Pain Management Inter-Agency Task Force: September 2018 Meeting Materials – Draft Gaps and Recommendations

Pain Management Inter-Agency Task Force: September 2018 Meeting Materials – Draft Gaps and Recommendations

Chronic pain affects an estimated 50 million U.S. adults or approximately 20 percent of the population.As many as 19.6 million U.S. adults experience high-impact chronic pain, which is defined as pain occurring and interfering with life or work activities most days or every day.Pain can be a symptom of an injury or surgery, but also can be a disease either primary or secondary.

The Pain Management Best Practices Inter-Agency Task Force (Task Force) is determining whether there are gaps or inconsistencies between best practices for pain management, and developed draft recommendations that address gaps or inconsistencies of existing clinical best practices for managing acute and chronic pain.Within the draft document, the word “gap” is used to mean the following: gap, inconsistency, update and/or re-emphasis of vital best practices.These draft recommendations are intended to support the clinical judgment of health care providers and to encourage a balanced, patient-centered approach to pain management using a variety of multi-modal techniques. The Task Force voted on the intent of the draft recommendations to be included in a draft report.

The draft report, that will be published in the Federal Register in November 2018, will include proposed updates and draft recommendations. The public will have an opportunity to comment on the draft report during a 90 day public comment period as required under Section 101 of the Comprehensive Addiction and Recovery Act of 2016 (P.L. 114-198).

Note:Readers should not consider these draft recommendations as guidance or instruction regarding the diagnosis, care or treatment of acute or chronic pain or to supersede in any way existing guidance.

Information in the draft recommendations do not necessarily reflect the opinions of the U.S. Department of Health and Human Services or any other component of the federal government.

Sections:

• 1. Gaps and Recommendations
  • 1.1 Clinical Best Practices
    • 1.1.1 Approaches to Pain Management
    • 1.1.2 Medication
    • 1.1.3 Physical Therapy
    • 1.1.4 Interventional Procedures
    • 1.1.5 Special Populations
    • 1.1.6 Psychological Approaches
  • 1.2 Cross-Cutting Clinical and Policy Best Practices
    • 1.2.1 Risk Assessment
    • 1.2.2 Stigma
    • 1.2.3 Complementary, Alternative and Integrative Therapies (CAIT)
    • 1.2.4 Education
    • 1.2.5 Access to Pain Care
  • 1.3 Review of CDC Guidelines

1.  Gaps and Recommendations

1.1  Clinical Best Practices

1.1.1  Approaches to Pain Management

Gap 1: Current inconsistencies and fragmentation of pain care limit best practices and patient outcomes. A coherent policy for pain management within health systems is needed.

• Recommendation 1: Encourage coordinated and collaborative care that allows for best practices and improved patient outcomes whenever possible. One of many examples is the collaborative stepped model of pain care, as adopted by the Department of Veteran Affairs (VA) and the Department of Defense (DoD) Health Systems.

Acute Pain

Gap 1: Multimodal non-opioid therapies are underutilized in the perioperative setting.

• Recommendation 1a: Utilize procedure-specific, multimodal regimens and therapies when indicated in the perioperative period, including various non-opioid medications, ultrasound-guided nerve blocks, analgesia techniques (e.g., lidocaine and ketamine infusions), and psychological and integrative therapies to mitigate opioid exposure.
• Recommendation 1b: Utilize multidisciplinary and multimodal approaches for perioperative pain control (e.g., joint camps, Enhanced Recovery After Surgery [ERAS], Perioperative Surgical Home [PSH]). Key components may include pre-operative psychology screening and monitoring; pre-operative and post-operative consultation and planning for managing moderate to severe complexity; preventive analgesia with preemptive analgesic non-opioid medications; and regional anesthesia techniques such as continuous catheter local anesthetic infusion.
• Recommendation 1c: Develop appropriate reimbursement and authorization policies to allow for a multimodal approach to acute pain in the perioperative setting and the peri-injury setting, including pre-operative consultation to determine a multimodal plan for the perioperative setting.

Gap 2: Guidelines for the use of multimodal clinical management of the acute pain associated with common categories of surgical interventions and trauma care are needed.

• Recommendation 2a: Develop acute pain management guidelines for common surgical procedures and trauma management, carefully considering how these guidelines can serve both to improve clinical outcomes, as well as to avoid unintended negative consequences.
• Recommendation 2b: Emphasize the following in guidelines, which provide an initial pathway to facilitate clinical decision-making:
  • Individualized treatment as the primary goal of acute pain management accounting for patient variability with regard to factors such as co-morbidities, severity of conditions, surgical variability, geographic considerations, and community/hospital resources.
  • Improved pain control, faster recovery, improved rehabilitation with earlier mobilization, less risk for blood clots and pulmonary embolus, and mitigation of excess opioid exposure.

1.1.2  Medication

Gap 1: Clinical policies tend to treat the large population of patients with multiple different conditions causing chronic pain with simple medication rules. Guidelines for medication use for specific populations of patients (e.g., different ages, sex, medical conditions, co-morbidities) with chronic pain need to be developed for each specialty group and setting.

• Recommendation 1a: Develop condition-specific treatment algorithms that guide physicians to have a more individualized approach for common pain syndromes and conditions. A multidisciplinary approach that integrates the biopsychosocial model is recommended.
• Recommendation 1b: Primary care and non-pain specialists should have timely, early consultation with pain medicine and other specialists for the assessment of patients with complex pain to prevent complications, loss of function, and to improve quality of life.
• Recommendation 1c: Develop a collaborative multimodal treatment plan between the referring physician, the pain medicine team, and the patient.
• Recommendation 1d: Pharmacies should collaborate with area physicians and other healthcare providers to develop more effective and patient-friendly delivery systems to meet the needs of their patients.

