Medicare Coverage for Application of CTPs in Post-Acute Care Places of Service

Including an Interview with Martha R. Kelso, RN, CHWS, HBOT

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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.

Although wound/ulcer management has been provided in post-acute care places of service (POS) for many years, the COVID-19 Public Health Emergency (PHE) caused an increasing number of physicians and other qualified healthcare professionals (QHPs) to expand their services, particularly into skilled nursing facilities (POS 31), nursing facilities (POS 32), and patient homes (POS 12). Because these professionals successfully use cellular and/or tissue-based products (CTPs) for skin wounds in other POS such as inpatient hospitals (POS 21), hospital-owned outpatient wound/ulcer management provider-based departments (POS 19 and 22), and offices (POS 11), they naturally began using CTPs in the post-acute care POS. Some physicians/QHPs have received Medicare payments and even passed pre- and post-payment audits when they applied certain CTPs in one or more post-acute care POS. Other physicians’/QHPs’ claims for certain CTPs have been denied. In contrast, other physicians and QHPs have experienced recoupment of payments after audits for certain CTPs applied in post-acute care POS.

This author/consultant has provided education and consultation to manufacturers and wound/ulcer management professionals who intend to apply CTPs to patients in post-acute care POS about the four CTP reimbursement components (documentation, coding, coverage, and payment). Many of these stakeholders only wanted to know if the CTP they use/want to use has a code. However, the existence of a code does not guarantee coverage and payment or that payment will be retained post-audit. That is why this author/consultant continues to emphasize the following important points about reimbursement for CTPs in post-acute care:

• Before determining which CTPs to include on a post-acute care formulary, professionals should review the published clinical evidence for each CTP under consideration.

Then they should contact their Medicare Administrative Contractor (MAC) and their top 10–20 payers to verify coverage for the application codes (15271–15278) and the specific CTP product codes in the specific POS (eg, POS 12, 31, or 32) where the procedure will be performed.

In addition, the professionals should acquire and read all the payers’ pertinent medical policies. Because coding, coverage, payment, and audits are based upon published medical policies, professionals should use those policies to guide their medical decision-making, CTP ordering practices, documentation, etc. If their MAC does not have a Local Coverage Determination (LCD) and/or Local Coding Articles (LCA), the physicians/QHPs have a higher hurdle to document the medical necessity for the use of each CTP application and any wastage.

• Before performing a CTP application, professionals should always verify that each patient’s insurance is active on the day of application.
• If the patient has insurance different from original Medicare, professionals should always verify that the procedure and specific brand CTP code is covered on that patient’s plan when the procedure is performed by the particular physician/QHP who plans to apply the CTP and in the POS where the patient will receive the CTP application.

Because some payers only cover the application of CTPs to certain wound types, the professionals should also verify coverage for that patient’s specific ICD-10 diagnosis code(s).
 
Professionals should also verify if the payer has a limitation on the total number of CTP applications that can be performed in a specific time period.
 
If the specific CTP and procedure are covered on the patient’s plan, the professional should verify if prior authorization is required, the process for acquiring prior authorization, and the timeline to receive prior authorization.

• The Medicare Medically Unlikely Edits (MUEs) may influence the number of square centimeters of a particular CTP that the physician/QHP will apply on each date of service.
• CTPs should only be applied when the medical record clearly documents the medical necessity for that product on that specific chronic ulcer. The medical record should clearly document why a specific brand CTP was selected for a particular chronic ulcer.
• The medical record should include all the required assessment, diagnosis, and utilization elements, including the full description of the CTP application procedure: regardless of the POS where it is performed, the CTP application is a surgical procedure.

During this author’s education/consultations, some stakeholders challenged the validity of the reimbursement information provided. They often said, “I never do XXXXX, and I always get paid.” In addition, many stakeholders have said, “I listened to Martha Kelso, whose company manages ulcers in a wide variety of post-acute care places of service, and she says she always gets paid for the application of CTPs and passes all audits. She does not tell us that we must do everything that you say must be done.”

To verify that this author/consultant is providing correct reimbursement information, she requested an interview with Martha R. Kelso, RN, CHWS, HBOT, the founder and Chief Executive Officer for Wound Care Plus, LLC. Martha and her advanced wound care specialists provide services to patients in 22 states in skilled nursing facilities, nursing facilities, residential care facilities, group homes, assisted living facilities, acute care hospitals, long-term acute care hospitals, inpatient rehab facilities, and hospital-owned outpatient provider-based departments.

Kathleen D. Schaum, MS: Welcome, Martha, and thank you for agreeing to share the reimbursement processes that you and your team follow to apply CTPs specific to the three post-acute care settings (POS 12, 31, and 32) about which I receive the most push-back from the CTP manufacturers and the professionals who apply CTPs.

