Pain Management Best Practices Inter-Agency Task Force September 26, 2018 Meeting Summary – Day 2

Welcome: 9:00 a.m. – 9:10 a.m.

Ms. Alicia Richmond Scott, MSW, Task Force Designated Federal Officer

• Confirmed Dr. John McGraw joined by phone and opened the meeting.  She discussed her role as DFO of the Task Force.  FACA governs this Task Force, as DFO she ensures that no ethical statutes are violated.  The Task Force will vote on draft recommendations.  The Comprehensive Addiction and Recovery Act of 2016 requires that Task Force must propose recommendations one year after initial public meeting (May 30, 2018).
• Roll call of Task Force members was conducted.

Dr. Vanila Singh, MD, Task Force Chair

• Welcomed the Task Force to the second day of the meeting, highlights what was covered the day before, and introduces guest speakers and topics for the day.

Opening Remarks: 9:10 a.m. – 9:30 a.m.

Dr. Lucille Beck, PhD, Acting Deputy Under Secretary for Health for Policy and Services, Veterans Health Administration, U.S. Department of Veterans Affairs

• Highlighted what the VA is doing to support the veteran population regarding pain management.
• Determining best practices for pain management is a critical charge.  Pain is a challenge among veterans.  Veteran pain is often complex, resulting in lifelong moderate to severe pain.  Young veteran population experiences more severe pain than young civilian population.  Chronic pain is common factor among veterans who commit suicide. 
• The VA is adopting a whole health bio-psychosocial model to address pain by implementing a complementary integrated whole health model, pain management teams at all facilities, adopting stepped-model, educating their providers about pain, newly formed pain advocacy office to help them work directly with veterans, and opioid safety initiatives leading to a reduction of opioid prescriptions.
• Storm tool allows providers to have individual dashboard for each patient to assess individual risk.  Results: 45% reduction in number of veterans prescribed opioids in the last year.
  • Primary care teams make decisions about how to manage pain, pain management team support (has led to VA/DoD Stepped Pain Model).  Within the Stepped Model - primary care physicians, pharmacists, patients, and families to address pain and pain management.

• VHA has increased its use of non-pharmacological pain treatments, including
  • Manual therapies such as acupuncture, massage, tai chi, hypnosis
  • Exercise movement therapies
  • Cognitive behavioral therapies
• Whole Health Initiative
  • Model of care currently being implemented and studied at 18 sites, then to be rolled out across VHA systems
  • Personal health plan that veteran develops
  • Veteran treated by clinical care, encouraged to explore what works best for them.
  • Equipping veterans to own their care (through advocacy efforts).
• 57+ initiatives currently occurring.  The VA is working hard to implement and improve practices for pain management.

VADM Jerome Adams, MD, MPH, U.S. Surgeon General

• Currently practicing anesthesiologist, performs ~1 shift/month at Walter Reed National Military Medical Center (WRNMMC) and is trained in acute and chronic pain management.  VADM Adams has been working closely with WRNMMC to ensure veterans are receiving best care, and wants to do that for all Americans.
• All chronic pain starts with acute pain, tend to focus on chronic pain when discussing pain management, but if we do a better job addressing acute pain when it occurs we’ll have less chronic pain. 
• America is facing two problems: improper management of chronic pain as well as opioid addiction.  Public’s comments and feedback is critical to the success of the committee.
• ‘Better health through better partnerships’
  • Strengthening existing public health partnerships and forging new ones
  • All sectors, including business and private sectors, are affected by health but may not realize it.
  • More money spent on healthcare is less money spent on economic growth.
  • We need to help private sector understand than investing in their employee’s health is good for their economic growth.
  • Workers who are healthier cost less to employ and are more productive
  • Untreated and undertreated health have a direct impact on community health and business bottom lines.
• Pain must be treated with the same compassion as other health issues.  Providers must be encouraged to assess patient risk and avoid over- or under-prescribing.  CDC recently released pocket guide for tampering pain medication – provider and patient must work together to develop a plan that will work best. 
• Shift reimbursement model away from pay for service (pay for pills) to pay for outcomes
  • Push providers to encourage different treatment modalities and push insurers to cover them.
• The report to Congress on racial and economic inequities that exist in access to pain management and treatment modalities should be considered.
• September is National Recovery month.
  • People die of overdose every 11 min.
  • Importance of Naloxone available for anyone at risk for overdose
  • Help Americans understand that anyone can access Naloxone.
  • Must understand risk factors.
  • Co-prescribe Naloxone with opioids for pain management.
  • Naloxone is a crucial step, cannot get someone to recovery if they are dead.
• RADM Adams disclosed that his brother struggled with addiction for many years, starting with opioid pills.
• His office recently released spotlight on opioids and digital postcard.
  • Spotlight on opioids is designed to be accessible and read cover-to-cover.
  • Get the truth out there about the science of opioid disorder and the treatments we know that works.
  • Encourages Task Force members and their colleagues to read both documents.
• Sharing information is important but not enough, everyone on Task Force needs to be educators and act.
• Looking forward to report coming out of this, urging the inclusion of health equity in said report.

Pain Management Perspectives: 9:30 a.m. – 9:45 p.m.

Dr. Shari M. Ling, MD, Deputy Chief Medical Officer, Centers for Medicare and Medicaid Services (CMS)

• Offered to hold Q&A sessions for subcommittee’s in October to work through the details of implementation of their recommendations.
• Thanked the Task Force for the work they have done and will do, their commitment to assisting this country and getting it right. 
• High level background:
  • CMS is the largest payer for healthcare services globally.
  • Affects 1 in 3 Americans
  • Disseminate evidence in the spirit of spreading best practices, mindful and strategic in implementation of measurement of value, consider evidence in coverage determinations.
• Better pain management is key component to solving opioid epidemic.
• Have carried HHS objective into CMS roadmap for addressing the opioid epidemic
  • Prevention, treatment, and data
  • The Task Force is a key part of prevention (managing pain using safe, viable alternatives to opioids and opioid overuse).
• Evidence and best practices that is ready to be shared can be disseminated through a variety of CMS vehicles.
• With respect to Medicare, evidence for treatments needs to be true for populations that Medicare serves.
• There are challenges to expanding the alternatives for pain management.
  • Win would be an array of treatment options available for providers and patients
• Sufficiency of evidence for valuable outcome informs CMS coverage
• Clinicians/systems may not be aware of what is already available/covered – want to spread information and make that information available at point of care.
• If evidence is promising but not yet sufficient, they have mechanisms to cover that if it addresses specific scientific questions, is outcome-based, and is targeted at Medicare beneficiary population.
• Medicaid has state flexibilities that are distinct from what Medicare can cover.
• Meaningful Measured Initiative
  • Part of effort to reduce burden
  • Aligns with Task Force’s focus on outcomes, patient-centeredness
  • Allows CMS to measure and drive to high quality, outcome-based care
• Reiterated that CMS relies on and needs evidence.
• CMS is a partner is spreading best practices.
• Focus on the outcomes that matter to the people we service, both pain relief and functionality.
• Thank you for including CMS in this dialogue.

Patient Testimonials: 9:45 – 10:25 a.m.

Jenifer Thurston

• Thanked the Task Force for allowing her to represent individuals suffering from chronic pain.
• She is managing her pain using stimulants in combination with opioids.
• She has a great article she hopes the Task Force can read about the importance of stimulants in the management of chronic pain.
• Stimulants in conjunction with opioids counteracts negative side effects of opioids (haziness, fatigue, low respiratory function).
• Through the VA, she has been unable to receive her prescriptions
  • She also uses a sleep aid, and her psychiatrist said she couldn’t receive that and a stimulant.
  • She takes Adderall and oxycodone twice/day.
  • Other medications caused her to gain weight and suffer from depression.
• Important to consider combination stimulants of opioids for chronic pain management, which is not currently in practice.
• Massage therapy as a treatment for pain management not currently in practice
  • When she has gone to an individual experienced in sports-based medicine twice a month, she has an increased ability to sleep, less anxiety, better balance/coordination/flexibility, dramatic reduction in pain.
  • If she goes once a week, it is even better.
  • She has difficulty driving, so having the individual come to her home reduces a lot of stress.
• Massage therapists comes to WRNMMC/USO twice a month.
  • Always overbooked and helps patients and their caretakers tremendously.
• Massage therapy needs to be ongoing.
• Her limitations:
  • Issues with balance and coordination.
  • She uses heat and strength-based training in addition to the other treatment modalities she mentioned.
  • Unable to drive unassisted, difficulty going up and down stairs, unable to sit in a car for long distances.
  • Has a caregiver.
  • No longer able to lead the active lifestyle she used to.
• Feels a little embarrassed to admit she is on opioids.
  • Uses other treatment instruments to ensure she can stay at a low dose.
• Advantageous to support therapy animals

Julia Litten

• Thanked the Task Force for the honor of having her.
• Her chronic pain is invisible to most people.
• She’s 67 years old.
• Eight years ago through a series of minor events, she endured several spine, disc, and neck injuries.
  • Went to multiple doctors to try to relieve her pain and was told that she was not a candidate for surgery, but few other treatment options were given.
  • She was accused of drug seeking, belittled for having a low pain tolerance, and dismissed.
• Experienced a loss of functionality
• First 6 months was the most difficult
  • Doctors didn’t know if pain would endure and become chronic.
  • She had to prove her pain to doctors and emergency rooms, who often didn’t believe her.
  • Her family was unequipped to cope.
  • Despite no history of mental illness, became depressed and was hospitalized for suicidal ideation three times.
  • Doctors didn’t help – labeled her as an addict and even suggested she go to rehab.
• Two years later
  • Ended up in a Pain Management Clinic.
  • Treated with understanding and respect.
  • Put on a pain patch – very helpful because her pain is constant.
• Changed to a different pain patch because her patch was so expensive even with great insurance, and now that she’s on Medicare it’s not covered at all.
• She has tried many different types of treatments.
• Took a class in mindfulness meditation which has been very helpful for her.
• Acupuncture has been recommended to her but is not covered by Medicare and was not covered by her prior insurer.
  • This has been true for other treatments such as massage
• She sees a social worker weekly for therapy due to depression from her chronic pain
• Pain Connection, part of U.S. Pain Foundation, has provided classes about chronic pain that has helped her learn more about addiction vs dependence, coping mechanisms, and provided her with a support network of people like her.
  • Has recently become co-leader of her support network
  • Teaches medical students at Johns Hopkins about chronic pain
• She and her therapy dog, Teddy, visit others to provide them with support
• Because of her pain she can no longer work, could not drive for three years, her relationships with her family and friends have suffered
• The Pain Management Clinic has allowed her to maintain quality of life
  • She finds the routine urine testing humiliating but considers it her public duty.
  • She is not pain free but feels like a person again.
• Does not want to be on opioids, but her pain is constant, and she cannot function without them.
  • Does all of the other treatments so she can stay at a low dose.
  • Does not have negative side effects, although it does not totally eliminate her pain.
• There is also stigma around mental health/depression/suicide
  • Relationship between chronic pain and depression.

Anne Alfa

• She is a 19 years old, sophomore in college, who struggles with Sickle Cell Disease.
• Her dad has always told her, ‘Sickle Cell doesn’t not have me, I have Sickle Cell’
• She stopped taking opioids because while they took away pain, they didn’t take away pain for good.
• Her passions have helped reduce her pain the most.
  • At one point she was a cheerleader and was able to move and cheer despite being paralyzed at that time.
• She has struggled with depression.
• She had to give up cheerleading; now focuses her efforts on being a patient advocate.
• She has had six surgeries, has migraines every day, but still goes to school and lives her life. 
• Although she struggles with Sickle Cell, her strong relationships with her family has kept her going.
• She takes an active role in controlling her own pain.
• Music is great therapy for her.
  • When she is listening to music, her pain goes away.
• She struggles with fatigue because her disease affects every organ, which has affected her academic studies.
• She wants to go to medical school and become a hematologist to help young people struggling with her disease and families.
• She wants to make a difference and is thankful for the opportunities to speak about her life and her experiences.
• Importance of doctors having a personal connection with their patients
  • She tried to commit suicide and he texted her to not give up and that she’s going to make it big one day, which inspired her to keep going.
• Importance of maintaining a positive mindset.
• She was addicted to morphine at one point in her childhood. That is why she seeks other treatment modalities.
• Dr. Singh highlighted patient testimonials convey that patients self-motivated to find best treatment modalities for themselves

Corey Gritter

• Joined the Marines in 2005, became a sniper.  In 2009, he deployed to Afghanistan where his team was hit by an IED.  He was 10 feet away, was launched in the air and waited three hours for rescue because rescue team was also hit.
• After being in a full body cast, he was sent to WRNMMC.  Given a choice to amputate arm and leg or limb salvage, Mr. Gritter decided to keep both limbs, resulting in long and painful recovery process with 26 surgeries over 3.5 years.
  • Started receiving alternate therapy at the National Intrepid Center of Excellence (NICOE) at WRNMMC.
  • After being an inpatient, told himself he was going to get off all his medications.
    • Had seen too many service members become “zombies full of meds”.
    • Instead, opted for acupuncture which worked very well.
  • Severe pain resulted in trouble sleeping
    • Worked with Dr. Koffman at NICOE with the goals of sleeping better and managing his pain.
  • Recently, he received digital medicine therapy
    • Visual and audio therapy, which somehow triggered feeling in his leg and foot and reducing his pain
    • Three 30 min sessions
    • In his opinion, a lot better than medications.
  • Combination of needles and visual medicine has worked for him and many others, he believes it’s the way of the future.
  • While he chose an alternative route, medications did help him at one point in his recovery.

