By Terri Lewis, PhD.
Dr. Terri Lewis is a rehabilitation educator, clinician and researcher who specializes in chronic pain and is a frequent contributor to the National Pain Report. Dr. Lewis is writing a series of articles in September that address the big issues facing chronic pain and chronic illness patients. This is her is her second installment, her first installment can be found here.
Let’s Continue to Review the Experiences of Marlene and David-
As we have learned, Marlene, a single 42 year old woman who resides in Indiana, has lost her second leg to an amputation caused by an undetected blood clotting disorder. She has a history of substance abuse but has been free of its’ effects for four years. She presented to her local emergency room for pain related symptoms after experiencing a tearing sensation while lifting her wheelchair in her vehicle, followed by excruciating acute pain. Her first presentation to a local ER resulted in ER personnel conducting an evaluation, then dismissing her to her home and self-care after her immediate injury was labeled as a hematoma with bruising, and after she was labeled as drug seeking based on her prior history. Pain and symptoms progressed however, so Marlene sought crisis care from her local mental health center which, after an assessment for SUDs and suicidal ideation, returned her to an ER in a second hospital. ER number 2 conducted a CT scan but again dismissed her after noting that she had been admitted from the mental health center where she was assessed for suicidal ideal and substance abuse during the course of her brief stay. Moreover, Marlene who has documented pain generating disorders in her medical records, was developing blood clots that formed in her remaining leg from the undefined abdominal hematoma. Two ERs and one mental health assessment later, her health crisis was finally properly identified after a series of miscommunications, documentation errors, and mistakes in reading tests and imaging. Marlene was admitted into the ICU on an emergency basis, where her abdominal bleeding and clots were properly diagnosed, and where ultimately, her remaining leg was removed. After Marlene’s amputations and a brief hospital stay, she was discharged to her home with a 7 day prescription for opiates which her insurer, Humana, refused to authorize because opiates are no longer covered on her dual Medicare, Medicaid policy. Recommended substitutions were contraindicated for her rare blood clotting disorder. Marlene borrowed $400.00 from her family members to obtain 7 days of minimum relief. Her next appointment is on September 26 where she will be evaluated for possible changes to the medication that controls her blood clotting factors. Her aunt is providing close supervision and support.
David, 38, is a young father of three, a five year survivor of the fungal meningitis outbreak. Still suffering from the effects of his exposure to contaminated epidural injections, he has been diagnosed with headaches, photophobia, tinnitus, adhesive arachnoiditis, fibromyalgia, and polyneuralgia. David lives in West Virgina, a state that has agressivly battled opiate addiction. David has been dropped from care by both his primary care physician and his pain management clinic as ‘too complex’ because of his high dose regimen of opiates. Lacking support, he consulted with a neurosurgeon who recommended and installed a pain pump which resulted in 3 unsuccessful surgeries for pump reconfiguration and a blood patch. The CSF leak remains. His daily morphine equivalent dose has been reduced to 40 MME of dilaudid, with no other medication assisted support – insufficient to reduce his pain levels. He is not supported by any oral medications for breakthrough pain. He spends 20 of 24 hours per day in a reclining position in a dark room. Parenting is difficult. Suicidal ideation is real.
The Influence of State Law, Regulation, Location
So we have two very different but similar cases to consider. And as we consider how their intervention has developed, we begin with the basics – how do the definitions codified in state pain laws influence what has happened to the care they have received within their state? State medical boards and legislatures considered a number of guidance documents in responding to the crises within their states – the Federation of State Medical Board (FSMB) recommendations, CDC Guidelines (March, 2016) and their own statistical analyses regarding overdoses, deaths, prevalence of illicit drugs on the streets of their cities, and the numbers of prescriptions for schedule 2 narcotics issued over a period of time.
The FSMB contains a number of definitions related to both pain and addiction.
How these influence the span of treatment design within each individual state is clear. For instance, the FSMB adopts the following definitions of pain –
“Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Chronic pain is a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.”
Indiana has adopted the following definition of chronic pain, omitting the terms pain, acute pain, and intractable pain, or any other definition of pain –
“Chronic pain means a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years. (b) Notwithstanding subsection (a), this section and sections 4 through 10 of this rule shall not apply to the use of opioids for chronic pain management for the following: (1) Patients with a terminal condition. (2) Residents of a health facility licensed under IC 16-28. (3) Patients enrolled in a hospice program licensed under IC 16-25. (4) Patients enrolled in an inpatient or outpatient palliative care program of a hospital licensed under IC 16-21 or a hospice licensed under IC 16-25.”
