Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
7 Policies to Address Barriers to the Use of Evidence-Based Nonpharmacological Approaches to Pain Management Highlights â¢ Delivering more effective pain care through the expanded use of nonpharmacological therapies will require policy changes that promote awareness, acceptance, availability, accessibility, and af- fordability (Saper). â¢ Novel systems and tools have been developed to gather evidence regarding multidimensional aspects of patientsâ pain, treatment effects, and patient preferences and expectations, which can in- form efforts to revise policies (Buckenmaier, Darnall). â¢ To change the culture of pain management, educational programs should target not only providers, but patients and payers as well (Bonakdar, Cowan, Darnall). â¢ Flexible policies are needed that allow providers to deliver the right treatments to the right people, and that equip people to self- manage their pain as much as possible without demonizing the need to receive medical treatment, including opioids when appro- priate (Darnall). â¢ Reimbursement reform is needed to address the discordance be- tween evidence-based practices and payment structures, ensure providers have adequate time for a complete pain assessment, and enable clinicians rather than payers to determine optimal treat- ment approaches (Carr, Cowan, Herman). â¢ Large health systems such as the Department of Veterans Affairs (VA) and Kaiser Permanente have successfully implemented complementary nonpharmacological care approaches and can serve as models for other health systems (Goldberg, Lisi). â¢ Patients should be at the center of policy decisions (DeBar, Heapy, Kerns). 63
64 NONPHARMACOLOGICAL APPROACHES TO PAIN MANAGEMENT â¢ Profound differences in the cost of opioids versus nonpharmaco- logical care, along with cultural expectations, evidence, and ease of controlling coverage, are key drivers of coverage disparities; health systems and payers are exploring alternative care, cover- age, and reimbursement models to increase the use of nonphar- macological approaches (Alexander, Elton, Ling, Livingston). NOTE: These points were made by the individual speakers identified above; they are not intended to reflect a consensus among workshop participants. Chapter 6 discussed efforts to address the problem of inadequate pain education through the development of interprofessional curricula. How- ever, inadequate education is but one of many barriers to the delivery of effective pain care (Kligler et al., 2018). To help lower these barriers and accelerate change toward greater use of nonpharmacological therapies, policy changes will be needed as well as evidence to support those policy changes, according to Robert Saper, director of integrative medicine in the Department of Family Medicine at Boston Medical Center and associate professor at the Boston University Schools of Medicine and Public Health. Saper noted that much of the heightened focus on pain management at the policy level has been fueled by the opioid epidemic and its sequelae; for example, policies and regulations that promote medication-assisted treatment ensure the availability of detox facilities, and decrease opioid prescribing. However, he suggested that policies also need to look up- stream at pain itself. BARRIERS AND POTENTIAL OPPORTUNITIES TO THE IMPLEMENTATION OF NONPHARMACOLOGICAL CARE: PATIENT, CLINICIAN, EDUCATOR, AND HEALTH CARE SYSTEM PERSPECTIVES Both barriers and opportunities to implement evidence-based non- pharmacological approaches to pain treatment can be captured by what Saper calls the five As: awareness, acceptance, availability, accessibility, and affordability. Awareness and acceptance are relevant to all stakeholder groups (e.g., patients, providers, educators, health systems, and payers), he said, while availability, accessibility, and affordability are especially
POLICIES TO ADDRESS BARRIERS 65 important to patients, providers, health systems, and payers. While work- shop participants focused their comments on nonpharmacological ap- proaches, some of the issues raised and opportunities discussed may be relevant to all pain management. Improving the Understanding of Pain As mentioned in Chapters 2 and 3, an incomplete understanding of pain hinders the delivery of optimal pain care. To overcome this barrier, Daniel Carr said the first step is to recognize pain, particularly chronic pain, as a disease per se. This would call on the field to raise its evidence base to be comparable with those of other diseases such as cancer and car- diovascular disease, he said. To achieve this, especially in the realm of interventional pain medi- cine, Carr suggested broadening the sources or types of evidence and the manner in which data are analyzed and synthesized. He also called for balancing procedure-centric guidelines with patient-centric guidelines that stratify and prioritize resources for patients at risk. Guidelines, regulations, laws, and regulatory policies should respect the diversity of populations and the variability of individuals and should be consistent with the Na- tional Pain Strategy and the Federal Pain Research Strategy, he said. Fi- nally, Carr suggested revisiting the Centers for Disease Control and Prevention (CDC) guidelines to examine unintended consequences of their implementation and generalization (Carr, 2018). Better data are needed, said Beth Darnall, including better phenotyp- ing and data on treatment effects and patient preferences and expectations. She said there is an imperative to invest in the implementation of learning health care systems; for example, the Stanford Collaborative Health Out- comes Information Registry (CHOIR) provides a platform for pragmatic research and for the implementation of scalable, digital behavioral pain medicine treatments that can be deployed at low or no cost. CHOIR allows providers to track multidimensional aspects of a patientâs pain over time, discuss with patients which symptoms have the most impact, and then en- gage them in different dimensions of treatment. For example, Darnall and her colleagues have developed a perioperative digital behavioral pain med- icine treatment called My Surgical Success to help patients learn how to self-manage pain after surgery. The tools commonly used to assess pain intensity also fail to represent patientsâ experience of pain (Ballantyne and Sullivan, 2015), added Chester (Trip) Buckenmaier. Recognizing this, DVICPM developed a Department
66 NONPHARMACOLOGICAL APPROACHES TO PAIN MANAGEMENT of Defense (DoD) Pain Scale, which retains the 0-to-10 numbering system commonly used, but defines each number with functional language and asks four additional questions to capture the impact of pain on activity, sleep, mood, and stressâaspects of the pain experience that are meaning- ful to patients (Buckenmaier et al., 2013). Buckenmaier said he thinks that by measuring the right factors, treatments such as acupuncture and mas- sage can actually compete with opioids in terms of effectiveness. He added that the DoD has also established the Pain Assessment Screening Tools and Outcomes Registry (PASTOR),1 leveraging both the DoD Pain Scale and the National Institutes of Health (NIH) Patient Reported Outcome Measurement Information System (PROMIS) instruments to collect data and help identify best practices (Cook et al., 2014). Reforming Education and Changing Culture Education gaps regarding pain assessment and pain management were discussed in Chapter 6. Robert Bonakdar, director of pain manage- ment at the Scripps Center for Integrative Medicine, said education reform is needed not only for providers, but for patients and payers as well. He said culture change is also needed. Bonakdar advocated a national educa- tion campaign with clear messaging about the benefits of nonpharmaco- logical interventions. He suggested supporting this with a national clearinghouse of educational materials that are evidence based and shown to have a real-world impact, possibly with case studies. The need for changes in pain education was reiterated by Carr as well as Penney Cowan, founder and chief executive officer of the American Chronic Pain Association. Cowan called for mandatory education in pain management for all health care providers across the board. Carr suggested flipping the pain curriculum from a bottom-up to a top-down approach to change the emphasis from nociceptive mechanisms to social determinants and dimensions of pain (Carr and Bradshaw, 2014). Bonakdar added that education for providers should also be expanded to include courses on nu- trition, prevention, and provider empathy. Darnall said scalable methods need to be developed and applied to improve education for clinicians and patients. By leveraging technology, she suggested that some of the solutions discussed earlier could be applied 1For more information about PASTOR, see https://www.dvcipm.org/clinical- resources/pain-assessment-screening-tool-and-outcomes-registry-pastor (accessed Febru- ary 6, 2019).
POLICIES TO ADDRESS BARRIERS 67 more broadly to achieve both short- and long-term impacts. Darnall also advocated for dedicated funding to scale up matriculation and professional training to meet patient demand. This might involve cross-institutional collaborations as well as community-based professional pain education in- centivized with reimbursement models, she said. Improving Access to Pain Care Through Policy To access a balanced approach to pain management, people with pain need health care that is patient-centered and helps them move from being a passive patient to an active participant, said Cowan. That means includ- ing the patient voice in everything, from bedside to bench or bench to bed- side. Bonakdar also supported the idea raised earlier of using pain navigators or educators to help patients access optimal care. Darnall added that flexible policies are needed that allow providers to deliver the right treatments to the right people, and that equip people to self-manage their pain as much as possible without demonizing the need to receive medical treatment, including opioids when appropriate. Carr agreed, adding that stigmatization and marginalization of patients being treated for pain is a significant barrier to care (Carr, 2016). Reforming Reimbursement Policies Discordance between evidence-based best practices and payment structures, such as inadequate coverage for multidisciplinary therapy in- cluding behavioral therapy and medication-assisted therapy, further hinder delivery of optimal pain care, said Carr. Another way that reimbursement policies block optimal care is by not allowing providers adequate time to do a complete assessment, said Cowan. She called for adequate reimburse- ment of providersâ time to allow for a complete assessment of a personâs pain. Cowan also called for changes in prior authorization for many pain management treatments to allow for more flexible and targeted treatment options. Patricia Herman added that costs to patients extend far beyond copays and reimbursement. There are costs to individuals in terms of taking time off work to visit a practitioner or to receive training for self-care, which then needs to be integrated into daily activities, that need to be considered when revising guidelines, she said. She emphasized that chronic pain is chronic. Some of the course of pain management should be entrusted to
68 NONPHARMACOLOGICAL APPROACHES TO PAIN MANAGEMENT patients and their providers, said Herman, and not prescribed by payer guidelines that might not match patientsâ needs. Cowan suggested changes in policies regarding opioid prescribing that take treatment decisions out of payerâs hands and give that authority back to providers. She added that if a provider is going to stop opioid treatment, the tapering protocol should be designed according to the individual pa- tientâs needs. However, if the patient is functioning well and has a good quality of life, opioids may be a long-term part of their complete pain man- agement, said Cowan. Implementing Integrative Pain Management Harley Goldberg, retired physician executive at the Northern Califor- nia Kaiser Permanente Medical Care Program, shared experiences he had when implementing complementary approaches in a closed health care system that combines both delivery of and payment for services. Evidence of the efficacy of acupuncture did not drive inclusion of the modality into the system, he said. Rather, the health care system agreed to incorporate complementary approaches when presented with usage data showing that a brief acupuncture program of four to six treatments resulted in declined us- age in every single clinical department except for chronic pain. Goldberg added that in a single-payer system like Kaiser, adding clinicians in one area means subtracting them somewhere else, which complicates the im- plementation of a new program. In addition, integrating ancillary providers and adjunctive treatments into the system presents operational challenges, he said. The solution at Kaiser was to build new programs into existing programs, said Goldberg. For example, mindâbody medicine programs were built into their very mature patient education program as well as some psychology, behavioral medicine, and primary care modules, he added. Anthony Lisi, chiropractic program director for the Veterans Health Administration, described some of the VA policy and practice initiatives that have enabled implementation of nonpharmacological painmanage- ment. In 2001, a law2 was passed requiring the VA to begin including chi- ropractic care as a covered service, and in 2004 a directive was issued to start providing chiropractic care in-house at VA facilities as well as in the community. Use of chiropractic services grew slowly at first, but has ac- celerated in recent years. Additionally, in 2014, the VA established the 2PublicLaw 107-35, the Department of Veterans Affairs Health Care Programs Enhancement Act.
