June 2018 Newsletter

In this Issue…

Notes from Joe and Marisela
· Impact of 340B on HTC Services Article Published

Legal Update
· Reminder: What Are the Rules around Grant Funds and Use of Program Income?

Payer Update

Alliance Update
· Save the Date for 2018 Events!

Notes from the Community
· Hemophilia Alliance Foundation Releases Dates for Upcoming Grant Cycle
· FWGBD Announces Winners of the 2018 Promoting XXcellence in Women’s Health: Optimal Management of Women and Girls with Blood Disorders and Bleeding Disorders Research Awards

Team Alliance Contact Information

Notes from Joe and Marisela

Impact of 340B on HTC Services Article Published
By Marisela Trujillo, Hemophilia Alliance Board Chair

Regular readers will note that I have become increasingly concerned about the attacks on the 340B Program. I am taking the month off from Notes from Joe and turning it over to our Board Chair, Marisela Trujillo. Marisela and her fellow researchers, including previous HA board member Laurel McKernan, demonstrate just how critical the program is for comprehensive hemophilia care model and the patients they serve. Thanks to Rebecca, Laurel, Ann, Dunlei, John, Kathryn and Marisela. I would encourage everyone reading this to share the article widely within and outside our community. Joe

Those who work in an HTC can see the impact of the 340B Pharmacy Program daily, through patient services, staffing and education. Patients who benefit from the program are most often unaware the program exists. Sometimes it is difficult to concretely define the contributions that happen as a result of HTCs operating a 340B Pharmacy Program, so it is a great reminder when information can be shared on a wider stage.

The recently-published article “Impact of the 340B Pharmacy Program on Services and Supports for Persons Served by Hemophilia Treatment Centers in the United States” is an example of how income generated through a 340B HTC program is utilized for patient care. This article was a result of a project developed by staff and consumers participating in 340B programs, including HRSA MCHB Director Kathryn McLaughlin, to collect data on the use of program income by HTCs. The Hemophilia Alliance membership offered important suggestions from the beginning of the project and contributed non-identified data on services offered by their HTCs.

The article is a great tool that supports why keeping the 340B Program around is vital to our community. Although many services through the integrated comprehensive care model are non-reimbursable, the level of care at an HTC is high quality that is heavily supported by 340B Pharmacy Program income. We look forward to sharing this message about the work that is done at HTCs through the use of 340B program income.

You can access the article here. We encourage you to share it far and wide!

Legal Update

Reminder: What Are the Rules around Grant Funds and Use of Program Income?
By Elizabeth (Issie) Karan

For all expenditures of grant funds, federal grantees must abide by the rules governing the administration and expenditure of federal funds, and the programmatic requirements of their grant. For Hemophilia Treatment Centers (HTCs), this include the statute that created the HTC program; the rules for spending federal funds under the Uniform Grants Guidance (UGG); the guidelines put forth by the Maternal and Child Health Bureau (MCHB); and the terms of their Notice of Award or sub-award agreement (as applicable). Under the law, the statute gets the most deference followed by rules which have undergone a formal notice and comment process, such as the UGG, and finally informal guidance. This article reviews the rules for administration of grant funds and for implementing the HTC program to help HTCs determine what are allowable expenditures, including requests from host institutions to spend grant funds on inpatient costs.

What revenue is considered grant funds and subject to the federal rules?

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 all revenue that an HTC earns as program income, including revenue from factor sales. In 2005, MCHB released the HTC Manual for Participating in the Drug Pricing Program Established by Section 340B of the Public Health Service Act (July 2005) (HTC 340B Manual). The HTC 340B Manual states on page 29 that: “In brief, FRP (factor replacement product) revenue, whether or not the HTC is a 340B covered entity, is program income and subject to the rules for that kind of income in the grant regulation and the policy statement.” Meaning, any revenue derived from HTC patients filling their prescriptions written by doctors as part of the HTC’s outpatient clinic activities is subject to program income rules. Therefore, this revenue must be restricted to expenditures that will benefit the HTC and its patients.

What are allowable expenditures for grant funds by HTCs?

HTC funding is authorized under §501(a)(2) of the Social Security Act, the Maternal and Child Health Federal Set-Aside Program, Special Projects of Regional and National Significance (SPRANS) (42 U.S.C. 701(a)(2)), which states the following:

“…for the purpose of enabling the Secretary (through grants, contracts, or otherwise) to provide for special projects of regional and national significance, research, and training with respect to maternal and child health and children with special health care needs (including early intervention training and services development), for genetic disease testing, counseling, and information development and dissemination programs, for grants (including funding for comprehensive hemophilia diagnostic treatment centers) relating to hemophilia without regard to age, and for the screening of newborns for sickle cell anemia, and other genetic disorders and follow-up services”

The statute is short and does not provide extensive direction on what would be considered an “allowable” grant expenditure for an HTC. However, there are other documents from the MCHB that provide more guidance.

Each regional core center applied to MCHB to receive grant funds by responding to a Notice of Funding Opportunity (Regional Hemophilia Network HRSA 17-074), most recently in 2016. The regional core center is considered the prime recipient of the grant, and distributes the grant funds to other entities within its region through sub-awards or sub-grants. Although we have not reviewed every sub-award agreement, all likely incorporate many of the requirements of the Notice of Funding Award and the prime recipient’s Notice of Award which will flow down to the HTC, as the sub-recipient. MCHB defines eligible activities to include patient health, education, and supportive services necessary to provide comprehensive care to patients served by HTCs.

