News & Analysis as of

Patients Regulatory Agenda

Manatt, Phelps & Phillips, LLP

North Carolina’s New Plan to Relieve Medical Debt

On July 1, North Carolina announced a new plan to relieve past medical debt for low- and middle-income consumers and mitigate the impact of medical debt going forward. Under the proposal, hospitals that choose to implement...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

Foley Hoag LLP on

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

Health Care Compliance Association (HCCA)

News Briefs: September 11, 2023

The HHS Office for Civil Rights (OCR) on Sept. 7 announced a proposed rule to bar discrimination based on disability.[1] “The rule, Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal...more

Foley Hoag LLP

United States v. Elizabeth Holmes and Ramesh Balwani

Foley Hoag LLP on

I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more

Dinsmore & Shohl LLP

Ohio Bill Would Ban Practice of Performing Intimate Exams On Anesthetized Patients Without Prior Consent

Dinsmore & Shohl LLP on

Ohio lawmakers are considering a bill – House Bill 89 – that would bar medical, nursing, and other medical-professional students from performing pelvic, prostate, or rectal exams on anesthetized or otherwise unconscious...more

Sheppard Mullin Richter & Hampton LLP

PBM Practices Receive Increased Federal Scrutiny

Though many recent reforms regarding prescription drug affordability have been focused on manufacturers and health plans, pharmacy benefit managers (“PBMs”) are also the focus of increased attention from federal policymakers...more

Hogan Lovells

EMA launches public consultation on the use of patient disease registries for regulator purposes

Hogan Lovells on

On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries...more

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