In this Issue…

Notes from Joe
· Looking Back on 2022

Alliance Board Update
· Welcome New Alliance Board Members!

Alliance Update
· Save the Date for Alliance Meetings for 2023!
· HTC Wall of Walkers 2022 Update
· Flashback to the Fall HTC Member Meeting in October

Legal Update
· Alliance Legal Activities Recap

Washington Update
· 2022 Wrap Up

Payer Update
· Recap of Payer Activity

Notes from the Community
· Hemophilia Alliance Foundation: Announcing Project and Patient Assistance Grants!

Team Alliance Contact Information

Looking Back on 2022
by Joe Pugliese, President and CEO

Writing this at the end of 2022, on one hand it seems like the COVID situation is over, but maybe not, regardless it is clear that people here and around the world have had it with their leaders trying to impose controls on their life. We are back to a full slate of meetings everyone is genuinely excited to meet in person. Personally, I mask up in airports, planes and trains. I have been vaxed, boosted and boosted plus. Naturally I also got covid, but the good kind, felt bad but not too bad, got better.

The Alliance had another good year thanks to the ongoing support of our members, the patient community and our manufacturing partners. We continue to expand the services and support we provide the community. As always, it is with an eye on maintaining and expanding the quality and access to care. We now have just over a year of providing DDAVP NS to the community. It is so rewarding to hear from patients who rely on this product to help them have a better quality of life. We continue to talk to the FDA about path forward to attain an ANDA (abbreviated new drug application). The goal is resolving the ongoing reimbursement challenges, which of course limit access to care. It would also make it possible to export the product to meet unmet needs around the world.

Earlier this year we had the opportunity to be the primary sponsor of the inaugural Partner’s Physician Academy. “The Academy sought to address the training gap existing for most physicians upon completion of a hematology-oncology fellowship. Physicians are simply not adequately prepared to embark on a career at an HTC. The Academy also aimed to provide participants with an unparalleled opportunity to network with some of the key opinion leaders in the HTC network.” Said Chris Roberson. Looking to 2023 and beyond the Hemophilia Alliance will be the exclusive primary sponsor and The Alliance Pharmacy will be the exclusive supporting sponsor of the Physician Academy per an MOU signed this month.

The Alliance Board also approved expanded financial support for the National Hemophilia Foundation. We presently fund Partners in Progress (PIP) which supported Advocacy, Community Education and Chapter Services (including this Chapter Leadership Summit). and the Red Tie Society (which is unrestricted membership money) is used to offset unfunded or partially funded programs that included Research, Walks, and Awareness designed to raise the visibility of bleeding disorders across the country and create a voice for the community within our partnership. We will also be providing funding to ensure there are in person MASAC meetings and money for health care providers to attend the annual Bleeding Disorders Conference.

The year of course started with the most brazen and sustained act of terrorism since World War II. The Ukrainians are being forced to live in constant fear of missile and drone attacks and without basic necessities like food, water and heat. The year is ending with the good citizens of Iran and China saying enough is enough. All I want for Christmas is for them to get the opportunity to live with the freedom and safety we take for granted and enjoy here.

Merry Christmas and Happy New Year!

“Let every nation know whether it wishes us well or evil 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 success of liberty.” – JFK

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Welcoming New Alliance Board Members!
by Joe Pugliese, President and CEO

Since its inception, the key to success for the Alliance has been the remarkable people who volunteer their time and expertise to support and guide our efforts. The Board has been constantly evolving over time. I have to admit in the early days, past the core group of true believers, convincing people to serve was at times a challenging endeavor. New Board candidates today apply for the position. The nominating committee made up of the Vice Chair and two at large Board members have the difficult job of selecting from multiple candidates and presenting their recommendation to the full Board.

We were again blessed with a large field of excellent candidates for the two open Board positions. I am pleased to introduce John Myers RPh, MBA as a returning Board member and Justin Nelson, Director of Operations at Children’s Minnesota, as our new Board members. You will note that Justin has spent some time on the commercial side of healthcare; we welcome his insights.

Finally, a big thank you to everyone who applied to serve on the Board. We will have two Board members retiring next year and we absolutely need and appreciate the support from all of our members with a special thanks to all of those willing to serve.

