In this Issue…

Notes from Joe
· Not Quite at the Finish Line Yet

Legal Update
· Protecting HTC Data Requires Reading the Fine Print

Washington Update

Payer Update
· Welcome Kimberly Lackman, the Newest Alliance Employee!
· Payer Relations Update

Alliance Update
· Alliance, NHF and HFA Launch the Harmony in Hemophilia Campaign

Notes from the Community
· Announcing Year 1 of Hemophilia Alliance Foundation Large Grant Award Winners

Team Alliance Contact Information

Not Quite at the Finish Line Yet
By Joe Pugliese

Wow, after waiting 25 plus years for a gene therapy product for the hemophilia community, it never occurred to me that Biomarin’s product would be rejected by the FDA last week with a call for additional data on the durability of their product. If you’ve been traveling (unlikely) or if you just really, really took the week off, here are some links to more info, some of which include quotes from some familiar faces: NYT article, Stat News article, Biopharma Dive article.

The good news is we are blessed with a wide array of highly effective and safe products today, so the wait, which looks like it could be 24 months or so, will be very manageable. It is easy for me to say: I do not have hemophilia. But, I have spoken to many physicians and healthcare professionals around the country, who have dedicated their lives to constantly improving care for people with hemophilia and most agree that it is too soon. Gene therapy is unlike the broad array of fine products available today, since even the latest products have half life. Gene therapy is both irreversible and as has been discussed widely, will be “expensive” (while open to interpretation, the rumored price tags certainly raise the stakes). We have long believed that patients should have access to most appropriate product for them, that will never change.

Gene therapy just makes that decision-making process much more important and “final,” which is why it is a good reason to get it right the first time. I am sure the people at Biomarin are reeling today. In my past lives, I have been on the receiving end of some of these same messages. I also wear rose colored hearing aids; when you tell me no, I hear “not yet.” To all of the researchers and gene therapy companies that have done so much to get us to where we are today, I’d just say that the finish line is still so close, so please keep pushing!

The Alliance has been part of a gene therapy working group since the beginning of the year. It started pretty small, but now includes a group of about 40 clinicians from across the country, as well as NHF leaders. It is one of several working groups focused on making sure that as a community we are prepared to bring gene therapy to market the right way that ensures that patients get the greatest benefit from this exciting new therapy once approved.

We are also focused on making sure that all federally-supported HTCs are prepared to make gene therapy available to their patients. We believe HTCs are the most appropriate sites for the delivery of gene therapy and its follow-up care. There is no place or need for any middlemen. The Alliance has and will continue to build out in house capabilities so we be a full partner with any company bringing a gene therapy product to market.

It sounds like a broken record but gene therapy and all the promise it holds for the bleeding disorders community will be here soon. We will be ready to facilitate patient access to it through a well-funded, comprehensive treatment center network, which was created at the request of the patient community and will always be dedicated to supporting the clinical needs of the community including helping everyone get through these crazy times we are living in.

NHF has recently announced a COVID-19 bridge grant program. I’m proud that the Alliance was delighted to match the donation. See a letter here from our current and past Board members that went to all chapters receiving funds.

Protecting HTC Data Requires Reading the Fine Print
By Mike Glomb and Elizabeth (Issie) Karan 

Under the auspices of 340B Program compliance, manufacturers recently requested extensive data from covered entities related to drugs dispensed through contract pharmacies. Two manufacturers, Merck and Sanofi, are using the same third-party vendor to gather, deidentify, and transmit the data. The platform is called 340B ESP and is operated by a Silicon Valley startup, Second Sight Solutions (Second Sight).  
 
The Hemophilia Alliance is encouraging hemophilia treatment centers (HTCs) to request an exception from reporting from the manufacturer directly. However, Second Sight’s “Terms of Use” provide a practical example of why careful consideration always is necessary before releasing any data to a third party. 
 
Data related to drug transactions is both protected health information, subject to the Health Insurance Portability and Accountability Act (HIPAA), and valuable. The Terms of Use give Second Sight, a “royalty-free, perpetual, irrevocable license” to disclose and sub-license all the data the covered entity submits. This essentially allows Second Sight to monetize covered entities’ data without any compensation to covered entities. In addition, under these Terms of Use, covered entities must: waive the option for a class action lawsuit; submit an invoice number with every claim; submit data on all drugs sold by the manufacturer (not just those related to Medicaid); promise data is accurate; and submit and correct data in the timeframes selected by 340B ESP. Second Sight also disclaims any HIPAA liability in the event of a privacy breach.  
 
