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.

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.

Medication, rehabilitation and health care consumption in adults with cerebral palsy: a population based study.

OBJECTIVE: To evaluate medication, rehabilitation and healthcare consumption in adults with CP as a function of Gross Motor Function Classification System (GMFCS) level. DESIGN: Questionnaire-based cross-sectional study. SETTING: Brittany, a French county. SUBJECTS: Adults with cerebral palsy. INTERVENTIONS: Questionnaires relating to drugs, orthotic devices, mobility aids, rehabilitation and medical input were sent to 435 members of a unique regional French network dedicated to adults with cerebral palsy. The questionnaire was completed by the participant or a helper if necessary. RESULTS: Of the 282 responders, 7.8% had a GMFCS level of I, 14.2% II, 17.7% III, 29.1% IV and 31.2% V. Participants consumed a large amount of healthcare. Almost three-quarters took orally administered drugs, of which antispastic and antiepileptic drugs were among the most frequent. Nearly all patients had at least one type of rehabilitation, 87.2% had physiotherapy, 78% used at least one mobility aid and 69.5% used at least one orthotic device. The frequency of numerous inputs increased with GMFCS level. Specificities were found for each GMFCS level, e.g. participants with GMFCS level IV and V had a high level of medical input and a greater use of trunk-supporting devices, antireflux and laxative. Profiles could be established based on GMFCS levels. CONCLUSIONS: Adults with cerebral palsy use a large amount of drugs, mobility aids, orthotic devices, rehabilitation and medical input. Healthcare is targeted at cerebral palsy-related issues. GMFCS is a determinant of healthcare consumption and thus a useful tool for clinical practice to target care appropriately.

Current Trends in the Management of Lateral Ankle Sprain in the United States.

OBJECTIVE: To characterize trends in the acute management (within 30 days) after lateral ankle sprain (LAS) in the United States. DESIGN: Descriptive epidemiology study. PATIENTS: Of note, 825 718 ankle sprain patients were identified; 96.2% were patients with LAS. Seven percent had an associated fracture and were excluded from the remaining analysis. SETTING: Primary and tertiary care settings. INTERVENTIONS: We queried a database of national health insurance records for 2007 to 2011 by ICD-9 codes for patients with LAS while excluding medial and syndesmotic sprains and any LAS with an associated foot or ankle fracture. MAIN OUTCOME MEASURES: The percentage of patients to receive specific diagnostic imaging, orthopedic devices, or physical therapy treatments within 30 days of the LAS diagnosis and the associated costs. RESULTS: Over two-thirds of patients with LAS without an associated fracture received radiographs, 9% received an ankle brace, 8.1% received a walking boot, 6.5% were splinted, and 4.8% were prescribed crutches. Only 6.8% received physical therapy within 30 days of their LAS diagnosis, 94.1% of which performed therapeutic exercise, 52.3% received manual therapy, and 50.2% received modalities. The annual cost associated with physician visits, diagnostic imaging, orthopedic devices, and physical therapy was 152 million USD, 81.5% was from physician evaluations, 7.9% from physical therapy, 7.2% from diagnostic imaging, and 3.4% from orthopedic devices. CONCLUSIONS: Most patients with LAS do not receive supervised rehabilitation. The small proportion of patients with LAS to receive physical therapy get rehabilitation prescribed in accordance with clinical practice guidelines. The majority (>80%) of the LAS financial burden is associated with physician evaluations.

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.

Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies. Final rule.

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.

Medicare program; End-Stage Renal Disease prospective payment system, quality incentive program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies. Final rule.

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.

Use of locally made off-loading techniques for diabetic plantar foot ulcer in Karachi, Pakistan.

The aim of this study was to evaluate the effectiveness of applying locally made pressure off-loading techniques on plantar foot ulcer in individuals with diabetes. This prospective study of 70 diabetic patients was conducted at the foot clinic of Baqai Institute of Diabetology & Endocrinology. Plantar foot ulcer, stages 1A and 2A according to the University of Texas classification, was treated by using three off-loading techniques: modified foot wear (sandal), modified plaster of Paris cast with plywood platform and Scotchcast boot. The outcome was assessed at either complete wound healing (defined as complete epithelialisation) or at 12 weeks, whichever came first. Of the 70 patients, 24 were in modified foot wear group, 23 in modified plaster of Paris cast and 23 in Scotchcast boot group. There was almost equal proportion of patients healed within 12 weeks period treated with these three off-loading techniques, i.e. 22 (95·7%) for modified foot wear group, 19 (95%) for modified plaster cast and 18 (94·7%) for Scotchcast boot group. No significant difference was observed in median healing time and cumulative wound survival at 12 weeks in the three off-loading techniques. Modified foot wear group was the most cost effective ($7) amongst the three off-loading techniques. It is concluded that in this cohort, no significant difference in healing time was observed in the three off-loading techniques, although modified foot wear (sandal) was found to be a more cost-effective treatment modality.

