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Rebekah Horowitz (she/her): Hello everyone.

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Rebekah Horowitz (she/her): This is Rebecca I apologize for any confusion that came from the start of this webinar somehow it transitioned it from my personal.

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Rebekah Horowitz (she/her): zoom link to a different one and I didn't realize it, so the speakers and I were all ready in the other room and then we realized that none of you are with us.

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Rebekah Horowitz (she/her): Thank you for joining us today.

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Rebekah Horowitz (she/her): i'm going to just give it one more minute, and then we will get started when I give another minute or two for folks to join, thank you.

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Rebekah Horowitz (she/her): All right, it is 203 Eastern time and people have stopped flying in through the Internet to join as participants and welcome everyone to this webinar 340 be basics and beyond, we are co hosting and NATO and nc sd we're really excited to come together to work on this um.

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Rebekah Horowitz (she/her): For those of you that don't know, I was at and cst before I came to NATO and started working on 340 be in that setting and have worked on it more since I came to NATO and so it's.

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Rebekah Horowitz (she/her): awesome to come together to do this joint webinar but mostly is going to lead or lean on the expertise that ncs D has on 340 be and continue to has been continuing to elevate.

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Rebekah Horowitz (she/her): 340 be as really relevant STDs and HIV programs so Thank you everyone for joining us thank you Aaron and stephanie.

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Rebekah Horowitz (she/her): Our agenda for the day is some basics around 340 be how it works and looking into health department eligibility health department utilization of 340 be registration and compliance.

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Rebekah Horowitz (she/her): Including the glossary of terms and addressing infectious diseases and then questions and opportunities for ta was going to do a little bit of setting up the stage.

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Rebekah Horowitz (she/her): So many health departments are experiencing flat or reduced or reducing funding.

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Rebekah Horowitz (she/her): And so, in nature's 2019 profile study of local health departments, we learned that in the years following the recession in 2009 to 2012.

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Rebekah Horowitz (she/her): Between 41% and 45% of local health departments reported lower budgets, compared to the previous fiscal year.

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Rebekah Horowitz (she/her): And these budget cuts have declined a bit since 2014 with only 15% of health departments reporting lower budgets relative to the previous fiscal year in 2019.

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Rebekah Horowitz (she/her): But best that it's been since 2008 but even worse health departments are not experiencing reduced budgets, they are generally experiencing flat funding.

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Rebekah Horowitz (she/her): or they're receiving a big influx of funding to work on something like say a global pandemic, but we can't really count on that funding to stay with us forever or to be applicable to all of our programs.

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Rebekah Horowitz (she/her): So, again looking at data, the majority of local health departments 52% so no increase in funds in 2019 and they expected 62% expected flat funding the next fiscal year that would be despite inflation, population growth and the increasing complexity of public health challenges.

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Rebekah Horowitz (she/her): Little did they know the increasing the complexity of public health challenges would be COPA.

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Rebekah Horowitz (she/her): So obviously.

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Rebekah Horowitz (she/her): Things are a little bit different than we thought they would be, we have received larger budgets as a result of.

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Rebekah Horowitz (she/her): But the assumption is the progress there will be short lived because of that funding, not necessarily being long term.

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Rebekah Horowitz (she/her): So that's where we are.

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Rebekah Horowitz (she/her): health departments must think about how to stretch their funding and so one option is to build third party payers, such as private insurance companies and medicaid and that's something that we know a lot of health departments are thinking about.

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Rebekah Horowitz (she/her): Another for his health departments to enroll in the 340 be drug pricing program which provides a dicks discount on the purchase of drugs.

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Rebekah Horowitz (she/her): And then, a third is that for the combination of the two is local health departments can bill and to be enrolled in the 340 be program and there, there could be additional potential for revenue through the combination of the two programs.

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Rebekah Horowitz (she/her): So our presenters for most of the webinar today will be stephanie Arnold pang senior director of policy and government relations at MC St National Coalition of STD directors.

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Rebekah Horowitz (she/her): As well as Aaron fratto, who was the public health consultant working on 340 feet with mcs D and i'm going to turn it over now to our presenters and dear friends from ncic stephanie and Aaron.

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Stephanie Arnold Pang: Thank you so much Rebecca and great to be with you all this afternoon or this morning, this was still morning in some places.

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Stephanie Arnold Pang: All right, let's roll on to the next slide because I don't have control rates Rebecca.

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Rebekah Horowitz (she/her): I don't think you do so i'm happy to okay.

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Stephanie Arnold Pang: Thank you.

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Rebekah Horowitz (she/her): pages move your little all of our little heads, but I can get to it okay there we go.

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Stephanie Arnold Pang: Alright, so we're going to start with general program overview and eligibility about 340 be and i'll say you know, we do have a Q amp a and a chat.

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Stephanie Arnold Pang: 340 be always leads to about one question one comment leads to about 17 separate questions on 340 be so.

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Stephanie Arnold Pang: If you have general questions put them in the Q amp a will try to take them as we go along, and we hopefully we'll have some time at the end, but also, obviously, will share all of our contact information so if we need follow up we're happy to do that as well alright next slide.

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Stephanie Arnold Pang: So what is 340 be.

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Stephanie Arnold Pang: it's a federal law that requires drug manufacturers to offer discounts on drugs to certain type of a safety net providers for outpatient use.

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Stephanie Arnold Pang: So 340 be might sound like like a little bit of golf gobbledygook if you've never really spent a lot of time with the Program.

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Stephanie Arnold Pang: It does refer to a specific section within the public health service act where the requirements are found.

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Stephanie Arnold Pang: And I want to emphasize that the discounters are the discounts are provided by drug manufacturers and are not funded by taxpayers, and I should say that this week beginning is kind of one on one is pretty general so we're going to try to cover a lot of.

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Stephanie Arnold Pang: 340 be levels of knowledge at once, so next slide.

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Stephanie Arnold Pang: So what 340 be is not is a grant so while Rebecca stated, which is obviously accurate that it could be a support for a revenue stream of of kind, it is not an ongoing grants that is automatic, it does not provide free medications it does not provide or.

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Stephanie Arnold Pang: Testing or laboratory support, and it is not for vaccines, because this program is for outpatient drugs only and obviously vaccines are provided at the time of service, so not considered an outpatient truck.

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Stephanie Arnold Pang: Next, please.

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Stephanie Arnold Pang: So we're thinking about the 340 be eligibility and who qualifies, and so we have provider eligibility.

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Stephanie Arnold Pang: Combined with patient eligibility and that allows three to be 340 be eligible so there's kind of there's you got to refer to discuss about provider eligibility, as well as a patient.

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Stephanie Arnold Pang: and make everything 340 be eligible, you don't have one or the other between between provider eligibility and patient eligibility, things are not you're not 340 be kosher and you will, is not eligible will continue next slide please.

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Stephanie Arnold Pang: So, first of all let's talk about which types of providers are eligible, so we have a.

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Stephanie Arnold Pang: large portion of eligibility regarding hospitals disproportionate share or dish hospital children's hospital hospitals freestanding cancer critical access hospitals.

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Stephanie Arnold Pang: And then there's a non hospital grantees a non hospital eligibility that we tend to refer to as the grantees.

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Stephanie Arnold Pang: The federal grantees have mostly herself, but also CDC grants so says fq HC is Ryan white providers title 10 family planning providers hemophilia clinics STD clinics also referred to a section 318 which we'll get to as well as TV clinics or section 317 next slide.

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Stephanie Arnold Pang: So in the 340 be statute refers to STD clinics or recipients of Section 318 months So what does that.

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Stephanie Arnold Pang: mean well section three teen is a section of the public health services act again that directly refers to the part of the public health services act that authorizes STD funding.

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Stephanie Arnold Pang: So this is a little screenshot of the Public Health Services Act section 318 so it's a regarding the control and and the prevention of sexually transmitted diseases.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: So historically we've understood 340 be eligibility to refer to STD clinics.

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Stephanie Arnold Pang: To be the grantees are the sub grantees of the DST dp, which is the division of STD prevention CDC the base STD grant, which is currently the STD peach.

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Stephanie Arnold Pang: grant lots of acronyms there but it's basically the base St Louis grant coming from the CDC.

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Stephanie Arnold Pang: About three years ago, or so redefined what they referred to as STD or 318 clicks to be any now any grantee or sub grantee of any CDC grant that uses section 318 that screenshot we saw previously and it's legislative authority.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: So what does three team legislative authority mean so every no photo that is sent out from the Federal Government we're talking about CDC grants in this in this webinar.

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Stephanie Arnold Pang: Has a statutory authority that permits the Federal Government to put out this funding.

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Stephanie Arnold Pang: So if you want to look at and make sure if the know Fo that you're getting funding under or interested in.

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Stephanie Arnold Pang: Getting funding under is a section three teen eligible grant you have to go back to the original Novo that comes out from the Federal Government CDC in this instance, and if they use section 318 so this, for example, is the.

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Stephanie Arnold Pang: The the STD piece grant so the basic current base STD grant from CDC which uses section three teen as its legislative authority, and so it is a section three teen 340 be eligible grant.

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Stephanie Arnold Pang: It doesn't matter what little letters are behind this and it says section three teen, it is a section three, it is a 340 be eligible grant.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: So we've discussed we've discussed the types of providers, so this, so this is the provider eligibility and the sexual in three teen as a number of different grants.

