Pain Management Best Practices Inter-Agency Task Force May 31, 2018 Meeting Summary – Day 2

Welcome: 9:00 a.m. – 9:10 a.m.

Ms. Alicia Richmond Scott, MSW, Designated Federal Officer (DFO), took Roll Call and welcomed the Pain Management Best Practices Inter-Agency Task Force (Task Force) Members.

Dr. Vanila Singh, MD, Task Force Chair, provided a recap of themes and discussion points from Day 1.

Opening Remarks: 9:10 a.m. – 9:20 a.m.

Dr. Vanila Singh, MD, Task Force Chair,recapped and highlighted the key topics from Day 1’s discussion:

• Opioid epidemic – the role of fentanyl and heroin in overdose deaths;
• Insurance – payments, service, delivery; the role of CMS in financial reimbursement for alternative non-opioid treatment options;
• 2016 CDC guidelines;
• Patient-centered approach to care;
• Stigma;
• Access to care;
• Pain specialists; lack of providers;
• Education for both patients and physicians;
• Multiple multimodal approaches, therapies, and alternatives are needed for pain management
• Minimize unintentional consequences
• Data-driven and evidence-based results

Clinical Topic Discussions: 9:20 a.m. – 12:00 p.m.

Prevention and Treatment

Dr. Rollin Gallagher, MD –

• Stated that prevention and treatment are under the same umbrella; noted the chronification model, which starts from the moment of pain (acute) and transitions into chronic pain.
• Stated that physicians need to identify the correct treatment that synthesizes both personal characteristics of the patient and the logistical realities of the healthcare system.
• Three levels of prevention:
  • Primary prevention: e.g. seatbelts, exercise in preventing obesity and diabetes, health, diet, and whole health measures;
  • Secondary prevention: the starting point in the healthcare system e.g. routine screening and monitoring, risk factors, mindfulness, integrative health.
    • Dr. Gallagher suggested that physicians consider increasing access to group models such as cognitive behavioral therapies (CBTs), fully staff interdisciplinary teams, and address the gaps in access to care and psychological services.
  • Tertiary prevention: reversal of chronification – treatment is needed for when pain re-occurs.
• Gaps exist within the implementation of these three prevention procedures; they also exist within education, particularly with the pain management of primary care patients and patient education.
• Complementary and alternative treatments need credentialing;
• Psychological services are necessary;
• EMRs connectivity needs to be smooth and transparent.

Dr. Daniel Clauw, MD –

• Consider pain management in pediatric patient population;
• Poor sleep can serve as a contributing factor in enhancing patient pain;
• Chronification of person to patient; understanding certain risk factors.

Dr. Mark Rosenberg, DO –

• From the ER department perspective, 17% of patients discharged from the ER leave with a prescription of opioids, which he believes is too high;
• ALTO model 1.0 (alternatives to opioids) – nerve blocks, multimodal, use non-opioids therapies first; ALTO 2.0 – starting medication-assisted treatment (MAT).

Dr. Amanda Brandow, DO –

• Pediatrics are an important patient population;
• Behavioral health access is difficult. 

Dr. Mary Meagher, PhD –

• Once delivered a 5-hour psychological intervention
  • Found that pain, persistence, and opioid use was decreased after administrating this intervention;
  • Biosocial interventions are important.

Dr. Helena Gazelka, MD –

• Education is necessary – patients and providers should understand that pain is normal; we have created a culture of non-pain or pain free.
• Psychological therapy, acupuncture, and massage are generally not accessible to patients because insurance does not cover these treatments.

Dr. Sharon Hertz, MD –

• It is important that the Task Force properly define language in terms of precision throughout this meeting. 

