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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals
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Heuking | December 2018

Inland ports are of significant importance for handling of freight. Most inland ports are trimodal (road, railways and waterways) and have the necessary infrastructure to handle freight coming from all over the world. Recent State aid measures address the increasing importance of inland ports and allow subsidisation predominantly for constructing infrastructure ...

Heuking | December 2018

These days more and more use is being made of the Treaty rules on State aid. The European Commission is using the State aid rules in an innovative way to take over competence from the Member States in tax regulation by challenging the selectivity of national measures or rulings, which give preferable treatment to certain taxpayers ...

Veirano Advogados | December 2018

The Brazilian Federal Government recently published Medida Provisória No. 863/2018 ("MP 863/18"), a new rule that amends Federal Law No. 7,565, of December 19, 1986 (Brazilian Aviation Code) and lifts the existing restrictions to foreign capital shareholding in Brazilian air transportation companies. As a result, foreign investors are from now on able to hold up to one hundred percent (100%) of the voting capital of Brazilian airlines ...

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 ...

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

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 ...

Garrigues | December 2018

Call-off stock or consignment stock is specifically regulated, changes are introduced into chain sales, and requirements are laid down for applying the exemption to intra-Community supplies of goods ...

Arendt & Medernach | December 2018

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 ...

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 ...

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

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) ...

Dinsmore & Shohl LLP | November 2018

On Nov. 19, 2018, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking[1] requesting public comment on criteria for identifying emerging technologies essential to U.S. national security that would be subject to increased export controls ...

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 ...

Afridi & Angell | November 2018

News of a new federal law on foreign direct investment in the UAE has many people asking: “Does this mean I can now form a new company with majority foreign ownership?” The answer is the same as previously, “No, not yet”. Companies incorporated in the UAE require a minimum of 51 percent UAE ownership. As an exception to this rule, 100 percent foreign ownership is permitted in free zones. The new law may lead to further exceptions in the future ...

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 ...

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 ...

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) ...

From ground-breaking discoveries such as penicillin and insulin, to the development of the MRI body scanner and the creation of Dolly the sheep, the first mammal to be cloned from an adult cell ...

Dinsmore & Shohl LLP | October 2018

In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...

MinterEllison | October 2018

Information is critical to the conduct of health and medical research. Much of the time the information relates to individuals. Higher education institutions regularly collect, use, disclose and hold information, including health information, for research purposes ...

The oil and gas sector has seen significant changes over the past few years, led by a significant reduction in global oil prices. This has increased the focus on operational efficiency and more flexible ways of working collaboratively to alleviate the effects of protracted price deflation ...

The Scottish financial sector has always punched above its weight due, in large part, to its appetite for innovation and sharp business acumen, which it has successfully exported around the globe. The successful early establishment in Scotland of current account banking and the investment trust speak to this, along with the undisputed influence of the Scottish diaspora, which established many of the great financial institutions from Paris to Hong Kong ...

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