On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site). Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...
On March 25, 2019, the Office of Federal Contract Compliance Programs (OFCCP) released its Corporate Scheduling Announcement List (CSAL). The CSAL was released in the OFCCP FOIA Library. This is the first time the OFCCP has not mailed the advanced courtesy notification to covered contractors and subcontractors, posting only in the FOIA Library ...
A key capability for a successful attorney is effective negotiation skills to resolve conflict and legal disputes. Negotiating over 1000 such disputes for clients and serving as a mediator in over 100 cases, has been a tremendous education on how to successfully resolve conflict ...
“You can’t have confidence unless you are prepared. Failure to prepare is preparing to fail.” — Coach John Wooden Once you have developed the facts (who, what, when, where, why and how) and the law pertaining to your dispute or conflict, you need to prepare for your negotiation or mediation. Coach John Wooden stated “You can’t have confidence unless you are prepared. Failure to prepare is preparing to fail ...
As part of the #MeToo movement, many new laws, regulations, and workplace policies regarding sexual harassment have been enacted. As a result, we are seeing an increased number of claims involving harassment. Courts and parties are favoring mediation more often with these claims because of the sensitivity of some situations and the desire for confidentiality and a quick resolution. This is especially so with claimants who are minors or who are victims of prior abuse ...
The proverb is true – it does take two to tango. It is equally true in mediation. For adversaries to reach a resolution, they need to come to terms on the merits. To maximize the chances of a successful resolution, they should also be of the correct mindset. I have found that one mindset maximizes the chances of success. “Win/Lose.” By definition, parties come to mediation with a dispute. Frequently, the parties are embroiled in litigation ...
A trio of federal statutes often referred to collectively as the P&A Acts, which includes the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI), the Developmental Disabilities Assistance and Bill of Rights Act (PADD), and the Protection and Advocacy of Individual Rights Act (PAIR), authorize the creation and operation of a protection and advocacy system (P&A system) to monitor the care of individuals with mental illness and developmental disabilities ...
The IRS recently modernized the public approval process (“TEFRA approval”) for private activity bonds (“bonds”) for TEFRA approvals given on or after April 1, 2019. States and political subdivisions issuing bonds, or on whose behalf bonds are issued (“issuers”), and states and political subdivisions whose geographic jurisdiction contain the site of a project (“hosts”) may take advantage of these new rules ...
Employers in Kentucky are now expressly permitted to require an employee or prospective employee to agree to arbitrate or engage in some form of alternative dispute resolution as a condition of employment. On March 25, 2019, Gov. Matt Bevin signed a statutory amendment authorizing this change to KRS § 336.700. This law applies retroactively to agreements that have already been executed by employees before March 25, 2019. This amended statute does a number of things ...
As seen in Bank Director A bank’s board of directors must answer to a variety of constituencies, including shareholders, regulatory agencies, customers and employees. At times those constituencies may have competing interests or priorities. Other times, what may appear to be competing interests are actually variations of aligned interests ...
The West Virginia Ethics Commission issued a new Advisory Opinion on March 7, 2019, which is going to impact the way some teachers arrange for substitutes. The opinion sought was whether it is a violation of the Ethics Act for teachers to prearrange a relative to substitute teach in their absence or place relatives on a preferred list of substitutes for their classrooms ...
Beginning March 19, 2019, naltrexone drug products, including Vivitrol, dispensed pursuant to an outpatient prescription and indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence must be reported to the Ohio Automated Rx Reporting System (OARRS) ...
On March 7, 2019, the U.S. Department of Labor (DOL) proposed a rule that would significantly change the pay standards for overtime exemptions under the Fair Labor Standards Act (FLSA). Since 2004, the minimum salary necessary to qualify for an administrative, executive, or professional exemption under the FLSA has been $455 per week ($23,660 per year). Under the proposed rule, this minimum would increase to $679 per week ($35,308 per year) ...
Senate Bill 273 goes into effect on March 20, 2019, and creates new requirements for Ohio insurance companies, including health insurance plans, to develop and implement specific information security programs to safeguard nonpublic business and personal information. Senate Bill 273 is based upon the National Association of Insurance Commissioners’ Insurance Data Security Model Law (also referred to as "MDL-668") ...
The Ohio medical marijuana market saw a robust start to sales on January 16, 2019. First-day sales totaled more than $75,000, per the state’s Medical Marijuana Control Program, and total sales exceeded $330,000 in the first several weeks. This initial sales boom is magnified by the fact that only five of the 50-plus state-approved provisional dispensaries are operational (and only four on the initial date of sales) ...
Issuers and borrowers who enter into continuing disclosure undertakings on or after February 27, 2019 in connection with the offering of municipal securities will be required to report two new material events. The Securities and Exchange Commission (SEC) is implementing the amendment to Rule 15c2-12 of the Securities Exchange Act of 1934 (Rule 15c2-12) by virtue of Release No ...
USCIS recently announced that beginning March 11, 2019 it will require use of a new version of Form I-539 Application to Extend/Change Nonimmigrant Status, a form commonly used to extend or change the status of H-4 and L-2 dependents. USCIS stated it will also require use of a new Form I-539A, Supplemental Information for Application to Extend/Change Nonimmigrant Status ...
On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts ...
On December 28, 2018, the Department of Health and Human Services (HHS), in partnership with the Health Sector Coordinating Council (HSSC), published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP Publication), which is a four-volume publication designed to provide voluntary cybersecurity practices to health care organizations of all types and sizes, ranging from local clinics to large health care systems ...
On January 25, 2019, the National Labor Relations Board (Board) returned to the common-law agency test for determining whether workers qualified as independent contractors. SuperShuttle DFW, Inc., 367 NLRB No. 75 (2019) The decision expressly overrules the Board’s decision in FedEx Home Delivery, 361 NLRB 610 (2014), enf. denied 849 F.3d 1123 (D.C. Cir. 2017) ...
The Department of Health and Human Services Office for Civil Rights (OCR) has published a Request for Information on Modifying HIPAA Rules to Improve Coordinated Care (RFI). OCR announced the publication of the RFI through a December 12, 2018 press release available here. OCR Director Roger Severino stated that OCR is “looking for candid feedback about how the existing HIPAA regulations are working in the real world and how we can improve them ...
Employers, as you settle into 2019 and solidify your plans and objectives for the year, consider adding worksite immigration compliance to your to-do list. In 2018, the Trump administration held true to its Buy American, Hire American policy. As a result, worksite investigations, I-9 audits, and criminal and administrative worksite-related arrests surged by 300 to 750 percent over 2017 ...
Employers, as you settle into 2019 and solidify your plans and objectives for the year, consider adding worksite immigration compliance to your to-do list. In 2018, the Trump administration held true to its Buy American, Hire American policy. As a result, worksite investigations, I-9 audits, and criminal and administrative worksite-related arrests surged by 300 to 750 percent over 2017 ...
Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic. EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...
Generally, mediation and its process are foreign to most litigants. With the possible exception of the parties’ lawyers and insurance adjusters, often even the most sophisticated business clients have never been in mediation and do not fully understand the process or know what to expect. Frequently, as the mediator, in the early stages of the day I hear: “It is not my fault ...
