When it comes to cellular and tissue-based products (CTPs), it’s tough to keep up to date with new regulations because the market is flooded with products and there are a variety of approved modalities. If your wound care program uses CTPs as an advanced modality, there are certain rules you need to follow.ONE: You need to ask these questions - think N-I-D-AN: Is it medically Necessary? I: Is it free of Infection?D: Has it been Debrided?A: Have other Advanced modalities been tried, to no avail?If you can answer yes to all of these questions, you’ll most likely have a green light in terms of coverage by CMS and/or your patient’s insurance, because CTPs would be a logical next step.It’s very important that the wound is ready for CTP treatment, however. If you use a CTP but don’t address the true underlying condition of the wound, it won’t work and you may be denied for it later.TWO: Pay close attention to LCDs and the number of allotted applicationsKnow the guidelines and standardize them, across the board. Some LCDs allot a certain number of applications, such as 10 or 12. Some are based on package inserts, which offer a recommended number of applications. For example, if a CTP recommends 10, then CMS rules indicate that you need to stay within those recommendations. If you go over, you’d better document why, and be specific.THREE: Be mindful of costsFor CTPs, the cost falls within two buckets - high and low. Each bucket will reimburse differently based upon which bucket it falls into. High-cost CTPs will obviously cost more initially. However, as the treatment continues and the wound improves, you should be using smaller sizes at a lower cost to your clinic per treatment. (Remember skin subs come in multiple sizes - and they should be sized to fit.) If your revenue isn’t increasing as the wound gets smaller, you should take a look as to why.FOUR: Use available resources for assistance, when neededFor WCA partners, we have a CTP hotline available through our Luvo platform. We have a specialized team to review documentation for medical necessity, and we double check ICD-10 codes. Remember that just because the FDA has approved the use of a CTP, it does not mean CMS will pay for the use of that CTP. It’s very important to go to the source of the reimbursement to ensure “medical necessity” is provided.FIVE: Plan on being auditedIf you operate your wound care program with the general idea that you will be audited, you will consistently review documentation and make sure every treatment is medically necessary. If you don’t have someone auditing your charts already, you should. When it comes to billing, there are two common misconceptions that can get you into trouble: 1) “We’ve already been paid for the applications, so why are we worried?” or 2) “We’ve been getting paid, so we must be doing it right.”It’s important to remember that although you’ve been paid initially, you should never assume that CMS can’t - and won’t - come back and request back payment. They can still deny your claim. If there isn’t sufficient information in the chart to support medical necessity, there won't be sufficient information to argue the denial. Appropriate and accurate documentation and the review of that documentation prior to submitting for reimbursement will save you a lot of problems in the long run.A Word About CTP Vendors:With over 200 CTPs on the market and multiple manufacturers actively promoting them, obtaining accurate information on usage can be difficult. The key point to remember is that Medicare justifies the use of CTPs only after the wound has failed to respond to standard treatment of more than four weeks-- and after specific interventions have failed despite patient compliance. At this point, CMS requires a list of qualifications that must be detailed in the chart including what was done in the past, what is being done currently, and what is planned for future treatment. If one aspect of these qualifications is missing from the chart, it gives CMS an avenue of approach to deny and recoup the money that was paid. CMS is not dictating treatment, rather, it is requiring justification for it.Occasionally, manufacturing companies will state that a CTP can be used anywhere on the body, on any wound type. If you want CMS or a private payer to cover the costs, there must be medical necessity. Both groups are becoming increasingly specific about what they will and won’t cover. For example, if a CTP is indicated for a full-thickness wound, it’s not the same as an indication for bone, tendon, or muscle. It’s important to be aware of the differentiation between what the FDA approves, and what CMS and private payers approve. The FDA may ensure that a product is safe, but it is not the organization that reimburses. If a denial occurs, it’s the hospital and/or patient who may be obligated to pay a $20,000 price tag.In conclusion, CTPs can play a vital part in healing our patients, however, not every patient or wound is a candidate, especially if standard wound care is not followed first. It’s critical to follow the rules, regulations, and guidelines set by CMS.If you have questions, or if you’d like help with managing your wound care program, please give us a call at 888-484-3922.