Over the past several years, the Centers for Medicare and Medicaid Services (CMS) has expanded payment for care management and remote monitoring services in an effort to recognize and pay for non-face-to-face services that...more
7/21/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Medicare Beneficiaries ,
Physician Fee Schedule ,
Physicians ,
Proposed Rules ,
Telehealth
A recent multijurisdictional contractor advisory committee (CAC) meeting held by six of the seven Medicare Administrative Contractors (MACs) gave stakeholders an initial opportunity to provide feedback on the strength of...more
3/6/2023
/ Comment Period ,
Deadlines ,
Health Care Providers ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Physicians ,
Stakeholder Engagement ,
Subject Matter Experts (SMEs) ,
Technology Sector ,
Telehealth ,
Telemedicine
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
9/28/2020
/ Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Labeling ,
Motion for Reconsideration ,
Motion To Stay ,
Off-Label Use ,
Proposed Rules ,
Public Health Service Act ,
Repeal
On January 7, 2020, the US Food and Drug Administration (FDA) announced that it will hold a public meeting on March 27 to discuss possible Agency-level approaches to modernizing FDA’s data strategy, including approaches to...more
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more
10/17/2019
/ 21st Century Cures Act ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Public Comment ,
Regulatory Oversight ,
Software
On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more
9/10/2015
/ Biologics ,
Biosimilars ,
Comment Period ,
Draft Guidance ,
Drug Safety ,
Federal Register ,
Food and Drug Administration (FDA) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
Public Health Service Act ,
World Health Organization