CMS Pub. 100-03, ch. 1, § 270.3

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, 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, 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.)