Washington, D.C. — A coalition of the six undersigned consumer and provider national organizations today welcomed the temporary reprieve announced by the White House in response to the “We the People” Petition to Rescind Medicare’s Proposed/Draft Local Coverage Determination (LCD) for Lower Limb Prostheses (DL-33787). The draft LCD was issued by Medicare contractors on July 16, 2015. A similar statement by the Centers for Medicare and Medicaid Services (CMS) confirmed that it “will not finalize” the draft policy that generated so much controversy among consumers and providers of prosthetic limbs, resulting in over 100,000 petition signatures in just 17 days this past August. Much work remains to be done on this draft policy, however, as the announcements today raise additional questions and concerns.
The announcement removes the most immediate threat to amputees who use artificial limbs to walk, function, and live independently. The Medicare contractors will not implement the ill-conceived and non-evidence-based draft coverage policy at this time, and this will continue to allow patients to have access to modern prosthetic limbs covered under existing Medicare policy. Considering how rare it is for CMS to reconsider LCDs, the White House/CMS announcement is a major first step forward and we commend them for listening to our concerns and putting a stop to the draft LCD. The decision underscores how patients with limb loss, prosthetists, physicians, rehabilitation providers, and members of the disability community can band together to effect positive change.
The White House/CMS announcements also indicate that CMS will convene a multidisciplinary “Lower Limb Prostheses Interagency Workgroup” in 2016. Based on the language of the CMS release, it does not appear that external consumer and provider stakeholders will be part of this working group, but CMS states that it “will ensure there is opportunity for public comment and engagement” with the Workgroup’s activities. The stated purpose of the Workgroup is 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.” It will be comprised of “clinicians, researchers, policy specialists, and patient advocates from different federal agencies” and will seek to identify evidence gaps and recommend study designs and outcome measures that inform “function, quality of life and service satisfaction” in this area.
The announcements raise a number of significant questions and concerns that we hope to work with CMS to resolve expeditiously, including:
Will the Medicare contractors formally rescind the draft LCD and remove both the draft LCD and the draft policy article from their websites as the “We the People” Petition requested, so that private insurers like United Healthcare will not continue to adopt draft CMS coverage policies for prosthetic care as if they represent evidence-based, final policy?
Will the draft LCD and related draft policy article be removed from the CMS’ Medicare coverage database accessible through their website to signal to patients and providers that it is being completely reworked?
How will the voices of patient advocates, external clinicians, rehabilitation physicians and therapists be heard if, as the CMS release suggests, the Workgroup consists only of federal government representatives?
Will the “consensus statement” developed by the Workgroup be used to merely tweak the draft LCD or will CMS and its contractors use it to review the existing prosthetic limb LCD in effect for years that has provided effective coverage to those with limb loss?
We are grateful that the Petition response confirms that the draft LCD will not be implemented at this time. However, we continue to believe that the draft LCD should be rescinded and that CMS should provide patient and provider stakeholders with a meaningful role in the development of future coverage policies for lower limb prostheses.
We look forward to continuing to work with CMS to resolve our questions and concerns about this important policy. Please contact Peter Thomas at 202-455-6550 or Peter.Thomas@ppsv.com for further information.
The undersigned organizations endorse this statement: