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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.

Background: A corticosteroid-eluting sinus implant was recently approved by the FDA as a drug to treat adult patients with nasal polyps who have undergone previous endoscopic sinus surgery (ESS) of the ethmoid sinuses. ESS is performed in an operating room under general anesthesia, whereby diseased tissue and bone are removed to provide improved drainage. ESS typically involves dissection of 1 or more of the 4 paired sinus cavities (maxillary, ethmoid, sphenoid, or frontal). The implant, containing 1,350 mcg of mometasone furoate, is inserted by a physician in an office setting and offers controlled localized release of corticosteroid to the polypoid sinus tissue. The implant has demonstrated significant improvements in clinical testing; however, little research has been conducted on its economic impact., Objective: To evaluate and quantify the budget impact to a commercial payer of using this implant instead of ESS in patients with nasal polyps after a previous ESS. Since essentially all patients with recurrent nasal polyps after ESS are patients with chronic sinusitis (CS) diagnosis, this study also identified patients with CS with nasal polyposis (CSwNP) for consistency with the patient population studied in clinical trials evaluating the implant., Methods: A budget impact analysis was conducted from a U.S. commercial payer perspective over a 1-year time horizon with patients who received the implant or revision ESS. Primary outcomes of interest were annual total and per-member per-month (PMPM) direct health care costs. Costs were estimated using a decision analysis model, assuming 50% implant utilization as an alternative to revision ESS in eligible patients, with other levels (25%, 75%) also considered. The model utilized the results of a recently published analysis of 86,052 patients in the Blue Health Intelligence database, results from published clinical trials evaluating the implant, a literature review, and published Medicare national payment amounts., Results: A commercial health plan with 1 million members could anticipate 1,000 CSwNP patients as candidates for receiving the implant or revision ESS. Estimated direct treatment costs for refractory CSwNP using only revision ESS are $11.03 million ($0.92 PMPM). If the implant replaced surgery in 50% of cases and if 63% those patients received a second treatment with the implant during the year, the estimated total cost savings would be $2.56 million ($0.21 PMPM). Cost savings associated with using the implant changed to $0.11 PMPM and $0.32 PMPM with implant adoption of 25% and 75%, respectively., Conclusions: In a large commercially insured U.S. population, annual revision ESS costs are substantial. Using the implant instead of revision ESS could result in considerable cost savings for payers at various levels of adoption., Disclosures: This study was sponsored by Intersect ENT, which was involved in study design and manuscript review. Ernst and Imhoff are employed by CTI Clinical Trial and Consulting Services, which contracted with Intersect ENT to conduct this study. Ernst and Imhoff also report other financial support from Intersect ENT during the conduct of the study. DeConde reports personal fees from Intersect ENT during the conduct of the study, as well as personal fees from Optinose, Stryker Endoscopy, and Olympus, outside the submitted work. Manes reports grants from Intersect ENT during the conduct of the study, as well as grants from Optinose and Sanofi outside the submitted work.

Medical devices are estimated to account for 6 percent of health expenditures in the US and 7 percent in European Union (EU) countries. Cardiac implants are a large segment of the market, but little is known about their prices. Using 2006-14 data from a large hospital panel survey, this article provides a systematic comparison of prices of cardiac implants between the US and four EU countries. The data reveal that prices were two to six times higher in the US than in Germany, where cardiac implants were generally the cheapest. Prices also varied between EU countries. Prices of coronary stents and pacemakers were higher in France and Italy than in the UK, where prices were similar to those in Germany. The data also confirmed findings of prior studies that found significant price variation between hospitals within a given country. This study found that within- and between-country variations were similar in magnitude. While these findings can help assess whether technology-related policies effectively control the prices of cardiac devices, future research is necessary to establish a causal relationship between prices and several possible explanatory factors and help policy makers understand which mechanisms are available to control device prices.

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.

