Da Vinci - Coverage Requirements Discovery
2.2.0-ballot - STU 2.2 Ballot United States of America flag

This page is part of the Da Vinci Coverage Requirements Discovery (CRD) FHIR IG (v2.2.0-ballot: STU 2.2 Ballot) based on FHIR (HL7® FHIR® Standard) R4. This version is a pre-release. The current official version is 2.1.0. For a full list of available versions, see the Directory of published versions

CRD IG Home Page

Official URL: http://hl7.org/fhir/us/davinci-crd/ImplementationGuide/hl7.fhir.us.davinci-crd Version: 2.2.0-ballot
IG Standards status: Trial-use Maturity Level: 4 Computable Name: CoverageRequirementsDiscovery
Other Identifiers: OID:2.16.840.1.113883.4.642.40.18

Welcome to the ballot for the STU 2.2 release of CRD.

This release contains many changes requested by the implementer community. Most of them are non-significant or backwards compatible changes, but there are a few that could at least be theoretically breaking for some implementations and there are a few that will be breaking for all implementations. A complete list of the changes for this ballot, as well as links to the tracker items that provide justification for them can be found here

Not all issues raised against the specification are resolved prior to this ballot. There are a few issues that call into question some of the fundamental design approaches associated with the guide. The community has been engaged in deep discussions about these issues and feedback from the community is sought by the community about the issues raised. It is possible that changes resulting from some of these issues could be incorporated in the publication that results from these issues. A list of the issues, considerations around the issues, and associated Jira tickets may be found here.

This ballot also includes notes related to two Jira issues that are not fully reflected in this release:

  • FHIR-50276 updates the guide to adhere to an HL7 policy requiring a transition of code systems from 'temporary' codes to official codes maintained outside of the implementation guide now that the requirements are more stable. The proposals to add the official codes are not yet available but will be before the publication of the guide. Once they are available, the guide will be updated to have two bindings for the relevant data elements, requiring both the old and new codes to be present. This will provide a transition path for those using older versions of the specification. Support for the temporary codes will be phased out in a future release. The specific value sets impacted are: Coverage Assertion Reasons and CRD Coverage Detail Codes (used in the Coverage Information extension CRD Card Types (used in the CRD configuration mechanism), and CMS Location Codes (used in the CRD Location profile),
  • FHIR-50814 - as part of improving the validation process to catch the identified issues (and others), there is work to define a set of computable representations for the CRD-specific CDS Hooks request and response models. Tooling issues are currently preventing this set of representations from being complete (and thus actually performing validation). If these tooling issues are addressed prior to publication, then computable representations of CRD-specific constraints will be included in the IG.
IMPORTANT: The scope of this ballot is limited to the above changes and to feedback about the issues linked to above. While feedback can always be submitted against any content in the specification at any time, votes submitted against content that is outside the official scope of the ballot may be deemed 'not related' and therefore not able to support negative votes.

This STU update of the specification reflects several changes based on implementer feedback about the Coverage Requirements Discovery (hereafter, CRD) specification arising from detailed review, connectathons and implementation experience. "STU notes" call out additional key considerations where feedback is desired.

This specification is a Standard for Trial Use. It is expected to continue to evolve and improve through connectathon testing and feedback from early adopters.

Feedback is welcome and may be submitted through the FHIR change tracker indicating "US Da Vinci CRD" as the specification.

This implementation guide is dependent on other specifications. Please submit any comments you have on these base specifications as follows:

  • Feedback on CDS Hooks should be posted to the FHIR change tracker with "CDS Hooks" as the specification.
  • Feedback on the FHIR Core specification should be submitted to the FHIR change tracker with "FHIR Core" as the specification.
  • Feedback on the US Core profiles should be submitted to the FHIR change tracker with "US Core" as the specification.

Individuals interested in participating in the Coverage Requirements Discovery implementation guide project or other HL7 Da Vinci projects can find information about Da Vinci [here](http://www.hl7.org/about/davinci).

A summary of the major changes from the previous release can be found here.

Overview

The process of billing a patient's insurance provider is complex and costly, particularly in the United States. Healthcare providers work with a range of payers who provide coverage for the products and clinical services provided to patients. Each payer offers distinct insurance plans for healthcare products and services, and each has its own unique process to determine whether each service is necessary and appropriate. These processes have many different requirements for documentation, prior authorization, or other approval steps. Claims submitted for payment that do not meet payer requirements will typically be denied, which may result in service delay, resubmission, or appeal. These delays and additional processes may result in negative health outcomes or financial costs for patients, as well as financial and productivity losses for providers.

