February 2023 Newsletter

In this Issue…

Notes from Joe
· Stepping Up Our Game

Alliance Update
· Update on Alliance Meetings for 2023!
· Pharmacist CE Conference 2023 Summary

Legal Update
· A New Era of Conundrums: Contracting with Related Pharmacies to Prepare for Gene Therapy

Washington Update
· HELP Copays Act Reintroduced

Payer Update
· Call the Alliance Bat Phone!

Team Alliance Contact Information

Notes from Joe

Stepping Up Our Game
by Joe Pugliese, President and CEO

Last April the board and staff of the Hemophilia Alliance met to lay out a five-year strategic plan. When the smoke cleared, we came away from the meeting with an impressive list of things we needed to accomplish, with tight timelines and easy to measure metrics. The Alliance team met afterwards to digest the key goals. Our esteemed legal counsel Issie Karan famously commented that it was a c**p ton of work.

The regions have long worked on the concept of continuous improvement. We felt that if we wanted to be able to reach out and assist each HTC, we needed to reorganize and expand our team. The new Alliance organization chart provides greater focus to the entire team. We have renamed the Payer team the Member and Community Relations Team reflecting our constantly growing relationship with all parts of the bleeding disorders community: HTCs, regions, chapters, national patient organizations, payers, THSNA, ATHN, HTRS, WFH, policy makers and manufacturers.

We posted two open positions for Director of Member and Community Relations. We were blessed with over 20 great candidates that went through one or more interviews. We want to thank all the finalists for their interest and expertise, that made making the final decision a challenge. I’m pleased to announce that the Alliance has hired two outstanding candidates who are the best fit and bring the most value for the needs of the organization and our members today. They both come from HTCs, which is ironic but makes sense. They have over 30 years of experience actively managing HTCs and they have outstanding relationships with their local chapters.

We are delighted to have Angela Blue and Zack Duffy join Team Alliance. They will both be starting on April 10th, giving them time to assure a smooth transition from their present roles. They will of course be able to share their decades of operational expertise with the rest of the Alliance team and learn from them as well. The focus of course will be the Alliance members and the broader community.

I always like to benchmark our organization to compared to others in this space that provide services to the HTCs, though it is difficult to do an apples-to-apples comparison. We operate as a 501(c)3, which means that anyone can view our 990s. The relevant other organizational comparisons are difficult because “similar” service providers are private companies, which means that their books aren’t public though they often boast of pouring money back into the HTCs.

Here are the numbers for the Alliance: We saved HTCs $130 million just on GPO contract purchases in 2022. Our payer efforts returned 45 million units of replacement product to the HTCs. We provide operational, legal, advocacy and lobbying support. We also contributed more than $3,000,000 back to the community. Our members paid a total of $466,800 in membership dues. Based on my 44 years of experience in this space and the team we have assembled for your benefit, which has over 200 years of experience in the Bleeding Disorders Community. I know that the Alliance can help you save even more on the administrative side of running an HTC, while growing your market share. This represents a return on investment (ROI) of 27,749%.

We can do more; just give us a call! Why spend money on administrative costs paid to for profit organizations? We would rather see you spend resources on maintaining and expanding the outstanding clinical care for the benefit the bleeding disorders community.

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Alliance Update
  • Update on Alliance Meetings
  • by Jennifer Anders, Manager of Data & Analytics

    The Alliance recently hosted our 2023 Spring Member Meeting in Nashville. We were excited to spend time and listen to great music with about 85 of our members, of which about 12 were experiencing their first Alliance meeting. We were greatly appreciative to have received feedback from almost 62 members on our meeting surveys.

    All presenters did a wonderful job and provided useful information and updates. We did receive helpful feedback that many of you enjoy hearing real world examples from HTCs, and we will continue to encourage these types of presentations in future meetings.

    This was our first meeting that we were able to have smaller breakout sessions and get to hear from individuals on topics such as our Tool Box and Contract Pharmacy discussions. The majority of respondents agreed that the breakout sessions were useful and in future meetings the Alliance will solidify breakout session topics to be available for attendees to select when they register. We also received great suggestions for future break out session topics that we hope to have available for the Fall Member Meeting this year.

    The Alliance values member engagement not only during these meetings but also after, to learn new ways to better support you! We continue to strive to make sure these meetings are aligned your expectations for things like networking and updates in the 340B community. We will also soon share the attendee lists along with contact information for this meeting and future meetings.

    Mark your calendars for our upcoming meetings:

    • Registration is now open for the New HTC Staff Meeting (in New York City, May 10th – 12th)
    • Hill Day (Washington DC, June 12th – 13th)
    • Fall Members Meeting (TBA, October 8th – 10th)

  • Pharmacist CE Conference 2023 Summary
  • by Resham Sahijram, PharmD

    Thank you to our sponsors Takeda and The Alliance Pharmacy for helping us organize the second annual Pharmacist CE Conference which took place from January 25th through January 27th in San Diego, California. There were a total of 30 pharmacists attending in-person and 12 who attended virtually. The conference offered pharmacists 12.5 continuing education credits through excellent presentations by practitioners from all over the nation. Topics discussed were Acquired Hemophilia, PK-Tailored Factor Concentrate Prophylaxis, Real World Experience with Emicizumab, Quality Improvement and Accreditation, Sterile Compounding, Genetics, Von Willebrand Disease, New and Emerging Therapies for Hemophilia, Inhibitors, Lab Values, Physical Therapy, and the Management of Chronic Pain. Each topic was well presented and the audience was very engaged.

    This type of conference allowed us pharmacists in different practice settings to come together and share ideas on how we can better serve this small population. One pharmacist stated, “This conference gave me the opportunity to branch out and meet pharmacists from other regions. Throughout this experience I was able to connect and build professional relationships I can use to advance in ways I wouldn’t have individually. We all have different experiences unique to hemophilia. It was insightful to hear what other pharmacists are doing, leverage their support, and build on each other’s successes. We all hold a different piece to the puzzle and when we connect, we can bring these pieces together and achieve a common goal. I am appreciative of my newfound support system and the opportunity to collaborate with other experienced pharmacists.”

    Another pharmacist stated, “The conference is a great way for pharmacists within the hemophilia treatment center network to stay up to date on topics affecting our community. It’s also a chance to meet and exchange ideas with our peers within pharmacy. I have attended this conference for the past 2 years and it’s been a great experience. I look forward to attending in the future.” It is quite clear that we all can benefit from such an opportunity.

    When asking one of our physician speakers what he thought of this event, he stated “My experience with the conference was excellent. I received a lot of questions that made me realize that we do not take the time to fully educate the pharmacists who fill these medications regularly and appreciate the efforts of this group to fulfill that need. This was also a great opportunity for these pharmacists to network and get a better understanding of how different pharmacies work and how they can optimize their local pharmacy.” This was a great event appreciated by all, and we hope to continue to provide such a great networking event in the future.

    Editors note: The Hemophilia Alliance now has over 25 credits of Pharmacist CE available for Home study available on the Hemophilia Alliance Website. Credits from the 1st Convention are certified through January 2025 and Credits from the 2nd Convention are certified through January 2026. Also, as of December 9th 2022, CPhT credential holders may submit a maximum of 5 pharmacist-specific(P-specific) hours from ACPE accredited providers and CPhT-Adv holders may submit 10 P-specific CE hours from ACPE accredited providers.

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Legal Update

A New Era of Conundrums: Contracting with Related Pharmacies to Prepare for Gene Therapy
by Elizabeth (Issie) Karan and Michael B. Glomb, Legal Counsels

With the dawn of gene therapy, the Hemophilia Alliance is fielding more questions from member Hemophilia Treatment Centers (HTCs) about options for collaborating with in-house and/or institution pharmacies. More specifically, some HTCs have asked what is required, and what is appropriate, in terms of the 340B Program and federal grants compliance.

The Office of Pharmacy Affairs (OPA) allows a covered entity to list an in-house/institution pharmacy as a “shipping address.” However, OPA requires that a covered entity wishing to work with a pharmacy, which is a separate legal entity from such covered entity, have in place a compliant contract pharmacy agreement and list such pharmacy on its registration prior to 340B purchased drugs being dispensed to patients at such pharmacy. Therefore, an HTC with a related in-house/institution pharmacy, which is equipped to store and administer a gene therapy product, may wish to add them as a shipping address on the OPA Information System (OPAIS). Please note that an institutional pharmacy, which is not co-located with the HTC but is part of the same legal entity as the HTC, likely constitutes an in-house pharmacy and be eligible to be a shipping address of the HTC on OPAIS.

Apexus FAQ ID: 1184 states the following:

“Q: How must we register our in-house pharmacy that is a separate legal entity under our 340B covered entity?
A: An in-house pharmacy is not eligible to register as a child site. The in-house pharmacy could be listed as a shipping address. If the covered entity has a contract with the in-house pharmacy because it is a separate legal entity, then it must be registered as a contract pharmacy and may not dispense any 340B drugs until a written contract is in place and the pharmacy is listed as a contract pharmacy for the covered entity on 340B OPAIS.”

Regardless of whether an in-house/institution or contract pharmacy serves HTC patients, the Uniform Grants Guidance still applies to any revenue generated from that arrangement. As we often highlight, the definition of program income states that program income includes “gross income earned by the non-Federal entity that is directly generated by a supported activity or earned as a result of the Federal award during the period of performance.” (See 45 CFR Section 75.2.) Program income rules apply to an HTC, and its institution, regardless of whether it purchases products using its eligibility as an HTC grantee or not. In 2003, the Maternal and Child Health Bureau sent a letter to Officials of the Hemophilia Diagnostic and Treatment Center Regional Projects Grantee Institutions stating that, “MCHB requires the HTC grantee and their affiliate institutions to use program income to further eligible project and program objectives.” In the 2005 Hemophilia Treatment Center Manual for Participating in the Drug Pricing Program Established by Section 340B of the Public Health Service Act, the MCHB reiterated this requirement, stating:

“revenue, whether or not the HTC is a 340B covered entity, is program income and subject to the rules for that kind of income in the grant regulation and the policy statement. The rules apply to both HTC regional grantees and their affiliates.”

Additionally, the most recent Regional Hemophilia Network Funding Opportunity (Number: HRSA-22-068) states that:

“The program income must be used for the purposes and under the conditions of the federal award.” Recipients are to add program income revenue to the funds committed to the project or program to “further eligible project and program objectives.” More specifically, reportable net program income is to be used for patient health, education, and supportive services necessary to provide comprehensive care to patients with hemophilia or related clotting and bleeding disorders served by the HTCs. Any proposed use of program income must be submitted to HRSA for Prior Approval through HRSA’s Electronic Handbooks (EHBs).”

Taken together, this guidance means that HTCs can collaborate with their in-house/institution pharmacies in the provision of gene therapy to their patients. However, revenue generated from those services must still be treated as program income.

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Washington Update

HELP Copays Act Reintroduced
by Johanna Gray, Advocacy Consultant

I’m so pleased to share that the Help Ensure Lower Patient Copays Act (HELP Copays Act) has been reintroduced in the House! You may recall that this bill was first introduced in the last Congress to prohibit copay accumulator adjustor programs and close a loophole that some plans are using to say that covered drugs don’t count as essential health benefits (EHBs). In the 118th Congress, the bill number is HR 830 and it was introduced by Reps. Buddy Carter (R-GA), Nannette Barragan (D-CA), Mariannette Miller-Meeks (R-IA), Diana DeGette (D-CO), Brian Fitzpatrick (R-PA), Bonnie Watson Coleman (D-NJ) and Yvette Clarke (D-NY). The Alliance joined in a statement with the All Copays Count Coalition thanking the sponsors for their leadership in introducing the bill and will be lobbying for its passage.

