Are You Prepared to Implement the 2023 CTP Final Rules?

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.
 
Ever since July, when the 2023 Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) Draft Rules were released, wound/ulcer management stakeholders across the country have been confused and concerned about the proposed coding and payment changes for cellular- and/or tissue-based products for skin wound (CTPs) and their application. Because the application of CTPs is one of the important procedures available for patients with chronic non-healing ulcers that fail to heal with standard of care, many wound/ulcer management professionals, manufacturers, medical societies, advocacy groups, and congressmen provided comments to CMS with hopes that the coding and payment proposals in the draft rules would not be finalized in the 2023 OPPS and MPFS Final Rules.

Now that the 2023 OPPS and MPFS Final Rules have been released, wound/ulcer management physicians, qualified healthcare professionals (QHPs), and hospital owned outpatient provider-based departments (PBDs) have been asking exactly what the rules mean to the purchase of, and application of, CTPs beginning January 1, 2023. The most frequently asked questions and answers are provided in hopes that they will help you implement the 2023 CTP final rules.  

CTP Coding Questions

Q:       In the April Business Briefs column, you explained 1) that CMS created one HCPCS code, C1849 skin substitute, resorbable, per square centimeter, for PBDs to report all the synthetic CTPs, 2) that CMS created HCPCS “A” codes for physician/QHP offices to report the use of synthetic CTPs, and 3) that CMS announced that the HCPCS “A” codes should also be reported by PBDs. In the July Business Briefs column, you shared the new CTPs that were assigned HCPCS “A” codes and HCPCS “Q” codes in April and July. These CMS coding decisions have caused much confusion for physician/QHP offices and for PBDs.  

The coders and billers for physician/QHP offices often tell their professionals not to use synthetic CTPs because the coders and billers believe that HCPCS “A” codes are not separately payable in offices by Medicare and most other payers. In addition, because HCPCS code C1849 is still an active code, coders and billers for PBDs think they should continue to report it, rather than the HCPCS “A” codes. Did the 2023 OPPS and/or MPFS Final Rule(s) clarify the coding for synthetic CTPs in physician/QHP offices and in PBDs?

A:        As described in the April Business Briefs column, CMS released a directive 1) telling physician/QHP offices that they should report the HCPCS “A” codes in the A2XXX series on their Medicare claims and 2) telling the A/B Medicare Administrative Contractors (MACs) that they should process the claims with HCPCS “A” codes.

TO DO: Physician/QHP offices should have already added the HCPCS “A” codes, for synthetic CTPs they plan to purchase, to their charge sheets, to their electronic health records, and to their billing software.        

In addition, when CMS first created the HCPCS “A” codes, they were assigned the OPPS status indicator “A” not paid under OPPS; paid by MACs under a fee schedule or payment system other than OPPS. That made sense because CMS had already created HCPCS code C1849 for PBDs to report synthetic CTPs. Then CMS changed the HCPCS “A” codes’ OPPS status indicator to “N” paid under OPPS payment; payment is packaged into payment for other services. That new status indicator also allowed synthetic CTPs reported with the new HCPCS “A” codes to be included in the OPPS packaged payment system. Because CMS did not retire HCPCS code C1849 when the HCPCS “A” codes were activated in PBDs, the PBDs were confused by the directives to use 2 different codes to report the use of synthetic CTPs.  

Thankfully, the 2023 OPPS Final Rule announced that HCPCS code C1849 will be retired on December 31, 2022, and that PBDs should report the HCPCS “A” codes assigned to the synthetic CTPs.

TO DO: Now that PBDs finally have clear coding direction for synthetic CTPs, PBDs should: 1) remove HCPCS code C1849 from their electronic health record, their Charge Description Master, and their coding and billing software; and 2) add, to the same systems, the HCPCS “A” codes for synthetic CTPs that the physicians/QHPs plan to apply in the PBD. 

Q:       Our coders and billers do not believe us when we tell them that some extracellular matrix CTPs and some amniotic CTPs have been assigned HCPCS “Q” codes and others have been assigned HCPCS “A” codes. Did the 2023 OPPS and/or MPFS Final Rules add any clarity to this confusing coding issue?

A:        Yes, CMS explained that starting in January 2022, they began assigning product-specific HCPCS “A” codes in the A2XXX series to CTPs: both biological products (that are not human cell, tissue, or cellular or tissue-based products [HCT/Ps]) and synthetic products with FDA 510(k) clearance. In other words, effective January 2022, CTPs with an FDA 510(k) clearance were no longer assigned product specific HCPCS “Q” codes.

This means that older biological products are currently assigned HCPCS “Q” codes, while newer biological products and synthetic products are currently assigned HCPCS “A” codes in the A2XXX series. The HCT/Ps are still assigned HCPCS “Q” codes. In fact, the following HCT/Ps met all the criteria for use as a barrier or cover under section 361 of the Public Health Service (PHS) Act and the regulations in 21 CFR part 1271 and were assigned HCPCS “Q” codes that will become effective January 1, 2023:

Q4236            carePATCH^™, per square centimeter     
Q4262            Dual Layer Impax^™ Membrane, per square centimeter          
Q4263            SurGraft^® TL, per square centimeter
Q4264            Cocoon Membrane, per square centimeter
 
TO DO: PBDs and physician/QHP offices should verify that their electronic health record, their charging system, and their coding and billing software are updated with the correct HCPCS codes for the CTPs that they use.

Q:       I am a physician who provides wound/ulcer management services to patients who are homebound and who are typically also receiving care from a home health agency. I have been applying several of the new synthetic CTPs to these patients. My coder just informed me that some synthetic CTP codes have been added to the Home Health Agency Consolidated Billing (CB) List. Is this true? If so, which synthetic CTPs are on the CB list?

A:        Effective, January 3, 2023, CMS will add the following codes to the Home Health Agency CB non-routine supply code list:
A2014            Omeza collagen matrix per 100 mg
A2015            Phoenix wound matrix, per square centimeter
A2016            Permeaderm b, per square centimeter
A2017            Permeaderm glove, each
A2018            Permeaderm c, per square centimeter
 
Because no other CTPs with HCPCS “A” or “Q” codes are on the Home Health Agency CB non-routine supply code list, this author does not understand why these five CTPs were included on the list.
 
TO DO: Physicians/QHPs should discuss this issue with the MAC that processes their claims.
 
Q:       Our coders and billers say that the CTP application codes are only covered and payable by Medicare when CTPs in the sheet form are applied and fixated. Yet, manufacturers of other forms of CTPs such as gels and powders, assure us that their products are assigned HCPCS codes. Who should we believe? Will Medicare pay the PBD or our office if we apply CTPs that are not in sheet form?

A:        When CMS discusses new or changed HCPCS codes, they always remind stakeholders that the existence of a code does not guarantee payment or coverage. In fact, CMS often assigns codes for products that are not covered or paid for by the Medicare program. That is the case for some CTPs. In the CPT^® codebook, the American Medical Association’s CPT^® Editorial Panel makes it very clear that the CTP application codes should not be reported for applying gels, powders, ointments, foam, liquids, or injected CTPs.

In the 2023 OPPS Final Rule, CMS clarified that they are following the AMA’s guidelines when they said: “We interpret the term ‘skin substitute graft’ to mean the application of sheet skin substitute products that would be grafted in the wound area. A powder is not a graft even if the product forms a sheet scaffolding similar to a skin substitute product. If a skin substitute product is not a sheet product, then it is not described by the skin substitute graft application codes, and the product cannot be assigned to the high cost or low cost skin substitute groups.”

TO DO: If physicians/QHPs determine that a CTP form, other than a sheet, is medically necessary for a Medicare patient, they should 1) discuss the need with the patient and, 2) inform the patient that she/he will be financially responsible for the application and the product because neither are covered by Medicare.

CTP Payment Questions

Q:       For 2023, did CMS make any changes to the way they assign CTPs to the high-cost or low-cost CTP groups that are pertinent to PBD Medicare payment?

A:        No, CMS maintained the same methodologies for determining if CTPs should be assigned to the high-cost or low-cost CTP groups. In addition, CMS confirmed that any CTP that was assigned to the high-cost group in CY 2022 would be assigned to the high-cost group for CY 2023, regardless of whether it exceeds or falls below the CY 2023 geometric mean unit cost (MUC) or per day cost (PDC) threshold. The CY 2022 MUC was $48.00 per sq. cm. and decreased to $47.00 per sq. cm in CY 2023. The CY PDC was $949.00 per sq. cm and decreased to $837.00 per sq. cm in CY 2023.
 
The 2023 OPPS Final Rule clarified the CTP group assignment regulation that has existed for several years: “New skin substitutes without pricing information will be assigned to the low-cost category until pricing information is available through pricing compendia to compare to the CY 2023 MUC and PDC thresholds.”
 
CMS also clarified that the new HCPCS code A4100 Skin substitute, FDA cleared as a device, not otherwise specified is assigned to the low-cost group, which is consistent with their existing payment policy.
 
CMS did make one surprising CTP group assignment announcement that pertains to synthetic CTPs used in PBDs. In the 2023 OPPS Final Rule CMS made an exception to their own CTP group assignment rule: “… any graft skin substitute product that is currently assigned a product-specific code in the HCPCS A2XXX series and is appropriately described by HCPCS code C1849 or is assigned a product-specific code in the HCPCS A2XXX series in the future and is appropriately described by HCPCS code C1849 [will] be assigned to the high-cost skin substitute group. In addition, [effective January 1, 2023] any graft skin substitute product that is assigned a code in the HCPCS A2XXX series in the future will be assigned to the high-cost skin substitute group.”
 
Now that you know CMS’s logic for assigning CTPs to high-cost or low-cost groups, you are probably asking: “Where can I find a list of which CTPs are assigned to the high-cost and low-cost CTP categories?” Luckily, Table 62 in the 2023 OPPS Final Rule clearly shows the high-cost and low-cost CTP group assignments for 2022 and for 2023.
 
TO DO: Because the CTP group assignments determine whether PBDs should report the codes 15271–15278 for the application of high-cost CTPs or the codes C5271–C5278 for the application of low-cost CTPs, all PBD wound/ulcer management professionals and revenue cycle partners should carefully review pages 607–610 of Table 62 (also included in PDF). They should then make any needed changes in their electronic health record, their Charge Description Master, and their coding and billing software.
 
Q:       Will you please tell me the 2023 OPPS National Average Allowable rates for the application of CTP codes 15271–15278 and C5271–C5278? Are the 2023 rates an increase or decrease over the 2022 rates?
 
A:        The comparison of the 2022 vs. 2023 OPPS national average allowable rates is in the table here. Please note that some of the rates increased while others decreased.
 
TO DO: Keep in mind that the rates in the table are national average rates. PBDs should verify their facility-specific rates with their finance office.
           
Q:       For 2023, did CMS change the way they pay physician/QHP offices for CTPs and their application? I heard that the payment for the product was packaged into the payment for the CTP application. Is that true?
 
A:        No, for 2023 CMS did not change the way they pay physician/QHP offices for CTPs and their application. Yes, it is true that CMS proposed packaging the payment for the product into the payment for the application but decided to postpone that decision. Instead, early in 2023 CMS plans to facilitate a Town Hall Meeting to discuss coding, payment, and coverage issues pertaining to CTPs.  
 
TO DO: Wound/ulcer management professionals should plan to attend the Town Hall Meeting. They should educate CMS about the clinical evidence, appropriate utilization guidelines, the need for consistent coding, and the need for separate payment for CTPs and for the work to apply the CTPs
 
Q:       I understand that the 2023 MPFS allowable rates have decreased. Will you please provide a comparison of the 2022 vs. 2023 rates when a physician performs the work in the office and in a PBD?
 
A:        The comparison of the 2022 vs. 2023 MPFS national average allowable rates is in the table here.
 
TO DO: Keep in mind that these are national average rates. Physicians/QHPs should visit their MAC’s website to view the exact 2023 rates for their state.
           
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@gmail.com.      

Click here for a PDF of this article.