Transmission to cancer registries

Clarifications:

• For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
• This certification criterion is intended for technology designed for the ambulatory setting.
• We have not adopted a “cancer case information” certification criterion. This decision has no impact on the requirements of the “transmission to cancer registries” certification criterion or the requirements of the Implementation Guide (IG). Certification to the “Transmission to cancer registries” criterion requires a Health IT Module to demonstrate that it can create a file with the necessary cancer case information in accordance with the IG. [see also 80 FR 62667]
• “Cancer case information” is synonymous with the “cancer event reports” or “cancer reports” referred to in the HL7^® IG for CDA Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, DSTU Release 1.1.

Technical outcome – The health IT can create cancer case information for electronic transmission in accordance with the HL7^® IG for CDA^® Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, DSTU Release 1.1.

Clarifications:

• The CDC published an updated version of the Implementation Guide for reporting to cancer registries (HL7^® IG for CDA^® Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1; DSTU Release 1.1, U.S. Realm (“Release 1.1.”)). Release 1.1 involves technical corrections to Release 1. No new content has been included. ONC refers developers to the DSTU Release 1.1 for a full list of the updates. [see also 80 FR 62666]
• In order to mitigate potential interoperability errors and inconsistent implementation of the HL7^® CDA^® Release 2 IG: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1 – US Realm, ONC assesses, approves, and incorporates corrections (Errata) as part of required testing and certification to this criterion. Compliance with the following corrections is necessary because they implement updates to vocabularies, update rules for cardinality and conformance statements, and promote proper exchange of C-CDA documents. There is a 90-day delay from the time the CCG has been updated with the ONC-approved corrections to when compliance with the corrections will be required to pass testing. Similarly, there will be an 18-month delay before a finding of a correction’s absence in certified health IT during surveillance would constitute a non-conformity under the Certification Program.
  • Version: HL7^® IG for CDA^© Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1, October 2017. Effective for testing on February 04, 2021. Surveillance compliance date on May 06, 2022.
• Mapping to the North American Association of Central Cancer Registries (NAACCR) format is not included in the IG because the mapping rules are complex and can change over time based on continued input and refinement by the cancer registry community. It is ONC's understanding that the CDC will work closely with the cancer registry community to develop mapping rules for the IG and will incorporate the rules into the software tools CDC provides state cancer registries. In regard to concerns expressed about jurisdictional variations, all public health jurisdictions have adopted the HL7^® IG Release 1 for cancer reporting and will be moving to the updated version published by the CDC. [see also 80 FR 62666]
• The CDC National Program of Cancer Registries (NCPR), and the North American Association of Central Cancer Registries (NAACCR), no longer require state cancer registries to collect “Stager Clinical Cancer” and “Stager Pathologic Cancer” (also referred to as “Staged By”) data elements for cases diagnosed in 2018 or later. For testing of this criterion, ONC will allow for any valid value in the specified value set to be provided for the “Stager Clinical Cancer” and “Stager Pathologic Cancer” elements.

Technical outcome – The health IT can create cancer case information for electronic transmission using, at a minimum, the March 2022 Release of the U.S. Edition of SNOMED CT^® and Version 2.76 of LOINC^®.

Clarifications:

• ONC provides the following object identifiers (OIDs) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
  • SNOMED CT^® OID: 2.16.840.1.113883.6.96
  • LOINC^® OID: 2.16.840.1.113883.6.1 [see also 80 FR 62612]
• Health IT Modules can present for certification to a more recent version of SNOMED CT^®, and LOINC^® than what is outlined in regulation per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62620]