Publications

Published Works

340B Program Restatements and Refunds: A whitepaper by Hogan Lovells and Deloitte Risk and Financial Advisory

It is a time of change in the 340B Program. Manufacturers should closely monitor 340B Program developments and prepare to respond promptly and effectively to changes in legal requirements....

Hogan Lovells Publications

Administration presents plans to lower drug prices

On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce...

Hogan Lovells Publications

MDRP: CMS issues new rebate agreement; all current agreements terminate October 1, 2018

On March 23, 2018, the Centers for Medicare and Medicaid Services (CMS) published Final Notice that implements a substantially revised Medicaid National Drug Rebate Agreement...

Hogan Lovells Publications

2019 White House and HHS budgets released: Key changes to drug pricing and reimbursement proposed

On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others,...

Publications

HRSA delays 340B CMP and Ceiling Price Rule to July 1, 2018 and intends to reopen rulemaking

Yesterday, the Health Resources and Services Administration (HRSA) issued a Final Rule delaying the effective date and the enforcement date of the 340B Drug Pricing Program Ceiling...

Hogan Lovells Publications

340B Program Ceiling Price and CMP Final Rule Delayed Until May 22

On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the 340B Ceiling Price and Civil Monetary...

Hogan Lovells Publications

340B Program: HRSA Releases Ceiling Price and CMP Final Rule

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on...

Hogan Lovells Publications

Are your reasonable assumptions ready for their close-up? The OIG's 2017 Work Plan and continuing focus on drug pricing and reimbursement

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) releases an annual Work Plan that details where it will focus its energies during the next year. The OIG...

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