Integrative Health Inclusion in HHS’ DRAFT Report on Pain Management Practices: Tips for Public Response

Integrative Health Inclusion in HHS’ DRAFT Report on Pain Management Practices: Tips for Public Response

The January 2019 newsletter from the Integrative Health Policy Consortium (IHPC) led off with a call to action. A 90 day comment period is open on the new HHS Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies and Recommendations. I read the document with an eye to its inclusion of “complementary”, “integrative”, and “non-pharmacologic”approaches (including a 3-page section on “Complementary and Integrative Health”)  and any specific reference to related practices and practitioners. The document offers remarkable signs both of how far these have penetrated pain policy strategy and of their absence in key action steps. Changes in these would be optimal for the final report. This article is a guide to inclusion and offers suggestions for how the integrative health community might register comments to advance best practices in pain treatment that will help get the opioid money off our collective backs. Public comments are due March 28, 2019.

The Task Force

The policy guidance and recommendations were developed by a 29 member Pain Management Best Practices Inter-Agency Task Force that was created through the 2016 Comprehensive Addiction and Recovery Act (CARA). The description of membership stakeholders includes medicine, behavioral health, substance abuse, advocacy, addiction, and more. The list doesn’t specifically call for complementary or integrative health experts. A cursory review of the 29 suggests that they got what they conceived: no members is principally associated with the integrative health and medicine field. The closest may be Rollin M. Gallagher, MD, MPH whose leadership of various pain related initiatives at the Veterans Administration placed him in that robust integrative activity. The take home point: all that follows – and there is a great deal of inclusion – came without any integrative health ringers on the Task Force sounding the bell for integrative health research and potential contributions.

The Task Force’s ongoing job is to “determine whether gaps in or inconsistencies between best practices for acute and chronic pain management exist and to propose updates and recommendations to those best practices.” This article begins with a few quick comments then collects all of the direct inclusion language in the 51 page document to which in some cases notes are added that could be useful in fashioning comments.

Overall Comments

The first response from this sinular focus – with an eye backward on the evolution of integration – is that the document is remarkable for the level of inclusion. This follows a positive pattern of increasing recognition of complementary and integrative approaches and practitioners in multiple guidelines and policy documents.

The report includes a focused segment on “Complementary and Integrative Health” (pages 33-35). I have included it in full, below. My suggestions there focus on the recommendations rather than the content. Integrator readers may be particularly drawn to that.

Major areas of concern are in the areas of education and research. This document does not see lack of education in the public or among providers to integrative and complementary options as a barrier to best practices.  The research segments do not focus enough on supporting examinations of real world pilots, such as the state of Vermont undertook with acupuncture which was grossly under-funded for the questions the legislators asked. Perhaps more federal-state funding partnerships.

Another area that merits close examination and further recommendations relates to access and insurance coverage. The most significant barrier to referral to acupuncturists, massage therapists, and other practitioners of non-pharmacologic approaches is the reluctance of conventional practitioners to send patients for care for which they must pay out of pocket. While the idea of onsite, multi-modal, integrative pain treatment facilities for all who are in need may be an aspirational goal, for the multitudes for many years to come their best access will be through community practitioners. The Task Force needs help in this area – a gap that perhaps is there because the membership had the gap of no community-based integrative experts.

Below are details on inclusion, with additional notes on possible recommendations in italic.

Integrative, Complementary and Non-Pharmacologic in the Report

What follows is pulled from the 51 page body of the text. It focuses on areas of inclusion – which noting some significant gaps. It does not even reference a majority of the sections. Note that the page numbers are from the pdf of the Draft Report, here.

Overview

A portion of the 1.5 page Overview of the report urges “Clinical Best Practices” under 5 subheadings. One: “Restorative movement therapies. Physical and occupational therapy, massage therapy, aqua therapy.” Another subheading: “Complementary and integrative health. Acupuncture, yoga, tai chi, meditation.”

Notes: Notably absent is chiropractic. A separate line on behavioral interventions stuck to cognitive behavioral and did not explicitly include any mind-body methods beyond that. There is some mention of these elsewhere, below. These might be elevated.

Introduction

“The Task Force recognizes that comprehensive pain management often requires the work of various health care professionals, including physicians, dentists, nurses, pharmacists, physical therapists, occupational therapists, behavioral health specialists, psychologists, and integrative health practitioners.” (5)

“In 2018, the Task Force convened two public meetings that included extensive public comment and critical patient testimonials from various different patient groups. There were numerous subcommittee meeting deliberations and discussions that included various special population presentations, including the Indian Health Services (IHS), the Defense Health Agency, the VA, state health officials, private and industry experts, and integrative pain experts.” (6)

“Gaps and recommendations in the report span five major interdisciplinary treatment modalities: medication, restorative therapies, interventional procedures, behavioral health approaches, and complementary and integrative health.” (6)

Note: The inclusion is good and clarity about what “integrative health practitioners” are would be useful. The term is still not widely understood. A segment on “Access to care” (including insurance coverage) does not directly note the problems in accessing complementary and integrative health services. It says that access “is vital through improved health care coverage for various treatment modalities and an enlarged workforce of pain specialists and behavioral health clinicians to help guide and support appropriately trained primary care clinicians.” This is a gap in the document – a pattern of failing to include integrative in their advocacy. Perhaps, for instance, insert [and integrative health practitioners] after “behavioral health clinicians.”

Section 2. Clinical Best Practices

“Several recent [clinical practice guidelines-CPGs] for chronic pain management agree on specific recommendations for mitigating opioid-related risk through risk assessment, including screening for risks such as depression, active or prior history of SUDs, family history of SUD, and childhood trauma, among other issues, prior to initiating opioids; medication dosing thresholds; consideration of drug-drug interactions, with specific medications and drug-disease interactions; risk assessment and mitigation (e.g., patient-provider treatment agreements); drug screening/testing; prescription drug monitoring programs; and access to nonpharmacologic treatments.” (6)

Note: They note an issue in guidelines of “3) applicability (i.e., likely barriers and facilitators to implementation of the guideline, strategies to improve its uptake, and resource implications of applying it).” (7) While this positively underscores the barrier, complementary and integrative are not mentioned in this context. Nor are these mentioned in another area relative to need for research. Clearly, a great deal of research on how to implement new types of complementary and integrative practitioners and approaches is critical.

“2.1 Approaches to Pain. Recommendation 1a: 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 VA and DoD health systems.”

Notes: While this is not a direct reference to integrative, it is notable that the reference is to a model from two systems with the highest level of integrative health inclusion in the US, the DoD and VA. This is a sign of the (soft) technology transfer from military to civilian medicine that is under way. A general note: this section begins with medications with non pharma and others following. One could recommend that the non-pharma be considered first, as it is in the CDC and other guidelines – to implant the thought pattern.

“2.3 Restorative Therapies. Restorative therapies include physical therapy (PT), occupational therapy (OT), physiotherapy, therapeutic exercise, and other movement modalities that are provided as a component of interdisciplinary, multimodal pain care.(20)  …  Use of restorative therapies is often challenged by incomplete or inconsistent reimbursement policies. (20) … Includes massage: Massage therapy can be effective in reducing pain. There are a variety of types of massage therapy, including Swedish, shiatsu, and deep tissue (myofascial release). In Swedish massage, the therapist uses long strokes, kneading, and deep circular movements. Shiatsu massage uses the fingers, thumbs, and palm to apply pressure. Deep tissue massage focuses on myofascial trigger points, with attention on the deeper layers of tissues.”

  • “Recommendation 1a: Conduct further research to provide evidence-informed data on which restorative therapy 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; TENS; movement-based modalities, including tai chi, Pilates, and yoga), there should be minimal barriers to accessing these modalities as part of a recommended multidisciplinary approach to the specific pain condition.” (22)

Notes: The concept of “restorative therapies” is a good one. This basket should be much broader. An early, widely used definition of naturopathic medicine’s eclectic mix of approaches was that naturopathic doctors “treat disease by restoring health.” Is acupuncture not restorative? Stress reduction technique? The absence of chiropractic here is also notable. This area of the document could stand the insertion of multiple other types of practitioners. The authors are largely working in a limited PT/OT framework. This section could use attention.

“2.4 Interventional Procedures. “Trigger points are palpable, tense bands of skeletal muscle fibers that, upon compression, are capable of producing both local and referred pain. Using either dry needling or injections of local anesthesia, trigger points can be disrupted, resulting in relaxation and lengthening of the muscle fiber, thereby providing pain relief. Trigger point injections can be used therapeutically to treat pain associated with headaches, myofascial pain syndrome, and low-back pain. Other types of direct injections include intramuscular, intrabursal, and intra-articular injections for muscle pain, bursitis, and joint pain, respectively. (24)

Notes: The interprofessional battles between PTs and acupuncturists rage, yet if “dry-needling” makes the grade, “acupuncture” likely merits mention here. Also, the recommendations in this area note that multiple types of practitioners are using injections – and there are recommendations that only “credentialed” practitioners be allowed to perform them (26). Language that does not overly narrow the sets of practitioners who can become credentialed would keep doors open. Many naturopathic physicians are using injections in their pain treatment.

“2.5 Behavioral Health Approaches – as part of pain management are to be considered as a key component of the biopsychosocial model and multidisciplinary pain management.” This section highlights cognitive behavioral therapy and also includes multiple integrative approaches:

“Mindfulness-based stress reduction (MBSR) is a mind-body treatment developed by Jon Kabat-Zinn typically delivered in a group format that focuses on improving patients’ awareness and acceptance of their physical and psychological experiences through intensive training in mindfulness meditation.276 Mindfulness meditation teaches patients to self-regulate their pain and pain-related comorbidities by developing nonjudgmental awareness and acceptance of present moment sensations, emotions, and thoughts. Research suggests that MBSR is an effective intervention for helping individuals cope with a variety of pain conditions, including rheumatoid arthritis, low-back pain, and MS. MBSR has a positive impact on pain intensity sleep quality, fatigue, and overall physical functioning and well-being.” (27)

This is followed by a section on “Self-regulatory or psychophysiological approaches” in which multiple integrative approaches aer mentioned including: biofeedback, relaxation training and hypnotherapy:

“Biofeedback entails monitoring and providing real-time feedback about physiologic functions associated with the pain experience (e.g., heart rate, muscle tension, skin conductance). The overall goal of biofeedback is to improve awareness and voluntary control over bodily reactions associated with pain exacerbations. The use of biofeedback training has been shown effective for chronic headache and migraine in adults and children. Relaxation training and hypnotherapy involve altering attentional processes and heightening the experience of physical and psychological relaxation. Relaxation training is often used in conjunction with biofeedback to increase physiological awareness and enhance relaxation skills. Both of these approaches have empirical support in pain management.  Empirical evidence also provides support for the use of hypnotherapy for pain management for cancer pain, low-back pain, arthritis, pain from SCD, TMJ pain, fibromyalgia, and other pain conditions. Similar to relaxation training, hypnotherapy induces an altered state of consciousness guided by a hypnotherapist that focuses the individual’s attention to alter his or her experience of pain.” (28)

“2.5.2. Chronic Pain Patients with Mental Health and Substance Use Comorbidities.” In this section, under Gap #3 in research evidence there is a 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). (30)

“2.6 Complementary and Integrative Health” (31-33)

“CBPs [Clinical Best Practices] generally recommend a collaborative, multimodal, multidisciplinary, patient-centered approach to treatment for various acute and chronic pain conditions to achieve optimal patient outcomes. Clinicians are encouraged to consider and prioritize, when clinically indicated, nonpharmacologic approaches to the management of pain. Complementary and integrative health approaches for the treatment or management of pain conditions consist of a wide variety of interventions, including mind-body behavioral interventions, acupuncture and massage, osteopathic and chiropractic manipulation, meditative movement therapies (e.g., yoga, tai chi), and natural products, among others. The National Institutes of Health (NIH) National Center for Complementary and Integrative Health defines “complementary approaches” as those nonmainstream practices that are used together with traditional medicine, and defines “alternative approaches” as those used in place of conventional medicine, noting that most patients who use nonmainstream approaches do so with conventional treatments. There are many definitions of “integrative” health care, but all involve bringing conventional approaches, as well as complementary and integrative health approaches together in a coordinated way.

“The current opioid crisis has spurred intense interest in identifying effective nonpharmacologic approaches to managing pain. The use of complementary and integrative health approaches for pain has grown within care settings across the United States over the past decades. As with other treatment modalities, complementary and integrative health approaches can be used as stand-alone interventions or as part of a multidisciplinary approach, as clinically indicated and based on patient status. Examples of complementary and integrative health approaches to pain include acupuncture, hands-on manipulative techniques (e.g., osteopathic or chiropractic manipulation, massage therapy), mindfulness, yoga, tai chi, biofeedback, art and music therapy, spirituality, and the use of natural or nutritional supplements. These therapies can be provided or overseen by licensed professionals and trained instructors. The use of complementary and integrative health approaches should be communicated to the pain management team.

“Overall, most complementary and integrative health approaches can provide improved relief, when clinically indicated, when used alone or in combination with conventional therapies, such as medications, behavioral therapies, and interventional treatments, although more research and evidence-informed studies are necessary.

“Improved reimbursement policies for complementary and integrative health approaches as well as improved education for medical professionals and a greater workforce of pain management specialists can address key barriers to acceptance and implementation of complementary and integrative health approaches for pain. Additional research, greater patient and clinician education — including clinical guidance and indications for use — and expanded coverage of complementary and integrative health approaches are essential for a comprehensive solution to reduce the reliance on opioids.

“The following paragraphs briefly describe complementary and integrative health approaches, which can be considered singularly or as part of a multimodal approach to the management of chronic and acute pain, depending on the patient and his or her medical conditions. This list is not inclusive or exhaustive; rather, it provides just a few examples of common complementary and integrative health approaches.

“Acupuncture is a recognized form of therapy that has its origins in ancient Chinese medicine. It involves manipulating a system of meridians where “life energy” flows by inserting needles into identified acupuncture points. An estimated 3 million American adults receive acupuncture each year. Acupuncture is generally considered safe when performed by a licensed, experienced, well-trained practitioner using sterile needles, although there are risks as with any intervention. The therapeutic value of acupuncture in the treatment of various pain conditions, including osteoarthritis; migraine headaches; and low-back, neck, and knee pain has growing evidence in the form of systematic reviews and meta-analyses. Existing CPGs concerning the use of acupuncture for pain are inconsistent and often differ regarding the evidence-based science and accepted mechanisms by which acupuncture has persisting effects on chronic pain. As with all medicine, a risk-benefit analysis, consideration of clinical indications, and patient acceptance need to be considered.

“Massage and manipulative therapies, including osteopathic and chiropractic treatments, are commonly used for pain management. Such interventions may be clinically effective for short-term relief and is best accomplished in conjunction with consultation with the primary care and pain management team. Studies on massage have considered various types, including Swedish, Thai, and myofascial release. These studies do not provide adequate details of the type of massage provided. Systematic reviews note that the few studies looking at the effect of massage on pain use rigorous methods and large sample sizes. Other reviews recognize positive clinical effects on various pain conditions, including postoperative pain; headaches; and neck, back, and joint pain.

“MBSR, also discussed above in the Behavioral Health Approaches section, is a program that incorporates mindfulness skills training to enhance one’s ability to manage and reduce pain. Mindfulness enables an attentional stance of removed observation and is characterized by concentrating on the present moment with openness, curiosity, and acceptance. This approach allows for a change in one’s point of view on the pain experience. Studies support statistically significant beneficial effects for low-back pain. A meta-analysis demonstrated that mindfulness meditation significantly reduces the intensity and frequency of primary headache pain.

“Yoga, a practice rooted in ancient Hindu practice and a way of life that incorporates mind, body, and a spiritual approach, has shown improved outcomes for a variety of medical and nonmedical conditions. Yoga has become popular in Western cultures as a form of mind and body exercise that incorporates meditation and chants. Yoga’s use of stretching, breathing, and meditation has also been therapeutic in the treatment of various chronic pain conditions, especially low-back pain. Although there have been limited reports of pain symptoms becoming more severe with yoga, overall, the risk-benefit analysis suggests that yoga is generally safe, beneficial, and cost-effective, especially when administered in the group setting.

“Tai chi originated as an ancient Chinese martial art used to balance the forces of yin and yang. Modern tai chi has become popular for core physical strengthening through its use of slow movements and meditation. It has demonstrated long-term benefit in patients with chronic pain caused by osteoarthritis and other musculoskeletal pain conditions. Like yoga, tai chi appears to be safe; demonstrates positive results, especially over the long term; and can also be cost-effective in the group setting. Both yoga and tai chi can be delivered remotely via telemedicine/telehealth.

“Gaps and Recommendations

“Gap 1: There is a large variety of complementary and integrative health approaches that remain unknown to the broader medical community and that are often overlooked in the management of pain.

  • Recommendation 1a: Consider complementary and integrative health approaches, including 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 CPGs for the application of complementary and integrative health approaches for specific indications.

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

  • Recommendation 2a: Conduct further research on complementary and integrative health approaches 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 complementary and integrative health approaches 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.”

