Electronic Health Reporter

By Scott E. Rupp, publisher, Electronic Health Reporter.

On March 21 HIMSS representatives vice president of government affairs, Tom Leary, and senior director of federal and state affairs, Jeff Coughlin, hosted a roundtable with members of the media to peel back a few layers of the onion of the newly proposed ONC and HHS rules to explain some of the potential ramifications of the regulations should they be approved.

The CMS proposed regulation is attempting to advance interoperability from the patient perspective, by putting patients at the center of their health care and confirming that they can access their health information electronically without special effort.

ONC’s proposed regulation calls on the healthcare community to adopt standardized application programming interfaces (APIs) and presents seven reasonable and necessary conditions that do not constitute information blocking.

According to HIMSS’s assessment of both proposals there’s room for interpretation of each, but the organization has not yet fully formed a complete response to each as of this writing.

However, Leary said: “It’s important to emphasize that all sectors of the healthcare ecosystem are included here. The CMS rule focuses on payer world. The ONC rule touches on vendors and providers. All sectors really are touched on by these rules.”

With both, ONC and CMS is trying to use every lever available to it to push interoperability forward and is placing patients at center, Coughlin said. The healthcare sector got a taste of how CMS plans to empower patients through its recent MyHealthEData initiative, but the current proposal places more specifics around the intention of agency. Likewise, the ONC rule is attempting to define the value of the taxpayer’s investment in regard to the EHR incentives invested in the recent meaningful use program.

Key points of the rules

Some key points to consider from the rules: APIs have a role to play in future development of the sector and are seen as a real leveler of the playing field while providing patients more control of their information, Coughlin said.

HHS is focusing on transparency and pricing transparency. For example, there’s movement toward a possibly collecting charge master data from hospitals and, perhaps, publishing negotiated rates between hospitals and payers, which HHS is looking into.

What happens now that rules are out? According to HIMSS, education members is the first step to understanding it and responding to the federal bodies. “What we’ve done is focus on educating HIMSS members in briefings,” Coughlin said. “Trying to get early feedback and early impressions from members, convening weekly conference calls to address parts of the rule. Once we have critical mass then we work with executive leadership to make sure what we are hearing from membership to is reflected across the membership.”

Looking into the future?

For health systems, the broad exchange of data likely remains a concern. Data exchange within the ONC rule impacts providers and health systems in a number of ways, especially in regard to the costs of compliance to meet all of the proposed requirements.

HIMSS representatives are not currently casting a look into a crystal ball or if they are (they are), they’re not yet ready to tip their hand regarding what the organization intends to pursue through its messaging on behalf of its members.

“We’re not in a place to see where we are going to land,” Coughlin said. “We are hearing from our members about the complexities of rules and what’s included. It’s hard to overestimate how complex this is. ONC and CMS in designing broader exchange of information is something that speaks very well of them, but (this is) complex in interpretation and implementation.”

Information blocking exceptions, the default is broader sharing of information across the spectrum. More information has to be shared and expectations need to be defined, they said. From HIMSS’ perspective, compliance is the primary issue of its members. The question that needs answering is what kind of burden is being placed on health systems and providers. Leary is confident HIMSS will spend a good bit of ink in its response on citing potential concerns over information blocking and what that might mean.

“It will be helpful for the community to have examples and use cases for what’s included especially for exceptions for information blocking,” Coughlin said. “We need examples to clearly define the difference between health information exchange and health information network.”

Details of each rule

According to HIMSS, the ONC is proposing an approach where the Conditions and Maintenance of Certification express the initial and ongoing requirements for health IT developers and their certified Health IT Modules as part of the Health IT Certification Program. However, ONC is taking certification to a higher level beyond the technical and functional requirements to also include the conditions or requirements that health IT developers should also be held to, including:

• Information blocking: Must not take any action that constitutes information blocking.
• Assurances: Must make certain assurances to not take any action that may inhibit the appropriate exchange, access and use of electronic health information as well as assurances regarding retaining records that demonstrate initial and ongoing compliance with the requirements of the Certification Program.
• Communications: Expressed colloquially as “gag clauses,” a developer must not prohibit or restrict communications regarding the usability, interoperability, or security of its health IT, including relevant information regarding users’ experiences when using its health IT or the manner in which a user of the health IT has used such technology.
• APIs: An API technology supplier must publish APIs and must allow health information from such technology to be accessed, exchanged, and used without special effort through the use of APIs or successor technology or standards. In addition, any and all fees charged by an API Technology Supplier for the use of its API technology must be described in detailed, plain language.
• Real-world testing of certified health IT: A health IT developer with Health IT Modules to be certified to any one or more 2015 Edition certification criteria must successfully test the real-world use of those Health IT Modules for interoperability in the type of setting in which such Health IT Modules would be/are marketed. A developer must submit an annual real-world testing plan no later than December 15 of each calendar year.
• Attestations: A health IT developer must provide an attestation of compliance with the Conditions and Maintenance of Certification requirements, including specifically attesting to not taking any action that constitutes information blocking or any of the other previously discussed requirements.

ONC is also planning to implement an additional future condition and maintenance of certification requirement that is focused on an electronic health record (EHR) reporting criteria submission

Likewise, the Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health IT (ONC) released proposed regulations that focus on ensuring that health information is shared across the entire care continuum, including with patients. CMS is trying to put patient data at the center of their healthcare and confirm that they can access their health information electronically without special effort. The ONC wants standardized application programming interfaces (APIs) and presents conditions that do not constitute information blocking.

The CMS proposal would require payers — Medicare Advantage Plans, Medicaid, Children’s Health Insurance Programs, and qualified health insurance plans in Federally-facilitated exchanges – to deploy standardized, open APIs to make certain information available to enrollees.

Comments on the proposed rule are due by 11:59 p.m. ET on May 3, 2019. HIMSS said it would post its comments for public consumption on May 2.