The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
The Federal Trade Commission’s increased focus on the antitrust implications of healthcare mergers and acquisitions has been widely publicized. While scrutiny has largely been directed toward hospital and health system transactions, a recent case in Nevada indicates that the FTC is now taking an interest in relatively small provider combinations in highly concentrated markets ...
Presidential Decree no. 229/20 of 8 September 2020 has been published and its aim is to reassess the measures imposed by Presidential Decree no. 142/20, considering the evolution of the epidemiological situation. The new decree renews most of the measures already in force, although it also eases some restrictions ...
Driven by the passion and belief, and fraught with various risks and challenges, the research and development of innovative drugs and medical devices is a journey that's never easy. Along the journey, an individual may stride resolutely, yet with companionship, two can traverse faster and farther ...
Earlier this month, the United States Department of Justice (“DOJ”) filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities (“Vitas”) alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill ...
We knew this year was going to be an especially bad one for the flu. In its November 2019 issue, Scientific American, one of the country's leading science publications, included a twenty-page article titled "The Influenza Outlook", which highlighted the escalating threat of influenza for the year 2020. Unfortunately, at present, the emergence and spread of the novel coronavirus makes the flu pale by comparison ...
All eyes were on health care in 2020, as the industry faced unprecedented challenges presented by the global coronavirus pandemic. Stories and images of overburdened frontline health care workers dominated the news cycle for most of the year, and the rapid development of one or more seemingly effective vaccines has engendered a cautious optimism for a return to normalcy in 2021 ...
On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments1 ...
On 9 July 2020, the Employment (Amendment) Bill 2019 (Bill) was passed at the Legislative Council. The Bill introduces amendments to the Employment Ordinance (Ordinance) to extend the statutory maternity leave period from 10 weeks to 14 weeks, and technical amendments to rationalise the current statutory maternity leave regime (Amendments). We summarise the effect of the Amendments as follows: Current position New position 1 ...
On June 28, 2005, amendments to Articles 420 and 421 as well as the addition of a new Article 414bis of the Health Law were published in the Federal Official Gazette, entering into force the following day. Article 414bis provides that herbal products, food supplements, perfumes and beauty products may be seized, as a precautionary measure, when they have been improperly advertised by being held out as medicines or as having characteristics or therapeutic qualities which they do not have ...
In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021 ...
This week we learned that Amazon, Berkshire Hathaway and J.P. Morgan Chase have joined forces to tackle employee healthcare costs. This announcement marks yet another chapter in some employers' frustration with our nation’s healthcare system. Employees are equally tired of the increasing cost of healthcare eating away what should be their wage increases even as employers pay for ever increasing health insurance premiums ...
The Biden administration is instructing the Department of Labor’s Occupational Safety and Health Administration (OSHA) to develop a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work ...
The home health industry could see its profit margins shrink further as a result of proposed updates to the Home Health Prospective Payment System (HH PPS) released by the Centers for Medicare & Medicaid Services (CMS) earlier this week. This is the fourth and final year of payment reductions mandated by the Affordable Care Act in response to perceived Medicare overpayments to home health agencies. Profit margins are estimated to average 17.2% for the home health industry, and $17 ...
Late last week, 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 ...
On January 23, the Internal Revenue Service published its long-awaited final rule on intermediate sanctions in the Federal Register. Proposed regulations were published in 1998, followed by temporary and proposed regulations in January 2001. The rule implements the excise taxes on excess benefit transactions under Section 4958 of the Internal Revenue Code, which was enacted by the Taxpayer Bill of Rights ...
CMS approved the Alabama Medicaid Agency’s applicationfor a 1115 Demonstration on October 21, 2021. The 1115 Demonstration, in combination with a 1915(c) Home and Community-Based Services (“HCSB”) Waiver and a 1915(i) Medicaid State Plan HCBS Program, will facilitate the creation of a new Community Waiver Program (the “Program”) ...
When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis ...
We have been in the UAE helping clients manage and survive crises for 45 years, and these are unprecedented times in our lives. We will have to work together to overcome the challenges brought about by the COVID-19 pandemic, and we at Afridi & Angell are ready to do our part. Until the end of March, we will offer free advice on legal issues affecting companies and employers as a result of the COVID-19 pandemic ...
ENSafrica recently released Africa Regulatory Insight: Coronavirus (COVID-19) Regulatory Measures. This comprehensive report outlines the COVID-19 regulatory measures for each country across Sub-Sahara Africa, providing the sector, measure, effective date/status and key points and impact for each region. The information provided herein is intended to provide a general overview, and is not an exhaustive list of all legislatice developments across Sub-Sahara ...
Consent to End-of-Life Care Article 11 of the Civil Code of Québec1 states that no one can be made to undergo care without his consent. The Act respecting end-of-life care2 ("the Act"), passed by the National Assembly of Québec, came into force on December 15, 2015. Since that date, a person can give or refuse consent to specific forms of end-of-life care, provided he has given advance medical directives ("AMDs") for that purpose ...
As we stated in our bulletin last week, on March 31st, the federal government outlined proposed actions relating to Accountable Care Organizations (ACOs), a key component of the healthcare reform legislation (the Affordable Care Act, or ACA) enacted in March 2010. In this bulletin, we provide some additional information regarding each of the March 31st releases ...
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 ...
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 ...
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+ ...