This Coverage Requirements Discovery (CRD) implementation guide defines a workflow in which a payer makes coverage requirement information available to a healthcare provider within the provider's software system at the point of care where treatment decisions are made. This will help clinicians and administrative staff make informed recommendations to their patients and meet payer submission requirements.

This implementation guide supports both Protected Health Information (PHI)-specific and non-PHI mechanisms for CRD to meet the needs and privileges of different payer organizations. These mechanisms will allow payers to share a wide variety of information with providers in a context-sensitive manner including:

  • updates to coverage information
  • alternative (e.g. first-line, lower-cost, etc.) services or products
  • documentation requirements and rules related to coverage
  • forms and templates to complete
  • indications of whether a therapy is covered and if prior authorization is required, including propagating this information into the relevant order/appointment

This implementation guide is designed to allow for initial support of basic capabilities and to subsequently build new features over time.

The scope of this specification has increased to also support prior authorization process earlier in the workflow by allowing prior authorization to be returned during the CRD interaction. Specifically:

On Feb 28, 2024, the Office of Burden Reduction and Health Informatics (OBRHI) National Standards Group (NSG) announced an enforcement discretion that they would not enforce the requirement to use the X12 278 for prior authorization if the covered entities were using the FHIR-based Prior Authorization API as described in the CMS Interoperability and Prior Authorization final rule (CMS-0057-F). This allows payers to return a prior authorization number for use in the X12 837 in coverage extension of the CRD and DTR IGs or as part of the all-FHIR exchange of the Prior Authorization Response Bundle in the PAS IG. For CRD, this specifically means that the satisfied-pa-id in the Coverage Information extension can be used as an X12 prior authorization number.

Systems

This implementation guide sets expectations for two types of systems:

CRD clients are typically systems that healthcare providers use at the point of care, including electronic medical records systems, pharmacy systems, and other provider and administrative systems used for ordering, documenting, and executing patient-related services. Users of these systems need coverage requirements information to support care planning.

Examples of potential CRD clients include EHRs, EMRs, practice management systems, scheduling systems, patient registration systems, etc.

The CRD client may actually involve multiple systems. For example, the systems that handle order entry may be different from what is used for appointment booking and different again from the system that exposes information over the FHIR interface. It is possible that a provider environment might use an intermediary to coordinate CRD client calls from multiple systems. Such an architecture is sufficient provided that:

  • Calls are triggered from within the system the user is interacting with at the time when the 'hook event' (entering an order, booking an appointment, etc.) occurs.
  • Cards returned are displayed to the user, or in the event of system actions, user-notifications associated with the system actions are presented to the user within the same application.
  • The 'access token' and FHIR endpoint exposed to the CRD service has access to all relevant data, independent of which physical data store it resides.
  • The intermediary could take responsibility for the FHIR interface, such as determining which payer should receive a coverage request.

There are three distinct sets of capabilities for CRD clients, one for USCDI v1 (US-Core 3.1.1), one for USCDI v3 (US-Core 6.1.0), and one for USCDI v4 (US-Core 7.0.0). Typically, a client would support only one of these, based on which US Core release the client supports internally. There is a single CRD server set of capabilities which must be able to handle data from any of the three supported USCDI versions.

When CRD clients are made up of multiple systems, there will be orchestration requirements to allow each system to interact in a way that together they appear as a single monolithic system from the perspective of the CRD server. This IG provides some discussion of this on the electronic prior authorization (ePA) Coordinators page, though it does not yet provide any standardization about how components should interoperate to achieve the intended monolithic behavior. If there is industry interest, future releases of this IG may work to standardize some of these "intra-client" interactions.

CRD servers (or servers) are systems that act on behalf of payer organizations to share information with healthcare providers about rules and requirements related to healthcare products and services covered by a patient's health plan. A CRD server will provide coverage information related to one or more insurance plans. CRD servers are a type of CDS service as defined in the CDS Hooks Specification.

There are is a single set of capabilities for CRD servers that spans USCDI v1 (US-Core 3.1.1) USCDI v3 (US-Core 6.1.0), and USCDI v4 (US-Core 7.0.0) expectations. Payers will need to handle content from any of the releases, as CRD clients will be transitioning support for the versions at different times - and in some cases may provide content that spans a mixture of versions.