Notes: The recommendations do not adequately capture the depth or breadth of the gaps in education and in access and coverage. A strong recommendation on education of conventional practitioners to all of the complementary, integrative practices and practitioners needs to be the foundation for any of the others (such as 2b for instance) to gain much traction. Perhaps more importantly the critical challenges of how to include these still “outsiders” into payment and delivery are not faced head on. The recommendations need to specifically promote the development and examination of models for inclusion. Realistically, given the fact that most pain-related services from these practitioners remains in community settings, the recommendations should include specifically developing and examining models for integrative and team models in which all practitioners do not need to be practicing out of the same location. The language around “economic contribution” misses the need to simply expand coverage strategies so that all parties can consider inclusion without the barrier of coverage. Funds should be made available to support the examination of the multiple state pilots in places like Vermont and Oregon. In general, piloting new kinds of teams and coverage strategies should be promoted. The accent should specifically be on implementation research; less so on mechanism. The key challenges are how to integrate these humans – especially those placed off-site – into a what is drug-dominated culture.

“2.7.2 Older Adults Recommendation 1b: Use a multidisciplinary approach with a nonpharmacologic emphasis given the increased risk of medication side effects in this population.” (35)

“2.7.4 Pregnancy. Further complicating pain management in the peripartum period is the lack of CPGs for non-pharmacologic treatments that can decrease the potential adverse newborn outcomes associated with opioid therapy in pregnancy, such as neonatal abstinence syndrome (NAS). (36)

Note: The issues both here and in 2.7.2 are noted, but there are no related recommendations. Notably, in 2.7.3 ‘Unique Issues in Pain Management in Women” there are no specific notes regarding value of non-pharmacologic, integrative or complementary treatment, perhaps due to the lack of focused research. Given the high use of integrative among women, there would appear to be a gap.

“2.7.6 Sickle Cell Recommendation 1b: Conduct research targeted at nonopioid pharmacologic therapies and nonpharmacologic approaches for SCD pain management.” (38)

Note: The segments on special populations also include sections related to disparities (2.7.7) and another on military and veterans (2.7.8). Neither mentions anything integrative, which is particularly surprising with the latter. The former might be a place for exploration of group integrative services. The gap for veterans who receive care outside of veterans facilities is a place where coverage of integrative options as provided by licensed community-based practitioners is a barrier to optimal care.

3.2 “Cross Cutting” issues takes up the topic of education, both of the public and providers.

Note: These sections lack any mention of the importance of educating the public and providers about the value of integrative and non-pharmacologic options – a huge gap preventing optimal treatment. The recommendations focuses on “the biopsychosocial education model for physicians and other health care providers at all levels of training.” But it is not clear that this model encompasses the non-conventional non-pharma options. One effort might be to consider this a “gap” in the definition of “biopsychosocial.”

3.3 focuses on “Access” and includes segments on Insurance Coverage of Complex Management Conditions (3.3.2)

“Patients with complex and persistent pain often experience barriers to care related to nonexistent or insufficient insurance coverage and reimbursement for evidence-based medical, behavioral, and complementary pain management services. Although the HHS National Pain Strategy calls for greater access and coverage for pain management services, there is a lack of uniformity in insurance coverage and lack of coverage alignment with current practice guidelines for pain management. This is particularly true for the coverage of nonpharmacologic and behavioral health interventions.

“3.3.2 Recommendation 1b: CMS and private payors should investigate and implement innovative payment models that recognize and reimburse holistic, integrated, multimodal pain management, including complementary and integrative health approaches.” (49)

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

Notes: This is where the rubber meets the road. While the goal of fully, co-housed, integrative pain treatment may be aspirational, it doesn’t reflect the way many piece still piece together their teams from diverse community providers. Thus the gap of limited or no coverage of integrative health services and licensed complementary practitioners is not appropriately recognized. The “innovative payment models” may simply be to err on the side of coverage rather than denial of coverage for services that lead people away from opioids.  

Section 3.33 on the “Workforce” includes “Recommendation 1c: Expand the availability of non-physician specialists, including physical therapists, psychologists, and behavioral health specialists.”

Notes: The segment either does not acknowledge that acupuncturists, massage therapists and chiropractors are part of the workforce, or assumes that there are already sufficient numbers. If the latter, the unrecognized “gap” here is related to education – training programs that will best equip these practitioners to work well in coordinated teams – whether onsite or via linked community practices.

4.0 Research includes “Gap 4: There is a lack of research on and funding of potentially innovative modes of delivery and treatment.

  • Recommendation 4a: Increase the levels of research into novel strategies that target the underlying mechanisms of chronic pain, including pharmacologic and biologic research and development, medical devices, new and innovative technological advancements, medication delivery systems, neuromodulation, regenerative medicine, and complementary and integrative health approaches, as well as movement-based modalities.” (51)