Firm: All
Practice Industry: Environmental, Healthcare & Pharmaceuticals, Life Sciences
Region: All
Country/ State: All
Tag: All
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 ...

Schwabe, Williamson & Wyatt | December 2018

The Supreme Court has handed down one of the most anticipated Endangered Species Act (ESA) rulings in recent years. In Weyerhaeuser Co. v. U.S. Fish and Wildlife Serv., the Supreme Court unanimously overruled the Fifth Circuit Court of Appeals, holding that the Fish and Wildlife Service can only designate property that is “habitat” as critical habitat under the ESA ...

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) ...

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 ...

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 ...

MinterEllison | October 2018

The Australian life sciences and biotech sector is likely to continue its resurgence over the next twelve months, with global trends driving strong M&A activity in life sciences and biotech M&A. We have identified 6 key themes for activity in this sector. Three Key Opportunities  1. Demographic Trend According to the Australian Institute of Health and Welfare, healthcare expenditure in Australia is growing faster than population growth and GDP growth ...

With investors such as the Scottish Investment Bank, the soon-to-be-launched Scottish National Investment Bank and the Epidarex Life Sciences Fund all increasingly paying attention to the life sciences sector against the backdrop of an increasingly competitive life sciences market in Scotland, now is a great time to consider whether your business is ready for investment, and how it could be standing out in order to attract investors ...

A&L Goodbody LLP | October 2018

The High Court judgment in Friends of the Irish Environment v. An Bord Pleanála (delivered in 2018 by Meenan J) decided that if a Section 5 referral is made by a third party, then the owners and occupiers of the lands must be identified and served with notice of the referral, and given an opportunity to make submissions in accordance with basic fair procedures ...

In Scots law, it is possible to acquire certain rights to land – access, for instance – simply by the passage of time. This process is known as “prescription” and is outlined in the Prescription and Limitation (Scotland) Act 1973. There are two forms of prescription: positive and negative. Negative prescription extinguishes certain rights after a period of time ...

Haynes and Boone, LLP | October 2018

The UKCS is the largest decommissioning market in the North Sea. There are around 475 fixed facilities, over 10,000 kilometres of pipeline and approximately 5,000 wells. These will all need to be decommissioned over the next 30 years, when they reach the end of their economic life, at an estimated cost of £59.7 billion ...

MinterEllison | October 2018

In Australia, we're seeing enormous opportunities and some policy challenges in renewable energy ...

ENS | October 2018

Feeling the heat: the draft Climate Change Bill, 2018 Earlier this year, the South African Minister of Environmental Affairs (the “Minister”) published the draft Climate Change Bill, 2018 for public comment. Since then, the Department of Environmental Affairs (“DEA”) has undertaken a road show across the country to solicit comments to the Bill and held further bilateral meetings with stakeholders earlier this year ...

Simonsen Vogt Wiig AS | October 2018

On 1 January 2020, the maximum allowable sulfur content of marine fuels will be drastically reduced from the current 3.50% to 0.5% m/m. 2020 is rapidly approaching, but is the shipping industry really prepared? In this article, we provide an overview of the regulations and the main alternatives for compliance that shipowners and operators are faced with. Introduction On 1 January 2020, the maximum allowable sulfur content of marine fuels will be drastically reduced from the current 3.50% to 0 ...

Dinsmore & Shohl LLP | October 2018

In response to questions regarding the legality of Cannabidiol (CBD) oil products, the State of Ohio Board of Pharmacy (Board) announced that only licensed and operating Medical Marijuana Control Program dispensaries may sell CBD oil products. In June, the Board announced the award of 56 provisional medical marijuana dispensary licenses. All of those provisional licensees will have six months to comply with operational requirements in order to obtain a certification of operation (COO) ...

Dinsmore & Shohl LLP | October 2018

On September 20, 2018, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced settlements with three Boston hospitals for disclosing Protected Health Information (PHI) to ABC News documentary filmcrews.[i] In total, the hospitals paid OCR $999,000 to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule ...

dots