On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a pre-publication copy of the Clinical Laboratory Fee Schedule (CLFS) proposed rule. The proposed rule restructures payment rates for clinical diagnostic laboratory tests (CDLTs) and advanced diagnostic
September 2015
Challenge dropped to dismissal of allegations of pharmacy-reward fraud
A relator is dropping his appeal of a district court decision that granted a motion to dismiss FCA claims against CVS. Procedural deficiencies were raised with relator’s appeal, including missing the filing deadline for his appeal in the U.S. Court…
Florida hospital pays $69.5 million to settle alleged Stark issues
The government has announced that a South Florida hospital district will pay $69.5 million to settle False Claims Act allegations related to financial arrangements with physicians.
This case follows the trend of increased scrutiny of physician compensation, both by whistleblowers …
DOJ announces new policy on prosecuting corporate individuals
Introduction
On Wednesday September 9, 2015, the U.S. Department of Justice (“DOJ” or the “Department”) issued a memorandum entitled “Individual Accountability For Corporate Wrongdoing” (the “Memo”) outlining specific policy measures intended to empower U.S. prosecutors further in their pursuit of…
FDA mandates proactive prevention approach to food safety in Preventive Controls for Human and Animal Food Final Rules
Following extensive outreach with the stakeholder community and publication of four notices of proposed rulemaking, on September 10, 2015, the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) issued the much anticipated Final Rules…
Federal judge rules House can pursue claims regarding ACA spending
On Wednesday, a federal district court in Washington, DC ruled that the House of Representatives had standing to bring claims against the Obama administration regarding healthcare spending under the Affordable Care Act. That is, the court found that the House…
Government agencies propose updates to Common Rule to better protect human research subjects
On September 2, the US Department of Health and Human Services (HHS), along with 15 other government agencies, proposed changes to the Common Rule, to enhance protections for individuals involved in research, while modernizing rules and improving efficiency. The rule…
HHS issues proposed rule implementing ACA civil rights protections
Today, the Department of Health and Human Services (“HHS”) issued a long-awaited proposed rule implementing Section 1557 of the Affordable Care Act (“ACA”), which makes clear that the ACA’s extension of civil rights protections against sex discrimination in health programs…
Kim Kardashian posts corrective ad on Instagram
Kim Kardashian is promoting Diclegis® on social media once again. But this time, she is posting about the drug to correct her prior actions.
On August 12, we discussed Kim Kardashian’s Instagram and Facebook post in which she discussed the…
Chipotle sued for non-GMO claims
A California woman has filed a class action lawsuit in federal court against Chipotle Mexican Grill, Inc. (“Chipotle”) taking issue with Chipotle’s ads touting its restaurants as serving only ingredients that are free from genetically modified organisms (“GMOs”).
Colleen Gallagher…