Dr. Vanila Singh, MD, Task Force Chair –

• Noted the progression of pain versus the progression of drug use

Mental Health and Addiction

Dr. Jonathan Fellers, MD –

• Dr. Fellers expressed the importance of a multi-modal approach in healthcare delivery; she also noted that reimbursement is needed to drive some of those services.
• Dr. Fellers stated that there is an overlap with pain, addiction, and mental health; 32% have co-occurring disorders and co-morbid conditions that are developed. Pain is also a risk factor for suicide.
• Patient education and setting expectations are necessary.
• He noted that multimodal care is very challenging to deliver to patients. There is a fear of what will happen if patient takes opioids again.
• Buprenorphine during surgical procedures.
• There are gaps in knowledge with open heart procedures and OUDs
• Ketamine is used in some instances.
• Dr. Fellers believes that prevention and treatment very similar and go together in the clinical setting.
• He noted that MATs are useful, but there are no real guidelines. What is done or what are the procedures for chronic pain patients? 
• Reimbursement – drives delivery.
• “Chronification” model; care needs to start from moment of pain.
• Dr. Fellers noted that there is a problem with a lack of providers. Need incentives to train social workers, psychologists, and others to work collaboratively.
• Need to consider loan forgiveness programs.
• He stated that emotional awareness and expression training is an integrated approach that also works with mental health and addiction.
• The most consistent risk factors are past or present abuse when it comes to opioids. Dr. Fellers stated that there needs to be scanning more for mental health issues. The key comes from better training and education.
• Disseminating information, removing stigma, and educating PCPs are important.
• A lack of utilization of qualified providers exist. There are artificial barriers stopping them from being able to provide access to patients.
• This requires greater checks to further understand patients to ensure that patients are not becoming addicted and can be self-managed.
• Physicians need to ensure that only the right medicine is administered to those in need. Reducing exposure will help minimize addiction and possible teen/child addiction.
• Pediatricians should be made more aware across the board to help protect and improve the care for them.
• Need better data on pain. Without qualitative data, it is difficult to create working solutions.
• Questions proposed by Dr. Fellers: How do we identify risks? How do we manage those risks? How do we go about helping patient pain without making their condition worse?

Dr. Mary Meagher, PhD –

• Dr. Meagher stated that there are poor enforcements of mental health and parity laws.
• She also believes that there are not enough providers and incentives to train more social workers and addiction specialists.
• Mindfulness strategies, emotional awareness, and expression training should be integrated into MATs.
• Risk factors – opioid use in chronic pain patients; individuals who use other substances such as alcohol; benzodiazepines.
• Early screening of psychological risk factors should be considered.

Dr. Molly Rutherford, MD –

• Dr. Rutherford has incorporated innovative methods within her clinic such as psychological approaches, telehealth contract with counselors.
• She stated the importance of re-education patients on opioids.
• There is a need to address the stigma associated around opioids, SUDs, and mental health and addiction.

Dr. Bruce Schoneboom, PhD –

• Lack of utilization of providers such as with nurses, PAs, and nurse practitioners.
• He stated that there are arbitrary barriers and regulatory barriers from federal and state legislation.

Dr. Cecelia Spitznas, PhD –

• Dr. Spitznas noted that there are additional tools such as payment models, PDMPs, urine testing, consent forms to manage risk factors.
• Additionally, there is a CDC Environmental Scan on pain management.
• She also expressed that people that are still getting medicines for pain hold an obligation to keep them to themselves.
• Dr. Spitznas also noted that it is important to understand the point of contact in which youth are exposed to opioids in the first place.

Ms. Cindy Steinberg –

• Ms. Steinberg noted that there need to be better numbers and data for pain and pain management.

Special Populations

Dr. Amanda Brandow, DO –

• Dr. Brandow noted that sickle cell disease (SCD), women’s health, and other special populations need to be considered when determining best practices for opioids.
• SCD almost exclusively affects African Americans in the U.S and about 8 percent carry sickle cell traits. Average age of death with those with sickle cell is around 40 years old. There is an increase in opioid use within those with sickle cell. The transition from acute pain to chronic pain is still being researched.
• The ability to able to understand the several types of pain sickle cell patients are undergoing is necessary for physicians to be able to deliver the correct treatment.
• Dr. Brandow reiterated how access to care is barrier in providing care for her patients.
• She noted that, typically, patients get treated by sub specialists that can treat the issue but have no experience in treating pain. This may be where some of the over prescribing issues occur, which is often due to a lack of education.
• A study was made to look at predictors of depression after the onset of pain. Dr. Brandow found that patients with no risk took about 6 months before the rate of depression increased.

