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‘Not medically necessary’: Follow practical considerations for patellofemoral cartilage restoration
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Editor’s note: Members of the Patellofemoral Foundation review and add clinical perspective to recently published studies on the causes, prevention and treatment of patellofemoral disorders. The twice monthly blogs are edited by John Fulkerson, MD, and can be found on www.healio.com/orthopaedics. To read all the Patellofemoral Update blogs, click here.
Previous Patellofemoral Update blogs have detailed the options and rationale for cartilage restoration in the patellofemoral compartment. In patients who have failed appropriate nonoperative treatment for patellofemoral chondral lesions, these surgical options appear encouraging. The available literature on patellofemoral cartilage restoration demonstrates mostly good to excellent outcomes, further stimulating the initial enthusiasm for these procedures. The procedures have the opportunity to help patients improve their quality of life.
The physician-patient relationship works when informed decisions are made as a team, by balancing the patient’s goals and expectations with the best available peer-reviewed evidence about treatment options. However, it is becoming increasingly clear in the world of patellofemoral (PF) cartilage surgery that this coveted relationship is being “modified” by a third party – the payer. And the payer often has only a few choice words for the surgeon and patient – “not medically necessary.”
Reality of the situation
To better understand and deal with this presumed “catch 22,” it is important we recognize the reality of the situation: the tail (payer) often wags the dog (surgeon). That is what procedure the payer will allow dictates treatment, as most patients cannot self-pay. In the payer world, decisions on medical necessity are, at best, difficult to understand and, at worst, frustrating. To the surgeon, the wording and logic seems circular. For example, all treatments that do not meet the payer medical policy are by their definition “not medically necessary.” Patella lesions often are not even within the medical policy for cartilage restoration, and therefore are deemed not medically necessary.
As PF cartilage surgeons, our obligation is to provide the best available evidence-based treatment options for patients, while taking into consideration the cost-effectiveness of the interventions. Our patients often fail conservative management (NSAIDs, bracing, activity modification and injections) and arthroscopic interventions (i.e., debridement) before consideration of salvage cartilage restoration surgery. In cases of distal and/or lateral patella chondrosis, isolated anteromedialization tibial tubercle osteotomy (Fulkerson osteotomy) may obviate the need for complex cartilage restoration. Cartilage restoration is often indicated as an adjunct to Fulkerson osteotomy for the treatment of more extensive PF chondral pathology, e.g., medial, proximal, pan-patella or bipolar.
We all understand the literature’s “state-of-the-art.” We know patella marrow stimulation outcomes are often suboptimal. We recognize that osteochondral autograft plugs for the patella are performed rarely, with mixed results ranging from poor to excellent. Thus, the majority of PF cartilage restoration involves one of the following: autologous chondrocyte implantation (ACI), particulated juvenile allograft cartilage (PJAC) or osteochondral allograft (OCA). While most lesions could be treated with any of three options, many surgeons prefer cell-based therapy (ACI and PJAC) for cartilage only lesions and OCA for uncontained lesions, especially for patients with eburnated bone or some degree of bone loss.
Barriers to payer coverage
For a variety of reasons, each treatment has barriers for payer coverage. Often, none of these “go-to” procedures are approved outright and thus require multiple appeals. Sometimes, the least desirable option is approved while the favored patient specific option is denied.
At the heart of the matter is the medical policy. An example of an insurance medical policy may be viewed at http://www.anthem.com/medicalpolicies/policies/mp_pw_a053500.htm. The medical policies are set up, payer by payer, based upon their interpretation of our evidence-based medicine. Often these interpretations vary from one payer to the next.
As orthopaedic surgeons, we understand the debate on how to interpret the literature. The American Academy of Orthopaedic Surgeons (AAOS) has published many clinical practice guidelines (CPGs), which require high levels of evidence to demonstrate the efficacy of a procedure. We have come to realize that many treatment decisions we make on a daily basis may not ever have sufficient level 1 and level 2 evidence to support their effectiveness compared with others. For example, if the CPG for the treatment of osteochondritis dissecans (OCD) was strictly followed, then we would have absolutely nothing to offer our patients. Yet, surgeons must and do make patient decisions regarding the treatment of OCD lesions on a regular basis to improve quality of life. Payer’s medical policies take this a step further. While the AAOS may label evidence for a treatment as “weak” or “inconclusive,” the payer will state the treatment is not medically necessary and thus not available for payment.
