On May 17, 2021, the United States Health Resources and Services Administration (HRSA) publicly disclosed letters which were sent to six major pharmaceutical manufacturers. HRSA’s letters expressly state that each manufacturer is currently in violation of the Federal 340B Program statute as a result of policies restricting contract pharmacies and covered entities from access to 340B Program discounted medication ...
Welcome to the tenth issue of the 2021 edition of Unprecedented. The big news from the past two weeks was the Center for Disease Control’s announcement of new guidance allowing fully vaccinated individuals to go unmasked in nearly all circumstances. The announcement was unexpected and sent governments and businesses scrambling to respond. Some governments, like my home state of Pennsylvania, reacted the same day to conforming their own requirements to the new CDC guidance ...
Following Prime Minister Boris Johnson’s recent announcement in Parliament, it is now certain that there will be a Public Inquiry into the handling of the pandemic. What is the planned Inquiry likely to consider, and who might be involved? For over a year now, the government’s focus has been on the here and now - managing and responding to the rollercoaster that is the COVID-19 crisis ...
Trimble Inc. v. PerDiemCo LLC, Appeal No. 2019-2164 (Fed. Cir. May 12, 2021) In this week’s Case of the Week, the Federal Circuit revisited its decision in Red Wing Shoe Co. v. Hockerson-Halberstadt, Inc., 148 F.3d 1355 (Fed. Cir. 1998), often cited for the proposition that a patentee does not subject itself to personal jurisdiction in a forum merely by sending correspondence asserting patent infringement by a resident of the forum ...
For those of us in the dispute resolution world in construction, one cultural trait that is seen with nearly all contractors is a strong sense to do the job right. Most businesses are small, and closely held. And most contractors carry significant pride in their work product and in keeping their clients happy. That character extends not only to work in progress, but also to resolution of issues related to the work after it is complete ...
On Thursday, May 13, 2021, the Centers for Disease Control (CDC) announced new guidance stating it is safe for fully vaccinated people to not wear masks or physically distance in any non-health care setting.1 Per this guidance, fully vaccinated people can now resume most activities without wearing a mask or physically distancing ...
On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Interim Final Rule, CMS-3401-IFC related to Long-Term Care Facility Testing Requirements and the COVID-19 Focused Survey Tool. CMS published the initial interim final rule with comment period on Aug. 25, 2020 ...
On May 11, 2021, the Center for Medicare & Medicaid Services (CMS) announced a new rule that will require long-term care facilities and residential facilities serving clients with intellectual disabilities to educate and offer COVID-19 vaccines to residents, clients and staff. This new requirement will closely align with current requirements for influenza and pneumococcal vaccines in long-term care facilities ...
On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Nursing Home Visitation. CMS issued its initial guidance in March 2020, via memorandum QSO-20-14-NH. Under this memorandum, all visitation by visitors and non-essential health care personnel was restricted, except for situations involving compassionate care, such as end-of-life ...
The Court of Appeal has unanimously held that a tenant’s statutory declarations given to landlords were valid even though they did not specify the precise term commencement date of the leases to be contracted out. Landlords will be relieved that the Court of Appeal did not adopt an overly legalistic and commercially impractical interpretation of the contracting-out requirements ...
Stepmother's Day exists, although it is probably not widely celebrated. Most people are probably not aware that there is a Stepmother’s Day, which falls this year on 16 May 2021. It is marked one week after International Mother’s Day, which differs from our British version. Many families are unlikely to celebrate Stepmother’s Day and there may be good reason for that ...
The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing an investment in an ambulatory surgery center (ASC) made by a health system, certain physicians employed by the same health system, and a management company. OIG Advisory Opinion No. 21-02 is the first advisory opinion since 2009 to provide guidance on ASC investments and related safe harbors to the Anti-Kickback Statute ...
For Mental Health Awareness Week, Caroline Watson, head of Shoosmiths Family Law team, offers practical advice on looking after your emotional wellbeing if you’re going through a divorce or a separation. When someone close to you dies, it’s generally accepted that there are five stages of grief: shock, denial, anger, bargaining, depression and acceptance. Some psychiatrists say that the emotional stages of a relationship breakdown are the same ...
By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...
Factual background The taxpayer, Dr Leung, was a medical doctor employed by the Hospital Authority (“HA”). Part of the conditions of his employment was that he was required to be ‘on call’ on certain days including Sundays and public holidays. When ‘on call’, he was obligated, among other things, to be within the physical proximity of the hospital, to be ready to render medical services if the need arose, and to abstain from drinking alcohol ...
Cap Export, LLC v. Zinus, Inc., Appeal No. 2020-2087 (Fed. Cir. May 5, 2021) The Federal Circuit issued a single precedential patent case this week. The district court set aside a judgement and injunction originally in favor of Zinus and against Cap Export, pursuant to Rule 60(b)(3), in light of apparently fraudulent testimony offered by a critical witness. In a rare decision addressing Rule 60, the Federal Circuit affirmed ...
On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...
The Ohio Board of Pharmacy recently announced it will award up to an additional 73 dispensary licenses across Ohio. Dispensary licenses will be awarded through an application and lottery process that is expected to be finalized during the spring or summer of 2021. This expansion will bring the total number of dispensary licenses in Ohio to 130 and is expected to ameliorate patient dissatisfaction with regards to the price of medical marijuana products and lack of equal access ...
Dispute ResolutionThreshold to Commence Winding Up Proceedings RaisedBy the Federal Government Gazette Notification No. 4159 dated 22 March 2021, the amount of indebtedness required to commence winding up proceedings under section 466(1)(a) has been fixed at RM50,000.00 with effect from 1 April 2021.This means that a creditor may only commence winding-up proceedings against a debtor company where the debtor company has failed to satisfy a debt owed to the creditor exceeding RM50,000 ...
For some years, contractors and subcontractors have been using an effective tactic in adjudication. That is to pick off discrete elements of a large time or money claim and to obtain a series of favourable declarations in adjudications on those elements. The declarations can then be used as a bargaining tool to leverage a settlement of the full claim. Or they can be converted into payment orders by way of a further adjudication ...
The impact of the pandemic can be seen across all sectors of society but those who are disabled have been particularly affected, not least because employees with an underlying disability are likely to have been identified as clinically extremely vulnerable and told to shield for considerable parts of the last year. Being away from the workplace and separated from colleagues has left many feeling insecure ...
On April 26, 2021, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on its OCR Security List Digest that OCR had been made aware of misleading postcards being sent to health care organizations. The postcards inform recipients that they must participate in a “Required Security Risk Assessment.,” It directs them to send their risk assessment to www.hsaudit.org, a non-governmental website marketing consulting service ...
The Department of Justice (DOJ) suffered an unusual defeat when its motion for late intervention in a False Claims Act (FCA)[1] qui tam case, United States ex rel. Odom v. Southeast Eye Specialists, PLLC,[2] was rebuffed by the Middle District of Tennessee, rejecting the magistrate judge’s recommendations ...