Dr. Daniel Clauw –

• Noted that providers in special populations are good at treating one type of pain but not good at treating other types of pain.

Dr. Rollin Gallagher, MD –

• Expressed how there is no big data for pain and depression.
• Stated how the number of different providers one has seen previously can influence depression and further intensify pain.

Dr. Michael Lynch, MD –

• Noted how physicians typically quantify chronic pain – on a scale of 1-10

Education

Dr. Sharon Hertz, MD –

• Noted some gaps in education regarding pain management: failure to look at product and patient labeling in patient education, drugs have risks and benefits – the public sometimes does not fully understand this; there is a spectrum of effective pain management strategies.
• Expressed the importance of packaging in prescriptions
• Noted that products are not submitted without substantial review from the FDA.
• Reminded the audience that opioids are scheduled substances and can cause respiratory depression.
• Stated that better education is needed across the board – from providers and patients.
• Respiratory depression is a main issue with drug fatalities.
• Noted that non-opioids have demonstrated to be just as effective as their counterparts.
• Expressed how the physicians should be teaching patients more about the medication they are using.
• If a physician cannot diagnose the cause of pain then they should recommend another physician who may be able to.
• Physicians should consider more alternative medicines, potential risks, and side effects when treating patients
• There are times where patients are given medication that does not make sense to the condition. Physicians need to better understand that when it is outside the scope of their focus, they need to refer the right individuals to help.
• Should consider state public health departments when looking at education. Partnering with these organization will help to disseminate said information.

Dr. Jianguo Cheng, MD –

• Noted that there are two types of pain: pathological and psychological. A physician’s number one duty is to be able to differentiate between the two types of pain and correctly diagnosis the pain.

Providers

Dr. Daniel Clauw, MD –

• Stated how low back pain generally has the best guidelines.
• Noted how guidelines can often be ineffective.
• Noted the placebo exceeds the medication – the magnitude of the placebo effect shows that minimal dosage is acceptable.
• Non-physician providers, chiropractors, PTs, dispensaries should be considered throughout the course of care.
• There are scope of practice issues and reimbursement issues when considering multi-modal care.
• SAMHSA has funded development of education resources: one is a series of modules for treating chronic pain and preventing opioid use disorder. Targeted for individuals who treat chronic pain but also covers preventing the transition to addictive behaviors.
• A newer form of provider has been established labeled peer support counselors to help with chronic pain patients.
• There are ECHO programs that have evidence to show change for the better: DOD, UC Davis, and other institutions that reveal substantial improvement.
• Mid-level providers/clinicians need to be credentialed in certain spaces. Each state has different levels of credentialing programs.
• Credentialing should not be made easy but rather covering scope of risk.
• Dr. Rollins Gallagher, MD – noted how some education programs have been shown to change physician behavior; REMS has not been effect in changing behavior; agreed that mid-level providers need credentialing.
• Dr. John Prunskis, MD – emphasized how the source of diagnosis is very important.

Service, Payment, and Delivery

• Often physicians have opted to simply prescribe opioids instead of diagnosing the issue at hand.
• Non-opioid interventions should be emphasized over the opioid choices.
• Dr. John Prunskis, MD suggested that chronic pain be changed to non-acute pain to lessen the fear that said pain will never diminish.
• Dr. Halena Gazelka, MD – noted that the class and dosage of medication that is covered by insurance is often unknown; alternatives can be provided and prescribed but often coverage is unknown; pills are cheap but are only a temporary fix to the problem.
• Current EHR is poorly constructed and requires too much time.
• There are too many roadblocks when considering what insurance covers, often leading to a different plan or prescriptions because of the lack of coverage.
• Access to treatments is a major issue.
• Patients need treatments that are restorative, not temporary.
• It is imperative that we include a variety of options for patients to have access to in term of treatment.
• Understand the patient’s needs: accurately assess and diagnose.
• There is a need to expand provider team.
• Physicians should consider VR for treatment and Apps as ways to help connect better with patients; possibly utilizing augmented reality.
• Universal precautions are necessary for balance and safety.
• Dr. Jianguo Cheng, MD – know the basic needs and assessment; biopsychosocial approaches need to be individually tailored for the patient; physician’s ability and freedom to tailor treatment is important.

