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Payers Should Comply With the Interoperability Rules Now
By Dr. Chris Hobson

Payers are facing unprecedented times, with multiple pressures from the COVID-19 pandemic, calls to reduce inequity, political uncertainty around the long-term survival of the Affordable Care Act, and little consensus as to the likely model for health care funding and delivery after the 2020 election. Payers have invested heavily in moving their provider payment models from traditional fee-for-service to some form of a value-based care model in the belief that a more rational funding model will drive provider behavior in the direction of “value, not volume” of care. The calls to focus care on the needs of each individual patient and to increase patient involvement in health care decision making are now urgent, as are the competitive pressures to ensure plan members see value from their payer relationships.

The recently approved Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) Interoperability Rules (which implement the bipartisan recommendations of the 21st Century Cures Act) are intended to advance interoperability and patient participation across the board, and particularly to advance payer participation as key members of the health care system.

In light of all this, the new CMS and ONC rules should be viewed as technical strategic drivers to improve the patient experience, improve patient participation in their health care decision making, and provide a strategic focus for the evolution of payer business models.

Timelines have been established by Health & Human Services (HHS) for compliance with the new rules. The acute need to focus on the COVID-19 pandemic meant that implementation dates were moved back and that there may be further changes. As of writing, the key deadlines are April 2021 for public reporting and the information-blocking rule, May 2021 for ADT event notifications, July 2021 for patient-access application programming interface (API), and January 2022 for payer-to-payer data exchange. With many parts of the new rule not taking effect for some time, it may be tempting to wait before plunging into the work needed to ensure compliance, but payers must not make this mistake.

Payers who move ahead will have time to ensure their compliance and to build on the basic requirements into a truly patient-centric, market-leading solution. Conversely, payers who delay risk becoming entangled with the information-blocking rule, which includes stiff civil monetary penalties of up to $1 million per violation.

Baseline Requirements
HHS has made its expectations of the new rules clear: They are specifically designed to give patients access to their health care records. In announcing the rules, CMS Administrator Seema Verma stated that, “Putting patients in charge of their health records is a key piece of giving patients more control in health care,” and “We are holding payers to a higher standard while protecting patient privacy through secure access to their health information. Patients can expect improved quality and better outcomes at a lower cost.”

The CMS and ONC rules have bipartisan support in Congress. As such, even with potential political uncertainty on the horizon, payers should accept that these rules will be applicable for many years to come. The time to adopt is now.

Challenges
There are challenges in complying with the new rules. While the following challenges represent opportunities to improve the health care system, they should not be underestimated:

• An ongoing evolution of the standard. Compliance with the new rules will require payers to review and probably improve their technology capabilities as well as their data governance efforts. It is quite possible payers will find they do not currently house all the required data outlined in the United States Core Data for Interoperability (USCDI), or that they do not have the technical capability to surface that data in a Fast Healthcare Interoperable Resource, or FHIR, API. It would be far better to discover blockers early, allowing time to reach compliance comfortably before the deadline.

Additionally, perhaps in response to criticism that the USCDI data set version 1.0 is too narrow, ONC announced a process to vet and approve new data elements as part of USCDI’s future evolution. Given that this is an evolving process, it makes sense for payers to be involved as soon as possible.

In addition to the likely development of new data elements, there are functional gaps that will need to be addressed in future regulations. A great example of such a current gap is the write API. A write API is not specified in the regulations, yet it would make a significant contribution to patient empowerment by allowing patients to contribute data they personally generate back into the EMR. Payers should be beginning to plan for changes such as these, again highlighting the need to start soon.

• Patient empowerment should be a strategic goal for payers. Compliance with the new rules is the minimum step toward building a more patient-centric experience. In general, payers are already thinking in terms of ways they can improve their member experience, so patient access to data should be something they are already working on. Involving and empowering the patient will deliver improved clinical results and reduced costs. Consider, for instance, the lessons learned from COVID-19. During the pandemic, patient access to their lab results via a patient portal significantly reduced the load on providers to contact patients and tell them their results were negative.

• Information-blocking rules should not be underestimated. With civil monetary penalties of up to $1 million per violation, the costs of not complying are extremely high. We do not have the experience yet to indicate whether the Office of Inspector General (OIG) will take a strict approach to enforcement of this rule. Its stated priorities include conduct that resulted in patient harm or impacted a provider’s ability to care for patients. The OIG expects that its priorities will evolve with time and experience. As failing to share requested health information could easily result in patient harm on frequent occasions, payers should take compliance very seriously.

• Value-based care and outcomes that matter to patients. As noted earlier, payers have spent considerable time and effort working with their provider partners to enhance the use of provider payments linked to the delivery of actual value rather than simple performance of tasks. This is sometimes termed “the move from volume to value.” One of the major challenges of this model is agreeing on a definition of value in health care that addresses both payer and patient perspectives, as well as that of the providers.

There is an important intersection between the concepts of value-based care and patient empowerment. The ability of the health system to deliver appropriate care that leads to the achievement of patients’ personal goals and patient-desired outcomes is likely the correct measure of value in health care. This idea is proposed most prominently by the International Center for Health Outcomes Measurement and by Harvard Professor Michael Porter, PhD, who defines value in health care as “outcomes that matter to patients divided by the cost of delivering those outcomes.”

This represents a small but important adjustment to the standard description of value-based care, which leaves out the notion of patient-desired outcomes and assumes health outcomes can be adequately defined in standard ways applicable to all patients via the provider’s quality and performance measures.

Conclusion
Overall, the new rules sponsored by ONC and CMS are strategically aligned with other efforts across the United States to improve interoperability and patient participation in their care. Payers should view the new rules as technical strategic drivers to improving the service they provide to their members. Payers will officially need to comply with the regulations by mid-2021; however, given their close alignment with other trends in the evolution of health care, payers would be wise to commence work as soon as possible.

— Dr. Chris Hobson serves as chief medical officer for Orion Health.