Title Slide:	Remote Health Meeting May 24, 2021

Sevgi:	Hi everyone. Welcome. I am [inaudible 00:00:05], and I want to welcome you to the second day of our remote health meeting. I am looking forward to another wonderful day. Our speakers and organizers have been just extraordinary yesterday. We are going to start today with a panel discussion on regulatory issues, and Naomi Seiler was kind enough to organize this panel. I'm going to turn it over to Naomi. And as we did yesterday, as you finish your session, please introduce the following session because we don't have any chairs to do the transitions. Thank you very much. Naomi, it's all yours.

Naomi Seiler:	Thank you so much and good morning. So I know that yesterday, a lot of people touched on various regulatory issues in the context of their presentations, but I know that these can be complex. They can vary and people still have many questions about them, particularly as they evolve through the course of, and hopefully beyond, the most acute parts of the pandemic here in the US.

	So I'm thrilled to have organized this panel. We have three wonderful presenters. In the interest of time, I'll keep the introductions quite short and let them speak much more about their work. But our three presenters today are Dr. Hank Chaudhry, who has been the President and CEO of the Federation of State Medical Boards since 2009, representing all of the state medical licensing boards in the US, Karen Lovitch, who serves as chair of Mintz's Health Law and Healthcare Enforcement Defense Practices with deep regulatory knowledge, some of which she will share with us today regarding FDA and home testing, as well as other areas. And Adam Sonfield, from the Guttmacher Institute, who has been there since 1997 and serves as the executive editor for policy analysis, leading the institute's analysis on sexual reproductive health and rights.

Slide Description:	Diagram with “Remote Care: The Regulatory Context” overlapping “Regulation of Home Tests,” Privacy & Minor Consent,” and “Provider Licensing.” They are all surrounded by “Access to Technology,” “HIPAA,” and “Reimbursement.”

Naomi Seiler:	I will share my screen, which I hope will work. And we will start with... Give me just a moment, please. I was asked to put together a slide to represent sort of the full view of what we're covering today. And because I'm a lawyer and not a graphic designer, and the slides will look like that, but here is the visual that we put together to represent what we're covering. So the areas within the sort of Venn diagram, are those which our panelists will be focused on today. Regulation of home tests, provider licensing, and privacy and minor consent. There are of course, a vast world of policy issues related to access to technology, as well as reimbursement, which we will have a session on later today, and HIPAA, which we will touch on somewhat, but I think not exhaust. So without further ado, I'm going to turn to Dr. Chaudhry to start. And Dr. Chaudhry, I'm pulling up your map.

Slide Description:	U.S. Map showing Interstate Medical Licensure Compact as of April 16, 2021. The following 32 states have licensure enacted: WA, ID, MT, ND, SD, NV, UT, AZ, CO, WY, NE, KS, OK, MN, IA, WI, IL, LA, MS, MI, KY, TN, MS, AL, GA, PA, WV, MD, DC, VT, NH, ME. There is one territory shown (GU) that also has enacted compact licensure. The other territories (AS, NMI, PR, and VI) do not. There are 9 states where compact licensure has been introduced: OR, TX, MO, OH, NY, RI, NJ, DE, and NC.

	Reference: www.imlcc.org

Dr. Hank Chaudhry:	Great. Thank you so much, Naomi. Good morning, everyone. I have about eight minutes, so I will try to cover as much as I can, but try not to speed and talk too fast. I will add as my background, I am a general internist by training. I also have a background in public health. I'm a graduate of the Harvard School of Public Health and was health commissioner in Long Island during our last pandemic back in 2009, due to H1N1. Certainly, this pandemic is quite different. What's unique about this pandemic in particular, is how extraordinarily agile and nimble the state medical licensing boards have been. And that's not something that the licensing boards are known for, but pretty much right after the pandemic was declared back on March 11th of last year and after the national emergency was declared by our nation, every single state and territory also declared a public health emergency. And that allowed for a number of very rapid modifications to take place in regulations.

	We also saw a lot of early graduates from medical school. Fourth year medical students were allowed to graduate early. That happened in at least a dozen states, but then we had to suddenly figure out what title we would give them. And some states chose the title, "COVID-19 Junior Physician." But the idea was to have more people out helping in the healthcare workforce, especially back in March and April of last year, which seems like ages ago when it was such an epicenter back in the Northeast, in New York and New Jersey in particular. We also saw a lot of healthcare volunteers and retirees, people traveling across country to help out, which was wonderful. And the state licensing board were flexible in allowing that to occur in a sensible way.

	And we realized the value of data for some reason and I think our folks at the CDC know this. For some reason, when there's an emergency, a national emergency, or a regional emergency, or a natural disaster, sometimes not everyone who should show up to help, shows up. What do I mean by that is people who may have issues with their license, some sort of disciplinary history, it's not clear why they show up. Perhaps they're trying to redeem themselves, but it's critical that only qualified individuals are allowed to help. And it isn't somebody who has had some sort of encumbrance against their license.

	So as many states like New York asked for volunteers, they suddenly realized they didn't have the information to make sure that they were allowing the right people to practice medicine and basically engage in patient care. And so our data became very helpful at the FSMB. We have a fairly comprehensive database of every single licensed physician in the US and every single PA, physician assistant in the US as well. In fact, we partnered with HRSA. We got a grant from HRSA to create something called, providerbridge.org, for this national emergency and for future national emergencies, which is a robust database of credentials, not just names, but credentials for not only doctors and PAs, but also nurses and other healthcare practitioners as well.

	So this slide is my only slide for this presentation, is about the Interstate Medical Licensure Compact. I'm not sure how many in the audience are familiar with this, but this began as an idea in 2013. It was implemented in 2015 and became operational in 2017. Essentially, and I'm summarizing here in a thumbnail, the FSMB got the nation's licensing boards together in a room and said, "What are the most important criteria that you need to make sure that you license those who are qualified to license?" And we realized different states have different rules and requirements, but we boiled it down to nine criteria that everyone agreed to. And so if a physician meets those nine criteria, the participating states agreed to issue a license to practice medicine instantly. Not just telemedicine, the full practice rights instantly.

	And so since 2017, as you can see from this map, the dark blue states indicate the states that have fully adopted the interstate compact. And we have about nine states right now, that are in the process of introducing the legislation and adopting the legislation. I think, Texas is the closest. Their House of Representatives and Senate just approved it. So it goes through a process and ultimately, to its governor, but more than 20,000 licenses to practice medicine have been issued through this pathway. It's sort of like a TSA pre-check, is the way we promote it, that if you meet the nine criteria, you get as many licenses you want simply by checking off which state you want that license in. We're actually helping the PA community do the same to create an interstate compact for physician assistants. We think this is going to be helpful. It certainly was helpful during the pandemic when we saw a significant uptake in physicians seeking licenses through this compact.

	And that's important because one of the questions I get currently a lot is, "Well, all right, the states have made emergency changes to their licensure. They're allowing essentially in many cases, the unfettered practice of medicine, whether in person or by telemedicine, but what happens after the pandemic?" Well, after the pandemic, the compact will continue. And so that's one means by which a physician can lawfully practice medicine in multiple jurisdictions. And so I think, that's something to sort of be mindful of.

	And then speaking of telemedicine, I think it's important to know that we did see a significant uptake. I think you all know this. It was utilized for all sorts of acute and chronic care. And I think we're still trying to figure out to what extent it had benefits, and I think the industry is also looking at that as well. But clearly, telemedicine is here to stay. I think for a two-month period last year, back in March and April, there was actually more telemedicine in this country than in-person care. No one thought that would occur and it wasn't perfect, but it really demonstrated that there was a role for telemedicine.

	And so the FSMB, my organization, has created a work group to figure out some recommendations that we can make to the licensing boards about what to do post pandemic. And I think that's going to be important to try to sort out. Because right now, the states are sort of trying to figure this out. So for example, Vermont has said that it's going to create a process right now where they're going to extend the current emergency through March of 2022, as one example. So they're just sort of kicking the can a little bit down the road. Another example is West Virginia, which has decided that it's going to permanently create a process by which physicians can engage in telemedicine. As long as they're licensed in another state, they can do that in West Virginia with a registration. So it's not a full licensure, but a registration by which they can do that.

	And we may see several more examples of this. When we talk about telemedicine, I think the other point to be made is we're not just talking about regulation and licensure, although that seems to get a lot of attention. The other piece as to why we saw so much telemedicine are obviously, some of the regulatory changes that were made. As you know, HHS and CMS made changes to, or modifications to HIPAA, where they relaxed some of its sort of enforcement. Cybersecurity, privacy issues were... I wouldn't say they were less important, but recognizing that we were in an emergency, people were allowed essentially to be able to practice medicine using technologies that perhaps didn't have the necessary safeguards in place.

	So my own mother was in her 80s and Brooklyn was using telemedicine. She had never used it before and she was able to use it with her smartphone. And when I asked her, "Why did you do that? You never did it before." And she said, well, her doctor was using it for the first time, and that's wonderful. But then fast forward to today, and I asked my mom if she still does that, and she says, "Well, no, because now I can see him in person again." So we'll have to see how this plays out, but the state boards have to figure this out as well.

	I think the other point is broadband access. It's wonderful to have telemedicine, especially when it can be utilized appropriately for continuity care. There're other uses as well that we don't have time to go into, but we want to make sure that there's broadband access. And we want to make sure that people can afford to have the technologies in place. So I noticed the president's infrastructure proposal does have a significant amount of money dedicated to broadband. And I think that will certainly help our nation move forward.

	And then finally, in terms of lessons learned, there are many lessons learned. I think it is important to know that AI, artificial intelligence or augmented intelligence, may have a role to play as well, but it turns out for COVID, perhaps because it was so dynamic, it didn't really show up as being as promising as people thought, because things were changing so quickly. The algorithms basically, perhaps couldn't keep up. I think that's a lesson that you can't always rely on technology.

	I think the other piece is that despite technology, despite telemedicine and telehealth, we still had an opioid epidemic. In fact, the opiod epidemic, according to CDC data, got worse. And I'm sure we had other areas, cancer prevention, for example, became a concern as well. People who were scheduled to get their colonoscopies have decided to wait. And I think we'll have to see how that plays out in the years ahead. But I'm delighted to talk about regulation, delighted to share with you a snapshot of what the state licensing boards have been through. We're still examining the lessons learned and looking at the evidence because as we move forward, it's important for us to look at the science and the evidence. Thank you.

Naomi Seiler:	Thank you so much. And I'm supposed to note, and this pains me as a professor, that we're not supposed to take questions during these sessions just in the interest of time. But if you do put questions or comments in the chat, the CDC organizers will be compiling them and using that to kind of understand and figure out how to respond to where there's need and interest. I'm going to turn to Karen Lovitch.

Karen Lovitch:	Okay. Thank you. Being an attorney who practices in this area and has advised labs with pathologists serving patients all over the country for many years, and of course, telehealth providers who face the challenges that Dr. Chaudhry is discussing, it's very exciting, the work that he and his organization are doing to try to help solve this problem. So I've been asked today to discuss the basic regulatory framework that's applicable to at-home specimen collection/at-home testing. Obviously, I have a short span of time that's allotted to my remarks. So I'm going to focus on what is in my experience, the most common business model, which begins with a patient initiating a test order online. The laboratory will coordinate a short consultation with the clinician who orders the test and sends the patient a self-collection kit. The patient then sends the specimen back to the lab. The lab performs the test and typically, makes the result available to the ordering clinician and to the patient via a secure internet portal.

	So I think, one common misperception is that all diagnostic test kits go through the FDA process. That is actually not the case. While the FDA does review diagnostic test kits for clearance or for approval whatever the case may be, a laboratory can also use what is referred to as a laboratory developed test or an LDT. Now the LDT has a long tortured history at FDA, and there have been a lot of ups and downs in legislation, and guidance, and so forth. But I'm just going to stick to the basics here today and tell you that it's defined by the FDA. And LDT as an in vitro diagnostic test, it's manufactured by and used within a single laboratory. And similar to other in vitro diagnostic tests, FDA considers an LDT to be a medical device as defined by the law and regulations.

	And while the FDA does have jurisdiction over medical devices, including IBDs, it has historically exercised its enforcement discretion, which means the FDA has not enforced applicable provisions of the Food, Drug and Cosmetic Act or Medical Device Regulations with respect to LDTs. And so as long as labs develop their own testing technology and they use it only within their own lab and they do not sell it, the FDA will typically exercise its enforcement discretion. It has effectively advocated its oversight responsibility too at the Centers for Medicare & Medicaid Services, which regulates LDTs under the Clinical Laboratory Improvement Amendments in 1988, which is better known as CLIA.

	Many people are surprised, as I said, to hear that test kids aren't necessarily regulated by the FDA, and that labs choose to go this route. Now the CLIA program as I mentioned, it is within the purview of CMS, but it's administered at the state level under the overarching authority of CMS.

	And so what that means is that a different agency in each state is responsible for inspecting labs, and overseeing labs, and issuing the CLIA certificates per CMS guidelines. It's also worth mentioning that many CLIA certified labs are also accredited by a CMS approved organization, such as the College of American Pathologist. And what that means is if it's an improved CMS approved accrediting organization, that organization rather than the state, is typically overseeing regulation of laboratory testing by that lab. Now, if a lab intends to allow... Now, I think we all obviously know that lab testing is typically a patient gets a specimen drawn at a doctor's office or a patient service center run by lab, and self-collection isn't the typical norm. So if a lab wants to engage in this type of business model, it has to conduct a validation study to confirm that self-collection, is it going to affect specimen integrity or the accuracy of the testing results?

	Now for example, the instructions, it has to be a test kit that's easy to use. The instructions have to be clear. The lab has to be sure that the self-collection kit properly preserves the specimen, which for example, can be degraded by extreme temperatures. So before the lab embarks in this process, it goes through this validation study to be sure that self-collection isn't going to diminish the accuracy, or the sensitivity, or the the quality of the testing. And one thing I would mention that for labs, it is vitally important that if a lab does decide to go through this process, it does need to keep the records of its validation study. You'd be surprised how many times I advised labs who haven't kept the proper records, and then find themselves sort of in harm's way at inspection time.

	Now, I also wanted to mention that the self-collection kit itself, as opposed to the diagnostic test kit, also has to be cleared or approved. If it's what is called the class two or class three medical device, it has to be cleared or approved for home use by its manufacturer, or it has to be exempt, which is a class one medical device, and the manufacturer or assembler of the kit has to be registered with the FDA. So as an alternative, FDA would also allow the lab to seek clearance or approval for the assay itself, as well as the collection kit.

	So there are state regulations that apply as well. Some states issue a state license along with the CLIA certificate. And therefore, states sometimes have their own separate regulatory scheme that's separate from CLIA. Laboratories located in states that have such a scheme, they of course, have to have the license for the state where they're located. But there were also five states that require out of state licensure for labs that want to test specimens, including those that are self-collected and received from their respective states.

	Now of those states, I wanted to mention in closing, New York in particular, it's a state that has standards that are actually more stringent than CLIA. And it's the only one as a result, that requires an inspection before licensure, and it does its own independent validation of assays. And getting a New York permit is a long, difficult process. And as a result, there are some labs that you may see that don't take New York testing at all. And that as a result, may or may not take specimens from New York patients for self-collection.

	And then finally, I did want to note in closing that a handful of states have laws that require a physician order. In other words, a patient can't order their own test. And that's why most labs who have this home collection business model, will require a physician consultation and physician order. And so with that, I'm going to turn it over to Adam.

Slide Description:	Minors’ Consent and Confidentiality

	Adam Sonfield

www.guttmacher.org

	Guttmacher Institute logo

Adam Sonfield:	Thank you, Karen. Hi, everyone. I'm Adam Sonfield, with the Guttmacher Institute. Naomi, you want to move my slide? Thank you. Not much of a slide. I just wanted to have an intro slide there. In case you're not familiar with Guttmacher, we are a think tank that's devoted to sexual and reproductive health and rights. For today, I'm going to talk about regulatory and practical issues around minors' consent and confidentiality, and provide some initial thoughts about how they might intersect with remote health.

Slide Description:	

1. Minors’ consent and confidentiality matter, especially for sensitive services like STI testing and treatment

2. Consent and confidentiality are not always linked in policy or practice

3. Consent and confidentiality are governed by a complex mesh of laws, regulations, program rules and routine practices

4. Remote health adds additional layers of complexity, opportunity and challenge

Adam Sonfield:	And I have four main points you'll hear today, which are on the slides. So I won't walk through them individually until I get to them. In terms of that first point, the minors' consent and confidentiality matter, I don't want to belabor the point here for an audience of people who work in STIs. I think most of you are aware of the importance of confidentiality. We know it's an issue for minors, it's an issue for adult children on their parents' plans, or spouses concerned about intimate partner violence and for others as well.

	Most of the major medical groups who support minors' consent and confidentiality, particularly for sensitive services like STI testing and treatment, because they recognize the harm that might otherwise result in terms of continuing risk behavior without getting information care they might need to protect themselves, not to mention the potential for abuse and neglect in certain circumstances from parents or from partners. And there is a good deal of data to back up those concerns. We know that young people are less likely than older people to use their insurance for services like STI care. And they're more likely to cite confidentiality concerns specifically as the reason. We know that most young people do talk to their parents before they receive sexual health care. But of those who don't, most say they'd forego care and their parents had to be taught.

	So all those leads to consent and confidentiality being important, but as I want to make it clear in my second point, they're not the same thing. And while we may think of them as being linked to in practice, they're not necessarily always linked under the law under specific policies. The supreme court actually affirmed back in 1977, that minors have a constitutional right to privacy just like adults. That was a case involving contraception. It hasn't always been extended to all healthcare services, particularly not to abortion where most states do have parental involvement requirements. But when it comes to STI testing and care, 50 states, all 50 states have laws affirming minors' right to consent to their own STI testing and treatment. Some of those states have minimum age requirements, never below 12 in those cases. Not every state explicitly includes HIV because some of those laws were written before HIV was even a thing.

	But I think the most notable piece of some of those laws for this discussion is that they don't necessarily extend to confidentiality. In fact, 18 of those 50 states explicitly allow physicians to inform a minor's parents that they're seeking or receiving STI services. And even putting aside what the law might say, confidentiality might get violated in other ways, by routine insurance practices, like explanation of benefit forms or online patient portals, or just careless practices at a provider office or the pharmacy. The receptionist greeting a parent and saying, "Oh, I just saw your daughter here the other day." And particularly in a smaller town, I know a lot of people can be really concerned with those sort of confidentiality violations.

