Referral Certification and Authorization Request and Response for Dental, Professional and Institutional Services

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Federally required	Cost	Test Tool Availability
Implementation Specification	ASC X12®N/005010X217 Health Care Services Review—Request for Review and Response (278), May 2006 as an ASC X12 Standards for Electronic Data Interchange Technical Report Type 3	Final	Production	Yes	$	Yes
Implementation Specification	HL7® FHIR® Da Vinci—Coverage Requirements Discovery (CRD) Implementation Guide, Version 2.0.1 – STU 2	Balloted Draft	Production	Yes	Free	Yes
Implementation Specification	HL7 FHIR Da Vinci—Coverage Requirements Discovery (CRD) Implementation Guide, Version 2.2.1 – STU 2.2	Balloted Draft	Production	No	Free	Yes Yes
Implementation Specification	HL7 FHIR Da Vinci—Documentation Templates and Rules (DTR) Implementation Guide, Version 2.0.1 – STU 2	Balloted Draft	Production	Yes	Free	Yes
Implementation Specification	HL7 FHIR Da Vinci—Documentation Templates and Rules (DTR) Implementation Guide, Version 2.2.0 – STU 2.2	Balloted Draft	Production	No	Free	Yes Yes
Implementation Specification	HL7 FHIR Da Vinci Prior Authorization Support (PAS) FHIR Implementation Guide, Version 2.0.1 – STU 2	Balloted Draft	Production	Yes	Free	Yes
Implementation Specification	HL7 FHIR Da Vinci Prior Authorization Support (PAS) FHIR Implementation Guide, Version 2.2.1 – STU 2.2	Balloted Draft	Production	No	Free	Yes Yes
Implementation Specification	HL7 CDA® R2 Implementation Guide: Dental Data Exchange	Balloted Draft	Production	No	Free	Yes
Implementation Specification	HL7 FHIR Da Vinci Da Vinci Clinical Data Exchange Implementation Guide (CDex IG)	Balloted Draft	Pilot	No	Free	No

FFAP icon = Federal FHIR Action Plan: Marks standards for coordinated federal adoption. See Appendix V: Federal FHIR Action Plan for more details.

Federal FHIR Action Plan Alignment
HL7® FHIR® Da Vinci Coverage Requirements Discovery Implementation Guide (CRD IG) This implementation specification provides a framework for payers to share information about coverage requirements with providers, helping facilitate treatment decisions based on a patient’s insurance coverage. This specification is critical for standardizing API-based electronic prior authorization workflows, which aim to reduce delays in patient treatment and alleviate the administrative burden on providers. Developed by the Da Vinci Project Accelerator, the CRD IG is available for implementation without licensing requirements, making it accessible to payers and providers. Payers and providers should consider the CRD IG to streamline the prior authorization process. By automating the exchange of coverage requirements and documentation, this specification reduces the administrative workload associated with assembling and reviewing prior authorization materials. Referenced in Federal Rulemaking: ONC Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) Final Rule; CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) (recommended) HL7® FHIR® Da Vinci Documentation Templates and Rules Implementation Guide (DTR IG) This implementation specification provides a framework for payers to define documentation requirements and provider-specific rules, while enabling providers to automatically submit the necessary documentation via FHIR APIs. This specification is essential for standardizing API-based electronic prior authorization workflows, which aim to reduce delays in patient treatment and alleviate the administrative burden on providers. Developed by the HL7 Da Vinci Project, the DTR IG is available for implementation without licensing requirements, making it accessible to payers and providers. Payers and providers should consider the DTR IG to streamline the prior authorization process. By automating the submission of required documentation, this specification reduces the administrative workload associated with prior authorization. Referenced in Federal Rulemaking: ONC Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) Final Rule; CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) (recommended) HL7® FHIR® Da Vinci Prior Authorization Support Implementation Guide (PAS IG) This implementation specification defines a framework for payer and provider health IT systems to support the submission, receipt, and response to electronic prior authorization requests. This specification is critical for standardizing API-based electronic prior authorization workflows, helping to reduce patient treatment delays and alleviate the administrative burden on providers. Together with the Coverage Requirements Discovery (CRD) IG and Documentation Templates and Rules (DTR) IG, the PAS IG forms a comprehensive solution for streamlining prior authorization processes. Developed by the Da Vinci Project Accelerator, the PAS IG is available for implementation without licensing requirements, making it accessible to payers and providers. Referenced in Federal Rulemaking: ONC Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) Final Rule; CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) (recommended) HL7® FHIR® Da Vinci Da Vinci Clinical Data Exchange Implementation Guide (CDex IG) This Implementation specification provides a framework for data exchange between providers and payers, as well as provider-to-provider and payer-to-payer workflows, for patient EHR data. The CDex IG supports query-based, task-based, and documents-based data exchange workflows. The CDex IG is not intended to replace other HL7 FHIR Da Vinci specifications required by the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F). Instead, it focuses on specific workflows at the provider-payer interface, particularly when there is a need for manual review of received data query requests from external providers or payers. It is important to note that the CDex IG should not be implemented for workflows requiring real-time responses. Instead, it is suitable for scenarios where manual review of data query responses is necessary before delivering the data to partner providers or payers. Certified Health IT developers, providers, and payers are encouraged to consider the CDex IG as a starting point for supporting data exchange at the provider-payer interface. This specification enables controlled and structured data sharing while allowing manual oversight to ensure accuracy and compliance in data exchange workflows.

