Pain Management Best Practices Inter-Agency Task Force May 30, 2018 Meeting Summary – Day 1
Welcome: 9:30 a.m. – 9:40 a.m.
Dr. Vanila Singh, MD, Task Force Chair and Ms. Alicia Richmond Scott, MSW, Task Force Designated Federal Officer (DFO) provided a welcoming statement to the public and Task Force.
Opening Remarks: 9:40 a.m. – 10:10 a.m.
Alex Azar, II, Secretary, US Department of Health and Human Services –
- Acknowledged the inaugural gathering of the Task Force; thanked the Office of the Assistant Secretary for Health (OASH) and Dr. Yoest, Associate Director, External Affairs, Office of National Drug Control and Policy; for convening the Task Force.
- Secretary Azar discussed the responsibility of prescribers, dentists, pharmacists, experts on pain, mental health, and addiction, and military organizations to improve pain management in America.
- He acknowledged that the Comprehensive Addiction and Recovery Act (CARA) was the first major legislation to address mental health, addiction and pain.
- Physicians have often found that pills have been the quickest option to treating pain.
- Secretary Azar emphasized that the opioid epidemic has caused 40,000 deaths each year.
- He expressed that the Trump administration is seeking to reduce the opioid supply by reducing the prescribing rates of opioids, along with interdiction.
ADM Brett Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services –
- ADM Giroir thanked Dr. Singh and Ms. Richmond Scott for their hard work in convening the Task Force.
- He noted that CARA is a critical component in addressing pain management, addiction, and substance abuse.
- He recommended multimodal therapies in treating chronic pain.
- ADM Giroir emphasized the need for seeking input from the public during the meeting.
Dr. Charmaine Yoest, PhD, Associate Director, External Affairs, Office on National Drug Control Policy –
- Dr. Yoest provided her personal account of pain management during her cancer treatment.
- ONDCP considers pain management as a very serious issue.
- She noted that the United States loses 100 people per day to the opioid epidemic, and the rising number contributes to a lower life expectancy in the United States.
Task Force Member Introductions: 10:10 a.m. – 10:40 a.m.
- Dr. Vanila Singh, MD, Task Force Chair, introduced the Pain Management Best Practices Inter-Agency Task Force members and provided a brief biography for each member:
- Dr. Sondra M. Adkinson, PharmD
- Dr. Adkinson is a Clinical Pharmacist with over 15 years of experience and serves as the Pharmacy Pain Program Manager and Pain School Facilitator at the Bay Pines Veterans Health Administration.
- Dr. Amanda Brandow, DO, MS
- Dr. Brandow serves as the Chair of the American Society of Hematology and as an Associate Professor of Pediatrics at the Medical College of Wisconsin with over a decade of experience providing care for individuals with sickle cell disease (SCD) and acute and chronic pain.
- Commander René Campos, MBA
- Commander Campos retired as Commander of the U.S. Navy after a 30-year career, and now represents active duty, Guard and Reserve, retirees, Veterans, survivors, and family members as the Senior Director of Government Relations at the Military Officers Association of America.
- Dr. Jianguo Cheng, MD, PhD
- Dr. Cheng is President of the American Academy of Pain Medicine, and has served on its Board of Directors since 2014 as Director-at-Large and Vice President for Scientific Affairs.
- Dr. Daniel Clauw, MD
- Dr. Clauw currently serves as the Director of the Chronic Pain and Fatigue Research Center and as a Professor of Anesthesiology, Medicine, and Psychiatry at the University of Michigan.
- Dr. Jonathan C. Fellers, MD
- Dr. Fellers is currently the Medical Director of the Integrated Medication-Assisted Therapy at Maine Medical Center and also serves on the Co-Occurring Disorders Service-Line Lead, Buprenorphine Prescribers Committee, Center for Psychiatric Research, and Leadership Committee.
- Dr. Howard L. Fields, MD, PhD
- Dr. Fields was a founder of the UCSF pain management center and has made major contributions to understanding and treating neuropathic pain where his current research is focused on the neurobiology of opioid analgesia and reward.
- Dr. Rollin M. Gallagher, MD
- Dr. Gallagher is Emeritus Investigator at the Veterans Affairs (VA) Center for Health Equity Research and Promotion, and he is currently the Director for Pain Policy Research, Primary Care, and Penn Pain Medicine at the University of Pennsylvania.
- Dr. Halena M. Gazelka, MD
- Dr. Gazelka is currently the Director of Inpatient Pain Services in the Division of Pain Medicine at the Mayo Clinic and also serves as the Chair of the Opioid Stewardship Program and as an Associate Medical Director for Mayo Clinic Hospice.
- Dr. Nicholas Hagemeier, PharmD, PhD
- Dr. Hagemeier is an Associate Professor and Co-Investigator of East Tennessee State University Gatton College of Pharmacy’s $2.2 million NIH-funded Diversity-promoting Institutions Drug Abuse Research Program.
