August 2023 Newsletter

In this Issue…

Notes from Joe
· Coming Together

Washington Update
· Congress Seeks Input on 340B Policies and Drug Shortages

Legal Update
· Detrimental Impact of Medicaid Unwinding

Notes from the Community
· Calling All Pharmacists – Do You Have Your Global Location Number?
· HTC Challenge & Unite for Bleeding Disorders Walk program update
· Linda Gammage Social Worker Conference Planning Committee Update
· Hemophilia Alliance Travel Fund Supports Participation in World Federation of Hemophilia Events
· Global Hemophilia Report Podcast on Telemedicine

Payer Update
· Commercial Gene Therapy Options/Disrupters

Alliance Update
· Hemophilia Alliance Crossword and Event Reminders

Team Alliance Contact Information

Notes from Joe

Coming Together
by Joe Pugliese, President and CEO

The National Hemophilia Foundation’s, annual Bleeding Disorders Conference, (NHF, BDC) returned to pre-pandemic levels for crowds and interactions. Len Valentino, NHF President and CEO, and his team celebrated its 75th anniversary by introducing a NEW name and logo for the organization – National Bleeding Disorders Foundation. NBDF is to be applauded for a great meeting as it moves the bleeding disorder community into the future, by building on the success the organization has historically enjoyed.

The Hemophilia Alliance was well-represented at this meeting with Alliance Staff, Board Members and HTC Members attending events throughout the conference. Here are the highlights:

  • Preconference meetings started on Wednesday, August 16, on state-based advocacy and public policy and access, which Alliance members attended and served in speaking roles.
  • As usual, the Alliance hosted the annual chapter luncheon, and presented its 2022 Innovation Grants from the Hemophilia Alliance Foundation (HAF). HAF was established as an independent organization that receives a grant from the Hemophilia Alliance. We created a separate foundation to insure that there was a community wide board to oversee grants to Chapters, HTC s and regions. To learn more, visit the website at Grant recipients for 2022 are:
  • Aging Together prepared by the Hemophilia Foundation of Michigan – presented by Susan Lerch, Executive Director, Hemophilia Foundation of Michigan
  • VainSim – Venous Access Infusion Simulator prepared by Orlando Health and Inspiration – presented by Keely DeGroot, Director, Innovation Design & Research, Orlando Health, Arnold Palmer Hospital for Children
  • Access to Care for Women and Bleeding Disorders prepared by CHES Foundation – presented by Connie Montgomery from the CHES Board of Directors
  • Johanna Gray and I presented at the Fifth Annual Grifols Medical Preconference Symposium: Perspectives on the HTC Model and HTC sustainability.
  • Jeff Blake represented the Alliance at numerous CCSC sessions throughout the conference.
  • Thursday night, NBDF and the Alliance hosted a reception for the winners of the Wall of Walkers, recognizing the HTCs that raised the most funds for the Unite walk campaign.
  • Friday morning, Alliance leaders met with Eric Stolte, President, and Alain Baumann, Executive Director, and numerous staff of the World Federation of Hemophilia (WFH) to review our past collaboration and discuss future opportunities. Sean Singh serves on the board of WFH USA.
  • Also on Friday, Jeff Amond from the Alliance Team was a panelist at the BDC Session – Passion to Profession: Exploring Careers in Health Care. Each Panelist discussed their career in health care and what led them to a career in Bleeding Disorders.
  • Saturday morning, I was pleased to attend the MASAC meeting. I presented on the value of the Alliance brings to the community and highlighted the upcoming Physician and Administrator meetings the Alliance was hosting. The Alliance is the sole outside sponsor the NBDF MASAC meeting. Kollet Koulianos, a new consultant on the Alliance team, presented later in the day on the ongoing challenges affecting patient access and what we are doing to address those issues.

I also want to recognize the reception for the National Youth Leadership Institute (NYLI) sponsored by the Hemophilia Alliance. NYLI provides young people (18-24 years old) in the bleeding disorders community with leadership opportunities to encourage personal growth, effect change, and positively influence others. This event will be highlighted in the September Newsletter. It is a logical extension of the NBDF’s plans for the future.

Last but certainly not least, the recently renamed and expanded Members and Community Relations team members had some fun while at the Alliance Booth at BDC. Who wouldn’t look to this group for guidance on addressing challenges you face in your HTC or chapter!

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Washington Update

Congress Seeks Input on 340B Policies and Drug Shortages
by Ellen Riker, Hemophilia Alliance Advocacy Consultant

Senate RFI on 340B – Last month we reported on a Request for Information (RFI), issued by a bipartisan group of Senators, including Senators Tammy Baldwin (D-WI), Shelley Moore Capito (R-WV), Ben Cardin (D-MD), Jerry Moran (R-Ks), Debbie Stabenow (D-MI), and John Thune (R-SD), seeking ideas for how Congress can “further the original intent of the 340B program, strengthening the program’s ability to support entities serving eligible patients.”

The Hemophilia Alliance submitted a letter, developed by the Alliance staff leadership, board and the Artemis Policy Group team. The letter highlights the importance of the 340B Program to the HTCs and responds to the Senators specific questions on potential policy changes related to contract pharmacies, HRSA/Office of Pharm Affairs limited regulatory authority, requirements on the use of program income and issues related to PBMs discriminatory practices.

Other responses to the Senate RFI can be found at It is not clear how quickly or if the group of Senators will compile the comments received and develop legislation. The group is seeking solutions that would be accepted by a majority of stakeholders in the program.

House Committee Seeks Input on Drug Shortages – On July 28, the Chair of the Energy and Commerce Committee, Cathy McMorris Rodgers released policy proposals to address recent drug shortages in the US. The Committee has held multiple hearings and sought input through a Request for Information released earlier this summer. The policy changes under consideration would impact FDA authority as well as Medicare, Medicaid and 340B.

The focus of the proposed 340B changes are:

  • Exempts generic, sterile injectable drugs with at least one indication for a serious disease or condition that are made by more than one manufacturer from being required to provide 340B rebates.
  • Requires the Government Accountability Office (GAO) examine the number of generic drugs that are subject to 340B penny pricing, or that have costs equal to $1 or less, and evaluating the number of such drugs that have experienced shortages within the past decade.
  • Tasks the Health Resources and Services Administration (HRSA) with issuing guidance to covered entities on permissible ways to share drugs during shortages without violating prohibitions on diverting drugs purchased through the 340B Program to patients not otherwise eligible in the Program.

Other policy issues of interest to HTCs include:

  • Requires CMS to gradually phase-out the rebate reduction or waiver for drugs exiting a shortage. Currently, there is a 75% reduction in their penalty in the first quarter post-shortage; a 50% penalty reduction in the second quarter post-shortage; a 25% penalty reduction in the third quarter post-shortage; and a 10% penalty reduction in the fourth quarter after a drug comes out of shortage for Part B drugs and a 40% penalty reduction for Medicare Part D drugs. Additionally, HHS cannot condition waivers or reductions of the rebate penalties on the duration of a supply chain disruption or shortage.
  • Requires HHS to study Medicare reimbursement of generic sterile injectable drugs, and other Part B drugs in shortage, for the purpose of recommendations on how to transition these drugs to market-based pricing.
  • Requires CMMI to test market-based pricing reimbursement policy for generic sterile injectable drugs, which will receive payment based on commercial net pricing or a drug’s wholesale acquisition cost (WAC).
  • Requires HHS to study Medicare coding policies for generic sterile injectables and other Part B drugs in shortage, for the purpose of providing recommendations to update Medicare billing and coding policies to mitigate drug shortages.
  • Requires that hospitals, on their Medicare Cost Report, must report remuneration from GPOs, including remuneration tied to an ownership stake in a GPO, as a condition of participation in Medicare.
  • Requires the Medicare Payment Advisory Commission to make recommendations for changing the add-on payment for Medicare Part B drugs to a flat fee-based payment from the current structure, which bases the add-on payment as a percentage of a drug’s price.

To improve transparency, the legislation:

  • Requires Group Purchasing Organizations to report annually to the HHS OIG and the HHS Secretary their written agreements and disclosures for the purpose of review under the safe harbor.

With regard to the FDA, the legislation:

  • Allows 503B compounding facilities to compound a drug within 30 days of appearing on FDA’s drug shortage list and to distribute and dispense a compounded drug within 180 days of such drug appearing on the drug shortage list.

A section-by-section analysis of the legislative concepts can be found at Stop Drug Shortages Act SBS ( The call for input as well as links to the draft legislation and hearing records can be found at Chair Rodgers Unveils Proposal to Address Root Cause of Drug Shortages Facing American Patients (

The Alliance Advocacy and Payer Committees will be meeting to review these proposals and to develop a response to the request for comments, which will be shared in the next Newsletter.

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Legal Update

Detrimental Impact of Medicaid Unwinding
by Elizabeth “Issie” Karan, Hemophilia Alliance Legal Counsel

As a reminder, as part of the COVID-19 public health emergency (PHE), state Medicaid programs were not allowed to conduct the typical, annual re-determination process for beneficiaries (i.e., state Medicaid programs could not remove anyone from their rolls). Now and over the next nine months, every single person enrolled in Medicaid – currently approximately 90 million people – will need to have their eligibility redetermined. And the process is not going well.

Last month, the Centers for Medicare & Medicaid Services (CMS), with the Department of Health and Human Services (HHS), released its first monthly Medicaid unwinding data report. According to the report, more than 3.8 million people lost Medicaid coverage over the past few months, likely a significant underestimate given the limited data available. Over 500,000 of those who lost coverage are children. Equally concerning is that most people lost coverage because of administrative issues. Based on the data that the Kaiser Family Foundation has collected, 75% of all people disenrolled from Medicaid had their coverage terminated for procedural reasons, meaning they lost their health insurance because of bureaucratic red tape.

CMS has taken steps to try to mitigate harm cause by Medicaid Unwinding. In June 2023, CMS provided a list of flexibilities and approaches available to states to help minimize procedural coverage terminations. Additionally, on August 9, 2023, CMS sent letters to all state Medicaid agencies detailing the actions required to fix high call center wait times, excessive procedural terminations, and lengthy processing of financial eligibility forms. Patient organizations, including NBDF and HFA, have called on CMS to release monthly data on Medicaid Unwinding more quickly, release detailed information about enforcement, and to fully utilize enforcement authority as passed by Congress.

HTC patients will be impacted by Medicaid Unwinding. To assist your patients with this process and ensure they maintain Medicaid coverage, please review the newly updated toolkit for providers released by the Hemophilia Federation of American and the National Hemophilia Foundation.

If your patients are experiencing challenges with Medicaid Unwinding or for additional information and strategies to address the Medicaid Unwinding process in your state, reach out to your primary contact with the Hemophilia Alliance who can connect you with the team members working on this issue.

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Notes from the Community
  • Calling All Pharmacists – Do You Have Your Global Location Number?
  • by Michael Fusaro, Director of Regulatory Compliance

    The Alliance Pharmacy is working with The Hemophilia Alliance to collect Global Location Numbers (GLN) for each member organization. We are looking to ensure that there is no disruption to member’s ability to order medications after the Drug Supply Chain Security Act (DSCSA) deadline of November 27th, 2023.

    If you don’t know if you have a GLN, you are not alone!

    • First step: call Cardinal/McKessen/AmerisourceBergen (if you have a purchase account with them) and ask your sales rep if they have already assigned you a GLN. Most purchase accounts have been assigned GLNs and you can provide that GLN to other vendors.
    • If you have not already been assigned a GLN:
    • One can be purchased for $30 through GS1us or…
    • Have TAP take care of it for you!!!!!

    Email @Michael Fusaro and arrange for one to be assigned to you free of charge as a member of The Hemophilia Alliance.

    Our goal is to ensure that all Alliance members have their own GLN prior to the November deadline.

    Please complete this form and return it to

  • HTC Challenge & Unite for Bleeding Disorders Walk program update
  • by Karen Bowe-Hause, Director Member & Community Relations

    On Thursday evening, August 17th, the National Bleeding Disorders Foundation (NBDF) Leadership and the Hemophilia Alliance held a special private reception during NBDFs Bleeding Disorders Conference in National Harbor, MD to honor the 2022 winners of the Hemophilia Treatment Center Challenge and their generous support of NBDF Chapters through the Unite for Bleeding Disorders Walk program. Light fare and cocktails were served to celebrate the meaningful collaborative work being done by HTCs and Chapters throughout the country.

    The HTCs and NBDF Chapters listed below were honored guests for the evening:

    1. Orthopedic Institute for Children Hemophilia Program supporting the Hemophilia Foundation of Southern California
    2. Oregon Health & Science University Hemophilia Center supporting Pacific Northwest Bleeding Disorders
    3. Indiana Hemophilia & Thrombosis Center supporting Hemophilia of Indiana
    4. Cincinnati Children’s Hospital supporting Tri-State Bleeding Disorder Foundation
    5. Rady Children’s Hospital supporting Hemophilia Association of San Diego County

    The Hemophilia Alliance, co-presenting sponsor of the Unite for Bleeding Disorders Walk program, was honored for helping NBDF launch and promote the HTC Challenge program. The goal of the program is to increase HTC participation in NBDF Unite Walks and in the 3 years since the program’s inception, the HTCs have raised more than $80,000 for local Chapters. Keep in mind, the 2023 Walk season is just getting started!! HTCs, Keep Walking!!

  • Linda Gammage Social Worker Conference Planning Committee Update
  • by Jeff Amond, Director Member & Community Relations

    The Linda Gammage Social Worker Conference Planning Committee and the Hemophilia Alliance are happy to announce that Diane Bartlett has been selected as the newest member of the Planning Committee. Diane’s 3-year term will start immediately. Please see Diane’s picture and bio listed below.

    Diane Bartlett, LCSW is Program Manager and Social Worker at St. Luke’s Hemophilia Center in Boise, ID. Additionally, she is an Adjunct Professor teaching social work & psychology courses including Gender and Human Sexuality. She is considered a sought-after public speaker and has provided numerous presentations to large groups within St. Luke’s Health System, at community-based health conferences, and at local universities on mental health, medical social work, clinical ethics, and women’s wellness. Originally from the San Francisco area, she attended undergraduate at Texas Tech University and obtained her master’s in social work from University of Texas at Arlington. Over the past 30 years, she has worked as a licensed social worker in Texas, Ohio and Idaho.

  • Hemophilia Alliance Travel Fund Supports Participation in World Federation of Hemophilia Events
  • In its on-line newsletter, the World Federation of Hemophilia (WFH) enthusiastically supported the Alliance Travel Fund, which provides WFH volunteers with the opportunity to attend global events as both presenters and attendees. Most recently, recipients, including a dentist, social worker, and HTC administrator, took part in the WFH Comprehensive Care Summit in Buenos Aires, Argentina. More information can be found at How the Hemophilia Alliance fosters international dialogue – WFH – World Federation of Hemophilia.

  • Global Hemophilia Report Podcast on Telemedicine
  • Several leaders of the Hemophilia community participated in a podcast on telemedicine and its impact on the care of patients with bleeding disorders, sharing both the benefits and challenges of caring for patients using this technology and the need for more research. The contributors on the podcast, which was hosted by Dr. Donna DiMichele and Patrick James Lynch, included Sativa Rangarajan, Michelle Witkop, Dr. Roshni Kulkarni, and Dr. Annette von Drygalski. The podcast can be heard in its entirety at this link: Global Hemophilia Report – Telemedicine for the Care of Hemophilia: What Do We Gain And What Do We Lose?

