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Dinsmore & Shohl LLP | July 2017

It has been four months since the changes to 42 CFR Part 2, the confidentiality regulations that apply to all substance abuse treatment records, became effective. Ensure your policies and forms have been updated. The finalized changes to 42 CFR Part 2 by the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), took affect March 21, 2017 ...

Dinsmore & Shohl LLP | July 2018

On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings ...

Waller | March 2015

Don Stuart, a partner in Waller’s Tax Practice Group and current Chair of the Tax and Finance Practice Group of the American Health Lawyers Association (AHLA), and Kim Looney, partner in the firm’s Healthcare Compliance and Operations group, are authors on two chapters in the AHLA’s new publication The ACO Handbook: A Guide to Accountable Care Organizations, Second Edition ...

Lavery Lawyers | June 2016

On May 10, 2016, the Québec Court of Appeal1 confirmed a Superior Court decision allowing an application for authorization of treatment and placement to a patient. The application had been brought by the Douglas Mental Health University Institute, commonly known as the Douglas, or the Douglas hospital ...

Sponsored wellness plans that include incentives to employees who voluntarily disclose personal health information as part of disability-related inquiries or medical examinations are in legal limbo after the EEOC removed the underlying rules from the Americans with Disabilities Act (“ADA”) and Genetic Information Nondiscrimination Act (“GINA”) ...

PLMJ | May 2021

Decree-Law 36/2021, which amends Decree-Law 176/2006 of 30 August ("Medicines Statute"), was published on 19 May. The new Decree-Law introduces a ban on the advertising of discounts on the price of medicines subject to medical prescription that are reimbursed by the National Health Service ("NHS") or that contain narcotic or psychotropic substances ...

ENSafrica | November 2020

IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...

Carey Olsen | September 2021

The President characterised this initiative as one necessary to counter "a pandemic of the unvaccinated", stating, "This is not about freedom or personal choice.  It’s about protecting yourself and those around you" ...

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 ...

Waller | May 2016

Following up on the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Department of Health and Human Services (HHS) recently issued a proposed rule to replace the Medicare sustainable growth rate (SGR) methodology which was repealed by MACRA. The proposed rule would implement the Merit-based Incentive Payment System (MIPS) to replace SGR and establish incentives for participation in Advanced Alternative Payment Models (Advanced APMs) ...

Waller | April 2016

A number of events have occurred recently involving the Federal Trade Commission and healthcare entities. First, garnering the lead spotlight, the FTC began presenting its case in the U.S. District Court for Northern Illinois to enjoin a merger between Advocate Health and NorthShore University HealthSystem, two large Chicago-area health systems ...

Dykema | September 2021

In a move that should significantly ease traveling to the United States, the Biden Administration has announced plans to withdraw COVID-related geographic travel restrictions in early November ...

Carey | March 2020

In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...

Ellex Valiunas | September 2012

Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...

Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace ...

Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas ...

Lavery Lawyers | September 2006

As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...

ALRUD Law Firm | October 2020

On September 18th, 2020, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) adopted a new Order approving the criteria for blocking the websites with the content infringing the healthcare regulations. The document establishes criteria for identifying and blocking websites that illegally sale or distribute content that forms a positive image of persons engaged in prohibited retail trade of medicines ...

Schwabe, Williamson & Wyatt | September 2022

During the COVID-19 pandemic, questions about employee health-privacy-related symptoms, testing, and vaccination became prevalent in discussions about the workplace at all levels—from “the water cooler” to national news ...

Dykema | January 2019

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”) ...

Carey | September 2021

Kindly note that Decree No. 221, of the Ministry of the Interior and Public Security, was published today, extending the validity of Supreme Decree No. 102, of 2020, of the Ministry of the Interior and Public Security, which provides for the temporary closure of places authorized for the entry and exit of foreigners, due to public health emergency of international importance given the outbreak of the new Coronavirus (2019-NCOV) , until September 30, 2021 ...

Buchalter | July 2020

California’s cannabis-related businesses will face a dual battle in complying with Proposition 65 requiring businesses to warn the public about cancer-causing chemicals present in products they purchase, writes Buchalter’s Anne Marie Ellis. Businesses are going to have to change their labeling and packaging to list marijuana smoke as a reproductive toxicant and cancer causing agent ...

Waller | January 2021

The second HIPAA settlement of 2021 is the first traditional enforcement action of the year. And, it’s a big one. Traditionally, OCR enforcement has been triggered by breaches. In 2020, however, we saw a significant increase in a sub-set of Privacy Rule enforcement arising out of the U.S. Department of Health and Human Services’ Office for Civil Rights’ (OCR) patient “Right of Access” initiative ...

Haynes and Boone | April 2012

In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...

Waller | July 2016

On July 7, 2016, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intended to prohibit hospitals operating certain off-campus provider-based departments (PBDs) from billing under the Outpatient Prospective Payment System (OPPS). In an effort to implement Section 603 of the Bipartisan Budget Act of 2015, CMS says the proposed rule will save about $500 million a year by refocusing payments on the patient rather than the clinical setting ...

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