Prescription Drug Plan Design

Copay Accumulators and Maximizers in Employer Health Plans

These programs change whether manufacturer copay assistance counts toward an employee’s deductible and out-of-pocket maximum. The federal rules are unsettled, and the plan design decision lands on the employer.

Have Your Plan Reviewed

The Basics

How Accumulators and Maximizers Work

Manufacturers offer copay cards that cover part or all of an employee’s cost for certain specialty drugs. Plans differ on whether that help counts toward the employee’s own cost-sharing limits.

Copay Assistance

Drug manufacturers offer coupons or cards that pay some of an employee’s cost share for a brand drug. The money comes from the manufacturer, not the employee or the plan. For the employee, the card reduces the amount due at the pharmacy. How the plan treats that help is the real question, so ask your PBM how it handles manufacturer assistance under the plan. For a quick estimate, use our free out-of-pocket exposure calculator.

Accumulator Programs

The plan does not count manufacturer assistance toward the deductible or out-of-pocket maximum. The card may run out mid-year and the employee then faces the full deductible. The employee can be surprised when the card runs out and the deductible starts over. Employers should ask how the program is explained to employees and how claims will appear in their cost-sharing records.

Maximizer Programs

The plan sets the employee’s cost share for certain drugs to match the maximum manufacturer assistance available, spread over the year. Employees often pay little or nothing while the assistance lasts. The employee’s cost is often set low while assistance lasts, but the arrangement depends on the manufacturer program continuing. Ask the PBM how the plan would respond if assistance changes mid-year.

Who Runs Them

Many are administered through the PBM or a separate vendor. Ask which party identifies eligible drugs and how the program is described in the contract. The vendor identifying drugs may not be the same one that handles claims. Ask who sets the drug list, how often it changes and whether the employer can see which employees are affected.

Why Plans Use Them

The stated aim is to avoid paying for a branded drug when a lower-cost alternative exists, and to keep manufacturer money from shielding employees from plan design. Whether a program fits depends on the plan’s design, its drug mix and how employees would react. Employers should ask the PBM to explain the rationale in plain terms, and weigh it against employee impact.

Who Is Affected

A small group of employees on high-cost specialty drugs. The effect on those employees can be large. Even a small group can feel significant out-of-pocket exposure, so employers should consider the employee side as well as plan cost. Ask the PBM for de-identified counts rather than named claims.

The Legal Picture

Where the Federal Rules Stand

The rules have shifted through litigation, and we did not find a new final federal rule when we last reviewed. Treat this as unsettled and confirm the current position with counsel.

The 2021 Rule

The 2021 Notice of Benefit and Payment Parameters let plans and issuers decline to credit manufacturer assistance toward cost sharing, with exceptions for state law. This rule changed how plans were allowed to treat manufacturer assistance, and later court action affected it. Treat it as background, and ask counsel for the current position before relying on it.

The 2023 Court Ruling

In HIV and Hepatitis Policy Institute v. HHS, the D.D.C. vacated that part of the 2021 rule on September 29, 2023, finding it arbitrary and capricious. The decision reshaped what plans could rely on, and the agencies may address the issue again through rulemaking. Employers should confirm the current status with counsel before changing plan design or communications.

The Appeal Was Withdrawn

HHS’s appeal was withdrawn in early 2024. The prior 2020 rule generally applies, which allows accumulators for drugs with a generic equivalent. The legal position can still change through new rulemaking, so confirm whether any has been issued. Employers should ask counsel how it applies to their plan and review it again at each renewal.

Enforcement Position

HHS indicated after the ruling that it would not take enforcement action until it issues new rulemaking. That is a temporary position, not a safe harbor, and it can end when new rules are issued. Employers should plan for change, ask counsel what it means for their plan and avoid treating it as protection.

State Laws

Some states restrict accumulators in fully insured plans. Self-funded ERISA plans are generally outside state insurance law, but confirm with counsel. Whether a state law applies depends on whether the plan is insured or self-funded and on where the plan is based. Ask the carrier or counsel which laws, if any, reach your plan.

HSA Interaction

Accumulators can interact with HDHP and HSA rules on deductible satisfaction. Review with a tax advisor before applying one to an HSA-qualified plan. HSA-qualified plans have specific deductible rules, so a program that changes how cost sharing is counted may raise eligibility questions. A tax adviser can confirm the effect before the plan is changed.

Employer Decisions

What Employers Need to Decide

These programs are plan design choices. They should be made on purpose, documented, and explained to employees.

Do You Want One

Ask your broker and PBM what the program would save after fees, and which drugs and employees it would touch. Savings estimates should be modeled, not assumed. A well-run analysis looks at which drugs are involved, expected employee impact and the fees charged. Ask for the modeling in writing and have counsel review the legal and communication risks.

Plan Document and SPD

The plan document and summary plan description should describe how manufacturer assistance is treated. A silent document invites disputes. If the plan treats manufacturer assistance in a particular way, say so in plain language. Ask counsel to review the wording so it matches how the PBM actually administers the program.

Employee Communication

Employees on affected drugs should hear about the policy before open enrollment, not when a claim denies their card. Use a short, plain explanation with examples of how the card and the deductible work together. Give employees a number to call, and send the notice before open enrollment so they can plan.

Vendor Contract Terms

Check fees, who keeps any savings, and what the vendor reports back. Our PBM guide covers contract questions in more detail. Ask how savings are calculated, whether fees depend on those savings and what reports you will receive. Have counsel review the language, since unclear terms can lead to disputes later.

Stop-Loss Impact

If the plan is self-funded, ask the stop-loss carrier how these programs are treated in claims and renewal underwriting. Ask whether the stop-loss contract recognizes the plan’s treatment of manufacturer assistance and how it could affect claims reimbursement. Raise it before renewal so surprises are avoided.

Review Each Year

Because the legal position may change, put this on your annual review list with the PBM contract and RxDC filing. Add a short checklist: current law, plan wording, PBM terms and employee impact. Updating it at renewal keeps the plan aligned with current rules and helps employees get consistent information.

Common Questions

Copay Accumulator Questions

What is a copay accumulator?

A plan rule that does not count manufacturer copay assistance toward the employee’s deductible or out-of-pocket maximum.

What is a copay maximizer?

A program that sets the employee’s cost share on certain drugs to equal the maximum manufacturer assistance available, spread across the year.

Are accumulators legal under federal law?

The 2021 rule that allowed them was set aside in 2023 and the appeal was withdrawn in 2024. HHS said it would not enforce while it writes new rules. Confirm current status with counsel.

Do state laws matter?

Some states restrict accumulators in fully insured plans. Self-funded ERISA plans are generally outside state insurance law.

Who decides to use one?

The employer, as part of plan design, usually with its PBM or vendor. It should be written into the plan document.

Do they affect HSA eligibility?

They can raise questions about deductible satisfaction in HSA-qualified plans. Check with a tax advisor.

How do employees find out?

Through the SPD and open enrollment materials. We recommend telling affected employees in advance.

Will this lower our costs?

Possibly, for some plans. Model it with your PBM and weigh any savings against employee relations and legal risk.

Let’s Get to Work

Send us your renewal.

We’ll tell you whether it looks competitive, where we see opportunity, and the five questions we’d put to your carrier. No cost, and no obligation to move anything.

What to send

The renewal letter
Your current plan summary
Contribution split by tier
Enrolled counts by tier

Four documents — two more if your group is 50 or more. Nothing else; every extra one is a reason to postpone.

Sources

Laws and rules referenced

45 C.F.R. § 156.130 — Cost-sharing requirements and annual limits on cost sharing.

This page is general information, not legal or tax advice. Rules change and facts matter, so confirm your situation with counsel or a qualified advisor.

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