John Myers, RPh, MBA has over 35 years of pharmacy experience. He began working at Cincinnati Children’s Hospital Medical Center as a staff pharmacist and later transferred to the Division of Home Care Services. In 2007, he was promoted to Director of Home Care Pharmacy. Under his leadership, Home Care Services has received the PRC National Excellence in Healthcare award, Magnet recognitions, Joint Commission Infusion/Specialty Accreditations and URAC Specialty Pharmacy accreditation. In December 2020, he was promoted to the Director of Pharmacy Operations at Cincinnati Children’s Hospital Medical Center. In his new position, he has oversight of Home Care Infusion Pharmacy, Specialty Pharmacy and the Retail Community Pharmacies. In March 2022, the Specialty Pharmacy was recognized as a 2021 Pioneer in URAC’s Leaders in Performance Measurement (LPM), an award given to a new specialty pharmacy who is promoting trust in the quality of care delivered through performance measurement activities. In December 2022 the Specialty Pharmacy was once again awarded Full URAC Accreditation for Specialty Pharmacy.

John earned his Bachelor of Science degree from the University of Cincinnati, College of Pharmacy, and a Master of Business Administration degree from Xavier University. He served on the Board of Directors of the Hemophilia Alliance from 2014-2020. He also served on The Alliance Pharmacy (TAP) Board of Directors from 2022-2022.

Cincinnati Children’s Hospital Home Care Pharmacy provides a full range of infusion, enteral and specialty pharmacy services, for patients living in OH, KY, and IN. The Home Care Pharmacy is also the in-house pharmacy provider for Cincinnati Children’s Hemophilia Treatment Center (HTC). For more than 25 years, The Home Care Pharmacy has been dispensing bleeding disorder medications to HTC patients and working closely with HTC staff to provide coordinated care and consistency in service.

Justin Nelson is the current Director of Ambulatory at the Center for Bleeding and Clotting Disorders at Children’s Minnesota in Minneapolis. Returning to the center in 2021, Justin has 4 years’ experience in the bleeding disorders community as well as 340B operations. In addition to his experience in bleeding disorders and 340B, Justin has 15 years of business operations in healthcare with organizations such as MinuteClinic, Prime Therapeutics, Walgreens, HealthPartners and more. Additionally, Justin has published many short articles and post for TranspharmD.com on topics such as LGBTQ rights, mental health, racial disparities, healthcare inequalities.

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• Save the Date for Alliance Meetings for 2023!

by Theresa Parker, Administrator

Hemophilia Alliance has been working diligently to ensure a full schedule of meetings for the upcoming year. After the difficult years of 2020-2022, it is refreshing to get back to “business as normal” and continue the trend of in-person meetings. There is a lot of activity in the hemophilia community, and it’s been an interesting exercise to navigate around these events.

We are excited to announce several new meetings in 2023 to bring together professionals in the blood disorder field to discuss important issues and advancements. These meetings will provide an important platform for attendees to network, learn from industry experts and share their own experiences. We hope to see you at one or more of these exciting events.

Mark your calendars to SAVE THE DATE!

Hemophilia Alliance Meeting Schedule for 2023


January 26-28	Pharmacist CE Meeting	San Diego, CA
February 13-15	Spring Members Meeting	Nashville, TN
April 26-29	Social Worker CE Conference	San Mateo, CA
May 10-12 (tentative)	New HTC Staff Meeting	TBD
June 12-13	Hill Day	Washington, DC
September 19-21	Fall Members Meeting	TBD

In addition to the above meetings, we are working on other meetings that you have requested. Stay tuned. More to come!

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• HTC Wall of Walkers 2022 Update

by Karen Bowe-Hause, Director Community Relations

In collaboration with the National Hemophilia Foundation, the Hemophilia Alliance was proud to sponsor the 2nd annual Unite Walk Wall of Walkers campaign, designed with the intent to inspire further partnerships between our member Hemophilia Treatment Centers & their local Chapter affiliates. The Alliance would like to congratulate the 2022 Wall of Walkers Top 5 Hemophilia Treatment Center teams who have earned top fundraising status for the Unite for Bleeding Disorders Walk in their assigned market! Collectively, the 36 member HTC teams organized raised more than $35,000 to support their local Chapters through this initiative in 2022. Each of the 5 top HTC teams will receive a $1,000 scholarship that is intended to be used to send a staff member to the 2023 Bleeding Disorders Conference that will be held August 17th-20th in Washington, DC.

