In this Issue…

Notes from Joe

Legal Update
· Genesis Healthcare Inc. v. Becerra: District Court Invalidates HRSA’s Patient Definition and Implementation in 340B Program

Advocacy Update
· 2025 NBPP Proposed Rule Released with Positive Policies for Bleeding Disorders Community

Member and Community Relations Update
· From Frustration to Opportunity – Maximizing HANS as a Resource

Alliance Update
· Hemophilia Alliance Resources Available to Members
· 2024 Meeting Schedules

Notes from the Community
· 2023 Unite Walk Wall of Walkers update

Team Alliance Contact Information

by Joe Pugliese, President and CEO

“The single biggest problem in communication is the illusion that it has taken place.”
George Bernard Shaw

The Alliance just completed a very successful Physician /Administrator meeting in CA. The program was well attended, with 31 business administrators and 27 physicians. The sessions were led by Alliance staff, Alliance board members and attendees. Participants enjoyed interactive informational sessions, lots of networking, and even some fun – a trivia night and a cooking class that allowed everyone to show different sides of their personalities – as well as a 3-hour certified program from Cornell University. This conference was the first of its kind effort. We are surveying the attendees and using their responses to fine tune next year’s meeting.

We talked about a host of topics; I think the best received sessions were the interactive sessions, which allowed participants to discuss topics at their tables and report out their findings. I want to highlight one of our discussions about strategic communications with patients and families.

I had been looped into a concern of a dissatisfied mother of two boys aired on social media. As you know we live in an age where social media seemingly distorts everything in under 60 seconds. The mom was complaining about her HTC and said that suddenly the doctors were demanding visits every six months and were withholding prescriptions in the meantime. Other voices on the social media thread weighed in with their own horror stories about their physicians not listening to them.

I gave the participants at the Physician/Administrator meeting the assignment of developing a strategic approach to handling these types of scenarios – both dealing with complaints from patients and responding to hubbubs on social media more generally. The assignment generated a great deal of discussion. One group formed a debate team with one side taking the position of patient/parent and the other the provider. Another group wrote out their protocol for seeing patients and others detailed the scenarios when they would want to see a patient more frequently than once per year and how they communicate that preference/expectation to their patients.

Following the meeting, I reached out to the center that was the subject of this social media thread. It was rewarding to me that their response was immediate. They did not have protocol on why a patient should be seen more frequently than annually, and they wanted to address the mother’s concerns. It seems the news regarding the prescriptions did not come from the treatment center, but rather from a third-party pharmacy. In fairness to all parties, it is not clear when or how that communication went off track.

My goal here is not to point fingers, but rather to raise awareness for HTC providers and their patients and caregivers. Having a clearly spelled out protocol for writing prescriptions, and scheduling visits, helps everyone have the same expectations. More importantly, having clear and honest communications between everyone can help to address concerns before they make it to social media.

I encourage patients and families to feel at ease asking their HTC care team any questions. And healthcare providers, I encourage you to present yourself in a way that says it is okay to ask.

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Genesis Healthcare Inc. v. Becerra: District Court Invalidates HRSA’s Patient Definition and Implementation in 340B Program
by Elizabeth “Issie” Karan, Karan Legal Group, Hemophilia Alliance Legal Counsel

On November 3, 2023, the US District Court for the District of South Carolina Florence Division ruled in favor of Genesis Healthcare Inc., a federally qualified health center and covered entity in the 340B Program. Genesis challenged the government’s interpretation of the 340B Program’s patient definition. Stakeholders collectively exhaled (and some outright exclaimed) after anxiously watching the case wind through the courts in recent years.

Genesis Healthcare Inc. v. Becerra, stems from a dispute over removal of Genesis from the 340B Program by HRSA following an on-site audit conducted in June 2017. HRSA issued two findings: 1) that Genesis failed to comply with the statutory requirement of maintaining auditable records; and 2) that Genesis dispensed 340B drugs to ineligible individuals, causing diversion. HRSA issued the diversion finding because prescriptions were included in Genesis’ 340B Program that were written by providers at private clinics for patients that were later referred to Genesis, after the prescription was written. However, within a week of Genesis filing its lawsuit challenging the diversion finding, the parties reached an agreement whereby HRSA permitted Genesis to be provisionally readmitted to the 340B program.

Despite reinstatement in the 340B Program, Genesis Healthcare filed an amended complaint, contending that the case should not be dismissed because it still must follow unlawful guidance. The Fourth Circuit Court of Appeals agreed with Genesis, overruling the lower court decision, and sending the case back for a determination on its merits.

