August 2019 Newsletter

In this Issue…

Notes from Joe
· The More Things Change…

Alliance Update
· We are Growing!
· Save the Date for an Alliance Session at the ASH Meeting on Making the Running of an HTC Tolerable

Legal Update
· Factor Loans During Emergencies: Truth and Fiction

Operations Update
· Reminder: Sharing HTC Information: Caution is the Best Policy
· Save the Date for an Alliance Session at the ASH Meeting on Making the Running of an HTC Tolerable

Washington Update

Payer Update

Team Alliance Contact Information

Notes from Joe

The More Things Change . . .
By Joe Pugliese

Over the last several months I have routinely spoken about the need for HTCs and their local chapters to find ways to work together or most often to work together more effectively and efficiently. Last month I specifically spoke about the need to collaborate with all stakeholders in the community.

I have just spent two days in Boston at a meeting highlighting advancements in therapy that are on the cusp of coming to the bleeding disorders community. Seemingly everyone is working on a gene therapy solution for hemophilia, and it seems likely though not certain that the first gene therapy option for hemophilia will be approved next year. There are likely to be several additional gene therapy options in the next few years. There are a host of other treatment options in various stages of clinical trials and product development that offer effective, novel, and convenient treatment options. These products include subcutaneous FVIII and FIX, RNA interference technology and even an implantable delivery model. All of these therapies are on top of the extended half products and the recently introduced rebalancing therapy that has offered a degree of convenience coupled with an excellent and previously unattainable annual bleed rate. There is already a similar type of therapy on its way to being approved.

Collectively all of these advancements promise to dramatically improve the lives of people with bleeding disorders. They are also likely to dramatically change our community. While none of the products referenced above offer a cure, they do promise to dramatically change the way people with hemophilia will see themselves. It will also change the broader community of stakeholders and how those stakeholders see themselves and others in the community.

As if these changes were not dramatic enough, now we also have the departures of the long time CEOs of both the National Hemophilia Foundation and the Hemophilia Federation of America, who have each led these respective organizations for the last decade. Val Bias is retiring at the end of the year and Kimberly Haugstad has already started her new adventure as the CEO of Global Genes. I would be remiss if I did not thank both of them for the outstanding job they have both done in leading their respective organizations and their tireless and incredibly effective work representing the bleeding disorders community.

During this time of change, it is clear that HTCs, the national organizations, chapters and individuals and families are all uncertain about what the future may bring and how we can collectively work together to ensure the brightest possible future for everyone in our community.  One of the charms of the bleeding disorders community is that in a room with 10 people, there will be 20 different opinions and they are all correct.  I would encourage all stakeholders to remember one simple adage: first do no harm.

Alliance Update

We are Growing!

You might have heard how the Alliance membership, services offered to members, and payer contract offers are all growing. So, we are growing our team as well.

Due to all of this growth, we felt the time was right to implement a newly created position to the Alliance: Director of Community Relations. Karen Bowe, MBA, MT, is excited to join our team and work with our centers in the northeast. Before joining the Hemophilia Alliance, Karen was employed as a Coagulation Specialist with Octapharma and was responsible for hemophilia product sales in Northeastern US. Prior to her tenure with Octapharma, she worked with several Specialty Pharmacies, most notably as an Area Vice President with Accredo, and was responsible for the Community Affairs Division for 13 years. Prior to that, she managed the Specialty Hematology laboratory at the Hershey Medical Center/Hemophilia Treatment Center for 15 years. Karen received her undergraduate degree in Medical Technology from Pennsylvania State University and her MBA in Health Care Administration from Eastern University. She currently resides in Harrisburg, PA.

We are pleased to introduce our new Administrator, Theresa Parker. Theresa brings a dynamic combination of strong technical skills as a programmer and designer and she has experience with SQL databases. Theresa has a degree in design from Savannah College of Art and Design. She is returning to the workforce after spending time raising her twin sons who are now in middle school. Theresa is excited about getting back in the corporate world, as she had to leave her last job unexpectedly because her boys showed up a bit early. She said she chose to work at the Alliance because of the close knit relationships we form and because we live up to the promise of reinvesting in the community. She looks forward to meeting all of our members at the fall meeting in Portland, Oregon.

The talent that we now have will multiply the dividends that our members get. Aristotle coined the phrase “The Whole is Greater than the Sum of its Parts” and we believe that the Alliance team is representative of that statement.

Legal Update

Factor Loans During Emergencies: Truth and Fiction
By Elizabeth “Issie” Karan

Hemophilia Treatment Centers (HTCs) sometimes must help patients in emergency situations obtain factor. When patients show up in the emergency department or have an unexpected medical event, HTCs prioritize patient well-being over everything else (as they should). However, HTCs should try to mitigate compliance risk as much as possible and utilize best practices if a short-term loan is necessary to keep patients stable.

HTCs which loan factor to another entity may face findings of diversion and/or obligations to repay manufacturers’ discounts under the 340B Discount Drug Program. Depending on how policies and procedures define “material” breaches, HTCs also may be obligated to make a self-disclosure to HRSA. Loans to entities which are not eligible for 340B likely violate the statutory requirement that all covered drugs purchased under the 340B Program be provided only to patients of the covered entity. However, even the provision of 340B-purchased factor to another covered entity, which is eligible for the 340B program, creates risk.

No specific guidance exists in the 340B Program regarding the sharing of inventory among covered entities during emergency situations. However, FAQ 1197 on the Apexus website indicates that a single organization with multiple, unique 340B IDs should not transfer 340B-purchased drugs among those IDs, given that their patient populations and scopes of project may differ. However, the same FAQ states that HRSA may consider approving an inventory sharing/transfer agreement between unique 340B IDs on a case-by-case basis.

In informal technical assistance conversations, Apexus explained that the appropriate approach to loaning 340B-purchased inventory varies by: (1) the status of 340B eligibility for each entity; (2) the type of covered entities involved; and (3) the inventory model utilized by each entity (i.e. virtual versus physical). For example, if one covered entity maintains neutral, virtual inventory, then a loan of 340B-purchased product, which is replaced with inventory purchased at WAC with the same NDC and within a 72-hour timeframe, may be allowable. Apexus also indicated that strong policies and procedures on this topic are advisable. Finally, HTCs may wish to consider if contract pharmacy partners also could help provide rapid response to emergency factor needs.

If your HTC wishes to be able to lend factor in emergency situations, please contact us and/or Apexus for help understanding the compliance challenges and the best ways to codify the process in policies and procedures.

Operations Update

Reminder: Sharing HTC Information: Caution is the Best Policy
By Jacqueline Lamb, Indiana Hemophilia and Thrombosis Center

An astute HTC staff member recently received a phone call from a third party requesting information about an HTC program. The caller positioned themselves as a student writing a school paper with questions asking for specific numbers of providers, about specific procedures, and for information about the pharmacy.

Rather than answer right away, the staff member asked the caller to send an email with their detailed questions. This gave the HTC enough time and information to verify the legitimacy of the request. Once received, a simple Google search of the caller’s email address, name and phone number showed that this was not a student, but instead a pharma/biotech consultant.

As a treating physician told their HTC staff previously, “What may seem like an innocuous question about patient care is often not so innocent. Many companies are trying to obtain information about how we view (a product), how we approach our patient population and how it will affect our ordering. This is not information that I feel comfortable sharing with companies.”

Please be careful not to discuss your center's use of any particular product or service with individuals outside of your center without proper consideration.

Save the Date for an Alliance Session at the ASH Meeting on Making the Running of an HTC Tolerable

As you prepare for the ASH annual meeting this December, we hope you add one of our sessions to your calendar. This year our topic will be “Making the Running of an HTC Tolerable.”

We will offer several sessions in the morning with breakfast and in the evening with dinner. Our sessions will be interactive where we will discuss HTC operations, payer initiatives and a look at the 340B program in 2020 and beyond. The breakout sessions will be hosted by Joe Pugliese, President and CEO, Sean Singh, SVP of Marketing and Operations and Jeff Blake, SVP of Payer Relations.

If you are unable to make one of our team sessions, we can accommodate you on an individual basis.

If there are any topics or specific issues you would like for us to discuss, please contact Joe at Joe@hemoalliance.org.

Washington Update

Washington Update
By Johanna Gray

I’m writing today with two updates on issues that we’ve discussed in prior Newsletters and emails:

Skilled Nursing Facilities Update: In August, the Centers for Medicare and Medicaid Services released the final Skilled Nursing Facility (SNF) payment rule for 2020. In the final rule (available here), the Agency responded to the request made by the Hemophilia Alliance and NHF for hemophilia treatments to be able to be billed separately by saying that it does not have discretion to add new categories of treatments to the excluded categories. Here is the relevant section:

Comment: Commenters urged CMS to create an exclusion from consolidated billing for clotting factor and non-factor medication therapies for patients with hemophilia, similar to the existing exclusions for chemotherapy and its administration, radioisotope services, and certain customized prosthetic devices.

Response: We note that the item/ service categories cited by the commenters (chemotherapy and its administration, radioisotope services, and certain customized prosthetic devices) are in statute at section 1888(e)(2)(A)(iii) of the Act (as enacted through section 103 of the BBRA). As we indicated previously in the FY 2012 SNF PPS final rule (76 FR 48531), hemophilia treatments are outside the particular service categories that the statute authorizes for exclusion, and establishing an exclusion category for hemophilia treatment services, or any other service categories that are not specified in the statute, would require legislation by Congress to amend this statutory provision. Thus, we decline to adopt the commenter’s suggestion.

This was the expected response, which is why we continue our advocacy with Congress and hope to have legislation to address this issue introduced this fall. We’ll provide an update to the membership at the meeting in Portland in September.

Essential Community Providers Database: As Joe emailed to the membership a few weeks ago, it is time once again for HTCs to verify their listings in the HHS Essential Community Providers (ECPs) database. The Affordable Care Act (ACA) designates HTCs, along with all 340B covered entities, as essential community providers (ECPs) and requires that marketplace plans include a certain number in their networks. To implement this policy, several years ago, HHS created a database to facilitate plans’ ability to identify and contract with ECPs in their service areas. Contracting with a provider in the ECP database allows insurance plans to get “credit” for including the ECP in its network.

Due to technical issues with the ECP website, HHS has extended the deadline for covered entities to update their listings to August 31, 2019. If you haven’t already, please check to make sure that your center’s information is correct (for those already listed) or complete the form to be added to the database. There are more than 120 HTCs (and/or their parent institutions) who are listed in the database already, but it is important to make sure that the information is correct. We have heard from a few HTCs that they have been contacted by plans and ultimately got contracts because of the database. While changes can be made on a rolling basis, we encourage you to review your listing before August 31, 2019 so that any changes will take effect for the 2021 plan year.

You can complete the form here: https://data.healthcare.gov/cciio/ecp_petition. More information is available there and feel free to contact me (jgray@dc-crd.com) with any questions, as well.

Payer Update

Payer Relations Update
By Jeff Amond

Do you remember this article from last year?

Too much work and too little time. That is how I felt most every day when I worked at an HTC. That feeling is all too common for many HTC’s across the country. As a Social Worker/Insurance Specialist at my former HTC, most of my time was spent helping our current clotting factor pharmacy patients with their insurance and financial issues. When we lost a clotting factor patient to a specialty pharmacy, I just didn’t have the time nor the resources to take on that fight. The good news for all of you out there who also struggle with this problem is that myself along with the rest of the Hemophilia Alliance Team have the time and the resources to help. Let us help you win back the clotting factor business to your center. Let us help with your insurance issues. We are only a phone call or email away.

The great news is that more and more HTCs have followed up on this request. In addition, more and more HTCs are setting up a standing call (monthly, quarterly) with their payer team contact to address ongoing issues and/or to alert us to new ones. We are showing good success for those HTCs that have reached out to us, but what does SUCCESS really mean. I looked to the definition of success for answers. Part of the definition of success states “a favorable or desired outcome”.

Was it a favorable or desired outcome when the Hemophilia Alliance Team was able to get an HTC contracted as an in-network provider? Was it a favorable or desired outcome for an HTC when the Hemophilia Alliance Team was able to win back the pharmacy business for a patient they had lost to a specialty pharmacy? Was it a favorable or desired outcome for an HTC when the Hemophilia Alliance Team was able help them retain the pharmacy business for a patient? The answer to all these questions is YES. We are having SUCCESS and we can have SUCCESS for you.

Here’s what one HTC reported about a success story from working with the Hemophilia Alliance:

Thank you to the Hemophilia Alliance Network Services (HANS) team for our recent success in adding a self-funded employer health plan to our factor program. The Center was only aware of the opportunity through HANS’ work with insurance brokers. Working with Jeff A. was a pleasure as he thoroughly managed the process from start to finish. He made it very easy for us. Price points were discussed, a letter of agreement was presented, and assistance is being provided with transitioning the patient to our center’s pharmacy. We are certain that the insurance broker has taken notice of the positive outcomes for the health plan and our center and believe that HANS is now on their radar for additional collaborations.

Please contact the Hemophilia Alliance Team to learn how we can assist your HTC in winning back the business.


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
Johanna Gray, MPA jgray@dc-crd.com 202-484-1100
Elizabeth Karan ekaran@feldsmantucker.com 202-466-8960
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@dc-crd.com 202-484-1100
Mark Plencner mark@hemoalliance.org 701-318-2910
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Theresa Parker theresa@hemoalliance.org
Karen Bowe
Joel Bellucci webmaster@hemoalliance.org 727-504-0491