For many years, this author has discussed the importance of commenting on proposed Local Coverage Determinations (LCDs) released by the Medicare Administrative Contractor (MAC) that makes coverage decisions for your patients insured by traditional Medicare. Unfortunately, many wound management professionals and providers believe that manufacturers should comment on proposed LCDs or pay wound management professionals and providers to comment when in fact the MACs place more credence in comments from professionals and providers than comments from manufacturers or persons paid by manufacturers.
In particular, one part of the LCD process, the closed Contractor Advisory Committee (CAC) meetings, has concerned wound management stakeholders. Each MAC maintained a CAC for each state within its jurisdictions. The names of the committee members were never publicly divulged, and the meetings, held no fewer than three times per year, were closed to the public. Therefore, wound care stakeholders did not know if physicians with wound care expertise participated in this nontransparent part of the LCD process. The purpose of each CAC was to offer
- a formal mechanism for physicians to be informed of and participate in the development of an LCD in an advisory capacity,
- a mechanism to discuss and improve administrative policies within MAC discretion, and
- a forum for information exchange between the MAC and physicians.
While the CAC reviewed all draft LCDs, the final decision about LCDs rested with the Contractor Medical Directors.
NEW LCD PROCESS ANNOUNCED
In accordance with the 21st Century Cures Act, the Centers for Medicare & Medicaid Services (CMS) created a new LCD process that is more transparent and intended to bring the latest technologies and innovations to Medicare beneficiaries. Chapter 13 of the Medicare Program Integrity Manual, Local Coverage Determinations, includes a step-by-step “roadmap” for stakeholders to navigate the new LCD process, as well as new policies and procedures that MACs must use to administer the Medicare fee-for-service LCD process. The official instruction CR10901, released on October 3, 2018, includes the complete manual revision: www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R829PI.pdf. Wound care stakeholders should be pleasantly surprised when they review the key parts of the new LCD process, which will be implemented on January 8, 2019.
New LCD Request Process
Interested parties within a MAC’s jurisdiction can now request a new LCD; they no longer have to wait for a MAC to propose a new LCD. The MACs shall consider all new LCD requests from
- beneficiaries residing in or receiving care in the MAC’s jurisdiction,
- healthcare professionals doing business in the MAC’s jurisdiction, and
- any interested party doing business in the MAC’s jurisdiction.
Prior to submitting a new LCD request, interested parties can request an informal educational meeting (to ensure that all relevant evidence needed for coverage review is submitted with the formal LCD request) with the MAC. The MACs should publish, on their websites, how interested parties can contact them to arrange the informal meeting.
All MACs shall consider a new LCD request to be a complete, formal request if the request
- is in writing and sent to the MAC via email, facsimile, or written letter;
- clearly identifies the statutorily defined Medicare benefit category to which the requestor believes the item or service pertains and provides a rationale that justifies assignment to that benefit category;
- identifies the language that the requestor wants in the new LCD;
- includes a justification supported by peer-reviewed evidence (full copies of published evidence to be considered shall be included; failure to include the evidence shall invalidate the request);
- includes information that addresses the relevance, usefulness, clinical health outcomes, or medical benefits of the item or service; and
- includes information that fully explains the design, purpose, and/or method, as appropriate, of using the item or service for which the request is made.
Within 60 calendar days of the day they receive the new LCD request, MACs will review the materials and determine whether the request is complete or incomplete. If the request is incomplete, the MAC shall respond in writing to the requestor and shall explain why the request was incomplete. If the request is complete, the MAC shall follow the new LCD process as described in the revised manual. NOTE: A valid new LCD request response does not convey that a determination has been made or whether the item or service will be covered. The response simply acknowledges that the MAC received a complete, valid, new LCD request.
New Requirement to Use Clinical Guidelines, Consensus Documents, and Consultation
Prior to drafting and during the development of an LCD, the MACs shall supplement their research with clinical guidelines and consensus documents, and consultations for advisory opinions from medical associations, healthcare professionals, or other experts who are recognized authorities in the field.
In conducting a review, MACs shall use the available evidence generally accepted by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements, and clinical guidelines. Proprietary information, submitted by the requestor, not available to the public, shall not be considered. Medicare data considered as part of the evidence review for an LCD shall also be reported in the evidence summary.
In every proposed and final LCD, the MACs shall explain the rationale that led to the coverage determination. The MACs shall list all articles and sources that led to the LCD in a bibliography. The MACs also must summarize the evidence that supports full coverage, limited coverage, maintenance of existing coverage (in cases of LCD reconsiderations), or noncoverage. At a minimum, the evidence summary should include
- a complete description of the item or service under review,
- a narrative that describes the scientific evidence supporting the clinical indications for the item or service,
- the target Medicare population, and
- whether the item or service is intended for use by healthcare providers or beneficiaries.
If the item or service is regulated by the FDA and determined by the MAC to be reasonable and necessary, information regarding the use of the item or service subject to federal labeling requirements shall be included.
