Hemo Alliance Newsletters

October 2024 Newsletter

In This Issue...

Jeff Weighs In
Administration and Operations Update

Fall Member Meeting Review
by Administration & Operations Team

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As they say in New Orleans, “Laissez les bons temps rouler” and let the good times roll we did! At the 2024 Fall Member Meeting, 120 individuals attended, representing a wide variety of HTC roles (see table), with Pharmacists, Program Managers, and Administrators as the largest groups. Using feedback from previous meetings, we worked hard to reinvigorate the agenda. The meeting evaluations were very positive (see Session Satisfaction Survey results), with one attendee summing it up perfectly, “Stacy’s presentation, Jeff’s energy, Phil’s vulnerability, Marisela’s experience, knowledge, and energy” were a big hit!

We also made time to celebrate the Hemophilia Alliance’s 25th Anniversary with some special sessions focusing on “past, present, and future” and an evening at the New Orleans Aquarium. A big part of our member meetings is networking, but as the team reflects on what 25 years of service to the bleeding disorders community means, we are grateful for the time we get to spend and learn together. Thanks to all of you who attended and for those who couldn’t, we hope to see you at the next member meeting in Spring 2025. Check out our other upcoming events here!.

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UPCOMING MEETINGS

DATE

Pharmacists CE Conference [CLICK HERE TO APPLY]

January 22 – 24, 2025 (San Diego, CA)

Linda Gammage Social Workers CE Conference [SAVE THE DATE]

February 26 – 28, 2025 (Austin, TX)

Spring Members Meeting [SAVE THE DATE]

March 9 – 11, 2025 (Location: TBD)

Nurses CE Conference [SAVE THE DATE]

April 27 – 29, 2025 (Orlando, FL)

New HTC Staff Orientation [SAVE THE DATE]

April 29 – May 1, 2025 (Orlando, FL)

Physical Therapists CE Conference [SAVE THE DATE]

May 14 – 16, 2025 (Phoenix, AZ)

Fall Members Meeting & Hill Day [SAVE THE DATE]

October 5 – 7, 2025 (Washington, DC)

 

Advocacy Update

340B Reform Legislation – Current Status and Predictions
by Artemis Policy Group

2024 has been an active year for 340B Reform legislative proposals. As of now, there are two comprehensive 340B reform proposals and several other smaller 340B transparency/reform bills. See the table below for brief summarizes the four bills that merit the most attention.

Artemis continues to be skeptical about the probability of comprehensive 340B reform occurring this year. Of the two comprehensive proposals –340B Access Act (the House bill) and the SUSTAIN 340B Act (the Senate bill) – one has few co-sponsors who are all of one party and the other is yet to be introduced, and neither are bicameral. These characteristics create significant barriers to passage of either proposal this year. It is most likely that these bills will not move forward this year but will be reintroduced in the new Congress next year.

 118th Congress Bill Details What Does Bill Do? Impact on HTCs
 IHR 4758: Accelerating Kids’ Access to Care Act; introduced 7/19/23 by Rep. Lori Trahan (D-MA); Passed the House and referred to the Senate on 9/17. Primarily a bill to expand access to care across state lines for kids in Medicaid and CHIP, but the House version was amended in July 2024 to include a provision on spread pricing in Medicaid. Covered entities can be paid more than actual acquisition cost (AAC), but they can’t be paid more than what other providers are being paid, and they must report their margins for Medicaid to HHS, which will make data public.Would apply to HTCs – transparency would be required and made public. 
 HR 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; introduced 5/15/23 by Rep. Bucshon (R-IN); passed House Energy and Commerce Committee on 5/24/23 Requires hospitals to report lots of 340B data to HHS (patients served, insurance status, costs incurred at the sites, reimbursement) that would be made public. HHS would have authority to extend to grantees. Could apply to HTCs, but it would require HHS to proactively decide to include us when implementing the law.
 HR 8574: the 340B ACCESS Act; introduced 5/28/24 by Reps. Bucshon (R-IN), Carter (R-GA), and Harshbarger (R-TN). This bill stems from ASAP 340B (which is the NACHC/PhRMA nonprofit pushing for reforms) and is one of the two comprehensive 340B reform proposals. There are some good provisions for HTCs and a number of harmful ones.
 Not yet introduced: SUSTAIN 340B Act. This is the bipartisan comprehensive reform bill that may be introduced by the Gang of 6 Senators in September. There are some good provisions for HTCs and we have been actively meeting with the staff to try to mitigate potential harmful provisions.

If any 340B reform proposals become law this year, it would most likely be as part of a larger package and resemble one of the transparency provisions in HR 3290, which was passed by the Energy and Commerce Committee or HR 4758, which passed the House. The transparency/data reporting provisions could have traction both because they could be seen as middle-ground proposals that respond to some of the biggest concerns (lack of transparency generally and oversight over hospitals in particular), but also because the spread pricing provision of HR 4758 is included as a pay-for for the other provisions of the bill. This makes HR 4758 a greater chance of moving forward.

Proposed Strategy for Remainder of 2024

Our main goals are to protect HTCs from harmful legislation this year as well as in 2025 when some of these bills will likely be introduced. To accomplish this, we plan to meet with the relatively small group of staff/Members who will be deciding what is included in an end-of-year package to share our concerns. We will alert HTCs if any grassroots contacts (emails and calls) are needed and if so, provide updated materials – fact sheets and talking points. We will also continue to collaborate with our grantee colleagues and have already begun outreach to the drug manufacturers in the bleeding disorder space, to ensure their continued support for HTCs in the 340B program.

Legal Update

340B Update – Contract Pharmacy Litigation and State Laws to Related Pharmacies and PBMs
by Issie Karan, Karan Legal Group

Since 2020, more than 38 manufacturers have announced policies to restrict access to 340B pricing for drugs ordered by a covered entity to be shipped to a contract pharmacy location for dispensing, most commonly only allowing one contract pharmacy relationship and reporting for claims data. Thus far, manufacturers have exempted HTCs from these restrictions. However, hospitals and federally qualified health centers have lost significant funding.

Because of these changes, lawsuits and new state laws have proliferated. Multiple manufacturers sued the government regarding the allowability of contract pharmacy restrictions and received favorable rulings on appeal (in the 3rd and DC Circuits) and await a decision in the Seventh Circuit. If the Circuits split, the issue could be appealed to the Supreme Court (SCOTUS).

States also have gotten into the mix with new laws responding to manufacturers’ conditions. Generally, these state laws prohibit drugmaker restrictions on contract pharmacies, require Pharmacy Benefit Managers (PBMs) to offer fair payment and network participation to covered entities, and or require reporting. Arkansas received a favorable ruling on its PBM law (8th Cir.) and has moved to enforcement. However, Oklahoma awaits the results of an appeal from the 10th Circuit’s determination that aspects of their Patient’s Right to Pharmacy Choice Act are preempted by the federal Employee Retirement Income Security Act of 1974. On May 10, 2024, Oklahoma Insurance Department filed a petition for a writ of certiorari to SCOTUS which should have an outcome on in the next month. Additionally, 31 attorneys general from 31 states filed an amicus curiae brief. As a reminder, in Rutledge (2020), SCOTUS ruled that an Arkansas law regulating PBMs’ drug reimbursement rates were not preempted by ERISA. So SCOTUS may have a strong incentive to affirm their earlier precedence on ERISA preemption.

What do HTCs need to know? PBMs continue to be at the center of public discourse regarding access to treatments and preferred pharmacies and rising drug costs, driving action by lawmakers and the courts at the state and federal level to ensure patient access. These legislative reforms could sweep up 340B reform and impact HTC operations. Please continue to remain engaged on 340B advocacy and law changes at the state and federal level and keep reading the newsletter for updates!

