New LCD Request Process - JA DME
New LCD Request Process
The New Local Coverage Determination (LCD) Request Process is a mechanism by which interested parties within a contractor's jurisdiction may request a new LCD. This process has different requirements from an LCD Reconsideration Request, the path by which an interested party requests modification of an existing, active LCD. Information for requesting an LCD Reconsideration is available on the LCD Reconsideration webpage. The process for developing a new LCD is described below.
Informal Teleconference (Optional)
Prior to submitting a formal LCD request, the DME MACs encourage requestors to schedule an informal conference call to review the requirements for a valid LCD request. A request for a call may be submitted via email, and should include the following information:
- Include in the subject line of the email: "Request for New LCD Call - [Topic for New LCD]"
- Several options for dates and times for a call
- Teleconference number with enough lines to accommodate a minimum of 30 participants
- Agenda and presentation documents, including the requestor’s participants and titles, submitted one (1) week in advance of the call
- Summary information (1-2 paragraphs, maximum) for the LCD request
Request Submission Criteria (Required)
Following the informal discussion, should the requestor wish to continue with a formal new LCD request, a valid request must include all the following:
- 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.
- Clearly identify the statutorily-defined Medicare benefit category to which the requestor believes the item or service falls under;
- Provide a rationale justifying the proposed assignment of the Medicare benefit category;
- Identify the language that the requestor wants in a new LCD;
- 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 the specific literature with the request will render the LCD request incomplete.
- Must include information which addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service in the Medicare-eligible population; and,
- Must include information which fully explains the design, purpose, and/or method, as appropriate, of using the item or service for which the request is made.
The level of evidence required for LCD development may be found in the CMS Program Integrity Manual, Chapter 13.
Noridian has the discretion to consolidate valid requests if similar requests are received. Any request for a new LCD that, in the judgment of the contractor, does not meet these criteria is invalid.
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:
- 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 webpage.
- 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.
- 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 new LCD 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.
- 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 Request
New LCD requests may be sent via one of three methods: email (preferred) hard copy by mail, or fax. Pertinent information for each of the three methods is listed below:
- Email (Preferred Method)
- Electronic requests should be sent with "New LCD Request - [Topic for New 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.
- Email us for alternative methods for submitting large electronic files or if you have difficulty submitting a New LCD Request.
- Please address your fax cover sheet to DME New LCD - [Topic for New LCD] - Attn: JA Medical Director.
Note: This information is for NEW DME MAC LCD requests only. Information for submitting an LCD request for Jurisdiction E or F A/B MAC may be found at the JE or JF website.
Noridian will review materials received to determine whether the request is valid. A valid request must meet criteria 1-7 listed above. Noridian will respond to the request within 60 calendar days upon receipt.
If Noridian determines that the request is not valid, Noridian 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, Noridian 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 Noridian of the receipt of a valid, complete request. Noridian's request response 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 Noridian plans to proceed with development of a new LCD or place the requested LCD on the wait-list for development at a later time.
If the request is valid and a new LCD is developed, Noridian will follow the process outlined in the Program Integrity Manual, Chapter 13. This involves:
- Consultation with the requestor or subject matter experts (if necessary);
- Contractor Advisory Committee (CAC) meeting (if necessary);
- Publication of a proposed LCD*;
- Open meeting to solicit comments from the public on the proposed LCD;
- Opportunity for public comment in writing (minimum of 45 days following posting of proposed LCD);
- Publication of a final LCD, including:
- A response to public comments received;
- Notice to public of 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 web site (365 days).
Last Updated Tue, 13 Jun 2023 14:21:17 +0000