The 5 winning teams are:

Ortho Walkers (Team Captain – Doris Quon) – Orthopaedic Institute for Children Hemophilia Program, in support of the Hemophilia Foundation of Southern California
HTC – Smells like HEME Spirit (Team Captain – Zack Duffy) – Oregon Health and Science University Hemophilia Center, in support of the Pacific Northwest Bleeding Disorder Foundation
Indiana Hemophilia and Thrombosis Center (Team Captain – Tyler Hufnagle) – Indiana Hemophilia and Thrombosis Center, in support of Hemophilia of Indiana
Team Hemophilia Treatment Center (Team Captain – Lisa Littner) – Cincinnati Children’s Hospital, in support of Tri-State Bleeding Disorder Foundation
Rady Children’s HTC (Team Captain – Courtney Thornburg) – Rady Children’s Hospital, in support of Hemophilia Association of San Diego County

The Hemophilia Alliance would like to thank ALL of our member HTC teams for supporting the community, the local Chapters and NHF in one of the largest fundraising events for NHF and Chapters across the country!!


EVENT NAME (HTC CITY/STATE)	TEAM NAME	TEAM CAPTAIN
2022 UNITE WALK (Los Angeles, CA)	Ortho Walkers	Doris Quon
2022 UNITE WALK (Portland, OR)	HTC – Smells Like HEME Spirit	Zack Duffy
2022 UNITE WALK (Indianapolis, IN)	Indiana Hemophilia & Thrombosis Ctr	Tyler Hufnagle
2022 UNITE WALK (Cincinnati, OH)	Team Hemophilia Treatment Center	Lisa Littner
2022 UNITE WALK (San Diego, CA)	Rady Children’s HTC	Courtney Thornburg
2022 UNITE WALK (Denver, CO)	Chill Factor	Kimberly Hurdstrom
2022 UNITE WALK (Anchorage, AK)	HTC 2022	Kyme Groller
2022 UNITE WALK (St. Louis)	The Coagulators – Wash U/SLCH	Makenzie Sledd
2022 UNITE WALK (Boston, MA)	CT Children’s	Julia Gardner
2022 UNITE WALK (Illinois)	Rush HTC Mad Infusers	Mindy Simpson
2022 UNITE WALK (Fargo, ND)	Sanford’s Stop the Bleed Team	Kim Rasmussen
2022 UNITE WALK (Cleveland/Akron, OH)	Akron Children’s Hospital HTC	Irene Boehlefeld
2022 UNITE WALK (Houston, TX)	Texas Children’s Hospital HTC	Trinh Nguyen
2022 UNITE WALK (Cleveland/Akron, OH)	UH Rainbow HTC	Susan Hunter
2022 UNITE WALK (Los Angeles, CA)	CIBD: Time to Get Moving	Grace Hernandez
2022 UNITE WALK (Grand Rapids, MI)	Helen DeVos Children’s Coag Team	Deanna Mitchell
2022 UNITE WALK (Pittsburgh, PA)	Bubble Brigade	Kathaleen Schnur
2022 UNITE WALK (Hiawatha, IA)	Iowa Treaters	Karla Watkinson
2022 UNITE WALK (Milwaukee, WI)	CCBD	Tiffini Mueller
2022 UNITE WALK (Honolulu, HI)	Blood Sweat and Love	Johnelle Kane
2022 UNITE WALK (Dallas, TX)	Children’s Health Hemophilia Allstars	Michele Salinas
2022 UNITE WALK (Westerville, OH)	NCH HEME TEAM	Linda Casto
2022 UNITE WALK (Montana/Wyoming)	Chill Factor	Angela Blue
2022 UNITE WALK (Westerville, OH)	Team OSU	Abigail Rabatin
2022 UNITE WALK (Pittsburgh, PA)	HCWP/CHP	Frederico Xavier
2022 UNITE WALK (Las Vegas, NV)	HTCNV/SCCNV	Lawrence Avancena
2022 UNITE WALK (Anchorage, AK)	ABDC Adminions	Dave Groller
2022 UNITE WALK (Kansas/Missouri)	KC HTC	Debbie Nelson
2022 UNITE WALK (Reno, NV)	HTC Reno	Sonya Davis
2022 UNITE WALK (Houston, TX)	Gulf States Hemophilia & Thrombophilia	Sabrina Farina
2022 UNITE WALK (Omaha, NE)	Children’s Hospital & Medical Center	Amanda Whitman
2022 UNITE WALK (Charleston, WV)	CAMC HTC	Donna Arden
2022 UNITE WALK (Williamsburg, VA)	CHKD HTC	Megan Songer
2022 UNITE WALK (Boston, MA)	BOSTON STRONG!	Clifford Haas
2022 UNITE WALK (Houston, TX)	Team Frank	Lindsay ONeill-Dewing
2022 UNITE WALK (Milwaukee, WI)	Hemophilia Outreach Center	Erica Brock

