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
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.”
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.)
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 .