May 20, 2019
Don Rucker, MD
National Coordinator for Health IT
Mary E. Switzer Building, Mail Stop: 7033A
330 C Street, S.W.
Washington, DC 20201
Attention: RIN 0955-AA01
Dear Dr. Rucker:
Thank you for the opportunity to comment on the 21st Century Cures Act: Interoperability, Information Blocking and ONC Health IT Certification Proposed Rule. The National Committee for Quality Assurance (NCQA) overall strongly supports this proposed rule to promote electronic data exchange and stop data blocking to improve health care quality.
Along with the aligned Centers for Medicare & Medicaid Services (CMS) proposed rule for improving interoperability and patients’ access to their data, your proposals will bring the promise of health IT much closer to its full potential. Together, the proposed rules also support the goal of automatically extracting quality measurement data from electronic health records (EHRs), registries, health information exchanges (HIEs) and other electronic health information (EHI) sources. Automatically extracting quality measurement data from electronic sources can reduce reporting burden, improve the accuracy of results and support measures that are more meaningful than traditional reporting based on claims data. This is a top priority for NCQA and many other stakeholders.
We do believe, however, that some provisions of the proposed rule can be improved.
- Current quality measure reporting via electronic systems does not sufficiently ensure the accuracy and validity of results. We therefore urge you to require certified reporting systems to undergo annual certification via NCQA’s ONC Authorized Testing Laboratory (ATL), which is substantially more robust than ONC’s Project Cypress tool.
- For EHI export, we urge you to establish a “gold standard” Continuity of Care Document (CCD) export that patients can obtain from any system and take to any other system. Without this ability, exporting—in any format—may be no more useful than carrying paper medical records from one clinician or facility to another.
- We support adopting Health Level 7’s (HL7) Fast Healthcare Interoperability Resources (FHIR) application programming interface (API) criterion, but note that there are multiple versions. You will need to ensure that all systems use the same version for certification and implementation purposes.
Detailed comments on these and other issues in the proposed rule are below.
Updates to the 2015 Edition Certification Criteria: We support the proposed updates, including adopting the US Core Data for Interoperability Standard (USCDI) to replace the Common Clinical Data Set. USCDI includes more than just clinical data, enjoys broad support, will help make EHI readily available and is moving in the right direction.
However, both FHIR and USCDI are works in progress and will need substantial improvement to fulfill their promise. For example, these standards do not yet include fields for data on social determinants of health, risk adjustment and stratification, care plan goal progress, care coordination, care transitions and opioid use. In addition, not all systems are ready to use these standards. We appreciate that there is a need to balance progress toward comprehensiveness with the ability of different stakeholders to adapt to these standards. We therefore urge you to incorporate any and all updates as quickly as feasible if your final rule adopts these broadly supported standards.
We also specifically support requiring adherence to HL7 Unique Device Identifier implementation guidance, and replacing “Medication Allergies” in USCDI with a new “Substance Reactions” data class that includes medication allergies and SNOMED Clinical Terms for
EHI Export: We understand that health IT vendors need sufficient space for innovation. However, we strongly encourage ONC to establish an implementation guide for Continuity of Care Document (CCD) export that patients can obtain from any system and take to any other. The implementation guide should limit optionality that allows omission of key data needed for measurement and good clinical care across settings, and specify where structured data is preferred over unstructured data, similar to what CMS does with its QRDA implementation guide. Without this guide, exporting in any format may be no more useful than carrying paper records from one clinician or facility to another.
ONC Health IT Certification Modifications: We strongly agree with requiring authorized certification bodies to accept test results from any ONC-Authorized Testing Laboratory (ATL), which includes NCQA. We urge you to clarify that ONC-ATL records retention includes “life of the edition,” as well as after retirement of an edition related to certification of Complete EHRs and Health IT Modules.
Data Blocking: We strongly support the proposed provisions to prohibit health IT vendors from blocking the sharing of electronic data. Data blocking harms patients by preventing information from flowing to where it is needed for optimal care, and impedes efforts to extract clinical quality measure reporting data from EHI sources.
