In this Issue…

Notes from Joe
· Continued Opportunities and Threats Facing HTCs

Legal Update
· 340B Program Developments: The Latest

Payer Update
· Know Your Patients and their Insurance Status

Alliance Update
· Alliance Seeking Board Nominations
· Join Our Growing Hemophilia Alliance Team
· 2021 Meeting Schedule

Notes from the Community
· CDC Awards Cooperative Agreements to Bleeding Disorders Organizations
· Hemophilia Alliance Foundation Poster at NHF’s BDC Shows Impact of Grants
· NHF Seeks Input for Blue Sky Strategic Plan

Team Alliance Contact Information

Continued Opportunities and Threats Facing HTCs
By Joe Pugliese

As of this writing, we are in something like day 190 of the hostage crisis. It has been a remarkable, chaotic, and frightening time where many things have gone wrong, some things could have gone better, though there are some moments that bring out the best in people. Our thoughts and prayers go out to the people devasted by the recent hurricanes and fires; while it’s still early in the season for both, I know we are all thinking enough already! On the brighter side, many of our manufacturing partners are working on a hyperimuune for COVID-19. What they and our patients could really use, are more donors as plasma collection has fallen by 25% to 35%, which would impact availability of some plasma derived products in the future (likelier to affect other patient communities than ours but we should still do our part!). We all can help by heading to a plasma collection center to reverse the trend – visit https://www.pptaglobal.org/plasma.

While progress on vaccines and treatments seems promising, I do not see us returning to ‘normal’ before the end of 2021 at the earliest, though I would be delighted to be wrong. The Alliance has shifted our 2020 and early 2021 programming to be virtual. The Zoom world is okay in the near term but does not replace the face to face interaction. I know we’re all anxious to be together again.

As was reported last month and updated later in this Newsletter, there has been a tremendous amount of activity in the 340B space, generally all negative. Several manufacturers have now adopted a program called 340B ESP to gather, deidentify and transmit data. While Sanofi is using the program for some of its drugs, it is important to note that Sanofi has given us written assurances that this program does not apply to federally funded HTCs.

There’s a new threat by way of a company called Kalderos, who is proposing changing the 340B discount from from an upfront discount to a back-end rebate. They may have contacted you to pitch on their product, but we caution Alliance members against pursuing this. It would add yet another middleman to the process that just adds costs without adding value. Read on to Issie’s article to learn more about this program and how we’ve been responding.

Both programs argue that manufacturers are at risk for duplicate discounts in Medicaid, but they are solutions in search of a problem. There is scant evidence that duplicate discounts occur and there are already remedies for manufacturers if they feel they are paying duplicate discounts on 340B and Medicaid.

These and other “reforms” or criticisms of 340B are framed around increasing value and lowering costs for the health care system. But what’s frustrating to me is that it so apparent that the best way to increase value and lower costs for our patient population, and then the broader health care system as a result, is by increasing the number of patients who are able to access HTC clinical and pharmacy programs. Just look at the recent CDC retrospective on the impact of the hemophilia treatment center program. Having our patients receive their treatments from their HTC will allow HTCs to have more resources to hire more staff and expand programming to reach even more patients. The idea that adding more middlemen and more hoops to jump through for covered entities is disingenuous at best.

Like we did with the contract pharmacy issue, we are reaching out to our manufacturing partners to express concern about the unnecessary burden these programs would place on HTCs. We are counting on their support to resist these overreaching attempts to undermine the financial well-being of the comprehensive care centers on which the bleeding disorders community relies.

I wanted to close by mentioning that there are opportunities to apply to join the Alliance Board, as well as the Alliance employee team. Read below to learn more about both opportunities and how to apply. Finally, NHF is asking for your feedback to their Blue Sky Initiative, which is your opportunity to weigh in on what we should do to secure the future of the bleeding disorders community. The link is below.

340B Program Developments: The Latest
By Elizabeth "Issie" Karan 

The 340B Program has had an eventful Summer 2020 and Fall 2020 looks much the same. Over the summer, manufacturers took steps to procure extensive pharmacy claims data from covered entities (CEs) for all payers, and to curtail use of contract pharmacies in the 340B Program. This month proposals have surfaced to change the 340B Program from a front-end discount to a back-end rebate. Kalderos, a “prescription drug information technology” company who has partnered in the past with manufacturers to identify duplicate discounts in Medicaid, announced at the beginning of September that it is launching a platform called 340B Pay “to facilitate 340B discounts via a rebate.”