Research and Innovation

• Necessary to innovate our education for both providers and patients.
• There is a strong ignorance of pain mechanisms.
• Pain generating mechanisms are largely unknown.
• Dr. Howard Fields – noted that the problem of addressing pain is largely with the ignorance of pain mechanisms.
• Physicians should approach methods with humility.
• There are some clues in pain generating mechanisms: voltage-gated Na+ channels, genes involved in pain; CGRP in the jugular vein; increase in CGRP; mono-clonal antibodies have been found to be somewhat successful.
• Found that certain types of genes led to certain pain problems. The same polymorphism in that gene caused an inability to feel pain.
• CGRP- found that in the jugular vein, people with migraines have increased levels CGRP
• More research with mechanism-targeted research in humans is needed.
• It is important to understand what the pain causing mechanisms are in more common diseases.
• Opioid receptors have been identified.
• Pain research not focused enough on muscular-skeletal aspects.
• Research is not aligned with the major clinical problems.
• Many of the medications employed do not understand the mechanism by which they produce pain relief.
• Fentanyl produces a lot more respiratory depression.
• Greater research needs to be made towards cannabinoids as it gets rescheduled to Schedule 2. 
• FDA recommended a Cannabidiol (CBD) product for childhood epilepsy.
• Reconsideration of regulatory hurdles that are impeding the processes of research is needed.
• Biological area is coming to the pain field. Antibodies may be promising to patients.

Surgeon General’s Remarks

VADM Jerome M. Adams, MD, MPH, Surgeon General of the United States

• The Task Force is charged with an important mission and the administration is excited to expand the conversation.
• There is an opioid and pain fueled epidemic that takes a life every 12.5 minutes.
• There is an inability to treat chronic pain. A better job needs to be done in discovering innovative ways to treat chronic pain. There are a lot of alternatives but they are not being utilized.

Round Table Discussion: 1:30 p.m. – 1:50 p.m.

• Dr. John McGraw, MD – in rural areas, there are more patients to see that often do not receive timely treatment.
• Dr. Molly Rutherford, MD – Kentucky needs to emphasize education not legislation in prescribing; overdose deaths have still increased every year in states that have enacted legislation; has not been effective.
• Dr. Cecelia Spitznas, PhD – a lot of research does not consider payment methods, the information is not apparent to the industry factors, FDA should create guidance; data is lacking concerning pain, existing programs such as CDC Environmental Scan could be used to inform this decision making.
• Dr. Andrea Trescot, MD – buprenorphine in pain; taking off restrictions on buprenorphine; not FDA approved for pain.
• Dr. Howard Fields, MD – seconded the vote on buprenorphine, it’s a kappa antagonist, kappa drives dependence, several companies are considering this to treat anxiety.
• Dr. Harold Tu, MD – minorities in Minnesota – American Indians, sovereign nations may have impediments to this guidance; these populations cannot be forgotten moving forward.

Round Table Discussion: 1:30 p.m. – 1:50 p.m.

• Dr. John McGraw, MD – in rural areas, there are more patients to see that often do not receive timely treatment.
• Dr. Molly Rutherford, MD – Kentucky needs to emphasize education not legislation in prescribing; overdose deaths have still increased every year in states that have enacted legislation; has not been effective.
• Dr. Cecelia Spitznas, PhD – a lot of research does not consider payment methods, the information is not apparent to the industry factors, FDA should create guidance; data is lacking concerning pain, existing programs such as CDC Environmental Scan could be used to inform this decision making.
• Dr. Andrea Trescot, MD – buprenorphine in pain; taking off restrictions on buprenorphine; not FDA approved for pain.
• Dr. Howard Fields, MD – seconded the vote on buprenorphine, it’s a kappa antagonist, kappa drives dependence, several companies are considering this to treat anxiety.
• Dr. Harold Tu, MD – minorities in Minnesota – American Indians, sovereign nations may have impediments to this guidance; these populations cannot be forgotten moving forward.

Public Comment: 1:50 p.m. – 2:20 p.m.

Ms. Richmond Scott, MSW, Task Force DFO, announced the opening of the public comment period. The public was allowed to provide comments in person and by phone for no more than three minutes.  Below is a summary of the comments shared by the public.
Maureen Repmann –

• As a complex disease patient, Ms. Repmann is regularly hospitalized with many health-related issues.  She asks that the medical committee return to a free market with less roadblocks and provide emergency measures for chronic and disease patients.

Kristen Wheeden, American Porphyria Organization –

• Ms. Wheeden experiences huge pain that is incompatible with life.  Opioids is the only safe medication that helps.  There is too much exaggeration of patients being drug addicts when seeking prescriptions from various physicians.

Pain is rare disease that many physicians are ill equipped to diagnosis.
Rebecca Sidden –

• Autoimmune response in the bladder line is causing Ms. Sidden constant pain.  Her treatment includes a responsible use of opioids, steroids, and other approaches.  She tried various alternatives but nothing seemed to manage her pain.  Almost every change to her medications has been caused by various legislations from agencies.

Jayne Flanders –

• Jayne Flanders emphasized that alternative treatments are great but not in every case.  Pain medication is life saving for many individuals.

Michael Kriegel, S.C Kriegel Consulting – 

• Interdisciplinary pain management has a core requirement of constant clinical treatment, clinical teamwork in treatment, which is not seen in multimodal treatment approaches.  He created an inter-disciplinary management organization specifically designed to help chronic pain patients with little to no opioids.  However, reimbursement difficulties caused his facilities to close.  His practice constantly faced barriers in providing the highest quality services for pain management.

Dr. Sanjay Gupta, MD –

• Some patients are seeing issues with prescriptions because doctors will stop providing the prescriptions without much time for patients to taper.

Dr. Collin, American Association of Critical Care Nurses –

• More emphasis is needed on nurse education research and practice.  Various syndromes underlie the bigger issues of chronic pain.  The DEA raids causing issues and the tool box (opioids) need to still be available.

Remarks: 2:20 p.m. – 2:30 p.m.

Dr. Scott Gottlieb, MD, Commissioner, FDA –

• By reducing rates of addiction, FDA can play a bigger role in delineating the education and information to clinicians
• FDA is taking additional steps in placing more guidance on what medication gets dispensed.
• They are looking to limit and dispense pills in smaller quantities.
• Evidence-based guidelines in dispensing; reduce rates of new addiction; interdiction; better treatment; blister packs, limiting dispensing and quantity.
• FDA is looking to develop better treatments for those who have addictions and also develop more granular guidance on circumstances to help providers have better education.

Task Force Discussion

• Dr. Sharon Hertz, MD - Noted that attempts at trying to get a handle on the elements that contribute to bad outcomes for opioid dependence. Noted that DoD has developed best practices that have been effective on pain management and reducing opioid use.
• Dr. Vanila Singh, MD, Task Force Chair – The DoD and VA are special populations which showcase those efforts. The rest of America shows a very different experience.  She also noted that DDPRS also measures a variety of factors that contribute to opioid dependence.
• Dr. John McGraw, MD - Educating doctors is a slow process that needs to be continued to work on.  There are adult stem cell therapies that work.  He also noted that state created legislation has not been affective in curbing the opioid crisis.
• Ms. Cindy Steinberg - Expressed that the data is lacking concerning pain.
• Dr. Andrea Trescot, MD - strongly supported the idea of education prior to DEA licensing.

Subcommittee Presentation: 2:30 p.m. – 3:00 p.m.

Dr. Vanila Singh, MD, Task Force Chair, provided an overview of the subcommittee structure.  Below is a synopsis.

