The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing an investment in an ambulatory surgery center (ASC) made by a health system, certain physicians employed by the same health system, and a management company. OIG Advisory Opinion No. 21-02 is the first advisory opinion since 2009 to provide guidance on ASC investments and related safe harbors to the Anti-Kickback Statute ...
The European Council has just adopted a new dual-use regulation. The new dual-use regulation is a recast of the current dual-use regulation and aims, among other things, to modernize European export controls in a number of areas. The regulation is directly applicable in all EU Member States and is expected to enter into force in 2021. In this Insight, Plesner's export control specialists outline the main changes resulting from the new dual-use regulation ...
For Mental Health Awareness Week, Caroline Watson, head of Shoosmiths Family Law team, offers practical advice on looking after your emotional wellbeing if you’re going through a divorce or a separation. When someone close to you dies, it’s generally accepted that there are five stages of grief: shock, denial, anger, bargaining, depression and acceptance. Some psychiatrists say that the emotional stages of a relationship breakdown are the same ...
By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...
On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...
The Ohio Board of Pharmacy recently announced it will award up to an additional 73 dispensary licenses across Ohio. Dispensary licenses will be awarded through an application and lottery process that is expected to be finalized during the spring or summer of 2021. This expansion will bring the total number of dispensary licenses in Ohio to 130 and is expected to ameliorate patient dissatisfaction with regards to the price of medical marijuana products and lack of equal access ...
On April 26, 2021, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on its OCR Security List Digest that OCR had been made aware of misleading postcards being sent to health care organizations. The postcards inform recipients that they must participate in a “Required Security Risk Assessment.,” It directs them to send their risk assessment to www.hsaudit.org, a non-governmental website marketing consulting service ...
The impact of the pandemic can be seen across all sectors of society but those who are disabled have been particularly affected, not least because employees with an underlying disability are likely to have been identified as clinically extremely vulnerable and told to shield for considerable parts of the last year. Being away from the workplace and separated from colleagues has left many feeling insecure ...
The COVID-19 pandemic has presented many novel challenges and questions for employers, from administration of Families First Coronavirus Response Act (“FFCRA”) leave to managing performance of remote workers. For healthcare providers, these challenges and questions have been only one of many burdens of operating during a pandemic. As vaccines become more widely available, the pandemic raises new challenges, some unique to employers in the healthcare industry ...
As part of its 2022 Inpatient Prospective Payment System (IPPS) Proposed Rule for Acute Care Hospitals, the Centers for Medicare and Medicaid (CMS) is proposing an increase for Medicare fee-for-service payment rates to acute care hospitals by 2.8 percent, or $3.4 billion in Fiscal Year (FY) 2022.[[1]] Hospitals hoping to receive the payment increase must successfully participate in the Hospital Inpatient Quality Reporting Program and be meaningful electronic health record users ...
New Promulgated Law and Subsequent Regulations on Health, Administrative and Other Measures during Covid-19 Outbreak In response to the recent community outbreak of Covid-19 on 20 February 2021, the Royal Government of Cambodia (“RGC”) promulgated and issued a number of regulations, specifically: Law on Preventative Measures against the Spread of Covid-19 and other Highly Contagious Diseases dated 11 March 2021 (“Preventative Measures Law”); Sub-Decree 37 dated 12 Ma
On April 8, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that some of the blanket waivers implemented during COVID-19 will expire on May 10, 2021.[1] The following waivers will expire: The emergency blanket waivers related to notification of resident room or roommate changes, and transfer and discharge notification requirements ...
The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use ...
When President Biden announced in December 2020 that he intended to nominate California Attorney General Xavier Becerra to head the Department of Health and Human Services (HHS), the appointment raised eyebrows in certain policy circles. Becerra does not fit the typical administrative profile of past HHS heads. In fact, he has no actual experience in health care or public health policy. Rather, his background is primarily rooted in law enforcement ...
As an employer, are you obliged to search personal devices, personal email accounts and/or personal social media accounts belonging to employees or others such as trustees or non-executive directors when responding to a data subject access request (DSAR)? Many employers will now be familiar with undertaking a ‘reasonable and proportionate’ search when responding to an employee’s DSAR under Article 15 of the UK GDPR ...
Did you know? The Chinese National Intellectual Property Administration (CNIPA) revised Patent Examination Guidelines came into force on 15 January 2021. The changes significantly relax the patentability requirements for inventions in the pharmaceutical, chemical and biotech field. Why does this matter to you? The revised guidelines focus on the examination criteria for novelty and inventive step in relation to the rapidly developing field of chemical and biotech inventions ...
Further to the decline of the Covid-19 spread in Israel after the successful vaccination rollout, Israel has announced changes in foreign entry policy into the country, which will allow, among others, the regular entry of foreign experts and businessmen. These reliefs come after several months in which the state borders were almost completely closed to foreigners ...
On March 26, 2021, the Internal Revenue Service (“IRS”) published Announcement 2021-7, which notifies taxpayers that certain amounts paid for personal protective equipment (such as masks, hand sanitizer, and sanitizing wipes) for the primary purpose of preventing the spread of COVID-19 (“COVID-19 PPE”) may be an eligible expense that can be reimbursed from certain health care account based plans ...
Earn-outs are a commonly used payment mechanism in overseas and cross-border M&A transactions. Through earn-outs, transacting parties can set flexible metrics to adjust the buyer’s payment obligation and thereby allocate the risks and benefits between the buyer and seller ...
A recent study by the UK Advertising Standard’s Authority (ASA) has found that the majority of social media influencers are (still) breaking consumer and advertising laws. The ASA’s report, “Influencer monitoring report (March 2021)” (the ‘Report’) was undertaken as part of the ASA’s commitment to have more impact online, as well as be more proactive in their regulation and demonstrates its increased monitoring function ...
On April 8, 2021, the Center for Medicare & Medicaid Services (“CMS”) announced a proposed rate increase of 1.3 percent for skilled nursing providers in fiscal year 2022. It is estimated this will result in approximately $444 million increase in payments to skilled nursing facilities (SNF) under Medicare Part A for the fiscal year. This increased payment rate does not incorporate the SNF Value-Based Program (VBP) reductions that CMS estimates to be $184 ...
Gennex Media LLC, a customizable product online marketplace, and its sole officer and shareholder Akil Kurji, have agreed to an FTC consent decree resolving allegations the company falsely claimed its Brandnex novelty products were “Made in USA,” “USA MADE,” and “Manufactured Right Here in America!” when, in many instances, they were wholly imported from China ...
On 24 March 2021, the EU Member States agreed to begin negotiations with the European Parliament concerning a legislative proposal on health technology assessment. Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare ...
