Pain, Legislators, and EMTALA
By Kevin Klauer, DO, EJD, Chief Medical Officer, Emergency Medicine Physicians, Canton, OH
As the health care environment continues to evolve, new threats emerge, and 2014 seems to have some very unique challenges. This article will highlight three important risk management topics for 2014. If these three are addressed by risk managers and individual providers, future claims from this calendar year may be avoided.
The prescription drug abuse epidemic in this country is a serious problem with implications not only for at-risk patients, but for providers. Providers must be mindful to identify patients at risk for abuse/overdose. However, the pendulum must not swing too far, resulting in reduced access to care for those with chronic medical conditions and compliance problems with the Emergency Medical Treatment and Active Labor Act (EMTALA). Legislative/regulatory efforts have been adopted to address this epidemic. However, such initiatives may be misguided. For instance, the New York City recommendations are well-intentioned, attempting to provide guidance (i.e., "Provide information about opioid analgesics to patients receiving a prescription, such as the risks of overdose and dependence/ addiction, as well as safe storage and proper disposal of unused medications"). However, when the practice of medicine is legislated, even with physician input, as with the New York guidelines, the law of unintended consequences comes into play. This becomes problematic when the guidance deals with clinical decision making (i.e., "Prescribe no more than a short course of opioid analgesics for acute pain. Most patients require no more than three days").
When such guidance is not strictly followed, it may provide ammunition for plaintiff's attorneys to allege negligence. It is also important to note that emergency medicine has been expected to accept responsibility for a public health problem that it did not create. Nonetheless, legislative efforts seem to focus on emergency medicine, not more significant sources of opioid prescribing. "Because most opioids are prescribed by primary care physicians, the introduction of these guidelines alone is unlikely to effect a large decrease in opioid-related harm."1
Providers in jurisdictions where such initiatives exist should be mindful of the guidelines; deviations from them should be well documented, including the rationale for doing so. To reduce the risk for unsafely discharging patients who received opioids, recognizing the potency of parenteral opioids (morphine equivalent dosing) is essential to safe prescribing (i.e., fentanyl 100:1; hydromorphone 5-7:1). Observation following parenteral opioids and the patient's safe discharge status should be documented.
On January 18, 2013, the South Carolina Hospital Association submitted a request to the Centers for Medicare & Medicaid Services (CMS). The opinion was sought for clarification about EMTALA and their proposed plan to post signs in their ED waiting rooms and treatment areas about the use of opioids.
The following is an excerpt from the South Carolina plan:
Our emergency department staff understands that pain relief is important when one is hurt or needs emergency care.
The primary role of the emergency medicine provider is to look for and treat an emergency medical condition.
You may be asked about a history of pain medication use, misuse, or substance abuse before prescribing any pain medication.
We may ask you to show a photo ID, such as a driver's license, when you check into the emergency department or receive a prescription for pain medications. We may also research the statewide prescription database regarding your prescription drug use.
We may only provide enough pain medication to last until you can contact your doctor. We will prescribe pain medications with a lower risk of addiction and/or overdose when possible.
For your safety, we do not:
Give pain medication shots for sudden increases in chronic pain, or aggravation of chronic pain syndromes.
Refill lost or stolen prescriptions for medications. You must obtain refill prescriptions from your primary care provider or pain clinician.
Prescribe missed methadone doses, or provide prescription refills for chronic pain management.
Prescribe long-acting pain medications, such as OxyContin, MSContin, fentanyl patches, or methadone for chronic, non-cancer pain.
Prescribe pain medications if you already receive pain medication from another doctor or emergency department.
Whether or not providers agree with these limitations is immaterial with respect to EMTALA. CMS Region IV responded by stating that 42 CFR 489.24 B notes that an emergency medical condition includes "severe pain, psychiatric disturbances and/or symptoms of substance abuse." Furthermore, posting such signs "might be considered coercive or intimidating to patients who present to the ED with painful medical conditions, thereby violating both the language and intent of the EMTALA statute and regulations."
