April 13, 2020

The Debilitating Disease of Chronic Pain and the Case for Mandated Integration of Evidence-Based Alternatives into Individualized Treatment Plans

By Stephanie L. Flackman, J.D. Candidate 2020, Seton Hall University School of Law, Newark, NJ

We think of pain as a symptom. But in . . . patients [with chronic pain], the pain is the disease.

—Clifford J. Woolf, director of the F.M. Kirby Neurobiology Center at Boston Children’s Hospital and neurology professor at Harvard Medical School1  

Introduction

Shortly before receiving yet another lidocaine needle in the back of his neck, Staff Sergeant Josh Kisner, an Army veteran who suffers from severe headaches and chronic neck pain, confessed:

I don’t know why it is starting up again.  It had calmed down to a tolerable level.  It’s the stupidest things like reaching into the closet to grab a shirt.  For a while, I just lived on Percocets. It was the only way to do it.  That’s why I hate that drug and if they give it to me after surgery, I am going to beg for something else.2  

This was just another day “along recovery” for Kisner.  While deployed in Baqubah, Iraq in 2007, he avoided medical evacuation despite experiencing symptoms of traumatic brain injury (TBI).3  Fellow Army veteran Justin Springer made Kisner’s story accessible to the public through his documentary, Along Recovery, which bravely and respectfully follows four wounded soldiers whose lives changed dramatically after returning from Iraq and Afghanistan and captures their treatment experiences at Brooke Army Medical Center in San Antonio, Texas.4  Springer describes the health conditions faced by soldiers returning from overseas combat deployments, including severe headaches, chronic pain, sleeplessness, depression, and memory and concentration issues.5  “What is . . . frustrating is . . . you can have all these problems but there’s no real way to pinpoint why you are having them, so doctors will give you an MRI looking for damage but it almost always comes back negative and they can’t really see why you are having any problems.”6 

As Sean Hollins, a soldier suffering from a TBI explained, he would contemplate withholding how he felt from the hospital because “they say[,] hey[,] let’s give you some more medication,”7 and “I’m not a big fan of medications.”8  The initial instinct of doctors to prescribe to soldiers opioids as part of their treatment plan, without more, leads to opioid misuse and addiction.9

This sad reality highlights how the treatment process affects people suffering from chronic pain and comorbid conditions.10  Witnessing how these soldiers struggled through Springer’s eye-opening documentary footage frames the need to re-assess the current treatment protocols for the disease of chronic pain.

This article argues that there is a disconnect between the healthcare system’s understanding of chronic pain and the legal infrastructure surrounding the treatment of the disease. The healthcare delivery system currently limits or denies patients access to evidence-based alternatives that demonstrably alleviate chronic pain.

Part I provides a brief overview of the addicted brain and the opioid crisis and explains how these topics interrelate with chronic pain. It goes on to describe the disconnect between the healthcare system’s understanding of chronic pain and the legal infrastructure surrounding treatment of chronic pain.  Part II examines the efficacy of evidence-based treatment methods, existing guidelines on chronic pain treatment, the importance of integrating alternative treatment methods into a pain patient’s multidisciplinary treatment plan, and findings from brain imaging in patients with chronic pain.  It then discusses problems under current law, including the lack of insurance coverage for evidence-based alternative pain treatments and gaps due to disparities resulting from failure to implement a national framework. Part III proposes legal reforms to bridge these gaps. Specifically, it recommends that the Department of Health and Human Services (HHS) condition supplemental opioid-related state funding for patients with chronic pain on states implementing a mandated 15-week evidence-based alternative treatment plan in place of opioid therapy or, where medically necessary, in conjunction with prescription opioids.11 This funding should arise from a grant program similar to the opioid misuse treatment funding that the Substance Abuse and Mental Health Services Administration (SAMHSA) implemented through its State Targeted Response (STR) and State Opioid Response (SOR) grant funding programs, but this initiative should specifically be designated for chronic pain and seek to close the gap in treatment for chronic pain patients who need access to evidence-based alternatives. It further contends that Medicare should mirror the 15-week mandated program. A contingent funding program for additional reimbursement over current levels should also be enacted for state-based Medicaid to implement evidence-based alternatives as well.  In addition, a federal law must be enacted to require private insurance companies to cover these evidence-based alternatives.

Part IV examines some potential problems that could result from the solutions proposed in Part III. Those include the additional time and resource demands that would be required of doctors and other practitioners treating patients for chronic pain as well as insurance companies that have thus far failed to provide payment for alternative treatments. Part IV responds to these concerns  in several ways. It argues that: (1) chronic pain drains available funds in the United States because people are suffering and dying from the misuse of opioids; (2) billions of dollars have already been devoted to the opioid crisis with relatively little progress; (3) the cost of alternative treatments cannot truly be assessed without attempting to effectively implement a program to fill the known gaps in chronic pain treatment; and (4) certain of these recommended therapies are relatively cost- and resource-effective. This article concludes by reiterating the need for the implementation of mandatory, individualized evidence-based alternative treatment plans for chronic pain patients.

I.  Background

A.  The U.S. Opioid Misuse and Overdose Public Health Crisis: Brain Effects and Relevant Statistics

The country is facing a substance use disorder and drug overdose public health crisis.12  In the United States, over 130 people die each day after overdosing on opioids.13 In 2017, opioid use disorder resulted in 47,600 drug-overdose deaths.14 Although the mortality rate from opioid-related overdoses slightly declined in 201815 and stabilized in 2019 based on preliminary data, this statistic remains enormously high.16 Advances in neuroscience have shown the effects of drugs on neural pathways and differences in brain-wiring between people who suffer from opioid use disorder and those that do not.17 The Centers for Disease Control and Prevention (CDC) published opioid prescribing guidelines in 2016 which recommend dosage limitations and the satisfaction of certain threshold requirements prior to prescription renewal.18 While the guidelines are useful, there has been controversy surrounding their implementation.19 The guidelines are also insufficient standing alone because neuroscience research demands a change in the healthcare system’s approach to treating the underlying disease of pain due to its effects on brain circuitry and quality of life. To succeed against the opioid crisis, it is critical to reassess our view of the addicted brain, especially in the context of chronic pain.

B.  The Connection between Chronic Pain20 and Opioid Use Disorder

Chronic pain and opioid use disorder are interrelated.  The Institute of Medicine Report on Pain (IOM Report) suggests that 100 million Americans suffer from pain.21 Between the pharmaceutical industry targeting physicians with their marketing tactics to convince them to prescribe opioids for chronic pain22 and those doctors ultimately prescribing opioids for acute and chronic pain, societal circumstances exacerbated “the addiction crisis that has taken more than 400,000 lives over the past 20 years.”23  Many who suffer from chronic pain are either not receiving adequate treatment or relying on opioids.24  Critically, the relief from opioids is temporary, so opioids are not effective at managing patients’ pain.25  When the opioids wear off, the pain becomes prevalent.26  This, in turn, causes pain to affect patients like a debilitating disease, resulting in the patient’s need for more opioids and ongoing dependency, with limited relief from this disease.27

C.  The Health Care System’s Understanding of Chronic Pain and the Disconnect Reflected by the Legal Framework

Chronic pain is pain that persists past the end of the injury-related healing process, which differentiates chronic pain from acute pain.28 Chronic pain generally is pain that lasts more than three months.29 Pain, in general terms, results from neurological changes, affecting the central nervous system and peripheral nerves; it does not have to be the product of something else.30  In other words, “you can have an injury that heals and still have pain [or] you can have no specific injury and have pain . . . .[The pain] is in the brain.” 31  Chronic pain, as experienced by an individual, results from a combination of physical, psychological, and environmental factors, and thus is subjective and difficult to quantify objectively.32

The law relies on an outdated conceptualization of pain, which affects the evaluation of pain and legal compensation for it. Carradine v. Barnhart illustrates  how courts historically have approached chronic pain.33  Here, the plaintiff slipped and fell and her pain endured.34 The court denied her request for disability benefits, finding a lack of “objective evidence” to support her alleged pain.35  The appellate court reversed, reasoning that the plaintiff’s back surgery and use of painkillers were objective measures she took to lessen her pain. However, the court went on to point to the psychosomatic aspect of her pain by proclaiming that her back was fine, and the pain is all “in her head.”36  Such reasoning demonstrates the law’s lack of understanding of pain and its effect on the framework for providing relief for pain patients.37  At least one professor has pointed out the holes in the legal analysis in Carradine,38 noting that “the Social Security Administration said in 1984 that they wanted to reconsider their pain reg[ulations], and we are still in the same place.  It might be easier to reach judges and change the law interstitially through interpretation.”39

A more recent case indicates that courts may be beginning to recognize that chronic pain is a disease in and of itself and that change may be on the horizon. In Saunders v. Wilkie  a military veteran had been denied disability benefits.40 The Veterans Administration (VA) awards compensation benefits “for disability resulting from personal injury suffered . . . in line of duty,” but deemed this veteran ineligible for benefits because her patellofemoral pain syndrome did not result from an impairment; thus, despite being painful, it was not considered a disability.41 The court, upon review, reasoned that “pain is a form of functional impairment,” and thus can be a disability by itself, without the presence of a diagnosed injury.42

The current legal framework for addressing opioid addiction has taken necessary steps to address inaccessibility to opioid treatment and legislative action against illicit drugs. In 2018, Congress enacted the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the SUPPORT Act), which reaches the full spectrum of the healthcare industry, from patients themselves to medical practices and health insurance companies.43 The Centers for Medicare & Medicaid Services (CMS) has developed an action plan regarding changes to Medicare and Medicaid programs to address accessibility of treatment, as well as insurance coverage for medication-assisted treatment.44  SAMHSA developed two funding programs that sought to close the treatment gap between those in need of treatment for opioid misuse and those receiving treatment, the STR and SOR grants.45 In addition to federal action, states implemented laws addressing the opioid crisis. For example, Iowa mandates that physicians follow the CDC guidelines for chronic pain,46 whereas New York has strict limits on prescribing opioids for chronic pain, with exceptions for circumstances such as end-of-life treatment.47

These initiatives are intended to address the opioid crisis, but they have not gone far enough in mitigating the underlying issue that people need access to alternatives for relief from pain.  Moreover, legal restrictions on opioids support this article’s argument that access to evidence-based alternatives is more important now than ever, since there are more hurdles for patients who use opioids for chronic pain.

