AHIMA Comments on ONC and CMS Information Blocking Proposed Rules

This web-exclusive Journal column highlights public policy initiatives at the federal- and state-level that impact the HIM profession, including news on AHIMA’s national and affiliated state advocacy initiatives, Congressional updates, news from federal regulatory agencies, public policy updates from state legislatures, and AHIMA’s public policy initiatives with other organizations.


By Lesley Kadlec, MA, RHIA, CHDA

 

The past couple months have seen the announcement of a number of requests for comment from government agencies, and AHIMA’s Policy and Government Relations team has been hard at work developing the association’s responses.

On February 11, 2019, the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) released two proposed rules1,2 designed to improve the interoperability of electronic health information (EHI), increase patient access to electronic health information, and address “information blocking” practices as defined in the 21st Century Cures Act.3

Various aspects of these proposed rules are expected to have substantial implications across a broad spectrum of healthcare. Because of the significant impact on health information professionals, AHIMA submitted comments on both proposed rules.

In comments concerning ONC’s 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program proposed rule, AHIMA expressed concern about the lack of clarity and predictability around the definition of “electronic health information” as currently proposed—as well as the feasibility of operationalizing such a definition. As a result, AHIMA recommended that ONC constrain the definition of “electronic health information” to the US Core Data for Interoperability (USCDI).

AHIMA also expressed concern that the ONC proposed rule does not include sufficient guardrails around HIPAA non-covered entities to protect the privacy and security of a patient’s health information. AHIMA therefore recommend that as part of the certification criterion, ONC should require application programming interface (API) technology suppliers to verify an app’s “yes/no” attestation to:

  1. Industry-recognized guidance such as Xcertia’s™ mHealth App Guidelines
  2. Transparency statements and best practices including the Federal Trade Commission’s Mobile App Developers: FTC Best Practices and/or the CARIN Alliance’s Code of Conduct
  3. The adoption of either ONC’s Model Privacy Notice or a notice in plain language with content that is substantially the same as described in ONC’s Model Privacy Notice

Because the information blocking provisions of the proposed rule represent a fundamental shift that will require stakeholders to evolve from a mindset in which the sharing of health information is permitted under HIPAA to one in which EHI must be shared unless an exception applies, AHIMA recommended an 18- to 24-month delay of the effective date of the information blocking provisions in this proposed rule. A delay would provide healthcare organizations with the flexibility needed to make adjustments to existing business and organizational policies and practices to ensure compliance with the rule. Additionally, because the information blocking provisions in the proposed rule introduce a number of new definitions and terminologies, including expansive definitions—such as “electronic health information”—that require additional clarification from ONC before the entire rule is finalized, AHIMA also recommended that ONC consider issuing a Supplemental Notice of Proposed Rulemaking (SNPRM) to seek further comments on the proposed rule. AHIMA noted that issuance of a SNPRM would provide ONC with the desired flexibility to finalize certain aspects of the rule while concurrently issuing a SNPRM for the information blocking provisions of the proposed rule.

AHIMA’s detailed comments about specific aspects of the proposed rule can be found in Appendix A as an attachment to the general comments included in the letter.

AHIMA also submitted comments on CMS’ Interoperability and Patient Access proposed rule.

In this letter, AHIMA recommended:

  1. CMS consider note sharing as an “interoperability activity” for which eligible hospitals and critical access hospitals (CAHs) could receive credit in lieu of reporting the Provider to Patient Exchange measures.
  2. Further clarification as to whether a payer has an obligation to provide open API access to reopened and revised claims .
  3. CMS establish a clear deadline by which a payer should provide the USCDI data set to another plan upon an enrollee’s request.
  4. CMS clarify that the five-year timeline proposed under the rule will not alter existing federal and state record retention laws.
  5. CMS provide greater clarity around what it means to “incorporate” the data set into the recipient plan’s systems under the proposed rule.
  6. Prior to implementation of revisions to the conditions of participation for hospitals and CAHs, CMS work with ONC as part of ONC’s Health IT Certification Program to require that health IT systems be properly certified to send and receive electronic patient event notifications data as a condition of certification.

Additionally, as part of ONC and CMS’ Request for Information (RFI) on patient matching, which was included in both proposed rules, AHIMA underscored the need for data governance and data quality improvement policies and procedures that are fundamental to improving overall patient matching rates and data integrity in general. Rather than choosing to solely adopt a specific technological approach, AHIMA recommended that CMS consider requiring Medicare Fee-for-Service (FFS), the Medicare Advantage Plans, Medicaid FFS, Medicaid managed care plans, Children’s Health Insurance Program (CHIP) FFS, CHIP managed care entities, and qualified health plan issuers in federally-facilitated exchanges to annually evaluate their patient demographic data management practices using the Office of the National Coordinator (ONC)’s Patient Demographic and Data Quality (PDDQ) Framework. AHIMA also recommended, among other things, “that ONC work with industry and experts to identify other regularly collected demographic data elements that could be incorporated into the USCDI” to improve patient matching. Finally, AHIMA recommended that CMS work with ONC to develop, in coordination with stakeholders, a voluntary set of agreed-upon metrics to evaluate algorithm performance across the industry. Such metrics could be integrated into the certification criterion under the ONC Health IT Certification Program to help shed further light on the extent of variation in patient matching algorithms and create an opportunity for health IT developers to improve their algorithms.

You can read the full text comment letters in the AHIMA Body of Knowledge or by clicking on the links below:

  • 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program: http://bok.ahima.org/PdfView?oid=302761
  • Medicare and Medicaid Program; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in Federally facilitated Exchanges and Health Care Providers: http://bok.ahima.org/PdfView?oid=302760
References
  1. Department of Health and Human Services. “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program.” Federal Register(84 FR 7424), March 4, 2019. https://www.federalregister.gov/documents/2019/03/04/2019-02224/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification.
  2. Centers for Medicare and Medicaid Services. “Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-Facilitated Exchanges and Health Care Providers.” Federal Register(84 FR 7610), March 4, 2019. https://www.cms.gov/Center/Special-Topic/Interoperability/CMS-9115-P.pdf.
  3. 21st Century Cures Act. HR 34, 114th Congress, second session. 2016. https://www.gpo.gov/fdsys/pkg/BILLS-114hr34enr/pdf/BILLS-114hr34enr.pdf.
Lesley Kadlec (Lesley.Kadlec@ahima.org) is director, policy and state advocacy engagement at AHIMA.

Submit a Comment

Your email address will not be published. Required fields are marked *

Share This

Share This

Share this post with your friends!