Additional 2016 QRDA Guidance

How should single administrations be sent to satisfy CONF:1098-7508 for 2016 Reporting Period submissions?

Issue: Table 132 for Medication Activity (V2) in the HL7 QRDA Category I Release 1 DSTU Release 3 (June 2015) defines the effectiveTime element (i.e. CONF:1098-7508) as being of data type IVL_TS. As such, a substanceAdministration/effectiveTime/@value is not allowed and the CMS receiving system will reject any QRDA-I submission with such a construct in it for the Medication Activity (V2) template.

Solution: The Medication Activity (V2) conformance statements and the note providing guidance on how to enter this effectiveTime specifically state that the correct way to specify a single administration of a medication is by entering a single time in substanceAdministration/effectiveTime/@value, however, due to the restrictions enforced on IVL_TS data types, for the 2016 reporting period submissions, the proper way to enter a single administration medication is to put the exact same time value that would have gone into substanceAdministration/effectiveTime/@value into both substanceAdministration/effectiveTime/low/@value and substanceAdministration/effectiveTime/high/@value.


What are all of the reporting strata for CMS137v4 and CMS155v4?

Please note that the following reporting strata are absent from Table 47 in the 2016 CMS QRDA Implementation Guide Appendix for


Reporting Stratum 2-1


Reporting Stratum 2-2



Reporting Stratum 2-1


Reporting Stratum 2-2


Reporting Stratum 3-1


Reporting Stratum 3-2


The table below lists the Version Specific Measure Identifier, the population identifiers, and the identifiers for reporting strata for CMS137v4 and CMS155v4.

Table llists the Version Specific Measure Identifier, the population identifiers, and the identifiers for reporting strata for CMS137v4 and CMS155v4

QRDA ONC JIRA Ticket: QRDA-364 & QRDA-406

There is a minor typo in the 2016 HQR and PQRS Schematrons:

In general, the context path is missing a closing bracket ‘]’ at the beginning (see the attached file in JIRA QRDA-365 for details).The changes have been made to the schematron files; however, this typo does not warrant a new Schematron release. Please see below for the list of the patterns that need to have a closing bracket for their context:  

  • <sch:pattern id="US-Realm-Address-pattern-errors"> 
  • <sch:pattern id="US-Realm-Address-pattern-warnings"> 
  • <sch:pattern id="US-Realm-Person-Name-pattern-errors"> 

Given the issue if you do not strictly follow the IG the error may not be caught during the validation but it should not prevent the file from being accepted and will not affect the measure calculation in any way.


CONF:18177 Should be removed from the 2016 CMS QRDA-III Schematron rules

According to the 2016 CMS QRDA Implementation Guide, CONF:18177 is replaced by CONF:711167. However, both conformance statements exist in the 2016 CMS QRDA-III Schematron file. As a result, the submitter may receive two errors instead of only one if the submitter violates that constraint rule that is described below:  

This assignedEntity SHALL contain exactly one [1..1] id (CONF:711167) such that it


How does the PQRS system determine in a QRDA-I file if a patient is a Medicare patient and therefore HIC number is required?

All Medicare beneficiaries are assigned a HIC number.  The PQRS system determines whether a patient is a Medicare patient based on the Source of Payment Typology (SOP) code submitted in the Patient Characteristic Payer template. If any of the Patient Characteristic Payer templates includes any of the SOP code listed below, then the HIC number is required for this patient in a QRDA-I file submission to the PQRS system.

11 Medicare (Managed Care) 
111 Medicare HMO 
112 Medicare PPO 
113 Medicare POS 
119 Medicare Managed Care Other 
12 Medicare (Non-managed Care) 
121 Medicare FFS 
122 Medicare Drug Benefit 
123 Medicare Medical Savings Account (MSA) 
129 Medicare Non-managed Care Other 
19 Medicare Other

QRDA ONC JIRA tickets: QRDA-236, QRDA-250, QRDA-323.

What is the SEVT processing order for error and warning messages?

For the 2016 reporting period, the PQRS Submission Engine Validation Tool (SEVT) will validate EP submitted files in phases in order to more accurately describe error and warning messages as either violating the base HL7 QRDA standards, 2016 CMS QRDA Implementation Guide specifications, or 2016 PQRS specific rules (PQRS_Pxxxx). Thus, errors and warnings will be generated according to the following hierarchy:

This guidance will be included in the 2017 CMS QRDA Eligible Clinician Implementation Guide.

