Notes from Joe
“If not us, who? If not now, when?” – John F. Kennedy
by Joe Pugliese, President and CEO
Nothing like the real threat of World War III to take one’s mind off the pandemic. We wish everyone the security of a peaceful world, which certainly a big ask. You have to be amazed and in awe of the mettle the Ukrainian people have shown. Our tepid response to date has never been shown to work in the past. The Ukrainians are pretty sure it is not working, now. I would have to agree with them.
It has been difficult to watch pregnant women, children and the elderly be terrorized by a relentless indiscriminate shelling and their lives are lost or forever changed by the most recent lawless, cowardly actions of Vladmir Putin and company.
Like it has done in the past, the Alliance has been looking for ways to assist during this disaster. We have turned to the World Federation of Hemophilia USA. They have created the WFH Solidarity Fund. The Alliance Board has made an initial donation to ensure they have the resources on hand to respond to requests from the national member organizations (NMOs) in the Ukraine, Poland, Germany and beyond at the situation continues to evolve. We will be staying in close contact with them over the coming weeks, months and most likely years.
Meanwhile, we are also trying to stay focused on the needs of the bleeding disorders community here at home. Click here to see a great article about Hemophilia of Georgia, who has been a driving force in the hemophilia community here in the US and around the world for years. Turns out they are also a great place to work, certainly a plus in a job market that makes attracting and retaining employees critical to fulfilling your mission.
Finally, we are coming up on the one-year anniversary of the production of DDAVP NS. It is a great milestone of when the community came together to address an urgent need for mild-moderate hemophilia A and type 1 Von Willebrand patients. It also means that the next lot produced will have 12 month dating from the date of manufacture. There remains a supply of product that will expire on 6/28/2022. All of this product is available through the DDAVP NS Challenge Program. We would not want to see any product go to waste. If you have questions about the Program, email me at email@example.com.
I will leave you with another JFK quote it is printed in our passports:
“Let every nation know, whether it wishes us well or ill, that we shall pay any price, bear any burden, meet any hardship, support any friend, oppose any foe, in order to assure the survival and the success of liberty.”
340B Program Developments
by Elizabeth “Issie” Karan, Legal Counsel
On March 11, 2022, the U.S. District Court for the District of Delaware ruled that the Biden administration exceeded its legal authority when it used a letter to demand AstraZeneca honor discounts provided through the 340B program to contract pharmacies. The move marks a blow to the Biden administration, which had relied on letters to push drugmakers to resume providing discounts to 340B covered entities with contract pharmacies. The decision vacates the letter and remands to the HHS for further consideration and marks the latest development in an ongoing saga over the 340B program
AstraZeneca, along with more than a dozen other manufacturers, has been limiting shipments of discounted products to contract pharmacies. Hemophilia Treatment Centers (HTCs) have been able to circumvent many of these restrictions. However, please keep reading to learn more about concerning developments from Gilead.
HTCs may be impacted by forthcoming changes to Gilead’s contract pharmacy operations. In a letter dated March 15, 2022, Gilead announced a request that all 340B covered entities provide claims level data for prescriptions of Gilead’s branded hepatitis C products dispensed from contract pharmacies, as of May 2, 2022. This policy includes data for prescriptions of Epclusa® (sofosbuvir / velpatasvir), Harvoni® (ledipasvir/sofosbuvir), Sovaldi® (sofosbuvir) and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) (although the program does not apply to authorized generics of Epclusa® and Harvoni® offered by their subsidiary, Asegua Therapeutics).
In the letter, Gilead stated that covered entities that provide claims level data will be able to continue to use the contract pharmacies of their choice. If covered entities decide not to participate and do not have an in-house pharmacy, they will have the option to select a single contract pharmacy location. The letter further indicates that, after May 2, 2022, covered entities that elect not to participate will no longer be eligible for bill to / ship to orders of 340B-priced HCV drugs for contract pharmacies.
The Alliance is deeply concerned about this overreaching and unwarranted intrusion into the physician-patient relationship. HTCs should respond to targeted requests from manufacturers for 340B transaction information that relate directly to your compliance. However, inquiries should provide the recipient with details on the specific claims for which additional information is being requested and explain why these claims implicate compliance with the 340B statute’s prohibition on duplicate discounts and/or diversion.
The Alliance is reaching out to Gilead to request an exception to this policy for HTCs (see here for a letter we sent to Gilead on the issue) and will share an update as we have it. Please contact our team if you need assistance with this issue.
