Meaningful Use

Stage 2 Meaningful use has added two new measures for EPs related to public health registries. The first relates to submission of cancer diagnoses to public health maintained central cancer registries which is mandatory in most states. The second relates to submission of data to other, unspecified specialized public health registries maintained by public health agencies or national specialty societies (specialized registries operated by patient safety organizations and quality improvement organizations also qualify).

With the advent of Stage 3, these measures are being combined into a single measure relating to “specialized registries” which include both public health registries (those administered by a local, state, or national public health agency) and clinical data repositories (those managed by other types of organizations or associations). EPs (only) can continue to be able to report to Cancer Registries. Starting in Stage 3 (2018), EH/CAHs will be able to report Hospital-associated infections, and EP/EH/CAH will be able to participate in national healthcare surveys. State, local and Federal registries can all be offered under meaningful use (for example, a state-level prescription drug monitoring program registry).

An EP can be excluded from these measures if it does not treat patients relevant to the disease captured in the registry, if the public health agency cannot accept data in the specified standard and no other entity has been designated to do so on its behalf (like an HIE), if the public health agency does not indicate its capability to collect data, or if the public health agency is not capable of enrolling the EP in a timely way for additional information see CMS FAQ).

Though the infrastructure to support HIEs is still developing, there is an expectation that as the program proceeds expectations for submission of syndromic surveillance information to public health agencies via HIE will increase.

Technical Standards

The Final Rule for Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology (August, 2012) identifies the following standards for cancer data exchange which continue to be valid for the Module Period as well as (optionally) for the 2017 Stage 3 Option Year:

§ 170.205 Content exchange standards and implementation specifications for exchanging electronic health information
(i):Cancer information. Standard. HL7 Clinical Document Architecture (CDA), Release 2.0, Normative Edition (incorporated by reference in § 170.299).Implementation specifications. Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA), (incorporated by reference in § 170.299).

During the Module Period, other public health registries (referred to as “specialized registries” in the Stage 2 rule) can continue to be offered for Meaningful Use even though there may not be standards identified in the ONC Rule to support interoperability to them. If participants are in production with these other public health registries as Stage 3 begins these registries can continue to be offered and the participants are considered to be grandfathered; however once Stage 3 begins the public health registry must support standards explicitly included in ONC rulemaking for new participants.

For Stage 3 (in 2018, and also optionally if begun early in 2017), the ONC 2015 Edition Health Information Technology (Health IT) Certification Criteria (October, 2015) identified the following standards for Cancer Registry reporting:

(i) Cancer information–(1) Standard. HL7 Clinical Document Architecture (CDA), Release 2.0, Normative Edition (incorporated by reference in § 170.299). Implementation specifications. Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA), Release 1.0 (incorporated by reference in § 170.299).

(2) Standard. HL7 Clinical Document Architecture (CDA), Release 2.0, Normative Edition (incorporated by reference in § 170.299). Implementation specifications. HL7 CDA© Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1; DSTU Release 1.1, Volume 1 — Introductory Material and HL7 CDA Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1; DSTU Release 1.1 (US Realm), Volume 2 — Templates and Supporting Material (incorporated by reference in § 170.299).

For Hospital-associated infections,

(r) Public health — antimicrobial use and resistance information–(1) Standard. The following sections of HL7 Implementation Guide for CDA Release 2 7mdash; Level 3: Healthcare Associated Infection Reports, Release 1, U.S. Realm (incorporated by reference in § 170.299). Technology is only required to conform to the following sections of the implementation guide:
(i) HAI Antimicrobial Use and Resistance (AUR) Antimicrobial Resistance Option (ARO) Report (Numerator) specific document template in Section 2.1.2.1 (pages 69-72);
(ii) Antimicrobial Resistance Option (ARO) Summary Report (Denominator) specific document template in Section 2.1.1.1 (pages 54-56); and
(iii) Antimicrobial Use (AUP) Summary Report (Numerator and Denominator) specific document template in Section 2.1.1.2 (pages 56-58).

And for health care surveys:

(s) Public health — health care survey information–(1) Standard. HL7 Implementation Guide for CDA Release 2: National Health Care Surveys (NHCS), Release 1 — US Realm, HL7 Draft Standard for Trial Use, Volume 1 — Introductory Material and HL7 Implementation Guide for CDA Release 2: National Health Care Surveys (NHCS), Release 1 — US Realm, HL7 Draft Standard for Trial Use, Volume 2 — Templates and Supporting Material (incorporated by reference in § 170.299).

For Stage 3 the public health registry must support standards explicitly included in ONC rulemaking for new participants (ongoing participants in production during a previous stage can continue to interoperate with that registry).

Testing Procedures

The National Institute of Standards and Technology (NIST) has provided a guidance document and testing tools (see right panel) for ensuring that certified EHR systems can properly send cancer registry data.