December 2019 Newsletter

In this Issue…

Notes from Joe
· 2019 Recap

Payer Update

Washington Update

Legal Update
· Legal Team Update – New Contact Information
· Foundations for Grant Compliance: Rules Exist Even When Ignored

Notes from the Community
· Emergency Guides Available
· 2020 Thrombosis and Hemostasis Summit of North America (THSNA)
  Abstract Submission Open

Alliance Update
· Reminder: 2020 340B Program HRSA Grantee Recertification Period
  Begins in January
· Operations Update
· 2020 Meeting Schedule

Team Alliance Contact Information

Notes from Joe

2019 Recap
By Joe Pugliese

Year end is the perfect time to stop and reflect on all the good fortune and the good things you have accomplished in the year soon to end. January will be soon enough to think about everything yet to accomplish; in fact, early in 2020 the Alliance board gets together to review the progress we had in 2019 and make sure our priorities for 2020 and beyond reflect our best thinking about what we need to do next. We invite each of you weigh in on what we should be doing next. It is fun to think about how you would like to shape the future in our little world. As mentioned here and everywhere, the pace of change and innovation has never been more dramatic. We will share our vision of what that world should look like, in January and throughout 2020.

To recap the year by the numbers:

  1. For the first time ever the Alliance is providing direct financial support for a startup HTC. The no interest loan is allowing the Alaska Bleeding Disorders Center ensure that people the bleeding disorders community in Alaska have a federally-supported hemophilia treatment center.
  2. We had 9 new participating members in 2019, which is particularly remarkable when you consider the constantly dwindling number of centers eligible. We now have 105 participating members out a possible pool of 112 HTCs who have factor programs. Our goal of course is to have all federally-supported centers be participating members of the Alliance and to assist the 25 centers without a factor program to start one.
  3. We celebrated 20 years of Hemophilia Alliance by inviting the 7 founding centers to our Fall Member meeting in Portland, Oregon. The fall meeting set a record for attendance with 140 participants.
  4. Some numbers: The final numbers are not in, but I think it is safe to say members saved around $100,000,000 on purchases again in 2019. Plus, our support for the community since 2009 has topped $16,000,000. I promise to work to grow both numbers in 2020.
  5. The Alliance Pharmacy (TAP) celebrated 10 years of supporting the HTCs and the community. Like the Alliance, TAP has a long history of giving back to the community. TAP was created specifically to support HTCs and the bleeding disorders community across the country. Since 2012, TAP has donated in excess of $1,000,000 back to the community. I have been able to confirm that TAP has provided more financial support to ATHN than all the big specialty pharmacies, PBMs and drug distributors in the country combined.
  6. TAP along with the Center for Inherited Bleeding Disorders (CIBD) are the exclusive distributors of record for the Alliance GPO contracts with Aptevo, Genentech, Kedrion, and Octapharma. Your support of our in-house distribution model saves you money and allows TAP to reinvest in the community. It also supports our efforts to contract on your behalf through the Hemophilia Alliance Network Services (HANS).
  7. We had 10 applicants for a single board position on the Alliance board. The applicants were uniformly outstanding and came from all corners of the treatment center community, including physicians, nurses, pharmacists, administrators, and social workers. We cannot thank everyone enough for offering their time and expertise to make Alliance an even better member organization. The bad thing about this is we could not say yes to all of them. We are delighted to have Regina Butler join us.
  8. We have three new board members on The Alliance Pharmacy Board: Amit Soni MD, John Myers RPh and Jeff Blake. We are seeking one additional board member for the pharmacy. If you are interested, please contact the head of the nominations committee, Stephanie Gustafson, RPh at Stephanie.Gustafson@uth.TMC.edu.
  9. The Hemophilia Alliance Foundation, chaired by Susan Karp, added several new board members in 2019, including Donnie Akers, Grant Huira, Maria Manahan, and Amy Marquez. The 2020 grant guidance was posted on the Foundation website on December 5th. Applications are due back not later than January 31st, 2020. There will be a record amount of grant money available in 2020.
  10. Looking ahead to 2020, The Alliance Board has approved us to add an additional team member who will give us the ability to help members with billing and enhance our payer marketing efforts. This position will be located in the Tampa, FL area. Initially this support will be directly related to our HANS and PPO initiatives and like all Alliance services (GPO, Operations, Advocacy, Legal, and Payer Contracting) will be available at no additional cost, beyond your very modest annual membership dues. A job description is available here.

Merry Christmas and Happy New Year! May 2020 be a happy and healthy year for all of you.

PS. Reminder: The 2020 340B Program HRSA Grantee Recertification Period Begins in January. See later in the newsletter for the note from HRSA with details about the 2020 recertification process.

Payer Update

Patient Data: Who Owns It, How Do You Use It, and Why Should You Care?
By Jeff Blake

This has been a very busy year for the Hemophilia Alliance Payer Team, with our primary focus on enhancing awareness of our hemophilia treatment center members with payers and the rollout of the Hemophilia Alliance Network Services (HANS) PPO Agreement.

The payer contracting space is getting more competitive and difficult to manage. We are seeing more payers and insurance companies narrowing their networks for dispensing bleeding disorder products. Most recently, Highmark Blue Cross Blue Shield and Regence Blue Cross Blue Shield announced very narrow networks for dispensing bleeding disorder products and Anthem Blue Cross Blue Shield rolled out their own pharmacy benefit manager, Ingenio Rx. We see these trends continuing in bleeding disorder space and now is the time for our members to band together to compete with payers in specialty pharmacy.

The Payer Team has done an excellent job enhancing awareness of our HTC network with payers. We have developed several key relationships with national brokers and consultants, mid-tier pharmacy benefit managers, third party administrators, large self-insured employers and stop loss/reinsurance carriers. By developing these payer relationships, we have been able to help bring back over 22,000,000 units of clotting factor to the HTCs pharmacy programs. As we have developed these payer relationships, there has been one common message from payers: they want a national HTC network as their solutions for managing bleeding disorders costs. This is an excellent opportunity to meet this payer need through our HANS PPO Agreement and bring more business to your pharmacy programs.

The Alliance Team began the rollout of HANS PPO Agreement to our Board Members in Spring 2019 and to all members this summer. To date, we have twenty-two (22) signed HANS PPO Agreements with members. While this is good start, we need significantly more members to sign the HANS Agreement to finalize the development of our national HTC network. Increasing the number of members that sign the HANS PPO Agreement during the first and second quarters of 2020 will be our number one priority.

We look forward to continuing our efforts and working with you to grow your pharmacy business in 2020.

Washington Update

By Johanna Gray and Ellen Riker

This has been another busy year in Washington! Here is a brief recap of what has been happening and how we have been working to advocate for HTCs and people with bleeding disorders:

Drug Pricing and Health Care Costs
Congress spent much of 2019 trying to reach consensus on how to address an issue that they all agree is a problem: high drug costs and high health care costs more generally. A number of competing legislative proposals were introduced during the year with the goal of addressing drug pricing, surprise billing (when a person gets a bill for an out-of-network provider at an in-network setting), and improving transparency to help lower patients’ out-of-pocket costs. While House and Senate Leaders and Committee Chairs and Ranking Members attempted to reach consensus on final bills that could be passed before the end of the year, they have not yet resolved their differences. Congress is expected to take up these issues again in the new year in hopes of passing something by May. President Trump also supports tackling these issues before the 2020 election. The Alliance had written letters to Congressional committees and met with staff to discuss how the policies under consideration could affect HTCs and their patients. We were concerned that these bills could be a vehicle for making changes to the 340B program, but they have not yet included anything significant related to 340B. We are continuing to monitor the situation and will continue to advocate on your behalf.

Hemophilia SNF Bill
We have been working to facilitate access to skilled nursing facilities (SNFs) for people with bleeding disorders on Medicare. The Alliance worked with NHF on a survey of HTCs social workers to garner more data on the issue. Representatives of NHF and the Alliance met with leaders of the Centers for Medicare and Medicaid Services (CMS) to discuss the issue and submitted a comment letter on the SNF regulation released in 2019. We ultimately learned (as we suspected) that legislation would be required to change the policy. We have been working for the last few months to identify champions in the House and Senate to introduce legislation to allow SNFs to bill separately for bleeding disorders treatments. We will have an update for the community very soon about introduction of the bill.

HTC Registration
The Alliance has been working with HRSA, OPA and the regional coordinators and directors to be able to give HTCs direction regarding when and how to register their outreach clinics and permanent clinical sites in the OPA database. We appreciate all of our colleagues who have been working with us to better define and resolve this issue. We hope to have an update for HTCs early in 2020.

Appropriations
As of this writing, Congress has finally reached agreement on final FY2020 funding bills. While Congress was unable to pass the twelve annual appropriations bills that fund the government before the start of the Federal fiscal year on October 1st, it did pass two short-term continuing resolutions (CR) to fund the government at current levels until December 20th to give them more time to consider year- long appropriations bills. The final Labor-HHS-Education spending bill includes level funding for the hemophilia programs and activities at CDC and HRSA and includes report language indicating Congressional support for activities at both agencies plus bleeding disorders-related research at NIH. Congress is expected to pass the appropriations bills, and the President is expected to sign it before funding expires at the end of the week.

Legal Update

Legal Team Update – NEW CONTACT INFORMATION

Starting January 1, 2020, Elizabeth ‘Issie’ Karan will embark on a new phase in her relationship with the Hemophilia Alliance and its member HTCs. Issie will continue to provide services to members but under her own newly formed law firm, the Karan Legal Group PLLC. Michael B. Glomb also will continue in his role but remain a partner at Feldesman Tucker Leifer Fidell LLP. Members can contact Issie at elizabeth@karanlegalgroup.com and Mike at mglomb@ftlf.com. The legal team looks forward to many productive conversations with members in 2020.

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Foundations for Grant Compliance: Rules Exist Even When Ignored
By Elizabeth “Issie” Karan

As 2019 draws to a close, rather than rehashing the myriad of grant-related questions that members asked the legal team, we would like to reiterate the primary sources for understanding appropriate expenditures in the Hemophilia Treatment Center (HTC) grant program. Often, the legal team utilizes these resources to answer grant-related inquires and interpret compliance concerns.

All grants begin with an authorizing statute. Section 501(a)(2) of the Social Security Act authorizes the HTC program as a special project of regional and national significance (SPRANS). The statute authorizes funding for:

“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 service.” (emphasis added)

The language of the statute is further interpreted by guidance from the Maternal and Child Health Bureau (MCHB), such as the Notice of Funding Opportunity (NOFO). Core Regional HTCs respond to the NOFO in order to receive grant funding. The NOFO provides insight into MCHB’s perspective on how HTCs should operate and the purposes of the program.

MCHB issues a Notice of Funding Award (NOFA) to each Core Regional HTC. The NOFA functions as the agreement between MCHB and the Core Regional HTC regarding the requirements for grant expenditures. Typically, the NOFA identifies conditions for expenditure of grant funds, time periods for expenditures, reporting obligations, and other requirements. Each Regional Core HTC’s application for funding also functions as part of their agreement with MCHB governing how funds will be expended.

Most HTCs participate in the program as subrecipients of grant funds under an agreement with their Regional Core HTC. These agreements are often referred to as “sub-awards” or “sub-recipient agreements.” HTCs must abide by the terms of their contract with the Regional Core HTCs. Often Regional Core HTCs incorporate their NOFA into this agreement.

All grants made by the Department of Health and Human Services are governed by the Uniform Grants Guidance at 45 CFR Part 75 (UGG). Importantly, the UGG includes the Cost Principles at Subpart E, which identify specific items of costs that may or may not be allowed under the rules. Additionally, the UGG defines program income, sets standards for procurement, and identifies restrictions on obtaining real property.

The Hemophilia Treatment Center Manual for 340B Participation (Manual), written by MCHB and available on the Hemophilia Alliance website, provides background information and practical advice on how HTCs can operate in compliance with 340B policy and related HTC program policy. Notably, the Manual contains information on program income, stating it must be used for “patient care and supportive services necessary to provide comprehensive care to patients.” The Manual also states that the grants awarding office may, on a case-by-case basis, allow a grantee to use the income for eligible costs that might not be expressly allowable costs under the terms and conditions of the award. Such cases require prior written approval from the grants awarding office. For HTCs, MCHB is the grants awarding office. Since most HTCs do not have a contract directly with MCHB, they must rely on their Core Regional HTC for prior written approval of expenditures. For example, the UGG’s Cost Principles do not allow the expenditure of grant funds for international travel. As such, prior to undertaking such an expense, HTCs must obtain prior written approval from their Core Regional Center, which likely will need to get approval from MCHB.

We recommend that HTCs keep these documents readily available and consult them as issues arise. As always, the legal team is available to help HTCs understand these resources and provide guidance.

Notes from the Community

Emergency Care for Patients with Hemophilia
Emergency Care for Patients with von Willebrand Disease

are now available online

These books have been updated in 2019 to include all products currently on the market and the latest recommendations. They are pdf documents, which you may download, add your HTC’s information, and print to give to patients, emergency rooms, and others who may find them beneficial. Go to http://www.greatplainsbcd.org/edu.htm to download them.

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2020 Thrombosis and Hemostasis Summit of North America (THSNA) Abstract Submission Open

Online abstract submission is now open for the 2020 Thrombosis & Hemostasis Summit of North America (THSNA). Abstract submissions will be considered for either a digital poster presentation and/or short oral presentation in each of the following program tracks: Thrombosis, Hemostasis, Laboratory, and Basic Science.

THSNA brings together the leading hemostasis and thrombosis organizations and experts to provide insight on improving patient care. This year's Summit will highlight basic science, clinical, and laboratory information that reflects the latest understanding of bleeding and clotting disorders.

The Summit will host over 1,500 healthcare professionals and coagulation scientists who are committed to the diagnosis, management and improved understanding of thrombotic and bleeding disorders.

For more information on abstract submission, please visit: https://www.thsna.org/2020/present-abstracts.php.

Alliance Update

2020 340B Program HRSA Grantee Recertification Period Begins in January

See below for a note from CDR Samuel N. Cardarella RN, BSN with details about the 2020 recertification process:

Dear 340B Stakeholders,

The 2020 340B Program HRSA Grantee Recertification period for Consolidated Health Centers, Federal Qualified Health Center Look-Alikes, Ryan White, Comprehensive Hemophilia Treatment Centers, Native Hawaiian, Black Lung Programs, Urban Indian, and Tribal Compact 638 will be January 27-February 24, 2020. There will be a recertification webinar held on January 22, 2020 from 1-2pm EST. A separate email will be sent out with all the information required to access the webinar.

Prior to being able to recertify, Authorizing Officials(AOs) and Primary Contacts(PCs) must set up a user account in the 340B Office of Pharmacy Affairs Information System (340B OPAIS). Failure to set up user accounts will result in not being able to view accounts or conduct recertification, thus removal from the 340B Program. AOs and PCs must create individual user accounts, they will not be able to share access. All active 340B ID’s associated with an AOs user account must be updated in order for recertification to be completed by the established deadline.

If any contact information has changed since last recertification or new ones need to be added, please send all information to Jvolpe@hrsa.gov prior to the start of recertification.

For assistance with the 340B OPAIS, I strongly encourage you and the covered entities to utilize the online help that is available for your convenience. HRSA also has information and tutorials available on our website at https://www.hrsa.gov/opa/340b-opais/index.html. For further assistance please contact the 340B call center operated by the 340B Prime Vendor Program at apexusanswers@340bpvp.com or 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. EST).

Regards,
CDR Samuel N. Cardarella RN, BSN
Program Management Officer
Operations Branch, Office of Pharmacy Affairs
Health Systems Bureau, Health Resources Services Administration
Office 301-945-0930
scardarella@hrsa.gov

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Operations and Marketing Update
By Sean Singh

Should old acquaintance be forgot, and never brought to mind?

As we ring in 2020, we don’t want you to forget about the things we did this year and what we continue to do to help you.

The Alliance team is excited to be able to help you start think and planning of the upcoming changes in our community. In 2019, Theresa Parker joined our team as the new Administrator for the organization. She has dedicated her time to learn about the community and our members. She is leading the rollout of the new Data Portal. The data portal is a repository of your purchase data that can be queried to look at trends about your HTC pharmacy. Theresa continues to look for ways to help us improve our service offerings, which include updates to our website, our library of presentations and legal documents.

We added Karen Bowe to our team as the Director of Community Relations. Karen brings over 30 years experience within the community including starting her career at the Hershey Medical Center HTC and then spending time with national specialty pharmacies and a manufacturer. She brings a great perspective and familiarity with hemophilia. She is very excited to be a part of the team and has jumped right wanting to be a big contributor to our team and assist our members.

We will continue to provide education opportunities for you through webinars and our in-person meetings. Getting to know your peers at other centers is vital, connecting you with a great resource to understand and work through similar issues. We are willing to facilitate education efforts that you need or want and always welcome feedback about topics you would like to hear about. In addition to our Spring Members meeting with Hill day visits and fall members meeting, we will be adding a third meeting in 2020. The meeting will be held May 6th to 8th in Minneapolis. This meeting will be for new HTC team members and team members who have not been to an Alliance meeting. The Alliance will pick up the costs for the HTC staff member to attend the meeting. The meeting will be supported by our manufacturing partners.

In the upcoming year, we will be sending out a survey to better understand your needs in the areas where we offer support. This survey will be sent to one individual at each center and we do hope you spend the time to complete it. The survey will go out in the first quarter of 2020.

We see opportunities and challenges for the upcoming years. We want to remind you that the operations team and entire Hemophilia Alliance team are here to help you prepare for the changes and help you come up with a plan to be sustainable and continue to support your patients. Whether it be an audit or helping with proformas to help you navigate financial changes or to help orient new staff, WE ARE HERE FOR YOU. In addition to your primary contact, you can always reach out to any member of the Alliance team.

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2020 Meeting Schedule

  • Board Retreat: January 12th to 14th
  • Social Worker Conference: February 26th to 28th
  • Spring Members Meeting: March 29th and 30th
  • Hill Day visits: March 31st
  • Meeting for New HTC Members: May 6th to 8th
  • Fall Members Meeting: To be announced


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