Federal FHIR Action Plan Alignment

HL7® FHIR® Da Vinci Coverage Requirements Discovery Implementation Guide (CRD IG)

This implementation specification provides a framework for payers to share information about coverage requirements with providers, helping facilitate treatment decisions based on a patient’s insurance coverage. This specification is critical for standardizing API-based electronic prior authorization workflows, which aim to reduce delays in patient treatment and alleviate the administrative burden on providers.
Developed by the Da Vinci Project Accelerator, the CRD IG is available for implementation without licensing requirements, making it accessible to payers and providers.
Payers and providers should consider the CRD IG to streamline the prior authorization process. By automating the exchange of coverage requirements and documentation, this specification reduces the administrative workload associated with assembling and reviewing prior authorization materials.
Referenced in Federal Rulemaking: ONC Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) Final Rule; CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) (recommended)

HL7® FHIR® Da Vinci Documentation Templates and Rules Implementation Guide (DTR IG)

This implementation specification provides a framework for payers to define documentation requirements and provider-specific rules, while enabling providers to automatically submit the necessary documentation via FHIR APIs. This specification is essential for standardizing API-based electronic prior authorization workflows, which aim to reduce delays in patient treatment and alleviate the administrative burden on providers.
Developed by the HL7 Da Vinci Project, the DTR IG is available for implementation without licensing requirements, making it accessible to payers and providers.
Payers and providers should consider the DTR IG to streamline the prior authorization process. By automating the submission of required documentation, this specification reduces the administrative workload associated with prior authorization.
Referenced in Federal Rulemaking: ONC Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) Final Rule; CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) (recommended)

HL7® FHIR® Da Vinci Prior Authorization Support Implementation Guide (PAS IG)

This implementation specification defines a framework for payer and provider health IT systems to support the submission, receipt, and response to electronic prior authorization requests. This specification is critical for standardizing API-based electronic prior authorization workflows, helping to reduce patient treatment delays and alleviate the administrative burden on providers. Together with the Coverage Requirements Discovery (CRD) IG and Documentation Templates and Rules (DTR) IG, the PAS IG forms a comprehensive solution for streamlining prior authorization processes.
Developed by the Da Vinci Project Accelerator, the PAS IG is available for implementation without licensing requirements, making it accessible to payers and providers.
Referenced in Federal Rulemaking: ONC Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) Final Rule; CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) (recommended)

HL7® FHIR® Da Vinci Da Vinci Clinical Data Exchange Implementation Guide (CDex IG)

This Implementation specification provides a framework for data exchange between providers and payers, as well as provider-to-provider and payer-to-payer workflows, for patient EHR data. The CDex IG supports query-based, task-based, and documents-based data exchange workflows.
The CDex IG is not intended to replace other HL7 FHIR Da Vinci specifications required by the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F). Instead, it focuses on specific workflows at the provider-payer interface, particularly when there is a need for manual review of received data query requests from external providers or payers. It is important to note that the CDex IG should not be implemented for workflows requiring real-time responses. Instead, it is suitable for scenarios where manual review of data query responses is necessary before delivering the data to partner providers or payers.
Certified Health IT developers, providers, and payers are encouraged to consider the CDex IG as a starting point for supporting data exchange at the provider-payer interface. This specification enables controlled and structured data sharing while allowing manual oversight to ensure accuracy and compliance in data exchange workflows.

Limitations, Dependencies, and Preconditions for Consideration	Applicable Security Patterns for Consideration
The Health Insurance Portability and Accountability Act (HIPAA) provides the regulatory foundation for electronic health care transactions. More information is available on the CMS website. ASETT serves as the HHS compliance tool for testing and complaint filing related to X12 and NCPDP® transactions. A coordinated regulatory effort now mandates the use of specific HL7 FHIR Implementation Guides (IGs) for prior authorization: Coverage Requirements Discovery (CRD), Documentation Templates and Rules (DTR), and Prior Authorization Support (PAS). The CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) requires payers (e.g., Medicare Advantage plans) to build their APIs using these standards. Complementing this, the Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule requires EHR vendors to adopt these same standards to achieve product certification. The HL7 Dental Data Exchange STU IG provides FHIR and CDA-based templates for Dental Referral and Consultation Notes, enabling standardized exchange between medical and dental providers.	All covered entities and their business associates are required to comply with the HIPAA Privacy and Security Rules. Health and Human Services has partnered with the Office of the National Coordinator and the National Institutes of Standards and Technology to publish comprehensive guidance for Security specific to electronic protected health information. A self-assessment tool kit is available to support integrating privacy and security into practices.

