CTPs: From Coding & Payment Changes (Then) To Coverage Changes (Now)

Information regarding coding, coverage, and payment is provided as a service to our readers. Every effort has been made to ensure the accuracy of the information. However, HMP Communications and the authors do not represent, guarantee, or warranty that the coding, coverage, and payment information is error-free and/or that payment shall be received. The ultimate responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.   Many qualified healthcare professionals (QHPs) who manage patients living with chronic wounds and many manufacturers of products such as cellular and/or tissue-based products for wounds (CTPs) [old term “skin substitutes”] often proclaim an unrealized hope that CTPs “have a code and a Medicare payment rate.” But remember, a product requires three things before it will be reimbursed by any payer, including Medicare: relevant codes, adequate payment rate, and coverage. For the past few months this column has discussed the 2014 code changes and Medicare payment changes for hospital-based outpatient wound care departments (HOPDs). Believe it or not, Medicare Administrative Contractors (MACs) have begun to make coverage changes for CTPs. Some of these changes have caught the industry by surprise. Let’s discuss some of the coverage changes occurring now.

  Prior to 2014, when new CTPs were launched into the marketplace, I maintained a color-coded map of the US representing each brand of CTP:
    - Red indicated states where the MAC did not cover the CTP;
    - Green indicated states where the MAC covered the CTP per a published local coverage determination (LCD); and
    - Yellow indicated states where the MAC did not publish an LCD and covered CTPs based on medical necessity.

  Upon any product launch, the US map is overwhelmingly red. If a product has published randomized clinical trials, the MAC(s) typically provide coverage, which turns those states on the map green. Because an LCD is not required for the MACs to provide coverage for any service, product, or procedure, not all MACs write an LCD pertaining to CTPs.

  In fact, prior to 2014:
    • One MAC (Palmetto GBA) chose not to write an LCD pertaining to CTPs.
    • Another MAC (Highmark, now Novitas Solutions Inc.) chose to write an LCD only about the CTPs the MAC wished to control. All other CTPs were covered based on medical necessity.
    • Several MACs (Cahaba GBA LLC; CGS Administrators LLC; Noridian Healthcare Solutions LLC) changed the titles of their LCDs to only pertain to the use of CTPs on lower extremities. All other wound types were covered based on medical necessity.
    • Other MACs (Cahaba GBA, CGS Administrators, and Novitas) identified covered indications for some wound types. In addition, those MACs stated their LCDs did not apply to treatment of wound types such as acute wounds, acute postoperative wounds, deep tissue reconstruction and/or replacements (eg, tendon and/or ligament augmentation/repair, breast reconstruction, abdominal hernia repair), burns, skin cancer, or pressure ulcers that were covered based on medical necessity. NOTE: Read your specific LCD for the exact details.

  The goal of every CTP manufacturer is to obtain positive or neutral Medicare coverage throughout the US. This means that my brand-specific coverage maps should ideally display mostly green states and a few yellow states, but no red states. However, during the first few months of 2014, the MACs have given the wound care industry a few coverage surprises, which have rendered my color-coded map project nearly impossible. Let’s look at a few of the coverage surprises:

  Noridian (JF) posted this notice Feb. 21:
   “Effective March 1, 2014, the LCDs L24273 and L24409 will be retired. Data analysis and recent Centers for Medicare and Medicaid Services (CMS) changes to reimbursement have been reviewed and Noridian feels these two LCDs, while still fundamentally sound, are no longer currently related to billing and coding. Noridian has determined that a portion of this LCD as it regards non-coverage of dressings remains pertinent and will be continued. This non-coverage will be transferred to the non-covered services LCDs L24473 (Part B) and L27445 (Part A). As this transference does not restrict coverage, no formal comment period is required. The only change in coverage reflects Noridian’s decision to provide coverage for Q4131 EpiFix,® per sq cm, beginning March 1, 2014. Noridian will allow coverage of the bioengineered products only in accordance with the respective FDA approved indications. We will continue to monitor utilization trends and, when deemed appropriate, require providers to submit their clinical notes to substantiate claims. Current wound care of diabetic foot ulcers and venous stasis ulcers continues to evolve. The main premise of any such care is the optimal provision of excellent wound care and the assurance of proper arterial circulation to the affected area. These items shall be clearly documented in the clinical records. We fully expect wound care medical professionals to adhere to the best evidence-based clinical standards as they continue to provide care to the Medicare beneficiaries.”

