The concept of "patient-centered" has become the core guiding principle in current research and development ("R&D") of drugs. "Patient-centered" drug R&D refers to the process of drug discovery, design, implementation and decision-making based on the patient's point of view, with the aim of efficiently developing clinically valuable drugs that better meet the needs of patients ...
Did you know? The Chinese National Intellectual Property Administration (CNIPA) revised Patent Examination Guidelines came into force on 15 January 2021. The changes significantly relax the patentability requirements for inventions in the pharmaceutical, chemical and biotech field. Why does this matter to you? The revised guidelines focus on the examination criteria for novelty and inventive step in relation to the rapidly developing field of chemical and biotech inventions ...
On October 8, 2023, theScientific and Technological Ethics Review Regulation (Trial)("Scientific and Technological Ethics Regulation") was jointly published by the China's Ministry of Science and Technology ("MOST"), the Ministry of Education, the Ministry of Industry and Information Technology, and other seven (7) departments/institutions, which was followed by a press conference held next day by the MOST to respond to media inquiries ("Press Conference") ...
In the past few years China has introduced significant regulatory changes in an effort to modernize its pharmaceutical industry and bring it in line with international standards. These include reorganizing the former State Drug Administration into the State Food and Drug Administration (SFDA), thoroughly amending drug regulation and good manufacturing practice (GMP), enhancing intellectual property protection and changing drug import licensing ...
Quebec is a fertile ground for class actions, with over 550 active cases and between 50 to 100 applications for authorization filed each year. While 2023 marked the fifth anniversary of the ?new? class action division: what is there to watch in 2024? Read on to find out. Opioids and the State: Sanis Health v ...
The Department of Defense (DoD) and the Civilian Agency Acquisition Council (CAAC) have both issued new Class Deviations from the FARs that implement Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors (i.e., the federal contractor vaccine mandate) ...
Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether ...
CMS and OIG Finalize Waivers for ACOs in the Medicare Shared Savings Program Effective October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health & Human Services (“HHS” or “the Department”) finalized the waivers of certain fraud and abuse laws to specified arrangements involving accountable care organizations (“ACOs”) in the Medicare Shared Savings Program (“MSSP”) ...
The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) have responded to the U.S. Senate’s request for information on physician-owned distributorships (PODs). Earlier this summer, a bi-partisan U.S. Senate committee asked CMS and the OIG to study the proliferation of PODs, citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
The Centers for Medicare and Medicaid Services (CMS) announced on March 13, 2020 enhanced penalties for infection control survey non-compliance amid the COVID-19 pandemic.[1] On June 1, 2020, CMS announced significant changes related to nursing home surveys. The new changes require states to complete 100 percent of their Focused Infection Control nursing home surveys by July 31, 2020 ...
A new reimbursement model intended to address healthcare access and availability in rural communities was introduced by The Centers for Medicare & Medicaid Services (CMS) Innovation Center. The Community Health Access and Rural Transformation (CHART) Model will “provide up-front investments and predictable, capitated payments that pay for quality and patient outcomes,” according to CMS ...
On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced updates to its survey process in response to COVID-19 (press release,press release, andmemo). Specifically, as authorized pursuant to section 1135(b)(5) of the Social Security Act, CMS is prioritizing certain surveys and exercising enforcement discretion for all certified provider and supplier types for the next three weeks ...
The Centers for Medicare & Medicaid Services (CMS) announced during a March 19, 2020 teleconference for physicians and teaching hospitals that it does not have the authority to postpone the statutory timeline for the Physician Payments Sunshine Act (Sunshine Act) ...
On April 8, 2021, the Center for Medicare & Medicaid Services (“CMS”) announced a proposed rate increase of 1.3 percent for skilled nursing providers in fiscal year 2022. It is estimated this will result in approximately $444 million increase in payments to skilled nursing facilities (SNF) under Medicare Part A for the fiscal year. This increased payment rate does not incorporate the SNF Value-Based Program (VBP) reductions that CMS estimates to be $184 ...
Recently, the Centers for Medicare & Medicaid Services (CMS) announced it is rescinding the audit determinations for providers notified in January 2021 that had failed to qualify for the “mid-build” exception. CMS took this action due to questions raised by these providers regarding the audit process ...
On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Nursing Home Visitation. CMS issued its initial guidance in March 2020, via memorandum QSO-20-14-NH. Under this memorandum, all visitation by visitors and non-essential health care personnel was restricted, except for situations involving compassionate care, such as end-of-life ...
On April 27, 2021, the Center for Medicare & Medicaid Services (CMS) announced revised guidance for Interim Final Rule, CMS-3401-IFC related to Long-Term Care Facility Testing Requirements and the COVID-19 Focused Survey Tool. CMS published the initial interim final rule with comment period on Aug. 25, 2020 ...
In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...
On April 6, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule in the Federal Register that, among other initiatives and changes to existing policy, allows certain inpatient hospital services to be provided “under arrangements” outside of the hospital. The “March 2020 IFC” is intended to give healthcare providers increased flexibility to respond to the public health emergency created by COVID-19 ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules). This alert is a part of the Dinsmore Health Care practice group’s ongoing summary of the Final Rules ...
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 ...
Federal and state agencies continue to deliver tools and information to help healthcare providers respond to the COVID-19 pandemic since the President declared the COVID-19 outbreak a national emergency. The declaration gave the Secretary of the U.S. Department of Health and Human Services (“HHS”) authority to temporarily waive or modify certain requirements of federal healthcare programs ...
