Patients Left to Cost-Sharing for Therapies Without Federal Government Intervention

Carl Schmid, executive director, HIV+Hepatitis Policy Institute

Image credit: HIV+Hepatitis Policy Institute

For patients who have chronic conditions and rely on medicines on a daily basis, the rise in prescription pricing continues, and people are being asked to share more of the costs. In the 2026 Notice of Benefit and Payment Parameters rule proposed last fall, the Biden administration failed to include new regulations on whether copay assistance will count as part of patient cost-sharing.

This means insurers can continue to keep drug manufacturer copay assistance without applying it to a patient's deductible or out-of-pocket maximum—leaving patients responsible for up to thousands of dollars in costs.

While the former Biden Administration deserved credit for lowering the cost of insulin, which was a significant achievement, it took a different approach when it came to cost-sharing for therapies.

The patient advocacy organization, the HIV+Hepatitis Policy Institute, asked the Biden-Harris administration to comply with the US District Court ruling that struck down the rule that allows insurers not to count copay assistance towards a patient’s out-of-pocket costs. In extensive comments submitted on the 2026 Notice of Benefit and Payment Parameters Proposed Rule (Proposed NBPP Rule), the patient organization, which was the lead plaintiff in the successful litigation against the US Department of Health and Human Services, argued that not only must the federal agencies comply from a legal standpoint, but that it is the right thing to do for the American people as they struggle to afford their prescription drugs.¹

“They have been disregarding the law for over a year, haven’t issued a promised new rule, and time is running out,” Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said in a statement last fall. “They need to stop siding with the powerful insurers and their PBMs, and instead side with patients.”

This remains in limbo without any timetable in sight.

Contagion spoke to Schmid about the ongoing issue.

Contagion: What were the main criticisms directed at the former Biden administration regarding the 2026 notice of benefit and payment parameters proposal?
Schmid: So the actual proposal was fine; it keeps the market stable. But what the problem has to do with is copay assistance and making sure it counts for patients.

The insurance companies fought us in court. We won, and they said we're going to issue a new rule. Well, that was over a year ago. We thought it would be included, as well as define what cost sharing is and if copay assistance must count in terms of cost sharing. They could go the other way too and say that copay assistance can't count. So they punted. They just said in the proposed rule that we're going to issue a further rule regarding our case and the definition of cost sharing regarding patient manufacturer assistance to patients.

We're asking them to comply with the court order, and said that the 2020 rule is now in effect—that cost sharing must count for brand name drugs, except if there's a generic alternative.

Contagion: You mentioned the federal courts 2022 decision on copay assistance, why is the government not enforce the court's ruling?
Schmid: I guess they're getting pressure from the big insurers and the big PBMs. And you know, what I'm hearing is that the insurers are saying this leads to higher drug prices. And you know, the Biden administration has really prided itself on taking on Big Pharma and lowering drug prices. Well, this is the perfect example to lower drug prices. And I don't think they understand it.

Contagion: What is the significance of the Essential Health Benefits (EHP) loophole, and how are employers and insurers exploiting it to the detriment of patients?
Schmid: The Affordable Care Act requires insurers to cover 10 essential health benefits, and prescription drugs is 1 of them. Some vendors, insurers, employers, and PBMs are working together. What they're doing is saying, 'oh, we're going to cover this drug, but we're going to say it's not an essential health benefit.'

And that means you don't have to apply the cost sharing limits. The drugs that they select as nonessential health benefits are the drugs that have copay assistance from the drug manufacturers. So what they're doing is they're collecting all that copay assistance for themselves and not for the patient. And so the patient is able to pick up their drug, but you have to sign up for these alternative health programs. They're just exploiting a loophole, collecting a lot of copay assistance.

This is how they do copay maximizers, and it doesn't apply to the patient's deductible. They said that they would do this; that they would say that a covered drug has to count towards essential health benefits. And again, this is another rule that they haven't issued.

Contagion: Why is there a delay in implementing new regulations on copay assistance and EHP coverage?
Schmid: Copay assistance last year was $23 billion. And if the manufacturers didn't offer that, patients would have to come up with that themselves. That's a lot of money. People are already complaining about the high cost of drugs, and the high cost to live these days. And when you have copay accumulators and maximizers, the copay assistance does not count towards a patient's out-of-pocket cost and deductible.

One of the beauties of the Affordable Care Act is that there's an annual out-of-pocket limit—after you pay your monthly premiums—which are also going up. But that limit for 2026 is going up 10% from 2025. It's going to be $10,150 for an individual, and $20,300 for a family. The copay assistance can really help, but people are stuck possibly paying over $20,000 in out of pocket costs, even though they're getting copay assistance too. This is a real boon to the insurers.

Contagion: It's important to consider patients who have chronic diseases and who are on regular medicines and therapies. What does this really mean for people that rely on medicine on a regular basis?
Schmid: They may have trouble affording that medication, especially expensive specialty drugs where they may have to pay a coinsurance based on the list price of the drug. You may be paying thousands of dollars up front in January or February and or when the copay assistance runs out by the manufacturer, which may be May or June. A person or a family may not pick up their drug, and it may impact their health.

The conversation was edited for grammar and clarity.

Reference
1.Biden-Harris administration urged to comply with court decision & require insurers to count copay assistance.HIV+Hepatitis Policy Institute. November 13, 2024. Accessed January 23, 2025.
https://hivhep.org/press-releases/biden-harris-administration-urged-to-comply-with-court-decision-require-insurers-to-count-copay-assistance/