In this Issue…
Notes from Joe
· Highlights from Hemophilia Alliance Fall Member Meeting
Alliance Board Update
· Alliance Seeking Board Nominations
Alliance Update
· Texas ‘HOT’ or Not?
· 2024 Meeting Schedules
Washington Update
· CMS Allows Clotting Factor Add-On Payments for Inpatients Coded with New ICD-10 Diagnoses Codes for VWD
· Congress May Stagnate But Regulatory Activity Continues
· Alliance Responds to Request for Information and FDA Guidance
· Court Rules in Favor of Patients regarding Copay Accumulator Adjustor Programs
· Uniform Grants Guidance – New Proposed Rule
Payer Update
· Know Your Patients and Their Insurance
Notes from the Community
· Congratulations to our 2023 “Innovation Grant” recipients!
· Youth Effectively Transitioning to Independence (YETI) Reunion
Highlights from Hemophilia Alliance Fall Member Meeting
by Joe Pugliese, President and CEO
Our recent member meeting was held in San Antonio, TX from October 8th to the 10th. The big news was the announcement that Jeff Blake will be stepping into the role of President and CEO effective January 1, 2024. Jeff will be leading an outstanding team of staff and consultants with over 300 years of experience in the bleeding disorders space.
It was fitting that my last member meeting as President and CEO of the Alliance was in San Antonio, the same location, where in 2008, I began my term. Prior to the 2008 meeting, there were two organizations with two separate boards that functioned as the Alliance – the Hemophilia Alliance, a 501(c)6,member organization and the Hemophilia Alliance Group Purchasing Organization, a 501(c)3, group purchasing organization (GPO). At the 2008 meeting, the two organizations merged. The Hemophilia Alliance became a 501(c)3 organization filling both the GPO and membership organization roles (More on this story in my last Notes from Joe in December).
The Fall Meeting was outstanding. Sean and his team did their usual great job. The meeting participants appeared to truly enjoy being together and sharing ideas on how to improve their operations, always with the focus on improving patient outcomes. Thanks go to the excellent presenters, whose slides are available in the members section of the Alliance website.
I want to take note of two highlights from the meeting. The first was not even a presentation but Eric Gray, the Alliance Board Chair, asked all the meeting attendees to recite the organization’s mission statement inserted here. It was a remarkably powerful way to bring our work into focus.
The Hemophilia Alliance works to ensure member Hemophilia Treatment Centers have the expertise, resources and public support to sustain their integrated clinical and pharmacy services for individuals with bleeding and clotting disorders.
The second highlight for me and the meeting attendees was a presentation by Jamison Buxton CEO and Andrea Miller, APNP of Hemophilia Outreach Center (HOC) – Green Bay, WI, who presented on their center’s experience providing gene therapy to two patients. HOC was the first center in the US to infuse a commercial gene therapy product outside a clinical trial. What made the presentation so special was the obvious attention to every detail, the thoughtfulness, obvious compassion, and commitment to doing it right.
I am also pleased to report that the Alliance, along with NBDF, HFA and Coalition for Hemophilia B continue to work together to further the ability of HTCs to serve the bleeding disorder community. We recently sent letters to the state Medicaid offices in Florida and Arizona seeking the inclusion of HTCS in network for both clinical and pharmacy services under Medicaid, rather than their existing exclusive relationship with a single PBM. We plan on sending similar letters to other public and private payers.
I think the secret superpower of the USHTCN is their passion and dedication for doing the right thing for their patients. I know it is what has made my work in this community for the last 45 years so enjoyable.
Alliance Seeking Board Nominations
by Becky Burns, Vice Chair, Hemophilia Alliance Board
The Hemophilia Alliance Board Nominating Committee is seeking applicants or suggested nominations to fill vacancies on the board of directors. For consideration by the nominating committee, applicants are to submit a letter of interest and resume or CV to becky@ilbcdi.org by Friday, November 24, 2023. We seek to broadly represent our membership and are encouraging applicants from all regions and disciplines to apply.
Applicants or suggested nominees must be employed by a Hemophilia Treatment Center in good standing with the Hemophilia Alliance, support the Hemophilia Alliance mission, vision and programs, and be willing to share their knowledge and expertise with the Hemophilia Alliance, participating in bi-monthly board meetings.
Terms are for a 3-year period, not to exceed 2 consecutive terms. In a typical year, the Board meets six times per year, three via conference call and three in-person. Two of the in-person meetings occur at the Hemophilia Alliance membership meetings and one board retreat takes place in January.
Our Mission
The Hemophilia Alliance works to ensure member Hemophilia Treatment Centers have the expertise, resources and public support to sustain their integrated clinical and pharmacy services for individuals with bleeding and clotting disorders.
