1. Schaum, Kathleen D. MS

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The December 2018 Payment Strategies column discussed the new Local Coverage Determination (LCD) process that is more transparent and provides greater opportunities for wound management professionals, providers, manufacturers, and patients with chronic wounds to educate the Medicare Administrative Contractor (MAC) that determines their Medicare fee-for-service coverage about technology backed by clinical evidence that should be covered. This month's column addresses additional great news about the new LCD Reconsideration Process.


Although this author has often written about the LCD Reconsideration Process, wound management stakeholders have rarely used the process to challenge existing LCDs that are unclear, do not align with published clinical evidence, and so on. Some complaints heard from wound management stakeholders who attempted to use the old LCD Reconsideration Process often reported experiences including "We never heard back from the MAC;" "We received a letter that said we did not have enough evidence, but the letter did not say why the evidence was not adequate;" and "The response listed requirements for coverage that were never before made public." A few others successfully navigated the process, but most reported that the process differed from MAC-to-MAC.


Wound management stakeholders should be pleased that the Centers for Medicare & Medicaid Services (CMS) also revised the LCD Reconsideration Process on October 3, 2018. The new LCD Reconsideration Process will be implemented on January 8, 2019. Anytime stakeholders find themselves questioning why their MAC does not cover a wound management technology that has published evidence for its efficacy, they should check to see if their MAC has a published LCD that pertains to the technology. If the answer is yes, the next question to ask is "Does the LCD reflect current published evidence?" If the answer is no, the stakeholders should consider submitting LCD Reconsideration Requests now that the process is better defined.


What Is the LCD Reconsideration Process?

The LCD Reconsideration Process is a mechanism by which a beneficiary or stakeholder (including a medical society or physician) in the MAC's jurisdiction can request a revision to an existing LCD. Wound management stakeholders may request reconsideration of an entire LCD or any provision of an LCD. A MAC shall consider all LCD Reconsideration Requests from


* beneficiaries residing or receiving care in the MAC's jurisdiction,


* providers doing business in a MAC's jurisdiction, and


* any interested party doing business in a MAC's jurisdiction



The CMS dictates that MACs should only accept LCD Reconsideration Requests for published, final LCDs. Wound management professionals and providers should comment on proposed LCDs through the new LCD process that was described in last month's column. Further, LCD Reconsideration Requests shall not be accepted for other documents, including


* National Coverage Determinations (NCDs). If the requested modification of the LCD would conflict with an NCD, the request is not valid. The MAC should refer the requestor to the NCD reconsideration process:;


* coverage provisions in interpretive manuals;


* proposed LCDs;


* template LCDs, unless or until they are adopted and in effect by the MAC;


* retired LCDs;


* individual claim determinations;


* bulletins, articles, and training materials; and


* any instance in which no LCD exists, that is, requests for development of an LCD.



What Are the Requirements of the New LCD Reconsideration Process?

Each MAC shall add information on the LCD Reconsideration Process to its LCD website homepage. It shall be labeled "LCD Reconsideration Process" and shall include


* a description of the LCD Reconsideration Process and


* instructions for submitting LCD Reconsideration Requests, including postal, email, and fax addresses where requests may be submitted.



See the Table for links to each MAC's LCD Reconsideration Process information. NOTE: If stakeholders visited their MAC's website before January 8, 2019, they should revisit it again to read their MAC's instructions that should reflect the new LCD Reconsideration Process.


Requestors shall submit a valid LCD Reconsideration Request to the appropriate MAC by following the instructions on the MAC's website. All LCD Reconsideration Requests shall be submitted in writing and shall identify the language that the requestor wants added to or deleted from an LCD. Requests shall include a justification supported by new evidence, which may materially affect the LCD's content or basis. Copies of published evidence shall be included. Any request for LCD Reconsideration that is determined to not meet these criteria after MAC review is invalid. If similar LCD Reconsideration Requests are received, MACs have the discretion to consolidate valid requests.


Within 60 calendar days of the day the LCD Reconsideration Request is received, the MAC shall determine whether the request is valid or invalid. If the request is invalid, the MAC shall respond, in writing, to the requestor and shall explain why the request is invalid. If the request is valid, the MAC shall respond to the requestor, in writing, to notify the requestor of the LCD Reconsideration Request acceptance and (if applicable) waitlisting of the Reconsideration Request. Then the MAC shall open the LCD and (1) follow the same process as outlined in the December Payment Strategies for new LCDs or (2) include the LCD on the MAC's waiting list. This is great news because valid LCD Reconsideration Requests, just like proposed LCDs, will now travel through the notice, comment, open meetings, and final LCD publication process. In addition, the CMS requires MACs to keep an internal list of the LCD Reconsideration Requests received and the dates, subject, and disposition of each one. Therefore, if stakeholders report to the CMS that their LCD Reconsideration Request was ignored, the CMS can request the disposition list from the MACs.


In addition, the MACs shall publish all proposed and final LCDs and LCD-related articles on the Medicare Coverage Database (MCD). The public may access the MCD at The MACs must ensure the accuracy of the information published in the MCD. If a MAC decides to post LCDs and related articles on its own website, then the MAC shall link from their website to the MCD.



Along with your New Year's Resolution to take an active role in the new LCD Process, resolve to submit LCD Reconsideration Requests when they are warranted. The next time you read an LCD that does not align with published clinical evidence, take the time to submit an LCD Reconsideration Request. You can do this yourself, with your professional society, and/or with coalitions/alliances/patient advocacy groups that are impacted by the LCD. Remember, MACs must respond to your LCD Reconsideration Request in writing.


The CMS invites feedback on your experience with the new LCD Reconsideration Process and will consider additional revisions based on stakeholder feedback. Send your feedback to