King & Spalding (JD Supra United States)

4890 results for King & Spalding (JD Supra United States)

  • Update on the Proposed TRIPS Waiver at the WTO: Where is it Headed, and What to Expect?

    On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving intellectual property protections for COVID-19 vaccines” under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). A TRIPS waiver, if issued,...

  • Clinical Laboratory Agrees to Settlement with HHS for Potential HIPAA Security Rule Violations Despite Not Being Involved in Data Breach

    On May 25, 2021, HHS announced that Peachstate Health Management, LLC, doing business as AEON Clinical Laboratories (Peachstate), agreed to a $25,000 settlement and adoption of a comprehensive Corrective Action Plan for potential violations of the HIPAA Security Rule. Peachstate is a CLIA-certified laboratory that provides diagnostic and laboratory tests, including clinical and genetic testing...

  • Home Health Agency Unable to Block HHS From Recouping $2.8 Million in Alleged Overpayments

    An Arizona District Court judge held last week that the court lacked subject-matter jurisdiction over a home health agency’s (HHA) procedural due process claim because the HHA had failed to present its claim to HHS first and had not exhausted its administrative remedies before seeking judicial review. The court granted the HHS Secretary’s motion to dismiss and denied the HHA’s motion for...

  • District of New Jersey Jettisons Third Circuit’s Causation Requirement for Personal Jurisdiction in Wake of Supreme Court’s Ford Decision and Finds that BMW’s German Parent May Be Subject to Personal Jurisdiction in New Jersey

    On May 11, 2021, Judge Kevin McNulty of the District of New Jersey issued an order applying the Supreme Court’s recent personal jurisdiction decision in Ford Motor Co. v. Montana Eighth Judicial District Court, 141 S. Ct. 1017 (2021), and denied a motion to dismiss for lack of personal jurisdiction filed by BMW AG, the German parent company of BMW North America, in its “clean diesel” litigation.

  • The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps

    Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P manufacturers without an FDA-approved marketing application may find themselves subject to FDA scrutiny under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the...

  • Executive Order on Increasing the Minimum Wage for Federal Contractors

    On April 27, 2021, President Biden issued an Executive Order under his authority as President and through the Federal Property and Administrative Services Act, 40 U.S.C. 101 et seq., increasing the minimum wage paid to workers employed for federal government contracts and subcontracts...

  • Tenth Circuit Holds that “Heightened Scrutiny” Applies to Class Action Settlement Agreements That Include “Kicker” and “Clear Sailing” Provisions

    On May 7, 2021, the Tenth Circuit affirmed a district court’s approval of a class action settlement that contained “kicker” and “clear sailing” agreements—two frequently contested provisions related to attorneys’ fees—but held, for the first time, that such provisions are subject to heightened scrutiny. The opinion serves as a useful guide to class action litigants concerning the types of...

  • OIG Provides Additional Guidance Regarding Application of Administrative Enforcement Authorities to Arrangements Directly Connected to the COVID-19 PHE

    On May 24, 2021, OIG provided additional guidance in the form of an FAQ as to whether an offer or provision of cash, cash-equivalent, or in-kind incentives or rewards to Federal health care program beneficiaries who receive COVID-19 vaccinations during the PHE violate OIG’s administrative enforcement authorities (the May 2021 FAQ Guidance). OIG typically expresses concerns regarding the...

  • Second Circuit Finds Risk of Future Identity Theft Insufficient to Confer Article III Standing in a Data Security Class Action

    On April 26, 2021, the Second Circuit considered—for the first time in a published decision—the question of Article III standing in the context of a data security case. In McMorris v. Carlos Lopez & Associates LLC, the court joined a chorus of others in finding that plaintiffs’ allegations of an increased risk of future identity theft, without more, were insufficient to support Article III...

  • OIG Releases Semiannual Report to Congress

    On May 28, 2021, OIG released its Semiannual Report to Congress (the Report). The Report describes OIG’s work during the 6-month semiannual reporting period of October 1, 2020, through March 31, 2021 (the Semiannual Reporting Period). Principal Deputy Inspector General Christi Grimm highlighted that OIG is “aggressively investigating pandemic-related fraud that harms individuals and jeopardizes...

  • OIG Issues Favorable Advisory Opinions Regarding Medigap Plan and Preferred Hospital Organization Arrangements

    Last week, OIG posted Advisory Opinions Nos. 21-03, 21-04, and 21-05 relating to three near-identical arrangements between Medigap plans and Preferred Hospital Organizations (PHOs). The arrangements involve (i) a discount on a policyholder’s Medicare Part A deductible, (ii) a policyholder premium credit, and (iii) a monthly administrative fee to the PHOs. The arrangements are designed to...

  • COVID-19 and The Implications for Diversity, Equality and Inclusion

    COVID-19 has had a profound impact across all workplaces and sectors, with a rise in unemployment, economic inactivity and redundancies. Several global studies have shown that women have been disproportionately impacted by the pandemic as they are more likely to work in the “shutdown sectors” and/or perform roles more susceptible to furlough or redundancy (for example, roles which cannot be...

  • Federal Court Invalidates Medicare DGME Rule that Penalizes Hospitals for Training Fellows

    On Monday, May 17, 2021, Judge Timothy Kelly of the United States District Court for the District of Columbia issued a decision setting aside a regulatory formula CMS has adopted to compute Medicare DGME payments to hospitals. Milton S. Hershey Medical Center, et al., v. Becerra, No. 19-02680 (D.D.C. 2021)...

  • Q1 2021: Latin American Enforcement Review

    Enforcement authorities throughout the Americas continued investigations of fraud, corruption, and other misconduct across the region. Below are some of the highlights of the last quarter.

  • Regulation S-X Updates and the Pro Forma EBITDA Add-back

    On May 21, 2020, the Securities and Exchange Commission (the “SEC”) adopted amendments to the financial disclosure requirements in Regulation S-X (the SEC’s accounting rules for the form and content of financial statements included in SEC filings related to pro forma reporting for acquisitions and dispositions). The amendments were intended to streamline certain reporting requirements and...

  • Energy Newsletter - May 2021

    Business and Human Rights: Energy and extractives in a changing landscape of new generation trade agreements protecting and promoting both trade and human rights - As allegations of genocide, forced labour, or widespread abuse of minorities in various countries fill the airspace daily, consumers, shareholders, and governments are increasingly paying heed to business practices abroad. In the...

  • FinCEN’s New Whistleblower Program: Global Implications

    Modernizing FinCEN’s Whistleblower Program Under the Anti-Money Laundering Act of 2020 - INTRODUCTION - Reporting on multiple international money-laundering schemes last year brought public focus to the anti-money laundering (“AML”) enforcement efforts of the Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”). Capitalizing on the public attention, Congress...

  • Cyberattack and Ransomware Attack Force Majeure Considerations

    As criminal cyberattacks and ransomware attacks on critical infrastructure increase, companies may experience significant business disruptions. Ransomware and cyberattacks may prevent companies from fulfilling contractual requirements for the supply of product. Such attacks may also force companies to make difficult decisions regarding how to allocate a limited supply of product when...

  • The Potential of Wave Power

    Wave power is a type of hydroelectric power that relies on the capture of energy held by ocean waves. Like wind and solar power, wave power has the potential to be a valuable part of the energy transition. The potential of wave power lies in the immense amount of kinetic energy at stake. Wave power has far greater energy density than wind or solar. It generates up to 24-70 kW per meter of...

  • CMS Issues New Rule Imposing Education About, and Access to, COVID-19 Vaccines and Reporting Requirements for Nursing Home and Congregate Care Facilities

    On May 11, 2021, CMS issued an interim final rule requiring that nursing homes and other congregate care facilities: (1) educate all residents and staff about COVID-19 vaccines; (2) offer COVID-19 vaccines to all residents and staff when available; and (3) report the COVID-19 vaccination status of residents and staff to the CDC on a weekly basis (the Interim Final Rule). These requirements apply...