• Charge of the Task Force, structure of the subcommittee, and timeline of the subcommittees were presented to the Task Force.
• Statute requires that report is submitted one year from 5/30/2018.
• Take into consideration all relevant best practices, recommendations and submit to agencies.
• Must respond to all components outlined in CARA mandate.
• Subcommittees will be broken down into three components
  • Medication, Physical Therapy and Surgical and Minimally Invasive Procedures
  • Psychological approaches, Risk Assessment, and Stigma
  • Complementary and Alternative Medicine, Education, and Access to Care

Deliberation and Vote: 3:00 p.m. – 3:30 p.m.

The Task Force discussed and voted on Subcommittee structure.  Answered questions from Task Force members regarding future meetings and logistics, as well as tight deadlines.

Closing: 3:30 p.m.

Dr. Vanila Singh, MD, Task Force Chair provided thank you statements and closing remarks.

Participants

PMTF Members

• Sondra M. Adkinson, PharmD
• Amanda Brandow, DO, MS
• Commander René Campos, MBA
• Jianguo Cheng, MD, PhD
• Daniel Clauw, MD
• Steve Daviss, MD
• Jonathan C. Fellers, MD
• Howard L. Fields, MD, PhD
• Rollin M. Gallagher, MD
• Halena M. Gazelka, MD
• Nicholas Hagemeier, PharmD, PhD
• Sharon Hertz, MD
• Jan Losby, Ph.D.
• Michael J. Lynch, MD
• John McGraw, MD
• Mary W. Meagher, PhD
• Linda Porter, PhD
• John V. Prunskis, MD
• Mark Rosenberg, DO
• Molly Rutherford, MD
• Friedhelm Sandbrink, MD
• Bruce A. Schoneboom, PhD
• Vanila M. Singh, MD
• Cecelia Spitznas, PhD
• Cindy Steinberg
• Andrea Trescot, MD
• Harold K. Tu, MD, DMD
• Sherif Zaafran, MD

Speakers and Briefers

• Farshaad Aflaatuni
• Matt Aldag, PhD
• Rahul Gupta, MD
• Jonathan Bell
• Peter Staats, MD

Government Attendees

• Vanila M. Singh, MD, HHS, PMTF Chair
• Alicia Richmond Scott, MSW, HHS, PMTF DFO
• Alex Azar, II, Secretary, U.S. Department of Health and Human Services (HHS)
• ADM Brett P. Giroir, MD, Assistant Secretary for Health, HHS *
• Charmaine Yoest, PhD, Associate Director, External Affairs, Office on National Drug Control Policy
• Nora Volkow, MD, Director, National Institute on Drug Abuse, National Institutes of Health, HHS
• Demetrious Kouzoukas, Centers for Medicare & Medicaid Services, HHS
• Rahul Gupta, MD, West Virginia State Health Commissioner
• Carolyn Clancy, MD, Veterans Health Affairs, U.S. Department of Veterans Affairs
• Scott Gottlieb, MD, Food and Drug Administration, HHS

Registered Public Comment Attendees

• Lauren DeLuca*
• Jayne Flanders**
• Sanjay Gupta
• Rich Jacob*
• Shruti Kulkarni*
• Michael Kriegel**
• Richard Lawhern*
• Colleen Leners**
• Dania Palanker*
• Maureen Repmann**
• Beth Sauer**
• Rebecca Sidden**
• Janet Sutton**
• Anne Swanson*
• Kristen Wheeden**
• Margaret Wilson*
• Mary Worstell*

Support Staff

• Vanila M. Singh, HHS, PMTF Chair
• Alicia Richmond Scott, HHS, PMTF DFO
• Spencer Atwell, HHS
• Morgan Courbois, HHS
• LaForest Dupree, HHS
• Karen Foster, HHS
• Chanya Liv, HHS
• Monica Stevenson, HHS
• Ashley Watkins, HHS
• Diane Epperson, Ph.D., Booz Allen Hamilton
• Christina Berger, Booz Allen Hamilton
• Matt Aldag, Ph.D., Booz Allen Hamilton
• Jeffery Saeling, Booz Allen Hamilton
• Anthony Vekstein, Booz Allen Hamilton

* Spoke Day 1 Only
** Spoke Day 2 Only
(phone) Joined via phone

Certification

I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.

Dr. Vanila M. Singh, MD

Pain Management Best Practices Inter-Agency Task Force, Chair