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 ...
I. Introduction According to a Bitkom study from September 2018, German industry has incurred a total loss of 43 billion euros as a result of cyberattacks over the past two years. Seven out of ten industrial companies have been victims of such attacks during this period. At EU level, there has recently been a growing discussion on how to face this mounting danger ...
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 ...
As an eventful 2018 comes to a close, we look ahead to 2019 and our “Top 10 List” of key issues U.S. financial institutions, non-banks providing financial services, and financial technology (fintech) entities should plan for and watch throughout the upcoming year. The first five items on the list are discussed below, and the remainder of our list will follow shortly in another post ...
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, the coalition partners finalised their governing plan for the next 5 years in a coalition agreement (“Coalition Agreement”) which was signed the same day. The Coalition Agreement confirms the ambition, amongst others, to pursue a responsible, sustainable and innovative financial policy based on sound public finances ...
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 ...
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) ...
Whether you are a business pushing out an edgy ad campaign, or one with an unsolicited media crisis on your hands, in the age of the Internet you are just keystrokes away from things going “viral”. It is important to be prepared. Like many bad ideas, it started innocuously enough. In late November, Dolce & Gabbana uploaded a series of videos on its social media platforms that starred a young Chinese woman wearing a red sequin dress ...
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 ...
View a PDF of the November 2018 Edition of the Haynes and Boone Media, Entertainment and First Amendment Newsletter. Must Websites Comply With the ADA? Website ADA compliance litigation is all the rage, manifesting itself as an epidemic of “website drive-by lawsuits.” Beyond the litigation controversy, the issue is whether websites must be accessible to the visually-impaired via screen reader software to comply with the ADA. Circuit Courts are split ...
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 ...
The enactment of EU Directive 2018/843 on the prevention of the use of the financial system for money laundering or terrorist financing (the "5th AML Directive") has prompted the Luxembourg government to accelerate the final implementation process of EU Directive 2015/849. This Directive prevents the use of the financial system for the purposes of money laundering or terrorist financing (the “4th AML Directive”) ...
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) ...
Obviously, they are all natural disasters that climate scientists believe will increase in severity and intensity in the coming years. And they are all events that nursing homes and assisted living facilities (and all Medicare/Medicaid certified health care providers) are legally required to prepare for in order to protect their residents and patients. More pointedly, though, they are all events which the U.S ...
When auditing annual financial statements, auditors are required to draw attention to risks that potentially threaten the company. Such risks can result for example from failure to implement the EU General Data Protection Regulation (GDPR) that has been in force since May 25, 2018. Given the substantial fines envisaged in the GDPR, these risks can result in high provisions, in the worst case in refusal on the part of the auditor to issue an unqualified audit opinion ...
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 ...
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 ...
The Gambling Policy Division of the Irish Department of Justice has joined 14 other gambling regulators from around the globe in signing an International Declaration expressing concern about gambling in video games. The regulators presented a united front in addressing the "blurring of lines between gambling and other forms of digital entertainment". The increasing presence of gambling in the video gaming world has been raised as a growing concern ...
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) ...
