By Cheryl Martin, MA, RHIA
On February 11, 2019, the US Department of Health and Human Services (HHS) unveiled new proposed rules to support seamless and secure access, exchange, and use of electronic health information (EHI). Two separate rules were proposed, one from the Centers for Medicare and Medicaid Services (CMS) and one from the Office of the National Coordinator for Health IT (ONC). Working in concert, the overarching purpose of the rules is to align payers, providers, and healthcare IT developers and to help drive an interoperable health IT infrastructure across systems.
“These proposed rules strive to bring the nation’s healthcare system one step closer to a point where patients and clinicians have the access they need to all of a patient’s health information, helping them in making better choices about care and treatment,” said HHS Secretary Alex Azar, in a press release. “…These steps forward for health IT are essential to building a healthcare system that pays for value rather than procedures, especially through empowering patients as consumers.”
Some of the major HHS intended outcomes from the proposals are:
- Seamless and secure access, exchange, and use of EHI
- Increased choice and competition, fostering innovation that promotes patient access to and control over their EHI
- Helping patients’ caregivers and healthcare providers securely access and share health information
The rules were submitted to the Office of the Federal Register for publication and were published Monday morning, March 4. Now the Notice of Public Rule Making (NPRM) 60-day comment window begins. This article provides an overview of each rule, highlighting the key points in each.
AHIMA’s Advocacy Team is working with partners in Washington, DC to draft AHIMA’s reaction to both rules. But AHIMA needs to hear from you to ensure the association is speaking on your behalf. What do you like about the proposed rules? What concerns you? It is important to share both so the association can address what needs improvement in the rules while also speaking up for what is good and should remain intact.
CMS Proposed Rule: Interoperability and Patient Access Proposed Rule
Aspects of CMS’ proposed “Interoperability and Patient Access Proposed Rule” include:
- Supports myHealthEData initiative
- Increases the seamless flow of health information
- Decreases the burden on patients and providers
- Fosters innovation by unleashing data for researchers and innovators
- Proposes requiring Medicaid, CHIP, Medicare Advantage Plans and Qualified Health Plans in the Federally Facilitated Exchanges to provide enrollees with immediate electronic access to claims and other health information by 2020.
- Implement open data sharing technologies that support transitions of care
- Publicly reports providers or hospitals that participate in information blocking.
- Defines interoperability with respect to health IT as technology that:
- Enables the secure exchange of EHI with and use of EHI from other health IT without special effort on the part of the user
- Allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable state or federal law
- Does not constitute information blocking
Information blocking is defined as practices that unreasonably limit the availability, disclosure, and use of EHI to improve interoperability. There are seven exceptions to the Information Blocking Provisions, according to the proposed rule. These exceptions are categories of practice that would be reasonable and necessary provided certain conditions exist. These exceptions are listed below with very brief descriptions. There is a significant amount of explanation and definition included in the ONC proposed rule that goes into much further detail.
- Preventing Harm: Acknowledges that the public interest in protecting patients and other persons against unreasonable risks of harm can justify practices that are likely to interfere with access, exchange, or use of EHI.
- Promoting the Privacy of EHI: Advances the goal of preventing information blocking for improper or self-interested purposes while maintaining and upholding the privacy rights that patients now have.
- Promoting the Security of EHI: Allows the mitigation of security risks and implementation of appropriate safeguards to secure the EHI.
- Recovering Costs Reasonably Incurred: Acknowledges that one should be able to recover costs that they reasonably incur to develop technologies and provide services that enhance interoperability and promote innovation, competition, and consumer welfare.
- Responding to Requests that are Infeasible: Acknowledges that there may be legitimate practical challenges beyond the control of the requestee that may limit their control and ability to comply with requests for access, exchange, or use of EHI.
- Licensing of Interoperability Elements on Reasonable and Non-Discriminatory Terms: Allows those who control the technologies to protect the value of the innovations and earn returns on the investments they have made to develop, maintain, and update these innovations.
- Maintaining and Improving Health IT Performance: “…recognizes that it may be reasonable and necessary to make health IT and in turn EHI unavailable for the benefit of the overall performance of the system.”
ONC Proposed Rule: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
Aspects of the ONC’s “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” proposed rule include:
- Information to be made available to patients at no cost
- Promotes secure and immediate access to health information for patients and their providers and new tools allowing for more choice in care and treatment
- Calls on the industry to adopt standardized application programming interfaces (APIs), which will allow individuals to easily access structured and unstructured EHI formats using smartphones and other mobile devices
- APIs will be developed using FHIR standards
- Implements the information locking provisions of the 21st Century Cures Act
- Supports Executive Order 13813 – Promoting Healthcare Choices and Competition
- Supports Executive Order 13771 – Reduce Regulation and Control Records
- Supports Executive Order 13777 – Endorse the Regulatory Reform Agenda
- Updates the 2015 Edition Certification Criteria to ensure certified IT systems can:
- Send and receive EHI in structured formats
- Ensure the EHI is available without special effort through the use of APIs
- Export the EHI from health IT systems to any location designated by the patient
The ONC proposed rule also has two associated Requests for Information (RFIs):
- Asks for comments in pricing that can be included as a part of a person’s EHI and would help the public see the prices they are paying for their healthcare.
- Asks how standards-based APIs might support improved information exchange between a healthcare provider and a registry in support of public health reporting, quality reporting, and care quality improvements.
Public input on these RFIs may be considered for future HHS rulemaking.
Both proposed rules align to enhance interoperability in important ways. Each proposes:
- The use of the same API standards—FHIR.
- The inclusion of the United States Core Data for Interoperability Standard (USCDI). This standard addresses the content, vocabulary, and delivery of clinical data.
There will be ongoing analysis provided by AHIMA regarding the potential impact the proposed rules will have on the health information management profession specifically, as well as impacts at a macro level in the industry. Please share your comments about the rules—both what you like and what you are concerned about—with AHIMA at email@example.com.
As the collective voice of AHIMA regarding public policy, AHIMA’s Advocacy Team wants to understand what AHIMA members have to say about these proposed rules. The team will share this information with AHIMA’s Board of Directors to help determine the association’s response during the 60-day response time frame, which ends May 3, 2019. Giving voice to your opinions is very important!
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