The subject of this article is surgical wound debridement performed by physicians. Surgical debridement is an important component of chronic wound treatment, and has been described by one author (along with systemic antibiotic therapy and strict measures to reduce weight bearing) as a “cornerstone of effective wound care.” Debridement is the process of removing de-vitalized tissue and foreign matter from a wound bed. Because devitalized tissue can impede the healing process, physicians often choose to debride a wound bed as part of the wound treatment process. Four methods of debridement exist:
3) enzymatic, and
This article focuses on surgical debridement.
Although there are a variety of CPT codes that describe debridement procedures, surgical wound debridement procedures are primarily coded in outpatient settings with CPT codes 11040-11044. The particular codes reported depend upon the types of tissues debrided, eg:
• 11040 (Debridement; skin, partial thickness);
• 11041 (Debridement; skin, full thickness);
• 11042 (Debridement; skin, and subcutaneous tissue);
• 11043 (Debridement; skin, subcutaneous tissue, and muscle); and
• 11044 (Debridement; skin, subcutaneous tissue, muscle, and bone).
These codes should not be confused with the active wound care management codes (97597-97602), which are usually reported by non-physicians for selective and nonselective debridement procedures, and are not to be reported with codes 11040-11044. Further explanation of the differences between these two code sets is available in Principles of CPT Coding 4th Edition by the American Medical Association.
Several points need to be highlighted regarding the surgical debridement code set 11040-11044:
The global period for 11040-42 is zero and 11043-44 is 10 days, meaning that all the pre-service, intra-service, and post-service work (up to 10 days for 11043-44) and cost to provide the service are included in the code:
• CPT guidelines do not restrict the number of times that the debridement codes can be reported for a course of treatment;
• Debridement codes may only
be billed once per lesion per debridement session;
• To report debridement of multiple sites (wounds), CPT codes 11040-11044 may be used more than one time in a single patient encounter. The appropriate code is selected for each site depending on the type of debridement performed, and the -59 modifier (distinct procedural service) is appended to
the secondary (and tertiary, if applicable) code.
These attributes of the 11040-11044 code set mean that the surgeon is not restricted as to when to report debridement. Below we discuss some of the legal issues that can arise with respect to debridement services.
II. Surgical Debridement and Medicare Requirements
In 2007, the Department of Health and Human Services Office of the Inspector General (OIG) issued a report titled Medicare Payments for Surgical Debridement Services in 2004. The OIG found that “Medicare allowed approximately 188 million in 2004 for surgical debridement services, [but that] [a]n estimated 64 percent of these services did not meet one or more Medicare program requirements.” The OIG recommended that CMS “strengthen program safeguards to prevent improper payments for surgical debridement services.”
In response to this report and reflecting ongoing efforts by CMS and its contractors to improve program integrity, local coverage determinations (LCDs) for surgical debridement have proliferated with specific coding guidance and requirements for medical record documentation as to whether debridement is medically necessary. Therefore, it is necessary that physicians fully understand all of the requirements imposed by their local Medicare Administrative Contractor (MAC) in LCDs and develop a system for consistently documenting what is necessary to satisfy each and every requirement. Physicians should expect that MACs will perform audits on claims for debridement as well as more extensive reviews of outlier physicians or clinics. If the result of such a review indicates that the medical record did not support medical necessity, then the MAC can institute corrective action, which can take one or more of several forms depending on the error rate. The actions a MAC can take include; provider education, request recoupment for the services reviewed, perform a more extensive claims review that can result in recoupment based on extrapolation, institute prepayment review and refer the provider to the fraud unit or the Department of Justice.
The three key issues that must be included in the medical record documentation are:
(1) demonstrating/supporting the medical necessity for performing debridement,
(2) showing that the extent of the debridement performed matches the CPT code that was reported, and
(3) showing progressive improvement with debridement over time.
Text descriptions of wounds in medical records and operative notes can be insufficiently clear or detailed to prove what procedure was performed and why it was performed. With medical necessity dependent upon the presence of de-vitalized tissue and coding dependent upon wound anatomy and the tissues that were debrided, before and after photographs or other images provide a more objective and reliable source of wound status. This can help defend medical decision-making (and the need for debridement) when a Medicare contractor or other third party payor questions the medical necessity or coding accuracy of debridement procedures. It is also important that the physician place documentation in the medical record contemporaneously with the timing of the debridement procedure so that the need for, and extent of, debridement are documented when this information is fresh in the physician’s mind and to avoid the issues associated with non-contemporaneous documentation.
