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Monday, December 19, 2016

Introduction – Dr. Walter Koroshetz

Dr. Walter Koroshetz, NIH Pain Consortium Executive Committee Chair, opened the meeting by welcoming everyone. He discussed the need for the consortium to meet more frequently, given the number of pain-related issues that are at the forefront.

Update on Federal Pain Research Strategy (FPRS) – Dr. Linda Porter

Dr. Porter provided an update on the progress of the FPRS.  During the Interagency Pain Research Coordinating Committee (IPRCC) meeting held on 10/31/2016 a full update was given.  The FPRS is a strategic plan being developed under the IPRCC in part to meet its mandate and to fulfill the research component of the National Pain Strategy.  There are five working groups that cover the continuum of pain (From prevention to chronic pain management and disparities).  The working groups have been meeting on a bi-weekly basis and have developed a varying number of research priorities.   The working group co-chairs will meet for a face to face meeting to have in-depth discussions about overlapping research priorities and provide feedback on priorities from other working groups.  The Office of Pain Policy will facilitate a research priority ranking process where working group members will be asked to rate and rank each priority, highlight the most impactful priority, and determine whether the priority is an expansion of existing research or a new area of research.  The final document will be reviewed by the FPRS steering committee.  Based on the current timeline, the IPRCC will receive the draft strategic plan in early 2017.

The strategic plan is not only for NIH, but also for other Federal agencies with pain research interests.  Dr. Porter requested feedback from the group regarding Dr. Koroshetz’ proposal to hold a public meeting on the FPRS around the time of the Annual Pain Consortium Symposium (May 31-June 1, 2017).  The meeting would be held after the strategic plan has been finalized, but would allow for further input and Q&A.  There was broad agreement across the Pain Consortium Executive Committee to hold a meeting with an opportunity for public comments. Additional suggestions included, presentation of current priorities more clearly as research objectives, consideration of an appendix of ‘low’ priorities, representation from the pharmaceutical industry to link research priorities to drug development needs, and relevant feedback from FDA. Members discussed biomarkers of pain and the role they might play in the regulatory process.  

FPRS and NPS Implementation Websites - Dr. Leah Pogorzala

Dr. Pogorzala demonstrated the new FPRS and NPS implementation webpages, which are both housed within the Coordinating Committee IPRCC website.  The website is developed and maintained by the Office of Pain Policy. The FPRS webpages feature an overview of its organizational structure and responsibilities of its committees and working groups.  A roster is included for the FPRS Steering Committee and five working groups.  A tentative timeline is also included to track progress. 

The NPS implementation webpages were developed to track progress of objectives and deliverables of the NPS.  The Office of Pain Policy, in collaboration with the Office of the Assistant Secretary of Health and other federal agencies, is coordinating the implementation plan and tracking/evaluation efforts.  The organizational structure of the implementation team and composition and responsibilities of the teams are featured along with the NPS Objectives & Updates, which describe all NPS objectives and progress towards their completion.  In the future, a sharepoint site will be developed to track progress of objectives more efficiently, and the IPRCC website will be redesigned using a new platform. During discussion of the website, one suggestion was to develop a communication plan for the dissemination of the Federal Pain Research Strategy.

2017 Pain Consortium Symposium – Dr. Michael Oshinsky

The Annual NIH Pain Consortium Symposium will take place on May 31-June 1s, 2017 at the Natcher Auditorium on the NIH Main Campus.  The Symposium planning committee met in November 2016 to propose a theme and topics and for the 2017 Symposium.  Following input from the PC Executive Committee, the theme of “Multidisciplinary Strategies for the Management of Pain” was selected.  The three panel sessions will cover multidisciplinary strategies for the prevention of pain, moving towards multidisciplinary care (models of pain integration) and implementation science for multidisciplinary care (overcoming health barriers).  The same meeting structure of one and a half days will be used and will include a keynote speaker, a junior investigator poster session and a patient advocate speaker.  

A PC Executive Committee member recommended another timely session be included focused on the pharmacology of opioids.  This session could focus on major scientific advances (for example, biased agonism) and attempt to answer important questions:  What do we understand about the opioid pathway, addiction and overdose; and what are the effects of short and long-acting opioids?  Fentanyl was mentioned as an example of a drug that has been linked to irreversible overdoses, and it is unknown what the pharmacology underlying its effects is.  Keeping in mind that it is important to focus on the role of opioids specifically within the context of pain pathways and pain treatment, the session may be geared toward the pharmacology of pain.  

The symposium planning committee will take these suggestions into consideration and solicit a list of potential speakers for the keynote address and panel sessions.  An additional suggestion was to consider getting the FDA’s perspective on the pharmacology of pain session.

Dr. Oshinsky notified the members that an email requesting institute/center contributions to support the PC symposium will be sent out at a later date.

Update on the Centers of Excellence in Pain Education – Dr. Dave Thomas

Dr. Thomas provided an update on the Centers of Excellence in Pain Education (CoEPEs).  He noted that a central issue for pain care is the lack of education on pain.  Whereas, medical doctors receive approximately nine hours of training for pain, veterinarians receive ten times more training.  The initial contract for the CoEPEs program ran into hurdles which caused the program to stop and start again.  A new set of CoEPEs were established and now there are two modules available on the Pain Consortium CoEPEs website: modules on “Edna” and “Beverly”, and one (Peter James) that will be released shortly. There is also a naloxone module that provides education about this drug.