West Virginia on the other hand, has adopted more inclusive definitions in their state pain regulations which distinguish the functions of pain care and read as follows –
“Chronic pain” means pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months. For purposes of this article, “chronic pain” does not include pain directly associated with a terminal condition. And this, “intractable pain” means a state of pain having a cause that cannot be removed. Intractable pain exists if an effective relief or cure of the cause of the pain: (1) Is not possible; or (2) has not been found after reasonable efforts. Intractable pain may be temporary or chronic.”
To make these definitions usable means that we have to interpret them through information captured during medical interviews. Generally speaking the FSMB definition is somewhat nonspecific and tangled up in making sure that opioid users don’t become addicts, as is the Indiana definition. The West Virginia definition includes not only chronic pain but intractable pain and treatment. It also specifies these terms in relationship to care conditions related to chronicity versus death and dying.
Each of these definitions must be interpreted and applied through a review of medical records and the information gained through evaluation of the patient. Regulations place an emphasis on physician evaluation activities within each state. The FSMB defines evaluation of the patient as follows –
“A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.”
Indiana’s code has adopted a consumer evaluation approach focused on chronic pain in relationship to discerning risk of abuse –
Sec. 4. (a) The physician shall do the physician’s own evaluation and risk stratification of the patient by doing the following in the initial evaluation of the patient: (1) Performing an appropriately focused history and physical exam and obtain or order appropriate tests, as indicated. (2) Making a diligent effort to obtain and review records from previous health care providers to supplement the physician’s under-standing of the patient’s chronic pain problem, including past treatments, and documenting this effort.
(3) Asking the patient to complete an objective pain assessment tool to document and better understand the patient’s specific pain concerns. (4) Assessing both the patient’s mental health status and risk for substance abuse using available validated screening tools.(5) After completing the initial evaluation, establishing a working diagnosis and tailoring a treatment plan to meaningful and func-tional goals with the patient reviewing them from time to time. (b) Where medically appropriate, the physician shall utilize nonopioid options instead of or in addition to prescribing opioids.
West Virginia’s code is focused on risk stratifications –
“Sec. 4. (a) The physician shall do the physician’s own evaluation and risk stratification of the patient by doing the following in the initial evaluation of the patient: (1) Performing an appropriately focused history and physical exam and obtain or order appropriate tests, as indicated. (2) Making a diligent effort to obtain and review records from previous health care providers to supplement the physician’s understanding of the patient’s chronic pain problem, including past treatments, and documenting this effort. (3) Asking the patient to complete an objective pain assessment tool to document and better understand the patient’s specific pain concerns. (4) Assessing both the patient’s mental health status and risk for substance abuse using available validated screening tools. (5) After completing the initial evaluation, establishing a working diagnosis and tailoring a treatment plan to meaningful and functional goals with the patient reviewing them from time to time.
The treatment plan is drawn from the patient evaluation. FSMB states that –
The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
Indiana’s guidance states-
Sec. 3. (a) This section and sections 4 through 10 of this rule establish requirements concerning the use of opioids for chronic pain management for patients. (b) Notwithstanding subsection (a), this section and sections 4 through 10 of this rule shall not apply to the use of opioids for chronic pain management for the following: (1) Patients with a terminal condition. (2) Residents of a health facility licensed under IC 16-28. (3) Patients enrolled in a hospice program licensed under IC 16-25. (4) Patients enrolled in an inpatient or outpatient palliative care program of a hospital licensed under IC 16-21 or a hospice licensed under IC 16-25. However, a period of time that a patient who was, but is no longer, a resident or patient as described in subdivisions (2) through (4) shall be included in the calculations under subsection (c). (c) The requirements in the sections identified in subsection (a) only apply if a patient has been prescribed: (1) more than sixty (60) opioid-containing pills a month for more than three (3) consecutive months; (2) a morphine equivalent dose of more than fifteen (15) milligrams per day; for more than three (3) consecutive months; (3) a transdermal opioid patch for more than three (3) consecutive months; (4) at any time it is classified as a controlled substance under Indiana law, tramadol, but only if the patient’s tramadol dose reaches a morphine equivalent dose of more than sixty (60) milligrams per day for more than three (3) consecutive months; or (5) a hydrocodone-only extended release medication that is not in an abuse deterrent form.
