The Strengths and Weaknesses of Current US Policy to Address Pain

Abstract

Pain is a significant public health problem that needs policy at the national and local level to resolve incidents of insufficient, ineffective, and disparate pain treatment while limiting the risk of inadvertently increasing the use of treatment such as opioids that can result in public harm.

The National Pain Strategy serves as the first comprehensive approach to address pain and provides a roadmap with substantial broad and specific policy implications. Although much has been accomplished to date, transitions in political power, available data and funding, and the current opioid epidemic continue to have an impact on implementation of the National Pain Strategy.

A sustained, coordinated effort with multipronged policies in many forms on both federal and state levels via regulations, laws, and guidelines is warranted. However, research is needed to evaluate the impact and potential unintended consequences of increased legislation and regulation. Nevertheless, policy related to the management of pain may provide the path to new treatments and models of care to reduce the impact of pain as a public health crisis in this country.

Pain is unique in that it is a highly subjective experience with biological, psychological, and social dimensions. The burden of pain reduces quality of life and imparts high socioeconomic and health care costs. Pain treatment necessitates self-care and frequently utilizes specialists in a number of disciplines.¹ Furthermore, limited understanding of pain and shortcomings of available treatments in an era of limited resources highlight the need for effective policies to address pain. Pain policy has a substantial impact on US residents given that tens of millions of people suffer from various types of pain (including acute pain, chronic pain, or pain at the end of life) on a daily basis.² As a public health problem, pain needs policy at the national and local level to balance insufficient, ineffective, and disparate pain treatment with the reality of inadvertently increasing use of controlled substances, namely opioids, resulting in public harm.³

Policy in the United States is enacted in many forms on both federal and state levels via regulations, laws, and guidelines.³ As such, all branches of the federal government have played roles in developing pain policy. Until recently, federal policy did not provide a comprehensive approach to pain management, and a substantial extent of policy was formed primarily at the state level.⁴ However, in 2010, the National Institutes of Health (NIH) contracted with the National Academy of Sciences (NAS), Institute of Medicine (IOM), now termed the National Academy of Medicine (NAM), to study and make recommendations to increase the recognition of pain as a significant public health problem. The resultant National Pain Strategy (NPS)⁵ replaced noncohesive policy responses from the 1990s through the early 2000s with a national integrated and multifaceted roadmap with both broad and specific policy implications. The scope of this article will primarily address and critique the NPS and comment on overlapping and potential competing national policies intended to combat the opioid epidemic.

A LESSON IN HISTORY

The initial involvement of the federal government in pain policy was the regulation of a quintessential aspect of pain treatment: controlled substances. Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, also known as the Controlled Substances Act (CSA), was enacted by Congress in 1970. The CSA was one of several pieces of legislation designed to regulate possession, use, manufacturing, control, enforcement, and classification of certain controlled substances. The CSA initially began as a mechanism to consolidate and clarify the existing patchwork of legislation while providing more support for research and treatment. In addition, the CSA validated opioid medications as necessary components in the treatment of pain. However, over time, amendments and alterations added in the setting of growing concern for drug abuse led to much more stringent and punitive laws in the decades to come.^6,7

During the 1980s and 1990s, several case studies and special interest and advocacy groups responded to the restriction on opioid use solely for treatment of cancer-related pain and pushed for a broader use in noncancer chronic pain.^8–10 As a result, a significant shift in policy occurred at both the state and the federal level to correct for the alleged inadequate treatment of chronic pain. This ultimately led to less restrictive regulation of prescribing on a state level by easing repercussions toward providers and also encouraged initiatives against neglecting pain treatment on a national level.¹¹ Enterprises aimed at increasing the visibility, measurement, and treatment of pain include The Joint Commission accreditation pain standards and the Centers for Medicare and Medicaid Services (CMS) value-based incentive program. These programs, driven in part by use of the Hospital Consumer Assessment of Healthcare Providers and Systems, along with aggressive pharmaceutical marketing campaigns, fueled a dramatic increase in the prescription of opioids.^12–14

The numbers are staggering; in 2012 alone, 259 million prescriptions were written for opioid pain medications, enough for every adult in the United States to have a bottle of pills.¹⁵ The challenges and unintended consequences resulting from previous efforts demonstrated the inherent complexity associated with developing an enduring pain policy and emphasized the need for a cohesive and well-examined national pain strategy. Simultaneously, the substantial media coverage and increased public awareness of the opioid epidemic shifted the national attention away from the treatment of chronic pain.

