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Georgia Composite Medical Board Issues New Telemedicine Rules

The Georgia Composite Medical Board enacted a new regulation governing the standards for telemedicine practice. The regulation, titled Practice Through Electronic or Other Such Means, is found under Georgia Comp. Rules and...more

Whistleblower Receives More Than $17 Million in Omnicare Case

A decision has been made in the case against Omnicare, Inc. that will net a former Omnicare pharmacist more than $17.2 million in the ensuing settlement. The settlement with the Department of Justice orders Omnicare,...more

FBI Warning to Health Care Sector Holds True

In April of this year, the FBI issued a Private Industry Notification (PIN) to the health care industry warning of the “likely increase [in] cyber intrusions against health care systems.” In the same month, and into June of...more

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

Here Comes the Sunshine Act

The Centers for Medicare and Medicaid Services (CMS) released a guide for physicians to prepare for the Dispute Resolution period of the Physician Payments Sunshine Act. The CMS guide is available on the CMS Open Payments...more

Massive Data Breach Affects 4.5 Million Patients in 29 States

Community Health Systems, Inc. (the “Company”), one of the largest hospital organizations in the country, announced via a public filing (Form 8K) made yesterday with the Securities and Exchange Commission (“Report”) that the...more

Hospital Operator Reports 4.5 Million Patients’ Data Stolen in Cyberattack

The Tennessee-based acute-care hospital chain Community Health Systems, Inc. (CHS), reported on August 18 that information on approximately 4.5 million patients was stolen from the company. CHS is one of the largest hospital...more

4.5 Million Patients’ Information Stolen by Hackers

Community Health Systems Inc. (“CHS”), a Tennessee-based hospital provider, has reported it was the target of data hackers who were able to obtain identification information belonging to approximately 4.5 million CHS...more

Community Health Systems' HIPAA Breach: Significant Lessons for Health Care and Non-Health Care Companies

On August 18, 2014, Community Health Systems, Inc. (CHS) publicly confirmed, in a filing with the Securities and Exchange Commission (CHS filing), that its computer network was attacked between April and June 2014 by hackers...more

OIG Issues “Special Fraud Alert” on Lab Payments for Specimen Processing and Data Registry

On June 25, 2014, the OIG issued a Special Fraud Alert addressing compensation paid by laboratories to referring physicians. This Special Fraud Alert supplements prior OIG guidance which emphasizes that providing free or...more

Chinese Hackers Infiltrate Health System Network – Information of 4.5 Million Individuals Stolen

Community Health Systems, Inc. (“CHS”) reported yesterday that the information of approximately 4.5 million individuals has been affected by a Chinese cyber-attack. CHS and its affiliates own and operate 206 hospitals in 29...more

New Jersey DCA Extends Deadline for Prescription Blanks

On February 18, 2014, the New Jersey Division of Consumer Affairs (the “DCA”) adopted new regulations which incorporate print-based security features into all New Jersey Prescription Blanks (NJPBs). The DCA has recently...more

Health Care Update - August 2014 #3

In This Issue: - Stakeholders Urge FDA to Provide Clarity on Biosimilars - Ebola Crisis Continues - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

CMS Temporarily Suspends Open Payments System

On August 7, 2014, CMS announced via email that it has temporarily suspended the Open Payments system “to investigate a reported issue.” Although CMS did not offer further explanation, our understanding is that the system has...more

CMS Reopens Open Payments System After Rejecting One-Third of Reported Payments

The Centers for Medicare & Medicaid Services (CMS) announced last week that the Open Payments system was available again after it was taken off-line on August 3, 2014 to “resolve a data integrity issue.” Because the Open...more

Hospital Network Reports Large HIPAA Breach

Community Health Systems announced yesterday, August 18th, that hackers broke into its computers and stole data on 4.5 million patients. ...more

CMS Re-Opens Open Payments System

As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the...more

Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more

OIG Report Takes Issue With Oversight of Security Controls for Electronic Health Records

HHS Office of Inspector General (OIG) recently released a report concluding that the entity responsible for overseeing the testing and certification process for electronic health records (EHRs) did not fully ensure that...more

Federal Court Rejects Relator’s Swapping Allegations in False Claims Act Case

This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former...more

Health Alert (Australia) - August 18, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Queensland - 25 July 2014 (published 8 August 2014) - Cotterell v Redcliffe Assembly [2014] QCAT 357 - The...more

CMS Shuts Down Sunshine Act Online Verification Process

On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more

Continuing a Growing Trend, Telemedicine Efforts Move Forward

Last week, the American Telemedicine Association (ATA) approved its new telepathology guidelines, which provide updated guidance on specific applications, practices, benefits, limitations, and regulatory issues that may arise...more

Laboratory Payments to Physicians for Specimen Processing Present Substantial Risk of Fraud and Abuse

The United States Office of Inspector General (“OIG”) recently issued a “Special Fraud Alert” focusing on two potentially illegal trends that it has detected in arrangements between laboratories and their referring...more

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