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 ...
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 ...
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”) ...
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 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 ...
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”) ...
The Financial Services Authority (“OJK”) recently issued OJK Regulation No 37/POJK 04/2018 on equity crowdfunding services. This will allow offers of shares for sale by an issuer directly to investors through an open information technology system (“POJK37/2018”). POJK 37/2018 applies to offers of shares through a Crowdfunding ServicesProvider’s system ...
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 ...
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 ...
Shepherd and Wedderburn, as a collection of individuals and as a business, has put diversity and inclusivity at the heart its organisational culture and values. The business case for fostering diversity and inclusivity in the workplace is compelling ...
IN THIS ARTICLE, GOH HUI WEN LOOKS AT GREEN AND SUSTAINABLE INVESTMENTS IN THE ASEAN REGION. The investment scene in the ASEAN region has been undergoing a transformational change in recent years as it pivots towards a green and sustainable path of development[1]. Demand for sustainable investment opportunities in ASEAN is set to bloom within the next two decades, with the investment opportunity estimated to be worth a whopping USD3 trillion from 2016 to 2030[2] ...
In this article, Tan Wei Xian analyses the new guidelines on registration and conduct of trustees and issuing houses ...
On 18 January 2019, the Electronic Invoicing (Public Contracts etc.) Amendment (Scotland) Regulations 2019 (the Regulations) were laid before the Scottish Parliament. They come into force on 18 April 2019 for central government authorities and bodies established under the National Health Service (Scotland) Act 1978, and on 18 April 2020 in relation to all other contracting authorities and contracting entities ...
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) ...
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 ...
Long before eMortgages, electronic signatures, and mobile apps hit the secured lending scene, Lord Nottingham proposed that the English Parliament pass An Act for Prevention of Frauds and Perjuries in 1677 to prevent nonexistent agreements from being “proved” through false testimony. That statute and its progeny remain an important resource in today’s financial services industry ...
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 ...
Digital economy is a system of economic relations new for the Russian markets. It has emerged due to the development of modern information tech-nologies, that increased the role of information as a market-development resource. Currently, all the regulators pay significant attention to digitalization and IT technologies that might influence the market environment in Russia ...
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 ...
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 ...
Justice Kavanaugh’s first authored opinion as a Supreme Court Justice inHenry Schein, Inc. v. Archer and White Sales, Inc., No. 17-1272, 586 U.S. ____ (2019) further cements the Supreme Court’s stance on arbitration. Over the years, the Supreme Court has consistently held in favor of arbitration and rejected attempts by parties and the lower courts to ignore binding arbitration clauses. For instance, inAT&T Mobility LLC v. Concepcion, 131 S. Ct ...
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 ...
