Latest News

June 2017 Newsletter

In this Issue…

Notes from Joe
· 340B Debate Continues to Heat Up

Payer Update
· Hemophilia Alliance Network Services Signs its First Payer Contract

Washington Update
· Senate Leaders Release Better Care Reconciliation Act (BCRA) to Repeal the Affordable Care Act

Legal Update
· Another Delay in Implementation of the UGG’s Procurement Standards

Notes from the Community
· Thank you to the Alliance for the Advanced Social Work Training!

Alliance Update
· Hemophilia Alliance Participation at Regional Meetings
· Hemophilia Alliance goes to the Hill with THSNA
· Alliance Meeting Updates for 2017 and 2018
· Team Alliance Contact Information

Notes from Joe

340B Debate Continues to Heat Up
By Joe Pugliese

The 340B wars, like the summer temperatures, continue to heat up. There have been a new series of newspaper articles about hospital participation in 340B, the House Energy and Commerce Committee has gone back to letter writing – and will potentially hold a hearing on 340B this summer, and President Trump’s impending executive order on drug prices may affect us as well.

I am in the unique position of having been on the manufacturer side of the business for the first 12 years of the program and on the provider side for the second 12. I am puzzled by policymakers’ priorities and much of the rhetoric around 340B. The broader pharma community blames 340B for their high drug prices, arguing that they have to offset the discount by raising prices. In any event, our community is proof of the error of these arguments.

HTC and 340B purchases make up a significant percentage of hemophilia products, as opposed to the modest 5% in the entire 340B Program. Yet, all manufacturers of importance have hemophilia product contracts with the Alliance GPO, supporting HTCs by providing drug discounts that are used to strengthen HTC capacity and services. In addition, nearly every manufacturer of importance has written letters of support for HTCs to continue to be funded through the MCH/SPRANS grant and support HTC access to 340B pricing to support a clinical care model that is emulated around the world.

You would think these manufacturers would be on the ropes after being ‘forced’ to give discounts in support of patient care. The reality is we have seen an unprecedented level of investment in innovative, new and improved therapies. Many new, truly innovative products have just recently come to market and an equal number will be here in the next 5 months to 5 years. You just don’t see multiple companies investing heavily in anything, let alone a rare disease community, if there are not adequate potential financial rewards.

Payer Update

Hemophilia Alliance Network Services Signs its First Payer Contract
By Jeff Blake

Earlier this year, The Hemophilia Alliance created “Hemophilia Alliance Network Services” (HANS) as a way to offer new opportunities for engaging third-party payers. HANS was created to be the payer contracting entity that negotiates and signs any insurance payer contract that we negotiate on behalf of members. HANS also serves as a Pharmacy Services Administrative Organization (PSAO). A PSAO negotiates reimbursement rates and contract terms for participating members and can also serve as the claims processor for participating members.

HANS is pleased to announce that it has signed its first payer contract with CareSource, a managed care company headquartered in Dayton, OH. The Agreement covers HTC clinical and pharmacy services, including dispensing clotting factor products. CareSource offers a variety of insurance products in several states. The HANS Agreement includes all states they currently operate in and products they offer, including:

State Insurance Products Offered Ohio Medicaid Managed Care, Health Insurance Exchange and Dual Eligible Medicare & Medicaid (Ohio MyCare) Kentucky Medicare Advantage and Health Insurance Exchange Indiana Medicaid Managed Care, Medicare Advantage and Health Insurance Exchange Georgia Medicaid Managed Care West Virginia Health Insurance Exchange

HTCs located in the States above have been contacted about this new opportunity. However, CareSource has future plans to expand into additional states. As expansion occurs, we will add the new states and any new products to our Agreement and reach out to HTCs about this new opportunity.

If you have any questions or would like additional information, please contact Jeff Blake, SVP Payer Relations, at or 317.657.5913.

Washington Update

Senate Leaders Release Better Care Reconciliation Act (BCRA) to Repeal the Affordable Care Act
By Johanna Gray

On June 22, 2017, Senate Republican leaders released their legislation to repeal and replace the Affordable Care Act (ACA). Called The Better Care Reconciliation Act (BCRA), the bill has some minor improvements over the House-passed American Health Care Act (AHCA), but there are other ways that it would be more damaging. There are a number of very concerning policies that would harm the bleeding disorders community.

The Congressional Budget Office has estimated that 22 million more people would be uninsured due to the policies in BCRA relative to current law, including 15 million people who would be uninsured next year. For people who maintain coverage, plans would cost more and cover less. In particular, the bill would: • Undermine the ban on lifetime and annual limits by allowing states to waive essential health benefits (EHB) policies. Since lifetime and annual limits are only banned for services defined as EHBs, any narrowing of EHB requirements will allow limits to come back. • Undermine the ban on pre-existing conditions exclusions. While plans couldn’t set premiums based on health status (as they could in the house bill), plans could simply not cover treatments for expensive conditions. • Repeal the Medicaid expansion and implement strict funding caps, which will jeopardize access to care as states respond to decreased federal funding. Due to the partisan split in the Senate being so close (52 Republicans to 48 Democrats), every single Senator is important to this vote. As many as 10 Republican Senators have indicated opposition to the bill as currently drafted, which delayed a planned vote for this week. But we can’t rest easy yet! Negotiations continue and a vote could happen soon after the July 4th holiday.

