Notes from Joe
- Dateline: Washington DC
by Joe Pugliese, President and CEO
NHF Washington Days was live for the first time since 2020. Turnout was strong with over 400 people from the bleeding disorders community turning out to lobby our representatives to support the community, including some folks from team Alliance and several people from HTCs.
The first issue we tackled is HR 830, the HELP Copays Act, which was introduced Reps Carter (R-GA) and Barragan (D-CA). We were asking other representatives to co-sponsor this bill and for Senators to introduce a companion bill. The measure is designed to prohibit the use of copay accumulator adjustor programs. Why is this important? The annual out-of-pocket (OOP) maximum can be as high as $9,100 for an individual and $18,200 for a family. This means patients with chronic expensive conditions can look forward to paying ruinous copays every year, if insurers are allowed to pocket the copay assistance paid on behalf of a patient, and then turn around and demand the same amount from the patient.
I spent the day with the Florida contingent. We were well-received at all the offices we visited, but one visit really stood out. Two affected women in our group who are constituents of Representative Posey (R-FL) were describing the challenges they face in part because of copay accumulator adjustors. In the middle of the discussion, Rep. Posey looked to his staffer and announced that he was going to cosponsor HR 830. Heather and Samantha immediately broke out in tears. I would say it was contagious. The difference between being well received and getting a firm commitment to sponsor the bill is huge, and shows how effective these advocates were!
We also asked to maintain the current funding levels for the federal hemophilia programs at the CDC and HRSA, and to ensure that HTC participation in 340B is maintained (more on this shortly). Finally we asked for ongoing NHLBI funding. While we were in town President Biden proposed a $6.8 trillion budget, which makes the millions we’re seeking for our programs less than a drop in the bucket.
Other breaking news while we were in town was the joint announcement made by PhRMA and NACHC (the National Association of Community Health Centers) saying they have formed a new organization, the Alliance to Save America’s 340B Program—ASAP 340B. The new group released a set of principles about how they intend to save the program. We have been asked by any number of organizations what we think of this development. First, let me say we are of course very much in favor of saving 340B. The at-risk population we serve absolutely depends on HTCs having access to 340B as noted above. However, we are extremely concerned about what we’ve heard so far and believe that there could be several harms to the bleeding disorders community.
I do have a couple of questions. Why was all of this done in secret, without the involvement of other grantees like HTCs? Why are organizations with a long history of opposing 340B part ASAP 340B? Why did PhRMA not reach out to HTCs for input? It seems counterintuitive at best.
As we learn more about this group it is clear they either don’t know or do not care about the negative impact their proposals would have on our community. You will be hearing much more about this over the coming weeks and how you can help educate policymakers about how they can really protect 340B, HTCs, and they patients you serve. But the first “to-do:” please plan on coming to Washington, DC for the Alliance Hill Day this June to make sure our voices are heard. See below for more info.
- Product Update
by Joe Pugliese, President and CEO
Aminocaproic acid / Brand Name Amicar
On March 3, 2023, it was announced that Illinois-based generics firm Akorn had filed for Chapter 7 bankruptcy in Delaware, which affects us since they are the main maker of Amicar. We immediately reached out to the trustee assigned to manage the Akorn chapter 7 filing, the Office of Pharmacy Affairs, Mikart the contract manufacturers, and our now good friends at STAQ Pharma who brought DDAVP NS to market. (More on that below)
We did not hear from the trustee nor Mikart. The Office of Pharmacy Affairs was very responsive, but this issue is outside of their preview. STAQ Pharma started looking into the feasibility of producing first the aminocaproic acid liquid then the tablets. Since STAQ is a 503B outsourcing facility, the product needs to be listed on the FDA drug shortage list to manufacturer the product. Len Valentino reached out to the FDA asking to have aminocaproic acid added to the drug shortage list. He made a similar request of FDA for Stimate.
The FDA has been in close communication with the other manufacturers of aminocaproic acid and has received assurances that they will be able to supply the marketplace. If you experience difficulties sourcing the product, please let me know immediately. I can tell you that The Alliance Pharmacy has shipped all the inventory they had available.
I shared this information with Miriam Goldstein, the Vice President of Public Affairs at the Hemophilia Federation of America, and she was very helpful in providing some additional contacts. I wrote to the accounting firm overseeing the bankruptcy filing with an offer to purchase all the remaining inventory of Amicar. We will of course let you know if anything comes of this request.
As a reminder, DDAVP nasal spray is readily available from STAQ Pharma and you must purchase direct from STAQ if you plan on dispensing yourself. Where physician dispense is allowed you do not need to have a pharmacy license, they ship directly to the clinic using an NPI number.
Reimbursement remains challenging although we have some successes. Optum has been very helpful in making sure patients have access to product; I wish I could say the same for CVS Caremark and Express Scripts. We have spoken to the FDA on several occasions about getting regular approval for the product, which would definitely help address the reimbursement challenges. Our efforts to date have not yielded any results. We have had individual Medicaid plans reimburse, but without FDA approval Medicare is yet to provide reimbursement.
