October 2022 Newsletter


In this Issue…

Notes from Joe
· 340B Blues

Alliance Update
· Meet Jennifer Anders!
· Finding Talent Within the Bleeding Disorders Community!
· Update re: Re-Accreditation of Gene Therapy Modules Developed by Partners

Legal Update
· How to Compliantly Increase Visibility of HTCs and the Comprehensive Care Model

Washington Update
· Webinar on Implementation of the Hemophilia Skilled Nursing Facility Access Act Available

Payer Update
· Payer Trends: What You Need to Know

Notes from the Community
· Illinois Ultra-Rare Bleeding Disorders Event a Success

Team Alliance Contact Information

Notes from Joe

340B Blues
by Joe Pugliese, President and CEO

Congress passed the Veterans Health Care Act that created the 340B Program in 1992 and if you are having trouble sleeping you may want wade through the link. The 340B Program has been controversial since its inception. Ironically covered entities were remarkably slow to take advantage of the obvious benefit of the federally-mandated drug discount program. Based on personal experience, for the first two decades the pharma industry simply considered the program a cost of doing business. However, as many have noted, the program has grown substantially in the last decade. Critics describe this growth using pejorative terms, like “an explosion” and say that the program needs guardrails. PhRMA, the industry trade group, devotes a significant amount of time to eviscerating the program and calling for changes, though they fail to mention that their members would be the direct beneficiary of any curtailment of the program, perhaps an important disclosure.

Recently, the pharmaceutical industry has taken a more proactive approach to limiting the program by instituting restrictions on access to discounted products if you use contract pharmacy providers. As usual, our manufacturing partners have not applied these restrictions to HTCs. The bleeding disorders community is very appreciative of their unwavering support. Generally, the restrictions have been focused on the hospital participants in 340B (either because they are DSH (disproportionate share hospitals) and/or children’s hospitals). PhRMA and hospitals have gone to court over this restriction. Everyone agrees the restrictions are hurting the ability of covered entities to generate revenue to support patient care and services.

Historically all of the covered entities – hospitals and grantees – have consistently presented a single voice regarding the obvious value of the 340B program in stretching scarce federal resources and providing care for vulnerable populations. HTCs are grantees under the HRSA SPRANS Program (Special Programs of Regional and National Significance). Recently some of the grantees have broken with this tradition and are calling for changes to the program.

As the smallest participant in the 340B drug discount program, we have long worried that we could be harmed by these debates. We are closely watching these events unfold to make sure that we can mitigate threats. But, we are also aware that change is likely and with change comes opportunity. We are looking for opportunities to build on a program that has been pivotal in providing the financial support for HTCs to provide outstanding clinical care for the bleeding disorders community. (see studies here and here).

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Alliance Update
  • Meet Jennifer Anders!
  • Jennifer AndersJennifer is excited to start her career in the non-profit sector and contribute to the Hemophilia community in new and exciting ways as the first full time team member supporting analytical, reporting, and data needs for the Alliance team and members. Jennifer will be digging into the data from Manufacturers, Members, and beyond. Her responsibilities will include producing reports for internal/external stakeholders, refining analytical and data requirements gathering, and assisting in automating current activities. Her hope will be to bring data to the fingertips of both the Alliance and Members for improved informed decision-making processes that will not only propel the organization forward but support members for years to come.

    She is excited to start working with the data and to learn more about the ways we can make the data work for all of us in strengthening our mission. Prior to joining the Alliance, Jennifer supported data needs for academic organizations, state agencies, and financial institutions. In her spare time, she enjoys sailing, spending time with her dogs, and hiking.


  • Finding Talent Within the Bleeding Disorders Community!
  • We have created a job posting board for positions within our member HTCs, a new feature on our website as an added benefit for our members. We have made the process simple – posting positions on the site is easy! Please send us an email and include the following information:

  1. Position Title
  2. Employment Type (Full Time, Part Time, Temporary, Remote, Internship, Consulting, etc.)
  3. Your HTC website link or URL
  4. The date you’d like the posting to be visible on our website
  5. The date you’d like the posting to be taken offline
  6. Full Job Description (click here for example for an Alliance job posting for a Director of Community Relations)
  7. Email address to receive submissions from candidates
  8. Submit your job posting to jobs@hemoalliance.org

Please let us know if you have any questions.