Gap 2: Opioids are often used early in pain treatment. There has been minimal pain education in medical school and residency programs, and little guidance for primary care physicians on appropriate pain treatment approaches.

• Recommendation 2a: Use of non-opioid medications (e.g., oral and IV acetaminophen, oral and IV NSAIDs, long-acting local anesthetics, dexmedetomidine), along with non-pharmacologic treatments, should be utilized as first-line therapy whenever possible in the in-patient and out-patient settings.
• Recommendation 2b: If an opioid is being considered, physicians and other healthcare providers should utilize evidence-informed guidelines.
• Recommendation 2c: The type, dose, and duration of opioid therapy should be determined by treating physicians according to the individual patient’s need and pain condition.
• Recommendation 2d: Opioid therapy should only be initiated along with ongoing non-opioid treatments when the benefits outweigh the risks; the patient is experiencing severe acute or chronic pain that interferes with function; and the patient is willing to continue to engage with the team on a comprehensive multidisciplinary treatment plan, as clinically indicated, with established clear and measurable treatment goals, along with close follow-up and regular risk assessment and re-evaluation.
• Recommendation 2e: CMS and payors should provide reimbursement that aligns with the medication guidelines the Pain Management Task Force has described.

Gap 3: There is often a lack of understanding and education regarding the clinical indication and effective use of non-opioid medications as part of a multimodal and multidisciplinary approach to acute and chronic pain management. Chronic pain is often ineffectively managed, which can be due in part to a variety of factors including physician training, patient access, and other barriers to care.

• Recommendation 3a: Physicians and other healthcare providers should understand the use of non-opioid medication and their mechanism-based pharmacology for managing different components of pain syndromes.
• Recommendation 3b: For neuropathic pain: Consider anti-neuropathic medication including tricyclic antidepressants (TCAs), anticonvulsants (e.g., gabapentin, pregabalin, carbamazepine, Oxycarbazepine), serotonin and norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine, venlafaxine), and topical analgesics such as lidocaine and capsaicin. Regardless of the route of medication, education regarding the side effects and risks and benefits is vital in terms of understanding clinical indications and patient outcomes.
• Recommendation 3c: For non-neuropathic non-cancer pain: Use Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and acetaminophen as first-line classes of medications following standard dosing schedules. Further classes of medication depend on the patient’s response and can include – depending on specific pain syndromes – an indication for muscle relaxants (e.g., tizanidine, baclofen) and topical agents in addition to other multimodal approaches. Additional consideration should be given to SNRIs indicated for chronic musculoskeletal pain.

Gap 4: Barriers, such as lack of coverage and reimbursement and understanding of proper usage, limit access to buprenorphine treatment for chronic pain.

• Recommendation 4a: Make buprenorphine treatment for chronic pain available for specific groups of patients and include oral buprenorphine for third-party payors with hospital formularies.
• Recommendation 4b: Provide coverage and reimbursement for buprenorphine treatment approaches.

Gap 5: There is currently inadequate education for patients regarding safe medication storage and appropriate disposal of excess medications, targeted at reducing outstanding supplies of opioids that might be misused by others, or inadvertently accessed by children and other vulnerable members of the household.

• Recommendation 5a: Increase public awareness of poison center services as a resource that provides educational outreach programs and materials, referral to treatment facilities, links to take-back facilities, and resources for safe drug storage, labeling, and disposal.
• Recommendation 5b: The U.S. Drug Enforcement Agency (DEA) should increase opportunities for safe drug disposal and drug disposal sites (i.e., pharmacies, police departments, fire departments).
• Recommendation 5c: Adopt neutralization technologies that may make safe disposal more readily available.
• Recommendation 5d: Include partial fills of C-2 drug classes.
• Recommendation 5e: Educate veterinarians on the importance of safe storage and disposal of opioid medications in their practice. Additionally, educate pet owners about the importance of safe storage and disposal of opioid pain medication prescribed for their pets.

Overdose Prevention Education and Naloxone

Gap 1: Bystander/take-home naloxone distribution is associated with a cost-effective reduction in mortality as well as improved connection to opioid-use disorder; however, distribution is not widely available.

• Recommendation 1a: Provide naloxone co-prescription/dispensing and education for patients and family members when the patient is on long-term opioids.
• Recommendation 1b: Increase naloxone distribution programs and education for first responders.
• Recommendation 1c: Research the potential risks and benefits of over-the-counter available naloxone.

1.1.3  Physical Therapy

Gap 1: There is a lack of clarity on which Physical Therapy (PT) modalities are indicated in the various pain syndromes.

• Recommendation 1a: Conduct further research to provide evidence-informed data on which PT modalities are indicated as part of a multidisciplinary approach to specific pain syndromes.
• Recommendation 1b: For those modalities where there are clear indications for benefits in the treatment of chronic pain syndromes (e.g., OT/PT, aqua therapy, Transcutaneous Electrical Nerve Stimulation (TENS), and movement-based modalities including tai chi, Pilates, yoga), there should be minimal barriers to access these modalities as part of a recommended multidisciplinary approach to the specific pain condition.
• Recommendation 1c: Make harm-free, self-administered therapies, such as TENS, freely available to support pain management treatment plans.

1.1.4  Interventional Procedures

Gap 1: Interventional pain procedures can provide diagnostic information when evaluating patients in pain, as well as provide therapeutic pain relief. A comprehensive assessment by a skilled pain specialist needs to be available to assess which particular procedure is indicated for a patient’s pain syndrome. Unfortunately, pain physician specialists are typically not involved in the multidisciplinary approaches of treating a pain patient early enough in their treatment. This can lead to suboptimal patient outcomes.