Objective: Health care costs are increasing in medicine and in orthopedics. Device choice in orthopedic cases can impact the cost of the procedure and thus result in cost savings. This study aims to determine whether orthopedic attendings and residents accurately estimate device costs they are implanting in trauma cases and whether costs would influence their surgical device selection., Design: Using nationally published average cost data for 13 implants, a survey was distributed at 6 US academic centers. Respondents were asked to select the correct cost from cost ranges. They also answered yes/no questions about their choices regarding published research outcomes for specific fractures. Residents' answers were compared with faculty answers using t tests for each cost estimate question, and chi-square tests for yes/no questions and frequencies., Results: A total of 51 faculty members and 76 residents responded. Attending estimates were closer to the actual cost for most devices. The average total error in cost estimate for all 13 implants was $11,288.36 for residents (35.6% difference) and $10,208.33 for faculty members (32.2% difference). Significantly more faculty members estimated costs within 10% versus residents. When asked if the literature showed differences in outcome when using different implants to treat 4 common fractures, most answered these questions correctly. Further, 71.1% of residents said their choice of implant would change if costs affected physician reimbursements versus 58% for faculty members., Conclusions: Our data indicate orthopedic physicians are not aware of true implant costs and nearly half of attendings would not consider cost as a factor in deciding between equivalent implants, even if this affected their reimbursement. Most notably, participants showed a poor ability to closely estimate the cost of more expensive implants (actual device cost greater than $2000). Our results suggest that medical cost containment should be stressed to the next generation of surgeons., (Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

This final rule establishes a prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization. This rule defines unnecessary utilization and creates a new requirement that claims for certain DMEPOS items must have an associated provisional affirmed prior authorization decision as a condition of payment. This rule also adds the review contractor's decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.

The demand for spinal surgery and its costs have both risen over the past decade. In 2008 the aggregate hospital bill for surgical care of all spinal procedures was reported to be $33.9 billion. One key driver of rising costs is spinal implants. In 2011 our institution implemented a cost containment programme for spinal implants which was designed to reduce the prices of individual spinal implants and to reduce the inter-surgeon variation in implant costs. Between February 2012 and January 2013, our spinal surgeons performed 1493 spinal procedures using implants from eight different vendors. By applying market analysis and implant cost data from the previous year, we established references prices for each individual type of spinal implant, regardless of vendor, who were required to meet these unit prices. We found that despite the complexity of spinal surgery and the initial reluctance of vendors to reduce prices, significant savings were made to the medical centre., (©2015 The British Editorial Society of Bone & Joint Surgery.)

This final rule will update and make revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2015. This rule also finalizes requirements for the ESRD quality incentive program (QIP), including for payment years (PYs) 2017 and 2018. This rule will also make a technical correction to remove outdated terms and definitions. In addition, this final rule sets forth the methodology for adjusting Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment amounts using information from the Medicare DMEPOS Competitive Bidding Program (CBP); makes alternative payment rules for certain DME under the Medicare DMEPOS CBP; clarifies the statutory Medicare hearing aid coverage exclusion and specifies devices not subject to the hearing aid exclusion; will not update the definition of minimal self-adjustment; clarifies the Change of Ownership (CHOW) and provides for an exception to the current requirements; revises the appeal provisions for termination of a CBP contract, including the beneficiary notification requirement under the Medicare DMEPOS CBP, and makes a technical change to the regulation related to the conditions for awarding contracts for furnishing infusion drugs under the Medicare DMEPOS CBP.

Orthopedic procedures represent a large expense to the Medicare program, and costs of implantable medical devices account for a large proportion of those procedures' costs. Physicians have been encouraged to consider cost in the selection of devices, but several factors make acquiring cost information difficult. To assess physicians' levels of knowledge about costs, we asked orthopedic attending physicians and residents at seven academic medical centers to estimate the costs of thirteen commonly used orthopedic devices between December 2012 and March 2013. The actual cost of each device was determined at each institution; estimates within 20 percent of the actual cost were considered correct. Among the 503 physicians who completed our survey, attending physicians correctly estimated the cost of the device 21 percent of the time, and residents did so 17 percent of the time. Thirty-six percent of physicians and 75 percent of residents rated their knowledge of device costs "below average" or "poor." However, more than 80 percent of all respondents indicated that cost should be "moderately," "very," or "extremely" important in the device selection process. Surgeons need increased access to information on the relative prices of devices and should be incentivized to participate in cost containment efforts.

This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2014. This rule also sets forth requirements for the ESRD quality incentive program (QIP), including for payment year (PY) 2016 and beyond. In addition, this rule clarifies the grandfathering provision related to the 3-year minimum lifetime requirement (MLR) for Durable Medical Equipment (DME), and provides clarification of the definition of routinely purchased DME. This rule also implements budget-neutral fee schedules for splints and casts, and intraocular lenses (IOLs) inserted in a physician's office. Finally, this rule makes a few technical amendments and corrections to existing regulations related to payment for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items and services.

