We would like to inform you of several draft laws in the TMT area, that were adopted by the Russian Parliament, and finally signed by the President. We have prepared a short description for you below ...
Among the many liquor laws passed this legislative session by the Tennessee General Assembly, one of the biggest changes, in our humble opinion, is the new Open Carry law. P.C. 755 allows restaurants, hotels and other liquor-by-the-drink establishments to serve alcohol into common areas and allow adjacent restaurant patrons to bring alcoholic beverages into their restaurant. You can now walk between restaurants with your cocktail, glass of wine or mug of suds ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
To help further the objectives of the Women’s Health Strategy for England (published by the Department of Health and Social Care in July 2022) £1.97m has been awarded to help women in the workplace who are experiencing reproductive health issues. The grant will be shared between 16 charities which include, amongst others, Fertility Network UK, Sands, Tommy’s and Mind ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
Governor Ivey in her State of the State address on February 4 argued forcefully that Alabama must do more to attract physicians (and nurse-practitioners) to practice in the rural, under-served areas of the state. Unfortunately, one of the only current tax incentives to do so—a $5,000 income tax credit that can be claimed over a 5 consecutive year period--has been the source of many audits and administrative and Alabama Tax Tribunal appeals ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
The Minister of Transportation has issued Minister of Transportation Regulation No. PM 32 of 2016 on the Organization of Non-Fixed-Route Public-Transportation Services. This regulation addresses the ongoing dispute between the existing transportation companies and application-based transportation services ...
The Minister of Transportation has issued Minister of Transportation Regulation No. PM 32 of 2016 on the Organization of Non-Fixed-Route Public-Transportation Services. This regulation addresses the ongoing dispute between the existing transportation companies and application-based transportation services ...
Due to the non-renewal of the constitutional state of exception of catastrophe, the health authority modified the Covid-19 regulations. The main changes are mentioned below: A. STEP-BY-STEP PLAN MODIFICATION On October 1st 2021, Exempt Resolution No. 994 was published in the Official Gazette, which regulates and establishes a new version of the “Step-by-Step Plan” ...
In 2016, the Centers for Medicare and Medicaid Services (CMS) issued regulations that prohibited long-term care facilities from entering into pre-dispute arbitration agreements with residents and their families. Shortly thereafter, those regulations were successfully challenged in federal court, and CMS has not attempted to enforce them. On July 18, 2019, CMS issued a final rule that will formally rescind the ban on pre-dispute arbitration agreements with long-term care residents ...
For many years, nurses in Ohio were only required to disclose convictions to the Ohio Board of Nursing on their biennial license renewal application. However, a new regulation from the Ohio Board of Nursing now requires licensees to additionally report a guilty plea, conviction or treatment in lieu of conviction of certain crimes within 30 days of the plea or entry ...
The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains. This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies ...
Back in March 2022, a furore erupted over the mass redundancies by P&O Ferries of its workers and their replacement with an international crew on much lower wages. Amidst all the calls for changes to prevent ‘fire and rehire’ tactics, the only relevant change to employment legislation to have made it onto the statute book so far is The Seafarers' Wages Act 2023 (SWA 2023), which came into force on 23 March 2023 ...
The Federal Council of Pharmacy published Resolution No. 658/2018 to regulate publicity, advertisement and announcement of activities related to the pharmaceutical profession. Such include any disclosure arising or promoted by pharmacists, regardless of the means of communication ...
December 2, 2022 By: Anna G. Thomas To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians. Beginning on January 1, 2023, physicians will be required to comply with new patient notice and posting requirements. Notice to Patients Under this law, physicians must provide to patients an Open Payments database notice ...
A new program taking effect in March provides hospitals with a new option to secure funds for financing acquisitions and refinancing debt. On February 5, 2013, the Office of Hospital Facilities published a new rule that will enable qualifying hospitals to finance their acquisitions and/or refinance their existing debt with FHA insurance even if the hospitals do not have FHA-insured mortgages ...
Skilled nursing facilities (SNFs) billed one-quarter of all claims in error in 2009 – resulting in $1.5 billionin inappropriate Medicare payments – according to a report released by the Department of Health and Human Services’ Office of Inspector General (OIG) on November 9, 2012. The OIG noted that the majority of the inappropriate claims were upcoded, and many involved claims for so-called “ultrahigh therapy ...
Over the past decade, the Office of Inspector General for the Department of Health and Human Services (OIG) has repeatedly emphasized the important role that Boards of Directors play in ensuring that their organizations have robust and effective compliance programs. At the same time, state and federal law enforcement agencies have shown a growing interest in the role of healthcare Boards when they investigate organizations for suspected healthcare fraud ...
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 ...
Recently, the Ohio Department of Medicaid (ODM) finalized Ohio Administrative Code 5160-1-32.1 (the Final Rule) which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA Privacy Rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...
Beginning March 19, 2019, naltrexone drug products, including Vivitrol, dispensed pursuant to an outpatient prescription and indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence must be reported to the Ohio Automated Rx Reporting System (OARRS) ...