New Proposed LCD Process
All proposed LCDs, with limited exceptions noted in the manual, shall follow the new proposed LCD process, which consists of consultation, the publication of proposed LCD with a minimum of 45 calendar days for public comment, an open meeting concerning the proposed LCD, an opportunity for public comment in person and in writing, the publication of a final LCD that includes a response to public comments received, and a public notice of the new LCD 45 days in advance of its effective date. The public announcement of a MAC’s proposed LCD begins with the date it is published on the Medicare Coverage Database (MCD) at www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.
If it is appropriate for a MAC to provide coding and billing information to help implement the LCD, the MAC shall publish a coding and billing article at the same time it publishes the proposed LCD.
New Response to Comments Article
All MACs shall respond to all timely public comments and may group similar comments and responses in logical categories in a Response to Comments (RTC) article that shall be published on the MCD on the start date of the notice period of the final LCD. The RTC Article will remain publicly available indefinitely on the MCD or the MCD Archive (https://localcoverage.cms.gov/mcd_archive).
New Open CAC Process
The purpose of the new CAC process is (1) to supplement the MAC’s internal expertise and to ensure an unbiased and contemporary consideration of “state-of-the-art” technology and science and (2) to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing the LCD and to promote communications between the MACs and the healthcare community. The CAC members should serve in an advisory capacity as representatives of their constituency to review the quality of the evidence used in the development of an LCD. The final coverage decision rests with the MACs.
Each MAC shall establish one CAC per state, or one per jurisdiction, with representation from each state. The MAC shall endeavor to ensure each specialty that serves on the CAC shall have at least one member and a designated alternate approved by the MAC. This will ensure that each state has a full committee and the opportunity to discuss the quality of evidence used to make an LCD decision. Participation in the CAC is voluntary. The MACs shall not provide an honorarium or other form of compensation to CAC members. Expenses are the responsibilities of the individuals or the associations they represent.
Most importantly, all CAC meetings will now be open for the public to attend and observe. Portions of the meeting not discussing evidence for a proposed LCD, such as provider practice trend reporting or discussions related to fraud and abuse, may be closed to the public. Therefore, MACs shall clearly identify in their proposed LCD the location, time, and date of open CAC meetings. The MAC should ensure that the CAC meeting information is clearly distinguished from the information for the open LCD meeting(s), even if they occur on the same day at the same location. All MACs have the option of hosting in-person or telephone/video/online meetings and shall record (video, audio, or both) the CAC meetings and (as part of the LCD record) maintain the recording on the MAC’s website. The MAC shall also make available a means to accommodate reasonable requests for assistance from stakeholders who are hearing or vision impaired.
New Process for Conducting Open LCD Meetings
After a proposed LCD is made public, MACs will hold open LCD meetings to discuss the review of the evidence and the rationale for the proposed LCD(s) with stakeholders in their jurisdiction. The MACs shall notify the public about the dates, times, location, and telephone/video/online conference information for open LCD meetings and shall ensure that this information is clearly distinguished from the information for the open CAC meetings. The MACs shall post the planned agendas for open LCD meetings on their website a minimum of 2 weeks prior to the events and shall inform the public that the agendas have been posted.
All MACs should endeavor to accommodate some in-person attendance, subject to limitations based on venue. Interested parties (generally those who would be affected by the LCD, including providers, vendors, manufacturers, beneficiaries, caregivers, etc) can present information related to the proposed LCDs. The MACs should provide an email address on their website where all interested parties can submit their presentation materials. In addition, all formal comments must be submitted in writing to the MAC. The MACs shall record (video, audio, or both) the open LCD meetings and ensure the recording is maintained on their website as part of the LCD record.
New Process for Publication of Final LCDs
The MACs shall finalize or retire all proposed LCDs within a rolling year of publication of the proposed LCD on the MCD. The MACs shall ensure that LCDs do not conflict with any statutes, rulings, or regulations; or national coverage, payment, and coding policies.
After the close of the comment period and the required meetings and consultations, the MACs shall publish the final LCD and the RTC on the MCD. The date the LCD is published marks the beginning of the required notice period of a minimum 45 calendar days before the final LCD can take effect. The effective date of the final LCD is the 46th calendar day after the notice period began. The MACs shall notify the public that a final LCD has been published and provide the link to the final decision online.
Other Important Changes to the New LCD Process
The MACs shall
- remove all codes from LCDs and place them in billing and coding articles or Policy Articles that are related to the LCD and
- maintain the LCD record for a minimum of 6 years 3 months from the date an LCD is retired.
Wound management professionals and providers should make a 2019 New Year’s resolution to take an active role in gaining Medicare coverage for services, procedures, and products backed by published clinical evidence. The new LCD process now provides wound care stakeholders, including patients, the opportunity to request new LCDs as well as to respond to proposed LCDs. Most important, wound care stakeholders can now meet with their MACs before requesting a new LCD, attend the open CAC meetings, provide comments about proposed LCDs, and attend open LCD meetings. Now is the time to take an active role in gaining coverage for technology that is needed by patients with chronic wounds.
The CMS invites feedback on your experience with the new LCD process and will consider additional revisions based on stakeholder feedback. Send your feedback to LCDmanual@cms.hhs.gov.
Next month we will discuss the new LCD reconsideration process. Stay tuned!