In this Issue…
Advocacy and Legal Update
· OPA Releases Much Anticipated Alternative Dispute Resolution Rule for the 340B Program
· New Leadership at the Office of Pharmacy Affairs
· Matsui Introduces Legislation to Codify the Use of Contract Pharmacies in the 340B Program
Washington Update
· Hemophilia Alliance Hill Day Focuses on 340B and Alternative Funding Programs
Member and Community Relations Update
· Linda Gammage Social Work Conference Great Success
Marketing and Operations Team Update
· Post-New HTC Staff Orientation Update
· Upcoming Meeting Schedules
Notes from the Community
· 4th National HTC Patient Satisfaction Survey Underway
by Elizabeth ‘Issie’ Karan, Legal Counsel
- OPA Releases Much Anticipated Alternative Dispute Resolution Rule for the 340B Program
-
- Establishes a less trial-like process in order to make ADR more accessible to smaller covered entities with fewer resources;
- Revises the structure of the 340B ADR panel so that it is comprised of 340B program subject-matter experts—only from the Office of Pharmacy Affairs, rather than also including representatives from other offices, like the Centers for Medicare & Medicaid Services and the Office of the HHS Secretary;
- Includes additional screening for ADR panel members;
- Requires the establishment of deadlines and procedures that ensure that claims are resolved fairly, efficiently, and expeditiously;
- Requires the parties to have worked in good faith before proceeding through the ADR process;
- Aligns the ADR process more closely with the provisions of the 340B statute on diversion, duplicate discounts, and overcharges; and
- Creates a reconsideration process for parties dissatisfied with the ADR panel’s decision.
- New Leadership at the Office of Pharmacy Affairs
- Matsui Introduces Legislation to Codify the Use of Contract Pharmacies in the 340B Program
On April 18, 2024, the Health Resources and Services Administration (HRSA) and the Department of Health and Human Services (HHS) released a final rule on the Alternative Dispute Resolution (ADR) process in 340B. This version of the rule makes significant changes to the process first established in the last days of the Trump administration. More specifically, the final rule:
The final rule includes Medicaid managed care claims in the ADR process which covered entities had advocated for being excluded. It also indicates that the government will release only limited, very brief summaries of ADR case results, which is similar to how HRSA posts audits of covered entities and manufacturers. As such, covered entities face uncertainty on the standards being used for Medicaid managed care claims by the ADR Panel and insight into how the ADR process truly works.
In the rule, HHS commits to publishing policies and procedures for screening panel members on a HRSA public-facing website within 120 calendar days of the publication of the final rule. The rule will go into effect 60 days after it is published in the print version of the Federal Register. The Hemophilia Alliance will continue to analyze the final rule and provide updates to HTCs as needed.
Earlier this month, the Health Resources and Services Administration (HRSA) announced Chantelle Britton as its next Office of Pharmacy Affairs (OPA) director. Britton has been serving as acting director since the departure of U.S. Public Health Service Lt. Cmdr. Emeka Egwim in December.
According to HRSA officials, Britton previously served as senior advisor in the Office of the Director of OPA for eight years, under Rear Adm. Krista Pedley, who now heads HRSA’s Office of Special Health Initiatives (OSHI) which oversees OPA and a number of other offices within HRSA. Britton joined HHS in 2006 and has held positions at the Centers for Medicare & Medicaid Services, HRSA’s Office of Legislation and the White House Office of National AIDS Policy/Domestic Policy Council. She received her bachelor’s degree in political science and political communications in 2004 from James Madison University and has two master’s degrees: one from Howard University and one from Maryland University of Integrative Health. The Hemophilia Alliance looks forward to working with Director Britton in her new role.
On March 12, 2024, Representative Doris Matsui (D-CA) introduced the 340B PATIENTS Act (HR 7635), legislation that would protect and strengthen the 340B program by codifying 340B providers’ ability to use contract pharmacies to dispense 340B discounted drugs. More specifically, the legislation requires manufacturers to offer 340B discount prices to covered entities regardless of the manner or location in which a drug is dispensed, including if a covered entity uses a contract pharmacy to dispense 340B drugs to the entity’s patients. IT also prohibits manufacturers from placing conditions on a covered entity’s purchase and use of 340B drugs, including through contract pharmacies. To enforce these requirements, the legislation imposes civil monetary penalties on manufacturers that violate the bill’s statutory requirements and prohibitions.
The press release of the legislation includes endorsements from 340B Health, the American Hospital Association, and the American Society of Health-System Pharmacists. News outlets indicate additional support from the covered entity community in the AIDS Healthcare Foundation and the Advocates for Community Health (which represents FQHCs). By contrast, ASAP 340B, the nonprofit group that was formed by PhRMA and the National Association of Community Health Centers said broader legislation is needed.
HTCs largely remain unimpacted by contract pharmacy restrictions from manufacturers. However, the Hemophilia Alliance will evaluate this legislation and keep the community apprised of any developments.
Hemophilia Alliance Hill Day Focuses on 340B and Alternative Funding Programs
by Ellen Riker and Johanna Gray, Artemis Policy Group
With the goal of educating Members of Congress on the importance of the 340B Drug Discount Program to Hemophilia Treatment Centers (HTCs) and the bleeding disorders community, 120 advocates headed to Capitol Hill representing various members of the multi-disciplinary HTC team and their patients on April 18, 2024. In addition, we shared issues related to Alternative Funding Programs, being faced by some patients that are insured by large, self-insured employers. The participants in Hill Day found staff and Members visited to be very interested in what we had to say and willing to be supportive.
In visits advocates made the point that we needed Congress to support maintaining HTCs’ ability to participate in the 340B Program, so that centers can continue to serve patients, who benefit from access to lower-cost drugs and the medical, dental, physical therapy, and social services-based support and education that HTCs provide. We also shared our concerns regarding the spread of alternative funding programs (AFPs) that harm patients, payers, and taxpayers. Specifically, we sought support measures to ensure that insurance plans cannot exclude coverage for high-cost medications for the sole purpose of redirecting validly insured patients to manufacturer patient assistance funds. Insurers must also be required to consider medical necessity appeals for drugs not covered.
We want to share with all members of the Hemophilia Alliance the Fact Sheets and Talking Points that were used for Hill Day. Since all Representatives and over a third of the Senate are up for reelection this November, HTCs should consider meeting with Members of Congress and staff over the summer when they will be spending more time at home. Requesting a meeting in the district office is not difficult and even talking to someone on the phone is an opportunity to tell our unique story. The Fact Sheets are handouts for these visits and the talking points can be used as a script for your meetings.
Please contact Johanna Gray (jgray@artemispolicygroup.com) or Ellen Riker (eriker@artemispolicygroup.com) if you need assistance in contacting the legislators that serve your district and state.
Linda Gammage Social Work Conference Great Success
by Member and Community Relations Team
Forty-five social workers from around the country convened in New Orleans, Louisiana for the 26th annual Linda Gammage Social Work Conference. The conference this year was a rewarding and inspiring experience for all.
The education provided was focused specifically on diversity, equity, and inclusion (DEI). Sonjhia Lowery, CEO and founder of Just SCORE Inc. led the group through a journey towards culturally proficient advocacy and inclusive patient care by focusing on systemic issues in our health care system, challenging our own beliefs/values, and providing concrete skills for addressing microaggressions and racism within the systems in which we live and work. The speaker was dynamic and knowledgeable; all the attendees were left with a deeper understanding of diverse communities and an improved ability to provide culturally sensitive support and equitable care, and to foster justice and inclusivity in health care. The group expressed a commitment to applying the principles learned in their treatment center and within their lives with a planned 3-month check-in.
The following day, the group took a tour of Historic New Orleans by bus. The tour focused on New Orleans as a center for activism during the civil rights movement, and attendees experienced a comprehensive and immersive experience of culture and history. It was a concrete way to bring home the DEI concepts learned from Sonjhia Lowery.
The Linda Gammage Social Work Planning Committee and the social work attendees would like to extend a special thank you to CSL Behring for the support of this conference since its inception in 1997. This conference has always been meaningful and impactful on psychosocial practice and care.
- Post-New HTC Staff Orientation Update
- Upcoming Meetings
by Marketing & Operations Team
We were very excited to return to New York City this past March for our New HTC Staff meeting. We got to see many new faces from the Centers, along with a turnout of over 60 attendees – ranging from administrators, nurses, social workers, program coordinators and many others in clinical roles. Although the meeting only lasted a day and a half, our agenda was loaded with valuable information that the attendees could take home and use at their centers.
“It was explained in a simple way and I was able to come out with a much deeper understanding.”
One attendee commented, “I think the best part was being able to network and meet with other HTCs and get to see what other roles and stuff they are working on.”
Alex Kireilis from Mass General Brigham center in Boston also added his perspective as an attendee, “Backed by the support of key sponsors including CSL Behring, Genentech, and Sanofi, the Hemophilia Alliance’s 2024 New HTC Staff Orientation was immensely informative and engaging. The orientation was a well-rounded event beginning with a lively welcoming reception providing a meet and greet opportunity for attendees to network with the Alliance staff, as well as members of other HTC’s around the country. It proceeded to include 2 days of diverse, interactive, and educational presentations. Presenters included the expert leadership staff of the Alliance, individuals with hemophilia, highly regarded HTC staff members, and representatives of the aforementioned sponsors. This lineup of knowledgeable speakers provided education ranging from regulatory requirements of operating an HTC, to the commitment the sponsors have made to the hemophilia space including product development and patient support, all the way down to the importance of advocacy by every individual associated with the HTC’s. This event provided an excellent opportunity to fast-track new HTC staff and in turn infuse added value into their respective HTC’s. Future orientations should be considered invaluable for new HTC staff and a must-attend event regardless of their role.”
We continue to make our meetings as engaging and informative as possible, while keeping an energetic environment for social networking. As a whole, we are excited to carry over the momentum for our meetings in the future, and we hope to see you all again soon!
MEETING | DATE |
---|---|
Physical Therapists CE Conference [ONLY VIRTUAL OPTION IS AVAILABLE] | May 15 – 17, 2024 |
Nurses CE Conference [ONLY VIRTUAL OPTION IS AVAILABLE] | June 10 – 12, 2024 |
Fall Members Meeting [SAVE THE DATE] | October 9 – 11, 2024 |
Physicians and Business Administrators Meeting [SAVE THE DATE] | November 14 – 17, 2024 |
4th National HTC Patient Satisfaction Survey Underway
The Hemophilia Alliance is pleased to promote the 2024 National HTC Patient Satisfaction Survey (PSS), which was developed by HTC Networks and Patient Satisfaction Survey (PSS) Steering Committee, representing the HTCs in the US. This is the fourth iteration of a patient satisfaction survey; the input received from patients and families through past surveys helped HTCs identify areas where they may have strengths and where they need to improve.
The survey should be completed by patients and caregivers that had contact with an HTC in 2023. The survey is open until May 31, 2024 and can be completed online at www.htcsurvey.com.
The PSS Steering Committee has prepared materials that HTCs can utilize with patients to encourage them to participate in the survey. Please contact Eleanor Carrick at carricke@ohsu.edu with any additional questions.