- Dr. Michael J. Lynch, MD
- Dr. Lynch currently serves as the Medical Director of the Pittsburgh Poison Center, an Assistant Professor for the University of Pittsburgh, Department of Emergency Medicine, and as an Adjunct Assistant Professor for the West Virginia University School of Medicine.
- Dr. John McGraw, MD
- Dr. McGraw is a retired Colonel having served in both the U.S. Air Force and U.S. Army for a combined 34 years of commissioned service and is now currently serving as the Medical Director of OrthoTennessee, which is the largest orthopedic clinic in Tennessee with more than 100 providers.
- Dr. Mary W. Meagher, Ph.D.
- Dr. Meagher is a Professor of Psychology and Neuroscience at Texas A&M University where her research focuses on the role of stress and emotion in health, with an emphasis on pain and inflammatory conditions.
- Dr. John V. Prunskis, MD
- Dr. Prunskis is founder and co-Medical Director of Illinois Pain Institute and is a Clinical Professor at Chicago Medical School.
- Dr. Mark Rosenberg, DO
- Dr. Rosenberg is Chairman of the Emergency Department at St. Joseph’s Health in New Jersey and leader and developer of the nationally recognized Alternatives to Opioids program (ALTO).
- Dr. Molly Rutherford, MD
- Dr. Rutherford is Founder of Bluegrass Family Wellness, PLLC in Crestwood Kentucky, serving as a certified addiction specialist treating patients on the front lines of the opioid epidemic.
- Dr. Bruce A. Schoneboom, Ph.D.
- Dr. Schoneboom is currently the Chief Learning Officer at the American Association of Nurse Anesthetists, and also Adjunct Faculty at Texas Christian University and Johns Hopkins University School of Nursing.
- Ms. Cindy Steinberg
- Ms. Cindy Steinberg is the National Director of Policy and Advocacy at the U.S. Pain Foundation, and Policy Council Chair of the Massachusetts Pain Initiative.
- Dr. Andrea Trescot, MD
- Dr. Trescot is the Past President of the American Society of Interventional Pain Physicians and currently serves as the Director of the Pain and Headache Center in Eagle River, Alaska.
- Dr. Harold K. Tu, MD
- Dr. Tu is currently the Director of the Division of Oral and Maxillofacial Surgery at the University of Minnesota School of Dentistry, and Chairman of the Department of Dentistry at Fairview Hospital.
- Dr. Sherif Zaafran, MD
- Dr. Zaafran was appointed as the current President of the Texas Medical Board by Governor Greg Abbott, and also serves the President of the Memorial Hermann Division of U.S. Anesthesia Partners in Houston.
Opening Remarks: 10:55 a.m. – 11:20 a.m.
Dr. Vanila Singh, MD, Task Force Chair, provided an overview of Task Force’s charge:
The scope of the charge is limited to the specific legislation established under Public Law 114-198, Section 101 Comprehensive Addiction and Recovery Act (CARA) of 2016 or CARA.
- On July 22, 2016, CARA was signed into law as a comprehensive and coordinated response to the opioid epidemic.
- The Pain Management Best Practices Inter-Agency Task Force was authorized by CARA to study and develop best practices for treating acute and chronic pain.
- CARA also requires that the Task Force convene no later than 8 years after the date of the enactment of the Act (July 22, 2018).
- 1 year after the date on which the Task Force convenes, the Task Force must propose updates to best practices and recommendations and submit them to relevant Federal agencies and the general public.
- The Task Force is to sunset 3 years after the date of enactment (July 22, 2019).
- The duties of the Pain Management Task Force are to:
- Identify, review, determine, and propose updates to gaps or inconsistencies between best practices for pain management, taking into consideration:
- Existing pain management and relevant research;
- Relevant conferences and existing evidence-based guidelines;
- State and local level efforts and by medical professional organizations;
- The management of high-risk populations who receive opioids for medical care;
- The 2016 Guideline for Prescribing Opioids for Chronic Pain issued by the CDC; and
- Private sector efforts.
- The legislation authorizes $181 million each year to be allocated towards six pillars:
- Law enforcement
- Criminal justice reform
- Overdose reversal.
- Provide the public with at least 90 days to submit comments on any proposed updates and recommendations.
- Develop a strategy for dissemination of information about best practices for pain management to stakeholders.
- This Task Force specifically will focus on best practices, clinical guidelines, gaps and inconsistencies and then recommendations based on those findings.
Pain Management Testimonials: 11:20 a.m. – 11:40 a.m.
Invited members of the public shared patient testimonials regarding their experiences with pain. The following includes a brief synopsis of the patient testimonials.
Mr. Farshaad Aflaatuni –
- Mr. Aflaatuni spoke about trigger-point injections and Botox helping his pain. He stated that it helped regain his life.
