Economic Impact of O&P Interventions: Research and O&P Organizations Lead the Way

By Miki Fairley

As technology advances, physicians and O&P clinicians have an ever-widening array of options to provide their patients with optimal prosthetic or orthotic solutions. However, the challenge of obtaining adequate reimbursement from Medicare and private insurers for some devices is intensifying. Payers are demanding more hard data.

Clinically relevant research is the key to developing new, more effective patient care protocols and providing support and justification for reimbursement of selected interventions. The American Orthotic & Prosthetic Association (AOPA) and the American Academy of Orthotists and Prosthetists (the Academy) are aggressively pursuing initiatives to accomplish these goals.

The O&P EDGE looks at these initiatives and three relevant research studies.

WHAT'S BEING DONE

  AOPA PRIORITIZES RESEARCH

Over the past four years, AOPA has budgeted $2 million for research. "Research is AOPA's highest priority because it is key to the future of O&P and reimbursements," the organization states in its brochure, "Leading the Way in 2016." The statement continues, "Peer-reviewed, independent scientific data is needed to prove our treatments are appropriate and cost effective."

RAND Research Project

AOPA has commissioned RAND, a global nonprofit think tank, to perform a comprehensive, independent, validated study quantifying the value of prosthetic services. "The study goes beyond the typical healthcare expenditures to include costs and savings associated with employment, taxpayer status, and state and federal social assistance programs," according to AOPA.

RAND will expand the study's initial scope to include an economic analysis for four types of advanced transtibial and transfemoral prostheses, including dynamic response feet, microprocessor knees (MPKs), microprocessor-controlled ankle-foot systems, and powered ankle-foot systems, says AOPA Executive Director Tom Fise, JD. Based on its systematic review of the available scientific literature, and conditional on sufficient published evidence, RAND will examine the economic impact of providing patients advanced transtibial and transfemoral prostheses along several dimensions: osteoarthritis, falls, and obesity. RAND will also explore other impacts of fitting patients with advanced transfemoral and transtibial prostheses based on the published literature or expert consultations. The gathered information will be incorporated into a final report.

"In addition to the study and final report, it is expected that this joint effort will likely end up comprising three components: the study and final report, as well as a freestanding simulation model on value over a 15-year time frame, and a white paper outlining AOPA's vision and comprehensive value of prosthetics," Fise says. At the time of this writing, a briefing, and potentially a final report, is expected to be released in March. The members of the Prosthetics 2020 Technical Advisory Committee are serving as expert consultants and advisors for the study.

Dobson DaVanzo 2

A 2013 landmark study, "Retrospective Cohort Study of the Economic Value of Orthotic and Prosthetic Services Among Medicare Beneficiaries" by Dobson DaVanzo & Associates, Vienna, Virginia, and commissioned by AOPA and the Amputee Coalition, showed that total Medicare costs are lower or similar for patients who received O&P services compared to patients who need but do not receive these services.

A new Dobson DaVanzo study is under way to try to replicate and expand upon the earlier work, says Fise. Since Medicare now allows access to Part D drug data, the study will include an examination of the impact of these medication costs on people with amputations who do and do not receive prosthetic or orthotic interventions. An initial report is anticipated before the AOPA 2017 Policy Forum on May 24-25.

Prosthetic Patient Registry

The proposed National Prosthetic Registry (NPR) will collect data related to key aspects of limb loss starting with the amputation and extending to functional outcomes that the patient achieves with various prosthetic devices, according to AOPA. "A September 20, 2016, meeting with NIH NCMRR [National Institutes of Health National Center for Medical Rehabilitation Research] indicated the possibility of NIH support in advancing the effort, and Dr. Kenton Kaufman has received a request for a complete proposal submission to the DoD [U.S. Department of Defense] outcomes grant project for potential funding," Fise adds. At the time of this writing, Level II pilot data has been collected from Scheck and Siress, Hanger Clinic, Wright and Filippis, Baker Orthotics & Prosthetics, Dankmeyer, and Prosthetic & Orthotic Care, demonstrating that information is accessible from prosthetists, Fise notes.