POLICIES TO ADDRESS BARRIERS 69 Integrative Health Coordinating Center. The Comprehensive Addiction and Recovery Act of 2016 further mandated expansion within the VA of nonpharmacological approaches, particularly those in the complementary and integrative realms, said Lisi. According to Lisi, there are now approximately 170 chiropractors providing care at 99 VA facilities, and the use of chiropractic care has grown an average of about 18 percent per year since 2005 (Lisi and Brandt, 2016). Within the VA, chiropractic clinics can be implemented in physical medicine and rehabilitation, pain medicine, or primary care, and all three models have worked well, although with different dynamics, he said. Lisi added that chiropractic users in the VA tend to be younger and more likely to be female, which matches the priority population of Iraq and Afghani- stan veterans who, in comparison with veterans of previous wars, are also younger, more likely to be female, and more likely to have chronic mus- culoskeletal pain and mental illness as their main complaints. In 2016, the VA Health Services Research & Development Service held a state-of-the-art conference on nonpharmacological approaches for the management of chronic musculoskeletal pain. Lisi said that among the results of that conference was the recommendation to deliver several non- pharmacological approaches for pain widely within the VA, and specifi- cally to deliver those therapies early in the course of pain care rather than only after other approaches had failed (Kligler et al., 2018). He noted that the recommended approachesâcognitive behavioral therapy (CBT), ac- ceptance and commitment therapy, mindfulness-based stress reduction, physical exercise, tai chi, yoga, acupuncture, manipulation, and mas- sageâwere listed by therapy, not by discipline. In other words, it comes back to putting the patient first as opposed to the provider first, said Lisi. Recently, acupuncture has been offered in the VA, and while previ- ously only physicians and chiropractors with acupuncture training were authorized to provide acupuncture therapy, licensed acupuncturists were recently approved as well. The VA has partnered with DoD to provide battlefield acupuncture training, said Lisi. More than 2,000 VA providers, including physician assistants and nurse practitioners, have since been trained to perform ear acupuncture, which involves inserting small needles at specific points in the ears to relieve pain, said Lisi (Levy et al., 2018). He added that the number of veterans receiving acupuncture increased greatly in recent years. In 2014, Lisi and colleagues assessed the implementation of chiroprac- tic care (Lisi et al., 2014). They identified several barriers and some facil- itators, which he said may be applicable to other services. The three main
70 NONPHARMACOLOGICAL APPROACHES TO PAIN MANAGEMENT barriers were negative perceptions by individual physicians, lack of fund- ing (because the original VA mandate was unfunded), and lack of guid- ance on how to implement the service, said Lisi. Conversely, the strongest facilitator was having a positive perception of individual physicians and decision makers. New funding initiatives and central office guidance have also helped to expand chiropractic care, he said. Interestingly, neither pa- tient preferences nor the degree of evidentiary support was identified as a barrier or facilitator, said Lisi. Along with colleagues at Yale and the Pain Research, Informatics, Multimorbidities and Education (PRIME) Center at the VA Connecticut Healthcare System, Lisi has also examined opioid use among veterans. They found that the percentage of the population likely to fill an opioid prescription was much lower after a chiropractic visit compared with be- fore the visit (Lisi et al., 2018). Placing Patients at the Center of Policy Decisions Lynn DeBar noted that one cannot discuss quality without some kind of patient-centered outcome. Robert Kerns added that the experience of clinicians in health care systems and organizations is also important. Wen Chen from the NCCIH commented about the difficulty for patients to know what to do first. She asked if there is evidence to support recom- mending one approach over another and if not, how researchers might de- sign studies to gather this evidence. Alicia Heapy said she believes there are many different ways for patients to improve. The most important thing, she said, is that patients have the opportunity to engage in treatments and continue receiving that treatment if they believe it is providing benefits. For that to happen, she said, a system is needed that makes it easy for patients to obtain care and for providers to make referrals. Providers need to be educated about the value of providing nonpharmacological treat- ments early, Heapy added. THE PAYER PERSPECTIVE: INSURANCE COVERAGE AND REIMBURSEMENT With public attention focused on both the opioid epidemic and the care of people in pain, policy makers have the unique opportunity to scrutinize the role coverage and reimbursement policies can play in reducing the overuse of opioids and improving quality of care for those in pain, said
POLICIES TO ADDRESS BARRIERS 71 Caleb Alexander, founding co-director of the Center for Drug Safety and Effectiveness and associate professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health. One of the biggest myths about the opioid epidemic is that there is a conflict between these two goals; however, Alexander said there is no conflict. Strengthening coverage, reimbursement, quality, and access to nonpharmacological treatments is the place to start, he said. Eight years ago, DoD published a report that concluded there was good evidence for the use of many nonpharmacological modalities, espe- cially yoga, massage therapy, mindfulness meditation, and tai chi for back pain, in contrast to the use of chronic opioids and highly invasive and po- tentially destructive surgical approaches, said Eric Schoomaker (Office of the Army Surgeon General, 2010). He wondered why coverage of non- pharmacological treatments is still being debated in some circles. One rea- son, said Roger Chou, is that for primary care providers, ordering an imaging test or prescribing an opioid may be easier and take less time. He added that even if physicians want to refer their patients to psychologists, acupuncturists, or other providers of nonpharmacological treatments, they may have difficulty finding a provider who will provide the right treatment and take the patientâs insurance. Moreover, Chou said, there is no system to vet these providers and the paperwork required from Medicaid and other payers may be onerous. Revising Coverage Policies to Improve the Treatment of Pain There are wide disparities among insurers in coverage and adoption of nonpharmacological treatments for pain, said Alexander. Profound differ- ences in cost are one driver of this disparity, he said. Whereas a typical course of physical therapy may call for 6 to 12 visits and a $30 copay per visit (Heyward et al., 2018), the median cost of a 30-day supply of generic opioids is only about $10 (Lin et al., 2018). Costs matter not only to pa- tients, but to policy makers too, said Alexander. In many states, constraints on Medicaid budgets make it extremely difficult for them to add new ben- efits. He added that there have been mixed data regarding the degree to which various treatments pay for themselves. A few years ago, Oregonâs Health Evidence Review Commission identified a problem in the stateâs Medicaid coverage for back pain, said Catherine Livingston, associate medical director of the Commission. Back pain was not a funded diagnosis, said Livingston, which essentially meant that patients could see their primary care providers and get opioids, but no
72 NONPHARMACOLOGICAL APPROACHES TO PAIN MANAGEMENT other treatments were covered. Given the evidence supporting the use of nonpharmacological therapies for back pain, Livingston said they con- vened a public multidisciplinary task force to develop a new back pain coverage paradigm that includes coverage for all the therapies that have been shown to be effective, including CBT, spinal manipulation, acupunc- ture, physical therapy, occupational therapy, nonopioid medications, yoga, interdisciplinary rehabilitation, supervised exercise, and massage. Recog- nizing the likelihood of implementation barriers, she said they added an âif availableâ caveat to the policy. Simultaneously, they created a guide- line to limit the use of treatments that do not have evidence of efficacy (e.g., TENS and epidural steroid injections) or that have evidence of harm, such as opioids.3 They also added a risk stratification component using the STarT Back tool mentioned in Chapters 3 and 4. Livingston said that PCORI and the National Institute on Drug Abuse (NIDA) are studying the impact of this new policy and should have results in a few years. She added that while this was a very expensive change in policy, the Commission believed it was the right thing to do and imple- mented it. Other challenges raised by this policy include workforce issues such as licensing and credentialing; educating providers, patients, and plan medical directors; and implementation issues related to meeting require- ments and tapering opioids, said Livingston. In Chapter 2, David Elton said that when the first point of contact is a chiropractor or physical therapist, opioid use is markedly reduced and sug- gested that substantial savings could be realized if physical therapists and chiropractors replaced primary care providers or specialists as first line providers. He and his colleagues at Optum have shown that for the treat- ment of back pain, the conservative care pathway that begins with chiro- practic, physical therapy, or acupuncture is the most aligned with prevailing pain treatment guidelines and the least fragmented, yet only 30 percent of patients start on this pathway. Meanwhile, he said, only about 2 percent of specialists or medical physicians refer patients to conservative (i.e., low-risk and low-cost) care (see Figure 7-1). Eltonâs group wants to increase the percentage of patients starting with conservative care to more than 50 percent in the next 2 years and at the same time increase the percentage of referrals from physicians to con- servative care to around 10 percent. Actuaries have estimated that this 3For more information, see https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/ Evidence-based-Reports-Blog.aspx?View=%7b2905450B-49B8-4A9B-AF17-5E1E03AB 8B6B%7d&SelectedID=197 (accessed March 12, 2019).
