The 3 Ps of the 340b drug Program: Participation, Pricing, and Program Integrity August 14, 2012 1: 30 pm et
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| Recertification will occur in January when the authorizing official for your center receives an email from us with the user name and password. The authorizing official will recertify for all child sites and contract pharmacies.
Next slide, recertification steps continued, the goal is to make the recertification process very smooth. The authorizing officials should only have to verify the information in the database, click the button and submit it to OPA when the time comes. There should be no question about the information he or she verifies when they're logging in with the user name and password. This is truly a time when preparation will prevent headaches and delay on the backend. You should have plenty of time to ensure your center's information matches in the EHB's. And at any time between now and January don't hesitate to give us, PSSC or Prime Vendor a call. After the authorizing official submits the recertification OPA will verify it by matching it with EHB's. After OPA certifies the information the authorizing official will get an email notification that the center has successful recertified. Next slide -- so here's a recap of the important steps in recertification. Update all information in the 340B Program database prior to recertification. I strongly urge you to do this early. You can start today if you like. Alert your authorizing official that recertification is coming, that OPA will send informational emails over the next couple of months. There are resources and places you can turn to, to ask questions, PSSC and PVP. And remember change forms update in 340B database record and recertification is a separate step that will occur in January. The last two slides -- in addition to verifying center information your authorizing official will attest to the items on the next two slides. These are things that the centers are responsible for from the first day they begin participating in the 340B Program. The authorizing official will attest that the center meets all eligibility requirements that the center is complying with all program requirements, that the center has processes in place to ensure compliance and that records are kept. So these are things that you should understand and know that are going on in your center, should have been going on from day one. And hopefully there are no surprises. That is my part for today's webinar. I will now turn it back to Commander Pedley to finish up. Commander Pedley? Krista Pedley: Thank you JT. We also want to apologize. We do recognize that there's been an issue with audio. And we're doing everything that we can to update it. Remember that this will be recorded. If you can please follow along with the printed slides. But again we're doing everything we can and we apologize. So on program integrity and recertification, since the September 2011 GAO report -- and for those of you not familiar with that report it's on the OPA Web site regarding the 340B Program -- HRSA has enhanced existing oversight activities and initiated new oversight including audit and recertification as you just heard about through use of available resources. Our oversight focuses on three major areas. That's eligibility, restriction to outpatients and the prohibition on duplicate discounts. We take all allegations regarding compliance very seriously and we follow up on each and every allegation directly with the entity if we've received any type of allegation. So on Slide 22 and 23 we talk about the two prohibitions in the program. The first is diversion. Diversion is when a drug is provided to an individual who is not a patient for purposes of 340B. Many of you in your questions asked about what is the current guidance on patient definition in the 340B program. The current guidance is our 1996 guidance which you can find on our Web site. We did propose new guidance in 2007, but those were never finalized. So the 1996 version is what still should be followed. HRSA is in the process of revising those guidelines. And you will be seeing those in the near future about what it means to be a patient. On Slide 23 we talk about the duplicate discount prohibition. A duplicate discount occurs when someone accesses the 340B discount on a drug and it also - a Medicaid rebate is received on that same drug. Safety net providers have a choice of whether they will use 340B drugs for their Medicaid patients or not. If you use 340B drugs for your Medicaid patients that's known as a carve-in model. If you decide not to use 340B drugs for your Medicaid patients that's known as a carve-out model. Regardless you need to inform the Office of Pharmacy Affairs of how you are billing for your Medicaid patients. And that should be outlined on our Medicaid Exclusion File. It's very important that the Medicaid Exclusion File on our Web site outlines exactly how you are billing because if you are audited that's the first thing that we'll check, is to make sure that how you reflect on our database is what you're doing in practice. The reason for that is that states and manufacturers use are database to know whether a covered entity is using 340B drugs for its medication - Medicaid patients in order to avoid duplicate discounts. So it's not just for you in order to prevent duplicate discounts, but it helps the states and the manufacturers as well. So please make sure you have that information up to date. And if it is not accurate please submit a change request that JT had talked about to update that information. On Slide 24 we talk about our current activities around program integrity. Determination of eligibility -- we review this on a quarterly basis to ensure entities remain with their grant status. Annual recertification which is a brand new process that we are starting with health centers this year -- we have recertified other entities in the past. We