Formulary changes in U.S. plans: how to respond and appeal options

On a sleepy Tuesday, I walked into my neighborhood pharmacy expecting a routine refill and walked out holding a little slip of paper that said “non-formulary.” I stood in the parking lot doing that math we all do in a pinch—Can I afford this for a month? Is there a backup? Who do I call first? The moment felt small, but it opened a bigger question I’ve been meaning to unpack: when a health plan changes its drug list (the formulary) mid-year or re-tiers a medication so the price jumps, how do we respond calmly and effectively? Today I’m putting all the notes I wish I’d had in one place—equal parts diary and checklist.

When a refill suddenly costs triple

My “aha” came from noticing that not all “it’s not covered” messages mean the same thing. Sometimes the plan has removed a drug from the formulary. Other times it’s still covered but moved to a higher tier, or it now requires prior authorization (PA), step therapy (trying lower-cost alternatives first), or has a stricter quantity limit (QL). The pharmacy’s screen may not tell the whole story. That’s why my first call is to the plan (or I log in to my account) to see exactly what changed and on what date. A high-value early takeaway: name the change precisely—removal, tier change, new PA or step therapy—because each one points to a different fix.

  • Ask the pharmacist to read the rejection message verbatim (PA required, step therapy, NDC not covered, non-formulary, etc.).
  • Check your plan’s online formulary and the most recent Explanation of Benefits (EOB) to confirm the drug’s tier and any new restrictions.
  • Write down dates: when the pharmacy tried to fill, when you called the plan, and when you were told the change took effect. Appeals live and die on timelines.

Figure out what kind of plan you have

Not all appeal rights are identical, and knowing your plan type keeps you from chasing the wrong process:

  • Employer or individual/Marketplace plans (ACA/ERISA): You typically get an internal appeal and, if needed, an independent external review by a third party. See the official HealthCare.gov appeals overview and the external review page for timelines and eligibility.
  • Medicare drug coverage (Part D, including MA-PD): There’s a defined path—coverage determination → redetermination (appeal) → independent review—plus rules for mid-year formulary changes and temporary “transition” supplies. See CMS Part D coverage determinations and the Part D manual’s formulary and transition sections in Chapter 6.
  • Medicaid: Appeal rules are state-specific, and many states allow a “fair hearing.” Your plan card or member portal lists the first appeal step; your state Medicaid site lists deadlines.

What actually changed and why that matters

Plans change formularies for a few common reasons: safety alerts or withdrawals, new generics (re-tiering the brand), negotiations and rebates, or drug shortages. Shortages have been especially disruptive lately; if you’re told a product is “not available,” it’s worth checking the FDA’s shortage page to confirm and to understand the expected duration. If it’s a safety withdrawal, an appeal likely won’t help—but your clinician can help you switch safely.

  • If a generic launched, the plan may remove or re-tier the brand. Ask about a tiering exception if the brand is medically necessary (e.g., adverse reaction or therapeutic failure on the generic).
  • If a prior authorization or step therapy appeared, your prescriber can submit clinical documentation to meet criteria or request an exception to those rules.
  • If it’s a Part D mid-year change, plans must give advance notice or a temporary supply in specific situations (details below). That buys time for an exception request.

Quick actions that protect your access and budget

When the price shock hits, I try to stabilize the next 30–60 days first:

  • Ask for a temporary or “transition” fill. Medicare Part D plans have formal transition policies that can provide a short-term supply when a drug becomes non-formulary or newly restricted, especially at the start of a plan year or when you’re new to a plan. That window is designed to avoid abrupt interruptions while you and your clinician pursue an exception.
  • Call the plan the same day. Request the coverage criteria for your drug and the exceptions/appeals forms. Ask whether an expedited review is available if delay could harm your health.
  • Loop in your prescriber early. Appeals move faster when the prescriber sends a brief, targeted letter addressing the plan’s criteria directly (failed alternatives, adverse effects, clinical rationale).
  • Discuss cost-savvy alternatives. Sometimes a therapeutically similar option in a lower tier is perfectly appropriate; other times it isn’t. I’ve learned to ask my clinician to suggest two backup options—one “good enough” and one “ideal if approved.”

How to request an exception that actually lands

I used to think exceptions were essays. They’re not; they’re checklists. Plans—especially Medicare Part D—publish criteria. Your prescriber’s note should mirror those bullets:

  • Diagnosis and context: What condition is being treated, how long, and what’s been tried.
  • Treatment history: Document failures, partial responses, or adverse effects with specific dates/durations.
  • Why alternatives aren’t suitable: Contraindications, interactions, allergy history, or clinical nuances (e.g., specific release formulation).
  • Requested action: Coverage of a non-formulary drug, removal of step therapy, or a tiering exception.
  • Urgency: A clear statement if waiting for a standard timeline would risk serious harm (to meet expedited criteria).

Appeal pathways without the fog

Instead of memorizing acronyms, I keep this map on my phone:

  • Employer or individual/Marketplace plans: Start with an internal appeal. If denied, ask for an external review by an independent reviewer. On the federal standard process, you generally have 4 months from the final internal denial to request external review; decisions are typically due in ≤45 days (or ≤72 hours if expedited). See the official external review page for details.
  • Medicare Part D (drug plans, including MA-PD): First ask the plan for a coverage determination or an exception. Standard decisions are due in about 72 hours; expedited decisions are typically 24 hours. If denied, file a redetermination (appeal) with the plan; if still denied, an independent reviewer looks next.
  • Medicare Advantage for services/Part B drugs: You can request a plan organization determination and then a reconsideration. Standard pre-service appeals are usually decided in about 30 days, payment appeals in 60 days, and expedited cases in ≤72 hours, with limited extensions when truly necessary.
  • Medicaid: Follow your managed care plan’s appeal route, then request a state fair hearing if needed. Timelines differ by state.

Timelines at a glance I actually remember

  • Marketplace/Employer plans: External review must be requested within about 4 months of the final internal denial; decision in ≤45 days or ≤72 hours if expedited.
  • Medicare Part D exceptions/coverage determinations: Plan decision in 72 hours (standard) or 24 hours (expedited) once the plan has your prescriber’s supporting statement.
  • Medicare Advantage appeals (services): Decision in roughly 30 days (pre-service), 60 days (payment), or ≤72 hours if expedited; extensions are limited and must be justified.

When in doubt, I go back to the denial letter—appeal windows start ticking from specific notices, not from when I first got annoyed at the pharmacy counter.

If you’re in Medicare Part D, know these mid-year rules

The Part D manual spells out how plans can change formularies and what protections you have. Two points I keep bookmarked:

  • Advance notice or temporary supply: Before a negative mid-year change takes effect, Part D plans must either send you written notice at least 60 days in advance or give you a 60-day supply at refill time with written notice of the change. That heads-up is your window to request an exception.
  • Transition fills and continuity: New plan year? New to a plan? Just hit with a new restriction? Transition policies are meant to prevent abrupt therapy interruptions while you and your clinician switch or appeal.

I’ve seen people lose weeks simply because they didn’t know that a 60-day buffer existed to set up an exception. I didn’t know that once, either.

Paperwork that quietly wins appeals

Here’s what I keep in a single folder (digital or paper):

  • Medication list with dose, frequency, prescriber, and start dates.
  • Treatment history (a brief timeline of what I’ve tried and why it didn’t work).
  • Denial/EOB letters and plan criteria printouts for the drug.
  • Clinician’s support letter drafted against the plan’s bullets, not in prose.
  • Call log with dates, names, and case/reference numbers.

What to do about costs while an appeal is pending

My rule is to stabilize the short term and prevent gaps in care:

  • Ask the plan about bridge options (transition supplies in Part D, short overrides, or sample packs if clinically appropriate).
  • Ask your clinician whether a therapeutically appropriate alternative exists in a lower tier while the appeal runs.
  • Ask the pharmacy if the dispense as written (DAW) or NDC choice affects coverage (sometimes a different manufacturer NDC processes differently).
  • If you pay out of pocket during an appeal and later win, keep itemized receipts; plans may reprocess the claim and reimburse according to plan rules.

Signals that tell me to slow down and double-check

  • Safety issue or recall: If coverage changes due to a safety warning or withdrawal, appeals won’t reinstate it. Switch safely with your clinician.
  • Shortage-driven switch: If a true shortage exists, coverage may shift temporarily. Check the FDA’s shortage page and ask about equivalent formulations or strengths.
  • Timeline confusion: If you don’t know when the appeal clock started, reread the denial letter—those dates matter more than any verbal promises.

Helpful official resources I keep handy

What I’m keeping and what I’m letting go

I used to treat a formulary change like a brick wall. Now I see it as a fork: either prove medical necessity and request an exception, or pivot to a clinically appropriate alternative with eyes open about cost. The principles I bookmark are simple: name the change, know your plan type, and work the timeline. That mindset doesn’t erase the stress, but it does convert it into a to-do list I can finish over lunch instead of spiraling for a week.

FAQ

1) Can my plan change drug coverage in the middle of the year?
Answer: Yes, plans can make changes, but guardrails vary. Medicare Part D has specific notice and transition rules; employer and individual plans also change formularies but must follow your plan documents and appeal rights. Check your EOB and call the plan to confirm the effective date and your options.

2) What’s a “transition fill,” and who gets it?
Answer: In Medicare Part D, a transition fill is a short-term supply when you’re new to a plan or hit a new restriction, meant to prevent sudden therapy gaps while you switch or file an exception. Ask your plan whether you qualify and how many days are allowed.

3) How fast can an appeal be decided?
Answer: It depends. In Marketplace/employer plans, external reviews are generally due within about 45 days (or 72 hours if expedited). Part D coverage determinations and exceptions are commonly 72 hours standard and 24 hours expedited once your prescriber’s statement is received. Medicare Advantage pre-service appeals are often 30 days (72 hours if expedited).

4) If I pay cash while waiting and then win, can I get reimbursed?
Answer: Often, yes. Keep detailed receipts. If your appeal overturns the denial, the plan can typically reprocess the claim under your benefits. Reimbursement amount depends on plan rules (deductible, tier, coinsurance).

5) My doctor wants the brand, but the plan pushes the generic. Can I appeal the tier?
Answer: You can request a tiering exception or non-formulary exception when medically justified (e.g., documented intolerance or failure on the generic). It isn’t guaranteed, but a targeted prescriber letter aligned to the plan’s criteria improves your odds.

Sources & References

This blog is a personal journal and for general information only. It is not a substitute for professional medical advice, diagnosis, or treatment, and it does not create a doctor–patient relationship. Always seek the advice of a licensed clinician for questions about your health. If you may be experiencing an emergency, call your local emergency number immediately (e.g., 911 [US], 119).