Many readers have been asking questions about the 2016 Medicare outpatient prospective payment system (OPPS) coding, payment, and coverage of cellular and/or tissue-based products for wounds (CTPs; outdated term "skin substitute"). I have gathered all the readers' questions on this topic and will provide the answers. As a reminder, please continue to send questions that you would like to see answered in this column.
Q: Did any new CTPs receive Healthcare Common Procedure Coding System (HCPCS) codes for 2016?
A: Yes, several new CTPs were assigned HCPCS codes effective January 1, 2016.
Q4161 BIO-CONNEKT Wound Matrix, per square centimeter
Q4162 AMNIOPRO Flow, BIOSKIN Flow, BIORENEW Flow, WOUNDEX Flow, AMNIOGEN-A, AMNIOGEN-C, 0.5 mL
Q4163 AMNIOPRO, BIOSKIN, BIORENEW, WOUNDEX, AMNIOGEN-45, AMNIOGEN-200, per square centimeter
Q4164 HELICOLL, per square centimeter
Q4165 KERAMATRIX, per square centimeter
Q: I am confused by the 2016 descriptions for HCPCS codes C9349 and Q4153. Did their descriptions change from 2015?
A: Yes, their descriptions did change. See Table 1. If you use those products, be sure to update your charge sheets and/or your Charge Description Masters (CDMs).
Q: Are the CTPs still packaged into the OPPS payment for the associated CTP application procedure?
A: Yes, the CTPs that do not qualify for OPPS pass-through status are packaged into the OPPS payment for the associated CTP application procedure. For OPPS packaging purposes, the CTPs are divided into 2 groups: (1) "high-cost" CTPs and (2) "low-cost" CTPs. Table 2 lists the CTP products assigned to the high-cost group in 2015 versus 2016, and Table 3 lists the CTP products assigned to the low-cost group in 2015 versus 2016.
For Medicare billing, high-cost CTPs should be reported in combination with the performance of one of the CTP application procedures described by CPT(R)* codes 15271-15278. For Medicare billing, low-cost CTPs should be reported in combination with the performance of one of the CTP application procedures described by HCPCS codes C5271-C5278.
Q: What are the packaged 2016 OPPS payment rates for the application of high-cost and low-cost CTPs?
A:Table 4 displays the changes, from 2015 to 2016, of OPPS payment rates for high-cost CTPs. Table 5 displays the changes, from 2015 to 2016, of OPPS payment rates for low-cost CTPs.
Many readers know that I keep reminding the hospital-based outpatient wound care departments (HOPDs) to check their CDM charges for the application of CTPs to wounds equal to or greater than 100 sq cm. Here's the reason why: The OPPS charges submitted to Medicare in 2013 set the OPPS national average allowable rates for 2015, and the 2014 OPPS charges submitted to Medicare in 2014 set the OPPS national average allowable rates for 2016. Please note that in 2013 HOPDs charged more for high-cost CTPs applied to wounds equal to or greater than 100 sq cm on the trunk, arms, and legs (15273) than they did for the same-size wounds on smaller anatomic locations such as the feet (15277). This made no sense to me because the HOPDs had to purchase the same amount of product for wounds equal to or greater than 100 sq cm-no matter what anatomic location was receiving the CTP application. This huge CDM error caused the 2015 OPPS rates for 15273 and 15277 to be widely different.
Some HOPDs corrected that CDM error in 2014, which caused the 2016 rates to be identical for 15273 and 15277. However, HOPDs should carefully examine their 2016 CDM charges for application of high-cost CTPs to large wounds. Ask yourself, "How much will the HOPD have to pay for the high-cost CTP that the HOPD uses for wounds equal to or greater than 100 sq cm?" You may find that your HOPD needs to increase your CDM charges for 15273 and 15277. Remember, your 2016 charges are setting your 2018 OPPS allowable rates.
A similar situation occurred for low-cost CTPs applied to wounds equal to or greater than 100 sq cm. In 2013, HOPDs charged more for low-cost CTPs applied to wounds equal to or greater than 100 sq cm on the trunk, arms, and legs (C5273) than they did for the same-size wounds on the smaller anatomic locations such as the feet (C5277). This made no sense to me because the HOPDs had to purchase the same mount of product for wounds equal to or greater than 100 sq cm-no matter what anatomic location was receiving the CTP application. This huge CDM error caused the 2015 OPPS rates for C5273 and C5277 to be widely different.
Some HOPDs corrected that CDM error in 2014, which caused the 2016 rates to increase for both C5273 and C5277. But they did not increase their charges for both codes at the same rate, which again makes no sense to me. Therefore, HOPDs should carefully examine their 2016 CDM charges for these large wounds on all anatomic locations. Ask yourself, "How much will the HOPD have to pay for the low-cost CTP that the HOPD uses for wounds equal to or greater than 100 sq cm?" You may find that your HOPD needs to increase your CDM charges for both C5273 and C5277. Most important, you should examine the HOPD's charges for C5277 because the allowable rates are still considerably less than they are for C5273. Remember, your 2016 charges are setting your 2018 OPPS allowable rates.
Q: Do any CTPs have OPPS pass-through payment status for 2016?
A: Yes, only 3 products have OPPS pass-through status for 2016. See Table 6. All CTPs with OPPS pass-through status should be reported to Medicare in combination with one of the CTP application procedures described by CPT codes 15271-15278.
Keep in mind that HOPDs receive additional payment for a product with pass-through status only if the product cost exceeds the dollar value that CMS allocated for the device offset in the procedure allowable rate. In 2016, $511.00 is allocated toward the device offset for pass-through status products applied to wounds less than 100 sq cm, and $139.36 is allocated toward the device offset for pass-through status products applied to wounds equal to or greater than 100 sq cm. Because many wounds managed in HOPDs are small, the device offset cost may not be exceeded.
Q: With the plethora of CTPs on the market, our HOPD has been inundated with sales representatives telling us that their products now have codes and are automatically covered by Medicare. Is that true?
A: No, that is not true. Here is what Medicare tells us: "The fact that a drug, device, procedure, or service is assigned an HCPCS code and a payment rate under the OPPS payment system does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program. Medicare Administrative Contractors (MACs) determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it is reasonable and necessary to treat the beneficiary's condition and whether it is excluded from payment."
Therefore, it is imperative that HOPDs and qualified healthcare professionals review their MAC's current local coverage determination (LCD) (if one exists) that pertains to CTPs. See Table 7 for a list of the MACs that released LCDs pertaining to CTPs effective March 2, 2016. Remember, on a monthly basis, check your MAC's LCDs for revisions. The absence of an LCD also does not mean that all the CTPs will be covered. It simply means that the MAC is going to determine coverage claim-by-claim based on medical necessity.
*CPT is a registered trademark of the American Medical Association.