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Keeping you afloat amidst the rising sea of regulations

Late Night Budget Bill Contains Provisions of Interest to Big Pharma

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. Although the Act contains appropriations and budgetary provisions typical of such a bill, it also includes several provisions that are attracting the attention of pharmaceutical manufacturers, pharmacies, Medicare Part D Plans, and others in the industry.

Wait a Sec, I’ve Got a Text: CMS Clarifies Position Regarding Texting of Patient Information

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. Such clarification was needed: CMS’s individual guidance about texting had been uneven in 2017, with reports that CMS informed some facilities that texting any patient information was prohibited.

Is DOJ Changing Its Approach to Enforcement? What Regulated Entities Need to Know

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies—two published memos that restrict DOJ’s use of agency guidance, and one leaked memo that directs DOJ attorneys to consider moving to dismiss meritless qui tam (i.e., whistleblower) complaints brought under the federal False Claims Act.

Another One Bites the Dust: Court Tosses Nearly $350 Million False Claims Act Verdict Under Escobar

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act (“FCA”) award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court in United States ex rel. Escobar v. Universal Health Services, 136 S. Ct. 1989 (2016). Together with the Fifth Circuit’s recent decision in United States ex rel. Harman v.

FDA Ramps Up Transparency Initiative but Still Exploring Whether to Include CR Letters

On January 16, 2018, FDA Commissioner Scott Gottlieb, M.D., delivered a presentation, “Fostering Transparency to Improve Public Health” to the John Hopkins Bloomberg School of Public Health. In his presentation, Gottlieb provided a context for his vision of how transparency can be a “powerful tool for innovation,” discussing two new transparency-driven initiatives and one under consideration.

Medical Device Manufacturers Afforded Temporary Tax Relief

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.

New Jersey Clamps Down on Pharma Interactions with Prescribers

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” in an attempt to ensure that prescriber’s independent medical judgment is not unduly influenced by financial relationships with drug makers.

Chemical & Life Sciences Patent: Year In Review

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

Here’s Your Chance! OIG Seeking Proposals From the Health Care Industry on New Anti-Kickback Statute Safe Harbors and Fraud Alerts

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.

OIG Report Highlights Impact of Improper Drug Classification

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, which was conducted in response to a request from Congress to “evaluate the accuracy of manufacturer-reported drug classification data in the Medicaid rebate program.” The OIG determined that while the “vast majority” of some 30,000 drugs reimburs