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LCD Reconsideration Process

The Local Coverage Determination (LCD) Reconsideration process is a method by which interested parties may request a revision to an active LCD. CGS follows the Centers for Medicare & Medicaid Services (CMS) Program Integrity Manual (Internet-only Manual 100-08), Chapter 13 process for LCD Reconsiderations. The reconsideration process is available for final, effective LCDs only. The entire LCD or any part of it is subject to reconsideration. The process for LCD Reconsideration is outlined below.

Informal Teleconference (Optional)

Prior to submitting a formal LCD Reconsideration, the DME MACs encourage requestors to schedule an informal conference call to review the requirements for a valid LCD Reconsideration request.

DME MAC participation in the call may include DME MAC medical policy ancillary staff, in addition to the DME MAC Medical Directors, on behalf of each DME MAC jurisdiction. The Pricing, Data Analysis, and Coding (PDAC) contractor Medical Director(s) and ancillary staff may also be invited to attend these calls. (If you prefer that the DME MACs solely attend the informal conference call, then please specify such in your call request.)

A request for a call may be submitted via email to LCDReconJC@cgsadmin.com, and should include the following information:

  1. "Request for LCD Reconsideration Call – [Title of LCD]" in the subject line of the email
  2. Several options for dates and times for a call
  3. (Required) Teleconference number with enough lines to accommodate a minimum of 30 participants
  4. Summary information (1-2 paragraphs, maximum) for the LCD reconsideration request
  5. (Optional) A web link for you to visually present materials during the call. (Note: If you provide a web link, please know it is still required that a teleconference number be provided, as some attendees may not have access to the link at the time of the meeting.)

Once the DME MAC has received your informal conference call request, the DME MAC will communicate with you to confirm the date and time for participation in the meeting.

At least one week in advance of the confirmed informal conference call date, the DME MACs and PDAC* will anticipate receipt of an agenda, presentation documents (if applicable), and an attendee list (including participants’ names and titles who will attend on behalf of the informal conference call requestor). You should send these materials to each of the following email addresses:

Noridian Healthcare Solutions, DME MAC Jurisdictions A and D: DMERecon@noridian.com
CGS Administrators, LLC, DME MAC, Jurisdiction B: LCDRECONJB@cgsadmin.com
CGS Administrators, LLC, DME MAC, Jurisdiction C: LCDRECONJC@cgsadmin.com
Palmetto GBA, LLC, PDAC* Contractor: pdac.hcpcs@palmettogba.com

*If you specified in your informal conference call request that you prefer the DME MACs solely attend the call, then the PDAC will not attend the call and you may exclude the PDAC email address from the list of recipients to which you send the agenda, presentation documents (if applicable), and attendee list.

For your convenience, CGS has prepared an Informal Teleconference requestPDF form that you may fill out and submit with your informal conference call request. This form is optional.

LCD Reconsideration Request Submission Criteria (Required)

Following the informal discussion, should the requestor wish to continue with a formal LCD Reconsideration request, a valid request must meet all the following requirements:

  1. Be submitted by one of the following:
    • Beneficiaries residing or receiving care in a contractor's jurisdiction;
    • Health care professionals doing business in a contractor's jurisdiction; and
    • Any interested party doing business in a contractor's jurisdiction.
  2. Include the specific language that the requestor proposes to be added to or deleted from the LCD; and,
  3. Submission of all available evidence, as well as all related FDA approval correspondence, marketing designations, decision summaries pertinent to the product or service, 510(k)/PMA/De Novo notifications, SSED data sheet, FDA Panel Minutes and Post-Approval Study Result/Outcome Submissions. Submitted literature and references should be limited to published, full-text, peer-reviewed evidence, indexed in PubMed of the US National Library of Medicine, National Institutes of Health. The failure to include specific literature with the request will render the LCD request invalid.
  4. Only request reconsideration of an LCD published in final form. Requests will not be accepted for other documents including:
    • National Coverage Determinations (NCDs);
    • Coverage provisions in interpretive manuals;
    • Proposed LCDs;
    • Template LCDs, unless or until they are adopted by the contractor;
    • Retired LCDs;
    • Individual claim determinations;
    • Bulletins, articles, training materials; and
    • Any instance in which no LCD exists, i.e., requests for development of an LCD.

The level of evidence required for LCD reconsideration is the same as that required for new LCD development (see Program Integrity Manual, Chapter 13).

CGS has the discretion to consolidate valid requests if similar requests are received.

Any request for LCD reconsideration that, in the judgment of the contractor, does not meet these criteria is invalid.

CGS may revise or retire their LCDs at any time on their own initiatives.

If modification of the final LCD would conflict with an NCD, the request will not be valid. For information about the NCD reconsideration process, reference Medicare Coverage Determination ProcessExternal Website. Information about requesting an NCD or an NCD revision is found under "How to Request an NCD" in the Coverage Process section.