POLICIES TO ADDRESS BARRIERS 73 FIGURE 7-1 Imaging and opioid use for nonsurgical spine episodes. The graph displays the likelihood of receiving an opioid or imaging study at any time during an episode of back pain based on the specialty of the first provider. SOURCE: Presented by David Elton on December 5, 2018. would reduce annual medical expenditures by about $230 million and opi- oid prescribing for back pain by about 25 percent, said Elton. The call to action, he said, is to make this happen now. No more research or data are needed to support this change, Elton said. One way to help achieve this goal, he said, would be to have out-of- pocket costs (i.e., copays and deductibles) for conservative care reduced or eliminated. Providing consumers with tools and resources to help them understand available options based on the characteristics of their pain and their own personal preferences could help guide them toward choosing conservative care when appropriate, or more aggressive care when needed, he said. Reforming Reimbursement Policies Value-based payment reforms through shared savings or bundling may address another barrier to the delivery of quality pain care (i.e., the
74 NONPHARMACOLOGICAL APPROACHES TO PAIN MANAGEMENT concern expressed from clinicians that reimbursement rates are too low), said Julie Fritz. Elton agreed that the rates that are paid to providers of nonpharmacological therapies might not be appropriate for the value cre- ated. Bundling payments for multiple visits over weeks or months is chal- lenging, he said, particularly when multiple providers are involved and/or subcontractors are used for services. Optum has been developing a value- based bundled payment model, said Elton. Shari Ling, deputy chief medi- cal officer for the Centers for Medicare & Medicaid Services (CMS), added that the CMS Innovation Center has also developed several bundled payment care initiative models and is exploring other alternative payment models as well, although no pain-specific model thus far. One possible approach would combine comprehensive primary care with an alternative payment model, she said. DeBar mentioned that there are also many small- scale natural experiments going on at coordinated care organizations to examine how services are organized and whether alternative payment models might result in better patient outcomes. Bonakdar noted that clinicians also must grapple with denial of cov- erage for some nonpharmacological pain therapies such as biofeedback. Elton said the opioid epidemic has forced a lot of innovation and rethink- ing about legacy coverage policies for treatments such as biofeedback. To introduce coverage for a new therapy, payers and health systems need to evaluate the science supporting the approach, how it will be covered, and what the cost will be to cover it, he said. It is a long journey, but a neces- sary one given the urgent need for new approaches to address this epi- demic, said Elton. The Importance of Evidence in Coverage Decisions To implement coverage changes, payers need evidence of the effects on critical outcomes such as long-term function, opioid use, use of emer- gency care, and ability to return to work, said Livingston. Evidence on dose response of nonpharmacological interventions is also important, she added. The importance of evidence was reiterated by Ling. When it comes to coverage determinations for Medicare, one of the major limitations has been the absence of evidence from patient samples that reflect the Medi- care beneficiary population, she said. This explains, for example, why there is a national noncoverage policy for acupuncture. She acknowledged, however, that the constraint in enrolling Medicare patients in clinical trials
POLICIES TO ADDRESS BARRIERS 75 stems from the Medicare statute. Strategies are needed to integrate these patients into trials, said Ling. Ling added that as CMS shifts from volume to value in considering how and what services to cover, having a core set of outcomes that matter to the people served would be incredibly helpful. Moreover, she said, the metrics and data collected across care settings (e.g., clinicians, practices, health systems, programs, states, the entire country) all need to be stand- ardized and aligned. She noted that this is already taking place as a result of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act).4 Coverage is just the starting point, said Ling, adding that barriers to implementation also need to be identified and addressed. Among these are administrative barriers, which are being addressed in part through the Patients over Paperwork Initiative, launched by CMS Admin- istrator Seema Verma in October 2017.5 4To learn more about the IMPACT Act, see https://www.cms.gov/Medicare/Quality- Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act -of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting-Measures.html (ac- cessed February 6, 2019). 5To learn more about the Patients Over Paperwork Initiative, see https://www.cms.gov/ About-CMS/story-page/patients-over-paperwork.html (accessed February 6, 2019).