Medicare program; end-stage renal disease prospective payment system, quality incentive program, and durable medical equipment, prosthetics, orthotics, and supplies.

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.

Cost of treating sagittal synostosis in the first year of life.

BACKGROUND: Endoscopically assisted suturectomy (EAS) has been reported to reduce the morbidity and cost of treating sagittal synostosis when compared with traditional open cranial vault remodeling (CVR) procedures. Whereas the former claim is well substantiated and intuitive, the latter has not been validated by rigorous cost analysis. METHODS: Patient medical records and financial database reports were culled retrospectively to determine the total cost associated with both EAS and CVR during 1 year of care. Recorded cost data included physician and hospital services, orthotic equipment and fittings, and indirect patient cost. RESULTS: Ten patients treated with CVR were compared with 10 patients who underwent EAS. The CVR patients incurred greater costs in nearly all categories studied, including overall 1-year costs, physician services, hospital services, supplies/equipment, medications/intravenous fluids, and laboratory and blood bank services. Postoperative costs were greater in the EAS group, primarily because of the cost associated with orthotic services and indirect patient costs for travel and lost work. However, overall indirect patient costs for the whole year did not differ between the groups. One-year median costs were $55,121 for CVR and $23,377 for EAS. Early clinical results were similar for the 2 groups. CONCLUSIONS: Cranial vault remodeling was more costly in the first year of treatment than EAS, although indirect patient costs were similar. The favorable cost of EAS compared with CVR provides further justification to consider this procedure as first-line treatment of sagittal synostosis in young infants.

Medicare program; revisions to the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier safeguards. Final rule.

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.

Predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people.

BACKGROUND: Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls, there is little evidence as to whether foot-related intervention strategies can be successfully implemented. The aim of this study was to evaluate adherence rates, barriers to adherence, and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people. METHODS: The intervention group (n = 153, mean age 74.2 years) of a randomised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention: (i) foot orthoses, (ii) footwear advice and footwear cost subsidy, and (iii) a home-based foot and ankle exercise program. Adherence to each component and the barriers to adherence were documented, and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components. RESULTS: Adherence to the three components of the intervention was as follows: foot orthoses (69%), footwear (54%) and home-based exercise (72%). Discriminant function analyses identified that being younger was the best predictor of orthoses use, higher physical health status and lower fear of falling were independent predictors of footwear adherence, and higher physical health status was the best predictor of exercise adherence. The predictive accuracy of these models was only modest, with 62 to 71% of participants correctly classified. CONCLUSIONS: Adherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72%. People with better physical health, less fear of falling and a younger age exhibited greater adherence, suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12608000065392.

Medicare program; payment policies under the physician fee schedule, five-year review of work relative value units, clinical laboratory fee schedule: signature on requisition, and other revisions to part B for CY 2012. Final rule with comment period.

This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also addresses, implements or discusses certain statutory provisions including provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. In addition, this final rule with comment period discusses payments for Part B drugs; Clinical Laboratory Fee Schedule: Signature on Requisition; Physician Quality Reporting System; the Electronic Prescribing (eRx) Incentive Program; the Physician Resource-Use Feedback Program and the value modifier; productivity adjustment for ambulatory surgical center payment system and the ambulance, clinical laboratory, and durable medical equipment prosthetics orthotics and supplies (DMEPOS) fee schedules; and other Part B related issues.

[Survey of carbon fiber reinforced plastic orthoses and occupational and medical problems based on a questionnaire administered to companies involved in the manufacture of prosthetics and orthotics].

We surveyed carbon fiber reinforced plastic orthoses (carbon orthoses) and their associated occupational and medical problems based on a questionnaire sent to 310 companies which were members of the Japan Orthotics and Prosthetics Association. Of all the companies, 232 responded: 77 of the 232 companies dealt with ready-made carbon orthoses, 52 dealt with fabricated custom-made orthoses, and 155 did not dealt with carbon orthoses. Although the total number of custom-made carbon ortheses in Japan was 829/ 5 years, there was a difference by region, and one company fabricated only 12 (per 5 years) custom-made carbon orthoses on average. The advantages of the carbon orthosis were the fact that it was "light weight", "well-fitted", had a "good appearance", and "excellent durability", while the disadvantages were that it was "expensive", "high cost of production", of "black color", and required a "longer time for completion", and "higher fabrication techniques". From the standpoint of industrial medicine, "scattering of fine fragments of carbon fibers", "itching on the skin" and "health hazards" were indicated in companies that manufacture the orthosis. In order to make the carbon orthosis more popular, it is necessary to develop a new carbon material that is easier to fabricate at a lower cost, to improve the fabrication technique, and to resolve the occupational and medical problems.

Prioritizing solutions to incorporate Prosthetics and Orthotics services into Iranian health benefits package: Using an analytic hierarchy process.

