One of the key consumer protections in the Affordable Care Act is the requirement that plans must have a limit on out-of-pocket costs. In 2014, plans must limit out-of-pocket costs to no more than $6,350 for individuals and $12,700 for a family plan. However, there are limits on the limit, and the details matter. For one, this protection does not apply to grandfathered plans. In addition, plans do not have to count consumer spending on out-of-network care, non-essential health benefits, or non-covered services. And in 2014, employer-sponsored plans with separate out-of-pocket limits for certain benefits (for example, one for medical benefits and another for prescription drugs) have considerable flexibility in how they set their limits.

As part of our Robert Wood Johnson Foundation-funded Navigator Technical Assistance project, we received a question that falls under one of those limits on the limit. A Navigator from Georgia asked: If a patient purchases a plan through the Federal Marketplace that does not cover a specialty tier drug that the patient needs for a chronic condition, does that mean the patient is responsible for the full cost of that prescription drug, and the out-of-pocket cost will not be included as part of the patient’s out-of-pocket maximum for the marketplace plan?

Unfortunately, the simple answer is “yes” and “yes.” Plans are not required to count patient costs for a non-covered drug toward the out-of-pocket limit, which for specialty drugs can be substantial and even cost-prohibitive. However, consumers in this difficult spot have options. Under federal rules, plans that provide Essential Health Benefits must have procedures in place that allow an enrollee to “request and gain access to clinically appropriate drugs not covered by the health plan.”

Most health plans have an exceptions process for requesting coverage for non-formulary drugs. In addition, states may have requirements for what those processes must include to meet state licensing standards. In the Federal Marketplace, health plans must have an exceptions process that meets federal standards. This exceptions process is separate from the ACA-required process for appealing a benefit denial.

The federal standards note that plans can use their existing exceptions processes, as long as they allow a consumer to request both an internal review by the plan and an independent review of the exception request. If it doesn’t allow for both, CMS “encourages” health plans to use a CMS-outlined process that includes both an internal review and an independent review, with detailed timeframes for quick turnaround of a response to the request, particularly where a consumer’s health condition requires a timely answer.

Federal rules also suggest plans follow Medicare Part D guidelines for determining whether a drug is clinically appropriate. Under those guidelines, a drug is clinically appropriate and should be covered if the consumer’s prescribing physician has determined that the alternatives available to the consumer – other covered drugs, the same drug in a different dose, or an alternative drug that must be tried first – would be ineffective, cause harm, or affect patient compliance with the prescription treatment.

And finally, CMS strongly encourages plans to allow the consumer to have access to the medication in dispute as the exceptions process is underway, and, if coverage is granted, to continue to allow the consumer access to the drug in future plan years if they remain enrolled.

Of course having an exceptions process does not ensure patients will ultimately gain access to non-formulary drugs. But having such a process makes access at least possible, with the potential added benefit of lower costs and inclusion in the out-of-pocket limit.