Recap

This is part 4 of a multi-part post walking through an appeal of a coverage denial for Adalimumab level testing. Here we construct an appeal letter based on our previous findings.

Writing the Initial Appeal

Let's now walk through the process of writing an appeal letter for the adverse coverage decision. As detailed in the denial letter itself, we can either write a letter and send it to the provided address, or fill out a complaint form supplied by Aetna. We'll go through the process of writing our own letter here, since we'll have a lot more to say than will fit on the form anyway, and it'll also allow us to organize the appeal as we see fit.

Absurdity

Aetna comically provides a box on their appeal form, capable of containing 2 to 3 sentences at most, which is meant to serve as a space for a patient to explain their appeal. Unlike insurers, we don't have the luxury of supplying an explanation of the form "I'm right because all the evidence agrees with me! Here's a list of sources." as consumers and expecting it to work, so we're going to need more room than that.

Denial Appeal Checklist

Before sitting down to write the letter, we should make sure we have all our ducks in a row.

**Figure 1.**
Look to nature for guidance.

Here's a summary of what we should have on hand given our previous work:

Understanding of what services were denied, explicitly.
Understanding of the denial rationale, if any exists, explictly.
Scientific or contextual evidence that offers a counterpoint to the rationale provided by the insurer, or that otherwise provides an argument for overturning the denial.

With this information prepared, we should write a letter that does the following:

Summarizes the coverage/service situation.
Explicitly states all ancillary data necessary for the insurer to respond and act, such as: the plan name and member id, the claim number, the denied service codes, the date of original care, the date of initial denial, contact information, etc.
Addresses and debunks the denial rationale point by point, providing explicit evidence to support all claims.
Requests an overturn of the decision based on the evidence and benefits contract.
Requests a written response as early as possible, and summarizes the legal requirements for timely responses¹.

Without further ado, here's an attempt at an appeal letter based on what we discovered in our research into the denial:

Mike Last Name
Address Line 1
Address Line 2
Address Line 3

05/14/2022

Plan Name: Managed Choice Open Access
Plan Sponsor: Name of Sponsor, if applicable.
Plan Sponsor Account Number: Sponsor Account Number, if applicable.
Member ID: Member ID
Case Number: Claim or Case ID
Service Date: 01/05/2022
Denial Date: 04/22/2022

Attention: Aetna Life Insurance Company

I’m appealing your company’s decision to deny coverage for a therapeutic drug assay to determine levels of Adalimumab in my bood (coded as CPT 80154) that I received on 01/05/2022. The claim is labeled in your denial letter as having a Case Number of Case Number. The reason listed for the denial on your denial letter is that the service is experimental or investigational in nature, and is not indicated or proven to be effective for treatment of my condition (Crohn's Disease). However, I've read my plan documents carefully, and all provided rationale and material referenced in your denial letter, and I believe this determination is inappropriate. I'll outline below why this is so, and provide a more detailed account of, and rebuttal to, your provided rationale.

It is clear that the denied service should be covered according to my plan benefits contract. First of all, the denied service is an "Eligible Health Service" as dictated by the plan, because it falls under the definition of "Physician Services" (see pages 1 and 15). Furthermore, coverage for this service would not go beyond any limits set forth in the Schedule of Benefits, and we will show below that the service does not meet any of the criteria described in the "Exclusions and Limitations" section of the plan. With all this established, the plan has an obligation to pay for the service as per page 1 of the benefits contract.

No preauthorization requirements exist in the plan for this service, and the service in question is "Medically Necessary" as the term is defined on pages 8 and 94. The peer-reviewed scientific evidence (which we'll outline below) clearly shows that the denied service is generally accepted by the relevant medical community (gastroenterology) to be effective in the context in which the service was ordered, not primarily a matter of convenience for any party, and the only existing approach to achieve equivalent therapeutic benefits (therefore no cost comparisons to equivalent or alternative treatments as dictated in the plan could even be made). Furthermore, the use of the service in this context is indicated as clinically appropriate based on it's context (e.g. it's frequency and extent).

