Leveling the Playing Field in Health Information Sharing: Complying with the 21st Century Cures Act

The following is a guest article by Stephanie Jamison, Director of Regulatory Affairs, Greenway Health.

Since its passage in late 2016, the bipartisan 21st Century Cures Act has been setting the stage to reform the healthcare sector. Its broad, overarching goals include increasing patient choice and access to healthcare, streamlining development and delivery of innovative drugs and medical devices, accelerating research into serious illnesses, addressing the opioid crisis, improving mental health services, and more. As we move toward the value-based care model, the Cures Act also seeks to improve access to — and the quality of — information that Americans need to make informed healthcare decisions.

To that end, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) created rules to remove barriers associated with the use of electronic health record (EHR) systems and health information technology (HIT). By advancing interoperability of these systems and preventing information blocking, electronic health information (EHI) would be easily and seamlessly accessed, exchanged and used by patients and providers alike.

The ONC Final Rule lays out regulations to prevent information blocking practices by healthcare providers, health IT developers, health information exchanges (HIEs) and health information networks. The CMS Final Rule lays out similar expectations for healthcare payers like Medicaid Managed Health Plans and CHIP plans. Before passage of the rules, information blocking had become increasingly problematic as very large industry players operated in data silos, charging others exorbitant fees to access information, and making it difficult to share data across different platforms.

Information blocking requirements were scheduled to be enforced beginning in November of 2020, but due to COVID-19 priorities, the information blocking compliance date was pushed to April 5, 2021.

Overcoming Challenges with Information Blocking

While the rules are now in effect, there remains widespread confusion about information blocking. Nearly half (47%) of healthcare industry leaders said they were unfamiliar with information blocking, even though 70% indicated they were aware of the rules going into effect. Additionally, about half of all leaders say they are “using practices that are defined by ONC as information blocking,” such as charging patients fees to obtain records or sharing records via paper or CDs.

Surveys also show that many healthcare system stakeholders are still confused about rule requirements, as well as about what steps they need to take to ensure they can comply with the final rule. Patient data sharing is widely thought to be a technology issue, but the issue is instead largely policy-driven and requires institutional change as well as technological barriers being removed. For example, much like when the Health Insurance Portability and Accountability Act (HIPAA) rolled out a few decades ago, the ONC Final Rule is something that all parties involved in the healthcare ecosystem have to abide by — from providers and practices to health IT developers and payers.

For ambulatory care providers, Final Rule compliance may seem like an overwhelming process, and one that may require you to hire lawyers or compliance consultants to assist with. Especially since, at this time, there are no real defined processes, so it may seem difficult to ensure true compliance.

However, it may be of some assurance that, for the most part, existing EHR solutions contain what providers currently require for compliance. Until October 2022, EHI consists of those data elements that are included in version one of the U.S. Core Data for Interoperability (USCDI) data format.

In their rule, the ONC lists eight information blocking exceptions to recognize that there may be legitimate practical challenges limiting the ability to comply with requests for the access, exchange or use of EHI. For example, if a provider receives a request for a data element that currently isn’t captured in their EHR solution, it is infeasible for them to provide it. The “infeasibility exception” would apply in this instance.

Currently there are no penalties for providers for information blocking charges. However, the Office of the Inspector General is in the process of writing a proposed rule related to provider enforcement of violations, which is expected within this calendar year.

Preparing Your Ambulatory Care Practice to Meet New Healthcare Regulations

To ensure practices are fully prepared once enforcement rules are in place, now is the time to focus on establishing a process for evaluating information requests and ensuring staff members are knowledgeable about the exceptions. MGMA also offers a helpful Information Blocking Toolkit for Medical Groups to this end.

Use these and other tools to create a checklist, or series of checklists, that outline the information your practice needs to evaluate. These should account for the specific data requests, as well as the practice’s ability to provide that data. Also, for future reference, practices should get into the habit of documenting what was requested, the evaluation process and the response. Documentation, awareness of the exceptions and the ability to discern when they would apply when a patient requests EHI, are important steps to take in understanding the rule.

Even though it may seem complicated and overwhelming now, compliance with the ONC Final Rule on information blocking and overall interoperability will become easier as time goes on. Barriers built on disincentives for information sharing will be broken down to level the playing field, making it easier for patients and providers to access the information they need to provide better care and improved outcomes.

About Stephanie Jamison

Stephanie Jamison has over 15 years of experience in healthcare and health IT public policy. She currently serves as Greenway Health’s Regulatory Affairs Director, a position she has held since January 2019. In this role, she also represents Greenway on the Electronic Health Record Association (EHRA) as a member of the Executive Committee, which serves as the collective leadership voice for the association. Prior to joining Greenway, she held various public policy and regulatory affairs roles with WellCare Health Plans, HIMSS, the National Governors Association, among others.

   

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