Some have said that the opinion is only a recommendation and only impacts Region IV. This simply is not the case. According to Richard Wild, "this letter was developed in consultation with CMS' central office, has been shared with all CMS regional offices, and is being followed by CMS regional offices. However, given the frequency with which the issue is now arising and the questions about whether this letter represents CMS policy, CMS may issue a national memorandum on the topic."2
Other states (e.g., Washington) have taken a gentler approach with the content of their posters. Nonetheless, the fact remains that no other subset of ED patients is addressed in this manner before receiving their EMTALA-mandated medical screening examination. Therefore, even well-intentioned initiatives may result in dissuading patients from seeking medical care and, thus, may result in compliance issues with EMTALA.
Recommendations: Perform the medical screening examination, then care for the patient, instituting whatever treatment plan considered to be appropriate for the patient in light of the potential for opiod prescription abuse and overdose. You just can't decide this in advance of the evaluation.
According to Richard E. Wild, "In accordance with standard accepted medical practices and in accordance with the provisions of EMTALA, every individual who presents to the emergency department for any medical condition or complaint should first receive an appropriate medical screening exam by a properly trained and credentialed qualified medical professional. This exam is not a triage exam, but is explicitly tailored to address the particular signs and symptoms of the patient. An appropriate medical screening exam uses all the available resources of the emergency department, which are appropriate to determine whether an emergency medical condition exists. After an appropriate medical screening exam is conducted, it is within the bounds of professional medical judgment and discretion for an appropriately licensed physician or other health care practitioner to provide or to withhold narcotic or other methods of pain control in a particular patient depending on the specific clinical circumstances. It is also left to the judgment of the provider as to how best to give specific patient-centered education, including handouts, policies, and institutional protocols. But again, it is emphasized that patient education should take place after a patient-focused medical screening exam is completed and not by posting general policies and procedures or displaying such materials in the waiting area."3
Sepsis and Risk
The white-hot light of the media has illuminated sepsis to the general public and plaintiff's attorneys. Early goal-directed therapy (EGDT) is recognized as a (not "the") standard, and an easy basis for a standard-of-care allegation. Despite the fact that sepsis is often a retrospective diagnosis, this defense strategy is not easy to prove to a jury. Sepsis lawsuits have significantly increased in the past few years. Although EGDT prompted earlier recognition and management, this same attention has an ugly downside: alleged negligence. One of the greatest burdens in sepsis cases is they often convert a young, healthy person into a very sympathetic plaintiff. Sepsis rarely has a happy ending; many lives are saved, many are lost, and those that are saved often suffer substantial complications and morbidity. Plaintiffs have been very successful proving that the complications from sepsis may be worse than death. When medical economists weigh in, the estimates for the care required for survivors are truly staggering. Such estimates frequently result in judgments and settlements in excess of similar cases that resulted in death. Although it seems harsh, it is frequently more expensive to harm a patient than to cause the death of one. When considering "damages," there is a method to this madness. Basically, damages are derived from three categories: special, general, and punitive. Punitive damages in medical malpractice cases are very, very unusual. The purpose is to deter the defendant and others from engaging in similar egregious activity. Thus, punitive damages can reach astronomical numbers. Special damages, also known as economic damages, are those relating to lost earnings, medical expenses (past and ongoing), etc. General damages, or non-economic damages, compensate a plaintiff for pain and suffering, mental anguish, loss of companionship, loss of consortium (deprivation of family relationships), loss of enjoyment of life, disfigurement, etc.
As more sepsis patients survive, more cases are filed due to complications and their treatment. In particular, limb amputations are over-represented in cases of sepsis, alleging misdiagnosis or delayed diagnosis. Plaintiffs allege that the management, or delay thereof, result in limb ischemia and amputations. However, limb amputations are a known complication of sepsis, and as more patients survive, more will lose limbs.
Purpura fulminans is one cause of limb amputations in sepsis.4 This is an uncommon entity. However, when you select a pool of patients with bad outcomes from sepsis, it doesn't seem so rare anymore. Purpura fulminans results in small vessel microthrombi and occasionally vasculitis. It primarily affects children and infants, but also affects adults.5 Another contributing factor to limb amputation in sepsis is the use of vasopressors.6 Although vasopressors may be of clinical value following adequate volume resuscitation, these medications are far from benign. If vasopressors are used prior to adequate volume resuscitation, end-organ ischemia may result due to the vasoconstriction from the alpha effect from the vasopressor, despite the fact that mean arterial pressure may improve. Even with adequate resuscitation, this vasoconstriction may cause tissue or limb ischemia.
On August 18, 2003, David Fitzgerald presented to RHD Memorial Medical Center in Dallas, Texas. He complained of abdominal pain and was ultimately diagnosed with a duodenal ulcer, requiring surgery. The surgical procedure was performed on August 29, 2003; however, on September 1, Fitzgerald developed septic shock. He was treated with antimicrobials, fluids, etc. He was also treated with vasopressors for his persistent hypotension. He subsequently developed gangrene in all four extremities, ultimately requiring bilateral below-knee amputations (BKAs) and bilateral arm amputations below the elbow. The patient was diagnosed with hospital-acquired methicillin-resistant Staphylococcus aureus (MRSA) pneumonia on September 7, 2003.
A lawsuit was filed. The primary allegation was a delay in initiating vancomycin. As a defense strategy, the experts contended that the delay in treatment didn't result in limb amputation. Although necessary for the treatment of hypotension, the vasopressors, not the failure to treat the infection, resulted in the "limb loss." This strategy failed to impress the jury. They awarded the following judgment: "$5 million for past and future physical pain and mental anguish; $144,350 for loss of earning capacity in the past; $300,300 for loss of earning capacity in the future; $3 million for past and future disfigurement; $3 million for past and future physical impairment; $1.28 million for medical expenses paid or incurred; and $5 million for future medical expenses." The court modified the settlement to a sum of $5,240,182.16.7 This case illustrates how damages resulting from sepsis can accumulate beyond comprehension.
The take-home message is to consider the diagnosis of sepsis early and treat accordingly. However, to mitigate risk, the wise provider will discuss the potential complications that may result from sepsis, particularly those in septic shock, with the patient and family. In addition, when using pressors in sepsis, it is wise to discuss that despite their necessity, the decision will likely come with a price. Obtaining informed consent is also a very reasonable consideration, as a "reasonable patient" cannot be expected to understand the risks and benefits without an informed discussion. In severe sepsis, the decision may actually be life or limb. The patient may not be lucky enough to keep both.
Non-physician Provider Scope of Practice
The use of physician assistants and advanced practice nurses in emergency medicine is a welcome and necessary addition to augment the weakened workforce in the American health care system's safety net, the emergency department. Collaboration between non-physician clinicians (NPC) and physicians has been shown to improve efficiency and reduce expense, while addressing current workforce issues in emergency medicine (EM). However, as this trend has gained momentum in the past several years, EM staffing models incorporating these providers has become not only widely accepted, but also recognized as a critical piece of the staffing equation. Unfortunately, rapid adoption of this concept has exceeded the ability to plan, provide structure, and safely operationalize these staffing models. This has left some stones unturned with respect to NPCs, and those stones have medical legal implications.
The primary issues are scope of practice (SOP), credentialing, and supervision. With respect to SOP, regulators frequently allow the supervising physician to determine the SOP for physician assistants. For example, according to the Wyoming Board of Medicine regulations, "The board does not recognize or bestow any level of competency upon a physician assistant to carry out a specific task. Such recognition of skill is the responsibility of the supervising physician. However, a physician assistant is expected to perform with similar skill and competency and to be evaluated by the same standards as the physician in the performance of assigned duties."8 Advanced practice nurses have the ability to practice without a collaborative agreement in most states. However, in emergency medicine, this is rarely the case, as most NPCs in the emergency department work with some degree of supervision by a physician, and physician assistants and nurse practitioners are frequently used in an equal capacity in that setting. A review of many state nursing practice acts and nursing board regulations reveals a lack clarity with respect to scope of practice (i.e., central venous line placement, airway management, chest tube thoracostomy, etc.).
Thus, SOP is often defined by the supervising physician and the hospital credentialing processes and procedures. Again, there appears to be a breakdown in the system at this point. Many hospital credentialing processes do not clearly delineate the SOP of NPCs or the necessary training, proficiency, or verification required to perform specific procedures. For example, a physician assistant with 20 years of cardiothoracic experience placing multiple chest tubes a day is certainly qualified to place them in the emergency department. However, a newly graduated PA probably is not without additional training and demonstrated proficiency. Unfortunately, many times no clear distinction is made between the scopes of practice for such providers while working in an emergency department.
The Joint Commission is clear on this issue. If NPCs will provide "medical level of care," they must be privileged and credentialed through the medical staff processes in place.
The following is the official Joint Commission statement:
"Those who provide 'medical level of care' must use the medical staff process for credentialing and privileging, making all [medical staff] standards applicable (including recommendation by the organized medical staff and approval by the governing body, OPPE, and FPPE).
- APNs should request privileges only for those responsibilities involving medical level of care and not those responsibilities already allowed under the RN scope of practice.
- APNs and PAs who provide 'medical level of care' must be credentialed and privileged through the medical staff standards process.
- APNs and PAs who do not provide 'medical level of care' utilize the human resources 'equivalent' process detailed in HR.01.02.05, EPs 1015."
The level of supervision provided is a critical issue. There are several options: autonomous, indirect supervision (consultation or no consultation), and direct supervision. Physician assistants are dependent practitioners and must have a supervisory agreement. True autonomous practice, or no supervision, is only available to nurse practitioners in states where collaborative agreements are not required. In most emergency departments, except for underserved areas, physicians are immediately available and provide a higher level of supervision. Indirect supervision comes in the form of consultation (discussing the case with the physician without independent evaluation by the physician) and no consultation (reviewing charts for appropriateness of care and signing them). Finally, direct supervision requires an independent evaluation by the physician.9 This is the only means by which the visit can be billed at 100% of the physician fee schedule. Without "face to face" time and direct supervision, the chart may only be billed at 85% of the physician fee schedule for Medicare, Medicaid, and most other third party payers.
Most agree that the level of supervision may vary, depending on the complexity or acuity of the case. However, these standards should be stipulated in policy and strictly adhered to. In some settings, NPCs may see low acuity visits (i.e., ESI triage categories 4 and 5) without direct supervision, while higher acuity cases are either directly supervised (i.e., ESI category 3) or seen primarily by the physician with assistance from the NPC (ESI categories 1 and 2). However, it is critical to mitigate risk by structuring the most appropriate supervisory program and adhering to the policy.
Although not always practical, direct supervision reduces risk by involving two clinicians, two sets of eyes. Theoretically, the quality of care should benefit from this. However, in cases in which direct supervision is deemed unnecessary, indirect supervision is acceptable. It is important to recognize that just because the physician did not see the patient independently, he or she still has liability exposure as the supervising physician. Fortunately, in many lawsuits dealing with indirect supervision, the physician is ultimately dismissed from the lawsuit, particularly when policy governing NPC supervision was followed.
In summary, to safely incorporate NPCs into the workforce, the SOP (procedures and types of patients to be seen) must be defined, training should be provided with verification of procedural competency, appropriate credentialing should be performed, and supervisory requirements clearly defined in policy, and the policy should be appropriately executed and enforced.
REFERENCES
- The New York City Recommendations. JAMA. 2013;309:879.
- Interview: Richard E. Wild, MD; Atlanta Regional Office Centers for Medicare and Medicaid Services (CMS); ACEP Now, January 2014.
- Interview: Supra; ACEP Now, January 2014
- Davis MDP, Dy KM, Nelson S. Presentation and outcome of purpura fulminans associated with peripheral gangrene in 12 patients at Mayo Clinic. J Am Acad Dermatol. 2013;57:944-956.
- Alvarez EF, Olarte KE, Ramesh MS. Purpura fulminans secondary to Streptococcus pneumoniae meningitis. Case Rep Infect Dis. 2012;2012:503-508.
- Cho AR, Kim JI, Kim EJ, Son SM. Skin necrosis after high dose vasopressor infusion in septic shock — two case reports. Korean J Crit Care Med. 2012;3:182-186.
- Prabhakar v. Fitzgerald, Tex: Court of Appeals, 5th Dist. 2012
- Wyoming Board of Medicine Rules and Regulations (2007). Chapter 5, Section 4d.
- Klauer K. Innovative staffing in emergency departments: The role of midlevel providers. CJEM. 2013;15:134-140.
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