III. Fraud and Abuse Laws and Debridement Practices
Like many areas of medical and surgical practice, even those where clinical guidelines are available, wound assessment and treatment planning depend upon the evaluation of the physician and the needs of the patient. Debridement procedures will generally be covered when they are medically necessary. In addition to following any applicable clinical guidelines, the physician should document her assessment of the wound and why debridement is medically necessary to enhance the healing process. Unless these things are contemporaneously documented in the medical record, medical necessity can be difficult to prove. Using memory to reconstruct the need for a service performed days or weeks earlier can result in inaccurate and inadequate documentation. It can also result in questions about the integrity of the medical record. Furthermore, the procedure performed must also match the service (CPT code) that was billed. Below we discuss some specific issues, some of which are particular to debridement and some of which are not.
A claim submitted by Medicare for a more extensive service than was actually performed is a false claim. This practice is known as up-coding. If a medical record review of documentation for debridement shows a consistent pattern or practice of up-coding, this pattern may raise the issue of intentional improper behavior, which can shift the focus of a review away from a contractor repayment request to an investigation of fraud and abuse by law enforcement officials.
Any defense to an allegation that the service performed did not match the code billed will need to include careful documentation of the medical necessity of the procedure, a complete description of the wound (including photographs or drawings) and a detailed description of each element of the procedure performed. For example, the procedure described by CPT code 11043 requires that muscle be debrided. During a post payment review, it would be helpful to have before and after photographs of the wound so that the muscle that was debrided can be easily seen.
Furthermore, the CPT descriptors for the debridement codes leave room for interpretation. Therefore, physicians must use common sense and make sure that the medical record documentation supports the code used. For example, the amount of muscle that must be debrided to justify the use of CPT code 11043 is open to interpretation. The payment for 11043 is almost five times more than the payment for 11042 (debridement of skin and subcutaneous tissue only) when performed in a hospital or ambulatory surgery center and is based on 45 minutes of intraservice physician work and has a 10 day global period (payment for 11042 is based on 15 minutes of intraservice physician work and has a 00 day global period). Therefore, it would appear prudent for physicians to consider coding 11042 if only a very de minimus amount of muscle was debrided (in addition to skin and subcutaneous tissue) unless the procedure was very complex and took much longer than 15 minutes. If 11043 is used in such a case, it is very important for the medical record to support the use of a muscle debridement code instead of the subcutaneous debridement code.
B) Medically Unnecessary Procedures
The local Medicare MAC debridement LCD (or private payor coverage policy) is the best source for information regarding medical necessity requirements for debridement. Claims reviewed by MACs that lack proper documentation of medical necessity can result in repayment requests. Similar to patterns of upcoding, patterns of utilization of debridement in which medical necessity is not supported by the medical record can result in more extensive medical record review leading to requests for recoupment based on extrapolation from the reviewed records to all claims. If the error rate is extremely high, there is a significant risk of referral to the appropriate authority to investigate the possibility of fraud and abuse (eg, submission of false claims). In the context of debridement, a physician is more likely to have her claims audited or reviewed if she is identified as an outlier. For example, if the pattern of practice in a certain jurisdiction is for debridement to be performed once or twice per wound, a physician who performed debridement weekly for several weeks on all wounds could be identified as an outlier and subjected to postpayment review. In this example, the physician would need to have documented the medical necessity for weekly debridement in order to avoid a request for recoupment or an investigation for abusive billing practices. Recently, some US attorneys have made false claims allegations based on extreme over utilization of services billed to Medicare.
Other practices which could result in scrutiny include performing more extensive debridement than is medically necessary (eg, debriding muscle to justify billing 11043 when it was not necessary to debride muscle), exaggerating the extent of de-vitalized tissue in the medical record to improperly support medical necessity, and performing an incomplete debridement for the purpose of having the patient return another day in order to bill another (unnecessary) debridement procedure.
