How Do We Get Coverage for Orthobiologics? The Problem With Assigning Success Rates to Specific Orthopedic Surgeries
How has Regenexx been able to get more than a thousand US employers to cover interventional orthobiologic (IO) procedures? One of the ways is to perform analyses of how IO procedures can help their employees avoid surgery, save them money, and reduce their time out of work. Today we’ll explore just one little piece of that calculus so that you can better understand how complex getting coverage can be.
Replacing the Need for Orthopedic Surgery Saves Big Bucks
We have been helping self-funded employers save money on their elective orthopedic surgery spend for many years now. This works because interventional orthobiologics procedures like PRP or Bone Marrow Concentrate can eliminate the need for many surgeries. For example, the average savings can be between 40-70% depending on the surgery replaced. This also means less invasive procedures with faster recovery times.
Controlling Utilization Is Key
While IO is a great leap forward in how patients with orthopedic and spine issues are treated, its downside is that it can become a cure-all for everything and be used in clinical scenarios where it doesn’t help avoid, postpone, or increase the results of surgery. For example, if the game plan was to perform a partial meniscectomy and that generates surgical fees as well as surgery center fees for the surgical practice, why not bill for adding a little PRP to that surgery? Or if an employer will cover the use of bone marrow concentrate in a patient with severe hip osteoarthritis, why not bill for that even when it likely won’t delay the need for a hip replacement?
To prevent this from happening and to ensure results for our corporate clients, we use advanced utilization management. That means we calculate how much can be saved by substituting IO for surgery and if that will save the employer money or cost them more. In IO cases with a high likelihood of improving patient outcomes and saving money, we approve those to go through. In cases where the IO procedure is unlikely to be effective and thus will cost more money, our system won’t authorize those procedures.
Knowing the Success Rate of the IO and Surgical Procedure Is One Part of That Cost Savings Calculus
We can easily use the world’s largest and oldest orthobiologics registry to calculate cost savings on the IO side. That’s because of this writing; we have outcome data for approximately 55,000 treated patients. However, how does that work on the surgery side? One of the things we need to know (among many other variables considered) is the success rate of the surgery we’re replacing.
To give you an idea of how complex this can be, we’ll look today at the success rate for one of the most common orthopedic surgeries in the US, which is a partial meniscectomy.
Determining the Surgical Success Rate for an Ineffective Procedure?
How do we determine the success rate of a procedure determined to be ineffective for any clinical indication but is still in daily and widespread clinical use? That’s something they don’t teach in medical school or even to clinical epidemiologists.
An arthroscopic partial meniscectomy (APM) of the knee is one of the most commonly performed orthopedic surgeries in the United States, with about 500,000 surgeries performed annually and a cost of around $3,800 (1). While the rate of these procedures has declined, it’s still one of the most widely used treatments for symptomatic meniscus tears.
The procedure fails along numerous healthcare economics dimensions, including its indication as well as the outcome of the procedure. Let’s explore both aspects of this issue.
The indication for the procedure is a meniscus tear. While acute meniscus tears due to trauma can occur in young patients, most APM surgeries are performed in middle-aged and older patients (2). The seminal problem is that these “injuries” aren’t acute episodes but, more commonly, normal degenerative changes (3). In addition, reviews of government imaging databases show that meniscus tears are common in patients with and without knee pain (4). Meaning in this patient population, we are literally operating on a clinical phantom.
That process of operating on something that doesn’t exist usually goes something like this:
A middle-aged or older patient gets sudden onset of knee pain, and eventually, an MRI is performed. That image shows a torn meniscus, which is presumed to be the cause of the knee pain. However, extensive research has shown that the meniscus tear is likely, not traumatic, and pre-existed the onset of knee pain. Hence, when the tear is operated on by removing part of the meniscus, this reduces the protection for the knee against arthritis as this structure acts as a critical spacer (14). Hence, the surgery does the exact opposite of what should be done.
In the other healthcare economics dimension, let’s review the outcome of the procedure. We have multiple Randomized Controlled Trials (RCTs) that show regardless of the clinical indication, APM didn’t beat either physical therapy or a sham procedure (5-10). Hence, the procedure should be eliminated, right?
