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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2020 Guidance for Measure Submitters

As the Centers for Medicare & Medicaid Services (CMS) continues to respond to the 2019 Novel Coronavirus (COVID-19) pandemic, we want to reduce burden where possible so that clinicians and their staff, vendors, and other partners can focus on what’s important, caring for patients. In light of this and to permit measure developers sufficient time to prepare candidate measure information for submission, the deadline for new measure submission is extended to Tuesday, June 30, 2020. CMS will post guidance to assist measure developers in preparing their 2020 measure information for submission.  Please read below for additional information and send any questions to us at prerulemaking@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 gap areas of measures, align measures across the continuum of care and across payers, and to spur innovation in new types of measures such as patient reported measures and electronic measures.

As a public call for measures, the pre-rulemaking process supports CMS’ added focus and specificity and helps to ensure quality measures that are patient centered and meaningful to patients, clinicians, and providers are in CMS programs. Patient reported outcome measures (PROMs) and measures using patient-generated data are needed and highly prioritized in CMS programs. For additional information about CMS priorities, see the 2020 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 program, explore the CMS Measures Inventory Tool.

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Events 2020-2021

 

This image shows a list of events to be held between January 2020 and February 2021.

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Submitting Candidate Measures

The customary ONC Jira platform will not be used for 2020 measure submissions. For the 2020 submission period, stakeholders can submit candidate quality and efficiency measure specifications for CMS review by completing the blank measure template (DOCX) and emailing it to prerulemaking@battelle.org. Please refer to the guidance within the template and the Pre-Rulemaking Transition document (PDF). The submission period opened on January 22 and will close for submissions on June 30.   

If complete test data are not available by June 30, or if new data are collected thereafter, measure owners are asked to submit those data to the same e-mail address no later than Friday, September 4, 2020. Due to the challenging time we are faced with during this 2020 pre-rulemaking cycle, CMS is offering the September 4 extension to enable measure developers to provide any new testing-related supporting data and to update any testing-dependent measure specifications for new 2020 candidate measures that were submitted prior to June 30. If you anticipate requiring the additional time to submit test data after June 30, please submit a request by emailing us at prerulemaking@battelle.org.

Candidate measures for the Merit-based Incentive Payment System (MIPS) are required to have a completed peer-reviewed journal article template (DOCX)  and accompanying the measure information in your e-mail. Examples of completed templates are also provided below for your reference.

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

CMS will be converting to a new web-based interface for measure submission that will be implemented for the MUC 2021 submission cycle. The 2021 measure submission and review workflow process will be similar, but users will have a user-friendly and intuitive tool for submitting candidate measures. We encourage you to return often to the website to see new information regarding the upcoming 2021 MUC submission changes and to learn about ways you can participate in future MUC submission cycles.

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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 and previous Measures under Consideration Lists for 2011 forward:

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Additional Resources

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Contact for More Information

For more information about the Pre-Rulemaking Process, or if you are inquiring about or commenting on measures submitted for the 2020 cycle, please email Prerulemaking@Battelle.org. For questions on other general measure topics, email the Measure Management Support Team at MMSSupport@Battelle.org.

 

Page Last Modified:
05/26/2020 04:29 PM