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Stephanie Arnold Pang: That uses section that uses the eligibility to allow it to become a 340 to be eligible grant So these are just.

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Stephanie Arnold Pang: a snapshot of a few grants that are most we think most applicable to local health departments so HIV integrated HIV surveillance and prevention programs the STD peach grant.

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Stephanie Arnold Pang: Ending the HIV epidemic and into and the viral hepatitis integrated surveillance and prevention fund so there's a lot of Section 318 grants, but these are most likely the top for that local health departments either have or are have access to the.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: So there's kind of three tiers for lack of a better word to provider eligibility first number one section 318 grants so First is the CDC which manages the section 318 grants.

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Stephanie Arnold Pang: At the at their level they then give out money going to the next level to the grantees who received federal funding authorized by section.

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Stephanie Arnold Pang: directly to get that money directly from hhs and CDC it's typically a State health department, a local health department or cvo depending on which the Novo and grantees have the ability to confer eligibility for 340 be to sub grid.

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Stephanie Arnold Pang: And the next level is a sub grantee they receive section three to pass through through federal funding from the grantee the next level up.

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Stephanie Arnold Pang: can be a local health department Community based organization or other provider, depending on the type of grant and the sub grantees cannot confer eligibility to other entities.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: So covered entities.

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Stephanie Arnold Pang: must have or just state that the 342 week program refers to the all of the clinics within within their program as covered entities.

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Stephanie Arnold Pang: So they must have a financial relationship with a qualifying section 318 program that is eligible for 340 be.

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Stephanie Arnold Pang: So you can't just say Oh well, I do STD prevention work that's not that doesn't get you there you need to have a direct financial relationship with with.

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Stephanie Arnold Pang: With a 340 be eligible grantee and and through either during direct financial support or receiving in kind contributions, and that will make you eligible for 340 be.

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Stephanie Arnold Pang: So you can get direct flight and direct financial support, which is pretty straightforward you get money from the grantee.

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Stephanie Arnold Pang: Or you receive income contributions and income contribution here at the bottom of the slide is the definition.

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Stephanie Arnold Pang: from her sense of what in kind contributions are most paid paid for number one by section three teen grant funds and they be may be in the form of real property.

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Stephanie Arnold Pang: equipment supplies or other services directly benefiting and specifically identifiable to the patient into the program or project so.

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Stephanie Arnold Pang: What is defined as in kind is typically beyond that any additional specificity is really left up to the to the grit T, but those are you know conversations with sub grantee or a local health department could have with the grant T is you know, do we qualify.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: So a few questions to be considering.

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Stephanie Arnold Pang: to determine if your local health department is eligible for 340 be number one do you receive section three teen support from your state health department.

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Stephanie Arnold Pang: Do you have contracts, do you have mo use you have support and staffing like does the state directly support a di es or a nurse practitioner other staff at your local health department those would all be eligible some services were eligible in kind contributions.

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Stephanie Arnold Pang: Or are you a direct recipient of Section 318, for example, a number of local health departments are directly funded through the ending the HIV epidemic funding from the federal government he grants are.

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Stephanie Arnold Pang: grants that are 340 be eligible, so if you are he directly funded jurisdiction, you are 340 be eligible, and you are the grantee at that point, so you don't have to get additional support there anyone else, if you will, but he grants, you are a 340 be eligible grantee and so.

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Stephanie Arnold Pang: Just thinking, how can you optimize your strategic alliances and your partnerships from from your local health department to other grantees particularly your state health department to further in this instance STD HIV or viral hepatitis work to make you 340 bl.

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Stephanie Arnold Pang: And with next slide and we'll turn it over to Aaron for the next section.

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Erin Fratto: Passing the virtual baton.

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Yes.

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Erin Fratto: awesome things definitely okay let's do the next slide Rebecca let's keep talking about some local health department considerations.

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Erin Fratto: The lots of local health departments and an STD clinics are providing clinical services, the 340 drug pricing program can really save a significant amount of money.

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Erin Fratto: The program like Rebecca said, can also be leveraged to generate revenue Those are two very important things in this fiscal.

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Erin Fratto: fiscally scarce environment save money, generate revenue, we often see STD clinics utilizing the three four TV program to save money on the treatments, they provide patients with.

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Erin Fratto: So that right there just saves them money and a budget line item if you're paying 10 cents for a medication that you weren't paying $1,000 for there's a significant amount of savings.

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Erin Fratto: it's it's also important to note that, once the patient definition is met any medication, that is clinically indicated during that visit, can be prescribed.

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Erin Fratto: So, for instance, if I met an STD clinic.

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Erin Fratto: And the provider also notice, as I have a skin infection or another medical issue that needs medication, they can take care of me, using the 340 be drug pricing program so again additional costs on additional medications can be saved.

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Erin Fratto: health departments also utilize 340 beat for prep viral hepatitis treatment or other infectious diseases and we're going to get into that more a little bit later on, but really just want you to start thinking.

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Erin Fratto: about your clinical operations that includes STD treatment syphilis elimination efforts prep expedited partner therapy, which is treatment for committee and gonorrhea.

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Erin Fratto: and any other medication that you're providing patients with in the sense of a STD clinic or an infectious disease clinic next slide.

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Erin Fratto: So really the two ways the money works is generating revenue or.

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Erin Fratto: Having a significant amount of savings, the 340 TB program provides the upfront savings by giving covered entities access to deeply discounted medications.

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Erin Fratto: But 340 TB program also allows covered entities to generate revenue if they have insured patients.

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Erin Fratto: This is done by dispensing 340 be priced medication and then billing insurance for that medication.

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Erin Fratto: For insurance Ben pays the retail or negotiated health plan price and that allows the covered entity to generate that revenue, that is their revenue they keep that revenue.

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Erin Fratto: there's no herself CDC or statutory regulation for program revenue or savings, but the program does need to reinvest the savings or revenue.

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Erin Fratto: into the services that are in line with the goals of the grant or the section 318 funding that is allowing 340 be access.

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Erin Fratto: So this reinvestment might look like increasing access to services getting a mobile unit up and going to provide services out in the Community serving more clients increasing services, improving the quality of services.

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Erin Fratto: That reinvestment needs to be tied to the scope of that brand that's giving eligibility also program savings and revenue should be.

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Erin Fratto: should be considered if you're entering into a contract mo you are other agreement with your state health department or a grantee that's providing 340 be eligibility if you're not the directly funded health department.

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Erin Fratto: Next slide.

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Erin Fratto: And this really highlights the cost savings that we've been talking about this let's put a finer point on it let's look at the cost difference between the treatment for media.

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Erin Fratto: And the treatment for syphilis is the throw my son you're going to save $135, on average, of course, prices fluctuate, but this is kind of an average and approximation of where you're at by selling.

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Erin Fratto: If you're not a 340 be covered entity, you might be paying 1200 dollars for a box of isilon 340 be prices 20 cents.

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Erin Fratto: So again, significant cost savings, not all medications are that drastic as by spillane that's my favorite to highlight just because you can see the discrepancy.

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Erin Fratto: But these these are savings in budgets that you can be having across the board $135 here $135 there that's going to add up, and again when you're looking at.

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Erin Fratto: more expensive medications that just by exelon viral hepatitis treatment other more exorbitantly priced medications you're going to have bigger savings.

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Erin Fratto: Next slide please.

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Erin Fratto: Alright let's talk about registering so we wrapped our mind around it for eligible, we followed stephanie guidance looking at section 318 and are nofollow we've talked to our grant administrators and our project officers next slide Rebecca.

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Erin Fratto: it's important to note that there's for annual recertification periods it's the first 15 days of every calendar quarter it doesn't matter just.

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Stephanie Arnold Pang: Registration you said recertification.

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Erin Fratto: Oh sorry registration yeah, we need to practice differentiating those to.

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Stephanie Arnold Pang: register on the simply sound very similar it's a quick it's a thing and three freebie took me a long time to get the difference, but they.

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Stephanie Arnold Pang: are different, I just want to make that note sorry there is.

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Erin Fratto: No i'm glad to interject it so before you recertified you have to register, because you cannot recertified if you're not registered Kate so registering so you're new to the program you're not participating yet let's get you registered.

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Erin Fratto: And registration happens, the first 15 days of every calendar quarter it doesn't matter if the day happens on the first is on the Saturday or Sunday it's not tied to business days it's the first and 15th regardless of what these those fall on.

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Erin Fratto: You need to have some information before you register, and that includes the grant number.

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Erin Fratto: And you might need to get Ahold of a grantee or your grant or, if you are a local health department not directly funded.

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Erin Fratto: And you also need to be aware that the registration is kind of held at goes to her suffer approval her so we'll loop back around and verify with the state level.

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Erin Fratto: grantee that you are in fact eligible for the 348 program so it's good and bad that it gives you this timeline because you know if you're overwhelmed today, and you and you think I have to register well you can't register.

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Erin Fratto: until April 1 now so now you've got three months, or you know, two and a half months to figure stuff out and then, once you register, you have another three months to figure even more stuff out.

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Erin Fratto: So there's this kind of her set implemented timeline and again good and bad because you can't save money immediately, but you have some time for bureaucratic processes.

