Legal Update, April 2020

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.

Also in this Issue…

Notes from Joe
· Fighting Back

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 Schedulee

Notes from the Community
· Hemophilia Alliance Foundation Announces New “Large” Grant