Take this peer-reviewed published call for the elimination of the procedure (15):
“These data suggest a significant and troubling disparity between evidence and practice for one of the most common operations performed in the United States.”
Despite the data showing no efficacy and calls for the elimination of APM, the procedure remains common.
Figuring Out How Meniscectomy Should Be Treated in a Cost-Outcome Model
At Regenexx, we take the savings that IO procedures can generate seriously. Hence, we use a proprietary utilization management system.
One of the metrics that we plug into that system is the success rate of the surgery procedure versus that rate for the interventional orthobiologics procedure. For APM, given that most of these procedures are being performed in middle-aged and older patients, we’re really treating osteoarthritis. Hence, on the IO side, we have dozens of positive RCTs for platelet-rich plasma used to treat knee arthritis, including one for meniscus tears (11). We also have loads of registry data. However, what’s the success rate on the other side?
You could make a credible argument that the success rate for APM should be zero. However, given that orthopedic surgeons are still performing this procedure, it’s reasonable to take a harder look at what this number should be in a cost-saving model. For example, can we find any valid use for APM? Let’s dive in there.
A 2018 meta-analysis looked at the generalizability of the findings from some of the above-referenced RCTs (12). This study concluded that in some of the above RCTs showed that between 1/5th to 1/3 of patients failed conservative care and crossed over to the surgical group. That means the patient failed a trial of no surgery and then was operated on. Yet another systematic review concluded that the failed APM RCTs didn’t use the correct British and European guidelines (BASK) for that procedure, which are stricter than American standards (13). This review also brings up the conversion to surgery issue discussed above, as well as the fact that APM helps outcomes in the mid-term but that the differences are minor between it and physical therapy.
What Success Rate Should We Apply for APM?
Remember, this review isn’t about whether I, as a physician, would recommend APM for any patient. Given the data, it’s very unlikely that I would do that. Instead, it’s about whether the procedure is being done and what’s a realistic assessment in the best case of how often it produces a successful outcome.
Based on the published data, it’s reasonable, based on this review, to apply a success rate of between 20-33% for APM when used in its most common application of degenerative meniscus tears in middle-aged and early elderly people. On the one hand, given the failure of the procedure along multiple healthcare economic axes, you can make a valid argument for applying a 0% success rate. However, given that this procedure is still commonly being performed and some RCTs show a conversion of conservatively treated cases to surgery, you could also argue to apply the higher success rate. Hence, we decided to split the difference in the range and apply a success rate of 27% to the procedure.
The upshot? As you can see, ensuring corporate clients save money by adding IO isn’t a piece of cake. It takes quite a bit of knowledge about which IO procedures work and in whom they’re successful (i.e., our registry data), as well as what the peer-reviewed literature says about which surgeries work and how well they work. That often includes including not only what I would do as a physician but following where the medical literature leads.
References:
(1) Avila A, Vasavada K, Shankar DS, Petrera M, Jazrawi LM, Strauss EJ. Current Controversies in Arthroscopic Partial Meniscectomy. Curr Rev Musculoskelet Med. 2022 Oct;15(5):336-343. doi: 10.1007/s12178-022-09770-7. Epub 2022 Jun 21. PMID: 35727503; PMCID: PMC9463417.
(2) Reito A, Harris IA, Karjalainen T. Arthroscopic partial meniscectomy: did it ever work? Acta Orthop. 2021 Oct 4;93:1-10. doi: 10.1080/17453674.2021.1979793. Epub ahead of print. Erratum in: Acta Orthop. 2021 Oct 22;:1. PMID: 34605736; PMCID: PMC8815409.
(3) Risberg MA. Degenerative meniscus tears should be looked upon as wrinkles with age–and should be treated accordingly. Br J Sports Med. 2014 May;48(9):741. doi: 10.1136/bjsports-2014-093568. PMID: 24719404.