Dr. Vanila Singh, MD, Task Force Chair

• These testimonials showcase the diversity of pain experiences and the necessity of diversity of treatment modalities to address individual preferences and experiences.
• Patients are not trying to be on medications, they are trying to regain their life.
• Trying to address stigma around opioids, doesn’t want patients to be embarrassed about the treatments that work best for them.
• Opens to Task Force Q&A

Dr. Molly Rutherford, MD

• Patient testimonials show that people are so different, what works for one person might not be the best fit for another person.
• Importance of physician-patient relationship and how one-size-fits all guidelines won’t work.

Dr. John Prunskis, MD

• Pain patient stories are very compelling.
• At his clinic, they have strived to diagnose the source of the pain, and use non-opioid medications (as well as opioids).
• To patients listening, get a proper diagnosis and seek other physicians if you do not get a thorough evaluation, if you are not getting what you need.

Dr. Vanila Singh, MD, Task Force Chair

• Addiction, it's a disease that deserves the compassion, science, and empathy, and all of the innovative means to address and embrace as a society with the social determinants that underlie it.
• Dual crisis of pain and addiction with pain in its own right a symptom/category of disease

Dr. Howard Fields, MD, PhD

• Asked what dose and type of opioid Ms. Julia Litten is on.
  • Ms. Litten: Fentanyl

Dr. Sherif Zaafran, MD

• Applauded the strength of the pain patients
• Please do not feel the stigma of taking an opioid, you need to do what you need to do to live your life
• There is no shame in taking what medications you need to take to be functional
• Do not care if there is peer-reviewed evidence for different treatment modalities, cares if patient feels it improves their life, and if so it needs to be covered/reimbursed

Dr. Andrea Trescot, MD

• Chronic pain is a chronic disease like diabetes, thus opioids are like insulin
  • Things like diet and exercise can help you get off your medication, but there should not be stigma if you need it.
• Opioids allow patients to be functional enough to pursue other modalities.
• Wants to remove stigma around urine toxicology
  • Not supposed to be a gotcha moment
  • Supposed to be helpful in understanding patients’ genetic metabolizing characteristics
• Encourages patients not to give up on pain management and pursuing other treatment modalities.
  • There are many options that these patients might not have been offered yet
  • New treatment options are becoming available to combat underlying pain source, hopefully reducing need for medication

Ms. Cindy Steinberg

• Thanked patients for telling their stories and empowering other patients listening
• Wants Task Force to encourage and facilitate:
  • Empathy of provider towards pain patient
  • Support and education for patients
    • Counseling, understanding the resources
    • Need funding to establish patient education and support group networks, like what SAMSHA does for substance abuse networks

Dr. Rollin Gallagher, MD, MPH

• Affirmed what other Task Force members have said
• Patients demonstrate necessity of multi-modal, patient-centered, whole-person model and treatments
• Confirms what the Task Force has been working on recommending

Dr. Sharon Hertz, MD

• Stated appreciation for the work of the Task Force
• Nothing that the Task Force is recommending is new, instead they have brought together the knowledge that exists but has been forgotten due to priorities shifting from patient care to bare minimum of what is acceptable
• Task Force is here to remind society that pain management is not just handing out a prescription
  • We have demonized opioids and patients who rely on opioids because of addiction problem in this country
• Recommendations are important, but need to really empower providers to follow a balanced approach
  • Primary value needs to be comprehensive pain management, otherwise will continue cycle of pain management is minimalized to handing out a script

Pain Task Force Draft Recommendations: 10:25 a.m. – 11:15 a.m.

Dr. Vanila Singh, MD, Task Force Chair

• Summarized that over the past two days the Task Force has heard from elected officials, patient testimonials and various important guest speakers from federal agencies, and have analyzed data from thousands of public comments
• Thanked the Task Force for bringing their expertise.
• Have the initial recommendations
• Hearing from patients helps guides and grounds the Task Force in addressing their needs
• Fundamental principles:
  • More time for doctors to see patients to help form therapeutic alliance, complete history
  • Complementary, multi-disciplinary, multi-modal approach to pain management in various settings
  • Medications, movement therapies, behavioral health, interventional (invasive) procedures, including nerve stimulations, epidural injections, etc., integrative medicine
  • As a Task Force, they will give thought to best terminology for CAIT
  • Need for education in all realms
  • Improving access to care to ensure best practices are implemented
  • Have called for great, novel research to yield safer, better, more innovative treatments in the future

Deliberation and Vote

• Voting on initial draft recommendations, resulting from hundreds of hours of work from subcommittees.
  • Recognized that recommendations will be reviewed by subcommittees and the Task Force and posted to the public for comments (i.e. voting to release themselves to the next step).
  • Public will be informed when 90-day public comment period will be
    • Date will be announced in the federal register and available on the website
  • Will continue to use machine learning to analyze trends in public comments and update recommendations accordingly
  • Recommendations will be sent to Congress as part of report
• Presenting motion to move draft recommendations forward, that will be part of report released to the public sometime in the coming weeks
  • Dr. Adkinson seconds the motion

• Dr. Linda Porter, PhD
  • Wants to ensure federal agencies will have time to review recommendations and provide their input before document is submitted to Congress
• Dr. Vanila Singh, MD, Task Force Chair
  • Indicated that the Task Force will form report with these recommendations
  • Federal Task Force Members can provide their comments on behalf of their agencies
  • Before recommendations are posted, everyone will make sure they agree
• Ms. Alicia Richmond Scott, MSW, Designated Federal Officer
  • There is no requirement for federal clearance, instead they will take consideration during the public comment period.
• Dr. Bruce Schoneboom, Ph.D.
  • Will vote yes assuming Task Force will use review period to update section he mentioned yesterday
• Dr. Friedhelm Sandbrink, M.D.
  • Understands that draft recommendations will not be cleared by federal agencies, but does need to take document to his agencies leadership and bring their comments back to the Task Force
  • If input will be valuable and considered in the future, he supports the process moving forward
• Dr. Linda Porter, PhD
  • Can it be noted that this is a draft and has not been agency cleared?
    • Dr. Singh, MD, Task Force Chair: Yes
• Dr. Jan Losby, PhD
  • Following the 90-day public comment period an update to the recommendations, will there be another opportunity for federal agency input?
    • Dr. Singh, MD, Task Force Chair: Can set aside some time but must consider meeting the Task Force’s deadline for sun setting
• Dr. Vanila Singh, MD, Task Force Chair:
  • Asks for vote
  • Overwhelmingly: 27 votes yes; 1 no; 1 abstained
  • Moves that meeting is adjourned
    • Seconded

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

• Jennifer Thurston**
• Julia Litten**
• Anna Alfa**
• Corey Gritter**

Government Attendees

• Vanila M. Singh, MD, HHS, PMTF Chair
• Alicia Richmond Scott, MSW, HHS, PMTF DFO

• ADM Brett P. Giroir, MD, Assistant Secretary for Health, U.S. Department of Health and Human Services*
• The Honorable Pete Sessions, Congressman (R-TX)*
• The Honorable Michael Burgess, Congressman (R-TX)*
• Paul R. Cordts, MD, Assistant Director, Medical Affairs, Defense Health Agency, DoD*
• RADM Michael Toedt, MD, Chief Medical Officer, Indian Health Services*
• Walter Koroshetz, Director, National Institute of Neurological Disorders and Stroke, NIH, HHS*
• The Honorable Bill Sessions, Senator (R-LA)*
• Lucille Beck, PhD, Acting Deputy Under Secretary for Health for Policy and Services, Veterans Health Administration, VA**
• VADM Jerome M. Adams, M.D., M.P.H., U.S. Surgeon General, HHS**
• Shari M. Ling, M.D., Deputy Chief Medical Officer, CMS, HHS**

Registered Public Comment Attendees

• Kate Gilliard*
• Heather Parsons*
• Dr. Connie Newman, M.D.*
• Richard Lawhern*
• Kelly Devine*
• Margaret Wilson*
• Trina Waughn*
• Jackie Evans-Shields

Support Staff

• Vanila M. Singh, MD, HHS, PMTF Chair
• Alicia Richmond Scott, HHS, DFO
• Morgan Courbois, HHS
• Karen Foster, HHS
• Rachel Katonak, HHS
• Chanya Liv, HHS
• Rachel McCoy, HHS
• Monica Stevenson, HHS
• Ashley Watkins, HHS
• Diane Epperson, Booz Allen Hamilton
• Christina Berger, Booz Allen Hamilton
• Matt Aldag, Booz Allen Hamilton
• Jeffery Saeling, Booz Allen Hamilton
• Brendan Dolan, Booz Allen Hamilton
• Nicole Miko, 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