December 2015 O&P Almanac

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This Just In

So there are big concerns remaining, even after the “will not finalize the draft LCD” announcement. Left on the websites of CMS and the DME MACs instead of being rescinded, the proposed LCD policy article could wreak havoc by appearing to be a work in progress and delivering harmful unintended consequences to amputees. That’s a big reason why the White House and CMS announcements did not elicit overwhelming praise from amputees and other stakeholders for CMS. To some extent, the hands of CMS may be tied when it comes to outright overruling an action by the DME MACs. CMS contractors enjoy a somewhat hands-off relationship, in part because of the way the HHS general counsel and inspector general have chosen to interpret statutory requirements that seek to avoid political influence over the policies implemented. That’s why there was cautious optimism conveyed to AOPA before the White House announcement by signaling that, indeed, the July 16 LCD would not be implemented in anything close to its original form. Clearly, navigating the shoals of government regulations is not always predictable or smooth, even when you’re part of the government supposedly in control. As of this writing, AOPA’s policy is to continue seeking full rescission of the proposed LCD as the next step will be for CMS to convene a multidisciplinary Lower-Limb Prostheses Interagency Workgroup in 2016. The charge, according to the official CMS statement that was released simultaneously with the White House email, will be to “develop a consensus statement that informs Medicare policy by reviewing the available clinical evidence that defines best practices in the care of beneficiaries who require lower-limb prostheses. The working group will be comprised of clinicians, researchers, and policy specialists from different federal agencies.” It’s a disappointment that stakeholders such as amputees and patients don’t have positions set aside at this

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federal agency table, although the White House email states, “CMS will ensure there is opportunity for public comment and engagement on the workgroup consensus statement and any related activity.” Bottom line, it could be a slow slog before any definitive policy is released by the CMS workgroup and even longer before it can be validated through the public comment and engagement process that CMS said would occur when the workgroup’s draft policy is completed. It will not happen overnight; in the meantime, amputees may face some remaining uncertainties relating to care and payment. Because of this uncertainty, AOPA will urge other stakeholders to encourage continual congressional and public monitoring, awareness, and vigilance on the existing lower-limb prosthetic policy, even though the near-term uncertainty for Medicare amputees has diminished markedly. It remains essential to ensure in the longer view that CMS and the DME MACs be reminded

of their obligation to observe the existing policy—a policy that is supported by ample scientific and medical evidence—unlike the proposed LCD, which would have reverted amputees to a 1970s standard of care. Vigilance will be required to respond to any further indications that private payors are revising their own payment policies, on the errant view of the draft LCD proposals, now put on hold. The draft still needs to be formally rescinded and removed from the websites of CMS and the DME MACs. Members are urged to make AOPA aware of any situations that appear to be penalizing amputee care based on the draft LCD provisions being inspiration for any payor policy changes. It’s now clear that the complicated web of regulations and the relationships between the DME MACs and CMS needs continued and constant scrutiny to ensure that the most advanced care and devices appropriate to an amputee’s needs are carefully protected in this interim period. O&P ALMANAC | DECEMBER 2015

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