BDANENY December Newsletter

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THE VESSEL The Official Newsletter for The Bleeding Disorders Association of Northeastern New York

December 2020

BDANENY 2020 Annual Meeting Our first (and hopefully last!) Virtual Annual Meeting was held on November 14th. Once again, using the Zoom platform, we were able to bring education, information, and a bit of fun to members in their own homes. The day started with an update of federal legislation, regulation and advocacy from Miriam Goldstein, JD, Policy Director & Principle Legal Counsel for the Hemophilia Federation of America. Miriam explained the importance of several cases currently slated for the Supreme Court, and how they could potentially impact the bleeding disorders community. She also examined the threat of co-pay adjusters; the financial impact on

patients of such rulemaking, and how HFA is monitoring the issue. Although she now works for HFA and is based in Washington, DC, Miriam grew up in the Capital District and graduated from Bethlehem High School, giving her a unique understanding of the issues facing the community in Northeastern New York. Executive Director Beth Mahar gave an update of State legislation, regulation and advocacy as well as a vision for the future of the Association. Touching on Advocacy, Education, Outreach & Support, Personal Development & Recreation, and Continued on p. 2

In This Issue ENTER TO WIN A GIFTCARD! Submit your favorite winter pictures to or tag our Facebook page. Two Drawings will be held on Friday, January 15th:

Farewell to 2020

Unite for Bleeding Disorders Virtual Walk

Legislative & Regulatory Update

Industry Update

Best scene!

Resources for Help

Best people pic!

Scholarship Applications

Upcoming Events

Continued from page 1 Fundraising – all pillars of our Association Charter- we discussed how each of these vital components could be promoted and enhanced in 2021 and beyond.

we WILL do! If you missed it, you can still view the slide show here.

Capping off the morning, Jean Marandola, Senior Clinical Educator, Takeda Pharmaceuticals, talked And since the Annual Meeting with us about supporting women in landed smack in the middle of this the bleeding disorders community – year’s virtual UNITE Walk, we both as patients and as caregivers. wanted to get everyone in the audi- Women with bleeding disorders ence inspired to participate, in face unique challenges that are ofwhatever way was expressive to ten unrecognized or underapprecithem. To inspire and encourage ated. Jean encouraged us to underthose couch-sitters out there, we stand some of the special challengshowed a retrospective of past es faced by women with bleeding walks, as a reminder of what we disorders and identified options for can do, what we could do and what

emotional support within the community. Periodically throughout the meeting, we played a web-based trivia game to enhance (and have fun with) the audience’s knowledge of hemophilia and von Willebrand’s disease. The top scorers went into a lottery for our Grand Prizes, a day at Spa Mireval and a day at the Great Escape Indoor Water Park. Everyone who participated got a “swag box” courtesy of our friends in the pharmaceutical industry.

In order to do good FOR the community, we rely on goodness FROM the community. In this season of giving, we extend a special thanks to our donors: Charles Leitzell Joseph Brennan Cathy Brennan John J Enterprises 2

A Word from the Executive Director The close of every year brings the opportunity to reflect on the good, the bad and the ugly. I’m sure you’ll all agree that there’s been plenty of ugly in 2020 – and plenty of bad too! But at the risk of outing myself as an eternal optimist, there some wonderful things have happened in 2020 that are worth celebrating. Coronavirus vaccines represent an unparalleled scientific advancement. These vaccines appear to have very high levels of efficacy and safety, and they can be produced more quickly than more conventional vaccines. The Moderna vaccine mRNA was designed in two days, and without access to Covid-19 itself, a remarkable achievement. For the past several years, researchers have been working on new ways to develop vaccines. The success of the coronavirus vaccines is a major vindication of that work and a really good sign of how well it could work for other diseases. We have learned important lessons in how to fight a pandemic. In 2009, I worked with the Hospice Association on a Department of Health grant to design a triage system for ventilator allotment in the event of a pandemic. Fortunately, matters never got that extreme – this time around. Scientists have been warning of a pandemic for years. This coronavirus has certainly exposed the cracks in our health care system, but we can learn from this, and do better next time.

We have learned who “essential workers” truly are and have become more appreciative of the role they play in the day-to-day functioning of our society. Beyond health care workers, who deserve all the accolades and recognition our nation can bestow, janitors, grocery store clerks and truck drivers have been recognized as performing key roles. No one gets more love than the guy who unloads a pallet of Lysol wipes at Sam’s Club! Outside the pandemic, the murder of George Floyd in May proved a catalyst in raising voices who demand a fairer, more equitable and kinder society. It forced global public attention to focus on the realities of discrimination and racism. And finally, 2020 was the year that I joined the BDA. I’m excited to be working with this dynamic and caring community. We’ve gotten off to a great start in the last few months and I’m confident that we will continue to build on our success in 2021.

Taking a moment to acknowledge good things is important for building resilience and maintaining perspective. Perhaps that’s the most important lesson that 2020 can teach us. I wish you and yours a happy and healthy new year!

2020 has made us more grateful. A survey, commissioned by Groupon, polled 2,000 people from around the United States to find out how the pandemic and other events have impacted holiday gifting trends. They found 70% of those surveyed to be even more appreciative of family and friends than they were at the start of the year. 3

Do You Need Help? Living with a bleeding disorder can be a substantial financial burden. The pandemic has made things worse. While the Coronavirus economic aid bill, signed by President Trump on December 27, will provide a $600 stimulus check to those earning less than $75,000, an estimated 870,000 New Yorkers remain unemployed. Where can you turn for help? Hemophilia Federation of America (HFA) offers several programs for people with bleeding disorders:

Grifols: support-and-resources/factors-for-health Medexus: Custom Ancillaries (Supplies at no charge); IXperience Concierge Novo Nordisk: Product Assistance; Co-pay assistance Octapharma: Nuwiq; Wilate Pfizer:

Helping Hands Emergency Assistance Program helps with housing, utilities and transportation. Helping Hands Item Assistance Program helps with medically necessary items that are not covered by insurance. Helping Hands Inhibitor Support Program provides a safety net for families affected by inhibitors.

Sanofi/Genzyme: Alprolix; Eloctate

COVID-19 Relief Fund provides financial relief for those experiencing a significant loss of income due to COVID-19 Disaster Relief Fund helps community members who are displaced or impacted by a natural disaster

Patient Services, Inc. Assistance with co-pays and premiums; currently at capacity, but check back monthly

Pharmaceutical Corporations: Many pharmaceutical companies offer co-pay and insurance coverage support. Bayer: Jivi, Kovaltry, Kogenate CSL Behring: support-and-assistance Genentech: Hemlibra, Genentech Patient Foundation

Takeda: Other Resources:

PAN Foundation: Assistance with out-of-pocket costs

Colburn Keenan Foundation: The Foundation’s individual grants are meant to help individuals and families meet their urgent medical, basic survival, and quality of life needs. Social Services Supports Supplemental Nutrition Assistance Program: Incomebased monthly benefit used to purchase food https:// HEAP: Help paying for your energy bill https://

SAVE THE DATE! Albany Days will be held virtually March 20—23, 2021 4


Legislative & Regulatory Update el, first floated in 2018. Instead of paying solely based on manufacturers’ average sales price (ASP), Medicare will pay based on a blending formula that includes the lowest adjusted international price, (the “MFN Price”) for the drug.

Supreme Court The U.S. Supreme Court heard oral argument on November 10 the lawsuit over the constitutionality of the Affordable Care Act, California v. Texas. Many who listened to the hearing feel cautiously optimistic that a majority of the Court may lean toward upholding the ACA, however, no decision is expected in the case until 2021. The Supreme Court has handed down a ruling in the case of Rutledge v. PCMA. The issue was whether a state (Arkansas) can impose regulations on health plans covered by ERISA (Employee Retirement Income Security Act – i.e. the body of laws that regulate employee benefit plans). The Court ruled that the Arkansas law regulating PBMs is not preempted by ERISA. This opens the door to potential further state regulation of PBMs and employer-provided health plans. Federal Legislation Congress included the provisions of the Hemophilia SNF Access Act in HR 133, the Consolidated Appropriations Act of 2021, which means that starting on October 1, 2021, skilled nursing facilities will be able to bill separately for bleeding disorders treatments provided to Medicare beneficiaries. Congress passed the bill on December 21 and it was signed by President Trump on December 27.

Clotting factors and some other products used to treat bleeding disorders are Part B medicines, but they are not currently included in the rule’s list of medicines that would be subject to the MFN model. The MFN plan is drawing legal challenges from drug manufacturers and others, on both procedural and substantive grounds. On December 23, 2020, the U.S. District Court for the District of Maryland issued a temporary restraining order which temporarily restrains HHS from implementing, enforcing, or otherwise effecting the Most Favored Nations Rule for a period of fourteen days. Rebates Another rule takes aim at drug rebates paid by manufacturers to pharmacy benefit managers in Medicare Part D. This rule seeks to force Pharmacy Benefit Managers (PBMs) and health plans to pass along those rebates to patients at the point of sale. Like the MFN rule, the rebate rule may be vulnerable to challenge. Enhancing Protections to Value-Based Care Plans A third final rule revises federal safe harbor rules that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. The final rule offers more flexibility to arrangements where parties assume more financial risk. Notably excluded from the definition of Value-based Entities – and therefore unable to access these new protections - are laboratories, pharmacies and PBMs.

