License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

End User/Point and Click Agreement: CPT codes, descriptions and other data only are copyright 2009 American Medical Association (AMA). All Rights Reserved (or such other date of publication of CPT). CPT is a trademark of the AMA.

You, your employees and agents are authorized to use CPT only as contained in the following authorized materials including but not limited to CGS fee schedules, general communications, Medicare Bulletin, and related materials internally within your organization within the United States for the sole use by yourself, employees, and agents. Use is limited to use in Medicare, Medicaid, or other programs administered by the Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.

Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT for resale and/or license, transferring copies of CPT to any party not bound by this agreement, creating any modified or derivative work of CPT, or making any commercial use of CPT. License to use CPT for any use not authorized here in must be obtained through the AMA, CPT Intellectual Property Services, 515 N. State Street, Chicago, IL 60610. Applications are available at the AMA website.

This product includes CPT which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable which were developed exclusively at private expense by the American Medical Association, 515 North State Street, Chicago, Illinois, 60610. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227-7015(b)(2)(June 1995) and/or subject to the restrictions of DFARS 227.7202-1(a)(June 1995) and DFARS 227.7202-3(a)June 1995), as applicable for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (June 1987) and/or subject to the restricted rights provisions of FAR 52.227-14 (June 1987) and FAR 52.227-19 (June 1987), as applicable, and any applicable agency FAR Supplements, for non-Department Federal procurements.

AMA Disclaimer of Warranties and Liabilities.

CPT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CGS or the CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.

CMS Disclaimer

The scope of this license is determined by the AMA, the copyright holder. Any questions pertaining to the license or use of the CPT must be addressed to the AMA. End Users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CPT. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

This license will terminate upon notice to you if you violate the terms of this license. The AMA is a third party beneficiary to this license.

POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

End User License Agreement

THE LICENSE GRANTED HEREIN IS EXPRESSLY CONDITIONED UPON YOUR ACCEPTANCE OF ALL TERMS AND CONDITIONS CONTAINED IN THIS AGREEMENT. BY CLICKING BELOW ON THE BUTTON LABELED "I ACCEPT", YOU HEREBY ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREED TO ALL TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT.

IF YOU DO NOT AGREE WITH ALL TERMS AND CONDITIONS SET FORTH HEREIN, CLICK BELOW ON THE BUTTON LABELED "I DO NOT ACCEPT" AND EXIT FROM THIS COMPUTER SCREEN.

IF YOU ARE ACTING ON BEHALF OF AN ORGANIZATION, YOU REPRESENT THAT YOU ARE AUTHORIZED TO ACT ON BEHALF OF SUCH ORGANIZATION AND THAT YOUR ACCEPTANCE OF THE TERMS OF THIS AGREEMENT CREATES A LEGALLY ENFORCEABLE OBLIGATION OF THE ORGANIZATION. AS USED HEREIN, "YOU" AND "YOUR" REFER TO YOU AND ANY ORGANIZATION ON BEHALF OF WHICH YOU ARE ACTING.

Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use CDT-4 only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of CDT-4 is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this agreement. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT-4. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials.
Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT-4 for resale and/or license, transferring copies of CDT-4 to any party not bound by this agreement, creating any modified or derivative work of CDT-4, or making any commercial use of CDT-4. License to use CDT-4 for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611. Applications are available at the American Dental Association website.
Applicable Federal Acquisition Regulation Clauses (FARS)\Department of Defense Federal Acquisition Regulation Supplement (DFARS) Restrictions Apply to Government use. Please click here to see all U.S. Government Rights Provisions.
ADA DISCLAIMER OF WARRANTIES AND LIABILITIES. CDT-4 is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values or related listings are included in CDT-4. The ADA does not directly or indirectly practice medicine or dispense dental services. The sole responsibility for the software, including any CDT-4 and other content contained therein, is with (insert name of applicable entity) or the CMS; and no endorsement by the ADA is intended or implied. The ADA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The ADA is a third-party beneficiary to this Agreement.
CMS DISCLAIMER. The scope of this license is determined by the ADA, the copyright holder. Any questions pertaining to the license or use of the CDT-4 should be addressed to the ADA. End users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CDT-4. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL COVERED BY THIS LICENSE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. If the foregoing terms and conditions are acceptable to you, please indicate your agreement by clicking below on the button labeled "I ACCEPT". If you do not agree to the terms and conditions, you may not access or use the software. Instead, you must click below on the button labeled "I DO NOT ACCEPT" and exit from this computer screen.

Print | Bookmark | Email | Font Size: + | –

Request for a New LCD Process

The New 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 may be found on the LCD Reconsideration page. 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.

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:

"Request for New LCD Call – [Topic for New LCD]" in the subject line of the email
Several options for dates and times for a call
(Required) Teleconference number with enough lines to accommodate a minimum of 30 participants
Summary information (1-2 paragraphs, maximum) for the LCD request
(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 request form that you may fill out and submit with your informal conference call request. This form is optional.

New LCD 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 which 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.

CGS 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.

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 New LCD request, and how the requested change may impact health disparities.

New LCD 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 a New LCD Request

For your convenience, CGS has prepared a New LCD request 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.

New LCD 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:

Email (Preferred Method): LCDReconJC@cgsadmin.com
- 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.
- Please contact LCDreconJC@cgsadmin.com for alternative methods for submitting large electronic files or if you have difficulty submitting a New LCD Request.
Fax: 615.664.5955
- Please address your fax cover sheet to DME New LCD – [Topic for New LCD] – Attn: Dr. Robert Hoover.
- Note: This fax line is only for the LCD process described above. This is not the fax line for appealing individual claims (Redeterminations).
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 NEW DME MAC LCD requests only. Information for submitting an LCD request for the Jurisdiction 15 A/B MAC may be found at the J15 website.

Next Steps

CGS will review the materials received to determine whether the request is valid. A valid request must meet criteria 1-7 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. CGS' 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 CGS 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, CGS 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:
1. A response to public comments received;
2. 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 (365 days).