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AMCP Legislative Update: Key Policy Priorities Part 1
Show Notes
Health care expert Fred Goldstein, host of the AMCP Podcast Series — Listen Up!, sits down with Adam Colborn, director of government affairs at AMCP, to discuss AMCP’s federal policy priorities in the 118th Congress. AMCP is focused on issues related to coverage of prescription digital therapeutics, value-based care in Medicaid, Medicare Part B provider status for pharmacists, and the implementation of the Inflation Reduction Act’s prescription drug provisions.
Transcript
[SPEAKERS: Fred Goldstein, Adam Colborn]
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 social #AMCPListenUp. And to learn more about AMCP, visit amcp.org. I'm your host, Fred Goldstein. My guest on today's show is Adam Colborn, Director of government affairs at AMCP. We'll be discussing AMCP's federal policy priorities in the 118th congress. Welcome, Adam.
Adam Colborn 00:33
Thanks, Fred. Glad to be here.
Fred Goldstein 00:34
Yeah, fantastic to get you on. Obviously, it's a big topic up there in Congress right now for the pharmacy work and other things that they're working on around health care. So why don't you give us sort of a high-level overview of what you're focusing on? Then we'll get into the specifics?
Adam Colborn 00:47
Yeah, absolutely. So AMCP is focusing on three major areas in the 118th Congress. Our top priority for this year and next year is the Access to Prescription Digital Therapeutics Act, which would create a benefit category for prescription digital therapeutics in Medicare and Medicaid. Our second priority is the Medicaid VDPs for Patients Act, which would expand the use of value-based purchasing arrangements in the Medicaid program. Our third focus area is pharmacist provider status. There's a handful of bills that we're looking at on this issue. The first is a Senate-only bill, which is the Pharmacy and Medically Underserved Areas Enhancement Act. The second, which is a bicameral bill, is the Equitable Community Access for Pharmacy Services Act. They're similar bills; they both focus on Medicare Part B provider status, but they differ in a couple of important ways. So that's what we're looking at on the legislative side. On the regulatory side, we are pretty much entirely focused on the implementation of the Inflation Reduction Act.
Fred Goldstein 02:01
Obviously, a lot on your plate right now. AMCP, focusing on a lot of areas that are extremely important when you think about that across the spectrum of health care. So, let's start first with the Access to Prescription Digital Therapeutics area. Want to discuss that a bit? Yeah.
Adam Colborn 02:16
So for our listeners who might not be familiar with Prescription Digital Therapeutics, before I jump into the bill, I'll just give a quick overview of what a PDT is. So a PDT is a software-based therapy that uses the software itself to deliver a clinical mechanism of action. These products are reviewed and authorized by FDA. And they're available only by prescription from a normal prescribing authority such as a physician or a psychiatrist. They are different from other types of health apps or wellness apps. If we think about something like a medical device, like an insulin pump, that has a phone app that lets you monitor your blood sugar and see your injection history and things like that, that would not be considered a PDT. That's a software that's sort of incidental to the clinical benefit being delivered directly by the device. Other types of wellness apps like things that help you remember when to take your prescriptions or when your Apple Watch vibrates and tells you to stand up. Those are not PDT's either. So PDT's are very specific and treat a very specific condition. I won't spend a lot of time what conditions they treat, but there's a pretty wide variety. They treat things like post-traumatic stress disorder, and anxiety. There's a pipeline therapy for autism, there are a handful of ones that use a physical therapy approach for conditions like amblyopia or recovering from a stroke. So pretty wide variety of apps out there of PDTs. And right now, none of them can be covered under Medicare. Medicare is a defined benefit category. And so they lack the ability to cover anything that isn't in a list of statutorily defined benefit categories. benefit categories can be very narrow, very broad. It's not like Medicare Part E or anything like that. It's really just a list of services and products that's defined somewhere in the US Code. And so what this bill does is it just adds Prescription Digital Therapeutics three words to the end of the list of benefit categories. An example of other types of benefit categories, is like diagnostic X-ray tests is its own benefit category, because when the Medicare program was first implemented, diagnostic X-ray tests were not widely used. So It was sort of outside the scope. The bill, the Access to PDTs Act defines PDTs using a two-pronged approach, which is, as I mentioned earlier, reviewed for safety and efficacy by FDA. And then available by prescription only. So there are a handful of digital therapeutics that have received FDA authorization, but are available sort of over the counter. And those are outside the scope of this bill. So this bill is only focused on those that are available through a prescription. It also includes parity for Medicaid. Medicaid has the waiver process which can be used to open up coverage on a sort of a product-by-product basis. But it's a lot of work. You know, the system is not really set up to facilitate coverage at the Medicaid level of PDTs right now. And so this just expedites the Medicaid ability to cover them as well.
