On April 21, 2020, the Drug Enforcement Administration (DEA) published a Request for Information (“RFI”) that reopened the comment period for an interim final rule that was published March 31, 2010 (75 FR 16236) (the “2010 IFR” or the “IFR”). The IFR is being revisited in response to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) mandate for the DEA to update the requirements for the biometric component of multifactor authentication with respect to electronic prescriptions of controlled substances. Prior to the 2010 IFR, the only way that controlled substances could be prescribed was in writing, on paper with a wet signature. The IFR was the first time that an electronic alternative was made available for prescribing controlled substances and the DEA leveraged the technologies that were available at the time to ensure that electronic prescribing applications could not be misused to divert controlled substances.
Monthly Archives: April 2020
U.S. Supreme Court – Willfulness Is Not a Prerequisite for a Profit Award for Trademark Infringement
In its unanimous April 23, 2020 opinion in Romag Fasteners v. Fossil, Inc., the Supreme Court made clear once and for all that a successful trademark plaintiff is not required to establish that the defendant’s infringement was willful to be entitled to an award of the infringer’s profits. In other words, profits may be disgorged for less than willful infringement of a trademark.
The U.S. Supreme Court decision today in Maine Community Health Options v. United States, is a major decision affecting healthcare and resolving a significant Obamacare dispute. The Affordable Care Act famously established online exchanges where insurers could sell their healthcare plans. It included the now-expired “Risk Corridors” program aimed to limit the plans’ profits and losses during the exchanges’ first three years (2014-16). The Act contained a formula for computing a plan’s gains or losses at the end of each year, providing that eligible profitable plans “shall pay” the Secretary of the Department of Health and Human Services (HHS), while the Secretary “shall pay” eligible unprofitable plans. But the Act did not appropriate funds that the Secretary could dispense or cap the amounts that the Secretary would pay to unprofitable plans. Nor was there any budget neutrality stated in the Act. The program was something less than a great success and, after three years, in which unprofitable plans outnumbered those that were profitable, the net deficit was more than $12 billion. But the Centers for Medicare and Medicaid Services (CMS) couldn’t make any payments to unprofitable plans because, each year, its budget appropriation included a rider preventing CMS from using the funds for Risk Corridors payments. Four unprofitable plans brought suit against the government under the Tucker Act, alleging that the ACA obligated the government to pay the full amount of their negative deficit. With Justice Sotomayor writing for seven other Justices (Alito, J. dissented, and Thomas, J. and Gorsuch, J. did not join one section of the majority opinion), the Court agreed with the plans and reversed the Federal Circuit’s holding that while the ACA initially created an initial obligation, the subsequent riders vitiated it.
Starting from 1 July 2020 an experiment will be conducted in Moscow aimed at setting a legal framework for the development and implementation of AI technologies
Federal law No 123-FZ1 sets a legal framework in Moscow for the development and implementation of artificial intelligence (AI) technologies. The experimental legal framework is established for five years starting from 1 July 2020.
The law sets out goals, objectives, and main principles of establishing the experimental legal framework and regulates relations arising therein. The main objective of the experiment – examine how the AI technologies work, which sectors of the economy and social relations require its` implementation. After the experiment, decision on further amendments to the legislation will be made.
UPDATE: CMS reevaluates Accelerated Payment Program, suspends Advance Payment Program for Part B suppliers and points providers to relief fund
On April 26, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating pending and future amounts that it will pay under its Accelerated Payment Program and is suspending its Advance Payment Program for Part B suppliers, effective immediately. CMS noted it has already approved almost 24,000 applications resulting in $40.4 billion of payments for Part B suppliers, including doctors, non-physician practitioners and durable medical equipment suppliers.
On 1 January 2020, the Foreign Investment Law of the People’s Republic of China (“FIL“) came into force, at the same time, the four-decades old Sino-foreign Equity Joint Venture Law of the People’s Republic of China (“EJV Law“) and the three-decades-plus old Sino-foreign Co-operative Joint Venture Law of the People’ Republic of China (“CJV Law“) and their relevant regulations were simultaneously repealed. Read more…
On 1 January 2020, the Foreign Investment Law of the People’s Republic of China (“FIL“) came into force, and at the same time, the three-decades-old-plus Wholly Foreign-owned Enterprises Law of the People’s Republic of China (“WFOE Law” and its relevant regulations were simultaneously repealed. Read more…
As of April 27, more than 97% of the U.S. population is still under a stay-at-home order or shelter-in-place order in response to the rapid spread of COVID-19. McDonald Hopkins has an updated list with insight on where each state stands in the push to reopen.
On April 18, 2020, the President of the Russian Federation signed a decree1 “On temporary measures to regulate the legal status of foreign citizens and stateless persons in the Russian Federation in connection with the threat of the further spread of a new coronavirus infection (COVID-19)” (“Decree”). The measures provided for by the Decree are limited in their duration – from March 15 to June 15, 2020, inclusive. Below we will consider the main measures established by the Decree with respect to foreign citizens who came to Russia both on a visa-free and visa basis, as well as stateless persons (hereinafter jointly referred to as “foreign citizens” as well):