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General Guidance

Introduction

Clinical Quality Measures are a common tool used throughout healthcare to help evaluate and understand the impact and quality of the care being provided to an individual or population.

The Data Exchange for Quality Measure (DEQM) Implementation Guide defines the interactions for two purposes in the Quality Measure Ecosystem. The first interaction is when a Producer, such as a practitioner, or owner of data needs to exchange that data with a Consumer of that data, such as a payer, a registry or public health. We call this the Data Exchange Scenario. Examples of this interaction might be when a provider has patient information from a recent visit that he needs to share with a payer under a value based contract. There may also be use cases where the Producer in this scenario is a Payer and needs to exchange data with a Provider.

The second scenario defined in this guide is when a Reporter needs to exchange a measure report with a Receiver. This guide addresses the Individual Measure Reporting and the Summary Reporting. As an example, Individual Measure Reports may be used by hospitals acting as the Reporter to report a specific measure to a payer acting as a Receiver. Similarly, Summary Measure Reports may be used to report yearly eCQM results on a specific measure.

This version of the guide adds the Gaps in Care Reporting Scenario. The Gaps in Care Reporting is used to report the open and/or closed gaps for quality measures over a gaps through period specified by a Client. Optionally, it is also used to report details to the open gaps identified and mitigation steps for addressing them. It further provides capability of associating clinical data included in the report with the population criteria (i.e. denominator, numerator) of a measure that they apply to.

Patient List Reporting is a third reporting type which is similar to a QRDA Category 2 report. This Type is out of scope for this version of the Implementation Guide. In a future version this guide, Patient List Reporting will be addressed.

Preconditions and Assumptions

• Although the exact mechanisms for securing these exchanges are not specified as part of this implementation guide:

  • Exchanges are limited to mutually agreed upon (i.e., between the Producer and Consumer) patients list or population.

  • Systems should use standard authentication and authorization approaches. The SMART App Launch and SMART backend services authentication/authorization approach are recommended models.

• The Measure resource is used to provide both human- and machine-readable definitions of a quality measure

• The MeasureReport provides an association to a specific quality measure and links the submitted data together to simplify processing for the receiver.

• It is the responsibility of the Producer to ensure that measure data is present in a structured, retrievable form.

• The required data is represented in the referenced resources defined by the MeasureReport.

  • Multiple MeasureReport may reference the same instance of a resource.

• Both Consumers and Producers should use a common clinical quality language (CQL) that would allow the same measures to be applied in healthcare and at the aggregator. This would also enable the application of the same measures across populations that span multiple Consumers (such as payers). Using common measures across payers reduces development burden for FHIR implementers.

DEQM MeasureReport Profiles

The MeasureReport resource is used as an organizer for both the Data Exchange Scenario and for measure reporting scenario. To meet the different needs in these scenarios, DEQM has created 3 MeasureReport profiles. Technically the type of profiles can be determined by inspecting the meta.profile element if present or the type element.

The MeasureReport resource is also used for the Gaps in Care Reporting Scenario. A DEQM MeasureReport profile defined in this guide is used to support the needs of Gaps in Care Reporting.

Data Exchange

The DEQM Data Exchange MeasureReport Profile is used to get the data from the producer to a consumer of the data. The consumer might be a system that calculates the measure report but they could also be an aggregator who sends that data on to another system to do measure calculation and reporting. Along with Data-Exchange MeasureReport Profile, the data producer sends the Organization, Patient and any relevant resources for the measure they have produced data on. When a data producer, such as a practitioner, sends a MeasureReport bundle, they may not have all the data that is required to calculate the measure report. One example might be because the measure requires outcome data from at a later point in time during the measurement period. Another example where the data producer may not have all the data would be continuous coverage period as the producer of the data may not know the patient was covered on the day the patient was seen. The Consumer (in this case the payer as aggregator) is the owner of all coverage information. Therefore, only the consumer could determine if the continuous coverage period requirement is met.

Measure Reporting

Measure Reporting is done by a Reporter who has all of the data that is required to generate a report(s). Two profiles for measure reporting have been defined in this guide.

The DEQM Individual MeasureReport Profile is used when a measure is reported for a specific patient. It contains all of the data that is relevant to generate the report including the measure outcome and is similar to a QRDA Category 1 report. The MeasureReport(s) are packaged in a FHIR Bundle with Organization, Patient and any other resources that were used to calculate this measure.

The DEQM Summary MeasureReport Profile is used when a measure is reported for a group of patients at the conclusion of a measure measurement period. It includes the measure outcome data and is similar to a QRDA Category 3 report. Unlike the DEQM Individual MeasureReport Profile, the report is typically transacted as a single MeasureReport report. Although several Summary reports may be transacted together as Bundle.

Data Quality

The default profiles in this implementation guide provide a baseline for data validation, but note that additional validation criteria may be expressed via Measure specific profiles. The profiles expected by the CQL will be referenced in the retrieve expressions of the logic, and surfaced as profile elements of the data requirements. These references to profiles used by the CQL script are expected to be used for data quality, data integrity checks, and data validation. Data access layers providing resources to a CQL engine are expected to supply resources that conform to the stated profiles.

