Minced Cartilage in Combination with Autologous Bone Grafting for One-Step Osteochondral Defect Reconstruction in an Athlete’s Knee

A 17-year-old student athlete suffering from stress-related knee pain asked for help. MRI revealed an unstable osteochondral lesion. Because of time pressure due to the patient’s academic exams and his schedule as a basketball player, an autologous chondrocyte transplantation (ACT) as the standard surgical treatment plan was not accepted by the patient. This was mainly because of its two-step character three weeks in between surgeries. Therefore, a surgical one-step therapy option as alternative treatment to ACT was needed. The patient received simultaneous autologous cancellous bone grafting and minced cartilage procedure in a sandwich technique. After successful rehabilitation, the patient continued his studies of sports science and his active career as a basketball player successfully. Several different procedures are used for the treatment of cartilage defects. The following factors play a significant role: defect size, location, patient age, and sports ambitions. In the case described here, ACT would have been the conventional, but not the ideal option in the perspective of this individual patient because of the two-step surgery and the longer rehabilitation time. Therefore, the minced cartilage method presented a valid alternative, even though long-term data are still missing and prospective studies comparing this procedure with others are needed in the future.

Saphenion®: Oxygen Multi-Step Therapy in Varicose Veins: Improvement of the Microcirculation- Our Prospective Study Results in 118 Cases Over 6 Months

Oxygen multi-step therapy for Varicose Veins: Oxygen as an energy carrier, all mechanisms in the human organism during growth, its maintenance and its physical and mental activity require energy. This becomes particularly clear to the patient during cardiac work, breathing work in the lungs, skeletal muscles and intellectual work. The pathology of the microcirculation in the capillaries depends largely on the oxygen partial pressure and on the blood pressure in the supplying arteries and the high pressure in the draining veins.

Influence of Prior Authorization Requirements on Provider Clinical Decision Making

Background: Prior authorization (PA) of medications is widely used by payers in the United States as a way to promote safe and effective use of medications and to control costs. However, PA-related tasks such as completing forms, submitting forms, researching medical history and submitting required documentation can all contribute to burden on healthcare providers. This study examines how such tasks and affect provider burden and treatment decisions. Methods: We developed and administered a nationwide, cross-sectional online survey of medical providers in the United States in 2020 based on a convenience sample of 100,000 providers (physicians, nurse practitioners, and physician assistants). Path analysis was used to test the associations between provider practice characteristics, step therapy and other health plan requirements, perceived burdens of PA, and communication issues with insurers on prescribing behaviors, which included prescribing a different medication, avoiding prescribing of newer medications, and modifying a diagnosis. Weighted analyses were also conducted to account for sample bias due to non-response. Results: A total of 1173 providers (1.2% response rate) provided 1147 usable surveys. The sample was 49.6% female, and a majority were MD/DO providers (85%). Step therapy requirements had the largest influence on prescribing a different medication than planned (b = .22, 95% CI = .160-.285) and avoiding prescribing a newer medication despite meeting evidence-based guidelines (b = .24, 95% CI = .181-.309). A unit-weighted index of perceived PA burden risk was associated with prescribing a different medication (b = .09, 95% CI = .012-.128) and modifying a diagnosis to obtain PA approval (b = .14, 95% CI = .065-.195). Communication issues were associated with prescribing a different medication (b = .11, 95% CI = .029-.186), while health plan requirements (e.g., clinical documentation) was significantly associated with all three prescribing outcomes. Weighted analyses showed that the study conclusions were unlikely to have been biased by nonresponse. Conclusions: Providers report altering prescribing and modifying diagnoses to avoid PA requirements and related burdens. Processes that reduce the administrative burden of PA through improved communication and transparency as well as standardized documentation may help ensure that PA more seamlessly achieves its goals of safe and effective use of medications. Trial Registration: NA Keywords: clinical decision making, health plan, prior authorization, provider burden, specialty types, workaroundsTrial Registration: NA

Association Between Pharmacy Benefit Restrictions and Disease-Modifying Therapy Use in the Medicare Part D Program