  • The Anti-Money Laundering Act and Crypto Collide: Non-Fungible Tokens

    As NFTs gain popularity, buyers and sellers should consider the potential issues related to federal anti-money laundering laws. While non-fungible tokens (“NFTs”) have existed for several years, the market for NFTs grew considerably during 2020 and into 2021, as a number of high-profile NFT sales grabbed headlines and well-known brands and organizations began exploring the use of NFTs. Amid...

  • National Contact Points in OECD Countries Promote Business & Human Rights in the Extractives Sector

    For over 20 years, a little-known dispute resolution mechanism has facilitated conciliatory ends to numerous human rights and environmental grievances levied against multinational corporations. The OECD’s National Contact Point (“NCP”) program empowers countries that adhere to the OECD’s Guidelines for Multinational Enterprises (the “OECD Guidelines”) to develop mechanisms to resolve complaints...

  • President Biden's Executive Order to Improve Cybersecurity Issued

    On May 12, 2021, President Joe Biden issued a wide ranging Executive Order “On Improving the Nation’s Cybersecurity,” which was in the works after the SolarWinds cyberattack and arrived soon after a ransomware attack on the Colonial Pipeline Company that cut off fuel supply to most of the east coast of the United States. The Order places responsibility on both the Departments of Defense and...

  • HHS Launches New Reimbursement Program for COVID-19 Vaccine Administration Fees Not Covered by Insurance

    On May 3, 2021, HHS announced a new program to cover the costs of COVID-19 vaccination for patients enrolled in health plans that either do not cover vaccinations generally, or cover them but with patient cost-sharing requirements. The new program, called the COVID-19 Coverage Assistance Fund, is designed specifically to address the gap for patients with health coverage but who may be hesitant...

  • OIG Updates COVID-19 Administrative Enforcement FAQs With Question Regarding Ambulance Providers’ Waiver or Discount of Certain Cost-Sharing Obligations for Medicare Beneficiaries

    On May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk of fraud and abuse where the ambulance provider or supplier waives or discounts costs of services paid for by Medicare under a waiver established pursuant to section 1135(b)(9

  • Ransomware on the Rise in Critical Infrastructure Sector

    Recent ransomware attacks against U.S. critical infrastructure, which includes the energy sector’s production of oil and natural gas, and other sources of electricity and power, have shed a spotlight on the importance of staying updated on sector-specific techniques, tactics and procedures (“TTPs”), and preventative and remediation actions. This Client Alert will: (1) provide a brief...

  • Not in My Court: Northern District of Texas Bankruptcy Court Dismisses NRA Bankruptcy Cases as Filed in Bad Faith

    On May 11, 2021, Judge Harlin D. Hale, of the Bankruptcy Court for the Northern District of Texas (the “Court”) found that the bankruptcy cases of the National Rifle Association of America (“NRA”) and its subsidiary Sea Girt LLC (collectively, the “Debtors”) were filed in bad faith to (i) gain an unfair litigation advantage, and (ii) avoid the regulatory scheme of the State of New York.

  • OIG Issues New Advisory Opinion Regarding Investment in Ambulatory Surgery Centers

    Last week, OIG considered a proposed investment by a health system, a management company, and certain surgeons in an ambulatory surgery center (ASC). OIG advised that the proposed arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (AKS) if the requisite intent were present but determined it would not impose sanctions because the arrangement involved...

  • CMS Extends CJR Model for Another Three Performance Years with Changes

    On April 29, 2021, CMS issued a final rule extending the Comprehensive Care for Joint Replacement (CJR) bundled-payment model for an additional three performance years (the Final Rule). Originally slated to end September 30, 2021, the CJR program will now extend through December 31, 2024. The Final Rule also makes a number of changes to the program moving forward, including broadening the scope

  • Southern District of Florida Dismisses RICO Claims in Putative Automotive Class Action

    On March 30, 2021, the U.S. District Court for the Southern District of Florida entered an order dismissing all but one claim against Daimler AG and Mercedes-Benz USA, LLC (collectively, the “Mercedes Defendants”) in a putative class action arising from alleged defects in the “NECK PRO” active head restraints installed in certain Mercedes-Benz vehicles to prevent whiplash from accidents. The...

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