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Dinsmore & Shohl LLP | January 2019

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 ...

Dinsmore & Shohl LLP | January 2019

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 ...

Dinsmore & Shohl LLP | January 2019

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 ...

TSMP Law Corporation | January 2019

Minority shareholders – often forced to silently accept the rule of the majority – should be given a voice. In May last year, Jerry Low, a minority investor in Asiatic Group (Holdings), wrote an open letter to the management highlighting concerns regarding the SGX-listed company’s poor performance, juxtaposing this against the high remuneration enjoyed by its senior management team ...

Dykema | January 2019

On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...

Dykema | January 2019

The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices ...

Heuking | January 2019

Under its Article 88(1), the GDPR allows Member States to draw up their own rules for the area of employee data protection. Germany has taken advantage of this option with Section 26 of the Federal Data Protection Act (BDSG). The first sentence of Section 26(1) already applies while the decision to establish an employment relationship is made and hence it needs to be taken into account early in the application process ...

Simonsen Vogt Wiig AS | January 2019

To protect and stimulate creators to increase innovation and encourage entrepreneurship, Norwegian authorities are changing the law. In 2018 we received several proposals towards strengthening the rights of those who create new ideas or build their business on intellectual property. Looking back at 2018, we see a year in which the Norwegian intellectual property (IP) legislation has been in movement. Technology is developing fast, and so must the law protecting technology ...

Simonsen Vogt Wiig AS | December 2018

Software is becoming the main part of an increasingly amount of products set on the market; a trend which will become more and more evident in the years to come. This fact challenges the legal landscape and interpretation of product liability laws, and contract makers must pay attention to potential new risks imposed on the parties. If a product causes damages to a third party, complex questions may arise with respect to liability and the chain of causation ...

Dykema | December 2018

CLOSE OR BE DENIED! In a major year-end development, the Michigan Court of Claims today dismissed the last of the cases that allowed unlicensed Michigan medical marihuana facilities to operate ...

Dykema | December 2018

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 ...

Dinsmore & Shohl LLP | December 2018

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 ...

Simonsen Vogt Wiig AS | December 2018

PSD2 came into effect in the European Union on January 13, 2018. PSD2 is important as it aims to further harmonise the EU payments market and break the banks' de facto monopoly on the provision of payment services and the use of their customer data. Below is a review of developments to date as they relate to transposing PSD2 into Norwegian law, including an update on the most recent developments ...

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 ...

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 ...

Heuking | December 2018

The ePrivacy Regulation was actually supposed to enter into force on May 25, 2018 jointly with the EU General Data Protection Regulation. Now it is expected to go into effect in 2019 at the earliest. It has new provisions in store, particularly for online marketing. The ePrivacy Regulation is intended to replace the current European ePrivacy Directive (2002/58/EC) and the Cookie Directive (2009/136/EC) ...

Simonsen Vogt Wiig AS | December 2018

The online retail sector has seen a considerable increase in intervention by the competition authorities both on a national level and in Brussels. Most recently, in December 2018, the European Commission fined the clothing company Guess € 39.8 million for applying online sales and advertising restrictions ...

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 ...

Heuking | December 2018

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 ...

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 ...

Dykema | December 2018

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 ...

Dykema | December 2018

Over the last several years, the emphasis on privacy and data protection has grown significantly. With the amount of data collected by companies and technology skyrocketing, the need to protect personal information has been at the forefront of states’ legislative agendas. While all 50 states now have breach notification statutes, states are now taking a closer look at issues such as tracking online behavior and the use of biometric data ...

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 ...

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