Health Care Counsel Blog

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.

Legislation included as part of the massive congressional budget deal reached earlier this month will pave the way for expanded use of telehealth technologies that improve access to care and reduce cost of health care.

The Bipartisan Budget Act of 2018 was signed into law on February 9, 2018 in order to avert another shut-down of the federal government.

Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.

On December 28, 2017, the Centers for Medicare and Medicaid Services (CMS) issued Survey and Certification Memorandum Number 18-10-ALL to the State Survey Agencies clarifying its position regarding texting health care information by providers.

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies.

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.”