West Virginia’s guidance states-
- 30-3A-2. Limitation on disciplinary sanctions or criminal punishment related to management of intractable pain (a) A physician shall not be subject to disciplinary sanctions by a licensing board or criminal punishment by the state for prescribing, administering or dispensing pain relieving controlled substances for the purpose of alleviating or controlling intractable pain when: (1) In a case of intractable pain involving a dying patient, the physician discharges his or her professional obligation to relieve the dying patient’s intractable pain and promote the dignity and autonomy of the dying patient, even though the dosage exceeds the average dosage of a pain-relieving controlled substance; or (2) In the case of intractable pain involving a patient who is not dying, the physician discharges his or her professional obligation to relieve the patient’s intractable pain, even though the dosage exceeds the average dosage of a pain relieving controlled substance, if the physician can demonstrate by reference to an accepted guideline that his or her practice substantially complied with that accepted guideline. Evidence of substantial compliance with an accepted guideline may be rebutted only by the testimony of a clinical expert. Evidence of noncompliance with an accepted guideline is not sufficient alone to support disciplinary or criminal action.
So, let’s review. Legislatures define the laws and regulations for the dispensing of schedule II narcotics and pain management by licensed clinicians. Boards of Medicine regulate the practice of medicine within their states, not the federal government, and not federal guidance documents. State level regulations and activities are influenced by federal guidance documents, Medicare guidelines, insurance plans, and legislative initiatives. FSMB guidance to state boards of medicine includes very nonspecific language that conflates opioid treatment with substance abuse treatment using terms like dependence, tolerance, and addiction as a basis for treatment evaluation and planning in addition to attention to chronic pain. Indiana’s regulations are also nonspecific but allow for physicians to treat those who have chronic pain and palliative care needs so long as they thoroughly document the need for extensive measures. And West Virginia, which leads the nation in opioid prescriptions, abuse, and overdose deaths, has adopted enabling language that distinguishes between the needs of the chronic care patient, the person who needs palliative care, and the physician’s right to provide treatment.
That said, let’s look at both Marlene and David to consider their needs. First, neither Marlene nor David have a primary care physician. That’s a problem. In both their cases, their primary physicians decided their care needs were too complex and they were red flagged, or discharged – code for high dose opiates make me fear for my practice license, and interference from DEA and CDC. That means there is nobody to consistently coordinate their care. That means their interaction with their systems of care is happenstance and both will rely on the emergency room where things are quite likely to fall apart.
Both Marlene and David receive Medicare and Medicaid – Marlene under an advantage plan (Part C, Humana) and David under Parts A,B, and D (Humana). Marlene should be receiving support from a case manager and coordinated benefits for her extensive needs as a dually eligible individual – but she’s not because the insurer has not met their obligation to follow through. David’s plan requires him to coordinate his own benefits so he relies on his spouse. Both have been denied the services of primary care and comprehensive pain management no matter which Humana administered plan they are on – again due to having been red flagged because of their complex needs and reliance on high dose opiates. This lack of coordinated supports places both of these vulnerable individuals at great risk of error. It also increases the likelihood that because they have neither primary care or pain management physicians in place, they will be wrongfully characterized by ER personnel as drug seeking when they present to their respective hospital emergency facilities in a compromised state of pain.
In our next segment we will take a close look at what happens to both of these individuals with complex care needs when they present to their community providers – the emergency room, and specialists – without the support of primary care coordination or coordinated pain supports appropriate to their individual but complex needs.
You might be interested in these references –
This Federation of State Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain is located at this link-
Model Policy for the Use of Controlled Substances for the Treatment of Pain https://www.ihs.gov/painmanagement/includes/themes/newihstheme/display_objects/documents/modelpolicytreatmentpain.pdf
A number of entities track laws associated with drug control policy and use of controlled substances for pain management legislation at the state level-
Database of Statutes, Regulations, & Other Policies for Pain Management
National Alliance for Model State Drug Laws
Academy of Integrative Pain Management