On August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the first set of negotiated prices for the Medicare Drug Price Negotiation Program for 2026. Authorized under the Inflation Reduction Act of...more
On Friday, January 5, 2024, the US Food and Drug Administration (FDA) authorized the Section 804 Importation Program (SIP) proposal of Florida’s Agency for Health Care Administration (FAHCA). The SIP is a pathway that allows...more
In 2019, Congress and the Administration set out to make strides to effectuate policies to curb the rising costs of prescription drugs. These efforts while significant in number, were few in completion. Congress, while...more
Yesterday, 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...more
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...more
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...more
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...more
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...more
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...more
The President and Health and Human Services (HHS) Secretary Alex Azar unveiled a 44-page Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, designed to bring “soaring drug prices back down to earth.” The President...more
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...more
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...more
Last week, the White House declared the opioid crisis a “public health emergency.” The declaration outlined a number of steps the Administration will take to address the epidemic. The public health emergency declaration,...more
In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization. The bill, titled the “FDA Reauthorization Act of 2017,”...more
Recently, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions (HELP) Committee introduced a bipartisan discussion draft of legislation to reauthorize the Food and Drug Administration’s...more
On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model (Part B Demo). The Part B Demo had come under heavy fire from...more
Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act,...more
Last week, Vermont adopted the first state law that requires drug companies registering the highest hike in prices to justify the rationale for the increase. Vermont policymakers are not alone pursuing laws that address...more
In the wake of the uproar about drug pricing, Hillary Clinton unveiled on Tuesday, a plan to address the rising cost of prescription drugs. The plan will focus on ending “excessive” profits, lowering out-of-pocket costs,...more