The question of whether or not an HTC could use program income for inpatient losses regularly comes up for HTCs housed within larger institutions. There is no specific prohibition against spending grant funds for inpatient costs. However, our position is and continues to be, that expenditures for inpatient costs would only be appropriate if it furthers the purposes of the HTC grant. Offsetting inpatient losses never fulfills the purpose of the HTC program which is to “promote and improve the comprehensive care of individuals with hemophilia and related bleeding disorders or clotting disorders such as thrombophilia.” As such, those expenditures would not be allowable under the federal grant rules.

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

Payer Update

Payer Team Update
By Jeff Blake

The Payer Team has been working with several HTCs on payer relations and payer contracting issues. The results to date have been very favorable; we have helped HTCs retain, add and bring patients back on the HTC’s Pharmacy Program. Your input and ability to identify key issues past, present and future is critical to our success.

As you can imagine, data is the key element in addressing payer issues. The Alliance Team is here to help you organize your data and work with you. Below are the key steps in working together:

  1. Complete the HTC Insurance Questionnaire (available here)
  2. Complete the HTC Patient Insurance & Clotting Factor Utilization Spreadsheet (available here)

This data will provide you and the Alliance Team the necessary baseline information needed to evaluate and create a strategy to work together to solve your payer issues. However, it is very likely additional information will be needed, which may include patient protected health information (PHI). As a result, the Hemophilia Alliance is now signing Business Associate Agreements (BAAs) with HTCs. We recognize that HTCs and/or Institutions have standardized BAA forms that we are happy to review and sign. With signed BAAs, the Alliance Team is able to have patient-specific discussions with payers and insurance brokers/consultants. This has been extremely beneficial in solving payer relations and contracting issues and in identifying competitive payment information to help achieve patient retention and acquisition goals for HTCs.

Do you have payer relations and contracting issues? Contact an Alliance Team staff/consultant to assist in solving payer issues. Remember, WE WORK FOR YOU!

Alliance Update

Save the Date for 2018 Events!

Save the date for Alliance events in 2018, including:

  • September 23-25: Alliance Members Meeting in Las Vegas – Register Here

Notes from the Community

Hemophilia Alliance Foundation Releases Dates for Upcoming Grant Cycle

The Hemophilia Alliance Foundation has released dates for its upcoming grant cycle, which are:

  • Call for Applications posted on web site 12/1/18
  • Applications Due 1/31/2019
  • Review and Grants awarded by Foundation Board 2/28/2019
  • Award letters and checks sent 3/15/2019
  • Grant year starts 4/1/2019
  • Six Month Progress report due 10/15/2019
  • Final Report due 4/30/2020
  • Grant process survey 4/30/2020

For more information, please visit: http://hemophiliaalliancefoundation.org/.

FWGBD Announces Winners of the 2018 Promoting XXcellence in Women’s Health: Optimal Management of Women and Girls with Blood Disorders and Bleeding Disorders Research Awards
By Kerry B. Funkhouser, Executive Director, Foundation for Women & Girls with Blood Disorders

The Foundation for Women & Girls with Blood Disorders (FWGBD) has announced the two winners of the 2018 Promoting XXcellence in Women’s Health: Optimal Management of Women and Girls with Blood Disorders and Bleeding Disorders research fellowship awards.

The 2018 awardees, along with brief descriptions of their research proposals are below:

Bleeding Disorder Award Winner:
Julia Coleman, MD, University of Colorado – Denver
Sex Dimorphisms in Trauma-Induced Coagulopathy: A Mechanistic Exploration of a Sex-Specific Survival Benefit

Project Description: Dr. Coleman will investigate whether sex hormones affect clot formation and stability, thrombin formation and platelet function in vitro and whether differential levels of sex hormones in vivo may confer differential thrombelastographic profiles in female populations and outcomes in female trauma patients.

Blood Disorder Award Winner:
Tazim Dowlut-McElroy, MD, MS, University of Missouri-Kansas City
Use of Levonorgestrel-Releasing Intrauterine Device for the Treatment of Heavy Menstrual Bleeding in Adolescents with Bleeding Disorders
Project Description: Dr. Dowlut-McElory will investigate whether the LNgIUD results in improvement in menstrual blood loss and quality of life in adolescents with bleeding disorders who have heavy menstrual bleeding.

About this Award
This award is a critical program in FWGBD’s overall strategy to foster and sustain interest and knowledge of the next-generation of healthcare providers working in blood or bleeding disorders affecting women/girls. Additionally these awards support researchers who are able to demonstrate an active, working collaboration with a peer in the related discipline – Ob/Gyn for the Hematology applicant and Hematology for the Ob/Gyn applicant. These collaborations help FWGBD reach a shared vision of ensuring that all women and girls with blood disorders receive a proper diagnosis, treatment and management across their lifespans.

The 2019 Promoting XXcellence in Women’s Health: Optimal Management of Women and Girls with Blood Disorders and Bleeding Disorders award cycle will begin accepting applications in January 2019.

For more information about this year’s award recipients and their projects, visit www.fwgbd.org.

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