Perspectives on Health Care

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court.

As was widely reported, Congress approved legislation late Monday, January 22, 2018 to provide continuing appropriations for federal agencies through February 8, 2018, ending the government shutdown that began Saturday.

A new administrative rule promulgated and adopted by the Attorney General for the state of New Jersey (the AG) will “regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers.”

This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.

The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule soliciting recommendations for new Anti-Kickback Statute (AKS) safe harbors, modifications to existing safe harbors, and new OIG Special Fraud Alerts.

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.”

Bloomberg BNA’s Health Law Reporter provided an in-depth overview of the issues that likely will test health care lawyers in 2018 based on commentary from Bloomberg Law’s Health Care Advisory Board of which health care partner Lowell Brown is a member.

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.

Arent Fox LLP is pleased to announce the election of 10 new partners and two new counsel, effective January 1, 2018.

The Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit against the state of California in response to the state’s new drug price 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 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.

Arent Fox Health Care Partner David Greenberg 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.

California agencies posted their proposed emergency regulations for commercial medicinal and adult-use cannabis.

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”

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.

Twenty-two Arent Fox LLP practices have been recognized in the 2018 “Best Law Firms” rankings that are published annually by U.S. News & World Report and Best Lawyers.

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.

Following in the steps of Maryland and Nevada, California just adopted a comprehensive drug pricing transparency law that will have a significant impact on the pharmaceutical industry, particularly on drug manufacturers. n

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.

Health care providers increasingly seek advice from attorneys on navigating the distinct forms of self-disclosure to government agencies for regulatory missteps.

Legislation is moving forward that could potentially ease the penalties associated with alleged violations of the physician self-referral (Stark) law.

The issue of where a medical provider with an assignment of benefits may sue an ERISA-governed healthcare plan for unreimbursed medical care is important.

On August 21, 2017, the Health Resources and Services Administration published a proposed rule that would entertain even further delays of the implementation of a January 5, 2017 Final Rule regarding calculation of 340B ceiling prices.

Arent Fox partner and national leader of the Health Care group Lowell Brown was quoted in the Modern Healthcare article, “C-suite pay raises target transformational healthcare leaders,” on executive compensation among health systems.