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, 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 (such as AutoloGel).

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.

B. Nationally Covered Indications

Effective August 2, 2012, upon reconsideration, The Centers for Medicare and Medicaid Services (CMS) has determined that platelet-rich plasma (PRP) – an autologous blood-derived product, will be covered only for the treatment of chronic non-healing diabetic, venous and/or pressure wounds and only when the following conditions are met:

The patient is enrolled in a clinical trial that addresses the following questions using validated and reliable methods of evaluation. Clinical study applications for coverage pursuant to this National coverage Determination (NCD) must be received by August 2, 2014.

The clinical research study must meet the requirements specified below to assess the effect of PRP for the treatment of chronic non-healing diabetic, venous and/or pressure wounds. The clinical study must address:

The required clinical trial of PRP must adhere to the following standards of scientific integrity and relevance to the Medicare population:

1. The principal purpose of the CLINICAL STUDY is to test whether PRP improves the participants’ health outcomes.
2. The CLINICAL STUDY is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
3. The CLINICAL STUDY does not unjustifiably duplicate existing studies.
4. The CLINICAL STUDY design is appropriate to answer the research question being asked in the study.
5. The CLINICAL STUDY is sponsored by an organization or individual capable of executing the proposed study successfully.
6. The CLINICAL STUDY is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46.
7. All aspects of the CLINICAL STUDY are conducted according to appropriate standards of scientific integrity set by the International Committee of Medical Journal Editors (http://www.icmje.org).
8. The CLINICAL STUDY has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements for coverage with evidence development (CED).
9. The CLINICAL STUDY is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.
10. The CLINICAL STUDY is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.
11. The CLINICAL STUDY study protocol specifies the method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (http://www.icmje.org). However a full report of the outcomes must be made public no later than three (3) years after the end of data collection.
12. The CLINICAL STUDY protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
13. The CLINICAL STUDY protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

Consistent with §1142 of the Social Security Act (the Act), the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.

Any clinical study undertaken pursuant to this NCD must be approved no later than August 2, 2014. If there are no approved clinical studies on or before August 2, 2014, this CED will expire. Any clinical study approved will adhere to the timeframe designated in the approved clinical study protocol.

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.

(Last reviewed August 2012)

CED page

09/2019 - 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)

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)

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)