Dr Debra Patt on Prior Authorization: Something Has to Give

Debra Patt, MD, PhD, MBA, MPH, executive vice president of Texas Oncology, medical director for public policy for The US Oncology Network, and new president of the Community Oncology Alliance, highlights the growing burden of prior authorization on oncology practices, describing it as an "inappropriate barrier" that delays patient care and increases administrative costs.

In this interview, Patt also calls for a legislative fix to address the CMS interpretation of the Stark Law, which currently prohibits mailing oral cancer medications to patients, disproportionately affecting those in rural areas. With bipartisan and bicameral support for reform, she remains optimistic that these issues will receive greater attention in the current legislative session.

This transcript has been lightly edited; captions were auto-generated.

Transcript

You've been very outspoken on the issue of prior authorization. Has prior authorization reached a tipping point where something has to give?

Utilization management, or how insurance companies manage utilization, is important and complicated. But I do think that there are ebbs and flows to this, and it has definitely swayed so much that it is, right now, an inappropriate barrier and hurdle to patient care.

We need the pendulum to swing in the other direction, because it's too prohibitive for patients to get the care that they need. This means that even though my reimbursement has declined, I have to employ people in my office just to manage the prior authorization; I have to write separate letters. Just last week, I was writing [a letter] for a pill for a patient with a high-risk breast cancer, and it's clearly FDA approved, she clearly meets all of the inclusion criteria, this is on NCCN [National Comprehensive Cancer Network] guidelines. And I got pushback from the insurance and initial denial, and they need a letter of medical necessity.

So, I wrote the letter of medical necessity, and my nurse spent several hours managing the appeal, and probably it will ultimately get approved. But the barrier of them doing an initial denial will cause some people to not get that therapy, and it's inappropriate for us to spend additional time and effort on doing that, because that's time and effort that I'm not spending with other patients that need my service.

Let’s talk about the Stark Law. Since this problem arose due to an interpretation of the statute under the Biden CMS administrator, with the change of administration, is there a possibility of a regulatory fix?

During the COVID pandemic, and even before that, we were all giving mail order pills to patients. These pills frequently are oral oncolytics; they represent about a third of the cancer therapies that we give today, so it’s a large portion.

When patients could not come to the office and pick them up, we were able to mail order them to patients, these pills that they take control their cancer. And that's really helpful because, again, I practice in the great state of Texas, and we see a lot of rural Texans in our cancer centers, and for them to not have to come back to pick up a medication, it's really useful. And if they're at home, then they can't send someone else to do it, because after May [2023], CMS put out an FAQ that said it’s a Stark Law violation to mail patients oral oncolytics to them at their home. And so, our ability to do that has gone away.

We had a lot of success in passing legislation last session. Rep Diana Harshbarger’s (R, Tennessee) bill, HR 5526, was passed in the House and then went over to the Senate, and there was some discussion about including it in the continuing resolution. Ultimately, there just wasn't enough time to get it across the finish line.

I think that there is bipartisan and bicameral support for the legislation, so I think it's going to need to be reintroduced. It's really important, particularly for rural Americans who require pills to treat their cancer.

There seems to be a lot of interest in the concerns of rural medicine generally, and now we have a Senate Finance Chairman from Idaho. Are you optimistic that these concerns are going to receive a little more attention than they have in the past?

I am optimistic. I think health care is complicated, it’s important that people have perspectives. I think that perspective is going to be incredibly useful, especially for this issue.