Policy & Medicine

AstraZeneca’s Inflation Reduction Act Lawsuit Rejected

Thomas Sullivan May 17, 2024 0

The United States District Court for the District of Delaware recently rejected AstraZeneca’s lawsuit challenging the authority granted to Medicare in the Inflation Reduction Act. AstraZeneca filed a lawsuit last summer, arguing that the pricing provisions in the Inflation Reduction Act violate due process protections by setting a “maximum fair…

Policy and Medicine Compliance Update – November 2023…

Thomas Sullivan Dec 1, 2023 0

Policy and Medicine Compliance Update October 2023 Issue…

Thomas Sullivan Oct 20, 2023 0

AstraZeneca’s Inflation Reduction Act Lawsuit Rejected

Stakeholders Urge DEA to Take Action to Extend Telemedicine…

Earlier this year, the Alliance for Connected Care, the American Telemedicine Association, ATA Action, the Consumer Technology Association, the Healthcare Information and Management Systems Society,…

HHS OIG Issues Favorable Opinion Regarding Patient Assistance…

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued Advisory Opinion No. 24-02, addressing a patient assistance arrangement by a nonprofit organization.…

Forging the Future of Healthcare: The US Consensus Framework for…

In an initiative to establish a more ethical, equitable, and collaborative healthcare system in the United States, leading healthcare stakeholders came together to create the US Consensus Framework…

Medicare Part D Greatly Increased Utilization Restriction on…

Health Affairs recently published a study that found Medicare Part D plans greatly increased utilization restrictions on prescription drugs from 2011 to 2020. The report found that Part D plans became…

FDA Issues Final Rule, Confirming IVDs are Devices Under the…

The United States Food and Drug Administration (FDA) recently published a final rule, making it explicit that in vitro diagnostic products (IVDs) are considered devices under the Federal Food, Drug,…

HHS ONC Issues Draft Federal Health IT Strategic Plan, Seeking…

The United States Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology recently released the 2024 – 2030 Federal Health IT Strategic Plan…

New York City Health Care Transparency Law Now in Effect

Earlier this year, New York Local Law 844-A took effect, directing New York City Mayor Eric Adams to establish an Office of Healthcare Accountability to increase health care price transparency in New…

Former Stimwave CEO Convicted on Two Counts of Health Care Fraud

Laura Perryman, the former CEO of Stimwave was recently convicted on two counts of health care fraud: one count of health care fraud and one count of conspiracy to commit health care fraud and wire…

JAMA Analysis Finds Open Payments Database to Be “Not Much More…

A research letter recently published in JAMA, the first longitudinal study of industry payments to United States physicians, recently analyzed the Open Payments platform. According to the research…

FDA Will Hold Listening Session on Future of Advisory Committees

The United States Food and Drug Administration (FDA) recently announced a planned listening session on June 13, 2024, as part of its process of optimizing advisory committees. The session will focus…

Sandoz Reaches $265 Million Price-Fixing Settlement

Sandoz and its subsidiary Fougera Pharmaceuticals recently announced a $265 million settlement with a class of direct drug purchasers – including CVS and Walgreens. The settlement stems from an…