Martha R. Kelso, RN, CHWS, HBOT: Thank you for inviting me to share some wisdom from Wound Care Plus and our best practices for selecting, determining, and documenting medical necessity and applying CTPs in the 3 places of service. I have experience utilizing CTPs in these POS since 2011.

KDS: There are over 200 brands of CTPs on the market today. How does Wound Care Plus decide which CTPs to include on your post-acute care formulary?

MRK: First, we review the published evidence about each CTP brand that we consider. Because the payers tend to cover CTP brands with published evidence, Wound Care Plus uses that as our first decision point.

Then we contact, via email or payer portal, the MACs that process claims in the 22 states where we work. We verify if the application codes (15271–15278) and the specified CTP “Q” or “A” codes are payable when performed in POS 12, 31, and 32. We know that the existence of a CTP code does not mean it is covered and payable. NOTE: Manufacturers and professionals often make the mistake of only asking payers if the application codes are payable in each POS. Just because the application is payable does not mean that a specific product code of CTP is covered in a specific POS.

Because we prefer to receive the MAC’s response to our inquiries in writing, we prefer to contact the MACs via email or their portals rather than via the phone. The MACs have 45 business days to respond to inquiries. Therefore, stakeholders should send their inquiries well before needing to perform the work. See Table 1 for the best way to contact each MAC and Figure 1 for sample wording that usually elicits specific answers to CTP questions.

While waiting for the response from each MAC, we research whether the MAC has any LCDs and/or LCAs that address the specific brand CTP we are considering, as well as any documentation requirements or recommendations. This gives us time to update our electronic healthcare system, Charge Description Master, modifiers, or other needed items to ensure accurate documentation, coding, and submission through the clearinghouse.

Finally, we repeat the same process for each Medicaid program and for our top major commercial and private payers in the states where we work. Once all the payer research is complete, we use the published clinical evidence, the payers’ responses, LCDs, LCAs, and medical policies to determine if we should add a specific brand CTP to our POS 12, 31, and 32 formularies.

Before we move to the next question, I would like to share a few “next steps” to follow when payers say that the CTP application and/or brand is/are not payable or not covered, and they do not provide a reason:

1. Contact the payer again, or
2. Ask the payer contact to verify the information with another colleague or
3. Ask other physicians/QHPs to submit the same inquiry to that payer

NOTE: Multiple medical directors from private payers have informed Wound Care Plus, LLC that they only pay attention to requests to add specific products for payer coverage when they receive inquiries from more than 3 physicians/QHPs.

KDS: In general, are most of the MACs covering the application codes 15271–15278 in POS 12, 31, and 32?

MRK: Wound Care Plus, LLC has verified that all the MACs will pay and cover the application codes in POS 12, 31, and 32. However, that is only one half of the story: if the MAC does not cover a specific CTP brand (product code), the application code may not be covered and paid. As far as I can tell, this is because the claim is denied as not being medically necessary because the specific CTP brand is not covered. Therefore, the procedure code is denied as well.

KDS: Disparate information about CTP application in POS 31 is prevalent. Some physicians/QHPs report that they are paid by their MACs for the application and the CTP when they apply it in POS 31. Others report they are paid for the application but not for the CTP. Others report they are not paid for the application or the CTP. What is Wound Care Plus’s experience in POS 31, and do you have any thoughts about these disparate payment reports?

MRK: When providing care in POS 31, knowing whether the patient is in a Medicare Part A skilled stay before each application of a CTP is critical. Additionally, the patient may not have Part B benefits if they are in a Part A stay. Therefore, as soon as physicians/QHPs enter a skilled nursing facility, they should stop in the skilled nursing facility’s (SNF’s) business office and verify which patients are covered by Medicare Part A.

If the patient is in a covered Medicare Part A stay, the SNF is responsible for purchasing the CTP and does not receive any extra payment for the product. Unfortunately, most SNFs are not willing to purchase the expensive CTPs. That is why manufacturers and physicians/QHPs think Medicare does not pay for CTPs in POS 31. In addition, manufacturers, physicians, and QHPs often believe that the consolidated billing in SNFs prevents them from receiving payment for their work to apply CTPs. That is not true: the SNF Consolidated Billing list does allow physicians/QHPs to receive Medicare Part B payment for 15271–15278 while the patient is in a Medicare Part A skilled stay—if the professional can convince the SNF to purchase the CTP!

Armed with the knowledge about Medicare Part A stays in SNFs, here are my thoughts about the 3 disparate payment scenarios that you described:

• My experience is that physicians/QHPs, who are paid for the product and the procedure when performed in POS 31, have not reported the correct POS. In fact, many of them report the office POS code (POS 11), which can be considered a fraudulent claim. When these physicians/QHPs are audited, they usually incur large repayments.
• The physicians/QHPs who purchased and applied CTPs but were only paid for the application, usually applied them to patients in Medicare Part A skilled stays. The physicians/QHPs should have asked the SNF to purchase the CTPs. When providing services in a SNF setting, it is a federal requirement that the physician/QHP ask at every visit if the patient is in a Part A Medicare stay or on hospice. This must be documented in the medical record.
• The physicians/QHPs who were not paid for the CTP or the application usually did not verify if that payer covered that brand of CTP. If the product is not covered, the application may also be rejected for payment.

KDS: This author/consultant is receiving an increasing number of calls from physicians/QHPs who are being audited when they apply CTPs in all POS, including the 3 post-acute care settings that we are discussing. You mentioned that you have passed all your CTP audits. Will you please share with our readers some of the clinical protocols that Wound Care Plus follows and has aligned with auditors’ requirements?

MRK: Our clinical protocols ensure the following:

• Diagnostic tests are ordered to identify infection, to track that HgbA_1c is within a range that will not impede wound healing (usually below 9%), to determine if lower extremity blood flow/perfusion is adequate (by using arterial ultrasounds or near-infrared spectroscopy images), and to determine if the ulcer is free from infection (by using bacterial fluorescence and clinical signs and symptoms of infection)
• Adequate compression is supplied for venous ulcers
• Adequate offloading is supplied for pressure ulcers and diabetic ulcers
• Patient is adherent and is not using tobacco or nicotine (this is our protocol, but some payors also require this)
• Description of earlier treatments that failed
• Documentation of why a CTP is medically necessary, eg, the wound may worsen without the CTP application, the number of expected applications, etc.

Wound Care Plus, LLC has additional clinical protocols, but these are the ones that most payers expect.
 
KDS: Are you also encountering situations where physicians/QHPs have been incorrectly paid for applying CTPs due to incorrect coding and/or billing practices?

MRK: Yes, I hear about incorrect coding and billing practices all the time! The most frequent wrong or incorrect practice is when physicians/QHPs report incorrect places of service on their claims—eg, “physician/QHP office” (POS 11) or “Home” setting (POS 12), when, in fact, the patient was treated at a skilled nursing facility (SNF) (POS 31). This reporting of incorrect POS results in incorrect payment, fraudulent claims, repayments, and fines. These physicians, QHPs, and group practices do not seem to be aware of 1) the Medicare requirements for setting up a physician’s office in POS 31, and 2) that Medicare does not consider a SNF to be a patient’s home. Additionally, many physicians/QHPs do not understand the consolidated billing requirements before treating patients in a Medicare Part A (POS 31) stay. There are numerous requirements mandated by the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG).

Another frequent practice is not verifying that a patient’s consent is in place to supply these services, to bill the patient’s insurance, and to receive the assignment of benefits. Without the patient’s consent, there should be no touching, no treating, no billing, and no paying!

Another prevalent practice is reporting the code for a product that the payer covers rather than the code for the CTP that was applied. This can also be considered a fraudulent claim.

KDS: Would you be so kind as to share a checklist that readers should implement to help ensure documented medical necessity supports the application of CTPs?

MRK: Wound Care Plus, LLC has a robust CTP application process, which is stricter than most readers need to follow. Therefore, here are the minimal steps that physicians/QHPs should follow before they apply a CTP in places of service 12, 31, and 32:

✓ Verify the patient’s insurance. Remember that the Medicare payment system for the SNF is different than the payment system for the physicians/QHPs. Therefore, the payer listed on the patient’s face sheet in the SNF may not be the payer for the physicians/QHPs.

✓ If the manufacturer(s) of the CTP(s) that you use conduct insurance benefit verifications, verify that they will ask the payer all the questions that must be answered before you apply a specific brand CTP to a specific ulcer in a specific place of service.

If you feel confident that the manufacturer’s hotline conducts thorough benefit verifications, complete their data collection form and send it to them. This will serve as a second check to verify if the payor will/will not pay for the specific CTP for the specific ulcer type applied by the specific physician/QHP and in the specific place of service. Keep in mind that many payers only cover certain ulcer types, such as diabetic foot ulcers, lower extremity diabetic ulcers, or venous ulcers. Most payers also limit the number of CTP applications to the same ulcer.

✓ Document that the patient is under the care of a physician QHP for medical management of their systemic disease(s).
✓ Conduct and document a complete ulcer assessment (eg, ulcer size, tissue type, drainage, peri-wound) at every encounter.
✓ Document that the patient’s condition qualifies for a CTP because her/his ulcer did not respond to proper treatment despite the following (state all that apply):
    o   Pressure was removed or offloaded from the affected area.
    o   Patient was adherent to the prescribed treatment.
    o   Adequate compression was applied.
    o   Albumin is within normal limits.
    o   HgbA1c is not above 9%.
    o   Ulcer is free of signs or symptoms of infection.
    o   Blood flow to the area is adequate to encourage wound healing.
    o   Patient is tobacco-free.
    o   Wound is free of necrotic material and debris.
    o   Dressing choice has been adequate and applied as ordered.
✓ Document why you selected a particular brand of CTP by using statements such as:
    o   XXXXX CTP is designed to supply scaffolding for the recipient's skin and/or tissue to grow into the CTP.
    o   XXXXX CTP is intended to remain on the recipient.
    o   XXXXX CTP is supported by peer-reviewed evidence-based literature.
    o   XXXXX CTP supports the medically reasonable and necessary criteria described in the [LCD by the MAC, or medical policy by the payer]
    o   XXXXX CTP treatment consists of the fewest repeat applications and amount of product required to heal the ulcer.
    o   XXXXX CTP was used per the intended use as approved or regulated by the FDA.
✓ Document medical necessity for every CTP application that you perform by stating something like: “I certify that XXXXX CTP is medically necessary for this ulcer because [why you chose that brand CTP], that the ulcer bed is adequately prepared for the CTP, and that I expect [number—eg, 4, 10] applications will be necessary to close this ulcer.”
✓ Document the entire procedure, including ulcer bed preparation, the amount of CTP purchased, applied, and wasted; and how the CTP was secured (eg, with steri-strips, sutures, glue); the primary and secondary dressing used to manage drainage and to cover the CTP; offloading or compression when warranted; patient/caregiver education; and next steps.
✓ For every medically necessary reapplication, document that there has been a positive change in ulcer size or depth that indicates improvement is likely (eg, granulation, epithelialization, or progress toward closing). If the wound does not respond positively, we stop application immediately, reevaluate the wound, and will not apply again unless a cause for the deterioration is determined and addressed (ie, infection, etc.)
✓ Each patient at Wound Care Plus, LLC, who is being considered for application of a CTP undergoes a rigorous assessment before being approved for CTP application. On average, only one patient is approved for every 10 patients that are considered and that have payer coverage. That means 9 out of 10 patients are disqualified due to the above-mentioned requirements. If practices use the application of CTPs as a “get rich quick scheme,” we will lose coverage of this modality in these care settings. Part of the Medicare terms of participation for each one of us who bill Medicare is that we agree to prevent fraud, waste, and abuse. Wound Care Plus, LLC takes that commitment seriously to Medicare and to all other payers.

KDS: Martha, thank you for sharing the details of the thorough work that Wound Care Plus, LLC does before, during, and after applying CTPs in post-acute care settings. It is evident that you always get paid and always pass audits for work performed in places of service 12, 31, and 32 because you only use CTPs with published clinical evidence, and only apply a CTP after verifying that each payer covers the procedure and the specific CTP brand in each post-acute care POS. In addition, your impeccable assessments and thorough documentation support the medical necessity for the application.

I am honored that you agreed to this interview and am relieved to learn that the education and consultation I have provided, and will continue to provide, to manufacturers and physicians/QHPs align with the Wound Care Plus protocols.

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.   

Martha R. Kelso is the Chief Executive Officer and founder of one of the nation's largest mobile wound care providers. Kelso is considered a visionary and entrepreneur in mobile medicine with a relentless passion for education as a vehicle to elevate the art and science of wound healing. As a published author, clinical editor for multiple peer-reviewed publications, a legal expert witness for wound litigation, and a member of several national advisory boards, Kelso is widely recognized as an industry expert in the advanced wound care arena who works tirelessly to shape the future landscape of healthcare. National and international companies frequently use Kelso as a consultant to understand the landscape, reimbursement, and regulatory environment. This helps them position their products or devices for the wound care market, thereby assisting access to wound healing dressings, devices, and other wound modalities.
 
About Wound Care Plus, LLC
As our name implies, we are more than an advanced wound care specialty group. The PLUS means our skilled and caring advanced wound specialists can treat anyone with a wound or skin disorder at almost any location including hospitals, outpatient wound centers, long-term care, skilled nursing facilities, assisted living facilities, residential care communities and group homes. We bring advanced wound care, PLUS clinical excellence, and education for clients, families, caregivers, medical staff, and managers alike.
 
For more info, call (888) 256-3814 or go to
www.mywoundcareplus.com