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: + | –

March 2, 2023

LCD and Policy Article Revisions Summary for March 2, 2023

Outlined below are the principal changes to the DME MAC Local Coverage Determination (LCD) and Policy Article (PA) that have been revised and posted. The policy included is Glucose Monitors. Please review the entire LCD and related PA for complete information.

Glucose Monitors

LCD

Glucose Monitors LCD

Revision Effective Date: 04/16/2023

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:

Revised: Coverage criteria to separate initial coverage and continued coverage requirements
Removed: "with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump" from CGM coverage criterion pertaining to beneficiary being insulin-treated
Added: "The beneficiary's treating practitioner has concluded that the beneficiary (or beneficiary's caregiver) has sufficient training using the CGM prescribed as evidenced by providing a prescription" as a CGM initial coverage criterion
Removed: "The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump" from CGM coverage criteria
Removed: "The beneficiary's insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results" from CGM coverage criteria
Revised: Initial coverage criterion language pertaining to the in-person visit, to clarify that the visit may also be a "Medicare-approved telehealth visit"
Revised: Initial coverage CGM criterion language pertaining to the in-person visit, to change notation of "criteria (1-3) above" to "criteria (1)-(4) above"
Added: Initial coverage CGM criterion pertaining to history of problematic hypoglycemia
Revised: Continued coverage CGM criterion language pertaining to the in-person visit, to clarify that the visit may also be a "Medicare-approved telehealth visit" and that the practitioner must "document" adherence to the CGM regimen and diabetes treatment plan
Removed: "K0554" and "K0553" from reference to a non-adjunctive CGM device and associated supply allowance (respectively)
Added: "E2103" and "A4239" in reference to a non-adjunctive CGM device and associated supply allowance (respectively)

SUMMARY OF EVIDENCE:

Added: Information related to the modified coverage criteria for CGM

ANALYSIS OF EVIDENCE:

Added: Information related to the modified coverage criteria for CGM

BIBLIOGRAPHY:

Added: Section related to the modified coverage criteria for CGM

PA

Glucose Monitors PA

Revision Effective Date: 04/16/2023

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:

Added: "or Medicare-approved telehealth" to the in-person visit requirement as part of the initial and ongoing provision of a CGM
Removed: Language from criterion 1 regarding frequent dosing of insulin
Added: Language to criterion 1 regarding appropriate training received in the use of the CGM is evidenced by a prescription
Removed: Language from criterion 2 regarding frequent adjustment of diabetes treatment regimen
Added: Language to criterion 2 regarding the CGM is prescribed in accordance with FDA indications for use
Removed: Language from criterion 3 regarding at least one daily administration of insulin
Added: Language to criterion 3 regarding the CGM prescribed to improve glycemic control for insulin treated beneficiary
Removed: Language from criterion 4 regarding insulin dose adjustments not mandatory if glucose levels in target range and documented in the medical record
Added: Language to criterion 4 regarding medical record documentation of the beneficiary's history related to problematic hypoglycemia consistent with one of the pathways to coverage
Added: The two pathways to coverage under criterion 4
Removed: "on a daily basis" from use of the CGM device documentation in the medical record to determine the beneficiary continues to adhere to diabetes treatment regimen

MODIFIERS:

Removed: "not treated with insulin administrations" from when the KX modifier must not be used
Added: "exclusively treated with oral hypoglycemic agents" to when the KX modifier must not be used
Added: Language "initial coverage of non-adjunctive" for CGM devices and supply allowance related to the use of the CG modifier when billing codes E2103 and A4239
Added: Language regarding continued coverage of a non-adjunctive CGM device and supply allowance related to the use of the CG modifier when billing codes E2103 and A4239
Added: Language regarding continued coverage of adjunctive CGM devices incorporated into an insulin infusion pump, and supply allowance, related to the use of the CG modifier when billing codes E2102 and A4238

CODING GUIDELINES:

Removed: "Effective for claims with dates of service on or after 07/01/2017, the only products that may be billed using code K0554 are those that are specified in the PCL on the PDAC contractor web site."

03/02/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Note: The information contained in this article is only a summary of revisions to the LCDs and/or PAs. For complete information on any topic, you must review the LCDs and/or PAs.