II.  The Evidence-Based Alternatives and Multidisciplinary Treatment Plans Chronic Pain Patients Deserve for Treating Their Disease

A.  Studies on the Efficacy of Evidence-Based Alternatives

Studies on non-pharmacological alternatives for treatment of chronic pain repeatedly deem such treatment methods effective.48 These alternatives have demonstrated effectiveness in improving patient outcomes, with an important caveat — that certain non-pharmacological evidence-based alternatives work better than others for specific chronic pain conditions.49 One 2018 review looked at the studies on the effectiveness of treatments such as exercise (including physical therapy), mind-body approaches (like cognitive behavioral therapy (CBT), biofeedback, meditation, and yoga), chiropractic care, and acupuncture for chronic pain.50 It suggests that these alternative treatment modalities create “slight to moderate” improvements in function and pain for specific chronic pain conditions and support the use of certain non-pharmacological alternatives for specific chronic pain conditions.51

The effectiveness of alternative treatments has also been recognized to some extent by the military. Soldiers suffering from injuries in training or combat showed trends in experiencing tremendous pain that was compounded by post-traumatic stress disorder (PTSD) and TBI, and sadly, showed little response to the treatment methods implemented by healthcare practitioners.52  Due to a high rate of psychological illnesses, suicide, and drug and alcohol addiction, the Army Surgeon General in 2009 chartered a Pain Management Task Force (PMTF) to make recommendations for  a “comprehensive pain management strategy that was holistic, multi-disciplinary and multi-modal in its approach.”53  The PMTF published a formal report in 2010, which included over 100 recommendations for practice, education, research, and organizational changes at all levels.54 The PMTF report recommended and endorsed evidence-based alternatives for chronic pain patients and multidisciplinary medicine methodologies through a patient-centered treatment plan.55 A subsequent study found that military personnel commonly used guided image therapy, relaxation techniques, and massage therapy at “an estimated 2.5–7 times the rate of civilians,” even though these alternatives were uncompensated therapies. The study suggested that “[t]he use of alternative therapy… as opposed to costly and sometimes addictive drug therapies may have positive long-term consequences for the health ….”56

The next section examines the efficacy of three specific evidence-based alternatives to prescription opioids to treat pain: CBT, physical therapy, and acupuncture.

1.  Efficacy of CBT for Chronic Pain

CBT is a form of psychotherapy focused on present circumstances, emotions, and uprooting negativity.57  Successful CBT helps patients with chronic pain recognize the role that negative emotions and cognition play in influencing pain perception.58 CBT helps patients recategorize pain by viewing it as a brain state, whereby the patient sees herself or himself as a well person who has pain.59  Ultimately, CBT decreases the patient’s obsession with pain, reduces patients’ constant urge for medical help, and assists patients in managing their diseases.60

Studies show that CBT improves one’s handling of chronic pain, psychologically and physiologically.61  One study compared patients with chronic pain to a healthy control group.62  The results established that, “[a]fter 11 weeks of CBT, patients with chronic pain had gray-matter volumes in the bilateral dorsolateral prefrontal, posterior parietal, anterior cingulate, orbitofrontal and sensorimotor cortices similar to those found in a healthy control group.”63 This study  confirmed that CBT can modify neural pathways previously controlled by pain, which uncouple when pain begins to subside, thus causing patients to begin to conceptualize pain in a different manner.64

A 2012 Cochrane Database Systematic Review65 found that CBT had “small to moderate positive effects on pain, disability, and mood immediately after treatment compared with [opioid therapy].”66 A recent systematic review of CBT supported the finding that CBT treatment helps improve quality of life.67 A randomized clinical trial found that patients who participated in CBT or other mindfulness-based therapy had better outcomes after 26 weeks than those who did not receive these treatments.68  An additional study compared different chronic low back pain treatment methods (CBT and mindfulness-based stress reduction through meditation and yoga) versus “usual care” (including opioid therapy) and concluded that eight weeks of CBT can improve back pain over six months.69

2.  How Physical Therapy can Effectively Alleviate Chronic Pain

Physical therapy utilizes exercises and physical manipulation to preserve, restore, and improve range of motion and physical function after impairment caused by an injury, disease, or disability.70  Physical therapy has benefits for certain types of chronic pain patients, including some who take prescription opioids.71

Physical therapy is an integral component of chronic pain treatment; it helps improve physical functionality and quality of life by enhancing a patient’s ability to engage in various activities.72 A JAMA Network Open study observed patients experiencing musculoskeletal pain in four categories (back, knee, neck, or shoulder pain) who returned to the emergency room or outpatient facility at least a second time due to continuing pain.73  This study analyzed outcomes of 88,985 patients with private insurance who either received physical therapy within 90 days of their initial doctor visit or did not receive such treatment.74  The data, collected at 91 and 365 days, found that a visit to a physical therapist early on (i.e., within 90 days of onset of pain) can eliminate patients’ long-term need for opioids and reduce the number of pills for those who do need to take prescription opioids for all four conditions assessed.75

3.  Acupuncture as an Efficacious Treatment for Chronic Pain

Acupuncture helps chronic low back pain more than “usual care” treatment methods (meaning treatment in accordance with the patient’s general practitioner’s assessment of the patient’s need, which can consist of a variety of interventions including physiotherapy, manipulation, exercises, and medication).76 Acupuncture involves stimulating specific points on the body by techniques, including insertion of thin metal needles through the skin.77 Ten million acupuncture treatments are administered in the United States annually.78  Three million American adults receive acupuncture each year, and chronic pain is the leading reason for seeking treatment.79 Acupuncture’s analgesic effect can be almost immediate for pain patients, although the mechanism for how it works is unclear.80

A systematic review and meta-analysis of trials assessing disease-related pain, which was performed to evaluate the effect of acupuncture on pain relief, found that acupuncture was associated with greater, immediate relief of chronic pain compared to sham acupuncture or analgesic injection.81  In a meta-analysis of randomized trials encompassing approximately 18,000 patients with chronic pain whose individual data was collected from the Acupuncture Trialists’ Collaboration, 90 percent of acupuncture benefits persisted 12 months after the conclusion of the course of treatment.82 Another study found that acupuncture impacts particular neural structures; after the insertion of the needle which stimulates pain pathways by inducing an activation of pain-related areas in the brain, the analgesic effect called “de qi” follows when soreness and distension occur post-acupuncture manipulation.83

B.  How Efficacy of Evidence-Based Alternatives has Led to Changes in Guidelines and the Clinical Framework

1.  CDC Guidelines and their Recommendation of Non-Opioids to Treat Chronic Pain

The efficacy of non-pharmacological evidence-based alternatives in comparison with opioids has resulted in changes to guidelines for clinicians.84 The CDC’s 2016 guidelines recommend non-drug approaches as the preferred treatment methods for chronic pain, and where pharmacological methods are necessary, the guidelines recommend using non-opioids over opioids.85  According to the guidelines, opioids should only be used (1) in combination with non-pharmacological evidence-based alternatives, and (2) if the “expected benefits for both pain and function are anticipated to outweigh risks to the patient.”86 The CDC explicitly notes that different evidence-based alternative treatments improve functionality, and the benefits last from two weeks to six months.87

The CDC guidelines created controversy because some providers were misapplying them in ways  inconsistent with the CDC’s recommendations or beyond their scope. As a result,  the CDC in 2019 released commentary highlighting that the guidelines are not a one-size-fits-all approach and intended for primary care physicians treating patients with chronic paid and thus not appropriate for patients with conditions where opioids are medically necessary, such as active cancer, sickle cell disease, and post-surgical pain.88 The commentary also warned prescribers about the dangers of tapering patients off opioids too abruptly and improperly applying dosage guidelines.89 The guidelines recommend non-pharmacological evidence-based alternatives as part of the treatment plan,90 but do not require such treatment for any particular length of time.

2.  The Pain Management Best Practices Inter-Agency Task Force Report and its Findings on Gaps and Recommendations 

As a result of 2016 federal legislation enacted in response to the opioid crisis, representatives from HHS, the VA and the Department of Defense joined forces to create the Pain Management Best Practices Inter-Agency Task Force (Pain Management Task Force).91  The Pain Management Task Force released a report with recommendations and guidelines for the treatment of chronic pain on May 9, 2019.92  The report emphasized the critical role of alternative treatment methodologies for chronic pain and recommended, among other things, physical therapy and occupational therapy.93 The Pain Management Task Force also identified barriers to access to care, including a lack of understanding of these alternative therapies for pain by both patients and clinicians. To accommodate these shortfalls, the Pain Management Task Force recommended investments in research to help providers incorporate these therapies into multidisciplinary treatment plans.94 The report further focused on reimbursement, recommending that Medicare and Medicaid as well as private payors “develop appropriate reimbursement policies; . . . minimize insurance coverage delays for clinically appropriate care; restore reimbursement to nonhospital sites of service to improve access; and lower the cost of interventional procedures.”95

3.  National Institutes of Health Funding Initiatives as a Step Toward Change

As a result of the Pain Management Task Force’s report and recommendations, Congress and federal agencies, including the National Institutes of Health (NIH) and HHS, decided to take action to address the ideas contained therein.96 On September 26, 2019, NIH awarded $945 million in funding across 41 states to support efforts to treat chronic pain through non-addictive methods, prevent opioid misuse and overdose, and improve recovery from opioid addiction through the Helping to End Addiction Long-Term Initiative (NIH HEAL Initiative).97 As the HHS Secretary pointed out, “This historic investment by NIH was made possible by funding secured from Congress by President Trump and will support [the future ability to] ‘manage pain in an effective, personalized way.’”98  As part of the program, people suffering from chronic back pain participated in a study on the effects of acupuncture on chronic back pain, and Medicare covered the treatments for participants (the results of which and resultant changes in insurance coverage are discussed infra).99

Francis S. Collins, M.D., Ph.D.,  the director of NIH stated:

It’s clear that a multi-pronged scientific approach is needed . . . and [t]his unprecedented investment in the NIH HEAL Initiative demonstrates the commitment to [reduce the risks of opioids, accelerate development of effective non-opioid therapies for pain and provide more flexible and effective options for treating addiction to opioids,] reversing this devastating crisis. 100

The NIH HEAL Initiative’s research efforts have begun, reaching 400 investigators across 41 states already, and will award $500 million per year over five years. It includes a component to reduce opioid-related overdose deaths by 40 percent over three years by pairing research sites with 67 communities seriously impacted by the opioid crisis.101 While this is a significant improvement in funding for chronic pain,102 it does not cover or require comprehensive implementation of evidence-based alternatives as part of treatment.