RESPONSE FROM THE NATIONAL ACADEMY OF MEDICINE

As a component of the NAS, the NAM (previously IOM) works to provide evidence-based research and recommendations for public health and science policy. In 2010, the Affordable Care Act required the Department of Health and Human Services (HHS) to utilize the IOM to address pain as a public health issue. Broad representation from relevant public and private organizations, health care providers, insurers, and people with pain and their advocates were brought together to initiate an effort that would result in the long-term cultural transformation in how pain is perceived, assessed, and treated. The resultant 2011 report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research¹⁶ provides 16 recommendations for improvements in (1) data collection and reporting; (2) availability and effectiveness of pain care; (3) public, patient, and professional education about pain; and (4) relevant basic, translational, and clinical research. In response to this report, the assistant secretary for health at HHS tasked the Interagency Pain Research Coordinating Committee (IPRCC) to develop and implement the NPS with specific goals and clear deliverables.¹⁷

A NATION COMES TOGETHER

The NPS working group and oversight panel members were brought together from analogous stakeholders represented in the IOM report. The overarching objective of the NPS was to decrease the prevalence of pain and reduce its associated morbidity. Released in 2016, the NPS focused on 6 primary areas for improvement:

1. population research,

2. prevention and care,

3. disparities,

4. service delivery and payment,

5. professional education and training, and

6. public education and communication.^5,16

According to the NPS, this approach was to be facilitated by “epidemiologic, health services, social science, medical informatics, implementation, basic, translational, and clinical research informed by clinician/scientist interactions.”^5(p7) The NIH Office of Pain Policy also coordinated activities to develop a Federal Pain Research Strategy,¹⁸ which, under IPRCC oversight, guided strategic research planning and supported funding decisions to fill crucial gaps in pain research. This strategy is aligned with the NPS agenda for developing physiological, clinical, behavioral, outcomes, and health services research. The NPS represents a significant transition in US pain policy from previously disjointed efforts to a cohesive public health approach to pain prevention and care.

To date, a number of critical first steps^19,20 to implement the NPS have occurred including the following:

• publication and endorsement of a set of core pain competencies for prelicensure interprofessional education;

• development of training materials and curricula for primary care pain providers and communication aids for patients, behavioral health, and opioid treatment directories;

• pilot studies to assess coverage policies and parameters for treatment of low back pain; and

• a series of population-level studies on pain prevalence, pain-related disability, and use of services.

Another area of progress is the realization of the Centers of Excellence for Pain Education program and resultant repository of Web-based educational modules aimed at transforming health sciences pain education.²¹ A full list of current initiatives is available at https://iprcc.nih.gov/National-Pain-Strategy/Objectives-Updates. Despite this progress, more needs to be done to ensure sustainable improvement, such as the utilization of standardized electronic health care data methods to determine use, underuse, effectiveness, and costs of pain treatments and services.

EVALUATION OF THE NATIONAL PAIN STRATEGY

The NPS has many strengths compared with previous legislative efforts. Unlike many of its predecessors, the NPS addresses the biopsychosocial aspects of pain previously underrecognized and emphasizes evidence-based and interdisciplinary treatment approaches. The strategy incorporates a public health approach facilitated by a multitude of groups and stakeholders (see the box on the next page) and provides the opportunity to improve quality of care through advancing research. Furthermore, the NPS aligns with the Institute for Healthcare Improvement’s triple aim initiative to improve the patient experience, improve the health of populations, and reduce the per-capita cost of health care. This is accomplished with concrete steps including transformations in education such as the Centers of Excellence for Pain Education program. In addition, the NPS promotes the implementation of value-based, cost-effective models of care (self-managed, interdisciplinary) and associated payment structures such as bundled and performance-based payment.⁵ State-level efforts have also sought to promote these aspects of the NPS with new legislation in support of bundling chronic pain payments²² and state Medicaid coverage of nonopioid-based treatments.²³ Unfortunately, NPS recommendations for coalitions to create extensive public awareness campaigns about pain and safer medication use have not yet been realized. As well, little has been achieved to have a significant impact on payment structures and reimbursement policies.

