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Have You Heard the Good News About the Medicare Coverage Process?
As the new year approaches, wound management professionals and providers are typically busy adjusting to new/changed codes for products, procedures, and diagnoses and to payment changes for their work facilities. Another game-changer was quietly released by the Centers for Medicare & Medicaid Services (CMS) on October 3, 2018, and deserves your immediate attention and consideration: the CMS released a new Local Coverage Determination (LCD) process that is transparent and open to all stakeholders, including Medicare beneficiaries. As you read the highlights about the new LCD process that will be implemented on January 8, 2019, you should be motivated to proactively participate in gaining Medicare coverage for items and services needed by your patients with chronic wounds.
Opportunities for Stakeholder Participation in the New LCD Process
LCD request process. Rather than waiting for Medicare Administrative Contractors (MACs) to create LCDs, interested parties now can request informal meetings with their MACs to discuss potential LCD requests, and they can use the new LCD request process to request creation of an LCD. The following stakeholders can submit a new LCD request:
• Beneficiaries residing or receiving care in the MAC’s jurisdiction;
• Health care professionals doing business in the MAC’s jurisdiction; and
• Any interested party doing business in the MAC’s jurisdiction.
New LCD process. When a MAC proposes a new LCD or proposes coverage changes to an existing LCD, the MAC is required to follow the new LCD process, which must consist of the following steps:
Consultation with experts on the topic of the proposed LCD. The Contractor Advisory Committee (CAC) and its meetings have been restructured. The CAC participants will be a variety of health care professionals (eg, physicians, nurses, social workers, and epidemiologists); beneficiary representation also must be included. CAC members will serve in an advisory capacity as representatives of their constituency to review the quality of the evidence used in the development of the proposed LCD. In addition, the CAC meetings now will be open to the public and are accessible in various ways, such as in person and via video and/or webinar.
Publication of proposed LCD. MACs must provide a standardized summary of the clinical evidence that supports their LCD decisions and coverage determination rationale. The summary should include:
• Complete description of the item or service;
• Narrative that describes the scientific evidence supporting the clinical indications for the item or service. MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews, meta-analyses, evidence-based consensus statements, and clinical guidelines;
• Target Medicare populations;
• Intended use by health care professionals or by beneficiaries; and
• United States Food and Drug Administration (FDA) labeling requirements for use of the item or service if it is regulated by the FDA and determined by the MAC to be reasonable and necessary.
Open LCD meeting. The CMS has repurposed the LCD public meetings. The purpose of the meetings will be for the MAC to present the proposed LCD, their review of the evidence, and their rationale for the proposed LCD. The MAC will post the meeting agenda a minimum of 2 weeks before the open LCD meeting. In addition, the MAC must provide various methods of participation, such as in person, telephone, or webinar.
Public comment period. The MACs will provide a minimum of 45 calendar days for public comment on all proposed LCDs.
Publication of the final LCD that includes Response to Comments (RTC) received from the public. MACs must respond to all public comments in an RTC article that shall be published on the start date of the notice period of the final LCD.
Public notice of final LCD 45 days in advance of the effective date. The date the LCD is published on the Medicare Coverage Database marks the beginning of the required notice period of a minimum of 45 calendar days before the LCD can become effective. The RTC article also must be published on the same date. If it is appropriate for the MAC to provide coding/billing information to help implement the final LCD, that information also shall be published in a coding/billing article on the same date.
New LCD reconsideration process requirements. Each MAC is required to include the LCD Reconsideration Process instructions on the LCD home page of its website. To be consistent with the National Coverage Determination Reconsideration Process, the MAC must follow the full LCD process for valid Reconsideration Requests. Most important, the MAC shall determine if the request is valid or invalid within 60 calendar days of receiving the LCD reconsideration request.
Now that you have read the highlights of the new LCD process, you are most likely thinking of one or more topics for which wound care stakeholders need LCDs, as well as one or more current LCDs that should be revised to align with current published evidence. As you can see, you no longer must wait for the MAC to act. You have every right to request a brand new LCD and/or to request reconsideration of a current LCD. In addition, you may be interested in contacting your MAC to offer your assistance on their CAC.
Because this new process is an opportunity to gain positive coverage for the technology your patients with chronic wounds need, you should take time in your day-to-day work to influence your MAC’s coverage decisions. Remember, 3 things are needed for reimbursement: coding, adequate payment rate, and coverage. If the technology is not covered, codes and adequate payment rates become irrelevant.
To read more about this exciting new LCD process, go to the Change Request CR10901, which includes the complete revision of Chapter 13 Local Coverage Determinations of the Medicare Program Integrity Manual, available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R829PI.pdf.
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