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.
In last month’s Business Briefs column, we discussed 5 revenue cycle resolutions that wound/ulcer management professionals should make for 2020. The first resolution that we discussed was to work with all members of your clinical and revenue cycle teams. This month we will review some products and procedures that have been assigned or will be assigned new codes. If you intend to use these products or perform these procedures, you should work with your clinical and revenue cycle teams to integrate the new codes into your processes.
Cellular- and/or Tissue-Based Products (CTPs) for Skin Wounds
Because the coding and payment landscape for CTPs is ever-changing, the December 2019 Business Briefs column thoroughly reviewed all the changes that occurred throughout 2019 pertinent to CTPs. This author reminded stakeholders to watch for new CTP code assignments and for new outpatient prospective payment system (OPPS) packaging assignments in 2020.
Surprise! For the first time in many years, the Centers for Medicare & Medicaid Services (CMS) did not assign any new CTP codes or make any CTP code description changes in January 2020. Of course, the CMS could release new CTP code assignments in April, July, or October 2020.
The CMS did reassign one CTP from the low cost to the high cost OPPS package: Q4208 Novafix, per sq cm. All the other information provided in the December 2019 column remains the same as of January 1, 2020.
Autologous Soft Tissue and Fat Grafting
The American Medical Association (AMA) released 5 new codes and guidelines that may be of interest to some wound/ulcer management physicians and other qualified healthcare professionals (QHPs). The first new code, 15769, is for reporting autologous soft tissue grafting, such as fat, dermis, fascia, or other soft tissues that are harvested (using an excisional technique) from the patient and placed into a defect for reconstructive purposes. The other 4 new codes, 15771–15774, are for reporting autologous fat grafting when the adipose cells are harvested (using a liposuction technique), from the patient and injected via a cannula in small aliquots to the defect. If your clinical team plans to perform these procedures, carefully read the AMA’s definition of each code, and the very specific guidelines for each code’s use. Then share that information with your clinical and revenue cycle teams so their documentation, coding, charging, and claim submission are correct when these procedures are performed.
Spatial Frequency Domain Imaging (SFDI) Revenue Cycle Processes
This author has received many questions from physician offices and hospital owned outpatient wound/ulcer management provider-based departments (PBDs) who wonder if they can report and bill for spatial frequency domain imaging (SFDI) because the AMA granted it a Proprietary Laboratory Analyses (PLA) code: 0061U. To answer the questions, this author first researched the definition of the code: 0061U Transcutaneous measurement of five biomarkers (tissue oxygenation (StO2), oxyhemoglobin (ctHbO2), deoxyhemoglobin (ctHbR), papillary and reticular dermal hemoglobin concentrations (ctHb1 and ctHb2), using spatial frequency domain imaging (SFDI) and multi-spectral analyses.
Then this author researched the technology that stimulated the creation of the code 0061U and learned that the Clarifi™ Imaging System (Modulim) is the only FDA-cleared microvascular assessment tool powered by Spatial Frequency Domain Imaging (SFDI). Clarifi quantifies and maps oxygenation and perfusion providing five critical hemoglobin biomarkers associated with microvascular function in tissue. Clarifi helps clinicians assess circulatory status, and elevate and direct patient care to reduce complications and prevent amputations. Once this author understood the new point-of-care diagnostic imaging system, it became clear why physician offices and PBDs wanted to use it during patient encounters.
The next research step was to determine whether 0061U is considered a laboratory test under the Clinical Laboratory Improvement Amendments (CLIA) edits. If it is, the physician offices and PBDs are required to have a CLIA certificate of registration, a CLIA certificate of compliance, or a CLIA certificate of accreditation in order to perform and bill for the diagnostic test. If 0061U is excluded from the CLIA edits, physician offices and PBDs are not required to have any CLIA certificate to perform and bill for taking the diagnostic images. The Medicare Learning Network (MLN) Matters article number MM11135 entitled Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits provided the answer that physician offices and PBDs were hoping to receive.1 The SFDI code 0061U is excluded from CLIA edits and does not require physician offices and PBDs to have a CLIA certificate of any type.
