The June 13, 2018 Practical Law Practice Note co-written by Squire Patton Boggs attorneys Mark A. Salzberg, Elliot M. Smith, and John E. Wyand titled “State Legalized Marijuana Businesses and Access to the Bankruptcy Code” was recently updated to reflect recent case law as well as changes to the Controlled Substances Act. The Practice Note discusses the federal statutory scheme governing marijuana, its tension with state laws governing marijuana businesses, and the ability…

On Friday, November 30, 2018, the US Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (Proposed Rule) to revise Medicare Part D (Part D) and Medicare Advantage (MA) regulations to promote health plan negotiation of lower drug prices and to reduce out-of-pocket spending for enrollees. The Proposed Rule contains four areas of reform focusing on: (1) Plan Flexibility for Coverage of Protected Class Drugs; (2) Real-Time Coverage and Cost Information for Prescribers;…

On December 27, 2018, the provider community scored a major victory when the U.S. District Court for the District of Columbia held that the Medicare statute did not authorize the Department of Health and Human Services (“HHS”) to impose a nearly 30% reduction in 340B Reimbursement rates. The legal implications of this decision may be far reaching as the court held for the first time that HHS “acted outside of [its] authority to make adjustments…

In tandem with President Trump’s signing of H.R. 6, (now former) US Attorney General Jeff Sessions announced new Department of Justice (DOJ) funding awards aimed at curbing drug trafficking and supporting youth impacted by America’s opioid epidemic. At DOJ’s first-ever National Opioid Summit, Sessions and Deputy Attorney General Rod Rosenstein highlighted sustained federal law enforcement efforts to combat opioid abuse and related substance issues. DOJ’s nearly US$70 million investment, which closely follows the recent announcement…

On Wednesday, October 24, President Trump signed the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6) into law. The bill signing occurred three weeks following Congress’ overwhelming approval of the measure, and nearly one year since the Trump Administration deemed America’s opioid crisis a federal public health emergency. House Energy and Commerce Committee Chairman Greg Walden (R-OR) and Senate Health, Education, Labor, and…

Nearly three months following House passage of a legislative proposal related to America’s opioid epidemic, the Senate overwhelmingly cleared its own comprehensive, bipartisan package to address the crisis. On Monday, September 17, senators replaced the House-passed text with a substitute amendment and approved The Opioid Crisis Response Act of 2018 (H.R. 6) by a vote of 99-1. The bill, authored by Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN), resulted from…

FCC COMMENCES INQUIRY ON ESTABLISHING $100M TELEHEALTH PILOT PROGRAM On August 2, 2018, The Federal Communications Commission has unanimously approved a Notice of Inquiry (“NOI”) to establish a $100-million  telehealth pilot program. FCC seeks to identify how the agency can “help advance and support the movement in telehealth towards connected care everywhere and improve access to the life-saving broadband-enabled telehealth services it makes possible.” The NOI seeks public comment: initial comments by September 10 and…