Insights on Health Care

On June 28, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) dropped their lawsuit challenging the constitutionality of Nevada’s recent drug price transparency law.

In-house counsel for health industry organizations face unique challenges – but those challenges can be met.

The Fifth Circuit recently held that plaintiffs seeking benefits, under plans governed by the Employee Retirement Income Security Act of 1974 and non-ERISA plans, need not identify and include specific plan provisions in their complaints to survive motions to dismiss.

On June 20, 2018, the Centers for Medicare & Medicaid Services issued a Request for Information seeking input from the public on how to address the undue regulatory impact and burden imposed on health care providers under the Stark Law.

Geoffrey Starks testified on Wednesday, June 20, 2018 before the Senate Committee on Commerce, Science, and Transportation.

The US Department of Justice remained busy in its first year of the Trump Administration, charging 20 individuals with violations under the US Foreign Corrupt Practices Act — the second highest year of individual prosecutions since 1977.

Edwin Simcox, Acting Chief Technology Officer for the US Department of Health and Human Services (HHS), lauded telehealth as an innovation that potentially offers ways to address HHS’s four key priorities.

The Department of Health and Human Services OIG has issued an advisory opinion approving an arrangement involving the provision of free telemedicine equipment and services by a provider to a potential referral source.

The California Office of Statewide Health Planning and Development (OSHPD) has posted a preliminary working draft of the regulations implementing California’s prescription drug price transparency law.

Connecticut and Maine recently joined the increasing number of states to enact drug price transparency laws. Maine’s drug price transparency law (the Maine Law) became effective on May 1, 2018.

The Centers for Medicare and Medicaid (CMS) is overhauling the Electronic Health Records (EHR) Medicare and Medicaid program for hospitals.

The 2018 edition of Legal 500 US has rated 50 Arent Fox LLP attorneys as national leaders in their field. In addition, 18 of the firm’s practice areas were ranked among the best in the country, including new recognition for the firm’s Trademark Litigation and White Collar groups.

On May 17, 2018, CMS issued a strongly-worded letter to Part D plan sponsors stating that pharmacy “gag clauses” are unacceptable.

In a recent decision, the US Court of Appeals for the Ninth Circuit held that a surgical center lacked standing to bring ERISA claims against a health plan because the plan had a valid anti-assignment provision.

Following delays and much build up, the White House and the Department of Health and Human Services (HHS) have released their plan to address rising pharmaceutical prices and out-of-pocket costs directly impacting patients.

On March 28, 2018, the Governor of Alabama, Kay Ivey, signed SB 318, the Alabama Data Breach Notification Act, which becomes effective June 1, 2018. Alabama is just behind South Dakota, which enacted its data breach notification statute this past March.

HRSA published a notice in the Federal Register on May 7, 2018 proposing its intention to delay – for the fifth time – the implementation of a January 5, 2017 Final Rule regarding calculation of 340B ceiling prices and the imposition of civil monetary penalties.

Chambers USA: America’s Leading Lawyers for Business has recognized 30 Arent Fox LLP attorneys as leaders in their field.

A development out of the Ninth Circuit makes relators more likely to qualify as an original source under the False Claims Act and thus survive the public disclosure bar.

The latest False Claims Act settlements indicate that the Anti-Kickback Statute continues to be an enforcement priority and a key tool for identifying and prosecuting healthcare fraud.

Arent Fox is pleased to announce the launch of a new Blockchain group that pulls together attorneys from a number of the firm’s top practices to help clients navigate this emerging technology.

Pharmaceutical manufacturers whose drugs are reimbursed under Medicare Part B must now report certain product and financial data (including Average Sales Price, or ASP) to the Centers for Medicare & Medicaid Services through the Fee-for-Service Data Collection System.

On April 13, 2018, the US Court of Appeals for the Fourth Circuit found Maryland’s new drug price-gouging prohibition law unconstitutional under the dormant Commerce Clause of the United States Constitution.

In a new final rule released on April 9, 2018, CMS is allowing states substantially more flexibility in selecting Essential Health Benefits (EHB)-benchmark plans for the 2020 plan year.

On March 21, 2018, South Dakota became the forty-ninth state to enact a data breach notification statute, which becomes effective July 1, 2018.