Health Care Counsel Blog

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.

South Carolina has become the first state to enact an insurance data security act based on the Insurance Data Security Model Law drafted by the National Association of Insurance Commissioners, which is based on New York’s Cybersecurity Regulations (23 N.Y.C.R.R. Part 500).

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.

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.

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.

Health plans and administrators subject to the Employee Retirement Income and Security Act have been warned: failure to comply with ERISA’s procedural requirements may strip them of the deference their benefit determinations enjoy.

The Centers for Medicare & Medicaid Services published a final notice in the Federal Register on March 23, 2018, to amend and update for the first time since its original release in 1991 the Medicaid National Drug Rebate Agreement.

the Centers for Medicare & Medicaid Services issued a National Coverage Determination on March 16, 2018 approving Medicare coverage and payment for diagnostic laboratory tests utilizing next generation sequencing, or NGS, for patients with certain types of advanced cancer.

Oregon is the latest state to adopt a drug pricing transparency law, following in the footsteps of Vermont, California, Nevada, and Maryland, which have all adopted pricing and/or transparency laws of some variety over the past year.

In a recent 8-6 en banc decision, Ariana M. v. Humana Health Plan of Texas, Inc., No. 16-20174, 2018 WL 1096980 (5th Cir. Mar. 1, 2018), the Fifth Circuit Court of Appeals overturned its precedent, to step in line with the majority of other circuits.

Starting in April 2018, the Centers for Medicare & Medicaid Services will begin to implement significant changes to the look and content of Medicare identification cards.

A recent settlement announced by the US Department of Justice serves as a warning to pharmaceutical and device manufacturers that the government remains concerned about the provision of expensive meals to physicians and the impact such meals may have on a physician’s independent medical judgment.

A long time coming and after much anticipation and speculation, CMS is about to unveil an electronic reporting system in which manufacturers will report to CMS their quarterly ASP calculations.