Transmitting Device Identifiers of Implants From the Point of Care to Insurers: A Demonstration Project.

BACKGROUND: For implanted devices, an effective postmarket surveillance system does not exist. For medications, the Food and Drug Administration's Sentinel Initiative plays that role, relying mainly on drug codes in insurance claims. Unique device identifiers (UDIs) could play an analogous role for implants, but there is no mandate for providers to include UDIs in claims or for payers to record them. Objections have been raised to incorporating UDIs into claims based on a potential burden on providers. METHODS: To assess this purported barrier, we modified information systems at 2 provider-payer dyads to allow for the transmission of UDI data from provider to payer. In addition, to illustrate the potential benefit of including device data in claims, we used our data to compare rates of 90-day adverse events after implantation using the electronic health record (EHR) alone with the EHR plus claims. RESULTS: The software system modifications were modest and performed as designed. Moreover, the level of difficulty of their development and implementation was comparable to that associated with a typical new release of an existing system. In addition, our data demonstrated the ability of claims-based data plus EHR data to reveal a larger percentage of postprocedure adverse events than data from EHRs alone. CONCLUSIONS: Modifying information systems to allow for the transmission of UDI data from providers to payers should not impose a substantial burden on either. Implementation of a postmarket surveillance system based on such data in claims will require, however, the development of a system analogous to Sentinel.

UDI2Claims: Planning a Pilot Project to Transmit Identifiers for Implanted Devices to the Insurance Claim.

BACKGROUND: In response to problems with the current postmarket surveillance of medical devices, the U.S. Food and Drug Administration mandated device labelers to include a unique device identifier (UDI), composed of a device identifier (DI) and production identifier. Including the DI in insurance claims could be a potent method to monitor implanted devices, yet implementation has lagged because of questions of benefit and operational concerns. METHODS: To illustrate the potential benefit of including DIs in claims, rates of 90-day adverse events after implantation using an electronic health record (EHR) were compared with the EHR plus claims, which capture utilization outside that EHR's health system. To explore operations, we planned a pilot project to transmit the DI of implanted devices from the point of care to the claim at two provider/payer pairs. RESULTS: By querying claims plus EHR, estimated rates of patients with potential adverse events were as much as 3.75 times higher. For our pilot, our multistakeholder team identified and resolved the following five challenges: (1) capturing the DI at the point of care; (2) selecting a location for the DI on the claim form; (3) transmitting the DI to the claim form; (4) analyzing the claim forms received by the payer; and (5) verifying the quality of the transmitted information. CONCLUSIONS: Including DIs on claims could allow more complete data capture of adverse events for implanted devices than the EHR data. We overcame challenges in transmitting the DI to the claim with attention to planning and multistakeholder involvement.

Impact of the Affordable Care Act on trauma and emergency general surgery: An Eastern Association for the Surgery of Trauma systematic review and meta-analysis.

BACKGROUND: Trauma and emergency general surgery (EGS) patients who are uninsured have worse outcomes as compared with insured patients. Partially modeled after the 2006 Massachusetts Healthcare Reform (MHR), the Patient Protection and Affordable Care Act was passed in 2010 with the goal of expanding health insurance coverage, primarily through state-based Medicaid expansion (ME). We evaluated the impact of ME and MHR on outcomes for trauma patients, EGS patients, and trauma systems. METHODS: This study was approved by the Eastern Association for the Surgery of Trauma Guidelines Committee. Using Grading of Recommendations Assessment, Development and Evaluation methodology, we defined three populations of interest (trauma patients, EGS patients, and trauma systems) and identified the critical outcomes (mortality, access to care, change in insurance status, reimbursement, funding). We performed a systematic review of the literature. Random effect meta-analyses and meta-regression analyses were calculated for outcomes with sufficient data. RESULTS: From 4,593 citations, we found 18 studies addressing all seven predefined outcomes of interest for trauma patients, three studies addressing six of seven outcomes for EGS patients, and three studies addressing three of eight outcomes for trauma systems. On meta-analysis, trauma patients were less likely to be uninsured after ME or MHR (odds ratio, 0.49; 95% confidence interval, 0.37-0.66). These coverage expansion policies were not associated with a change in the odds of inpatient mortality for trauma (odds ratio, 0.96; 95% confidence interval, 0.88-1.05). Emergency general surgery patients also experienced a significant insurance coverage gains and no change in inpatient mortality. Insurance expansion was often associated with increased access to postacute care at discharge. The evidence for trauma systems was heterogeneous. CONCLUSION: Given the evidence quality, we conditionally recommend ME/MHR to improve insurance coverage and access to postacute care for trauma and EGS patients. We have no specific recommendation with respect to the impact of ME/MHR on trauma systems. Additional research into these questions is needed. LEVEL OF EVIDENCE: Review, Economic/Decision, level III.

Effect of Medicaid Expansion on Colorectal Cancer Screening Rates.

BACKGROUND: Colorectal cancer screening decreases incidence and improves survival. Minorities and low-income patients have lower screening rates. The Affordable Care Act increased insurance coverage for low-income Americans by funding Medicaid expansion. Not all states expanded Medicaid. The effect of Medicaid expansion on colorectal cancer screening is unknown. OBJECTIVE: This study aimed to evaluate if Medicaid expansion improved colorectal cancer screening for minorities and low-income patients. DESIGN: We used the Behavior Risk Factor Surveillance System, a nationally representative health-related telephone survey, to compare colorectal cancer screening rates from 2012 to 2016 based on Medicaid expansion status. A difference-in-difference analysis was used to compare the trends. SETTINGS: All states were included in this survey. PATIENTS: Respondents aged 50 to 64 from the early expansion, 2014 expansion, and nonexpansion states were selected. INTERVENTIONS: Medicaid expansion was funded by the Affordable Care Act. MAIN OUTCOME MEASURES: The primary outcome measured was the screening rate based on US Preventive Services Task Force guidelines. RESULTS: Overall screening in expansion states increased (early, +4.5%, p < 0.001; 2014, +1.3%, p = 0.17) compared with nonexpansion states. Screening among low-income respondents increased in early expansion states (+5.7%; p = 0.003), whereas there was no change in 2014 expansion states compared with nonexpansion states (2014, -0.3%, p = 0.89). For blacks, there was a significant increase in early expansion states, but no change in 2014 expansion states (early, +8.1%, p = 0.045; 2014, -1.5%, p = 0.64). There was no significant change for Hispanic respondents in early or 2014 expansion states compared with nonexpansion states (early, +6.5%, p = 0.11; 2014, +1.2%, p = 0.77). LIMITATIONS: Survey data are subject to response and recall bias. Factors other than Medicaid expansion may have influenced the screening rate. CONCLUSIONS: The colorectal cancer screening rate has increased in all settings, but expansion accelerated the increases in early expansion states and among low-income and black respondents; however, there was no similar increase for Hispanic respondents. It will be important to continue to monitor the effects of Medicaid expansion on colorectal cancer care, especially the incidence by stage and mortality. See Video Abstract at http://links.lww.com/DCR/A792.

General surgery education: a systematic review of training worldwide.

BACKGROUND: Surgical care is an essential component of health management worldwide. As the prevalence of injuries and non-communicable diseases increases, the provision of effective surgical care will become an increasingly important priority to reduce death and disability. To assess the ability of health systems to meet current surgical needs, we did a review of surgical training programmes worldwide. METHODS: We searched Medline, EMBASE, and the Global Health Library databases with the search terms "surgical training" and "surgeon training" for abstracts and citations in all languages published between Jan 1, 1998, and Dec 31, 2013, describing a national general surgery training system. We extracted the following data: a brief description of the programme, years of training required, year after medical school graduation when training begins, name of national oversight organisation(s), in-country opportunities for subspecialty training, and whether programmes self-identified as being similar to or affected by the surgical education system in the USA or the UK. FINDINGS: We identified 5229 abstracts (3888 from Medline, 971 from EMBASE, and 726 from the Global Health Library databases). 228 (4·4%) articles underwent full text review. 60 articles were included for data extraction. We identified descriptions of general surgery training programmes in 52 countries. Data from an additional 17 countries represented by a regional college of surgeons were also recorded. Training duration ranged from 2-8 years (median total training, 6 years; median surgical training, 5 years), and lasted on average 6 years after medical school graduation. 19 countries self-identified as being similar to or affected by the US or UK training model. Many low-income and middle-income countries (LMICs) are working to expand access to surgical care through programmes, often focusing on training non-physician clinicians. Programmes in high-income countries have also undergone substantial reforms, affected by evolving practice environments, trainee preferences, and training bottlenecks. INTERPRETATION: General surgery training programmes are often responsive to national health care needs. We show a global trend towards standardisation of curricula and competency-based training. Countries expanding or developing their programmes show benefit from association or partnership with larger surgical organisations and academic institutions, but there are questions of sustainability. Both LMICs and high-income countries stand to benefit from coordinating development of global training standards and educational exchanges. Although more research is needed to understand the role of surgical education in meeting the demand for surgical care, it is clear that a cross-nationally coordinated strategy will be important to address the burden of surgical disease. FUNDING: None.