April 2020 Newsletter

In this Issue…

Notes from Joe
· Fighting Back

Legal Update
· Helping Patients Impacted by COVID-19 through Chapters

Washington Update
· Medicare Home Health Benefit Changes during COVID to Assist Bleeding Disorder Patients

Payer Update
· Coronavirus Policy Changes and Medicaid

Alliance Update
· Social Work Planning Committee Member Needed
· 2020 Meeting Schedule

Notes from the Community
· Hemophilia Alliance Foundation Provides COVID-19 Relief for Patient Assistance
· Update from Hemophilia Federation of America on its Helping Hands Program
· ASH ISTH NHF WFH Guidelines on the Diagnosis and Management of von Willebrand Disease Open for Comment
· Coronavirus (COVID-19) and Hemophilia Summer Camp Considerations

Team Alliance Contact Information

Notes from Joe

Fighting Back
By Joe Pugliese

The many of us who are sheltering in place send out a HUGE thank you to the many who are out there everyday, taking care of the sick, protecting the elderly, making sure there is food to eat and the lights go on, the mail goes through and the trash is picked up. I guess I am doing my part by not getting sick and causing more work and more strain on those who are trying to take care of all the others who are not so lucky. Sitting at home being safe is very practical but not very satisfying. As was discussed on the webinar last week, there is a current shortage of whole blood and there is a potential shortage of plasma down the road. If you or someone you know wants donate, here are links to finding commercial plasma collection centers and blood donation sites. You can also simply ask Siri or Alexa for blood donation sites near me.

We set up a weekly members webinar every Thursday at 1pm eastern time. We just completed our third webinar and had 186 people register to attend. The Alliance team has done a wonderful job of organizing and presenting during these webinars. Additionally, we have been blessed to have members from HTCs across the country join us to add a boots on the ground perspective. Many thanks to Dr. Roshni Kulkarni, Robert Barto, Cara Hannemann, Amy Schewald, and Elizabeth Bogeman, for their excellent contributions in the last few weeks. All of the webinars have been recorded and are available on the members section of the website. We hope that you will join us this week: our “guest” speaker will be Steve Pipe, MD, University of Michigan Medical Center and the Chair of MASAC. He will be discussing how to prepare to be a gene therapy site. Please be prepared with questions you may have on what to do to prepare your site.

We remain in close touch with our manufacturing partners, all of whom have been very responsive to our requests for timely information regarding availability of product. We are happy to report that supplies remain uniformly very good to adequate. They have also taken the lead on managing inventory to assure that the product is where the need is. We encourage everyone to follow MASAC Recommendation 242 and the supplemental guideline as well.

Two weeks ago, the Alliance Board approved $500,000 in funding for patient assistance. We have already given out $173,000 in financial aid to the Hemophilia Federation of America’s Helping Hands program and 25 Chapters across the country. These grants are only made possible by your support of the Hemophilia Alliance. More details on the grant process is in this newsletter.

We will get through this mess and we all want to be ready when we do. Hope you had a Happy Easter weekend there is no doubt it was the most unusual in our lifetime. Be safe, be well.

Legal Update

Helping Patients Impacted by COVID-19 through Chapters
By Elizabeth Karan

The COVID-19 pandemic continues to have far-reaching economic and health consequences for everyone, including patients with bleeding and clotting disorders and their families. Many Hemophilia Treatment Centers (HTCs) want to support their community during this troubling time. However, as discussed in the legal update in the November 2019 newsletter article, HTCs must proceed cautiously when giving patients support of any kind because of fraud and abuse laws. As such, if HTCS are unable to set up their own programs to support patients in accordance with relevant exceptions to these laws, we recommend working with chapters and other organizations already connected to the community.

HTCs have broad discretion in determining how to fulfill the requirements of their grants and subgrants but must do so in accordance with their grant applications and federal rules. Generally, HTCs must spend funds “to promote and improve the comprehensive care of individuals with hemophilia and related bleeding disorders or clotting disorders such as thrombophilia” (Funding Opportunity Notice, MCHB, 2016). HTCs are allowed to contract with other entities to implement required programming. However, under 45 CFR §75.434, HTCs and other federal grantees are prohibited from making contributions, including and donations, including cash, property, and services, using federal funds.

Given these rules, we recommend that HTCs wishing to implement programming to assist or otherwise provide items of value to patients, work with third parties such as chapters. Such an arrangement should be codified in a contract or other formal document which includes a statement of work, reporting obligations, and/or a budget. HTCs must be able to document that funds were appropriately expended for the purposes of the grant. We also recommend including provisions on term, termination, effective date, and period of performance to ensure all parties understand the duration and scope of the relationship.