just completed hospitals. And as again JT mentioned the FQHCs will be going through this for the first time. And you'll be seeing emails and additional webinars from us on this process. I saw a question come through about is there a need to enroll every year. There is not. Once you enroll in the program you remain in the program. And that's separate from the annual recertification process where you have to annually update your information on the database and certify to all the compliance requirements. So those processes are separate. We also do quarterly calculations of the 340B prices. We maintain the Medicaid Exclusion File that I discussed. We investigate every allegation we receive against an entity and/or manufacturer if they are out of compliance. And we also provide technical assistance, webinars, FAQs and guidances on program requirements. Slide 25 outlines some of the newer elements that we've been publishing regarding compliance. And you can find these on our new Program Integrity page on our Web site. The first is the penny pricing policy which defines for a manufacturer that if they're ceiling price calculates to a zero that they charge a penny for that product. And you can see that policy release. There's a non-discrimination policy by which manufacturers cannot discriminate against a 340B entity in providing medications. They have to provide medications to 340B entities and non-340B entities in a fair manner. Manufacturer audits -- manufacturers also have the authority to audit covered entities and we outline those policies in that policy release. And then the covered entity audits in which HRSA's currently conducting -- that's on our Web site. Accountable Care Organization and then the Medicaid Exclusion File and hospital eligibility requirements are still being worked on. Stay tuned to our Web site for more information on that. So besides our re-cert activity as I mentioned we are also doing audits. We are incorporating questions into the A-133 process and to the project officer site visit. So that's what I'm going to discuss next. So if you go to Slide 26 HRSA is currently in the process of conducting audits for the first time of 340B-covered entities. In fiscal year 2012 we will have completed 51 audits. We are doing audits both on a random basis based on a risk stratification in addition to target audits where we receive specific information of an entity that's in violation of the program. There are health centers included in these audit processes. So please make sure and prepare your site for any type of audit. We have published a one-pager on our Web site on the Program Integrity page that outlines what you can expect from one of our audits. This is something that we want to be very transparent about so that we can appropriately prepare your site. We - there's no hidden agendas. We just want to make sure that everyone is following all of our guidelines. And really the purpose of these audits are to help the entities and the 340B community come into compliance and for us to be able to create tools and resources that will help all covered entities based on our findings. You'll see here the focus areas of the audits include eligibility, policies and procedures around procurement, inventory, dispensing and billing, the internal controls, issues with diversion and duplicate discounts. It's very important as well that you have written policies and procedures in place regarding your 340B processes as one of the first questions that the auditors will ask on site is to be able to see the policies and procedures you have in place to ensure against diversion and duplicate discounts. The next slide on Slide 27 outlines the manufacturer process to conduct audits. Again manufacturers have always had the authority to audit, but for the first time this year has actually been undergoing audits of covered entities. Manufacturers, unlike HRSA, have to actually establish reasonable cause prior to auditing a covered entity. They submit an audit work plan to the Office of Pharmacy Affairs that outlines their reasonable cause and what their plan is for going on site. And there's a federal register notice that outlines what a work plan has to include so both covered entities and manufacturers can understand what that process is. The manufacturer audits are limited to diversion and duplicate discounts. And manufacturers are not allowed to audit eligibility issues. That's only within HRSA's purview. And OPA actually does encourage manufacturers to submit plans for audits as well as we see everyone is responsible for compliance in the program. So again these audits are in process by the manufacturers. On Slide 28 we start to - so the first problem was our audit. The second is the A-133 process. For the first time 340B questions have been added to the A-133 compliance supplement which is now publicly available. So this will be conducted beginning in fiscal year '13. You can go online to see the types of questions that will be asked. The purpose of the A-133 audit and the site visits that are going to start for entities are really a way just to flag where there may be issues so that the Office of Pharmacy Affairs can further follow up. For example there's going to be questions like, "Do you have policies and procedures in place? Is your information up to date? And do you have procedures in place to ensure against diversion and duplicate discounts?" So really the A-133 process and the site visits are a way for us to gain a better understanding initially of what type of efforts are going on in your site regarding compliance. And please remember that there are tools available to you that we will be discussing here in our next round. So with that we actually have a polling question for you. And the question is, "Are you aware of the 340B peer-to-peer program?" And click Yes or No of whether you're familiar with this program. So thank you for responding. We're getting great numbers. It looks like many of you are familiar, but many of you are not familiar. And this is one of the tools that are available to you. This is a way for best practice sites to share operationally how they implement the 340B Program. I'd like to now turn it over to Bob Brown who's one of our peer-to-peer sites and works very closely with the Office of Pharmacy Affairs. He's a pharmacy manager at Travis County Health Care District Texas Community Health Centers. And he's going to talk a little bit about the peer-to-peer program and his role. So Bob I'd like to turn it over to you. Bob Brown: Thank you Krista. The peer-to-peer program began a little over a year ago. We were fortunate to be picked as one of the sites to be included. And what does it mean to be a peer? It's really a willingness to share your best practices within your entity. The - we each agreed to contribute sometime each month on behalf of the program. And following the mantra of the patient safety collaborative it's really all-teach-all-learn. We've used our stipend that's mentioned here to offset the cost of travel and per diem in recruiting our first PGY2 resident in cooperation with the University of Texas College of Pharmacy. That resident began their rotation last month, July of 2012. (Community cares) participation in peer-to-peer has really focused on our local experience with the contracted pharmacy process, the roles of the various vendors that we use. And our process is used for internal audits and with external vendors. We've shared with other entities our request for vendor proposals, our contract pharmacy relationships and fee structures. And we've shared information detailing the duties and obligations of all parties to our contracts. Other peer-to-peer mentors have variously described their services and we've learned from their experience. The Apexus 340B University has been a benefit to me as a faculty member and for our community care staff who have attended those sessions. The next slide please. The peer-to-peer -- it's a collaborative effort among covered entities to share 340B policy interpretation and guidance, program knowledge and experiences as well as practical and technical expertise. We have provided webinars throughout the year and we've covered various models of pharmacy services in-house, contracted, mixed-use settings and hospital outpatient services. The next webinar in the series is described here on this slide. Both the webinars and the national seminars have focused on how-to, very practical -- practical advice provided on a range of topics against the backdrop of existing 340B policy. There are various tools available for building blocks for your program to achieve integrity. These are found on the health care community's Web site and on the Apexus Web site. And if you haven't I would encourage everyone to attend the 340B University at your earliest opportunity. It's an excellent experience. And as I said we've all benefitted from it and we've learned from other faculty members about their best practices there also. Thank you. Krista Pedley: Thank you Bob for sharing your experience with the peer-to-peer program. I do encourage you to participate in those sessions to help you operationalize the 340B Program and to hear it from your peers. So if we go to the next slide I'd like to take a moment to talk also about one of OPA's initiatives, the Patient Safety and Clinical Pharmacy Services Collaborative which really ties together 340B medication access with safe med use systems. We have a responsibility to ensure medications that patients receive are in a safe environment. This collaborative is a quality improvement effort aimed at improving health outcomes and patient safety driven by community-based organizations and inter-professional teams. There's over 200 plus teams that participate in this program, many of them being health centers as natural health homes in this process. We're starting in our fifth year this fall which we're very excited about in partnership with CMS and the quality improvement organizations. To learn to sign up for this effort you can see the web link on the page here. You could also go to our Web site at hrsa.gov/opa to find out more information on how to join this effort. So the next two slides actually talk about our resources. And the first thing I'd like to do is actually again we want to poll you to understand which of the following 340B resources have you used for technical assistance -- HRSA Office of Pharmacy Affairs, HRSA's Pharmacy Services Support Center, 340B Prime Vendor Program? So it looks like many of you are using our resources, which is great. And I'm now going to go into detail more about the Pharmacy Services Support Center and the Prime Vendor Program which are two contractors that HRSA Office of Pharmacy Affairs has to help entities and provide them assistance. So the Pharmacy Services Support Center is a contract that we have with the American Pharmacist Association to provide free technical assistance to 340B-covered entities. They have a call center to help you answer basic questions. They assist with program development, information and analysis, relationships and networking by attending different webinars and going to meetings across the country. And as we had already discussed they run the peer-to-peer learning network by which you can all be involved in. And we have a slide on the last page on how to get involved. The next slide talks about our second contractor which is the 340B Prime Vendor Program. This is a no-cost contract with Apexus to provide a drug negotiation at sub-ceiling prices to covered entities. Once you join the 340B Program through the Office of Pharmacy Affairs you can then join the Prime Vendor Program in order to receive sub-ceiling discounts on your medication. The 340B Prime Vendor Program also has a 340B University. And you can go to their Web site to find out more information on this educational opportunity to really provide to you a day session on OPA's policies and how to operationalize those policies. The Apexus 340B Program also has a call center to provide free technical assistance to the 340B covered entities. I encourage you to visit both the PSSC and the Prime Vendor Web sites. The last slide here really just puts on one page all of our resources that are available to you. I encourage your to utilize them in order to gain more information. With that we're going to open it up for questions. And as the operator informs you all on how to do that I'm going to address some questions we've been getting through the internet. So if Operator you could please instruct on how folks can ask questions? Coordinator: Once again on the phone lines it's star 1 to ask a question. Krista Pedley: Thanks. A few of the questions I'd like to address -- one is, "When are the audit findings expected to be made public?" At this time all the audit findings are preliminary. We're hopeful that we'll be able to get through those audit findings in the next few months. We are going to make the audit findings public on our Program Integrity page on our Web site. So we encourage you to continue to monitor that Web site. We also got a question about does a contract have to be signed with a pharmacy in order to be listed on our Web site. The answer to that is yes. You cannot submit or enroll a contract pharmacy until you have a written contract in place for them to be listed on our database. We also have a question about can you confirm self-certification deadlines for contract pharmacies. The covered entity is ultimately responsible for their contract pharmacies that they have registered. We are not separately certifying contract pharmacies. But through the annual recertification process you will have to attest to the compliance of a contract pharmacy. As a reminder (as well as) a covered entity's responsibility, not just through re-cert, but to constantly inform OPA if there are any changes that you need to make -- or if you do have a compliance issue to disclose that to the office. So with that if we could open it up and have the first call, the first question. Coordinator: Our first question comes from Marijka Lampard. Your line is open. Marijka Lampard: Yes good afternoon. Thank you for this presentation. I have a business called HPSA Acumen. We work on health professional shortage area designations. And I'm wondering if the requirement across the board is for these facilities to be in an area HPSA or a medically underserved area or medically underserved population. And the second question would be would a rural health clinic qualify. Thank you. Krista Pedley: On your second question about whether a rural health clinic quality it depends on whether they would otherwise meet one of the eligibility requirements and actually receive a grant from one of the entities that are eligible. For example if they receive a 330 grant then they would be eligible. So it really does depend on whether they would otherwise meet because they in and of themselves are not eligible. They would have to fall under one of the other eligibility requirements. Marijka Lampard: I see. Krista Pedley: In terms of your first question I'm not familiar with that. I believe that question's outside of the 340B Program. Man: Yes so to be part of the 330 Program... ((Crosstalk)) Man: Go ahead. Woman: But in general if you're going to receive funding under 330 you would have to be in a medically underserved area. Man: Right. Woman: Is that answering your question? Marijka Lampard: That would answer my question -- thank you -- if that is true, yes. Man: Yes this is true. Marijka Lampard: Thank you. Coordinator: Our next question... Krista Pedley: Next question? Coordinator: Our - the next question is (Lucinda del Sarto). Your line is open. (Lucinda del Sarto): Hello. Can you please tell me what will be the auditing periods, the years that we'll be audited? Krista Pedley: That's going to actually depend on when the audit would occur. It actually has been a (look-back) and it's for usually about six-month time period. So it would really depend on when you're actually audit - if you were audited when it would be scheduled. But it's sometime in the previous year for a six-month period. (Lucinda del Sarto): Perfect. Thank you. Coordinator: The next question comes from (Monica Oban). (Monica Oban): Hi. Good afternoon. I wanted to ask a question regarding our pharmacy. If we have - if the pharmacy is owned or a part of the FQHC center does there need to be a contract in place? We are a part of the clinic, the pharmacy. So I heard you mention something about the - a contract between the - a contract pharmacy and the health center. But what if the pharmacy is owned by the center? We are employees of the center. Krista Pedley: If it's owned by then you do not need a contract pharmacy in place. So there's two models to dispense 340B medications. There's what's known as an in-house pharmacy. So the health center would own it and then you would be listed as what's known as a ship-to address... (Monica Oban): Okay. Krista Pedley: ...on our Web site. But if the - a health center doesn't have a pharmacy or even if it has a pharmacy and wants to provide services outside that pharmacy they would contract with an organization outside to provide those pharmacy services. Those need to be registered on our Web site and enrolled. (Monica Oban): Okay. Thank you. Coordinator: Our next question comes from (Chervanday Avilaby). (Chervanday Avilaby): Hello. I just have two questions. One is can you contract with more than one pharmacy. And then the second question is is there a template available for contract pharmacy services? Krista Pedley: You can contract with more than one pharmacy. In March 2010 we published a new guideline called Multiple-Contract Pharmacies where for the first time you can contract with more than one pharmacy. And that guidance is on our Web site. Download 207.04 Kb. Share with your friends:
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