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Drug Pricing Reporting Requirements Rebates

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

Husch Blackwell LLP on

On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Goodwin

340B Rebate Pilot Program Proposed by HRSA

Goodwin on

On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more

Dinsmore & Shohl LLP

HRSA Announces Pilot Program for 340B Rebate Models

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On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the...more

Smart & Biggar

Slam dunk! New basket of countries for PMPRB reporting remain, controversial amendments to Patented Medicines Regulations dropped

Smart & Biggar on

On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more

Smart & Biggar

Confidential rebate reporting and new price regulatory factors of the amended Patented Medicines Regulations declared invalid by...

Smart & Biggar on

On February 18, 2022, the Court of Appeal of Quebec released its decision in Merck Canada Inc c Procureur général du Canada (2022 QCCA 240). This is the appeal of the Quebec Superior Court decision declaring price and revenue...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Making a List, Checking It Twice: Year-End Guidance on Drug Cost Reporting

Employers and their benefit administrators have more detail and a more convenient way to submit “top 50” lists and other data - but no more time to comply with - daunting prescription drug cost reporting requirements in the...more

Smart & Biggar

Quebec Court finds price and revenue calculation provisions of amended PMPRB Regulations unconstitutional

Smart & Biggar on

Update: The decision has been appealed. On December 18, 2020, the Quebec Superior Court issued its decision from a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act...more

Smart & Biggar

Countdown to July 1, 2020: Getting Ready for the New Patented Medicines Pricing Regime

Smart & Biggar on

On August 21st, the long-awaited amendments to the Patented Medicines Regulations were published in Part II of the Canada Gazette. We have prepared an unofficial consolidated version of the Regulations incorporating the...more

Smart & Biggar

Canada releases final amendments to Patented Medicines Pricing Regulations; in force July 1, 2020

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On August 9, 2019, Health Canada announced the final amendments to the Patented Medicines Regulations (see news release here and RIAS here). These amendments represent the first substantive revision to the Regulations since...more

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