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 ...
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 ...
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 ...
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) ...
Key Points Governor Newsom signed into law Assembly Bill (AB) 133, which creates a $750 per day civil money penalty for skilled nursing facilities (SNF) that do not comply with a transfer, discharge, or readmission hearing decision within three calendar days. AB 133 also requires an SNF to submit a certification of compliance to the Department of Health Care Services (DHCS), attesting it has complied with the hearing officer's order ...
On December 2, 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (“Marijuana Research Act” or “Act”) into law. The Act aims to help facilitate research on marijuana, directs the Drug Enforcement Administration (DEA) to follow new procedures to register practitioners to conduct marijuana research, and improves the supply of marijuana for research ...
Below is a summary of key new measures that have been implemented by various UAE authorities since 30 April 2020 and the time of this inBrief, 12:00 noon on Thursday, 7 May 2020. I. Economic Relief Measures A ...
Below is a summary of key new measures, as well as clarifications on previous measures we reported on, that have been implemented by various UAE authorities since 5 April 2020 and the time of this inBrief, 6:00 p.m. on Tuesday, 7 April 2020 ...
Below is a summary of new developments and key new measures that have been implemented by various UAE authorities since 19 April 2020 and the time of this inBrief, 6:00 p.m. on Saturday, 25 April 2020.I. First Phase of Easing of Lockdown and Movement Restrictions in DubaiThe Supreme Committee of Crisis and Disaster Management has announced a partial reduction in the restrictions on movement in Dubai starting from Friday 24 April 2020 ...
Below is a summary of key new measures that have been implemented by various UAE authorities since 15 April 2020 and the time of this inBrief, 12:00 noon on Saturday, 18 April 2020. Dubai’s National Disinfection Programme extended On 17 April 2020, Dubai’s Supreme Committee of Crisis and Disaster Management extended the 24-hour National Disinfection Programme for another week. The programme, which began on 5 April 2020, was initially scheduled to end on 18 April 2020 ...
Below is a summary of key new measures and initiatives that have been implemented by various UAE authorities since 9 April 2020 and the time of this inBrief, 6:00 p.m. on Monday, 13 April 2020. Commercial Activity On 13 April 2020 the Dubai Department of Economic Development issued a circular on the re-opening of some commercial activities and emphasised that these activities must continue to comply with preventive guidelines, including operating only between the hours of 8:00 a.m ...
Below is a summary of key new measures that have been implemented by various UAE authorities since 25 April 2020 and the time of this inBrief, 6:00 p.m. on Thursday, 30 April 2020.I. Economic Relief MeasuresA. Abu Dhabi Global Market (ADGM) announces further incentives to support businessesOn 29 April 2020 the ADGM Registration Authority enacted incentives for new businesses, aimed at supporting the establishment of their operations amid the COVID-19 pandemic ...
Below is a summary of key new measures and initiatives that have been implemented and announced by various UAE authorities since 6 April 2020 and the time of this inBrief, 6:00 p.m. on Wednesday, 8 April 2020 ...