  For the first time, Noridian (JF) referred providers to its non-covered services LCD to see the list of non-covered products. (See Table at the end of article.) Therefore, I was able to color my brand-specific US map red for these non-covered products. Then I did something new: I changed the covered products from green to yellow because they went from positive coverage in the LCD to coverage based on medical necessity.

  On Feb. 22, Novitas released a future effective LCD 27547 “Wound Care and Cellular and/or Tissue-Based Products for Wounds” that was scheduled to become active March 27.
  This was the first time that a MAC attempted to combine coverage for the CTPs in an LCD with other wound care services and procedures. In addition, Novitas did not include a list of covered ICD-9-CM codes for any of the covered wound care products, services, or procedures. Shortly before this combined wound care LCD was scheduled for release, Novitas placed LCD 27547 “on hold” and reverted to the LCDs (L32622 and L27549) that were in effect Jan. 1, 2014. The Table reflects these LCDs. To provide readers with a preview of Novitas’ intentions, following are the CTP-related excerpts from the LCD that was placed “on hold”:

  CTPs for Wounds:
   “The provisions (products and procedures) of this LCD apply to payment for CTPs and the physician services reported for wound preparation and material application to chronic wounds. This LCD does not address human skin autografts, cadaveric human skin allografts, or porcine dermal xenografts, as specified by the Food and Drug Administration (FDA).

  Additionally, the provisions of this LCD do not apply to treatment of acute and acute postoperative wounds, deep tissue reconstruction and/or replacement (eg, tendon and/or ligament augmentation/repair, breast reconstruction, abdominal hernia repair), or burns. The following general indications and limitations to Medicare coverage and payment apply to all CTPs and physician services related to CTP application: Indications: Any CTP may be considered reasonable and necessary if it is provided in accordance with the materials labeled ‘indication provided in accordance with the manufacturer’s package insert instruction/guidelines under the 361 HCT/P provisions (21 CFR 1271) or FDA-approved/cleared package label with respect to application requirements, frequency, etc., either of which is uncontested by the FDA.’”

  Surgical Wound Preparation (Current Procedural Terminology [CPT] codes 15002, 15003, 15004, and 15005):
   “CPT codes 15002, 15003, 15004, and 15005 are used to report excision of nonviable tissue in preparation of a clean and viable wound surface for initial skin graft, flap, negative pressure wound therapy, or substitute graft application.

  Medicare does not expect to be billed for CPT codes 15002, 15003, 15004, and 15005 in conjunction with routine, simple, and/or repeat application of skin substitutes/replacements. Wound cleansing and removal of exudates, existing skin replacement graft material, and/or nominal amounts of devitalized tissue are included with the skin replacement application procedure. Medicare expects separate reporting of surgical debridement with application of skin replacements only when gross contamination requiring extended cleansing and removal of appreciable amounts of devitalized tissue are performed and documented. Medicare expects that most repeat applications of skin replacement materials will not require separate debridement procedures.” CTP Application Procedures (CPT codes 15271, 15272, 15273, 15274, 15275, 15276, 15277, and 15278):
   “American Medical Association CPT 2012 and CPT Changes: An Insider’s View 2012 contain vastly different descriptions of these CPT codes and their related preamble information. Providers are strongly encouraged to review and understand this information prior to the use of these codes. These application codes are not to be reported for application of non-graft wound dressings (eg, gel, ointment, foam, liquid) or injected skin substitutes.

  The CPT procedure codes listed in this policy describe and are to be used to report topical application of skin replacement or graft using CTPs. Do not report any CPT procedure code listed in this policy when using a CTP as an implanted or prosthetic material, or otherwise used not as an application to skin and surrounding tissues (eg, material used for non-skin applications such as tendon augmentation, breast reconstruction, ventral and incisional hernia repair, etc.).

  See CPT for coding instructions regarding non-topical use of skin and tissue replacement materials.”

   “As published in CMS Institute of Medicine 100-08, Section 13.5.1: In order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a) (1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
    • Safe and effective.
    • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after Sept. 19, 2000, that meet the requirements of the clinical trial’s national coverage determinations are considered reasonable and necessary).
    • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
      a) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
      b) Furnished in a setting appropriate to the patient’s medical needs and condition.
      c) Ordered and furnished by qualified personnel.
      d) One that meets, but does not exceed, the patient’s medical needs.
      e) At least as beneficial as an existing and available medically appropriate alternative.

