The Centers for Medicare & Medicaid Services (“CMS”) has announced its proposed rules for the Hospital Outpatient Prospective Payment (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment Systems, as well as its calendar year (CY) 2024 proposed Physician Fee Schedule (“PFS”), (collectively the “Proposed Rules”) ...
In its second tranche of major standards reduction, The Joint Commission will eliminate or consolidate 210 accreditation standards across many of its programs. The modification to the affected standards will be effective August 27, 2023. The reduction is part of a major review effort of Joint Commission requirements announced in September of 2022 ...
The concept of "patient-centered" has become the core guiding principle in current research and development ("R&D") of drugs. "Patient-centered" drug R&D refers to the process of drug discovery, design, implementation and decision-making based on the patient's point of view, with the aim of efficiently developing clinically valuable drugs that better meet the needs of patients ...
This year, the Federal Trade Commission (the “FTC”) and the Department of Justice (the “DOJ”) have been modifying antitrust guidance related to healthcare, and recently enacted three notable changes. First, the FTC and DOJ jointly issued updated Draft Merger Guidelines (the “Draft Guidelines”) to address the way the agencies evaluate a merger to determine its effect on competition ...
On July 9, 2023, the State Council of the People's Republic of China[1] promulgated the Regulations on Supervision and Administration of Private Investment Funds ("Regulations"), which will take effect from September 1st, 2023 ...
On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval Items and the Scope and Procedures for Filing and Prior Reporting of Human Genetic Resources, which unveiled six documents, including the administrative guidelines on collection approval, biobanking approval, exportation approval and international collaboration approval of human genetic resources ("HGRs"), as well as the scope and procedures for int
On 13 July 2023, the UK government planned increases to fees across a range of immigration and nationality routes including the immigration health surcharge. The immigration health surcharge (IHS) is set to see a huge increase of around 66%. The current standard IHS rate is £624 per person per year of leave to remain granted and this will increase to £1,035. Similarly, the discounted rate for students and under-18s will increase from £470 per year to £776 ...
Today's judgment from the European Court of Justice ("ECJ") in the case Commission v CK Telecoms (C-376/20 P) provides insight into how the EU merger control provisions should be assessed in consolidated markets, such as telecommunications. Understanding the judgment may be relevant for consolidation plans in many industries with tendencies towards oligopoly ...
We look at the latest events concerning the dispute between the UK Covid-19 Inquiry and the Cabinet Office over the former Prime Minister’s WhatsApp messages and diaries ...
As the latest signal in the priority of the Duty to Report in Ohio, the State Medical Board has updated its Duty to Report video.[1] The video is offered by the Board for physicians to fulfill the mandatory continuing medical education (CME) component of the license renewal process in Ohio. Introduced in a new regulation on May 31, 2021,[2] the Board began mandating one hour of CME on the topic of the legal duty to report misconduct ...
A month after nixing the “objectively reasonable interpretation” (Safeco) defense under the False Claims Act, the Supreme Court has vacated and remanded two other cases for further consideration of the defendant’s subjective state of mind when it filed payment claims with the government. The Fourth Circuit in Sheldon and the Eleventh Circuit in Olhausen will provide the first tests of the High Court’s newly minted FCA intent standard ...
Figures published in May by the Department for Business and Trade (DBT) record a further decline in Trade Union membership in the UK. Comparable data is only available as far back as 1995, but shows a clear decline over that nearly 30-year period to a level where, as at 2022, the proportion of UK workers in a union has declined to 23.1% - the lowest figure recorded in that time period ...
On September 17, 2022, Exempt Decree No. 63 of the Ministry of Health was published in the Official Gazette, approving Technical Standard No. 226 of the Ministry of Health, which set forth the obligation to implement a data registration system that allows the traceability of medical devices when they are received by institutional healthcare providers ...
On June 29, 2023, the Supreme Court of the United States handed down its much-anticipated decision in Abitron Austria GmbH, et al. (“Abitron et al.”) v. Hetronic International, Inc. (“Hetronic”) regarding the extraterritorial reach of the Lanham Act, the comprehensive trademark statute in the United States ...
As part of Rail Safety Week 2023, Health and Safety specialist Hayley Saunders looks at personal liability and how employees across all levels of a business can make a difference by positive individual contribution to workplace culture. Below is a summary of key takeaways from the webinar. Responsibility for workplace safety rests with employers and employees alike ...
The United States Supreme Court has held an individual’s private right of action to sue a public nursing home for violations of federally protected rights in Health and Hospital Corporation of Marion County v. Talevski. The Court held that a private individual could sue for rights protected by the Federal Nursing Home Reform Act (“NHRA”), which sets the federal minimum quality standards for nursing homes to ensure that seniors receive quality care ...
The FSR addresses such distortions and closes a regulatory gap. Subsidies granted by non-EU governments (so called third states) currently go largely unchecked, while subsidies granted by Member States are subject to scrutiny under EU State aid rules. The FSR includes new tools to effectively tackle foreign subsidies that cause distortions and undermine the level playing field in the internal market ...
As sustainable development and social responsibility are increasingly stressed in the business community, major institutional investors have come to focus on environmental, social, and governance (ESG) investing, an approach that directs socially responsible investment decisions ...
From recovering after a global pandemic to the war in Ukraine, the collapse of Silicon Valley Bank to soaring inflation, and supply-chain delays to employee shortages, businesses across all sectors are coming up against a number of operational and liquidity challenges in current market conditions. Despite these challenges, we have seen confidence and resilience across all sectors with investment from seed to IPO ...
In a recent survey conducted by Fertility Network UK, 40% of patients undergoing fertility treatment admitted to experiencing suicidal feelings, with the majority feeling that they would benefit from counselling. Sadly, this support is not readily available and reportedly only half of those in need have access. Often, the only option is to go private, but with sessions estimated to be between £10-£70 per session, that is not always feasible for everyone ...
We look at the legal framework within which the dispute between the UK Covid-19 Inquiry and the Cabinet Office over the former Prime Minister’s WhatsApp messages and diaries has developed, and possible consequences for the Inquiry depending on the outcome. What has the Cabinet Office been asked to provide? On 21 April 2023, Baroness Heather Hallett, Chair of the UK Covid-19 Inquiry (‘the Inquiry’) issued a Section 21 Notice to the Cabinet Office (‘the Notice’) ...
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
The SEC has published its final rule for the modernization of share repurchase disclosures. The final rule will require additional details of an issuer’s share repurchase activity. Unlike the previous requirements for share repurchase reporting, the final rule will require daily repurchase data, reported either quarterly or semi-annually, and eliminates the previous requirement for the publication of an issuer’s repurchase data by month in its 10-Qs and 10-Ks ...
