Notes from Joe
Finally, and thank you!
by Joe Pugliese
A little more than a year after the worldwide recall of Stimate, there is cGMP manufactured DDAVP NS available in the USA. The product is being produced and distributed by STAQ Pharma, a registered 503B Outsourcing Facility. They shipped 57 vials on Monday, 9/13/2021. They are presently able to ship into 31 states across the country (see map) and are working on getting licensed nationally. This product was made possible because the Alliance Board of Directors funded its upfront development costs. Additionally, a limited number of vials are available through the DDAVP challenge program. The product will only have about 70 days dating when you get it. Subsequent lots will have increasingly longer dating.
The product is listed on First Data Bank, Medispan and Redbook. United Healthcare has said they will reimburse under UHC and OptumRX Commercial Plans and UHC Community Plans (Managed Medicaid in states where UHC controls the formulary) and Missouri Medicaid has indicated they will reimburse for the product. The Alliance payer team, and the Advocacy teams at the National Hemophilia Foundation and the Hemophilia Federation of America have all been working together so the product is covered. We have notified commercial pharmacies and PBMs including CVS/Caremark, Express Scripts, Optum and numerous smaller regional and local home care providers that the product is available. The pharmacies need to set up an account with STAQ Pharma, the point of contact is firstname.lastname@example.org. If your pharmacy is not aware that the product is available, please share this newsletter with them.
On the policy front, I want to say thank you to Reps. Abigail Spanberger (D-VA) and David McKinley (R-WV), who have introduced bipartisan legislation called the Protect 340B Act. We were joined by the NHF advocacy team on a call with Rep. Spanberger’s health aide to discuss the bill and its many pros and few potential cons. Our goal is to support the provisions that would prohibit payers/PBMs from interfering with patient choice and imposing discriminatory pricing for covered entities. We see all the time when patients/families are not able to choose their pharmacy provider, and we support efforts to prohibit that practice. But, we also want to ensure that these protections don’t inadvertently make it more difficult for HTCs to get into network. What we would like to see prohibited is for PBMs and health plans to be able to cut in our discount. NHF has long had the position that each plan includes at least one commercial provider and 340B providers, who are providing the patient’s clinical care.
The bill also takes aim at discriminatory, and arbitrary attempts to exclude HTCs from networks. Things like multiple accreditations that simply drive-up costs without improving outcomes. Another favorite tactic is the requirement to carry a variety specialty. Why would a bleeding disorders center carry cancer drugs? Finally, there is the exclusive contract pharmacy arrangements, where the PBM assures the employer or the health plan that they can only offer the best pricing and on all the drugs. If you want to carve out hemophilia products and save 25- 30%, they will raise your price on everything else.
We applaud the effort and will do everything in our power to help this critical piece of legislation get enacted. If you’d like to join us in advocating for the bill, please let me know and we can provide you with the information you need.
Reorganization of HRSA and Change in Office of Pharmacy Affairs Leadership
by Elizabeth “Issie” Karan
At the end of August, the Biden Administration released a notice in the Federal Register regarding the reorganization of the Health Resources and Services Administration (HRSA), including the 340B Program. The Office of Special Health Initiatives (OSHI) now will oversee the 340B Program and the Office of Pharmacy Affairs. Additionally, Rear Admiral Krista Pedley will no longer directly oversee the 340B Program because she is slated to be promoted to the inaugural Director of OSHI, which has not yet been publicly announced.
According to information on the HRSA website, OSHI provides a crosscutting focal point for HRSA to deliver on population health and Secretarial priorities, especially those that may be more clinical in nature. Specifically, OSHI: (1) coordinates and collaborates with components in HHS that align with the work of OSHI; (2) serves as the principal advisor within HRSA on global health issues; (3) provides agency-wide leadership and policy development in the administration of the 340B Drug Pricing Program to promote access to clinically and cost effective pharmacy services to the country’s most vulnerable patient populations; (4) serves as the lead on behavioral health issues that span HRSA; and (5) provides cross-cutting leadership on HRSA oral health programs.
OSHI is more closely connected to the Office of the Secretary of Health and Human Services. Theoretically, this could signal HHS’ priority to monitor the 340B Program more closely and/or coordinate its impact across the Department. The Hemophilia Alliance will continue to monitor developments in the 340B Program’s structure and leadership.
by Johanna Gray
We’re in the midst of another very busy September in Washington! Here’s the latest:
- Federal funding: Congress has to pass legislation to fund the government by the October 1, 2021 start of fiscal year 2022. They are likely to pass a continuing resolution (CR) to fund the government at current levels to give them more time to negotiate year-long spending bills. The funding extension is being paired with a policy to raise the debt ceiling (the US is estimated to hit our current ceiling in October). If Congress does not pass a CR, then the government could shut down.
