Impact of Anti-Discrimination Legislation on Access to Gender-affirming Care: A Commercial Claims Analysis.

OBJECTIVE: To examine the temporal relationship between the anti-discrimination rules of the Affordable Care Act, which took full effect in 2017, and the incidence of commercial claims for gender-affirming care, as well as cost sharing for these services. METHODS: We used a previously described algorithm to define a cohort of gender-diverse adults in the MarketScan Commercial Claims and Encounters Database. Claims for gender-affirming medical and surgical care were identified using International Classification of Diseases and Current Procedural Terminology codes plus pharmacy data; the annual incidence of surgical claims was calculated. Interrupted time series analyses were used to evaluate the temporal relationship between claims and anti-discrimination legislation. Claims data were also used to evaluate the patient contribution towards services. RESULTS: There were 70,733 gender-diverse adults included in the study and 36,702 (51.9%) of them filed claims for gender-affirming care. The incidence of persons with claims for gender-affirming surgery increased from 0.002% in 2009 to 0.012% in 2021. Interrupted time series analyses demonstrated a greater year-to-year increase in claims after anti-discrimination policy influences took effect. This change was greatest for transmasculine chest procedures. The median lifetime net payment for gender-affirming surgery was $12,429.10 and cost sharing was $1019.20 (8.6%). CONCLUSION: Commercial claims for gender-affirming surgery increased temporally with respect to implementation of anti-discrimination legislation and cost-sharing was reasonably low. However, many gender-diverse persons did not have claims for gender-affirming care, which may indicate continued out-of-pocket payment for these services.

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims. Final rule.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.

Off-label prescriptions and decisions on reimbursement requests in Germany - a retrospective analysis.

BACKGROUND AND OBJECTIVES: "Off-label use" is defined as the prescription of pharmaceutical products outside their approved indications. Rare diseases frequently lack "on-label" treatment options. In order to avoid reimbursement claims following the prescription of off-label drugs, physicians in Germany can - on a case-by-case basis - file an application for cost coverage with the competent health insurance prior to treatment initiation. PATIENTS AND METHODS: We conducted a chart review for cost coverage requests submitted by two outpatient clinics at a university-affiliated dermatology department between 2010 and 2012 (clinic for autoimmune diseases and urticaria clinic). Insurance providers, acceptance rates, reasons for rejection, and processing times were analyzed. RESULTS: The analysis showed that 56.8 % of applications for off-label use (n = 44) were approved during the first round. The rate increased to 75.0 % when including approvals granted after up to two rejections. The time between initial application and the response of health insurers was 49 days (median). In case of cost coverage approval, treatments were initiated 92 days (median) after the initial request. CONCLUSIONS: The present case series shows that, in the majority of cases, health insurers in Germany have agreed to reimburse the costs of proposed off-label therapies. A prospective study is required in order to evaluate whether current changes to legal regulations (GKV-Versorgungsstrukturgesetz, Patientenrechtegesetz) adequately address the problems identified.

NHSLA litigation in hip fractures: Lessons learnt from NHSLA data.

Hip fractures are a major cause of trauma related death, usually occurring in vulnerable elderly patients. There are an estimated 70,000 hip fractures in the UK per year with numbers set to rise. The estimated annual cost to the healthcare economy is in the region of £2 billion. A 17-year review examining litigation related to hip fractures was undertaken. Under a freedom of information request, data was obtained relating to all orthopaedic claims made to the NHS Litigation Authority (NHSLA) between 1995 and 2012. Data was filtered to identify cases involving hip fractures examining litigation trends related to this specific area. 10263 NHSLA orthopaedic cases were identified, of which 13.3% (n=1364) cases related to the hip and femur. Hip fractures made up 16.7% (n=229). The total cost of hip fracture litigation was over £7 million with an average cost per case of £32,700. The commonest reasons for litigation were diagnostic errors (30.6%), issues with care (24.9%) alleged incompetent surgery (15.7%) and development of pressure sores (5.7%). This study highlights the main causes of litigation in patients sustaining hip fractures, with diagnosis in the emergency department and ward presenting a significant problem. In addition, the data identifies a range of care related issues, as well as several surgical factors and highlights the importance of pressure area care. We discuss these and make suggestions on how to improve practice in this area with the aim of improving patient care and reducing litigation.

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.

Risk factors for injuries associated with damage claims following groin hernia repair.

PURPOSE: Surgical repair of groin hernia should be carried out with minimal complication rates, and it is important to have regular quality control and accurate means of assessment. The Swedish healthcare system has a mutual insurance company (LÖF) that receives claims from patients who have suffered healthcare-related damage or malpractice. The Swedish Hernia Register (SHR) currently covers around 98% of all Swedish groin hernia operations. The aim of this study was to analyse damage claims following groin hernia repair surgery and link these with entries in the SHR, in order to identify risk factors and causes of injuries and malpractice associated with hernia repair. METHODS: Data on all 48,574 groin hernia operations registered in the SHR between 2008 and 2010 were compared and linked with data on claims made to the Swedish National Patient Injury Insurance (LÖF). RESULTS: Of the 130 damage claims received by LÖF, 26 dealt with bleeding, 20 with testicular injury and 7 with intestinal lesions. Eighty (62%) of the complications were considered malpractice according to the Swedish Patient Injury Act. Acute and recurrent surgery, sutured repair and general anaesthesia were associated with a significantly increased risk for a damage claim independently the patients were compensated or not. Females filed claims in greater proportion than males. There was no significant difference in background factors between claims accepted by LÖF and compensated and those who were rejected compensation. CONCLUSION: Risk factors for filing a damage claim included acute surgery, operation for recurrence, sutured repair and general anaesthesia, whereas local anaesthesia reduced the risk.

Neonatal hypoglycaemia: learning from claims.

OBJECTIVES: Neonatal hypoglycaemia is a potential cause of neonatal morbidity, and on rare but tragic occasions causes long-term neurodevelopmental harm with consequent emotional and practical costs for the family. The organisational cost to the NHS includes the cost of successful litigation claims. The purpose of the review was to identify themes that could alert clinicians to common pitfalls and thus improve patient safety. DESIGN: The NHS Litigation Authority (NHS LA) Claims Management System was reviewed to identify and review 30 claims for injury secondary to neonatal hypoglycaemia, which were notified to the NHS LA between 2002 and 2011. SETTING: NHS LA. PATIENTS: Anonymised documentation relating to 30 neonates for whom claims were made relating to neonatal hypoglycaemia. Dates of birth were between 1995 and 2010. INTERVENTIONS: Review of documentation held on the NHS LA database. MAIN OUTCOME MEASURES: Identifiable risk factors for hypoglycaemia, presenting clinical signs, possible deficits in care, financial costs of litigation. RESULTS: All claims related to babies of at least 36 weeks' gestation. The most common risk factor for hypoglycaemia was low birth weight or borderline low birth weight, and the most common reported presenting sign was abnormal feeding behaviour. A number of likely deficits in care were reported, all of which were avoidable. In this 10-year reporting period, there were 25 claims for which damages were paid, with a total financial cost of claims to the NHS of £162 166 677. CONCLUSIONS: Acknowledging that these are likely to be the most rare but most seriously affected cases, the clinical themes arising from these cases should be used for further development of training and guidance to reduce harm and redivert NHS funds from litigation to direct care.

The Role of Documentation Quality in Anesthesia-Related Closed Claims: A Descriptive Qualitative Study.

Clinical documentation is a critical tool in supporting care provided to patients. Sound documentation provides a picture of clinical events that can be used to improve patient care. However, many other uses for clinical documentation are equally important. Such documentation informs clinical decision support tools, creates a legal record of patient care, assists in financial reimbursement of services, and serves as a repository for secondary data analysis. Conversely, poor documentation can impair patient safety and increase malpractice risk exposure by reflecting poor or inaccurate information that ultimately may guide patient care decisions.Through an examination of anesthesia-related closed claims, a descriptive qualitative study emerged, which explored the antecedents and consequences of documentation quality in the claims reviewed. A secondary data analysis utilized a database generated by the American Association of Nurse Anesthetists Foundation closed claim review team. Four major themes emerged from the analysis. Themes 1, 2, and 4 primarily describe how poor documentation quality can have negative consequences for clinicians. The third theme primarily describes how poor documentation quality that can negatively affect patient safety.

Audit Today, Revocation Tomorrow?

Federal regulations grant the Centers for Medicare & Medicaid Services (CMS) the authority to revoke a healthcare provider's Medicare billing privileges for submitting claims for services that could not have been provided on the purported date of service, such as billing for deceased beneficiaries. A Final Rule became effective in 2015 extending the authority of CMS to revoke a provider's billing privileges if CMS determines that the provider has a pattern or practice of billing for services that do not meet Medicare requirements. Violations under the Final Rule include situations in which a provider regularly and repeatedly submits claims for medically unnecessary services. While historically a provider's noncompliance exposed the provider to overpayment refund demands resulting from CMS audit activity, this new revocation authority emphasizes an even greater need for providers to ensure their billing and documentation practices are in compliance with Medicare reimbursement requirements.

Wrist and scaphoid fractures: a 17-year review of NHSLA litigation data.

Wrist and scaphoid fractures are common injuries seen and treated in everyday orthopaedic practice. The purpose of the study was to assess the trends and reasons for litigation related to wrist and scaphoid fractures within the NHS. Under a freedom of information (FOI) request, data from 1995 to 2012 were provided by the National Health Service Litigation Authority (NHSLA) on all litigation claims made as a result of wrist and scaphoid fractures. A total of 1354 claims relating to the hand and wrist were identified. Wrist and scaphoid fractures accounted for 492 (36.3%) of these claims, and 365 of these claims were settled, representing 74.2% of all wrist and scaphoid fracture claims. Overall, the most common reason for lost claims was due to incorrect, missed or delayed diagnosis (43.5%). Alleged mismanagement (29.5%), poor care (10.1%) and incompetent surgery (8.0%) were other common causes for litigation. This paper augments previous work published in this area and explores litigation trends specific to wrist and scaphoid fractures. We discuss the trends and reasons for litigation in this area, suggesting areas for improvement that may aid health-care professionals who deal with these injuries and potentially help reduce future litigation.

Greatest impact of safe harbor rule may be to improve patient safety, not reduce liability claims paid by physicians.

"Safe harbor" legislation that provides liability protection to physicians when they follow designated guidelines is often proposed as a way to reform the malpractice system while improving patient safety. However, published evidence provides little policy guidance on implementing safe harbors. With the support of an Agency for Healthcare Research and Quality planning grant, we conducted an empirical analysis of closed liability claims in Oregon to determine the potential effects of hypothetical safe harbor legislation. We found that such legislation would have changed the liability outcome in favor of the physician defendant in only 1 percent of 266 claims from the period 2002-09 that we reviewed. Nevertheless, if safe harbors can induce greater physician adherence to care guidelines, they have the potential to improve patient safety. Implementing safe harbor legislation, however, requires overcoming a number of hurdles, including selecting and updating approved guidelines, obtaining broad stakeholder support, and withstanding challenges to the legal validity of the legislation. More experimentation with safe harbors is needed to determine their effects on the performance of the liability system and on health care quality and costs.