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Two Carey Law Faculty Study Impact of Laws and Government Policies on Pain Patients

While most readers might not think of law school faculty as playing a role in advancing chronic pain research, two faculty members at the University of Maryland Carey School of Law have devoted a significant portion of their time and scholarship looking at the impact of state and federal laws, regulations, and practices on the ability of individuals with chronic pain to receive appropriate treatment.

Some of this work has also led to novel insights about our evidence, tort and criminal laws, as well as laws regarding medical practice and the prescribing of controlled substances, in addition to Medicare and Medicaid policies.

In this issue of the CACPR newsletter, we share the scholarship and advocacy efforts of two Maryland Carey Law faculty members.
Professor Diane Hoffmann Advocates for Responsible Pain Treatment Policy

In all of the debate surrounding the opioid epidemic, an important segment of the population is often forgotten: patients suffering from chronic pain for which opioid medication remains the only effective treatment.

Diane Hoffmann, professor and director of the Law and Health Care Program at the University of Maryland Carey School of Law, and member of the CACPR Executive Committee, has a longstanding research interest in the treatment of chronic pain. In 1997, Hoffmann was named a Mayday Scholar by the Mayday Fund, an organization dedicated to alleviating the incidence and consequence of chronic pain. As a result of that award, she has been able to examine the issue in depth and make important contributions to the literature regarding legal obstacles to the treatment of pain and differences in pain treatment based on gender. Her article, “The Girl Who Cried Pain,” has been widely cited in the literature regarding sex and gender differences in pain response and treatment.

Hoffmann continues to examine the impact of the latest policy developments resulting from the opioid epidemic. In fall 2017, she presented her research during the Pain Grand Rounds in the Department of Neurology and Neurosurgery at the Johns Hopkins School of Medicine. In her talk, “Legal and Ethical Challenge to the Treatment of Chronic Pain Patients,” Hoffmann reviewed the collateral damage of attempts to address the issue of opioid overprescribing in the 1990s and early 2000s, namely disciplinary and prosecutorial actions against physicians treating chronic pain patients with high doses of opioids. In some cases, this led to inappropriate jail time for physicians, and the cases were later overturned on appeal. These judgments were due in part to a lack of understanding of chronic pain treatment by federal agencies and state licensing boards responsible for oversight of physicians. Indeed, these entities have struggled to establish and enforce a consistent standard for opioid prescriptions.

At the same time, there has been considerable pressure for state and federal agencies to respond to the rapid increase in rates of opioid misuse and abuse and opioid overdose deaths. As a result, in 2016, the CDC issued a guideline for prescribing opioids to treat chronic pain. The guideline emphasizes the importance of prescribing only when necessary, at the lowest dose and for the shortest duration possible, and only in the context of close patient monitoring. It also recommends that primary care physicians should avoid increasing dosages to more than 90 morphine milligram equivalents (MME) per day or to “carefully justify a decision” to increase dosages above that amount.

Although the guideline was designed to provide only guidance, it has served as a basis for legislative action in many states including efforts to limit the dosage and quantity of opioid prescribing. Some statewide Medicaid programs have adopted the CDC guideline as a standard or set other MME-per-day limits on what they will cover for Medicaid enrollees. The DEA has also stepped up its enforcement, with a significant increase in the number of administrative actions against physicians to remove their registration to prescribe controlled substances as well as criminal prosecutions.

“I think it’s clear now, in hindsight, that the pendulum swung too far in the direction of liberalization of opioid prescribing. Now I fear the pendulum is swinging too far in the direction of restrictiveness,” said Hoffmann. “In the effort to combat the opioid epidemic, state and federal authorities, as well as physicians fearing the strong arm of the law, are depriving patients of an appropriate and effective treatment for chronic pain.”
In the effort to combat the opioid epidemic, state and federal
authorities, as well as physicians fearing the strong arm of the
law, are depriving patients of an appropriate and effective
treatment for chronic pain."
— Diane Hoffmann
Hoffmann has expressed these concerns publicly, in a co-authored letter to the editor of the Washington Post , as well as in a recent article on Stat News.

