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In today’s AMA Update, how a physician's quest to ensure patient access to PrEP—a key medication in preventing HIV infection in high-risk patients—has gained national traction with help from the AMA Integrated Physician Practice Section (IPPS).
Stephen Parodi, MD, executive vice president of external affairs, communications and brand at The Permanente Federation, and associate executive director for The Permanente Medical Group in Oakland, California, discusses how the AMA House of Delegates (HOD) and IPPS supported action regarding insurance coverage for Pre-
Learn more on the AMA's amicus brief filing and involvement in Braidwood Management v. Becerra case.
- Stephen Parodi, MD, executive vice president of external affairs, communications and brand,The Permanente Federation; associate executive director, The Permanente Medical Group
Unger: Hello, and welcome to the AMA Update video and podcast. Today, we're talking about how one physician leader and the AMA's Integrated Physician Practice section are fighting to maintain access to PrEP—a key medication in preventing HIV infection in high-risk patients.
I'm joined today by Dr. Stephen Parodi, executive vice president of external affairs, communications and brand at the Permanente Federation and associate executive director for Permanente Medical Group in Oakland, California. I'm Todd Unger, AMA's chief experience officer in Chicago. Welcome back, Dr. Parodi.
Dr. Parodi: It's very good to be with you, Todd, today.
Unger: Well, for physicians out there who may not be aware, why don't we just start by giving a little bit of background on the medication known as PrEP and its role in decreasing new HIV infections. Talk to us a little bit about the science behind this and why it's so revolutionary.
Dr. Parodi: Sure, pre-exposure prophylaxis, which is basically a preventative medication for HIV infection has been around for a while. The first randomized controlled trial was actually published in 2010, believe it or not. And the U.S. Preventive Services Task Force actually looked at all of the evidence in 2019 and there are now 14 randomized control trials that show that PrEP is extremely effective at preventing HIV infection if taken appropriately.
So for sexual encounters, it reduces the risk of HIV infection by 99%. And for injection drug use, by 74%. So it's been incorporated into my practice—as an infectious disease physician, we actually have a pharmacist that helps manage the patients, making sure that they get the access to the medication, the education around the medication. But equally important, Todd, it's the lifestyle counseling that goes with this.
So we're not just talking about HIV prevention. We're talking about all sexually transmitted infections and lifestyle modifications, as well as safe sex. And when you put that all together, it's a tremendous combination to be able to prevent HIV infection altogether.
Unger: Well, when you look at that kind of research, that kind of data and that combination that you were talking about very, very persuasive. But now there's a bit of a wrinkle because there's a legal case involving insurance coverage for PrEP under the Affordable Care Act. Talk to us about what the issue is here in this case?
Dr. Parodi: That's right. So there's a case, that's called Braidwood versus Becerra. And there were actually two relatively obscure legal doctrines that were used raising questions around the appropriateness of insurance coverage for PrEP. So the first was looking at the Religious Freedom Act. And actually, a suit was brought relative to a particular employer saying that having to provide PrEP actually violated their religious doctrines around prevention of HIV infection. And more importantly, potential behaviors that are leading to HIV infections, such as homosexual behavior.
And the court actually ruled that in fact, the U.S. Preventive Services Task Force recommendation violated the Religious Freedom Act. That an employer can't be required to provide the service. The second thing, which is even more obscure, was that the court ruled that this violated the Constitution's Appointments Clause. So it turns out the U.S. Preventive Services Task Force is actually appointed by the Secretary of Health and Human Services.
They're not subject to appointment by the President and confirmation by the Senate. And because the Affordable Care Act actually requires insurance coverage for any U.S. Preventive Services Task Force recommendation of Level A and B, which in this case, PrEP is a Level A recommendation, the secretary has no authority to actually countermand the U.S. Preventive Services Task Force. And so they said that actually that's not appropriate. The secretary actually has to be able to have ultimate decision making authority.
And because of that violation, not only is PrEP thrown into question, but the court ruling was that all U.S. Preventive Services Task Force recommendations are now at risk.
Unger: Wow, that is a huge challenge. And you talked a little bit about your infectious disease practice. Obviously, something like this would have huge implications for you, correct?
