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National Coverage Determination (NCD)

Platelet-Derived Wound Healing Formula

270.3

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Tracking Information

Publication Number
100-3
Manual Section Number
270.3
Manual Section Title
Platelet-Derived Wound Healing Formula
Version Number
1
Effective Date of this Version
12/28/1992
Ending Effective Date of this Version
07/23/2004
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Drugs and Biologicals


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

Item/Service Description

A platelet-derived formula containing growth factors intended to treat nonhealing wounds (e.g., Procuren) is provided through hospital-based outpatient facilities as part of comprehensive wound- care programs designed to treat patients with chronic nonhealing wounds. It is usually applied at first in the presence of a physician, with the patient continuing applications at home.
Indications and Limitations of Coverage

There is a lack of sufficient published data to determine the safety and efficacy of the platelet-derived wound healing formula (based on a technology review by the Public Health Service). Therefore, it is not covered under Medicare because it is not considered reasonable and necessary within the meaning of §1862(a)(1) of the Act.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
63
Revision History

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