In its current form, the Second Sight’s Terms of Use appear to be patently unfair, give manufacturers and Second Sight competitive advantages, do not appropriately compensate covered entities for their data, and create unnecessary administrative burden for covered entities. However, Second Sight is not the only vendor seeking to make money off covered entities’ data. As such, HTCs should always view data requests skeptically and obtain legal counsel before signing any data use agreements or transmitting data to a third party.

By Johanna Gray

As of this writing, the Congressional August recess is waning and all eyes turn to the September calendar, which holds several challenges for policymakers: 

The first challenge is that House and Senate leaders continue their negotiations among themselves and with the White House on another large COVID relief package.  While they were hoping to pass the next COVID bill earlier this summer, they remain far apart on the size, scope and contents of the package.  A number of policies included in earlier packages have expired due to their inaction, such as the enhanced unemployment payments to individuals.  But as the economic and health effects of COVID persist, there remains pressure for Congress to act.  

Congress also must pass the annual federal appropriations bills to fund the federal government before the start of the next fiscal year on October 1, 2020.  The House has passed two big omnibus spending bills to fund most of the federal government (including the health care programs most of interest to our community) but the Senate has yet to begin the process on its versions of the bills.  Accordingly, we expect that Congress will pass a continuing resolution to continue funding at current levels for at least some period of time (perhaps through the election, or maybe into January, when the new Congress takes office).  

I wouldn’t be surprised if these issues get combined as we get into September.  Congress could pass one big bill that funds the federal government and includes some COVID-related policies.  This package could also be a vehicle for other policies, such as ending surprise medical billing.  I think all of us are hopeful that they can reach agreement and avoid a government shutdown (just what 2020 needs!).  It’s shaping up to be an eventful fall.  We’ll continue to monitor all of this activity and advocate to protect funding for our programs and for policies that support our patient and provider communities.

Welcome Kimberly Lackman, the newest Hemophilia Alliance Employee!

We are excited to announce Kimberly Wolverton Lackman has joined the Hemophilia Alliance (HA) Team this month as our Reimbursement and Payer Marketing Manager. In this new role, she will be working with member HTCs and the payer community, supporting, partnering, and advocating to resolve outstanding HTC reimbursement issues, provide root cause analysis, and offer guidance on revenue cycle best practices. She will also be leading our effort to develop and offer reimbursement and billing services to members in the future.

Kimberly is a leader in Revenue Cycle Management, Accounts Payable, Internal Controls, Project Management, Call Center Administration, Training, and Process Improvement. She is a University of South Florida MBA and MHA graduate coming from a global, publicly traded law firm. Her background is in managing the entire Revenue Cycle/Order to Cash processes for both private and publicly traded firms.

Kimberly has continued to exceed expectations and take on additional leadership roles over the past 25 years. As a Project Manager (PM) she successfully led the implementation of new software for Gentiva, Senior Home Care, Amgen, and Baker McKenzie; leading the PM Teams to create policy, procedures, best practices, and identify/quantify/classify root cause analysis of needed system enhancements.

Kimberly has also been recognized for her innovative and proactive approach to managing Accounts Receivables:

• Pinnacle Gold Award Winner, Gentiva
• Caring the Gentiva Way, Gentiva Financial Operations Bronze Medal Winner
• Improving Efficiency & Effectiveness, Gentiva Financial Operations Bronze Medal Winner

Kimberly looks forward to meeting you and providing the reimbursement support services to assist you in managing your payer reimbursement activities.

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Payer Relations Update
By Jeff Amond

A call today can help your stress go away!!

Are you feeling overwhelmed with the number of insurance changes coming your way? Are you struggling to keep your patients under your pharmacy program? Has COVID 19 impacted your patients’ insurance?

If you answered yes to any of these questions, have you thought about reaching out to the Hemophilia Alliance Payer Team for free assistance? The good news for all of you out there who are struggling with these issues is that I along with the rest of the Payer Relations Team have the time and the resources to help. Let us help with your insurance issues, let us help you in retaining your current pharmacy patients and let us help you win back the clotting factor business to your HTC.

The good news to report is that many of you are already doing this. Many HTCs are also requesting monthly or quarterly meetings with a Hemophilia Alliance Payer Team Member to stay on top of ongoing payer issues and/or to alert us to new ones.

We continue to show good success for those HTCs that have reached out to us, but what does SUCCESS really mean. I looked to the definition of success for answers. Part of the definition of success states “a favorable or desired outcome”.

Was it a favorable or desired outcome when the Hemophilia Alliance Network Services (HANS) was able to get an HTC contracted as an in-network provider? Was it a favorable or desired outcome for an HTC when the Hemophilia Alliance Payer Team was able to win back the pharmacy business for a patient that had been lost to a specialty pharmacy? Was it a favorable or desired outcome for an HTC when the Hemophilia Alliance Payer Team was able help them retain the pharmacy business for a patient? The answer to all these questions is YES. We are having SUCCESS and we can have SUCCESS for you.

Please contact the Hemophilia Alliance Payer Relations Team to learn how we can assist your HTC.

Alliance, NHF and HFA Launch Harmony in Hemophilia Campaign
By Karen Bowe

I am happy to announce the launch of our new campaign, Harmony in Hemophilia, aimed at enhancing relationships between our member HTCs, NHF Chapters and HFA Member Organizations. The goal driving our efforts is to facilitate increased awareness of all organizations and positively affect collaboration between the groups.  The Hemophilia Alliance recognizes the importance of partnership during these difficult times and in response, the three organizations are launching a series of joint webinars to address needs within the community as well as increase awareness of programs and services available to benefit members of the bleeding disorders community.  

We’ll begin with an initial webinar to introduce all of the organizations, which will include a short survey to understand current challenges affecting relationships between HTCs and NHF/HFA members. Future topics will be based on the results of the survey, however we will follow the initial webinar with a 340B 101 presentation for the bleeding disorders community, to highlight the history of 340B, how HTCs participate and why, and the advantages to HTCs and the community. 
 
In response to the launch of our campaign, NHF and HFA have included the following comments:

“Hemophilia Federation of America is excited to join with Hemophilia Alliance, National Hemophilia Federation and Hemophilia Treatment Centers across the country to collaborate on initiatives to strengthen the bleeding disorders community.” 

“Hearing from the community is extremely important,” said Dr. Len Valentino, President and CEO at the National Hemophilia Foundation. “This is truly what our Blue Sky Initiative is all about – listening to the community to know what their needs are to serve them the best way we possibly can. The launch of this new campaign aligns perfectly with what we are striving to establish – one community, and one voice.” 

I look forward to continued communication on the progress of Harmony in Hemophilia!   Please contact me with any questions.

Announcing Year 1 of Hemophilia Alliance Foundation Large Grant Award Winners

Congratulations to the Winners!! The Hemophilia Alliance Foundation Board of Directors recently completed the inaugural competitive application process for large grants–$50,000 for a year-long project. The HAF was fortunate to receive funding from the Hemophilia Alliance to fund two projects for 2020/21. Drum roll, please…

The first-year winners are:

1. The Nevada Chapter of the National Hemophilia Foundation whose collaborative proposal with the Idaho and Nevada HTCs will be piloting a project addressing the gap in mental health care specifically in rural communities.
    
2. The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders (CIBD). CIBD is the fiduciary agency for the Physical Therapy Collaborative (PTC) who will work together to address the physical therapy needs of children and adolescents across the country by developing a series of videos which can be provided to patients to improve their PT interventions and assist with managing and preventing bleeding.

HAF received 15 wide-ranging proposals and it was a difficult decision to choose just two. We are thrilled that both chapters/associations and HTCs participated in this process and look forward to 2021 for more innovative, collaborative, and unique ideas that will benefit the bleeding disorders community.

Thank you to all the applicants and the Hemophilia Alliance for providing this funding as well as the time the HAF board contributed to develop the process, evaluating each proposal, and making the funding decisions.

Team Alliance Contact Information

We work for you! Please don’t hesitate to contact any of us with any questions or concerns: