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

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.

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.

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.

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.