Articles and Blogs

Executive Summary On August 22, 2014, the Drug Enforcement Administration (“DEA”) released its final rule rescheduling hydrocodone combination products (“HCPs”) from Schedule III to Schedule II of the Controlled Substances Act (“Final Rule”). This Final Rule went into effect on October 6, 2014 and applies to all persons who manufacture, distribute, dispense, import, export, engage…Read More

The Office of Federal Contract Compliance Programs (“OFCCP”) announced last week that it received approval to change its standard audit Scheduling Letter and accompanying Itemized Listing.  Together, these documents specify in detail what records and information federal contractors must supply to OFCCP when they are selected for a compliance review.  The changes are significant and…Read More

Executive Summary While the notion of malicious hacking of a medical device has been a recent topic in fictional  television shows, it became a public reality in October 2013 when former Vice President Dick Cheney revealed that his cardiologist modified Cheney’s heart defibrillator to disable a wireless feature and prevent hacking of the device. To…Read More

On October 8, 2014, CMS announced two initiatives with the objective of improving the quality of post-acute care.  Important to home health providers, CMS released a proposed rule that would revise the conditions of participation (“proposed COPs”) that regulate home health agencies.

Background Recent public comments to the Centers for Medicare & Medicaid Services (“CMS”) shed light on the frustrations faced by physician-owned hospitals trying to expand.  On July 14, 2014, CMS issued a proposed rule to make changes to the data sources that may be used for physician-owned hospital expansion requests under the physician self-referral regulations.1 The…Read More

This week, the Centers for Medicare & Medicaid Services (“CMS”) announced its intent to reopen the submission period for hardship exception applications for eligible professionals and hospitals participating in the Medicare Meaningful Use Program in order to avoid the 2015 Medicare payment adjustments for not demonstrating meaningful use of Certified Electronic Health Record Technology (“CEHRT”). The…Read More

Executive Summary On September 23, 2014, Michigan passed Public Act 285 (“Act”), which requires pharmacy technicians who perform certain functions to be licensed in the State of Michigan. Previously, individuals working as pharmacy technicians were not required to be certified or licensed to perform duties essential to their profession. In considering this new licensure requirement,…Read More

As American hospitals admit the first confirmed Ebola patient diagnosed in the U.S., and a second possible patient, providers and counsel need to work with their clients to prepare for the possibility of a patient presenting at their facility. Here are some considerations for initial steps: Update contact information for your local public health officer and legal…Read More

On Tuesday, September 30, CMS released data surrounding physicians and academic hospitals’ financial ties to drug and device makers.  The Open Payment website attempts to make public all payments to doctors and teaching hospitals by drug and medical device companies.  The payments range from meals to promotional speaking to research. The current online version of the…Read More

Over the past decade, hospitals have become increasingly regulated. In response, most hospitals have elected to implement corporate compliance programs. While these programs serve an important purpose, most fail to specifically address an area that is highly regulated – the leasing of hospital real estate. Managing hospital leasing arrangements can be extremely tedious work and…Read More