If you have any questions or concerns, please contact the Hemophilia Alliance team.

Washington Update

Medicare Home Health Benefit Changes during COVID to Assist Bleeding Disorder Patients
By Ellen Riker

On Monday, March 30, CMS released an Interim Final Rule related to Medicare waivers and policy changes occurring during the current COVID-19 emergency. The rule includes significant changes to how and where hospital inpatient services may be provided, the provision of telehealth services by numerous providers and facilities, and changes to the Medicare Home Health Benefit. The Alliance Washington Team prepared a summary of the major provisions of the rule, which can be found here.

The Rule’s Home Health Benefit changes may help HTCs serve Medicare patients with bleeding disorders who are not able to self-administer their treatments. Historically, hemophilia and other bleeding disorders patients would not qualify for the Medicare home health benefit because they did not meet a stringent definition of homebound (literally not able to leave the home). Under the rule, CMS is redefining the definition of homebound during the COVID emergency. If the treating physician reports that it is medically contraindicated for the patient to leave the home, the patient will meet the homebound standard and qualify for home health benefits.

There are other requirements, which patients must meet to qualify for home health benefits, including that the patient must be under the care of a physician and have a plan of care established and periodically reviewed by a physician. In addition, the patient must be in need of skilled nursing care on an intermittent basis or physical therapy or speech-language pathology or a continuing need for occupational therapy.

HTCs should contact home health care agencies in their area. Under the home health benefit these agencies are able to contract with the HTC for bleeding disorders products and infusion services if they are not able to provide them directly. The home health agency should be able to tell you how to bill for treatments, but contact the Alliance for assistance if needed.

For more information please see the discussion in the Interim Final Rule on this topic here on pages 60-64 (with the most relevant information on pages 62-63). More information on the Medicare home health benefit can be found here.

Payer Update

Coronavirus Policy Changes and Medicaid
By George Oestreich

States and the federal government are pursuing a variety of policy changes to help Medicaid programs respond to the coronavirus emergency. Following the federal Declaration of Emergency, the Centers for Medicare and Medicaid (CMS) issued a blanket emergency waiver relaxing many polices governing Medicare and Medicaid. These changes would modify or suspend policies for the duration of the Emergency (or up to 60 days beyond in some cases). The blanket waiver areas generally waive:

  • Program provider participation regulations requiring extensive applications for inclusion into state Medicaid programs
  • Specific state provider licensure (as long as a valid license exists in another state) in order to provide and bill for Medicaid services to allow for rapid expansion of workforce
  • Prior authorizations for medical benefits (pharmacy separate and variable)
  • Restrictions on utilization of telehealth services to permit healthcare to be provided more efficiently and safely
  • Inspection and licensure of areas where tests and services may be performed
  • Limitation on roles allowing greater use of allied healthcare providers within their scope of practice (as long as those modifications do not impede a state’s emergency plans).

The states may use the terms and conditions of the blanket waivers to operationally allow their Medicaid agencies flexibility and efficiency within the blanket terms. States may also request 1135 waivers that reduce or suspend regulations in specific areas. There are examples provided on the CMS website. These subsequent waivers are generally approved very quickly, within 72 hours. States may submit more than one 1135 waiver request and may also submit state plan amendments (SPAs) either for temporary or permanent changes in Medicaid operational policy. At least 44 states have exercised this option.

The areas covered by the Section 1135 waivers most likely to impact hemophilia treatment centers are the following:

  • Access to the use of telehealth services allowing the providers greater and safer access to patients during the pandemic
  • Access to providers in contiguous states to support services needed if the traditional provider in-state is unavailable
  • Access to out-of-state pharmacy or out-of-network services to support limited medication availability

The increase in the federal matching Federal Medical Assistance Percentage (FMAP) is of great importance to states. Authorized in the CARES legislation passed last month, each state received an increase in FMAP of 6.2% over standard Medicaid levels. Children’s Health Insurance Plans (CHIPs) are also covered but at a higher rate. The FMAP dictates the amount of federal funds each state receives to reimburse for Medicaid services. The base match is a product of the state’s overall wealth. When the average income is low, the FMAP is high. FMAPs range from about 50% to 75%. The increase translates to $0.062 more in federal match for each $1 Medicaid dollar paid. A state that normally receives $0.50 in federal funds for each dollar spent now receives $0.562.

