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The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...

Dinsmore & Shohl LLP | March 2020

As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements. In this context, the U.S ...

Dinsmore & Shohl LLP | April 2019

On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site).  Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...

Dinsmore & Shohl LLP | June 2022

On June 15, 2022, the Supreme Court of the United States released its long-awaited decision in American Hospital Association v. Becerra in which it unanimously held that the United States Department of Health and Human Services (HHS) overstepped its statutory authority by cutting 340B-related reimbursement to hospitals ...

Waller | March 2018

You may have heard something about GDPR lately and thought "Why should I care? It probably won't affect me or my business.” In reality, the implications of GDPR are far-reaching. The European Union’s General Data Protection Regulation (GDPR) is a set of regulations strengthening data privacy and protection laws for residents of the EU. The regulations take effect in just two months: May 25, to be exact ...

Waller | June 2020

Amid the unprecedented changes wracking the business world in 2020, one certainty remains: many industries will look very different in future years as strategic responses to COVID-19 gain traction and become permanent. In the healthcare REIT sector, we are beginning to see trends that may shape industry norms long after the dust has settled from the chaos of 2020. 1 ...

Waller | September 2020

The impact of COVID-19 and the economic downturn has pressured independent hospitals, rural hospitals and smaller health systems in particular. Despite the immense challenges, independent facilities and their Boards should take this time to best position for the near- and long-term. In light of this, Waller partnered with Kaufman Hall to develop a guide for healthcare leaders, The Health System Growth Imperative: Charting Opportunities During the Pandemic and Beyond ...

Waller | October 2011

On October 20th, the federal government released a final rule and other companion releases relating to Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (MSSP), a key component of the Affordable Care Act enacted in March 2010. The proposed rule, issued in March 2011, generated extensive comment from the healthcare industry ...

Waller | February 2014

CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014 ...

Lavery Lawyers | December 2008

On May 22, 2008, the Supreme Court of Canada rendered its decision in a case involving the notion of reasonable foreseeability in negligence actions. This judgment, written by the Chief Justice, confirms that tort law must compensate harm done on the basis of reasonable foresight, and must not be considered as insurance ...

Waller | December 2020

Apparently, the OCR has a different concept of the holiday spirit than many others do. On December 22, OCR announced the 13th settlement agreement related to its Right of Access Initiative. This time, the provider settled for $36,000 and agreed to enter into a corrective action plan. This latest matter involved Peter Wrobel, M.D., P.C., d/b/a Elite Primary Care ("Elite"). The situation follows a very familiar pattern: a patient requested records but did not receive them ...

Shearn Delamore & Co. | July 2020

Introduction The Covid-19 global pandemic which has swept the globe and caused many countries to introduce various degrees of lock down measures has given rise to various issues and scenarios which an employer must deal with and manage. This is no different for employers in Malaysia where the Government has implemented the Movement Control Order (“MCO”) since 18 March 2020 which saw the economic activity brought to a halt ...

Lavery Lawyers | September 2015

On August 18, 2015, the Tribunal administratif du Québec (TAQ) confirmed the decision of a health institution to not renew the status and privileges of one of its physicians after he refused to undergo refresher training to acquire skills that were necessary to perform his new duties.1 The physician in question, a hematology specialist, had been hired as a researcher several years ago ...

As the overall level of convergence between industries in the business world keeps increasing, it is only logical for the related legal aspects to follow suit every step of the way ...

Waller | March 2020

Rural and community hospitals could fill a major gap in a healthcare system that will likely be overloaded, in varying degrees, for at least the next 18 months due to the COVID-19 global pandemic. Congress is in the process of passing the Coronavirus Aid, Relief, and Economic Security Act (“the Cares Act”) that provides unprecedented relief designed to help business in general, but specific allocations for hospitals ...

Haynes and Boone | June 2011

On June 16, 2011, the Supreme Court issued an opinion in Smith v. Bayer allowing a plaintiff to pursue class certification in a state court action after a federal court had denied certification in a substantially similar case. The Court held that it was improper for the federal court to enjoin the state proceeding under the “relitigation exception” of the Anti-Injunction Act because the issues were not identical and the state court plaintiff was not a party to the federal lawsuit ...

Hanson Bridgett LLP | September 2022

Key Points AB 890 gave Nurse Practitioners who meet certain requirements authority to practice more independently. The bill created two categories of Nurse Practitioner—one that may perform delineated functions without the use of standardized procedures in certain clinical settings where physicians and surgeons practice and another that may perform these functions and more outside of such clinical settings ...

Haynes and Boone | August 2002

HIPAA Privacy Primer for Group Health Plans The HIPAA Privacy regulations will apply to group health plans beginning on April 14, 2003. The HIPAA Privacy regulations require changes in group health plan contracts and operations and impact the entire organization sponsoring the group health plan ...

Lavery Lawyers | June 2005

On May 20, 2005, the Supreme Court issued its judgment in the Smith & Nephew Inc. v. Louise Glegg and Christopher Carter and Gilles Dextradeur v. Louise Glegg cases1 ...

Waller | October 2011

Today the federal government released final rules for the formation and operation of Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program. The regulations initially proposed in March 2011 generated considerable attention and comment as ACOs represent a key component of the Affordable Care Act, the healthcare reform legislation enacted in 2010 ...

Haynes and Boone | April 2011

Accountable Care Organizations (ACOs) will face large start-up costs under proposed rules issued on March 31, 2011 by the Centers for Medicare and Medicaid Services (CMS), with an uncertain outlook for savings and even possible losses. An ACO is an organization of health care providers that agrees to be accountable for cost, quality and the overall care of Medicare beneficiaries who are assigned to it ...

Haynes and Boone | March 2015

On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) Innovation Center released its newest model in alternative care delivery: the Next Generation ACO Model. This new version of accountable care organization (ACO) builds upon the experiences from the Pioneer ACO Model and the Medicare Shared Savings Program (MSSP) to set more predictable financial targets, enable providers and beneficiaries to better coordinate care, and provide overall high quality care ...

Shoosmiths LLP | May 2022

Aaron Harlow and Ian Hardman examine the tough new measures that are being taken to force the real estate industry to pay to remove cladding - protecting leaseholders from costs. The Department for Levelling Up, Housing and Communities (DLUHC) has requested that residential property developers fund and undertake all necessary remediation of buildings over 11m that they have had a role in developing. This includes buildings both 11-18m and 18m+ ...

In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...

by Eric E. Kinder President Bush signed the ADA Amendments Act into law. The ADAAA significantly increases the scope of the Americans with Disabilities Act of 1990 as it has been interpreted by federal courts by overturning several United States Supreme Court decisions regarding the Act. According to the Congressional Committees that oversaw the passage of the ADAAA, these amendments will restore the original Congressional intent behind the ADA ...

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