Objective:To determine the association between Medicare Part D Plan disease-modifying therapy (DMT) restrictiveness and adherence and outcomes among people with multiple sclerosis (MS)Methods:We used Medicare claims data from 2010 to 2014 to identify individuals with a full year enrollment (Part A, B, D), an MS diagnosis, and one or more self-administered DMT prescription. Plans were considered restrictive if all available DMTs required a prior authorization or step therapy restriction; otherwise they were considered permissive. We compared DMT adherence, defined as a medication possession ratio (MPR) >=80%, MS-related emergency department (ED) or inpatient admissions, and outpatient visits by Part D plan restrictiveness. We used multivariate regression models to control for patient demographics and comorbidities.Results:There were 37,713 Medicare beneficiaries with MS who were enrolled in either restrictive (n=29,901) or permissive (n=7812) Part D plans during the study period. Patients enrolled in restrictive plans were older (60 versus 58 years; p<.001), more likely to live in the south (38% vs 23%; p<.001), eligible through disability (67% vs 60%; p<.001), and more likely to have several chronic comorbid conditions. Patients enrolled in restrictive plans were less likely to be adherent to their DMT (54% vs 57%; p<0.001; adjusted odds ratio [aOR] 0.92, 95% confidence interval [CI] 0.88 to 0.98] and had a higher rate of MS-related outpatient visits (1.7 vs 1.4 per year; p<.001; adjust rate ratio (aRR) 1.27, 95% CI 1.23 to 1.31).Conclusions:Medicare beneficiaries with MS enrolled in restrictive Part D plans were less adherent to their DMT and had higher rates of MS-related outpatient visits.

Do patients benefit from legislation regulating step therapy?

Step therapy, also termed fail-first policy, describes a practice of insurance and pharmacy benefit management companies denying reimbursement for a specific treatment until after other treatments have first been found ineffective (i.e. failed). Laws to limit step therapy have been passed in 29 states of the United States. Using extrapolated data on fully insured employees, we find that except for New York and New Mexico, enacted State laws don't apply to even one-third of a state's population. Using the more robust Kaiser Family Foundation (KFF) data, which do not include fully insured employees, we find that only 2–10% of a state's population is covered. Advocating for these laws has been an expensive and time-consuming process, likely to become more so for the 21 states without such laws. The laws that have been enacted can be near impossible, to enforce, and loopholes exist. As a result, using KFF data, more than 90% of people in the United States with health insurance may still be unable to access the treatment chosen as most appropriate for them with their physician. Based on these data, we conclude federal step-therapy legislation is needed.

Outbreak of Enterovirus Infection with Neurological Presentations in a Pediatric Population in Northern Spain: A Clinical Observational Study

Objective The study aimed to describe the cases of neurological disease related to the outbreak of enterovirus (EV) in three regions in Northern Spain during 2016. Materials and Methods Multicenter retrospective observational study. Clinical, radiological, and microbiological data were analyzed from patients younger than 15 years with confirmed EV-associated neurological disease admitted to 10 hospitals of Asturias, Cantabria, and Castile and Leon between January 1 and December 31, 2016. Results Fifty-five patients were included. Median age was 24 months (interquartile range = 18.5 months). Fifteen patients were classified as aseptic meningitis (27.3%). In total, 37 cases presented brainstem encephalitis (67.3%), 25 of them due to EV-A71 with excellent prognosis (84.6% asymptomatic 2 months following the onset). Three cases of acute flaccid myelitis (5.5%) by EV-D68 were reported and presented persistent paresis 2 months following the onset. Microbiological diagnosis by reverse transcriptase polymerase chain reaction was performed in all cases, finding EV in cerebrospinal fluid in meningitis, but not in brainstem encephalitis and acute flaccid myelitis, where EV was found in respiratory or rectal samples. Step therapy was administrated with intravenous immunoglobulin (IVIG; 32.7%), methylprednisolone (10%), and plasmapheresis (3.6%). Four patients received fluoxetine (7.3%). Twenty patients needed to be admitted to pediatric intensive care unit (36.4%). Conclusion Clinical, microbiological, and radiological diagnosis is essential in outbreaks of EV neurological disease, taking into account that it can be difficult to identify EV-A71 and EV-D68 in CSF, requiring throat or rectal samples. There is not specific treatment to these conditions and the efficacy and understanding of the mechanism of action of immune-modulatory treatment (IVIG, corticosteroids, and plasmapheresis) is limited.

Cornerstones of ‘fair’ drug coverage: appropriate cost sharing and utilization management policies for pharmaceuticals

At the heart of all health insurance programs lies ethical tension between maximizing the freedom of patients and clinicians to tailor care for the individual and the need to make healthcare affordable. Nowhere is this tension more fiercely debated than in benefit design and coverage policy for pharmaceuticals. This paper focuses on three areas over which there is the most controversy about how to judge whether drug coverage is appropriate: cost-sharing provisions, clinical eligibility criteria, and economic-step therapy and required switching. In each of these domains we present ‘ethical goals for access’ followed by a series of ‘fair design criteria’ that can be used by stakeholders to drive more transparent and accountable drug coverage.