 

HHS Adopts Changes to the Uniform Grants Guidance
by Issie Karan, Karan Legal Group & Michael B. Glomb, Feldesman Leifer

HHS released an interim final rule for comment which proposes to repeal HHS’ existing regulations governing the administration of HHS financial assistance awards (i.e., federal grants), at 45 Part 75, as of October 1, 2025, and adopt the Office of Management and Budget’s (OMB’s) codification of the federal grant rules at 2 CFR Part 200 (with some HHS-specific policies codified at Part 300). The government characterizes this change as non-substantive.

The Hemophilia Alliance suggests that all member HTCs check-in with their in-house compliance, offices of sponsored programs, and others who oversee your participation in government grants to update them about the changes described below.

The final rule indicates that HHS will accept comments on only part of the rule, specifically, the plan and timeline for adopting the 2 CFR Part 200 & 300. HHS will not respond to comments regarding the content of Uniform Grants Guidance (UGG) as they indicate that these are not new requirements for federal grantees. Comments are due November 1, 2024. Given that HHS will only consider comments on the process for implementation, and not the substance of the UGG itself, the Alliance does not anticipate submitting comments.

Additionally, the final rule includes policies which already went into effect on October 1, 2024, mainly updating the dollar amounts that trigger an audit or different classification of an expense. The provisions already in effect include the following:

Today and increasingly over the next year, HTCs likely can anticipate seeing new references to the Uniform Grant Guidance used by the government and in grant instruments. The Hemophilia Alliance will begin to transition to the updated references. Again, we recommend that HTCs check-in with their in-house compliance, offices of sponsored programs, and others who utilize the UGG about the changes.

HTC Frequently Asked Compliance Questions: October 2024

As part of the benefits of being a member in the Hemophilia Alliance, Hemophilia Treatment Centers (HTCs) can seek advice from the legal team about compliance and understanding the many rules which govern how HTCs operate. We highlight the themes of these conversations in our newsletter articles, but we will begin to compile these questions and host them on the Alliance website. As it makes sense, we will highlight some of these FAQs in future newsletters, including the question below which came up at the Fall Members Meeting. So, stay tuned for more exciting updates!

Question: Are rebates and/or discounts included in the definition “Program Income” under the Uniform Grants Guidance?

Short Answer: Rebates do not fall under the definition of “program income” but do constitute “applicable credits” which offset or reduce expenditures under the grant, and such credits must be credited to the Federal award. Meaning, rebates and discounts should reduce costs under the Federal award, leading to a proportional increase in program income.

Long Answer: There’s No Such Thing as a Free Lunch

Hemophilia Treatment Centers (HTCs) have asked whether rebates are considered “program income” under the Uniform Grants Guidance (UGG). Although rebates are excluded from the definition of program income, rebates constitute “applicable credits” under the UGG. Meaning, HTCs must utilize rebates to offset expenses accrued because of grant activities and appropriately account for their use. Given the confusion, the Hemophilia Alliance provides relevant legal citations below.

The UGG defines “Program Income” as:

“[G]ross 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 except as provided in § 75.307(f). (See Period of performance.) Program income includes but is not limited to income from fees for services performed, the use or rental or real or personal property acquired under Federal awards, the sale of commodities or items fabricated under a Federal award, license fees and royalties on patents and copyrights, and principal and interest on loans made with Federal award funds. Interest earned on advances of Federal funds is not program income. Except as otherwise provided in Federal statutes, regulations, or the terms and conditions of the Federal award, program income does not include rebates, credits, discounts, and interest earned on any of them. 45 C.F.R. §75.2 and with similar references at 2 C.F.R. 200.1 effective for HHS grantees 10/1/25.

The text emphasized above may mislead HTCs into thinking that rebates can be treated as unrestricted funds. However, the UGG has more to say about reductions in costs under federal grant awards.

“Applicable credits refer to those receipts or reduction-of-expenditure-type transactions that offset or reduce expense items allocable to the Federal award as direct or indirect (F&A) costs. Examples of such transactions are: Purchase discounts, rebates or allowances, recoveries or indemnities on losses, insurance refunds or rebates, and adjustments of overpayments or erroneous charges. To the extent that such credits accruing to or received by the non-Federal entity relate to allowable costs, they must be credited to the Federal award either as a cost reduction or cash refund, as appropriate.42 C.F.R. §75.406(a) and with similar references at 2 C.F.R. 200.406 effective for HHS grantees 10/1/25.

We advise HTCs to seek advice from legal, accounting, and compliance experts about rebate funds. However, the Hemophilia Alliance team is also available to answer questions.

Notes From The Community

YETI Reunion at the Bleeding Disorder Conference
by Madonna McGuire-Smith, Executive Director PNWBD

On Thursday, September 12, about 75 people gathered at the Bleeding Disorders Conference in Atlanta, GA for a Youth Effectively Transitioning to Independence (YETI) reunion event. All attendees were given a chance to mark their place on a US map with a butterfly needle – such a unique opportunity enjoyed by all! The gathering was a great opportunity for people to reconnect that have attended YETI previously and for those who wanted to learn more about YETI so they can attend in the future. It was great to see HTC staff, bleeding disorder organization staff and some of our previous participants. It’s wonderful that The Hemophilia Alliance has been such a strong supporter of the YETI reunion both this year and last year!

The YETI Conference is a national event held at a camp nestled in the forest just outside of Portland, Oregon, designed to support the development of bleeding disorder-specific teen programming. This weekend-long experiential train-the-trainer program brings together Hemophilia Treatment Centers (HTCs), local bleeding disorder organizations, and community members.

The conference is divided into two tracks: a teen track and an adult track. In the adult track, HTC staff and local organization leaders experience the teen program firsthand, pausing throughout to discuss best practices for creating effective and safe programs. Meanwhile, the teen track offers participants the chance to connect with peers from across the country, explore leadership opportunities, and learn how to develop similar programs in their home states.

Throughout the weekend, both tracks come together to collaborate and learn from one another. Since 2017, YETI has trained 115 bleeding disorder entities nationwide.

YETI 2025 will be February 20 – 23. For more information please go to https://pnwbd.org/yeti/

Member and Community Relations Update

Reception for National Youth Leadership Institute (NYLI) at BDC 2024
by Karen Bowe-Hause, Director of Member & Community Relations

The Hemophilia Alliance sponsored and planned the program for the NYLI meeting at NBDF’s Bleeding Disorder Conference in August. The speakers represented a variety of clinical and non-clinical positions at HTCs. The goal was to help NYLI attendees understand that they can find engaging and rewarding careers in the health care space that are both within and outside the traditional clinical roles.

The National Youth Leadership Institute (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. NYLI is a two-year NBDF program designed to assist young people from the bleeding disorders community in becoming well-trained, recognized leaders. In addition, NYLI provides an amazing opportunity for youth to learn and share experiences of living with a bleeding disorder.

The Hemophilia Alliance would like to thank the HTC staff members who led the discussions at this session and send a special thank you to the wonderful group of young adults who shared their time with us:

  • Doris Quon, MD, PhD, Orthopaedic Hemophilia Treatment Center, Los Angeles, CA
  • Emily Bisson, APRN, CPNP-PCN, Dartmouth-Hitchcock Hemophilia and Thrombosis Center, Lebanon, NH
  • Penni Smith, RN, Utah Center for Bleeding and Clotting Disorders – Intermountain, Salt Lake City, UT
  • Jennifer Borrillo, MSW, LCSW, MBA – Senior Vice President of Member & Community Relations, Hemophilia Alliance (former Program Manager, Louisiana Center for Bleeding and Clotting Disorders – Tulane, New Orleans, LA)
  • Jennifer Anders, Manager of Data and Analytics, Hemophilia Alliance