• Recommendation 1a: Adopt well-researched interventional pain guidelines to guide the appropriate use of interventional pain procedures as a component of a multidisciplinary approach to the pain patient. Guidelines are particularly important for guiding the collaboration of primary care and pain medicine.
• Recommendation 1b: Conduct additional clinical research that establishes how interventions work in conjunction with other approaches in the process of caring for chronic pain patients, especially early in the process when combined appropriately with goal-directed rehabilitation therapy and appropriate medications.
• Recommendation 1c: Establish criteria-based guidelines for properly credentialing physicians who are appropriately trained and are utilizing interventional techniques to help diagnose, treat, and manage patients with chronic pain.

Gap 2: There is inconsistency and frequent delay in insurance coverage for interventional pain techniques that are clinically appropriate for a particular condition and context.

• Recommendation 2a: Provide consistent and timely insurance coverage for evidence-informed interventional procedures early in the course of treatment when clinically appropriate. These may be paired with medication and other therapies to improve function and quality of life.
• Recommendation 2b: Restore reimbursement to non-hospital sites of service to improve access and lower cost of interventional procedures.

Gap 3: There is a trend of inadequately trained physicians and non-physicians performing interventional procedures. This can potentially lead to serious complications and inappropriate utilization. Outside of the Accreditation Council for Graduate Medical Education (ACGME) accredited residency and fellowship programs, there is currently little to no oversight regarding training requirements for interventional procedures.

• Recommendation 3a: Establish credentialing criteria for minimum requirements for the training of physicians in interventional pain management.
• Recommendation 3b: Only physicians who are credentialed in interventional pain procedures should perform interventional procedures.
• Recommendation 3c: Clearly identify physicians who are specialized in pain management by their training. This should be determined by ACGME accredited pain medicine programs and by well-recognized credentials, such as the American Board of Pain Medicine and the American Board of Interventional Pain Physicians.

Perioperative Management of Chronic Pain Patients

Gap 1: Chronic pain patients undergoing a surgical procedure often have complex issues that go unaddressed that may lead to incomplete and poor care.

• Recommendation 1: The perioperative team should be consulted to form a treatment plan that addresses the various aspects that would be necessary for best outcomes in this pain population.

1.1.5  Special Populations

Unique Issues Related to Pediatric Pain Management

Gap 1: The significant shortage of pediatric pain specialists and comprehensive pain service centers presents a barrier in addressing the needs of pediatric acute and chronic pain patients and their medical issues. This limited access is further compromised by lack of reimbursement and coverage for services related to comprehensive pain management, including non-pharmacologic evidence-based pain therapies.

• Recommendation 1a: Increase access to pediatric pain services with pain expertise, which can likely be achieved through an increase in the workforce and novel care delivery models.
• Recommendation 1b: Deliver and appropriately reimburse/cover pediatric pain care in the context of comprehensive multidisciplinary treatment.

Gap 2: Pediatric patients with chronic pain conditions eventually transition to adult care, during which patients may experience gaps in care, increased healthcare utilization, poor patient outcomes, and other healthcare vulnerabilities and morbidities.

• Recommendation 2: Develop models of care for appropriate transition for pediatric patients with acute and chronic pain conditions to ensure seamless care delivery as well as decreased morbidity and mortality.

Gap 3: Most pain physician specialists are not credentialed in pediatric pain, and therefore, not permitted by their institutions to take care of children with chronic pain.

• Recommendation 3: Encourage and assist pain physicians in obtaining the necessary training for credentialing in pediatric pain. This is a significant step toward improving pediatric patient access.

Gap 4: Many current clinical best practices do not address pediatric opioid prescribing best practices. Further, there is a lack of RCTs or RWE (real-world evidence) investigating non-opioid pharmacologic therapies in pediatric patients for chronic pain.

• Recommendation 4a: Develop pediatric pain management guidelines addressing appropriate indications for opioids and responsible opioid prescribing.
• Recommendation 4b: Conduct pediatric pain research to inform national guidelines utilizing multimodal approaches to optimize pediatric pain management for children and adolescents.

Geriatric Patients

Gap 1: There is a lack of opioid-prescribing guidelines for the aging population given their increased risk of falls, cognitive decline, respiratory depression, and renal impairment.

• Recommendation 1a: Develop pain management guidelines for older adults that address their unique risk factors.
• Recommendation 1b: Utilize a multidisciplinary approach with non-pharmacologic emphasis given the increased risk of medication side effects in this population.
• Recommendation 1c: Establish appropriate pain management education for physicians and other healthcare providers treating older adults.

Pregnancy

Gap 1: There is a need for evidence-based clinical practice guidelines for the use of analgesics during pregnancy and the postpartum period.

• Recommendation 1a: Develop pain management guidelines for pregnant and postpartum women in collaboration with the national specialty societies (The American College of Obstetricians and Gynecologists (ACOG), neonatologists, obstetricians, perinatal pediatricians, and other specialists).
• Recommendation 1b: Counsel women of childbearing age on the risks of opioids and other medications in pregnancy, including risks to the fetus and neonate.

Sickle Cell Disease

Gap 1: There is a lack of evidence-based management guidelines for the treatment of acute and chronic pain for children and adults with sickle cell disease.

• Recommendation 1a: Develop comprehensive, evidence-based guidelines for the treatment of acute and chronic sickle cell disease pain for children and adults.
• Recommendation 1b: Conduct research targeted at non-opioid pharmacologic therapies and non-pharmacologic approaches for sickle cell disease pain management.

Gap 2: Unpredictable episodic exacerbations of acute pain pose a challenge for sickle cell disease pain management, and the majority of patients have failed non-opioid pain drugs prior to presentation for acute care. Constraints on opioid treatment duration can be restrictive for individualization of pain management. Further, limited access to oral opioids at home for the treatment of unplanned acute painful events can result in increased utilization of healthcare services that could have been avoided.