- He expressed that the Botox injection was a huge breakthrough for his migraine pain. Every four months, he is totally pain free. As it gets closer and closer to that four months, he needs another injection.
- He described how Reiki or touch healing helped him. He acknowledged that it is not a cure, but it gave him power to face problems, and calmed him. He also occasionally takes an opioid, Tylenol Number 3, for his pain.
- Mr. Aflaatuni called for more pain management across the country. He believes additional pain clinics would result in more employment and less overdoses.
Mr. Jonathan Bell –
- Mr. Bell described that he is a part of a 12-person family with 5 members of that family having sickle cell. He explained that during his upbringing, he never experienced treatment that was specific for the treatment of sickle cell.
- He asserted that opioids have helped him reach a certain quality of life that is sustainable. His expressed that his family believes in using less medication, rather than more.
- At age 15, Mr. Bell experienced a crisis and was taken to hospital where doctors gave him a standard amount of opioids as used to normally treat sickle cell but due to lack of receiving medication his entire life the dosage almost killed him.
- He reaffirmed that his opioids have helped him get a quality of life. He has learned to adapt to his condition. Oxycodone was a medication that he was taking at a certain time. He also maintains a healthy diet to assist with his condition.
- Mr. Bell discussed understanding that doctors have misgivings about writing large amounts of prescriptions for opioids when they do not understand how the usage will be used (abuse or not). He wants doctors to look specifically at patients rather than a generalist view and to make sure doctors understand each case.
Ms. Emily Lemiska –
- Ms. Lemiska, who lives with a debilitating spinal condition, likened the pain she lives with to hitting your elbow very hard and have that feeling never go away. She noted that an estimated 23 million Americans are affected by these conditions.
- Ms. Leminska needed surgery which removed spinal discs and portions of her central nervous system. Her spine is sensitive to any sensation. She has tried almost every therapy (e.g., pain therapy, physical therapy, acupuncture, meditation etc.) and she wears a brace.
- Ms. Leminska believes she needs her medications but often feels like a drug seeker when trying to obtain prescriptions.
- Waiting times due to a variety of issues are debilitating to many people across the country.
- She noted that costs are absurdly high when considering pain. Her massages, injections, and opioid alternatives are very expensive especially when compared to her opioid medication.
- Ms. Leminska believes that people with pain are 2 times as likely to commit suicide.
- She recommended increasing coverage, requiring more pain management training in school, and providing education to the public on mixing medications that can serve as viable solutions that help individuals in pain.
Mr. Lino Montes –
- Mr. Montes, a veteran of the United States Army and a physical education teacher, described having severe chronic pain for the past 5 years, which are related to injury and diabetes. He did not know that he had diabetes until he retired. His pain is diagnosed as peripheral neuropathy.
- Mr. Montes explained that he takes an opioid, Oxycodone while he awaits spinal cord stimulator which is delayed due to diabetes worsening. He discussed also using water exercises, foam rolls and massages on his feet. He utilizes compression socks and compression boots as well to assist with his pain.
- Mr. Montes explained that due to his recalcitrant diabetic state and high risk for poor wound healing he is unable to have the spinal procedure that would enable him to stop taking opioids.
- Mr. Montes noted that he does not take medication during school time.
Public Comment: 11:40 a.m. – 12:10 p.m.
Ms. Richmond Scott, Task Force DFO, announced that, per the Federal Advisory Committee Act, members of the public are provided the opportunity to give oral and written comments on the issues to be considered by the Task Force. Ms. Richmond Scott requested that speakers limit their public comments to no more than three minutes and said that the public comment period will not exceed 30 minutes. Below is a summary of the comments shared by the public.
Richard Lawhern –
- In the state charts there is a CDC chart that shows the relationship between raw rates of opioids by states vs the relationship vs deaths by opioids. However, the relational data does not hold any truth to i-t because the amount of prescribed medicine is not present when considering the drug abuse in this country.
- The risk of opioid related death is comparable to death by blood thinners. This is not the same as an addiction and should not be confused. The rate of death by medical patients is .05 percent and can be further reduced by medical training. The optimal therapeutic dose is far beyond the guidelines given by the Task Force. They are erroneous and need to be updated as appropriate.
Shruti Kulkarni, Aimed Alliance –
- Aimed alliance recommends that future best practices be grounded in scientific literature.
- We recommend that DOJ obtain an evaluation from state professional licensing boards before initiating criminal investigations on licensed healthcare professionals.
- Prescriber education should be a prerequisite for the federal controlled substance registration.
Anne Swanson –
- Nurse 30 years in the field; We offer an alternative solution for acute pain. Instead of opioids we offer a continual nerve block. We are more of a prevention side by utilizing this more before we get to chronic pain.
- When CMS looks at it, it is cheaper to give a patient pills rather than nerve blocks. When we consider what happens to medications though we should be considering this more. There is a sense of urgency here because being able to receive a refund for this will be huge for people.
