The Ever-Changing Reimbursement Landscape of CTPs for Skin Wounds

Twenty years ago, when this author began consulting with manufacturers of cellular- and/or tissue-based products (CTPs) for skin wounds, only 4 CTPs were on the market. When 2019 began, the Centers for Medicare & Medicaid Services (CMS) had assigned HCPCS codes to 121 CTPs. By the end of 2019, the number of CTPs assigned HCPCS codes had grown to 150. When the CMS releases the 2020 HCPCS codes, the number of CTPs assigned HCPCS codes will most likely increase again.  

This explosion of available CTPs provides a wide variety of clinical options for the wound/ulcer management professionals. However, keeping up with the new products, their new codes, and the ever-changing Medicare payment systems for CTPs is a challenge for all members of the revenue cycle team. Even though the HCPCS codes for CTPs are used by both hospital-owned outpatient provider-based departments (PBDs) and physicians/other qualified healthcare professionals (QHPs) in their offices, Medicare reimbursement for the CTPs in each site of care is quite different and continues to evolve. Therefore, the information in this article should serve as an audit guide to check the CTP coding and billing revenue cycle in PBDs and physician/QHP offices. 

Medicare Reimbursement of CTPs in PBDs 

PBDs receive a packaged Medicare payment for both the CTP and its application. The CMS assigns CTPs to either a high-cost or a low-cost outpatient prospective payment system (OPPS) package. If a CTP is assigned to the high-cost package, the PBDs report, on their Medicare claims, the HCPCS code of the CTP and the correct procedure code (15271–15278) for applying high-cost CTPs. If a CTP is assigned to the low-cost package, the PBDs report, on their Medicare claims, the HCPCS code of the CTP and the correct procedure code (C5271–C5278) for applying low-cost CTPs.

NOTE: Based on updated pricing information received throughout the year, the CMS can reassign a CTP to a different OPPS package. Therefore, PBDs must review the quarterly OPPS updates and revise their charging systems to align with packaging updates that apply to CTPs they use.  

The only CTPs that may receive a separate OPPS payment, for both the product and its application, are CTPs that have achieved pass-through status. In 2019, only 2 CTPs have pass-through status: Q4195 PuraPly (Organogenesis) and Q4196 PuraPly AM (Organogenesis). If the pass-through CTP’s allowable rate exceeds the dollar amount that is built into the OPPS packaged payment rate for the procedure (called the device offset), the PBD receives both the packaged procedure payment and a separate payment equal to  the difference between the device offset amount and the allowable rate for the size of product applied. If the pass-through CTP’s allowable rate is equal-to or less-than the device offset amount, the PBD only receives the OPPS payment for the packaged procedure. The 2019 device offset amounts for the 2 Ambulatory Payment Classification (APC) groups aligned with the packaged CTP application procedures are:

• APC 05054 $737.11

• APC 05055 $185.54 

See Table 1 for the CTP codes, OPPS packaged payment, and pass-through status  assignments that were effective on January 1, 2019.  

Based on updated pricing information, in April 2019 the CMS reassigned 4 CTPs from the low-cost to the high-cost OPPS payment package. See Table 2 for these April 1, 2019 reassignments.

Based on updated pricing information, in July 2019 the CMS reassigned 1 CTP from the low-cost to the high-cost OPPS payment package. See Table 3 for the July 1, 2019 reassignment.

Then, effective October 1, 2019, the CMS assigned new HCPCS codes to 18 additional CTPs. Please note that because some of these products are flowable or powders, they are not eligible to be reported with the application codes for CTPs and are not assigned to an OPPS payment package. See Table 4 for the October 1, 2019 new HCPCS codes and OPPS payment package assignments for the new CTPs. Also effective on October 1, 2019, three CTPs’ code descriptions were revised. See Table 5 for the CTP code description changes.

On November 1, 2019 the OPPS Final Rule for 2020 was released. All the high-cost and low-cost OPPS package assignments remained the same for 2020, except for one CTP. See Table 6 for the January 1, 2020 OPPS package reassignment.

NOTE: Watch for new HCPCS code and OPPS packaging assignments for new CTPs in the 2020 updates that will be released by the CMS on a quarterly basis.

