The 3 Ps of the 340b drug Program: Participation, Pricing, and Program Integrity August 14, 2012 1: 30 pm et
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The 3 Ps of the 340B Drug Program: Participation, Pricing, and Program Integrity August 14, 2012 1:30 pm ET Coordinator: Good afternoon and thank you for standing by. All participants will be able to listen only until the question-and-answer session. At that time to ask a question you may press star 1. This conference is being recorded. If you have any objections you may disconnect at this time. I would now like to turn the call over to Desha Anderson. You may begin. Desha Anderson: Thank you. Good afternoon and welcome to our Grantee Enrichment call today on the 3 Ps of the 340B Drug Program: Pricing, Participation and Program Integrity. Before we get started I have a few housekeeping notes that I would like to share. The first thing is that the presentation -- if you haven't had a chance to download it from the TA Web site you can currently download it from the left. On the left-hand side there's a box that says Presentation Materials. If you click on the file name there - the button should highlight that says Save to My Computer. If you do that you'll be able to download and save a copy of the actual presentation. The next thing I would like to bring your attention to is that there is a closed caption pod at the bottom of the screen. If you don't need it there should be an option where you can turn it off and turn it back on. Also if you would like to enlarge the viewing screen during the presentation there will be a button at the top that will say Full Screen. If you click that you can enlarge your view. And if you want to revert back to the regular viewing screen you just push the same button and it'll take you back. There will be a few polling questions that will appear on the screen throughout the presentation. We do encourage everyone to please participate in those. Your interaction is very much appreciated. And we already see that most of you have participated in the two polling questions over to the bottom left. If you haven't had a chance to do so please go ahead and select your answers on those with the first one being choosing organization type. And the one that's right below it is, "Are you currently participating in the 340B Program?" And the next thing is that for the question-and-answer section of this call today the Q&A will take place at the end of the presentation. However please note that you will get a chance to submit your questions during the presentation. When we switch to the presentation screen you will see a box that'll say Submit Questions Here. So we appreciate that. And we will try to answer them, integrate them into the discussion as we're moving along. And now I would like to turn over this part of the call to Ellen Czeh who is the Branch Chief of the Development and Coordination Branch in the Office of Training and Technical Assistance Coordination. Ellen? Ellen Czeh: Thank you Desha. Hello. Welcome to today's Grantee Enrichment Webinar on the 340B Drug Pricing Program brought to you by the Health Resources and Services Administration Bureau of Primary Health Care Office of Policy and Program Development in collaboration with the HRSA Health Systems Bureau Office of Pharmacy Affairs with 100 plus programs and over 3000 grantees of the Health Resources and Services Administration reaching to every corner of America providing an essential safety net of direct healthcare services used by tens of millions of Americans who are uninsured, isolated or medically vulnerable. The mission of the Bureau of Primary Health Care which is carried out in particularly through the health center program is to improve the (unintelligible) underserved communities and vulnerable populations by assuring access to comprehensive, culturally confident quality primary healthcare services. Comprehensive pharmacy services is one of the many areas critical to achieving the mission in terms of improving the health status of communities and patients served by health centers and eliminating disparities and access to health care. Excuse me. Inadequate access to affordable pharmaceutical and appropriate pharmacy services often leads to problems with drug interactions, inappropriate doses and failures to adhere to prescribed therapy. This is why we are particularly pleased to note that in calendar year 2011 nearly 3000 pharmacy personnel provided crucial services to patients at health centers and 85% of health centers are providing pharmacy services either onsite directly by the health center or through formal written contracts or agreements with other providers. One of the key drivers of this significant pharmacy activity across health centers as well as the ability of health center patients to access affordable medications is a participation of health centers in the 340B Drug Pricing Program. Through this program they can purchase prescription medication at significantly reduced prices and can also access technical assistance on innovative pharmacy services delivering models. Health center quality of care equals and often surpasses that provided by other primary care providers. A programmatic emphasis on quality as well as on providing comprehensive community responses and culturally appropriate care has also translated into impressive reductions in health disparities for health center patients. These achievements are even more notable given that the health center patient population is often sicker and more at risk than the patient population seen nationally. To illustrate how critically - how critical pharmacy services are in supporting the delivery of high-quality patient-centered primary care and improving health outcomes in particular for chronic conditions, I'd like to highlight a couple of areas with calendar year 2011 health center program data. For example nearly 53% of adult patients that were identified as tobacco users received tobacco cessation