In the most recent ruling in the case, the court again sided with Genesis, stating that while the statute requires a covered entity to have an ongoing relationship with a patient in order to use 340B drugs, the government cannot further limit the use of 340B only to drugs that pertain to care that the covered entity initiated.

“If there is a desire to restrict the 340B Program and limit the ability of ‘covered entities’ to remain profitable in the face of prescription drug price increases, Congress is the appropriate entity to take the necessary action. It is not the role of HRSA to legislate and limit the 340B program by restricting the definition of the term ‘patient,’ thereby frustrating the ability of the 340B statute to accomplish its purpose.”

So, what does the outcome of this case mean for HTCs? First, we do not recommend making any changes to the operations of your 340B Program because of this opinion. The court’s decision is only binding on Genesis. Additionally, the government may either appeal the case or issue new guidance on the 340B patient definition. As such, we believe it’s too soon for acting based on the case.

Second, the court’s decision could embolden other covered entities to include referral prescriptions more aggressively in their 340B Program. The court’s decision puts the long-standing policy on the 340B patient definition in flux. More explicitly, other covered entities may want to include HTC patients in their 340B Program. While most clinics do not have the expertise to manage bleeding and clotting disorder treatments, this threat is more possible with the loosening of the patient definition. So please closely monitor how your patients (and their prescribed treatments) qualify for inclusion in your 340B Program and any interactions with other 340B covered entities prescribing for them.

Finally, the decision increases uncertainty in the 340B Program and, as the quote above highlights, sets up more arguments for congressional action on 340B. Given the packed congressional calendar for the remainder of this year, Congress is unlikely to act on 340B in 2023. However, we anticipate the case could be used to increase urgency for legislation on the 340B Program next year.

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2025 NBPP Proposed Rule Released with Positive Policies for Bleeding Disorders Community
by Johanna Gray, Artemis Policy Group, Hemophilia Alliance Advocacy Consultant

On November 15, the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) released the Notice of Benefit and Payment Parameters (NBPP) proposed rule for the 2025 plan year. The NBPP set rules and regulations for plans on the federally run Marketplaces and for other private insurance plans subject to the Affordable Care Act’s provisions.

The proposed rule includes a few provisions that, if finalized, would strengthen the rules and make them better for people with bleeding disorders:

First, there is a provision which clarifies that covered prescription drugs not included in a State’s essential health benefit (EHB) benchmark plan are still considered essential health benefits (EHBs) and therefore, they are subject to requirements including the annual limitation on cost sharing and the restriction on annual and lifetime dollar limits. While this does not address copay accumulator adjustor programs (CAAPs), it does clarify, in federal regulation, that any prescription drug covered by a plan must be considered an EHB and therefore, some copay maximizer programs would not be allowed. We are still waiting on additional guidance from HHS regarding the September ruling on CAAPs, but this provision is another positive step forward in the fight against deceptive insurance practices.

Second, there is a provision in the rule suggesting that HHS is going to change the way they define which drugs must be covered by plans – moving from a list that primarily focuses on drugs covered under Medicare Part D to one that is broader. We have encouraged them to make this change so that it is clearer what Medicare Part B drugs plans must cover, like clotting factor and other bleeding disorders treatments. This new grouping is called the USP DC. Separately, the Alliance worked with NBDF and HFA to advocate to the organization that creates the USP DC that they should separate bleeding disorders treatments into multiple categories and classes to ensure that plans aren’t able to cover, only one hemophilia B treatment and say that is sufficient for all people with bleeding disorders in their plans.

Both provisions are positive signs, though we know that more work is necessary. The Alliance will continue to work with the patient organizations to support these policies and make additional recommendations for HHS to ensure that people with bleeding disorders have access to care.

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From Frustration to Opportunity – Maximizing HANS as a Resource
by Jeff Amond, Director Member & Community Relations

Over the last few weeks, I attended two Regional Meetings. One big take home message from many of the attendees was the continued frustration of losing HTC pharmacy patients to commercial specialty pharmacies. As we know, this frustration has been going on for many years. In 2018, I wrote a newsletter article about the frustration I personally had when I worked at my old HTC because I just didn’t have the time nor the resources to take on that fight of trying to get the lost patients back to our pharmacy program. In 2020, I wrote another newsletter article about HTCs that were feeling overwhelmed and frustrated with the struggles to keep their patients under their pharmacy program.

In 2023 the frustration continues, but we are better able to combat the problem through new opportunities made available by the Hemophilia Alliance Network Services (HANS). Below is a summary of the results of bringing business back to HTC pharmacy programs since 2018, along with the potential new units from our current opportunities. We have brought back over 45,000,000 units to our member HTC pharmacies over the last five (5) years and our member HTCs have been able to retain these units in their pharmacy programs.

