To Enable or Make Stable?: The Emtala Dilemma in the Opioid Crisis
Celebrity drug overdose stories have sent shock waves through Hollywood for years…Hank Williams, Elvis Presley, Prince…many of the greats gone before their time, forever enshrined upon the pedestals upon which America placed them. Historically pushed from the limelight are the demons with which they wrestled and which ultimately lead to their untimely deaths. Less heralded but equally devastating deaths attributable to drug overdoses have also skyrocketed in the U.S., those demons are now taking center stage. Namely, opioid addiction.
As noted throughout this issue of AANS Neurosurgeon, the history of pain, opioid use and abuse has many facets. Opioids, derived from the poppy plant, include both prescription and illegal derivatives, including oxycodone, hydrocodone, codeine, morphine, fentanyl and heroin (1). Prescription opioids are indicated for pain management. In fact, 20 percent of patients in an office-based setting reporting non-cancer pain or pain-related diagnoses are prescribed an opioid (2).
Opioids By the Numbers
The Centers for Disease Control and Prevention (CDC) reports that 6 in 10 drug overdose deaths involve an opioid and the number of those deaths involving an opioid has quadrupled since 1999. Also quadrupling since 1999 is the number of prescription opioids sold. Surprisingly, what does not appear to have increased in the same period of time is the amount of pain reported (3). A handful of states are experiencing the effect more than others. Recent studies have shown West Virginia has the highest rate of overdose deaths per capita, with New Hampshire, Kentucky, Ohio and Rhode Island also experiencing staggering numbers (4).
A dramatic rise in heroin addiction within a new demographic (e.g. older, white populations living in non-urban areas (5)) has led many to focus on the relationship between heroin, an illegal opioid, and its legal cousins, prescription painkillers. The results of such inquiries have revealed a common trend – abuse of prescription drugs often devolves into heroin addictions – implicating a variety of factors including increased tolerance levels, availability and cost (6). As the connection to prescription drug abuse continues as a central focus to combating the epidemic, regulators and lawmakers are naturally looking at the source of those prescriptions: drug manufacturers and prescribing physicians.
Combating the Epidemic
By some estimates, the prescription opioid market is a $13 billion a year industry (7). As states and local governments struggle to find the resources to deal with this public health crisis, many are looking to the manufacturers to contribute to the cause – willingly or unwillingly. On Aug. 15, 2017, South Carolina joined more than 20 other states (7), cities and counties filing suit against opioid drug manufacturers when it sued Purdue Pharma LP, the manufacturer of OxyContin (8). While each lawsuit is different, the general theme is that manufacturers marketed these drugs as safe, non-addictive and overstated the benefits of opioids compared to other pain management therapies, so as a result, physicians have been overprescribing them for years (7).
While states are looking to the deep pockets of pharma for the resources to combat the epidemic, the physician prescribers are not without scrutiny. The Drug Enforcement Agency (DEA) has stepped up enforcement action against overprescribing physicians, accepting surrender of 3,679 prescribing licenses and revoking 99 between 2011 and 2015 (9). Similarly, the Department of Justice (DOJ) is responding to the “national emergency” (10) by prosecuting providers for defrauding Medicare by submitting claims for unnecessary opioid subscriptions (11). States are also pursuing strategies to combat the epidemic (12) and targeting prescribers (13).
Despite efforts by federal, state and local regulators to reduce the number of prescription opioids available on the market, both legally and illegally, other areas of health care regulation seem to continue to enforce the historical inclination to treat pain with prescription opioids. Most notably, the Emergency Medical Treatment and Active Labor Act (EMTALA), and the related guidance from the Centers for Medicare & Medicaid Services (CMS), pose a unique dichotomy for physicians and the facilities at which they work – hospitals.
EMTALA (passed in 1996 to insure appropriate emergency care for all), sets forth requirements for all hospitals participating in the Medicare program (14). Following modifications over time, EMTALA now requires all hospitals with emergency departments to provide to every individual presenting thereto a medical screening examination, the purpose being to determine whether an emergency medical condition exists and to stabilize that condition (15).
As it relates to the opioid crisis, severe pain is specifically named in the statute and symptoms of substance abuse are included as an “emergency medical condition” in the regulations (16). Accordingly, such conditions may require stabilization (17). While EMTALA does not specifically prescribe the method in which a provider must stabilize an emergency medical condition, interpretive guidance from CMS does suggest a provider may have an EMTALA obligation to provide a patient with prescription drugs where such medication may, in fact, stabilize the patient’s emergency medical condition (18).
Facilities failing to comply with EMTALA face significant civil penalties of $50,000 per violation (19), and CMS could terminate their Medicare participation agreements (20). Perhaps more daunting, though, is the private right of action to sue for damages that EMTALA created for individuals harmed by a hospital’s violation (21). Physicians, individually, may similarly be fined up to $50,000 per violation (22), or terminated from the Medicare program (23), but, notably, the private right of action does not extend to physicians (24).
Position of CMS
In light of the obligation to stabilize and the stiff penalties facing hospitals and physicians, historical practice has been to stabilize such patients with at least a dose or short-term prescription for the painkillers they seek. However, states are recognizing the incentive this practice creates for those struggling with addiction to present to the emergency room for what practically amounts to a guaranteed “fix.” Accordingly, a few states have “developed and displayed posters in their emergency departments to ‘educate’ patients regarding the [emergency department’s] restrictions concerning opioid administration in the [emergency department] or in providing pain prescriptions via the emergency physicians.”(25) Further, the New York City Department of Health and Mental Hygiene officially adopted guidelines with recommendations on prescribing opioid analgesics to patients being discharged from the emergency department (26).
Such efforts have been supported by local and national professional societies, including the American College of Emergency Physicians (ACEP), Ohio Hospital Association and the South Carolina Hospital Association. Unfortunately, CMS has not embraced this practice so enthusiastically. The South Carolina Hospital Association submitted a copy of its intended signage to the Atlanta Regional Office of CMS for approval, and CMS responded by citing concerns that such signage may implicate noncompliance with EMTALA. Specifically, CMS was concerned that the sign “might be considered to be coercive or intimidating to patients who present to the [emergency department] with painful medical conditions, thereby violating both the language and the intent of the EMTALA statute and regulations.” Citing the greater good and protecting patients with legitimate medical needs, including pain management needs, CMS emphasized that professional judgment should be exercised on an individual basis within the context of the medical screening, rather than blanket statements posted in the entire emergency room.(25)
Following this opinion by the Atlanta Regional Office, the Ohio Hospital Association contacted the Chicago Regional Office of CMS regarding the Emergency and Acute Care Facility Opioid and Other Controlled Substances Prescribing Guidelines finalized and adopted by the Governor’s Cabinet Opiate Action Team Professional Education Working Group in April 2012 (27). Unfortunately, the Chicago Regional Office reached the same conclusion, and Ohio hospitals were advised to remove the guidelines from their emergency departments.
Given the tremendous risk a violation of EMTALA carries, this position taken by CMS appears to have doomed, or at least significantly quelled, local efforts to combat the opioid crisis in the emergency room. While patient education and professional judgment are integral to any successful strategy, physicians prescribing habits are also under immense scrutiny – placing at risk medical licensure and prescribing authority. Thus, until federal and state regulators align priorities or other solutions are developed, the ethical dilemma continues across America’s emergency rooms – to enable or make stable?
14. 42 U.S.C.A. § 1395dd; 42 C.F.R. pts. 405, 489, 1001, 1003.
15. 42 U.S.C.A. § 1395dd(a).
16. 42 C.F.R. § 489.24(b).
17. 42 U.S.C.A. § 1395dd(e)(3)(A); 42 C.F.R. § 489.24(b).
18. State Operations Manual. Tag A-2406/C-2406, Interpretive Guidelines § 489.24(c).
19. 42 U.S.C.A. § 1395dd(d)(1)(A). Hospitals with fewer than 100 beds may be fined up to $25,000. 42 U.S.C.A. §1395dd(d)(1)(A).
20. 42 C.F.R. § 489.24(g); 42 C.F.R. § 489.53(b); see also 42 C.F.R. § 1003.500(c) (regarding exclusion from all federal health care programs for “gross and flagrant” or repeated violations).
21. 42 U.S.C.A. § 1395dd(d)(2)(A), (B).
22. 42 U.S.C.A. § 1395dd(d)(1)(B).
23. 42 C.F.R. § 1003.500.
24. Emerus Hosp. v. Health Care Serv. Corp., No. 13-C-8906, 2016 WL 946916, at *4 (N.D. Ill. Mar. 14, 2016) (“[P]rivate causes of action under EMTALA are limited to suits against hospitals.”); Kaufman v. Cserny, 856 F. Supp. 1307, 1310 (S.D. Ill. 1994).
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