In July 2015, we posted about the N.Y. Attorney General’s False Claims Act (FCA) settlements with Trinity HomeCare and its related entities, and how the case provided insight into the future of FCA enforcement. We identified...more
4/17/2017
/ Attorney General ,
Business Associates ,
Enforcement Actions ,
False Claims Act (FCA) ,
HIPAA Privacy Rule ,
Kickbacks ,
Patient Privacy Rights ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Settlement
Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more
Government and private health-care program payers have been anxiously awaiting FDA action on biosimilars. Payers anticipate that the ability to substitute and dispense a biosimilar product in lieu of a more expensive...more
The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more
On Jan. 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
On Jan. 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
In what is believed to be the first legal challenge to the HIPAA Omnibus Rule (the “Rule”), a vendor of prescription drug adherence services is seeking an injunction to block certain provisions of the Rule related to drug...more
After receiving many comments on its Draft Call Letter, CMS published its Contract Year 2014 Final Call Letter on April 1, 2013. The Final Call Letter addresses a wide variety of issues that will affect all parties involved...more