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 Implementation Guide (CRD IG)	Balloted Draft	Production	Yes	Free	Yes Yes
Implementation Specification	HL7® FHIR® Da Vinci Documentation Templates and Rules Implementation Guide (DTR IG)	Balloted Draft	Production	Yes	Free	Yes Yes
Implementation Specification	HL7® FHIR® Da Vinci Prior Authorization Support Implementation Guide (PAS IG)	Balloted Draft	Production	Yes	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. CMS has identified CRD IG Version 2.0.1 as ready for adoption in Certified Health IT. 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: CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) 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. CMS has identified DTR IG Version 2.0.0 as ready for adoption in Certified Health IT. 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: CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) 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. CMS has identified PAS IG Version 2.0.1 as ready for adoption in Certified Health IT. 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: CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) 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.
CMS has identified CRD IG Version 2.0.1 as ready for adoption in Certified Health IT. 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: CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)

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.
CMS has identified DTR IG Version 2.0.0 as ready for adoption in Certified Health IT. 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: CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)

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.
CMS has identified PAS IG Version 2.0.1 as ready for adoption in Certified Health IT. 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: CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)

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 Administrative Simplification provisions of HIPAA apply to the adoption of electronic transaction standards and operating rules for use in the health care industry. Information about the HIPAA regulations and enforcement may be found at https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/HIPAA-ACA/index.html. Adoption of standards to increase the efficiency of the health care system was required by the Health Insurance Portability Act of 1996 (HIPAA). The most recent versions of the medical and pharmacy standards were adopted in 2009, with a January 2012 compliance date. The purpose of the electronic standard transactions is to improve efficiency in the health care system by reducing the use of paper and increasing the electronic exchange of health care information. Before implementation of a new version of a standard, end to end testing should be conducted with vendor systems and between trading partners to ensure changes have been accommodated. ASETT is the HHS compliance tool to enable testing and complaint filing for X12 and NCPDP® transactions. For a description of the functionality of each transaction, visit the X12 website. Click on a transaction set name to toggle the display of the purpose and scope of that transaction set. HL7 Da Vinci Burden Reduction HL7 FHIR IGs for Prior Authorization were recommended for Use in the February 2024 CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) Coverage Requirements Discovery (CRD). The goal of the CRD use case is to give providers real-time access to payer approval requirements, documentation, and rules at point of service to reduce provider burden and support treatment planning. Documentation Templates and Payer Rules (DTR). The goal of the DTR use case is to reduce provider burden and simplify process by establishing electronic versions of administrative and clinical requirements that can become part of the providers workflow. Prior Authorization Support (PAS). The goal of the PA use case is to define FHIR based services to enable provider, at the point of service, to request authorization (including all necessary clinical information to support the request) and receive immediate authorization. Da Vinci use cases are piloted and tested during connectathons hosted by HL7 and approved professional affiliates throughout the year. To learn more about connectathons and other Da Vinci use cases or FHIR accelerator programs, visit www.HL7.org or http://www.hl7.org/about/davinci/use-cases.cfm. The HL7 Dental Data Exchange STU Implementation Guide provides both FHIR-based and CDA-based sets of templates defining the Dental Referral Note and Dental Consultation Note. These standardized documents are intended to support bi-directional information exchange between a medical and a dental provider or between dental providers. This publication provides the data model, defined data items, and their corresponding code and value sets, specific to a dental referral note and dental consultation note intended for exchange.	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 Administrative Simplification provisions of HIPAA apply to the adoption of electronic transaction standards and operating rules for use in the health care industry. Information about the HIPAA regulations and enforcement may be found at https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/HIPAA-ACA/index.html.
Adoption of standards to increase the efficiency of the health care system was required by the Health Insurance Portability Act of 1996 (HIPAA). The most recent versions of the medical and pharmacy standards were adopted in 2009, with a January 2012 compliance date. The purpose of the electronic standard transactions is to improve efficiency in the health care system by reducing the use of paper and increasing the electronic exchange of health care information.
Before implementation of a new version of a standard, end to end testing should be conducted with vendor systems and between trading partners to ensure changes have been accommodated.
ASETT is the HHS compliance tool to enable testing and complaint filing for X12 and NCPDP® transactions.
For a description of the functionality of each transaction, visit the X12 website. Click on a transaction set name to toggle the display of the purpose and scope of that transaction set.
HL7 Da Vinci Burden Reduction HL7 FHIR IGs for Prior Authorization were recommended for Use in the February 2024 CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)
- Coverage Requirements Discovery (CRD). The goal of the CRD use case is to give providers real-time access to payer approval requirements, documentation, and rules at point of service to reduce provider burden and support treatment planning.
- Documentation Templates and Payer Rules (DTR). The goal of the DTR use case is to reduce provider burden and simplify process by establishing electronic versions of administrative and clinical requirements that can become part of the providers workflow.
- Prior Authorization Support (PAS). The goal of the PA use case is to define FHIR based services to enable provider, at the point of service, to request authorization (including all necessary clinical information to support the request) and receive immediate authorization.
- Da Vinci use cases are piloted and tested during connectathons hosted by HL7 and approved professional affiliates throughout the year. To learn more about connectathons and other Da Vinci use cases or FHIR accelerator programs, visit www.HL7.org or http://www.hl7.org/about/davinci/use-cases.cfm.
The HL7 Dental Data Exchange STU Implementation Guide provides both FHIR-based and CDA-based sets of templates defining the Dental Referral Note and Dental Consultation Note. These standardized documents are intended to support bi-directional information exchange between a medical and a dental provider or between dental providers. This publication provides the data model, defined data items, and their corresponding code and value sets, specific to a dental referral note and dental consultation note intended for exchange.

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

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

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Format text as bold or italic
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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.
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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

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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

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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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