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) ...
Last month, CMS issued a proposed rule that would drastically expand the agency’s authority to further its program integrity efforts through the provider and supplier enrollment process. This proposed rule, referred to as CMS-6058-P, (located in the Federal Register at 81 Fed. Reg. 40 ...
In a landmark victory for Federally-qualified health centers, a California Court of Appeal confirmed last October that federal and state law requires the State of California to pay FQHCs “100 percent” of their costs of furnishing core and other ambulatory services to Medi-Cal beneficiaries. (Tulare Pediatric Health Care Center v. State Department of Health Care Services (2nd Dist. 2019) 41 Cal.App.5th 163 ...
On January 28, 2019, the California Department of Social Services issued a letter informing all licensed Residential Care Facilities for the Elderly that Title 22, Section 87224 of the California Code of Regulations has been revised. Section 87224 previously provided for a 30-day eviction notice to residents upon the change of use of a facility. This notice period was inconsistent with the applicable statute, Health and Safety Code Section 1569.682(a)(2) ...
September 26, 2023 By: Carol K. Lucas Effective January 1, 2024, health care entities in California that propose to enter into “material change transactions” will be required to provide advance written notice to the California Office of Health Care Affordability (“OCHA”) ...
Starting next year, California residents who don’t have health care coverage could face a state tax penalty. Under the new Minimum Essential Coverage Individual Mandate, California residents who fail to maintain minimum essential coverage for themselves and their dependents could owe a state tax penalty, unless they qualify for an exemption ...
Effective Today, the California Department of Public Health (CDPH) will no longer require vaccinated individuals to wear masks in all indoor public settings under its updated Guidance for the Use of Face Masks (Updated Guidance). This effectively lifts the indoor mask mandate in most California counties, both where local officials have aligned with CDPH Guidance, and where officials never issued their own local mask mandate ...
Key Points As of January 1, 2022, skilled nursing facilities are not limited to hiring licensed nurses to fill the role of infection preventionist. California still requires the total time dedicated to the infection preventionist role be full-time. In January 2021, Assembly Bill (AB) 2644, codified as Health & Safety Code Section 1255 ...
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 ...
Article PDFJust when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018 ...
October 18, 2023 By: Leah Lively California Governor Gavin Newsom recently signed SB 525 into law, which amends the California Labor Code to set industry minimum wage requirements for nearly all healthcare workers, whether they are hourly or salaried employees, or independent contractors. The law also provides these workers with an independent private right of action to enforce these minimum wage requirements ...
SB 977 was passed by the California Senate on June 26, 2020. If the bill is passed by the Assembly and becomes law, it will require health care systems, private equity groups, hedge funds, and academic medical centers to obtain advance approval by the California Attorney General for substantially all acquisitions or change of control transactions with health care facilities and providers ...
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 ...
Earlier this year, in Kim v. Toyota Motor Corp., the California Supreme Court delivered a significant win to product manufacturers concerning the admissibility of industry custom and practice evidence in a strict product liability design defect action. Haynes and Boone, LLP Partner M.C ...
On October 6, 2021, Governor Gavin Newsom signed Assembly Bill 45 (AB 45) into law. AB 45 permits the manufacture and sale of a wide range of products containing regulated amounts of industrial hemp. Below is a brief overview: What is industrial hemp? “Industrial hemp” is defined as cannabis plants that have no more than 0.3% tetrahydrocannabinol (THC) ...
July 21, 2022 By: John Epperson and Peter McGaw California has a long history of enacting laws regulating plastic packaging, dating back to the Rigid Plastic Packaging Container law in 1991, a law many manufacturers only learn about when they receive a notice from the California Department of Resources Recycling and Recovery (“CalRecycle”) ...
Law on the Management of Commercial Gambling, Royal Kram NS/RKM/1120/031 dated 14 November 2020 Overview On 14 November 2020, the Law on the Management of Commercial Gambling (“Gambling Law”), the first comprehensive legislation to regulate casinos and commercial gambling centers in Cambodia, was promulgated ...
In response to the impact of COVID-19 and the partial withdrawal of EBA benefits – see our update here – the Cambodian government have issued a number of regulations which are intended to provide some relief to affected businesses in Cambodia. We outline these updates below: Letter 1313 MEF – dated 25 February 2020 Notification no ...
On 21 November 2022, the Ministry of Industry, Science, Technology and Innovation (“MISTI”) issued Prakas 252 on the Implementation of General Principles of Food Hygiene in Factories, Enterprises and Handicrafts (“Prakas 252”) to establish standard requirements for food factories, enterprises and handicrafts in Cambodia ...
New Promulgated Law and Subsequent Regulations on Health, Administrative and Other Measures during Covid-19 Outbreak In response to the recent community outbreak of Covid-19 on 20 February 2021, the Royal Government of Cambodia (“RGC”) promulgated and issued a number of regulations, specifically: Law on Preventative Measures against the Spread of Covid-19 and other Highly Contagious Diseases dated 11 March 2021 (“Preventative Measures Law”); Sub-Decree 37 dated 12 Ma
With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced bans on exports of protective gear to avoid shortages at their countries. But is this in conformity with the principle of free movement of goods as provided for in articles 34-36 TFEU? This principle is one of the cornerstones of the European Union's internal market which implies that national barriers to the free movement of goods within the EU need to be removed ...
Introduction The Covid-19 vaccine is currently being rolled out, and according to the authorities’ vaccination-plan, a large part of the population will receive their first dose during the summer months. As a rule, one must take the vaccine in one’s own home municipality, and not in the municipality where one has a summer house etc. In addition, the authorities are working on a corona certificate ...