  Post-payment medical review will be conducted as the primary method for ensuring that the above criteria are satisfied, by also using the FDA labels as more specific technical guidance.”

  For the first time, Novitas’ future effective LCD listed all CTPs that were assigned a “Q” code as covered based on medical necessity. Therefore, I color-coded my CTP maps yellow for each product in each state in the two Novitas jurisdictions. When the LCD was placed “on hold,” changes to color-coded maps were needed to reflect the Jan.1 status.

  Although I was surprised by the Noridian LCD and the future effective (now “on hold”) Novitas’ LCDs, First Coast Service Options Inc. surprised me the most when it retired its Part A LCD but maintained its Part B LCD. CAUTION: Do not confuse Part A and Part B Medicare payment with Part A and Part B LCDs. Part A LCDs pertain to all providers (eg, acute care hospitals, HOPDs, and hospital-owned ambulatory surgical centers [ASCs]) that use the hospital claim form CMS-1450s. Part B LCDs pertain to all QHPs who use the 1500 claim form. The retirement of the Part A LCD means HOPDs and ASCs will be covered based on medical necessity for any of the products with “Q” codes. The Part B LCD only provides coverage to five products (see Table), but does not mention the procedure codes for the application of CTPs. Therefore, QHPs have clear guidance for which products are covered in their offices, but do not have clear guidance about which products they can apply in facilities such as HOPDs and ASCs. The lack of direction in the Part B LCD causes QHPs to believe they may be covered based on medical necessity for CTPs applied in facilities. CAUTION: If QHPs want clarity about coverage for their work of applying CTPs in facilities, they should contact the medical director of First Coast.

  Following is the notice that First Coast released about the Part A and Part B LCDs: “Effective Jan. 1, 2014, CMS implemented an Outpatient Prospective Payment System (OPPS) change request edit (CR 8572) that requires hospitals to report all high-cost skin substitute products in combination with one of the skin application procedures described by CPT codes 15271-15278 and to report all low-cost skin substitute products in combination with one of the skin application procedures described by Healthcare Common Procedure Coding System codes C5271-C5278. All pass-through skin substitute products are to be reported in combination with one of the skin application procedures described by CPT codes 15271-15278. Based on this change in payment methodology in OPPS, the varied application of these products in the hospital setting, and the additional controls in the hospital setting, the MAC J9 retired the Part A skin substitutes LCD. Currently, the MAC J9 is silent on coverage for skin substitute services in the hospital setting, given there is no LCD or NCD in play. If a claim is audited, any service/procedure utilizing these products in an episode of care would have to meet the Medicare reasonable and necessary (R&N) threshold of coverage as documented in the patient’s medical record, assuming all other requirements of the Medicare program are met. The Part B LCD remains in effect and has limited coverage to the following four products: Apligraf,® Dermagraft,® Integra Dermal Regeneration Template,® and OASIS® Wound Matrix and OASIS Ultra Tri-Layer Matrix, with the R&N criteria as outlined in the indications and limitations section of the LCD. To review the products that remain non-covered, as medical necessity for these products has not been established, please refer to the Part B LCD skin substitutes L29279 (Florida) and L29393 (Puerto Rico/US Virgin Islands).”

  By now you can probably imagine that I have given up on updating my color-coded maps for each brand of CTP. First Coast’s separation of Part A and Part B coverage made this project much too difficult to maintain. Therefore, I’ve created the Table below to track CTP Medicare coverage. An “X” in the Table indicates the LCD specifically covers the product. An “MN” means the product may be covered based on medical necessity. A blank box signifies the product is not covered per that MAC’s LCD.

  REMEMBER: The Table is correct as of press time for Today’s Wound Clinic. Because the MACs can revise their LCDs at any time, be sure to assign someone in your practice to research your MAC’s LCDs and share changes on a monthly basis. Hopefully the Table will help you get started with this very important CTP coverage vigilance. Kathleen D. Schaum is president and founder of Kathleen D. Schaum & Associates Inc., Lake Worth, FL. She may be reached for questions and consultations at 561-964-2470 or kathleendschaum@bellsouth.net.