C.  The Necessity of Individualized, Patient-Centered Multidisciplinary Treatment Plans

Evidence-based nonpharmacologic therapies work well alone or as part of a multimodal treatment plan for chronic pain.103 These non-opioid therapies include exercise (such as physical therapy), mindfulness practices (yoga and meditation) and psychological treatment (CBT),  which are safe and effective ways to reduce the need for opioids.104  Evidence-based alternatives do not result in drug dependency (which makes them lower risk than opioids), and some can be practiced by individuals on their own (like meditation and exercises), making those treatments low cost. These treatment methods are accepted by patients, as discussed below.105 Many alternative treatment methods have been used successfully for thousands of years.106 Importantly, one modality may work for one pain condition but not others.107

There is a plethora of support for the notion that evidence-based alternatives are lower risk than opioid therapies.108  Opioid treatment can result in potential drug dependency, whereas evidence-based alternatives have lasting effects on alleviation of pain that can eliminate the need for opioids or reduce the dosage prescribed.109 Lower opioid use decreases both pharmacological side effects, as well.110  For example, in 1998 NIH released the “NIH Consensus Statement on Acupuncture . . . [, which] found that ‘the incidence of adverse effects [from acupuncture] is substantially lower than that of many drugs or other accepted procedures for the same conditions.’”111

In terms of cost-effectiveness, several economic analyses compared the costs and health effects of two or more evidence-based alternative therapies versus opioid therapy and showed more benefit for the economic investment in non-pharmacological evidence-based alternatives than opioids.112  For example, a review of cost-effectiveness of non-pharmacological alternatives for treating low back pain conducted by the Health Unit at the University of Birmingham demonstrated that acupuncture was a cost-effective option.113 Although individual acupuncture sessions cost more money per session, the pain management benefits lasted for a longer duration than the three-month study, which showed a longer time lapse between treatments, thus indicating an overall decrease in spending on treatment.114

A study conducted by an internist and professor at Yale Medical School who focuses his research on chronic pain looked at the barriers to increased use of non-pharmacological treatment modalities and pointed out that many patients believe that nonpharmacologic therapies are an additional expense.115 An analysis of the scope of economic benefits outlined in the Global Advances in Health and Medicine Journal116 challenges this perception.117 Costs savings from the use of evidence-based alternatives include less ongoing need for perpetual high tech standard care, fewer future visits to doctors, and less time out of the workplace.118 A study headed by a doctor affiliated with the Department of Health Services of the School of Public Health and Community Medicine at the University of Washington assessed the economic impact of insurance coverage for licensed complementary and alternative medical  (CAM) providers119 and reported a modest increase in insurance expenditures even when a significant number of insureds received non-pharmacological therapies.120  This finding led to a follow-up study of state-insured patients with back pain, fibromyalgia and menopause symptoms, which showed lower overall insurance costs for persons using evidence-based alternatives versus traditional treatment modalities, including opioids.121

A different study that looked at costs of an interdisciplinary pediatric pain clinic using acupuncture, biofeedback, psychotherapy and massage with medication found an overall decrease in inpatient and emergency department visits.122 The decrease in inpatient and emergency department visits resulted in cost savings of $36,228 per patient per year in hospital costs and $11,482 per patient per year in insurance costs (which equates to a reduction in economic cost by more than the monetary value of a future hospital visit).123 The cost savings realized from using evidence-based alternatives support the integration of these therapies in individualized interdisciplinary chronic pain treatment plans.124

Patients with the educational tools to understand the benefits of non-pharmacological alternatives accept these alternative treatment methods.125  A review that looked at education about and accessibility to non-pharmacological alternatives showed that 75 percent of patients who previously did not use evidence-based alternatives would utilize these treatments after gaining awareness of and accessibility to such therapies.126  This statistic is based on a study of 103 veterans in a Midwestern VA Medical Center that assessed whether veterans would report an increase in evidence-based alternative utilization after completing a formal pain education program.127  The educational course took place one day per week for 12 weeks and introduced veterans and their families to 23 different nonpharmacologic therapies for pain.128 The results demonstrated a significant increase in the overall utilization of evidence-based alternatives by veterans after completing the education program.129

In general, patients have better outcomes when they play an active role in healthcare.130  A survey of head nurses at hospitals that implemented integrative care programs found that “when patients are partners in their own care, they have better [health] outcomes and medication costs decrease.”131 When people utilize non-pharmacological alternatives, they feel better, and they actively choose to practice these alternative treatment methods on their own.132 As a result, patients experience pain relief benefits that lower utilization of opioid therapy.133 Importantly, and as suggested by the CDC’s 2016 prescribing guidelines commentary, clinicians need to weigh both the pros and cons of non-pharmacological alternatives based on the individual patient’s pain and develop a treatment plan that meets the patient’s goals.134

A study on the efficacy of a multidisciplinary approach for treating chronic pain assessed the effects of a 15-week multidisciplinary treatment program for pain rehabilitation, specifically focusing on pain and the ability to function and perform activities.135  The program consisted of CBT and exercise, along with individual and group sessions that incorporated other treatment modalities.136  The program rated participants’ pain and assessed the patients’ pain over time.137  The 165-patient study showed statistically significant improvements in pain, activities, and participation in the program over time (specifically by assessing participants’ occupational performance improvement in self‐care, productivity and leisure) between admission and discharge.138 The study reinforces the theory that non-pharmacological alternatives successfully treat chronic pain utilizing a multimodal approach.139

D.  Findings from Brain Imaging Related to Chronic Pain and Healing

Brain imaging demonstrates that pain causes neural pathways to rewire in the brain and, as patients recover from pain, these pathway changes uncouple.140 A study on brain activity in chronic pain patient groups (chronic back pain, osteoarthritis, chronic pelvic pain, chronic post-herpetic neuralgia, and chronic complex regional pain syndrome) — with either (1) spontaneous pain, (2) pain due to a stimulus that does not normally provoke pain, or (3) acute thermal mechanical stimuli — found that each chronic pain condition evoked a brain activity pattern unique to the condition.141  The study showed the presence of ongoing pain in different brain regions than acute pain, specifically regions more related to emotions and self-evaluation.142 

Tools to show objective physical properties of pain include EEG, MRI, and X-ray.143 As for pain diagnosis, there is no objective method to map a specific quantity of pain a person is experiencing. In addition, no test exists to measure pain intensity, and no instrument can locate pain precisely.144 Chronic pain can cause a reduction in the brain’s gray-matter volume, presumably due to the effects of chronic stress.145 Neuroimaging studies have demonstrated the reversal of such anatomical changes in the brain when effective CBT was part of the treatment regimen for chronic pain.146

There may be at least some growing recognition that a few forms of chronic pain are not caused by physical problems in the body, but rather through modified neural pathways in the brain.147 At least one study is analyzing the effects of different chronic pain alternative treatments and assessing their efficacy with fMRI brain scans.148 This study shows that just as the body learns pain forming new synaptic profiles in the brain, pain relief and renormalization of cognitive abilities spurs gray matter growth, which can reverse the disease process.149

E.  Disparities Due to Non-Existent Overarching Pain Management Framework and Lack of Insurance Coverage

1.  Problems with a Non-Universal Framework and Gaps in Coverage

Current federal and state law lacks an overarching framework that requires insurance coverage for pain management techniques. Although a handful of states have either enacted regulations or have pending legislation requiring insurance companies to provide coverage for specific evidence-based alternatives for pain management,150 states do not provide comprehensive coverage.151 In addition, no federal law serves this purpose and a national framework is essential.152  Without a national framework, unintended disparities in access to evidence-based alternatives will inherently exist and persist.

This article sees a need for an infrastructure similar to that which was put in place through the SUPPORT Act for opioid treatment. Without a system to improve access to alternatives, the less affluent and underinsured will continue to lack access to the evidence-based alternatives they need but cannot afford if not covered. Additionally, individuals in geographic regions (either with limited access to care providers or heavily populated with individuals suffering from chronic pain)  will continue to lack access to the evidence-based alternatives they need if, for example, they are unable to physically get to a care provider.  The variations in state laws and in private group and individual health plans as well as and the  lack of coverage under Medicare and Medicaid for most alternatives exacerbate the problem. 

2.  The Status of Insurance Coverage: Failure to Cover and Restrictions Limiting Accessibility

In 2017 the American College of Physicians (ACP) issued guidelines recommending non-pharmacological alternatives for chronic low back pain.153 Researchers then assessed the state of insurance coverage for non-pharmacological evidence-based alternatives to treat such pain.154  The study looked at minimum required coverage as well as limitations and exclusions according to states’ Essential Health Benefits (EHB) plans155 and found that healthcare practitioners and facilities did not optimize the coordination of non-pharmacological care across disciplines, despite the ACP’s recommendations suggesting incorporation of non-pharmacologic alternatives.156 In nearly all state-based individual and small group insurance policies, nowhere was chronic pain management and multidisciplinary rehabilitation addressed.157  Chiropractic care was the highest modality covered, in 46 states.158 However, acupuncture, massage therapy and biofeedback were  only covered by 10 states.159 Insurance did not cover tai chi or yoga in any  state.160

In many cases, private insurers cover CBT, but  solely for mental health conditions,161 not for chronic pain.162 However, CMS covers behavioral health integration services, including behavioral activation, which is considered the most important component of CBT.163  Insurance companies often provide coverage for physical therapy, but they routinely place limitations on the number of visits and reimbursement, which interferes with treatment efficacy.164 Medicare Part B only covers medically necessary outpatient physical therapy ordered by a doctor.165 Private payors are increasingly covering acupuncture for chronic pain, but not all health plans do so, and those that do vary on how and when they cover it.166 CMS, through its research partnership with NIH, assessed the benefits of acupuncture for chronic low back pain through the aforementioned study.167 Effective in January 2020, CMS now covers up to 12 sessions of acupuncture over 90 days for Medicare participants with chronic low back pain, with the number of sessions to be extended if the patient improves and cut off if the patient shows regression or no improvement.168 Thus, while insurance coverage for alternative treatments has increased to some extent, the many exclusions and restrictions impede patients’ access to them.169

III.  Solution—Legal Reform: Bridging the Gap Through a Mandatory Evidence-Based Treatment Plan in Place of Opioids (or in Conduction with Opioids Where Medically Necessary)

A.  Provision of HHS Funding for Chronic Pain to States Contingent upon Implementation of Evidence-Based Alternative Treatment Plans

There are gaps in the protocol for treating chronic pain, and the law needs to prioritize access to alternatives. Since clinical guidelines recommend using evidence-based alternatives as the front-line approach to treating chronic pain, the proposed course of action is implementation of a mandatory evidence-based treatment plan in place of opioid therapy or, where medically necessary, in conjunction with prescription opioids in order to facilitate use of non-pharmacological alternatives. HHS should mandate any combination of evidence-based alternative treatments as a component of each patient’s chronic pain management plan, in the patient’s healthcare provider’s discretion.170 In order to avoid running afoul of the Constitutional delegation of the right to regulate the practice of medicine to the states, HHS should condition future chronic pain funding to the states on each state’s compliance with an mandatory evidence-based treatment plan program.171  This funding would serve as additional, supplemental funding for states that choose to participate in implementing a 15-week evidence-based alternatives program. It would not take away any of the funding states currently receive.  This program would not affect current coverage for opioid treatment for patients with cancer that is not in remission, or patients in hospice, under end-of-life or palliative care, or any other similar circumstances where opioid treatment is medically necessary or where no form of evidence-based alternative is deemed useful for the patient by the patient’s healthcare provider. States participating could sign attestations electing to opt into providing a mandated evidence-based alternatives program, and upon renewal of the funding in future years if the state is not compliant, the state will not receive the evidence-based alternative program funds. Hopefully once states have started participating, the health outcomes of patients at healthcare facilities of participating states and beneficial economic effects will become apparent, and the state will take measures to ensure compliance. This funding should come from new grants in connection with the initiative to stop the opioid crisis.172 Under the U.S. Constitution,

[A]lthough the states have ceded the power to regulate interstate commerce to the federal government, they retained, via their police powers, the right to regulate any activity that poses a threat to the public health or safety of their citizens. Thus, state laws that seek to ban the import of milk from outside the state to protect local dairies are an unconstitutional attempt to control trade. In contrast, state laws that focus on consumer protection, such as requiring the sanitary inspection of imported milk and banning the import of contaminated milk, are constitutional, provided they also apply to milk produced within the state. This distinction between laws affecting commerce and laws affecting health and safety is important to medical care practitioners because the regulation of the practice of medicine is considered a health and safety issue and thus reserved to the states as a police power.173

The participating states should mandate for these patients a 15-week treatment plan (with the reasoning for the 15-week timeframe discussed in Section D, infra) that integrates the appropriate combination of non-pharmacological, evidence-based treatment alternatives, such as CBT, acupuncture, or physical therapy to meet each patient’s needs, in conjunction with opioids where the healthcare practitioner deems such treatment medically necessary.  A patient’s plan could incorporate telehealth  (for example, home sessions of CBT using telehealth technology) if mobility is an impediment to attending such treatment sessions.  The patients who need opioids would still be required to visit their healthcare providers regularly, pursuant to the clinical guidelines and laws currently in place for opioid prescribing. Providers should evaluate the individual’s plan and make adjustments as necessary.  For example, if a patient misses his or her mandated evidence-based alternative treatment session, the will need to re-assess the individual patient’s plan at a follow-up appointment and determine whether the patient should reschedule that alternative therapy or switch to a different evidence-based alternative therapy. If the provider sees no improvement or regression of the patient’s condition, the evidence-based alternatives aspect of the patient’s treatment should be tailored (i.e., changing the frequency of treatment or type of treatment), or stopped completely at the doctor’s discretion.174

HHS should consider mirroring this mandated 15-week alternative plan in the Medicare program. HHS should also increase Medicaid reimbursement for alternative pain therapies. Applying  South Dakota v. Dole, it is up to the states to follow a protocol to be determined by HHS and implemented to make evidence-based alternatives accessible to Medicaid participants or risk the withholding of funding.175 If a state elects to participate in providing a 15-week program of mandated evidence-based alternatives to Medicaid participants with chronic pain, that state will receive enhanced reimbursement for providing those evidence-based alternatives, and as a condition of receiving the increased reimbursement funding, the state will need to comply with HHS’s rules for the program implementing evidence-based alternatives.176     

B.  Required Insurance Coverage

Additionally, federal law must require private insurers to cover these alternative therapies for chronic pain. There is precedent for such a law; other federal laws, such as the SUPPORT Act and the Women's Health and Cancer Rights Act (WHCRA)177 require health insurance coverage for specific medical conditions.

The Pain Management Task Force made some relevant recommendations in its report on pain management best practices.178 It recommended that CMS and private payors implement improved payment models that cover integrated, multidisciplinary pain management, including CBT.179  For instance, CMS and private payors should specifically provide reimbursement for pain management consistent with the time and resources dedicated to educating and evaluating the patient (including risk for misuse), re-evaluating the patient after initiating treatment, and integrating evidence-based non-pharmacological alternatives to opioid therapy.180 CMS and private payors should also align their reimbursement guidelines for chronic multidisciplinary pain management with current clinical practice guidelines.181 Additionally, payors need to provide reimbursement for non-opioid pharmacologic therapies that are more expensive than opioids, such as long-acting local anesthetic injections, infusions, and intravenous acetaminophen analgesia, because there are long-term economic benefits related to providing this coverage.182

C.  The Pain Management Team Model

A team approach is crucial to the success of this proposal.183 This is a best practice; however, the current reimbursement models are barriers to providing this type of treatment.184 Payors should follow a chronic disease management model for reimbursement and should include reimbursement for multidisciplinary pain care similar to that used for cardiac rehabilitation and diabetes programs.185 In addition, reimbursement should cover the time teams spend coordinating patient care.186  The Pain Management Task Force also recommended development of a CPT code for pain care coordination and conferences.187 In addition, there should be a telehealth option for reimbursing evidence-based alternatives for pain management to facilitate access in underserved locations.188  This team model should also include prescribed group therapy to support those with chronic pain.

D.  Reasoning for 15-Week Program Length

This article derived the calculation of a 15-week mandated program based on the results of the studies discussed herein. The 15-week multidisciplinary treatment plan that included CBT showed statistically significant changes in patient outcomes during that time period.189  Another study of CBT found that after 11 weeks of CBT, patients with chronic pain had healthier gray-matter volumes in their brains.190 The aforementioned physical therapy study showed improvements after five to eight sessions.191 The acupuncture study found changes in patients over 12 weeks.192  Fifteen weeks seems like a prudent determination of a meaningful duration to start to create improved health outcomes for patients with chronic pain, as it is slightly longer than the duration where patients noticeably saw improvements for certain evidence-based alternative therapies.  The flexibility of an individualized plan to allow for extension as needed allows for the plan work effectively.

This proposal, while unique insofar as it is mandatory, is not novel in its elements or approach.  On March 7, 2014, the American Academy of Pain Medicine (AAPM) issued a position statement which proposed a framework regarding insurance coverage for patients with chronic pain.193 AAPM focused on unremitting pain and pain that fails to respond to usual treatment methodologies.194 The coverage framework included (1) medical management; (2) evidence- or consensus-based interventional/procedural therapies; (3) ongoing behavioral/psychological/psychiatric therapies; (4) interdisciplinary care; and (5) evidence-based complementary and integrative medicine (e.g., yoga, massage therapy, acupuncture, manipulation).195 AAPM suggested comparable coverage to the level of treatment coverage for people with mental-health disorders, and argued that limited visits along with other restrictions, including limited reimbursement, are not appropriate for patients with chronic pain.196

IV.  Addressing the Resistance to the Use of Alternative Treatment 

There are potential problems that could result from the solution proposed herein. Doctors and patients have voiced concerns about the “cost” of chronic pain management. The arguments include: (1) alternative treatment sessions cost more, (2) doctors will inefficiently use valuable (already limited) time on alternatives, and (3) insurance companies will need to cover unprecedented treatment options.197 The media, some studies, and others have echoed these concerns.198

In a study that interviewed primary care providers regarding treating co-morbid chronic pain and opioid use disorder, doctors reported that barriers to implementing alternative treatments include lack of resources, staff, time, and access to alternative treatments.199 For example, the primary care providers explained that they do not have the time to spend working with patients on alternative treatment plans.200 A separate study on provider and patient perspectives regarding alternatives to opioids for managing chronic pain quotes a primary care provider, “We get our little ten-minute per patient, which is so grossly, woefully an inadequate amount of time to see a patient. Ten minutes, right, for all your problems. And so nobody wants to take the time to explore things other than drugs for people with chronic pain.”201  This lack of time is problematic and is an issue that HHS contingent funding can address, since it can compensate healthcare providers for the time spent implementing non-pharmacological alternatives and coordinating care.

The aforementioned study from 2007 flagged similar and additional  concerns, including: 

additional time and energy investments, the need for specially trained personnel to administer the modalities, known or potential side effects, safety in combining alternatives and other modalities, likely acceptance by clients and the public (and hence the issue of long-term adherence), and ease of incorporation into traditional pain management practices.202

Another argument against the implementation of the proposed multidisciplinary, individualized evidence-based alternative plan for chronic pain patients is the contention that insurance companies will need to expend (potentially substantial) money on alternative treatments that they have failed to previously cover.203

These critiques beg the question: How can one assess whether these concerns are legitimate if the healthcare system has never truly attempted to incorporate these alternatives? Quick fixes with opioids alone have failed to solve problems for people with chronic pain, and the need for integration of non-pharmacological evidence-based alternatives is critical to helping these patients. The cost of alternative treatments cannot truly be assessed without attempting to effectively implement a program to fill known gaps in chronic pain treatment.

