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 ...
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 ...
Most companies go to great lengths to protect and maintain their intellectual property (IP). These companies recognize the value of their IP and work towards its development, sustainability and commercialization. IP strategy customary includes where and when to file patent applications, how to choose a brand name and register it, how to protect and enforce copyrights, protect trade secrets, etc ...
On 26 October 2018, the Standing Committee of the National People's Congress approved a decision to revise the Company Law of the People’s Republic of China (Revision), with the aim of supplementing and improving the existing share repurchase regime. We have set out a brief introduction to this Revision below. Background It has only been five years since the last revision to the Company Law of the People’s Republic of China (Company Law) ...
In the latest development in an eventful year, Federal Decree-Law 24 of 2018 introduces amendments to the Federal Penal Code, originally enacted as Federal Law 3 of 1987. The amendments are designed to make the Penal Code consistent with other recent federal legislation and current federal enforcement policies. Only ten provisions of the statute have been affected, out of the more than 400 total articles contained in the statute ...
Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now ...
Michigan voters approved Proposal 1 and made Michigan the twelfth U.S. jurisdiction to legalize recreational marijuana. The Michigan Regulation and Taxation of Marihuana Act (MRTMA) went into effect December 6. What has been lost in all the smoke from the past several weeks is how MRTMA impacts the regulation of industrial hemp ...
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 ...
The end is near. 2018 is fast coming to a close, and it is that time of year when corporate lawyers are counting—not the number of shopping days left until Christmas, but the number weeks, days and hours left before the end of the fiscal year. Admittedly, in the scramble to close deals, insurance requirements and indemnity provisions may not be at the top of the list of critical deal points for clients and counsel ...
Executives and in-house counsel should be aware that traveling with sensitive data can lead to its seizure—with potentially severe consequences worldwide. Recently, Parliament in the United Kingdom seized from a traveling executive a USB drive containing data that had been produced in a United States lawsuit between Six4Three, a software company, and Facebook. Put simply, that data was in the wrong place at the wrong time ...
Medicare and Medicaid certified nursing homes are frequently required to pay fines (called “civil money penalties” or “CMPs”) to the U.S. Centers for Medicare and Medicaid Services (“CMS”) when government surveyors find them out of compliance with the Requirements for Participation for Long-Term Care Facilities. It is not uncommon for CMS to assess CMPs in the hundreds of thousands of dollars ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...
In December of 2018, EU Court of Justice Advocate General Campos Sánchez-Bordona concluded that the United Kingdom may unilaterally withdraw its intention to leave the European Union before 29 March 2019 and therefore remain in the EU. This is so long as the revocation notice is made before the formal conclusion of a withdrawal agreement and it respects the UK’s constitutional requirements ...
In February of this year, the Securities Exchange Commission issued its updated Statement and Guidance on Public Company Cybersecurity Disclosures. In April, the SEC issued an Order that, among other things, levied a $35 million fine against Yahoo! Inc. for failing to properly report a 2014 data breach. These actions support the view that the SEC is consciously committing attention and resources to cybersecurity issues affecting public companies ...
As in previous years, the California legislature kept busy in 2018. As a result, a number of new and noteworthy employment laws will go into effect on January 1, 2019, and beyond. Much of the legislation stems from the #MeToo movement by strengthening harassment and discrimination protection, imposing broader anti-harassment training obligations, updating lactation accommodations and mandating female presence on boards of public companies ...
The UAE federal government has recently issued a raft of important legislation. The raft addresses and updates areas of law that are key to businesses in the jurisdiction. Amongst this legislation is Federal Decree-Law 14 of 2018 concerning the central bank and the organisation of financial institutions and activities (the New Banking Law) ...
Since the GDPR has been in force, almost every company has, among other things, dealt with issues of the permissibility of direct marketing and other marketing activities under data protection law. At their data protection conference on Nov. 07-08, 2018, the German data protection supervisory authorities issued a new "orientation guide" on this topic (as of November 2018) ...
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 ...
The large number of vague terms as well as provisions requiring interpretation in the GDPR create significant application issues for companies. However, it becomes even more of a challenge if companies not established in the EU want to review whether the GDPR is applicable to them. Generally speaking, the European legislator set themselves the goal of creating the most extensive territorial scope of the GDPR possible ...
The new anti-money laundering (AML) law of the UAE took effect at the end of October 2018. Containing features recommended by the Financial Action Task Force (FATF), the new law introduces subtle but important changes to the AML landscape in the UAE. The new law was enacted as Federal Decree-Law 20 of 2018. The previous AML law was Federal Law 4 of 2002, as amended by Federal Law 9 of 2014, and the implementing regulations that were promulgated pursuant to Cabinet Resolution 38 of 2014 ...
