The following reference(s) are associated with this entry:
| Policy |
Standards Version Advancement Process
|
ONC |
The Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the “Real World Testing” Condition and Maintenance of Certification requirement (§ 170.405) of the 21st Century Cures Act.
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All the standards in this guidance are currently available for voluntary certification under the Certification Program. The authorized SVAP versions for 2020 went into effect in the Certification Program beginning March 12, 2021. The 2022 authorized SVAP versions were announced June 28, 2022 and went into effect on August 29, 2022. Once effective, any newer versions of authorized standards replaced existing authorized standards from previous years. |
| Best Practice |
CMS Implementation Guide for Quality Reporting Document Architecture Category I Hospital Quality Reporting Implementation Guide for 2022
|
Centers for Medicare and Medicaid Services |
This guide is a CMS Quality Reporting Document Architecture Category I (QRDA I) implementation guide to the HL7 Implementation Guide for CDA Release 2: Quality Reporting Document Architecture Category I, Release 1, STU Release 5.2, and any subsequent errata
update, referred to as the HL7 QRDA I STU R5.2 in this guide. This guide describes additional conformance statements and constraints for EHR data submissions that are required for reporting information to the CMS for the Hospital Inpatient Quality Reporting Program 2022 Reporting Period.
The purpose of this guide is to serve as a companion to the base HL7 QRDA I STU R5.2 for entities such as Eligible Hospitals (EH), Critical Access Hospitals (CAHs), and vendors to submit QRDA I data for consumption by CMS systems including for Hospital Quality Reporting (HQR).
Each QRDA Category I report contains quality data for one patient for one or more quality measures, where the data elements in the report are defined by the particular measure(s) being reported on. A QRDA Category I report contains raw applicable patient data. When pooled and analyzed, each report contributes the quality data necessary to calculate population measure metrics. |
| Best Practice |
CMS Implementation Guide for Quality Reporting Document Architecture Category III Eligible Clinicians and Eligible Professionals Programs Implementation Guide for 2022
|
Centers for Medicare and Medicaid Services |
This guide is a CMS Quality Reporting Document Architecture Category III (QRDA III) implementation guide to the HL7 QRDA III STU R2.1. Templates defined in this implementation guide are conformant with HL7 QRDA III STU R2.1. The CMS Eligible Clinicians and Eligible Professionals Programs QRDA III templates address aggregate reporting requirements for: Primary Care First (PCF), Merit-Based Incentive Payment System (MIPS), APM Performance Pathway (APP)
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A QRDA III report is an aggregate quality report. Each QRDA III report contains calculated summary data for one or more measures for a specified population of patients within a particular health system over a specific period of time. Summary data in the QRDA III report are defined based on the specified measures in HL7 Health Quality Measures Format (HQMF), which standardizes the representation of a health quality measure as an electronic document. Other summary data provided in the QRDA III report include Promoting Interoperability measures, formerly Advancing Care Information measures, and Improvement Activities. |
| Requirement |
170.315(c)(3) Clinical quality measures (CQMs) — report
|
ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule). It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the ONC Cures Act Final Rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed. |
| Requirement |
170.315(c)(1) Clinical quality measures (CQMs) — record and export
|
ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed. |
| Requirement |
170.315(c)(2) Clinical quality measures (CQMs) — import and calculate
|
ONC |
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed. |
| Vendor Provided* |
QRDA - Quality Reporting Document Architecture
|
ONC |
The Quality Reporting Document Architecture (QRDA) is the data submission standard used for a variety of quality measurement and reporting initiatives. It is based on the Health Level Seven International® (HL7®) Clinical Document Architecture (CDA). QRDA creates a standard method to report quality measure results in a structured, consistent format and can be used to exchange eCQM data between systems. |
| Policy |
170.205(h) Clinical quality measure data import, export and reporting - Standards (2) and (3)
|
Code of Federal Regulations |
HL7 CDA R2 Implementation Guide: Quality Reporting Document Architecture—Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1—Introductory Material
HL7 CDA R2 Implementation Guide: Quality Reporting Document Architecture—Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 2—Templates and Supporting Material (incorporated by reference in § 170.299).
CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020 (incorporated by reference in § 170.299). |
| Policy |
170.205(k)(3) Clinical quality measure aggregate reporting
|
Code of Federal Regulations |
CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020 (incorporated by reference in § 170.299) |
| Policy |
170.315(c)(1) - Clinical quality measures (CQMs) — record and export
|
Code of Federal Regulations |
Record. For each and every CQM for which the technology is presented for certification, the technology must be able to record all of the data that would be necessary to calculate each CQM. Data required for CQM exclusions or exceptions must be codified entries, which may include specific terms as defined by each CQM, or may include codified expressions of “patient reason,” “system reason,” or “medical reason.”
Export. A user must be able to export a data file at any time the user chooses and without subsequent developer assistance to operate:
(A) Formatted in accordance with the standard specified in § 170.205(h)(2);
(B) Ranging from one to multiple patients; and
(C) That includes all of the data captured for each and every CQM to which technology was certified under paragraph (c)(1)(i) of this section. |
| Policy |
170.315(c)(2) - Clinical quality measures (CQMs) — import and calculate
|
Code of Federal Regulations |
Import. Enable a user to import a data file in accordance with the standard specified in § 170.205(h)(2) for one or multiple patients and use such data to perform the capability specified in paragraph (c)(2)(ii) of this section. A user must be able to execute this capability at any time the user chooses and without subsequent developer assistance to operate.
Calculate each and every clinical quality measure for which it is presented for certification. |
| Policy |
170.315(c)(3) - Clinical quality measures (CQMs) — report
|
Code of Federal Regulations |
Enable a user to electronically create a data file for transmission of clinical quality measurement data:
In accordance with the applicable implementation specifications specified by the CMS implementation guides for Quality Reporting Document Architecture (QRDA), category I, for inpatient measures in § 170.205(h)(3) and CMS implementation guide for QRDA, category III for ambulatory measures in § 170.205 (k)(3); or
In accordance with the standards specified in § 170.205(h)(2) and § 170.205(k)(1) and (2) for the period before December 31, 2022. |
| Policy |
Information Blocking (21st Century Cures Act)
|
ONC |
Most clinical information is digitized, accessible, and shareable thanks to several technology and policy advances making interoperable, electronic health record systems widely available. In 2016, the 21st Century Cures Act (Cures Act) made sharing electronic health information the expected norm in health care by authorizing the Secretary of Health and Human Services (HHS) to identify `reasonable and necessary activities that do not constitute information blocking.` ONC``s 2020 Cures Act Final Rule established information blocking exceptions to implement the law. |
| *NOTE: Vendor provided information is subject to the accuracy of the manufacturer. |