BOX 1. List of Federal Stakeholders Engaged in National Pain Strategy.

Administration for Community Living (ACL)
Agency for Healthcare Research and Quality (AHRQ)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Department of Defense (DoD)
Drug Enforcement Administration (DEA)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institute for Occupational Safety and Health (NIOSH)
National Institutes of Health (NIH)
National Library of Medicine (NLM)
National Prevention Council (NPC)
Office of Disease Prevention and Health Promotion (ODPHP)
Office of Minority Health (OMH)
Office of the National Coordinator for Health Information Technology (ONC)
Office of the Surgeon General, Regional Health Administrators (OASH)
Patient-Centered Outcomes Research Institute (PCORI)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Veterans Health Administration (VHA)

A major driver of inadequate pain management is incongruent reimbursement policies. Despite a vast body of evidence of the efficacy of many nonopioid,²⁴ interdisciplinary care,²⁵ and self-management interventions,²⁶ payers often cover more expensive medical interventions even when evidence reveals little benefit.²⁷ The vast body of literature on the efficacy of noncovered treatments for chronic pain has had insufficient influence on policymaking. This lack of willingness to cover nondrug and nonmedical treatments contributes to the lack of providers who are knowledgeable and willing to provide these services for people with chronic pain, and access to noncovered treatments can be especially limited in rural areas.²⁸

Nevertheless, challenges to the successful implementation of the NPS exist. The broad nature of the strategy relies heavily on the continued efforts and collaborations of different partners for its success. As such, initiatives assigned to various workgroups in the strategy are progressing at different rates. For example, substantial headway has been made within the workgroups focusing on professional education and training and population research, while other workgroups, including those related to reimbursement, have made less progress. Furthermore, much of the report requires the development of new treatment modalities utilizing new data still in preliminary stages, the details of which are still being constructed by the Federal Pain Research Strategy. The NPS also offers little guidance on acute pain or pain at the end of life. Additional barriers to enactment of the strategy include the absence of a definitive timeline and limited appropriation of funding.

So, although the NPS has far-reaching policy implications that address many of the issues facing the treatment of pain, its success will be largely predicated on the ability of its workgroups to meet the stated deliverables. A number of threats to successful execution of the NPS exist, not the least of which include competition for resources and political attention drawn toward the opioid epidemic. A more comprehensive analysis of the strengths, weaknesses, opportunities, and threats associated with the NPS is outlined in (see the box on the next page).

BOX 2. Strengths, Weaknesses, Opportunities, and Threats Analysis of National Pain Strategy.