While your denial rationale suggests the service could be considered "Experimental or Investigational" (as you define the terms on page 91), each piece of evidence from your Clinical Policy Bulletin that you cite in the denial letter to support that claim is either outdated, irrelevant, or does not establish this suggestion, as we explain in the following paragraph.

Your clinical policy bulletin for Adalimumab references three things that supposedly support the claim that "Clinical studies have not proven that [Adalimumab level testing] is effective for treatment of [Crohn's Disease]". Those are:

A study by Chiu et. al. from 2013.
A study by Mahil et. al. from 2013.
The statement "Furthermore, the Product Insert of Humira (adalimumab) does not mention Anser ADA and monitoring of drug level."

(See the "Background" section, subsection "Drug Level Monitoring and Anser ADA", in the CPB for where these statements occur.) These statements do not support your denial rationale, for the following reasons:

Both studies referenced are from 2013, and it is 2022. Lots of science happens in 9 years. In particular, many studies whose conclusions precisely contradict the claim have been performed since 2013.
The second paper studies level testing in patients with psoriasis. There is no apriori or proven reason for why the effectiveness of adalimumab level testing should be the same in treating all conditions, so this study has no bearing on whether or not Adalamumab level testing is effective for treating Crohn's Disease.
The third bullet point is an anecdote, related to a particular product choice of a for-profit corporation trying to maximize it's shareholders' stock values, and has no scientific or medical bearing on the claim of effectiveness at hand.
Both studies referenced conclude that level testing for adalimumab does appear to be useful, in the sense that it correlates with remission and treatment response. While they may not have proven that level testing adalimumab is effective for the treatment of Crohn's disease, their existence certainly doesn't show that other studies have not proven the effectiveness. In fact, if anything, these studies do provide evidence for effectiveness (perhaps just not sufficient evidence to prove it).

Finally, while it may not have been the case in 2013, which is when the studies referenced in your CPB are from, it is completely clear that now there is enough outcome data from controlled clinical trials published in peer-reviewed literature to validate the safety and effectiveness of the service for treating Crohn's Disease. We describe some of this body of work in the following bullet points:

Gonczi et. al. (https://pubmed.ncbi.nlm.nih.gov/28789636/) A population of patients with Crohn's Disease and Ulcerative Colitis were monitored to study the prevalance and frequency of the occurrence of anti-adalimumab antibodies development, and loss of clinical response to adalimumab. The authors concluded that the development of anti-adalimumab antibodies, and the need for dose intensification were frequent during adalimumab therapy, and support the selective use of drug level monitoring in IBD patients treated with adalimumab.
Papamichael et. al. (https://pubmed.ncbi.nlm.nih.gov/30689771/) Serum adalimumab concentrations and antibodies to adalimumab were measured among patients with Crohn's Disease split into two cohorts, some of whose adalimumab and adalmimumab antibody levels were proactively monitored to inform treatment, and others who were only monitored reactively (after loss of response). The long term outcome, and likelihood of treatment failure via adalimumab, were compared across these cohorts. Analyses showed that at least one proactive monitoring was independently associated with a reduced risk for treatment failure, and the authors concluded that adalimumab may be associated with a lower risk of treatment failure compared with standard of care in patients.
Assa et. al. (https://www.gastrojournal.org/article/S0016-5085(19)41000-7/fulltext) Serum adalimumab concentrations were measured among pediatric patients with Crohn's Disease split into two cohorts, some of whose adalimumab and adalmimumab antibody levels were proactively monitored to inform treatment, and others who were only monitored reactively (after loss of response). The long term outcome, and likelihood of a certain type of remission, were compared across these cohorts. The authors found that proactive monitoring of adalimumab levels, and the proactive adjustment of doses and intervals that facilitates, resulted in significantly higher rates of corticosteroid-free clinical remission than plain reactive monitoring (measuring trough concentration after loss of response).
Mitrev et. al. (https://pubmed.ncbi.nlm.nih.gov/29027257/) Conclusions of studies on the role of adalimumab level monitoring in IBD patients were aggregated, to produce the consensus understanding of how useful such monitoring is for optimizing treatment. 25 experts collectively conducted a literature review, and voted anonymously to produce consensus statements on therapeutic adalimumab level monitoring. Only statements with 80% agreement or more were accepted. The authors concluded that consensus statements deem therapeutic drug monitoring to be effective in optimising anti-TNF agents, including adalimumab, to treat IBD, especially in situations of treatment failure.

Collectively, these works make clear that the consensus opinion among gastroenterology experts, based on peer reviewed literature in the field, is that level testing for adalimumab is for all intents and purposes understood and proven to be effective in treating Crohn's Disease.

This concludes my rebuttal of your denial rationale as it pertains to my benefit contract, the CPB, and the scientific literature. Please let me know via email or phone (provided below) if you need any other information to review my case.

I look forward to rectifying this outstanding coverage issue in a timely manner, and I would appreciate a response as soon as possible, as this matter has implications for my well being. As you are aware, there are legal limits stipulating your required response times, and in this particular case the maximum allowable turnaround is 30 days from now.

Sincerely,
Mike Last Name
Phone Number
Email

In case it is useful, here's the same letter written as a more generic template:

[Name]
[Address]

[Today's Date]

Plan Name: [Plan Name]
Plan Sponsor: [Plan Sponsor, if relevant]
Plan Sponsor Account Number: [Plan Sponsor ID, if relevant]
Member ID: [Member ID]
Case Number or Claim ID: [Case Number or Claim ID]
Service Date: [Date of Original Care/Service]
Denial Date: [Date on Denial Correspondence]

Attention: [Insurance Company]

I’m appealing your company’s decision to deny coverage for [Description of Denied Service] that I received on [Care Date]. The claim is labeled in your denial letter as [ID for the Claim]. The reason listed for the denial on your denial letter is [Summary of Denial Reason Provided]. However, I've read my plan documents carefully, and all provided rationale and material referenced in your denial letter, and I believe this determination is inappropriate. I'll outline below why this is so, and provide a more detailed account of, and rebuttal to, your provided rationale.

[Detailed Summary and Rebuttal of Denial Rationale]

Please let me know via email or phone (provided below) if you need any other information to review my case.

Sincerely,
[Name]
[Phone Number]
[Email]

Outro

That sums up the first phase of this appeal journey. Within 30 days, I should hear back about a coverage decision, which will almost surely be another denial ². At that point, we'll move on the next phase of the appeal lifecycle.

If you are dealing with your own coverage denials and need help navigating the process, let us know. We're actively working on building free automated tools to help consumers go through complex processes like these with little effort, but, as you can imagine, it's a bit complicated to handle all of these processes in an automated fashion. In the meantime, we want to help you with these processes manually and take as much off your plate as we can. We'd be happy to meet you virtually or in person to discuss and work on your appeal, for free.

Feel free to reach out to me personally at mike@persius.org if you can use any help.

Thanks for reading!

If the lack of coverage for the service poses an urgent threat to your health, insurers are required to expedite their responses upon request. The exact legal requirements for response timelines from insurers are detailed here. ↩
That's to be expected after a first appeal; after all, insurers are typically for-profit companies financially accountable to their shareholders, whose aim is to maximize profits. It makes sense that they'd do everything they can to collect more premiums while paying for as little coverage as possible. There's no downside to denying for them, except the exceedingly rare lawsuit and potential punitive damages. Typically, worst case scenario is they are forced to provide coverage, so they have nothing to lose in attempting to deny as long as it is feasible to do so without repurcussions. ↩

Recap

Writing the Initial Appeal

Denial Appeal Checklist

Outro

Footnotes