This final rule removes the definition of "direct solicitation'' and allows DMEPOS suppliers, including DMEPOS competitive bidding program contract suppliers, to contract with licensed agents to provide DMEPOS supplies, unless prohibited by State law. It also removes the requirement for compliance with local zoning laws and modifies certain State licensure requirement exceptions.

Background: There is ongoing concern over potential conflict of interest inherent in physician relationships with industry. However, there are limited empirical data detailing the prevalence and magnitude of these relationships. Our objective was to use data made available by a US Department of Justice (DOJ) lawsuit to describe the extent of orthopedic surgeons' financial relationships with implant manufacturers., Methods: We used data made available by the 2007 DOJ settlement with 5 major joint implant manufacturers to detail the number of orthopedic surgeons receiving payments, the size of these payments, the aggregate dollar amount, and the proportion going to academically affiliated orthopedic surgeons between 2007 and 2010., Results: In 2007, 1041 payments totaling in excess of $198 million were made to 939 orthopedic surgeons. In 2008, following the DOJ settlement, the implant makers made 568 payments totaling more than $228 million to 526 orthopedic surgeons (which included $109 million in one-time royalty buyouts by a single firm). The proportion of surgeons receiving payments who had academic affiliations rose from 39.4% in 2007 to 44.9% in 2008. Similar patterns were observed in 2009 and 2010 for 3 firms that continued to disclose by choice. We also noted substantial variation across firms in the details provided in the disclosed data., Conclusions: The impact of the DOJ settlement in the short term appears complex, with an increase in payments, a decline in the number of consultants, and an increase in the proportion of consultants drawn from academia. There is a need for clearer specific requirements for disclosure to allow for meaningful long-term analyses to be performed.

This final rule will clarify, expand, and add to the existing enrollment requirements that Durable Medical Equipment and Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers must meet to establish and maintain billing privileges in the Medicare program.

Veterans injured in theaters of combat operations are eligible for benefits, including medical care and compensation. This article describes veterans with service-connected disability for major lower- and/or upper-limb loss resulting from combat-field-associated injuries sustained in the Vietnam war, Operation Desert Shield/Operation Desert Storm, and Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF). Using the Department of Veterans Affairs (VA) Compensation and Pension Mini-Master file, we identified 2,690 veterans who in August 2007 received compensation for loss of one or more limbs. More than 97% sustained their injuries in Vietnam; most were young men who served in the U.S. Army or Marine Corps. All but 5% had at least 50% combined service-connected disability and nearly half had a 100% rating. In addition to limb loss, one of the most prevalent compensable conditions was posttraumatic stress disorder, present in 46% of OIF/OEF and 20% of Vietnam veterans. Of these veterans, 82% visited VA outpatient clinics in 2007, although only 4% were hospitalized. A special obligation exists to those who have sustained serious injuries related to combat; this responsibility extends for the life of the servicemember and beyond to his or her spouse and dependents.

This interim final rule with comment period implements certain provisions of section 154 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) related to the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition Program. Specifically, this rule: Implements certain MIPPA provisions that delay implementation of Round 1 of the program; requires CMS to conduct a second Round 1 competition (the "Round 1 rebid") in 2009; and mandates certain changes for both the Round 1 rebid and subsequent rounds of the program, including a process for providing feedback to suppliers regarding missing financial documentation and requiring contractors to disclose to CMS information regarding subcontracting relationships.

This document adopts a final rule amending the Department of Veterans Affairs (VA) medical regulations for the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) to expand benefits by covering any non-dental prostheses determined medically necessary for the treatment of certain medical conditions and by removing the exclusion from coverage of enuretic (bed-wetting) devices. In addition, this final rule makes changes in delegations of authority, technical changes, and nonsubstantive changes for purposes of clarity in VA's regulations governing CHAMPVA.

