Alphabet Soup of Codes for CTPs [Skin Substitutes] for Skin Wounds

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As a reimbursement strategy and education consultant, this author always attempts to explain the reimbursement “who?” “what?” and “why?” in an easy-to-understand manner. Because readers have submitted many questions about the diverse types of HCPCS codes recently assigned to cellular- and/or tissue-based products (CTPs) for skin wounds [outdated term “skin substitute”], this article will address the “who?” and “what?” However, the article will not address the “why?” because the Centers for Medicare & Medicaid Services (CMS) have not explained “why” they assigned diverse types of HCPCS codes to the CTPs. Let us review the recent HCPCS coding assignments that have created this alphabet soup of CTP codes.

HCPCS “Q” Codes Typically Assigned to All CTP Categories

On January 1, 2009, the CMS created new HCPCS “Q” codes for each brand of CTP. The code descriptions included the term “skin substitute.”
            Example:       Q4101 Skin substitute, Apligraf, per sq cm

Then on January 1, 2010, the CMS deleted the term “skin substitute” from the code descriptions because the FDA does not permit most manufacturers to call these products “skin substitutes.”
            Example:       Q4101 Apligraf, per sq cm

As of January 1, 2022, the CMS has assigned more than 100 HCPCS “Q” codes to CTPs. The current codes range from Q4101 through Q4258 and have been assigned to all types of CTPs such as cellular, extracellular matrix, and amniotic.

HCPCS Codes for Synthetic CTPs

In 2018, as anticipated, several manufacturers launched synthetic CTPs. When the manufacturers applied for HCPCS “Q” codes, the CMS did not assign HCPCS “Q” codes, like all the other CTPs. Instead, the CMS created 2 HCPCS codes that did not appropriately describe the innovative synthetic skin substitutes: A6460/A6461 synthetic resorbable wound dressing. To further confuse the situation, the CMS assigned these supply codes to the jurisdictions managed by the A/B MACs. Because A/B MACs do not normally separately pay for supply codes in physician and other qualified health care professional (QHP) offices and hospital-owned outpatient wound/ulcer management provider-based departments (PBDs), both sites of care could not afford to purchase the new synthetic CTPs.

Of course, the manufacturers of the synthetic CTPs and the wound/ulcer management professionals who wanted to use the innovative technologies, requested the CMS to assign billable HCPCS “Q” codes to the synthetic CTPs, just like the other skin substitutes.

In the 2021 OPPS Final Rule, the CMS finally agreed with the scientists, manufacturers, and wound/ulcer management professionals that synthetic CTPs were indeed “skin substitutes.” However, the CMS only fixed one-half of the coding problem, and they fixed it in a way that still did not align the coding for synthetic CTPs with the coding for the other CTPs. The CMS created one HCPCS “C” code (C1849 skin substitute, synthetic, resorbable, per square centimeter) to be used by all the synthetic CTPs, rather than a unique HCPCS “Q” code for each synthetic CTP brand. One code for multiple products was problematic for the manufacturers, who had no way to verify that their synthetic CTP qualified to be reported with C1849. One code for multiple products was also problematic for the PBDs because they had no way to prove to the value analysis committee, to the coders and billers, or to the Charge Description Master director that C1849 was the correct code for multiple synthetic CTPs when all other CTPs have unique HCPCS “Q” codes.

In addition, the CMS did not follow their OPPS payment packaging regulation, which is to assign new CTPs to the low-cost package until the manufacturers provide pricing that indicates whether the new CTP should remain in the low-cost package or be moved to the high-cost package. Instead, they used the pricing of one product and immediately assigned C1849 to the high-cost package, which means that the CMS may have been paying the high-cost package payment for products that should be in the low-cost package.

The other reason HCPCS code C1849 only fixed one-half of the synthetic CTP coding problem is because HCPCS “C” codes are only payable in PBDs; they are not payable in physician/QHP offices. Therefore, for the third year in a row, physician/QHP offices still could not apply the new synthetic CTPs. They had to inconvenience the Medicare beneficiaries, who they normally managed in their office, and send them to PBDs for the application of synthetic CTPs.

Therefore, once again, the manufacturers of synthetic CTPs applied for unique HCPCS “Q” codes for their products so that the PBDs and the physician/QHP offices would be able to handle the coding for all CTPs in the same way. Although assigning the unique HCPCS “Q” codes seemed like a logical and consistent solution to all wound/ulcer management stakeholders, the 2022 final Medicare payment rules made the coding for synthetic CTPs even more confusing.

• The 2022 OPPS Final Rule clarified that C1849: 1) should still be used to report all brands of synthetic CTPs applied in PBDs and 2) would remain in the high-cost package.
• The 2022 MPFS Final Rule created unique HCPCS “A” codes for each of the 4 brands of synthetic CTPs (A2002 for Mirragen Advanced Wound Matrix [ETS Wound Care], A2005 for Microlyte Matrix [Imbed Biosciences], A2006 for NovoSorb SynPath [Polynovo], and A2007 for Restrata [Acera Surgical]). Since then, 2 other synthetic CTPs have been assigned HCPCS “A” codes (A2011 for SupraSDRM [PolyMedics Innovations] and A2012 for Suprathel [PolyMedics Innovations]).

