On Feb. 11, 2019, two Department of Health and Human Services (HHS) agencies, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS), released their long-awaited proposed rules designed to further HHS’ goal of promoting electronic health information interoperability and implementing many of the provisions mandated under the 21st Century Cures Act (Cures Act). Notably, these proposed rules were released shortly before the HHS Office for Civil Rights deadline for comments about potential changes to improve coordinated care. Taken together, recent HHS rulemakings suggest that interoperability is coming, and significant requirements are in store for providers, payors, health information technology developers and players.

The Cures Act charged ONC with the responsibility of implementing many of the provisions designed to advance interoperability, including the provisions addressing information blocking and certification requirements for health information technology (health IT) developers. The ONC rule also contains widespread revisions to the agency’s Health IT Certification Program and the 2015 edition certification criteria to further support access to, exchange of and use of electronic health information.

As part of CMS’ MyHealthEData initiative, CMS’ goal is to move the patient-centered approach to health information access “to a system in which patients have immediate access to their computable health information and can be assured that their health information will follow them as they move throughout the health care system from provider to provider, payer to payer.” 84 Fed. Reg. 7610, 7611 (March 4, 2019). The proposed interoperability and patient access rule brings patients, payers and providers closer to having immediate access to all of the patients’ health and claims information.

ONC Proposed Rule

Updates to 2015 Edition Certification Criteria

Originally started in 2010, the ONC Health IT Certification Program is a voluntary certification program designed to help providers and other purchasers of health IT identify which products satisfy the standards and implementation specifications required for an electronic health record (EHR) or health IT model to obtain Certified EHR Technology (CEHRT) status. The ONC rule proposes significant changes to the 2015 Certification Criteria, including the removal of a number of criteria, revisions to existing criteria and the addition of several entirely new criteria. Unfortunately for those health IT developers that already have certified to the 2015 edition, the ONC rule would require recertification to the 2015 edition and the newly revised criteria. The time period for recertification varies, but some of these criteria changes must be recertified within six months of the final rule’s effective date.

New Criteria: Electronic Health Information (EHI) Export

One of the more significant proposed changes to the agency’s certification program is the addition of the Electronic Health Information Export criteria. Intended to provide patients and other health IT users an efficient means of exporting the EHI produced and maintained on health IT, these new criteria require developers to provide the capability to electronically export all EHI that the health IT systems produce and electronically manage in a computable format. While health IT developers would have the flexibility to determine their products’ export standards, the export file must be computable, and include publicly available documentation to allow for interpretation and use of EHI. Once the ONC rule is finalized, this requirement would become part of the criteria for 2015-edition certified IT and must be implemented within 24 months of the final rule’s effective date or within 12 months of certification for a health IT developer that never previously certified health IT to the 2015 edition, whichever is longer.

United States Core Data for Interoperability (USCDI)

Previously, ONC had established a standard of key health data that should be accessible and available for exchange, known as the Common Clinical Data Set (CCDS). ONC is now proposing to replace that with the updated U.S. Core Data for Interoperability (USCDI), which reflects the same data classes as CCDS but would add several new data classes and elements. If finalized, health IT developers will be required to update their certified health IT.

Application Programming Interface (API) Criteria

In 2015, ONC began issuing certification criteria for application programming interfaces (APIs). The ONC rule sets out new certification criteria, standards and implementation specifications for APIs, again with the focus on improving interoperability. Under the newly proposed API certification criteria, APIs would need to meet certain technical requirements, including use of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standards and access to and search capabilities for all USCDI data for single and multiple patients. ONC proposed several privacy and security requirements for APIs, such as allowing patients to limit the data they authorize the APIs to access.

Conditions and Maintenance of Certification

The ONC rule would also establish certain conditions and maintenance of certification requirements for the ONC Health IT Certification Program based on similar requirements outlined in the Cures Act. According to ONC, the proposed conditions of certification represent initial requirements for health IT developers and their certified health IT. The conditions of certification are accompanied by corresponding maintenance of certification standards that provide ongoing requirements, thereby ensuring that health IT developers not only meet the initial conditions but also continue to uphold certification requirements, similar to conditions of participation for Medicare providers. Seven conditions of certification have been proposed with accompanying maintenance of certification requirements, and many directly support the proposed new certification or implemented provisions of the Cures Act. For example, while the technical and security implementation requirements for API certification address the technical barriers to achieving interoperability, the API conditions of certification requirements seek to address the behavioral barriers by requiring that API technology suppliers make public the business and technical documentation necessary to interact with their APIs and setting limitations on the fees API technology providers may charge. ONC would be responsible for enforcing compliance with these requirements, including publicly terminating the certification of noncomplying entities and/or banning them from the certification program entirely.

