Yesterday, the Department of Health and Human Services (“HHS”) through the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule that would require “direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition […]
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 […]
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.
***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 […]
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 […]
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 […]