C) Debridement Procedure Quotas and Other Forms of Fixed-Frequency Debridement
An arrangement where a physician is contractually obligated (by a written or verbal contract) to a wound center or other entity to perform a certain fixed number of debridements per month (or other period of time) or to perform debridements on a fixed percentage of wounds (or patients) treated per month (or other period of time), and at least some of these claims for such debridements will be submitted to Medicare and/or other Government payers, can be problematic. Such a contractual provision appears to require debridements to be performed for the purpose of generating revenue, not for the purpose of addressing the clinical needs of the patient. Therefore, if scrutinized, such an arrangement suggests that the debridements performed were not medically necessary and that the decision to perform a debridement was made on a basis other than clinical need. In general, decisions to perform services that are based on anything other than the clinical needs of the patient (eg, to generate revenue by satisfying a quota or other contractual requirement) may result in a request for recoupment and/or an investigation for fraud and abuse. If such a contractual requirement exists, it is especially important that the medical record demonstrate that every debridement performed was medically necessary for clinical reasons. Even with such documentation, it is possible that the government may take the position that the medical records cannot be relied upon due to the contractual requirement.
Furthermore, even if a contract that contains a “debridement quota” also includes a statement that “only medically necessary debridements are to be performed,” it is possible that the government would take the position that the medical necessity provision is subordinate to the requirement that the physician perform a certain number or percentage of debridement procedures, the purpose of which is to generate revenue and not to treat patients based on clinical need.
It is possible that an investigation into claims submitted for debridements that were performed by physicians who had contracts that included some sort of “debridement quota” could result in allegations, under Federal and/or State law, of criminal wrongdoing including the submission of false claims.
Physicians performing debridement must maintain a difficult balance. On the one hand, the clinical literature may recommend aggressive debridement for certain wounds, while on the other hand being too aggressive can result in claims review resulting in a request for recoupment or even allegations of fraud or abuse. Consistently documenting all of the information necessary to prove medical necessity and to support the code on the claim can seem like an onerous burden to a busy physician. However, it is a necessary part of a wound care practice, particularly given the attention that debridement has received from the OIG and Medicare contractors.
Agreements that call for physicians to perform debridement at a fixed frequency or according to a quota without regard to the medical necessity of a procedure for an individual patient may be problematic and could be viewed by law enforcement officials as evidence of intent to submit claims that the provider knew should not have been submitted.
Proper documentation and honest clinical judgments require effort but are worth it in the long run; such an approach is always the best way of showing an insurer or the government that appropriate patient care is always the highest priority. n
Dr. McInnes' practice also involves assisting pharmaceutical and device manufacturers with regulatory issues arising from Food and Drug Administration (FDA) oversight. This includes assisting clients with the FDA approval process, Hatch-Waxman issues, good manufacturing practices, and labeling and promotion. He has also assisted pharmaceutical and device manufacturers analyze their sales practices to ensure compliance with state and federal statutes regarding kickbacks and false claims as well as protecting private medical information.
Prior to joining Arnold & Porter, Dr. McInnes practiced as a corneal and refractive surgeon in Chicago, IL and West Chester, PA.
Dr. Paul Rudolf has significant experience in both Medicare and FDA legal, regulatory and policy issues, particularly those relating to counterfeit drugs and radiofrequency identification technology as applied to pharmaceuticals and medical devices. He also is widely recognized for his experience with coverage, coding, and reimbursement issues for hospital and physician payment systems under the Medicare payment systems.
Dr. Rudolf practiced medicine for more than 15 years and taught at George Washington University before becoming a Medicare Carrier Medical director. He subsequently joined the Centers for Medicare and Medicaid Services where he led policy development for the physician fee schedule and the hospital outpatient prospective payment system, and became recognized for his in-depth experience with coding and reimbursement for Medicare. Dr. Rudolf left the Centers for Medicare and Medicaid Services to join the FDA where he was a senior advisor for medical and health policy in the Office of the Commissioner. At the FDA, he led policy development for counterfeit drugs and radiofrequency identification technology and worked on issues related to follow-on biologics and pediatric medical devices. After leaving government, Dr. Rudolf worked for Avalere Health LLC, where he consulted for a variety of clients including pharmaceutical manufacturers, medical device manufacturers, healthcare technology manufacturers and physician trade organizations.
Dr. Rudolf has served in a number of elected and appointed positions in organized medicine including service on the Board of Trustees of the Medical Society of the District of Columbia and as chairman of the young physician’s section of the American Medical Association. Dr. Rudolf has received numerous awards for leadership and performance from the Administrator of CMS and the Commissioner of the FDA.