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CTPs Continue to Make the News!
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This author did not plan to write about cellular and/or tissue-based products (CTPs) for skin wounds in April, May, and again in June. However, CTPs continue to make the news. The following are the CTP news highlights that should interest wound/ulcer management manufacturers and professionals.
Office of Inspector General (OIG) Reported About Average Sales Prices
The Consolidation Appropriations Act 2021 requires manufacturers of skin substitutes (CTPs), and other Part B–covered products, to report their average sales prices (ASP) to Centers for Medicare and Medicaid Services (CMS) beginning the first quarter of 2022. Because manufacturers of nearly half of the CTPs in the Office of the Inspector General (OIG) study did not report the required ASP data, CMS was not able to calculate ASP-based payment amounts for those products in the first quarter of 2023.
The OIG concluded that CMS and Medicare beneficiaries overpay tens of millions of dollars every quarter when the Medicare Administrative Contractors (MACs) pay for CTPs based on wholesale acquisition costs or invoices, rather than ASPs. The OIG further concluded that providers are potentially incentivized to purchase CTPs without ASP-based payment because the spread between reimbursement and their cost is greater for those CTPs.
The OIG made it very clear that it expects CTP manufacturers to report their ASPs every quarter, and that it expects CMS to address the unique hurdles they face in implementing ASP-based payments for CTPs.
The FDA Announced Registration Removal of Some 361 HCT/P Manufacturers
The Food and Drug Administration (FDA) requires manufacturers of 361 human cells, tissues, or cellular or tissue-based products (361 HCT/Ps) to register and list their 361 HCT/Ps with FDA’s Center for Biologics Evaluation and Research (CBER) by using the electronic registration and listing system. Within 5 days after beginning operations, establishments that manufacture 361 HCT/Ps must register and submit a list of every 361 HCT/P that they manufacture. Then those manufacturers must update their registration 1) every year in December even if there are no changes or updates to their information, and 2) when changes occur at the time of the change, or each June or December, whichever month occurs first. Additionally, other changes must be reported within 30 calendar days:
- Ownership or location of the establishment
- Establishment’s U.S. agent’s name, address, telephone number, or email address
All 361 HCT/P establishments that failed to submit their annual registration during the previous update period between November 15 and December 31, 2022, should expect that FDA will inactivate their establishment’s registration in the fall of 2023. Thereafter, the FDA will inactivate the establishment’s registration every January if the manufacturer fails to register during the annual registration period.
Because certain voluntary healthcare accreditation organizations require hospitals or surgical centers to annually confirm that their tissue suppliers are registered with the FDA, these facilities will be forced to cease use of CTPs whose manufacturers are not registered with the FDA.
CMS Assigned More HCPCS “Q” Codes
Effective July 1, 2023, 9 new CTPs are assigned HCPCS “Q” codes:
Q4272 Esano™ A, per sq. cm.
Q4273 Esano™ AAA, per sq. cm.
Q4274 Esano™ AC, per sq. cm.
Q4275 Esano™ ACA, per sq. cm.
Q4276 Orion Amniotic Membrane, per sq. cm.
Q4277 WoundPlus™ Membrane or E-graft, per sq. cm.
Q4278 EPIEFFECT®, per sq. cm.
Q4280 Xcell Amnio Matrix®, per sq. cm.
Q4281 Barrera™ SL or Barrera™ DL, per sq. cm.
Q4282 CYGNUS Dual, per sq. cm.
Q4283 Biovance® Tri-layer or Biovance® 3L, per sq. cm.
Q4284 DermaBind SL™ per. sq. cm.
In hospital-owned outpatient wound/ulcer management provider-based departments (PBDs), all these new CTPs are packaged into the payment for their application codes and are assigned to the low-cost Ambulatory Payment Classification (APC) Group. Therefore, PBDs should report their application with C5271 through C5278.
CMS continues to remind wound/ulcer management stakeholders that the assignment of a HCPCS code and assignment to an APC Group does not guarantee that the CTP will be covered. Therefore, wound/ulcer management physicians and other QHPS should 1) research the published evidence pertinent to each CTP, including the type of wounds/ulcers studied in published trials, 2) thoroughly document the medical necessity for using the specific CTP, and 3) thoroughly document why that CTP was selected for the specific wound/ulcer—particularly if less expensive CTPs could have been used.
If the new CTPs are covered by the MAC that processes the physician’s/QHP’s claims, and if the physician or other QHP purchase the new CTPs for application in the office setting, they should next consider how the MAC will pay for the product. All the new HCPCS codes were assigned the Procedure Status Indicator of “E” on the Medicare Physician Fee Schedule (MPFS), which means that these codes are for items that CMS chose to exclude from the MPFS payment by regulation. No RVUs are shown, and no payment may be made under the MPFS for these codes. Payment for them, when covered, generally continues under reasonable charge procedures.
CMS Made Some Payment Status Changes for Three CTPs
The 3 affected CTPs are:
A2019 Kerecis® Omega3 MariGen® Shield, per square centimeter
A2020 AC5® Advanced Wound System (AC5)
A2021 NeoMatrix® Wound Matrix, per square centimeter
Effective for service on or after April 1, 2023, the 3 CTPs were assigned the Procedure Status Indicator of “C” on the MPFS, which means that contractors will price the code. Therefore, the A/B MACs (B) will establish the relative value units and payment amounts for these services, generally on an individual case basis following review of documentation such as an operative report.
Effective July 1, 2023, the 3 CTPs were assigned to the high-cost APC Group for the Outpatient Prospective Payment System (OPPS).
Wound/ulcer management professionals should exercise the same caution about coverage, as was described above. In addition, CMS has made it perfectly clear that they only cover CTPs that are packaged and applied in sheet form. This is true even if the CTP is assigned the OPPS packaged status indicator of “N” and even if the CTP is assigned to the high-cost APC Group.
UnitedHealthcare Revised Its Medical Policy
This author always pays attention to updates of several commercial payers’ medical policies that include reviews of published evidence about CTPs. One of the most thorough medical policies is UnitedHealthcare’s Skin and Soft Tissue Substitutes policy number 2023T0592R, that was updated on May 31, 2023.
When reading the updated medical policy, this author learned that UnitedHealthcare expanded the list of non-covered CTPs to include all the new products that were assigned HCPCS codes in 2023. In fact, this medical policy declares that 187 CTPs are unproven and not medically necessary due to lack of published evidence. Manufacturers and wound/ulcer management professionals should review the Clinical Evidence and Reference sections of the policy to better understand the type of published evidence that payers expect before covering CTPs.
NOTE: Like CMS, UnitedHealthcare does not cover CTPs that are in forms other than sheets.
Application of CTPs is the Subject of Audits
This author/consultant has been receiving many calls from physicians and other QHPs who are undergoing audits for the application of CTPs. In most cases, the lack of appropriate documentation prevented the physicians/QHPs from passing the audits. In addition, some of the repayments were so large that they even made the news for:
- Failing to describe a patient’s condition and detailed treatment at each encounter.
- Applying CTPs before standard of care was tried and failed.
- Reporting an evaluation and management service when a CTP was applied, and no other significant identifiable problem was managed.
- Reporting place of service incorrectly
Speaking of the correct place of service, in last month’s Business Briefs this author/consultant reminded physicians and other QHPs to verify if their MAC allows the application of CTPs (which is a surgical procedure) in the home, skilled nursing facility, and nursing facility now that the COVID-19 public health emergency has ended. Numerous physicians/QHPs have contacted me to say that their MAC is no longer covering that surgical procedure in one or more of those places of service. Therefore, the physicians/QHPs are now applying the CTPs in their offices or in hospital owned outpatient wound/ulcer management provider-based departments (PBD).
If you have not contacted your MAC, and your other major payers, about this place of service coverage question, you should make it a high priority. Be careful when you word the question. You want to know if 15271–15278 plus the appropriate CTP HCPCS code are “covered” in that place of service. Some professionals received totally different answers when the asked if the codes were “payable” in the home, skilled nursing facility, and nursing facility. This is a great example that “words matter” when asking coding, coverage, and payment questions to the MACs and other payers.
As a service to wound/ulcer management stakeholders, I will be glad to publish your collective informal survey findings in a future Business Briefs column. Please email me (kathleendschaum@gmail.com) with the following information that you learned when you queried the payer about performing the surgical procedure in the home, skilled nursing facility, and nursing facility:
- MAC or payer name
- Place of service in question
- Application code and CTP HCPCS code in question
- Professional type: MD, DO, DPM, NP, PA
- Exact coverage scenario that you posed to the MAC or to the payer.
- MAC or payer’s coverage answer
PS: I will not publish your name.
If wound/ulcer management stakeholders throughout the country respond with their informal survey findings, it will be interesting to see if the payers are consistent with coverage for the application of CTPs outside of the office and PBD.
Kathleen D. Schaum oversees her own consulting business and is a founding member of the Today’s Wound Clinic editorial advisory board. She can be reached for consultation and questions at kathleendschaum@gmail.com.
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