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National Coverage Determination (NCD) for Blood-Derived Products for Chronic Non-Healing Wounds (270.3)

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Publication Number

100-3

Manual Section Number

270.3

Manual Section Title

Blood-Derived Products for Chronic Non-Healing Wounds


Version Number

3

Effective Date of this Version

4/27/2006

Ending Effective Date of this Version

3/19/2008


Implementation Date

7/10/2006


Benefit Category
Incident to a physician's professional Service
Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

Blood is donated by the patient and centrifuged to produce an autologous gel for treatment of chronic non-healing cutaneous wounds that persists 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 more recent products, (2) plateletrich plasma (PRP). 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. PRP is used by physicians in clinical settings. PDGF does not contain cells and was previously marketed as a product to be used by patients at home.

In latter 1992, CMS issued a national noncoverage determination for platelet-derived wound healing formulas intended to treat patients with chronic, nonhealing wounds. This decision was based on a lack of sufficient published data to determine safety and efficacy, and a Public Health Service technology assessment.


Indications and Limitations of Coverage

B. Nationally Covered Indications

Not applicable.

C. Nationally Noncovered Indications

  1. 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 noncovered for treatment of chronic, nonhealing cutaneous wounds.
  2. Additionally, the clinical evidence does not support a benefit in the application of autologous PRP for the treatment of chronic, non-healing cutaneous wounds. In light of the absence of data on the health outcomes of this treatment, CMS determines it is not reasonable and necessary and is therefore nationally noncovered.
  3. Coverage for treatments utilizing becaplermin, a non-autologous growth factor for chronic non-healing wounds, will remain nationally non-covered under Part B based on §1861(s)(2)(A) and (B) because this product is usually administered by the patient.

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 April 2006.)


Transmittal Number

59

Coverage Transmittal Link

http://www.cms.gov/transmittals/downloads/R59NCD.pdf

Revision History

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

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)

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)


Other Versions
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