Q&A: Amy Niles on Patient Access Reform in 2026

Patient access in 2026 is pulling in two directions at once. Prior authorization is getting faster under new CMS rules, but coverage itself is contracting as Medicaid work requirements take hold and exchange premiums climb.

To unpack this, Pharmaceutical Commerce spoke with Amy Niles, chief mission delivery officer at the Patient Advocate Foundation, about prior authorization reform, the Medicare Prescription Payment Plan, Medicaid work requirements and what her organization is watching most closely as the year plays out.

Has prior authorization reform or the Medicare Prescription Payment Plan delivered for patients this year?

When it comes to prior authorization, there have been some changes and improvements since the beginning of the year which are good for patients. It's trending in the right direction. We need more change but let me describe some of the key elements that I think will be helpful, not only to patients, but also to providers.

CMS finalized a rule back in January relating to prior authorization for non-drug items and some services, like some procedures and durable medical equipment, for example. So a few key items. One is that the final rule made decisions around prior authorization shorter. That's good news. Prior to this rule, payers could take up to 14 days to make decisions. Now, standard prior authorization requests must be acted upon within seven calendar days, and more urgent requests must be decided within 72 hours. That's positive for patients because patients are waiting way too long for decisions to be made about their services and procedures.

Secondly, when denials are issued, there must be a clear reason for those denials, and that's important, especially when the patient working with the healthcare provider may want to appeal. They'll have more decisions to base that appeal on.

Thirdly, payers are now required to publicly report metrics around prior authorizations, so their approval rates, their denial rates and appeals outcomes. And I think that just adds greater transparency and accountability to the healthcare system.

Looking ahead, by January 1st of 2027, there's electronic prior requirements – prior authorization API requirements that will be in place. That is really important, because from the provider perspective, they're spending an awful lot of time right now on the phone waiting for people to talk to about prior authorization. This should speed up the process even more. So, that final rule on January 1st was very, very important.

Secondly, there's a pilot program that has gone into effect by CMS. Its acronym is WISeR, and it's known as the Wasteful and Inappropriate Service Reduction Model. It requires prior authorization in traditional Medicare in only six states – Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington – and what these programs will be doing is applying AI, along with a human to review clinical information to make prior authorization decisions. That went into effect January 1st, 2026. It's a five-year program. I think we'll learn from that pilot.

And then finally, CMS issued another proposed rule in April. We're awaiting a final rule, and if issued, these changes would be implemented October 1st, 2027. This proposed rule is for new drug prior authorizations, so it would support electronic prior authorization for drugs covered under the medical benefit, including therapies in the Part B program, and it would also shorten the process. I think all of these are good steps.

We still have a piece of legislation that is pending. It's the Improving Seniors Timely Access to Care Act. It would reform prior authorization in Medicare Advantage programs. It has tremendous bipartisan support, but it has not reached committee or the floor. And I think this piece of legislation remains really important, because it would help codify some of the changes that we've seen on the CMS side.

On the Medicare Prescription Payment Plan – I continue to say it was a significant reform that went into effect as part of the Inflation Reduction Act. It helps people spread their out-of-pocket costs throughout the calendar year. It is not for everybody, but for those who, for example, have very high costs, it can help make them more affordable. Interestingly, the PAN Foundation, just prior to our merger with the Patient Advocate Foundation, commissioned some research with IQVIA, and we looked at five therapeutic areas. Not all therapeutic areas, but five high-cost areas including prostate cancer, breast cancer, multiple sclerosis, rheumatoid arthritis, and pulmonary arterial hypertension. One of the areas that we were really interested in was the uptake of the Medicare Prescription Payment Plan in 2025, now that one year had been operationalized. What we found, which is similar to what CMS is finding and others, is really low uptake. Only 7% of people who could opt in actually opted in.

Of the people who opted in, they showed a much lower rate of patient therapy abandonment than those who didn't opt in. For Medicare beneficiaries who were not using the Medicare Prescription Payment Plan, they had a 41% chance of abandoning their therapy, and that rate lowered to 17% for those using it. So, it remains a very significant reform.

Similar to this research, we did our own research surveying Medicare beneficiaries, both at the PAN Foundation and the Patient Advocate Foundation. Again, this was just prior to our merger. We polled more than 4,200 Medicare beneficiaries. Only half of them had heard of the Medicare Prescription Payment Plan. So, we still have a whole lot of education to do around the Medicare Prescription Payment Plan, and again, we know it's not for everybody, but there's a good number of people who are likely not opted in who could benefit from just being able to make their costs more affordable throughout the year.

How are Medicaid work requirements and ACA premium tax credit expirations affecting access and affordability in 2026?

I don't think it's playing out well at all, to be honest. Let's look at Medicaid first. According to the Kaiser Family Foundation, we have about 18.5 million people who are enrolled in Medicaid now who are going to have to prove their work requirements that were put into law, with the One Big Beautiful Bill. Now, they might be able to attest to their inability to work in 2027, but that's going to change in 2028.

The rules seem a lot more restrictive than they were originally conveyed. People are going to need to provide documentation about their work requirements or their volunteer commitments, and they're going to be needing a statement from their healthcare provider, their medical provider, that their health condition prevents them from working. And on top of that, each state is going to have their own guidelines in terms of the severity of the medical conditions.

As a result of all this, unfortunately, we anticipate millions of people ending up without Medicaid coverage, one, because they may not meet the work requirements, and two, there's just a whole lot of administrative burden and paperwork. People might just be inclined to say, “forget it. I'm not going to do that.” And as a result, millions will go without coverage. It's going to tax the healthcare system significantly moving forward.

As we look at the exchanges, I'm not terribly optimistic here either. I think we'll continue to see double-digit increases in healthcare insurance premiums. These are already taxing millions of individuals, and we know that as of February 2026, 3 million people had dropped out of the exchanges. So, I think all of this does not bode well in terms of patient affordability for care, including prescription medications.

Is affordability and access in 2026 better or worse than you expected?

It is definitely not better, and I think it is trending towards worse.

When we did the poll of Medicare beneficiaries, and I know that's a subset of the overall population but it's an important subset, of the 4,200 people that we polled, 83% told us that they're on fixed incomes, which means they're challenged affording not only medical care, but the everyday expenses. And they're on a fixed income, and six out of 10 said, “You know, my income is not rising. It's remaining fixed.” Most of the individuals reported seeing increases over the last 12 months in premiums, in their healthcare provider costs, in their pharmacy costs as well, and four out of 10 told us, “You know, if these costs continue to rise, I simply can't absorb any more increase in cost.”

What's happening, it continues to reflect what we've seen over many years. One out of three, when it comes to pharmacy costs, they're not filling prescriptions, or they're delaying. And they're making decisions about what they can afford. They either have to decrease their non-medical costs to be able to afford their medical costs, or they're making unfortunate decisions.

So, I think certainly as we look at the Medicaid population, we're going to see enormous challenges, over the next couple of years. These individuals are either going to continue to face these challenges, or they're going to decide, “I'm going to go without coverage because I'm not going to be able to meet these requirements.”

Where do you see patient access heading in the back half of 2026? What key trends and policies are you monitoring?

Let's start with the Medicare population. We have seen that there has been, in the Part D program, a Medicare Part D cap, which has been helpful for many beneficiaries. This year it's $2,100. Well, next year in 2027, it's rising to $2,400. So yes, I always used to say, and I continue to say, $2,000, 2,100, $2,400 is certainly better than what Medicare beneficiaries were forced to pay years ago, but it's trending in the wrong direction, and it is still unaffordable for many individuals. Also, recognizing that the pharmacy piece of it is just a piece of their total cost of care.

Medicaid, we are watching very, very closely. We encourage patients, patient groups and provider groups to get involved in policy and advocacy because sharing stories and making sure we continue to advocate for patient-centric policy solutions is really important.

We are very concerned about the rising premiums and the limited or reduced opportunities there will be for people on the exchanges. All of this is going to continue to tax the healthcare system. We're going to see more visits to the emergency room. We're going to see more hospitals close, especially in rural communities where access has been a challenge for many, for many years.