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Payer Update

Commercial Gene Therapy Options/Disrupters
by Member & Community Relations Team

It has been a very busy and interesting year in the Payer space. With the recent approval of gene therapies for Hemophilia A and B and a pipeline with several other novel therapies, we are seeing new market entrants offering networking and contracting services to a variety of payers in the market.

New entrants offering a hemophilia solution include Evio, Emerging Therapy Solutions (ETS) and Synergie Medication Collective that have entered the bleeding disorders space for network contracting specific to Gene Therapy. These companies have created an opportunity and a threat for HTCs. The Hemophilia Alliance Team has been meeting with these companies to discuss the US Hemophilia Treatment Center Network and its expertise along with the national network contracting options with Hemophilia Alliance Network Services (HANS) for Gene Therapy and other bleeding disorder medications as needed. Having participating contracts with these companies will create an opportunity for HTCs to establish an HTC Centers of Excellence Network for Gene Therapy and at the same time secure network access for other bleeding disorders medications.

In addition to the above networks, an entity called Free Market Health (FMH) has emerged as another disruptor in our bleeding disorder product market. FMH is currently working with Highmark Blue Cross and Blue Shield and Blue Cross and Blue Shield of North Carolina. While the way they intersect with providers is dictated by the respective Plan, FMH’s core business is to establish an online “bidding process” for certain specialty medications (including clotting factor) in a short window of time. This enables the Plan to achieve savings by weeding out high-cost distribution sites rather than explicitly creating a select network. The HANS team is working closely with FMH to understand the model and its potential threat to current HTC volume as well as opportunity to access new volume.

If your HTC or institution has been meeting with these organizations, please contact Jeff Blake at so we can have a solid coordinated effort.

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Alliance Update

Hemophilia Alliance Crossword and Event Reminders
by Marketing & Operations Team

Summer is winding down, kids are going back to school, and in the blink of an eye, the end of the year will be here. Don’t panic!

The Hemophilia Alliance wants everyone to pull up a chair with their favorite tea, coffee, beverage, etc. and enjoy this newsletter with a fun crossword puzzle to brush up on your Hemophilia knowledge (click here for answers). We also want to remind you all of some of our awesome meetings on the horizon that will educate and reenergize you.

The Fall Member Meeting 10/08 – 10/10 in San Antonio, TX is rapidly approaching and we have a packed agenda with guest speakers, interactive breakout sessions, and a wonderful networking dinner, so if you have not registered yet, take this opportunity and mark your calendars now.

Additionally, if you or someone you know at your HTC is a Physician or Business Administrators then we WANT YOU! Get ready to pack your bags for Redondo Beach, CA on 11/10 – 11/12 for this unique Physicians & Business Administrators Meeting. Business Administrators grab your docs and take advantage of this educational opportunity in sunny California, with a specially designed agenda for your needs. Register now and look out for more information.

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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:

Name Email Phone
Joe Pugliese 215-439-7173
Sean Singh 813-748-7226
Jeff Blake 317-657-5913
Jeff Amond 608-206-3132
Jennifer Anders 954-218-8509
Angela Blue, MBA 651-308-3902
Zack Duffy 503-804-2581
Michael B. Glomb 202-466-8960
Johanna Gray, MPA 703-304-8111
Karen Bowe-Hause 717-571-0266
Kiet Huynh 917-362-1382
Elizabeth Karan 612-202-3240
Kollet Koulianos, MBA 309-397-8431
Roland P. Lamy, Jr. 603-491-0853
Dr. George L. Oestreich, Pharm.D., MPA 573-230-7075
Theresa Parker 727-688-2568
Mark Plencner 701-318-2910
Ellen Riker 202-257-6670

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