INTRODUCTION: Health benefits package (HBP) is regarded as one of the main dimensions of health financing strategy. Even with increasing demands for prosthetics and orthotics (P&O) services to approximately 0.5% of the world's population, only 15% of vulnerable groups have the chance to make use of such benefits. Inadequate coverage of P&O services in the HBP is accordingly one of the leading reasons for this situation in many countries, including Iran. AIMS: The main objective of this study was to find and prioritize solutions in order to facilitate and promote P&O services in the Iranian HBP. STUDY DESIGN: A mixed-methods (qualitative-quantitative) research design was employed in this study. METHODS: This study was conducted in two phases. First, semi-structured interviews were undertaken to retrieve potential solutions. Then an analytic hierarchy process (AHP) reflecting on seven criteria of acceptability, effectiveness, time, cost, feasibility, burden of disease, and fairness was performed to prioritize them. RESULTS: In total, 26 individuals participated in semi-structured interviews and several policy solutions were proposed. Following the AHP, preventive interventions, infant-specific interventions, inpatient interventions, interventions until 6 years of age, and emergency interventions gained the highest priority to incorporate in the Iranian HBP. CONCLUSION: A number of policy solutions were explored and prioritized for P&O services in the Iranian HBP. Our findings provide a framework for decision- and policy-makers in Iran and other countries aiming to curb the financial burdens of P&O users, especially in vulnerable groups.

Use and Cost of Orthosis in Conservative Treatment of Acute Thoracolumbar Fractures: A Survey of European and North American Experts.

STUDY DESIGN: Survey study. OBJECTIVE: Assess practices and opinions of spine specialists from Europe and North America on orthosis use in adult patients with acute thoracolumbar (TL) fractures. Evaluate cost of the devices. SUMMARY OF BACKGROUND DATA: Although orthosis are traditionally used in conservative treatment of TL fractures, recent systematic reviews showed no benefit in patient's outcomes. METHODS: A search for contact authors with publications on spine fractures from all European and North American countries was performed. An online questionnaire was sent on demographic data, practice setting, mean number of fractures treated, use of orthosis upon choice for conservative treatment, and average orthosis cost. Data was analyzed based in world regions, economic rank of the country, and health expenditure. RESULTS: We received 130 answers, from 28 European and five North American countries. Most responders had more than 9 years of practice and worked at a public hospital. 6.2% did not prescribe a brace in any patient with acute TL fractures conservatively treated and 11.5% brace all patients. In a scale from 1 to 5, 21 considered that there is no/low benefit (1) and 14 that bracing is essential (5), with a mean of 3.18. Europeans use orthosis less commonly than North Americans (P < 0.05). Orthosis mean cost was $611.4 ±â€Š716.0, significantly higher in North America compared with Europe and in high income, when compared with upper middle income countries (both P < 0.05). Although hospital costs were not evaluated, orthosis is costlier when it involves admission of the patient (P < 0.05). An increase in orthosis cost associated with higher gross domestic product (GDP) per capita and higher health expenditure was found. CONCLUSION: More than 90% of spine specialists still use orthosis in conservative treatment of adult patients with acute TL fractures. Orthosis cost vary significantly between continents, and it is influenced by the country's economy.Level of Evidence: 4.

Medicare program; establishing additional Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier enrollment safeguards. Final rule.

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.

A scoping literature review of studies assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions.

Purpose: Approximately 1.5% of the world's population (∼100 million people) need a prosthesis/orthosis. The objective of the study was to establish an overview of the literature that has examined prosthetic and orthotic interventions with a view to inform policy development.Methods: Fourteen databases were searched from 1995-2015. Studies reporting primary research on the effectiveness or cost-effectiveness of prosthetic and orthotic interventions were examined. Metadata and information on study characteristics were extracted from the included studies.Results: The searches resulted in a total of 28,958 articles, a focus on studies with the words "randomized" OR "randomized" OR "cost" OR "economic" in their citation reduced this total to 2644. Research has predominantly been conducted in Australia, Canada, Germany, Netherlands, UK and USA. A total of 346 randomized controlled trials were identified, with only four randomized controlled trials examining prosthetic interventions. The majority of research examined lower limb orthoses in the adult population and used a wide range of outcome measures.Conclusions: While various international organizations have highlighted the value of providing prosthetic and orthotic services, both to the user and society as a whole, the availability of scientific research to inform policy is limited. Future structured evaluation of prosthetic and orthotic interventions/services is warranted to inform future policy developments.Implications for rehabilitationResearch into prosthetic and orthotic interventions has grown substantially in the last 20 years, with most of this research conducted in a small number of countries and focusing on the use of lower limb orthotics in adult populations.Research to date has utilized an extensive range of outcome measures, the development of agreed standardized sets of outcomes would allow comparison and combination of results in future research.This study highlights the need for further research in this area, especially studies which examine the cost-effectiveness of prosthetic and orthotic provision.