Earlier this year the enhanced Nurse Licensure Compact (eNLC) was implemented in all 29 participating states including Colorado, West Virginia and Kentucky. Illinois[1] and Michigan[2] are among the states with current legislation pending to adopt the eNLC, while Indiana, Ohio, Pennsylvania, California and a handful of other states do not yet have pending legislation ...
The State Medical Board of Ohio (Medical Board) recently released proposed rules that will create a non-disciplinary, confidential monitoring program for licensees with mental or physical illnesses. Historically, licensees with a mental or physical illness could not only be subject to formal disciplinary action pursuant to the Medical Board’s rules, but the licensee’s mental or physical illness became public information as a result of the disciplinary process ...
As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its efforts in the FCA arena. The first, entitled, “Factors for Evaluating Dismissal Pursuant to 31 U.S.C ...
Last year the Colombian Congress issued Law 1841, which incorporated the Free Trade Agreement (“FTA”) between Colombia and Israel into the Colombian legal system. Currently, the law approving the Treaty is under review by the Colombian Constitutional Court for its definitive entry into force ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...
Country overview 1. Give an overview of the country’s economy, its structure and main characteristics, and prevailing government economic policy, particularly as regards foreign investment. The Philippines is an archipelago composed of more than 7,000 islands with 82 provinces divided in 18 regions. Rich in natural resources, it has a total land area of about 300,000 square kilometres. It is divided into three major island groups: Luzon, Visayas and Mindanao ...
One of the many unresolved issues relating to Brexit is the issue of cross-border retailing. While there are certainly issues relating to online cross-border shopping (e.g., the imposition of VAT, additional charges for checks as well as delays caused by possible border/customs delays), there are certainly plenty of issues relating to cross-border bricks and mortar retailing as well. The border between Ireland and Northern Ireland ("NI") is a neat case study ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
Ohio prescribers need to be aware of new rules for prescribing controlled substances that will take effect on December 29, 2017. First, prescribers will be required to include the first four characters of the ICD-10 diagnosis code or the full CDT procedure code on all prescriptions for opioids.[1] Similarly, beginning June 1, 2018, prescribers will need to include the ICD-10 diagnosis or CPT procedure code on prescriptions for all other controlled substances ...
Governor Jerry Brown approved California Senate Bill 798 on October 13, 2017. One provision of this bill imposes penalties for failure to file required reports under Business and Professions Code Section 805.01. Beginning January 1, 2018, individuals and entities with reporting obligations under Section 805.01 are subject to fines of up to $100,000 per violation for willful failures to file a Section 805 ...
International financial records recently stolen from two offshore services firms and 19 corporate registries maintained by governments were leaked to journalists and their details subsequently published around the world. But beyond the hype, however, we find no intelligent inferences of legal significance in the reporting. For example, the media draws attention to a United States Cabinet member's offshore financial transactions but does not allege that his shipping stake was illegal ...
The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2 ...
ANGOLA: Introduction of transfer pricing unitA transfer pricing unit, set up as an administrative technical structure forming part of the Large Taxpayers Directorate of the General Tax Administration, was launched on 25 September 2017 and will be responsible for monitoring compliance with Angola’s transfer pricing regime introduced by Presidential Decree No.147/13 of 1 October 2013 ...
Latin America’s current economic growth levels are among the world’s highest, and the region is preparing its regulations to meet new economic challenges. As such, the fostering of foreign trade and foreign direct investment (FDI) is important to increase GDP growth, create job opportunities, and improve logistics and production ...
On October 13, 2017, Governor Brown signed SB 798, amending Business and Professions Code Section 805, Civil Code Sections 43.7 and 43.8, and Evidence Code Section 1157 to include licensed midwives within their scope. Notably, these changes only apply to licensed midwives, those professionals who pass the North American Registry of Midwives examination and are licensed by the Medical Board of California ...
The Trump Administration has followed up on the President’s speech in Miami regarding U.S. policy toward Cuba by announcing new restrictions on trade with Cuba that became effective at the end of 2017. At the heart of the new policy is a “Cuba Restricted List” in which the State Department names 180 Cuban entities with which new commercial relations are to be prohibited ...
View a PDF of the November 2017 edition of the Haynes and Boone Health Law Vitals newsletter. FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues, or organs with the goal of restoring or establishing normal function ...
Last month, the UK Financial Conduct Authority (FCA) published its "Regulatory Sandbox – Lessons Learned Report". In the Report, the FCA evaluated the progress of the UK financial regulatory sandbox during its first year of operation and tentatively concluded that the initiative has so far been a success ...
Earlier this year, Michigan’s Department of Licensing and Regulatory Affairs (LARA) announced the formation of “work groups” to provide input as LARA adopts emergency rules to govern activities under the State’s new Medical Marihuana Facilities Licensing Act (MMFLA). Organized around the MMFLA’s five license types, those work groups met last month ...
