The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid Services (CMS) seeks to address Part D drug prices. CMS proposes making certain changes that might lower drug costs (for Plan Sponsors and beneficiaries) and requests information regarding avenues to potentially lower Medicare beneficiaries’ point-of-sale drug costs. The three provisions in the Proposed Rule that most directly relate to drug pricing address: (1) generic drug formulary placement, (2) cost-sharing for follow-on biological products, and (3) whether and how to reduce point-of-sale drug prices based on manufacturer rebates and pharmacy price concessions that a Plan Sponsor might receive months after the beneficiary receives the drugs. We will concentrate on the first two provision in this post. The third provision, which is a request for information, will be discussed in a later post.  Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes Aim at Drug Prices

Last Friday, the HHS Office of the Inspector General issued a highly anticipated proposed rule that provides new and modified regulatory safe harbors to the Anti-Kickback Statute, amends regulatory provisions related to enforcement of the Beneficiary Inducement Civil Monetary Penalty Law (CMP) provisions, and attempts to narrow the prohibitions covered by the Gainsharing CMP.   The proposed rule affects a wide range of increasingly common health care business arrangements, including referral services, cost-sharing waivers (including under Medicare Part D), free transportation services, coupons, rebates, and retailer reward programs.

A Health Care Alert authored by my colleagues Theresa Carnegie, Thomas Crane, Carrie Roll, and Stephanie Willis provides an in-depth summary and analysis of the OIG’s proposals and notes areas ripe for stakeholder input.  Comments to the Proposed Rule are due December 2, 2014.