Editorial Commentary: Bioinductive Collagen Implants Reduce Rotator Cuff Retear, yet Cost-Effectiveness and Improvement in Clinical Outcomes Are Unclear.

The estimated health care costs of failed arthroscopic rotator cuff retears (RCRs) performed in the United States represent a huge economic burden of greater than $400 million per 2-year period. Unfortunately, retear rates do not appear to have improved significantly since the 1980s, despite advances in surgical technology and the biomechanics of repair. The failure of these advances to translate into improved clinical results suggests that the limiting step in reducing retear rates is biology rather than the biomechanics of repair. Bioinductive collagen implants (BCIs) are an emerging and potentially useful option for biological augmentation. Recent meta-analysis of preclinical and clinical studies demonstrates that biological augmentation significantly lowers the risk of retear. Retrieval studies from human RCR subjects who underwent treatment with BCI demonstrate cellular incorporation, tissue formation, and maturation, providing a logical basis for a reduction in retear rates as well as small increases in tendon thickness at the footprint. Although BCIs show potential as a possible game-changing solution for reducing failure rates of RCR, concerns remain regarding cost-effectiveness analyses and demonstration of functional outcome improvement.

Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy in Patients With Heart Failure and Secondary Mitral Regurgitation: Results From the COAPT Trial.

BACKGROUND: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip resulted in reduced mortality and heart failure hospitalizations and improved quality of life compared with maximally tolerated guideline-directed medical therapy (GDMT) in patients with heart failure and 3 to 4+ secondary mitral regurgitation. Whether TMVr is cost-effective compared with GDMT in this population is unknown. METHODS: We used data from the COAPT trial to perform a formal patient-level economic analysis of TMVr+GDMT versus GDMT alone for patients with heart failure and 3 to 4+ secondary mitral regurgitation from the perspective of the US healthcare system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated on the basis of medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline and 1, 6, 12, and 24 months with the Short Form Six-Dimension Health Survey. RESULTS: Initial costs for the TMVr procedure and index hospitalization were $35 755 and $48 198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26 654 versus $38 345; P=0.018), cumulative 2-year costs remained higher with TMVr because of the upfront cost of the index procedure ($73 416 versus $38 345; P<0.001). When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life expectancy by 1.13 years and quality-adjusted life-years by 0.82 years at a cost of $45 648, yielding a lifetime incremental cost-effectiveness ratio of $40 361 per life-year gained and $55 600 per quality-adjusted life-year gained. CONCLUSIONS: For symptomatic patients with heart failure and 3 to 4+ secondary mitral regurgitation, TMVr increases life expectancy and quality-adjusted life expectancy compared with GDMT at an incremental cost per quality-adjusted life-year gained that represents acceptable economic value according to current US thresholds. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

Magnetic Resonance Examinations of Patients With Implanted Active Devices. A Low-Cost Approach in Slew Rate Evaluation.

Time-varying magnetic field gradients involved in magnetic resonance examinations can damage implanted electronic systems. The quantity related to this side effect is the gradient slew rate, which is usually not directly available on magnetic resonance console. The present study proposes a low-cost approach in slew rate assessment, which is useful in risks versus benefits evaluation as well as in sequences optimization. The experimental method is based on an analog circuit, which senses the output voltage of the scanner waveform generator. This allows taking easy and reliable slew rate measurements, even during clinical examinations on patients. Whereas previous studies required managing a considerable amount of data, the present work addresses only the maximal slew rate of any clinical sequence. Experimental results show that the smooth gradient mode, selectable on the two scanners examined, is very effective in patient safety improvement. In particular, it reduces slew rate values in the range from 52.4 up to 132.4 T m-1 s-1 , i.e. far below the interval 216-346 T m-1 s-1 , indicated as slew rate tolerance limit of modern implanted electronic devices. Bioelectromagnetics. 2019;40:512-521. © 2019 Bioelectromagnetics Society.

Polymethyl Methacrylate in Patient-Specific Implants: Description of a New Three-Dimension Technique.

