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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 the JIRA Issues Tracking System is open to receive candidate measures from measure developers/stewards. JIRA 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. Candidate measures covered by Section 3014 ordinarily appear 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 the program owners must include a rationale for the use of the measure in the notice.

CMS aligns measures across programs whenever possible, and, when choosing measures for new programs, looks first to measures that are currently in existing programs.  

CMS’s goal is to fill critical gaps in measurement that align with and support the Meaningful Measures Framework  as defined by CMS. CMS programs must balance competing goals of establishing parsimonious sets of measures, while including sufficient measures to facilitate multi-specialty provider participation. 

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Events 2018-2019

  • March 1, 2018: JIRA Opens for all CMS Programs
  • April 3, 2018: MUC Kickoff Webinar
  • April 5, 2018: JIRA Open Forum #1
  • April 10, 2018: CMS Program Measure Needs and Priorities Webinar
  • April 12, 2018: JIRA Open Forum #2
  • June 1, 2018: MIPS-Quality measures due 
  • June 15, 2018: JIRA closes, no more submissions accepted 
  • December 1, 2018: MUC List published
  • December, 2018: Measure Applications Partnership
  • January, 2019: MAP  Coordinating Committee meeting takes place
  • February 1, 2019: MAP recommendations published

Timeline flowchart of the pre-rulemaking process

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Submitting Candidate Measures

Stakeholders can submit candidate quality and efficiency measure specifications for CMS review using JIRA - an issues tracking system. CMS opens JIRA in the second quarter of the fiscal year to receive these measures.

Note: User credentials are required to access the JIRA system.  If you need access to JIRA, refer to the 2018 CMS Measures under Consideration User Guide and Quick Start Guide for JIRA for assistance.

Measure submitters are encouraged to use the JIRA MUC Template Blank to gather required information in advance of entering the measure specifications into JIRA.

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

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Multi-Stakeholder Inputs

As part of the pre-rulemaking process, HHS is required to convene multi-stakeholder groups to provide consensus-based input for the annual Measures under Consideration List.

Measure Applications Partnership (MAP)

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, the National Quality Forum (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

Pre-Rulemaking Cup Diagram

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 for rulemaking via the Federal Register 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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Educational Webinars

Additional Resources

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Contact for More Information

For more information about the Pre-Rulemaking Process, email the Measure Management Support Team at MMSSupport@Battelle.org.

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