April 2019 Newsletter

In this Issue…

Notes from Joe
· Three Reasons to Support the HTC Network

Legal Update
· Roadmap for Compliant Expenditures of Federal Funds: Highway to the Danger Zone!

Payer Update
· Payer Update – It’s All About the Data!

Alliance Update
· Spring Into our Services

Notes from the Community
· HFA Announced Archive Project with Smithsonian Institution
· Seeking Director of Community Relations

Team Alliance Contact Information

Notes from Joe

Three Reasons to Support the HTC Network
By Joe Pugliese

Last month, I talked about the importance of HTCs and chapters working together as natural partners in taking care of patients and their families in the bleeding disorders community. Most people know that HTCs were created by an act of Congress in 1975 at the request of the hemophilia community. The support for HTCs was confirmed again in 1992 when HTCs were recognized as original covered entities eligible to participate in the 340B Program.

There are three key reasons that the whole community should champion the US HTC network.

The first of course is superior clinical outcomes for patients. Famously in 1998, Mike Soucie with the CDC confirmed that there was a 30 – 40% reduction in mortality and morbidity in hemophilia patients being seen at federally funded HTCs. We often quote that study and folks say, “it is an old study, how do we know it is still valid?” I am pleased to say we now have son of Soucie, more specifically “Population‐based surveillance of haemophilia and patient outcomes in Indiana using multiple data sources,” which was recently published in Haemophilia. Highlights from the study are noted below:

  • Of the patients receiving care at an HTC, only 17.6% utilized ED services compared to a third of the non‐HTC patients (33.3%).
  • Prophylaxis utilization among patients with severe haemophilia seen at an HTC was 30% higher compared to severe patients seen outside of the HTC network.
  • Most, 89.2% (n = 628) of the study population had insurance during the study period.
    • The primary insurance for 39.3% (247) of our population was private insurance
    • 27.2% (171) had Medicaid
    • 13.1% (82) had Medicare
    • 2.2% (14) had either CHAMPUS or ICHIA state‐sponsored insurance, and
    • 18.2% (114) had an unknown insurance type.
    • The majority of cases without insurance, 57%, were Amish, and 94.7% of all haemophilia patients without insurance were cared for at an HTC.
  • Nearly, 82% of patients with haemophilia visited an HTC; that is, approximately a 15-percentage point difference compared to the national estimate reported 20 years ago.
  • HTC patients with severe hemophilia were 30% more likely to be treated with prophylaxis than patients outside of the HTC network
  • There was a 47.1% lower frequency of ED use among patients being cared for at an HTC compared to patients cared for outside of the HTC network

Twenty-one years later it is clear that patients seen at HTCs have better outcomes, and better outcomes lead to lower costs. Better outcomes also lead to better patient satisfaction, as found in the recent patient satisfaction survey in the bleeding disorders community. The beauty of comprehensive care network is the program income generated from dispensing bleeding disorders therapies is invested into maintaining and expanding the ability of the HTCs to continue to produce these superior outcomes. A clear second reason to overtly support the comprehensive care model.

Finally, the HTC comprehensive care model saves money in three ways: better outcomes, lower unit cost, and lower utilization, a classic win-win-win. Recently, the California Medicaid program has proposed to implement a new reimbursement strategy that recognizes the quality and cost-saving benefits of contracting with the HTC network. I have been asked by many people what I think of this idea, my answer is always the same: it is about time! The benefits are obvious. The proposal is subject to review and approval by the federal government. I hope they look at the overwhelming evidence and approve the state plan amendment.

Legal Update

Roadmap for Compliant Expenditures of Federal Funds: Highway to the Danger Zone!
By Elizabeth “Issie” Karan

Hemophilia Treatment Centers (HTCs) often ask the Hemophilia Alliance legal team how they can compliantly expend grant funds and resources. HTCs can do so in numerous ways. However, as a recipient of a Maternal and Child Health Bureau (MCHB) funds, HTCs are responsible for assuring compliance with the terms of their sub-recipient agreement with the prime, regional grantee recipient as well as the MCHB Regional Hemophilia Network program guidelines. HTCs are also subject to the Department of Health & Human Services’ (HHS’) Uniform Grants Guidance at 45 CFR part 75 (UGG), the HHS Grant Policy Statement, and likely the Regional MCHB Grant program guidance (HRSA 17-074). Please note that alarm bells should go off in your head anytime your HTC wants to give anything of value to a patient for less than fair market cost. Such actions could implicate the requirements of the beneficiary inducement prohibition law and the terms of their (or their host institutions’) private agreements with payers. We recommend working with legal counsel on these matters as they are incredibly fact specific and require individualized advice (although we are always happy to explain the context).

