Court Limits Authority of DOJ to Dismiss Relator Claims April 23, 2019 TheGranston Memoraised concerns that the U.S. Department of Justice (DOJ) would employ its authority under 31 U.S.C. § 3730 tounderminequi tamrelator actions. Since the Memo was issued, the DOJ moved to dismiss 11 Anti-Kickback Statute cases brought by a professional relator, the National Health Care Analysis Group (“NHCAG”) ...
The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
SEC and PCAOB To Take Action on Section 404 Internal Controls Reporting Matters The SEC recently announced a series of actions it and the PCAOB intend to take to improve the implementation of the internal control reporting requirements of Section 404 of the Sarbanes-Oxley Act of 2002. These actions include: • Providing Guidance for Companies ...
Things To Think About This Proxy Season Prior to Drafting Update director and officer questionnaires, including “independence” criteria for directors Most public companies follow the “best practice” of having all directors and executive officers complete a standard form of questionnaire each year to verify the accuracy of information about the person that is reported in the 10-K Report and proxy statement ...
Strong contracting processes and communications which establishes clearly the expectations of each of the parties reduces disputes and costs and strengthens relationships. The key to strong contracting processes is to approach contracts in a holistic manner making sure all documents interconnect in a logical uniform manner. Because manufacturing processes can be complex, this is often not as easy as it sounds ...
We regularly work with financial institutions to navigate the challenges of implementing, maintaining, and using security procedures for commercial customers’ use of treasury management services. Security procedures are an integral part of the relationship between the financial institution and its commercial customers ...
Texas LawyerMarch 14, 2019By Rodrigo Figueroa According to ERCOT, the entity that oversees 90 percent of the State’s grid, as of January 2019 there was nearly 1,500 megawatts of installed utility-scale solar capacity in the ERCOT region, with that number expected to almost triple to 4,300 megawatts by the end of 2020 (one megawatt is enough to power about 200 homes in Texas during times of high-peak demand) ...
One of the key provisions of the Dodd-Frank Act rollback law signed by President Trump on May 24, 2018, hasn’t met its early promise for U.S. community banks. Recently proposed rules to implement simplified capital requirements have fallen short of the industry’s expectations when the bank deregulation law was enacted in May ...
On May 7, 2018, Michigan’s version of the Uniform Commercial Real Estate Receivership Act (the “Act”) will go into effect—bringing long-overdue clarity to the laws surrounding receivers and receiver-managed properties. For decades, lenders, borrowers, owners, property managers, and other parties in business (or litigation) with receiver-managed properties in Michigan have had to rely upon a patchwork of case law and the limited guidance offered by MCR 2 ...
Under the Consolidated Omnibus Budget Reconciliation Act (COBRA), employers who provide group health plans and have 20 or more employees must offer continuation coverage to “qualified beneficiaries” who have lost health coverage as a result of certain qualifying events. This article addresses a number of common COBRA-related issues ...
The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331 ...
Earlier this year, in an effort to clarify what types of employee handbook rules are lawful under the National Labor Relations Act (“NLRA”), the General Counsel of the National Labor Relations Board (“NLRB”) issued new 1Guidance on the topic. Determining which rules are permissible and which may violate the NLRA has troubled both union and non-union employers in recent years due to the Obama-era NLRB’s tendency to find that standard handbook rules (e.g ...
Expansive Law Aimed at Predictive Scheduling for Workers, Limiting Employers’ Ability to Unilaterally Change Work Hours On July 24, 2019, the City of Chicago enacted the “Fair Work Week Ordinance,” requiring that many businesses provide workers with up to two-weeks advance notice of their work hours and schedules ...
Through the recently issued Paycheck Protection Program (PPP) Loan Forgiveness Application and Interim Final Rule on Loan Forgiveness, the Small Business Association (SBA) has once again demonstrated that the contours and requirements of the PPP program are constantly evolving. The SBA’s recent Interim Final Rule on SBA Loan Review Procedures provides some insights on how the SBA will enforce PPP qualification and forgiveness requirements ...
The United States’ Centers for Disease Control and Prevention (CDC) has issued an order that will take effect on January 26, 2021, requiring all arriving international airline passengers to provide proof of a negative COVID test taken within three days of the flight’s foreign departure. For those who have had it, the CDC will require proof of recovery ...
In 2017, the Cayman Islands passed the Data Protection Law (“DPL”), which reads much like the upcoming European Union General Data Protection Regulation (“GDPR”) that goes into effect Mary 25, 2018. The DPL applies to entities falling within the definition of “data controller” who are established in the Islands or who process data in the Islands. The DPL divides data into two categories, personal data and sensitive data ...
Insight on Eligibility and Requirements for Obtaining Financial Assistance For Mid-Sized Companies and Eligible Businesses (other than Air Carriers and Businesses Critical to MaintainingNational Security) The Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) provides for various loans, loan guaranties and other forms of financial assistance to U.S. businesses both small and large and in specific industries and sectors ...
The emergence of COVID-19 has changed the workplace as we once knew it. California employers need to be prepared for unprecedented compliance challenges in recent legislation related to the ongoing pandemic, expanding leave protections, wage and hour compliance risks, and much more. Employers will need to review and adapt their policies and procedures in order to keep up in the coming year with California’s ever-changing employment laws ...
As Michigan employers begin to think about how many employees to bring back to work, one option to consider is Michigan’s Work Share program, whereby total work hours are spread across a large group of employees as opposed to having fewer employees return to work on a full-time basis ...
Cryptocurrencies have captured the imaginations of individuals and emerging businesses drawn to their potential to serve as alternative stores of value, to reduce transaction costs by eliminating intermediaries. Most notably in popular culture and media - to provide eye-catching opportunities for speculative investing ...
Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...
On January 19, 2019, federal Magistrate Judge Kandis Westmore of the Northern District of California denied the Government’s application for a search warrant that sought: “all digital devices” present at a California residence; (Order at 3), and “any individual present at the time of the search to press a finger (including thumb) or utilize other biometric features…for the purposes of unlocking the digital devices found in order to permit a search of
