IPRCC Meeting - 5/28/2019

Introduction

On May 28, 2019 at 2:30 p.m., a meeting of the Interagency Pain Research Coordinating Committee (IPRCC) convened on the National Institutes of Health (NIH) campus in Bethesda, Maryland and by WebEx Teleconference. In accordance with Public Law 92-463, the meeting was open to the public. Martha Somerman, DDS, PhD, Director of the National Institute of Dental and Craniofacial Research (NIDCR), presided.

The following members of the IPRCC were in attendance:

Federal Members: David Clark, MD, PhD; Charles G. Helmick, II, MD; Sharon Hertz, MD; Martha J. Somerman, DDS, PhD  

Scientific Members: Daniel B. Carr, MD; Robert D. Kerns, PhD; Roger B. Fillingim, PhD

Public Members: George Carter; Janet Chambers; Gwenn Herman

Ex-Officio Members: Helene M. Langevin, MD, CM (Ex-Officio); Ann Cashion, PhD, RN, FAAN

Designated Federal Official: Linda L. Porter, PhD

Call to Order and Welcome, Welcome and Introduction of Committee Members

Dr. Martha Somerman, Director, NIDCR; Federal Member, IPRCC

Dr. Somerman welcomed participants to the meeting and informed everyone that she was presiding in place of Dr. Walter Koroshetz, Director NINDS. Dr. Koroshetz was in a bicycle accident and while recovering well, was unable to attend the call. The next meeting of the IPRCC will be a face to face meeting on the NIH campus in Bethesda, MD in November 2019.

Dr. Somerman stated that the goal of this call is to provide updates on ongoing federal efforts including the NIH HEAL Initiative, the Trans-agency Pain Management Task-Force and the CMS/NIH leadership council.

Dr. Elizabeth Kato was introduced as a new member of the IPRCC. She replaces Richard Ricciardi as the representative for the Agency for Healthcare Research Quality (AHRQ).

Dr. Kato received her Bachelor of Arts in Political Science and Asian Studies and a Masters of Regional Planning from Cornell University. After working in relief and development in Asia, she returned to the United States to complete a medical degree at the University of Maryland. Since then she has pursued an interest in health technology assessment, first as a Senior Medical Research Analyst at Hayes Incorporated, then for the past ten years as a Medical Officer in the Center for Outcomes and Evidence at AHRQ.

IPRCC Membership Update: The makeup of the committee is mandated by the Affordable Care Act which established the IPRCC. We are currently short of new members to maintain the required balance of federal, scientific and public members due to unexpected departures and the length of time required by HHS to approve the slate. Thank you to the following members who have agreed to extend their terms through July 2019 to cover these gaps: Dan Carr, Jan Chambers, Roger Fillingim, Michael Pasternak and Catherine Underwood. 

2019 Slate Status: The new slate has been submitted to fill the membership gaps. We hope to have them on board by November.  The Federal Register Notice was posted earlier this year along with outreach to the pain community to call for nominations for members to serve three-year terms. The nominee’s expertise and experience was carefully reviewed by staff and NIH Pain Consortium Leadership. Along with scientific, clinical and community achievements, geographic distribution and diversity of the committee were considered. The nomination slate is now awaiting approval by the NIH Office of the Director  and the Secretary HHS.

Office of Pain Policy and Planning Reorganization and Introductions

Dr. Linda Porter, Director Office of Pain Policy and Planning, NINDS and Designated Federal Official IPRCC

The Office of Pain Policy and Planning has expanded its duties. Up to a year ago, the OPPP had three primary duties: 1) support of the NIH Pain Consortium including support of activities, organization of  meetings, coordination of initiatives and acting as an outreach platform for the NIH Pain Consortium: 2) support of the IPRCC including logistics support of meetings, leadership of activities, and providing an outreach platform and performing portfolio analyses as needed for the IPRCC: and 3) policy duties including reporting to congress and providing analyses and materials to the NIH leadership.  The OPPP now has two additional duties: 1) support of the Common Fund, Acute to Chronic Pain Signatures program and 2) liaison to the NIH OD and to NIH staff during development and implementation of the HEAL initiative. We hope to work with them in the future on integration of HEAL projects across the NIH as well as tracking and evaluation of the projects.

