March 2018 Newsletter

In this Issue…

Notes from Joe
· March Madness!

Washington Update
· Washington Update – we need YOU for the Alliance Hill Day!

Payer Update
· Medicaid Update
· Manufacturer Co-Pay Assistance: The Rules are Rapidly Changing

Notes from the Community
· NASTH 2018 Research Fellowship

Alliance Update
· Update on Alliance meetings
· Save the Date for 2018 Events!

Team Alliance Contact Information

Notes from Joe

March Madness!
By Joe Pugliese

“March is Bleeding Disorders Awareness Month,” which has been recognized by HHS as a National Health Observance since 2016. It formalizes and expands upon the designation 30 years ago of March 1986 as “Hemophilia Awareness Month” by President Ronald Reagan. It has been a remarkably busy month in the bleeding disorders community and it is still going!

The month started the 21st Annual Advanced Social Worker Workshop in San Antonio, TX. The workshop has been officially renamed the Linda Gammage Social Worker meeting, after the visionary social worker who years ago was able to convince a young(er) visionary then at CSL Behring to fund this unique educational event. Our sincere thanks to CSL Behring for being the corporate sponsor over all of these years.

The next stop was New York City for the Coalition for Hemophilia B Annual Meeting. The highlight of the evening was the awards ceremony. The recipients of this year’s Eternal Spirit Award were Laurie Kelley, who needs no introduction, and William Pataskos, PharmD, who among many other accomplishments was one of the first responders to bring supplies and assistance to the bleeding disorders community in Puerto Rico. We next visited the NHF offices to strategize with the Advocacy team on ways to ensure access for patients and HTCs in 2018 and beyond. Later in this newsletter, you will find a summary article from Kollet Koulianos, former Executive Director of Bleeding and Clotting Disorders Center in Peoria, Illinois and now Senior Director Payer Relations with NHF and national expert on accumulator adjustors.

The following week was even busier. The National Hemophilia Foundation held their annual Hill Day in Washington, DC. Nearly 500 participants were all adorned with some variation of red ties (the same ones we will wear in our Hill Day to show our support). This year, advocates focused on maintaining access to private insurance and Medicaid for our patient community. NHF advocates have also consistently asked Congress to maintain both the HRSA MCH/SPRANS funding as well as the CDC funding for HTC surveillance and hemophilia education. The big news this year is that there was also a specific ask for HTCs to maintain access to the 340B program. This generated a great deal of discussion in our Congressional visits, and it is clear to me that “fixing” the 340B Program is very much on the minds of many of the our Congressional representatives.

While the Hill visits were happening in DC, HTRS and THSNA were holding important biannual meetings in San Diego. Drs. Diane Nugent and Rodney Camire chaired the 2018 HTRS/NASTH Research Colloquium, which sought to generate discussion, awareness and excitement about the opportunities available to young researchers looking to pursue a career in benign hematology. The Hemophilia Alliance was a proud sponsor of the event. We were equally pleased to both display at and participate in the THSNA meeting. Our open session and our Alliance member-only dinner were well attended. Read on for a summary of the event.

The month will conclude with our member meeting in New Orleans on March 25-27th. We are setting records for attendance with 130 people signed up to date. If you are signed up already, we look forward to seeing you. If you have not signed up and would like to participate, please let us know. If not, I hope to see you in Washington on April 25-26 for our Physician Meeting, Member Meeting, and Hill Day.

Washington Update

By Johanna Gray

Here are the highlights of a busy few weeks in Washington:

President’s Budget: President Trump released his proposed budget for fiscal year 2019 in mid-February. The high-level budget documents released by the administration indicate that President Trump is calling for significant cuts to the parent centers/program at the CDC and HRSA that house the hemophilia grant activities. Since detailed budget information has not yet been released, it is difficult to tell whether the President is specifically recommending cuts to the hemophilia programs, but this remains very concerning. Luckily, Congress ultimately decides what funding levels agencies will receive, and we will continue to advocate to protect these programs.

340B Reform: Since the last Newsletter, another 340B bill has been introduced in Congress. Senator Chuck Grassley (R-IA) has introduced the Ensuring the Value of the 340B Program Act, which would require hospitals to include on their Medicare cost reports the total acquisition costs and revenues by payer for their 340B drugs. Senator Grassley argues that this level of transparency will allow Congress to evaluate whether the program is functioning appropriately. This bill would not apply to HTCs directly.

Additionally, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing, Perspectives on the 340B Drug Pricing Program, on March 15th. Participants included representatives from hospitals and community health centers on the covered entity side, as well as PhRMA to represent the drug industry. Many Senators expressed support for the 340B Program, but some asked pointed questions of the hospital industry about whether additional transparency is necessary to understand how much revenue hospitals are generating and how they are using those dollars. We anticipate that there may be another HELP hearing involving testimony from HRSA later this spring.

It is clear that Congressional interest in 340B is increasing, though hospitals remain the focus rather than grantees, or HTCs in particular. The Alliance policy team is closely monitoring all of this activity and continues to advocate on behalf of HTCs.

All this leads to the bottom line that we need YOU for the Alliance Hill Day!

