In 2018, the U.S. Department of Health and Human Services (“HHS”) launched the “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Several HHS agencies requested comments and information from the public and have published new or proposed...
As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug discount and rebate arrangements that are commonplace between pharmaceutical manufacturers and Medicare Part D Plans and Medicaid Managed Care Organizations (and...
The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical manufacturers pay to Medicare and Medicaid plan sponsors and their pharmacy benefit managers (“PBMs”). The OIG proposed replacing the current safe harbor...
The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has identified the anti-kickback statute (AKS) and beneficiary inducements civil monetary penalty (CMP) as potential barriers to arrangements that could promote better patient care coordination and value-based arrangements. On August 27, 2018, the OIG published a Request for Information (RFI) seeking input...
All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made statements signaling that the agencies are focused on reducing prescription drug prices. In remarks at the Food and...
Alissa SmithAlissa represents health systems, hospitals, pharmacies, long-term care providers, home he...
Hannah McCallumHannah brings specialized knowledge and real-life experience to help her clients make infor...
Andrew BrantinghamAndrew's experience spans a wide range of industries, and has particular depth in...
Rebecca BrommelBecki assists clients in the areas of litigation and administrative law wit...
Katie CownieKatie has worked on business and corporate issues for more than 20 years. Many of...
Lillie CoxLillie assists a wide array of healthcare industry clients with corporate transact...
Ross C. D'EmanueleRoss works in the health care provider, payor, and drug and medical device segment...
Nathan EbnetNate represents clients in all stages of complex civil disputes, from pre-...
Elise FesterElise counsels a wide variety of clients in the Health Care industry on regulatory...
Adam FreedAdam provides strategic advice to health care providers through all stage...
Randall HansonRandall is an associate in Dorsey’s health transactions and regulations practice group.
Alan IversonAlan is a litigator in Dorsey’s trial group with a focus on clients in...
Michael JenkinsMike serves clients in highly regulated industries, including health care and gam...
Jamie McCartyJamie counsels clients in the healthcare industry in connection with complex busi...
Neal N. PetersonNeal regularly advises clients regarding compliance with laws specific to the he...
Mara SandersMara regularly advises clients on matters of state and federal regulatory complia...
Vanessa J. SzalapskiVanessa's practice focuses on litigation in the healthcare industry, including gen...
Claire H. ToppClaire works in three diverse sectors – health care, tax exempt organizations,...