  ACADEMY IDENTIFIES KEY RESEARCH AREAS

Since 2015, the Academy has been undergoing an extensive process to identify the areas of O&P research that, with funding, could create "an unprecedented standard of care" as well as help practitioners increase insurance reimbursements, according to a November 2016 Academy news release. The Academy is investing more than $210,000 in research initiatives, its largest direct funding to date.

SSC Examines Body-powered Versus Myoelectric Prostheses

As its first initiative, the Academy convened its 12th State-of-the-Science Conference (SSC) September 16-17, 2016, in Orlando, Florida, on "Body Powered Versus Myoelectric Upper Extremity Prostheses," co-chaired by M. Jason Highsmith, PT, DPT, PhD, CP, FAAOP, and Phil Stevens, MEd, CPO, FAAOP.

Before the conference, the Academy commissioned an evidence report, "Differences in Myoelectric and Body- Powered Upper-Limb Prostheses: Systematic Literature Review," co-authored by Stephanie Carey, PhD; Derek Lura, PhD; and Highsmith and published in the Journal of Rehabilitation Research & Development, Vol. 52, No. 3, 2015 (www.ncbi.nlm.nih.gov/pubmed/26230500).

According to the evidence note, "Body-powered prostheses have been shown to have advantages in durability, training time, frequency of adjustment, maintenance, and feedback; however, they could still benefit from improvements of control. Myoelectric prostheses have been shown to improve cosmesis and phantom-limb pain and are more accepted for light-intensity work. Currently, evidence is insufficient to conclude that either system provides a significant general advantage.... There is a lack of empirical evidence regarding functional differences in upper-limb prostheses."

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Conference proceedings of the two-day meeting will be published, says Leigh Davis, MSPO, CPO, FAAOP, Academy vice president and Research Council chair. Participants wrote papers on their specialties for presentation and discussion at the conference and are now editing them for final submission to the SSC co-chairs.

Research Forges Ahead

"Last year we funded five scoping reviews-shorter reviews intended to see what's out there in terms of the research," Davis says. The topics were: "Outcome Measures for Persons Post- Stroke Who Use Orthoses," "Interface Mechanics in Prosthetic Socket Technology," "Cost, Efficacy for Transtibial Interventions," "Prosthetic Suspension," and "Metabolic Expenditure on Transtibial Prosthetic Users." Results of these scoping reviews led to funding two larger systematic reviews and an additional SSC, Davis added. The systematic reviews will explore "Outcome Measures for Persons Post-Stroke Who Use Orthoses" and "The Effects of Prosthetic Foot- Ankle Mechanisms on Metabolic Energy Expenditure in People with Transtibial Limb Loss or Deficiency."

SSC to Explore Transtibial Prosthetics Economics

The Academy's 13th SSC will focus on "Economics of Transtibial Prostheses."

The conference will likely be held in May, Davis says, although at the time of this writing, the date and location details were still being planned.

"We will be continuing the process of scoping the literature and identifying funding priorities on a regular basis," she adds. "In 2017, we will be funding a scoping review on "Lower- Extremity Prostheses Users and Falls Risk Management."

RESEARCH EVALUATES THE ECONOMIC IMPACT OF PROSTHETIC CARE

Three recent, relevant research studies assess economic effects of lower-limb prosthetic interventions and help point the way to further research.

Scoping Review Explores Economics of Prosthetic Interventions

A 2016 review report, "Economic Evaluations of Interventions for Transtibial Amputees: A Scoping Review of Comparative Studies" (Technology and Innovation, 18 (2-3): 85-98), aimed to determine if sufficient evidence exists to conduct a formal systematic review or meta-analysis in any prosthetic intervention areas and to determine if evidence statements could be synthesized relative to economic evaluation of prosthetic interventions provided to patients with transtibial amputations. (Editor's note: To access the review, visit www.oandp.com/link/348.)

