Tuesday, 12 Nov 2019

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Writing Effective Appeal Letters

The right drug for the right patient isn’t quite as easy as it should be.

Not all headaches will need or respond to aspirin and no two patients are alike. Hence, not all patients will do well with the same or limited choices of therapy.

Simply and smartly, a plan of care needs to be: 1) the best therapy (offering the right balance of efficacy and safety); 2) acceptable and manageable; and 3) affordable. The best or right therapy needn’t be the newest, most expensive or the most available. Instead, a chosen therapy should have evidence-based efficacy and safety and, if possible, regulatory approval. Regulatory approval has the built-in benefit of requisite studies, optimal dosing, guidance on how to maximize drug safety and who should not receive such therapy.

Unfortunately, the simple has burgeoned into the complex. Regrettably, pharma, insurers and benefit managers run amok with profit algorithms programmed to limit costs by routine denials and reflex paperwork designed to delay, deflect or deny that which is rightfully needed, justified and doable.

While some point to greed, capitalism, malevolent opportunism, divide-and-conquer tactics or big business bullying of the patient and practitioner, I prefer to just call it all a special kind of stupid and a misuse of my time and experience. I don’t mean to be crass or rash in my judgment, but how smart is it when:

  • You’re asked to fill out paperwork and get pre-approval for a 30 year old drug (methotrexate) that costs pennies a day?
  • When patients use to pay a $5 copay for hydroxychloroquine, but now have to pay $200-300 for the same prescription?
  • When Insurer A requires you use Enbrel before Humira; Insurer B requires you prescribe Humira before Cimzia; Insurer C requires you prescribe Cimzia before Enbrel and Insurer D requires you use Enbrel, Humira, and Remicade before they will allow the patient to receive Simponi, Actemra, Orencia, Rituxan or Xeljanz?
  • Insurers prefer 1 or 2 drugs over the 10 proven to be equally efficacious and have the same regulatory indications for use?

The right drug for the right patient isn’t quite as easy as it should be.

Not all headaches will need or respond to aspirin and no two patients are alike. Hence, not all patients will do well with the same or limited choices of therapy.

Simply and smartly, a plan of care needs to be: 1) the best therapy (offering the right balance of efficacy and safety); 2) acceptable and manageable; and 3) affordable. The best or right therapy needn’t be the newest, most expensive or the most available. Instead a chosen therapy should have evidence based efficacy and safety and, if possible, regulatory approval. Regulatory approval has the built in benefit of requisite studies, optimal dosing, guidance on how to maximize drug safety and who should not receive such therapy.

Unfortunately, the simple has burgeoned into the complex. Regrettably, pharma, insurers and benefit managers to run amok with profit algorithms programmed to limit costs by routine denials and reflex paperwork designed to delay, deflect or deny that which is rightfully needed, justified and doable. While some point to greed, capitalism, malevolent opportunism, divide and conquer tactics or big business bullying of the patient and practitioner, I prefer to just call it all special kind of stupid and an important misuse of my time and experience. I don’t mean to be crass or rash in my judgement but how smart is it when:

  • You’re asked to fill out paperwork and get pre-approval for a 30 year old drug (methotrexate) that costs pennies a day?
  • When patients use to pay a $5 copay for hydroxychloroquine, but now have to pay $200-300 for the same prescription?
  • When Insurer A requires you use Enbrel before Humira; Insurer B requires you prescribe Humira before Cimzia; Insurer C requires you prescribe Cimzia before Enbrel and Insurer D requires you use Enbrel, Humira, and Remicade before they will allow the patient to receive Simponi, Actemra, Orencia, Rituxan or Xeljanz?
  • Insurers prefer 1 or 2 drugs over the 10 proven to be equally efficacious and have the same regulatory indications for use?

