Countdown to Compliance
Compliance with ONC’s Info Blocking Rule Goes into Effect on November 2nd
Compliance for the Information Blocking provisions of the ONC Final Rule for all Actors (Developers of Certified Health IT, HIEs/HINs, and Providers) is required by November 2, 2020, 6 months after ONC Final Rule publication.
The timing of enforcement is less clear. The HHS Office of the Inspector General (OIG) will not finalize its enforcement timetable for Civil Monetary Penalties (CMPs) for Developers and HIEs/HINs pending a forthcoming Final Rule (based on a April 24, 2020 Proposed Rule). The OIG’s primary timing proposal was for enforcement to begin 60 days after publication of a Final Rule, but no earlier than the ONC compliance date. This proposal is subject to change.
For Developers, ONC has announced a three months enforcement discretion period for information blocking certification provisions (and other certification provisions in its Final Rule). This enforcement discretion does not now affect the OIG CMP timetable.
For Providers (who are not subject to ONC oversight or OIG CMPs), enforcement timing will depend on forthcoming (but not yet scheduled) rulemaking that will address additional information blocking “disincentives” for Providers as well as the federal agencies to which OIG will refer Provider-focused information blocking complaints.
In the face of this uncertainty, and with recognition of the complexity of implementation and compliance planning, a rapidly approaching compliance date, and the acute need for wide data access, The Sequoia Project believes it prudent for organizations subject to the information blocking regulation to target their preparedness efforts on November 2.
Information Blocking Guidance to the Health IT Community
Gain Actionable Implementation Guidance and Feedback
In May 2019, a Phase 1 deliverable was released with formal comments on the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology’s (ONC) Proposed Rule on implementation of provisions of the 21st Century Cures legislation. A Phase 2 deliverable, focused on the implementation and implications of the ONC’s Proposed Rule and potential outcomes, is now available. The full report includes a complete summary of discussions and observations from Workgroup members.
Additional Information Blocking Resources:
Information Blocking and Interoperability Final Rules Are Here: Now What?
(A Public Webinar, 03.31.2020)
Follow-Up Information Blocking and Interoperability Final Rules Webinar: Featuring Extended Q&A
(A Public Webinar, 04.17.2020)
HHS OIG Proposed Rule on Information Blocking Enforcement & Monetary Penalties
(A Public Webinar, 06.11.2020)
Information Blocking Guidance to the Health IT Community
In advance of the publication of U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) final information blocking rules, The Sequoia Project has released “Guidance to the Community and Implementation Feedback to HHS.” The guidance was developed by a cross-industry Information Blocking Workgroup formed to provide input into The Sequoia Project’s comments to the ONC on the proposed rules, identify practical implications of proposed and final information blocking rules, and facilitate discussions to clarify information blocking policies before and after the Final Rule.
“Given the broad and significant impact the rules would have to the health information sharing community, we formed the Information Blocking Workgroup. Working collaboratively to interpret and apply the rules will be important to fostering cooperation as the community prepares for ONC and OIG [Office of Inspector General] enforcement,” said Mariann Yeager, CEO of The Sequoia Project.
The Work Group addressed implementation-related aspects of priority components of the information blocking regulation, including:
- Regulatory Definitions (e.g., Health Information Exchange and Health Information Network);
- Information Blocking Practices;
- Recovering Costs/Licensing Exceptions; and
- Compliance Plans and Implementation Plans.
The Workgroup consists of engaged experts, regardless of The Sequoia Project membership. Co-Chairs David Camitta, of SpiritHealth, and Paul Uhrig, of Surescripts, led the workgroup with the support of co-facilitators Mark Segal, of Digital Health Policy Advisors, and Steve Gravely, of Gravely Group. Representatives from diverse sectors of health information technology were included in the workgroup, including:
- Associations and organizations in the health IT community;
- Consumer organizations;
- Federal government agencies;
- Health information networks and service providers;
- Healthcare providers and physicians;
- Legal, technology, standards, and policy subject matter experts;
- Payer organizations;
- Public health organizations;
- Health IT vendors;
- Informatics organizations;
- Safety net providers and service providers; and
- Release of information companies.
A previous Phase 1 deliverable of the workgroup was provided to the ONC in May 2019 as formal comments on ONC’s Proposed Rule implementing provisions of the 21st Century Cures legislation, including information blocking. Today’s guidance is considered a Phase 2 deliverable, focused on implementation and implications of the ONC’s proposed rules and potential outcomes. During Phase 3, which began in January 2020, the Work Group will review the Final Rule and identify and address priority implementation topics and approaches.
“This report aims to be a guide for the community. Implementation guidance is essential to reduce uncertainty and prepare for compliance.”