As she and coauthors Kate Nicholson and Chad Kollas note, legal and regulatory action focused on prescription opioid use and the resulting forced tapering or abandonment of patients by physicians may lead some pain patients to seek opioids through illegal means, increasing the risk of overdose. Professional associations such as the American Medical Association have similarly advised caution. Late last year, the AMA passed resolutions arguing against inappropriate use of the CDC Guideline by “pharmacists, health insurers, pharmacy benefit managers, legislatures, governmental and private regulatory bodies” including the use of the dosage guidelines alone as the basis for discipline of physicians.

Hoffmann hopes that state and federal policymakers will realize the harm that some of the recent laws and policies are causing and make efforts to change those laws as soon as possible.

Hoffmann is also on the board of For Grace, a non-profit advocacy organization in Los Angeles, Calif., established to increase awareness and promote education of the gender disparity women experience in the assessment and treatment of their pain and to improve pain treatment for all chronic pain patients.

In November 2018, Hoffmann spoke at the organization’s California Pain Summit about how the current opioid crackdown is playing out in California and other states, and outlined steps the state might take to improve care of chronic pain patients. She is continuing to work with For Grace to develop policy options that may result in changes in state laws. Planning for a second Pain Summit in Sacramento is also underway.
Professor Amanda Pustilnik’s Scholarship On Pain Informs Emerging Policies Around Pain and Disability

The role of neuroscience in measuring pain has been a longstanding focus of Professor Amanda Pustilnik’s scholarship. Her scholarship has examined the use of neuroimaging technologies to measure pain in the legal context, highlighting the limitations of such technologies in providing accurate assessments of individual pain experience.

In 2014, along with Prof. David Seminowicz, a member of CACPR's Executive Committee, Pustilnik organized a symposium at the law school, “Imaging the Brain, Changing Minds: Chronic Pain Neuroimaging and the Law,” that brought together legal academics, pain neuroimaging researchers, policymakers, and judges, to discuss the latest developments in the field of neuroimaging with regard to chronic pain. The roundtable resulted in a dedicated issue of the  Journal of Health Care Law and Policy .

Since 2015, Pustilnik has continued her research and scholarship in this area. Her collaborations with scientists on brain imaging of pain led to her recent work on opioids on behalf of the Aspen Institute, resulting in a book chapter on “The Law’s Responses to the Opioid Epidemic: Legal Solutions to a Unique Public Health, Criminal Law, and Market-Related Crisis” in  Confronting Our Nation’s Opioid Crisis: a Report of the Aspen Health Strategy Group  (2017). In 2017, Pustilnik also contributed to a series of articles on brain imaging and chronic pain published in  Nature Reviews Neurology  and  Harvard Review of Psychiatry.

Recently, Professor Pustilnik was able to turn her scholarship into practical application. In collaboration with colleagues from the Center for Law, Brain, and Behavior at Massachusetts General Hospital, where she holds an appointment, along with numerous scientists studying pain, she was the lead writer for comments submitted to the Social Security Administration regarding the assessment of chronic pain in the disability determination process. Signatories include Law and Health Care Program faculty members Leslie Meltzer Henry and Diane Hoffmann as well as Drs. Susan Dorsey, Joel Greenspan, Richard Traub and David Seminowicz, members of the CACPR Executive Committee.
In order to qualify for Social Security disability benefits (SSDI), the Social Security Administration (SSA) must determine whether the applicant is eligible to receive benefits based on:
  • Their ability to engage in work.
  • The medical severity of their impairments.
  • Their functional capacity to engage in work.

As part of this assessment, SSA considers:
  • The medical evidence supporting the claim of disability.
  • The individual’s description of symptoms, including pain.
In December 2018, SSA published an advance notice of proposed rulemaking (ANPRM), “Consideration of Pain in the Disability Determination Process,” and solicited public input to determine whether revisions to the current policy on the evaluation of pain is warranted. 

As outlined in the SSA's ANPRM, the existing regulations involve a two-stage process for evaluating pain. In the first stage , a determination is made regarding whether there is objective medical evidence  of an impairment that could reasonably be expected to cause pain . If this criterion is met, the claim moves to the second stage of the evaluation process. In the second stage , the intensity and persistence of pain is evaluated based on the evidence in the record. 

The Social Security Disability Regulations were drafted in 1984, well before the science regarding chronic pain began to shed light on the underlying mechanisms and features of these conditions. 