After a literature search and a two-stage screening process, six articles remained that met the eligibility criteria. The studies included 704 patients: 460 were undergoing limb salvage and 244 had transtibial amputations due to mixed etiologies.

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Economic outcomes included costs of prosthetic fabrication, prosthetic maintenance, prosthetic provision, amputation or limb reconstruction surgeries, and total care. To assess economic evaluation quality, two reviewers utilized the Quality of Health Economic Studies (QHES) instrument and averaged per-item scores. Clinical outcome measures reported in the reviewed publications included duration of care, perceived function, prosthetic satisfaction, clinical gait outcomes, time to prosthetic delivery, and number of visits.

The five empirical evidence statements (EESs) were divided into three topical areas: care models, prosthetic treatment, and prosthetic sockets. The Academy's SSC Evidence Report Guidelines were used in assigning confidence to the EESs. Four EESs, with only one supporting study each, had an insufficient confidence level due to limited evidence. One evidence statement (EES 4), with two supporting studies, rated a moderate confidence level.


EES 1, CARE MODEL TOPICAL AREA

In socialized healthcare systems, patients with unilateral transtibial amputations may experience similar clinical outcomes from the interim to definitive prosthetic stages of rehabilitation with lower average per-patient labor costs and higher satisfaction when managed in a public-sector care model compared with a private-sector care model.

The supporting study has high internal and external validity and QHES-rated as fair quality, thus providing high clinical outcomes confidence and moderate economic analysis confidence. However, only Australia's socialized medical model is used.


EES 2, PROSTHETIC TREATMENT TOPICAL AREA

Patients having experienced lower-limb trauma requiring limb salvage or transtibial amputations will likely experience similar hospitalization duration regardless of the choice of surgical procedure. However, the two-year costs, on average, will be approximately 6 percent higher for transtibial amputations versus limb salvage. In some situations, the limb trauma and type of limb salvage procedure can necessitate up to 5 percent higher costs compared with transtibial amputations.

This EES is supported by a study with low internal and high external validity and high quality as rated by the QHES, thus providing moderate clinical outcomes confidence and high economic analysis confidence. However, the study has internal disagreement regarding costs relative to specific amputation levels and certain types of limb salvage procedures.


EES 3, PROSTHETIC TREATMENT TOPICAL AREA

Patients with Charcot foot arthropathy and multiple comorbidities will likely experience up to 13 percent increased one-year costs (including hospitalization, device provision, and therapy) if limb salvage is selected as opposed to transtibial amputation.

The supporting study has low internal and high external validity and fair quality as rated by the QHES. Clinical outcomes were not reported.


EES 4, PROSTHETIC SOCKETS TOPICAL AREA

Provision of patellar tendon bearing (PTB) sockets for patients with transtibial amputations costs 40 percent less than total contact socket alternatives; however, PTB sockets require up to three times longer to achieve a proper fit, with no clinical performance differences between the alternatives.

The two supporting studies have moderate internal validity and high external validity and are QHES-rated as fair quality, thus providing moderate clinical outcomes confidence and fair economic analysis confidence. However, the authors note that a recent systematic review suggests that use of gel-lined sockets, as opposed to traditional PTB sockets, results in clinical benefits, including decreased dependence on walking aids, improved suspension options, improved load distribution, decreased pain, and increased comfort. Thus, improvement in clinical outcomes may result in greater value for users.


EES 5, PROSTHETIC SOCKETS TOPICAL AREA

Compared with traditional plaster casting fabrication, the direct manufacturing method of providing prosthetic sockets for patients with transtibial amputations [results in] 32 percent higher provision costs, but [prosthetic sockets] are delivered to patients up to 58 percent faster and in fewer visits.

The supporting study has moderate internal validity and high external validity and is QHES-rated as fair quality, thus providing moderate clinical outcomes confidence and fair economic analysis confidence. However, no data was found that supported widespread adoption of direct manufacturing techniques for transtibial sockets.


