MEDCAC Meeting

Analysis of Coverage with Evidence Development (CED) Criteria

02/13/2023

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Issue

On December 7, 2022 February 13 and 14, 2023 the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC panel will examine the requirements for clinical studies submitted for CMS coverage under Coverage with Evidence Development (CED). It has been nearly eight years since the criteria for CED were last evaluated and codified. In that time, not only have technologies become more complex, but there has been growing appreciation and commitment to transparency in decision-making, to making certain that study methodologies are “fit to purpose” as determined by the topic, questions asked, health outcomes studied, and to making certain that the populations studied are representative of the diversity in the Medicare beneficiary population. For example, some questions may be sufficiently answered through analysis of real-world evidence including data from clinical registries, electronic health records, and administrative claims. Any decision about whether an item or service is reasonable and necessary must, minimally, be sensitive to these commitments as well as to ensuring that study participants’ interests are respected and protected. The MEDCAC will evaluate the CED criteria to assure that CED studies are evaluated with consistent, feasible, transparent and methodologically rigorous criteria and advise CMS on whether the criteria are appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary.

Actions Taken

September 12, 2022

CMS announces MEDCAC meeting.

October 7, 2022

Posted Federal Register Notice

November 10, 2022

November 17, 2022

CMS will reschedule the December 7, 2022 Coverage with Evidence Development (CED) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) virtual meeting and extend the meeting from one to two-days, February 13 and 14, 2023, 10am-3pm EST. CMS is rescheduling and extending the meeting to two days because of public comments asking for more time to prepare and respond to the recommended CED revisions and public comments asking for more clarity of the meeting.

CMS will publish the MEDCAC voting questions no later than December 31, 2022, to ensure that the public has time to fully prepare. Further, CMS will re-open the registration to allow for additional speakers, presentations and comments. Those that already submitted comments or presentations or requested to speak at the December 7, 2022 meeting, continue to have a reserved time slot and do not need to re-register but you will have to register to attend.

We note that this MEDCAC is to discuss and make recommendations to CMS regarding the CED criteria. The MEDCAC panel will use the final AHRQ report (as a basis of its discussion during the MEDCAC meeting. The meetings purpose is neither to discuss technologies, such as devices, drugs or biologics, nor to discuss the CMS’s use of the CED pathway whereby Medicare covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data

December 7, 2022

Posted updated FR notice.

December 23, 2022

Posted panel roster and questions to panel.

January 30, 2023

February 14, 2023

Posted Jodi Segal's presentation from February 13.

February 23, 2023

Posted scoresheet and recordings from meeting.

April 11, 2023

Posted transcripts from meeting.


  • Registration
  • Agenda

    Agenda
    Medicare Evidence Development & Coverage Advisory Committee
    February 13, 2023
    10:00 AM – 3:00 PM
    Virtual Meeting

    Joseph Ross, MD, MHS, Committee Chair
    Sanket Dhruva, MD, MHS, Committee Vice-Chair
    Tamara Syrek Jensen, Director, Coverage and Analysis Group
    Tara Hall, MEDCAC Coordinator

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    10:00 – 10:15 AM

    Opening Remarks – Tara Hall/Tamara Syrek Jensen/Joseph Ross, MD, MHS

    10:15 - 10:45 AM

    TA Presentation- Jodi Segal, MD, MPH-Professor of Medicine, Epidemiology, and Health Policy and Management John Hopkins

    10:45 – 11:15 AM

    Questions from Panel

    11:15 – 11:30 AM

    Break

    11:30 – 12:50 PM

    Scheduled Public Comments

    ************************************************************************************

    Public attendees, who have contacted the MEDCAC Coordinator prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors.