intervention. If tobacco users are provided with an effective mix of counseling and pharmacologic intervention they will then be more likely to quit smoking and they therefore have a lower incidence of cancer, asthma, emphysema and other tobacco-related illnesses. Another example is 69% of health center patients, both children and adults, received appropriate pharmacological treatment for asthma. Patients identified with persistent asthma that are provided with appropriate pharmacological intervention by their health center will be less likely to have asthma attacks, will require fewer emergency room visits and be less likely to develop complications related to asthma including death. Therefore we are proud of the progress we have made together with the hard work of our health centers and partners. As we move forward the Bureau of Primary Health Care is committed to providing forums such as this webinar to hear from experts and other health center grantees and have success - who have successfully implemented programs such as the 340B Drug Program at their health centers. We hope that you find this webinar informative and encourage each of you to actively participate in the polling questions as well as the Q&A session that will take place at the end of the presentation. Today our guest speakers will be our colleagues from the Health System Bureau Office of Pharmacy Affairs -- Commander Krista Pedley, the director of Office of Pharmacy Affairs, and Commander James Morris, the branch chief of the Office's Operations Branch. We are also pleased to have Bob Brown, the pharmacy manager of Central Texas Community Health Centers, on our call to talk about his experience with the 340B Drug Program. At this time I'll turn the call over to Commander Pedley. Krista Pedley: Thank you. And thank you for having us today. We're excited to be here to talk about the 340B Program. HRSA's committed to ensuring that the 340B Program, the 340B covered entities that participate and participating manufacturers are in compliance with program requirements. And we hope that by the end of the day today that we'll be able to update you on our program integrity effort. Before we move on with our presentation I'd like to stop and get your feedback on what are some things that you would like clarification on regarding the 340B Program. And you can go ahead and complete the polling exercise so that we can gain your feedback and hopefully integrate what you'd like to hear about throughout the presentation. If we don't address your concerns, at the end of the presentation we'll have resources that will be available to you. So again what are some of the things that you would like clarification on regarding the 340B Program? So it looks like we're getting some things about recertification which we will address. We will talk about the basics. It looks like definition of a patient is there which we can touch on, what resources are available. So it looks like it'll be right in line with where we're headed today. So if we go to the next slide these are some of our learning objectives for the day. We're going to identify the requirements to participate in the program -- and by looking at the initial poll it looks like many of the grantees are actually participating in the program, so that was great to see -- understanding the requirements of the recertification process, become familiar with the new site visit and audit requirements and for us to be able to identify the tools and resources that are available to you. Next slide please. The mission of the Office of Pharmacy Affairs is to promote access to clinically and cost-effective pharmacy services. And we do that through the 340B Program which assists entities in providing access to medications for their most vulnerable patients in addition to ensuring that they provide quality care at their sites through our patient safety collaborative. The next slide really addresses the overview of the program. 340B Program provides discounts on outpatient drugs to certain safety-net covered entities. The 340B Program ceiling price is defined in this statute. This is clearly only an outpatient program. And the safety net entities that are able to participate are also defined by statute including health centers and the look-alikes. There's an average savings of 25% to 50% -- so tremendous benefit from the program for participating. And those savings may be used to reduce the price of pharmaceuticals for their patients, to expand services and to provide services to more patients. There's an estimated 6 billion in purchases in the 340B Program. And manufacturers that participate in Medicaid must also participate in the 340B Program and provide discounts on the much needed medications. For the next slide it's very important to understand to the intent of the program. And that is to permit eligible safety net providers to stretch their scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. 340B Program is a tremendous benefit to safety net and its patients. But we also want to caution you that it does have some risk by you accepting the responsibility for compliance when you enroll into the program. We want those that participate to be in compliance and we want you to understand the tools and resources that are available to you to ensure compliance. So with that I'd like to turn it over to James Morris who's the Operations Branch chief in the Office of Pharmacy Affairs who's going to discuss participation requirements and recertification. JT? James Morris: Thank you Krista and good afternoon everybody. As Krista said I'm Commander JT Morris. I'm the Operations Branch chief in the Office of Pharmacy Affairs. The Operations Branch is responsible for reviewing all of the registrations that come into the program to ensure eligibility for those who are enrolling in the program. We are kind of the - in a way the front door of the program. And today I'm going to be talking about enrolling, participating and recertifying in the program. And when I am done I will return the presentation back to Krista and she will finish up. So just a quick little bit of background -- there's 22 entity types that are eligible for the program. Here on the slide you can see the larger buckets of the eligible entities. We see them as two different types. We have federal grantees and we have hospital types. As BPHC grantees you naturally fall into the federal grantees column here. There are other eligible HRSA grantees such as the hemophilia treatment centers that we see funding through the MCHB, or Maternal Child Health Bureau. We have Indian health service grantees. We also have CDC grantees that are eligible. Those would be the sexually transmitted diseases and tuberculosis clinics that are funded through CDC. Last but not least there are family planning clinics that receive Title X funding from the Office of Population Affairs under the assistant secretary of health. So let's see. The program has been around for 20 years and we just provided the reference to the 340B law here that references - or it gives you - or this is the reference that makes the health centers eligible for the program. So if you're interested you can go visit that. It's fairly short, but it does make you eligible for the program. So as - moving on to the next slide for 340B enrollment steps, so we'll talk a little bit about eligibility -- or we talked a little bit about eligibility. So let me switch a little bit and move on to enrollment. There are four main steps to enrolling in the program. The first is determining eligibility. It's not always cut and dry or clear when determining if you're eligible for the program or not. So I would suggest, strongly suggest, that you visit the - our web page first. Read through that. See if that makes you eligible for - or it's clear to you that you're eligible for the program. And if you are unsure I would suggest that you contact the Pharmacy Services Support Center or the Prime Vendor who are two contractors with us that do a great job of providing assistance to those who are looking into the program or are participants of the program. So after you - let me go back. We now accept only online registrations. Some who are on the phone now and listening may have submitted a paper registration in the past. We are moving forward with our technology and we only accept online registrations. And the nice thing about it is it only takes about five minutes. It's a fairly short registration form and you should be able to get through it pretty quickly. Again if you have any questions about the registration you can contact the Pharmacy Services Support Center or the Prime Vendor or even call OPA. So after registering OPA will verify that the community health centers are eligible by using the HRSA EHBs. Please note that OPA will not approve registrations that do not exactly match the EHBs. All of the information must be the same. We're checking every dot over an I and every T. That's important for the integrity of the - our program, but it's also important to the manufacturers and wholesalers that you will be working with in the future. They will be using the database that we keep as the source of truth. Please keep in mind we have thousands of registrants in our database. It - and therefore it is the entity's responsibility to keep the database records up to date at all times. Please work with your HRSA project officers and grant managers to keep the EHBs updated. This will be important for upcoming recertification which I will talk about in a few minutes. After OPA verifies the information the entity will be notified and they'll let you know that you've been approved. And we'll give you the start date and your 340B ID number. You'll receive all that information through an email once we have approved your registration. On to the next slide, 340B enrollment, we are - this is new. Again I just want to emphasize that this is new for us. We are changing our enrollment periods. You can - we will begin October 1 coming up, October 1, 2012. Like I said this is a new process which starts this upcoming October. No longer will the entities have roughly three months to register. We will only accept registrations during the two-week windows that you see there on the slide. In the table you can see there's the two-week periods and the associated start date. The start dates have not changed. We always start at the beginning of each quarter. We are only changing the enrollment period. Registrations received outside of the listed periods will not be considered. And we will let you know if for some reason those will not be considered. We'll give you a brief, kind email. For instance if the - this upcoming quarter has a start date of January 1, 2013. And I say updated quarter, not the one we're in now, the one starting October 1. We will accept registrations between October 1 and October 15. You should know by the middle of the end of November -- by the middle or the end of November -- if you have been approved to start on January 1. On a related note OPA is now accepting online change requests. It is the participating entities' responsibility to complete the change request any time a change occurs at the health center, be it an address change, contact information and/or your Medicaid billing practice. All of these should be reported as soon as possible to 340B using the change request. And we'll give you a web page here soon where you can find that change request form. It's important because manufacturers and wholesalers follow the database closely and will not extend 340B pricing unless the 340B database is correct. Okay. After the health center is approved -- we're moving on to the next slide, 340B enrollment -- after the health center is approved to participate in the program I urge you to contact your drug wholesalers to establish their 340B accounts. They - the wholesalers will need your 340B ID number. You will receive that 340B ID number in your welcome email that