In the comment, Pustilnik and colleagues discuss the scientific advances in the understanding of chronic pain, supplanting the prior prevailing model that mirrored the acute pain model of an identifiable stimulus resulting in the experience of pain. Current scientific understanding of chronic pain disorder recognizes these pain disorders as independent medical entities that may or may not be related to a physical injury. Researchers now recognize that chronic pain disorders involve neurological mechanisms among others (e.g. dysfunctional immune activation, epigenetic and genetic factors, and the microbiome). 

The current determination process, however, fails to take these factors into consideration. In the comment, Prof. Pustilnik and colleagues argue that applications involving chronic pain disorders should take advantage of existing clinical tools that can more accurately assess an individual’s chronic pain condition.

Similarly, the comment authors argue that regulatory requirements that pain be proportionate to the injury or disease are also outdated and contrary to current scientific understanding. As they note, the pain experienced by individuals with chronic pain disorders is inherently disproportionate to identifiable factors and often occur in the absence of an identifiable cause. They recommend that language such as “proportionate” and “subjective” be removed from the regulations.

When disability denials are appealed, the claims often end up in the federal district and appellate courts, which have developed their own standards for evaluating claims involving pain. The commenters note that the U.S. Court of Appeals for the Fifth Circuit and, in some cases, other Circuits have adopted a standard that chronic pain only meets the definition of disability if the pain is “constant, unremitting, and wholly unresponsive to therapeutic treatment.” However, the accepted biomedical understanding is that variability is an inherent characteristic of pain. As a result, the authors argue, this standard favors fraudulent claims. To address this issue, the authors recommend that SSA develop guidance on chronic pain conditions, including key features of chronic pain disorders, to inform examiner and judicial decision-making. 

In current practice, agency examiners penalize applicants who engage in moderate exercise and social engagement, citing these activities as evidence of lack of disability. These determinations, however, run counter to prevailing treatment recommendations that such activities are beneficial to recovery. Research studies of chronic lower back pain, for example, have found that mild activity such as walking and physical therapy results in better outcomes than medication or surgical approaches. In addition, social isolation is predictive of greater pain intensity, cognitive impairment and poorer outcomes among individuals experiencing pain. The commenters recommend that SSA promulgate guidance to help examiners assess whether an individual’s activity and social interaction is appropriate and supportive of their recovery versus activity that may undermine the veracity of the claim.

In its efforts to determine whether an individual meets statutory definitions of disability, there has been significant emphasis placed on imaging tests such as CT, MRI and X-ray. Pustilnik and colleagues point out that such tests have limited utility in determinations involving chronic pain disorders given the frequent absence of anatomical abnormalities and the current understanding that some of these conditions are disorders of central nervous system sensitization. Imaging tests are of little utility in such cases and may also lead to inappropriate medical procedures that are unlikely to remedy the experience of pain.

The comment authors also caution against the adoption of fMRI- or EEG-based pain measurement devices as standard practice in evaluations, an argument Prof. Pustilnik and colleagues made in a 2017 publication in  Nature Reviews Neurology . As the authors note, there are significant challenges associated with brain-based pain measurement. First, current technologies have only been proved reliable in detecting acute pain. Second, even if the technology advances so that these techniques can be employed to assess chronic pain, pain detection is a limited marker of the overall condition and should not be the primary factor in a disability determination. Third, pain experience varies over time and testing may occur during a period of low pain intensity that does not accurately reflect an individual’s pain experience. The authors also highlight the lack of standardized protocols and established error rates.
Pustilnik’s comments illustrate the benefit that multidisciplinary collaboration can have on advancing chronic pain research and treatment goals. Pustilnik is hopeful that the comments will lead to changes in SSA policy on chronic pain and result in more appropriate determinations about whether an individual should receive SSDI.
New Publications and Presentations
Colloca, Luana
Department of Pain and Translational Symptom Science, Department of Anesthesiology

Honzel E, Murthi S, Brawn-Cinani B, Colloca G, Kier C, Varshney A, Colloca L. 
approach to pain management . Pain. 2019 Feb 25. [Epub ahead of print] PubMed PMID: 30817437.