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• Flashback to the Fall HTC Member Meeting in October

by Jennifer Anders, Manager of Data and Analytics

We had a wonderful turnout of 105 members in beautiful Salt Lake City, Utah. The Alliance values each of our members and their experiences at all our meetings and we were fortunate to receive feedback from 52 of our attendees.

We welcomed both new and old faces with 22% of the attendees experiencing their first Hemophilia Alliance meeting.

All the speakers did a wonderful job of presenting on various topics, such as the Faces of Data and the Mental Health talk, but there were a few talks that the respondents found the most useful (top 5 listed below). Gene Therapy was a hot topic at this meeting, with about 5 separate talks. We received several comments on working to consolidate the Gene Therapy topic in the future.

It was great hearing that our members enjoy these meeting and getting to network, but we also appreciate the constructive feedback we receive that helps us serve all of you better in the future. While COVID did impact attendees both prior to and after the meeting, we will continue to take the meeting spaces and any necessary precautions into account. Additionally, always feel free when registering for these meeting to provide us with any special dietary needs or restrictions. Thank you to those who took the time to respond to our survey and as we look forward to another great year in 2023, always feel free to reach out with any suggestions or feedback and we will do our best to act.

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Alliance Legal Activities Recap
by Issie Karan, Legal Counsel

Happy New Year to everyone! Here’s a quick recap of what we’ve been up to this year:

340B Lawsuits and Other Developments
The legal team devoted significant time this year staying abreast of developments in ongoing litigation related to the 340B program. By some estimates, as many as 37 lawsuits are pending related to the 340B program, with approximately half relating to restrictions on the use of contract pharmacies by at least 17 manufacturers. Most notably for HTCs, which have largely been able to avoid contract pharmacy limitations from manufacturers, a ruling was released this summer in Genesis Healthcare Inc. v. Becerra. This case stems from a dispute over removal of Genesis from the 340B Program by HRSA following an on-site audit conducted in June 2017 and challenges the validity of the longstanding definition of “patient” under the 340B program. We will continue to monitor and update members accordingly as these cases proceed.

Gene Therapy Preparation
This year, the legal team worked extensively with multiple parts of the Hemophilia Alliance team to assist HTCs in preparation for gene therapy products coming to market. Our work involved drafting model agreements for members to use in contracting and advising on other operational challenges. Recently, several HTCs have explored adding new “ship-to” locations to their OPA database listing to allow shipping of gene therapy products directly to co-owned pharmacies with capabilities for their storage and administration. While this approach may work for HTCs within larger systems, we also worked with members needing to make other plans for their patients to access novel therapies. We encourage members to keep reaching out to us with questions and to help with connecting similarly situated members exploring their options.

Conversations with Members Regarding Compliance
As always, the bulk of the legal team’s work with members involves fielding and assisting with questions regarding allowable expenditures of federal funds. More specifically, we help members understand and interpret the Uniform Grants Guidance and other funding requirements. Repeatedly, members have inquired about the application of salary caps on HTC programs as this limitation significantly impacts their ability to attract hematologists with competitive salaries. HTCs frequently inquire about how to support the work of patient chapters in their communities. Additionally, members have asked for advice on allocation of staff time, use of program income to pay for memberships in professional societies for staff, and appropriate indirect cost rates.

We also assisted members which were crafting policies for supporting patients. These programs often want to provide patients with help getting to appointments, paying for therapies, and to address other barriers to care. However, patient assistance programs implicate federal laws related to fraud and abuse. The legal team tries to help members understand these restrictions.

Finally, members reach out to the legal team regularly with questions on 340B program compliance. This year, questions ranged from site registration issues to patient eligibility to billing and finally review of policies and procedures.

For next year, we will work with the operational team to start building a frequently asked questions area on the Hemophilia Alliance website to remain responsive to these inquiries.

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2022 Wrap-Up
by Johanna Gray and Ellen Riker, Advocacy Consultants

It has been another busy year in Washington (here’s hoping this won’t be true one of these years!), and we’re happy to provide a brief recap of Alliance advocacy activities from this year.

• Alliance Virtual Hill Day: Thank you to the 80 participants representing 29 HTCs and 22 states joined for our 2022 Virtual Hill Day with Members of Congress and their staff members. We provided general education about bleeding disorders and HTCs, discussed federal programs important to our community, including the 340B Drug Discount Program, and shared information about the “alternative funding model” program affecting HTCs and their patients.
• Implementation of the Hemophilia SNF Access Act: As you all know, the Hemophilia SNF Access Act finally took effect in October 2021, and we’ve spent much of this year helping members take advantage of the new policy. We held a webinar in October 2022 with NHF and the American Health Care Association (AHCA, the trade association for SNFs) to share important details on SNF staffing and practices and how the provision of services will occur. A recording of the webinar can be found here. The Alliance is planning a second webinar for HTCs to share their success stories on the placement of Medicare patients in SNFs and billing for treatments under Medicare Part B. Stay tuned for more information.
• Inflation Reduction Act: Congress was consumed this year with whether to pass a large reconciliation bill – it started as the Build Back Better package last year and eventually turned into the Inflation Reduction Act this summer. This large package had many provisions affecting lots of different policy arears but for health care, the banner news relates to new provisions that seek to lower drug costs, including for the first-time giving Medicare authority to negotiate some drug prices. As we have said for years, we have always thought that “drug pricing reform” could bring with it reform of the 340B program, and we are very pleased that our advocacy, and that of our covered entity colleagues, prevented that from occurring. We are always keeping our eye out and will
• Alternative Funding Model Advocacy: We have convened an Alliance/NHF/HFA work group to work on the Alternative Funding problem and have identified a few new advocacy strategies to address the issue. While we are continuing to develop potential legislation to prohibit the practice, we are also pursuing strategies to determine ways that alternative funding schemes could violate existing law. I’ll repeat my request for examples of plan language describing how hemophilia treatments are no longer covered. If you have any patients that have experienced this issue, and if they are willing to share information with us, please let us know. We will continue to update Alliance members as these strategies progress. Please contact us with any questions or concerns!
• PBM Reform: The Alliance did a few different advocacy efforts to spotlight the challenges that PBMs bring to our community, where they often cut HTCs out of networks and are involved in instituting policies that impede access to care for our patients. One that will continue into 2023 is that the Federal Trade Commission is investigating PBMs, and the Alliance submitted a detailed letter outlining all the way that these practices harm our community. Many Members of Congress have indicated interest in considering further oversight and reform of the PBM industry, and we will look for all opportunities to advocate for HTCs in this context.
• Advocacy Committee: Finally, we also created the first Alliance Advocacy Committee this year, which is chaired by Dean Hindenlang and involves several Alliance members from across the country. The point of the Committee is for more members to have input on Alliance advocacy activities, helping us identify problems facing HTCs and to help to develop solutions. We plan to hold Town Halls in early 2023 so that more Alliance members can get involved in our work – stay tuned for more info on those!

We want to close by wishing everyone a restful holiday break and a happy and healthy new year! We will do our best to help Alliance members navigate the start of the new Congress and all that 2023 will bring and thank you in advance for your continued advocacy on behalf of the community!

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Recap of Payer Activity
by Jeff Blake, Senior Vice President Payer Relations

2022 was another busy year for the Payer Team. Our focus this year was to increase the number of HTC members that participate in our Hemophilia Alliance Network Services (HANS) PPO Network and enhance our relationships with the payer community. We’ve had success promoting The Alliance Pharmacy (TAP) as an HTC contract pharmacy option and backstop for our HANS PPO efforts. We also focused on gene therapy strategies with our payers, and have developed a gene therapy single case agreement, contract pharmacy and infusion and medical services templates that support the hub and spoke model for gene therapy. We continue to collaborate with NHF and HFA on Copay Accumulator and Maximizer programs, Alternative Funding Programs and other healthcare policies and issues.

We continued to see growth in our HANS PPO Network this year. We now have 42 HTCs participating in our network and we are working with several other HTCs to finalize participation agreements. While this growth has been good, we have a long way to go to have a strong national HANS PPO Network to market to payers. To have a solid national presence we need to have at least 80 HTCs in the HANS PPO Network in order to appeal to the larger payers. We continue our efforts to make the HANS PPO Network the network of choice for payers to contract with HTCs and their pharmacy programs in markets where HTCs struggle to gain access to patients for factor dispensation.

During 2022, we have developed and enhanced many payer relationships. We now have six (6) HANS payer contracts with CareSource, Archimedes Rx, AscellaHealth, Security Health Plan, Centivo, and AultCare. In addition to these payer contracts, we continue to increase the number of insurance brokers and consultants, insurers, mid-tier PBMs, third party claims administrators, self-funded employer health plans and reinsurance/stop loss carriers we work with. Over the last five (5) years we have been able to bring back more than 42,000,000 bleeding disorder product units back to the HTC pharmacy programs and we want to work with our members to significantly increase this number over the next few years. We are currently working on payer opportunities for our members that account for more than 70,000,000 units.

We have also been working with State Medicaid Agencies and private payers to cover DDAVP intranasal spray and continue to work on the Skilled Nursing Facility (SNF) Access Act with HTCs and the trade association that supports SNFs.

Additionally, we are seeing an increased interest by Medicaid agencies in establishing a Preferred Drug List (PDL) for factor agents. This is accomplished by the states by “bidding” for supplemental rebates from the manufacturers. If a PDL is established, the PDL frequently allows grandfathering for patients already on an established therapy, but we need to assure that is a consideration in the process. Please watch for activity in this area and let us know if this is occurring in your state.

Thank you for your support in our Payer efforts! We look forward to working with you to make 2023 an even more successful year and working together to grow your pharmacy programs.

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Hemophilia Alliance Foundation: Announcing Project and Patient Assistance Grants!

Starting December 1st applications will be available on-line for the Hemophilia Alliance Foundation 2023 Project and Patient Assistance Grants. Since 2009, the Alliance Foundation has awarded over $4 million in grants to help 140+ chapters, treatment centers, and national community organizations serving persons with heritable bleeding and thrombotic disorders. The cycle of funding currently available is for the following two types of grants:

• Project grants meant to enable eligible organizations to build on their capacity to achieve and expand their mission
• Patient assistance grants meant to render direct patient/family financial assistance through eligible organizations to alleviate financial hardship as a result of, or which impacts on, the management of a bleeding or thrombotic disorder.

To be eligible the applicant organization must serve persons with heritable bleeding and thrombotic disorders and operate under IRS tax exemption 501(c)(3) or 170(c)(1) or other nonprofit status. The deadline for application submission is January 31, 2023, and must be submitted directly on the Hemophilia Alliance Foundation website.

For 2023, the ceiling for grant applications is as follows:

• Local applicants (e.g., chapters/member organizations, HTCs): $8,000
• National organizations, and the eight HHS-designated federally-funded regional core coordinating centers: $10,000

Applications for project grants should demonstrate clear, measurable outcomes and a strong commitment to the heritable bleeding and thrombotic disorders community. The patient assistance grant application has been shortened this year, but requires submission of the organization’s patient assistance policy.

Organizations interested in submitting applications should review the 2023 Grant Guidance thoroughly before finalizing their applications. See our website at https://hemophiliaalliancefoundation.org/grant-information-main/project-patient-assistance-grant-information for more information and apply on-line today!

If your organization–or an organization you know–is interested in applying but feels like it does not have the capacity or expertise to do so, please reach out to Brenda Riske, HAF Chair, at brendariske@hemophiliaalliancefoundation.org! We can direct you to additional resources that will help you submit a strong application.

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Team Alliance Contact Information

We work for you! Please don’t hesitate to contact any of us with any questions or concerns:

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