Notes from Joe
How Did We Get Here and Where Are We Going?
By Joe Pugliese
As noted here and everywhere else over the last several years, we have been blessed with an explosion on new, innovative therapies over the last 5 years. There are many more coming, including gene therapy, alternate rebalancing therapies and improved extended half-life products delivered subcutaneously. All of these advancements have been made possible through the existence of the comprehensive care network created by an act of Congress, at the request of the patient community. The pharmaceutical industry’s substantial investment in this area would not have been possible without the network of HTCs to aggregate patients.
After decades in the making, gene therapy is almost here. Unlike the almost here of 25 years ago or 5 years ago, almost here means before the year is over. Dr. Steve Pipe recently gave a webinar on gene therapy and the presentation is posted online; if you missed it I would encourage you to listen to it in its entirety. What struck me the most during the presentation was how far we have come and how much more is possible, with the focus on continuous improvement of both current therapies and therapies that suddenly are right around the corner.
Ironically, in this issue is an update on a program developed by the University of Michigan, with a grant from the Hemophilia Alliance Foundation, focused on teaching children with hemophilia how to self-infuse. Predictably it is the dedicated staff at a federally funded HTC giving their own time to not just teach these guys how to infuse but taking the extra time to make it fun. You will note the esteemed Dr Pipe in the photo – lower left on his hands and knees at the bottom of the pyramid.
It is clear to me that the only appropriate place for gene therapy is in the hemophilia treatment centers. The promise of this treatment and all of those to follow will only be realized if we stay focused on how we got here and where we would like to go.
Notes about Upcoming Alliance Meetings
By Sean Singh
The More the Merrier: HTCs and Patients Wanted For Hill Day
We are in the final stages of planning for the 2020 Hemophilia Alliance Hill Day. This process takes a lot of coordination to schedule all the meetings with Members of Congress and we are hoping to finalize the list of participants in the next week or so. So, we are writing with two final requests for all Alliance members:
- Please attend the March Member Meeting and Hill Day! Thank you to the many Alliance members who have already registered to participate and we want to do a final call for any other centers to register. We do everything we can to make the event interesting, impactful and fun and we would be happy to answer any questions or help you overcome any barriers to your participation.
- Please invite a patient to join us in telling our story on Capitol Hill. We are able to accommodate additional patients and as a reminder, the Hemophilia Alliance will cover his/her transportation, hotel and meals costs. If you have a patient who is willing to come to DC and talk about all of the good work you do at the HTC with support from the 340B program, please let us know at your earliest. If you have any questions about sending a patient please contact Theresa Parker at Theresa@hemoalliance.org or 727-688-2568.
Here are more details about the Spring Member Meeting and Hill Day:
We have a Draft Agenda for the Spring Members Meeting, which will be held in Washington DC on March 29th to 31st, 2020. The general meeting will begin on Sunday March 29th at 2 pm followed by a networking reception at 5:30 pm. Please register here and book your hotel stay. Should you have questions about the meeting agenda, space, accommodations or any other logistics please contact us anytime.
May Meeting for NEW HTC Staff
We are pleased to announce we will be offering a meeting in May for NEW HTC staff or staff members that have not been to a Hemophilia Alliance meeting before. We are excited to be offering this additional meeting to our members. We know you have been asking about a meeting like this to be available. This meeting is being financially supported by our manufacturing partners.
Here are some Frequently Asked Questions:
Will the Hemophilia Alliance pay for transportation?
Yes, the Hemophilia Alliance will pay for transportation (airfare, train) to and from the meeting.
Who should attend?
Somebody who has never been to an Alliance meeting. It could be a doctor, nurse, physical therapist, social worker, pharmacist, administrative staff involved in running the HTC.
Will the Hemophilia Alliance pay for the hotel?
Yes, we will pay for two nights of hotel.
Will the Hemophilia Alliance provide for meals?
Yes, we will provide meals during the meeting.
When is the meeting?
May 6th to 8th, 2020. It will begin at 6 pm on Wednesday, May 6th and end at 12 noon on Friday, May 8th.
Where is the meeting?
How many people can my center send?
Each center should submit a list of three NEW people they would like to attend in preference order. We will select the first person on the list and as more space opens, we will go through the list as submitted. The deadline for submitting names is March 12th. We will offer a spot to one person from each site until we fill all the available spots.