The rising cost of the opioid crisis also calls for the need to implement evidence-based alternatives. The White House Council of Economic Advisers estimated the cost of the opioid epidemic at $696 billion in 2018 and more than $2.5 trillion from 2015 to 2018.204  This cost is higher than the nation’s annual expenditures for heart disease, cancer, and diabetes combined.205 The chronic pain burden escalated from a cost of $500 billion in 2015,206 and the cost has and will continue to rise, especially as chronic illnesses increase over time.

This article aims to increase awareness, access, and utilization of safe, effective nonpharmacologic treatments through education of practitioners and patients; to disseminate and reimburse evidence-based treatment options; and to promote ongoing research focused on the therapeutic and economic impact, in the short and long term, of comprehensive care practices.207  Importantly:

[t]here is an additional benefit to many nonpharmacological pain care strategies; unlike drugs and surgery, the [evidence-based alternatives] involve patient participation and a commitment to self-care. Increased self-efficacy in managing pain correlates with improved mood and predicts improved outcomes in many chronic conditions, including pain.  For example, the military has studied ‘active self-care therapies’ as a category of pain management that may be of value in an integrated, multimodal approach.208

Patients can perform many of these therapies on their own, reaping the ongoing benefits, cost free, as they apply the therapies and techniques in their everyday lives.209  For instance, an individual can practice the CBT coping skills and perform exercise on his/her own, causing accelerated healing rates because of the added benefits achieved between sessions.210

Medicine and policy decision-making professionals acknowledge the crisis in pain and pain care.211  “If we could find a way of intervening, . . . then the . . . need [for] opioids or heavy doses of analgesics will diminish.”212 Through an effective legislative and regulatory framework, a solution can be found.  As mentioned earlier and worth repeating, “[i]nstead of symptom management, we would be managing the disease.”213 

Conclusion

People suffering from the disease of chronic pain need a mandatory program that incorporates evidence-based alternatives as a starting point for their treatment, in place of, or in conjunction with, the prescribing of opioids. Since states are responsible for regulating the practice of medicine, HHS should condition state funding for chronic pain, provided through supplemental grants in connection with the funding for the opioid crisis, on the state’s implementation of a 15-week mandatory evidence-based alternative program, which Medicare should mirror with its own program.  HHS should also grant contingent funding to states to expand evidence-based alternatives for Medicaid participants.  Federal law should require insurance coverage for provision of these evidence-based alternatives by private payors and government-funded programs. This contingent funding will boost integration of effective pain management techniques, help mitigate the deadly and costly opioid epidemic, and create longer sustaining benefits for chronic pain management.

This article was originally written for the Neuroscience and the Law course at Seton Hall University School of Law taught by Professor Jennifer Oliva, Esq.  The author wishes to thank Professor Oliva for her energy and enthusiasm about the course’s subject matter and her guidance on this article.