  • Update re: Re-Accreditation of Gene Therapy Modules Developed by Partners
  • The Hemophilia Alliance is pleased to announce our support for the re-accreditation of the 3 Gene Therapy modules developed by Partners in Bleeding Disorders Education in collaboration with NHF and ATHN.

    The modules are currently on the PartnersPRN.org learning site with continuing education credit. Knowing that continuing education credit is important for maintaining many of the Alliance members’ medical licenses, and in support of the larger mission of Partners to support ongoing learning and training within our HTC community, the Alliance is providing financial support to cover the cost of re-accrediting the following modules:

  • Gene Therapy for Providers 101 course – This learning activity provides basic education on hemophilia gene therapy, including the aims of gene therapy; the packaging, delivery, and activity of the replacement genes; and the means by which the replacement genes lead to production and/or availability of normal clotting factor in persons with hemophilia. The module also reviews important information for discussing hemophilia gene therapy with patients, such as knowledgeable informed consent, outcomes data, and potential risks and benefits.
    • Authored by Steven Pipe, MD & Shelley Crary, MD, MSCS
    • Credit provided: ACCME (0.75); ANCC (0.75); ACPE (0.75)
  • Gene Therapy for Providers 201 & 301 courses – These learning activities are process-oriented intermediate courses that will guide HTC staff through the steps an institution must take to prepare to administer hemophilia gene therapy upon commercial availability of these products. Topics include: Patient eligibility, selection, and decision making; guidance on gene therapy administration; preparing patients, HTCs, and hospital system for administration of gene therapy; and short and long-term monitoring and management after gene therapy administration.
  • Gene Therapy for Providers 201
  • Authored by Courtney Dawn Thornburg, MD, MS; Ulrike Margret Reiss, MD; & Rebecca Kruse-Jarres, MD, MPH
  • Credit provided: ACCME (1), ANCC (1.0), ACPE (1.0)
  • Gene Therapy for Provider 301
  • Authored by Doris V. Quon, MD & Lindsey A. George, MD
  • Credit provided: ACCME (1), ANCC (1.0), ACPE (1.0)
  • HOW TO VIEW: Visit PartnersPRN.org. Sign into your account and enroll in the modules. In order to qualify for credit, you must complete all steps in the “To Do” section of the module including reviewing the disclosure, viewing the presentation, and completing the evaluation survey and post. The modules are available until October 13, 2023.

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Legal Update

How to Compliantly Increase Visibility of HTCs and the Comprehensive Care Model
by Elizabeth “Issie” Karan, Legal Counsel

Recently, several Hemophilia Treatment Centers (HTCs) have inquired about the rules and any limitations on marketing their programs. As described further below, these activities can be vital to HTC operations and have support in programmatic guidance.

The request for applications for Regional Hemophilia Networks from the Maternal Child Health Bureau (MCHB) includes language that suggests HTCs must engage in outreach efforts. More specifically, the Funding Opportunity Announcement from 2016 states that for patients with hemophilia and blood or clotting disorders that are seen within HTC subawardees in a region, grant program is intended to:

  • Increase family engagement
  • Increase patients with medical home
  • Increase transitions to adult health care
  • Increase number of patients with hemophilia and related blood or clotting disorders that have had an annual comprehensive care
    (Regional Hemophilia Network, HRSA-17-074, page 5)

Additionally, HTCs are instructed to “identify, prioritize, and address emerging issues of importance, including increasing access to, and the improvement of, hemophilia and related bleeding and clotting disorder services through outreach to underserved populations in conjunction with key stakeholders.” (HRSA-17-074, page 2) As this language highlights, HTCs must find ways to connect with patients in their areas, particularly those not currently being treated under the comprehensive care model.

The Uniform Grants Guidance (UGG) provides somewhat conflicting guidance on advertising. 45 CFR §75.467 states that costs associated with selling and marketing services, or goods is typically unallowable. However, 45 CFR §75.421 describes allowable expenditures on advertising and public relations to include program outreach and other specific purposes necessary to meet the requirements of the Federal award.

