In this Issue…

Notes from Joe
· Update on Alliance Strategic Planning

Alliance Member Highlight
· Multidisciplinary Care in the Management of Heavy Menstrual Bleeding and Blood Disorders

Legal Update
· The Do’s and Don’ts of Contract Pharmacies in 340B Discount Drug Program for HTCs

Washington Update
· Preparing for the End of the COVID-19 Public Health Emergency

Payer Update

Notes from the Community
· Announcing the Hemophilia Alliance Foundation 3rd Annual Innovation Grant

Team Alliance Contact Information

Update on Strategic Planning
by Joe Pugliese, President and CEO

The Hemophilia Alliance board and staff meet for our annual but delayed strategic planning session a few weeks ago. The objective was to identify those critical things the Alliance needs to do to support our mission 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.

We are developing a strategic plan to guide our work from 2022-2027, but I’m pleased to share a few initial thoughts.

While the discussion was generally complimentary about Alliance activities to date, the Board and staff also recognize that we need to continually improve our programs and resources. For example, the revolution in novel therapies is accelerating and our HTCs – and the Alliance – will need to evolve to match it. We have been charged with reviewing our current structure and the services we offer to make sure that they best meet the needs of our members.

To help us do that, we are going to try new ways to engage our members – so we can better understand your needs and how we can assist you. For example, we are looking at forming several new committees to give our members more opportunity to be directly involved in setting our advocacy priorities and to help guide Alliance programming. We are also looking to reformat our member meetings to encourage more active participation and more time for you to network with each other. We are also hoping to engage with the regional leadership more regularly.

The point of all of this is because our mission is helping HTCs meet their mission. We know that this involves not only our excellent staff and contractors, but also the support of both our manufacturing partners and national and local patient organizations. We hope to work with you to enable HTCs to not only survive but thrive!

If you want to get more involved in Alliance activities or have ideas of how we can better help you and other members, please don’t be shy! As we say in every Newsletter and every meeting, we work for you!

Finally, I’d be remiss in not saying that our prayers go out to the brave people in the Ukraine, who continue to fight valiantly. I personally encourage everyone to support the members of the bleeding disorder community there and in neighboring countries, where the needs are significant.

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Note from the Editor: We plan to start featuring one Alliance member each month, who will write about an innovative program or strategy they are using. Read on for an article about an innovative program out of the University of Colorado to provide a clinic for people who experience heavy menstrual bleeding. If you have a program that you would like us to highlight, please email Joe at joe@hemoalliance.org.

Multidisciplinary Care in the Management of Heavy Menstrual Bleeding and Blood Disorders

Mission Statement:
The Spots and Dots Clinic aims to enhance the quality of life of individuals who experience heavy menstrual bleeding by providing access to specialty care, state of the art diagnostic testing, and evidenced-based clinical management throughout the lifespan while contributing to the science that guides this care.

Who we are:
Dr. Patricia Huguelet is board-certified obstetrician gynecologist with a focused practice designation in pediatric and adolescent gynecology. She completed medical school at Saint Louis University and residency at the University of Colorado. Since joining the faculty at the University of Colorado School of Medicine in 2008 and Children’s Hospital Colorado in 2010, she has focused her clinical and research interests in heavy menstrual bleeding and blood disorders, particularly in adolescents and young adults. She has been the primary gynecologist in our multidisciplinary clinic since 2014.

Dr. Genevieve Moyer is a board-certified hematologist/oncologist who completed medical school, internal medicine residency and chief residency at Saint Louis University. After completing hematology/oncology fellowship at the University of Colorado, she was awarded the Hemophilia and Thrombosis Research Society’s Clinical Fellowship award in rare bleeding disorders and used that opportunity to work with Dr. Patricia Huguelet to grow what was then the “young women’s bleeding clinic” into the Spots and Dots Clinic. Through her work with biological females with abnormal bleeding, she has cultivated both a clinical and academic interest in improving the diagnosis and treatment of this population.