Next, this author researched the 2020 Medicare payment rate, which is listed on the Clinical Laboratory Fee Schedule (CLFS), for 0061U. The 2020 CLFS Medicare allowable rate is $25.10 per image. Because reimbursement is composed of 3 parts (coding, payment, and coverage), the final step of the research was to investigate if any Medicare local coverage determinations (LCDs) or private payer medical policies restrict use of 0061U. This author could not find any LCDs or medical policies pertaining to SFDI. When speaking to some professionals who use SFDI, this author learned that the Medicare Administrative Contractors (MACs) sometimes get confused and deny 0061U when they see the place of service on the claim is a physician office or a PBD. However, the professionals reported they are usually able to reverse the payer’s denial when they prove that 0061U is exempt from the CLIA edits.
Just because this author did not find any pertinent LCDs or medical policies does not mean that 1) some payers do not have a policy, and/or 2) some MACs or private payers will not write a pertinent LCD/medical policy in the future. Therefore, before performing SFDI, wound/ulcer management stakeholders should verify if the imaging will be covered by each patient’s payer.
Now that we know that a code exits for reporting SFDI, that the code is CLIA exempt, and that the code has a published rate on the 2020 Medicare CLFS, physician offices and PBDs can begin adding SFDI to their wound/ulcer management toolboxes. But before you do, take time to educate your clinical and revenue cycle teams about the technology and its correct code.
Non-Contact Real-Time Fluorescence Wound Imaging
This author has also received many questions from wound/ulcer management professionals who want to add non-contact real-time fluorescence wound imaging to their diagnostic toolboxes. The professionals who submitted the reimbursement questions seemed sure that the AMA released new Category III codes for the technology, but they could not find the codes in the 2020 CPT® Manual.
As you probably guessed, this author was challenged to find the answer to these recurring questions. The research began by reviewing information about the technology that stimulated the request for a Category III code. After learning that a real-time handheld fluorescence imaging device (the i:X Imaging Device, MolecuLight) provides instant visualization of bacterial fluorescence which guides the wound/ulcer management professional’s wound bed preparation and choice of treatment, this author understood why the wound/ulcer management professionals were anxious to have a code for this diagnostic wound imaging.
When this author first began researching if a Category III code existed for non-contact real-time fluorescence wound imaging, she could only locate a document that listed a variety of coding options using several unlisted procedure codes and several device codes, but no Category III codes! After further research, this author found several news releases which implied that the new Category III codes, for use of the MolecuLight device, were created at the September 2019 CPT Editorial Panel meeting. According to the normal CPT production cycle, codes created in September 2019 are typically published in the 2021 CPT® Manual, with the exception of Category III codes. According to the AMA’s policy to release Category III codes early, new Category III codes created in September 2019 should be posted on the AMA website by January 1, 2020.
Therefore, this author began monitoring the AMA website in mid-December 2019. As expected, on December 30, 2019, the new Category III codes were published on the AMA website. Then this author found an update to the Category III coding information on January 6, 2020. All the Category III codes released on December 30, 2019 will be effective July 1, 2020 and will be published in the 2021 CPT® Manual. The new Category III codes for the non-contact real-time fluorescence wound imaging will be 0598T and 0599T. Your clinical and revenue cycle teams can find the description of these and other new Category III codes on the AMA Website.2
Your clinical and revenue cycle teams should be reminded that Category III codes are temporary codes that allow clinical efficacy, utilization, and outcome data collection for emerging technology. The goal is to prove that the emerging technology has widespread usage to validate converting the Category III codes to Category I codes. Therefore, if this new non-contact real-time fluorescence wound imaging is important to your wound/ulcer management business and you believe it warrants Category I codes, you should report the new Category III codes after they become effective on July 1, 2020. In fact, once the Category III codes are available, those codes must be reported instead of the Category I unlisted codes that you may have been reporting prior to July 1, 2020. Because the Category III codes are not assigned relative value units, they do not have published allowable rates on the Medicare fee schedules. Therefore, payment rates will be determined by each payer.
In addition, coverage for these Category III codes will be based on the policies of the individual payers. Wound/ulcer management professionals should take this opportunity to educate the payers why this technology assists you to provide the right care to the patient, at the right price, and with the right outcomes.
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 firstname.lastname@example.org.
1.Centers for Medicare and Medicaid Services. Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits. Available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11135.pdf. Last accessed January 17, 2020.
2. American Medical Association. CPT Category III Codes. Available at https://www.ama-assn.org/system/files/2020-01/cpt-category3-codes-long-descriptors.pdf . Last accessed January 19, 2020.