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ALTIUS/Tiberghien | December 2018

An expert panel of the Pro League (the organization representing the interests of all professional Belgian football clubs) appointed by the latter and presided by Belgian minister of State, Melchior Wathelet, was consulted on the role of football agents within the current Belgian football landscape. The panel was asked to formulate recommendations and ‘best practice’-proposals to the Pro League ...

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 ...

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 ...

TSMP Law Corporation | December 2018

Whether you are a business pushing out an edgy ad campaign, or one with an unsolicited media crisis on your hands, in the age of the Internet you are just keystrokes away from things going “viral”. It is important to be prepared. Like many bad ideas, it started innocuously enough. In late November, Dolce & Gabbana uploaded a series of videos on its social media platforms that starred a young Chinese woman wearing a red sequin dress ...

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 ...

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) ...

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 ...

A&L Goodbody LLP | November 2018

The Gambling Policy Division of the Irish Department of Justice has joined 14 other gambling regulators from around the globe in signing an International Declaration expressing concern about gambling in video games. The regulators presented a united front in addressing the "blurring of lines between gambling and other forms of digital entertainment". The increasing presence of gambling in the video gaming world has been raised as a growing concern ...

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) ...

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

What needs to happen to secure the most sought-after international events on the sporting calendar? As Australia continues its reputation as a dependable major sports event host through the likes of the Gold Coast 2018 Commonwealth Games and the Invictus Games Sydney 2018, there has been an upsurge in interest from Australian cities, metropolitan and regional, to host major sporting events ...

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 ...

A&L Goodbody LLP | October 2018

As part of Budget 2019, the Irish Minister for Finance announced that Irish betting tax will increase from 1% to 2% of turnover. Betting intermediary tax will also increase from 15% to 25%. The tax increases will take effect from 1 January 2019. Parties in support of this increase have suggested that additional revenue generated by this increase should be directed towards gambling addiction services ...

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 ...

TSMP Law Corporation | October 2018

Traditional news organisations are facing a battle for survival but will they find a new mission in the battle against Fake News? Stefanie Yuen Thio shared her views in an article published by the Business Times on September 15, 2018 ...

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