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Practice Industry: Healthcare & Pharmaceuticals, Life Sciences

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Natural Products and Pharmaceutical Innovations: What are the Patent Options?
Lavery Lawyers, May 2020

Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them...

Do You Have a Cough? What Can I Ask Customers and How Do I Protect Their Privacy?
Lawson Lundell LLP, May 2020

As businesses begin to reopen, many organizations will examine ways to protect their workers and attract returning customers. Various mechanisms to screen customers for COVID-19 risks will become more common. Examples include providing customers with questionnaires regarding their travel history, exposure to others, and symptoms, or temperature scanning before entry. Organizations will be permitted to screen individuals in a reasonable manner, depending on the circumstances...

Weekly Report: COVID-19 in Central America (May 16 - 22)
Consortium Legal - El Salvador, May 2020

Special Report "COVID-19 in Central America" on special measures taken in each country of our region prepared by the multidisciplinary team of Consortium Legal. The information contained in this publication is for information purposes only and does not constitute legal advice. The information is constantly updated and is subject to change...

Insurance Recovery During the COVID-19 Pandemic: Navigating Your Policy’s Microbe and Pollution Exclusions
Haynes and Boone, LLP, May 2020

As corporate policyholders continue to submit claims to their insurers for business interruption and related losses sustained from the COVID-19 pandemic, insurers appear to be denying such claims routinely where the policies at issue contain exclusionary language specific to viruses — whether in stand-alone virus exclusions or other types of exclusions...

Modification of Decree Nº 466, of 1984, of the Ministry of Health, Which Approves the Regulation in the Matter of Electronic Commerce of Medicines
Carey, May 2020

On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means...

Pharmaceutical Industry: It is Time to Check the Structure of Doing Business in Russia
ALRUD Law Firm, May 2020

In the context of COVID-19 pandemic, the field (on-site) tax audits in Russia are currently postponed, but once all restrictions are lifted, the tax authorities can start auditing Russian companies and replenishing the National Budget by redoubling their efforts. The pharmaceutical industry could be in the focus of the tax authorities and, above all, they could start with auditing of the contractual structures used for organizing clinical trials and promotion of pharmaceutical products...

Unprecedented: COVID-19 Litigation Trends, Issue 8
Spilman Thomas & Battle, PLLC, May 2020

This eighth edition of Unprecedented, our weekly update on COVID-19-related litigation, follows what we hope was a restful and meaningful Memorial Day weekend. For the third week in a row, shutdown challenges, workers' compensation claims, and wrongful death lawsuits have dominated the news cycle. But, we are also seeing a continuation in refund claims and an uptick in fraud claims involving everything from alleged misuse of sick days to corporate press releases...

COVID-19: Three Key Things in Health Care
Hunton Andrews Kurth LLP, May 2020

Three Key Things in Health Care offers snapshots of three significant issues in health care that we believe merit your attention. Published weekly by the Hunton Andrews Kurth Health Care Practice Group, the goal of Three Key Things is not to repeat what is already in the trade press, but to provide actionable ideas that will benefit your organization. We welcome your feedback! The COVID-19 crisis will be a driver for provider affiliation transactions...

“Opening Up”: Don’t Forget About Resident Rights as you Reopen
Spilman Thomas & Battle, PLLC, May 2020

The curve has flattened, and all fifty states are at least partially reopened. This raises a number of questions about how your facility should proceed with reopening while continuing to protect not only your residents' health, but also their rights. Both failing to meet recommended guidelines and exceeding the guidelines can leave your facility vulnerable for future governmental action and lawsuits...

Revised Measures in Response to COVID-19: Sterilisation and Opening Timings and an Updated List of Violations and Fines
Afridi & Angell, May 2020

On 18 May 2020, the UAE government announced the following timings with effect from today, 20 May 2020: the National Disinfection Programme will take place between 08:00pm (not 10:00pm) to 06:00am the following day. working hours of butchers, mills and cafes will be from 06:00am to 08:00pm. commercial centres and malls will be open from 09:00am to 07:00pm (with new opening hours to be announced after the upcoming Eid...

COVID-19 Quick Reference Regulatory Guide for Healthcare Providers
Haynes and Boone, LLP, May 2020

As healthcare providers respond to increased demands on supplies and resources due to the COVID-19 pandemic, regulators have issued certain flexibilities and guidance in responding to the public health emergency. The following guide and frequently asked questions are designed to address some of the more common issues and questions that providers face. As always, legal advice is fact-sensitive...

Three Tips for Healthcare Providers in Recovering Business Interruption Loss from the Public Health Crisis
Haynes and Boone, LLP, May 2020

Much of the media coverage of the COVID-19 pandemic over the last two months has focused on the loss of business sustained by restaurants, hotels and retail. Little attention has been paid to healthcare providers—at least those who are not valiantly staffing emergency rooms and intensive care units treating those patients stricken by the coronavirus...

COVID-19 Legal Briefing: Focus on Employment and Public Health Standards
SyCip Salazar Hernandez & Gatmaitan, May 2020

This briefing takes a deeper dive into the labor and employment aspect of COVID-19 issuances. Some of the guidelines here are covered in our The Return-to-Work-Checklist for Philippine Companies. A.  Operating establishments have been directed to comply with public health standards prescribed by the Department of Health (DOH), Department of Trade and Industry (DTI) and the Department of Labor and Employment (DOLE) 1.  The DTI issued DTI Memorandum Circular No...

CDPH Requires all California Skilled Nursing Facilities to Submit "COVID-19 Mitigation Plan" Creating New Documentation Concerns
Hanson Bridgett LLP, May 2020

On May 11, 2020, the California Department of Public Health ("CDPH") issued an All Facilities Letter (AFL 20-52) requiring skilled nursing facilities ("SNF") to develop and implement a facility specific COVID-19 mitigation plan (the "Plan") with six different, complicated elements. The CDPH requirement is in addition to any local requirements for COVID-19 planning and may or may not track the requirements already in place in some local jurisdictions...

Enforcement in the COVID-19 Era: The Government’s Likely Playbook
Bradley Arant Boult Cummings LLP, May 2020

With much fanfare, the Department of Justice (DOJ) has rolled out a series of headlines detailing its enforcement efforts in the wake of COVID-19. At the end of March, the government announced a kickback case against a marketer who allegedly steered patients towards COVID-19 and genetic cancer testing...

Mandatory COVID-19 Testing: Is Your Skilled Nursing Facility Prepared?
Spilman Thomas & Battle, PLLC, May 2020

As the COVID-19 pandemic continues, many states now are requiring mandatory testing of residents and employees of skilled nursing and assisted living facilities, including West Virginia, South Carolina, and Florida. Other states, such as Pennsylvania, are proposing legislation requiring mandatory testing. President Trump also has indicated that the federal government may require mandatory testing of all nursing home residents and employees nationwide...

Immigration Alert: USCIS Announces Temporary Policy Changes for J-1 Waiver Physicians during the COVID-19 National Emergency
Waller, May 2020

In light of the COVID-19 National Health Emergency, U.S. Citizenship and Immigration Services (USCIS) introduced temporary policies related to H-1B-sponsored physicians who are completing their three-year J-1 waiver service commitment requirements. The temporary policies relate to full-time work requirements and the ability of J-1 waiver-approved physicians to provide telehealth services...

CDPH Requires all California Skilled Nursing Facilities to Submit 'COVID-19 Mitigation Plan' Creating New Documentation Concerns
Hanson Bridgett LLP, May 2020

Key Points: New CDPH mandate requires action by skilled nursing facilities within 21 calendar days of issuance of All Facilities Letter. CDPH to conduct onsite visits to skilled nursing facilities every 6 to 8 weeks to verify compliance with facility's approved COVID-19 Mitigation Plan. New Mitigation Plan requirement is in addition to any local requirements for COVID-19 planning...

IRS Issues Cafeteria Plan Relief to Address COVID-19 Pandemic
Hanson Bridgett LLP, May 2020

Key Points Cafeteria plans may permit mid-year election changes prospectively, including health and dependent care FSA contributions, to address effects of COVID-19 pandemic. Grace period for health and dependent care FSAs may be extended through 2020, even for plans that allow carryovers. Employers must notify eligible employees of temporary plan changes, and adopt plan amendments by the end of 2021...

CMS-Mandated COVID-19 Reporting Requirements and Enforcement Actions Coming for Skilled Nursing
Hanson Bridgett LLP, May 2020

Key Points Facilities will have until the week ending June 7, 2020 to report specific COVID-19 data to the CDC or face the assessment of deficiencies and CMPs. Facilities are now required to notify residents, their representatives, and families when the facility has a confirmed COVID-19 infection or 3 instances of new onset respiratory symptoms within 72 hours...

Tips For Applying COVID-19 Stark Law Waivers
Bradley Arant Boult Cummings LLP, May 2020

Among the many extraordinary measures taken by the federal government in response to the COVID-19 pandemic is the issuance of blanket waivers of certain provisions of the federal self-referral prohibition commonly known as the Stark Law. The waivers loosen significant restrictions on physician financial relationships in an effort to provide health care providers with greater flexibility to meet the challenges of the pandemic...

Buchalter Client Alert COVID-19: Did you Receive a Deposit from HHS? Before you Spend it, Read This
Buchalter, May 2020

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...

Tips For Applying COVID - 19 Stark Law Waivers
Bradley Arant Boult Cummings LLP, May 2020

Among the many extraordinary measures taken by the federal government in response to the COVID-19 pandemic is the issuance of blanket waivers of certain provisions of the federal self-referral prohibition commonly known as the Stark Law. The waivers loosen significant restrictions on physician financial relationships in an effort to provide health care providers with greater flexibility to meet the challenges of the pandemic...

COVID-19: Employment Law in Japan - Some Key Questions
Atsumi & Sakai, May 2020

The sudden onset of the Covid-19 emergency has caused significant disruption across swathes of the Japanese economy and raised novel and urgent questions for employers as they seek to handle the challenges they face, whilst balancing the protection of their business and their obligations to their workers. This memorandum briefly addresses a number of key employment law issues and questions...

Time for a Check-Up: Are Your Arbitration Agreements and Admissions Procedures Up to Date for Your Skilled Nursing Facilities?
Spilman Thomas & Battle, PLLC, May 2020

During this turbulent period, now is the time to evaluate your facility's admission procedures and paperwork, especially your arbitration agreement. You want to make sure that in the event of litigation they will withstand strict scrutiny by the court. Failure to do so may have dire consequences that will leave your facility vulnerable.   If your admission procedures and paperwork are not sufficiently robust, a court will not enforce your facility's arbitration agreement...

 

 

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