Study Design: This is a retrospective, independent study comparing 2 groups of patients treated surgically for discogenic low back pain associated with degenerative disc disease (DDD) in the lumbosacral spine., Objective: To compare the surgical and hospitalization charges associated with 1- and 2-level lumbar total disc replacement and circumferential lumbar fusion., Summary of Background Data: Reported series of lumbar total disc replacement have been favorable. However, economic aspects of lumbar total disc replacement (TDR) have not been published or studied. This information is important considering the recent widespread utilization of new technologies. Recent studies have demonstrated comparable short-term clinical results between TDR and lumbar fusion recipients. Relative charges may be another important indicator of the most appropriate procedure. We report a hospital charge-analysis comparing ProDisc lumbar disc replacement with circumferential fusion for discogenic low back pain., Methods: In a cohort of 53 prospectively selected patients with severe, disabling back pain and lumbar disc degeneration, 36 received Synthes ProDisc TDR and 17 underwent circumferential fusion for 1- and 2-level degenerative disc disease between L3 and S1. Randomization was performed using a 2-to-1 ratio of ProDisc recipients to control spinal fusion recipients. Charge comparisons, including operating room charges, inpatient hospital charges, and implant charges, were made from hospital records using inflation-corrected 2006 U.S. dollars. Operating room times, estimated blood loss, and length of stay were obtained from hospital records as well. Surgeon and anesthesiologist fees were, for the purposes of comparison, based on Medicare reimbursement rates. Statistical analysis was performed using a 2-tailed Student t test., Results: For patients with 1-level disease, significant differences were noted between the TDR and fusion control group. The mean total charge for the TDR group was $35,592 versus $46,280 for the fusion group (P = 0.0018). Operating room charges were $12,000 and $18,950, respectively, for the TDR and fusion groups (P < 0.05). Implant charges averaged $13,990 for the fusion group, which is slightly higher than the $13,800 for the ProDisc (P = 0.9). Estimated blood loss averaged 794 mL in the fusion group versus 412 mL in the TDR group (P = 0.0058). Mean OR minutes averaged 344 minutes for the fusion group and 185 minutes for the TDR (P < 0.05) Mean length of stay was 4.78 days for fusion versus 4.32 days for TDR (P = 0.394). For patients with 2-level disease, charges were similar between the TDR and fusion groups. The mean total charge for the 2-level TDR group was $55,524 versus $56,823 for the fusion group (P = 0.55). Operating room charges were $15,340 and $20,560, respectively, for the TDR and fusion groups (P = 0.0003). Surgeon fees and anesthesiologist charges based on Medicare reimbursement rates were $5857 and $525 for the fusion group, respectively, versus $2826 and $331 for the TDR group (P < 0.05 for each). Implant charges were significantly lower for the fusion group (mean, $18,460) than those for 2-level Synthes ProDisc ($27,600) (P < 0.05). Operative time averaged 387 minutes for fusion versus 242 minutes for TDR (P < 0.0001). EBL and length of stay were similar., Conclusion: Patients undergoing 1- and 2-level ProDisc total disc replacement spent significantly less time in the OR and had less EBL than controls. Charges were significantly lower for TDR compared with circumferential fusions in the 1-level patient group, while charges were similar in the 2-level group.

This final rule establishes competitive bidding programs for certain Medicare Part B covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act. These competitive bidding programs, which will be phased in over several years, utilize bids submitted by DMEPOS suppliers to establish applicable payment amounts under Medicare Part B.

Orthopedic hip and knee implant costs have risen 132 percent from 1991 to 2004, whereas reimbursements have only risen 16 percent. This increase is large, but the problem would not be as significant if reimbursement rates could compete with these increases. Medicare reimbursement has decreased 35 percent over the same time period. Health care professionals may not be able to change reimbursement methodologies, but we can offer cost-saving ideas to help balance out the equation. Although the primary purpose of demand matching is to improve implant selection based upon patient needs, it can also be used to help contain costs.

This final rule will update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2007 (for discharges occurring on or after October 1, 2006 and on or before September 30, 2007) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). We are revising existing policies regarding the prospective payment system within the authority granted under section 1886(j) of the Act. In addition, we are revising the current regulation text to reflect the changes enacted under section 5005 of the Deficit Reduction Act of 2005. This final rule will also establish certain requirements related to competitive acquisition for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) and establish accreditation of DMEPOS suppliers as required under section 302 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

After more than 25 years of clinical experience, the BAHA (bone-anchored hearing aid) system is a well-established treatment for hearing-impaired patients with conductive or mixed hearing loss. Owing to its success, the use of the BAHA system has spread and the indications for application have gradually become broader. New indications, as well as clinical applications, were discussed during scientific roundtable meetings in 2004 by experts in the field, and the outcomes of these discussions are presented in the form of statements. The issues that were discussed concerned BAHA surgery, the fitting range of the BAHA system, the BAHA system compared to conventional devices, bilateral application, the BAHA system in children, the BAHA system in patients with single-sided deafness, and, finally, the BAHA system in patients with unilateral conductive hearing loss.