The Trump Administration also released a longawaited final regulation on the Alternative Dispute Federal Rulemaking Resolution (ADR) process in the 340B Drug Discount The Trump Administration released three separate, Program (340B Program). The final rule is effective long-pending, drug pricing rules on November 20 as January 13, 2021. Under the new rule, ADR is limited the Administration is seeking to beat a 60-day deadto disputes between covered entities and manufacturline for finalizing the rules before President-elect ers involving claims of $25,000 or higher. The dispute Biden’s inauguration. resolution board would consist of at least six members appointed by the HHS Secretary with equal numbers Most Favored Nation Pricing from the HHS’ Health Resourcs and Service AdminOne plan would link Medicare Part B payments for 50 istrtion, the Centers for Medicare & Medicaid Serdoctor-administered medicines to lower prices paid vices, and the HHS Office of the General Counsel. overseas - the so-called “Most Favored Nations” modContinued p. 7 6

Legislative & Regulatory Update (cont.) Medicaid Plans CMS issued a long-awaited final rule that gives states greater flexibility to set standards for Medicaid manExchange Plans aged care plans, especially as relating to network adeFederal regulators (CMS) finalized health insurance quacy, payment rates, plan oversight, and shortening transparency regulations that for the first time require the time periods for beneficiaries to appeal denials. both group and individual plans to disclose whether The rule followed many of the recommendations from they are applying cost-sharing assistance that conMedicaid directors and hospital groups who had comsumers receive from third parties to that consumer’s plained that the landmark standards CMS put in place annual cost-sharing obligations. in 2016 were too burdensome and proscriptive. Most of the changes went into effect December 14. Over On November 25, CMS released its annual “Notice of 85% of NYS’s Medicaid plans are managed care Benefit and Payment Parameters” for 2022 health plans. plans. While versions of the NBPP in past years have set out rules addressing health insurers’ use NYS Legislative Update of accumulator adjusters, the current rule makes no NYS Legislature will convene a special session to mention of accumulators. discuss revenue generation, as Congress has not been able to agree on any kind of aid measure. The latest COVID relief bill does not include any aid to states. Health Insurance Plans


BDANENY 2021 SCHOLARSHIPS Are you a high school senior who plans to attend a vocational school or undergraduate program? The cost of a higher education increases every year, yet in today’s world, a degree is increasingly necessary. At the BDA, we are here to help. The Association designates funds for the higher education of its members at accredited vocational schools and undergraduate programs. Applicants must be individuals with or immediate family members of individuals with a congenital bleeding disorder and be dues-paying members of the Association. One award will be granted per year for members living within the same immediate household. Depending upon available funds and the degree program in which enrolled, the BDANENY will award up to two $1000 scholarships per academic year. Applications must be submitted on or before March 15, 2021.

Click here to download an application and click here to download the rubrics used for evaluating each scholarship.

2020 UNITE Your Way Virtual Walk The coronavirus pandemic has forced all of us to get creative in all areas of our lives. Our annual walk to UNITE for Bleeding Disorders was no exception. Instead of gathering in a large group (so 2019!), our “walkers” took on the challenge of “walking” in their own way. Teams launched fundraising activities such as yoga, biking, Peleton-ing and wreath-making, in addition to the traditional walking, to support the NENY bleeding disorders community. Our event kicked off on October 10 and closed on December 4, and during that time, our teams raised over $10,500! Since our sponsors couldn’t be there at the roadside to cheer us on, they instead provided us with virtual “water breaks” along the way, opportunities to recharge, refocus and pull the team over the finish line. These creative activities included:

Cooking with Chef Mike Sponsored by Novo Nordisk and BioMatrix, this laid-back evening showcased the talents of Chef Mike as he walked us through the preparation of hand-held chicken pot pies. Some folks followed along, but some (like me) chose to watch and take notes. Chef Mike was fun and engaging and showed us how easy it was for even a novice to elevate a classic dish. I have since tried his recipe, and it was as easy as it looked – and twice as delicious as any pot pie I’ve made!

Paint & Sip Sponsored by CSL Behring, this craft-based evening taught participants how to use a stencil and paint to create beautiful vintage-look wood signs. Our crafters were given the choice of 3 different “sayings” for their sign and a choice of two background colors. Participants brought their creativity and willingness to learn to create a wooden sign piece worthy of any wall. Each project was unique and beautiful!

K-Taping Sponsored by Cottrill’s, this interactive session with Dr. Mike Zolotnitsky showed us how to correctly use K-tape to prevent joint bleeds. Also called kinesiology tape, Kinesio tape, or KT, k-tape is an elastic cotton strip with an acrylic adhesive used to treat pain and disability caused by athletic injuries or other physical disorders. Using this helps control pain and support weak muscles. It provides the support of a brace, but with the flexibility to prevent limited range of motion and reduce muscle contractures.

2020 UNITE Your Way Virtual Walk—THANK YOU!!! We want to extend a big thank you to our teams: Trish’s Trekkers The Bruizers Clot Hoppers Finding Hemo The Blood Brothers BlEEDers VW Venturers Buggy’s Bleeders The Sanofi/Genzyme Corporate Team And another sincere thank you to our Sponsors: Gold Sponsors: Novo Nordisk CSL Behring

Silver Sponsors: Cottrill’s BDRN

Kilometer Sponsor: BioMatrix

National Sponsor: Takeda


Contact Us BDANENY Office 333 Broadway Suite 320 Troy, NY 12180 (518) 729-3577

BDANENY Board of Directors and Staff President…………………….…………..…Bruce Weiner Treasurer………………………………….....Cindi Keeler Board Member……………….……………..Bill Brownell Board Member……………………...…....…Dave Huskie Board Member…….……………..Christina Mastrianni Executive Director……………..…….….…..Beth Mahar Operations Manager………………....Patricia Bengraff Administrative Assistant……….……......Melissa Deeb

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