340B Program Recertification For All 340B Hospitals

The OPA is requiring all 340B sites to recertify this year

Before I get into this topic, I have to mention the craziest thing that happened today. First, to be fair to our health system, we do not mention it by name. I do feel it is a great health-system, but since we have created this site as a personal endeavor, we have decided to keep things separate. I do not even mention this blog at work, I do my best to keep things professional and focus on my work of leading and managing a large hospital pharmacy staff. However, I had an experience today that made me realize that sometimes things cannot always be kept separate.

Here is what happened: We had some realignment and my boss changed. My hospital brought in a new operations officer. I was able to meet him today and we had a great discussion that ended up on 340B. He had some experience at another facility with 340B and we were sharing ideas and plans for the future. At some point, he mentions that he has read a 340B blog written by a pharmacy director. Can I just say, I was sort of speechless. He shows me the blog, and we pull up this one (what are the chances?). I confess to my extracurricular activities (all on my own time for the record). So, if you are reading this . . . Hi Kevin, I look forward to working with you and am ecstatic that you already have a solid foundation on 340B.

Okay, I had to share that, but on to the OPA recertification for 2012. If you are a 340B hospital, you will need to recertify that you qualify to participate in April. We have been asked to update our hospital information and make sure it is all correct by March 1st (yes, in less than 1 week from today). Here is a link to the OPA page to update your information: OPA Information Change Form. In April, the OPA will send emails to “Authorizing Officials” of 340B hospital entities (for me, that is my CFO). The email will contain “username, password, and recertification instructions.” The OPA is having a conference call on February 28th to cover this topic, which I strongly recommend you call in to (unless of course you are reading this after the fact). To sign up for the webinar, click here. You may also call in by dialing (888) 790-9118 (conference # PW1880597 and participant pass code is 340B).

In addition, the OPA posted a letter from the HRSA director on their website yesterday that outlines 340B integrity efforts. Here is a link to the letter: HRSA Letter. The letter discusses the current audits (I heard through the grape vine that they are randomly auditing about 8 covered entities a month, 2 being DSH hospitals; in addition to covered entities who have suspected diversion). The letter also discusses efforts to verify (recertify) covered entities.

Okay, that is all I have. I’ll be at the 340B conference next week in San Diego, I hope to see you there. -Rob

340B Audits Are Here!

 

The Patient Protection and Affordable Care Act (PPACA) mandated that GAO address questions related to the 340B program. GAO examined: (1) the extent to which covered entities generate 340B revenue, factors that affect revenue generation, and how they use the program; (2) how manufacturers’ distribution of drugs at 340B prices affects covered entities’ or non-340B providers’ access to drugs; and (3) HRSA’s oversight of the 340B program.1

 

After the GAO report was published, GAO recommended 4 main issues to HRSA to resolve and understand:

  1. Conduct selective audits to deter potential diversion.
  2. Provide a more specific definition of a “patient”.
  3. Issue eligibility guidance to hospitals that are not publicly owned.
  4. Further specify 340B nondiscrimination policies for distribution restriction.

 

What is our company doing? 

  • Reviewing our 340B policies and procedures.
  • Tightening up our audit procedures.
  • Preparing pharmacy directors on expectations of an audit.
  • Gathering all appropriate documents (cost reports, Medicaid exclusion documents, DSH% reports, contracts, audit reports), and centralizing to one Team Space location.

 

We are hoping to gain some more insight to the audit process at the Winter Conference in San Diego later this month.  Oh yeah, and warm weather!

 

1 GAO-11-836 – Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement

340B Winter Conference Update

Update: The Rich’s will be at the conference for sure. I have my plane ticket and am registered, however, there is a high likelihood that our friends of The Joint Commission will be surveying my hospital that week. If they do, I will need to send my pharmacy resident in my place. Still, I hope to see you there!

340B Program Used for Charity Care

Another Example of how we are using the 340B program to expand and increase charity care.

340B Program
As a 340B covered entity, we continually look for ways we can expand and increase charity care for our patients with need. Here is another example.

My 340B DSH hospital has a diabetes clinic. In many cases, we try and work with our hospital based clinics (defined as being on your Medicare Cost Report) to understand 340B and how it can help offset the cost of healthcare to our disproportionate share of Medicaid and Medicare/SSSI patients. Not to mention our already large amount of charity care we provide to patients who simply cannot afford their healthcare cost. Our medical director at this clinic wondered how this benefits his patients specifically, and I did not have a good answer. We talked about this and went ahead with a voucher type program.

At the diabetes clinic, we discovered that there are patients that are struggling to cover the cost of their or their family’s diabetes medications. One example is a single mom who had one child with Type I diabetes, she was already having a hard time paying for her child’s insulin. Unfortunately, a second child also developed Type I diabetes and this was going to be an unfeasible financial burden for her. The clinic does have some samples, but not enough to cover her long-term. We worked with our outpatient pharmacy (it is nice to have your own outpatient pharmacy, but you could contractually do this with a contract pharmacy as well) to develop a voucher process that will allow for the clinic to have a set number of insulin vials per month on charity care, we are starting with 200 vials and we will assess the need for more or less as we move forward.

If you are considering this or wondering what the benefits of 340B can be, this is a good financial example, and the intent of the 340B program. When a hospital based clinic patient takes an outpatient prescription to our outpatient pharmacy, we purchase those medications at 340B pricing. This provides additional savings for our hospital. To extend and provide additional savings for this patient population, we can take patients who have financial need and give them the same medication on charity, and purchase the medication on 340B pricing. This allows us to stretch our charity care even further. You do need to think about the outpatient pharmacy and the cost to fill these prescriptions and 340B provides great savings, but there still is a cost for the drug.

This is our 340B Charity Care Voucher pilot. After we work out the process kinks, we plan on expanding this to our other hospital based clinics. If you have a similar program, please send it to us and we will post it as an article. We need to share our stories with each other and our legislature. If you have any specific questions, please send them on, we will answer them.

340B Program Notes from ASHP Midyear

ASHP Midyear Clinical Meeting was great!

Well, I made it back alive from the ASHP Midyear meeting. I am a tad bit under the weather from the trip, but I made it. I went to the all day Sunday 340B Federal Update, and confirmed and learned a lot. I am not sure I can adequately cover it all in a post, plus my notes are terrible. Here are some interesting take home messages:

Definition of a patient: Michele Herzog from OPA had this listed as a bullet item, but never gave a concise answer. I spoke with her after, and she said that it shouldn’t have been a bullet item (but it sure caught my attention). She did say that they are working on a more concise definition for a patient, and hopes to have one available by the end of December. No offense to Michele, she was great, but in government speak that means March-April.

Integrity concerns: We heard from a couple of guys from industry on double dipping and diversion concerns. Bottom line, they have legitimate concerns and we as covered entities need to make sure we are monitoring all of our processes that utilize 340B pricing to ensure we have complete integrity. This includes contract pharmacies. I actually sat down at a table with the Genentech guys. Decent group.

340B expansion: I am a fan of SNHPA and the work that Bill and Ted do for the 340b program, but I have to agree with Chris Hatwig (Apexus/340B PVP) that we need to be careful of pushing for further expansion. We are under so much scrutiny right now from the US Senate (I will not rehash the drug shortage claim), that trying to expand the program further will only jeopardize the whole program. Our SNHPA colleagues are still pushing for the inpatient discount, but I personally feel we need stop pushing for expansion and first prove we are using the cost savings/funds (contract pharmacy) for the intent of the program. We need to create stories of the hundreds, even thousands of examples of what we have done to increase or expand charity care services for our patients who have need of our help.

Key Association: I did not know much about the Apexus/340B Prime vendor group. I knew they were the pseudo GPO for 340B covered entities. I learned that they do much more. I was able to speak with Chris Hatwig and learn more about their efforts. My guess is all of you who are covered entities have signed up with Apexus, but if you haven’t, you really should. They negotiate sub 340B discounts and do a lot of work, much like SNHPA, on educating and outreach for the 340b program. I asked Chris why do all this other stuff, and he simply stated, because it needs to be done. Love it!

