Tag Archives: Prescription Drugs

Discounted Drugs under the 340B Program

Photo of Lee H. RosebushPhoto of Laura MacherelliPhoto of Marc WagnerBy Lee H. Rosebush, Laura Macherelli and Marc Wagner on Posted in Healthcare
The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B program prohibits pharmaceutical manufacturers from imposing restrictions on how their drugs are distributed. Read the full Alert.… Continue Reading

New Medicare Part B Payment Model is Most Recent Payor Response to Increasing Drug Prices

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
Recent activity by the federal government along with commercial payors may be indicative of further changes to how payors, providers, and pharmaceutical manufacturers engage in prescription drug arrangements. A recently announced proposed rule by CMS would create a new Medicare Part B prescription drug payment model intended to improve quality of care and deliver better value for … Continue Reading

CMS Pitches Controversial Payment Model for Medicare Part B Drugs

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
CMS recently announced a proposed rule that would potentially create a new Medicare Part B prescription drug payment model. The proposed model is intended to improve quality of care and deliver better value for Medicare Part B beneficiaries. However, many providers and drug manufacturers have expressed concern that the new payment model will emphasize cost-cutting measures at … Continue Reading

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s renewed interest in pediatric codeine use comes two years after the agency issued a black box warning, its … Continue Reading

FDA Proposes Electronic Distribution of Prescribing Information

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed rule that, if enacted, would require drug manufacturers to submit to the agency prescribing information to be posted on the FDA’s website, allowing the information to be … Continue Reading
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