States have discretion over how to use these funds for delivered Medicaid services. No SPA is required to apportion the funds. The funds will be available by each quarter in which the Emergency Declaration is active. For example, if the declaration would end April 28th the enhanced match would be available through June 30, 2020. In some states, the Medicaid agency has worked with providers to submit 1135 waivers for increased reimbursement for increased expenses associated with the COVID-19 pandemic.

The relationship between the Medicaid programs and your HTC is very important. Maintaining contact with the Medicaid agency and understanding how their polices work will support the understanding of your programs, your problems and the success of your mission. Maintain and build on those relationships year in and year out, day in and day out. Let our Hemophilia Alliance Team know when and how we can help you with your third party and Medicaid issues. We are here for you. Stay safe.

Alliance Update

Social Work Planning Committee Member Needed
By Jeff Amond

The Hemophilia Alliance seeks to fill two vacancies on the Planning Committee for the Annual Linda Gammage Social Work Conference. Ideal candidates should be currently employed at a federally-supported HTC that is a member of the Hemophilia Alliance. This volunteer opportunity involves working collaboratively with other committee members to identify appropriate topics, recruit speakers and plan/evaluate programs. Committee members participate in conference calls and one in-person planning meeting per year, if needed. The role generally requires a commitment of about two hours per month. The term is three years. Interested individuals should submit their CV and a Letter of Interest to Jeff Amond at amond@hemoalliance.org by Friday May 8, 2020.
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2020 Meeting Schedule

  • Hill Day: More information to be announced
  • Fall Members Meeting: October 4th to 6th
  • New member meeting rescheduled November 2020

Notes from the Community

Hemophilia Alliance Foundation Provides COVID-19 Relief for Patient Assistance
By Grant Hiura

Some good news in this most difficult time! On March 31st, with the generous support of the Hemophilia Alliance, the Hemophilia Alliance Foundation announced the COVID-19 Relief for Patient Assistance Grant. In just the first week of accepting applications, we have already provided $123,000 to 25 local organizations to help support their patient assistance programs. If you have not yet applied, we encourage you to read the grant guidance and submit an online application here.

We are working to process your applications as quickly and efficiently as possible, and we wanted to address some common questions that have arisen so far:

  • We are currently prioritizing applications from NHF chapters and/or HFA member organizations that demonstrate a critical financial need. We may be able to expand these criteria based on community response and available funds
  • HTCs are not eligible to apply in this current process but are strongly encouraged to work with their local chapters/member organizations to identify areas of greatest need (please see below)
  • National organizations are not currently being considered at this time

How HTCs can help:

We realize that as the virus spreads, there is an exponential increase in need for financial assistance among families. Frequently, HTC social workers are the ones working directly with patients and their families to address their issues, many of which are financial. We are therefore asking for your help to identify these patients/families and to work closely with your local NHF chapters or associations and HFA member organizations to provide these families with the assistance they so greatly need. Examples include:

  • Living expenses
  • Food assistance
  • Transportation
  • Child or eldercare
  • Healthcare expenses

If you have any other questions, please reach out to Grant Hiura at grant.hiura@hemophiliaalliancefoundation.org. Thank you and stay safe!

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Update from Hemophilia Federation of America on its Helping Hands Program

The COVID-19 Relief program page is now live. As of 4/10/20, HFA has approved 18 applications for COVID-19 Relief totaling $12,270 in assistance, which includes 17 applications for housing and 1 for utilities. The page includes a description of program eligibility and application process and a link to our new COVID-19 referral form. We have been working hard to set up the infrastructure for this new program to make it easy to track and report on applications. The Helping Hands staff will train 5-7 of our colleagues to be temporary relief program coordinators to help call applicants and complete applications, as we expect an influx of referrals once the new portal is publicized.

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ASH ISTH NHF WFH Guidelines on the Diagnosis and Management of von Willebrand Disease Open for Comment

The ASH ISTH NHF WFH Guidelines on the Diagnosis and Management for von Willebrand Disease are now open for comment. Materials are available at https://tinyurl.com/uf8htqy. The deadline to comment is April 30, 2020.

The goal of this joint effort is to create and maintain state-of-the-art guidelines to improve diagnosis and management of VWD, and improving care and health outcomes important to patients and their caregivers. The sponsors seek people with von Willebrand disease and their family members, caregivers, and healthcare providers to participate in this important endeavor.

This comment period is open to all members of the public. Feedback received will be provided to the guideline panels for review. Comments will also be considered during organizational approval of the guidelines, peer review of the guidelines for journal publication, implementation and dissemination efforts following publication, and future revision efforts.

These Guidelines on the Diagnosis and Management of von Willebrand Disease were developed through a collaboration between the American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), the World Federation of Hemophilia (WFH), and the National Hemophilia Foundation (NHF). These guidelines followed a systematic process, led by the University of Kansas Medical Center, intended to meet recommendations of the Institute of Medicine (now the National Academy of Medicine). Recommendations were formed by guideline panels that include experts in VWD from multiple disciplines, methodologists, and patient representatives.

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Coronavirus (COVID-19) and Hemophilia Summer Camp Considerations
By Tracey Gaslin PhD, CPNP, FNP-BC, CRNI, RN-BC, Hemophilia Nurse Practitioner, Executive Director, Association of Camp Nursing

For many of us, summer camp is one of the highlights of our year. We recruit campers from our treatment centers (HTCs), organize activities, train staff, develop protocols, and plan for one of the most enlightening experiences for children living with bleeding disorders. This year, our challenge is we have been thrown a Coronavirus curveball. As I write this, COVID-19 is still a moving target. Most of us are tracking the changes daily with the hope of seeing the numbers of affected individuals start to fall very soon. The intent of this article is to provide guidance as you plan for summer in the face of this current pandemic.

At the present time, many camps have not made a decision about cancelling camp for the summer– especially if camp does not start until June or July. Therefore, we continue to plan and consider updates to procedures and practices for the health and safety of campers and staff. One of the first and most helpful actions is preparatory work. A proactive approach to camp can potentially alleviate many issues during the experience.

We encourage you to start communicating with families about the COVID-19 virus. Remind families how the condition is spread (primarily through droplet transmission) and the three most common symptoms (fever, cough, shortness of breath). Most individuals will be aware of this information; however your sharing helps families understand the camp’s level of understanding related to the condition. Families are putting their child in your hands and want to know that you have a good working knowledge about support and care. Consider the following updates or additions for camp operations:

  1. Encourage families to start educating the child at home before arriving at camp. There is a document titled “A Healthy Camp Starts at Home” and it is available and free. You can retrieve the document from campnurse.org. This document outlines items for families to discuss: handwashing, coughing in sleeve, adequate rest, hydration, physical distancing, and many other helpful items. This document is an easy way to start the educational process now. Load this document to your website or send out to potential families as they are inquiring about camp.
  2. Consider Health Screening practices: Health screening is an effort to encourage everyone to arrive to camp in a healthy state. If your camp currently does health screening, consider adding questions regarding fever, cough, shortness of breath, and recent travel. If your camp does not conduct health screening, now is the time to start. We encourage everyone to check a temperature on folks when they arrive (campers and staff). If you could benefit from viewing an example of a health screening form, you may find one at campnurse.org.
  3. Communicable Disease Plan: If your camp has a communicable disease plan (CDP), consider revisiting that plan and making sure the procedural steps are still up to date and appropriate. If you do not have a CDP, now is a great time to create one. A CDP organizes important steps for prevention of illness, intervention in the event there is an outbreak at camp, and recovery once an event has resolved. Consider using “Communicable Disease Practice Guidelines”. This tool is free (campnurse.org) and can guide you through the steps to create a CDP.
  4. Consider what products you will use for cleaning. Coronavirus is easily killed and most household cleaners will work.

    1. Center for Disease Control Cleaning Products (CDC): https://www.cdc.gov/coronavirus/2019-ncov/community/home/cleaning-disinfection.html?mod=article_inline
    2. Environmental Protection Agency (EPA):

Coronavirus, like many other viruses, is going to be around. We need to learn how to manage with good prevention practices and access to resources in time of need. Individuals most likely reading this are well-versed in hemophilia care. However, there is much to consider when operating a summer camp to keep individuals healthy. Consider visiting the American Camp Association (acacamps.org) and the Association of Camp Nursing (campnurse.org) as these organizations set the standards for health, wellness, and camp operations. They are eager to help and provide a wealth of information for your benefit. Engage in proactive efforts for camp and start taking those steps now. There is much to consider as we factor in considerations for COVID-19 as we strive for safe and healthy bleeding disorder camps across the country.

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
Jeff Amond amond@hemoalliance.org 608-206-3132
Karen Bowe karen@hemoalliance.org 717-571-0266
Johanna Gray, MPA jgray@artemispolicygroup.com 703-304-8111
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Elizabeth Karan ekaran@feldsmantucker.com 612-202-3240
Kimberly W. Lackman kimberly@hemoalliance.org 813-400-6710
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@artemispolicygroup.com 202-257-6670
Mark Plencner mark@hemoalliance.org 701-318-2910
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Theresa Parker theresa@hemoalliance.org 727-688-2568
Joel Bellucci webmaster@hemoalliance.org 727-504-0491