Fiscal Intermediary Advertising Review and Approval – Effective as of November 1, 2018

November 5, 2018

  Advertising materials intended to be used by Fiscal Intermediaries (“FIs”) in the Consumer Directed Personal Assistance Program (“CDPAP”) on or after November 1, 2018 must be submitted to the New York State Department of Health (“DOH”) for review and approval. On September 26, 2018, DOH issued guidance relating to the use of marketing materials …

Court of Appeals Affirms Lower Court’s Decision Striking Down “Soft Cap” on Executive Compensation

October 24, 2018

  On October 18, 2018, the New York Court of Appeals, in a 4-3 decision, affirmed an Appellate Division decision striking down the so-called “soft cap” and affirming the “hard cap” limitations on executive compensation under the NYS Department of Health (“DOH”) regulations implementing Executive Order # 38 (“EO 38”).  Specifically, the Court of Appeals …

OCR Provides New Guidance Regarding Mobile Devices and Electronic Media

October 8, 2018

  The OCR’s August 2018 Cyber Security Newsletter (the “Guidance”) highlights the importance of adopting specific policies regarding the effective management of mobile devices (e.g., cell phones, laptops) and electronic media (e.g., USB drives and CDs) containing PHI (collectively, “Electronic Devices”).  Historically, the OCR has repeatedly advised that Electronic Devices are particularly vulnerable to intrusion …

DOH Releases LHCSA Moratorium FAQs and Guidance on Registration Process

August 30, 2018

  The New York State Department of Health (“DOH”) recently issued two long-awaited documents in connection with the Licensed Home Care Services Agency (“LHCSA”) moratorium and registration process for LHCSAs. The State Budget for the State Fiscal Year (SFY) 2018-19 established a two (2) year moratorium on the processing and approval of applications seeking LHCSA …

Utilizing Electronic Health Record Data in Clinical Investigations

  On July 19, 2018, the Food and Drug Administration (FDA) finalized its draft guidance for clinical trial sponsors, investigators, contract research organizations, institutional review boards and others using electronic health record (EHR) data in FDA-regulated clinical investigations. Click Here to read entire Legal Alert. Garfunkel Wild can work with your organization to improve your …