To support these new responsibilities, the OPPP hired two newanalysts:

Dr. Laura Wandner was hired to work primarily on the Common Fund Project. Dr. Wandner is a clinical psychologist who was working in pain care and pain research, most recently at Walter Reed Medical Center. She has an undergraduate degree from Connecticut College and did her graduate work at University of Florida. She did her internship and Postdoc at New Haven in Connecticut then joined Walter Reed.

Dr. Danielle Haney was hired to work primarily on efforts that fall under the HEAL Initiative. Dr. Haney was an AAAS fellow at NHLBI where she worked on a variety of activities including outreach, communications and portfolio analyses. Dr. Haney has a bachelor’s degree from Xavier University of Louisiana and did both her graduate work and post-doctoral work at the University of Pennsylvania working with T-cell function related to HIV.

HEAL Initiative Update (Clinical & Preclinical)

Dr. Rebecca Baker, Office of the Director, NIH, Director HEAL Initiative

Dr. Linda Porter

Dr. Michael Oshinsky, Program Officer NINDS

Dr. Baker provided an overview of the NIH HEAL initiative which is part of the Department of Health and Human Services’ response to the national opioid crisis. It is a trans-NIH initiative with 26 different projects lead by 12 different NIH institutes and centers with participation by 20 different ICs. The HEAL initiative has two primary goals; improving treatment for opioid misuse and addiction and enhancing pain management. The projects within the HEAL Initiative represent the interplay of the two goals but are broadly categorized into separate groups. The NIH is working with other federal agencies including FDA and CMS, local and state governments and communities to bring scientific solutions to people suffering from opioid use disorder and pain. Over 40 HEAL funding opportunity announcements were released to date, and many awards will be made by the end of the fiscal year on September 30th. The goal is to obligate $850M from FY19 and unspent carry over from FY18.  The OD has been working closely with program staff to develop research programs. These will be reviewed by the HEAL Executive Committee that includes Dr. Francis Collins, Dr. Larry Tabak and the directors of NIH Institutes and Centers that fund pain research. The HEAL Multidisciplinary Working Group (MDWG), composed of outside pain and addiction experts including some past members of the IPRCC, helps the NIH make decisions by looking across the entire initiative to ensure that there are no major gaps in scientific research areas or public health needs in the areas of pain and addiction. The MDWG has met twice, and the information from those meetings can be found on the NIH HEAL website.

Discussion:

Challenges surrounding the release of the HEAL Initiative funding announcements were discussed. The NIH was concerned by the sparsity of grant submissions to some programs and the investigators expressed frustration at the short time window to respond to the solicitations. Some funding announcements were re-released to solicit additional applications.  It was stated that because the HEAL money will be part of the NIH’s budget base, there will be continued support for ongoing projects and opportunities to fund new programs. It also was stated that the clinical research community response was quite good. The community has risen to the challenge, and NIH would like to say thank you. As we move forward, it is hoped that the pace will be more leisurely as we determine how much money will be available for new projects.

Dr. Linda Porter

Dr. Porter provided an update of the status of the NIH HEAL Clinical studies related to pain management.

The NIH HEAL Initiative will be establishing several pain research networks including:

• Back Pain Consortium (BACPAC)
  • Will support a range of studies including; mechanisms, technology development, and clinical trials to understand and treat low back pain.
  • Applications have been received and will be reviewed for consideration for September Council.

• Comparative Effectiveness Pain Management Network (ERN)
  • Will support effectiveness trials across a range of pain conditions, using the established NIH Trial Innovations infrastructure.
  • The applications have been received will be reviewed for consideration at September Council.

• Pragmatic and Implementation Studies for the Management of Pain (PRISM)
  • Will support implementation and dissemination studies of effective pain management strategies embedded in large health care systems.
  • The applications have been received and will be reviewed for consideration at September Council.

