Category: 340B

HHS Proposed Rule Would Remove Safe Harbor Protection for Certain Discounts

On January 31, 2019, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule designed to combat rising drug costs (“Proposed Rule”). The Proposed Rule seeks to eliminate rebates paid by pharmaceutical manufacturers to plan sponsors or their pharmacy benefit managers (“PBMs”) […]

340B Drug Program Price Ceiling and Penalties Moved Up To Start January 1st

On November 30, 2018, the Department of Health and Human Services (HHS) issued a final rule that puts in effect January 1, 2019, rather than July 1, 2019 as previously announced significant changes to the 340B program including a ceiling price on how much drug manufactures can charge hospitals who […]

**UPDATED*** Administration Releases Long-Awaited Drug Pricing Reform Plan

***5/14/2018 Update***   This morning, HHS Secretary Azar gave a speech offering additional details on the Blueprint.  Included in his remarks are plans to publicly identify companies suspected of “using public health rules to pad their profits”; send letters to all Medicare Part D plan sponsors indicating gag clauses in pharmacy contracts are unacceptable […]

President set to outline drug pricing plan: how far will it go?

Tomorrow at 2 p.m., EST,  the President is scheduled to deliver a long-awaited drug pricing strategy speech to put “America’s patients first.”  While details of the speech have been closely held, it is anticipated that it will  discuss a “comprehensive strategy” for combating the rising cost of prescription drugs and build on two previous actions which […]

Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals directed at lowering the cost of prescription drugs. These proposals are presented across the Budget volumes that reflect the Administration’s policy and fiscal priorities. Since many of these proposals require  Congressional […]

Washington’s 2016 healthcare agenda remains unfinished, leaving plenty for 2017

As Washington speeds towards Election Day on November 8th, it is a good time to examine the status of the key legislative and policy issues impacting the healthcare and life sciences sectors.  Congress has few legislative working days remaining in 2016, but could make some headway on legislation to promote innovation as […]

Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights

We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register on February 1.  If you are still reading, despite the fact that we included “Technical Highlights” in today’s title, we […]