In thinking about how to spend program income in compliance with federal grant rules, we recommend analyzing the key questions described below and asking for advice from experts.

(1) Does this expenditure utilize federal funds, including program income?

The UGG defines what revenue constitutes federal funds and provides general rules for its expenditure. The UGG defines program income in 45 CFR § 75.307 as gross income that a grantee or subgrantee receives that is directly generated by a grant supported activity, or “earned as a result” of the award. Program income includes, but is not limited to, “income from fees for services performed, the use or rental of real or personal property acquired under federally-funded projects, the sale of commodities or items fabricated under an award, license fees and royalties on patents and copyrights, and interest on loans made with award funds.” HTCs must add program income to Federal funds and it “must be used for the purposes and under the conditions of the Federal award” under 45 CFR § 75.307(e)(2). MCHB regards any and all revenue that an HTC earns as program income.

(2) Does this expenditure further the purpose of the HTC grant which is to “promote and improve the comprehensive care of individuals with hemophilia and related bleeding disorders or clotting disorders such as thrombophilia”?

HTC program income must be added to federal funds and “must be used for the purposes and under the conditions of the Federal award.” Under the UGG, the HRSA grants office defines eligible activities to include patient health, education, and supportive services necessary to provide comprehensive care to patients served by the HTCs. If an HTC wishes to use its program income on an expenditure that does not meet the standard of eligible activities, the HTC must first seek and obtain approval from the Regional grantee and, ultimately, HRSA. The approval should be sought and received in writing.

(3) Does this expenditure comply with the grant rules, particularly the rules for procurement and the cost principle restrictions?

The UGG contains numerous other requirements for grantees (which include HTCs). To highlight a few, HTCs must: (1) maximize competition in procurement activities in accordance with the requirements of the UGG; (2) comply with the cost principles prohibiting expenditure of funds on such items as alcohol, international travel, and bad debts; and (3) report deviations from budget or project scope or objective and request prior approvals from HHS awarding agencies for budget and program plan revision. HTCs should familiarize themselves with the UGG and consider regularly educating relevant staff on its requirements.

If you have question, concerns, or would like more information, please contact Elizabeth at ekaran@ftlf.com.


1HHS’ grant administrative regulations are codified at45 CFR Part 75. The Cost Principles are codified in Subpart E of the same Part 75.

2Program Guidance for Regional Grantees, HRSA 17-074, at https://mchb.hrsa.gov/fundingopportunities/?id=b1459a1d-3397-401a-8ba2-bd53829fb76c.

3HRSA Memo to HTC Regional Grantees, dated May 23, 2003, and confirmed in 2011, indicates that all revenue is considered “program income” and must be used for activities that fall within the scope of the HTC program. This is HRSA’s position despite the very limited federal funding and despite legal arguments that only the revenue derived from 340B priced pharmaceuticals should be considered as program income because the 340B eligibility is based upon the subaward and therefore “earned as a result of the grant.”

4See 45 CFR § 75.307(e)(2).

5HRSA Memo to HTC Regional Grantees, dated May 23, 2003

Payer Update

Payer Update – It’s All About the Data!
By Jeff Blake

Why do payers need and want data? And why do I need to agree to an assay management provision in my contract with payers? These are all great questions.

So why is data so important? Payers are concerned about the cost of hemophilia treatment and the pipeline of hemophilia treatment therapies. Payers want to manage and better control the cost of hemophilia treatment and care. This is a great opportunity for HTCs to explain and highlight the value of the HTC integrated comprehensive clinical and pharmacy services model. So how do HTCs do this?

It’s all about the data. HTCs need to have the ability to gather and track key data elements and be prepared to report this data to payers. So, what data are payers interested in seeing? Payers are very interested in assay management; the number of doses patients have on hand when they reorder and the ability to home/self infuse. Why are payers interested in this data?

Solid assay management is key in managing the cost of hemophilia. In general, clotting factor prescriptions are written at specific dose +/- 10%. For some patients, the additional 10% of a prescription can be over 50,000 – 100,000 units of clotting factor that would be dispensed. This can increase the cost to a payer by over $100,000. Rumor has it that our competitors, specialty pharmacies and home care companies, tell payers HTCs are very good at clinic care but not very good at assay management. I agree with their clinical care statement but strongly disagree with their assay management statement.

