Pre-Rulemaking

Pre-Rulemaking

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Overview

Section 3014 of the Affordable Care Act of 2010 (ACA) (P.L. 111-148) created a new section 1890A of the Social Security Act (the Act), which requires that the U.S. Department of Health and Human Services (HHS) establish a federal pre-rulemaking process for the selection of quality and efficiency measures for use by HHS. The categories of measures are described in section 1890(b)(7)(B) of the Act. 

The pre­-rulemaking process includes the following steps:

  1. Each year CMS invites the submission of candidate measures from measure developers/stewards. The submission period closes on a prescribed date to allow HHS time to review and make their selection of measures to place on the Measures Under Consideration (MUC) List;
  2. Annually, no later than December 1, HHS makes publicly available a list of quality and efficiency measures that HHS is considering adopting, through the federal rulemaking process, for use in Medicare program(s);
  3. Multi-stakeholder groups provide recommendations to HHS no later than February 1 annually on the quality and efficiency measures under consideration;
  4. HHS considers the multi-stakeholder groups’ input in selecting quality and efficiency measures;
  5. Measures selected by HHS are proposed in a notice of proposed rulemaking in the Federal Register, which allows for public comment and further consideration before a final rule is issued. If a candidate measure is not yet endorsed by the consensus-based entity with a contract under Section 1890 of the Act (currently the National Quality Forum [NQF]), then a rationale for the use of the measure must be included in the notice.

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2022 Guidance for Measure Submitters

The Centers for Medicare & Medicaid Services (CMS) Measures Under Consideration Entry/Review Information Tool (CMS MERIT) is the tool for measure developers to submit their clinical quality measures for consideration by CMS. This tool allows you to enter and submit the required information for your submission, with the ability to save your information and return to edit it prior to submission. The deadline for new measure submission is May 20, 2022 at 8:00 PM ET.  Please read below for additional information and send any questions to us at MMSsupport@battelle.org.

Measure Priorities  

CMS’s goal is to fill critical gaps in measurement that align with and support the Meaningful Measures Framework, which identifies high priority areas for quality measurement. Its purpose is to improve outcomes for patients, their families and providers while also reducing burden and moving payment toward value through focusing everyone’s efforts on the same quality areas. The Meaningful Measures Initiative also helps to identify and close important measure gap areas, align measures across the continuum of care and across payers, and spur innovation in patient-reported measures, digital measures, and new measure types.

As a public call for measures, the pre-rulemaking process helps to ensure that the quality measures in CMS programs are patient-centered and meaningful to patients, clinicians, and providers, and promote CMS’s quality goals. Patient-reported outcome measures (PROMs) and other measures using patient-generated data are needed and highly prioritized in CMS programs. For additional information about CMS priorities, see the 2022 MUC List Program-Specific Measure Needs and Priorities (PDF) for all programs involved in the pre-rulemaking process and the CMS Quality Measure Development Plan for the Merit-based Incentive Payment System (MIPS).

Quality programs must balance competing goals of establishing parsimonious sets of measures, while including sufficient measures to facilitate multi-specialty provider participation. CMS aligns measures across programs whenever possible, and, when choosing measures for new programs, looks first to measures that are currently in existing programs. For more information about measures currently in CMS programs, explore the CMS Measures Inventory Tool.

Also, CMS has developed the Quality Measure Index (QMI), an internal tool, to systematically assess the relative value of quality measures in achieving CMS strategic objectives. The QMI is intended to provide a repeatable and consistent assessment of measures and enhance the decision-making processes currently used by CMS for measure selection, implementation, and continued use in quality reporting programs.  Modifications or additions have been made to requested measure information submitted during the candidate measure submission process to standardize and determine the availability of the information required for the QMI.

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Events 2022-2023

This image shows a list of events to be held between January 2021 and February 2022.

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Submitting Candidate Measures

For the 2022 submission period, stakeholders can submit candidate quality and efficiency measure specifications for CMS review by completing the required fields in the CMS MUC Entry/Review Information Tool (CMS MERIT).  Please refer to the MUC List template (DOCX) for an outline of the data fields required for submission and the CMS MERIT Submitter’s Quick Start Guide (PDF) to provide guidance on using the tool. The submission period opens on January 28, 2022 and will close for submissions on May 20, 2022 at 8:00 PM ET.

Candidate measures for the Merit-based Incentive Payment System (MIPS) are required to have a completed peer-reviewed journal article template (DOCX) attached to the measure record in CMS MERIT. Examples of completed templates are also linked below for your reference.

All measures submitted to CMS should be fully specified and tested for reliability and validity (PDF). For additional information, use the Measures Management System website and the CMS Measures Management System Blueprint (PDF) for guidance.

We encourage you to return often to the website to see new information regarding the 2022 MUC submission cycle.

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Measure Applications Partnership (MAP)

As part of the pre-rulemaking process multi-stakeholder groups are convened by NQF to provide consensus-based input for the annual Measures under Consideration List.

The MAP is a multi-stakeholder partnership that provides recommendations to HHS on the selection of quality and efficiency measures for CMS programs. First launched in the spring of 2011, NQF is currently under contract with HHS to convene and facilitate the MAP workgroups. The MAP’s overall goal is to maintain transparency and encourage public engagement throughout this process. All MAP meetings are open to the public, and meeting summaries are posted on the NQF website. 

Providing Input on the MUC List:

  • After receiving the annual MUC List, the MAP workgroups and Coordinating Committee convene to fulfill their statutory requirement of providing input to HHS on Measures Under Consideration for use in Medicare programs. 
  • The workgroups evaluate the candidate measures using the Measure Selection Criteria developed by the MAP. One of several conclusions will be reached for each candidate measure: support, do not support, conditionally support, or refine and resubmit. 
  • The MAP provides program-specific recommendations to HHS no later than February 1.
  • HHS takes MAP’s analysis and advice into account, but HHS alone makes the final decisions about measure selection and implementation in public programs.  If HHS decides to take a candidate measure that MAP did not support, and propose it through the Federal rulemaking process, CMS will provide a rationale for that decision.

MAP Reports

Below are links to MAP reports for 2011 forward:

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Previous Measures Under Consideration Lists

Information on measures under consideration in previous years is accessible through CMS MERIT; additionally, links to previous Measures Under Consideration Lists for 2011 and forward are below. Note that these are historical documents, and may contain information (such as contact information) that is no longer current.

Additional Resources

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Contact for More Information

For more information about the pre-rulemaking process, inquiries about measures submitted for the 2022 cycle, or questions on other general measure topics, please email MMSsupport@battelle.org.

 

Page Last Modified:
09/06/2023 04:57 PM
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