Fred Goldstein 06:03
And what has been the support in Congress?
Adam Colborn 06:06
So the support has been good. This is the second time this version of the bill has been introduced. It was introduced in the 117th Congress as well. Most of the folks who have come on board this year were folks who are on the 117th version of the bill. And so it's a strongly bipartisan bill. If anyone wants to look up the bill number, it's HR 1458 in the House, and S 723 in the Senate. But in the Senate, it has five co-sponsors right now.
Fred Goldstein 06:47
And are you looking for individuals? Is there a group going together and saying, hey, we'd like to get support from the others outside in terms of letters or things like that?
Adam Colborn 06:57
Yeah, so AMCP is advocating for this bill in our individual capacity as an organization. But we're also a member of a coalition in support of this bill. So the coalition is comprised of largely manufacturers, so the companies who make the PDT products, but we also have patient groups for the conditions that are treated by these products in there as well. And then AMCP is the leading payer voice in the coalition. And so we do a lot of work together as a coalition. One example is, recently at the end of June, we held a Demo Day on the Hill, we were in one of the House Office buildings, and we had 10 PDT manufacturers bring in their products, and display them and demo them directly with congressional staff. And that's the, you know, that's been, I think, really helpful in our pursuit of co-sponsors. So in the house, we have 18. co-sponsors, so a little bit more than in the Senate. And most of the folks who attended that demo day were House staffers. And it's difficult to get your head around these products if you don't sort of live in this space on a daily basis. So that's been our biggest obstacle is just getting folks to understand what a PDT is. So working with the coalition to facilitate demos and events like that has been really helpful.
Fred Goldstein 08:40
I think that's really good news. I know, as you've mentioned, more and more of these are coming out, they're gonna go through FDA approval, they clearly are a benefit in those cases where they've done that, and I think it's important, obviously, to get these added. So what are some of the other areas you were working on your check out the Medicaid Value-Based Payment issue? What is that?
Adam Colborn 09:00
So the Medicaid VBPs for Patients Act or the MVP Act, is a bill that would codify the Medicaid multiple best price rule, which was implemented in 2020. You know, the multiple best-price rule is pretty niche. And it's, it's sort of a weedy subject. So it's impossible to explain it in sort of a one-sentence way. Essentially, what the multiple pest price rule did was allow pharmaceutical manufacturers to report two different best prices to the Medicaid program, one under a traditional fee-for-service structure and then another under a value-based structure. And that was important because before the multiple best price rule one there was only a single Medicaid best price, pharmaceutical manufacturers were reluctant to enter into value-based arrangements with anyone in the country, so not just Medicaid programs, but commercial insurers as well. And the reason for that is, you know, in the event that a drug, you know, a high cost therapy totally failed for a patient and the payer ended up paying $0 on the drug, either through a reimbursement or rebate, or, you know, not making incremental payments, or whatever the structure is, the manufacturers were worried that that would set the new best price under Medicaid at $0. And Medicaid is entitled to the lowest price paid by any entity in the country. And so that that was a concern for manufacturers. And so they weren't coming to the table to negotiate these types of contracts. So the multiple best price rule was implemented in 2020, was finalized by the Trump administration. And then in 2021, the Biden administration made some revisions to it, which were fairly minor. But in early 2022, the Biden admin also released a couple of technical guidance documents, one for manufacturers and one for state Medicaid programs. And that contains a lot of really important clarifying information. You know, unfortunately, after the 2020 implementation of the multiple best price rule, we saw manufacturers really open up to using value-based arrangements on the commercial side of things, but that hasn't extended into the Medicaid space. And so the, you know, the Biden admin was trying to to encourage that through its guidance, but it hasn't had the effect that we were hoping for. And so we're working with Congressman Guthrie in the House. He's the lead sponsor. He's a Republican from Kentucky. And then Congresswoman Anna Eshoo, who's a Democrat from California is the lead Democrat on the bill. And so there's only a house version right now, we're working on Senate introduction. So hopefully, we'll have some good news soon on that. But really, the goal of the bill is to codify the rule, and incorporate all of the useful things from the Biden administration's guidance that are right now nonbinding. Hopefully, it will provide the stability that all the stakeholders need to allow Medicaid and pharmaceutical manufacturers to negotiate these contracts. I think the bill is important for a couple of reasons, for Medicaid programs. One, it expands patient access to high-cost therapies, as we see more cell and gene therapies, for example, coming to market, many of those products will only ever be available under a value-based purchasing arrangement. And there is technically some weird math that CMS can do to approximate a fee for service price point and pay for it. But that's not a very good approach when we're dealing with therapies like this, especially in the rare disease space where patient outcomes can be highly individualized. And so it expands patient access in Medicaid, but it also protects Medicaid programs from paying for these drugs, if they don't work, or if they work at a lesser degree than is expected. Medicaid programs operate on very thin budgets. And so they are not well positioned to absorb the, you know, a potentially million-dollar price tag for a drug that doesn't work. If it works, that's great. And that's, you know, that's worth the money. But if it doesn't work, we don't want them to have to be on the hook for something that failed.
Fred Goldstein 13:53
Right, and, and this really is critical if we want to move to these outcomes-based approaches of payment and Value-Based Payment Models versus dropping the fee for service bill for another CPT code or another NDC code or something like that, obviously,
Adam Colborn 14:06
yeah.
Fred Goldstein 14:08
And do you think that you'll be able to get someone in the Senate to put this up and get some similar language and start moving this along?
Adam Colborn 14:15
I do. So I don't want to say too much at this point, because it's not set in stone. But I think we're in a good position to see an introduction in the fall on the Senate side. We have a couple of bipartisan offices that we've been speaking with, and it seems like things are headed in that direction. I think another reason that I expect to see the Senate take this up is that it's moving pretty quickly through the House. So it's been voted out of full committee. So for those who are not super up on their legislative process, in the House, a bill moves to it first goes through the subcommittee review and then the subcommittee will send it to the full committee for review and possible amendment. And then the full committee will send it either, you know, they'll vote it down, or they'll send it to the House floor for a vote from the full chamber. And so it moved out of full committee, which is the Energy and Commerce Committee in May of this year. So it moved pretty quickly. And we expect to see a floor vote sometime this fall, maybe not in September. So the House and Senate have just gone on August recess. So there won't be any votes until they get back in early September. And there's a couple of sort of high profile budget and defense issues that need to be resolved right away when they get back. So I don't know if we'll see a floor vote in the House in September. But, you know, October, November, I would expect to see this taken up by the full House. And then, you know, whether the Senate has introduced its own version or not, at that point, it will go to the Senate for it'll automatically move to the Senate. You know, I do think there's a pretty good chance that we see a Senate version in one form or another before the end of the year.
Fred Goldstein 16:14
Just fascinating information. Thanks so much for joining us, Adam. Thanks Fred . And thank you for joining us today. If you 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's 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.
About the Hosts
Fred Goldstein is the founder and president of Accountable Health, LLC, a healthcare consulting firm focused on population health, health system redesign, new technologies and analytics. He has over 30 years of experience in population health, disease management, HMO, and hospital operations. Fred is an Instructor at the John D. Bower School of Population Health at the University of Mississippi Medical Center and the editorial Board of the journal Population Health Management.
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