Margaret Wilson, Alliance for Treatment for Pain –
- There are serious discrepancies for chronic pain.
- Doctors have been pressured to prescribe opioids by CDC and DOJ. These measures were met when limited evidence existed to provide correct guidance.
- There is no evidence for causation of opioid prescriptions vs death. This is not the case for un-prescribed drugs such as fentanyl and heroin.
- We need to develop strategies for best practices and literature for acute and chronic pain. 2016 CDC Guidelines should be recalled and so should others regarding this issue as they are statistically incorrect and wrong. Pain management is critical for better life and better health.
- Please help reverse the policies that are hurting patients.
Mary Worstell, Retired HHS –
- Ms. Worstell explained the difficulties of Mary, a friend living in chronic pain. At 50 she faces extreme pain when urinating. She was placed on full disability since 1990. Mary will never recover or improve and has faced more pain diseases such as fibromyalgia and more. In 2008, she was forced to go to a new doctor and was not approved for medication until three months later. She was told any person taking opioids was a drug addict. With assistance and help Mary was forced to sign opioid control to receive the care she needed. She as a result, she was in more pain than ever and could not control it or urinate. She had no sleep for 5 days and was unable to be treated. Hospital was unable to help and could not prescribe opioids. She eventually passed out in the kitchen causing brain and head injuries. She has met with a new PCP to help her get the medication she needs but is still having trouble. I want you all to know her story.
Dania Palanker, Georgetown Health Insurance Policy –
- We need a multi leveled approach to pain management. Our current structures are not developed be able to cover all of this.
- Problems with rehabilitative services – only covered if there is an improvement in certain care and condition.
- People who maintain condition with PT are often excluded because it just maintains pain levels and doesn’t improve it. Other issues also fall under access to networks.
- When looking for someone experienced with caring for pain, the provider will often be out of network.
Dr. Sanjay Gupta, MD –
- Focused on calling out the bad actors.
- They are making it worse for the good ones. I think the key is to focus on trying to find the bad actors who are making lives more difficult for their patients. Better training and education need to be given to staff.
- An example was an attorney who approached me with a doctor who had 10 deaths over a few years. Even with all the deaths nothing has happened to this doctor. No investigation was ever started because there was no complaint ever submitted. The issue being families look at internal issues and people issues instead of doctors’ practices.
Lauren DeLuca, Chronic Illness Advocacy and Awareness Group –
- Has brought in 33 organizations that agree that the issue of pain is often with government mandates and guidelines that are incorrect and need to be updated. Many patient suicides were found to be prescribed below the recommended amount, clearly showing they were not able to bear the pain.
Scientific Landscape: 1:10 p.m. – 1:25 p.m.
Dr. Nora Volkow, MD, Director, National Institute on Drug Abuse –
Dr. Volkow provided a high-level overview of the scientific landscape. The following is a synopsis of her presentation:
- Dr. Volkow expressed that there is an over reliance on opioids for the management of pain.
- Dr. Volkow recommended developing alternatives to opioids for pain management to prevent patients seeking pain relief through opioids.
- She highlighted the relationship of the prevalence of the condition versus the amount of money that has been invested reveals that pain is at the worst. It has the highest impact but lowest investment. Maybe the issue lies in our identification and understanding. There has been major advancement in understanding of the nerves and molecules that work with pain.
- She noted that asking patients to subjectively rate their amount of pain may not be the best method for understanding pain. Science has advanced to show bio markers to help predict and determine the amount of pain the person is having and the type of drugs that will help the most. Many neurological signatures have been discovered to help determine the intensity of the subjective nature of pain.
- Dr. Volkow also noted that there is a need to better target the type of pain that patients are experiencing. She believes that the potential of developing new medication that can deal with the specific signals that are causing pain is the most exciting aspect of this.
- She expressed how there is tremendous variability in pain and that physicians need to tailor interventions specifically to the patients. The variant in genes is associated with a lower concentration of OPRM1 receptors in the brain.
- When addressing the issues of pain, physicians need to ensure that they are also addressing chronic pain. This needs to be a key priority. How do physicians accelerate the development of bio markers so that they may be utilized? Ultimately, for these items to be useful for patients they need to develop these bio markers and systems for custom patient invention.
Clinical Guideline Landscape: 1:25 p.m. – 1:40 p.m.
Dr. Matt Aldag, PhD, Booz Allen Hamilton –
Dr. Aldag provided a high-level overview of the clinical guideline landscape from the Environmental Scan that reviewed the subtopic areas of the scan and the findings. The following is an overview of his presentation:
- These methods driven were made to support the objective of the CARA legislation. The Scan is intended as an overview of best practices seeking to support and inform the work of pain management. To develop these methods, the Booz Allen team worked with Dr. Singh to develop clinical best practices:
- The three methods and breakdowns: Research, Analysis, and Description.