Information Blocking

Perhaps no provision from the Cures Act begged greater clarification than the prohibition on information blocking by providers, health IT developers, health information exchanges or health information networks. The Cures Act broadly defined information blocking as “any practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information” and authorized HHS to create exceptions for activities that do not constitute information blocking. The ONC rule has identified seven such exceptions, including:

  • Preventing Harm.
  • Promotion the Privacy of EHI.
  • Promoting the Security of EHI.
  • Recovering Costs Reasonably Incurred.
  • Responding to Requests That Are Infeasible.
  • Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms.
  • Maintaining and Improving Health IT Performance.

Generally, these exceptions are structured into discrete subrequirements that must be satisfied to qualify for the exception. For example, for a privacy-protective practices exception, the entity’s actions must satisfy at least one of four subexceptions and meet all conditions applicable to a subexception being relied on. If the activity does not fall into an exception, the entity faces significant disincentives outlined in the Cures Act, including civil monetary penalties of up to $1 million per violation. Notably, ONC declined to lay out a penalty structure for information blocking violations, instead stating that each case is likely to be unique in nature and penalties will be decided on a case-by-case basis.

CMS Proposed Rule

Patient Access Through Application Programming Interfaces

CMS proposes to expand the MyHealthEData Initiatives for Medicare fee-for-service beneficiaries to require Medicare Advantage organizations, state Medicaid and Children’s Health Insurance Program (CHIP) fee-for-service programs, Medicaid and CHIP managed care plans, and Qualified Health Plan issuers to make health information accessible via the use of APIs, which would permit the patient to access his or her health information and payer information. If finalized as proposed, these entities would be required to provide their enrollees with electronic access by 2020. CMS also is proposing that the API technical standard proposed by the ONC use HL7 FHIR-based APIs to make patient claims and other health information available to patients through third-party applications and developers.

API Access to Published Provider Directory Information and Provider Digital Contact Information

CMS is proposing that Medicare Advantage organizations, Medicaid and CHIP fee for service and managed care publish a provider directory using an API. The creation of a provider digital contact index that can be used to facilitate information sharing among providers was a requirement put forth in the Cures Act.

Health Information Exchange and Care Coordination

CMS is proposing to require payers in CMS programs to support electronic exchange of data for transition of care as a patient moves between health plan types for such information as the individual’s provider, diagnosis, procedures and tests. The trusted network would verify the identity and security of the participants and would allow the payers and providers to join any health information network and be able to obtain patient information, regardless of the type of IT network.

Federal-State Data Exchanges

States and CMS routinely share data to support the administration of benefits to Medicare/Medicaid dually eligible beneficiaries. CMS is proposing to change the frequency of the exchange of data from a monthly to a daily basis. If finalized as proposed, all states would be required to participate in a daily exchange of data by April 1, 2022.

Information Blocking

CMS also addressed its concern about information blocking, or the practice of withholding data or intentionally taking action to limit or restrict the compatibility or interoperability of health IT, with the proposal to publicly report the names of clinicians and hospitals that respond negatively to certain attestation statements related to the prevention of information blocking. CMS is hopeful that publicly posting this information may deter healthcare providers from engaging in information blocking.

Medicare Conditions of Participation Revisions for Hospitals and Critical Access Hospitals

To enhance care coordination and transition, CMS is proposing that the Medicare Conditions of Participation for hospitals and critical access hospitals be revised to require Medicare participating hospitals to send electronic notifications to another healthcare provider when a patient is admitted to, discharged from or transferred from the hospital.

Patient Identifier and Interoperability

CMS has requested information from stakeholders regarding adoption of an individual identifier for healthcare purposes. Lack of a patient identifier inhibits interoperability efforts because it is difficult to ensure that the relevant records are all for the same patient and raises patient safety concerns.

Promotion of Certified Health IT Among Post-Acute Care Providers

CMS has requested information from stakeholders regarding how to promote the use of interoperable health IT among long-term care providers, home health agencies and other post-acute care providers. CMS noted that post-acute care providers were not eligible for the EHR incentive programs under the HITECH Act, and did not adopt CEHRT IT assets at the same rate that hospital and physician providers who were able to adopt CEHRT IT assets using CMS’ financial incentives.

Comments for the ONC and CMS proposed rules are due May 3, 2019.