Learn about developments in federal legislation and regulations within the pharmacy landscape shaping the future of managed care in an interview with a session presenter from AMCP 2024. 

[I’m] Jennifer Mathieu, I'm the Senior Vice President of Professional and Government Affairs for AMCP. And I have been in managed care for 15 years and managed care pharmacy for the last 4 [years]. 

Can you describe the current state of prescription digital therapeutics in federal legislation and regulations? 

Digital Therapeutics in general is a relatively new class or category of treatments and AMCP is particularly interested in prescription digital therapeutics. The differentiation between the two is prescription digital therapeutics are, one, reviewed and cleared by [the] FDA and then prescribed by a health care provider. And we are kind of one of the lead proponents of the Access to Prescription Digital Therapeutics Act of 2023 which is a bipartisan, bicameral piece of legislation that would create a benefit category for PDTs within Medicare and Medicaid. We feel that this is a really important bill because it allows a pathway for CMS to cover and reimburse for PDTs. 

The current state of the legislation is we are in year two of the 118th Congress and we are working with our partners on this bill, various PDT manufacturers, the Digital Therapeutics Alliance, and, obviously, patient advocacy groups. And we are, we're advocating for this bill because there is currently a disparity between who has access to PDTs. There are certain commercial plans that are covering PDTs, but Medicare, Medicaid does not have this pathway to cover them or reimburse them yet. So we are hoping that we will see success before the end of 2024 with this bill. And the big reason, not only to eliminate this disparity in access, but also because of what PDTs treat. Many of them are for various mental health issues. Some are for chronic diseases like diabetes, cardiovascular disease, insomnia. And so we are very supportive of this bill, advocating very heavily for it. We'll actually be on Capitol Hill next month with this as one of our primary asks of legislators. And yeah, we are just very hopeful that we're going to see some good forward progress this year.

How do value-based arrangements in Medicaid impact managed care pharmacy practices? 

The value-based agreements in Medicaid is relatively new in the Medicaid space. And we haven't seen as robust of an uptake in value-based agreements in Medicaid. And we would like that to change, particularly with the forthcoming cell and gene therapies, many of which are incredibly complex and very costly. We are advocating for the Medicaid VBPs Act of 2023, which is otherwise known as the MVP Act. And what this bill would do is it would incentivize the greater uptake of value-based purchasing agreements in Medicaid. It would codify the multiple best price rule, and that would just create a much smoother pathway for Medicaid plans to engage in value-based agreements. We think this is really important with what we know is over 300 cell and gene therapies coming down from [the] FDA. We feel it's incredibly important for Medicaid patients to have access to these various therapies, primarily because the majority of them either treat oncology or they treat rare diseases. And so we are trying to correct that disparity in access so that it is kind of even playing field for the Medicaid patients. 

What are the challenges faced in improving access to biosimilars in the current regulatory environment? 

I think what we're seeing right now is slow adoption, slow uptake of biosimilars. Obviously, something that AMCPU wants to change, we have been very invested in biosimilars since we created the Biosimilars and Biologics Collective Intelligence Consortium, or BBCIC, for ease, in 2015. They are the leading researchers on biosimilars and biologics. And so we feel it is really important to address some of the barriers to biosimilar adoption and uptake. 
Some of those barriers include interchangeability. There is a bill out there right now that we are in support of that would basically change the definition of interchangeability. It would allow a biosimilar to essentially get the same level of FDA approval as its reference product. And so we are supporting that. We are also supporting a number of study bills that would further advance the biosimilars market. And we are also supporting an extension of the Inflation Reduction Act's average sales price plus 8% rule, if you will, that allows greater incentives for biosimilars. We are supporting a bill that would extend that ASP plus 8% to 2032. So that's where we are with the biosimilars space right now. 

What is the significance of the Inflation Reduction Act for managed care pharmacy professionals? 

Huge, in one word. So the Inflation Reduction Act is something that AMCP has been following since the day it was signed into law in August of 2022 because it will have such an impact on our members. There are multiple provisions, but there are two main provisions that we have been following. I'm going to mess this one up. It's what we call the MP3, which is the Medicare Prescription Payment Program. And that essentially is a part D reform. So it's the reforms that are being made to the prescription drug benefit. That is going to greatly impact all of our members that are working for health plans. And it goes into effect 1/1/25. So there is a lot of education, there is a lot of learning, understanding, a lot of conversations that our members are having with us, that we're having with CMS, and is impacting such a huge percentage of our members.

The other side of the drug price provisions are related to all of the pharmaceutical manufacturers. Again, many of our members work for pharmaceutical manufacturers, and that is the Drug Price Negotiation Program, which I think a lot of folks have heard about quite a bit about where the federal government gets to negotiate the price of the top 10, or I guess I should say the list of 10 drugs that they released last September. Currently, we're in a little bit of a lull in that period for anybody who is not a manufacturer with a drug on that list of 10, or CMS, the government. They are in a back-and-forth process right now, where an offer has been made, a counter offer, I think we're back to the offer or the second round of offer, we expect counter offers. That's going to have huge implications for all of our pharmaceutical manufacturing clients, not just the 10 on the list because wherever that price ends, it's the maximum fair price, the MFP. Wherever that ultimate price ends up—which we're expecting it to be announced on September 1st of 2024—wherever that ends up, we expect there to be kind of outside impact on other products, either by those manufacturers or other manufacturers with products that do similar things. So again, like I said, we have been very engaged in conversations with our members on the manufacturing side as well as on the health plan side. Over the past two years, year and a half to two years, we've been involved in a lot of conversations learning what are their pain points, what's keeping them up at night, and how can we help support them either through education. And also engagement with CMS is sharing the concerns that our members have, sharing the questions that they have, and kind of serving as that convener, that go-between individual or entity with CMS. 

How are pharmacy benefit managers affected by federal policy actions under consideration by Congress and the Administration? 

Another subset of our membership works for pharmacy benefit managers. And there are so many different pieces of legislation out there both at the federal level as well as at the state level that are striving to change how PBMs do business. And there's some common themes throughout, certain provisions that are similar across multiple bills, but some of the main themes that we're seeing relate to delinking which would impact the way that pharmacy benefit managers carry out their negotiations and how they determine their prices. There's delinking, transparency is a big piece of these bills as well. A lot of reporting requirements and provisions for PBMs to the government as well as to the public. There are, I mean, there's so many different bills that are inevitably going to impact how pharmacy benefit managers do their jobs, do their work, and how they strive to help support the health care system and industry as a whole. I would say that it's probably likely that we will see some form of PBM legislation as part of the 118th Congress before they leave, if you will, before they finish out 2024. We are thinking that there probably will be a year-end health care package, and some form of PBM reform will probably be in it. 

What are the key priorities of AMCP in advocating for federal legislation and regulations relevant to managed care pharmacy? 

Two of them I've already talked about, the Access to Prescription Digital Therapeutics Act of 2023 is a huge priority for AMCP. The Medicaid value-based purchasing agreements bill, the MVP act of 2023 is also another huge priority of ours. I mentioned a few biosimilars bills that we're focusing on. One thing that I haven't mentioned is actually something in service to the profession of pharmacy as a whole. It's the Equitable Community Access to Pharmacist Services Act of 2023. We call it ECAPS for short. And this is a bill that AMCP is supporting the American Pharmacists Association and the Association, oh gosh, let me, I'm sorry, I'm going to get this acronym wrong. It's the American Society of Health System Pharmacists. We are advocating along with other pharmacy associations for this bill because what it would do is it would make permanent the provisions that were part of the public health emergency during COVID for pharmacists to test and treat and immunize for not only COVID, but the flu and RSV, so on and so forth. It would make permanent those permissions to provide this care to patients, and it would also allow for reimbursement under Medicare Part B, as in boy, for those services. 

One thing that I think is really interesting is that pretty much 90 % of the American population lives within five miles of a pharmacy. And so the access to health care that this would allow for in making permanent some provisions that expired at the end of 2023 and some provisions that are going to expire at the end of 2024, it would really help the access issues in this country. So we are huge supporters of that.

I mean, I would say I think there's a general theme through all of our bills and that's access. Helping to address some of the access issues that we have in this country to health care. And in our specific niche, it's therapies. Medications and therapies. And I think between the PDT bill, the MVP Act, ECAPs—all we're striving to do is move the needle to improve access for Americans across the country.