The O&P Alliance met with the Centers for Medicare & Medicaid Services (CMS) staff on February 26 in Baltimore to discuss the Draft Local Coverage Determination (LCD) for Lower Limb Prostheses. CMS representatives included Acting Principal Deputy Administrator/Chief Medical Officer Patrick Conway, MD, MSc; Kate Goodrich, MD, director of the Center for Clinical Standards & Quality; and Susan Miller, MD, who is responsible for the planned Lower Limb Prostheses Interagency Workgroup. During the meeting, the O&P Alliance was informed that the workgroup is expected to generate a consensus statement within about one year. The participants in the workgroup have been chosen, but their names will not be announced until the consensus statement is released.
According to the American Orthotic & Prosthetic Association (AOPA), whose executive director, Thomas Fise, JD, participated in the meeting, Miller said that the consensus statement is not directly about the LCD, but about best practices in the care of Medicare beneficiaries who have amputations. A question was raised about whether the public would be allowed to see the comments on the LCD, and CMS responded that the information may be made available to the workgroup, but not to the public. While CMS officials said they would take suitable input, especially new scientific articles, there are not means by which public/stakeholder input from nongovernment individuals could be incorporated into the workgroup until after release of the consensus document.
After a discussion about the lack of transparency of this proposed approach, CMS officials said opening the process would likely necessitate shifting to a Federal Advisory Committee process, thus delaying the LCD process. The group also discussed the continued presence of the draft LCD on the CMS and Durable Medical Equipment Medicare Administrative Contractors’ websites, to which CMS responded that it is an essential part of the record, and that it would be highly unusual to have it removed from the websites. The Alliance pointed out that since none of the thousands of submitted comments were available to the public, the draft LCD is the only document that was deemed of sufficient critical importance to be available for viewing.
Other meeting topics included the reduction in Medicare spending for prosthetic devices in the years 2010-2014 and changes in spending on more advanced prostheses, as well as other data related to the care of those with amputations. AOPA, in its communications with legislators, has encouraged consideration for congressional oversight and potential clarification to assure that the U.S. Department of Health and Human Services statutes and rules clearly allow CMS to properly manage the activities of its contractors on the LCD and all other issues, as well as supporting the concept of a moratorium to assure clarity through the end of the current administration and into the next.
Editor’s note: This story was adapted from materials provided by AOPA.