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Pre-Rule Making

Overview of Rulemaking Process for Measure Selection

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

The pre­ rulemaking process includes the following steps:

  1. Annually, no later than December 1st, DHHS makes publicly available, a list of quality and efficiency measures DHHS is considering adopting, through the federal rulemaking process, for use in Medicare program(s);
  2. Multi-stakeholder groups provide input to DHHS no later than February 1st annually on the selection of quality and efficiency measures;
  3. DHHS considers the multi-stakeholder groups’ input in selecting quality and efficiency measures;
  4. Program owners publish in the Federal Register the rationale for the use of any quality and efficiency measures that are not endorsed by the consensus based entity with a contract under Section 1890 of the Act, which is currently the National Quality Forum (NQF); and
  5. Assess the quality and efficiency impact of the use of endorsed measures and make that assessment available to the public at least every three years.

For more information, view:

Making the List of Measures under Consideration Publically Available

To comply with the law, as a first step, DHHS must annually issue a Measures under Consideration List.

Each year around the second quarter, CMS begins the annual pre-rule making cycle of collecting and compiling quality and efficiency measures for the Measures under Consideration List using an issue tracking system. CMS may also submit ad hoc Measures under Consideration Lists that would be in addition to the regular annual pre-rule making cycle. 

CMS seeks to be inclusive with respect to new measures on this List by:

  • Convening meetings to obtain input and consensus on this List from across DHHS; and
  •  Inviting non-Federal stakeholders to submit proposed quality and efficiency measures at the beginning of each pre-rule making cycle.

CMS will continue aligning measures across programs whenever possible, including establishing “core” measure sets, and, when choosing measures for new programs, looking first to measures that are currently in existing programs.  

CMS’ goal is to fill critical gaps in measurement that align with and support the CMS Quality Strategy and the National Quality Strategy. CMS programs must balance competing goals of establishing parsimonious sets of measures, while including sufficient measures to facilitate multi-specialty provider participation.

See the Measures under Consideration List for 2016. An EXCEL spreadsheet of the list is also available.

Fulfilling Multi-Stakeholder Group Input Requirements

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

Measure Applications Partnership

The Measure Applications Partnership (MAP) is a multi-stakeholder partnership that guides the DHHS on the selection of performance measures for federal health programs. The MAP launched in the spring of 2011, and is currently under contract with the National Quality Forum (NQF) to oversee this work.  The MAP’s overall goal is to maintain transparency for the public and encourage public engagement throughout the work. All MAP meetings are open to the public and meeting summaries are posted on the NQF website. MAP will continue to seek public comment on all input to DHHS. 

Providing Input on the Measures under Consideration List:

  • After receiving the annual Measures under Consideration List no later than December 1, the MAP workgroups and Coordinating Committee convene to fulfill its statutory requirement of providing input to DHHS on Measures under Consideration for use in Medicare programs. 
  • The workgroups evaluate the proposed measures using the Measure Selection Criteria developed by the MAP. One of the three conclusions will be reached for each of the potential measures: support the measure, do not support the measure, or conditionally support the measure. 
  • The MAP provides program-specific recommendations to DHHS no later than February 1.

DHHS is required to take MAP’s analysis and advice into account, but the final decisions about measure selection and implementation in public programs are solely in DHHS’ authority.  If DHHS decides to implement a proposed non-supported measure for rule-making via the Federal Register process, a rationale for that decision will be provided by CMS.

MAP Reports

Below are links to MAP reports and previous Measures under Consideration Lists for 2011 to 2015:

The JIRA System

Stakeholders can input quality and efficiency measure specifications for CMS review using JIRA - an issues tracking system. Note: User credentials are required to access the JIRA system.  If you need access to JIRA, refer to the 2017 CMS Measures under Consideration User Guide for JIRA for assistance.

Educational Webinars on Pre-Rule Making Process  

CMS hosts a series of meetings to kick off the annual Measures under Consideration cycle and refresh pre-rule making stakeholders on the following topics: the statute, CMS’ quality strategy, highlights of the prior year’s lessons learned, JIRA system enhancements, pre-rule making federal program specific needs and priorities, and an introduction of the current cycle’s milestone and future meeting dates.

CMS does not intend for the meeting topics to be repetitive, and the meetings are mainly for Federal DHHS agencies, organizations contracted with these Federal agencies, and healthcare advocacy groups.

Below are descriptions of recent 2016 webinars and links to view the presentations on YouTube:

  • April 5, 2016: 2016 Measures Under Consideration Kick Off – Reviewed the pre-rule making statute, CMS’ quality strategy, substantive versus non-substantive changes, legislative impacts (i.e., Medicare Access & CHIP Reauthorization Act of 2015 (MACRA) and the Merit-based Incentive Payment System (MIPS)), 2015 lessons learned, and a live demonstration of JIRA including what’s new for 2016, modify candidate measure issue type, and more.  The session closed with a live Q & A. 
  • April 7, 2016: 2016 JIRA Open Forum – Pre-rule making review, MIPS Journal Article Requirement, and a live demonstration of JIRA including what’s new for 2016 and reporting features.  The session closed with a live Q & A. 
  • April 12, 2016: 2016 Program Measurement Needs and Priorities Session – CMS program / measure leads discussed CMS’ program specific measure needs and priorities for the 2016 pre-rule making cycle’s Measures under Consideration (MUC) List.  With each annual MUC season, the goal is to align these needs and priorities with candidate measure submissions in JIRA.    
  • April 14, 2016: 2016 JIRA Open Forum Discussion – Pre-rule making review, MIPS Journal Article Requirement, and a live demonstration of JIRA including an issue type review and closing with a Q & A session.     

For a complete timeline of pre-rule making activities, including previous and upcoming webinars, see the 2017-2018 Pre-Rule Making Timeline.

Guidelines for Proposing Measures

The final annually published Measures under Consideration List identify quality and efficiency Measures under Consideration by the Secretary of DHHS for potential use in Medicare program(s).  These programs are defined in the statute.

Several important points to consider and highlight:

  • If CMS chooses not to adopt a measure under the Measures under Consideration List for the current rule-making cycle, the measure remains under consideration by the Secretary and may be proposed and adopted in subsequent rulemaking cycles; 
  • Existing measures that are proposed for expansion into different CMS programs should be submitted on subsequent Measures under Consideration Lists;
  • Some measures are part of a mandatory reporting program.  However, a number of measures, if adopted, would be part of an optional reporting program.  Under this type of program, providers or suppliers may choose whether to participate;
  • The annual Measures under Consideration List includes measures that CMS is currently considering for Medicare program(s).  Inclusion of a measure on the List does not require CMS to adopt the measure for the identified program.  All measures included on the annual pre-rule making List are subject to CMS’ rule-making process;
  • In an effort to provide a more meaningful List, CMS will only include measures that have reached a level of maturity, which allows for meaningful review and are beyond conceptual;  
  • Proposed measure submissions will be accepted if the measure was previously proposed to be on a prior year's published Measures under Consideration List, but was not accepted by any CMS program(s); and
  • Measure specifications may change over time, if a measure has significantly changed, the changed measure must be submitted for each applicable program on a subsequent Measures under Consideration List.

Educational Webinars

Additional Resources