ONC & CMS Interoperability Regulations: Part 1 – Payer Impact


John D’Amore, MS, President and Chief Strategy Officer

This is Part One of a four-part series that will cover major implications of the March 2020 ONC and CMS regulations for interoperability. Each segment of the series highlights the impact of the regulations on one stakeholder group in the healthcare ecosystem: Health Insurers, Health Information Technology, HIEs/Patients and Providers.  While we can’t comprehensively cover all parts of the regulations, in this series we will talk through nuances of clinical data exchange in depth.

Part One focuses on what the regulations mean for health insurers who offer Medicare Advantage and Managed Medicaid plans. Health plans in this category have the most urgent deadlines, so it’s time to tune in!

First things first, you can access the entire regulations as well as other resources here:

Needless to say, you might not want to trudge through 1,700 pages of detailed regulations. Diameter Health has highlighted the most meaningful changes below:

Health Insurers: There’s No Time to Waste!

The most pressing things for health plans to be aware of are the near-term deadlines. Some expected these deadlines to be a few years out, but the final rule had a big surprise. Payer compliance begins January 1, 2021. In the words of Lenel James, Business Executive from Blue Cross Blue Shield Association “nine months away…. It’s like tomorrow!”

Here are the details:

FHIR R4 or Bust!

The first requirement is going to be the hardest for most payers. While most maintain online portals for members, the requirement to provide APIs so that members can access data through apps on their phone will be challenging. Per the regulation, payers won’t be able to create a walled garden where only some apps can be used.

The regulatory text is relatively unambiguous regarding what needs to be provided to members:

“The Patient Access API must include all of the specified clinical information for the enrollee maintained by the payer with a date of service on or after January 1, 2016.” (CMS Page 105)

These APIs will use a new standard for data access called Fast Healthcare Interoperability Resources (FHIR, pronounced like “fire”). The version of FHIR that will be required is called R4. Some parts of FHIR R4 became normative standards in early 2019, meaning that they are ready for widespread use. Other parts, however, are less mature but payers will still need to use them.

It’s Not Just Claims and Encounters, Dorothy

Using the FHIR standard, health plans will need to make specific types of information available, namely:

  • adjudicated claims
  • encounters with capitated providers
  • provider remittances
  • enrollee cost-sharing
  • clinical data (including laboratory results)

The expectation in the regulations is that information is available the next business day after being processed by a health plan. Mechanisms for authentication and access will follow industry standards such as OAuth2 and OpenID Connect Core. Health plans have robust systems to process the first four types of data, which can be mapped to three parts of FHIR, specifically: (1) Explanation of Benefits; (2) Patient; and (3) Coverage resources. Some health plans have already begun substantial work in making this data available. If your organization hasn’t started, now is the time.

The final category information — clinical data — will be the most valuable data for patients but presents the highest hurdle for plans. Clinical data arrives in many different forms (including HL7v2, C-CDA documents, supplemental files) and will need to be mapped to a large directory of FHIR resources. Specifically, the regulations call out the usage of the US Core Data for Interoperability (USCDI), which uses over a dozen different parts of the FHIR standard.

Don’t Panic. Help Is Here

This regulatory mandate will require that your organization tap into expertise and the right tools for success – now. Diameter Health will be sharing our know-how with you through this series. But it’s not just about know-how. Our software engineers and clinical informaticists have been relentlessly focused on unlocking the value of clinical data via interoperability standards and have already demonstrated support for FHIR.

Diameter Health has worked with many regional and national health plans over the past several years that have acquired large quantities of clinical data to improve quality scores (i.e. HEDIS), risk adjustment, care management and population health. By incorporating our data normalization and enhancement technology into their clinical data acquisition strategy, these health plans have ensured that these data are interoperable with downstream systems for these business processes.

In March 2020, we presented a clinical data interchange scenario with health plans about how to make this data accessible on FHIR (Da Vinci webinar).

That said, now is the time to get the conversation rolling given the importance of this rule. For more information, please reach out to Diameter Health (use the “Sign Up” form at the top right of this page and we’ll alert you to future posts) or listen to our virtual HIMSS 2020 sessions here:

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