Recap of the Alliance Hill Day!
by Johanna Gray, Advocacy Consultant
I have to start the recap of our recent Alliance Hill Day with a huge THANK YOU to all of the participants. More than 80 people representing 29 HTCs and 22 states joined for meetings with Members of Congress and their staff members last week. And a special shout out to my colleagues who were all team leaders and cheerfully put up with meeting changes and about a million emails from me about the event.
In our meetings, we educated policymakers about a few main issues:
- We provided general education about bleeding disorders and HTCs.
- We discussed federal programs important to our community, including the 340B Drug Discount Program. We discussed how HTCs participate in the 340B Program and how program income that HTCs generate fund many important staff people and programs that benefit all of the patients seen at the center.
- We shared information about the “alternative funding model” program, a new insurance practice by self-funded plans that shifts costs and patients from having medications covered by the plan to being passed to manufacturer assistance free product programs. This is impeding access to care for our patients and will raise costs for all patients, payers and taxpayers if left unchecked.
We had a great reception on all of these items. We heard broad support for HTC participation in 340B and each year we have a greater understanding by the Members of Congress and staff about HTCs and the importance of federal programs – including 340B – to our centers and the patients they serve. We also got a great response about the alternative funding issue. As a newer issue, we got lots of questions, too, but most folks recognized that the practice was wrong. (Getting folks in DC to agree that there’s a problem is at least half of the battle in trying to solve it!). We’re digesting all of the meeting evaluation forms and follow up needs but are hopeful that we’ll be able to work with Congress on a policy solution to the alternative funding issue in the coming weeks.
Finally, I’ll close with my annual request that folks consider joining us next year. We really do try to do all of the heavy lifting so all you have to do is show up and share your story. I think participants will even agree that it was fun, despite being on zoom again this year (see some of the team photos here!). If you would like to get more involved in educating or advocacy with Congress, please let us know!
HANS Signs 6th Payer Contract!
We have exciting news! Hemophilia Alliance Network Services (HANS) signs its 6th Payer Contract with a regional insurance company, AultCare located in Ohio. We are working with AultCare on the implementation process and we will be in contact with HTCs that have signed our HANS PPO Participation Agreement in the AultCare service area. We continue to meet with various payers to increase the number of HANS payer contracts and we will provide updates on our progress.
Currently, we have 40 member HTCs that have signed HANS PPO Participation Agreements and we are working with several additional HTCs to finalize agreements. Our long-term goal is to create a National HTC PPO Network that we can market to any payer, regionally and nationally. If your HTC has not signed an Agreement, please contact a member of the Hemophilia Alliance Payer Team to learn more about HANS and our PPO Agreement. Remember, participation in this opportunity is free and the agreement itself provides significant flexibility to the member HTC.
We continue to have success with payers and bringing back pharmacy business to our member HTCs. Since 2018 we have worked to bring back over 40,000,000 units to HTC pharmacy programs and we are currently working on opportunities with payers and member HTCs on an additional 75,000,000 units. With the pressure on price points and significant competition from mail order entities, this volume is important to the future sustainability of any HTC.
We look forward to working with you to grow your pharmacy programs and have HANS become a National HTC PPO Network.
Alliance Seeking Board Nominations
by Eric Gray, CPA, Vice Chair, Hemophilia Alliance Board
The Hemophilia Alliance Board Nominating Committee is seeking applicants or suggested nominations to fill two vacancies on the board of directors, with the term beginning June 2022. For consideration by the nominating committee, applicants are to submit a letter of interest and resume or CV to firstname.lastname@example.org by end of day Friday, April 29, 2022. 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 non-pandemic 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. Due to the Covid-19 pandemic, the Hemophilia Alliance Board and Leadership will continually assess the appropriate setting for all meetings. During 2021, one meeting was held in person and also provided a virtual attendance option.
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 an employee of the HTC and in good standing with the Hemophilia Alliance. 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 me at email@example.com.
Recap of the Linda Gammage Social Work Conference
by David Rushlow, Chair
The 24th annual Linda Gammage Social Work Conference was held in Nashville in late February. The conference was attended by 35 social workers who work in HTCs across the United States. For the first time we were able to offer a virtual option for those who were not able to join us in person.
We kicked off the meeting with a networking reception the night before the conference began. Everyone was so excited to be together, as we hadn’t been able to safely plan this meeting and be in-person since the start of the global COVID-19 pandemic. It was great to catch up with our colleagues, share ideas and network, and set the tone for the next two days.
Renee Jennings, MA, LCSW presented for a day and a half on “Transforming Trauma Through Somatic and Energy-Based Interventions: An Integrative Approach.” Renee is a therapist in private practice in Philadelphia, PA.
