Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...
On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1] The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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) ...
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 ...
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 ...
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 ...
