21st Century Cures Act

October 26, 2020

Dear Customers,

We wanted to highlight for you certain features and requirements of the interoperability and information blocking rules that were recently published pursuant to the 21st Century Cures Act. The new rules were designed to advance interoperability and support the access, exchange, and use of electronic health information, or "EHI,” for patients and others with valid authority to access it. The rules do not significantly change HIPAA requirements, nor do they create any new rights to access information, but they may change the format and timing of responses to certain requests for EHI, as well as the tools available to patients and others to request and receive that information. Any interference with a patient’s (or other authorized person’s) timely access to EHI could be viewed as “information blocking” under these rules, and with some exceptions, is generally prohibited.

To comply with the information blocking provisions of the new rules, health care providers should provide patients with access to EHI1 on a timely basis.2 This functionality already exists at practices that utilize either the My Care Plus or Navigating Care patient portals, which integrate with the iKnowMedSM EHR. However, the current approach to releasing laboratory results and clinical notes warrant particular attention as these elements of the patient record are not automatically released to the patient portal. To ensure that practices are providing patients with timely electronic access to this information in an acceptable and clinically appropriate manner, we recommend establishing written procedures related to these data elements to incorporate the following policies:

  • Laboratory results. Laboratory results are reviewed by the patient’s clinician as soon as practicable, but within no longer than three (3) business days after receipt of the lab result by the practice.3The patient’s clinician will either review and approve the data to be posted to the patient portal (i.e. cleared from the clinician’s review queue) or determine if an exception applies.

  • Clinical notes. When requested by a patient (or other authorized person), clinical notes will be provided in a secure electronic format4 as soon as practicable, but within no longer than 10 business days of the request.5

  • Exceptions. The information blocking rule permits certain, limited exceptions for timely providing EHI, and states may have their own existing laws that dictate how and when the information should be shared with a patient. Practices should consult with their practice attorney for any such state requirements. Examples of exceptions may include, but are not limited to:

    • Laboratory results that require the opportunity for immediate counseling coordinated with the release of the results, based on state law;

    • Laboratory results or clinical notes that may be delivered via a different mechanism or process to prevent harm to the patient; Psychotherapy notes; and

    • Records created in anticipation of litigation

Based on a good faith assessment of currently available information from the Department of Health and Human Services, we believe that the timeframes outlined above can reasonably be considered timely under the circumstances and meet the intent of the rules, provided the practice does not impose any unnecessary delays. We recommend that these procedures be implemented by no later than November 2, 2020, which is the current effective date of the information blocking provisions of the rules; however, practice decision-making, including how best to comply with legal and regulatory requirements, ultimately resides with practice leadership.

Although these procedures relating to laboratory results and clinical notes may have the most significant impact on your practice, there are several other provisions in the new rules that we wanted to highlight for you:

  • First, under existing CMS requirements, health care providers must attest they have acted in good faith to support interoperability and the appropriate exchange of EHI when submitting annual MIPS reporting data (by March 31, 2021). Under the new rules and starting in late 2020 (for performance year 2019), CMS will post this indicator on Physician Compare, allowing the public to view which providers responded negatively to these attestation requirements. This new public reporting is meant to discourage providers from information blocking and help Medicare patients and caregivers make informed decisions.

  • Second, although not yet specified, HHS may also impose penalties or other disincentives in the future against providers who engage in prohibited information blocking. We will continue to monitor this and keep practices apprised of any developments.

  • Third, the National Plan & Provider Enumeration System (NPPES) now allows health care providers to publish “digital contact information,” also known as “digital endpoints” on its NPI registry. These digital endpoints, such as a FHIR URL or Direct Messaging Address, promote the sharing of information both with other providers and patients (through the use of patient apps), and were described by CMS as “a crucial step towards eliminating the use of fax machines for the exchange of health information.” Additionally, to encourage their use, CMS will publicly report the names and NPIs of providers who do not have digital contact information included in NPPES beginning in the second half of 2020.

  • Fourth, the rules have updated the certification criteria and certain technology standards required for certified health IT, including electronic health records like iKnowMed. We are working with our technology team to implement these new standards before the compliance dates in 2022 and 2023.

For more information on the rules, visit: https://www.healthit.gov/curesrule/

If you have any questions relating to these recommendations, please reach out to your iKnowMed account manager. Thank you for your attention to these important updates.

Steve Beier
VP and GM, Technology Solutions

 

1 EHI for the purposes of the information blocking prohibition consists of USCDI version 1 elements. More information can be found here: https://www.healthit.gov/isa/sites/isa/files/2020-10/USCDI-Version-1-July-2020-Errata-Final_0.pdf.

2 Note that the information blocking prohibition and standards for timely access to EHI apply also to other authorized requests for access to EHI, including by other health care providers or by insurance companies and other payers.

3 Exceptions may be made to this timeframe on a case-by-case basis, for legitimate and necessary reasons, as approved in writing by Practice leadership.

4 Please see the instructions document provided with this communication, which explains how to create a machine-readable html or pdf file and send to the patient.

5 Exceptions may be made to this timeframe on a case-by-case basis, for legitimate and necessary reasons, as approved in writing by Practice leadership.