Autologous Blood-Derived Products for Chronic, Non-Healing Wounds: Frequently Asked Reimbursement Questions

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An increasing number of physicians and other qualified healthcare professionals (QHPs) continue to incorporate autologous blood-derived products for chronic, non-healing wounds into the care plans of their patients. The increased utilization began 2½ years ago when the Centers for Medicare & Medicaid Services (CMS) released the National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds.¹ At first only two products aligned with the description of the code that CMS created to report the newly covered procedure. Then, in July 2023, CMS refined the description of the procedure codes, which then aligned with additional blood-derived products for chronic, non-healing wounds.

One other unrelated event is causing some physicians/QHPs to investigate other technologies to manage chronic, non-healing wounds. Last month, 3 Medicare Administrative Contractors (MACs) released future effective Local Coverage Determinations (LCDs) pertaining to skin substitute grafts/cellular and/or tissue-based products (CTPs) for the treatment of diabetic foot ulcers and venous leg ulcers. These future effective LCDs are causing some physicians/QHPs to investigate other available technologies, such as autologous blood-derived products.

Consequently, this author/consultant has been deluged with coding, coverage, and payment questions about the autologous blood-derived products procedure. The remainder of this article reviews the most frequently asked reimbursement questions that pertain to this procedure.

Q:        What is the appropriate code for reporting the autologous blood-derived products procedure performed on a chronic non-healing diabetic ulcer? Some of my coders say it is G0460 and others say it is G0465.

A:        Effective January 2022, the correct code for performing the procedure on patients with diabetes mellitus and chronic non-healing wounds/ulcers is G0465.

Q:        Will you explain how the code description of G0465 was refined effective July 1, 2023, and the implication(s) of the refinement?

A:        Table 1 shows a side-by-side comparison of the code description before and after July 1, 2023. The code description refinement now allows autologous blood- derived products, which do not require a centrifuge, to be included.

Q:       Prior to the new NCD, the MAC that processes my Medicare claims, as well as several other MACs, had an active LCD and Local Coverage Article (LCA), which stated that autologous blood-derived products were not covered for any chronic wounds/ulcers.

Have those MACs revised their LCDs and LCAs to align with the NCD?

A:        Yes, as of August 28, 2023, the following MACs revised their LCDs/LCAs and clearly cover the procedure for chronic non-healing diabetic ulcers: First Coast Service Options, and Novitas Solutions, Inc. If your MAC has not released an LCD/LCA about this procedure, they still must follow the new NCD and cover the procedure.

Q:       I have performed 2 autologous blood-derived product procedures for patients with chronic non-healing wounds/ulcers. I reported G0465 and one of the ulcer diagnosis codes for diabetes mellitus with ulcer. Both of my claims were denied as not medically necessary.

What more should I do?

A:        This is a perfect example of the importance of reading the entire NCD, including the directions that pertain to the covered diagnosis codes.² The directions clearly state that 2 diagnosis codes are required to support the medical necessity for the autologous blood-derived product procedure: one that describes the diabetes mellitus with ulcer and one that describes the anatomic location of the chronic ulcer.

If your claim was denied for lack of medical necessity, conduct a self-audit by verifying that:

• The patient’s diagnosis was documented in the medical record.
• Two diagnosis codes, required by the NCD, were reported on the claim.
• The diagnosis codes reported on the claim match the diagnoses documented in the medical record.

Q:       I have a non-diabetic patient who has a different type of chronic non-healing ulcer.
Is it possible that my MAC will cover the autologous blood-derived products procedure for that ulcer?

A:        The NCD clearly states that coverage for all other chronic-non-healing wounds/ulcers will be determined by the MACs. If your MAC has an active LCD and LCA, read the documents carefully to learn what they say about coverage for non-diabetic patients with chronic non-healing wounds/ulcers.

For example: The First Coast Service Options LCD states that “Platelet rich plasma injections and/or applications are considered not medically reasonable and necessary for any use outside of the National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic Non-Healing Wounds,” and their LCA states that “All PRP and related services provided outside of NCD 270.3 guidelines will be denied.” In addition, the First Coast Service Options LCA states that G0460 is not covered.

If your MAC does not have an active LCD and LCA, coverage will be based on documented medical necessity. Therefore, the physician’s/QHP’s documentation of medical necessity is vital.

CAUTION: Your MAC may automatically deny the claim with G0460 and non-diabetic diagnosis code(s). After the claim is denied, you will have to request a redetermination of the claim.
 
Q:       Do private payers cover G0465?

A:        Like all other wound/ulcer management services, procedures, and products, the only way to know if a particular private payer’s plan covers and pays for G0465 is to request an insurance benefit verification before performing the procedure. At that time, you should also ask if the payer has a medical policy pertaining to autologous blood-derived products, and if prior authorization is required.

Q:       The future effective CTP application LCDs and LCAs state that the “application of a CTP may be considered medically reasonable and necessary for certain patients with a Diabetic Foot Ulcer or Venous Leg Ulcer that has failed to respond to standard of care treatment after four weeks (defined as 30 days).”

Does the NCD for autologous blood-derived products contain similar language?

A:        Yes, the NCD states that the procedure may be used for “chronic, nonhealing cutaneous wounds that persist for 30 days or longer and fail to properly complete the healing process.”  

Q:       I am a physician in one of the Medicare jurisdictions that will be affected by one of the new future effective LCDs and LCAs that limit the number of CTP applications to 4. Many of the diabetic wounds/ulcers that I manage are quite large and often need more than 4 CTP applications.

If I submit a claim for more than 4 CTP applications, will the claim be denied?

If I use an autologous blood-derived product, does the NCD limit the number of applications?

A:        You are correct that the new future effective CTP application LCDs and LCAs limit the number of applications to 4. This author/consultant recommends that you pay attention to announcements from your MAC because the medical director may provide a method of reporting more than 4 applications for large wounds. Currently, if you apply CTPs more than 4 times on the same wound, your claim will most likely be denied by the MACs who released the future effective LCDs and LCAs. Then you can try to overturn the claim denial by requesting a redetermination.

Now, to answer your question about application limitations of the autologous blood-derived products: The NCD limits the number of applications to 20 weeks. In a Transmittal that was released about 6 months after the NCD was effective, CMS stated that the KX modifier (requirements specified in the medical policy have been met as reported on the claim) should be applied to G0465/G0460 in the unlikely event that the procedure is required for 21 or more weeks. In those unlikely cases, physicians/QHPs should meticulously document the medical necessity for the additional applications.

Q:        If a diabetic patient’s large chronic non-healing wound/ulcer progressed well with the 4 CTP applications covered in 12 weeks, and the physician/QHP assesses that the wound/ulcer still needs an advanced procedure, will the MACs then cover the application of an autologous blood-derived product?

A:        That is a great question. Unfortunately, neither the CTP application LCDs and LCAs nor the autologous blood-derived products NCD address this situation. Therefore, each MAC will determine the medical necessity based on the documentation in each patient’s medical record. Physicians/QHPs may also contact their MAC’s medical director and pose this question to him/her.

Q:       I am a physician who provides diabetic wound/ulcer management to patients in their homes.

Do you know if the autologous blood-derived products procedure is covered in patients’ homes?

A:        To the best of my knowledge, that procedure is not covered when performed in a patient’s home. To be sure, please check with your MAC.

Q:        Are there any special documentation requirements listed in the NCD?

A:        The NCD does not have a unique documentation section. If your MAC has an LCD and LCA, follow the documentation guidelines impeccably. In general, documentation should include, but not be limited to:

• History of the ulcer, including that the nonhealing wound/ulcer persisted for 30 days or longer, and the wound/ulcer failed to properly complete the healing process.
• Diagnostic test results
• Diagnosis(es) that link the patient’s diabetes and any other underlying conditions to the chronic ulcer.
• In-depth wound/ulcer assessment and plan of care that includes reason for the autologous blood-derived product procedure.
• Number of applications anticipated in a 20-week period.
• Complete procedure report (like an operative report) for each date of service
• Education provided to patient and/or caregiver.

Q:       I am a podiatrist who manages diabetic foot ulcers in my office and in an on-campus hospital owned outpatient wound/ulcer management provider-based department (PBD).

Does Medicare publish an allowable rate for G0465 on the PBD Outpatient Prospective Payment System (OPPS) fee schedule?

Does Medicare publish an allowable rate for G0465 on the Medicare Physician Fee Schedule (MPFS)?

A:        For 2023, G0465 is assigned to the OPPS Ambulatory Payment Classification (APC) group 5054 and has a national average allowable rate of $1,725.86 when the procedure is performed in an on-campus PBD.

NOTE: If the procedure is performed in a non-excepted off-campus PBD, the national average allowable is reduced to 40% of the OPPS rate, which is $690.34.
 
The CMS does not typically establish MPFS national allowable rates for HCPCS “G” codes. Therefore, each MAC medical director must establish relative value units and payment rates for the procedure. First, MAC medical directors may establish allowable rates on an individual case-by-case basis after the documentation (including the procedure report) is reviewed. Over time, the MACs may publish allowable rates on their website, such as First Coast Service Options, Noridian Healthcare Solutions, and Novitas Solutions, Inc. have already done.
           
Now let us pull the answers to this podiatrist’s questions together. When the podiatrist performs the autologous blood-derived procedure in her/his office, the patient and their MAC receive one bill for G0465. If all the coverage criteria are met, the podiatrist will be paid the allowable rate that her/his MAC has established, for place of service 11 (office).
           
When the podiatrist performs the same procedure in the PBD, the patient and their MAC receive two bills for G0465: one from the podiatrist and one from the PBD. If all the coverage criteria are met, the podiatrist will be paid the allowable rate for place of service 22 (on-campus-outpatient hospital), and the on-campus PBD will be paid their hospital’s OPPS allowable rate.

Q:       I am a physician in an office practice. If I selectively debride exudate and slough (97597) and then perform the autologous blood-derived products procedure on a diabetic foot ulcer (G0465), do the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) edits allow me to be paid for both procedures during the same encounter?

A:        According to the NCCI edits that were effective on July 1, 2023, both G0465 and 97597 may be paid together. If the coverage criteria are met, the highest paying procedure  will be paid at 100% and the lower-paying procedure will be paid at 50% because of the MPFS multiple procedure reduction rule.

Please note that a July 1, 2023, NCCI PTP edit does exist if the physician performs G0460 and 97597 at the same encounter. In that case, only G0460 may be paid, if it is covered.

CAUTION: The NCCI PTP edits can change from quarter to quarter. All physicians, QHPs, and PBDs should check the updated NCCI PTP edits every January 1, April 1, July 1, and October 1.

Q:        I am a program director of a PBD. My medical director insists that the PBD will be paid 100% for both a surgical debridement of subcutaneous tissue (11042) and the autologous blood-derived products procedure performed on a chronic non-healing diabetic foot ulcer (G0465). His reason is that an NCCI PTP edit does not exist for that pair of codes. I believe that the OPPS Status Indicator will cause the payment for the debridement to be reduced by 50%.

Who is correct?

A:        The medical director is correct that an NCCI PTP edit does not exist for that pair of codes, but he failed to consider the OPPS Status Indicator. Therefore, the program director is correct about the reduced OPPS payment. Both codes (11042 and G0465) are assigned the OPPS Status Indicator of “T” significant procedure, multiple reduction applies. Therefore, the code with the highest allowable rate (G0465) will be paid at 100% and the code with the lowest allowable rate (11042) will be paid at 50%.

NOTE: If an NCCI PTP edit existed for that pair of codes, that edit would override the OPPS Status Indicator. In that case, the PBD would only be paid for G0465.

Kathleen D. Schaum oversees her own consulting business and is a founding member of the Today’s Wound Clinic editorial advisory board. She can be reached for consultation and questions at kathleendschaum@gmail.com.

References
1. National Coverage Determination 270.3 Blood-Derived Products for Chronic Non-Healing Wounds: NCD - Blood-Derived Products for Chronic Non-Healing Wounds (270.3) (cms.gov). Last accessed 8/31/2023.
 
2. Centers for Medicare and Medicaid Services. List of covered diagnosis codes. Last accessed 8/31/2023.