Insights on Health Care

Arent Fox Health Care Partner Linda Baumann discussed the potential compliance risks facing hospitals in connection with recalled medical devices  for Bloomberg Law in an article titled, “Gaps in Hospital Recalled Device Reporting a ‘Wake-Up Call.’”

Arent Fox Health Care Partner Linda Baumann discussed the potential compliance risks facing hospitals in connection with recalled medical devices for Bloomberg Law.

The Centers for Medicare & Medicaid Services (CMS) 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 (NDRA).

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.

Attorney General Jeff Sessions announced the launch of the Prescription Interdiction & Litigation Task Force, which will use criminal and civil law enforcement tools to combat the nation’s opioid epidemic, specifically targeting drug manufacturers and distributors.

Please join Arent Fox in San Francisco for our annual Medical Staff Leaders and the Law Conference.

A radical shift in public health policy forced NGOs and health organizations to make a choice: accept US family planning funds or secure alternative sources of funding.

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.

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

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.

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.

Please join Arent Fox in Costa Mesa for our seventh annual Medical Staff Leaders and the Law Conference.

Arent Fox Health Care partner and co-practice group leader Stephanie Trunk was nominated by corporate counsel to the 2018 Client Choice™ award list for the District of Columbia. Client Choice™ recognizes law firms and partners that stand apart for the excellent client service they provide.

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

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.