Her presentation focused on healing from psychological trauma using somatic and energy-based interventions. She incorporated several group exercises to allow for experiential learning which enabled us to practice skills and experience the interventions first-hand. Renee’s amazing warmth and teaching style captured all of us from her first words spoken and had us enthralled for the entire meeting. We gained a new awareness of trauma interventions and learned effective energy-based techniques to use with our patients.
A huge thanks to Mark Guidarelli and Thomas Jones from CSL Behring who continue to support the social workers with a grant provided to the Alliance that allows us to hold the conference. We are also grateful to Joe Pugliese and Sean Singh from the Hemophilia Alliance who continue to support our conference from year to year. Kiet Huynh gets a shout out for his technology prowess and coordinating the virtual component. Jeff Amond is the Alliance Representative on the committee and made our work so easy! He is our go to for everything and a “jack of all trades.” His great sense of humor never gets old.
Thanks also to the hard work of the planning committee who meets throughout the year to plan this event: Colleen Joiner (my co-chair), Amy Wilson, Jennifer Borrillo, Eric Iglewski, and Kathaleen Schnur. We are already planning the 25th conference which will be held in April 2023, and hope to see many of the social workers there.
Notes from the Community
Hemophilia Alliance Foundation Awards 2022 Project/Patient Assistance Grants!
Thank you to all of the organizations that applied for a Hemophilia Alliance Foundation (HAF) Project/Patient Assistance Grant! This year, we are proud to announce that we awarded over $500,000 to 58 organizations in the inherited bleeding and thrombotic disorders community. Congratulations to all of our recipients!
These Project/Patient Assistance Grants will directly support essential patient-centered programs in the community, including educational and advocacy events, patient assistance programs, travel grants to national and local meetings, and much more. We are thrilled to see the creativity and collaboration in many of the grant applications.
If you missed this grant cycle, please remember to mark your calendars for early December, when the Project/Patient Assistance Grant applications are released annually. Applications are due at the end of January. For those who are interested in applying for HAF’s Innovation Grant (up to $50,000), applications will be available in April 2022. More information will be announced soon.
Want to be notified when the next HAF grant application cycle is open? Please click here to add your name and email address so that we can add you to the HAF listserv. If you would like to make sure that you, or someone else in your organization, is part of our listserv, then please make sure they complete this form!
Any feedback for us? We continue to try to improve our grant guidance and application form. We’d love to hear your feedback. Please fill out this anonymous survey by clicking here.
World Federation of Hemophilia: Global Reach. Local Impact.
– by Jennifer Laliberté – WFH USA National Director
Since 1963, we have worked to improve access to care for all people living with an inherited bleeding disorder, regardless of where they live. In collaboration with our national member organizations and healthcare providers in 147 countries, we support sustainable care by building capacity for diagnosis, treatment, and advocacy.
The WFH Guidelines for the Management of Hemophilia have been vital to achieving those objectives: cited over 1,000 times, the second edition remains our most widely accessed resource. The new edition published last August provides important updates and additions, including over 300 evidence-based recommendations to guide best practice. To further the promotion and implementation of these recommendations – and thanks to the support of the Hemophilia Alliance — we will also be releasing slides decks, narrated videos, and chapter snapshots to highlight key learnings. Keep on the lookout for these soon-to-be-released resources on the WFH website.
The World Bleeding Disorders Registry (WBDR) is another valuable tool to support clinical care and advocacy around the world. First launched in 2018, the registry now contains clinical data on over 7,400 people with hemophilia in 39 countries, and has provided communities in countries like Bangladesh and Kyrgyzstan with their first ever national registry. Upcoming plans include developing myWBDR, an app developed in collaboration with PROBE that will allow for easier collection of patient-reported outcomes.
2021 will see the launch of our ground-breaking Gene Therapy Registry (GTR). As we enter a new treatment era, this important initiative will help determine the long-term safety of gene therapies in people with hemophilia, with data collected either directly via the HTC or through linkages with existing national registries like ATHN. We look forward to sharing more information in the months ahead.
As members of our global community, you are an integral part of our vision of Treatment for All. We hope you will join us as we celebrate the strength and solidarity of our bleeding disorders family on World Hemophilia Day this April 17th. Encourage your community to join us on social media using the hashtags #WHD2021 and #WorldHemophiliaDay, or consider making a gift to support the WFH’s global mission at give.wfh.org/give-usa.
To learn more about our work and how you can get involved, contact us at firstname.lastname@example.org.
Team Alliance Contact Information
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