Health Disparities Analysis (Recommended)

Requestors are strongly encouraged to include an analysis of any relevant peer-reviewed medical literature that quantifies and/or describes any health disparities related to the specific LCD Reconsideration request, and how the requested change may impact health disparities.

LCD Reconsideration Request Letter Details

Request letters sent to the DME MACs are subject to public disclosure. By sending the DME MACs a request letter, the sender is consenting to public posting of the letter. The following list provides request letter details to consider when submitting the request to the DME MACs:

  1. Request letters sent to the DME MACs must be 508-compliant when submitted. If the request letter is not 508-compliant, it will be returned to requestor for correction. The 508 compliance instructions and information on the technical standards can be reviewed on CMS' Section 508 webpageExternal Website.
  2. Request letters must not contain protected health information (PHI) or personally identifiable information (PII). If the request letter contains PHI and/or PII, the requestor will be required to resubmit the request letter with the PHI/PII removed or redacted.
  3. Should the requestor include proprietary, privileged, or confidential information in the request, it is the requestor's responsibility to note such information. If proprietary, privileged, or confidential information is necessary for the validity of the reconsideration request, the requestor is asked to submit two versions of the request, one with proprietary, privileged, or confidential information redacted and one without redaction. The redacted version will be posted to the public.
  4. All valid request letters will be posted on the Medicare Coverage Database (MCD). Therefore, if a requestor provides personal contact information (such as phone numbers or email addresses), which the requestor does not wish to be publicly disclosed, then the requestor has the option to submit a redacted version of the request. The redacted version will be posted to the public.

If the requestor needs to submit a redacted version of the letter to the DME MAC, the requestor must provide the redacted version at the same time as providing the version without redaction.

How To Submit an LCD Reconsideration Request

For your convenience, CGS has prepared an LCD Reconsideration requestPDF form that you may fill out and submit with your request. This form is optional; however, it will assist you in ensuring the requirements for a complete request are met.

LCD Reconsideration requests may be sent via one of three methods: email (preferred), fax, or hard copy by mail. Pertinent information for each of the three methods is listed below:

  1. Email (Preferred Method): LCDReconJC@cgsadmin.com
    • Electronic requests should be sent with "LCD Reconsideration Request – [Name of LCD]" in the subject line.
    • If the attachment size for clinical citations exceeds 15 MB, the requestor must send the articles and supporting documents via multiple, smaller emails.
    • Please contact LCDreconJC@cgsadmin.com for alternative methods for submitting large electronic files or if you have difficulty submitting an LCD Reconsideration request.
  2. Fax: 615.664.5955
    • Please address your fax cover sheet to DME LCD Reconsideration – Attn: Dr. Robert Hoover.
    • Note: This fax line is only for the LCD reconsideration process described above. This is not the fax line for appealing individual claims (Redeterminations).
  3. Mail:

    CGS Administrators, LLC
    Attn: Robert D. Hoover, Jr., MD, MPH
    DME LCD Reconsiderations
    26 Century Blvd STE ST610
    Nashville, TN 37214-3685

Please note that this information is for DME MAC LCD reconsiderations only. Information for submitting an LCD reconsideration request for the Jurisdiction 15 A/B MAC may be found at the J15 LCD Reconsideration Process page.

Next Steps

CGS will review the materials received to determine whether the request is valid. A valid request must meet criteria 1-4 listed above. CGS will respond to the request within 60 calendar days upon receipt.

If CGS determines that the request is not valid, CGS will notify the requestor in writing that the request is not valid and will provide the rationale for this decision.

If the request is valid, CGS will begin the LCD development process outlined in the Program Integrity Manual Chapter 13 (Internet-only Manual Pub.100-08). The response to the requestor is an acknowledgement by CGS of the receipt of a valid, complete request. A request response from CGS does not convey that a determination has been made in regard to the likelihood of coverage or non-coverage under 1862(a)(1)(A) of the Act, but is confirmation that CGS plans to proceed with reconsidering the LCD or place the requested LCD reconsideration on the wait-list for development at a later time.

If the request is valid and the LCD is accepted for reconsideration, CGS will follow the process outlined in the Program Integrity Manual, Chapter 13. This involves:

  1. Consultation with the requestor or subject matter experts (if necessary);
  2. Contractor Advisory Committee (CAC) meeting (if necessary);
  3. Publication of a proposed LCD**;
  4. Open meeting to solicit comments from the public on the proposed LCD;
  5. Opportunity for public comment in writing (minimum of 45 days following posting of proposed LCD);
  6. Publication of a final LCD, including:
    1. A response to public comments received;
    2. Notice to public of the new policy at least 45 days in advance of the effective date.

**A proposed LCD will include the requestor's name and/or company information, along with a copy of the request. This information may also be included in other publicly available resources on the Medicare Coverage Database and/or the DME MAC websites.

Proposed LCDs will be finalized or retired within a rolling calendar year of publication date on the Medicare Coverage Database (365 days).

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