June 17, 2022
Centers for Medicare & Medicaid Services
Department of Health & Human Services
Hubert H. Humphrey Building
200 Independence Ave., S.W.
Washington, DC 20201
Dear Administrator Brooks-LaSure:
The National Committee for Quality Assurance (NCQA) thanks you for the opportunity to comment on the FY 2023 Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System Proposed Rule.
NCQA is a private, 501(c)(3) not-for-profit, independent organization dedicated to improving health care quality through our Accreditation and measurement programs. We are a national leader in quality oversight and a pioneer in digital quality measurement. Leveraging our strengths as a trusted third party, we are committed to helping organizations navigate the challenges associated with transitioning to a digital future. Our mission to improve the quality of health for all Americans, with an intentional focus on health equity and support for meaningful value-based payment models, propels our daily work.
NCQA is pleased to provide comments on the proposals and considerations outlined in the proposed rule.
Continuing to Advance to Digital Quality Measurement and the Use of Fast Healthcare Interoperability Resources (FHIR) in Hospital Quality Programs—Request for Information
Refined Definition of Digital Quality Measures (dQM)
NCQA supports CMS’s proposed update to the definition of dQMs as “quality measures organized as self-contained measure specifications and code packages, that use one or more sources of health information that is captured and can be transmitted electronically via interoperable systems.” As stated in our response to the FY 2022 IPPS/LTCH PPS proposed rule, we believe the definition should include the potential for dQMs to be developed in a way that allows their components to support a variety of use cases, such as decision support and quality improvement.
We also concur with CMS that eCQMs meet the definition of “dQM,” but, as CMS notes, “limitations in data standards, requirements, and technology have limited their interoperability.” We believe these limitations, and challenges aggregating QRDA files, have constrained their adoption in value-based contracts—one reason why we are working to deliver the next generation of dQMs as configurable, modular software applications that can integrate relevant data via FHIR and other standard-based APIs.
Toward that end, on June 1, NCQA launched our inaugural Digital Quality Solutions Pilot, a software development project in coordination with six trailblazing health plans, delivery systems and health IT firms. These organizations will provide vital feedback on the usefulness, feasibility and value of NCQA software and next-generation measure prototypes intended to align quality measurement across health care, and prove the value of an end-to-end measure calculation solution (or measure calculation tool [MCT]) by distributing digital measures from an MCT to end users. This pioneering work can move the industry forward to realizing the full potential of dQMs and can be a prototype for CMS’s considerations for MCTs, as outlined in its recently published Digital Quality Measurement Strategic Roadmap.
Data Standardization Activities to Leverage and Advance Standards for Digital Data
Enabling a Learning Health System (LHS) through data standardization: dQMs are a critical component of a fully interoperable LHS that generates reliable knowledge when it is needed most. In our opinion, this is not accurately depicted in CMS’s latest LHS model. We request that CMS give additional consideration to how dQMs fit into an LHS.
dQMs should not be a standalone “use case” for digital data in the LHS, but can serve a critical role in the aggregation and processing that organizes information into knowledge. The current model CMS put forward describes dQMs as they would occur in the traditional retrospective reporting cycle, and fails to unlock their full potential to support use cases beyond reporting. We welcome the opportunity to share our vision for including dQMs in the knowledge domain, since they are not only calculation tools, but a key industry standard for translating evidence-based practice guidelines into actionable clinical utility.
And while we support, and are encouraged by, the promise of FHIR, CMS’s digital strategy should not focus solely on moving all stakeholders to FHIR standards—an essential step—but should also enable migration to a set of standards and support mapping among standards. FHIR standards do not yet support all data models used by the measurement and research communities, so it may be premature to force conformance to a single model. Mapping among a variety of data models can accelerate progress, providing the most value and easing the burden of transitioning to digital measurement. We believe CMS should put resources toward efforts to advance data interoperability, and focus on making tooling and guidance freely available, to enable uptake. Collaborations like OMOP on FHIR, where the community developed tools to convert from one data model to another, is an example of advancing data standards but not requiring a “one-size fits all” approach at this stage of the digital journey.
Implementation Guides (IG): We believe the IGs referenced are valuable to operationalize the current state of quality measurement (e.g., eCQMs), but are not yet adequate to operationalize future dQMs. NCQA is prepared to expend considerable resources to lead IG development and to ensure that the quality measurement use case is considered. We commend HL7 and the DaVinci Project for their enormous contributions to date.
We appreciate CMS’s consideration of additional IGs needed to support the future state of all dQMs, such as “guidance on aggregation mechanisms for reporting.” We encourage CMS to consider IGs in two categories, each with unique contributions to an all-dQM future: content/context IGs (e.g., measures expressed in FHIR-CQL) and operational IGs (e.g., for data aggregation or CMS reporting). It is essential that throughout this transition we describe digital specifications (content/context) and digital reporting (operational) as two distinct concepts supporting a single goal.
USCDI: We are encouraged by the collaboration of federal agencies to define data classes and elements needed for digital quality measurement and public reporting through USCDI+. But although this idea is novel for circumventing the limitations of burdening USCDI, we urge CMS and ONC to release additional details for stakeholder input. Plans, vendors, systems and providers are adopting solutions to meet both federal and commercial needs. USCDI+ should not be limited only to meeting “federal agency data needs.”
Furthermore, USCDI and USCDI+ will not be solely sufficient for measurement purposes. While both activities are commendable for defining standardized data elements and classes, the level of detail is inadequate to ensure validity or reliability. The role of aggregation will be critical to normalize, standardize and provide quality controls to ensure that digital data have been extracted, transformed and loaded from a clinical data source through appropriate and valid methods. We thank CMS for noting the importance of providing guidance and processes to ensure appropriate aggregation in the CMS Digital Quality Measurement Strategic Roadmap, and for highlighting NCQA’s Data Aggregator Validation program as an avenue to ensure that data transmitted by aggregators are complete, accurate, reliable and standardized.
Approaches to Achieving FHIR eCQM Reporting
NCQA continues to strongly support the proposed transition from the Quality Data Model to the FHIR standard for all CMS quality measure reporting, including eCQM reporting. We have already created
22 FHIR-CQL digital HEDIS measures, and we intend to advance our digital measures portfolio by converting existing HEDIS measures to digital specifications and creating de novo dQMs.
We continue to evolve our HEDIS portfolio and HEDIS Audit and Certification methodology, with the goal of optimizing data flow and providing a seamless infrastructure to align measurement principles across the American health care system. Our Digital Solutions Pilot, mentioned earlier, will help us define the data model that enables connected measures across the levels of health care and provides timely information to clinicians, health systems, plans and governments to support quality improvement.
Advancing the Trusted Exchange Framework (TEFCA) and Common Agreement (CA)—Request for Information
We applaud CMS’s interest in advancing the TEFCA and CA within the Medicare Promoting Interoperability Program, and we agree that hospitals should get credit for the Health Information Exchange objective by signing a “Framework Agreement” as defined in the CA. We encourage CMS to continue to incentivize standardized data exchange under TEFCA through other CMS programs and value-based payment models. This will greatly enhance our ability to automatically extract data for quality measurement from HIEs and other non-EMR clinical data sources.
Overarching Principles for Measuring Healthcare Quality Disparities Across CMS Quality Programs—Request for Information
We commend CMS’s commitment to measuring health equity across its programs, and we encourage CMS to consider these overarching principles across quality programs:
- Alignment: Align, where possible and appropriate.
- Meaningfulness: Balance additional measure burden with strong evidence or justification.
- Advance equity beyond disparities: Integrate factors beyond differences in subgroups.
- Utility: Link health equity measurement to broader payment and policy goals.
- Innovation: Remain open to non-traditional quality measure concepts that leverage new or under-used data sources.
- Acknowledge limitations: Be honest about what quality measures can and cannot achieve.
Additionally, we recommend CMS take the following policy actions:
- Align and stratify quality measures with valid collection principles for race, ethnicity, language, disability and social risk factors.
- Define a unified approach to social determinants of health measurement.
- Integrate person-centered measurement, informed by historically underrepresented communities.
- Incorporate and assess adoption of Culturally and Linguistically Appropriate Services (CLAS) Standards across contracted entities.
Align Quality Measures With Valid Collection Principles for Race, Ethnicity, Language, Disability and Social Risk Factors
We applaud the Center for Medicare for publicly reporting stratified HEDIS rates for Medicare Advantage for well over a decade. CMS should expand this work to other quality and payment programs. We would welcome the opportunity to work with CMS to adjust and align quality measures as we continue to evolve our measure portfolio. We are committed to stratifying our HEDIS measure set to shine a light on disparities across American health care while maintaining the integrity and validity stakeholders expect from HEDIS.
We encourage CMS and other federal stakeholders to consider policy levers to increase collection of race, ethnicity and other demographic data, and we recently published recommendations with Grantmakers in Health, Federal Action Is Needed to Improve Race and Ethnicity Data in Health Programs.
We believe CMS should use its authority under Section 4302 of the Affordable Care Act to require Medicare, Medicare Advantage and Medicaid payments to be tied to specific performance levels for reporting race, ethnicity and language data, beginning with two existing HEDIS measures: Race/Ethnicity Diversity of Membership and Language Diversity of Membership. However, we also believe CMS should compel reporting of complete data on race, ethnicity, gender identity and sexual orientation, people with disability and marginalized populations.