- Reconciliation package: Democrats in Congress are also hard at work on the Build Back Better reconciliation package that is the “human” infrastructure package to be combined with the Bipartisan Infrastructure Framework (“hard” infrastructure package) that the Senate passed last month. While there appears to be consensus about some important coverage expansions included in the bill, there remains a lot of uncertainty about whether any drug pricing provisions will be included. As of this writing, there are no provisions relating to 340B reform. We have successfully worked with our colleagues in the 340B Coalition to prevent inclusion of a provision that would have states reimburse for 340B drugs the same in Medicaid managed care as for fee-for-service.
- Protect 340B Act: As mentioned above in Notes from Joe, the Alliance is supportive of the Protect 340B Act. If you would like to advocate with your members of Congress in support of the bill, please contact me and I can provide you with a template email and contact info for the right staffers.
- Hemophilia SNF Access Act: The new ability for skilled nursing facilities (SNFs) to bill separately for bleeding disorders treatments takes effect on October 1st. The Alliance and NHF are both working on materials to be provided to SNFs, HTCs, chapters, and patients about the new law and how it will be implemented. Stay tuned for more info on this!
Open Enrollment Beginning
by Jeff Amond
Health Insurance Open Enrollment season has begun. Now is a great time to begin preparing and contacting your patients about their 2022 health insurance to determine if there will be changes that may impact the clinical and pharmacy services you provide.
Monday November 1st kicks off the open enrollment period for the ACA marketplace plans, which goes 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 year that will lower premium and out-of-pocket costs for many people seeking insurance on the ACA marketplaces. For many patients, it will pay to shop around. Given the time frame to enroll and the premium changes, we encourage you to contact your patients enrolled on ACA plans to be sure that they reenroll in coverage before the deadline in your state.
Some additional items to consider about the ACA for your patients:
- Even though the ACA Open Enrollment Period is over for 2021, your patient can still enroll in or change a Health Insurance Marketplace plan if they 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). Please see Healthcare.gov for complete details.
- If your patient qualifies for Medicaid or the Children’s Health Insurance Program (CHIP), they can apply anytime.
Some additional items to consider for your HTC include:
- 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 and 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!
- Keep your fingers crossed
by Sean Singh
We have cancelled all of our in-person meetings for the remainder of 2021. While we were hoping to see many of you this year in person we will look forward to seeing you in 2022. We have worked on our schedule for the first few months of 2022 and hope that you keep your fingers crossed that we can get together. We will keep a close eye on how things progress and will update you as soon as we can with information. If there is a conflict with dates of other meetings, please contact Sean. He can be reached at email@example.com or 727-388-7326.
9th to 11th – Board Retreat: Board Only
26th to 28th – Pharmacy CE Conference
6th to 8th – New HTC Staff Meeting
23rd to 25th – Linda Gammage Social Worker Conference
3rd to 5th – Spring Members Meeting
TBD – Hemophilia Alliance Hill Day
TBD – Up and Coming (small centers) member meeting
- Harmony in Hemophilia – HTC Wall of Walkers Unite Walk Challenge Update
by Karen Bowe
Our initiative to enhance relationships between HTCs and Chapters and to increase HTC participation in NHFs Unite Walk program is working! So far, we have 24 HTC teams registered. As the walk season gets into full swing in September and October, we anticipate registrations will continue to increase. As of 9/20/21, we have surpassed what the 2020 HTC teams raised in total and we are just approaching the heart of walk season with most walks happening mid-September to early October!
HTC team registration drive: All HTC teams that are currently registered and/or register by Sept 24th and receive at least one donation of any size will be entered into a drawing of chance to earn (5 winners total)
- Swag Bag w/special Unite for Bleeding Disorders and Hemophilia Alliance items
- (4) $250 cash contributions to their walk team
All teams that participate will be showcased on the NHF Unite Walk HTC Wall of Walkers! Important: Please make sure to take a group picture on Walk Day and submit photo and/or logo to firstname.lastname@example.org
The 5 highest fund-raising teams will receive a $1000 travel scholarship to the 2022 NHF Bleeding Disorders Conference to be held in Houston, TX Aug 25th – 27th. The Hemophilia Alliance thanks everyone for your participation and efforts to benefit your local Chapter.
Notes from the Community
Update from the Hemophilia Alliance Foundation
Congratulations to our 2021 “Innovation Grant” recipients!
Thank you to all of the organizations that applied for the Hemophilia Alliance Foundation’s 2021 Innovation Grant (formerly known as the “Large Grant”). In total, we received nine highly competitive applications for this $50,000 grant, which focuses on high-impact, innovative projects for the inheritable blood disorders community. We are proud to announce the two recipients of the 2021 Innovation Grant: Hemophilia of North Carolina, and the Hemophilia Federation of America!
The Hemophilia Alliance Foundation has completed a long-awaited update of its website! We have the same URL (https://hemophiliaalliancefoundation.org), and our hope is that the new website will be easier to navigate for applicants and grant recipients. A few new features include:
We would love to hear the community’s feedback on our new website! Please contact Grant Hiura, Secretary, at email@example.com if you have any comments/suggestions. Thank you!
Team Alliance Contact Information
We work for you! Please don’t hesitate to contact any of us with any questions or concerns: