China's National Medical Products Administration (NMPA) released the 2023 Drug Review Annual Report on its official website on February 4, 2024, closely followed by the 2023 Medical Device Registration Annual Report on February 5. According to the public information, more than 60 innovative drugs have been approved by NMPA from 2022 to 2023, and a total of 61 innovative medical devices have been approved in 2023 ...
Entity classification refers to a set of rules used in the U.S. tax system to classify entities for the purposes of the Internal Revenue Code. Once classified, the entity will either be subject to the Code rules for corporations or the Code rules for partnerships. The Canadian tax system, on the other hand, does not have entity classification rules. Instead, the Canadian tax system simply categorizes entities for tax purposes based on their classification under commercial law ...
Since 2013, the National Medical Products Administration ("NMPA")Center for Drug Evaluation("CDE")has been releasing a Drug Review Annual Report ("Report")each year, which summarizes its work on drug review of the previous year ...
It currently appears that Texas may join a growing number of states that have passed laws aimed at increasing tax collection from online retail transactions. On Wednesday, April 27, 2011, the Texas House passed H.B. 2403, which provides that out-of-state retailers that have relationships with certain Texas “affiliated” entities will be deemed to be doing business in Texas for purposes of the sales and use tax. H.B. 2403 will now be sent to the Texas Senate for consideration ...
The so-named “American Taxpayer Relief Act,” now signed by the President after having been passed in the wee hours by the Senate on January 1, 2013, and later that day by the House, may pull the country back from a self-created fiscal/political ditch, but leaves the country at the edge of a fiscal cliff with spending cut issues, debt ceiling issues and undoubtedly more tax issues to be dealt with before March 1, 2013. Overview ...
Back in mid-March, the Department of Labor (DOL) notified key stakeholders of the likelihood it would be issuing new regulations concerning COVID-19. Yesterday, the Occupational Safety and Health Administration (OSHA) of the DOL issued the long-awaited Emergency Temporary Standard (ETS) regarding safety requirements that healthcare employers must implement and adhere to in light of COVID-19 ...
The Occupational Safety and Health Administration (“OSHA”) issued a final rule to “Improve Tracking of Workplace Injuries and Illnesses, “ which requires employers to electronically submit their injury and illness records to OSHA. Specifically, establishments with 250 or more employees must annually submit their Forms 300, 300A, and 301. And, establishments with 20 to 249 employees must annually submit their Form 300A ...
Last week, the Occupational Safety and Health Administration (OSHA) issued a COVID-19 Emergency Temporary Standard (ETS) for employers only in the health care sector in response to President Joe Biden’s January Executive Order on Protecting Worker Health and Safety. The ETS becomes effective on the date it is published in the Federal Register, which is yet to be determined. In addition, OSHA promulgated new non-binding guidance for employers in all other sectors ...
Yesterday, July 22, 2014, the Senate Finance Committee held a hearing at which the so-called corporate inversions of U.S. multinationals were a key topic. The hearing followed U.S. Treasury Secretary Jacob Lew’s July 15 letter to congressional tax writers urging immediate legislative action to stop corporate inversions of U.S. companies. Generally, a corporate inversion is a transaction in which a U.S. multinational group with a U.S. parent corporation restructures so that the U.S ...
Dubai is the fastest growing healthcare market within the GCC and is becoming an increasingly attractive sector for investors. In this inBrief article we explain the key drivers behind this growth and set out the options available to investors wishing to enter the Dubai healthcare market ...
Summary Proposed FASTER Act defines sesame as a major allergen under the Federal Food, Drug and Cosmetic Act; FDA Draft Guidance recommends the declaration of sesame as an ingredient in flavors and spices. Although non-binding, these actions foreshadow the regulation of sesame as a major food allergen in the future. Two recent legislative actions and an FDA publication address emerging concerns about sesame as an allergen. The U.S ...
Brenna K. Legaard is a registered patent attorney with Schwabe, Williamson & Wyatt. Legaard wrote the following op-ed on the use of blockchain technology in health care. When health care professionals and consumers think of blockchain, their minds very likely go to famous cryptocurrencies like Bitcoin. But blockchain technology can be applied to so much more, including to the field of health care ...
On March 8, 2023, the Oregon Senate passed Senate Bill 592, which, if passed by the House and signed by the governor, would significantly increase the penalty amounts that the Oregon Occupational Safety and Health Division (Oregon OSHA) could impose on an employer for workplace safety violations. In addition, SB 592 would require Oregon OSHA to conduct comprehensive inspections of a workplace under specific circumstances, greatly expanding the number of inspections that an employer could face ...
The only thing crystal clear about health care price transparency requirements at the moment is that the government will continue implementing new price transparency laws, regulations, and rules ...
Eligible dental providers may now apply for Provider Relief Funds, but the deadline to do so, July 24, 2020, is quickly approaching. On July 10, 2020, the U.S. Department of Health and Human Services (“HHS”) announced an additional $4 billion in relief payments to healthcare providers and, notably, opened its provider portal to dental providers ...
Earlier this year, Department of Finance (“DOF”) Secretary Carlos G. Dominguez issued RR No. 6-2018 which revoked RR No. 12-2013 and reinstated Section 2.58.5 of RR No. 2-1998, as amended by RR Nos. 14-2002 and 17-2003. Section 2.58.5 of RR No. 2-1998 implements the requirement of withholding of income tax for deductibility of expenses. RR No. 6-2018 was published in the Manila Bulletin on January 23, 2018 and took effect on February 7, 2018. Prior to its amendment by RR No ...
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries ...
On Nov. 8, 2021, the U.S. Department of Health & Human Services Office of the Inspector General (OIG) updated and renamed its Provider Self-Disclosure Protocol. Now called the Health Care Fraud Self-Disclosure Protocol (SDP), the OIG’s revisions are the first changes to the SDP since 2013. We report on the key elements of these changes below ...
On Dec. 21, 2021, the Office of Inspector General (OIG) released a Health & Human Services (HHS) OIG Data Brief on genetic tests provided under Medicare Part B. The goal of the OIG in reviewing this data was “to analyze nationwide trends in genetic tests provided and payments made under Medicare Part B.”[1] As a result of this analysis, the OIG determined that there is a significant risk of overuse and misuse of genetic testing ...
On April 17, 2013, the Health and Human Services Office of Inspector General (OIG) released an Updated Provider Self-Disclosure Protocol (SDP), which replaces the original SDP published in 1998. The SDP is used by providers and suppliers to voluntarily disclose violations of the fraud and abuse laws. According to the OIG, it has received more than 800 disclosures since the SDP’s inception, resulting in more than $280 million in recoveries ...
The Department of Health and Human Services (HHS) released a Special Fraud Alert from the Office of Inspector General (OIG) highlighting the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs sponsored by healthcare companies ...
In the last quarter of 2018, the Office of the Inspector General (OIG) announced that ImmediaDent of Indiana, LLC (ImmediaDent), which operates nine dental care practices, and Samson Dental Partners, LLC (SDP), which provides administrative support to Immediadent, have agreed to pay the United States and the state of Indiana $5.1 million to resolve allegations that they improperly billed Indiana’s Medicaid program ...
Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...
