The Insurance Coverage Bioethics Dilemma

Published on Apr 2, 2021

There a raging controversy among physicians since the advent of orthobiologics that I would like to explore. Should a doctor push a patient towards something that may work, but is a bad or “less good” option solely because there is insurance coverage? What ethical responsibility does the physician have to recommend all options and encourage the better option even if there is no insurance coverage? Let’s dig in.

The Genesis of this Debate

Orthobiologhics like PRP, bone marrow concentrate, or micro fragmented fat can be game-changers. Unlike the steroid or surgical procedures they replace, they are more likely to be regenerative than destructive. The problem? Outside of our Regenexx corporate program, they’re generally not covered by the patient’s insurance plan.

What is the doctor’s responsibility to push the patient towards the option that’s better for them, even if that option isn’t covered by insurance? Should insurance be factoring into any medical decision, or is that unethical on the doctor’s part? This debate goes deep, with many of my colleagues firmly on one side or the other. Meaning some doctors feel that insurance coverage should have nothing to do with what procedures they recommend and how they steer a patient toward treatment options. Others feel very strongly that while it may not be right, it’s only practical to allow insurance to push a patient towards a specific option that is covered, even if that option is not as good for them as one that isn’t covered.

So today we’ll review the ethics of two clinical scenarios: knee arthritis and SI joint instability.

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Knee Arthritis is a Modern Medical Ethical Dilemma

Right now, the most evidence-based treatment for knee arthritis is platelet-rich plasma (PRP). In fact, nothing comes a close second. For example, we have a recent meta-analysis (the king of studies or Level 1 evidence) that reviewed 30 randomized controlled trials and pooled the results of 3,463 patients (1). Many of these studies compared PRP to steroid and hyaluronic acid knee injections and found it to be superior. PRP was clearly shown to be a safe and effective treatment for knee arthritis. However, outside of the Regenexx corporate program, PRP is not yet covered by most insurance plans.

The most commonly used knee injection for arthritis is high-dose corticosteroids. However, we also have high-level evidence that these knee steroid shots eat up and destroy cartilage so that while the patient may get relief, the injection is a net negative for the patient (2). We also have research showing that knee steroid injections also increase the risk for adverse events once the patient needs a knee replacement (2-4). However, these injections are covered by insurance.

So, hopefully, you see the dilemma here for the doctor. If the patient has the financial means, once you explain this, the choice is clear, they will go with the PRP injection. However, if this is a Medicaid patient just getting by financially, this is a much tougher decision. So what is ethically required of the physician?

Beneficence vs. Non-maleficence

Beneficence is a huge and scary-sounding word used by bioethicists. Its modern origin in medicine comes from a seminal meeting in 1976 on the bioethics of research that created The Belmont Report (5). These bioethicists stated that:

“…beneficence, is the recognition that people are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts, or, more specifically, making it an obligation, to secure their well-being.”

Nonmaleficence means not harming or inflicting the least harm possible to reach a beneficial outcome. Or stated another way, nonmaleficence is the obligation of a physician not to harm the patient. Basically, the quote attributed to Hippocrates which is “First, do no harm” (6)

So while doctors have a responsibility to minimize the risk to the patient, they also have an ethical responsibility to do what’s best for that individual. Hence, if we use these ethical tests, it would be irresponsible to offer a knee arthritis patient a high-dose steroid injection as we know from a body of literature that while it may help symptoms, it will ultimately harm the patient. The Belmont Report and bioethics, in general, doesn’t include a “well it’s OK because their insurance company will pay for it” exemption. In fact, what we’re seeing in these bioethical documents is that doctors have a much higher responsibility to offer care that has the patient’s best interest front and center.

SI Joint Fusion

Another clear modern bioethical dilemma for spine physicians is SI joint fusion. Why?

First, SI joint fusion involves using x-ray guidance to insert a large screw through the SI joint, thus permanently destroying the articulation. The procedure is used to reduce instability and hopefully help with pain. The procedure can help SI pain based on a few studies done by the companies making one device (14-17).

However, the problem is that we know that the procedure is much higher risk than any injection we could offer the patient, with one review of insurance claims data showing a 16.4% complication rate (7). In addition, the concept of adjacent segment disease with any spinal fusion is well known and documented (8.9). That means that in these patients we can expect that for some, eventually their hips and their L5-S1 levels below and above the fused SI joint will wear out more quickly. Meaning that if we look at a 5 year plus horizon, in some patients there will be additional disability and healthcare spending caused by the SI fusion as some of these patients get L5-S1 fusions and hip replacements or other surgeries.

So why is this invasive and risky procedure offered? Many doctors cite the fact that insurance covers it.

If a patient has SI instability what is the evidence that much less invasive regenerative injections will help and allow the patient to keep an intact SI joint? We have two randomized controlled trials showing that dextrose prolotherapy and PRP will help and work better than a steroid shot (11,12). In addition, each of these procedures has been widely studied in many different applications and shown to have far fewer side effects and complications than SI fusion. Finally, given that the normal biomechanics of the SI joint will be preserved, it’s very unlikely that additional surgeries will be needed due to adjacent segment disease.

So based solely on the research and looking at the principle of beneficence, the doctor would have an ethical obligation to offer a patient with SI instability prolotherapy or PRP, as these are less invasive than fusion and shown to work. In fact, that responsibility would include talking a patient out of going with an SI fusion.

Is Insurance Coverage a Factor in Bioethics?

