On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that the district court did not have “the benefit of” the Supreme Court’s 2016 decision in Escobar at the time the suit was dismissed for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). Continue Reading
Public Act 17-241 — An Act Concerning Fairness in Pharmacy and Pharmacy Benefits Manager Contracts
Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and health care providers, and restrictions on contractual provisions between health care providers and insurance companies.
We recently covered PA 17-241 in our Health Law Pulse, it can be accessed here.
New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies
The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical research studies conducted at a non-profit medical center. In the advisory opinion, the OIG reiterated its longstanding concern about routine waivers of Medicare beneficiary cost-sharing amounts in the absence of financial hardship, and noted this can lead to liability under the anti-kickback statute (AKS). The research studies were conducted utilizing protocols under the Medicare Coverage with Evidence Development (CED) framework and involved a wound care system used to treat chronic, non-healing wounds.
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. Sandoz. Continue 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.
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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
