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 ...
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) ...
On May 25, 2011, the en banc Federal Circuit announced its decision in Therasense, Inc. v. Becton, Dickinson & Company regarding the appropriate standards for succeeding with an inequitable conduct defense ...
On 10 March 2022, the Cabinet Office published the long-awaited draft Terms of Reference for the UK COVID-19 Inquiry.1 In this article we consider the implications for businesses impacted by the pandemic and how they may wish to get involved in the Terms’ finalisation. Terms of Reference are critical to a public inquiry as they define its scope and purpose ...
Beginning of Stage 2 of the National Vaccination Plan The Colombian Ministry of Health and Social Protection (Minsiterio de Salud y Protección Social) declared the initiation of stage 2 of the National Vaccination Plan against COVID-19 for the population between 60 and 79 years of age. This does not mean that vaccination for those over 80 years of age will be stopped; these people will continue to be vaccinated without any interruption ...
A dangerous trap for an unwary insured looking for insurance coverage can be a notice provision. To trigger certain liability insurance policies, the insurer may require that a “claim” be both made against an insured and that the insured then report such claim to its insurer during the time the single insurance policy is in effect. This is what is known as a “claims-made-and-reported” policy ...
By: John Epperson San Francisco’s Board of Supervisors passed an Emergency Ordinance on July 7 entitled “Cleaning and Disease Prevention Standards in Tourist Hotels and Large Commercial Office Buildings” (the “EO”). The EO is expected to be signed by the Mayor and go into effect soon ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
On June 7, 2021, the Department of Managed Health Care (“DMHC”) issued an All Plan Letter (APL-21-016) to the health care service plans it regulates, announcing that health care service plans must continue to cover certain COVID-19 testing for their enrollees beyond the now-expired DMHC’s emergency regulation[1] (“Emergency Regulation”) ...
San Francisco’s Department of Public Health (“SFDPH”) issued yet-another update to its Shelter-in-Place Order, C19-07, on September 14, 2020 (now up to version “i”). This order has been frequently modified to reflect changes in other state and local directives, as more is learned about the disease and as more businesses are allowed to re-open ...
U.S. Trademark laws are based on the premise that rights in a trademark exist so long as the mark is continuously used in interstate commerce. Once you cease use of the mark without an intention of resuming such use, the mark may be subject to cancellation or abandonment by a third party ...
September 16, 2021 By: John Epperson The COVID-19 pandemic will likely to be a concern and challenge for employers for longer than anyone had hoped or anticipated. As businesses adjust to what seems to be a “new normal” it is worth a reminder that COVID-19 infection can be a recordable illness on an employer’s Occupational Safety & Health Administration (“OSHA”) 300 Injury and Illness Log. OSHA’s recording criteria under 29 CFR 1904 ...
Cal-OSHA’s COVID-19 regulation remains in effect after the trial court rejected a motion for a preliminary injunction filed by a coalition of employers. This included challenges to: (1) compensation for employees excluded from work; (2) mandated testing; and (3) health and safety requirements for employer-provided housing and transportation. Therefore, employers must continue to abide by the requirements of the emergency regulation ...
As California continues to move through Stage 2 of its Resilience Roadmap, “Lower-risk workplaces,” where retail (curbside and delivery only), related logistics and manufacturing, office workplaces, limited personal services, outdoor museums, childcare, and essential businesses can now open with modifications, California employers should continue to be vigilant in assessing and complying with up to date health and safety guidance from the Occupational Safety and Health Admini
In addition to proceeds from the U.S. Small Business Administration’s (“SBA”) Payment Protection Program and the Centers for Medicare & Medicaid Services’ (“CMS”) Accelerated and Advance Payment Program, the U.S. Department of Health & Human Services (“HHS”) recently deposited $80 billion into health care providers’ bank accounts as part of its Provider Relief Fund ...
On Friday, March 27, 2020, the CARES ACT was signed into law. The Cares Act includes provisions for changing deadlines for patents, trademarks, and copyrights. For patents and trademarks, the Act permits the Under Secretary of Commerce for Intellectual Property and the Director of the United States Patent and Trademark Office to change the deadlines imposed by Title 35 of the United States Code, the Trademark Act, Section 18 of the Leahy-Smith America Invents Act ...
“With our nation’s health care providers on the front lines in the fight against COVID-19, dollars and cents shouldn’t be adding to their worries.” - CMS Administrator Seema Verma. During this Public Health Emergency, the Centers for Medicare & Medicaid Services (“CMS”) has expanded its accelerated and advanced payment program (“Program”) to all Medicare-enrolled providers and suppliers (“Providers”) ...
Key Points Governor Newsom vetoed AB 339. AB 361 will continue to operate as currently construed. On October 7, 2021, Governor Newsom vetoed Assembly Bill (AB) 339 (Lee), a bill aimed at addressing Brown Act teleconferencing requirements for large public entities. AB 339 sought to add special rules for meetings of city councils or county board of supervisors that govern jurisdictions containing at least 250,000 people ...
The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...
Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit transition period. The Brexit transitional period, during which EU laws and rights have continued in force in the UK, will end on December 31, 2020. Thereafter, EU Trade Mark and Design applications and registrations (and designations of the EU) will only cover the remaining 27 EU member states ...
This is the first in our series of articles in which we will look at how Brexit and the EU-UK trade deal impacts research and development. In July 2020, the Government published its Research and Development Roadmap, which sets out the UK’s ambitious long-term objectives for investment in science and research to deliver economic growth and societal benefits across the UK ...
On July 7, 2016, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intended to prohibit hospitals operating certain off-campus provider-based departments (PBDs) from billing under the Outpatient Prospective Payment System (OPPS). In an effort to implement Section 603 of the Bipartisan Budget Act of 2015, CMS says the proposed rule will save about $500 million a year by refocusing payments on the patient rather than the clinical setting ...
On the occasion of Breast Cancer Awareness Month 2022, our firm organized a photo-taking session on Friday, October 21 at 3 pm. This session is a part of a global effort to raise awareness about breast cancer, one of the world’s most prevalent types of cancer. Often times, the disease has been overlooked by males. However, breast cancer can affect both men and women ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
