Jennifer Matthieu's Federal Legislative Update

Fred Goldstein 00:01
Hello and welcome to the AMCP Podcast Series - Listen Up as we take a deep dive into the challenges, trends and opportunities in managed care pharmacy, follow the show's social hashtag #AMCPListenUp. And to learn more about AMCP Visit amcp.org. I'm your host, Fred Goldstein. On this episode, my guest is Jennifer Mathieu, Senior Vice President, professional and Government Affairs at AMCP. Welcome, Jennifer.

Jennifer Mathieu 00:28
Thank you, Fred.

Fred Goldstein 00:29
So fascinating time Congress is dealing with a whole bunch maybe. So why don't you give us the lay of the land?

Jennifer Mathieu 00:36
Absolutely. My pleasure. So here we are in April of an election year presidential election year. And currently, we are starting to slow down on legislative activity that is not considered urgent or emergency level. Obviously, there's still legislative action happening. But healthcare related legislation is likely going to be later in this year where we can actually make some progress on various health issues as well as AMCP s priority legislation. So there was an attempt as part of the government funding process in March to include some health legislation that was not successful. So we are targeting aiming for the lame duck session after November's election, that period between Election Day and the seating of the new Congress in January of 2025. It looks like there's a favorable chance that there will be some sort of year end health care package. As part of the government funding process. In March, there were a number of health extenders that were included in that appropriations bill for health and human resources or Health and Human Services. And those extenders all expire on December 31. So they are going to need to be re upped. And that's a really good opportunity to get any sort of priority legislation in. If I were a gambling woman, I would put my money on some form of PDM or form being included. We obviously at AMCP are going to strive to include our legislative priorities as well.

Fred Goldstein 02:19
And so what are some of the priorities you have now?

Jennifer Mathieu 02:22
So we have several priorities, on the legislative front, we are actively engaged and supporting the access to Prescription Digital Therapeutics Act of 2023, or PDT bill and what the PDT bill does is it creates a benefit category for prescription digital therapeutics under Medicare and Medicaid. This benefit category is essential for CMS to be able to cover and reimburse for prescription digital therapeutics. Now, I will note for your listeners the difference between a digital therapeutic and a prescription digital therapeutic This is very important to AMCP. The PDT is a digital therapeutic that is reviewed and cleared by FDA and is prescribed by a healthcare provider. So different than some of the non prescription digital therapeutics. One thing that's important about this bill is it does not mandate that CMS cover or reimburse for these therapeutic products, it just gives them the pathway that they don't currently have to do so. So it's very important for a lot of the challenges our healthcare system is facing these days, which access issues because of you know, provider shortage or geographic location. These PDT's which for the most part are available on your cell phone, they're available on an iPad and they're available 24/7 Many of them treat various mental illness and as well as certain other behavioral health issues. Some treat chronic diseases like diabetes, cardiovascular disease, eye disease, there's there's there's quite a few. And so why we are such a supporter of this bill is because one of AMCP's broad organizational strategic priorities for several years now and continuing is to help address disparities in medication use and access. And we view the PDT bill as one legislative endeavor to be able to encourage greater access.

Fred Goldstein 04:36
And I think it's important as you point out, these are FDA approved, there are hundreds and hundreds of these digital therapeutics coming out. And I've been looking at him for years, and most of them don't have any research behind them. And they end up in the app store. And you're really, you know, playing with who knows what. So requiring that FDA approval is obviously critical. And then yeah, I know a lot of companies out there that are going that route and they're trying to figure out what's the pathway How do I Get there. Ultimately, somebody's got to reimburse for this. I do think just as you've talked about, they're a great opportunity to deal with the health equity issues and disparities, we see, the majority of people in the US today have a cell phone. So being able to access these apps just as you would versus some of the difficulties, sometimes people have accessing pharmaceuticals, etc, or getting to a doctor to get a prescription for that maybe they can get that prescription digitally, and then use it.

Jennifer Mathieu 05:23
Absolutely, absolutely. And you know, what's really important about this bill is there currently is an access disparity to PDT's there are several commercial plans that do cover and reimburse for them, which without that benefit category, we can't have coverage, we can't have the reimbursement for our beneficiaries of Medicare and Medicaid. So there's already a disparity in Access. And we are advocating for this bill to in hopes to correct that.