• Recommendation 2a: Protect access to the appropriate and safe use of opioids for patients with sickle cell disease, with consideration for exemption from prescribing guidelines and state prescribing laws that do not specifically address patients with sickle cell disease due to the complex nature and mechanism of acute and chronic sickle cell pain.
• Recommendation 2b: Consider the lowest effective dose of opioids to treat acute pain crises and prescribe within the context of close follow-up and comprehensive outpatient pain care.
• Recommendation 2c: Develop an individualized approach to pain management that includes consideration of opioid and non-opioid therapies, such as behavioral health strategies and multimodal approaches.
• Recommendation 2d: Provide patient education on the risks and benefits of opioids.

Gap 3: The sickle cell patient population faces significant healthcare disparities that impact access to, and delivery of, comprehensive pain care and mental health services. Further, stigma, negative provider attitudes, and perceived racial bias may possibly be associated with sickle cell disease pain, which may compromise care, thus leading to increased suffering from pain and pain care delivery.

• Recommendation 3a: Develop comprehensive care delivery models for sickle cell disease pain management, including collaborative partnerships between pain medicine and hematology.
• Recommendation 3b: Develop outpatient infusion clinics/day hospitals for sickle cell disease pain management to decrease reliance on the emergency department for pain treatment.
• Recommendation 3c: Increase access to, and reimbursement for, mental health services for patients with sickle cell disease.
• Recommendation 3d: Provide education focused on stigma, negative provider attitudes, and perceived racial bias at all levels of healthcare to optimize delivery of pain treatment to patients with sickle cell disease.

Other Chronic Relapsing Pain Conditions

Gap 1: There is often a lack of partnership between the disease specialist (i.e., the hematologist, oncologist, rheumatologist, or neurologist) and providers of comprehensive multidisciplinary pain programs.

• Recommendation 1: Provide referrals to a comprehensive pain program early in the course of the chronic disease (e.g., multiple sclerosis, cancer, porphyria, systemic lupus erythematosus, migraine, Parkinson’s disease, neuropathic pain syndromes) to determine the optimal approach to managing acute or chronic pain exacerbations, including potential non-opioid alternative therapies and non-pharmacologic therapies. Establish a partnership between the disease specialist (i.e., the hematologist, oncologist, neurologist, or rheumatologist) and the pain team to optimize care.

Unique Issues Related to Pain Management in Women

Gap 1: Women face unique challenges regarding their physical and mental health, interactions with the healthcare system, and roles in society. Women use the healthcare system as patients, caregivers, and family representatives, and can be particularly affected by costs, access issues, and gender insensitivity of healthcare providers and staff. A number of diseases associated with pain, and in particular, chronic high-impact pain, have a higher prevalence in women or are sex-specific, including endometriosis, musculoskeletal and orofacial pain, fibromyalgia, migraines, and abdominal and pelvic pain.

• Recommendation 1a: Increase research to elucidate further understanding of the mechanisms driving sex differences in pain responses and research of mechanism-based therapies that address those differences.
• Recommendation 1b: Raise awareness in the public and healthcare arenas to the unique challenges that women face during pregnancy and the postpartum period, including various pain syndromes and psychosocial co-morbidities.

Gap 2: Women may experience increased pain sensitivity. Of note, Obstetrician-Gynecologists may be one of the first healthcare providers a woman with pain encounters, yet they are not often included as part of a multidisciplinary care team.

• Recommendation 2: Include Obstetrician-Gynecologists as part of multidisciplinary care teams, as they are likely to play an important role in the treatment of pain for women.

Health Disparities in African Americans, Latinos, American Indians, and Alaska Natives

Gap 1: Socioeconomic and cultural barriers may impede patient access to effective multidisciplinary care. There is evidence of racial and ethnic disparities in pain treatment and treatment outcomes in the U.S., yet few interventions have been designed to address these disparities. Lower quality pain care may be related to many factors, including barriers to accessing healthcare, lack of insurance, discrimination, lack of a primary care provider, lack of childcare, lower likelihood to be screened or receive treatment, and environmental barriers that impede self-management.

• Recommendation 1: Develop intervention programs informed by the biopsychosocial model to reduce racial and ethnic disparities in pain.

Gap 2: Research shows that ethnic minorities may have greater pain sensitivity and are at increased risk for chronic pain, yet they are underserved.

• Recommendation 2: Develop biopsychosocial interventions for pain that are scalable and culturally enhanced.

Veterans

Gap 1: Military active service members and Veterans have unique physical and mental health challenges related to their military service that contribute to the development, or exacerbate, acute and chronic pain conditions. Medical and mental health comorbidities such as traumatic brain injury, post-traumatic stress disorder, limb loss, and musculoskeletal injuries often interfere with successful treatment outcomes. Assessment and treatment of pain conditions in active duty service members and Veterans requires military specific expertise and a coordinated, collaborative approach between medical and mental health providers.

• Recommendation 1a: Physicians and other healthcare providers taking care of military active duty service members, regardless of practice setting, should consider in their pain care plan prior military history and service-connected health factors that may contribute to acute or chronic pain, as relevant to the clinical presentation.
• Recommendation 1b: Physicians and other healthcare providers should work collaboratively to deliver comprehensive pain care that is consistent with the biopsychosocial model of pain.
• Recommendation 1c: Conduct research to better understand the biopsychosocial factors contributing to acute and chronic pain in active duty service members and Veterans, with a focus on traumatic-brain injury, PTSD, and other mental health and substance-use
• Recommendation 1d: Conduct studies to better understand the contributing factors predisposing these patients toward movement along the spectrum from acute pain to persistent pain.

Gap 2: The transition of active duty military service members to Veteran status can be complicated. A multitude of factors that may affect a successful transition includes, but are not limited to, incomplete integration of electronic health records and imposed changes and/or delays in access to primary care, pain specialty, and mental health physicians and other healthcare providers.

• Recommendation 2: The integration of DoD and VHA healthcare systems is important for effective and timely pain care. This integration should include coordination of the transition from active duty to Veteran status and care coordination across the healthcare spectrum that includes a smooth transition to primary care, mental health and pain specialty physicians, and other healthcare providers.

