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Keeping you afloat amidst the rising sea of regulations

OIG Report Highlights Impact of Improper Drug Classification

In late December 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released the findings of a report titled Potential Misclassifications Reported by Drug Manufacturers May Have Led to $1 Billion in Lost Medicaid Rebates, which was conducted in response to a request from Congress to “evaluate the accuracy of manufacturer-reported drug classification data in the Medicaid rebate program.” The OIG determined that while the “vast majority” of some 30,000 drugs reimburs

DOJ Reports $3.7 Billion in False Claims Act Recoveries in FY 2017

The Department of Justice recently published its annual False Claims Act (FCA) recoveries statistics for Fiscal Year 2017, reporting $3.7 billion in FCA settlements and judgments in FY 2017. That number brings DOJ’s total FCA recoveries since FY 1987 to more than $56 billion, and its total since 2009 to nearly $34.5 billion.

PhRMA Challenges Constitutionality of California’s New Drug Pricing Transparency Law

On December 8, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit in the US District Court for the Eastern District of California seeking to block California’s new drug transparency law. The complaint for Pharm. Research and Mfrs. of Am. v.

Rare Pediatric Disease Clinical Trials Get New Lift from EMA-Inspired Gaucher Model

On December 6, 2017, FDA announced a new approach for pediatric disease drug development that the Agency believes will reduce the number of patients treated with a placebo and lead to more time-efficient product development. According to FDA Center for Drug Evaluation Director Janet Woodcock, M.D.,

Medical Providers & Concepts of Authority Article

The world of health care reimbursement can involve many different players on the payer side. Group health plans and health insurers are well-known players, but networks, administrators, repricers, consultants, and others may enter the scene as well. Knowing which entities can be held liable for payment, and how, may be critical to a medical provider’s ability to secure the payment to which it is entitled. 

The Healthy Indiana Plan: A National Model for Medicaid Reform?

Arent Fox Health Care Partner David Greenberg and Associate Sean Clerget recently published an article in Bloomberg Law discussing health care reform, specifically focusing on the Medicaid program and how innovations currently in place in Indiana may serve as the model for Medicaid reform under the current administration.   

FDA Issues Comprehensive Tissue Product Regulatory Framework

On November 16, 2017, FDA announced a comprehensive regenerative medicine policy framework to provide additional clarity regarding existing and future tissue regulation. This framework includes a final guidance document establishing FDA’s interpretation of integral terms relating to regulation of certain tissue products, as well as draft guidances regarding the statutory designation of regenerative medicine advanced therapies (RMATs) authorized under the 21st Century Cures Act.   

Just in Time for the Holidays: California Agencies Propose Emergency Regulations for Temporary Cannabis Licenses

With less than 45 days until the January 1st implementation of Proposition 64 (the proposition that legalized cannabis in California) and the effective date for the Medicinal and Adult-Use Cannabis Regulation and Safety Act (an act that regulates cannabis), the California agencies given licensing authority under the law posted their proposed emergency regulations for commercial medicinal and adult-use cannabis.

HOPPS 2018 Final Rule Released, Confirming Changes to Medicare Part B Drug Reimbursement for Drugs Purchased Under the 340B Program

The advance copy of the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (HOPPS) final rule for calendar year 2018 (the Final Rule) was released on November 1, 2017. The official version of the Final Rule will be published in the Federal Register on November 13, 2017.

California Bans Inquiries Into Applicant’s Salary History, “Bans the Box” On Criminal History Inquiries

California Governor Jerry Brown signed two major pieces of legislation affecting the application and hiring process for nearly all employees. AB 168 prohibits employers from seeking salary history information about an applicant for employment, among its related provisions. AB 1008 “bans the box” on employers’ applications asking about criminal conviction history. Instead, employers will be able to inquire into, and consider, an applicant’s conviction history only after making a conditional offer of employment.