Given the interest in PBM reform this year, we are hopeful that the bill will have more traction and pass this year! But we need your help! Unfortunately, I know that many Alliance members have had patients run into awful situations with copay accumulator adjustor programs and we should use those experiences to make the case for why Congress should act. If you would like to contact your Member of Congress to ask them to co-sponsor the bill, please let me know. I’d be happy to provide you with the right contact info and talking points to send the email.

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Payer Update

Call the Alliance Bat Phone!
by Jeff Blake, Senior Vice President Member & Community Relations

At one of the breakout sessions at our Member Meeting in Nashville this month, we discussed various payer issues that our members encounter. The most common issue discussed was exclusive specialty drug carve outs to commercial specialty pharmacies, which prevent HTC pharmacies from dispensing to their patients. One person recommended the Hemophilia Alliance needs a “Bat Phone” to help HTCs with these urgent issues. After the meeting I reflected on this recommendation more and determined that we DO offer this “Bat Phone” service, but we need to remind and make our members more aware how we can help.

Recently one of our member HTCs contacted us with an urgent payer issue with one of their patients. For over 10 years the patient was receiving their medication from the HTC pharmacy. The HTC became aware of an insurance change when they were going to dispense to the patient in early January. The HTC was able to receive a 1-time override from the payer to dispense in January but they were told future dispensations would need to be filled by their exclusive specialty pharmacy. The HTC contacted us to see if we could help.

The HTC provided us with the necessary data to research and try to solve the issue – employer name (we determined this was a self-insured employer plan), medication prescribed, payer name and commercial specialty pharmacy. The Alliance Team immediately went to work utilizing our payer tools and resources. Within 48 hours we were able to determine the insurance broker that works with the employer on the health plan design. Within a few days we were able to meet with the insurance broker, highlight the clinical value of the HTC integrated medical and pharmacy care model and savings the HTC pharmacy would provide to the employer. In addition, we let the insurance broker know the patient wanted to continue to use the HTC pharmacy. The insurance broker met with their client to discuss our solution and their client agreed they should continue to allow the HTC pharmacy to provide services for the remainder of 2023 through an individual Letter of Agreement (LOA) with an option to renew the LOA for 2024. This was accomplished within 30 days. THERE IS NO CHARGE FOR THIS SERVICE BEYOND YOUR ANNUAL MEMBER DUES it is on top of your 27,749 % ROI.

Are you encountering payer issues that our “Bat Phone” service may be able to help? The Hemophilia Alliance Team is an email or phone call away to help. Feel free to contact me directly – jeff@hemoalliance.org or 317-657-5913 and I can connect you with the Director of Member and Community Relations for your center. Remember: we work for you!

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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 joe@hemoalliance.org 215-439-7173
Sean Singh sean@hemoalliance.org 813-748-7226
Jeff Blake jeff@hemoalliance.org 317-657-5913
Jeff Amond amond@hemoalliance.org 608-206-3132
Jennifer Anders jennifer@hemoalliance.org 954-218-8509
Angela Blue, MBA angela@hemoalliance.org 651-308-3902
Zack Duffy zack@hemoalliance.org 503-804-2581
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Johanna Gray, MPA jgray@artemispolicygroup.com 703-304-8111
Karen Bowe-Hause karen@hemoalliance.org 717-571-0266
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Elizabeth Karan elizabeth@karanlegalgroup.com 612-202-3240
Kollet Koulianos, MBA kollet@p3hbc.com 309-397-8431
Roland P. Lamy, Jr. roland@hemoalliance.org 603-491-0853
Dr. George L. Oestreich, Pharm.D., MPA george@gloetal.com 573-230-7075
Theresa Parker theresa@hemoalliance.org 727-688-2568
Mark Plencner mark@hemoalliance.org 701-318-2910
Ellen Riker eriker@artemispolicygroup.com 202-257-6670

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