Final ONC, CMS interoperability rules under review by OMB

Two major federal rules aimed at stopping information blocking and spurring data sharing are now one step closer to being finalized.

The Office of the National Coordinator for Health IT's (ONC) interoperability and information blocking rule is now under review at the Office of Management and Budget, the last step before publication. 

ONC delivered the rule to OMB Oct. 28, as first reported by Politico. ONC released its proposed information blocking rule (PDF) in February that outlines seven exceptions to the prohibition against information blocking and provides standardized criteria for application programming interface (API) development.

Despite calls by many industry groups to slow down and issue a supplemental notice of rule-making instead, ONC appears to be moving ahead with finalizing the rule. The rules were submitted to OMB as final rules, not interim final rules.

RELATED: Health IT stakeholders calling for ONC, CMS to 'go back to the drawing board' on interoperability rules

During a Senate Health, Education, Labor and Pensions (HELP) Committee meeting back in May, National Coordinator for Health IT Don Rucker, M.D., pushed back on changing the timelines, noting that the majority of providers have access to health IT software that meets the interoperability standards. "The risk of delaying this is that the American public is not in charge of their healthcare, are paying more for their care and not getting as good care as they could get," Rucker said.

The Centers for Medicare & Medicaid Services (CMS) proposed interoperability rule (PDF) also is under review at OMB. CMS delivered the rule to the agency on September 26. That rule would require insurers participating in CMS-run programs like Medicare, Medicaid, and the federal Affordable Care Act exchanges by Jan. 1 to have the capability to give 125 million patients electronic access to their personal health information at no cost to patients.

The new rules are a centerpiece of the 21st Century Cures Act and are designed to drive increased efficiency and transparency in healthcare through a variety of measures, including preventing information blocking and expanding how patients can access their healthcare information. Organizations that do not comply with the new regulations—which apply to essentially any organization handling patient medical records—could face substantial penalties.

The combined rules have the potential the shake up the industry and will have significant implications for healthcare providers, payers, and health IT vendors.

RELATED: Providers, payers unprepared for data blocking, interoperability rules: Accenture survey

Industry groups say the data blocking and patient access regulations, as proposed, will be a seismic shift for the healthcare industry and have voiced strong concerns about the implementation timelines. Seven major healthcare industry groups, including the American Medical Association, the Federation of American Hospitals and the Medical Group Medical Association, are calling for federal policymakers to make major changes to the proposed regulations, and to delay the publication of a final rule.

These same groups also have appealed to congressional leaders to help slow down the proposed interoperability rules, citing concerns about patient data privacy, the implementation timelines and increased burden on clinicians.

The American Medical Informatics Association says the proposed federal rules aimed at driving interoperability don't go far enough to put patients and providers in the driver's seat when it comes to accessing and exchanging health data. Another industry group, the Health Innovation Alliance, formerly Health IT Now, called for the recently proposed interoperability rules to be scrapped and rewritten.

RELATED: AMA, CHIME call for ONC to make major changes to data blocking regulation

Despite the major changes that are coming as a result of the ONC and CMS interoperability rules, a recent Accenture survey indicated most healthcare organizations lag in awareness and preparedness for compliance.

One in six (17%) healthcare executives are “completely unaware” of new legislation that requires greater patient access to healthcare records and sharing of such records—with two-thirds (65%) only “somewhat” or “vaguely” familiar, the Accenture survey found.

Of the healthcare executives surveyed, only 18% said they are “very familiar” with the implications of the regulations, the survey found.