May 2019 Newsletter

In this Issue…

Notes from Joe
· Hill Day Recap

Legal Update
· External, Independent Audits of 340B Contract Pharmacies: Where do they come from? What are they? Where are they going?***

Washington Update
· CMS Releases New Policy to Limit Co-pay Accumulator Programs

Payer Update

Alliance Update
· Alliance Seeking Director of Community Relations

Notes from the Community
· CDC Division of Blood Disorders Announces Next Public Health Webinar Series on Blood Disorders

Team Alliance Contact Information

Notes from Joe

Hill Day Recap
By Joe Pugliese

Our 7th annual Hill day was on April 30th. We had a good turnout from our members and were pleased again to have representatives from the National Hemophilia Foundation and Hemophilia Federation of America, as well as some of our industry partners, CSL Behring, Octapharma and Sanofi Genzyme. The real stars of course were the patients who joined us on the visits to Congressional offices: 20 patients and family members went with their hemophilia treatment center staff to drive home how critical their center of excellence is to their well-being. You can see photos from our Hill Day throughout my article and there is a link to even more images below.

As discussed last month, the recent article, “Population‐based surveillance of haemophilia and patient outcomes in Indiana using multiple data sources,” reaffirmed what the community has long known: the HTC comprehensive care model delivers the best clinical care and superior clinical care delivers better outcomes and lower costs. While the HTC story is a great on, it is up to us to continually educate others about the tremendous value that HTCs offer.


Participants in our Hill Day were enthusiastic and their messaging was excellent, but I have to admit that I was personally disappointed that we did not have twice as many HTCs and twice as many patients. There are many good reasons for people not attending. Our Hill day conflicted with two regional meetings and it has been a remarkably busy spring for meetings. Other people worry about getting permission from their institutions, but please know that we can address those concerns well ahead of the meeting. Some feel like their voices won’t be heard or want to limit their advocacy to the state level. But, upwards to 70% of Medicaid funding comes from the federal government and many Medicaid changes require approval from Washington. With all of the challenges facing HTCs, it certainly cannot hurt to have your Senators and Representatives supportive of your centers and even weighing in on your behalf.

There is one good reason to make the trip: you are uniquely qualified to tell your story. Please mark your calendars for our 2020 Spring Meeting and Hill Day, which will be held March 29-March 31, 2020. We’ll start with a networking reception on the evening of March 29th, have the member meeting on March 30th and will head to the Hill on the 31st. I look forward to seeing you there.

Click here to view more images taken on Hill Day.

Legal Update

External, Independent Audits of 340B Contract Pharmacies: Where do they come from? What are they? Where are they going?***
By Elizabeth “Issie” Karan

Hemophilia Treatment Centers (HTCs) often ask whether they need to get an external, independent audit of their 340B program contract pharmacies. The short answer is that the Office of Pharmacy Affairs (OPA) expects covered entities to have contract pharmacies audited by an external, independent auditor annually. However, in the 2010 contract pharmacy guidelines, OPA stated that “[t]he precise methodology utilized to ensure compliance and obtain the necessary information is up to the covered entity given its particular circumstances.” Given this flexibility and the expense associated with independent auditors, often HTCs wonder how to practically meet this expectation without breaking the bank every year.

Although OPA wants covered entities “to conduct annual audits of contract pharmacies that are performed by an independent auditor”, more details on the expectation are limited. FAQ 1422 on the Apexus website states that “HRSA expects that covered entities will utilize independent audits as part of fulfilling their ongoing obligation of ensuring 340B Program compliance. 340B Program violations found during internal or independent audits must be disclosed to HRSA along with the covered entity’s plan to address the violation.” (Please note OPA only requires disclosure of material breaches of compliance.) In a memorandum to the then Administrator of the Health Resources and Services Administration (HRSA), the Office of the Inspector General (OIG) at the Department of Health and Human Services emphasized the “expectation” that covered entities will have annual, external independent audits.

Now, during its audit of a 340B program, OPA asks for documentation that the covered entity conducted an external, independent audit of its contract pharmacies that year. (Please note that we recommend obtaining a letter from auditors, stating when the audit was complete, rather than providing OPA with your actual audit report.) If covered entities cannot produce such documentation, it’s a problem. OPA may view the lack of an audit as contributing to inadequate oversight of contract pharmacies by the covered entity. Such evidence can lead to a finding which may result in termination of a contract pharmacy from a covered entity’s 340B program.

HTCs have options when conducting an annual, external, independent audit of its contract pharmacies. We suggest that HTCs seek out auditors who understand their operations or at least have experience with specialty pharmacy operations. Additionally, HTCs could consider less traditional methods for meeting this obligation, such as partnering with a peer HTC to audit each other’s programs. We believe rotating between peer audits and expert audits ensures compliance while saving money.

HTCs also must consider other methods to oversee contract pharmacy arrangements as annual, external audits, in and of themselves, are insufficient to meet compliance obligations. Most commonly, covered entities compare documentation from contract pharmacies with internal records to ensure compliance with prohibitions against duplicate discounts and diversion.

If you have additional questions, please contact Elizabeth (Issie) Karan at ekaran@ftlf.com.

***extra credit to anyone who gets the Gauguin reference!

Washington Update

CMS Releases New Policy to Limit Co-pay Accumulator Programs
By Johanna Gray

On April 18, 2019, the Centers for Medicare and Medicaid Services (CMS) released the final Notice of Benefit and Payment Parameters Rule for 2020. This is an annual rule that sets policies for private insurance plans. In the 2020 Final NBPP Rule, CMS finalized a policy that only allows plans to implement co-pay accumulator programs in limited scenarios – only for brand name drugs when there is a generic alternative, and only when an appeals or exceptions process has found that the brand name drug is not medically necessary. Co-pay accumulator programs essentially disallow co-pay assistance from counting towards a person’s out-of-pocket (OOP) maximum. CMS has specifically said that in cases where there is no generic alternative, co-pay assistance should accrue to a person’s OOP max. Since our treatments do not have generic alternatives, this rule should significantly reduce the effects of co-pay accumulator programs for the bleeding disorders community starting in 2020.

We are very pleased that CMS has indicated that accumulator programs should not apply to our patients and products. Accumulator programs have been a growing concern for our patient community and many organizations including the Alliance have been involved in advocacy on a number of levels (federal, state, directly with payers). We have to acknowledge the leadership role that NHF played on the national level with the All Copays Count Coalition in seeking this change from CMS. We have sought more information from the Agency and from payers about how this new policy will be implemented. We will update the community as the situation is clarified.

Payer Update

By Jeff Blake

At our Spring Member Meeting, we announced we will be rolling out our Hemophilia Alliance Network Services (HANS) National HTC PPO Network. We are excited about the creation of this formal HTC PPO Network. This new network agreement will include:

  • Formal PPO agreement between HANS and Member HTC
  • Key terms and obligations/requirements for HANS and the HTC
  • Bleeding disorder products coverage issues or limitations
  • Reporting requirements

Soon, you will each hear individually from a payer team representative about the specific terms applicable to PPO participation.

The goals of the PPO Network are to contract with regional and national payers with whom HTCs do not have contracts. These new contracts will provide HTCs the opportunity to increase the number of patients that utilize your pharmacy programs. We will be marketing the HANS HTC PPO Network to payers including:

Insurance Companies Pharmacy Benefit Managers (PBMs)
Third Party Claims Administrators (TPAs) Insurance Brokers/Consultants
Self-Insured Employers Employer Health Care Coalitions
Reinsurance/Stop Loss Carriers Pharmacy Benefit Managers (PBMs)

We also provided an update on The Alliance Pharmacy (TAP) and how members can work with TAP as a backstop for your pharmacy. TAP is a licensed pharmacy in all 50 states. Below are several ways TAP can serve as a contract pharmacy to support your pharmacy program:

  • For HTCs that are starting a pharmacy program
  • When HTCs can’t dispense (licensing issue, payer issue)
  • When HTCs operate as a physician dispense model and cannot bill electronic pharmacy claims
  • For disaster recovery

If you have any questions, please contact a member of the Hemophilia Alliance Team.

Alliance Update

Alliance Seeking a Director of Community Relations

We want you to be a member of the Hemophilia Alliance Team!

We are looking for a Director of Community Relations. Here is the job description. Interested candidates please send a CV and letter of interest to Sean Singh at sean@hemoalliance.org.

Director Community Relations

Summary: The Director of Community Relations reports to the Senior Vice President, Marketing and Operations of the Hemophilia Alliance. The position is responsible for the daily operations and interactions with member centers and external partners.

Key Functions:

  1. Supports the mission of the Hemophilia Alliance “The Hemophilia Alliance works to ensure member Hemophilia Treatment Centers (HTC) have the expertise, resources and public support to sustain their integrated clinical and pharmacy services for individuals with bleeding and clotting disorders.”
  2. Meets with HTCs and institution personnel with a commitment to improve, educate and support the center’s efforts to take care of their patient and sustain their HTC.
  3. Have an understanding and remain current with the 340B Program rules, regulations and potential changes that may impact members.
  4. Work with confidential information and uses discretion when interacting with members, partners, manufacturers and the public.
  5. Public speaking at meetings, conferences, patient events as directed.
  6. Conducts video and phone conferences effectively and efficiently while using current technology in a variety of platforms.
  7. Committed to learning and educating how the Hemophilia Alliance supports the bleeding disorders community.
  8. Have an understanding on working on websites and technology skills. Proficient in Microsoft Office.
  9. Participates in the development and implementation of the approved communications strategic plan.
  10. Participates in Federal and State initiatives that affect the 340B program.
  11. Provides operational training, technical and regulatory guidance and assistance so HTCs can effectively manage and operate their pharmacy programs.
  12. Collaborate with national, state and local patient advocacy organizations.
  13. Attends conferences and trade organization meetings as requested to stay current with market trends and promote member HTCs as Centers of Excellence.
  14. Work with the Hemophilia Alliance GPO, Advocacy, Payer Relations, Membership, and Communication teams/consultants to provide operational support and assistance as necessary.
  15. Assist the Payer Relations Team with their ongoing efforts with insurance payers and member HTCs.
  16. Highly motivated to take on other duties that arise as a result of changes in the bleeding disorders community and the healthcare arena.

Travel: Approximately 40% of time traveling to HTCs, conferences, member HTCs and advocacy events is expected. Must possess a valid driver’s license and be able to travel.

Location:
This position will be based on the East Coast of the US. The position will cover member centers in the North East.

Qualifications/Experience:

  • Knowledge of hemophilia and bleeding disorders that has been gained by working in and or by being a member of bleeding disorders community.
  • Understanding the business of the healthcare market.
  • Ability to work independently and on a virtual team.
  • While working with a team, must be able to set and organize priorities and adapt to frequent change.
  • Excellent verbal, written and interpersonal communication skills.
  • Strong analytical, financial and organizational skills.
  • Highly motivated to use, interact and develop technology.
  • Willingness to learn and gain knowledge.
  • Must possess a personal presence that is characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, vision, mission, goals, and values of the Hemophilia Alliance.

Preferred Qualifications:

  • Bachelor’s Degree.
  • Five or more years professional experience in the bleeding disorders community.

Notes from the Community

CDC Division of Blood Disorders Announces Next Public Health Webinar Series on Blood Disorders

Public Health Webinar Series on Blood Disorders: Bringing Science into Practice

The CDC Division of Blood Disorders is proud to offer this webinar series, providing evidence-based information on new research, emerging issues of interest in blood disorders, as well as innovative approaches to collaboration.

New Opportunities and Challenges in Hemophilia Care: 2019 Update

June 6, 2019 • 2:00–3:00 pm ET

Guy Young, MD
Director, Hemostasis and Thrombosis Center at Children’s Hospital Los Angeles
Associate Professor of Pediatrics at the University of Southern California Keck School of Medicine

More information may be found in this flyer. Please preregister here: http://www.hemophiliafed.org/CDCwebinar.


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
Audra Ames audra@hemoalliance.org 727-415-6397
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
Joel Bellucci webmaster@hemoalliance.org 727-504-0491