It has never been more important time for HTCs to come to Washington to tell our stories! I’ve included the details below and hope that you will plan to join us in DC next month.

Agenda for the Event

Wednesday, April 25:

  • Physician-Led Meeting: 1:30-3:30 PM
  • Alliance Member Meeting and Hill Day Training: 5:30-7:30 PM

Thursday, April 26th:

  • Meetings on Capitol Hill in teams: 9:00 AM to 4:00 PM

Patient participation: Like last year, the Alliance is able to fund one HTC patient per center to come to Washington to join us on the Hill. This should be a patient who is enthusiastic about your HTC, is utilizing your 340B program and is willing to share his or her story. Please contact Sean Singh ( for more information about bringing a patient to DC.

Educating vs. Lobbying: Many HTCs have questions regarding whether and how they can advocate. Lobbying is often treated like a bad word. However, personnel at HTCs ARE allowed to participate in the Alliance Washington Days, since we will be educating Congressional members and staff rather than directly supporting or opposing a piece of legislation. Our visits focus on that educating Congress about the role of HTCs in providing comprehensive care for the bleeding disorders community and discussing how 340B program income enables that care, not lobbying, so you are safe to participate.

Registration link: See here.

Questions? Please contact Sean Singh ( with any logistical questions or Johanna Gray ( with any questions about participating in the Hill Day.

Payer Update

Medicaid Update
By George Oestreich

The deadline for the states to update their state plan amendments (SPAs) with CMS ended June 30, 2017 and there are still about a dozen states that have not completed that task. We are keeping track of all of the new SPAs and how they have handed clotting factor. CMS required that the states include their process for handling clotting factor in the SPA but CMS does not require the states to use actual acquisition cost and the standard dispensing fee for clotting factor.

Even though states have latitude to vary the definition of the cost of clotting factor and the dispensing fees, only a few have chosen to use that option. The states that have worked out specific reimbursement schedules and targeted dispensing fees are the ones that the HTC providers have developed relationships with the Medicaid agency. In those cases, better reimbursement solutions have been adopted.

If your state has not developed a “friendly” reimbursement methodology it is not too late. SPAs can be changed. The first step is to reach out to your Medicaid agency and begin a dialog with them so they may understand why you should receive a different reimbursement and collaborate with you to establish on. They may want to review your cost of dispensing report as well as your ceiling prices if you wish to use 340B. The Payer Team is glad to help you if you wish.

If your state is serving the hemophilia patients through a managed care company, there may be options to impact that reimbursement, as well. If you are not part of their network, we can often help with that, too. The MCO discussions are largely “one-off” discussions; each one is separate and different. Options include using the Alliance HANS network for the plan, single contract assignments, and encouraging the state to carve out the benefit for hemophilia patients back to fee-for-service.

Your Alliance team is also working with a consultant and several states to develop a disease management code that will allow HTCs to charge for the services that are not part of the dispensing function. This concept was included in the CMS letter sent to states last year. When developed this will give the HTCs an opportunity to be reimbursed for the clotting factor and directly related dispensing expenses AND disease management. Stay tuned and begin developing the relationships with your state Medicaid agency! Please contact us with any questions or concerns!

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Manufacturer Co-Pay Assistance: The Rules are Rapidly Changing
By Kollet Koulianos, Senior Director Payer Relations, National Hemophilia Foundation

Until recently, manufacturer copay assistance programs have been instrumental in helping our patient population ease the burden of high deductible and annual out-of-pocket (OOP) expenditures. Today, many are finding out the hard way about accumulator adjustment programs that are changing the rules. These programs, promoted by insurance brokers/consultants and PBMs as cost savings tools, are being rolled out by self-funded health plans and some exchange plans.

While these programs allow patients to continue to utilize manufacturer copay assistance to fund prescriptions until the maximum value of the copay program is reached, at that time, the PBM resets the member’s accumulator – their accumulated annual OOP expenditures such as copays, co-insurance and deductibles – to reflect only those contributions actually paid by the member. They believe that if the patient has more skin in the game, they will make “wiser” choices.

With the meteoric rise in healthcare costs, it’s no wonder U.S. employers are continuing to shift health care coverage expenses to their employees in response, to make them more accountable for their choices. These shifted costs are represented by an increase in high deductible health plans, a greater number of plans with co-insurance and higher out of pocket maximums; and now the accumulator adjustment programs.

As a result of all the cost shifting, chronic disease patients requiring high value (life and death) specialty drugs have become more and more dependent on manufacturer copay assistance programs to ease the burden of shifting costs to access their medications.

The accumulator programs also take aim at manufacturers, who they believe are using copay assistance to drive patients to higher cost drugs, as opposed to cheaper, generic equivalents; however, considering our community has no generic equivalent, this one size fits all approach is only becoming a roadblock to patient access.

In a large literature review that analyzed over 160 abstracts and publications on patient adherence trends with higher cost sharing, the conclusion was that increasing patient cost sharing had a direct correlation with decreased adherence. 1

Even the Pharmacy Benefit Management Institute conceded this point,2 “Plan sponsors must develop effective strategies beyond higher cost-sharing for managing specialty drug spend, given the detrimental effect that further copay increases for specialty drugs are likely to have on medication adherence.”