Level of evidence
Common denial language often states the requirement for this higher level of evidence – the need for prospective, randomized, controlled trials published in the peer-reviewed literature. The payer develops policies for most medical conditions using criteria set in their medical policies. These policies are often developed using standards developed in internal medicine with pharmaceutical involvement. This means large cohorts of patients — think hypertension and diabetes — even though pharmaceutical research standards cannot be directly applied to surgical procedures. When was the last sham vs. total knee arthroplasty study performed? For treatment of rare orphan diseases, there are unique treatment protocols allowed by payers and the FDA alike. Despite the niche area of PF cartilage surgery, there are no such exemptions for PF cartilage surgery. Who are the real “orphans” in this situation?
Fortunately, the AAOS is developing appropriate use criteria (AUC) to help provide practical guidance for surgeons to make educated decisions for their patients despite the limitations of the available literature — often level of evidence 4 studies are available. These AUC combine the best scientific evidence from the CPGs, tempered with the clinical experience and judgment of experts in a given field to determine the appropriateness of performing a procedure. Unfortunately, this same practical approach has not been applied to payers’ medical policies. The hope is this will change over time.
Tips to obtain coverage
How does anyone ever obtain approval from the payer to perform PF cartilage restoration? The following steps can assist you in helping patients obtain the medically necessary treatment they need:
- 1. Go to the website of the major payers and print their medical policies on specific cartilage procedures. Search by name or CPT code (e.g., 27412 and 27415). Have the policies available for review preoperatively during patient counseling.
- Educate and set realistic expectations for the patient. You will find that some payers will never allow PF cartilage restoration. Patients need to know to avoid the heartache of a failed prolonged appeal process. For other payers, it is highly variable. Two patients with the exact same lesion – one receives approval after appeal and the other patient does not. Regardless, the need to appeal and re-appeal is more common than approval.
- At this point in time, payers demand intra-operative lesion measurements and documentation of failure of one prior treatment. This dictates that the “definitive” cartilage restoration is not done as a single surgery – even if technically possible (e.g., PJAC and OCA).
- Some payers may say preauthorization is not necessary. That does not mean you can do what you want. It means preauthorization is not necessary if the procedure meets all the medical policy criteria. If not, then the payer will deny the claim months later and will want payments returned. You will then hear from an unhappy patient. If the payer continues to decline the preauthorization, then request predetermination that the proposed surgery complies with their medical policy.
- Most payers want preauthorization. Dictate a preauthorization letter after you dictate the operative note using each bullet point of the payers’ medical policy. Failure to use their template will result in denial for what seems obvious (e.g., you failed to state the knee is not infected or involved with cancer).
- Clearly state the lesion is in the patella and this falls outside of the medical policy. Ask the patient to request a decision timeline. A quick denial is best as this allows an appeal process to start. You cannot appeal without a denial.
- Educate the patient and yourself on the appeal process. This is a payer-specific process that must be followed to the letter. The first written appeal should focus on the literature. Document that the world literature in this area does not have prospective, randomized, controlled trials and the best evidence for or against is level of evidence 4. There are many publication on PF applications for ACI, fewer publications for OCA and presently only one for patellar PJAC.
- Eventually, there is often a peer-to-peer review. During that phone call, you will talk to a nice physician who typically does not perform orthopaedic surgery, let alone PF cartilage surgery. The physician typically can only reiterate the payer medical policy. Be polite and you go to the next level of appeal.
- Request either an external review or a true peer-to-peer with a practicing orthopaedic surgeon with experience in PF and cartilage surgery or with the medical director. Emphasize the difference in medical policies and CPGs with respect to the real world we live in, where a patient has a treatable lesion that can be well managed if more of an AUC approach is used. You are the expert in real world clinical practice who must make the best decision for your patient based on the best available literature — often level of evidence 4. The patient’s problem will not go away as they need treatment. Patellofemoral arthroplasty is not indicated for these patients and patellectomy is no longer a rational alternative.
