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Keeping you afloat amidst the rising sea of regulations

FDA Regulation of HCT/Ps: What Wound Care Practitioners Need to Know

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.

To Text or Not to Text . . . That is the Question: TJC Publishes Updated Guidance for Healthcare Providers

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.

Under Pressure: Mobile Medical App Settles Deceptive Ad Charges

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.

Bristol-Myers Settlement Illustrates Continuing Enforcement Trend Against Allegedly Deceptive Promotion of Medical Products

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.

Supreme Court Declines to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement

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.

Sonja Nesbit Published in AHLA Weekly

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. 

AHA and FAH Send Joint Letter to Congressional Leaders on ACA Reform

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.

New Final Regulations Provide Overdue Guidance on Permissible Arrangements Between Providers, Financial Relief for Patients

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.

The Drug Pricing Conundrum Explained

Counsel Lanhee Chen recently authored “The Drug Pricing Conundrum Explained” for RealClear Health. The article describes the recent significant discussions on drug pricing and the reality that employers, pharmacy benefit managers (PBMs), and health plans are working to ensure a competitive marketplace and hold down costs for consumers. Lanhee states that the US continues to be a center for pharmaceutical innovation and a leading source of new cures that improve human quality of life and longevity.

US Attorney Announces Kickback and False Claims Act Settlement with Device Manufacturer BioTelmetry/MedNet

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the company’s cardiac monitoring services.