On May 14, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a new final rule that will further delay the effective date of the Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary Final Rule (the Final Rule) until no earlier than Dec. 15, 2021 ...
On Sept. 15, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule, which was published on Jan. 14, 2021, and would be effective on Dec. 15, 2021. In June 2021, we reported on CMS’ decision to delay the MCIT Program Final Rule (The Rule) ...
On April 18, 2011, the Centers for Medicare and Medicaid Services (CMS) began the attestation phase under its $27 billion Medicare EHR Incentive Program. Incentive payments for the meaningful use of electronic health records (EHR) will begin in May 2011 and will continue over the next several years. Eligible professionals (i.e ...
The Centers for Medicare and Medicaid Services (CMS) has finalized its proposal to expand the experimental Home Health Value-Based Purchasing (HHVBP) Model to all 50 states and conclusively transition Medicare home health services to outcome-driven, value-based reimbursement beginning in calendar year (CY) 2023 ...
The impacts of COVID-19 appear set to permanently expand telehealth and fundamentally transform how and where providers practice. Shortly after the start of the pandemic, CMS made major temporary federal policy changes in response to the pandemic, including expanding access to telehealth services for people with Medicare, such as home health visits, and reimbursement for additional services when furnished via telehealth ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
Membership substitution transactions are the most common form of business combination transaction in the nonprofit hospital industry. They are also widely misunderstood and the source of many mistakes. Many large 501(c)(3)s have become more acquisitive as a result of economic pressures of the ACA. Nonprofit health systems have been getting much better at participating in and winning competitive sale processes, resulting in an increased use of this business combination form. http://www ...
Between September 2021 and May 2022, the words 'stress', 'mental health' and 'depression' appeared in more than 12,000 early conciliation or employment tribunal cases , demonstrating the prevalence of this subject matter in employment-related disputes. Today, more than ever, employers are expected to afford greater consideration to workplace conditions that do or could impact upon employees’ mental health ...
In Wyeth and Cordis Corp. v. Abbott Laboratories, 2012-1223, -1224 (Fed. Cir. June 26, 2013), the Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment in favor of the defendants, holding method of treatment claims invalid under 35 U.S.C. § 112(a) (2012) as not being enabled for their full scope. (Slip op. at 3) ...
We have previously reported on the order that adopted the extraordinary measures under the COVID-19 health emergency declaration, published on March 31, 2020 (the “Order”), and the Technical Guidelines regarding certain essential activities described in Order, published on April 6, 2020 ...
Earlier this year, Michigan’s Department of Licensing and Regulatory Affairs (LARA) announced the formation of “work groups” to provide input as LARA adopts emergency rules to govern activities under the State’s new Medical Marihuana Facilities Licensing Act (MMFLA). Organized around the MMFLA’s five license types, those work groups met last month ...
Superintendence Resolution Nº 000170-2021-MIGRACIONES, published last August 6, provides for the repeal of Superintendence Resolution Nº 000104-2020-MIGRACIONES (hereinafter, Resolution 104) and provides the following measures: Extension of term.-The term of temporary or resident migratory statuses granted from March 16, 2020, which expired during the validity of Resolution 104, is extended until the entry into force of this resolution ...
On 17 January 2020, the Chief Inspector of Mines for the Mine Health and Safety Inspectorate of the Department of Mineral Resources and Energy issued new guidelines and guidance notes in the Government Gazette in terms of section 49(6) of the Mine Health and Safety Act, 1996 (the "MHSA"), making these guidelines legally enforceable. These new guidelines and guidance notes must be read and interpreted in conjunction with the MHSA ...
Below, please find ENSafrica’s Mining Indaba ENSight, covering trends and recent developments impacting South Africa’s mining industry in the coming year; and the controversial issue of artisanal mining in South Africa: South Africa: legislative developments in mining in 2020 and their relation to optimising growth and investment in the digitised mining economy (Lloyd Christie) Calls to decriminalise artisanal mining (interview with Ntsiki-Adonisi Kgame, fi
On February 25, 2021, the Ministry of Health and Social Protection issued Resolution 223 of 2021 (the “Resolution”) to update the general biosecurity measures set for the management of Covid-19 in Colombia. The main novelties included in this regulation are mentioned below: 1. Scope The Resolution extended the scope of the general biosecurity measures to all "social and economic activities carried out by individuals" ...
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017 ...
On April 2, 2019, the United States Environmental Protection Agency (EPA) published its proposed “Modernizing Ignitable Liquids Determinations” rule in the Federal Register.[1] Ostensibly, the rule is, as described in its title, an effort to “modernize” – i.e., update – certain aspects of the regulations relating to determining whether a waste is a hazardous waste based on the characteristic of ignitability, which are found in 40 C.F.R. 261 ...
On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means ...
Due to the reforms and additions to the General Health Act in matters of obesity and labeling of food and non-alcoholic beverages setting a frontal warning system, published in the Federal Official Gazette (Spanish Acronym - DOF) on November 8, 2019 ...
Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...
This article provides a brief review of MSHA enforcement data and a look at MSHA’s regulatory agenda. MSHA Enforcement Data (data from January 1, 2017 to December 31, 2017) MSHA issued 104,412 enforcement actions to mine operators in 2017, an increase of approximately 11,793 or 11.3 percent from 2016. Of these, 58,083 (or 55.63 percent) were issued to metal/nonmetal operators while 46,329 (or 44.37 percent) were issued to coal operators ...
Introduction On 27 August 2020 the European Commission, on behalf of EU member states, entered into an advance purchase agreement (APA) with AstraZeneca for the production, purchase and supply of the Anglo-Swedish company's COVID-19 vaccine in the European Union.(1) The APA provides for: AstraZeneca's supply of 300 million doses of its COVID-19 vaccine (the initial Europe doses); and an option for the European Union to order an additional 100 million doses (the optional doses) ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
