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Keeping you afloat amidst the rising sea of regulations

New CMS System to Report Average Sales Price (ASP) Data for Part B Drugs

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. Manufacturers must begin to use this system to report ASPs for their Medicare Part B eligible drug products beginning with the Q2 2018 reporting, due April 30, 2018. For Q2 2018 only, the data also must be sent using the current manual process, which will be replaced by the electronic system permanently beginning with the Q3 2018 ASP submission.

Fighting the Opioid Epidemic: New DOJ Prescription Interdiction & Litigation Task Force To Target Drug Manufacturers & Distributors

On February 27, 2018, Attorney General Jeff Sessions announced the launch of the Prescription Interdiction & Litigation Task Force (PIL Task Force), which will use criminal and civil law enforcement tools to combat the nation’s opioid epidemic, specifically targeting drug manufacturers and distributors. This is the latest development in the government’s increasing focus over the past year on the opioid epidemic.  

Recently-Passed CHRONIC Act Allows for Increased Medicare Coverage for Telehealth Services

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.

Patent Office’s Rulebook Update Supports Personalized Medicine Claims

Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.1 At best, patent owners and applicants with such claims are experiencing mixed results in district court and the Patent Office. And, to date, the Federal Circuit has not issued a precedential decision involving a subject matter eligibility challenge of personalized medicine. However, the Patent Office’s recent update to its Manual of Patent Examining Procedure (MPEP) could signal a turning point for life science companies.

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.