As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
Courts nationwide have struggled for years with the question of when a subjective opinion is false under the False Claims Act. The Supreme Court’s decision to deny review of two cases involving health-care providers that had allegedly submitted false claims for payment based on subjective clinical judgment still leaves us without a uniform, national answer, says Nicholas A. Danella. The U.S ...
In one of the latest and most high-profile decisions from across the country relating to commercial tenants’ rent obligations during the COVID-19 pandemic, the United States District Court for the Southern District of New York rejected an attempt by The Gap, Inc. (“Gap”) to excuse payment of such obligations due to the pandemic and related government restrictions ...
The legal and practical issues that arise when executing documents electronically with a focus on practical points to consider and pitfalls to avoid. This is quite a hot topic at the moment with businesses having to continue to operate during lockdown ...
On March 9, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced a 45-day extension of the public-comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on Dec. 10, 2020, and it was published in the Federal Register on Jan. 21, 2021 ...
On March 10, 2021, the Centers for Medicare & Medicaid Services (CMS), in association with the Centers for Disease Control and Prevention (CDC), issued updated guidance for nursing homes to resume visitation options during the COVID-19 pandemic. Nursing homes have been devastatingly effected by COVID-19, with outbreaks causing high rates of infection and death ...
In recent months, the need to conclude the procedures to adapt/amend/revise the municipal and inter‑municipal plans for spatial planning has been widely discussed by the municipalities, the Government, economic agents and civil society. This discussion has focused on: i) The integration into in those plans of the rules contained in special plans concerning the arrangements to safeguard territorial resources and natural values that directly bind private individuals ...
In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021 ...
For those of us in the HUD-insured multifamily finance space who make our living trying to shrink the time period between firm commitment and closing, Chapter 19 of the new Multifamily Accelerated Processing (MAP) Guide was a must-read when it was published at the end of 2020 ...
Title reviews are the heartbeat of the due diligence process. When a buyer is considering acquiring a commercial property, it is the title review process that confirms the seller actually owns the property and provides an overview of all rights affecting such property ...
On March 4, 2021, Exempt Resolution No. 625 of the Ministry of Mining (“Res. No. 625”) was published in the Official Gazette. Res. No. 265 sets forth a citizen consultation process on the proposal to amend Supreme Decree No. 248 of 2007, which approved the Regulations on the Approval of Projects of Design, Construction, Operation and Closure of Tailings Dams (the “Regulations”) ...
In September 2020, a team of MIT researchers published a paper in the IEEE Open Journal of Engineering in Medicine and Biology, testing the hypothesis that coronavirus carriers—even asymptomatic ones—could be accurately detected using artificial intelligence (AI) based on only a phone recording of a forced cough.If this hypothesis is correct, the COVID-19 test can be accessible to people worldwide ...
CRIMINAL Counterfeit VaccinesBy Andre Augusto Mendes Machado and Mariana Murad Leiva Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes" ...
On Thursday, February 25, 2021, a Federal Court Judge in the Eastern District of Texas sided with a group of landlords by holding that the eviction moratorium instituted by the Centers for Disease Control and Prevention (CDC) is unconstitutional by extending “far beyond the legitimate scope of federal power ...
From 1 April 2021, a 2% Stamp Duty Land Tax (SDLT) surcharge will apply to non-UK residents purchasing residential property in England & Northern Ireland. However, what is meant by a non-UK resident in these circumstances can result in some surprising outcomes ...
The period for filing complaints to challenge 2020 property tax values in Ohio ends on March 31, 2021. For properties assessed in a 2020 county reappraisal or update, a reduction in the 2020 value may offer greater tax savings now than at any point for the next three tax years. However, the potential impact of COVID-19 on tax year 2021 values must be carefully considered ...
By Michael Flynn, Doug Prince and Khaled Tarazi Buchalter’s February 16 COVID Alert (https://www.buchalter.com/wp-content/uploads/2021/02/FHA-VA-USDA-Foreclosure-and-Eviction-Moratoria-and-Forbearance-Application-Deadline-Extended-to-June-30.pdf) reported that the federal government had extended the FHA, VA and USDA timelines for single-family foreclosure and eviction moratoria and forbearance periods to June 30, 2021 ...
By Michael Flynn, Doug Prince and Khaled Tarazi On Thursday, February 25, a Federal judge in the Eastern District of Texas ruled that the CDC tenant eviction order is unconstitutional, but did not enjoin the order. The case was brought by seven Texas landlords against the CDC, challenging the CDC moratorium order. The CDC moratorium applies to tenants who, among other things, declare economic hardship and earned $99,000 or less in 2020 ($198,000 for couples) ...
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 ...
It’s been more than a year since the COVID-19 pandemic began, and many companies are attempting to market products intended to help consumers deal with the risks associated with COVID-19. Some of the most common examples of such products include face masks, testing devices, hand sanitizers, and hard-surface disinfectants ...
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 ...
This article has been updated based on the available information until 20th February 2021. As Government notifications are constantly revised, it is advisable to consult your attorney or visit the website of the relevant Government agency prior to travelling. Further, in additional to the guidelines published by the Central Government, passengers are also requested to refer to State specific official websites to be well informed about any additional requirements ...
As you already know, COVID-19 changed almost everything, and some of those things are likely here to stay (or at least linger for a while longer). One widespread change is the increased use of videoconferencing. In early 2020, a videoconference was a rarity, but now we Zoom in and out of classrooms, work meetings, and court appearances. Not surprisingly, the virtual world has reached the doctor’s office ...
As we near the second year of the COVID-19 pandemic, trademark maintenance deadlines in 2021 create new obstacles for registrants. To maintain a federal trademark registration, registrants must periodically file an affidavit of use under Section 8, swearing that the mark is in use in commerce or that the registrant has an acceptable excuse for nonuse. Recent office actions show that the U.S ...
In its conference on Feb. 19, the U.S. Supreme Court is scheduled to consider two pending petitions for certiorari that could resolve a critical but deeply disputed issue that impacts both the False Claims Act and health care law. The cert petitions in those cases — U.S. v. Care Alternatives,[1] and Winter v ...