Content and Organization

This implementation guide (and the menu for it) is organized into the following sections:

  • Background - Supporting informative pages that do not set conformance expectations
    • Reading this IG points to key pages in the FHIR spec and other source specifications that must be understood to understand this guide
    • Use Cases describes the intent of the implementation guide, gives examples of its use, and provides a high-level overview of expected process flow
    • Project and Participants gives a high-level overview of Da Vinci and identifies the individuals and organizations involved in developing this implementation guide
    • Burden Reduction identifies related specifications this implementation guide builds upon that developers should read and understand prior to implementing this specification
    • ePA Coordinators acknowledges that neither the payer nor provider systems involved in CRD are monolithic and shows how the various components of provider and payer systems might interact with "ePA Coordinator" systems to satisfy the requirements of this IG
  • Specification - Pages that set conformance expectations
    • Conformance Expectations defines base language and expectations for declaring conformance with the guide
    • Privacy, Safety, and Security covers considerations around data access, protection, and similar concepts that apply to all implementations
    • Foundational Guidance covers high-level conformance expectations that apply to all implementations
    • Deviations and Enhancements covers detailed implementation requirements and conformance expectations that are independent of specific hooks or cards
    • Supported Hooks identifies the expectations for support for specific CDS hooks
    • Hook Response Profiles defines patterns for CDS Hooks cards and system actions that can be returned as part of this specification
    • Implementation Guidance provides recommendations for implementation that fall outside the technical scope of the specification
    • CRD Metrics provides a logical model describing how to capture data that may be relevant to measuring or reporting on CRD use
  • FHIR Artifacts
    • Artifacts Overview introduces and provides links to the profiles, search parameters and other FHIR artifacts used in this implementation guide
    • Additional links point to complete lists of all artifacts defined in this guide as well as ancestor guides
  • Base Specifications - Quick links to the various specifications this guide derives from
  • Support - Links to help with use of this guide
    • Discussion Forum is a place to ask questions about the guide, discuss potential issues, and search through prior discussions
    • Project Home includes information about project calls, agendas, past minutes, and instructions for how to participate
    • Implementer Support provides information about reference implementations, resources for testing, known errata, regulatory considerations, and practical implementation pathways
    • Project Dashboard shows new and historical issues that have been logged against the specification, proposed dispositions, unapplied changes, etc.
    • Propose a Change allows formal submission of requests for change to the specification. (Consider raising the issue on the discussion forum first.)
    • Downloads allows downloading this and other specifications, as well as other useful files

Dependencies

This guide is based on the FHIR R4 specification that is mandated for use in the U.S. as well as the CDS Hooks 2.0 and CDS Hooks CI Build releases of the CDS Hooks specification. It also leverages the SMART on FHIR specification for CRD clients that opt to use that approach for "what-if" scenarios.

In addition, this guide also relies on several ancestor implementation guides:

Implementation GuideVersion(s)Reason
CDS Hooks2.0.1

The CDS Hooks specification the CRD architecture is based on

CDS Hooks Library1.0.1

Provides the hook definitions for CDS Hooks

Da Vinci Health Record Exchange (HRex)1.1.0

Defines common conformance rules across all Da Vinci IGs, as well as additional constraints and profiles beyond U.S. Core

FHIR Extensions Pack5.3.0-ballot-tc1

Automatically added as a dependency - all IGs depend on the HL7 Extension Pack

5.2.0Imported by HL7 Terminology (THO) (and potentially others)
5.1.0Imported by Da Vinci Health Record Exchange (HRex) (and potentially others)
FHIR R4 package : Core4.0.1Imported by HL7 Terminology (THO) (and potentially others)
FHIR Tooling Extensions IG0.8.0

Defines the CDS Hooks logical models

HL7 Terminology (THO)6.5.0

Automatically added as a dependency - all IGs depend on HL7 Terminology

6.2.0Imported by CDS Hooks (and potentially others)
6.1.0Imported by Da Vinci Health Record Exchange (HRex) (and potentially others)
5.5.0Imported by US Core (and potentially others)
Public Health Information Network Vocabulary Access and Distribution System (PHIN VADS)0.12.0Imported by US Core (and potentially others)
SMART App Launch2.0.0Imported by US Core (and potentially others)
Structured Data Capture3.0.0

Defines expectations for Questionnaires prompted by cards

US Core7.0.0

Defines USCDI v4 EHR expectations on a range of resources that will be passed to and/or queried by CRD servers.

6.1.0

Defines USCDI v3 EHR expectations on a range of resources that will be passed to and/or queried by CRD servers

3.1.1

Defines USCDI v1 EHR expectations on a range of resources that will be passed to and/or queried by CRD servers.

Value Set Authority Center (VSAC)0.19.0

Uses the latest version of the VSAC codes

0.18.0Imported by US Core (and potentially others)

This implementation guide defines additional constraints and usage expectations above and beyond the information found in these base specifications.

Intellectual Property Considerations

This implementation guide and the underlying FHIR specification are licensed as public domain under the FHIR license. The license page also describes rules for the use of the FHIR name and logo.

This publication includes IP covered under the following statements.