The 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties final rule is scheduled to be published in the Federal Register on January 5, 2017. A link to the advance copy of the final rule can be accessed here.
OFAC Expands General Licenses to Export Medical Devices, and Associated Services, to Iran; OFAC Also Redefines “Iranian-Origin” Goods Eliminating Its Unintended Capture of Goods Just Passing Through Iranian Ports and Airports
This article was originally published in Today's Wound Clinic. Editor’s Note: The following article discusses products characterized as “cellular and/or tissue-based products” (CTPs) by ASTM International. For purposes of this article, the legal and regulatory definition “human cells, tissues, and cellular- and tissue-based products” (HCT/Ps) – is used.
Just before Christmas, The Joint Commission (TJC) published an update clarifying its previous guidance regarding practitioners’ use of text messaging. TJC now says that practitioners may communicate with each other via secure text messaging systems. Practitioners are still banned, however, from issuing orders via text message, even though TJC’s previous concerns regarding data privacy and security were addressed.
Once again, a mobile medical app manufacturer has been caught in the Federal Trade Commission's enforcement web as a result of allegedly deceptive ad practices. Earlier this week, the FTC announced that Aura Labs, Inc. (doing business as AuraLife and AuraWare) agreed to settle charges that Aura violated the FTC Act by deceiving consumers with claims that its “Instant Blood Pressure (IBP)” app was as accurate as a traditional blood pressure arm cuff.
Late last week, the Attorneys General of 43 states announced that they reached a $19.5 million dollar agreement with Bristol-Myers Squibb Company to settle allegations that the company engaged in deceptive trade practices with respect to the marketing of a drug intended for treating schizophrenia.
On December 6, 2016, the Supreme Court determined in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby that violation of the statutorily mandated seal requirement, 31 U.S.C. § 3730(b)(2), in a qui tam False Claims Act case does not automatically require dismissal, but instead the district court has discretion to determine the appropriate sanction under the circumstances – whether it be dismissal or a less severe sanction.
Arent Fox’s Senior Government Relations Director Sonja Nesbit was recently published in American Health Lawyers Association (AHLA) Weekly in an article titled “The Outlook on Repealing and Replacing the ACA.” In the article, Sonja addresses the recent presidential election and the future of the Affordable Care Act (ACA).To read the AHLA article, click here.
On December 6, 2016, the American Hospital Association (AHA) and the Federation of American Hospitals (FAH), the two leading national hospital associations, sent a joint letter to Speaker of the House Paul Ryan and Senate Majority Leader Mitch McConnell about Congress’s approach to the ACA after President-elect Trump takes office. Both groups are essentially asking for protection from cuts in reimbursement that might take place in the process of repealing, replacing, or reforming the law.
Over two years after proposing rules for comment, the Office of Inspector General for the Department of Health and Human Services (OIG) just published a final rule which revises and adds new safe harbors to the Anti-Kickback Statute (AKS) and amends the definition of “remuneration” under the Civil Monetary Penalty (CMP) rules.