The Health and Human Services Office of Inspector General (OIG) recently released a report on its review of the Open Payments program, titled “OPEN PAYMENTS DATA: REVIEW OF ACCURACY, PRECISION, AND CONSISTENCY IN REPORTING.” The OIG reviewed data from calendar year 2015 available as of June 2016. The OIG’s key takeaway […]
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.
The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]
***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 […]
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 […]
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 […]
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 […]