New Enforcement Deadlines for Interoperability and Data Barriers: A Guide for Healthcare Providers, Insurance Companies, and IT Developers
The U.S. Department of Health and Human Services (HHS) has introduced new rules aimed at enhancing healthcare access and exchange, focusing on interoperability and reducing information blocking. Here's a summary of the key changes.
On May 1, 2020, the Office of the National Coordinator for Health Information Technology (ONC/ASTP) and the Centers for Medicare & Medicaid Services (CMS) published the ONC Interoperability, Information Blocking and Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access Final Rule in the Federal Register.
These rules introduce new requirements for healthcare providers, payers, health IT developers, and health information exchanges and networks.
Healthcare Providers
Healthcare providers that meet the definitions of Health Information Networks (HINs) or Health Information Exchanges (HIEs) may be subject to civil monetary penalties (CMPs) once the Office of Inspector General (OIG) finalizes its proposals. However, these penalties have not yet been implemented.
Payers
Payers participating in Medicare Advantage, Medicaid, the Children's Health Insurance Program (CHIP), and Qualified Health Plans (QHP) on the Federally-facilitated Exchanges (FFEs) are subject to new data access and exchange requirements under the CMS Final Rule.
Covered payers must implement and maintain a secure, standards-based API for patient access to claims and encounter information by January 1, 2021, but enforcement will not begin until July 1, 2021. They must also make provider directory information publicly available via a standards-based API by the same date.
Additionally, covered payers must exchange certain patient clinical data with other payers at the patient's request beginning January 1, 2022.
Health IT Developers
Developers of certified health IT will need to comply with the new ONC standards for obtaining and maintaining certification. Certain compliance dates have been pushed back until April 5, 2021.
Information Blocking
The ONC Interoperability, Information Blocking and Health IT Certification Program Final Rule establishes new federal penalties to deter the practice of information blocking. Payers, healthcare providers, health IT developers, and health information exchanges and networks may be subject to CMPs for knowingly interfering with the access, use, or exchange of Electronic Health Information (EHI).
The OIG proposes to impose CMPs—up to $1 million per violation—on those actors found to have knowingly interfered with the access, use, or exchange of EHI under the Cures Act CMP authority.
Enforcement
The U.S. Department of Health and Human Services (HHS), specifically its Office of Inspector General (OIG) together with the Office of the National Coordinator for Health Information Technology (ONC/ASTP), will track information blocking by these actors and impose CMPs once the final rule for enforcement is published and effective.
However, for providers subject to the new Medicare Conditions of Participation, enforcement will be delayed 12 months (until May 1, 2021). While a provider-specific information blocking enforcement policy is being developed, healthcare providers may still be subject to other adverse action if practices violate HIPAA right of access or Medicare payment rules.
Delayed Enforcement
Enforcement of some requirements has been delayed until July 1, 2021, due to the COVID-19 pandemic. This includes the enforcement of the CMS Interoperability and Patient Access Final Rule and the ONC Interoperability, Information Blocking and Health IT Certification Program Final Rule for payers and healthcare providers.
The OIG proposed a rule implementing new CMP authorities, including the Cures Act CMP authority, on April 21, 2020. However, the final rule for enforcement has not yet been published.
These new rules aim to improve the access, use, and exchange of health data, ultimately benefiting patients by ensuring they have access to their health information and can easily transfer it between providers and payers.
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