- It is important to emphasize that these questions were written to address the writing of the CARA legislation.
- First was a comprehensive search of PubMed and the NIH database for scholarly and scientific articles on pain management and clinical best practices. Second was a web search of pain management stakeholder organizations. Third was an online search for pain management conferences to determine whether these meetings disseminated best practices.
- Some best practices addressed pain management broadly, others were focused on opioids specifically. Some were broadly ranged for all types of individuals while others focused on cancer, HIV/AIDS, etc. Some even focused in the emergency room or in life-or-death situations.
- The team found that some clinical best practices were based on other best practice recommendations when searching for research. Ultimately organized across 5 disciplinary approaches. These approaches are medications, PT, surgical and minimally invasive procedures, and complementary and alternative medicines.
- There are multiple pain management topics that fall under these approaches. The Environment Scan addressed each topic. Some of these topics, which are starred in the presentation, directly address topics shown by the CARA legislation.
- The Booz Allen research team identified clinical best practices relevant to pain management topics specified by CARA.
- Few made definitive recommendations about optimizing treatments based on differences within and between classes of opioids.
- Clinical best practices suggest that abuse-deterrent technologies can be partially effective in the prevention of opioid abuse or misuse and should be used as part of a multifaceted-approach.
- Clinical best practices provide recommendations for the management of high-risk populations, including prioritization of non-opioid interventions.
Pain Management Current Perspectives: 1:40 p.m. – 3:30 p.m.
Perspectives from the Federal, regional and professional association efforts around pain management will be shared.
Dr. Vanila Singh, MD, Chief Medical Officer, Office of the Assistant Secretary for Health, HHS –
Dr. Singh provided an overview on the HHS five-point strategy. The following is a synopsis of her presentation:
- Better addiction prevention, treatment, and recovery
- Better data
- Better pain management
- Better targeting of overdose-reversing drugs
- Better research
- HHS encompasses FDA, CDC, NIH, PHS, SAMHSA, CMS, HRSA.
- HHS knows that folks are pointing to the fact that when 183,000 people died from 1999-2011 in the first wave. The methadone death rate increased 6-fold from 1999-2007
- There is a rise in heroin deaths. Over 70k have died since 2010. Deaths have increased 4-fold since 2010,
- The rise in synthetic opioids deaths has increased from 3k in 2013 to 9.5k in 2015. Synthetic opioids have increased three-fold.
- The goal is to strike a balance. Identify that these are two issues and they exist. The move has shifted from licit to illicit. These are well documented from all areas. The issue needs to be balanced for acute and chronic pain.
- OASH and NIH first coordinated plans to reduce the burden of chronic pain in the US and to achieve a system in which all people receive high quality, evidence-based pain care.
- The FDA is also working toward creating greater access for patient activities. Also expanded extended-release and long-acting opioid analgesic risk evaluation and mitigation approaches.
Mr. Demetrious Kouzoukas, Centers for Medicare & Medicaid Services (CMS) –
Mr. Kouzoukas provided an overview of the CMS perspective. The following is a synopsis of his presentation:
- CMS has an array of tools that can affect the treatment of pain disorders and pain management.
- CMS has many representatives and subject matter experts that are focused on this priority.
- With respect to prevention, CMS’s goal is to help physicians and patients with unique and specific needs. CMS is identifying overuse and misuse by patients, doctors, coordinators, etc. Next year, they are looking to have opioid fill limits to help control.
- These efforts focus on and address lack of physician understanding with their patients and pain. CMS is adopting an approach that works in tandem with the efforts between prescribers.
- Currently, CMS is incorporating substance abuse programs. They are expanding access to non-opioid pain treatments to offer more choices for pain management.
- This is an area where the work of the Task Force will be beneficial to reduce the use of opioids to manage pain.
- CMS is assuring coverage and overdose reversal will be covered. They are supporting innovation and model development. CMS is also considering models being implemented by the CMS innovation center.
- CMS currently has Medicare part D data analyzed which is starting to be shared amongst 49 states that are submitting Medicare data that will help monitor Medicaid populations across states. CMS is starting a program to help states with analytics. CMS has already seen positive results on a considerable number of projects on many fronts.
Dr. Friedhelm Sandbrink, MD, US Department of Veterans Administration (VA) –
Dr. Friedhelm provided an overview of the VA perspective. The following includes a synopsis of his presentation:
- Chronic pain is more common in veterans than in the non-veterans US populations. It is more severe in the context of comorbidities.
- After 6 million veterans received health care, more than 2 million have chronic pain diagnosis. The amount of diagnosis with chronic pain is increasing.
- Veterans are at a higher risk than non-veterans.
- The 2015 report showed that the most frequently identified risk factor among veterans who died by suicide was pain.