Palese A, Cadorin L, Testa M, Geri T, Colloca L, Rossettini G. Contextual
a national cross-sectional study . J Clin Nurs. 2019 Jan 31. [Epub ahead of print] PubMed PMID: 30706543.
Dorsey, Susan
Department of Pain and Translational Symptom Science, Department of Anesthesiology

Dorsey SG, Kleckner IR, Barton D, Mustian K, O’Mara A … Janelsins MC (2019). NCI Clinical Trials Planning Meeting for prevention and treatment of chemotherapy-induced peripheral neuropathy J Natl Cancer Inst, Jan 31 . PMID: 30715378. 
Greenspan, Joel
Department of Neural and Pain Sciences

Miller VE, Poole C, Golightly Y, Barrett D, Chen DG, Ohrbach R, Greenspan JD, 
Mar;20(3):288-300. Epub 2018 Oct 4. PubMed PMID: 30292793.

Smith SB, Parisien M, Bair E, Belfer I, Chabot-Doré AJ, Gris P, Khoury S, Tansley S, Torosyan Y, Zaykin DV, Bernhardt O, de Oliveira Serrano P, Gracely RH, Jain D, Järvelin MR, Kaste LM, Kerr KF, Kocher T, Lähdesmäki R, Laniado N, Laurie CC, Laurie CA, Männikkö M, Meloto CB, Nackley AG, Nelson SC, Pesonen P, Ribeiro-Dasilva MC, Rizzatti-Barbosa CM, Sanders AE, Schwahn C, Sipilä K, Sofer T, Teumer A, Mogil JS, Fillingim RB, Greenspan JD, Ohrbach R, Slade GD, Maixner W, Diatchenko L. Genome-wide association reveals contribution of MRAS to painful temporomandibular disorder in males . Pain. 2019 Mar;160(3):579-591. PubMed PMID: 30431558; PubMed Central PMCID: PMC6377338.
Hogans, Beth B.
Johns Hopkins School of Medicine, Department of Neurology
Beth Hogans has been elected to serve as chair of the International Association for the Study of Pain's (IASP) Pain Education Special Interest Group, effective March 2019.

About IASP
IASP (International Association for the Study of Pain) is a global non-governmental organization that "brings together scientists, clinicians, health-care providers, and policymakers to stimulate and support the study of pain and to translate that knowledge into improved pain relief worldwide."

Contact Beth if you would like to share information about developments in pain education locally, or if you would like to contribute news or a story to the IASP's Pain Education newsletter.
Beth Hogans' most recent talks:

Low Back Pain and the Older Adult: Evidence for low back conditions as causative and moderating effects of affective disorders, widespread pain, and BMI. Geriatric Research Education Clinical Center lecture series, VA Maryland Health Care System. January 17, 2019.

Non-opioid pain management in primary practice: the Role of patient education in patient-centered care. American Medical Association/Telligen QIN-QIO Webinar series on Pain Management. December 12, 2018.

Non-opioid pain management in primary practice: the Convergence of translational science and patient-centered care. Medicine Grand Rounds, University of Maryland School of Medicine, Baltimore, MD. November 14, 2018.

2018: The IASP Global Year for Excellence in Pain Education. Blaustein Pain Grand Rounds, Johns Hopkins School of Medicine. October 12, 2018.

Innovative Teaching Strategies for the Pain Educator. Interprofessional Workshop presentation. International Association for the Study of Pain. Boston, MA. September 15, 2018.
CACPR Member Spotlight
University of Maryland School of Pharmacy

On Feb. 12, 2019, Andrew Coop, PhD, professor in the Department of Pharmaceutical Sciences and associate dean for academic affairs at the University of Maryland School of Pharmacy, testified before the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) as part of a hearing titled “Managing Pain During the Opioid Crisis.” His testimony emphasized the need for alternative pain management treatments and examined how pharmacists can help ensure that patients who use opioids do so safely and effectively. Learn more.

In 1996, UMB recognized the importance of chronic pain as a significant health problem and established the Organized Research Center (ORC) for Persistent Pain in the School of Dentistry (SOD).

In its June 2011 report, “Relieving Pain in America,” the Institute of Medicine documented that at least 100 million U.S. adults suffer from common chronic pain conditions, with national annual costs and lost productivity estimated to be in the range of $560 billion to $635 billion. In recognition of this greater need, UMB President Jay A. Perman, MD, established the Center to Advance Chronic Pain Research as a Universitywide organized research center.