Wound/ulcer management stakeholders are probably familiar with the three components of reimbursement: coverage, coding, and payment. When new technology is in the development stage, manufacturers should plan the reimbursement pathway at the same time they plan the Food and Drug Administration pathway for market clearance. Once the technology is available for sale in the US, all wound/ulcer management professionals who believe their patients could benefit from it should do their part to educate the payers why the technology should be covered and assigned a code (if one does not already exist) and a fair allowable payment rate.
Let us reflect on the reimbursement journey of the autologous blood-derived products procedure that a growing number of physicians/qualified health professional (QHPs) are incorporating into their patients' care plans. Because the original developers of the autologous blood-derived products procedure did not create a reimbursement plan, conduct adequate clinical trials, or publish results in peer-reviewed journals, they had difficulty obtaining a code, payment rate, and-most important-payer coverage for the procedure. This lack of planning and early clinical evidence led to a 2003 Medicare National Non-Coverage Determination (NCD) for autologous platelet-derived growth factor.
That noncoverage NCD remained in effect until 2012, when the CMS provided coverage of autologous platelet-rich plasma (PRP) only for patients who 1) had chronic nonhealing diabetic, pressure, and/or venous wounds, and 2) participated in CMS-approved coverage with evidence development (CED) studies. Based on the outcomes and published evidence of the CED studies, a new positive NCD 270.3 Blood Derived Products for Chronic, Non-Healing Wounds became effective for claims with dates of service on and after April 13, 2021.1 This positive NCD led the CMS to revise the procedure codes and code descriptions several times in the past 2 years, and increased physician/QHP utilization and payer education is leading to published payment rates by a growing number of Medicare Administrative Contractors (MACs).
This 18-year reimbursement detour could have been avoided if the early developers of the technology had created reimbursement plans that included clinical evidence. Thanks to other manufacturers who had proactive reimbursement plans and participated in the Medicare CED studies, patients with chronic nonhealing diabetic ulcers now have access to various autologous blood-derived products procedures.
Medicare Coverage
Autologous blood-derived products procedures for the treatment of chronic nonhealing diabetic wounds are covered by all MACs for a duration of 20 weeks when the procedure is performed with devices whose Food and Drug Administration-cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers. However, coverage of autologous blood-derived products procedures for the treatment of all other chronic nonhealing wounds is decided by each MAC. Thus, if physicians/QHPs decide that the procedure is medically necessary for wounds/ulcers that are not diabetic ulcers, they should first check if their MAC released a local coverage determination or local coding article that addresses coverage for nondiabetic wounds/ulcers. For example, First Coast Service Options has an local coding article that states nondiabetic chronic wounds/ulcers are not covered.
The NCD also specifies three nationally noncovered indications:
1. Autologous platelet-derived growth factor for the treatment of chronic, nonhealing cutaneous wounds
2. Becaplermin (a nonautologous growth factor) for chronic, nonhealing subcutaneous wounds
3. Autologous PRP for the treatment of acute surgical wounds when applied directly to a closed incision or a dehisced wound.
Many physicians/QHPs have asked if Medicare covers this procedure when performed outside of the office. Physicians/QHPs can perform and be paid by Medicare for autologous blood-derived products procedures at the following places of service:
* 11 Office
* 19 Off-campus hospital outpatient provider-based department
* 22 On-campus hospital outpatient provider-based department
* 49 Independent clinic - A location, not part of a hospital and not described by any other Place of Service code, which is organized and operated to provide preventive, diagnostic, therapeutic, rehabilitative, or palliative services to outpatients only.
CODING
The CMS created two codes for the autologous blood-derived products procedures: G0460 for nondiabetic chronic wounds/ulcers and G0465 for diabetic chronic wounds/ulcers. Because some procedures do not require use of a centrifuge, the CMS recently refined both code descriptions (Table).
In the event that the procedure is required for 21 or more weeks, the physician/QHP should document the wound/ulcer's continued progress and why additional applications are needed. Further, the -KX modifier (requirements specified in the medical policy have been met as reported on the claim) should be appended to the procedure code on all claims from week 21 onward.
If you perform these procedures, verify that your Charge Description Master and charging system clearly indicate that G0460 is only for nondiabetic chronic wounds and G0465 is only for diabetic chronic wounds/ulcers. Physicians, QHPs, and provider-based departments (PBDs) have reported that their claims for the procedure were denied by their MAC. When this author reviewed their submitted claims, it was clear that the procedure was performed on a diabetic wound/ulcer, but the incorrect code was submitted on the claim. Once these stakeholders submitted the correct code for applications to diabetic wounds/ulcers (G0465), their MACs paid the claims.
If the patient has a chronic diabetic wound/ulcer, CMS requires two ICD-10 diagnosis codes to be reported on the claim: one for the diabetes mellitus and one for the chronic ulcer.2 If both codes are not reported on the claim, the claim will be denied for lack of medical necessity.
MEDICARE PAYMENT
When the autologous blood-derived products procedure for chronic nonhealing wounds/ulcers is performed in an on-campus PBD, the PBD should report G0465 for the procedure, along with the two required diagnosis codes. That code is assigned to the Outpatient Prospective Payment System Ambulatory Payment Classification group 5054, which has a national average allowable rate of $1,725.86. If the procedure is performed in a nonexcepted off-campus PBD, that national average allowable rate is reduced by 60%.
There is no published rate for G0465 on the Medicare Physician Fee Schedule because the CMS does not usually establish these allowable rates for HCPCS "G" codes. Instead, each MAC medical director determines the allowable rate for the procedure. Physicians/QHPs should educate their MAC medical director as to how the procedure clinically benefits patients, its cost to perform, and any cost savings achieved with its use, and request that the medical director publish a fair allowable rate for G0465 on the MAC website.
DOCUMENTATION
Appropriate documentation should follow the payers' documentation guidelines and minimally include:
* The patient is under the care of a physician/QHP for treatment of his/her systemic disease.
* History and duration of the wound/ulcer and its treatment
* Description of each ulcer at every encounter, including an in-depth assessment, diagnostic test results, and plan of care
* Diagnoses linking the wound/ulcer to the patient's diabetes and any other underlying conditions
* Medical necessity for the autologous blood-derived products procedure
* Complete procedure notes (like an operative note) for each date of service, including the place of service where the procedure was performed.
* If more than 20 applications are applied, document the progress so far and the reason for each application above 20.
REFERENCES