Regulatory and Health Industry

Cures Act Interim Final Rule Compliance Timelines

On October 29, 2020, the Office of the National Coordinator for Health Information Technology (ONC) issued an Interim Final Rule extending the compliance dates for the agency’s Cures Act Final Rule. Below is a compilation of the original and revised compliance dates for the Cures Act Final Rule.

Read more about the extension at the Journal of AHIMA. Additionally, the October 2020 issue of the Journal of AHIMA featured a collection of articles that discussed implementing the information blocking and interoperability final rules.

 

Provision Final Rule Compliance date Enforcement Discretion-April 21, 2020 Interim Final Rule Compliance date
Information Blocking Applicability Date (Part 171) November 2, 2020 No Change April 5, 2021
Conditions of Certification—Information Blocking (§170.401) November 2, 2020 September 30, 2020 April 5, 2021
Conditions of Certification-Assurances (§170.402(a)(1) (will not take any actions that constitute information blocking or actions that inhibit access, exchange or use of electronic health information (EHI)) November 2, 2020 September 30, 2020 April 5, 2021
Conditions of Certification-assurances (§170.402(a)(2) and (3), and (b)(1))—Other Effective date: June 30, 2020 September 30, 2020 April 5, 2021
Conditions of Certification—Communications—(§170.403)—Communications requirements (does not include for §170.403(b)(1)) Effective date: June 30, 2020 September 30, 2020 April 5, 2021
Conditions of Certification—API (§170.404(b)(4)—Compliance for current API criteria November 2, 2020 February 2, 2021 April 5, 2021
Conditions of Certification—API (§170.404(b)(3))—Rollout of new standardized API functionality May 2, 2022 August 1, 2022 Dec 31, 2022
Conditions of Certification—Real World Testing—2015 Ed health IT certification criteria with standards updates May 2, 2022 3 months after compliance timeframe Dec 31, 2022
Conditions of Certification—EHI export rollout—(§170.402(b)(2) May 1, 2023 3 months after compliance timeframe Dec 31, 2023
Conditions of Certification—Assurances—(§170.402(a)(4) May 1, 2023 3 months after compliance timeframe Dec 31, 2023
Conditions of Certification—Communications—(§170.403(b)(1)) —-Notice to all customers with which developer has contracts or agreements containing provisions that contravene Communications Conditions of Certification Annually beginning in CY2020 Notice can be made until March 31, 2021 for CY20 Begin annual cycle 1 year later CY 2021
Conditions of Certification Initial Attestations—(§170.406) April 1-30, 2021 attestation window for attestation period running June 30, 2020-March 31, 2021 Generally remains the same except for the initial attestation, which will be accepted through July 30, 2021 Begin annual cycle 1 year later, CY2022. First attestation window will cover from effective date of final rule-March 31, 2022
Conditions of Certification Real World Testing—(§170,405(b)(1) and (2) submit initial plan and initial results submission Plan: December 15, 2020

 

Results: March 15, 2022

Initial plan: Initial real world testing plans may be submitted through March 15, 2021

 

Initial results: Initial real world testing results from 2021 performance year may be submitted through June 2022

Begin annual cycle 1 year later

 

Initial plan: Dec 15, 2021

 

Initial results: March 15, 2023

Definition of EHI constrained to US Core for Data Interoperability (USCDI) v1 November 2, 2020-May 1, 2021 April 5, 2021-October 5, 2022
Full definition of EHI May 2, 2021 October 6, 2022
Common Clinical Data Set (CCDS) permissibility in health IT modules 24 months after publication date of final rule December 31, 2022
 
2015 Edition Certification Criteria Update
ONC’s Interim Final Rule also extended the timeline for certain 2015 certification criteria. Below are the revised timelines for the criteria.

 

Certification criteria Reference Interim Final Rule Compliance Date Impact on CMS Promoting Interoperability Measures
Transitions of Care §170.315(b)(1) Update to adopted USCDI/C-CDA companion guide by December 31, 2022 -Support Electronic Referral Loops by Sending Health Information

 

-Support Electronic Referral Loops by Receiving and Incorporating Health Information

Clinical information reconciliation and incorporation §170.315(b)(2) Update to adopted USCDI/C-CDA companion guide by December 31, 2022 -Support Electronic Referral Loops by Receiving and Incorporating Health Information
Electronic prescribing §170.315(b)(3) Update to adopted NCPDP SCRIPT standard version 2017071 by December 31, 2022 -e-Prescribing

 

-Query of PDMP

Data export §170.315(b)(6) ONC-ACBs may only issue certificates for this criterion for the period before December 31, 2023 -Removed from 2015 Edition Base EHR definition effective date of the final rule (60 days after publication)
Security tags—summary of care—send §170.315(b)(7) Document, section, and entry (data element) level; or Document level for the period before December 31, 2022
Security tags—summary of care—receive §170.315(b)(8) Document, section, and entry (data element) level; or Document level for the period before December 31, 2022
Care plan §170.315(b)(9) Update to C-CDA companion guide reference in §170.205(a)(4) and §170.205(a)(5) by December 31, 2022
EHI export §170.315(b)(10) Certify to new criterion by December 31, 2023
Clinical quality measures (CQMs)—report §170.315(c)(3) Update to CMS QRDA Category I/III IG by December 31, 2022 PI Programs
Auditable events and tamper resistance §170.315(d)(2) Update to ASTM 2147-18 standard by December 31, 2022
Audit report(s) §170.315(d)(3) Update to ASTM 2147-18 standard by December 31, 2022
Auditing actions on health information §170.315(d)(10) Update to ASTM 2147-18 standard by December 31, 2022
View, Download, and Transmit to 3rd party §170.315(e)(1) Update to USCDI v1 and C-CDA companion guide referenced in §170.205(a)(4), and §170.205(a)(5) by December 31, 2022 Provide Patients Electronic Access to Their Health Information
Transmission to public health agencies—electronic case reporting §170.315(f)(5) Update to USCDI v1 by December 31, 2022 Electronic Case Reporting
Consolidated CDA creation performance §170.315(g)(6) Update to USCDI v1 and C-CDA companion guide referenced in §170.205(a)(4), and §170.205(a)(5) by December 31, 2022
Application Access—Data Category Request §170.315(g)(8) ONC-ACBs may only issue certificates for this criterion for the period before December 31, 2022 Provide Patients Electronic Access to Their Health Information
Application Access—All Data Request §170.315(g)(9) Update to USCDI v1 and C-CDA companion guide referenced in §170.205(a)(4), and §170.205(a)(5) by December 31, 2022 Provide Patients Electronic Access to Their Health Information
Standardized API for patient and population services §170.315(g)(10) Certify to new criterion by December 31, 2022 -Added to the 2015 Edition Base EHR definition

 

-Provide Patients Electronic Access to Their Health Information

 

This information was last updated 10/20/2020.