The 2020 OPPS Final Rule reminds PBDs that the pass-through status for PuraPly and PuraPly AM is still effective from January 1, 2020 through September 30, 2020. On October 1, 2020, both PuraPly and PuraPly AM will be packaged into the OPPS packaged payments. The Final Rule also informs the PBDs that the 2020 device offset amounts will increase on January 1, 2020 to:

• APC 05054 $759.52

• APC 05055 $269.41

IMPORTANT REMINDER FROM AUTHOR: Although the CMS maintained the high-cost and low-cost packaged CTP payment methodology in the 2020 OPPS Final Rule, they indicated their intent to change the payment methodology for the use of CTPs in the future. No matter whether the CMS uses an episodic payment, a single payment, or some other methodology, PBDs can be sure the allowable payment rate(s) will be based on claims data submitted for the previous 2 years. Therefore, every PBD in the country should take the time to audit their CTP claims to be sure the correct HCPCS code, the correct number of sq cm purchased, and the correct marked-up charge (based on the hospital’s cost-to-charge ratio) appears on every claim along with the correct procedure code for the application of either a high-cost or a low-cost CTP. If the CTP claims are not correct, the PBD should work with their entire revenue cycle team to correct the errors in the system so all claims for CTPs are correct in 2020. Do not put off this very important task. Because every PBD’s claims data will be used to determine the future OPPS payment methodology for CTPs, every claim for CTPs should provide the correct “picture” to the CMS. 

The 2020 OPPS Final Rule provides a small payment increase for the packaged CTP allowable rates. See Table 7 for a comparison of the 2019 and 2020 national average allowable OPPS payment rates for the application of both high-cost and low-cost CTPs. 

Medicare Reimbursement of CTPs in Offices of Physicians and QHPs

Physician/QHP offices receive separate payments for both the CTP and its application. Unlike the PBDs, the offices also receive additional payments for the add-on procedure codes. The Medicare payment rate for the CTP is based on either its published average sales price (ASP) or its invoice price. Even though most of the CTP manufacturers report their ASPs on a quarterly basis, the CMS does not publish all the ASPs that are reported. See Table 8 for the ASPs that the CMS published each quarter of 2019. 

When the CMS does not publish the ASP for a CTP that is covered by the Medicare Administrative Contractor (MAC), the physician/QHP office should include the following information in block 19 of a paper claim, or in the narrative record of the electronic claim:

• CTP name

• CTP size

• CTP product number

• Invoice price per piece

• Shipping cost

Two MACs recently released instructions that require offices to report invoice prices on claims for all CTPs.

1. First Coast Service Options requires offices to obtain and report the total invoice amount (not the retail amount or amount charged) for the CTP used for the patient. The invoice amount should be reported in the following format: INV. $00.00. The invoice amount should be entered in block 19 of the CMS-1500 paper claim form or its equivalent of Loop 2400 Segment NTE02. If the invoice amount is not listed appropriately on the claim, or if the information is missing, First Coast Service Options will send an Additional Documentation Request (ADR), which will request the invoice. This ADR will hold up processing of the claim. 

2. Noridian Healthcare Solutions requires the offices to report the amount they paid for the CTP as indicated on the invoice for the specific CTP used for the patient. The physician/QHP office must maintain a copy of the invoice in the patient’s file, which must be made available to Noridian upon request. The invoice price must be reported in the following manner:

For paper claim submission: 

•Enter the procedure code and invoice price, for each Q code, in Item 19 of CMS-1500 claim form

•Enter the number of units in Item 24G of CMS-1500 claim form

For electronic submission:

•Enter the procedure code and invoice price, for each Q code, in loop 2400/SV101-7

•Enter the number of units in “quantity billed” column

If physician/QHPs apply CTPs in their office and have received denials for CTPs that they believe are covered by the MAC, take a few minutes to audit the paper or electronic claims to see if the invoice prices were reported correctly. 

On November 1, 2019 the Medicare Physician Fee Schedule Final Rule for 2020 was released. The relative value units (RVUs) assigned to most of the procedure codes for the application of CTPs increased slightly. See Table 8 for a comparison of the 2019 and 2020 RVUs for work performed in the office (non-facility) and work performed in facilities. n

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.