Policy on the Move: Final Federal Interoperability and Patient Access Rules Information and Impact

This is a time of great health policy discussion and activity, especially given the challenge of COVID-19 and the finalization of significant federal regulations that will now move into the implementation stage. HL7 and its standards, such as Fast Healthcare Interoperabilty Resources (FHIR^®), are a strong fiber in these developments. Discussed here are key aspects of the final interoperability, patient access and information blocking rules recently released related to implementing provisions in the 21^st Century Cures Act (Public Law 114-155). The intersection of policy, HL7 standards and COVID-19 will be highlighted in this space soon. Stay tuned!

CMS and ONC published the final interoperability, patient access and information blocking rules in Federal Register May 1, 2020, with an effective date of June 30 this year. These rules focus on issues such as: value-based healthcare; enhanced care coordination; promoting patient access to, and control over, their health information; and improving the interoperability of electronic health information, primarily through standards-based application programming interfaces (APIs).

The CMS and and ONC final rules can be accessed at:

CMS

https://www.federalregister.gov/documents/2020/05/01/2020-05050/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-and

ONC

https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification

Importantly, accompanying these final rules was an announcement of enforcement discretion by both CMS and ONC. ONC said that, “In light of COVID-19, ONC will exercise its discretion in enforcing all new requirements that have compliance dates and timeframes until three months after each initial compliance date or timeline identified in the ONC Cures Act Final Rule.”

CMS noted that, “The Interoperability and Patient Access Final Rule includes policies that impact a variety of stakeholders.” It also outlined the three important final rule portions impacted in their enforcement discretion announcement:

• Recognizing that hospitals, including psychiatric hospitals and critical access hospitals, are on the front lines of the COVID-19 public health emergency, CMS is extending the implementation timeline for the admission, discharge, and transfer (ADT) notification Conditions of Participation (CoPs). CoPs at 42 CFR Parts 482 and 485 will now be effective 12 months after the final rule is published in the Federal Register.
• CMS finalized the Patient Access API and Provider Directory API policies for Medicare Advantage (MA), Medicaid, and the Children’s Health Insurance Program (CHIP) effective January 1, 2021. CMS will not enforce the new requirements under 42 CFR Parts 422, 431, 438 and  457 until July 1, 2021.
• CMS finalized the Patient Access API for Qualified Health Plan (QHP) issuers on the individual market Federally-Facilitated Exchanges (FFEs) beginning with plan years beginning on or after January 2021.  CMS will not enforce the new requirements under 45 CFR Part 156 until July 1, 2021.

CMS notes that other policies contained in the final rule will be implemented and enforced on schedule.

Updated and detailed schedules for final rule enforcement can be accessed at:

ONC Updated Schedule for Final Rule Enforcement 

https://www.healthit.gov/cures/sites/default/files/cures/2020-04/Enforcement_Discretion.pdf

CMS Enforcement Discretion Announcement (Consolidated with enforcement details):

https://www.cms.gov/Regulations-and-Guidance/Guidance/Interoperability/index

HL7 and its standards are foundational to the final CMS and ONC rules. This is particularly true in the area of APIs. ONC’s final rule establishes secure, standards-based application API requirements to support a patient’s access and control of their electronic health information. APIs are the foundation of smartphone applications (apps). As a result, patients will be able to securely and easily obtain and use their electronic health information from their provider’s medical record for free, using the smartphone app of their choice. CMS, in partnership with ONC, has also identified HL7 FHIR Release 4.0.1 in the final rules as the foundational standard to support data exchange via secure APIs.

In conjunction with ONC, the CMS Interoperability and Patient Access Final Rule requires health plans in Medicare Advantage, Medicaid, CHIP, and through the federal exchanges to share claims data electronically with patients in a safe, secure, understandable, user-friendly electronic format through the Patient Access API. 

HL7 is reviewing the final rules and will be providing its members and the broader healthcare community with implementation resources relating to these and other provisions. Look for links to those resources here and on hl7.org in the coming months.