How do I register for the meeting?
You can register here.
When is the deadline to register?
March 12th, 2020
What is on the Agenda?
Click here to see the Agenda.
Are there any other plans?
There are a limited number of spots available for a tour on Friday May 8th at 1:30 pm and presentation at University of Minnesota Health Fairview, Center for Bleeding and Clotting Disorders on Friday, May 8th at 1:30 pm. We will transport you from the Hotel to the University of Minnesota. You will be able to select to attend the tour when you register for the meeting.
May 6th to 8th 2020
Begins at 6pm on Wednesday.
Ends at 12 pm on Friday.
Additional tour to Fairview Center for Bleeding and Clotting Disorders to begin at 1:30 pm and end at 3 pm.
Join us for an Informative Meeting at HTRS/THSNA in April
By Sean Singh
The Hemophilia Alliance will be holding a Pre-Conference session at HTRS/THSNA on Wednesday April 22nd, 2020. Lunch will be served at the meeting which begins at 1 pm. The meeting will be led by Joseph Pugliese President and CEO of the Hemophilia Alliance. The topic of the session is “Sustainability of the HTC Pharmacy (340B) with Emerging Therapies.” This will be an interactive session where we discuss financial models for emerging therapies. The current and pending changes make maintaining your current business and expanding your footprint critical for sustaining the comprehensive care mode. The Hemophilia Alliance continues to work with Insurance Companies, Brokers and Consultants to keep HTCs in network and continue to give them access to provide pharmacy services in dispensing factor products to their patients. Please RSVP to Theresa Parker at Theresa@hemoalliance.org. Please feel free to contact us at any time with questions about the program.
2020 Meeting Schedule
- Social Worker Conference: February 26th to 28th
- Spring Members Meeting: March 29th and 30th in Washington, DC
- Hill Day visits: March 31st in Washington, DC
- HTRS/THSNA Preconference: April 22nd
- Meeting for New HTC Members: May 6th to 8th in Minneapolis
- Fall Members Meeting: October 4th to 6th
Governmental Food Fight: GAO and CMS Sling 340B Related Publications Back-and-Forth
By Elizabeth Karan
For policy wonks watching the 340B Program, 2020 began with an exciting series of reports released from the federal government. Although often long and boring, publications like these can alter policy and provide insight into future changes.
First, on January 8, 2020, the Center for Medicaid and CHIP Services (CMCS), within the Centers for Medicare and Medicaid Services (CMS), released an informational bulletin identifying best practices for states for the prevention of duplicate discounts in Medicaid (the “Informational Bulletin”). Mostly, the Informational Bulletin reiterates things that we know which are established in law. The Informational Bulletin also describes seven best practices for avoiding duplicate discounts in Medicaid. Again, these best practices are not new and commonly used practices for the prevention of duplicate discounts in the 340B Program. Likely, the Informational Bulletin was a preemptive rebuttal to another government report discussed below.
On January 10, 2020, the Government Accountability Office (GAO) released a report targeting 340B hospitals, indicating that increased oversight is needed of 340B eligibility requirements for hospitals. (The GAO functions as a “congressional watchdog” and monitors how taxpayer dollars are spent.) The GAO stated that approximately 1700 hospitals participate in the 340B Program as nongovernmental hospitals, which qualify for the program, in part, by having contracts with state or local governments to provide health care services to specified low-income populations. The GAO’s review of 258 contracts from nongovernmental hospitals found that most contracts contained this requirement but few details, such as the amount or type of care to be provided. The GAO made six recommendations to increase oversight of contracts by Health Resources and Services Administration (HRSA), including: requiring submission and review of appropriate contract documentation; reviewing validity of contracts and terms; and increasing training and oversight of the requirement in Office of Pharmacy Affairs (OPA) audits. At the 340B Coalition Winter Conference earlier this month, Admiral Pedley of OPA announced that OPA would begin reviewing these contract terms more closely.
On January 27, 2020, GAO released a second report examining oversight of duplicate discounts in the 340B Program. GAO reviewed documentation on preventing duplicate discounts, including federal policies and those from all 50 states and Washington, D.C. GAO also interviewed officials from CMS, HRSA, and 16 covered entities from four states. GAO found that CMS conducted limited oversight of state Medicaid programs’ efforts to prevent duplicate discounts. Additionally, GAO stated that CMS does not have the information needed to effectively ensure that states exclude 340B drugs from Medicaid rebate requests. GAO indicated that HRSA: (1) does not review states’ policies and procedures for the use and identification of 340B drugs; and (2) had not issued guidance on, and did not audit for, duplicate discounts in Medicaid managed care. Additionally, GAO noted that, in Medicaid managed care, HRSA does not require covered entities to address duplicate discounts or work with manufacturers to repay them. As a result, GAO recommended that CMS ensure that state Medicaid programs have written policies and procedures that are designed to prevent duplicate discounts and forgone rebates. GAO also stated that HRSA should incorporate covered entities’ compliance with state policies into its audits, and require covered entities to work with manufacturers regarding repayment of identified duplicate discounts in Medicaid managed care.
Reports are not binding. However, as Admiral Pedley’s announcement at the 340B Conference makes clear, they can impact policy. We expect that this is not the end of 340B Program oversight activities by CMS, GAO, or OPA and encourage you to stay informed, even when it involves getting messy.
By Jeff Blake
It has been an exciting start to 2020 for the Payer Team and we are very excited and energized for the remainder of 2020.
We are in the process of finalizing our third Hemophilia Alliance Network Services (HANS) Payer Contract with a mid-sized Pharmacy Benefit Manager (PBM) that wants to have a bleeding disorders solution to offer their clients that include HTCs and their pharmacy programs. Currently, this PBM excludes HTC pharmacy programs from their network and now they understand the value of the integrated medical and pharmacy model of care that our member HTCs bring to payers.
We continue to increase the number of member HTCs that have signed the HANS PPO Participation Agreement. We now have more than twenty (20) signed agreements and we are working with several additional members to finalize agreements. We still have a lot of work to do. We need at least 80% of our members to participate to have a strong national network offering to payers. As more members agree to participate in the HANS PPO Network, we are more aggressively contacting payers to contract with HANS to solve HTC payer issues. If you haven’t heard from us or haven’t provided a status update to your Hemophilia Alliance team member, please respond so that we may continue our efforts to bring your HTC more pharmacy business.
We have expanded the number of payers we work with. Recently, Mark Plencner and Jeff Blake presented HANS and the HTC model of care to forty (40) benefits and pharmacy consultants from Lockton and Excelsior Solutions. Lockton and Excelsior Solutions are national consulting firms working with health plans, self-insured employers and Medicaid Agencies. Establishing this new relationship has already led to three potential opportunities for HTCs. We have also developed a new relationship with Rx Benefits, another pharmacy benefit consultant, and we recently received a potential opportunity that includes more than 20 of our member HTCs.
We continue to work with the payers that we have established strong relationships. We have over fifty (50) potential opportunities with for our member HTCs and we are pursuing additional opportunities with these payers.
We will keep you updated on our efforts and look forward to working with you on solving your payer issues to grow your pharmacy programs. If you have any questions or would like to discuss in more detail, please contact a member of the Hemophilia Alliance Team.
Notes from the Community
University of Michigan Launches Infusion U Program
By Diana Mathis
Self-infusion is a critical skill for patients with severe bleeding disorders and a necessary milestone in preparing for adulthood. The advent of non-factor therapies has allowed patients with Hemophilia to treat prophylactically at home without the need for venipuncture, however infusions are still necessary for treatment of bleeds and it is important that patients learn and maintain this skill.
Learning self-infusion is one of those things that is just more fun when you are doing it with friends. The Infusion U program developed by the University of Michigan Hemophilia Treatment Center team offers an opportunity to do just that.
The program has been designed as an interactive educational program which includes learning basic concepts of bleeding disorders and training in self-infusion techniques with the ultimate goal of transferring skills to the home environment. The program provides ample opportunity for nurses to work with patients identifying and addressing individual barriers to learning. Working in a group gave children a sense of belonging, increasing their motivation to learn. Repetitive sessions supported the development of skills and provided opportunity for practice and reinforcement.
Thanks to a grant from the Hemophilia Alliance Foundation, the program has been made available in a downloadable format that can be individualized by each treatment center. The program includes lesson plans, invitation templates, graduation certificates, registration templates, take home assignments and questionnaires.
Team Alliance Contact Information
We work for you! Please don’t hesitate to contact any of us with any questions or concerns: