To Be or Not to 340B Blog

Legal Updates on the 340B Program

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To Be Or Not To 340B is a blog dedicated to the 340B Drug Pricing Program and its related laws and regulations. Our experienced health law attorneys are your eyes and ears for updates in the program and the law that affect covered entities, contract pharmacies and manufacturers.

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Topics

Audits
Certification/Recertification
Compliance
Contract Pharmacies
Covered Entities
Diversion
Duplicate Discounts
Guidance
Legislation
Manufacturers
Orphan Drugs

Federal Spending Bill Offers Re-Enrollment Path for Some Hospitals
The End of a Wild Year for 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback
Notice to Covered Entities: Manufacturer Seeking 340B Claims Data
CMS Publishes 340B Drug Acquisition Cost Survey: Respond by May 15, 2020
HRSA Unveils New 340B Flexibilities During COVID-19 Crisis

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