Nine U.S. researchers sent a joint letter to the U.S. Department of Health and Human Services (HHS) that said they are “extremely concerned that the [proposed Medicare rule to reduce care for amputees] was not based at all on the current literature and science associated with the provision of prosthetic care.” The nine researchers are authors of papers cited by Medicare as supportive of its planned move, but the letter writers say that their work cannot be used to justify the rule change.
The researchers say their letter disavowing the use of their research is important because the Medicare rule change to restrict care for individuals with amputations can only be made if it is justified by the best available scientific findings. The comment period for the controversial rule to reduce reimbursements for Medicare beneficiaries with amputations ended August 31. The draft Medicare Local Coverage Determination (LCD) for Lower Limb Prostheses has drawn widespread attention since it could trigger comparable changes at the U.S. Department of Veterans Affairs (VA) and with private payers. (Editor’s note: It has been reported elsewhere that the VA will also oppose this proposal, calling for it to be rescinded.)
In the joint letter, the researchers stated: “It has recently come to light that the bibliography that was associated with the decision-making process for this draft [rule] included papers that we had authored. We would like to go on record as stating that the works referenced do not support any of the changes outlined in the…proposal. In addition, many of the citations in the…bibliography are not peer reviewed, are not current, or are not true citations in accordance with referencing standards by recognized entities. We are extremely concerned that the [draft rule] was not based at all on the current literature and science associated with the provision of prosthetic care.”
The researchers continued: “The articles referenced…claimed to support the [draft rule] actually have no bearing on any of the policy changes…. In fact, many of the citations could be used to refute the proposed changes. Further, these selected references do not support the significantly diminished quality of care that beneficiaries would receive if the proposed changes were implemented. It is also clear that some of the articles referenced in the bibliography are not accessible for evaluation and comment, calling into greater question the quality of the science behind [the] proposed decision making when drafting the [rule].”
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 [the Centers for Medicare & Medicaid Services] 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 M. Jason Highsmith, PT, DPT, PhD, CP, FAAOP, associate professor, School of Physical Therapy & Rehabilitation Sciences, Morsani College of Medicine, University of South Florida, and president of the American Academy of Orthotists and Prosthetists; Steven A. Gard, PhD, executive director of Northwestern University Prosthetics-Orthotics Center (NUPOC); Susan Kapp, MEd, CPO/L, associate professor and director, University of Texas Southwestern, School of Health Professions, Prosthetics-Orthotics program; Lisa U. Pascual, MD, clinical professor, Department of Orthopaedic Surgery, University of California, San Francisco; Brian M. Kelly, DO, associate 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/L, FAAOP, director of prosthetics, Texas Scottish Rite Hospital for Children, Dallas; John W. Michael, MEd, CPO/L, FAAOP, FISPO, assistant professor of Physical Medicine and Rehabilitation, Northwestern University, Feinberg School of Medicine, and director of NUPOC; Robert S. Gailey, Jr., PhD, PT, professor, Department of Physical Therapy, Miller School of Medicine, University of Miami; and Robert S. Kistenberg, MPH, CP/L, FAAOP, author of the “Outcome Measures in Lower Limb Prosthetics” online education course.