Researchers cited in LCD proposal release statement are ‘strongly opposed’ to proposed changes

A group of U.S. researchers recently signed off on a letter expressing their opposition to the use of their research in support of a proposed policy that would govern Medicare coverage of lower limb prostheses if enacted.

The letter to the HHS states that nine researchers cited in the Local Coverage Determination (LCD) for Lower Limb Prostheses proposal bibliography are “extremely concerned that the [the LCD] was not based at all on the current literature and science associated with the provision of prosthetic care.”

According to the letter, the researchers believe their work does not support any of the changes outlined in the LCD proposal and many of the works cited are not peer-reviewed, are not current or “are not true citations in accordance with referencing standards by recognized entities.”

In addition, the researchers stated the articles cited in the LCD proposal bibliography are meant to support the proposal but actually could be used to invalidate the changes.

The letter concludes: “The current standard of practice is fully supported by sound, (peer-reviewed) scientific evidence. The changes proposed are not consistent with the current standard of practice and not derived from consultation with any of the referenced authors. As CMS has used our works in the preparation of this ill-conceived proposal, we are led to question why we, as health care experts in this field, were not consulted. The proposed changes … in our expert opinion, would diminish both the quality and access to prosthetic care across our nation. We, as the experts cited in this document, wish to go on record as strongly opposing the draft [rule].”

The joint comment letter was signed by the following researchers: M. Jason Highsmith, PT, DPT, CP, FAAOP, associate professor, School of Physical Therapy & Rehabilitation Sciences, Morsani College of Medicine, University of South Florida and president, American Academy of Orthotists and Prosthetists; Steven A. Gard, PhD, executive director, Northwestern University Prosthetics-Orthotics Center; Susan Kapp, MEd, CPO, LPO, FAAOP, associate professor and director, University of Texas Southwestern School of Health Professions Prosthetics-Orthotics Program; Lisa U. Pascual, MD, clinical professor, Department of Orthopedic Surgery, University of California, San Francisco; Brian M. Kelly, DO, professor and medical director, Division of Orthotics and Prosthetics, and assistant program director, Residency Training Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems; Don Cummings, CP, LP, director of prosthetics, Texas Scottish Rite Hospital for Children; John W. Michael, MEd, CPO/L FISPO, FAAOP, assistant professor of Physical Medicine & Rehabilitation, Northwestern University, Feinberg School of Medicine and director, Northwestern University Prosthetics-Orthotics Center; Robert S. Gailey, Jr., PhD, PT, professor, Department of Physical Therapy, Miller School of Medicine, University of Miami; and Robert S. Kistenberg, MPH, CP, LP, FAAOP, author, “Outcome Measures in Lower Limb Prosthetics.”

The letter is available online at         


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