Notes from Joe
Looking Back, Planning Ahead
by Joe Pugliese, President and CEO
2021 did not live up to the hype! It was all supposed to be better, starting with the pandemic. Oddly in some ways progress on the pandemic was the highlight of the year. We are blessed in the US with three highly effective vaccines. It is clear that year two of the pandemic has taken a significant toll on everyone but healthcare workers in particular. It is a real tribute to the dedication and resilience of the HTC staffs across the country to stay focused on providing outstanding patient care.
Several in person / virtual meetings got off the ground and hopefully, current, and future variants will be effectively managed through the use of vaccines and some promising treatments. The Alliance is moving ahead with plans for several in person meetings, our annual strategic planning board meeting, our first ever pharmacists CE and our first ever new member meeting all in the first 6 weeks of the New Year. Everyone is clearly tired of virtual meetings. I am hoping we will be tired of in person meetings by mid-year.
Our manufacturing partners have done a marvelous job maintaining an uninterrupted supply of life -saving products for the bleeding disorders community. Many thanks to all of them; they have obviously invested in protecting their supply chains. It helps that they do not use cargo ships.
The Hemophilia Alliance had another very productive year. Our manufacturing partners continue to support our vision of a financially stable, integrated, national network of hemophilia patient care. We were delighted to participate in an effort headed up by Len Valentino MD and CEO of NHF once again confirming the critical importance of this network.
The SNF (skilled nursing facility) legislation that was enacted in 2020 went into effect 10/1/2021. Seemingly getting the legislation passed is the easy part! The Alliance advocacy, legal and payer teams have been hard at work making sure the implementation goes smoothly. The Alliance payer group has also continued to enjoy great success in identifying single case agreements as well as HANS (Hemophilia Alliance Network services) contracts.
The operations team ran a very complicated and busy year of in house and manufacturer webinars and managed the increasingly complicated finances of a growing organization that continues to deliver tremendous value to its members and the larger bleeding disorders community. We also set yet another record for investing back into the community.
Finally, we were able to bring DDAVP NS back to the community in 2021 by working with STAQ Pharma, Inc. The first vials shipped in September. The product was made possible by the Alliance funding the development costs to bring this product to market. The patient organizations put their weight behind the effort to clear regulatory hurdles and we are well on our way to have the product available to all patients in the US. Additionally with the help and support of Robert Klassen, MD, and Alex Wong, RPh, the product should be available in Canada under a special product access program in the near future.
Looking ahead, we have a short list of items to work on in 2022. This is not the full list, of course, but it should keep us busy!
- Protecting program income and adherence to the grant rules
- Addressing alternative funding challenges
- Expanding the clinical footprint for our members
- Support the proposed legislation protecting 340B
- Gene Therapy preparedness, including single case agreements and contract RX
- Sustainability of HTC for years to come
- HTC Growth Initiative leading to more member engagement
- Addressing accumulator adjustor programs
We wish you all a Happy and Healthy Holiday season and hope to see many of you in person next year!
Not the Old, Not the New, but the Necessary: Legal Review of 2021
by Elizabeth “Issie” Karan, Legal Counsel
2021 brought new but also familiar opportunities and challenges in the hemophilia treatment center (HTC) compliance and legal world. While Hemophilia Alliance members always ask insightful questions amidst the larger healthcare landscape’s surprising turns, the pressures of operating a highly regulated grant program in a complex industry often return the legal team’s work to the same authorities and themes. Through both the known and novel, the Alliance legal team works to distill and translate the miasma into useful and actionable guidance for HTCs.
On new subjects, the legal team often collaborated with other members of the Alliance team. We assisted the policy and payer team in preparing for implementation of the Hemophilia SNF Access to Care Act. We advised the Alliance on issues related to DDAVP. We began to prepare for gene therapy by developing legal templates. We provided analysis of state pharmacy laws impacting HTCs’ operations. Additionally, we tracked litigation related to the 340B Program. Although many issues were different, the cooperation and camaraderie of the Alliance team remains.
On the familiar topics, the legal team fielded many members’ questions related to federal grants and the 340B Program. Among other things, in the grants arena, we provided technical assistance on the use of program income, reasonable indirect cost rates, and salary limitations. For 340B, we helped members with policies and procedures, audit protocols, and operationalizing the patient definition. Through it all, we encouraged HTCs to connect with their regional leadership when appropriate and educated members through presentation.
We know 2022 will bring both unexpected and known inquiries and look forward to helping guide the Alliance and its members to the right answers.
Year in Review
by Johanna Gray, Advocacy Consultant
We had an active year in Washington, working to advocate on behalf of HTCs and the broader bleeding disorders community, and doing our best to translate everything happening here for the community. As we look back, here are a few highlights:
- Implementation of the Hemophilia SNF Access Act: We spent a lot of time this year working with our payer and legal team colleagues, as well as our colleagues at NHF, to prepare for the October 1, 2021 implementation date of the Hemophilia SNF Access Act. We have worked together to create a factsheet for members on reimbursement issues associated with the policy change and have been working with the SNF trade association on educational materials for SNFs. We know that many members continue to have questions about how the new policy is being implemented and how to ensure that your patients have access to SNFs if appropriate. Please be in touch with us with any questions and know that we’re continuing to develop materials and will share them as they’re ready!
- Alliance Virtual Hill Day: We had another wonderful virtual Hill Day in 2021 and are so appreciative of our members who set aside time to participate. We both talked about hemophilia and HTC 101, as well as the alternative funding model that is an emerging issue affecting both HTCs and your patients. We’re starting to plan another Virtual Hill Day in 2022 and hope that you will consider joining us! In a way, it is easier than coming to DC, since you only have to set aside a few hours for trainings and meetings, rather than a few days.
- HTC Sustainability: As you know, supporting HTCs in having sustainable programs with adequate funding is at the core of the Alliance’s mission and all of our activities. We are beginning to more formally tackle this on a policy level as well – we have catalogued various threats and opportunities for HTCs and are developing strategies to address them with Congress, the Administration and other stakeholders. Much more to come but please let us know if you have any concerns or policy ideas that you’d like to share with us.
- Changing Washington Environment: Finally, this year has also brought many changes to the broader policy environment including the transition from the Trump Administration to the Biden Administration. Congress has also considered a number of large bills related to COVID-relief, infrastructure and the still-under-debate Build Back Better package focused on “human infrastructure.” We have closely monitored everything happening in DC and have advocated to protect HTCs and people with bleeding disorders throughout.
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 and thank you in advance for your continued advocacy on behalf of the community!
Payer Team Update
by Jeff Blake, Senior Vice President of Payer Relations
2021 was another busy year for the Payer Team. Our focus this year was to increase the number of Hemophilia Treatment Center 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 assisted 8 HTCs with their billing and reimbursement issues and we recently sent out a Billing & Reimbursement Services Survey to determine how we can expand our services to assist member HTCs. We have also been working on our Disease Management Program and our Cost of Dispensing Survey. We will continue these efforts in 2022.
We have seen excellent growth in our HANS PPO Network this year. We now 40 HTCs participating in our network and we are working with several other HTCs to finalize participation agreements. While this growth has been fabulous, 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. We will focus our efforts to make the HANS PPO Network the network of choice for payers to contract with HTCs and their pharmacy programs.
During 2021, we have developed and enhance many payer relationships. We now have four HANS payer contracts with CareSource, Archimedes Rx, AscellaHealth, Security Health Plan and Centivo, and we are very close to finalizing two additional contracts. In addition, 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 four years we have been able to bring back more than 41 million 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 million units.
During 2021, we continued working with HTCs on billing and reimbursement challenges with payers. Today, we have assisted HTC members in collecting over $9 million in outstanding A/R. In addition, we are working on reimbursement of an additional $5.1 million.
We continued the development of a disease management program and Cost of Dispensing Survey. We continued working with Mercer on cost of dispensing data gathering and we planning to complete the Cost of Dispensing analysis in 2022. This is the key first step in finalizing our HTC Disease Management Program.
Finally, we have developed a single case agreement and contract pharmacy template for gene therapy and continue to educate payers on the value of HTCs model of care with integrated pharmacy services. We have also been working with payers to cover DDAVP intranasal spray and we have recently been working on the implementation of the SNF Access Act.
Thank you for your support of our Payer efforts! We look forward to working with you to make 2022 even a more successful year and working together to grow your pharmacy programs.