Dr. Parodi: Absolutely. So when I think about it for my own clinical practice, I worry about patients not having access. The particular medication that's used for PrEP is expensive and most people can't afford it without insurance coverage.
So undoubtedly, we know even as of this current date, on an annual basis, there are 34,000 new infections with HIV every year in the U.S. That would undoubtedly go up. And we already know that only about a quarter of people that are actually eligible for PrEP take it now.
So if that number were to go down, I worry about how many people I would be having to take care of not from a preventative standpoint, but actually infection standpoint. Now, the second bigger picture question that really worried me is that this is not just about PrEP. We're talking about access to vaccines, access to other critical services.
Think about cervical cancer screening. You know, other things that are required right now under the ACA are now thrown into doubt.
Unger: So, you've been involved with the AMA for some time now. I'm curious faced with a challenge like that, did the idea come to mind, hey, I can use the AMA policy process to help resolve something like this, or at least fight that?
Dr. Parodi: Yeah, it's a great question, Todd. So to be honest with you, first, I had to get over my anger over the ruling. And then I said, OK, what can we do and can we take action? And actually, can we take action collectively as the House of Medicine?
And so we've—the Permante Medical Group—has become a part of the AMA. I've actually been a member of the AMA for more than 20 years and thought that would be a good venue. And so I talked to some of my colleagues within the Integrated Physician Practice section. They were also supportive of the idea of putting together a resolution, number one, to raise awareness within the House of Delegates about this matter and hopefully a willingness to take collective action to support PrEP as an essential health benefit under the ACA.
And also, secondly, to raise awareness, because I'm not a lawyer, with the legal staff at the AMA to see if we could garner their help and support for potentially filing a brief with the Court of Appeals regarding this decision.
Unger: Well, it's got to be pretty gratifying, then, to see that resolution was adopted by the House of Delegates at the November Interim Meeting. And subsequently, the AMA has since filed an amicus brief in this case. What's your understanding of the impact of your resolution on that filing?
Dr. Parodi: So, one thing I want to first comment on is it was so gratifying to be a part of the House of Delegates and to get the input from my fellow colleagues. So there was a lot of general support and also some recommendations for how to better improve the resolution that was finally passed. So that, I thought, was a great process for being able to exchange with, again, physicians with different modes of practice across the entire country, and to be able to discuss this substantive issue is really critical.
As far as the amicus brief, my understanding is that this is winding its way through the court system and the appellate system. I think—I can't imagine how the AMA and the House of Medicine's voice won't have an impact in particular on this really critical issue where we're talking about the fate of preventative services for all of the patients that we care for.
Unger: Now, for physicians who are out there and who might not be so familiar with the AMA policy process, what's your advice to them on how to advocate for issues like this that really affect their practices and their patients to address those through policy?
Dr. Parodi: You know, Todd, I would say get involved. And number one, pick up the phone, call your fellow physicians. If you know someone who's a part of the AMA, who's part of the House of Delegates, don't be afraid, don't be shy. There are so many people that are willing to help you. And it's not just your fellow physicians. The AMA staff, I have to just say, were extremely helpful for me.
I'm a neophyte when it comes to putting together and writing a resolution. And there were a lot of people that were willing to lend a helping hand about what's going to be effective, what will resonate with my fellow physicians and colleagues, and also how to work with the legal staff. I think there's just a lot of help out there.
But my main message to everybody here is definitely get involved. This example here of PrEP and the court ruling is just one of, I think, many things to come. Health care is at the forefront when it comes to policy makers, when it comes to now our court system. And it's really critical and important that physicians are actually involved with these processes. And I think the AMA is an excellent mechanism to make that happen.
Unger: Well, it's a great story. And you're exactly right, what a terrific example of acting with a unified voice and the power of the House of Delegates to make really important changes that are going to have a big impact on patients. Dr. Parodi, thanks so much for being here today and for all that you're doing with Permanente on behalf of physicians and patients. It's such a pleasure to talk with you, as always.
We'll be back soon with another AMA Update. You can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this podcast are those of the participants and/or do not necessarily reflect the views and policies of the AMA.