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Erin Fratto: Ideally registration is done at the service level site each location should have its own unique 340 be ID and database entry you don't want to be vouching for another service site each service site should have their own 340 be ID and operate as their own entity.

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Erin Fratto: And if you want to click to the next slide Rebecca.

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Erin Fratto: Registration checklist you want to determine who you're authorizing official is.

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Erin Fratto: And we're going to talk a little bit more about authorizing officials and our recommendations about that, but you're authorizing official you need to know who, that is, you need to know who your primary contact will be.

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Erin Fratto: You also need to create an account in the office of pharmacy affairs information system and that were just disappeared off that slide sorry because I think it was hyperlinked and disappeared.

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Erin Fratto: And you need to know your no photo and your grant number, because those are both going to be required in the registration.

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Erin Fratto: And then you need to know if you receive direct financial assistance or in kind support, so if you are getting your eligibility from your state level health department.

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Erin Fratto: What kind of support is that is it financial is it in kind, is it condoms is a test kits.

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Erin Fratto: What does that look like, for you, and then, if you have a contract pharmacy they will also need to register and then all communication will come from no reply at her so Doug emailed so we recommend, adding that to your email systems spam filter or you just won't get any communications.

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Erin Fratto: Next slide.

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Erin Fratto: All right, authorizing official, this is the the main contact or the covered entity, for your health department this person bears the responsibility for the 340 TV programs compliance.

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Erin Fratto: Her her set it's recommended they're fully authorized and to legally bind a 340 be covered entity into a relationship with the Federal Government and has knowledge and the practices.

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Erin Fratto: And eligible programs at that site this individual is responsible for registering the site with her set and completing recertification.

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Erin Fratto: So sometimes, this is the CEO and the health officer, at the very top person who signs all the contracts, sometimes that person delegates authorizing official duties.

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Erin Fratto: To a program manager at division director of euro director.

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Erin Fratto: And, whatever your organ whoever your organization decides, should be the authorizing official everybody just needs to be on the same page and be aware of the responsibilities and the liability.

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Erin Fratto: That comes with that so if if you feel comfortable legally binding your organization to 340 be rules and regulations go for it.

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Erin Fratto: When I was in a state health department, I was a lowly program manager and I Sir doesn't authorizing official that later transitioned to the executive director.

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Erin Fratto: But it took a lot of time and education for that transition to happen, so there might be a lot of conversations that need to happen if you're a program level person and you need to educate your chain of command, but again, build into that timeframe of that quarterly registration period.

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Erin Fratto: Next slide the primary contact is more of a day to day business operations person, so this is the second contact for the covered entity, they receive her information from her so same as the authorizing official they don't have any authority to change your update, but they do have.

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Erin Fratto: But they do have communication and information, so this person is usually bothering the authorizing official like hey this important date came out hey I need to remind you of this, so the primary contact more.

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Erin Fratto: closer to the service level closer to the clinic level like I said day to day operations.

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Erin Fratto: Next slide so once you're registered once you're in the program you need to annually recertified this is done once a year, you need to recertified to ring remain in the Program.

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Erin Fratto: email notifications will come out to both the primary contact and authorizing official that this is coming up it's usually around the same time, every year in this it's for Section three teen grantees it's usually in the spring.

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Erin Fratto: And it's done through the office of pharmacy affairs information system, which is a database that all 343 things happen.

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Erin Fratto: In and a failure to recertified will result in termination from the 340 be program and, if you want to get back into the 340 TV program you have to re register, which is its own thing so once you register on the first 15 days of any calendar quarter, make sure you recertified annually.

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Erin Fratto: Next slide.

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Erin Fratto: Okay baton passed back.

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Stephanie Arnold Pang: Great going to do a few 348 compliance basics we're getting some good Q amp a.

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Stephanie Arnold Pang: Both in the chat and then good questions in the Q amp a and the chat we've tried to answer some we're going to try to take some live as well, so.

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Stephanie Arnold Pang: What are some eligibility basic so we talked about a lot about provider eligibility and registration now let's talk about patient eligibility the number one the.

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Stephanie Arnold Pang: Three part number one rule of 340 be and patient eligibility is the patient needs to meet three prongs of a patient definition.

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Stephanie Arnold Pang: To be an eligible patient number one the patient needs to have an established relationship between them themselves and the 340 be covered entity, so this is usually.

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Stephanie Arnold Pang: shown in a in a documented in a medical record, so does the does the covered entity keep in medical record or, for that patient.

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Stephanie Arnold Pang: Number two the patient needs to receive a health care service or services from a provider employed by the covered entity or providing services for the covered entity under contract.

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Stephanie Arnold Pang: Number three patient needs to receive a health care service, our services consistent with the grant through which the covered entity gained the game 340 be eligibility, so in this instance, or whatever.

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Stephanie Arnold Pang: Section section 318 grant that the covered entity is eligible under there was an faq he will be slightly different than a title 10 agency, for example.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: So the next.

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Stephanie Arnold Pang: Big compliance 340 be issue is diversion so 340 be covered entities must not resell it resell or otherwise transfer 340 be drugs to ineligible patients meaning patients who do not meet the patient definition.

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Stephanie Arnold Pang: This would be considered diversion and the entity would be out of compliance with the 340 be program and had that would have the possibility of having to repay the savings from those 340 be drugs to the manufacturer next slide.

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Stephanie Arnold Pang: Here, and I might cover i'm covering this one.

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Stephanie Arnold Pang: Knowing of handling back to you sorry.

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Erin Fratto: No you're fine.

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Erin Fratto: We go back to my.

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Erin Fratto: notes okay perfect.

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Erin Fratto: medicaid and duplicate discount so both medicaid and 340 be covered entities are legally entitled to receive a discount on the price of drugs, however, only one can actually receive that discount.

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Erin Fratto: So covered entities must accurately accurately report, how they build medicaid fee for service drugs.

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Erin Fratto: On the medicaid exclusion file I know not all local health departments are billing in this as a consideration when we're talking about if you're going to go savings or you're going to go.

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Erin Fratto: Revenue generating route, but just know if your billing and you're also a three four to be covered entity there's a few extra steps.

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Erin Fratto: The main point is that you want to avoid duplicate duplicate discounts if duplicate discounts are created you're going to have to pay them back.

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Erin Fratto: So it just creates a logistical nightmare upon enrollment into the 340 be drug pricing program and every year after.

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Erin Fratto: covered entities will need to self identify if they're going to carve in or carve out if carving out covered entities and contract pharmacies must maintain separate inventories of medications.

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Erin Fratto: And then of carving in the covered entity must inform medicaid that it is dispensing 340 be drugs.

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Erin Fratto: To medicaid beneficiaries and then they must have a system in place to prevent duplicate discounts so just a few things to think about.

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Erin Fratto: it's totally possible to bill medicaid fee for service and also be a 340 be covered entity there's just a few business processes to account for and do a little see ya on the duplicate discount so you don't have to pay anything back.

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Erin Fratto: I think I also have the next slide to.

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Erin Fratto: Perfect so the whole point of the 340 be drug pricing program is actually the medications so how a covered entity purchases 340 be medication really depends on how they're set up.

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Erin Fratto: Some covered entities have in house pharmacies or pharmacy licenses and they just spent or administer their own medications on site.

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Erin Fratto: Some use contract pharmacy or multiple contract pharmacies and the covered entity or your organization really should determine what is needed and what that need is will determine if you do one or both or either of these procurement methods.

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Erin Fratto: Next slide.

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Erin Fratto: A lot of covered entities choose to access medications using a contract pharmacy if you're not already set up with a pharmacy license or in house pharmacy services it's often.

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Erin Fratto: easier and just logistically speaking to contract with a pharmacy pharmacies usually have a lot of expertise in this area.

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Erin Fratto: But the one thing that I really want you guys to know is that ultimately compliance rest with the covered entity.

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Erin Fratto: So even if you're contracting with walgreens even if you're contracting with walmart the 340 be compliance still rests with you.

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Erin Fratto: Every covered entity should evaluate which model fits their 340 TB program best.

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Erin Fratto: And even if the contract pharmacy is already an established contract pharmacy for others, or they have other covered entity numbers, they still must register with you.

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Erin Fratto: So this is one piece that you have to get figured out before you register, because you need to have that contract pharmacy agreement signed and in place.

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Erin Fratto: And that's one thing that office of pharmacy affairs oftentimes asks to see, and they want to see that that direct relationship is happening, and they don't have a lot of contract pharmacies just registering without a covered entity agreement.

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Stephanie Arnold Pang: Before we go to the next section Aaron we do have a question in the Q amp a to explain carving in and carving out again.

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Erin Fratto: Yes, we go back to that slide for me Rebecca.

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Erin Fratto: The medicaid and duplicate isn't perfect so basically carving out means.

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Erin Fratto: That you don't you don't mix your patient patient populations at all you don't cross over you have 340 be.

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Erin Fratto: And you have medicaid patients, if you bill for medicaid there's no crossover there's no potential for duplicate discounts you basically have 340 TB patients and you have medicaid patients.

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Erin Fratto: So, or if you don't bill, or you don't interact with medicaid patients, then you would also carve out so if you're not a billing health department you don't need to worry about carving and and carving out because you're not building medicaid.

