Estimating the Prevalence of Controversial Denials of Essential Medicines and Health Services Through Legal Case Review

Speaker(s)

Kelty E1, Varnum M2, Xie R3, Rubin P4, Sherman M5, Shiva N2, Cidlevich K6
1RA Capital, Old Saybrook, CT, USA, 2RA Capital, Boston, MA, USA, 3RA Capital Management, Newton, MA, USA, 4No Patient Left Behind, Washington DC, DC, USA, 5Harvard Pilgrim HealthCare, Boston, MA, USA, 6Goodwin, Boston, MA, USA

Presentation Documents

OBJECTIVES: There have been increasing cases of controversial denials of access to essential medicines and services to insured patients in need of care, but real-world prevalence is not understood. This study aims to estimate the prevalence using legal case review in the US.

METHODS: We conducted a targeted search of two legal case databases, Courtlink and Bloomberg, to identify relevant US lawsuits filed between 1/1/2022 to 3/25/2024 using keywords including “Deny” or “Denial”, “Health” or “Medical” and “Claim”. Cases were excluded if keywords included “Drug Rehabilitation”, “Drug Treatment Center”,“Substance Abuse”, “Substance”, “Mental Health”, “Hospice”, “Disability”, or “Life Insurance”.

We then reviewed the summaries of the initial set of cases to determine their relevance. For relevant cases, we further reviewed all available complaints and dockets to determine whether they represent controversial denials. For our final list, we extracted key characteristics (e.g., type of medical care) and summarized them descriptively.

RESULTS: The initial search returned 466 cases, among which 91 were deemed relevant from abstract review. The full-text review yielded 22 relevant cases. The most common denial categories were for Services / Surgeries at 64% (14), followed by Equipment / Devices 14% (3) Other 14% (3), medicines / drugs 9% (2). Neither of the two medicine denials was for newly launched products.

CONCLUSIONS: Despite increasing public concern of denials of essential medicines and services for insured individuals in the US, legal case review showed that it is uncommon that these denials are resolved in a court setting. This may be partially due to the fact that patients denied essential medicines become eligible for patient assistant programs by pharmaceutical companies. The study also demonstrated the feasibility of using legal case databases for health-related studies.

Code

EPH194

Topic

Health Policy & Regulatory

Topic Subcategory

Insurance Systems & National Health Care, Reimbursement & Access Policy

Disease

Biologics & Biosimilars, Drugs, Medical Devices, Surgery