This is what CaseWhy Appeals writes for a case like this one; your letter uses your facts and your notice's rule.
September 27, 2026
Sunrise Medicare Advantage — Part D Coverage Determinations, PO Box 5501, Tampa, FL 33601 — Fax (813) 555-0198
RE: Requesting a coverage determination, including a formulary or tiering exception, under 42 CFR § 423.566 and § 423.578 — Dorothy Sample, plan member ID ••••DEMO, denial dated 2026-08-10, Drug not on the plan's formulary
On 2026-08-10, your drug plan denied the item or service described below. The stated reason was: "This drug is not included on our list of covered drugs."
I am appealing the denial of coverage for the requested prescription drug on the grounds that your drug plan failed to apply the governing exceptions procedures required by 42 CFR § 423.578(b). Your plan's notice stated only that the drug is not on the formulary, but this does not address whether the drug meets the criteria for a non-formulary exception. Under 42 CFR § 423.578(b), your plan must establish and maintain exceptions procedures for off-formulary drugs and must grant an exception whenever it is determined that the drug would be covered but for the fact that it is off-formulary. The mere absence of a drug from the formulary does not constitute a final coverage determination; rather, your plan is required to evaluate whether the prescriber's supporting statement demonstrates that the covered formulary alternatives would not be as effective, would cause adverse effects, or both.
The regulatory framework at 42 CFR § 423.578(b)(5) requires your plan to evaluate the prescriber's statement against specific clinical criteria: whether all covered Part D drugs on the formulary for the same condition would be less effective or cause adverse effects, whether formulary alternatives have been ineffective or are likely to be ineffective based on sound clinical evidence, or whether formulary alternatives have caused or are likely to cause adverse reactions. Your plan's denial did not address these required evaluation criteria or explain how the prescriber's supporting statement was assessed against them. By failing to conduct this evaluation and instead simply citing the drug's absence from the formulary, your plan did not comply with the exceptions procedures mandated by 42 CFR § 423.578(b).
Additionally, 42 CFR § 423.578(b)(2) requires that your plan's exceptions criteria include a process for gathering and comparing applicable medical and scientific evidence on the safety and effectiveness of the requested non-formulary drug with formulary alternatives. Your denial provides no evidence that such a comparison was performed or that your plan considered the clinical evidence supporting the prescriber's recommendation. The regulatory requirement at 42 CFR § 423.578(b) establishes that formulary status alone is not a sufficient basis for denial when an exceptions request has been submitted; your plan must instead conduct the substantive clinical review that the regulation requires.
The facts as I understand them:
I have already tried a formulary drug for this condition that didn't work or caused a problem.
The prescriber has not sent the plan a written statement about why the non-formulary drug is needed.
The plan's notice said the drug isn't on its formulary at all, rather than citing a prior-authorization or step-therapy rule.
Requesting a coverage determination, including a formulary or tiering exception, under 42 CFR § 423.566 and § 423.578
I understand that for a formulary or tiering exception, my prescriber's written supporting statement is required before this request can be granted.
Enclosures:
Physician letter (to follow)
Signed by the enrollee.