Dr. Thomas discussed the benefits of a coordination center rather than the current in-house content development contractor.  A coordination center would allow for more content (modules) with a better website and module testing and dissemination.   Dr. Novotny, the Deputy Assistant Secretary of Health and Human Services asked Dr. Thomas to serve as a co-chair of the pain education working group of the NPS implementation team which may support goals of the CoEPEs including a central web portal.  

Drs. Thomas and Volkow plan to follow up with the Pain Consortium Executive Committee to request institute/center contributions to resuscitate the coordination center model.  Another option is to reduce contract development costs and use the additional funds for professional services contracts.

Dr. Thomas shared lessons learned including the need to assist CoEPEs in content and module development.  The CoEPEs are being released under ‘soft’ promotion until more modules are completed, and perhaps a coordination center can facilitate dissemination.

Examining Insurance Coverage for Acute & Chronic Back Pain Treatment – A pilot study – Dr. Linda Porter

Dr. Porter presented a pilot study on behalf of Chris Jones from the Office of the Assistant Secretary for Planning and Evaluation (ASPE).  The purpose of presenting the study to the NIH Pain Consortium is to gauge interest in supporting an expanded pilot study. This study was presented in detail at the IPRCC meeting held on 10-31-2016.  To address NPS objectives that call for coverage/reimbursement strategies for multidisciplinary pain care, the study authors examined coverage of various pain treatments for low back pain by three insurance companies. An advisory group was established that included staff from ASPE, Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS) and the NIH.   The study design and goals were to develop methodology to examine benefit coverage documents, determine how coverage parameters for non-opioid pharmacological and non-pharmacological treatments, and determine feasibility of conducting a national-level assessment based on the pilot study. The results demonstrated variation in coverage parameters and revealed that some non-pharmacological interventions with potential utility for back pain, such as Cognitive Behavioral Therapy and biofeedback, were not covered.  Policies such as determinations of medical necessity may be barriers to using these treatments.  Expansion of this project would allow for rigorous assessment of national coverage policies for pharmacologic and non-pharmacologic treatments for back pain and how they might affect the use of non-opioid approaches to chronic pain management.

The proposed project is expected to take 45 weeks to complete and costs would be shared by ASPE.  Dr. Porter commented that if there is interest in supporting the expanded study, further details including the full proposal will be sent out to relevant IC Directors.  

PC members discussed potential outcomes of the expanded study including how to encourage changes to reimbursement/coverage plans based on results and analyzing the effects of coverage on patient outcomes. For example, are there higher numbers of opioid prescriptions for patients whose insurance companies primarily cover opioid medications and not non-opioid treatments?  

Dr. Koroshetz mentioned that NIH funding is based on health outcomes research and, by policy, not on health economics research. He raised a concern that the proposed study may be considered the latter and therefore, not eligible for NIH support.  Dr. Volkow suggested that NIH consideration of co-funding for the expanded study should be based on inclusion of aims that address patient outcomes and provided an example of comparing opioid prescriptions to disability claims.

NIH-DoD-VA Pain Management Collaboratory Funding Initiative – Dr. Eve Reider

Dr. Reider introduced the recently announced initiative. She described the impetus for such an initiative.  Over 2.5 million service members were deployed for Iraq and Afghanistan wars and a high number survive with severe injuries. These veterans may experience severe pain along with a myriad of co-existing problems such as mental health, substance abuse and sleep issues.  According to a study published in 2011, 44% of US military members (after combat deployment) experience chronic pain versus an estimated 26% of the general public.  Fifteen percent of US military members (after combat deployment) reported opioid use in the past month versus an estimated 4% of the general public.

The NIH, DoD, and VA have focused on collaborative initiatives centered around substance abuse, mental health problems and non-pharmacological approaches to pain management.  Recognizing the need to provide better pain management to veterans, with a particular emphasis on non-pharmacological treatments to reduce reliance on opioid medications, a collaborative initiative was developed based on the NIH Health Care Systems (HCS) Collaboratory model, whose mission is to strengthen the national capacity to implement cost-effective large-scale research studies that engage healthcare delivery organizations as research partners.  The NIH-DoD-VA pain management collaboratory includes numerous NIH institutes and centers from the NIH Pain Consortium (NCCIH, NINDS, NIDA, NIAAA, NICHD, NCMRR, ORWH and NINR), the Clinical Rehabilitation Medicine Research Program (CRMRP) & Military Operational Medicine Research Program (MOMRP) from the DoD, and the Health Services Research and Development center at the VA.  The goal of the NIH-DoD-VA collaboratory is to use the NIH HCS Collaboratory model to address military and veteran health care delivery of non-pharmacological approaches to management of pain and other comorbid conditions.  Non-pharmacological approaches will include mindfulness, manual therapies (e.g., massage), neuromodulation, psychological and behavioral interventions, and an integrative approach of more than one intervention.   

A coordinating center will be established and a set of high-impact Demonstration Projects will be developed. Outcome measures will include primary outcomes (pain and pain reduction, ability to function in daily life, quality of life, and medication usage/reduction/discontinuation) and secondary outcomes (assessing comorbid conditions in this population). The data, tools, best practices, and resources from the Collaboratory will be made available to health care delivery systems to provide care to military personnel, veterans, and their families. View funding announcements on the Pain Consortium website