In this Issue…

Notes from Joe
· Final Edition

Advocacy and Legal Update
· Future of Copay Accumulator Adjustor Programs Remain Up in the Air
· Proposed Rule on Affordable Care Act Provisions Published

Member and Community Relations Update
· Medicare Part B Update – Modifiers Required on All Medicare Part B Claims Starting January 1, 2024
· Recap of Payer Activity

Alliance Update
· 2023 Alliance Meetings Create Forums for Education, Collaboration and Fun
· 2024 Meeting Schedules

Notes from the Community
· Announcing Project and Patient Assistance Grants for 2024!

Team Alliance Contact Information

Final Edition
by Joe Pugliese, President and CEO

Dear Bleeding Disorders Community,

It has been, my wife, Karen and my privilege and pleasure to be part of this community since 1977. It is beyond remarkable how much this community has endured, evolved, and grown over this time. Since this is my final notes from Joe, I will do a brief review of what the Hemophilia Alliance has achieved under my watch, but I remind you there are hundreds of people who made all of this possible.

The story started with my serendipitous introduction to this community in 1977 when I went to work for Armour Pharmaceutical. It was there through a series of career moves and even more changes in ownership that I was able to come to really know every corner of this community. Naturally that started with the patients and the clinicians who manage their care. While I worked for the company, Monoclate, Mononine, Humate-P, and Stimate were brought to the market. Since 2004, Armour became known as CSL Behring and its commitment to innovation did not end with my departure. Idelvion and Hemgenix are the most obvious examples of that continuing commitment.

During my 27 years with Armour/RPR/Centeon/Aventis Behring, the company funded many innovative approaches for reaching people with hemophilia, supporting patient education programs, like Raising a Child with Hemophilia, spearheaded by Laurie Kelley who unlike today, was unknown to the hemophilia community. We also funded Renne Paper’s book on living with von Willebrand disease and initiated Getting in the Game and the Linda Gammage Social Workers conference, both are enduring programs. My thanks to all the people I worked with who empowered us to think about innovative ways to serve the community. I sorely miss all the wonderful people I worked with, many of whom are still on the job.

I think all of those experiences uniquely qualified me to lead the Hemophilia Alliance starting in 2006 and building it into the organization it is today. It also took the tremendous support I received from the founding Board of Directors, the Board members who followed and all my colleagues at the Alliance. Particular thanks go to Amy Shapiro, Trish Dominic, and Bill Sparrow, all of whom built incredibly successful organizations of their own and were instrumental in helping the Hemophilia Alliance get started, always the hardest part of any new venture.

I would like to highlight some of the Alliance’s biggest accomplishments.

• In 2023, we have 105 participating members. We started with just one.
• The Alliance team includes 11 full-time employees and 7 contractors, who have over 300 years of experience in the bleeding disorders community and as I like to say, “box well above their weight.” If you need assistance think of them first.
• We created the independent but closely aligned, The Alliance Pharmacy (TAP), in 2010. TAP today provides critical distribution and pharmacy services to numerous members of the Alliance and like the Alliance, invests back into the community.
• The Hemophilia Alliance Foundation was created in 2013. The Foundation provides critical funding to chapters, regions and HTCs across the country providing funding.
• We funded the development of DDAVP NS in 2020 to meet a critical unmet need.
• Most recently we have funded critical education and training programs developed by our sister organizations, live NBDF’s MASAC meetings, HFA’s Mild Matter, and the Partners Physician Academy to name a few.
• We will be announcing a brand-new initiative in 2024 to help in screening and diagnosing patients in a timely manner.
• Through 2023, the Hemophilia Alliance and its foundation have given back to the community in excess of $25,000,000. We have made good on our promise to give back to the community.

There is still much to be done. I am confident that the Alliance, with my colleague Jeff Blake at the helm, will continue to grow and innovate. I won’t say goodbye. I will close the way I opened this letter; it has been a pleasure and a privilege. I wish you all a Merry Christmas and a Happy, Healthy, and Prosperous 2024 and beyond.

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• Future of Copay Accumulator Adjustor Programs Remain Up in the Air

by Ellen Riker & Johanna Gray, Artemis Policy Group, Hemophilia Alliance Advocacy Consultants

In October, the Alliance Newsletter included an article on the United States District Court for the District of Columbia ruling that insurers can no longer implement copay accumulator adjustor programs (CAAPs) for drugs that lack generic equivalents. CAAPs essentially disallow copay assistance from counting towards a person’s out-of-pocket maximum or deductible, increasing patients’ costs. We recognized the court ruling as a significant positive step forward, we stated that additional guidance from the Biden Administration was needed for implementation and enforcement of the policy.

Unfortunately, we have two signs that the Biden Administration may not be moving quickly towards implementing a favorable new policy. First, they filed a motion with the court seeking confirmation of their interpretation that they did not have to retroactively implement a ban on CAAPs before they do new rulemaking. They also filed a notice to appeal the initial decision, but it’s not clear whether they intend to really appeal the decision or if they are keeping their options open depending on what the Court says in response to their clarification motion. In any event, the Administration is yet to publish a new regulation and we are still unsure of what that rulemaking will say.

The Alliance along with a coalition of organizations that advocate against the practice of CAAPs reached out to Congress to weigh in. Forty-eight Members of Congress signed a letter to HHS asking that it drop its appeal of the decision that struck down the rule on accumulators. The letter, led by Reps Buddy Carter (R-GA) and Nanette Diaz Barragan (D-CA), reflects the bipartisan co-signers disappointment in the HHS decision and states, “We believe this decision is an important step in the right direction for patients who rely on manufacturer copay assistance to alleviate affordability and access challenges for their medicines.” There is also a Senate version of the letter, led by Senators Kaine and Marshall that will be finalized and sent next week.

The Alliance will continue its work to seek passage of the Help Ensure Lower Patient (HELP) Copays Act (H.R. 830/S. 1375). In addition to banning the practice of CAAPs, this legislation would address copay maximizers (or the “EHB Loophole”), another practice by insurers that results in patients paying more for their vital treatments by carving them out of the essential health benefits (EHB).

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• Proposed Rule on Affordable Care Act Provisions Published

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. The Alliance, along with the bleeding disorders patient organizations have encouraged HHS 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. The proposed rule refers to this new grouping as 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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• Medicare Part B Update – Modifiers Required on All Medicare Part B Claims Starting January 1, 2024

by Ellen Riker, Artemis Policy Group, Hemophilia Alliance Advocacy Consultant

As of January 1, 2024, CMS is requiring that all Medicare Part B claims submitted by HTCs for separately payable drugs purchased using the 340B Drug Discount Program include the “JG” modifier. All HTCs should update their billing systems to ensure that this modifier is included on their Medicare claims.

This requirement was included in the Inflation Reduction Act of 2022 (IRA), which established a Part B inflation rebate for drug manufacturers if their prices increased faster than the rate of inflation. The modifiers enable CMS to identify claims for 340B drugs, which are excluded from the calculation of the rebates.

Since 2018, the “TB” modifier has been required for Medicare Part B claims submitted by hospitals using 340B drugs under the Hospital Outpatient Prospective Payment System, but the requirement for non-hospital entities participating in 340B is new as of the start of the new year. CMS has provided two resources that HTCs will find useful:

• Medicare Learning Network Fact Sheet –
  https://www.cms.gov/files/document/mln4800856-medicare-part-b-inflation-rebate-guidance-use-340b-modifier.pdf
• FAQ document – https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/billing-340b-modifiers-under-hospital-opps.pdf

Contact Zack Duffy (zack@hemoalliance.org), Director, Member & Community Relations, if you have any questions about this new requirement.

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• Recap of Payer Activity

by Jeff Blake, Senior Vice President Member & Community Relations

2023 was another busy year for the Payer Team. We changed our name from the Payer Relations Team to Member and Community Relations Team (MCRs) and added two new staff members and one consultant. Our focus this year was to increase the number of HTC members that participate in our Hemophilia Alliance Network Services (HANS) PPO Network and enhance our relationships with the payer community. We now have 45 HTCs participating in our network and we have 14 in the pipeline at various stages of approval. Payers and our members are continuing to find value in HANS. Payer interest in Gene Therapy has led to HANS opportunities that also include factor units.

We developed and implemented HANS marketing material for payers and HTCs and we are enhancing our website with additional HANS information and material.

With 3.7 million units added this year, the MCR Team returned a total of 45.7 million bleeding disorder product units back to the HTC pharmacy programs since 2018. We want to continue to work with our members to significantly increase this number over the next few years. We are currently working on payer opportunities for our members that account for more than 88.5 million units.

We continue to work with State Medicaid Agencies and private payers to cover DDAVP intranasal spray and have had recent success with Nebraska Medicaid now covering the drug. Increasingly, we’ve been helping our members navigate access to care issues including Copay Accumulators, Copay Maximizers and Alternative Funding Models.

Thank you for your support in our Payer efforts! We look forward to working with you to make 2024 an even more successful year and working together to grow and strengthen your pharmacy programs.

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• 2023 Alliance Meetings Create Forums for Education, Collaboration and Fun

by Marketing & Operations Team

The Hemophilia Alliance has successfully organized seven in-person meetings throughout the year, providing an essential platform for its members to come together, collaborate, and share invaluable insights within the hemophilia community.

We started off 2023 with the Pharmacist Meeting in January. We had 38 registrants which maxed out our in-person option, but we were able to offer the CE credits through a virtual platform. The Linda Gammage Social Worker Conference followed, where we celebrated their 25th Anniversary in San Francisco, CA. Both of these meetings allowed attendees to network with their peers, learn about innovations to their focus and gain CE credits at no cost to them.




The Spring Members meeting was held in Nashville, TN in February, and was as motivating as ever. Our group dinner took us to Broadway where we were treated to a private concert by one of our very own members! In May we hosted the New HTC Staff meeting in NYC. This meeting brought together 65 newly hired employees of HTCs (the average tenure was less than six months), providing information on the ways in which the Alliance can offer support to them in their HTC roles.

Our Hemophilia Alliance Hill Day took place in June this year. Although it was later in the year than we normally go to the Hill it was still impactful for all the HTC employees, patients and Hemophilia Alliance staff and consultants that came out to tell their stories.

The St. Anthony hotel in San Antonio was the backdrop for our Fall Members meeting. Post covid, this was the best attended meeting. Our networking reception was held outside on the rooftop where the weather was “absolutely perfect”. A highlight presentation was by Jameson Buxton and Andrea Miller who spoke about what they did to become the first Gene Therapy infusion center. And who can forget Louise Baca mentioning each of the squares on the Bingo cards to make sure someone claimed “Bingo” during her presentation! The group dinner at the Texas Ranger Museum allowed for a lot of laughs amongst the displays as well as in the shooting gallery.

Finally, our inaugural Physician and Business Administrator meeting took place in Redondo Beach, CA. In addition to the presentations, strategic plan & SWOT analysis workshops, the networking sessions extended past breaks and meals and took us to trivia night and a cooking class.

All of these meetings gave us tremendous opportunities to learn how to serve the community better. Our membership continues to ask us for more networking opportunities and more up to date information on advocacy, payer, marketing, operations, and legal issues. HTCS rely on the Alliance to fully understand and seek insights into running an HTC pharmacy. We have worked to build the library on our website which has extensive and up to date videos as well as power point presentations that are downloadable for your convenience.

We hope to see more of our members this coming year at our many scheduled meetings and we welcome comments and suggestions for future meetings, locations, and presentations that YOU want to see.

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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
Physical Therapist CE Conference	May 15 – 17, 2024 (tentative)
Nurses CE Conference	June 10 – 12, 2024 (tentative)
Fall Members Meeting	October 9 – 11, 2024
Physicians and Business Administrators Meeting	November 13 – 17, 2024

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Announcing Project and Patient Assistance Grants for 2024!

We are excited to announce that applications are now available on-line for the Hemophilia Alliance Foundation 2024 Project and Patient Assistance Grants. Since 2009, the Alliance Foundation has awarded grants to help 140+ chapters, treatment centers, and national community organizations serving persons with heritable bleeding and thrombotic disorders. The cycle of funding currently available is for the following two types of grants:

• Project grants which are meant to enable eligible organizations to build on their capacity to achieve and expand their mission.
• Patient assistance grants which are meant to render direct patient/family financial assistance through eligible organizations to alleviate financial hardship as a result of, or which impacts on, the management of a bleeding or thrombotic disorder.

To be eligible the applicant organization must serve persons with heritable bleeding and thrombotic disorders and operate under IRS tax exemption 501(c)(3), 170(c)(1), or other nonprofit status. The deadline for application submission is January 31, 2024, and must be submitted directly on the Hemophilia Alliance Foundation website.

For 2024, the ceiling for grant applications is as follows:

• Local applicants (e.g., chapters/member organizations, HTCs): $8,000
• National organizations, and the eight HHS-designated federally funded regional core coordinating centers: $10,000

Applications for project grants should demonstrate clear, measurable outcomes and a strong commitment to the heritable bleeding and thrombotic disorders community. The patient assistance grant application is shorter but requires submission of the organization’s patient assistance policy.
Organizations interested in submitting applications should review the 2024 Grant Guidance thoroughly before finalizing their applications. See our website at https://hemophiliaalliancefoundation.org or use the QR Code below for more information and apply on-line today!

If your organization–or an organization you know–is interested in applying but feels like it does not have the capacity or expertise to do so, please reach out to Michael Craciunoiu, HAF Chair, at chair@hemophiliaalliancefoundation.org! We can direct you to additional resources that will help you submit a strong application.

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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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