Category: Pharmaceutical Pricing

No Surprise! – Drug Pricing Legislation Picking up Steam

Legislation that addresses the cost of prescription drugs is inching closer to moving out of Congress. On Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the bipartisan Lower Health Care Costs Act (LHCCA) discussion draft. Today, the Committee released a new draft based on […]

Medicare for All unveiled in House. Some things old, some things new, but much left to do

Recently, progressive democrats in the House of Representatives lead by Rep. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI) released the long-awaited Medicare for All Act of 2019 (M4A) proposal.  M4A differs from single-payer plans released by Senator Bernie Sanders (I-VT) and various Washington think tanks. One of the most significant differences […]

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”) […]

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 […]

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

***Update- Final rule released*** Yesterday HHS released the final rule which takes effect in 60 days.  The final rule made some technical changes and one notable change, that state law-based claims that depend “in whole or in part on any pricing statement required by this rule” are preempted.  Yesterday, the Department […]

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.