Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Platelet-Rich Plasma (PRPs) for Chronic Non-Healing Wounds and Stem-Cell Therapy for Orthopedic Applications
Policy #:MA07.008b

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

PLATELET-RICH PLASMA (PRP)

Platelet-rich plasma (PRP) for the treatment of all indications is considered experimental/investigational and, therefore, not covered, with the exception of Coverage with Evidence Development.

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
Autologous platelet-rich plasma (PRP) is eligible for coverage consideration for individuals who meet all the requirements of Original Medicare's Coverage with Evidence Development (CED) provisions for PRP and are enrolled in an Original Medicare--approved clinical study with either of the following indications:
  • A chronic non-healing diabetic wound
  • A pressure and/or venous wound

STEM-CELL THERAPY

Stem-cell therapy, alone or in combination with platelet-derived products (e.g., plasma, lysate), for orthopedic applications is considered experimental/investigational and, therefore, not covered, because the safety and/or effectiveness of these services cannot be established by review of the available published peer-reviewed literature.

BILLING REQUIREMENTS

Claims for individuals approved under the CED requirements for PRP should be submitted to the Company's Medicare Advantage plan.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, autologous platelet-rich plasma (PRP) is covered under the medical benefits of the Company's Medicare Advantage products when the requirements for Coverage with Evidence Development listed in this medical policy are met.

Subject to the terms and conditions of the applicable Evidence of Coverage, PRP and stem cell therapy for orthopedic applications are not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered experimental/investigational and, therefore, not covered.

Description

BLOOD-DERIVED PRODUCTS FOR CHRONIC NON-HEALING WOUNDS

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. Whereas a cutaneous wound is a disruption of the normal anatomic structure and function of the skin, a subcutaneous wound involves tissue below the skin's surface. Wounds are categorized as either acute (in which 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 which a wound has failed to progress through the normal wound healing stages within a sufficient time period).

Platelet-rich plasma (PRP) is produced in an autologous or homologous manner. Autologous PRP is composed of blood from an individual who will ultimately receive the PRP. Alternatively, homologous PRP is derived from blood from multiple donors. In autologous PRP, blood donated by the individual to receive the PRP is centrifuged to produce an autologous gel for treatment of acute wounds, as well as 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 include both platelet-derived growth factor (PDGF) products such as Procuren®, and PRP products such as AutoloGel™. 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.

STEM-CELL THERAPY FOR ORTHOPEDIC APPLICATIONS

Mesenchymal stem cells (MSCs) are multipotent stem cells (also referred to as stromal multipotent cells) that are able to differentiate into a variety of tissue types, including organs, trabecular bones, tendons, articular cartilage, ligaments, muscles, fats, and various musculoskeletal tissues. MSCs have possible orthopedic applications, which include the treatment of damaged bones, cartilage, ligaments, tendons, and intervertebral discs.

MSCs decrease as people age, and acute and chronic illnesses and diseases can tax stem-cell reserves. MSCs can be increased and stem-cell reserves replenished by treatment with drugs such as filgrastim injection (Neupogen®) and plerixafor injection (Mozobil®) to mobilize stem cells, or by autologous stem-cell transplantation. Although MSCs can be harvested from the bone marrow, harvesting requires an additional procedure that may result in donor site morbidity.

Tissues such as muscle, cartilage, tendon, ligaments, and vertebral discs show limited capacity for endogenous repair (i.e., the repair of cells within their own structures). Therefore, tissue engineering techniques have been developed to improve the efficiency of repair or regeneration of damaged musculoskeletal tissues. Using an engineered process to induce cell division and differentiation, without adverse effects such as the formation of neoplasms, remains a challenge.

According to the US Food and Drug Administration (FDA), "...Cell-based therapy is one of the most rapidly advancing approaches intended to repair, replace, restore, or regenerate cells, tissues, and organs. The cell-based therapies use immature stem cells that are expanded outside the body. The expanded cells are sometimes used in their immature state, but are often manufactured into mature cells before being used. Manufacturing a large number of cells outside the natural environment of the body may lead to ineffective or dangerous cells. It is important to control the production process and to define measures that reliably predict safety and efficacy of the cell-based products."

No products using engineered MSCs have been approved by the FDA for orthopedic applications. The FDA has determined that MSCs sold by Regenerative Sciences for use in the Regenexx Procedure (Regenerative Sciences, Colorado) would be considered drugs or biological products and thus require submission for a New Drug Application (NDA) or a Biologics Licensing Application (BLA) to the FDA. These procedures by Regenexx have platelet-derived components as well.

