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 ...
2018 has passed; it was full of events and changes in legislation. We would like to share the main trends in registration of business in Russia in 2018 with you. Federal Tax Service (hereinafter the “FTS”) continued its campaign on introducing records on non-reliable data about business into the Unified State Register of Legal Entities (hereinafter “USRLE”), even in respect of the compliant businesses ...
The regulation of Transfer Pricing is one of the mechanisms through which the Directorate General of Revenue (DGI) seeks to avoid the erosion of the tax base. In Panama, it is regulated in the Fiscal Code in its Chapter IX from Article 762-A to 762-Ñ. The obligation on the issue of Transfer Pricing and specifically with the study is generated since the 2011 period ...
The UK government has announced changes to legislation to reduce the risk of fraud, violence or intimidation faced by company directors as a result of having their residential addresses on the public record. For a number of years, directors have been able to keep their residential address details private by making use of a separate service address, often the company's registered office ...
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”) ...
Now that the holidays are in the rearview and business as usual has begun to pick up where it left off, it’s time for public companies to do a deep download of key securities law updates and business developments of the past year so they are positioned for success in 2019. Below is a review of the 2018 proxy season, along with a summary of new and anticipated changes that may impact reporting and disclosure requirements for the 2019 proxy season ...
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule redesigning the Medicare Accountable Care Organization (ACO) program via a new Pathways to Success ACO model. [1]See83 FR 67816 (Dec. 31, 2018). CMS stated five goals for this redesign: ACO Accountability, Competition, Engagement, Integrity, and Quality ...
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 ...
Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...
In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...
On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1] The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule ...
The next 60-day regular session of the West Virginia Legislature commences on Wednesday, January 9, 2019. While much of the nation seemed transfixed by the recent electoral changes, the most significant political change in the West Virginia Legislature actually preceded the 2018 general election. Indeed, the House of Delegates elected a new Speaker, Roger Hanshaw (R-Clay), in August 2018 to replace Tim Armstead who resigned to accept an appointment to the Supreme Court of Appeals ...
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 ...
Why is April 1, 2019 Important? April 1, 2019 is the first day U.S. Citizenship and Immigration Services (USCIS) may accept H-1B specialty worker petitions for the next fiscal year, which begins October 1, 2019 ...
The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices ...
On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...
Law No. 21,121 (the “Law”), which came into force on November 20, 2018, amends the Criminal Code, Law No. 20,393 on Criminal Liability of Legal Entities, and Law No. 19,913 on Money Laundering, in connection with various criminal conducts relating to corruption and conflicts of interest. The following is a summary of the main aspects of the Law: 1.Domestic Passive and Active Bribery ...
Background The UK invoked the exit procedure under Article 50 of the Treaty on European Union in March 2017. Unless the UK's decision is withdrawn or the period is extended, this will become effective in a little over 80 days ...
As one of the final acts of its 99th Legislative Session, the Michigan Legislature passed amendments to the Medical Marihuana Facilities Licensing Act (MMFLA), as well as changes to the Marihuana Tracking Act. These amendments were signed by outgoing Governor Rick Snyder on December 28, 2018, with the MMFLA amendments effective January 1. The Tracking Act amendments took effect immediately ...
The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331 ...
On the last day of the legislative session, the Michigan Legislature passed House Bills 6330, 6331, and 6380 to create the Industrial Hemp Research and Development Act (IHRDA). If signed by the Governor, IHRDA will require the registration of industrial hemp growers and processors as a prerequisite to grow or sell industrial hemp. Oversight authority is given to the Michigan Department of Agriculture and Rural Development (MDARD) ...
On December 23, 2018, new State Medical Board of Ohio regulations became effective which marked another change in the legal standards governing provider use of opiates for treatment of pain ...