Gap 3: Active duty military service members and Veterans increasingly receive care in the community (including care provided through external payment systems and DoD/VHA purchased care). A fragmented healthcare system results in lack of coordination of care provided in the community, within the Military Health System, and in the VHA, and differing care standards (such as the implementation of opioid risk mitigation strategies). Within VHA, access to primary care and specialty care, in particular, multidisciplinary pain specialty care, is difficult for some Veterans due to geographical factors, limited availability of providers, and the need for specialized pain care treatment.

• Recommendation 3: In order to improve care coordination across healthcare systems, streamlined access to medical records and collaboration across systems are needed to provide more timely and effective pain care.

1.1.6  Psychological Approaches

Access to Psychological Interventions

Gap 1: Access to evidence-based psychological and behavioral health approaches for treating chronic pain and mental health co-morbidities (e.g., Post-traumatic stress disorder [PTSD], depression, anxiety, mood disorders, substance use disorders) is limited due to geography, reimbursement, and education in primary care and specialty care settings.

• Recommendation 1a. Increase access to evidence-based psychological interventions through alternative treatment delivery (e.g., telehealth, internet self-management, group, telephone counseling) and hub-and-spoke models.
• Recommendation 1b: Educate physicians and other healthcare providers on the benefits of psychological and behavioral health treatment modalities in the multidisciplinary approach to acute and chronic pain management.
• Recommendation 1c. Improve reimbursement policies for integrated, multidisciplinary, multimodal treatment approaches that include psychological and behavioral health interventions through traditional and non-traditional delivery methods.

Chronic Pain Patients with Mental Health and Substance Use Co-Morbidities

Gap 1. Clinical best practices for chronic pain do not adequately address how to treat individuals with co-morbid psychological health concerns.

• Recommendation 1a. Screen for psychological health and substance use disorders in acute and chronic pain management patients and consider early referral to psychologists or psychiatrists who have expertise in pain.
• Recommendation 1b. Use an integrated multidisciplinary approach that may include existing evidence-based psychological and behavioral interventions (g., cognitive behavioral therapy, coping skills, stress-reduction, mindfulness-oriented recovery) to address complex chronic pain patients.
• Recommendation 1c: Referral to both pain and addiction specialists when opioid-use disorder is suspected.
• Recommendation 1d: When opioids are indicated for someone with a history of opioid-use disorder (e.g., post-operative injury or cancer), clinicians should use the lowest effective dose in conjunction with non-opioid treatment modalities with enhanced monitoring and collaboration with addiction specialists. Conduct regular re-evaluation and assessment with a treatment plan and established goals in order to achieve optimal patient outcomes.

Gap 2. Many clinical best practices for chronic pain do not adequately address barriers to acceptance of psychological treatments.

• Recommendation 2: Enhance and inform patient, clinician, and public understanding of the importance of a biopsychosocial model approach for certain chronic pain conditions.

Gap 3: Research gaps exist on the effectiveness of existing psychological interventions for the treatment of psychological health and substance use in the subpopulation of patients with chronic pain and psychological health co-morbidities.

• Recommendation 3a: Conduct research on the applications and indications of existing evidence-based psychological health interventions for chronic pain patients with psychological health and/or substance use co-morbidities.
• Recommendation 3b: Conduct research on the efficacy of novel and promising psychological and behavioral health treatments (e.g., biofeedback, hypnosis, relaxation therapies, meditation, tai chi).

Gap 4: There has not been sufficient validation of mobile and electronic health applications (apps) used for clinical treatment of pain patients with co-morbid psychological conditions.

• Recommendation 4a: Conduct peer-reviewed validation research to guide the use of mobile and electronic (e-) health applications within the context of the biopsychosocial treatment modalities for chronic pain.
• Recommendation 4b: Add a category for e- and mobile treatments to the Substance Abuse and Mental Health Services Administration (SAMHSA) evidence-based practices resource center, and a designation for pain for target audiences when evidence of benefit exists.
• Recommendation 4c: Establish a validation process for apps used for biopsychosocial treatments to better inform physician, provider, and patient users of these apps that are evidence-based and effective for the management of various chronic pain syndromes.

1.2  Cross-Cutting Clinical and Policy Best Practices

1.2.1  Risk Assessment

Screening and Monitoring

Gap 1: Comprehensive screening and risk assessment of patients is time-consuming but vital for proper evaluation of their chronic pain conditions. Lack of sufficient compensation for time and payment for services has contributed to barriers in best practices for opioid therapy.

• Recommendation 1a: Provide sufficient compensation for time and payment for services to implement the various screening measures (e.g., extensive history taking, review of medical records, PDMP query, urine toxicology screenings). These are vital aspects of risk assessment and stratification for patients on opioids and other medications.
• Recommendation 1b: Consider referral to pain and/or other specialists when high-risk patients are identified.

Gap 2: Urine drug tests (UDTs) are not consistently utilized as part of the routine risk assessment for patients on opioids.

• Recommendation 2a: Use UDTs as part of the risk assessment tools prior to initiation of opioid therapy, and as a tool for re-evaluating risk, using the clinical judgment of the treatment team.
• Recommendation 2b: Physicians and other healthcare providers should educate patients on the use of UDTs and its role in identifying both potential inappropriate use and appropriate use.

Gap 3: There is variability in what is included in opioid treatment and/or opioid agreements.

• Recommendation 3a: Conduct studies to evaluate the effectiveness of the different components of opioid treatment agreements. Treatment agreements should include the responsibilities of both the patient and the provider.
• Recommendation 3b: Use opioid treatment discussions as an educational tool between providers and patients to inform the risks and benefits of, and alternatives to, chronic opioid therapy.

Prescription Drug Monitoring Programs (PDMPs)

Gap 1: PDMP use varies greatly across the U.S., with variability in PDMP design, the state’s health IT infrastructure, and current regulations on prescriber registration, access, and use.

• Recommendation 1a: Check PDMPs, in conjunction with other risk stratification tools, upon initiation of opioid therapy with periodic re-evaluation.
• Recommendation 1b: Provide physician and provider training on accessing and interpreting PDMP data.
• Recommendation 1c: Physicians and other healthcare providers should engage patients to discuss their PDMP data rather than making a judgment that may result in the patient not receiving appropriate care. PDMP data alone is not errorproof and should not be used to dismiss patients from clinical practices.
• Recommendation 1d: The healthcare provider team should determine when to use PDMP data. This should not be mandated without proper clinical indications to avoid unnecessary burden in the inpatient
• Recommendation 1e: Conduct studies to better identify where the use of PDMP data is best utilized (inpatient versus outpatient settings). Adjust PDMP data use based on the findings of the recommended studies. This can minimize undue burdens and overutilization of resources, e., streamline PDMP data use.
• Recommendation 1f: Electronic Health Records (EHRs) should work to integrate PDMPs in their system design at minimal to no additional cost to providers (to eliminate barriers to accessing PDMP data), especially when these data points are mandated.
• Recommendation 1g: Enhance interoperability of PDMPs across state lines to allow for more effective usage.
• Recommendation 1h: Physicians and other healthcare providers within, as well as outside, federal healthcare entities should have access to each other’s data to ensure safe continuity of care.
• Recommendation 1i: Include all opioid prescribers including physician and non-physician providers and dentists in PDMPs.

1.2.2  Stigma

Gap 1: Chronic pain patients may face barriers in access to pain care due to being stigmatized as people seeking medications to misuse. Contributing to this stigmatization are the lack of objective biomarkers for pain, the invisible nature of the disease, and societal attitudes that equate acknowledging pain as weakness.

• Recommendation 1a: Increase patient, physician and other healthcare providers, and societal education around the underlying disease process of acute and chronic pain in order to reduce stigma.
• Recommendation 1b: Increase patient, physician and other healthcare providers, and societal education around the disease of addiction.
• Recommendation 1c: Counter societal attitudes equating pain and weakness through an awareness campaign that urges early treatment for pain that persists beyond the expected duration for that condition or injury.
• Recommendation 1d: Encourage research aimed at discovering biomarkers for chronic pain neurobiological mechanisms.

Gap 2: The national crisis of illicit drug use along with overdose deaths are confused with the appropriate therapy of patients who are being treated for pain. This confusion has created a stigma that contributes to barriers to proper access to care.

• Recommendation 2: Identify strategies to reduce stigma in opioid use so that it is never a barrier for patients receiving appropriate treatment with all cautions and considerations for the management of their chronic pain conditions.

1.2.3  Complementary, Alternative and Integrative Therapies (CAIT)

Gap 1: There is a large variety of Complementary, Alternative and Integrative Therapies (CAIT) that remain unknown to the broader medical community and that are often overlooked in the management of pain.

• Recommendation 1a: Consider CAIT therapies including, but not limited to, acupuncture, mindfulness meditation, movement therapy, art therapy, massage therapy, manipulative therapy, spirituality, yoga, and tai chi, in the treatment of acute and chronic pain when indicated.
• Recommendation 1b: Develop clinical practice guidelines for the application of CAIT for specific indications.

Gap 2: There is a gap in the understanding of CAIT therapies in terms of mechanisms of action, clinical studies examining the feasibility of integrating CAIT into current care models, the efficacy of individual CAIT therapies in special populations, and clinical evaluation of CAIT therapies in the perioperative surgical period as part of a multimodal approach to acute and chronic pain settings.

• Recommendation 2a: Conduct further research to determine therapeutic value, risk and benefits, mechanisms of action, and economic contribution to the treatment of various pain settings, including the acute perioperative surgical pain period and various other chronic pain conditions and syndromes.
• Recommendation 2b: Consider the inclusion of various CAIT treatments as part of an integrated approach to the treatment of chronic pain, as clinically indicated, while evidence is further developed.
• Recommendation 2c: Conduct further research on supplements such as alpha lipoic acid, L-carnitine transferase, and vitamin C, and their effect on acute and chronic pain management.

1.2.4  Education

Public Education

Gap 1: National public education about pain is needed.

• Recommendation 1a: Develop a national evidence-based pain awareness campaign that emphasizes the public’s understanding of acute and chronic pain syndromes.
• Recommendation 1b: Establish a mechanism to finance a large-scale, systematic, coordinated public campaign to address pain awareness.

Patient Education

Gap 1: Current pain patient education is lacking in both acute and chronic pain.

• Recommendation 1a: Prioritize time and patient access to educational tools that include, but are not limited to, clinician visits, patient handouts, web resources, and support groups to optimize patient outcomes.
• Recommendation 1b: Explore and test innovative methods of delivering patient education and support for acute and chronic pain patients using technology, particularly in rural areas that have little access to multimodal treatment. Examples of means to provide patient access in such situations include telemedicine, the Project Extension for Community Healthcare Outcomes (ECHO) hub-and-spoke model, online support groups, networks of in-person support groups with training and guidance of leaders, and applications easily accessible via mobile phones.

Gap 2: Patient expectations regarding the management of their pain in the perioperative arena are frequently not aligned with current surgical practices or procedures that require pain management.

• Recommendation 2a: Emphasize discussions about pain control after surgery during the pre-operative visit. This should be done by both the surgical and pre-operative team.
• Recommendation 2b: For major surgeries, use models such as the perioperative surgical home (PSH) or ERAS protocols to emphasize the importance of patient education and management.
• Recommendation 2c: CMS and other payors should recognize that the time spent to educate and manage patients’ expectations provides a significant value that reduces the length of hospital stay and improves their postoperative pain management, allowing for faster recovery through earlier PT and mobility that decreases the risk for post-operative complications (e.g., blood clots). CMS and other payors should compensate accordingly to physician-patient time spent.

