Connecticut Enacts Legislation Intended to Curb Opioid Drug Abuse

On June 30, 2017, Connecticut Governor Dannel P. Malloy signed into law An Act Preventing Prescription Opioid Diversion and Abuse (Public Act No. 17-131). This legislation addresses opioid drug abuse in Connecticut by revising current laws related to controlled substance prescribing and disposal and enacting new laws regarding opioid abuse prevention and treatment.

We recently covered PA 17-131 in our Health Law Pulse, it can be accessed here.

Third Circuit Recognizes Escobar “Heightened Materiality Standard” in Dismissal of False Claims Act Case Tied to Avastin

In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower suit filed against pharmaceutical giant Genentech related to its billion dollar cancer drug Avastin. In Escobar, the Supreme Court upheld the validity—“at least in some circumstances”—of the “implied false certification” theory of FCA liability, and provided that this theory can attach where at least two conditions are met: a defendant must (1) make a specific representation on a claim for payment to the government, and (2) fail to disclose noncompliance with a material requirement for payment, which failure renders that representation a “misleading half-truth” (even if the representation is true on its face). Continue Reading

FTC Intervenes in Physician Practice Acquisition in North Dakota

On June 22, 2017 the Federal Trade Commission (FTC) filed an administrative complaint and a request for a preliminary injunction in federal court to block a proposed physician practice acquisition in North Dakota (the Transaction), the agency’s latest intervention in opposition to consolidation at the physician practice level. In this case, the FTC (accompanied by the Attorney General of North Dakota) opposes a proposed acquisition of Mid Dakota Clinic, P.C. (MDC) by Sanford Bismarck (a subsidiary of multi-state health system Sanford Health, collectively Sanford) on the grounds that the Transaction, if consummated, would represent an unfair method of competition in violation of Section 5 of the FTC Act (15 U.S.C. § 45) and may substantially lessen competition in violation of Section 7 of the Clayton Act (15 U.S.C. § 18). Continue Reading

The Joint Commission Releases Pain Assessment and Management Requirements

The Joint Commission (TJC) recently released new and revised pain assessment and management standards and elements of performance for its hospital accreditation program. These standards, effective January 1, 2018, follow an extensive review by TJC of current pain assessment and management guidelines compared with TJC’s standards. Continue Reading

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to notify the manufacturer of biologic reference products (Sponsor) that they intend to commercially market a biosimilar drug. The Court’s decision addresses two cases in the same opinion: Sandoz v. Amgen and Amgen v. SandozContinue Reading

NJ Gov. Chris Christie Seeks to Ease HIPAA Restrictions in Cases of Opioid Overdose

Last week, New Jersey Governor Chris Christie told reporters that he is in talks with representatives from the U.S. Department of Health and Human Services and the U.S. Department of Justice about easing HIPAA restrictions in situations where individuals have experienced an opioid overdose. Gov. Christie chairs the presidential commission on opioid abuse. Speaking to reporters, Gov. Christie expressed an interest in letting “parents and loved ones know when people have been reversed with Narcan,” referring to a prescription medicine that can be used to reverse an overdose. HIPAA generally prohibits the disclosure of health information to a patient’s family or friends without the consent of the patient, meaning that an individual’s parents or family might not be aware of situations where an individual has overdosed. A proposal to ease HIPAA restrictions is expected to be included in the commission’s interim report, which is scheduled to be released within the next few weeks.

This post is also being shared on our Data Privacy +Security Insider blog. If you’re interested in getting updates on developments affecting data privacy and security, we invite you to subscribe to the blog.

OCR Issues Reminder on Security Incidents

Following the frequent and varied ransomware attacks on health care entities over the past few years, the Office for Civil Rights (OCR) published guidance last summer to the health care industry reminding it that a ransomware attack could be a reportable breach under the HIPAA Breach Notification Rule. Despite the fact that many health care organizations were victims of ransomware attacks, the OCR commented that many of them did not report the incident or notify patients of the incident. Continue Reading

HHS Releases Health Care Industry Cybersecurity Task Force Report

This week, the Department of Health and Human Services (HHS) issued its “Report on Improving Cybersecurity in the Health Care Industry,” which is the culmination of a year-long effort on behalf of the Cybersecurity Task Force, made up of industry professionals from the public and private sectors to identify and develop recommendations “on the growing challenge of cyber-attacks targeting health care.” Continue Reading

Senate Proposes Expanded Use of Telehealth

On May 18, 2017, the Senate Finance Committee voted to move forward a bill entitled the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S870), which would increase access to telehealth services in the home.

Telehealth is the use of electronic information and telecommunications technology to support remote clinical healthcare, patient and professional health related education and other healthcare delivery functions.  Continue Reading

EHR Vendor Settles False Claims Act Suit for $155 Million

Electronic health record (EHR) vendor eClinicalWorks (eCW) recently entered into a settlement with the US Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG) to resolve allegations under the federal False Claims Act (FCA) that eCW misrepresented its software and paid customers kickbacks to promote its products. The settlement imposes joint and several liability for payment on the EHR Vendor and three of its founders for $154.92 million, and liability for settlement payments individually by a developer ($50,000) and two project managers ($15,000 each).  The settlement resolves a qui tam whistleblower action and the government’s complaint-in-intervention in United States ex rel. Delaney v. eClinicalWorks LLC, 2:15-CV-00095 (D. Vt.).   Continue Reading

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