LSHC Horizons Brochure 2024 - Flipbook - Page 26
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Cell, Tissue, and Gene Therapies
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Patient finding initiatives: Legal considerations
In the age of personalized medicine and
as treatments for rare diseases increase,
identifying potential patients and providing
targeted product education to those patients
and their treating health care professionals
(HCPs) has become increasingly important
to manufacturers. Beyond significant privacy
concerns, however, initiatives to find patients
and to engage with their HCPs may present
risk under the fraud and abuse and other laws,
and should be structured in light of available
industry guidance and emerging enforcement
trends. Three types of patient-finding initiatives
warrant particular consideration.
• Sponsored testing programs provide
manufacturer-sponsored testing for patients
to determine whether the patient has the
condition for or is an appropriate candidate
for an approved treatment. These programs
have recently come under scrutiny. In 2022,
the Office of Inspector General (OIG) for the
U.S. Department of Health & Human Services
(HHS) issued a favorable Advisory Opinion
22-06 (AO 22-06) on one such program,
and in December 2023, the Department
of Justice (DOJ) announced a $6 million
settlement related to a sponsored genetic
testing program, with particular focus on the
manufacturer’s receipt and use of test data
(including physician ordering information)
for marketing and promotional purposes. In
response, sponsored testing programs should
be structured to align with the safeguards and
principles enumerated in AO 22-06, wherever
possible, and manufacturers should consider
limiting their receipt and use of physician
ordering information and other testing data.
Eliza L. Andonova
Partner
Washington, D.C.
• Telehealth platforms: Manufacturers have
implemented or explored offering directto-consumer access by connecting patients
from the manufacturer product websites
to telehealth vendors for assessment and
potential prescription of the manufacturer’s
product. These programs, particularly for
certain lifestyle drugs, or when limited to
cash-pay, have grown in popularity since the
COVID-19 pandemic transformed patient
acceptance of telemedicine. However,
programs that bill insurance, and particularly
federal health care programs, raise risks
under the Anti-Kickback Statute (AKS), both
through the referral to the telehealth provider
and through potential payments to the
telehealth vendor that could be viewed induce
prescriptions for the manufacturer’s product,
and should be carefully structured.
• EMR tip sheets that offer guidance on how
to identify potential patients through the
electronic medical records (EMR) may be
particularly important for identifying patients
of rare diseases. Providing information about
how HCPs can query their EMRs consistent
with the product’s indication likely presents
low risks, but there are execution risks in
how the tip sheets are used, particularly if
personnel assist HCPs through accessing
patient protected health information or
overstep into the HCP’s sole responsibility
to determine whether a particular product is
appropriate for a specific patient.
Ronald L. Wisor, Jr.
Partner
Washington, D.C.
Laura Hunter
Senior Associate
Washington, D.C.
