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###### Department of Health and Human Services

          - [CMS-3340-N]

# AGENCY: 

Office of the Secretary of Health and Human Services, HHS.

# ACTION:

Notice.

# SUMMARY: 

                        This notice acknowledges that in accordance with section 1890(b)(5)(B) of the Social Security Act (the Act) the Secretary of the Department of Health and Human Services (the Secretary) has received and reviewed the National Quality Forum (NQF) Report of 2016 Activities to Congress and the Secretary of the Department of Health and Human Services submitted by the consensus-based entity with whom the Secretary has a contract under section 1890(a) of the Act. The purpose of this                         **Federal Register**                         notice is to publish the report, together with the Secretary's comments on such report.                    

# FOR FURTHER INFORMATION CONTACT: 

Sophia Chan, (410) 786-5050.

## I. Background

The Secretary of the Department of Health and Human Services (the Secretary) has long recognized that a high functioning health care system that provides higher quality care requires accurate, valid, and reliable measurement of quality and efficiency. Section 1890(a) of the Social Security Act (the Act), as added by section 183(a)(1) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), requires the Secretary to identify and have in effect a contract with a consensus-based entity (CBE) to perform multiple duties described in subsection (b) that are designed to help improve performance measurement. The duties described in subsection (b) originally included a priority setting process, measure endorsement, measure maintenance, electronic health record promotion, and the preparation of an annual Report to Congress and the Secretary. Section 3003(b) of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act (Pub. L. 111-152) (collectively, the Affordable Care Act) expanded the duties of the CBE to require the CBE to review and, as appropriate, endorse the episode grouper developed by the Secretary under the Physician Feedback Program. Section 3014(a)(1) of the Affordable Care Act further expanded the duties to require the CBE to convene multi-stakeholder groups to provide input on the selection of quality and efficiency measures and national priorities for improvement in population health and in the delivery of health care services for consideration under the national strategy, and to transmit such input to the Secretary. Section 3014(a)(2) of the Affordable Care Act expanded the requirements for the annual report that must be submitted under section 1890(b)(5)(A) of the Act.

To meet the requirements of section 1890(a) of the Act, in January of 2009, the Department of Health and Human Services (HHS) awarded a competitive contract to the National Quality Forum (NQF). A second, multi-year contract was awarded to NQF after an open competition in 2012. This contract includes the following duties:

*Priority Setting Process: Formulation of a National Strategy and Priorities for Health Care Performance Measurement.*                         The CBE is required to synthesize evidence and convene key stakeholders to make recommendations on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In doing so, the CBE is to give priority to measures that: (1) Address the health care provided to patients with prevalent, high-cost chronic diseases; (2) have the greatest potential for improving quality, efficiency and patient-centeredness of health care; and (3) may be implemented rapidly due to existing evidence, standards of care, or other reasons. Additionally, the CBE must take into account measures that: (1) May assist consumers and patients in making informed health care decisions; (2) address health disparities across groups and areas; and (3) address the continuum of care a patient receives, including across multiple providers, practitioners and settings.                    

*Endorsement of Measures.*                         The CBE is required to provide for the endorsement of standardized health care performance measures. This process must consider whether measures are evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, responsive to variations in patient characteristics such as health status, language capabilities, race or ethnicity, and income level and consistent across types of health care providers, including hospitals and physicians.                    

*Maintenance of CBE Endorsed Measures.*                         The CBE is required to establish and implement a process to ensure that endorsed measures are updated (or retired if obsolete) as new evidence is developed.                    

*Review and Endorsement of an Episode Grouper Under the Physician Feedback Program.*                         “Episode-based” performance measurement is an approach to better understanding the utilization and costs associated with a certain condition by grouping together all the care related to that condition. “Episode groupers” are software tools that combine data to assess such condition-specific utilization and costs over a defined period of time. The CBE is required to provide for the review, and as appropriate, endorsement of an episode grouper as developed by the Secretary on an expedited basis.                    

*Convening Multi-Stakeholder Groups.*                         The CBE must convene multi-stakeholder groups to provide input on: (1) The selection of certain categories of quality and efficiency measures, from among such measures that have been endorsed by the entity; and such measures that have not been considered for endorsement by such entity but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and (2) national priorities for improvement in population health and in the delivery of health care services for consideration under the national strategy. The CBE provides input on measures for use in certain specific Medicare programs, for use in programs that report performance information to the public, and for use in health care programs that are not included under the Act. The multi-stakeholder groups provide input on quality and efficiency measures for use in certain federal programs including                               ( print page 39798)                            those that address certain Medicare services provided through hospices, hospital inpatient and outpatient facilities, physician offices, cancer hospitals, end stage renal disease (ESRD) facilities, inpatient rehabilitation facilities, long-term care hospitals, psychiatric hospitals, and home health care programs. For Medicaid and the Children's Health Insurance Program (CHIP), the multi-stakeholder groups provide input on measures to be included as part of the Medicaid and CHIP Child and Adult Core Sets.                    

*Transmission of Multi-Stakeholder Input.*                         Not later than February 1 of each year, the CBE is required to transmit to the Secretary the input of multi-stakeholder groups.                    

*Annual Report to Congress and the Secretary.*                         Not later than March 1 of each year, the CBE is required to submit to Congress and the Secretary of HHS an annual report. The report is required to describe the following:                    
      - The implementation of quality and efficiency measurement initiatives and the coordination of such initiatives with quality and efficiency initiatives implemented by other payers;
      - Recommendations on an integrated national strategy and priorities for health care performance measurement;
      - Performance by the CBE on the duties required under its contract with HHS;
      - Gaps in endorsed quality and efficiency measures, including measures that are within priority areas identified by the Secretary under the national strategy established under section 399HH of the Public Health Service Act (National Quality Strategy), and where quality and efficiency measures are unavailable or inadequate to identify or address such gaps;
      - Areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the Secretary under the National Quality Strategy, and where targeted research may address such gaps; and
      - The convening of multi-stakeholder groups to provide input on: (1) the selection of quality and efficiency measures from among such measures that have been endorsed by the CBE and those that have not been considered for endorsement by the CBE but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and (2) national priorities for improvement in population health and the delivery of health care services for consideration under the National Quality Strategy.

                        The statutory requirements for the CBE to annually Report to Congress and the Secretary of HHS also specify that the Secretary must review and publish the CBE's annual report in the                         **Federal Register**                        , together with any comments by the Secretary on the report, not later than 6 months after receiving it.                    

                        This                         **Federal Register**                         notice complies with the statutory requirement for Secretarial review and publication of the CBE's annual report. NQF submitted a report on its 2016 activities to the Secretary on March 1, 2017. Comments of the Secretary on this report are presented below in section II and the actual 2017 Annual Report to Congress is provided as an addendum to this                         **Federal Register**                         notice.                    

## II. Secretarial Comments on the NQF Report of 2016 Activities to Congress and the Secretary of the Department of Health and Human Services

Once again we thank the National Quality Forum (NQF) and the many stakeholders who participate in NQF projects for helping to advance the science and utility of health care quality measurement. As part of its annual recurring work to maintain a strong portfolio of endorsed measures for use across varied providers, settings of care, and health conditions, NQF reports that in 2016 it updated its portfolio of approximately 600 endorsed measures by reviewing and endorsing or re-endorsing 197 measures and removing 87 measures. Endorsed measures facilitate the goals of improving care for highly prevalent conditions, fostering better care and coordination, and making the healthcare system more responsive to patient and family needs. These endorsed measures address a wide range of health care topics relevant to HHS programs, including: Person- and family-centered care; care coordination; palliative and end-of-life care; cardiovascular care; behavioral health; pulmonary/critical care; perinatal care; cancer treatment; patient safety; and cost and resource use.

In addition to adding and re-endorsing new and existing measures, some measures were also removed from the portfolio for a variety of reasons (for example, no longer meeting endorsement criteria; harmonization with other similar measures; retirement by the measures developers; replacement with improved measures; and lack of continued need because providers consistently perform at the highest level on those measures). This continuous refinement of the measures portfolio through the measures maintenance process ensures that quality measures remain aligned with current field practices and health care goals. NQF also reports that in 2016 it continued to support the National Quality Strategy (NQS) by endorsing measures linked to the NQS priorities and convening diverse stakeholder groups to reach consensus on key strategies for performance measurement.

In addition, in 2016 NQF undertook and continued a number of projects to address difficult quality measurement issues and reduce the burden of quality measures for clinicians. An important area that NQF continued to address was the issue of attribution, or the process used to assign accountability for a patient and his or her quality outcomes to a clinician, a group of clinicians, or a facility. HHS agrees that engaging clinicians and clearly communicating the methods and benchmarks used to determine attribution are foundational principles in quality measurement. Having clear methods for attribution helps clinicians understand the information given to them from quality measures, and allows for clinicians to make actionable changes to their clinical practices. When clinicians receive meaningful feedback regarding performance measurement, they can use it to implement best practices. Clear performance data reduce clinicians' burden in deciphering quality measurement information and allows them to focus on how best to improve care. While attribution models may differ, clinician engagement, transparency, and clear, usable data remain fundamental to quality measurement.

                        NQF's work on attribution began in 2015 when NQF convened a multi-stakeholder committee to examine attribution models and recommend principles to guide the selection and implementation of approaches. This work has resulted in a thorough list of potential approaches to validly and reliably attribute performance measurement results to one or more clinicians under different delivery models and to identify models of attribution for potential testing. The committee first convened in December 2015 and performed an environmental scan to identify attribution models currently in use and models that have been proposed but not implemented. The environmental scan identified 171 unique attribution models, 27 of which have been implemented and 144 of which remain proposals only. The models differed across care settings, payment models, and in methodology, but there were also areas of similarity. After reviewing and discussing the scan, the committee defined several guiding principles to inform the development of                               ( print page 39799)                            successful attribution models. In addition, the committee developed an Attribution Model Selection Guide and outlined their findings in a report published in December 2016. See “Attribution—Principles and Approaches”, National Quality Forum, December 2016,                         *https://www.qualityforum.org/​Publications/​2016/​12/​Attribution_​-_​Principles_​and_​Approaches.aspx*.                    

Attribution is just one of many areas in which NQF partners with HHS in enhancing and protecting the health and well-being of all Americans. Quality measurement is essential to a high-functioning healthcare system, as evidenced in many of the targeted projects that NQF is being asked to undertake. HHS greatly appreciates the ability to bring many and diverse stakeholders to the table to help develop the strongest possible approaches to quality measurement as a key component of our healthcare system. We look forward to a continued strong partnership with the National Quality Forum in this ongoing endeavor.

## III. Collection of Information Requirements

                        This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501*et seq.*).                    

## IV. Addendum

                        In this Addendum, we are publishing the                         *NQF Report on 2016 Activities to Congress and the Secretary of the Department of Health and Human Services.*

Dated: August 16, 2017.

Thomas E. Price,

Secretary, Department of Health and Human Services.

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BILLING CODE 4150-28-P

[FR Doc. 2017-17734 Filed 8-21-17; 8:45 am]

 BILLING CODE 4150-28-C