Following more than a month of silence from the U.S. Department of Health and Human Services (HHS) on the publication of its widely anticipated companion interoperability and information blocking final rules to the Federal Register, HHS’s Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS), in conjunction with the Office of the Inspector General (OIG), issued a joint statement announcing a policy of enforcement discretion to allow compliance flexibilities regarding the implementation of the final rules in response to the COVID-19 public health emergency.  The agencies indicated that they would continue to monitor the developing public health emergency to determine if further action is necessary.

OIG Proposed Rule

OIG issued an unpublished proposed rule amending the civil monetary penalty (CMP) regulations to include new CMP authorities for violations of ONC’s information blocking final rule.  OIG is seeking comment on when information blocking enforcement should begin, but has proposed to delay enforcement until 60 days after publication of the OIG’s final rule.  At a minimum, enforcement would not begin sooner than the compliance date for the ONC final rule established in 45 CFR § 171.101(b), which is November 2, 2020.

CMS Final Rule

CMS announced that the agency is extending the implementation timeline by an additional six months for certain components of its interoperability rule, including, for example, the admission, discharge, and transfer notification Conditions of Participation (CoPs).  In the unpublished version of CMS’ final rule, the agency initially stated these CoPs would be effective six months after the publication of the final rule.  Now, they will be effective one year after the final rule is published in the Federal Register – a date that is still to be determined.  CMS will implement and enforce other policies contained in the final rule on schedule.

ONC Final Rule

Earlier this week, ONC reissued the unpublished version of its final rule, which is now set for publication on May 1, 2020, with an effective date of June 30, 2020.  While the publication date triggers multiple compliance dates for various components of the interoperability and information blocking provisions (set at 60 days, 6 months, and 24 months following publication), the agency is changing that timeline for certain requirements in light of the COVID-19 crisis.  ONC has published new enforcement discretion dates and timeframes on its website.  We have summarized some key changes to the ONC final rule compliance timeline below.


ONC’s Initial Compliance Dates ONC’s Enforcement Discretion Dates
Certification
60 Days After Publication – June 30, 2020 (Effective Date)

  • Condition of Certification (CoC): Assurances – Other
  • CoC: Communications – Other
+ 3 Months – September 30, 2020
6 Months After Publication – November 2, 2020

  • CoC: Information Blocking*
  • CoC: Assurances – Information Blocking
  • CoC: Application Programing Interface (API) – Compliance by Certified API Developers with health IT certified to current API criteria

*but note that the compliance date for information blocking for all actors regulated by the ONC Final Rule remains the same, six months after publication (November 2, 2020)

+ 3 Months – February 2, 2021
24 Months After Publication – May 2, 2022

  • CoC: API – Rollout of new standardized API functionality
  • ONC-Authorized Certification Bodies (ONC-ACBs): Certification to Common Clinical Data Set (CCDS)/USCDI Criteria (only certify to CCDS for 24 months after final rule publication)
  • ONC-ACBs: Certification to Application Access – Data Category Request Criterion (only certify for 24 months after final rule publication)
+ 3 Months – August 2, 2022
36 Months After Publication – May 1, 2023

  • CoC: Assurances – EHI Export Rollout
  • ONC-ACBs: Certification to Data Export Criterion
+ 3 Months – August 1, 2023
Information Blocking
6 Months After Publication – November 2, 2020

  • Compliance starts for information blocking rules, including the exceptions
  • EHI definition is limited to USCDI
  • Enforcement to be delayed until OIG’s CMP rule becomes final; OIG currently proposes to delay enforcement until 60 days after publication of OIG’s final rule
No change
24 Months After Publication – May 2, 2022

  • Final EHI Definition in Effect
No change

Reed Smith is conducting a full review of the ONC and CMS final rules and will release shortly a client alert providing a detailed analysis of both.  In the meantime, please review our previous blog post for an overview of the final rules.

For questions regarding the final rules or this post, please contact Nancy Halstead, Nicole Aiken-Shaban, Vicki Tankle, Lauren Bentlage, or any Reed Smith attorney with whom you work.