• Integrated Approach to Pain and Opioid Use in Hemodialysis Patients
  • Will support trials to evaluate effectiveness of non-pharmacological approaches to improve pain care and reduce reliance on opioids during hemodialysis.
  • Applications are in and will be reviewed for consideration at September council.

• NCI National Community Oncology Research Program (NCORP)
  • Will support one clinical trial to improve pain management in a cohort of cancer patients who suffer with chronic pain related to cancer or cancer treatment.
  • Applications have been received and will be reviewed for consideration at September council.

• The NICHD Maternal Fetal Medicine Unit (MFMU)
  • Will support one clinical trial to improve pain care for women with peripartum pain.
  • Applications have been received and will be reviewed for consideration at September council.

• Early Phase Clinical Trials Network (EPPIC Net)
  • Applications for the network infrastructure were received and will be reviewed for consideration at May and September Councils.
  • Applications for assets and for clinical trials to submit to the network for evaluation in specific pain cohorts will be received and reviewed on a rolling basis when the network is established.

Other Clinical Pain Research Programs of the HEAL Initiative include:

• Discovery of Biomarkers, Biomarker Signatures and Endpoints for Pain
  • Will includes clinical trials and mechanistic studies to discover and validate a broad range of pain biomarkers.
• Small Business Program (SBIR/STTR)
  • Will support translational and clinical studies to develop devices to treat pain
  • Applications have been received through the SBIR solicitations and targeted HEAL solicitations. The applications received for this program cover a broad range of pain conditions.

Dr. Michael Oshinsky, Program Officer NINDS

Dr. Oshinsky provided an update of the status of the NIH HEAL Preclinical studies related to pain management.

The HEAL Pre-clinical pain research program has the following goals:

Discovery and validation of novel targets for safe and effective pain treatment.
Acceleration of discovery and development of non-addictive treatments for pain.
Engineering preclinical screening platforms to promote novel drug development.
Translating discoveries into effective devices for pain treatment.
Identifying biomarkers, signatures and endpoints for pain.

Target Discovery and Validation for Safe and Effective Pain Treatment

• The goal of this program is to promote the basic science discovery and validation of targets for the treatment of pain that can be used to develop treatments that have minimal side effects and little to no abuse/addiction liability.
• Administrative supplements were approved by the May council after discussion in the MDWG to add validation studies to ongoing target-discovery projects.
• The RO1 and R21announcements are focused specifically on validation. There has been a tremendous response to date, and the RFA is still open, with two more receipt dates.

Optimization of Non-addictive Therapies (Small Molecules and Biologics) to Treat Pain

• The goal of this program is to accelerate the optimization and development of promising small molecule and biological hits/leads into therapeutic agents.
• The response was not as strong as expected, and program staff added a receipt date to encourage submission of more applications.

Preclinical Screening Platform (PSPP)

• The goal of this program is to establish a site with experience with pain models and to provide a tiered structure where compounds move efficiently through the platform to expedite development of assets for pain management.
• The proposed contracts for these sites have been received. The goal is to have the program up and running by the early fall 2019.          

Translating Discoveries into Effective Devices for Pain Treatment

• We recognize the importance of devices to treat pain conditions. Both the BRAIN and SPARC initiatives have roles to play in contributing to HEAL initiative to optimize devices to treat pain. Applications to develop and optimize devices that will target modulation of peripheral and central nervous system pain circuitry will be supported through HEAL within these programs. 

Biomarkers, Endpoints and Signatures for Pain Conditions

• The goal is to develop and validate independent measures of pain intensity and quality that do not rely on patient reports. 
• These are phased mechanisms where the first phase is used to get data to meet milestones to move to the second phase where measures are used in humans. 

There is a diversity of targets and therapeutics that are being targeted by the applications.

Discussion.

