News

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, D.C., on October 4-5, 2018. The purpose of this and other public meetings of MedPAC is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to...

Recent comments by the Federal Trade Commission (FTC) Commissioner Rohit Chopra should have companies on notice for increased enforcement actions across the board. During the “Privacy. Security. Risk.” Conference in Texas last week, Chopra made comments regarding his views on increasing enforcement, including the imposition of...

On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or...

On October 10, 2018, President Donald Trump signed into law the “Know the Lowest Price Act” and the “Patients’ Right to Know Drug Prices Act,” which aim to improve consumer access to drug price information by banning gag clauses. The Trump administration previously announced its...

On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions.  Among these actions, the most significant was the issuance of a revised draft guidance...

On October 16, 2018 the Department of Health and Human Services Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) announced an update to their previously provided Security Risk Assessment Tool.  According to ONC and OCR, the...

The FDA issued a new Draft Guidance today to ensure medical devices – an increasing potential target for hackers – are better protected from unauthorized digital access. According to the FDA’s draft guidance issued today, “Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting...

On September 28, 2018, the U.S. Food and Drug Administration (FDA) released two draft guidances for industry. The purpose, according to FDA Commissioner Scott Gottlieb, M.D., is to modernize the approach to clinical trial design in efforts to (1) make clinical trials more efficient while...

Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available about a drug’s safety and benefits.  The two draft guidances address, respectively, adaptive designs and master protocols.  This blog post discusses FDA’s...

The American Clinical Laboratory Association (“ACLA”) challenged the final rules promulgated by the Department for Health and Human Services (“HHS”) pertaining to how the Medicare Clinical Laboratory Fee Schedule (“CLFS”) payment rates are established for laboratory services (Am. Clinical Lab. Ass’n v. Azar, No. 17-2645...