Again, where does insurance coverage enter into this ethical calculus? What if an SI joint fusion is covered and prolotherapy/PRP isn’t covered? Finding much on this topic in bioethics is not easy. This is a great quote from a 1991 JAMA article on the topic (13):

“…[In reviewing the concept of] expenditures for futile care and care that actually does patients more harm than good. Simply doing what will benefit the patient would actually save money as a fringe benefit.”

This is what the Regenexx corporate program is based on. How do we align the needs of protecting the patient with the needs of reducing cost? By allowing providers to offer the care that is the least invasive and most likely to help. In this case, allowing insurance coverage for the SI joint PRP injections to avoid a fusion does what’s best for the patient AND reduces cost for the employer.

How about if there is no Regenexx corporate program? I have yet to find a bioethical document (please ping me if you know of one) that says that it’s OK to adjust the ethical concept of beneficence because there coverage for a more risky treatment and none for a better treatment option.

Expanded Informed Consent?

The only way that I can see that the doctor would be able to avoid a serious medical ethics dilemma (and a possible malpractice case) by steering a patient toward covered care of a bad or “less good” solution is with expanded informed consent. That means that the doctor goes out of his or her way and documents that they have discussed with the patient that they are choosing a worse option for treatment based solely on insurance. That would include not only a written document but a documented extensive discussion back and forth with the patient. That would also require the patient to acknowledge in writing that this conversation took place and that they are choosing the worse option solely because it’s covered.

The upshot? I can find no way that medical bioethics would allow for steroid injections in knees or SI joint fusions as part of routine care given that there are better options with high-level research support. However, despite this, these procedures remain common. The question we need to ask ourselves is, why?

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References:

(1) Migliorini F, Driessen A, Quack V, Sippel N, Cooper B, Mansy YE, Tingart M, Eschweiler J. Comparison between intra-articular infiltrations of placebo, steroids, hyaluronic and PRP for knee osteoarthritis: a Bayesian network meta-analysis. Arch Orthop Trauma Surg. 2020 Jul 28. doi: 10.1007/s00402-020-03551-y. Epub ahead of print. PMID: 32725315.

(2) McAlindon TE, LaValley MP, Harvey WF, et al. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA.2017;317(19):1967–1975. doi: 10.1001/jama.2017.5283

(3) Wijn SRW, Rovers MM, van Tienen TG, Hannink G. Intra-articular corticosteroid injections increase the risk of requiring knee arthroplasty. Bone Joint J. 2020 May;102-B(5):586-592. doi: 10.1302/0301-620X.

(4) Richardson SS, Schairer WW, Sculco TP, Sculco PK. Comparison of Infection Risk with Corticosteroid or Hyaluronic Acid Injection Prior to Total Knee Arthroplasty. J Bone Joint Surg Am. 2019 Jan 16;101(2):112-118. doi: 10.2106/JBJS.18.00454.

(5) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. [Bethesda, Md.]: The Commission, 1978.

(6) Harvard Health Publishing. First, do no harm. https://www.health.harvard.edu/blog/first-do-no-harm-201510138421 Accessed 4/1/21.

(7) Schoell, K., et al., Postoperative complications in patients undergoing minimally invasive sacroiliac fusion. Spine J. 2016 Nov;16(11):1324-1332. doi: 10.1016/j.spinee.2016.06.016.

(8) Saavedra-Pozo FM, Deusdara RA, Benzel EC. Adjacent segment disease perspective and review of the literature. Ochsner J. 2014;14(1):78–83. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3963057/

(9) Zhong ZM1 Deviren V, Tay B, Burch S, Berven SH. Adjacent segment disease after instrumented fusion for adult lumbar spondylolisthesis: Incidence and risk factors. Clin Neurol Neurosurg. 2017 May;156:29-34. doi: 10.1016/j.clineuro.2017.02.020.

(10) Tobert DG, Antoci V, Patel SP, Saadat E, Bono CM. Adjacent Segment Disease in the Cervical and Lumbar Spine. Clin Spine Surg. 2017 Apr;30(3):94-101. doi: 10.1097/BSD.0000000000000442.

(11) Singla V, Batra YK, Bharti N, Goni VG, Marwaha N. Steroid vs. Platelet-Rich Plasma in Ultrasound-Guided Sacroiliac Joint Injection for Chronic Low Back Pain. Pain Pract. 2017 Jul;17(6):782-791. doi: 10.1111/papr.12526.

(12) Kim, W.M., et al., A randomized controlled trial of intra-articular prolotherapy versus steroid injection for sacroiliac joint pain. J Altern Complement Med, 2010. 16(12): p. 1285-90.”

(13) Veatch RM. Medicine and Money: A Study of the Role of Beneficence in Health Care Cost Containment. JAMA. 1991;265(19):2588. doi:10.1001/jama.1991.03460190168041

(14) Darr E, Cher D. Four-year outcomes after minimally invasive transiliac sacroiliac joint fusion with triangular titanium implants. Med Devices (Auckl). 2018;11:287–289. Published 2018 Aug 29. doi:10.2147/MDER.S179003

(15) Duhon BS, Cher DJ, Wine KD, Kovalsky DA, Lockstadt H; SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Global Spine J. 2016;6(3):257–269. doi:10.1055/s-0035-1562912

(16) Duhon BS, Bitan F, Lockstadt H, et al. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:13. Published 2016 Apr 20. doi:10.14444/3013

(17) Whang P, Cher D, Polly D, et al. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. Int J Spine Surg. 2015;9:6. Published 2015 Mar 5. doi:10.14444/2006