- PACT is the medical home coordinated care and a long-term healing relationship instead of episodic care based on illness.
- The goal of primary care is to provide coordinated care and create long term healing relationship between the providers and patients.
- The model includes all the steps for pain care. Primary care needs to have access to multiple therapy options without any gate keepers. Primary care needs to be supported and follow patients who have complex pain conditions.
- Primary care need to have integrated access to addiction treatment. The goal is to have collaborative care between primary and pain care. It also needs to support the veterans and the providers depending on the individual needs.
- OSI – opioid safety initiative expanded nationally in 2013. Shifts away from opioid therapy for chronic pain management towards multimodal biopsychosocial pain care. OSI aims to reduce reliance on opioid analgesics for pain management and to promote safe and effective use when indicated. Provider education and expansion of non-pharma therapies. OSI dashboard make the totality of opioid use visible within the VA.
- Within the VA, the peak of prescribing was 2012 and since then a 44 percent reduction has been given in opioid use. All the parameters that the VA has been tracking have been decreasing over the last few years.
- 80 percent of the patients who died had low opioid dosages.
Dr. Sherif Zaafran, President, Texas Medical State Board –
Dr. Zaafran provided a regional perspective as the President of the Texas Medical Board. The following is a synopsis of his presentation:
- From the regulatory standpoint- three areas to look at: pain management rules, clinics, and prescription monitoring.
- The rules in Texas meet the following requirements:
- Evaluation of the patient including specified documentation in the medical record.
- Prior to prescribing, must consider reviewing a patient’s prescribing data and history as well as a baseline toxicology screen. If practitioner determines that these aren’t necessary, the rationale must be documented in the patient’s medical record.
- Written treatment plan documented in the medical record.
- Informed consent and agreement for treatment.
- Periodic review to assess progress toward treatment goals.
- Consultation and referral to experts as necessary.
- Pain Management is clearly defined in Texas. Defined as: a publicly or privately-owned facility for which most patients are issued, monthly, a prescription for benzodiazepines, barbiturates, or carisoprodol, but not including suboxone.
- SB 911 (81R) - requires registration of clinics with TMB and authorizes inspections to address the proliferation of illegal pain clinics in Southeast Texas and was based on similar legislation passed by Louisiana.
- 168.201 - owners, operators, employees, or persons the clinic contracts for services may not have licensing issues for prescribing, dispensing, administering, supplying, or selling a controlled substance.
- SB 315 (85R) Key Elements in further regulating PMCs:
- Deaths from opioids declared a public health crisis
- Controlled substances – needs to be closely regulated. Adopt guidelines for the prescription of opioid antagonists and identifying patients at risk of an opioid-related drug overdose and prescribing that patient with an antagonist.
- TMB inspection authority - registered and suspected unregistered PMCs
- TMB has determined that opioids are controlled substances that need to be closely regulated. TMB has allowed first responders to have opioid regulator to help save lives.
- TMB uses a PMP (prescription monitoring program)
- TMB works with Texas State Board with pharmacies to identify prescribing practices that may be potentially harmful and patient prescription patterns that may suggest risk factors or misuse.
- Requires with certain exceptions that physicians or PMP view patient data before prescribing opioids benzo, barbiturates, or carisoprodol.
- Other challenges include: Cost of opioid vs non- opioids as covered by insurers. Many choices patients make will be economical.
- Regulatory Balance – striking the appropriate balance between public protection and practical regulations and enforcement actions that do not unduly hinder legitimate practice.
- Education – Teaching and incentivizing our practitioners on the use of multimodal pain management and invasive procedures to manage pain.
- Continuous Assessment – of rules and procedures to address statutory changes, stakeholder concerns, trends seen in the enforcement process, unintended consequences, etc. (Safe drug disposal, triage of patients who lose access to prescription opioids to prevent progressing to illicit uses).
Dr. Rahul Gupta, MD, West Virginia State Health Commissioner –
Dr. Gupta provided a regional perspective as the West Virginia (WV) State Health Officer and Commissioner for the West Virginia Department of Health and Human Resources Bureau for Public Health. The following is a synopsis of his presentation:
- WV conducted a social autopsy that turned data evaluation to policy.
- These guidelines shown in the presentation carefully balance the prescribing of medications but also leaves a significant gap for best practices to be included.
- Guidelines for the CDC are just guidelines – they are not laws. High MME is not cause of the data. It’s important to recognize data driven solutions.
- It’s imperative for the work in WV to not stigmatize the individuals who are using opioids and medications responsibilities every day.
Medical and Professional Association Presentation
Dr. Andrea Trescot, MD, Director, Pain and Headache Center –
Dr. Trescot provided an overview from the medical and professional associations’ perspective. The following is a synopsis of her presentation:
- When considering pain, there is often a clear miss-diagnosing. Physicians perform careful x-rays and consider physical malformations and diagnostic injections. Treatment- “you cannot treat what you cannot diagnose”
- The use of many medications, processes and methodologies will be needed. This is a continuum to bring a variety of stakeholders to figure out solutions and answers.
