In this Issue…

Notes from Joe
· Looking Back, Planning Ahead

Legal Update
· Update and Year in Review

Washington Update
· Year in Review

Payer Update
· Year in Review

Alliance Update
· Operations Update
· 2021 Meeting Schedule

Team Alliance Contact Information

Looking Back, Planning Ahead
By Joe Pugliese

As is typical in our December Newsletter, most of this issue will be focused on looking back over the past year and planning ahead for 2021. But before we dive deeper into all we’ve been through and accomplished this year, I want to give a very exciting breaking news highlight for the community. What makes this particularly nice is it was a community effort. Led by Johanna Gray and Ellen Riker, HTCs, local and national patient organizations and our manufacturing partners coalesced around this single critical issue for Medicare patients in the bleeding disorders, who needed rehabilitation after surgery or injury.

Congress Enacts the Hemophilia SNF Access Act: Congress included the provisions of the Hemophilia SNF Access Act in HR 133, the Consolidated Appropriations Act of 2021, which means that starting on October 1, 2021, skilled nursing facilities will be able to bill separately for bleeding disorders treatments provided to Medicare beneficiaries. Congress passed the bill late on December 21st and it now goes to President Trump for his signature over the next week. This has been a long-time advocacy goal for the community, and we are thrilled that the bill was enacted this year!

Now, to our regular year in review….

2020 is finally coming to an end, although I am afraid that the hangover is going to be nasty and prolonged. The first vaccines are now shipped and being administered, and I hope that more vaccines and more doses get to the market in short order. It was a year we would like to forget and never will. We give thanks to for all the essential workers, healthcare providers, policemen, firemen, garbagemen, trucker, retail employees, our military, postal workers, UPS, FedEx, and anyone else I missed. They have all performed heroically during the craziest year ever. Our manufacturing partners performed basically flawlessly, our early concerns in March about potential product shortages never materialized.

Closer to home, 2020 was also the year that gene therapy for hemophilia was going to be a reality, then wasn’t or at least not yet. Just this week, UniQure announced that the FDA has placed a clinical hold on its HOPE-B hemophilia gene therapy trial due to a patient enrolled in the trial being suspected of developing liver cancer. They are beginning an investigation into whether the patient does in fact have cancer, and if he does, whether it is related to receiving the treatment. You can learn more in their press release, in the recording of a call they held on the issue on December 21, 2020, and on a new website they have created to answer questions. The good news is that gene therapy will eventually get here, and, in the meantime, we have many excellent therapies available that are increasingly effective and more convenient to use.

On a brighter note, HTCs reimagined what outstanding clinical care looks like in a pandemic and beyond as we zoomed into the world of telemedicine (thank you, Roshni, for sharing your insights on one of our first weekly webinars!). While nothing will soon take the place of hands-on clinical care, virtual everything is not going away ever.

I am also proud that the Alliance Pharmacy never missed a beat in supply life-saving products to centers across the country. The Alliance suspended all business travel on March 12th. We have the benefit of being a virtual organization by design. We quickly set up weekly webinars and weekly team meetings aimed at keeping us and our members connected and informed. Like so many others, we pivoted to virtual and held member meetings and even hosted a very successful virtual Hill Day.

The promise we made to the community years ago to reinvest back into the community was also very apparent. The Alliance Board approved $500,000 in emergency patient assistance funding in March when we saw many of our community members were going to need a hand up to cope with the economic crises. The Board then approved an additional $500,000 in funding for a matching grant program with NHF focused on helping the local chapters weather the crisis.

After decades of traveling across the country and around the world, I suddenly found myself home. I find I do not miss the schlep to the airport, nor do I miss boarding the plane, countless Ubers and too many hotel rooms. I do miss the personal contact with colleagues and friends. There are people I have seen once or twice a year forever. It is those connections that make this community so special and unique; the silver lining of chronic disease.

We are looking forward to being back on the road as soon as it is safe – hopefully, next year, though it may be too early to tell. A good rule of thumb is to hope for the best and plan for the worst. Regardless, our focus for 2021 is to make sure that Alliance members have the resources and the community support you need to care for patients in the bleeding disorders community. We wish you good health and a prosperous and safe 2021.

Legal Updates and Year in Review
By Elizabeth "Issie" Karan 

340B Program ADR Final Regulation

In recent weeks, the Trump Administration released a long-awaited final regulation on the Alternative Dispute Resolution (ADR) process in the 340B Drug Discount Program (340B Program). The final rule is effective January 13, 2021. Under the new rule, ADR is limited to disputes between covered entities and manufacturers involving claims of $25,000 or higher. The dispute resolution board would consist of at least six members appointed by the HHS Secretary with equal numbers from the HHS’ Health Resources and Service Administration, the Centers for Medicare & Medicaid Services, and the HHS Office of the General Counsel. The HRSA administrator would then select and convene three-member panels made up from board members. The panels would include one member from HRSA, CMS, and OGC “with relevant expertise to review claims and make final agency decisions,” the rule said. Panel members would be screened for potential conflicts of interest, including financial interests, having family or a close relation involved in a dispute, or having a current or former business associate as an involved party. In the event of a conflict of interest, panel members can be removed and replaced by another member from the dispute resolution board.

