Industry Stakeholders Express Concerns With ONC, CMS Interoperability Regulations

Nov. 13, 2020
The top issues that are impacting readiness to comply include needing to focus on COVID-19, too many competing priorities, and not enough time for implementation, according to a new survey

A recent survey from the eHealth Initiative (eHI) on industry readiness to meet the requirements of the ONC Cures Act and CMS Interoperability and Patient Access final rules reveals a wide range of stakeholder concerns.

Released to the public on March 9, senior healthcare officials from the Trump administration dropped two significant final regulations around interoperability and patient access, one coming from the Office of the National Coordinator for Health Information Technology (ONC), and the other from the Centers for Medicare & Medicaid Services (CMS). Broadly, the two rules clarify issues around information blocking, and promote the development of a nationally consistent patient access API (application programming interface) concept, designed to make access to their electronic health records (EHRs) available to all patients through their smartphones. The regulations apply to all hospitals, physicians, and health plans that receive any reimbursement through either the Medicare or Medicaid programs.

On the payer side, the final rule requires CMS-regulated health plans to provide access to provider and patient claims and clinical data via APIs. Plans must also make sure that their IT systems can communicate with third-party users, which include consumer health apps. The CMS rule also mandates that all that payers in CMS programs be required to participate in a health information network of their choosing.

On the provider front, key elements of the ONC rule are related to API standards, EHR certification, and EHR vendor business practices and behaviors. It also has a significant section devoted to information blocking with potentially hefty fines for violators.

The eHI survey was conducted over a one-month period in August, and included 189 respondents—25 percent providers, 22 percent vendors, and 9 percent payers. Other respondents included those with associations, federal agencies, and consultancies. Almost half (45 percent) of the respondents were in executive/senior management roles.

How familiar are stakeholders with the CMS final regulation? The survey found that 53 percent of respondents are very or extremely familiar with the rule, while 26 percent are at least somewhat familiar. The “very or extremely familiar” response rate jumped to 75 and 79 percent when filtered out by just vender and just payer respondents, respectively.

As far as if respondents would prefer if the compliance deadlines get pushed back, 72 percent, industry-wide, said they probably or definitely would want them to get delayed.  To this end, due to the COVID-19 pandemic, federal health officials recently decided to extend the deadlines for stakeholders to comply with a variety of information blocking and other health IT-related mandates in the ONC rule, by five months in some instances, and a whole calendar year in others. CMS has also delayed the compliance deadlines for implementing the Patient Access and  Provider Directory APIs until July 1, 2021.

Other key survey findings include:

  • Payers, providers, and vendors each identified implementing and maintaining the Patient Access APIs as a top area of concern (43 percent)
  • Providers indicated the greatest impact of COVID-19 on their readiness (57 percent) in comparison to the other groups. More than 8 in 10 providers said that COVID-19 has at least moderately impacted their readiness.
  • 47 percent of the respondents indicated preparedness to meet the applicability date
  • The biggest data challenges to overcome are lack of data standardization (47 percent), lack of technical operability (44 percent) and shared data quality (44 percent)
  • 44 percent of respondents identified that readiness is most impacted by the lack of prioritization across the industry due to internal competing priorities
  • Payers and providers are most concerned with cost in choosing a vendor, with the former more willing to accept vendor assistance than the latter
  • As far as top interoperability initiatives already underway, 45 percent of respondents said the HL7 FHIR (Fast Healthcare Interoperability Resources) standard, 42 percent said secure messaging, and 42 percent said CCDA (Consolidated-Clinical Document Architecture).

“Despite the recent delays that push back the applicability date of many of the requirements in the Final Rules, the results reveal that payers, providers, and vendors have several areas of concern related to readiness,” said Jen Covich Bordenick, CEO of eHI. “For example, providers have been most significantly impacted by the current pandemic, but all stakeholder groups remained concerned about the capability to implement and maintain Patient Access APIs.”

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