July 2019 Newsletter

In this Issue…

Notes from Joe
· A Penny for your Thoughts

Alliance Update
· Meet our New Board Members: Laurie Reger and Chris Guelcher

Legal Update
· Recordkeeping and Retention: If You Can’t Prove It; It Didn’t Happen

Payer Update
· TAP, TAP, TAP: How Healthy is your Contract Pharmacy Portfolio?

Notes from the Community
· VWD Connect Foundation Annual Conference Recap

Team Alliance Contact Information

Notes from Joe

A Penny For Your Thoughts
By Joe Pugliese

Last month, I did a quick review of our performance year to date versus our strategic goals. At the same time we sent out two new survey requests and we know you feel surveyed to death. As a reminder, we provide a substantial grant to ATHN every year to fund data managers to assist HTCs across the country in collecting data. The Hemophilia Alliance has a firm policy of not participating in blinded market research. We adopted this policy years ago because of concerns about who would get the information and how it would be used. We continue to recommend to our members to decline to participate for the same reason, in addition to the time involved. The two surveys we sent out were generated through a combined effort of the Hemophilia Alliance and the National Hemophilia Foundation and we feel strongly that they will provide important information to support HTCs operational and clinical services.

The first was a survey trying to quantify the negative impact of the lack of reimbursement for clotting factor for patients needing skilled nursing facility (SNF) services. We are delighted that we received 44 responses. We’re currently working to analyze the data, which we will use in our legislative advocacy to address this problem in Washington. If you haven’t completed the survey and want to share your center’s experience with SNF services, please contact Johanna Gray. While a relatively small percentage of the bleeding disorders population is covered by Medicare, it is a big problem for those impacted. This issue will grow as the hemophilia population continues to grow older thanks to the current and evolving clinical care model and the current and pending new therapies.

The second survey came out of the work being done by the Comprehensive Care Sustainability Collaborative (CCSC). The CCSC, as the name states, is a program started by NHF to help sustain the comprehensive care model and enhance relationships with payers. It brings together treatment center staff, NHF staff and payers to create opportunities for HTCs to stay or get into network. We have received 46 responses to date. If you have not responded yet you can access the survey here. The collaboration with NHF through CCSC and the continued joint efforts of our payer team and the Advocacy team at NHF has resulted in very tangible benefits for members across the country. We have captured a significant number of clotting factor units for HTC member pharmacies across the country and have in excess of 50 current opportunities to double that number in the near term. I think we are going to build on that success.

The two surveys mentioned above and the HTC Insurance Questionnaire/Payer Survey we have been using for the last 2 years seek to support and advance the cause of HTCs that provide optimal care to patients with bleeding disorders.

As you have heard from us consistently over time our goal is to find ways to collaborate with all stakeholders in the community. As a community we do not lack for opinions on the best way forward. I stated last month we always encourage feedback which helps us move forward. We are most likely to succeed in our vision if we constantly look for ways to work together.

Alliance Update

Meet Our New Board Member – Laurie Reger, Executive Director, Western New York BloodCare HTC

I entered the work of Hemophilia and other bleeding and clotting disorders in January of 2012. I accepted the position of Executive Director of the Western New York HTC following the retirement of my predecessor, the late Rosemary “Penny” Holmberg. Our HTC was founded in 1969 and mirrored the Mary Gooley Center in Rochester, NY. The organizational design of our HTC is a dual Chapter of the NHF as well as a Diagnostic and Treatment Center. As we stand today, our Independent life span HTC has a dual title of HTC and Chapter Organization.

Our HTC clinics originated in the Erie County Medical Center for our adults and Children’s Hospital of Buffalo for our pediatrics. Our staff consisted of an MD and RN. In 2009, using our 340B funds, we relocated both of these clinics into one, stand-alone building and added staff to accommodate the growing needs of our patient population. In 2011, we opened a Special Coagulation Laboratory to service our patients and expanded our services to include more thrombosis. In 2017, we established a clinic for girls and women with heavy menstrual bleeding and called it the S.H.E. clinic (Specialized Hematology Experts) under the direction of our Hematologist and a partnering OBGYN. In 2018, our Board of Directors voted to rebrand our Center under a new name to better reflect the variety of patients we are now serving. We are now known as Western New York BloodCare. In June of this year, we will be moving our HTC into a 10,000 square foot single floor plan located within the Niagara Medical Corridor. This relocation aligns us in close proximity to the new John O’Shei Children’s Hospital, The Gates Vascular Institute, The Buffalo General Hospital, Roswell Park Cancer Institute and the University of Buffalo Medical School. We have also partnered with the University to fund a five year Career Development Award in Hemostasis and Thrombosis to assist in the education and research of nonmalignant Hematology as well as a fourth year Clinical Fellowship in Hemostasis and Thrombosis.

There are many exciting changes in our community and our HTC continues to explore opportunities to advocate for patient access to new therapies and advances in care. We are considering the introduction of telemedicine services to our patient base to help bring our expertise to the outreaches of our catchment area.

I am very excited to become part of the Hemophilia Alliance Board and to network with the top experts in the area of business and medicine to further support our patient community and improve their health outcomes.

Laurie holds a Master’s Degree in HealthCare Administration from D’Youville College and a BS in Physical Therapy where she practiced clinically for twenty five years. Her previous experience in HealthCare Administration includes managing Outpatient Clinics in Maternity and Women’s Health, Pediatrics, Rehabilitation as well as Physician Recruitment and Retention in Wyoming County NY.

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Meet Our New Board Member – Chris Guelcher, Hemophilia Nurse Coordinator, Hemostasis and Thrombosis Treatment Center at Children’s National Health System

Chris Guelcher has been a hematology/oncology clinic nurse for 30 years. After graduating from Georgetown University with a Bachelors of Science in Nursing she worked on an inpatient Hematology/Oncology unit at Children’s Memorial Hospital in Chicago, Illinois and later at Mott Children’s Hospital in Ann Arbor, Michigan. Since coming to Children’s National Health System (CNHS) in 1992, she has worked on the inpatient unit and in the outpatient clinic as a Hematology/Oncology nurse. After completing her Masters in Science at the University of Maryland and becoming certified as a Pediatric Nurse Practitioner, she has been the Hemophilia Nurse Coordinator at CNHS since 1997. Chris is also an ANCC Board Certified Hemostasis Nurse.

Chris has been involved in the hemophilia community in a number of ways over the years; as member of the NHF Nursing Working Group, the Women with Bleeding Disorders Working Group, the Region III Regional Executive Committee (REC). She is now the US representative to the World Hemophilia Federation (WFH) Nursing Work Group.

Chris has been an active member of a number of professional organizations as well. Chris was a member of the American Thrombosis and Hemostasis Network (ATHN) Board of Directors for 10 years, serving as the Secretary for two years. She served on the Education Subcommittee for the American Society of Pediatric Hematology and Oncology (ASPHO) and moderated three webinars. Chris was part of the Hemophilia and Thrombosis Research Society annual planning committee for the 2009 and 2010 meetings. In 2011 she helped plan and presented at the first Thrombosis and Hemostasis Summit of North America (THSNA). Chris continues to serve as a liaison to the THSNA Board of Directors and she was on the planning committee for the 2016, 2018 and the upcoming 2020 THSNA meetings. In 2019, Chris was selected to join the Hemophilia Alliance Board of Directors.

Chris was part of the faculty that worked with the Centers for Disease Control to develop the curriculum for the “Advanced Partners Program”. She continues to work with the faculty members to keep the curriculum current and present as part of the faculty twice a year. Chris has published manuscripts and chapters and presented at numerous professional and consumer meetings. Chris was the recipient of the Trish Dominic Award in 2018 for her dedication and service to the ATHN Board and the bleeding disorder community.

The Hemostasis and Thrombosis Treatment Center at Children’s National Health System serves well over 500 patients with bleeding disorders and thrombosis/thrombophilia. Our multi-disciplinary team provides comprehensive care with clinics weekly for patients with bleeding disorders and thrombosis. We also have two outreach clinics monthly, one in Northern Virginia and another in Suburban Maryland. Our physical therapist can provide clinical joint/muscle assessments with point of care ultrasound as well as measure for gradient compression garments. We have a formal transition policy with annual assessments to identify gaps and prepare for each transition along the way.

In addition to our comprehensive clinics, we have a menorrhagia clinic twice monthly which is staffed by a Hematologist and Gynecologist.

We participate in a number of research initiatives, including industry-sponsored, federally funded and investigator-initiated projects. We coordinate with our local chapter to plan programing for patients and families. In 2019, we worked with the other federally funded HTCs in DC, MD and VA to plan and present our annual Region III Mid-Atlantic HTC conference.

Legal Update

Recordkeeping and Retention: If You Can’t Prove It; It Didn’t Happen
By Elizabeth "Issie" Karan

Hemophilia Treatment Centers (HTCs) must comply with numerous recordkeeping standards, and we regularly get questions regarding how long to maintain records. Importantly, if something is not recorded, it doesn’t exist. This includes policies and procedures, audits, meetings, and anything else an HTC wants to document occurred for compliance reasons. Do not let perfection be the enemy of the good when it comes to recordkeeping. If a call or meeting occurs for which an HTC wants a record, take notes, record the date, and include who participated. If an incident occurs that an HTC investigates, create a memorandum to file documenting these efforts. If an auditor comes to your HTC, they cannot take your word that something happened. They will expect documentation.

The Office of Pharmacy Affairs (OPA) puts a premium on maintenance of auditable records by Covered Entities (CEs) participating in the 340B discount drug program (340B Program). In guidance from May 1994, OPA required CEs to keep purchasing records for all drugs acquired in the 340B Program. Additionally, the 340B statute requires CEs to have records for audit purposes. Specifically, the 340B statute reads:

340B(a)(5)(C) AUDITING.—A covered entity shall permit the Secretary and the manufacturer of a covered outpatient drug that is subject to an agreement under this subsection with the entity (acting in accordance with procedures established by the Secretary relating to the number, duration, and scope of audits) to audit at the Secretary’s or the manufacturer’s expense the records of the entity that directly pertain to the entity’s compliance with the requirements described in subparagraphs (A) or (B) with respect to drugs of the manufacturer.

The references to subparagraphs (A) and (B) in the above text relate to the prohibition on duplicate discounts and diversion. Therefore, in addition to maintaining purchasing records, CEs must be able to show, during an audit, that they have not diverted 340B purchased drugs or provided them to Medicaid fee-for service patients (unless the CE has an agreement in place with the state to do so and has notified HRSA of such an arrangement). In guidelines related to manufacturer audits, HRSA indicated that CEs should maintain records to demonstrate the distribution and use of covered drugs for a period of not less than 3 years. This may sound simple in theory but can be complex in practice.

The Health Resources and Services Administration (HRSA) created a peer-to-peer program and documented best practices from the field in its 340B Compliance Improvement Guide. This guide covers many aspects of 340B Program compliance, including recommendations for recordkeeping. Please note that these best practices are not necessarily required but may assist in practically approaching recordkeeping in the 340B Program. In addition, we recommend keeping documentation of any communications with the government and Apexus and taking screenshots of important registration pages and windows. Just because something exists online now, does not mean it will in the future.

HTCs must comply with other record retention standards, including for HIPAA, federal grants compliance, and other areas of relevant law. The following chart summarizes some of these standards. We encourage HTCs to review these standards, keeping in mind the operational and other unique characteristics of your organization. As always, please contact us with questions or concerns.

Payer Update

TAP, TAP, TAP: How Healthy is your Contract Pharmacy Portfolio?
By Mark Plencner

What can you do to improve your opportunities to serve more of your patients? Everyone understands healthcare is in a season of change. “Disruptive Medicine” seems to be the new buzz phrase, having seemingly overtaken the older and often overused “Paradigm Shift.”

Hemophilia patients and HTCs are experiencing disruptive medicine as never before. Medication breakthroughs such as extended half-life clotting factors (EHLs), bi-specific monoclonal antibodies, and Gene Therapy, once seen as a distant light, are becoming integral parts of hemophilia care or may soon do so. Third party payer and prescription benefit manager business initiatives such as vertical integration, exclusive specialty drug carve-outs, and specialty pharmacy proliferation continue to challenge HTC’s efforts to stay in network, maintain their revenue source and continue to practice integrated care that greatly benefits the hemophilia community.

The Hemophilia Alliance now in its 20th year, has worked thoughtfully and diligently to develop programs and services to help keep your program financially healthy. One important offering has been our association with The Alliance Pharmacy (TAP) as a contract pharmacy option.

We know our member HTCs have an array of pharmacy relationships:

  • HTCs that work exclusively through their in-house pharmacy (which may or may not be registered as a contract pharmacy for the HTC).
  • HTCs that have no in-house pharmacy and work exclusively with one contract pharmacy.
  • HTCs that have several contract pharmacies registered to maximize access to Payer contracts.
  • Some combination of the above.

The Hemophilia Alliance has a strong relationship with TAP. Licensed in 50 states, TAP has wholesale distribution and pharmacy capabilities which can assist your HTC in several ways:

  • Serve as a backup contract pharmacy to support disaster recovery efforts.
  • Provide a source of revenue to start-up programs who are waiting for HTC or pharmacy registration through OPA.
  • Provide a pharmacy option for HTCs that use a Physician Dispense Model and can’t submit a “pharmacy” claim.
  • Dispense clotting factor out of state to patients who are vacationing or away to college in states where your primary contract pharmacy is not licensed.

There is no downside to registering TAP as a contract pharmacy. It costs nothing and will only provide products to patients when asked to do so by the provider, the patient, or both.

If you would like more information about TAP or to discuss contracting with TAP, please contact one of our Hemophilia Alliance Team Members. TAP has developed a generic contract pharmacy template with flexible language that does not commit your HTC to any action but allows for a backup pharmacy option on a moment’s notice. Now is an excellent opportunity to consider TAP as a contract pharmacy.

Notes from the Community

VWD Connect Foundation Annual Conference Recap
By Jeannette Cesta, VCF Executive Director

VWD Connect Foundation (VCF) held the 3rd Annual National Type 3/Severe Von Willebrand Disease Conference in Palm Beach Gardens, Florida on June 28-July 1, 2019. The conference provided a four-day patient education conference for Type 3 and severe VWD patients, along with a companion. Over 60 Type 3/severe VWD patients attended this year’s conference.

VCF is a non-profit organization established to serve the bleeding disorder community, focusing on severe Von Willebrand Disease. They provide education and connection for patients and families, and support research which will benefit the Von Willebrand Disease community.

The 2019 conference’s faculty provided educational sessions and small discussion groups. Faculty members included Christopher Walsh, MD, Mt. Sinai Hospital, New York, NY, Tung Wynn, MD, UF Health Shands Children’s Hospital HTC, Gainesville, FL; Robert Montgomery, MD, Blood Research Institute and Medical College of Wisconsin, Milwaukee, WI, Robert Sidonio, MD Aflac Cancer and Blood Disorders Center, Atlanta, GA and Beverly Schaefer, MD, WNY BloodCare Oishei Children’s Hospital, Buffalo, NY. The faculty also included experienced medical providers and health educators from a diverse group of disciplines such as physical therapy, OB/Gyn, genetic counseling, dental, HTC social workers and nurses.

Medical session topics included diagnosis, symptoms, treatments, prophylaxis, genetics, infusion techniques, nosebleeds and joint challenges. Psychosocial sessions addressed the issues of pain, depression, anxiety, disclosure, parenting, aging, transitioning and insurance. A breakfast symposium was held during the conference focusing exclusively on period management.

During the conference, an anonymous Audience Response System (ARS) was used to provide immediate feedback for attendees and faculty to make the content most relevant to the attendees’ needs and to collect patient self-reported experiences. Participating in the ARS provided a wonderful opportunity for patients to have their voices heard concerning challenges, needs and experiences in living with Type 3/Severe VWD.

For more information about VWD Connect Foundation, the conference or other Foundation activities, please contact Jeanette Cesta, Executive Director, at JCesta@VWDConnect.org or 561-373-3889.


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