Category: Uncategorized

Washington Update: Senate proceeds towards “Cures”; CMS releases MA rates and Call Letter

Health care policy issues continue to stream out of Congress and the Administration.  The Senate held a markup of  various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st Century Cures legislation and CMS released long awaited Medicare Advantage rates.

Heath Provisions in President’s Budget Take Aim at Drug Prices and Opioid Abuse

Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office.  While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions worth noting because of their current newsworthiness and possible reemergence in future policy debates.  Moreover, proposals directed at addressing the […]

Senator Calls on Med Device Leaders to Improve Cybersecurity

Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in their medical devices.  From the letter, the rationale for selecting these companies is that together they “control more […]

ALJ Upholds OCR Enforcement Against Lincare, Inc. of $239,800

A U.S. Department of Health and Human Services (HHS) administrative law judge (ALJ) recently sustained an earlier HHS Office of Civil Rights (OCR)  decision to impose a civil money penalty (CMP) of $239,800 against Lincare Inc. (Lincare) in  connection with HIPAA violations discovered after a breach of patient records.  This is only the second time […]

FDA Issues Draft Guidance on Medical Device Cybersecurity

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” (the Guidance) that sets forth ways in which medical device manufacturers should monitor and address cybersecurity risks.  The Guidance is the latest manifestation of a federal agency weighing in on the continually […]