Origins of the Young Women’s Bleeding Clinic
The Spots and Dots Clinic originated and is still primarily housed at the Hemophilia and Thrombosis Center at the University of Colorado School of Medicine and collaborates with Children’s Hospital Colorado and University of Colorado Health.

The clinic was first developed in 2013 by Dr. Michael Wang, Professor of Hematology, and Dr. Stephen Scott, Associate Professor of Gynecology. In response to their observations of the impact of heavy bleeding on their patient’s quality of life and the challenges inherent in managing patients across medical disciplines, they developed a once-monthly clinic where both specialists could evaluate patients in the same clinical setting. With the presence of both Hematology and Gynecology in the same office, they were able to develop comprehensive treatment plans and follow patients in a collaborative fashion. Through the Hemophilia and Thrombosis center, patients were also able to have access to other ancillary services including physical therapy, pharmacology, and specialized nursing care.

Clinic Growth and the Spots and Dots Clinic
The clinic now provides care under the expertise of Dr. Patricia Huguelet, Associate Professor of Gynecology and Dr. Genevieve Moyer, Assistant Professor of Hematology who both share an interest in caring for biological females with abnormal bleeding. Under their co-directorship, the clinic has adopted its new title of Spots and Dots and increased accessibility by provide weekly clinics in two clinic locations across the Denver Metro Area with options for telehealth to reach others across the Mountain States Region. Services have also expanded to provide access to behavioral health, social work, and genetics counseling. A series of quality improvement initiatives have led to streamlined protocols that allow for more efficient access to medical therapies including hormonal medications for menstrual suppression, both in-clinic and intra-operative IUD insertions, hemostatic agents including intravenous factor replacement therapy, iron infusions, and more.

The Patient Experience
Up to two-thirds of those who menstruate will experience heavy menstrual bleeding at some point in their life. Up to 30% of those with heavy menstrual bleeding have an inherited bleeding disorder. Many patients with heavy menstrual bleeding experience long delays in accessing appropriate menstrual suppression therapies and the appropriate testing needed to diagnose an inherited bleeding disorder if present. While historically the field of hemophilia has overlooked women’s health, in the last decade, medical providers have improved screening techniques for heavy menstrual bleeding and gynecology care is now recognized as a crucial aspect in the management of biological females with bleeding disorders.

Some statements from our Spots and Dots Clinic patients that demonstrate the impact of heavy menstrual bleeding on their life include: “Other doctors kept telling me my bleeding would get better but no matter what we tried they never did,” “I was so tired and so afraid of bleeding into my clothing that I quit dance after starting my period and now it is hard for me to concentrate at school,” “I just want to have a hysterectomy so I don’t have to deal with my periods, even if it means I can’t have my own children.”

The Spots and Dots Clinic acknowledges that the treatment of heavy menstrual bleeding requires care of the whole person and an appreciation for how symptoms impact daily life. The multidisciplinary nature of the Spots and Dots Clinic allows for a comprehensive evaluation of the interaction between the hormonal, anatomical, and hemostatic causes of abnormal bleeding. All patients are seen by a behavioral health expert to screen for depression and to address the secondary impacts of heavy menstrual bleeding. Patients also have access to physical therapy services and a genetic counselor when needed. This collaborative approach allows for a wholistic and personalized diagnosis and management plan. This approach has been shown to improve control of heavy menstrual bleeding which is associated with improvement in various domains of quality of life. Access to specialized bleeding disorder testing also improves diagnostic accuracy to best inform discussions with other potentially affected family members, future family planning, and planning for invasive procedures.

In order to increase patient access to the Spots and Dots Clinic, Dr. Huguelet and Dr. Moyer have reached out to other UC Health, Children’s Hospital Colorado, and Community providers to increase awareness of how to screen for heavy menstrual bleeding and inherited bleeding disorders and how to refer appropriate patients for evaluation. This has increased this population’s access to multidisciplinary specialty care in unprecedented ways that continues to fuel ongoing growth of the clinic.

In addition to its commitment to patient care, the Spots and Dots Clinic also provides patients with the opportunity to participate in clinical studies aimed at better understanding how to best diagnose and manage biological females with heavy menstrual bleeding. Both Dr. Huguelet and Dr. Moyer are actively involved in clinical research endeavors and hope that the work being done in this clinic will not only change the lives of the patients they directly care for, but will also lead to innovations that will improve the quality of lives of patients for generations to come.

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The Do’s and Don’ts of Contract Pharmacies in 340B Discount Drug Program for HTCs
by Elizabeth “Issie” Karan, Legal Counsel

The Office of Pharmacy Affairs (OPA) within the Health and Resources Services Administration (HRSA) oversees the 340B Discount Drug Program, and contract pharmacies operations. HRSA released guidance on contract pharmacy operations in 2010 which allows for the utilization of multiple contract pharmacies in the 340B Program and provides suggested contract pharmacy provisions (2010 Guidance). In the 2010 Guidance, OPA makes very clear that, even when covered entities utilize a contract pharmacy, they cannot outsource their 340B Program compliance obligations. Meaning, if any duplicate discounts or diversion occur, covered entities, like hemophilia treatment centers (HTCs), will be liable to manufacturers for repayment regardless of what caused the non-compliance.

If you have ever read the 2010 Guidance (which we recommend doing), then you understand that it is just a starting point for contract pharmacy compliance. Generally, HTCs must have sufficient information to meet auditable records standard and audit prescriptions to ensure compliance. Additionally, HTCs should ensure they can recoup damages from contract pharmacies for any failure to meet their obligations under the arrangement. Given the variety of ways contract pharmacies arrangements can operate, we strongly recommend that HTCs get each contract pharmacy agreements reviewed by an expert.

Increasingly insurance companies are creating exclusive networks for the provision of products, leaving contract pharmacies as the only option for HTCs to serve their patients under the 340B Program. Despite potentially having less leverage under these circumstances, HTCs still must maintain 340B Program compliance. From a cost-benefit analysis perspective, in addition to being able to serve patients, some 340B Program benefit from a contract pharmacy arrangement is preferrable to nothing. However, this calculation changes if the contract pharmacy is not a good partner. Therefore, do your homework before signing up with any vendor, especially if that vendor is requesting unnecessary data from your HTC. As always, the Hemophilia Alliance legal and payer teams stand ready to assist however possible.

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Preparing for the End of the COVID-19 Public Health Emergency
by Johanna Gray, Advocacy Consultant

Most experts expect that the COVID-19 Public Health Emergency will end later this summer. First declared in March 2020, it has been extended in 90-day increments since then, with the current declaration set to expire in July 2022. This matters to HTCs because a few important policies will lapse with the end of the PHE, or soon after:

Extension of telehealth services: The really significant expanses of telehealth services during COVID are tied to the length of the PHE, for the most part. This includes removal of the originating site of care requirements, which allows patients to be seen in homes, the allowance of audio-only services, and payment for telehealth services equal to outpatient/office visits. Congress extended some telehealth measures an additional 5 months after the end of the PHE, but that only applies to some of the policies and only to Medicare. Medicaid plans and private payers may follow Medicare’s lead with these extensions, but it’s not unclear. Congress is right now debating various policies to extend the telehealth flexibilities more permanently, but that is still up in the air.

Medicaid: Another very significant policy change relates to Medicaid. At the start of pandemic, Congress required states to provide continuous coverage for Medicaid enrollees until end of the month in which PHE ends in order to receive enhanced federal funding (6.2% increase). When the PHE ends, states must review eligibility of all beneficiaries to determine if they still qualify for coverage. States will lose the enhanced federal match at end of the quarter in which the PHE ends, putting financial pressure on states to move more quickly. In practical terms, this means that it has been hard for states to remove anyone from their Medicaid rolls, but once the PHE ends, they’ll start a process to re-qualify people for Medicaid, for the first time in more than two years. Many people are worried about how this process will go and the potential for families to lose coverage during this redetermination process. One think tank in DC said that that 15 million people could lose Medicaid coverage when the PHE ends so it is a process we will have to watch very closely.

The current declaration goes until July, though it could be ended sooner. The Biden Administration has pledged to give states and all stakeholders 60-days notice before ending the PHE, so we’ll have a bit of advanced warning. In the meantime, we encourage you to start to gather information on your patients enrolled in Medicaid and to learn about anything your state has said about the timing and process for redeterminations. Feel free to reach out to the Alliance advocacy and payer teams with any questions on this. Much more info to come, but we encourage HTCs to start thinking about this now so we can try to make sure that everyone maintains coverage.

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Payer Team Update

The Payer Team has been working with several HTCs on payer relations and payer contracting issues. The results to date have been very favorable. The Team has helped HTCs retain, add and bring patients back on the HTCs Pharmacy Program.

As you can imagine, insurance and utilization data are key elements in solving your payer relations and contracting issues. The Alliance Team is here to help you organize your data and work with you on your payer issues. Below are the key steps in working together on your payer issues.

1. Complete the HTC Patient Insurance & Bleeding Disorder Product Utilization Spreadsheet (available here)
2. Complete the HTC Insurance Questionnaire (available here)

This data will provide you and the Alliance Team the necessary baseline information needed to evaluate your issues and begin creating a strategy to work together to solve your payer issues. However, it is very likely additional information will be needed and may likely include patient protected health information (PHI). Since PHI may be needed to solve payer issues, the Hemophilia Alliance has been signing Business Associate Agreements (BAAs) with HTCs. With signed BAAs the Alliance Team can have patient specific discussions with the insurance payers and insurance brokers/consultants. This has been extremely beneficial in helping solve payer relations and contracting issues.

Do you have payer relations and contracting issues? Contact an Alliance Team member to assist in solving payer issues. Remember, WE WORK FOR YOU!

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Announcing the Hemophilia Alliance Foundation 3rd Annual Innovation Grant

The Hemophilia Alliance Foundation (HAF) is excited to offer its 3rd-annual funding opportunity for the Innovation Grant, previously known as the “Large” Grant. This new name better reflects the intent of the grant and the opportunity it provides. This funding will allow an organization to fund a larger-scope project than what they are able to do with current HAF smaller grants. This will be a one-year grant with projects completed within the year.

The Grant Guidance and online application form are available here: https://hemophiliaalliancefoundation.org/grant-information

Purpose
The goal of this grant is to encourage larger scale, unique, and innovative projects, as well as to serve the community with resources that will improve the lives of patients with inherited bleeding and thrombotic disorders. With this larger funding amount, the Innovation Grant aims to encourage projects that are larger in scope, innovative, and generate resources that can be shared with the whole community.

Requirements

• A non-profit 501 (c) (3) organization
• An organization that has a history and documented track record of serving the inherited bleeding and thrombotic disorders communities
• Completion of the application with all required documents attached
• The grantee will be responsible for a conference call meeting with HAF board members during and/or after project completion to discuss the process (e.g., what worked, what could be improved)
• These funds may not be used in conjunction with grants from the Hemophilia Alliance.

Collaborative projects between more than one organization are encouraged and given higher priority.

Grant funds will NOT be awarded for the following costs:

• Administrative or overhead costs may not exceed 8% of budget
• Basic, laboratory research, or related equipment
• Underwriting or sponsorship of fundraising events
• Construction costs
• Recurring costs, such as:
Office rent and utilities
Monthly phone bills for the applicant organization
Salaries of staff not related to the grant application

Timeline
Applications are currently being accepted through June 30, 2022. The project period will begin on September 1, 2022 and conclude by August 30, 2023.

Questions
If you have any questions about the Innovation Grant process, please contact the Hemophilia Alliance Foundation Grant Committee Co-Chairs, Amy Marquez, at amy@hemophiliaalliancefoundation.org, or Stephanie Raymond, at stephanie@hemophiliaalliancefoundation.org.

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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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