Background

Pain is a monumental public health challenge in the United States, affecting millions of adults, and leading to disability. Conservative estimates suggest costs of $560–635 billion annually.¹ Low back and neck pain accounted for the highest healthcare spending in 2016 across 154 conditions.² Low back pain prevalence estimates in elderly adults range from 21 percent to 75 percent.³ Estimates of chronic pain and high impact chronic pain (i.e., chronic pain that frequently limits life or work activities) prevalence in adults 65 to 84 years of age were 27.6 percent and 10.7 percent respectively, based on 2016 National Health Interview Survey Data.⁴ Estimates of acute pain in those 65 years and older range from 7 to 52 percent, varying by site with headache, joint, and neuropathic pain most commonly cited.⁵ Opioids are frequently prescribed for acute and chronic pain but there is concern about the safety and efficacy of opioid management of pain. In adults 65 years and older, there were substantial increases in opioid-related hospitalizations (34%) and emergency department visits (74%) between 2010 and 2015,⁶ and a 53 percent increase in the proportion of older adults seeking treatment for opioid use disorder from 2013 to 2015.⁷ Across a sample of 1,776,790 Medicare enrollees under 65 years old who qualified for Medicare secondary to disability, 38.5 percent had a pain diagnosis. In the sample, opioid overdose deaths increased from 57.4 per 100,000 in 2012 to 77.6 per 100,000 in 2016.⁸

Pain is complex. It substantially impacts physical and mental function and is influenced by multiple factors (e.g., genetic, central nervous system, psychological, and environmental) and individual characteristics (e.g., age, sex, presence of comorbidities, and psychosocial factors). Such factors impact a person’s pain experience and are collectively considered as part of a variety of biopsychosocial models of pain.^9–12 Understanding how these factors impact pain is important for informing optimal approaches to management. The National Academy of Sciences workshop on Non-Pharmacological Approaches to Pain Management,¹³ the recent Pain Management Best Practices Inter-Agency Task Force report,¹⁴ the National Pain Strategy (NPS) report,¹⁵ and others recommend that optimal pain management be integrated, multi-modal, interdisciplinary, evidence-based, and individualized in keeping with the biopsychosocial model of pain. In keeping with this model, primary components of care may include medication management (e.g., oral pain medications, topical products), physical activity to promote and maintain functional capacity and decrease pain (e.g., movement and body awareness strategies), and pain psychology support (e.g., methods to develop and improve pain management skills such as cognitive behavioral therapy, relaxation, mindfulness-based stress reduction). In addition to these primary components, complementary and integrative health modalities (e.g., acupuncture, massage, spinal manipulation), patient education (e.g., understanding pain, life-style modification, implementation of self-management tools), and other treatments (e.g., physical modalities, injections, surgical procedures) may be part of pain management. Individual patients’ need for and success with any given component or set of components may vary and patients likely benefit most from incorporation of multiple methods of pain management combined versus relying on one specific treatment to manage pain. Delivery of these diverse components requires involvement of professionals from multiple disciplines and, ideally, integration, communication, and coordination of care across these disciplines to outline the most appropriate care pathway(s) for a given patient,^1,15–18 taking into account individual susceptibility and treatment responses.

There is substantial heterogeneity in the terminology used in the literature and in clinical practice to describe and categorize pain management programs that address a biopsychosocial pain model. There is not a standardized set of terms, program definitions, or categorizations for pain management programs. For purposes of this review we conceptualized pain management programs that potentially address care consistent with a biopsychosocial model into two general categories – integrated pain management programs (IPMPs), centered in, and integrated with primary care which have embedded or easy access to multidisciplinary providers and services; and comprehensive pain management programs (CPMPs), not centered in primary care but based on referral from primary care or other sources (e.g., insurance) to a set of multidisciplinary services separate from the primary care environment. Thus, these programs are different regarding where care is delivered and how it is coordinated. The U.S. Department of Veterans Affairs (VA) Whole Health System is an example of an integrated program for chronic pain management.^19–21 A stepped care model is used which involves primary care delivered using Patient Aligned Clinical Teams (PACTs)²¹ and provides a basis for patient assessment, medication management and referral to a range of multidisciplinary providers and services (e.g., behavioral pain management) and for advanced diagnostics and interventions as needed. Traditional multidisciplinary or interdisciplinary rehabilitation programs are examples of CPMPs. Both IPMPs and CPMPs usually include access to appropriate medication and/or a medication management component as well as psychological care (pain psychology and mental health support), and physical rehabilitative methods such as physical therapy or occupational therapy and have some mechanism of care coordination or formal communication between multidisciplinary providers. Both IPMPs and CPMPs may incorporate patient education and self-management components as well as various individual complementary and integrative health therapies (e.g., acupuncture). Integrative pain management differs from integrated pain management programs. Integrative management takes a holistic, person-centered approach to patient care as do the individual complementary and integrative health therapies employed. Integrative pain management generally focuses on a broader range of integrative therapies and practices (e.g., manipulation, mindfulness, acupuncture, massage, mind-body therapies, nutritional counseling, etc.) than integrated pain management programs. Such therapies may be part of formal programs or models that are coordinated by integrative health clinicians and may include consultation with allopathic providers.²² As with IPMPs and CPMPs, integrative pain management may incorporate providers from multiple disciplines. Unless such formal integrative programs also met our definitions for IPMP, they were excluded from this review. IPMPs and CPMPs that included individual integrative therapies in addition to the primary components of psychological care and physical rehabilitative methods and/or medication management were included in this review.

Given the high prevalence of pain in older adults eligible for Medicare and those under 65 years old who qualify for Medicare due to disability, use of effective, safe, and cost-effective pain management becomes imperative. Unique challenges in assessing and managing pain in older adults^5,23 include age-related changes in pain perception and thresholds and responses to medication, comorbidities (medical and psychological), polypharmacy, psychosocial concerns, and lack of care coordination. Older adults may also be predisposed to transitioning from acute to chronic, persistent pain.^24,25 Thus, an integrated, coordinated, and individualized approach may be particularly important in the Medicare population to assure optimal pain management.

The U.S. Department of Health and Human Services has been directed to evaluate ways to improve Medicare coverage and payment for treatment of acute and chronic pain, particularly through integrated pain management programs and multidisciplinary, multimodal treatment models that involve care coordination. Requisite to addressing this decisional dilemma is understanding the types/components and methods of care delivery as well as benefits, potential risks and costs related to such programs for Medicare Parts A and B beneficiaries with complex acute/subacute pain or chronic nonactive cancer pain.

Purpose and Scope of the Systematic Review

This systematic review evaluated the effectiveness and harms of pain management programs and described contextual, process and structural factors that may impact outcomes particularly in the Medicare population. The intended audiences for this review were the Centers for Medicare & Medicaid Services (CMS) and other stakeholders including clinicians, policymakers, patients, their caregivers, and researchers. This review is part of the Dr. Todd Graham Pain Management Study and was sponsored by CMS.