USPSTF Guidelines for HIV PrEP: Using Medical Management Techniques

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Ryan Haumschild, Doctor of Pharmacy, MS, MBA: Another question that arises is when can a planner or issuer use reasonable medical management techniques? It’s jargon that needs to be peeled. I’m going to speak to our resident expert, Sean. We are reviewing these guidelines, and when you hear this, what does it mean for our health plans? What was the intended direction of this statement?

Sean E. Bland, JD:The essence of management techniques is that they might encourage patients to use certain services or medications over others. Plans and insurers may use medical management techniques when guidelines do not specify frequency, method, treatment, or setting of surface delivery. What this means for PrEP delivery [pre-exposure prophylaxis] medicine is that reasonable medical management is allowed to give preference to specific medicines, such as those without cost sharing and imposing cost sharing for other products. For example, plans can cover a generic version of PrEP without cost sharing and apply cost sharing to an equivalent brand version. However, plans are needed to accommodate anyone for whom a particular generic or brand name PrEP drug would be medically inappropriate. It is medically inappropriate as determined by the individual’s healthcare provider. This requires that plans have a mechanism to waive otherwise applicable cost sharing. If plans use these types of techniques to limit access to specific PrEP products or services, they should also have an exception process that is easily accessible, transparent, and sufficiently expeditious. In addition, this process should not be unduly burdensome for individuals or their suppliers. I hope this gives some context of what is meant by medical management techniques and what they should be. It must be a reasonable approach that allows access.

Ryan Haumschild, Doctor of Pharmacy, MS, MBA: It’s interesting because the transparency, making it easily accessible, having a good exceptions process – sometimes when you unzip our payer policies, it can be a little trickier in the eyes of the viewer. How they perform matters. Ryan, what are the usage management policies you have regarding PrEP? Do they meet these requirements? Have you heard any comments? Is this a work in progress? Especially when we talk about a fast, transparent and easy process.

Ryan Bitton, PharmD, MBA: Good question. Each of these words – accelerated, transparent, easy – has many definitions. In your opinion, what might be easy for me to live in the payer space for 15 years may not be easy for other people. In my organization, in many organizations, there is a preference for certain cheaper drugs. There are SEO strategies around this drug. I worked with local vendors in my community to share a transparent format. Here are the criteria we use. You don’t have to guess when that patient is an exception and they need the most expensive product, and they have to go through that process. There was always some confusion. We need to be transparent and say, “Here’s the policy,” publish those policies, and post them. It’s not a guessing game when you submit for this exception. It is important. It helps to be transparent.

The outreach I have with 1 provider in my community has been helpful. He was getting frustrated. There’s a lot of frustration because there’s not a lot of consistency. Although we have consistent policies, you have different numbers to call, different forms to use. There is some complexity. Unfortunately, it’s the health care system, and we have to deal with that. Once people know about the process, it’s easy and it can be seamless. As it concerns accelerated okay, is it 24 hours or 72? It depends on the line of business, but for many payer policies, once you say accelerated, that’s 72 hours or less. In the world of Medicaid, we talk about 24 hours. For a lot of people, it’s easier to say, “This is one of those accelerated things that we’re going to throw in the bucket to get it done as fast as we can.” We will probably do it in less than 72 hours. Many organizations are similar. We have 24-hour processes, so let’s throw those things into those 24-hour processes.

Ryan Haumschild, Doctor of Pharmacy, MS, MBA: Thank you for giving us a little background on these terms, as they can be interpreted differently. The one that keeps coming back is medical necessity. We treat it in many therapeutic areas. It’s not new, but when you think of these FAQs [frequently asked questions], how are you and payers adjusting to medical necessity? Do you use pre-authorizations to meet this requirement? Is there a refusal or appeal process? In this PrEP process for some of these therapies, what are some of these criteria that you use to classify something as a medical necessity? What is this route to work through a medical necessity appeal or prior authorization?

Ryan Bitton, PharmD, MBA: There are many there. Let me wrap this up. With members and suppliers, there is always an exception process or an appeal process. It’s still there. It can be time consuming and complicated, but there is a process. There’s always a way to do that. What does mean medical necessity mean? It’s hard to define. It’s probably easy to define, but there are different definitions. My interpretation is that there are probably 2 levels. A, medically necessary means we have supported the data, FDA indication, guideline recommendations. There must be medical support for the use of the product in general. As payers, we sometimes prefer Product A over Product B. But there are times when Product A is not appropriate. In these cases, it becomes medically necessary for the patient to use Product B. Most managed care colleagues can identify specific examples of exceptions when Product B should be used. We include them in our criteria and we approve the $0 co-payment in these situations. Of course, there are situations that cannot fall under a medical policy. This is where each individual review through the exception process will also determine medical necessity.

Ryan Haumschild, Doctor of Pharmacy, MS, MBA: You used some of the terminology as time consuming and complex. I remember once speaking with a payer who said, “Time well spent. It’s interesting to see the different perspectives of a provider and payer as we work through these medical necessities because you can see it as an appropriate step to managing the benefit. The provider may feel that this is wasted time that could have been spent on patients. It’s interesting to see the different approaches.

Transcript edited for clarity

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