Joel D. Gottesman

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CMS Announces Final Rule Updating Fire Safety for Healthcare Facilities

Photo of Joel D. GottesmanBy Joel D. Gottesman on Posted in Uncategorized
The Centers for Medicare and Medicaid Services (CMS) recently published a final rule updating fire safety requirements for healthcare facilities in an effort to increase patient safety and adapt to the needs of an aging population. The new rule adopts provisions of the National Fire Protection Association’s (NFPA) 2012 edition of the Life Safety Code (LSC), as … Continue Reading

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

Photo of Lance L. SheaPhoto of Joel D. GottesmanBy Lance L. Shea and Joel D. Gottesman on Posted in Uncategorized
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The guidance, titled Postmarket Management of Cybersecurity in Medical Devices (Postmarket), is intended to clarify the FDA’s recommendations and emphasize the importance of monitoring, identifying, … Continue Reading

Health System Free Transportation Program Does Not Warrant Sanctions, Says OIG

Photo of Joel D. GottesmanBy Donna S. Clark and Joel D. Gottesman on Posted in Uncategorized
The Office of Inspector General (OIG) recently issued Advisory Opinion 15-13, addressing whether an integrated health system (Health System) was at risk for administrative sanctions under the federal anti-kickback statute or civil monetary penalty law for offering free shuttle services to patients. The OIG concluded that the proposed transportation arrangement presents minimal risk of fraud … Continue Reading

DOL Final Rule Withstands Challenge, Mandates Changes for Home Health Employers

Photo of Joel D. GottesmanBy Joel D. Gottesman on Posted in Uncategorized
The U.S. Court of Appeals for the D.C. Circuit recently reinstated regulations from the U.S. Department of Labor (DOL), extending federal minimum wage and overtime requirements to home health workers employed by third-party employers. Home Care Association of America v. Weil, No. 15-5018 (Aug. 21, 2015) concerns plaintiffs-appellees Home Care Association of America (Home Care) … Continue Reading

Second Circuit Finds Member Associations Have Standing to Bring Claims on Behalf of Members

Photo of Joel D. GottesmanBy Joel D. Gottesman on Posted in Uncategorized
Last month the Second Circuit Court of Appeals reversed the U.S. District Court’s decision to deny the New York State Psychiatric Association (NYSPA) standing in its claim against UnitedHealth Group and related entities (UnitedHealth).  In doing so, the court opened the doors for member associations to bring claims on behalf of its members for violations … Continue Reading
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