(4) Guermazi A, Niu J, Hayashi D, Roemer FW, Englund M, Neogi T, Aliabadi P, McLennan CE, Felson DT. Prevalence of abnormalities in knees detected by MRI in adults without knee osteoarthritis: population based observational study (Framingham Osteoarthritis Study). BMJ. 2012 Aug 29;345:e5339. doi: 10.1136/bmj.e5339. PMID: 22932918; PMCID: PMC3430365.
(5) Englund M, Guermazi A, Gale D, et al. Incidental meniscal findings on knee MRI in middle-aged and elderly persons. N Engl J Med. 2008;359(11):1108–1115.
(6) Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic Partial Meniscectomy versus Sham Surgery for a Degenerative Meniscal Tear. N Engl J Med 2013; 369:2515-2524
(7) Katz JN, Brophy RH, Surgery versus Physical Therapy for a Meniscal Tear and Osteoarthritis. N Engl J Med 2013; 368:1675-1684
(8) Sihvonen R, Englund M, Mechanical Symptoms and ArthroscopicP artial Meniscectomy in Patients With Degenerative Meniscus Tear: A Secondary Analysis of a Randomized Trial. Ann Intern Med. [Epub ahead of print 9 February 2016]164:449–455. doi: 10.7326/M15-0899
(9) Sihvonen R, Paavola M, Malmivaara A, Itälä A, Joukainen A, Nurmi H, Kalske J, Ikonen A, Järvelä T, Järvinen TAH, Kanto K, Karhunen J, Knifsund J, Kröger H, Kääriäinen T, Lehtinen J, Nyrhinen J, Paloneva J, Päiväniemi O, Raivio M, Sahlman J, Sarvilinna R, Tukiainen S, Välimäki VV, Äärimaa V, Toivonen P, Järvinen TLN; FIDELITY (Finnish Degenerative Meniscal Lesion Study) Investigators. Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear: a 2-year follow-up of the randomised controlled trial. Ann Rheum Dis. 2018 Feb;77(2):188-195. doi: 10.1136/annrheumdis-2017-211172. Epub 2017 May 18. PMID: 28522452; PMCID: PMC5867417.
(10) Noorduyn JCA, van de Graaf VA, Willigenburg NW, et al. Effect of Physical Therapy vs Arthroscopic Partial Meniscectomy in People With Degenerative Meniscal Tears: Five-Year Follow-up of the ESCAPE Randomized Clinical Trial. JAMA Netw Open. 2022;5(7):e2220394. doi:10.1001/jamanetworkopen.2022.20394
(11) Kaminski R, Maksymowicz-Wleklik M, Kulinski K, Kozar-Kaminska K, Dabrowska-Thing A, Pomianowski S. Short-Term Outcomes of Percutaneous Trephination with a Platelet Rich Plasma Intrameniscal Injection for the Repair of Degenerative Meniscal Lesions. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study. Int J Mol Sci. 2019 Feb 16;20(4):856. doi: 10.3390/ijms20040856. PMID: 30781461; PMCID: PMC6412887.
(12) Malmivaara, A. Validity and generalizability of findings of randomized controlled trials on arthroscopic partial meniscectomy of the knee. Scand J Med Sci Sports. 2018; 28: 1970–1981. https://doi.org/10.1111/sms.13215.
(13) Ahmed I, Dhaif F, Khatri C, Parsons N, Hutchinson C, Staniszewska S, Price A, Metcalfe A. The meniscal tear outcome (METRO) review: A systematic review summarising the clinical course and outcomes of patients with a meniscal tear. Knee. 2022 Oct;38:117-131. doi: 10.1016/j.knee.2022.07.002. Epub 2022 Aug 27. PMID: 36041240.
(14) Roemer FW, Kwoh CK, Hannon MJ, et al. Partial meniscectomy is associated with increased risk of incident radiographic osteoarthritis and worsening cartilage damage in the following year. Eur Radiol. 2017;27(1):404–413.
(15) Stahel PF, Wang P, Hutfless S, et al. Surgeon Practice Patterns of Arthroscopic Partial Meniscectomy for Degenerative Disease in the United StatesA Measure of Low-Value Care. JAMA Surg. 2018;153(5):494–496
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