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REMINDER: Annual Reporting Deadline Approaches for Connecticut Hospitals and Hospital Systems

Hospitals and hospital systems in Connecticut must file annual reports by January 15, 2018 describing (1) the activities of their group practices (e.g., medical foundations or faculty practice plans), and (2) their respective...more

CMS Approves Laboratory Alerts to Physicians in Rare Stark Law Advisory Opinion

The Centers for Medicare & Medicaid Services (CMS) issued a rare advisory opinion (CMS-AO-2017-1) under the Stark Law (Section 1877 of the Social Security Act, codified at 42 U.S.C. § 1395) earlier this fall, addressing a...more

FTC Granted Preliminary Injunction to Block Physician Practice Acquisition

On December 13, 2017 a magistrate judge in the U.S. District Court for the District of North Dakota granted a request of the Federal Trade Commission (FTC) and North Dakota Attorney General to preliminarily enjoin Sanford...more

Fourth and Fifth Circuits Rely on Escobar to Render Important Fraud Decisions

Recent decisions in the Fourth and Fifth Circuit Courts of Appeals demonstrate the central role that the Supreme Court’s Escobar decision continues to play in fraud litigation despite, or as a result of, continued uncertainty...more

CMS Addresses Lingering Uncertainties and Raises Others via MACRA Information Blocking Guidance

The Centers for Medicare & Medicaid Services (CMS) recently issued guidance intended to help clinicians eligible for the Merit-based Incentive Payment System (MIPS) navigate an attestation required thereunder concerning the...more

Data Privacy + Cybersecurity Insider - October 2017 #3

Security researchers this week have found a new vulnerability that affects Wi-Fi Protected Access II, also known as WPA2, which is the security protocol used by many wireless networks. The vulnerability, Key Reinstallation...more

Supreme Court to Hear Microsoft Emails Case

In an order issued on October 16, 2017, the U.S. Supreme Court granted certiorari in United States v. Microsoft Corporation, a case with potentially far-reaching implications for the privacy of electronic data maintained by...more

Supreme Court to Discuss Granting Review in Microsoft E-Mails Case October 6

The U.S. Supreme Court recently indicated that it will consider the federal government’s petition for a writ of certiorari in United States v. Microsoft Corp. at its conference scheduled for October 6, 2017. United States v....more

FTC Issues ‘Stick with Security’ Guidance Emphasizing Data Security Best Practices

The Acting Director of the FTC’s Bureau of Consumer Protection, Thomas B. Pahl, recently commenced a ‘Stick with Security’ series of blog posts that analyze the data security principles championed by the FTC in its Start with...more

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

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...more

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

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...more

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...more

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...more

Solicitor General Urges Supreme Court Review of Second Circuit Microsoft Decision

On June 23, 2017, the Office of the Solicitor General (OSG) filed a petition for a writ of certiorari with the United States Supreme Court requesting reversal of a 2016 decision in which the U.S. Court of Appeals for the...more

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...more

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...more

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...more

HHS Office of the Assistant Secretary for Preparedness and Response Issues Series of Cybersecurity Updates in Response to WannaCry...

In response to the WannaCry ransomware attack that infiltrated the computer systems of health care systems and other entities worldwide on or around May 12, 2017, HHS’ Office of the Assistant Secretary for Preparedness and...more

New Mexico Enacts Data Breach Notification Law

Governor Susana Martinez recently signed into law the New Mexico “Data Breach Notification Act” (the Act), making New Mexico the 48th state (plus Puerto Rico and the District of Columbia) to adopt legislation mandating the...more

NY AG Announces Settlements with Three Mobile-Health App Developers Over Privacy, Marketing Concerns

On March 23, 2017, New York State Attorney General Eric T. Schneiderman announced settlements with three mobile health application (app) development companies aimed at curbing deceptive marketing practices and inadequate...more

Florida Supreme Court Rejects PSQIA Preemption of Florida Constitution

On January 31, 2017, the Florida Supreme Court held that adverse medical incident reports produced in accordance with Florida law cannot constitute confidential and privileged patient safety work product (PSWP) under the...more

Second Circuit Denies En Banc Rehearing in Microsoft Email Case

On January 24, 2017, the U.S. Court of Appeals for the Second Circuit denied the Department of Justice’s request for an en banc rehearing in In the Matter of a Warrant to Search a Certain Email Account Controlled and...more

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

OIG Recognizes New Local Transportation Safe Harbor and Exceptions to CMP in Updated Fraud and Abuse Regulations

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more

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