Chapter 6 discussed efforts to address the problem of inadequate pain education through the development of interprofessional curricula. However, 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 upstream 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 nonpharmacological 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
important to patients, providers, health systems, and payers. While workshop participants focused their comments on nonpharmacological approaches, 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 cardiovascular disease, he said.
To achieve this, especially in the realm of interventional pain medicine, 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 National Pain Strategy and the Federal Pain Research Strategy, he said. Finally, 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 phenotyping 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 Outcomes 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 patient’s pain over time, discuss with patients which symptoms have the most impact, and then engage them in different dimensions of treatment. For example, Darnall and her colleagues have developed a perioperative digital behavioral pain medicine 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 patients’ experience of pain (Ballantyne and Sullivan, 2015), added Chester (Trip) Buckenmaier. Recognizing this, DVICPM developed a Department
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 stress—aspects of the pain experience that are meaningful to patients (Buckenmaier et al., 2013). Buckenmaier said he thinks that by measuring the right factors, treatments such as acupuncture and massage 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 management 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 education campaign with clear messaging about the benefits of nonpharmacological 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 nutrition, 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
1 For more information about PASTOR, see https://www.dvcipm.org/clinical-resources/pain-assessment-screening-tool-and-outcomes-registry-pastor (accessed February 6, 2019).
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 incentivized 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 including the patient voice in everything, from bedside to bench or bench to bedside. 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 including 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 reimbursement of providers’ time to allow for a complete assessment of a person’s 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
patients and their providers, said Herman, and not prescribed by payer guidelines that might not match patients’ needs.
Cowan suggested changes in policies regarding opioid prescribing that take treatment decisions out of payer’s 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 patient’s 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 management, said Cowan.
Implementing Integrative Pain Management
Harley Goldberg, retired physician executive at the Northern California 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 usage 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 implementation 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, mind–body 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 painmanagement. In 2001, a law2 was passed requiring the VA to begin including chiropractic 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 accelerated in recent years. Additionally, in 2014, the VA established the
2 Public Law 107-35, the Department of Veterans Affairs Health Care Programs Enhancement Act.
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 Afghanistan veterans who, in comparison with veterans of previous wars, are also younger, more likely to be female, and more likely to have chronic musculoskeletal 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 nonpharmacological approaches for pain widely within the VA, and specifically 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 approaches—cognitive behavioral therapy (CBT), acceptance and commitment therapy, mindfulness-based stress reduction, physical exercise, tai chi, yoga, acupuncture, manipulation, and massage—were 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 previously 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 chiropractic care (Lisi et al., 2014). They identified several barriers and some facilitators, which he said may be applicable to other services. The three main
barriers were negative perceptions by individual physicians, lack of funding (because the original VA mandate was unfunded), and lack of guidance 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 patient 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 before 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 recommending one approach over another and if not, how researchers might design 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 treatments early, Heapy added.
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
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, especially yoga, massage therapy, mindfulness meditation, and tai chi for back pain, in contrast to the use of chronic opioids and highly invasive and potentially destructive surgical approaches, said Eric Schoomaker (Office of the Army Surgeon General, 2010). He wondered why coverage of nonpharmacological treatments is still being debated in some circles. One reason, 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 patient’s 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 differences 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 patients, but to policy makers too, said Alexander. In many states, constraints on Medicaid budgets make it extremely difficult for them to add new benefits. He added that there have been mixed data regarding the degree to which various treatments pay for themselves.
A few years ago, Oregon’s Health Evidence Review Commission identified a problem in the state’s 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
other treatments were covered. Given the evidence supporting the use of nonpharmacological therapies for back pain, Livingston said they convened 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, acupuncture, physical therapy, occupational therapy, nonopioid medications, yoga, interdisciplinary rehabilitation, supervised exercise, and massage. Recognizing the likelihood of implementation barriers, she said they added an “if available” caveat to the policy. Simultaneously, they created a guideline 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 implemented 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 requirements 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 suggested 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 treatment of back pain, the conservative care pathway that begins with chiropractic, 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).
Elton’s 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 conservative care to around 10 percent. Actuaries have estimated that this
3 For more information, see https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports-Blog.aspx?View=%7b2905450B-49B8-4A9B-AF17-5E1E03AB8B6B%7d&SelectedID=197 (accessed March 12, 2019).
would reduce annual medical expenditures by about $230 million and opioid 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
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 created. Bundling payments for multiple visits over weeks or months is challenging, 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 medical 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 coverage for some nonpharmacological pain therapies such as biofeedback. Elton said the opioid epidemic has forced a lot of innovation and rethinking 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 necessary one given the urgent need for new approaches to address this epidemic, 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 emergency 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 Medicare 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
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 standardized 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 Administrator Seema Verma in October 2017.5
4 To 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 (accessed February 6, 2019).
5 To 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).
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