Ashish Patel
February 15, 2022
The 40th Annual J.P. Morgan Healthcare Conference, January 10-13, brought strategic insights. This year, I spoke with Deloitte, specifically partners in the regulatory practice and leaders of the regulatory strategies group. This team seeks discussion with healthcare executives who look at the regulatory environment as input to strategy endeavors.As an industry as heavily regulated as healthcare, they approach the legislative and regulatory front from a practice perspective asking four questions: 1: “What are the regulatory white spaces created for stakeholders?” 2: “What regulatory and policy initiatives move against each other vs.
complement each other?”3: “How will payors, providers, and life sciences respond?”4: “How does a given initiative create opportunities or pain points in compliance?”Now, typically a year in advance, you know the “what” will happen.
It gives you, the healthcare leader, the chance to figure out the “how” for your healthcare organization. It starts with: “how many and what resources are we going to throw at this?” Let’s connect this to an example where the government helped trigger “disruption” in the Electronic Health Record (EHR) landscape with recent interoperability rules. There were two regulatory waves. First, in 2012, the Affordable Care Act’s (ACA’s) Centers for Medicare & Medicaid Services (CMS) interoperability rules. And then, in 2016, with the Office of National Coordinator for Health IT (ONC’s) information blocking rules featured in the 21st Century Cures Act.
Due to the pandemic, all citizens realized the consequences of these policies. Given these investments were already in place, providers easily adopted telemedicine and other advanced Health Information Technology (HIT) solutions. Phew. In the early days of Accountable Care Organizations (ACOs), there were bigger issues for payers, Medicare Advantage (MA) plans, and exchanges, with all the growth there. Now, you have to make claims and any data available via a Fast Healthcare Interoperability Resources (FHIR) based API. Already, there’s a trickle of this, as different organizations make use of the data.
Since the technical lift is so impactful, just to comply with the government programs, Health IT solution providers, payers, pharmacies, and providers are integrating FHIR into their strategy for all lines of business! On the provider side, new regulations are revamping the certification criteria for HIT. Starting in 2023, certified HIT products must have APIs that support access to patient data.
You and I, as patients, should be able to access and move information as we choose. Are patients getting direct access to electronic health information upon request? ONC’s anti-info blocking agenda focuses on releasing that clinical data.
The initial requirement went into effect on April 5, 2021, and on Oct 6, 2022, all clinical data should be in electronic format. Thus far, it's a good faith compliance effort, with no penalty mechanism. However, next month, March of 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG) will spell out the penalties for providers…The expectation is that info blocking penalties will be costlier than HIPAA violation penalties and reach up to $1M. This will definitely get the provider's attention. The initially proposed rule delay could be 60 days before it’s final. If the rules are published in March, July 1 will allow providers to comply. From a penalty perspective, OIG will not issue a penalty before Oct 6th when the expanded blocking ban goes into effect. Watch this space.