Gap 3: Current chronic pain patient educational materials and interventions lack consistency, standardization, and comprehensive information.

• Recommendation 3a: Establish an online resource of evidence-informed educational materials for common pain conditions and appropriate treatment modalities.
• Recommendation 3b: Convene a chronic pain expert panel including experienced patients, patient advocates, and clinicians to develop a set of core competencies and other essential information specific to patient pain education. Provide grants for the creation of patient education programs and materials based on these core competencies and disseminate widely to patients and their families and caregivers through clinics, hospitals, pain centers, and patient groups.

Physician and Other Healthcare Provider Education

Gap 1: There are gaps in pain management understanding and education throughout the medical school curriculum, graduate medical education, residency training, as well as all levels of other healthcare providers’ training and education.

• Recommendation 1a: Incorporate further development of a biopsychosocial education model for physicians and other healthcare providers at all levels of training.
• Recommendation 1b: Develop effective educational resources for primary care providers to improve the current understanding and knowledge of pain treatment modalities, initially available treatments, and early referral to pain specialists.
• Recommendation 1c: Explore intensive continuing pain education for primary care providers. This includes, but is not limited to, telehealth, telementoring, and the Project ECHO model, as a means to provide pain education for primary care providers by pain specialists. Consider the State Targeted Response-Technical Assistance (STR-TA) model for pain training as it currently exists for addiction training.

Gap 2: Pain is generally treated as a symptom of other illness, disease, or injury, and not commonly recognized as a separate category of disease. The lack of education regarding pain syndromes and pain mechanisms limits the ability to recognize chronic pain as a category of diseases.

• Recommendation 2a: Recognize chronic pain as a category of diseases when the pain persists for more than the expected recovery time (3-6 months) despite appropriate treatment of the original inciting injury or disease.
• Recommendation 2b: Conduct further education regarding pain syndromes and mechanisms through physician and other healthcare provider training, such as continuing medical education (CME), the ECHO model, telementoring, and other continuing education programs.

1.2.5  Access to Pain Care

Medication Shortage

Gap 1: Recurrent shortages in opioid and non-opioid medications have created barriers to the proper continuity of treatment in acute and chronic pain patients. This creates the unintended consequence of poor patient care.

• Recommendation 1a: The FDA should monitor, report, and prioritize the availability of key opioid and non-opioid medications, including injectables such as local anesthetics that can adversely affect patient pain care.
• Recommendation 1b: The FDA should make available alternative sources for these medications when critical shortages occur (e.g., stop-gap measures such as obtaining these medications from other countries, compound pharmacies).
• Recommendation 1c: Support the Drug Shortage Task Force in its endeavors to find solutions to the critical challenges of drug shortages.

Insurance Coverage for Complex Management Situations

Gap 1: Time and resources are not sufficient for complex and safe opioid management.

• Recommendation 1a: Reimburse complex opioid and non-opioid management consistent with time and resources required for patient education, safe evaluation, risk assessment, re-evaluation, and integration of alternative non-opioid modalities.
• Recommendation 1b: CMS and private payors should investigate and implement innovative payment models that recognize and reimburse holistic, integrated multimodal pain management, including, but not limited to, CAIT.

Gap 2: Payor guidelines are outdated and not in sync with the current medical and clinical guidelines.

• Recommendation 2: CMS and other payors should align their reimbursement guidelines for acute and chronic multidisciplinary pain management with current clinical practice guidelines (CPGs).

Gap 3: Payors often do not reimburse for non-opioid pharmacologic therapies that are more expensive than opioids.

• Recommendation 3: CMS and other payors should align their reimbursement guidelines for non-opioid pharmacological therapies with current CPGs.

Gap 4: Coordinated, individualized, multidisciplinary care for chronic pain management is a best practice and has been shown to result in better and more cost-effective outcomes, yet this model of care is nearly impossible to achieve with current payment models.

• Recommendation 4: Payors should reimburse pain management using a chronic disease management model. CMS and private payors should reimburse integrative, multidisciplinary pain care using a chronic disease management model in the manner that they currently reimburse cardiac rehabilitation and diabetes chronic care management programs. Additionally, reimburse care team leaders for time spent coordinating patient care.

Workforce

Gap 1: There is a lack of multidisciplinary physicians and other healthcare providers who specialize in pain. These physicians and other healthcare providers include pain specialists, addiction psychiatrists, psychologists, pharmacists, and others who are trained to be a part of the pain management team.

• Recommendation 1a: Enhance the physician and other healthcare provider pain management specialty workforce training in treating chronic pain with psychological co-morbidities. This should include improved curriculum training in residency, fellowship, CME courses, and other continuing education modules that help improve patients’ understanding and engagement in psychological treatment.
• Recommendation 1b: Expand graduate medical residency positions to train in pain specialties including adult pain specialists, pediatric pain specialists, behavioral health providers, pain psychologists, and addiction psychiatrists.
• Recommendation 1c: Expand availability of non-physician specialists including, but not limited to, physical therapists, psychologists, and behavioral health specialists.

Research

Gap 1: Lack of incentives for innovations in the treatment of chronic and acute pain hinder the advancement of treatment.

• Recommendation 1: Increase Federal (and state) funding through the National Institutes of Health (NIH), DoD, and other agencies to support and accelerate basic science, translational, and clinical research of pain. Allocate funding to develop innovative therapies and to build research capabilities for better clinical outcomes tracking and evidence gathering.

Gap 2: Genetic and experiential factors in the progression of pain are not clearly understood.

• Recommendation 2: Improve understanding of the specific interplay of genetic and experiential contributions to pain including identification of biomarkers, factors that play a role in persistent pain and eventually chronic pain, the role of co-morbid conditions, and predictive risk factors.

Gap 3: There is a lack of understanding of contributing factors that predispose certain patients to substance use disorders and addiction.

• Recommendation 3a: Further evaluate lifelong risk factors for the development of substance use disorders rather than isolated evaluation of prescription opioid use (e.g., adolescent substance use, early life trauma).
• Recommendation 3b: Conduct research to identify biomarkers, genetic predisposition, and other patient factors to assist in improved and accurate identification of those patients at risk for substance abuse disorders and addiction disease.

Gap 4: There is a lack of research and funding in potentially innovative modes of delivery and treatment.

• Recommendation 4: Increase the levels of research on novel strategies that target the underlying mechanisms of chronic pain. This includes, but is not limited to, pharmacologic and biologic research and development, medical devices, new and innovative technological advancements, medication delivery systems, neuro-modulation, regenerative medicine, and Complementary, Alternative and Integrative Therapies (CAIT), as well as movement-based modalities.

1.3  Review of CDC Guidelines

Gap 1: There is an absence of high-quality data on the duration of opioid effectiveness for chronic pain, which has been interpreted as a lack of benefit.

• Recommendation 1a: Support studies to determine the long-term efficacy of opioids in the treatment of chronic pain syndromes (primary and secondary) in different populations determined by clinical context, clinical conditions, and co-morbidities.
• Recommendation 1b: Conduct clinical trials on specific disease entities with a focus on patient variability and their response to tissue injury and in the effectiveness of opioid analgesics. Design trials to be applicable in real-world settings (e.g., patients receiving trialed opioid medications while maintaining the usual multimodal therapy).

Gap 2: There is an absence of criteria for identifying the subpopulation of patients for whom opioids comprise a significant part of pain management.

• Recommendation 2: Conduct clinical studies or complete systematic reviews to identify which subpopulations of patients with different chronic pain conditions may be appropriate for long-term opioid treatment in conjunction with the various non-opioid modalities.

Gap 3: There is wide variation in factors that affect the determination of the optimal dose of opioids.

• Recommendation 3a: Consider patient variables that may affect opioid dose in patients prior to initiation of opioid therapy, including, but not limited to, respiratory compromise or impaired metabolism that could affect plasma opioid
• Recommendation 3b: Perform comprehensive initial assessments for patient management with an understanding of the need for periodic re-evaluation to adjust the medication dose.
• Recommendation 3c: Careful consideration should be given to patients on an opioid pain regimen with additional risk factors for opioid-use

Gap 4: Specific guidelines addressing opioid tapering and escalation are lacking.

• Recommendation 4a: Undertake opioid tapering or escalation with a thorough assessment of the risk-benefit ratio. This should be done in collaboration with the patient whenever possible.
• Recommendation 4b: Develop guidelines for tapering and dose escalation for subpopulations of patients with chronic pain conditions that includes consideration of their co-morbidities.
• Recommendation 4c: Consider maintaining therapy for patients who are stable on long-term opioid therapy and for whom the benefits outweigh the risks.

Gap 5: There are multiple potential causes of worsening of pain that are often not recognized or considered. Non-tolerance related factors include iatrogenic causes including surgery, flares of the underlying disease/injury, and increased ergonomic demands and/or emotional distress (e.g., anxiety disorders, catastrophizing, depression).

• Recommendation 5a: Once a stable dose is established for at least two months, avoid increases in dose until the patient is re-evaluated for the underlying causes of elevated
• Recommendation 5b: Evaluation for non-tolerance concerns should include opioid rotation, non-opioid medications, interventional strategies, cognitive behavioral strategies, Complementary, Alternative and Integrative Therapies (CAIT), and physical therapy.

Gap 6: Although the risk of overdose by benzodiazepine co-prescription with opioids is well established, this combination may still have clinical value in patients with chronic pain and co-morbid anxiety, which commonly accompanies pain, and in patients with chronic pain and spasticity.

• Recommendation 6a: If clinically indicated, co-prescription should be managed and coordinated by physicians, providers, and clinician specialists with knowledge, training, and experience in co-prescribing benzodiazepines with opioids. For those patients with anxiety disorders or substance abuse disorders who have been prescribed benzodiazepines, collaboration with experts in mental health and the use of psychological modalities should be considered.
• Recommendation 6b: Develop clinical practice guidelines that also focus on tapering for co-prescription of benzodiazepines and opioids.

Gap 7: The risk-benefit balance for opioid management may vary for individual patients. Similarly, the balance of benefit and risk for doses above 90 Morphine Milligram Equivalents (MME)/day may be favorable to some patients, while doses below 90 MME/day may be a greater risk due to individual patient factors. The variability in effectiveness and safety of low doses of opioids and the variability in effectiveness and safety of high doses of opioids are not clearly defined.

• Recommendation 7a: Use the lowest effective opioid dose that balances benefits, risks, and adverse reactions. Physicians and other healthcare providers should individualize dose based on a carefully monitored medication trial by the patient, with frequent monitoring of analgesic effectiveness with each dose adjustment and with regular risk re-assessment.
• Recommendation 7b: Discourage the use of arbitrarily defined MME and daily dosing limits on chronic pain management, and utilize established and measurable goals such as functionality, Activities of Daily Living (ADL), and quality of life (QOL) measures.

Gap 8: The duration of pain following an acute severely painful event such as trauma, surgery or burn is widely variable.

• Recommendation 8a: Appropriate duration of therapy is best determined by the treating physician. The CDC recommendation for duration of treatment should be removed in future revisions of the CDC Guidelines.
• Recommendation 8b: Develop acute pain management guidelines for common surgical procedures and trauma management, as noted in Acute Pain Recommendation 2a.
• Recommendation 8c: In order to both address this variability and provide an easy solution to the challenges of medication duration, consideration should be given to a partial refill system.