These results are an example of our success, but we can do so much more with your help and participation in our HANS PPO network. New opportunities present weekly/monthly to bring patients back to your HTC for clotting factor dispensations. HANS participation facilitates quick turnaround of these opportunities to ensure we do not lose patients. Importantly, HANS is closing in on formal agreements for inclusion of Gene Therapy products with several major entities that will pave the way for your HTC to be paid for these high-cost products when you are ready to provide them to your patients. The conversations the HANS Team has with insurers about Gene Therapy have also opened new doors for participation in networks for traditional clotting factor where HTCs have historically had difficulty dispensing products to patients within their care.

If you have been waiting for a reason to join HANS, now is a great time to start that process. Discussions with insurers and employers on Gene Therapy solutions and traditional products are increasing rapidly. The Hemophilia Alliance team would like you to be prepared to take advantage of these new opportunities as they emerge. Let us help with your insurance issues, let us help you in retaining your current pharmacy patients, let us help you with Gene Therapy solutions and agreements, and let us help you win back the clotting factor business to your HTC. WE WORK FOR YOU!

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• Hemophilia Alliance Resources Available to Members

by Marketing & Operations Team

Over the past few months, we’ve been actively engaged in knowledge-sharing and collaboration through a series of webinars and two member meetings. These events served as valuable platforms for our members to stay tuned in to industry trends, share insights, and network with their peers. We want to let you know that all the materials from these sessions, including presentation slides, documents, and relevant resources, are now readily available on our website. We encourage all members to explore these valuable resources, leveraging the wealth of knowledge exchanged during our webinars and member meetings to enhance their professional development and contribute to the collective success of our community.

Check out our 2024 meeting schedule for upcoming meetings. We hope to see you there!

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• 2024 Meeting Schedules

MEETING	DATE
Board Retreat	January 7 – 9, 2024
Pharmacist CE Conference	January 24 – 26, 2024
Linda Gammage Social Worker CE Conference	February 28 – March 1, 2024
New HTC Staff Orientation [REGISTER NOW]	March 25 – 27, 2024
Spring Members Meeting and Hill Day [REGISTER NOW]	April 15 – 18, 2024
Nurses CE Conference	June 10 – 12, 2024
Physical Therapist CE Conference	August 12 – 14, 2024
Fall Members Meeting	October 9 – 11, 2024
Physicians and Business Administrators Meeting	November 13 – 17, 2024

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2023 Unite Walk Wall of Walkers update
by Karen Bowe-Hause, Director Member and Community Relations

In collaboration with the National Bleeding Disorders Foundation, the Hemophilia Alliance was proud to sponsor the 3rd annual Unite Walk Wall of Walkers campaign, designed with the intent to inspire further partnerships between our member Hemophilia Treatment Centers & their local Chapter affiliates. This year, the Walk saw a 5% increase in HTC participation with a 24% increase in HTC participants walking and an overall 14% increase in money raised to support local Chapters and the bleeding disorders community. The Alliance would like to congratulate the 2023 Wall of Walkers Top 5 Hemophilia Treatment Center teams who have earned top fundraising status for the Unite for Bleeding Disorders Walk in their assigned market! Collectively, the 37 member HTC teams organized raised more than $37,000 to support their local Chapters through this initiative in 2023. Each of the 5 top HTC teams will receive a $1,000 scholarship that is intended to be used to send a staff member to the 2024 NBDF Bleeding Disorders Conference that will be held September 12th – 14th in Atlanta, GA. The 5 winning teams are:

1. HTC – Smells like HEME Spirit (Team Captain – Emily Mahrt) – Oregon Health and Science University Hemophilia Center, in support of the Pacific Northwest Bleeding Disorder Foundation
2. UC San Diego HTTC (Team Captain – Frida Cortez) – UC San Diego Health, in support of Hemophilia Association of San Diego County
3. Ortho Walkers (Team Captain – Doris Quon) – Orthopedic Institute for Children Hemophilia Program, in support of the Hemophilia Foundation of Southern California
4. Chill Factor (Team Captain – Desiree Hill) – University of Colorado, Hemophilia and Thrombosis Center, in support of Colorado Chapter, National Bleeding Disorder Foundation
5. Team Hemophilia Treatment Center (Team Captain – Julie Doyle) – Cincinnati Children’s Hospital, in support of Tri-State Bleeding Disorder Foundation

The Hemophilia Alliance would like to thank ALL our member HTC teams for supporting the community, the local Chapters and NBDF in one of the largest fundraising events for NBDF and Chapters across the country!!

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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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