Since the Department of Health and Human Services (HHS) Provider Relief Funds (PRF) first started arriving in provider bank accounts on April 10, 2020, HHS has stated that it will issue additional guidance “soon” on mandatory reporting requirements on how use of funds must be reported. The PRF funds are among the funds Congress appropriated to reimburse eligible healthcare providers for healthcare-related expenses or lost revenues attributable to COVID-19 ...
The U.S ...
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021. At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules ...
Details regarding a new Medicare payment model for radiation oncology care have been released by the Department of Health and Human Services (HHS). The new Radiation Oncology Model (RO Model) qualifies as an Advanced Alternative Payment Model (APM) and a MIPS APM under the Quality Payment Program. According to this release from HHS, the RO Model aims to “promote quality and financial accountability for providers and suppliers of radiotherapy ...
The Department of Health and Human Services (HHS) has implemented a new Medicare payment model, the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model. The ETC Model was developed to test whether the greater use of home dialysis and kidney transplantation for Medicare beneficiaries with ESRD will reduce Medicare expenditures, while also preserving or enhancing the quality of care furnished to beneficiaries with ESRD ...
A small nonprofit hospice in Idaho became the first healthcare provider to settle a potential violation of the HIPAA Security Rule affecting fewer than 500 individuals. On January 2, 2013, Hospice of North Idaho agreed to a settlement in the amount of $50,000 with the Department of Health and Human Services, Office of Civil Rights (OCR) following an investigation relating to a 2010 breach involving a stolen, unencrypted laptop containing patient information ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
On December 10, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry ...
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 ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable Care Act (ACA) (the Proposed Rule). The Proposed Rule would revise certain provisions of the current Section 1557 rule that federal courts have ruled as likely unlawful, and eliminate the requirement that covered entities publish non-discrimination notices and include taglines in foreign languages on all significant publications ...
The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations (collectively the HIPAA Rules) ...
On Friday, March 13, 2020, the Department of Health and Human Services (HHS) announced several waivers of existing Centers for Medicare and Medicaid (CMS) regulations pursuant to Section 1135(b) of the Social Security Act, including the waiver of certain Emergency Medical Treatment and Active Labor Act (EMTALA) obligations and Medicare conditions of participation during the COVID-19 pandemic ...
Omnibus HIPAA Rule, Including Significant Breach Notification Rule Changes, Released by HHS - The long-awaited final rule modifying the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (the Rule) was released on January 17, 2013 by the Department of Health and Human Services (HHS) ...
Every healthcare provider in the country is under significant operational and financial strain. Those on the front lines of emergency care are working frantically to either increase surge capacity or deal with the surge that has already come. Others are suffering financially from the stoppage of non-emergency procedures and patient visits. In the midst of this unprecedented public health crisis, there is a modicum of good news from a source that is not known for spreading joy ...
The refinancing policies for listed companies on the Shanghai and Shenzhen Stock Exchanges will be revised as a part of the full implementation of the registration-based stock issuance system reform, in addition to the reform of the IPO-related rules ...
The National Pension Commission (PENCOM) recently introduced a new category of fund which complies with sharia principles of investment. The Non-Interest Fund (Fund VI) permits pension contributors and retirees to choose the preferred investment portfolio they would want their pension contributions remitted to ...
On February 1, 2023, the China Securities Regulatory Commission ("CSRC"), the Shanghai Stock Exchange ("SSE"), the Shenzhen Stock Exchange ("SZSE"), and the Beijing Stock Exchange ("BSE") issued for public comments draft rules and regulations (the "Draft Rules") related to the registration-based stock issuance system. The Draft Rules mark the official launch of the full implementation of stock issuance reforms in China ...
On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
On May 9, 2022, National Medical Products Administration (NMPA) issued for public comments a draft revision (the “Draft Revision”) to the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China (the “Regulations”). The public comment period ends on June 6, 2022. The Regulations were last revised and became effective in March 2019 ...
China began legislating the protection of human genetic resources in 1998, at which time the Ministry of Science and Technology (MOST) and the Ministry of Health jointly formulated the Interim Measures for Administration of Human Genetic Resources; however, there had been no corresponding implementing rules to implement it in practice ...
On October 26, 2022, the National Medical Products Administration ("NMPA") issued the newly revised Measures for the Administration of Drug Recalls ("the 2022 Measures") that has just been formally adopted. The former Measures for the Administration of Drug Recalls ("the 2007 Measures") was issued and implemented on December 10, 2007 ...
As the regulation system on human genetic resources ("HGR"), biosecurity and laboratory animals is experiencing continuous improvement, enforcement actions of the Ministry of Science and Technology ("the MOST") have become more active and tight in recent years ...