Polymethyl methacrylate (PMMA), an easily moldable and economical synthetic resin, has been used since the 1940s. In addition, PMMA has good mechanical properties and is one of the most biocompatible alloplastic materials currently available. The PMMA can serve as a spacer and as a delivery vehicle for antibiotics. Prior studies have indicated that no significant differences in infection rates exist between autologous and acrylic cranioplasty. Although inexpensive, the free-hand cranioplasty technique often yields unsatisfactory cosmetic results. In the present study, the application of a recently developed, economic modality for the perioperative application, and molding of PMMA to ensure a precise fit in 16 patients using computer-aided design, computer-aided manufacturing, and rapid prototyping was described.The mean defect size was 102.0 ±â€Š26.4 cm. The mean volume of PMMA required to perform the cranioplasty procedure was 51 mL. The cost of PMMA was approximately 6 Euro (&OV0556;) per mL. The costs of fabricating the implants varied from 119.8 &OV0556; to 1632.0 &OV0556; with a mean of 326.4 &OV0556; ±â€Š371.6. None of the implants required removal during the follow-up period.

3D printing for low cost, rapid prototyping of eyelid crutches.

Blepharoptosis or ptosis is a common and potentially debilitating clinical problem. Long-term surgical treatment for ptosis caused by progressive myopathies can be challenging due to potential recurrence and complications associated with facial muscle weakness. When surgical treatment is no longer effective, an eyelid crutch can be used as an alternative intervention. This report demonstrates how 3D printing was used to rapidly design, prototype, and manufacture new custom-fit eyelid crutches at a low cost.

The use of mesh for inguinal hernia repair in northern Ghana.

BACKGROUND: Despite the recognition that inguinal hernia (IH) repair is cost-effective, repair rates in low- and middle-income countries remain low. Estimated use of mesh in low- and middle-income countries also remains low despite publications about low-cost, noncommercial mesh. The purpose of our study was to assess the current state of IH repair in the northern and transitional zone of Ghana. MATERIALS AND METHODS: A retrospective review of surgical case logs of IH repairs from 2013 to 2017 in 41 hospitals was performed. Multivariate logistic regression was used to determine predictors of mesh use. RESULTS: Eight thousand eighty male patients underwent IH repair. The range of IH repair in each region was 96 to 295 (overall 123) per 100,000 population. Most cases were performed at district hospitals (84%) and repaired nonurgently (93%) by nonsurgeon physicians (66%). Suture repair was most common (85%) although mesh was used in 15%. The strongest predictor of mesh use was when a surgeon performed surgery (odds ratio [OR] 3.13, P <0.001), followed by surgery being performed in a teaching hospital (OR 2.31, P <0.001). Repair at a regional hospital was a negative predictor of mesh use (OR 0.08, P <0.001) as was the use of general anesthesia (OR 0.40, P = 0.001). CONCLUSIONS: Most IH repairs are performed in district hospitals, by nonsurgeon physicians, and without mesh. Rates of repair and the use of mesh are higher than previous estimates in Ghana and Sub-Saharan Africa but not as high as high-income countries.

Economic value of orthotic and prosthetic services among medicare beneficiaries: a claims-based retrospective cohort study, 2011-2014.

BACKGROUND: There are few studies of the economic value of orthotic and prosthetic services. A prior cohort study of orthotic and prosthetic Medicare beneficiaries based on Medicare Parts A and B claims from 2007 to 2010 concluded that patients who received timely orthotic or prosthetic care had comparable or lower total health care costs than a comparison group of untreated patients. This follow-up study reports on a parallel analysis based on Medicare claims from 2011 to 2014 and includes Part D in addition to Parts A and B services and expenditures. Its purpose is to validate earlier findings on the extent to which Medicare patients who received select orthotic and prosthetic services had less health care utilization, lower Medicare payments, and potentially fewer negative outcomes compared to matched patients not receiving these services. METHODS: This is a retrospective cohort analysis of 78,707 matched pairs of Medicare beneficiaries with clinical need for orthotic and prosthetic services (N = 157,414) using 2011-2014 Medicare claims data. It uses propensity score matching techniques to control for observable selection bias. Economically, a cost-consequence evaluation over a four-year time horizon was performed. RESULTS: Patients who received lower extremity orthotics had 18-month episode costs that were $1939 lower than comparable patients who did not receive orthotic treatment ($22,734 vs $24,673). Patients who received spinal orthotic treatment had 18-month episode costs that were $2094 lower than comparable non-treated patients ($23,560 vs $25,655). Study group beneficiaries receiving both types of orthotics had significantly lower Part D spending than those not receiving treatment (p < 0.05). Patients who received lower extremity prostheses had comparable 15-month episode payments to matched beneficiaries not receiving prostheses ($68,877 vs $68,893) despite the relatively high cost of the prosthesis. CONCLUSIONS: These results were consistent with those found in the prior study and suggest that orthotic and prosthetic services provide value to the Medicare program and to the patient.

