Blood-Derived Products for Chronic Non-Healing Wounds

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, 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, 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, nonhealing 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, and (2) PRP (such as AutoloGel).

The PRP is different from previous products in that it contains whole cells including white cells, red cells, plasma, platelets, fibrin, stem cells, and fibrocyte precursors.

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.

B. Nationally Covered Indications

Effective for services performed on or after April 13, 2021, the Centers for Medicare & Medicaid Services (CMS) will cover autologous PRP for the treatment of chronic non-healing diabetic wounds under section 1862(a)(1)(A) of the Social Security Act (the Act) for a duration of 20 weeks, when prepared by devices whose Food and Drug Administration-cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers.

C. Nationally Non-Covered Indications

Autologous PDGF for the treatment of chronic, non-healing cutaneous wounds, and,

Becaplermin, a non-autologous growth factor for chronic, non-healing subcutaneous wounds, and,

Autologous PRP for the treatment of acute surgical wounds when the autologous PRP is applied directly to the closed incision, or for dehiscent wounds.

D. Other

Effective for services performed on or after April 13, 2021:

Coverage of autologous PRP for the treatment of chronic non-healing diabetic wounds beyond 20 weeks will be determined by the local Medicare Administrative Contractors (MACs).

Coverage of autologous PRP for the treatment of all other chronic non-healing wounds will be determined by the local MACs under section 1862(a)(1)(A) of the Act.

(This NCD last reviewed April 2021.)

CED page

06/2022 - Transmittal 11400, dated May 4, 2022, is being rescinded and replaced by Transmittal 11460, dated, June 17, 2022, to update NCD 90.2, NGS, spreadsheet to conform with changes in CR 12124, and change the implementation date for all business requirements except 12705.6 to 30 days from issuance of this correction. All other information remains the same.(TN 11460) (CR12705)

05/2022 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11400) (CR12705)

04/2022 - Transmittal 11262, dated February 10, 2022, is being rescinded and replaced by Transmittal 11364, dated, April 27, 2022, to include new business requirement 2611.6 for new CWF requirements to FISS. All other information remains the same.(TN 11364) (CR12611)

02/2022 - Transmittal 11262, dated February 10, 2022, is to inform contractors of the CWF frequency editing for the NCD 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds. (TN 11262) (CR12611)

01/2022 - Transmittal 11171, dated January 12, 2022, is being rescinded and replaced by Transmittal 11214, dated, January 20, 2022 to provide clarification to the note in the Claims Processing business instructions, Pub.100-04, business requirement 12403.04-01 and to update the title for the NCD 270.3 Blood Derived Products for Chronic Non-healing Wounds attachment. This correction does not make any revisions to the companion publication 100-03; all revisions are associated with publication 100-04. All other information remains the same. (TN 11214) (CR12403)

01/2022 - Transmittal 11119, dated September 10, 2021, is being rescinded and replaced by Transmittal 11171, dated, January 12, 2022 to add HCPCS code G0465 to the instructions and to include additional information on HCPCS code G0460. This correction modifies the IOM attachment for publication 100-04, it also updates the background section for publication 100-04, and business requirements 12403 - 04.1 through 12403 - 04.2.2 and 12403 - 04.3 through 12403 - 04.6. This correction does not make any revisions to the companion publication 100-03; all revisions are associated with publication 100-04. All other information remains the same. (TN 11171) (CR12403)

11/2021 - Transmittal 10981, dated September 8, 2021, is being rescinded and replaced by Transmittal 11119, dated, November 10, 2021 to: (1) change Business Requirements (BRs) 12403 - 04.2, BR 12403 - 04.2.1 and BR 12403 - 04.2.2 to deny, (2) revise BR 12403 - 04.4.2.2 messaging, (3) add BR 12403 - 04.2.2.1 (4) remove Part A from BR 12403 - 04.3 and BR 12403 - 04.3.1, (5) revise verbiage in BR 12403 - 04.5, and extends the implementation date. This correction does not make any revisions to the companion publication 100-03; all revisions are associated with publication 100-04. All other information remains the same. (TN 11119) (CR12403)

09/2021 - The purpose of this change request is to inform MACs that effective April 13, 2021, CMS will cover autologous Platelet-Rich Plasma (PRP) for the treatment of chronic non-healing diabetic wounds under specific conditions. (TN 10981) (CR12403)

11/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.(TN 2200) (CR10859)

09/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.(TN 2138) (CR10859)

08/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding to feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2122) (CR10859)

01/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2005) (CR10318)

11/2017 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 1975) (CR10318)

06/2013 Transmittal 153, dated May 21, 2013, is being rescinded and replaced by transmittal 154, dated June 10, 2013 due to the language “randomized clinical trial” (RCT) inadvertently remaining in a paragraph in the Pub. 100-03 Manual. Additionally, the previous transmission erroneously omitted attachments that should have been included for both the Pub. 100-03 and Pub. 100-04 transmittals. The Transmittal 152, dated March 8, 2013, was rescinded and replaced by Transmittal 153, to add NCD disclaimer language to the transmittal page, and remove the language “random clinical trial (RCT)” from Pub. 100-03 Manual. All other information remains the same. (TN 154) (CR8213)

05/2013 Transmittal 152, dated March 8, 2013, is being rescinded and replaced by Transmittal 153, dated May 21, 2013 to add NCD disclaimer language to the transmittal page, and to remove the language “random clinical trial (RCT)” from Pub. 100-03 Manual. All other information remains the same. (TN 153) (CR8213)

03/2013 - Effective for claims with dates of service on or after August 2, 2012, CMS will cover autologous platelet-rich plasma (PRP) only for the treatment of chronic non-healing diabetic, venous and/or pressure wounds when PRP is provided under a clinical research study that meets specific requirements to assess the health outcomes of PRP for the treatment of chronic non-healing diabetic, venous and/or pressure wounds. Effective date: 08/02/2012. Implementation date: 07/01/2013. (TN 152) (CR6043)

09/2009 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 2362) (CR11392)

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)