- Patient-centered care is important and should not be forgotten.
Dr. Peter Staats, MD, Chief Medical Officer, National Spine and Pain Centers –
Dr. Staats provided an overview from the medical and professional associations’ perspective. The following is a synopsis of his presentation:
- There has been a call for balance. When CDC released their guidelines, there were 2 schools of thoughts: one being no opioids and the other was whatever was needed to treat pain.
- There was an uncontrolled pain problem: uncontrolled pain is a tremendous health crisis, there is a lack of quality of education around pain management and addiction.
- Another issue is the problem of reimbursement.
- Insurers need to be part of the solution. Issues arise when a patient is prescribed certain medication and the insurance company will come back and say this is too expensive, or this is experimental when it’s not, and a slew of other excuses when it should not be their decision.
- Patients need to have access to alternatives moving forward. Evidence-based medicine is the conscientious explicit and judicious use of current best evidence in making decisions about the health care of their patients.
- Evolving therapies for headaches are occurring. There is a larger population of patients who have migraines and are on opioids than those who have migraines and are not on opioids. This can easily be amended by other solutions. Other therapies exist but most are still not reimbursable.
Dr. Asokumar Buvanendran, MD, Chair, Committee on Pain Medicine, American Society of Anesthesiologists –
Dr. Buvanendran provided an overview from the medical and professional associations’ perspective. The following is a synopsis of his presentation:
- Discussing acute pain. American Society of Anesthesiologists (ASA), supports policies and best practice that minimizes opioid use and minimizes misuse.
- It is critical to realize that each surgical procedure is very different. A postoperative physician is needed to evaluate the number of opioids our patients are going home with to minimize the secondary use of them.
- Surgical experience can be a patient’s first exposure to opioids. For some patients that exposure can ultimately lead to opioid abuse and misuse.
- Opioid sparing techniques can treat pain with different combinations of drugs targeting different pain pathways. Multi-modal techniques can be utilized from the pre-operative period through post-operative to help reduce the pain and opioid use of patients leaving the surgical room.
- It is not just about prescribing the quantity of opioids but the quantity with the multimodal regime to help provide the best care for that patient.
- The ASA has partnered with the AAOS to provide recommendations for acute postoperative pain management for orthopedic surgery of varying intensity.
- Large hospitals have undertaken several of these programs but disseminating this info to smaller hospitals is critical.
- Acute pain can lead to chronic pain. It’s important to realize that patients do not get exposed to opioids during this stage. It is possible to reduce this lead from acute to chronic pain and prevent the abuse and transfer from acute pain to chronic pain.
Task Force Discussion of the Pain Management Current Perspectives Presentations
Dr. John Prunskis, MD –
- In our practice we have greater success in reducing opioids by diagnosing the source of pain. We also utilize multiple different medications before trying opioids.
- We never agreed with the lack of risk of addiction as argued in the 90s. It is the synthetic fentanyl and heroin being brought from different countries that are causing such deaths.
Dr. Mary Meagher, MD –
- Pain is in the brain - we are missing the core problem with pain. When we think of the source it’s a bi-directional process with both source and mind.
- There is a huge psychological overlay when it comes to pain management. It is not in isolation but too often we blow it all because we couldn’t find it on a MRI.
Dr. Molly Rutherford, MD –
- Most patients don’t have access to pain specialists. What I’m seeing now from primary care doctors is fear from prescribing controlled substances.
- One obstacle that will be difficult will be the DEA overarching everything. Should we leave this to the doctor? Or can we pass this to another agency?
Dr. Mary Meagher, MD –
- In my experience the overprescribing curve goes right along with the number of overdoses. Now we may have swung too far the other way. I don’t think we have created addicts but I see that many are already at high risk. There are not enough pain specialists out there.
Dr. Mark Rosenberg, DO –
- Our program is one of prevention and treatment with a focus on alternatives on top pain syndromes. If you prescribe chronic pain and acute pain you should be willing to provide medical assistance to help get them off.
- Many patients come in because they got confused whether they took a pill or not often overdosing unintentionally. People feel relieved knowing that first responders and family have the ability to quickly reverse overdose.
Ms. Cindy Steinberg –
- We need to think how to support those PCPs. PCPs should have consultants at no charge to help educate on alternative pain management and solutions.
- People with substance abuse disorders and chronic pain are often seen as one but they are not. We need to treat them differently as their treatment is quite different.
Pain Management Panel: 3:45 p.m. – 4:45 p.m.
During this moderated panel, solutions to pain management challenges from a clinical perspective were discussed.
