Not a week goes by without a wound care professional or a wound care manufacturer calling and asking 1 or more of the following questions about cellular and/or tissue-based products (CTPs) for skin wounds (old term "skin substitute"):
* Who is the Medicare Administrative Contractor (MAC) that writes the local coverage determinations (LCDs) for my state?
* How can I tell what CTPs are covered by Medicare in my state?
* Is [a specific brand] of CTP covered by Medicare in my state?
* I just moved from [one state] where [a specific brand] of CTP was covered, but I heard it is not covered in [the other state] where I just moved. Can it be true that all Medicare beneficiaries do not have access to the same technology?
* Why did we stop calling these products "skin substitutes"?
In the early days of Medicare coverage for CTPs, approximately 50 Medicare contractors processed claims and wrote LCDs pertaining to CTPs. In each state, 1 contractor processed the Medicare Part A claims, and another contractor processed Medicare Part B claims. The facilities and hospital-based outpatient wound care departments often had different LCDs from the qualified healthcare professionals (QHPs). Therefore, hospital-based outpatient wound care departments and QHPs, who wanted to apply CTPs, often had to comply with the different coverage requirements of 2 LCDs. Luckily, back then, fewer than 5 CTPs were on the market. Most of the Medicare contractors required a published, randomized controlled trial (RCT) before they would provide positive coverage for the CTPs. As each product reached that hurdle, the Medicare contractors typically provided positive coverage for the product.
Later, the Centers for Medicare & Medicaid Services (CMS) reduced the number of Medicare contractors by creating 10 jurisdictions. The CMS awarded contracts to MACs who processed both Medicare Part A and Medicare Part B claims and wrote LCDs that applied to both facilities and QHPs. However, confusion still existed because as the number of Medicare contractors decreased, the number and type of CTPs increased exponentially. Each MAC medical director was faced with writing an LCD that consistently controlled the utilization of the disparate categories of CTPs. Some MACs required published RCTs before they would provide coverage for CTPs. Some MACs provided coverage for products that did not have published RCTs. Some MACs provided very clear directions about the requirements for coverage. Some MACs did not provide any direction, but appeared to have unwritten requirements that the manufacturers and providers learned about when they requested positive coverage through the LCD Reconsideration Process.
Most recently, several MACs have taken new approaches to the coverage of CTPs. Some MACs, who had a strict LCD in the past, actually retired their LCDs, which means that all CTPs may be covered based on documented "medical necessity." Some MACs removed the list of covered diagnosis codes and placed the onus on QHPs to order products based on the indications listed on each product's instructions for use. Some MACs provide extensive lists of covered diagnoses; in fact, some MACs specify diagnosis codes that can be used alone and diagnosis codes that must be used in combination. Some MACs list the names and codes of the covered products, and other MACs say that all products may be covered based on documented "medical necessity." Most of the MACs who have published LCDs state that the LCDs pertain only to chronic wounds of the lower extremities: other wound types may be covered based on documented "medical necessity."
Now you can see why I titled this article the Wild, Wild West of Medicare Coverage for CTPs! Because a picture is worth 1000 words, I have created a few tables that should help wound care professionals and wound care manufacturers answer their numerous Medicare coverage questions that pertain to CTPs
Q: Who is the MAC that writes the LCDs for my state?
A:Table 1 lists the Medicare jurisdictions, the MACs, the MAC medical director(s), the link(s) to the MACs' LCD web pages, and the states in each MAC's Medicare jurisdiction. Wound care professionals should check with their billers to be sure that the MAC listed for their state actually is the MAC that processes their claims. In some instances, corporate facilities may send their claims to a different MAC. In that case, identify the name of that MAC and follow that MAC's LCD, rather than the LCD of the MAC listed for your state in Table 1.
Q: How can I tell what CTPs are covered by Medicare in my state? Is [a specific brand] of CTP covered by Medicare in my state? I just moved from [one state] where [a specific brand] of CTP was covered, but I heard it is not covered in [the other state] where I just moved. Can it be true that all Medicare beneficiaries do not have access to the same technology?
A: Yes, it is true that Medicare beneficiaries who live in different states do not have access to the same CTPs. Wound care professionals and wound care manufacturers can visit the MAC's LCD web page listed in Table 1 or can visit the Medicare Coverage Database, which houses LCDs for all the MACs: https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx. A comprehensive Table 2 is available as a Supplemental Digital Content, http://links.lww.com/NSW/A0, and provides a basic overview of the LCDs pertinent to CTPs that existed on May 5, 2016. This author cautions all readers to review the entire LCD (not just the information in Table 2) and to visit your MAC's LCDs on a monthly basis: look for revisions to the active LCDs, newly retired LCDs, draft LCDs (for which you should submit comments), and future effective LCDs. In 2015, some MACs revised their LCDs, pertaining to CTPs, more than 5 times.
Q: Why did the wound care industry stop calling these products "skin substitutes"?
A: The answer is quite simple. The FDA does not allow these products to be called "skin substitutes" because they do not actually substitute for skin. Many years ago, the CMS removed the term "skin substitute" from the HCPCS code descriptions for these products. Now each HCPCS code description is the brand name(s) of the product. For approximately 4 years, many wound care scientists and physicians worked collaboratively with ASTM International to develop a new term and a new standard that is inclusive of all the products in this space. In February 2016, the new ASTM standard (F3163-16) was officially released and is titled, Standard Guide for Classification of Cellular and/or Tissue-Based Products for Skin Wounds. A copy of the CTP standard can be purchased online from ASTM International for your personal use: http://www.astm.org/Standards/F3163.htm.
The entire wound care industry should cease using the term "skin substitute" and should use the term "CTPs" for skin wounds. In fact, 1 MAC, CGS Administrators, LLC, has already labeled their LCD with this correct term. Several other MACs refer to CTPs in their LCDs, but have not fully converted to the correct term. The rest of the MACs describe CTPs in a variety of ways.
As you communicate with your MAC medical directors, please encourage them to refine their LCDs with the new CTP term. Hopefully, the American Medical Association will make a simple editorial change to the CPT(R)* Manual to align with the new ASTM-approved terminology. The last step will be for the CMS to make an editorial change to its HCPCS code descriptions for C5271-C5278. In the meantime, wound care professionals and the wound care industry should use the correct terminology when referring to CTPs for skin wounds.
*CPT is a registered trademark of the American Medical Association.