This article shares the Medicare reimbursement information that is known as of March 1, 2022 for two innovative technologies: the 3C Patch and the RECELL System.

3C PATCH

Effective April 13, 2021, the CMS revised National Coverage Determination (NCD) 270.31 entitled "Blood-Derived Products for Chronic, Non-Healing Wounds" and stated that the CMS will cover platelet-rich plasma (PRP) under certain specific conditions:

[horizontal ellipsis] 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.

Since April 2021, numerous Medicare Administrative Contractors (MACs) have revised their Local Coverage Determinations and Local Coding Articles (eg, First Coast Service Options, Inc;2,3 National Government Services, Inc;4,5 Novitas Solutions, Inc;6,7 and Palmetto GBA8,9) to align with the revised NCD.

To this author's knowledge, the only FDA-cleared product that currently meets the new NCD criteria is the 3C Patch System manufactured by Reapplix (Birkerod, Denmark). Wound/ulcer management professionals should pay close attention to the NCD guidance:

* Positive coverage only applies when using devices whose FDA-cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers.

* The NCD's positive coverage only applies to the treatment of chronic nonhealing diabetic wounds for a duration of 20 weeks.

If a wound/ulcer management professional deems it medically necessary to apply PRP to a chronic nonhealing diabetic wound beyond 20 weeks, the -KX modifier should be appended to the product's Healthcare Common Procedure Coding System (HCPCS) code on every Medicare claim after 20 weeks. The MAC will then determine if coverage and payment for the additional PRP are warranted. Likewise, each MAC will also determine if they will cover the use of PRP for any other chronic nonhealing, nondiabetic wound. CAUTION: Some MACs' Local Coverage Determinations have been revised to say that they will only cover PRP for use on chronic nonhealing diabetic wounds.

The coding guidance from the CMS has definitely been confusing. On September 10, 2021, the CMS issued a claims processing Transmittal (11119)10 that stated that the correct HCPCS code for the covered PRP procedure is as follows:

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

That same Transmittal requires two International Classification of Diseases, Tenth Revision diagnosis codes to be on the claim: one code for diabetes mellitus and one code for the chronic ulcer. The Transmittal also provides a complete listing of all the covered diagnosis codes.

Then on January 12, 2022, the CMS rescinded Transmittal 11119 and released a new claims processing Transmittal (11171),11 which revised the description of HCPCS code G0460 and created a new HCPCS code G0465 to distinguish diabetic from nondiabetic wounds.

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

New G0465: Autologous platelet-rich plasma (PRP) for diabetic chronic wounds/ulcers, using an FDA-cleared device (includes administration, dressings, phlebotomy, centrifugation, and all other preparatory procedures, per treatment)

Therefore, if wound/ulcer management professionals and providers are using the 3C Patch for diabetic chronic wounds/ulcers, they must be sure their electronic health records and charging systems include G0465.

Since January 12, 2022, several other Transmittals have been released. On January 20, 2022, the CMS rescinded Transmittal 11171 and replaced it with Transmittal 11214,12 which revised the implementation date for the MACs to February 14, 2022, provided further claims-processing direction to the MACs pertaining to G0460 and G0465, and included a list of covered diagnosis codes. On February 10, 2022, the CMS issued yet another Transmittal (11262).13 It describes how the Medicare Common Working File will edit the PRP claims for chronic nonhealing diabetic wounds/ulcers and for nondiabetic chronic wounds.

Many wound/ulcer management stakeholders have asked about the places of service where physicians and other qualified healthcare professionals (QHPs) can bill for HCPCS code G0465. To the best of this author's knowledge, physicians/QHPs may report HCPCS G0465 with the following place of service codes: 11, Office; 19, Off Campus-Outpatient Hospital; 22, On Campus-Outpatient Hospital; and 49, Independent Clinic.

Finally, let us discuss physician/QHP Medicare payment for HCPCS code G0465. Currently, it is left to the discretion of the MAC to establish facility and nonfacility relative value units and payment amounts for this procedure, generally on an individual basis following review of documentation. Therefore, physicians and QHPs should contact their MAC's medical director and educate him/her about the procedure, the benefit(s) to the Medicare beneficiary, and the cost to perform the procedure. This should assist the MAC medical director to establish adequate payment.

For hospital-owned outpatient wound/ulcer management provider-based departments (PBDs) that are paid according to the Outpatient Prospective Payment System, the CMS assigned HCPCS code G0465 to the Outpatient Prospective Payment System Ambulatory Payment Classification Group 5054. The 2022 Medicare national average allowable rate is $1,749.26 when the procedure is performed in on-campus or excepted (grandfathered) off-campus PBDs and is $699.70 when the procedure is performed in nonexcepted (not-grandfathered) off-campus PBDs.

For further reimbursement information pertaining to the use of the 3C Patch in physician/QHP offices, independent clinics, and PBDs, Reapplix has detailed reimbursement information on their website.14

RECELL SYSTEM

The RECELL System is indicated for the treatment of all sizes of acute full-thickness thermal burn wounds, in combination with meshed autografting for patients 1 month and older, and for acute partial-thickness thermal burn wounds in patients 18 years and older. Although most of these burns are managed in an inpatient facility, the CMS created a transitional pass-through-payment device code for PBDs to report when a physician/QHP performs the procedure in their facility. The HCPCS code created for the procedure is:

C1832: Autograft suspension, including cell processing and application, and all system components

To this author's knowledge, the only FDA-cleared product that currently meets this definition is the RECELL System (AVITA Medical, Valencia, California).

For this transitional pass-through-payment device, the PBD will receive a separate cost-based pass-through payment as long as the procedure is reported on the same claim with one of the two epidermal autograft codes:

15110: Epidermal autograft to trunk, arms, legs; first 100 sq cm or less

+15111: each additional 100 sq cm

15115: Epidermal autograft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 100 sq cm or less

+15116: each additional 100 sq cm

If a split-thickness autograft is also performed, the PBD may also report the applicable codes (15100-15101 or 15120-15121), but 15110 or 15115 must always be reported.

The CMS calculates the transitional pass-through device Medicare allowable rate for HCPCS code C1832 separately for each PBD based on the hospital's charge reduced to cost. Therefore, PBDs should carefully set the charge for the RECELL System by considering (1) the hospital's cost-to-charge ratio for Revenue Code 278 and (2) the cost of the RECELL System. NOTE: Similar to all other transitional pass-through-payment devices, HCPCS code C1832 is not subject to a Medicare beneficiary copayment.

Because HCPCS "C" codes are not used by physicians, the CMS instructs physicians to report one of the two epidermal autograft codes (15110-15111; 15115-15116) that are affiliated with the autograft suspension, processing, and application. If physicians also perform a split-thickness autograft during the same encounter, they may also report one of the two applicable codes (15100-15101 or 15120-15121), but 15110 or 15115 must always be reported.

For further reimbursement information pertaining to the use of the RECELL System by physicians in inpatient facilities, PBDs, and ambulatory surgery centers, AVITA Medical has a detailed reimbursement guide on their website.15

REFERENCES