    Speakers
    • Cybil Roehrenbeck, JD, Hogan Lovells
    • Diana Zuckerman, National Center for Health Research
    • Donnette Smith
    • Jay Reinstein, Voices of Alzheimer’s
    • M Kay Scanlan, JD, Haystack Project
    • Susan Peschin, MHS, Alliance for Aging Research
    • Tara Burke, PhD, AdvaMed
    • Yajuan Lu, Boston Scientific
    • William Padula, PhD, Leonard D. Schaeffer Center for Health Policy & Economics
    Speakers with Presentations
    • Beena Bhuiyan Khan, Duke-Robert J. Margolis, MD, Center for Health Policy
    • Brian Carey, Foley Hoag LLP
    • Cathy Cutler, PhD, Brookhaven National Laboratory
    • Lindsay Bockstedt, Medtronic, Inc.
    • Ralph G. Brindis, MD, MPH, MACC, American College of Cardiology

    12:50 – 1:20 PM

    Lunch

    1:20 – 1:40 PM

    Open Public Comments
    Public Attendees who wish to address the panel will be given that opportunity
    Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors.

    1:40 – 3:00 PM

    Questions to Presenters

    3:00 PM - Adjourn for the day




    Agenda
    Medicare Evidence Development & Coverage Advisory Committee
    February 14, 2023
    10:00 AM – 3:00 PM
    Virtual Meeting

    Joseph Ross, MD, MHS, Committee Chair
    Sanket Dhruva, MD, MHS, Committee Vice-Chair
    Tamara Syrek Jensen, Director, Coverage and Analysis Group
    Tara Hall, MEDCAC Coordinator

    ———————————————————————————————————————————————————————————————

    10:00 – 10:15 AM

    Opening Remarks/Recap – Tara Hall/Tamara Syrek Jensen/Joseph Ross, MD, MHS

    10:15 – 11:15 AM

    Initial Open Panel Discussion: Dr. Ross

    11:15 – 12:15 PM

    Formal Remarks and Voting Questions
    The Chairperson will ask each panel member to state his or her position on the voting questions.

    12:15 – 12:45 AM

    Lunch

    12:45 – 1:45 PM

    Formal Remarks and Voting Questions
    The Chairperson will ask each panel member to state his or her position on the voting questions.

    1:45 – 2:30 PM

    Final Open Panel Discussion: Dr. Ross

    2:30 – 3:00 PM

    Closing Remarks/Adjournment: Tamara Syrek Jensen and Dr. Ross

    Minutes

    Transcripts

    VOLUME I (February 13, 2023, day one of two)
    VOLUME II (February 14, 2023, day two of two)

    Panel Voting Questions

    Download scoresheet

    COVERAGE WITH EVIDENCE DEVELOPMENT PROPOSED REVISED REQUIREMENTS
    MEDCAC PANEL QUESTIONS

    BACKGROUND: On February 13 and 14, 2023 the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC panel will examine and discuss the revisions of the requirements for clinical studies submitted for CMS coverage under Coverage with Evidence Development (CED) recommended by the Agency for Healthcare Research and Quality’s (AHRQ’s) Evidence-based Practice Program. It has been nearly eight years since the CED requirements were last evaluated.  In that time, not only have technologies become more complex, but there has been growing appreciation and commitment to transparency in decision-making, to making certain that study methodologies are “fit to purpose” as determined by the topic, and to making certain that the populations studied are representative of the diversity in the Medicare beneficiary population.  The MEDCAC will evaluate the proposed revisions to the CED requirements to ensure that CED studies are evaluated with consistent, feasible, transparent and methodologically rigorous requirements. The MEDCAC will also advise CMS on whether the proposed revisions to the requirements are appropriate to ensure that CED-approved studies will produce evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary.

    Note: The meeting’s purpose is not to discuss specific services or technologies, such as devices, drugs or biologics or when it may be appropriate to issue a CED National Coverage Determination.


    For each voting question, please use the following scale identifying the level of importance for each requirement – a score of 0 being not important, a score of 1 point being important, and a score of 2 points being essential.

    Please score each of the following proposed Requirements as:
    0
    Not Important
    1
    Important
    2
    Essential

    SPONSOR
         1) Current CED Requirements (version 2014) (e) The study is sponsored by an organization or individual capable of completing it successfully,

    • The study is conducted by sponsors/investigators with the resources and skills to complete it successfully

    COMMUNICATION
         2) No existing Requirement,

    • A written plan describes the schedule for completion of key study milestones to ensure timely completion of the CED process.

    GOVERANCE
         3)      No existing Requirement,     

    • The protocol describes the information governance and data security provisions that have been established.

    CONTEXT
         4) Current CED Requirements (version 2014) (b) and (c) (b)The rationale for the study is well   supported by available scientific and medical evidence. (c) The study results are not anticipated to unjustifiably duplicate existing knowledge.

    • The rationale for the study is supported by scientific evidence and study results are expected to fill the specified knowledge gap and provide evidence of net benefit.

         5) Current CED Requirements (version 2014) (a) The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.

    • Sponsors/investigators establish an evidentiary threshold for the primary outcome(s) so as to demonstrate clinically meaningful differences with sufficient precision.

    OUTCOMES
         6) No Existing Requirement,

    • The primary outcome(s) for the study are clinically meaningful and important to patients. A surrogate outcome that reliably predicts these outcomes may be appropriate for some questions.

    PROTOCOL
         7) Current CED Requirements (version 2014) (h) and (j), (h) The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements; and (j) The clinical research studies and registries are registered on the www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient Registries (RoPR).

    • The CED study is registered with ClinicalTrials.gov and a complete protocol is delivered to CMS.

    POPULATION
         8) No existing Requirement,

    • The study population reflects the demographic and clinical diversity among the Medicare beneficiaries who are the intended users of the intervention. This includes attention to the intended users’ racial and ethnic backgrounds, gender, and socio-economic status, at a minimum.

    GENERALIZABLE
         9) Current CED Requirements (version 2014) (m) The study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

    • When feasible and appropriate for answering the CED question, data for the study should come from beneficiaries in their usual sites of care, although randomization to receive the product may be in place.

    DATA QUALITY
         10) No existing Requirement,

    • The data are generated or selected with attention to completeness, accuracy, sufficiency of duration of observation to demonstrate durability of results, and sufficiency of sample size as required by the question.

    DATA USE
         11) No existing Requirement,

    • Sponsors/investigators provide information about the validity of the primary exposure and outcome measures, including when using primary data that is collected for the study and when using existing (secondary) data.

    DESIGN
         12) Current CED Requirements (version 2014) (d) and (g), (d) The study design is methodologically appropriate, and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination. (g) All aspects of the study are conducted according to appropriate standards of scientific integrity.

    • The study design is selected to generate valid evidence safely and efficiently for decision making by CMS. If a contemporaneous comparison group is not included, this choice must be justified.
    • The sponsors/investigators minimize the impact of confounding and biases on inferences with rigorous design and appropriate statistical techniques.

    DESIGN-SUBPOPULATIONS
         13) Current CED Requirements (version 2014) (l) The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion Requirements effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trail. If the inclusion and exclusion Requirements are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these Requirements are necessary.

    • In the protocol, the sponsors/investigators describe plans for analyzing demographic subpopulations, defined by gender and age, as well as clinically- relevant subgroups as motivated by existing evidence. Description of plans for exploratory analyses, as relevant subgroups emerge, is also appropriate to include, but not required.

    REPRODUCIBILITY
         14) No existing Requirements,

    • Sponsors/investigators using secondary data will demonstrate robustness of results by conducting alternative analyses and/or using supplementary data.

    REPORTING
         15) Current CED Requirements (version 2014) (k) The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early.  The results must be made public within 12 months of the study’s primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer-reviewed scientific journal (in print or on-line), in an on-line publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).

    • The study is submitted for peer review with the goal of publication using a reporting guideline appropriate for the study design and structured to enable replication.

    SHARING
         16) No existing Requirements,

    • The sponsors/investigators commit to sharing analytical output, methods, and analytic code with CMS or with a trusted third party in accordance with the rules of additional funders, institutional review boards, and data vendors as applicable. The schedule for sharing is included among the study milestones. The study should comply with all applicable laws regarding subject privacy, including section 165.514 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA)

    LEGAL
         17) Current CED Requirements (version 2014) (i), The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.

    • The study is not designed to exclusively test toxicity, although it is acceptable for a study to test a reduction in toxicity of a product relative to standard of care or an appropriate comparator. For studies that involve researching the safety and effectiveness of new drugs and biological products aimed at treating life-threatening or severely-debilitating diseases, refer to additional requirements set forth in 21 CFR §312.81(a).

    Contact Information

    Other Material

    Roster

    Committee Chair:

    Joseph Ross, MD, MHS
    Professor
    Medicine and Public Health
    Section of General Internal Medicine
    Department of Medicine
    Yale University School of Medicine

    Committee Vice Chair:

    Sanket Dhruva, MD, MHS, FACC
    Assistant Professor of Medicine
    UCSF School of Medicine
    Affiliate Faculty, Philip R. Lee Institute for Health Policy Studies
    Staff Physician (Cardiology),
    San Francisco VA Medical Center

    MEDCAC Members:

    Michael J. Fisch, MD, MPH, FACP, FAAHPM
    Clinical Professor, MD Anderson Cancer Center
    National Medical Director
    AIM Specialty Health
    Clinical Trials

    David Flannery, MD
    Staff and Director of Telegenetics and Digital Genetics, Center for Personalized Genetic Healthcare Genomic Medicine Institute
    Cleveland Clinic
    Genetics

    Carolyn Ford, PharmD
    Professor and Director of Community Healthcare Outreach
    Wingate University School of Pharmacy
    Health Disparities

    Genevieve Kanter, PhD
    Associate Professor
    Sol Price School of Public Policy
    Schaeffer Center for Health Policy and Economics
    University of Southern California

    Karen Joynt Maddox, MD, MPH, FACC, FAHA
    Assistant Professor, Washington University School of Medicine
    Co-Director, Center for Health Economics and Policy, Institute for Public Health at Washington University School of Medicine
    Cardiology

    Marc Mora, MD
    Senior Medical Director
    Networks and Care Management
    Kaiser Permanente Washington
    Evidence based medicine

    Olorunseun O. Ogunwobi, MD, PhD
    Director, Hunter College Center for Cancer Health Disparities Research (CCHDR)
    Associate Professor of Biology
    Department of Biological Sciences
    Hunter College of the City University of NY
    and Adjunct Assistant Professor
    Joan and Sanford I. Weill Department of Medicine
    Weill Cornell Medical College
    Oncology

    Sally Stearns, PhD
    Professor, Department of Health Policy and Management
    Gillings School of Global Public Health
    The University of North Carolina at Chapel Hill
    Public Health

    John Whitney, MD
    Vice President, Medical Policy
    Anthem, Inc.
    Internal Medicine

    Dru Riddle, PhD, DNP, CRNA
    Associate Professor of Professional Practice
    Texas Christian University
    Genetics

    Ian N. Kremer, JD
    Executive Director
    Leaders Engaged on Alzheimer's Disease

    Industry Representatives

    Parashar Patel, MA
    President & CEO
    Market Access Strategy, LLC

    Guest Panel Members

    Daniel Arthur Caños, PhD, MPH
    Director, Office of Clinical Evidence and Analysis
    Office of Product Evaluation and Quality
    CDRH| Food and Drug Administration

    Craig A. Umscheid, MD, MS
    Director, Evidence-based Practice Center Division
    Senior Science Advisor, Center for Evidence and Practice Improvement
    Agency for Healthcare Research and Quality

    Richard J. Hodes, M.D.
    Director
    National Institute on Aging
    National Institutes of Health

    Speaker list

    Medicare Evidence Development & Coverage Advisory Committee
    February 13, 2023

    SPEAKER LIST


    *5 MINUTES PER SPEAKER*

  • Cybil Roehrenbeck, JD, Hogan Lovells

  • Diana Zuckerman, National Center for Health Research

  • Donnette Smith

  • Jay Reinstein, Voices of Alzheimer’s

  • M Kay Scanlan, JD, Haystack Project

  • Susan Peschin, MHS, Alliance for Aging Research

  • Tara Burke, PhD, AdvaMed

  • Yajuan Lu, Boston Scientific

  • William Padula, PhD, Leonard D. Schaeffer Center for Health Policy & Economics

    Presentations:

  • Beena Bhuiyan Khan, Duke-Robert J. Margolis, MD, Center for Health Policy

  • Brian Carey, Foley Hoag LLP

  • Cathy Cutler, PhD, Brookhaven National Laboratory

  • Lindsay Bockstedt, Medtronic, Inc.

  • Ralph G. Brindis, MD, MPH, MACC, American College of Cardiology

  • Associated NCA

    Associated Technology Assessment