Payers also want to know their members, our patients, are not hoarding clotting factor. You can track this information when a patient reorders their next doses and by not dispensing “bleed” doses when a prophy patient has not reported any “bleeds” since their last order. Payers also often don’t understand dosage and dispense variation among patients. For example, some assume that every patient is the same; a 300 pound man playing community basketball should have the same dosage and product usage as an 8 year old boy that isn't as active. We often have to explain that many variables can explain product usage and explaining certain patient characteristics is part of the telling the story of how we manage patients and subsequently manage product usage.

Payers are very interested in the lowest cost of treatment. Home/self-infusion is by far the lowest cost of treatment. For example, the cost of clotting factor is 2 – 4 times more costly in the hospital than treating at home. Do you track the patients that can treat at home/self-infuse? Do you document the training provided so patients can treat at home?

So, the key takeaways are – track, manage and report assay management, patient doses at home when ordering and home/self-infusion data to payers. More importantly, let the payers you work with know how well you care and manage your patients!!

If you have any questions or would like our assistance in your payer relations efforts, please contact a member of the Hemophilia Alliance Team. We Work For You!

Alliance Update

Spring Into our Services
By Sean Singh

With our member meeting just around the corner we wanted to remind you of a few things.

We have recently moved. Please update our address to:

Hemophilia Alliance
20 Vine Street, #1227
Lansdale, PA 19446

We realize that things change. We ask that you please take a few minutes to update the contact information for the HTC team members. If your team has changed, please contact Audra as this helps all of us of be more efficient.

Electronic and digital communications continue to be scrutinized by filters and algorithms. Please remember to have hemoalliance.org white listed within your organizations email system to ensure that you receive our emails. Joe and I inform you of current and topical information and we want to make sure you get them. Please check with your IT departments to make sure that joe@hemoalliance.org and Sean@hemoalliance.org are specifically noted as senders you can receive email from.

The membership dues invoice have been emailed to the primary contact at your center. If you have not received your 2019 invoice, please contact Audra at audra@hemoalliance.org. Here is a list of some of the benefits of your membership. If there is something you need help with that is not on this list, please reach out to us as we continue to add to our expertise and services.

Team Alliance Expertise

We give you a national voice in Washington, DC and the expertise of the Alliance consultants which include:

  • Legal and regulatory compliance advice
  • Payer contracting and relations expertise
  • Reimbursement expertise
  • Management experience
  • Advocate in Washington, DC
  • Development of HTC Policies and Procedures
  • Updates via Webinars
  • Access to our website with large libraries of information
  • Newsletter
  • Group Purchasing Services discounts
  • Member meetings
  • Assistance in setting up a pharmacy program
  • Participation in Federal Regulatory Process
  • State Medicaid policy and billing expertise
  • Customized outreach materials
  • Bleeding disorder therapies
  • Nursing and lab services

Group Purchasing Organization Contracts

The Alliance currently has 106 members. Ninety-six of our members are enrolled participating members in the Group Purchasing Organization (GPO). There is no separate fee to be a participating member of the GPO in order to enjoy the benefits and reduced pricing. There is no obligation to purchase products and services under this agreement, but once enrolled you are able to utilize our agreement as you see fit, subject to requirements and restrictions of the individual contracts. In just the past 12 months, GPO participating members have saved in excess of $100,000,000, by taking advantage of the contracts we have available through the GPO. The average savings per participating center was $943,000.

Alliance Benefits the Bleeding Disorders Community

The Alliance gives back to the hemophilia community. The Alliance granted $12,000,000 to the community from 2009-2019. The funding has expanded exponentially since a very modest donation to the National Hemophilia Foundation of $25,000 in 2009. The grants come in three big buckets. First, the Alliance gives a block grant to the Hemophilia Alliance Foundation, an independent nonprofit organization, which granted $731,000 in 2019. Second, the Alliance provides funding to ATHN, which in turn supports ATHN data managers at HTCs across the country. This allows them in their efforts to gather much-needed health data. Finally, the Alliance provides direct funding to national patient organizations. We work closely with National Hemophilia Foundation’s advocacy team and we were pleased to be the inaugural sponsor of the HFA’s (Hemophilia Federation of America) recently-announced Smithsonian initiative that will house the hemophilia history.

We work for YOU our MEMBERS.

Notes from the Community

HFA Announces Archive Project with Smithsonian Institution
By Kimberly Haugstad

Hemophilia Federation of America (HFA) recently announced they have made an initial donation of historical artifacts related to the history of the bleeding disorders community to the Smithsonian Institute's National Museum of American History in Washington, D.C. The donation materials, which include historical artifacts, personal journals, articles, newsletters, other documents as well as photographs, oral histories, including those of HTC physicians and staff, make up the first step in preserving the history of the bleeding disorders community for future generations.

