With many medical practices and healthcare practitioners moving to telemedicine during the COVID-19 pandemic, questions abound on legal requirements, privacy, and the future of healthcare. Schwabe’s Healthcare team has taken a closer look at the legal issues surrounding the rise of telemedicine during the pandemic and the implications for our healthcare future in the four articles below ...
Introduction If 2020 has been defined by COVID-19 pandemic, the healthcare industry in 2020 might be defined by a related single issue — telehealth. Those phenomena are obviously connected. While telehealth has been around in varying forms for years, COVID-19 accelerated its growth, use, and acceptance in unprecedented ways. With that growth comes changes. Reimbursement rules have evolved as telehealth has grown and become more accepted ...
Introduction If 2020 has been defined by COVID-19 pandemic, the healthcare industry in 2020 might be defined by a related single issue — telehealth. Those phenomena are obviously connected. While telehealth has been around in varying forms for years, COVID-19 accelerated its growth, use, and acceptance in unprecedented ways. With that growth comes changes. Reimbursement rules have evolved as telehealth has grown and become more accepted ...
Law360 published an article this week by Dinsmore health care attorney LaTawnda Moore about an ongoing scheme made possible by the increasing prevalence of telehealth during the COVID-19 pandemic. This scheme is putting telehealth executives and health care providers at risk of criminal and civil liability. An excerpt is below. The telehealth executives pay health care providers for prescriptions ...
In 2020, telehealth went from promising ancillary issue to center stage in the healthcare industry. Regulators and law enforcement took notice. With enforcers’ attention now squarely on telehealth fraud and abuse, telehealth providers and companies are poised to be among the main targets for civil and criminal enforcement in the coming years. Webinar Recording Key Takeaways Telehealth is a key enforcement priority for federal and state enforcement agencies, including the U ...
March 24, 2022 By: Andrea Musker The Consolidated Appropriations Act of 2022, signed by President Biden on March 15, 2022, extends federal telehealth flexibilities beyond the expiration date of the public health emergency for a limited time. The public health emergency is currently set to expire on April 16, 2022, but it may be renewed for another ninety days ...
This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE ...
The Internal Revenue Service has proposed guidelines detailing how tax-exempt hospitals can conduct a Community Health Needs Assessment (CHNA), as required in the 2010 Patient Protection and Affordable Care Act (PPACA). Although this new requirement is not effective until taxable years commencing after March 23, 2012, the IRS issued its guidance now because hospitals may choose to start the process of conducting CHNAs and implement strategies in advance of the effective date ...
The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...
Introduction Advocate General Jacobs, in delivering his Opinion in Syfait and others v Glaxosmithkline (Case C-53/03, 28 October 2004), has found in favour of Glaxosmithkline (GSK) by stating that the refusal by a dominant pharmaceutical company to fulfil all orders from wholesalers does not automatically constitute an abuse of a dominant position, despite such refusal clearly limiting parallel trade of the products in question ...
The Philippine Government has issued a slew of resolutions and circulars as part of its response to the COVID 19 pandemic and unsurprisingly, a number of legal and practical issues have beset businesses and persons under the Luzon-wide enhanced community quarantine (ECQ)1. Like the rest of the world, the country is bracing itself for a new normal – in the way enterprises are run, services are rendered, everyday tasks are undertaken ...
Covid-19 is upending capitalism as we know it. Amid the pandemic, how can businesses rewrite their rule books so as to emerge stronger? Americans have allegedly outbid the French for masks “right on the tarmac” just as the goods were to be flown off to their destination. From Amazon to Rakuten to Carousell, traders exploited fears by price-gouging on masks and hand sanitisers ...
More recently, many more people are using fertility treatment to conceive; particularly same sex couples, single women and surrogates (Human Fertilisation and Embryology Authority data). This echoes a societal shift in so far as relationships, the formation of families and lifestyles are concerned. As such, there needs to be more emphasis on the development and evolution of the law and sector generally ...
On May 16, 2022, the Colorado Supreme Court issued an opinion that serves as a cautionary tale for health care providers hoping to bill patients at chargemaster rates. The court’s decision in French v. Centura Health turned on the meaning of the phrase “all charges of the Hospital,” as set forth in the hospital service agreement (HSA) signed by Ms. French. Centura argued that the phrase “unambiguously refers to a hospital’s chargemaster rates.” Ms ...
Hidden among its flurry of end-of-term blockbusters, on June 27, 2022, the U.S. Supreme Court issued a long-awaited opinion inRuan v. United States. InRuan,the Supreme Court addressed the issue of whatmens reaa physician must possess to be guilty of illegally distributing controlled substances through the use of allegedly improper prescriptions ...
The Supreme Court has unanimously upheld an arbitrator’s ruling that a contract that required arbitration of "any dispute" constituted an agreement to class-wide arbitration. The Court’s narrow ruling turns on the parties’ express agreement to allow the arbitrator to decide whether their contract, which contained an arbitration provision but did not mention class proceedings, authorized class arbitration ...
A month after nixing the “objectively reasonable interpretation” (Safeco) defense under the False Claims Act, the Supreme Court has vacated and remanded two other cases for further consideration of the defendant’s subjective state of mind when it filed payment claims with the government. The Fourth Circuit in Sheldon and the Eleventh Circuit in Olhausen will provide the first tests of the High Court’s newly minted FCA intent standard ...
In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...
In a unanimous decision today, the Supreme Court rejected efforts to limit access to the abortion pill mifepristone, overturning an earlier decision by the 5th Circuit Court of Appeals. The Supreme Court ruled that the physicians and medical associations who brought the case did not have the right to challenge the FDA's regulation of the drug. To have standing, plaintiffs must show they have a “personal stake” in the case ...
The FDA’s Proposals on the Revision of the Nutrition and Supplement Facts Labels In early 2014, first lady Michelle Obama announced upcoming changes to the FDA’s Nutrition Facts label, and in March 2014, the FDA issued a proposed rule on the revision of Nutrition and Supplement Facts labels “to assist consumers in maintaining healthy dietary practices ...
This week marks National Fertility Awareness Week in the UK. This annual event, organised by Fertility Network UK, a national charity dedicated to supporting individuals on their fertility journeys, aims to change perceptions and raise awareness for those undergoing fertility treatment. The theme for this year is "Forward4Fertility," emphasising progress and inclusivity in the journey towards parenthood. The staggering fact that over 3 ...
In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...
Summary On September 9, 2021, President Biden issued his Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors (the “Executive Order”) that, when implemented, will require most federal contractors to comply with all guidance for federal contractor and subcontractor workplace locations published by the Safer Federal Workforce Task Force (see www.saferfederalworkforce.gov) ...
In the early hours of Saturday, March 14, 2020, the United States House of Representatives passed the Families First Coronavirus Response Act (FFCRA), which is designed to expand relief in response to the COVID-19 outbreak, through access to free testing, enhancing food assistance, increasing Medicaid funding, and providing paid sick leave and unemployment benefits to workers ...