  1. Bernstein, L., For some with chronic pain, the problem is not in their backs or knees but their brains, Wash. Post (Sept. 23, 2019), https://www.washingtonpost.com/national/health-science/for-some-with-chronic-pain-the-problem-is-not-in-their-backs-or-knees-but-their-brains/2019/09/23/80538660-5d5c-11e9-842d-7d3ed7eb3957_story.htmlSee also Jones, O.D., et al., Law and Neuroscience 344 (2014). 
  2. Along Recovery, (Gravitas Ventures May 20, 2012), https://www.amazon.com/Along-Recovery-Justin-Springer/dp/B00GDF77AM. 49:11-49:40. 
  3. Along Recovery, supra n. 2, at 17:10-17:16.
  4. Id. at 17:10-17:16.
  5. Id. at 20:28-20:56.
  6. Id. at 20:28-20:56.
  7. Id. at 28:00-28:32.
  8. Id. at 30:50-31:02.
  9. See Oliva, J.D., Son of Sam, Service-Connected Entitlements, and Disabled Veteran Prisoners, 25 Geo. Mason L. Rev. 302, 303 n.7 (2018) (citing sources that reference veterans facing addiction, including  Golub, A. & Bennett, A.S., Introduction to the Special Issue: Drugs, Wars, Military Personnel, and Veterans, 48 Substance Use & Misuse 795, 796 (2013)).
  10. Roe, J., One veteran tells the story of his struggles trying to manage chronic pain, ABC News Channel (Sept. 11, 2019), https://newschannel9.com/features/price-of-freedom/one-veteran-tells-the-story-of-his-struggles-trying-to-manage-chronic-pain (describing veteran Scott McConathy’s struggles because for 12 years doctors gave him 60 milligrams of Morphine three times per day, lowered to 40 milligrams of hydrocodone, then cut him off).
  11. In the alternative, state-level public health laws or regulations could effectively create the same outcome of improving access to evidence-based alternatives for chronic pain, perhaps incentivized by funding from the CDC, but is not addressed herein, except to note that authority for the CDC to fund such initiative would arise from the CDC’s National Center for Chronic Disease Prevention and Health Promotion’s mission to mitigate chronic diseases; the fact that patients with chronic conditions often have chronic pain and take opioid prescriptions; and the alarming statistic that from 2011 to 2015, more than 90% of the country’s opioid-related hospitalizations were among patients with multiple comorbid chronic diseases, and the trend is increasing.  See Rajbhandari-Thapa, J. et al., Opioid-Related Hospitalization and Its Association With Chronic Diseases: Findings From the National Inpatient Sample, 2011–2015, 16 Preventing Chronic Diseases (2019).
  12. Seth, P., et al., Overdose Deaths Involving Opioids, Cocaine, and Psychostimulants — United States, 2015–2016, 67 Morbidity & Mortality Wkly. Rep. 1, 1 (2018).
  13. National Institutes of Health, national Institute on Drug Abuse, Opioid Overdose Crisis, https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis (last accessed Nov. 21, 2019).
  14. See U.S. Dep’t of Health & Human Servs., Ctrs. for Disease Control & Prevention, Overview of the Drug Overdose Epidemic: Behind the Numbers, https://www.cdc.gov/drugoverdose/data/ (last accessed Nov. 12, 2019) (citing Scholl, L. et al., Drug and Opioid-Involved Overdose Deaths — United States, 2013–2017, 67 Morbidity & Mortality Wkly. Rep. 1419, 1419 (2019)).
  15. The CDC released statistics covering the one-year period ending in February 2019, which showed an estimated 2.9% decline in the total number of overdose deaths in the United States from the previous year, of which approximately 7 out of 10 deaths were due to opioids.  See Press Release, NCHS Releases New Monthly Provisional Estimates on Drug Overdose Deaths (Sep. 11, 2019), https://www.cdc.gov/nchs/pressroom/podcasts/20190911/20190911.htm (quoting U.S. Dep’t of Health & Human Servs., Ctrs. for Disease Control & Prevention, 12 Month-ending Provisional Number of Drug Overdose Deaths, https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm).
  16. Kravitz-Wirtz, N., et al., Association of Medicaid Expansion With Opioid Overdose Mortality in the United States, 3 The J. of the American Med. Ass’n Network Open 1, 2 (2020) (showing that expanding eligibility for Medicaid may assist with mitigating the opioid overdose epidemic because where Medicaid expanded, the total opioid overdose deaths declined, particularly deaths involving heroin and synthetic opioids, with the exception of methadone, which had increases in its related mortality); see also U.S. Dep’t of Health & Human Servs., Ctrs. for Disease Control & Prevention, 12 Month-ending Provisional Number of Drug Overdose Deaths, https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm (last accessed Feb. 26, 2020) (showing a 0.8% decline in the opioid-related morbidity rate).
  17. Leshner, A.I., Addiction is a Brain Disease, and It Matters, 278 Science 45, 45 (1997), in Jones, O.D., et al, Law and Neuroscience 592 (2014). 
  18. Dowell, D., et al., CDC Guideline for Prescribing Opioids for Chronic Pain, 65 Morbidity & Mortality Wkly. Rep. 1, 30 (2016), https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fmmwr%2Fvolumes%2F65%2Frr%2Frr6501e1er.htm.
  19. See infra notes 84-85 and accompanying text.
  20. This article focuses on chronic pain without delving into acute pain. The medical industry views and treats acute pain differently from chronic pain. Doctors prescribe opioids over shorter time periods for acute pain, and acute pain subsides more quickly than chronic pain, avoiding the need for ongoing opioid treatment. While addiction is still a concern, when acute pain subsides, patients do not need opioids any longer, so doctors can taper them off the medications. The problem of relief from pain is not an ongoing issue for patients with acute pain and the need for evidence-based alternatives is not as prevalent.  
  21. Position Statement, American Academy of Pain Medicine, Use of Opioids for the Treatment of Chronic Pain (Mar. 7, 2013), https://painmed.org/about/position-statements/use-of-opioids-for-the-treatment-of-chronic-pain (citing Institute of Medicine, Committee on Advancing Pain Research, Care and Education, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, Washington (DC): National Academies Press (US) (2011) [hereinafter IOM Report]).
  22. Horwitz, S., et al., The Opioid Files – Inside the opioid industry’s marketing machine, Wash. Post (Dec. 6, 2019), https://www.washingtonpost.com/graphics/2019/investigations/opioid-marketing/.
  23. See Bernstein, supra n. 1, at 1 (observing that casually prescribing opioids plays a role in opioid-related deaths).
  24. Seth et al., supra n. 12, at 1.
  25. Id. at 1.
  26. Id.
  27. Seidholz, M. & Young, A., Can Cognitive Behavioral Therapy Help Reduce Pain Better Than Opioids?, Everyday Health (Nov. 21, 2018), https://www.everydayhealth.com/opioids/can-cognitive-behavioral-therapy-help-reduce-pain-better-than-opioids/.
  28. Jones, O.D., et al, , Law and Neuroscience 344 (2014). 
  29. Murphy, J. L.,  et al., Cognitive behavioral therapy for chronic pain among veterans: Therapist manual 11, U.S. Department of Veterans Affairs, https://www.va.gov/PAINMANAGEMENT/docs/CBT-CP_Therapist_Manual.pdf (last accessed Nov. 21, 2019).
  30. Pustilnik, A. C., Address at the Mass General Hospital Center for Law, Brain & Behavior Public Symposium: The Pain Brain in Evidence and Policy—Visible Solutions: How Neuroimaging Helps Law Re-Envision Pain (June 30, 2015).
  31. Id. at 10:26-10:30 (emphasis added).
  32. Gabler, D. J., Conscious Pain and Suffering Is Not a Matter of Degree, 74 Marq. L. Rev. 289, 296 (1991).
  33. See Carradine v. Barnhart, 360 F.3d 751 (7th Cir. 2004). 
  34. Id. at 753.
  35. Id. at 751.
  36. Id. at 754.
  37. Pustilnik, supra n. 30, at 03:15-04:02.
  38. Id. at 05:05-08:28.
  39. Id. at 50:48-51:38.
  40. Saunders v. Wilkie, 886 F.3d 1356, 1358 (Fed. Cir. 2018).
  41. Id. at 1359; see also 38 U.S.C. § 1110 (2020).
  42. Id. at 1364.
  43. The Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, Pub. L. No. § 115-271, 132 Stat. 3894 (requiring: (1) Coverage of certified opioid treatment programs for Medicare patients and temporary coverage of medication-assisted treatment for patients with Medicaid; (2) An initial examination for Medicare enrollees that includes an opioid use disorder screening; (3) That providers check the prescription drug monitoring program (PDMP), provide educational materials on opioid use, pain management, and opioid alternatives before prescribing opioids, submit controlled substance orders through an electronic prescription program, and utilize a secure online portal for data sharing to prevent fraud and abuse of opioids; (4) Parity of children’s programs related to mental health and substance use disorder services with other medical services; (5) That the Substance Abuse and Mental Health Services Administration (SAMHSA) award grants to operate opioid recovery centers; (6) A loan repayment program; and (7) Telehealth changes (mentioned supra), all supported by $3 million of funding in trust until the funds are exhausted).
  44. Id. at 32. 
  45. SAMHSA, as one of the main federal agencies charged with providing funding to address the opioid epidemic, administered two main opioid grant programs: the State Targeted Response (STR) and the State Opioid Response (SOR) grants. STR, authorized by the 21st Century Cures Act, requires that no less than 80 percent of the grant must fund treatment services.  STR awarded the funds to states using a formula, with $500 million awarded to states in 2017 and $500 million in 2018. Three states received $1 million of supplemental funding in 2018 (the 10 states with the most overdose deaths were eligible to apply for this STR supplemental funding). As part of SOR, the second funding program, states received separate funding in 2018. The purpose of the SOR program is to expand and improve the STR program. Of the $1 billion pool of funds, the programs set 15 percent aside for states with the highest rate of drug overdose deaths. The specifications for applications for funding include the entire continuum of care, prevention, treatment, and recovery, and the requirement to make treatment medications — such as methadone, naltrexone, and buprenorphine — available. The STR and SOR programs combined made up 21 percent of total opioid-related appropriations in 2018. See Hoagland, G. W., et al., Bipartisan Policy Center, Tracking Federal Funding to Combat the Opioid Crisis, https://bipartisanpolicy.org/wp-content/uploads/2019/03/Tracking-Federal-Funding-to-Combat-the-Opioid-Crisis.pdf (last accessed Mar. 3, 2020).
  46. See Iowa Admin. Code § 653-13.2 (2016).
  47. New York (1) requires physicians to access the state’s PDMP before initiating a controlled substance treatment (N.Y. Pub. Health § 3334-a(2) (2013)) and (2) mandates that for chronic pain, opioids shall not be initiated or continued for pain lasting over three months or past the normal healing cycle without a written treatment plan, with an exception to this requirement for patients under treatment for cancer that is not in remission or patients in hospice, under end-of-life or palliative care (N.Y. Pub. Health § 3331(5) (2016)).
  48. See e.g., Majeed, M. H.,  et al., Psychotherapeutic interventions for chronic pain: Evidence, rationale, and advantages, 54 Int. J. of Psychiatry in Med. 140, 140 (2018) (emphasizing efficacy of psychotherapeutic interventions); Yin, C. S., et al., Acupuncture for chronic pain: an update and critical overview, 30 Current Opinion in Anesthesiology 583, 592 (2017) (reiterating acupuncture’s effectiveness for treating chronic pain).
  49. Skelly, A. C.  et al., Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review, 209 Agency for Healthcare Research and Quality  1, 12 (2018), https://www.ncbi.nlm.nih.gov/books/NBK519958/.
  50. Id. at 14.
  51. Id.
  52. Schoomaker, E. & Buckenmaier, C.,  Call to Action: ‘If Not Now, When? If Not You, Who?,’ 15 Pain Medicine S4, S5 (2014).
  53. Id. at S5.
  54. Id.
  55. Id.  Note that the IOM report made similar recommendations.
  56. Goertz, C., et al., Military Report More Complementary and Alternative Medicine Use than Civilians, 19 J. Alt. & Complementary Med. 509 (2013).
  57. Hanscom, D.A., et al., Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview, 5 Global Spine J. 496, 496 (2015).
  58. Id. at 497.
  59. Id.
  60. Murphy, supra n. 29, at 26.
  61. Id. at 10.
  62. Seminowicz, D.A., et al., Cognitive behavioral therapy increases prefrontal cortex gray matter in patients with chronic pain, 14 J. Pain 1, 5 (2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874446/pdf/nihms532417.pdf.
