News & Analysis as of

New Guidance Reporting Requirements Prescription Drugs

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Faegre Drinker Biddle & Reath LLP

Holiday Rush Brings Health Plans Eagerly Awaited RxDC Reporting Guidance and Relief

In FAQs Part 56, issued on December 23, 2022, the Treasury Department and the Departments of Labor and Health and Human Services (collectively, Departments) issued important guidance on prescription drug benefit and cost...more

Proskauer - Employee Benefits & Executive...

The Greatest Gift of All…Tri-Agencies Issue Welcome Relief on Prescription Drug Reporting

Just three short days before the December 27th deadline for health plans and issuers to report prescription drug and health care spending information to the government, on December 23, 2022, the Departments of Labor,...more

Smart & Biggar

New guidance documents and regulatory amendments regarding therapeutic product shortages

Smart & Biggar on

As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more

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