This is the third installment of a post by Michael Crouch recounting in exhaustive detail one clinician’s journey through a 15-month audit on her use of “skin substitutes” (CTPs/CAMPs). Mr. Crouch’s 3-part article can serve as a blueprint for the hundreds of other practitioners currently working through their own skin substitute audits. In Part One he provided details of each step in the process. Be sure to review the list of reasons for denial by the Unified Program Integrity Contractor (UPIC), Medicare Administrative Contractor (MAC) and Qualified Independent Contractor (QIC) in Part One, because they are surprising!
After months of appeals and repeated defeats, by step #10, I would have given up the fight. However, Mike and his client requested a hearing from an Administrative Law Judge (ALJ). Evidence was presented to the ALJ as part of a third level of appeal. The 42 page ALJ decision was favorable, and the clinician was able to keep most of the revenue under audit. The ALJ’s lengthy and detailed decision provided a significant rebuke to all three contractors’ decision process. Many of you have contacted me to say that you are engaged in a similar fight and found these materials useful. I am glad!
Despite all the details provided, I didn’t think that the story was finished. It seemed to me that this journey provided many important lessons for clinicians using CTP/CAMPs, so in the Third and Final Part, I asked Mike to summarize the lessons learned from this long and difficult process.
–Caroline
Dr. Fife,
I am happy to provide what I think are the “lessons learned” from this arduous audit over the use of CTPs/skin substitutes.
Reasons Why this Clinician Survived the Audit:
- Documentation:
- The clinician had excellent documentation for the majority of the patient accounts and took great care to review and update follow-up notes.
- In addition, she was diligent in following the LCD requirements and ensuring that there was documentation of the 30 days (or more) of conservative wound care measures prior to the utilization of this expensive treatment modality, as well as wound progress from the products.
- Despite the auditors’ determination to deny payment for allograft products, the only charges the clinician wasn’t able to protect were those for which her documentation was imperfect. Even minor omissions can result in a claw back. The documentation requirements are extensive, not just for the duration of CTP treatment but for the four weeks prior to the CTP application.
- Utilization:
- The clinician did not overuse/abuse the skin substitutes. She had an average of only five applications per patient for the twelve accounts (and none exceeded 10 applications) — an important aspect of obtaining a favorable decision.
- Product selection:
- Since there are many products to choose from, the clinician used sound judgement when establishing her product inventory and did not utilize only the highest-priced products.
- As a side note, amniotic products seem to be a target for the audits I have been involved in, but that may all become a moot point now that CMS has implemented price controls. Nevertheless, practitioners can expect to be audited on their past use of CTPs.
- Evidence:
- Be prepared to send copies of journal articles and scientific publications to demonstrate the clinical effectiveness of the product(s) you are using.
- This evidence was highly considered by the ALJ in making his decision.
- This is a warning to manufacturers to obtain published evidence on the effectiveness of their products because clinicians may need those publications to keep their payments.
- Harsh realities:
- A UPIC audit is labor-intensive, time-consuming, and has a hard deadline, which should be taken seriously.
- The information requested in an ADR is non-negotiable and, if missing, will often lead to denial for that date of service.
- Auditors are instructed to disregard any information that does not meet the Medicare signature requirements.
- The percentage of failing a UPIC audit is high (remember, their motivation comes from claiming a percentage of recouped monies), so prepare for a demand of repayment (“clawback”) of the contested monies from your regional MAC.
- The appeal process is complex and can take an extraordinary amount of time – – more than a year, depending upon the number of levels included.
- Do not let these difficulties discourage you from appealing a denied decision! If you are providing high quality care, your documentation is sound and your use of products responsible, you can prevail.
- Do seek expert advice from consultants or attorneys who are familiar with the process.
Lessons Learned:
- Documentation requirements for the application of skin substitute grafts are detailed, specific and must be followed carefully.
- When UPIC auditors review charts for the application of CTPs/CAMPs, their primary focus is determining whether documentation supports the medical necessity (reason/rationale) of the advanced therapy.
- This includes documentation of the intent to utilize the advanced therapy prior to the first application.
- Documentation must clearly indicate a description of the ulcer(s)/wound(s) at baseline (prior to beginning conservative wound care measures) relative to size, location, stage, duration, and presence of infection, in addition to the type of treatment given and response.
- Conservative wound care treatments include, but are not limited to, debridement, pressure relief, compression therapy, infection control, exudate management, maintenance of a moist environment and smoking restrictions for at least 6 weeks prior to skin substitute application (or has received counseling on the effects of smoking on surgical outcomes).
- This information must be updated in the medical record throughout the episode of skin replacement wound care.
- In addition, ulcers/wounds must be free of infection and underlying osteomyelitis, and documentation must include the conditions which have been treated and resolved prior to the utilization of a skin substitute.
- Other elements examined by the auditors include the application procedure details, such as wound location, wound bed preparation, wound size and application area, product name and size, amount applied, amount wasted, how product is held in place (bolstered), and finally how the patient tolerated the procedure.
- Documentation is also scrutinized to determine if there is supporting evidence for utilizing more than one specific skin substitute product per wound episode (defined as 12 weeks after the 1st application).
- Repeat applications within the 12-week wound episode may be considered upon wound re-assessment but must be supported in the medical record.
- Repeat applications beyond the 12-week wound episode could result in claim denial(s) and/or initiate a request for records and complex medical review.
- Repeat applications of skin substitute grafts are not considered medically reasonable and necessary when a previous application has a “Failed Response”.
- “Failed response” is defined as an ulcer that has increased in size or depth, or no change in baseline size o+r depth, or no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing).
- Finally, there must be documentation of offloading measures taken, when applicable, and that a clean moist bed of granulation tissue, with appropriate moist dressing, was present during the course of therapy. If there is no documentation addressing any of these aspects, the entire date of service will be denied.
After reading the above list, it is no wonder that many practitioners have experienced a clawback of some or all of their Medicare payments for skin substitutes. Every minute you spend providing and documenting high quality care is an hour you will not have to spend defending your payments.
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