Save the Date for the 27th Annual Linda Gammage Social Worker Conference – Feb 27 – 28, 2025
by Jeff Amond, Director of Member & Community Relations

The Hemophilia Alliance is proud to announce the 27th Annual Linda Gammage Social Worker Conference is scheduled for February 27th and 28th in Austin, Texas. This is an in-person clinical conference specifically intended for Social Workers with direct clinical responsibility in the bleeding-disorders field. This two-day event will require a commitment of arrival on Wednesday February 26th and departing after 2 pm on Friday, February 28th, 2025. Travel expenses will be paid for by the Hemophilia Alliance. The Hemophilia Alliance will underwrite each participant’s air travel, transfers to and from the hotel, conference hotel accommodations (room and tax) and the group meal expenses. Qualified applicants will be chosen from the pool of applicants*. Information about applying will be sent out at a later date.

Each day of the conference will cover different topics:

  1. Day One, Trauma Informed Care: Advocating for a Culture of Harm Reduction and Healing, will build upon prior Linda Gammage Social Work Conference Content. In this session, participants will expand concepts of trauma to a macro level of practice. A Trauma Informed Care service approach acknowledges the widespread impact of trauma and adversity on those we serve, as well as ourselves and our colleagues. This session will focus on cultivating harm reduction and healing through attention to physical and emotional safety, trust and transparency, cultural responsivity, collaboration, and mutuality. Participants will consider impacts of toxic stress and be provided with strategies to support wellness and resilience.
    • SpeakerMandy Davis, PhD, LCSW, is a Professor of Practice at Portland State University’s School of Social Work and a licensed clinical social worker. She is the Director of Trauma Informed Oregon, a program advancing trauma informed care throughout organizations and systems through training, consultation, and implementation resources. Dr. Davis teaches and lectures on implementing trauma-informed care and trauma specific services. Her current interests include measuring change when organizations and systems implement the principles of trauma informed care, the impact of toxic stress on the workforce and intersectionality between equity work, resilience, and trauma informed care.
  2. Day Two, Artificial Intelligence (AI) 101 and Beyond: Shaping AI in Social Work and Bleeding Disorders Care. AI’s integration into social work unlocks many opportunities. This session will introduce the basics of artificial intelligence (AI), machine learning, and the ethical considerations surrounding these technologies. We will learn how AI is used in various fields, including social work and healthcare, and will explore its potential benefits and risks in our work. This session will provide a practical overview of AI’s role and impact and inspire ideas on how AI can be effectively and responsibly integrated into your practice. Using collaborative tools, participants will brainstorm, deconstruct different AI perspectives, encourage ethical reflection, and collectively imagine a future where AI is shaped to meet the needs of your profession and patients.
    • Speaker Dr. Sara E. Berger is a Senior Research Scientist at IBM research, specializing in applied technology ethics. She holds a BA in neuroscience from Macalester College and a PhD in systems and cognitive neuroscience from Northwestern University, with an emphasis in bioethics. With over 15 years of experience in pain neuroscience, she has explored psychological, neurological, and social aspects of pain perception and treatment, leveraging machine learning and AI to develop better neuromodulatory systems and measurements for pain. In 2021, MIT Tech Review named her a Visionary in its 35 Innovators Under 35 for Applying AI to improve pain care. Currently, she develops frameworks, methods, and tools to address ethical, legal, and societal issues in data and technology, including AI and neurotechnologies.

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
Jeff Blake jeff@hemoalliance.org 317-657-5913
Jennifer Borrillo, MSW, LCSW, MBA borrillo@hemoalliance.org 504-376-5282
Heidi Lane, PT, DPT, PCS heidi@hemoalliance.org 435-659-1230
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
Karen Bowe-Hause karen@hemoalliance.org 717-571-0266
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
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Elizabeth Karan elizabeth@karanlegalgroup.com 612-202-3240
Kollet Koulianos, MBA kollet@hemoalliance.org 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