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340B program: CMP Final Rule effective and implementation date accelerated to January 1, 2019

USA - November 30 2018 Yesterday, the Health Resources and Services Administration (HRSA) issued a Final Rule (Final Rule) that accelerates the effective and implementation...

Ken Choe, Kathleen A. Peterson, Samantha D. Marshall, Alice Valder Curran, Christopher H. Schott.


Regulatory Insights for Life Sciences and Health Care Investments: Drug Pricing and Reimbursement

USA - November 29 2018 Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure...

Alice Valder Curran, Christopher H. Schott, Elizabeth (Beth) Halpern.


340B program: Proposed rule would accelerate the effective date of the CMP Final Rule from July 1, 2019, to January 1, 2019

USA - November 1 2018 Yesterday, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B...

Ken Choe, Kathleen A. Peterson, Samantha D. Marshall, Alice Valder Curran, Christopher H. Schott.


CMS considers linking Medicare drug payment rates to international prices

USA - October 30 2018 On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential...

Ken Choe, Ali Lakhani, Kathleen A. Peterson, Samantha D. Marshall, Beth L. Roberts, Alice Valder Curran, Christopher H. Schott, Elizabeth (Beth) Halpern, Stuart M. Langbein.


CMS Proposes Key Changes to the Medicare Advantage Program

USA - November 27 2017 On November 16, 2017, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would revise regulations and clarify...

Melissa K. Bianchi, Ken Choe, Jessica Robinson Hanna, Laura McDonald, Shereen R. Kanner, Helen R. Trilling, Craig Smith.