Problem #1. Negotiated formularies. The prescriber and patient have to live with the rules of your insurance program. Since not all insurance programs cost the same or administer benefits the same, the rules are going to be dramatically different. Sadly, our patients think their physician understands the differences and nuances of these insurance programs – we don’t. Most of us are lucky enough to have office staff who are better equipped to handle questions or provide advice on such matters. The major issue in “preferred” or “tiered” formularies is the issue of contracted costs and rebates.

Drug manufacturers have an established market price, but when selling the drug to pharmacy managers (who issue drug benefits on behalf of the insurer), bulk sales allow for discounts. Moreover, discounts are enhanced with large buyers through a system of “rebates”. For example, if a drug has a list price of $40,000 per year, it can be sold at volume discount for $5-10,000 less per person per year. Rebates are applied for the large buyers who will place that drug at the top of the “preferred” drug list. What happens to the financial savings with bulk discounts and rebates? Lord knows, but there is little benefit the cost is passed on to the patient.

Problem #2 Cost-containment. This becomes the excuse for making you work harder, with paperwork, phone calls and idiot approvals for all drugs – especially drugs that are expensive, used in high volume or off-label.

Problem #3 Off-label use. This is the big benefit gotcha. They don’t have to approve your request for rituximab for severe myositis or intractable ITP, and you should know that since this expensive effective drug is only approved for use in CD20+ B cell lymphoma, rheumatoid arthritis and just recently granulomatous polyangiitis (GPA). Sorry Charlie – the same goes for lupus, JIA, interstitial lung disease, multiple sclerosis and IBD. I personally like the challenge of off-label prescribing; this is where smart, informed physicians should excel. Regulatory approval is intended to control how drugs are marketed and sold – not to restrict how medications are prescribed and used to treat medical conditions, many of which are uncommon enough to not have an “approved” drug. As stated before, there are benefits to a drug being FDA approved. But there are no benefits when treating orphans like Still’s disease, scleroderma, Churg-Strauss (EGPA) and Takayasu’s arteritis.

Solution: The best defense is a good offense! You need the tools necessary to streamline the drug acquisition process. This may include dedicated office personnel for drug approvals – but this is a costly, uncompensated expenditure for any medical operation. Alternatives include the use of specialty pharmacies (to apply, review benefits, apply discount cards/plans, ship and renew), manufacturer assistance programs or an automated way of generating the effective appeal letter. The ACR offers off-label use letter templates and other insurance advocacy tools for members (see here).

This article ends with an example appeals letter that is yours to copy, modify, improve, and use to generate appeals (or nonformulary request) letters.

Sage advice on appeal wisdom is provided below from a two experienced rheumatologists and legislative leaders (Drs Cohen, Wasner, Thomas). Collectively their insight, wisdom, and wits could cause medical directors to retire, claims assistants to cry, and CMS to shut down.

Stanley Cohen, MD (Dallas, TX)

In my experience, the appeal letter results in a peer-to-peer encounter which is successful in obtaining the drug about two-thirds of the time. Of course, this depends on whether you are lucky enough to get an educated MD, preferably a rheumatologist. What is disappointing is the total lack of acknowledgement by insurers of the ACR's efforts a few years ago to delineate various rare diseases wherein non-approved therapies may be appropriate.They hide behind the regulatory approval as you point out. The ultimate irony is that with the insurers we have a shot, but with CMS we have none.

Cody Wasner, MD (Portland, OR)

The epigram for my contribution could be "No matter how cynical I am, when it comes to insurance companies I’m never cynical enough."

From my point of view your frustration level will rise and your heart will be broken if you think that scientific logic, scientific evidence, government approval or any of the ethical or moral standards that we use in taking care of patients has any applicability in this situation. The frame that the insurance company is using is different from the ones we use. It is a business model and a profit motive frame. Of course the rules and requirements they give to us for drug selection and use don't quite make sense.

They are hearing voices; little voices whispering words like “profit margin” and "market rebate” (a semi-legalized form of kickbacks) in which the pharma companies lower their wholesale prices in exchange for increased usage. In my opinion, over 90% of their restrictions and biases are profit based.

My advice would be to spend less time trying to document the elegant clinical subtleties of your medical decisions (which they probably can't understand) and instead venture into their reality, driven by finance. They don't want patients to get sick, or die because of their restrictions (they could get sued), or leave the plan (bad publicity). Mention that you know the case in detail and that your serial physical exams and psychological interactions with the patient are what you based your decision-making on. Your decision is drug X is most appropriate, and that to use anything less would put the patient in danger of a bad outcome. You might also mention that you would be forced to support the patient in court if a bad outcome would result from withholding this treatment. Also continue to appeal if rejected and always put cc: to the patient.

Donald Thomas, MD (Greenbelt, MD)

This past year has been crazy with preauths/appeals. A very helpful thing I found to do =

WRITE DIRECTLY TO THE CEO OF THE INSURANCE COMPANY

I did this with:

AETNA ... they were denying biologics for no recent TB testing after a biologic switch even though one was done within previous year, thus impeded the patient getting the necessary medicine. I wrote CEO to complain, and said, "maybe I should be order a very expensive Quantiferon test more regularly"?  Immediately I was contacted by AETNA about it. I've never had another similar problem.

Carefirst... they sent us an 8 page preauthorization for for Humira for RA with over 300 potential areas to fill out... I sent a letter to the CEO and got a personal phone call within a week with 3 of their representatives from Cardinal, Medical Director, and someone else from corporate. They listened to our recommendations for changes and promised to improve.

Example Appeal Letter – please note that my EMR is programed to provide multiple answers for those areas below denoted by (PARENTHESES.EXAMPLES). You can modify/program your EMR to write such appeal letters with great specificity and accuracy.

(Your Arthritis Clinic)
Address 1
Address 2
Office phone #
Office fax #

Date: (TODAYS DATE)

FORMULARY REQUEST

Re: (PatientName) DOB: (birthdate)

To whom it may concern; °

I am writing on behalf of my patient listed above, who carries a diagnosis of (LISTARTHRITIS_DIAGNOSIS), last seen (lastvisitdate) and who is regularly evaluated and treated by me in the (YOURARTHRITIS CLINIC). I am writing to request that you approve the issuance of the restricted medication (LISTAPPEAL DRUGS). Currently this patient is doing (GOOD-FAIR-POOR) and requires this therapy to control (his/her) condition, maintain current work productivity and improve (his/her) ability to perform activities of daily living.

Requested medication: (LISTAPPEAL DRUGS)
Dose & Schedule: °(eg, 50 mg sc every other week)
Duration of therapy: (12 months)

Indication: This medication is needed to adequately treat this patients: (LISTARTHRITIS_DIAGNOSIS).

Justification of Nonformulary Item: (EXCLUSION REASONS FOR UNWANTED RX, PLUS REASONS WHY REQUESTED ITEM IS NECESSARY)

Alternatives Previously Tried/Failed: (PREVIOUSLY TRIED/FAILED DMARDs, BIOLOGICS, NSAIDs, STEROIDs, NonRx MEASURES)

This patients medical diagnoses and current medications are listed below.
(LIST CURRENT Diagnoses)
(LIST CURRENT Medications)
(LIST CURRENT Allergies)

I strongly urge you to approve this medication as I feel that such a change is medically indicated, cost effective (given the above information) and is in the patients best interest.

OPTIONAL STATEMENTS

  • To not provide this much needed, medically indicated and evidence-based therapy would be counter to current standards of care and would be medical malpractice in my opinion.
  • This patient has previously tried and failed the therapy you have requested/proposed (PROVIDE DATES).
  • The patient has been doing well on the drug you are inexplicably denying and has been successfully treated with (LISTAPPEAL DRUG) for the past (Duration of APPEAL DRUG USE).
  • This patient has a rare disorder for which there are no FDA approved therapies or large clinical trials done by pharmaceutical companies with a financial stake in the success of a drug for a popular or common disorder. As such, you will find appended to this letter, citations from the medical literature attesting to the efficacy and safety of (LISTAPPEAL DRUG) when used to treat (PATIENTS DIAGNOSIS).

Please contact me at your earliest convenience should you have questions about this patient or this medication request.

John P. Smith, MD
Title
Clinic/Affiliation

 

Below is an example of how this reads

Arthritis Care & Research Center
9900 N. Central Expwy, Ste 550
Dallas, TX 75231
ph. 214-373-4321 fax 214-373-4326

December 15, 2015

NEW FORMULARY REQUEST

Re: Ms. Josephina Sample DOB: 11-11-1941

To whom it may concern; °

I am writing on behalf of my patient listed above, who carries a diagnosis of Severe, Seropositive Rheumatoid arthritis, last seen 12-07-2015 and who is regularly evaluated and treated by me in the Arthritis Care & Research Center. I am writing to request that you approve the issuance of the medication Xeljanz (tofacitinib). Currently this patient is doing poorly and requires this new therapy to control her condition, maintain current work productivity and improve her ability to perform activities of daily living.

Requested medication: Xeljanz (tofacitinib)
Dose & Schedule: 5 mg bid
Duration of therapy: 12 months

Indication: This medication is needed to adequately treat this patients: pain, Severe, seropositive Rheumatoid arthritis.

Justification of Nonformulary Item: Lack of response to numerous NSAIDs, over-reliance on current steroids for clinical benefit, and no response (or toxicity) to Methotrexate, Plaquenil, Gold, sulfasalazine and other Biologic DMARDs

Alternatives Previously Tried/Failed: multiple NSAIDs, °prednisone, Methotrexate, Plaquenil, sulfasalazine, Arava, Enbrel, Humira, azathioprine, and Kineret

This patients medical diagnoses and current medications are listed below.
DIAGNOSES: Rheumatoid arthritis, Fibromyalgia, COPD, Neuropathy, Osteopenia; hyperlipidemia
MEDICATIONS: Prednisone 10 mg qd, Mobic 15 mg qd, Kineret 100 mg qd, NIASPAN 1 tab qd; Gabapentin 300 mg qhs; vitamin D3 2000 IU qd; Ergocalciferol 50,000 IU take i po qweek.
ALLERGIES: Arava causes N/V; gold causes rash; Ultram causes Stevens Johnson syndrome; aspirin; Cymbalta causes N/V

I strongly urge you to approve this medication as I feel that such a change is medically indicated, cost effective (given the above information) and is in the patient’s best interest. Please contact me at your earliest convenience should you have questions about this patient or this medication request.

John J. Cush, MD
Director of Clinical Rheumatology, Baylor Research Institute
Professor of Medicine and Rheumatology
Baylor University Medical Center

Disclosures: 
The author has no conflicts of interest to disclose related to this subject
Dr. Cush is the Director of Clinical Rheumatology at the Baylor Research Institute and a Professor of Medicine and Rheumatology at Baylor University Medical Center in Dallas, TX. He a Professor of Clinical Medicine at the University of Texas Southwestern Medical School.
 
Dr. Cush is the Executive Editor of RheumNow.com and also Co-Edits the online textbook RheumaKnowledgy.com. 
 
Dr. Cush's research and interests include novel drug development, rheumatoid arthritis, spondyloarthritis, drug safety, pregnancy and Still's disease/autoinflammatory syndromes. He has published over 140 articles and 2 books in rheumatology.
He can be followed on twitter: @RheumNow.

Rheumatologists' Comments

BRAVO Jack! For all of us providing the best clinical care possible, this becomes an all-too-frequent task. Moreover, as a rheumatology fellowship director, I have come to realize this is a Systems Based Practice competency at its foremost. I"m gong to adopt this into our curriculum, and recommend it to my colleagues training the next generation of rheumatologists