Gaps in Care Reporting

Gaps in Care Reporting can be requested by a Client to a Server system that has all of the data that is known about the patient(s) at a point in time during a gaps through period. The care-gaps operation is used to request and receive Gaps in Care Report for measures.

When the care-gaps operation is run on the Server, it returns a FHIR Bundle for each patient. The bundle conforms to the DEQM Gaps In Care Bundle Profile, which must contain a Composition that uses the DEQM Gaps In Care Composition Profile. The DEQM Gaps In Care Composition references one to many MeasureReport resource; each MeasureReport is for a single measure and conforms to the DEQM Individual MeasureReport Profile. Optionally, the actual individual MeasureReport resources referenced are also packaged in the same DEQM Gaps In Care Bundle, along with Patient, Organization, and other resources that were used to calculate this measure. A DetectedIssue resource defined using the DEQM Gaps In Care DetectedIssue Profile must be included to indicate gap status of that measure via the DEQM Gap Status Extension, a modifier extension.

The DEQM Individual MeasureReport contains all of the data that is relevant to calculate the report including the measure outcome and indication of open gaps. The care-gaps operation determines the gaps status for the patient for a specific measure based on the measureScore data contained in the MeasureReport. Depending on what input parameters are provided to the care-gaps operation for generating a Gaps in Care Report, a DEQM Gaps In Care Composition may contain reports for measures with only open gaps, only closed gaps, or both open and closed gaps. The DEQM Population Reference Extension to the evaluatedResource is added to the DEQM Individual MeasureReport Profile to support associating an evaluated resource with a specific measure population or populations that it applies to. For example, a colonoscopy procedure done for an individual 5 years ago is used to meet the numerator population criteria when evaluating the colorectal cancer screening measure for the individual. Through the use of this DEQM Population Reference Extension, the Server can indicate this colonoscopy procedure data was used for evaluating the numerator population, identified by the population group id for numerator specified in the Colorectal Cancer Screening Measure resource.

Default Profiles Used in the Evaluation of a Measure

Depending on the specific Measure and Interaction, Default Profiles from DEQM, QI Core, and CQFM are used in the evaluation of a measure and referenced by a MeasureReport. These profiles apply to any resource that does not otherwise have an explicit profile assigned by the implementation guide. Note that several DEQM Profiles are derived from QI Core profiles and are used as the default instead of the corresponding QI Core profile. Refer to the QI Core implementation guide for examples of how to represent data involved in calculation of quality measures.

QI Core Practitioner, QI Core Organization, and QI Core Coverage profiles have replaced respective DEQM specific profiles and are used to model reporters and participating practitioners and organizations. </div>

Negation Patterns for Quality Measures

​Refer to the Quality Measure Implementation Guide for guidance on negation patterns in quality measurements. Note that implementations processing negated data may not be returned with a single code, but rather a value set identifier represented by the Not Done Value Set which are part of the QI Core profiles, and should consider data with the appropriate value set identifier as satisfying the criteria for value set membership. The negation pattern for the MedicationRequest (MedicationNotRequested) resource is demonstrated in the Single Indv Vte Report Option 7 example. </div> The negation patterns described here are about approaches for identifying when events are not present or when events are documented as not occurring for a reason. These patterns may appear throughout a measure in any of the various population criteria, depending on measure intent. For example, the absence of a particular medication may be grounds for membership in the initial population, denominator, numerator, or an exclusion or exception criteria, depending on how the measure is constructed. An example of this is the VTE-1 USE Case Option 7.

Using Contained Resources in the Response Transaction

Contained resources SHOULD NOT be used when responding to the submit-data or collect-data operation or to the Individual reporting transactions. The data exchange transaction payloads are Parameters resources containing resource parameters. The response to the individual reporting transactions are Bundles. The only time contained resource can be used is when the source data exists only within the context of the transaction. For example, if the only information about the patient’s coverage is the payor name, the Coverage resource could be contained by the Patient resource:

{
  "resourceType": "Patient",
  "id": "patient01",
  "contained": [
    {
      "resourceType": "Coverage",
      "status": "active",
      "beneficiary": {
        "reference": "#"
      },
      "payor": [
        {
          "reference": "Organization/organization04"
        }
      ]
    }
  ]
  ...<rest of patient resource>
}

Contained resources SHOULD NOT be used when responding to the care-gaps operation.

Must Support

Certain elements in the profiles defined in this implementation guide are marked as Must Support. This flag is used to indicate that the element plays a critical role in defining and sharing quality measures, and implementations SHALL understand and process the element.

In addition, because this specification makes use of data implementation guides (e.g. US Core, QI-Core), the implications of the Must Support flag for profiles used from those implementation guides must be considered.

For more information, see the definition of Must Support in the base FHIR specification.

Must Support guidance here requires additional clarifications, we are seeking implementer feedback on what type of guidance would be most useful.