- When all appeals are exhausted, restate the literature and restate all the options and then request the payer list what options they will allow for the treatment of this patient in pain.
Keeping a calm approach is key. The payer’s employees are typically nice and caring people who are just following the guidelines given to them. You are the patient’s only hope in their managing to find the way through the maze to the ultimate goal of proper medically necessary treatment.
- References:
- Farr J. Recognize the unique characteristics of the patellofemoral joint. Available online at: http://www.healio.com/orthopedics/blogs/patellofemoral-update/recognize-the-unique-characteristics-of-the-patellofemoral-compartment.
- Pidoriano AJ. Am J Sports Med. 1997;25(4):533-537.
- Schepsis AA. Avoid overtreatment of patellofemoral chondrosis/arthrosis in the athlete. Available online at: http://www.healio.com/orthopedics/blogs/patellofemoral-update/avoid-overtreatment-of-patellofemoral-chondrosis-arthrosis-in-the-athlete.
- The Diagnosis and Treatment of Osteochondritis Dissecans. AAOS Guidelines and Evidence Report. Dec. 4, 2010.
- For more information:
- Jack Farr, MD, is medical director, OrthoIndy Cartilage Restoration Center of Indiana, and director, OrthoIndy Sports Medicine Fellowship, Indiana Orthopedic Hospital, Indianapolis, Ind., USA. He is also professor of Orthopedic Surgery, Volunteer, Indiana University Medical School.
- Seth L. Sherman, MD, is an assistant professor, Department of Orthopaedic Surgery, School of Medicine, University of Missouri Health Systems.
Disclosures: Farr receives research or institutional support from Sanofi Company formerly Genzyme Biosurgery, Histogenics, Johnson & Johnson companies, DePuy/Mitek, RTI Biologics and Zimmer; receives miscellaneous non-income support, commercially derived honoraria or other non-research-related funding from Arthrex, Sanofi Company formerly Genzyme Biosurgery, Johnson & Johnson companies, RTI Biologics and Zimmer; receives royalties from Arthrex, Johnson & Johnson Companies, DePuy/Mitek, DePuy Orthopaedics; and is a consultant for Arthrex, Sanofi Company formerly Genzyme Biosurgery, Johnson & Johnson companies, ISTO Technologies, RTI Biologics Cartilage Advisory Panel, and Zimmer. Sherman is a consultant for RTI.
Perspective
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Prof. George Bentley, MB, ChM, DSc, FRCS, FRCS(Ed), FMedSci
This useful paper reflects the North American perspective where patients are mainly athletes whose treatment is paid for by insurance whereas in Europe the majority are treated in a state-financed system. Nevertheless the principles of diagnosis and management are very similar.
The essential responsibility of the surgeon is to decide with the patient what they need personally for their problems and to provide their best solution as rapidly and effectively as possible.
Patellofemoral instability must be recognized and analyzed carefully and treated.
Data on results with a host of other methods for larger lesions is scant but the following points should be considered:
- Traumatic lesions (including osteochondritis dissecans) usually fare better than others such as chondromalacia patellae, lesions on the lateral facet and those associated with instability or early osteoarthritis.
- If the cartilage lesion is less than 5 mm in diameter, there is no evidence for cartilage repair procedures, and microfracture is reasonable.
- For larger lesions, our experience outlined in studies published in 2012 and 2014 shows superior results with primary treatment by ACI (autologous chondrocyte implantation) or MACI (matrix-induced autologous chondrocyte implantation) to those previously treated by surgery.
- Excellent and good results (based on Cincinnati, VAS and Stanmore scores) are only achieved in 55% of patients overall. All patients should recognize the variability of results.
In general, the patients who fare best are the highly motivated athletes who participate actively in the rehabilitation program.
Surgeon experience and judgment are intangible but important in achieving good results.
References:
Macmull S. Int Orthop. 2012;doi:10.1007/s00264-011-1465-6.
Nawaz SZ. J Bone Joint Surg Am. 2014;doi:10.2106/JBJS.L.01695.
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