comes from the 340B program. Implementation of your 340B program can be complicated, but we have some good resources to help you. Pharmacy Services Support Center and the Prime Vendor are great sources of information. You will find online resources to help you get started. You can talk to someone with 340B and there is a peer-to-peer network established so you can learn from the real world. And we're going to hear from Mr. Brown earlier as he - as a great example of how the peer group network works. OPA recognizes that providing access to drugs for your patients is very important. If you want to provide greater access to 340B drugs to your patients you can contract with pharmacies in your local area to make it easier for your patients to receive their drugs. Just so I can give everybody on the phone a heads up for some reason I've lost connectivity, but I have the slides in front of me. So I'll keep going. It's important to remember that your health centers are responsible for ensuring that all the eligible patients get the 340B drugs. Your health center is solely responsible for the contract and ensuring that all the contracts meet 340B program guidance and follow the law. Drugs can be shipped to the contract pharmacies, but the health center must order and pay for the drugs using their 340B ID number. If you have questions about the contract pharmacies or any of this we can talk and you can ask questions as we move forward. Okay so I'm moving on to the next slide, the 340B database slide. So now the health center's been enrolled. You've notified your wholesalers that you're approved to participate and you're eligible to receive the 340B program benefits. There is some responsibility that comes with the benefits. And this is an important time in the participation of the program. 340B Program maintains the 340B database which is the source of truth. So the wholesalers will use this database every day to verify eligibility of the participating entities. If the information in the database is different than what you provide them they will consider you ineligible for the program and not ship drugs to the health center. This is why it's important for your HRSA scope of grant to be up to date at all times. And the 340B Program cannot change the database until - cannot change the 340B database until it matches with the EHBs. If you already participate in the program and want to change information about your center we now offer an online change request form which I mentioned earlier. And this is a simple form for you to use. And hopefully on the screen you can see the web page where you can access the registration and access the online change form. Moving on to the next slide for recertification, I talked about the enrollment process. There was briefly talk about what you do once approved or have been in the program for a while. Now I'm going to change gears a little bit and talk about your annual responsibilities for recertification. Passage of the Affordability Care Act of 2010 changed our program responsibilities and the responsibilities of the Affordability Care Act - of the -- I'm sorry -- changed the responsibilities of the participating entities. We are now required to annually recertify that all participating entities' information in the database is correct. Through recertification we will be improving program integrity and compliance with the program and thus making us all more accountable for the program. You've heard us say this before, but we cannot stress it enough. It is the covered entity's responsibility to ensure that your record in the database is up to date. For health centers it much match exactly what's in the EHBs. Please double-check the database often to make sure your record accurately reflects your center information. Moving on to the next slide, recertification implementation -- so we have been doing a certain level of recertification in the past. Before ACA we were doing this. For health centers we checked on a quarterly basis to ensure that the database matched the EHBs and we were fairly - pretty successful with that. After ACA we implemented a full recertification program for all entities participating in the program. This is a big effort and we are approaching it in phases. And you can see we have already recertified the Ryan White Programs, STD and TB. We've gone through one round with the family planning. Hospitals we just completed. That was a big effort. And we'll (be getting) with the health centers this winter and - late fall and early winter. And this is new to the health centers and new to us. We will provide support and guidance throughout the process. So let's talk a little bit about the process. I've gone on to the next slide, 340B recertification steps. Bullet number one is key to ensure a smooth recertification for you and for us. It's to make sure your information in the database is up to date and matches what's in EHB's. We will help with bullet number one by doing the following. There is a two-step process in recertification. First it's updating the record in the database. Number two is the actual recertification. And we will help with both by doing the following. We'll support your efforts this way. In November we will send an informational email with information about recertification introducing the process through the authorizing official in the database for your entity. In December you will get another email with more details about what to expect when the process starts. During November and December both emails will strongly encourage you to update your records in the 340B database. You don't have to wait until November or December. I would strongly encourage you to go today once this webinar is over and check your 340B database record. If there's anything in there that is different than what you have now, access to the online change request form and submit it to the office. Download 207.04 Kb. Share with your friends:
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