  63. Id. at 2.
  64. Id. at 6.
  65. A Cochrane Systematic Review is a systematic review in healthcare that seeks to identify and evaluate empirical evidence to answer a targeted research question, through an approach that aims to minimize bias and is updated to reflect new evidentiary findings over time. It is prepared and supervised by an editorial team and utilized by healthcare practitioners, patients, decision-makers, and researchers. Cochrane Library, Cochrane Database of Systematic Reviews, https://www.cochranelibrary.com/cdsr/about-cdsr (last accessed Feb. 26, 2020).
  66. Williams, A., et al., Psychological therapies for the management of chronic pain (excluding headache) in adults, 11 Cochrane Database Syst. Rev. 1, 2 (2012), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6483325/pdf/CD007407.pdf.
  67. Gilpin, H.R., et al., Predictors of treatment outcome in contextual cognitive and behavioral therapies for chronic pain: a systematic review, 18 J. Pain 1153, 1153 (2017).
  68. Cherkin, D. C., et al., Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: a randomized clinical trial, 315 JAMA 1, 8 (2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4914381/pdf/nihms781082.pdf.
  69. Wein, H., Meditation and cognitive-behavioral therapy ease low back pain, NIH Research Matters (Mar. 29, 2016), https://www.nih.gov/news-events/nih-research-matters/meditation-cognitive-behavioral-therapy-ease-low-back-pain (citing  Cherkin et al., supra n.68, at 8 (2016)).
  70. Physical Therapy Definition, Merriam-Webster Dictionary, available at https://www.merriam-webster.com/dictionary/physical%20therapy.
  71. These evidence-based alternatives are not appropriate as the front-line approach for conditions like oncology and terminal illnessesSee Press Release, Centers for Disease Control and Prevention, CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain (Apr. 24, 2019), https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html [hereinafter CDC Press Release].
  72. Sun, E., et al., Association of Early Physical Therapy With Long-term Opioid Use Among Opioid-Naive Patients With Musculoskeletal Pain, 1 The J. of the American Med. Ass’n Network Open 1, 7 (2018).
  73. Id. at 1.
  74. Id. at 3.
  75. Id. at 6.
  76. Trigkilidas, D., Acupuncture therapy for chronic lower back pain: a systematic review, 29 Annals of The Royal C. of Surgeons of England, 595, 596  (2010).
  77. Mayo Clinic, Acupuncture, https://www.mayoclinic.org/tests-procedures/acupuncture/about/pac-20392763. (last accessed Nov. 21, 2019).
  78. Hao, J. & Mittelman, M., Acupuncture: Past, Present, and Future, 3 Global Advances in Health and Med. 6, 6 (2014). 
  79. Vickers, A. J.,  et al., Acupuncture for chronic pain: individual patient data meta-analysis, 172 Archives of Internal Med. 1444, 1444 (2012).
  80. Kawakita K. & Okada, K., Acupuncture therapy: mechanism of action, efficacy, and safety: a potential intervention for psychogenic disorders?, 8 BioPsychoSocial Med. 1, 2 (2014).
  81. Sham acupuncture is a control mechanism used to assess the effects of acupuncture. Penetrating sham acupuncture uses blunted needles, and the needles are purposely inserted outside the pressure point area. Non-penetrating sham acupuncture uses a device, such as a telescope or other instrument that does not pierce the skin in place of needles; it is used to determine whether or not the treatment is distinguishable from acupuncture needles. See Xiang, A.,  et al., The Immediate Analgesic Effect of Acupuncture for Pain: A Systematic Review and Meta-Analysis, 2017 Evidence-Based Complementary & Alternative Med. 1, 4 (2017).
  82. MacPherson, H. & Vertosick, E. A., The persistence of the effects of acupuncture after a course of treatment: a meta-analysis of patients with chronic pain, 158 Pain 1, 11 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5393924/.
  83. Chae, Y., et al., How placebo needles differ from placebo pills? 9 Frontiers Psychiatry 1, 3 (2018).
  84. Dowell et al., supra n. 18, at 11.
  85. Centers for Disease Control and Prevention, Guidelines for Prescribing Opioids for Chronic Pain, https://www.cdc.gov/drugoverdose/pdf/guidelines_factsheet-providers-a.pdf. (last accessed Nov. 21, 2019).
  86. Id. at 1.
  87. Dowell et al., supra n. 18, at 7; see also Williams et al., supra n. 66 at 2 (noting effects of CBT immediately following treatments and again after six months);  Geneen, L. J., et al., Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews, 1 Cochrane Database Syst. Rev. 1, 2 (2017) (determining efficacy of physical therapy after three to six months of treatment).
  88. Id. at 29.
  89. Id. at 13.
  90. Id. at 11.
  91. Comprehensive Addiction and Recovery Act of 2016, Pub. L. No. §114-198, 130 Stat. 695.
  92. See generally Pain Management Best Practices Inter-Agency Task Force, U.S. Department of Health and Human Services, Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations (2019) [hereinafter Task Force Report].
  93. Id. at 21.
  94. Id. at 62.
  95. Id. at 37.
  96. For example, under Section 6032 of the SUPPORT Act, where CMS, as part of its efforts to implement Section 6032, sent the American Pharmacists Association (APhA) a request for information to help with the development of a CMS action plan. APhA, in its response and effort to improve accessibility to patient care and public health, suggested that it “welcome[s] the opportunity to work with HHS, CMS and Congress to develop alternative legislative solutions that utilize pharmacists to meet patients’ care needs, including those who need pain management and substance use disorder services.” (See Letter from Thomas E. Menighan, Executive Vice President and CEO of the American Pharmacists Association to the Centers for Medicare & Medicaid Services 1 (Oct.11, 2019) (on file with the author)).
  97. Press Release, NIH Office of the Director, NIH funds $945 million in research to tackle the national opioid crisis through NIH HEAL Initiative (Sept. 26, 2019), https://www.nih.gov/news-events/news-releases/nih-funds-945-million-research-tackle-national-opioid-crisis-through-nih-heal-initiative [hereinafter NIH HEAL Funding]; see also Kaiser Health Network, NIH Awards $945M For Research On Treating Chronic Pain, Opioid Addiction, Kaiser Health News (Sept. 27, 2019), https://khn.org/morning-breakout/nih-awards-945m-for-research-on-treating-chronic-pain-opioid-addiction/.
  98. Press Release, U.S. Department of Health & Human Services, Trump Administration Announces $1.8 Billion in Funding to States to Continue Combating Opioid Crisis (Sept. 4, 2019), https://www.hhs.gov/about/news/2019/09/04/trump-administration-announces-1-8-billion-funding-states-combating-opioid.html [hereinafter Funding to States].
  99. Id. at 1.
  100.   NIH HEAL Funding, supra n. 97, at 1. See also Acute to Chronic Pain Signatures Program, https://heal.nih.gov/research/clinical-research/pain-signatures (last accessed Nov. 21, 2019) (awarding $40 million previously to researchers to study 3,600 patients over two and a half years to find pain biomarkers and determine the biological, psychological and social factors that predict who is prone to developing chronic pain, with the goal of determining preventative treatment strategies).
  101. NIH HEAL Initiative, Healing Communities Study, https://heal.nih.gov/research/research-to-practice/healing-communities (last accessed Feb. 28, 2020).
  102.  For comparison, in 2014 NIH received $30 billion in taxpayer funds to improve health across the country and spent 95% less on chronic pain than it did on heart disease, cancer and diabetes. Chronic pain funding at that time totaled approximately $402 million dollars. See Chronic Pain Research Alliance Federal Investment in Pain Research, http://www.chronicpainresearch.org/Research. (last accessed Nov. 26, 2019).
  103.  Tick, H., et al., Evidence-Based Nonpharmacologic Strategies for Comprehensive Pain Care: The Consortium Pain Task Force White Paper, 14 Explore 177, 187 (2018).
  104.  Id. at 187.
  105.  Tabish, S. A., Complementary and Alternative Healthcare: Is it Evidence-based? 2 Int. J. Health Sci. 1, 1 (2008).
  106.  Id. at 1.
  107.  Task Force Report, supra n. 92, at 32.
  108.  See The Joint Commission Division of Healthcare Improvement, Non-pharmacologic and non-opioid solutions for pain management, 44 Quick Safety 1, 1 (2018), https://www.jointcommission.org/assets/1/23/QS_Nonopioid_pain_mgmt_8_15_18_FINAL.pdf.
  109.  Sun et al., supra n. 72, at 6.
  110. Id. at 1.
  111. Tick et al., supra n. 103, at 25 (citing NIH Consensus Conference, Acupuncture, 280 The Journal of the American Medical Association 1518 (1998)).
  112. Herman, P. M., Evaluating the economics of complementary and integrative medicine, 2 Global Advances in Health and Med. 56, 59 (2013) (citing Wonderling, D., et al., Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care, 328 BMJ 747 (2004); Hollinghurst, S., et al., Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation, 11 BMJ 337, 337 (2008)). 
  113. Andronis, L., et al., Cost-effectiveness of noninvasive and non-pharmacological interventions for low back pain: a systematic literature review, 15 Applied Health Econ. & Health Policy 173, 173 (2017).
  114. Id. at 173.
  115. Becker, W. C., et al., Barriers and facilitators to use of non-pharmacological treatments in chronic pain, 18 BMC Family Practice 41 (2017).
  116. See generally Herman, supra n. 112 at 56.
  117. Herman, supra n. 112, at 56.
  118. Id.
  119. Under Washington state law, private insurance companies are required to cover services of licensed CAM providers.  Wash. Admin. Code § 284-170-270 (Lexis Advance through the 20-01 Washington State Register (WSR), January 2, 2020).
  120.  Lafferty, W. E., et al., Insurance coverage and subsequent utilization of complementary and alternative medicine providers, 12 Am. J. of Managed Care 1,6 (2006).
  121. Lind, B. K., et al.,  Comparison of health care expenditures among insured users and nonusers of complementary and alternative medicine in Washington State: a cost minimization analysis, 16 J. Alt. & Complementary Med. 411, 414 (2010).
  122.  Mahrer, N. E., et al., A Cost-Analysis of an Interdisciplinary Pediatric Chronic Pain Clinic, 19 J. Pain 158, 163 (2018).
  123. Id. at 163.
  124. Id. at 164.
  125. Cosio, D. &  Lin, E., Effects of a Pain Education Program in Complementary & Alternative Medicine Treatment Utilization at a VA Medical Center, 23 Complementary Therapies in Medicine, 413, 414 (2015).
  126. Id. at 1.
  127. Id.
  128. Id.
  129. Id.
  130.  Thomas, M. A., Pain Management – The Challenge, 5 Pain Management 15, 19.
  131. Kaechele, C., Improving Patient Comfort with Nonpharmacologic Therapies, (Apr. 20, 2018) (unpublished thesis, East Carolina University) (on file with East Carolina ScholarShip Digital Archive),  http://thescholarship.ecu.edu/bitstream/handle/10342/6667/Kaechele_Final.docx?sequence=1&isAllowed=y (citing  Halm, M. & Katseres, J., Integrative Care -- The Evolving Landscape in American Hospitals, 115 Amer. J. of Nursing (2015)).
  132. Id. at 13.
  133. Id. at 47 (citing Jarrett A., et al., Nurses' knowledge and attitudes about pain in hospitalized patients, 27 Clinical Nurse Specialist, 81 (2017) and Montross-Thomas, L.P., et al., Hospitalized patients' preferences, beliefs, and stated willingness to pay for complementary and alternative medicine treatments, 23 J. Alt. & Complementary Med. 259 (2017).
  134. Mahrer, et al., A Cost-Analysis of an Interdisciplinary Pediatric Chronic Pain Clinic, 19 J. Pain, 158, 158 (2018).
  135. Koele, R. et al., Multidisciplinary rehabilitation for chronic widespread musculoskeletal pain: results from daily practice, 12 Musculoskeletal Care 210, 210 (2014).
  136. Id. at 210.
  137. Id.
  138. Id.
  139. Id.
  140.  Borsook, D., Address at the Mass General Hospital Center for Law, Brain & Behavior Public Symposium: The Pain Brain in Evidence and Policy — Visible Solutions: How Neuroimaging Helps Law Re-Envision Pain (June 30, 2015), 31:00-31:06.
  141. Baliki, M. N. &  Apkarian, A.V.,  Nociception, pain, negative moods and behavior selection, 87 Neuron 474, 485 (2015).
  142. Id. at 487.
  143. Morton, D. L.,  et al., Brain imaging of pain: state of the art, J. of Pain Research 613, 614 (2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019436/pdf/jpr-9-613.pdf.
  144. Jones, O. D., et al., Law and Neuroscience 591 (2014). 
