Health Care Claims or Equivalent Encounter Information for Dental Claims

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Implementation Specification	ASC X12®N/005010X224 ASC X12 Standards for Electronic Data Interchange Technical Report Type 3—Health Care Claim: Dental (837), May 2006 as an ASC X12 Standards for Electronic Data Interchange Technical Report Type 3 and	Final	Production		Yes	$	Yes
Implementation Specification	HL7® FHIR® Consumer Directed Payer Data Exchange Implementation Guide (CARIN IG for Blue Button®)	Balloted Draft	Pilot		Yes	Free	Yes Yes

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® Consumer Directed Payer Data Exchange Implementation Guide (CARIN IG for Blue Button®) This implementation specification provides a framework for payers to enable patient access to their claims information via a standardized FHIR API. It defines the Common Payer Consumer Data Set (CPCDS), which is a set of FHIR resources that payers can make available to patients. In addition to patient access, the profiles in this IG are expected to be reusable for other use cases, such as Provider Access and Payer-to-Payer APIs. CMS has identified CARIN IG for Blue Button Version 2.0.0 as ready for adoption in Certified Health IT. Developed by the CARIN Alliance, the IG is available for implementation without licensing requirements, making it accessible to payers and health IT developers. Implementers are encouraged to adopt the CARIN IG for Blue Button for use cases that require payers to provide patients with access to their claims information. Referenced in Federal Rulemaking: CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)

Federal FHIR Action Plan Alignment

HL7® FHIR® Consumer Directed Payer Data Exchange Implementation Guide (CARIN IG for Blue Button®)

This implementation specification provides a framework for payers to enable patient access to their claims information via a standardized FHIR API. It defines the Common Payer Consumer Data Set (CPCDS), which is a set of FHIR resources that payers can make available to patients. In addition to patient access, the profiles in this IG are expected to be reusable for other use cases, such as Provider Access and Payer-to-Payer APIs.
CMS has identified CARIN IG for Blue Button Version 2.0.0 as ready for adoption in Certified Health IT. Developed by the CARIN Alliance, the IG is available for implementation without licensing requirements, making it accessible to payers and health IT developers.
Implementers are encouraged to adopt the CARIN IG for Blue Button for use cases that require payers to provide patients with access to their claims information.
Referenced in Federal Rulemaking: CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)

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. HIPAA has some different requirements for information exchange than EHRs, but there is hope for convergence in the future. Information about the HIPAA regulations regarding standards and operating rules can be found at https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/HIPAA-ACA/index.html. Readers can find information about requirements for covered entities and their business associates and enforcement from this link. This standard and the transaction were adopted under the Health Insurance Portability Act of 1996 (HIPAA) to increase efficiency in the health care system by reducing the use of paper and increasing the exchange of health care information electronically. This information is often maintained in provider practice management and billing systems but duplicates information in electronic health records. This transaction is also used to conduct coordination of benefits (COB) between organizations that agree to do so. 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. Additional information is available on testing, and the full cost on any of the X12 transactions. ASETT is the HHS compliance tool to enable testing and complaint filing for all 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. The May 2020 CMS Patient Access and Interoperability Rule enables patients in Medicaid, Medicaid Managed Care, Medicare Advantage and Qualified Health Plans on the Federally Facilitated Exchanges to request that their payer allow them to have their data sent to a health app of their choice upon request through an API. CMS has recommended the use of certain HL7 based Implementation Guides. The HL7 FHIR Consumer Directed Payer Data Exchange (CARIN IG for BlueButton®) STU 2 is one of those IGs, and enables the exchange of dental claims.	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. HIPAA has some different requirements for information exchange than EHRs, but there is hope for convergence in the future. Information about the HIPAA regulations regarding standards and operating rules can be found at https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/HIPAA-ACA/index.html. Readers can find information about requirements for covered entities and their business associates and enforcement from this link.
This standard and the transaction were adopted under the Health Insurance Portability Act of 1996 (HIPAA) to increase efficiency in the health care system by reducing the use of paper and increasing the exchange of health care information electronically. This information is often maintained in provider practice management and billing systems but duplicates information in electronic health records.
This transaction is also used to conduct coordination of benefits (COB) between organizations that agree to do so.
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.
Additional information is available on testing, and the full cost on any of the X12 transactions. ASETT is the HHS compliance tool to enable testing and complaint filing for all 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.
The May 2020 CMS Patient Access and Interoperability Rule enables patients in Medicaid, Medicaid Managed Care, Medicare Advantage and Qualified Health Plans on the Federally Facilitated Exchanges to request that their payer allow them to have their data sent to a health app of their choice upon request through an API. CMS has recommended the use of certain HL7 based Implementation Guides. The HL7 FHIR Consumer Directed Payer Data Exchange (CARIN IG for BlueButton®) STU 2 is one of those IGs, and enables the exchange of dental claims.

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.

Add a New Comment

Review comment and Submit

Edit

Optional Background Text / Cover Letter

Comment #1

ISA Content

Subject

Comment

Submitted by markaroberts85 on 2022-10-01

CARIN Alliance Comments on ISA

The CARIN Alliance, a multi-sector group of stakeholders requests that ONC update the Health Care Claims or Equivalent Encounter Information for Professional Claims and Institutional Claims in the ISA to include the latest information related to the HL7® FHIR® Consumer Directed Payer Data Exchange (CARIN IG for Blue Button®) Implementation Guide (IG). Please see the attached comment letter for additional details.

CARIN Alliance Comments on ISA 093022_0.pdf