Define a Unified Approach to Social Determinants of Health Measurement
We are encouraged by the CMS proposals to measure and promote health equity in 2023 quality programs. We agree that patient-level, health-related social needs data are essential to encourage meaningful collaboration between health care payers, providers and community-based organizations, and that measures in this space should be mandatory by CY 2024, as proposed in the Hospital IQR program.
NCQA supports performance measures that evaluate assessment of health-related social needs at the patient level and in a clinical setting, and we agree with CMS’s position to not require use of a specific assessment tool—a position consistent with the work of the Gravity Project. NCQA supports aligning measures with the Gravity Project’s work to standardize interoperable social needs data, and we encourage CMS to do the same.
NCQA is developing a measure (for MY 2023) that assesses screening for unmet food, housing and transportation needs, and referral to intervention after a positive screen. Domains in the measure are based on maturity of electronic data standards, and the measure can expand to additional domains as data standards advance. Because social needs data can be captured in a variety of electronic data sources (e.g., EMRs, resource referral platforms, case management systems), NCQA’s measure is specified for electronic reporting through Electronic Clinical Data System (ECDS) reporting, aligns with the Gravity Project’s standards and will be subject to the traditional HEDIS audit, to ensure validity of results. We welcome the opportunity to work with CMS to ensure that measures of social needs are reliable, valid and ease the burden of collection.
We encourage CMS to align the Screening for Social Drivers of Health and Screen Positive Rate for Social Drivers of Health measures with the Gravity Project’s efforts before making the measures mandatory. Currently they do not align with the Gravity Project’s timeline for harmonizing social risk factor data for interoperable electronic exchange, or account for screening outcomes.
Integrate Person-Centered Measurement, Informed by Historically Underrepresented Communities
We are at a nascent stage for measuring health equity, and we must ensure that the voice of the person and family caregiver is consistently represented as this science advances. It is essential that CMS leverage stakeholders from marginalized communities and those with lived experience in creating a national strategy for health equity measurement. To date, state Medicaid agencies have led the way in defining best practices and involving diverse voices in constructing quality oversight programs. With input from state Medicaid programs, NCQA recently released a white paper, Evaluating Medicaid’s Use of Quality Measurement to Achieve Equity Goals, which includes a section on stakeholder and community engagement. Our findings can provide CMS with insight and considerations for engaging diverse stakeholders in the measurement process.
We encourage CMS to adopt principles of person-driven outcome measures to help achieve equitable outcomes while striving to ensure that next-generation person-reported outcome measures are designed around the concept of what matters most to patients and their family caregivers. NCQA’s person-driven, patient-centered outcome measures (under development) integrate, drive and assess care that matters across the care continuum. NCQA is preparing for a measure testing learning collaborative that will help further develop and finalize the measures for widespread dissemination, which we hope includes eventual use in federal programs.
Incorporate and Assess Adoption of CLAS Standards Across Contracted Entities
We share the Biden-Harris Administration’s commitment to health equity, and we encourage organizations to place standards and measures at the center of their commitment to transparency and accountability for equitable health outcomes. We hear daily from quality teams at health systems and health plans about the importance of Accreditation and performance measures for building organizational commitment to reducing health disparities in the populations they serve.
Even though in 2000 the federal government published CLAS Standards as guidance for providing health care to linguistically diverse communities, it has not funded implementation of CLAS, and without an enforcement mechanism, CLAS uptake has been limited. We encourage CMS to change this, and were pleased to see, in the CMS Health Equity Strategy, that Administrator Brooks-LaSure charged each CMS Center and Office with promoting CLAS and building health equity into core work.
In 2010 NCQA released Multicultural Healthcare (MHC) Distinction, the first national program to align with CLAS standards and help health care organizations (e.g., hospitals, health systems, health plans) put structures in place to collect race, ethnicity and language data, with the goal of understanding and taking steps to eradicate health disparities in their populations. In 2020 we added standards for diversity, equity, inclusion and collecting sexual orientation and gender identity data, and relaunched MHC Distinction as Health Equity Accreditation. We have been encouraged by the interest and value health systems and hospitals see in this Accreditation program.
In November 2021, with assistance from nine leading health organizations across the country, we launched a pilot program to develop Health Equity Accreditation Plus. This program helps health care organizations establish processes and cross-sector partnerships that identify and address social risk factors and social needs of the people in their communities. NCQA is working with pilot participants to test the concepts and application of this new program. Their feedback will help us enhance and streamline its standards. Health Equity Accreditation Plus will be available to health plans, health systems and other care organizations this month.
Thank you again for the opportunity to comment. We welcome the chance to discuss our experience and findings, and we remain committed to working with CMS to build a more equitable, sustainable and responsible American health care system. If you have any questions, please contact Eric Musser, NCQA Assistant Vice President of Federal Affairs, at (202) 955-3590 or at email@example.com.
Margaret E. O’Kane