Alliance Board Update
Update on New and Departing Alliance Board Members
by Eric Gray, Vice Chair
The mission of the Hemophilia Alliance is to work “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”. Per the Hemophilia Alliance by-laws, “The Board of Directors should, to the extent feasible, include members representative of the eight (8) regional networks of hemophilia treatment centers, types of programs, expertise, and experience.”
First, the Hemophilia Alliance would like to express its gratitude to the following departing directors:
Christine Guelcher RN-BC MS, PPCNP-BC served on the Alliance board with distinction, including serving as a mentor for Jeff Blake and Sean Singh. We congratulate Chris, who retired from Children’s National Medical in 2021. She has taken a position with Genentech serving as a Medical Science Liaison in the rare blood disorder division. We wish her all the best and know they are lucky to have her! We look forward to seeing her around in the coming years.
Stephanie Raymond has served on the Alliance board for the last five years. She also served as the Alliance representative on the Hemophilia Alliance Foundation Board. She made the tough decision to step down from these responsibilities while she leads Cascade through an expansion and move into a much larger facility. We are delighted we will have her ongoing support for the Alliance. Cascade as many of you know was one of the founding members of the Alliance.
We also want to sincerely thank all applicants for their interest in serving on the board. We thoughtfully reviewed and considered all applicants in the context of the Mission and by-laws, seeking to most broadly represent our membership as well as diversify our expertise and insight to most strategically address challenges to further our mission.
We are pleased to announce Zack Duffy, MPA and Dr. Michael Silvey have been elected to serve on the Board, with their terms beginning January 2022. Zack is the Program Administrator for the HTC at the Oregon Health and Science University. Zack brings expertise in operating a 340B program via both physician-dispense and on-site pharmacy models, payer and government relations and regulatory oversight. He has been actively involved with Pacific Northwest Bleeding Disorders and the Mountain States Hemophilia Network. Dr. Silvey is the Associate Professor of Pediatrics, Associate Director of the Kansas City Regional HTC, Children’s Mercy Hospital where he specializes in bleeding and clotting disorders. He has published original research and review articles in peer-reviewed journals and presents nationally and internationally on a number of bleeding and clotting disorder topics.
Again, we can’t thank enough the individuals who applied to serve on the board. We may be reaching out to you to assist in serving the Alliance in other ways.
by Sean Singh, Senior Vice President of Marketing and Operations
As we look in the rearview mirror on the past year it has a lot of highs and lows. We threatened you with an in-person meeting only to do the sensible thing and get us together virtually. While I am one for seeing everyone and enjoying the changes to your offices, living room, back yard and virtual beach scape. These daily visits come with a little stress which included am I centered on camera, how good the lighting is, did I remember to comb my hair after I got out of the shower, I am thirsty, when is a good time to take a sip or my very favorite, the many times I am talking away only to be reminded that “Sean, you are muted!” I miss conference calls where I can pace around my living room while focusing on the conversation and really being a part of the dialogue instead of being on “TV.”
As a team, we looked for ways to engage our members and continue to provide valuable information. We did our fair share of webinars and added great content from our manufacturing partners. We listened to your request and provided a nursing Continuing Education session. We are looking forward to offering more in 2022. As we evolve into this new environment of hybrid gatherings and more digital information, we would look to you for feedback on what works and doesn’t.
We are looking forward to looking you in the eye literally in the near future and to reconnecting in ways that will be beneficial to all our members. Here are updates about several of our key activities:
- Harmony in Hemophilia
by Karen Bowe, Director of Community Relations
Harmony in Hemophilia continued its efforts to increase collaboration between our member HTCs and local NHF Chapters and HFA Member Organizations. As we look back, here are just a few of the highlights:
NHF Collaboration: The Hemophilia Alliance launched the HTC Wall of Walkers Challenge, created to encourage HTC participation in the 2021 NHF Unite Walk program, and had the following outcome:
- HTC teams participated in 28 of the 39 total walks, a 17% increase over total HTC teams participating in 2020.
- HTC teams raised more than $27,000 for local Chapters, a 50% increase over the amount raised in 2020.
HFA Collaboration: The Hemophilia Alliance is proud to be the sole sponsor of HFA’s new program acknowledging federally supported Hemophilia Treatment Centers as a vital resource for patient care and aligning with its goal of ensuring sustainability for HTCs and protection of 340B programs. The program will include the following:
- HFA database updates and improvements.
- Creation of an HTC resource page on the HFA website.
- 2 sessions at 2022 HFA Symposium for HTC and Hemophilia Alliance overviews.
- Announcement of availability of resources and website updates in a press release and quarterly Dateline publications.
- HTC clinicians to be subject matter experts at HFA hosted meetings and inclusion in HFAs National Speakers Bureau.
- 340B Basics was presented by Elizabeth Karan to increase knowledge of HTC pharmacy programs and its importance to ensuring sustainability of HTCs. The audience included NHF Chapter leadership, staff, and community members.
- HFA presented “An Introduction to HFA Mental Health and Wellness Task Force” to member HTCs at the Alliance Spring members meeting.
- In a joint webinar with NHF, the Alliance launched the HTC Wall of Walkers challenge to NHF Chapter members as well as to member HTCs at the Alliance Spring Members meeting.
- HTC/Chapter collaboration – In an effort to highlight program development as a result of collaboration between HTCs and local Chapters, the Executive Director of the Illinois Chapter and the Nurse Coordinator of the Maine Medical HTC both presented to NHF Chapter members on the benefits to the bleeding disorders community as a result of collaboration between HTCs and local Chapters.
HTC Growth Initiative: Goal – exploring ideas which ensure sustainability and growth of HTC pharmacy programs and develop plans to overcome obstacles preventing growth within a Center.
- Total of 27 participants from 18 HTCs participating.
- Focus on HTCs dispensing less than 5M units/year.
- Evaluating SWOT plans per HTC.
- 6 meetings total – November through April.
- Intermittent Alliance team meetings to review and analyze responses.
- Final in-person meeting in May to share outcome of monthly discussions and suggest recommendations for pharmacy program growth.
- Data Portal and Center Contacts
by Theresa Parker, Administrator
In the first part of the year, we were working on a new look and function to our data portal. This allowed us to make entering your data more user friendly, as well as allowing us to store the data more efficiently. We saw a 25% increase in members entering data with positive feedback on the changes. We also added a Savings report to the portal so that you can view your centers’ progress at any time that is convenient for you. We would like to add more reports to the data portal that would assist you in analyzing your business. Suggestions regarding these new reports can be emailed to email@example.com.
Also, we continue to strive for up to date and accurate information from our members. We send out a variety of correspondence (yearly center savings letter, membership invoice) and want to confirm we are contacting the proper person(s). A center contact update form is available to you on our website. Go to hemoalliance.org/login. Once you have logged in click on the Alliance Members tab, then select Center Contact Update. You can also contact Theresa Parker, firstname.lastname@example.org or your Hemophilia Alliance primary contact and we would be happy to email the form to you. Thank you in advance for your cooperation.
- Information Technology
by Kiet Huynh, Manager of IT Solutions
It has been a year since I joined the team. My skills have been tested from the beginning and the Hemophilia Alliance team continues to expand my knowledge while I try to keep on top of the current environment. We have made changes to our website, enhanced the member section and continue to look for ways to get information to our members. I am looking forward to the evolution of our meetings as we meet in person and adding a virtual component to some of them. We are trying to keep pace with changes in technology and we hope you share some of your knowledge, good experiences and suggestions on how we can do more for you.
Notes from the Community
Hemophilia Alliance Foundation Announces 2022 Project/Patient Assistance Grant
Are you a nonprofit organization that serves the inherited bleeding and thrombotic disorders community?
Are you looking for additional grant funds to support your patients and community programs?
Of course you are!
The Hemophilia Alliance Foundation (HAF) is pleased to announce that the 2022 Project/Patient Assistance Grant Guidance is now available on our website. Applications are due by January 31, 2022 and must be submitted directly on the website.
Since 2009, the Alliance Foundation has awarded over $4 million to help 140+ chapters, treatment centers, and national community organizations build capacity and support and expand their missions. For 2022, the ceilings for grant applications are 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
Successful applications for both projects and patient assistance programs should demonstrate clear, measurable outcomes and a strong commitment to the inheritable bleeding and thrombotic disorders community. Organizations interested in submitting applications should review the 2022 Grant Guidance thoroughly before finalizing their applications.
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 email@example.com! We can direct you to additional resources that will help you submit a strong application.
Team Alliance Contact Information
We work for you! Please don’t hesitate to contact any of us with any questions or concerns: