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 2011 Texas Legislature adopted broad changes to eminent domain laws that take effect on September 1, 2011. Under the new law, public and private entities that hold condemnation power face important new requirements and deadlines ...
Effective September 1, 2010, the Texas Railroad Commission issued new regulations for oil and gas operators related to inactive onshore wells and associated equipment pursuant to House Bill 22591 which dramatically changed requirements for extension of plugging obligations for inactive wells. Certain aspects of the regulations and the original law currently are under review, and amendments to HB 2259 are expected to be introduced in the current legislative session ...
With more than 6-months of delay, the Government of the Republic of Serbia finally adopted the following package of decrees setting out the new incentive scheme for green energy:Decree on the Power Purchase Agreement, ("PPA Decree");Decree on incentive measures for the production of electric energy from renewable energy sources and from high-efficiency cogeneration of electric energy and thermal energy (" View More
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” ...
A proposed Act on Wind Power Plant Projects presented in February 2016 is intended to specify the rules for siting of wind farms. But the current version of the proposal generates a huge risk for further growth of the wind power sector and for wind farms already in operation and even for persons interested in building housing near existing wind projects. The issue of siting of wind farms near other construction has created a lot of confusion ...
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 ...
The new regulation of the Polish Minister of Economy on electricity and heat generated from renewable sources of energy goes into effect at the beginning of 2013. The new regulation will increase the share of renewables in the production of electricity and heat ...
On March 1st, 2016, Supreme Decree N° 62 of the Ministry of Economy, introduced in 2006 (hereinafter, the “Decree 62”), that regulates capacity transfers among power generation companies entered into force, modifying the methodology used to calculate transfers.IntroductionThe Chilean electric system remunerates power generation companies for two products: energy and capacity ...
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 ...
Decree N° 50/2015, issued by the Ministry of Public Works, has been enacted. This act approves the Regulation that sets the technical conditions to be fulfilled during the design, construction and operation stages of hydraulic works, as defined in Article 294 of the Water Code.Through this Decree, the Ministry of Public Works has set the text for the Regulation of Large Public Hydraulic Works, which had been pending enactment since 1981 ...
Introduction Based on the final report submitted on September 29 2009 by a working group established by the Ministry of Employment and the Economy, on March 11 2010 the government submitted a draft for proposal to Parliament on new legislation in relation to a feed-in tariff system for electricity produced by renewable energy ...
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 ...
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 ...
On July 1, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule[1] outlining financial penalties, referred to as “disincentives” throughout the rule, for healthcare providers that engage in conduct that is considered “information blocking.” The 21st Century Cures Act defines information blocking as a “practice that interferes with, prevents, or materially discourages access, exchange, or use of electronic health information ...
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 ...
The Office of Comptroller of the Currency (“OCC”) issued a revised Handbook for examination of Oil and Gas Exploration and Production Lending on March 16, 2016 (the “March 2016 Handbook”). This March 2016 Handbook replaces and significantly revises the OCC’s prior version issued April 9, 2014, which is no longer available on the OCC website (the “April 2014 Handbook”) ...