	My third main point here is just that it's a complicated regulatory environment. There's no comprehensive national standard for minors' consent and confidentiality when it comes to healthcare. As I said, there are laws in every state. They vary in lots of different ways. They vary based on type of care. Contraception treated differently from STI testing and treatment, treated differently from abortion, treated differently from substance abuse treatment or pregnancy care. Yeah. They vary based on the characteristics of the patients, not just their age, but also things like marital status and whether they're a parent. It varies depending on the source of the care itself and the funding for that care. So just as an example, Utah and Texas actually require parental consent for contraception in state funded programs, and they're the only states that do that.

	On the flip side, you have something like the Title X, National Family Planning Program, which has specific confidentiality protections from minors and prohibits parental consent. And that applies nationwide to any service funded by Title X. So it can vary quite a bit based on all those different factors. And the confidentiality laws vary even to a greater extent in a lot of ways. Some states do have laws specifically tackling the issue of confidentiality and explanation of benefits forms, but a lot of states don't. And beyond the actual policy, I mentioned before, providers' actions and decisions matter a lot. There's a lot of discretion given to individual providers about whether when to involve parents. And yeah, so those insurance practices I mentioned, and other practical practices as well, it makes for a difficult environment for providers to even keep track of what the law and the policy is in their own state and in their own practice. And that's one of the big recommendations from provider groups, is to make sure you're keep to date on those policies in your state.

	Remote health adds to that complexity. I think actually, there are some issues about which of the laws apply when you're treating people across state lines. How much of the laws in the state that providers are located matter versus the laws in the state where the patient's [inaudible 00:29:02] is located? I think the pandemic has brought home some additional issues specifically. You think about adolescent stuck at home with their parents throughout the entire pandemic. And it can be pretty hard to have a private video conference or a phone call with your healthcare provider in that environment.

	And it could also be really difficult to receive or bail out on remote testing kits, or to receive condoms in the mail or other drugs and devices. It may be hard to use an alternative mailing address, which is a standard practice for a lot of healthcare providers. When they want to provide confidential care, is to mail out information to a different mailing address than their home address. That might not be possible in the middle of the pandemic. I think yesterday, we also heard about some new technology that raises some interesting privacy concerns. We heard yesterday about technologies that track patient's health and behavior, and store them on a phone, or transmit that information to providers. And I think there's some important questions to consider about whether parents or partners will be able to gain access to the info, and either whether they have a right to legally, or even just through other means.

	I mean, you think about all the different tools that people have to snoop on each other's phones and parents have apps specifically designed for them to keep track of their other children's behavior online. They may have restrictions on downloading apps. They might need your parents' permission to even download one of these tools. We have to think about data use records and all that. So there are all sorts of ways I think, in which you may have some privacy issues with this new technology that may be a particular concern for adolescents.

	And on the flip side, we certainly have reason to think that remote healthcare holds a lot of premise when it comes to confidentiality for minors. We talked yesterday about asynchronous communication and clearly, texting and other forms of asynchronous communication can be wonderful for confidentiality. And yeah, there're some text messaging apps, for instance, that have that built into them. We have auto deleting messages and end-to-end encryption. And that's saying that a lot of minors really care about already and are often very savvy about, which I think is true more generally for the technologies that we're talking about. In the United States at least, most minors are very much at home online and on their cell phones. And that makes some of these new technological innovations that gives them strong potential, for minors in particular.

	I'm going to stop there. Right now, we're over time already on our session. I hope this provides some food for thought as we consider remote health and how consent and confidentiality might fit into the big picture. So thanks to everyone and thanks to Naomi for organizing all this for us.

Naomi Seiler:	Wonderful. Thank you all so much. And I hope folks can follow up with your respective websites, which I believe, CDC has some written materials, or we can provide with followup for more information. The next panel organized by Natalie Crawford, will look at the role of pharmacies and pharmacists.

There is a period of silence here while the slide is being pulled up to be shared.

Title Slide:	Discussion Session: Role of Pharmacies

	Organizer: Natalie Crawford, PhD

	Discussants:Crystal Lewis, PhDGlen Pietrandoni, RPh, AAHIVECAPT Paul J. Weidle, PharmD, MPD

Natalie Crawford:	Thank you so much for that introduction, Naomi. So today, I just want to thank you and all the organizers for this meeting. I am happy to be the organizer for the role of pharmacies. My name is Natalie Crawford. I'm an assistant professor in Behavioral, Social and Health Education Sciences, and the associate director of the Prevention Science Core for Emory University's Center for AIDS and Research. I'm very excited to be part of this meeting on rural health. And I'm going to start by introducing an incredibly accomplished panel of speakers. First, we have Dr. Crystal Lewis. She's an associate professor in Laura M. Tisch Scholar for Racial Equity and Mental Health at NYU's Grossman School of Medicine, Department of Psychiatry, and division head of Social Solutions and Services Research at the Nathan Kline Institute for Psychiatric Research. Dr. Lewis' work has transformed the way pharmacies provide services for people who inject drugs in New York City. She provided the early evidence space for safe provision of syringes over-the-counter and other HIV prevention services, including HIV testing and linkage to care. She has trained hundreds of pharmacists...

	Hundreds of pharmacies from dozens of... Hundreds of pharmacists, and dozens of pharmacies on how to engage in compassionate treatment of people who inject drugs that is steeped in harm reduction principles. I'm very lucky to have had the opportunity to receive training and mentorship from Dr. Lewis and to hear her share how we can continue to push the envelope in research to incorporate pharmacies in HIV and STI prevention and treatment. Next we have Glen Piatrandoni, Glen has over 30 years experience as a pharmacist and is a subject matter expert for patients, providers, payers, pharmacists, and manufacturers for Avita, which is a national HIV PrEP pharmacy services provider. Glen is a lifelong advocate for people living with and at risk for HIV. I was introduced to Glen first while pitching an idea for integrating PrEP screening into pharmacies, which is the work that I do.

	And from the very moment that I met Glen, I could literally feel his passion for moving the needle to be a resource and partner for communities affected by HIV. Not only that, Glen intimately understands the policy level nuances on the national and pharmacy levels that impact how we do this important work. Last but not least, Paul Weidle is in the office of the Director of the Division of HIV AIDS Prevention at the CDC. He is currently Deputy for Program Operations, supporting the division's efforts on ending the HIV epidemic initiative. Dr. Weidle has an extensive career in increasing HIV prevention in community pharmacies, specifically he's led projects to implement HIV testing at community pharmacies, establish a patient-center HIV care model, using community pharmacies and using medical and prescription claims data to improve uptake of and adherence to HIV antiretroviral therapy.

	I'm very fortunate to have had the unique privilege of working with each of the panelists and believe they will provide us with a unique and exciting perspective on the current and forthcoming issues related to pharmacies in HIV and STI prevention and treatment. I want to share a slide with you that will hopefully give us sort of a bird's eye view of a lot of the issues that we will be discussing today.

Slide Description:	Role of Pharmacies Chart

	Shown are 4 levels of influence: Policy, Community, Pharmacy, and Individual and underneath each level there are challenges. Policy level influence includes: national policy, local policy, and state board of pharmacy. Community level influence includes: healthcare access, HIV stigma, and HIV burden. At the pharmacy level, there are is a circular process that shows the following influences: Tasks (HIV treatment and prevention activities), Personnel (Pharmacists and technicians), Pharmacy Environment (Business flow and internal — private space), and Pharmacy Organization (Corporate and internal policy). Individual level influence includes: risk behavior; the need for PrEP/HIV treatment; pharmacy HIV prevention/treatment services; update and adherence; and reduced HIV transmission.

	Source: Emory University Center for AIDS Research

Natalie Crawford:	So while pharmacies provide a strong existing infrastructure that is supportive of populations with reduced healthcare access, there are some important factors across multiple levels of influence from the policy to the community pharmacy and individual levels that should remain in view. This figure is not exhaustive of all of the levels of influence, but it is my hope that we will discuss some of the specific challenges across each level, from the role that Boards of Pharmacy play with respect to the adoption of HIV prevention and treatment services, to how community health care access and stigma may heighten the need for pharmacy services. And importantly, how multi-level influences even within the pharmacy level impact our ability to successfully expand services to pharmacies. For example, in the first line of entry under the pharmacy level.

	So improving HIV prevention and treatment access is going to rely on evidence-based implementable services, services that pharmacists and technicians are adequately trained to provide that are supported by distal organizational structures that enable the pharmacy's work environment to integrate the services, considering existing time constraints and compensation models. These factors are particularly relevant for community pharmacies and those in rural areas where pharmacy workflows may already be overloaded due to high disease burden in the community. Identifying pharmacy level organizational practices that make individual patients accept pharmacy based HIV and STI prevention and treatment services are pertinent for our ultimate goal, which is to reduce HIV transmission on the individual level and in the HIV epidemic.

	So without further ado, I want to pose a overarching question to all of my panelists. And I would like for you to spend a few minutes answering this question from your specific perspectives. This first question is, from your perspective, what are the multi-level barriers to implementing pharmacy-based services and what have you seen work in pharmacies and what has not?

Glen Pietrandoni:	So maybe I could start, this is a topic that is near and dear to my heart. On a single pharmacy level there's a lot of things a pharmacy or pharmacist can do, training their staff, preparing for the services that they're going to offer. But in every case it does need to be a business decision, you need to be reimbursed for time, you need to be able to be trained and proficient in whatever service you're providing. And we do have some examples of where this has been done in individual pharmacies around the country, but in order to scale it, there is a lot more complexity in understanding how do patients even find out about the service, which location might be available, which pharmacist needs to be on duty at that particular time and even to the extent of a patient walking into a pharmacy, asking for the service could be a challenge, right? If there's a customer standing around and you want an HIV test, for example, that's a challenge right in itself, right?

	And then the physical plant in a pharmacy could also become a problem where there may not be a private space, not just visually private, but also from a sound perspective, where can you go to have a conversation of a personal nature and not all pharmacies have that space? So I'm going to just stop there because my list actually goes on a little bit longer, not to be negative about the idea it just needs, I think to be very thoughtful in the way it's scaled. Not that it can't be done, but it needs to be scaled properly.

Dr. Crystal Lewis:	Thank you for that Glen, these are a lot of structural features that you've mentioned and Natalie has mentioned them nicely in her overview on the current slide, but I'm going to take this opportunity to talk about a recent experience that I've had since, during the pandemic and working with pharmacists and looking at their response to COVID testing, to COVID vaccinations and we can learn a lot from what we've seen recently.

	I understand New York is very different, but there's features about New York that aren't so different, because while New York City is, is New York City, there isn't any other place probably in the country that look like New York City in terms of the complexities and the density of population. But outside of New York looks very much like the rest of the state. And I would like to propose that we focus on independent community pharmacies and these pharmacists are finally reaching mainstream and people are starting to talk about them because they're so nimble and they can make a lot of these structural changes like tomorrow, today, whenever and we do have a critical mass of committed public health minded community pharmacists and a lot of times they're in areas that our big corporate chains are not located. And it's no surprise to anyone that corporations are interested in their bottom line and getting paid.

	And we saw that with the pandemic, although they're doing vaccinations in the community, they're requiring people for the most part to go online and have a lot of access, and they're not leaving their pharmacy. I've worked with two community pharmacists who vaccinated over 5,000 people in 30 days and that's leaving the pharmacies and going out into the community and that's because they can. So I want to... And when you see that type of nimbleness and flexibility, then you can start to see the bandwidth and the expanded role of pharmacies to be able to do a lot of these things.

	And as Natalie indicated, I started in harm reduction and coupling services, Natalie was a big part of that and led these efforts and seeing how much we can do in pharmacies. And it really just takes... And you don't even need a lot, we're not talking about having 70% of pharmacists who agree to do this. There are so many pharmacists, if just 30% of them, that's like 20, 30 more spaces that can provide services to high risk communities.

	So I'm going to stop there. That's my little soap box, but I really would like for that to be something that is out in the forefront of everyone's mind, and there are a lot of community pharmacists out there, which is something else that people didn't realize. We don't need the chains, there is a strong association of independence, a lot of minority owned businesses and I think this could be very impactful.

Paul Weidle:	Yeah thanks guys, I guess, just to follow on that, I think one of the things that's important is to give the pharmacist the structure within which to work, so like from a policy level or from a jurisdictional level. A great example of that is non-prescription syringe sales, so any one pharmacist can sell syringes today in their store, but ideally they'd have some sort of program or support to work within. Whether that's through their store locally or through their network of pharmacies, or are ideally supported by the health department with, I call them the obligate pamphlets and referral materials for people who come in. So otherwise you're just reacting to whoever walks up to the counter that day, it's better to have a process in place.

	Having said that, I think one of the other things in terms of, I guess a big structural item is what Natalie mentioned before that we've been working on here at CDC what we call Data-to-Care Rx, it's using claims data, medical claims data and pharmacy claims data to identify people at a macro level who have HIV, who are not taking their medicines. They've either never taken the HIV medicines or stopped and to put interventions in place to identify those people and follow up with them.

	So some of that can be at the pharmacist level, but to be honest, once the person doesn't fill their prescription and is gone, it's hard for the pharmacist. There's a reason that the person didn't come in, so the pharmacist can't always necessarily follow up at one month, two month, three month, four, to follow the person, but at a macro level, the insurer or the network plan has a responsibility to make sure that their people with HIV are taking medicine. So they can be looking at the claims data and come up with interventions, either through the pharmacy, or through the clinic, or through the health department, with DIS and Dual Partner Services interventions. So let me stop there and see if-

Natalie Crawford:	Thank you so much. I have another question that I would like to pose to each of you, you are all bringing up really important points about infrastructure and support. Can you tell me about in your experience, what types of training have you seen and what is additionally needed for pharmacy staff in terms of patient education on the HIV prevention and treatment contingents?

Glen Pietrandoni:	So maybe I could start then again. I'm thinking in terms of H1N1, I think Dr. [Chaudry 00:45:38] brought it up, it wasn't that long ago, 2009, 2010, that pharmacists were trained for the first time to be providing immunizations for example. And it was because of H1N1, that now it's a requirement in every pharmacy school and every pharmacy that is possibly part of a chain, as a requirement of being hired, the pharmacists need to be able to administer vaccines. And so it took a while, but it is part of our culture and in our professional scope of practice now to give vaccinations. So I think the same thing needs to happen in HIV prevention and administration of medications possibly for HIV prevention, that needs to be adopted at the pharmacy school level, through to the State Board of Pharmacy and all the way to the chains and the independent partner let's say, for that education with possibly [inaudible 00:46:33] or possibly other organizations that are more local to meet that need of that specific community.

Dr. Crystal Lewis:	Thank you Glenn. That was spot on and I didn't actually think about curriculum and where we should begin when we think about how far we can expand pharmacy practice. And it would be really nice if we could have a public health track. We do have one at Touro College of Pharmacy where it is a little different, there is space for interns to go and get experience in the community. We had interns in our research for the most part around the clock, we get three rotating in and out and they liked it. And I can honestly say in medicine in general, we're finding that a lot of young people want to do more and they want to go outside the bounds of traditional training, whether it's pharmacy practice or medicine, because they see the need to do more in order to have impact.

	I recently, again, because these were community pharmacists, I actually trained the pharmacy staff in doing rapid HIV and Hep C rapid tests prior to this in our work in doing on-site HIV testing, the research staff came in and we co-located, so there's co-location that can happen. But what would be really sustainable is if pharmacy staff had this training themselves. So again, I was able to train the staff, they were very excited about doing it. If you're interested in bottom line, they see this as away in connecting with community and creating an increase in the patient load for that particular pharmacist. If their people are positive, they fill their medication there. So I think it's not farfetched, I think the interest is there and I think we should try to do more to show that this is possible.

Paul Weidle:	Yeah. Just add with CDC, we did develop a continuing education program for pharmacists for HIV testing in community pharmacies and on the original project we worked on back a number of years ago, Glen was actually part of that, he was a big help with all of that. So we do have some materials like that. I think in general though, I think it's important not to expect every pharmacist to be able to do everything in HIV prevention, because functionally it's just too many people and they're too busy, they have too many other things to do.

	I think one really neat example recently is in Iowa, they have a TelePrEP program that's managed by a pharmacist at the School of Pharmacy, working with the Department of Health. And they're working over many county area where, you know there are pharmacies in all these counties and such, but you can't expect that because it's a sparsely populated area and there aren't that many people with HIV or that many people at risk compared to a big city, it's hard to expect every pharmacist to now become the expert PrEP guy who takes care of his one patient that shows up at the pharmacy. It makes sense to do it through a collaborative practice agreement like they're doing there, where people get referred to the TelePrEP program.

	And there are a lot of TelePrEP programs now that are run by nurses or physicians, of course, but I think it's a good example. Pharmacists can do TelePrEP under a collaborative practice agreement with the physician. And the training for that it's just more concentrated because you're training a few people to run a program and not expecting every pharmacist in every pharmacy, in rural Iowa to be the PrEP expert, but maybe I'll stop there.

Natalie Crawford:	Can anyone speak to the role of the pharmacy technician? I know we talk a lot about training pharmacists specifically, but has anyone in their work seen pharmacy technicians being able to provide a patient education or specifically HIV prevention services in pharmacies?

Glen Pietrandoni:	I [crosstalk 00:50:54] Oh, go ahead, Crystal.

Dr. Crystal Lewis:	No, no, you've been, let's keep the order. That was a good order.

Glen Pietrandoni:	Okay. I can't say specifically that I have, but in the case of, again immunizations, many state Boards of Pharmacy now are allowing technicians to provide immunizations and they've expanded their scope of the practice as well. And that goes again to what maybe [Karen 00:51:19] and Dr. Chaudry were saying about how each state has their own regulatory bodies that control these things, but certainly there's a role for technicians in every piece of this and the training is going to be the key there I think.

Dr. Crystal Lewis:	Yeah. And that's what I... And the training that we just conducted recently, we actually trained the clerks and the technicians in HIV testing and not the pharmacist, but it was optional for the pharmacist, he could do it if he wanted to, but at that time he was busy doing COVID testing so it wasn't feasible. But I think it is something that technicians and clerks in particular, pharmacy clerks who, they like additional training, they like building their skillset, so I think that's an untapped space.

	Now the problem again with... The problem with corporate change, for example Duane Reade and Natalie and I were writing a grant just recently and they have a very strong, hard rule against their staff doing anything outside of what they've been hired to do, which is traditional pharmacy practice type duties, I guess I'll call them. But they loved having co-located services, loved it, loved it, loved it, but they did not want their staff doing it. But again, the community pharmacist has no problem within this space.

	And just it's... Paul, I hear you about, we can't have this expectation for all pharmacists to do this sort of thing. But when we first started evaluating ESAP, the Expanded Syringe Access Program in New York, it was voluntary. We had no idea how many pharmacists would be willing to participate in this, but about 30 to 40% were on board and felt that this was something that they wanted to do. Now it doesn't sound like a high percentage, but when you have a thousand pharmacies, 30 to 40%, it's a lot. So if we had... It's not for everyone, not everybody is willing to do it, I currently have a study in the field now evaluating pharmacists upstate in some rural and small metro areas, as well as New York City and seeing what their bandwidth is like, and if this is something that they would be interested in. Not just around HIV testing, but the problems around the [inaudible 00:53:45] distribution.