The Hemophilia Alliance has made a meaningful financial contribution to support the first phase of this effort. The Alliance was recognized for this generous support at HFA’s annual Symposium in San Diego on April 5, 2019. Further personal or organizational financial contributions to the bleeding disorders history project are welcome as additional donations/phases of this project continue. Contributions are accepted at https://give.onecause.com/hfa.

We want you to be a member of the Hemophilia Alliance Team

We are looking for a Director of Community Relations. Here is the job description. Interested candidates please send a CV and letter of interest to Sean Singh at sean@hemoalliance.org.

Director Community Relations

The Director of Operations and Member Support reports to the Senior Vice President, Marketing and Operations of the Hemophilia Alliance. The position is responsible for the daily operations and interactions with member centers and external partners. The Hemophilia Alliance operations and member support include but are not limited to:

Key Functions:

  1. Supports the mission of the Hemophilia Alliance “The Hemophilia Alliance works to ensure member Hemophilia Treatment Centers (HTC) have the expertise, resources and public support to sustain their integrated clinical and pharmacy services for individuals with bleeding and clotting disorders.”
  2. Meets with HTCs and institution personnel with a commitment to improve, educate and support the center’s efforts to take care of their patient and sustain their HTC.
  3. Have an understanding and remain current with the 340B Program rules, regulations and potential changes that may impact members.
  4. Work with confidential information and uses discretion when interacting with members, partners, manufacturers and the public.
  5. Public speaking at meetings, conferences, patient events as directed.
  6. Conducts video and phone conferences effectively and efficiently while using current technology in a variety of platforms.
  7. Committed to learning and educating how the Hemophilia Alliance supports the bleeding disorders community.
  8. Have an understanding on working on websites and technology skills. Proficient in Microsoft Office.
  9. Participates in the development and implementation of the approved communications strategic plan.
  10. Participates in Federal and State initiatives that affect the 340B program.
  11. Provides operational training, technical and regulatory guidance and assistance so HTCs can effectively manage and operate their pharmacy programs.
  12. Collaborate with national, state and local patient advocacy organizations.
  13. Attends conferences and trade organization meetings as requested to stay current with market trends and promote member HTCs as Centers of Excellence.
  14. Work with the Hemophilia Alliance GPO, Advocacy, Payer Relations, Membership, and Communication teams/consultants to provide operational support and assistance as necessary.
  15. Assist the Payer Relations Team with their ongoing efforts with insurance payers and member HTCs.
  16. Highly motivated to take on other duties that arise as a result of changes in the bleeding disorders community and the healthcare arena.

Approximately 40% of time traveling to HTCs, conferences, member HTCs and advocacy events is expected. Must possess a valid driver’s license and be able to travel.

This position will be based on the East Coast of the US. The position will cover member centers in the North East.


  1. Knowledge of hemophilia and bleeding disorders that has been gained by working in and or by being a member of bleeding disorders community.
  2. Understanding the business of the healthcare market.
  3. Ability to work independently and on a virtual team.
  4. While working with a team, must be able to set and organize priorities and adapt to frequent change.
  5. Excellent verbal, written and interpersonal communication skills.
  6. Strong analytical, financial and organizational skills.
  7. Highly motivated to use, interact and develop technology.
  8. Willingness to learn and gain knowledge.
  9. Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, vision, mission, goals, and values of the Hemophilia Alliance.

Preferred Qualifications:

  1. Bachelor’s Degree.
  2. Five or more years professional experience in the bleeding disorders community.

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
Karen Bowe karen@hemoalliance.org 717-571-0266
Johanna Gray, MPA jgray@artemispolicygroup.com 703-304-8111
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Elizabeth Karan elizabeth@karanlegalgroup.com 612-202-3240
Kimberly W. Lackman kimberly@hemoalliance.org 813-400-6710
Roland P. Lamy, Jr. roland@hemoalliance.org 603-491-0853
Dr. George L. Oestrich, Pharm.D., MPA george@gloetal.com 573-230-7075
Ellen Riker eriker@artemispolicygroup.com 202-257-6670
Mark Plencner mark@hemoalliance.org 701-318-2910
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Theresa Parker theresa@hemoalliance.org 727-688-2568
Joel Bellucci webmaster@hemoalliance.org 727-504-0491