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Conclusion: Scoping Review

Current comparative economic literature about transtibial prostheses is insufficient for further review, conclusion, and policy guidance, and further and more sophisticated economic analyses are needed, the review concludes. "Guidance from the profession may be useful in devising a strategy for how to assure economic analyses are a routine element of prosthetic science in the future."

Literature Review Examines C-Leg Safety, Energy Efficiency, Cost Efficacy

A structured literature review conducted in 2010, "Safety, Energy Efficiency, and Cost Efficacy of the C-Leg for Transfemoral Amputees: A Review of the Literature" (Prosthetics and Orthotics International, 34 (4):362-77), provided a recommendation grade for patient safety, gait energy efficiency, and cost effectiveness of the Ottobock C-Leg MPK. (Editor's note: To access the study, visit www.oandp.com/link/349.)

After a database search, studies were screened and sorted for methodologic quality and bias risk, resulting in 18 studies that met inclusion criteria for the review; seven studies were pertinent for safety, eight for energy efficiency, and three for cost effectiveness.

"Regarding safety, available evidence supports a grade B recommendation that...C-Leg users will experience a reduction in stumble and fall events and have improved balance." Although a grade D recommendation supports using the C-Leg to improve energy efficiency, "research has shown that amputees spontaneously increase their physical activity in the free-living environment when using the C-Leg compared to a non-microprocessor-controlled knee," the authors point out. "So, energy efficiency may not be of primary relevance."

Cost Effectiveness

The studies received a grade B recommendation that provision of a C-Leg is cost effective from a societal perspective and provides a positive quality-adjusted life year (QALY) gain. A QALY is the survival or treatment time corrected by the patient's quality of life (QOL), explains a study synopsis on the Ottobock website. QOL is measured by means of validated questionnaires; results can be converted into a utility index. To calculate QALY, the lifespan of the product is multiplied with the utility index. A cost-utility analysis based on the incremental cost for the difference of one QALY (money required to produce one additional QALY) facilitates the comparison of different treatments for different diseases or disabilities.

The C-Leg falls well within standard cost-effectiveness thresholds, according to one study. Given the negative societal incremental cost-utility ratios and the higher cost of the C-Leg, cost savings in these studies must be accomplished via higher productivity loss, patient/family caretaker costs, and household assistance costs associated with non-electronic prostheses, the authors note. One study reports 40 percent higher productivity losses for the mechanical knee group; another study found higher housekeeping assistance loss with the non-electronic group along with lower productivity loss cost for the C-Leg group. The review recommends further research on differences in duration of time to employment and housekeeping assistance requirements during rehabilitation. Since these studies were based on the respective healthcare systems of three European countries, the review recommends further cost-effectiveness studies be undertaken in other countries.

Research Shows Similar Cost, Better Outcomes for Prosthetic Patients

A 2016 study, "Economic Value of Prosthetic Services Among Medicare Beneficiaries: A Claims-Based Retrospective Cohort Study" (Military Medicine, 181 (2 Suppl):18-24), was based on prosthetics-related research findings that were included in the 2013 Dobson DaVanzo study previously mentioned. The new study found that patients with amputations who received lower-limb prostheses had comparable Medicare episode payments ($6,099 per member per month for the study group and $6,015 per member per month for the comparison group) and better outcomes than patients who did not receive prostheses. Patients receiving prostheses were more likely to receive extensive outpatient therapy; physical therapy is associated with fewer hospitalizations and emergency room visits, and less facility-based care, essentially offsetting prosthetic cost over a 12-month period. (Editor's note: To access the study, visit www.oandp.com/link/350.)

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Research also indicates that prosthetic use can lead to societal gains that include returning to work and reduced reliance on social services. The cost of the services is nearly, if not completely, amortized through reduced acute care hospitalizations and facility-based care.

Although it appears much remains to be done to solidly establish the cost effectiveness and value of O&P interventions, these research initiatives and research studies are pointing the way and setting the pace.

Miki Fairley is a freelance writer based in southwest Colorado. She can be contacted at .