Quantity limits, tier exceptions and forced switches

Sometimes the plan covers your drug, but with strings: fewer pills per month than you were prescribed, the most expensive tier, or a notice that it will cover a different drug from now on. Each is a different kind of request, and your prescriber’s medical reasons carry each one.

What this means

• Quantity or dose limit. The plan covers only a set number of pills, doses or refills in a period. If your prescriber ordered more, ask for a quantity exception. The prescriber’s letter should state your diagnosis, the dose and why a lower amount does not work for you.
• Tier exception. Plans sort drugs into price tiers. If a drug is in a high tier, you can ask for a lower one. In a Medicare drug plan (Part D), the prescriber’s supporting statement for a tiering exception must say that the preferred drug would not be as effective or would have adverse effects. Plans may exclude specialty-tier drugs from exceptions to non-specialty tiers, and need not move a brand-name drug to a tier that holds only generics.
• Forced switch. The plan stops covering your stable drug, or wants you to move to a different brand, generic or biosimilar (a drug highly similar to a brand biologic). Patient groups call a switch with no medical reason a “nonmedical switch”. Ask for an exception that lets you stay on your drug and give the medical reason.

Medicare drug plans (Part D) follow federal timing for coverage decisions. The plan’s first decision is called a coverage determination. It must answer within 72 hours, or 24 hours if urgent. For formulary and tiering exceptions, that clock is counted from when the plan receives the prescriber’s supporting statement. Ask the plan which clock applies to a quantity limit, step therapy or switch request. If you are in the first 90 days of coverage under a new plan, the plan must give a one-time temporary supply of at least an approved month’s supply of a drug that is not on its formulary, or that needs prior authorization or step therapy. Before a negative formulary change, the plan must generally give affected members at least 30 days’ written notice, or a refill with notice when the member requests one. Check the date on your notice, which controls.

Employer and individual plans. We found no separate federal clock for these exceptions. If a plan had approved a course of treatment and then cuts it short, that is a denial. A non-grandfathered plan must give notice early enough that you can appeal and get a decision before the benefit is reduced or ended, and must continue coverage while the appeal is pending on those terms. An urgent request to extend an approved course of treatment is due within 24 hours if made at least 24 hours before the approval ends. Whether a formulary change counts as an approved course of treatment depends on your plan. Ask in writing.

What to do

1. Find the exact rule on the notice or pharmacy message. Is it a quantity limit, a tier, a switch or a removal from the list? The name of the request depends on it. (You.)
2. Ask the pharmacy for a short supply or a hold. Patient groups advise asking the pharmacy for a hold or partial fill while the exception is decided. Whether the pharmacy can do this varies. (You.)
3. Ask your prescriber to write the exception request. Include the diagnosis, the current dose, how long you have taken it, what happened on lower doses or other drugs, and what the prescriber expects if you change. Use the clinician medical necessity letter as a starting point. (Your prescriber.)
4. Send the request to the plan. For Part D use the Part D exception request letter. For other plans use the plan’s form or the formulary exception appeal letter. (You or your prescriber.)
5. Ask for a fast decision if delay could harm you. Your prescriber states this. (Your prescriber.)
6. Appeal in time. Part D allows 65 calendar days from the date on the notice for a first appeal. Employer and non-grandfathered individual plans must allow at least 180 days after you receive the denial. (You.)

What the plan may say, and what to say back

“The limit is a safety rule.” Ask which rule, and send your prescriber’s explanation of why your dose is needed. Ask for the plan’s written criteria for approving a higher quantity.

“We will cover the generic or preferred version instead.” If your prescriber has a reason this version would not work for you, state it in the request. If not, ask the plan whether it will cover the version in the meantime and what it costs.

The rule

A Part D plan must give at least 30 days’ written notice before a negative formulary change, and in your first 90 days in a plan must provide a one-time temporary supply of at least an approved month. 42 Code of Federal Regulations (CFR) 423.120

Watch for

• Cost sharing stays. An exception changes coverage or tier, but you may still pay the cost sharing for the tier. Ask the plan what you would pay.
• Only for state-regulated plans. Several states have their own rules on step therapy or drug restrictions for insured plans. Self-funded employer plans do not follow them. See Washington for an example of what state pages list.
• Be specific. Details about your dose, your history and what happened on other drugs give the reviewer more to work with than a general statement.
• Do not change your dose or stop a medicine on your own because of a limit. Ask your prescriber.

What next

• Formulary exceptions: when the drug is off the plan’s list.
• Step therapy exceptions: when the plan wants other drugs tried first.
• Keep treatment going during an appeal: your rights for care already approved.
• Medicare drug plan appeals: the full Part D ladder.