On September 15th, 2021, CMS released three FAQ documents that announced “enforcement discretion” around the payer-to-payer exchange, one element of the interoperability rule for payers and providers. What does this mean for payers working to comply with this requirement and what does it mean for all the other related areas of interoperability?
The Payer-to-Payer exchange was one part of the final rule related to CMS/ONC interoperability from the 21st Century Cures Act. It required many payers to allow a current or former member to direct the transmission of their clinical data to another payer. As readers of MedCity News learned from the August 2021 article “What payers need to know about CMS’ Payer-to-Payer Data Exchange requirement”, this portion of the rule was badly worded and difficult to implement. This mandate was to take effect January 1, 2022 and payers have been working for months to meet that deadline, despite the deficiencies of that part of the rule. In their announcement removing that deadline, CMS indicated that the delay would reduce tension regarding implementation and prevent discordant data from flowing.
Even staunch advocates of the interoperability efforts in the 21st Century Cures Act would agree that this delay was the correct step for CMS. Simply put, the capabilities the payers were building with the limited information available in the rule would have resulted in a lot of bad data and frustration at a time when such data sharing should be on its ascendency. It is better to pause and write better rules for this one section that will make this form of data sharing effective and coherent with the other areas of interoperability.
What Does “Enforcement Discretion” Mean?
CMS now says that it will not enforce compliance until additional rulemaking occurs. It is important to note that enforcement discretion is not the same as rescinding or canceling a regulation. CMS could have done so, but instead chose to keep the regulation. That signals their intent to “fix” the final rule details and publish them in a future mandate.
This is not the first time CMS has used the enforcement discretion approach. Indeed, the payer version of the Patient Access API is another part of the CMS/ONC interoperability final rule. The original deadline for that part of the rule was January 1, 2021, but last year CMS similarly announced enforcement discretion for this part of the rule until July 1, 2021.
In their September 2021 announcement, CMS encouraged payers who have the ability to implement the Payer to Payer exchange through API to do so. This signals their likely intent in future rulemaking to better feature the “reuse” of the payer version of the Patient Access API to meet this need.
In sum, Enforcement Discretion means that plans should stop working on any implementation that was designed to meet this mandate and either wait for new rules or refocus their efforts toward building (non-mandated) integrations of value to other payers that leverage FHIR and the Patient Access API.
What New Requirements Will CMS Publish?
An educated guess suggests that CMS will require plans to support the use of the Patient Access API to allow members to move their data from one plan to another. To do so, there are a number of topics CMS needs to address. First, it would make sense to change the mandate’s focus from the Sending Payer to the Receiving Payer, as that would allow a traditional use of the RESTful API. So, a new rule should mandate that the member asks the Payer where they want to receive the data to make the request (on their behalf) to their earlier Payer. There are specific details on how consent should be tokenized in this arrangement that would maximize the reuse of what Payers have already built. Finally, CMS might choose to expand the scope from the current limitation of USCDI data to all the data in the Patient Access API, which would significantly add claims information.
For more insight, the suggestion in the September 15th announcement indicates their plan to make the new version of this rule more sophisticated and fully FHIR and API based. Payers wanting to dive deeper could look at the December 2020 proposed rule CMS-9123-P, but it should be remembered that this was published by the Trump administration in a rush and the new administration may want to take the time to consider the approach more carefully. Significantly, the 2020 proposed rule indicated the use of FLAT FHIR and that is not in scope of the currently mandated Patient Access API (but is a likely target for future mandates).
The timing of the future mandate is the biggest concern of payers. There is nothing in the CMS communication that sets forth the timeline of the new rules and their associated deadlines. It could be weeks or years. It can be anticipated that these rule updates may be part of a broader communication of additional interoperability requirements beyond those in the May 2020 final rule. Payers should anticipate that additional rules and mandates regarding interoperability are likely.
Does This Delay Signal a Change in Priority from CMS?
The new administration is likely to focus on its own policy priorities, such as Social Determinants of Health, health equity, and public health. But it would be a mistake to assume that it will not continue to push the interoperability adoption, for many reasons.
First, recall that the enabling legislation was overwhelmingly supported by both Republicans and Democrats during the Obama administration and major rulemaking occurred by the Trump administration. The Act itself, which also addressed cancer research and other areas, was a priority for Vice-President Biden when it was passed.
Second, interoperability is an infrastructural capability that is a prerequisite for other healthcare topics. Everything from measuring success in Health Equity to preparing for the next pandemic will greatly benefit from a robust interoperability capability.
Perhaps most importantly, a basic goal of the interoperability rule is as important as ever: reducing medical spend. The US government is the biggest purchaser of healthcare in the world. It rightly believes that interoperability will lead to a reduction in medical spend as patient, providers, and all types of businesses have secure access to standardized healthcare data. This administration is no less focused on steps that will reduce healthcare costs.
For these and other reasons, this delay on the Payer-to-Payer exchange should not be seen as a signal that the new administration will relent on the implementation of interoperability. The next major milestones will be enforcement of the Payer version of the Patient Access API, release of additional regulations and mandates that further advance interoperability, and the January 2023 deadline for providers with certified EMRs to support the provider version of the Patient Access API. The current delay is specific to one part of the law that needed rework; it should not be seen as an indicator that interoperability will not happen. Payers should continue to invest in interoperability as both a compliance mandate and a strategic business opportunity.