Payers Continue to Release Pertinent Coverage Policies

Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure accuracy. However, HMP and the author do not represent, guarantee, or warranty that coding, coverage, and payment information is error-free and/or that payment will be received.

At the 2021 SAWC Fall, this reimbursement consultant/educator/author was honored to provide a main session reimbursement presentation, as well as a 3-hour interactive reimbursement post-conference workshop. The attendees at both venues were very attentive and asked many excellent questions. On the plane ride home, this author reflected on the questions that were asked at both sessions and came to the conclusion that many wound/ulcer management professionals either 1) have not implemented a process for monitoring and reviewing pertinent payers’ coverage policies or 2) have not incorporated these important “playbook guidelines” into their wound/ulcer management assessments, care plans, coding selections (diagnosis, evaluation & management, procedure, and product), and documentation.

Approximately 90% of the attendees’ questions are clearly answered in their payers’ coverage policies. Three pertinent coverage policies that have been recently released are excellent examples of the vital information that will be missed if wound/ulcer management professionals do not read and implement coverage guidelines published in National Coverage Determinations (NCDs) released by the Centers for Medicare & Medicaid Services (CMS), Local Coverage Determinations (LCDs) and Local Coding Articles (LCAs) released by the Medicare Administrative Contractor (MAC) that processes their claims, and in the medical policies released by private payers. To gain a better perspective about coverage policies, let us review some of the highlights of these new policies.

NCD for Blood-Derived Products for Chronic, Non-Healing Wounds

In 2003, the CMS issued a national non-coverage determination for autologous platelet-derived growth factor. In 2012, the CMS provided coverage of autologous platelet rich plasma (PRP) only for patients 1) who have chronic non-healing diabetic, pressure, and/or venous wounds and 2) who are in CMS-approved coverage with evidence development (CED) studies.

Then a new NCD 270.3 Blood Derived Products for Chronic, Non-Healing Wounds¹ became effective for claims with dates of service on and after April 13, 2021. The CMS will now cover autologous PRP for the treatment of chronic non-healing diabetic wounds for a duration of 20 weeks, when the PRP is prepared by devices whose Food and Drug Administration (FDA)–cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers. 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.

The MACs implemented this new NCD on November 23, 2021, and the Shared Systems Contractors will implement it on January 3, 2022. Prior to this new NCD, many of the MACs’ LCDs and LCAs stated that PRP was not covered for any chronic wounds. Since the new NCD was released, several of the MACs (such as First Coast Service Options² and Novitas Solutions, Inc.³ have already revised their LCDs/LCAs to show that they are covering PRP in alignment with the new NCD. Even if the MACs do not release LCDs about this topic, they must follow the new NCD. However, coverage of autologous PRP for the treatment of chronic non-healing diabetic wounds beyond 20 weeks or for the treatment of all other chronic non-healing wounds will be determined by the MACs.

On November 10, 2021, the CMS issued a very thorough claims processing Transmittal 11119, which provides guidelines for the MACs and the wound care stakeholders.⁴ This author recommends that all wound care stakeholders who plan to incorporate autologous PRP into their treatment plans read this entire Transmittal. Some of the Transmittal highlights are:

•    The HCPCS code that applies to this newly covered service is G0460 Autologous platelet-rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration, and dressings, per treatment.

•    Two ICD-10 codes are required to support medical necessity: a Diabetes Mellitus code and a Chronic Ulcer code. The Transmittal provides a complete listing of all the covered diagnosis codes.

•    In the unlikely event that the autologous PRP treatment is required for 21 or more weeks, the KX modifier should be applied to the G0460 code.

•    Physicians, podiatrists, and QHPs can bill the Medicare Part B program when a covered autologous PRP treatment is performed in one of the following places of service:
     o    11         Office
     o    19         Off Campus—Outpatient Hospital
     o    22         On Campus—Outpatient Hospital
     o    49         Independent Clinic

•    The following types of bills can be used when covered autologous PRP treatments are performed in facilities that bill the Medicare Part A program:
     o    12x     Hospital inpatient Part B
     o    13X    Hospital outpatient
     o    22X    Skilled nursing facility inpatient Part B
     o    23X    Skilled nursing facility outpatient
     o    71X    Clinical rural health
     o    75X    Clinic comprehensive outpatient rehabilitation facility
     o    77X    Federally qualified health centers
     o    85X    Critical access hospital

The 2022 Medicare national average allowable rates for G0460 are:

•    Outpatient Prospective Payment System: $1,749.26 (APC Group 5054; Status Indicator “T”)

•    Medicare Physician Fee Schedule: MACs will establish relative value units and payment amounts for this service, generally on an individual case-by-case basis following review of documentation such as an operative/procedure report.

NOTES FROM AUTHOR:

•    If you wish to take advantage of this newly Medicare-covered technology, you should add G0460 to your charging systems and to your Charge Description Master.

•    Physicians, podiatrists, and QHPs should educate their MAC medical director about the value and cost of the technology.

LCD and LCA for Wound and Ulcer Care

Noridian Healthcare Solutions, a MAC for 16 states/territories released an LCD (L38904)⁵ and LCA (A58567)⁶ that became effective on November 28, 2021. If Noridian is your MAC, reading and following these guidance documents is imperative. If Noridian is not your MAC, reading these documents will provide you with examples of the specific wound/ulcer management guidelines that are provided in LCDs and LCAs. Some of the key points that this consultant/educator/author continuously emphasizes are clearly discussed in the LCD and LCA:

•    Wound evaluations should lead to a plan of care, to include a comprehensive medical evaluation, vascular assessment, and a metabolic/nutritional evaluation. Functional evaluations by different specialties and integration of physical therapy may also be of value. Noridian expects the wound care treatment plan to be modified if appropriate healing is not achieved. To acknowledge the difficulty in assembling all the assessment data in varied care settings, Noridian allows 30 days from the initial patient encounter to organize and enter a comprehensive Plan of Care in the Medicare Record. This should be maintained and updated as needed and should be available to the MAC upon request. Rural or underserved regions may benefit from evolving applications of telehealth to add expertise to the development of the Plan of Care, or revision thereof, should the patient prove refractory.

•    Surgical debridement will be considered not reasonable and necessary when documentation indicates the wound is without devitalized, fibrotic, nonviable tissue, infection, necrosis, foreign matter, or if the wound has pink to red granulated tissue. When surgical debridement is utilized, the frequency of debridement should decrease over time.

•    Frequent debridement suggests a need to reassess and reexamine the Plan of Care to ensure that clinicians are addressing all facets of care, such as pressure reduction, nutritional status, vascular insufficiency, and infection control.

•    Medical record documentation for debridement services must include the type of tissue removed, the depth, size, and other characteristics of the wound, and must correspond to the debridement service submitted on the claim. A pathology report substantiating depth of debridement is encouraged when billing for the debridement procedures involving deep tissue or bone. Documentation must include an operative note or procedure note (see LCD for required components).

•    Only a minority of beneficiaries who undergo debridements for wound care appear to require more than 12 total surgical debridement services in a 360-day period (5 which involve removal of muscle/fascia, and/or bone). It is unlikely that more than 4 debridements are needed in a month.

•    Noridian will not separately reimburse for dressing changes or patient/caregiver training in the care of the wound.

•    When a debridement is performed and an Unna boot or total contact cast is applied, only the debridement will be reimbursed.

•    Codes 11055–11057 represent paring. The medical record must reflect the symptomatic nature of the lesion that makes this a coverable service. The claim must have one of the 19 diagnosis codes listed in Group 2 and at least one of the diagnosis codes listed in Group 3 of the LCA. The LCA contains 49 pages of diagnosis codes that apply to the services and procedures described in the LCD.

•    The following procedures are considered part of an evaluation & management (E/M) service, and are not separately covered when an E/M service is performed:
     o    Removal of necrotic tissue by cleansing and dressing, including wet or dry-to-dry dressing changes
     o    Cleansing and dressing small or superficial lesions
     o    Removal of coagulated serum from normal skin surrounding an ulcer
     o    Decision making in the management of biofilm

•    E/M codes are not usually billed in conjunction with a debridement procedure. An E/M service provided and documented on the same day as a debridement may be covered by Noridian only when the documentation clearly established the service as a “separately identifiable service” that was reasonable and necessary, as well as distinct, from the debridement service(s) provided.

•    Wounds of some Medicare beneficiaries residing in skilled nursing facilities (SNFs) and nursing facilities (NFs) may not close, heal, or be amenable to self-care despite optimal therapy. Instead, the goals of wound care may include prevention of hospitalization and improvement in quality of life by minimizing the risk of infection and further progression of the wound, managing the multiple issues that cause patient and family suffering, and optimizing the patient’s function and quality of life.

NOTES FROM AUTHOR:

As you review the new LCD, you may find guidelines that may not be clinically correct or may be unclear. If you would like to request changes to the LCD, you may do so via the LCD Reconsideration Process.⁷ Following are a few items that you might wish to address:

•    The LCD incorrectly categorizes debridement as selective or non-selective. The LCA correctly categorizes debridement as active wound care management and surgical debridement. The LCD also incorrectly refers to surgical debridement as excision and incorrectly instructs to use the terms “full” or “partial thickness” to describe level of tissue debrided.

•    For negative pressure wound therapy (NPWT), the LCD refers to the coverage of durable medical equipment in the LCD L33821. However, the LCD does not provide any coverage guidelines for disposable NPWT.

Private Payer Medical Policy for Vacuum Assisted Wound Therapy in the Outpatient Setting

Contrary to the Noridian Healthcare Solutions LCD and LCA just discussed, on October 6, 2021, Amerigroup, an Anthem Company, published a medical policy⁸ that provides coverage guidelines for both NPWT durable medical equipment (DME) and disposable NPWT equipment. It clearly outlines when NPWT is/is not considered medically necessary. It also lists the relevant codes for both DME and disposable NPWT.

Like all private payer medical policies, the Amerigroup policy reminds the wound/ulcer management professionals and providers that they should refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of an NPWT service as it applies to the individual member. Finally, the medical policy lists some brand names of both DME and disposable NPWT equipment but reminds professionals and providers that the list is not intended to be a recommendation of one product over another and is not intended to be a complete list of all products available.

NOTES FROM AUTHOR:

•    The reminder by Amerigroup that coverage/non-coverage is dependent upon the member’s contract benefits is a perfect example of why this author always emphasizes the need to conduct insurance benefit verification before a new procedure is performed or a new product is ordered for patients with private insurance, Medicare Advantage, or Medicaid.

•    Private payers tend to release more wound/ulcer management medical policies than the MACs. Therefore, wound/ulcer management professionals and providers should always review the pertinent coverage policies from the top 10–20 payers who insure your patients.

Kathleen D. Schaum is a founding member of the Today’s Wound Clinic editorial advisory board and oversees a consulting business. She can be reached for consultation and questions by emailing kathleendschaum@bellsouth.net.

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References
1. National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds. Last accessed 12/6/21.

2. First Coast Service Options. Platelet Rich Plasma LCD. Last accessed 12/6/21.

3. Novitas Solutions, Inc. Platelet Rich Plasma LCD and LCA. Last accessed 12/6/21.

4. Medicare Claims Processing Transmittal 11119. Last accessed 12/6/21.

5. Wound and Ulcer Care LCD L38904. Last accessed 12/6/21.

6. Wound and Ulcer Care Billing and Coding Article. Last accessed 12/6/21.

7. Noridian LCD Reconsideration Process. Last accessed 12/6/21.

8. Amerigroup Vacuum Assisted Wound Therapy in the Outpatient Setting medical policy. Last accessed 12/6/21.