All posts by Vince Sampson

Administration releases drug importation plan but implementation questions abound

Today, the Department of Health and Human Services (HHS) announced two “pathways” for drug importation. This plan is the latest step in the Administration’s push to lower prescription drug prices and one the President has strongly supported.   However, implementation of this plan has a long time horizon and a very […]

White House Withdraws Rebate Rule

Earlier this morning, the White House announced that they were scrapping a proposed rule (the rebate rule) that, among other items, would have [would eliminate the current safe harbor protection under the Anti-Kickback Statute for pharmaceutical manufacturer rebates to Medicare Part D plans, Medicaid MCOs and the PBMs with which […]

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 […]

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 […]

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

***Further update – Federal Court Vacates Rule*** Yesterday, U.S. District Court for the D.C. Circuit Judge Amit Mehta invalidated the final rule.  In ruling on the merits, Judge Mehta said the Department of Health and Human Services went beyond its rulemaking authority.   Specifically the ruling states, “[n]either the Act’s text, structure, […]

HHS Announces Innovation and Investment Summit

Yesterday, Department of Health and Human Services Deputy Secretary Eric Hargan announced the launch of the Deputy Secretary’s Innovation and Investment Summit (DSIIS).  DSIIS follows a June 2018 request for information to “develop a workgroup to facilitate constructive, high-level dialogue between HHS leadership and those focused on innovating and investing […]