Articles and Blogs

In an important development for 340B participating providers (“Covered Entities”), the Department of Health and Human Services (“HHS”) Office of General Counsel (“OGC”) published an Advisory Opinion stating its view that drug manufacturers must honor 340B program discounts under contract pharmacy arrangements. The Advisory Opinion was remarkable in the clarity and forcefulness of HHS’s... READ MORE

On January 8, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an Informational Bulletin titled “Best Practices for Avoiding 340B Duplicate Discounts in Medicaid” (“Bulletin”). The Bulletin outlines best practices that CMS encourages state Medicaid agencies to consider to avoid the situation where a manufacturer provides both a Medicaid drug rebate and... READ MORE

On September 30, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published notice of a proposed survey (“Survey”) of drug acquisition costs for all hospitals participating in the 340B drug discount program (“340B Program”). The Survey would require reporting of acquisition cost data on 340B discounted drugs, referred to as specified covered outpatient... READ MORE

This week, CMS released the 2020 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center Payment System Proposed Rule (“Proposed Rule”). Among a host of other items, CMS announced its intent to continue paying Average Sales Price (“ASP”) minus 22.5 percent for most drugs acquired under the 340B drug discount program (“340B... READ MORE

Senate and House Appropriators Nail Down HHS Funding Bill On September 13, a conference committee of House and Senate appropriators finalized details of the fiscal year 2019 Health and Human Services (“HHS”) spending bill, H.R. 6157, which was combined with legislation to fund the Department of Defense. The conference agreement paves a path for... READ MORE

Medicaid Bills Advance in the House On September 7, the House Energy and Commerce Health Subcommittee advanced a series of health care-related bills that full Committee Chairman Greg Walden (R-OR) hopes to move to the floor before the end of September. Among the bills marked up by the subcommittee this week was the ACE Kids... READ MORE

More Changes Ahead for 340B The Human Resources and Services Administration (“HRSA”) released a final rule delaying the effective date of implementation and enforcement of the previously issued final rule implementing the 340B Drug Discount Program. The delayed rule, which was originally published on January 5, 2017, established the methodology for calculating the 340B... READ MORE