Our Vision
Through the work of the Hemophilia Alliance, the clinical and pharmacy programs of the Hemophilia Treatment Centers are integrated, stable and sustainable within a changing healthcare environment. They are trusted and respected as the preferred way to provide people with hemophilia and other bleeding disorders access to the full range of care they need.
For more information about the Hemophilia Alliance visit our website hemoalliance.org.
FAQs
What does it cost to be on the board?
There is no cost to be on the board.
When does the board meet?
Two in person meetings occur at the Hemophilia Alliance membership meetings, one board retreat takes place in January and three conference calls take place on the fourth Thursday of the month at 2pm EST.
What are the qualifications or degrees needed to be on the board?
You must be employed by the HTC and in good standing with the Hemophilia Alliance with previous committee or board experience. No other qualifications or degrees are needed.
Do I need to hold a particular role in the HTC?
No.
Does my program have to be a large program to be on the board?
Candidates from all types of centers from new startup centers to well established programs are encouraged to apply.
What are some of the things I should include in my letter of interest?
- Your role with the factor distribution program.
- Things that interest you in serving on the Hemophilia Alliance board and what you feel you will bring as a member of the board.
- Include your experience with local, regional, national committees or boards related to hemophilia and related bleeding and clotting disorders.
If you have any additional questions please feel free to contact me at becky@ilbcdi.org.
- Texas ‘HOT’ or Not?
- 2024 Meeting Schedules
by Marketing & Operations Team
We know we all just finished unpacking our bags from the 2023 Fall Members Meeting, but we wanted to briefly say how amazing it was to see those of you who could attend in San Antonio, TX. We got feedback that the gorgeous St. Anthony Hotel provided a beautiful atmosphere for networking, so now we need to make sure all future meeting locations have beautiful sunsets and a rooftop terrace.
The BINGO was a great hit to create some fun and stay engaged. We were super excited that we had 30 attendees who won prizes! While we all experienced great swings in the room temperature, we also want to give a big shout out to the amazing guest speakers and room moderators who managed to stay cool under pressure. We really tried to keep presentations to 30 minutes to help keep content concise and we received comments that this helped maintain meeting flow. Additionally, we will continue to do breakout sessions at future meetings, but we want to hear YOUR ideas for topics, and we want these sessions to include more open round table discussions. If you have not already done so, please take the time to complete our Day 1 and Day 2 meeting surveys. We so value each person’s feedback and do our best to implement your thoughts and ideas!
To keep the fun going, the dinner at the Buckhorn Saloon provided endless entertainment and wonderful food. We heard that everyone had a ‘hoot and the food was delicious’ and some of the local attendees were even impressed!
| MEETING | DATE |
|---|---|
| Board Retreat Pharmacist CE Conference [REGISTER NOW] |
January 7 – 9, 2024 January 24 – 26, 2024 |
| Linda Gammage Social Worker CE Conference [REGISTER NOW] | February 28 – March 1, 2024 |
| New HTC Staff Orientation [REGISTER NOW] | March 25 – 27, 2024 |
| Spring Members Meeting and Hill Day | April 15 – 18, 2024 |
| Nurses CE Conference | June 10 – 12, 2024 |
| Physical Therapist CE Conference | August 12 – 14, 2024 |
| Fall Members Meeting | October 9 – 11, 2024 |
| Physicians and Business Administrators Meeting | November 13 – 17, 2024 |
- CMS Allows Clotting Factor Add-On Payments for Inpatients Coded with New ICD-10 Diagnoses Codes for VWD
- Congress May Stagnate But Regulatory Activity Continues
- Alliance Responds to Request for Information and FDA Guidance
- Court Rules in Favor of Patients regarding Copay Accumulator Adjustor Programs
- Uniform Grants Guidance – New Proposed Rule
by Ellen Riker, Artemis Policy Group, Hemophilia Alliance Advocacy Consultant
In a Medicare Learning Network newsletter released on Oct 19, CMS notified providers that Medicare’s policy for allowing separate payment (outside the bundled hospital DRG payment) for blood clotting factors and other treatments provided to inpatients with Hemophilia would also apply to patients with any of the new VWD Diagnoses Codes. As a reminder, new diagnoses codes for VWD were approved by CMS and CDC and became effective October 1, 2022. The update states that the Medicare Administrative Contractors (MACs) must adjust claims already processed for treatments provided as of 10/1/22 for any of the clotting factor J-codes for patients with any of the new VWD diagnoses codes. The update can be found at: MM13381 – Update for Blood Clotting Factor Add-on Payments (cms.gov) and the CMS Manual update can be found at: r12290cp.pdf (cms.gov).
by Artemis Policy Group, Hemophilia Alliance Advocacy Consultants
The 118th Congress continues to bring unprecedented events – the first ousting of a Speaker of the House of Representatives in history has been followed by an inability to elect a new Speaker. Unlike at the beginning of the Congress, the House can proceed with business (as Members already have agreed upon the rules under which they will operate). However, congressional business has slowed significantly and the timing could not be worse.
The House turmoil comes just after the government narrowly averted a shutdown by passing legislation, known as a continuing resolution, which extends fiscal year 2023 funding levels for federal agencies and programs until November 17, 2023. To complete the appropriations process for fiscal year 2024, Congress must pass twelve bills before the November deadline. If Congress fails to act by November 17, we once again face the threat of another shutdown or Congress must pass another short-term continuing resolution to buy more time.
Energy and Commerce Request for Information on Drug Shortages: The Alliance submitted a letter in response to the draft legislation on drug shortages under consideration by the Committee. We supported the bill’s provision to facilitate the use of 503B compounding facilities to meet patient needs during drug shortages. We also encouraged the Committee to consider enacting a policy to waive annual fees for manufacturers creating products to address drug shortages. Giving DDAVP as an example, we explained that the costs are prohibitively high, which results in high prices for patients.
Comment Letter to FDA on Draft Guidance for Industry: Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act: The Alliance, along with NBDF and HFA submitted a comment letter to FDA in support of its guidance regarding the regulation of 503B facilities. We shared our recent experience with the recall of the Ferring Pharmaceuticals product, Stimate and the work with STAQ Pharma to fill in the gap. The letter states,
“This experience underscores the importance of products produced by 503B facilities. Often, the 503B is the only source for needed medications in proven shortages or total non-availability in the US. Since 503B facilities are required to follow Current Good Manufacturing Practice regulations (cGMP), and they are inspected to that standard by the FDA, quality assurance is ensured, where it may not be in compounded products. There is also a proven expiration date available to licensed dispensing agents who are regulated in each state. In the case of the DDAVP nasal spray, there are also additional specific quality control measures and dating, including the cGMP requirements regarding droplet size and droplet distribution insuring proper dosing for the patient.”
On September 29, the United States District Court for the District of Columbia ruled that insurers can no longer implement copay accumulator adjustor programs (CAAPs) for drugs that lack generic equivalents. CAAPs essentially disallow copay assistance from counting towards a person’s out-of-pocket maximum or deductible, increasing patients’ costs. While the court ruling is a significant positive step forward, additional guidance from the Biden Administration is needed for implementation and enforcement of the policy.
The Alliance advocates against the practice of CAAPs and supports the Help Ensure Lower Patient (HELP) Copays Act (H.R. 830/S. 1375). In addition to banning the practice of CAAPs, this legislation would address copay maximizers (or the “EHB Loophole”), another practice by insurers that results in patients paying more for their vital treatments by carving them out of the essential health benefits (EHB).
Because the court ruling does not address everything in the bill, the legislation likely is still necessary. The Advocacy team will continue to monitor implementation of the court ruling and update the community accordingly.
The Office of Management and Budget (OMB) recently released proposed revisions to the Uniform Grants Guidance (UGG) with which HTCs must comply. In the press release describing the Proposed Rule, the White house described the changes as a “fundamental rewrite” of the UGG. However, the preamble to the proposed rule states that, except in cases where OMB proposes edits for consistency with statutory requirements, they generally sought to maintain the existing content of the UGG. Additionally, OMB seeks to reduce agency and recipient burden, clarify sections that recipients or agencies have interpreted in different ways; and rewrite applicable sections in plain language, improving flow, and addressing inconsistent use of terms. Comments are due by December 4, 2023. Additional information on the Guidance was presented by Mike Glomb at the Fall meeting. His slides can be found on the Alliance website.
Know Your Patients and Their Insurance
by Jeff Amond, Director Member & Community Relations
Health Insurance Open Enrollment season has begun. Now is a great time to begin preparing and contacting your patients about their 2024 health insurance to determine if there will be changes that may impact the clinical and pharmacy services you provide.
Wednesday, November 1st 2023, kicks off the open enrollment period for the ACA marketplace plans, which lasts until January 15th in most states (it can be as early as December 15th in some states that run their own exchanges). While there remains a lot of uncertainty in the health insurance market, Congress has enacted some important policies during the last few years that will lower premiums and out-of-pocket costs for many people seeking insurance on the ACA marketplaces. For many patients, it pays to shop around. Given the time frame to enroll and the premium changes, we encourage you to contact your patients enrolled in ACA plans to be sure that they reenroll in coverage before the deadline in your state.
What to know about enrollment in ACA plans and Medicaid and CHIP:
- If any patients have a life event that qualifies them for a Special Enrollment Period or if their household income is below 150% of the federal poverty level (FPL) they can still enroll or change their Health Insurance Marketplace plan. Please go to Healthcare.gov for complete details.
- If a patient qualifies for Medicaid or the Children’s Health Insurance Program (CHIP), they can apply anytime.
Additional items to consider in assisting your patients:
- Do you have a solid process in place to track your patients’ insurance?