In case you are wondering if physician/QHP offices will be separately paid by the A/B MACs for these HCPCS supply “A” codes, you are not alone. The A/B MACs wondered the same thing! In fact, the CMS had to release a directive telling physician/QHP offices that they should report the HCPCS “A” codes on their Medicare claims and telling the A/B Macs that they should process the claims with HCPCS “A” codes. Unfortunately, the CMS did not direct the MACs to pay the physician/QHP offices just like they pay for all other CTPs: ASP +6% (WAC + 3% or 95% of AWP when CTPs are not yet priced on the Medicare Part B Drug Average Sales Price File). Instead, the CMS simply said that the MACs should determine the payment rates for the synthetic CTPs.

Recent HCPCS Code Assignments for Extracellular Matrix and Amniotic CTPs

In case you think this alphabet soup of HCPCS code assignments only happened to the synthetic CTPs, take a few more minutes to read the remainder of this article! When the CMS announced that they were assigning HCPCS “A” codes for the physician/QHP offices to report application of synthetic CTPs, no one could have guessed that the CMS would also assign HCPCS “A” codes to extracellular matrix and amniotic CTPs. But you guessed it: the CMS has now assigned HCPCS “A” codes to 4 extracellular matrix CTPs (A2004 XCelliStem [Systemsys], A2008 TheraGenesis [Misonix], A2009 Symphony [Aroa Biosurgery], and A2010 Apis [Sweetbio]) and 2 amniotic CTPs (A2001 InnovaMatrix AC [Triad Life Sciences] and A2013 InnovaMatrix FS [Triad Life Sciences]) that should have been assigned HCPCS “Q” codes. Physician/QHP offices were instructed to report these HCPCS “A” codes just like they report the synthetic CTP “A” codes. However, for a few months these 6 CTPs could not be applied in PBDs because PBDs could not report HCPCS “A” codes.

If you are like most wound/ulcer management stakeholders, you are most likely saying to yourself: “All of this coding and payment confusion could have been alleviated by the CMS simply assigning unique HCPCS “Q” codes to each brand of CTP, no matter whether it is a cellular, extracellular matrix, amniotic, or synthetic product. In fact, the Alliance of Wound Care Stakeholders and other similar advocacy groups did their best to educate the CMS “why” all the CTPs should be assigned unique HCPCS “Q” codes.

The CMS Made HCPCS “A” Codes Payable in PBDs

On March 24, 2022, the CMS announced that effective April 1, 2022, they were making the HCPCS “A” codes, assigned to synthetic, extracellular matrix, and amniotic products, payable in PBDs. Prior to April 1, 2022, those HCPCS “A” codes had a status indicator of “A” not paid under OPPS; paid by MACs under a fee schedule or payment system other than OPPS. Effective April 1, 2022, the CMS reassigned those HCPCS “A” codes to status indicator “N” paid under OPPS; payment is packaged into payment for other services.

Because these HCPCS “A” codes are now payable in PBDs, the CMS assigned them to the high-cost or low-cost skin substitute group, just like they do for all other new CTPs. Keep in mind that some of these products assigned to the low-cost group may be reassigned to the high-cost group once the manufacturers share their pricing information with the CMS Division of Outpatient Care. Also remember, that the products in the low-cost group should be reported by the PBD on the same claim as the application code(s) for low-cost products C5271–C5278. Likewise, the product in the high-cost group should be reported by the PBD on the same claim as the application code(s) for high-cost products 15271–15278. See Table 1 for the April 1, 2022, low/high-cost skin substitute group assignments.

HCPCS Code for CTPs Not Yet Assigned a Unique Code

Many readers have been inquiring about the new HCPCS code that took effect on April 1, 2022: A4100 skin substitute, FDA cleared as a device, not otherwise specified. The only explanation that the CMS gave for releasing this new code was that it was to “create consistency.” Let us think about the HCPCS code that physician/QHP offices, PBDs, coders, and billers have been successfully using since 2009: Q4100 skin substitute, not otherwise specified. For more than 10 years, when a new CTP was purchased and used before the CMS assigned a brand specific HCPCS “Q” code, Q4100 has worked perfectly.

Unfortunately, the CMS did not provide any direction for when HCPCS code Q4100 and A4100 should be used. Because physician/QHP offices, PBDs, coders, and billers do not distinguish CTPs by their method of FDA market clearance, this author is not sure how they will be able to select the correct code for new CTPs that are awaiting unique HCPCS code assignments. Even though the CMS says that HCPCS code A4100 is to create consistency, it is already creating confusion. We should watch closely for further clarification from the CMS.

Summary

Physician/QHP offices and PBDs should pay close attention to HCPCS code assignments for the various categories of CTPs they purchase and apply. Keep your coders, billers, and Charge Description Master directors informed of the alphabet soup of HCPCS codes that cause the various categories of CTPs to be coded differently in physician /QHP offices and PBDs. If you believe that the CMS should consistently assign unique HCPCS “Q” codes to all CTPs, take the time to educate the Contractor Advisory Committee members in your Medicare Jurisdiction, as well as your MAC medical director.

Finally, lend your support to the various advocacy groups who work hard to educate the CMS about matters such as this that are so important to your patients and to you, the wound/ulcer management professionals.
 
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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