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National Coverage Determination (NCD)

Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS)

250.5

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Tracking Information

Publication Number
100-3
Manual Section Number
250.5
Manual Section Title
Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS)
Version Number
1
Effective Date of this Version
03/23/2010
Ending Effective Date of this Version
Implementation Date
07/06/2010
Implementation QR Modifier Date

Description Information

Benefit Category
Physicians' Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

Treatment of persons infected with the human immunodeficiency virus (HIV) or persons who have Acquired Immune Deficiency Syndrome (AIDS) may include highly active antiretroviral therapy (HAART). Drug reactions commonly associated with long-term use of HAART include metabolic complications such as, lipid abnormalities, e.g., hyperlipidemia, hyperglycemia, diabetes, lipodystrophy, and heart disease. Lipodystrophy is characterized by abnormal fat distribution in the body.

The LDS is often characterized by a loss of fat that results in a facial abnormality such as severely sunken cheeks. The patient’s physical appearance may contribute to psychological conditions (e.g., depression) or adversely impact a patient’s adherence to antiretroviral regimens (therefore jeopardizing their health) and both of these are important health-related outcomes of interest in this population. Therefore, improving a patient’s physical appearance through the use of dermal injections could improve these health-related outcomes.
Indications and Limitations of Coverage

B. Nationally Covered Indications

Effective for claims with dates of service on and after March 23, 2010, dermal injections for LDS are only reasonable and necessary using dermal fillers approved by the Food and Drug Administration (FDA) for this purpose, and then only in HIV-infected beneficiaries when LDS caused by antiretroviral HIV treatment is a significant contributor to their depression.

C. Nationally Non-Covered Indications

  1. Dermal fillers that are not approved by the FDA for the treatment of LDS.
  2. Dermal fillers that are used for any indication other than LDS in HIV-infected individuals who manifest depression as a result of their antiretroviral HIV treatments.

D. Other

N/A

(This NCD last reviewed March 2010.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
122
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R122NCD.pdf
Revision History

12/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1580 ) (CR9252)

08/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1537) (CR 9252)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/06/2014 Effective date: 10/1/2015. (TN 1388) (TN 1388) (CR 8691)

09/2012 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/07/2013 Effective date: 10/1/2015. (TN 1122) (TN 1122) (CR 7818)

06/2010 - Effective for claims with dates of service on or after March 23, 2010, dermal injections for facial LDS are only reasonable and necessary using dermal fillers approved by the Food and Drug Administration for this purpose, and then only in HIV-infected beneficiaries who manifest depression secondary to the physical stigma of HIV treatment. Effective date: 03/23/2010 Implementation date: 07/06/2010 TN 122 (CR6953)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Dermal Injections for the Treatment of Facial Lipodystrophy Syndrome (LDS) 1 03/23/2010 - N/A You are here
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CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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