Arent Fox LLP counsel Lanhee Chen recently was interviewed by the publication California Healthline, discussing what a Republican replacement plan to the ACA might look like. The full text of the article, originally published in California Healthline, can be read below or by clicking this link.
For Conservatives, It’s A New Day In Health Care
By Jenny Gold
December 19, 2016
Please join Arent Fox on Friday, February 3 from 7:00 AM – 5:00 PM Pacific for our annual Medical Staff Leaders and the Law Conference being held at the Avenue of the Arts Hotel in Costa Mesa.
About this Arent Fox Conference
This unique conference is dedicated to equipping your medical staff team with the most current skills, tools, and information to navigate challenging issues and provide effective leadership. This year’s conference will address recent legal and regulatory updates and explore significant new laws and cases impacting medical staffs. Among other topics, we will address SB 1177 and its impact on impaired physicians, as well as the latest developments relating to government investigations and compliance with the False Claims Act. We will also cover recent trends in medical staff litigation and explore the post-election impact of the new president and Congress on the health care industry.
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. Arent Fox health care partner Stephanie Trunk and associate Erin Atkins will be publishing a detailed client alert soon, in which they will analyze the provisions of the final rule and how they impact 340B covered entities and participating drug manufacturers. Please stay tuned to the Health Care Counsel blog for further updates!
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. TJC has been grappling with this issue for several years, having originally issued the ban in 2011, which was lifted in April and then reinstated in July of this year.
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. The FTC also alleged that Aura’s owner had provided a positive review and “five star” rating for the app without disclosing his connection to the company. A link to the FTC’s Press Release announcing the settlement can be found here.
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. See here for Arent Fox’s past coverage of the case.
ABOUT ARENT FOX LLP
Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.