Is the 340B Program the Cause of Drug Shortages?

Are you serious???

I don’t usually get fired up about stuff that goes on in our legislature, but when you hear crazy statements that are clearly aimed at finding a loop hole in the 340b legislation, it makes me mad! Here’s the skinny:

A few weeks ago, President Obama made an executive order on drug shortages. One of the reasons for the shortage that was given by pharmaceutical manufacturers was the 340b program. There were some other more valid reasons including “low reimbursement for mature generic injectable drugs reduces the incentive to manufacture them.” This week, we found out that a Utah Senator, Orrin Hatch, (along with Senators Grassley and Upton) is drafting legislation that would halt 340b pricing for drugs that are in short supply for up to three years.

First, as a hospital pharmacy director (with responsibility for a retail pharmacy as well) the majority of drug shortages are for inpatient drugs. Most are critical care injectables and items we need to make TPNs. Since the 340b program primarily applies to outpatient drugs or drug administered to treat outpatients, I do not see how the 340b program has contributed to these inpatient drug shortages.

Second, for the outpatient drugs that are short, it is possible that the 340B program decreased profitability, which would cause manufacturers to stop making the drug. However, 340b purchases are still a very small percent of the market and this alone would not be enough to stop a manufacturer from making a drug. My system pharmacy contract manager made the point that the reimbursement structure is what contributes to this. GPO and IDNs have driven the price down so low (in an effort to keep costs down to consumers) that it is not profitable to continue making the product. If we could change the model to take into account expected manufacturing cost plus a margin to guarantee drug companies some profit in the generic market, we may see more stay in the market.

Third, and most scary. If you are a publicly owned pharmaceutical company and you need to increase profits. What is to stop you from artificially causing your drug product to go into shortage, which would place a hold on 340B pricing (and Medicaid rebates) for up to three years. Ultimately resulting in a nice profit increase for your shareholders, a bonus for you, and completely skirting around legislation created to help hospitals and clinics taking care of our citizens with the most need.

To summarize all of this, to create legislation to place a hold on the 340b program and Medicaid rebates based on the premise that it will help with drug shortages is off target at minimum and potentially disastrous for hospitals and clinics relying on 340b help to stay solvent. If this legislation goes through, I have no reason to believe that drug companies are going to do everything they can to prevent a shortage, rather they will potentially allow shortages to happen as the result will be more profit. Senator Hatch, don’t do it. If the statements above are not enough, then you have to know that this will be seen as a Big PhRMA pocket lining, that will be pointed out by any of your opponents (I am sure it will not escape the watchful eyes of the Tea Party).

340B Audits are Coming

HRSA has announced that 340B audits are coming

We all knew it was coming. First, the legislation was approved to fund OPA with a 0.1% user fee on all340B drug purchases. Then some of the GOP were calling for more oversight (eg, Grassley, Hatch, Upton). Well, here it is. In a letter from HRSA dated October 21st and made public on November 9th, it states that audits will begin February 6th, 2012. The letter also addresses various other 340B topics which are of value, but the audit stands out the most. It appears that the audits will be mostly around covered entities that have been reported as possible compliance or diversion risks.

The take home message: Know the rules and be conservative. As I have learned more about the program, I have quickly ascertained that many vendors and covered entities are operating in the gray zone. Now, this is likely due to the fact that there is a gray zone. The legislation is not specific and very little specific instruction has been given. In many cases, some language is give and then left up to interpretation. Our colleagues at SNHPA, PSSC, OPA are all doing their best to clarify, but in the end it often ends with “it’s an interpretation issue.” As a pharmacist (and even worse, a pharmacy director), this kills me. I see things very black and white, and struggle with gray. My hope, and I think we have reason to think it may happen, is that the extra funding for HRSA-OPA will result in clarification of these “interpretation” issues. That we will all have clear guidance on what is okay and what is not okay. Dare to Dream!!!

One other thing to think about. We are not perfect. As hard as you try, you might end up causing a double dip on Medicaid or using a 340B drug on a non-340b patient. Place some internal audits in place and do your best to identify these issues. When you find them, correct the error and then correct the process that caused the error. I would also say to share the information so we can all learn from it. I have a good one to share, but I will make it the next post. Best of luck in your 340B journey!

ASHP Midyear 2011 – 340B Program Update

Are you going to ASHP Midyear? Then you may want to attend the 340B Update

I was recently sent an invitation from Apexus (the Prime Vendor for the 340B program). On Saturday, December 4th from 8 am to 4 pm (I know, it is all day), there is a 340B program update. Here is a link to the flier. If you are like me, you are going for your hospital and have other assignments. As the pharmacy director, I need to be available for interviews at our PPS booth (we have pharmacy residents and we are recruiting for an ID pharmacist). I am planning on attending this educational 340B program, it is free, provides CE, and pre-registration is required (so it will not be packed tight at the last minute as can happen for hot topics during the other sessions). The flier above has the pre-registration link. Here are a list of the topics:

      HRSA’s key priorities to improve program integrity over the coming months
      OPA’s plans for implementing the new integrity provisions of the PPACA and recommendations made by the GAO in its final report
      The roles the PSSC and Prime Vendor Program are playing to support OPA integrity initiatives
      Hearing from representatives of covered entities and the pharmaceutical manufacturers regarding their perspective on new integrity provisions and compliance issues

I’ll see you there!

340B Program Blog Adds a New Team Member

Rich B and I are pleased to announce the addition of Rich I to our 340B Program Blog team

For starters, Rich I has been a coworker of ours for many years. He is a project manager with a finance background. When it comes to 340B program implementation in our health-system, Rich I is our go to expert. With our team’s different backgrounds and roles in 340B management, we feel that it is time to take this site to the next level. As we actively engage in contract pharmacy negotiations with vendors and retail chains with in house software, we will share what we learn with you. We are getting closer to contract approval on both sides and are excited to implement a voucher program to increase our charity care for our patients.

Rich I and I recently participated in a conference call with one potential contract pharmacy 340B vendor. We learned a lot about different ways vendors are approaching how they determine if a covered entity patient is eligible for a 340B drug at the contract retail pharmacy. Two very distinct ways are: 1) Purchasing prescription pads for your hospital and hospital based clinic use only, and have a unique identifier on the pads that lets the retail pharmacy know they are a 340B eligible script. 2) Have HL7 messages go from your health system to the vendor software to let it know which patients qualify. If the patient shows up at the pharmacy in a specified time from the hospital encounter with an eligible physician, then it would count as a 340B eligible prescription. There are good and bad with both, and we are considering these options. I am leaning toward, simple is sometimes better. We will let you know when we get off the fence and move forward.

340B Coalition Winter Conference 2012

The Winter 2012 340B Coalition Conference

Just in case you didn’t get the message, the Winter Conference for the 340B Coalition will be in San Diego at Del Coronado on February 29th to March 2nd. This is where I received my first major eduction on 340B and I strongly recommend it to all who are qualified to be a 340B covered entity and want to get a crash course on 340B. Not to mention Del Coronado in February is a great place to be. The Rich’s and I went last year and found some great places to eat. We are hoping to go, but I have this thing you may have heard of . . . The Joint Commission potentially coming in that time frame. They should be done by then , but who knows right. If you happen to work for The Joint Commission, please notice my proper use of your name and kindly drop me a line if I am okay to go. 🙂 The website to see the conference details is http://www.340bconferences.org/conferences/index.htm. If you are going, let us know and we can do a meet up at the Irish Pub we found with some great food, I had a Philly cheesesteak with au ju dipping sauce (I think I just made my mouth water). Hey Rich’s, we have to go back!!!