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National Coverage Determination (NCD)

Blood-Derived Products for Chronic Non-Healing Wounds

270.3

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Tracking Information

Publication Number
100-3
Manual Section Number
270.3
Manual Section Title
Blood-Derived Products for Chronic Non-Healing Wounds
Version Number
4
Effective Date of this Version
03/19/2008
Ending Effective Date of this Version
08/02/2012
Implementation Date
06/02/2008
Implementation QR Modifier Date

Description Information

Benefit Category
Incident to a physician's professional Service


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

Wound healing is a dynamic, interactive process that involves multiple cells and proteins. There are three progressive stages of normal wound healing, and the typical wound healing duration is about 4 weeks. While cutaneous wounds are a disruption of the normal, anatomic structure and function of the skin, subcutaneous wounds involve tissue below the skin's surface. Wounds are categorized as either acute, in where the normal wound healing stages are not yet completed but it is presumed they will be, resulting in orderly and timely wound repair, or chronic, in where a wound has failed to progress through the normal wound healing stages and repair itself within a sufficient time period.

Platelet-rich plasma (PRP) is produced in an autologous or homologous manner. Autologous PRP is comprised of blood from the patient who will ultimately receive the PRP. Alternatively, homologous PRP is derived from blood from multiple donors.

Blood is donated by the patient and centrifuged to produce an autologous gel for treatment of chronic, non-healing cutaneous wounds that persist for 30 days or longer and fail to properly complete the healing process. Autologous blood derived products for chronic, non-healing wounds includes both: (1) platelet derived growth factor (PDGF) products (such as Procuren), and (2) PRP.

The PRP is different from previous products in that it contains whole cells including white cells, red cells, plasma, platelets, fibrinogen, stem cells, macrophages, and fibroblasts.

The PRP is used by physicians in clinical settings in treating chronic, non-healing wounds, open, cutaneous wounds, soft tissue and bone. Alternatively, PDGF does not contain cells and was previously marketed as a product to be used by patients at home.
Indications and Limitations of Coverage

B. Nationally Covered Indications

Not applicable.

C. Nationally Noncovered Indications

  1. Effective December 28, 1992, the Centers for Medicare & Medicaid Services (CMS) issued a national non-coverage determination for platelet-derived wound-healing formulas intended to treat patients with chronic, non-healing wounds. This decision was based on a lack of sufficient published data to determine safety and efficacy, and a public health service technology assessment.
  2. Effective July 23, 2004, upon reconsideration, the clinical effectiveness of autologous PDGF products continues to not be adequately proven in scientific literature. As the evidence is insufficient to conclude that autologous PDGF in a platelet-poor plasma is reasonable and necessary, it remains non-covered for treatment of chronic, non-healing cutaneous wounds. Also, the clinical evidence does not support a benefit in the application of autologous PRP for the treatment of chronic, non-healing, cutaneous wounds. Therefore, CMS determines it is not reasonable and necessary and is nationally non-covered.
  3. Effective April 27, 2006, coverage for treatments utilizing becaplermin, a non-autologous growth factor for chronic, non-healing subcutaneous wounds, remains nationally non-covered under Part B based on section 1861 (s)(2)(A) and (B) of the Social Security Act because this product is usually administered by the patient.
  4. Effective March 19, 2008, upon reconsideration, the evidence is not adequate to conclude that autologous PRP is reasonable and necessary and remains non-covered for the treatment of chronic non-healing, cutaneous wounds. Additionally, upon reconsideration, the evidence is not adequate to conclude that autologous PRP is reasonable and necessary for the treatment of acute surgical wounds when the autologous PRP is applied directly to the closed incision, or for dehiscent wounds.

D. Other

In accordance with section 310.1 of the National Coverage Determinations Manual, the routine costs in Federally sponsored or approved clinical trials assessing the efficacy of autologous PRP in treating chronic, non-healing cutaneous wounds are covered by Medicare.

(This NCD last reviewed March 2008.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
83
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R83NCD.pdf
Revision History

05/2008 - On March 19, 2008, CMS issued a Decision Memorandum for the use of autologous blood-derived products for the treatment of chronic, non-healing wounds(autologous platelet rich plasma (PRP)) for treatment of acute wounds where PRP is applied directly to the closed incision site, and for dehiscent wounds. CMS issued a non-coverage determination for the use of Autologous PRP for the indications noted above. Current non-coverage for chronic, non-healing cutaneous wounds is maintained. This addition/revision of section 270.3 of Pub. 100-03 is a national coverage determination(NCD). Effective date: 03/19/2008. Implementation date: 06/02/2008. (TN 83) (CR6043)

06/2006 - CMS is correcting section 270.3, of the National Coverage Determinations (NCD) manual, entitled Blood-Derived Products for Chronic Non-Healing Wounds, by proposing to delete the following sentences, "Coverage for treatments utilizing becaplermin, a non-autologous growth factor for chronic non-healing subcutaneous non-healing wounds, will remain at local carrier discretion." Becaplermin is approved by the Food and Drug Administration. The correct statement should read, Coverage for treatments utilizing becaplermin, a non-autologous growth factor for chronic non-healing subcutaneous wounds, will remain nationally non-covered. Effective date: 04/27/2006. Implementation date: 07/10/2006. (TN 59) (CR5123)

07/2004 - Determined that autologous blood-derived products for chronic non-healing cutaneous wounds, both platelet-derived growth factor in a platelet-poor plasma, and platelet-rich plasma (PRP), remain noncovered. Coverage for becaplermin, a non-autologous growth factor for treatment of chronic non-healing subcutaneous wounds, remain at contractor discretion. Exceptions exist to cover routine costs in Federally sponsored or approved clinical trials assessing efficacy of autologous PRP in treating chronic non-healing cutaneous wounds. Effective and implementation dates 7/23/2004. (TN 19) (CR 3384)

12/1992 - Reflected noncoverage policy. Effective date 12/28/92. (TN 63)
Other

National Coverage Analyses (NCAs)

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
Blood-Derived Products for Chronic Non-Healing Wounds 6 04/13/2021 - N/A View
Blood-Derived Products for Chronic Non-Healing Wounds 5 08/02/2012 - 04/13/2021 View
Blood-Derived Products for Chronic Non-Healing Wounds 4 03/19/2008 - 08/02/2012 You are here
Blood-Derived Products for Chronic Non-Healing Wounds 3 04/27/2006 - 03/19/2008 View
Blood-Derived Products for Chronic Non-Healing Wounds 2 07/23/2004 - 04/27/2006 View
Platelet-Derived Wound Healing Formula 1 12/28/1992 - 07/23/2004 View
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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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