On Sept. 30, IBM won dismissal of a federal False Claims Act (FCA) qui tam suit, Cimino v. IBM, No. 13-cv-00907 (APM), 2019 U.S. Dist. LEXIS 168059 (D.D.C. Sept. 30, 2019). In the suit, Relator Paul A. Cimino alleged IBM, assisted by Deloitte LLP, fabricated audit findings regarding Internal Revenue Service (IRS) usage of IBM-licensed software to coerce IRS into renewing its software enterprise license ...
On May 17, 2021, the United States Health Resources and Services Administration (HRSA) publicly disclosed letters which were sent to six major pharmaceutical manufacturers. HRSA’s letters expressly state that each manufacturer is currently in violation of the Federal 340B Program statute as a result of policies restricting contract pharmacies and covered entities from access to 340B Program discounted medication ...
On Sept. 22, 2021, the U.S. Health Resources and Services Administration (HRSA) publicly referred six matters involving drug manufacturers to the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) for possible imposition of civil monetary penalties (CMPs) ...
The U.S. Health Resources and Services Administration (HRSA) recently released a draft final rule (Final Rule) that establishes a binding administrative dispute resolution (ADR) process concerning drug costs under the Federal 340B Drug Discount Program (340B Program). As per its terms, the Final Rule will be formally published on Dec. 13, 2020 and will take effect on Jan. 13, 2021 ...
The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...
Dinsmore partner James Reid was recently published in Bank Director with his article "How to Minimize Individual Liability for Employment-Related Claims," an excerpt of which is below ...
The Multifamilly and Healthcare Facility divisions of HUD are a bit like two different dialects of the same language; both offer mortgage insurance under the Federal Housing Administration, but each has its own distinct rules and conventions on underwriting, closing and asset management. Being conversant in one dialect doesn’t necessarily equip you to get by in the other ...
On June 13, 2019, the Mine Safety and Health Administration (MSHA) announced it had completed its upgrade of its Mine Data Retrieval System (MDRS). Under the new system, mine operators will have new tools to help review compliance with MSHA regulations as well as assessing employment and production records. The upgraded system will also enable mine operators to track accidents, inspections, violation history, and health sampling data ...
While many people begin to work from home in an effort to practice social distancing, it is important to remember that corporate needs still arise for many individuals and their businesses. Effective 5:00 p.m. on March 18, 2020, the Kentucky Secretary of State’s office closed to walk-in services. Additionally, Kentucky government agencies, including the Secretary of State’s office, have been asked to reduce staffing by 50 percent and work remotely ...
As Seen In Bank Director Cybersecurity incidents and data compromises continue to plague financial institutions on a seemingly daily basis. Without a proper response plan in place, financial institutions risk significant damage to their reputation and operations, as well as serious potential liability from regulators and class-action litigation. This guide outlines the procedures financial institutions should implement to prepare for and respond to a cybersecurity incident ...
With COVID-19 vaccines fully available in the United States, employers are approaching work-from-home requests differently than they were a year ago. Dinsmore labor and employment attorneys Ashley Pack, Crystal Spivey Wildeman and Aly St. Pierre wrote about the topic in Best Lawyers: The Litigation Issue. An excerpt is below. Employers are facing legal uncertainty in the form of whether to accommodate continued remote-work requests ...
As early as September 23, 2019, the United States House of Representatives is expected to vote on the widely anticipated Secure and Fair Enforcement (SAFE) Banking Act ...
Governor Mike DeWine signed House Bill 75 on June 29, 2021, appropriating budget funding for the Ohio Bureau of Workers’ Compensation (BWC) for the 2022-2023 biennium and enacting some pro-employer changes to workers’ compensation law ...
It is well established under Ohio law that an injured worker is not eligible to participate in the workers' compensation system for a psychological condition unless it arises from their physical injury. While this remains the case, an exception is being considered to allow first responders to receive benefits should they experience post-traumatic stress disorder due to on-the-job factors. In Armstrong v. John R. Jurgensen Co ...
A recent California decision provides clarity on a lender’s ability to charge late fees for missed loan payments, which should be of interest to all lenders operating in California. In Honchariw v. FJM Private Mortgage Fund, LLC, et al.,[1] the California First District Court of Appeals held that late payment fees assessed against the entire unpaid principal balance of a loan constitutes unlawful penalties under California Civil Code Section 1671 ...
On April 1, 2020, the U.S. Department of Labor (“DOL”) issued a temporary rule regarding the implementation of the emergency paid sick leave and Expanded Family and Medical Leave (“EFMLA”) requirements established by the recently enacted Families First Coronavirus Response Act (“FFCRA”). The DOL temporary rule covers significant ground in terms of delineating workers’ and employers’ rights and responsibilities under the FFCRA ...
Two recent Supreme Court decisions concerning the First Amendment affect when the government can regulate speech. Dinsmore's Justin Burns and Brady Wilson wrote about the cases for Law360 Expert Analysis. An excerpt is below and the full PDF is above. Recent headlines from the U.S. Supreme Court focus on leaks, but City of Austin v. Reagan National Advertisements of Austin and Shurtleff v. City of Boston, two recent First Amendment decisions, are also worth noting ...
On Friday, March 13, 2020, the Department of Health and Human Services (HHS) announced several waivers of existing Centers for Medicare and Medicaid (CMS) regulations pursuant to Section 1135(b) of the Social Security Act, including the waiver of certain Emergency Medical Treatment and Active Labor Act (EMTALA) obligations and Medicare conditions of participation during the COVID-19 pandemic ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations (collectively the HIPAA Rules) ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable Care Act (ACA) (the Proposed Rule). The Proposed Rule would revise certain provisions of the current Section 1557 rule that federal courts have ruled as likely unlawful, and eliminate the requirement that covered entities publish non-discrimination notices and include taglines in foreign languages on all significant publications ...
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 November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021. At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
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 ...
