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) ...
One of the key issues raised consistently in the discussions around a no-deal Brexit is the impact it would have on the customs duties payable on goods that are imported in to the UK. Whilst MPs have now voted against a no-deal Brexit, this does not change the legal position – that unless a deal is agreed, there will be a no-deal Brexit, (or no Brexit at all) ...
Sponsored wellness plans that include incentives to employees who voluntarily disclose personal health information as part of disability-related inquiries or medical examinations are in legal limbo after the EEOC removed the underlying rules from the Americans with Disabilities Act (“ADA”) and Genetic Information Nondiscrimination Act (“GINA”) ...
Senate Bill 273 goes into effect on March 20, 2019, and creates new requirements for Ohio insurance companies, including health insurance plans, to develop and implement specific information security programs to safeguard nonpublic business and personal information. Senate Bill 273 is based upon the National Association of Insurance Commissioners’ Insurance Data Security Model Law (also referred to as "MDL-668") ...
The Ohio medical marijuana market saw a robust start to sales on January 16, 2019. First-day sales totaled more than $75,000, per the state’s Medical Marijuana Control Program, and total sales exceeded $330,000 in the first several weeks. This initial sales boom is magnified by the fact that only five of the 50-plus state-approved provisional dispensaries are operational (and only four on the initial date of sales) ...
On February 13, 2019, Assembly Member Ash Kalra, District 27 (San Jose), introduced AB-506. If passed, AB-506 would amend California Health and Safety Code Sections 1423, 1424, and 1424.5 to grant the Department of Public Health the authority to issue more citations and higher penalty amounts ...
One of the few things that is becoming clearer amidst the Brexit fog is that a ‘no-deal’ is no longer a fanciful possibility. The UK Government, in itsWhite Paper on Immigration Reformpublished at the end of last year, claimed the changes it proposed would lead to the most significant changes to immigration control in 45 years. However, that historic change, scheduled for December 2021, may come sooner than anticipated ...
The Scottish Government has published its first two Scottish Procurement Policy Notes (SPPNs) for 2019, both of which relate to public procurement in Scotland in the event that the UK exits the European Union without an agreement (a ‘no-deal’ Brexit), and has published accompanying draft legislation to implement the changes it proposes. The first policy note (SPPN 1/2019) sets out the Scottish Government’s proposed changes to public procurement legislation ...
Introduction The United Arab Emirates (the UAE) promulgated legislation to specifically address the regulation of competition (being Federal Law 4 of 2012, or the Competition Law) several years ago but until recently, it has been the case that the requisite implementing regulations and processes were not in place. This is no longer the case ...
On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts ...
The Financial Conduct Authority (FCA) recently launched a consultation on its proposed guidance on cryptoassets (CP19/3) which can be read in fullhere. The move comes as part of the UK Cryptoasset Taskforce's wider look into the regulation of the cryptoasset market. The consultation follows a report published in October 2018 by the Taskforce, which consists of the Bank of England, HM Treasury and the FCA. Our discussion of that report can be readhere ...
One of the biggest challenges that micro, small and medium enterprises face when trying to settle in and achieve success as profitable businesses is to obtain capital and sources of financing ...
On December 28, 2018, the Department of Health and Human Services (HHS), in partnership with the Health Sector Coordinating Council (HSSC), published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP Publication), which is a four-volume publication designed to provide voluntary cybersecurity practices to health care organizations of all types and sizes, ranging from local clinics to large health care systems ...
The Department of Health and Human Services Office for Civil Rights (OCR) has published a Request for Information on Modifying HIPAA Rules to Improve Coordinated Care (RFI). OCR announced the publication of the RFI through a December 12, 2018 press release available here. OCR Director Roger Severino stated that OCR is “looking for candid feedback about how the existing HIPAA regulations are working in the real world and how we can improve them ...
In late November 2018, the Securities and Commodities Authority (SCA), the Dubai Financial Services Authority (DFSA) of the Dubai International Financial Centre (DIFC) and the Financial Services Regulatory Authority (FSRA) of the Abu Dhabi Global Market (ADGM) announced that they had reached agreement on facilitating the licensing of domestic funds by each authority for promotion across the UAE. This is a potentially significant development ...
Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic. EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...
On January 28, 2019, the California Department of Social Services issued a letter informing all licensed Residential Care Facilities for the Elderly that Title 22, Section 87224 of the California Code of Regulations has been revised. Section 87224 previously provided for a 30-day eviction notice to residents upon the change of use of a facility. This notice period was inconsistent with the applicable statute, Health and Safety Code Section 1569.682(a)(2) ...
“I don’t want a British passport for myself but should I get one for my child?” This is a common immigration-related enquiry, and one my team and I have been asked about by EU nationals repeatedly since the June 2016 referendum vote ...
“I don’t want a British passport for myself but should I get one for my child?” This is a common immigration-related enquiry, and onemy team and Ihave been asked about by EU nationals repeatedly since the June 2016 referendum vote ...
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 ...
The use of marijuana in patient care has undergone widespread growth and acceptance nationwide. Thirty-three states and the District of Columbia have laws authorizing the use of marijuana in some form. Two of those states – Utah and Missouri – joined that list this past mid-term cycle, as voters passed initiatives authorizing the use of medical marijuana. Others, such as Kentucky and Virginia, have pending legislation seeking to authorize the use of medical marijuana ...
During 2017-2018, the Federal Antimonopoly Service of Russia (“FAS”) paid close attention to advertisements of OTC medicines and considered large number cases of violations of advertising legislation by pharmaceutical companies. At the end of 2018, FAS in collaboration with the Association of International Pharmaceutical Manufacturers and other market players, established a guideline on recommended advertising of OTC medicines (“Guideline”) ...
On June 12, 2018, amendments to the Federal law No. 57-FZ, dated April 29, 2008 “On Foreign Investments into Business Entities of Strategic Importance for the Country’s Security, Protection and Defense Support” (“Strategic Investments Law”) came into force ...
An executive order to eliminate the income tax withholding for interest paid abroad on bonds listed in a stock exchange, as well as to grant tax incentives to taxpayers investing in a capital market in Mexico was published in the Federal Official Gazette on January 8, 2019. The following tax incentives were created for productive investment projects: Corporate Bonds ...
