In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...
Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...
Don Stuart, a partner in Waller’s Tax Practice Group and current Chair of the Tax and Finance Practice Group of the American Health Lawyers Association (AHLA), and Kim Looney, partner in the firm’s Healthcare Compliance and Operations group, are authors on two chapters in the AHLA’s new publication The ACO Handbook: A Guide to Accountable Care Organizations, Second Edition ...
On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) Innovation Center released its newest model in alternative care delivery: the Next Generation ACO Model. This new version of accountable care organization (ACO) builds upon the experiences from the Pioneer ACO Model and the Medicare Shared Savings Program (MSSP) to set more predictable financial targets, enable providers and beneficiaries to better coordinate care, and provide overall high quality care ...
In an opinion that will certainly cause Texas hospitals, physicians, nursing home operators and other healthcare providers to consider whether they should insert standard arbitration clauses into their pre-treatment agreements, the Texas Supreme Court held last week that the Federal Arbitration Act (“FAA”) preempts the more stringent arbitration requirements set forth in the Texas Medical Liability Act (“TMLA”).The Fredericksburg Care Co., L.P. v. Juanita Perez et al, No. 13-0573, 2015 Tex ...
On February 26, 2015, the Supreme Court of Canada dismissed Dr. Gilbert Liu's application for leave to appeal a Court of Appeal decision concerning the time limit for handling complaints from users of health institutions ...
Download a free copy of the Philippine section of Getting the Deal Through: Life Sciences 2015, which was contributed by SyCipLaw partners Rose Marie M. King-Dominguez and Carlos Roberto Z. Lopez with senior associate John Paul V. de Leon and associate Mark Xavier D. Oyales.This chapter is reproduced with permission from Law Business Research Ltd ...
Under Regulation No. 122/M-IND/PER/12/2014 on Delegation of Authority to Grant Industrial Business Licenses to the Head of the Capital Investment Coordinating Board, the MOT has delegated its authority to issue certain licenses to BKPM. Business licenses delegated consist: 1. Industrial Business License and/or Expansion Licenses as follows: a. alcoholic beverages industry; b. valuable paper industry; c. weapons and ammunition industry; d ...
In recent years, the Department of Justice, the FDA and the FBI have stepped up enforcement of the Food Drug and Cosmetic Act’s (FDCA) drug importation, distribution and misbranding requirements particularly with respect to high-priced and difficult-to-obtain drugs used in cancer treatment. Recently, these efforts suffered an unexpected setback in the Sixth Circuit following the United States’ decision to abandon its prosecution against an East Tennessee Oncologist and his wife ...
The Head of the National Agency for Food and Drug Control (BPOM) has issued Regulation No. 11 of 2014 on The Procedure for the Certification of Good Manufacturing Practices, ensuring compliance with the applicable standards for processed food. Regulation 11 has been in force since 5 August 2014 ...
On December 1, 2014, the Department of Health and Human Services Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that included numerous changes for accountable care organizations (“ACOs”) participating in the Medicare Shared Savings Program (“MSSP”) in light of the experience CMS gained during the first two years of the program ...
In an opinion published on November 11, 2014, Connecticut joined a growing number of jurisdictions that have found that state law causes of action based on a health care provider’s unauthorized disclosure of a patient’s medical records are not preempted by the Health Insurance Portability and Accountability Act (“HIPAA”) ...
Last week, Waller launched an Ebola legal resource website. Since then, we have received positive feedback from our clients, follow-up questions and suggestions for additional topics we should cover. As the needs of our clients continue to evolve, we are updating the site regularly ...
How do we discipline employees that refuse to work due to the Ebola virus? What patient information is protected during an outbreak? How should we communicate with our employees about Ebola? Has OSHA issued new guidelines on Ebola for healthcare providers? These are just a few of the questions we are hearing from our clients ...
With the recent announcement to extend the waivers of certain fraud and abuse laws for accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP), ACOs can continue using the waivers in their current form - at least for now ...
On October 3, 2014 the Department of Health and Human Services, Office of Inspector General (“OIG”), released a proposed rule to add new safe harbors to the Anti-Kickback Statute (“AKS”) and to amend the definition of “remuneration” in the Civil Monetary Penalties (“CMP”) regulations. The OIG additionally solicited comments on same which must be submitted no later than 5 pm EST on December 2, 2014 ...
On October 3, 2014, the Supreme Court of Canada, by a majority decision of 5 to 4,1 confirmed that a disposition ordering the treatment of an accused who is found unfit to stand trial requires the prior consent of the designated hospital to all the terms of the disposition order, inclusive of the date on which the treatment is to begin ...
The Energy Law is to permit industrial users to obtain certificates of origin and present them for redemption for only a portion of the electricity they purchase. But the future of this support mechanism has been called into question. The rule introduced by the 26 July 2013 act amending Poland’s Energy Law limits the obligation imposed on industrial users to support the generation of electricity from renewable energy sources (RES) and high-efficiency cogeneration (CHP) ...
In an unanimous decision dated September 4, 20141 , the Court of Appeal confirmed that the 45-day time limit under the Act Respecting Health Services and Social Services2 (ARHSSS) to allow the medical examiner and the local service quality and complaints commissioner to process a user complaint is not mandatory but rather serves to indicate that the Legislator intends the complaint to be diligently processed ...
The draft regulations for OTC derivatives have been released, which means that change is in the air. The government is stepping forward into unchartered territory and is set to regulate an area which has never been regulated before. Following our recent breaking news on the draft regulations, ENSafrica will, over the coming weeks and months, unpack the regulations for you, highlighting all the essentials. What follows is a sneak peak at affected areas and a snapshot of the bigger picture ...
On July 16, 2014, the Sixth Circuit Court of Appeals confirmed that a “health care provider can bring the Medicare Secondary Payer Act’s (“MSP’s”) private cause of action against a non-group health plan that denies coverage for a reason besides Medicare eligibility.” In Michigan Spine & Brain Surgeons, PLLC v. State Farm Mutual Automobile Insurance Co., the Court clarified a key holding in its prior decision in Bio-Medical Applications of Tennessee, Inc. v ...
