Category: Pharmaceutical Pricing

OIG Provides Strong Rebuke of Pharmaceutical Free Drug Program

On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-14 regarding a proposed free drug program (“Proposed Arrangement”). Under the Proposed Arrangement, a pharmaceutical manufacturer (“Manufacturer”) will give free drug product (“Drug”) to hospitals for inpatient use to […]

HHS Releases Plan to Require Drug Makers to list prices on TV ads

Yesterday, the Department of Health and Human Services (“HHS”) through the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule that would require “direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition […]

Court Dismisses Lawsuit Challenging CA S.B. 17 But Gives Leave to Amend

This week a California judge dismissed a lawsuit filed in December 2017 by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CA S.B. 17. PhRMA had sought a declaration that Section 4 of S.B. 17 was unconstitutional and a permanent injunction preventing the state’s Governor and Director of the Office […]

CMS Releases Guidance Allowing Step Therapy for Part B Drugs

Today, the Centers for Medicare & Medicaid Services (CMS) released guidance and a Fact Sheet that will provide Medicare Advantage (MA) plans the option of utilizing “step therapy”  for Medicare Part B drugs.   Recall, the concept of changing the way Medicare pays for Part B drugs was first discussed in the Administration’s May 2018 Blueprint.

Connecticut and Vermont Latest States to Pass Drug Pricing Transparency Bills

Following on the heels of several other states, including California, Nevada and Oregon, that have enacted drug pricing transparency bills, Connecticut and Vermont are the latest states to join the fray. In Connecticut, Public Act No. 18-41 requires pharmacy benefits managers (PBM), health carriers, and drug manufacturers to report certain information […]

**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 […]