Hill Day 2020 Newsletter

In this Issue…

Notes from Joe
· Advocacy Matters!

Legal Update
· 340B Program Attacks: What You Need to Know and How to Respond

Washington Update

Payer Update
· HANS PPO Agreement: 32 signed, 75 to go!

Alliance Update

Notes from the Community
· Hemophilia Alliance Foundation Offers Additional Grant Opportunities for COVID-19 Patient Assistance

Team Alliance Contact Information

Notes from Joe

Advocacy Matters!
By Joe Pugliese

I’m writing this as we’ve just concluded our first-ever virtual Hill Day.  First, I want to thank the 60+ participants, who included representatives from Alliance member HTCs, chapters, NHF and HFA, and individual patient advocates.  We held more than 80 meetings with Congressional offices, where we educated staff about bleeding disorders, the importance of the HTC network, and asked for co-sponsors for the Hemophilia SNF Access Act (S. 3233 / H.R. 5952). We had a great reception on all of these issues, and have already added several new co-sponsors to the bills.  Shout-out to Team Alaska (John Palmatier and Matt Findley), Team Illinois (Heather Alvarez and Kimberly Casara), Team New York (Renee Czarniak, Laurie Reger, and Nathan Schaefer) and Team Wisconsin (Erica Brock, Stephanie Lovell, Jessie Pindilli and Ralph Woods), for successful advocacy with Sens. Murkowski and Gillibrand and Reps. Davis, Pocan and Rush. I’m confident we’ll add additional co-sponsors in the coming weeks.    

Our advocacy this week reminds me of a few things worth remembering.  One, is that despite everything else consuming the attention of policymakers these days, it is still very important that we continue to advocate on issues that matter to us.  No one but the bleeding disorders community can advocate for our SNF bill, for example, or for our continued access to 340B.  Two and relatedly, we also continue to experience lots of challenges to ensure access to high-quality care for our patient community.  None of these issues are helped by COVID, and some are exacerbated, as people lose their insurance coverage and need help finding new plans. We also continue to face challenges to our participation in the 340B program, some of which are explained in more detail in Issie’s article below.  This makes our continued advocacy even more important. 

When the Sanofi letter noted below came out on July 27th, we were immediately in contact with the company.  They have assured us their new policy does not apply hemophilia treatment centers. This message is very consistent with the long-standing support we have had from our manufacturing partners. We thank Sanofi this assurance and we are reaching out to all of our contract partners asking for the same assurance. Lack of access to 340B pricing through contract pharmacy providers would eliminate greater than 90% of the revenue for a significant number of HTCs across the country. Obviously, this would have a negative impact on patient care. 

Finally, I’m reminded again that our patients, providers and chapter and national organization partners make incredibly effective advocates.  This makes me confident that we can respond to our challenges. We face plenty of challenges, and undoubtedly other unexpected issues are lurking around the corner.  But I’m confident that together, we’ll be able to respond together to protect our patients’ access to the high-quality care provided by HTCs.  If you would like to join us in advocating on the Hill, or in any other setting, please let me know.  We’d be glad to have you join us!

Legal Update

340B Program Attacks: What You Need to Know and How to Respond
By Elizabeth 'Issie' Karan and Mike Glomb

In recent weeks, three drug manufacturers have taken unprecedented actions that threaten covered entity participation in the 340B Discount Drug Pricing Program (340B Program). Although narrowly tailored, these announcements represent a new boldness from 340B Program opponents. Each drug manufacturers’ actions are slightly different, but all create significant concerns for covered entities and their patients. 

First, this week Sanofi began contacting covered entities listed in the 340B database and requesting submission of all claims of their products dispensed through contract pharmacies. In the FAQ section of Sanofi’s communication, Sanofi stated that if a covered entity does not provide this claims data that the covered entity will no longer be eligible to place “bill to/ship” to replenishment orders for Sanofi products dispensed through contract pharmacy. Second, and somewhat similar to Sanofi’s request, earlier this month Merck sent letters to seemingly every covered entity in the 340B Program database, requesting submission of all 340B contract pharmacy claims data on Merck products. Sanofi and Merck are utilizing the same vendor to compile submissions, 340 ESP. Finally, effective July 1, 2020, Eli Lilly announced on the Office of Pharmacy Affairs (OPA) website that it will only provide certain formulations of Cialis directly to covered entities, stating “Contract pharmacies will not be eligible to receive these formulations of Cialis at the 340B ceiling price.” 

The actions of these manufacturers are disturbing and not fully supported by law. The 340B Statute allows the government and manufacturers to audit covered entities when they are “…(acting in accordance with procedures established by the Secretary relating to the number, duration, and scope of audits) … that directly pertain to the entity’s compliance with…” with prohibitions on duplicate discounts and diversion. (See Section 340B(a)(5)(C) of the Public Health Service Act). In short, manufacturers must make a “good faith” request for information based on credible allegations of non-compliance. OPA usually supports a manufacturer’s request for information but we do not believe that Sanofi or Merck’s approach meets the requirements of the 340B Statute or a “good faith” inquiry, given the breadth of distribution and the absence of any details. However, as recently as July 21, 2020, Admiral Pedley, who oversees the 340B Program, stated that OPA does not have authority to regulate contract pharmacies. While this is highly debatable, the fact remains that HRSA has chosen not to intervene on behalf of covered entities. 

Given access to treatment concerns for bleeding and clotting disorder patients, we do not recommend completely ignoring these manufacturer requests. However, any response must be carefully crafted to account for future developments and covered entity obligations related to 340B Program compliance. As such, we strongly encourage you to contact the Hemophilia Alliance if you are impacted as we can provide additional background and resources.

Both the Hemophilia Alliance and the 340B Coalition are responding rapidly to these developments by raising awareness with federal policymakers, members, and stakeholders, and considering additional actions. We take the activities of these manufacturers very seriously as they threaten hemophilia treatment centers’ ability to serve their patients. We would appreciate hearing from members about these issues as our ability to help protect the 340B Program depends on knowing what is happening in the field.

Please contact us with additional questions or concerns.

Washington Update

By Johanna Gray

It’s been a very busy month in DC, even separate from our Hill Day!  Here’s what we’ve been tracking: 

Public Health Emergency:  On July 25th, HHS Secretary Alex Azar extended the COVID public health emergency for up to an additional 90 days.  This means that the Medicare waivers related to telehealth and other reimbursement policies will continue at least into the fall.  Depending on where the country is related to COVID at the end of October, the public health emergency may be extended again.  We will keep you posted.     

Trump Administration Drug Pricing Executive Orders: Last week, President Trump released 3 executive orders (EO) and mentioned a 4th that he may sign later this summer.  All of these EOs call for policies that would have to be implemented via regulation or guidance, so there should be opportunities to comment on them before they are implemented.  Here are links to each EO with a brief summary of each from our initial review: 

  1. Executive Order on Access to Affordable Life-saving Medications: This EO requires community health centers (CHCs) to price insulin and Epipens at 340B pricing (or actual acquisition, which may be only a penny) for low-income, or underinsured and uninsured people.  Enforcement would come from making it a component of their grant program.  The CHCs are very concerned about this proposal, since it would significantly reduce their program income, and they have existing sliding scale fee programs to reduce costs for low-income patients.
     
  2. Executive Order on Increasing Drug Importation to Lower Prices for American Patients: This EO is trying to promote importation of some drugs from Canada, including insulin.
     
  3. Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen: This directs HHS to finalize rulemaking that would require rebates in Medicare Part D to be passed onto patients, or else they would be found to be kickbacks.  
     
  4. Implementing the International Pricing Index: The final EO was mentioned by President Trump but has not yet been released. This would promulgate the International Pricing Index policy first proposed in 2018 that would tie drug prices for Medicare Part B drugs to the prices paid in other countries.  President Trump has indicated that he will release this EO if he is not able to successfully negotiate with the pharmaceutical industry to lower prices directly.  More to come on this!

Congress Working on 5th COVID Package:  Finally, Congress has been negotiating its next large COVID package.  This week, Senate Republicans released 8 different bills that they would combine to make up the Health, Economic Assistance, Liability Protection and Schools (HEALS) Act.  Of note to Alliance members, the HEALS Act would extend current policies related to telehealth through the end of the 2020, or the end of the public health emergency, whichever comes later.  As of this writing, Senate Republicans, House Democrats and the White House have yet to reach agreement on what should be included in this next package, though there is pressure on them to act due to expiring unemployment insurance provisions from prior bills and the continued effects of COVID throughout the country.  Congress is hoping to pass a bill in the next few weeks before its August recess, but the different sides are far apart for now.  We will update you as the debate progresses.

Payer Update

HANS PPO Agreement: 32 signed, 75 to go! 
By Jeff Blake

As many of you know we have been working the last 12 months to develop and implement the Hemophilia Alliance Network Services (HANS) HTC PPO Network.  We now have 32 signed PPO agreements with our HTC members, and we are working with several other members who are running the agreement through their process.  Imagine if all our member HTCs signed the agreement: we could offer the very best network of HTCs to payers.  Our payer team has made an initial outreach to every HTC and we will continue to follow up; at this exciting time, please consider participation so we may continue to bring new volume to your center.

We now have 3 HANS agreements with payers that are opportunities for members who have signed up to be part of the PPO Network.  These agreements have brought back millions of units to participating HTCs pharmacy programs, which has strengthened their sustainability.  We are working on more than 40 additional payer opportunities right now, which we hope will also develop into opportunities for our members.  As we continue to work with HTCs on the PPO Agreement, we have received several common questions comments about the HANS PPO Agreement, which are addressed below.  

A couple members were concerned that HANS will compete with their current payer contracts.  I will be clear: HANS has no interest in competing with your current payer contracts; our only goal is to help members increase their pharmacy business to support their HTCs.  By requiring data at the beginning of negotiations, we are able to minimize any conflicts with existing HTC agreements.  We seek to bring new volume to your HTCs, helping to capture dispensations to patients you may already treat clinically.  To provide a recent example: a regional payer asked HANS to respond to a Request for Proposal (RFP) for bleeding disorders pharmacy services.  During our discussions, we learned that the payer had also contacted individual HTCs in the region about the RFP.  We asked if the payer preferred to pursue one contract with HANS or to work with their local HTCs directly.  This payer wanted to work directly with the HTCs, so we dropped out and notified the HTCs that HANS can support their efforts.  We also told the regional payer that HANS can support any situations if they have a covered member located out of their region.  Hopefully, this recent situation highlights our efforts to support our members and not compete with current payer contracts. 

We have also heard concerns that the HANS PPO minimum rate structure is lower than the HTC’s usual and customary rates.  These rates are included to create a baseline for the lowest possible rate HANS would agree with a payer.  To date, all our payer agreements and individual Letters of Agreements (LOAs) have been above the HANS minimum rate structure.  Also, we continue to review market conditions to monitor the minimum rate structure and will amend the minimum rates, as necessary.

We recently received positive comments about the opt-in provision in the HANS PPO Agreement.  Several HTCs like this feature, since HTCs are not required to participate in a HANS Payer Agreement, but rather can review the terms of any opportunity and determine if they want to participate.

The Hemophilia Alliance Team is excited about our efforts with payers to support our members and we look forward to working with more member HTCs to expand our HANS efforts to help you grow your pharmacy business to support your HTCs operations and programs.

Please contact a member of the Hemophilia Alliance Team to learn more about HANS or how we can assist in solving your payer issues.

Alliance Update

By Sean Singh

I’m happy to provide quick updates about a number of Alliance activities this summer and fall.  As always, remember WE WORK FOR YOU and please contact me with any ideas or concerns.  

Summer Webinar Series

We hope that you will join us for the last summer installment of our popular webinar series.  We continue to look at solutions for every aspect of your program from manufacturers issues to helping you with payors to providing updates from our team in Washington DC about changes that might affect you from a legal or regulatory perspective.  We encourage you to let us know what might be affecting you and how we can help.  Our last summer webinar will be on August 20th.  

Fall Members Meeting and New HTC Staff Meeting

Due to uncertainty over the COVID situation this fall, the Alliance has made the sad but necessary decision to cancel the fall members meeting and the new HTC staff meeting.  We look forward to seeing everyone in person in 2021 and virtually via webinars this year.  

Virtual Meetings

We will be participating in both NHF and HFA annual meetings virtually.  We are looking for ways to support our members and to help tell their story at the meetings.  This can include stories about your center and the work you have been doing, or how you are preparing for the future.  The meetings are rapidly approaching.  If you are interested in helping us share your story, please contact Sean Singh at sean@hemoalliance.org.  

Website Additions

Recorded Webinars – We have been recording our webinars this spring and you can find the slides and recordings in the member section of the website. The summer series is also being uploaded to the website.  Please let us know if you are unable to access these presentations. The webinars are the proprietary and are for Alliance members only. 

Contact Form – A new Center Contact Update form has been added to the www.hemoalliance.org website.  The form is a way for you to update us on changes to personnel within your HTC at your convenience.  The form is located in the members section of our website.  Once you have logged in, click on the Alliance Members tab, then select Center Contact Update.

Email Notification – An email notification recently went out regarding entering in your purchase data.  In an effort to help you, help us we will send out reminder emails on the 1st, 6th and 9th of the month.  If you did not receive a reminder email and you are the person entering data, please contact theresa@hemoalliance.org

Primary Contact Map – A Contact Map has just been added.  You can find it under Alliance Members/Alliance Contact Map.  This will show you what team member is your main person of contact for your center.

Notes from the Community

Hemophilia Alliance Foundation Offers Additional Grant Opportunities for COVID-19 Patient Assistance
By Grant Hiura, Hemophilia Alliance Foundation Board

It is with great pleasure that the Hemophilia Alliance Foundation Board is able to offer an additional round of applications for COVID-19 Relief for Patient Assistance. We understand the challenges you are facing as service organizations are significant and we hope that these funds are helpful to our constituencies. The first round of applications awarded $336,500 to 50 organizations.
 
For this second round of funding, organizations may apply for up to an additional $3,500. You are welcome to apply for all or part of this amount. Please copy and paste the fields below into an email to me at grant.hiura@hemophiliaalliancefoundation.org and that will comprise your full application. The contact person must be the same primary contact as listed in your initial application.
 
If you did not apply for the first round of funding, please access the online application on the Hemophilia Alliance Foundation website to submit your application, as we will need additional documentation.
 
If you have additional questions or concerns, please email me at grant.hiura@hemophiliaalliancefoundation.org.  Or, email me with the requisite information completed below.

– –

(Please copy and paste the text below into an email to me at grant.hiura@hemophiliaalliancefoundation.org to apply for a second COVID-19 Relief Grant.)

COVID-19 Relief Application for Patient Assistance – Round 2

Name of organization:

Address:

City/State/Zip:

Contact Person:

Email of contact person:

Phone # of contact person:

Amount ($) of 1st round grant distributed to date:

# of families receiving assistance from 1st grant distribution:

Amount ($) of 2nd round funding requested:


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@artemispolicygroup.com 703-304-8111
Elizabeth Karan ekaran@feldsmantucker.com 612-202-3240
Kimberly Wolverton 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
Karen Bowe karen@hemoalliance.org 717-571-0266
Joel Bellucci webmaster@hemoalliance.org 727-504-0491