CMS Interoperability and Patient Access Final Rule (CMS-9115-F)

CMS Interoperability and Patient Access Final Rule (CMS-9115-F)
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CMS Interoperability and Patient Access Final Rule (CMS-9115-F)

The Centers for Medicare & Medicaid Services (CMS) published the Interoperability and Patient Access Final Rule on May 1, 2020, putting patients first, giving them access to their health information when they need it most and in a way, they can best use it. This final rule focused on driving interoperability and patient access to health information by liberating patient data using CMS authority to regulate Medicare Advantage (MA), Medicaid, Children's Health Insurance Program (CHIP), and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs).

This regulation includes policies which require or encourage payers to implement Application Programming Interfaces (APIs) to improve the electronic exchange of healthcare data—sharing information with patients or exchanging information between a payer and provider or between two payers. Through this rule, CMS adopted the content and vocabulary standards that were finalized by the Department of Health and Human Services (HHS) in the ONC 21st Century Cures Act final rule, to support these API policies. APIs can connect to mobile apps or to a provider electronic health record (EHR) or practice management system to enable a more seamless method of exchanging information.

You can find links to resources that are useful for implementing the APIs to support the policies of these rules in the Implementation Guides and Standards section of this website. We encourage stakeholders to use the general information for the Health Level 7® (HL7®) Fast Healthcare Interoperability Resources® (FHIR®) Implementation Guides (IGs) referenced in the CMS regulations.


Read the Fact Sheet to learn more about this final rule


View the CMS Interoperability and Patient Access Final Rule in the Federal Register


On December 8, 2021 
CMS announced the publication of a Federal Register Notice (FRN CMS-9115-N2) to formalize its decision to exercise enforcement discretion not to take action against certain payer-to-payer data exchange provisions of the May 2020 Interoperability and Patient Access Final Rule (see FAQs associated with this decision). The Administrator also released a blog on this Notice, which included additional information about the administration's commitment to increasing health data exchange and investing in interoperability.


Guidance for States 
In August 2020, CMS released a letter to state health officers detailing how state Medicaid agencies should implement the CMS Interoperability and Patient Access Final Rule (CMS-9115-F) in a manner consistent with existing guidance. There are many provisions in this regulation that impact Medicaid and CHIP Fee-For-Service (FFS) programs, Medicaid managed care plans, and CHIP managed care entities, and this letter discusses those issues. Additionally, this letter advises states that they should be aware of the ONC’s 21st Century Cures Act Final Rule on information blocking.


Read the letter

Best Practices for Payers and App Developers 
This document includes links to useful information and best practices to help payers and developers build and maintain a FHIR-based API, as well as best practices for third-party app developers.

Privacy and Security Resources 
This document provides an overview of what is required to be included in a payer’s patient resource document and some content payers may choose to use to help meet this requirement. Use of this document is not required; it is to support payers as they produce patient resources tailored to their patient population.

Page Last Modified:
07/01/2024 11:31 AM