Blogs / Events / Articles / News

Final Rule Issued: Stark Law Modifications Designed to Ease the Burden of Compliance

On October 30, 2015, the Centers for Medicare and Medicaid (“CMS”) issued a final regulation that includes modifications to the Stark Law (the “Final Rule”). Among other things, the Final Rule adds two new exceptions to the Stark Law’s prohibited referrals and clarifies regulatory definitions and requirements. These new regulations were...

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Medical Devices a Target for Online Hackers

In the past few years, medical devices have become a major target for online criminals. Not only are medical devices considered to be one of the easiest and most vulnerable points of entry into a health care enterprise, they are one of the most difficult areas to remediate even when an attack has been identified. Once infiltrated, hackers can use...

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OCR Audits to Begin in 2016

Beginning in 2016, the United States Department of Health and Human Services’ Office for Civil Rights (OCR) will conduct another round of audits to gauge compliance with privacy provisions in the Health Insurance Portability and Accountability Act (HIPAA). This announcement comes in the wake of criticism leveled against OCR for inconsistencies ...

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Controversial Cybersecurity Information Sharing Act Passes in Senate

This week, the Senate passed a cybersecurity bill, called the Cybersecurity Information Sharing Act of 2015 (the “CISA”), by a vote of 74 to 21. With the Senate’s vote, the bill is one step closer to becoming law. The CISA authorizes the Director of National Intelligence, the Department of Homeland Security, the Department of Defense, an...

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Effective November 1, 2015: New Jersey Expands Scope of Prescription Monitoring Program

In July, New Jersey Governor Chris Christie signed legislation that expands the access, registration, and utilization of the New Jersey Prescription Monitoring Program (NJPMP). The legislation, Senate Bill 1998 (S-1998), is slated to take effect on November 1, 2015. S-1998 is part of a larger effort in New Jersey to fight prescription drug abuse....

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Concierge Medicine – A New Frontier

Concierge medicine is a relatively new, but rapidly growing and evolving supplement to traditional medical care. A concierge physician charges an annual retainer fee that provides the patient with additional services that are not covered by insurance, but which enhance accessibility, the amount of time spent with the physician, and hopefully a mu...

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OIG Issues Advisory Opinion No. 15-12: Free Home Health Provider Visits Do Not Violate Anti-Kickback Statute

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a new advisory opinion finding that free introductory visits (the “Introductory Visits”) for patients offered by a home health care provider (the “Requestor”) would not violate the Anti-Kickback Statute (“AKS”) or the Civil Monetary Pen...

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Physician Group Practice Pays $750,000 for Breach of Unsecured Electronic Protected Health Information on Electronic Device

Cancer Care Group, P.C. (“CCG”), a radiation oncology physician group practice in Indiana, agreed to pay $750,000 for a breach of unsecured electronic protected health information (“ePHI”). CCG will also implement a corrective action plan. The breach occurred in 2012 when a CCG employee’s unattended laptop bag was stolen from a car. T...

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Hospital Pays $218,400 to OCR for HIPAA Violations

St. Elizabeth’s Medical Center (“SEMC”), a tertiary care hospital in Brighton, Massachusetts, has agreed to pay $218,400 to the Office for Civil Rights (“OCR”) to settle alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). SEMC will also implement a corrective a...

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21st Century Cures Act Passes House: Could Usher In Broad Reforms to Drug Approval Process

On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures Act” (the “Act”) would foster significant regulatory changes in the introduction of new drugs to th...

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