Notes from Joe
New Year, New Faces, Same Commitment to Our Members
By Joe Pugliese
Happy New Year to everyone! I’m writing this just after we concluded a successful Alliance Board Strategic Planning Retreat. I’m pleased to be able to provide everyone with an update on Alliance plans for 2019.
I have to begin by recognizing the new Alliance Board Executive Committee and outgoing Board members who have devoted so much time and energy to the Alliance over the years. The new Alliance Board Executive Committee is: Chair – Jennifer Borrillo, Tulane; Vice Chair- Heidi Lane, Intermountain Healthcare; Treasurer – Eric Gray, Indiana Hemophilia and Thrombosis Center; and Secretary – Ralph Woods, Blood Center of Wisconsin. Jennifer, Heidi, Eric and Ralph have all served on the Board for many years and are deeply committed to ensuring the success of the Alliance as an organization and more importantly, the success of our members HTCs. Beth Sandon-Kleiboer from Helen Devos Children’s Hospital is rotating off of the Board after several years of service and Marisela Trujillo from Gulf States is ending her term as Chair and will serve one additional year as Past Chair. We thank Beth and Marisela for excellent service to the Alliance. We are also adding a new Board Member, Dr. Stacy Croteau, who is introduced in more detail later on in the Newsletter.
Now, to our plans for 2019. The Board and Alliance staff and consultants met for two days to discuss goals and activities in four broad areas:
- Payer Activities: The Alliance Payer Team will expand its work to educate payers about HTCs and promote the many benefits of contracting with them. We will educate our members and payers about how related services such as Hemophilia Alliance Network Services (HANS) and The Alliance Pharmacy (TAP) can help us achieve our goals of having HTCs be in-network providers for as many patients as possible. We are developing innovative payment strategies to ensure adequate reimbursement by Medicaid programs. We will also seek to expand our work with NHF and HFA on their payer activities, since they are important partners in payer education efforts.
- Advocacy and Legal Activities: The Alliance Advocacy and Legal Teams will continue advocacy to ensure the sustainability of the federal program and HTCs’ ability to participate and use program income to strengthen comprehensive care for patients. In addition, we will also continue working with individual centers on their 340B Program operational issues, to help them advocate to maintain their HM designations, and to address Medicare and Medicaid reimbursement issues. We are evaluating new policy solutions to oppose discriminatory reimbursement policies for 340B providers by public and private payers and to expand access to Skilled Nursing Facilities (SNFs) for HTC patients enrolled in Medicare. Finally, we will continue working with NHF and HFA on access to insurance issues, such as related to the Affordable Care Act and patient cost-sharing issues such as co-pay accumulators and out-of-pocket caps. I’ll conclude the advocacy wrap-up by sharing two recent comment letters that we have filed – one advocating for Medicaid managed care policies to promote access to HTCS, and one supporting the bleeding disorders objectives included in the Healthy People 2030 Framework.
- Communications Activities: The Alliance Communications team will continue its work to develop tools to educate members, such as webinars, Member Meetings and this Newsletter. The team is also exploring technological solutions to assist members in operating their centers since CPR+ is being phased out and centers have additional needs, such as online bleed logs. Finally, the team is developing talking points to assist members in working with their institutions and advocating for resources for their centers. We are always open to your ideas for additional tools or improvements to our current activities.
- GPO Activities: The Alliance will continue our efforts to negotiate with manufacturers so that HTCs pay the lowest possible prices for bleeding disorders treatments. The team is also exploring ways to expand the services and products available to HTCs to strengthen them in the face of future changes to bleeding disorders treatments.
As you can imagine, we had a lot to discuss and have a very full plate of activities planned for this year. We will be releasing more details about all of these initiatives moving forward and hope that you will always remember that you, our members, are at the core of our work. Please don’t hesitate to reach out to me if you have ideas for additional ways that the Alliance can assist you. WE WORK FOR YOU!
Alliance Board Update
Featured Board Member
By Stacy E. Croteau, MD, MMS, Hemophilia Alliance Board Director, January 2019
We are in the midst of a transformative era for the treatment of patients with hemophilia and other bleeding disorders. The availability of new factor concentrates and non-factor replacement therapy as well as the promise of gene therapy and other novel therapeutics provide an opportunity for tailoring management for our patients to further improve bleed prevention, reduce treatment burden, and enhance lifetime wellness.
As we venture into this exciting time of novel treatments, access to quality, longitudinal, specialty care continues to be of upmost importance for our patients. Our national network of federally-supported hemophilia treatment centers (HTCs) provides an integrated care model for patients with hemophilia, VWD, and rare bleeding disorders with services extending in many cases to individuals with clotting disorders and other blood disorders as well. This network of HTCs not only facilitates expert clinical care, but also leads surveillance and clinical research efforts to further characterize the changing natural history of the burden of bleeding disorders on musculoskeletal health, cardiovascular health, and other co-morbidities. The availability and routine use of factor replacement therapy (and now new therapies) affects both acute and long-term clinical outcomes and influences healthcare needs over the course of a patient’s lifespan. Additionally, the improved recognition of women with bleeding disorders and importance of a multidisciplinary approach to their accurate diagnosis and management has led to the further expansion of HTC services and inclusion of additional members to the core team including gynecology, pediatric gynecology, and adolescent medicine.
HTC Factor Programs are critical to the development and sustainability of HTCs and their specialized care programs for these often complex patients, in particular, the many services and patient touchpoints that are provided by the HTC teams outside of billable practices. The HTC Factor Programs facilitate clinical team outreach to sites remote from the main HTC where patients would otherwise struggle to access these specialty services as well as education on bleeding disorders and their management and advocacy efforts at the local, regional, and national level.
Your board is committed to the bleeding disorder community (clinicians, HTC staff, researchers, educators, patients and families) in 2019 and beyond. I am honored to join this team and further energize the mission to promote the integrated care model of hemophilia treatment centers, advocate for necessary access to healthcare and treatments, support educational programing and awareness, and foster growth in the collaboration among HTCs, payer groups, and research and patient advocacy organizations.
Dr. Croteau is a pediatric hematologist and clinical investigator at Boston Children’s Hospital and an Assistant Professor of Pediatrics at Harvard Medical School, where she specializes in bleeding and clotting disorders. She leads the Hemophilia/VWD program at Boston Children’s Hospital/Boston Hemophilia Center and is the Regional Medical Director for Region I. Dr. Croteau serves as PI for several investigator-initiated and industry-sponsored clinical trials in bleeding disorders. She has published over 20 original research and review articles in peer-reviewed journals and presents nationally and internationally on a number of bleeding disorder topics for both medical professionals as well as the bleeding disorders community.
We Need YOU for the Alliance Hill Day!
By Johanna Gray and Ellen Riker
With dozens of new Members of Congress in Washington, as well as potential activity on a number of policy areas relevant to HTCs and the bleeding disorders community, such as access to insurance, 340B reform, drug pricing and funding for hemophilia programs, we think that our Alliance Washington Day is as critical as ever. We need as many HTCs as possible to come to DC to participate in the Members Meeting and then join us in educating Congressional offices about the importance of the 340B Program to HTCs and the bleeding disorders community.
We know that Alliance members often have questions about participating in Alliance activities in Washington. Please read on for an article from Issie Karan about lobbying vs. educating on Capitol Hill, which is a common concern. We will also be holding an Alliance webinar in February to discuss the logistics and substance of the Alliance Hill Day and answer any additional questions you may have. Please stay tuned for more information. Please feel free to contact us with any additional questions in the meantime. We look forward to seeing you in Washington in April!
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Telling Your Story Isn’t Always Lobbying
By Elizabeth “Issie” Karan, Feldesman Tucker Leifer Fidell LLP (FTLF)
The Alliance Washington Days are visits to educate members of Congress about hemophilia, Hemophilia Treatment Centers (HTCs), and other matters related to our operations. These meetings do not involve influencing legislation and, as such, are not lobbying. Rather, HTCs focus on educating members and staff that HTCs are participants in the 340B program, and that 340B program income plays a vital role in your ability to provide high-quality, comprehensive care to the bleeding disorders community. If there are HTCs that cannot afford to attend the member meeting in April, that will be held in conjunction with Capitol Hill Day, the Alliance will be accepting requests for financial assistance for travel expenses to come to Washington DC.
HTCs can and should engage in advocacy, but many HTCs have questions regarding whether and how they can advocate. First, you should know that “lobbying” has a specific definition according to the IRS. Lobbying means attempting to influence legislation, which the IRS defines to include action by Congress, any state legislature, any local council, or similar governing body, with respect to acts, bills, resolutions, or similar items (such as legislative confirmation of appointive office), or by the public in referendum, ballot initiative, constitutional amendment, or similar procedure. An organization will be regarded as attempting to influence legislation if it contacts, or urges the public to contact, members or employees of a legislative body for the purpose of proposing, supporting, or opposing legislation, or if the organization advocates the adoption or rejection of legislation.
However, not all advocacy is lobbying and even 501(c)(3) organizations may be involved in public policy without the activity being considered lobbying. For example, organizations may conduct educational meetings, prepare and distribute educational materials, or otherwise consider public policy issues in an educational manner without jeopardizing their tax-exempt status. For example, congressional visits that educate members and their staff about the role of HTCs in providing comprehensive care for the bleeding disorders community and discuss how 340B program income enables that care do not count as lobbying.
For HTCs within a larger institution, your parent organization likely has policies and procedures, and potentially staff, for advocacy and lobbying. We recommend familiarizing yourself with your organization’s approach and staff. Likely, any advocacy staff will enjoy learning about your engagement and commitment to your patients. However, the Hemophilia Alliance is always here to answer questions or provide additional detail for this staff.
Reminder: Recertification Deadline Approaching
As you likely know, the 340B Program HRSA Grantee Recertification deadline is right around the corner. See below for details from HRSA about the process including an upcoming webinar. From the Alliance perspective, we want to encourage everyone to recertify as early as possible to ensure that everything runs smoothly. We also want to take this opportunity to remind Alliance members about the top three reasons why maintaining your HM designation is so important for HTCs:
- Your center must have an HM designation to be a member of the Alliance and benefit from all of the activities described above, including educational meetings and webinars, assistance from Alliance legal counsel on operational questions, payer activities to promote contracts with your HTC, and advocacy on behalf of HTCs. We know that these services are critically important to our members.
- Your center must have an HM designation to be able to be a participating member of the Alliance, which gives you access to the sub-ceiling discounts negotiated by the Alliance GPO. These discounts allow centers to save significant sums of money, allowing you to share savings with public and private payers while ensuring adequate program income revenue to fund your center’s activities.
- Your center’s HM designation is the best and only way to ensure that income generated from 340B sales of hemophilia treatments is reinvested back into an HTC. The HM designation allows enforcement of grant guidance that requires funds to be spent to support your center and the patient services you provide.
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Email from OPA about 2019 HRSA Grantee 340B Program Recertification
Dear 340B Stakeholders,
The 2019 340B Program HRSA Grantee Recertification period for Consolidated Health Centers, Federal Qualified Health Center Look-Alikes, Ryan White, Comprehensive Hemophilia Treatment Centers, Native Hawaiian, Black Lung Programs, Urban Indian, and Tribal Compact 638 will be January 28-February 25. There will be a recertification webinar held on January 23, 2019 from 1-2pm EST. I will send a separate email with all the information required to access the webinar.
Prior to being able to recertify, Authorizing Officials (AOs) and Primary Contacts(PCs) must set up a user account in the 340B Office of Pharmacy Affairs Information System (340B OPAIS). Failure to set up user accounts will result in not being able to view accounts or conduct recertification, thus removal from the 340B Program. AOs and PCs must create individual user accounts, they will not be able to share access. There have been some enhancements to OPAIS since the last recertification period but the process of recertification remains the same. If any contact information has changed or new ones need to be added, please let me know prior to the start of recertification.
For assistance with the 340B OPAIS, I strongly encourage you and the covered entities to utilize the online help that is available for your convenience. HRSA also has information and tutorials available on our website at https://www.hrsa.gov/opa/340b-opais/index.html. For further assistance please contact the 340B call center operated by the 340B Prime Vendor Program at email@example.com or 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. EST).
LCDR Samuel N. Cardarella RN, BSN
Program Management Officer, Operations Branch, Office of Pharmacy Affairs
Health Resources Services Administration
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Please Register for the Spring Meeting!
By Sean Singh
Our Spring meeting will be held in Washington in conjunction with our Hill Day this year. We realize that combining the meeting and Capitol Hill Day visits is very convenient for our members who have limited time to travel – it allows you to participate and learn at the member meeting and then also educate policymakers about HTCs and our community.
To register your attendance and make your hotel reservation, please click here.
We will be sending out a Draft Agenda next week but here is the general schedule for the event:
Sunday April 28th
Hemophilia Alliance Board Meeting
Networking Reception – This session held in the evening gives you the opportunity to network with peers and discuss issues that are pertinent to you and your centers. It leads to topical conversation and a dialogue that benefits our community.
Monday April 29th
General Meeting – The daylong session will be filled with updates from the Alliance on all of the challenges, opportunities and threats facing HTCs and strategies to address them. We expect that this session will be lively and interactive.
Networking Dinner and Hill Day prep – This session will provide all of the details and training you need to meet with Members of Congress and their staff member to educate them about your centers, patients and the community. Telling your story has never been easier with the guidance of our Advocacy team led by Ellen Riker and Johanna Gray.
Tuesday April 30th
Hill Day – Following a breakfast briefing, we will head in teams to Capitol Hill to visit members of the House of Representatives and Senate and their staff. We will schedule your appointments and provide you with information that will make the day’s visits easy and enjoyable. Meetings will end in the late afternoon. Return trips from Washington DC should be planned for Tuesday evening or Wednesday.
Team Alliance Contact Information
We work for you! Please don’t hesitate to contact any of us with any questions or concerns: