All posts by Vince Sampson

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.

**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 […]

FDA Releases Digital Health Guidance to Spur Innovation

On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the regulatory requirements for digital health technologies.  By clarifying what is – and what is not – subject to regulation, this set of guidance could create significant opportunities for […]

White House Declares Opioid “Public Health Emergency” However, Many Questions Remain

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, while acknowledging the scope and tragic costs of opioid abuse, falls short of a “national emergency” declaration […]

With Congress stuck, Administration starts process of unwinding ACA – Updated

Last week, the Administration took two actions aimed at rattling the foundations of the Affordable Care Act (ACA).  The President signed an Executive Order (EO) directing federal agencies to relax restrictions on insurance plans that do not have to comply with certain ACA rules.  The Administration followed that with an announcement […]