As a reminder, Dr. Amy Shapiro has provided us with a letter of medical necessity. It highlights the safety and efficacy of the product.
It you have questions about ordering or our DDAVP challenge program, please email me at firstname.lastname@example.org.
Many thanks to Len, Miriam, Amy and a host of others for your efforts to helping address these supply issues.
Register for the Hemophilia Alliance Hill Day this June!
by Johanna Gray, Advocacy Consultant
We’re headed back to the Hill IN PERSON! Please join us for the 2023 Hemophilia Alliance Hill Day, June 12th & 13th in Washington, D.C. All Alliance members and their patients are invited to join us to advocate for the bleeding disorders community. As Joe noted above in Notes from Joe, there is a LOT happening in DC related to HTCs, 340B, and the access to care issues that are important to Alliance members. If you’ve ever been on the fence about coming to DC, we really need you this year! See below for more details.
When: Monday, June 12th & Tuesday, June 13th 2023 (Training on the evening of 6/12, Hill meetings on 6/13)
Why: Since there are so many new Members of Congress and staffers, we will be educating Senators and Representatives and their staff members about bleeding disorders, HTCs, and the importance of the 340B Program to our community. We need your help to ensure policymakers understand our issues and continue to support the comprehensive care model for patients with bleeding and clotting disorders for years to come.
Who: We hope that many Alliance members will participate. We encourage you to also recruit a patient* from your center to join you.
Next Steps: Please click here to register to participate. The deadline for registration is MAY 12, 2023.
Any questions? Please contact Johanna Gray at email@example.com or 703-304-8111.
*Patients airfare, accommodations and ground transportation in DC will be paid by the Hemophilia Alliance.
Alliance Board Update
Alliance Seeking Board Nominations
by Becky Burns, Vice Chair, Hemophilia Alliance Board
The Hemophilia Alliance Board Nominating Committee is seeking applicants or suggested nominations to fill vacancies on the board of directors. For consideration by the nominating committee, applicants are to submit a letter of interest and resume or CV to firstname.lastname@example.org by Friday, April 14, 2023. We seek to broadly represent our membership and are encouraging applicants from all regions and disciplines to apply.
Applicants or suggested nominees must be employed by a Hemophilia Treatment Center in good standing with the Hemophilia Alliance, support the Hemophilia Alliance mission, vision and programs, and be willing to share their knowledge and expertise with the Hemophilia Alliance, participating in bi-monthly board meetings.
Terms are for a 3-year period, not to exceed 2 consecutive terms. In a typical year, the Board meets six times per year, three via conference call and three in-person. Two of the in-person meetings occur at the Hemophilia Alliance membership meetings and one board retreat takes place in January.
The Hemophilia Alliance works to ensure member Hemophilia Treatment Centers have the expertise, resources and public support to sustain their integrated clinical and pharmacy services for individuals with bleeding and clotting disorders.
Through the work of the Hemophilia Alliance, the clinical and pharmacy programs of the Hemophilia Treatment Centers are integrated, stable and sustainable within a changing healthcare environment. They are trusted and respected as the preferred way to provide people with hemophilia and other bleeding disorders access to the full range of care they need.
For more information about the Hemophilia Alliance visit our website hemoalliance.org.
What does it cost to be on the board?
There is no cost to be on the board.
When does the board meet?
Two in person meetings occur at the Hemophilia Alliance membership meetings, one board retreat takes place in January and three conference calls take place on the fourth Thursday of the month at 2pm EST.
What are the qualifications or degrees needed to be on the board?
You must be employed by the HTC and in good standing with the Hemophilia Alliance with previous committee or board experience. No other qualifications or degrees are needed.
Do I need to hold a particular role in the HTC?
Does my program have to be a large program to be on the board?
Candidates from all types of centers from new startup centers to well established programs are encouraged to apply.
What are some of the things I should include in my letter of interest?
- Your role with the factor distribution program.
- Things that interest you in serving on the Hemophilia Alliance board and what you feel you will bring as a member of the board.
- Include your experience with local, regional, national committees or boards related to hemophilia and related bleeding and clotting disorders.
If you have any additional questions please feel free to contact Becky Burns at email@example.com.
The Alliance Upcoming Events Webpage – A New Look & Feel
by Kiet Huynh, Manager of IT Solutions
Do you remember the last time you visited our Events page – https://hemoalliance.org/events? We have recently given it a makeover and it’s now ready for its debut. We have combined the event information for our members and non-members onto a single page for easy viewing and given each section its own color. The red outlined boxes (🟥) are Alliance member-only events which require a login to view and/or register for meetings and the blue outlined boxes (🟦) are non-member events. Visitors can choose between the default listing view or monthly view for all the events. Additionally, the events calendar can be downloaded and imported into your current email program. As always, please do not hesitate to reach out if you have any questions.
HANS PPO Agreement 42 signed, 65 To Go
by Jeff Blake, Senior Vice President Member & Community Relations
We continue to promote HANS and our PPO Agreement to our member HTCs and the payer community. In addition, we’ve had several discussions with payers to let them know HANS is a solution for Gene Therapy to direct care and services to HTCs. We now have 42 signed PPO agreements with our HTC members, and we are working with several other member HTCs to increase the number of signed PPO agreements. Imagine if all our member HTCs signed the agreement – we could offer the very best national network of HTCs to payers.
We now have 6 HANS Agreements with Payers that our members that have signed our HANS PPO agreement can participate in. The agreements are with:
||Security Health Plan
These agreements and individual letters of agreements (LOAs) have brought back millions of units to the participating HTCs pharmacy programs which as strengthened the sustainability of the programs. In addition, we continue to work with insurance brokers/consultants, insurance companies, third party administrators (TPAs), self-insured employers, stop-loss/reinsurance carriers, and other payers. Based on these payer relationships, we now have more the 50 active payer opportunities to bring back more business to our member HTCs.
We have accomplished a lot, but there is so much more that we can do. Below is a summary of the results of bringing business back to HTC pharmacy programs since 2018.
|Total new units 1/1/2018 – 12/31/2022
|Current opportunities/potential new units
The Hemophilia Alliance Team is excited about our efforts with payers to support our members and we look forward to working with more member HTCs to expand our HANS efforts to help you grow your pharmacy business to support your HTCs operations and programs.
If you have not signed a HANS PPO Agreement, now is the perfect time. Please contact a member of the Hemophilia Alliance Team to learn more about HANS or how we can assist in solving your payer issues.
Notes from the Community
- Update on Partners Physician Academy
We are excited to announce that the Partners in Bleeding Disorders Education Program is launching its second annual training program in classical hematology for early career physicians.
The Partners Physician Academy is a US-based, bleeding disorders-focused educational program delivered by hematology experts. The program’s goal is to provide fellows and early-career physicians with supplemental hemostasis-focused education while fostering connections that support their career development and future leadership as part of the HTC network.
With the generous support of the Hemophilia Alliance and The Alliance Pharmacy, this 5-day training course will take place September 17-22, 2023, in Indianapolis, Indiana. It is open to both pediatric and adult medicine physicians.
To see photos and testimonials from the 2022 Physician Academy, explore here: https://partnersphysicianacademy.com/academy-experience/
Applications are open, and must be received by April 7th, 2023, for consideration.
Inquiries regarding the Partners Physician Academy should be emailed to: PartnersPhysicianAcademy@ihtc.org
- Collaboration Updates with our National Organization Partners
by Karen Bowe-Hause, Director Member & Community Relations
Coalition Hemophilia B 2023 Symposium
March 16-18th Orlando Florida
Renaissance Orlando at Sea World
Hemophilia Alliance is a proud sponsor of live MASAC Meetings
March 24th -25th 2023
National Harbor, Maryland
Hemophilia Federation of America – 2023 Annual Symposium
For the 2nd year in a row, the Hemophilia Alliance and HTCs will be represented at HFAs Annual Symposium:
Renaissance Orlando at SeaWorld, Orlando, Florida
Friday April 14: 3:00 – 4:00 pm
Joe Pugliese, President and CEO of the Hemophilia Alliance will present an update on DDAVP NS availability.
Title: DDAVP NS (desmopressin acetate nasal spray) Availability Updates
Session Description: DDAVP has been a valuable treatment option for the bleeding disorders community. Commonly used to treat von Willebrand disease (VWD) type 1, and mild or moderate hemophilia A, the nasal spray version of desmopressin, (DDAVP) manufactured by Ferring Pharmaceuticals, issued a voluntary recall in the summer of 2020. The Hemophilia Alliance will be presenting the history of the recall and steps they have taken with STAQ Pharma, Inc. to ensure continued access to this important treatment option through DDAVP NS.
Saturday April 15: 10:45 – 11:45 am
We are honored to have Marilyn J. Manco-Johnson, MD, Professor of Pediatrics, from the Hemophilia and Thrombosis Center, University of Colorado, Aurora, CO representing the member HTCs of the Hemophilia Alliance. She will be presenting on the following topic:
Title: Evolving treatment options for Mild Patients: Engaging your HTC as a vital resource
Session Description: Join Dr. Marilyn Manco-Johnson as she shares a brief history of the U.S. HTC Network and its importance in advancing care and treatment options specifically for patients with mild bleeding disorders. Her perspective and expertise on treatment for mild disorders comes from decades of experience caring for bleeding disorders patients with a focus on innovating to improve the lives of her patients.
Dr Manco-Johnson’s session will feature 45 minutes of didactic information and 15 minutes of Q & A. Shellye Horowitz, HFA’s Director of Education, will be the staff host for this session. Shellye has spearheaded HFA’s efforts to recognize and support those with a mild diagnosis or those seeking a mild diagnosis through innovative educational programming and partnerships with key allies, like the Hemophilia Alliance!
Team Alliance Contact Information
We work for you! Please don’t hesitate to contact any of us with any questions or concerns: