March 2019 Newsletter

In this Issue…

Notes from Joe
· HTCs and Chapters: Natural Partners
· Hemophilia Alliance Foundation Update

Washington Update
· HTCs Are Not Subject to Hospitals’ GPO Exclusion: Apexus FAQ 2653
· Alliance Submits Response to Senate HELP Committee Request for Policy Ideas

Payer Update
· The Covered Outpatient Drug Rule (CODR)…Two Years Later

Alliance Update
· Reminder: Please Register for the Spring Meeting!

Notes from the Community
· Promoting XXcellence in Women’s Health: Optimal Management of Women and Girls with Bleeding Disorders and Blood Disorders

Team Alliance Contact Information

Notes from Joe

HTCs and Chapters: Natural Partners
By Joe Pugliese

We are in the middle of the spring meeting schedule, which features a plethora of meetings: Regional meetings, HFA annual meeting, NHF Hill Day, the Alliance Hill Day and many more. I want to focus on two in this article. The first was the NHF leadership meeting held in Denver Colorado in mid-February and the second is the Hemophilia Alliance Foundation, which met in Atlanta a few weeks ago.

The 52 NHF Chapters around the country offer numerous opportunities to enhance your patients’ care, and we encourage you to partner with your local chapter. While attending the NHF Chapter Leadership Seminar, I had the pleasure of hearing from chapters and community members from all over the country. The theme for the meeting was Sharing Your Story. As I listened to the inspiring stories from community members, it was clear that the support they’ve received from the chapters has been life-changing.

While each chapter may offer different programs and services to the community, they are united in their dedication to supporting the bleeding disorders community. Programs and services may include educational events and retreats, opportunities for in-person and online support meetings, financial assistance, educational scholarships, travel assistance for community members to attend national meetings, advocacy, promotion of research, resource centers, and more.

While having breakfast with some executive directors to hear more about what they do, they expressed interest in collaborating more with their HTCs. It seems it is a natural partnership. Federally-supported HTCs and local, state and national patient organizations are aligned in supporting the needs of people with bleeding disorders and their families. Obviously many of you have seen the benefit of collaborating in a variety of ways.

As I mentioned earlier, the Hemophilia Alliance Foundation Board met recently in Atlanta for the happy job of giving out grants to the bleeding disorders community. It was a record setting year for the number of grants funded, total dollars funded, and most exciting to me, the total number of dollars granted to collaborative efforts between HTCs and chapters. These grants and other financial support for the bleeding disorders community is only available because of the 103 participating members of the Hemophilia Alliance, The Alliance Pharmacy and our contract partners.

I urge HTCs to reach out to your local chapter(s) to see how you can learn more about what they do, share about what your HTC is doing, and discuss opportunities to partner. Chapter leaders, I encourage you to look for ways to support your local HTC. It is no secret that these are challenging times to be a health care provider. Together we can make sure the bleeding disorders community has access to the clinical care they need in a quickly changing health care environment.

Hemophilia Alliance Foundation Update
By Susan Karp, Incoming Chair


The Hemophilia Alliance Foundation board recently met in Atlanta to review and approve a record number of applications and give out a record number of grants. We celebrated the departure of two of the founding board members at our meeting. Joyce Strazzabosco, who had served as the Chair of the Foundation since its inception, and Chad Stevens, also an original board member, are both stepping down but not before creating a solid organization focused on serving the unmet needs of the bleeding disorders community. Joyce will remain with the Foundation in a consulting role for the balance of 2019. Chad will continue to be involved in many aspects of the hemophilia community through his work and many friendships across the country.

I am left with some big shoes to fill but am excited by the opportunity and want to introduce the current board to the community: Brenda Riske, Vice Chair; Crystal Sallans, Treasurer; Michael Craciunoiu, Secretary; Anjali Sharathkumar, Stephanie Raymond, and our two newest members, Maria Manahan and Amy Marquez.

As mentioned in Notes from Joe, we set records across three key indicators in the 2019 grant cycle. Our collaborative grants set a record, with $181,000 being given to collaborative submissions between HTCs and Chapters. The total grant funding increased 25%. This reflects the commitment of the Hemophilia Alliance members to giving back to the community. The goal of these grants since the beginning has to been to improve the operational capacity of the organizations who receive them. We have added elements over time, particularly in the area of patient assistance, but our guiding principle has been to help recipients help themselves.

We have settled on a set time line for grant submission, grant deadline and a timeline for sending the grants out. The grant application for 2020 will be posted on the Foundation website on 12/1/2019 and has to be returned no later than midnight EST on 1/31/2020. There is no requirement to wait till the very last second and submissions in December, 2019, are actually encouraged. The board will review the grant requests between 1/31/2020 and mid-March, 2020, and awards will be mailed out soon after.

Washington Update

HTCs Are Not Subject to Hospitals’ GPO Exclusion: Apexus FAQ 2653
By Elizabeth “Issie” Karan

This week Apexus published a new version of a Frequently Asked Question (FAQ) related to HTCs and the GPO exclusion for hospitals. In the past, HTCs and their related hospital partners struggled to understand previous versions of the FAQ. As such, the Hemophilia Alliance worked with Apexus to update FAQ #2653 to hopefully increase clarity on the policy. FAQ #2653 now reads as follows:

  • FAQ ID: 2653
  • Last Modified: 03/07/2019
  • Q: May a Hemophilia Treatment Center (HTC) that is part of a hospital participate in a GPO for outpatient drugs?
  • A: The answer depends on how the HTC is registered with respect to the hospital.

If the HTC is otherwise an eligible entity and registered as such (with a 340B identification number beginning with HM), then it is not subject to the GPO prohibition and may purchase covered outpatient drugs through a GPO arrangement through its HTC 340B ID and account. This is true whether the HTC is within the four walls of a parent hospital subject to the GPO prohibition or located at an off-site outpatient clinic of a hospital subject to the GPO prohibition. However, in no circumstances may a hospital use the HTCs GPO to circumvent the GPO prohibition.

If the HTC is not registered for the 340B Program as a child site of the hospital, it may use a GPO for covered outpatient drugs provided that it meets all of the following: 1. Is located at a different physical address than the parent; 2. Is not registered on the 340B OPAIS as participating in the 340B Program; 3. Purchases drugs through a separate pharmacy wholesaler account than the 340B participating parent; and 3. The hospital maintains records demonstrating that any covered outpatient drugs purchased through the GPO at the HTC are not utilized or otherwise transferred to the parent hospital or any outpatient facilities registered on 340B OPAIS.

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Alliance Submits Response to Senate HELP Committee Request for Policy Ideas
By Ellen Riker

On March 1, the Alliance submitted its response to the Senate Health, Education, Labor and Pensions (HELP) Committee’s recent request for information from stakeholders on policy ideas to lower health care costs and improve health outcomes. The Alliance provided the Committee with some of the same recommendations that we sent to the Trump Administration in response to the Drug Pricing Blueprint as well as policies that support access to HTC clinical and pharmacy services for patients with bleeding disorders. A copy of the letter can be found on the Alliance website.

Payer Update

The Covered Outpatient Drug Rule (CODR)…Two Years Later
By George Oestreich

Some of you will remember the many discussions that occurred after the promulgation of the Covered Outpatient Drug Rule (CODR). It was a by-product of the Accountable Care Act (ACA) which continues to be heavily discussed in the states. Most of the discussion are now around other aspects of the Act and involve private healthcare insurance coverage, Medicaid Expansion or Medicaid work requirements. However, those of us that are in states where clotting factor is primary covered by fee-for-service (FFS) Medicaid either through the state providing all pharmacy benefits or clotting factor covered separately (there are currently five of these states with two more on the way). They are referred to as pharmacy “carve outs” (not to be confused with 340B Medicaid carve out issues). If the clotting factor benefit is administered through a Medicaid managed care or as a medical benefit, you are less likely to hear much about this issue and will need to monitor more closely for changes.