Fred Goldstein 05:51
Oh, fantastic. And so obviously, PDT's are one area, what's another one, you're focusing on?

Jennifer Mathieu 05:54
the Medicaid VBPs for Patients Act. And that's a mouthful to say. So we refer to it as the MVP act. And what this bill does, is, again, it's it's a theme of addressing access disparities. What this bill does is it really promotes and incentivizes the use of value based purchasing agreements in Medicaid, it's possible for Medicaid plans to engage in value based purchasing agreements. But we have not seen the uptick or the uptake in these agreements by Medicaid plans. So what this bill would do is it would codify the Medicaid best price rule, and that permits or provides a certain level of protection for the Medicaid plan with regards to cost coverage. It provides them some protection where they're not going to have to pay if the therapy is not effective. The therapies in mind when we're talking about the value based purchasing agreements, are typically cell and gene therapies, very, you know, long development time, very high cost associated with the development with the creation. And with, of course, the administration of these of these medications. I mentioned at the top this was another access issue is we want to ensure that Medicaid patients have access to the cell and gene therapies. Many of them address oncology issues, and many of them are for rare diseases to populations of patients that we want to ensure have access to the best treatment for them. So this bill would really help reinforce, incentivize a little bit provide some cover, help support the uptake of value based purchasing agreements and within the Medicaid program.

Fred Goldstein 07:44
Yeah, and I think as you pointed out, obviously, these things take a long time develop, they're very expensive, but they do provide a really unique value, as we're seeing with some of these new gene therapies. Many of them may, in fact, be cures. So giving the access to individuals with Medicaid is critical, but they are very expensive. So having a way to work that through the system is critically important.

Jennifer Mathieu 08:02
I think another really, you know, important point to make is that many times with cell and gene therapies, what works for one patient does not work for another patient. And obviously, a program such as Medicaid doesn't have a whole lot of excess funds to play around with. So, you know, we want to make sure that they have the protection and that the patients have the access.

Fred Goldstein 08:25
Another issue that's been resonating pretty strongly in his field, obviously, is this whole Medicare negotiating drug prices where are we with that.

Jennifer Mathieu 08:34
Yes. So AMCP has actually been following the Inflation Reduction Act, since the kind of surprise announcement the summer of 2022, that it was going to happen. We've been following it ever since. Obviously, the drug price provisions within the Inflation Reduction Act really hit home for our members, we have a very large percentage of our membership works for pharmaceutical manufacturers. The second largest, as you know, or equally large percentage works for health plans. So the drug price negotiation program that pharmaceutical manufacturers are currently experiencing, as well as the Part D reforms that will go live on January 1 of 2025. Those are impacting the majority of our members. We have started in early 2023. We started engaging with CMS, at minimum on a quarterly basis to share the concerns that we're hearing from our members. We've held a number of regular convenings throughout 2023. We have three planned for 2024 where we bring together the pharmaceutical manufacturers and the payers to have conversations, what's working, what's not working. What do you know health plans and payers need to know about the drug price negotiation program that's been very focused on manufacturers right now. But there will be downstream impacts across the entire prescription drug industry. And vice versa. We have these Part D reforms that are coming. manufacturers need to be aware of that as well because we are a whole ecosystem where we are impacted greatly by what happens to other people in the industry. So we have been very focused on communication with CMS hearing from our members, convening our members, and reporting back to CMS, what we're learning as well as providing education, it's so much education right now to our members. Our main goal in all of this is we want as successful in implementation as possible. And however we can facilitate that with our members with CMS. We are, we are doing and what are you hearing now where where are we with that process? So right now we're in the thick of the offer counteroffer offer counteroffer of the drug price negotiation program. So it's very focused on the manufacturers of the list of 10 drugs that CMS released last fall in 2023. There has been an initial offer made, a counteroffer, I think we're back to another counteroffer, I think we've got about three rounds of that before the MFP, or Maximum Fair Price of this list of 10 drugs is shared publicly on September 1 of 2024. So it's it's the back and forth negotiation between manufacturer and CMS right now. On the payer side, the plan side the Part D reforms. It's a very tight timeline for implementation. That timing was set in the law by statute with, you know, not a significant amount of input from CMS. So CMS is now tasked with implementing major reforms in Part D, in a very short amount of time. So education is key, not only of our members, but there is a level of education of the patient that health plans and payers are going to be responsible for come 2025. So you know, how can we best facilitate those communications as well support our members in the payer and plan space to be able to inform patients to understand every step of the implementation process themselves? It's daunting, we say in government affairs team at AMCP. We're constantly referring, as you know, these drug provisions within the inflation reduction act as the biggest thing since Part D was created.

Fred Goldstein 12:41
Right? Yeah. As a as a former health plan executive. I look at this in the implementation, it's a heavy lift. And as you said, it's a short time period. Let's touch on one more thing, the equitable community access for pharmacy services.

Jennifer Mathieu 12:54
Yes, the ECAPs bill. So this is a bill that AMCP is collaborating with our pharmacy friends at APHA, the American Pharmacists Association, and ASHP, the hospital pharmacists, and we are advocating for this bill, because it expands the scope of pharmacist practice at the federal level. And how it does that is during the under the Public Health Emergency during COVID. There were a number of authorities that were granted due to the public health emergency or PHE to pharmacists that allowed them to test, to treat and to immunize for COVID-19. And these authorities are either expired as of 12/31/23, or will be expiring at the end of 2024. And so what we're seeking to do is make these authorities permanent at the federal level, and to set kind of a standing expectation that the same authorities would be granted should another public health emergency, God forbid, ever be declared again. There are a few other diseases that are covered under this as well. Influenza, RSV, strep throat, some of these these authorities are not federally permitted. They are in many states at the state level, but we're looking to make them federal. And one final thing I'll say on it is it does also include reimbursement for pharmacists for doing these services, providing these services to patients. It provides reimbursement under Medicare Part B for them as well.

Fred Goldstein 14:39
As a final note, anything else you would like to add this morning's presentation was rapid, through a ton of issues, and as somebody in health care and trying to keep up with it. I watched and listened and realized how much of it I was not aware of, which is why it's so important to belong to groups like this and attend these meetings or have some sort of a way to get the newsletters etc, because it's so rapid coming out of DC and well now maybe we're in a slowing period. But there's so much up there, that keeping up with it is very difficult. So anything else you'd like to touch on?

Jennifer Mathieu 15:10
Well, I would say to to your point, and there's so many things that impacts the world of health policy that have nothing to do with health care. You know, if you look at Capitol Hill, if you look at the White House, we have an election year. So there's a lot of non health things that can impact what we can and cannot accomplish in the healthcare space legislatively and with regulations. The final note that I will say on one other kind of Top of Mind issue for AMCP is biosimilar adoption and uptake. You know, we've heard some recent news, just within the past week or two about one of the biosimilar products for HUMIRA and the uptick we've seen in those prescriptions. We are also engaged in a number of legislative activities to support biosimilar adoption and uptake. And one that I would mention actually relates to the inflation Reduction Act. There was a provision that essentially set biosimilar reimbursement at the average sale price or ASP plus 8%. Well, that's only in effect for five years as established by the Inflation Reduction Act. We're supporting a bill to extend that through 2032. We feel that that will help promote the adoption and uptake of biosimilars beyond the five year time period set by the IRA. And one other thing that I would note is we are also very engaged in the interchangeability of biosimilars; that discussion, CMS just had some recent activity, where they have allowed for biosimilar interchangeable at the counter for the reference product and eliminating switching studies for that. So we're trying to do whatever we can to support the adoption uptake of biosimilars. Few other bills we're focused on, we're very engaged in the regulatory front as well. But that's another story for another day.

Fred Goldstein 17:04
Well, we could obviously spend hours on this topic. And as I said, your presentation this morning was really fantastic. It provided me with a lot of insights into it. I want to thank you for joining us and sharing this.

Jennifer Mathieu 17:14
Great thank you so much for having me, Fred. It's been a pleasure.

Fred Goldstein 17:18
And thank you for joining us today. If you'd like the show, you can find all our episodes at amcp.org/podcast on our show page at Healthcarenowradio.com or on your favorite listening platform by searching Healthcare NOW Radio. You can follow our show social hashtag at #AMCPListenUp. And don't forget to share, like and follow AMCPorg on LinkedIn, Twitter, Instagram and Facebook. I'm Fred Goldstein for AMCP. Until next time!