentives.” The OIG is expected to release details on the appropriate disincentives, including monetary penalties, in future rulemaking.

Key Takeaways

Health centers continue to work with their patients, electronic medical records systems and health information exchanges to respond to requests for access, use and exchange of electronic health information and to comply with the Info Blocking Rule. Key takeaways from the ONC data on info blocking complaints received include:

• Ensure your health center has a process to receive and respond to requests for access, use and exchange of electronic health information. Ensure your health center has documented its efforts to comply with the Info Blocking Rule, including any exceptions that apply.
• Respond to complaints from patients related to their requests for access, use and exchange of electronic health information. The ONC info blocking complaint data reflects that patients and their advocates are aware of and reporting to the ONC Report Information Blocking Portal. While a health center cannot prohibit a patient from filing a complaint with the ONC or OCR, if the patient first complains to your health center, a robust response could dissuade the patient from filing a complaint with the ONC or OCR. Ensure your health center documents its response to the individual patient as well as any corrective action steps taken by the health center.
• Ensure your EMR vendor is meeting its obligations to provide access, use and exchange of electronic health information, especially if your health center is changing vendors. Health centers that experience unreasonable delays and fees related to transferring data to their new EMR vendor should recognize the EMR vendor’s actions may constitute information blocking which could be reported to the ONC.

For questions on compliance with the ONC Info Blocking Rule, please contact Dianne K. Pledgie at dpledgie@feldesman.com or 202.466.8960.