	I mean, there's a lot of public health policies that we've now opened up, obviously COVID testing and vaccination that we really can start to think how they're managing all this and what they're willing to do. And some are all for it, they want to do it, maybe it's all truism. But I can say the ones who are most willing to go out of their way and put the time into this additional training and these additional services are the independents and not the corporate chains, which is unfortunate, but it's the reality. And I'll stop there because it's almost time. I don't know if you have another question [crosstalk 00:54:24].

Glen Pietrandoni:	If I could just add one comment to that though, if we could, as a profession get provider status so that we could actually bill for some of those services that will solve all of your concerns, because the corporate will be there in line with everybody else. But in order to do a lot of the things that you want to do at scale, it needs provider status.

Natalie Crawford:	I do have one last [crosstalk 00:54:49] Oh, I'm sorry. Go ahead Paul, please.

Paul Weidle:	I was going to just say to the questions about technicians and I think that's where technicians come in because they are a lot cheaper than a pharmacist. So you want the technician to be doing work that supports premises if it's an HIV testing program, maybe setting up the appointments or scheduling, greeting the person when they first come in and the pharmacist would do the test and get the result. But you want... You use the tech for the other times so the pharmacist is not spending as much time doing all that. But, go ahead Natalie.

Natalie Crawford:	In our last few minutes, I just wanted to specifically direct a question to Glen who is a Board of Pharmacy member, because I think that's also a big part of this discussion. I wanted to see if you could shed some light on the role of Boards of Pharmacy in this discussion and how can we get Boards of Pharmacies to help and sort of, what has been their role historically in this?

Glen Pietrandoni:	Yeah, so I'm on the Board of Pharmacy in the State of Illinois and also as part of the National Board of Pharmacy group. We just had our annual meeting a few weeks ago, but I think it's going to take the federal level legislation to actually mandate some of these things like they did with the PrEP bill and allowing pharmacists to do COVID testing and COVID vaccinations. It was up until that point that we were not able to do that in every state and if we're going to try to go across 50 States again like Karen and Dr. Chaudry were talking about, if we have to go state by state, by state to try to get some national scope of practice change, it's going to be crazy.

	And I know in Illinois specifically, we get a lot of pushback from the medical societies that do not want to see pharmacists have expanded scope of practice. So I would love to see HHS or whoever it is at the national level, to mandate requirements like this for pharmacists and State Boards of Pharmacy. Every State Board of Pharmacy is also set up differently, in Illinois we're more of an advisory board, but the legislature actually makes laws and other states have a different setup, so every single state is going to be different.

Natalie Crawford:	Okay. Thank you guys so much. Does anyone have any final thoughts that you would like to share with the group?

Dr. Crystal Lewis:	Nat I'd just like to say one thing, I was just thinking about reimbursement and this kind of relates to the pharmacy board as well because they're an advocacy group, right, you're lobbying. And what is also needed is that we have equity in how these services are reimbursed and there is no end and I'm basically talking about differences in insurance companies and how they reimburse for different services. That's another thing we saw with COVID vaccinations on what reimbursement you get based on the insurance you have, and that played a role in who had access and how far pharmacists were willing to go to provide this service. So it can't be something where Medicaid reimbursed at a lower rate and private insurance at a higher rate and this sort of thing. And I'm no expert in that sort of thing, but I'm learning about it and there's a lot of inequity in terms of insurance, in terms of whether you're corporate or you're independent and I think the boards can really play a strong role there.

Glen Pietrandoni:	Yeah just to add on that is the insurance company owned pharmacies, that mandate you go to those pharmacies carving up the independents, so these are all issues that are very critical.

Dr. Crystal Lewis:	Exactly.

Natalie Crawford:	And we are lucky because our next session is on issues around reimbursement, which will be led by Jeffrey Crowley, so it's a perfect segue. Thank you so much to the panelists, I really appreciate this and thank you for shedding light for all of our guests. Jeffrey.

Title Slide:	Panel Session: Issues Around Reimbursement

	Organizer: Jeffrey S. Crowley, MPH

	Panelists:Marwan Haddad, MD, MPH, AAHIVSJulia Hidaldo, ScD, MSW, MPHJean McGuire, PhD, MSPH

Jeffrey Crowley:	Great. Thank you very much. Let me try to share my screen.

	So hello everybody as was said, I'm Jeffrey Crowley with the O'Neill Institute for National and Global Health Law at Georgetown Law. I'm happy to moderate this panel of discussion today on issues around reimbursement. I want to say up front, I don't think any of us think that we're coming to you presenting the answers as much as hopefully starting a conversation. I hope that we will have time to have a discussion. So I encourage you to try to send any questions to the chat, but we'll jump right in.

	I first want to introduce our three excellent panelists. First we'll hear from Dr. Julia Hidaldo, who is the Chief Executive Officer of Positive Outcomes Inc, which focuses on communicable disease program design, financing, evaluation and implementation research for our local state and federal government agencies, insurers and foundations. She has worked for three decades in designing HIV, STI, and HPV screening treatment and therapeutics. She also was a long time research professor at George Washington University.

	Then we'll hear from Dr. Marwan Haddad, who's currently the Medical Director of the Center for Key Populations at Community Health Center Inc in Middletown, Connecticut, which is one of the largest federally qualified health centers in the nation. The Center for Key Populations is the first center of its kind focused on engaging populations who traditionally experience barriers to comprehensive and respectful care, secondary to stigma discrimination.

	Third, we'll hear from Dr. Jean McGuire, who actually has over 30 years of senior experience on local, state and national public health and disability policy and program development, management, financing, research and evaluation. She's, really has a broad perspective on the health system. She has directed local disability and long-term care programs, she's worked as a health care lobbyist in Washington, she has led policy organizations and coalitions in HIV/AIDS and disability and chaired or participated in many federal agency review processes. She's also served as the Massachusetts Assistant Commissioner for Public Health for five years. And most recently she spent five years as the Assistant Secretary of the Executive Office of Health and Human Services in Massachusetts.

	So we're very excited to hear from all three of them today. So now I'd just like to quickly give you the framework. And I think the most important point of this slide is to say that there are lots of things we can do in a crisis and COVID-19 certainly was a crisis. So I think our collective challenge is really, how do we move from a crisis response to use telehealth as an integrated part of our model of care. Now there's some key considerations, the clinic billing capacity, making sure clinics have sufficient income, the status and use of their electronic medical record.

Slide Description:	Telehealth Reimbursement Models

	Considerations

· Clinic billing capacity

· Clinic income

· EMR/Data Management

· Parity (for which services?)

· Reimbursement for variable patient supports/communications

· Equipment needs/HIPAA-compliant systems

· Staffing needs/patterns

	Ideal Outcomes

· Clinic solvency/stability

· Improved patient choice/satisfaction/retention

· Greater provider flexibility/satisfaction

· Increased flexibility to respond to changing circumstances/ variable demand for services

· Less stress for everyone

	Crisis response moving toward Integrated part of the model of care

Jeffrey Crowley:	There's been a big debate with telehealth regarding parity, for which services, there's issues around reimbursement for variable patient supports and communications, I'm thinking here of asynchronous services, where as providers spend more and more time, for example responding to texts and messages from patients. There's issues around equipment needs and HIPAA compliance systems and then issues around staffing needs and patterns. But I think there's some real clear potential benefits or ideal outcomes and that would be that clinics remain solvent and stable. They improve patient choice, satisfaction, retention and care. They give providers greater flexibility and satisfaction. They give clinics and providers greater capacity of flexibility to respond to changing circumstances and really produce less stress for everyone. So with that, let's turn to Dr. Hidaldo, Julia. And if you're speaking, we can't... Might be muted.

Dr. Julia Hidaldo:	How's that?

Jeffrey Crowley:	That is great. Thank you.

Dr. Julia Hidaldo:	Great. Hi. So you get to stare at the slide and I'm going to chat with you for a few minutes. I was able to spend time yesterday listening to the session and to this morning's session. And as Jeff has said, I spent many, many years thinking about how to pay for stuff in a variety of different levels, in different settings, with different providers and so on. So I have a whole list of things that I would suggest to you that you could do to sort of move over to implementation of the model and paradigm of telehealth in a payment model across the country. But I'm not going to do that because I only have five minutes and only I can do so much.

	But I did want to share with you a case example of a community that just went through a year of COVID, because we learned a lot. This is a large metropolitan area, it has one of the highest HIV population adjusted epidemics in the country, it is in a conservative state, but that has expanded Medicaid for folks with HIV in their own managed care organizations. So there's lots of different innovation as well as drawbacks. In the middle of March, the state shut down and almost immediately the Ryan White Program alerted all their providers that they could do certain things, so they could see certain patients, they could do it all by phone and they could bill. So it all sounded great and as their evaluator, I was able to go back and look at the last year and their experience, as well as the experience of their providers and clients and compare that experience with the year before.

	Some of the unintended consequences, almost a third of the clients that were served in 2019 were not in care in 2020. These were all folks that could at least get services through a Ryan White Program and many of them had health insurance. We don't know if they moved, we don't know if they died, we know very little. So in our lost to care project we're actually trying to track them down.

	I also look very specifically at screening for STI's and found concerningly, not only did screening drop considerably during the year of COVID, but it wasn't that great to begin with. This is a jurisdiction with a raging syphilis epidemic that has gone unabated and screening rates had plummeted during 2020. And so in order to pull back and to screen those folks, about 3000 people would need to have an STI panel right off the bat. That's 3000 folks would need to get a test kit, go to a lab, go to the doctor's office in a setting where many of those clinics were at full capacity before COVID, physical capacity and staffing.

	Also, I'm very interested in HPV as Jeff mentioned. And I looked at the HPV rates, they were not great, even though this is a population with increasingly a very large number of "elderly" HIV patients. And in order to bring them up to the screening rate that's advised by the feds, almost 5,000 people would have to be screened for HPV, which says to me, as I'm trying to think about how to sell this to payers, all this being telehealth and other mechanisms to reduce the burden on the physical capacity and staff capacity of clinics, a considerable amount of telehealth or other similar models would have to be done. Now, I do just want to mention that in those screening rates, almost all those patients got a CD4 count at least once last year. So they were at a clinic, they were at a [inaudible 01:07:13] and so on.

	I also just wanted to highlight in terms of payments, some of the things that played out that were unintended consequences, both good or bad, I mentioned that many folks were lost to care. We also found that many people moved into that jurisdiction with HIV positive and treatment histories and they were not eligible for Ryan White services theoretically, because they didn't reside in that jurisdiction. But the clinics had to go ahead and provide them services anyway, which raised a lot of issues about reimbursement. Also some of the clinics could not open for months. They were in large institutions that had a very slow issue about getting staff back.

... They had a very slow issue about getting staff back. Many of the staff were infected and so, the number of staff that were available and the number of folks that could actually do telehealth had plummeted. And so, the revenue that they gained over the last year was considerably lower. On the pharmacy side, yes, they were able to get their medications, but they didn't want to have to come to the clinic's pharmacy, they wanted to go to a retail pharmacy down the street. There's that plant pharmacy, their, not only 340B money, but also the funds that they receive for filling prescriptions had plummeted as well. Sadly, even though these are fairly experienced clinics, many of them were totally unaware how to bill for telehealth. The Ryan White program gave them the coding set, but most of them did not actually bill for their telehealth visits for a variety of different reasons, including the fact that their staff were either not in clinic, because they were in quarantine or they didn't know how to bill and they hadn't been trained and supervised adequately.

	Other issues that came up, on the plus side, is that in the past many clients were reluctant to participate in mental health groups or other mental health services. And so, the mental health providers went entirely to telehealth and the actual kept appointment rates and participation in therapeutic groups actually escalated considerably. Some of the other things that I just wanted to mention is that in thinking about this whole paradigm of moving to telehealth, many of the sort of traditional health department services in a clinical setting, even though they may also be Ryan White, have very inadequate capacity to do billing, poorly experienced and unaware of some of the covered things.

	My favorite example is condoms. The Medicaid program through family planning can issue prescriptions for a 30 day supply of condoms and I pick on that is almost never happening, even though it's a very traditionally billed service and so on. So, I'm hoping that through today's discussion and then hopefully follow up, if we're really serious about paying for all this, we have a concern conversation about what is billable, why it's billable and what can be made billable? Thanks.

Jeffrey Crowley:	Great, thank you so much, Julia. Now we'll turn to you Marwan.

Marwan Haddad:	Thank so much, Jeff and Julia. Thank you for inviting me to be part of this panel. So, I'm here to discuss our experience of standing up telehealth nearly overnight about now, my God, a year and three months ago, when the COVID pandemic obviously hit and at this large federally qualified community health center in Connecticut. So for context, [inaudible 01:11:22] CHC, we have 15 health center sites across the state of Connecticut. We've got over 200 clinical touch points throughout the state, including school-based health clinics, the homeless shelters and mobile dental. We serve over a 100,000, well now, 140,000 patients or so. And so, as we all witnessed, this COVID pandemic stimulated and accelerated the adoption of telehealth that would have otherwise taken many, many, many years to accomplish, so I think in many ways, that's a great thing.

	So today, I'm just going to talk a little bit about what allowed this to happen for us and I will touch briefly about some of the challenges and then maybe summarize succinctly a few thoughts about the way forward. So, I think first and most importantly, I think, because the federal and the state responses were immediate as we shut down as a nation, for instance, the issuing of the federal and the state based emergency authorizations that allowed for reimbursement of telehealth visits for Medicaid and for some of the commercial insurance populations, that really allowed us to make that incredible pivot to telehealth, which for us at the beginning, we almost went exclusively to telehealth. We went 95% telehealth at the start. And so, the key to the success of this huge pivot for us really has been that authorization of the reimbursement for both, audio only, so for phone, as well as for the tele video visits. And I think that is a crucial point to make.

	And this was definitely very important for my own patients. Many of my patients struggle with substance use or living with HIV or are homeless and they really had a very hard time struggling to get onto video, if at all. And so, many of my patients still, to this day, I still connect with them only by phone. And so, having that authorization for both phone and video, really, I think, also prevented the bias against those who do not have the technical capacity, either because they don't have broadband or can't afford smartphones or computers, but also, don't have the comfort level of using the technology as well. And the other key point of this, as well as for success with the reimbursements that we were allowed, were equivalent to the amount for in-person visits. And so, that was both for phone and video and that sort of extended to the whole care team as well, so it wasn't only just medical, but it was also our nursing, our behavioral health and some of the ancillary services as well for nutrition, diabetes educators and podiatrists.

	And the other great thing now, moving forward when we're looking ahead, is that we have to applaud the State of Connecticut as well as our governor, because they just extended the emergency authorization of full payment for Medicaid telehealth visits, that's consistent with in-person visits for two full years. And that really is acknowledging its importance, the telehealth importance during the pandemic, but also with the eye of moving forward, of the importance of telehealth in healthcare. So, what have been some of the challenges to roll this out? I think I was really focusing more on the reimbursement sort of part of it, and we can talk a little bit more about other aspects of it, but currently we have to code the billing of telehealth differently than coding for in-person visits, so that had to create this whole new training process and roll out process.

	And then, within telehealth, you have to bill differently for phone versus video. And so, for phone visits, they're coded and billed based on time, right? So how much time did you spend with a patient? And so, to be eligible for reimbursement, a phone visit has to be at least 11 minutes. So we opted on the advice of our general counsel to have providers write down both start and end times. And this time does not include, by the way, the time that medical assistants work with our patients and doing all that sort of work that they do and the preventative care work that they do with them. And then you have to bill, if it's 11 to 20 minutes to one sort of code, if it's more than 21 minutes, it's a different code. And so, that would sort of take up some time for us as providers to do this.

	Now, video visits are not time-based, but complexity based very much like in-person visits, but then we also had to sort of figure out, we had to put in modifiers for if the patient was at home, versus if the patient was at the clinic and we were doing video visits with them. Further complicating it sometimes, is that it wasn't always clear as providers and we always needed to check in with our general counsel, if we could build telehealth if a patient happens to go out of state, or if we as a provider, were out of state and what were the sort of rules around that? Furthermore, at the beginning of each visit providers had to go through a script with the patient, we have to say, and this maybe probably was more legislation than reimbursement implications, but we still have to go through the whole process of saying, document that we told the patient that this is a telehealth visit. The legislation allows us to bill for the visit until so-and-so date, and that we need to give a verbal consent. We have to do this with every visit.

	The one pet peeve that I had also specifically with Connecticut, not allowing a medication assisted treatment as a first induction visit, that could not be by telehealth, that it had to be in person, whereas federal legislation or federal sort of guidelines allowed it to be by phone. In Connecticut, it's not, so that put a lot of ways of us trying to figure out how to get the person in, especially if an X waiver provider wasn't on site and how could we do it through telehealth and all the coding that we had to go around that. And so, that remained a barrier for us to be able to get people on treatment fairly quickly.

	But we are also seeing an increase in the unbillable number of visits, and only due to the fact that it was a time constraint, right? So if on the phone, you did 10 minutes with him, not 11 minutes, it became an unbillable visit. So we started seeing an increase in some of those and a big push to try to get people on video, but not very successful on that front as well. And so, that was an issue we had to continue to deal with. And lastly, I guess, we've been, sort of like what Julia was saying, we've been able to engage with patients through telehealth who either were not engaged before, or that we were able to engage with them more frequently, because we were able to do telehealth.

	So for instance, for me, I was able to engage with some patients I hadn't seen in a while, because now we're able to do telehealth with them, and so that was great. But on the other hand, we're also starting to see people that we hadn't seen in a long time. And so, we were starting to see people that stopped engaging with us, because of telehealth, but because of the issue of, although we engage with them, we weren't able to get, let's say, preventative care set up for them or some of the chronic disease management. So we're starting to fall behind on a lot of our patients on vaccinations and diabetic management and hypertensive management.

	So way forward, need to make sure that, I think, all forms of access to the care continue to be available and to be sort of reimbursed on an equivalent level. So phone, video and in-person, I think we need all of this to meet as many patients as we can, where they're at and therefore, also to decrease any bias, favoring one method over another. We also need to close that gap in care with telehealth, right? The idea of, that we're not seeing blood pressure sort of readings and A1C testing and STI testing and so on and so forth. And we can do this, right? The technology exists to start doing these at home, the self-testing and self-monitoring at home. I think we need to start to incorporate that as part of moving forward, in terms of telehealth. I think we need to streamline telehealth as just part of in-person care as well.

	I think making those distinctions of, we need to code them one way or differently or another, I think if a person is coming to see us at our clinic, the consent should be across the board for telehealth as well as in person, but I don't think we need to keep sort of repeating the consent with every visit from that front. And lastly, I think we should really look at telehealth being allowed across state lines for both providers and patients. I think that will just continue with continuity of care. We're able to do that, borders should not be a barrier anymore, I think. And so, we really need to take advantage of that.

Jeffrey Crowley:	Great, thank you so much. And my apologies, I touched my mouse and somehow I stopped screen sharing, so I apologize if that was an interruption for everybody, but we'll just turn now to Jean.

Jean McGuire:	Thanks, Jeff. And thank you, [inaudible 01:19:52], who I haven't seen in a long and others who have put together such an interesting discussion. I just wanted to start by saying that today happens to be the anniversary of George Floyd's death and it seems to be that there's something very right about considering strategies to further equity in this particular and important health arena.

	And in that respect, I really think that while it's important to get the optimum model and components here clarified, so this is from a payment point of view and what goes into that, it's even more important to keep asking which set of problems we think we're answering with this strategy, and are they the ones that will drive down differential risks and outcomes across gender, race, disease, geography and other circumstance, including household circumstance, which is now come up more than once in terms of everything from confidentiality to differential risk, in that setting.

	From an insurance payment point of view, we continue to have our differential STD risks in those parts of the country that have greater uninsurance. And so, I don't mean to be mundane, but remote access is going to mean something very different and drive different payer interest and approaches in my State of Massachusetts, where 98% of people are covered. They like to say more than that, but I think that's it. And over 90% of our STDs are diagnosed in integrated health system settings. So, that's maybe to [inaudible 01:21:31] point, sort of a continuum of things, but it's located, it's quite located. And that's going to be very different than in Texas, where the uninsurance rate continues to hover around 20%. So, among other things, the models that we're building, these products, they need to anticipate costs and payment options that will include settings that are differentially dependent on public clinics still, and lack of other third party reimbursement mechanisms.

	So, Jeff had asked me to look at big picture opportunities and I'm really going to do so by way of a few cautionary tales, recognizing that we've heard a lot and I'm very grateful for the update for myself about the potential and somewhat realized efficacy reach and acceptance of this strategy, so kudos to the presentations yesterday and the good work that's done. But when we're building an approach and we're thinking about sort of how to get it paid for, my first recommendation, I'm sure, Julia, we've billed beyond that, would be, we'll start with what you think is the optimum, because the likelihood is that it's only going to go down from there. And so, I really want to encourage everybody that's engaged in this process to continue to hold onto those core array of concerns that we've brought to STD related screening testing and treatment.

	But by way of thinking about how this has played out in other arenas, we've learned from various CMS and other care innovation demonstrations, adverts, including those that are in commercial insurance, that it's really tough to expand or alter our model once it has a cost associated with it. And I'm going to give two examples that are relatively recent. One is the Medicaid Medicare duels initiative that started about earlier this decade and really saw as a core aspect of its innovation, high touch and home-based interventions for high need individuals over time, both with physical and behavioral health impairments. And the significant detriment of that component that distinguished it during the demonstration and post demonstration kind of demonstration to a period is troubling in terms of the relative value that had been seen with it. Not that you don't test something over time, evaluated change.

	The next thing I would point to is more recent, which is the ACO DSRIP related developments. Also, again, created with CMS resources, but aligning with a lot of other ACO development in various states. And I think they've shown pretty disappointing results over the first three years in terms of what were supposed to be core considerations, which was integrated behavioral health initiatives and integrated social determinant of health efforts, as well as contractual arrangements. So, even when you start with a frame that imagines the optimum, the degrading happens quickly. So, what does that mean we need to think about here? And so, thank you to Guttmacher and other commentary, we still have to think about when we build the model and we think about the payment and therefore the players in the mechanisms, confidentiality in this arena is still important.

	Secondly, public health department, we can't lose our case ascertainment, so we want something integrated in terms of sort of the data that we can continue to appreciate preferably and we're a state among others, preferably still with racial and other important differential indicators, which have again, even as we've moved toward more integrated care and reporting, we get less race and sometimes even gender. But the concerns about patient related burdens, financial burdens that are incurred, whether it's with cell phone data costs and, or, accessing point of service lab or treatment stuff, need to be fashioned into the structure. And I know they were referred to yesterday in different ways and there's work around some strategies, but it's amazing how quickly cost becomes a barrier in this arena. The role of an actual development of payment mechanisms for high-impact behavioral counseling, that's already in place in STDs. We don't want to lose that, so how do we keep that as a sort of ongoing available strategy?

	And I'm going to speed myself up, because our time got a little constrained, I think, but I do want to say as I'm talking about model development, I think we have to ask the question, how are the strategies we've undertaken in HIV in prep, informative or different from other STDs? In terms of the STDs themselves, the nature of diagnosis and treatment, who that is that has them, et cetera. In terms of thinking about pay, so build the model right, then think about payer interest while you're doing it. Volume is incredibly important from a payer point of view and COVID's confirmed the system and people's ability to engage. However, we're also now seeing a downturn across the board in virtual visit utilization, uptick and in-person, and it started before we had vaccinations and it's represented both in commercial payers and in settings like community health centers nationally.

	So, value matters when a payer is thinking about what the relative value of an intervention is and the allocated cost to it and patient preferences in part drive that volume and they need to drive the model to development. So, in terms of those models, what's the new normal going to be and what is the equilibrium point when we're having tele availability? And I would say that the equilibrium point, and maybe this is reflecting [inaudible 01:27:43] too, is that hybrid models are going to be a part of the future. And we're already seeing, people mentioned Teladoc lately, we're already seeing places like Teladoc acquire bricks and mortar. So at the very point that we're going to click and mortar, we have bricks and mortar being integrated. And payers are going to want to see a complete continuum of services from self service apps, to multi-platform digital services, to face-to-face and cross system care coordination and data interoperability, all high bars.

	Being digital is not going to be enough for market sustainability and in the payment arena, ultimately we've seen some of the complexities that behavioral health has already had. An early adapter that has ongoing reimbursement problems, increased productivity requirements in virtual visits, greater use of extenders and nonclinical individuals in managing crisis calls and referrals and threats to payment arrangements. Moreover, three quarters of Americans are now covered through managed care and managed care entities and other plans are really developing model fatigue. They want diversity in terms of system but they want to reduce diversity in terms of system and platform interfaces. So Dr. Scott's reference to couture apps and other platforms, they prefer integrated delivery even if it's in a virtual mechanism, they're still adjusting their internal payment approaches to telehealth, which is a threat, maybe an opportunity, but they are pushing risk down and out. And they feel like they are already putting too many things under the hood of their capitations that are not associated with their bottom line and none of the [inaudible 01:29:21] well, the chlamydia measure are associated with any kind of payment incentive in terms of-

Jeffrey Crowley:	Jean, I'm going to have to interrupt you. I think we're going over time. Can you maybe just wrap up quickly?

Jean McGuire:	I'm at finally. Considering how to cost and structure payments for the public sites that are entirely or mostly discretionary and grant funded and how to align those with third party reimbursement that might be in the same setting is itself an additional challenge. And so, thanks.

Jeffrey Crowley:	Wonderful. All three of you, we packed a lot into 30 minutes, so thank you. And now, I'd like to turn it over to Gray Felzien who's going to lead our next discussion on communication technologies and rural health. Once again, thank you so much.

Title Slide:	Discussion Session: Communication Technologies and Rural Health

	Organizer: Gregory “Grey” Felzien, MD, AAHIVS

	Discussants:Dr. Michelle IandiorioMichael Ray Murphree, MSW, LICSWSuleima Salgado, MBA

Grey Felzien:	Thank you for this opportunity to have this discussion today on communication technologies and rural health. Very excited to be a part of this two day discussion and we're very excited to introduce the discussants today. They have extensive experience, years of working with communication technologies prior to the pandemic, working on establishing telehealth and other technologies with community partners through the epidemic and with expansion, and also in discussions of what's next, what's going to happen after the pandemic?

	So, I'm very excited to introduce first, Dr. Michelle Iandiorio, who is an infectious disease physician. She's a professor of the Department of Internal Medicine Division of Infectious Disease at the University of New Mexico Health Science Center. She's also the Clinical Director for the South Central ADTC and Medical Director for the HIV Tele Echo Clinic at the Echo Institute and at the Truman Health Services. We also have Michael Ray Murphree, who's the Executive Officer for Medical Advocacy and Outreach in Alabama. And also, Suleima Salgado, who's the Director of Telehealth Telemedicine and the Echo Project Manager for the Georgia Department of Public Health. And myself, I am Gray Felzien, I am also an infectious disease physician. I am the Medical Advisor for the Division of Clinical and Medical Services at the Georgia Department of Public Health.

	So first, our goal when we were asked to come together as a group to really discuss communication technologies is to really look at and illustrate the successes in remote care in rural areas and really excited that we were able to bring together individuals who work extensively throughout rural areas in their areas. And also, to identify some barriers working with community partners, looking at broader implementation of remote care and really to address HIV and STI prevention and care. And this really goes beyond even these subject matters. And we really want to understand the types of capacity that are needed in these rural areas to adopt and to expand remote care, so that really was the goal that we had for this group.

	Where accessing remote healthcare, the determinants are very short here, but they're actually quite extensive and looking at healthcare equity that we've heard about over the last day and a half, looking at barriers and successes in reaching these communities. And also looking at workforce capacity, we hear a lot about building, but it's also important to look at maintaining a viable workforce, especially in an era where we're seeing a lot of burnout, we're seeing individuals moving out of STI HIV healthcare into other arenas, and how can we maintain that viable workforce? And really looking at some approaches and telehealth, telemedicine, project echo, but also there are so many other modalities that go hand in hand, including electronic medical records and other things that we're going to hear about today.

	And really looking at outcomes. What is that going to look like moving forward? So, getting into the questions. I know that was pretty rapid, but I also wanted to really get to the panelists and hear from the experts across the country in what they're doing and how they're meeting these needs. So the first question really that was brought up is, what must be done to address rural culture barriers to preventative healthcare services in this arena. And I will open this up to Mr. Murphree, if you'll start the discussion.

Slide Description:	Discussion

	What must be done to address rural cultural barriers to preventive health care services?

	Cultural Barriers Limit Immigrant Patient Provider Interactions (patientengagementhit.com)

Michael Murphree:	Thank you, Doc. I appreciate it and appreciate an opportunity to be able to share with you all a little bit. So, we've been doing telehealth for about nine years now, so we were an early adopter based primarily on the fact that we were covering over 18,000 square miles of rural Alabama. But I'm going to go a little bit deeper today. I do want to address a real cultural sense that people need to kind of bring in, especially if they're working with communities outside of urban centers. My perspective is both professionally as having primarily served rural communities and rural people, but also, as an individual who still lives in rural Alabama in the same community in which I grew up. My grandparents on both sides were farm people, my grandparents on my dad's side were sharecroppers, so you can't get more farmer than a sharecropper in rural Alabama, I'm pretty clear.

	But one thing that both of those pieces of my life brought into the idea was that there is a rural cultural perspective, particularly in the South, but I found it outside the South. I found it in other parts of the country. And if we really want to deal with these healthcare issues in our country, we're going to have to deal with rural culture. And I have to say that I don't think America has done a great job at doing that, partly because we've always focused a lot of our messages on urban population centers, which makes sense, because that's where the bulk of the populations are. But unfortunately, that really fails to reach the people in these rural and small town communities, where morbidity is always going to be higher and I think most everyone has enough data to show that you will die from something more readily if you live in a rural or small town than you would if you were in a more urban center.

	And so, part of this one has been that if you look at what I term really healthcare culture in the rural and small town America, it's more crisis oriented when it comes to formal medical care. And by that I mean, people in these areas are going to go to a hospital or a doctor if they're in a crisis. When you talk about preventative, that's only going to be more homeopathic or remedy related. And I think if we have to really acknowledge that, many times people are going to wait till the last minute to go to a hospital or a doctor. And in areas which you do not have a lot of healthcare options, because in areas that have decided not to expand their Medicaid services, we really are seeing a lot of people who just are giving up going to any kind of medical care at all.

	I think also, when you look at that, we have to talk about why people aren't going to go and being here in Alabama, we certainly always discuss the Tuskegee study that they did and the impact. But I'm going to say that the Tuskegee study and its negative impact, that's not it, that's just one piece. There is a greater concern among people in rural and small town communities throughout the world about going to medical providers and it is very deep. And we're even seeing it in regard to the COVID pandemic that our vaccinations among rural people and predominantly Caucasians at this point in Alabama are not very good. Rural people are not comfortable going to formal medical providers and we have to address that certainly. Obviously, travel barriers are always going to be a problem for rural communities and in areas like ours, where we have a really reduced amount of medical providers, they're leaving our state, they don't get reimbursed well, so they're going.

	We've got to think about how we can make a change within our community. I think some areas in some states really should consider a nurse practitioner PA and even pharmacists, giving them more practice options where they can serve, because they're in these small communities, they want to stay there. And I think if we can look at their parameters and help them out by giving them more opportunities to do the care, will be a win-win overall. And I'd also think that certainly tele med as we've been doing for a long time has been a blessing to us and to the people we serve. And especially during the COVID pandemic, the telehealth link was incredible. And then lastly, I'm going to plant something with all of you that I really wish you would take to heart and think deep about and that is health literacy is an absolute must.

	If you are looking at underserved communities, whether it's an urban community, but especially in rural and small town communities, we have to go in and educate the folks that are there on really what health is about, what preventative healthcare is about. And we think that everybody knows this, but I'm going to assure you, they do not. We have people who are still not understanding why preventative healthcare is important. And one of the things I would suggest to us all is that we need to bring those to rural communities and address one major rural culture thing. And that is, rural culture is relationship driven.

	So, if we think we're going to put up a billboard or a radio commercial and it's going to reach them effectively, I'm going to say it will not. They need to know somebody and if it's homegrown, that'd be even greater, that they can come and do these programs, go to the church, go to a synagogue, go to wherever people are gathering, to be able to share the message. And those people are going to know that person, or know who their mom or dad might be and that's where your message is going to be embraced at that point. So I leave that with you all today as something to ponder. Thank you, Doc.

Grey Felzien:	Thank you so much and thank you for taking your time today to really give us some information that's so important to remember. Really, looking at the next question in this panel, is telemedicine for HIV here to stay? And it seems like such a simple question, but when we really think about telemedicine, telehealth, electronic health records and where we've been, is this something that we have seen such great things during this process and expansions, individuals with start-ups where they may not have started it up in the past, where are we going to go after the pandemic is over? So, I really leave this to Suleima Salgado to really lead us in this discussion.

Slide Description:	Discussion

	Is Telemedicine for HIV here to say?

	Various photos of medical equipment, a video chat, a backpack, and other telemedicine examples. Photo credit: Suleima Salgado, MBA

Suleima Salgado:	Thanks, Dr Felzien, again, I'm with the Georgia Department of Public Health. I think it's a really good point and there's been some great dialogue already regarding telemedicine and telehealth and the benefits of it, but really, is it here to stay and as stated by everyone else, it's one of those questions that is still up in the air. We know based on what we've heard from CMS, that yeah, telemedicine is here to stay. It's kind of like the whole, the cat's out of the bag. People have modified, people have leveraged telehealth, leveraged different technologies in order to address the needs during the pandemic. And we know that as it relates to HIV for prevention and management, we know the benefits of it already as it relates, just like you guys mentioned earlier during much of the other discussions, how it helps with travel and the overall stigma and just the accessibility and affordability for many.

	But when we look at it and we talk about it and we kind of flip back just as again, stated earlier, it was only available for those in rural areas. We were looking at those rural areas and even those incarcerated, but with the COVID pandemic, the way I see it for us, it was kind of like as a telemedicine kind of guru, we like to say telemedicine was kind of, in COVID, really helped us secure our jobs when looking at telemedicine implementation for agencies. And DPH was one of those locations in Georgia, where we had been implementing telemedicine for over 20 years. We started very small in some of our counties, and we didn't look at it as just a rural need, but we looked at-

	It's smaller in some of our counties, and we didn't look at it as just a rural need, but we looked at it as a way to better connect with our staff, to better connect with our patients. But it was always that entire traditional brick and mortar. So for us, telemedicine was patients were not still getting it in their home and it wasn't as convenient, but we were trying to make it convenient for them by leveraging our health departments in our specialty clinics and saying patients, while we know you might have issues with connectivity, broadband, and access, how about you come to our public health departments and we're centrally located so we can help you. And so we use traditional telemedicine where our health departments were those presenting sites. And we connected back to those specialty providers at the distant locations. And that was kind of what telemedicine traditionally looked like.

	But when looking at the COVID pandemic and everything that has happened, when we think about is telemedicine here to stay, we know it is. We know that there are so many modalities, whether it's looking at your video, a phone consultation was even allowed during this pandemic. But really now taking it a step further and saying, are you going to be using mobile apps, are using social media platforms as discussing medicine and what is going to be allowed? Honestly, I think we did let the cat out of the bag and we kind of expanded our reach and said by any means necessary to reach our patients. While that is a great thing, we need to take a look now and say, what is truly sustainable? What platforms are truly working, what work not only for us as organizations and individuals and hospital systems and providers, but what worked for our patients. How many platforms are patients leveraging now on their own to meet with multiple providers?

	We've asked patients how many different platforms are you using to connect to different providers outside of DPH? And we get anything from one to 12. Now, is that right? Is that what our patients need? Can they sustain that? Can we sustain that? What have we learned from a phone teleconsultation during this pandemic versus a video consultation? What were the benefits of each? We know that every situation is unique and there are patients have different needs, but was a phone consultation sufficient? Should we have gone even further into that video consultation and was the, or the team or the zoom, were those sufficient? Did we have concerns with HIPAA? What was the privacy issues? So I think that's something we need to really consider when we're talking about is telemedicine here to stay. We know it is. We know it's going to be the demand. We know people are going to constantly be asking for a video platform now.

	If anything, because of the convenience, but what is truly what we need. And the biggest question I know everybody has is will insurers continue to reimburse? Again, you're only able to be within a certain metropolitan area or in a certain rural area to be reimbursed initially. And now with CMS extending, hopefully through the end of the year, we are able to provide it to everyone. But what will stay, what will go and what can we do individually to make sure that our patients are receiving the best care. What modifications do we need to make, or are patients able to take their own vitals? Were we able to look at areas of concern. When looking at derm and skin consultations, was that sufficient, was then taking a picture on their smartphones for those that even had a smartphone and us to go back and review those images, did that suffice? Or do some of these services need to transition back to in-person and if so, what modifications can we still make to help our patients?

	So I think that's really where we're going. And I think there's been so much discussion that we kind of already knew this. But not only are we just considering telemedicine as this different way, leveraging all this technology, but I know earlier it was even mentioned, Jean mentioned kind of just the Teladoc. We've seen Teladoc explode and patients taking kind of management and control of their own care. But do you streamline and go back a little bit with telemedicine and say, is this taking away from our patient's medical home? Do we need to find a way to coordinate and bring them back centrally? What else can we physically do? And I think that's the most important thing for us. But not only that, when we talk about is telemedicine here to stay, are we jumping too far ahead of ourselves? I mean, in Georgia, I can say that out of the 159 counties, we have, we have a telehealth connectivity and presence of all of our counties through our health departments.

	But the biggest issue our clients are still facing is something as basic as broadband. So do we continue the march broadband for all and do anything and everything we can in our States to ensure that all of our patients have quality internet capabilities and broadband to actually connect to a consultation. And then really look at the billing restrictions. I know as telehealth kind of texts and program implementers, that we want to push and continue to push telemedicine expansion. But can we pause now and look at satisfaction, look at data results, look at the evaluation piece from our clients during this pandemic, and really hear from them and learn what worked, what didn't, what changes we need to make and where do we need to start over? So I'll pause right there. Thanks Dr. Felzien.

Grey Felzien:	Thank you, Suleima again. It looks like an easy question and very complicated way that we really need to think about is telehealth telemedicine here to stay. So thank you so much. If we have time, we're going to have a fourth question, but let's bring this to the next part of the discussion of how could telehealth be used to increase the knowledge and skills of the available providers in rural areas so they can appropriately screen for and treat the conditions we're speaking on. And I'll just say, I mean, I'm a rural provider and I grew up rural on a farm in Kansas for many years. And we really have to think about how individuals are isolated in these rural communities. And we know also the burnout of, prescribing providers is twice that of the general population and some of these rural communities. And here in Georgia, we recently had a provider move out of the Ryan White system, which really left a huge, huge hole for that community. So I'll leave this to Dr. Michelle to lead this discussion and welcome. And thank you for being here today.

Slide Description:	Discussion

	How could telehealth be used to increase the knowledge and skills of the available providers in rural areas so they can appropriately screen for and treat these conditions?

Michelle Iandiorio:	Thank you so much, Dr. Felzien. So I'm going to utilize the term telehealth in the more broader sense rather than telemedicine alone. Is really to talk a little bit about the ECHO model, which has a tele mentoring program, specifically addressing the concerns that have been mentioned so far today. So what we've heard from our first presenter is really the importance of relationships. I would say all over the world, but yes, in rural areas as well, and that patients have relationships with their local providers and a lot of trust is established with their entire interprofessional team. And so that utilizing the ECHO model is not direct patient care, which is dissimilar to telemedicine, which is a provider to direct patient care. This instead is for increasing workforce capacity. So rather bringing the knowledge and the skills to the local provider so that they can best care for their patients in their local area and thus increase their capacity.

	So we utilize, we ensure providers have the up-to-date knowledge, and we're talking about HIV prevention, STI treatment. We know these guidelines are continuing to evolve over time. And so it can be challenging to stay up-to-date on all these recommendations. And sometimes these conditions are perceived as being very complex to care for. And so having a group of mentors and a community of practice where local providers do not need to feel isolated in their care for patients who could be complex, but rather feel supported by this community of practice, including content experts and that may include STI and HIV content experts. But also colleagues who are also in rural areas who may be best placed to offer guidance about what resources are available in other local areas.

	In utilizing the ECHO model is also an interprofessional team so recognizing the team-based approach to outstanding patient care, particularly when some specialties may not be available in all rural areas. So the idea is to increase the comfort level and the willingness of providers in rural areas to care for patients with these conditions and to do so in a best practice method. So we want to move knowledge to the healthcare providers rather than moving people, so that the patients themselves don't have to travel hours outside of their area to seek care.

	So utilize an ECHO model. It's an all teach, all learn, so really helping to reduce any sort of barriers or hierarchy amongst the team. And so that in addition to healthcare providers, having that excellent relationship with their patients in order to provide excellent care, is community practice over time builds on these interprofessional teams with various content experts really establish those relationships because we're all learning from each other. So another potential strategy to ensure that patients have access to high quality care. Thank you, Dr. Felzien. I'll hand it back to you and the rest of the panelists.

Grey Felzien:	Thank you so much for that overview. And I've been involved with ECHO for many, many, many years, and I know in your video, and you may want to share your website in the chat box, so individuals can get more information if they're not well versed in ECHO. But in your video, it shows this young family practitioner up in Alaska who suddenly becomes a very strong rheumatologist in her community because of ECHO and because she has removed that isolation and has connections with the ECHO community to learn more about rheumatology in that situation. We do have a couple of minutes and I'd like to bring up one question and maybe each of you can give a 30 seconds or 45 second blurb. And this was brought up by, I think, by all of you during the conversation. And that's really the concept of training.

	And one of the things that is very frustrating in the fields that we have chosen is we have such turnover in many of our clinics. So we may have, we had a clinic here in Georgia that in a 12 month span had an 80% turnover of their staff. And that makes it very difficult. So we do hire some individuals that have a more extensive HIV experience, but we do hire a lot of individuals that are new to this. So with this turnover and need for training, how do each one of you kind of reach out and build that community to connect folks into the systems so that they don't feel isolated and and they remain, for years to come, caring for the populations we serve. Michael, you want to start us off since you kind of started that process of talking about turnover.

Michael Ray Murphree:	So from our perspective, one of the things that we've been able to survive about is actually huge amounts of community collaboration. We do our direct practice tele-medicine sites that are FQHC public health departments and some UNB sites. And we do the direct link to them with a local nurse that works with our recipients and patients. And I think part of that one is just that constant engagement of all your partners out there when you don't have a whole lot of resources, especially in many parts of the country that are poor. So you really do kind of connect and build a network of providers. They may not be your own, and they will help sustain you when your people may be [inaudible 01:54:19] out. You'll be able to at least be sustained for a while.

Grey Felzien:	Thank you so much. And Suleima, if you could touch on, you spend so much time of individuals saying, Oh, I want to do this, I want to do this. And then there's these delays of getting this process. The technology is there, you upgrade the broadband to T1 lines or T10 lines. Discuss that on kind of those challenges, just in a 30 second, 45 second blurb on how you work with that and how you kind of push folks to move forward in this engagement.

Suleima Salgado:	Yeah, that's a great question. I think for us, it's really our success through Georgia, even kind of not making it the one size fits all. We have really taken the time and making sure that one of the biggest pieces is that our communities really go in and do an analysis of their needs and their audience. Is not pushing something down from the state and saying as a state agency, here's how telemedicine has to look through public health. And knowing that each of my health districts in each of my communities are very different.

	And saying beforehand, let's take a look at first, what resources do you have around? Do you have bandwidth? Do you have high quality bandwidth? Do you have connectivity issues? What providers are in your area? Where are your patients currently going? Are they public health patients? Are they being referred out? What does that look like? And then collectively coming up with a vision and mission to strategize and implement. So for me, my job at the state office when implementing telemedicine, is to know that every one of my communities are unique and that while we may have a toolkit, that toolkit and toolbox will be adapted and adjusted for each of my health centers.

Grey Felzien:	Thank you so much. And Dr. Iandiorio I'm going to go a little bit off script here also, because just my experience with ECHO is trying to get individuals involved. We get a pushback saying from folks, Oh, I don't have enough experience to be involved with ECHO or what happens when I become knowledgeable? Do I graduate out of ECHO? And we constantly have these discussions that this is a community involvement of people coming together at all levels. So can you touch on that a little bit in the last minute that we have.

Michelle Iandiorio:	Sure. Happy to, thank you. So utilizing the ECHO model and really building that community of practice, as you said, so some people come in new to a particular disease state or management of patients. And then over time they develop knowledge and expertise and become experts in that content area themselves, and sort of become part of the consultative team themselves. And so really, as a local leader in that particular healthcare condition where they can act as a local resource for other providers in their area for that particular disease knowledge content. And so really helping establish their, their expertise is really key.

	And so, and also to go along your question, so how do we ensure that healthcare providers are kept up to date? And I really think, obviously the ECHO model and the community of practice, I'm biased. I have these logos here. Also the ATC right in there, education and training programs. Also there's, the STD prevention and training centers. So these are national organizations really built to help local providers stay up to date on these content areas. And there are local providers partner sites that have connections with local providers to ensure that trainings are targeted to their specific needs. And so I encourage you all to reach out to those training centers. Thank you.

Grey Felzien:	Thank you for that last comment here in the last minute. I have folks that are new to HIV care also. They get very overwhelmed. They're being told, Oh, just go look at the guidelines. Well, that's 200 and some pages, very overwhelming. So I'm glad that you mentioned that the ATC, the ECHO model. We also have the University of Washington national HIV curriculum, which under that curriculum also has hepatitis both C and B. Also has a sexually transmitted infection. So they're great resources to be able to, for those that are new or very experienced, that need that quick information, that they're wonderful ways of reaching out and getting that information. So again, that was a quick 30 minutes. Lot of information. I want to thank the panel. What a wonderful discussion between one and two o'clock. We will have a break, but please come back at two o'clock. We'll start back with remote health decreases health inequity that will be chaired by Leandro Mena. So everyone have a wonderful lunch and we'll see you back in an hour. Thank you so much.

Title Slide:	Thank You

	Gregory “Grey” Felzien, MD, AAHIVS (They/Them)Medical Advisor, Division of Medical and Clinical Program ServicesGeorgia Department of Public Health

	Michelle Iandiorio, MDProfessor, Dept of Internal Medicine, Division of Infectious DiseaseUniversity of New Mexico Health Service CenterClinical Director, SCAETCMedical Director, HIV TeleECHO Clinic; ECHO InstituteTM & UNMMG Truman Health Services

	Michael Ray Murphree, MSW, LICSWExecutive Officer, Medical Advocacy and Outreach

	Suleima Salgado, MBADirector of Telehealth, Telemedicine, and ECHO Project ManagerGeorgia Department of Public Health

Title Slide:	Debate: Remote Health Decreases Health Inequity

	Moderator: Leandro Mena, MD, MPH, FIDSA

	Pro: Jennifer (Jen) Kates, PhDKFF

	Con: Gregorio (Greg) MillettamfAR

Leandro Mena:	Good afternoon, everybody. It is my distinguished pleasure to welcome you to our debate station. Thank you to the organizers for inviting us to this debate station. I'm a moderator. My name is Leandro Mena and I'm an officially [inaudible 01:59:21] physician in Jackson, Mississippi, where I chair the department of population of science at the University of Mississippi Medical Center. But that'll do. Our debate is promote health decreases healthy inequity. Our debaters today need no introduction to this group. Dr. Jen Kates will present the pro arguments. She is senior vice president and director of Global Health and HIV policy and the Kaiser Family Foundation and Greg Millett presenting the con arguments. He's a vice-president at the foundation for AIDS research and the director of the DC based public policy office. Each of them will have seven minutes to present their arguments followed by three minutes each for rebuttals. Welcome Jen with the pro statements.

Slide Description:	Remote Health Decreases Health Inequity: Debate Session

	PRO Postion: Jen Kates — May 25, 2021

Jen Kates:	Thank you, Leandro. And hello everyone. It's good to be here. Before I get started. I just want to say that my view of this is that there is no exactly right answer. I'm going to try to share information that suggests that remote health and telehealth can actually contribute to increasing equity. But we will see how we go along with that. And also, I should say, this is not representing KFF. This is just for purposes of this session today. Next slide please. So the position that I'm going to talk about or take is that telehealth may offer an important compliment to, and in some cases, substitute for in-person HIV and other STI services, and may there therefore help to increase health equity for some populations. Next slide. So we know that there's lots of barriers to HIV and other STI prevention and care services.

Slide Description:	Among the Barriers to HIV and other STI prevention and care services are:

· Stigma (community & Individual

· Lack of Transportation

· Lack of Childcare

· Can’t Take Time off Work

· Distance/Geography

· Lack of Providers/Facilities (particularly in rural areas)

· Other Competing Needs

	Sources: Pellowski JA, Barriers to care for rural people living with HIV: a review of domestic research and health care models. J Assoc Nurses AIDS Care. 2013;24(5):422-437, doi: 10.1016/j.jana.2012.08.007. HRSA, National Advisory Committee on Rural Health and Human Services, May 2020

Jen Kates:	And I'm going to talk about some of them here. And I also know that all of us are very much thinking almost entirely about COVID-19, but these barriers of course existed before COVID-19 and will continue to exist after the pandemic. But I think the pandemic has at least catapulted us many years ahead in terms of telehealth and it's here to stay. So it really behooves us, I think, to make it as good as it can be. So among the barriers that we know, the populations that we are trying to reach face. A big one is stigma. And it's important to articulate that this is not just stigma at the individual level, somebody feels uncomfortable, potentially seeking services. They're not quite sure of their, what it might mean for themselves. There's also community stigma, the fear of going someplace to seek services and stigma that might come with that, that they at least perceive. Obviously, lack of transportation, getting to a appointment can present challenges for people.

	Childcare is a barrier. If you do not have childcare or are not sure where you can get it, you can't always count on getting to an appointment. And similarly, can't take time off work. And we know that that, all of these affect certain populations, more acutely. Certain types of work environments are going to be less forgiving for allowing people to have time off of work. And I'm talking here primarily, non COVID times. And then distance geography. If you live far from a facility, getting to an appointment, especially potentially not for emergency care, but really for care that you need that before something gets to an emergency, could present a real challenge. And then related to that is the lack of providers or facilities, particularly in rural areas. In some places where people live, it's just not, there's no provider near them.

	In addition, from a provider's perspective, it's not always cost-effective or easy to stand up facilities in sparsely populated areas. And then there's also, of course, a whole host of other competing needs that individuals face, that present barriers to them. Physically going to get services, whether it's on the prevention or the care side. Next slide please.

Slide Description:	What are some of the benefits of Telehealth?

· Patient satisfaction and acceptability

· Increased access to care and improved health outcomes

· May help to reduce patient anxiety and stigma, allow for privacy

· Help to engage and re-engage clients, improve retention

· Offers greater flexibility

· Reduces costs to clinics

· No need for transportation, or geographic proximity

	Sources: Innovations in Human Immunodeficiency Virus (HIV) Care Delivery During the Coronavirus Disease 2019 (COVID-19) Pandemic: Policies to Strengthen the Ending the Epidemic Initiative — A Policy of the Infectious Diseases Society of America and the HIV Medicine Association. Clinical Infectious Diseases, Volume 72, Issue 1, 1 January 2021. IDSA, Position Statement on Telehealth and Telemedicine as Applied to the Practice of Infectious Diseases, Clinical Infectious Diseases, Volume 68, Issue 9, 1 May 2019. Koester K et al, “A Good Habit”: Telehealth PrEP Users Find Benefit in Quarterly Monitoring Requirements, JIAPAC, Volume 19: 1-9, 2020. NCSTD, PrEP Telehealth, 2018. Budak1 et al, The Impact of COVID-19 on HIV Care Provided via Telemedicine—Past, Present, and Future, Current HIV/AIDS Reports, 2021. National Health Care for the Homeless Council, COVID-19 & the HCH Community Ensuring Access to Care Through State Medicaid Telehealth Policies, 2020. KFF, Telemedicine in Sexual and Reproductive Health, 2019.

Jen Kates:	In the literature, there have been benefits documented from telehealth. And I'm going to just highlight the ones here. In many studies now, patients or clients are satisfied and find it acceptable to receive some services through telehealth. It has been shown to increase access to care. And in some cases, even improve health outcomes. telehealth may reduce anxiety and stigma getting at those issues of both individual and community stigma that I mentioned. Allowing for a level of privacy that might not be there, particularly in communities that are smaller. And it's been shown to help engage and re-engage clients and improve retention.

	Offers greater flexibility. If somebody can't leave their office or their site of employment, perhaps they can find time later on in the day or the evening, to do a telehealth appointment. It reduces cost to the system. And of course, there's no need for transportation. You do not need to live near your provider. In studies that I looked at in preparation for today, I found benefits to lots of different populations, including some very, very disadvantaged groups. Transgender youth, transgender women of color, many with HIV, prisoners with HIV. Individuals we might think are facing some of the biggest barriers to seeking care that can benefit from this new technology or this increase use of telehealth options, remote options. Next slide. 

Slide Description:	Telehealth is supported/recommended by:

· Infectious Diseases Society of America

· American College of Physicians

· American Medical Association

· American Academy of Pediatrics

· American College of Obstetricians and Gynecologists

· HRSA’s National Advisory Committee on Rural Health and Human Services

· President’s Advisory Council on HIV/AIDS

	Sources: And IDSA position paper. ACP, https://www.acpjournals.org/doi/10.7326/M15-0498; AMA, https://www.ama-assn.org/practice-management/digital/digital-health-payment; AAP, https://pediatrics.aappublications.org/content/136/1/202; ACOG, https://www.acog.org/news-articles/2020/08/acog-gains-ground-on-expanding-telehealth; HRSA National Advisory Committee on Rural Health and Human Services, https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/rural/publications/2020-rural-hiv-prev-treat-call.pdf; PACHA, https://files.hiv.gov/s3fs-public/PACHA-Resolution-on-Innovation-in-EHE-Oct-2019.pdf and https://files.hiv.gov/s3fs-public/hiv-and-covid-draft-resolution.pdf.

Jen Kates:	And because of this, there are many associations that have come out in support of telehealth. IDSA for one that all of us are familiar with, but many others.

	And I just wanted to note that recently, and these were two recommendations that came out prior to COVID-19 versus national advisory committee on rural health and human services, came out in support of telehealth and the desire to increase it as an option. And the president's advisory council on HIV AIDS, Pacha passed a resolution to improve how telehealth options prior to COVID, and then reaffirm that during the pandemic. Next slide. 

Slide Description:	Survey of Ryan White Grantees on Impact of COVID-19

· Survey sent to all Part C & Part D providers — 390 deduplicated

· 42% response rate, good regional diversity

· Fielded: Aug. 18 – Sept. 4, 2020

· Closed and open-ended questions

· Asked about RW and non-RW funded activities

	Source: KFF. Delivering HIV Care and Prevention in the COVID Era: A National Survey of Ryan White Providers, 2020. 

Jen Kates:	I'm just going to highlight some data from some work that we did at KFF. We surveyed Ryan White grantees to understand the impact of COVID-19 on their work and their clients. And we sent a survey to all part C and part D providers. That was about 390 and we got a pretty good response rate and regional diversity. This was fielded last summer. And we asked both about their Ryan White funded activities and non Ryan White funded activities.

Slide Description:	Almost all Ryan White Grantees moved to telehealth to address COVID-19

Two pie charts showing percentage of grantees who either offered telehealth or were not offering telehealth nor planned to offer it in the future. Prior to the COVID-19 Pandemic 79 of grantees offered telehealth. Now 99% offer telehealth.

	Source: KFF. Delivering HIV Care and Prevention in the COVID Era: A National Survey of Ryan White Providers, 2020. 

Jen Kates:	Next slide. What we found, and maybe not a surprise, is that essentially every single grantee, maybe except a couple, move to telehealth. And prior to the pandemic, about a fifth were offering telehealth. Now, every grantee practically was offering telehealth, which they were permitted and encouraged to do. Next slide. But we asked them, were there benefits to doing so? Or we presented it very objectively. And these were some of the things we heard. They felt that they were able to connect with historically hard to reach populations that they could not reach easily before. They could stretch their time, it was not as time crunched for them. They were able to get some patients retained in care and improve their ability to get services and their no shows declined. I want to highlight these next two points, cause I think they're very important to the argument I'm making.

	They felt that this worked best for routine visits, for follow-up care and for prescription refills. Again, this is important because I think it suggests that we're talking about something that can be very beneficial in certain circumstances. They also said it worked best for younger individuals, people living in rural areas, those with childcare responsibilities, who could not take time off from work, medically uncomplicated individuals and established patients. This is not everybody, but this is, these are individuals who face some of those competing barriers that I mentioned. Next slide. 

Slide Description:	Bottom Line:

· Remove Barriers

· Provide multiple doors of entry

· There is no one size fits all for every client

· Telehealth may offer an important complement to, and in some cases substitute for, in-person HIV and other STI services, and may therefore help to improve health equity for some populations

Jen Kates:	So putting all of this together, I think it's important to see this as an option that removes barriers. We, of course, want to provide multiple doors of entry. We know there's no one size fits all for every client and for every client at every point in their need for services, whether it's on the prevention side, the care treatment side, whether it's follow-up or as a new appointment.

	And so telehealth may offer an important compliment, as I said, or substitute for in-person services. And lastly, it's not on here, but I think we now know that remote health is here to stay. We don't know if how much of a share of our health seeking experiences it will be. But we know that that has changed. So it behooves us to make it as good as we can for as many clients as we can, knowing that it will not be for everyone. But when it is used, when it's treated similarly, when the challenges that we identified at in-person care, where you need to have cultural sensitivity, we need to break down barriers for individuals. We have to approach telehealth the same way. And if it's done right, I think it can improve equity for some populations. Thanks.

Slide Description:	Will Telehealth Promote Greater Equity?

	CON Postion: Greg Millett amfAR

Leandro Mena:	[inaudible 02:08:53] and now

Greg Millett:	Let's see. I wasn't sure if Leandro was frozen. Oh, okay. Well, good afternoon everybody. My name is Greg Millett and I am going to present the composition. But before I begin, both Jen and I have known each other since college/ we've been friends literally since college. There is rarely a thing that we disagree on. So I think we both found this exercise really difficult. To take these two very extreme positions, knowing very well that there's a lot of nuance that's associated with all of this. So with that said, let me go ahead with my first slide. So we are seeing that household internet service demographics are changing.

	So, from 2019, 1997 through 2019, we're seeing an increase in the percentage of households that use the internet. And we're certainly seeing in 2019 that middle figure that, a plurality of individuals by race and ethnicity in these households are using the internet. But what we are also seeing is that there are these disparities in terms of broadband internet connections, with 25% of black households that lack broadband internet, 20% of Latino households as compared to 13% of white non-Hispanic households and 7% of Asian households. Next slide, please.

Slide Description:	Household Internet Service Demographics

Bar chart showing the percentage of households with internet use in the United States from 1997 to 2019 (numbers are too small to read)

Bar chart showing the percentage of U.S. population with internet access as of November 2019 by ethnicity (numbers are too small to read)

· 25% Black households lack a broadband internet connection

· 20% Latino households lack a broadband internet connection

· 13.4% white, non-Hispanic households lack a broadband internet connection

· 7.5% Asian households lack a broadband internet connection

Greg Millett:	So research to the pandemic, prior to the pandemic found that older Americans, rural communities, vulnerable populations, racial and ethnic minorities, and those with lower SES are all groups disadvantaged by the digital divide. And unfortunately that has not changed even during the pandemic. And now afterwards, in fact, we're seeing perhaps that there's a widening of this digital divide. Next slide. So I'm going to go ahead and give you a couple of points. The first point is that telehealth leaves most vulnerable populations behind. And these are data that were published in New England Journal of Medicine by UCSF, where they're wondering whether or not addressing equity in telemedicine during COVID-19 was going to increase equity.

	And what they found is that it doesn't. So for the first figure that you can see there in the middle, you see the differences in blue are prior to telemedicine participation in visits, and then after telemedicine implementation. And you can see that older individuals were far less likely to have a patient visit after telemedicine was implemented. The same thing with people who were monolinguals, speakers of other languages beyond English. Also for people who mainly got their insurance from Medicare, we're less likely to have patient visits for telemedicine, same with Medicaid. And then we're also seeing by racial ethnic group to the right-hand side, no matter if they were African-American, Latin X, Asian Pacific Islander, that there was a drop in patient visits across all racial and ethnic groups, except for whites where you saw an increase in patient visits after telemedicine was implemented. Next slide.

	And unfortunately there's a bevy of studies that find exactly the same thing. That telehealth really leaves the most vulnerable behind. And I picked this study that was published in JAMA for a reason. Because it really gets into some nuances that we see with it. You could see a first plot to the left that looks at the adjusted odds for a telemedicine visit to completion. And what you could see is that older Americans over the age of 65 and older, were less likely to have a telemedicine visit. You also see that individuals who are non-English speaking were less likely to have a telemedicine visit. And those with Medicaid versus insurance, were less likely to have a telemedicine visit.

	The very interesting thing is when you take a look at the first plot to the right, which looks at the use of video during telemedicine visits, and you can see that nearly everybody is to the left. That they were less likely to use video from people who are older age, by race and ethnicity, even though it's only statistically significant for black and Mexican communities, by the type of insurance people have, Medicaid or Medicare or even household income. And I would wager that'd be very difficult to have a good and effective telehealth visit if you actually don't have a video on. So this is something that's definitely concerning and certainly where we see some populations that might get left behind. Next slide.

	And unfortunately we see exactly the same patterns for these health disparities, among people living with HIV and AIDS. There was a nice presentation in CROI this year, where they found that patients identifying as black were 77% less likely to have completed a telehealth visit compared to white patients. That people who were on public insurance were 76% less likely to have a telehealth visit compared to those who did not. And that people living with HIV with a detectable viral load, we're 66% less likely to have a telehealth visit. So this is still something that unfortunately is not reaching the most vulnerable among people living with HIV either. Next slide.

Slide Description:	Screen shot of an article titled “Differences in the Use of Telephone and Video Telemedicine Visits During the COVID-19 Pandemic” and a plot showing the data (numbers too small to read). 

Quote: “The hierarchical model revealed that practice (38%) and clinician (26%) factors accounted for more of the variance in video visit use than patient-level factors (9%)...”

Greg Millett:	And I think the second point that I want to make other than the first one of leaving populations behind is that the organizational capacity for telehealth is also an issue. There's a really nice paper that was published, where you can see in the first plot, that they basically found a lot of the things that I covered beforehand in terms of the populations who are less like they'd have a telehealth visit. But one other thing that they found in their analyses is that a hierarchical model revealed that the practice or a clinician were factors that accounted for more of the variants in having an actual telehealth visit as compared to patient level factors. So there's something going on with some of these practices or some of these clinicians that they were not initiating a telehealth visit. It could be that they didn't have access to broadband. It could be that they didn't feel that they had the capacity to do it, but organizational capacity is also an issue. And this is a two-way street. It's not just the capacity for the patients. It's a capacity as well at the organizational level. Next slide.

	And this brings us to Martec's Law. Actually trying to find her or his first name, but apparently it's just Martec. It's more like Beyonce or Drake, just Martec. But basically his law, or her law is that technology outstrips organizational change and shows that over a period of time, technology changes exponentially, but organizations change logarithmically. And that there's this challenge of this yawning distance between the two over a period of time and management must choose carefully when and how to adopt changes that would be in accordance with some of these technological advances. Next slide. 

Slide Description:	Throwing technology at a problem is not always a solution (nor will it overcome disparities) 

Screenshot of a Washington Post article titled ”Four years in, $147M laptop program has produced little change in student achievement.” Also shown in a quote from the article.

Screen shots of texts between a doctor and her patient.

Greg Millett:	And this brings me to my third point, that throwing technology at a problem is not always a solution, nor will it overcome disparities. And we certainly see this in the education field where giving laptops to children has not necessarily been shown to be effective in increasing education or educational gains. So for instance, in Baltimore nearby to here, to DC, there's 147 million that was spent on a laptop program, but it did not increase the test scores for the children who had had the laptop even three years after the program was initiated. And to the right, I was just including some texts from a Dr. Elaine Kuhn, who was talking about her recent tele-health visit. And I just really want to take a little bit of time just to read this. I call Mrs. Lee, an immigrant in her late '50s for a follow-up appointment to see how she's doing with her several chronic conditions. After we say our hellos, I asked if we can switch to a video visit. She sounds uncertain and tells me that her son who helped her access the app last time isn't available. That's okay, I say patiently. Do you know how to find the program he used on your phone?

	"I think so," she replies. I help her find the app and enter the meeting number for the appointment. A few minutes later, she declares triumphantly. "I can see you." I can't see her though. Oh, she replies slightly disappointed, "Is my video not on? How do I do that?" I talk her through the steps. A few minutes later, we finally see each other. Unfortunately, the sound quality is poor. Do you know how to join the program's audio I ask, but she doesn't. That's all right. I reassure her and proceed to guide her through the steps for using speakerphone. Finally, about seven minutes into our scheduled 20 minute visit, we're ready to discuss her many health concerns. So this really exemplifies some of the issues and some of the disparities that we see amongst some of these groups, older Americans, people who have lower incomes, people in rural areas where tele-health really may not be as optimal as many of us thought it would be, next slide.

Slide Description:	Screen shot from Vox showing article titled “Technology Made Health Care Expensive. Can It Now Control Costs? A new class of digital entreprenuers is needed to solve health care’s biggest problems” There’s an image of a 100 dollar bill showing Ben Franklin wearing a mask.

Greg Millett:	And last, health tech, is it really a solution or is it giving us more problems? There was a really nice paper that was published in Vox looking at technology and how it's made healthcare more expensive and how can we control some of these costs? And that's buttress by several different papers that have come out. One is from MIT Technology where Jonathan Gruber, who's an economist at MIT said, "In healthcare, new technology makes things better, but more expensive." And then also there was a CBO report that was released in 2008 that found that the general consensus among health economists is that growth in real healthcare spending was principally the result of the emergence of new medical technologies.

	And then third, there was a report from the Commonwealth fund that the higher prices we pay for healthcare and perhaps our greater use of expensive technology are more likely explanations for high health spending in the US and fortunately, we do not seem to get better quality for the higher spending. So all of this is a long way to say that perhaps telehealth is not going to get us to greater equity. There was a discussion yesterday about Alexander Graham Bell and an anecdote about how he hoped that the use of the telephone was going to make things better for doctor's visits, but that did not come to pass. And we're still waiting for technology to bridge some of these inequities.

Leandro Mena:	Thank you, Greg. So now Jen will present her rebuttal.

Slide Description:	REBUTTAL — PRO POSITION

Jen Kates:	All right. I want to say, I actually agree with everything that Greg presented. I think that those are really, really important data and we know those data are there and we know that that means the work is going to be challenging. I think that the main response I would give is that, telehealth is here. The change has happened. And so the challenge to all of us is to make it work as best as it can, especially for the populations who might be left out. So that's one, two, one of challenges with some of the studies that show that there are these inequities, the use of telehealth or remote health during COVID, it's hard to assess how much of that is the telehealth technology itself or the circumstances that have affected different groups in COVID itself.

	And so we don't know, for example, that woman who was struggling to get onto her remote session, would she have been able to take whatever transport she would have needed to take outside of a COVID lockdown and take time away from something else to actually get to a physical appointment.

	And what other impacts would that have on her life? It's hard to know those things. Third, I wanted to highlight the populations that I saw in the literature that said they would benefit from telehealth. I mentioned them before, but there was a study done, mostly qualitative research looking at transgender, women of color about, would telehealth be acceptable. And what this research has found is it certainly would be if it was designed appropriately. And one of the things that the women in the study said was that they were tired of the healthcare system. They were tired of going to a physical health care appointment and facing stigma and discrimination, and having to always explain who they were, and also the time and the competing needs. And they thought that telehealth would give them another way to get what they needed.

	There was a study with transgender youth who felt, yeah, young people, we know like technology and felt comfortable with it. And particularly those who had parents who were not accepting of them were much more likely to want that option. And then third, there was a study with homeless populations that actually found this is, gets at one of the studies that Greg mentioned that especially if there was an audio only option, it really did help increase access to a population that did not have a lot of stability. A fourth thing is that one challenge we have in our area, HIV and STI in particular is this decreasing number of providers. And so this would allow, in terms of finding providers near you, especially, this would allow more touchpoints, technological touchpoints for people, no matter where they were. And then finally, I do agree that technology has driven up healthcare costs. It's not clear that that technology though is the telehealth technology. It's often the technology of interventions and use medicine itself. Thanks.

Leandro Mena:	Thank you Jane. Now, Greg is going to give his rebuttal.

Slide Description:	Everett Rogers Diffusion of Innovation

	Graphic showing a rise and fall progression from early market to mainstream market with a chasm in between the early adopters and early majority.

	Innovators/tech enthusiasts present 2.5% of the early market, while early adopters/visionaries have 13.5 percent. Then there is a chasm before the mainstream market. The early majority/pragmatists are 34% of the mainstream, late majority/conservatives also have 34%, and the laggards/skeptics have 16% of the mainstream.

Greg Millett:	Jane, I see your rebuttal and I up you one more. No, I agree with you completely that there are definitely some populations who could benefit from telehealth and what I would hope with many of the people who are on this call is that we could actually see a meta analysis of all of the studies that have been done so we could see where telehealth has been useful, where it hasn't been useful, and also give us ideas of where we might want to go in the future.

	But I do want to take a sort of a 3000 foot view, just sort of an Eagle's view of telehealth and where it fits into where our nation is right now. Many of us already know about Everett Rogers and his diffusion of innovation theory, where there are innovators and early adopters of new technologies. And there's the early majority, the late majority and then so a group that people call the laggers. And I've always bristled at that term, the lagger, because it usually encompasses people who probably don't have the capacity to have access to a particular innovation that we have, next slide.

Slide Description:	Telehealth is not yet widely embraced (source Jaffe et al., 2020)

	Bar chart with age group on y axis and % respondents on x axis. Categories: no encounter, 1 or more in-person encounter only, and 1 or more telehealth encounter. Total are 67.2% no encounter, 30.9% 1 in-person only, and 1.9% 1 ore more telehealth encounter. Total telehealth encounters as a percentage of total encounters is 5.8%. For ages 18-44, 74.3% had no encounters, 23.5% had 1 or more in-person encounter, and 2.2% had 1 or more telehealth encounter. Telehealth encounters as a percentage of the total for 18-44 is 8.4%. For ages 45-64, 66.6% had no encounters, 31.7% had 1 or more in-person encounter, and 1.8% had 1 or more telehealth encounter. Telehealth encounters as a percentage of the total for 45-64 is 5.3%. For ages 65 and over, 56.9% had no encounters, 41.4% had 1 or more in-person encounter, and 1.6% had 1 or more telehealth encounter. Telehealth encounters as a percentage of the total for 65 and older is 3.8%.  

Greg Millett:	And when you take a look at telehealth, I mean, this is a paper from a very large sample. I think it was about 80,000 people. You see that telehealth is still not yet widely embraced, that when they looked at those individuals over the period of COVID who had an account, no encounter or greater than one person encounter, or just tele-healthcare encounter, you could see in the bright blue that vanishing, few people had a telehealth encounter, even among those populations, like younger populations who are more likely to embrace it, that only 8.4% had a telehealth encounter. It doesn't mean that it's not going to increase at some point, but right now it's still vanishingly small, next slide.

Slide Description:	Health Tech: Generalizable or Niche? Stable or Fleeting?

	Images of various health tech devices: a fitbit, apple watch, glasses that connect to an iPhone or Apple watch, and a Go2sleep Sleep Tracker Ring connected to a laptop with a doctor shown on the screen.

	Screenshot of a chart showing the percentage of the adult population who use, or are projected to use, smart wearable devices from 2020-2024. The data show for 2020, 24% or 62.2 million were users, in 2021 the number is 25.1% or 64.4 million, in 2022 25.9% or 68.1 million, in 2023 26.6% or 70.5 million and in 2024 it is projected to be 27.1% or 72.6 million.

	Source: eMarketer, September 2020. Methodology: Estimates are based on the analysis of survey and traffic data from research firms and regulatory agencies, sales projections, historical trends, company-specific data, and demographic and socioeconomic factors. 

Greg Millett:	The other point I wanted to make is that we don't know whether or not health tech is generalizable or niche, or whether this is stable or fleeting. And to the left, you can see all these different devices that we have out there for health tech telehealth being the first, but then there's all this wearable tech that has become very fashionable at some point, which is all incredibly expensive and really something that is going to be out of the pockets of many people who are financially less stable. But when you take a look at these wearable tech markets, you could see that over a period of time that they're not prognosticating that there's going to be a rapid increase in people who use the smart devices for wearable tech or even health tech.

	And it makes you wonder, well, what is the degree to which some of these health devices and whether these advances in tech are something that people are going to use. There's actually been papers that have shown that people lose interest in their new tech devices three months after receiving them. We've seen that with kids who've been giving laptops, we've seen that with people who use their Fitbits and study after study that after three months, you see a rapid decline in enthusiasm for using those devices. And we don't know whether or not we're going to see that rapid decline with telehealth, particularly with the zoom fatigue that we're seeing with many people in our society, next slide.

Slide Description:	Screenshots of two figures from an article titled “Feasibility of Separate Rooms for Home Isolation and Quarantine for COVID-19 in the United States,” Ashwini R. Sehgal, MD et al. Author, Article and Disclosure Information: https://doi.org/10.7326/M20-4331.

	Figure 2. Percentage of Multi-Persons U.S. Households Without Enough Bedrooms, Bathroom to Quarantine One Member, by Householder Race. American Indian or Alaska Native alone: 51.2, Pacific Islander alone: 51.0, Black alone: 50.4, Two or more races: 44.1, White alone: 36.1, Asian alone: 34.6.

Source: U.S. Census Bureau, American Housing Survey, 2019, sponsored by the Department of Housing and Urban Development. Enough bathrooms is defined by having at least two full bathrooms. Enough bedrooms is defined as a two- or three-person household having at least two bedrooms, and a household of four or more having enough bedrooms to allow one person to isolate in a bedroom without forcing three or more people in the household to share a remaining bedroom. Pacific Islander alone includes Native Hawaiian.

Figure 5. Percentage of U.S. Households Without Full Kitchen, Laundry, by Householder Race. Black alone: 26.8, American Indian or Alaska Native alone: 24.3, Pacific Islander alone: 24.0, Two or more races: 22.0, Asian alone: 20.1, White alone: 13.5.

Source: U.S. Census Bureau, American Housing Survey, 2019, sponsored by the Department of Housing and Urban Development. A full kitchen is not shared with other households, and has a kitchen sink, burners, a cook stove or a microwave oven; and a refrigerator. Laundry is both a washer and a dryer, neither of which is shared with other households. Pacific Islander alone includes Native Hawaiian.

Greg Millett:	And then last, I wanted to talk about some of the issues that we have with the nation that we have here, there's an Annals of internal medicine paper that looked at feasibility of addressing COVID for many populations in the US and they basically found that many Americans don't have access to multi-person household for quarantining, and particularly among racial, ethnic minorities, they don't have access to that. Many of these households also don't have access to a full kitchen or laundry by race or ethnicity. I mean, this is life in 2020, when we see from the census, next slide. 

Slide Description:	Screenshot of an article titled “More than 2 million Americans don’t have running water, basic plumbing” by Meera Jagannathan, Marketwatch from November 20, 2019. Photo of a person carrying a sign that says “Water is a human right.” Caption: People gather in front of a church before participating in a national mile-long march to highlight the push for clean water in Flint.

	Down the Tubes: U.S. map showing the percentages by state where people don’t have basic indoor plumbing. Alaska had the highest percentage at 3.8, followed by Arizona, New Mexico, Idaho, West Virginia and Maine. Those states have between .52 and 1.32 percent without basic indoor plumbing. States with percentages between .36 and .52 are Washington, Oregon, California, Hawaii, Montana, Wyoming, North and South Dakota, Kansas, Oklahoma, Texas, Missouri, Arkansas, Louisiana, Wisconsin, Indiana, Kentucky, Tennessee, Mississippi, Ohio, Pennsylvania, South Carolina, Georgia, New York, Vermont, Massachusetts, Delaware, New Hampshire, and Rhode Island. Florida had the lowest percentage (between .2 and .28). The remaining states fall between .28 and .36%.

Greg Millett:	And then more than 2 million Americans don't even have access to running water in 2020 and 2021 with Native Americans, 19 times more likely to lack indoor plumbing than their white counterparts, putting them among the worst of any group in African-Americans and Latin mixed households, lack indoor plumbing at almost twice the rate of white households. And then there's a map right there to the right hand side, where you could see those States where there's a greater percentage of people who don't even have basic indoor plumbing. Next slide.

Slide Description:	Screenshot of an NPR article titled “31 Percent Of U.S. Households Have Trouble Paying Energy Bills.” Photo of a light bulb made of coins (credit: Ponsulak Kunsub/Getty Images/EyeEm). Caption: According to the latest results from the Energy Information Administration, nearly a third of households in the United States have reported trouble paying their energy bills.

	“Households can spend more than 20 percent of their total income on their electricity needs,” George Koutitas, CEO and co-founder of Gridmates, a crowfunding platform told NPR.”

	“A 2016 study by the American Council for an Energy-Efficient Economy and Energy Efficiency for All found that African-American and Latino households ‘paid more for utilities per square foot than the average household.’ Housing for the low income also tended to be less energy efficient...”

Greg Millett:	And then there's also data showing that 31% of US households have trouble paying their basic energy bills so that households can spend as much as 20% of their total income on their electricity needs. And there was a study from 2016 that found that African-Americans and Latino households paid more for their utilities per square foot than the average household. And that housing for low income individuals also tended to be less energy efficient. So what does this all mean as we move towards telehealth, as we move towards electricity, as we move towards people who don't necessarily have privacy in their own households, to be able to take some of these visits? We have to deal with the country that we have, and the country that we have, unfortunately, is still riddled with inequities.

Leandro Mena:	So thank you, Jane and Greg for your thoughtful arguments. As we plan on moving forward with implementation of remote health as a tool to improve access to [inaudible 02:27:09] health services, it is evident that we have to give a careful consideration to many aspects of why, the what, the how, and for who. So Greg, [inaudible 02:27:22] deepening the divide between those who have access and those who don't, this concludes our debate and Patrick Sullivan will lead the next session, the panel session on industry perspectives. Thank you.

Title Slide:	Panel Session: Industry Perspectives

	Organizer: Patrick Sullivan, DVM, PhD

	Panelists:Rick GalliNick MalhommeJames York

Patrick Sullivan:	Good afternoon, everyone. And I see our panelists have, have joined, which is great. It's my privilege to get to moderate a panel dealing with industry perspectives and similar to the format of the other panels that we've had, I'm going to just present one slide that gives us an overall framework. And then we have three fantastic people who have experienced in different aspects of industry and are going to help us to consider some of the issues.

Slide description:	Remote Health System: Issues for Industry

	Determinants

· Business considerations

· Test offerings — breadth

· Support functions – shipping

· Insurance billing

· Regulatory requirements

· Reporting requirements

· Stat-specific requirements

· Payer expectation

· Reimbursement

· Specimen sufficiency

· Need for improved collection procedures

· Technical solutions to reduce request volumes

· Role of providers

· Individual providers versus consulting networks

· Assuring follow up care

· Assuring counseling services where needed

· Linkage to healthcare systems

· Home tests vs laboratory-based testing

· Linkage to public health systems

· Client perception and willingness

· Government healthcare budgets/budget cuts/need for govt-supported scaling

· Need for better data aggregation for disseminated testing approaches

	Approaches

· At-home self testing

· Self-directed self-collection

· Clinician ordered self-collection

· Public-health funding of web-based programs

· Integration with mobile apps

· Use of subscription services

· Types of testing

· Diagnostic

· Screening

· Test of Cure

· Medication Adherence

	Consequences

· Improved services for people in remote areas

· Achieving scale to decrease costs and price

· Reducing QNS specimens

· Improving timelines for accession, testing and reporting

· Reducing billing cycles and disallowed claims

· Increasing frequency of indicated screening tests

· Earlier diagnosis and treatment

· Integration with public health systems for surveillance and followup

· Translation of research to practice

· Growing needs for data aggregation with new testing methods

Patrick Sullivan:	So I'll introduce the panelists as we get to them, but if we're going to start with one opening slide. Yeah. So I sort of tried to use the same framework that we used at the beginning of the meeting and it really deals with determinants approaches and consequences. And so here, the determinants are really more specific to an industry perspective. And I want to start out by saying, we're going to be talking both about sort of self collect tests in which specimens are collected by clients and mailed in for testing, but we'll also have the perspective of at home testing, which I think introduces some different kind of issues for industry as it has from a regulatory sense and in the other ways that we've talked about.

	But at a high level, I think this conversation should bring in more business considerations, including the types of tests, the breadth of test offering that we want to be able to support may touch on regulatory requirements. There are issues with specimen sufficiency and what the costs and impact on programs are of specimen sufficiency and the need for improved collection procedures. The interface with providers, both from the point of the patients and from the laboratories' linkage to healthcare systems and how that may differ for home tests, linkage to public health systems. And then in a broad sense, government health care budgets, budget constraints, and the idea that scaling these services really will require investment from government. And finally, how do we get data out of these systems, especially for self testing and how do we better aggregate data for these disseminated testing approaches?

	Our discussion will span a number of sort of different approaches, including at-home self testing, self-directed self-collection, condition ordered self-direction, public health funding of web-based programs, integration with mobile apps, subscription services, and also keeping in mind that we have this range from sort of screening to diagnostic testing, text of cure, or potentially medication adherence. And I won't go through all the consequences, but we've really been talking about them over the whole two days, which is greater reach, greater convenience, more choices, potentially more frequency of screening and earlier diagnosis and treatment. So with that as a framework, I'll briefly introduce our three panelists and then we'll kick off our discussion.

	So we have with us Nick Malhomme, who began his extensive career in research and diagnostic laboratory sciences with the Ontario Ministry of Health and the Public Health Laboratory in Toronto, and since then has really worked in a variety of capacities with the Ontario HIV Treatment Network, with the BC Center for Excellence in HIV AIDS and Biomedical Laboratories and he's currently working with the REACH 3.0 program at St Michael's Hospital in Toronto, and as the director of testing and clinical trials implementation. Nick Malhomme is the international development director at Prevent Techs. Prevent Techs runs over 150 remote testing programs in the UK and have launched services on a global basis. Before joining Prevent Techs, Nick was the CEO of a UK tele-health business and managed business units in the UK, Brazil and India for Optum, which is part of United Health Group.

	Nick is located in central France, and we all feel bad, Nick, that you have to enjoy that French culture and food. And then James York is the head of sales and business development for Molecular Testing Labs. You've heard MTL mentioned by a number of the presenters throughout the couple of days here. MTL's mission is to provide accessible laboratory solutions through a culture of constant innovation with price and scale in mind.

	And they really have worked on developing logistics and specimen collection methods that open access to medical testing in light of the last discussion, where there may be a geographic, financial or stigma barriers creating gaps in care. So welcome to our panelists. And I have some quick questions to get sort of a span of some of the things you're working on and then we'll delve into some questions that may be addressed to the whole group, but Nick, I'll start out with you and you have this view that may compliment some of what we've been hearing about in the last two days, which is a real handle on what the situation is with remote testing in Europe. So could you just give us a quick idea of how these kinds of tools are being used for HIV and STI programs in Europe?

Nick Malhomme:	Absolutely. Patrick. So there are countries that are very advanced in terms of remote testing and have been for a very long time. So in the UK remote testing, for example, has been around since the early 2000s. And for example, the sexual health London program, which is the largest publicly funded remote testing program issued it's 1 millionth kit last week. So in terms of maturity, very, very strong, similar for Sweden as well, where there are a number of public programs and then everywhere else, tends to be very much in development.

	So you see a few scattered pilots across Europe. There's been a pilot focusing on the MSM population in France in 2018, which the French public health body are looking to extend this year. They've been small initiatives during the COVID pandemic in Spain, in Catalonia, but beyond that very, very little. And then you also have pockets in Europe where you've got far right wing governments who are blocking sexual health as a whole, and anything around testing, treatment, STI clinics coming under a lot of pressure in terms of budget. So certainly places like Poland and Hungary as well. So to be honest with you, it goes from the sub-line right through to the ridiculous. So a lot of work still to be done in Europe, although there are pockets of excellence.

Patrick Sullivan:	Great. Thanks Nick. I have some follow-ups, but I'll come back to you. Rick, I want to move to you next and you really have multiple perspectives here, but I'm interested in the perspective around HIV self testing devices, again, thinking about the industry perspective, which is, how does industry navigate introducing self-testing devices and what are the functions of regional or national sort of health authorities that either enable that or make that harder? So what is the play? I mean, part of what we're trying to get at here is how the different partners can facilitate a broad uptake of these tools. So specifically thinking about HIV self testing devices, what's that role of the national governments and policies to help or hinder?

Rick Galli:	Yeah, well, taking the Canadian perspective first off, self-testing is entirely new in Canada up until recently. In fact, the first HIV self test was approved in November of 2020. So there really is no precedent here. Self testing is now breaking entirely new ground. And with that, there's a lot of challenges, particularly from the perspective of industry, one of the main, or one of the important challenges is just in post-market surveillance of HIV testing implementation. How is that going to work in an environment where the individuals are now self-testing themselves and linkage to care needs to be built along those same lines. And so, this challenge in turn makes it difficult to learn about successes and potential gaps in rolling out new programs centered around reaching the end diagnosed through self testing. It's never been done before, at least up here.

	So being able to collect aggregated data potentially through the use of technology, such as mobile apps or telehealth platforms in a post implementation period can in turn inform policy. And these policies around self-testing are yet to be developed, but having this access to aggregated data in a post-market situation can certainly help inform these policies and lead to sustainable programs. In other words, this is like real life mirroring research efforts. And so these are what we're facing in the program I'm working with now in bringing self-testing into broad scale reality in the country. It's not just about access to the test, but it's about linkage to care. And then the successes and the gaps that we're hopefully filling through that in turn are going to help industry with a sustainable program to be able to keep self test supply going in a sustainable fashion.

	So we're hoping if I could borrow a line from one of my favorite old movies called field of dreams, if you build it, they will come. If you build a program around self testing, that includes linkage to care through the use of technology, they would be not only the individuals who are seeking self-testing and availing availing themselves of the program, but also members of government and policy that can hopefully build new programs around the successes through these new programs.

Patrick Sullivan:	Thanks, Rick. I want to reflect back and just maybe reframe a couple things that I heard you say that I think is important for government to think about. And one is that, we're just reminded of how much we've come to rely on high quality surveillance data and aggregated data that guide programs, evaluate programs. And so, these programs of surveillance and programmatic feedback, which are sort of part of the bread and butter of what government does, when we come to a situation where we suddenly don't have that view to what's happening, it makes us realize how critical those mechanisms are. But the other is that, if the industry is working on an innovative product or approach to allow this self testing, that the governmental leadership in terms of the guidelines that helps support the responsible use of that.

	And I think that might extend to self-collection approaches as well, but there is this interdependence on government in terms of the need for guidelines as new technologies emerge. And so how we sync that up so there's not a gap between the availability of the product and the public health guidelines that would filter through to providers. So I think those are incredibly important points about how symbiotic we are and how much we rely on the innovation from industry in that sort of surveillance and guidelines from government.

	All right, James, you've been working for a long time on this area of self collected, Rick was talking about self-testing, but in the area of self collected diagnostics, and thinking about your experience in the US, what are the barriers and facilitators to adopting these tests, these just by way of linkage, I want to sort of link back to what was talked about earlier in terms of laboratory developed tests and sort of increasing the options for self collect, but what have been the barriers and facilitators to the adoption and utilization of these tests in your experience?

James York:	Yeah. That's a big question, Patrick. And so it's going to take me just a minute to get through this. I think the first thing I want to frame this with a little bit of perspective, because we are talking about, and in our case, we're talking about testing that's not occurring otherwise, right? So I think the key facilitators here are just the increase in STD rates that we've seen. We have better testing available, but we're not really utilizing that in innovative ways. And so subsequently, we've seen a decrease in screening. And then I think that just the facilitators are the barriers. Like we've talked about the barriers being social stigma, or financial or geographic barriers. Those are also facilitators to the need to patient collected samples. I kind of, I bullet point these things out of what facilitators are. I look at technology right now being a very big facilitator.

	We've seen the need to be a lab, but also to be a digital platform at the same time. And so our ability to integrate via API or EMRs or remote ordering interfaces has become very important to our practice. And then just the ability to create secure HIPAA compliant portals for patients to retrieve results isn't a facilitator because we have that technology now. I look at feasibility as being a big facilitator. I know that you have personally published with the Emory team, several papers on feasibility of collection or patient willingness to collect. Charlotte Abydos gave us some good information yesterday about what are her experiences with feasibility. From a lab perspective, we've run over 1 billion assays, it's a pretty big number that were all on patient collected samples. And our rejection rate to this point is that less than 2%, it hovers about 1.9% and that's for any rejection reason, that means quantity, not sufficient, to the patient failed to put two patient identifiers on the sample because we're a cap accredited lab.

	That's a requirement for us to run the sample. Out of that, over 1 million assays run and reported, we've only had eight events reported to us as adversity advance. I think that's important data to understand the feasibility of collection here. In terms of validations, you brought up validations, the importance here is having broad list of targets and assays validated so that we can really capture all of the indications. It's also important to understand that the validations that we are performing are all done on FDA cleared devices, either 510K or PMA cleared assays.

	And then really what we're doing is taking validations that have historically been performed in an R and D lab. And we are scaling that for commercial use. So I think we can easily rely on the publications there to show that there's no loss of sensitivity. Price yesterday was mentioned as a barrier. I think that it's potentially a facilitator that we need to think about as a lab. The two factors that dictate our price the most is our overhead and it's our cost of consumables. So the argument here for us is, as we increase volume, we can decrease price. And that's really important to us to just get broad access to the testing. And then the last facilitator, we've had this conversation going on about telemedicine is here. Most medical decisions are based off of diagnostics. Where's the bridge for a telemedicine visit to getting a diagnostic lab?

	And how do you bridge that gap that exists right now because if you ask patients to have a remote healthcare encounter, but then ask them to go to a draw site for their diagnostic needs, that's a problem. And then with the emergence of physician networks that we've seen in this space, it gives us the capability to get authorized provider orders, to establish patient and provider relationships in a very quick way. It gives us a good way to pass on detected results and linkage to care, which we've identified as being very important. I want to speak very fast. I don't have much more time there, but the barriers, I'm onto the barriers here, we need clear direction, policy and procedure for how testing should be done. Again, I'm going to point out if we're focused on supplementing testing, that's not occurring or not replacing in-person care, this is new territory.

	So having clear policy for how we do that is important. There needs to be a clear distinction of budgets. So from my personal experience, this is where the breakdown occurs when we work with health departments or departments of health. So the clinicians are eager. They want to create a remote testing program. The business people ultimately get involved after we're contracted, after we're onboarded and registered, and then they don't have a good idea of how they're allowed to spend the money that they have. And so we get breakdown where we see a stall happening at the implementation point. And then the third and final barrier that I see is just general misalignment. We had discussions yesterday that had differing opinions on feasibility of collection. I think we could easily get alignment on that point. There seems to be a notion that we're putting patients at risk when they're self collecting.that's certainly not the intention, but if it is, or if it's even perceived to be the intention, I think that we need to address that.

	We need to be able to address that and come together on that point with how to make it the most safe, the most reproducible and accurate. And then the last thing I want to say is, where's it most beneficial for is an answer we have to come up with. So in the four categories of customers that we have, we have CFRs. So we're supporting research for most of the CFRs around the country on [inaudible 02:47:12] testing. What they are researching is demographics and patient populations that need self collecting. The most, because we see this documented distrust of the healthcare system, or just the barriers that we've talked to, our other three categories are 340B pharmacies. There's a financial driver there for getting the testing, online distributors, arguably we're providing testing to people that can afford healthcare. And then there's this fourth category of health departments and departments of health where they represent right now, less than 1% of our overall volume.

	And so arguably what I'm saying is, the research that you and others are doing is not that in the real world that's not meeting the cohorts of those studies. It's not meeting them in the real world. And I think that's something we need to solve for, you already said it. We need government intervention to address all of these questions, to promote scale and promote the uptake of testing. So I think we witnessed it with COVID. We've seen what happens when there's no cost testing to patients. There's brought uptake, and so something in that vein would be important here.

Patrick Sullivan:	Thanks. Nick, I want to bounce off of James's comments back to you and really bring this question back, because what James is saying is that the public health market is quite a small proportion of those mechanisms need to be in place. So I guess my question is in terms of the experience of the NHS trusts and local authorities, which are still local public health agencies, but to my understanding can contract for these services sort of more centrally.

	So the two questions are like, what is the experience of having that kind of mechanism in place with respect to what James is saying, but also how big, James mentioned one of the drivers of cost is scale. How important is that scale in sort of achieving feasible, large-scale testing from the industry side. So the two questions are the value of a mechanism, and you might just want to say a bit about that since people may not be familiar to facilitate those relationships with the deciders of the public health policies, can those policies for screening vary from jurisdiction to jurisdiction and how important a driver is the volume in your experience?

Nick Malhomme:	Yeah. Thank you. In terms of the jurisdictions, there are similarities. It's a very different healthcare system to the US. It's a publicly funded healthcare system, publicly funded through taxation, but we do have around 200 NHS trust and local authorities. Each of which are responsible for health care in their own area. So there is not one contracting party. You will have to pitch and work with different healthcare bodies. The services may vary greatly. Some will provide remote testing through a third-party provider, such as ourselves. Most of them do. You have some that will do it themselves and develop their own programs and their own communication around remote testing. And you've got some that are still reluctant to move forward. Albeit, you can probably count them on one hand now in the UK.

	So the public bodies, albeit very different have grasped the concept of remote testing and pretty much 90%, 95% are doing it today. In terms of scale, it is important. It's not something that can't be done without scale. We started out, we had one chlamydia program in a region in the South of England, Cornwall, which is quite rural and the program was profitable. It saved money. It ticked all the right boxes. Obviously, as you scale up, it gets easier and easier.

	There were really two game changes for Preventext. One was the two years ago we built our own land and obviously having a fully integrated process, as James said, linking in the technology, the APIs with the lab, and then being in full control of the process. The second piece was we tended and won the sexual health London program, which I said earlier is the largest publicly funded program in the world. So we've now put around 4 million tests or self sampling, all focused on STI or our lab only deals with STIs, which again helps on the volume question. We've put about 4 million samples through. So the scale is very helpful now, but it wasn't as if we had to wait 13 years to get to that scale. It was profitable and certainly worth doing. And the more you do the easier it gets.

Patrick Sullivan:	So I want to carry this theme through, I'm going to ask Rick, and then we'll come back to James, but basically James's statement that said the MTL is supporting testing, that wouldn't happen otherwise. I wonder from a public health and I think that's true in the US context and for a lot of the research and programs, but I would say in the UK, there might be a different perspective, which is that, for example, to my understanding, clients for what we would call STI clinics, if they're asymptomatic may actually be dispensed in at-home collection kit from the clinic. So it may actually be taking some volume out of clinic. So I guess I'll just put this to each of you. Should our goal be to test people who wouldn't otherwise test or should it be a mix of replacing some clinic-based testing in addition to reaching new people and what are those opportunities? So I'll let Rick have the first stab at that.

Rick Galli:	Yeah, thanks. So, Patrick, that's a good question. I think if I can relate to the program that we're about to launch next week in Canada, I'm ready, it's called I'm ready to know. It's going to be a large scale self-testing program distributing up to 50,000 HIV self tests across the country, over a one-year period for individuals who may want to self test on their own, but also includes a tele-health platform for connection to peer navigators. This was developed in partnership with industry in partnership with academia and it formed a unique partnership to be able to blend together stakeholders to really develop a holistic approach to bringing self-testing into reality. It's designed to reach the undiagnosed living with HIV.

	So to your question about whether it's looking for new individuals or perhaps, an adjunct to facility-based testing, it's a bit of both, in Canada, we know, and I think it's similar to the US, there is a significant portion of individuals, of population living with HIV that are unaware. We've been testing for HIV for almost 40 years in both countries. Yet there's still this significant gap in reaching certain populations and undiagnosed. So bringing these types of innovative new programs that combined self testing or home testing with tele-health platforms with mobile technology and websites. We hope is going to bridge that gap using the concepts of implementation science, for example, where you take what you know translated into what you do and hopefully you can bridge that gap or eliminate it.

Patrick Sullivan:	Great. So our time has gone incredibly fast. We have time for each of you to have about a minute. I'm just going to ask of everything that we've talked about. You have an audience here that has a lot of CDC folks, a lot of local health department folks, if you could propose one thing that you think would help move forward, the development of this capacity and the impact from an industry point of view, what one message would you want to share back with this broad group of health department folks, policy makers, physicians, and I'm going to flip a coin since it's a short notice question and let's see James, it came up heads. It came up, James, what's your one wrap-up point about what we can do as a community to help get more out of it this tool?

James York:	Two words, remove the, three words, remove the barriers, create the policy. We can do that together. We're very interested in collaboration and partnership and anybody that wants to join in. Create clear and distinct budgets and just let people know how they're allowed to spend their money so that they can avoid any fear or risk of audits or recoupment on how they spend that money.

Patrick Sullivan:	Right. Thanks, Rick. What one thing can government do to help expand the impact of these tools from an industry perspective?

Rick Galli:	Yeah. I'm going to take a little a segment from the previous session, the debate session, and take the approach that tele-health is here to stay.I believe, or we believe that it does increase health equity, and that's the approach that we're certainly taking. We believe that this should gain widespread government support to be able to continue with telehealth delivery services, even in the post COVID era, because we believe it's going to work. So that would certainly be, I guess, the one single message that I'd like to expand on.

Patrick Sullivan:	Great. And Nick, you get the last word.

Nick Malhomme:	Thank you. So, two words, collaboration and communication. So collaboration, sharing data, making the processes as transparent as possible, allowing people to see the labs and ensuring that people really understand the populations that they can touch to new populations will be called channel shifts. So supporting the clinics to focus on symptomatic people and taking the symptomatic people out and working with the health bodies to ensure good treatment sharing of information and data around the social determinants around inequality and embracing down inequalities, and then communication to ensure that people know, understand, breakdown stigma for the user. We've got an 80% return rate in the UK. So just ensuring that people feel comfortable to all the kids. It becomes something that is second nature in terms of integrating within the health care system.

Patrick Sullivan:	Great. So we are at time, I want to, on behalf of all the folks watching with their microphones muted and their cameras turned off, I'll just on behalf of them. Thank the three of you for making time to join us. And I think it's, and thanks to Seville in terms of the organization for having a voice for industry to be part of this discussion, because clearly industry is a critical part of building the infrastructure. If we want to do this at scale, we need to do it with you guys. So thank you all for being part of this panel. And I will turn things back to Sevgi.

Title Slide:	Closing Session: 

	Where Do We Go from Here? — Next StepsSevgi O. Aral, PhD, MA, MS

	The Role of NCSD in Remote HealthDavid C. Harvey

Sevgi Aral:	Thank you very much, Patrick. Yeah, that was a fantastic panel discussion. I am Sevgi Aral and I am the associate director for science and the division of STD prevention. And I have been very lucky and happy and being involved in the organization of this meeting. I had a lot of help from some very smart people, and I think it turned out really nice. I'm that it's coming to an end, but if I could have the slide, Patricia, maybe I can talk a little bit about where we go from here. Thank you.

Slide description:	Remote Health 2021

	Next Steps

1. This meeting was a first step in a multi year effort

2. Future meetings

a. More narrowly focused

b. Shorter

c. Organized with your input

d. Quarterly

3. Future publications

a. Papers/special issues

b. Based on this meeting

c. Based on future meetings

d. Organized with your input

e. Prepared with your participation

4. Background materials

5. Please write to me/call me soa1@cdc.gov

6. All in collaboration with our partner NCSD

Sevgi Aral:	So next steps, unfortunately, I'm going to say, we're not sure about the specifics of the next step and a lot will depend on you. But the one thing we know about the next steps is as Raul said, when opening the meeting. This meeting, we have always imagined to be a first step in a multi-year effort, looking at the role of remote health or all kinds of health and making STD HIV prevention better. So there will be more things we do, and hopefully we are going to do them together with you because that's what's needed. Now in the chat I had and in emails I heard people say, are these slides going to be available to people? Every single session in this meeting has been recorded and it will be made available to everybody openly.

	I'm not sure exactly how many days it will take for it to become available. I'm sure there will be a slight lag between now and when they are available, but all of the sessions will be available. Secondly, we are planning to do future meetings. I'm not sure we will have another two-day, three-day meeting, but we are going to have more narrowly focused meetings, shorter meetings, which will be organized with your input. Somebody asked me the other day, with what frequency do you think you will have these meetings? I guessed quarterly. Then I discussed with the acting division director, Raul Ferromagnet. And he said, yeah, quarterly makes sense. So for now we're saying quarterly, if things evolve differently, we will rethink about it. But what I need to say here is we need to hear from you. Please write to me, call me.

	We want to know what meetings should be prioritized. What meetings should we have first? Which more specific narrowly focused subject matter should we go to first? So we need input. Please keep it coming. We will respond to that by organizing perhaps quarterly, more narrowly focused, more specific meetings on the subject matters. We have looked back as you know. We took a very high level, look at remote health during these two days. So we need to go deeper into subject matter and look at more specifics. Secondly, future publications, we totally think we need publications. We need to make these views accessible and whatever these data are accessible to everybody so that we can be fueling the development and growth of the field. So we'll be working to publish papers. We will be working to publish special issues. Again, first we will publish papers on special issues based on this meeting.

	Then we will look at further publications based on future meetings, but all of this will have to be organized again with your input and prepared with your participation. So please let's collaborate. Let's make this a big push in the direction we all want. Now I had asked for background materials from all of the speakers and organizers. We didn't make those available to you because we received a very small volume of background materials. We are still looking to prepare this collection so that we can make it available to all who are interested. Towards that end, I will be grateful if you send me background materials. If you can clearly label it for remote health materials, we will try to put them together, organize them and share with everybody. Again, I am going to request that you communicate with me. My email address is here.

	Please write to me. You can also call me. We can schedule a phone conference. Hi, I'm really interested in collecting all of the input from all people who think about this subject. That's how we are going to come up with the best results. I have to thank everybody who has helped me, particularly people who have organized the panel and discussion sessions, particularly people who have basically taught me everything I have learned about remote health. You know who you are. Thank you so very much. I'm going to come to you again so that you can teach me a little bit more because I will need that.

	Now we are going to do all of this and I'm sure we're going to need collaboration with our partner national center coordinating. I'm sorry, MCFC. Now I'm going to block on this. Have a senior moment. So they are our partner in all of this, and they have been working on remote health for an extended period of time and they plan further work on remote health, into the future to represent the NCST view. We have David Harvey with us, and I'm going to ask David to please share with us the MCSP view before we close the BP.

David Harvey:	What I want to do is to walk you through a few things. I am going to describe for you some factors of macro level policy that describes where our field is out at the moment. The work that we did this past year to document the impact of COVID on our field, that has led to some real innovations in tele-health. We'll talk a little bit about the issues on the incredible news that we're facing right now around a massive funding expansion. That has been announced to expand the DIS workforce and implications for remote health. Then I'm going to wrap it up and I'm going to do all of this in about six minutes, because I've lost some time. You would think after a year and a half, I would learn how to work, Zoom and screen sharing. But I apologize for that. Obviously I have not.

	I want to pick up on a couple of themes, actually, that James York from MTL described, removing barriers, creating policy, creating budgets and clarification for how dollars can be spent. With those things in mind, it's really a good segue into talking about the issues that I wanted to cover very briefly today. As many of you may know, we're paying attention to the materials and CST issues. You know, our organization, our entire staff and team went into overdrive from the earliest days of the pandemic. From that first moment that Tony Pauci started talking about contact tracing in one of his infamous press conferences. When we all had an aha moment, where is contact tracing historically been based in the public health system in the United States? The STD field for decades in the form of various terms for the workforce called DIS have long gone contact tracing and outbreak response.

	So we realized right away that not only was COVID going to have a profound impact on our field. It was likely to drive innovations. We knew that the impact would be profound because from the earliest weeks of the pandemic, almost the entire STD workforce in America, within health departments in States and cities got redeployed to a COVID response. We set about documenting that in various reports issued by NCSD. We took to the airwaves to tell the cautionary tale of the story of our field with a goal of influencing some of the issues that James York mentioned, which is money, regulatory reform policy barriers. How could we use this moment, this tragic moment in public health history in the United States to tell a story about what was also happening in an out of control, another epidemic, which was of course STIs. So the reports that we issued very clearly demonstrated that there was a mass disruption. Mass disruption to testing, mass disruption to sexual health services, mass disruption to this surveillance system. Sexual health clinics for the most part closed down, started tele health.

	Right away, we got sucked into helping to our members across the country exchange really important information about innovations, how to implement these programs. All of this was approached from an equity perspective. I loved hearing the debate and the sessions today about what exactly the data shows about who we can reach through these strategies. NCSD comes down on the equity side of the house in terms of thinking about how we use these new tools to reach communities that we have not traditionally reached in the past. What we're seeing through some of the collaborations and partnerships that have over this past year is a very strong, local evidence that we are reaching people that normally would not be in the system. So that is something obviously that needs to be researched further as we go forward. So also we did what we did this past year was to focus a lot on the disease intervention specialist workforce. The media popularly coined this as contact tracers.

	We took what we could get, but we always pointed out that this is a workforce that comes from communities that we're trying to reach and serve. It's a particularly important backbone of the public health system used to reach people in need. That this is not just about contact tracing, but it is also about navigating people to testing and care and vaccines and the whole nine yards. This is also a workforce that is central to our ability to conduct outbreak response and investigations. So the teams that CDC has sent out to investigate COVID outbreaks and other outbreaks, you always find a DIS a member of that team. It is the human touch component of the public health workforce designed to reach real people and address their real needs. From there, the innovations were fast and furious, and we're still taking stock of that. We tried and failed for COVID relief bills to get mentioned in there of this workforce, knowing that there was a couple of goals in mind. One, more recent stroke resources to our field were desperately needed. Two, the chance to tell the DIS story. Three, the chance to win new resources, to modernize and update this workforce.Four, providing more resources, resources that were desperately needed for public health infrastructure, including our nation's ability to respond to an out of control STI raise.

	As all of you know, we are in the sixth year running a record numbers of STIs in the United States. At the core of everything we are trying to do in remote health is a resource question. So NCSD from day one took on this issue of figuring out. How was it we were going to manage to put more resources into this field. So partnering with many of you on the phone and in this webinar today, partnering with CDC and specifically the STD division of CDC. I think we made the case pretty well. So last week, was it this last week, the announcement was made as part of the American Recovery Act of 2021. That 1.13 billion new dollars would be allocated out of a larger pot of 7 billion provided to build up the public health workforce in the US. The 1.13 billion will be allocated specifically to the STD version of CDC, to states and cities who are grantees under the acronym that we call PEACHED, which is the main cooperative agreement that supports STI prevention and surveillance, and just a little bit of clinical care services.

	So this is enormous news. It sidestepped some of this of the discussion that we heard earlier in this conference around how you manage policy and reimbursements to pay for many aspects of remote health. Not that we don't still have to do with the deal with those issues, we do. We will. It's a very important set of issues, but utilizing the discretionary funding mechanisms of Congress to provide special funding. These dollars will come to the field first for COVID relief to build up the DIS workforce, but also can be used quote unquote for other infectious diseases. As our CDC, friends and colleagues know today, the NOFA has not been issued yet. There is lots of news that's breaking and will be coming in the next week and a half and two weeks about this, I believe, but states have already received an allocation. This will be allocated over five years, which means a $200 million supplement to the existing funding to states and cities.

	So what I also want to comment on is the DIS workforce role in remote health. I don't have all the answers for that today, and we don't have time to get into that, but DIS play a critical role for reaching people, navigating them through the healthcare system. I think that self-collection home testing strategies using DIS as a workforce that can help reach people to educate them. To make these kits available to them is certainly a really important mechanism that we have to think about using. With the resources coming to help departments and cities, we also know that there's going to be flexibility in how some of these resources can be used. So off-setting other costs and supporting the work of DIS and all that the technology needs that they have, the training needs that they have means that they're all boats rising. All boats rise. There will be resources available to zero in on some aspects of how we support remote health.

	So NCSD, our role is going to be to continue push this along this special funding that is coming through the STD program at CDC. Our number one policy goal will be to ensure that these funds get added to the base program so that after five years the funding continues. We are turning on a dime. Once again, to retool the response of our organization, to serve our members, and we're going to do everything we can to help state health departments and cities apply for these funds, ensure that they take the funds and that they are spent in partnership with a community. That is where understanding the rules of how the dollars will flow will. All of you will be very keen to understand once that NOFA comes out. Once states and cities take steps to implement this new funding, our annual conference this year, STD engage will be entirely focused on this.

	We will suspend a normal conference and zero in on these issues along with work that we will do to take a very hard look and partner wherever possible with the Department of Health and Human Services on an implementation plan related to the first ever federal STI action plan. Again, remote health can and should be a major component of that plan. I think there's very important and good information in the NASEM study that was just released as well that Jeff Crowley was a part of and others on this call. So there is many exciting developments in our field right now and forward momentum around some of these developments. Last but not least, there's been a lot of comments, obviously on various platforms and efforts to get partnerships off the ground around self-collection home testing strategies. NCSD in the coming weeks, will launch a platform that we're calling My Sexual Health Labs. The central goal, and a very tough one to realize I might add, is to have a platform that states and cities can use to integrate with their public health surveillance efforts, which then in turn means that DIS and others get the information they need for followups, partner services, doing all of the things that our programs do across the country to reach people in need if they have a positive test result.

	But the first and foremost challenge we have been taking on is how can this system be better integrated? How can we provide options for states and cities to integrate into the core public health surveillance systems that they already have in place? Last but not least, I know this is going to make Charlotte Gates very happy, NCSD is going to take on an effort around FDA regulatory reform. We've already been looking in depth into this. It's a very complicated set of issues. Many people have already commented in this conference around these sets of issues. We will be taking this on. So much more to come in that area. With that, without even showing you my slides, that is most of what I wanted to comment on today to round out today's discussion. Seville, congratulations on this meeting. I think it's groundbreaking in some important ways. Now I think what we have to add to this discussion is some real resources that are coming to this field for the first time. Probably the largest amount of resource infusion into this field in our history, which can only benefit some of these new programmatic initiatives. So thank you very much.

Sevgi Aral:	Thank you, David. Thank you everybody. I think it was two days well-spent. Thanks to all of you. I'm almost sad that it's coming to an end, but we are at the end. Thank you.