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

The recent influx of state legislation on biologics and biosimilars may actually hinder rather than advance the use of biosimilars. Our colleagues Theresa Carnegie, Joanne Hawana, and Ellyn Sternfield discuss this issue in a recent article published in BNA’s Medicare Report. The article examines recent state and federal action affecting substitution and reimbursement of biosimilars. In a previous blog post, we looked at the guidance released by the Centers for Medicare and Medicaid Services on reimbursement of biosimilars under Medicare Parts B and D and Medicaid.

Continue Reading State Action May Block Big Savings on Biosimilars

2015 promises to be a big year for biosimilars.  Our colleague, Thomas Wintner, recently published an article in Law360 highlighting the biosimilar developments to expect in 2015 and potential areas for future litigation.  As the article points out, though the Affordable Care Act created an abbreviated pathway for FDA approval of biosimilars in 2010, no applications for approval were submitted to FDA until 2014.   

In addition to issues related to how the FDA will review and approve biosimilars and how intellectual property questions will be litigated and resolved, the approvals of the first biosimilars raise questions about how states will treat biosimilars under their pharmacy laws and how payers will address biosimilar substitution.  States already regulate the substitution of generic small molecule drugs for their brand-name counterparts and many states have considered, or have already enacted, legislation addressing the substitution of biosimilars for their reference product counterparts.  According to the National Conference of State Legislatures, at least 23 states have considered legislation regarding standards for biosimilar substitution.  Some common features of these legislative efforts include permitting prescribers to prohibit substitution, requiring pharmacists to notify prescribers of a substitution, requiring patient consent for substitution, requiring states to create a list of interchangeable products, and requiring pharmacists and prescribers to maintain records of substitution.  To date, eight states have passed laws regarding biosimilar substitution (Delaware, Florida, Indiana, Massachusetts, North Dakota, Oregon, Utah, and Virginia).  Colorado and New Jersey currently have biosimilar substitution bills pending in their legislatures.