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Erin Fratto: carving in means that you are billing and you are using 340 before fee for service What that means is that the discount.

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Erin Fratto: needs to be accounted for and usually there's very complex systems happening at the pharmacy level to divide where that discount is going with your medicaid patients.

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Erin Fratto: So if you are a health department that is billing and you do have a medicaid population and you want to utilize 340 be.

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Erin Fratto: I would recommend a contract pharmacy and a third party payer administrator because that's going to again make sure you're not having duplicate discounts that you're going to have to pay.

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Erin Fratto: So when I was at a health department, we didn't build so it was easy we just carved out.

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Erin Fratto: there's a little button when you register, you have to click it if you carve in or you have to click if you have to carve out, you have to choose if you're carving inner carving out.

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Erin Fratto: that's another thing to really think about before registering.

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Erin Fratto: Is am I going to carbon, am I going to carve out does my health department bill does my health department not bill.

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Erin Fratto: What does our patient population look like what percentage is covered by medicaid fee for service and how is this going to complicate our operations.

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Erin Fratto: So just a few considerations and if you guys want to talk more about proving and and carving out and we're happy to provide some tea on that stephanie and I have another consultant that we work closely with.

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Erin Fratto: Around carving and carving out and medicaid fee for service, because it does get quite complicated yeah.

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Stephanie Arnold Pang: And you have to make the distinction and the determination, for your entire medicaid population, so another question in the Q amp a was started asking about.

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Stephanie Arnold Pang: Specific services so really, this is about your entire medicaid population that use that use serve at your your clinic so it's it's not it's determined by the medicaid population.

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Stephanie Arnold Pang: carving and or carving out not is not you can't pick and choose among the services or this person and that person has to be determination free your entire medicaid population that you see if you bill yep.

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Erin Fratto: And once you pick a carbon carve out, you have to stick with that until you recertified if you decide it's a mess and you don't want to do it and you want to switch to carving out if you carved in you can re certify and change your carbon carve out.

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Stephanie Arnold Pang: I see another question, can you pick and choose to carve in and for only certain medications i'm mcnair i'm gonna let you do that.

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Erin Fratto: Well, you, you can, but you would have to make sure at your program level that you have decided that, because you couldn't if you are carving out.

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Erin Fratto: For the majority, but then you plugged in you would still have to have a medicaid exclusion file with your state medicaid office and you again would have to make sure the billing is in line with what you're deciding so it's more tied to the service your billing for.

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Erin Fratto: Jeff anything dad stephanie.

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Stephanie Arnold Pang: And I medicaid.

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Erin Fratto: Yes, again like stephanie said, the questions it's kind of snowball once you start thinking about operationalize it, but like I said we're happy to talk through different scenarios and provide one on one ta or links to resources.

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Stephanie Arnold Pang: And dwayne ash just put a very good comment in the chat that helps clarify this so look into that, thank you for that.

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Erin Fratto: Thank you dwayne.

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Erin Fratto: Right exactly we want to make sure that medicaid not thinking they're getting a rebate and the program is not thinking they're getting a rebate because that's going to lead to the duplicate discounts.

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Erin Fratto: And you're right the third party provider will have to pay that the drug manufacturer and I don't want to be writing any checks to like Pfizer.

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Erin Fratto: They don't want money.

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Erin Fratto: going to write a check to them.

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Erin Fratto: Okay cool you can go back to the next section, and I think it's definitely yeah.

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Stephanie Arnold Pang: So i'm going to do some addressing infectious disease kind of faqs we often get the next slide so first.

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Stephanie Arnold Pang: we're going to take a big phrase which it will be confusing but we'll we'll break it down so first question come with this is referred to as grantee combined purchasing and distribution.

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Stephanie Arnold Pang: So generally taking 340 medications purchase centrally like at a State health department and providing them to other clinics and entities generally, this is what combined purchasing and distribution is.

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Stephanie Arnold Pang: So most state health departments do this it is like I said is really common in public health and public health, but it's not really within the 340 be model with 340 be tends to be thinking about clinic level service sites.

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Stephanie Arnold Pang: Your clinic purchases medication and provide them to and provides them to patients it doesn't we're trying to kind of do a round peg square hole other way.

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Stephanie Arnold Pang: About for fitting public health into into 340 be so, so the sharing of 342 entities inventory through this combined purchasing and distribution is.

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Stephanie Arnold Pang: Only allowed when first approved by herself otherwise it's considered diversion so state health departments can purchase drugs centrally and provide them to local health departments, I think I think most do.

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Stephanie Arnold Pang: But the state health department is as the covered entity in this instance, is responsible for getting a combined purchasing and distribution program approved by herself.

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Stephanie Arnold Pang: So this otherwise it's considered diversity, so this is the responsibility of the grantee who who purchases all the medications centrally, but if you are a local health department participating maybe unbeknownst to you in a grantee combined purchasing and distribution Program.

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Stephanie Arnold Pang: You could anticipate in the future that you'll have to go through a little bit of additional processes to be part of this program.

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Stephanie Arnold Pang: get it do single sign off do some additional forms, basically, that is, the grantee getting additional.

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Stephanie Arnold Pang: buy in from you as a coach as a sub grantee to to participate in the grantee combined purchasing a distribution, so we wanted local health departments to be aware.

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Stephanie Arnold Pang: That this is something that's out there in the ether, because as more and more States apply for grantee combined purchasing and distribution, they have to go to their local health departments to get a buy in.

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Stephanie Arnold Pang: Especially for this program and I should note that there are a few states that once they realize that they need to get approval from her so for this for this type of program have chosen to no longer purchase centrally.

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Stephanie Arnold Pang: But encouraged, but then, but just give their give access through your financial relationship or income contributions to directly to their locals and then encourage their locals.

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Stephanie Arnold Pang: health departments to purchase directly so just a few things to be to be aware of with 340 be and and relationships with state health departments.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: So EP 10 340 be tends to be a question we get so the question is, can I provide can I use three four to be medications for a PT both the index patient and the partner or partners.

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Stephanie Arnold Pang: So if the patient, and if the index patient in this instance meets the 340 be patient definition and a visit test positive for an STD or.

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Stephanie Arnold Pang: You may use 340 be drugs for expedited partner therapy for the partner as well.

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Stephanie Arnold Pang: The rationale is that a PT is actually treatment for your patient so it's that the the treatment of the partner is treatment for the index patient because you're preventing reinfection the same rationale as to why you utilize PPT.

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Stephanie Arnold Pang: at all and I purposely brought my EP it works and CSD mug for today's conversation.

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Stephanie Arnold Pang: So the combination of the 340 patient definition, as well as there's explicit language in the STD peach grant that allows.

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Stephanie Arnold Pang: That outlines that the the receiving of a PT is a covered service within the SVP grant so.

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Stephanie Arnold Pang: It is a covered covered service, so the use of 340 be drugs or eight PT should be included in your 340 policies and procedures and to make it clear that you're supporting a PT with 340 because you're preventing reinfection for your index patient.

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Stephanie Arnold Pang: Next slide.

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Stephanie Arnold Pang: and turning over to Aaron for this one.

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Erin Fratto: Thank you so grants and cooperative agreements authorized by section 318 they all kind of fun different programs so it's recommended that you get familiar with the scope of your grant that authorizing your use of 340 beat but regardless of what brand that is.

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Erin Fratto: You can leverage the 340 be drug pricing programs for program collaboration and service integration efforts.

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Erin Fratto: access to medication is tied to that patient definition that stephanie was talking about the key here is to make sure that patient definition is met and that patient definition is met at every visit.

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Erin Fratto: We can end the epidemics with program collaboration and service integration, providing comprehensive care treating folks holistically and really utilizing the tools available to us to maximize.

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Erin Fratto: Our financial resources so whether that is for prep or viral hepatitis treatment.

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Erin Fratto: Like stephanie said some know flows are specifically intended to end the HIV epidemic, but just because.

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Erin Fratto: you're not funded by that specific Novo doesn't mean you still can't engage in activities that are going to lead to ending the HIV epidemic in your jurisdiction.

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Erin Fratto: So it's all tied to that patient definition once you meet that patient definition.

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Erin Fratto: It really opens up to what activities, you want to engage in and what are beneficial to your patient populations, and we do have a lot of really great 340 be an ending the epidemic resources will drop that link in the chat for you, but a lot of operational ization tools, a lot of.

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Erin Fratto: Contract templates mo use recommendations Frequently Asked Questions all centered around ending the epidemics utilizing a section three team designation.

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Erin Fratto: Next slide Rebecca.

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Erin Fratto: And one of the things I was really excited to talk to you guys about today was the public health syphilis response.

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Erin Fratto: We really want to highlight how the 340 be drug pricing program can make syphilis treatment more accessible and more equitable.

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Erin Fratto: Most private providers and pharmacies don't stop by selling we just learned in a previous slide it's expensive if it's not in stock, it can take five to seven days to get I still in.

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Erin Fratto: Is not often at her at the fingertips of providers and so often providers refer patients to you guys the local health department.

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Erin Fratto: That adds time that adds travel that adds additional cost to the patient, including transportation childcare missing work hours and then oftentimes there's also a clinic fee to that patient.

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Erin Fratto: This creates a lot of feelings for the patient, a lot of trauma and sometimes that patient disappears and is lost a follow up.

