Financial Viability of the No Surprises Act Independent Dispute Resolution Process: Radiology and Other Hospital-Based Specialties.

BACKGROUND. The federal No Surprises Act (NSA), designed to eliminate surprise medical billing for out-of-network (OON) care for circumstances beyond patients' control, established the independent dispute resolution (IDR) process to settle clinician-payer payment disputes for OON care. OBJECTIVE. The purpose of our study was to assess the fraction of OON claims for which radiologists and other hospital-based specialists can expect to at least break even when challenging payer-determined payments through the NSA IDR process, as a measure of the process's financial viability. METHODS. This retrospective study extracted claims from a national commercial database (Optum's deidentified Clinformatics Data Mart) for hospital-based specialties occurring on the same day as in-network emergency department (ED) visits or inpatient stays from January 2017 to December 2021. OON claims were identified. OON claims batching was simulated using IDR rules. Maximum potential recovered payments from the IDR process were estimated as the difference between the charges and the allowed amount. The percentages of claims for which the maximum potential payment and one-quarter of this amount (a more realistic payment recovery estimate) would exceed IDR fees were determined, using US$150 and US$450 fee thresholds to approximate the range of final 2024 IDR fees. These values represented the percentage of OON claims that would be financially viable candidates for IDR submission. RESULTS. Among 76,221,264 claims for hospital-based specialties associated with in-network ED visits or inpatient stays, 1,482,973 (1.9%) were OON. The maximum potential payment exceeded fee thresholds of US$150 and US$450 for 55.0% and 32.1%, respectively, of batched OON claims for radiologists and 76.8% and 61.3% of batched OON claims for all other hospital-based specialties combined. At payment of one-quarter of that amount, these values were 26.9% and 10.6%, respectively, for radiologists and 56.6% and 38.4% for all other hospital-based specialties combined. CONCLUSION. The IDR process would be financially unviable for a substantial fraction of OON claims for hospital-based specialists (more so for radiology than for other such specialties). CLINICAL IMPACT. Although the NSA enacted important patient protections, IDR fees limit clinicians' opportunities to dispute payer-determined payments and potentially undermine their bargaining power in contract negotiations. Therefore, IDR rulemaking may negatively impact patient access to in-network care.

Brief Assessment of Patient Phenotype to Explain Variability in Postsurgical Pain and Opioid Consumption after Cesarean Delivery: Performance of a Novel Brief Questionnaire Compared to Long Questionnaires.

BACKGROUND: Understanding factors that explain why some women experience greater postoperative pain and consume more opioids after cesarean delivery is crucial to building an evidence base for personalized prevention. Comprehensive psychosocial assessment with validated questionnaires in the preoperative period can be time-consuming. A three-item questionnaire has shown promise as a simpler tool to be integrated into clinical practice, but its brevity may limit the ability to explain heterogeneity in psychosocial pain modulators among individuals. This study compared the explanatory ability of three models: (1) the 3-item questionnaire, (2) a 58-item questionnaire (long) including validated questionnaires (e.g., Brief Pain Inventory, Patient Reported Outcome Measurement Information System [PROMIS]) plus the 3-item questionnaire, and (3) a novel 19-item questionnaire (brief) assessing several psychosocial factors plus the 3-item questionnaire. Additionally, this study explored the utility of adding a pragmatic quantitative sensory test to models. METHODS: In this prospective, observational study, 545 women undergoing cesarean delivery completed questionnaires presurgery. Pain during local anesthetic skin wheal before spinal placement served as a pragmatic quantitative sensory test. Postoperatively, pain and opioid consumption were assessed. Linear regression analysis assessed model fit and the association of model items with pain and opioid consumption during the 48 h after surgery. RESULTS: A modest amount of variability was explained by each of the three models for postoperative pain and opioid consumption. Both the brief and long questionnaire models performed better than the three-item questionnaire but were themselves statistically indistinguishable. Items that were independently associated with pain and opioid consumption included anticipated postsurgical pain medication requirement, surgical anxiety, poor sleep, pre-existing pain, and catastrophic thinking about pain. The quantitative sensory test was itself independently associated with pain across models but only modestly improved models for postoperative pain. CONCLUSIONS: The brief questionnaire may be more clinically feasible than longer validated questionnaires, while still performing better and integrating a more comprehensive psychosocial assessment than the three-item questionnaire.

Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations.

ABSTRACT: Randomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.

A Contemporary Medicolegal Analysis of Outpatient Interventional Pain Procedures: 2009-2016.

BACKGROUND: Closed malpractice claim studies allow a review of rare but often severe complications, yielding useful insight into improving patient safety and decreasing practitioner liability. METHODS: This retrospective observational study of pain medicine malpractice claims utilizes the Controlled Risk Insurance Company Comparative Benchmarking System database, which contains nearly 400,000 malpractice claims drawn from >400 academic and community medical centers. The Controlled Risk Insurance Company Comparative Benchmarking System database was queried for January 1, 2009 through December 31, 2016, for cases with pain medicine as the primary service. Cases involving outpatient interventional pain management were identified. Controlled Risk Insurance Company-coded data fields and the narrative summaries were reviewed by the study authors. RESULTS: A total of 126 closed claims were identified. Forty-one claims resulted in payments to the plaintiffs, with a median payment of $175,000 (range, $2600-$2,950,000). Lumbar interlaminar epidural steroid injections were the most common procedures associated with claims (n = 34), followed by cervical interlaminar epidural steroid injections (n = 31) and trigger point injections (n = 13). The most common alleged injuring events were an improper performance of a procedure (n = 38); alleged nonsterile technique (n = 17); unintentional dural puncture (n = 13); needle misdirected to the spinal cord (n = 11); and needle misdirected to the lung (n = 10). The most common alleged outcomes were worsening pain (n = 26); spinal cord infarct (n = 16); epidural hematoma (n = 9); soft-tissue infection (n = 9); postdural puncture headache (n = 9); and pneumothorax (n = 9). According to the Controlled Risk Insurance Company proprietary contributing factor system, perceived deficits in technical skill were present in 83% of claims. CONCLUSIONS: Epidural steroid injections are among the most commonly performed interventional pain procedures and, while a familiar procedure to pain management practitioners, may result in significant neurological injury. Trigger point injections, while generally considered safe, may result in pneumothorax or injury to other deep structures. Ultimately, the efforts to minimize practitioner liability and patient harm, like the claims themselves, will be multifactorial. Best outcomes will likely come from continued robust training in procedural skills, attention paid to published best practice recommendations, documentation that includes an inclusive consent discussion, and thoughtful patient selection. Limitations for this study are that closed claim data do not cover all complications that occur and skew toward more severe complications. In addition, the data from Controlled Risk Insurance Company Comparative Benchmarking System cannot be independently verified.

A Contemporary Medicolegal Analysis of Outpatient Medication Management in Chronic Pain.

BACKGROUND: Opioids are frequently used in chronic pain management but are associated with significant morbidity and mortality in some patient populations. An important avenue for identifying complications-including serious or rare complications-is the study of closed malpractice claims. The present study is intended to complement the existing closed claims literature by drawing on claims from a more recent timeframe through a partnership with a large malpractice carrier, the Controlled Risk Insurance Company (CRICO). The goal of this study was to identify patient medical comorbidities and aberrant drug behaviors, as well as prescriber practices associated with patient injury and malpractice claims. Another objective was to identify claims most likely to result in payments and use this information to propose a strategy for reducing medicolegal risk. METHODS: The CRICO Strategies Comparative Benchmarking System is a database of claims drawing from >350,000 malpractice claims from Harvard-affiliated institutions and >400 other academic and community institutions across the United States. This database was queried for closed claims from January 1, 2009, to December 31, 2013, and identified 37 cases concerning noninterventional, outpatient chronic pain management. Each file consisted of a narrative summary, including expert witness testimony, as well as coded fields for patient demographics, medical comorbidities, the alleged damaging event, the alleged injurious outcome, the total financial amount incurred, and more. We performed an analysis using these claim files. RESULTS: The mean patient age was 43.5 years, with men representing 59.5% of cases. Payments were made in 27% of cases, with a median payment of $72,500 and a range of $7500-$687,500. The majority of cases related to degenerative joint disease of the spine and failed back surgery syndrome; no patients in this series received treatment of malignant pain. Approximately half (49%) of cases involved a patient death. The use of long-acting opioids and medical conditions affecting the cardiac and pulmonary systems were more closely associated with death than with other outcomes. The nonpain medical conditions present in this analysis included obesity, obstructive sleep apnea, chronic obstructive pulmonary disease, hypertension, and coronary artery disease. Other claims ranged from alleged addiction to opioids from improper prescribing to alleged abandonment with withdrawal of care. The CRICO analysis suggested that patient behavior contributed to over half of these claims, whereas deficits in clinical judgment contributed to approximately 40% of the claims filed. CONCLUSIONS: Claims related to outpatient medication management in pain medicine are multifactorial, stemming from deficits in clinical judgment by physicians, noncooperation in care by patients, and poor clinical documentation. Minimization of both legal risk and patient harm can be achieved by carefully selecting patients for chronic opioid therapy and documenting compliance and improvement with the treatment plan. Medical comorbidities such as obstructive sleep apnea and the use of long-acting opioids may be particularly dangerous. Continuing physician education on the safest and most effective approaches to manage these medications in everyday practice will lead to both improved legal security and patient safety.

A Contemporary Medicolegal Analysis of Implanted Devices for Chronic Pain Management.

BACKGROUND: Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. METHODS: We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service. These cases were identified using the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS), a database containing more than 300,000 malpractice claims from more than 400 academic and community institutions, representing approximately 30% of malpractice cases in the United States. The clinical narratives, which included medical files, claims files, depositions, and expert witness testimony, were reviewed by the authors, as were the CRICO coded variables, which included algorithmically determined contributing factors to the patient injury. RESULTS: Intrathecal drug delivery systems represented 17 of the closed claims; spinal cord stimulators represented 11 of the closed claims. The most common chronic pain diagnoses for which a device was implanted included failed back surgery syndrome and spasticity. The average total incurred for pain medicine claims was $166,028. Damaging events included IDDS refill errors (eg, subcutaneous administration of medication, reprogramming errors), intraoperative nerve damage, and postoperative infection (eg, epidural abscess, meningitis). High-severity outcomes included nerve damage (eg, paraplegia) and death. Medium-severity outcomes included drug reactions (eg, respiratory arrest from opioid overdose) and the need for reoperation. For both IDDS and SCS, deficits in technical skill were the most common contributing factor to injury, followed by deficits in clinical judgment, communication, and documentation. CONCLUSIONS: Implanted devices used for pain management involve a significant risk of morbidity and mortality. Proper education of providers and patients is essential. Providers must acquire the technical skills required for the implantation and refilling of these devices and the clinical skills required for the identification and management of complications such as intrathecal granuloma. Proper patient selection and clear communication between the provider and the patient about these possible complications are of paramount importance.

Injury and Liability Associated with Implantable Devices for Chronic Pain.

BACKGROUND: Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. METHODS: After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. RESULTS: The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). CONCLUSIONS: Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

Trends in Pain Medicine Liability.

BACKGROUND: The authors examined changes in the frequency of pain medicine malpractice claims and associated treatment modalities and outcomes over time. METHODS: The authors analyzed trends in pain medicine claims from 1980 to 2012 in the Anesthesia Closed Claims Project database by binary logistic regression on year of event. Pain procedures in claims from 2000 to 2012 were compared with the proportion of pain procedures reported to the National Anesthesia Clinical Outcomes Registry in 2010-2014. RESULTS: Malpractice claims for pain medicine increased from 3% of 2,966 total malpractice claims in the Anesthesia Closed Claims Project database in 1980-1989 to 18% of 2,743 anesthesia claims in 2000-2012 (odds ratio [OR], 1.088 per year; 95% CI, 1.078 to 1.098; P < 0.001). Outcomes in pain claims became more severe over time, with increases in death and permanent disabling injury (OR, 1.094 per year; P < 0.001). Nonneurolytic cervical injections increased to 27% of pain claims in 2000-2012 (OR, 1.054; P < 0.001), whereas National Anesthesia Clinical Outcomes Registry demonstrates that lumbar injections are a more common procedure. Claims associated with medication management increased to 17% of pain claims in 2000-2012 (OR, 1.116 per year; P < 0.001). CONCLUSIONS: Pain medicine claims have increased over time and have increased in severity. Claims related to cervical procedures were out of proportion to the frequency with which they are performed. These liability findings suggest that pain specialists should aggressively continue the search for safer and more effective therapies.

Chronic pain management in dermatology: a guide to assessment and nonopioid pharmacotherapy.

Pain is a central component of illness and suffering, yet unfortunately it is frequently undertreated. In dermatology, many acute and chronic conditions are characterized by pain that may require therapeutic intervention in addition to medical treatment aimed at treating the primary disease. To date, however, there are limited recommendations or evidence in the published literature on pain and pain management strategies for patients with skin disease. In an effort to enable providers to more comprehensively and effectively treat chronic pain in the primary and multidisciplinary dermatologic context, these topics will be discussed in this 2-part continuing medical education article. Part I of this series will describe important mechanisms of pain and detail individualized chronic pain assessment and treatment strategies using nonopioid analgesia.

Patterns of opioid utilization in pregnancy in a large cohort of commercial insurance beneficiaries in the United States.

BACKGROUND: There are few data regarding the utilization of opioids during pregnancy. The objective of this study was to define the prevalence and patterns of opioid use in a large cohort of pregnant women who were commercial insurance beneficiaries. METHODS: Data for the study were derived from a deidentified research database of women from across the United States who had both medical and prescription benefits. By using diagnostic codes, the authors defined a cohort of 534,500 women with completed pregnancies who were enrolled in a commercial insurance plan from 6 months before pregnancy through delivery. RESULTS: Overall, 76,742 women (14.4%) were dispensed an opioid at some point during pregnancy. There were 30,566 women (5.7%) dispensed an opioid during the first trimester, 30,434 women (5.7%) during the second trimester, and 34,906 women (6.5%) during the third trimester. Of these, 11,747 women (2.2%) were dispensed opioids three or more times during pregnancy. The most commonly dispensed opioids during pregnancy were hydrocodone (6.8%), codeine (6.1%), and oxycodone (2.0%). The prevalence of exposure at anytime during pregnancy decreased slightly during the study period from 14.9% for pregnancies that delivered in 2005 to 12.9% in 2011. The prevalence of exposure varied significantly by region and was lowest in the Northeast and highest in the South. CONCLUSIONS: This study demonstrates that opioids are very common exposures during pregnancy. Given the small and inconsistent body of literature on their safety in pregnancy, these findings suggest a need for research in this area.

Epidural steroids: a comprehensive, evidence-based review.

Epidural steroid injections (ESIs) are the most widely utilized pain management procedure in the world, their use supported by more than 45 placebo-controlled studies and dozens of systematic reviews. Despite the extensive literature on the subject, there continues to be considerable controversy surrounding their safety and efficacy. The results of clinical trials and review articles are heavily influenced by specialty, with those done by interventional pain physicians more likely to yield positive findings. Overall, more than half of controlled studies have demonstrated positive findings, suggesting a modest effect size lasting less than 3 months in well-selected individuals. Transforaminal injections are more likely to yield positive results than interlaminar or caudal injections, and subgroup analyses indicate a slightly greater likelihood for a positive response for lumbar herniated disk, compared with spinal stenosis or axial spinal pain. Other factors that may increase the likelihood of a positive outcome in clinical trials include the use of a nonepidural (eg, intramuscular) control group, higher volumes in the treatment group, and the use of depo-steroid. Serious complications are rare following ESIs, provided proper precautions are taken. Although there are no clinical trials comparing different numbers of injections, guidelines suggest that the number of injections should be tailored to individual response, rather than a set series. Most subgroup analyses of controlled studies show no difference in surgical rates between ESI and control patients; however, randomized studies conducted by spine surgeons, in surgically amenable patients with standardized operative criteria, indicate that in some patients the strategic use of ESI may prevent surgery.

Injury and liability associated with cervical procedures for chronic pain.

BACKGROUND: Prompted by an increase in interventional pain treatments performed at the level of the cervical spine, we investigated the characteristics and patterns of injury in malpractice claims collected from January 1, 2005 to December 31, 2008. METHODS: We compared claims arising from cervical pain treatments with all other chronic pain claims collected from the American Society of Anesthesiologists' closed claims database between 2005 and 2008. Claims for spinal cord injury underwent in-depth analysis for mechanisms of injury and use of sedation during the procedure. RESULTS: Claims related to cervical interventions represented 22% (64/294) of chronic pain treatment claims. Patients who underwent cervical procedures were healthier (American Society of Anesthesiologists' score, 1-2; P < 0.001) and were more often women (P = 0.011). Of the patients who underwent a cervical procedure, 59% experienced spinal cord damage compared with 11% of patients with other chronic pain (P < 0.001), with direct needle trauma as the predominant cause (31%). General anesthesia or sedation was used in 67% of cervical procedure claims associated with spinal cord injuries but in only 19% of cervical procedure claims not associated with spinal cord injuries (P < 0.001). Of the patients who underwent cervical procedures and had spinal cord injuries, 25% were nonresponsive during the procedure compared with 5% of the patients who underwent cervical procedures and did not have spinal cord injuries (P < 0.05, κ = 0.52). CONCLUSIONS: Injuries related to cervical interventional pain treatment were often severe and related to direct needle trauma to the spinal cord. Traumatic spinal cord injury was more common in patients who received sedation or general anesthesia and in those who were unresponsive during the procedure. Further studies are crucial to define the usefulness of cervical interventions and to improve their safety.

Malpractice claims associated with medication management for chronic pain.

BACKGROUND: Medication management is an integral part of chronic pain management. Prompted by an increase in the role of medication management in anesthesia chronic pain liability, we investigated the characteristics of malpractice claims collected from 2005 to 2008. METHODS: After Institutional Review Board approval, we compared medication management claims with other chronic pain claims from the American Society of Anesthesiologists Closed Claims Database of 8,954 claims. Claims for death underwent in-depth analysis. RESULTS: Medication management represented 17% of 295 chronic non-cancer pain claims. Compared with other chronic pain claims, medication management patients tended to be younger men (P < 0.01) with back pain. Most patients were prescribed opioids (94%) and also additional psychoactive medications (58%). Eighty percent of patients had at least one factor commonly associated with medication misuse and 24% had >or= 3 factors. Most claims (82%) involved patients who did not cooperate in their care (69%) or inappropriate medication management by physicians (59%). Death was the most common outcome in medication management claims (57% vs. 9% in other chronic pain claims, P < 0.01). Factors associated with death included long-acting opioids, additional psychoactive medications, and >or= 3 factors commonly associated with medication misuse. Alleged addiction from prescribed opioids was the complaint in 24%. Appropriateness of care and payments was similar for medication management versus other chronic pain claims. CONCLUSIONS: Most anesthesia malpractice claims for medication management problems involved patients with a history of risk behaviors commonly associated with medication misuse. Malpractice claims arising from medication management had a high proportion of deaths with both patient and physician contributions to the outcome.

Assessment, physiological monitoring, and consequences of inadequately treated acute pain.

Postoperative pain is a major health care issue. Several factors have contributed to inadequate postoperative pain control, including a lack of understanding of preemptive pain management strategies, mistaken beliefs and expectations of patients, inconsistencies in pain assessment practices, use of as-needed analgesics that patients must request, and lack of analgesic regimens that account for interindividual differences and requirements. Untreated acute pain has the potential to produce acute neurohumoral changes, neuronal remodeling, and long-lasting psychologic and emotional distress and may lead to prolonged chronic pain states. To effectively manage postoperative pain, nurses must be able to adequately assess pain severity in diverse patient populations, understand how to monitor physiologic changes associated with pain and its treatment, be prepared to address the psychosocial experiences accompanying pain, and know the consequences of inadequate analgesia. It is important for nurses to be aware of relevant research and evidence-based guidelines that are available to guide pain assessments and patient monitoring practices.