Strengths	Weaknesses
• Comprehensive call to action for biopsychosocial approach using integrated interdisciplinary care for population health grounded in scientific evidence	• Data are lacking on prevalence, onset, course, and impact on outcomes of pain treatments
• Public health approach to prevention and care facilitated by epidemiologic, health services, social science, medical informatics, implementation, basic, translational, and clinical research informed by clinician and scientist interactions	• Federal Pain Research Strategy coordination of the federal research effort in alignment with the NPS remains preliminary
• Aligns with the Institute for Healthcare Improvement’s triple aim: to improve the patient experience, improve the health of populations, and reduce the per-capita cost of health care	• Focus on chronic pain with little emphasis on prevention, acute pain, or pain at end of life
• Emphasis on core competencies, team-based care, and transformation in payment models	• Limited appropriation of funding to implement the NPS
• Engaged federal agency stakeholdersa
Opportunities	Threats
• Capacity to gather information electronically in the United States (e.g., to develop registries to evaluate, compare, and assess therapies for quality and value)	• Competition for resources and attention on opioid use disorder, overdose, and death in the nation in context of dual crisis of pain leading to policies that may oversimply and focus on reducing supply of opioids
• Development of more effective and safer pain treatments	• People with pain need an individual treatment approach29
• New models for team-based care and care coordination	• Real-life time constraints of providers to spend necessary time with individual patients
• Payment structure reform aimed at patient outcomes	• Significant barriers exist for necessary collaborations
• Context of dual crisis of pain and opioid epidemic increases engagement of stakeholders to coordinate and balance policy details	• Additional problems fuel vulnerabilities to pain and disparities in care
• Refinement of taxonomy, diagnostic criteria, and International Statistical Classification of Diseases and Related Health Problems nomenclature for pain	• Health literacy of nation
	• Bias, discrimination, and stigmatization of persons with pain
	• Limited coordinated research network and competition for research funding inhibiting collaborations
• Integration of interdisciplinary core competencies in prelicensure education, professional licensure examinations, and educational accreditation standards	• Current payment practices complicate use of integrated, interdisciplinary, team-based care
• Development and validation of quality measures for integrated pain care, outcomes of care, and impact of costs	• Consistency in interpretation of policies and implementation at the state level

Note. NPS = National Pain Strategy.

Source. National Pain Strategy Report: collaborators meeting.²⁹

^aAdministration for Community Living, Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services, Department of Defense, Drug Enforcement Administration, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institute for Occupational Safety and Health, National Institutes of Health, National Library of Medicine, National Prevention Council, Office of Disease Prevention and Health Promotion, Office of Minority Health, Office of the National Coordinator for Health Information Technology, Office of the Surgeon General, Regional Health Administrators, Patient-Centered Outcomes Research Institute, Substance Abuse and Mental Health Services Administration, and Veterans Health Administration.

As prescription opioid and heroin use morbidity and mortality have risen (Figure A, available as a supplement to the online version of this article at http://www.ajph.org), policymakers have turned attention to the issue of narcotic addiction and abuse. Although opioid addiction is inarguably a colossal problem that must be solved, pain and its management must be included in policy solutions to properly address all facets of the problem. Several noteworthy controls that have an impact on pain and addiction policies include payment programs, opioid prescribing guidelines, and regulatory oversight changes.

CENTERS FOR MEDICARE AND MEDICAID SERVICES

In March 2015, HHS issued a brief prioritizing the opioid abuse problem and committed its work toward decreasing opioid overdose and mortality and the prevalence of opioid use disorder. Given that many Medicare and Medicaid beneficiaries and their families experience opioid use disorder, the Centers for Medicare and Medicaid Services (CMS) outlined an accelerated strategy focused on prevention, rescue, and treatment.^30,31 The CMS strategy includes 4 priority areas: (1) implement more effective person-centered and population-based strategies to reduce the risk of opioid use disorders, overdoses, inappropriate prescribing, and drug diversion; (2) expand naloxone use, distribution, and access, when clinically appropriate; (3) expand screening, diagnosis, and treatment of opioid use disorders, with an emphasis on increasing access to medication-assisted treatment; and (4) increase the use of evidence-based practices for acute and chronic pain management. Although objective 4 seeks to improve pain treatment through supporting the increased use of nonpharmacologic therapies, nonopioid analgesics, and multimodal analgesia, the principal focus of the CMS strategy is on opioid use disorder. The priority efforts for pain are to identify noncovered pain treatments with sufficient evidence, much of which is often lacking in the literature, and promotion of provider and beneficiary pain management education, which is a weak intervention for behavioral change.

