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 ...
On January 21, 2019, Google was fined nearly $57 million (approximately 50 million euros) by France’s Data Protection Authority, CNIL, for an alleged violation of the General Data Protection Regulation (GDPR).[1] CNIL found Google violated the GDPR based on a lack of transparency, inadequate information, and lack of valid consent regarding ad personalization. This fine is the largest imposed under the GDPR since it went into effect in May 2018 and the first to be imposed on a U.S ...
The use of marijuana in patient care has undergone widespread growth and acceptance nationwide. Thirty-three states and the District of Columbia have laws authorizing the use of marijuana in some form. Two of those states – Utah and Missouri – joined that list this past mid-term cycle, as voters passed initiatives authorizing the use of medical marijuana. Others, such as Kentucky and Virginia, have pending legislation seeking to authorize the use of medical marijuana ...
Now that the holidays are in the rearview and business as usual has begun to pick up where it left off, it’s time for public companies to do a deep download of key securities law updates and business developments of the past year so they are positioned for success in 2019. Below is a review of the 2018 proxy season, along with a summary of new and anticipated changes that may impact reporting and disclosure requirements for the 2019 proxy season ...
The U.S. Court of Appeals for the Sixth Circuit, in Massachusetts Bay Insurance Company v. Christian Funeral Directors, Inc., No. 18-5267 (6th Cir. Dec. 26, 2018), recently upheld a district court’s declination of jurisdiction over an insurer’s declaratory judgment action on coverage ...
In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...
The U.S. Court of Appeals for the Sixth Circuit, in Massachusetts Bay Insurance Company v. Christian Funeral Directors, Inc., No. 18-5267 (6th Cir. Dec. 26, 2018), recently upheld a district court’s declination of jurisdiction over an insurer’s declaratory judgment action on coverage ...
Recently, the Ohio Department of Medicaid (ODM) finalized Ohio Administrative Code 5160-1-32.1 (the Final Rule) which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA Privacy Rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...
Why is April 1, 2019 Important? April 1, 2019 is the first day U.S. Citizenship and Immigration Services (USCIS) may accept H-1B specialty worker petitions for the next fiscal year, which begins October 1, 2019 ...
On December 23, 2018, new State Medical Board of Ohio regulations became effective which marked another change in the legal standards governing provider use of opiates for treatment of pain ...
Beginning January 1, 2019, employers in Illinois will have new requirements for reimbursing employee expenses. An amendment to the Illinois Wage Payment and Collection Act (IWPCA) is the first Illinois law regulating employer reimbursement for employees’ business-related expenditures. Previously, the IWPCA did not address employee reimbursement, so employers were free to implement their own rules and procedures for reimbursing employees for business expenses ...
On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system ...
Often, board of education members believe what happens in executive session, stays in executive session. However, you and your board’s members, both new and old, are well-served to remember that many issues, including those involving personnel, discussed in executive session are communications that may be subject to discovery in a deposition or other legal proceeding by an affected employee ...
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 ...
Educational institutions (“recipient” or “recipient institutions”) have been waiting for the Department of Education to issue formal Title IX regulations after it issued interim guidance in September 2017. This interim guidance rescinded previous Obama-era guidance that called for strict enforcement of Title IX and indicated that new formal guidance would be forthcoming ...
In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...
On Nov. 19, 2018, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking[1] requesting public comment on criteria for identifying emerging technologies essential to U.S. national security that would be subject to increased export controls ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
In the last quarter of 2018, the Office of the Inspector General (OIG) announced that ImmediaDent of Indiana, LLC (ImmediaDent), which operates nine dental care practices, and Samson Dental Partners, LLC (SDP), which provides administrative support to Immediadent, have agreed to pay the United States and the state of Indiana $5.1 million to resolve allegations that they improperly billed Indiana’s Medicaid program ...
In the last quarter of 2018, the Department of Labor (DOL) issued an opinion letter ending what had become known as the “80/20 rule” for tipped employees. The new rule, which eases restrictions on an employer’s application of the tip credit, is a reissuance of a 2009 opinion letter that had been supplanted by contrary guidance since 2011 ...
Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed Rule), which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA privacy rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...
Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...
One year later, the #MeToo movement has caused a seismic cultural shift in American society and in the workplace. It continues to gain momentum and attracts wide-sweeping media coverage keeping the issue of sexual misconduct against women at the forefront of our national dialogue ...
In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...
