The ACC has submitted formal comments to the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) addressing proposed rules related to information blocking requirements and advancing and improving electronic health record interoperability, respectively

In the letter to ONC, the College urges an interim final rule and continued work with stakeholders to mitigate administrative burdens, costs and unintended consequences on patients, providers and others. The letter also suggests a number of additional ways the ONC can work to strengthen the implementation of the interoperability and information blocking proposed rules, including:

• Providing additional clarity on definitions used in the rule, including health information exchanges (HIEs) and health information networks (HINs), and offering specific examples of actors ONC believes the information blocking provisions regulate
• Aligning Health Insurance Portability and Accountability Act (HIPAA) and EHI sharing requirements and providing sufficient regulatory clarity to ensure actors are aware of their responsibilities and of patients' rights to their information
• Working jointly with CMS and the Office of the Inspector General (OIG) to ensure that information blocking enforcement focuses on education rather than punitive action against non-malicious information blockers
• Ensuring patients are afforded every opportunity to clearly consent to the sharing of the health information and third parties protect information stored on behalf of an individual.

In comments to CMS, the ACC highlights the importance of the 21st Century Cures Act and the opportunities afforded to CMS and the ONC by the Act to make substantial progress in addressing the issues providers and patients have EHRs. "The creation of a health ecosystem that develops tools to allow patients to own and access their data has the potential to revolutionize care," the letter states. "The ACC applauds the efforts of CMS and ONC to start down this path."

However, the letter also notes the importance of considering related administrative and financial burdens placed on providers and other care givers as these efforts continue. "While the ACC encourages continued development of policies and technical standards that allow health information accessibility and transparency, the real costs and time needed to properly develop, install, and implement these systems should not be ignored," according to the letter.

Among the specific suggestions to CMS, the ACC urges the Agency to issue an interim final rule that "would allow all stakeholders additional time to process changes to the proposed rule, provide additional substantive feedback, and coordinate efforts to ensure the mistakes of previous programs like Meaningful Use are not repeated."

"The proposed rules by CMS and ONC represent a seismic shift in the Health IT landscape and patients and providers will need time to adjust. Implementing new health IT systems with additional capabilities, including expanded information sharing, will require substantial resources in both time and money expended by providers, practices, and health systems," the letters state. "Providers will be subject to new liabilities and penalties under the new electronic health information (EHI) and information blocking regulations. Patients will have access to their health information through third-party entities that may not fall under HIPAA protections. To protect patients and providers alike, it is essential CMS and ONC work jointly to slow down implementation, focus on education, and ensure the proper execution of these proposed rules."

Keywords: ACC Advocacy, Health Insurance Portability and Accountability Act, Meaningful Use, Medicare, Centers for Medicare and Medicaid Services, U.S., Information Dissemination, Medicaid, Thiadiazines, Electronic Health Records, Ecosystem, Informed Consent

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