Legal Update, October 2022

Legal Update

How to Compliantly Increase Visibility of HTCs and the Comprehensive Care Model
by Elizabeth “Issie” Karan, Legal Counsel

Recently, several Hemophilia Treatment Centers (HTCs) have inquired about the rules and any limitations on marketing their programs. As described further below, these activities can be vital to HTC operations and have support in programmatic guidance.

The request for applications for Regional Hemophilia Networks from the Maternal Child Health Bureau (MCHB) includes language that suggests HTCs must engage in outreach efforts. More specifically, the Funding Opportunity Announcement from 2016 states that for patients with hemophilia and blood or clotting disorders that are seen within HTC subawardees in a region, grant program is intended to:

  • Increase family engagement
  • Increase patients with medical home
  • Increase transitions to adult health care
  • Increase number of patients with hemophilia and related blood or clotting disorders that have had an annual comprehensive care
    (Regional Hemophilia Network, HRSA-17-074, page 5)

Additionally, HTCs are instructed to “identify, prioritize, and address emerging issues of importance, including increasing access to, and the improvement of, hemophilia and related bleeding and clotting disorder services through outreach to underserved populations in conjunction with key stakeholders.” (HRSA-17-074, page 2) As this language highlights, HTCs must find ways to connect with patients in their areas, particularly those not currently being treated under the comprehensive care model.

The Uniform Grants Guidance (UGG) provides somewhat conflicting guidance on advertising. 45 CFR §75.467 states that costs associated with selling and marketing services, or goods is typically unallowable. However, 45 CFR §75.421 describes allowable expenditures on advertising and public relations to include program outreach and other specific purposes necessary to meet the requirements of the Federal award.

Given the emphasis on these activities in the Funding Opportunity Announcement from MCHB, HTCs likely can conclude that the government expects them to devote resources to connecting with the patient community. However, whenever in doubt, HTCs can check with their regional leadership or reach out to the Hemophilia Alliance for more guidance.

Also in this Issue…

Notes from Joe
· 340B Blues

Alliance Update
· Meet Jennifer Anders!
· Finding Talent Within the Bleeding Disorders Community!
· Update re: Re-Accreditation of Gene Therapy Modules Developed by Partners

Washington Update
· Webinar on Implementation of the Hemophilia Skilled Nursing Facility Access Act Available

Payer Update
· Payer Trends: What You Need to Know

Notes from the Community
· Illinois Ultra-Rare Bleeding Disorders Event a Success

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