A question was asked about data repositories that were discussed early in the development of the HEAL initiative. It was explained that the clinical trial networks will have data-coordinating centers that will help with data integration. The data from their centers will be managed and stored in a Central HEAL Data Repository. The NIH staff has been developing Common Data Elements to be sure that the data coming in from all the trials is as harmonized as possible. A data sharing plan is also under development.  

Interagency Pain Management Task Force

Dr. Vanila Singh, Chief Medical Officer, Office of the Assistant Secretary for Health, Chair, Pain Management Best Practices Task Force

Dr. Singh provided the committee with an update on the CARA Pain Management Best Practices Interagency task force. The final report will be provided on May 30th to congress. The task force report is a culmination of three public meetings with input from key stakeholders. The report includes five treatment pillars of; Medication, Restorative Therapies, Interventional Procedures, Behavioral Health Approaches, and Complementary and Integrative Health. They are combined with the four cross-cutting elements of risk assessment, stigma, access to care and education. The report also addresses the importance of individualized patient care including a diagnostic evaluation and multidisciplinary treatment plan. The draft report received a huge volume of feedback during the public comment period which will be integrated into the final report.   

Discussion:

The next steps were discussed. A dissemination plan was required as a part of the CARA legislation. All concerned stakeholders can begin to implement recommendations immediately after the final report is released. The hope is that Congress will support the recommendations of the report.                          

A2CPS Common Fund Program Update

Dr. Laura Wandner, Office of Pain Policy and Planning, NINDS

Dr. Wandner presented an update of the Common Fund Acute to Chronic Pain Signatures (A2CPS) program. The goal of the program is to establish a means to identify which patients are likely to be susceptible versus resilient to the transition from acute to chronic pain.  Since the last IPRCC meeting, five FOAs were released. Applications underwent peer review in February 2019, programmatic review in February and council review in May 2019. We expect that awards will be made in July 2019 and the planning year will begin in 2019. 

An A2CPS kickoff meeting will occur in September 2019. Attendees will include awardees, external program consultants and biomarker experts. The goal is to identify 40 biomarkers that may help predict acute to chronic pain transition and/or resiliency that will be assessed throughout the duration of the program.

There is a request for Information (RFI) that closes June 1, 2019. NIH is seeking input from the scientific community on potential high value markers for outcome measures. 
                                                    

CMS-NIH Leadership Council Update

Dr. Linda Porter, Dr. Wendy Weber, NCCIH, and Dr. Laura Wandner

The NIH-CMS working group is led by Wilson Compton, Deputy Director of NIDA and Shari Ling, Deputy Chief Medical Officer, CMS. It supports goals of the NIH-CMS Leadership Council for the agencies to work together to improve coverage for addiction and overdose treatments and for pain management.

The following working groups were developed to support the objectives of the Council:

•    Consider common clinical outcomes for opioid use disorder
•    Develop emergency department strategies for overdose
•    Explore evidence for non-pharmacological treatments for pain 
•    Develop care/payment models for opioid use disorder

Dr. Laura Wandner updated the committee on the CMS-NIH Subcommittee on Non-Pharmacological Pain Management to examine the evidence for non-pharmacological pain treatments. Their goal is to identify opportunities for NIH, in partnership with CMS, to support research to determine the effectiveness for treatments for older adults and people with disabilities who have chronic pain. The research studies will be designed to provide an evidence base necessary for Medicare fee-for-services coverage consideration.

Dr. Weber presented the first priority research study to be co-sponsored by CMS and NIH. They will support a pragmatic randomized controlled trial of acupuncture for management of chronic low back pain in older adults. In January, 2019, CMS opened the Medicare National Coverage Analysis (NCA) to complete a review of the evidence to determine if acupuncture for chronic Low Back Pain is reasonable and necessary under the Medicare program. Coverage determinations look at whether evidence is sufficient to conclude that the technology improves clinically meaningful health outcomes for the Medicare population. The process for determining coverage informed the development of the NIH-CMS study. An RFA has been released.  This program is supported by the NIH Health Care Systems Research Collaboratory Program which is co-chaired by Dr. Helene Langevin, Director of the National Center for Complementary and Integrative Health (NCCIH) and Dr. Richard Hodes, Director of the National Institute on Aging (NIA). The program established a coordinating center to provide leadership and technical expertise on conducting research within large health care delivery systems. Information about the collaboratory can be found at Rethinking Clinical Trials.

Dr. Weber described the Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults. The awards are phased and the first year of planning will allow the study to align with CMS policies. Applicants were required to partner with at least two healthcare systems for a large-scale pragmatic trial in which the study is embedded into the healthcare delivery system.

Discussion:

It was noted that there are many different types of acupuncture. The investigator will be proposing the type of acupuncture and provide justification for it to be used in the study.

It also was noted that CMS buy-in is required to select the study topics and designs. It is expected that the process will accelerate over time, by studying treatment packages rather than individual modalities for coverage, or by focusing on modalities that are covered for other health conditions which may then be more easily approved for coverage for pain management without a full pragmatic trial. CMS is a federally supported entity and their coverage determinations are set through regulatory processes and guidelines. Changing the coverage regulations requires data for their specific coverage population. 
 

CMS-NIH Subcommittee on Non-Pharmacological Pain Management Updates

Dr. Wander presented a summary of a literature search of non-pharmacological evidence-based modalities to identify highest priorities for funding future studies. The Non-pharmacological Modalities of Pain Managment table (pdf, 285 kb) was discussed and IPRCC member feedback was incorporated. 

IPRP Portfolio Analysis Plan

Dr. Leah Pogorzala, Office of Pain Policy and Planning, NINDS

Dr. Pogorzala informed the committee that the Interagency Pain Research Portfolio Database is up to date through 2016. The OPPP is performing a portfolio analysis of the database as it aligns to the HEAL initiative. This will serve as a baseline for the office to track and monitor HEAL progress. The committee was asked for input.

Discussion:

It was recommended that OPPP looks at research science advances and studies being performed by other federal partners to determine whether there is anything missing from the analysis.

It was also discussed that the complexity of pain conditions makes a portfolio analysis very difficult because some research is classified by

The need for community outreach and advertising of the HEAL Initiative was highlighted. The Office of Evaluation Performance and reporting is a newly formed office at the NIH. They have begun to monitor best practices for monitoring HEAL in addition to outreach and advertisement.

NIH Pain Consortium Symposium Overview

Dr. Cheryse Sankar, Office of Pain Policy and Planning, NINDS

Dr. Sankar presented an overview of the NIH Pain Consortium Symposium on May 30-31, 2019. The Pain Consortium Symposium organizing committee and Executive Committee select a theme that represents current advances in pain research and state of the field. The co-organizers of the symposium this year are Dr. Yolanda V from NIDCR and Dr. Martha Matocha from NINR. The theme is Advances in Pain Research: Pain Across the Lifespan. The Keynote speakers Sr. Angus Deaton, PhD and Anne Case, PhD will be presenting an economists perspective of the opioid epidemic.

Approval of the Minutes of the November 16, 2018, IPRCC Meeting

Dr. Linda Porter

The IPRCC approved the November 16, 2018, meeting minutes, with no corrections.

IPRCC Member Updates

Mr. George Carter noted two local news articles in the Richmond Times Dispatch for Monday May13, 2019 and Tuesday, May 14, 2019, about a patient who was suffering from pain from an automobile accident and noted that he was having difficulty obtaining treatment because of prescribing practice changes in response to the CDC guidelines. He hopes that the NIH can play a role in helping patients who are having difficulty receiving opioid medications. 

With no further comments, the meeting was adjourned at 5:00pm. 

No public comments were submitted. The meeting was adjourned.

We certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

Linda Porter, PhD
Designated Federal Official
Interagency Pain Research Coordinating Committee
Director, Office of Pain Policy, National Institute of Neurological Disorders and Stroke
 
Walter Koroshetz, PhD
Chair Interagency Pain Research Coordinating Committee
Director, National Institute of Neurological Disorders and Stroke
 
These minutes have been formally approved by the committee.