CENTERS FOR DISEASE CONTROL AND PREVENTION

As an agency of the HHS, the Centers for Disease Control and Prevention (CDC) utilizes funds allotted by Congress to promote health and education. In an effort to combat the aggressively growing opioid epidemic, the CDC published a set of evidence-based best practice guidelines for prescribing opioids in proximity to the NPS in 2016.³² The guidelines are intended for primary care providers who treat adult patients with chronic pain in outpatient settings excluding palliative and end-of-life care. In recognition of how long-term opioid use often begins with treatment of acute pain, the CDC guidelines call for the prescription of both the lowest effective dose and shortest duration of short-acting opioids for acute pain. The CDC also asserts that a 3-day treatment plan is often sufficient for acute pain, and more than 7 days of treatment is rarely needed. Though prescribers are referred to other guidelines for dental pain, perioperative pain, and sickle cell disease, the recommended time limit quantity has led to much consternation in the press and by some patient advocacy groups and has had a direct impact on at least 1 state Medicaid coverage policy.³³

In support of the NPS, the CDC’s guidelines for opioid use recognize the need for chronic pain management, as well as its challenges, and favor a multimodal and nonopioid approach. The opioid guideline “is intended to improve communication between clinicians and patients about benefits and risks of opioids for chronic pain, improve the safety and effectiveness of pain treatment, and reduce risks associated with long-term opioid therapy.”^32(p1) In addition, the CDC also engages in education, data collection, and advocacy but has already requested $85.6 million to combat opioid overdose.³⁴ This further emphasizes the shift of resource allocation away from chronic pain management in favor of opioid use disorder and the resulting sequelae.

PAIN MANAGEMENT AND THE OPIOID EPIDEMIC

Recognizing the need to deploy multiple policy tools to control the opioid epidemic, the US Food and Drug Administration (FDA) asked the NAS to recommend actions that the FDA and other public and private organizations should take to balance society’s interest in reducing opioid-related harm and the needs of individuals suffering from pain. The resultant consensus guidance outlines² recommended strategies for the FDA to help address the opioid epidemic including (1) restricting the lawful supply of opioids, (2) influencing prescribing practices, (3) reducing demand, and (4) reducing harm. Although criminal law was beyond the scope of the report, the need for improved tracking of the dynamic interaction between legal and illegal markets is one of its core themes. The NAS report preface describes a new blurring of the formerly distinct social boundary between use of prescription opioids and the use of heroin and other illegally manufactured drugs as an opportunity to finally reframe the “cops vs docs” debate that has characterized US drug policy since World War II.

As would be expected, much of the detail in the recommendations calls for increased oversight including preapproval of drugs and postapproval surveillance and realignment of reimbursement incentives. However, there is a warning against arbitrary restrictions on access to opioids by persons suffering from pain whose provider has prescribed responsibly. The need for professional, patient, and public education present in previous reports is echoed, though the effectiveness of risk evaluation and mitigation strategies and education programs for extended- release and long-acting opioid analgesics remains questionable.

Of note, the report provides a shift by the FDA away from a product-specific approach to drug approval decisions to incorporate public health considerations into a comprehensive systems approach for regulatory decisions regarding opioids. The report calls for a sustained, coordinated effort with multipronged policies by state and local governments, yet warns that further research is necessary to enable effective and measurable policy interventions. An important implication is the potential collaboration with the CDC and other agencies to develop an explicit data infrastructure model that can better integrate information from different sources and incorporate dynamic processing to assess the public health consequences of different decisions and value judgments.

LEGISLATION AIMED TO QUELL OPIOID EPIDEMIC

In December 2016, HR 6, the 21st Century Cures Act, was passed to increase block grant funding for substance abuse and mental health issues, and, in October 2017, President Donald Trump declared the opioid epidemic a national public health emergency.³⁵ In response, by February 2018, CMS proposed restrictions to the amount of opioids that Medicare beneficiaries could receive in an attempt to reduce the oversupply of opioids in the community. In addition, an aggressive new initiative was announced by the president’s office aimed at cutting nationwide opioid prescriptions by one third within 3 years.³⁶ The Trump initiative issued on March 19, 2018,³⁷ is purported to weave together policies that will address opioid supply reduction, addiction prevention, and treatment. But the plan has been criticized as being largely focused on the criminal justice system, an approach proven to be ineffective in the past. Though the plan includes some provisions to boost federal funding for mental health treatment, no funding numbers or specific details were released and there was no mention of pain.

In a similar light, the Comprehensive Addiction and Recovery Act (CARA), signed by President Barack Obama in 2016, provides legislation to address the opioid epidemic, encompassing all 6 pillars necessary for creating a coordinated response—prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. Although it authorizes more than $181 million each year in new funding to fight the opioid epidemic, the budget must be appropriated every year, even under new leadership.³⁸ In February 2018, senators introduced policy changes to CARA following the increased budget allocation to combat the opioid epidemic for both the 2018 and 2019 fiscal years. The updates to CARA include, among other things, increasing funding authorization, supporting the 3-day time limit quantity in acute pain prescribing supported by the CDC, reduced restrictions on medication-assisted treatment, and harsher penalties for manufacturers contributing to diversion of opioids.³⁹

Additional bills aimed at subduing the opioid epidemic have been introduced in 2018, combating the problem from various angles. HR 4275 is geared toward requiring the Drug Enforcement Administration to aid pharmacists in better detecting fraudulent prescriptions. HR 5401 is designed to increase safe disposal of unused medications. HR 2063 would require continued education for opioid prescribers. These are just some of the many pieces of legislation introduced by early 2018 and are likely the first of many for this year. This plethora of recent legislation illuminates the degree to which the national stage has progressed away from the comprehensive pain strategy championed by the NPS in lieu of a more myopic focus on the current opioid crisis.

Yet, despite the clear message promoting opioid stewardship and the need to address pain coming from HHS, the CDC, National Academies, and other agencies, legislation continues to pass that muddies the waters. As late as 2016, the Ensuring Patient Access and Effective Drug Enforcement Act was passed. This limited the power given to the Drug Enforcement Administration by the CSA to enforce suspensions on drug manufacturers and distributors and illustrated the complicated nature of pain-related policy.⁴⁰

LET NOT THE PERFECT BE THE ENEMY OF THE GOOD

The United States has recognized pain as a substantial public health issue with significant costs. In an effort to manage pain appropriately, policy has shifted significantly over the past 3 decades. The NPS is unlike anything previously attempted to combat pain and its consequences and will continue to shape the development of policy. The current context of dual crises of both the national opioid epidemic and the national pain crisis can serve to increase awareness and mobilize stakeholders on both fronts.

Significant efforts and progress have been made to unify the national approach to transform the culture of pain. Sean Mackey, co-chair of the NPS Report Oversight Committee, has urged those committed to transforming pain care in America not to pick the NPS apart,²⁹ but to support it in its entirety and “let not the perfect be the enemy of the good.” The complexity of pain is enormous, from its personal experience to its context in a dynamic social, economic, and political macro- and microsystem.

Policy is constantly evolving and highly context-specific. It is shaped by transitions in political power, the data at hand, and the circumstances of those it affects, among many other factors. Policy related to the management of pain can change perspectives, provide the path to new treatments, and reduce the burden of disease at a much larger level than individual therapies. As seen recently, substantial effort has been made at the policy level to address the growing opioid abuse epidemic diverting attention and funding away from chronic pain management. While opioid prescriptions have fallen, the harms to pain patients (notably, suicides) and overdose deaths continue to rise, thus reflecting a policy imbalance between strong prescription controls and weak pain and mental health treatment expansion.⁴¹ Although this clearly stands to benefit those impacted by opioid use disorder in the short term, it could potentially delay the advancement of pain management in a broader sense and thus inadvertently prolong the epidemic further.

One of the challenges of policy creation and implementation is the uncertain impact and potential for far-reaching implications unintended at its creation. As such, continued evaluation and assessment of policy effectiveness is essential. US pain policy is at a turning point and the influence of the NPS and other legislation and regulation remains to be seen. Nevertheless, a challenge has been leveled to reduce the impact of pain as a public health crisis in the United States, and new and existing policy will continue to be a driving force behind any success or failure to meet it.