FHIR implementation is more than a regulatory tick off item!

The lack of interoperability has created an opaque healthcare system and contributed to suboptimal and/or high cost of care in the US. The Affordable Care Act (ACA) changed the game by ushering in value-based care and transformed the healthcare industry incentive system by shifting from episodic treatment to prevention. Technology plays an important role in steering patient behavior towards wellness and anticipating a disease or flagging its progression rather than simply treating it.

On May 1, 2020, the Centers for Medicaid and Medicare (CMS) FHIR Interoperability Mandate was implemented to achieve this. CMS describes the scope of the mandate as: “The Interoperability and Patient Access final rule (CMS-9115-F) delivers on the Administration’s promise to put patients first, giving them access to their health information when they need it most and in a way they can best use it.”

Like most initiatives with the potential to redefine industry fundamentals, FHIR has its challenges and regulatory ambiguities. When I spoke at the AHIP conference, an interesting thing that stood out was the number of lingering questions and confusion around the Rules and CMS expectations. My subsequent interactions with other health plans have also reinforced the same point.

Rumblings around extension of enforcement deadlines. COVID has put a hamstring on the industry and will continue its chokehold well into 2021. While the CMS is considering an extension of the deadline, most payers that we are speaking to are sticking to the original CMS deadline.

Payer responsibility around informing members about potential security issues related to third-party apps is a grey area.  While the objective of FHIR is to provide clinical/formulary/claims data to patients through a third-party app of their choice, In such cases, what is the responsibility of the payers to “educate” their members?  Does this mean that the payers need to maintain a list of “acceptable apps” updated periodically as well as form guidelines on what constitutes “acceptable applications”? This also means that the payer will have to deal with apps that do not meet the payer’s acceptability criteria in which case, the payer will have to “educate” the member about the third-party apps not meeting the payer’s standards. Most payers address this via disclaimer at the point of consent.

Handling the member service support is going to be messy. Will the member accessing the data via the third-party contact the app provider or the health plan, or both?  What happens if the member has a question about data that is aggregated and/or presented by the app, but is not visible to the plan’s call center? The mandate will allow the member to see their data in a more comprehensive fashion, but if the same data is not visible to the plan’s call center rep, who will be responsible for the damage to the member’s experience as a result?  Where does the plan’s responsibility end: at the point where it shares the data to the third-party app provider? Or, does it go beyond to handling customer service and member experience issues? While the mandate does not directly address the question above and may not directly impact the payer’s compliance status, payers are well advised to think of the nuances of member experience and service after FHIR implementation. Call center employees should receive additional training covering these nuances.

The real prize of interoperability is not transparency of patient data.  The health plans will do well to recognize that the scope of FHIR is more consequential than merely providing members’ access to their clinical/administrative/financial data through third- party apps of their choice. As the healthcare systems fully embrace digital health, the insights derived from such a longitudinal patient record will radically change healthcare economics and affordability, the ability to identify high-cost and high-need claimants, faster care gap closures. In so doing they will make it possible to arrest disease progression.

FHIR implementation is not just a “regulatory tick off” item!

Payers are well into the weeds of implementing the 2021 scope, but there are practical questions to be ironed out, which may result in clarifications to the existing rule. Payers will do well to prepare to address the 2022 scope – which is just around the corner. The FHIR journey has just begun. Be prepared for a long and bumpy ride!