Did Your Insurance Deny Coverage of Oral Vancomycin for PSC? Here’s How to Prepare Your Appeal (TEMPLATES INCLUDED)

Oral vancomycin can be extremely difficult for PSC patients to access. It’s quite common that insurance companies deny coverage—even if the patient has been taking oral vancomycin for years! (There are some political motives behind this, which you can read more about here.)

In today’s post, I’m going to share with you exactly how to prepare an appeal if your insurance company has denied coverage of oral vancomycin for your or your loved one’s PSC.

First, What is an Insurance Appeal?

Never forget that as the patient, you have power. If your insurance denies coverage of oral vancomycin for PSC, you don’t have to accept that as the answer. You can send in an appeal and fight for you access to oral vancomycin.

By sending in an appeal to your insurance company, you are:

• Telling them you disagree with their decision,

• Providing reasons why they should cover it, and

• Requesting that they change their decision.

And buckle up, because there is A LOT of evidence why insurance could cover it. Let’s dive into that now!

What Documents Will You Need in Your Appeal Package?

It may take some time to prepare your appeal package. That’s okay. Take a deep breath. My fellow PSC advocates and I have gathered all the documents, templates, and supporting evidence you’ll need.

Below is a list of required and suggested documents you should include to create an effective oral vancomycin appeal. Further down, I’ll go into detail about each document.

1. Your personal appeal letter
2. A Letter of Medical Necessity, written and signed by your doctor
3. Published research papers that show oral vancomycin’s effectiveness in treating PSC
4. A Letter to the Editor of the Hepatology medical journal titled “Insurance Should Cover Oral Vancomycin for PSC”
5. A Support Statement, written by the American Association for the Study of Liver Diseases (AASLD)
6. Any appeal forms that your insurance company requires

Document 1: Your Personal Appeal Letter

The foundation of an effective appeal is a strong appeal letter. This appeal letter is a request for your insurance company to reevaluate their decision and cover oral vancomycin for your PSC. The purpose of your appeal letter is to provide evidence, reason, and data to prove why your insurance should cover oral vancomycin.

The three most important parts of an effective appeal letter are:

1. Data and test results that show how oral vancomycin has helped you
2. A background on PSC and oral vancomycin therapy, including the science behind why oral vancomycin works
3. A list of all research papers that show oral vancomycin’s effectiveness in treating PSC

Here is the template appeal letter for you to edit.

You MUST customize the parts highlighted in yellow to your unique situation. And please remember to remove the yellow highlights before you submit your appeal. Wherever it says “Insurer” please put your insurance name there. And of course, feel free to add anything else about your improved symptoms, test results, etc. that supports your case.

Disclaimer: Please remember that using this appeal template and following the process outlined in this post does not guarantee that your insurance will agree to cover oral vancomycin for PSC.

Remember that this appeal letter is a template. You MUST edit it to reflect your own test results, symptoms, and experiences. I’ve highlighted in bright yellow where you need to edit the template before sending it to your insurance.

Document 2: Letter of Medical Necessity

A Letter of Medical Necessity is a letter written by the physician who’s prescribing your oral vancomycin. Its purpose is to show your insurance that you have physician backing and support in accessing oral vancomycin.

A Letter of Medical Necessity should contain critical information, including:

• Your oral vancomycin dose
• Your oral vancomycin brand
• Your improved symptoms and test results
• The PSC ICD Code (this stands for International Classification of Diseases, and it helps healthcare/insurance workers to easily identify disease information).
• What could happen if the patient stops taking oral vancomycin (ie. liver damage, cirrhosis, etc).
• A final statement declaring it is medically necessary for the patient to continue taking oral vancomycin for continued health

Below is my own Letter of Medical Necessity template. You must edit the parts highlighted in yellow. Or, if your doctor has a different format, they’re welcome to write their own from scratch.

To save and edit this template, follow the same directions in the gray box above.

Document 3: Published Research Papers

Published research papers are some of the most crucial documents for you to include in your appeal package. Why? Because they show data and evidence showing oral vancomycin’s effectiveness in treating PSC.

Yes, there are 21 research papers cited in the appeal letter above. However, including the actual research papers themselves can only help your case. You want to give your insurance as much easy-access evidence as possible.

Below are three great papers you can print out and include in your appeals package. Please note, you do NOT have to include all of them. Pick and choose which one(s) you want to include.

1. Review Article: The Evidence that Vancomycin is a Therapeutic Option for Primary Sclerosing Cholangitis

This is the paper include in my annual prior-authorization submission to request another year of access to oral vancomycin for my PSC. It’s only 10 pages and you can download it here.

2. Open-Label Prospective Therapeutic Clinical Trials: Oral Vancomycin in Children and Adults with Primary Sclerosing Cholangitis

This is another great paper to include because it shows that oral vancomycin is effective in treating children as well as adults. It’s 11 pages long and you can download it here.

3. A Triple Blinded, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis: A Pilot Study

This paper is awesome because it shows that, in this pilot study, there were ZERO side effects or negative reactions from taking oral vancomycin for PSC. The “risk” of side effects is a common argument some physicians bring up, and insurance might, too. It’s 8 pages and you can download the paper here.

P.S. Did you know that I have an entire webpage dedicated to research papers and other resources on my website’s PSC Hub? Check out medical literature and resources here.

Document 4: Letter to the Editor

This Letter to the Editor (LTE) was written by Cynthia Buness—a prominent PSC and oral vancomycin advocate—and a handful of amazing, supportive physicians. The LTE was published in the medical journal Hepatology (which is run by the American Associated for the Study of Liver Diseases (AASLD).

If you want to read my in-depth article about what an LTE is and why this one is important, click here.

The two key pieces of information you need to know are that: 1) this LTE is titled “Insurance Should Cover Vancomycin for Primary Sclerosing Cholangitis” and, 2) because it was published in the AASLD’s journal, the AASLD is publicly supporting that insurance should cover oral vancomycin for PSC. This should help support your appeal package!

Document 5: AASLD Support Statement

The AASLD Support Statement is a required document. It is written in nice, neutral language, stating “Although there is not sufficient evidence to make a formal recommendation regarding the use of vancomycin for PSC, it should not be used as justification to restrict coverage of this treatment if a physician feels it is the right course of action.”

This is another public statement that the AASLD declares oral vancomycin for PSC should be covered by insurance.

Document 6: Insurance Appeal Forms

Your insurance company may require you to fill out their appeal forms. This may vary between insurance companies, so be sure to check your insurance’s website or give them a call to find out exactly what documents you might need to fill out.

These forms should also tell you whether your insurance prefers you to mail, fax, or email your appeal package.

2 Things You Should Do After Submitting Your Appeal

After you send in your appeal, it’s time to wait. But there are some things you can do in the meantime to help the PSC community.

1. Fill Out Our Google Form

My fellow advocates Cynthia Buness and Lorrie Williams have created a Google Form. We want to collect the information of every PSC patient who experiences an insurance denial.

In the future, we may send some of this information to the AASLD to show them how their biased Guidance has hurt the PSC community (because most of these insurance denials are a direct result from the AASLD’s Guidance, which you can learn more about here).

Perhaps if the AASLD sees the damage they’ve caused, they will actually do something to help the PSC community.

(Right now, the information submitted is only available to Cynthia and Lorrie. They are both advocates and mothers of children with PSC on oral vancomycin. Please email them at cynthia.buness@gmail.com or ddwilliams0906@gmail.com with any questions.)

2. Report on the System by Submitting this ProPublica Form

Have you heard of ProPublica? According to their website, ProPublica is, “An independent, nonprofit newsroom that produces investigative journalism with moral force.”

Essentially, they use investigative journalism to expose abuses of power and betrayals of the public trust in healthcare, government, and business.

As I’m writing this in February 2023, ProPublica is looking to report on the healthcare system by collecting stories of patients who have experienced health insurance denials. Hopefully if enough PSC patients fill this out, ProPublica may be inspired to investigate this issue we’re facing. (For example, read this recent article about an ulcerative colitis patient facing insurance issues.)

If my insurance denies my oral vancomycin, I will ABSOLUTELY be filling this out. Every time you share your story about trying to access oral vancomycin, you help pave the way for the PSC community.

The 1 Thing You Should Do IMMEDIATELY if Your Insurance Denies Your Appeal

If this happens, you’re now experiencing your second denial. I imagine you might be frustrated and, probably, a little scared.

Take a deep breath.

This is not the end of the road. There are still things you can do to try to get oral vancomycin for your PSC:

Go to CoverageRights.org. Click on your state. Find your next steps and do them.

These steps vary by state, so depending on where you live, your next step might be something like, “request a second level appeal” or “request an external review” or “file a complaint.”

Follow the instructions for your state. There should be links provided.

3 Ways to Access Oral Vancomycin for PSC Without Health Insurance

While you’re waiting for your insurance provider to respond to your appeal, you might need to pay for oral vancomycin out-of-pocket.

Here are three methods to look into:

1. CostPlus

Mark Cuban’s CostPlus Drug Company sells medications at a much more affordable rate. In fact, they don’t even take insurance, so it will all have to be out-of-pocket. You WILL still need a physician’s prescription.

Just go to the website, click on “Medications,” type in “vancomycin,” and type in your strength and quantity.

Please note: Their oral vancomycin capsule brand is Lupin. They currently do not carry ANI. From what I’ve seen within the PSC community, Lupin is often associated with positive results. (It also looks like they don’t carry the liquid Firvanq brand.) If you’re switching to Lupin from another brand, pay close attention to your symptoms and labs, and understand that not every brand works for every patient.

2. SingleCare Coupons, Especially When Used at Kroger-Owned Pharmacies

SingleCare is an awesome company that helps patients get discounts on medications. You can download the app, or, use the web version. Just type “vancomycin” in the search bar, fill out your strength and dose, and find a pickup pharmacy near you.

You can find a Kroger pharmacy near you (be sure the “pharmacy” box on the left is checked!) or see the entire list at Kroger’s pharmacy directory.

I’ve had multiple advocates tell me that when a SingleCare coupon is used at a Kroger-owned pharmacy (such as Harris Teeter, Fry’s, Pick’ N Save, and many others), prices tend to be cheaper than other pharmacies. Kroger might even cheaper than CostPlus, depending on your dose. I’ve been told that Kroger tends to be cheaper than CostPlus for the 250 mg capsules, but not for the 125 mg capsules.

Most importantly, I’ve been told that many patients have not had any issues getting ANI or Lupin generics through Kroger’s pharmacies. They appear to also carry the liquid Firvanq.

3. Explore Other Coupons

There are other medication-saving coupon companies, such as Pilly (which I use!), Visory Health, GoodRX, Optum Perks, Blink Health, and Walgreens RX Saver Finder.

It’s always smart to shop around to see what coupons and pharmacy combinations can get you the lowest price.

In Conclusion

I know it’s scary and disheartening when your insurance denies oral vancomycin for PSC. One of the biggest things I want you to take away from this post is that YOU ARE POWERFUL. YOUR VOICE MATTERS.

As PSC patients and patient advocates, we have the power to stand up to insurance companies and tell them they are wrong to not cover oral vancomycin. Insurance is supposed to cover off-label medications. (After all, urso is off-label for PSC and it’s usually always covered!)

So take another breath. Prepare your strong appeal package by following the steps above. You got this.