The literature overall suggests that this technology is in the early stages of development. Preliminary testing of tissue engineering has focused on animal models. Several clinical trials are in progress but are not expected to be completed for several years. Current information on procedures using autologous bone marrow derived from MSCs for orthopedic applications in humans consists mainly of case reports or case series with insufficient data to evaluate health outcomes. Therefore, the use of stem cells for orthopedic applications remains under investigation.
The American Association of Orthopaedic Surgeons (AAOS) states that stem-cell procedures in orthopedics are still at an experimental stage; most musculoskeletal treatments using stem cells are performed at research centers as part of controlled clinical trials.
References

American Academy of Orthopaedic Surgeons. Helping fractures heal (orthobiologics). [OrthoInfo Web site]. 01/2010. Available at: https://www.orthoinfo.org/en/treatment/helping-fractures-heal-orthobiologics/. Accessed on May 07, 2019.

Bauer SR; US Food and Drug Administration. Assuring safety and efficacy of stem-cell based products. Available at: http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/BiologicsResearchAreas/ucm127182.htm. Accessed on May 07, 2019.

Centeno CJ, Schultz JR, Cheever M, et al. Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther.2010;5(1):81-93.

Centeno CJ, Schultz JR, Cheever M, et al. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78.

Centers for Medicare & Medicaid Services (CMS). Decision memo for Autologous Blood-Derived products for Chronic Non-Healing Wounds. (CAG-00190R3). [CMS Web site]. 08/2/2012. Available at:http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=260. Accessed May 07, 2019.

Centers for Medicare & Medicaid Services (CMS). National Coverage Decision (NCD) for Blood Derived products for Chronic Non-Healing Wounds. (NCD 270.3) 3/19/2008. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=217&ncdver=4&NCAId=260&NcaName=Autologous+Blood-Derived+Products+for+Chronic+Non-Healing+Wounds&IsPopup=y&bc=AAAAAAAAEAAA&. Accessed May 07, 2019.

US Food and Drug Administration (FDA). 510(k) summary: Magellan™ Autologous Platelet Separator System. [FDA Web site]. 08/12/2002. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf2/K021902.pdf. Accessed on May 07, 2019.

US Food and Drug Administration (FDA). Guidance, compliance, & regulatory information (Biologics): Blood notices proposed and final rules. [FDA Web site]. 03/29/2019. Available at: https://www.fda.gov/vaccines-blood-biologics/biologics-rules/blood-notices-proposed-and-final-rules. Accessed on May 07, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

EXPERIMENTAL/INVESTIGATIONAL

0232T, 0481T, 0565T, 0566T

The following CPT codes are not specific to the service(s) described within this policy. When used to represent stem-cell therapy for orthopedic applications they are considered experimental/investigational.

38206, 38232, 38241



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



The following code is considered Experimental/Investigational unless the individual is enrolled in a study under Coverage with Evidence Development (CED)

G0460 Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures and administration, per treatment

The following code is always considered Experimental/Investigational

S9055 Procuren or other growth factor preparation to promote wound healing



Revenue Code Number(s)

N/A

Coding and Billing Requirements

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

To report platelet-rich plasma (PRP) injections, professional providers must use CPT 0232T.






Policy History

Revisions for MA07.008b:
01/01/2020This policy has been identified for the CPT code update, effective 01/01/2020.

The following codes have been added to this policy: 0565T, 0566T.

Language referring to the following code has been deleted from this policy: 20926.

Revisions for MA07.008a:
06/05/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Platelet-Rich Plasma (PRPs) for Chronic Non-Healing Wounds and Stem-Cell Therapy for Orthopedic Applications.
10/10/2018This policy has been reissued in accordance with the Company's annual review process.
01/01/2018Effective 01/01/2018, the following procedure code was added to this policy due to a coding update (the service(s) represented by this procedure code is considered experimental/investigational by the Company):

0481T

Revisions for MA07.008
06/07/2017This policy has been reissued in accordance with the Company's annual review process.
12/21/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Platelet-Rich Plasma (PRPs) for Chronic Non-Healing Wounds and Stem-Cell Therapy for Orthopedic Applications.
06/24/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Platelet-Rich Plasma (PRPs) for Chronic Non-Healing Wounds and Stem-Cell Therapy for Orthopedic Applications.
01/01/2015This is a new policy.





Version Effective Date: 01/01/2020
Version Issued Date: 01/03/2020
Version Reissued Date: N/A