We also support requiring developers to participate in health information networks that are part of the Trusted Exchange Framework and Common Agreement (TEFCA), for assurance that they are not blocking data. However, we do not support centralizing TEFCA authority and operations into a single Recognized Coordinating Entity (RCE). We support the idea that the RCE, as a third-party, independent evaluator, would evaluate the operational and organizational aspects of health information networks, but we do not believe the RCE should also function as the tester and authorizing body for technical standard conformance.
We recommend building a multi-stakeholder advisory council to guide the RCE to function as a convener, collaborator and consensus-builder working transparently with appropriate stakeholders to identify issues and solutions.
Price Transparency: We further support the suggestion that ONC could establish a framework to prevent blocking of price information. We encourage you to develop an expansive set of EHI that includes information on health insurance eligibility, benefits, billing and price information, to the greatest extent feasible.
Opioids: We believe ONC can support opioid use disorder (OUD) prevention and treatment efforts via measurement, structured transition of care summaries and other steps suggested in the proposed rule. Opioid measures are a priority for NCQA. The HEDIS® measure suite now includes:
- Use of Opioids at High Dosage.
- Use of Opioids from Multiple Providers.
- Initiation and Engagement of Alcohol and Other Drug Abuse or Dependence Treatment.
- Follow-Up After Emergency Department Visit for Alcohol and Other Drug Abuse or Dependence.
We hope to begin using two additional opioid measures in 2020:
- Follow-Up After High-Intensity Care for Substance Use Disorder, to assess whether adolescents and adults with high-intensity treatment for substance use disorder receive a follow-up visit or service.
- Pharmacotherapy for Opioid Use Disorder, to assess new OUD pharmacotherapy episodes that result in 180 or more covered treatment days among adolescents and adults with an OUD diagnosis.
We are exploring several additional opioid measures, including nonopioid chronic pain management, fatal and non-fatal overdose, and hepatitis C and HIV incidence.
As noted above, we believe that USCDI should include fields for data on opioid use and OUD, given the urgent need to better address our nation’s OUD crisis. We also believe the clinical decision support Hooks health IT specification is mature enough to support compliance with the CDC’s opioid guidelines, and we encourage its adoption.
Clinical Quality Measure Reporting: We support the direction proposed for quality measure reporting, but urge you to use HL7 Quality Reporting Document Architecture version 1 (QRDA 1) for clinicians. QRDA 1 has more granular data and is better for streamlined reporting of HEDIS and other clinical quality measures. We do not believe FHIR-enabled APIs are sufficiently mature or used widely enough to replace or complement QRDA reports for quality reporting and improvement.
More important, we are deeply concerned that current ONC certification and CMS reporting requirements are not rigorous enough to ensure that electronically reported clinical quality measure (eCQM) results are accurate and valid. This is a serious problem, given that in value-based payment systems, measurement results now redirect billions of payment dollars.
Failure to ensure greater accuracy and validity of measurement results could misdirect vast sums of money and severely undermine confidence in the nationwide movement toward paying for value rather than volume.
NCQA requires annual recertification for HEDIS to ensure that systems are properly updated for code-set changes. These changes can be challenging for the industry, and the move to Clinical Quality Language—and eventually, to FHIR—will add to the challenge by completely changing many measure definitions.
It is therefore imperative that ONC and CMS require all algorithms in eCQM reporting modules to be fully tested. We urge you to mandate that certified systems undergo annual measure certification.
We also strongly urge ONC to require transmission of test data in CCD rather than the current process that only tests ingestion of QRDA files. Using QRDAs as the interoperability standard to reproduce QRDAs merely tests format reporting. It does not test a system’s capability to sift through simulation of patient data with both positive and negative records from a swath of data likely to exist in the real world. Testing with CCDs is needed to ensure algorithmic compliance with measure specifications.
Registries: We believe ONC should set standards to improve bidirectional interoperability with registries. When establishing such standards, it will be essential to ensure that you hold registries to the same standards as everyone else for reporting eCQMs.
Thank you again for the opportunity to comment on the draft. If you have any questions, please contact Paul Cotton, NCQA Director of Federal Affairs, at (202) 955-5162 or at email@example.com.
Margaret E. O’Kane
HEDIS®, the Healthcare Effectiveness Data & Information Set, is a registered trademark of NCQA.