On a webinar on September 11, Kalderos indicated that their program would operate on an NDC-by-NDC basis at the discretion of the manufacturers. Kalderos also stated that if a manufacturer decides to use 340B Pay for a given NDC, then 340B benefits will only be offered as a back-end rebate and covered entities would not be eligible for an upfront discount on the price of the product. Kalderos has started soliciting CEs to sign-up for 340B Pay although they have not indicated which manufacturers or products are participating in the program. Kalderos also said that they have worked with HHS extensively in designing the program but did not indicate that they had received formal approvals from the government.

The Hemophilia Alliance (HA) has significant concerns with utilizing rebates instead of discounts in the 340B Program. Specifically, shifting to a rebate system would disrupt HTCs’ existing cash flow and delay utilizing 340B Program benefits to care for people with bleeding and clotting disorders. Since the late 1990’s, AIDS Drugs Assistance Programs (ADAPs) have utilized a rebate system to obtain 340B Program benefits. However, HHS implemented the ADAP rebate program with a comment process for stakeholders. We remain skeptical that manufacturers could lawfully move the 340B Program to a rebate system without further opportunity for impacted parties to comment.

HA has been working in coalition with other CEs on both congressional and administrative advocacy related to the 340B Program. HA joined with other members of the 340B Coalition in sending a letter to Secretary Azar asking him to investigate the actions of manufacturers. HA also endorsed a letter that Senator Blumenthal (D-CT) sent along with 21 other Democratic Senators to PhRMA CEO opposing the contract pharmacy restrictions and burdensome data requests. Last week, more than half of the members of the House joined together to send a bipartisan letter to Secretary Azar requesting that “immediate action is taken to ensure covered entities continue to receive crucial 340B drug discount.” The letter comes less than two weeks after House Democratic leaders of the House Energy & Commerce Committee made a similar request. HRSA recently made public a letter it sent to Eli Lilly regarding its plans to restrict access to 340B drugs to contract pharmacies, where it cautions the company about the risks of the program and states that HRSA is still evaluating whether manufacturers have violated the 340B statute and whether sanctions may apply.

HA will continue to monitor developments, work with coalition partners on advocacy and defense of the 340B Program and communicate directly with manufacturing partners.

Know Your Patients and Their Insurance
By Jeff Blake

Health Insurance Open Enrollment season has begun. Now is a great time to begin preparing and contacting your patients about their 2021 health insurance to determine if there will be changes that may impact the clinical and pharmacy services you provide.

Sunday November 1st kicks off the open enrollment period for the ACA marketplace plans, which goes until Tuesday December 15th. Given all the uncertainty in the health insurance market, some plans’ premiums are increasing. Despite that, people may be able to enroll in more generous or less expensive coverage than last year depending on their state and individual financial situation. It will pay to shop around. Given the time frame to enroll and the premium changes, we encourage you to contact your patients enrolled on ACA plans to be sure that they reenroll in coverage before December 15.

Some additional items to consider about the ACA for your patients:

1. Even though the ACA Open Enrollment Period is over for 2020, your patient can still enroll in or change a Health Insurance Marketplace plan if they have a life event that qualifies them for a Special Enrollment Period. Please see Healthcare.gov for complete details.
2. If your patient qualifies for Medicaid or the Children’s Health Insurance Program (CHIP), they can apply anytime.

Some additional items to consider for your HTC include:

1. Do you have a solid process in place to track your patients’ insurance?
2. Do you know if their insurance is a fully insured or self-insured plan?
3. Do you know if your Pharmacy Program can dispense clotting factor?
4. Do you need the support and assistance from the Hemophilia Alliance to enhance your Pharmacy Program and Insurance Contracting efforts?

The Alliance Team is here to help. We have developed a Patient Insurance Tracking Spreadsheet and Insurance Questionnaire to assist in your efforts. Please contact one of the Alliance Team Members to discuss how we can assist you in your Payer Relations and Insurance Contracting efforts and always remember We Work for You!

Alliance Seeking Board Nominations
By Heidi Lane, PT, DPT, PCS, Vice Chair, Hemophilia Alliance Board

The Hemophilia Alliance Board Nominating Committee is seeking applicants or suggested nominations to fill one vacancy on the board of directors, with the term beginning January 2021. Interested applicants must support the Hemophilia Alliance mission, vision and programs, be willing to share their knowledge and expertise with the Hemophilia Alliance and be able to participate in bi-monthly board meetings.

In a typical non-pandemic year, the Board meets six times per year, three via conference call and three in-person. Two of the in-person meetings occur at the Hemophilia Alliance membership meetings and one board retreat takes place in January. Again, due to the Covid-19 pandemic, for at least the first half of 2021, all meetings will take place virtually.

Our Mission
The Hemophilia Alliance works to ensure member Hemophilia Treatment Centers have the expertise, resources and public support to sustain their integrated clinical and pharmacy services for individuals with bleeding and clotting disorders.

Our Vision
Through the work of the Hemophilia Alliance, the clinical and pharmacy programs of the Hemophilia Treatment Centers are integrated, stable and sustainable within a changing healthcare environment. They are trusted and respected as the preferred way to provide people with hemophilia and other bleeding disorders access to the full range of care they need.

Applicants or suggested nominees must be employed by a Hemophilia Treatment Center in good standing with the Hemophilia Alliance. Terms are for a 3-year period not to exceed 2 consecutive terms. We seek to broadly represent our membership and are encouraging applicants from all regions and disciplines to apply.

Applicants should submit a letter of interest and resume or CV to Heidi Lane at Heidi.Lane@imail.org by October 23, 2020 for consideration by the nominating committee.

For more information about the Hemophilia Alliance visit our website hemoalliance.org.

FAQs

What does it cost to be on the board?
There is no cost to be on the board.

When does the board meet?
Two in person meetings occur at the Hemophilia Alliance membership meetings, one board retreat takes place in January and three conference calls take place on the fourth Thursday of the month at 2pm EST.

What are the qualifications or degrees needed to be on the board?
You must be an employee of the HTC in good standing with the Hemophilia Alliance. No other qualifications or degrees are needed.

Do I need to hold a particular role in the HTC?
No.

Does my program have to be a large program to be on the board?
Candidates from all types of centers from new startup centers to well established programs are encouraged to apply.

What are some of the things I should include in my letter of interest?

• Your role with the factor distribution program.
• Things that interest you in serving on the Hemophilia Alliance board and what you feel you will bring as a member of the board.
• Include your experience with local, regional, national committees or boards related to hemophilia and related bleeding and clotting disorders.

If you have any additional questions please feel free to contact me at heidi.lane@imail.org.

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Join Our Growing Hemophilia Alliance Team!
By Sean Singh

As we grow and are navigating an ever-changing virtual world, the Alliance is looking to hire an IT person, who ideally also has some experience in the bleeding disorders community. The position will report to the Senior Vice President of Marketing and Operations. The job description and requirements can be found here. For questions about this position, please contact Sean Singh at sean@hemoalliance.org or 727-388-7326.

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Meeting Schedule for 2021

• Spring Members Meeting – Virtual
• Hill Day – Virtual
• Linda Gammage Social Worker Conference – Fall
• New HTC Staff Meeting – Fall
• Fall Members Meeting – September 2021

CDC Awards Cooperative Agreements to Bleeding Disorders Organizations

The Centers for Disease Control and Prevention (CDC) has recently awarded several organizations with funds for new or continuing five-year cooperative agreements with the agency to do projects to benefit the bleeding disorders community. ATHN received funding for Public Health Surveillance for the Prevention of Complications of Bleeding Disorders, otherwise known as Community Counts. As they note in their announcement, ATHN will continue to fund participating HTCs through contracts with regional core centers which will be released in the next month. NHF notes that it received funding for educational programs for patients and healthcare providers in three key areas: inhibitor awareness, treatment for men with hemophilia, and women with bleeding disorders. HFA received funding for educational programs for patients and healthcare providers in two key areas: treatment for men with hemophilia, and women with bleeding disorders. The CDC has been a critical partner of the bleeding disorders community for many years, and we are pleased that it will continue its work on behalf of the community with partners for the next 5 years.

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Hemophilia Alliance Foundation Poster at NHF’s BDC Shows Impact of Grants

During the recent NHF Bleeding Disorders Conference, the Hemophilia Alliance Foundation presented a poster, Longitudinal trends of patient-focused programs in the bleeding disorders community from 2013-20: a retrospective analysis of Hemophilia Alliance Foundation grants. The poster details gaps in funding for national and local bleeding disorders organizations and the unique role that the Hemophilia Alliance Foundation plays in increasing capacity at bleeding disorders non-profits and helping address gaps in community programming and clinical care. The poster shows the impact of the Foundation’s grants, which are only possible due to the support of the Alliance and our HTC members.

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NHF Seeking Comment on Blue Sky Strategic Plan

NHF is working with the bleeding disorders community to envision our future for the next decade, and we need your input. Earlier this summer, we conducted teleconferences, co-moderated by NHF President and CEO Leonard Valentino, MD, with members of the bleeding disorders community, including healthcare providers, chapter leaders, patients and family members, advocacy groups, and NHF board and staff. The goal was to discover what — if money, time, and effort were no object — would the future of the bleeding disorders community look like? We summarized the findings and would like your feedback on the ideas and topics these groups generated.

NHF must be an organization that meets the needs of the entire bleeding disorders community. Please read the summary and let us know your thoughts on the future direction of NHF.

Click here to participate and give your opinion.

Team Alliance Contact Information

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