On May 14, 2015, four New Jersey legislators introduced the Out-of-Network Consumer Protection, Transparency, Cost Containment and Accountability Act (the "Legislation"). If enacted, the Legislation would increase health care...more
The Office of the National Coordinator for Health Information Technology (ONC-HIT) released version 2.0 of its Guide to Privacy and Security of Electronic Health Information (the Guide). While the Guide clearly states that it...more
On April 27, 2015, the U.S. Department of Health and Human Services (HHS) announced that Cornell Prescription Pharmacy (CPP), a single-location pharmacy in the Denver, Colo. metropolitan area, agreed to settle alleged HIPAA...more
On April 16, 2015, President Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 ("the Act"). The national headlines about the Act’s passage focused on the repeal of the sustainable growth rate...more
On Tuesday, March 10, 2015, the U.S. Department of Health and Human Services ("HHS") announced the introduction of the Next Generation Accountable Care Organization ("ACO") Model of payment and care delivery. ACOs...more
On January 26, 2015, the U.S. Department of Health and Human Services ("HHS") announced the launch of the Better Care. Smarter Spending. Healthier People: Why it Matters initiative. According to HHS, this is the first time...more
2/2/2015
In a final rule published in the Federal Register on November 13, 2014, the Centers for Medicare and Medicaid Services (CMS) eliminated the federal Sunshine Act reporting exclusion for payments to physicians at continuing...more
The U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on December 8, 2014 that a community behavioral health organization agreed to pay $150,000 and adopt a corrective action plan to...more
In early November 2014, the New Jersey Department of Health (DOH) sent a letter to every physician licensed by the New Jersey Board of Medical Examiners (BME) regarding New Jersey’s statutory requirement that every surgical...more
On October 17, 2014, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services, Office of Inspector General (OIG) published in the Federal Register (79 FR 62356 et seq) a notice...more
In the Friday, October 3, 2014 issue of the Federal Register (79 F.R. 59717 et. seq), the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) to...more
10/9/2014
There are two important updates with respect to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). First, on September 17, 2014, the U.S. Department of Health and Human Services (HHS) issued guidance to...more
On August 15, 2014, the Centers for Medicare and Medicaid Services (CMS) re-opened the Open Payments system for physicians and teaching hospitals to register, review, and, if needed, dispute information gathered to date. CMS...more
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
In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more
The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that includes a plan to eliminate the continuing medical education (“CME”) exclusion to the reporting requirements under the federal Physician...more
On June 11, 2014, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued two reports to Congress summarizing activities in calendar years 2011 and 2012. The Annual Report to Congress on...more
In the May 23, 2014 issue of the Federal Register (79 FR 29732), the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) that would change the so-called meaningful use stage...more
On April 26, 2014, the Federation of State Medical Boards (FSMB) House of Delegates adopted The Model Policy on the Appropriate Use of Telemedicine Technologies (FSMB Telemedicine Policy). FSMB is a national organization of...more
On April 9, 2014, the Centers for Medicare and Medicaid Services (“CMS”) released the Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File (the “Data File”). The Data File contains...more
On March 28, 2014, the U.S. Department of Health and Human Services (“HHS”) announced the release of a security risk assessment (“SRA”) tool to assist small- to mid-sized providers in conducting risk assessments of their...more
The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released guidance on its website describing a two-phase process for applicable manufacturers and group purchasing organizations (“GPOs”) to register and submit...more
In the December 27, 2013 edition of the Federal Register, the Office of Inspector General (“OIG”) and Centers for Medicare and Medicaid Services (“CMS”), both within the U.S. Department of Health and Human Services (“HHS”),...more
One day after Christmas, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced that a Massachusetts-based dermatology practice (Practice) agreed to a $150,000 payment and entered into a...more