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Erin Fratto: treating patients where they're at in the providers office where they're at reduces the need for referrals.

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Erin Fratto: It reduces losing folks to follow up and it also improves continuity of care reduces frustration and it's just really a trauma informed practice.

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Erin Fratto: So you know sense syphilis as an urgent public health threat and public health is ultimately responsible for the control of syphilis.

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Erin Fratto: In this practice a state or local health department stocks, the bike stolen and delivers it to wherever the patient has been seen this process is written into policies and procedures auditable records are maintained.

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Erin Fratto: oftentimes the public health report or the morbidity report is that auditable record.

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Erin Fratto: we've been talking to a lot of jurisdictions about this and if you'd like more information on how to respond to the syphilis epidemic in your jurisdiction we'd be happy to talk more about that.

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Erin Fratto: But I really wanted to highlight 340 be as a tool to get surplus of back under control and save the babies, so please be open to this concept.

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Erin Fratto: it's permissible by the STD pH grant it's explicit in grant language.

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Erin Fratto: If you are a covered entity authorized by a different nofollow or knows that funding opportunity that's not the STD grant.

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Erin Fratto: will want to talk and see how we can leverage that or maybe switch a partnership to the STD program and I see in the chat that people are doing this yay do it treat selfless.

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Erin Fratto: Okay that's, I think, with my soapbox i'll pass it to stephanie and i'm glad that we're getting so many questions because we did leave a lot of time for questions i'm glad you guys are showing up as anticipated.

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Stephanie Arnold Pang: So in some.

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Stephanie Arnold Pang: For 340 be key concepts are number one only certain providers are eligible, and I put some phrasing underneath and.

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Stephanie Arnold Pang: we've put some crazy underneath in parentheses in parentheses and tell us, because this is the 340 be language when I first came to 340 be it's like it's a whole nother language, it takes a long time to like get your brain.

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Stephanie Arnold Pang: functioning and using a 340 language as opposed to like I don't know normal English or even clinical language so number one is only certain providers are eligible, which is referred to as eligible providers or covered entities.

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Stephanie Arnold Pang: Number two only certain patients are eligible eligible patients or patient definition or diversion if you're diverting drugs to ineligible patients and or three is tracking and keeping records are key is referred to as auditable record so records that can be provided in an audit.

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Stephanie Arnold Pang: And so, put it through this thread a little bit more Hawaii.

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Stephanie Arnold Pang: Consumption conceptualize this when I do ta with with the with our grantees is you need to track that drug from the point of work of where it's.

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Stephanie Arnold Pang: purchased to where it gets dispense to an individual patient So how can you put can the if you're in an audit, can you pull the thread of tracking that drug all the way down to dissension dispensing.

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Stephanie Arnold Pang: Or you know getting the shot in the butt, for example, for bicep So how can you pull that pull that thread all along that drugs.

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Stephanie Arnold Pang: Like basically and that's keeping an auditable record and number four you need to keep need to choose between 343 drugs and medicaid drugs is our carbon versus carve out conversation or duplicate discount.

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Stephanie Arnold Pang: and

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Stephanie Arnold Pang: Next slide So these are lots of resources we provided for you from her Sir the office of pharmacy affairs has their own 340 oh pace we refer to it as their acronym database there's a separate.

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Stephanie Arnold Pang: entity called Texas, the 340 the prime vendor program, that is, that is three horses through paid 340 be ta provider, so a lot of they're really great on medicaid.

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Stephanie Arnold Pang: And they're growing in their expertise on grants, so I would selfishly recommend ncs D or NATO as you're if you're if you're grantees specific questions, but if you have.

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Stephanie Arnold Pang: The great on medicaid and pm, in that way, so if you've really detailed medicaid questions I do recommend you go to a Texas.

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Stephanie Arnold Pang: And cst has a 340 to be faqs and a recorded webinar I did almost three years, maybe even over three years ago now, at this time, takes a lot of the same information, but is.

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Stephanie Arnold Pang: goes up somewhat a little bit more in detail in some STD specific questions, so if you're interested in that it's there.

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Stephanie Arnold Pang: And CC NASA had provided a little memo when the section 318 redefinition occurred, three years ago, then there's the ABC of 340 be.

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Stephanie Arnold Pang: webinar recording and our 340 be ending HIV epidemic materials and then 340 be health is the membership organization and for the.

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Stephanie Arnold Pang: Hospitals who are part of the 340 TB program and then also some contract pharmacy faq so lots of good additional resources on that slide as well, and I think with that we're ready to go to questions.

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Rebekah Horowitz (she/her): Yes, we are so i'm going to ask one that was in the chat first just so that I can move away from the chat.

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Rebekah Horowitz (she/her): And if a local health department issues a mo a and an agency within an office provides an agency within kind supplies what no flow or grant number should we communicate to the Agency when they're registering.

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Rebekah Horowitz (she/her): Their mo you are mo for 340 be so if the Community health department is funded under PS.

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Rebekah Horowitz (she/her): What grant number would they share with the Agency that's receiving the mo a.

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Stephanie Arnold Pang: So.

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Stephanie Arnold Pang: i'm going to read a little bit into this example, if I read into this question and i'd like to ask the question or to clarify this, but i'm reading into this, that they are not the grant T.

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Stephanie Arnold Pang: That they are a sub grantee from the state I don't know isn't it 1999 when I don't know what grant that is up to top my head Aaron.

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Erin Fratto: that's your grant girl.

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Stephanie Arnold Pang: Oh, is it oh.

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Stephanie Arnold Pang: let's see I don't I don't do numbers very well so i'm reading into this that.

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Stephanie Arnold Pang: that you are a local apartment a sub grantee of the scd peach grand from i'm going to say misery in this instance because it's first one, I think I thought.

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Stephanie Arnold Pang: So if you're a sub grantee under STD pH you cannot.

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Stephanie Arnold Pang: have in our slide you can't provide eligibility on to another level, the eligibility stops with you as the sub grantee if you have a partnering entity that you think would greatly.

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Stephanie Arnold Pang: benefit from 340 be eligibility, then you should encourage that that that clinic have a related to have a conversation with the state health department to get their own direct 340 the access so.

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Stephanie Arnold Pang: In this instance i'm assuming that you're The sub grantee so you wouldn't be providing any additional information to the sub grantee to your to your sub grantee because then it's a sub sub which isn't eligible.

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Stephanie Arnold Pang: So that's I think that answered that question, but if you are, but if you are a local health department that is a grantee under 19 1901 or an EA T grant or the HIV grants.

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Stephanie Arnold Pang: So you are the grantee is the local health department and then you have sub grantees you should be writing your no phone number so 19 in this instance it's 20 1901.

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Stephanie Arnold Pang: As well as your grant number, so you get your grant number that is your individual grant number for the state of or for Chicago health department.

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Stephanie Arnold Pang: That you get through 19 and 20 no one that's the number that you provide to your sub grantees for their eligibility.

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Erin Fratto: And just another point that i'd like to clarify since we're talking about in kind supplies.

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Erin Fratto: Whatever no photo or whatever grant funds, those in kinds of pies were purchased with should be the no photo or the grant number given.

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Erin Fratto: To the sub grantee or the covered entities, so if i'm out of state health department and I buy condoms with my HIV prevention money, and that is the income contribution.

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Erin Fratto: I would then give that sub grantee or that covered entity that HIV grant number, because the in kind contribution was purchased with those grant funds.

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Erin Fratto: So whatever in kind services are being provided you need to go back to the financial route, because that is what is providing that eligibility.

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Erin Fratto: So if you are at a State health department and you have three different three teen grants you really need to keep that delineation.

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Erin Fratto: of your income services straight, so you know do where your STD covered entities, who are your viral hepatitis covered entities.

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Erin Fratto: And who are HIV prevention covered entities and some health departments choose just you know one grant because it's more all encompassing, but I wanted to clarify that because we we didn't really hammer that home when we talked about in kind support.

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Rebekah Horowitz (she/her): Thank you Okay, I was trying to group these in a way that was going to make it easier to answer them, but it hasn't happened in my mind so i'm just going to go chronologically So the first question is what are some of the disadvantages for becoming 340 be eligible.

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Stephanie Arnold Pang: I love this question because I think it's great so obviously we talked about the financial benefits to Rebecca talked about that in the beginning, as well as all throughout this lot of cost savings and possibly if you're building even some some additional revenue.

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Stephanie Arnold Pang: to your to your clinic.

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Stephanie Arnold Pang: i'd say that the the drawbacks are the monitoring that you have you have to keep a policies and procedures outlining what you're doing and why you're doing it.

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Stephanie Arnold Pang: You have to keep auditable records, you have to make this determination for medicaid there's just a lot of monitoring and many public health department state local.

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Stephanie Arnold Pang: any of them might not have the capability, or the you know the the bandwidth to do that, so that is a determination, you have to make at your at your level if the benefits outweigh the risks and the you know, and then the additional requirements that come with participating in this program.

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Stephanie Arnold Pang: and

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Stephanie Arnold Pang: And the other thing i'd say is that there's many things are in statute for 340 be are in regulation and many are not as many as in practices or what has been done an audit or.

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Stephanie Arnold Pang: not been found an audit and some of this is great, and do you have to determine again it's a determination about benefits versus risks to meet meet the goals of your public of your health department.

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Stephanie Arnold Pang: enter in a.

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Rebekah Horowitz (she/her): Second, that.

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Erin Fratto: I was going to summarize it with.

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Erin Fratto: administrative burden.

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Yes.

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Rebekah Horowitz (she/her): So the next question is, could you speak to have syringe service programs who partner with STD clinics, to provide services may or may not take advantage of the 340 be program and generate revenue.

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Erin Fratto: And yeah I think that's a great question so a certain service program to generate revenue would be need to be set up to bill.

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Erin Fratto: They would probably need to have a medical officer medical Director or a medical person that's.

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Erin Fratto: available to prescribe medications as well as to bill under.

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Erin Fratto: So I think it's a great idea I don't know of a lot of certain service programs that are structurally organizationally set up yet to take full advantage of the 340 be programmed to generate revenue.

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Erin Fratto: it's a it's a great in concept and it's totally doable and workable and they would need to have a relationship.

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Erin Fratto: With the grantee the state level health department and that could either be in kind contributions or direct financial services lots of students service programs.

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Erin Fratto: already participating condom distribution programs, a lot of them already received chlamydia gonorrhea test kits or testing allocations at their state lab.

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Erin Fratto: So I think the infrastructure is there the syringe service program We just need to figure out a few program level things.

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Erin Fratto: on how to make that work if a certain service provider is operating under the direction of a medical director and have standing orders for treatment.

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Erin Fratto: And they have a pharmacy license or they have a contract pharmacy they could very easily treat their participants for chlamydia gonorrhea and even syphilis if they have the medical staff to do that or their relationship with a contract pharmacy to do that.

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Thank you.

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Rebekah Horowitz (she/her): The next question is, are there disadvantages to pharmacies become in 340 be eligible either of you have the ability to speak to that.

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Erin Fratto: We bought a new, at the same time.

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Stephanie Arnold Pang: i'd state so while come contract pharmacies have our.

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Stephanie Arnold Pang: We talked about them separately it's best to think about them as a as part of the covered entity and part of the clinic so far.

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Stephanie Arnold Pang: There are a lot of positives for contract pharmacies, but contract pharmacies are an extension of you as the cover antiques extension of your clinic So if you are partnering with a contract pharmacy you have to maintain and review their their.

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Stephanie Arnold Pang: Their policies procedures, there are actually 340 be activities because anything they do wrong is going to come back on you it's you are you as the authorizing official for the for the calm for the covered entity own own them essentially and own their activity so.

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Stephanie Arnold Pang: I put I put my answer to that question as as the Pope the PS to my answer to the previous question of you know what are the advantages and disadvantages of participating so there's not separate.

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Stephanie Arnold Pang: advantages or disadvantages for pharmacies because they're part of they are part of a covered entity.

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Erin Fratto: And my answer was going to be the disadvantages, this is the sales emails and phone calls you're going to get from the contract pharmacies.

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Erin Fratto: Once they figured out you're covered entity.

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Erin Fratto: and honestly pharmacies are businesses they're going to make money so they make money from 340 by taking a cut of the revenue or savings that's done with fees that they're going to charge you dispensing fees.

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Erin Fratto: or they're going to ask for some sort of compensation so every covered entity is in charge of working that out with the contract pharmacy but just be aware that that that is the thing they're not just going to be doing it out of the kindness and goodness of their heart.

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Erin Fratto: Contract pharmacies don't make a ton of money from section three medications they're going to make a lot of money by being an eight at provider Ryan white provider.

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Erin Fratto: A hospital provider where hospitals have high volumes of medication.

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Erin Fratto: you're going to see lots of contract pharmacies want your business they like you said they make money it's a business model so just being aware of those when you enter into conversations.

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Erin Fratto: The benefit of having a contract pharmacies they already speak this language they probably have a 340 be covered entity agreement template.

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Erin Fratto: they're going to be able to make sure that you don't have duplicate discounts they're going to be able to speak and administrative language that might sound very foreign to you if you're starting off on this.

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Erin Fratto: So to stephanie's point there's not really a disadvantage because they're an extension of yourself, but you do just need to be aware, you know of the of the contract pharmacy angle and their perspective.

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Erin Fratto: And the sales phone calls.

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Rebekah Horowitz (she/her): Thank you.

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Rebekah Horowitz (she/her): Does it make a difference that our.

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Rebekah Horowitz (she/her): grant for HIV prevention is under the statutory authority of Section 301 and 37 teen would that still qualify, because under three under three and 17 for 340 be in the earlier slide it said 18 1802 was under 318 but our know Fo says three at one and 317.

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Erin Fratto: So I thought was section three teen as well, are you ready.

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Stephanie Arnold Pang: I didn't know I didn't.

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Stephanie Arnold Pang: I I would have to look that up i'd have to look up the original novel I thought it was 318 and as well, but three seven teen is eligible it's the tuberculosis eligibility so.

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Stephanie Arnold Pang: it's interesting to me but it's not impossible three so this The short answer is 317 is still eligible.

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Stephanie Arnold Pang: So the short answer is yes it's still a grant still eligible it's just under a different eligibility and just know that every grant curious with it a different patient definitions you'd have to think through what are eligible services from that specific grant.

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Stephanie Arnold Pang: That make that would bring your patient eligibility and while i'm speaking to the patient eligibility and grant specific specificity, I often get the question of what's for scd pH, which is what the mcs DS like main bread and butter is, is where the membership organization for the STD.

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Stephanie Arnold Pang: pH grantees 19 1901 apparently.

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Stephanie Arnold Pang: The is what I would what I get for ta that the STD patient definition is that a patient should receive.

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Stephanie Arnold Pang: counseling among other STD risks and conversation about the sexual health history at every.

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Stephanie Arnold Pang: visit and then that individual receives testing, as a result of that counseling so that you did not have to do testing for testing sake.

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Stephanie Arnold Pang: If the individual does not have any risk factors which you determine, through a sexual health history, they would.

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Stephanie Arnold Pang: But if they through your sexual health history require testing.

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Stephanie Arnold Pang: Then you should do the testing so conversation about sexual health history and risk factors testing for the CDC guidelines as as a result that that's what I give as the STD patient definition, not in statute it's just my recommendation for good STD prevention and care.

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Erin Fratto: And the only thing that I would add back to the statutory authority, if you do have a grant that's granting 318 eligibility you're going to register under TV.

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Erin Fratto: Not stv so it's a different covered entity type and like stephanie said it's a different patient definition not saying that you can't do.

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Erin Fratto: STD treatment and prep and viral hepatitis, but you would need to make sure that TV patient definition is met, which is probably going to be linked to TV testing, treatment and care at every visit which probably doesn't happen as often as the STD activities.

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Rebekah Horowitz (she/her): Good point.

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Rebekah Horowitz (she/her): next question is, can you speak a bit more about 340 be pricing covering prep medications.

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Erin Fratto: covers them.

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Erin Fratto: 340 be covers any medication that's clinically indicated, so if you have somebody come in and they're worried about STDs HIV is an STD So if you want to prevent HIV let's get them on prep.

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Erin Fratto: prep now has a generic so there's less revenue to be generated there's also been a few policy changes that prevented additional revenue to be utilized if a patient is using a patient access program so I wouldn't.

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Erin Fratto: I wouldn't rely on prep to fund your program you're not going to generate a lot of revenue, but you absolutely can provide prep if you're seeing a patient, and they would benefit from prep let's let's get prep out their prep on 340 be is like $30 let's do it.

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Rebekah Horowitz (she/her): yeah.

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Rebekah Horowitz (she/her): i'm.

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Rebekah Horowitz (she/her): If a State already purchases 340 leave medications for local health departments under the TV eligibility could they expand that to include STD eligibility.

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Stephanie Arnold Pang: shorter answer is yes, assuming i'm assuming they're the states have three fifths STD grantee in this in this instance.

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Stephanie Arnold Pang: Yes, noting that they would have to do a combined purchasing and distribution delivery approval process, they should be doing this for get approval process for the TV 317 as well.

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Stephanie Arnold Pang: And so, yes, they can expand to STD medications if they if they choose to but would have to go through the combined purchasing is distribution plan approval process.

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Stephanie Arnold Pang: Great.

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Rebekah Horowitz (she/her): The next two are asking for a bit more detail on things that were covered um I think people are excited about both of these opportunities, so the first is, can you review the big delivery system to other providers again.

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Erin Fratto: yeah I saw a lot of great exciting chat happening, and I think we should clarify on that, yes, so.

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Erin Fratto: first thing to clarify, is that this is known as isilon delivery that's kind of a term that's out there, I didn't use that on my slide I use public health response to syphilis.

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Erin Fratto: Because bicycle and delivery I think strikes fear into some folks hearts, and it really is public health response to syphilis So yes, the intent is to take health department by someone.

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Erin Fratto: Deliberate to that patient that patient is probably going to be an ad an Ob gyn office they might be their primary care office they might be in the emergency room.

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Erin Fratto: The point of the isilon delivery or the public health response to syphilis is to make sure that patient gets treated.

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Erin Fratto: So the treating treating provider is acting as a partner to public health to administer that treatment that is provided by public health.

432
01:09:25.290 --> 01:09:35.220
Erin Fratto: That patient record is linked to a reportable condition, which is the simplest the health department maintains that record, because the health department is responsible for.

433
01:09:36.180 --> 01:09:37.440
Erin Fratto: The control of syphilis.

434
01:09:37.860 --> 01:09:45.270
Erin Fratto: So, like like I said in my slide all of this is really outlined and policies and procedures there's often paperwork to be signed, sometimes a packing slip.

435
01:09:45.360 --> 01:09:52.290
Erin Fratto: goes with that by selling from the health department for the provider to initial that they're administering this medication on public health behalf.

436
01:09:52.740 --> 01:10:02.220
Erin Fratto: And so there's a little bit of operationalize miss that happens, and I see some peers in the chat sharing their information, and I think that's awesome we need health departments to do this to.

437
01:10:02.520 --> 01:10:12.000
Erin Fratto: Let everyone know that it's doable and it's a thing, and the public health impact is is huge, if you can prevent a dozen congenital syphilis cases.

438
01:10:12.720 --> 01:10:23.700
Erin Fratto: And there's just no quantifying that and like I said it's a it's a low income already struggling patient who's pregnant with syphilis walks out of that doctor's office.

439
01:10:25.410 --> 01:10:36.720
Erin Fratto: How are you going to guarantee they're going to show up at the local health department and pay the $40 clinic fee to get a really painful peanut butter cold injection in their glutes like that's just.

440
01:10:37.650 --> 01:10:40.530
Erin Fratto: that's just not going to happen, we see it all the time tons of loss to follow up.

441
01:10:40.800 --> 01:10:48.000
Erin Fratto: So the idea is that that patients at that primary care provider that provider they're already comfortable with they are not navigating the stigma of an STD clinic.

442
01:10:48.180 --> 01:10:54.750
Erin Fratto: they've already received some sort of routine care that's already diagnosed that syphilis that doctor's office calls the health department and they're like yo.

443
01:10:55.140 --> 01:11:02.730
Erin Fratto: I got syphilis here I don't have anybody still in, can I just dispense some seth track zone and you'd like, no, no, no.

444
01:11:03.270 --> 01:11:06.780
Erin Fratto: Rebecca will be right out with her cooler full of isilon.

445
01:11:07.290 --> 01:11:19.680
Erin Fratto: And then Rebecca runs that by cell into that doctor's office that patient is treated you're done you just save the baby so that's really the concept and I like I said I see a lot of chat happening, and I would love for folks to share.

446
01:11:20.400 --> 01:11:23.730
Erin Fratto: What it looks like in their jurisdiction or their health department and it can be.

447
01:11:24.150 --> 01:11:32.070
Erin Fratto: slightly different from jurisdiction to jurisdiction, because it really depends on your health officer you're standing orders your medical direction, how you keep records.

448
01:11:32.640 --> 01:11:46.800
Erin Fratto: What surveillance system you interact with if you have mobile D is or not just lots of different factors, but did that answer that provide a little bit of clarifying information, and I know you're all know picturing Rebecca running out with isilon to.

449
01:11:47.100 --> 01:11:47.760
Rebekah Horowitz (she/her): Do it.

450
01:11:47.970 --> 01:11:49.380
Rebekah Horowitz (she/her): i'll do it for all of you.

451
01:11:51.990 --> 01:12:02.790
Rebekah Horowitz (she/her): So the next question has to do with EP at 340 be Terry says she's delivering some tomorrow so amazing and terry's emails in the chat.

452
01:12:03.780 --> 01:12:13.740
Rebekah Horowitz (she/her): terry's in San Bernardino and has been indicated that they're doing a lot of this delivery so folks want to reach out to Terry for more information, their emails in the chat.

453
01:12:15.240 --> 01:12:24.930
Rebekah Horowitz (she/her): So very exciting um next question is, can you provide more information for EP T for 340 be eligible patients.

454
01:12:25.260 --> 01:12:36.720
Rebekah Horowitz (she/her): We have an in house pharmacy that does not provide us with 340 be pricing for partner therapy, because there is a lack of clarity on how to provide 340 be pricing for partner therapy.

455
01:12:39.690 --> 01:12:54.300
Rebekah Horowitz (she/her): So I think I can say one thing first, which is this elbow you're probably going to have to have a sit down with your pharmacy staff to explain to them why it could why he PT does qualify for 340 be as long as it's an eligible patient.

456
01:12:55.740 --> 01:13:06.060
Rebekah Horowitz (she/her): And they're going to be frustrated by the fact that there is not written guidance on this fact, this information is like sort of developed through the process.

457
01:13:06.930 --> 01:13:18.900
Rebekah Horowitz (she/her): of people being audited and the auditors saying yes, you use dpt in the US 340 before this EP T and we agree that it is the right decision to make.

458
01:13:20.130 --> 01:13:24.900
Rebekah Horowitz (she/her): So i'll just say that first Aaron and stephanie do you have anything to add to that.

459
01:13:26.220 --> 01:13:32.040
Stephanie Arnold Pang: um, the only thing i'd add is that then once you've convinced your pharmacy pharmacists you put it in your policies and procedures.

460
01:13:32.850 --> 01:13:43.320
Stephanie Arnold Pang: And then just, you know as Rebecca said, if this has been done through kind of like practice through our STD programs have been audited 340 TB patients have been.

461
01:13:44.100 --> 01:14:00.780
Stephanie Arnold Pang: cpt patients charts have been pulled and those entities have passed their audits, so this is so, we were giving this ta before this audit happened, and we feel even more comfortable as a result of that that audit to say that this is, you know.

462
01:14:01.620 --> 01:14:12.750
Stephanie Arnold Pang: despite not having crystal clear clarity from from herself, that this is a covered covered service, and if it is in your policies and procedures.

463
01:14:13.890 --> 01:14:23.070
Stephanie Arnold Pang: We feel comfortable giving the giving the ta that this is a covered service and she should be utilizing 340 before index patients, as well as their partner partners.

464
01:14:24.000 --> 01:14:25.920
Erin Fratto: Apparently, has also issued.

465
01:14:26.340 --> 01:14:40.050
Erin Fratto: A q&a on this, so you won't find it in any official policy, but there is a Q amp a about a PT that you can print off and take to your pharmacy and and show them in writing that a Texas an IPA say this is a thing.

466
01:14:42.210 --> 01:14:50.700
Rebekah Horowitz (she/her): Great we have two questions relating to jails and 342, the first question why aren't jails eligible.

467
01:14:50.970 --> 01:14:57.030
Rebekah Horowitz (she/her): I know that most of the organizations that manage health care and the jails are for profit organizations.

468
01:14:57.300 --> 01:15:10.560
Rebekah Horowitz (she/her): But due to the high classify selling and some other medications they are not testing and treating for St is unless a patient is symptomatic on intake local public health officials local public health.

469
01:15:11.880 --> 01:15:15.990
Rebekah Horowitz (she/her): i'm not sure what the local public of the mission of the a is in this question.

470
01:15:16.860 --> 01:15:25.170
Rebekah Horowitz (she/her): are trying to help problem solved how to get jails low class medications so STI testing and treatment becomes a standard of care.

471
01:15:26.010 --> 01:15:32.340
Rebekah Horowitz (she/her): So i'm going to quickly read the second question about jails and then throw this over to you both.

472
01:15:33.150 --> 01:15:51.360
Rebekah Horowitz (she/her): To to respond, the second question is I do Tele health through the health department for clients in jail is it okay quote unquote to deliver the clients medications off site, if I have a provider client relationship, are there any limitations provided by 340 be to this.

473
01:15:55.470 --> 01:16:03.240
Stephanie Arnold Pang: glad we have 314 minutes might take up 14 minutes just have these two questions, these are great questions, so I typed in part answer to this and then.

474
01:16:03.690 --> 01:16:05.400
Stephanie Arnold Pang: aaron's really the correctional facility.

475
01:16:05.970 --> 01:16:19.230
Stephanie Arnold Pang: Experts i'm going to turn it over to her district so jail is mostly and correctional facilities in general and typically aren't direct grantees have 340 be eligible grants, so they are not eligible on their own.

476
01:16:19.890 --> 01:16:28.740
Stephanie Arnold Pang: To be 340 to be covered entities, but as the questioner stated, we know that they're important partners for particularly STD prevention.

477
01:16:29.310 --> 01:16:41.730
Stephanie Arnold Pang: and HIV prevention and care as well, so it is an important consideration for grantees and local health departments to consider how they can partner with correctional facilities to access the population which is.

478
01:16:42.270 --> 01:16:52.620
Stephanie Arnold Pang: A key population for for STD prevention, so they wouldn't necessarily be entity covered entities couldn't be covered entities because they're not grantees on their own, but that doesn't mean they couldn't have partnerships.

479
01:16:52.950 --> 01:16:59.520
Stephanie Arnold Pang: With grantees to allow correctional facilities eligibility, and this is where i'm going to kick it over to Aaron.

480
01:17:00.180 --> 01:17:11.130
Erin Fratto: yeah no that's great stephanie and I think that eligibility is often granted within kind of contributions or direct funding so sometimes an STD viral hepatitis or HIV program will give a.

481
01:17:11.970 --> 01:17:17.490
Erin Fratto: correction facility either money or condoms or they'll support their testing.

482
01:17:17.820 --> 01:17:21.660
Erin Fratto: And that will grant the eligibility so like stephanie said the eligibility has to be met.

483
01:17:21.900 --> 01:17:33.570
Erin Fratto: So to answer that question, you could maybe incentivize hey i'll give you $1,000 at our public state or state public health lab for you to process media gonorrhea specimens boom right there that's an income contribution.

484
01:17:33.960 --> 01:17:40.770
Erin Fratto: formalize that with an mo and eligibility is granted to that jail, not their medical contractor to that facility.

485
01:17:41.490 --> 01:17:57.810
Erin Fratto: Now that facility has to make sure they're serving eligible patients, so that means that every patient or incarcerated individual individual experiencing incarceration should meet the patient definition meaning they get an SUV risk assessment, they get a screening they get.

486
01:17:59.010 --> 01:18:07.500
Erin Fratto: A service that's in line with the scope of that grant now they're eligible, so the or the entity, the jail, the correctional facility is eligible and they serve eligible patients.

487
01:18:07.830 --> 01:18:12.540
Erin Fratto: And yes, sky's the limit, then they can get discounted antibiotics to treat those.

488
01:18:13.170 --> 01:18:27.930
Erin Fratto: STDs that they're going to find with their now new screening program and they can also use three four db for other medically necessary conditions found in that visit, where the STD screening or the health activity within the scope of the grant happened.

489
01:18:31.140 --> 01:18:35.880
Erin Fratto: And then the second part of the question, the Tele health if the Tele health provider is.

490
01:18:36.240 --> 01:18:46.110
Erin Fratto: A 340 be covered entity provider it doesn't really matter where their patient physically is that that patient is a qualifying patient because they're a patient of a.

491
01:18:46.830 --> 01:19:00.060
Erin Fratto: covered entity and as long as that patient definition is met in that Tele health visit hey are you having sex hey what kind of sex so you're having what does what does your situation look like that patient definition isn't that that medication as 340 be eligible.

492
01:19:05.550 --> 01:19:16.140
Rebekah Horowitz (she/her): Thank you, we had a hand raised from grace so grace I have made it so that you are able to talk, if you would like to unmute yourself and add your comment or question.

493
01:19:26.010 --> 01:19:41.790
Rebekah Horowitz (she/her): not yet, in the meantime, we have one more question are there limitations on what you can use 340 be funds for in regards to what counts as going back into the program to improve continue expand the Program.

494
01:19:42.540 --> 01:19:55.350
Rebekah Horowitz (she/her): For example, could those funds be used to then purchase syringes for an ssp program or do to fund still count as federal funds and therefore would they not be eligible for that type of purchasing.

495
01:20:00.780 --> 01:20:04.110
Erin Fratto: Always and say, do you want to do your though your senior director policy, no.

496
01:20:04.110 --> 01:20:04.770
Stephanie Arnold Pang: No, no.

497
01:20:06.390 --> 01:20:17.070
Erin Fratto: nose goes who's going to do it, so the the revenue is not subject to the same limitations, as the federal funds because its revenue from a pharmaceutical rebate.

498
01:20:17.790 --> 01:20:33.030
Erin Fratto: With That being said, part of being a 340 be provider means that you're reinvesting into your program so that means that your patient population needs syringes and you're going to be able to expand and continue STD prevention viral hepatitis prevention or.

499
01:20:33.540 --> 01:20:38.100
Erin Fratto: HIV prevention, then that is within the scope of the grant, and that is a reinvestment.

500
01:20:44.520 --> 01:20:55.200
Rebekah Horowitz (she/her): Another question to be eligible as a sub grantee does there have to be a financial exchange or can it be based on providing only support of in kind services.

501
01:20:56.460 --> 01:21:02.640
Stephanie Arnold Pang: Sure, to answer is, it can be only in kind, so in kind is considered a financial relationship.

502
01:21:03.660 --> 01:21:14.820
Stephanie Arnold Pang: So the you can receive in this either direct money or in kind in just a note is the in kind needs to be supported by the Federal grant so.

503
01:21:15.180 --> 01:21:21.630
Stephanie Arnold Pang: If you're if you're a local health department and you're receiving funds from the state, the State needs to be giving you money through a federal grant.

504
01:21:22.710 --> 01:21:35.100
Stephanie Arnold Pang: there's no minimum I would know kind of a gut check it probably probably not probably better to be more than what just you know $1 but you know it's some amount of federal funds, it can be supplemented by state funds or other funds.

505
01:21:35.520 --> 01:21:38.340
Stephanie Arnold Pang: But as be supported by federal grant if I federal grant.

506
01:21:39.990 --> 01:21:40.620
Stephanie Arnold Pang: and

507
01:21:41.850 --> 01:21:42.630
Stephanie Arnold Pang: and

508
01:21:44.160 --> 01:21:49.800
Stephanie Arnold Pang: Yes, so they could be purchasing as Aaron outlined a couple examples, supported by support testing at your state lab.

509
01:21:50.220 --> 01:21:52.500
Stephanie Arnold Pang: Providing you test kits they've purchased themselves.

510
01:21:52.920 --> 01:22:10.560
Stephanie Arnold Pang: If you're participating in a combined purchasing and distribution program you're receiving drugs purchased by partly federal funds through the state that's in kind contribution, so the receiving of those of those medication qualifies you so can just be just be in kind.

511
01:22:12.030 --> 01:22:24.930
Erin Fratto: yeah it sounds too good to be true, but it really is true, and that in pine contribution is very vague and it hasn't been updated or changed yet so that is that is what's in the policy that's what that's what's going right now.

512
01:22:26.280 --> 01:22:28.590
Rebekah Horowitz (she/her): yeah we don't want it to be clarified, really.

513
01:22:30.090 --> 01:22:31.350
Rebekah Horowitz (she/her): helpful but it's big.

514
01:22:32.430 --> 01:22:34.800
Rebekah Horowitz (she/her): So two questions, going back to the syringe.

515
01:22:36.690 --> 01:22:56.010
Rebekah Horowitz (she/her): Question i'm lauren has asked for clarification that you could reinvest those funds to directly purchase syringes in your opinion Aaron um and then is the syringe purchase info available anyway anywhere in an faq or anywhere else.

516
01:22:56.310 --> 01:23:08.340
Erin Fratto: yeah so it's not syringe specific, but there is language that there's no statutory regulatory obligation for revenue or income, so I can send that language i'll share that with you Rebecca that's.

517
01:23:08.850 --> 01:23:19.410
Erin Fratto: that's in policy but it doesn't say you know in bright red lettering like this means you can buy syringes but it just states that the regulatory authority does not extend to revenue.

518
01:23:22.560 --> 01:23:23.490
Rebekah Horowitz (she/her): perfect.

519
01:23:25.560 --> 01:23:27.690
Rebekah Horowitz (she/her): Yes, I will send that to everyone.

520
01:23:29.910 --> 01:23:33.540
Rebekah Horowitz (she/her): So if you folks have any last minute questions.

521
01:23:34.560 --> 01:23:36.450
Rebekah Horowitz (she/her): we've covered the ones that have been submitted.

522
01:23:36.750 --> 01:23:38.160
Erin Fratto: I just have one clarifying on.

523
01:23:39.570 --> 01:23:57.210
Erin Fratto: Which is HIV prevention, I do have that nofollow pulled up right now, and the statutory authority is section 318, so I will put that link to that no photo in the chat in case any of our HIV prevention friends were alarm that they are not 3040 be eligible anymore.

524
01:23:58.230 --> 01:24:09.030
Rebekah Horowitz (she/her): Great Thank you um so seen no additional questions, I want to thank Aaron and stephanie spin.

525
01:24:09.540 --> 01:24:24.420
Rebekah Horowitz (she/her): An awesome webinar this is people's contact information i'm Rebecca again, and then we have stephanie and aaron's contact information, you can call our cell phones, if you want to you can email us we're very friendly.

526
01:24:24.540 --> 01:24:26.160
Erin Fratto: I prefer text or means.

527
01:24:26.250 --> 01:24:26.460
don't.

528
01:24:27.720 --> 01:24:29.520
Rebekah Horowitz (she/her): You can send us funny video.

529
01:24:31.560 --> 01:24:40.020
Rebekah Horowitz (she/her): And I will be answering the listeners question, I will be sharing the slides and the recording as well as the.

530
01:24:41.760 --> 01:24:52.350
Rebekah Horowitz (she/her): The faqs that Aaron has mentioned and stephanie as mentioned, I will send all of that in in a follow up email as soon as the recording is posted on the website.

531
01:24:52.830 --> 01:25:00.030
Rebekah Horowitz (she/her): And again, you know feel free if you have questions to reach out to myself to reach out to stephanie to reach out to Aaron.

532
01:25:00.690 --> 01:25:09.930
Rebekah Horowitz (she/her): We are beyond thrilled to help you work through this stuff and you know recognize 340 be as a real opportunity and something that we should.

533
01:25:10.680 --> 01:25:22.860
Rebekah Horowitz (she/her): be talking about so you know, want to help people as much as possible to access the program um we'll leave it there, everyone enjoy your five minutes get a drink before your next meeting.

534
01:25:24.900 --> 01:25:26.400
Stephanie Arnold Pang: Great to be with you take care, everybody.