- Do you know if their insurance is a fully insured or self-insured plan?
- Do you know if your Pharmacy Program can dispense clotting factor?
- Do you need the support or assistance from the Hemophilia Alliance to enhance your Pharmacy Program and Insurance Contracting efforts?
The Alliance Team is here to help. We have developed a Patient Insurance Tracking Spreadsheet and Insurance Questionnaire to assist in your efforts. Please contact one of the Alliance Team Members to discuss how we can assist you in your Payer Relations and Insurance Contracting efforts and always remember – We Work for You!
- Congratulations to our 2023 “Innovation Grant” recipients!
- University of Colorado Hemophilia and Thrombosis Center – Their project aims to develop a physical therapy home program designed to improve ankle proprioception in persons with bleeding disorders. Loss of ankle proprioception has been implicated in playing a role in the repetitive bleeding cycle in persons with hemophilia.
- Western Pennsylvania Bleeding Disorders Foundation – This is a collaborative project between Western and Eastern Pennsylvania Bleeding Disorders Foundation. Their project aims to provide an outreach program to women with the potential to menstruate, providing education on bleeding disorders in women. The project plans to collaborate with local college centers, school nurses, county health clinics and OB/GYNs.
- New England Hemophilia Association (NEHA) – For this project NEHA will be working with the Bleeding Disorders Substance Use and Mental Health Access Coalition (BD SUMHAC) which was founded in 2022 with the mission to advocate for equitable access to appropriate substance use and mental health treatment facilities for all individuals with bleeding disorders. Currently, persons with bleeding disorders who require infusion therapy have for many reasons been denied access to appropriate substance use and mental health treatment facilities, particularly inpatient facilities. Since its founding, BD SUMHAC has demonstrated significant progress in this area working on the state level within five participating states. This grant aims to expand BD SUMAC’s advocacy activities to other states and on the federal level.
- Youth Effectively Transitioning to Independence (YETI) Reunion
by Ralph Gruppo and Amy Marquez, Hemophilia Alliance Foundation
The Hemophilia Alliance Foundation is excited to announce this year’s recipients of the Innovation Grant! Thanks to the Hemophilia Alliance and The Alliance Pharmacy for their support and generous donations, we were able to again award three organizations with $50,000 each to fund their innovative grants.
Congratulations to:
We’re excited to see how these projects take off! Thanks to all of the organizations that applied for this year’s Innovation Grant. It’s great to see all of the passionate ideas people have to help improve the lives of patients with inherited bleeding and thrombotic disorders.
by Madonna McGuire-Smith, Executive Director, Pacific NW Bleeding Disorders (PNWBD)
On Thursday, August 17, about 60 people gathered in the Lobby at the Bleeding Disorders Conference in National Harbor, MD for a Youth Effectively Transitioning to Independence (YETI) reunion event. All attendees were given a chance to mark their place on a US map with a butterfly needle – the butterfly needles were a big hit! The event was a great opportunity for people to reconnect that have attended YETI previously and for those who wanted to learn more about YETI so they can attend in the future. It was great to see HTC staff, local bleeding disorder organization staff and some of our previous teen participants. We are very thankful for the support of The Hemophilia Alliance in helping to make the reunion happen.
YETI is a national conference hosted at a camp nestled in the forest just outside of Portland, Oregon. YETI supports the development of bleeding disorder specific teen programming. The conference brings together HTCs, local bleeding disorder organizations and community members for a weekend long experiential train the trainer program. The conference is split into two tracks, a teen track and an adult track. The adult track consists of HTC and local bleeding disorder organization staff that spend the weekend going through a teen program, while along the way stopping and discussing the best ways to develop an effective and safe program. The teens get to experience a teen only track, meeting other teens from around the country, discussing leadership opportunities and learning what it takes to create a program in their home state. Throughout the weekend both tracks get to intermingle and learn from each other. The YETI conference is entering its eight year in 2024. More than 250 participants from local bleeding disorder organizations and HTC’s across the country have attended. More than 105 bleeding disorder entities have been trained through participation at YETI. More than 24 bleeding disorder teen programs have started or been enhanced as a result of YETI. Nearly 1600 people have been impacted, either directly by participating in YETI or indirectly as a result of someone being trained at YETI.
Registration for YETI 2024 opened October 2. All HTCs are encouraged to contact their local bleeding disorder organization to find out more about putting a team together to attend YETI. To register, go to: https://form.jotform.com/PacificNorthwest/YETI2024adult. The registration requires the HTC and local organization person register at the same time so be sure to contact your local bleeding disorder organization. There have been a large number of early registrations so don’t delay in getting registered – there is a limit to how many people can attend YETI. You don’t want to miss out on all the fun!!
YETI 2024 will be February 22-25th. For more information, please go to https://pnwbd.org/yeti/