Given the emphasis on these activities in the Funding Opportunity Announcement from MCHB, HTCs likely can conclude that the government expects them to devote resources to connecting with the patient community. However, whenever in doubt, HTCs can check with their regional leadership or reach out to the Hemophilia Alliance for more guidance.

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Washington Update

Webinar on Implementation of the Hemophilia Skilled Nursing Facility Access Act Available
by Ellen Riker, Advocacy Consultant

On October 18, the Hemophilia Alliance with the National Hemophilia Foundation hosted a webinar for HTCs on the implementation of the new Medicare coverage policy allowing for separate payment for bleeding disorder treatments for patients in skilled nursing facilities (SNFs). The webinar included presentations by Pamela Truscott, Director of Clinical and Regulatory Services at the American Health Care Association (AHCA, the trade association for SNFs) and Assisted Living Facilities and Amanda Wetzel, a SNF Consolidated Billing Specialist, who works with AHCA, who provided important details on SNF staffing and practices and how the provision of services will occur. A recording of the webinar can be found here.

The Alliance is planning a second webinar for HTCs to share their success stories on the placement of Medicare patients in SNFs and billing for treatments under Medicare Part B. Stay tuned for more information.

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Payer Update

Payer Trends: What You Need to Know
by Jeff Blake, Senior Vice President Payer Relations

Over the last few years, the Payer Team has established strong relationships with several national insurance brokers and consultants, stop-loss/reinsurance carriers, insurance companies/third party claims administrators and mid-tier pharmacy benefit managers. These payers and advisors work with employers that offer self-insured health plans, to manage their health plan expenditures and design.

So, what have we learned over the last few years and what are some of the trends?

  1. Employers continue to focus on enhanced management of high-cost complex claims – including bleeding disorders. All eyes are on HTCs, products prescribed and dispensing pharmacy practices.
  2. Health plans continue to utilize copay accumulator and maximizer programs and the trend of Alternative Funding Programs, excluding high-cost specialty drugs from coverage and steering patients to manufacturer free product programs, continues to increase. Based on a recent survey, more the 10% of employers are currently utilizing Alternative Funding Programs and it is expected to grow to 40% over the next few years.
  3. Some payers are now requiring performance guarantees with penalties in their contracts with HTCs. Guarantees include Assay Management and avoidable emergency department visits. We were recently asked to include an Assay Management guarantee in an individual Letter of Agreement (LOA).
  4. Bleeding disorders product pricing and reimbursement rates are getting more competitive from all payers, including State Medicaid Programs. Our competitors want to grow their business just like our member HTC pharmacies. The rates our competitors are charging payers continues to decrease, so HTC pharmacies must continue to review their bleeding disorders reimbursement rates to remain competitive.
  5. Self-insured employers and their brokers/consultants are very willing to work with HTCs and their pharmacy programs to reduce the cost of the bleeding disorder medication. Many times, this requires an individual Letter of Agreement (LOA) between the employer’s health plan and the HTC.
  6. The Hemophilia Alliance Team typically receives 3 – 5 broker/consultant requests each week to evaluate potential savings by moving the bleeding disorders medication from a commercial specialty pharmacy to a member HTC pharmacy. Below are additional items we have determined in our work with these brokers/consultants:
    1. 5% – 10% of the time the HTC and their pharmacy program are already providing the clinical and pharmacy services. No changes are necessary – the employer has the best deal.
    2. The remaining 90% – 95% of the time there is an opportunity for the HTC and their pharmacy program to get new business.
    1. When the Hemophilia Alliance and the HTCs can respond to these opportunities quickly (within 5 – 10 business days) and with competitive pricing for the bleeding disorders medication, we are more likely to win the business for the HTC pharmacy.
    2. When it takes us longer than 2 weeks to respond, their interest in our response has significantly declined and they have moved on to other hot items. Often, we cannot get them re-engaged in our proposal.
    3. If your HTC is operating its pharmacy program exclusively through contract pharmacy arrangements with pre-determined pricing, consider signing a contract pharmacy arrangement with The Alliance Pharmacy (TAP). This provides a low-cost option for administrative services but more importantly creates an opportunity to offer flexibility in product pricing as the payer team helps your HTC acquire business.
  1. The payer community has gained an enhanced understanding of the HTC model of care and how integrating the medical care with the HTC pharmacy can improve outcomes and save money. This has been very helpful in our discussions with payers related to Gene Therapy and other novel therapies in the pipeline.
  2. Payers continue to gain interest in contracting with Hemophilia Alliance Network Services (HANS). We now have 6 payer contracts – CareSource, Aultcare, Centivo, ArchimedesRx, AscellaHealth and Security Health Plan and we are working with a few other payers on potential HANS contracts.
  3. Forty-two (42) HTCs have signed the HANS PPPO Agreement. If your HTC has not signed the HANS PPO agreement to participate in HANS payer contracts, now is an excellent time to sign up.

If you would like additional information about the HANS PPO Agreement and our payer relations activities, please contact a member of the Hemophilia Alliance Team. We Work for You!!

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Notes from the Community

Illinois Ultra-Rare Bleeding Disorders Event a Success
by Bob Robinson, Executive Director of the Bleeding Disorders Alliance Illinois (BDAI)

The Bleeding Disorders Alliance Illinois (BDAI) brought together an amazing group of more than 50 people with Ultra-Rare Bleeding Disorders for the Ultra-Rare Bleeding Disorders Community Meet-Up on the weekend of September 9 – 11. Thanks to generous grants from Global Genes and the Hemophilia Alliance – this event – one of the first of its kind, developed from work BDAI is doing to address barriers to care for people with inherited bleeding disorders.

This activity was an important step in identifying and addressing the significant challenges people with URBD’s face compared to the broader bleeding disorders community. It helped build a healthier and stronger experience for all involved giving participants the opportunity to connect with others with the same or similar ultra-rare bleeding disorders and spend time with hematologists from federally funded hemophilia treatment centers, and other professionals who addressed questions and assisted in creating a clear path to addressing on-going healthcare concerns.

More than a dozen different rare disorders were represented. Several participants had never been to an advocacy event with the bleeding disorders community ever in their lives. This was such a great start to bringing people together ending the isolation and loneliness caused by being RARE! This group of brave individuals committed to keeping this program going pledging to create a Bill of Rights for People with URBDs and started planning a follow-up event to learn how to be Ambassadors to spread the word to more people with these conditions.

In addition to our sponsors—Global Genes & the Hemophilia Alliance— we also thank our Exhibitors—the Bleeding & Clotting Disorders Institute, BPL Laboratories, HemaBiologics, Novo Nordisk, Optum and Rush Hemophilia and Thrombophilia Center. Finally, we share this success with our speakers: Lisa Boggio, MD; Stacey J. Feuer, PsyD, MLD; Iftikhar Haider, PhD; Maria Santanella, MSN, RN-BC, CPHON; and Michael Tarantino, MD.

For more information about this event and to be involved in our future activities for the ultra-rare bleeding disorders community contact: Bob Robinson, Executive Director, BDAI—brobinson@bdai.org or 708.254.3309

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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:

Name Email Phone
Joe Pugliese joe@hemoalliance.org 215-439-7173
Sean Singh sean@hemoalliance.org 727-388-7326
Jeff Blake jeff@hemoalliance.org 317-657-5913
Jeff Amond amond@hemoalliance.org 608-206-3132
Jennifer Anders jennifer@hemoalliance.org 954-218-8509
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Johanna Gray, MPA jgray@artemispolicygroup.com 703-304-8111
Karen Bowe-Hause karen@hemoalliance.org 717-571-0266
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Elizabeth Karan elizabeth@karanlegalgroup.com 612-202-3240
Roland P. Lamy, Jr. roland@hemoalliance.org 603-491-0853
Dr. George L. Oestrich, Pharm.D., MPA george@gloetal.com 573-230-7075
Theresa Parker theresa@hemoalliance.org 727-688-2568
Mark Plencner mark@hemoalliance.org 701-318-2910
Ellen Riker eriker@artemispolicygroup.com 202-257-6670

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