On February 26, AOPA Executive Director Thomas Fise joined other representatives of the O&P Alliance for a meeting with CMS Deputy Administrator/Chief Medical Officer, Patrick Conway, M.D., Kate Goodrich, M.D., the Director of the Center for Clinical Standards & Quality, Susan Miller, M.D. who has responsibility for the planned Prosthetic LCD-related Interagency Committee comprised of Government Employees and other CMS staff in Baltimore to discuss the Prosthetic LCD. O&P reps were informed that the participants in the Inter-agency Committee have been identified. They are expected to generate a Consensus statement, likely to take about a year before it is complete, and that Consensus document is expected to be made available for public comment. Dr. Miller noted that the Consensus Statement, while spawned in the wake of the 2015 Prosthetic LCD, is really not about the LCD, but about Best Practices in the care of Medicare amputee beneficiaries. A question was raised about whether the public would be allowed the access, thus far denied, to be able to see the comments on the LCD, but it appears that that information may be made available to the Interagency Committee, but not to the public.
After inquiry, CMS reps stated that they would not be releasing the names of the persons comprising the Interagency Committee until that group’s work was complete about a year hence, and the participants may then be identified in the Consensus Statement. While CMS officials said they would take suitable input, especially new scientific articles, that there was not means by which public/stakeholder input from non-government individuals—Medicare amputees or others– could be incorporated into the Interagency Committee work until after release of the Consensus document.
O&P reps raised questions about the lack of transparency of this proposed approach. It was noted especially that one of the perceived difficulties with the draft LCD was that it came as a surprise without any stakeholder input, and that there was the possibility that the intended Interagency Consensus document might be perceived in the same light. CMS officials noted that to open the process to one meant opening the process to all, which would likely necessitate shifting to a Federal Advisory Committee process, which would mean the process would take longer.
O&P reps raised the issue of the continued presence of the draft LCD on the CMS and DME MAC websites. We were told that the draft LCD was an essential part of the record, and that it would be highly unusual for that to be removed from the website. It was noted that since none of the thousands of submitted comments were not available to the public, it would mean that really the draft LCD would be the only document, among thousands of comments and other materials in the record that was deemed as of sufficient critical importance to be available for website viewing under CMS/DME MAC’s masthead.
The O&P reps presented data on the reduction in Medicare spending for prosthetics in each of the past four years, 2010-14, a cumulative -15% reduction, as well as Medicare’s data showing that spending on advanced prosthetic devices for Medicare beneficiaries (K3 and K4) had dropped 41.6% over that 4 year period, while the Medicare spending on the cheaper less advanced (K1-K2) technology prosthetics had increased 49.9% over that same four-year period, clear evidence of a change in the standard of care for Medicare amputees, as well as that patients who have K3/K4 technology will now face an uphill battle in securing a comparable replacement when their current device wears out. Dr. Miller said that dollars are irrelevant to the Consensus statement, while O&P reps maintained that the evidence of a downshift in Medicare prosthetic standard of care is very germane to Best Practices. O&P reps also distributed a recent article outlining that a very substantial number of amputees never receive a prescription for a prosthetic device, and that with each advancing ten years of age, the prospect that an amputee receives such a prescription drops -50%, an especially relevant point for Best Practices since Medicare beneficiaries fall into those older patient age levels least likely to receive a prescription for a prosthesis, and thereby significantly reduced access to any prosthetic care.
Time will tell, but all reports are that it will take a year or so before we get a resolution to the question of whether (a) CMS takes the policy for lower limb prosthetics away from the DME MACs and pursues instead a National Coverage Determination; or (b) they decide after the Consensus Statement, to release the matter back to the DME MACs for them to resolve as they wish via one or more LCDs. AOPA, in its communications with legislators, has encouraged consideration both for Congressional oversight and potential clarification to assure that the HHS statutes and rules clearly allow CMS to properly manage the activities of its contractors on LCD and all other issues, as well as supporting the concept of a moratorium to assure clarity through the end of the Obama Administration and into 2017 and beyond the inauguration of the next President.