2021 LS&HC Horizons - Flipbook - Page 14
14
Hogan Lovells
A new normal: Manufacturer considerations for post-pandemic HCP
interactions
As pharmaceutical and medical device
manufacturers look forward to a post-pandemic
world, they face new compliance questions
about what interactions with health care
professionals (HCPs) and patients will
look like.
The pandemic forced manufacturers to pivot
to virtual HCP interactions, including speaker
programs. But a rare Special Fraud Alert issued
by the Department of Health and Human
Services Office of Inspector General (OIG)
in late 2020 has created uncertainty about
whether the in-person speaker programs the
industry has relied on to educate HCPs about
emerging treatments and products will return
in same form post-pandemic.
In the Special Fraud Alert, OIG flatly stated
that it is “skeptical about the educational value
of such programs” and that companies should
“consider alternative less-risky means for
conveying information” to HCPs. While noting
“certain inherent risks” of speaker programs –
since they involve remuneration for speakers
(compensation) and attendees (meals) – OIG
also identified factors that would render a
speaker program suspect. Although generally
reflective of industry best practices, these
factors include new or more explicitly stated
restrictions, including programs where alcohol
is available (especially if free) and programs
held at restaurants, without allowances
for modest restaurants or with separate
rooms appropriate for business meetings.
Manufacturers looking to resume in-person
speaker programs will need to reexamine the
structure and controls of their programs to
protect against the suspect characteristics
identified by OIG.
The pandemic also fundamentally transformed
the landscape of manufacturer-patient
interactions. Pandemic-related constraints
have accelerated the acceptance of telemedicine
by patients, HCPs, and payers. In response,
manufacturers need to establish parameters
for their interactions and engagements
with telehealth vendors and providers
while continuing to facilitate patient access
to their products. Relationships between
manufacturers and telehealth vendors, if not
properly structured, may pose risks under
federal fraud and abuse laws. The increased
prominence of telemedicine is likely to be
a permanent fixture in our post-pandemic
reality, and manufacturers will need to carefully
evaluate any proposed arrangements with
telehealth vendors.
Eliza Andonova
Partner, Washington, D.C.
eliza.andonova@hoganlovells.com
Ron Wisor
Partner, Washington, D.C.
ron.wisor@hoganlovells.com
Laura Hunter
Senior Associate, Washington, D.C.
laura.hunter@hoganlovells.com
