Life Sciences Horizons Brochure 2025 - Flipbook - Page 110
109
2025 Horizons Life Sciences and Health Care
New scrutiny for pharmaceutical market access innovations
Identifying patients for appropriate on-label use
of pharmaceutical products is critical from both a
business perspective and a public health perspective.
The rise of precision medicine and growth in rare
disease treatments have heightened the importance
of identifying appropriate patients for emerging
treatments through sponsored testing programs.
At the same time, telehealth platforms allow interested patients
to connect with virtual health care services, which has expanded
access to treatments but also introduced new risks and regulatory
considerations when manufacturers of available treatments
facilitate those connections.
Both types of market access innovations — sponsored testing
programs and telehealth arrangements — have recently attracted
governmental scrutiny in the U.S.
Sponsored testing programs generally involve pharmaceutical
manufacturers providing no-cost testing, typically for rare genetic
conditions, to potential patients. While these programs are
beneficial for patient diagnosis and education, they have been
scrutinized by regulators under the federal anti-kickback statute
(AKS). In two separate Advisory Opinions — 22-06 and 24-12 —
the U.S. Department of Health and Human Services Office of
Inspector General (OIG) emphasized the potential risks of these
programs, particularly when data is used for sales and marketing
purposes. In December 2023, Ultragenyx paid $6 million to resolve
allegations that their genetic testing program violated the AKS
because it involved the use of data for sales and marketing
purposes. And, in November 2024, QOL Medical paid $47 million
to resolve allegations that their testing program related to Sucraid
violated the AKS for similar reasons, plus the company allegedly
misled health care professionals about the efficacy of the
sponsored test.
Telehealth arrangements that link patients directly from
manufacturer websites to health care professionals have also
come under scrutiny due to concerns about potential kickbacks to
telehealth providers and the promotion of medically unnecessary
medications. These types of arrangements are often used by
manufacturers with products that treat lifestyle or common
maladies, such as obesity and migraines, but manufacturers in
other disease states have explored similar arrangements. The
continued growth of these arrangements has attracted attention,
and, in October 2024, Congress requested information from
Pfizer and Eli Lilly regarding their telehealth platforms and
relationships with prescribers, reflecting growing regulatory
interest in this topic.
Identification of appropriate patients for treatment with
medications leads to better health outcomes, reduces misuse of
medications, and improves adherence, but must also be done in
careful consideration of complex regulatory requirements and
emerging enforcement scrutiny.
Eliza Andonova
Partner
Washington, D.C.
Ronald Wisor
Partner
Washington, D.C.
Mike Dohmann
Senior Associate
Washington, D.C.
Laura Hunter
Senior Associate
Washington, D.C.