I encourage all members of the bleeding disorders community to call their Senators – both Republican and Democratic – to express opposition to the bill. NHF and HFA have put out action alerts on their websites or you can simply call the Capitol Switchboard (202-224-3121) and ask to be connected with your Senators’ offices. Please contact me with any questions.

Legal Update

Another Delay in Implementation of the UGG’s Procurement Standards
By Feldesman Tucker Leifer Fidell LLP

The Uniform Grants Guidance articulates standards with which all federal grant recipients, including HTCs, must comply when acquiring property or services. These requirements, termed the “Procurement Standards,” are set forth at 45 C.F.R. §§ 75.326 through 75.335 and focus primarily on maximizing competition in purchasing.

For HTCs, the new Procurement Standards are much more prescriptive than prior requirements. Likely for this reason, the Uniform Guidance provided an elective one-year grace period for application of the revised standards, instructing:

For the procurement standards in 45 CFR 75.326 through 75.335, non-Federal entities may continue to comply with the procurement standards in previous OMB guidance (superseded by this part as described in 45 CFR 75.104) for two additional fiscal years after this part goes into effect. If a non-Federal entity chooses to use the previous procurement standards for an additional two fiscal years before adopting the procurement standards in this part, the non-Federal entity must document this decision in their internal procurement policies. 45 C.F.R. § 75.110(a)

In other words, a grantee could elect to continue to apply prior standards until the beginning of its first fiscal year commencing on or after December 26, 2015.

On September 10, 2015, this grace period was extended to two fiscal years.( 80 Fed. Reg. 54,407, 54,408 (Sep. 10, 2015)). On May 17, 2017, it has been further extended to three fiscal years. (80 Fed. Reg. 54,407, 54,408 (Sep. 10, 2015)).

Under this revised implementation schedule, so long as a grantee has not already applied the new Procurement Standards, it may continue to elect to apply prior standards until the beginning of its first fiscal year commencing on or after December 26, 2017.

The Federal Register notice extending the grace period is available here.

Notes From the Community

Thank you to the Alliance for the Advanced Social Work Training!
By Samantha Carlson LMSW, OSW-C, ACHP-SW, Director of Social Services, West Michigan Cancer Center and Institute for Blood Disorders

In February, 2017 I had the opportunity to attend the Advanced Social Work training facilitated by the Hemophilia Alliance. The focus of continuing education for social workers practicing in the blood disorder arena has been a unique and fantastic opportunity to network, learn and grow together. Clinical social workers in a treatment center address issues spanning from basic needs (housing crisis, financial strain, transportation to complex psychosocial issues (such as anxiety, depression, suicidal ideation, trauma, and more). While the core competencies for masters level social work clinicians meets the needs of many, the blood disorder community is unique and complex. In so many of our treatment centers, we cover numerous hematology and oncology clinics, and psychosocial education on blood disorder patients is rare. The Hemophilia Alliance seeks input from seasoned social workers through an advisory council for topics and trends to improve skills and knowledge.

This year’s topic of continuing education addressed domestic human trafficking. It is a growing epidemic of profound trauma and surprisingly is often facilitated by the victim’s family, friends, or parents. In our state, our licensure requires training specific to this issue. The Hemophilia Alliance is on the forefront of providing imperative training to clinicians that can be life changing for their patients. As my colleagues and I participated in the session, we were appalled at the realization of previous patients we have served in our practice that may have been victims of human trafficking. We are well versed and skilled in discussing trauma, domestic violence, sexual abuse, and neglect- however human trafficking is a completely different level of manipulation, abuse and exploitation-mentally, physically, and sexually. The training provided tangible skills to look for signs, articulate concern and evaluate suspected victims.

Just a few months later, I was asked to see a patient who has consistently neglected their appointments, “no show, no called” on specific tests and vital medical care. The nurse, physician, and medical assistant were all extremely frustrated with the case, and asked me to see the patient as a last result. I had met them before, and I provided a review of my role in our Center, and expressed concern about basic needs and support for appointments. The patient’s reply was the following: “I remember you, and I appreciate your concern. I thought about calling you, but I don’t trust many people. This is going to sound crazy, but I really have a hard time getting here…emotionally”. The patient continued the discussion by disclosing during childhood, their mother sexually trafficked them (including siblings) to pay for drug addiction. The trauma of the experience causes significant anxiety, depression, suicidal thoughts, sleep disturbance, and aversion to medical appointments. Having just returned from the training, I was able to help this patient with confidence in an arena I was previously not as well versed in; building instant trust with disclosing the training and validating the impact on their healthcare behaviors. We created a plan moving forward to ensure quality care at the patient’s comfort level, and coordination with the team for support and discussion. Moreover, we were able to refer them to a national resource to help begin to heal from trauma. The training directly impacted the life of this patient.

The Hemophilia Alliance has invested in the social work clinicians serving the community by providing this training, and I, my colleagues, and my patients are extremely grateful for the opportunity to help better serve our community. Impressively, the leadership of the Hemophilia Alliance attended the training with us, including Joe Pugliese (President) and Sean Singh (Senior Vice President). Their support of our clinical role in comprehensive care has transcended to other hemophilia foundations who have duplicated such training across the country. Their leadership in supporting clinicians, thereby supporting patients is priceless. Thank you!

Editor’s Note: The program is made possible through an unrestricted grant that CSL Behring gives to the Alliance every year. CSL has been funding this program for the last 20 years. We appreciate the visionary and generous support the program has enjoyed from them over the last two decades.

Alliance Update

Hemophilia Alliance Participation at Regional Meetings

2nd Annual North Carolina HTC Summit: Jeff Blake, SVP Payer Relations, recently attended the 2nd Annual North Carolina HTC Summit. Jeff presented a Hemophilia Alliance and Payer Update to attendees from three North Carolina HTCs, University of North Carolina, East Carolina University and Wake Forest University. Approximately 20 people were in attendance. The update included Hemophilia Alliance strategic activities, and regional and national payer relations efforts.

THSNA Lobby Day: Joe Pugliese plus sixteen other members of THSNA (the Thrombosis & Hemostasis Societies of North America) along with six ASH colleagues on the ASH Advocacy Committee, took part in the first ASH-THSNA Hill Day on June 7. The effort was led by Eric Grabowski, Immediate Past President of THSNA. In addition to Eric and Joe, Shannon Carpenter from Children’s Mercy and Peter Kouides from the Mary Gooley Center joined the effort. The day began with a briefing and discussion at ASH headquarters, and then we traveled to Capitol Hill in groups to meet with 25-30 different Congressional offices. Our primary mission was to advocate for stable and increased federal funding for research for both the NIH and the CDC. In that we were quite successful, insofar as there was near-unanimous support for our aim on the part of Congresspersons and/or their aides with whom we met. Moreover, this support was bipartisan.

The Hemophilia Alliance Team is very willing to attend and present at your State or Regional Meeting. Please contact Joe Pugliese at if you are interested in having a member of the Hemophilia Alliance Team attend and present at your meeting.

– – –

Updates about Alliance Meetings in 2017 and 2018
By Sean Singh

Fall Members Meeting 2017

With all the changes happening in Washington, DC, we will have lots to talk about together at the Fall Members meeting. It seems as though not a day goes by without some new information about healthcare. The next members meeting will be in San Diego, CA, on September 17-19, 2017.

We will be meeting at The US Grant Hotel, located at 326 Broadway, San Diego, CA , 92101. We have negotiated discounted rates for our room block: Superior Guestroom $239 or 1 Bedroom Legacy Suite $339. We encourage you to please make your reservations as soon as possible. If your plans change, you can always cancel the reservation. The cutoff date for our room block is August 18. To make reservations, please call 866-837-4270 (refer to the Hemophilia Alliance Room Block) or book online here.

Meeting for CPR+ Users after Member Meeting

The Hemophilia Alliance has been in discussion with Mediware about working with our member users. Mediware has agreed to San Diego and participate in a special session the morning after the Member Meeting (Wednesday, September 20th from 8:30 am to 11:30 am). A team of people will be coming to will listen to our concerns and see how they can make CPR+ work better for us.

Please email me at and let me know if you are able to attend the CPR+ session so we can plan accordingly. We have also been asked to prepare a top 15 list of issues to send in advance of the meeting. Please let me know if you have any specific questions or concerns.

Save the Dates for 2018

Please make a note and block your calendars for an exciting year of meetings in 2018:

– January 22-23 – Board Meeting
– March 18-20 – Spring Members Meeting
– September 23-25 – Fall Members Meeting

Information for the social workers meeting will be published in August 2017. The planning committee will be meeting during the summer to determine the dates of the meeting and the topic.

We are waiting for the congressional calendar to be published for 2018. Once we have that information we will announce the Hill Day visits which will be combined with a Physician-led meeting and an Introduction to 340B for new Alliance members and folks who want a refresher on the basics.

– – –

Team Alliance Contact Information

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

Joe Pugliese……215-439-7173
Sean Singh……727-388-7326
Jeff Blake……317-657-5913
Elizabeth Karan……202-466-8960
Roland Lamy……603-491-0853
Audra Ames……727-415-6397
Ellen Riker……202-484-1100
Johanna Gray……202 484-1100
George Oestreich……573-230-7075