The Trump Administration likely finalized the ADR final regulation in part to try to circumvent claims in a lawsuit brought earlier this year by the community health centers related to delay in implementation of the ADR final regulation since its inclusion in the Affordable Care Act in 2010. The impact of the ADR regulation on that litigation remains to be seen. However, the Alliance will continue to monitor the implementation of the ADR process in 340B and related litigation.

2020 in Review – Legal Team
2020 brought renewed attention to the 340B Program. Over the summer, manufacturers developed new policies towards contract pharmacies, attempting to restrict their use in 340B by covered entities. HTCs have been exempted from these policy changes to date, however, the Alliance has watched developments closely to ensure continued access to therapies for bleeding and clotting disorder patients. Covered entities have filed lawsuits – two against the government and one against manufacturers – opposing the changes to contract pharmacies in the 340B Program. Additionally, President-Elect Biden’s first choice for Secretary of the Department of Health & Human Services, current California Attorney General Xavier Becerra, joined with other AGs in publicly calling for urging the government to “accountable drug manufacturers that are unlawfully refusing to provide discounts to federally qualified health centers, hospitals, and other providers that serve vulnerable patient populations through the 340B Drug Pricing Program.”

2020 also brought unexpected changes to the financial situations of many health care organizations which, in turn, increased the volume of questions related to appropriate expenditures of program income, including charges from host institutions for indirect costs. We assisted member HTCs in compliantly supporting patients during an unprecedented time. We expect this trend to continue and will focus member education activities accordingly.

Washington Update
By Johanna Gray and Ellen Riker

We had an active year in Washington, working to advocate on behalf of HTCs and the broader bleeding disorders community, and doing our best to translate everything happening here for the community. As we look back, here are a few highlights:

• Introduction and Passage of the Hemophilia SNF Access Act: After years of research and analysis, attempted regulatory approaches, and gentle and firm advocacy from HTC social workers, nurses and physicians urging us to continue to search for a solution to this problem, we were so pleased that the Hemophilia SNF Access Act was introduced in both the House and Senate with bipartisan original cosponsors this year! And as Joe noted above, we’re thrilled that the bill was included in the omnibus federal spending bill released on December 21, 2020. That we were able to go from introduction to enactment in just one year is a testament to the effective advocacy done by so many community members.
   
• Alliance Virtual Hill Day: Our 2020 Hill Day was unprecedented in two ways: first, it was our first-ever virtual Hill Day, where we scheduled virtual meetings with Members of Congress and their staffs over zoom vs. our regular in-person meetings. Second, it was the first where Alliance members advocated for legislation (the SNF bill mentioned above) rather than just educating policy makers about HTCs and 340B more generally. We were thrilled with how everything turned out and that we had so many members who were willing to lobby for the SNF bill as well as who were especially flexible as we all adjusted to the virtual format. We expect to hold another Virtual Hill Day in 2021 and hope that you will consider joining us! In a way, it is easier than coming to DC, since you only have to set aside a few hours for trainings and meetings, rather than a few days.
   
• COVID-19 Public Health Emergency: As soon as the COVID-19 public health emergency (PHE) began in March, policymakers in Congress and throughout the federal government worked to respond. The DC team provided updates about policy changes affecting HTCs on multiple Alliance webinars, including the COVID legislative and regulatory packages, and the expansion of telehealth services in Medicare and Medicaid, allowing for services be offered to patients in their homes. We also advocated with HRSA to allow for HTCs to have flexibility in adding contract pharmacy partners if necessary due to the pandemic and sent comment letters to CMS on relevant policies.
   
• Regulatory Policy: Besides the COVID-19 related policy changes, we also worked to understand and influence other regulations. For example, President Trump released many executive orders (EOs) and proposed and final rules related to drug pricing. We analyzed all of these, identified where they might impact HTCs and drafted comment letters when necessary. We anticipate that President-elect Biden will release his own EOs and regulations after he takes office in January, and we will continue to advise the Alliance on these agency and regulatory activities. Look for updates in the Newsletter next year!
   
• 340B Program: As Issie noted above, after a quiet start to 2020 in terms of policies affecting the 340B Program itself, things heated up over the summer and fall. We have been working to respond to Congressional interest in the 340B Program and have been strategizing with other covered entities about how to advocate to protect the program in 2021.

We want to close by wishing everyone a restful holiday break and a happy and healthy new year! A new Congress and new Administration taking office in January will undoubtedly create new challenges and opportunities for the bleeding disorders community. We will do our best to help Alliance members navigate and thank you in advance for your continued advocacy on behalf of the community!

Year in Review
By Jeff Blake

This year has been very busy for the Payer Team. Our focus this year was to increase the number of Hemophilia Treatment Center members that participate in our Hemophilia Alliance Network Services (HANS) PPO Network and to continue our efforts to develop and enhance relationships with the payer community. During the second half of the year, we began our rollout of our new billing and reimbursement services. We have also been working on the development of a Disease Management Program to offer to state Medicaid Agencies and private insurers.

We have seen excellent growth in our HANS PPO Network this year. At the end of 2019, we had fewer than 20 member HTCs participating in the HANS PPO Network and we now have 35 participating HTCs. While this growth has been fabulous, we have a long way to go to have the 80 participating HTCs necessary to comprise a national HANS PPO Network. We will continue to focus our efforts on recruiting HTCs to make the HANS PPO Network a strong national network.

During 2020, we have developed and enhanced many payer relationships. We now have four (4) HANS payer contracts with CareSource, Archimedes Rx, AscellaHealth and Security Health Plan. In addition to these payer contracts, we continue to increase the number of insurance brokers and consultants, insurers, mid-tier PBMs, third party claims administrators, self-funded employer health plans and reinsurance/stop loss carriers we work with. Over the last three (3) years we have been able to bring back more than 36 million bleeding disorder product units back to the HTC pharmacy programs and we want to work with our members to significantly increase this number over the next few years.

In August, we rolled out our new billing and reimbursement services. Our initial focus has been working with our members on specific billing and reimbursement issues they have encountered with payers. Today, we are assisting our members with over $3 million of billing and reimbursement issues with payers. In 2021, we plan to rollout additional reimbursement and billing services to support your pharmacy programs.

This year we continued the development of a disease management program for state Medicaid Agencies and private insurers. We are working with a national consulting firm to develop and pilot this program with at least one (1) state Medicaid Agency. The final development of the disease management program will require gathering some key data elements from our members. During the first six (6) months of 2021, we will be working with members on a survey about costs of dispensing and the cost of providing all the clinical and care coordination services you provide to your bleeding disorder patients.

Thank you for your support of our Payer efforts! We look forward to working with you to make 2021 a more successful year and continuing to work together to grow your pharmacy programs.

Operations Update
By Sean Singh

2020 has zoomed by but I have learned a lot. Zoom seemed to be the word of the year. Prior to this year when I thought of zoom zoom, I imagined myself in a convertible Mazda Miata with the wind blowing through my hair and my left hand floating in the air outside the driver’s window as the television commercials showed us often. Now when I hear zoom, I don’t imagine myself in a car, but I actually see myself in the lower right-hand corner of someone’s kitchen, backyard, living room or home office and every once in a while, a real office.

This year we got really close to seeing you in person but canceled our Spring meeting just 10 days before it was scheduled to occur in March. This led us to our very first virtual Hill Day. It went well and was the beginning of our virtual meetings. We learned that you were very engaged as we put on over 100 webinars. Our fall member’s meeting and new HTC staff meeting was very well attended. Our manufacturing partners have been providing timely topics for their webinars and the response from you to these presentations has been very good. We continue to see you engaged.

We updated our website and our data portal to make it easier to enter your data and to help you help us to capture more information. We have seen an increase in participation in inputting the data in a timely manner and we are thankful for all your help on this.

We launched Harmony in Hemophilia this year, highlighting our efforts to increase collaboration between our member HTCs and local NHF and HFA Chapters. Our first joint webinar included overviews of HFA, Hemophilia Alliance, Hemophilia Alliance Foundation and The Alliance Pharmacy. Our second webinar focused on an update from NHF’s VP of Chapter Services, as well as presentations from two of our member HTCs. Cincinnati Children’s Hospital Medical Center and University of Colorado Hemophilia and Thrombosis Center both discussed details of programs developed through collaboration with their local Chapters. Attendance was very good for both webinars and positive feedback supports our plan to continue the series of webinars in 2021. Our first webinar of the new year will be a 340B presentation, highlighting the history of 340B, how HTCs participate, and the advantages to HTCs and the community. The audience focus for this presentation will be both NHF Chapter and HFA Member Organization members. We are currently seeking suggestions for topics you would like to see highlighted in 2021 which would assist to increase collaboration between your Center and your local patient organization.

As we close out 2020, we thank you for the support you have given us and for the feedback, comments, and recommendations on how we can do things better for you. We have implemented many of your recommendations and look forward to your continued engagement. On a personal note, I want to thank those of you who have shared your homes with us. I have seen some great holiday decorations and also gotten some great decorating ideas. While we have not been able to meet in person, I have felt that we have gotten to know you a little better. We look forward to seeing you in person soon.

Operations Team:
Sean Singh – Senior Vice President
Theresa Parker – Administrator
Karen Bowe – Director of Community Relations

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Meeting Schedule for 2021

Winter/Spring Webinar Series
January – 21st
February – 18th
April – 22nd
May – 20th