Maureen Testoni Recaps 340B for 2020

David Glendinning (00:00): Hi, it's David Glendinning with 340B Health. Before we start the show, I wanted to note that we're planning episodes for 2021, and we would love to hear from you on what topics you want discussed on 340B Insight in the new year. Please email us at podcast@340bhealth.org. Thank you, and we look forward to hearing from you. Speaker 2 (00:26): Welcome to 340B Insight from 340B Health. David Glendinning (00:34): Hello from Washington, DC. And welcome back to 340B Insight, the podcast about the 340B drug pricing program. I'm David Glendinning with 340B Health. This episode is sponsored by Capture RX. For more than 20 years, Capture RX has helped safety net providers and pharmacies achieve their objectives through leading 340B solutions. Their solutions handle the complicated, time consuming tasks associated with 340B compliance, giving you more time and resources to achieve your mission and do what you do best: care for patients in need. David Glendinning (01:13): Our guest today is Maureen Testoni, 340B Health's President and CEO. We spoke with Maureen about a major development in the response to recent pharmaceutical company denials of drug discounts, as well as some of the other big news for the 340B program that occurred in 2020. Our special episode last week gave you some of the details of the new lawsuit 340B Health filed in federal court on this issue. So be sure to check that out if you haven't already. And because there is so much going on in the 340B world these days, another major development occurred literally while Maureen was sitting in the virtual podcast booth with us. David Glendinning (01:51): 29 state attorneys general sent a letter to the heads of HHS and HERSA calling for action against drug companies that are refusing to offer discounted pricing on drugs dispensed to contract pharmacies. The letter from the top state lawyers is very strongly worded describing the manufacturer actions as egregious and unlawful. It recommends that HHS consider imposing civil monetary penalties on companies that are overcharging 340B hospitals and other covered entities. Among the lead authors of the letter is California attorney general Javier Bissera. If you recognize his name, it could be because President-elect, Joe Biden has tapped Bissera to be his nominee for health and human services secretary. So his prominent presence on this letter to the cabinet secretary, whom he aims to replace, is a very important piece of information for hospitals that are wondering about how the incoming Biden administration might consider 340B issues. Check out the show notes for this episode to read the letter. David Glendinning (02:57): And now for today's feature interview with 340B Health President and CEO, Maureen Testoni. This is the third time we have spoken to Maureen for the show this year. We thought it was the perfect time to have Maureen back to discuss all the big 340B events that happened over the course of 2020, during a month when it does not appear that the pace of the news is slowing down at all. Among those developments is the filing of the federal lawsuit over the 340B pricing dispute, which Maureen mentioned in the special episode we released last week, and that she will speak more about shortly. We also chat about what 2021 might bring for 340B hospitals. Our own Miles Goldman sat down with Maureen to discuss all of this. Let's hear that conversation. Miles Goldman (03:43): Thank you, David. I'm Miles Goldman with 340B Health. I'm joined again by Maureen Testoni, the President and CEO of 340B Health. We are now clearly in the next wave of the COVID-19 pandemic and public health leaders are warning that it will be more difficult than the earlier waves. How are 340B hospitals using the program savings to confront COVID-19? Maureen Testoni (04:09): So 340B hospitals have been telling us that they're using their 340B savings to try to expand care to their patients. So one way that a lot of them have done this is through telehealth. They have been adopting different areas of the hospital so that they could turn it from in-person care to telehealth care. They've also used it to enhance medication therapy management services, which include calling patients to make sure that they are in fact, getting their medications and taking their medications. We're also aware of lots of different examples of specific things that hospitals are doing. For example, a hospital in Texas work with their city to turn the convention center into a homeless shelter where the hospital could then provide outpatient services directly to the people in that shelter. And they use 340B savings to help them do that. Maureen Testoni (05:05): Another story we heard about was a hospital in Kansas, where they were able to open additional wings of the hospital to be able to provide more care to patients. So as they were filling up with COVID 19 patients, they really had to keep those patients separate, but you still have people that have heart attacks and strokes and other things that need to be in the hospital. So 340B savings, they said allowed them to open other parts of the hospital that were not currently being used. And then also to hire staff, to staff those parts of the hospital so they could continue to provide care to their patients. Maureen Testoni (05:40): We also hear from a lot of rural hospitals that have been telling us that 340B is really what helps keep them open during times of crisis like we're seeing right now. So we're really pleased that HERSA has extended flexibility to 340B, made it very clear that 340B is definitely something that can be used in conjunction with telehealth. And they've also given them some flexibility around the use of 340B when there are drug shortages. Miles Goldman (06:10): I'd like to return to our discussion from our breaking news episode last week about drug manufacturers refusals to provide 340B discounts when drugs are dispensed at contract pharmacies. What can 340B hospitals do to continue to access program discounts? And what can they do if additional drug manufacturers take action similar to the ones we have already seen? Maureen Testoni (06:36): We start by having hospitals file notices of overcharge, which you can get from the website of the [Apexas 00:06:44] prime vendor. And you fill out that paperwork and you submit them to person, person takes those and then they contact the manufacturer and they start the process of enforcing. We recently received a letter from Admiral Krista Pedley with her son, and she assured us that they are following up with current entities to get all of the details. So we strongly encourage people, if you have been overcharged for one of these drugs, or if you have tried to buy drugs at the 340B price and been denied, really, really encourage you to submit those notices. Miles Goldman (07:19): Looking in the months ahead, what are some steps hospitals should consider when advocating on this issue? Maureen Testoni (07:28): We have a new Congress, we have a new administration. So there's a lot more that we will need to do to educate the new members that are coming into the Congress, as well as the new administration about 340B, about what it does to help low income patients, what these actions by the manufacturers to just take the law in their own hands and decide they're just not going to follow it. What that means, hundreds of members of Congress wrote to the administration about it, over 1,000 hospitals wrote to the administration about it. So we're going to have to do something similar in the months ahead in terms of really making clear what this issue is and what we need to happen in order to turn it around, which is we need the Department of health and Human Services to start enforcing the statute and requiring manufacturers provide 340B pricing again. Miles Goldman (08:20): And taking a look at another issue related to drug manufacturers. Kalderos is working with drug manufacturers to turn 340B into a rebate program. What are your concerns about what Kalderos and its manufacturer clients are doing, and how is 340B health responding to this issue? Maureen Testoni (08:41): So I had some very big concerns about the idea of 340B being turned into a rebate program. One of my big concerns that it's going to make it difficult and we're expensive for 340B hospitals and community clinics and the others that are part of 340B to actually access the 340B savings. They would have to pay for these drugs at the high wholesale acquisition costs, which is like the sticker price on a car for a drug. They would have to pay that and then they would have to wait, apply for rebate after that, and then wait to get the rebate. So there's always going to be a lot of money floating out there to the manufacturers in order to be able to secure rebates down the line. And that's very concerning to me. I've heard of estimates where for some systems, larger systems, this could be millions. So that's very, very concerning. Maureen Testoni (09:34): Another big concern is that the way this model is talked about, manufacturers will not always grant the rebate. There could be situations where according to the manufacturer's rules, that they will not grant the rebate. And given that there's been no guidance, no regulation, no nothing out there from the Department of Health and Human Services, it's unclear what kind of rules even apply or how it would work if the manufacturer denied a rebate and then the hospital had to challenge that denial. And that's another one of my big concerns about this is, is this something where since the beginning of the program, HERSA, the government has been very clear. Manufacturers have to participate in 340B as an upfront discount. There is a very small, small program where a rebate is allowed among payers, but not like this, where it's the provider and the manufacturer. Manufacturers have asked for this and they have been told no repeatedly. Maureen Testoni (10:38): So in the absence of any kind of, of guidance out there, any kind of proposed guidance that has gone through a public comment period so that all the stakeholders could really talk about what their concerns are. And then HERSA would take that information and come up with some kind of guidance so all stakeholders understand what the rules are, what kind of oversight HERSA would be providing. Without anything like that, it just is very concerning to think that manufacturers could all on their own, make such a drastic and dramatic change to 340B. Maureen Testoni (11:13): So we have contacted HHS, making very clear what our concerns are on this and hoping that HHS will not permit this to go forward, or at least not permitted to go forward in the absence of any kind of public notice and comment periods so that HERSA can actually have some guidelines on this. There have also been letters sent to Secretary [Azar 00:11:38] from members of Congress on this as well, that have expressed significant concerns with this kind of a proposal. To date, HHS has not yet come out with any guidance on this issue, but it is very concerning. Miles Goldman (11:51): And that letter that members of Congress have sent, that was nearly half the House of Representatives. Maureen Testoni (11:57): Exactly right, yes. Tremendous, tremendous support for covered entities by this Congress. And a lot of concern about manufacturers changing the rules and specifically with Kalderos. Miles Goldman (12:12): What would you suggest 340B hospitals do if Kalderos or a drug manufacturer asks them to participate in the 340B Pay software? Maureen Testoni (12:23): So 340B Pay is just a name that they use, it's the marketing name for their software. My advice is if Kalderos or drug manufacturers or anybody is asking a hospital to participate in any kind of special program or use special software or anything like that, that you request a copy of the terms and conditions and review those with your counsel. We have seen situations where manufacturers have asked, I mean not just Kalderos, but in other situations where manufacturers have also asked covered entities to provide in different software and just share information. And when you look at the terms and conditions, it's really imposing, binding legal obligations on hospitals. I would strongly suggest that before you agree to anything that you really print it out and work with legal counsel to review what those terms and conditions really mean for your institution. Miles Goldman (13:23): Looking ahead to the new year, what keeps you up at night and what are you hopeful for when it comes to hospitals that participate in the 340B drug pricing program and the patients they serve? Maureen Testoni (13:36): Well, certainly the actions of the drug company isn't to refuse to provide the 340B discounts, is keeping us all up at night. That's why we filed our lawsuit. It's extremely, extremely concerning for our hospitals and other providers of 340B or in the 340B program. But every crisis has a silver lining. And I have been very grateful for the outpouring of support for 340B from organizations across the country and from our electric representatives in Washington. When we speak as one voice, I know we're powerful and we are heard. Miles Goldman (14:13): Maureen, thank you for taking the time to provide your expert analysis for our listeners. We're looking forward to having you on again in 2021, to continue to provide us updates as new developments emerge. Maureen Testoni (14:26): Thank you so much for having me, Miles. It's been a pleasure to be on the show. David Glendinning (14:31): Our thanks again to Maureen Testoni for joining us again and for scoring the podcast equivalent of a hat trick this year. We look forward to checking back in with Maureen from time to time during the 2021 season of 340B Insight. Do you want to learn more about the federal lawsuit 340B Health and other hospital and pharmacy organizations filed this month? Then be sure to join us for a member only webinar on Thursday, January 14th called 340B In The Courts. Our panel of legal experts will cover not only the latest litigation, but the full evolution of court activity around 340B that has occurred since the program started in 1992. Take a look at the show notes for the link to register for this webinar. David Glendinning (15:17): If you missed some of our other recent episodes, be sure to catch up. We recently spoke with Northwell Health's [Staniel Sastillo 00:15:24] discussing how the New York health system has maintained strong 340B operations and compliance during COVID-19. We also recently published an episode discussing what the Biden administration and a new Congress could mean for 340B. It's hard to believe that this is the 17th episode of 340B Insight since we launched the podcast back in May. We have been thrilled by the positive reception we have received to this podcast and our growing list of subscribers. We are grateful to our guests for sharing their informative, remarkable, and inspiring stories and we eagerly await the opportunity to hear more. David Glendinning (16:04): We already are planning a full season of episodes in 2021. As always, we welcome your episode ideas and feedback. You can email us at podcast@340bhealth.org. We are heading into the longest night of the year here, but with it comes the knowledge that the days will start getting longer again. We here at 340B Insight wish you and your loved ones, peace and good health during this holiday season and best wishes for the new year. We'll be back in January. Until then, thanks for listening and be well. Speaker 2 (16:45): Thanks for listening to 340B Insight. Subscribe and rate us on Apple Podcasts, Google Play, Spotify or wherever you listen to podcasts. For more information, visit our website at 340bpodcast.org. You can also follow us on Twitter at 340B Health and submit a question or idea to the show by emailing us at podcast@340bhealth.org.