  145. Majeed, M.H., & Sudak, D.M., Cognitive Behavioral Therapy for Chronic Pain-One Therapeutic Approach for the Opioid Epidemic, 23 J. Psychiatric Practice 409, 412 (2017).
  146. Id. at 412.
  147. Id. at 1.
  148. Schubiner, H., Breakthrough Study: Overcoming Chronic Pain, https://www.indiegogo.com/projects/breakthrough-study-overcoming-chronic-pain#/. (last accessed Nov. 24, 2019).
  149. Id. at 1.  See also  Apkarian, The Brain in Chronic Pain: Clinical Implications 1 Pain Management 577 (2011), in Jones et al., supra n. 1, at 348. 
  150. See e.g., W. Va. Code § 16-54-8 (2018) (showing a state bill that passed and includes coverage for chiropractic care as treatment for pain). 
  151. Under Washington state law, private insurance payors are required to cover licensed CAM providers’ services. Wash. Admin. Code § 284-170-270 (Lexis Advance through the 20-01 Washington State Register (WSR), January 2, 2020).
  152. Carlson, D. & Thompson, J. M., The Role of State Medical Boards, AMA J. of Ethics, https://journalofethics.ama-assn.org/article/role-state-medical-boards/2005-04. (last accessed Nov. 29, 2019).
  153. Id. at 2.
  154. Bonakdar, R., et al., Analysis of State Insurance Coverage for Nonpharmacologic Treatment of Low Back Pain as Recommended by the American College of Physicians Guidelines, 8 Global Advances in Health & Med. 1, 2 (2019).
  155. Id. at 8.
  156. Id. at 2.
  157. Id. at 5.
  158. Id. at 3.
  159. Id. at 5.
  160.  Id.
  161. This coverage for CBT for mental health conditions is likely due to the Mental Health Parity Act, which  mandates that requirements for offered mental health benefits cannot be more restrictive than those for physical health benefits. Mental Health Parity Act, Pub. L. No. §104-204, 110 STAT. 2874.
  162. Bonakdar et al., supra n. 154, at 5 (noting that only two states’ EHB coverage explicitly included CBT but whether it encompassed CBT for pain was unclear; and although CBT may be covered under behavioral services when not specifically noted, 39 other state EHB plans required that the patient meet the American Psychiatric Association’s DSM-5VR definition of mental disorder, which meant without such diagnosis, CBT for chronic pain was denied).
  163. Medicare Learning Network, Behavioral Health Integration, https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/BehavioralHealthIntegration.pdf (last accessed Feb. 28, 2020).
  164. Carvalho, E. et al., Insurance Coverage, Costs, and Barriers to Care for Outpatient Musculoskeletal Therapy and Rehabilitation Services, 78 N.C. Med. J. 1, 1 (2018).
  165. A Medicare Part B participant pays 20% of the Medicare-approved amount, meaning the patient is responsible for the provider’s charge over the amount that Medicare approves. The Medicare deductible also applies.  Importantly, though, the annual cap on coverage has been lifted. Medicare, Your Medicare Coverage – Physical Therapy, https://www.medicare.gov/coverage/physical-therapy.
  166. For example, Blue Cross of Minnesota indicates that some of its health plans cover acupuncture when it is medically necessary and prescribed by the patient’s doctor. The doctor can prescribe acupuncture for chronic pain when it has lasted for a period of at least six months and “did not respond to more conservative forms of treatment, like drugs or physical therapy” (emphasis added). Blue Cross and Blue Shield of Minnesota, Acupuncture: What does health insurance cover?, https://www.bluecrossmn.com/health-plans-101/acupuncture-what-does-health-insurance-cover.
  167. This grant was awarded as part of the NIH HEAL Initiative.  https://grants.nih.gov/grants/guide/rfa-files/RFA-AT-19-005.html
  168. CMS Coverage Database, Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N), Centers for Medicare and Medicaid Services (Jan. 21, 2020), https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=295.
  169. Id. at 3.
  170. HHS, in its mission “to enhance and protect the health and well-being of all Americans,” provides health-related services and fosters advances in public health and medicine. HHS and the federal agencies that fall under its umbrella (like CMS, the CDC, and Health Resources and Services Administration (HSRA)) can in their individual capacities as agencies take steps to create a workable infrastructure for facilitating the treatment of chronic pain.  HHS also works closely with state and local governments, providing funding for program operations. Through contingent funding from the federal government, HHS can, via initiatives similar to the research and outreach programs for the opioid crisis, take steps to address chronic pain. See Assistant Secretary for Public Affairs, About HHS, U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES https://www.hhs.gov/about/index.html (last accessed Feb. 26, 2020). 
  171. See U.S. Const. amend. X (reserving “the powers not delegated to the United States by the Constitution, nor prohibited by it to the States, . . . to the States respectively, or to the people.”).
  172. See Hoagland et al, supra n. 45 at 13 (referencing funding to address the opioid crisis administered by SAMHSA, for the STR and SOR grant programs to address access to treatment for opioid misuse). 
  173. Richards, E., State versus Federal Powers -- The Regulation of Commerce, The LSU Medical and Public Health Law Site 1, 1 (2009) (referencing Dean Milk Co. v. Madison, 340 U.S. 349 (1951)). 
  174. NFIB v. Sebelius 567 U.S. 519 (2012) also sheds light on how to implement this program. The Supreme Court, in reviewing the Medicaid expansion provision of the Patient Protection and Affordable Care Act of 2010 found that the conditions on federal funding  exceeded Congress’s spending power because it was impermissibly coercive and otherwise intruded on the role of the states in the federalist system and the delegation of the power over medicine to the states. The court reasoned, among other things, that Congress can tell states that accept funding how to comply but cannot penalize states that do not comply by taking away all Medicaid funding. This is distinguishable from the funding program proposed in this article because this is for states that provide access to alternative treatments, and separate and distinct from the current Medicare and Medicaid framework.
  175. See generally South Dakota v. Dole,  483 U.S. 203, (1987) (withholding a percentage of highway funding from states that failed to raise the drinking age to 21).
  176. Assistant Secretary for Public Affairs, HHS Organizational Chart, U.S. Department of Health & Human Services (Nov.14, 2018), https://www.hhs.gov/about/agencies/orgchart/index.html.
  177. See Women's Health and Cancer Rights Act (WHCRA), The Department of Labor,  https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/publications/your-rights-after-a-mastectomy.pdf (signed into law to mandate that group health plans, insurance companies, and health maintenance organizations (HMOs) provide reconstructive surgery insurance coverage after a mastectomy for breast cancer and prohibit limitations on breast cancer patients’ hospital stays. How the coverage is regulated depends on whether the insurance is sponsored by a private employer (regulated by the Department of Labor), or state or local governmental employers (regulated by CMS, for the purposes of WHCRA). This law does not apply to Medicare or Medicaid participants, but Medicare covers reconstruction after mastectomies due to breast cancer, and Medicaid coverage varies by state. Health Insurance Laws, Women’s Health and Cancer Rights Act, American Cancer Society (May 13, 2019), https://www.cancer.org/treatment/finding-and-paying-for-treatment/understanding-health-insurance/health-insurance-laws/womens-health-and-cancer-rights-act.html.
  178. See generally Task Force Report, supra n. 92, at 1-116.
  179. Id. at 46.
  180.  Id. at 51.
  181. Id. at 71.
  182.  Id.
  183.  Id. at 62.
  184.  Id. at 40.
  185.  Id. at 71.
  186.  Id.
  187. Id.
  188.  Id.  Unlike prescribing pharmacological treatments for chronic pain (which under state regulations often cannot be e-prescribed via telehealth because of an important requirement of an in-person examination due to the drug’s classification), healthcare providers could instead prescribe evidence-based alternatives through a telehealth program if the coverage for telehealth services is expanded to encompass evidence-based alternative therapies.  States with telehealth parity laws mandate private payor reimbursement for telehealth visits at the same rate as in-person visits.  A national framework for coverage of evidence-based alternatives would be an effective solution here. Additionally, the SUPPORT Act expanded telehealth services for treatment of opioid use disorder. Where telehealth services for Medicare Part B participants originally followed Social Security Act (SSA) Section 1834(m) requirements, the SUPPORT Act  expanded access beyond the limitations that the originating sites must be located in a rural health professional shortage area or a county not included in a Metropolitan Statistical Area.  See Medicaid Learning Network, Telehealth Services, https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/TelehealthSrvcsfctsht.pdf (last accessed Feb. 28, 2020) (adding the “home” as a form of CMS “Telehealth Services” in specific instances).
  189.  Koele, supra n. 135, at 210.
  190.  Seminowicz, supra n. 62, at 10.
  191. Sun, supra n. 72, at 5.
  192.  MacPherson & Vertosick, supra n. 82, at 5.
  193.  Position Statement, American Academy of Pain Medicine, Use of Opioids for the Treatment of Chronic Pain (Mar. 7, 2013), https://painmed.org/about/position-statements/use-of-opioids-for-the-treatment-of-chronic-pain.
  194.  Id. at 3.
  195.  Id. at 1.
  196.   Varley, A., et al., Assessing Barriers and Facilitators to the Uptake of Best Practices for threating Co-Occurring Chronic Pain and Opioid Use Disorder, Poster at the 11th Annual Conference on the Science of Dissemination and Implementation in Health (December 3-5, 2018).
  197.  Id. at 1.
  198.  Penney, L. S., et al., Provider and patient perspectives on opioids and alternative treatments for managing chronic pain: a qualitative study, 17 BMC Family Practice 164, 170 (2016).
  199.   Varley, supra n. 196, at 1.
  200.     Penney et al., supra n. 198, at 171.
  201.   Id. at 174.
  202.    Tan, G., et al., Efficacy of selected complementary and alternative medicine interventions for chronic pain, 44 J. Rehabil. Res. Dev. 195, 210 (2007).
  203.    Walker, T., Study Reveals Insurers Could Do More to Cover Opioid Alternatives, Managed Health Care Exec. (Oct. 14, 2018), https://www.managedhealthcareexecutive.com/pharma-forecast-report/study-reveals-insurers-could-do-more-cover-opioid-alternatives.
  204.    Lopez, G., White House: the opioid epidemic cost $2.5 trillion over 4 years, Vox Media (Nov. 1, 2019), https://www.vox.com/policy-and-politics/2019/11/1/20943599/opioid-epidemic-cost-white-house-economic-advisers.
  205.    Id. at 715.
  206.    Tick et al., supra n. 103, at 179.
  207.   Tick et al., supra n. 103, at 197.
  208.   Id. at 187. 
  209.    Kennedy, A., et al., Support for self-care for patients with chronic disease 335 British Med. J. 1, 3 (2007), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2071971/.
  210.   Cleveland Clinic, Chronic Pain Management and Treatment, https://my.clevelandclinic.org/health/diseases/4798-chronic-pain/management-and-treatment. (last accessed Nov. 26, 2019).
  211. Bernstein, supra n. 1, at 5.
  212. Id. at 5.
  213. Id

About the Author

Stephanie L. Flackman is a third-year law student at Seton Hall University School of Law and a part-time Law Clerk at Ice Miller LLP in the firm’s Business Group. Ms. Flackman is the recipient of the 2020 American Bar Association Health Law Section Law Student Writing Competition Award. Between completing her undergraduate studies in Neuroscience and Public Health and working as a paralegal for a broker-dealer regulated by the SEC and FINRA prior to law school, Ms. Flackman became passionate about the intersection of medicine and the law.  She hopes to have the opportunity to pursue pro bono work in the area of health law as a future lawyer. She also hopes her article starts conversations about the present state of patients suffering from chronic pain and how to improve their quality of life in a meaningful way. She may be reached at sflackman@gmail.com.