Dr. John Prunskis, MD –
- It’s important to establish diagnosis and to use not opioid medicine whenever you can. Huge burden for PCP is the electronic health record. I believe this because there is meaningless data that needs to be entered in the EMR before they can see the patient. EMR is adding too much time to a physician’s day to day. It is easier and more cost effective to write an opioid prescription than provide the correct care.
Ms. Cindy Steinberg –
- The biggest challenge is access to care in the broader sense. Not a single person in pain I’ve seen in my history hasn’t seen at least 4 or 5 practitioners before receiving treatment.
Dr. Harold Tu, MD, DMD –
- I implemented a protocol that looked at use of non-opioids. Dentistry is one of the highest prescriber of opioids in industry. It was implemented in Feb. of 2016 and since implementation of the protocol, opioid use has reduced by 80 percent. I think the message here is that not only should this be done but it can be done.
Dr. Jan Losby, PhD –
- One of the important struggles are the patients who have difficulty accessing care, denied care, or without care.
- The CDC guidelines were enacted to help PCPs have guidelines to follow when prescribing. This needs to be coupled with pain management in order to round out the guidance. This needs to be included in medical schools and have additional education in regard to pain management.
Dr. Sondra Adkinson, PharmD –
- I do see the team model working in this scenario. Listening long enough to assist yourself with the diagnosis can often help you get to the goal faster. We try to get the patient to become actively involved. We started in the opioid removal to target the symptom relief of some of their pain. There we saw the patient between physician visits and with the EHR we could help with the process.
- There are multiple schools with pain management courses in the first year. Each medical student spends a week in the second and 4th year in a pain clinic to help further their understanding. This is still way too little.
Dr. Bruce Schoneboom, PhD –
- We need to figure out how we can get the care to our pain patients. The other perspective is the nursing perspective. We need to leverage these folks to make the most of them and deliver the highest quality care.
Dr. John McGraw, MD –
- We realized one of our biggest shortcomings was with our patients. We are not the great communicators we realized or thought we were. We need to learn how to talk to our patients better. We instituted a program at dental school where each physician had to see a behavioral specialist first.
Dr. Michael Lynch, MD –
- Telehealth is going to be an important part of access. As an emergency physician I need to consider how long you’re going to be in pain and how to get you to the next person. I suspect there could be more guaranteed earlier, prior to the follow up with a PCP. Doesn’t have to be in an office but the evaluations need to happen. I suspect fewer opioids would be needed and patients would feel better with better evaluation. While pain free is not achievable, reduction is.
Dr. Sharon Hertz, MD –
- If we are going to focus on a single approach we will continue to fail patients on a regular basis. We need to look at a continuing basis of multi-disciplinary and meaningful way. We need to look at the whole and at things that need to be managed long term.
- When we’re talking about a multi modal approach, you can build that approach using that same framework. I don’t think we need to reinvent a lot of things. In fact, we do a lot of this already but we need to employ in a smarter and more thoughtful manner.
Dr. Jianguo Cheng, MD, PhD –
- I think this is important to identify the patients in need. What do they have? Acute, chronic or end-of-life pain? Is this addiction treated or untreated? Is it both? Put the patients’ best interest before our own. Can we address the patients’ need? Whether we can have the capacity to do this, preauthorization can act as a big hurdle to overcome.
Ms. Rene Campos –
- I think the greatest challenge in the federal arena, having worked in DoD and healthcare over the years, is to have that commitment from Congress to continue funding these programs. They need to understand that you can’t just legislate things and have things happen.
Dr. Vanila Singh, MD –
There are various levels of perspectives from the 40,000 ft, 10,000 ft level and in the clinical trenches at the patient and provider level.
- Stigma is noted as significant barrier that patients have struggled with in terms of treatment and judgement from society.
- Tele-mentoring as educational means for primary care clinicians (with specialists to help with both education while treating pts)
- Physician burn out remains an issue (admin burden and EHR as well as other regulatory issue)
- Emphasis on translational policy and translational research for best outcomes and clinical care
- Buprenorphine should have coverage treatment for pain treatment
- We spoke about alternative models and extending care to family and care givers.
- There is an understanding that there is an opioid overuse and need to address this and opioid overdose deaths, while ensuring balance with pain treatment for acute and chronic pain patients. We need to consider and answer these questions and make them clear. There is a lot of mistaking one for the other which is leading to much concern.
Wrap-Up and Adjournment: 4:45 p.m. – 5:00 p.m.
Dr. Vanila Singh, MD, Task Force Chair, briefly recapped some overall themes from Day 1’s meeting:
- Coverage of treatment
- DoJ and DEA involvement
- Unintentional overdose
- Expanding treatment
- Alternate models
- CDC Guidelines
- Abandonment of pain patients
- Education – both providers and patients
- Residency level
- Public education issue
- Patient centered model
- Options – multimodal and multidisciplinary
- Patient perspectives from patient testimonials
- Public comments – in person, phone
- 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
- 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*
- 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
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