Limitations, Dependencies, and Preconditions for Consideration

Applicable Security Patterns for Consideration

The Health Insurance Portability and Accountability Act (HIPAA) provides the regulatory foundation for electronic health care transactions. More information is available on the CMS website.
ASETT serves as the HHS compliance tool for testing and complaint filing related to X12 and NCPDP® transactions.
A coordinated regulatory effort now mandates the use of specific HL7 FHIR Implementation Guides (IGs) for prior authorization: Coverage Requirements Discovery (CRD), Documentation Templates and Rules (DTR), and Prior Authorization Support (PAS).
- The CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) requires payers (e.g., Medicare Advantage plans) to build their APIs using these standards.
- Complementing this, the Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule requires EHR vendors to adopt these same standards to achieve product certification.
The HL7 Dental Data Exchange STU IG provides FHIR and CDA-based templates for Dental Referral and Consultation Notes, enabling standardized exchange between medical and dental providers.

All covered entities and their business associates are required to comply with the HIPAA Privacy and Security Rules. Health and Human Services has partnered with the Office of the National Coordinator and the National Institutes of Standards and Technology to publish comprehensive guidance for Security specific to electronic protected health information. A self-assessment tool kit is available to support integrating privacy and security into practices.

Form Guide

1. Optional: Background Text / Cover Letter

The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.

This field is entirely optional and serves the following purposes:

Provides context for reviewers
Serves as an introduction if submitting multiple comments
Functions as a cover letter for formal submissions

If you are submitting a single comment for a specific data class or element, you may leave this field blank. For multiple comments, this space is useful for explaining the overall purpose or connection between your comments.

Fig 1 The "Optional Background Text / Cover Letter" field allows users to provide contextual information or introductory remarks for their comment submission.

2. Complete the Comment Form

The comment form contains several fields that require your input:

ISA Content: This field is automatically populated based on the page you are currently viewing. No action is required.

Standards and Implementation Specifications: This drop-down menu is pre-selected based on the topic you're commenting on. The selection reflects the relevant standard or implementation specification for your current page.

Subject: Enter a concise title that summarizes the focus of your comment. This helps reviewers quickly understand the nature of your feedback.

Comment: This is the main field where you provide your detailed feedback, concerns, or suggestions. The comment box includes a text editor with formatting options that allow you to:

Format text as bold or italic
Insert hyperlinks
Create bullet points
Create numbered lists
Apply strike-through formatting
Attach images
Insert tables

Use these formatting options as needed to clearly present your information.

Fig 2 The comment text editor toolbar provides formatting options including bold, italic, links, lists, tables, and image insertion capabilities.

3. Optional: Add Additional Comments

If you need to provide feedback on multiple aspects of the ISA content, you can add additional comments:

After completing your first comment, locate and click the link labeled "Comment on another interoperability need" at the bottom of the form.
A new comment section will appear, allowing you to enter details for your additional comment.
For this new comment section, the "ISA Content" and "Standards and Implementation Specifications" fields will not be automatically populated. You must select the appropriate content and specification from the drop-down menus for each additional comment.
Complete all required fields for your additional comment.
Repeat this process for each additional comment you wish to submit.

Fig 3 The "Comment on another interoperability need" link enables users to add multiple comments within a single submission.

4. Optional: Upload Supporting Files

The platform allows you to upload supporting documentation to enhance your comment:

Locate the "File Upload" section at the bottom of the comment form.
Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.

Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.

Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

5. Optional: Save and Exit

If you need to pause your work and return to complete your comment later:

Click the "Save and Exit" button at the bottom of the form.
Your comment will be saved as a draft that you can access and complete later.
When you return to the platform, you will see a red triangle with an exclamation mark next to the "Return to saved Comment" button, indicating that you have saved comments in draft status.
Click the "Return to saved Comment " button to continue working on your draft.
You will be taken to a review page where you can:
1. Select "Submit Comment" to officially submit your feedback.
2. Click "Edit" to return to the comment form and make changes
3. Select "Discard Draft" to delete the saved draft and start fresh

Fig 5 A red triangle with exclamation mark indicator appears next to the "Return to saved Comment" button when draft comments are saved in the system.

6. Review and Submit

Once you have completed your comment:

Click the "Review and Submit" button at the bottom of the form.
This will take you to a review screen displaying your comment(s) in full.
Review all information for accuracy and completeness.
On this review screen, you have three options:
1. Click "Submit Comment" to officially submit your feedback
2. Click "Edit" to return to the comment form and make changes
3. Click "Discard Draft" to delete the comment and start fresh
The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records.
If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.

Fig 6 The review screen includes a "Print" button that allows users to create a record of their comment submission.

Referral Certification and Authorization Request and Response for Dental, Professional and Institutional Services

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Referral Certification and Authorization Request and Response for Dental, Professional and Institutional Services

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1. Optional: Background Text / Cover Letter

2. Complete the Comment Form

3. Optional: Add Additional Comments

4. Optional: Upload Supporting Files

5. Optional: Save and Exit

6. Review and Submit

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