1) All QRDA files must be valid to the HL7 CDA Schema (CDA_SDTC.xsd). If the submission is not schema valid then the file is rejected and no further validation occurs.

2) Schema valid files are then validated against the 2016 CMS IG Schematron rules which cover the Base 2016 HL7 IG constraints plus the constraints in the 2016 CMS QRDA IG, minus the constraints in the Patient Data Level appendix. 

   a. If errors are encountered (i.e. violations of SHALL constraints) then the file is rejected and no further validation occurs.

3) Submissions that are still valid after the first two phases (but they may include warning from the second phase) then go through a third level of validation occurs. The following User Guides describe the third level of validation for the PQRS program:

   a. There are links to these user guides on the PQRS QualityNet portal. The two relevant guides for this third phase are the following:

     i. PQRS SEVT User Guide (the current version is "Physician Quality Reporting System (PQRS) Program Year 2016 Submission Engine Validation Tool (SEVT) User Manual, Version: 2.0 04/15/2016") and
     ii. PQRS Submissions User Guide (TBD… last year the title was "Physician Quality Reporting System (PQRS), Program Year 2015, Submission User Guide, Version: 2.0, 12/18/2015").

QRDA ONC JIRA ticket: QRDA-325

2016 CMS QRDA Appendix typo corrections:

Text in the 2016 CMS QRDA Appendix (page 90):

This effectiveTime SHALL contain exactly one [1..1] high (CONF:1140-11671). 

  i. This low SHALL contain exactly one [1..1] @value (CONF:PQRS_P0180).


This effectiveTime SHALL contain exactly one [1..1] high (CONF:1140-11671). 

  i. This high SHALL contain exactly one [1..1] @value (CONF:PQRS_P0180).

Text in the 2016 CMS QRDA Appendix (page 65):

SHOULD contain exactly one [1..1] quantity (CONF:1098-7436).

Corrected: SHOULD contain zero or one [0..1] quantity (CONF:1098-7436).

PQRS maintains an errata document to the 2016 CMS QRDA appendix. These corrections have been noted in the errata.

QRDA ONC JIRA tickets: QRDA-303, QRDA-316

What is the allowed precision of a patient’s birthTime in a QRDA-I file for HQR submissions?

The Hospital Quality Reporting (HQR) system only requires that birthTime be precise to at least day, it is acceptable to submit birthTime that is precise to minutes or seconds to HQR. For example, measure PC-05 expects birthTime be precise to minutes or seconds for proper measure calculation.  This is also true for PQRS. However, PQRS has no measures that currently require HHMMSS. 

QRDA ONC JIRA ticket: QRDA-237

What are the QRDA-I submission file size restrictions?

File restriction depends on the program for which the QRDA I file is submitted. File restrictions for HQR and PQRS are given below. Files that do not meet these criteria will be rejected.


  • File size not to exceed 5 MB
  • Number of files per batch not to exceed 15000
  • No encrypted files allowed


  • File size not to exceed 20 MB, whether zipped or not
  • Individual file within the zip when extracted cannot exceed 40 MB

QRDA ONC JIRA ticket: QRDA-291

If a file validation passes PSVA will it be successfully accepted in production?

PSVA only validates the QRDA itself, not the measures data. Passing PSVA validation does not indicate that the submitter has formulated a QRDA that will give them an IPP of 1 or a numerator of 1 for a measure. Although the user may believe the patient has met the numerator or met the IPP, the QRDA has to contain the correct information in it, as well as, the right location in the QRDA file for the Measures Calculations to determine that. We advise you to contact the CMS HQR submission tool help desk at  717-718-1230 extension 105 and submit a ticket for the QualityNet tool to document and track.

QRDA ONC JIRA ticket: QRDA-350

How should value sets be used when submitting data for a specific measure?               

See the 2016 CMS QRDA Appendix for detailed description on how value sets are validated by the PQRS system and the HQR system for QRDA-I and QRDA-III (Page 21).

QRDA ONC JIRA ticket 216 for further reference.