Welcome to 340B @ Dentons, a newsletter designed to provide you with regular updates on the 340B Drug Pricing Program, including developments relating to compliance and oversight, regulatory and legislative initiatives, relevant Medicaid and Medicare coverage, billing, and reimbursement requirements, contract pharmacy arrangements, and more.

Our team —  Susan Banks, Christopher Janney, and Charles Luband — regularly advise hospitals, health systems, and other providers that participate in the 340B Program and publish the 340B @ Dentons newsletter to help you navigate the ever-evolving 340B landscape.

What can you expect from 340B @ Dentons

• Alerts regarding breaking developments in the 340B space
• In-depth analyses of proposed legislation, regulations, and subregulatory guidance that may impact 340B stakeholders
• Hot topics and insights into key issues in the complex and challenging world of 340B compliance

To sign up for 340B @ Dentons please click here.

Showing 1 - 7 of Total Results (7)

Recently passed drug misclassification legislation could impact 340B program stakeholders

April 10, 2019

The legislation, which passed the House of Representatives on March 25 and is now headed to the President’s desk, provides the Centers for Medicare & Medicaid Services (CMS) with an array of enforcement tools to tackle misclassification. The legislation will impact not only the Medicaid Drug Rebate Program, but likely the 340B Drug Pricing Program as well.

Trump administration FY 2020 budget request includes proposed changes to 340B

March 27, 2019

Every year, the President submits a budget request to Congress for the next fiscal year. On March 11, President Trump released his budget request for FY 2020, which includes several proposals that would significantly impact the 340B drug pricing program and participating providers.

340B stakeholders await release of International Pricing Index Model proposed rule

March 12, 2019

The Centers for Medicare & Medicaid Services (CMS) last October issued an advance notice of proposed rulemaking (ANPRM) to solicit public comments regarding how Medicare Part B pays for drugs and biologicals.

New California drug pricing initiative could significantly impact 340B providers

February 26, 2019

California Governor Gavin Newsom recently issued an executive order directing state agencies to consolidate their purchasing of drugs in an effort to increase the state’s bargaining power and lower its drug spend.

Update on HRSA’s forthcoming 340B ceiling price database

February 7, 2019

HRSA has developed a system and process for receiving and verifying drug pricing data from manufacturers before making 340B ceiling prices available to covered entities.

New 340B ceiling price and manufacturer CMP rule finally in effect: Implications for providers

January 22, 2019

After five delays and a lawsuit by hospital groups, the US Department of Health and Human Services (HHS) late last fall announced that the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, published back in January 2017, would become effective January 1, 2019.

Federal Court concludes HHS exceeded authority with Medicare Part B payment cuts for 340B drugs, but holds off on specifying remedy

January 3, 2019

On December 27, 2018, the US District Court for the District of Columbia concluded in The American Hospital Association, et al v. Alex M. Azar II that the US Department of Health and Human Services overstepped its statutory authority when it substantially reduced Medicare Part B reimbursement beginning in 2018 for drugs purchased through the 340B Drug Pricing Program.