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Afridi & Angell | December 2018

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latest development in an eventful year, Federal Decree-Law 24 of 2018 introduces amendments to the Federal Penal Code, originally enacted as Federal Law 3 of 1987.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 ...

Deacons | December 2018

“Arbitration agreement” is defined under section 19 of the Arbitration Ordinance (Cap 609) as an agreement by the parties to submit to arbitration all or certain disputes which have arisen or which may arise between them in respect of a defined legal relationship, whether contractual or not. Disputes submitted to arbitration may involve contractual claims and non-contractual claims, such as tortious claims ...

Dykema | December 2018

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 ...

Dinsmore & Shohl LLP | December 2018

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 ...

Dinsmore & Shohl LLP | December 2018

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 ...

Haynes and Boone, LLP | December 2018

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 ...

Dykema | December 2018

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 ...

Hanson Bridgett LLP | December 2018

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 ...

Dykema | December 2018

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 ...

Haynes and Boone, LLP | December 2018

The U.S. Supreme Court heard oral arguments on December 4, 2018, inHelsinn Healthcare SA v. Teva Pharmaceuticals USA Inc.as to whether the “on-sale” bar under the America Invents Act (“AIA”) renders an inventor’s private sale to a third party as prior art for purposes of determining patentability. 35 U.S.C ...

Dinsmore & Shohl LLP | 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 ...

Dinsmore & Shohl LLP | November 2018

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 ...

Haynes and Boone, LLP | November 2018

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 ...

Dinsmore & Shohl LLP | November 2018

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) ...

TSMP Law Corporation | November 2018

While the motivation behind the Civil Justice Commission’s consultation paper – aimed at enhancing the Court system – is laudable, the proposed introduction of litigation scale costs may hurt Singapore’s standing as a global litigation hub. In 2015, the Chief Justice established the Civil Justice Commission (CJC) to review Singapore’s civil justice system, with the goal of transforming and modernising the litigation process ...

Dykema | November 2018

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 ...

Dinsmore & Shohl LLP | November 2018

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 ...

Shearn Delamore & Co. | November 2018

The Construction Industry Payment and Adjudication Act 2012 (“Act”) was introduced to address cash flow issues affecting contractors in the construction industry as a result of delays and/or lengthy periods of payment under construction contracts. Under the Act, an unpaid party [1] is entitled to initiate an adjudication proceeding in order to claim any amounts due and/or owing to them under a construction contract ...

Shearn Delamore & Co. | November 2018

This case highlights the importance of registering a franchise with the Registrar of Franchises and the consequences of not doing so. In particular, the effect and applicability of section 6(1) of the Franchise Act 1998 (“FA 1998”) are discussed. Facts The subject matter was “Dr. Fong’s Method” of teaching mathematics to students in primary and secondary school, which was developed by Dr. Fong Ho Kheong (“Dr. Fong”). Dr ...

Dinsmore & Shohl LLP | November 2018

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 ...

Afridi & Angell | November 2018

In an order dated at the end of 2018, the DIFC Court accepted that a party seeking an anti-suit injunction against proceedings in a foreign court must show that proceeding before the foreign court is or would be “vexatious or oppressive” to that party ...

Dinsmore & Shohl LLP | November 2018

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 ...

Deacons | November 2018

In the Court of Appeal (CA) decision of Securities and Futures Commission v Cheng Chak Ngok (CACV 95/2017; [2018] HKCA 590), the less disputed element of insider dealing, namely the element of “dealing” was at issue. As there was no direct evidence showing the dealing in this case, the issue was whether the circumstantial evidence was sufficient to draw inferences that there was in fact dealing in the relevant shares ...

Dinsmore & Shohl LLP | November 2018

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) ...

Haynes and Boone, LLP | October 2018

View the PDF version of the October 2018 IP Beacon. Jason Bloom Co-Authors SCOTUS Amicus Brief for INTA in Key Copyright Case The International Trademark Association (INTA) tapped Haynes and Boone Partner Jason Bloom to co-write an amicus brief inFourth Estate Public Benefit Corporation v. Wall-Street.com, LLC, a pending U.S. Supreme Court case that will address a key issue regarding when copyright owners can sue for infringement ...

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