CMS Interoperability - Implementation Guides and Standards

Implementation Guides and Standards

The Health Informatics and Interoperability Group (HIIG) works with standards development organizations, federal partners, and industry stakeholders to develop technical standards and Implementation Guides (IGs). These standards and IGs help to ensure that health information can be exchanged electronically in a consistent and reliable manner. The HIIG also promotes the adoption of Health Level Seven? (HL7?) Fast Healthcare Interoperability Resources? (FHIR?) by stakeholders. FHIR? is a standard for exchanging health information that is designed to be easy to use and implement.

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Technical Standards: Technical standards play a pivotal role in ensuring the secure and efficient flow of clinical and administrative data between software applications utilized by healthcare providers, payers, and health information technology (IT) developers. These standards define data format, structure, and common terminology, facilitating the exchange of information and medical concepts across different systems. This ultimately leads to improved care coordination among payers and various types of providers, resulting in enhanced patient outcomes. The Centers for Medicare & Medicaid Services (CMS) interoperability policies necessitate the use of specific technical standards.

1.????? HL7 FHIR

Fast Healthcare Interoperability Resources? (FHIR?), maintained by Health Level 7? (HL7?), is a standardized approach for exchanging healthcare information among different computer systems, irrespective of their internal data storage methods. FHIR? enables rapid and efficient sharing of health data, encompassing clinical and administrative information.

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2.????? HL7 SMART APP Launch Framework

SMART on FHIR introduces a reliable and secure authorization mechanism for various app architectures, based on the OAuth 2.0 standard. Designed for app developers seeking access to FHIR? resources, it involves requesting access tokens from OAuth 2.0 compliant authorization servers. The profile outlines an approach for requesting authorization to access FHIR? resources and utilizing that authorization to retrieve the desired resource.

3.????? Open ID Connect Core

OpenID Connect 1.0 serves as a straightforward identity layer built atop the OAuth 2.0 protocol. It empowers clients to verify the end-user's identity through an authorization server's authentication process. Additionally, it enables the acquisition of basic profile information about the end-user in an interoperable and RESTful manner. This specification defines core functionalities of OpenID Connect, encompassing authentication atop OAuth 2.0 and the utilization of claims to convey end-user information. It also outlines security and privacy considerations associated with OpenID Connect usage.

?4.????? United States Core Data for Interoperability (USCDI)

USCDI establishes a standardized collection of health data classes and component data elements. Designed for nationwide, interoperable health information exchange, USCDI forms a foundational framework supporting the broader sharing of electronic health information, aimed at enhancing patient care coordination.

Implementation Guides (IGs): Implementation Guides provide comprehensive guidance for meeting both finalized and proposed regulatory requirements for Application Programming Interfaces (APIs), eliminating the need for developing independent approaches. The recommended IGs listed below have been collaboratively developed through industry-led consensus, following a transparent public process, and are made available for free. Furthermore, these IGs offer practical reference implementations tailored to specific use cases, complete with test data. This feature allows entities to observe the APIs in operational scenarios, aiding testing and development efforts. Links to the relevant HL7? work groups responsible for advancing these IGs are provided beneath each respective use case.

?1.????? CARIN Consumer Directed Payer Data Exchange IG (CARIN IG for Blue Button?):

The CARIN for Blue Button IG employs Explanation of Benefits (EOB) data to empower beneficiaries to access their claims and encounter data. This electronic information can be shared via an API.

?Use Cases: The Medicare Blue Button facilitates beneficiaries' access to Medicare Parts A, B, and D claims and encounter data. This data can be shared electronically through an API, benefiting approved applications, services, and selected research programs.

?2.????? HL7 US Core Implementation IG:

This IG sets a foundational standard to boost interoperability and adoption through unified implementation. It outlines the minimal constraints applicable to FHIR? resources, establishing the US Core Profiles. Furthermore, it defines the least set of FHIR? RESTful interactions for each US Core Profile to access patient data.

Use Cases: The US Core FHIR? profiles serve as essential prerequisites for FHIR? implementation within the US Realm. All US Realm implementation guides are expected to utilize these US Core profiles unless specific justifications for non-adoption are explicitly stated.

3.????? HL7 FHIR Da Vinci Payer Data Exchange (PDex) IG:

The HL7 FHIR Da Vinci PDex IG facilitates the seamless exchange of clinical information between health plans, members, and providers, particularly when transitioning between payers.

Use Cases: The IG's objective is to enable payers to construct a comprehensive health history for members using clinical resources and data, understandable to providers, and seamlessly integrated into their electronic health record (EHR) systems. The clinical data provided via PDex should not be derived from claims data.

4.????? HL7 FHIR Da Vinci PDex U.S. Drug Formulary IG:

This IG establishes a FHIR? interface to deliver payer-specific drug formulary information to patients and consumers during the enrollment process.

Use Cases: This IG empowers patients to comprehend drug costs and alternatives for prescribed medications, fostering informed decision-making. Additionally, patients can compare drug costs across diverse insurance plans.

5.????? HL7 FHIR Da Vinci PDex Plan Net IG:

The HL7 FHIR Da Vinci PDex Plan Net IG outlines the requisite profiles and criteria to enable health plans to publish healthcare and pharmacy network information, accessible via an API.

Use Cases: This IG intends to create an API that provides access to a payer's provider network and pharmacies, catering to consumer or provider applications. However, it is important to note that the resulting API only supports querying capabilities and does not permit modifications to the directory.

6.????? HL7 FHIR Da Vinci Prior Authorization Support (PAS) IG:

The HL7 FHIR Da Vinci Prior Authorization Support (PAS) IG facilitates direct transmission of prior authorization requests, including immediate authorization, through mapping between FHIR? and X12 transactions. This is designed for integration with EHR systems using the FHIR? standard.

Use Cases: This IG addresses the challenge of manual prior authorization requests by offering an automated solution for providers and clinical support staff. It streamlines the process of submitting prior authorizations, which are often communicated manually through methods like fax or payer-specific portals.

7.????? HL7 FHIR Da Vinci Coverage Requirements Discovery (CRD) IG:

The HL7 FHIR Da Vinci Coverage Requirements Discovery (CRD) IG establishes a workflow for payers to convey coverage requirements to providers via clinical systems at the time of treatment decisions.

Use Cases: This IG supports APIs that enable payers to query provider systems for additional patient information needed to inform treatment decisions. By determining existing information and previous steps, this functionality enhances the guidance provided by payers with authorization requirements.

8.????? HL7 FHIR Da Vinci Documentation Templates and Rules (DTR) IG:

The HL7 FHIR Da Vinci Documentation Templates and Rules (DTR) IG outlines the execution of payer rules within a provider context to ensure compliance with documentation requirements. It works in conjunction with the Coverage Requirements Discovery (CRD) IG.

Use Cases: This IG serves to collect clinical documentation and encourage the completion of necessary documentation to demonstrate medical necessity for ordered items or services.

9.????? HL7 FHIR Bulk Data Access (Flat FHIR) Specification:

The HL7 FHIR Bulk Data Access (Flat FHIR) Specification defines a standardized approach for exporting bulk data from a FHIR? server to an authorized client. The process involves extracting a specific subset of fields, mapping them into a structured format (e.g., CSV), and storing them on a server. Requesters can then download these files into the intended target system.

Use Cases: This implementation guide facilitates sharing data, represented in FHIR?, across various systems, including native FHIR? servers, EHR systems, population health tools, and financial systems.

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References:

[1] Centers for Medicare & Medicaid Services. (2023, March 8). About CMS: OBRHI: Interoperability. Retrieved from https://www.cms.gov/about-cms/obrhi/interoperability

[2] Centers for Medicare & Medicaid Services. (2023, March 8). Regulations & Guidance: Administrative Simplification. Retrieved from https://www.cms.gov/regulations-guidance/administrative-simplification

[3] Centers for Medicare & Medicaid Services. (2023, March 8). Newsroom: Fact Sheets: Advancing Interoperability and Improving Prior Authorization Processes: Proposed Rule CMS-0057-P Fact Sheet. Retrieved from https://www.cms.gov/newsroom/fact-sheets/advancing-interoperability-and-improving-prior-authorization-processes-proposed-rule-cms-0057-p-fact

[4] U.S. Department of Health and Human Services. (2022, March 8). Final Rule: Promoting Interoperability, Transparency, and Accountability in Health Information Technology. Retrieved from https://www.federalregister.gov/d/2022-26479

[5] U.S. Department of Health and Human Services. (2020, July 15). Cures Act Final Rule: Interoperability, Patient Access, and Certain Other Modernization Provisions of the Patient Protection and Affordable Care Act. Retrieved from https://www.healthit.gov/topic/oncs-cures-act-final-rule

[6] U.S. Department of Health and Human Services. (2020, July 15). Final Rule: Promoting Interoperability and Patient Access to Electronic Health Information through the ONC Health IT Certification Program. Retrieved from https://www.federalregister.gov/d/2020-07419

[7] Centers for Medicare & Medicaid Services. (2023, March 8). Implementation Guides and Standards: Application Programming Interfaces (APIs) and Relevant Standards and Implementation Guides (IGs). Retrieved from https://www.cms.gov/about-cms/obrhi/interoperability/implementation-guides-and-standards/application-programming-interfaces-apis-and-relevant-standards-and-implementation-guides-igs#

[8] Centers for Medicare & Medicaid Services. (2023, March 8). Implementation Guides and Standards: Standards and IGs Index and Resources. Retrieved from https://www.cms.gov/about-cms/obrhi/interoperability/implementation-guides-and-standards/standards-and-igs-index-and-resources

[9] U.S. Department of Health and Human Services. (2023, March 8). United States Core Data for Interoperability (USCDI): USCDI v1. Retrieved from https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi#uscdi-v1

[10] S. Sahu, "CMS Interoperability: The Future of Connected Care," LinkedIn, [Online]. https://www.dhirubhai.net/pulse/cms-interoperability-future-connected-care-shreekanta-sahu/?trackingId=SrXhXN%2F1REqd9g%2B2IDdRLQ%3D%3D

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