CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non-Orthopedic Conditions

Defines coverage for autologous platelet-rich plasma (PRP) for wound healing and other non-orthopedic conditions for Blue Cross Blue Shield Rhode Island commercial and Medicare Advantage products, specifying covered indications, non-covered indications, coding notes, and relation to CMS NCD.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Recombinant and Autologous Platelet-Derived Growth Factors for Wound Healing and Other Non-Orthopedic Conditions

Policy CodePolicy N/A

Change TypeClarified

Effective DateMar 1, 2021

Next Review Date

Key ActionWhen billing Medicare Advantage Plans for autologous PRP for chronic non-healing diabetic wounds, submit the service with a covered diagnosis to qualify for coverage and limit to 20 weeks per CMS decision unless extended by local MACs.

SourceLink

POLICY UPDATE CHANGES

Policy applies only to autologous platelet-rich plasma (PRP).

1Covered Indications (Medicare Advantage)

MultipleCommercial Product Coverage Status

20 weeksCMS Coverage Duration for diabetic wounds

Coverage Summary

This policy defines coverage for autologous platelet-rich plasma (PRP) for wound healing and other non-orthopedic conditions for Blue Cross Blue Shield Rhode Island commercial and Medicare Advantage products. Coverage stance: mixed, with Medicare Advantage coverage limited and commercial products largely not covered. Effective date: 2021-03-01. Last review: 2024-12-13. Headline statistics: 1 covered indication for Medicare Advantage and multiple non-covered statuses for commercial products; CMS provides a 20 weeks coverage duration for chronic non-healing diabetic wounds under its NCD.

Policy Snapshot

Effective Date2021-03-01

Last Review2024-12-13

Coverage StanceMixed — covered for chronic non-healing diabetic wounds (Medicare Advantage); not covered/not medically necessary for most other indications (Commercial Products)

Scope SummaryDefines coverage for autologous platelet-rich plasma (PRP) for wound healing and other non-orthopedic conditions for Blue Cross Blue Shield Rhode Island commercial and Medicare Advantage products, specifying covered indications (chronic non-healing diabetic wounds), non-covered indications, coding notes, and relation to CMS NCD.

Medical-Necessity Criteria

Policy Statement - Covered Indications

Autologous platelet-rich plasma (PRP) is covered for the following when filed with a covered diagnosis:

Autologous platelet-rich plasma (PRP) is covered for the treatment of chronic non-healing diabetic wounds when filed with a covered diagnosis (Medicare Advantage Plans).

Policy applies only to autologous PRP preparations.

Policy Statement - Not Covered / Not Medically Necessary

PRP is considered not medically necessary for the following:

All other indications besides chronic non-healing diabetic wounds (e.g., venous stasis ulcers, pressure ulcers, surgical wounds, traumatic wounds) are not covered because evidence is insufficient to determine effects on health outcomes.

For Commercial Products: use of platelet-rich plasma (autologous blood-derived preparations) is considered not medically necessary for the treatment of acute or chronic wounds, including surgical wounds and nonhealing ulcers.

The CPT/HCPCS code G0460 is not covered for Medicare Advantage Plans and is not medically necessary for Commercial Products when used for non-diabetic chronic wounds/ulcers.

HCPCS code G0460: Autologous platelet rich plasma for non-diabetic chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment.

Medicare Advantage Specific Coverage

CMS national coverage decision details applicable to Medicare Advantage Plans:

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 for a duration of 20 weeks when prepared by devices whose FDA-cleared indications include management of exuding cutaneous wounds (e.g., diabetic ulcers).20 weeks

CMS NCD (April/March 2021) applies to Medicare Advantage Plans.

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

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

Provider Actions

Documentation Required

File with covered diagnosis for Medicare Advantage coverage

When billing Medicare Advantage Plans for autologous PRP for chronic non-healing diabetic wounds, submit the service with a covered diagnosis to qualify for coverage and limit to 20 weeks per CMS decision unless extended by local MACs.

CMS covers autologous PRP for chronic non-healing diabetic wounds for up to 20 weeks; extensions determined by local MACs.

Billing Rule

G0460 usage restriction

G0460 is identified as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products when used for non-diabetic chronic wounds/ulcers; do not bill or expect payment in those situations.

Affected code: G0460
Not covered for Medicare Advantage when used for non-diabetic chronic wounds/ulcers; not medically necessary for Commercial Products for that use.

Background & Evidence

Autologous PRP contains concentrated platelets derived from a patient’s own blood that release platelet-derived growth factors hypothesized to promote wound healing by stimulating fibroblasts, endothelial cells, and other repair processes.

PRP is prepared by centrifuging autologous blood to create a platelet-rich concentrate; activation (for example with thrombin and calcium chloride) degranulates platelets to release growth factors and can produce a platelet gel that is applied to wounds or used as a surgical adjunct.

The evidence base includes multiple small randomized controlled trials and systematic reviews/meta-analyses. For diabetic foot ulcers some meta-analyses and trials show improvement in outcomes such as complete wound closure and healing time, but many trials have moderate-to-high risk of bias and imprecision. For venous and pressure ulcers, results are mixed or show no clear benefit, and for acute surgical or traumatic wounds trials are small and of limited quality.

Overall, evidence is insufficient to determine net health benefit for many wound types, and coverage is limited accordingly (see Medicare NCD for chronic non-healing diabetic wounds).

Source	Summary
CMS NCD	Autologous PRP covered for chronic non-healing diabetic wounds up to 20 weeks when prepared by devices with FDA-cleared indications for exuding cutaneous wounds (March 2021).
Systematic reviews/meta-analyses	Multiple systematic reviews and meta-analyses of small randomized trials report mixed results — some improvement in diabetic ulcer outcomes but trials have moderate–high risk of bias and imprecision; overall evidence insufficient for many wound types.

Definitions:

• Autologous platelet-rich plasma (PRP): Autologous concentrate suspended in plasma prepared from centrifuged autologous blood, activated to release growth factors and applied as gel or adjunct to wounds.

Number	Name	Effective Date	Type
270.3 (related NCDs referenced)	Blood-derived products for chronic non-healing wounds	2021-03	NCD

Revision History

2021-03-01policy_effective

Policy effective date.

2021-03medicare_ncd

CMS national coverage decision: autologous PRP covered for chronic non-healing diabetic wounds for up to 20 weeks when prepared by FDA-cleared devices (NCD/Blood-derived products for chronic non-healing wounds).

2024-12-13last_reviewLatest

Policy last reviewed.

clarification