For those with rare diseases such as hemophilia, whose total cost of care exceeds the six figure (and higher) range annually, >85% of which is attributed to the prophylactic use of replacement clotting factors (specialty biologic drug therapies w no generic alternatives), non-adherence will almost always produce unintended consequences (i.e. increased ER visits, joint bleeds/damage, missed days’ work, etc.) 3,4 resulting in much higher costs to the payer than the perceived ‘savings’ from this cost sharing shift.

In conclusion, the National Hemophilia Foundation has been working to communicate the urgency for payers to consider the implications the accumulator adjustment programs will have on patients with chronic diseases that have no generic alternative available, which will be a net negative for all parties involved.

If you have any examples of patients who can no longer access their medications due these accumulator adjustment programs; including any avoidable ER visits or hospitalizations that resulted, please share those with me as soon as possible so we document them and use them to get employers to reconsider this strategy. I am more than happy to help answer any questions as well. I can be reached at 309.397.8431 or by email at


1 How Patient Cost-Sharing Trends Affect Adherence and Outcomes –

2 Pharmacy Benefit Management Institute 2012–2013 Prescription Drug Benefit Cost + Plan Design Report

3Tarantino MD, Ye X, Bergstrom F, Skorija K, Luo MP. The impact of the economic downturn and health care reform on treatment decisions for haemophilia A: patient caregiver and health care provider perspectives. Haemophilia. 2013;19(1):51-58. doi: 10.1111/hae.12008

4 Zhou ZY, Koerper MA, Johnson KA, et al. Burden of illness: direct and indirect costs among persons with hemophilia A in the United States. J Med Econ. 2015;18(6):457-465. doi: 10.3111/13696998.2015.1016228

Notes from the Community

NASTH 2018 Research Fellowship

NASTH, the North American Society on Thrombosis & Hemostasis, has released its application for its 2018 Research Fellowship. The goal of the fellowship is to introduce students to the field of hemostasis and thrombosis through targeted research projects, which may be lab-based, clinical or epidemiology research. First, second and third-year medical, PhD, and MD/PHD students are eligible to apply for the fellowship, which will provide a stipend for the fellow and his or her lab. NASTH is also seeking more experienced researchers to serve as mentors to fellows. More information is available here.

Alliance Update

Update on Alliance Meetings

We have brief updates on recent Alliance meetings:

Thrombosis & Hemostasis Societies of North America (THSNA) Summit

The Hemophilia Alliance showed up in full force at the Thrombosis & Hemostasis Societies of North America (THSNA) Summit earlier this month. The Alliance led a pre-conference workshop in which Sean Singh familiarized attendees with the Alliance, Elizabeth introduced the 340B Drug Discount Program and related proposals from Congress, and Jeff Blake discussed the common challenges facing Hemophilia Treatment Centers (HTCs) in the payer space. Approximately 25 people attended the pre-conference workshop with representatives from drug manufacturers, HTCs, and other providers. The Alliance also hosted a dinner for approximately 40 Alliance members attending the conference. At the dinner, Alliance staff and consultants briefly reprised the conference workshop and facilitated a productive dialogue on payer issues and other challenges facing HTCs. The Alliance appreciated participating in the THSNA Summit and connecting with member HTCs.

Chapter Meetings

We have been getting a good response to our newsletter being shared with you. We have also been getting a lot of invitations to participate at Chapter meetings across the country. We appreciate the invitations and are looking forward to being a part of your meeting and discussing the issues that are affecting our community. As we work together we know we will be better positioned to help patients and providers in the community. If you have any further questions about getting us to your meeting, please feel free to reach out to us.

On that note, you don’t just have to take our word for it that our participation in your chapter meeting could be useful. See this note from Jill Packard, the Executive Director of Hemophilia Alliance of Maine:

Having the Hemophilia Alliance and Sean Singh present at our Annual Meeting helped our members understand how the 340b works and its role within our community. Comprehensive care remains an important part of our community's future and we should all educate ourselves about issues related to quality of life.

Save the Date for 2018 Events!

Save the date for Alliance events in 2018, including:

  • March 25-27: Alliance Members Meeting in New Orleans, LA – Register Here
  • April 25-26: Physician Meeting and Alliance Hill Day in Washington, DC – Register Here
  • September 23-25: Physician Meeting and Alliance Members Meeting in Las Vegas – Register Here

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 215-439-7173
Sean Singh 727-388-7326
Jeff Blake 317-657-5913
Jeff Amond 608-206-3132
Johanna Gray, MPA 703-304-8111
Elizabeth Karan 612-202-3240
Kimberly Wolverton Lackman 813-400-6710
Roland P. Lamy, Jr. 603-491-0853
Dr. George L. Oestrich, Pharm.D., MPA 573-230-7075
Ellen Riker 202-257-6670
Mark Plencner 701-318-2910
Michael B. Glomb 202-466-8960
Theresa Parker 727-688-2568
Karen Bowe 717-571-0266
Joel Bellucci 727-504-0491