While clotting factor agents are technically exempt from the CODR, the Centers for Medicare and Medicaid Services (CMS) has told the states they want to know how the states are dealing with the issue. Thus, the clotting factor reimbursement policy should be included in the state plan amendment (SPA) that all states are required to file regarding their conformance to the CODR. Therein lies the problem for some of us: many states are not familiar with issues surrounding clotting factor (and/or the treatment of hemophilia), and if 340B policy issues get introduced into the discussion, things get even more confused. This is especially true of Hemlibra. Many of you have seen this happening and have rescued the issue from being lumped into the quagmire of the overall pharmacy policy.

Also embedded in the discussion is the Professional Dispensing Fee (PDF), which mandates that dispensing fees must be cost-based and must not include any cost that is not part of the actual handling and delivery of the medication to the consumer. This PDF is usually insufficient to support your cost of providing services. This is the area that the Alliance policy and payer teams talked with CMS about early in 2016. CMS ultimately provided guidance that allows for the other services provided by HTCs to be grouped as disease management (DM) services, which are separately reimbursed. You have and will hear more about this issue soon as we work to secure a DM services study that can be presented to the states as separate deliverable and payable services supporting your Center of Excellence.

We have recently been reviewing all of the state SPAs to see how they decided to cover clotting factor reimbursement. Those policies are all over the map. We will provide our members a list of clotting factor Medicaid fee-for-service reimbursement amounts by state so you can quickly see where your state is. More importantly, as you develop your relationship with your state Medicaid agency, you can discuss these rates and either ask they be supported or ask they be changed to meet the needs of your HTC.

If you are located in one of the over forty states that are predominantly Medicaid managed care (MCO), you are seeing the issues from a different perspective. You may not always know if the managed care company is providing service to Medicaid recipients or only to private sector patients. The Medicaid managed care companies are often listed on the state’s website as are the benefits which they cover (hemophilia as a disease may be carved out). You should ensure you know how clotting factor is covered in your state from a payer perspective (state FFS or MCO) as well as how it is billed (pharmacy or medical).

If clotting factor is being covered by the MCO, you can still impact your reimbursement, access to patients and services you may provide by directly working with MCOs or working with the state to influence their contracts. Your Hemophilia Alliance team can help you access the MCO plans in your state. If you know your state is actively bidding or preparing to bid a MCO contracts, you should use the relationship you have formed. Volunteer or work with them to help set the reimbursement parameters or participate in mandated public hearings. Encourage the MCO to either set the rate at the FFS level (if it acceptable) or at a specific acceptable MCO level. Also encourage the state and MCO to include required disease management services and billable codes for the psychosocial and clinical support services you provide.

As the saying goes, “it’s a marathon, not a sprint.” Maintain and enhance your relationship with your state Medicaid agency and the MCOs. Stay informed about changes in funding, services, access and coverage. Let the Hemophilia Alliance team know of issues you learn about, even if they are only rumors. The team can ferret these out. We are here to serve you and to help you be successful and well-funded. Working together makes each of us stronger.

Alliance Update

Reminder: 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.

For the Hill Day, we hope to have as many HTCs participate as possible so that we can educate as many Members of Congress and their staffs about HTCs as possible! Also, please remember that the Alliance is also encouraging HTCs to invite one of your patients to join us in Washington. If you would like to invite a patient, please contact me.

To register your attendance and make your hotel reservation, please click here.

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.

Notes from the Community

Promoting XXcellence in Women’s Health: Optimal Management of Women and Girls with Bleeding Disorders and Blood Disorders
By Kerry Funkhouser, Executive Director, Foundation for Women and Girls with Blood Disorders


The Foundation for Women and Girls with Blood Disorders (FWGBD) has announced the call for applications for its 2019 Promoting XXcellence in Women’s Health: Optimal Management of Women and Girls with Blood Disorders and Bleeding Disorders research fellowship awards.

The overarching purpose of these awards is twofold: to assist new faculty or fellows in conducting research in hematology and/or in obstetrics/gynecology in the area of bleeding and other blood disorders affecting women and girls, and to further and sustain their research interest in improving the lives of these women and girls.

The specific objectives of the FWGBD Research Awards are to:

  • Create and sustain interest/knowledge of the next-generation of healthcare providers, i.e., physician-researchers working in bleeding and other blood disorders affecting women/girls,
  • Foster collaboration between two core disciplines for WGBD—the Obstetrician/Gynecologist and the Hematologist, and
  • Provide an opportunity for junior faculty or fellows to conduct research in this important area

Since 2016, the program has awarded $160,000 to six recipients. Selected through a rigorous application process, past recipients have participated in research in the following areas: monitoring of reduction of hemoglobin during the menstrual cycle in symptomatic Hemophilia A or B carriers; coagulating disorders in menstruating adolescent females; vaso-occlusive pain associated with menstruation in women with sickle cell disease; and women with antiphospholipid syndrome.

The 2018 award winners and their research projects were:
Special Award Focus Area: Bleeding Disorders Affecting Women and Girls ($35,000) – This Award was made possible through a medical education grant from Shire.

Julia Coleman, MD, Trauma Research Fellow at the University of Colorado in Denver
Project Title: Sex Dimorphisms in Trauma-Induced Coagulopathy: A Mechanistic Exploration of a Sex-Specific Survival Benefit

Award Focus Area: Blood Disorders – all Blood Disorders ($15,000, FWGBD)

Tazim Dowlut-McElory, MD, MS
Project Title: Use of Levonorgestrel-Releasing Intrauterine Device for the Treatment of Heavy Menstrual Bleeding in Adolescents with Bleeding Disorders

Additional information on these awards and the recipients is located on FWGBD’s website at http://www.fwgbd.org/about/research-fellowship-awards

To apply for a research award, eligible applicants must:

  • Submit a complete application (see criteria and application online, fwgbd.org)
  • Be an MD or DO who is an early-stage investigator, or a current fellow in Hematology or Obstetrics/Gynecology
  • Have a research mentor who is senior faculty at the applicant’s home institution for the duration of the award
  • Demonstrate active, working collaboration with a peer in the related discipline—Obstetrics/Gynecology for the Hematology applicant and Hematology for the Obstetrics/Gynecology applicant
  • Have an approved or pending IRB approval at the time of grant application submission

In 2019, three awards will be given – two with a special focus on bleeding disorders and one in the area of all blood disorders. More information can be found at http://www.fwgbd.org/fwgbd-research-awards. Entries will be accepted for the 2019 award through Friday, April 26, 2019.


Team Alliance Contact Information

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

Name Email Phone
Joe Pugliese joe@hemoalliance.org 215-439-7173
Sean Singh sean@hemoalliance.org 727-388-7326
Jeff Blake jeff@hemoalliance.org 317-657-5913
Jeff Amond amond@hemoalliance.org 608-206-3132
Johanna Gray, MPA jgray@dc-crd.com 202-484-1100
Elizabeth Karan ekaran@feldsmantucker.com 202-466-8960
Roland P. Lamy, Jr. roland@hemoalliance.org 603-491-0853
Dr. George L. Oestrich, Pharm.D., MPA george@gloetal.com 573-230-7075
Ellen Riker eriker@dc-crd.com 202-484-1100
Mark Plencner mark@hemoalliance.org 701-318-2910
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Theresa Parker theresa@hemoalliance.org
Karen Bowe
Joel Bellucci webmaster@hemoalliance.org 727-504-0491