Design and Simulation of an Integrated Wireless Capacitive Sensors Array for Measuring Ventricular Pressure.

This paper reports the novel design of a touch mode capacitive pressure sensor (TMCPS) system with a wireless approach for a full-range continuous monitoring of ventricular pressure. The system consists of two modules: an implantable set and an external reading device. The implantable set, restricted to a 2 × 2 cm² area, consists of a TMCPS array connected with a dual-layer coil, for making a reliable resonant circuit for communication with the external device. The capacitive array is modelled considering the small deflection regime for achieving a dynamic and full 5⁻300 mmHg pressure range. In this design, the two inductive-coupled modules are calculated considering proper electromagnetic alignment, based on two planar coils and considering the following: 13.56 MHz frequency to avoid tissue damage and three types of biological tissue as core (skin, fat and muscle). The system was validated with the Comsol Multiphysics and CoventorWare softwares; showing a 90% power transmission efficiency at a 3.5 cm distance between coils. The implantable module includes aluminum- and polyimide-based devices, which allows ergonomic, robust, reproducible, and technologically feasible integrated sensors. In addition, the module shows a simplified and low cost design approach based on PolyMEMS INAOE® technology, featured by low-temperature processing.

Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment. Update to list.

This document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment. Prior authorization for these codes will be implemented nationwide.

Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary Utilization. Master list deletions.

This document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.

Percutaneous Kirschner Wire Versus Commercial Implant for Hammertoe Repair: A Cost-Effectiveness Analysis.

Hammertoe deformities are one of the most common foot deformities, affecting up to one third of the general population. Fusion of the joint can be achieved with various devices, with the current focus on percutaneous Kirschner (K)-wire fixation or commercial intramedullary implant devices. The purpose of the present study was to determine whether surgical intervention with percutaneous K-wire fixation versus commercial intramedullary implant is more cost effective for proximal interphalangeal joint arthrodesis in hammertoe surgery. A formal cost-effectiveness analysis using a decision analytic tree model was conducted to investigate the healthcare costs and outcomes associated with either K-wire or commercial intramedullary implant fixation. The outcomes assessed included long-term costs, quality-adjusted life-years (QALYs), and incremental cost per QALY gained. Costs were evaluated from the healthcare system perspective and are expressed in U.S. dollars at a 2017 price base. Our results found that commercial implants were minimally more effective than K-wires but carried significantly higher costs. The total cost for treatment with percutaneous K-wire fixation was $5041 with an effectiveness of 0.82 QALY compared with a commercial implant cost of $6059 with an effectiveness of 0.83 QALY. The incremental cost-effectiveness ratio of commercial implants was $146,667. With an incremental cost-effectiveness ratio of >$50,000, commercial implants failed to justify their proposed benefits to outweigh their cost compared to percutaneous K-wire fixation. In conclusion, percutaneous K-wire fixation would be preferred for arthrodesis of the proximal interphalangeal joint for hammertoes from a healthcare system perspective.

Senate inquiry into price regulation on the prostheses list.

A recent Senate Inquiry investigated the Prostheses List (PL) which has been an integral part of the private health care system since its introduction in 1985. The PL sets the price of various prostheses products available for private health insurance patients. In recent years however, the PL has come under scrutiny due to the inflated prices of prostheses, lack of transparency from the list's creators and regulators, and increased premiums. This column critically analyses the recent Senate report, particularly as to whether it appropriately addressed the various concerns and issues raised in submissions and terms of reference of the inquiry and what ongoing role the PL should have in the Australian Healthcare System.

Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey.

Decisions to adopt medical devices at the hospital level have consequences for health technology assessment (HTA) on system level and are therefore important to decision makers. Our aim was to investigate the characteristics of organizations and individuals that are more inclined to adopt and utilize cardiovascular devices based on a comprehensive analysis of environmental, organizational, individual, and technological factors and to identify corresponding implications for HTA. Seven random intercept hurdle models were estimated using the data obtained from 1249 surveys completed by members of the European Society of Cardiology. The major findings were that better manufacturer support increased the adoption probability of 'new' devices (i.e. in terms of CE mark approval dates), and that budget pressure increased the adoption probability of 'old' devices. Based on our findings, we suggest investigating the role of manufacturer support in more detail to identify diffusion patterns relevant to HTA on system level, to verify whether it functions as a substitute for medical evidence of new devices, and to receive new insights about its relationship with clinical effectiveness and cost-effectiveness. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

The Effect of Price on Surgeons' Choice of Implants: A Randomized Controlled Survey.

PURPOSE: Surgical costs are under scrutiny and surgeons are being held increasingly responsible for cost containment. In some instances, implants are the largest component of total procedure cost, yet previous studies reveal that surgeons' knowledge of implant prices is poor. Our study aims to (1) understand drivers behind implant selection and (2) assess whether educating surgeons about implant costs affects implant selection. METHODS: We surveyed 226 orthopedic surgeons across 6 continents. The survey presented 8 clinical cases of upper extremity fractures with history, radiographs, and implant options. Surgeons were randomized to receive either a version with each implant's average selling price ("price-aware" group), or a version without prices ("price-naïve" group). Surgeons selected a surgical implant and ranked factors affecting implant choice. Descriptive statistics and univariate, multivariable, and subgroup analyses were performed. RESULTS: For cases offering implants within the same class (eg, volar locking plates), price-awareness reduced implant cost by 9% to 11%. When offered different models of distal radius volar locking plates, 25% of price-naïve surgeons selected the most expensive plate compared with only 7% of price-aware surgeons. For cases offering different classes of implants (eg, plate vs external fixator), there was no difference in implant choice between price-aware and price-naïve surgeons. Familiarity with the implant was the most common reason for choosing an implant in both groups (35% vs 46%). Price-aware surgeons were more likely to rank cost as a factor (29% vs 21%). CONCLUSIONS: Price awareness significantly influences surgeons' choice of a specific model within the same implant class. Merely including prices with a list of implants leads surgeons to select less expensive implants. This implies that an untapped opportunity exists to reduce surgical expenditures simply by enhancing surgeons' cost awareness. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic/Decision Analyses I.

Drivers of the Variation in Prosthetic Implant Purchase Prices for Total Knee and Total Hip Arthroplasties.

BACKGROUND: Previous studies have documented wide variation in health care spending and prices; however, the causes for the variation in supply purchase prices across providers are not well understood. The purpose of this study was to determine the drivers of variation in prosthetic implant purchase prices for primary total knee and hip arthroplasties (TKA and THA, respectively) across providers. METHODS: We obtained retrospective data from 27 hospitals on the average prosthetic implant purchase prices for primary TKAs and THAs over the 12 months ending September 30, 2013, as well as data on a range of independent potential explanatory variables. Each hospital performed at least 200 primary total joint arthroplasties per year. The multivariate seemingly unrelated regression approach was used to evaluate the impact of the variables on purchase price for each type of implant. RESULTS: The average purchase price at the hospital at the 90th percentile was 2.1 times higher for TKAs and 1.7 times higher for THAs than that at the hospital at the 10th percentile. The use of a hospital-physician committee for implant vendor selection and negotiation was associated with 17% and 23% lower implant purchase prices (P < .05) for TKAs and THAs, respectively, relative to hospitals that did not have this collaborative approach. CONCLUSION: The use of a joint hospital-physician committee is a potential strategy for achieving lower average purchase prices for prosthetic implants. Policies to increase hospital-physician collaboration may lead to lower average purchase prices in this market.

Analyzing the Cost of Autogenous Cranioplasty Versus Custom-Made Patient-Specific Alloplastic Cranioplasty.

PURPOSE: Comparing expenses related to autogenous cranial vault reconstruction versus custom-made patient-specific alloplastic cranioplasty. METHODS: The authors retrospectively reviewed charts of a group of patients who underwent autogenous cranioplasty and poly-ether-ether ketone (PEEK) cranioplasty. The data collected from the patient files included demographic information, details of the surgery, postoperative recovery data, and also duration of surgery. The authors also added costs related to the length of surgery, utilization of intensive care unit, length of hospital stay, amount and seriousness of complications, and hardware cost. The outcomes were studied in terms of skull form maintenance and complications.Eleven of our patients had PEEK cranioplasty at Sunnybrook Hospital, Toronto, ON, in the period from July 2009 to June 2011. The authors identified 11 patients who had split skull autogenous bone graft cranioplasty. They were matched for age and skull defect size.Comparable information was collected for both patient groups. The information was examined to compare costs of custom-made patient-specific alloplastic implants and costs of autogenous cranioplasty. RESULTS: Conclusions made from this paper will hopefully serve as guidance for allocation of hospital funding and resources at the Ministry of Health level.

[Economic evaluation of medical devices not included in the French list of products and services qualifying for reimbursement: Example of biologic meshes]. / Impact économique à l'hôpital de dispositifs médicaux non remboursés en sus des GHS : exemple des prothèses de renfort biologiques.

OBJECTIVES: To present a method aimed to evaluate the economic impact associated with the use of medical devices (DM) not reimbursed in addition to diagnosis related groups (DRGs) tariffs using the example of biological meshes for parietal reinforcement. METHODS: In this multicenter retrospective cohort study, we included all patients who received a biological mesh between January 2010-April 2014 (University hospitals of Saint-Étienne, France) or between January 2010-March 2015 (Lyon University hospitals, France). Measured costs associated with biologic meshes were compared to those of the "Étude nationale des coûts à méthodologie commune" (2012) to weigh the economic impact of biologic meshes with the French DRGs costs. We also compared these costs to the fares perceived by the hospital from the French sickness fund (GHS). RESULTS: Thirty-six patients received a biological mesh and were treated by a total of 38 biological meshes. Of these, the implant was Protexa®, Permacol® and Strattice® in 66%, 29% and 5% of cases respectively. The hospitals incomes were 10,496±5562€ per stay. Meshes-related expenditures represented in average 28% of DRGs costs and 38% of GHS tariffs. The mean additional cost for biological meshes was 3793±2292 euros compared to the mean cost on implantable medical devices in the French DRGs. CONCLUSION: Given their currently restricted use, the hospital budget impact of biological meshes remains limited although the incremental cost per patient is substantial. Analytic costs data can be useful within the scope of decision-making related to DM not refunded by the French health system.

Conflicts of Interest in Medical Technology Markets: Evidence from Orthopedic Surgery.

Financial relationships between physicians and industry are vital to biomedical innovation yet create the potential for conflicts of interest in medical practice. I consider an inducement model of the role of financial relationships in health care markets, where consulting payments induce physicians to use more devices of the firms that sponsor them. To test the model, I exploit a policy shock, whereby government monitoring of payments to joint replacement surgeons resulted in declines of over 60% in both total payments and in the number of physicians receiving payments from 2007 to 2008. Using hospital discharge data from three states, I find that the loss of payments leads physicians to switch 7 percentage points of their device utilization from their sponsoring firms' devices to other firms' devices, an effect which is concentrated among surgeons with low switching costs. These results offer support for the inducement model. I also find evidence of an increase in medical productivity following the policy intervention, which suggests conditions under which regulation of financial relationships would be socially beneficial. Copyright © 2015 John Wiley & Sons, Ltd.

Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model. Final rule.

This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program, including the inclusion of new quality measures beginning with payment year (PY) 2020 and provides updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also implements statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also expands suppliers' appeal rights in the event of a breach of contract action taken by CMS, by revising the appeals regulation to extend the appeals process to all types of actions taken by CMS for a supplier's breach of contract, rather than limit an appeal for the termination of a competitive bidding contract. The rule also finalizes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from CBPs and for submitting bids and establishing single payment amounts under the CBPs for certain groupings of similar items with different features to address price inversions. Final changes also are made to the method for establishing bid limits for items under the DMEPOS CBPs. In addition, this rule summarizes comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule also summarizes comments received in response to a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.

Cost effective cosmetic prosthesis for lost digits.

Leprosy causes nerve damage which leads to repeated injuries or ulcers causing the loss or absorption of digits. The loss of digits is also common in traumatic injuries. Irrespective of the etiology, the loss of a finger has a considerable negative functional and psychological impact on an individual. In order to solve these problems, prostheses are provided to patients. This short report demonstrates the advantages of using liquid latex in making a low cost cosmetic prosthesis. The possibility of using latex material offers a practical alternative where silicone prosthesis is not affordable.